Form 10-Q - Quarterly report [Sections 13 or 15(d)]

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


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

For the quarterly period ended September 30, 2024


☐	TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

From the transition period from to

Commission File Number 001-37853

ENTERO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

46-4993860

(State or other jurisdiction of

incorporation or organization)

(I.R.S Employer

Identification No.)

777 Yamato Road, Suite 502
Boca Raton, Florida		33431
(Address of principal executive offices)		(Zip Code)

(561) 589-7020

(Registrant’s telephone number, including area code)

First Wave BioPharma, Inc.

(Former name, former address and former fiscal year, if changed since last report)

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


Title of Each Class	Trading Symbol	Name of Each Exchange on Which Registered
Common stock, par value $0.0001 per share	ENTO	The 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 ☒

There were 4,754,030 shares of the registrant’s common stock, par value $0.0001 per share (the “Common Stock”), outstanding as of November 8, 2024.

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TABLE OF CONTENTS


		Page

PART I. FINANCIAL INFORMATION

Item 1.	Unaudited Condensed Consolidated Financial Statements	1

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	30

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	39

Item 4.	Controls and Procedures	39

PART II. OTHER INFORMATION

Item 1.	Legal Proceedings	40

Item 1A.	Risk Factors	40

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	41

Item 3.	Defaults Upon Senior Securities	41

Item 4.	Mine Safety Disclosures	42

Item 5.	Other Information	42

Item 6.	Exhibits	42

SIGNATURES

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (“Quarterly Report”) contains forward-looking statements that involve substantial risks and uncertainties. All statements contained in this Quarterly Report other than statements of historical facts, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

The words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “target”, “potential”, “will”, “would”, “could”, “should”, “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about:

●

our ability to maintain compliance with the applicable listing requirements of The Nasdaq Capital Market;

●

our ability to satisfy our existing payment obligations and other payment obligations as they become due, including those related to the acquisition of First Wave Bio, Inc. and merger with ImmunogenX;

●

statements regarding the impact of geopolitical events, including the war in Ukraine and the Middle East, and their effects on our operations, access to capital, research and development and clinical trials and potential disruption in the operations and business of third-party vendors, contract research organizations (“CROs”), contract development and manufacturing organizations (“CDMOs”), other service providers, and collaborators with whom we conduct business;

●

the availability of capital to satisfy our working capital requirements;

●

our current and future capital requirements and our ability to raise additional funds to satisfy our capital needs;

●

the integration and effects of our acquisitions, including the merger with ImmunogenX, and other strategic transactions;

●

the accuracy of our estimates regarding expense, future revenue and capital requirements;

●

our ability to continue operating as a going concern;

●

our plans to develop and commercialize our product candidates, including Adrulipase, Capeserod and Niclosamide;

●

our ability to initiate and complete our clinical trials and to advance our principal product candidates into additional clinical trials, including pivotal clinical trials, and successfully complete such clinical trials;

●

regulatory developments in the U.S. and foreign countries;

●

the performance of our third-party vendor(s), CROs, CDMOs and other third-party non-clinical and clinical development collaborators and regulatory service providers;

●

our ability to obtain and maintain intellectual property protection for our core assets;

●

the size of the potential markets for our product candidates and our ability to serve those markets;

●

the rate and degree of market acceptance of our product candidates for any indication once approved;

●

the success of competing products and product candidates in development by others that are or become available for the indications that we are pursuing;

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●

the loss of key scientific, clinical and nonclinical development, and/or management personnel, internally or from one of our third-party collaborators; and

●

other risks and uncertainties, including those listed under Part I, Item 1A., “Risk Factors” in our Annual Report on Form 10-K.

Factors that may cause actual results to differ materially from current expectations include, among other things, those set forth in Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K and for the reasons described elsewhere in this Quarterly Report on Form 10-Q. Any forward-looking statement in this Quarterly Report on Form 10-Q reflects our current view with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, industry and future growth. Given these uncertainties, you should not rely on these forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

This Quarterly Report on Form 10-Q also contains estimates, projections and other information concerning our industry, our business and the markets for certain drugs and consumer products, including data regarding the estimated size of those markets, their projected growth rates and the incidence of certain medical conditions. Information that is based on estimates, forecasts, projections or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained these industry, business, market and other data from reports, research surveys, studies and similar data prepared by third parties, industry, medical and general publications, government data and similar sources and we have not independently verified the data from third party sources. In some cases, we do not expressly refer to the sources from which these data are derived.

In this Quarterly Report on Form 10-Q, unless otherwise stated or as the context otherwise requires, references to “Entero,” the “Company,” “we,” “us,” “our” and similar references are to Entero Therapeutics, Inc. and its subsidiaries on a consolidated basis. References to “FWB” refer to First Wave Bio, Inc. and references to “IMGX” refer to ImmunogenX, LLC, each of which are Entero’s wholly-owned subsidiaries.

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PART I

FINANCIAL INFORMATION

ITEM 1. UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

In our opinion, the accompanying unaudited condensed consolidated financial statements contain all adjustments (consisting only of normal recurring adjustments) necessary to present fairly our financial position, results of operations, and cash flows for the interim periods presented. We have consolidated such financial statements in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”). Therefore, such financial statements do not include all disclosures required by accounting principles generally accepted in the United States of America. In preparing these unaudited condensed consolidated financial statements, the Company has evaluated events and transactions for potential recognition or disclosure through the date the unaudited condensed consolidated financial statements were issued by filing with the SEC.

These financial statements should be read in conjunction with our audited financial statements for the year ended December 31, 2023, included in our Annual Report filed on Form 10-K, filed with the SEC on March 29, 2024.

The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the fiscal year ending December 31, 2024.

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ENTERO THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets


	September 30,
	2024		December 31,
	(unaudited)		2023
ASSETS

Current Assets:
Cash and cash equivalents	$	366,788	$	3,711,770
Prepaid expenses		305,461		1,244,466
Assets of disposal group held for sale		83,170,009		—
Total Current Assets		83,842,258		4,956,236

Property, equipment, and leasehold improvements, net		—		14,565

Other Assets:
Restricted cash		21,520		21,522
Goodwill		1,684,182		1,684,182
Operating lease right-of-use assets		144,410		195,440
Deposits		128,250		11,250
Total Other Assets		1,978,362		1,912,394
Total Assets	$	85,820,620	$	6,883,195

LIABILITIES, MEZZANINE EQUITY, AND STOCKHOLDERS’ EQUITY

Current Liabilities:
Accounts payable	$	2,214,946	$	554,277
Accrued expenses		219,193		825,290
Accrued dividend payable		1,258,450		1,069,616
Note payable		—		612,784
Operating lease liabilities		79,454		67,111
Other current liabilities		—		4,239
Liabilities of disposal group held for sale		11,918,261		—
Total Current Liabilities		15,690,304		3,133,317
Non-current operating lease liabilities		80,213		146,949
Total Liabilities		15,770,517		3,280,266

Mezzanine Equity:
Series G redeemable preferred stock- Par value $0.0001 per share; 13,000 shares designated; 12,373.226 and 0 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively		61,681,100		—
Total Mezzanine Equity		61,681,100		—

Stockholders’ Equity:
Common stock - Par value $0.0001 per share; 100,000,000 shares authorized; 4,741,964 and 1,560,998 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively		474		156
Series B preferred stock- Par value $0.0001 per share; 5,194.81 shares authorized; 484.52 and 514.96 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively		—		—
Series C preferred stock- Par value $0.0001 per share; 75,000 shares authorized; 0 shares issued and outstanding at September 30, 2024 and December 31, 2023		—		—
Series D preferred stock- Par value $0.0001 per share; 150 shares designated; 0 shares issued and outstanding at September 30, 2024 and December 31, 2023		—		—
Series E preferred stock- Par value $0.0001 per share; 150 shares designated; 0 shares issued and outstanding at September 30, 2024 and December 31, 2023		—		—
Series F preferred stock- Par value $0.0001 per share; 7,000 shares designated; 0 shares issued and outstanding at September 30, 2024 and December 31, 2023		—		—
Additional paid-in capital		198,518,268		187,931,445
Accumulated deficit		(190,149,739)		(184,328,672)
Total Stockholders’ Equity		8,369,003		3,602,929
Total Liabilities, Mezzanine Equity and Stockholders’ Equity	$	85,820,620	$	6,883,195

See accompanying notes to unaudited condensed consolidated financial statements

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ENTERO THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations (unaudited)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Operating expenses:
Research and development expenses	$	206,999	$	1,011,055	$	882,522	$	3,725,833
General and administrative expenses		1,685,608		2,422,082		13,535,241		7,951,373
Total operating expenses		1,892,607		3,433,137		14,417,763		11,677,206

Loss from operations		(1,892,607)		(3,433,137)		(14,417,763)		(11,677,206)

Other expenses:
Interest income (expense), net		229		(1,021)		675		(13,108)
Other expense, net		(2,874)		—		(7,859)		(3,729)
Total other expenses		(2,645)		(1,021)		(7,184)		(16,837)

Loss before income tax benefit	$	(1,895,252)	$	(3,434,158)	$	(14,424,947)	$	(11,694,043)

Income tax benefit		—		—		10,604,640		—
Net loss from continuing operations	$	(1,895,252)	$	(3,434,158)	$	(3,820,307)	$	(11,694,043)

Loss from discontinued operations		(685,719)		—		(2,000,760)		—
Net loss	$	(2,580,971)	$	(3,434,158)	$	(5,821,067)	$	(11,694,043)

Preferred stock dividends		(84,632)		(49,292)		(150,776)		(231,047)
Net loss applicable to common shareholders	$	(2,665,603)	$	(3,483,450)	$	(5,971,843)	$	(11,925,090)

Weighted average shares outstanding, basic and diluted		4,552,019		378,301		3,005,055		188,175
Loss per share, basic and diluted	$	(0.59)	$	(9.21)	$	(1.99)	$	(63.37)
Loss per share from discontinued operations, basic and diluted	$	(0.15)	$	—	$	(0.67)	$	—

See accompanying notes to unaudited condensed consolidated financial statements

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ENTERO THERAPEUTICS, INC.

Condensed Consolidated Statements of Mezzanine Equity and Changes in Stockholders’ Equity (unaudited)


	Series G Convertible			Series B Convertible						Additional				Total
	Preferred Stock			Preferred Stock			Common Stock			Paid In		Accumulated		Stockholders’
	Shares	Amount		Shares	Amount		Shares	Amount		Capital		Deficit		Equity
Balance, July 1, 2024	12,373	$	61,681,100	485	$	—	2,941,108	$	294	$	196,689,069	$	(187,568,768)	$	9,120,595
Issuance of common stock in connection with the exercise of warrants in the July 2024 Inducement Offering, net of offering costs	—		—	—		—	1,762,674		176		1,730,189		—		1,730,365
Deemed dividend of Series B preferred stock	—		—	—		—	—		—		(84,632)		—		(84,632)
Issuance of common stock from RSU vest	—		—	—		—	38,182		4		(4)		—		—
Stock-based compensation	—		—	—		—	—		—		183,646		—		183,646
Net loss	—		—	—		—	—		—		—		(2,580,971)		(2,580,971)
Balance, September 30, 2024	12,373	$	61,681,100	485	$	—	4,741,964	$	474	$	198,518,268	$	(190,149,739)	$	8,369,003


	Series B Convertible						Additional				Total
	Preferred Stock			Common Stock			Paid In		Accumulated		Stockholders’
	Shares	Amount		Shares	Amount		Capital		Deficit		Equity
Balance, July 1, 2023	546	$	—	210,450	$	21	$	177,675,513	$	(176,793,574)	$	881,960
Issuance of common stock, pre-funded warrants and warrants in July 2023 offering, net of issuance costs	—		—	30,500		3		1,833,924		—		1,833,927
Issuance of common stock in connection with the exercise of warrants in the September 2023 Inducement Offering, net of offering costs	—		—	294,101		29		3,706,742		—		3,706,771
Exercise of pre-funded warrants into Common Stock	—		—	133,750		14		253		—		267
Deemed dividend of Series B preferred stock	—		—	—		—		(49,292)		—		(49,292)
Conversion of Series B preferred shares into common stock	(24)		—	22		—		—		—		—
Common stock issued to consultants	—		—	2,500		—		76,000		—		76,000
Issuance of Common Stock from RSU vest	—		—	1,851		—		—		—		—
Stock-based compensation	—		—	—		—		263,330		—		263,330
Net loss	—		—	—		—		—		(3,434,158)		(3,434,158)
Balance, September 30, 2023	522	$	—	673,174	$	67	$	183,506,470	$	(180,227,732)	$	3,278,805

See accompanying notes to unaudited condensed consolidated financial statements

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ENTERO THERAPEUTICS, INC.

Condensed Consolidated Statements of Mezzanine Equity and Changes in Stockholders’ Equity (unaudited)


	Series G Convertible			Series B Convertible						Additional				Total
	Preferred Stock			Preferred Stock			Common Stock			Paid In		Accumulated		Stockholders’
	Shares	Amount		Shares	Amount		Shares	Amount		Capital		Deficit		Equity
Balance, January 1, 2024	—	$	—	515	$	—	1,560,998	$	156	$	187,931,445	$	(184,328,672)	$	3,602,929
Issuance of common stock, pre-funded warrants and warrants in registered direct offerings, net of issuance costs	—		—	—		—	448,100		44		4,495,482		—		4,495,526
Issuance of common stock in connection with the exercise of warrants in the July 2024 Inducement Offering, net of offering costs	—		—	—		—	1,762,674		176		1,730,189		—		1,730,365
Issuance of Series G convertible preferred stock upon acquisition of IMGX	11,777		57,790,474	—		—	—		—		—		—		—
Issuance of common stock upon acquisition of IMGX	—		—	—		—	36,830		4		2,300,496		—		2,300,500
Issuance of Series G convertible preferred stock to financial advisors	596		3,890,626	—		—	—		—		—		—		—
Issuance of common stock to financial advisors	—		—	—		—	18,475		2		120,646		—		120,648
Exercise of pre-funded warrants into common stock	—		—	—		—	443,525		45		—		—		45
Deemed dividend of Series B preferred stock	—		—	—		—	—		—		(188,834)		—		(188,834)
Conversion of Series B preferred shares into common stock	—		—	(30)		—	27		—		—		—		—
Common stock issued to consultants	—		—	—		—	350,000		35		1,541,960		—		1,541,995
Issuance of common stock from RSU vest	—		—	—		—	121,335		12		(12)		—		—
Stock-based compensation	—		—	—		—	—		—		586,896		—		586,896
Net loss	—		—	—		—	—		—		—		(5,821,067)		(5,821,067)
Balance, September 30, 2024	12,373	$	61,681,100	485	$	—	4,741,964	$	474	$	198,518,268	$	(190,149,739)	$	8,369,003


	Series B Convertible						Additional				Total
	Preferred Stock			Common Stock			Paid In		Accumulated		Stockholders’
	Shares	Amount		Shares	Amount		Capital		Deficit		Equity
Balance, January 1, 2023	550	$	—	49,750	$	5	$	171,275,836	$	(168,533,689)	$	2,742,152
Issuance of common stock, pre-funded warrants and warrants in private placement, net of issuance costs	—		—	6,400		1		3,690,972		—		3,690,973
Issuance of Common Stock in connection with the exercise of warrants in the June 2023 Inducement Offering, net of offering costs	—		—	86,216		8		2,239,057		—		2,239,065
Issuance of common stock, pre-funded warrants and warrants in July 2023 offering, net of issuance costs	—		—	30,500		3		1,833,924		—		1,833,927
Issuance of common stock in connection with the exercise of warrants in the September 2023 Inducement Offering, net of offering costs	—		—	294,101		29		3,706,742		—		3,706,771
Exercise of pre-funded warrants into common stock	—		—	199,974		21		636		—		657
Deemed dividend of Series B preferred stock	—		—	—		—		(231,047)		—		(231,047)
Conversion of Series B preferred shares into common stock	(28)		—	26		—		—		—		—
Common stock issued to consultants	—		—	2,500		—		76,000		—		76,000
Issuance of common stock from RSU vest	—		—	3,854		—		—		—		—
Effect of cancelled shares from the 1-for-7 reverse stock split	—		—	(147)		—		—		—		—
Stock-based compensation	—		—	—		—		914,350		—		914,350
Net loss	—		—	—		—		—		(11,694,043)		(11,694,043)
Balance, September 30, 2023	522	$	—	673,174	$	67	$	183,506,470	$	(180,227,732)	$	3,278,805

See accompanying notes to unaudited condensed consolidated financial statements

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ENTERO THERAPEUTICS, INC.

Condensed Consolidated Statements of Cash Flows (unaudited)


	Nine Months Ended September 30,
	2024		2023
Cash flows from operating activities:
Net loss	$	(5,821,067)	$	(11,694,043)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		48,946		21,955
Amortization of debt discount		5,848		—
Change in right-of-use assets		55,262		47,429
Stock-based compensation		586,896		914,350
Common stock granted to consultants		1,541,995		76,000
Common stock issued to financial advisors at acquisition		120,648		—
Series G convertible preferred stock issued to financial advisors at acquisition		3,890,626		—
Deferred taxes		(10,604,640)		—
Changes in assets and liabilities:
Other receivables		—		93,014
Prepaid expenses		939,005		1,272,558
Lease liabilities		(58,004)		(48,919)
Deposits		(117,000)		6,899
Accounts payable		900,546		(140,749)
Accrued expenses		(531,127)		514,364
Other liabilities		(4,239)		(1,332)
Net cash used in operating activities		(9,046,305)		(8,938,474)

Cash flows from investing activities:
Cash acquired in acquisition of IMGX		88,169		—
Net cash provided by investing activities		88,169		—

Cash flows from financing activities:
Proceeds from issuance of common stock, prefunded warrants and warrants, net		4,495,526		5,525,010
Proceeds from the issuance of common stock in connection with the exercise of warrants in the July 2024 Inducement Offering, net		1,730,365		—
Proceeds from exercise of warrants, net of issuance costs		—		5,946,383
Proceeds from exercise of pre-funded warrants		45		—
Repayments of note payable		(644,582)		(603,494)
Proceeds from note payable		31,798		—
Net cash provided by financing activities		5,613,152		10,867,899

Net (decrease) increase in cash, cash equivalents and restricted cash		(3,344,984)		1,929,425

Cash, cash equivalents and restricted cash, beginning balance		3,733,292		1,384,423
Cash, cash equivalents and restricted cash, ending balance	$	388,308	$	3,313,848

Supplemental disclosures of cash flow information:
Cash paid for interest	$	30,468	$	15,414

Non-cash investing and financing activities:
Fair value of common shares issued in the IMGX acquisition, net of cash	$	152,331	$	—
Fair value of the Series G preferred stock issued in the IMGX acquisition	$	57,790,474	$	—
Fair value of options assumed in the IMGX acquisition	$	1,271,000	$	—
Fair value of warrants assumed in the IMGX acquisition	$	789,000	$	—
Accrued dividends on preferred stock	$	(188,834)	$	(231,047)

See accompanying notes to unaudited condensed consolidated financial statements

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ENTERO THERAPEUTICS, INC.

Notes to Unaudited Condensed Consolidated Financial Statements

September 30, 2024

Note 1 - The Company and Basis of Presentation

The Company

Entero Therapeutics, Inc. (“Entero”) and its wholly-owned subsidiaries, First Wave Bio, Inc. (“FWB”) and ImmunogenX, LLC (“IMGX”), are collectively referred to as the “Company”. The Company is engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (“GI”) diseases. Non-systemic therapies are non-absorbable drugs that act locally, i.e., in the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation.

In May 2024, the Company changed its name from First Wave Biopharma, Inc. to Entero Therapeutics, Inc.

In March 2024, the Company acquired ImmunogenX, Inc. (“ImmunogenX”) (the Company’s acquisition of ImmunogenX, the “Merger”), a private, clinical-stage biopharmaceutical company founded in 2013, which was developing the biologic, Latiglutenase, for celiac disease. ImmunogenX was also developing CypCel, a metabolic marker compound that can measure the state of small-intestinal recovery of celiac patients undergoing gluten-free diets (“GFDs”).

The Company is seeking avenues to dispose of certain assets and liabilities of IMGX within 12 months of the date of the Merger, including Latiglutenase and CypCel. As of September 30, 2024, these were classified as assets and liabilities held for sale and due to the short period of time since the close of the Merger and are reported at their fair value less cost to sell. The Company determined that the discontinued operations of IMGX represents a strategic shift that will have a major effect on the Company’s operations and financial statements. See Note 3 for additional details regarding the Merger and see Note 4 for additional details surrounding the Company’s assets and liabilities held for sale and discontinued operations.

The Company’s development pipeline consists of gut-restricted GI clinical drug candidates, including the biologic Adrulipase (formerly MS1819), a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients, and Capeserod, a selective 5-HT4 receptor partial agonist which the Company plans to pursue for GI indications. The Company is exploring strategic alternatives for its Niclosamide program, an oral small molecule with anti-viral and anti-inflammatory properties. All of the Company’s programs are currently on hold due to capital constraints.

Risks and Uncertainties

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development and regulatory success, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, and ability to secure additional capital to fund clinical trials and operations.

Worldwide supply chain constraints and economic and capital markets uncertainty arising out of conflicts between Russia and Ukraine and conflicts in the Middle East triggered by attacks on Israel in October of 2023 have disrupted commercial and capital markets and emerged as new barriers to long-term economic recovery. Capital markets uncertainty, with public stock price decreases and volatility, could make it more difficult for us to raise capital when needed.

In addition, the Company is subject to other challenges and risks specific to its business, its ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and its ability to execute on its strategy, as well as risks and uncertainties common to companies in the biotechnology and pharmaceutical industries with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of its drug candidates; delays or problems in the manufacture and supply of its drug candidates, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or drug candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing our intellectual property rights; complying with applicable regulatory requirements.

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Principles of Consolidation

The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and include the accounts of Entero and its wholly owned subsidiaries, FWB and IMGX. Intercompany transactions and balances have been eliminated upon consolidation.

In our opinion, the accompanying unaudited interim condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our financial position, results of operations, and cash flows. The consolidated balance sheet at December 31, 2023, has been derived from audited financial statements of that date. The unaudited interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with GAAP have been omitted pursuant to instructions, rules, and regulations prescribed by the SEC. The Company believes that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited interim condensed consolidated financial statements are read in conjunction with the audited financial statements and notes previously distributed in our Annual Report Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024.

Substantial Doubt about the Company’s Ability to Continue as a Going Concern

The accompanying unaudited interim condensed consolidated financial statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses and negative cash flows from operations since inception. On September 30, 2024, the Company had cash and cash equivalents of approximately $0.4 million and an accumulated deficit of approximately $190.1 million. The Company has incurred recurring losses, has experienced recurring negative operating cash flows, and requires significant cash resources to execute its business plans. Based on its cash on hand at September 30, 2024, the Company anticipates having sufficient cash to fund planned operations into December 2024. Historically, the Company’s major sources of cash have been comprised of proceeds from various public and private offerings of its capital stock. The Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plans and continue operations.

The Company has been, and is expected to continue, exploring various potential strategies available including but not limited to raising capital, restructuring its indebtedness and identifying and evaluating potential strategic alternatives but there can be no assurance that these efforts will be successful, that the Company will be able to raise necessary capital on acceptable terms, reach agreement with lenders, or that the strategic review process will result in the Company pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. The Company is evaluating all potential strategic options, including a merger, reverse merger, sale, wind-down, liquidation and dissolution or other strategic transaction. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stakeholder value or that it will make any cash distributions to stockholders. Any failure in these efforts could force the Company to delay, limit or terminate operations, make reductions in its workforce, discontinue research and development programs, liquidate all or a portion of assets or pursue other strategic alternatives, and/or seek protection under the provisions of the U.S. Bankruptcy Code.

Without adequate working capital, the Company may not be able to meet its obligations and continue as a going concern. These conditions raise substantial doubt about the Company’s ability to continue as a going concern one year from the date these financial statements are issued. If the Company is not able to obtain necessary capital, it may be required to terminate operations, liquidate all or a portion of assets and/or seek bankruptcy protection. As a result, the Company concluded that its plans at this stage do not alleviate substantial doubt about the ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Note 2 - Significant Accounting Policies and Recent Accounting Pronouncements

Use of Estimates

The accompanying unaudited condensed consolidated financial statements are prepared in conformity with GAAP and include certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements (including goodwill), and the reported amounts of revenue and expense during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates.

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Reverse Stock Split

On December 18, 2023, the Company effected a reverse stock split, whereby every twenty shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share.

On January 18, 2023, the Company effected a reverse stock split, whereby every seven shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share.

All share and per share amounts have been retroactively restated to reflect the reverse stock splits referenced above.

Cash and Cash Equivalents and Restricted Cash

The Company considers all highly liquid investments with maturities of three months or less from the date of purchase to be cash equivalents. All cash and cash equivalent balances were highly liquid at September 30, 2024 and December 31, 2023. As of September 30, 2024 and December 31, 2023, the Company has classified approximately $0.02 million as restricted cash.

Concentrations of Credit Risk

Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash. The Company primarily maintains its cash balances with financial institutions in federally insured accounts in the U.S. The Company may from time to time have cash in banks in excess of FDIC insurance limits. At September 30, 2024 the Company had approximately $0.4 million in one account in the U.S. which was in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company mitigates its risk by maintaining the majority of its cash and equivalents with high quality financial institutions.

Fair Value Measurements

The Company follows Accounting Standards Codification (“ASC”) Topic 820-10, Fair Value Measurements and Disclosures (“ASC 820”), which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.

As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:

Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;

Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use.

In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument.

The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period.

Goodwill

Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company has not recognized any impairment charges through September 30, 2024 related to goodwill.

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Impairment of Long-Lived Assets

The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment (“ASC 360”). Potential impairment is assessed when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. The recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends and product development cycles. If impairments are identified, assets are written down to their estimated fair value. The Company has not recognized any impairment charges through September 30, 2024.

Income Taxes

Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. The Company determines its deferred tax assets and liabilities based on differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. At September 30, 2024 and 2023, the Company does not have any significant uncertain tax positions.

Leases

Leases are recorded on the balance sheet as right of use assets and lease obligations. Lease liabilities are recognized based on the present value of the future minimum lease payments over the least term at the commencement date. Leases with a term of 12 months or less at inception are expensed monthly over the lease term. The lease term is determined by assuming the exercise of renewal options that are reasonably certain. The implicit interest rate or the incremental borrowing rate is used in determining the present value of future payments.

Research and Development

Research and development costs are charged to operations when incurred and are included in operating expenses, except for goodwill related to patents. Research and development costs consist principally of compensation of employees and consultants that perform the Company’s research activities, payments to third parties for preclinical and non-clinical activities, expenses with clinical research organizations (“CROs”), investigative sites, consultants and contractors that conduct or provide other services relating to clinical trials, costs to acquire drug product, drug supply and clinical trial materials from contract development and manufacturing organization (“CDMOs”) and third-party contractors relating to chemistry, manufacturing and controls (“CMC”) efforts, the fees paid for and to maintain the Company’s licenses and research and development costs related to Adrulipase, Capeserod and Niclosamide. Depending upon the timing of payments to the service providers, the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s estimates of the work performed under service agreements, milestones achieved and experience with similar contracts. The Company monitors each of these factors and adjusts estimates accordingly.

Research and Development – Intellectual Property Acquired

The Company records intellectual property acquired in business acquisitions that has not reached technological feasibility and which has no alternative future use, as In-Process R&D (“IPR&D”) at the acquisition date. On March 13, 2024, the Company entered into an acquisition agreement with IMGX which included the intellectual property and patents for Latiglutenase and CypCel, which was accounted for as a business acquisition (see Note 3 and Note 4).

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Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-off, and the Company will record a noncash impairment loss on its Consolidated Statements of Operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. The impairment test for indefinite-lived intangible assets is a one-step test that compares the fair value of the intangible asset to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. The Company has not recognized any impairment charges through September 30, 2024 related to IPR&D.

For tax purposes, intangible assets related to IPR&D are considered indefinite-lived intangible assets.

Stock-Based Compensation

The Company’s board of directors (the “Board”) and stockholders have adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “2014 Plan”) which took effect on May 12, 2014, and the 2020 Omnibus Equity Incentive Plan, which took effect on September 11, 2020 (the “2020 Plan”). From the effective date of the 2020 Plan, no new awards have been or will be made under the 2014 Plan. On March 13, 2024, in connection with the IMGX acquisition, the Company assumed IMGX’s 2021 Stock Option Plan (the “IMGX Plan”), including all IMGX stock options immediately outstanding prior to the IMGX acquisition, with each becoming an option to purchase Common Stock, subject to adjustment. The IMGX Plan was adopted and approved by the board of directors and stockholders of IMGX in 2021. Following the assumption of the IMGX Plan by the Company, no new awards have been or will be made under the IMGX Plan. The Company accounts for its stock-based compensation awards to employees, consultants, and Board members in accordance with ASC Topic 718, Compensation-Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, consultants, and Board members, including grants of employee stock options, to be recognized in the statements of operations by measuring the fair value of the award on the date of grant and recognizing this fair value as stock-based compensation using a straight-line method over the requisite service period, generally the vesting period.

For awards with performance conditions that affect their vesting, such as the occurrence of certain transactions or the achievement of certain operating or financial milestones, recognition of fair value of the award occurs when vesting becomes probable.

The Company estimates the grant date fair value of stock option awards using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock.

Assets Held for Sale and Discontinued Operations

Assets and liabilities are classified as held for sale when all of the following criteria for a plan of sale have been met: (1) management, having the authority to approve the action, commits to a plan to sell the assets; (2) the assets are available for immediate sale, in their present condition, subject only to terms that are usual and customary for sales of such assets; (3) an active program to locate a buyer and other actions required to complete the plan to sell the assets have been initiated; (4) the sale of the assets is probable and is expected to be completed within one year; (5) the assets are being actively marketed for a price that is reasonable in relation to their current fair value; and (6) actions required to complete the plan indicate that it is unlikely that significant changes to the plan will be made or the plan will be withdrawn. When all of these criteria have been met, the assets and liabilities are classified as held for sale in the condensed consolidated balance sheet. A newly acquired business in a business combination that has met the held for sale criteria should be measured at fair value less costs to sell. This is because the business has been recently acquired and its carrying value has been adjusted to its fair value. Depreciation and amortization of assets cease upon designation as held for sale.

Discontinued operations comprise activities that were disposed of, discontinued or held for sale at the end of the period, represent a separate major line of business that can be clearly distinguished for operational and financial reporting purposes, and represent a strategic business shift having a major effect on the Company’s operations and financial results according to ASC Topic 205, Presentation of Financial Statements.

Additional details surrounding the Company’s assets and liabilities held for sale and discontinued operations are included in Note 4.

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Recent Accounting Pronouncements

The Company has evaluated recently issued accounting pronouncements and has concluded that the impact of recently issued standards that are not yet effective, will not have a material impact on the Company’s financial position or results of operations upon adoption.

Note 3 – Business Acquisition

On March 13, 2024, the Company acquired ImmunogenX, Inc., a Delaware corporation, in accordance with the terms of an Agreement and Plan of Merger, dated March 13, 2024 (the “Merger Agreement”), by and among the Company, IMMUNO Merger Sub I, Inc., a Delaware corporation (“First Merger Sub”), IMMUNO Merger Sub II, LLC, a Delaware limited liability company (“Second Merger Sub”), and ImmunogenX. Pursuant to the Merger Agreement, First Merger Sub merged with and into ImmunogenX, pursuant to which ImmunogenX was the surviving corporation (the “First Merger”). Immediately following the First Merger, IMGX merged with and into Second Merger Sub, pursuant to which Second Merger Sub was the surviving entity and a wholly owned subsidiary of the Company (the “Second Merger” and, together with the First Merger, the “IMGX Merger”). Second Merger Sub subsequently changed its name to ImmunogenX, LLC. The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes.

Under the terms of the Merger Agreement, following the consummation of the Merger (the “Closing”), in exchange for the outstanding shares of capital stock of ImmunogenX immediately prior to the effective time of the First Merger, the Company issued to the stockholders of ImmunogenX an aggregate of (A) 36,830 shares of Common Stock, and (B) 11,777.418 shares of Series G Preferred Stock, each share of which is convertible into 1,000 shares of Common Stock, upon shareholder approval. Following the closing of the acquisition, the Company had 2,303,135 shares of common stock issued and outstanding.

The Company incurred transaction costs of $5,456,038 which are included in the Company’s condensed consolidated statement of operations.

In addition, the Company assumed (i) all ImmunogenX stock options immediately outstanding prior to the First Merger, each becoming an option to purchase Common Stock subject to adjustment pursuant to the terms of the Merger Agreement (the “Assumed Options”) and (ii) all ImmunogenX warrants immediately outstanding prior to the First Merger, each becoming a warrant to purchase Common Stock subject to adjustment pursuant to the terms of the Merger Agreement (the “Assumed Warrants”). The Assumed Options are exercisable for an aggregate of 200,652 shares of Common Stock, have an exercise price of $0.81 and expire between February 1, 2031 and June 6, 2033. The Assumed Warrants are exercisable for an aggregate of 127,680 shares of Common Stock, have exercise prices ranging from $3.03 to $3.92 and expire between September 30, 2032 and September 6, 2033.

Tungsten Partners LLC (“Tungsten”) acted as financial advisor to the Company in connection with the Merger. As partial compensation for services rendered by Tungsten, the Company issued to Tungsten or its affiliates or designees an aggregate of 18,475 shares of Common Stock and 595.808 shares of Series G Preferred Stock. The fair value of the advisory fees was approximately $4.0 million which are included in the approximately $5.5 million of transaction costs noted above.

The Merger was accounted for as a business combination under the acquisition method of accounting with First Wave as the accounting acquirer. Under the acquisition method, the total purchase price of the acquisition is allocated to the net identifiable tangible and intangible assets acquired and liabilities assumed based on the fair values as of the date of such acquisition. The preliminary fair value of the consideration totaled approximately $60.1 million, summarized as follows:


	Amount
Common stock issued to ImmunogenX stockholders	$	240,500
Replacement options		1,271,000
Replacement warrants		789,000
Preferred stock issued to ImmunogenX stockholders		57,790,474
Total consideration paid	$	60,090,974

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The Company has made a provisional allocation of the purchase price of the Merger to the assets acquired and the liabilities assumed as of the purchase date. The following table summarizes the provisional purchase price allocations relating to the Merger:


Assets acquired:
Cash and cash equivalents	$	88,169
Prepaid expenses and other current assets		3,131,929
Property and equipment, net		18,963
Intangibles		63,370,000
Operating lease right-of-use assets		4,232
Total assets	$	66,613,293
Liabilities assumed:
Accounts payable		916,209
Accrued expenses and other current liabilities		2,131,439
Long term debt		6,397,889
Deferred tax liability		13,760,280
Total liabilities	$	23,205,817
Goodwill recorded:
Goodwill	$	16,683,498
Net assets acquired	$	60,090,974

The fair value of IPR&D was capitalized as of the IMGX Merger date and accounted for as indefinite-lived intangible assets until completion or disposition of the assets or abandonment of the associated research and development efforts. Upon successful completion of the development efforts, the useful lives of the IPR&D assets will be determined based on the anticipated period of regulatory exclusivity and will be amortized within operating expenses. Until that time, the IPR&D assets will be subject to impairment testing and will not be amortized. The goodwill recorded related to the IMGX Merger is the excess of the fair value of the consideration transferred by the acquirer over the fair value of the net identifiable assets acquired and liabilities assumed at the date of such acquisition. The goodwill recorded is not deductible for tax purposes.

All intangible assets acquired are subject to amortization and their associated estimated acquisition date fair values are as follows:


	Estimated	Acquisition Date
Intangible Asset	Useful Life	Fair Value
Patents	2 years	$	140,000
Trade names and trademarks	6 years		230,000
IPR&D – Latiglutenase	Indefinite		54,000,000
IPR&D - CypCel	Indefinite	$	9,000,000

Net loss in the Condensed Consolidated Statement of Operations for the nine months ended September 30, 2024 includes net losses of IMGX from the date of acquisition to September 30, 2024 of approximately $2.0 million, which is classified as discontinued operations.

The Merger is classified as held for sale as of September 30, 2024. Refer to Note 4 for further information.

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Pro forma disclosure for the IMGX acquisition

The following unaudited pro forma financial information reflects the consolidated results of operations of the Company as if the Acquisition had taken place on January 1, 2024. The pro forma financial information is not necessarily indicative of the results of operations as they would have been had the transactions been effected on the assumed date:


	Three Months		Nine Months
	Ended September 30, 2024		Ended September 30, 2024
Operating expenses	$	1,892,607	$	14,417,763
Loss before income tax benefit		(1,895,252)		(14,424,947)
Loss from discontinued operations		(685,719)		(9,374,674)
Net loss applicable to common shareholders		(2,665,603)		(13,345,757)

Basic and diluted weighted average shares outstanding		4,552,019		3,005,055
Loss per share - basic and diluted	$	(0.59)	$	(4.44)

Notes 4 – Discontinued Operations and Assets and Liabilities Held for Sale

The Company has initiated a plan to dispose of certain assets and liabilities of IMGX within 12 months of the date of the Merger with IMGX. These are classified as assets and liabilities held for sale and, due to the short period of time since the close of the Merger, are reported at their fair value less cost to sell. The Company determined that the discontinued operations of IMGX represents a strategic shift that will have a major effect on the Company’s operations and financial statements.

The following table summarizes the Company’s loss from discontinued operations for the three and nine months ended September 30, 2024 and 2023.


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Operating expenses:
Research and development expenses	$	301,661	$	—	$	1,225,533	$	—
General and administrative expenses		76,971		—		152,187		—
Total operating expenses		378,632		—		1,377,720		—
Interest expense		(305,614)		—		(670,296)		—
Other (expense) income		(1,473)		—		47,256		—
Loss from discontinued operations	$	(685,719)	$	—	$	(2,000,760)	$	—

The assets and liabilities associated with discontinued operations consist of the following as of September 30, 2024:


Assets held for sale:
Prepaid expenses and other current assets	$	3,131,929
Property and equipment, net		16,180
Goodwill and intangible assets		80,021,900
Total assets held for sale	$	83,170,009
Liabilities held for sale:
Accounts payable	$	156,086
Accrued expenses and other current liabilities		2,202,798
Debt		6,403,737
Deferred tax liability		3,155,640
Total liabilities held for sale	$	11,918,261

Total assets and liabilities classified as held for sale are presented as current assets and liabilities, respectively, as they are anticipated to be sold within 12 months.

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Note 5 - Fair Value Disclosures

Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework that prioritizes and ranks the level of observability of inputs used in measuring fair value.

The fair value of the Company’s financial instruments are as follows:


			Fair Value Measured at Reporting Date
			Using
	Carrying
	Amount		Level 1		Level 2		Level 3		Fair Value
September 30, 2024 (unaudited):
Money market funds	$	12,573	$	12,573	$	—	$	—	$	12,573

December 31, 2023:
Money market funds	$	12,131	$	12,131	$	—	$	—	$	12,131
Note payable		612,784		—		612,784	$	—		612,784

At September 30, 2024 and December 31, 2023, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with U.S. GAAP.

Note 6 – Property, Equipment and Leasehold Improvements

Property, equipment and leasehold improvements consisted of the following:


	September 30,
	2024		December 31,
	(unaudited)		2023
Computer equipment and software	$	11,540	$	11,540
Office equipment		48,278		48,278
Leasehold improvements		28,000		28,000
Total property, equipment and leasehold improvements		87,818		87,818
Less accumulated depreciation		(87,818)		(73,253)
Property, equipment and leasehold improvements, net	$	—	$	14,565

Depreciation expense for the three months ended September 30, 2024 and 2023 was approximately $1,000 and $7,000. Depreciation expense for the nine months ended September 30, 2024 and 2023 was approximately $15,000 and $22,000, respectively. Fixed assets held for sale at September 30, 2024 and 2023 in the amount of $16,000 and $0, respectively, are included in assets held for sale. Depreciation of assets ceases upon designation as held for sale.

Note 7 –Goodwill

Goodwill is as follows:


	Goodwill
Balance on January 1, 2023	$	1,684,182
Balance on December 31, 2023		1,684,182
Goodwill associated with IMGX acquisition		16,683,498
Goodwill reclassified as held for sale	$	(16,683,498)
Balance on September 30, 2024 (unaudited)	$	1,684,182

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Note 8 – Intangible Assets and In-Process R&D

Intangible assets consist of IPR&D, patents, tradenames and trademarks acquired from ImmunogenX. As of September 30, 2024, Intangible assets have been reclassified as held for sale. Intangible assets and IPR&D activity is as follows:


	Estimated	September 30,
	Useful Life	2024
Patents	2 years	$	140,000
Trademarks and trade names	6 years		230,000
Less: accumulated amortization			(31,598)
Intangible assets, net			338,402
In-process R&D			63,000,000
Intangible assets and in-process R&D reclassified as held for sale			(63,338,402)
Total intangible assets and in-process R&D, net		$	—

Note 9 - Accrued Expenses

Accrued expenses consisted of the following:


	September 30,
	2024		December 31,
	(unaudited)		2023
Professional fees		215,531		253,577
Consulting fees		—		75,972
Payroll and benefits		3,662		495,741
Total accrued expenses	$	219,193	$	825,290

Accrued expenses in the amount of $2.2 million and $0 were reclassified as assets held for sale as of September 30, 2024 and 2023, respectively.

Note 10 – Capital Stock

Common Stock and Preferred Stock

The Company’s amended and restated certificate of incorporation, as amended to date, (the “Charter”) authorizes the issuance of up to 100,000,000 shares of Common Stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share.

The Company had 4,741,964 and 1,560,998 shares of its Common Stock issued and outstanding on September 30, 2024 and December 31, 2023, respectively.

The Company had approximately 484.52 and 514.96 shares of Series B preferred stock issued and outstanding on September 30, 2024 and December 31, 2023, respectively.

The Company had 0 shares of Series C, Series D, Series E and Series F preferred stock issued and outstanding on September 30, 2024 and December 31, 2023.

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Most Favored Nations Exchange Right and Waiver Agreements

In the event the Company effects any issuance by the Company or any of its subsidiaries of Common Stock or Common Stock equivalents for cash consideration, or a combination of units thereof (a “Subsequent Financing”), each holder of the Series B Preferred Stock had the right, subject to certain exceptions set forth in the Series B Certificate of Designations, at its option, to exchange (in lieu of cash subscription payments) all or some of the Series B Preferred Stock then held (with a value per share of Series B Preferred Stock equal to the stated value of each share of Series B Preferred Stock, or $7,700.00, plus accrued and unpaid dividends thereon, of the Series B Preferred Stock (the “Exchange Amount”)) for any securities or units issued in a Subsequent Financing on dollar-for-dollar basis (the “Series B Exchange Right”). Effective May 12, 2022, the holders of 81.3% of the outstanding shares of the Series B Preferred Stock permanently waived for themselves and all other holders of the Series B Preferred Stock the Series B Exchange Right with respect to any Subsequent Financing occurring on or after January 1, 2022 (the “Permanent Waiver”). Holders of Series B Preferred Stock as of the April 27, 2022 record date were entitled to notice of and to consent to the Permanent Waiver (the “Record Holders”).

As of September 30, 2024, (i) holders of approximately 1,839.76 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $14.4 million had previously elected to exercise their Series B Exchange Rights into Series C Preferred Stock, convertible into an aggregate of 395 shares of Common Stock (which conversion the Company has elected to make in full), and additional Investor Warrants exercisable for up to an aggregate of 395 shares of Common Stock, (ii) holders of approximately 160.62 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $1.5 million had previously elected to exercise their Series B Exchange Rights into 128 shares of Common Stock with no warrants, and (iii) holders of approximately 30.91 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $265,000 had previously elected to exercise their Series B Exchange Rights into 44 shares of Common Stock, and additional Series C Warrants exercisable for up to an aggregate of 44 shares of Common Stock.

Mezzanine Equity

Series G Preferred Stock

The Company had 12,373.226 and 0 shares of Series G stock issued and outstanding on September 30, 2024 and December 31, 2023, respectively.

On March 13, 2024, the Company issued 12,373.226 shares of Series G Preferred stock in connection with the IMGX Merger. The following is a summary of the principal terms of the Series G Preferred Stock as set forth in the Certificate of Designation of the Series G Preferred Stock:

General; Transferability. Share of Series G Preferred Stock will be uncertificated and issued in book-entry form. Shares of Series G Preferred Stock may be transferred by the holders thereof without the consent of the Company, provided that such transfer is in compliance with applicable securities laws.

Conversion. Following stockholder approval of the conversion of the Series G Preferred Stock into Common Stock in accordance with the listing rules of the Nasdaq Stock Market (the “Conversion”), each share of Series G Preferred Stock will automatically convert into 1,000 shares of Common Stock, subject to certain limitations, including that a holder of Series G Preferred Stock is prohibited from converting shares of Series G Preferred Stock into shares of Common Stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the holder between 4.9% and 19.9%) of the total number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion.

The Series G Preferred Stock is redeemable for cash at the option of the holder thereof at any time following the date that is six months after the initial issuance of the Series G Preferred Stock (without regard to the lack of obtaining the requisite stockholder approval to convert the Series G Preferred Stock into Common Stock), at a price per share equal to the then-current fair value of the Series G Preferred Stock, which shall be the last reported closing sale price of the Company’s Common Stock as reported on the Nasdaq Stock Market as of the trading day immediately prior to the conversion event. As such, Series G Preferred Stock is classified as Mezzanine Equity on the balance sheet.

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Voting Rights. Except as otherwise required by law, the Series G Preferred Stock does not have voting rights. However, as long as any shares of Series G Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then-outstanding shares of the Series G Preferred Stock, (i) alter or change adversely the powers, preferences or rights given to the Series G Preferred Stock or alter or amend the Certificate of Designation, amend or repeal any provision of, or add any provision to, the Charter or bylaws of the Company, or file any articles of amendment, certificate of designations, preferences, limitations and relative rights of any series of preferred stock, in each case if any such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series G Preferred Stock, regardless of whether any of the foregoing actions shall be by means of amendment to the Charter or by merger, consolidation, recapitalization, reclassification, conversion or otherwise, (ii) issue further shares of Series G Preferred Stock, (iii) prior to the earlier of stockholder approval of the Conversion or the six-month anniversary of issuance, consummate either: (A) any Fundamental Transaction (as in the Certificate of Designation) or (B) any stock sale to, or any merger, consolidation or other business combination of the Company with or into, another entity in which the stockholders of the Company immediately before such transaction do not hold at least a majority of the capital stock of the Company immediately after such transaction, or (iv) enter into any agreement with respect to any of the foregoing.

Liquidation Preference. The Series G Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company.

Dividend Rights. Holders of Series G Preferred Stock are entitled to receive dividends on shares of Series G Preferred Stock equal to, on an as-if-converted-to-Common-Stock basis, and in the same form as dividends actually paid on shares of the Common Stock.

Redemption. The shares of Series G Preferred Stock shall not be redeemable at the option of the Company or the holder thereof.

Trading Market. There is no established trading market for any of the Series G Preferred Stock, and we do not expect a market to develop. We do not intend to apply for a listing for any of the Series G Preferred Stock on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the Series G Preferred Stock will be limited.

At The Market Agreement with H.C. Wainwright

On May 26, 2021, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), as sales agent, pursuant to which the Company may issue and sell, from time to time, through Wainwright, shares of its Common Stock, and pursuant to which Wainwright may sell its Common Stock by any method permitted by law deemed to be an “at the market offering” as defined by Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company will pay Wainwright a commission of 3.0% of the aggregate gross proceeds from each sale of Common Stock. As of May 24, 2022, the Company was authorized to offer and sell up to $8.0 million of its Common Stock pursuant to the ATM Agreement. The Company did not utilize the ATM Agreement during the nine months ended September 30, 2024 or the year ended December 31, 2023.

July 2024 Inducement Offering

On July 10, 2024, the Company entered into a warrant exercise inducement offer letter (the “Inducement Letter”) with a holder (the “Holder”) of warrants to purchase shares of the Company’s common stock (the “Existing Warrants”) pursuant to which the Holder agreed to exercise for cash their Existing Warrants to purchase 1,762,674 shares of the Company’s common stock (the “Existing Warrant Shares”), in the aggregate, at a reduced exercised price of $1.09 per share, in exchange for the Company’s agreement to issue new warrants (the “Inducement Warrants”) on substantially the same terms as the Existing Warrants as described below, to purchase up to 3,525,348 shares of the Company’s common stock (the “Inducement Warrant Shares”). The Inducement Warrants will be exercisable upon the receipt of stockholder approval and may be exercised until the fifth anniversary of the date on which such stockholder approval is obtained. The Company received aggregate gross proceeds of approximately $1.9 million from the exercise of the Existing Warrants by the Holder and the sale of the Inducement Warrants. The Company engaged Roth Capital Partners, LLC (“Roth”) to act as its financial advisor in connection with the transactions summarized above and paid Roth approximately $0.1 million for its services, in addition to reimbursement for certain expenses.

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May 2024 Registered Direct Offering

On May 14, 2024, the Company completed a Registered Direct Offering (the “May 2024 Offering”) priced at market under Nasdaq rules, for an aggregate of (i) 275,000 shares of Common Stock, (ii) pre-funded warrants (the “May 2024 Pre-Funded Warrants”) to purchase up to an aggregate of 91,000 shares of Common Stock and (iii) common warrants (the “May 2024 Warrants”) to purchase up to an aggregate of 732,000 shares of Common Stock. The public offering price for each share of Common Stock and accompanying May 2024 Warrant to purchase one share of Common Stock was $2.95 per share. The May 2024 Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire when exercised in full. The May 2024 Warrants have an exercise price of $2.70 per share, are exercisable immediately and will expire six years from the initial exercise date.

The Company received gross proceeds of approximately $1.1 million less placement agent’s fees and other offering expenses of approximately $0.2 million.

March 2024 Registered Direct Offering

On March 6, 2024, the Company completed a Registered Direct Offering (the “March 2024 Offering”) priced at market under Nasdaq rules, for an aggregate of (i) 173,100 shares of Common Stock, (ii) pre-funded warrants (the “March 2024 Pre-Funded Warrants”) to purchase up to an aggregate of 352,525 shares of Common Stock and (iii) common warrants (the “March 2024 Warrants”) to purchase up to an aggregate of 525,625 shares of Common Stock. The public offering price for each share of Common Stock and accompanying March 2024 Warrant to purchase one share of Common Stock was $7.61 per share. The March 2024 Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire when exercised in full. The March 2024 Warrants have an exercise price of $7.48 per share, are exercisable immediately and will expire five years from the initial exercise date. The Company received gross proceeds of approximately $4.0 million less placement agent’s fees and other offering expenses of approximately $0.4 million.

September 2023 Inducement Offering

On September 14, 2023, the Company entered into warrant exercise inducement offer letters with certain holders (the “September 2023 Holders”) of warrants to purchase shares of the Company’s Common Stock (the “September 2023 Existing Warrants”) pursuant to which the September 2023 Holders agreed to exercise for cash their September 2023 Existing Warrants to purchase 294,101 shares of the Company’s Common Stock, in the aggregate, at a reduced exercised price of $8.60 per share, in exchange for the Company’s agreement to issue new warrants (the “September 2023 Inducement Warrants”) on substantially the same terms as the September 2023 Existing Warrants as described below, to purchase up to 588,204 shares of the Company’s Common Stock (the “September 2023 Inducement Warrant Shares”) and a cash payment of $2.50 per September 2023 Inducement Warrant Share which was paid in full upon the exercise of the September 2023 Existing Warrants (the “September 2023 Inducement Offering”). The Company received aggregate gross proceeds of approximately $4.0 million from the exercise of the September 2023 Existing Warrants by the Holders and the sale of the September 2023 Inducement Warrants. The Company engaged Roth Capital Partners, LLC (“Roth”) to act as its financial advisor in connection with the transactions summarized above and paid Roth approximately $0.2 million for its services.

July 2023 Offering

On July 21, 2023, the Company completed an offering (the “July 2023 Offering”) for an aggregate of (i) 30,500 shares of Common Stock, (ii) pre-funded warrants (the “July 2023 Pre-Funded Warrants”) to purchase up to an aggregate of 133,750 shares of Common Stock, and (iii) common warrants (the “July 2023 Warrants”) to purchase up to an aggregate of 328,500 shares of Common Stock. The public offering price for each share of Common Stock and accompanying July 2023 Warrant to purchase one share of Common Stock was $12.80 per share. The July 2023 Pre-Funded Warrants have an exercise price of $0.002 per share, are exercisable immediately and will expire when exercised in full. To date, pre-funded warrants have been exercised to purchase 133,750 shares of Common Stock. The July 2023 Warrants have an exercise price of $12.80 per share, are exercisable immediately and will expire five years from the initial exercise date. The Company received gross proceeds of approximately $2.1 million less placement agent’s fees and other offering expenses of approximately $0.3 million.

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June 2023 Inducement Offering

On June 13, 2023, the Company entered into warrant exercise inducement offer letters with certain holders (the “Holders”) of warrants to purchase shares of the Company’s Common Stock (the “Existing Warrants”) pursuant to which the Holders agreed to exercise for cash their Existing Warrants to purchase 86,216 shares of the Company’s Common Stock, in the aggregate, at a reduced exercised price of $23.00 per share, in exchange for the Company’s agreement to issue new warrants (the “Inducement Warrants”) on substantially the same terms as the Existing Warrants as described below, to purchase up to 172,433 shares of the Company’s Common Stock (the “Inducement Warrant Shares”) and a cash payment of $2.50 per Inducement Warrant Share which was paid in full upon the exercise of the Existing Warrants (the “June 2023 Inducement Offering”). The Company received aggregate gross proceeds of approximately $2.4 million from the exercise of the Existing Warrants by the Holders and the sale of the Inducement Warrants. The Company engaged Roth Capital Partners, LLC (“Roth”) to act as its financial advisor in connection with the transactions summarized above and paid Roth approximately $0.2 million for its services.

March 2023 Private Placement

On March 15, 2023, the Company completed a private placement offering (the “March 2023 Offering”) priced at market under Nasdaq rules, for an aggregate of (i) 6,400 shares of Common Stock, (ii) pre-funded warrants (the “March 2023 Pre-Funded Warrants”) to purchase up to an aggregate of 44,751 shares of Common Stock and (iii) common warrants (the “March 2023 Warrants”) to purchase up to an aggregate of 102,302 shares of Common Stock. The public offering price for each share of Common Stock and accompanying March 2023 Warrant to purchase one share of Common Stock was $78.20 per share. The March 2023 Pre-Funded Warrants have an exercise price of $0.002 per share, are exercisable immediately and will expire when exercised in full. The March 2023 Warrants have an exercise price of $73.20 per share, are exercisable immediately and will expire five years from the initial exercise date. The Company received gross proceeds of approximately $4.0 million less placement agent’s fees and other offering expenses of approximately $0.3 million.

Common Stock Issuances

Issuances for the Three Months Ended September 30, 2024

During the three months ended September 30, 2024, the Company issued 1,762,674 shares of Common Stock under the July 2024 Inducement Offering for which the Company received net proceeds of approximately $1.7 million.

During the three months ended September 30, 2024, the Company issued an aggregate of 38,182 shares of Common Stock upon the vesting of RSUs (See Note 12).

Issuances for the Nine Months Ended September 30, 2024

During the nine months ended September 30, 2024, the Company issued 173,100 and 275,000 shares of Common Stock under the March 2024 Offering and May 2024 Offering, respectively, for which the Company received net proceeds of approximately $4.5 million.

During the nine months ended September 30, 2024, the Company issued 1,762,674 shares of Common Stock under the July 2024 Inducement Offering for which the Company received net proceeds of approximately $1.7 million.

During the nine months ended September 30, 2024, the Company issued an aggregate of 36,830 shares of Common Stock with a value of $2.3 million in connection with the IMGX acquisition.

During the nine months ended September 30, 2024, the Company issued an aggregate of 18,475 shares of Common Stock with a value of $0.1 million to its financial advisors in connection with the IMGX acquisition.

During the nine months ended September 30, 2024, the Company issued an aggregate of 443,525 shares of Common Stock upon the exercise of pre-funded warrants issued at a par value of $0.0001 (See Note 11).

During the nine months ended September 30, 2024, the Company issued an aggregate of 27 shares of Common Stock upon the exchange of an aggregate of 30 shares of Series B Preferred Stock with a stated value of approximately $234,376 plus accrued dividends of approximately $70,429.

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During the nine months ended September 30, 2024, the Company issued an aggregate of 350,000 shares of its Common Stock to consultants with a grant date fair value of approximately $1,541,995 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense.

During the nine months ended September 30, 2024, the Company issued an aggregate of 121,335 shares of Common Stock upon the vesting of RSUs (See Note 12).

Issuances for the Three Months Ended September 30, 2023

During the three months ended September 30, 2023, the Company issued 30,500 shares of Common Stock under the July 2023 Offering for which the Company received net proceeds of approximately $1.8 million.

During the three months ended September 30, 2023, the Company issued 294,101 shares of Common Stock upon the exercise of an aggregate of 294,101 investor warrants for which the Company received net proceeds of approximately $3.7 million (See Note 11).

During the three months ended September 30, 2023, the Company issued an aggregate of 133,750 shares of Common Stock upon the conversion of pre-funded warrants issued at a par value of $0.0001.

During the three months ended September 30, 2023, the Company issued an aggregate of 22 shares of Common Stock upon the exchange of an aggregate of 24.22 shares of Series B Preferred Stock with a stated value of approximately $186,500 plus accrued dividends of approximately $43,300.

During the three months ended September 30, 2023, the Company issued an aggregate of 2,500 shares of its Common Stock to consultants with a grant date fair value of approximately $76,000 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense.

During the three months ended September 30, 2023, the Company issued an aggregate of 1,851 shares of Common Stock upon the vesting RSUs (See Note 12).

Issuances for the Nine Months Ended September 30, 2023

During the nine months ended September 30, 2023, the Company issued 6,400 shares of Common Stock under the March 2023 Offering for which the Company received net proceeds of approximately $3.7 million.

During the nine months ended September 30, 2023, the Company issued 86,216 shares of Common Stock upon the exercise of an aggregate of 86,216 investor warrants for which the Company received net proceeds of approximately $2.2 million.

During the nine months ended September 30, 2023, the Company issued 30,500 shares of Common Stock under the July 2023 Offering for which the Company received net proceeds of approximately $1.8 million.

During the nine months ended September 30, 2023, the Company issued 294,101 shares of Common Stock upon the exercise of an aggregate of 294,101 investor warrants for which the Company received net proceeds of approximately $3.7 million.

During the nine months ended September 30, 2023, the Company issued an aggregate of 199,974 shares of Common Stock upon the exercise of pre-funded warrants issued at a par value of $0.0001.

During the nine months ended September 30, 2023, the Company issued an aggregate of 26 shares of Common Stock upon the exchange of an aggregate of 28.45 shares of Series B Preferred Stock with a stated value of approximately $219,000 plus accrued dividends of approximately $49,500.

During the nine months ended September 30, 2023, the Company issued an aggregate of 2,500 shares of its Common Stock to consultants with a grant date fair value of approximately $76,000 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense.

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During the nine months ended September 30, 2023, the Company issued an aggregate of 3,854 shares of Common Stock upon the vesting of RSUs.

During the nine months ended September 30, 2023, the Company cancelled an aggregate of 148 shares of Common Stock in connection with the 1-for-7 reverse stock split on January 18, 2023.

Note 11 – Warrants

Warrant activity for the nine months ended September 30, 2024 and 2023 was as follows:


		Weighted		Weighted
		Average		Average
	Number of	Exercise Price		Remaining
	Warrants	Per Share		Term in Years
Outstanding and exercisable on January 1, 2024	1,779,780	$	19.29	4.99
Issued	5,226,498		1.87	4.85
Assumed from IMGX	127,680		3.48	8.47
Expired	(3)		52,500.00	—
Exercised	(2,206,199)		3.99	8.58
Warrants outstanding and exercisable on September 30, 2024	4,927,756	$	7.21	4.96

Warrants outstanding and exercisable on January 1, 2023	108,797	$	383.20	5.50
Issued	1,369,940		14.60	4.59
Expired	(4)		15,475.80	—
Exercised	(580,293)		19.20	4.72
Warrants outstanding and exercisable on September 30, 2023	898,440	$	47.60	4.89

As of September 30, 2024, the outstanding warrants expire from 2024 through 2033.

During the nine months ended September 30, 2024, the Company issued warrants to purchase 525,625 shares of the Company’s Common Stock and pre-funded warrants to purchase 352,525 shares of the Company’s Common Stock in connection with the March 2024 Offering, warrants to purchase 732,000 shares of the Company’s Common Stock and pre-funded warrants to purchase 91,000 shares of the Company’s Common Stock in connection with the May 2024 Offering , and warrants to purchase 3,525,348 shares of the Company’s Common Stock in connection with the July Inducement Offering (See Note 10). Additionally, the Company assumed warrants to purchase 127,680 shares of the Company’s Common Stock in connection with the IMGX acquisition.

During the nine months ended September 30, 2024, an investor exercised pre-funded warrants to purchase 443,525 shares of the Company's Common Stock and common stock warrants to purchase 1,762,674 shares of the Company's Common Stock in connection with previous offerings.

During the nine months ended September 30, 2023, the Company issued warrants to purchase 102,302 shares of the Company’s Common Stock and pre-funded warrants to purchase 44,751 shares of the Company’s Common Stock in connection with the March 2023 Offering, warrants to purchase 172,433 shares of the Company’s Common Stock in connection with the June 2023 Inducement Offering, warrants and pre-funded warrants to purchase 462,250 shares of the Company’s Common Stock in connection with the July 2023 Offering, and warrants to purchase 588,204 shares of the Company’s Common Stock in connection with the September 2023 Inducement Offering (See Note 10).

During the nine months ended September 30, 2023, an investor exercised pre-funded warrants to purchase 199,974 shares of the Company's Common Stock and common stock warrants to purchase 380,319 shares of the Company's Common Stock in connection with previous offerings.

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Note 12 – Equity Incentive Plan

The Company’s Board and stockholders adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “2014 Plan”), which took effect on May 12, 2014. The Company’s Board and stockholders adopted and approved the 2020 Omnibus Equity Incentive Plan (the “2020 Plan”), which took effect on September 11, 2020. From the adoption and approval of the 2020 Plan, no new awards have been or will be made under the 2014 Plan.

The 2020 Plan allows for the issuance of securities, including stock options to employees, Board members and consultants. The initial number of shares of Common Stock available for issuance under the 2020 Plan was 238 shares, which will, on January 1 of each calendar year, unless the Board decides otherwise, automatically increase to equal ten percent (10)% of the total number of shares of Common Stock outstanding on December 31 of the immediately preceding calendar year, calculated on an As Converted Basis. As Converted Shares include all outstanding shares of Common Stock and all shares of Common Stock issuable upon the conversion of outstanding preferred stock, warrants and other convertible securities, but will not include any shares of Common Stock issuable upon the exercise of options and other convertible securities issued pursuant to either the 2014 Plan, the 2020 Plan, or the IMGX Plan. The number of shares permitted to be issued as “incentive stock options” (“ISOs”) is 357 under the 2020 Plan.

On March 13, 2024, in connection with the IMGX acquisition, the Company assumed the IMGX Plan, including all 200,652 IMGX stock options immediately outstanding prior to the IMGX acquisition, with each becoming an option to purchase Common Stock, subject to adjustment. Such stock options were the only awards that had been made under the IMGX Plan as of the closing of the IMGX acquisition. The IMGX Plan was adopted and approved by the board of directors and stockholders of IMGX in 2021. Following the assumption of the IMGX Plan by the Company, no new awards have been or will be made under the IMGX Plan.

As of January 1, 2024, the number of shares of Common Stock available for issuance under the 2020 Plan automatically increased to 334,078 under the 2020 Plan’s evergreen provision.

As of September 30, 2024, there were an aggregate of 73 total shares available (but un-issuable) under the 2014 Plan, of which 27 are issued and outstanding, and 9 shares are reserved subject to issuance of restricted stock and RSUs.

As of September 30, 2024, there were an aggregate of 350,000 total shares available (but un-issuable) under the IMGX 2021 Plan, of which 200,652 are issued and outstanding.

As of September 30, 2024, 334,078 total shares were authorized under the 2020 Plan, of which 208,763 were issued and outstanding and 125,315 shares were available for potential issuances.

During the nine months ended September 30, 2024 and 2023, stock option activity under the 2014 Plan, 2020 Plan, and IMGX 2021 Plan was as follows:


		Average		Remaining
	Number	Exercise		Contract	Intrinsic
	of Shares	Price		Life (Years)	Value
Outstanding at January 1, 2024	426	$	6,103.81	8.53	$	—
Assumed from ImmunogenX	200,652		0.81	7.05		—
Expired	(15)		18,720.80	—		—
Outstanding at September 30, 2024	201,063	$	12.01	7.05	$	—
Exercisable at September 30, 2024	201,052	$	11.74	7.05	$	—

Outstanding at January 1, 2023	176	$	15,956.72	8.22	$	—
Granted	250		74.60	9.40		—
Outstanding at September 30, 2023	426	$	7,946.60	8.68	$	—
Exercisable at September 30, 2023	331	$	9,284.40	8.62	$	—

During the nine months ended September 30, 2024, the Company assumed fully vested options to purchase 200,652 shares of the Company’s Common Stock issued under the IMGX 2021 Plan. During the nine months ended September 30, 2023, the Board approved the grant of options to purchase 250 shares of the Company’s Common Stock pursuant to the 2020 Plan. In general, options granted under the 2020 Plan vest monthly over a 36-month period.

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For the nine months ended September 30, 2024 and 2023, the fair value of each option grant has been estimated on the date of grant using the Black-Scholes Option Pricing Model with the following weighted-average assumptions:


	2024		2023
Contractual term (in years)	7.6		6.5
Expected Volatility	110.35	%	98.80	%
Risk-free interest rate	4.20	%	4.08	%
Expected Dividend yield	0	%	0	%

Using the Black-Scholes Option Pricing Model, the estimated weighted average fair value of an option to purchase one share of common stock assumed during the nine months ended September 30, 2024 and 2023 was $6.32 and $61.00, respectively.

Restricted Stock and Restricted Stock Units

Restricted stock refers to shares of Common Stock subject to vesting based on certain service, performance, and market conditions. Restricted stock units (“RSUs”) refer to an award which constitutes a promise to grant shares of Common Stock at the end of a specified restriction period.

As of each September 30, 2024 and September 30, 2023, under the 2014 Plan, the Company had 1 share of restricted stock outstanding and an aggregate unrecognized restricted Common Stock expense of approximately $157,500, which will be recognized when vesting of certain milestones become probable.

During the nine months ended September 30, 2024 and 2023, RSU activity under the 2020 Plan was as follows:


		Weighted-Average		Weighted-Average
	Number	Grant Date		Remaining Recognition
	of Shares	Fair Value		Period (Years)
Non-vested Outstanding at January 1, 2024	52,271	$	4.31	9.96
Awarded	150,421		3.57	—
Vested	(133,401)		3.91	—
Cancelled	(52,225)		3.32	—
Non-vested Outstanding at September 30, 2024	17,066	$	3.86	0.85

Non-vested Outstanding at January 1, 2023	—		—	—
Awarded	8,012	$	124.00	—
Vested	(5,680)		124.00	—
Canceled	(508)		124.00	—
Non-vested Outstanding at September 30, 2023	1,824	$	124.00	0.25

During the nine months ended September 30, 2024 and 2023, the Board approved the grant of 150,421 and 8,012 RSUs, respectively. All grants of RSUs were pursuant to the 2020 Plan and typically vest quarterly over a one-year period. During the nine months ended September 30, 2024, 133,401 RSUs vested, of which 12,066 were issued in October 2024. During the nine months ended September 30, 2023, 5,680 RSUs vested, of which 1,826 were issued in October 2023.

The total stock-based compensation expense for employees and non-employees is included in the accompanying condensed consolidated statements of operations and as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development	$	9,550	$	34,847	$	60,045	$	111,092
General and administrative		174,096		228,483		526,851		803,258
Total stock-based compensation expense	$	183,646	$	263,330	$	586,896	$	914,350

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As of September 30, 2024, the Company had unrecognized stock-based compensation expense related to stock options and RSUs of approximately $78,000. Approximately $61,000 of this unrecognized expense will be recognized over the average remaining vesting term of the stock awards of 0.85 years. Approximately $17,000 of this unrecognized expense will vest upon achieving certain clinical and/or corporate milestones. The Company will recognize the expense related to these milestones when the milestones become probable. Stock-based compensation related to IMGX for the three and nine months ended September 30, 2024 of approximately $6,000 and $19,000, respectively, is included in discontinued operations on the statement of operations.

As of September 30, 2023, the Company had unrecognized stock-based compensation expense related to stock options and RSUs of approximately $0.6 million. Approximately $0.4 million of this unrecognized expense will be recognized over the average remaining vesting term of the stock awards of 0.66 years. Approximately $0.2 million of this unrecognized expense will vest upon achieving certain clinical and/or corporate milestones. The Company will recognize the expense related to these milestones when the milestones become probable.

Note 13 – Agreements

License Agreement with Sanofi

On September 13, 2023, the Company entered into a License Agreement with Sanofi, pursuant to which the Company received a license to obtain certain exclusive worldwide rights to develop and commercialize Capeserod, a selective 5-HT4 receptor partial agonist which the Company intends to repurpose and develop for gastrointestinal indications.

The Company paid Sanofi an upfront payment of $0.5 million in October 2023 and Sanofi will be eligible to receive up to $46.0 million in potential development and regulatory milestone payments and up to $235.0 million in potential commercial milestone payments. Sanofi will also be eligible to receive mid-to-high single-digit royalties on net sales, as well as a percentage of sublicense and transfer revenues with respect to Capeserod. Sanofi will also have a right of first refusal with respect to Capeserod out-licensing transactions.

The upfront payment of $0.5 million was recorded as research and development expense in the year ended December 31, 2023. Depending on the status of development at the time a contingent payment is recognized, the Company may determine that the payment should be expensed as research and development or be capitalized as an intangible asset. This determination will be based on the facts and circumstances that exist at the time a contingent payment is recognized.

The License Agreement shall expire on a country-by-country basis upon the later of: (i) the expiration of the last to expire valid claim of an applicable patent in such country covering such licensed product, (ii) the expiration of the regulatory exclusivity for such licensed product in the applicable country and (iii) the tenth anniversary of the date of first commercial sale of a licensed product in such country. Each party may terminate the License Agreement if the other party materially breaches its obligations under the License Agreement and fails to cure such material breach within 60 days from the date of such notice of breach, except in the case of payment breach, as to which the breaching party will have only a ten-day cure period. Sanofi may terminate the License Agreement upon any bankruptcy proceedings by the Company. The Company may terminate the License Agreement by providing Sanofi with at least 60 days prior written notice; provided, however, that Sanofi shall be entitled to any and all payments due and owed to Sanofi prior to the effective date of termination.

Note 14 – Leases

The Company leases its offices under operating leases which are subject to various rent provisions and escalation clauses.

The Company is a party to two real property operating leases for the rental of office space. The Company has office space of 3,472 square feet in Boca Raton, Florida that is used for its corporate headquarters with a term through August 31, 2026. The Company also has office space in Newport Beach, California with a term through April 30, 2025. In November 2024, the Company terminated its lease in Newport Beach, California.

The Company’s leases expire at various dates through 2026. The escalation clauses are indeterminable and considered not material and have been excluded from minimum future annual rental payments.

Lease expenses amounted to approximately $55,000 and $42,000 for the three months ended September 30, 2024 and 2023, respectively and $136,000 and $114,000 for the nine months ended September 30, 2024 and 2023, respectively.

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The weighted-average remaining lease term and weighted-average discount rate under operating leases as of September 30, 2024 are:


	September 30,
	2024
Lease term and discount rate
Weighted-average remaining lease term (years)	1.9
Weighted-average discount rate	7.00	%

Maturities of operating lease liabilities as of September 30, 2024, were as follows:


2024 (remainder of year)	$	21,815
2025		88,788
2026		60,593
Total lease payments		171,196
Less imputed interest		(11,529)
Present value of lease liabilities	$	159,667

Note 15 – Debt

Debt consists of the following:


			Related				Directors
			party				and Officer’s
	Revolving		promissory				Liability
	line of credit		notes		EIDL loan		Insurance		Total
Principal balance as of January 1, 2024	$	—	$	—	$	—	$	612,784	$	612,784
Additions		5,359,860		1,000,000		500,000		31,798		6,891,658
Payments		—		—		—		(644,582)		(644,582)
Debt discount		—		—		(456,123)		—		(456,123)
Reclassification to liabilities held for sale		(5,359,860)		(1,000,000)		(43,877)		—		(6,403,737)
Total debt as of September 30, 2024	$	—	$	—	$	—	$	—	$	—

Revolving line of credit

In connection with the IMGX acquisition, the Company assumed a revolving line of credit. In October 2022, ImmunogenX entered into a credit agreement, which allowed for a revolving line of credit (the “Revolver”) for borrowings up to $6.0 million, initially maturing on October 1, 2024, and bearing interest per annum of the prime rate plus 4.5%. The credit agreement was amended in September 2023 (the “First Amendment”) to increase the maximum borrowings of the Revolver to $7.5 million. The credit agreement was amended and restated on March 13, 2024 (the “Second Amendment”). Terms under the Second Amendment include an extended maturity date of September 13, 2025, interest per annum of the prime rate plus 6.0%, and no further draws on the line of credit after March 13, 2024. As of September 30, 2024, the Revolver and accrued interest has been reclassified to liabilities of disposal group held for sale (see Note 4).

Promissory notes

In connection with the IMGX acquisition, the Company assumed two promissory notes, one of which is with a related party. The notes are each in the amount of $0.5 million, accrue interest at a rate of the prime rate plus 4.5% per annum, and have a maturity date of September 30, 2025. As of September 30, 2024, the promissory notes and all accrued interest has been reclassified to liabilities of disposal group held for sale.

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EIDL loan

In connection with the IMGX acquisition, the Company assumed an Economic Injury Disaster Loan (“EIDL”) loan with a principal balance of $0.5 million bearing interest of 3.75% per annum, with interest payable monthly in arrears. The Company determined the loan has a fair value as of the assumption date of March 13, 2024 of $38,000, resulting in a discount of $462,000 which is amortized over the remaining life of the loan. All unpaid principal and interest are due at maturity on June 30, 2050. As of September 30, 2024, the EIDL loan and all accrued interest has been reclassified to liabilities of disposal group held for sale.

Directors and Officer’s Liability Insurance

On November 30, 2023, the Company entered into 9-month financing agreements for its directors and officer’s liability insurance, as well as other corporate insurances, in the amount of approximately $0.7 million that bears interest at an annual rate of 7.90%. In June 2024, approximately $32,000 was added to the financing agreement. Monthly payments going forward, including principal and interest, are approximately $0.1 million per month. The balance due under these financing agreements was $0 at September 30, 2024 and $0.6 million at December 31, 2023.

Note 16 – Net Loss per Common Share

Basic net loss per share is computed by dividing net loss available to Common Stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share reflect, in periods in which they have a dilutive effect, the impact of common shares issuable upon exercise of stock options and warrants and conversion of convertible debt that are not deemed to be anti-dilutive.

For the nine months ended September 30, 2024 stock options in the amount of 201,063 and warrants in the amount of 4,927,756 were excluded from the calculation of diluted net loss per share as they did not have a dilutive effect.

All shares of Common Stock that may potentially be issued in the future are as follows:


	September 30, 2024	September 30, 2023
	(unaudited)	(unaudited)
Series G convertible preferred stock	12,373,226	—
Common stock warrants	4,927,756	898,440
Stock options	201,063	426
RSUs not yet issued	17,066	1,824
Series B convertible preferred stock (1)	135	154
Restricted stock not yet issued	4	8
Total shares of common stock issuable	17,519,250	900,852

(1)	Series B convertible preferred stock is assumed to be converted at the rate of $32,340 per common share, which is the conversion price as of September 30, 2024.

Note 17 - Employee Benefit Plans

401(k) Plan

Since 2015, the Company has sponsored a multiple employer defined contribution benefit plan, which complies with Section 401(k) of the Internal Revenue Code covering substantially all employees of the Company. All employees are eligible to participate in the plan. Employees may contribute from 1% to 100% of their compensation and the Company matches an amount equal to 100% on the first 6% of the employee contribution and may also make discretionary profit-sharing contributions.

Employer contributions under this 401(k) plan amounted to approximately $17,000 and $21,000 for the three months ended September 30, 2024 and 2023, respectively, and approximately $84,000 and $68,000 for the nine months ended September 30, 2024 and 2023.

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Note 18 - Income Taxes

The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions. Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which those temporary differences are expected to be recovered or settled. Where applicable, the Company records a valuation allowance to reduce any deferred tax assets that it determines will not be realizable in the future.

The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position. These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution. Although the Company believes that it has adequately reserved for uncertain tax positions (including interest and penalties), it can provide no assurance that the final tax outcome of these matters will not be materially different. The Company makes adjustments to these reserves in accordance with the income tax accounting guidance when facts and circumstances change, such as the closing of a tax audit or the refinement of an estimate. To the extent that the final tax outcome of these matters is different than the amounts recorded, such differences will affect the provision for income taxes in the period in which such determination is made and could have a material impact on the Company’s financial condition and operating results. Carryforward attributes that were generated in tax years prior to those that remain open for examination may still be adjusted by relevant tax authorities upon examination if they either have been, or will be, used in a future period.

In applying the estimated annual effective tax rate approach prescribed under ASC 740 - 270 and based on present evidence and conclusions around the realizability of deferred tax assets, the Company determined that any deferred tax benefits related to the forecasted tax rate and pretax activity during the first half of 2024 and 2023 are neither more likely than not to be realized in the current year nor realizable as a deferred tax asset at the end of the year. Therefore, the appropriate amount of income tax benefit to recognize related to deferred tax assets generated during the nine months ended September 30, 2024 and 2023 is zero.

The Company’s effective income tax rate was approximately 73% and 0% for the nine months ended September 30, 2024 and 2023, respectively. The income tax provision for interim periods is determined using an estimate of the annual effective tax rate adjusted for discrete items. The Company’s effective tax rate for the nine months ended September 30, 2024 differs from the applicable statutory tax rate primarily due to the impact of the accounting for the IMGX Merger during the period, which resulted in the release of a portion of the valuation allowance that had previously been recorded against the deferred tax assets of the Company, resulting in a $10.6 million income tax benefit for the nine months ended September 30, 2024. The change in valuation allowance was determined based on the weight of available evidence as of the present reporting period and accounted for by the Company pursuant to ASC 805 - 740 - 30 - 3 in the Statement of Operations. The Company’s effective tax rate for the nine months ended September 30, 2023 differs from the applicable statutory tax rate primarily due to the full valuation allowance recorded against its deferred tax assets during the period.

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Note 19 - Subsequent Events

The Company evaluated subsequent events and transactions that occurred after the balance sheet date up to the date that the financial statements were available to be issued. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financial statements except for the items noted below.

Binding Term Sheet

In November 2024, the Company entered into a binding term sheet (the “Binding Term Sheet”) with Journey Therapeutics, Inc. (“Journey”), a life sciences company. Pursuant to the Binding Term Sheet, the Company will acquire 100% of the outstanding equity interests of Journey in return for 99% of the Company’s fully-diluted equity (the “Acquisition”). The Acquisition is subject to a number of conditions, including the completion of customary due diligence, negotiation of the definitive agreement, as well as approvals by the Company’s Board and the Company’s stockholders. Such definitive agreement will include a number of customary provisions, including without limitation, representations and warranties of Journey and the Company, restrictive covenants appliable to Journey and the Company and indemnification provisions. The Acquisition is also conditioned upon the completion of an equity financing providing net proceeds of at least $5.0 million, the effectiveness of a Form S-4 Registration Statement with regard to the Acquisition, to be filed with the SEC, and the shares of Common Stock of the combined company being approved for initial listing on Nasdaq.

Lease Termination

In November 2024, the Company terminated its lease in Newport Beach, California.

Share Issuances

In October 2024, the Company issued an aggregate of 12,066 shares of Common Stock upon the vesting of RSUs.

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

References in this report to “Entero,” “First Wave,” “AzurRx,” “Company,” “we,” “us,” “our,” or similar references mean Entero Therapeutics, Inc. and its subsidiaries on a consolidated basis. References to “AzurRx SAS” refer to Entero’s former wholly owned subsidiary through which we previously conducted our European operations. References to “FWB” refer to First Wave Bio, Inc. and references to “IMGX” refer to ImmunogenX, LLC, Entero’s wholly-owned subsidiaries. References to the “SEC” refer to the U.S. Securities and Exchange Commission.

Forward-Looking Statements

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements and the related notes included elsewhere in this interim report. Our consolidated financial statements have been prepared in accordance with U.S. GAAP. The following discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), including, without limitation, statements regarding our expectations, beliefs, intentions or future strategies that are signified by the words “expect,” “anticipate,” “intend,” “believe,” or similar language. All forward-looking statements included in this document are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements. Our business and financial performance are subject to substantial risks and uncertainties. Actual results could differ materially from those projected in the forward-looking statements. In evaluating our business, you should carefully consider the information set forth under the heading “Risk Factors” included in this Report and in our Annual Report filed on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 29, 2024. Readers are cautioned not to place undue reliance on these forward-looking statements.

Overview

We are engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (“GI”) diseases. Non-systemic therapies are non-absorbable drugs that act locally, i.e., in the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation.

Our therapeutic pipeline primarily consists of multiple late-stage clinical programs built around three proprietary technologies – the biologic Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency; Capeserod, a selective 5-HT4 receptor partial agonist which we are developing for the treatment of gastroparesis; and Niclosamide, an oral small molecule with anti-inflammatory properties for patients with inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease. We are currently focusing on our Adrulipase and Capeserod programs and are exploring strategic alternatives for our Niclosamide program.

In May 2024, we changed our name from First Wave Biopharma, Inc. to Entero Therapeutics, Inc.

In March 2024, we announced the closing of a merger with ImmunogenX, Inc. (“IMGX”) (the Company’s acquisition of IMGX, the “Merger”), a private, clinical-stage biopharmaceutical company founded in 2013, which is developing the biologic Latiglutenase for the treatment of celiac disease. IMGX is also developing CypCel, a metabolic marker compound that can measure the state of small-intestinal recovery of celiac patients undergoing gluten-free diets (“GFDs”).

We have initiated a plan to dispose of certain assets and liabilities of IMGX, including Latiglutenase and CypCel, within 12 months of the date of the Merger with IMGX. As of September 30, 2024, these were classified as assets and liabilities held for sale and due to the short period of time since the close of the Merger, are reported at their fair value less cost to sell. We determined that the discontinued operations of IMGX represents a strategic shift that will have a major effect on our operations and financial statements.

In December 2023, we announced that we have entered into a non-binding term sheet to sell our Niclosamide program. The non-binding term sheet includes a low seven-figure upfront payment to us for rights to Niclosamide, as well as economics related to future milestones and royalties. This transaction is not expected to move forward at this time.

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Recent Developments

March 2024 Registered Direct Offering

On March 6, 2024, we completed the March 2024 Offering priced at market under Nasdaq rules, for an aggregate of (i) 173,100 shares of Common Stock, (ii) pre-funded warrants to purchase up to an aggregate of 352,525 shares of Common Stock and (iii) common warrants to purchase up to an aggregate of 525,625 shares of Common Stock. The public offering price for each share of Common Stock and accompanying March 2024 Warrant to purchase one share of Common Stock was $7.61 per share. The March 2024 Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire when exercised in full. The March 2024 Warrants have an exercise price of $7.48 per share, are exercisable immediately and will expire five years from the initial exercise date. We received gross proceeds of approximately $4.0 million less placement agent’s fees and other offering expenses of approximately $0.4 million. The March 2024 Offering included customary registration rights, for registration under the Securities Act, of the shares underlying the warrants in the March 2024 Offering.

May 2024 Registered Direct Offering

On May 10, 2024, we announced that we entered into a Registered Direct Offering (the “May 2024 Offering”) likewise priced at market under Nasdaq rules. The May 2024 Offering was for an aggregate of (i) 275,000 shares of Common Stock, (ii) pre-funded warrants (the “May 2024 Pre-Funded Warrants”) to purchase up to an aggregate of 91,000 shares of Common Stock and (iii) common warrants (the “May 2024 Warrants”) to purchase up to an aggregate of 732,000 shares of Common Stock. The May 2024 Pre-Funded Warrants had the same exercise price and exercise terms as the March 2024 Pre-Funded Warrants. The public offering price for each share of Common Stock in the May 2024 Offering was $2.95, and the public offering price for each May 2024 Pre-Funded Warrant, was $2.9499. The May 2024 Warrants have an exercise price of $2.70 per share, are exercisable immediately and will expire six years from the initial exercise date. In this offering, we received gross proceeds of approximately $1.1 million less placement agent’s fees and other offering expenses.

In connection with the May 2024 Offering, we were obligated to file a registration statement with the SEC to register the shares underlying the warrants sold in the offering under the Securities Act, within 30 days of the closing of the May 2024 Offering and have such registration statement declared effective by the SEC within 60 days of such closing, or in the case of full review of the applicable registration statement by the SEC, within 120 days of such closing. If such registration statement is not so filed or declared effective, on each applicable monthly anniversary for which such registration even is not achieved or cured, we are required to pay to the holder an amount in cash, as partial liquidated damages and not as a penalty, equal to the product of 1.0% multiplied by the product of the most recent closing price of our Common Stock on the applicable event date, and the number of shares underlying such warrants, until the shares underlying such warrants are freely tradeable under Rule 144 of the Securities Act or we regain compliance with the registration rights. If we fail to pay partial liquidated damages required thereby within seven (7) days after the date payable, we are required to pay interest thereon at a rate of 12% per annum (or such lesser maximum amount that is permitted to be paid by applicable law) to the holder, accruing daily from the date such partial liquidated damages are due until such amounts, plus all such interest thereon, are paid in full. The partial liquidated damages provisions apply on a daily pro rata basis for any applicable portion of a month.

July 2024 Inducement Offering

On July 10, 2024, we entered into a warrant exercise inducement offer letter (the “Inducement Letter”) with a holder (the “Holder”) of warrants to purchase shares of our Common Stock (the “Existing Warrants”) pursuant to which the Holder agreed to exercise for cash their Existing Warrants to purchase 1,762,674 shares of our Common Stock (the “Existing Warrant Shares”), in the aggregate, at a reduced exercised price of $1.09 per share, in exchange for our agreement to issue new warrants (the “Inducement Warrants”) on substantially the same terms as the Existing Warrants as described below, to purchase up to 3,525,348 shares of our Common Stock (the “Inducement Warrant Shares”). The Inducement Warrants will be exercisable upon the receipt of stockholder approval and may be exercised until the fifth anniversary of the date on which such stockholder approval is obtained. We received aggregate gross proceeds of approximately $1.9 million from the exercise of the Existing Warrants by the Holder and the sale of the Inducement Warrants. We engaged Roth Capital Partners, LLC (“Roth”) to act as our financial advisor in connection with the transactions summarized above and paid Roth approximately $96,000 for its services, in addition to reimbursement for certain expenses.

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Nasdaq Continued Listing Requirements

On August 17, 2023, we received a letter from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that we were not in compliance with the $2.5 million minimum stockholders’ equity requirement for continued listing of our common stock on Nasdaq as set forth in Nasdaq Listing Rule 5550(b)(1) (the “Minimum Stockholder’s Equity Rule”). In that regard, we reported stockholders’ equity of $881,960 in our Quarterly Report on Form 10-Q for the period ended June 30, 2023 (we did not then, and do not now, meet the alternative compliance standards relating to the market value of listed securities of $35.0 million or net income from continuing operations of $0.5 million in the most recently completed fiscal year or in two of the last three most recently completed fiscal years). On April 1, 2024, we received a determination from the Staff that we are back in compliance with the Minium Stockholder’s Equity Rule and that the matter is closed.

On October 26, 2023, we received a notice from the Staff of Nasdaq indicating that in connection with an offering completed in July 2023 (the “July 2023 Offering”), we were not in compliance with Nasdaq’s shareholder approval requirements set forth in listing rule 5635(d), which requires prior shareholder approval for transactions, other than public offerings, involving the issuance of 20% or more of the pre-transaction shares outstanding at less than the Minimum Price, defined as a price that is the lower of: (i) the Nasdaq official closing Price (as reflected on Nasdaq.com) immediately preceding the signing of the binding agreement; or (ii) the average Nasdaq official Closing Price of the common stock (as reflected on Nasdaq.com) for the five trading days immediately preceding the signing of the binding agreement. On December 12, 2023, during the Special Meeting, our stockholders ratified our entry into the July 2023 Offering as we received the affirmative vote of the majority of the votes cast by shares of our common stock present or represented by proxy and entitled to vote at the Special Meeting. On March 19, 2024, we received a Letter of Reprimand from the Nasdaq Listing Qualifications Staff (the “Letter of Reprimand”) stating that, while we failed to comply with Nasdaq’s continued listing requirements, our violation of listing rule 5635 (d) does not appear to have been the result of a deliberate intent to avoid compliance, and as such, the Staff does not believe that delisting our securities is an appropriate sanction and that it is appropriate to close these matters by issuing the Letter of Reprimand.

On August 7, 2024, we notified the Staff of Nasdaq that, as the result of the resignations of two of our directors, we were no longer in compliance with Nasdaq Rule 5605(c)(2) (the “Audit Committee Rule”), which requires a Nasdaq-listed company to have an audit committee of the Board comprised of at least three independent directors meeting the eligibility requirements of the Audit Committee Rule. On August 8, 2024, our Board, having determined that both individuals meet the eligibility requirements of the Audit Committee Rule, appointed Chaitan Khosla and Alastair Riddell to the audit committee of the Board (the “Audit Committee”) to fill the vacancies on the Audit Committee created by the aforementioned resignations. Additionally, the Board appointed the existing Audit Committee member, Edward J. Borkowski, as chair of the Audit Committee. As a result of the appointments, the Audit Committee once again had three members, as required by the Audit Committee Rule.

On September 6, 2024, we received a letter from the Staff of Nasdaq indicating that, based upon the closing bid price of our Common Stock for the last 30 consecutive business days, we are not currently in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Notice”. The Notice has no immediate effect on the continued listing status of our common stock on The Nasdaq Capital Market, and, therefore, our listing remains fully effective. We are provided a compliance period of 180 calendar days from the date of the Notice, or until March 5, 2025, to regain compliance with the minimum closing bid requirement, pursuant to Nasdaq Listing Rule 5810(c)(3)(A). If at any time before March 5, 2025, the closing bid price of our common stock closes at or above $1.00 per share for a minimum of 10 consecutive business days, subject to Nasdaq’s discretion to extend this period pursuant to Nasdaq Listing Rule 5810(c)(3)(H), Nasdaq will provide written notification that we have achieved compliance with the minimum bid price requirement, and the matter would be resolved. If we do not regain compliance during the compliance period ending March 5, 2025, then Nasdaq may grant us a second 180 calendar day period to regain compliance, provided we meet the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the minimum closing bid price requirement, and notify Nasdaq of our intent to cure the deficiency.

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Rationalization Activities and Developments

As of December 31, 2023, we had 9 employees, which increased to 15 employees in March 2024 following the IMGX Merger. In connection with certain cost reduction measures we have taken, on July 16, 2024, we reduced our headcount to 11 employees, and Dr. Syage agreed to reduce his annual base salary to $66,560, effective July 1, 2024. On August 1, 2024, in order to further reduce costs and conserve resources, we approved the termination of all non-essential employees and are considering vacating the Boca Raton office.

On August 2, 2024, in connection with the reduction in workforce, the Board approve the termination of (i) the employment agreement with our Chief Executive Officer, James Sapirstein (the “Sapirstein Employment Agreement”), and (ii) the offer letter between us and our President, Jack Syage. In connection with the termination of the Sapirstein Employment Agreement, on August 2, 2024, we entered into a consulting agreement with Mr. Sapirstein (the “Sapirstein Consulting Agreement”), whereby he will continue to serve as our Chief Executive Officer, and pursuant to which Mr. Sapirstein will be paid $400 an hour monthly for services rendered to us. The Sapirstein Consulting Agreement has an initial term of six months, subject to early termination by either party for any reason at any time, and may be extended on a month-to-month basis upon mutual agreement after the expiration of the initial six-month term.

Additionally, on August 2, 2024, as part of the reduction in workforce described above, the Board approved the payout of unused vacation time for all employees accrued through August 1, 2024, including Mr. Sapirstein, Dr. Syage, and our Chief Financial Officer, Sarah Romano. We paid Mr. Sapirstein, Dr. Syage, and Ms. Romano $69,230, $1,920, and $45,590, respectively, to compensate for their unused vacation time accrued through August 1, 2024.

As a result of the rationalization, we have paused development of Latiglutenase, Adrulipase, Niclosamide, Capeserod, and any other non-essential research and development activities. We are exploring strategic alternatives, including a sale or wind-down of the IMGX entity, as well as other potential strategic options, including a merger, reverse merger, sale, wind-down, liquidation and dissolution or other strategic transaction, however our board of directors has not yet approved any strategic transactions. We are dependent on obtaining, and are continuing to pursue, the necessary funding from outside sources, including obtaining additional funding from the sale of securities in order to continue our operations. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be forced to delay, reduce or terminate our business activities.

Notice of Default and Acceleration

As previously disclosed in our Current Report on Form 8-K filed with the SEC on March 14, 2024, we acquired ImmunogenX in a merger transaction, the terms of which included, among other things, our wholly owned subsidiary, IMGX, assuming the debt of ImmunogenX. On August 2, 2024, IMGX received a Notice of Default and Acceleration (the “Notice”) relating to that certain Credit Agreement, dated as of October 3, 2022 (as amended, modified, supplemented or restated from time to time, the “Credit Agreement”) by and among Mattress Liquidators, Inc. (the “Lender”) and ImmunogenX.

The Notice informed IMGX that one or more events of default under the Credit Agreement (“Event of Defaults”) were existing and continuing. Such outstanding Events of Default include, among others, IMGX suffering an adverse change in its financial condition which would reasonably be expected to have a Material Adverse Effect (as defined in the Credit Agreement).

The Notice indicated that, as a result of the outstanding Events of Default, pursuant to the terms of Section 8.3 of the Credit Agreement, (a) the outstanding principal balance of the loan made under the Credit Agreement, all interest and fees related thereto, and all other outstanding obligations are accelerated and declared immediately due and payable, and that the Lender demands immediate payment of all obligations, and (b) the Lender is increasing the effective interest rate to the Default Rate (as defined in the Credit Agreement). The Credit Agreement affords IMGX thirty (30) days to cure Events of Default (the “Cure Period”), with a possible extension of an additional thirty (30) days, provided that in no event shall the Cure Period be greater than sixty (60) days in the aggregate. If IMGX is not able to cure the Events of Default within the Cure Period, IMGX may also be deemed to be in default of the stockholder notes ImmunogenX entered into with Jack Syage and Peter Felker as part of the acquisition of ImmunogenX by us (the “Stockholder Notes”), the entry into such notes having been previously disclosed by us on our Current Report on Form 8-K filed with the SEC on March 14, 2024. If IMGX is deemed to have defaulted under the Stockholder Notes, the holders of the Stockholder Notes may, at their option and upon notice to IMGX, declare the outstanding principal of, and all accrued interest on, the Stockholder Notes immediately due and payable.

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As of the date of the Notice, the aggregate outstanding obligations under the Credit Agreement were $6,997,583 (comprised of (i) $5,360,000 in respect of outstanding principal, (ii) $1,637,583 of accrued and unpaid interest, and (iii) other, presently unliquidated, amounts for fees and expenses (including legal fees) payable in accordance with the Credit Agreement and related documents). This outstanding amount does not include any additional obligations incurred following the date of the Notice (including additional interest, which shall continue to accrue on the outstanding obligations following the date of the Notice).

As previously disclosed in our Current Report on Form 8-K filed with the SEC on September 3, 2024, on August 29, 2024, after discussions with the Lender, ImmunogenX received a letter (the “Letter”) from the Lender informing ImmunogenX that at this time, the Lender is suspending the MAE Default. The Letter additionally provided that the Lender’s suspension of the MAE Default is not, and shall not be construed as, a waiver of the MAE Default and the Lender expressly reserves all rights with respect to its enforcement of the MAE Default.

Letter of Intent with Data Vault Holdings, Inc.

On September 9, 2024, we entered into the Letter of Intent with Data Vault Holdings, Inc. (“DVHI”) for the licensing of certain clinical trial software owned by DVHI and associated intellectual property (the “Assets”). The Letter of Intent contemplates a worldwide exclusive license to the Assets with the right to grant sublicenses, and a right of first refusal for the Company to fully acquire the Assets in exchange for the issuance of $250,000 of shares of the Company’s junior convertible preferred stock (the “Preferred Shares”) priced at a price per preferred share equal to 180% of the five (5) trading day Volume-Weighted Average Price (“VWAP”) of the Company’s common stock (the “Common Share Price”), immediately preceding the closing of the Proposed Transaction multiplied by 1,000 (the “Preferred Share Price”), and single digit royalties on net sales (the “Proposed Transaction”). Entry into definitive documentation for the Proposed Transaction will be conditioned upon the Company receiving no less than $500,000 of strategic investment (the “Strategic Investment”), with a target of ultimately securing up to $3.0 million of strategic investment with the assistance of DVHI. There can be no assurance that the Proposed Transaction will be completed on the terms contemplated in the Letter of Intent or otherwise.

Binding Term Sheet

On November 8, 2024, we entered into a binding term sheet (the “Binding Term Sheet”) with Journey Therapeutics, Inc. (“Journey”), a life sciences company. Pursuant to the Binding Term Sheet, we will acquire 100% of the outstanding equity interests of Journey in return for 99% of our fully-diluted equity (the “Acquisition”).

Following the close of the Acquisition, it is anticipated that Henry Ji, M.D., Ph.D., the Chief Executive Officer of Journey, will assume the roles of Chief Executive Officer and Chairman of the Board of Entero. Further, following the close of the Acquisition, the Board will be of a size to be determined jointly by Entero and Journey, with one to two members of the post-closing Board to be designated by Entero.

We anticipate adopting an equity incentive plan (the “Equity Plan”) for up to 15% of the outstanding shares of Common Stock of Entero at the time of the close of the Acquisition. We will also create an employee stock purchase plan for up to 1% of the outstanding shares of Common Stock of Entero at the time of the close of the Acquisition (the “ESPP”). The creation and adoption of the Equity Plan and the ESPP are subject to obtaining requisite Company stockholder, Board and committee approvals.

The Acquisition is subject to a number of conditions, including the completion of customary due diligence, negotiation of the definitive agreement, as well as approvals by our Board and our stockholders. Such definitive agreement will include a number of customary provisions, including without limitation, representations and warranties of Journey and Entero, restrictive covenants appliable to Journey and Entero and indemnification provisions. The Acquisition is also conditioned upon the completion of an equity financing providing net proceeds of at least $5.0 million, the effectiveness of a Form S-4 Registration Statement with regard to the Acquisition, to be filed with the SEC, and the shares of Common Stock of the combined company being approved for initial listing on Nasdaq.

Under the Binding Term Sheet, Journey and Entero are subject to an exclusivity period that is a minimum of 30 days, and such exclusivity shall continue after the 30-day period until a party delivers a notice of termination of exclusivity (the “Exclusivity Period”). During the Exclusivity Period, both parties are restricted from soliciting, negotiating or entering into any agreements with third parties for the sale of their respective businesses or material assets.

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Liquidity and Capital Resources

To date, we have not generated any revenues and have experienced net losses and negative cash flows from our activities.

As of September 30, 2024, we had cash and cash equivalents of approximately $0.4 million and had sustained cumulative losses attributable to common stockholders of approximately $190.1 million. Based on our cash on hand at September 30, 2024, we anticipate having sufficient cash to fund planned operations into December 2024. We believe that we will need to raise substantial additional capital in the near term to fund our continuing operations, satisfy existing and future obligations and liabilities, and otherwise support our working capital needs and business activities. The acceleration or reduction of cash outflows by management can significantly impact the timing for the need to raise additional capital to complete development of our products. In order to manage our operating costs, we have reduced headcount and paused development activities, and we are exploring strategic alternatives for the purpose of maximizing value of all of our stakeholders of the Company. We have been, and expect to continue to, explore various potential strategies available to us, including but not limited to raising capital, restructuring our indebtedness and identifying and evaluating potential strategic alternatives but there can be no assurance that these efforts will be successful, that we will be able to raise necessary capital on acceptable terms, reach agreement with our lenders, or that the strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. We are evaluating all potential strategic options, including a merger, reverse merger, sale, wind-down, liquidation and dissolution or other strategic transactions. As discussed above, in November 2024, we entered into a binding term sheet with Journey Therapeutics, Inc. pursuant to which we will acquire 100% of the outstanding equity interests of Journey in return for 99% of our fully-diluted equity, subject to a number of conditions. See Management’s Discussion and Analysis of Financial Condition and Results of Operations – Recent Developments. However, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stakeholder value or that we will make any cash distributions to our stockholders. Any failure in these efforts could force us to delay, limit or terminate our operations, make reductions in our workforce, discontinue our research and development programs, liquidate all or a portion of our assets or pursue other strategic alternatives, and/or seek protection under the provisions of the U.S. Bankruptcy Code.

We evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued. As described herein, if we are not able to obtain necessary capital, we may be required to terminate our operations, liquidate all or a portion of our assets and/or seek bankruptcy protection. As a result, management has concluded that its plans at this stage do not alleviate substantial doubt about our ability to continue as a going concern.

Under current Securities and Exchange Commission regulations, because our public float was less than $75.0 million at the relevant measurement period pursuant to General Instruction I.B.6. to Form S-3, the amount we can raise through primary public offerings of securities in any subsequent twelve-month period under our shelf registration statement is limited to an aggregate of one-third of our public float until such time, if any, as our public float is $75.0 million or more. Due to the late filing of our Form 10-Q for the quarter ended June 30, 2024, we are prohibited from registering shares under a Form S-3 for 12 months from the original filing due date, or August 14, 2025.

Our ability to issue securities is subject to market conditions. Each issuance under the shelf registration statements will require the filing of a prospectus supplement identifying the amount and terms of the securities to be issued.

Debt Obligations

Revolving line of credit

In connection with the IMGX acquisition, we assumed a revolving line of credit. In October 2022, IMGX entered into a credit agreement, which allowed for a revolving line of credit (the “Revolver”) for borrowings up to $6.0 million, maturing on October 1, 2024, and bearing interest per annum of the prime rate plus 4.5%. The credit agreement was amended in September 2023 (the “First Amendment”) to increase the maximum borrowings of the Revolver to $7.5 million. The credit agreement was amended and restated on March 13, 2024 (the “Second Amendment”). Terms under the Second Amendment include a maturity date of September 13, 2025, interest per annum of the prime rate plus 6.0%, and no further draws on the line of credit after March 13, 2024. As of September 30, 2024, the Revolver and accrued interest has been reclassified to liabilities of the disposal group held for sale.

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Promissory notes

In connection with the IMGX acquisition, we assumed two promissory notes, one of which is with a related party. The notes are each in the amount of $0.5 million, accrue interest at a rate of the prime rate plus 4.5% per annum, and have a maturity date of September 30, 2025. As of September 30, 2024, the promissory notes and all accrued interest has been reclassified to liabilities of the disposal group held for sale.

EIDL loan

In connection with the IMGX acquisition, we assumed an EIDL loan with a principal balance of $0.5 million bearing interest of 3.75% per annum, with interest payable monthly in arrears. All unpaid principal and interest are due at maturity on June 30, 2050. As of September 30, 2024, the EIDL loan and all accrued interest has been reclassified to liabilities of the disposal group held for sale.

Consolidated Results of Operations for the Three Months Ended September 30, 2024 and 2023

The following table summarizes our consolidated results of operations for the periods indicated:


	Three Months Ended
	September 30,				Increase
	2024		2023		(Decrease)
Operating expenses:
Research and development expenses	$	206,999	$	1,011,055	$	(804,056)
General and administrative expenses		1,685,608		2,422,082		(736,474)
Total operating expenses		1,892,607		3,433,137		(1,540,530)
Other expenses		2,645		1,021		1,624
Loss from continuing operations	$	(1,895,252)	$	(3,434,158)	$	(1,538,906)
Loss from discontinued operations		(685,719)		—		685,719
Net loss	$	(2,580,971)	$	(3,434,158)	$	(853,187)

Research and Development Expense

Research and development expenses include expenses primarily relating to the development of our Adrulipase and Capeserod drug candidates.

Research and development expenses for the three months ended September 30, 2024 totaled approximately $0.2 million, a decrease of approximately $0.8 million, or 80%, over the approximately $1.0 million recorded for the three months ended September 30, 2023.

The approximately $0.8 million decrease in total research and development expenses was primarily attributable to a decrease of $0.5 million related to the September 2023 up-front payment to Sanofi per the executed license agreement for Capeserod, as well as a $0.2 million decrease in clinical trial related expenses and a $0.1 million decrease in personnel costs.

We expect research and development expenses to decrease during the remainder of this fiscal year as we conserve cash.

General and Administrative Expense

General and administrative expenses include expenses primarily relating to our overall operations and being a public company, including personnel, legal and financial professional services, insurance, corporate communications and investor relations, listing and compliance related costs, rent, and expenses associated with obtaining and maintaining intellectual property and patents, among others.

General and administrative expenses for the three months ended September 30, 2024 totaled approximately $1.7 million, a decrease of approximately $0.7 million, or 30% over the approximately $2.4 million recorded for the three months ended September 30, 2023.

The approximately $0.7 million decrease in total general and administrative expenses was primarily attributable to a decrease of $0.5 million in public company costs and investor relations and $0.1 million in share-based compensation.

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We expect general and administrative expenses to decrease during the remainder of this fiscal year as we conserve cash.

Other Expenses

Other expenses for the three months ended September 30, 2024 and 2023 were insignificant.

Loss from discontinued operations

Loss from discontinued operations for the three months ended September 30, 2024 of $0.7 million represents expenses related to the disposal group that was classified as held for sale as of September 30, 2024.

Net Loss

As a result of the factors above, our net loss for the three months ended September 30, 2024 totaled approximately $2.6 million, a decrease of approximately $0.9 million, or 25%, over the net loss of approximately $3.4 million recorded for the three months ended September 30, 2023.

Consolidated Results of Operations for the Nine Months Ended September 30, 2024 and 2023

The following table summarizes our consolidated results of operations for the periods indicated:


	Nine Months Ended
	September 30,				Increase
	2024		2023		(decrease)
Operating expenses:
Research and development expenses	$	882,522	$	3,725,833	$	(2,843,311)
General and administrative expenses		13,535,241		7,951,373		5,583,868
Total operating expenses		14,417,763		11,677,206		2,740,557
Other expenses		7,184		16,837		(9,653)
Loss before income tax benefit		(14,424,947)		(11,694,043)		2,730,904
Income tax benefit		10,604,640		—		10,604,640
Loss from continuing operations	$	(3,820,307)	$	(11,694,043)	$	(7,873,736)
Loss from discontinued operations		(2,000,760)		—		2,000,760
Net loss	$	(5,821,067)	$	(11,694,043)	$	(5,872,976)

Research and Development Expenses

Research and development expenses include expenses primarily relating to the development of our Adrulipase and Capeserod drug candidates.

Research and development expenses for the nine months ended September 30, 2024 totaled approximately $0.9 million, a decrease of approximately $2.8 million, or 76%, over the approximately $3.7 million recorded for the nine months ended September 30, 2023.

The decrease in research and development expenses of $2.8 million was primarily attributable to decreases of approximately $2.0 million in clinical related expenses primarily related to our Phase 2b Adrulipase SPAN clinical trial which occurred during the nine months ended September 30, 2023 and a decrease of $0.5 million related to the September 2023 up-front payment due to Sanofi per the executed license agreement for Capeserod.

We expect research and development expenses to decrease during the remainder of this fiscal year as we conserve cash.

General and Administrative Expenses

General and administrative expenses include expenses primarily relating to our overall operations and being a public company, including personnel, legal and financial professional services, insurance, corporate communication and investor relations, listing and compliance related costs, rent, and expenses associated with obtaining and maintaining intellectual property and patents, among others.

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General and administrative expenses for the nine months ended September 30, 2024 totaled approximately $13.5 million, an increase of approximately $5.6 million, or 70% over the approximately $7.9 million recorded for the nine months ended September 30, 2023.

The increase in general and administrative expenses of $5.6 million was primarily due to $4.0 million of non-cash expense recorded for financial advisor fees related to the IMGX acquisition, $1.5 million in share-based compensation for consultants, and an increase of $0.9 million in legal fees and professional fees related to the IMGX acquisition. The increase was partially offset by a decrease of $0.5 million in public company costs and investor relations.

We expect general and administrative expenses to decrease during the remainder of this fiscal year as we conserve cash.

Other Expenses

Other expenses for the nine months ended September 30, 2024 and 2023 were insignificant.

Income Tax Benefit

A tax benefit of approximately $10.6 million was recorded in the nine months ended September 30, 2024 due to the release of a portion of our valuation allowance in connection with the IMGX Merger of $14.9 million, partially offset by an increase in our valuation allowance of $4.3 million related to the reclassification of the IMGX IPR&D to held for sale.

Loss from discontinued operations

Loss from discontinued operations for the nine months ended September 30, 2024 of $2.0 million represents expenses related to the disposal group that was classified as held for sale as of September 30, 2024.

Net Loss

As a result of the factors above, our net loss for the nine months ended September 30, 2024 totaled approximately $5.8 million, a decrease of approximately $5.9 million, or 50%, over the approximately $11.7 million net loss recorded for the nine months ended September 30, 2023.

Cash Flows for the Nine Months Ended September 30, 2024 and 2023

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


	Nine Months Ended
	September 30,
	2024		2023
Net cash (used in) provided by:
Operating activities	$	(9,046,305)	$	(8,938,474)
Investing activities		88,169		—
Financing activities		5,613,152		10,867,899
Net (decrease) increase in cash, cash equivalents and restricted cash	$	(3,344,984)	$	1,929,425

Operating Activities

Net cash used in operating activities during the nine months ended September 30, 2024 of approximately $9.0 million was primarily attributable to our non-cash change in deferred tax valuation allowance of $10.6 million and our net loss of $5.8 million, partially offset by other non-cash expenses totaling approximately $7.4 million, mainly related to stock issued to our financial advisors in connection with the IMGX acquisition of $4.0 million, common stock granted to consultants of $1.5 million, and stock-based compensation of $0.6 million, as well as a decrease in prepaid expenses of $0.9 million.

Net cash used in operating activities during the nine months ended September 30, 2023 of approximately $8.9 million was primarily attributable to our net loss of approximately $11.7 million; partially offset by a decrease in prepaid expenses of approximately $1.3 million, non-cash expenses of approximately $1.0 million, mainly related to stock-based compensation and common stock issued to consultants; and a net increase in accrued expenses and accounts payable of approximately $0.4 million.

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Investing Activities

Net cash provided by investing activities during the nine months ended September 30, 2024 of approximately $0.1 million was due to the net cash acquired in the acquisition of IMGX.

Financing Activities

Net cash provided by financing activities of approximately $5.6 million for the nine months ended September 30, 2024 was primarily due to net proceeds of approximately $4.5 million from the March 2024 and May 2024 registered direct offerings and $1.7 million from the July Inducement offering, partially offset by approximately $0.6 million of cash repayments of the note payable financing for corporate insurances.

Net cash provided by financing activities of approximately $10.9 million for the nine months ended September 30, 2023 was due to the net proceeds of approximately $5.9 million from the exercise of warrants, the net proceeds of approximately $5.5 million from the March 2023 and July 2023 offerings of our common stock, partially offset by repayments of approximately $0.6 million related to the note payable.

Critical Accounting Policies and Estimates

Our accounting policies are essential to understanding and interpreting the financial results reported on the consolidated financial statements. The significant accounting policies used in the preparation of our consolidated financial statements are summarized in Note 2 to the consolidated financial statements and notes thereto found in our Annual Report on Form 10-K for the year ended December 31, 2023. Certain of those policies are considered to be particularly important to the presentation of our financial results because they require us to make difficult, complex or subjective judgments, often as a result of matters that are inherently uncertain.

During the nine months ended September 30, 2024, there were no material changes to matters discussed under the heading “Critical Accounting Policies and Significant Judgments and Estimates” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS

Not applicable.

ITEM 4. CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

As required by Rule 13a - 15(b) under the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) our Chief Executive Officer (“CEO”) and our Chief Financial Officer (“CFO”) conducted an evaluation as of the end of the period covered by this Quarterly Report on Form 10 - Q, of the effectiveness of our disclosure controls and procedures as defined in Rules 13a - 15(e) and 15d - 15(e) under the Exchange Act. Based on that evaluation, our CEO and our CFO each concluded that our disclosure controls and procedures are effective to provide reasonable assurance that information required to be disclosed in the reports that we file or submit under the Exchange Act, (i) is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and (ii) is accumulated and communicated to our management, including our CEO and our CFO, as appropriate to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a - 15(d) or 15d - 15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10 - Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II

OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

None.

ITEM 1A. RISK FACTORS

Except as described below, there have been no material changes in or additions to the risk factors included in our Quarterly Report on Form 10-Q for the period ended September 30, 2024 or our Annual Report on Form 10-K for the year ended December 31, 2023.

There is substantial doubt about our ability to continue as a “going concern,” and we will require substantial additional funding to finance our near- and long-term operations. If we are unable to raise additional capital, we have delayed, and could be forced to further delay, reduce or terminate certain of our products or other operations.

We have incurred substantial operating losses since inception and expect to continue to incur significant operating losses for the foreseeable future. As of September 30, 2024, we had cash and cash equivalents of approximately $0.4 million and have sustained cumulative losses attributable to common stockholders of approximately $190.1 million.

Based on our cash on hand at November 13, 2024, we anticipate having sufficient cash to fund planned operations into December 2024. The acceleration or reduction of cash outflows by management can significantly impact the timing for the need to raise additional capital to complete development of our products. We believe that we will need to raise substantial additional capital in the near term to fund our continuing operations, satisfy existing and future obligations and liabilities, and otherwise support our working capital needs and business activities. In order to manage our operating costs, we have paused development activities for Latiglutenase, Capeserod and Adrulipase, and we are exploring strategic alternatives for Latiglutenase and Niclosamide.

We have not yet achieved profitability and anticipate that we will continue to incur net losses for the foreseeable future. We expect that our expenses will continue to grow and, as a result, we will need to generate significant product revenues to achieve profitability. We may never achieve profitability. Therefore, we are dependent on obtaining, and are continuing to pursue, the necessary funding from outside sources, including obtaining additional funding from the sale of securities in order to continue our operations. We are actively working to obtain additional funding. However, there are currently no commitments in place for further financing nor is there any assurance that such financing will be available to us on favorable terms, if at all. We believe these conditions may raise substantial doubt about our ability to continue as a going concern. If we are unable to secure additional capital, we may be required to delay or curtail any future development of products, and we may take additional measures to reduce expenses in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. This would negatively impact our business and operations, which would likely cause the price of our Common Stock to decline or ultimately force us to cease our operations.

We have recently rationalized our operations and may further rationalize or terminate our operations if we cannot obtain sufficient capital.

We are dependent on obtaining, and are continuing to pursue, the necessary funding from outside sources, including obtaining additional funding from the sale of securities in order to continue our operations. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be forced to delay, reduce or terminate our business activities.

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On August 2, 2024, in connection with the reduction in workforce, the Board approve the termination of (i) the employment agreement with our Chief Executive Officer, James Sapirstein (the “Sapirstein Employment Agreement”), and (ii) the offer letter between us and our President, Jack Syage. In connection with the termination of the Sapirstein Employment Agreement, on August 2, 2024, we entered into a consulting agreement with Mr. Sapirstein (the “Sapirstein Consulting Agreement”), whereby he will continue to serve as our Chief Executive Officer, and pursuant to which Mr. Sapirstein will be paid $400 an hour monthly for services rendered to us. The Sapirstein Consulting Agreement has an initial term of six months, is subject to early termination by either party for any reason at any time, and may be extended on a month-to-month basis upon mutual agreement after the expiration of the initial six-month term.

As a result of the rationalization, we have paused research and development activities for our Latiglutenase, Adrulipase and Capeserod product candidates and any other non-essential research and development activities and have paused or terminated third party service arrangements related thereto. We are exploring strategic alternatives for Niclosamide and are evaluating all potential strategic options, including a merger, reverse merger, sale, wind-down, liquidation and dissolution or other strategic transaction, including a potential sale or wind-down of the IMGX assets and liabilities. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stakeholder value or that we will make any cash distributions to our stockholders. Any failure in these efforts could force us to delay, limit or terminate our operations, make reductions in our workforce, discontinue our research and development programs, liquidate all or a portion of our assets or pursue other strategic alternatives, and/or seek protection under the provisions of the U.S. Bankruptcy Code.

Due to the significant resources required for the development of our product candidates, we must prioritize development of certain product candidates and/or certain disease indications, and deprioritize others. We may expend our limited resources, as they become available, on candidates or indications that do not yield a successful product and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Our goal is to develop a pipeline of product candidates to treat GI and other diseases. Due to the significant resources required for the development of product candidates, we must focus our attention and resources on specific diseases and/or indications and decide which product candidates to pursue and the amount of resources to allocate to each. We intend to focus our resources, as they become available, on the development of our product candidates Adrulipase and Capeserod.

Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular product candidates or therapeutic areas may not lead to the development of any viable commercial product and may divert resources away from better opportunities. Similarly, any decision to delay, terminate or collaborate with third parties in respect of certain programs or product candidates may subsequently prove to be suboptimal and could cause us to miss valuable opportunities. If we make incorrect determinations regarding the viability or market potential of any of our programs or product candidates or misread trends in the GI, CF, CP, COVID-19, ICI-AC or biotechnology industry, our business, financial condition and results of operations could be materially adversely affected. As a result, we may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with other product candidates or other diseases and indications that may later prove to have greater commercial potential than those we choose to pursue, or relinquish valuable rights to such product candidates through collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain development and commercialization rights.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Sale of Unregistered Securities

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

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ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

None.

ITEM 6. EXHIBITS

(b)

Exhibits

Exhibit No.		Description
3.1		Amended and Restated Certificate of Incorporation of the Registrant, as amended (incorporated by reference to Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on October 21, 2024).
3.2		Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 of the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 15, 2022).
4.1		Form of Inducement Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 11, 2024).
10.1		Form of Inducement Letter (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 11, 2024).
10.2†		Consulting Agreement, dated August 2, 2024, by and between the Company and James Sapirstein (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on August 7, 2024).
31.1*		Certification of the Principal Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*		Certification of the Principal Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**		Certification of the Principal Executive Officer and Principal 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 Document
101.CAL*		Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*		Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*		Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*		Inline XBRL Taxonomy Extension Presentation Linkbase Document
104		Cover Page Interactive Data File (embedded within the Inline XBRL Document and included in Exhibit 101)

*filed herewith

**furnished, not filed, herewith

† Indicates a management contract or compensation plan, contract or arrangement.

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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.

	ENTERO THERAPEUTICS, INC.

	By	/s/ James Sapirstein
		James Sapirstein
		Chief Executive Officer and Chairman
		(Principal Executive Officer)

	By	/s/ Sarah Romano
		Sarah Romano
		Chief Financial Officer
Date: November 13, 2024		(Principal Financial and Accounting Officer)

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EXHIBIT 31.1

CERTIFICATION PURSUANT TO RULE 13A-14 OF THE SECURITIES EXCHANGE ACT OF 1934

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, James Sapirstein, Chief Executive Officer of Entero Therapeutics, Inc. (the “Company”), certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of the Company;

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;

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:

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;

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

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

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):

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

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.

Date: November 13, 2024	/s/ James Sapirstein
	James Sapirstein
	Chief Executive Officer
	(Principal Executive Officer)

EXHIBIT 31.2

CERTIFICATION PURSUANT TO RULE 13A-14 OF THE SECURITIES EXCHANGE ACT OF 1934

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Sarah Romano, Chief Financial Officer of Entero Therapeutics, Inc. (the “Company”), certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of the Company;

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;

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):

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.

Date: November 13, 2024	/s/ Sarah Romano
	Sarah Romano
	Chief Financial Officer
	(Principal Financial and Accounting Officer)

EXHIBIT 32.1

CERTIFICATION 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 Entero Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, James Sapirstein, Chief Executive Officer of the Company, and Sarah Romano, Chief Financial Officer of the Company, each 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; and

(2)

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

Date: November 13, 2024	/s/ James Sapirstein
	James Sapirstein
	Chief Executive Officer
	(Principal Executive Officer)

	/s/ Sarah Romano
	Sarah Romano
	Chief Financial Officer
	(Principal Financial and Accounting Officer)

Document And Entity Information - shares	9 Months Ended
Document And Entity Information - shares	Sep. 30, 2024	Nov. 08, 2024
Document And Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Entity File Number	001-37853
Entity Registrant Name	Entero Therapeutics, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	46-4993860
Entity Address, Address Line One	777 Yamato Road, Suite 502
Entity Address, City or Town	Boca Raton
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	33431
City Area Code	561
Local Phone Number	589-7020
Entity Information, Former Legal or Registered Name	First Wave BioPharma, Inc.
Title of 12(b) Security	Common stock, par value $0.0001 per share
Trading Symbol	ENTO
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		4,754,030
Entity Central Index Key	0001604191
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Amendment Flag	false

Condensed Consolidated Balance Sheets - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Current Assets:
Cash and cash equivalents	$ 366,788	$ 3,711,770
Prepaid expenses	305,461	1,244,466
Assets of disposal group held for sale	83,170,009
Total Current Assets	83,842,258	4,956,236
Property, equipment, and leasehold improvements, net		14,565
Other Assets:
Restricted cash	21,520	21,522
Goodwill	1,684,182	1,684,182
Operating lease right-of-use assets	144,410	195,440
Deposits	128,250	11,250
Total Other Assets	1,978,362	1,912,394
Total Assets	85,820,620	6,883,195
Current Liabilities:
Accounts payable	2,214,946	554,277
Accrued expenses	219,193	825,290
Accrued dividend payable	1,258,450	1,069,616
Note payable		612,784
Operating lease liabilities	79,454	67,111
Other current liabilities		4,239
Liabilities of disposal group held for sale	11,918,261
Total Current Liabilities	15,690,304	3,133,317
Non-current operating lease liabilities	80,213	146,949
Total Liabilities	15,770,517	3,280,266
Mezzanine Equity:
Total Mezzanine Equity	61,681,100
Stockholders' Equity:
Common stock - Par value $0.0001 per share; 100,000,000 shares authorized; 4,741,964 and 1,560,998 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	474	156
Additional paid-in capital	198,518,268	187,931,445
Accumulated deficit	(190,149,739)	(184,328,672)
Total Stockholders' Equity	8,369,003	3,602,929
Total Liabilities, Mezzanine Equity and Stockholders' Equity	85,820,620	6,883,195
Series G redeemable preferred stock
Mezzanine Equity:
Total Mezzanine Equity	61,681,100
Series B preferred stock
Stockholders' Equity:
Preferred stock	0	0
Series C Preferred Stock
Stockholders' Equity:
Preferred stock	0	0
Series D Preferred Stock
Stockholders' Equity:
Preferred stock	0	0
Series E Preferred Stock
Stockholders' Equity:
Preferred stock	0	0
Series F Preferred Stock
Stockholders' Equity:
Preferred stock	$ 0	$ 0

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized (in shares)	100,000,000	100,000,000
Common stock, shares issued (in shares)	4,741,964	1,560,998
Common stock, shares outstanding (in shares)	4,741,964	1,560,998
Preferred stock, par value (in dollars per share)	$ 0.0001
Preferred stock, shares authorized (in shares)	10,000,000
Series G redeemable preferred stock
Temporary Equity, Par or Stated Value Per Share	$ 0.0001	$ 0.0001
Temporary Equity, Shares Authorized	13,000	13,000
Temporary Equity, Shares Issued	12,373.226	0
Temporary Equity, Shares Outstanding	12,373.226	0
Series B preferred stock
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized (in shares)	5,194.81	5,194.81
Preferred stock, shares issued (in shares)	484.52	514.96
Preferred stock, shares outstanding (in shares)	484.52	514.96
Series C Preferred Stock
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized (in shares)	75,000	75,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Series D Preferred Stock
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized (in shares)	150	150
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Series E Preferred Stock
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized (in shares)	150	150
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Series F Preferred Stock
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized (in shares)	7,000	7,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0

Condensed Consolidated Statements of Operations (unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Operating expenses:
Research and development expenses	$ 206,999	$ 1,011,055	$ 882,522	$ 3,725,833
General and administrative expenses	1,685,608	2,422,082	13,535,241	7,951,373
Total operating expenses	1,892,607	3,433,137	14,417,763	11,677,206
Loss from operations	(1,892,607)	(3,433,137)	(14,417,763)	(11,677,206)
Other expenses:
Interest income (expense), net	229	(1,021)	675	(13,108)
Other expense, net	(2,874)		(7,859)	(3,729)
Total other expenses	(2,645)	(1,021)	(7,184)	(16,837)
Loss before income tax benefit	(1,895,252)	(3,434,158)	(14,424,947)	(11,694,043)
Income tax benefit			10,604,640
Net loss from continuing operations	(1,895,252)	(3,434,158)	(3,820,307)	(11,694,043)
Loss from discontinued operations	(685,719)		(2,000,760)
Net loss	(2,580,971)	(3,434,158)	(5,821,067)	(11,694,043)
Preferred stock dividends	(84,632)	(49,292)	(150,776)	(231,047)
Net loss applicable to common shareholders	$ (2,665,603)	$ (3,483,450)	$ (5,971,843)	$ (11,925,090)
Weighted average shares outstanding, basic (in shares)	4,552,019	378,301	3,005,055	188,175
Weighted average shares outstanding, diluted (in shares)	4,552,019	378,301	3,005,055	188,175
Loss per share, basic	$ (0.59)	$ (9.21)	$ (1.99)	$ (63.37)
Loss per share, diluted	(0.59)	$ (9.21)	(1.99)	$ (63.37)
Loss per share from discontinued operations, basic	(0.15)		(0.67)
Loss per share from discontinued operations, diluted	$ (0.15)		$ (0.67)

Condensed Consolidated Statements of Mezzanine Equity and Changes in Stockholders' Equity (unaudited) - USD ($)	Issuance of Common Stock, Pre Funded Warrants in July 2023 Offering Common Stock	Issuance of Common Stock, Pre Funded Warrants in July 2023 Offering Additional Paid-in Capital	Issuance of Common Stock, Pre Funded Warrants in July 2023 Offering	July 2024 Inducement Offering Common Stock	July 2024 Inducement Offering Additional Paid-in Capital	July 2024 Inducement Offering	June 2023 inducement offering Common Stock	June 2023 inducement offering Additional Paid-in Capital	June 2023 inducement offering	September 2023 inducement offering Common Stock	September 2023 inducement offering Additional Paid-in Capital	September 2023 inducement offering	Private placement Common Stock	Private placement Additional Paid-in Capital	Private placement	Convertible preferred stock Series G Convertible Preferred Stock	Convertible preferred stock Series B Convertible Preferred Stock	Common Stock	Additional Paid-in Capital	Accumulated Deficit	Total
Balance at the beginning (in shares) at Dec. 31, 2022																	550	49,750
Balance at the beginning at Dec. 31, 2022																		$ 5	$ 171,275,836	$ (168,533,689)	$ 2,742,152
Issuance of common stock, pre-funded warrants and warrants in registered direct offerings and private placement, net of issuance costs	$ 3	$ 1,833,924	$ 1,833,927										$ 1	$ 3,690,972	$ 3,690,973
Issuance of common stock, pre-funded warrants and warrants in registered direct offerings and private placement, net of issuance costs (in shares)	30,500												6,400
Exercise of pre-funded warrants into Common Stock																		$ 21	636		657
Exercise of pre-funded warrants into Common Stock (in shares)																		199,974
Issuance of common stock in connection with the exercise of warrants, net of offering costs							$ 8	$ 2,239,057	$ 2,239,065	$ 29	$ 3,706,742	$ 3,706,771
Issuance of Common Stock in connection with the exercise of warrants, net of offering costs (in shares)							86,216			294,101
Deemed dividend of Series B preferred stock																			(231,047)		(231,047)
Conversion of Series B preferred shares into common stock (in shares)																	(28)	26
Common stock issued to consultants																			76,000		76,000
Common stock issued to consultants (in shares)																		2,500
Issuance of common stock from RSU vest (in shares)																		3,854
Effect of cancelled shares from the reverse stock split (in shares)																		(147)
Stock-based compensation																			914,350		914,350
Net loss																				(11,694,043)	(11,694,043)
Balance at the end (in shares) at Sep. 30, 2023																	522	673,174
Balance at the end at Sep. 30, 2023																		$ 67	183,506,470	(180,227,732)	3,278,805
Balance at the beginning (in shares) at Jun. 30, 2023																	546	210,450
Balance at the beginning at Jun. 30, 2023																		$ 21	177,675,513	(176,793,574)	881,960
Issuance of common stock, pre-funded warrants and warrants in registered direct offerings and private placement, net of issuance costs	$ 3	$ 1,833,924
Issuance of common stock, pre-funded warrants and warrants in registered direct offerings and private placement, net of issuance costs (in shares)	30,500
Exercise of pre-funded warrants into Common Stock																		$ 14	253		267
Exercise of pre-funded warrants into Common Stock (in shares)																		133,750
Issuance of common stock in connection with the exercise of warrants, net of offering costs										$ 29	$ 3,706,742	$ 3,706,771
Issuance of Common Stock in connection with the exercise of warrants, net of offering costs (in shares)										294,101
Deemed dividend of Series B preferred stock																			(49,292)		(49,292)
Conversion of Series B preferred shares into common stock (in shares)																	(24)	22
Common stock issued to consultants																		$ 2,500	76,000		76,000
Issuance of common stock from RSU vest (in shares)																		1,851
Deemed dividend related to exchange of Series B preferred stock			$ 1,833,927
Stock-based compensation																			263,330		263,330
Net loss																				(3,434,158)	(3,434,158)
Balance at the end (in shares) at Sep. 30, 2023																	522	673,174
Balance at the end at Sep. 30, 2023																		$ 67	183,506,470	(180,227,732)	3,278,805
Mezzanine Equity - Balance at the beginning (in shares) at Dec. 31, 2023																0
Mezzanine Equity - Balance at the beginning at Dec. 31, 2023																$ 0
Balance at the beginning (in shares) at Dec. 31, 2023																	515	1,560,998
Balance at the beginning at Dec. 31, 2023																	$ 0	$ 156	187,931,445	(184,328,672)	3,602,929
Issuance of common stock, pre-funded warrants and warrants in registered direct offerings and private placement, net of issuance costs																		$ 44	4,495,482		4,495,526
Issuance of common stock, pre-funded warrants and warrants in registered direct offerings and private placement, net of issuance costs (in shares)																		448,100
Issuance of stock upon acquisition of IMGX																$ 57,790,474		$ 4	2,300,496		2,300,500
Issuance of stock upon acquisition of IMGX (in shares)																11,777		36,830
Issuance of stock to financial advisors																$ 3,890,626		$ 2	120,646		120,648
Issuance of stock to financial advisors (in shares)																596		18,475
Exercise of pre-funded warrants into Common Stock																		$ 45			45
Exercise of pre-funded warrants into Common Stock (in shares)																		443,525
Issuance of common stock in connection with the exercise of warrants, net of offering costs				$ 176	$ 1,730,189	$ 1,730,365
Issuance of Common Stock in connection with the exercise of warrants, net of offering costs (in shares)				1,762,674
Deemed dividend of Series B preferred stock																			(188,834)		(188,834)
Conversion of Series B preferred shares into common stock (in shares)																	(30)	27
Common stock issued to consultants																		$ 35	1,541,960		1,541,995
Common stock issued to consultants (in shares)																		350,000
Issuance of common stock from RSU vest																		$ 12	(12)
Issuance of common stock from RSU vest (in shares)																		121,335
Stock-based compensation																			586,896		586,896
Net loss																				(5,821,067)	(5,821,067)
Mezzanine Equity - Balance at the end (in shares) at Sep. 30, 2024																12,373
Mezzanine Equity - Balance at the end at Sep. 30, 2024																$ 61,681,100					61,681,100
Balance at the end (in shares) at Sep. 30, 2024																	485	4,741,964
Balance at the end at Sep. 30, 2024																		$ 474	198,518,268	(190,149,739)	8,369,003
Mezzanine Equity - Balance at the beginning (in shares) at Jun. 30, 2024																12,373
Mezzanine Equity - Balance at the beginning at Jun. 30, 2024																$ 61,681,100
Balance at the beginning (in shares) at Jun. 30, 2024																	485	2,941,108
Balance at the beginning at Jun. 30, 2024																		$ 294	196,689,069	(187,568,768)	9,120,595
Issuance of common stock in connection with the exercise of warrants, net of offering costs				$ 176	$ 1,730,189	$ 1,730,365
Issuance of Common Stock in connection with the exercise of warrants, net of offering costs (in shares)				1,762,674
Deemed dividend of Series B preferred stock																			(84,632)		(84,632)
Issuance of common stock from RSU vest																		$ 4	(4)
Issuance of common stock from RSU vest (in shares)																		38,182
Stock-based compensation																			183,646		183,646
Net loss																				(2,580,971)	(2,580,971)
Mezzanine Equity - Balance at the end (in shares) at Sep. 30, 2024																12,373
Mezzanine Equity - Balance at the end at Sep. 30, 2024																$ 61,681,100					61,681,100
Balance at the end (in shares) at Sep. 30, 2024																	485	4,741,964
Balance at the end at Sep. 30, 2024																		$ 474	$ 198,518,268	$ (190,149,739)	$ 8,369,003

Condensed Consolidated Statements of Mezzanine Equity and Changes in Stockholders' Equity (unaudited) (Parenthetical)			9 Months Ended
	Dec. 18, 2023	Jan. 18, 2023	Sep. 30, 2023
Condensed Consolidated Statements of Mezzanine Equity and Changes in Stockholders' Equity (unaudited)
Reverse stock split ratio	0.05	0.143	0.143

Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities:
Net loss	$ (5,821,067)	$ (11,694,043)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	48,946	21,955
Amortization of debt discount	5,848
Change in right-of-use assets	55,262	47,429
Stock-based compensation	586,896	914,350
Common stock granted to consultants	1,541,995	76,000
Common stock issued to financial advisors at acquisition	120,648
Series G convertible preferred stock issued to financial advisors at acquisition	3,890,626
Deferred taxes	(10,604,640)
Changes in assets and liabilities:
Other receivables		93,014
Prepaid expenses	939,005	1,272,558
Lease liabilities	(58,004)	(48,919)
Deposits	(117,000)	6,899
Accounts payable	900,546	(140,749)
Accrued expenses	(531,127)	514,364
Other liabilities	(4,239)	(1,332)
Net cash used in operating activities	(9,046,305)	(8,938,474)
Cash flows from investing activities:
Cash acquired in acquisition of IMGX	88,169
Net cash provided by investing activities	88,169
Cash flows from financing activities:
Proceeds from issuance of common stock, prefunded warrants and warrants, net	4,495,526	5,525,010
Proceeds from the issuance of common stock in connection with the exercise of warrants in the July 2024 Inducement Offering, net	1,730,365
Proceeds from exercise of warrants, net of issuance costs		5,946,383
Proceeds from exercise of pre-funded warrants	45
Repayments of note payable	(644,582)	(603,494)
Proceeds from note payable	31,798
Net cash provided by financing activities	5,613,152	10,867,899
Net (decrease) increase in cash, cash equivalents and restricted cash	(3,344,984)	1,929,425
Cash, cash equivalents and restricted cash, beginning balance	3,733,292	1,384,423
Cash, cash equivalents and restricted cash, ending balance	388,308	3,313,848
Supplemental disclosures of cash flow information:
Cash paid for interest	30,468	15,414
Non-cash investing and financing activities:
Fair value of common shares issued in the IMGX acquisition, net of cash	152,331
Fair value of the Series G preferred stock issued in the IMGX acquisition	57,790,474
Fair value of options assumed in the IMGX acquisition	1,271,000
Fair value of warrants assumed in the IMGX acquisition	789,000
Accrued dividends on preferred stock	$ (188,834)	$ (231,047)

The Company and Basis of Presentation

9 Months Ended

Sep. 30, 2024

The Company and Basis of Presentation

The Company and Basis of Presentation

Note 1 - The Company and Basis of Presentation

The Company

In May 2024, the Company changed its name from First Wave Biopharma, Inc. to Entero Therapeutics, Inc.

Risks and Uncertainties

Principles of Consolidation

Substantial Doubt about the Company’s Ability to Continue as a Going Concern

Significant Accounting Policies and Recent Accounting Pronouncements

9 Months Ended

Sep. 30, 2024

Significant Accounting Policies and Recent Accounting Pronouncements

Significant Accounting Policies and Recent Accounting Pronouncements

Note 2 - Significant Accounting Policies and Recent Accounting Pronouncements

Use of Estimates

Reverse Stock Split

All share and per share amounts have been retroactively restated to reflect the reverse stock splits referenced above.

Cash and Cash Equivalents and Restricted Cash

Concentrations of Credit Risk

Fair Value Measurements

As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:

Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;

Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use.

The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period.

Goodwill

Impairment of Long-Lived Assets

Income Taxes

Leases

Research and Development

Research and Development – Intellectual Property Acquired

For tax purposes, intangible assets related to IPR&D are considered indefinite-lived intangible assets.

Stock-Based Compensation

Assets Held for Sale and Discontinued Operations

Additional details surrounding the Company’s assets and liabilities held for sale and discontinued operations are included in Note 4.

Recent Accounting Pronouncements

Business Acquisition

9 Months Ended

Sep. 30, 2024

Business Acquisition

Business Acquisition

Note 3 – Business Acquisition

The Company incurred transaction costs of $5,456,038 which are included in the Company’s condensed consolidated statement of operations.


	Amount
Common stock issued to ImmunogenX stockholders	$	240,500
Replacement options		1,271,000
Replacement warrants		789,000
Preferred stock issued to ImmunogenX stockholders		57,790,474
Total consideration paid	$	60,090,974


Assets acquired:
Cash and cash equivalents	$	88,169
Prepaid expenses and other current assets		3,131,929
Property and equipment, net		18,963
Intangibles		63,370,000
Operating lease right-of-use assets		4,232
Total assets	$	66,613,293
Liabilities assumed:
Accounts payable		916,209
Accrued expenses and other current liabilities		2,131,439
Long term debt		6,397,889
Deferred tax liability		13,760,280
Total liabilities	$	23,205,817
Goodwill recorded:
Goodwill	$	16,683,498
Net assets acquired	$	60,090,974

All intangible assets acquired are subject to amortization and their associated estimated acquisition date fair values are as follows:


	Estimated	Acquisition Date
Intangible Asset	Useful Life	Fair Value
Patents	2 years	$	140,000
Trade names and trademarks	6 years		230,000
IPR&D – Latiglutenase	Indefinite		54,000,000
IPR&D - CypCel	Indefinite	$	9,000,000

The Merger is classified as held for sale as of September 30, 2024. Refer to Note 4 for further information.

Pro forma disclosure for the IMGX acquisition


	Three Months		Nine Months
	Ended September 30, 2024		Ended September 30, 2024
Operating expenses	$	1,892,607	$	14,417,763
Loss before income tax benefit		(1,895,252)		(14,424,947)
Loss from discontinued operations		(685,719)		(9,374,674)
Net loss applicable to common shareholders		(2,665,603)		(13,345,757)

Basic and diluted weighted average shares outstanding		4,552,019		3,005,055
Loss per share - basic and diluted	$	(0.59)	$	(4.44)

Discontinued Operations and Assets and Liabilities Held for Sale

9 Months Ended

Sep. 30, 2024

Discontinued Operations and Assets and Liabilities Held for Sale

Discontinued Operations and Assets and Liabilities Held for Sale

Notes 4 – Discontinued Operations and Assets and Liabilities Held for Sale

The following table summarizes the Company’s loss from discontinued operations for the three and nine months ended September 30, 2024 and 2023.


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Operating expenses:
Research and development expenses	$	301,661	$	—	$	1,225,533	$	—
General and administrative expenses		76,971		—		152,187		—
Total operating expenses		378,632		—		1,377,720		—
Interest expense		(305,614)		—		(670,296)		—
Other (expense) income		(1,473)		—		47,256		—
Loss from discontinued operations	$	(685,719)	$	—	$	(2,000,760)	$	—

The assets and liabilities associated with discontinued operations consist of the following as of September 30, 2024:


Assets held for sale:
Prepaid expenses and other current assets	$	3,131,929
Property and equipment, net		16,180
Goodwill and intangible assets		80,021,900
Total assets held for sale	$	83,170,009
Liabilities held for sale:
Accounts payable	$	156,086
Accrued expenses and other current liabilities		2,202,798
Debt		6,403,737
Deferred tax liability		3,155,640
Total liabilities held for sale	$	11,918,261

Total assets and liabilities classified as held for sale are presented as current assets and liabilities, respectively, as they are anticipated to be sold within 12 months.

Fair Value Disclosures

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures

Fair Value Disclosures

Note 5 - Fair Value Disclosures

The fair value of the Company’s financial instruments are as follows:


			Fair Value Measured at Reporting Date
			Using
	Carrying
	Amount		Level 1		Level 2		Level 3		Fair Value
September 30, 2024 (unaudited):
Money market funds	$	12,573	$	12,573	$	—	$	—	$	12,573

December 31, 2023:
Money market funds	$	12,131	$	12,131	$	—	$	—	$	12,131
Note payable		612,784		—		612,784	$	—		612,784

At September 30, 2024 and December 31, 2023, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with U.S. GAAP.

Property, Equipment and Leasehold Improvements

9 Months Ended

Sep. 30, 2024

Property, Equipment and Leasehold Improvements

Property, Equipment and Leasehold Improvements

Note 6 – Property, Equipment and Leasehold Improvements

Property, equipment and leasehold improvements consisted of the following:


	September 30,
	2024		December 31,
	(unaudited)		2023
Computer equipment and software	$	11,540	$	11,540
Office equipment		48,278		48,278
Leasehold improvements		28,000		28,000
Total property, equipment and leasehold improvements		87,818		87,818
Less accumulated depreciation		(87,818)		(73,253)
Property, equipment and leasehold improvements, net	$	—	$	14,565

Goodwill

9 Months Ended

Sep. 30, 2024

Goodwill

Goodwill

Note 7 –Goodwill

Goodwill is as follows:


	Goodwill
Balance on January 1, 2023	$	1,684,182
Balance on December 31, 2023		1,684,182
Goodwill associated with IMGX acquisition		16,683,498
Goodwill reclassified as held for sale	$	(16,683,498)
Balance on September 30, 2024 (unaudited)	$	1,684,182

Intangible Assets and In-Process R&D

9 Months Ended

Sep. 30, 2024

Intangible Assets and In-Process R&D

Intangible Assets and In-Process R&D

Note 8 – Intangible Assets and In-Process R&D


	Estimated	September 30,
	Useful Life	2024
Patents	2 years	$	140,000
Trademarks and trade names	6 years		230,000
Less: accumulated amortization			(31,598)
Intangible assets, net			338,402
In-process R&D			63,000,000
Intangible assets and in-process R&D reclassified as held for sale			(63,338,402)
Total intangible assets and in-process R&D, net		$	—

Accrued Expenses

9 Months Ended

Sep. 30, 2024

Accrued Expenses

Accrued Expenses

Note 9 - Accrued Expenses

Accrued expenses consisted of the following:


	September 30,
	2024		December 31,
	(unaudited)		2023
Professional fees		215,531		253,577
Consulting fees		—		75,972
Payroll and benefits		3,662		495,741
Total accrued expenses	$	219,193	$	825,290

Accrued expenses in the amount of $2.2 million and $0 were reclassified as assets held for sale as of September 30, 2024 and 2023, respectively.

Capital Stock

9 Months Ended

Sep. 30, 2024

Capital Stock

Capital Stock

Note 10 – Capital Stock

Common Stock and Preferred Stock

The Company had 4,741,964 and 1,560,998 shares of its Common Stock issued and outstanding on September 30, 2024 and December 31, 2023, respectively.

The Company had approximately 484.52 and 514.96 shares of Series B preferred stock issued and outstanding on September 30, 2024 and December 31, 2023, respectively.

The Company had 0 shares of Series C, Series D, Series E and Series F preferred stock issued and outstanding on September 30, 2024 and December 31, 2023.

Most Favored Nations Exchange Right and Waiver Agreements

Mezzanine Equity

Series G Preferred Stock

The Company had 12,373.226 and 0 shares of Series G stock issued and outstanding on September 30, 2024 and December 31, 2023, respectively.

Liquidation Preference. The Series G Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company.

Redemption. The shares of Series G Preferred Stock shall not be redeemable at the option of the Company or the holder thereof.

At The Market Agreement with H.C. Wainwright

July 2024 Inducement Offering

May 2024 Registered Direct Offering

The Company received gross proceeds of approximately $1.1 million less placement agent’s fees and other offering expenses of approximately $0.2 million.

March 2024 Registered Direct Offering

September 2023 Inducement Offering

July 2023 Offering

June 2023 Inducement Offering

March 2023 Private Placement

Common Stock Issuances

Issuances for the Three Months Ended September 30, 2024

During the three months ended September 30, 2024, the Company issued an aggregate of 38,182 shares of Common Stock upon the vesting of RSUs (See Note 12).

Issuances for the Nine Months Ended September 30, 2024

During the nine months ended September 30, 2024, the Company issued an aggregate of 36,830 shares of Common Stock with a value of $2.3 million in connection with the IMGX acquisition.

During the nine months ended September 30, 2024, the Company issued an aggregate of 121,335 shares of Common Stock upon the vesting of RSUs (See Note 12).

Issuances for the Three Months Ended September 30, 2023

During the three months ended September 30, 2023, the Company issued an aggregate of 133,750 shares of Common Stock upon the conversion of pre-funded warrants issued at a par value of $0.0001.

During the three months ended September 30, 2023, the Company issued an aggregate of 1,851 shares of Common Stock upon the vesting RSUs (See Note 12).

Issuances for the Nine Months Ended September 30, 2023

During the nine months ended September 30, 2023, the Company issued an aggregate of 199,974 shares of Common Stock upon the exercise of pre-funded warrants issued at a par value of $0.0001.

During the nine months ended September 30, 2023, the Company issued an aggregate of 3,854 shares of Common Stock upon the vesting of RSUs.

During the nine months ended September 30, 2023, the Company cancelled an aggregate of 148 shares of Common Stock in connection with the 1-for-7 reverse stock split on January 18, 2023.

Warrants

9 Months Ended

Sep. 30, 2024

Warrants

Warrants

Note 11 – Warrants

Warrant activity for the nine months ended September 30, 2024 and 2023 was as follows:


		Weighted		Weighted
		Average		Average
	Number of	Exercise Price		Remaining
	Warrants	Per Share		Term in Years
Outstanding and exercisable on January 1, 2024	1,779,780	$	19.29	4.99
Issued	5,226,498		1.87	4.85
Assumed from IMGX	127,680		3.48	8.47
Expired	(3)		52,500.00	—
Exercised	(2,206,199)		3.99	8.58
Warrants outstanding and exercisable on September 30, 2024	4,927,756	$	7.21	4.96

Warrants outstanding and exercisable on January 1, 2023	108,797	$	383.20	5.50
Issued	1,369,940		14.60	4.59
Expired	(4)		15,475.80	—
Exercised	(580,293)		19.20	4.72
Warrants outstanding and exercisable on September 30, 2023	898,440	$	47.60	4.89

As of September 30, 2024, the outstanding warrants expire from 2024 through 2033.

Equity Incentive Plan

9 Months Ended

Sep. 30, 2024

Equity Incentive Plan

Equity Incentive Plan

Note 12 – Equity Incentive Plan

As of January 1, 2024, the number of shares of Common Stock available for issuance under the 2020 Plan automatically increased to 334,078 under the 2020 Plan’s evergreen provision.

As of September 30, 2024, there were an aggregate of 350,000 total shares available (but un-issuable) under the IMGX 2021 Plan, of which 200,652 are issued and outstanding.

As of September 30, 2024, 334,078 total shares were authorized under the 2020 Plan, of which 208,763 were issued and outstanding and 125,315 shares were available for potential issuances.

During the nine months ended September 30, 2024 and 2023, stock option activity under the 2014 Plan, 2020 Plan, and IMGX 2021 Plan was as follows:


		Average		Remaining
	Number	Exercise		Contract	Intrinsic
	of Shares	Price		Life (Years)	Value
Outstanding at January 1, 2024	426	$	6,103.81	8.53	$	—
Assumed from ImmunogenX	200,652		0.81	7.05		—
Expired	(15)		18,720.80	—		—
Outstanding at September 30, 2024	201,063	$	12.01	7.05	$	—
Exercisable at September 30, 2024	201,052	$	11.74	7.05	$	—

Outstanding at January 1, 2023	176	$	15,956.72	8.22	$	—
Granted	250		74.60	9.40		—
Outstanding at September 30, 2023	426	$	7,946.60	8.68	$	—
Exercisable at September 30, 2023	331	$	9,284.40	8.62	$	—


	2024		2023
Contractual term (in years)	7.6		6.5
Expected Volatility	110.35	%	98.80	%
Risk-free interest rate	4.20	%	4.08	%
Expected Dividend yield	0	%	0	%

Restricted Stock and Restricted Stock Units

During the nine months ended September 30, 2024 and 2023, RSU activity under the 2020 Plan was as follows:


		Weighted-Average		Weighted-Average
	Number	Grant Date		Remaining Recognition
	of Shares	Fair Value		Period (Years)
Non-vested Outstanding at January 1, 2024	52,271	$	4.31	9.96
Awarded	150,421		3.57	—
Vested	(133,401)		3.91	—
Cancelled	(52,225)		3.32	—
Non-vested Outstanding at September 30, 2024	17,066	$	3.86	0.85

Non-vested Outstanding at January 1, 2023	—		—	—
Awarded	8,012	$	124.00	—
Vested	(5,680)		124.00	—
Canceled	(508)		124.00	—
Non-vested Outstanding at September 30, 2023	1,824	$	124.00	0.25

The total stock-based compensation expense for employees and non-employees is included in the accompanying condensed consolidated statements of operations and as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development	$	9,550	$	34,847	$	60,045	$	111,092
General and administrative		174,096		228,483		526,851		803,258
Total stock-based compensation expense	$	183,646	$	263,330	$	586,896	$	914,350

Agreements

9 Months Ended

Sep. 30, 2024

Agreements

Agreements

Note 13 – Agreements

License Agreement with Sanofi

Leases

9 Months Ended

Sep. 30, 2024

Leases

Leases

Note 14 – Leases

The Company leases its offices under operating leases which are subject to various rent provisions and escalation clauses.

The Company’s leases expire at various dates through 2026. The escalation clauses are indeterminable and considered not material and have been excluded from minimum future annual rental payments.

The weighted-average remaining lease term and weighted-average discount rate under operating leases as of September 30, 2024 are:


	September 30,
	2024
Lease term and discount rate
Weighted-average remaining lease term (years)	1.9
Weighted-average discount rate	7.00	%

Maturities of operating lease liabilities as of September 30, 2024, were as follows:


2024 (remainder of year)	$	21,815
2025		88,788
2026		60,593
Total lease payments		171,196
Less imputed interest		(11,529)
Present value of lease liabilities	$	159,667

Debt

9 Months Ended

Sep. 30, 2024

Debt

Debt

Note 15 – Debt

Debt consists of the following:


			Related				Directors
			party				and Officer’s
	Revolving		promissory				Liability
	line of credit		notes		EIDL loan		Insurance		Total
Principal balance as of January 1, 2024	$	—	$	—	$	—	$	612,784	$	612,784
Additions		5,359,860		1,000,000		500,000		31,798		6,891,658
Payments		—		—		—		(644,582)		(644,582)
Debt discount		—		—		(456,123)		—		(456,123)
Reclassification to liabilities held for sale		(5,359,860)		(1,000,000)		(43,877)		—		(6,403,737)
Total debt as of September 30, 2024	$	—	$	—	$	—	$	—	$	—

Revolving line of credit

Promissory notes

EIDL loan

Directors and Officer’s Liability Insurance

Net Loss per Common Share

9 Months Ended

Sep. 30, 2024

Net Loss per Common Share

Net Loss per Common Share

Note 16 – Net Loss per Common Share

All shares of Common Stock that may potentially be issued in the future are as follows:


	September 30, 2024	September 30, 2023
	(unaudited)	(unaudited)
Series G convertible preferred stock	12,373,226	—
Common stock warrants	4,927,756	898,440
Stock options	201,063	426
RSUs not yet issued	17,066	1,824
Series B convertible preferred stock (1)	135	154
Restricted stock not yet issued	4	8
Total shares of common stock issuable	17,519,250	900,852

(1)	Series B convertible preferred stock is assumed to be converted at the rate of $32,340 per common share, which is the conversion price as of September 30, 2024.

Employee Benefit Plans

9 Months Ended

Sep. 30, 2024

Employee Benefit Plans

Employee Benefit Plans

Note 17 - Employee Benefit Plans

401(k) Plan

Income Taxes

9 Months Ended

Sep. 30, 2024

Income Taxes

Income Taxes

Note 18 - Income Taxes

Subsequent Events

9 Months Ended

Sep. 30, 2024

Subsequent Events

Subsequent Events

Note 19 - Subsequent Events

Binding Term Sheet

Lease Termination

In November 2024, the Company terminated its lease in Newport Beach, California.

Share Issuances

In October 2024, the Company issued an aggregate of 12,066 shares of Common Stock upon the vesting of RSUs.

Pay vs Performance Disclosure - USD ($)	3 Months Ended		9 Months Ended
Pay vs Performance Disclosure - USD ($)	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (2,580,971)	$ (3,434,158)	$ (5,821,067)	$ (11,694,043)

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	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

Significant Accounting Policies and Recent Accounting Pronouncements (Policies)	9 Months Ended
	Sep. 30, 2024
Significant Accounting Policies and Recent Accounting Pronouncements
Use of Estimates	Use of Estimates The accompanying unaudited condensed consolidated financial statements are prepared in conformity with GAAP and include certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements (including goodwill), and the reported amounts of revenue and expense during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates.
Reverse Stock Split	Reverse Stock Split On December 18, 2023, the Company effected a reverse stock split, whereby every twenty shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. On January 18, 2023, the Company effected a reverse stock split, whereby every seven shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. All share and per share amounts have been retroactively restated to reflect the reverse stock splits referenced above.
Cash and Cash Equivalents and Restricted Cash	Cash and Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with maturities of three months or less from the date of purchase to be cash equivalents. All cash and cash equivalent balances were highly liquid at September 30, 2024 and December 31, 2023. As of September 30, 2024 and December 31, 2023, the Company has classified approximately $0.02 million as restricted cash.
Concentrations of Credit Risk	Concentrations of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash. The Company primarily maintains its cash balances with financial institutions in federally insured accounts in the U.S. The Company may from time to time have cash in banks in excess of FDIC insurance limits. At September 30, 2024 the Company had approximately $0.4 million in one account in the U.S. which was in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company mitigates its risk by maintaining the majority of its cash and equivalents with high quality financial institutions.
Fair Value Measurements	Fair Value Measurements The Company follows Accounting Standards Codification (“ASC”) Topic 820-10, Fair Value Measurements and Disclosures (“ASC 820”), which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument. The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period.
Goodwill	Goodwill Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company has not recognized any impairment charges through September 30, 2024 related to goodwill.
Impairment of Long-Lived Assets	Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment (“ASC 360”). Potential impairment is assessed when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. The recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends and product development cycles. If impairments are identified, assets are written down to their estimated fair value. The Company has not recognized any impairment charges through September 30, 2024.
Income Taxes	Income Taxes Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. The Company determines its deferred tax assets and liabilities based on differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. At September 30, 2024 and 2023, the Company does not have any significant uncertain tax positions.
Leases	Leases Leases are recorded on the balance sheet as right of use assets and lease obligations. Lease liabilities are recognized based on the present value of the future minimum lease payments over the least term at the commencement date. Leases with a term of 12 months or less at inception are expensed monthly over the lease term. The lease term is determined by assuming the exercise of renewal options that are reasonably certain. The implicit interest rate or the incremental borrowing rate is used in determining the present value of future payments.
Research and Development	Research and Development Research and development costs are charged to operations when incurred and are included in operating expenses, except for goodwill related to patents. Research and development costs consist principally of compensation of employees and consultants that perform the Company’s research activities, payments to third parties for preclinical and non-clinical activities, expenses with clinical research organizations (“CROs”), investigative sites, consultants and contractors that conduct or provide other services relating to clinical trials, costs to acquire drug product, drug supply and clinical trial materials from contract development and manufacturing organization (“CDMOs”) and third-party contractors relating to chemistry, manufacturing and controls (“CMC”) efforts, the fees paid for and to maintain the Company’s licenses and research and development costs related to Adrulipase, Capeserod and Niclosamide. Depending upon the timing of payments to the service providers, the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s estimates of the work performed under service agreements, milestones achieved and experience with similar contracts. The Company monitors each of these factors and adjusts estimates accordingly. Research and Development – Intellectual Property Acquired The Company records intellectual property acquired in business acquisitions that has not reached technological feasibility and which has no alternative future use, as In-Process R&D (“IPR&D”) at the acquisition date. On March 13, 2024, the Company entered into an acquisition agreement with IMGX which included the intellectual property and patents for Latiglutenase and CypCel, which was accounted for as a business acquisition (see Note 3 and Note 4). Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-off, and the Company will record a noncash impairment loss on its Consolidated Statements of Operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. The impairment test for indefinite-lived intangible assets is a one-step test that compares the fair value of the intangible asset to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. The Company has not recognized any impairment charges through September 30, 2024 related to IPR&D. For tax purposes, intangible assets related to IPR&D are considered indefinite-lived intangible assets.
Stock-Based Compensation	Stock-Based Compensation The Company’s board of directors (the “Board”) and stockholders have adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “2014 Plan”) which took effect on May 12, 2014, and the 2020 Omnibus Equity Incentive Plan, which took effect on September 11, 2020 (the “2020 Plan”). From the effective date of the 2020 Plan, no new awards have been or will be made under the 2014 Plan. On March 13, 2024, in connection with the IMGX acquisition, the Company assumed IMGX’s 2021 Stock Option Plan (the “IMGX Plan”), including all IMGX stock options immediately outstanding prior to the IMGX acquisition, with each becoming an option to purchase Common Stock, subject to adjustment. The IMGX Plan was adopted and approved by the board of directors and stockholders of IMGX in 2021. Following the assumption of the IMGX Plan by the Company, no new awards have been or will be made under the IMGX Plan. The Company accounts for its stock-based compensation awards to employees, consultants, and Board members in accordance with ASC Topic 718, Compensation-Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, consultants, and Board members, including grants of employee stock options, to be recognized in the statements of operations by measuring the fair value of the award on the date of grant and recognizing this fair value as stock-based compensation using a straight-line method over the requisite service period, generally the vesting period. For awards with performance conditions that affect their vesting, such as the occurrence of certain transactions or the achievement of certain operating or financial milestones, recognition of fair value of the award occurs when vesting becomes probable. The Company estimates the grant date fair value of stock option awards using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock.
Assets Held for Sale and Discontinued Operations	Assets Held for Sale and Discontinued Operations Assets and liabilities are classified as held for sale when all of the following criteria for a plan of sale have been met: (1) management, having the authority to approve the action, commits to a plan to sell the assets; (2) the assets are available for immediate sale, in their present condition, subject only to terms that are usual and customary for sales of such assets; (3) an active program to locate a buyer and other actions required to complete the plan to sell the assets have been initiated; (4) the sale of the assets is probable and is expected to be completed within one year; (5) the assets are being actively marketed for a price that is reasonable in relation to their current fair value; and (6) actions required to complete the plan indicate that it is unlikely that significant changes to the plan will be made or the plan will be withdrawn. When all of these criteria have been met, the assets and liabilities are classified as held for sale in the condensed consolidated balance sheet. A newly acquired business in a business combination that has met the held for sale criteria should be measured at fair value less costs to sell. This is because the business has been recently acquired and its carrying value has been adjusted to its fair value. Depreciation and amortization of assets cease upon designation as held for sale. Discontinued operations comprise activities that were disposed of, discontinued or held for sale at the end of the period, represent a separate major line of business that can be clearly distinguished for operational and financial reporting purposes, and represent a strategic business shift having a major effect on the Company’s operations and financial results according to ASC Topic 205, Presentation of Financial Statements. Additional details surrounding the Company’s assets and liabilities held for sale and discontinued operations are included in Note 4.
Recent Accounting Pronouncements	Recent Accounting Pronouncements The Company has evaluated recently issued accounting pronouncements and has concluded that the impact of recently issued standards that are not yet effective, will not have a material impact on the Company’s financial position or results of operations upon adoption.

Business Acquisition (Tables)

9 Months Ended

Sep. 30, 2024

Business Acquisition

Schedule of preliminary fair value of the consideration


	Amount
Common stock issued to ImmunogenX stockholders	$	240,500
Replacement options		1,271,000
Replacement warrants		789,000
Preferred stock issued to ImmunogenX stockholders		57,790,474
Total consideration paid	$	60,090,974

Schedule of preliminary purchase price allocation


Assets acquired:
Cash and cash equivalents	$	88,169
Prepaid expenses and other current assets		3,131,929
Property and equipment, net		18,963
Intangibles		63,370,000
Operating lease right-of-use assets		4,232
Total assets	$	66,613,293
Liabilities assumed:
Accounts payable		916,209
Accrued expenses and other current liabilities		2,131,439
Long term debt		6,397,889
Deferred tax liability		13,760,280
Total liabilities	$	23,205,817
Goodwill recorded:
Goodwill	$	16,683,498
Net assets acquired	$	60,090,974

Schedule of intangible assets acquired


	Estimated	Acquisition Date
Intangible Asset	Useful Life	Fair Value
Patents	2 years	$	140,000
Trade names and trademarks	6 years		230,000
IPR&D – Latiglutenase	Indefinite		54,000,000
IPR&D - CypCel	Indefinite	$	9,000,000

Schedule of pro forma results


	Three Months		Nine Months
	Ended September 30, 2024		Ended September 30, 2024
Operating expenses	$	1,892,607	$	14,417,763
Loss before income tax benefit		(1,895,252)		(14,424,947)
Loss from discontinued operations		(685,719)		(9,374,674)
Net loss applicable to common shareholders		(2,665,603)		(13,345,757)

Basic and diluted weighted average shares outstanding		4,552,019		3,005,055
Loss per share - basic and diluted	$	(0.59)	$	(4.44)

Discontinued Operations and Assets and Liabilities Held for Sale (Tables)

9 Months Ended

Sep. 30, 2024

Discontinued Operations and Assets and Liabilities Held for Sale

Schedule of loss from discontinued operations and assets and liabilities associated with discontinued operations


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Operating expenses:
Research and development expenses	$	301,661	$	—	$	1,225,533	$	—
General and administrative expenses		76,971		—		152,187		—
Total operating expenses		378,632		—		1,377,720		—
Interest expense		(305,614)		—		(670,296)		—
Other (expense) income		(1,473)		—		47,256		—
Loss from discontinued operations	$	(685,719)	$	—	$	(2,000,760)	$	—

The assets and liabilities associated with discontinued operations consist of the following as of September 30, 2024:


Assets held for sale:
Prepaid expenses and other current assets	$	3,131,929
Property and equipment, net		16,180
Goodwill and intangible assets		80,021,900
Total assets held for sale	$	83,170,009
Liabilities held for sale:
Accounts payable	$	156,086
Accrued expenses and other current liabilities		2,202,798
Debt		6,403,737
Deferred tax liability		3,155,640
Total liabilities held for sale	$	11,918,261

Fair Value Disclosures (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures

Schedule of fair value of the Company's financial instruments


			Fair Value Measured at Reporting Date
			Using
	Carrying
	Amount		Level 1		Level 2		Level 3		Fair Value
September 30, 2024 (unaudited):
Money market funds	$	12,573	$	12,573	$	—	$	—	$	12,573

December 31, 2023:
Money market funds	$	12,131	$	12,131	$	—	$	—	$	12,131
Note payable		612,784		—		612,784	$	—		612,784

Property, Equipment and Leasehold Improvements (Tables)

9 Months Ended

Sep. 30, 2024

Property, Equipment and Leasehold Improvements

Schedule of property, equipment and leasehold improvements


	September 30,
	2024		December 31,
	(unaudited)		2023
Computer equipment and software	$	11,540	$	11,540
Office equipment		48,278		48,278
Leasehold improvements		28,000		28,000
Total property, equipment and leasehold improvements		87,818		87,818
Less accumulated depreciation		(87,818)		(73,253)
Property, equipment and leasehold improvements, net	$	—	$	14,565

Goodwill (Tables)

9 Months Ended

Sep. 30, 2024

Goodwill

Schedule of goodwill


	Goodwill
Balance on January 1, 2023	$	1,684,182
Balance on December 31, 2023		1,684,182
Goodwill associated with IMGX acquisition		16,683,498
Goodwill reclassified as held for sale	$	(16,683,498)
Balance on September 30, 2024 (unaudited)	$	1,684,182

Intangible Assets and In-Process R&D (Tables)

9 Months Ended

Sep. 30, 2024

Intangible Assets and In-Process R&D

Summary of patents, tradenames and trademarks, intangible assets and in-process R&D from IMGX


	Estimated	September 30,
	Useful Life	2024
Patents	2 years	$	140,000
Trademarks and trade names	6 years		230,000
Less: accumulated amortization			(31,598)
Intangible assets, net			338,402
In-process R&D			63,000,000
Intangible assets and in-process R&D reclassified as held for sale			(63,338,402)
Total intangible assets and in-process R&D, net		$	—

Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2024

Accrued Expenses

Schedule of accrued expenses


	September 30,
	2024		December 31,
	(unaudited)		2023
Professional fees		215,531		253,577
Consulting fees		—		75,972
Payroll and benefits		3,662		495,741
Total accrued expenses	$	219,193	$	825,290

Warrants (Tables)

9 Months Ended

Sep. 30, 2024

Warrants

Schedule of warrant activity


		Weighted		Weighted
		Average		Average
	Number of	Exercise Price		Remaining
	Warrants	Per Share		Term in Years
Outstanding and exercisable on January 1, 2024	1,779,780	$	19.29	4.99
Issued	5,226,498		1.87	4.85
Assumed from IMGX	127,680		3.48	8.47
Expired	(3)		52,500.00	—
Exercised	(2,206,199)		3.99	8.58
Warrants outstanding and exercisable on September 30, 2024	4,927,756	$	7.21	4.96

Warrants outstanding and exercisable on January 1, 2023	108,797	$	383.20	5.50
Issued	1,369,940		14.60	4.59
Expired	(4)		15,475.80	—
Exercised	(580,293)		19.20	4.72
Warrants outstanding and exercisable on September 30, 2023	898,440	$	47.60	4.89

Equity Incentive Plan (Tables)

9 Months Ended

Sep. 30, 2024

Equity Incentive Plan

Schedule of stock option activity


		Average		Remaining
	Number	Exercise		Contract	Intrinsic
	of Shares	Price		Life (Years)	Value
Outstanding at January 1, 2024	426	$	6,103.81	8.53	$	—
Assumed from ImmunogenX	200,652		0.81	7.05		—
Expired	(15)		18,720.80	—		—
Outstanding at September 30, 2024	201,063	$	12.01	7.05	$	—
Exercisable at September 30, 2024	201,052	$	11.74	7.05	$	—

Outstanding at January 1, 2023	176	$	15,956.72	8.22	$	—
Granted	250		74.60	9.40		—
Outstanding at September 30, 2023	426	$	7,946.60	8.68	$	—
Exercisable at September 30, 2023	331	$	9,284.40	8.62	$	—

Schedule of option pricing model with the following weighted-average assumptions


	2024		2023
Contractual term (in years)	7.6		6.5
Expected Volatility	110.35	%	98.80	%
Risk-free interest rate	4.20	%	4.08	%
Expected Dividend yield	0	%	0	%

Schedule of RSU activity under the 2020 Plan


		Weighted-Average		Weighted-Average
	Number	Grant Date		Remaining Recognition
	of Shares	Fair Value		Period (Years)
Non-vested Outstanding at January 1, 2024	52,271	$	4.31	9.96
Awarded	150,421		3.57	—
Vested	(133,401)		3.91	—
Cancelled	(52,225)		3.32	—
Non-vested Outstanding at September 30, 2024	17,066	$	3.86	0.85

Non-vested Outstanding at January 1, 2023	—		—	—
Awarded	8,012	$	124.00	—
Vested	(5,680)		124.00	—
Canceled	(508)		124.00	—
Non-vested Outstanding at September 30, 2023	1,824	$	124.00	0.25

Schedule of stock-based compensation expense


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development	$	9,550	$	34,847	$	60,045	$	111,092
General and administrative		174,096		228,483		526,851		803,258
Total stock-based compensation expense	$	183,646	$	263,330	$	586,896	$	914,350

Leases (Tables)

9 Months Ended

Sep. 30, 2024

Leases

Schedule of weighted-average remaining lease term and weighted-average discount rate under operating leases


	September 30,
	2024
Lease term and discount rate
Weighted-average remaining lease term (years)	1.9
Weighted-average discount rate	7.00	%

Schedule of maturities of operating lease liabilities

Maturities of operating lease liabilities as of September 30, 2024, were as follows:


2024 (remainder of year)	$	21,815
2025		88,788
2026		60,593
Total lease payments		171,196
Less imputed interest		(11,529)
Present value of lease liabilities	$	159,667

Debt (Tables)

9 Months Ended

Sep. 30, 2024

Debt

Schedule of debt


			Related				Directors
			party				and Officer’s
	Revolving		promissory				Liability
	line of credit		notes		EIDL loan		Insurance		Total
Principal balance as of January 1, 2024	$	—	$	—	$	—	$	612,784	$	612,784
Additions		5,359,860		1,000,000		500,000		31,798		6,891,658
Payments		—		—		—		(644,582)		(644,582)
Debt discount		—		—		(456,123)		—		(456,123)
Reclassification to liabilities held for sale		(5,359,860)		(1,000,000)		(43,877)		—		(6,403,737)
Total debt as of September 30, 2024	$	—	$	—	$	—	$	—	$	—

Net Loss per Common Share (Tables)

9 Months Ended

Sep. 30, 2024

Net Loss per Common Share

Schedule of Common Stock that may potentially be issued in the future


	September 30, 2024	September 30, 2023
	(unaudited)	(unaudited)
Series G convertible preferred stock	12,373,226	—
Common stock warrants	4,927,756	898,440
Stock options	201,063	426
RSUs not yet issued	17,066	1,824
Series B convertible preferred stock (1)	135	154
Restricted stock not yet issued	4	8
Total shares of common stock issuable	17,519,250	900,852

(1)	Series B convertible preferred stock is assumed to be converted at the rate of $32,340 per common share, which is the conversion price as of September 30, 2024.

The Company and Basis of Presentation (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
The Company and Basis of Presentation
Cash and cash equivalents	$ 366,788	$ 3,711,770
Accumulated deficit	$ (190,149,739)	$ (184,328,672)

Significant Accounting Policies and Recent Accounting Pronouncements (Details) $ in Thousands			9 Months Ended
	Dec. 18, 2023	Jan. 18, 2023	Sep. 30, 2023	Sep. 30, 2024 USD ($)	Dec. 31, 2023 USD ($)
Significant Accounting Policies and Recent Accounting Pronouncements
Reverse stock split ratio	0.05	0.143	0.143
Restricted cash				$ 20	$ 20
Cash in US banks in excess of FDIC insurance limits				$ 400

Business Acquisition (Details)		7 Months Ended
Business Acquisition (Details)	Mar. 13, 2024 USD ($) $ / shares shares	Sep. 30, 2024 USD ($) shares	Dec. 31, 2023 shares
Business Acquisition
Common stock. Shares outstanding		4,741,964	1,560,998
Common stock, shares issued (in shares)		4,741,964	1,560,998
IMGX
Business Acquisition
Share issuable per each share of preferred stock converted	1,000
Transaction costs \| $	$ 5,456,038
Amount of advisory fees included in transaction cost \| $	4,000,000.0
Preliminary fair value of consideration amount \| $	$ 60,100,000
Net losses of acquiree from the date of acquisition \| $		$ 2,000,000.0
IMGX \| Common Stock
Business Acquisition
Number of shares issued	36,830
Common stock. Shares outstanding	2,303,135
Common stock, shares issued (in shares)	2,303,135
IMGX \| Common Stock \| Tungsten Partners LLC
Business Acquisition
Issuance of stock to financial advisors (in shares)	18,475
IMGX \| Common Stock \| Assumed Options
Business Acquisition
Number of shares issuable upon exercise of options or warrants	200,652
Exercise price per share \| $ / shares	$ 0.81
IMGX \| Common Stock \| Assumed Warrants
Business Acquisition
Number of shares issuable upon exercise of options or warrants	127,680
IMGX \| Common Stock \| Assumed Warrants \| Maximum
Business Acquisition
Exercise price per share \| $ / shares	$ 3.92
IMGX \| Common Stock \| Assumed Warrants \| Minimum
Business Acquisition
Exercise price per share \| $ / shares	$ 3.03
IMGX \| Series G convertible preferred stock
Business Acquisition
Number of shares issued	11,777.418
IMGX \| Series G convertible preferred stock \| Tungsten Partners LLC
Business Acquisition
Issuance of stock to financial advisors (in shares)	595.808

Business Acquisition - Consideration (Details) - IMGX	Mar. 13, 2024 USD ($)
Business Acquisition
Total consideration paid	$ 60,090,974
Replacement options
Business Acquisition
Replacement options/warrants	1,271,000
Replacement warrants
Business Acquisition
Replacement options/warrants	789,000
Common Stock
Business Acquisition
Stock issued to ImmunogenX stockholders	240,500
Series G convertible preferred stock
Business Acquisition
Stock issued to ImmunogenX stockholders	$ 57,790,474

Business Acquisition - Assets acquired and the liabilities assumed (Details) - USD ($)	Sep. 30, 2024	Mar. 13, 2024	Dec. 31, 2023	Dec. 31, 2022
Liabilities assumed:
Goodwill	$ 1,684,182		$ 1,684,182	$ 1,684,182
IMGX
Assets acquired:
Cash and cash equivalents		$ 88,169
Prepaid expenses and other current assets		3,131,929
Property and equipment, net		18,963
Intangibles		63,370,000
Operating lease right-of-use assets		4,232
Total assets		66,613,293
Liabilities assumed:
Accounts payable		916,209
Accrued expenses and other current liabilities		2,131,439
Long term debt		6,397,889
Deferred tax liability		13,760,280
Total liabilities		23,205,817
Goodwill		16,683,498
Net assets acquired		$ 60,090,974

Business Acquisition - Amortization and associated estimated acquisition date fair values (Details) - IMGX	Mar. 13, 2024 USD ($)
Business Acquisition
Acquisition Date Fair Value	$ 63,370,000
IPR&D - Latiglutenase
Business Acquisition
Acquisition Date Fair Value	54,000,000
IPR&D - CypCel
Business Acquisition
Acquisition Date Fair Value	$ 9,000,000
Patents
Business Acquisition
Estimated Useful Life	2 years
Acquisition Date Fair Value	$ 140,000
Trade names and trademarks
Business Acquisition
Estimated Useful Life	6 years
Acquisition Date Fair Value	$ 230,000

Business Acquisition - Pro forma results (Details) - IMGX - USD ($)	3 Months Ended	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2024
Business Acquisition
Operating expenses	$ 1,892,607	$ 14,417,763
Loss before income tax benefit	(1,895,252)	(14,424,947)
Loss from discontinued operations	(685,719)	(9,374,674)
Net loss applicable to common shareholders	$ (2,665,603)	$ (13,345,757)
Basic weighted average shares outstanding	4,552,019	3,005,055
Diluted weighted average shares outstanding	4,552,019	3,005,055
Loss per share - basic	$ (0.59)	$ (4.44)
Loss per share - diluted	$ (0.59)	$ (4.44)

Discontinued Operations and Assets and Liabilities Held for Sale (Details) - USD ($)	3 Months Ended	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2024	Sep. 30, 2023
Loss from discontinued operations
Loss from discontinued operations	$ (685,719)	$ (2,000,760)
Assets held for sale:
Property and equipment, net	16,000	16,000	$ 0
Total assets held for sale	83,170,009	83,170,009
Liabilities held for sale:
Total liabilities held for sale	11,918,261	11,918,261
IMGX \| Disposal Group, Held-for-Sale
Loss from discontinued operations
Research and development expenses	301,661	1,225,533
General and administrative expenses	76,971	152,187
Total operating expenses	378,632	1,377,720
Interest expense	(305,614)	(670,296)
Other income		47,256
Other (expense)	(1,473)
Loss from discontinued operations	(685,719)	(2,000,760)
Assets held for sale:
Prepaid expenses and other current assets	3,131,929	3,131,929
Property and equipment, net	16,180	16,180
Goodwill and intangible assets	80,021,900	80,021,900
Total assets held for sale	83,170,009	83,170,009
Liabilities held for sale:
Accounts payable	156,086	156,086
Accrued expenses and other current liabilities	2,202,798	2,202,798
Debt	6,403,737	6,403,737
Deferred tax liability	3,155,640	3,155,640
Total liabilities held for sale	$ 11,918,261	$ 11,918,261

Fair Value Disclosures (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Fair Value Disclosures
Money market funds	$ 366,788	$ 3,711,770
Note payable		612,784
Carrying Amount
Fair Value Disclosures
Note payable		612,784
Level 2
Fair Value Disclosures
Note payable		612,784
Money market funds
Fair Value Disclosures
Money market funds	12,573	12,131
Money market funds \| Carrying Amount
Fair Value Disclosures
Money market funds	12,573	12,131
Money market funds \| Level 1
Fair Value Disclosures
Money market funds	$ 12,573	$ 12,131

Property, Equipment and Leasehold Improvements (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Property, Equipment and Leasehold Improvements
Total property, equipment and leasehold improvements	$ 87,818		$ 87,818		$ 87,818
Less accumulated depreciation	(87,818)		(87,818)		(73,253)
Property, equipment and leasehold improvements, net					14,565
Depreciation	1,000	$ 7,000	15,000	$ 22,000
Fixed assets held for sale	16,000	$ 0	16,000	$ 0
Computer equipment and software
Property, Equipment and Leasehold Improvements
Total property, equipment and leasehold improvements	11,540		11,540		11,540
Office equipment
Property, Equipment and Leasehold Improvements
Total property, equipment and leasehold improvements	48,278		48,278		48,278
Leasehold improvements
Property, Equipment and Leasehold Improvements
Total property, equipment and leasehold improvements	$ 28,000		$ 28,000		$ 28,000

Goodwill (Details)	9 Months Ended
Goodwill (Details)	Sep. 30, 2024 USD ($)
Goodwill
Beginning balance	$ 1,684,182
Goodwill associated with IMGX acquisition	16,683,498
Goodwill reclassified as held for sale	(16,683,498)
Ending balance	$ 1,684,182

Intangible Assets and In-Process R&D (Details)	Sep. 30, 2024 USD ($)
Intangible Assets and In-Process R&D
Less: accumulated amortization	$ (31,598)
Intangible assets, net	338,402
Intangible assets and in-process R&D reclassified as held for sale	(63,338,402)
IPR&D
Intangible Assets and In-Process R&D
In-process R&D	63,000,000
Patents
Intangible Assets and In-Process R&D
Finite-lived intangible assets	$ 140,000
Finite-lived intangible assets, useful life (year)	2 years
Trademarks and trade names
Intangible Assets and In-Process R&D
Finite-lived intangible assets	$ 230,000
Finite-lived intangible assets, useful life (year)	6 years

Accrued Expenses (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023	Sep. 30, 2023
Accrued Expenses
Professional fees	$ 215,531	$ 253,577
Consulting fees		75,972
Payroll and benefits	3,662	495,741
Total accrued expenses	219,193	$ 825,290
Accrued expenses	$ 2,200,000		$ 0

Capital Stock (Details)													3 Months Ended		9 Months Ended
Capital Stock (Details)	Jul. 10, 2024 USD ($) $ / shares shares	May 14, 2024 USD ($) $ / shares shares	Mar. 06, 2024 USD ($) $ / shares shares	Dec. 18, 2023	Sep. 14, 2023 USD ($) $ / shares shares	Jul. 21, 2023 USD ($) $ / shares shares	Jun. 13, 2023 USD ($) $ / shares shares	Mar. 15, 2023 USD ($) $ / shares shares	Jan. 18, 2023	May 24, 2022 USD ($)	May 12, 2022	May 26, 2021	Sep. 30, 2024 USD ($) $ / shares shares	Sep. 30, 2023 USD ($) $ / shares shares	Sep. 30, 2024 USD ($) $ / shares shares	Sep. 30, 2023 USD ($) $ / shares shares	Jun. 30, 2024 shares	Mar. 13, 2024 shares	Dec. 31, 2023 $ / shares shares
Capital Stock
Common stock, shares authorized (in shares)													100,000,000		100,000,000				100,000,000
Common stock, par or stated value per share (in dollars per share) \| $ / shares													$ 0.0001		$ 0.0001				$ 0.0001
Preferred stock, shares authorized (in shares)													10,000,000		10,000,000
Preferred stock, par or stated value per share (in dollars per share) \| $ / shares													$ 0.0001		$ 0.0001
Common stock, shares, issued, total (in shares)													4,741,964		4,741,964				1,560,998
Common stock, shares outstanding (in shares)													4,741,964		4,741,964				1,560,998
Convertible preferred stock, shares issued upon conversion (in shares)																		1,000
Stock issued during period, value, acquisitions \| $															$ 2,300,500
Issuance of stock to financial advisors \| $															$ 120,648
Stock cancelled during period, shares, acquisitions (in shares)																148
Reverse stock split ratio				0.05					0.143							0.143
Proceeds from warrants exercise \| $																$ 5,946,383
September 2023 Inducement Warrants
Capital Stock
Warrants to purchase of stock					294,101
Warrant exercise price \| $ / shares					$ 8.60
Inducement warrants
Capital Stock
Warrants to purchase of stock													3,525,348		3,525,348
Consultants
Capital Stock
Stock issued during period, shares, settlement (in shares)														2,500	350,000	2,500
Stock issued during period, value, settlement \| $														$ 76,000	$ 1,541,995	$ 76,000
Restricted Stock Units
Capital Stock
Issuance of common stock from RSU vest (in shares)													38,182
Conversion of stock, shares issued (in shares)														1,851	121,335	3,854
September 2023 Inducement Offering
Capital Stock
Proceeds from issuance of shares \| $					$ 4,000,000.0
Payment made for services rendered \| $					$ 200,000
September 2023 Inducement Offering \| September 2023 Inducement Warrants
Capital Stock
Warrants to purchase of stock					588,204
Warrant exercise price \| $ / shares					$ 2.50
At The Market Offering Agreement \| Wainwright
Capital Stock
Stock sales agreement, commission on shares sold, percentage												3.00%
Stock sales agreement of shares authorized amount \| $										$ 8,000,000.0
March 2024 Registered Direct Offering
Capital Stock
Stock issued during period, shares, new issues (in shares)			173,100
Number of common stock shares called by each warrant (in shares)			1
Warrants and rights outstanding, term (year)			5 years
Gross proceeds \| $			$ 4,000,000.0
Other offering expenses \| $			$ 400,000
Shares of common stock \| $ / shares			$ 7.61
March 2024 Registered Direct Offering \| March 2024 warrants
Capital Stock
Warrants to purchase of stock													525,625		525,625
Stock issued during period, shares, new issues (in shares)			525,625
Warrant exercise price \| $ / shares			$ 7.48
March 2024 Registered Direct Offering \| March 2024 pre-funded warrants
Capital Stock
Warrants to purchase of stock													352,525		352,525
Stock issued during period, shares, new issues (in shares)			352,525
Warrant exercise price \| $ / shares			$ 0.0001
Private placement
Capital Stock
Number of common stock shares called by each warrant (in shares)								1
Warrants and rights outstanding, term (year)								5 years
Gross proceeds \| $								$ 4,000,000.0
Other offering expenses \| $								$ 300,000
Shares of common stock \| $ / shares								$ 78.20
June 2023 inducement offering
Capital Stock
Warrants to purchase of stock							172,433
Warrant exercise price \| $ / shares							$ 2.50
Proceeds from issuance of shares \| $							$ 2,400,000
Payment made for services rendered \| $							$ 200,000
June 2023 inducement offering \| Existing warrants
Capital Stock
Warrants to purchase of stock							86,216							172,433		172,433
Warrant exercise price \| $ / shares							$ 23.00
May 2024 registered direct offering
Capital Stock
Stock issued during period, shares, new issues (in shares)		275,000
Number of common stock shares called by each warrant (in shares)		1
Warrants and rights outstanding, term (year)		6 years
Gross proceeds \| $		$ 1,100,000
Other offering expenses \| $		$ 200,000
Shares of common stock \| $ / shares		$ 2.95
May 2024 registered direct offering \| May 2024 pre-funded warrants
Capital Stock
Warrants to purchase of stock													91,000		91,000
Stock issued during period, shares, new issues (in shares)		91,000
Warrant exercise price \| $ / shares		$ 0.0001
May 2024 registered direct offering \| May 2024 warrants
Capital Stock
Warrants to purchase of stock													732,000		732,000
Stock issued during period, shares, new issues (in shares)		732,000
Warrant exercise price \| $ / shares		$ 2.70
July 2023 Offering
Capital Stock
Stock issued during period, shares, new issues (in shares)						30,500
Number of common stock shares called by each warrant (in shares)						1
Shares of common stock \| $ / shares						$ 12.80
July 2023 Pre-Funded Warrants
Capital Stock
Stock issued during period, shares, new issues (in shares)						133,750
Number of common stock shares called by each warrant (in shares)						133,750
Warrant exercise price \| $ / shares						$ 0.002
July 2023 Warrants
Capital Stock
Stock issued during period, shares, new issues (in shares)						328,500
Warrants and rights outstanding, term (year)						5 years
Warrant exercise price \| $ / shares						$ 12.80
July 2024 Inducement Offering
Capital Stock
Proceeds from warrants exercise \| $	$ 1,900,000
Amount paid for services \| $	$ 100,000
July 2024 Inducement Offering \| Existing warrants
Capital Stock
Warrants to purchase of stock	1,762,674
Warrant exercise price \| $ / shares	$ 1.09
July 2024 Inducement Offering \| Inducement warrants
Capital Stock
Warrants to purchase of stock	3,525,348
Public Offering
Capital Stock
Gross proceeds \| $						$ 2,100,000
Other offering expenses \| $						$ 300,000
Common stock warrants \| September 2023 Inducement Offering
Capital Stock
Proceeds from Issuance of Common Stock \| $														$ 3,700,000		$ 3,700,000
Common stock issued upon exercise of warrants (in shares)														294,101
Class of warrant or right, exercised during period (in shares)																294,101
Common stock warrants \| June 2023 inducement offering
Capital Stock
Proceeds from Issuance of Common Stock \| $																$ 2,200,000
Class of warrant or right, exercised during period (in shares)														294,101		86,216
Pre-funded warrants
Capital Stock
Exercise of pre-funded warrants into Common Stock														133,750	443,525	199,974
Par value per warrant \| $ / shares														$ 0.0001	$ 0.0001	$ 0.0001
Series B convertible preferred stock
Capital Stock
Preferred stock, shares authorized (in shares)													5,194.81		5,194.81				5,194.81
Preferred stock, par or stated value per share (in dollars per share) \| $ / shares													$ 0.0001		$ 0.0001				$ 0.0001
Preferred stock, shares issued (in shares)													484.52		484.52				514.96
Preferred stock, shares outstanding (in shares)													484.52		484.52				514.96
Exchange Amount \| $													$ 7,700.00		$ 7,700.00
Series B convertible preferred stock \| Waiver
Capital Stock
Percentage of outstanding shares											81.30%
Series B convertible preferred stock \| Series B Preferred Stock Converted into Common Stock
Capital Stock
Conversion of stock, shares converted (in shares)														24.22	30	28.45
Common stock issued upon conversion of preferred stock \| $														$ 186,500	$ 234,376	$ 219,000
Conversion of stock, amount converted, accrued dividends \| $														$ 43,300	70,429	$ 49,500
Series B Preferred Stock convertible into Series C Preferred Stock
Capital Stock
Exchange Amount \| $													14,400,000		$ 14,400,000
Conversion of stock, shares converted (in shares)															1,839.76
Conversion of Series B preferred shares into common stock (in shares)															395
Series B Preferred Stock convertible into Series C Preferred Stock \| Investor warrants
Capital Stock
Conversion of Series B preferred shares into common stock (in shares)															395
Series B Preferred Stock convertible into common stock with no warrants
Capital Stock
Exchange Amount \| $													1,500,000		$ 1,500,000
Conversion of stock, shares converted (in shares)															160.62
Conversion of Series B preferred shares into common stock (in shares)															128
Series B Preferred Stock Convertible Into Common Stock With Series C Warrants
Capital Stock
Exchange Amount \| $													$ 265,000		$ 265,000
Conversion of stock, shares converted (in shares)															30.91
Conversion of Series B preferred shares into common stock (in shares)															44
Series B Preferred Stock Convertible Into Common Stock With Series C Warrants \| March 2024 Warrants
Capital Stock
Warrants to purchase of stock													44		44
Series C Preferred Stock
Capital Stock
Preferred stock, shares authorized (in shares)													75,000		75,000				75,000
Preferred stock, par or stated value per share (in dollars per share) \| $ / shares													$ 0.0001		$ 0.0001				$ 0.0001
Preferred stock, shares issued (in shares)													0		0		0		0
Preferred stock, shares outstanding (in shares)													0		0		0		0
Series C Preferred Stock \| Private placement
Capital Stock
Number of common shares issuable upon conversion								44,751
Series D Preferred Stock
Capital Stock
Preferred stock, shares authorized (in shares)													150		150				150
Preferred stock, par or stated value per share (in dollars per share) \| $ / shares													$ 0.0001		$ 0.0001				$ 0.0001
Preferred stock, shares issued (in shares)													0		0				0
Preferred stock, shares outstanding (in shares)													0		0				0
Series D Preferred Stock \| Private placement
Capital Stock
Stock issued during period, shares, new issues (in shares)								6,400
Preferred stock, convertible, conversion price (in dollars per share) \| $ / shares								$ 0.002
Series G convertible preferred stock
Capital Stock
Temporary Equity, Shares Issued													12,373.226		12,373.226				0
Temporary Equity, Shares Outstanding													12,373.226		12,373.226				0
Series G convertible preferred stock \| IMGX
Capital Stock
Temporary Equity, Shares Issued																		12,373.226
Series G Redeemable Preferred Stock
Capital Stock
Temporary Equity, Shares Issued													12,373.226		12,373.226				0
Temporary Equity, Shares Outstanding													12,373.226		12,373.226				0
Series E Preferred Stock
Capital Stock
Preferred stock, shares authorized (in shares)													150		150				150
Preferred stock, par or stated value per share (in dollars per share) \| $ / shares													$ 0.0001		$ 0.0001				$ 0.0001
Preferred stock, shares issued (in shares)													0		0				0
Preferred stock, shares outstanding (in shares)													0		0				0
Series E Preferred Stock \| Private placement
Capital Stock
Number of common shares issuable upon conversion								102,302
Warrant exercise price \| $ / shares								$ 73.20
Series F Preferred Stock
Capital Stock
Preferred stock, shares authorized (in shares)													7,000		7,000				7,000
Preferred stock, par or stated value per share (in dollars per share) \| $ / shares													$ 0.0001		$ 0.0001				$ 0.0001
Preferred stock, shares issued (in shares)													0		0				0
Preferred stock, shares outstanding (in shares)													0		0				0
Common Stock
Capital Stock
Proceeds from Issuance of Common Stock \| $															$ 4,500,000
Conversion of stock, shares issued (in shares)														22	27	26
Common Stock \| IMGX
Capital Stock
Stock Issued During Period, Shares, Acquisitions (in shares)															36,830
Stock issued during period, value, acquisitions \| $															$ 2,300,000
Issuance of stock to financial advisors (in shares)															18,475
Issuance of stock to financial advisors \| $															$ 100,000
Common Stock \| September 2023 Inducement Offering
Capital Stock
Common stock issued upon exercise of warrants (in shares)																294,101
Common Stock \| March 2024 Registered Direct Offering
Capital Stock
Stock issued during period, shares, new issues (in shares)															173,100
Common Stock \| July 2024 Inducement offering
Capital Stock
Proceeds from Issuance of Common Stock \| $															$ 1,700,000
Common Stock \| March 2023 offering
Capital Stock
Stock issued during period, shares, new issues (in shares)																6,400
Proceeds from Issuance of Common Stock \| $																$ 3,700,000
Common Stock \| June 2023 inducement offering
Capital Stock
Common stock issued upon exercise of warrants (in shares)														30,500		86,216
Common Stock \| May 2024 registered direct offering
Capital Stock
Stock issued during period, shares, new issues (in shares)															275,000
Common Stock \| July 2023 Offering
Capital Stock
Stock issued during period, shares, new issues (in shares)																30,500
Common Stock \| July 2024 Inducement Offering
Capital Stock
Stock issued during period, shares, new issues (in shares)													1,762,674		1,762,674
Proceeds from Issuance of Common Stock \| $													$ 1,700,000
Common Stock \| Common stock warrants \| July 2023 Offering
Capital Stock
Proceeds from Issuance of Common Stock \| $														$ 1,800,000		$ 1,800,000
Maximum \| Series G convertible preferred stock
Capital Stock
Preferred Stock, Beneficial Ownership Held, Percentage																		19.90%
Minimum \| Series G convertible preferred stock
Capital Stock
Threshold limits of ownership percentage																		4.9

Warrants (Details) - $ / shares	9 Months Ended		12 Months Ended
Warrants (Details) - $ / shares	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Dec. 31, 2022	May 14, 2024	Mar. 06, 2024	Jun. 13, 2023
Number of Warrants
Outstanding and exercisable, beginning (in shares)	1,779,780	108,797	108,797
Issued (in shares)	5,226,498	1,369,940
Assumed from IMGX (in shares)	127,680
Expired during the period (in shares)	(3)	(4)
Exercised (in shares)	(2,206,199)	(580,293)
Warrants outstanding and exercisable, ending (in shares)	4,927,756	898,440	1,779,780	108,797
Weighted Average Exercise Price Per Share
Outstanding and exercisable, beginning (in dollars per share)	$ 19.29	$ 383.20	$ 383.20
Issued (in dollars per share)	1.87	14.60
Assumed from IMGX (in dollars per share)	3.48
Expired during the period (in dollars per share)	52,500.00	15,475.80
Exercised (in dollars per share)	3.99	19.20
Warrants outstanding and exercisable, ending (in dollars per share)	$ 7.21	$ 47.60	$ 19.29	$ 383.20
Weighted Average Remaining Term in Years
Outstanding and exercisable (in years)	4 years 11 months 15 days	4 years 10 months 20 days	4 years 11 months 26 days	5 years 6 months
Issued (in years)	4 years 10 months 6 days	4 years 7 months 2 days
Assumed from IMGX (in years)	8 years 5 months 19 days
Expired (in years)	0 years	0 years
Exercised (in years)	8 years 6 months 29 days	4 years 8 months 19 days
September 2023 Inducement Warrants
Number of Warrants
Assumed from IMGX (in shares)		588,204
July 2023 Inducement Offering [member]
Weighted Average Remaining Term in Years
Warrants to purchase of stock		462,250
June 2023 inducement offering
Weighted Average Remaining Term in Years
Warrants to purchase of stock							172,433
Exercise price per share							$ 2.50
March 2024 pre-funded warrants \| March 2024 registered direct offering
Weighted Average Remaining Term in Years
Warrants to purchase of stock	352,525
Exercise price per share						$ 0.0001
March 2024 warrants \| March 2024 registered direct offering
Weighted Average Remaining Term in Years
Warrants to purchase of stock	525,625
Exercise price per share						$ 7.48
May 2024 pre-funded warrants \| May 2024 registered direct offering
Weighted Average Remaining Term in Years
Warrants to purchase of stock	91,000
Exercise price per share					$ 0.0001
May 2024 warrants \| May 2024 registered direct offering
Weighted Average Remaining Term in Years
Warrants to purchase of stock	732,000
Exercise price per share					$ 2.70
March 2023 pre-funded warrants \| March 2023 registered direct offering
Weighted Average Remaining Term in Years
Warrants to purchase of stock		44,751
March 2023 warrants \| March 2023 registered direct offering \| Common Stock
Weighted Average Remaining Term in Years
Warrants to purchase of stock		102,302
Existing warrants \| June 2023 inducement offering
Weighted Average Remaining Term in Years
Warrants to purchase of stock		172,433					86,216
Exercise price per share							$ 23.00
Inducement warrants
Weighted Average Remaining Term in Years
Warrants to purchase of stock	3,525,348
Pre-funded warrants
Number of Warrants
Exercise of pre-funded warrants into Common Stock (in shares)	443,525	199,974
Common stock warrants \| July 2024 Inducement offering
Number of Warrants
Exercise of pre-funded warrants into Common Stock (in shares)	1,762,674
Common stock warrants \| July 2023 Inducement Offering [member]
Number of Warrants
Exercise of pre-funded warrants into Common Stock (in shares)		380,319

Equity Incentive Plan (Details) - USD ($)		1 Months Ended		3 Months Ended	9 Months Ended
Equity Incentive Plan (Details) - USD ($)	Sep. 11, 2020	Oct. 31, 2024	Oct. 31, 2023	Sep. 30, 2024	Sep. 30, 2024	Sep. 30, 2023	Mar. 13, 2024	Jan. 01, 2024	Dec. 31, 2023
Equity Incentive Plan
Unrecognized stock-based compensation expense				$ 78,000	$ 78,000	$ 600,000
Stock-based compensation					586,896	914,350
Remaining term
Equity Incentive Plan
Unrecognized stock-based compensation expense				61,000	$ 61,000	$ 400,000
Average remaining vesting term of the stock options (in years)					10 months 6 days	7 months 28 days
Clinical, corporate milestones
Equity Incentive Plan
Unrecognized stock-based compensation expense				$ 17,000	$ 17,000	$ 200,000
Employee Stock Option
Equity Incentive Plan
Granted (in shares)					357
Restricted Stock Units \| Subsequent events
Equity Incentive Plan
Issuance of common stock for vesting of RSUs		12,066
Stock option
Equity Incentive Plan
Weighted average fair value of warrants granted (in dollars per share)					$ 6.32	$ 61.00
2020 Equity Incentive Plan
Equity Incentive Plan
Shares available under equity incentive plan (in shares)	238			334,078	334,078			334,078
Percentage of common stock reserved for issuance equity incentive plan	10.00%
Options to purchase shares of common stock (in shares)				208,763	208,763
Shares reserved subject to issuance (in shares)				125,315	125,315
Options cancelled						250
Vesting period						36 months
2020 Equity Incentive Plan \| Restricted Stock Units
Equity Incentive Plan
Vested in period (in shares)					133,401	5,680
Issuance of common stock for vesting of RSUs			1,826
Number of awards outstanding				17,066	17,066	1,824			52,271
Awarded (in shares)					150,421	8,012
Vesting period					1 year
Equity Incentive Plan 2014 \| RSUs not yet issued
Equity Incentive Plan
Number of awards outstanding				1	1	1
Aggregate unrecognized restricted Common Stock expense				$ 157,500	$ 157,500	$ 157,500
Omnibus Equity Incentive Plan
Equity Incentive Plan
Shares available under equity incentive plan (in shares)				73	73
Options to purchase shares of common stock (in shares)				27	27
Omnibus Equity Incentive Plan \| RSUs not yet issued
Equity Incentive Plan
Shares reserved subject to issuance (in shares)				9	9
IMGX 2021 plan
Equity Incentive Plan
Shares available under equity incentive plan (in shares)				350,000	350,000
Options to purchase shares of common stock (in shares)				200,652	200,652
Number of share options assumed in business combination issued					200,652
IMGX Plan
Equity Incentive Plan
Stock-based compensation				$ 6,000	$ 19,000
IMGX Plan \| ImmunogenX
Equity Incentive Plan
Options to purchase shares of common stock (in shares)							200,652

Equity Incentive Plan - Stock option activity (Details) - Stock option - $ / shares	9 Months Ended		12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Dec. 31, 2022
Numbers of Shares
Granted (in shares)	357
Amended and Restated Omnibus Equity Incentive Plan 2014, Omnibus Equity Incentive Plan 2020 and IMGX 2021 Plan
Numbers of Shares
Outstanding at beginning (in shares)	426	176	176
Assumed from ImmunogenX (in shares)	200,652
Granted (in shares)		250
Expired (in shares)	(15)
Outstanding at ending (in shares)	201,063	426	426	176
Exercisable (in shares)	201,052	331
Average Exercise Price
Outstanding at beginning (in dollars per share)	$ 6,103.81	$ 15,956.72	$ 15,956.72
Assumed from ImmunogenX (in dollars per share)	0.81
Granted (in dollars per share)		74.60
Expired (in dollars per share)	18,720.80
Outstanding at ending (in dollars per share)	12.01	7,946.60	$ 6,103.81	$ 15,956.72
Exercisable (in dollars per share)	$ 11.74	$ 9,284.40
Remaining Contract Life (Years)
Stock option outstanding, remaining contractual life (Years)	7 years 18 days	8 years 8 months 4 days	8 years 6 months 10 days	8 years 2 months 19 days
Assumed from ImmunogenX (in years)	7 years 18 days
Granted (in years)		9 years 4 months 24 days
Exercisable (in years)	7 years 18 days	8 years 7 months 13 days

Equity Incentive Plan - Weighted-average assumptions (Details) - Stock option	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Equity Incentive Plan
Contractual term (in years)	7 years 7 months 6 days	6 years 6 months
Expected Volatility	110.35%	98.80%
Risk-free interest rate	4.20%	4.08%
Expected Dividend yield	0.00%	0.00%

Equity Incentive Plan - RSU activity under the 2020 Plan (Details) - 2020 Equity Incentive Plan - Restricted Stock Units - $ / shares	9 Months Ended		12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Number of Shares
Outstanding at beginning (in shares)	52,271
Awarded (in shares)	150,421	8,012
Vested (in shares)	(133,401)	(5,680)
Canceled (shares)	(52,225)	(508)
Outstanding at ending (in shares)	17,066	1,824	52,271
Weighted-Average Grant Date Fair Value
Outstanding at beginning (in dollars per share)	$ 4.31
Awarded (in dollars per share)	3.57	$ 124.00
Vested (in dollars per share)	3.91	124.00
Canceled (in dollars per share)	3.32	124.00
Outstanding at ending (in dollars per share)	$ 3.86	$ 124.00	$ 4.31
Weighted-Average Remaining Recognition Period (Years)	10 months 6 days	3 months	9 years 11 months 15 days

Equity Incentive Plan - Total stock-based compensation expense (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Equity Incentive Plan
Total stock-based compensation expense	$ 183,646	$ 263,330	$ 586,896	$ 914,350
Research and development
Equity Incentive Plan
Total stock-based compensation expense	9,550	34,847	60,045	111,092
General and administrative
Equity Incentive Plan
Total stock-based compensation expense	$ 174,096	$ 228,483	$ 526,851	$ 803,258

Agreements (Details) - USD ($)		1 Months Ended	3 Months Ended		9 Months Ended		12 Months Ended
Agreements (Details) - USD ($)	Sep. 13, 2023	Oct. 31, 2023	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Agreements
Research and development expenses			$ 206,999	$ 1,011,055	$ 882,522	$ 3,725,833
License agreement
Agreements
Upfront payment made to the third party		$ 500,000
License agreement \| Sanofi
Agreements
Research and development expenses							$ 500,000
Termination of contract, cure period					60 days
Termination of contract, cure period for payment breach					10 days
Number of days prior written notice to be issued					60 days
License agreement \| Sanofi \| Development and regulatory milestone
Agreements
Amount eligible to receive by third party	$ 46,000,000.0
License agreement \| Sanofi \| Commercial milestone
Agreements
Amount eligible to receive by third party	$ 235,000,000.0

Leases (Details)	3 Months Ended		9 Months Ended
Leases (Details)	Sep. 30, 2024 USD ($) ft² property	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($) ft² property	Sep. 30, 2023 USD ($)
Leases
Number of real property operating leases \| property	2		2
Operating lease, expense \| $	$ 55,000	$ 42,000	$ 136,000	$ 114,000
Boca Raton, Florida
Leases
Area of real estate property (Square Foot) \| ft²	3,472		3,472

Leases - Weighted-average remaining lease term and discount rate (Details)	Sep. 30, 2024
Leases
Weighted-average remaining lease term (years)	1 year 10 months 24 days
Weighted-average discount rate	7.00%

Leases - Maturities of operating lease liabilities (Details)	Sep. 30, 2024 USD ($)
Leases
2024 (remainder of year)	$ 21,815
2025	88,788
2026	60,593
Total lease payments	171,196
Less imputed interest	(11,529)
Present value of lease liabilities	$ 159,667

Debt (Details) - USD ($)	9 Months Ended
Debt (Details) - USD ($)	Sep. 30, 2024	Jun. 30, 2024	Mar. 13, 2024	Dec. 31, 2023	Nov. 30, 2023
Debt
Debt instrument, face amount				$ 612,784
Additions	$ 6,891,658
Payments	(644,582)
Debt discount	(456,123)
Reclassification to liabilities held for sale	(6,403,737)
Revolving line of credit
Debt
Additions	5,359,860
Reclassification to liabilities held for sale	(5,359,860)
Related party promissory notes
Debt
Debt instrument, face amount	500,000
Additions	1,000,000
Reclassification to liabilities held for sale	(1,000,000)
EIDL loan
Debt
Debt instrument, face amount	500,000
Additions	500,000
Debt discount	(456,123)		$ (462,000)
Reclassification to liabilities held for sale	(43,877)
Directors and Officer's Liability Insurance
Debt
Debt instrument, face amount		$ 32,000		612,784	$ 700,000
Additions	31,798
Payments	(644,582)
Total debt as of September 30, 2024	$ 0			$ 600,000

Debt - Additional information (Details)			1 Months Ended		9 Months Ended
Debt - Additional information (Details)	Mar. 13, 2024 USD ($)	Nov. 30, 2023 USD ($)	Mar. 31, 2024 item	Oct. 31, 2022 USD ($)	Sep. 30, 2024 USD ($)	Jun. 30, 2024 USD ($)	Dec. 31, 2023 USD ($)	Sep. 30, 2023 USD ($)
Debt
Amount of debt							$ 612,784
Debt discount					$ 456,123
Revolving line of credit
Debt
Maximum amount of borrowings				$ 6,000,000.0				$ 7,500,000
Spread on interest rate (in percent)	6.00%			4.50%
Investment, Variable Interest Rate, Type [Extensible Enumeration]	us-gaap:PrimeRateMember			us-gaap:PrimeRateMember
Related party promissory notes
Debt
Spread on interest rate (in percent)					4.50%
Investment, Variable Interest Rate, Type [Extensible Enumeration]					us-gaap:PrimeRateMember
Number of notes assumed \| item			2
Amount of debt					$ 500,000
EIDL loan
Debt
Amount of debt					$ 500,000
Interest rate (in percent)					3.75%
Debt instrument, fair value	$ 38,000
Debt discount	$ 462,000				$ 456,123
Directors and Officer's Liability Insurance
Debt
Amount outstanding					0		600,000
Amount of debt		$ 700,000				$ 32,000	$ 612,784
Interest rate (in percent)		7.90%
Term of debt		9 months
Monthly payments, including principal and interest					$ 100,000

Net Loss per Common Share - (Details) - shares	9 Months Ended
Net Loss per Common Share - (Details) - shares	Sep. 30, 2024	Sep. 30, 2023
Net Loss per Common Share
Shares of common stock issuable	17,519,250	900,852
Stock option
Net Loss per Common Share
Shares of common stock issuable	201,063
Common stock warrants
Net Loss per Common Share
Shares of common stock issuable	4,927,756

Net Loss per Common Share - Common Stock that may potentially be issued (Details) - $ / shares	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Net Loss per Common Share
Total shares of common stock issuable	17,519,250	900,852
Series G convertible preferred stock
Net Loss per Common Share
Total shares of common stock issuable	12,373,226
Common stock warrants
Net Loss per Common Share
Total shares of common stock issuable	4,927,756	898,440
Stock options
Net Loss per Common Share
Total shares of common stock issuable	201,063	426
RSUs not yet issued
Net Loss per Common Share
Total shares of common stock issuable	17,066	1,824
Series B convertible preferred stock
Net Loss per Common Share
Total shares of common stock issuable	135	154
Preferred stock, convertible, conversion price (in dollars per share)	$ 32,340
Restricted stock not yet issued
Net Loss per Common Share
Total shares of common stock issuable	4	8

Employee Benefit Plans (Details) - USD ($)	3 Months Ended		9 Months Ended
Employee Benefit Plans (Details) - USD ($)	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Employee Benefit Plans
Defined contribution plan, employers matching contribution, annual vesting percentage			6.00%
Defined benefit plan, plan assets, contributions by employer	$ 17,000	$ 21,000	$ 84,000	$ 68,000
Minimum
Employee Benefit Plans
Defined contribution plan, maximum annual contributions per employee, percent			1.00%
Maximum
Employee Benefit Plans
Defined contribution plan, maximum annual contributions per employee, percent			100.00%

Income Taxes (Details) - USD ($)	9 Months Ended
Income Taxes (Details) - USD ($)	Sep. 30, 2024	Sep. 30, 2023
Income Taxes
Deferred tax assets	$ 0	$ 0
Effective income tax	73.00%	0.00%
Income tax benefit	$ (10,600,000)

Subsequent Event (Details) - Subsequent events - USD ($) $ in Millions		1 Months Ended
	Nov. 08, 2024	Oct. 31, 2024
Journey Therapeutics, Inc.
Subsequent Events
Equity interest	100.00%
Proceeds from issuance of shares	$ 5.0
Percentage of return on equity interest	99.00%
Restricted Stock Units
Subsequent Events
Issuance of common stock for vesting of RSUs		12,066