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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended June 30, 2023
☐ |
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from to
COMMISSION
FILE NUMBER 001-39555
GREENWICH
LIFESCIENCES, INC.
(Exact
Name of registrant as specified in its charter)
Delaware |
|
20-5473709 |
(State
or other jurisdiction |
|
(I.R.S.
Employer |
of
incorporation or organization) |
|
Identification
No.) |
|
|
|
3992
Bluebonnet Dr., Building 14, Stafford, Texas |
|
77477 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(832)
819-3232 |
(Registrant’s
telephone number, including area code) |
Title
of each class: |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered: |
Common
Stock |
|
GLSI |
|
Nasdaq
Capital Market |
Indicate
by check mark whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act 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 and posted on its corporate Web site, if any, every Interactive Data
File required to be submitted and posted 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 and post such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,
or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐ |
|
Accelerated
filer ☐ |
|
Non-accelerated
filer ☒ |
|
Smaller
reporting company ☒ |
|
Emerging
growth company ☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 15, 2023, the issuer had 12,848,165 shares of Common Stock issued and outstanding.
GREENWICH
LIFESCIENCES, INC.
Table
of Contents
PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
GREENWICH
LIFESCIENCES, INC.
CONSOLIDATED
BALANCE SHEETS
AS
OF JUNE 30, 2023 AND DECEMBER 31, 2022 (UNAUDITED)
| |
June
30,
2023 | | |
December
31,
2022 | |
Assets | |
| | |
| |
Current assets | |
| | | |
| | |
Cash | |
$ | 10,944,242 | | |
$ | 13,468,026 | |
Non-current assets | |
| | | |
| | |
Acquired patents, net | |
| 7,197 | | |
| 9,003 | |
Total
assets | |
$ | 10,951,439 | | |
$ | 13,477,029 | |
| |
| | | |
| | |
Liabilities and stockholders’ equity | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable & accrued interest | |
$ | 300,463 | | |
$ | 220,845 | |
Unreimbursed expenses | |
| 1,083 | | |
| 42,060 | |
Total
current liabilities | |
| 301,546 | | |
| 262,905 | |
Total
liabilities | |
| 301,546 | | |
| 262,905 | |
| |
| | | |
| | |
Stockholders’ equity | |
| | | |
| | |
Common stock, $0.001 par value; 100,000,000 shares authorized; 12,848,165
shares issued and outstanding as of June 30, 2023 and December 31, 2022 | |
| 12,848 | | |
| 12,848 | |
Additional paid-in capital | |
| 55,863,086 | | |
| 54,674,042 | |
Accumulated deficit | |
| (45,226,041 | ) | |
| (41,472,766 | ) |
Total
stockholders’ equity | |
| 10,649,893 | | |
| 13,214,124 | |
Total
liabilities and stockholders’ equity | |
$ | 10,951,439 | | |
$ | 13,477,029 | |
See
accompanying notes to unaudited financial statements.
GREENWICH
LIFESCIENCES, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 AND 2022 (UNAUDITED)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three
Months Ended June 30, | | |
Six
Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenue | |
$ |
— | | |
$ |
— | | |
$ |
— | | |
$ |
— | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 1,379,567 | | |
| 633,250 | | |
| 3,207,474 | | |
| 2,294,071 | |
General and administrative | |
| 368,259 | | |
| 140,057 | | |
| 781,434 | | |
| 468,439 | |
Total
operating expenses | |
| 1,747,826 | | |
| 773,307 | | |
| 3,988,908 | | |
| 2,762,510 | |
Loss from operations | |
| (1,747,826 | ) | |
| (773,307 | ) | |
| (3,988,908 | ) | |
| (2,762,510 | ) |
Interest Income | |
| 119,453 | | |
| 27,234 | | |
| 235,633 | | |
| 46,809 | |
Net loss | |
$ | (1,628,373 | ) | |
$ | (746,073 | ) | |
$ | (3,753,275 | ) | |
$ | (2,715,701 | ) |
Per share information: | |
| | | |
| | | |
| | | |
| | |
Net loss per common share, basic and diluted | |
$ | (0.13 | ) | |
$ | (0.06 | ) | |
$ | (0.29 | ) | |
$ | (0.21 | ) |
Weighted average common shares outstanding,
basic and diluted | |
| 12,848,165 | | |
| 12,923,434 | | |
| 12,848,165 | | |
| 13,091,915 | |
See
accompanying notes to unaudited financial statements.
GREENWICH
LIFESCIENCES, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 AND 2022 (UNAUDITED)
| |
Shares | | |
Par
Amount | | |
Paid-in
Capital | | |
Accumulated
Deficit | | |
Stockholders’
Equity | |
| |
Common
Stock | |
Additional | | |
| | |
Total | |
| |
Shares | | |
Par
Amount | | |
Paid-in
Capital | | |
Accumulated
Deficit | | |
Stockholders’
Equity | |
| |
| | |
| | |
| | |
| | |
| |
Balances, December 31, 2021 | |
| 13,147,829 | | |
$ | 13,148 | | |
$ | 60,466,093 | | |
$ | (33,647,529 | ) | |
$ | 26,831,712 | |
Stock-based compensation | |
| 73,452 | | |
| 74 | | |
| 165,193 | | |
| — | | |
| 165,267 | |
Repurchase of common stock via stock buy back
program, net of costs | |
| (269,828 | ) | |
| (270 | ) | |
| (5,513,441 | ) | |
| — | | |
| (5,513,711 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| (1,969,628 | ) | |
| (1,969,628 | ) |
Balances, March 31, 2022 | |
| 12,951,453 | | |
$ | 12,952 | | |
$ | 55,117,845 | | |
$ | (35,617,157 | ) | |
$ | 19,513,640 | |
Stock-based compensation | |
| 73,356 | | |
| 73 | | |
| 224,430 | | |
| — | | |
| 224,503 | |
Repurchase of common
stock via stock buy back program, net of costs | |
| (250,000 | ) | |
| (250 | ) | |
| (2,022,255 | ) | |
| — | | |
| (2,022,505 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| (746,073 | ) | |
| (746,073 | ) |
Balances, June 30, 2022 | |
| 12,774,809 | | |
$ | 12,775 | | |
$ | 53,320,020 | | |
$ | (36,363,230 | ) | |
$ | 16,969,565 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balances, December 31, 2022 | |
| 12,848,165 | | |
$ | 12,848 | | |
$ | 54,674,042 | | |
$ | (41,472,766 | ) | |
$ | 13,214,124 | |
Stock-based compensation | |
| — | | |
| — | | |
| 594,522 | | |
| — | | |
| 594,522 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (2,124,902 | ) | |
| (2,124,902 | ) |
Balances, March 31, 2023 | |
| 12,848,165 | | |
$ | 12,848 | | |
$ | 55,268,564 | | |
$ | (43,597,668 | ) | |
$ | 11,683,744 | |
Balances | |
| 12,848,165 | | |
$ | 12,848 | | |
$ | 55,268,564 | | |
$ | (43,597,668 | ) | |
$ | 11,683,744 | |
Stock-based compensation | |
| — | | |
| — | | |
| 594,522 | | |
| — | | |
| 594,522 | |
Net loss | |
| — | | |
| — | | |
| — | | |
|
(1,628,373
| ) | |
|
(1,628,373
| ) |
Balances, June 30, 2023 | |
| 12,848,165 | | |
$ | 12,848 | | |
$ |
55,863,086
| | |
$ |
(45,226,041
| ) | |
$ |
10,649,893
| |
Balances | |
| 12,848,165 | | |
$ | 12,848 | | |
$ | 55,863,086 | | |
$ | (45,226,041 | ) | |
$ | 10,649,893 | |
See
accompanying notes to unaudited financial statements.
GREENWICH
LIFESCIENCES, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022 (UNAUDITED)
| |
2023 | | |
2022 | |
| |
Six
Months Ended June 30, | |
| |
2023 | | |
2022 | |
Operating activities: | |
| | | |
| | |
Net loss | |
$ | (3,753,275 | ) | |
$ | (2,715,701 | ) |
Adjustments required to reconcile net loss
to net cash used in operating activities: | |
| | | |
| | |
Amortization | |
| 1,806 | | |
| 1,806 | |
Stock-based compensation | |
| 1,189,044 | | |
| 389,770 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts Payable | |
| 79,618 | | |
| — | |
Unreimbursed expenses
(accrued) | |
| (40,977 | ) | |
| (156,038 | ) |
Net cash used in operating
activities | |
| (2,523,784 | ) | |
| (2,480,163 | ) |
Financing activities: | |
| | | |
| | |
Repurchase of common
stock via stock buy back program, net of costs | |
| — | | |
| (7,536,216 | ) |
Net cash provided by
(used in) financing activities | |
| — | | |
| (7,536,216 | ) |
Net increase (decrease) in cash | |
| (2,523,784 | ) | |
| (10,016,379 | ) |
Cash, beginning of period | |
| 13,468,026 | | |
| 27,204,269 | |
Cash, end of period | |
$ | 10,944,242 | | |
$ | 17,187,890 | |
See
accompanying notes to unaudited financial statements.
GREENWICH
LIFESCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS
(UNAUDITED)
1.
Organization and Description of the Business
Greenwich
LifeSciences, Inc. (the “Company”) was incorporated in the state of Delaware in 2006 under the name Norwell, Inc. In March
2018, Norwell, Inc. changed its name to Greenwich LifeSciences, Inc. In February 2023, Greenwich LifeSciences Europe Limited was incorporated
as a wholly owned subsidiary in Ireland. The Company is developing a breast cancer immunotherapy focused on preventing the recurrence
of breast cancer following surgery.
2.
Significant Accounting Policies
Basis
of Presentation
The
accompanying unaudited interim financial statements of the Company have been prepared in accordance with accounting principles generally
accepted in the United States of America and the rules of the Securities and Exchange Commission and should be read in conjunction with
the audited financial statements and notes thereto of the Company contained elsewhere herein.
In
the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial
position and the results of operations for the interim periods presented have been reflected herein. The results of operations for the
interim periods are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements that
would substantially duplicate the disclosures contained in the audited financial statements of the Company for the years ended December
31, 2022 and 2021 as reported in the Company’s Form 10-K have been omitted.
Leases
In
February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02-Leases (Topic 842), which significantly amends
the way companies are required to account for leases. Under the updated leasing guidance, some leases that did not have to be reported
previously are now required to be presented as an asset and liability on the balance sheet. In addition, for certain leases, what was
previously classified as an operating expense must now be allocated between amortization expense and interest expense. The Company elected
to adopt this update using the modified retrospective transition method and prior periods have not been restated. The current monthly
rent is approximately $2,555. The month-to-month sub-lease is from a related party and the underlying lease expires in May of 2024. Any
right of use asset and liability is deemed to be nominal as of June 30, 2023 and December 31, 2022.
Basic
and Diluted Loss per Share
Basic EPS is
computed by dividing net loss (numerator) by the weighted average number of common shares outstanding (denominator) during the period.
Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method. Diluted
EPS excludes all dilutive potential shares if their effect is antidilutive. During periods of net loss, all common stock equivalents related
to options and warrants outstanding of 20,174 as of June 30, 2023 and 2022 are excluded from the diluted EPS calculation because they
are antidilutive.
Recently
Adopted Accounting Pronouncements
In June 2016,
the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-13, “Financial Instruments
- Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). ASU 2016-13 requires
companies to measure credit losses utilizing a methodology that reflects expected credit losses and requires a consideration of a broader
range of reasonable and supportable information to inform credit loss estimates. ASU 2016-13 is effective for fiscal years beginning
after December 15, 2022, including interim periods within those fiscal years. The Company adopted ASU 2016-13 effective January 1, 2023.
The Company determined that the update applied to trade receivables, but that there was no material impact to the consolidated financial
statements from the adoption of ASU 2016-13.
3.
Related Party Transactions
Unreimbursed
expenses have been accrued and incurred by management, which total $1,083
as of June 30, 2023 and $42,060 as of December 31, 2022.
4.
Commitments and Contingencies
License
Obligation, Legal Expenses, and Manufacturing Agreements
The
Company entered into an exclusive license agreement with The Henry M. Jackson Foundation (“HJF”) in April 2009, as amended,
pursuant to which it acquired exclusive marketing rights to GP2, the Company’s product candidate. In consideration for such licensed
rights, the Company issued HJF 202,619 shares of the Company’s common stock valued at $0.267 per share, which is amortized over
15 years at $3,607 per year. Pursuant to the exclusive license agreement, the Company is required to pay an annual maintenance fee, milestone
payments and royalty payments based on sales of GP2 and to reimburse HJF for patent expenses related to GP2. The Company currently depends
on third-party contract manufacturers for all required raw materials, active pharmaceutical ingredients, and finished product candidate
for the Company’s clinical trials.
Accounts
payable includes accrued interest obligations to HJF which total $220,845 as of June 30, 2023 and December 31, 2022.
Legal
Proceedings
From
time to time, the Company may be involved in disputes, including litigation, relating to claims arising out of operations in the normal
course of business. Any of these claims could subject the Company to costly legal expenses and, while management generally believes that
there will be adequate insurance to cover different liabilities at such time the Company becomes a public company and commences clinical
trials, the Company’s future insurance carriers may deny coverage or policy limits may be inadequate to fully satisfy any damage
awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the results of
operations and financial position. Additionally, any such claims, whether or not successful, could damage the Company’s reputation
and business. The Company is currently not a party to any legal proceedings, the adverse outcome of which, in management’s opinion,
individually or in the aggregate, could have a material adverse effect on our results of operations or financial position.
5.
Stockholders’ Equity
As
of June 30, 2023, 893,181 shares of the 908,362 shares of the common stock grant, which includes an additional grant of 120 shares issued
during the vesting period due to rounding up of fractional shares, had vested at approximately $2,009,657 value and 15,181 shares remain
unvested and unrecognized at approximately $34,157 value. There were no shares vested during the six months ended June 30, 2023.
On
January 23, 2022, the Board of Directors authorized the Company’s management to implement a stock repurchase program for up to
$10
million of the Company’s common stock at
any time. The term of the Board of Directors authorization of the repurchase program ended on March 31, 2023. The repurchase program
may be suspended or discontinued at any time and will be funded using the Company’s working capital. As of June 30, 2023 and 2022,
approximately 519,828
shares of the Company’s common stock has
been repurchased and cancelled at an aggregate purchase price, including all transactions costs, of approximately $7,536,216.
There were no shares
repurchased during the six months ended June 30, 2023.
On
January 23, 2022, the Board of Directors extended the lock-up of the shares owned by the Company’s directors, officers, and existing
pre-IPO investors to March 24, 2023 (30 months from date of the Company’s IPO) from March 24, 2022 (18 months from date of the
Company’s IPO). On November 30, 2022, the Board of Directors further extended the lock-up of the shares owned by the Company’s
directors, officers, and existing pre-IPO investors to December 31, 2023 (approximately 39 months from date of the Company’s IPO)
from March 24, 2023 (30 months from date of the Company’s IPO). During this period, current officers, directors and certain shareholders
will not be able to sell their shares of the Company’s common stock unless otherwise modified by the Board of Directors.
Warrants
At
June 30, 2023, outstanding warrants to purchase shares of common stock were as follows with an
aggregate intrinsic value as of June 30, 2023 of $49,678 based on the June 30, 2023 closing share price of $9.65:
Schedule of Outstanding Warrants
Shares Underlying | | |
| | |
| |
Outstanding | | |
Exercise | | |
Expiration | |
Warrants | | |
Price(1) | | |
Date(1) | |
| | |
| | |
| |
20,174 | | |
$ | 7.1875 | | |
| September
24, 2025 | |
20,174 | | |
| | | |
| | |
Options
On
June 22, 2022, prior to the close of the Nasdaq market, 1,498,128 shares of common stock were granted to employees, consultants, and
directors issuable upon exercise of outstanding stock options under the Company’s 2019 Equity Incentive Plan at an exercise price
of $7.63 per share, which was the most recent prior closing share price on June 21, 2022. The options had a fair value on the grant date
of $9,512,356, based on a risk-free rate of 3.2% and an annualized volatility of 106%, of which $2,437,540 was expensed through June
30, 2023 and $7,074,816 will be expensed in the future if and as vesting occurs. Vesting will be based on time of service over a four
year period and certain additional performance milestones for senior management, primarily related to the Phase III clinical trial.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q includes 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”).
All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding the future
financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The
words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“intend,” “should,” “plan,” “expect,” and similar expressions, as they relate to us,
are intended to identify forward-looking statements. We have based these forward-looking statements largely on current expectations and
projections about future events and financial trends that we believe may affect our financial condition, results of operations, business
strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions.
In
addition, our business and financial performance may be affected by the factors that are discussed under “Risk Factors” in
the Annual Report on Form 10-K for the year ended December 31, 2022, filed on March 31, 2023. Moreover, we operate in a very competitive
and rapidly changing environment. New risk factors emerge from time to time and it is not possible for us to predict all risk factors,
nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any forward-looking statements.
You
should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances
reflected in the forward-looking statements will be achieved or occur. 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.
The
following discussion and analysis is qualified in its entirety by, and should be read in conjunction with, the more detailed information
set forth in the financial statements and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q. This discussion
should not be construed to imply that the results discussed herein will necessarily continue into the future, or that any conclusion
reached herein will necessarily be indicative of actual operating results in the future. Such discussion represents only the best present
assessment of our management.
Overview
We
are a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences
in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell
surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+),
intermediate (2+), and high (3+ or over-expressor) levels. The combination of GP2 + GM-CSF is called GLSI-100. In a completed randomized,
single-blinded, placebo-controlled, multi-center Phase IIb clinical trial led by MD Anderson Cancer Center, no recurrences were observed
in patients treated with GLSI-100 in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patients were
treated, followed, and remained disease free over the first 6 months, which is the time required to reach peak immunity and thus maximum
efficacy and protection (p = 0.0338). For the 146 patients who have been treated with GLSI-100 to date over 4 clinical trials, treatment
was well tolerated and no serious adverse events were observed related to the immunotherapy.
We
have commenced Flamingo-01, a Phase III clinical trial with Baylor College of Medicine as the global primary investigator site. Flamingo-01
is designed to evaluate the safety and efficacy of GLSI-100 in HER2/neu positive patients with residual disease or high-risk pathologic
complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment.
To
date, we have not generated any revenue and we have incurred net losses. Our net losses were approximately $7.8 million and $4.6 million
for the years ended December 31, 2022 and 2021, respectively and $3.8 million and $2.7 million for the six months ended June 30, 2023
and 2022, respectively.
Our
net losses have resulted from costs incurred in developing the drug in our pipeline, planning and preparing for clinical trials and general
and administrative activities associated with our operations. We expect to continue to incur significant expenses and corresponding increased
operating losses for the foreseeable future as we continue to develop our pipeline. Our costs may further increase as we conduct clinical
trials and seek regulatory approval for and prepare to commercialize our product candidate. We expect to incur significant expenses to
continue to build the infrastructure necessary to support our expanded operations, clinical trials, commercialization, including manufacturing,
marketing, sales and distribution functions. We will also experience increased costs associated with operating as a public company.
Results
of Operations for the Three Months Ended June 30, 2023 and 2022
Research
and Development Expenses
Research
and development expenses increased by $746,317 or 118%, to $1,379,567 for the three months ended June 30, 2023 from $633,250 for the three
months ended June 30, 2022. The increase was primarily the result of an increase in compensation, clinical, and manufacturing expenses.
General
and Administrative Expenses
General
and administrative expenses increased by $228,202, or 163%, to $368,259 for the three months ended June 30, 2023 from
$140,057 for the three months ended June 30, 2022. The increase was primarily the result of an increase
in compensation, financing, and corporate expenses.
Results
of Operations for the Six Months Ended June 30, 2023 and 2022
Research
and Development Expenses
Research
and development expenses increased by $913,403, or 40%, to $3,207,474 for the six months ended June 30, 2023 from $2,294,071 for the
six months ended June 30, 2022. The increase was primarily the result of an increase in compensation, clinical, and manufacturing
expenses.
General
and Administrative Expenses
General
and administrative expenses increased by $312,995, or 67%, to $781,434 for the six months ended June 30, 2023 from $468,439 for the six
months ended June 30, 2022. The increase was primarily the result of an increase in compensation, financing, and corporate expenses.
Liquidity
and Capital Resources
Since
our inception in 2006, we have devoted most of our cash resources to research and development and general and administrative activities.
We have not yet achieved commercialization of our product and have a cumulative net loss from our operations. We will continue to incur
net losses for the foreseeable future. Our financial statements have been prepared assuming that we will continue as a going concern.
We
will require additional capital to meet our long-term operating requirements. We expect to raise additional capital through the sale
of equity and/or debt securities; however, there is no assurance that we will be successful at raising additional capital in the
future. If our plans are not achieved and/or if significant unanticipated events occur, we may have to further modify our business
plan, which may require us to raise additional capital. As of June 30, 2023 and December 31, 2022, our principal source of liquidity
was our cash, which totaled $10,944,242 and $13,468,026, respectively, and additional loans and accrued unreimbursed expenses from
related parties. Historically, our principal sources of cash have included proceeds from the sale of common stock and preferred
stock and related party loans. Our principal uses of cash have included cash used in operations. We expect that the principal uses
of cash in the future will be for continuing operations, funding of research and development, including our clinical trials, and
general working capital requirements. The Company’s existing cash
resources are expected to provide sufficient funds to carry the Company’s planned operations over the next 12 months from the date
these financial statements were issued.
Cash
Flow Activities for the Six Months Ended June 30, 2023 and 2022
We
incurred net losses of $3,753,275 and $2,715,701 during the six month periods ended June 30, 2023 and 2022, respectively. The
increase was primarily the result of an increase in compensation, clinical, manufacturing, financing, and corporate expenses.
Operating
Activities
Net
cash used in operating activities was $2,523,784 for the six months ended June 30, 2023 and $2,480,163 for the six months ended June
30, 2022.
Investing
Activities
We
did not use or generate cash from investing activities during the six months ended June 30, 2023 and June 30, 2022.
Financing
Activities
We
used a total of $0 and $7,536,216 cash for the stock buy back program, net of costs, during the six months ended June 30, 2023 and June
30, 2022, respectively.
Contractual
Obligations and Commitments
As
of June 30, 2023, we did not have any material contractual obligations, other than employment and shareholder agreements, license for
GP2 from HJF, and manufacturing and clinical trial obligations related to the planned Phase III clinical trial.
Off-Balance
Sheet Arrangements
As
of June 30, 2023, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.
Critical
Accounting Policies and Estimates
Our
financial statements are prepared in conformity with U.S. GAAP, which require the use of estimates, judgments and assumptions that affect
the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements, and
the reported amounts of expenses in the periods presented.
On
an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation.
We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts
of expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the
significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic and the COVID-19 control
responses.
Recent
Accounting Pronouncements
In June 2016, the Financial Accounting
Standards Board (“FASB”) issued Accounting Standards Update 2016-13, “Financial Instruments - Credit Losses (Topic 326):
Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). ASU 2016-13 requires companies to measure credit
losses utilizing a methodology that reflects expected credit losses and requires a consideration of a broader range of reasonable and
supportable information to inform credit loss estimates. ASU 2016-13 is effective for fiscal years beginning after December 15, 2022,
including interim periods within those fiscal years. The Company adopted ASU 2016-13 effective January 1, 2023. The Company determined
that the update applied to trade receivables, but that there was no material impact to the consolidated financial statements from the
adoption of ASU 2016-13.
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standard Board or other standard setting bodies that
the Company adopts as of the specified effective date. The Company does not believe that the impact of recently issued standards that
are not yet effective will have a material impact on the Company’s financial position or results of operations upon adoption.
JOBS
Act
On
April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take
advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (“Securities
Act”) for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay
the adoption of certain accounting standards until those standards would otherwise apply to private companies.
We
have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying
with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act.
As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for
complying with new or revised accounting standards.
Subject
to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions,
including, without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial
reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public
Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement to the auditor’s
report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We
will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total
annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the
completion of our initial public offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during
the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We
are a smaller reporting company, as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to
provide the information required under this Item 3.
ITEM
4. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures
We
maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act that
are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange
Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure
controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed
by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including
our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Our
management, with the participation of our principal executive officer and principal accounting and financial officer, has evaluated the
effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of the
end of the period covered by this Quarterly Report on Form 10-Q. Based on such evaluation, our principal executive officer and principal
accounting and financial officer has concluded that as of June 30, 2023, our disclosure controls and procedures were not effective as
of such date as a result of material weaknesses in our internal control over financial reporting due to inadequate segregation of duties
within account processes due to limited personnel and insufficient written policies and procedures for accounting, IT and financial reporting
and record keeping. Under the direction of our principal executive officer and principal financial and accounting officer, we are developing
a plan to remediate the material weaknesses.
Changes
in Internal Control over Financial Reporting
There
was no change in our internal control over financial reporting during our most recent fiscal quarter that materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
Limitations
on Effectiveness of Controls and Procedures
Our
disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives as specified above. Management
does not expect, however, that our disclosure controls and procedures will prevent or detect all errors and fraud. Any control system,
no matter how well designed and operated, is based upon certain assumptions and can provide only reasonable, not absolute, assurance
that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or
fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected.
PART
II. OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
From
time to time, we may be subject to litigation and claims arising in the ordinary course of business. We are not currently a party to
any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have
a material adverse effect on our business, operating results, cash flows or financial condition.
ITEM
1A. RISK FACTORS
There
have been no material changes from the risk factors disclosed in our Form 10-K for the year ended December 31, 2022.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. MINE SAFETY DISCLOSURES
Not
applicable.
ITEM
5. OTHER INFORMATION
Securities
Trading Plans of Directors and Executive Officers
During
the three months ended June 30, 2023, none of our directors or executive officers adopted or terminated any contract, instruction or
written plan for the purchase or sale of GLSI securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c)
or any “non-Rule 10b5-1 trading arrangement.”
ITEM
6. EXHIBITS
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.
|
GREENWICH
LIFESCIENCES, INC. |
|
|
|
August
21, 2023 |
By: |
/s/
Snehal Patel |
|
|
Snehal
Patel |
|
|
Chief
Executive Officer (Principal Executive Officer and Principal Accounting and Financial Officer) |
Exhibit
31.1
Certification
of Chief Executive Officer and Principal Financial and Accounting Officer of Greenwich LifeSciences, Inc.
Pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
I,
Snehal Patel, certify that:
1. |
I
have reviewed this quarterly report on Form 10-Q of Greenwich LifeSciences, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer 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 15(d)-15(f)) for the registrant and have: |
|
a. |
|
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
|
b. |
|
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
|
c. |
|
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures, and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
|
d. |
|
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a. |
|
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
|
b. |
|
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
August
21, 2023 |
/s/
Snehal Patel |
|
Snehal
Patel, Chief Executive Officer (Principal Executive Officer and Principal Financial and Accounting Officer) |
Exhibit
32.1
Statement
of Chief Executive Officer and Principal Financial and Accounting Officer
Pursuant to Section 1350 of Title 18 of the United States Code
Pursuant
to Section 1350 of Title 18 of the United States Code as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned,
Snehal Patel, the Chief Executive Officer and Principal Financial and Accounting Officer of Greenwich LifeSciences, Inc. (the “Company”),
hereby certifies that based on the undersigned’s knowledge:
1. |
The
Company’s quarterly report on Form 10-Q for the period ended June 30, 2023 (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. |
August
21, 2023 |
/s/
Snehal Patel |
|
Snehal
Patel |
|
Chief
Executive Officer |
|
(Principal
Executive Officer and Principal Financial and Accounting Officer ) |
v3.23.2
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2023 |
Aug. 15, 2023 |
Cover [Abstract] |
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|
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|
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Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
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Entity File Number |
001-39555
|
|
Entity Registrant Name |
GREENWICH
LIFESCIENCES, INC.
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Entity Central Index Key |
0001799788
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20-5473709
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DE
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3992
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Common
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GLSI
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v3.23.2
Consolidated Balance Sheets (Unaudited) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets |
|
|
Cash |
$ 10,944,242
|
$ 13,468,026
|
Non-current assets |
|
|
Acquired patents, net |
7,197
|
9,003
|
Total assets |
10,951,439
|
13,477,029
|
Current liabilities |
|
|
Accounts payable & accrued interest |
300,463
|
220,845
|
Unreimbursed expenses |
1,083
|
42,060
|
Total current liabilities |
301,546
|
262,905
|
Total liabilities |
301,546
|
262,905
|
Stockholders’ equity |
|
|
Common stock, $0.001 par value; 100,000,000 shares authorized; 12,848,165 shares issued and outstanding as of June 30, 2023 and December 31, 2022 |
12,848
|
12,848
|
Additional paid-in capital |
55,863,086
|
54,674,042
|
Accumulated deficit |
(45,226,041)
|
(41,472,766)
|
Total stockholders’ equity |
10,649,893
|
13,214,124
|
Total liabilities and stockholders’ equity |
$ 10,951,439
|
$ 13,477,029
|
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v3.23.2
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|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common stock, shares issued |
12,848,165
|
12,848,165
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12,848,165
|
12,848,165
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v3.23.2
Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Revenue |
|
|
|
|
Operating expenses |
|
|
|
|
Research and development |
1,379,567
|
633,250
|
3,207,474
|
2,294,071
|
General and administrative |
368,259
|
140,057
|
781,434
|
468,439
|
Total operating expenses |
1,747,826
|
773,307
|
3,988,908
|
2,762,510
|
Loss from operations |
(1,747,826)
|
(773,307)
|
(3,988,908)
|
(2,762,510)
|
Interest Income |
119,453
|
27,234
|
235,633
|
46,809
|
Net loss |
$ (1,628,373)
|
$ (746,073)
|
$ (3,753,275)
|
$ (2,715,701)
|
Per share information: |
|
|
|
|
Net loss per common share, basic |
$ (0.13)
|
$ (0.06)
|
$ (0.29)
|
$ (0.21)
|
Net loss per common share, diluted |
$ (0.13)
|
$ (0.06)
|
$ (0.29)
|
$ (0.21)
|
Weighted average common shares outstanding, basic |
12,848,165
|
12,923,434
|
12,848,165
|
13,091,915
|
Weighted average common shares outstanding, diluted |
12,848,165
|
12,923,434
|
12,848,165
|
13,091,915
|
X |
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v3.23.2
Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balances at Dec. 31, 2021 |
$ 13,148
|
$ 60,466,093
|
$ (33,647,529)
|
$ 26,831,712
|
Balance, shares at Dec. 31, 2021 |
13,147,829
|
|
|
|
Stock-based compensation |
$ 74
|
165,193
|
|
165,267
|
Stock-based compensation, shares |
73,452
|
|
|
|
Repurchase of common stock via stock buy back program, net of costs |
$ (270)
|
(5,513,441)
|
|
(5,513,711)
|
Repurchase of common stock via stock buy back program, net of costs, shares |
(269,828)
|
|
|
|
Net loss |
|
|
(1,969,628)
|
(1,969,628)
|
Balances at Mar. 31, 2022 |
$ 12,952
|
55,117,845
|
(35,617,157)
|
19,513,640
|
Balance, shares at Mar. 31, 2022 |
12,951,453
|
|
|
|
Balances at Dec. 31, 2021 |
$ 13,148
|
60,466,093
|
(33,647,529)
|
26,831,712
|
Balance, shares at Dec. 31, 2021 |
13,147,829
|
|
|
|
Net loss |
|
|
|
(2,715,701)
|
Balances at Jun. 30, 2022 |
$ 12,775
|
53,320,020
|
(36,363,230)
|
16,969,565
|
Balance, shares at Jun. 30, 2022 |
12,774,809
|
|
|
|
Balances at Mar. 31, 2022 |
$ 12,952
|
55,117,845
|
(35,617,157)
|
19,513,640
|
Balance, shares at Mar. 31, 2022 |
12,951,453
|
|
|
|
Stock-based compensation |
$ 73
|
224,430
|
|
224,503
|
Stock-based compensation, shares |
73,356
|
|
|
|
Repurchase of common stock via stock buy back program, net of costs |
$ (250)
|
(2,022,255)
|
|
(2,022,505)
|
Repurchase of common stock via stock buy back program, net of costs, shares |
(250,000)
|
|
|
|
Net loss |
|
|
(746,073)
|
(746,073)
|
Balances at Jun. 30, 2022 |
$ 12,775
|
53,320,020
|
(36,363,230)
|
16,969,565
|
Balance, shares at Jun. 30, 2022 |
12,774,809
|
|
|
|
Balances at Dec. 31, 2022 |
$ 12,848
|
54,674,042
|
(41,472,766)
|
13,214,124
|
Balance, shares at Dec. 31, 2022 |
12,848,165
|
|
|
|
Stock-based compensation |
|
594,522
|
|
594,522
|
Stock-based compensation, shares |
|
|
|
|
Net loss |
|
|
(2,124,902)
|
(2,124,902)
|
Balances at Mar. 31, 2023 |
$ 12,848
|
55,268,564
|
(43,597,668)
|
11,683,744
|
Balance, shares at Mar. 31, 2023 |
12,848,165
|
|
|
|
Balances at Dec. 31, 2022 |
$ 12,848
|
54,674,042
|
(41,472,766)
|
$ 13,214,124
|
Balance, shares at Dec. 31, 2022 |
12,848,165
|
|
|
|
Repurchase of common stock via stock buy back program, net of costs, shares |
|
|
|
0
|
Net loss |
|
|
|
$ (3,753,275)
|
Balances at Jun. 30, 2023 |
$ 12,848
|
55,863,086
|
(45,226,041)
|
10,649,893
|
Balance, shares at Jun. 30, 2023 |
12,848,165
|
|
|
|
Balances at Mar. 31, 2023 |
$ 12,848
|
55,268,564
|
(43,597,668)
|
11,683,744
|
Balance, shares at Mar. 31, 2023 |
12,848,165
|
|
|
|
Stock-based compensation |
|
594,522
|
|
594,522
|
Stock-based compensation, shares |
|
|
|
|
Net loss |
|
|
(1,628,373)
|
(1,628,373)
|
Balances at Jun. 30, 2023 |
$ 12,848
|
$ 55,863,086
|
$ (45,226,041)
|
$ 10,649,893
|
Balance, shares at Jun. 30, 2023 |
12,848,165
|
|
|
|
X |
- DefinitionThe portion of profit or loss for the period, net of income taxes, which is attributable to the parent.
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v3.23.2
Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Operating activities: |
|
|
|
|
|
|
Net loss |
$ (1,628,373)
|
$ (2,124,902)
|
$ (746,073)
|
$ (1,969,628)
|
$ (3,753,275)
|
$ (2,715,701)
|
Adjustments required to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
Amortization |
|
|
|
|
1,806
|
1,806
|
Stock-based compensation |
|
|
|
|
1,189,044
|
389,770
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Accounts Payable |
|
|
|
|
79,618
|
|
Unreimbursed expenses (accrued) |
|
|
|
|
(40,977)
|
(156,038)
|
Net cash used in operating activities |
|
|
|
|
(2,523,784)
|
(2,480,163)
|
Financing activities: |
|
|
|
|
|
|
Repurchase of common stock via stock buy back program, net of costs |
|
|
|
|
|
(7,536,216)
|
Net cash provided by (used in) financing activities |
|
|
|
|
|
(7,536,216)
|
Net increase (decrease) in cash |
|
|
|
|
(2,523,784)
|
(10,016,379)
|
Cash, beginning of period |
|
$ 13,468,026
|
|
$ 27,204,269
|
13,468,026
|
27,204,269
|
Cash, end of period |
$ 10,944,242
|
|
$ 17,187,890
|
|
$ 10,944,242
|
$ 17,187,890
|
X |
- DefinitionThe aggregate amount of recurring noncash expense charged against earnings in the period to allocate the cost of assets over their estimated remaining economic lives.
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v3.23.2
Organization and Description of the Business
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization and Description of the Business |
1.
Organization and Description of the Business
Greenwich
LifeSciences, Inc. (the “Company”) was incorporated in the state of Delaware in 2006 under the name Norwell, Inc. In March
2018, Norwell, Inc. changed its name to Greenwich LifeSciences, Inc. In February 2023, Greenwich LifeSciences Europe Limited was incorporated
as a wholly owned subsidiary in Ireland. The Company is developing a breast cancer immunotherapy focused on preventing the recurrence
of breast cancer following surgery.
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- DefinitionThe entire disclosure for organization, consolidation and basis of presentation of financial statements disclosure.
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v3.23.2
Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Significant Accounting Policies |
2.
Significant Accounting Policies
Basis
of Presentation
The
accompanying unaudited interim financial statements of the Company have been prepared in accordance with accounting principles generally
accepted in the United States of America and the rules of the Securities and Exchange Commission and should be read in conjunction with
the audited financial statements and notes thereto of the Company contained elsewhere herein.
In
the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial
position and the results of operations for the interim periods presented have been reflected herein. The results of operations for the
interim periods are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements that
would substantially duplicate the disclosures contained in the audited financial statements of the Company for the years ended December
31, 2022 and 2021 as reported in the Company’s Form 10-K have been omitted.
Leases
In
February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02-Leases (Topic 842), which significantly amends
the way companies are required to account for leases. Under the updated leasing guidance, some leases that did not have to be reported
previously are now required to be presented as an asset and liability on the balance sheet. In addition, for certain leases, what was
previously classified as an operating expense must now be allocated between amortization expense and interest expense. The Company elected
to adopt this update using the modified retrospective transition method and prior periods have not been restated. The current monthly
rent is approximately $2,555. The month-to-month sub-lease is from a related party and the underlying lease expires in May of 2024. Any
right of use asset and liability is deemed to be nominal as of June 30, 2023 and December 31, 2022.
Basic
and Diluted Loss per Share
Basic EPS is
computed by dividing net loss (numerator) by the weighted average number of common shares outstanding (denominator) during the period.
Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method. Diluted
EPS excludes all dilutive potential shares if their effect is antidilutive. During periods of net loss, all common stock equivalents related
to options and warrants outstanding of 20,174 as of June 30, 2023 and 2022 are excluded from the diluted EPS calculation because they
are antidilutive.
Recently
Adopted Accounting Pronouncements
In June 2016,
the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-13, “Financial Instruments
- Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). ASU 2016-13 requires
companies to measure credit losses utilizing a methodology that reflects expected credit losses and requires a consideration of a broader
range of reasonable and supportable information to inform credit loss estimates. ASU 2016-13 is effective for fiscal years beginning
after December 15, 2022, including interim periods within those fiscal years. The Company adopted ASU 2016-13 effective January 1, 2023.
The Company determined that the update applied to trade receivables, but that there was no material impact to the consolidated financial
statements from the adoption of ASU 2016-13.
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X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.2
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
4.
Commitments and Contingencies
License
Obligation, Legal Expenses, and Manufacturing Agreements
The
Company entered into an exclusive license agreement with The Henry M. Jackson Foundation (“HJF”) in April 2009, as amended,
pursuant to which it acquired exclusive marketing rights to GP2, the Company’s product candidate. In consideration for such licensed
rights, the Company issued HJF 202,619 shares of the Company’s common stock valued at $0.267 per share, which is amortized over
15 years at $3,607 per year. Pursuant to the exclusive license agreement, the Company is required to pay an annual maintenance fee, milestone
payments and royalty payments based on sales of GP2 and to reimburse HJF for patent expenses related to GP2. The Company currently depends
on third-party contract manufacturers for all required raw materials, active pharmaceutical ingredients, and finished product candidate
for the Company’s clinical trials.
Accounts
payable includes accrued interest obligations to HJF which total $220,845 as of June 30, 2023 and December 31, 2022.
Legal
Proceedings
From
time to time, the Company may be involved in disputes, including litigation, relating to claims arising out of operations in the normal
course of business. Any of these claims could subject the Company to costly legal expenses and, while management generally believes that
there will be adequate insurance to cover different liabilities at such time the Company becomes a public company and commences clinical
trials, the Company’s future insurance carriers may deny coverage or policy limits may be inadequate to fully satisfy any damage
awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the results of
operations and financial position. Additionally, any such claims, whether or not successful, could damage the Company’s reputation
and business. The Company is currently not a party to any legal proceedings, the adverse outcome of which, in management’s opinion,
individually or in the aggregate, could have a material adverse effect on our results of operations or financial position.
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v3.23.2
Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Stockholders’ Equity |
5.
Stockholders’ Equity
As
of June 30, 2023, 893,181 shares of the 908,362 shares of the common stock grant, which includes an additional grant of 120 shares issued
during the vesting period due to rounding up of fractional shares, had vested at approximately $2,009,657 value and 15,181 shares remain
unvested and unrecognized at approximately $34,157 value. There were no shares vested during the six months ended June 30, 2023.
On
January 23, 2022, the Board of Directors authorized the Company’s management to implement a stock repurchase program for up to
$10
million of the Company’s common stock at
any time. The term of the Board of Directors authorization of the repurchase program ended on March 31, 2023. The repurchase program
may be suspended or discontinued at any time and will be funded using the Company’s working capital. As of June 30, 2023 and 2022,
approximately 519,828
shares of the Company’s common stock has
been repurchased and cancelled at an aggregate purchase price, including all transactions costs, of approximately $7,536,216.
There were no shares
repurchased during the six months ended June 30, 2023.
On
January 23, 2022, the Board of Directors extended the lock-up of the shares owned by the Company’s directors, officers, and existing
pre-IPO investors to March 24, 2023 (30 months from date of the Company’s IPO) from March 24, 2022 (18 months from date of the
Company’s IPO). On November 30, 2022, the Board of Directors further extended the lock-up of the shares owned by the Company’s
directors, officers, and existing pre-IPO investors to December 31, 2023 (approximately 39 months from date of the Company’s IPO)
from March 24, 2023 (30 months from date of the Company’s IPO). During this period, current officers, directors and certain shareholders
will not be able to sell their shares of the Company’s common stock unless otherwise modified by the Board of Directors.
Warrants
At
June 30, 2023, outstanding warrants to purchase shares of common stock were as follows with an
aggregate intrinsic value as of June 30, 2023 of $49,678 based on the June 30, 2023 closing share price of $9.65:
Schedule of Outstanding Warrants
Shares Underlying | | |
| | |
| |
Outstanding | | |
Exercise | | |
Expiration | |
Warrants | | |
Price(1) | | |
Date(1) | |
| | |
| | |
| |
20,174 | | |
$ | 7.1875 | | |
| September
24, 2025 | |
20,174 | | |
| | | |
| | |
(1) |
The
warrants are exercisable at any time and from time to time, in whole or in part, during a period commencing March 24, 2021 and expiring
September 24, 2025. The exercise price of the warrants is $7.1875 per share or $6.9718 per share if the warrants are exercised for
cash within the first six months of the period in which they are exercisable. |
Options
On
June 22, 2022, prior to the close of the Nasdaq market, 1,498,128 shares of common stock were granted to employees, consultants, and
directors issuable upon exercise of outstanding stock options under the Company’s 2019 Equity Incentive Plan at an exercise price
of $7.63 per share, which was the most recent prior closing share price on June 21, 2022. The options had a fair value on the grant date
of $9,512,356, based on a risk-free rate of 3.2% and an annualized volatility of 106%, of which $2,437,540 was expensed through June
30, 2023 and $7,074,816 will be expensed in the future if and as vesting occurs. Vesting will be based on time of service over a four
year period and certain additional performance milestones for senior management, primarily related to the Phase III clinical trial.
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v3.23.2
Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
The
accompanying unaudited interim financial statements of the Company have been prepared in accordance with accounting principles generally
accepted in the United States of America and the rules of the Securities and Exchange Commission and should be read in conjunction with
the audited financial statements and notes thereto of the Company contained elsewhere herein.
In
the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial
position and the results of operations for the interim periods presented have been reflected herein. The results of operations for the
interim periods are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements that
would substantially duplicate the disclosures contained in the audited financial statements of the Company for the years ended December
31, 2022 and 2021 as reported in the Company’s Form 10-K have been omitted.
|
Leases |
Leases
In
February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02-Leases (Topic 842), which significantly amends
the way companies are required to account for leases. Under the updated leasing guidance, some leases that did not have to be reported
previously are now required to be presented as an asset and liability on the balance sheet. In addition, for certain leases, what was
previously classified as an operating expense must now be allocated between amortization expense and interest expense. The Company elected
to adopt this update using the modified retrospective transition method and prior periods have not been restated. The current monthly
rent is approximately $2,555. The month-to-month sub-lease is from a related party and the underlying lease expires in May of 2024. Any
right of use asset and liability is deemed to be nominal as of June 30, 2023 and December 31, 2022.
|
Basic and Diluted Loss per Share |
Basic
and Diluted Loss per Share
Basic EPS is
computed by dividing net loss (numerator) by the weighted average number of common shares outstanding (denominator) during the period.
Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method. Diluted
EPS excludes all dilutive potential shares if their effect is antidilutive. During periods of net loss, all common stock equivalents related
to options and warrants outstanding of 20,174 as of June 30, 2023 and 2022 are excluded from the diluted EPS calculation because they
are antidilutive.
|
Recently Adopted Accounting Pronouncements |
Recently
Adopted Accounting Pronouncements
In June 2016,
the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-13, “Financial Instruments
- Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). ASU 2016-13 requires
companies to measure credit losses utilizing a methodology that reflects expected credit losses and requires a consideration of a broader
range of reasonable and supportable information to inform credit loss estimates. ASU 2016-13 is effective for fiscal years beginning
after December 15, 2022, including interim periods within those fiscal years. The Company adopted ASU 2016-13 effective January 1, 2023.
The Company determined that the update applied to trade receivables, but that there was no material impact to the consolidated financial
statements from the adoption of ASU 2016-13.
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Stockholders’ Equity (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Schedule of Outstanding Warrants |
Schedule of Outstanding Warrants
Shares Underlying | | |
| | |
| |
Outstanding | | |
Exercise | | |
Expiration | |
Warrants | | |
Price(1) | | |
Date(1) | |
| | |
| | |
| |
20,174 | | |
$ | 7.1875 | | |
| September
24, 2025 | |
20,174 | | |
| | | |
| | |
(1) |
The
warrants are exercisable at any time and from time to time, in whole or in part, during a period commencing March 24, 2021 and expiring
September 24, 2025. The exercise price of the warrants is $7.1875 per share or $6.9718 per share if the warrants are exercised for
cash within the first six months of the period in which they are exercisable. |
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v3.23.2
v3.23.2
Commitments and Contingencies (Details Narrative) - USD ($)
|
1 Months Ended |
6 Months Ended |
|
Apr. 30, 2009 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Amortized value |
|
$ 1,806
|
$ 1,806
|
|
Accounts payable and accrued liabilities |
|
$ 220,845
|
|
$ 220,845
|
License Agreement [Member] | The Henry M. Jackson Foundation ("HJF") [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Shares issued during period common stock |
202,619
|
|
|
|
Price per share |
$ 0.267
|
|
|
|
Amortized period |
15 years
|
|
|
|
Amortized value |
$ 3,607
|
|
|
|
X |
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v3.23.2
Stockholders’ Equity (Details Narrative) - USD ($)
|
|
|
3 Months Ended |
6 Months Ended |
Jun. 22, 2022 |
Jan. 23, 2022 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Number of shares vested |
|
|
|
|
893,181
|
Number of options granted |
|
|
|
|
908,362
|
Number of additional shares granted |
|
|
|
|
120
|
Share based compensation expenses in future if vesting occurs |
|
|
|
|
$ 2,009,657
|
Number of unvested shares outstanding |
|
|
|
|
15,181
|
Unrecognized value of shares |
|
|
|
|
$ 34,157
|
Stock Repurchased During Period, Value |
|
|
$ 2,022,505
|
$ 5,513,711
|
|
Stock Repurchase Program, Number of Shares Authorized to be Repurchased |
|
|
519,828
|
|
519,828
|
Stock Repurchase Program, Remaining Authorized Repurchase Amount |
|
|
|
|
$ 7,536,216
|
Stock Repurchased During Period, Shares |
|
|
|
|
0
|
Value of outstanding warrants |
|
|
|
|
$ 49,678
|
Closing share price |
|
|
|
|
$ 9.65
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
Number of options granted |
1,498,128
|
|
|
|
|
Share based compensation expenses in future if vesting occurs |
|
|
|
|
$ 7,074,816
|
Options exercise price |
$ 7.63
|
|
|
|
|
Shares granted, value |
|
|
|
|
$ 9,512,356
|
Risk-free rate |
|
|
|
|
3.20%
|
Volatility rate |
|
|
|
|
106.00%
|
Share based expense, value |
|
|
|
|
$ 2,437,540
|
Maximum [Member] |
|
|
|
|
|
Stock Repurchased During Period, Value |
|
$ 10
|
|
|
|
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Greenwich LifeSciences (NASDAQ:GLSI)
過去 株価チャート
から 4 2024 まで 5 2024
Greenwich LifeSciences (NASDAQ:GLSI)
過去 株価チャート
から 5 2023 まで 5 2024