UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended: September 30, 2024
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from __________ to __________
Commission
File Number: 001-42195
OS
THERAPIES INCOPORATED
(Exact
name of registrant as specified in its charter)
Delaware | | 82-5118368 |
(State or other jurisdiction of | | (I.R.S. Employer |
incorporation or organization) | | Identification No.) |
115 Pullman Crossing Road, Suite 103 | | |
Grasonville, Maryland | | 21638 |
(Address of principal executive offices) | | (Zip Code) |
(410)
297-7793
(Registrant’s
telephone number, including area code)
N/A
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
Common Stock, par value $0.001 per share | | OSTX | | NYSE American |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒
No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ | Accelerated filer ☐ |
Non-accelerated filer ☒ | Smaller reporting company ☒ |
| Emerging growth Company ☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The
number of shares of the registrant’s common stock outstanding as of the close of business on November 11, 2024 was 21,238,378.
TABLE
OF CONTENTS
OS
THERAPIES INCORPORATED
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
OS
Therapies Incorporated
Balance Sheets
(unaudited)
| |
September 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
ASSETS | |
| | |
| |
Current Assets | |
| | |
| |
Cash | |
$ | 1,858,104 | | |
$ | 38,982 | |
Deferred Offering Costs | |
| - | | |
| 751,050 | |
Prepaid Expenses | |
| 35,000 | | |
| - | |
Employee Advances | |
| 77,500 | | |
| - | |
Total Current Assets | |
| 1,970,604 | | |
| 790,032 | |
Long Term Assets | |
| | | |
| | |
Fixed Assets (Net) | |
| 6,660 | | |
| 8,050 | |
TOTAL ASSETS | |
$ | 1,977,264 | | |
$ | 798,082 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
Current Liabilities | |
| | | |
| | |
Accounts Payable | |
$ | 1,771,965 | | |
$ | 2,715,399 | |
Accrued Interest on Convertible Notes | |
| - | | |
| 2,026,323 | |
Accrued Expenses | |
| 296,400 | | |
| 162,500 | |
Accrued Payroll and Payroll Taxes – Related Party | |
| 10,145 | | |
| 112,137 | |
Accrued Payroll and Payroll Taxes | |
| 881 | | |
| 33,543 | |
Redemption Premium | |
| - | | |
| 4,580,304 | |
Preferred Dividends Payable | |
| 375,000 | | |
| 343,750 | |
Convertible Notes – A (Net Debt Discount) | |
| - | | |
| 1,051,032 | |
Convertible Notes – A (Related Party Net Debt Discount) | |
| - | | |
| 100,000 | |
Convertible Notes – B (Net Debt Discount) | |
| - | | |
| 5,154,000 | |
Convertible Notes – C (Net Debt Discount) | |
| - | | |
| 3,873,417 | |
Convertible Notes – D (Net Debt Discount) | |
| - | | |
| 1,950,160 | |
Convertible Notes – E (Net Debt Discount) | |
| - | | |
| 1,100,000 | |
Convertible Notes – F (Net Debt Discount) | |
| - | | |
| 1,381,732 | |
Make-whole Stock Liability | |
| 130,000 | | |
| 130,000 | |
Total Current Liabilities | |
| 2,584,391 | | |
| 24,714,297 | |
Long-Term Liabilities | |
| | | |
| | |
TEDCO Grant | |
| 100,000 | | |
| 100,000 | |
Total Long-Term Liabilities | |
| 100,000 | | |
| 100,000 | |
Total Liabilities | |
| 2,684,391 | | |
| 24,814,297 | |
| |
| | | |
| | |
STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
Common Stock, par value $0.001, 50,000,000 shares authorized, 21,180,883 and 5,340,000 issued and outstanding, respectively | |
| 21,181 | | |
| 5,340 | |
Preferred Stock, par value $0.001, 5,000,000 shares authorized, 0 and 1,302,082 shares Preferred Series A issued and outstanding, respectively | |
| - | | |
| 1,302 | |
Additional paid-in capital | |
| 34,712,833 | | |
| 5,495,330 | |
Accumulated deficit | |
| (35,441,141 | ) | |
| (29,518,187 | ) |
Total Stockholders’ Deficit | |
| (707,127 | ) | |
| (24,016,215 | ) |
| |
| | | |
| | |
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
$ | 1,977,264 | | |
$ | 798,082 | |
The
accompanying notes are an integral part of these unaudited financial statements.
OS
Therapies Incorporated
Statements of Operations
(unaudited)
| |
For the three months ended | | |
For the three months ended | | |
For the nine months ended | | |
For the nine months ended | |
| |
September 30, | | |
September 30, | | |
September 30, | | |
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
OPERATING EXPENSES | |
| | |
| | |
| | |
| |
Research & Development | |
$ | 1,210,216 | | |
$ | 454,505 | | |
$ | 1,968,591 | | |
$ | 2,197,936 | |
General & Administrative | |
| 1,227,177 | | |
| 167,703 | | |
| 1,878,831 | | |
| 987,677 | |
Loss from Operations | |
| (2,437,393 | ) | |
| (622,208 | ) | |
| (3,847,422 | ) | |
| (3,185,613 | ) |
| |
| | | |
| | | |
| | | |
| | |
OTHER INCOME/EXPENSE | |
| | | |
| | | |
| | | |
| | |
Interest Income | |
| - | | |
| 1 | | |
| 1 | | |
| 2 | |
Interest Expense | |
| (437,839 | ) | |
| (1,352,783 | ) | |
| (2,044,283 | ) | |
| (3,141,405 | ) |
Total Other Expense | |
| (437,839 | ) | |
| (1,352,782 | ) | |
| (2,044,282 | ) | |
| (3,141,403 | ) |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS | |
| (2,875,232 | ) | |
| (1,974,990 | ) | |
| (5,891,704 | ) | |
| (6,327,016 | ) |
| |
| | | |
| | | |
| | | |
| | |
Cumulative Series A Preferred Stock Dividend Requirement | |
| - | | |
| (31,250 | ) | |
| (31,250 | ) | |
| (93,750 | ) |
NET LOSS available to common shareholders | |
$ | (2,875,232 | ) | |
$ | (2,006,240 | ) | |
$ | (5,922,954 | ) | |
$ | (6,420,766 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic & Diluted Weighted Average Common Shares Outstanding | |
| 15,897,460 | | |
| 5,340,000 | | |
| 9,249,951 | | |
| 10,526,154 | |
Basic & Diluted Loss per Common Share Outstanding | |
$ | (0.18 | ) | |
$ | (0.38 | ) | |
$ | (0.64 | ) | |
$ | (0.61 | ) |
The
accompanying notes are an integral part of these unaudited financial statements.
OS
Therapies Incorporated
Statements
of Stockholders’ Deficit
For
the Three and Nine Months Ended September 30, 2024 and 2023
(unaudited)
| |
Common Stock | | |
| | |
| | |
| | |
| | |
| |
| |
CS – Shares | | |
Preferred Stock | | |
Additional | | |
| | |
Total | |
| |
CS – Par | | |
Shares Par | | |
Paid-in | | |
Accumulated | | |
Stockholders’ | |
| |
Amount | | |
Amount | | |
Capital | | |
Deficit | | |
Deficit | |
Balances, December 31, 2022 | |
| 4,990,000 | | |
| 4,990 | | |
| 1,302,082 | | |
$ | 1,302 | | |
$ | 4,038,083 | | |
$ | (21,601,603 | ) | |
$ | (17,557,228 | ) |
Conversion of Make Whole Liability to Common Stock | |
| 350,000 | | |
| 350 | | |
| - | | |
| - | | |
| 699,650 | | |
| - | | |
| 700,000 | |
Preferred Dividends | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (31,250 | ) | |
| (31,250 | ) |
Net Loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,846,969 | ) | |
| (1,846,969 | ) |
Balances, March 31, 2023 | |
| 5,340,000 | | |
$ | 5,340 | | |
| 1,302,082 | | |
$ | 1,302 | | |
$ | 4,737,733 | | |
$ | (23,479,822 | ) | |
$ | (18,735,447 | ) |
Preferred Dividends | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (31,250 | ) | |
| (31,250 | ) |
Net Loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,505,057 | ) | |
| (2,505,057 | ) |
Balances, June 30, 2023 | |
| 5,340,000 | | |
$ | 5,340 | | |
| 1,302,082 | | |
$ | 1,302 | | |
$ | 4,737,733 | | |
$ | (26,016,129 | ) | |
$ | (21,271,754 | ) |
Preferred Dividends | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (31,250 | ) | |
| (31,250 | ) |
APIC Make Whole Shares | |
| - | | |
| - | | |
| - | | |
| - | | |
| 757,597 | | |
| - | | |
| 757,597 | |
Net Loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,974,990 | ) | |
| (1,974,990 | ) |
Balances, September 30, 2023 | |
| 5,340,000 | | |
$ | 5,340 | | |
| 1,302,082 | | |
$ | 1,302 | | |
$ | 5,495,330 | | |
$ | (28,022,369 | ) | |
$ | (22,520,397 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balances, December 31, 2023 | |
| 5,340,000 | | |
$ | 5,340 | | |
| 1,302,082 | | |
| 1,302 | | |
$ | 5,495,330 | | |
$ | (29,518,187 | ) | |
$ | (24,016,215 | ) |
Conversion of Preferred Stock to Common Stock | |
| 651,041 | | |
| 651 | | |
| (1,302,082 | ) | |
| (1,302 | ) | |
| 651 | | |
| - | | |
| - | |
Preferred Dividends | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (31,250 | ) | |
| (31,250 | ) |
Net Loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,458,992 | ) | |
| (1,458,992 | ) |
Balances, March 31, 2024 | |
| 5,991,041 | | |
$ | 5,991 | | |
| - | | |
$ | - | | |
$ | 5,495,981 | | |
$ | (31,008,429 | ) | |
$ | (25,506,457 | ) |
Net Loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,557,480 | ) | |
| (1,557,480 | ) |
Balances, June 30, 2024 | |
| 5,991,041 | | |
$ | 5,991 | | |
| - | | |
$ | - | | |
$ | 5,495,981 | | |
$ | (32,565,909 | ) | |
$ | (27,063,937 | ) |
Issuance of Common Stock IPO | |
| 1,600,000 | | |
| 1,600 | | |
| - | | |
| - | | |
| 4,473,626 | | |
| - | | |
| 4,475,226 | |
Conversion of Convertible Notes to Common Stock | |
| 13,153,396 | | |
| 13,154 | | |
| - | | |
| - | | |
| 24,743,662 | | |
| - | | |
| 24,756,816 | |
Conversion of Warrants to Common Stock | |
| 116,313 | | |
| 116 | | |
| - | | |
| - | | |
| (116 | ) | |
| - | | |
| - | |
Issuance of Common Stock to Investment Advisor - Settlement | |
| 320,133 | | |
| 320 | | |
| - | | |
| - | | |
| (320 | ) | |
| - | | |
| - | |
Net Loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,875,232 | ) | |
| (2,875,232 | ) |
Balances, September 30, 2024 | |
| 21,180,883 | | |
$ | 21,181 | | |
| - | | |
$ | - | | |
$ | 34,712,833 | | |
$ | (35,441,141 | ) | |
$ | (707,127 | ) |
The
accompanying notes are an integral part of these unaudited financial statements.
OS
Therapies Incorporated
Statements of Cash Flows
For
the Nine Months Ended September 30, 2024 and 2023
(unaudited)
| |
Nine Months | | |
Nine Months | |
| |
September 30, | | |
September 30, | |
| |
2024 | | |
2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |
| | |
| |
Net loss | |
$ | (5,891,704 | ) | |
$ | (6,327,016 | ) |
Depreciation expense | |
| 1,390 | | |
| 4,220 | |
Amortization of Debt Discounts Issuance and Warrants | |
| 1,425,679 | | |
| 2,433,224 | |
Make-whole expense | |
| - | | |
| 116,688 | |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Prepaid Expenses | |
| (35,000 | ) | |
| - | |
Employee Advances | |
| (77,500 | ) | |
| - | |
Accounts Payable | |
| (943,434 | ) | |
| 1,116,328 | |
Accrued Expenses | |
| 133,900 | | |
| (15,000 | ) |
Accrued Interest on Convertible Notes | |
| 613,605 | | |
| 708,179 | |
Accrued Payroll and payroll taxes | |
| (134,654 | ) | |
| (172,430 | ) |
| |
| | | |
| | |
Net cash used in operating activities | |
| (4,907,718 | ) | |
| (2,135,807 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES | |
| | | |
| | |
Fixed Asset Addition | |
| - | | |
| (19 | ) |
Shareholder Loan Repayment | |
| - | | |
| 1,145 | |
Net cash provided by investing activities | |
| - | | |
| 1,126 | |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES | |
| | | |
| | |
Deferred Offering Costs | |
| - | | |
| (108,240 | ) |
Short-Term Borrowings | |
| 250,000 | | |
| - | |
Short-Term Loan Repayments | |
| (250,000 | ) | |
| - | |
Initial Public Offering (Net of Fees) | |
| 5,225,840 | | |
| - | |
Net Proceeds from Conversion of Debt A, B, C, D, E & F | |
| 1,501,000 | | |
| 2,087,500 | |
Net cash provided by financing activities | |
| 6,726,840 | | |
| 1,979,260 | |
| |
| | | |
| | |
Net change in cash | |
| 1,819,122 | | |
| (155,421 | ) |
Cash – beginning of period | |
| 38,982 | | |
| 171,480 | |
Cash – end of period | |
$ | 1,858,104 | | |
$ | 16,059 | |
| |
| | | |
| | |
Cash paid for interest | |
$ | - | | |
$ | - | |
| |
| | | |
| | |
NON-CASH INVESTING AND FINANCING ACTIVITIES | |
| | | |
| | |
Discount on Notes Payable – redemption premium | |
$ | 750,500 | | |
$ | 1,331,250 | |
Dividends Payable | |
| 31,250 | | |
| 93,750 | |
Conversion of Make-whole Liability to Common Stock & APIC | |
| - | | |
| 700,000 | |
Conversion of Preferred Stock to Common Stock | |
| 1,302 | | |
| - | |
Amortization of deferred offering costs | |
| 751,050 | | |
| - | |
Conversion of Convertible Notes into Common Stock | |
| 24,757,252 | | |
| - | |
Conversion of Warrants into Common Stock | |
| 116 | | |
| - | |
Issuance of Common Stock to Investor Advisor - Settlement | |
| 320 | | |
| - | |
Unwind of 4% anti-dilution to Noble | |
| - | | |
| 757,597 | |
Deferred offering costs recorded as accounts payable | |
$ | - | | |
| 197,023 | |
The
accompanying notes are an integral part of these unaudited financial statements.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
1 — ORGANIZATION AND DESCRIPTION OF BUSINESS, LIQUIDITY, AND RISK FACTORS
OS
Therapies Incorporated (“we,” “us,” “our,” the “Company”) is a Delaware corporation
incorporated on June 24, 2019. It is based in Rockville, Maryland. The Company is the successor to an LLC formed in 2018.
The
Company intends to focus on the identification, development, and commercialization of treatments for Osteosarcoma and other related diseases.
As of September 30, 2024, there is one ongoing clinical trial for Osteosarcoma therapy.
Liquidity
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. 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 September 30, 2024, the Company had cash of $1,858,104. For the foreseeable future, the Company’s ability to continue its operations
is dependent upon its ability to obtain additional capital. The Company is currently seeking to raise additional capital through a public
or private financing of equity; although there can be no assurances the Company will be successful in such a campaign.
NOTE
2 — SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The
accompanying financial statements are presented in conformity with accounting principles generally accepted in the United States
of America (“GAAP”) and pursuant to the rules and regulations of US Securities and Exchange Commission (“SEC”).
The accounting and reporting policies of the Company conform to accounting principles generally accepted in the United States of
America, and the Company’s fiscal year end is December 31. These financial statements should be read in conjunction with the
audited financial statements and related disclosures for the year ended December 31, 2023 included in the Company’s Special Financial
Report on Form 10-K for the year then ended.
Use
of Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect
the amounts reported in its financial statements and accompanying notes. On an ongoing basis, management evaluates these estimates and
judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes
to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual
results may differ from management’s estimates.
Cash
Cash
consists primarily of deposits with commercial banks and financial institutions. The Company maintains cash balances at various financial
institutions. Both interest and non-interest bearing accounts with the same insured depository institution are insured by the Federal
Deposit Insurance Corporation (FDIC) for a combined total of $250,000. In the normal course of business, the Company may have deposits
that exceed the FDIC insured limit. The Company believes that it is not subject to unusual credit risk beyond the normal credit risk
associated with commercial banking relationships. As of September 30, 2024 and December 31, 2023, Chase Bank checking account had
$1,672,466 and $88, respectively. As of September 30, 2024 and December 31, 2023, SVB Bank checking account had $185,638 and $38,894,
respectively. The only account in excess of the FDIC limits is the Chase Bank checking account.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
2 — SIGNIFICANT ACCOUNTING POLICIES (cont.)
Fixed
Asset Policy
A
capital asset is defined as a unit of property that has an economic useful life that extends beyond 12 months. Any items costing
below the threshold or not fitting the definition of a capital asset will be expensed in the financial statements. All capital assets
are recorded at historical cost as of the date acquired. Computer assets will be capitalized and Straight-Line depreciated over 5-years
for financial statement purposes.
Impairment
of Long-Lived Assets
The
Company reviews long-lived assets for impairment when events or changes in circumstances indicate the carrying value of the assets may
not be recoverable. Recoverability is measured by comparison of the book values of the assets to future net undiscounted cash flows that
the assets or the asset groups are expected to generate. If such assets are considered to be impaired, the impairment to be recognized
is measured by the amount by which the book value of the assets exceed their fair value, which is measured based on the estimated discounted
future net cash flows arising from the assets or asset groups. No impairment losses on long-lived assets have been recorded for the
nine months ended September 30, 2024 or the year ended December 31, 2023.
Deferred
Offering Costs
Deferred
offering costs consist of capitalized underwriting, legal, accounting and other expenses incurred through the balance sheet date that
are directly related to the Company’s initial public offering and that were charged to stockholders’ equity upon the completion
of the Company’s initial public offering. At September 30, 2024, the Company no capitalized deferred offering costs. At December
31, 2023, the Company had $751,050 in capitalized deferred offering costs. Upon completion of the Company’s initial public offering
on August 2, 2024, the deferred offering costs were charged to stockholders’ equity.
Debt
Discount and Redemption Premium
The
Company evaluated the Notes in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”) and
determined the Notes are considered share-settled debt and should be recorded as a liability. This conclusion was determined based on
the debt providing the holder with a variable number of shares at settlement with an aggregate fair value equal to the debt instrument’s
outstanding principal. The general measurement guidance in ASC 480 requires obligations that can be settled in shares with a fixed
monetary value at settlement (e.g., share-settled debt) to be carried at fair value unless other accounting guidance specifies another
measurement attribute. It has been determined that the appropriate guidance for share-settled debt is ASC 835. As a result, the
Notes will be recorded at the amortized cost.
The
initial fair value of the redemption value relating to the convertible debt instruments are capitalized and amortized over the term of
the related debt using the straight-line method, which approximates the interest method. If a loan is paid in full, any unamortized financing
costs will be removed from the related accounts and charged to operations. Amortization of debt discount is recorded as a component of
interest expense. In accordance with ASU 2015-03, Interest — Imputation of Interest, the unamortized debt discount
is presented in the accompanying balance sheet as a direct deduction from the carrying amount of the related debt.
Research
and Development Costs
Research
and development expenses are charged to operations as incurred. Research and development expenses include, among other things, salaries,
costs of outside collaborators and outside services, and supplies.
Revenue
Recognition
As
of the date of incorporation, the Company adopted ASU 2014-09, Revenue from Contracts with Customers, and all subsequent
amendments to the ASU (collectively, “ASC 606”), which (i) creates a single framework for recognizing revenue from
contracts with customers that fall within its scope and (ii) revises when it is appropriate to recognize a gain (loss) from the
transfer of nonfinancial assets.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
2 — SIGNIFICANT ACCOUNTING POLICIES (cont.)
Stock-Based
Compensation
The
Company, in accordance with ASC 718, employs the use of stock-based compensation. The compensation expense related to stock granted
to employees and non-employees is measured at the grant date based on the estimated fair value of the award and is recognized on a straight-line
basis over the requisite service period. Forfeitures are recognized as a reduction of stock-based compensation expense as they occur.
Stock-based compensation expense for an award with a performance condition is recognized when the achievement of such performance condition
is determined to be probable. If the outcome of such performance condition is not determined to be probable or is not met, no compensation
expense is recognized and any previously recognized compensation expense is reversed.
Short-term
Leases
For short-term leases, 12
months or less, we record rent expense. Our only lease currently meets this exemption and has been expensed. We have not renewed the current
lease due to landlord restrictions; the ownership is renovating the premises. We have temporarily moved our primary office to 115 Pullman
Crossing Road, Suite #103 in Grasonville, Maryland 21638. The space is the primary office of our Chief Financial Officer and is being
provided rent free. In May 2024, we signed a month-to-month lease with JLabs for $750 per month, primarily to have meetings in New York,
New York and to have an office for our employees when visiting.
Income
taxes
The
Company accounts for income taxes using the asset-and-liability method in accordance with ASC 740, Income Taxes (“ASC 740”).
Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial
statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards.
Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which
those temporary differences are expected to be recovered or settled. The effect on the deferred tax assets and liabilities of a change
in tax rate is recognized in the period that includes the enactment date. A valuation allowance is recorded if it is “more likely
than not” that some portion or all of the deferred tax assets will not be realized in future periods.
The
Company follows the guidance in ASC Topic 740-10 in assessing uncertain tax positions. The standard applies to all tax positions
and clarifies the recognition of tax benefits in the financial statements by providing for a two-step approach of recognition and measurement.
The first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination based upon its technical
merits. The second step involves measurement of the amount to be recognized.
Tax
positions that meet the more-likely than-not threshold are measured at the largest amount of tax benefit that is greater than 50% likely
of being realized upon ultimate finalization with the taxing authority. The Company recognizes the impact of an uncertain income tax
position in the financial statements if it believes that the position is more likely than not to be sustained by the relevant taxing
authority.
The
Company will recognize interest and penalties related to tax positions in income tax expense. As of September 30, 2024 and December 31,
2023, the Company had no unrecognized uncertain income tax positions.
Basic
and Diluted Loss per Share
The
Company computes loss per share in accordance with ASC 260, Earnings per Share (“ASC 260”). ASC 260
requires presentation of both basic and diluted earnings per share (“EPS”) on the face of the statements of operations. Basic
EPS is computed by dividing net loss available to common shareholders (numerator) by the weighted average number of common shares outstanding
(denominator) during the period. Diluted EPS gives effect to all diluted potential common shares outstanding during the period using
the treasury stock method and convertible notes payable using the if-converted method. Diluted EPS excludes all dilutive potential shares
if their effect is antidilutive.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
2 — SIGNIFICANT ACCOUNTING POLICIES (cont.)
Below
is a table listing all preferred stock and common stock equivalents
Common Stock Equivalents | |
September 30, 2024 (unaudited) | | |
December 31, 2023 | |
Convertible Debt | |
| — | | |
| 11,034,773 | |
Make-Whole Liability | |
| 32,500 | | |
| 32,500 | |
Warrants | |
| 621,691 | | |
| 604,282 | |
Preferred Stock | |
| — | | |
| 651,041 | |
Total | |
| 654,191 | | |
| 12,322,596 | |
Fair
Value Measurements
The
Company applies ASC 820 Fair Value Measurement (“ASC 820”), which establishes a framework for measuring
fair value and clarifies the definition of fair value within that framework. ASC 820 defines fair value as an exit price, which
is the price that would be received for an asset or paid to transfer a liability in the Company’s principal or most advantageous
market in an orderly transaction between market participants on the measurement date. The fair value hierarchy established in ASC 820
generally requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair
value. Observable inputs reflect the assumptions that market participants would use in pricing the asset or liability and are developed
based on market data obtained from sources independent of the reporting entity. Unobservable inputs reflect the entity’s own assumptions
based on market data and the entity’s judgments about the assumptions that market participants would use in pricing the asset or
liability and are to be developed based on the best information available in the circumstances.
The
carrying value of the Company’s prepaid expenses, accounts payable and accrued expenses are approximate fair value because of the
short-term maturity of these financial instruments. The redemption feature of the debt instruments is recorded at fair value (See Note 3).
The
valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input
that is significant to the fair value measurement. The levels within the valuation hierarchy are described below:
Level
1 — Assets and liabilities with unadjusted, quoted prices listed on active market exchanges. Inputs to the fair value
measurement are observable inputs, such as quoted prices in active markets for identical assets or liabilities.
Level
2 — Inputs to the fair value measurement are determined using prices for recently traded assets and liabilities with
similar underlying terms, as well as direct or indirect observable inputs, such as interest rates and yield curves that are observable
at commonly quoted intervals.
Level
3 — Inputs to the fair value measurement are unobservable inputs, such as estimates, assumptions, and valuation techniques
when little or no market data exists for the assets or liabilities.
Recent
Accounting Pronouncements
The
Company has evaluated all recent accounting pronouncements and believes that none of them will have a material effect on the Company’s
financial position, results of operations, or cash flows.
NOTE
3 — RELATED PARTY TRANSACTIONS
Accrued
Payroll
At
September 30, 2024 and December 31, 2023, the Company had a payroll payable to the CEO of $10,000 and $300,000, respectively, and related
payroll taxes payable of $0 and $7,830, respectively. During the period ended September 30, 2024 and December 31, 2023, the Company made
advances on the payroll payable and the CEO made repayments.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
3 — RELATED PARTY TRANSACTIONS (cont.)
The
following summarizes activity in respect to payroll advances to the CEO:
Balance December 31, 2022 | |
$ | — | |
Advances during 2023 | |
| 316,198 | |
Repayment | |
| (125,000 | ) |
Balance December 31, 2023 | |
$ | 191,198 | |
Advances during 2024 | |
| 188,155 | |
Repayment | |
| (301,853 | ) |
Balance September 30, 2024 | |
$ | 77,500 | |
In
the second and third quarters of 2024, paychecks were issued to Paul Romness, CEO. The paychecks comprised the remaining balance of backpay,
less all 2023 payroll advances. The payroll taxes were paid that were associated with the backpay and regular pay and are fully paid.
The balance of accrued payroll for the CEO on September 30, 2024 represents a board-approved payroll increase that was approved and paid
in October 2024. Any payroll advances shown as employee advances will be repaid by December 31, 2024 from the CEO’s normal paychecks.
Related
Parties — Convertible Debt
Ted
Search and John Ciccio, collectively known as Mill River Partners LLC, are members of the Board and held convertible notes with face
amounts of $0 and $150,000 as of September 30, 2024 and December 31, 2023, respectively. The convertible notes were converted into
common stock upon consummation of the Company’s initial public offering on August 2, 2024.
Related
Party Accounting Fees
The
company has a bill in accounts payable of $23,252 for the period ended September 30, 2024 and $32,102 for the period ended December 31,
2023 to Shore Accountants MD Inc., an outside accounting firm that handles payroll and bookkeeping and is 100% owned by Chris Acevedo,
the CFO.
NOTE
4 — CONVERTIBLE DEBT
Convertible
Debt
The
Convertible Notes are separated into seven groups — A, B, C, D, E, F and BlinkBio — per the table below:
| | | | | | | | | | | | September 30, 2024 | | | December 31, 2023 | |
| | | | | | | | | Conversion | | | Carrying | | | Carrying | |
Group | | Rate | | | Maturity | | Collateral | | Rate | | | Amount | | | Amount | |
A | | | 10 | % | | 10/31/2024 | | None | | | 80% – 87.5 | % | | $ | — | | | $ | 1,151,032 | |
B | | | 6 | % | | 10/31/2024 | | None | | | 80 | % | | $ | — | | | $ | 5,154,000 | |
C | | | 6 | % | | 10/31/2024 | | None | | | 80 | % | | $ | — | | | $ | 3,873,417 | |
D | | | 6 | % | | 10/31/2024 | | None | | | 50 | % | | $ | — | | | $ | 1,950,160 | |
E | | | 6 | % | | 10/31/2024 | | None | | | 50 | % | | $ | — | | | $ | 1,100,000 | |
F | | | 6 | % | | 10/31/2024 | | None | | | 50 | % | | $ | — | | | $ | 1,381,732 | |
Blink Bio | | | 10 | % | | 3/15/2022 | | None | | | 100 | % | | $ | — | | | $ | — | |
The
Convertible Notes were all converted into common stock on August 2, 2024 upon consummation of the Company’s initial public offering.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
4 — CONVERTIBLE DEBT (cont.)
Group
A
Commencing
in July 2018 through November 2021, the Company entered into an unsecured Subordinated Convertible Promissory Note Agreement (the
“Agreements”) with certain lenders (together, the “Holders” or individually, the “Holder”). Interest
on the unpaid principal balance accrues at a rate of 10% per annum, computed on the basis of the actual number of days elapsed and
a year of 365 days. Unless earlier converted into shares of Equity Securities, the principal and accrued interest will be due and
payable by the Company on demand by the Holders at any time after the earlier of (i) the Maturity Date (as defined in each Agreement)
and (ii) the closing of the Next Equity Financing (as defined below). The stated Maturity Date was extended in October 2023, under
the same terms, until October 31, 2024.
The
Notes will automatically convert into the type of Equity Securities issued in the Next Equity Financing upon closing. The number of shares
of such Equity Securities to be issued will be equal to the quotient obtained by dividing the outstanding principal and unpaid accrued
interest due on the Note on the date of conversion of 80 – 87.5% of the price paid per share for Equity Securities by
the investors in the Next Equity Financing. Equity Securities refers to Company’s common stock or preferred stock and Next Equity
Financing refers to the next sale (or series of related sales) by the Company of its equity securities from which the Company receives
gross proceeds of not less than $3,000,000 (including the aggregate amount of debt securities converted into Equity Securities upon conversion
or cancellation of promissory notes) or $5,000,000, depending upon the signed agreement terms.
In
the event that the Company raises aggregate additional cash proceeds of at least $3,000,000 or $5,000,000 through the sale of the Company’s
equity securities, excluding the sales or conversions of Notes under the Agreement, the outstanding principal amount due will automatically,
and without any action on part of the holder, be converted into fully paid and non-assessable units of the Company’s equity stock
sold in such qualified financing at 12.5% of the equity stock conversion price. The Company, at its option, may pay all accrued, but
unpaid, interest and other charges in cash or by the issuance of additional equity stock at a rate of the applicable conversion price.
The
Company evaluated the Notes in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”),
and determined the Notes are considered share-settled debt and should be recorded as a liability. This conclusion was determined based
on the debt providing the holder with a variable number of shares at settlement with an aggregate fair value equal to the debt instrument’s
outstanding principal. The general measurement guidance in ASC 480 requires obligations that can be settled in shares with a fixed
monetary value at settlement (e.g., share-settled debt) to be carried at fair value unless other accounting guidance specifies another
measurement attribute. It has been determined that the appropriate guidance for share-settled debt is ASC 835. As a result, the
Notes were recorded at the amortized cost.
On
August 2, 2024, the Company consummated its initial public offering, and the Convertible Notes, including accrued interest, converted
into shares of the Company’s common stock.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
4 — CONVERTIBLE DEBT (cont.)
The
convertible debt balance at September 30, 2024 and December 31, 2023 is summarized as follows:
| |
As of | | |
As of | |
| |
September 30, | | |
December 31, | |
Debt A | |
2024 | | |
2023 | |
Principal amount outstanding | |
$ | — | | |
$ | 1,154,000 | |
Less: discounts (issuance, redemptions) | |
| — | | |
| (185,224 | ) |
Amortization of discounts | |
| — | | |
| 182,256 | |
Carrying value | |
| — | | |
| 1,151,032 | |
Less Related Party Portion | |
| — | | |
| (100,000 | ) |
Convertible Notes – A | |
$ | — | | |
$ | 1,051,032 | |
Group
B
Commencing
in May 2020, the Company entered into an unsecured Subordinated Convertible Promissory Note Agreement (the “Agreements”)
with certain lenders (together, the “Holders” or individually, the “Holder”), pursuant to which the Company issued
a Subordinated Convertible Promissory Note (individually the “Note” or together the “Notes”) to the Holders,
principally the Investors brought in by an investment bank. Interest on the unpaid principal balance accrues at a rate of 6% per annum,
computed on the basis of the actual number of days elapsed and a year of 365 days. Unless earlier converted into shares of
Equity Securities, the principal and accrued interest will be due and payable by the Company on demand by the Holders at any time after
the earlier of (i) the Maturity Date (as defined in each Agreement) and (ii) the closing of the Next Equity Financing (as defined
below). The stated Maturity Date was extended in October 2023, under the same terms, until October 31, 2024.
The Notes will automatically
convert into the type of Equity Securities issued in the Next Equity Financing upon closing. The number of shares of such Equity Securities
to be issued will be equal to the quotient obtained by dividing the outstanding principal and unpaid accrued interest due on the Note
on the date of conversion of 80% of the price paid per share for Equity Securities by the investors in the Next Equity Financing. Equity
Securities refers to Company’s common stock or preferred stock and Next Equity Financing refers to the next sale (or series of related
sales) by the Company of its equity securities from which the Company receives gross proceeds of not less than $10,000,000 (including
the aggregate amount of debt securities converted into Equity Securities upon conversion or cancellation of promissory notes).
In
the event that the Company raises aggregate additional cash proceeds of at least $10,000,000 through the sale of the Company’s
equity securities, excluding the sales or conversions of Notes under the Agreement, the outstanding principal amount due will automatically,
and without any action on part of the holder, be converted into fully paid and non-assessable units of the Company’s equity stock
sold in such qualified financing at 12.5% of the equity stock conversion price.
The
Company, at its option, may pay all accrued, but unpaid, interest and other charges in cash or by the issuance of additional equity stock
at a rate of the applicable conversion price.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
4 — CONVERTIBLE DEBT (cont.)
The
Company evaluated the Notes in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”),
and determined the Notes are considered share-settled debt and should be recorded as a liability. This conclusion was determined based
on the debt providing the holder with a variable number of shares at settlement with an aggregate fair value equal to the debt instrument’s
outstanding principal. The general measurement guidance in ASC 480 requires obligations that can be settled in shares with a fixed
monetary value at settlement (e.g., share-settled debt) to be carried at fair value unless other accounting guidance specifies another
measurement attribute. It has been determined that the appropriate guidance for share-settled debt is ASC 835. As a result, the
Notes were recorded at the amortized cost.
On
August 2, 2024, the Company consummated its initial public offering, and the Convertible Notes, including accrued interest, converted
into shares of the Company’s common stock.
The
convertible debt balance at September 30, 2024 and December 31, 2023 is summarized as follows:
| |
As of | | |
As of | |
| |
September 30, | | |
December 31, | |
Debt B | |
2024 | | |
2023 | |
Principal amount outstanding | |
$ | — | | |
$ | 5,154,000 | |
Less: discounts (issuance, redemptions, warrants) | |
| — | | |
| (1,818,939 | ) |
Amortization of discounts | |
| — | | |
| 1,818,939 | |
Carrying value | |
$ | — | | |
$ | 5,154,000 | |
Group
C
Commencing
in July 2021, the Company entered into an unsecured Subordinated Convertible Promissory Note Agreement (the “Agreements”)
with certain lenders (together, the “Holders” or individually, the “Holder”), pursuant to which the Company issued
a Subordinated Convertible Promissory Note (individually the “Note” or together the “Notes”) to the Holders,
principally the Investors brought in by an investment bank. Interest on the unpaid principal balance accrues at a rate of 6% per annum,
computed on the basis of the actual number of days elapsed and a year of 365 days. Unless earlier converted into shares of
Equity Securities, the principal and accrued interest will be due and payable by the Company on demand by the Holders at any time after
the earlier of (i) the Maturity Date (as defined in each Agreement) and (ii) the closing of the Next Equity Financing (as defined
below). The stated Maturity Date was extended in October 2023, under the same terms, until October 31, 2024.
The
Notes will automatically convert into the type of Equity Securities issued in the Next Equity Financing upon closing. The number of shares
of such Equity Securities to be issued will be equal to the quotient obtained by dividing the outstanding principal and unpaid accrued
interest due on the Note on the date of conversion of 80% of the price paid per share for Equity Securities by the investors in the Next
Equity Financing. Equity Securities refers to Company’s common stock or preferred stock and Next Equity Financing refers to the
next sale (or series of related sales) by the Company of its equity securities from which the Company receives gross proceeds of not
less than $10,000,000 (including the aggregate amount of debt securities converted into Equity Securities upon conversion or cancellation
of promissory notes).
In
the event that the Company raises aggregate additional cash proceeds of at least $10,000,000 through the sale of the Company’s
equity securities, excluding the sales or conversions of Notes under the Agreement, the outstanding principal amount due will automatically,
and without any action on part of the holder, be converted into fully paid and non-assessable units of the Company’s equity stock
sold in such qualified financing at 12.5% of the equity stock conversion price.
The
Company, at its option, may pay all accrued, but unpaid, interest and other charges in cash or by the issuance of additional equity stock
at a rate of the applicable conversion price.
The
Company evaluated the Notes in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”),
and determined the Notes are considered share-settled debt and should be recorded as a liability. This conclusion was determined based
on the debt providing the holder with a variable number of shares at settlement with an aggregate fair value equal to the debt instrument’s
outstanding principal. The general measurement guidance in ASC 480 requires obligations that can be settled in shares with a fixed
monetary value at settlement (e.g., share-settled debt) to be carried at fair value unless other accounting guidance specifies another
measurement attribute. It has been determined that the appropriate guidance for share-settled debt is ASC 835. As a result, the
Notes were recorded at the amortized cost.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
4 — CONVERTIBLE DEBT (cont.)
On
August 2, 2024, the Company consummated its initial public offering, and the Convertible Notes, including accrued interest, converted
into shares of the Company’s common stock.
The
convertible debt balance at September 30, 2024 and December 31, 2023 is summarized as follows:
| |
As of | | |
As of | |
| |
September 30, | | |
December 31, | |
Debt C | |
2024 | | |
2023 | |
Principal amount outstanding | |
$ | — | | |
$ | 3,945,020 | |
Less: discounts (issuance, redemptions, warrants) | |
| — | | |
| (1,063,223 | ) |
Amortization of discounts | |
| — | | |
| 1,016,620 | |
Carrying value | |
$ | — | | |
$ | 3,873,417 | |
Group
D
Commencing
in November 2022, the Company entered into an unsecured Subordinated Convertible Promissory Note Agreement (the “Agreements”)
with certain lenders (together, the “Holders” or individually, the “Holder”), pursuant to which the Company issued
a Subordinated Convertible Promissory Note (individually the “Note” or together the “Notes”) to the Holders,
principally the Investors brought in by an investment bank. Interest on the unpaid principal balance accrues at a rate of 6% per annum,
computed on the basis of the actual number of days elapsed and a year of 365 days. Unless earlier converted into shares of
Equity Securities, the principal and accrued interest will be due and payable by the Company on demand by the Holders at any time after
the earlier of (i) the Maturity Date (as defined in each Agreement) and (ii) the closing of the Next Equity Financing (as defined
below). The stated Maturity Date was extended in October 2023, under the same terms, until October 31, 2024.
The
Notes will automatically convert into the type of Equity Securities issued in the Next Equity Financing upon closing. The number of shares
of such Equity Securities to be issued will be equal to the quotient obtained by dividing the outstanding principal and unpaid accrued
interest due on the Note on the date of conversion of 50% of the price paid per share for Equity Securities by the investors in the Next
Equity Financing. Equity Securities refers to Company’s common stock or preferred stock and Next Equity Financing refers to the
next sale (or series of related sales) by the Company of its equity securities from which the Company receives gross proceeds of not
less than $10,000,000 (including the aggregate amount of debt securities converted into Equity Securities upon conversion or cancellation
of promissory notes).
In
the event that the Company raises aggregate additional cash proceeds of at least $10,000,000 through the sale of the Company’s
equity securities, excluding the sales or conversions of Notes under the Agreement, the outstanding principal amount due will automatically,
and without any action on part of the holder, be converted into fully paid and non-assessable units of the Company’s equity stock
sold in such qualified financing at 50% of the equity stock conversion price.
In
connection with the Group D Convertible Notes, the Company agreed to issue an additional 400,000 shares of common stock to the Group
D Holders, prorated based on such Holder’s investment amount, as an inducement for their investment in the Group D Convertible
Notes.
The
Company, at its option, may pay all accrued, but unpaid, interest and other charges in cash or by the issuance of additional equity stock
at a rate of the applicable conversion price.
The
Company evaluated the Notes in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”),
and determined the Notes are considered share-settled debt and should be recorded as a liability. This conclusion was determined based
on the debt providing the holder with a variable number of shares at settlement with an aggregate fair value equal to the debt instrument’s
outstanding principal. The general measurement guidance in ASC 480 requires obligations that can be settled in shares with a fixed
monetary value at settlement (e.g., share-settled debt) to be carried at fair value unless other accounting guidance specifies another
measurement attribute. It has been determined that the appropriate guidance for share-settled debt is ASC 835. As a result, the
Notes were recorded at the amortized cost.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
4 — CONVERTIBLE DEBT (cont.)
On
August 2, 2024, the Company consummated its initial public offering, and the Convertible Notes, including accrued interest, converted
into shares of the Company’s common stock.
The
convertible debt balance at September 30, 2024 and December 31, 2023 is summarized as follows:
| |
As of | | |
As of | |
| |
September 30, | | |
December 31, | |
Debt D | |
2024 | | |
2023 | |
Principal amount outstanding | |
$ | — | | |
$ | 2,000,000 | |
Less: discounts (issuance, redemptions, warrants) | |
| — | | |
| (1,864,654 | ) |
Amortization of discounts | |
| — | | |
| 1,814,814 | |
Carrying value | |
$ | — | | |
$ | 1,950,160 | |
Group
E
Commencing
in February 2023, the Company entered into an unsecured Subordinated Convertible Promissory Note Agreement (the “Agreements”)
with certain lenders (together, the “Holders” or individually, the “Holder”), pursuant to which the Company issued
a Subordinated Convertible Promissory Note (individually the “Note” or together the “Notes”) to the Holders,
principally the Investors brought in by an investment bank. Interest on the unpaid principal balance accrues at a rate of 6% per annum,
computed on the basis of the actual number of days elapsed and a year of 365 days. Unless earlier converted into shares of
Equity Securities, the principal and accrued interest will be due and payable by the Company on demand by the Holders at any time after
the earlier of (i) the Maturity Date (as defined in each Agreement) and (ii) the closing of the Next Equity Financing (as defined
below). The stated Maturity Date was extended in October 2023, under the same terms, until October 31, 2024.
The
Notes will automatically convert into the type of Equity Securities issued in the Next Equity Financing upon closing. The number of shares
of such Equity Securities to be issued will be equal to the quotient obtained by dividing the outstanding principal and unpaid accrued
interest due on the Note on the date of conversion of 50% of the price paid per share for Equity Securities by the investors in the Next
Equity Financing. Equity Securities refers to Company’s common stock or preferred stock and Next Equity Financing refers to the
next sale (or series of related sales) by the Company of its equity securities from which the Company receives gross proceeds of not
less than $10,000,000 (including the aggregate amount of debt securities converted into Equity Securities upon conversion or cancellation
of promissory notes).
In
the event that the Company raises aggregate additional cash proceeds of at least $10,000,000 through the sale of the Company’s
equity securities, excluding the sales or conversions of Notes under the Agreement, the outstanding principal amount due will automatically,
and without any action on part of the holder, be converted into fully paid and non-assessable units of the Company’s equity stock
sold in such qualified financing at 50% of the equity stock conversion price. In connection with
the Group E Convertible Notes, the Company agreed to issue an additional 220,000 shares of common stock to the Group E Holders,
prorated based on such Holder’s investment amount, as an inducement for their investment in the Group E Convertible Notes.
The
Company, at its option, may pay all accrued, but unpaid, interest and other charges in cash or by the issuance of additional equity stock
at a rate of the applicable conversion price.
The
Company evaluated the Notes in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”),
and determined the Notes are considered share-settled debt and should be recorded as a liability. This conclusion was determined based
on the debt providing the holder with a variable number of shares at settlement with an aggregate fair value equal to the debt instrument’s
outstanding principal. The general measurement guidance in ASC 480 requires obligations that can be settled in shares with a fixed
monetary value at settlement (e.g., share-settled debt) to be carried at fair value unless other accounting guidance specifies another
measurement attribute. It has been determined that the appropriate guidance for share-settled debt is ASC 835. As a result, the
Notes were recorded at the amortized cost.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
4 — CONVERTIBLE DEBT (cont.)
On
August 2, 2024, the Company consummated its initial public offering, and the Convertible Notes, including accrued interest, converted
into shares of the Company’s common stock.
The
convertible debt balance at September 30, 2024 and December 31, 2023 is summarized as follows:
| |
As of | | |
As of | |
| |
September 30, | | |
December 31, | |
Debt E | |
2024 | | |
2023 | |
Principal amount outstanding | |
$ | — | | |
$ | 1,100,000 | |
Less: discounts (issuance, redemptions, warrants) | |
| — | | |
| (550,000 | ) |
Amortization of discounts | |
| — | | |
| 550,000 | |
Carrying value | |
| — | | |
| 1,100,000 | |
Less related party portion | |
| — | | |
| (50,000 | ) |
Convertible Notes – E | |
$ | — | | |
$ | 1,050,000 | |
Group
F
Commencing
in June 2023, the Company entered into an unsecured Subordinated Convertible Promissory Note Agreement (the “Agreements”)
with certain lenders (together, the “Holders” or individually, the “Holder”), pursuant to which the Company issued
a Subordinated Convertible Promissory Note (individually the “Note” or together the “Notes”) to the Holders,
principally the Investors brought in by an investment bank. Interest on the unpaid principal balance accrues at a rate of 6% per annum,
computed on the basis of the actual number of days elapsed and a year of 365 days. Unless earlier converted into shares of
Equity Securities, the principal and accrued interest will be due and payable by the Company on demand by the Holders at any time after
the earlier of (i) the Maturity Date (as defined in each Agreement) and (ii) the closing of the Next Equity Financing (as defined
below). The stated Maturity Date was extended in October 2023, under the same terms, until October 31, 2024.
The
Notes will automatically convert into the type of Equity Securities issued in the Next Equity Financing upon closing. The number of shares
of such Equity Securities to be issued will be equal to the quotient obtained by dividing the outstanding principal and unpaid accrued
interest due on the Note on the date of conversion of 50% of the price paid per share for Equity Securities by the investors in the Next
Equity Financing. Equity Securities refers to Company’s common stock or preferred stock and Next Equity Financing refers to the
next sale (or series of related sales) by the Company of its equity securities from which the Company receives gross proceeds of not
less than $10,000,000 (including the aggregate amount of debt securities converted into Equity Securities upon conversion or cancellation
of promissory notes).
In
the event that the Company raises aggregate additional cash proceeds of at least $10,000,000 through the sale of the Company’s
equity securities, excluding the sales or conversions of Notes under the Agreement, the outstanding principal amount due will automatically,
and without any action on part of the holder, be converted into fully paid and non-assessable units of the Company’s equity stock
sold in such qualified financing at 50% of the equity stock conversion price. In connection with the Group F Convertible Notes, the Company
agreed to issue an additional 686,700 shares of common stock to the Group F Holders, prorated based on such Holder’s
investment amount, as an inducement for their investment in the Group F Convertible Notes.
The
Company, at its option, may pay all accrued, but unpaid, interest and other charges in cash or by the issuance of additional equity stock
at a rate of the applicable conversion price.
The
Company evaluated the Notes in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”),
and determined the Notes are considered share-settled debt and should be recorded as a liability. This conclusion was determined based
on the debt providing the holder with a variable number of shares at settlement with an aggregate fair value equal to the debt instrument’s
outstanding principal. The general measurement guidance in ASC 480 requires obligations that can be settled in shares with a fixed
monetary value at settlement (e.g., share-settled debt) to be carried at fair value unless other accounting guidance specifies another
measurement attribute. It has been determined that the appropriate guidance for share-settled debt is ASC 835. As a result, the
Notes were recorded at the amortized cost.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
4 — CONVERTIBLE DEBT (cont.)
On
August 2, 2024, the Company consummated its initial public offering, and the Convertible Notes, including accrued interest, converted
into shares of the Company’s common stock.
The
convertible debt balance at September 30, 2024 and December 31, 2023 is summarized as follows:
| |
As of | | |
As of | |
| |
September 30, | | |
December 31, | |
Debt F | |
2024 | | |
2023 | |
Principal amount outstanding | |
$ | — | | |
$ | 1,932,500 | |
Less: discounts (issuance, redemptions, warrants) | |
| — | | |
| (966,250 | ) |
Amortization of discounts | |
| — | | |
| 415,482 | |
Carrying value | |
$ | — | | |
$ | 1,381,732 | |
Redemption
Liability
The
fair value of the redemption liability is calculated under Level 3 of the fair value hierarchy, is determined based upon a Probability-Weighted
of Expected Returns Model (“PWERM”). This PWERM was determined to be the most appropriate method of estimating the value
of possible redemption or conversion outcomes over time, since the Company has not entered into a priced equity round through December
31, 2024. The fair value of the redemption liability is calculated using the initial value of the convertible note less the debt discount
rate of 12.5% in Group A, 20% in Groups B and C, and 50% in Groups D, E and F. The redemption liability is then amortized over the
remaining life of the note, utilizing the interest rates of 10% and 6% respectively for the groups. The life of each note in Group A
is for a set period of 3 years, and is variable in Groups B, C, D, E and F with a range of 12 months to 3 years. The Company
retains the option to negotiate an extended maturity date for Groups B, C, D, E and F.
The
new embedded redemption values were $0 and $1,541,250 for the nine months ended September 30, 2024 and the year ended December 31,
2023, respectively. On August 2, 2024, the Company consummated its initial public offering, and the Convertible Notes, including accrued
interest, converted into shares of the Company’s common stock. The redemption liability was closed to stockholders’ equity
on such date.
The
redemption liability is re-measured at each period end and is summarized as follows:
| |
As of | | |
As of | |
| |
September 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
New Embedded Redemption Value – Group A | |
| — | | |
| 144,250 | |
New Embedded Redemption Value – Group B | |
| — | | |
| 1,130,800 | |
New Embedded Redemption Value – Group C | |
| — | | |
| 789,004 | |
New Embedded Redemption Value – Group D | |
| — | | |
| 1,000,000 | |
New Embedded Redemption Value – Group E | |
| — | | |
| 550,000 | |
New Embedded Redemption Value – Group F | |
| — | | |
| 966,250 | |
Ending Balance | |
$ | — | | |
$ | 4,580,304 | |
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
4 — CONVERTIBLE DEBT (cont.)
Fees
Associated with Convertible Debt Raise
The
fees associated with the convertible debt raise are legal and investment fees associated with the issuance of the convertible notes for
Groups A, B, C, and D. There were no related parties who received these fees. The fees are amortized over the life of the convertible
note utilizing an interest rate of 10% for Group A and 6% for Groups B, C, and D. The debt issuance liability is re-measured at each
period end and is summarized in the table below.
| |
As of | | |
As of | |
| |
September 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Debt Issuance | |
| | |
| |
Group A | |
$ | — | | |
$ | — | |
Group B | |
| — | | |
| — | |
Group C | |
| — | | |
| 9,133 | |
Group D | |
| — | | |
| — | |
Total Net Debt Issuance | |
$ | — | | |
$ | 9,133 | |
Make-whole
liability — Shares due Noble Capital
In
March 2020, the Company signed a new advisory agreement with Noble Capital, in lieu of cash remuneration and the company agreed to issue
4% of the Company’s shares, with an anti-dilution clause. The make-whole liability represents the shares earned for the anti-dilution
of their stock position over 2020 and 2021. The 2021 year-end had the Company owning an aggregate of 233,202 shares valued in the amount
of $408,413, after issuing 200,000 shares in 2020. In 2021, the Company recorded an associated expense to advisory fees of $152,482 to
recognize the share value earned on the anti-dilution compensation in 2021. In 2022, the Company set aside 70,624 shares to satisfy the
anti-dilution clause. In 2022, the Company recorded an associated expense to advisory fees of $282,496 to recognize the share value earned
on the anti-dilution compensation in the 2022.
For
the nine months ended September 30, 2024 and 2023, the Company recorded an additional 0 and 16,672 shares, respectively, with an associated
expense to advisory fees of $0 and $66,688, respectively, on the anti-dilution compensation.
On
July 1, 2023, the make-whole liability for Noble Capital was determined to be contractually nullified. The Company unwound the liability,
and it is reflected in our Statement of Stockholders’ Deficit.
Noble
Capital and the Company settled various investment fees in dispute, as well as the shares of the Company’s common stock related
to the anti-dilution clause that expired in September 2024. Noble Capital was awarded 320,033 shares of common stock and $50,000 in cash.
Make-whole
liability — Shares Officers & Directors
In
January 2023, 350,000 shares of Class A common stock were issued to officers, key employees, key advisors and directors, leaving 20,000
shares in the balance to be issued to Joacim Borg, a director with a value of $80,000.
On
March 1, 2023, the Company hired Alan Musso, former CFO, and, as part of his compensation contract, he was awarded 12,500 shares
of common stock with a value of $4.00 per share, the $50,000 in compensation of which is reflected in the make-whole stock liability.
Alan
resigned on June 30, 2023, and Christopher Acevedo, current CFO, took his position. Mr. Acevedo was awarded the balance of Mr. Musso’s
shares upon the successful initial public offering.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
4 — CONVERTIBLE DEBT (cont.)
The
Company’s make-whole share liability is summarized in the table below as of September 30, 2024.
Name | | Position | | # Shares | | | Value | | | Date Earned |
Alan Musso | | Former CFO | | | 3,125 | | | $ | 12,500 | | | March 1, 2023 |
Christopher Acevedo | | Current CFO | | | 9,375 | | | | 37,500 | | | August 1, 2024 |
Joacim Borg | | Director | | | 20,000 | | | | 80,000 | | | July 1, 2022 |
TOTAL | | | | | 32,500 | | | $ | 130,000 | | | |
The make-whole liability
shares were issued on November 11, 2024 to the officers and directors.
Warrants
for Placement Agent — Noble Capital
In
March 2020, the Company signed a new advisory agreement with Noble Capital, in lieu of cash remuneration it was provided a 10% warrant
fee, in addition to cash remuneration on debt raises from Noble procured investments. The terms of the warrants are five years at
an exercise price that equates to the average price the convertible debt holders paid in each debt raise round.
The
number of warrants earned in 2020 was 248,855 valued at $248,855. The number of warrants earned in 2021 was 213,782, valued at $427,564.
The total warrants earned as of December 31, 2022 was 162,644, valued at $325,288. No warrants were earned in 2023 or the nine months
ended September 30, 2024.
Warrants
earned in 2022, 2021 and 2020 have been accounted for as a discount to the associated convertible debt with the discounts amortized over
the term of the related debt. The Debt Discount Accretion expense in warrants in the nine months ended September 30, 2024 was $49,840
and in the nine months ended September 30, 2023 was $212,285. The total unamortized discount of those warrants was $0 and $49,840 as
of September 30, 2024 and December 31, 2023, respectively.
Warrantholders
from Noble Capital exercised their warrants for an aggregate of 116,313 shares of common stock out of the aggregate 626,004 shares underlying
warrants held by such holders in September 2024. The balance of the shares underlying warrants held by Noble Capital warrantholders is
509,691 shares. The exercise price for the remaining warrants ranges from $1.31 to $2.59 per share.
Warrants
for Underwriter of Initial Public Offering — Brookline Capital Markets
On
August 2, 2024, the Company issued a warrant to Brookline Capital Markets to purchase 112,000 shares of the Company’s common stock,
pursuant to an underwriting agreement entered into between the Company and Brookline. The warrant is exercisable after 180 days following
July 31, 2024, terminates on July 31, 2029, and has an exercise price of $4.40 per share.
Short-Term
Loan
An
investor lent the Company $100,000 on March 7, 2024. The note is a demand note, carrying interest at 8% and was used for working capital
purposes. An investor lent the Company $150,000 on June 28, 2024. The note is a demand note, carrying interest at 8% and was also used
for working capital purposes. The Company repaid these loans, including accrued interest thereon, in August 2024.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
5 — TEDCO GRANT
In
May of 2021, the Company received the first of two tranches from TEDCO’s Rural & Underserved Business Recovery from
Impact of COVID-19 (RUBRIC) Grant in the amount of $50,000. A second tranche of $50,000 was received in October 2021 for a total
reimbursable grant amount of $100,000. The Company is obligated to report on and pay to TEDCO 3% of their quarterly revenues for
a five-year period following the reward date. Income from grants and investments are not considered revenues. Royalties due to TEDCO
are capped at 150% of the amount of the award or $150,000 total. The Company has the option to eliminate the quarterly royalty obligation
by making an advance payment prior to the end of the five-year period, in which case, the Company will receive a 10% reduction of the
royalty cap percentage for each year prior to the expiration of the five-year reimbursement period that the grant is repaid in full.
If the Company ceases to meet eligibility requirements the reimbursement obligation will become due to TEDCO immediately; however, the
discount for meeting the obligation will still apply.
NOTE
6 — COMMITMENTS AND CONTINGENCIES
Employee
Commitments
There
are no employee commitments as the Company operates on an at-will employment basis.
Rental
Agreement
The
Company had a rental agreement with BXP Shady Grove Lot 7 LLC, beginning in April 2023 and ending in December 2023. The payment term
of the license agreement was $1,000 per month. Rent expense for the year ended December 31, 2023 was $12,000. The Company has not renewed
its lease and has a mailing address at 115 Pullman Crossing Road, Suite 103, Grasonville, Maryland 21638. The Company has rented, on
a month-to-month basis, a virtual office at JLabs in New York, New York.
License
Obligation and Manufacturing Agreements Advaxis
The
Company entered into an exclusive license agreement with Advaxis, Inc in September 2018, as amended, pursuant to which it acquired
the right to develop and commercialize Advaxis HER2 Construct, the Company’s product candidate and the use of Advaxis HER2 Construct
patents.
Per
the agreement, all milestone payments are non-creditable and non-refundable and will be due and payable upon the occurrence of the corresponding
milestone event. For clarity, each milestone payment is payable only once. As of December 31, 2020, the Funding Milestone had been
achieved and payment in full was made in January 2021. As of May 2021, the second milestone had been completed and paid. For
the nine months ended September 30, 2024, no payments were made.
The
milestone events and financial terms are as follows:
Milestone | | Amount | |
1. OST has secured funding of at least Two Million Three Hundred Thirty-Seven Thousand Five Hundred US Dollars ($2,337,500), in the aggregate (The Funding Milestone) (paid) | | | License Commencement Payment $1,550,000 | |
2. The earlier to occur of: (A) OST having secured at least Eight Million US Dollars, in the aggregate or (B) Completion of the first Clinical Trial (with “Completion” meaning that the final patient has enrolled in first Clinical Trial) (paid) | | $ | 1,375,000 | |
3. The earlier to occur of: (A) receipt of Regulatory Approval from the FDA for the First Indication of the first Licensed Product or (B) Initiation of the first Registrational Trial of the first Licensed Product in the Field | | $ | 5,000,000 | |
4. Cumulative Net Sales of all Licensed Products in excess of Twenty Million US Dollars ($20,000,000) | | $ | 1,500,000 | |
5. Cumulative Net Sales of all Licensed Products in excess of Fifty Million US Dollars ($50,000,000) Cumulative Net Sales of all Licensed Products in ex | | $ | 5,000,000 | |
6. Cumulative Net Sales of all Licensed Products in excess of One Hundred Million US Dollars ($100,000,000) | | $ | 10,000,000 | |
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
6 — COMMITMENTS AND CONTINGENCIES (cont.)
All
milestone payments are non-creditable and non-refundable and will be due and payable upon the occurrence of the corresponding date or
milestone, regardless of any failure by the Company to provide the notice required by Section 6.4a of the licensing agreement. For
clarity, each milestone payment is payable only once. As of December 31, 2020, the first milestone had been achieved. As of January 7,
2021, the license commencement payment was paid in full. As of May 21, 2021, the second milestone had been completed and paid in
full.
Additionally,
on an aggregate basis across all licensed products during the royalty term, the Company will pay quarterly to Advaxis royalties on net
sales of licensed products, royalty rates range from a percentage in the high single digits to low double digits. No royalties were payable
in the nine months ended September 30, 2024.
BlinkBio
In
July 2020, the Company entered into a Licensing Agreement with BlinkBio, Inc., to utilize their proprietary technology. As of August 2020,
the $300,000 License fee was fully paid and recorded in license expense. These payments have been recorded in the Licensing expenses
of the accompanying statement of operations. No payments were due or made in 2024. A payment schedule is set for future milestones, is
summarized below:
Milestone Bearing Event | | Milestone
Payment | |
1. | | License Fee to utilize proprietary technology (paid) | | | $300,000 + $2.4 million Convertible Note | |
2. | | Commencement of a toxicology study commented pursuant to Good Laboratory Practices (per 21 CFR Part 58) such that any resulting positive data would be admissible to applicable Regulatory Authorities to support an IND (commonly referred to as “GLP-Tox”) | | $ | 375,000 | |
3. | | Completion of a Phase I Clinical Trial | | $ | 1,500,000 | |
4. | | Completion of a Phase II Clinical Trial | | $ | 2,500,000 | |
5. | | Filing of an NDA, BLA or MAA registration (or the equivalent in any other territory around the world) | | $ | 6,000,000 | |
6. | | Regulatory Approval in the first of the United States, within the EU or within the UK | | $ | 12,000,000 | |
The
Company will make the cash payments set forth in the table above by wire transfer of immediately available funds, to BlinkBio within
thirty (30) days of the occurrence of each milestone set forth with respect to the first Product to attain each such milestone,
except that the first Milestone above will apply with respect to The Company’s first product candidate. During the Royalty Term,
the Company will pay BlinkBio a royalty of six percent (6%) on Net Sales on a Product-by-Product and country-by-country basis during
the Royalty Term, in a country in which no Valid Claim Covers the manufacture, use, or sale of a Product, the royalty on Net Sales of
such Product in such country will be reduced to three percent (3%). No royalties were due in the nine months ended September 30, 2024;
no payments were made in the year 2023.
For
the avoidance of doubt, each Milestone payment will be payable only once, and the aggregate amount of Milestone payments payable hereunder
will not exceed $22,375,000. A Milestone may be achieved by the Company or a Commercial Sublicensee.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE
6 — COMMITMENTS AND CONTINGENCIES (cont.)
George
Clinical Inc.
In
June 2020, the Company entered into a Research Service Agreement, as amended, with George Clinical Inc., to use their clinical research
services for the Company’s study: “An Open Label, Phase 2 Study of Maintenance Therapy with OST-HER2 after Resection
of Recurrent Osteosarcoma”. Under the terms of the agreement, the Company is required to pay to George Clinical certain fees
described in the fee schedule below. The total budget under the agreement is approximately $2,436,928. For the nine months ended September 30,
2024 and year ended December 31, 2023, we paid $345,836 and $921,300, respectively, to George Clinical. These payments have
been recorded as research and development expenses in our Statement of Operations and Comprehensive Loss. The fee schedule for certain
fees and corresponding payment amounts is set forth below.:
George Clinical Payment Schedule | | Payment
Amount | |
1. | | Service Fee Advance (paid) | | $ | 49,989 | |
2. | | Service Fee Advance of $212,335 minus the amount already paid, plus PTC Fee Advance of $31,325 (paid) | | $ | 193,671 | |
3. | | Statistics Fees – 35% on Electronic Data Capture (EDC) Go Live Date | | $ | 47,740 | |
4. | | Statistics Fees – 35% on Development of SAP tables | | $ | 47,740 | |
5. | | Statistics Fees – 30% on Final Analysis | | $ | 40,920 | |
6. | | Service Fees – Remainder Due | | | Split monthly over course of study | |
George
Clinical will track and invoice the Company for the number of task units completed and pass through costs will be invoiced each month
in arrears based on actual costs without mark-up. The PTC Advance Fee will be used to offset final pass through fees payable. As of September
30, 2024, the balance due to George Clinical was $295,082.
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 the Company’s results of operations or financial position.
NOTE
7 — EQUITY
Common
Stock
In
2021, the Company split Common Stock into two classes with fifty million shares of Class A Common Stock, $0.001 par value per share
(“Class A Common Stock”) designated and twenty million shares of Class B Common Stock, $0.001 par value per share
(“Class B Common Stock”). On February 9, 2024, the Company changed the name of the Class A Common Stock and Class B
Common Stock to combine into the name Common Stock, with 50,000,000 shares authorized. As of September 30, 2024 and December 31, 2023,
the Company had 21,180,883 and 5,340,000 shares of Common Stock outstanding, respectively. Common Stock has voting rights.
OS
Therapies Incorporated
Notes to the Financial Statements
For the Nine Months Ended September 30, 2024 and 2023
(unaudited)
NOTE 7 — EQUITY (cont.)
On
August 2, 2024, the Company consummated its initial public offering and sold 1.6 million shares of Common Stock at a price of $4.00 per
share. Concurrent with this consummation, all outstanding Convertible Notes, including accrued interest thereon, automatically converted
into approximately 13.2 million shares of Common Stock, at conversion prices ranging from $0.39 per share to $2.59 per share, after share
discounts ranging from 50% to 87.5% and valuation ceilings ranging from $5 million to $50 million, as applicable.
Preferred
Stock
In
2021, 5,000,000 shares of Preferred Stock were authorized, 1,400,000 were designated as Series A Preferred Stock, with 1,302,082
shares issued of Series A Preferred Stock. Series A Preferred Stock has 5% cumulative coupon and liquidation priority above
all Common Shares. The coupon dividends are computed at 5% of the principal per annum and are recorded monthly.
On
February 9, 2024, the Series A Preferred Stock outstanding was converted to Common Stock on a one common share for every two preferred
shares basis upon the filing of the Company’s third amended and restate certificate of incorporation. Effective February 9,
2024, the company had five million shares of authorized Preferred Stock, none of which were outstanding.
The
dividend due for the nine months ended September 30, 2024 and for the year ended December 31, 2023 was $31,250 and $125,000, respectively,
for a total accrued dividend payable at September 30, 2024 of $375,000
The
Preferred Stock has the following rights and privileges:
Voting — Votes
together with the Common Stock on all matters on an as-converted basis. Approval of a majority of the New Preferred Stock voting
as a separate class will be required to, among other things: (i) adversely change rights of the New Preferred Stock, (ii) change
the authorized number of shares of New Preferred Stock.
Conversion — Each
share of New Preferred Stock is convertible into one share of Common Stock (subject to proportional adjustments for stock splits, stock
dividends and the like) at any time at the option of the holder. Conversion ratio will be subject to adjustment on a broad-based, weighted
average basis in the event of subsequent issuances at a price less than the original issue price (as adjusted) subject to customary exceptions.
The conversion into Common Stock occurred on February 9, 2024.
Liquidation — One
times the original issue price of the New Preferred Stock plus declared but unpaid dividends on each share of New Preferred Stock (or,
if greater, the amount that the New Preferred Stock would receive on an as-converted basis) will be paid first on each share of New Preferred
Stock, and the balance of proceeds to be paid to Common Stock. A merger, reorganization, or similar transaction (including a sale, exclusive
license or other disposition of all or substantially all of the assets of the Company or its subsidiaries) will be treated as a liquidation,
thereby triggering payment of the liquidation preference described above. For the avoidance of doubt, the liquidation preference is intended
to provide the Investor (and its permitted assigns) with an aggregate liquidation payment of $2,500,000.
|
|
Total, as of |
|
|
Total, as of |
|
|
|
September 30,
2024 |
|
|
December 31, 2023 |
|
Shares Issued to Investors |
|
|
— |
|
|
|
1,302,082 |
|
Total Shares Issued |
|
|
— |
|
|
|
1,302,082 |
|
NOTE
8 — SUBSEQUENT EVENTS
| 1. | On October 31, 2024, the Company entered into an Equity Purchase Agreement (the “Equity Purchase Agreement”) with Square Gate Capital Master Fund, LLC-Series 3 (the “Investor”), pursuant to which the Company will have the right, but not the obligation, to sell to the Investor, and the Investor will have the obligation to purchase from the Company, up to $15,000,000 (the “Maximum Commitment Amount”) worth of shares of Common Stock, at the Company’s sole discretion, over the next 24 months, subject to certain conditions precedent and other limitations set forth in the Equity Purchase Agreement. Concurrently with the execution of the Equity Purchase Agreement, the Company also agreed to issue to the Investor, as part of the consideration, shares of the Company’s common stock worth a total of 3% of the Maximum Commitment Amount (the “Initial Commitment Shares”). The ultimate calculation of the per share price of the Initial Commitment Shares will occur on the date immediately prior to a registration statement on Form S-1 covering the resale of the shares to be issued pursuant to the Equity Purchase Agreement. |
| | |
| 2. | On November 11 2024, an aggregate of 32,500 shares of common stock, constituting make-whole liability shares, were issued to certain of the Company’s officers and directors. See Note 4 for more information. |
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis of the financial condition and results of operations of OS Therapies Incorporated (“OS Therapies,”
the “Company,” “we,” “our” or “us”) should be read in conjunction with the financial
statements and notes thereto appearing in Part I, Item 1 of this report. In the following discussions, most percentages and dollar amounts
have been rounded to aid presentation, and, accordingly, all amounts are approximations.
Cautionary
Note Regarding Forward-Looking Statements
This
report contains “forward-looking statements” (within the meaning of Section 27A of the Securities Act of 1933, as amended
(the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)),
which may include information concerning our beliefs, plans, objectives, goals, expectations, strategies, anticipations, assumptions,
estimates, intentions, future events, future revenues or performance, capital expenditures and other information that is not historical
information. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may be beyond our control,
and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements
expressed or implied by such forward-looking statements. When used in this report, the words “seek,” “estimate,”
“expect,” “anticipate,” “project,” “plan,” “contemplate,” “plan,”
“continue,” “intend,” “believe” and variations of such words or similar expressions are intended
to identify forward-looking statements. All forward-looking statements are based upon our current expectations and various assumptions.
We believe there is a reasonable basis for its expectations and beliefs, but there can be no assurance that we will realize its expectations
or that its beliefs will prove to be correct.
There
are a number of risks and uncertainties that could cause our actual results to differ materially from the forward-looking statements
contained in this report. Examples of risks and uncertainties that could cause actual results to differ materially from historical performance
and any forward-looking statements include, but are not limited to, the risks described under the section below titled “Risk Factors”
of our Registration Statements on Form S-1 initially filed with the Securities and Exchange Commission (the “SEC”) on May
30, 2024 and November 12, 2024, as well as any subsequent filings with the SEC.
There
may be other factors of which we are currently unaware or which it currently deems immaterial that may cause its actual results to differ
materially from the forward-looking statements. All forward-looking statements attributable to us or persons acting on our behalf apply
only as of the date they are made and are expressly qualified in their entirety by the cautionary statements included in this report.
Except as may be required by law, we undertake no obligation to publicly update or revise any forward-looking statement to reflect events
or circumstances occurring after the date they were made or to reflect the occurrence of unanticipated events, or otherwise.
We
make available through its Internet website, free of charge, its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K, and amendments to such reports and other filings made by us with the SEC, as soon as practicable after we electronically
file such reports and filings with the SEC. Our website address is www.ostherapies.com. The information contained on our website is not
incorporated by reference into this report.
Overview
We
are a clinical stage biopharmaceutical company focused on the identification, development and commercialization of treatments for Osteosarcoma
(OS) and other solid tumors. Our mission is to address the significant need for new treatments in cancers of the bone in children and
young adults. Osteosarcoma is an extremely challenging and often aggressive cancer that has particular treatment challenges due to its
location, changing genotypes and high metastases rates. We are currently seeking to answer the call for new treatments that will prevent
metastasis and the recurrence of metastases with our lead core product candidate OST-HER2 (also known as OST31-164), a cancer immunotherapy
product candidate that produces a cellular immune response against the cancer antigen HER2. In 2021, we opened a clinical study to produce
data for the U.S. Food and Drug Administration (FDA) to evaluate the safety and efficacy of OST-HER2 in patients after resection
of recurrent Osteosarcoma, which achieved full enrollment of 41 patients in October 2023. We expect topline results from all 41
patients enrolled in the fourth quarter of 2024 and, if successful, intend to seek regulatory approval for OST-HER2 for the prevention
of metastases in Osteosarcoma in 2025. Upon success in gaining regulatory approval from the FDA with OST-HER2 in Osteosarcoma, we intend
to evaluate OST-HER2’s potential use, both alone and in combination with HER2 targeting antibodies such as Herceptin®, in other
solid tumors including breast, esophageal and lung cancers. OST-HER2 has potential uses in both the prevention of metastases in solid
tumors, and therapeutically against HER2-expressing solid tumors treated with HER targeting antibodies.
We
also own rights to OST-Tunable Drug Conjugate (OST-tADC) platform, a next generation antibody-drug conjugate (ADC) silicone dioxide linker
technology. “Tunable” is a term used in drug development that refers to the properties that can be influenced by chemical
modifications, and “antibody-drug conjugate” or ADC is a term used to describe a drug made up of a monoclonal antibody attached
to a cytotoxic payload, or a highly active and toxic pharmaceutical molecule, through chemical linkers. The ADC links an antibody that
can home in on a targeted tumor to deploy the cytotoxic payload or toxic agent against the tumor. Furthering our founding mission, we
intend to investigate clinical indications for OST-tADC in Osteosarcoma and other solid tumors
No
new treatments have been approved by the FDA for human Osteosarcoma for more than 40 years. In humans, Osteosarcoma is an extremely
rare cancer that primarily affects children, teenagers and young adults generally under 40 years of age. We are not aware of any
competing adjuvant therapy for Osteosarcoma to be tested in children that is further along in the development process than OST-HER2.
This disease is difficult to diagnose. The standard of care following first line therapies is simply to screen and wait for possible
recurrence/metastasis, or the development of secondary malignant growths at a distance from a primary site of cancer. Studies published
in the Journal of Clinical Oncology, “Osteosarcoma Relapse After Combined Modality Therapy: An Analysis of Unselected Patients
in the Cooperative Osteosarcoma Study Group (COSS),” by Kempf-Bielack B., et al. (January 2005), and “Second and Subsequent
Recurrences of Osteosarcoma: Presentation, Treatment, and Outcomes of 249 Consecutive Cooperative Osteosarcoma Study Group Patients,”
by Bielack S., et al. (February 2009), reported that recurrence/metastasis happens in approximately half of all patients within 12
to 18 months following initial remittance. For those patients that experience recurrence, metastasis is typically to the lungs and
brain, with survival rates of approximately 13% over the next year, according to these studies.
Critical
Accounting Policies and Significant Judgments and Estimates
Our
financial statements are prepared in accordance with generally accepted accounting principles in the United States (“GAAP”).
The preparation of our financial statements and related disclosures requires us to make estimates and judgments that affect the reported
amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements.
We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under
the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that
are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ
from these estimates under different assumptions or conditions.
Critical
accounting policies are those that, in management’s view, are most important to the portrayal of a company’s financial condition
and results of operations and most demanding on their calls on judgment, often as a result of the need to make estimates about the effect
of matters that are inherently uncertain and may change in subsequent periods. While our significant accounting policies are described
in more detail in Note 2 to our financial statements appearing elsewhere in this report, we believe that the following accounting
policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Debt
Discount and Redemption Premium
We
evaluated the Group A Convertible Notes, the Group B Convertible Notes, the Group C Convertible Notes and the Bridge Notes (collectively,
the “Convertible Notes”) in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”)
and determined that the Convertible Notes are considered share-settled debt and should be recorded as a liability. This conclusion was
determined based on the debt providing the holder with a variable number of shares at settlement with an aggregate fair value equal to
the debt instrument’s outstanding principal. The general measurement guidance in ASC 480 requires obligations that can be
settled in shares with a fixed monetary value at settlement (e.g., share-settled debt) to be carried at fair value unless other accounting
guidance specifies another measurement attribute. It has been determined that the appropriate guidance for share-settled debt is ASC 835.
As a result, the Convertible Notes will be recorded at the amortized cost.
The
initial fair value of the redemption value relating to the convertible debt instruments are capitalized and amortized over the term of
the related debt using the straight-line method, which approximates the interest method. If a loan is paid in full, any unamortized financing
costs will be removed from the related accounts and charged to operations. Amortization of debt discount is recorded as a component of
interest expense. In accordance with ASU 2015-03, Interest — Imputation of Interest, the unamortized debt discount
is presented in the accompanying balance sheet as a direct deduction from the carrying amount of the related debt.
The fair value of the redemption
liability is calculated under Level 3 of the fair value hierarchy and is determined based upon a Probability-Weighted of Expected Returns
Model (“PWERM”). This PWERM was determined to be the most appropriate method of estimating the value of possible redemption
or conversion outcomes over time. The fair value of the redemption liability is calculated using the initial value of the Convertible
Notes less the debt discount rate of 12.5% in Group A, 20% in Groups B and C, and 50% in Groups D, E and F. The redemption liability is
then amortized over the remaining life of the note, utilizing the interest rates of 10% and 6% for the groups, respectively. The life
of each note in Group A is for a set period of three years and is variable in Groups B, C, D, E and F, with a range of 12 months to three
years. We retain the option to negotiate an extended maturity date for Groups B, C, D, E and F. The new embedded redemption values were
$0 and $1,541,250 for the periods ended September 30, 2024 and December 31, 2023, respectively.
The
fees associated with the convertible debt raise are legal and investment fees associated with the issuance of the Convertible Notes for
Groups A, B, C, D, E and F. There were no related parties who received these fees. The fees are amortized over the life of the Convertible
Notes utilizing an interest rate of 10% for Group A and 6% for Groups B, C, D, E and F.
Our
convertible debt raises and all associated accounts were closed out to stockholders’ equity on August 2, 2024, which was the date
on which we consummated our initial public offering and all outstanding convertible notes automatically converted into shares of common
stock.
Components
of Our Results of Operations
Revenue.
We did not recognize revenues for the nine months ended September 30, 2024 or the year ended December 31, 2023.
Operating
Expenses. Our operating expenses are comprised primarily of research and development expenses, general and administrative expenses
and licensing costs.
Research
and Development Expenses. Research and development expenses consist primarily of costs incurred for our research activities,
including our drug discovery efforts, and the development of our product candidates, which include:
|
● |
personnel-related
costs, including salaries, benefits and stock-based compensation expense, for employees engaged in research and development functions; |
|
● |
expenses
incurred in connection with our research programs, including under agreements with third parties, such as consultants and contractors
and CROs; |
|
● |
the
cost of developing and scaling our manufacturing process and manufacturing drug substance and drug product for use in our research
and preclinical and clinical studies, including under agreements with third parties, such as consultants and contractors and contract
development and manufacturing organizations (CDMOs); and |
|
● |
the
cost of laboratory supplies and research materials. |
We
track our direct external research and development expenses on a program-by-program basis. These consist of costs that include fees,
reimbursed materials, and other costs paid to consultants, contractors, CDMOs, and CROs in connection with our preclinical, clinical
and manufacturing activities. We do not allocate employee costs, costs associated with our discovery efforts, and facilities expenses,
including depreciation or other indirect costs, to specific product development programs because these costs are deployed across multiple
programs and, as such, are not separately classified.
We
expect that our research and development expenses will increase substantially as we advance OST-HER2 and OST-tADC into clinical development
and expand our discovery, research and preclinical activities in the near term and in the future.
General
and Administrative Expenses. General and administrative expenses consist primarily of salaries and related costs, including stock-based
compensation, for personnel in executive, finance and administrative functions. General and administrative expenses also include professional
fees for legal, patent, consulting, investor and public relations and accounting and audit services.
We
anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued
research activities and development of our product candidates. We also anticipate that we will incur increased accounting, audit, legal,
regulatory, compliance, and director and officer insurance costs as well as investor and public relations expenses associated with operating
as a public company.
Licensing
Costs. Costs incurred in obtaining technology licenses and asset purchases are charged to licensing costs if the technology licensed
has not reached technological feasibility which includes manufacturing, clinical, intellectual property and/or regulatory success which
has no alternative future use. The licenses purchased by us require substantial completion of research and development and regulatory
and marketing approval efforts in order to reach technological feasibility.
Interest
Expense. We evaluated the Convertible Notes in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”),
and determined the Convertible Notes are considered share-settled debt and should be recorded as a liability. This conclusion was determined
based on the debt providing the holder with a variable number of shares at settlement with an aggregate fair value equal to the debt
instrument’s outstanding principal. The general measurement guidance in ASC 480 requires obligations that can be settled in
shares with a fixed monetary value at settlement (e.g., share-settled debt) to be carried at fair value unless other accounting guidance
specifies another measurement attribute. It has been determined that the appropriate guidance for share-settled debt is ASC 835.
As a result, the Convertible Notes were recorded at the amortized cost.
Cumulative Series A
Preferred Stock Dividend. The Series A preferred stock dividend requirement represents the coupon dividends on our preferred
stock and is identified as a separate component of our statement of operations to compute net income (loss) available to common shareholders.
The coupon dividends are computed at 5% of the principal per annum and are recorded monthly. The cumulative accrued dividend at September
30, 2024 and 2023 was $375,000 and $312,500, respectively. The Series A preferred stock was converted into common stock on a 1:1 basis
in February 2024, and the last coupon dividend was issued in the quarter ended March 31, 2024.
Income
Taxes. Since our inception, we have not recorded income tax benefits for the net operating losses incurred or the research and
development tax credits generated in each year, due to the uncertainty of realizing a benefit from those items.
As
of December 31, 2023, we had U.S. federal net operating loss carry forwards of approximately $16.3 million, which may be available
to offset future taxable income. The federal net operating loss carry forward indefinitely but may only be used to offset 80% of annual
taxable income. As of December 31, 2023, we also had federal and state general business tax credit carry forwards of $1.4 million
available to offset future tax liabilities and expire at various dates beginning in January 1, 2022. We have R&D credits that
we opted to convert and use toward payroll taxes in amounts equal to $0.3 million as of December 31, 2023. As of December 31, 2023,
we also had a federal and state research and development tax credit carry forwards of approximately $0.3 million, which may be available
to offset future tax liabilities and expire at various dates beginning January 1, 2024 and January 1, 2023, respectively.
Deferred
Offering Costs. Deferred offering costs consisted of legal, accounting, printing and filing fees that we capitalized, which will
be offset against the gross proceeds from our initial public offering.
Results
of Operations
Three Months Ended September 30, 2024 Compared
to Three Months Ended September 30, 2023
The following table summarizes
our results of operations for the three months ended September 30, 2024 and 2023:
| |
September 30, | |
(In thousands) | |
2024 | | |
2023 | |
Expenses: | |
| | |
| |
Research and development expenses | |
$ | 1,210,216 | | |
$ | 454,505 | |
General and administrative | |
| 1,227,177 | | |
| 167,703 | |
Total operating expenses | |
| 2,437,393 | | |
| 622,208 | |
| |
| | | |
| | |
Loss from operations | |
| (2,437,393 | ) | |
| (622,208 | ) |
| |
| | | |
| | |
Other income (expenses): Interest Income | |
| - | | |
| 1 | |
Interest expense | |
| (437,839 | ) | |
| (1,352,783 | ) |
Total other expenses | |
| (2,875,232 | ) | |
| (1,974,990 | ) |
| |
| | | |
| | |
Net loss | |
| (2,875,232 | ) | |
| (1,974,990 | ) |
Cumulative Series A preferred stock dividend requirement | |
| - | | |
| (31,250 | ) |
Net loss available to common shareholders | |
$ | (2,875,232 | ) | |
$ | (2,006,240 | ) |
Research and Development
Expenses. Research and development expenses were approximately $1.2 million for the three months ended September 30, 2024
compared to approximately $0.5 million for the three months ended September 30, 2023. This decrease was primarily due to a decrease
in vendor expenses associated with our Phase IIb clinical trial and a decrease in vendor expenses associated with out OST-tADC platform
technology. The following table summarizes our research and development expenses for the three months ended September 30, 2024 and
2023:
| |
As of September 30, | |
(In thousands) | |
2024 | | |
2023 | |
Direct research and development expenses by program: | |
| | |
| |
OST-HER2 | |
$ | 1,007 | | |
$ | 339 | |
OST-tADC | |
| - | | |
| 15 | |
| |
| | | |
| | |
Unallocated research and development expenses: | |
| | | |
| | |
Personnel-related | |
| 203 | | |
| 101 | |
Total research and development expenses | |
$ | 1,210 | | |
$ | 455 | |
For the three months ended
September 30, 2024 and 2023, the direct research and development expenses related to OST-HER2 were primarily lab fees, vendor expenses
and staff payroll fees. In 2024, such expenses were primarily lab fees and related clinical support of approximately $1.0 million attributed
to our Phase IIb clinical trial preparation and CRO costs as we completed IND-enabling studies. OST-tADC related direct research and development
expenses were approximately $0.0 million and $0.0 million for the three months ended September 30, 2024 and 2023, respectively.
General and Administrative
Expenses. General and administrative expenses for the three months ended September 30, 2024 were approximately $1.2 million
compared to $0.2 million for the three months ended September 30, 2023. These expenses were primarily attributed to marketing costs
and accounting fees to consultants.
Licensing Costs. We
did not have any licensing costs for the three months ended September 30, 2024 and 2023.
Interest Expense. Interest
expense for the three months ended September 30, 2024 was approximately $0.4 million compared to $1.4 million for the three
months ended September 30, 2023. The amounts of interest are comprised of accretion of debt discount being amortized in 2024 and 2023
from associated discounts related to convertible notes and placement agent warrants, together with interest expenses from the issuances
of convertible notes.
Nine
Months Ended September 30, 2024 Compared to Nine Months Ended September 30, 2023
The
following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:
| |
September 30, | |
(In thousands) | |
2024 | | |
2023 | |
Expenses: | |
| | |
| |
Research and development expenses | |
$ | 1,968,591 | | |
$ | 2,197,936 | |
General and administrative | |
| 1,878,831 | | |
| 987,677 | |
Total operating expenses | |
| 3,847,422 | | |
| 3,185,613 | |
| |
| | | |
| | |
Loss from operations | |
| (3,847,422 | ) | |
| (3,185,613 | ) |
| |
| | | |
| | |
Other income (expenses): Interest Income | |
| 1 | | |
| 2 | |
Interest expense | |
| (2,044,283 | ) | |
| (3,141,405 | ) |
Total other expenses | |
| (2,044,282 | ) | |
| (3,141,403 | ) |
| |
| | | |
| | |
Net loss | |
| (5,891,704 | ) | |
| (6,327,016 | ) |
Cumulative Series A preferred stock dividend requirement | |
| (31,250 | ) | |
| (93,750 | ) |
Net loss available to common shareholders | |
$ | (5,922,954 | ) | |
$ | (6,420,766 | ) |
Research and Development
Expenses. Research and development expenses were approximately $1.9 million for the nine months ended September 30, 2024
compared to approximately $2.2 million for the nine months ended September 30, 2023. This decrease was primarily due to a decrease
in vendor expenses associated with our Phase IIb clinical trial and a decrease in vendor expenses associated with out OST-tADC platform
technology. The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and
2023:
| |
As of September 30, | |
(In thousands) | |
2024 | | |
2023 | |
Direct research and development expenses by program: | |
| | |
| |
OST-HER2 | |
$ | 1,551 | | |
$ | 1,683 | |
OST-tADC | |
| — | | |
| 214 | |
| |
| | | |
| | |
Unallocated research and development expenses: | |
| | | |
| | |
Personnel-related | |
| 418 | | |
| 301 | |
Total research and development expenses | |
$ | 1,969 | | |
$ | 2,198 | |
For the nine months ended
September 30, 2024 and 2023, the direct research and development expenses related to OST-HER2 were primarily lab fees, vendor expenses
and staff payroll fees. In 2024, such expenses were primarily lab fees and related clinical support of approximately $1.6 million attributed
to our Phase IIb clinical trial preparation and CRO costs as we completed IND-enabling studies. OST-tADC related direct research and development
expenses were approximately $0.0 million and $0.2 million for the nine months ended September 30, 2024 and 2023, respectively.
General
and Administrative Expenses. General and administrative expenses for the nine months ended September 30, 2024 were approximately
$1.9 million compared to $1.0 million for the nine months ended September 30, 2023. These expenses were primarily attributed
to marketing costs and accounting fees to consultants.
Licensing
Costs. We did not have any licensing costs for the nine months ended September 30, 2024 and 2023.
Interest
Expense. Interest expense for the nine months ended September 30, 2024 was approximately $2.0 million compared to $3.1 million
for the nine months ended September 30, 2023. The amounts of interest are comprised of accretion of debt discount being amortized in
2024 and 2023 from associated discounts related to convertible notes and placement agent warrants, together with interest expenses from
the issuances of convertible notes.
Liquidity
and Capital Resources
Operating
Losses
Since our inception, we have
incurred significant operating losses. Our ability to generate product revenue sufficient to achieve profitability will depend heavily
on the successful development and eventual commercialization of our product candidates. For the nine months ended September 30, 2024 and
2023, we reported a net loss of approximately $5.9 million and $6.4 million, respectively, and had an accumulated deficit of approximately
$35.4 million and $28.0 million, respectively. We expect to incur significant expenses at an increasing rate and increasing operating
losses for the foreseeable future.
As of September 30, 2024
and 2023, we had cash of approximately $1.9 million and $0.02 million, respectively. We have funded our operations to date primarily from
the sale of our convertible notes in our private placements, which have provided total gross proceeds of $19.2 million as of July 31,
2024. We believe that the net proceeds from our private placements, together with our existing cash, will enable us to fund our operating
expenses and capital expenditure requirements for the next three to nine months.
We
consummated our initial public offering on August 2, 2024, converting all our outstanding Convertible Notes into common stock and raising
$6.4 million in gross proceeds on the sale of 1.6 million shares of our common stock. Net proceeds from our initial public offering were
used to pay off accounts payable and fund continuing losses through September 30, 2024.
Cash
Flows
The
following table summarizes our sources and uses of cash for each of the periods presented:
| |
September 30, | |
(In thousands) | |
2024 | | |
2023 | |
Cash used in operating activities | |
$ | (4,908 | ) | |
$ | (2,135 | ) |
Cash provided by investing activities | |
| — | | |
| 1 | |
Cash provided by financing activities | |
| 6,727 | | |
| 1,979 | |
Net increase (decrease) in cash | |
$ | 1,819 | | |
$ | (155 | ) |
Operating
Activities
During
the nine months ended September 30, 2024 and 2023, operating activities used approximately $4.9 million and $2.1 million of cash,
respectively, resulting from our net loss of approximately $5.9 million and $6.3 million, respectively, offset by net non-cash charges
of approximately $1.4 million and $2.6 million, respectively, partially offset by net cash provided by changes in our operating
assets and liabilities of approximately $(0.4) million and $1.6 million, respectively.
Net cash provided by changes
in our operating assets and liabilities for the nine months ended September 30, 2024 and 2023 consisted primarily of an increase (decrease)
in accounts payable of approximately $(0.9) million and $1.1 million, respectively, an increase in accrued interest of approximately
$0.6 million and $0.7 million, respectively, and a change in accrued payroll of approximately $(0.1) million and $(0.1) million,
respectively.
Non-cash
charges for the nine months ended September 30, 2024 and 2023 were primarily the result of the amortization of debt discount on our convertible
debt of approximately $1.4 million and $2.4 million, respectively. Changes in accounts payable, accrued expenses and other current
liabilities and prepaid expenses and other current assets in all periods were generally due to growth in our business, the advancement
of our research programs and the timing of vendor invoicing and payments.
Investing
Activities
During
the nine months ended September 30, 2024 and 2023, net cash provided by investing activities was approximately $0.0 million and $0.0 million,
respectively.
Financing
Activities
During
the nine months ended September 30, 2024 and 2023, net cash provided by financing activities was approximately $6.7 million and $2.0 million,
respectively. The net cash provided by financing activities for the nine months ended September 30, 2024 and 2023 consisted of net proceeds
from sales of convertible notes and our initial public offering, reduced by capitalized deferred offering costs.
Convertible
Notes
We
have completed seven separate private financing transactions from July 2018 to April 2024 in which we issued the Convertible Notes
and raised total gross proceeds of $19,186,520 from accredited investors.
Information
with respect to the seven separate private financings of convertible notes — A, B, C, D, E, F and BlinkBio — are
indicated in the table below.
Group | |
Dates of
issuance | | |
Rate | | |
Maturity | |
Collateral | |
Conversion
rate | | |
September 30,
2024 carrying amount | | |
December 31,
2023 carrying amount | | |
Convertible Note
ceiling range on note valuation | |
| |
| | |
(in millions) | |
A | |
| 2018 – 2021 | | |
| 10% | | |
10/31/2024 | |
None | |
| 80% – 87.5 | % | |
$ | — | | |
$ | 1.2 | | |
$ | 5
to 25 – varies per note | |
B | |
| 2020 – 2021 | | |
| 6% | | |
10/31/2024 | |
None | |
| 80 | % | |
$ | — | | |
$ | 5.2 | | |
$ | 19 | |
C | |
| 2021 – 2023 | | |
| 6% | | |
10/31/2024 | |
None | |
| 80 | % | |
$ | — | | |
$ | 3.9 | | |
$ | 19
or 50 – varies per note | |
D | |
| 2022
– 2023 | | |
| 6% | | |
10/31/2024 | |
None | |
| 50 | % | |
$ | — | | |
$ | 2.0 | | |
$ | 50 | |
E | |
| 2023 | | |
| 6% | | |
10/31/2024 | |
None | |
| 50 | % | |
$ | — | | |
$ | 1.1 | | |
$ | 50 | |
F | |
| 2023
– 2024 | | |
| 6% | | |
10/31/2024 | |
None | |
| 50 | % | |
$ | — | | |
$ | 1.4 | | |
$ | 50 | |
BlinkBio | |
| 2020 | | |
| 10% | | |
3/15/2022 | |
None | |
| 100 | % | |
$ | — | | |
$ | — | | |
$ | 19.2 | |
The total accrued interest
on the convertible notes listed in the table above was approximately $0.0 million and $2.0 million as of September 30, 2024 and December
31, 2023, respectively. The carrying amount and face amount of such convertible notes differ because of the unamortized debt issuance
costs and the debt discount (which are amortized over the original term of the instrument) — see accounting policy discussion
below. The material terms of each group of Convertible Notes are described below. The Convertible Notes, including interest accrued thereon,
automatically converted into common stock upon consummation of our initial public offering on August 2, 2024.
Group
A Convertible Notes. From July 2018 through November 2021, we issued convertible notes in an aggregate principal amount
of $1,154,000 (the “Group A Convertible Notes”) to accredited investors, including related parties. Interest on the unpaid
principal balance on the Group A Convertible Notes accrued at a rate of 10% per annum, computed on the basis of the actual number of days
elapsed and a year of 365 days. Unless earlier converted into shares of Equity Securities, the principal and accrued interest on
the Group A Convertible Notes were due and payable by us on demand by the holders of such convertible notes at any time after the earlier
of (i) the Maturity Date and (ii) the closing of the Next Equity Financing (which was our initial public offering). In general,
the stated Maturity Date varied from the date of issuance of two to four years and was extended in October 2023, under the
same terms, until October 31, 2024.
The
Group A Convertible Notes automatically converted into shares of our common stock upon the consummation of our initial public offering.
The number of shares of our common stock issued upon the automatic conversion was equal to the quotient obtained by dividing the outstanding
principal and unpaid accrued interest due on the Group A Convertible Note on the date of conversion by a percentage between 80% to 87.5%,
as applicable, of the initial public offering price per share in such offering. The Group A Convertible Notes had conversion capitalization
ceilings that ranged from $5 million to $25 million, which limited the price a noteholder must pay in a convertible note-to-common
stock conversion occurrence. The Group A Convertible Notes had a conversion price that ranged from $0.39 to $1.97 per share, depending
on the applicable valuation ceiling of each note (based on the initial public offering price of $4.00 per share).
Group
B Convertible Notes. From April 2020 through June 2021, we issued convertible notes in an aggregate principal amount
of $5,154,000 (the “Group B Convertible Notes”) to accredited investors. Interest on the unpaid principal balance of the
Group B Convertible Notes accrued at a rate of 6% per annum, computed on the basis of the actual number of days elapsed and a year
of 365 days. Unless earlier converted into shares of Equity Securities, the principal and accrued interest were due and payable
by us on demand by the convertible holders of such notes at any time after the earlier of (i) the Maturity Date and (ii) the
closing of the Next Equity Financing (which was our initial public offering). In general, the stated Maturity Date was March 31,
2022 but was extended in October 2023, under the same terms, until October 31, 2024.
The
Group B Convertible Notes automatically converted into shares of our common stock upon the consummation of our initial public offering.
The number of shares of our common stock issued upon the automatic conversion was equal to the quotient obtained by dividing the outstanding
principal and unpaid accrued interest due on the Group B Convertible Note on the date of conversion by 80% of the initial public offering
price per share in such offering. The Group B Convertible Notes had a conversion capitalization ceiling of $19 million, which limited
the price a noteholder must pay in a convertible note-to-common stock conversion occurrence. As a result of the valuation ceiling, the
Group B Convertible Notes had a conversion price of $1.31 per share (based on the initial public offering price of $4.00 per share).
Group
C Convertible Notes. From June 2021 through January 2023, we issued convertible notes in an aggregate principal amount of
$3,945,020 (the “Group C Convertible Notes”) to accredited investors. Interest on the unpaid principal balance of the Group
C Convertible Notes accrued at a rate of 6% per annum, computed on the basis of the actual number of days elapsed and a year of
365 days. Unless earlier converted into shares of Equity Securities, the principal and accrued interest were due and payable by
us on demand by the holders of such convertible notes at any time after the earlier of (i) the Maturity Date and (ii) the closing
of the Next Equity Financing (which was our initial public offering). In general, the stated Maturity Date was May 31, 2024 but
was extended in October 2023, under the same terms, until October 31, 2024.
The
Group C Convertible Notes automatically converted into shares of our common stock upon the consummation of our initial public
offering. The number of shares of our common stock issued upon the automatic conversion was equal to the quotient obtained by
dividing the outstanding principal and unpaid accrued interest due on the Group C Convertible Note on the date of conversion by 80%
of the initial public offering price per share in such offering. The Group C Convertible Notes had a conversion capitalization
ceiling of $50 million, except that one note was subject to a valuation ceiling of $19 million, which limited the price a noteholder
must pay in a convertible note-to-common stock conversion occurrence. As a result of the applicable valuation ceiling, the Group C
Convertible Notes had a conversion price of $1.31 or $2.59 per share, as applicable (based on the initial public offering price of
$4.00 per share).
Bridge
Notes (Groups D, E and F). In November 2022, we issued convertible notes in an aggregate principal amount of $2,000,000
(the “Group D Convertible Notes”) to accredited investors. From February to June 2023, we issued convertible notes in an
aggregate principal amount of $1,100,000 (the “Group E Convertible Notes”) to accredited investors. From June 2023 to April
2024, we issued convertible notes in an aggregate principal amount of $3,433,500 (the “Group F Convertible Notes” and,
collectively with the Group D Convertible Notes and Group E Convertible Notes, the “Bridge Notes”) to accredited investors,
of which an aggregate of $750,000 was issued in April 2024. Interest on the unpaid principal balance of the Bridge Notes accrued at a
rate of 6% per annum, computed on the basis of the actual number of days elapsed and a year of 365 days. Unless earlier converted
into shares of Equity Securities, the principal and accrued interest was due and payable by us on demand by the holders of such convertible
notes at any time after the earlier of (i) the Maturity Date and (ii) the closing of the Next Equity Financing (which was our
initial public offering). In general, the stated Maturity Date was October 31, 2024.
The
Bridge Notes automatically converted into shares of our common stock upon the consummation of our initial public offering. The number
of shares of our common stock issued upon the automatic conversion was equal to the quotient obtained by dividing the outstanding principal
and unpaid accrued interest due on a Bridge Note on the date of conversion by 50% of the initial public offering price per share in such
offering. The Bridge Notes had a conversion capitalization ceiling of $50 million, which limited the price a noteholder must pay
in a convertible note-to-common stock conversion occurrence. As a result of the valuation ceiling, the Bridge Notes had a conversion
price of $2.00 per share (based on the initial public offering price of $4.00 per share).
Demand
Notes. On March 6, 2024 and June 28, 2024, we issued demand promissory notes to a lender who was an investor in one of our prior
convertible notes rounds in a principal amount of $100,000 and $150,000, respectively. The demand notes bear interest at a rate of 8%
per annum and the principal plus all accrued interest is payable upon demand by such lender. If such notes are not paid on demand by
us, interest will accrue at a rate of the lesser of 16% per annum and the highest rate of interest allowable under Maryland law.
As
of August 14, 2024, we have repaid the demand notes in full.
BlinkBio.
On August 19, 2020, we issued a convertible note with a principal amount of $2,400,000 (the “BlinkBio Convertible
Note”) to BlinkBio, Inc., which is a related party based on Dr. Goddard being our Chairman and as the Chairman and Chief Executive
Officer of BlinkBio, in exchange for the entry into the license agreement. On March 15, 2021, the principal and unpaid accrued interest
of $100,000 of the BlinkBio Convertible Note converted into 1,302,082 shares of our Series A preferred stock and then distributed
to BlinkBio stockholders. The BlinkBio Convertible Note had a conversion capitalization ceiling of $19.2 million, which limited
the price a noteholder must pay in a convertible note-to-common stock conversion occurrence. On February 9, 2024, the 1,302,082 shares
of our Series A preferred stock were converted into 651,041 shares of common stock (on a post-split basis).
TEDCO
Grant. In May 2021, we received the first of two tranches from TEDCO’s Rural & Underserved Business Recovery
from Impact of Covid-19 (RUBRIC) Grant in the amount of $50,000. In October 2021, we received the second tranche of $50,000, which
brought the total reimbursable grant amount to $100,000. We are obligated to report on and pay to TEDCO 3% of their quarterly revenues
for a five-year period following the reward date. Income from grants and investments are not considered revenues. Royalties due to TEDCO
are capped at 150% of the amount of the award, or $150,000. We have the option to eliminate the quarterly royalty obligation by making
an advance payment prior to the end of the five-year period, in which case, we will receive a 10% reduction of the royalty cap percentage
for each year prior to the expiration of the five-year reimbursement period that the grant is repaid in full. If we cease to meet eligibility
requirements at any time, the reimbursement obligation will become due to TEDCO immediately; however, the discount for meeting the obligation
will still apply.
Contractual
Obligations and Other Commitments
We
enter into contracts in the normal course of business with our CDMOs, CROs and other third parties to support preclinical research studies
and testing and other development activities. These contracts are generally cancellable by us. Payments due upon cancellation consist
only of payments for services provided or expenses incurred, including non-cancellable obligations of our service providers, up to the
date of cancellation.
License
Obligations and Research Services
Advaxis.
In November 2020, we entered into an amended and restated development, license and supply agreement with Advaxis, Inc. (now
Ayala Pharmaceuticals, Inc.) (“Advaxis”), a clinical-stage biotechnology company focused on the development and commercialization
of proprietary Lm (Listeria monocytogenes)-LLO (Listeriolysin O) cancer immunotherapies. Pursuant to this agreement, Advaxis
granted a license to us that allows us to utilize Advaxis’ ADXS-HER2 construct patents to develop and commercialize ADXS-HER2,
our lead product candidate (OST-HER2). The agreement was subsequently amended in April 2021 to modify the payment amounts for Milestones
2 and 3 listed in the table below. Under the terms of the amended agreement, we are required to pay to Advaxis (i) a one-time, non-refundable
payment of $1,550,000 (the “License Commencement Payment”) and (ii) certain amounts based on the achievement of the
milestones described in the payment schedule below. As of September 30, 2024, we paid to Advaxis a total of $2,925,000, consisting of
(i) the License Commencement Payment for Milestone 1 and (ii) $1,375,000 for Milestone 2.
Payments
towards the License Commencement Payment have been recorded as licensing expenses in our Statement of Operations and Comprehensive Loss
for the year ended December 31, 2022. We expect to achieve Milestone 3 in March 2025. The payment schedule for milestones and
corresponding payment amounts is set forth below.
Milestone | |
Milestone Payment | |
1. OST has secured funding of at least $2,337,500, in the aggregate (paid) | |
| License commencement payment: | |
| |
$ | 1,550,000 | |
2. The earlier to occur of: (A) OST having secured at least $8,000,000, in the aggregate, or (B) completion of the first Clinical Trial (paid) | |
$ | 1,375,000 | |
3. The earlier to occur of: (A) receipt of Regulatory Approval from the FDA for the First Indication of the first Licensed Product or (B) initiation of the first Registrational Trial of the first Licensed Product in the Field | |
$ | 5,000,000 | |
4. Cumulative Net Sales of all Licensed Products in excess of $20,000,000 | |
$ | 1,500,000 | |
5. Cumulative Net Sales of all Licensed Products in excess of $50,000,000 Cumulative Net Sales of all Licensed Products in ex | |
$ | 5,000,000 | |
6. Cumulative Net Sales of all Licensed Products in excess of $100,000,000 | |
$ | 10,000,000 | |
All
milestone payments are non-creditable and non-refundable and are due and payable upon the achievement of the milestone, regardless of
any failure by us to provide notice to Advaxis of such achievement.
In
addition to the payments upon achievement of the milestones listed in the above payment schedule, we are required to pay to Advaxis (i)
a percentage in the high single digits to low double digits of (a) upfront sublicense fees or (b) clinical or regulatory milestone
payment amounts, paid by a sublicensee to us in consideration of a sublicense grant to such sublicensee, and (ii) a quarterly royalty
of a percentage in the high single digits to low double digits of net sales of our products containing the ADXS-HER2 constructs.
BlinkBio.
In August 2020, we entered into a licensing agreement with BlinkBio, Inc., a privately-held developer of drug conjugate
therapies designed to facilitate the treatment of cancer. Pursuant to this agreement, BlinkBio granted a license to us that allows us
to utilize BlinkBio’s proprietary technology to develop, manufacture and commercialize certain of our products. BlinkBio granted
us an exclusive license for tunable drug conjugates that are directed towards, binds to or modifies the folate receptor alpha and a co-exclusive
license for tunable drug conjugates that are directed towards, binds to or modifies any target other than the folate receptor alpha,
such as HER2.
Under
the terms of the agreement, we are required to pay to BlinkBio (i) an upfront, non-refundable, non-creditable license fee of $300,000
(the “Up-Front Fee”), (ii) a royalty of 6% of net sales of our products that were made using BlinkBio’s proprietary
technology, subject to potential reductions on such royalty, and (iii) certain amounts based on the achievement of the milestones
described in the payment schedule below.
As
of September 30, 2024, we had paid the Up-Front Fee. The payment schedule for milestones and corresponding payment amounts is set forth
below.
Milestone Bearing Event | |
Milestone Payment | |
1. License Fee to utilize proprietary technology (paid) | |
| Up-front fee + $2.4 million Convertible Note | |
2. Commencement of a toxicology study commented pursuant to Good Laboratory Practices (under 21 CFR Part 58), such that any resulting positive data would be admissible to applicable Regulatory Authorities to support an IND (commonly referred to as “GLP-Tox”) | |
$ | 375,000 | |
3. Completion of a Phase I Clinical Trial | |
$ | 1,500,000 | |
4. Completion of a Phase IIb Clinical Trial | |
$ | 2,500,000 | |
5. Filing of an NDA, BLA or MAA registration (or the equivalent in any other territory around the world) | |
$ | 6,000,000 | |
6. Regulatory Approval in the first of the United States, within the European Union or within the United Kingdom | |
$ | 12,000,000 | |
We
are required to make the above cash payments to BlinkBio within 30 days of the achievement of each milestone with respect to the
first product to attain each such milestone, except that the first milestone only applies to our first product candidate. The aggregate
amount of payments relating to milestones 2 through 6 payable thereunder cannot exceed $22,375,000.
In
connection with the license agreement, we also agreed to issue the BlinkBio Convertible Note. See “— Convertible Notes”
above for more information on the BlinkBio Convertible Note.
George Clinical. In
June 2020, we entered into a services agreement, as amended, with George Clinical, Inc., a clinical contract research organization.
Pursuant to this agreement, we engaged George Clinical to use its clinical research services for our study entitled “An Open Label,
Phase 2 Study of Maintenance Therapy with OST-HER2 after Resection of Recurrent Osteosarcoma.” Under the terms of the agreement,
we are required to pay to George Clinical certain fees described in the fee schedule below. The total new budget under the agreement is
approximately $2,436,928. For the nine months ended September 30, 2024 and year ended December 31, 2023, we paid $345,836 and $921,300,
respectively, to George Clinical. These payments have been recorded as research and development expenses in our Statement of Operations
and Comprehensive Loss. The fee schedule for certain fees and corresponding payment amounts is set forth below.
George
Clinical Payment Schedule |
|
Payment
Amount |
|
1. Service Fee Advance (paid) |
|
$ |
49,989 |
|
2. Service Fee Advance of $212,335 minus the amount already paid, plus PTC Fee Advance of $31,325 (paid) |
|
$ |
193,671 |
|
3. Statistics Fees – 35% on Electronic Data Capture (EDC) Go Live Date |
|
$ |
47,740 |
|
4. Statistics Fees – 35% on Development of SAP tables |
|
$ |
47,740 |
|
5. Statistics Fees – 30% on Final Analysis |
|
$ |
40,920 |
|
6. Service Fees – Remainder Due |
|
|
Split monthly
over course
of study |
|
George
Clinical tracks and invoices us for the number of task units completed and pass-through costs are invoiced each month in arrears based
on actual costs without mark-up. The PTC Fee Advance will be used to offset the first few months of invoices payable. As of September
30, 2024, the balance due to George Clinical was $295,082.
Off-Balance
Sheet Arrangements
We
did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules
and regulations of the SEC.
Recent
Accounting Pronouncements
A
description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations
is disclosed in Note 2 to Notes to the Financial Statements appearing elsewhere in this report.
The
JOBS Act
The
JOBS Act permits an emerging growth company such as us to take advantage of an extended transition period to comply with new or revised
accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected
to avail ourselves of the extended transition period for complying with new or revised financial accounting standards.
We
will remain an emerging growth company until the earliest of (i) the last day of our first fiscal year in which we have total
annual gross revenues of $1.235 billion or more; (ii) the date on which we are deemed to be a “large accelerated filer”
under the rules of the SEC with at least $700.0 million of outstanding equity securities held by non-affiliates; (iii) the
date on which we have issued more than $1.0 billion in non-convertible debt securities during the previous three years; or
(iv) the last day of our fiscal year following the fifth anniversary of the date of the completion of our initial public offering.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Not
applicable.
Item
4. Controls and Procedures.
Disclosure
controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange
Act”)) are controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports
that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the
rules and forms of the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure
that information required to be disclosed in the reports that we file under the Exchange Act is accumulated and communicated to our management,
including our principal executive officer and our principal financial officer, as appropriate, to allow timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures,
no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. Due to the
inherent limitations of control systems, not all misstatements may be detected. These inherent limitations include the realities that
judgments in decision-making can be faulty and that breakdowns can occur because of a simple error or mistake. Additionally, controls
can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control.
Controls and procedures can only provide reasonable, not absolute, assurance that the above objectives have been met.
The
Company’s management, including its Chief Executive Officer and Chief Financial Officer, have conducted an evaluation of the effectiveness
of disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of
1934, as amended), as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, the Chief Executive
Officer and Chief Financial Officer concluded as of September 30, 2024, that the disclosure controls and procedures are not effective
due to lack of segregation of duties as a result of limited personnel and insufficient written policies and procedures for accounting,
information technology and financial reporting.
There
have not been any changes in the Company’s internal control over financial reporting that occurred during the first, second or
third quarter of 2024 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control
over financial reporting.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings.
We
are not currently a party to any pending or threatened legal proceedings other than the arbitration proceeding described below.
On
April 12, 2024, Noble Capital Markets, Inc. (“Noble”) filed a Demand for Arbitration against us in JAMS, claiming that
we breached the anti-dilution provision in the parties’ advisory agreement by not issuing to Noble an additional 474,134 shares
of our common stock. In September 2024, we settled the matter with Noble in exchange for $50,000 and 320,033 shares of our
common stock, which were issued during September 2024.
See
also Note 6 to our financial statements contained in Item 1 of Part I of this Quarterly Report on Form 10-Q, which is incorporated herein
by reference.
Item
1A. Risk Factors.
You
should carefully consider the factors discussed under the section entitled “Risk Factors” in our Registration Statement on
Form S-1 (File No. 333-283171), initially filed with the SEC on November 1, 2024, as such factors could materially affect our business,
financial condition, and future results. The risks described in such registration statement are not the only risks that we face. Additional
risks and uncertainties not currently known to us, or that we currently deem to be immaterial, also may have a material adverse impact
on our business, financial condition, or results of operations.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
Unregistered
Sales of Equity Securities by the Issuer
On October 31, 2024,
we entered into the Equity Purchase Agreement with the Investor, pursuant to which we will have the right, but not the obligation, to
sell to the Investor, and the Investor will have the obligation to purchase from us, up to the Maximum Commitment Amount worth of shares
of our common stock, at our sole discretion, over the next 24 months, subject to certain conditions precedent and other limitations set
forth in the Equity Purchase Agreement. Concurrently with the execution of the Equity Purchase Agreement, we also agreed to issue to
the Investor, as part of the consideration, shares of the Company’s common stock worth a total of 3% of the Maximum Commitment
Amount (the “Initial Commitment Shares”). The ultimate calculation of the per share price of the Initial Commitment Shares
will occur on the date immediately prior to a registration statement on Form S-1 covering the resale of the shares to be issued pursuant
to the Equity Purchase Agreement.
The shares of common stock
are being offered and sold by us to the Investor pursuant to the Equity Purchase Agreement in reliance upon an exemption from the registration
requirements of the Securities Act afforded by Section 4(a)(2) of the Securities Act of 1933 and Rule 506(b) of Regulation D promulgated
thereunder.
Use
of Proceeds
On July 31, 2024, our registration
statement on Form S-1 (File No. 333-276350) was declared effective by the SEC for our initial public offering, which was underwritten
by Brookline Capital Markets. At the closing of our initial public offering on August 2, 2024, we sold 1,600,000 shares of common stock
at an initial public offering price of $4.00 per share and received gross proceeds of $6.4 million, which resulted in net proceeds to
us of approximately $6.0 million, after deducting underwriting discounts and commissions of approximately $0.4 million. As of November
14, 2024, we estimate that we have used approximately $5.5 million of the proceeds from our initial public offering for general corporate
purposes, including to advance the development of OST-HER2 and OST-tADC. There has been no material change in the planned use of proceeds
from that described in the final prospectus for our initial public offering filed with the SEC pursuant to Rule 424(b)(4) under the Securities
Act.
Item
6. Exhibits.
The
following exhibits are filed with this Quarterly Report on Form 10-Q:
Exhibit
No. |
|
Description |
10.1 |
|
Equity Purchase Agreement, dated as of October 31, 2024, between OS Therapies Incorporated and Square Gate Capital Master Fund, LLC-Series 3 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on November 1, 2024).+ |
|
|
|
10.2 |
|
Registration Rights Agreement, dated October 31, 2024 (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the SEC on November 1, 2024).+ |
|
|
|
31.1 |
|
Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2 |
|
Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32* |
|
Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. § 1350 As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
101 |
|
The
following financial statements from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, formatted
in Inline XBRL: (i) Balance Sheets as of September 30, 2024 and December 31, 2023 (unaudited); (ii) Statements of Operations for
the three and nine months ended September 30, 2024 and 2023 (unaudited); (iii) Statements of Stockholders’ Deficit for the
three and nine months ended September 30, 2024 and 2023 (unaudited); (iv) Statements of Cash Flows for the nine months ended September
30, 2024 and 2023 (unaudited); and (v) Notes to the Financial Statements (unaudited). |
|
|
|
104 |
|
The
cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, formatted in Inline XBRL
(included as Exhibit 101). |
| + | Certain
exhibits and/or schedules to this exhibit have been omitted pursuant to Item 601(a)(5) or Item 601(b)(10)(iv), as applicable, of Regulation
S-K. The Company agrees to furnish supplemental copies of all omitted exhibits to the SEC upon its request. |
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.
|
OS
THERAPIES INCORPORATED |
|
|
|
Date:
November 15, 2024 |
By: |
/s/
Paul Romness |
|
|
Paul
Romness |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
Date:
November 15, 2024 |
By: |
/s/
Christopher Acevedo |
|
|
Christopher
Acevedo |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
38
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1. I have reviewed this quarterly
report on Form 10-Q of OS Therapies Incorporated;
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 15d-15(f))
for the registrant and have:
(a) Designed such disclosure
controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
(b) Designed such internal
control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness
of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report
any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter 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.
1. I have reviewed this quarterly
report on Form 10-Q of OS Therapies Incorporated;
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 15d-15(f))
for the registrant and have:
(a) Designed such disclosure
controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
(b) Designed such internal
control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness
of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report
any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter 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.
I, Paul Romness, certify, pursuant to 18 U.S.C.
§ 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report on Form 10-Q of OS Therapies
Incorporated for the quarter ended September 30, 2024, fully complies with the requirements of Section 13(a) or 15(d) of the Securities
Exchange Act of 1934 and that the information contained in such Quarterly Report on Form 10-Q fairly presents, in all material respects,
the financial condition and results of operations of OS Therapies Incorporated at the dates and for the periods indicated.
I, Christopher Acevedo, certify, pursuant to 18
U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report on Form 10-Q of OS
Therapies Incorporated for the quarter ended September 30, 2024, fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934 and that the information contained in such Quarterly Report on Form 10-Q fairly presents, in all material
respects, the financial condition and results of operations of OS Therapies Incorporated at the dates and for the periods indicated.
The foregoing certification is being furnished
solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United
States Code) and is not being filed as part of the Quarterly Report on Form 10-Q of OS Therapies Incorporated for the quarter ended September
30, 2024 or as a separate disclosure document.
A signed original of this written statement required
by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within
the electronic version of this written statement required by Section 906, has been provided to OS Therapies Incorporated and will be retained
by OS Therapies Incorporated and furnished to the Securities and Exchange Commission or its staff upon request.