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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-38624

 

Vaccinex, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

16-1603202

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

1895 Mount Hope Avenue

Rochester, New York

14620

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code: (585) 271-2700

 

Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value

VCNX

Nasdaq Capital Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

 

 

 

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

 

Emerging growth company

 

 

 

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

 

As of November 12, 2024, the registrant had 2,599,728 shares of common stock, $0.0001 par value per share, outstanding.

 

 


 

 

VACCINEX, INC.

FORM 10-Q

TABLE OF CONTENTS

 

 

 

 

Page

 

 

 

 

 

PART I – FINANCIAL INFORMATION

 

 

 

 

 

 

 

 

 

 

Item 1.

Financial Statements

 

3

 

 

 

 

 

Condensed Balance Sheets (Unaudited)

 

3

 

 

 

 

Condensed Statements of Operations and Comprehensive Loss (Unaudited)

 

4

 

 

 

 

 

Condensed Statements of Stockholders’ Equity (Deficit) (Unaudited)

 

5

 

 

 

 

Condensed Statements of Cash Flows (Unaudited)

 

6

 

 

 

 

Notes to Condensed Financial Statements (Unaudited)

 

7

 

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

25

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

37

 

 

 

 

Item 4.

Controls and Procedures

 

37

 

 

 

 

 

 

 

 

 

PART II – OTHER INFORMATION

 

 

 

 

 

 

 

 

 

 

Item 1A.

Risk Factors

 

38

 

 

 

 

Item 6.

Exhibits

 

40

 

 

 

 

Signatures

 

41

 

2


 

 

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

VACCINEX, INC.

Condensed Balance Sheets (Unaudited)

(in thousands, except share and per share data)

 

 

 

As of
September 30, 2024

 

 

As of
December 31, 2023

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

2,906

 

 

$

1,535

 

Accounts receivable

 

 

985

 

 

 

961

 

Prepaid expenses and other current assets

 

 

852

 

 

 

853

 

Derivative asset

 

 

14

 

 

 

-

 

Total current assets

 

 

4,757

 

 

 

3,349

 

Property and equipment, net

 

 

82

 

 

 

136

 

Operating lease right-of-use asset

 

 

15

 

 

 

146

 

TOTAL ASSETS

 

$

4,854

 

 

$

3,631

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,865

 

 

$

2,039

 

Accrued expenses

 

 

1,200

 

 

 

1,242

 

Deferred revenue

 

 

51

 

 

 

63

 

Current portion of long-term debt

 

 

44

 

 

 

75

 

Operating lease liability

 

 

15

 

 

 

146

 

Warrant liability

 

 

-

 

 

 

2,351

 

Total current liabilities

 

 

6,175

 

 

 

5,916

 

Long-term debt

 

 

-

 

 

 

26

 

TOTAL LIABILITIES

 

 

6,175

 

 

 

5,942

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

Convertible preferred stock (Series A), par value of $0.001 per share; 10,000,000 shares authorized, 10 shares issued and outstanding as of September 30, 2024, and no shares authorized, issued or outstanding as of December 31, 2023; with aggregate liquidation preference of $1,750,000 and $0 as of September 30, 2024 and December 31, 2023, respectively

 

 

1,522

 

 

 

-

 

Common stock, par value of $0.0001 per share; 100,000,000 shares authorized
 as of September 30, 2024, and December 31, 2023;
2,599,733 and 892,622
 shares issued as of September 30, 2024 and December 31, 2023, respectively;
 
2,599,728 and 892,617 shares outstanding as of September 30, 2024
 and December 31, 2023, respectively

 

 

1

 

 

 

-

 

Additional paid-in capital

 

 

352,354

 

 

 

337,627

 

Treasury stock, at cost; 5 shares of common stock as of September 30, 2024, and December 31, 2023, respectively

 

 

(11

)

 

 

(11

)

Accumulated deficit

 

 

(355,187

)

 

 

(339,927

)

TOTAL STOCKHOLDERS’ EQUITY/(DEFICIT)

 

 

(1,321

)

 

 

(2,311

)

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

4,854

 

 

$

3,631

 

 

The accompanying notes are an integral part of these condensed financial statements.

3


 

 

VACCINEX, INC.

Condensed Statements of Operations and Comprehensive Loss (Unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

52

 

 

$

20

 

 

$

388

 

 

$

570

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,165

 

 

 

4,355

 

 

 

10,412

 

 

 

13,217

 

General and administrative

 

 

1,439

 

 

 

1,499

 

 

 

5,324

 

 

 

5,250

 

Total costs and expenses

 

 

4,604

 

 

 

5,854

 

 

 

15,736

 

 

 

18,467

 

Loss from operations

 

 

(4,552

)

 

 

(5,834

)

 

 

(15,348

)

 

 

(17,897

)

Interest expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1

)

Loss on settlement of warrants

 

 

(1,106

)

 

 

-

 

 

 

(1,106

)

 

 

-

 

Financing costs - warrant liabilities

 

 

-

 

 

 

-

 

 

 

(28

)

 

 

-

 

Change in fair value of warrant liabilities

 

 

(71

)

 

 

-

 

 

 

1,291

 

 

 

-

 

Change in fair value of derivative asset

 

 

-

 

 

 

-

 

 

 

(81

)

 

 

-

 

Other income (expense), net

 

 

(3

)

 

 

922

 

 

 

12

 

 

 

964

 

Loss before provision for income taxes

 

 

(5,732

)

 

 

(4,912

)

 

 

(15,260

)

 

 

(16,934

)

Provision for income taxes

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Net loss attributable to Vaccinex, Inc. common stockholders

 

$

(5,732

)

 

$

(4,912

)

 

$

(15,260

)

 

$

(16,934

)

Comprehensive loss

 

$

(5,732

)

 

$

(4,912

)

 

$

(15,260

)

 

$

(16,934

)

Net loss per share attributable to Vaccinex, Inc. common
   stockholders, basic and diluted

 

$

(2.83

)

 

$

(15.25

)

 

$

(8.85

)

 

$

(59.95

)

Weighted-average shares used in computing net loss per share
   attributable to Vaccinex, Inc. common stockholders, basic and
   diluted

 

 

2,026,920

 

 

 

322,153

 

 

 

1,724,088

 

 

 

282,467

 

 

The accompanying notes are an integral part of these condensed financial statements.

4


 

VACCINEX, INC.

Condensed Statements of Stockholders’ Equity (Deficit) (Unaudited)

(in thousands, except share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred Stock

 

 

Common Stock

 

 

 

 

 

Treasury Stock

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional
Paid-in
Capital

 

 

Common
Stock
Shares

 

 

Amount

 

 

Accumulated
Deficit

 

 

Total
Stockholders’
Equity/(Deficit)

 

Balance as of January 1, 2023

 

 

-

 

 

$

-

 

 

 

237,532

 

 

$

-

 

 

$

324,880

 

 

 

5

 

 

$

(11

)

 

$

(319,676

)

 

$

5,193

 

Issuance of common stock

 

 

-

 

 

 

-

 

 

 

23,693

 

 

 

-

 

 

 

2,040

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2,040

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

129

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

129

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(4,962

)

 

 

(4,962

)

Balance as of March 31, 2023

 

 

-

 

 

 

-

 

 

 

261,225

 

 

 

-

 

 

 

327,049

 

 

 

5

 

 

 

(11

)

 

 

(324,638

)

 

 

2,400

 

Issuance of Common Shares

 

 

-

 

 

 

-

 

 

 

51,486

 

 

 

-

 

 

 

4,111

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

4,111

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

126

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

126

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(7,060

)

 

 

(7,060

)

Balance as of June 30, 2023

 

 

-

 

 

 

-

 

 

 

312,711

 

 

 

-

 

 

 

331,286

 

 

 

5

 

 

 

(11

)

 

 

(331,698

)

 

 

(423

)

Issuance of Common Shares

 

 

-

 

 

 

-

 

 

 

34,327

 

 

 

-

 

 

 

1,351

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,351

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

115

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

115

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(4,912

)

 

 

(4,912

)

Balance as of September 30, 2023

 

 

-

 

 

$

-

 

 

 

347,038

 

 

$

-

 

 

$

332,752

 

 

 

5

 

 

$

(11

)

 

$

(336,610

)

 

$

(3,869

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred Stock

 

 

Common Stock

 

 

 

 

 

Treasury Stock

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional
Paid-in
Capital

 

 

Common
Stock
Shares

 

 

Amount

 

 

Accumulated
Deficit

 

 

Total
Stockholders’
Equity/(Deficit)

 

Balance as of January 1, 2024

 

 

-

 

 

$

-

 

 

 

892,622

 

 

$

-

 

 

$

337,627

 

 

 

5

 

 

$

(11

)

 

$

(339,927

)

 

$

(2,311

)

Issuance of common stock

 

 

-

 

 

 

-

 

 

 

64,816

 

 

 

-

 

 

 

2

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

96

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

96

 

Issuance of common stock and pre-funded warrants in private placement offerings

 

 

-

 

 

 

-

 

 

 

626,867

 

 

 

1

 

 

 

4,223

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

4,224

 

Issuance of warrants in private placement offerings

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

750

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

750

 

Issuance of warrants

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

556

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

556

 

Issuance of preferred stock

 

 

10

 

 

 

1,236

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,236

 

Reclassification of public warrants, as amended

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,199

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,199

 

Reclassification of private placement warrants, as amended

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

800

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

800

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(3,897

)

 

 

(3,897

)

Balance as of March 31, 2024

 

 

10

 

 

 

1,236

 

 

 

1,584,305

 

 

 

1

 

 

 

345,253

 

 

 

5

 

 

 

(11

)

 

 

(343,824

)

 

 

2,655

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

112

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

112

 

Amortization of preferred stock discount

 

 

-

 

 

 

143

 

 

 

-

 

 

 

-

 

 

 

(143

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of restricted stock

 

 

-

 

 

 

-

 

 

 

543

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,631

)

 

 

(5,631

)

Balance as of June 30, 2024

 

 

10

 

 

 

1,379

 

 

 

1,584,848

 

 

 

1

 

 

 

345,222

 

 

 

5

 

 

 

(11

)

 

 

(349,455

)

 

 

(2,864

)

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

76

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

76

 

Amortization of preferred stock discount

 

 

-

 

 

 

143

 

 

 

-

 

 

 

-

 

 

 

(143

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Exercise of warrants

 

 

-

 

 

 

-

 

 

 

1,014,885

 

 

 

-

 

 

 

5,211

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

5,211

 

Issuance of warrants

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,988

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,988

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,732

)

 

 

(5,732

)

Balance as of September 30, 2024

 

 

10

 

 

$

1,522

 

 

 

2,599,733

 

 

$

1

 

 

$

352,354

 

 

 

5

 

 

$

(11

)

 

$

(355,187

)

 

$

(1,321

)

 

The accompanying notes are an integral part of these condensed financial statements.

5


 

 

VACCINEX, INC.

Condensed Statements of Cash Flows (Unaudited)

(in thousands)

 

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

 

 

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

Net loss

 

$

(15,260

)

 

$

(16,934

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation

 

 

77

 

 

 

92

 

Stock-based compensation

 

 

284

 

 

 

370

 

Change in fair value of warrant liability

 

 

(1,291

)

 

 

-

 

Change in fair value of derivative asset

 

 

81

 

 

 

-

 

Loss on settlement of warrants

 

 

1,106

 

 

 

-

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

(24

)

 

 

(758

)

Prepaid expenses and other current assets

 

 

1

 

 

 

17

 

Accounts payable

 

 

2,826

 

 

 

2,707

 

Accrued expenses

 

 

(42

)

 

 

864

 

Deferred revenue

 

 

(12

)

 

 

-

 

Net cash used in operating activities

 

 

(12,254

)

 

 

(13,642

)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

Purchase of property and equipment

 

 

(22

)

 

 

(67

)

Net cash used in investing activities

 

 

(22

)

 

 

(67

)

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

Proceeds from issuance of common stock, and
pre-funded warrants in private placement offerings

 

 

2,529

 

 

 

-

 

Proceeds from exercise of warrants

 

 

5,920

 

 

 

-

 

Proceeds from issuance of warrants in private placement offerings

 

 

1,113

 

 

 

-

 

Proceeds from private offering of common stock

 

 

-

 

 

 

6,234

 

Payments of long-term debt

 

 

(58

)

 

 

(57

)

Proceeds from issuance of preferred stock and accompanying warrants

 

 

1,697

 

 

 

-

 

Proceeds from issuance of common stock, and
private placement warrants

 

 

2,446

 

 

 

-

 

Proceeds from issuance of common stock

 

 

-

 

 

 

1,268

 

Net cash provided by financing activities

 

 

13,647

 

 

 

7,445

 

NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS

 

 

1,371

 

 

 

(6,264

)

CASH AND CASH EQUIVALENTS–Beginning of period

 

 

1,535

 

 

 

6,391

 

CASH AND CASH EQUIVALENTS–End of period

 

$

2,906

 

 

$

127

 

SUPPLEMENTAL DISCLOSURES OF NONCASH INVESTING AND
   FINANCING ACTIVITIES:

 

 

 

 

 

 

Warrant inducement (transaction costs incurred but not paid)

 

$

297

 

 

 

 

 

The accompanying notes are an integral part of these condensed financial statements.

6


 

VACCINEX, INC.

Notes to Condensed Financial Statements (Unaudited)

Note 1. COMPANY AND NATURE OF BUSINESS

Vaccinex, Inc. (the “Company”) was incorporated in Delaware in April 2001 and is headquartered in Rochester, New York. The Company is a clinical-stage biotechnology company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, including neurodegenerative diseases, cancer, and autoimmune disorders. Since its inception, the Company has devoted substantially all of its efforts toward product research, manufacturing and clinical development, and raising capital.

The Company is subject to a number of risks and uncertainties common to other early-stage biotechnology companies including, but not limited to, dependency on the successful development and commercialization of its product candidates, rapid technological change and competition, dependence on key personnel and collaborative partners, uncertainty of protection of proprietary technology and patents, clinical trial uncertainty, fluctuation in operating results and financial performance, the need to obtain additional funding, compliance with governmental regulations, technological and medical risks, management of growth and effectiveness of marketing by the Company. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability.

Going Concern

These condensed financial statements have been prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

The Company has incurred significant losses and negative cash flows from operations since inception and expects to incur additional losses until such a time it can generate significant revenue from the commercialization of its product candidates. The Company reported cash used in operations of $12.3 million for the nine months ended September 30, 2024, and an accumulated deficit of $355.2 million as of September 30, 2024. Given the Company’s projected operating requirements and its existing cash and cash equivalents, the Company is projecting insufficient liquidity to sustain its operations and meet its obligations through one year following the date that the condensed financial statements are issued. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern.

In response to these conditions, management is currently evaluating different strategies to obtain the required funding of future operations. Financing strategies may include, but are not limited to, the public or private sale of equity, debt financing or funds from other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. There can be no assurances that the Company will be able to secure additional financing, or if available, that it will be sufficient to meet its needs or on favorable terms. Because management’s plans have not yet been finalized and are not within the Company’s control, the implementation of such plans cannot be considered probable. As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern.

The condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

 

7


 

Note 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation and Consolidation

The accompanying unaudited condensed financial statements reflect the accounts and operations of the Company and have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information (Accounting Standards Codification (“ASC”) 270, Interim Reporting) and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, these financial statements do not include all of the information necessary for a full presentation of financial position, results of operations, and cash flows in conformity with GAAP. In the opinion of management, the condensed financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented.

These condensed financial statements should be read in conjunction with the Company’s audited financial statements and related notes included in the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2023, filed with the SEC on April 25, 2024.

Common Stock Reverse Splits

On September 25, 2023, the Company effected a 1-for-15 reverse stock split of its issued shares of common stock. On February 19, 2024, the Company effected a second reverse split of shares of the Company's common stock on a 1-for-14 basis. All per share amounts, common shares outstanding, warrants, and stock-based compensation amounts for all periods presented have been retroactively adjusted to reflect these reverse stock splits. The shares of common stock retain a par value of $0.0001 per share.

Use of Estimates

These condensed financial statements have been prepared in conformity with U.S. GAAP. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the condensed financial statements and the reported amount of expenses during the reporting period. Such management estimates include those relating to assumptions used in the valuation of stock option awards, valuation of the warrant liabilities, valuation of the derivative asset, and valuation allowances against deferred income tax assets. Actual results could differ from those estimates.

Convertible Preferred Stock

In March 2024, the Company issued shares of a newly designated series of convertible preferred stock (see Note 9). The convertible preferred stock contained embedded redemption features requiring bifurcation and separate accounting apart from the convertible preferred stock host instrument. The Company recorded the fair value of the embedded redemption features as a derivative asset on the Company’s balance sheets in accordance with ASC Topic 815, Derivatives and Hedging. See Note 4 for the key inputs used in the fair value measurements of the derivative asset.

Fair Value of Financial Instruments

Financial instruments consist of cash, accounts receivable, derivative asset, accounts payable, accrued liabilities, long-term debt, warrant liabilities, and convertible preferred stock. Cash, accounts receivable, accounts payable, accrued liabilities, debt, and convertible preferred stock are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date of such amounts. Warrant liabilities and the derivative asset are measured at fair value on a recurring basis with the assumptions discussed in Note 4.

8


 

Concentration of Credit Risk, Other Risks and Uncertainties

The Company is subject to a number of risks, including, but not limited to, the lack of available capital; the possible delisting of our common stock from Nasdaq; possible failure of preclinical testing or clinical trials; inability to obtain regulatory approval of product candidates; competitors developing new technological innovations; potential interruptions in the manufacturing and commercial supply operations; unsuccessful commercialization strategy and launch plans for its proprietary drug candidates; risks inherent in litigation, including purported class actions; market acceptance of the Company’s products; and protection of proprietary technology.

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents. Cash equivalents are deposited in interest-bearing money market accounts. Although the Company deposits its cash with multiple financial institutions, cash balances may occasionally be in excess of the amounts insured by the Federal Deposit Insurance Corporation. Management believes the financial risk associated with these balances is minimal and has not experienced any losses to date.

The Company has historically raised capital in transactions with investors that include members of its board of directors and entities controlled by certain board members. As such, the Company's directors, directly and indirectly, control a significant ownership percentage of the Company. The Company can provide no assurances that future financing will be available in sufficient amounts or on terms acceptable to it or that its directors or entities controlled by certain board members will be willing or able to participate in future capital raises by the Company.

The Company depends on third-party manufacturers for the manufacture of drug substances and drug product for clinical trials. The Company also relies on certain third parties for its supply chain. Disputes with these third- party manufacturers or shortages in goods or services from third-party suppliers could delay the manufacturing of the Company’s product candidates and adversely impact its results of operations.

Recently Issued Accounting Pronouncements

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 requires disclosure of additional categories of information about federal, state, and foreign income taxes in the rate reconciliation table and more details about the reconciling items in some categories if items meet a quantitative threshold. The ASU requires entities to disclose income taxes paid, net of refunds, disaggregated by federal (national), state and foreign taxes for annual periods and to disaggregate the information by jurisdiction based on a quantitative threshold. The guidance makes several other changes to the disclosure requirements. The ASU is required to be applied prospectively, with the option to apply it retrospectively. The ASU is effective for fiscal years beginning after December 15, 2024. The Company is currently assessing the impact of the adoption of this guidance on its financial statements and disclosures.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. In addition, the ASU enhances interim disclosure requirements, clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, and contains other disclosure requirements. The ASU does not change how an entity identifies its operating segments, aggregates those operating segments, or applies the quantitative thresholds to determine its reportable segments. The ASU is required to be applied retrospectively to all periods presented in the financial statements. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently assessing the impact of the adoption of this guidance on its financial statements and disclosures.

9


 

 

Note 3. BALANCE SHEET COMPONENTS

Property and Equipment

Property and equipment consist of the following (in thousands):

 

 

 

As of
September 30, 2024

 

 

As of
December 31, 2023

 

Leasehold improvements

 

$

3,277

 

 

$

3,277

 

Research equipment

 

 

3,373

 

 

 

3,351

 

Furniture and fixtures

 

 

350

 

 

 

350

 

Computer equipment

 

 

250

 

 

 

250

 

Property and equipment, gross

 

 

7,250

 

 

 

7,228

 

Less: accumulated depreciation and amortization

 

 

(7,168

)

 

 

(7,091

)

Property and equipment, net

 

$

82

 

 

$

136

 

 

Depreciation expense related to property and equipment was $24,000 and $77,000 for the three and nine months ended September 30, 2024 and $31,000 and $92,500 for the three and nine months ended September 30, 2023, respectively.

 

Accrued Expenses

Accrued expenses consist of the following (in thousands):

 

 

 

As of
September 30, 2024

 

 

As of
December 31, 2023

 

 

 

 

 

 

 

 

Accrued clinical trial cost

 

$

649

 

 

$

853

 

Accrued payroll and related benefits

 

 

238

 

 

 

295

 

Accrued consulting and legal

 

 

204

 

 

 

58

 

Accrued other

 

 

109

 

 

 

36

 

Accrued expenses

 

$

1,200

 

 

$

1,242

 

 

Note 4. FAIR VALUE MEASUREMENTS OF FINANCIAL MEASUREMENTS

 

Assets and Liabilities Measured at Fair Value on a Nonrecurring Basis

Assets and liabilities recorded at fair value on a nonrecurring basis in the condensed balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Financial instruments consist of cash, accounts receivable, accounts payable, accrued liabilities, and long-term debt. Cash, accounts receivable, accounts payable, accrued liabilities, and debt are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date of such amounts.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

Fair value measurement standards also apply to certain financial assets and liabilities that are measured at fair value on a recurring basis (each reporting period). For the Company, these financial assets and liabilities include its cash equivalents deposited in money market funds, warrant liabilities, and the derivative asset. The Company does not have any nonfinancial assets or liabilities that are measured at fair value on a recurring basis.

The assets’ or liabilities’ fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

10


 

The following tables set forth the fair value of the Company’s financial assets and liabilities by level within the fair value hierarchy (in thousands):

 

 

 

As of September 30, 2024

 

 

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Money market fund

 

$

900

 

 

$

900

 

 

$

-

 

 

$

-

 

Derivative asset

 

 

14

 

 

 

-

 

 

 

-

 

 

 

14

 

Total Financial Assets

 

$

914

 

 

$

900

 

 

$

-

 

 

$

14

 

 

 

 

As of December 31, 2023

 

 

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Money market fund

 

$

1,337

 

 

$

1,337

 

 

$

-

 

 

$

-

 

Total Financial Assets

 

$

1,337

 

 

$

1,337

 

 

$

-

 

 

$

-

 

 

 

 

As of September 30, 2024

 

 

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liabilities - public warrants

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

Warrant liabilities - private placement warrants

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Total Financial Liabilities

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

 

 

As of December 31, 2023

 

 

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liabilities - public warrants

 

$

2,275

 

 

$

-

 

 

$

-

 

 

$

2,275

 

Warrant liabilities - private placement warrants

 

 

76

 

 

 

-

 

 

 

-

 

 

 

76

 

Total Financial Liabilities

 

$

2,351

 

 

$

-

 

 

$

-

 

 

$

2,351

 

 

The Company did not transfer any assets or liabilities measured at fair value on a recurring basis to or from Level 1, Level 2, and Level 3 during either of the nine months ended September 30, 2024, and 2023.

 

Fair Value Measurement of Warrant Liabilities

The Company uses the Black-Scholes pricing model to determine the fair value of its warrant liabilities using Level 3 inputs. Inputs used to determine the estimated fair value of the warrant liabilities include the fair value of the underlying stock at the valuation date, the term of the warrants, and the expected volatility of the underlying stock. The significant unobservable input used in the fair value measurement of the warrant liabilities is the estimated term of the warrants.

The key inputs into the respective valuation models used to estimate the fair value of the warrant liabilities at September 30, 2024, were as follows:

 

 

 

 

 

 

 

 

Public Warrants

 

 

Private Placement Warrants

 

 

 

Low

 

 

High

 

 

Low

 

 

High

 

Risk-free interest rate

 

 

3.81

%

 

 

5.40

%

 

 

4.08

%

 

 

5.40

%

Volatility

 

 

83

%

 

 

130

%

 

 

83

%

 

 

130

%

Dividend yield

 

 

0

%

 

 

0

%

 

 

0

%

 

 

0

%

Expected term (years)

 

 

0.003

 

 

 

4.760

 

 

 

0.003

 

 

 

5.010

 

Share price

 

$

6.000

 

 

$

9.310

 

 

$

6.000

 

 

$

9.310

 

The key inputs into the respective valuation models used to estimate the fair value of the warrant liabilities at December 31, 2023, were as follows:

11


 

 

 

 

 

 

 

 

Public Warrants

 

 

Private Placement Warrants

 

 

 

Low

 

 

High

 

 

Low

 

 

High

 

Risk-free interest rate

 

 

3.81

%

 

 

5.42

%

 

 

3.81

%

 

 

5.33

%

Volatility

 

 

99

%

 

 

113

%

 

 

102

%

 

 

113

%

Dividend yield

 

 

0

%

 

 

0

%

 

 

0

%

 

 

0

%

Expected term (years)

 

 

0.75

 

 

 

5.01

 

 

 

0.75

 

 

 

5.01

 

Share price

 

$

9.310

 

 

$

13.160

 

 

$

9.310

 

 

$

12.880

 

The following table summarizes the changes in fair value of the Company’s warrant liabilities that are recognized in the change in fair value of the warrant liabilities in the accompanying condensed statements of operations and comprehensive loss during the nine months ended September 30, 2024 (in thousands):

 

 

 

 

 

 

Public Warrants

 

 

Private Placement Warrants

 

 

Total

 

Warrant liabilities as of January 1, 2024

 

$

2,275

 

 

$

76

 

 

$

2,351

 

Issuance of warrants

 

 

-

 

 

 

1,113

 

 

 

1,113

 

Reclassified as equity

 

 

(1,199

)

 

 

(800

)

 

 

(1,999

)

Cancellation of warrants

 

 

(77

)

 

 

-

 

 

 

(77

)

Exercise of warrants

 

 

(90

)

 

 

(7

)

 

 

(97

)

Change in fair value

 

 

(909

)

 

 

(382

)

 

 

(1,291

)

Warrant liabilities as of September 30, 2024

 

$

-

 

 

$

-

 

 

$

-

 

 

There were no warrant liabilities reported in the Company's condensed balance sheet at September 30, 2023, or change in fair value of warrant liabilities in the accompanying condensed statements of operations and comprehensive loss during the nine months ended September 30, 2023.

 

Fair Value Measurement of the Derivative Asset

The fair value of the derivative asset is determined using a binomial lattice valuation model (“BLM”). The application of the BLM requires the use of several inputs and significant unobservable assumptions, including volatility. Significant judgment is required in determining the expected volatility of the Company’s derivative asset.

The following table provides quantitative information regarding measurement inputs used to estimate the fair value of the Level 3 asset at:

 

 

 

September 30, 2024

 

Risk-free interest rate

 

 

5.12

%

Expected volatility

 

 

40.00

%

Expected term (in years)

 

 

0.50

 

Exercise price (per share)

 

$

7.77

 

Number of shares

 

 

10

 

 

The following table presents the changes in the derivative asset during the nine months ended September 30, 2024 (in thousands):

 

 

 

 

 

Derivative asset as of January 1, 2024

 

$

-

 

Issuance of convertible preferred stock

 

 

95

 

Change in fair value

 

 

(81

)

Derivative asset as of September 30, 2024

 

$

14

 

 

12


 

 

Note 5. COLLABORATION AGREEMENTS

Surface Oncology, Inc.

In November 2017, the Company entered into a research collaboration and license option agreement with Surface Oncology, Inc. (“Surface”) to identify and select antibodies against two target antigens, using the Company’s proprietary technology as described in the agreement. Under the agreement, Surface may purchase exclusive options, exercisable by providing a written notice to the Company, to obtain (i) an exclusive product license to make, use, sell and import products incorporating antibodies targeting the first antigen and (ii) an exclusive research tool license to use antibodies targeting the second antigen to perform research. Surface purchased the first option and exercised the second option, and we entered into an exclusive research tool license agreement with Surface in the third quarter of 2019.

Under the research collaboration and license option agreement, Surface paid an upfront technology access fee of $250,000 and makes milestone payments upon completion of each of four designated milestones for the first target antigen specified in the agreement. For the second target antigen, Surface is obligated to make payments to the Company based on time incurred by the Company in the conduct of the work plan described in the agreement. Surface is required to reimburse the Company for expenses incurred (i) in the conduct of the work plan as detailed in the research funding budget and (ii) for patent filings and prosecution of the Company’s program intellectual property as described in the agreement. The exercise of each option would also entail a license fee and annual maintenance fees, and in the case of the product license, royalties, and additional milestone payments. This agreement will expire upon the latest of the expiration of both research programs and all evaluation and testing periods. During the nine months ended September 30, 2023, the Company recorded $500,000 of revenue for achievement of a milestone event. In 2023 Surface terminated this exclusive research license agreement, for the first target, and therefore will not be required to pay the maintenance fee any longer. Surface Oncology has sublicensed this program for the second target to Coherus BioSciences, Inc. (“Coherus”), which is actively continuing phase 1/2 development of the second target. Coherus has assumed responsibility for the payment of the maintenance fee and other fees contemplated by the research collaboration and license option agreement for the second target.

 

Note 6. COMMITMENTS AND CONTINGENCIES

Nasdaq Deficiency Notice

On April 11, 2024, the Company received a letter from the Listing Qualifications staff of Nasdaq notifying the Company that based on the financial statements contained in its Form 10-K for the year-ended December 31, 2023, it no longer complies with the requirement under Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders’ equity for continued listing on the Nasdaq Capital Market (the “Equity Standard”) or the alternative requirements of having a market value of listed securities of $35.0 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years (the “Alternative Standards”), and may be subject to delisting. The notification letter had no immediate effect on the Company’s listing on the Nasdaq Capital Market and the Company timely submitted a plan to regain compliance with the Equity Standard.

On June 5, 2024, Nasdaq notified the Company that it has been provided an extension to regain and evidence compliance with the Equity Standard on or before September 30, 2024. As of September 30, 2024, we have a stockholders' deficit of $1.3 million. On October 7, 2024, the Company received a letter from the Nasdaq Listing Staff stating that the Company had not regained compliance with the Equity Standard or the Alternatives Standards and that, as a result, unless the Company timely requested an appeal of this determination to a Nasdaq Hearings Panel, Nasdaq would move to suspend trading of the Company’s common stock and to have the Company’s securities delisted from the Nasdaq Capital Market. The Company timely appealed the determination, which automatically stayed any suspension or delisting action pending the Hearings Panel’s decision and the expiration of any additional extension period granted by the Hearings Panel following the hearing set for December 5, 2024. As a result, the Company’s common stock is expected to remain listed on the Nasdaq Capital Market through at least that

13


 

time. However, there can be no assurance that the Hearings Panel will grant the Company’s request for continued listing or that the Company will be able to demonstrate compliance with the Equity Standard or the Alternative Standards within any additional compliance period that may be granted by the Hearings Panel.

Cancellation of Warrants

A holder of certain of the warrants that we called for cancellation has notified the Company that it believes that the warrants it held are still outstanding. The number of shares represented by these canceled warrants represents approximately 8% of our outstanding shares as of September 30, 2024, on a pre-issuance basis. Should this misunderstanding continue and a resolution be required and reached, there could be adverse impacts to the Company, including the payment of damages or the issuance of additional shares of common stock. While the Company believes that it has meritorious defenses with respect to this matter, and intends to vigorously defend its position, the process of resolving these matters is inherently uncertain and may develop over a long period of time, and so it is not possible to predict the ultimate resolution of such matter.

Other Contingencies

The Company is subject to claims and assessments from time to time in the ordinary course of business. The Company records a provision for a liability when it believes that it is both probable that a liability has been incurred and the amount can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount.

In the normal course of business, the Company may become involved in legal proceedings. The Company will accrue a liability for such matters when it is probable that a liability has been incurred and the amount can be reasonably estimated. When only a range of possible loss can be established, the most probable amount in the range is accrued. If no amount within this range is a better estimate than any other amount within the range, the minimum amount in the range is accrued. The accrual for a litigation loss contingency might include, for example, estimates of potential damages, outside legal fees and other directly related costs expected to be incurred. As of September 30, 2024, and December 31, 2023 the Company was not involved in any material legal proceedings.

Note 7. LEASES

The Company leases its facilities from 1895 Management, Ltd., a New York corporation controlled by an entity affiliated with a director of the Company, under non-cancellable operating leases. The lease agreement requires monthly rental payments of $15,048 through October 31, 2024. The Company entered into a lease extension in September 2024, requiring periodic rental payments, totaling $180,578, through October 2025. The Company is responsible for all maintenance, utilities, insurance, and taxes related to the facility. The Company has elected the practical expedient on not separating lease components from non-lease components.

The Company accounts for its leases under ASC 842, Leases. Leases with an initial term of 12 months or less are not recorded on the condensed balance sheet. The Company determines if an arrangement is a lease at inception. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and lease liabilities are recognized based on the present value of lease payments over the lease term. The leases do not provide an implicit rate so in determining the present value of lease payments, the Company uses its incremental borrowing rate for the applicable lease, which was 7.0%. The Company recognizes lease expense on a straight-line basis over the remaining lease term.

As of September 30, 2024, the future minimum payments for the operating leases total $15,048, less imputed interest of $87, for an operating lease liability of $14,961. For the nine months ended September 30, 2024, and 2023, cash paid for amounts included in the measurement of lease liabilities was $90,290 and $135,434, respectively.

Lease expense incurred under the operating lease for each of the three-month and nine-month periods ended September 30, 2024 and 2023 was $45,144 and, $135,434, respectively. Lease expense is a component of general and administrative expense.

14


 

Note 8. LONG-TERM DEBT

On May 8, 2020, the Company received a loan under the Small Business Administration's Paycheck Protection Program (the "PPP Loan") in the amount of $1,133,600. The PPP Loan originally matured on May 8, 2022, with no principal payments required prior to the maturity date, and bearing interest at an annual rate of 1.0%, with interest payments commencing on November 8, 2020, less the amount of any potential forgiveness. On November 8, 2021, the Company was awarded loan forgiveness of $876,171 and the remaining balance of the loan was refinanced. The loan has a maturity date of May 8, 2025, bears interest of 1%, and is being repaid in monthly payments of $6,334. The Company has recorded interest expense of $141 and $585 for the three-and nine-month periods ended September 30, 2024, respectively, and $336 and $1,141 for the three-and nine-month periods ended September 30, 2023, respectively, on its condensed statements of operations and comprehensive loss.

 

Note 9. CONVERTIBLE PREFERRED STOCK

On March 28, 2024, the Company entered into a securities purchase agreement with the Alzheimer’s Drug Discovery Foundation pursuant to which the Company sold shares of a newly designated series of convertible preferred stock, the Series A Preferred Stock, and warrants to purchase up to 229,057 shares of the Company’s common stock (“ADDF Warrants”) for an aggregate purchase price of $1.75 million. See Note 10, ADDF Warrants. Our Series A Preferred Stock is convertible at the election of the holder at any time after the public announcement by the Company of top-line data from its SIGNAL-AD Alzheimer’s disease study (the “Data Release”) into shares of common stock at a conversion price equal to the greater of (a) $7.77 per share of common stock and (b)(i) the volume weighted average price of the common stock for the last three trading days prior to delivery of the conversion notice if the common stock is traded on a trading market or if its prices are reported on OTCQB or OTCQX, (ii) the most recent bid price of the common stock if it is then traded on The Pink Open Market, or (iii) in all other cases the fair market value of the common stock as determined by an independent appraiser, which conversion right is subject to termination on the last full day preceding the proposed effective date for exercise of the Company’s redemption right or the date fixed for redemption upon a Deemed Liquidation Event (generally defined to include certain fundamental transactions involving the company including a merger or sale of substantially all of the Company’s assets) or on a liquidation, dissolution or winding up of the Company.

The Series A Preferred Stock is non-voting, has no mandatory redemption, and carries an annual 5% cumulative dividend, increasing by 2 percentage points each year, which dividend rate shall not exceed 12%. The Series A Preferred Stock will also participate on an as-converted basis in any regular or special dividends paid to holders of our common stock.

In addition, the Series A Preferred Stock has a liquidation preference equal to the greater of (i) $175,000 per share, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series A Preferred Stock (the “Original Share Price”), plus any accrued but unpaid dividends thereon, whether or not declared, together with any other dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series A Preferred Stock been converted into common stock immediately prior to such liquidation, dissolution, winding up or Deemed Liquidation Event.

The Company also agreed that so long as the Series A Preferred Stock is outstanding, the Company will not, without the written consent of the holders of 50.1% of the Series A Preferred Stock, (i) amend, alter, or repeal any provision of the Company’s certificate of incorporation or bylaws in a manner adverse to the Series A Preferred Stock or (ii) until March 29, 2026, incur any indebtedness for borrowed money in excess of $1.0 million.

The Company has the right to redeem the Series A Preferred Stock at a price equal to the Original Share Price per share at any time after a public announcement of an increase in pepinemab-treated patients relative to placebo-treated patients, with statistical significance having a p-value of less than or equal to 0.05, in the change of the FDG-PET standard uptake value ratio for brain metabolism between baseline and month 12 as assessed by [18F]fluorodeoxyglucose (FDG)-PET in the resting state following administration of 40 mg/kg pepinemab or placebo, as applicable, as described in the protocol for the Company’s SIGNAL-AD Alzheimer’s disease study and the associated Statistical Analysis Plan, provided that (i) the holder is not in possession of any material nonpublic information that was provided by the Company or any of its directors, employees, agents, or affiliates and (ii) there is an effective resale registration statement on file covering the underlying common stock.

15


 

The Series A Preferred Stock have similar characteristics of an “Increasing Rate Security” as described by SEC Staff Accounting Bulletin Topic 5Q, Increasing Rate Preferred Stock. As a result, the discount on Series A Preferred Stock is considered an unstated dividend cost that is amortized over the period preceding commencement of the perpetual dividend using the effective interest method, by charging imputed dividend cost against retained earnings, or additional paid in capital in the absence of retained earnings and increasing the carrying amount of the Series A Preferred Stock by a corresponding amount, to accrete the initial recognized value to its expected settlement value on the expected redemption date. The amortization in each period is the amount which, together with the stated dividend in the period, results in a constant rate of effective cost with regard to the carrying amount of the Series A Preferred Stock.

Each share of Series A Preferred Stock contains redemption features which allow for the redemption of the Series A Preferred Stock in the event of a voluntary or involuntary liquidation, dissolution, winding up of the Company, or Deemed Liquidation Event, as defined in the certificate of designations (“liquidation events”). Upon the occurrence of such qualifying liquidation event, the Series A Preferred Stock holder shall be entitled to receive cash or assets of the Company before any distribution or payment may be made to or set apart for the holders of common stock in an amount per share of Series A Preferred Stock equal to, or greater of, (i) $175,000 plus all accrued and unpaid dividends thereon, whether or not declared (the "Liquidation Preference”); or (2) the amount per share the holder would receive if such holder converted the shares of Series A Preferred Stock immediately prior to the date of such payment, with certain additional conditions.

The embedded redemption features require the Company to settle the Series A Preferred Stock at the Liquidation Preference amount upon the occurrence of certain qualifying liquidation events. The holder’s exercise of the embedded conversion feature when the volume weighted average price of the Common Stock for the last three trading days is greater than $7.77, as defined in the certificate of designations, settles the Series A Preferred Stock through the issuance of a variable number of Common Stock in a fixed monetary amount of $175,000 per share. As these embedded features provide for settlement in nominal amounts not associated with its underlyings, the embedded features each meet the definition of a derivative.

Under ASC 815, certain contractual terms that meet the accounting definition of a derivative must be accounted for separately from the financial instrument in which they are embedded (Note 2). The Company has concluded that the redemption features and the holder’s option to convert when the volume weighted average price of the Common Stock for the last three trading days is greater than $7.77, as defined in the certificate of designations, constitute embedded derivative and, therefore, require bifurcation from the Series A Preferred Stock.

In the event of any liquidation or deemed liquidation event, as defined in the certificate of designations, before any distribution or payment may be made to or set apart for the holders of common stock, the Series A Preferred Stock holder is entitled to receive assets from the Company equal to $175,000 plus all accrued and unpaid dividends thereon, whether or not declared, per share for a total liquidation value of $1.75 million as of September 30, 2024. These redemption provisions were determined to represent embedded derivatives requiring bifurcation from the Series A Preferred Stock.

Upon initial issuance, the Company recorded the fair value of the embedded derivatives in the amount of $95 thousand as a derivative asset and premium on the Series A Preferred Stock. The derivative is adjusted to fair value at each reporting period with the change in the fair value recorded in earnings.

Accordingly, based upon the relative fair values of the instruments on the date of issuance, the Company allocated approximately $0.57 million of the gross proceeds to the ADDF Warrants and $1.18 million of the gross proceeds to the Series A Preferred Stock which is net of $95 thousand, attributed to the derivative asset.

 

Note 10. WARRANTS

Public Warrants

On October 3, 2023, the Company sold in a public offering (i) 542,857 shares of the Company’s common stock together with public warrants to purchase up to 542,857 shares of common stock and (ii) in lieu of shares of common stock, pre-funded warrants exercisable for 142,857 shares of common stock together with public warrants

16


 

to purchase up to 142,857 shares of common stock (the “Offering”). Each public warrant had an initial exercise price equal to $14.00 per share. The public warrants were immediately exercisable and had an expiration date five years from the date of issuance. The shares of common stock and accompanying public warrants were sold at a combined public offering price of $14.00 per share and the accompanying public warrant, and the pre-funded warrants and accompanying public warrants were sold at a combined public offering price of $13.986 per pre-funded warrant and accompanying public warrant, for aggregate gross proceeds of $9.6 million, before deductions for placement agent and offering fees payable by the Company. The public warrants were generally subject to limitations on exercise if the aggregate number of common stock beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation; provided, however, that a holder could increase or decrease the beneficial ownership limitation by giving 61 days’ notice to the Company, but not to any percentage in excess of 9.99%. On July 18, 2024 the 142,857 pre-funded warrants were exercised and converted to common shares.

The Company had the right to “call” any portion of a holder’s public warrants by delivering a call notice to the holder within 30 days after the Company publicly announced an increase in pepinemab-treated patients relative to placebo-treated patients, with statistical significance having a p-value of less than or equal to 0.05, in the change of the FDG-PET standard uptake value ratio for brain metabolism between baseline and month 12 as assessed by [18F]fluorodeoxyglucose (FDG)-PET in the resting state following administration of 40 mg/kg pepinemab or placebo, as applicable, as described in the protocol for the Company’s SIGNAL-AD Alzheimer’s disease study and the associated Statistical Analysis Plan (the “Positive Data Release”). After delivery of a call notice, the public warrants would continue to be exercisable. Each public warrant would be canceled and no longer exercisable to the extent the holder failed to timely exercise the public warrant for the called portion thereof within 20 trading days following the Company’s issuance of a call notice.

In the event of a fundamental transaction, the public warrants required the Company to make a payment based on a Black-Scholes pricing model valuation, using specific inputs that precluded the instruments from being considered indexed to the Company’s own stock in accordance with ASC 815. The public warrants also contained certain terms that provided for an adjustment in response to the occurrence or nonoccurrence of a specified event that is inconsistent with an implicit assumption in a standard valuation model, which also precluded the instruments from being considered indexed to the Company’s stock in accordance with ASC 815. Therefore, upon issuance, the Company accounted for the public warrants as liabilities, which were recorded at the issuance date fair value of approximately $3.5 million.

In March 2024, the Company entered into warrant amendment agreements with holders of approximately 83% of the public warrants issued in the Offering to amend aforementioned terms in the public warrants. The public warrants, as amended, were no longer precluded from being considered indexed to the Company's stock in accordance with ASC 815. As a result, $1.2 million of the public warrant liabilities were reclassified as equity in the Company's condensed statements of stockholders' equity (deficit) for the nine months ended September 30, 2024. In addition, the public warrants, as amended, were marked to fair value on the amendment date resulting in a gain on change in fair value of warrant liabilities of $0.7 million in the Company's condensed statements of operations and comprehensive loss for the nine months ended September 30, 2024.

Private Placement Warrants

In November 2023, pursuant to securities purchase agreements entered into with certain investors, the Company issued and sold private placement warrants to purchase 37,694 shares of common stock. Each private placement warrant had an exercise price which was subject to proportional adjustments in the event of stock splits, combinations (including reverse stock splits), or similar events. The private placement warrants are immediately exercisable and expire five years from the date of issuance and the Company had the right to “call” any portion of the private placement warrants under the same conditions and terms as the public warrants. The private placement warrants were subject to the same beneficial ownership limitations as the public warrants and the pre-funded warrants. Upon issuance, the private placement warrants were precluded from being considered indexed to the Company’s own stock in accordance with ASC 815. Therefore, at issuance, the private placement warrants were liability-classified and recorded at their respective issuance date fair values.

17


 

On February 6, 2024, the Company entered into a securities purchase agreement pursuant to which we issued and sold 274,182 shares of our common stock together with private placement warrants to purchase up to 274,182 shares of common stock and (ii) pre-funded warrants to purchase up to 90,363 shares of common stock together with private placement warrants to purchase up to 90,363 shares of our common stock (the “February 2024 SPA”). Each private placement warrant was immediately exercisable and had an initial exercise price of $14.00 per share. The shares of common stock and accompanying private placement warrants were sold at a combined price of $10.15 per share and the accompanying private placement warrant, and the pre-funded warrants and accompanying private placement warrants were sold at a combined price of $10.1486 per pre-funded warrant and accompanying private placement warrant, for aggregate gross proceeds of approximately $3.7 million.

The Company had the right to “call” the exercise of any portion of a holder’s private placement warrants by delivering a call notice to the holder within 30 days, in the case of the November private placement warrants, or 120 days in the case of the February private placement warrants, after the Positive Data Release. After delivery of a call notice, the private placement warrants will continue to be exercisable. Each private placement warrant would be canceled and no longer exercisable to the extent the holder failed to timely exercise the private placement warrant for the called portion thereof within 20 trading days, in the case of the November private placement warrants, or 30 trading days in the case of the February private placement warrants, following the Company’s issuance of a call notice, provided that to the extent the exercise of a called portion of a private placement warrant would cause the holder to hold common stock in excess of a specified beneficial ownership limitation, upon exercise of such portion, as set forth in the private placement warrant, instead of shares being issued, the exercise would result in the modification of the terms of such portion to be consistent with the terms of the pre-funded warrant. Upon issuance, the private placement warrants were precluded from being considered indexed to the Company’s own stock in accordance with ASC 815. Therefore, at issuance, the private placement warrants were liability-classified and recorded at their issuance date fair value.

In March 2024, the Company entered into warrant amendment agreements with holders of 100% of the private placement warrants issued in November 2023 and holders of 97% of the private placement warrants issued in the February 2024 SPA to amend the aforementioned terms in the private placement warrants. As a result, 354,693 of the November 2023 and February 2024 SPA private placement warrants, as amended, were no longer precluded from being considered indexed to the Company's stock in accordance with ASC 815. The Company reclassified $0.8 million of the amended private placement warrants, as equity, in the Company's condensed statements of stockholders' equity/deficit for the nine months ended September 30, 2024, based on the guidance provided under ASC 815-40. The private placement warrants, as amended, were marked to fair value on the amendment date resulting in a gain on change in fair value of warrant liabilities of $0.36 million in the Company's condensed statements of operations and comprehensive loss for the nine months ended September 30, 2024.

On March 27, 2024, the Company entered into a securities purchase agreement pursuant to which the Company issued and sold 193,000 shares of the Company's common stock in a public offering together with private placement warrants to purchase up to 193,000 shares of common stock in a concurrent private placement at a combined price of $7.77 per share and accompanying private placement warrant for an aggregate purchase price of approximately $1.5 million. The Company had the right to “call” any portion of these private placement warrants under the same conditions and terms as the public warrants and the November private placement warrants. Separately on March 27, 2024, the Company entered into a securities purchase agreement in a different form pursuant to which the Company sold 159,683 shares of common stock and private placement warrants to purchase up to 159,683 shares of common stock in a private placement at a combined price of $7.77 per share and accompanying private placement warrant for an aggregate purchase price of approximately $1.25 million. The Company had the right to “call” any portion of these private placement warrants under the same conditions and terms as the February private placement warrants.

The Company evaluated the March 2024 private placement warrants and concluded that they met the criteria to be classified within stockholders’ equity within additional paid-in-capital. These private placement warrants are equity classified because they (1) are freestanding financial instruments that are legally detachable and separately exercisable from the common stock, (2) are immediately exercisable, (3) do not embody an obligation for the Company to repurchase its shares, (4) permit the holder to receive a fixed number of shares of common stock upon exercise, (5) are indexed to the Company's common stock and (6) meet the equity classification criteria.

18


 

Accordingly, the Company allocated approximately $0.84 million of the proceeds remaining (after the allocation of proceeds to the common stock in the amount equal to their issuance date fair value) to the March private placement warrants on a relative fair value basis for recognition in additional paid-in capital on the date of issuance.

 

Call of Public Warrants and Private Placement Warrants

In August 2024, the Company called for cancellation the public warrants and the private placement warrants, pursuant to terms of the warrants permitting the Company to call the warrants for cancellation following the announcement of a statistically significant increase in FDG-PET signal in patients in the Company’s SIGNAL-AD trial of pepinemab for the treatment of Alzheimer’s disease. All of the public warrants and private placement warrants not exercised pursuant to the Inducement Letter Agreements were thereafter canceled in September 2024. As of September 30, 2024, none of the private placement warrants or the public warrants were outstanding.

Inducement Transaction

On September 17, 2024, the Company entered into inducement letter agreements (the “Inducement Letter Agreements”) with holders (the “Holders”) of existing warrants to purchase up to an aggregate of 1,067,492 shares of the Company’s common stock, par value $0.0001 per share, originally issued to the Holders between October 2023 and March 2024 as public warrants or private placement warrants (the “Existing Warrants”). Pursuant to the Inducement Letter Agreements, the Holders agreed to exercise for cash the Existing Warrants at a reduced exercise price of $5.636 per share in consideration of the Company’s agreement to issue new unregistered common warrants (the “New Warrants”) to purchase up to 1,601,238 shares of common stock (the “New Warrant Shares”), which were issued and sold in a private placement at a price of $0.125 per New Warrant. Each New Warrant had an initial exercise price equal to $5.636 per share, was immediately exercisable, and expires September 18, 2029. Included in the exercise of the Existing Warrants were the public warrants issued in the Offering and the private placement warrants issued in the February 2024 SPA, which had not been reclassified to equity in March 2024. The Company revalued the Offering public warrants and the February 2024 SPA liability classified private placement warrants on September 17, 2024, resulting in a fair value of $0.2 million. The decrease in the fair value of the common stock warrant liability throughout the year resulted in an offsetting gain on common stock warrant liabilities in the Statements of Operations.

The exercise of the Existing Warrants resulted in the Company issuing 872,028 shares of common stock and, pursuant to terms of the Existing Warrants, the pre-funding of 195,464 shares of common stock underlying Existing Warrants where the applicable Holder would have exceeded a specified beneficial ownership limitation contained in the applicable Existing Warrant if shares of common stock had been issued.

The gross proceeds to the Company from the exercise of the Existing Warrants and the sale of the New Warrants are approximately $6.2 million, prior to deducting financial advisory fees and estimated transaction expenses. The closing of the transactions contemplated by the Inducement Letter Agreements occurred in part on September 18, 2024 and in part on September 19, 2024.

ADDF Warrants

In connection with the securities purchase agreement with the Alzheimer’s Drug Discovery Foundation, the Company sold ADDF Warrants to purchase up to 229,057 shares of common stock. Each ADDF Warrant has an initial exercise price equal to $7.64 per share, subject to proportional adjustments in the event of stock splits, combinations (including reverse stock splits), or similar events. These ADDF Warrants are immediately exercisable and will expire on March 29, 2029.

The Company evaluated the ADDF Warrants and concluded they met the criteria to be classified within stockholders’ equity within additional paid-in-capital. The ADDF Warrants are equity classified because they (1) are freestanding financial instruments that are legally detachable and separately exercisable from the common stock, (2)

19


 

are immediately exercisable, (3) do not embody an obligation for the Company to repurchase its shares, (4) permit the holder to receive a fixed number of shares of common stock upon exercise, (5) are indexed to the Company's common stock and (6) meet the equity classification criteria.

As of September 30, 2024, all of the ADDF warrants were outstanding.

Pre-Funded Warrants

In connection with the exercise of Existing Warrants in the September 2024 inducement transaction, the Company pre-funded 195,464 shares of common stock underlying Existing Warrants where the applicable Holder would have exceeded a specified beneficial ownership limitation contained in the applicable Existing Warrants if shares of common stock had been issued.

In connection with the February 2024 SPA, the Company sold pre-funded warrants exercisable for 90,363 shares of common stock. Each pre-funded warrant has an initial exercise price equal to $0.0014 per share, subject to proportional adjustments in the event of stock splits, combinations (including reverse stock splits), or similar events. The pre-funded warrants may be exercised at any time and will not expire until exercised in full. The pre-funded warrants are subject to the same beneficial owner limitations as the private placement warrants.

The Company evaluated the pre-funded warrants and concluded that they met the criteria to be classified within stockholders’ equity within additional paid-in-capital. The pre-funded warrants are equity classified because they (1) are freestanding financial instruments that are legally detachable and separately exercisable from the common stock, (2) are immediately exercisable, (3) do not embody an obligation for the Company to repurchase its shares, (4) permit the holder to receive a fixed number of shares of common stock upon exercise, (5) are indexed to the Company's common stock and (6) meet the equity classification criteria.

Accordingly, the Company allocated approximately $0.9 million of the proceeds remaining (after the allocation of proceeds to the liability-classified private placement warrants in the amount equal to their issuance date fair value) to the pre-funded warrants on a relative fair value basis for recognition in additional paid-in capital on the date of issuance.

As of September 30, 2024, all of the February 2024 SPA pre-funded warrants and pre-funded shares in connection with the September 2024 inducement transaction were outstanding.

Note 11. COMMON STOCK RESERVED FOR ISSUANCE

Common stock has been reserved for the following potential future issuance:

 

 

 

As of
September 30, 2024

 

 

As of
December 31, 2023

 

Shares underlying outstanding stock options

 

 

84,358

 

 

 

14,323

 

Shares available for future stock option grants

 

 

3,318

 

 

 

528

 

Shares underlying outstanding public warrants

 

 

-

 

 

 

685,714

 

Shares underlying outstanding private placement warrants

 

 

1,830,297

 

 

 

37,694

 

Shares underlying convertible preferred stock-if converted

 

 

225,225

 

 

 

-

 

Shares underlying outstanding pre-funded warrants

 

 

285,827

 

 

 

142,857

 

Total shares of common stock reserved

 

 

2,429,025

 

 

 

881,116

 

 

20


 

Note 12. STOCK-BASED COMPENSATION

2011 Employee Equity Plan

In connection with the adoption of the Company’s 2018 Omnibus Incentive Plan in August 2018, the Company ceased granting stock options under the Company’s 2011 Employee Equity Plan (the “2011 Plan”). However, the 2011 Plan will continue to govern the terms and conditions of the outstanding stock options previously granted thereunder. Any shares of stock related to awards outstanding under the 2011 Plan that terminate by expiration, forfeiture, cancellation, or otherwise without the issuance of such shares will become available for grant under the 2018 Omnibus Incentive Plan. Stock options granted under the 2011 Plan expire in five or ten years from the date of grant.

2018 Omnibus Incentive Plan

In August 2018, the Company’s board of directors adopted, and its stockholders approved, the 2018 Omnibus Incentive Plan, which allows for the granting of restricted stock, stock options, and stock appreciation rights awards to employees, advisors, and consultants.

On June 22, 2018, the Company’s Board of Directors adopted the First Amendment to the 2018 Omnibus Incentive Plan, subject to stockholder approval, to (i) add a one-time automatic increase in the shares of common stock issuable under the 2018 Plan, (ii) increase the percentage by which the shares of common stock issuable under the 2018 Plan automatically increase each year, and (iii) extend the term of the 2018 Plan to March 21, 2034. On May 9, 2024, the Company’s stockholders approved the First Amendment to the 2018 Omnibus Incentive Plan.

Stock options granted under the 2018 Omnibus Incentive Plan, as amended (the “2018 Plan”) may be either incentive stock options or non-statutory stock options. Incentive stock options may be granted to employees, advisors, and consultants at exercise prices of no less than the fair value of the common stock on the grant date. If at the time of grant, the optionee owns stock representing more than 10% of the voting power of all classes of stock of the Company, the exercise price must be at least 110% of the fair value of the common stock on the grant date as determined by the board of directors. Non-statutory stock options may be granted to employees, advisors and consultants at exercise prices of less than the fair market value of a share of common stock on the date the non-statutory stock option is granted but shall under no circumstances be less than adequate consideration as determined by the board of directors for such a share. The vesting period of stock option grants is determined by the board of directors, ranging from zero to eight years. Stock options granted under the 2018 Plan expire in five or ten years from the date of grant.

The Company initially reserved 2,024 shares of common stock for issuance, subject to certain adjustments, pursuant to awards under the 2018 Plan. Any shares of common stock related to awards outstanding under the 2011 Plan as of the effective date of the 2018 Plan, which thereafter terminate by expiration, forfeiture, cancellation or otherwise without the issuance of such shares, will be added to, and included in, the number of shares of common stock available for grant under the 2018 Plan. In addition, (i) on May 9, 2024, the number of shares of common stock reserved for issuance under the 2018 Plan automatically increased by 55,422 shares, which represented 4.5% of the total number of shares of common stock outstanding on March 22, 2024, and (ii) on each January 1st effective January 1, 2020 through January 1, 2024 and from January 1, 2025 and continuing until the expiration of the 2018 Plan, the number of shares of common stock available for issuance under the 2018 Plan will automatically increase annually by 2% and 3%, respectively, of the total number of issued and outstanding shares of the Company’s common stock as of December 31 of the preceding year or such lesser number as the Company’s board of directors may decide, which may be zero. Accordingly, on January 1, 2024, 17,849 additional shares of common stock became available for issuance under the 2018 Plan.

21


 

A summary of the Company’s stock option activity and related information is as follows:

 

 

 

Stock
Options

 

 

Weighted-
Average
Exercise
Price

 

 

Weighted-
Average
Remaining
Contractual
Life (Years)

 

 

Aggregate
Intrinsic
Value (in thousands)

 

Balance as of January 1, 2024

 

 

14,323

 

 

$

446.93

 

 

 

7.7

 

 

$

-

 

Granted

 

 

73,906

 

 

 

5.75

 

 

 

9.6

 

 

 

 

Exercised

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Forfeited

 

 

(3,847

)

 

 

212.95

 

 

 

 

 

 

 

Expired

 

 

(24

)

 

 

3,129.00

 

 

 

 

 

 

 

Balance as of September 30, 2024

 

 

84,358

 

 

$

70.51

 

 

 

9.2

 

 

$

-

 

Exercisable as of September 30, 2024

 

 

15,773

 

 

$

329.72

 

 

 

7.7

 

 

$

-

 

 

The weighted-average grant date fair value of stock options granted to employees and directors for the nine months ended September 30, 2024, and 2023 was $3.79 per share and $4.15 per share, respectively. The aggregate grant date fair value of stock options that vested during the nine months ended September 30, 2024, and 2023 was $452,234 and $513,718, respectively.

The intrinsic value of stock options vested and exercisable and expected to vest and become exercisable is calculated based on the difference between the exercise price and the fair value of the Company’s common stock as of September 30, 2024, and December 31, 2023. The intrinsic value of exercised stock options is the difference between the fair value of the underlying common stock and the exercise price as of the exercise date.

As of September 30, 2024, and December 31, 2023, total unrecognized compensation cost related to stock options granted to employees was $342,729 and $448,511, respectively, which is expected to be recognized over a weighted-average period of 1.54 and 2.16 years, respectively.

The grant date fair value of employee stock options was estimated using a Black-Scholes option-pricing model with the following weighted-average assumptions:

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

Expected term (in years)

 

 

6.0

 

 

 

6.0

 

Expected volatility

 

 

75

%

 

 

75

%

Risk-free interest rate

 

 

4.5

%

 

 

3.7

%

Expected dividend yield

 

 

-

%

 

 

-

%

 

 

Total stock-based compensation expense recognized in the condensed statements of operations and comprehensive loss is as follows (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Research and development

 

$

22

 

 

$

48

 

 

$

99

 

 

$

148

 

General and administrative

 

 

54

 

 

 

67

 

 

 

185

 

 

 

222

 

Total stock-based compensation expense

 

$

76

 

 

$

115

 

 

$

284

 

 

$

370

 

 

Note 13. INCOME TAXES

No provision for income taxes was recorded in either of the three-or nine-month periods ended September 30, 2024, and 2023. The Company remains in a cumulative loss position with a full valuation allowance recorded against its net deferred income tax assets as of September 30, 2024.

22


 

The Company evaluates tax positions for recognition using a more-likely-than-not recognition threshold, and those tax positions eligible for recognition are measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon the effective settlement with a taxing authority that has full knowledge of all relevant information. As of September 30, 2024, and December 31, 2023, the Company had no unrecognized income tax benefits that would affect the Company’s effective tax rate if recognized.

 

Note 14. NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS

 

The following weighted-average common stock equivalents were excluded from the calculation of diluted net loss per share for the periods presented as they had an anti-dilutive effect:

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

 

 

 

 

 

 

 

 

Options to purchase common stock

 

 

86,413

 

 

 

14,499

 

 

 

54,041

 

 

 

11,835

 

Public warrants to purchase common stock

 

 

551,553

 

 

 

-

 

 

 

640,994

 

 

 

-

 

If-converted common shares from convertible preferred stock

 

 

225,225

 

 

 

-

 

 

 

153,450

 

 

 

-

 

Private placement warrants to purchase common stock

 

 

1,149,565

 

 

 

-

 

 

 

803,043

 

 

 

-

 

 

Note 15. SEGMENT AND GEOGRAPHIC INFORMATION

 

The Company’s chief operating decision maker, its Chief Executive Officer, reviews its operating results on an aggregate basis for purposes of allocating resources and evaluating financial performance. The Company has one business activity, the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, and there are no segment managers who are held accountable for operations or operating results. Accordingly, the Company operates in one reportable segment. As of September 30, 2024, and December 31, 2023, all long-lived assets are located in the United States.

Note 16. RELATED PARTY TRANSACTIONS

As discussed in Note 7, the Company leases its facility from 1895 Management, Ltd., a New York corporation controlled by an entity affiliated with the Company’s chairman and major stockholder of the Company. Lease expense incurred under the operating lease for each of the three-month and nine-month periods ended September 30, 2024 and 2023 was $45,144 and, $135,434, respectively.

 

On March 30, 2023, the Company entered into a Stock Purchase Agreement, pursuant to which the Company issued and sold 23,693 shares of its common stock at a purchase price of $86.10 per share for aggregate gross proceeds of $2.04 million (the "March 2023 Private Placement”). FCMI Parent Co. (“FCMI”), which is controlled by Albert D. Friedberg, the chairman of the Company’s board of directors, and Vaccinex (Rochester) L.L.C., which is majority owned and controlled by Dr. Maurice Zauderer, the Company’s President, Chief Executive Officer, and a member of the Company’s board of directors, purchased 23,229 shares of the Company's common stock for an aggregate purchase price of $2.0 million in the March 2023 Private Placement. In addition, FCMI made a binding commitment in the Stock Purchase Agreement to purchase, on or prior to May 15, 2023, up to an additional $2.96 million of shares of the Company's common stock, less the aggregate purchase price of securities of the Company other than the shares sold by the Company to investors other than FCMI and its affiliates after the closing and on or prior to May 15, 2023, and subject to the terms and conditions of the Stock Purchase Agreement.

 

On February 6, 2024, the Company entered into a securities purchase agreement pursuant to which it issued and sold 274,182 shares of our common stock together with private placement warrants to purchase up to 274,182 shares of common stock and (ii) pre-funded warrants to purchase up to 90,363 shares of common stock together with private placement warrants to purchase up to 90,363 shares of our common stock (the “February 2024 SPA”). The shares of common stock and accompanying private placement warrants were sold at a combined price of $10.15 per share and the accompanying private placement warrant, and the pre-funded warrants and accompanying private placement warrants were sold at a combined price of $10.1486 per pre-funded warrant and accompanying private

23


 

placement warrant, for aggregate gross proceeds of approximately $3.7 million. FCMI and Vaccinex (Rochester), L.L.C. purchased shares of the Company’s common stock and accompanying warrants in this transaction.

On March 27, 2024, the Company entered into a securities purchase agreement in a different form pursuant to which the Company sold 159,683 shares of common stock and warrants to purchase up to 159,683 shares of common stock in a private placement at a combined price of $7.77 per share and accompanying warrant for an aggregate purchase price of approximately $1.25 million. FCMI and Vaccinex (Rochester), L.L.C. purchased shares of the Company's common stock and accompanying warrants in this transaction. This transaction closed on March 28, 2024.

On September 17, 2024, the Company entered into the Inducement Letter Agreements as described in Note 10 above. FCMI and Vaccinex (Rochester), L.L.C. participated in the transactions contemplated by the Inducement Letter Agreements.

 

Note 17. SUBSEQUENT EVENTS

On November 13, 2024, the Company entered into a securities purchase agreement pursuant to which the Company issued and sold to the purchasers named therein (the “Investors”) an aggregate of (i) 76,909 shares (“Shares”) of the Company’s common stock (“Common Stock”) at a price of $3.25 per Share and (ii) pre-funded warrants (“Pre-Funded Warrants”) to purchase up to 584,646 shares of Common Stock at a price of $3.2499 per Pre-Funded Warrant (such transaction, the “Private Placement”). The Private Placement closed on November 14, 2024 for aggregate gross proceeds to the Company of approximately $2.15 million.

The Pre-Funded Warrants have an initial exercise price of $0.0001 per share, are immediately exercisable, and may be exercised at any time until they are exercised in full, subject to a 39.99% beneficial ownership limitation provision contained therein. The Investors are FCMI Parent Co., which purchased Shares and Pre-Funded Warrants and is controlled by Albert D. Friedberg, chair of the Company’s board of directors, and Vaccinex (Rochester), L.L.C., which purchased Shares and is controlled by Maurice Zauderer, Ph.D., the Company’s president, chief executive officer and a member of the Company’s board of directors.

24


 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

References in this Quarterly Report on Form 10-Q, or this Report, to the “Company,” “we,” “our,” or “us” mean Vaccinex, Inc. and its subsidiaries except where the context otherwise requires You should read the following discussion and analysis of financial condition and results of operations together with our condensed financial statements and related notes included elsewhere in this Report, as well as the audited financial statements, related notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations and other disclosures included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, or the Annual Report.

Cautionary Note Regarding Forward-Looking Statements

The following discussion and other parts of this Report contain forward-looking statements that involve risk and uncertainties, such as statements of our plans, objectives, expectations, and intentions. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “expects,” “plans,” “anticipate,” “believes,” “estimates,” “potential,” or “continue,” or the negative of these terms or other comparable terminology. Forward-looking statements include, but are not limited to, statements about:

our ability to continue as a going concern;
our ability to regain compliance with the Nasdaq listing requirements;
the sufficiency of the financing arrangements we have entered into, that are intended to fund our payroll and certain other operations for a limited period of time, and our ability to service our outstanding debt obligations;
our estimates regarding our expenses, future revenues, anticipated capital requirements and our needs for additional financing;
the implementation of our business model and strategic plans for our business and technology;
the timing and success of the commencement, progress, and receipt of data from any of our preclinical and clinical trials;
our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates;
the expected results of any clinical trial and the impact on the likelihood or timing of any regulatory approval;
the difficulties in obtaining and maintaining regulatory approval of our product candidates;
the rate and degree of market acceptance of any of our product candidates;
the success of competing therapies and products that are or become available;
regulatory developments in the United States and foreign countries;
current and future legislation regarding the healthcare system;
the scope of protection we establish and maintain for intellectual property rights covering our technology;
developments relating to our competitors and our industry;
our failure to recruit or retain key scientific or management personnel or to retain our executive officers;
the performance of third parties, including collaborators, contract research organizations and third-party manufacturers;
the development of our commercialization capabilities, including the need to develop or obtain additional capabilities; and
our use of the proceeds from the offerings of our common stock.

25


 

Although we believe that the expectations reflected in the forward-looking statements contained herein are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the risk factors identified in the “Risk Factors” section of this Report, and in Part I, Item 1A of the Annual Report on Form 10-K, as well as in our other filings with the Securities and Exchange Commission, or SEC. The forward-looking statements speak only as of the date they were made. Except as required by law, after the date of this Report, we are under no duty to update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise. We qualify all of our forward-looking statements by the foregoing cautionary statements.

Common Stock Reverse Splits

On September 25, 2023, the Company effected a 1-for-15 reverse stock split of its issued shares of common stock. On February 19, 2024, the Company effected a second reverse split of shares of the Company's common stock on a 1-for-14 basis. All per share amounts, common shares outstanding, warrants, and stock-based compensation amounts for all periods presented have been retroactively adjusted to reflect these reverse stock splits. The shares of common stock retain a par value of $0.0001 per share.

Company Overview

We are a clinical-stage biotechnology company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, including neurodegenerative diseases, cancer, and autoimmune disorders. We believe we are the leader in the field of semaphorin 4D, or SEMA4D, biology and that we are the only company targeting SEMA4D as a potential treatment for neurodegenerative diseases, cancer, and autoimmune disorders. SEMA4D is an extracellular signaling molecule that regulates the activity of immune and inflammatory cells at sites of injury, cancer, or infection. We are leveraging our SEMA4D antibody platform and our extensive knowledge of SEMA4D biology to develop our lead product candidate, pepinemab, an antibody that we believe utilizes novel mechanisms of action. We are focused on developing pepinemab for the treatment of Alzheimer’s disease, Huntington’s disease, head and neck cancer, and pancreatic cancer. Additionally, third party investigators are studying pepinemab in clinical trials in breast cancer, as well as in “window of opportunity” studies in other indications, including head and neck cancer, and melanoma. We have developed multiple proprietary platform technologies and are developing product candidates to address serious diseases or conditions that have a substantial impact on day-to-day functioning and for which treatment is not addressed adequately by available therapies. We employ our proprietary platform technologies, including through our work with our academic collaborators, to identify potential product candidates for sustained expansion of our internal product pipeline and to facilitate strategic development and commercial partnerships.

Our lead platform technologies include our SEMA4D antibody platform and our ActivMAb antibody discovery platform. Our lead product candidate, pepinemab, is currently in clinical development for the treatment of Alzheimer’s disease, head and neck, pancreatic and breast cancer, through our efforts or through investigator-sponsored trials. Our additional product candidates, VX5 (CXCL13 Mab) and CXCR5 Mab are in earlier stages of development and were selected using our ActivMAb platform. We believe our multiple platform technologies position us well for continued pipeline expansion and partnership opportunities going forward.

We have generated a limited amount of service revenue from collaboration agreements but have not generated any revenue from sales of our product candidates to date. We continue to incur significant development and other expenses related to our ongoing operations. As a result, we are not and have never been profitable and have incurred losses in each period since our inception, resulting in substantial doubt in our ability to continue as a going concern. We reported a net loss of $5.7 million and $4.9 million for the three months ended September 30, 2024 and 2023, respectively, and a net loss of $15.3 million and $16.9 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, and December 31, 2023, we had cash and cash equivalents of $2.9 million and $1.5 million, respectively. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, our product candidates. We may also encounter unforeseen expenses, difficulties, complications,

26


 

delays, and other unknown factors which may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues, if any.

Our recurring net losses and negative cash flows from operations raised substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our condensed financial statements for the three and nine months ended September 30, 2024. Until we can generate sufficient revenue from the commercialization of our product candidates, we expect to finance our operations through the public or private sale of equity, debt financing or other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. To date, we have relied on equity and debt financing to fund its operations, in addition to capital contributions from noncontrolling interests and a limited amount of service revenue from collaboration agreements.

In August 2024, we called for cancellation the public warrants and the private placement warrants pursuant to terms of the warrants permitting us to call the warrants for cancellation following the announcement of a statistically significant increase in FDG-PET signal in patients in our SIGNAL-AD trial of pepinemab for the treatment of Alzheimer’s disease. All of the public warrants and private placement warrants not exercised pursuant to the Inducement Letter Agreements were thereafter canceled in September 2024. As of September 30, 2024, none of the private placement warrants or the public warrants were outstanding. A holder of certain of the warrants that we called for cancellation has notified us that it believes that the warrants it held are still outstanding. The number of shares represented by these canceled warrants represents approximately 8% of our outstanding shares as of September 30, 2024, on a pre-issuance basis. Should this misunderstanding continue and a resolution be required and reached, there could be adverse impacts to the Company, including the payment of damages or the issuance of additional shares of common stock.

On September 17, 2024, we entered into the Inducement Letter Agreements with the Holders of the Existing Warrants. Pursuant to the Inducement Letter Agreements, the Holders agreed to exercise for cash the Existing Warrants at a reduced exercise price of $5.636 per share in consideration of our agreement to issue the New Warrants to purchase up to 1,601,238 shares of common stock, which were issued and sold in a private placement at a price of $0.125 per New Warrant. Each New Warrant had an initial exercise price equal to $5.636 per share, was immediately exercisable, and expires September 18, 2029. The gross proceeds to us from the exercise of the Existing Warrants and the sale of the New Warrants were approximately $6.2 million, prior to deducting financial advisory fees and estimated transaction expenses. FCMI Parent Co. (“FCMI”), which is controlled by Albert D. Friedberg, the chairman of our board of directors, and Vaccinex (Rochester) L.L.C., which is majority owned and controlled by Dr. Maurice Zauderer, our President, Chief Executive Officer, and a member of our board of directors, participated in the transactions contemplated by the Inducement Letter Agreements.

On March 28, 2024, we entered into a securities purchase agreement with Alzheimer’s Drug Discovery Foundation pursuant to which we sold shares of a newly designated series of convertible preferred stock, our Series A Preferred Stock, and warrants to purchase up to 229,057 shares of our common stock for an aggregate purchase price of $1.75 million.

On March 27, 2024, we entered into a securities purchase agreement pursuant to which we issued and sold 193,000 shares of our common stock in a public offering together with warrants to purchase up to 193,000 shares of common stock in a concurrent private placement at a combined price of $7.77 per share and accompanying warrant for an aggregate purchase price of approximately $1.5 million. Separately on March 27, 2024, we entered into a securities purchase agreement in a different form pursuant to which we sold 159,683 shares of common stock and warrants to purchase up to 159,683 shares of common stock in a private placement at a combined price of $7.77 per share and accompanying warrant for an aggregate purchase price of approximately $1.25 million. FCMI and Vaccinex (Rochester) L.L.C. purchased shares of our common stock and accompanying warrants in the latter transaction.

On February 6, 2024, we entered into a securities purchase agreement pursuant to which we issued and sold 274,182 shares of our common stock together with warrants to purchase up to 274,182 shares of common stock at a combined price of $10.15 per share and accompanying warrant and (ii) pre-funded warrants to purchase up to 90,363 shares of common stock together with warrants to purchase up to 90,363 shares of our common stock at a combined price of $10.1486 per pre-funded warrant and accompanying warrant, for aggregate gross proceeds of

27


 

approximately $3.7 million. FCMI and Vaccinex (Rochester) L.L.C. purchased 118,227 and 29,557 shares of our common stock and accompanying warrants, respectively, in the February 2024 offering for an aggregate purchase price of $1.5 million.

 

Our cash and cash equivalents were $2.9 million and total current assets were $4.8 million at September 30, 2024, which will be insufficient to fund our planned operations through one year of the date that these condensed financial statements are available for issuance. See Note 1 of our unaudited condensed financial statements. There can be no assurances that we will be able to secure additional financing when needed, or if available, that it will be sufficient to meet our needs or on favorable terms.

Nasdaq Deficiency Notice

On April 11, 2024, the Company received a letter from the Listing Qualifications staff of Nasdaq notifying the Company that based on the financial statements contained in its Form 10-K for the year-ended December 31, 2023, it no longer complies with the requirement under Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders’ equity for continued listing on the Nasdaq Capital Market (the “Equity Standard”) or the alternative requirements of having a market value of listed securities of $35.0 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years (the “Alternative Standards”) , and may be subject to delisting. The notification letter had no immediate effect on the Company’s listing on the Nasdaq Capital Market and the Company timely submitted a plan to regain compliance with the Equity Standard.

On June 5, 2024, Nasdaq notified the Company that it has been provided an extension to regain and evidence compliance with the Equity Standard on or before September 30, 2024. As of September 30, 2024, we had a stockholders' deficit of $1.3 million. On October 7, 2024, the Company received a letter from the Nasdaq Listing Staff stating that the Company had not regained compliance with the Equity Standard or the Alternatives Standards and that, as a result, unless the Company timely requested an appeal of this determination to a Nasdaq Hearings Panel, Nasdaq would move to suspend trading of the Company’s common stock and to have the Company’s securities delisted from the Nasdaq Capital Market. The Company timely appealed the determination, which automatically stayed any suspension or delisting action pending the Hearings Panel’s decision and the expiration of any additional extension period granted by the Hearings Panel following the hearing set for December 5, 2024. As a result, the Company’s common stock is expected to remain listed on the Nasdaq Capital Market through at least that time. However, there can be no assurance that the Hearings Panel will grant the Company’s request for continued listing or that the Company will be able to demonstrate compliance with the Equity Standard or the Alternative Standards within any additional compliance period that may be granted by the Hearings Panel.

Clinical Update

Alzheimer's Disease

The Company initiated a randomized, placebo-controlled, multi-center phase 1/2a clinical study of pepinemab in AD, or the SIGNAL-AD trial, in 2021. On March 28, 2024, we entered into a second agreement with Alzheimer’s Drug Discovery Foundation pursuant to which we sold shares of a newly designated series of convertible preferred stock, our Series A Preferred Stock, and warrants to purchase up to 229,057 shares of our common stock for an aggregate purchase price of $1.75 million. This trial is based on evidence from the SIGNAL clinical trial in HD that showed treatment with pepinemab reduced cognitive decline and induced a sharp increase in glucose metabolism in the brain during HD disease progression as detected by conventional FDG-PET imaging. Previous studies in AD have shown that decline in glucose metabolism correlates with cognitive decline. In April 2023, we reached our enrollment target for the Phase 1b/2 SIGNAL-AD study evaluating pepinemab as a potential treatment for people with Mild Cognitive Impairment (MCI) or mild dementia due to AD. On April 25, the Company provided an update regarding plans for analysis of biomarkers and clinical outcome measures during a presentation at 12th Annual Alzheimer’s & Parkinson’s Drug Development Summit. All 50 participants have completed 12-months of treatment on June 30, 2024, and SIGNAL-AD topline data was reported by Eric Siemers, MD, Principal Investigator of the SIGNAL-AD trial at the Alzheimer's Association International Conference in Philadelphia on July 31, 2024. Additional efficacy data for SIGNAL-AD was reported by Elizabeth Evans, PhD, Senior VP Discovery and

28


 

Translational Research and Chief Operating Officer on October 31, 2024, at the Clinical Trials on Alzheimer’s Disease Conference in Madrid, Spain.

An important secondary endpoint of the study was to determine whether pepinemab prevents decline in brain metabolic activity consistent with blocking astrocyte reactivity as evidenced by an increase in FDG-PET imaging signal in a major brain region known to be affected by disease progression. This was determined over the course of 12-months of treatment with pepinemab relative to placebo. Pepinemab treatment resulted in a statistically significant increase (p=0.0297) in FDG-PET signal in the medial temporal cortex of patients with Mild Cognitive Impairment (MCI) due to AD. The medial temporal region of brain includes hippocampus and entorhinal cortex, known to be affected during early disease progression in many patients with MCI. A similar significant result of pepinemab treatment on brain metabolic activity was previously shown in our phase 2 study of HD, which we believe highlights mechanistic similarities in the pathology of these two neurodegenerative diseases.

Although the present study was not sufficiently powered to detect cognitive effects or changes in some additional secondary endpoints with statistical significance, we previously reported that, in a larger study that enrolled approximately 90 HD patients/arm with early symptoms of cognitive deficits, seemingly similar to MCI in AD, pepinemab treatment improved performance on key cognitive and psychological measures.

We believe that results of the SIGNAL-AD study demonstrate that pepinemab has a similar effect in Alzheimer’s to those we previously described for a key outcome in Huntington’s disease, preventing the characteristic disease-related decline of brain metabolic activity in a brain region known to be affected early in disease progression. This positive data release suggests that pepinemab has the potential to benefit patients with MCI due to AD. AD and HD share important pathological features and clinical symptoms, and we believe that our approach of confirming similar treatment effects of pepinemab in these two different neurodegenerative diseases is strongly supportive of pepinemab as a potentially well-tolerated and effective treatment for both Alzheimer’s and Huntington’s disease.

Our study indicates that pepinemab may be most effective in patients with early stage symptoms, e.g., Mild Cognitive Impairment (MCI) or Mild Dementia due to AD. This suggests that a promising treatment strategy would be to identify people with MCI as early as possible and to treat with pepinemab to keep them from progressing for as long as possible. We believe that, to date, no disease modifying therapy has been shown to be effective in later stages of AD dementia.

The Alzheimer’s Association estimates that 12% to 18% of people age 60 or older are living with MCI due to AD and that about one-third of these patients will develop dementia within five years. A drug that can slow progression of MCI could significantly extend a rewarding and productive life for people at risk.

Pepinemab has been well-tolerated in clinical trials that enrolled a total of more than 600 patients primarily in neurological indications, AD, HD, and MS. Current concerns about the limitations of treatment with approved anti-Aβ amyloid antibodies such as Leqembi™ (Eisai and Biogen) and Kisunla™ (Eli Lilly) might make pepinemab, if approved, attractive as either an alternative for patients at high risk for adverse events related to treatment with Leqembi or Kisunla, and could also be a complementary treatment to enhance benefit of such anti-Aβ antibodies to patients.

Cancer

As prespecified in the study protocol, the Company analyzed interim data from the first 36 patients in the open-label, single-arm, Phase 2 KEYNOTE B-84 study (NCT04815720) evaluating pepinemab and KEYTRUDA™ in immunotherapy naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The study was based on preclinical and clinical studies demonstrating that antibody blockade of semaphorin 4D (SEMA4D) in combination with immune checkpoint inhibitors (ICI) promotes infiltration of CD8+ cytotoxic T cells and inhibits the recruitment and function of myeloid derived suppressor cells (MDSC) in tumors, enabling enhanced ICI efficacy. The study results showed that pepinemab in combination with KEYTRUDA™ resulted in an approximately 2X increase in objective responses (ORR) and median progression free survival (PFS) in patients with hard-to-treat PD-L1-low tumors, those with combined positive score <20 (CPS<20), compared to historical response rates for ICI monotherapy in this population. ORR for the CPS<20 population was 21.1% with median PFS

29


 

of 5.79 months, which is almost 2X that of historical response to checkpoint monotherapy in this population, ORR 11.9% and PFS 2.2 months. In contrast, patients in the CPS>20 subgroup (n=17) responded similarly to historical ICI monotherapy data. Biopsy data suggest that treatment-induced formation of highly organized lymphoid aggregates, tertiary lymphoid structures (TLS), correlate with disease control. TLS are characterized by a high density of B cells, antigen-presenting dendritic cells and activated T cells including stem-like TCF-1+, PD-1+, CD8+ T cells whose expansion and differentiation has previously been shown to be central for response to checkpoint inhibitors. The safety of pepinemab in combination with KEYTRUDA is regularly reviewed by an independent safety committee and has to date been found to be well tolerated.

 

In January and March 2024, the Company and its collaborators presented posters at the ASCO Gastrointestinal Cancers Symposium and the Society for Surgical Oncology Annual Meeting, respectively:

Phase 1b/2 PDAC Study: The team from University of Rochester Cancer Center and Wilmot Cancer Institute presented the plan for the single-arm, open-label study to evaluate pepinemab in combination with BAVENCIO®(avelumab) as second line combination immunotherapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC, TPS4195, NCT05102721). The Company-sponsored study will employ a Bayesian Optimal Interval (BOIN) Design in the Phase 1b segment and a Simon two stage assessment in the Phase 2 segment and is expected to enroll 40 subjects. The trial rationale is supported by data from prior studies suggesting that pepinemab may reduce immune suppression in the TME, rendering “cold” tumors such as PDAC to become “hot” and enhancing efficacy of ICIs such as avelumab. The study is being conducted with grant support from the Gateway Discovery Award.

 

Financial Overview

Revenue

To date, we have not generated any revenue from sales of our product candidates. The Company recorded service revenue of $52,000 and $20,000 during the three months ended September 30, 2024 and 2023, respectively. The Company recorded service revenue of $388,000 and $70,000 during the nine months ended September 30, 2024 and 2023, respectively, and $500,000 in revenue related to the achievement of a contractual milestone during the nine months ended September 30, 2023 from our collaboration agreement with Surface Oncology.

 

Our ability to generate revenue and become profitable depends on our ability to successfully obtain marketing approval of and commercialize our product candidates. We do not expect to generate product revenue in the foreseeable future as we continue our development of, and seek regulatory approvals for, our product candidates, and potentially commercialize approved products, if any.

Operating Expenses

Research and Development. Research and development expenses consist primarily of costs for our clinical trials and activities related to regulatory filings, employee compensation-related costs, supply expenses, equipment depreciation and amortization, consulting, and other miscellaneous costs. The following table sets forth the components of our research and development expenses and the amount as a percentage of total research and development expenses for the periods indicated.

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

 

%

 

 

(in thousands)

 

 

%

 

 

(in thousands)

 

 

%

 

 

(in thousands)

 

 

%

 

Clinical trial costs

 

$

1,578

 

 

 

50

%

 

$

2,728

 

 

 

63

%

 

$

5,173

 

 

 

50

%

 

$

8,206

 

 

 

62

%

Wages, benefits, and related costs

 

 

1,184

 

 

 

37

%

 

 

1,158

 

 

 

27

%

 

 

3,586

 

 

 

34

%

 

 

3,609

 

 

 

27

%

Preclinical supplies and equipment depreciation

 

 

318

 

 

 

10

%

 

 

365

 

 

 

8

%

 

 

1,203

 

 

 

12

%

 

 

1,105

 

 

 

9

%

Consulting, non-clinical trial services, and other

 

 

84

 

 

 

3

%

 

 

104

 

 

 

2

%

 

 

449

 

 

 

4

%

 

 

297

 

 

 

2

%

Total research and development expenses

 

$

3,165

 

 

 

 

 

$

4,355

 

 

 

 

 

$

10,412

 

 

 

 

 

$

13,217

 

 

 

 

 

30


 

We expense research and development costs as incurred. We record costs for certain development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment. We do not allocate employee-related costs, depreciation, rental and other indirect costs to specific research and development programs because these costs are deployed across multiple product programs under research and development.

Our current research and development activities primarily relate to clinical development in the following indications:

Alzheimer’s Disease. We initiated a randomized, placebo-controlled, multi-center phase 1/2a clinical study of pepinemab in AD, or the SIGNAL-AD trial, in 2021. This trial is based on evidence from the SIGNAL clinical trial in HD that showed treatment with pepinemab reduced cognitive decline and induced a sharp increase in glucose metabolism in the brain during HD disease progression as detected by conventional FDG-PET imaging. Previous studies in AD have shown that decline in glucose metabolism correlates with cognitive decline. In April 2023, we reached our enrollment target for the Phase 1b/2 SIGNAL-AD study evaluating pepinemab as a potential treatment for people with mild dementia due to AD. As of June 6, 2024, the last patient completed their last visit in the SIGNAL-AD Phase 1b/2 study of pepinemab treatment for Alzheimer’s disease. SIGNAL-AD topline data was reported by Eric Siemers, MD, Principal Investigator of the SIGNAL-AD trial at the Alzheimer's Association International Conference in Philadelphia on July 31, 2024. Additional efficacy data for SIGNAL-AD was reported by Elizabeth Evans, PhD, Senior VP Discovery and Translational Research and Chief Operating Officer on October 31, 2024 at the Clinical Trials on Alzheimer’s Disease Conference in Madrid, Spain.
Cancer Studies. We and others have shown that SEMA4D, the target of pepinemab, is highly expressed in head and neck cancer where it impedes recruitment and activation of cytotoxic T cells that can attack the tumor while also inducing differentiation of myeloid derived suppressor cells that inhibit any remaining tumoricidal immune activity. Head and neck cancer is, therefore, a cancer in which immunotherapy with pepinemab in combination with a checkpoint inhibitor such as KEYTRUDA could be uniquely effective. We have entered into a collaboration with Merck, Sharp & Dohme, who is supplying KEYTRUDA, for first-line treatment of head and neck cancer patients and have analyzed interim data from the first 36 patients in the study. In a similar arrangement, we are collaborating with Merck KGaA (EMD Serono in the U.S.), who is supplying Bavencio, another checkpoint inhibitor, for combination with pepinemab in pancreatic cancer. Pepinemab is also being evaluated by third parties in investigator-sponsored trials, or ISTs, for breast cancer, and in multiple “window of opportunity” studies in additional cancer indications.
Huntington’s Disease. We have currently paused our research efforts for HD. We evaluated pepinemab for the treatment of HD in our Phase 2 SIGNAL trial. Topline data for this trial, consisting of 265 subjects, was reported in late September 2020. Although the study did not meet its prespecified primary endpoints, it provided important new information, including evidence of cognitive benefit and a reduction in brain atrophy and increase in brain metabolic activity in patients with manifest disease symptoms. An improved study design would focus on patients with early signs of cognitive or functional deficits since they appeared to derive the greatest treatment benefit. The Company is evaluating its development strategy in terms of business opportunity and other near-term clinical activities. To advance planning for a potential phase 3 study of pepinemab in HD, we requested a Type C meeting with the FDA to discuss details of the study design and key endpoints. We received requested clarifications regarding suitable endpoints for regulatory review from the FDA, and these will be incorporated in a possible future phase 3 study.

 

 

 

31


 

Results of Operations

The following table set forth our results of operations for the periods presented (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenue

 

$

52

 

 

$

20

 

 

$

388

 

 

$

570

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,165

 

 

 

4,355

 

 

 

10,412

 

 

 

13,217

 

General and administrative

 

 

1,439

 

 

 

1,499

 

 

 

5,324

 

 

 

5,250

 

Total costs and expenses

 

 

4,604

 

 

 

5,854

 

 

 

15,736

 

 

 

18,467

 

Loss from operations

 

 

(4,552

)

 

 

(5,834

)

 

 

(15,348

)

 

 

(17,897

)

Interest expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1

)

Loss on settlement of warrants

 

 

(1,106

)

 

 

-

 

 

 

(1,106

)

 

 

-

 

Financing costs - warrant liabilities

 

 

-

 

 

 

-

 

 

 

(28

)

 

 

-

 

Change in fair value of warrant liabilities

 

 

(71

)

 

 

-

 

 

 

1,291

 

 

 

-

 

Change in fair value of derivative asset

 

 

-

 

 

 

-

 

 

 

(81

)

 

 

-

 

Other (expense) income, net

 

 

(3

)

 

 

922

 

 

 

12

 

 

 

964

 

Loss before provision for income taxes

 

 

(5,732

)

 

 

(4,912

)

 

 

(15,260

)

 

 

(16,934

)

Provision for income taxes

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Net loss attributable to Vaccinex, Inc.

 

$

(5,732

)

 

$

(4,912

)

 

$

(15,260

)

 

$

(16,934

)

 

Comparison of the Three Months Ended September 30, 2024 and 2023

Revenue

The Company recorded service revenue of $52,000 and $20,000 during the three months ended September 30, 2024 and 2023, respectively.

Operating Expenses

 

 

Three Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

$ Change

 

 

% Change

 

 

 

(in thousands)

 

 

 

 

Research and development

 

$

3,165

 

 

$

4,355

 

 

$

(1,190

)

 

 

(27

)%

General and administrative

 

 

1,439

 

 

 

1,499

 

 

 

(60

)

 

 

(4

)%

Total operating expenses

 

$

4,604

 

 

$

5,854

 

 

$

(1,250

)

 

 

(21

)%

 

Research and Development. Research and development expenses in the three months ended September 30, 2024 decreased by $1.2 million, or 27%, compared to the three months ended September 30, 2023. The decrease was primarily attributable to the winding down of the SIGNAL-AD trial, a pause in enrollment for the head and neck cancer trial, and less drug manufacturing costs.

 

General and Administrative. General and administrative expenses consist primarily of the necessary costs associated with maintaining the Company’s daily operations and administration of the Company’s business. General and administrative expenses in the three months ended September 30, 2024 were essentially the same when compared to the three months ended September 30, 2023.

 

 

32


 

Comparison of the Nine Months Ended September 30, 2024 and 2023

Revenue

The Company recorded service revenue of $388,000 and $70,000 during the nine months ended September 30, 2024 and 2023, respectively, and $500,000 in revenue during the nine months ended September 30, 2023 from our collaboration agreement with Surface Oncology.

 

Operating Expenses

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

$ Change

 

 

% Change

 

 

 

(in thousands)

 

 

 

 

Research and development

 

$

10,412

 

 

$

13,217

 

 

$

(2,805

)

 

 

(21

)%

General and administrative

 

 

5,324

 

 

 

5,250

 

 

 

74

 

 

 

1

%

Total operating expenses

 

$

15,736

 

 

$

18,467

 

 

$

(2,731

)

 

 

(15

)%

 

 

Research and Development. Research and development expenses in the nine months ended September 30, 2024 decreased by $2.8 million, or 21%, compared to the nine months ended September 30, 2023. The decrease was primarily attributable to the winding down of the SIGNAL-AD trial, a pause in enrollment for the head and neck cancer trial, and less drug manufacturing costs.

General and Administrative. General and administrative expenses consist primarily of the necessary costs associated with maintaining the Company’s daily operations and administration of the Company’s business. General and administrative expenses in the nine months ended September 30, 2024 were essentially the same when compared to the nine months ended September 30, 2023.

 

Liquidity and Capital Resources

To date, we have not generated any revenue from sales of our product candidates. Our recurring net losses and negative cash flows from operations raised substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our unaudited condensed financial statements. During the nine months ended September 30, 2024 and the year-ended December 31, 2023, we have generated a limited amount of revenue through the achievement of contractually stated milestones as well as grants, and the performance of services from collaboration agreements, including through our ActivMAb platform. See Note 1 of our unaudited condensed financial statements. Since our inception in 2001, we have relied on public and private sales of equity and debt financing to fund our operations, in addition to capital contributions from noncontrolling interests and limited-service revenue from collaboration agreements.

During the nine months ended September 30, 2024, the Company sold 208 shares of the Company’s common stock at a weighted average price per share of $10.30 through the Open Market Sale Agreement, for net proceeds of $2,077, respectively.

Additionally, during the nine months ended September 30, 2024 the Company received aggregate gross proceeds of approximately $14.1 million from (i) private placements of 433,865 shares of common stock, 90,363 pre-funded warrants and 717,228 warrants to purchase shares of common stock (ii) a public offering of 193,000 shares of common stock (iii) sale of 10 shares of our Series A Preferred Stock, and warrants to purchase up to 229,057 shares of our common stock, and (iv) exercise of warrants.

Series A Preferred Stock

On March 28, 2024, we sold shares of a newly designated series of our preferred stock, the Series A Preferred Stock. Our Series A Preferred Stock is convertible at the election of the holder at any time after the public announcement by the Company of top-line data from its SIGNAL-AD Alzheimer’s disease study (the “Data Release”) into shares of common stock at a conversion price equal to the greater of (a) $7.77 per share of common

33


 

stock and (b)(i) the volume weighted average price of the common stock for the last three trading days prior to delivery of the conversion notice if the common stock is traded on a trading market or if its prices are reported on OTCQB or OTCQX, (ii) the most recent bid price of the common stock if it is then traded on The Pink Open Market, or (iii) in all other cases the fair market value of the common stock as determined by an independent appraiser, which conversion right is subject to termination on the last full day preceding the proposed effective date for exercise of the Company’s redemption right or the date fixed for redemption upon a Deemed Liquidation Event (generally defined to include certain fundamental transactions involving the company including a merger or sale of substantially all of the Company’s assets) or on a liquidation, dissolution or winding up of the Company.

The Series A Preferred Stock is non-voting, has no mandatory redemption, and carries an annual 5% cumulative dividend, increasing by 2% each year, which dividend rate shall not exceed 12%. The Series A Preferred Stock will also participate on an as-converted basis in any regular or special dividends paid to holders of our common stock.

In addition, the Series A Preferred Stock has a liquidation preference equal to the greater of (i) $175,000 per share, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series A Preferred Stock (the “Original Share Price”), plus any accrued but unpaid dividends thereon, whether or not declared, together with any other dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series A Preferred Stock been converted into common stock immediately prior to such liquidation, dissolution, winding up or Deemed Liquidation Event.

The Company also agreed that so long as the Series A Preferred Stock is outstanding, the Company will not, without the written consent of the holders of 50.1% of the Series A Preferred Stock, (i) amend, alter, or repeal any provision of the Company’s certificate of incorporation or bylaws in a manner adverse to the Series A Preferred Stock or (ii) until March 29, 2026, incur any indebtedness for borrowed money in excess of $1.0 million.

The Company has the right to redeem the Series A Preferred Stock at a price equal to the Original Share Price per share at any time after a public announcement of an increase in pepinemab-treated patients relative to placebo-treated patients, with statistical significance having a p-value of less than or equal to 0.05, in the change of the FDG-PET standard uptake value ratio for brain metabolism between baseline and month 12 as assessed by [18F]fluorodeoxyglucose (FDG)-PET in the resting state following administration of 40 mg/kg pepinemab or placebo, as applicable, as described in the protocol for the Company’s SIGNAL-AD Alzheimer’s disease study and the associated Statistical Analysis Plan, provided that (i) the holder is not in possession of any material nonpublic information that was provided by the Company or any of its directors, directors, employees, agents, or affiliates and (ii) there is an effective resale registration statement on file covering the underlying common stock.

The holders of outstanding shares of Series A Preferred Stock have no voting rights with respect to such shares of Series A Preferred Stock on any matter presented to the Company’s stockholders, except as required by law or as specifically set forth in the Certificate of Designation of Series A Preferred Stock.

Operating Capital Requirements

Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party research services and amounts due to vendors for research supplies. As of September 30, 2024 and December 31, 2023, our principal source of liquidity was cash and cash equivalents in the amount of $2.9 million and $1.5 million, respectively. Given our projected operating requirements, our existing cash and cash equivalents and marketable securities, we will seek to complete an additional financing transaction or transactions in order to continue operations.

Since our inception in 2001, we have incurred significant net losses and negative cash flows from operations. For the nine months ended September 30, 2024 and 2023, we reported a net loss of $15.3 million and $16.9 million, respectively. For the nine months ended September 30, 2024 and 2023, we reported cash used in operations of $12.3 million and $13.6 million, respectively. As of September 30, 2024 and December 31, 2023, we had an accumulated deficit of $355.2 million and $339.9 million, respectively. We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates. We are subject to risks associated with the development of new

34


 

biopharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors, which may adversely affect our business.

Our recurring net losses and negative cash flows from operations, as well as forecast of continued losses and negative cash flows from operations, raised substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our financial statements for the year ended December 31, 2023. Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, we expect to finance our operations through the public or private sale of equity, debt financing, or other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. Our cash and cash equivalents were $2.9 million and total current assets were $4.8 million at September 30, 2024, which the Company is projecting will be insufficient to sustain its operations through one year following the date that the financial statements are issued.

Financing strategies we may pursue include, but are not limited to, the public or private sale of equity, debt financing or funds from other capital sources, such as government funding, collaborations, strategic alliances, or licensing arrangements with third parties. There can be no assurances additional capital will be available to secure additional financing, or if available, that it will be sufficient to meet our needs on favorable terms. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development of one or more of our product candidates. If we raise additional funds through the public or private sale of equity or debt financing, it could result in dilution to our existing stockholders or increased fixed payment obligations and these securities may have rights senior to those of our common stock and could contain covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license our intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition, and prospects.

Cash Flows

The following table summarizes our cash flows for the periods presented:

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Cash used in operating activities

 

$

(12,254

)

 

$

(13,642

)

Cash used in investing activities

 

 

(22

)

 

 

(67

)

Cash provided by financing activities

 

 

13,647

 

 

 

7,445

 

 

Operating Activities. We have historically experienced negative cash flows as we have developed our product candidates and continued to expand our business. Our net cash used in operating activities primarily results from our net loss adjusted for non-cash expenses and changes in working capital components as we have continued our research and development and is influenced by the timing of cash payments for research related expenses. Our primary uses of cash from operating activities are compensation and related expenses, employee-related expenditures, third-party research services and amounts due to vendors for research supplies. Our cash flows from operating activities will continue to be affected principally by the extent to which we increase spending on personnel, research and development and other operating activities as our business grows.

During the nine months ended September 30, 2024 and 2023, operating activities used $12.3 million and $13.6 million, respectively, in cash, primarily as a result of our continued efforts of discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs without any product revenue, resulting in a net loss of $15.3 million and $16.9 million, respectively.

Investing Activities. The investing activities during the nine months ended September 30, 2024 and 2023, were due to purchases of property and equipment.

Financing Activities. During the nine months ended September 30, 2024, financing activities provided $14.1 million, from the private placement of common stock and pre-funded warrants, with accompanying warrants, the

35


 

public offering of common stock and private placement of accompanying warrants, the sale of Series A Preferred Stock and accompanying warrants, and the exercise of warrants. During the nine months ended September 30, 2023, financing activities provided a net of $7.4 million, of which $6.3 million was due to private placements of common stock, $1.0 million through an award from the Alzheimer’s Drug Discovery Foundation in the form of an investment in our common stock and $0.2 million was due to the issuance of the Company’s common stock pursuant to the Open Market Sale Agreement.

Critical Accounting Policies and Estimates

Our unaudited condensed financial statements are prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosures. We evaluate our estimates and assumptions on an ongoing basis. Our estimates are based on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Our actual results could differ from these estimates.

There have been no material changes to our critical accounting policies and significant judgments during the nine months ended September 30, 2024, other than those discussed in Note 2 of our unaudited condensed financial statements as of and for the nine months ended September 30, 2024, included elsewhere in this quarterly report on Form 10-Q.

Impact of Recent Accounting Pronouncements

For a discussion on the impact of recent accounting pronouncements on our business, see Note 2 to our unaudited condensed financial statements.

36


 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

As a smaller reporting company, we are not required to provide the information required by this item.

Item 4. Controls and Procedures

Evaluation of disclosure controls and procedures

Our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer), with the participation of our management evaluated the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as of September 30, 2024, the end of the period covered by this Form 10-Q. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2024, our disclosure controls and procedures were effective.

Changes in internal control over financial reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended September 30, 2024 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

37


 

Part II - OTHER INFORMATION

Item 1A. Risk Factors

An investment in our stock involves a high degree of risk. You should carefully consider the risks set forth in this section, and in Part I, Item 1A of the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the "Annual Report"), and all of the other information set forth in this Report, the Annual Report, and in the other reports we file with the SEC. If any of the risks contained in those reports actually occur, our business, results of operation, financial condition, and liquidity could be harmed, the value of our securities could decline, and you could lose all or part of your investment. Except as set forth below, there have been no material changes from risk factors disclosed in the Annual Report on Form 10-K. See the discussion of the Company’s risk factors under Part I, Item 1A. of the Annual Report.

We are currently not in compliance with the continued listing standards of the Nasdaq Capital Market, and if we are unable to regain compliance, our common stock will be delisted from the exchange.

Our common stock is currently listed for trading on the Nasdaq Capital Market under the symbol “VCNX." The continued listing of our common stock on Nasdaq is subject to our compliance with a number of listing standards, including Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders’ equity (the “Equity Standard”) or the alternative requirements of having a market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years (the “Alternative Standards”). On April 11, 2024, Nasdaq informed us that based on the financial statements contained in our Form 10-K for the year-ended December 31, 2023, the Company is no longer in compliance with the Equity Standard or the Alternative Standards and we may be subject to delisting. The notification letter had no immediate effect on the Company’s listing on the Nasdaq Capital Market and the Company timely submitted a plan to regain compliance with the Equity Standard.

On June 5, 2024, Nasdaq notified the Company that it has been provided an extension to regain and evidence compliance with the Equity Standard on or before September 30, 2024. As of September 30, 2024, we had a stockholders' deficit of $1.3 million. On October 7, 2024, the Company received a letter from the Nasdaq Listing Staff stating that the Company had not regained compliance with the Equity Standard or the Alternatives Standards and that, as a result, unless the Company timely requested an appeal of this determination to a Nasdaq Hearings Panel, Nasdaq would move to suspend trading of the Company’s common stock and to have the Company’s securities delisted from the Nasdaq Capital Market. The Company timely appealed the determination, which automatically stayed any suspension or delisting action pending the Hearings Panel’s decision and the expiration of any additional extension period granted by the Hearings Panel following the hearing set for December 5, 2024. As a result, the Company’s common stock is expected to remain listed on the Nasdaq Capital Market through at least that time. However, there can be no assurance that the Hearings Panel will grant the Company’s request for continued listing or that the Company will be able to demonstrate compliance with the Equity Standard or the Alternative Standards within any additional compliance period that may be granted by the Hearings Panel.

A delisting or even notification of failure to comply with such requirements would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In addition, the delisting of our common stock could lead to a number of other negative implications such as a loss of media and analyst coverage, a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and likely result in a reduced level of trading activity in the secondary trading market for our securities, and materially adversely impact our ability to raise capital on acceptable terms or at all. Delisting from Nasdaq could also have other negative results, including the potential loss of confidence by our current or prospective third-party providers and collaboration partners, the loss of institutional investor interest, and fewer licensing and partnering opportunities. In the event of a delisting, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

38


 

If our common stock were no longer listed on Nasdaq, investors might only be able to trade on one of the over-the-counter markets, if at all. There is no assurance that prices for our common stock would be quoted on one of these other trading systems or that an active trading market for our common stock would exist, which would materially and adversely impact the market value of our common stock and your ability to sell our common stock.

The Series A Preferred Stock ranks senior to the Company’s common stock with respect to rights on the distribution of assets upon liquidation, dissolution and winding up.

The Series A Preferred Stock has a liquidation preference before our common stockholders equal to the greater of (i) $175,000 per share for a total of $1.75 million, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series A Preferred Stock (the “Original Share Price”), plus any accrued but unpaid dividends thereon, whether or not declared, together with any other dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series A Preferred Stock been converted into common stock immediately prior to such liquidation, dissolution, winding up or Deemed Liquidation Event. As of September 30, 2024, the holder of the shares of Series A preferred stock were entitled to a liquidation preference of $1.75 million, in the event of any liquidation, dissolution or winding up of the Company. Further, upon the occurrence of Deemed Liquidation Event (generally defined to include certain fundamental transactions involving the Company including a merger or sale of substantially all of the Company’s assets) or other liquidation of the Company, the holders of the Series A Preferred Stock will receive a distribution of the Company’s assets per their liquidation preference before any holders of common stock receive a distribution. As a result, in the event of a liquidation of the Company the proceeds received by the common stockholder may be reduced.

Shares of common stock issuable upon conversion of our Series A Preferred Stock will be dilutive to our existing shareholders upon conversion and adversely affect the market price of our common stock.

As of September 30, 2024, we had outstanding 10 shares of Series A Preferred Stock with an aggregate liquidation preference of $1.75 million. No shares of the outstanding Series A Preferred Stock are convertible before the public announcement by the Company of top-line data from its study “SEMA4D Blockade Safety and Brain Metabolic Activity in Alzheimer’s Disease (AD)” (the “Data Release”). The Data Release was made on July 31, 2024, but no shares of Series A Preferred Stock have to date been converted into shares of common stock. The issuance of common stock upon conversion of the Series A Preferred Stock would result in immediate dilution to existing holders of our common stock.

The Alzheimer’s Drug Discovery Foundation may be able to sell shares of our common stock in the public market, which may cause the market price of our common stock to decrease, and therefore make it more difficult to raise equity financing or issue equity as consideration in an acquisition.

Our registration rights agreement with the Alzheimer’s Drug Discovery Foundation requires us to register all shares of common stock held by the Alzheimer’s Drug Discovery Foundation issuable upon conversion of the Series A Preferred Stock and upon the exercise of certain warrants issued in connection with the Series A Preferred Stock under the Securities Act of 1933, as amended. The registration rights for the Alzheimer’s Drug Discovery Foundation allows it to sell its shares without compliance with the volume and manner of sale limitations under Rule 144 promulgated under the Securities Act and facilitates the resale of such securities into the public market. The market value of our common stock could decline as a result of sales by the Alzheimer’s Drug Discovery Foundation from time to time. In particular, the future sale of a substantial number of the shares of our common stock by the Alzheimer’s Drug Discovery Foundation within a short period of time, or the perception that such sale might occur, could cause our stock price to decrease, make it more difficult for us to raise funds through future offerings of our common stock or acquire other businesses in the future using our common stock as consideration for the purchase price.

 

 

39


 

Item 6. Exhibits

INDEX TO EXHIBITS

 

Exhibit No.

Description

 

 

 

4.1

 

Form of Common Stock Purchase Warrant (incorporated herein by reference from Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on September 19, 2024)

 

 

 

10.1

 

Form of Inducement Letter Agreement, by and between the Company and each purchaser identified on the signature pages thereto, dated as of September 17, 2024 (incorporated herein by reference from Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on September 19, 2024).

 

 

 

  31.1*

 

Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

  31.2*

 

Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

  32.1**

 

Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

101.INS

 

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents

 

   104

 

The cover page for the Company’s Quarterly Report on Form 10-Q has been formatted in Inline XBRL and contained in Exhibit 101

 

* Filed herewith.

** Furnished herewith.

 

40


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Vaccinex, Inc.

(Registrant)

November 14, 2024

By:

/s/ Maurice Zauderer

Maurice Zauderer, Ph.D.

President & Chief Executive Officer

(Principal Executive Officer)

November 14, 2024

By:

/s/ Jill Sanchez

Jill Sanchez, CPA

Chief Financial Officer

(Principal Financial Officer)

 

41


Exhibit 31.1

 

Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Maurice Zauderer, certify that:

 

1.

I have reviewed this quarterly report on Form 10-Q for the three months ended September 30, 2024, of Vaccinex, Inc.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a.

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b.

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c.

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d.

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

 

5.

The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

  a.

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

  b.

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

 

 

 

Dated: November 14, 2024

By:

/s/ Maurice Zauderer

Maurice Zauderer, Ph.D.

President and Chief Executive Officer

(Principal Executive Officer)

 


Exhibit 31.2

 

Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Jill Sanchez, certify that:

 

1.

I have reviewed this quarterly report on Form 10-Q for the three months ended September 30, 2024, of Vaccinex, Inc.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a.

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b.

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c.

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d.

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

 

5.

The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

  a.

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

  b.

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

 

 

 

Dated: November 14, 2024

By:

/s/ Jill Sanchez

Jill Sanchez

Chief Financial Officer

(Principal Financial Officer)

 


Exhibit 32.1

Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the quarterly report of Vaccinex, Inc., (the "Company") on Form 10-Q for the three months ended September 30, 2024 (the "Report"), I, Maurice Zauderer, Ph.D., President and Chief Executive Officer of the Company and Jill Sanchez, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

 

 

Dated: November 14, 2024

By:

/s/ Maurice Zauderer

Maurice Zauderer, Ph.D.

President and Chief Executive Officer

 

 

 

Dated: November 14, 2024

By:

/s/ Jill Sanchez

Jill Sanchez

Chief Financial Officer

 


v3.24.3
Document And Entity Information - shares
9 Months Ended
Sep. 30, 2024
Nov. 12, 2024
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Sep. 30, 2024  
Document Fiscal Year Focus 2024  
Document Fiscal Period Focus Q3  
Entity Current Reporting Status Yes  
Trading Symbol VCNX  
Entity Registrant Name Vaccinex, Inc.  
Entity Central Index Key 0001205922  
Current Fiscal Year End Date --12-31  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   2,599,728
Entity File Number 001-38624  
Entity Tax Identification Number 16-1603202  
Entity Address, Address Line One 1895 Mount Hope Avenue  
Entity Address, City or Town Rochester  
Entity Address, State or Province NY  
Entity Address, Postal Zip Code 14620  
City Area Code 585  
Local Phone Number 271-2700  
Entity Interactive Data Current Yes  
Title of 12(b) Security Common Stock, $0.0001 par value  
Security Exchange Name NASDAQ  
Document Quarterly Report true  
Document Transition Report false  
Entity Incorporation, State or Country Code DE  
v3.24.3
Condensed Balance Sheets (Unaudited) - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Current assets:    
Cash and cash equivalents $ 2,906,000 $ 1,535,000
Accounts receivable 985,000 961,000
Prepaid expenses and other current assets 852,000 853,000
Derivative asset 14,000  
Total current assets 4,757,000 3,349,000
Property and equipment, net 82,000 136,000
Operating lease right-of-use asset 15,000 146,000
TOTAL ASSETS 4,854,000 3,631,000
Current liabilities:    
Accounts payable 4,865,000 2,039,000
Accrued expenses 1,200,000 1,242,000
Deferred revenue 51,000 63,000
Current portion of long-term debt 44,000 75,000
Operating lease liability 15,000 146,000
Warrant liability 0 2,351,000
Total current liabilities 6,175,000 5,916,000
Long-term debt   26,000
TOTAL LIABILITIES 6,175,000 5,942,000
Commitments and contingencies (Note 6)
Stockholders’ equity (deficit):    
Convertible preferred stock (Series A), par value of $0.001 per share; 10,000,000 shares authorized, 10 shares issued and outstanding as of September 30, 2024, and no shares authorized, issued or outstanding as of December 31, 2023; with aggregate liquidation preference of $1,750,000 and $0 as of September 30, 2024 and December 31, 2023, respectively 1,522,000 0
Common stock, par value of $0.0001 per share; 100,000,000 shares authorized as of September 30, 2024, and December 31, 2023; 2,599,733 and 892,622 shares issued as of September 30, 2024 and December 31, 2023, respectively; 2,599,728 and 892,617 shares outstanding as of September 30, 2024 and December 31, 2023, respectively 1,000 0
Additional paid-in capital 352,354,000 337,627,000
Treasury stock, at cost; 5 shares of common stock as of September 30, 2024, and December 31, 2023, respectively (11,000) (11,000)
Accumulated deficit (355,187,000) (339,927,000)
TOTAL STOCKHOLDERS' EQUITY/(DEFICIT) (1,321,000) (2,311,000)
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 4,854,000 $ 3,631,000
v3.24.3
Condensed Balance Sheets (Unaudited) (Parenthetical) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Statement of Financial Position [Abstract]    
Convertible preferred stock (Series A), par value $ 0.001 $ 0.001
Convertible preferred stock (Series A), authorized 10,000,000 0
Convertible preferred stock (Series A), issued 10 0
Convertible preferred stock (Series A), outstanding 10 0
Convertible preferred stock (Series A), aggregate liquidation preference $ 1,750,000 $ 0
Common stock, par value $ 0.0001 $ 0.0001
Common stock, shares authorized 100,000,000 100,000,000
Common stock, shares issued 2,599,733 892,622
Common stock, shares outstanding 2,599,728 892,617
Treasury stock, common shares 5 5
v3.24.3
Condensed Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Income Statement [Abstract]        
Revenue $ 52,000 $ 20,000 $ 388,000 $ 570,000
Costs and expenses:        
Research and development 3,165,000 4,355,000 10,412,000 13,217,000
General and administrative 1,439,000 1,499,000 5,324,000 5,250,000
Total costs and expenses 4,604,000 5,854,000 15,736,000 18,467,000
Loss from operations (4,552,000) (5,834,000) (15,348,000) (17,897,000)
Interest expense       (1,000)
Loss on settlement of warrants (1,106,000)   (1,106,000)  
Financing costs - warrant liabilities     (28,000)  
Change in fair value of warrant liabilities (71,000)   1,291,000 0
Change in fair value of derivative asset 0   (81,000)  
Other income (expense), net (3,000) 922,000 12,000 964,000
Loss before provision for income taxes (5,732,000) (4,912,000) (15,260,000) (16,934,000)
Provision for income taxes 0 0 0 0
Net loss attributable to Vaccinex, Inc. common stockholders (5,732,000) (4,912,000) (15,260,000) (16,934,000)
Comprehensive loss $ (5,732,000) $ (4,912,000) $ (15,260,000) $ (16,934,000)
Net loss per share attributable to Vaccinex, Inc. common stockholders, basic $ (2.83) $ (15.25) $ (8.85) $ (59.95)
Net loss per share attributable to Vaccinex, Inc. common stockholders, diluted $ (2.83) $ (15.25) $ (8.85) $ (59.95)
Weighted-average shares used in computing net loss per share attributable to Vaccinex, Inc. common stockholders, basic 2,026,920 322,153 1,724,088 282,467
Weighted-average shares used in computing net loss per share attributable toVaccinex, Inc. common stockholders, diluted 2,026,920 322,153 1,724,088 282,467
v3.24.3
Condensed Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($)
$ in Thousands
Total
Preferred Stock
Common Stock
Additional Paid-in Capital
Treasury Stock
Accumulated Deficit
Private Placement Offerings
Private Placement Offerings
Common Stock
Private Placement Offerings
Additional Paid-in Capital
As Amended
As Amended
Additional Paid-in Capital
Balance at Dec. 31, 2022 $ 5,193 $ 0 $ 0 $ 324,880 $ (11) $ (319,676)          
Balance, Shares at Dec. 31, 2022   0 237,532   5            
Issuance of Common Shares 2,040     2,040              
Issuance of Common Shares, Shares     23,693                
Stock-based compensation 129     129              
Net loss (4,962)         (4,962)          
Balance at Mar. 31, 2023 2,400 $ 0 $ 0 327,049 $ (11) (324,638)          
Balance, Shares at Mar. 31, 2023   0 261,225   5            
Balance at Dec. 31, 2022 5,193 $ 0 $ 0 324,880 $ (11) (319,676)          
Balance, Shares at Dec. 31, 2022   0 237,532   5            
Net loss (16,934)                    
Balance at Sep. 30, 2023 (3,869) $ 0 $ 0 332,752 $ (11) (336,610)          
Balance, Shares at Sep. 30, 2023   0 347,038   5            
Balance at Mar. 31, 2023 2,400 $ 0 $ 0 327,049 $ (11) (324,638)          
Balance, Shares at Mar. 31, 2023   0 261,225   5            
Issuance of Common Shares 4,111     4,111              
Issuance of Common Shares, Shares     51,486                
Stock-based compensation 126     126              
Net loss (7,060)         (7,060)          
Balance at Jun. 30, 2023 (423) $ 0 $ 0 331,286 $ (11) (331,698)          
Balance, Shares at Jun. 30, 2023   0 312,711   5            
Issuance of Common Shares 1,351     1,351              
Issuance of Common Shares, Shares     34,327                
Stock-based compensation 115     115              
Net loss (4,912)         (4,912)          
Balance at Sep. 30, 2023 (3,869) $ 0 $ 0 332,752 $ (11) (336,610)          
Balance, Shares at Sep. 30, 2023   0 347,038   5            
Balance at Dec. 31, 2023 (2,311) $ 0 $ 0 337,627 $ (11) (339,927)          
Balance, Shares at Dec. 31, 2023   0 892,622   5            
Issuance of Common Shares 2     2              
Issuance of Common Shares, Shares     64,816                
Stock-based compensation 96     96              
Issuance of common stock and pre-funded warrants             $ 4,224 $ 1 $ 4,223    
Issuance of common stock and pre-funded warrants, Shares               626,867      
Issuance of warrants 556     556     $ 750   $ 750    
Issuance of preferred stock 1,236 $ 1,236                  
Issuance of preferred stock, Shares   10                  
Reclassification of public warrants, as amended 1,199     1,199              
Reclassification of private placement warrants                   $ 800 $ 800
Net loss (3,897)         (3,897)          
Balance at Mar. 31, 2024 2,655 $ 1,236 $ 1 345,253 $ (11) (343,824)          
Balance, Shares at Mar. 31, 2024   10 1,584,305   5            
Balance at Dec. 31, 2023 (2,311) $ 0 $ 0 337,627 $ (11) (339,927)          
Balance, Shares at Dec. 31, 2023   0 892,622   5            
Net loss (15,260)                    
Balance at Sep. 30, 2024 (1,321) $ 1,522 $ 1 352,354 $ (11) (355,187)          
Balance, Shares at Sep. 30, 2024   10 2,599,733   5            
Balance at Mar. 31, 2024 2,655 $ 1,236 $ 1 345,253 $ (11) (343,824)          
Balance, Shares at Mar. 31, 2024   10 1,584,305   5            
Stock-based compensation 112     112              
Amortization of preferred stock discount   $ 143   (143)              
Issuance of restricted stock, shares     543                
Net loss (5,631)         (5,631)          
Balance at Jun. 30, 2024 (2,864) $ 1,379 $ 1 345,222 $ (11) (349,455)          
Balance, Shares at Jun. 30, 2024   10 1,584,848   5            
Stock-based compensation 76     76              
Amortization of preferred stock discount   $ 143   (143)              
Exercise of warrants 5,211     5,211              
Exercise of warrants, shares     1,014,885                
Issuance of warrants 1,988     1,988              
Net loss (5,732)         (5,732)          
Balance at Sep. 30, 2024 $ (1,321) $ 1,522 $ 1 $ 352,354 $ (11) $ (355,187)          
Balance, Shares at Sep. 30, 2024   10 2,599,733   5            
v3.24.3
Condensed Statements of Cash Flows (Unaudited) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2024
Sep. 30, 2023
CASH FLOWS FROM OPERATING ACTIVITIES:      
Net loss $ (5,732,000) $ (15,260,000) $ (16,934,000)
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation 24,000 77,000 92,500
Stock-based compensation   284,000 370,000
Change in fair value of warrant liability 71,000 (1,291,000) 0
Change in fair value of derivative asset 0 81,000  
Loss on settlement of warrants 1,106,000 1,106,000  
Changes in operating assets and liabilities:      
Accounts receivable   (24,000) (758,000)
Prepaid expenses and other current assets   1,000 17,000
Accounts payable   2,826,000 2,707,000
Accrued expenses   (42,000) 864,000
Deferred revenue   (12,000)  
Net cash used in operating activities   (12,254,000) (13,642,000)
CASH FLOWS FROM INVESTING ACTIVITIES:      
Purchase of property and equipment   (22,000) (67,000)
Net cash used in investing activities   (22,000) (67,000)
CASH FLOWS FROM FINANCING ACTIVITIES:      
Proceeds from issuance of common stock, and pre-funded warrants in private placement offerings   2,529,000  
Proceeds from exercise of warrants   5,920,000  
Proceeds from issuance of warrants in private placement offerings   1,113,000  
Proceeds from private offering of common stock     6,234,000
Payments of long-term debt   (58,000) (57,000)
Proceeds from issuance of preferred stock and accompanying warrants   1,697,000  
Proceeds from issuance of common stock, and private placement warrants   2,446,000  
Proceeds from issuance of common stock     1,268,000
Net cash provided by financing activities   13,647,000 7,445,000
NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS   1,371,000 (6,264,000)
CASH AND CASH EQUIVALENTS–Beginning of period   1,535,000 6,391,000
CASH AND CASH EQUIVALENTS–End of period $ 2,906,000 2,906,000 $ 127,000
SUPPLEMENTAL DISCLOSURES OF NONCASH INVESTING AND FINANCING ACTIVITIES:      
Warrant inducement (transaction costs incurred but not paid)   $ 297,000  
v3.24.3
Pay vs Performance Disclosure - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Pay vs Performance Disclosure        
Net Income (Loss) $ (5,732) $ (4,912) $ (15,260) $ (16,934)
v3.24.3
Insider Trading Arrangements
3 Months Ended
Sep. 30, 2024
Trading Arrangements, by Individual  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
v3.24.3
Company and Nature of Business
9 Months Ended
Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Company and Nature of Business

Note 1. COMPANY AND NATURE OF BUSINESS

Vaccinex, Inc. (the “Company”) was incorporated in Delaware in April 2001 and is headquartered in Rochester, New York. The Company is a clinical-stage biotechnology company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, including neurodegenerative diseases, cancer, and autoimmune disorders. Since its inception, the Company has devoted substantially all of its efforts toward product research, manufacturing and clinical development, and raising capital.

The Company is subject to a number of risks and uncertainties common to other early-stage biotechnology companies including, but not limited to, dependency on the successful development and commercialization of its product candidates, rapid technological change and competition, dependence on key personnel and collaborative partners, uncertainty of protection of proprietary technology and patents, clinical trial uncertainty, fluctuation in operating results and financial performance, the need to obtain additional funding, compliance with governmental regulations, technological and medical risks, management of growth and effectiveness of marketing by the Company. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability.

Going Concern

These condensed financial statements have been prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

The Company has incurred significant losses and negative cash flows from operations since inception and expects to incur additional losses until such a time it can generate significant revenue from the commercialization of its product candidates. The Company reported cash used in operations of $12.3 million for the nine months ended September 30, 2024, and an accumulated deficit of $355.2 million as of September 30, 2024. Given the Company’s projected operating requirements and its existing cash and cash equivalents, the Company is projecting insufficient liquidity to sustain its operations and meet its obligations through one year following the date that the condensed financial statements are issued. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern.

In response to these conditions, management is currently evaluating different strategies to obtain the required funding of future operations. Financing strategies may include, but are not limited to, the public or private sale of equity, debt financing or funds from other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. There can be no assurances that the Company will be able to secure additional financing, or if available, that it will be sufficient to meet its needs or on favorable terms. Because management’s plans have not yet been finalized and are not within the Company’s control, the implementation of such plans cannot be considered probable. As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern.

The condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

v3.24.3
Summary of Significant Accounting Policies
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

Note 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation and Consolidation

The accompanying unaudited condensed financial statements reflect the accounts and operations of the Company and have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information (Accounting Standards Codification (“ASC”) 270, Interim Reporting) and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, these financial statements do not include all of the information necessary for a full presentation of financial position, results of operations, and cash flows in conformity with GAAP. In the opinion of management, the condensed financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented.

These condensed financial statements should be read in conjunction with the Company’s audited financial statements and related notes included in the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2023, filed with the SEC on April 25, 2024.

Common Stock Reverse Splits

On September 25, 2023, the Company effected a 1-for-15 reverse stock split of its issued shares of common stock. On February 19, 2024, the Company effected a second reverse split of shares of the Company's common stock on a 1-for-14 basis. All per share amounts, common shares outstanding, warrants, and stock-based compensation amounts for all periods presented have been retroactively adjusted to reflect these reverse stock splits. The shares of common stock retain a par value of $0.0001 per share.

Use of Estimates

These condensed financial statements have been prepared in conformity with U.S. GAAP. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the condensed financial statements and the reported amount of expenses during the reporting period. Such management estimates include those relating to assumptions used in the valuation of stock option awards, valuation of the warrant liabilities, valuation of the derivative asset, and valuation allowances against deferred income tax assets. Actual results could differ from those estimates.

Convertible Preferred Stock

In March 2024, the Company issued shares of a newly designated series of convertible preferred stock (see Note 9). The convertible preferred stock contained embedded redemption features requiring bifurcation and separate accounting apart from the convertible preferred stock host instrument. The Company recorded the fair value of the embedded redemption features as a derivative asset on the Company’s balance sheets in accordance with ASC Topic 815, Derivatives and Hedging. See Note 4 for the key inputs used in the fair value measurements of the derivative asset.

Fair Value of Financial Instruments

Financial instruments consist of cash, accounts receivable, derivative asset, accounts payable, accrued liabilities, long-term debt, warrant liabilities, and convertible preferred stock. Cash, accounts receivable, accounts payable, accrued liabilities, debt, and convertible preferred stock are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date of such amounts. Warrant liabilities and the derivative asset are measured at fair value on a recurring basis with the assumptions discussed in Note 4.

Concentration of Credit Risk, Other Risks and Uncertainties

The Company is subject to a number of risks, including, but not limited to, the lack of available capital; the possible delisting of our common stock from Nasdaq; possible failure of preclinical testing or clinical trials; inability to obtain regulatory approval of product candidates; competitors developing new technological innovations; potential interruptions in the manufacturing and commercial supply operations; unsuccessful commercialization strategy and launch plans for its proprietary drug candidates; risks inherent in litigation, including purported class actions; market acceptance of the Company’s products; and protection of proprietary technology.

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents. Cash equivalents are deposited in interest-bearing money market accounts. Although the Company deposits its cash with multiple financial institutions, cash balances may occasionally be in excess of the amounts insured by the Federal Deposit Insurance Corporation. Management believes the financial risk associated with these balances is minimal and has not experienced any losses to date.

The Company has historically raised capital in transactions with investors that include members of its board of directors and entities controlled by certain board members. As such, the Company's directors, directly and indirectly, control a significant ownership percentage of the Company. The Company can provide no assurances that future financing will be available in sufficient amounts or on terms acceptable to it or that its directors or entities controlled by certain board members will be willing or able to participate in future capital raises by the Company.

The Company depends on third-party manufacturers for the manufacture of drug substances and drug product for clinical trials. The Company also relies on certain third parties for its supply chain. Disputes with these third- party manufacturers or shortages in goods or services from third-party suppliers could delay the manufacturing of the Company’s product candidates and adversely impact its results of operations.

Recently Issued Accounting Pronouncements

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 requires disclosure of additional categories of information about federal, state, and foreign income taxes in the rate reconciliation table and more details about the reconciling items in some categories if items meet a quantitative threshold. The ASU requires entities to disclose income taxes paid, net of refunds, disaggregated by federal (national), state and foreign taxes for annual periods and to disaggregate the information by jurisdiction based on a quantitative threshold. The guidance makes several other changes to the disclosure requirements. The ASU is required to be applied prospectively, with the option to apply it retrospectively. The ASU is effective for fiscal years beginning after December 15, 2024. The Company is currently assessing the impact of the adoption of this guidance on its financial statements and disclosures.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. In addition, the ASU enhances interim disclosure requirements, clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, and contains other disclosure requirements. The ASU does not change how an entity identifies its operating segments, aggregates those operating segments, or applies the quantitative thresholds to determine its reportable segments. The ASU is required to be applied retrospectively to all periods presented in the financial statements. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently assessing the impact of the adoption of this guidance on its financial statements and disclosures.

v3.24.3
Balance Sheet Components
9 Months Ended
Sep. 30, 2024
Balance Sheet Related Disclosures [Abstract]  
Balance Sheet Components

Note 3. BALANCE SHEET COMPONENTS

Property and Equipment

Property and equipment consist of the following (in thousands):

 

 

 

As of
September 30, 2024

 

 

As of
December 31, 2023

 

Leasehold improvements

 

$

3,277

 

 

$

3,277

 

Research equipment

 

 

3,373

 

 

 

3,351

 

Furniture and fixtures

 

 

350

 

 

 

350

 

Computer equipment

 

 

250

 

 

 

250

 

Property and equipment, gross

 

 

7,250

 

 

 

7,228

 

Less: accumulated depreciation and amortization

 

 

(7,168

)

 

 

(7,091

)

Property and equipment, net

 

$

82

 

 

$

136

 

 

Depreciation expense related to property and equipment was $24,000 and $77,000 for the three and nine months ended September 30, 2024 and $31,000 and $92,500 for the three and nine months ended September 30, 2023, respectively.

 

Accrued Expenses

Accrued expenses consist of the following (in thousands):

 

 

 

As of
September 30, 2024

 

 

As of
December 31, 2023

 

 

 

 

 

 

 

 

Accrued clinical trial cost

 

$

649

 

 

$

853

 

Accrued payroll and related benefits

 

 

238

 

 

 

295

 

Accrued consulting and legal

 

 

204

 

 

 

58

 

Accrued other

 

 

109

 

 

 

36

 

Accrued expenses

 

$

1,200

 

 

$

1,242

 

v3.24.3
Fair Value Measurements of Financial Measurements
9 Months Ended
Sep. 30, 2024
Fair Value Disclosures [Abstract]  
Fair Value Measurements of Financial Measurements

Note 4. FAIR VALUE MEASUREMENTS OF FINANCIAL MEASUREMENTS

 

Assets and Liabilities Measured at Fair Value on a Nonrecurring Basis

Assets and liabilities recorded at fair value on a nonrecurring basis in the condensed balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Financial instruments consist of cash, accounts receivable, accounts payable, accrued liabilities, and long-term debt. Cash, accounts receivable, accounts payable, accrued liabilities, and debt are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date of such amounts.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

Fair value measurement standards also apply to certain financial assets and liabilities that are measured at fair value on a recurring basis (each reporting period). For the Company, these financial assets and liabilities include its cash equivalents deposited in money market funds, warrant liabilities, and the derivative asset. The Company does not have any nonfinancial assets or liabilities that are measured at fair value on a recurring basis.

The assets’ or liabilities’ fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

The following tables set forth the fair value of the Company’s financial assets and liabilities by level within the fair value hierarchy (in thousands):

 

 

 

As of September 30, 2024

 

 

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Money market fund

 

$

900

 

 

$

900

 

 

$

-

 

 

$

-

 

Derivative asset

 

 

14

 

 

 

-

 

 

 

-

 

 

 

14

 

Total Financial Assets

 

$

914

 

 

$

900

 

 

$

-

 

 

$

14

 

 

 

 

As of December 31, 2023

 

 

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Money market fund

 

$

1,337

 

 

$

1,337

 

 

$

-

 

 

$

-

 

Total Financial Assets

 

$

1,337

 

 

$

1,337

 

 

$

-

 

 

$

-

 

 

 

 

As of September 30, 2024

 

 

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liabilities - public warrants

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

Warrant liabilities - private placement warrants

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Total Financial Liabilities

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

 

 

As of December 31, 2023

 

 

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liabilities - public warrants

 

$

2,275

 

 

$

-

 

 

$

-

 

 

$

2,275

 

Warrant liabilities - private placement warrants

 

 

76

 

 

 

-

 

 

 

-

 

 

 

76

 

Total Financial Liabilities

 

$

2,351

 

 

$

-

 

 

$

-

 

 

$

2,351

 

 

The Company did not transfer any assets or liabilities measured at fair value on a recurring basis to or from Level 1, Level 2, and Level 3 during either of the nine months ended September 30, 2024, and 2023.

 

Fair Value Measurement of Warrant Liabilities

The Company uses the Black-Scholes pricing model to determine the fair value of its warrant liabilities using Level 3 inputs. Inputs used to determine the estimated fair value of the warrant liabilities include the fair value of the underlying stock at the valuation date, the term of the warrants, and the expected volatility of the underlying stock. The significant unobservable input used in the fair value measurement of the warrant liabilities is the estimated term of the warrants.

The key inputs into the respective valuation models used to estimate the fair value of the warrant liabilities at September 30, 2024, were as follows:

 

 

 

 

 

 

 

 

Public Warrants

 

 

Private Placement Warrants

 

 

 

Low

 

 

High

 

 

Low

 

 

High

 

Risk-free interest rate

 

 

3.81

%

 

 

5.40

%

 

 

4.08

%

 

 

5.40

%

Volatility

 

 

83

%

 

 

130

%

 

 

83

%

 

 

130

%

Dividend yield

 

 

0

%

 

 

0

%

 

 

0

%

 

 

0

%

Expected term (years)

 

 

0.003

 

 

 

4.760

 

 

 

0.003

 

 

 

5.010

 

Share price

 

$

6.000

 

 

$

9.310

 

 

$

6.000

 

 

$

9.310

 

The key inputs into the respective valuation models used to estimate the fair value of the warrant liabilities at December 31, 2023, were as follows:

 

 

 

 

 

 

 

Public Warrants

 

 

Private Placement Warrants

 

 

 

Low

 

 

High

 

 

Low

 

 

High

 

Risk-free interest rate

 

 

3.81

%

 

 

5.42

%

 

 

3.81

%

 

 

5.33

%

Volatility

 

 

99

%

 

 

113

%

 

 

102

%

 

 

113

%

Dividend yield

 

 

0

%

 

 

0

%

 

 

0

%

 

 

0

%

Expected term (years)

 

 

0.75

 

 

 

5.01

 

 

 

0.75

 

 

 

5.01

 

Share price

 

$

9.310

 

 

$

13.160

 

 

$

9.310

 

 

$

12.880

 

The following table summarizes the changes in fair value of the Company’s warrant liabilities that are recognized in the change in fair value of the warrant liabilities in the accompanying condensed statements of operations and comprehensive loss during the nine months ended September 30, 2024 (in thousands):

 

 

 

 

 

 

Public Warrants

 

 

Private Placement Warrants

 

 

Total

 

Warrant liabilities as of January 1, 2024

 

$

2,275

 

 

$

76

 

 

$

2,351

 

Issuance of warrants

 

 

-

 

 

 

1,113

 

 

 

1,113

 

Reclassified as equity

 

 

(1,199

)

 

 

(800

)

 

 

(1,999

)

Cancellation of warrants

 

 

(77

)

 

 

-

 

 

 

(77

)

Exercise of warrants

 

 

(90

)

 

 

(7

)

 

 

(97

)

Change in fair value

 

 

(909

)

 

 

(382

)

 

 

(1,291

)

Warrant liabilities as of September 30, 2024

 

$

-

 

 

$

-

 

 

$

-

 

 

There were no warrant liabilities reported in the Company's condensed balance sheet at September 30, 2023, or change in fair value of warrant liabilities in the accompanying condensed statements of operations and comprehensive loss during the nine months ended September 30, 2023.

 

Fair Value Measurement of the Derivative Asset

The fair value of the derivative asset is determined using a binomial lattice valuation model (“BLM”). The application of the BLM requires the use of several inputs and significant unobservable assumptions, including volatility. Significant judgment is required in determining the expected volatility of the Company’s derivative asset.

The following table provides quantitative information regarding measurement inputs used to estimate the fair value of the Level 3 asset at:

 

 

 

September 30, 2024

 

Risk-free interest rate

 

 

5.12

%

Expected volatility

 

 

40.00

%

Expected term (in years)

 

 

0.50

 

Exercise price (per share)

 

$

7.77

 

Number of shares

 

 

10

 

 

The following table presents the changes in the derivative asset during the nine months ended September 30, 2024 (in thousands):

 

 

 

 

 

Derivative asset as of January 1, 2024

 

$

-

 

Issuance of convertible preferred stock

 

 

95

 

Change in fair value

 

 

(81

)

Derivative asset as of September 30, 2024

 

$

14

 

 

v3.24.3
Collaboration Agreements
9 Months Ended
Sep. 30, 2024
Collaboration Agreements [Abstract]  
Collaboration Agreements

Note 5. COLLABORATION AGREEMENTS

Surface Oncology, Inc.

In November 2017, the Company entered into a research collaboration and license option agreement with Surface Oncology, Inc. (“Surface”) to identify and select antibodies against two target antigens, using the Company’s proprietary technology as described in the agreement. Under the agreement, Surface may purchase exclusive options, exercisable by providing a written notice to the Company, to obtain (i) an exclusive product license to make, use, sell and import products incorporating antibodies targeting the first antigen and (ii) an exclusive research tool license to use antibodies targeting the second antigen to perform research. Surface purchased the first option and exercised the second option, and we entered into an exclusive research tool license agreement with Surface in the third quarter of 2019.

Under the research collaboration and license option agreement, Surface paid an upfront technology access fee of $250,000 and makes milestone payments upon completion of each of four designated milestones for the first target antigen specified in the agreement. For the second target antigen, Surface is obligated to make payments to the Company based on time incurred by the Company in the conduct of the work plan described in the agreement. Surface is required to reimburse the Company for expenses incurred (i) in the conduct of the work plan as detailed in the research funding budget and (ii) for patent filings and prosecution of the Company’s program intellectual property as described in the agreement. The exercise of each option would also entail a license fee and annual maintenance fees, and in the case of the product license, royalties, and additional milestone payments. This agreement will expire upon the latest of the expiration of both research programs and all evaluation and testing periods. During the nine months ended September 30, 2023, the Company recorded $500,000 of revenue for achievement of a milestone event. In 2023 Surface terminated this exclusive research license agreement, for the first target, and therefore will not be required to pay the maintenance fee any longer. Surface Oncology has sublicensed this program for the second target to Coherus BioSciences, Inc. (“Coherus”), which is actively continuing phase 1/2 development of the second target. Coherus has assumed responsibility for the payment of the maintenance fee and other fees contemplated by the research collaboration and license option agreement for the second target.

v3.24.3
Commitments and Contingencies
9 Months Ended
Sep. 30, 2024
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

Note 6. COMMITMENTS AND CONTINGENCIES

Nasdaq Deficiency Notice

On April 11, 2024, the Company received a letter from the Listing Qualifications staff of Nasdaq notifying the Company that based on the financial statements contained in its Form 10-K for the year-ended December 31, 2023, it no longer complies with the requirement under Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders’ equity for continued listing on the Nasdaq Capital Market (the “Equity Standard”) or the alternative requirements of having a market value of listed securities of $35.0 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years (the “Alternative Standards”), and may be subject to delisting. The notification letter had no immediate effect on the Company’s listing on the Nasdaq Capital Market and the Company timely submitted a plan to regain compliance with the Equity Standard.

On June 5, 2024, Nasdaq notified the Company that it has been provided an extension to regain and evidence compliance with the Equity Standard on or before September 30, 2024. As of September 30, 2024, we have a stockholders' deficit of $1.3 million. On October 7, 2024, the Company received a letter from the Nasdaq Listing Staff stating that the Company had not regained compliance with the Equity Standard or the Alternatives Standards and that, as a result, unless the Company timely requested an appeal of this determination to a Nasdaq Hearings Panel, Nasdaq would move to suspend trading of the Company’s common stock and to have the Company’s securities delisted from the Nasdaq Capital Market. The Company timely appealed the determination, which automatically stayed any suspension or delisting action pending the Hearings Panel’s decision and the expiration of any additional extension period granted by the Hearings Panel following the hearing set for December 5, 2024. As a result, the Company’s common stock is expected to remain listed on the Nasdaq Capital Market through at least that

time. However, there can be no assurance that the Hearings Panel will grant the Company’s request for continued listing or that the Company will be able to demonstrate compliance with the Equity Standard or the Alternative Standards within any additional compliance period that may be granted by the Hearings Panel.

Cancellation of Warrants

A holder of certain of the warrants that we called for cancellation has notified the Company that it believes that the warrants it held are still outstanding. The number of shares represented by these canceled warrants represents approximately 8% of our outstanding shares as of September 30, 2024, on a pre-issuance basis. Should this misunderstanding continue and a resolution be required and reached, there could be adverse impacts to the Company, including the payment of damages or the issuance of additional shares of common stock. While the Company believes that it has meritorious defenses with respect to this matter, and intends to vigorously defend its position, the process of resolving these matters is inherently uncertain and may develop over a long period of time, and so it is not possible to predict the ultimate resolution of such matter.

Other Contingencies

The Company is subject to claims and assessments from time to time in the ordinary course of business. The Company records a provision for a liability when it believes that it is both probable that a liability has been incurred and the amount can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount.

In the normal course of business, the Company may become involved in legal proceedings. The Company will accrue a liability for such matters when it is probable that a liability has been incurred and the amount can be reasonably estimated. When only a range of possible loss can be established, the most probable amount in the range is accrued. If no amount within this range is a better estimate than any other amount within the range, the minimum amount in the range is accrued. The accrual for a litigation loss contingency might include, for example, estimates of potential damages, outside legal fees and other directly related costs expected to be incurred. As of September 30, 2024, and December 31, 2023 the Company was not involved in any material legal proceedings.

v3.24.3
Leases
9 Months Ended
Sep. 30, 2024
Leases [Abstract]  
Leases

Note 7. LEASES

The Company leases its facilities from 1895 Management, Ltd., a New York corporation controlled by an entity affiliated with a director of the Company, under non-cancellable operating leases. The lease agreement requires monthly rental payments of $15,048 through October 31, 2024. The Company entered into a lease extension in September 2024, requiring periodic rental payments, totaling $180,578, through October 2025. The Company is responsible for all maintenance, utilities, insurance, and taxes related to the facility. The Company has elected the practical expedient on not separating lease components from non-lease components.

The Company accounts for its leases under ASC 842, Leases. Leases with an initial term of 12 months or less are not recorded on the condensed balance sheet. The Company determines if an arrangement is a lease at inception. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and lease liabilities are recognized based on the present value of lease payments over the lease term. The leases do not provide an implicit rate so in determining the present value of lease payments, the Company uses its incremental borrowing rate for the applicable lease, which was 7.0%. The Company recognizes lease expense on a straight-line basis over the remaining lease term.

As of September 30, 2024, the future minimum payments for the operating leases total $15,048, less imputed interest of $87, for an operating lease liability of $14,961. For the nine months ended September 30, 2024, and 2023, cash paid for amounts included in the measurement of lease liabilities was $90,290 and $135,434, respectively.

Lease expense incurred under the operating lease for each of the three-month and nine-month periods ended September 30, 2024 and 2023 was $45,144 and, $135,434, respectively. Lease expense is a component of general and administrative expense.

v3.24.3
Long-term Debt
9 Months Ended
Sep. 30, 2024
Debt Instruments [Abstract]  
Long-term Debt

Note 8. LONG-TERM DEBT

On May 8, 2020, the Company received a loan under the Small Business Administration's Paycheck Protection Program (the "PPP Loan") in the amount of $1,133,600. The PPP Loan originally matured on May 8, 2022, with no principal payments required prior to the maturity date, and bearing interest at an annual rate of 1.0%, with interest payments commencing on November 8, 2020, less the amount of any potential forgiveness. On November 8, 2021, the Company was awarded loan forgiveness of $876,171 and the remaining balance of the loan was refinanced. The loan has a maturity date of May 8, 2025, bears interest of 1%, and is being repaid in monthly payments of $6,334. The Company has recorded interest expense of $141 and $585 for the three-and nine-month periods ended September 30, 2024, respectively, and $336 and $1,141 for the three-and nine-month periods ended September 30, 2023, respectively, on its condensed statements of operations and comprehensive loss.

v3.24.3
Convertible Preferred Stock
9 Months Ended
Sep. 30, 2024
Class of Stock Disclosures [Abstract]  
Convertible Preferred Stock [Text Block]

Note 9. CONVERTIBLE PREFERRED STOCK

On March 28, 2024, the Company entered into a securities purchase agreement with the Alzheimer’s Drug Discovery Foundation pursuant to which the Company sold shares of a newly designated series of convertible preferred stock, the Series A Preferred Stock, and warrants to purchase up to 229,057 shares of the Company’s common stock (“ADDF Warrants”) for an aggregate purchase price of $1.75 million. See Note 10, ADDF Warrants. Our Series A Preferred Stock is convertible at the election of the holder at any time after the public announcement by the Company of top-line data from its SIGNAL-AD Alzheimer’s disease study (the “Data Release”) into shares of common stock at a conversion price equal to the greater of (a) $7.77 per share of common stock and (b)(i) the volume weighted average price of the common stock for the last three trading days prior to delivery of the conversion notice if the common stock is traded on a trading market or if its prices are reported on OTCQB or OTCQX, (ii) the most recent bid price of the common stock if it is then traded on The Pink Open Market, or (iii) in all other cases the fair market value of the common stock as determined by an independent appraiser, which conversion right is subject to termination on the last full day preceding the proposed effective date for exercise of the Company’s redemption right or the date fixed for redemption upon a Deemed Liquidation Event (generally defined to include certain fundamental transactions involving the company including a merger or sale of substantially all of the Company’s assets) or on a liquidation, dissolution or winding up of the Company.

The Series A Preferred Stock is non-voting, has no mandatory redemption, and carries an annual 5% cumulative dividend, increasing by 2 percentage points each year, which dividend rate shall not exceed 12%. The Series A Preferred Stock will also participate on an as-converted basis in any regular or special dividends paid to holders of our common stock.

In addition, the Series A Preferred Stock has a liquidation preference equal to the greater of (i) $175,000 per share, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series A Preferred Stock (the “Original Share Price”), plus any accrued but unpaid dividends thereon, whether or not declared, together with any other dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series A Preferred Stock been converted into common stock immediately prior to such liquidation, dissolution, winding up or Deemed Liquidation Event.

The Company also agreed that so long as the Series A Preferred Stock is outstanding, the Company will not, without the written consent of the holders of 50.1% of the Series A Preferred Stock, (i) amend, alter, or repeal any provision of the Company’s certificate of incorporation or bylaws in a manner adverse to the Series A Preferred Stock or (ii) until March 29, 2026, incur any indebtedness for borrowed money in excess of $1.0 million.

The Company has the right to redeem the Series A Preferred Stock at a price equal to the Original Share Price per share at any time after a public announcement of an increase in pepinemab-treated patients relative to placebo-treated patients, with statistical significance having a p-value of less than or equal to 0.05, in the change of the FDG-PET standard uptake value ratio for brain metabolism between baseline and month 12 as assessed by [18F]fluorodeoxyglucose (FDG)-PET in the resting state following administration of 40 mg/kg pepinemab or placebo, as applicable, as described in the protocol for the Company’s SIGNAL-AD Alzheimer’s disease study and the associated Statistical Analysis Plan, provided that (i) the holder is not in possession of any material nonpublic information that was provided by the Company or any of its directors, employees, agents, or affiliates and (ii) there is an effective resale registration statement on file covering the underlying common stock.

The Series A Preferred Stock have similar characteristics of an “Increasing Rate Security” as described by SEC Staff Accounting Bulletin Topic 5Q, Increasing Rate Preferred Stock. As a result, the discount on Series A Preferred Stock is considered an unstated dividend cost that is amortized over the period preceding commencement of the perpetual dividend using the effective interest method, by charging imputed dividend cost against retained earnings, or additional paid in capital in the absence of retained earnings and increasing the carrying amount of the Series A Preferred Stock by a corresponding amount, to accrete the initial recognized value to its expected settlement value on the expected redemption date. The amortization in each period is the amount which, together with the stated dividend in the period, results in a constant rate of effective cost with regard to the carrying amount of the Series A Preferred Stock.

Each share of Series A Preferred Stock contains redemption features which allow for the redemption of the Series A Preferred Stock in the event of a voluntary or involuntary liquidation, dissolution, winding up of the Company, or Deemed Liquidation Event, as defined in the certificate of designations (“liquidation events”). Upon the occurrence of such qualifying liquidation event, the Series A Preferred Stock holder shall be entitled to receive cash or assets of the Company before any distribution or payment may be made to or set apart for the holders of common stock in an amount per share of Series A Preferred Stock equal to, or greater of, (i) $175,000 plus all accrued and unpaid dividends thereon, whether or not declared (the "Liquidation Preference”); or (2) the amount per share the holder would receive if such holder converted the shares of Series A Preferred Stock immediately prior to the date of such payment, with certain additional conditions.

The embedded redemption features require the Company to settle the Series A Preferred Stock at the Liquidation Preference amount upon the occurrence of certain qualifying liquidation events. The holder’s exercise of the embedded conversion feature when the volume weighted average price of the Common Stock for the last three trading days is greater than $7.77, as defined in the certificate of designations, settles the Series A Preferred Stock through the issuance of a variable number of Common Stock in a fixed monetary amount of $175,000 per share. As these embedded features provide for settlement in nominal amounts not associated with its underlyings, the embedded features each meet the definition of a derivative.

Under ASC 815, certain contractual terms that meet the accounting definition of a derivative must be accounted for separately from the financial instrument in which they are embedded (Note 2). The Company has concluded that the redemption features and the holder’s option to convert when the volume weighted average price of the Common Stock for the last three trading days is greater than $7.77, as defined in the certificate of designations, constitute embedded derivative and, therefore, require bifurcation from the Series A Preferred Stock.

In the event of any liquidation or deemed liquidation event, as defined in the certificate of designations, before any distribution or payment may be made to or set apart for the holders of common stock, the Series A Preferred Stock holder is entitled to receive assets from the Company equal to $175,000 plus all accrued and unpaid dividends thereon, whether or not declared, per share for a total liquidation value of $1.75 million as of September 30, 2024. These redemption provisions were determined to represent embedded derivatives requiring bifurcation from the Series A Preferred Stock.

Upon initial issuance, the Company recorded the fair value of the embedded derivatives in the amount of $95 thousand as a derivative asset and premium on the Series A Preferred Stock. The derivative is adjusted to fair value at each reporting period with the change in the fair value recorded in earnings.

Accordingly, based upon the relative fair values of the instruments on the date of issuance, the Company allocated approximately $0.57 million of the gross proceeds to the ADDF Warrants and $1.18 million of the gross proceeds to the Series A Preferred Stock which is net of $95 thousand, attributed to the derivative asset.

v3.24.3
Warrants
9 Months Ended
Sep. 30, 2024
Warrants and Rights Note Disclosure [Abstract]  
Warrants

Note 10. WARRANTS

Public Warrants

On October 3, 2023, the Company sold in a public offering (i) 542,857 shares of the Company’s common stock together with public warrants to purchase up to 542,857 shares of common stock and (ii) in lieu of shares of common stock, pre-funded warrants exercisable for 142,857 shares of common stock together with public warrants

to purchase up to 142,857 shares of common stock (the “Offering”). Each public warrant had an initial exercise price equal to $14.00 per share. The public warrants were immediately exercisable and had an expiration date five years from the date of issuance. The shares of common stock and accompanying public warrants were sold at a combined public offering price of $14.00 per share and the accompanying public warrant, and the pre-funded warrants and accompanying public warrants were sold at a combined public offering price of $13.986 per pre-funded warrant and accompanying public warrant, for aggregate gross proceeds of $9.6 million, before deductions for placement agent and offering fees payable by the Company. The public warrants were generally subject to limitations on exercise if the aggregate number of common stock beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation; provided, however, that a holder could increase or decrease the beneficial ownership limitation by giving 61 days’ notice to the Company, but not to any percentage in excess of 9.99%. On July 18, 2024 the 142,857 pre-funded warrants were exercised and converted to common shares.

The Company had the right to “call” any portion of a holder’s public warrants by delivering a call notice to the holder within 30 days after the Company publicly announced an increase in pepinemab-treated patients relative to placebo-treated patients, with statistical significance having a p-value of less than or equal to 0.05, in the change of the FDG-PET standard uptake value ratio for brain metabolism between baseline and month 12 as assessed by [18F]fluorodeoxyglucose (FDG)-PET in the resting state following administration of 40 mg/kg pepinemab or placebo, as applicable, as described in the protocol for the Company’s SIGNAL-AD Alzheimer’s disease study and the associated Statistical Analysis Plan (the “Positive Data Release”). After delivery of a call notice, the public warrants would continue to be exercisable. Each public warrant would be canceled and no longer exercisable to the extent the holder failed to timely exercise the public warrant for the called portion thereof within 20 trading days following the Company’s issuance of a call notice.

In the event of a fundamental transaction, the public warrants required the Company to make a payment based on a Black-Scholes pricing model valuation, using specific inputs that precluded the instruments from being considered indexed to the Company’s own stock in accordance with ASC 815. The public warrants also contained certain terms that provided for an adjustment in response to the occurrence or nonoccurrence of a specified event that is inconsistent with an implicit assumption in a standard valuation model, which also precluded the instruments from being considered indexed to the Company’s stock in accordance with ASC 815. Therefore, upon issuance, the Company accounted for the public warrants as liabilities, which were recorded at the issuance date fair value of approximately $3.5 million.

In March 2024, the Company entered into warrant amendment agreements with holders of approximately 83% of the public warrants issued in the Offering to amend aforementioned terms in the public warrants. The public warrants, as amended, were no longer precluded from being considered indexed to the Company's stock in accordance with ASC 815. As a result, $1.2 million of the public warrant liabilities were reclassified as equity in the Company's condensed statements of stockholders' equity (deficit) for the nine months ended September 30, 2024. In addition, the public warrants, as amended, were marked to fair value on the amendment date resulting in a gain on change in fair value of warrant liabilities of $0.7 million in the Company's condensed statements of operations and comprehensive loss for the nine months ended September 30, 2024.

Private Placement Warrants

In November 2023, pursuant to securities purchase agreements entered into with certain investors, the Company issued and sold private placement warrants to purchase 37,694 shares of common stock. Each private placement warrant had an exercise price which was subject to proportional adjustments in the event of stock splits, combinations (including reverse stock splits), or similar events. The private placement warrants are immediately exercisable and expire five years from the date of issuance and the Company had the right to “call” any portion of the private placement warrants under the same conditions and terms as the public warrants. The private placement warrants were subject to the same beneficial ownership limitations as the public warrants and the pre-funded warrants. Upon issuance, the private placement warrants were precluded from being considered indexed to the Company’s own stock in accordance with ASC 815. Therefore, at issuance, the private placement warrants were liability-classified and recorded at their respective issuance date fair values.

On February 6, 2024, the Company entered into a securities purchase agreement pursuant to which we issued and sold 274,182 shares of our common stock together with private placement warrants to purchase up to 274,182 shares of common stock and (ii) pre-funded warrants to purchase up to 90,363 shares of common stock together with private placement warrants to purchase up to 90,363 shares of our common stock (the “February 2024 SPA”). Each private placement warrant was immediately exercisable and had an initial exercise price of $14.00 per share. The shares of common stock and accompanying private placement warrants were sold at a combined price of $10.15 per share and the accompanying private placement warrant, and the pre-funded warrants and accompanying private placement warrants were sold at a combined price of $10.1486 per pre-funded warrant and accompanying private placement warrant, for aggregate gross proceeds of approximately $3.7 million.

The Company had the right to “call” the exercise of any portion of a holder’s private placement warrants by delivering a call notice to the holder within 30 days, in the case of the November private placement warrants, or 120 days in the case of the February private placement warrants, after the Positive Data Release. After delivery of a call notice, the private placement warrants will continue to be exercisable. Each private placement warrant would be canceled and no longer exercisable to the extent the holder failed to timely exercise the private placement warrant for the called portion thereof within 20 trading days, in the case of the November private placement warrants, or 30 trading days in the case of the February private placement warrants, following the Company’s issuance of a call notice, provided that to the extent the exercise of a called portion of a private placement warrant would cause the holder to hold common stock in excess of a specified beneficial ownership limitation, upon exercise of such portion, as set forth in the private placement warrant, instead of shares being issued, the exercise would result in the modification of the terms of such portion to be consistent with the terms of the pre-funded warrant. Upon issuance, the private placement warrants were precluded from being considered indexed to the Company’s own stock in accordance with ASC 815. Therefore, at issuance, the private placement warrants were liability-classified and recorded at their issuance date fair value.

In March 2024, the Company entered into warrant amendment agreements with holders of 100% of the private placement warrants issued in November 2023 and holders of 97% of the private placement warrants issued in the February 2024 SPA to amend the aforementioned terms in the private placement warrants. As a result, 354,693 of the November 2023 and February 2024 SPA private placement warrants, as amended, were no longer precluded from being considered indexed to the Company's stock in accordance with ASC 815. The Company reclassified $0.8 million of the amended private placement warrants, as equity, in the Company's condensed statements of stockholders' equity/deficit for the nine months ended September 30, 2024, based on the guidance provided under ASC 815-40. The private placement warrants, as amended, were marked to fair value on the amendment date resulting in a gain on change in fair value of warrant liabilities of $0.36 million in the Company's condensed statements of operations and comprehensive loss for the nine months ended September 30, 2024.

On March 27, 2024, the Company entered into a securities purchase agreement pursuant to which the Company issued and sold 193,000 shares of the Company's common stock in a public offering together with private placement warrants to purchase up to 193,000 shares of common stock in a concurrent private placement at a combined price of $7.77 per share and accompanying private placement warrant for an aggregate purchase price of approximately $1.5 million. The Company had the right to “call” any portion of these private placement warrants under the same conditions and terms as the public warrants and the November private placement warrants. Separately on March 27, 2024, the Company entered into a securities purchase agreement in a different form pursuant to which the Company sold 159,683 shares of common stock and private placement warrants to purchase up to 159,683 shares of common stock in a private placement at a combined price of $7.77 per share and accompanying private placement warrant for an aggregate purchase price of approximately $1.25 million. The Company had the right to “call” any portion of these private placement warrants under the same conditions and terms as the February private placement warrants.

The Company evaluated the March 2024 private placement warrants and concluded that they met the criteria to be classified within stockholders’ equity within additional paid-in-capital. These private placement warrants are equity classified because they (1) are freestanding financial instruments that are legally detachable and separately exercisable from the common stock, (2) are immediately exercisable, (3) do not embody an obligation for the Company to repurchase its shares, (4) permit the holder to receive a fixed number of shares of common stock upon exercise, (5) are indexed to the Company's common stock and (6) meet the equity classification criteria.

Accordingly, the Company allocated approximately $0.84 million of the proceeds remaining (after the allocation of proceeds to the common stock in the amount equal to their issuance date fair value) to the March private placement warrants on a relative fair value basis for recognition in additional paid-in capital on the date of issuance.

 

Call of Public Warrants and Private Placement Warrants

In August 2024, the Company called for cancellation the public warrants and the private placement warrants, pursuant to terms of the warrants permitting the Company to call the warrants for cancellation following the announcement of a statistically significant increase in FDG-PET signal in patients in the Company’s SIGNAL-AD trial of pepinemab for the treatment of Alzheimer’s disease. All of the public warrants and private placement warrants not exercised pursuant to the Inducement Letter Agreements were thereafter canceled in September 2024. As of September 30, 2024, none of the private placement warrants or the public warrants were outstanding.

Inducement Transaction

On September 17, 2024, the Company entered into inducement letter agreements (the “Inducement Letter Agreements”) with holders (the “Holders”) of existing warrants to purchase up to an aggregate of 1,067,492 shares of the Company’s common stock, par value $0.0001 per share, originally issued to the Holders between October 2023 and March 2024 as public warrants or private placement warrants (the “Existing Warrants”). Pursuant to the Inducement Letter Agreements, the Holders agreed to exercise for cash the Existing Warrants at a reduced exercise price of $5.636 per share in consideration of the Company’s agreement to issue new unregistered common warrants (the “New Warrants”) to purchase up to 1,601,238 shares of common stock (the “New Warrant Shares”), which were issued and sold in a private placement at a price of $0.125 per New Warrant. Each New Warrant had an initial exercise price equal to $5.636 per share, was immediately exercisable, and expires September 18, 2029. Included in the exercise of the Existing Warrants were the public warrants issued in the Offering and the private placement warrants issued in the February 2024 SPA, which had not been reclassified to equity in March 2024. The Company revalued the Offering public warrants and the February 2024 SPA liability classified private placement warrants on September 17, 2024, resulting in a fair value of $0.2 million. The decrease in the fair value of the common stock warrant liability throughout the year resulted in an offsetting gain on common stock warrant liabilities in the Statements of Operations.

The exercise of the Existing Warrants resulted in the Company issuing 872,028 shares of common stock and, pursuant to terms of the Existing Warrants, the pre-funding of 195,464 shares of common stock underlying Existing Warrants where the applicable Holder would have exceeded a specified beneficial ownership limitation contained in the applicable Existing Warrant if shares of common stock had been issued.

The gross proceeds to the Company from the exercise of the Existing Warrants and the sale of the New Warrants are approximately $6.2 million, prior to deducting financial advisory fees and estimated transaction expenses. The closing of the transactions contemplated by the Inducement Letter Agreements occurred in part on September 18, 2024 and in part on September 19, 2024.

ADDF Warrants

In connection with the securities purchase agreement with the Alzheimer’s Drug Discovery Foundation, the Company sold ADDF Warrants to purchase up to 229,057 shares of common stock. Each ADDF Warrant has an initial exercise price equal to $7.64 per share, subject to proportional adjustments in the event of stock splits, combinations (including reverse stock splits), or similar events. These ADDF Warrants are immediately exercisable and will expire on March 29, 2029.

The Company evaluated the ADDF Warrants and concluded they met the criteria to be classified within stockholders’ equity within additional paid-in-capital. The ADDF Warrants are equity classified because they (1) are freestanding financial instruments that are legally detachable and separately exercisable from the common stock, (2)

are immediately exercisable, (3) do not embody an obligation for the Company to repurchase its shares, (4) permit the holder to receive a fixed number of shares of common stock upon exercise, (5) are indexed to the Company's common stock and (6) meet the equity classification criteria.

As of September 30, 2024, all of the ADDF warrants were outstanding.

Pre-Funded Warrants

In connection with the exercise of Existing Warrants in the September 2024 inducement transaction, the Company pre-funded 195,464 shares of common stock underlying Existing Warrants where the applicable Holder would have exceeded a specified beneficial ownership limitation contained in the applicable Existing Warrants if shares of common stock had been issued.

In connection with the February 2024 SPA, the Company sold pre-funded warrants exercisable for 90,363 shares of common stock. Each pre-funded warrant has an initial exercise price equal to $0.0014 per share, subject to proportional adjustments in the event of stock splits, combinations (including reverse stock splits), or similar events. The pre-funded warrants may be exercised at any time and will not expire until exercised in full. The pre-funded warrants are subject to the same beneficial owner limitations as the private placement warrants.

The Company evaluated the pre-funded warrants and concluded that they met the criteria to be classified within stockholders’ equity within additional paid-in-capital. The pre-funded warrants are equity classified because they (1) are freestanding financial instruments that are legally detachable and separately exercisable from the common stock, (2) are immediately exercisable, (3) do not embody an obligation for the Company to repurchase its shares, (4) permit the holder to receive a fixed number of shares of common stock upon exercise, (5) are indexed to the Company's common stock and (6) meet the equity classification criteria.

Accordingly, the Company allocated approximately $0.9 million of the proceeds remaining (after the allocation of proceeds to the liability-classified private placement warrants in the amount equal to their issuance date fair value) to the pre-funded warrants on a relative fair value basis for recognition in additional paid-in capital on the date of issuance.

As of September 30, 2024, all of the February 2024 SPA pre-funded warrants and pre-funded shares in connection with the September 2024 inducement transaction were outstanding.

v3.24.3
Common Stock Reserved For Issuance
9 Months Ended
Sep. 30, 2024
Equity [Abstract]  
Common Stock Reserved For Issuance

Note 11. COMMON STOCK RESERVED FOR ISSUANCE

Common stock has been reserved for the following potential future issuance:

 

 

 

As of
September 30, 2024

 

 

As of
December 31, 2023

 

Shares underlying outstanding stock options

 

 

84,358

 

 

 

14,323

 

Shares available for future stock option grants

 

 

3,318

 

 

 

528

 

Shares underlying outstanding public warrants

 

 

-

 

 

 

685,714

 

Shares underlying outstanding private placement warrants

 

 

1,830,297

 

 

 

37,694

 

Shares underlying convertible preferred stock-if converted

 

 

225,225

 

 

 

-

 

Shares underlying outstanding pre-funded warrants

 

 

285,827

 

 

 

142,857

 

Total shares of common stock reserved

 

 

2,429,025

 

 

 

881,116

 

v3.24.3
Stock-Based Compensation
9 Months Ended
Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]  
Stock-Based Compensation

Note 12. STOCK-BASED COMPENSATION

2011 Employee Equity Plan

In connection with the adoption of the Company’s 2018 Omnibus Incentive Plan in August 2018, the Company ceased granting stock options under the Company’s 2011 Employee Equity Plan (the “2011 Plan”). However, the 2011 Plan will continue to govern the terms and conditions of the outstanding stock options previously granted thereunder. Any shares of stock related to awards outstanding under the 2011 Plan that terminate by expiration, forfeiture, cancellation, or otherwise without the issuance of such shares will become available for grant under the 2018 Omnibus Incentive Plan. Stock options granted under the 2011 Plan expire in five or ten years from the date of grant.

2018 Omnibus Incentive Plan

In August 2018, the Company’s board of directors adopted, and its stockholders approved, the 2018 Omnibus Incentive Plan, which allows for the granting of restricted stock, stock options, and stock appreciation rights awards to employees, advisors, and consultants.

On June 22, 2018, the Company’s Board of Directors adopted the First Amendment to the 2018 Omnibus Incentive Plan, subject to stockholder approval, to (i) add a one-time automatic increase in the shares of common stock issuable under the 2018 Plan, (ii) increase the percentage by which the shares of common stock issuable under the 2018 Plan automatically increase each year, and (iii) extend the term of the 2018 Plan to March 21, 2034. On May 9, 2024, the Company’s stockholders approved the First Amendment to the 2018 Omnibus Incentive Plan.

Stock options granted under the 2018 Omnibus Incentive Plan, as amended (the “2018 Plan”) may be either incentive stock options or non-statutory stock options. Incentive stock options may be granted to employees, advisors, and consultants at exercise prices of no less than the fair value of the common stock on the grant date. If at the time of grant, the optionee owns stock representing more than 10% of the voting power of all classes of stock of the Company, the exercise price must be at least 110% of the fair value of the common stock on the grant date as determined by the board of directors. Non-statutory stock options may be granted to employees, advisors and consultants at exercise prices of less than the fair market value of a share of common stock on the date the non-statutory stock option is granted but shall under no circumstances be less than adequate consideration as determined by the board of directors for such a share. The vesting period of stock option grants is determined by the board of directors, ranging from zero to eight years. Stock options granted under the 2018 Plan expire in five or ten years from the date of grant.

The Company initially reserved 2,024 shares of common stock for issuance, subject to certain adjustments, pursuant to awards under the 2018 Plan. Any shares of common stock related to awards outstanding under the 2011 Plan as of the effective date of the 2018 Plan, which thereafter terminate by expiration, forfeiture, cancellation or otherwise without the issuance of such shares, will be added to, and included in, the number of shares of common stock available for grant under the 2018 Plan. In addition, (i) on May 9, 2024, the number of shares of common stock reserved for issuance under the 2018 Plan automatically increased by 55,422 shares, which represented 4.5% of the total number of shares of common stock outstanding on March 22, 2024, and (ii) on each January 1st effective January 1, 2020 through January 1, 2024 and from January 1, 2025 and continuing until the expiration of the 2018 Plan, the number of shares of common stock available for issuance under the 2018 Plan will automatically increase annually by 2% and 3%, respectively, of the total number of issued and outstanding shares of the Company’s common stock as of December 31 of the preceding year or such lesser number as the Company’s board of directors may decide, which may be zero. Accordingly, on January 1, 2024, 17,849 additional shares of common stock became available for issuance under the 2018 Plan.

A summary of the Company’s stock option activity and related information is as follows:

 

 

 

Stock
Options

 

 

Weighted-
Average
Exercise
Price

 

 

Weighted-
Average
Remaining
Contractual
Life (Years)

 

 

Aggregate
Intrinsic
Value (in thousands)

 

Balance as of January 1, 2024

 

 

14,323

 

 

$

446.93

 

 

 

7.7

 

 

$

-

 

Granted

 

 

73,906

 

 

 

5.75

 

 

 

9.6

 

 

 

 

Exercised

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Forfeited

 

 

(3,847

)

 

 

212.95

 

 

 

 

 

 

 

Expired

 

 

(24

)

 

 

3,129.00

 

 

 

 

 

 

 

Balance as of September 30, 2024

 

 

84,358

 

 

$

70.51

 

 

 

9.2

 

 

$

-

 

Exercisable as of September 30, 2024

 

 

15,773

 

 

$

329.72

 

 

 

7.7

 

 

$

-

 

 

The weighted-average grant date fair value of stock options granted to employees and directors for the nine months ended September 30, 2024, and 2023 was $3.79 per share and $4.15 per share, respectively. The aggregate grant date fair value of stock options that vested during the nine months ended September 30, 2024, and 2023 was $452,234 and $513,718, respectively.

The intrinsic value of stock options vested and exercisable and expected to vest and become exercisable is calculated based on the difference between the exercise price and the fair value of the Company’s common stock as of September 30, 2024, and December 31, 2023. The intrinsic value of exercised stock options is the difference between the fair value of the underlying common stock and the exercise price as of the exercise date.

As of September 30, 2024, and December 31, 2023, total unrecognized compensation cost related to stock options granted to employees was $342,729 and $448,511, respectively, which is expected to be recognized over a weighted-average period of 1.54 and 2.16 years, respectively.

The grant date fair value of employee stock options was estimated using a Black-Scholes option-pricing model with the following weighted-average assumptions:

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

Expected term (in years)

 

 

6.0

 

 

 

6.0

 

Expected volatility

 

 

75

%

 

 

75

%

Risk-free interest rate

 

 

4.5

%

 

 

3.7

%

Expected dividend yield

 

 

-

%

 

 

-

%

 

 

Total stock-based compensation expense recognized in the condensed statements of operations and comprehensive loss is as follows (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Research and development

 

$

22

 

 

$

48

 

 

$

99

 

 

$

148

 

General and administrative

 

 

54

 

 

 

67

 

 

 

185

 

 

 

222

 

Total stock-based compensation expense

 

$

76

 

 

$

115

 

 

$

284

 

 

$

370

 

v3.24.3
Income Taxes
9 Months Ended
Sep. 30, 2024
Income Tax Disclosure [Abstract]  
Income Taxes

Note 13. INCOME TAXES

No provision for income taxes was recorded in either of the three-or nine-month periods ended September 30, 2024, and 2023. The Company remains in a cumulative loss position with a full valuation allowance recorded against its net deferred income tax assets as of September 30, 2024.

The Company evaluates tax positions for recognition using a more-likely-than-not recognition threshold, and those tax positions eligible for recognition are measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon the effective settlement with a taxing authority that has full knowledge of all relevant information. As of September 30, 2024, and December 31, 2023, the Company had no unrecognized income tax benefits that would affect the Company’s effective tax rate if recognized.

v3.24.3
Net Loss Per Share Attributable to Common Stockholders
9 Months Ended
Sep. 30, 2024
Earnings Per Share [Abstract]  
Net Loss Per Share Attributable to Common Stockholders

Note 14. NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS

 

The following weighted-average common stock equivalents were excluded from the calculation of diluted net loss per share for the periods presented as they had an anti-dilutive effect:

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

 

 

 

 

 

 

 

 

Options to purchase common stock

 

 

86,413

 

 

 

14,499

 

 

 

54,041

 

 

 

11,835

 

Public warrants to purchase common stock

 

 

551,553

 

 

 

-

 

 

 

640,994

 

 

 

-

 

If-converted common shares from convertible preferred stock

 

 

225,225

 

 

 

-

 

 

 

153,450

 

 

 

-

 

Private placement warrants to purchase common stock

 

 

1,149,565

 

 

 

-

 

 

 

803,043

 

 

 

-

 

v3.24.3
Segment and Geographical Information
9 Months Ended
Sep. 30, 2024
Segment Reporting [Abstract]  
Segment and Geographic Information

Note 15. SEGMENT AND GEOGRAPHIC INFORMATION

 

The Company’s chief operating decision maker, its Chief Executive Officer, reviews its operating results on an aggregate basis for purposes of allocating resources and evaluating financial performance. The Company has one business activity, the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, and there are no segment managers who are held accountable for operations or operating results. Accordingly, the Company operates in one reportable segment. As of September 30, 2024, and December 31, 2023, all long-lived assets are located in the United States.

v3.24.3
Related Party Transactions
9 Months Ended
Sep. 30, 2024
Related Party Transactions [Abstract]  
Related Party Transactions

Note 16. RELATED PARTY TRANSACTIONS

As discussed in Note 7, the Company leases its facility from 1895 Management, Ltd., a New York corporation controlled by an entity affiliated with the Company’s chairman and major stockholder of the Company. Lease expense incurred under the operating lease for each of the three-month and nine-month periods ended September 30, 2024 and 2023 was $45,144 and, $135,434, respectively.

 

On March 30, 2023, the Company entered into a Stock Purchase Agreement, pursuant to which the Company issued and sold 23,693 shares of its common stock at a purchase price of $86.10 per share for aggregate gross proceeds of $2.04 million (the "March 2023 Private Placement”). FCMI Parent Co. (“FCMI”), which is controlled by Albert D. Friedberg, the chairman of the Company’s board of directors, and Vaccinex (Rochester) L.L.C., which is majority owned and controlled by Dr. Maurice Zauderer, the Company’s President, Chief Executive Officer, and a member of the Company’s board of directors, purchased 23,229 shares of the Company's common stock for an aggregate purchase price of $2.0 million in the March 2023 Private Placement. In addition, FCMI made a binding commitment in the Stock Purchase Agreement to purchase, on or prior to May 15, 2023, up to an additional $2.96 million of shares of the Company's common stock, less the aggregate purchase price of securities of the Company other than the shares sold by the Company to investors other than FCMI and its affiliates after the closing and on or prior to May 15, 2023, and subject to the terms and conditions of the Stock Purchase Agreement.

 

On February 6, 2024, the Company entered into a securities purchase agreement pursuant to which it issued and sold 274,182 shares of our common stock together with private placement warrants to purchase up to 274,182 shares of common stock and (ii) pre-funded warrants to purchase up to 90,363 shares of common stock together with private placement warrants to purchase up to 90,363 shares of our common stock (the “February 2024 SPA”). The shares of common stock and accompanying private placement warrants were sold at a combined price of $10.15 per share and the accompanying private placement warrant, and the pre-funded warrants and accompanying private placement warrants were sold at a combined price of $10.1486 per pre-funded warrant and accompanying private

placement warrant, for aggregate gross proceeds of approximately $3.7 million. FCMI and Vaccinex (Rochester), L.L.C. purchased shares of the Company’s common stock and accompanying warrants in this transaction.

On March 27, 2024, the Company entered into a securities purchase agreement in a different form pursuant to which the Company sold 159,683 shares of common stock and warrants to purchase up to 159,683 shares of common stock in a private placement at a combined price of $7.77 per share and accompanying warrant for an aggregate purchase price of approximately $1.25 million. FCMI and Vaccinex (Rochester), L.L.C. purchased shares of the Company's common stock and accompanying warrants in this transaction. This transaction closed on March 28, 2024.

On September 17, 2024, the Company entered into the Inducement Letter Agreements as described in Note 10 above. FCMI and Vaccinex (Rochester), L.L.C. participated in the transactions contemplated by the Inducement Letter Agreements.

v3.24.3
Subsequent Events
9 Months Ended
Sep. 30, 2024
Subsequent Events [Abstract]  
Subsequent Events

Note 17. SUBSEQUENT EVENTS

On November 13, 2024, the Company entered into a securities purchase agreement pursuant to which the Company issued and sold to the purchasers named therein (the “Investors”) an aggregate of (i) 76,909 shares (“Shares”) of the Company’s common stock (“Common Stock”) at a price of $3.25 per Share and (ii) pre-funded warrants (“Pre-Funded Warrants”) to purchase up to 584,646 shares of Common Stock at a price of $3.2499 per Pre-Funded Warrant (such transaction, the “Private Placement”). The Private Placement closed on November 14, 2024 for aggregate gross proceeds to the Company of approximately $2.15 million.

The Pre-Funded Warrants have an initial exercise price of $0.0001 per share, are immediately exercisable, and may be exercised at any time until they are exercised in full, subject to a 39.99% beneficial ownership limitation provision contained therein. The Investors are FCMI Parent Co., which purchased Shares and Pre-Funded Warrants and is controlled by Albert D. Friedberg, chair of the Company’s board of directors, and Vaccinex (Rochester), L.L.C., which purchased Shares and is controlled by Maurice Zauderer, Ph.D., the Company’s president, chief executive officer and a member of the Company’s board of directors.

v3.24.3
Summary of Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
Basis of Presentation and Consolidation

Basis of Presentation and Consolidation

The accompanying unaudited condensed financial statements reflect the accounts and operations of the Company and have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information (Accounting Standards Codification (“ASC”) 270, Interim Reporting) and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, these financial statements do not include all of the information necessary for a full presentation of financial position, results of operations, and cash flows in conformity with GAAP. In the opinion of management, the condensed financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented.

These condensed financial statements should be read in conjunction with the Company’s audited financial statements and related notes included in the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2023, filed with the SEC on April 25, 2024.

Common Stock Reverse Splits

Common Stock Reverse Splits

On September 25, 2023, the Company effected a 1-for-15 reverse stock split of its issued shares of common stock. On February 19, 2024, the Company effected a second reverse split of shares of the Company's common stock on a 1-for-14 basis. All per share amounts, common shares outstanding, warrants, and stock-based compensation amounts for all periods presented have been retroactively adjusted to reflect these reverse stock splits. The shares of common stock retain a par value of $0.0001 per share.

Use of Estimates

Use of Estimates

These condensed financial statements have been prepared in conformity with U.S. GAAP. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the condensed financial statements and the reported amount of expenses during the reporting period. Such management estimates include those relating to assumptions used in the valuation of stock option awards, valuation of the warrant liabilities, valuation of the derivative asset, and valuation allowances against deferred income tax assets. Actual results could differ from those estimates.

Convertible Preferred Stock

Convertible Preferred Stock

In March 2024, the Company issued shares of a newly designated series of convertible preferred stock (see Note 9). The convertible preferred stock contained embedded redemption features requiring bifurcation and separate accounting apart from the convertible preferred stock host instrument. The Company recorded the fair value of the embedded redemption features as a derivative asset on the Company’s balance sheets in accordance with ASC Topic 815, Derivatives and Hedging. See Note 4 for the key inputs used in the fair value measurements of the derivative asset.

Fair Value of Financial Instruments

Fair Value of Financial Instruments

Financial instruments consist of cash, accounts receivable, derivative asset, accounts payable, accrued liabilities, long-term debt, warrant liabilities, and convertible preferred stock. Cash, accounts receivable, accounts payable, accrued liabilities, debt, and convertible preferred stock are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date of such amounts. Warrant liabilities and the derivative asset are measured at fair value on a recurring basis with the assumptions discussed in Note 4.

Concentration of Credit Risk, Other Risks and Uncertainties

Concentration of Credit Risk, Other Risks and Uncertainties

The Company is subject to a number of risks, including, but not limited to, the lack of available capital; the possible delisting of our common stock from Nasdaq; possible failure of preclinical testing or clinical trials; inability to obtain regulatory approval of product candidates; competitors developing new technological innovations; potential interruptions in the manufacturing and commercial supply operations; unsuccessful commercialization strategy and launch plans for its proprietary drug candidates; risks inherent in litigation, including purported class actions; market acceptance of the Company’s products; and protection of proprietary technology.

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents. Cash equivalents are deposited in interest-bearing money market accounts. Although the Company deposits its cash with multiple financial institutions, cash balances may occasionally be in excess of the amounts insured by the Federal Deposit Insurance Corporation. Management believes the financial risk associated with these balances is minimal and has not experienced any losses to date.

The Company has historically raised capital in transactions with investors that include members of its board of directors and entities controlled by certain board members. As such, the Company's directors, directly and indirectly, control a significant ownership percentage of the Company. The Company can provide no assurances that future financing will be available in sufficient amounts or on terms acceptable to it or that its directors or entities controlled by certain board members will be willing or able to participate in future capital raises by the Company.

The Company depends on third-party manufacturers for the manufacture of drug substances and drug product for clinical trials. The Company also relies on certain third parties for its supply chain. Disputes with these third- party manufacturers or shortages in goods or services from third-party suppliers could delay the manufacturing of the Company’s product candidates and adversely impact its results of operations.

Recently Issued Accounting Pronouncements

Recently Issued Accounting Pronouncements

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 requires disclosure of additional categories of information about federal, state, and foreign income taxes in the rate reconciliation table and more details about the reconciling items in some categories if items meet a quantitative threshold. The ASU requires entities to disclose income taxes paid, net of refunds, disaggregated by federal (national), state and foreign taxes for annual periods and to disaggregate the information by jurisdiction based on a quantitative threshold. The guidance makes several other changes to the disclosure requirements. The ASU is required to be applied prospectively, with the option to apply it retrospectively. The ASU is effective for fiscal years beginning after December 15, 2024. The Company is currently assessing the impact of the adoption of this guidance on its financial statements and disclosures.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. In addition, the ASU enhances interim disclosure requirements, clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, and contains other disclosure requirements. The ASU does not change how an entity identifies its operating segments, aggregates those operating segments, or applies the quantitative thresholds to determine its reportable segments. The ASU is required to be applied retrospectively to all periods presented in the financial statements. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently assessing the impact of the adoption of this guidance on its financial statements and disclosures.

v3.24.3
Balance Sheet Components (Tables)
9 Months Ended
Sep. 30, 2024
Balance Sheet Related Disclosures [Abstract]  
Property and Equipment

Property and equipment consist of the following (in thousands):

 

 

 

As of
September 30, 2024

 

 

As of
December 31, 2023

 

Leasehold improvements

 

$

3,277

 

 

$

3,277

 

Research equipment

 

 

3,373

 

 

 

3,351

 

Furniture and fixtures

 

 

350

 

 

 

350

 

Computer equipment

 

 

250

 

 

 

250

 

Property and equipment, gross

 

 

7,250

 

 

 

7,228

 

Less: accumulated depreciation and amortization

 

 

(7,168

)

 

 

(7,091

)

Property and equipment, net

 

$

82

 

 

$

136

 

Accrued Expenses

Accrued expenses consist of the following (in thousands):

 

 

 

As of
September 30, 2024

 

 

As of
December 31, 2023

 

 

 

 

 

 

 

 

Accrued clinical trial cost

 

$

649

 

 

$

853

 

Accrued payroll and related benefits

 

 

238

 

 

 

295

 

Accrued consulting and legal

 

 

204

 

 

 

58

 

Accrued other

 

 

109

 

 

 

36

 

Accrued expenses

 

$

1,200

 

 

$

1,242

 

v3.24.3
Fair Value Measurements of Financial Measurements (Tables)
9 Months Ended
Sep. 30, 2024
Fair Value Disclosures [Abstract]  
Summary of Fair Value of Financial Assets and Liabilities by Level within Fair Value Hierarchy

The following tables set forth the fair value of the Company’s financial assets and liabilities by level within the fair value hierarchy (in thousands):

 

 

 

As of September 30, 2024

 

 

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Money market fund

 

$

900

 

 

$

900

 

 

$

-

 

 

$

-

 

Derivative asset

 

 

14

 

 

 

-

 

 

 

-

 

 

 

14

 

Total Financial Assets

 

$

914

 

 

$

900

 

 

$

-

 

 

$

14

 

 

 

 

As of December 31, 2023

 

 

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Money market fund

 

$

1,337

 

 

$

1,337

 

 

$

-

 

 

$

-

 

Total Financial Assets

 

$

1,337

 

 

$

1,337

 

 

$

-

 

 

$

-

 

 

 

 

As of September 30, 2024

 

 

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liabilities - public warrants

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

Warrant liabilities - private placement warrants

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Total Financial Liabilities

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

 

 

As of December 31, 2023

 

 

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liabilities - public warrants

 

$

2,275

 

 

$

-

 

 

$

-

 

 

$

2,275

 

Warrant liabilities - private placement warrants

 

 

76

 

 

 

-

 

 

 

-

 

 

 

76

 

Total Financial Liabilities

 

$

2,351

 

 

$

-

 

 

$

-

 

 

$

2,351

 

 

Summary of Key Inputs into Valuation Models Used to Estimate Fair Value of Warrant Liabilities

The key inputs into the respective valuation models used to estimate the fair value of the warrant liabilities at September 30, 2024, were as follows:

 

 

 

 

 

 

 

 

Public Warrants

 

 

Private Placement Warrants

 

 

 

Low

 

 

High

 

 

Low

 

 

High

 

Risk-free interest rate

 

 

3.81

%

 

 

5.40

%

 

 

4.08

%

 

 

5.40

%

Volatility

 

 

83

%

 

 

130

%

 

 

83

%

 

 

130

%

Dividend yield

 

 

0

%

 

 

0

%

 

 

0

%

 

 

0

%

Expected term (years)

 

 

0.003

 

 

 

4.760

 

 

 

0.003

 

 

 

5.010

 

Share price

 

$

6.000

 

 

$

9.310

 

 

$

6.000

 

 

$

9.310

 

The key inputs into the respective valuation models used to estimate the fair value of the warrant liabilities at December 31, 2023, were as follows:

 

 

 

 

 

 

 

Public Warrants

 

 

Private Placement Warrants

 

 

 

Low

 

 

High

 

 

Low

 

 

High

 

Risk-free interest rate

 

 

3.81

%

 

 

5.42

%

 

 

3.81

%

 

 

5.33

%

Volatility

 

 

99

%

 

 

113

%

 

 

102

%

 

 

113

%

Dividend yield

 

 

0

%

 

 

0

%

 

 

0

%

 

 

0

%

Expected term (years)

 

 

0.75

 

 

 

5.01

 

 

 

0.75

 

 

 

5.01

 

Share price

 

$

9.310

 

 

$

13.160

 

 

$

9.310

 

 

$

12.880

 

Summary of Changes in Fair Value of Company's Warrant Liabilities that are Recognized in Change in Fair Value of Warrant Liabilities in Accompanying Statements of Operations and Comprehensive Loss

The following table summarizes the changes in fair value of the Company’s warrant liabilities that are recognized in the change in fair value of the warrant liabilities in the accompanying condensed statements of operations and comprehensive loss during the nine months ended September 30, 2024 (in thousands):

 

 

 

 

 

 

Public Warrants

 

 

Private Placement Warrants

 

 

Total

 

Warrant liabilities as of January 1, 2024

 

$

2,275

 

 

$

76

 

 

$

2,351

 

Issuance of warrants

 

 

-

 

 

 

1,113

 

 

 

1,113

 

Reclassified as equity

 

 

(1,199

)

 

 

(800

)

 

 

(1,999

)

Cancellation of warrants

 

 

(77

)

 

 

-

 

 

 

(77

)

Exercise of warrants

 

 

(90

)

 

 

(7

)

 

 

(97

)

Change in fair value

 

 

(909

)

 

 

(382

)

 

 

(1,291

)

Warrant liabilities as of September 30, 2024

 

$

-

 

 

$

-

 

 

$

-

 

Schedule of Quantitative Information Regarding Measurement Inputs to Estimate the Fair Value of Asset

The following table provides quantitative information regarding measurement inputs used to estimate the fair value of the Level 3 asset at:

 

 

 

September 30, 2024

 

Risk-free interest rate

 

 

5.12

%

Expected volatility

 

 

40.00

%

Expected term (in years)

 

 

0.50

 

Exercise price (per share)

 

$

7.77

 

Number of shares

 

 

10

 

Schedule of Changes in Derivative Assets

The following table presents the changes in the derivative asset during the nine months ended September 30, 2024 (in thousands):

 

 

 

 

 

Derivative asset as of January 1, 2024

 

$

-

 

Issuance of convertible preferred stock

 

 

95

 

Change in fair value

 

 

(81

)

Derivative asset as of September 30, 2024

 

$

14

 

 

v3.24.3
Common Stock Reserved For Issuance (Tables)
9 Months Ended
Sep. 30, 2024
Equity [Abstract]  
Common Stock Reserved for Potential Future Issuances

Common stock has been reserved for the following potential future issuance:

 

 

 

As of
September 30, 2024

 

 

As of
December 31, 2023

 

Shares underlying outstanding stock options

 

 

84,358

 

 

 

14,323

 

Shares available for future stock option grants

 

 

3,318

 

 

 

528

 

Shares underlying outstanding public warrants

 

 

-

 

 

 

685,714

 

Shares underlying outstanding private placement warrants

 

 

1,830,297

 

 

 

37,694

 

Shares underlying convertible preferred stock-if converted

 

 

225,225

 

 

 

-

 

Shares underlying outstanding pre-funded warrants

 

 

285,827

 

 

 

142,857

 

Total shares of common stock reserved

 

 

2,429,025

 

 

 

881,116

 

v3.24.3
Stock-Based Compensation (Tables)
9 Months Ended
Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]  
Summary of Stock Option Activity and Related Information

A summary of the Company’s stock option activity and related information is as follows:

 

 

 

Stock
Options

 

 

Weighted-
Average
Exercise
Price

 

 

Weighted-
Average
Remaining
Contractual
Life (Years)

 

 

Aggregate
Intrinsic
Value (in thousands)

 

Balance as of January 1, 2024

 

 

14,323

 

 

$

446.93

 

 

 

7.7

 

 

$

-

 

Granted

 

 

73,906

 

 

 

5.75

 

 

 

9.6

 

 

 

 

Exercised

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Forfeited

 

 

(3,847

)

 

 

212.95

 

 

 

 

 

 

 

Expired

 

 

(24

)

 

 

3,129.00

 

 

 

 

 

 

 

Balance as of September 30, 2024

 

 

84,358

 

 

$

70.51

 

 

 

9.2

 

 

$

-

 

Exercisable as of September 30, 2024

 

 

15,773

 

 

$

329.72

 

 

 

7.7

 

 

$

-

 

Grant Date Fair Value of Employee Stock Options Estimated Using Black-Scholes Option-Pricing Model with Weighted-Average Assumptions

The grant date fair value of employee stock options was estimated using a Black-Scholes option-pricing model with the following weighted-average assumptions:

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

Expected term (in years)

 

 

6.0

 

 

 

6.0

 

Expected volatility

 

 

75

%

 

 

75

%

Risk-free interest rate

 

 

4.5

%

 

 

3.7

%

Expected dividend yield

 

 

-

%

 

 

-

%

Total Stock-Based Compensation Expense Recognized in Condensed Statements of Operations and Comprehensive Loss

Total stock-based compensation expense recognized in the condensed statements of operations and comprehensive loss is as follows (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Research and development

 

$

22

 

 

$

48

 

 

$

99

 

 

$

148

 

General and administrative

 

 

54

 

 

 

67

 

 

 

185

 

 

 

222

 

Total stock-based compensation expense

 

$

76

 

 

$

115

 

 

$

284

 

 

$

370

 

v3.24.3
Net Loss Per Share Attributable to Common Stockholders (Tables)
9 Months Ended
Sep. 30, 2024
Earnings Per Share [Abstract]  
Weighted-Average Common Stock Equivalents Excluded from Calculation of Diluted Net Loss Per Share as They Had Anti-Dilutive Effect

The following weighted-average common stock equivalents were excluded from the calculation of diluted net loss per share for the periods presented as they had an anti-dilutive effect:

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

 

 

 

 

 

 

 

 

Options to purchase common stock

 

 

86,413

 

 

 

14,499

 

 

 

54,041

 

 

 

11,835

 

Public warrants to purchase common stock

 

 

551,553

 

 

 

-

 

 

 

640,994

 

 

 

-

 

If-converted common shares from convertible preferred stock

 

 

225,225

 

 

 

-

 

 

 

153,450

 

 

 

-

 

Private placement warrants to purchase common stock

 

 

1,149,565

 

 

 

-

 

 

 

803,043

 

 

 

-

 

v3.24.3
Company and Nature of Business - Additional Information (Details) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Organization Consolidation And Presentation Of Financial Statements [Line Items]      
Cash used in operations $ (12,254) $ (13,642)  
Accumulated deficit $ 355,187   $ 339,927
v3.24.3
Summary of Significant Accounting Policies - Additional Information (Details)
9 Months Ended
Feb. 19, 2024
$ / shares
Sep. 25, 2023
$ / shares
Sep. 30, 2024
$ / shares
Dec. 31, 2023
$ / shares
Accounting Policies [Abstract]        
Reverse stock splits description     Company effected a 1-for-15 reverse stock split of its issued shares of common stock. On February 19, 2024, the Company effected a second reverse split of shares of the Company's common stock on a 1-for-14 basis. All per share amounts, common shares outstanding, warrants, and stock-based compensation amounts for all periods presented have been retroactively adjusted to reflect these reverse stock splits.  
Stock split, conversion ratio 0.14 0.15    
Common stock, par value $ 0.0001 $ 0.0001 $ 0.0001 $ 0.0001
v3.24.3
Balance Sheet Components - Property and Equipment (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Property Plant And Equipment [Line Items]    
Property and equipment, gross $ 7,250 $ 7,228
Less: accumulated depreciation and amortization (7,168) (7,091)
Property and equipment, net 82 136
Leasehold Improvements    
Property Plant And Equipment [Line Items]    
Property and equipment, gross 3,277 3,277
Research Equipment    
Property Plant And Equipment [Line Items]    
Property and equipment, gross 3,373 3,351
Furniture and Fixtures    
Property Plant And Equipment [Line Items]    
Property and equipment, gross 350 350
Computer Equipment    
Property Plant And Equipment [Line Items]    
Property and equipment, gross $ 250 $ 250
v3.24.3
Balance Sheet Components - Additional Information (Details) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Property, Plant and Equipment [Abstract]        
Depreciation $ 24,000 $ 31,000 $ 77,000 $ 92,500
v3.24.3
Balance Sheet Components - Schedule of Accrued Expenses (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Payables and Accruals [Abstract]    
Accrued clinical trial cost $ 649 $ 853
Accrued payroll and related benefits 238 295
Accrued consulting and legal 204 58
Accrued other 109 36
Accrued expenses $ 1,200 $ 1,242
v3.24.3
Fair Value Measurements of Financial Measurements - Summary of Fair Value of Financial Assets and Liabilities by Level within Fair Value Hierarchy (Details) - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Financial Assets:    
Derivative asset $ 14  
Financial Liabilities:    
Warrant liabilities 0 $ 2,351,000
Public Warrants    
Financial Liabilities:    
Warrant liabilities 0 2,275,000
Private Placement Warrants    
Financial Liabilities:    
Warrant liabilities 0 76,000
Fair Value Measurements Recurring    
Financial Assets:    
Derivative asset 14,000  
Total Financial Assets 914,000 1,337,000
Financial Liabilities:    
Total Financial Liabilities 0 2,351,000
Fair Value Measurements Recurring | Public Warrants    
Financial Liabilities:    
Warrant liabilities 0 2,275,000
Fair Value Measurements Recurring | Private Placement Warrants    
Financial Liabilities:    
Warrant liabilities 0 76,000
Fair Value Measurements Recurring | Money Market Funds    
Financial Assets:    
Cash equivalents 900,000 1,337,000
Fair Value Measurements Recurring | Level 1    
Financial Assets:    
Total Financial Assets 900,000 1,337,000
Fair Value Measurements Recurring | Level 1 | Money Market Funds    
Financial Assets:    
Cash equivalents 900,000 1,337,000
Fair Value Measurements Recurring | Level 3    
Financial Assets:    
Derivative asset 14,000  
Total Financial Assets 14,000  
Financial Liabilities:    
Total Financial Liabilities 0 2,351,000
Fair Value Measurements Recurring | Level 3 | Public Warrants    
Financial Liabilities:    
Warrant liabilities 0 2,275,000
Fair Value Measurements Recurring | Level 3 | Private Placement Warrants    
Financial Liabilities:    
Warrant liabilities $ 0 $ 76,000
v3.24.3
Fair Value Measurements of Financial Measurements - Additional Information (Details) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]        
Warrant liabilities $ 0 $ 0 $ 0 $ 2,351,000
Change in fair value of warrant liabilities 71,000 (1,291,000) 0  
Fair Value Measurements Recurring        
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]        
Financial assets, level 1 to level 2 transfer, amount 0 0 0  
Financial assets, level 2 to level 1 transfer, amount 0 0 0  
Financial assets, transfer in to level 3, amount   0 0  
Financial assets, transfer out of level 3, amount   0 0  
Financial liabilities, level 1 to level 2 transfer, amount 0 0 0  
Financial liabilities, level 2 to level 1 transfer, amount $ 0 0 0  
Financial liabilities, transfer in to level 3, amount   0 0  
Financial liabilities, transfer out of level 3, amount   $ 0 $ 0  
v3.24.3
Fair Value Measurements of Financial Measurements - Summary of Key Inputs in to Valuation Models Used to Estimate Fair Value of Warrant Liabilities (Details)
Sep. 30, 2024
Dec. 31, 2023
Public Warrants | Maximum | Risk-Free Interest Rate    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 5.4 5.42
Public Warrants | Maximum | Volatility    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 130 113
Public Warrants | Maximum | Dividend Yield    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 0 0
Public Warrants | Maximum | Expected Term (Years)    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 4.76 5.01
Public Warrants | Maximum | Share Price    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 9.31 13.16
Public Warrants | Minimum | Risk-Free Interest Rate    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 3.81 3.81
Public Warrants | Minimum | Volatility    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 83 99
Public Warrants | Minimum | Dividend Yield    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 0 0
Public Warrants | Minimum | Expected Term (Years)    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 0.003 0.75
Public Warrants | Minimum | Share Price    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 6 9.31
Private Placement Warrants | Maximum | Risk-Free Interest Rate    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 5.4 5.33
Private Placement Warrants | Maximum | Volatility    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 130 113
Private Placement Warrants | Maximum | Dividend Yield    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 0 0
Private Placement Warrants | Maximum | Expected Term (Years)    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 5.01 5.01
Private Placement Warrants | Maximum | Share Price    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 9.31 12.88
Private Placement Warrants | Minimum | Risk-Free Interest Rate    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 4.08 3.81
Private Placement Warrants | Minimum | Volatility    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 83 102
Private Placement Warrants | Minimum | Dividend Yield    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 0 0
Private Placement Warrants | Minimum | Expected Term (Years)    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 0.003 0.75
Private Placement Warrants | Minimum | Share Price    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Warrant liabilities measurement input 6 9.31
v3.24.3
Fair Value Measurements of Financial Measurements - Summary of Changes in Fair Value of Company's Warrant Liabilities that are Recognized in Change in Fair Value of Warrant Liabilities in Accompanying Statements of Operations and Comprehensive Loss (Details) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2024
Sep. 30, 2023
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Warrant liabilities as of January 1, 2024   $ 2,351,000  
Issuance of warrants   1,113,000  
Reclassified as equity   (1,999,000)  
Cancellation of warrants   (77,000)  
Exercise of warrants   (97,000)  
Change in fair value $ 71,000 (1,291,000) $ 0
Warrant liabilities as of September 30, 2024 0 0  
Public Warrants      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Warrant liabilities as of January 1, 2024   2,275,000  
Reclassified as equity   (1,199,000)  
Cancellation of warrants   (77,000)  
Exercise of warrants   (90,000)  
Change in fair value   (909,000)  
Warrant liabilities as of September 30, 2024 0 0  
Private Placement Warrants      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Warrant liabilities as of January 1, 2024   76,000  
Issuance of warrants   1,113,000  
Reclassified as equity   (800,000)  
Exercise of warrants   (7,000)  
Change in fair value   (382,000)  
Warrant liabilities as of September 30, 2024 $ 0 $ 0  
v3.24.3
Fair Value Measurements of Financial Measurements - Schedule of Quantitative Information Regarding Measurement Inputs to Estimate the Fair Value of Asset (Details) - Level 3
Sep. 30, 2024
Risk-Free Interest Rate  
Fair Value Measurement Inputs and Valuation Techniques [Line Items]  
Derivative asset measurement input 5.12
Expected Volatility  
Fair Value Measurement Inputs and Valuation Techniques [Line Items]  
Derivative asset measurement input 40
Expected Term (in years)  
Fair Value Measurement Inputs and Valuation Techniques [Line Items]  
Derivative asset measurement input 0.5
Exercise Price (per share)  
Fair Value Measurement Inputs and Valuation Techniques [Line Items]  
Derivative asset measurement input 7.77
Number of shares  
Fair Value Measurement Inputs and Valuation Techniques [Line Items]  
Derivative asset measurement input 10
v3.24.3
Fair Value Measurements of Financial Measurements - Schedule of Changes in Derivative Assets (Details)
9 Months Ended
Sep. 30, 2024
USD ($)
Fair Value Disclosures [Abstract]  
Change in fair value $ (81)
Issuance of convertible preferred stock 95
Derivative assets ending balance $ 14
v3.24.3
Collaboration Agreements - Additional Information (Details)
1 Months Ended 3 Months Ended 9 Months Ended
Nov. 30, 2017
USD ($)
Milestone
TargetAntigen
Sep. 30, 2024
USD ($)
Sep. 30, 2023
USD ($)
Sep. 30, 2024
USD ($)
Sep. 30, 2023
USD ($)
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]          
Number of target antigens against which antibodies are to be identified and selected | TargetAntigen 2        
Revenue   $ 52,000 $ 20,000 $ 388,000 $ 570,000
Surface Oncology, Inc.          
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]          
Upfront payments fee received $ 250,000        
Number of designated milestones | Milestone 4        
Surface Oncology, Inc. | Exclusive Product License          
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]          
Revenue         $ 500,000
v3.24.3
Commitments and Contingencies - Additional Information (Details) - USD ($)
Apr. 11, 2024
Sep. 30, 2024
Jun. 30, 2024
Mar. 31, 2024
Dec. 31, 2023
Sep. 30, 2023
Jun. 30, 2023
Mar. 31, 2023
Dec. 31, 2022
Commitments And Contingencies [Line Items]                  
Minimum stockholders' equity required for listing $ 2,500,000                
Market value of listed securities 35,000,000                
Net income from continuing operations related to listing $ 500,000                
Stockholder's deficit   $ 1,321,000 $ 2,864,000 $ (2,655,000) $ 2,311,000 $ 3,869,000 $ 423,000 $ (2,400,000) $ (5,193,000)
Percentage of cancelled warrants in outstanding shares   8.00%              
v3.24.3
Leases - Additional Information (Details) - USD ($)
3 Months Ended 9 Months Ended 14 Months Ended 27 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Oct. 31, 2025
Oct. 31, 2024
Lessee Lease Description [Line Items]            
Lessee operating lease, incremental borrowing rate 7.00%   7.00%      
Lessee, operating lease, discount rate, description     The leases do not provide an implicit rate so in determining the present value of lease payments, the Company uses its incremental borrowing rate for the applicable lease, which was 7.0%.      
Future minimum operating leases payment in total $ 15,048   $ 15,048      
Imputed interest 87   87      
Operating lease liability 14,961   14,961      
Cash paid for amount included in measurement of lease liabilities     90,290 $ 135,434    
Lease expense incurred under operating lease $ 45,144 $ 45,144 $ 135,434 $ 135,434    
Subsequent Event            
Lessee Lease Description [Line Items]            
Monthly rental payments           $ 15,048
Forecast            
Lessee Lease Description [Line Items]            
Periodic rental payments         $ 180,578  
v3.24.3
Long-term Debt - Additional Information (Details) - PPP Loan - USD ($)
3 Months Ended 9 Months Ended
Nov. 08, 2021
May 08, 2020
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Debt Instrument [Line Items]            
Interest expense     $ 141 $ 336 $ 585 $ 1,141
Amount of loan received   $ 1,133,600        
Maturity date May 08, 2025 May 08, 2022        
Debt instrument interest rate 1.00% 1.00%        
Payments commencement date   Nov. 08, 2020        
CARES Act of 2020 aid forgiveness amount $ 876,171          
Monthly repayment $ 6,334          
v3.24.3
Convertible Preferred Stock - Additional Information (Details)
9 Months Ended
Mar. 28, 2024
USD ($)
PercentagePoint
PValue
$ / shares
shares
Sep. 30, 2024
USD ($)
Dec. 31, 2023
USD ($)
Class of Stock [Line Items]      
Accounts receivable   $ 985,000 $ 961,000
Liquidation value   1,750,000,000 $ 0
Derivative asset   14  
Proceeds from issuance of preferred stock and warrants   $ 1,697,000  
ADDF Warrant      
Class of Stock [Line Items]      
Warrant expiration date   Mar. 29, 2029  
Proceeds from issuance of warrants   $ 570,000  
Securities Purchase Agreement      
Class of Stock [Line Items]      
Maximum common stock purchased | shares 229,057    
Aggregate purchase price of common stock $ 1,750,000    
Conversion price | $ / shares $ 7.77    
Minimum limit of borrowings $ 1,000,000    
Series A Preferred Stock      
Class of Stock [Line Items]      
Conversion price | $ / shares $ 7.77    
Proceeds from issuance of convertible preferred stock   1,180,000  
Preferred stock liquidation asset value $ 175,000 175,000  
Liquidation value   1,750,000  
Derivative asset $ 95,000 $ 95,000  
Series A Preferred Stock | Securities Purchase Agreement      
Class of Stock [Line Items]      
Preferred stock, voting rights The Series A Preferred Stock is non-voting, has no mandatory redemption    
Preferred stock, dividend rate 5.00%    
Increase in dividend percentage points per year | PercentagePoint 2    
Maximum limit dividend rate can increase 12.00%    
Preferred stock, a liquidation preference | $ / shares $ 175,000    
Percentage of share holders consent required to amend bylaws 50.10%    
Series A Preferred Stock | Securities Purchase Agreement | Maximum      
Class of Stock [Line Items]      
Statistical significance of p-value | PValue 0.05    
v3.24.3
Warrants - Additional Information (Details)
1 Months Ended 3 Months Ended 9 Months Ended
Nov. 13, 2024
Sep. 17, 2024
USD ($)
$ / shares
shares
Jul. 18, 2024
shares
Mar. 28, 2024
USD ($)
PValue
Mar. 27, 2024
$ / shares
shares
Feb. 06, 2024
USD ($)
TradingDay
$ / shares
shares
Oct. 03, 2023
USD ($)
PValue
TradingDay
$ / shares
shares
Mar. 30, 2023
Feb. 29, 2024
USD ($)
$ / shares
shares
Nov. 30, 2023
shares
Sep. 30, 2024
USD ($)
$ / shares
shares
Mar. 31, 2024
USD ($)
shares
Sep. 30, 2024
USD ($)
$ / shares
shares
Sep. 30, 2023
USD ($)
Feb. 19, 2024
$ / shares
Dec. 31, 2023
$ / shares
shares
Sep. 25, 2023
$ / shares
Class of Warrant or Right [Line Items]                                  
Sale of stock, transaction date               Mar. 27, 2024                  
Proceeds from issuance of common stock | $                           $ 1,268,000      
Derivative asset | $                     $ 14   $ 14        
Change in fair value of warrant liability | $                     $ 71,000   $ (1,291,000) $ 0      
Reclassification of public warrants, as amended | $                       $ 1,199,000          
Description of public warrants right to call                         The Company had the right to “call” any portion of a holder’s public warrants by delivering a call notice to the holder within 30 days after the Company publicly announced an increase in pepinemab-treated patients relative to placebo-treated patients, with statistical significance having a p-value of less than or equal to 0.05, in the change of the FDG-PET standard uptake value ratio for brain metabolism between baseline and month 12 as assessed by [18F]fluorodeoxyglucose (FDG)-PET in the resting state following administration of 40 mg/kg pepinemab or placebo, as applicable, as described in the protocol for the Company’s SIGNAL-AD Alzheimer’s disease study and the associated Statistical Analysis Plan (the “Positive Data Release”). After delivery of a call notice, the public warrants would continue to be exercisable. Each public warrant would be canceled and no longer exercisable to the extent the holder failed to timely exercise the public warrant for the called portion thereof within 20 trading days following the Company’s issuance of a call notice.        
Common stock, par value | $ / shares                     $ 0.0001   $ 0.0001   $ 0.0001 $ 0.0001 $ 0.0001
Common stock, shares issued                     2,599,733   2,599,733     892,622  
Series A Preferred Stock                                  
Class of Warrant or Right [Line Items]                                  
Derivative asset | $       $ 95,000             $ 95,000   $ 95,000        
Securities Purchase Agreement                                  
Class of Warrant or Right [Line Items]                                  
Sale of stock, transaction date Nov. 13, 2024                                
Shares issued, price per share | $ / shares                     $ 7.64   $ 7.64        
November Warrant Offering                                  
Class of Warrant or Right [Line Items]                                  
Warrants issued                       354,693          
February 2024 Private Placement                                  
Class of Warrant or Right [Line Items]                                  
Sale of stock, transaction date           Feb. 06, 2024                      
Warrants issued                       354,693          
Proceeds from issuance of common stock | $           $ 3,700,000                      
Public Offering and Private Placement                                  
Class of Warrant or Right [Line Items]                                  
Shares issued, price per share | $ / shares         $ 7.77                        
Maximum [Member] | Securities Purchase Agreement | Series A Preferred Stock                                  
Class of Warrant or Right [Line Items]                                  
Statistical significance of p-value | PValue       0.05                          
Common Stock                                  
Class of Warrant or Right [Line Items]                                  
Number of shares sold         159,683                        
Common Stock | Private Placement                                  
Class of Warrant or Right [Line Items]                                  
Warrants issued         159,683                        
Common Stock | Public Offering and Private Placement                                  
Class of Warrant or Right [Line Items]                                  
Shares issued, price per share | $ / shares         $ 7.77                        
Public Warrants                                  
Class of Warrant or Right [Line Items]                                  
Sale of stock, transaction date             Oct. 03, 2023                    
Warrants expiration period             5 years                    
Call notice period             30 days                    
Number of trading days | TradingDay             20                    
Issuance date fair value | $             $ 3,500,000                    
Percentage of public warrants issued with holders                       83.00%          
Change in fair value of warrant liability | $                         $ 700,000        
Warrants outstanding                     0   0        
Public Warrants | Maximum [Member]                                  
Class of Warrant or Right [Line Items]                                  
Statistical significance of p-value | PValue             0.05                    
Public Warrants | Common Stock                                  
Class of Warrant or Right [Line Items]                                  
Number of shares sold         193,000   542,857                    
Warrants issued             542,857                    
Shares issued, price per share | $ / shares             $ 14                    
Notice period to change beneficial ownership limitation             61 days                    
Maximum beneficial ownership limitation             9.99%                    
Public Warrants | Warrants Reclassified As Equity                                  
Class of Warrant or Right [Line Items]                                  
Reclassification of public warrants, as amended | $                         $ 1,200,000        
Pre Funded Warrants and Public Warrants                                  
Class of Warrant or Right [Line Items]                                  
Shares issued, price per share | $ / shares             $ 13.986                    
Proceeds from issuance of common stock | $             $ 9,600,000                    
Pre Funded Warrants and Public Warrants | Common Stock                                  
Class of Warrant or Right [Line Items]                                  
Warrants issued             142,857                    
Pre-funded Warrants                                  
Class of Warrant or Right [Line Items]                                  
Proceeds from issuance of common stock | $                 $ 900,000                
Pre-funded Warrants | Common Stock                                  
Class of Warrant or Right [Line Items]                                  
Number of shares sold                 90,363                
Warrants issued             142,857                    
Shares issued, price per share | $ / shares                 $ 0.0014                
Warrants exercised     142,857                            
Private Placement Warrants                                  
Class of Warrant or Right [Line Items]                                  
Warrants expiration period                   5 years              
Proceeds from issuance of common stock | $                         $ 840,000        
Description of warrants right to call                         The Company had the right to “call” the exercise of any portion of a holder’s private placement warrants by delivering a call notice to the holder within 30 days, in the case of the November private placement warrants, or 120 days in the case of the February private placement warrants, after the Positive Data Release. After delivery of a call notice, the private placement warrants will continue to be exercisable. Each private placement warrant would be canceled and no longer exercisable to the extent the holder failed to timely exercise the private placement warrant for the called portion thereof within 20 trading days, in the case of the November private placement warrants, or 30 trading days in the case of the February private placement warrants, following the Company’s issuance of a call notice, provided that to the extent the exercise of a called portion of a private placement warrant would cause the holder to hold common stock in excess of a specified beneficial ownership limitation, upon exercise of such portion, as set forth in the private placement warrant, instead of shares being issued, the exercise would result in the modification of the terms of such portion to be consistent with the terms of the pre-funded warrant.        
Change in fair value of warrant liability | $                         $ 360,000        
Reclassification of public warrants, as amended | $                         $ 800,000        
Warrants outstanding                     0   0        
Private Placement Warrants | November Warrant Offering                                  
Class of Warrant or Right [Line Items]                                  
Call notice period             30 days                    
Number of trading days | TradingDay           20                      
Percentage of warrants issued with holders                       100.00%          
Private Placement Warrants | February 2024 Private Placement                                  
Class of Warrant or Right [Line Items]                                  
Call notice period           120 days                      
Number of trading days | TradingDay           30                      
Percentage of warrants issued with holders                       97.00%          
Private Placement Warrants | Common Stock | November Warrant Offering                                  
Class of Warrant or Right [Line Items]                                  
Number of shares sold                   37,694              
Private Placement Warrants | Common Stock | February 2024 Private Placement                                  
Class of Warrant or Right [Line Items]                                  
Number of shares sold           274,182                      
Shares issued, price per share | $ / shares           $ 10.15                      
Common Warrants | February 2024 Private Placement                                  
Class of Warrant or Right [Line Items]                                  
Exercise price of warrants | $ / shares           $ 14                      
Common Warrants | Common Stock | February 2024 Private Placement                                  
Class of Warrant or Right [Line Items]                                  
Warrants issued           274,182                      
Common Warrants | Common Stock | Private Placement                                  
Class of Warrant or Right [Line Items]                                  
Warrants issued         193,000                        
Common and Pre-Funded Warrants | February 2024 Private Placement                                  
Class of Warrant or Right [Line Items]                                  
Warrants issued           90,363                      
Shares issued, price per share | $ / shares           $ 10.1486                      
ADDF Warrant                                  
Class of Warrant or Right [Line Items]                                  
Warrant expiration date                     Mar. 29, 2029   Mar. 29, 2029        
ADDF Warrant | Common Stock                                  
Class of Warrant or Right [Line Items]                                  
Number of shares sold                         229,057        
Existing Warrants | Inducement Letter Agreements                                  
Class of Warrant or Right [Line Items]                                  
Exercise price of warrants | $ / shares   $ 5.636                              
Change in fair value of warrant liability | $   $ 200,000                              
Common stock, par value | $ / shares   $ 0.0001                              
Common stock, shares issued   872,028                              
Pre-funding of common stock shares   195,464                              
Existing Warrants | Common Stock | Inducement Letter Agreements                                  
Class of Warrant or Right [Line Items]                                  
Warrants issued   1,067,492                              
New Warrants | Inducement Letter Agreements                                  
Class of Warrant or Right [Line Items]                                  
Exercise price of warrants | $ / shares   $ 5.636                              
Warrant expiration date                     Sep. 18, 2029   Sep. 18, 2029        
New Warrants | Private Placement | Inducement Letter Agreements                                  
Class of Warrant or Right [Line Items]                                  
Shares issued, price per share | $ / shares   $ 0.125                              
New Warrants | Common Stock | Inducement Letter Agreements                                  
Class of Warrant or Right [Line Items]                                  
Warrants issued   1,601,238                              
Existing and New Warrants | Inducement Letter Agreements                                  
Class of Warrant or Right [Line Items]                                  
Gross proceeds from exercise and sale of warrants | $   $ 6,200,000                              
v3.24.3
Common Stock Reserved For Issuance - Common Stock Reserved For Potential Future Issuances (Details) - shares
Sep. 30, 2024
Dec. 31, 2023
Class Of Stock [Line Items]    
Total shares of common stock reserved 2,429,025 881,116
Shares Underlying Outstanding Stock Options    
Class Of Stock [Line Items]    
Total shares of common stock reserved 84,358 14,323
Shares Available For Future Stock Option Grants    
Class Of Stock [Line Items]    
Total shares of common stock reserved 3,318 528
Shares Underlying Outstanding Public Warrants    
Class Of Stock [Line Items]    
Total shares of common stock reserved   685,714
Shares Underlying Outstanding Private Placement Warrants    
Class Of Stock [Line Items]    
Total shares of common stock reserved 1,830,297 37,694
Shares Underlying Convertible Preferred Stock-if Converted    
Class Of Stock [Line Items]    
Total shares of common stock reserved 225,225  
Shares Underlying Outstanding Pre-funded Warrants    
Class Of Stock [Line Items]    
Total shares of common stock reserved 285,827 142,857
v3.24.3
Stock-Based Compensation - Additional Information (Details) - USD ($)
9 Months Ended 12 Months Ended
May 09, 2024
Jan. 01, 2024
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]          
Total shares of common stock reserved     2,429,025   881,116
Weighted-average grant date fair value of stock options granted to employees and directors     $ 3.79 $ 4.15  
Aggregate grant date fair value of stock options vested     $ 452,234 $ 513,718  
Total unrecognized compensation cost related to stock options granted to employees     $ 342,729   $ 448,511
2018 Omnibus Incentive Plan          
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]          
Total shares of common stock reserved     2,024    
Percentage of total shares of common stock reserved 4.50% 2.00% 3.00%    
Additional shares of common stock 55,422 17,849      
2018 Omnibus Incentive Plan | Minimum          
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]          
Percentage of voting power of all classes of stock to be owned by optionee to determine the exercise price     10.00%    
Exercise price as a percentage of fair value of common stock on grant date if optionee owns stock representing more than 10 percent of voting power of all classes of stock     110.00%    
Employee Stock Options          
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]          
Total unrecognized compensation cost related to stock options granted to employees, weighted-average recognition period     1 year 6 months 14 days   2 years 1 month 28 days
Employee Stock Options | 2011 Employee Equity Plan | Maximum          
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]          
Stock options granted, expiration year     10 years    
Employee Stock Options | 2018 Omnibus Incentive Plan | Maximum          
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]          
Stock options granted, expiration year     10 years    
Employee Stock Options | 2018 Omnibus Incentive Plan | Maximum | Board of Directors          
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]          
Vesting period of stock option grants     8 years    
v3.24.3
Stock-Based Compensation - Summary of Stock Option Activity and Related Information (Details) - USD ($)
$ / shares in Units, $ in Thousands
9 Months Ended 12 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Share-Based Payment Arrangement [Abstract]    
Stock Options, Balance 14,323  
Stock Options, Granted 73,906  
Stock Options, Forfeited (3,847)  
Stock Options, Expired (24)  
Stock Options, Balance 84,358 14,323
Stock Options, Exercisable 15,773  
Weighted-Average Exercise Price, Balance $ 446.93  
Weighted-Average Exercise Price, Granted 5.75  
Weighted-Average Exercise Price, Forfeited 212.95  
Weighted-Average Exercise Price, Expired 3,129  
Weighted-Average Exercise Price, Balance 70.51 $ 446.93
Weighted-Average Exercise Price, Exercisable $ 329.72  
Weighted-Average Remaining Contractual Life (Years), Balance 9 years 2 months 12 days 7 years 8 months 12 days
Weighted-Average Remaining Contractual Life (Years), Granted 9 years 7 months 6 days  
Weighted-Average Remaining Contractual Life (Years), Exercisable 7 years 8 months 12 days  
Aggregate Intrinsic Value, Balance $ 0  
Aggregate Intrinsic Value, Exercisable $ 0  
v3.24.3
Stock-Based Compensation - Grant Date Fair Value of Employee Stock Options Estimated Using Black-Scholes Option-Pricing Model with Weighted-Average Assumptions (Details) - Employee Stock Options
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Expected term (in years) 6 years 6 years
Expected volatility 75.00% 75.00%
Risk-free interest rate 4.50% 3.70%
v3.24.3
Stock-Based Compensation - Total Stock-Based Compensation Expense Recognized in Condensed Statements of Operations and Comprehensive Loss (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]        
Total stock-based compensation expense $ 76 $ 115 $ 284 $ 370
Research and Development        
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]        
Total stock-based compensation expense 22 48 99 148
General and Administrative        
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]        
Total stock-based compensation expense $ 54 $ 67 $ 185 $ 222
v3.24.3
Income Taxes - Additional Information (Details) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Income Tax Disclosure [Abstract]          
Provision for income taxes $ 0 $ 0 $ 0 $ 0  
Unrecognized tax benefits that would impact effective tax rate $ 0   $ 0   $ 0
v3.24.3
Net Loss Per Share Attributable to Common Stockholders - Weighted-Average Common Stock Equivalents Excluded from Calculation of Diluted Net Loss Per Share as They Had Anti-Dilutive Effect (Details) - shares
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Public Warrants        
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]        
Weighted-average common stock equivalents excluded from calculation of diluted net loss per share 551,553   640,994  
If Converted Common Shares From Convertible Preferred Stock        
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]        
Weighted-average common stock equivalents excluded from calculation of diluted net loss per share 225,225   153,450  
Private Placement Warrants        
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]        
Weighted-average common stock equivalents excluded from calculation of diluted net loss per share 1,149,565   803,043  
Employee Stock Options        
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]        
Weighted-average common stock equivalents excluded from calculation of diluted net loss per share 86,413 14,499 54,041 11,835
v3.24.3
Segment and Geographic Information - Additional Information (Details)
9 Months Ended 12 Months Ended
Sep. 30, 2024
Segment
SegmentManager
BusinessActivity
Dec. 31, 2023
Segment
Segment Reporting Information [Line Items]    
Number of business activity | BusinessActivity 1  
Number of segment managers held accountable for operations or operating results | SegmentManager 0  
United States    
Segment Reporting Information [Line Items]    
Number of reportable segments | Segment 1 1
v3.24.3
Related Party Transactions - Additional Information (Details) - USD ($)
3 Months Ended 9 Months Ended
Mar. 27, 2024
Feb. 06, 2024
Oct. 03, 2023
May 15, 2023
Mar. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Mar. 31, 2024
Dec. 31, 2023
Related Party Transaction [Line Items]                      
Lease expense incurred under operating lease           $ 45,144 $ 45,144 $ 135,434 $ 135,434    
Sale of stock, transaction date         Mar. 27, 2024            
Gross proceeds from issuance of common stock                 $ 1,268,000    
Common stock, shares issued           2,599,733   2,599,733     892,622
Public Warrants                      
Related Party Transaction [Line Items]                      
Sale of stock, transaction date     Oct. 03, 2023                
Private Placement Warrants                      
Related Party Transaction [Line Items]                      
Gross proceeds from issuance of common stock               $ 840,000      
March 2023 Private Placement                      
Related Party Transaction [Line Items]                      
Sale of stock, transaction date         Mar. 30, 2023            
March 2023 Private Placement | FCMI Parent Co.                      
Related Party Transaction [Line Items]                      
Gross proceeds from issuance of common stock         $ 2,000,000            
Common stock, shares issued         23,229            
March 2023 Private Placement | Vaccinex (Rochester) L.L.C.                      
Related Party Transaction [Line Items]                      
Gross proceeds from issuance of common stock         $ 2,000,000            
Common stock, shares issued         23,229            
Public Offering and Private Placement                      
Related Party Transaction [Line Items]                      
Aggregate purchase price $ 1,250,000                    
Shares issued, price per share $ 7.77                    
February 2024 Private Placement                      
Related Party Transaction [Line Items]                      
Sale of stock, transaction date   Feb. 06, 2024                  
Warrants issued                   354,693  
Gross proceeds from issuance of common stock   $ 3,700,000                  
February 2024 Private Placement | Common and Pre-Funded Warrants                      
Related Party Transaction [Line Items]                      
Warrants issued   90,363                  
Shares issued, price per share   $ 10.1486                  
Common Stock                      
Related Party Transaction [Line Items]                      
Aggregate number of shares issued and sell 159,683                    
Common Stock | Public Warrants                      
Related Party Transaction [Line Items]                      
Aggregate number of shares issued and sell 193,000   542,857                
Warrants issued     542,857                
Shares issued, price per share     $ 14                
Common Stock | Private Placement                      
Related Party Transaction [Line Items]                      
Warrants issued 159,683                    
Common Stock | Private Placement | Common Warrants                      
Related Party Transaction [Line Items]                      
Warrants issued 193,000                    
Common Stock | March 2023 Private Placement                      
Related Party Transaction [Line Items]                      
Aggregate number of shares issued and sell         23,693            
Shares issued, price per share         $ 86.1            
Gross proceeds from issuance of common stock         $ 2,040,000.00            
Common Stock | May 2023 Private Placement                      
Related Party Transaction [Line Items]                      
Gross proceeds from issuance of common stock       $ 2,960,000              
Common Stock | Public Offering and Private Placement                      
Related Party Transaction [Line Items]                      
Aggregate purchase price $ 1,500,000                    
Shares issued, price per share $ 7.77                    
Common Stock | February 2024 Private Placement | Common Warrants                      
Related Party Transaction [Line Items]                      
Warrants issued   274,182                  
Common Stock | February 2024 Private Placement | Private Placement Warrants                      
Related Party Transaction [Line Items]                      
Aggregate number of shares issued and sell   274,182                  
Shares issued, price per share   $ 10.15                  
v3.24.3
Subsequent Events - Additonal Information (Details) - USD ($)
$ / shares in Units, $ in Thousands
1 Months Ended 9 Months Ended
Nov. 14, 2024
Nov. 13, 2024
Mar. 27, 2024
Mar. 30, 2023
Feb. 29, 2024
Sep. 30, 2023
Sep. 30, 2024
Oct. 03, 2023
Subsequent Event [Line Items]                
Sale of stock, transaction date       Mar. 27, 2024        
Proceeds from issuance of common stock           $ 1,268    
Pre-funded Warrants                
Subsequent Event [Line Items]                
Proceeds from issuance of common stock         $ 900      
Common Stock                
Subsequent Event [Line Items]                
Number of shares sold     159,683          
Common Stock | Pre-funded Warrants                
Subsequent Event [Line Items]                
Number of shares sold         90,363      
Shares issued, price per share         $ 0.0014      
Warrants issued               142,857
Private Placement | Common Stock                
Subsequent Event [Line Items]                
Warrants issued     159,683          
Securities Purchase Agreement                
Subsequent Event [Line Items]                
Sale of stock, transaction date   Nov. 13, 2024            
Shares issued, price per share             $ 7.64  
Subsequent Event | Securities Purchase Agreement | Pre-funded Warrants                
Subsequent Event [Line Items]                
Exercise price of warrants   $ 0.0001            
Beneficial ownership limitation   39.99%            
Subsequent Event | Securities Purchase Agreement | Common Stock                
Subsequent Event [Line Items]                
Number of shares sold   76,909            
Shares issued, price per share   $ 3.25            
Subsequent Event | Securities Purchase Agreement | Private Placement                
Subsequent Event [Line Items]                
Proceeds from issuance of common stock $ 2,150              
Subsequent Event | Securities Purchase Agreement | Private Placement | Common Stock | Pre-funded Warrants                
Subsequent Event [Line Items]                
Shares issued, price per share   $ 3.2499            
Warrants issued   584,646            

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