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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
June 30, 2026
OS THERAPIES INCORPORATED
(Exact name of registrant as specified in its charter)
| Delaware |
|
001-42195 |
|
82-5118368 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
115 Pullman Crossing Road, Suite 103
Grasonville, Maryland |
|
21638 |
| (Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (410) 297-7793
N/A
(Former name or former address, if changed since
last report.)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class |
|
Trading Symbol(s) |
|
Name of Each Exchange on Which Registered |
| Common Stock, par value $0.001 per share |
|
OSTX |
|
NYSE American |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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.
CURRENT REPORT ON FORM 8-K
OS Therapies Incorporated
June 30, 2026
Item 1.01. Entry into a Material Definitive
Agreement.
On June 30, 2026, OS Therapies
Incorporated (the “Company”), together with OS Animal Health Inc. (“OSAH”) and OS Therapies UK Ltd (“OSUK”
and, collectively, the “Borrowers”), each a wholly owned subsidiary of the Company, entered into a securities purchase agreement
(the “Purchase Agreement”) with Leonite Fund I, LP (the “Investor”), pursuant to which the Company agreed to issue
and sell to the Investor, in a private placement (the “Private Placement”), a senior secured convertible promissory note in
an aggregate principal amount of up to $10,000,000 (the “Note”). As additional consideration for the Investor’s purchase
of the Note, the Company also agreed to issue to the Investor (i) 275,000 shares of the Company’s common stock (the “Commitment
Shares”) and (ii) a five-year warrant (the “Warrant”) to purchase up to 1,750,000 shares of the Company’s common
stock (the “Warrant Shares” and, collectively with the Note, Commitment Shares and Warrant, the “Securities”).
Securities Purchase Agreement
Pursuant to the Purchase Agreement,
the Investor agreed to purchase the Note in an aggregate principal amount of up to $10,000,000, to be funded in one or more tranches.
Each funded tranche is subject to an original issue discount of 7.5%, which is included in the principal balance and earned only upon
funding of such tranche. The first tranche of $1,600,000 (less $35,000 retained by the Investor for legal fees and expenses) is expected
to be funded on July 2, 2026. An additional $400,000 is to be funded within 14 days from the date the first tranche is funded, subject
to adequate collateral as determined by the Investor. The remainder is to be funded in additional tranches at the sole discretion of the
Investor.
The Company intends to use
the net proceeds of the Private Placement to fund clinical development and regulatory activities, as well as for working capital and other
general corporate purposes.
Pursuant to the Purchase Agreement,
the Company has agreed not to issue, upon conversion of the Note, exercise of the Warrant or otherwise, shares of its common stock in
excess of 19.99% of the shares of the Company’s common stock outstanding as of June 30, 2026 to the extent such issuance would require
stockholder approval under the applicable rules of the NYSE American, including Section 713 thereof, unless and until such stockholder
approval has been obtained (the “exchange cap”). The Company has agreed to seek any such required stockholder approval by
the earlier of (i) 90 calendar days following the Closing Date (as defined in the Purchase Agreement) and (ii) its next regularly scheduled
meeting of stockholders.
Pursuant to the Purchase Agreement,
the Company has also agreed to file a resale registration statement covering the resale of all shares of the Company’s common stock
issued or issuable pursuant to the transaction documents (including the Commitment Shares, Warrant Shares and any shares of common stock
issuable upon conversion of the Note) within 90 days following the Closing Date and to cause such registration statement to be declared
effective by the Securities and Exchange Commission (the “SEC”) within 180 days following the Closing Date.
The Purchase Agreement provides
the Investor with (i) a participation right, pursuant to which, during the period beginning on the issuance date of the Note and ending
on the later of (A) 18 months following the advance date of the most recent tranche and (B) the date the Note has been paid in full, the
Investor may participate in certain future offerings of the Company’s or its subsidiaries’ securities by purchasing securities
in an amount equal to up to 100% of the then-outstanding principal amount of the Note on the same terms and conditions offered to other
investors, (ii) a right of first refusal with respect to certain bona fide financing opportunities received by the Company or its subsidiaries
while the Note remains outstanding, pursuant to which the Company is required to offer such financing opportunities to the Investor on
the same terms as those proposed by third parties, and (iii) rollover rights, pursuant to which the Investor may elect, in connection
with certain future public or private offerings of the Company’s equity, equity-linked or debt securities, to apply all or a portion
of the then-outstanding principal amount of, and accrued but unpaid interest on, the Note, together with certain Company securities then
held by the Investor, as consideration for securities issued in such financing, in each case on the same terms as other participating
investors, and subject, in the case of clauses (ii) and (iii), to certain exceptions.
The Purchase Agreement also
provides that, for so long as any amounts remain outstanding under the Note, the Investor has a most-favored-nation right with respect
to future financings and certain amendments to existing securities, pursuant to which, if the Company or any subsidiary issues or proposes
to issue any securities, or amends or proposes to amend any outstanding securities, containing terms that are more favorable to the holders
of such securities than the terms provided to the Investor under the transaction documents (or terms not otherwise afforded to the Investor),
the Company is required to provide notice of such terms to the Investor and, at the Investor’s option, such more favorable terms
will be incorporated into the transaction documents, subject to certain exceptions.
Terms of the Note
The following summary of certain
terms and provisions of the Note is not complete and is subject to, and qualified in its entirety by, the provisions of the Note, the
form of which is filed as Exhibit 4.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Interest and Maturity
The Note bears interest at
a rate of 9.0% per annum, payable monthly in arrears. Interest accrues on each tranche from the date the applicable advance is funded
and is guaranteed for the full term of such tranche. Each tranche of the Note matures on the date that is nine months following the applicable
advance date; provided that no tranche may mature later than 24 months following the issue date of the Note.
Conversion and Conversion
Limitations
The Note is convertible, at
the holder’s option, at any time, in whole or in part, into shares of the Company’s common stock at an initial conversion
price of $2.05 per share, subject to adjustment as provided therein. Subject to the holder’s election, the conversion amount may
include outstanding principal, accrued and unpaid interest, default interest and certain other amounts payable under the Note. The holder’s
conversion rights are subject to a beneficial ownership limitation of 4.99% of the Company’s outstanding common stock, which limitation
may be increased to 9.99% upon prior notice from the holder (or immediately upon notice if the holder is not subject to the reporting
requirements of Section 13 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), as well as the exchange
cap and stockholder approval provisions set forth in the Note and the Purchase Agreement. Accordingly, the Company may not issue, and
the holder may not receive, shares upon conversion of the Note to the extent such issuance would exceed the applicable exchange cap or
otherwise require stockholder approval under the applicable rules of the principal national securities exchange on which the Company’s
common stock is then listed, unless and until such stockholder approval has been obtained.
Conversion Price Adjustments
While the Note is outstanding,
the conversion price is subject to customary adjustments for stock splits, stock dividends, recapitalizations, reclassifications and similar
transactions. In addition, if the Company issues or sells, or grants or amends securities that are convertible into, exercisable for or
otherwise entitle the holders thereof to acquire shares of the Company’s common stock at an effective price per share below the
then-applicable conversion price, subject to certain exceptions, the conversion price will be reduced to such lower effective price. However,
no such adjustment will become effective on or prior to September 29, 2026. Any adjustment resulting from a dilutive issuance occurring
on or prior to September 29, 2026 will be determined as of the date of such issuance in accordance with the terms of the Note, but will
automatically become effective on September 30, 2026, without any further action by the parties. For purposes of such adjustment, securities
containing price reset, floating conversion or exercise price, ratchet or similar price protection features will be deemed to have been
issued at the lowest effective price resulting from such features. The anti-dilution adjustment is subject to certain exceptions, including
certain exempt issuances, sales pursuant to the Company’s at-the-market offering program, and certain qualifying registered public
offerings. In addition, a qualifying registered public offering will not trigger the anti-dilution adjustment if the Company receives
at least $5.0 million in gross proceeds in a single closing and prepays the Note in full with the proceeds of such offering, and the Company
may effect such prepayment without complying with the otherwise applicable 30-day prior notice requirement.
Prepayment
The Company may prepay the
Note, in whole or in part, prior to its maturity upon at least 30 days’ prior written notice to the holder, by paying an amount
equal to 110% of the principal amount being prepaid, together with all accrued and unpaid interest thereon and any other amounts then
due under the Note. The holder has the right to convert the Note during the 30-day notice period, and if the Company does not complete
the prepayment on the date specified in the notice, the prepayment election will be void and the holder’s conversion rights will
be reinstated.
Events of Default
The Note contains customary
events of default, including, among others, failure to pay principal or interest when due, failure to reserve or deliver shares issuable
upon conversion of the Note, breaches of covenants, representations or warranties, certain monetary judgments or settlements, bankruptcy
or insolvency events, change of control, cessation of operations, material adverse effects relating to the Company’s assets or intellectual
property, financial statement restatements, delisting of the Company’s common stock, failure to maintain compliance with reporting
requirements under the Exchange Act, failure to obtain required stockholder approval and certain other specified corporate or financing-related
events.
Upon the occurrence and during
the continuation of an event of default, the outstanding obligations under the Note become immediately due and payable at an amount equal
to 125% of the then-outstanding obligations, interest accrues at a rate equal to the lesser of 24% per annum or the maximum rate permitted
by applicable law, and the Company is required to pay a monthly monitoring fee of $10,000 until such event of default is cured or waived.
In addition, during the continuation of an event of default, the holder has certain customary enforcement rights and remedies under the
Note and applicable law.
Negative Covenants
So long as any amounts remain
outstanding under the Note, the Company is subject to customary negative covenants, including limitations on the payment of dividends
or other distributions on its common stock, subject to limited exceptions for dividends payable solely in common stock and certain spin-off
or similar separation transactions approved by the Company’s board of directors.
The Company is also restricted
from entering into or amending any agreement involving a variable rate transaction, including any issuance of convertible securities with
conversion or exercise prices that are based on or fluctuate with the trading price of the Company’s common stock or that are subject
to reset or similar adjustment features, as well as certain equity line of credit or similar arrangements, subject to certain exceptions.
In addition, the Company is
subject to customary operating restrictions, including limitations on engaging in certain transactions outside the ordinary course of
business, changing its primary business, entering into specified high-cost or predatory financing arrangements or effecting certain structured
equity transactions, in each case without the prior consent of the holder. The Company is further restricted from redeeming, repurchasing
or otherwise acquiring its equity securities, subject to certain exceptions.
In addition, the Company is
required to apply proceeds from certain future financings and other specified receipts, including proceeds from future debt and equity
financings and certain other non-operating cash receipts, to the repayment of outstanding obligations under the Note, subject to certain
exceptions, including equipment financings and certain secured transactions permitted under the Note.
Security Interest
The Note is secured by a continuing first-priority security interest
in substantially all of the Company’s and its subsidiaries’ existing and after-acquired assets, subject to certain exclusions,
including intellectual property assets. Notwithstanding such exclusions, the security interest includes accounts, payment intangibles
and other rights to payment arising from the sale, license or other disposition of intellectual property. The security interests are memorialized
in a pledge and security agreement, which is filed as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Terms of the Warrant
The following summary of certain
terms and provisions of the Warrant is not complete and is subject to, and qualified in its entirety by, the provisions of the Warrant,
the form of which is filed as Exhibit 4.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Duration and Exercise Price
The Warrant has an initial
exercise price of $2.85 per share, subject to adjustment as provided therein, and is exercisable in whole or in part at any time from
the issuance date through June 30, 2031. The Warrant may be exercised for cash or, in certain circumstances, on a cashless basis.
Exercise Price and Warrant
Share Adjustments
The Warrant is subject to
customary adjustments to the exercise price and number of Warrant Shares for stock splits, stock dividends, recapitalizations, reclassifications
and similar transactions affecting the Company’s common stock.
In addition, if the Company
issues or sells, or is deemed to issue, securities (or amends existing securities) that are convertible into, exercisable for, or otherwise
entitle the holder thereof to acquire shares of the Company’s common stock at an effective price per share below the then-applicable
exercise price, subject to certain exceptions, the exercise price will be reduced to such lower effective price, and the number of Warrant
Shares will be increased proportionately so that the aggregate exercise price remains unchanged. However, no such adjustment will become
effective on or prior to September 29, 2026. Any adjustment resulting from a Dilutive Issuance occurring on or prior to September 29,
2026 will be determined as of the date of such Dilutive Issuance in accordance with the terms of the Warrant, but will automatically become
effective on September 30, 2026, without any further action by the parties. For purposes of such adjustment, securities containing price
reset, floating conversion or exercise prices, ratchet provisions or similar price protection features will be deemed to have been issued
at the lowest effective price that could result from the application of such features. The anti-dilution adjustment is subject to certain
exceptions, including sales pursuant to the Company’s at-the-market offering program, certain exempt issuances and qualifying registered
public offerings meeting specified size and structural requirements, provided the Note has been repaid in full.
Exercisability
The Warrant is exercisable,
at the option of the holder, in whole or in part, by delivering to the Company a duly executed exercise notice accompanied by payment
in full for the number of shares of the Company’s common stock purchased upon such exercise (except in the case of a cashless exercise
as discussed below). The holder may not exercise the Warrant to the extent that, after giving effect to such exercise, the holder and
its affiliates would beneficially own in excess of 4.99% of the Company’s outstanding common stock immediately following such exercise.
The holder may increase or decrease this limitation upon at least 61 days’ prior written notice to the Company, provided that the
limitation may not exceed 9.99% of the Company’s outstanding common stock.
The Warrant is also subject
to customary exchange cap and stockholder approval limitations, such that the Company may not issue shares upon exercise to the extent
such issuance would exceed the applicable exchange cap under the rules of the principal trading market, unless and until required stockholder
approval is obtained.
Cashless Exercise
The Warrant permits cashless
exercise in certain circumstances following the six-month anniversary of the issuance date. If the market price of the Company’s
common stock exceeds the exercise price and the shares issuable upon exercise are not then registered under an effective registration
statement, the holder may elect to exercise on a cashless basis in lieu of paying the exercise price in cash. In such case, the holder
will receive a number of shares determined pursuant to the formula set forth in the Warrant.
Rights as a Stockholder
Except as otherwise provided
in the Warrant or by virtue of the holder’s ownership of shares of the Company’s common stock, the holder of the Warrant does
not have the rights or privileges of a holder of the Company’s common stock, including any voting rights, until the holder exercises
the Warrant.
Fundamental Transactions
If, while the Warrant remains
outstanding, the Company enters into a fundamental transaction (including a merger in which the Company is not the surviving entity, a
sale of all or substantially all of its assets, a tender or exchange offer accepted by a majority of holders of the Company’s common
stock, or a reclassification or compulsory share exchange in which the common stock is converted into other securities, cash or property),
then upon any subsequent exercise of the Warrant, the holder will be entitled to receive the same number and type of securities, cash
or other property that a holder of the number of shares of common stock issuable upon exercise of the Warrant immediately prior to such
transaction would have been entitled to receive.
In addition, the exercise
price will be appropriately adjusted to reflect any such consideration, and if holders of common stock are given a choice of consideration
in the fundamental transaction, the holder will be entitled to the same choice upon exercise. If necessary to give effect to the foregoing,
the successor entity will issue a replacement warrant reflecting the applicable successor securities or consideration.
Waivers and Amendments
The terms of the Warrant may
be amended or waived only by written agreement of both the Company and the holder. Any such amendment or waiver may apply generally or
in a specific instance and may be effective on either a retroactive or prospective basis.
The foregoing descriptions
of the Purchase Agreement, the Note and the Warrant do not purport to be complete and are qualified in their entirety by reference to
the full text of such documents, which are filed as Exhibits 10.1, 4.1 and 4.2, respectively, to this Current Report on Form 8-K, and
are incorporated herein by reference.
In connection with the Private
Placement, OSUK assigned to the Investor all right, title and interest in certain assets, including all value added tax (“VAT”)
repayments, credits and refunds due or to become due from HM Revenue & Customs, and all research and development (“R&D”)
tax relief claims, credits, repayments and refunds due or to become due from HM Revenue & Customs. Such assignment covers the full
actual amounts of such VAT refunds and R&D tax relief claims, including all related rights to payment.
The Purchase Agreement contains
customary representations, warranties and covenants by the Company which were made only for the purposes of the Purchase Agreement and
as of specific dates, were solely for the benefit of the parties to the Purchase Agreement and may be subject to limitations agreed upon
by the contracting parties. Accordingly, the Purchase Agreement is incorporated herein by reference only to provide investors with information
regarding the terms of the Purchase Agreement and not to provide investors with any other factual information regarding the Company or
its business, and should be read in conjunction with the disclosures in the Company’s reports and other filings with the SEC.
This Current Report on Form
8-K does not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any
state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the
securities laws of any such state or jurisdiction.
Item 2.03. Creation of a Direct Financial Obligation
or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.
The information set forth
under Item 1.01 of this Current Report on Form 8-K is hereby incorporated by reference into this Item 2.03.
Item 3.02. Unregistered Sales of Equity Securities.
The information contained
in Item 1.01 of this Current Report on Form 8-K is hereby incorporated by reference into this Item 3.02. The Securities are being offered
and sold by the Company in reliance upon an exemption from the registration requirements of the Securities Act of 1933, as amended (the
“Securities Act”), afforded by Section 4(a)(2) thereof and/or Regulation D promulgated thereunder. The Investor represented
that it is an “accredited investor” as defined in Rule 501(a) under the Securities Act.
Item 5.02. Departure of Directors or Certain
Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On June 1, 2026, Karim Galzahr
notified the Company of his resignation from the Company’s board of directors, effective immediately. Mr. Galzahr’s resignation
was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
On June 1, 2026, the Company’s
board of directors appointed Dr. Craig Eagle to the board of directors to fill the vacancy created by Mr. Galzahr’s resignation,
effective immediately. Dr. Eagle currently serves in an advisory capacity to the Company as its Chief Medical Advisor.
Dr. Eagle has served as Chief
Medical Officer of Guardant Health, Inc. (Nasdaq: GH) since May 2021. From 2019 to May 2021, he served as Vice President, Medical Affairs
Oncology at Genentech, where he was responsible for medical programs across the oncology portfolio and supported the development of clinical
trial strategies in personalized medicine. Prior to Genentech, Dr. Eagle spent approximately 10 years at Pfizer Inc. in a series of senior
leadership roles, including Oncology Business Lead for the United Kingdom and Canada, Global Lead for Oncology Strategic Alliances and
Partnerships, and Global Head of the Oncology Therapeutic Area Global Medical and Outcomes Group, where he also oversaw the U.S. oncology
business. Dr. Eagle received his medical degree from the University of New South Wales in Sydney, Australia and completed his internal
medicine training at Royal North Shore Hospital in Sydney.
There are no family relationships
between Dr. Eagle and any director or executive officer of the Company that would be required to be disclosed pursuant to Item 401(d)
of Regulation S-K. In addition, there are no transactions between Dr. Eagle and the Company that would be required to be disclosed pursuant
to Item 404(a) of Regulation S-K.
Dr. Eagle has not entered
into any compensatory arrangement with the Company in connection with his appointment to the Board other than the standard compensation
arrangements applicable to non-employee directors.
Item 8.01 Other Events.
On July 2, 2026, the Company
issued a press release announcing the Private Placement and the appointment of Dr. Eagle to the Company’s board of directors, a
copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Forward-Looking Statements
This Current Report on Form
8-K, including Exhibit 99.1 hereto, contains forward-looking statements that involve risks and uncertainties, such as statements related
to the intended use of the net proceeds from the Private Placement. The risks and uncertainties involved include the Company’s financial
position, market conditions and other risks detailed from time to time in the Company’s periodic reports and other filings with
the SEC. You are cautioned not to place undue reliance on forward-looking statements, which are based on the Company’s current expectations
and assumptions and speak only as of the date of this Current Report on Form 8-K. The Company does not intend to revise or update any
forward-looking statement in this Current Report on Form 8-K as a result of new information, future events or otherwise, except as required
by U.S. federal securities law.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number |
|
Description |
| 4.1* |
|
Form of Senior Secured Convertible Promissory Note. |
| 4.2 |
|
Form of Common Stock Purchase Warrant. |
| 10.1* |
|
Securities Purchase Agreement, dated as of June 30, 2026, among OS Therapies Incorporated, OS Animal Health Inc., OS Therapies UK LTD and Leonite Fund I, LP. |
| 10.2 |
|
Pledge and Security Agreement, dated as of June 30, 2026, among OS Therapies Incorporated, OS Animal Health Inc., OS Therapies UK LTD and Leonite Fund I, LP. |
| 99.1 |
|
Press Release issued by OS Therapies Incorporated on July 2, 2026. |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
| * | Pursuant to Item 601(a)(5) of Regulation S-K, certain schedules
and exhibits have been omitted. The registrant agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC
upon its request. |
SIGNATURE
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 hereunto
duly authorized.
| |
OS THERAPIES INCORPORATED |
| |
|
| Dated: July 2, 2026 |
By: |
/s/ Paul A. Romness, MPH |
| |
|
Name: |
Paul A. Romness, MPH |
| |
|
Title: |
President and Chief Executive Officer |
Exhibit 99.1
OS
Therapies Appoints Dr. Craig Eagle to Board of Directors
| ● | Company
secures $10 million line of credit supported by OS Therapies UK tax credits |
New
York, NY and Rockville, MD, July 2, 2026 – OS Therapies, Inc. (NYSE American: OSTX) (“OS Therapies” or “the Company”),
the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced that it has appointed Dr. Craig Eagle to the
Company’s Board of Directors. Dr. Eagle currently serves as the Company’s Chief Medical Advisor. The Company also announced
that Karim Galzahr has stepped down from its Board of Directors.
“Having
enjoyed participating in recent U.S., European and U.K. regulatory meetings as we prepare for a late third quarter initiation of the
confirmatory Phase 3 study for OST-HER2 in the prevention or delay of recurrence of fully resected, pulmonary metastatic osteosarcoma,
we have now reached consensus on the vast majority of key items that pave the way for potential early market authorizations in late 2026,”
said Dr. Craig Eagle, Chief Medical Advisor and Board Member of OS Therapies. “The progress made on the sustained OST-HER2 overall
survival benefit compared with historical control at the 2.5-year timepoint, the unique biomarker signature that predicts that overall
survival benefit, as well as critical mass now having been reached in the recruitment into OST-400 all give me confidence as we prepare
for U.S. Food & Drug Administration (FDA) Type B Statistical Methods and, thereafter, Type B Pre-BLA meetings to gain full regulatory
alignment prior to completing the submission of our ongoing Biologics License Application submission under the Accelerated Approval Program.
We are hopeful for decisions on Rolling Review, Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations following
the Type B Statistical Methods Meeting.”
Dr.
Eagle most recently served as Guardant Health’s Chief Medical Officer. Prior to joining Guardant Health, Dr. Eagle served as Vice President
of Medical Affairs Oncology for Genentech, where he oversaw the medical programs across the oncology portfolio and developed innovative
cancer trials and strategies in personalized health care. Prior to Genentech, Dr. Eagle held several leadership roles at Pfizer, including
oncology business lead for the United Kingdom and Canada, global lead for Oncology Strategic Alliances and Partnerships, and global head
of the Oncology Therapeutic Area Global Medical and Outcomes Group, where he oversaw the U.S. oncology business. Dr. Eagle attended medical
school at the University of New South Wales in Sydney, Australia and received his general internist training at Royal North Shore Hospital
in Sydney.
“We
are thrilled to have Dr. Eagle join our Board of Directors as we look to transition from a development-stage company into a commercial
healthcare organization over the next year,” said Paul Romness, MPH, Chairman & CEO of OS Therapies.”
Concurrent
with this announcement, the Company announced that it entered into a $10 million line of credit (LOC) supported by the Company’s
wholly-owned subsidiary OS Therapies U.K. tax credits. The Company received an initial draw of $1.6 million that primarily supported
the second phase OST-HER2 commercial manufacturing following the receipt of global regulatory alignment on the commercial manufacturing
pathway for OST-HER2. OS Therapies UK currently has accumulated approximately $5.86 million in pending tax credit refunds and expects
to have accumulated a total of $10.2 million through year-end 2026. The Company did not provide security interest in its intellectual
property as part of the LOC agreements.
“With
a reliable way to monetize the significant R&D investments we made in the fourth quarter of 2025 and the first quarter in the U.K.
subsidiary, combined with significantly reduced expenses projected for the third quarter, the Company reiterates that it expects to have
sufficient cash and cash resources to provide runway into 2027,” said Chris Acevedo, CPA, Chief Financial Officer of OS Therapies.
OST-HER2
has received Orphan Drug Designation (ODD), Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) from the FDA,
and ODD, FTD and ATMP from the EMA. Under the RPDD program, if the Company receives a BLA in the United States, it will become eligible
to receive a Priority Review Voucher (PRV) that it intends to sell. The Company is seeking to obtain a BLA under the Accelerated Approval
Program for OST-HER2 in osteosarcoma by year-end 2026 in the U.S., in addition to conditional Marketing Authorisation Applications in
Europe, the U.K. and Australia.
About
OS Therapies
OS
Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma
(OS) and other solid tumors. The Company is the world leader in gene-edited, Listeria-based cancer immunotherapies. OST-HER2, the Company’s
lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting
the HER2 protein. OST-HER2 is designed to target two mutated extracellular epitopes and one mutated intracellular epitope of the HER2
oncogene, requiring only one of these three epitopes to be present in a tumor (or micro-metastasis) to trigger the desired immune response.
OST-HER2 has received Orphan Drug Designation (ODD), Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) from
the U.S. Food & Drug Administration and has received ODD, FTD and ATMP from the European Medicines Agency.
The
Company reported positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma,
demonstrating clinically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study and the overall
survival (OS) secondary endpoint. The Company is seeking a Biologics License Application (BLA) from the U.S. FDA for OST-HER2 in osteosarcoma
in 2026 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. The Company also anticipates
receiving Conditional Marketing Authorisation Applications from the U.K.’s Medicines and Healthcare products Regulatory Agency
and the EMA for OST-HER2 in 2026. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to
showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department
of Agriculture for the treatment of canines with osteosarcoma. The Company has also completed dosing in a Phase 1 study of OST-504 for
castration-resistant prostate cancer.
In
addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC
(tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company’s proprietary
silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more
information, please visit www.ostherapies.com.
Forward-Looking
Statements
Statements
in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not
historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking
statements and terms such as “anticipate,” “expect,” “intend,” “may,” “will,” “should”
or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in
the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its
management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements
are based on management’s expectations and assumptions as of the date of this press release and are subject to certain risks and
uncertainties that could cause actual results to differ materially, including, but not limited to the potential approval of OST-HER2
by the U.S. FDA and other risks and uncertainties described in “Risk Factors” in the Company’s most recent Annual Report
on Form 10-K and other subsequent documents the Company files with the Securities and Exchange Commission. Any forward-looking statements
contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies
specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events
or otherwise.
OS
Therapies Contact Information:
Investor Relations
Harrison
Seidner, PhD
WaterSeid
Partners
OSTX@waterseid.com
Public
Relations
Stephanie
Chen
Elev8
New Media
media@ostherapies.com
https://x.com/OSTherapies
https://www.instagram.com/ostherapies/
https://www.facebook.com/OSTherapies/
https://www.linkedin.com/company/os-therapies/
