false
0001795091
0001795091
2026-10-15
2026-10-15
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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):
October 15, 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
October 15, 2026
Item 1.01. Entry into a Material Definitive
Agreement.
Warrant Exercise Inducement and Exchange Offer
On October 11, 2026, OS Therapies
Incorporated (the “Company”) commenced an offer (the “Inducement Offer”) to less than 10 accredited investors
(the “Holders”) that beneficially own certain of the Company’s outstanding warrants (collectively, the “Existing
Warrants”) to exercise, or pre-fund the exercise of, their Existing Warrants for cash at a reduced exercise price of $1.30 per share
(the “Inducement Exercise Price”) pursuant to inducement offer letters (the “Inducement Letters”). The Existing
Warrants consist of (i) warrants to purchase up to an aggregate of 8,038,060 shares of the Company’s common stock, originally issued
in connection with the Company’s warrant exercise inducement and exchange transaction in January 2026, bridge financing in March
2026 and/or registered direct offering in April 2026, having a current exercise price of $1.40 per share, and (ii) warrants to purchase
up to an aggregate of 1,410,000 shares of the Company’s common stock, originally issued in connection with the Company’s secured
convertible promissory note financing in August 2026, having a current exercise price of $2.85 per share.
Pursuant to the Inducement
Letters, each participating Holder will agree to exercise its Existing Warrants for cash at the Inducement Exercise Price. In consideration
for such exercise, the Company will issue to the Holder new common stock purchase warrants (the “New Warrants”) to purchase
a number of shares of the Company’s common stock equal to 100% of the number of shares of the Company’s common stock issued
upon exercise of, or underlying the pre-funded portion of, such Holder’s Existing Warrants (the “New Warrant Shares”).
If all Existing Warrants are exercised or pre-funded, the Company will issue New Warrants to purchase up to an aggregate of 9,448,060
shares of the Company’s common stock. The New Warrants will have an exercise price of $1.40 per share, subject to adjustment as
provided therein, will be immediately exercisable upon issuance and will expire five years from the date of issuance.
In lieu of a cash exercise,
a Holder may elect to pre-fund the exercise of its Existing Warrants by paying the Inducement Exercise Price less $0.001 per share (the
“Pre-Funding Amount”). Upon the Company’s receipt of the Pre-Funding Amount, the exercise price of the applicable Existing
Warrants will automatically be reduced to $0.001 per share (the “Remaining Exercise Price”), and such Existing Warrants will
thereafter be exercisable solely at the Remaining Exercise Price.
The Company has engaged a Securities and Exchange Commission-registered broker-dealer and member firm of the Financial Industry Regulatory Authority,
Inc. (the “Solicitation Agent”) to act as the Company’s exclusive warrant solicitation agent in connection with the
Inducement Offer pursuant to a warrant solicitation agent agreement. The Company has agreed to pay the Solicitation Agent a cash fee equal
to 7.0% of the aggregate gross cash proceeds received by the Company from the exercise and pre-funding of the Existing Warrants, together
with a non-accountable expense allowance of $25,000.
The Inducement Offer commenced
on October 11, 2026 and will expire at 11:59 p.m., Eastern time, on October 30, 2026 (the “Termination Date” and, such period,
the “Inducement Period”). The Inducement Offer may be consummated in one or more closings with respect to exercises or pre-fundings
of the Existing Warrants (each, a “Closing”), at such times and in such amounts as determined at the mutual discretion of
the Company and the Solicitation Agent, which may be held at any time during the Inducement Period or within two business days following
the Termination Date. The Company may, at any time and from time to time, in its discretion and with the consent of the Solicitation Agent,
extend, terminate or suspend the Inducement Period prior to the Termination Date, or extend the time for a Closing, upon written notice
to the Holders without any obligation to extend or reopen the Inducement Period or extend the time for a Closing thereafter.
Each Holder must deliver the
aggregate Inducement Exercise Price or Pre-Funding Amount, as applicable, by wire transfer to a segregated account designated by the Company
no later than two business days after the Holder signs and delivers its Inducement Letter (the “Funding Deadline”), and in
no event later than two business days following the Termination Date (the “Final Funding Date”). If the Company does not receive
the applicable aggregate Inducement Exercise Price or Pre-Funding Amount from a Holder by the Funding Deadline, and in any event by the
Final Funding Date, the Company may, in its sole discretion, cancel such Holder’s warrant exercise or pre-funding, as applicable,
in accordance with the terms of the applicable Inducement Letter.
On October 15, 2026, the Company
completed an initial Closing of the Inducement Offer (the “Initial Closing”), at which seven Holders exercised, or pre-funded
the exercise of, Existing Warrants to purchase an aggregate of 5,517,253 shares of the Company’s common stock and, in exchange,
the Company issued to such Holders New Warrants to purchase up to an aggregate of 5,517,253 shares of the Company’s common stock.
The Company received aggregate gross proceeds of approximately $7.2 million from the Initial Closing and expects to receive aggregate
gross proceeds of approximately $12.3 million if all of the Existing Warrants are exercised or pre-funded pursuant to the Inducement Offer,
in each case before deducting Solicitation Agent fees and other offering expenses payable by the Company. The Company intends to use the
net proceeds to fund clinical development activities, including ongoing and planned clinical trials, regulatory activities and activities
in preparation for commercialization, and for general corporate purposes.
The resale of the shares of
the Company’s common stock underlying the Existing Warrants have been registered pursuant to existing registration statements on
Form S-1 (File No. 333-289216) and Form S-3 (File No. 333-289443), declared effective by the SEC on each of August 12, 2025 and August
25, 2025, respectively.
The Company also agreed to
file a registration statement on Form S-3 (or other appropriate form, including on Form S-1, if the Company is not then eligible to register
securities on Form S-3) (the “Resale Registration Statement”) providing for the resale of the shares of common stock issued
or issuable upon exercise of the New Warrants, on or before November 30, 2026, and to use commercially reasonable efforts to have such
Resale Registration Statement declared effective by the SEC within 30 calendar days (or within 90 calendar days in case of “full
review” of the Resale Registration Statement by the SEC) following the initial filing of such Resale Registration Statement and
to keep the Resale Registration Statement effective at all times until the earlier of (i) the time no Holder owns any New Warrants or
New Warrant Shares and (ii) the Free Trading Date (as defined in the Inducement Letters).
Terms of the New Warrants
The following is a summary of certain terms and provisions of the New Warrants.
Duration and Exercise Price
Each New Warrant has an exercise
price of $1.40 per share. The New Warrants are immediately exercisable from the date of issuance and expire on the date that is five years
from such date. The exercise price and number of New Warrant Shares issuable upon exercise of the New Warrants are subject to appropriate
adjustment in the event of stock dividends, stock splits, reverse stock splits, reclassifications or similar events affecting the Company’s
common stock, and holders are entitled to participate in subsequent rights offerings and pro rata distributions to holders of common stock.
Exercisability
The New Warrants are exercisable,
at the option of each 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). A holder (together with its affiliates) may not exercise any portion of such holder’s New Warrants to the extent
that the holder would own more than 4.99% (or, at the election of the holder, 9.99%) of the outstanding common stock immediately after
exercise, except that upon prior notice from the holder to the Company, the holder may increase or decrease the amount of ownership of
outstanding stock after exercising the holder’s New Warrants up to 9.99% of the number of shares of the Company’s common stock
outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of
the New Warrants, provided that any increase will not be effective until 61 days following notice to the Company.
Forced Exercise
The New Warrants provide that,
at any time following issuance, if the closing price of the Company’s common stock on the applicable trading market equals or exceeds
300% of the exercise price then in effect for any 20 consecutive trading days, the Company may, subject to the satisfaction of certain
equity conditions, require the holder to exercise all or a portion of the New Warrants for cash.
Cashless Exercise
If, at the time a holder exercises
its New Warrants, a registration statement registering the resale of the New Warrant Shares under the Securities Act of 1933, as amended
(the “Securities Act”), is not then effective or the prospectus contained therein is not available, then in lieu of making
the cash payment otherwise contemplated to be made to the Company upon such exercise in payment of the aggregate exercise price, the holder
may elect instead to receive upon such exercise (either in whole or in part), the net number of shares of common stock determined according
to a formula set forth in the New Warrants. On the expiration date, the New Warrants will be automatically exercised via cashless exercise.
Rights as a Stockholder
Except as otherwise provided
in the New Warrants or by virtue of the holder’s ownership of shares of the Company’s common stock, such holder of New Warrants
does not have the rights or privileges of a holder of the Company’s common stock, including any voting rights, until such holder
exercises such holder’s New Warrants. The New Warrants provide that the holders of the New Warrants have the right to participate
in pro rata distributions of assets (including dividends) to holders of the Company’s common stock, subject to the beneficial ownership
limitation.
Fundamental Transactions
If at any time the New Warrants
are outstanding, the Company, either directly or indirectly, in one or more related transactions effects a Fundamental Transaction (as
defined in the New Warrants), a holder of New Warrants will be entitled to receive, upon exercise, the number of shares of common stock
of the successor or acquiring corporation or of the Company, if the Company is the surviving corporation, and any additional consideration
receivable as a result of the Fundamental Transaction by a holder of the number of shares of common stock for which the New Warrants are
exercisable immediately prior to the Fundamental Transaction. As an alternative, in the event of a Fundamental Transaction, at the option
of the holder or the successor entity, exercisable at any time concurrently with, or within 30 days after, the consummation of the Fundamental
Transaction (or, if later, the date of the public announcement of the applicable Fundamental Transaction), the Company or the successor
entity shall purchase the unexercised portion of the New Warrants from the holder by paying an amount of cash equal to the Black Scholes
Value (as defined in the New Warrants) of the remaining unexercised portion of the New Warrants on the date of the consummation of such
Fundamental Transaction. However, if the Fundamental Transaction is not within the Company’s control, including not approved by
the Company’s Board of Directors, the holder will only be entitled to receive the same type or form of consideration (and in the
same proportion), at the Black Scholes Value of the unexercised portion of the New Warrant, that is being offered and paid to the holders
of the Company’s common stock in connection with the Fundamental Transaction.
Waivers and Amendments
The New Warrants may be modified
or amended or the provisions of the New Warrants waived with the Company’s and the holder’s written consent.
The forms of New Warrant and
Inducement Letter are filed as Exhibits 4.1 and 10.1, respectively, to this Current Report on Form 8-K. The descriptions of the terms
of the New Warrants and Inducement Letters are not intended to be complete and are qualified in their entirety by reference to such exhibits.
The Inducement Letters contain customary representations, warranties and covenants by the Company and by the Holders, which were made
only for the purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may
be subject to limitations agreed upon by the contracting parties.
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 New Warrants and New Warrant
Shares are being offered and sold by the Company in reliance upon an exemption from the registration requirements of the Securities Act
afforded by Section 4(a)(2) of the Securities Act and/or Rule 506(b) of Regulation D promulgated thereunder. Neither the New Warrants
nor the New Warrant Shares have been registered under the Securities Act or applicable state securities laws, and such securities may
not be offered or sold in the United States absent registration or an applicable exemption from registration.
This Current Report on Form
8-K does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company.
Item 8.01. Other Events.
On October 19, 2026, the Company issued a press release announcing the Initial Closing, a copy of which is furnished as Exhibit 99.1 to
this Current Report on Form 8-K and incorporated herein by reference.
The information in Item 8.01, including Exhibit 99.1, of this Current Report on Form 8-K shall not be deemed to be “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to
the liabilities under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act, or the Exchange
Act, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number |
|
Description |
| 4.1 |
|
Form of New Warrant. |
| 10.1 |
|
Form of Inducement Offer Letter. |
| 99.1 |
|
Press Release issued by OS Therapies Incorporated on October 19, 2026. |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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: October 19, 2026 |
By: |
/s/ Francis Knuettel II |
| |
|
Name: |
Francis Knuettel II |
| |
|
Title: |
Chief Financial Officer |
Exhibit 99.1
OS Therapies Announces
Initial Closing of Warrant Exercise Inducement and Exchange Offer for Initial Gross Proceeds of Approximately $7.2 Million
| · | Proceeds from the initial closing, together with accrued refundable U.K. R&D tax credits, expected to provide operating runway
through major upcoming milestones |
| · | Company expects to complete early market access regulatory approval submissions for Herlystic™ (“OST-HER2” or
“daznelimgene lisbac”) in the U.S., U.K., Europe and Australia in the fourth quarter of 2026 |
Grasonville, MD - Monday, October 19, 2026
– OS Therapies Inc. (NYSE American: OSTX) (“OS Therapies” or the “Company”), the world leader in gene-edited,
Listeria-based cancer immunotherapies, today announced the initial closing of a warrant exercise inducement and exchange offer that was
made to nine accredited investors (the “Holders”) that beneficially owned common stock purchase warrants (the “Existing
Warrants”) to exercise, or pre-fund the exercise of, their Existing Warrants for cash at a reduced exercise price of $1.30 per share
(or $1.299 per share for a pre-funding). At the initial closing, seven Holders exercised, or pre-funded the exercise of, Existing Warrants
to purchase an aggregate of 5,517,253 shares of common stock, resulting in a total of $7.2 million in gross proceeds to the Company, before
deducting solicitation agent fees and other offering expenses payable by the Company. A significant majority of the Existing Warrants
exercised or pre-funded by the seven Holders had an exercise price of $1.40 per share, reflecting strong support for the Company’s
mission while minimizing dilution to existing stockholders.
In consideration for such exercise or pre-funding,
the Company issued to the participating Holders new common stock purchase warrants to purchase up to an aggregate of 5,517,253 shares
of common stock at an exercise price of $1.40 per share. The offer, which is scheduled to expire at 11:59 p.m., Eastern time, on October
30, 2026, unless extended or earlier terminated, was made only to the Holders and is not available to any other person. A description
of the material terms of the offer is included in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission.
Additionally, the Company has accrued $7 million
in refundable research and development tax credits through its U.K. subsidiary (“R&D Tax Credits”). The tax credit filing
with His Majesty’s Revenue and Customs, the UK’s tax authority, is expected to be submitted during the fourth quarter of 2026,
with receipt of the credit expected in early 2027.
The Company expects to use the net proceeds
to support regulatory filings and commercial preparation activities related for Herlystic™ in the prevention or delay of
recurrence in fully resected, pulmonary metastatic osteosarcoma in the U.S., U.K., European Union (EU) and Australia (the “Human
Metastatic Osteosarcoma Program”), and for general corporate purposes.
“We expect the proceeds from this warrant
inducement transaction to provide the Company with the capital needed to advance our pending Herlystic™ early market access
submissions with regulators in the U.S., U.K., Europe and Australia,” said Chair & CEO Paul Romness. “We remain steadfast
in our mission of improving treatment options for osteosarcoma patients.”
The Company reiterates its intention to submit
a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) under the Accelerated Approval Program (Accelerated
Approval) and Conditional Marketing Authorisation Applications (CMAAs) to the U.K. Medicines and Healthcare products Regulatory Authority
(MHRA), the European Medicines Agency (EMA) and the Australian Therapeutic Goods Administration (TGA) in the fourth quarter of 2026.
Herlystic™ has received Orphan
Drug Designation (ODD), Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) from the FDA, as well as ODD, PRIME
(European FTD equivalent) and ATMP from the EMA. Under the RPDD program, if the Company’s BLA is approved, the Company may become
eligible to receive a Priority Review Voucher (PRV), which it intends to sell. The most recent PRV sale occurred in October 2026 for $203
million. There can be no assurance that the Company will receive a PRV or realize a comparable value, if any, from any future PRV sale.
OS Therapies has completed resubmission of a Regenerative Medicine Advanced Therapy (RMAT) designation request and the Company’s Commissioner’s
National Priority Voucher (CNPV) letter of intent has been accepted by FDA.
No Offer to Sell or Solicit
This press release is for informational purposes
only and does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these
securities in in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or jurisdiction. The new common stock purchase warrants and the shares of common
stock issuable upon exercise thereof were offered and issued in a private placement in reliance on the exemption from registration provided
by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Rule 506(b) of Regulation D promulgated
thereunder, have not been registered under the Securities Act or applicable state securities laws, and may not be offered or sold in the
United States absent registration with the Securities and Exchange Commission or an applicable exemption from such registration requirements.
About OS Therapies
OS Therapies is a clinical stage oncology
company focused on the identification, development, and commercialization of treatments for Osteosarcoma and other solid tumors. The Company
is the world leader in gene-edited, Listeria-based cancer immunotherapies. Herlystic™, 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. Herlystic™
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. Herlystic™
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 Advanced Therapy Medicinal Products (ATMP) from the European Medicines Agency.
The Company reported positive data in its
Phase 2b clinical trial of Herlystic™ in the prevention or delay of recurrence in fully resected, pulmonary 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 intends to submit a Biologics License Application (BLA) request to the U.S. FDA for Herlystic™
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 requesting Conditional Marketing Authorisation Applications from the U.K.’s Medicines and Healthcare products
Regulatory Agency (MHRA) the European Medicines Agency (EMA) and the Australian Therapeutic Goods Administration (TGA) for Herlystic™
in the fourth of 2026. Herlystic™ 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. Herlystic™ was previously 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 silicon 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 regarding
future expectations, plans, prospects or performance, as well as any other statements that are not historical facts, may constitute forward-looking
statements within the meaning of the federal securities laws. Forward-looking statements are generally identified by words such as “anticipate,”
“believe,” “could,” “expect,” “intend,” “may,” “plan,” “potential,”
“should,” “will” and similar expressions, although not all forward-looking statements contain these words. Forward-looking
statements in this press release include, without limitation, statements regarding any subsequent closings of the warrant inducement and
exchange offer, the expected use of net proceeds, the Company’s expected cash runway, the receipt of R&D Tax Credits, the timing
of regulatory submissions and the potential receipt and sale of a PRV. These statements are based on the current expectations and assumptions
of OS Therapies and its management and are subject to risks and uncertainties that could cause actual results to differ materially from
those expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: whether additional
Holders exercise or pre-fund their Existing Warrants; the Company’s ability to obtain additional financing; the timing and receipt
of R&D Tax Credit refunds; the timing and outcome of regulatory submissions and potential approval of Herlystic™ by the
U.S. FDA and applicable foreign regulatory authorities; and other risks and uncertainties described under the heading “Risk Factors”
in the Company’s most recent Annual Report on Form 10-K and in its other filings with the Securities and Exchange Commission. The
forward-looking statements contained in this press release speak only as of the date of this press release, and OS Therapies undertakes
no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise,
except as required by applicable law.
OS Therapies Contact Information:
INVESTOR CONTACT
Harrison Seidner, PhD
WaterSeid Partners
OSTX@waterseid.com
MEDIA CONTACT
Steven Weiss
Executive Vice President
Rubenstein Public Relations
sweiss@rubensteinpr.com
212-805-3062
https://x.com/OSTherapies
https://www.instagram.com/ostherapies/
https://www.facebook.com/OSTherapies/
https://www.linkedin.com/company/os-therapies/
