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: March 31, 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: 333-271034
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.)
15825 Shady Grove Road , Suite 135
Rockville , Maryland 20850
(Address of principal executive offices) (Zip Code)
(410)
297-7793
(Registrant’s
telephone number, including area code)
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act: None
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 May 9, 2024 was 11,982,082 .
TABLE
OF CONTENTS
OS
THERAPIES INCORPORATED
Page
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
1
Balance
Sheets as of March 31, 2024 and December 31, 2023 (unaudited)
1
Statements of Operations for the three months ended March 31, 2024 and 2023 (unaudited)
2
Statements of Stockholders’ Deficit for the three months ended March 31, 2024 and 2023 (unaudited)
3
Statements of Cash Flows for the three months ended March 31, 2024 and 2023 (unaudited)
4
Notes to the Financial Statements (unaudited)
5
Item 2. Management ’ s Discussion and Analysis of Financial Condition and Results of Operations.
22
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
33
Item 4. Controls and Procedures.
33
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
34
Item 1A. Risk Factors.
34
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
34
Item 6. Exhibits.
35
i
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
OS
Therapies Incorporated
Balance Sheets
(unaudited)
March 31,
2024
December 31,
2023
ASSETS
Current Assets
Cash
$ 100,231
$ 38,982
Deferred Offering Costs
941,338
751,050
Total Current Assets
1,041,569
790,032
Long Term Assets
Fixed Assets (Net)
7,355
8,050
TOTAL ASSETS
$ 1,048,924
$ 798,082
LIABILITIES AND STOCKHOLDERS’ Deficit
Current Liabilities
Accounts Payable
$ 2,799,120
$ 2,715,399
Accrued Interest on Convertible Notes
2,276,347
2,026,323
Accrued Expenses
162,500
162,500
Accrued Payroll and Payroll Taxes – Related Party
42,676
112,137
Accrued Payroll and Payroll Taxes
49,357
33,543
Redemption Premium
5,055,804
4,580,304
Short-Term Loan
100,000
—
Preferred Dividends Payable
375,000
343,750
Convertible Notes – A (Net Debt Discount)
1,053,383
1,051,032
Convertible Notes – A (Related Party Net Debt Discount)
100,000
100,000
Convertible Notes – B (Net Debt Discount)
5,154,000
5,154,000
Convertible Notes – C (Net Debt Discount)
3,945,020
3,873,417
Convertible Notes – D (Net Debt Discount)
2,000,000
1,950,160
Convertible Notes – E (Net Debt Discount)
1,100,000
1,100,000
Convertible Notes – F (Net Debt Discount)
2,112,174
1,381,732
Make-whole Stock Liability
130,000
130,000
Total Current Liabilities
26,455,381
24,714,297
Long-Term Liabilities
TEDCO Grant
100,000
100,000
Total Long-Term Liabilities
100,000
100,000
Total Liabilities
26,555,381
24,814,297
STOCKHOLDERS’ DEFICIT
Common Stock, par value $ 0.001 , 50,000,000 shares authorized, 11,982,082 and 10,680,000 issued and outstanding, respectively
11,982
10,680
Preferred Stock, par value $ 0.001 , 5,000,000 shares authorized, 0 and 1,302,082 shares Preferred Stock A issued and outstanding, respectively
—
1,302
Additional paid-in capital
5,489,990
5,489,990
Accumulated deficit
( 31,008,429 )
( 29,518,187 )
Total Stockholders’ Deficit
( 25,506,457 )
( 24,016,215 )
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT
$ 1,048,924
$ 798,082
The
accompanying notes are an integral part of these unaudited financial statements.
1
OS
Therapies Incorporated
Statements of Operations
(unaudited)
For the three months ended
March 31,
2024
2023
OPERATING EXPENSES
Research & Development
$ 361,809
$ 753,784
General & Administrative
268,423
294,247
Loss from Operations
( 630,232 )
( 1,048,031 )
OTHER INCOME/EXPENSE
Interest Expense
( 828,760 )
( 798,938 )
Total Other Expense
( 828,760 )
( 798,938 )
NET LOSS
( 1,458,992 )
( 1,846,969 )
Cumulative Series A Preferred Stock Dividend Requirement
( 31,250 )
( 31,250 )
NET LOSS available to common shareholders
$ ( 1,490,242 )
$ ( 1,878,219 )
Weighted Average # of Shares – Class A
11,409,692
10,213,333
Basic & Diluted Loss per Common Share – Class A
$ ( 0.13 )
$ ( 0.18 )
The
accompanying notes are an integral part of these unaudited financial statements .
2
OS
Therapies Incorporated
Statements of Stockholders’ Deficit
For the Three Months Ended March 31, 2024 and 2023
(unaudited)
Common Stock
CS – Shares
CS – Par
Amount
Preferred Stock
Shares Par
Amount
Additional
Paid-in
Capital
Accumulated
Deficit
Total
Stockholders’
Deficit
Balances, December 31, 2022
9,980,000
$ 9,980
1,302,082
$ 1,302
$ 4,033,093
$ ( 21,601,603 )
$ ( 17,557,228 )
Conversion of Make Whole Liability to Common Stock
700,000
700
—
—
699,300
—
700,000
Preferred Dividends
—
—
—
—
—
( 31,250 )
( 31,250 )
Net loss
—
—
—
—
—
( 1,846,969 )
( 1,846,969 )
Balances, March 31, 2023
10,680,000
$ 10,680
1,302,082
$ 1,302
$ 4,732,393
$ ( 23,479,822 )
$ ( 18,735,447 )
Balances, December 31, 2023
10,680,000
$ 10,680
1,302,082
$ 1,302
$ 5,489,990
$ ( 29,518,187 )
$ ( 24,016,215 )
Conversion of Preferred Stock to Common Stock
1,302,082
1,302
( 1,302,082 )
( 1,302 )
—
—
—
Preferred Dividends
—
—
—
—
—
( 31,250 )
( 31,250 )
Net Loss
—
—
—
—
—
( 1,458,992 )
( 1,458,992 )
Balances, March 31, 2024
11,982,082
$ 11,982
—
$ —
$ 5,489,990
$ ( 31,008,429 )
$ ( 25,506,457 )
The
accompanying notes are an integral part of these unaudited financial statements .
3
OS
Therapies Incorporated
Statements of Cash Flows
For the Three Months Ended March 31, 2024 and 2023
(unaudited)
Three Months Ended
March 31,
2024
Three Months Ended
March 31,
2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$ ( 1,458,992 )
( 1,846,969 )
Depreciation expense
695
100
Amortization of Debt Discounts Issuance and Warrants
578,736
616,153
Make-whole expense
—
116,688
Adjustments to reconcile net loss to net cash used in operating activities:
Accounts Payable
41,453
446,028
Accrued Expenses
—
10,000
Accrued Interest on Convertible Notes
250,025
182,785
Accrued Payroll and payroll taxes
( 53,646 )
47,029
Net cash used in operating activities
( 641,729 )
( 428,186 )
CASH FLOWS FROM INVESTING ACTIVITIES
Shareholder Loan Repayment
—
1,145
Net cash provided by investing activities
—
1,145
CASH FLOWS FROM FINANCING ACTIVITIES
Deferred Offering Costs
( 148,022 )
( 164,225 )
Short-Term Loan
100,000
—
Net Proceeds from Convertible Debt A, B, C, D, E & F
751,000
775,000
Net cash provided by financing activities
702,978
610,775
Net change in cash
61,249
183,734
Cash – beginning of period
38,982
171,480
Cash – end of period
$ 100,231
355,214
Cash paid for interest
$ —
—
NON CASH INVESTING AND FINANCING ACTIVITIES
Discount on Notes Payable – redemption premium
475,500
350,000
Dividends Payable
31,250
31,250
Deferred offering costs recorded as accounts payable
42,266
95,340
Conversion of Make-Whole Liability to Common Stock & APIC
—
700,000
The
accompanying notes are an integral part of these unaudited financial statements.
4
OS
Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
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 March 31, 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 March 31, 2024, the Company had cash of $ 100,231 . 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 March 31, 2024 and December 31, 2023, Chase Bank Checking account had $ 5,144
and $ 88 respectively. As of March 31, 2024 and December 31, 2023, SVB Bank Checking account had $ 95,087 and $ 38,894 respectively. There
were no accounts in excess of the FDIC limits.
5
OS
Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
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 three
months ended March 31, 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 Proposed Public Offering and that will be charged to stockholders’ equity upon the completion of the
Proposed Public Offering. Should the Proposed Public Offering prove to be unsuccessful, these deferred costs, as well as additional expenses
incurred, will be charged to operations. At March 31, 2024, the Company had $ 941,338 in capitalized deferred offering costs. At December
31, 2023, the Company had $ 751,050 in capitalized deferred offering costs.
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.
6
OS
Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
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.
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 March 31, 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 dilutive 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.
7
OS
Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
NOTE
2 — SIGNIFICANT ACCOUNTING POLICIES (cont.)
Below
is a table listing all preferred stock and common stock equivalents:
Common Stock Equivalents
March 31, 2024
(unaudited)
December 31,
2023
Convertible Debt
$ 11,559,098
$ 11,034,773
Make-Whole Liability
65,000
65,000
Warrants
605,689
604,281
Preferred Stock
—
1,302,082
Total
$ 12,229,787
$ 13,006,136
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 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
March 31, 2024 and December 31, 2023, the Company had a payroll payable to the CEO of $ 330,000 and $ 300,000 , respectively, and related
payroll taxes payable of $ 9,224 and $ 7,830 , respectively. During the period ending March 31, 2024 and December 31, 2023 the company made
advances on the payroll payable and the CEO made repayments.
8
OS
Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
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
80,350
Repayment
( 5,000 )
Balance March 31, 2024
$ 266,548
In
the second quarter of 2024, a bonus check was issued to Paul Romness, CEO. The bonus paycheck is comprised of the remaining balance of
backpay, less all 2023 payroll advances. The payroll taxes were paid that were associated with the back pay and as of April 29, 2024
the back pay, related payroll taxes and associated payroll advances are fully paid.
Related
Parties — Convertible Debt
Of
the total outstanding notes at March 31, 2024, 8.67 % of Group A and 4.55 % of Group E are held by related parties.
Ted
Search and John Ciccio, collectively known as Mill River Partners LLC, are members of the Board and hold convertible notes with face
amounts of $ 150,000 and $ 150,000 as of March 31, 2024 and December 31, 2023, respectively.
Related
Party Accounting Fees
The
company has a bill in accounts payable of $ 58,100 for the period ended March 31, 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 Christopher Acevedo,
the Company’s 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.
Group
Rate
Maturity
Collateral
Conversion
Rate
March 31,
2024
Carrying
Amount
December 31,
2023
Carrying
Amount
A
10 %
10/31/2024
None
80 % – 87.5 %
$ 1,153,383
$ 1,151,032
B
6 %
10/31/2024
None
80 %
$ 5,154,000
$ 5,154,000
C
6 %
10/31/2024
None
80 %
$ 3,945,020
$ 3,873,417
D
6 %
10/31/2024
None
50 %
$ 2,000,000
$ 1,950,160
E
6 %
10/31/2024
None
50 %
$ 1,100,000
$ 1,100,000
F
6 %
10/31/2024
None
50 %
$ 2,112,174
$ 1,381,732
Blink Bio
10 %
3/15/2022
None
100 %
$ —
$ —
9
OS
Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
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 and 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.
The
convertible debt balance at March 31, 2024 and December 31, 2023 is summarized as follows:
Debt A
As of
March 31,
2024
As of
December 31,
2023
Principal amount outstanding
$ 1,154,000
$ 1,154,000
Less: discounts (issuance, redemptions)
( 185,224 )
( 185,224 )
Amortization of discounts
184,607
182,256
Carrying value
1,153,383
1,151,032
Less Related Party Portion
( 100,000 )
( 100,000 )
Convertible Notes – A
$ 1,053,383
$ 1,051,032
10
OS
Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
NOTE
4 — CONVERTIBLE DEBT (cont.)
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. No such Next Equity Financing has occurred through March 31, 2024. 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.
The
convertible debt balance at March 31, 2024 and December 31, 2023 is summarized as follows:
Debt B
As of
March 31,
2024
As of
December 31,
2023
Principal amount outstanding
$ 5,154,000
$ 5,154,000
Less: discounts (issuance, redemptions, warrants)
( 1,818,939 )
( 1,818,939 )
Amortization of discounts
1,818,939
1,818,939
Carrying value
$ 5,154,000
$ 5,154,000
11
OS
Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
NOTE
4 — CONVERTIBLE DEBT (cont.)
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. No such Next Equity Financing has occurred through March 31, 2024. 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.
The
convertible debt balance at March 31, 2024 and December 31, 2023 is summarized as follows:
Debt C
As of
March 31,
2024
As of
December 31,
2023
Principal amount outstanding
$ 3,945,020
$ 3,945,020
Less: discounts (issuance, redemptions, warrants)
( 1,088,223 )
( 1,063,223 )
Amortization of discounts
1,088,223
1,016,620
Carrying value
$ 3,945,020
$ 3,873,417
12
OS
Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
NOTE
4 — CONVERTIBLE DEBT (cont.)
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. No such Next Equity Financing has occurred through March 31, 2024. 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 as of March 31,
2024 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.
The
convertible debt balance at March 31, 2024 and December 31, 2023 is summarized as follows:
Debt D
As of
March 31,
2024
As of
December 31,
2023
Principal amount outstanding
$ 2,000,000
$ 2,000,000
Less: discounts (issuance, redemptions, warrants)
( 1,864,654 )
( 1,864,654 )
Amortization of discounts
1,864,654
1,814,814
Carrying value
$ 2,000,000
$ 1,950,160
13
OS
Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
NOTE
4 — CONVERTIBLE DEBT (cont.)
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. No such Next Equity Financing has occurred through March 31, 2024. 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 as of March 31,
2024 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.
The
convertible debt balance at March 31, 2024 and December 31, 2023 is summarized as follows:
Debt E
As of
March 31,
2024
As of
December 31,
2023
Principal amount outstanding
$ 1,100,000
$ 1,100,000
Less: discounts (issuance, redemptions, warrants)
( 550,000 )
( 550,000 )
Amortization of discounts
550,000
550,000
Carrying value
1,100,000
1,100,000
Less related party portion
( 50,000 )
( 50,000 )
Convertible Notes – E
$ 1,050,000
$ 1,050,000
14
OS
Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
NOTE
4 — CONVERTIBLE DEBT (cont.)
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. No such Next Equity Financing has occurred through March 31, 2024. 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 536,700 shares of common stock as of March 31,
2024 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.
The
convertible debt balance at March 31, 2024 and December 31, 2023 is summarized as follows:
Debt F
As of
March 31,
2024
As of
December 31,
2023
Principal amount outstanding
$ 2,683,500
$ 1,932,500
Less: discounts (issuance, redemptions, warrants)
( 1,391,750 )
( 966,250 )
Amortization of discounts
820,424
415,482
Carrying value
$ 2,112,174
$ 1,381,732
15
OS Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
NOTE 4 — CONVERTIBLE DEBT
(cont.)
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 March 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 $ 475,500 and $ 1,541,250 for the periods
ended March 31, 2024 and December 31, 2023, respectively. The redemption liability is re-measured at each period end and is summarized
as follows:
As of
March 31,
2024
As of
December 31,
2023
New Embedded Redemption Value – Group A
144,250
144,250
New Embedded Redemption Value – Group B
1,130,800
1,130,800
New Embedded Redemption Value – Group C
789,004
789,004
New Embedded Redemption Value – Group D
1,000,000
1,000,000
New Embedded Redemption Value – Group E
550,000
550,000
New Embedded Redemption Value – Group F
1,441,750
966,250
Ending Balance
$ 5,055,804
$ 4,580,304
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
March 31,
2024
As of
December 31,
2023
Debt Issuance Costs
Group A
$ —
$ —
Group B
—
—
Group C
—
9,133
Group D
—
—
Total Net Debt Issuance
$ —
$ 9,133
16
OS Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
NOTE 4 — CONVERTIBLE DEBT
(cont.)
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 owing an aggregate of 466,404 shares valued in the amount of $ 408,413 , after issuing
400,000 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 141,248 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 three months ended
March 31, 2024 and 2023, the Company recorded an additional 0 and 33,344 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.
Make-whole liability — Shares Officers
& Directors
In January 2023, 700,000 shares
of Class A common stock were issued to officers, key employees, key advisors and directors, leaving 40,000 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 25,000 shares of common stock with a value
of $ 2.00 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 will be awarded the balance of Mr. Musso’s shares upon a successful
initial public offering.
The Company’s make-whole
share liability is summarized in the table below as of March 31, 2024.
Name
Position
# Shares
Value
Date Earned
Alan Musso
Former CFO
6,250
$ 12,500
March 1, 2023
Christopher Acevedo
Current CFO
18,750
37,500
Upon IPO
Joacim Borg
Director
40,000
80,000
July 1, 2022
TOTAL
65,000
$ 130,000
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 in the three months ending March
31, 2024.
17
OS Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
NOTE 4 — CONVERTIBLE DEBT
(cont.)
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 three months ended March 31, 2024 and 2023 was $ 49,840 and $ 83,069 , respectively.
The total unamortized discount of those warrants is $ 0 and $ 49,840 as of March 31, 2024 and December 31, 2023, respectively.
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. The company intends
to repay the loan in 2024.
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.
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 three months ended
March 31, 2024, no payments were made.
18
OS Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
NOTE 6 — COMMITMENTS AND CONTINGENCIES
(cont.)
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
All milestone payments are
non-creditable and non-refundable and are 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 three
months ended March 31, 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
19
OS Therapies Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
NOTE 6 — COMMITMENTS AND CONTINGENCIES
(cont.)
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 three months ended March 31, 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.
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 three months ended March 31, 2024 and year ended December 31,
2023, we paid $ 86,687 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 March 31, 2024, the balance
due to George Clinical was $ 644,287 .
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.
20
OS Therapies
Incorporated
Notes to the Unaudited Financial Statements
For the Three Months Ended March 31, 2024 and 2023
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 March 31, 2024 and December 31, 2023, the Company had
11,982,082 and 10,680,000 shares of Common Stock outstanding, respectively. Common Stock has voting rights .
Preferred Stock
In 2021, 5,000,000 shares of
Preferred Stock were authorized, 1,400,000 was 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 1:1 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 three
months ended March 31, 2024 and the year ended December 31, 2023 was $ 31,250 and $ 125,000 , respectively, for a total accrued dividend
payable at March 31, 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.
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
March 31,
2024
Total, as of
December 31,
2023
Shares Issued to Investors
—
1,302,082
Total Shares Issued
—
1,302,082
NOTE 8 — SUBSEQUENT EVENTS
The Company has issued $ 0.75
million in Group F Convertible Notes (see Note 4) through April 22, 2024. These notes carry a 6 % interest rate and mature on October 31,
2024 .
21
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 Statement
on Form S-1 initially filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2023, 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 recurrence
rates. We are currently seeking to answer the call for new treatments with our lead core product candidate OST-HER2 (also known as OST31-164).
We intend to expand our pipeline beyond Osteosarcoma with this product candidate into other solid tumors with the same recurrence mechanism
of action, including breast, esophageal and lung cancers. With the addition of our OST-Tunable Drug Conjugate (OST-tADC) platform, which
we consider to be a next generation antibody-drug conjugate (ADC) technology, we will be targeting ovarian, lung and pancreatic cancers.
Furthering our founding mission, we also intend to investigate clinical indications for OST-tADC in Osteosarcoma.
22
We believe that there have not been any new treatments
approved by the U.S. Food and Drug Administration (FDA) for 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.
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.
We have built a pipeline of product candidates
targeting multiple indications for solid cancers. Our pipeline includes two drug technologies: (i) OST-HER2, an off-the-shelf immunotherapy,
which is a type of cancer treatment that helps one’s immune system fight cancer, comprised of a genetically weakened and modified
strain of Listeria monocytogenes , a species of bacteria that causes the infection listeriosis, that expresses HER2 peptides, and
(ii) OST-tADC, a next generation tunable ADC with a plug-and-play platform that features tunable pH sensitive silicone linkers
(SiLinkers). The payloads can include antibodies, chemotherapeutics, cytotoxins and potentially mRNA treatments directly into and in the
vicinity of solid tumors.
Our Technology Platform
We are in the process of building a fully integrated
platform technology to accelerate the development of a range of product candidates across multiple therapeutic areas. Our platform technology
is intended to leverage our management’s in-depth experience in immunotherapy research, development and manufacturing to enable
us to pursue multiple therapeutic targets. Our scientists and scientific advisors have accumulated decades of collective experience in
the field of immunotherapy, oncology and small-molecule drug production, contributing key insights and significant achievement in our
clinical development process.
Our Core Values
Our company’s three core values are:
● Patient Impact. We care
deeply about what we are building to change the future for patients. We are developing therapies for significant unmet medical need.
● Empowerment. We are all
responsible for delivering on our mission to develop new medicines for patients: listen, speak up and engage.
● Collaboration. We know
that we are better together and thrive when we challenge each other to find a better way for patients.
Our Growth Strategies
Our goal is to enrich and lengthen the lives of
patients by being a leading, fully integrated biotechnology company. We are seeking to develop, manufacture and commercialize multiple
product candidates targeting orphan and non-orphan oncologic diseases across multiple tissue types and therapeutic areas. To achieve our
goal, we are pursuing the following growth strategies:
● Consider potentially out-licensing OST-HER2 to animal health
companies for veterinary use to treat dogs diagnosed with Osteosarcoma, one year of age or older.
● Obtain marketing approval for OST-HER2 in Osteosarcoma, then
quickly pivot to a master protocol within breast, esophageal, lung and other solid tumors where metastases express HER2 that could be
targeted by immune cells.
23
● Conclude pre-clinical and toxicology trials with the lead drug
candidate for OST-tADC (OST-tADC-A, Exatecan-silanol-FRa), and file for an investigational new drug application (IND) to initiate a Phase I
trial in ovarian cancer and other folate receptor alpha overexpressing cancers like endometrial cancer and some osteosarcomas. We believe
that positive results from preclinical two-week and good laboratory practice (GLP) toxicology studies may also stimulate potential out-licensing
activity of SiLinker and CAPs drug products, while not limiting therapeutic development.
● Establish global commercial and medical affairs capabilities
for OST-HER2 based therapies.
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, since we have not entered into a priced equity round through March 31, 2024. 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 $475,000 and $1,541,250 for the periods ended March 31, 2024 and December 31, 2023, respectively.
24
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.
Components of Our Results of Operations
Revenue. We
did not recognize revenues for the three months ended March 31, 2024 or the years ended December 31, 2023 and 2022.
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.
25
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 March 31, 2024 and 2023 was $375,000 and $250,000, respectively.
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 March 31, 2024 Compared
to Three Months Ended March 31, 2023
The following table summarizes our results of
operations for the three months ended March 31, 2024 and 2023:
March 31,
(In thousands)
2024
2023
Expenses:
Research and development expenses
$ 361,809
$ 753,784
General and administrative
268,423
294,247
Total operating expenses
630,232
1,048,031
Loss from operations
(630,232 )
(1,048,031 )
Other income (expenses):
Interest expense
(828,760 )
(798,938 )
Total other expenses
(828,760 )
(798,938 )
Net loss
(1,458,992 )
(1,846,969 )
Cumulative Series A preferred stock dividend requirement
(31,250 )
(31,250 )
Net loss available to common shareholders
$ (1,490,242 )
$ (1,878,219 )
26
Research and Development Expenses. Research
and development expenses were approximately $0.4 million for the three months ended March 31, 2024 compared to approximately
$0.8 million for the three months ended March 31, 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 March 31, 2024 and 2023:
As of March 31,
(In thousands)
2024
2023
Direct research and development expenses by program:
OST-HER2
$ 253
$ 500
OST-tADC
—
153
Unallocated research and development expenses:
Personnel-related
109
101
Total research and development expenses
$ 362
$ 754
For the three months ended March 31, 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 $0.3 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 three months ended March 31, 2024 and 2023, respectively.
General and Administrative Expenses. General
and administrative expenses for the three months ended March 31, 2024 were approximately $0.3 million compared to $0.3 million
for the three months ended March 31, 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 March 31, 2024 and 2023.
Interest Expense. Interest
expense for the three months ended March 31, 2024 was approximately $0.8 million compared to $0.8 million for the three
months ended March 31, 2023. to 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 three months ended March 31, 2024 and 2023, we reported a net loss of
approximately $1.5 million and $1.8 million, respectively, and had an accumulated deficit of approximately $31.0 million and $23.5 million,
respectively. We expect to incur significant expenses at an increasing rate and increasing operating losses for the foreseeable future.
As of March 31, 2024 and 2023, we had cash of
approximately $0.1 million and $0.4 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 $17.9 million as of March 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 six months.
27
Cash Flows
The following table summarizes our sources and
uses of cash for each of the periods presented:
March 31,
(In thousands)
2024
2023
Cash used in operating activities
$ (642 )
$ (428 )
Cash provided by investing activities
—
1
Cash provided by financing activities
703
611
Net increase (decrease) in cash
$ 61
$ 184
Operating Activities
During the three months ended March 31, 2024 and
2023, operating activities used approximately $0.6 million and $0.4 million of cash, respectively, resulting from our net loss of
approximately $1.5 million and $1.8 million, respectively, offset by net non-cash charges of approximately $0.6 million and $0.7 million,
respectively, partially offset by net cash provided by changes in our operating assets and liabilities of approximately $0.2 million and
$0.7 million, respectively.
Net cash provided by changes in our operating
assets and liabilities for the three months ended March 31, 2024 and 2023 consisted primarily of an increase in accounts payable of approximately
$0.04 million and $0.4 million, respectively, an increase in accrued interest of approximately $0.3 million and $0.2 million,
respectively, and a change in accrued payroll of approximately $(0.1) million and $0.0 million, respectively.
Non-cash charges for the three months ended March
31, 2024 and 2023 were primarily the result of the amortization of debt discount on our convertible debt of approximately $0.6 million
and $0.6 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 three months ended March 31, 2024 and
2023, net cash provided by investing activities was approximately $0.0 million and $0.0 million, respectively.
Financing Activities
During the three months ended March 31, 2024 and
2023, net cash provided by financing activities was approximately $0.7 million and $0.6 million, respectively. The net cash provided
by financing activities for the three months ended March 31, 2024 and 2023 consisted primarily of net proceeds from sales of convertible
notes, 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.
28
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
March 31,
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
$ 1.2
$ 5 to 25 – varies per note
B
2020 – 2021
6 %
10/31/2024
None
80 %
$ 5.2
$ 5.2
$ 19
C
2021 – 2023
6 %
10/31/2024
None
80 %
$ 3.9
$ 3.9
$19 or
50 – varies per note
D
2022 – 2023
6 %
10/31/2024
None
50 %
$ 2.0
$ 2.0
$ 50
E
2023
6 %
10/31/2024
None
50 %
$ 1.1
$ 1.1
$ 50
F
2023 – 2024
6 %
10/31/2024
None
50 %
$ 2.1
$ 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 $2.3 million and $2.0 million as of March 31, 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.
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 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 on the Group A Convertible
Notes are 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 is our anticipated initial public offering). In general, the stated
Maturity Date varies 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 will automatically
convert into shares of our common stock upon the consummation of our anticipated initial public offering. The number of shares of our
common stock that to be issued upon the automatic conversion will be 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 have conversion capitalization ceilings
that range from $5 million to $25 million, which limits the price a noteholder must pay in a convertible note-to-common stock
conversion occurrence. The Group A Convertible Notes will have a conversion price that ranges from $0.39 to $1.97 per share, depending
on the applicable valuation ceiling of each note (based on an assumed 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 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 are 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 is
our anticipated 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 will automatically
convert into shares of our common stock upon the consummation of our anticipated initial public offering. The number of shares of our
common stock that to be issued upon the automatic conversion will be 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 have a Conversion Capitalization ceiling of $19 million, which limits 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 will have a conversion price of $1.31 per share (based on an assumed initial public offering price of $4.00 per share).
29
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 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 are 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 is our anticipated initial public
offering). In general, the stated Maturity Date is May 31, 2024 but was extended in October 2023, under the same terms, until
October 31, 2024.
The Group C Convertible Notes will automatically
convert into shares of our common stock upon the consummation of our anticipated initial public offering. The number of shares of our
common stock that to be issued upon the automatic conversion will be 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 of our anticipated initial public offering by
80% of the initial public offering price per share in such offering. The Group C Convertible Notes have a conversion capitalization ceiling
of $50 million, except that one note is subject to a valuation ceiling of $19 million, which limits 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
will have a conversion price of $1.31 or $2.61 per share, as applicable (based on an assumed 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 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 are 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 is our anticipated initial public offering). In general, the
stated Maturity Date is October 31, 2024.
The Bridge Notes will automatically convert into
shares of our common stock upon the consummation of our anticipated initial public offering. The number of shares of our common stock
that to be issued upon the automatic conversion will be equal to the quotient obtained by dividing the outstanding principal and unpaid
accrued interest due on a Bridge Note on the date of conversion of our anticipated initial public offering by 50% of the initial public
offering price per share in such offering. The Bridge Notes have a conversion capitalization ceiling of $50 million, which limits
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 will have a conversion price of $2.00 per share (based on an assumed initial public offering price of $4.00 per share).
Demand Note. On
March 6, 2024, we issued a demand promissory note to a lender who was an investor in one of our prior convertible notes rounds in a principal
amount of $100,000. The demand note bears interest at a rate of 8% per annum and the principal plus all accrued interest is payable upon
demand by such lender. If such note is 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 the date of May 13, 2024, the lender has not demanded payment from us.
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 1,302,082 shares of common stock (on a pre-split basis).
30
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 March 31, 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.
31
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 March 31, 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 budget under the agreement is approximately
$2,436,928. For the three months ended March 31, 2024 and year ended December 31, 2023, we paid $86,687 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
32
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 March 31, 2024, the balance due to George Clinical
was $644,287.
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 anticipated 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
March 31, 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 quarter of 2024 that have materially affected, or are reasonably
likely to materially affect, the Company’s internal control over financial reporting.
33
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.
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. Although we deny that Noble is entitled to any such
shares, out of an abundance of caution, we will reserve for issuance 474,134 shares of our common stock until final disposition of the
arbitration. On June 7, 2024, there will be a hearing before a single emergency appointed arbitrator on Noble’s request for preliminary
injunctive relief. Thereafter, the parties will proceed with their selection of a three-arbitrator panel as agreed to in the advisory
agreement.
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. 333-271034), as amended, initial
filed with the SEC on March 31, 2023, 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
From November 2022 to April 2024, we
issued convertible notes in an aggregate principal amount of $6,533,500 (the “Bridge Notes”) to accredited investors in
exchange for cash in an aggregate amount of $6,533,500. The Bridge Notes bear interest at a rate of 6% per annum and mature on
October 31, 2024. The Bridge Notes automatically convert into common stock at 50% of the price per share in our Next Equity
Financing (which is our anticipated initial public offering), subject to a valuation ceiling of $50 million. The Bridge Notes will
have a conversion price of $2.00 per share (based on an assumed initial public offering price of $4.00 per share).
In connection with the Bridge Notes, we agreed
to issue an additional 653,350 shares of common stock (on a post-split basis) to the bridge investors, prorated based on such investor’s
investment amount, as an inducement for their investment in the Bridge Notes. Additionally, we issued to Noble Life Science Partners,
a division of Noble Capital Markets, Inc., the placement agent for the Group D placement, warrants to purchase 50,000 shares of common
stock at an exercise price of $2.00 per share (the “Group D Warrants”), based on an assumed initial public offering price
of $4.00 per share. The Group D Warrants may, at the option of the holder, be exercised in whole or part on a cashless basis. The
Group D Warrants expire five years after the effective date of our anticipated initial public offering.
The issuances described above were not registered
under the Securities Act in reliance upon the exemption from registration provided by Section 4(a)(2) thereof and Regulation D
promulgated thereunder, which exempts transactions by an issuer not involving any public offering. The recipients of securities in each
such transaction represented their intention to acquire the securities for investment only and not with a view to or for sale in connection
with any distribution thereof and appropriate legends were affixed to the share certificates and other instruments issued in such transactions.
All recipients either received adequate information about the registrant or had access, through employment or other relationships, to
such information.
34
Use of Proceeds
On March 31, 2023, we filed a Registration Statement
on Form S-1 (File No. 333-271034) (as amended, the “Registration Statement”), which was declared effective by the SEC on February
14, 2024. To date, no securities have been sold under the Registration Statement. On May 13, 2024, we filed a Post-Effective Amendment
No. 1 to the Registration Statement (the “Post-Effective Amendment”) to update certain information in the Registration Statement.
No additional securities are being registered under the Post-Effective Amendment. As of May 20, 2024, the SEC has not declared the Post-Effective
Amendment effective.
Item 6. Exhibits.
The following exhibits are filed with this Quarterly
Report on Form 10-Q:
Exhibit No.
Description
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 March 31, 2024, formatted in Inline XBRL: (i) Balance Sheets as of March 31, 2024 (unaudited)
and December 31, 2023; (ii) Statements of Operations for the three months ended March 31, 2024 and 2023 (unaudited); (iii) Statements
of Stockholders’ Deficit for the three months ended March 31, 2024 and 2023 (unaudited); (iv) Statements of Cash Flows for
the three months ended March 31, 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 March 31, 2024, formatted in Inline XBRL (included as Exhibit 101).
* Furnished herewith.
35
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: May 20, 2024
By:
/s/ Paul Romness
Paul Romness
Chief Executive Officer
(Principal Executive Officer)
Date: May 20, 2024
By:
/s/ Christopher Acevedo
Christopher Acevedo
Chief Financial Officer
(Principal Financial and Accounting Officer)
36
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.