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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 March 31, 2026
| ☐ |
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
of
incorporation or organization) |
|
(I.R.S.
Employer
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 May 26, 2026, the issuer had 14,678,208 shares of Common Stock issued and outstanding.
GREENWICH
LIFESCIENCES, INC.
Table
of Contents
| |
|
Page |
| PART I |
FINANCIAL INFORMATION |
3 |
| |
|
|
| Item 1. |
Financial Statements (unaudited) |
3 |
| |
|
|
| |
Balance
Sheets as of March 31, 2026 and December 31, 2025 (Unaudited) |
3 |
| |
|
|
| |
Statements of Operations for the Three Months Ended March 31, 2026 and 2025 (Unaudited) |
4 |
| |
|
|
| |
Statements of Stockholders’ Equity for the Three Months Ended March 31, 2026 and 2025 (Unaudited) |
5 |
| |
|
|
| |
Statements of Cash Flows for the Three Months Ended March 31, 2026 and 2025 (Unaudited) |
6 |
| |
|
|
| |
Notes to Financial Statements (Unaudited) |
7 |
| |
|
|
| Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
10 |
| |
|
|
| Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
13 |
| |
|
|
| Item 4. |
Controls and Procedures |
13 |
| |
|
|
| PART II |
OTHER INFORMATION |
14 |
| |
|
|
| Item 1. |
Legal Proceedings |
14 |
| |
|
|
| Item 1A. |
Risk Factors |
14 |
| |
|
|
| Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
14 |
| |
|
|
| Item 3. |
Defaults Upon Senior Securities |
14 |
| |
|
|
| Item 4. |
Mine Safety Disclosures |
14 |
| |
|
|
| Item 5. |
Other Information |
14 |
| |
|
|
| Item 6: |
Exhibits |
15 |
| |
|
|
| SIGNATURES |
16 |
PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
GREENWICH
LIFESCIENCES, INC.
BALANCE
SHEETS
AS
OF MARCH 31, 2026 AND DECEMBER 31, 2025 (UNAUDITED)
| | |
March 31, 2026 | | |
December 31, 2025 | |
| Assets | |
| | | |
| | |
| Current assets | |
| | | |
| | |
| Cash | |
$ | 10,505,435 | | |
$ | 6,178,021 | |
| Total current assets | |
| 10,505,435 | | |
| 6,178,021 | |
| Total assets | |
$ | 10,505,435 | | |
$ | 6,178,021 | |
| | |
| | | |
| | |
| Liabilities and stockholders’ equity | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Accounts payable & accrued interest | |
$ | 4,509,028 | | |
$ | 4,874,489 | |
| Deferred compensation | |
| 673,819 | | |
| 673,819 | |
| Unreimbursed expenses | |
| 52,382 | | |
| 276,496 | |
| Total current liabilities | |
| 5,235,229 | | |
| 5,824,804 | |
| Total liabilities | |
| 5,235,229 | | |
| 5,824,804 | |
| | |
| | | |
| | |
| Stockholders’ equity | |
| | | |
| | |
| | |
| | | |
| | |
| Common stock, $0.001 par value; 100,000,000 shares authorized; 14,665,993 and 14,298,446 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively | |
| 14,666 | | |
| 14,299 | |
| | |
| | | |
| | |
| Additional paid-in capital | |
| 98,049,683 | | |
| 87,475,924 | |
| Accumulated deficit | |
| (92,794,143 | ) | |
| (87,137,006 | ) |
| Total stockholders’ equity | |
| 5,270,206 | | |
| 353,217 | |
| Total liabilities and stockholders’ equity | |
$ | 10,505,435 | | |
$ | 6,178,021 | |
See
accompanying notes to unaudited financial statements.
GREENWICH
LIFESCIENCES, INC.
STATEMENTS
OF OPERATIONS
FOR
THE THREE MONTHS ENDED MARCH 31, 2026 AND 2025 (UNAUDITED)
| | |
2026 | | |
2025 | |
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| Revenue | |
$ | — | | |
$ | — | |
| Operating expenses | |
| | | |
| | |
| Research and development | |
| 5,207,564 | | |
| 2,271,148 | |
| General and administrative | |
| 518,190 | | |
| 497,602 | |
| Total operating expenses | |
| 5,725,754 | | |
| 2,768,750 | |
| Loss from operations | |
| (5,725,754 | ) | |
| (2,768,750 | ) |
| Interest income | |
| 68,617 | | |
| 23,970 | |
| Net loss | |
$ | (5,657,137 | ) | |
$ | (2,744,780 | ) |
| Per share information: | |
| | | |
| | |
| Net loss per common share, basic and diluted | |
$ | (0.39 | ) | |
$ | (0.21 | ) |
| Weighted average common shares outstanding, basic and diluted | |
| 14,565,230 | | |
| 13,171,555 | |
See
accompanying notes to unaudited financial statements.
GREENWICH
LIFESCIENCES, INC.
STATEMENTS
OF STOCKHOLDERS’ EQUITY
FOR
THE THREE MONTHS ENDED MARCH 31, 2026 AND 2025 (UNAUDITED)
| | |
| | |
| | |
Additional | | |
| | |
Total | |
| | |
Common Stock | | |
Paid-in | | |
Accumulated | | |
Stockholders’ |
| | |
Shares | | |
Par Amount | | |
Capital | | |
Deficit | | |
Equity | |
| Balances, December 31, 2024 | |
| 13,152,729 | | |
$ | 13,153 | | |
$ | 68,674,261 | | |
$ | (67,778,788 | ) | |
$ | 908,626 | |
| Stock-based compensation | |
| — | | |
| — | | |
| 1,544,214 | | |
| — | | |
| 1,544,214 | |
| Sale of common stock via ATM program, net of costs | |
| 39,918 | | |
| 40 | | |
| 492,383 | | |
| — | | |
| 492,423 | |
| Net loss | |
| — | | |
| — | | |
| — | | |
| (2,744,780 | ) | |
| (2,744,780 | ) |
| Balances, March 31, 2025 | |
| 13,192,647 | | |
$ | 13,193 | | |
$ | 70,710,858 | | |
$ | (70,523,568 | ) | |
$ | 200,483 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| Balances, December 31, 2025 | |
| 14,298,446 | | |
$ | 14,299 | | |
$ | 87,475,924 | | |
$ | (87,137,006 | ) | |
$ | 353,217 | |
| Stock-based compensation | |
| — | | |
| — | | |
| 1,544,214 | | |
| — | | |
| 1,544,214 | |
| Sale of common stock via ATM program, net of costs | |
| 367,547 | | |
| 367 | | |
| 9,029,545
| | |
| — | | |
| 9,029,912
| |
| Net loss | |
| — | | |
| — | | |
| — | | |
| (5,657,137 | ) | |
| (5,657,137 | ) |
| Balances, March 31, 2026 | |
| 14,665,993 | | |
$ | 14,666
| | |
$ | 98,049,683
| | |
$ | (92,794,143 | ) | |
$ | 5,270,206 | |
See
accompanying notes to unaudited financial statements.
GREENWICH
LIFESCIENCES, INC.
STATEMENTS
OF CASH FLOWS
FOR
THE THREE MONTHS ENDED MARCH 31, 2026 AND 2025 (UNAUDITED)
| | |
2026 | | |
2025 | |
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| Operating activities: | |
| | | |
| | |
| Net loss | |
$ | (5,657,137 | ) | |
$ | (2,744,780 | ) |
| Adjustments required to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
| Amortization | |
| — | | |
| 903 | |
| Stock-based compensation | |
| 1,544,214 | | |
| 1,544,214 | |
| Changes in operating assets and liabilities: | |
| | | |
| | |
| Accounts payable | |
| (365,461 | ) | |
| (643,237 | ) |
| Unreimbursed expenses (accrued) | |
| (224,114 | ) | |
| 8,446 | |
| Net cash used in operating activities | |
| (4,702,498 | ) | |
| (1,834,454 | ) |
| Financing activities: | |
| | | |
| | |
| Sale of common stock via ATM program, net of costs | |
| 9,029,912 | | |
| 492,423 | |
| Net cash provided by financing activities | |
| 9,029,912 | | |
| 492,423 | |
| Net increase (decrease) in cash | |
| 4,327,414 | | |
| (1,342,031 | ) |
| Cash, beginning of period | |
| 6,178,021 | | |
| 4,091,990 | |
| Cash, end of period | |
$ | 10,505,435 | | |
$ | 2,749,959 | |
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.
Going Concern
The
Company has prepared its financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy
its liabilities in the normal course of business. However, the Company has incurred net losses since its inception and has negative operating
cash flows. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern within
one year after the date these financial statements are issued. The accompanying
financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of
assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty concerning the Company’s
ability to continue as a going concern.
As
of March 31, 2026, the Company had cash of $10,505,435. For the foreseeable future, the Company’s ability to continue its operations
is dependent upon its ability to obtain additional capital.
3.
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, 2025 and 2024 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 $4,445.
The month-to-month sub-lease is from a related party and the underlying lease expires in July of 2026. Any right of use asset and liability
is deemed to be nominal as of March 31, 2026 and December 31, 2025.
Basic
and Diluted Loss per Share
As
of March 31, 2026 the Company had no common stock equivalents related to warrants outstanding. As of March 31, 2025, the Company had
common stock equivalents related to warrants outstanding to acquire 20,174 shares of the Company’s common stock.
As
of March 31, 2026 and 2025, the Company had common stock equivalents related to options outstanding to acquire 3,226,065 and 3,126,065
shares of the Company’s common stock, respectively.
As
of March 31, 2026 and 2025, the Company has no common stock equivalents related to convertible preferred stock issued and outstanding.
The
following table sets forth the computation of basic and diluted net loss per common share for the periods indicated:
Schedule of Basic and Diluted Net Loss Per Common Share
| | |
2026 | | |
2025 | |
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| Basic and diluted net loss per share calculation: | |
| | | |
| | |
| Net loss, basic | |
| (5,657,137 | ) | |
| (2,744,780 | ) |
| Change in fair value of warrants | |
| — | | |
| — | |
| Net loss, diluted | |
| (5,657,137 | ) | |
| (2,744,780 | ) |
| Weighted average common shares outstanding, basic and diluted | |
| 14,565,230 | | |
| 13,171,555 | |
| Net loss per common share, basic and diluted | |
$ | (0.39 | ) | |
$ | (0.21 | ) |
4.
Related Party Transactions
Unreimbursed
expenses have been accrued and incurred by management, which total $52,382 as of March 31, 2026 and $276,496 as of December 31,
2025.
Two other members of Snehal Patel’s family are contracted or employed by the Company. The total cash compensation
paid to the two family members for the three months ended March 31, 2026 and 2025 were approximately $65,000
and $56,000, respectively. The total option compensation
paid to the two family members for the three months ended March 31, 2026 and 2025 were approximately $66,000
and $66,000, respectively.
The total reimbursements submitted for the three months ended March 31, 2026 and 2025 were approximately $2.2
million and $0.7 million, respectively.
5.
Commitments and Contingencies
Accounts
payable total $4,288,183 and $4,653,644 as of March 31, 2026 and December 31, 2025, respectively.
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 the following obligations to HJF which include accrued interest which totals $220,845 and patent expense reimbursement
which totals $245,966 as of March 31, 2026 and December 31, 2025.
Deferred
Compensation
Bonus
compensation of $367,538 for senior management for services provided in 2025 has been deferred. Bonus compensation of $306,281 for senior
management for services provided in 2024 has been deferred.
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.
6.
Stockholders’ Equity
As
of March 31, 2026, 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 three months ended March 31, 2026 and
2025.
On
January 23, 2022, November 30, 2022, November 17, 2023, March 12, 2024, March 2, 2025, and December 27, 2025, the board of directors
sequentially extended the lock-up of the shares owned by the Company’s directors, officers, and existing pre-IPO investors to September
30, 2026 (approximately 72 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.
After September 30, 2026, leak-out provisions will become effective unless otherwise modified by the board of directors.
Between
January 1, 2026 and March 31, 2026, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement
with H. C. Wainwright, in which it issued and sold a total of 367,547 shares
of its common stock at an average offering price of $25.33 per
share for gross proceeds of $9,309,189 and
net proceeds of $9,029,912,
after deducting underwriting discounts and commissions and offering expenses borne by the Company, which totalled $279,277.
Between
January 1, 2025 and March 31, 2025, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with
H. C. Wainwright, in which it issued and sold a total of 39,918 shares of its common stock at an average offering price of $12.52 per
share for gross proceeds of $499,936 and net proceeds of $492,423, after deducting underwriting discounts and commissions and offering
expenses borne by the Company, which totalled $7,513.
Total
shares outstanding as of May 26, 2026, do not exclude 108,208 shares of common stock which were cancelled on January 10, 2026, due
to breaches of agreements by an existing shareholder.
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%. As of March 31, 2026, $8,977,282 was expensed
and $535,074 may be expensed in the future if and as vesting occurs. As of March 31, 2025, $6,599,194 was expensed. Vesting will be
based on time of service over a four year period.
On
December 24, 2024, prior to the close of the Nasdaq market, 1,627,937 shares of common stock were granted to employees, consultants,
and directors issuable upon exercise of outstanding stock options under the Company’s Amended 2024 Equity Incentive Plan at an
exercise price of $12.16 per share, which was the most recent prior closing share price on December 23, 2024. The options had a fair
value on the grant date of $16,190,565, based on a risk-free rate of 4.5% and an annualized volatility of 103%. As of March 31, 2026,
$9,623,699 was expensed and $6,566,866 may be expensed in the future if and as vesting occurs. As of March 31, 2025, $5,824,931 was
expensed. Vesting will be based on time of service over a three year period.
On
November 13, 2025, after the close of the Nasdaq market, 100,000 shares of common stock were granted and vested to management issuable
upon exercise of outstanding stock options under the Company’s Amended 2024 Equity Incentive Plan at an exercise price of $8.20
per share, which was the closing share price on November 13, 2025. The options had a fair value on the grant date of $626,469, based
on a risk-free rate of 3.7% and an annualized volatility of 101%, of which $626,469 was expensed through December 31, 2025.
7.
Segment Information
Operating
segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief
operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company’s
CODM is the Chief Executive Officer. The Company views its operations and manages its business as one operating segment, which includes
all activities related to its clinical development programs. The determination of a single reportable segment is consistent with the
financial information provided to the CODM. The CODM views and manages the Company’s clinical development programs as a single
reportable segment for which all operations are centralized and does not evaluate any other discrete financial information. The accounting
policies of the Company’s single reportable segment are the same as those for the financial statements.
Segment
loss is measured as the Company’s net loss as reported on the statement of operations, which includes segment expenses such as
research and development and general and administrative expenses and other segment items such as interest expense. As the Company does
not currently generate revenues or profit, the CODM evaluates performance, makes decisions, allocates resources, and plans future activities
through analysis of segment expense information. The CODM also monitors the Company’s cash and cash equivalents and net cash used
in operations as reported on the balance sheet and the statement of cash flows, respectively. The measure of total segment assets is
reported on the balance sheet as total assets.
8.
Subsequent Events
The
Company has evaluated events through the filing date of this Quarterly Report on Form 10-Q, and determined that there have been no subsequent
events that occurred that would require adjustments to our disclosures in the financial statements, other than the following:
Between
April 1, 2026 and April 15, 2026, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with
H. C. Wainwright, in which it issued and sold a total of 12,215 shares of its common stock at an average offering price of $26.22 per
share for gross proceeds of $320,279 and net proceeds of $310,664, after deducting underwriting discounts and commissions and offering
expenses borne by the Company, which totalled $9,615.
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, 2025. 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 our Phase III clinical trial, Flamingo-01, which is evaluating GLSI-100, an
immunotherapy to prevent breast cancer recurrences. 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. We are currently expanding Flamingo-01
into Europe with plans to open up to 150 sites globally. 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 $19.4 million and $17.4
million for the years ended December 31, 2025 and 2024, respectively and $5.7 million and $2.7 million for the three months ended
March 31, 2026 and 2025, 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 March 31, 2026 and 2025
Research
and Development Expenses
Research
and development expenses increased by $2,936,416, or 129%, to $5,207,564 for the three months ended March 31, 2026 from $2,271,148 for
the three months ended March 31, 2025. The increase was primarily the result of an increase in accounts payable for clinical trial expenses.
General
and Administrative Expenses
General
and administrative expenses increased by $20,588, or 4%, to $518,190 for the three months ended March 31, 2026 from $497,602 for the
three months ended March 31, 2025.
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 March 31, 2026 and December 31, 2025, our principal source of liquidity was our cash,
which totalled $10,505,435 and $6,178,021, 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.
Cash
Flow Activities for the Three Months Ended March 31, 2026 and 2025
We
incurred net losses of $5,657,137 and $2,744,780 during the three month periods ended March 31, 2026 and 2025, respectively. The
increase was primarily the result of an increase in accounts payable for clinical
trial expenses.
Operating
Activities
Net
cash used in operating activities was $4,702,498 for the three months ended March 31, 2026 and $1,834,454 for the three months ended
March 31, 2025. The increase was primarily the result of an increase in clinical trial expenses.
Investing
Activities
We
did not use or generate cash from investing activities during the three months ended March 31, 2026 and 2025.
Financing
Activities
Between
January 1, 2026 and March 31, 2026, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement
with H. C. Wainwright, in which it issued and sold a total of 367,547 shares of its common stock at an average offering price of
$25.33 per share for gross proceeds of $9,309,189 and net proceeds of $9,029,912, after deducting underwriting discounts and
commissions and offering expenses borne by the Company, which totalled $279,277.
Between
January 1, 2025 and March 31, 2025, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with
H. C. Wainwright, in which it issued and sold a total of 39,918 shares of its common stock at an average offering price of $12.52 per
share for gross proceeds of $499,936 and net proceeds of $492,423, after deducting underwriting discounts and commissions and offering
expenses borne by the Company, which totalled $7,513.
Between
April 1, 2026 and April 15, 2026, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with
H. C. Wainwright, in which it issued and sold a total of 12,215 shares of its common stock at an average offering price of $26.22 per
share for gross proceeds of $320,279 and net proceeds of $310,664, after deducting underwriting discounts and commissions and offering
expenses borne by the Company, which totalled $9,615.
Contractual
Obligations and Commitments
As
of March 31, 2026, we did not have any material contractual obligations, other than employment and shareholder agreements and the license
for GP2 from HJF.
Off-Balance
Sheet Arrangements
As
of March 31, 2026, 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. There are no critical accounting policies or estimates for the year ended December 31, 2025 and three months ended March 31,
2026.
Recent
Adopted Accounting Pronouncements
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments. The main objective of the standard is to provide financial statement users with more decision-useful information about the
expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date.
To achieve this objective, the amendments in this standard replace the incurred loss impairment methodology in current GAAP with a methodology
that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform
credit loss estimates. The update is effective for the Company beginning January 1, 2023 with early adoption permitted. The Company adopted
the standard on January 1, 2023. The adoption of this standard did not have a material effect on the Company’s audited financial
statements and related disclosures.
In
October 2024, the FASB issued ASU 2024-03, which requires public business entities to provide detailed disclosures of specific expense
categories—such as employee compensation, depreciation, and amortization—within the relevant expense captions on the income
statement (e.g., Cost of Sales, SG&A). The standard is effective for fiscal years beginning after December 15, 2026, and interim
periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the
impact of this guidance on its financial statement disclosures. As this guidance relates to disclosure only, it is not expected to have
a material impact on the Company’s financial position or results of operations.
Recently
Issued Accounting Pronouncements Not Yet Adopted
In
October 2023, the FASB issued ASU 2023-06—Codification Amendments in Response to the SEC’s Disclosure Update and Simplification
Initiative. The main objective of the amendment is to modify the disclosure or presentation requirements of various Topics in the Codification.
Certain amendments represent clarifications to or technical corrections of the current requirements. to eliminate disclosure requirements
that were redundant, duplicative, overlapping, outdated, or superseded. The effective date for each amendment will be when the SEC’s
removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. The Company
is still evaluating the impact of the adoption of this standard.
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,
when available to the Company, 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 March 31, 2026, 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, lack of accounting system for financial reporting/bookkeeping and
software for stock awards, and insufficient policies and procedures for processing and approving employee expense reports. 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, 2025:
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
None.
ITEM
6. EXHIBITS
Exhibit
Number |
|
Description
of Exhibit |
| |
|
|
| 31.1 |
|
Certification of Chief Executive Officer and Principal Financial and Accounting Officer required by Rule 13a-14(a)/15d-14(a) under the Exchange Act. |
| |
|
|
| 32.1 |
|
Certification of Chief Executive Officer and Principal Financial and Accounting 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 |
| |
|
|
| 101.SCH |
|
Inline XBRL Taxonomy Extension Schema |
| |
|
|
| 101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase |
| |
|
|
| 101.LAB |
|
Inline XBRL Taxonomy Extension Labels Linkbase |
| |
|
|
| 101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase |
| |
|
|
| 101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase |
| |
|
|
| 104 |
|
Cover Page Interactive Data File - the cover page from
the Registrant’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 is formatted in Inline XBRL |
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. |
| |
|
|
| June 3, 2026 |
By: |
/s/ Snehal Patel |
| |
|
Snehal Patel |
| |
|
Chief Executive Officer |
| |
|
(Principal Executive Officer and Principal Accounting
and Financial Officer) |