OS Therapies Enters into Warrant Inducement Agreements

Rhea-AI Summary

OS Therapies (NYSE: OSTX) announced a warrant exercise inducement and exchange with nine accredited investors that generated $7.53 million in gross proceeds. The company said all nine holders agreed to exercise or prefund their existing warrants, providing runway into 2027. Net proceeds are planned to support regulatory filings and commercial preparation for OST-HER2 in prevention or delay of recurrent pulmonary metastatic osteosarcoma in the U.S., U.K., and EU, and to fund preparations for a proposed spinoff of its wholly owned subsidiary OS Animal Health. The company reiterated intent to file a BLA by end of January 2026 and to submit a MAA to MHRA by end-February 2026 and to EMA by March 2026, with target approval windows across 2026. OST-HER2 holds FDA Orphan Disease, FDA/EMA Fast Track, and FDA Rare Pediatric Disease designations; a Priority Review Voucher may be available if Accelerated Approval is received before September 30, 2026.

Positive

• Raised $7.53M gross proceeds from existing warrant holders
• Provides company runway into 2027
• Proceeds designated to support OST-HER2 regulatory filings and commercial preparation
• Planned BLA submission by end of January 2026 and MAA submissions by Feb–Mar 2026

Negative

• No assurance any spinoff of OS Animal Health will occur or meet contemplated timelines
• Regulatory approval timelines are targets, not guarantees
• Potential increase in outstanding shares from warrant exercises may affect shareholders

News Market Reaction

-7.10% 1.9x vol

18 alerts

-7.10% News Effect

-13.4% Trough in 7 hr 6 min

-$4M Valuation Impact

$57M Market Cap

1.9x Rel. Volume

On the day this news was published, OSTX declined 7.10%, reflecting a notable negative market reaction. Argus tracked a trough of -13.4% from its starting point during tracking. Our momentum scanner triggered 18 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $4M from the company's valuation, bringing the market cap to $57M at that time. Trading volume was above average at 1.9x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Warrant proceeds: $7.53M gross Participating investors: 9 investors Regulatory runway: Into 2027 +5 more

8 metrics

Warrant proceeds $7.53M gross Raised from nine existing investors via warrant inducement

Participating investors 9 investors All nine offered holders agreed to participate

Regulatory runway Into 2027 Company states proceeds provide capital runway into 2027

BLA timing Jan 2026 Planned BLA filing with FDA by end of January 2026

MAA timing Feb–Mar 2026 UK MAA by end Feb 2026; EU MAA by March 2026

Recent PRV sale $160M Most recent public Priority Review Voucher sale in June 2025

RPDD deadline Sep 30, 2026 Must receive Accelerated Approval by this date to be PRV-eligible

Shelf capacity $100,000,000 Maximum aggregate amount under S-3 shelf filed August 2025

Market Reality Check

Price: $1.46 Vol: Volume 854,629 is 1.65x t...

high vol

$1.46 Last Close

Volume Volume 854,629 is 1.65x the 20-day average of 517,412 shares. high

Technical Shares at $1.55, trading below 200-day MA of $1.81 and 77.86% under 52-week high.

Peers on Argus

OSTX was up 0.65% with elevated volume, while close biotech peers showed mixed m...

OSTX was up 0.65% with elevated volume, while close biotech peers showed mixed moves: ANL up 5.26%, ATHE up 3.53%, and BYSI, IMMX, ACET down between 0.62% and 3.94%, pointing to stock-specific factors.

Historical Context

5 past events · Latest: Jan 05 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 05	Corporate outlook	Positive	+7.5%	Outlined H1 2026 plan for OST-HER2 filings and key data readouts.
Dec 15	Regulatory meeting	Positive	-7.7%	Successful FDA Type C meeting confirming path to BLA via Accelerated Approval.
Dec 09	Regulatory meeting	Positive	+0.0%	Successful UK MHRA pre-MAA meeting and agreement on confirmatory study design.
Dec 05	Regulatory update	Positive	+5.5%	FDA BLA fee waiver and EMA Union Marketing Authorisation eligibility for OST-HER2.
Nov 25	Naming milestone	Positive	+4.7%	WHO granted the INN 'daznelimgene lisbac' for OST-HER2, supporting global filings.

Pattern Detected

Recent OSTX headlines around OST-HER2 and regulatory progress have mostly seen positive or flat reactions, with one notable divergence where favorable FDA feedback coincided with a share decline.

Recent Company History

Over the last few months, OS Therapies has focused on advancing OST‑HER2 toward Accelerated Approval and conditional approvals in the U.S., U.K., and EU. News on WHO naming, EMA Union Marketing Authorisation eligibility, and positive U.S./UK regulatory interactions often coincided with gains of 4–7% or flat trading. A December FDA Type C update saw a -7.73% move despite constructive feedback. Today’s financing and runway extension fit into this push toward planned 2026 filings and potential approvals.

Regulatory & Risk Context

Active S-3 Shelf · $100,000,000

Shelf Active

Active S-3 Shelf Registration 2025-08-08

$100,000,000 registered capacity

An effective S-3 shelf filed on 2025-08-08 allows OS Therapies to offer up to $100,000,000 of securities, plus an at-the-market component of $18,000,000. This provides flexibility to raise additional capital beyond the current $7.53M warrant inducement, which can be supportive for funding development and commercialization but also represents ongoing potential equity issuance.

Market Pulse Summary

The stock moved -7.1% in the session following this news. A negative reaction despite added capital ...

Analysis

The stock moved -7.1% in the session following this news. A negative reaction despite added capital could fit prior instances where constructive regulatory updates were met with weakness, as seen after the December FDA Type C meeting. The $7.53M warrant inducement extends runway into 2027 but may raise dilution concerns, especially alongside an existing $100,000,000 shelf and $18,000,000 ATM capacity. Past news around OST‑HER2 has more often aligned positively with price, so a sharp decline would represent a notable divergence from most recent patterns.

Key Terms

warrant exercise inducement, accredited investors, biologics licensing application (bla), accelerated approval, +4 more

8 terms

warrant exercise inducement financial

"announced that it launched a warrant exercise inducement and exchange offer"

A warrant exercise inducement is an extra benefit offered to holders of warrants to persuade them to convert those warrants into shares sooner or at all. Think of it like a limited-time bonus or coupon that makes using the warrant more attractive; it matters to investors because it can increase the number of shares outstanding, dilute existing ownership, change control stakes, and alter a company’s cash or equity position.

accredited investors financial

"exchange offer to nine accredited investors (the "Holders") that hold"

Accredited investors are individuals or entities considered to have enough financial knowledge and resources to understand and handle more complex and risky investments. They are often allowed to participate in private investment opportunities that are not available to the general public, similar to how experienced players might access exclusive clubs or events. This status helps ensure that investors can manage potential risks and rewards appropriately.

biologics licensing application (bla) regulatory

"intention to file a Biologics Licensing Application (BLA) with the U.S. FDA"

A biologics licensing application (BLA) is a formal regulatory request submitted to health authorities asking for permission to sell a biological medicine, such as vaccines, therapeutic proteins, or cell therapies. Investors care because approval is the gateway to commercial sales and revenue, while rejection or delays signal development, safety or manufacturing issues; think of it like applying for a driver’s license for a complex product—approval lets it legally hit the market, while problems keep it grounded.

accelerated approval regulatory

"with the U.S. FDA under the Accelerated Approval Program (Accelerated Approval)"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

marketing authorisation application (maa) regulatory

"intends to complete Marketing Authorisation Application (MAA) submissions"

An marketing authorisation application is a formal request submitted to a health regulator asking for permission to sell a new medicine or medical product in a given market. For investors it matters because approval is the regulatory ‘green light’ that allows commercial sales and revenue, while delays, additional requirements, or rejection create uncertainty about timing, costs and a product’s market potential.

orphan disease designation (odd) regulatory

"OST-HER2 has received FDA Orphan Disease Designation (ODD) and Fast Track"

A regulatory label granted to a drug or therapy aimed at treating a very small patient population; it gives the developer special incentives such as longer exclusive sales rights, financial benefits, and regulatory support to help bring the product to market. Think of it as a government ‘helping hand’ that can shrink development costs and speed approval, which matters to investors because it can raise a treatment’s commercial value and reduce the financial risk of development.

rare pediatric disease designation (rpdd) regulatory

"has received Rare Pediatric Disease Designation (RPDD) from FDA."

A rare pediatric disease designation (RPDD) is an official label given by regulators to a drug or therapy aimed at treating a serious, uncommon disease that primarily affects children. It signals that the treatment addresses a small, high-need patient group and can bring regulatory benefits—think of it as a “fast-pass” and financial boost that can shorten development steps, reduce certain costs, and sometimes produce transferable vouchers or other marketable perks, all of which can increase a program’s commercial value for investors.

priority review voucher (prv) regulatory

"it will become eligible to receive a Priority Review Voucher (PRV)"

A priority review voucher (PRV) is a transferable regulatory 'fast pass' that speeds up a government agency’s review of a drug or medical product, shortening the time it takes to get approval. For investors, a PRV is a valuable asset because it can both accelerate a product’s path to market—potentially bringing revenue sooner—and be sold to other companies, creating a direct one-time or strategic financial benefit.

AI-generated analysis. Not financial advice.

• $7.53M gross proceeds raised from pre-existing investors, providing capital runway into 2027
• All nine investors that were offered agreed to participate
• Net proceeds to fund OST-HER2 regulatory approval submissions, commercial preparation activities and preparations for OS Animal Health proposed spinoff transaction

New York, New York--(Newsfile Corp. - January 12, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in listeria-based cancer immunotherapies, today announced that it launched a warrant exercise inducement and exchange offer to nine accredited investors (the "Holders") that hold common stock purchase warrants issued in connection with the Company's previous third quarter 2025 warrant exercise inducement and exchange offers (the "Existing Warrants"). All nine Holders offered have entered into inducement offer letter agreements with the Company to exercise or pre-fund for cash all of their Existing Warrants, providing a total of $7.53 million in gross proceeds to the Company. A description of the material terms of the transaction is included in the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission.

Ceros Capital Markets, a division of Ceros Financial Services, Inc., acted as the exclusive warrant solicitation agent for the transaction.

The gross proceeds raised provide the Company runway into 2027, and the Company expects to use the net proceeds to support regulatory filings and commercial preparation activities related for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma in the U.S., UK and European Union (the "Human Metastatic Osteosarcoma Program"), to provide funding for the Company's wholly owned subsidiary OS Animal Health's proposed spinoff transaction preparations, and general corporate purposes.

"We greatly appreciate the support of our long-term shareholders who have been funding the Company since it was private," said Chairman & CEO Paul Romness. "Now that we have addressed market concerns related to our cash position, we are poised to announce the biomarker data from the Phase 2b trial from our Human Metastatic Osteosarcoma Program and file for regulatory approval in the U.S. UK and EU. Additionally, we are excited about the spinoff of our wholly owned subsidiary OS Animal Health ("OSAH") that is expected to result in OS Therapies shareholders becoming shareholders of OSAH."

The Company reiterates its intention to file a Biologics Licensing Application (BLA) with the U.S. FDA under the Accelerated Approval Program (Accelerated Approval) by the end of January 2026. The Company intends to complete Marketing Authorisation Application (MAA) submissions to gain conditional marketing authorization with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and Europe's European Medicines Agency (EMA) by end of February 2026 and March 2026, respectively. The Company is hopeful to gain regulatory approval for OST-HER2 in the UK in the second quarter of 2026, in the United States in the third quarter or 2026 and in Europe by the end of the fourth quarter of 2026.

OST-HER2 has received FDA Orphan Disease Designation (ODD) and Fast Track Designation from FDA & EMA and has received Rare Pediatric Disease Designation (RPDD) from FDA. Under the RPDD program, if the Company receives Accelerated Approval prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to monetize, subject to market conditions. The most recent publicly disclosed PRV sale, valued at $160 million, occurred in June 2025; however, there can be no assurance that the Company would realize a comparable value, if any, in connection with any future PRV sale.

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 securities in connection with the proposed spinoff or otherwise unless made in compliance with applicable securities laws. Any distribution of shares or other issuance of securities in connection with the proposed spinoff or otherwise will be made only pursuant to an effective registration statement or an applicable exemption from registration.

No assurance can be given that any initial public offering, direct listing, or spinoff of OSAH will occur, or that any such transaction, if undertaken, will be completed on the terms or within the timeline currently contemplated. Even if any such transaction is completed, no assurance can be given that the newly independent company will operate as expected, that anticipated benefits of such transaction will be realized or that the trading value of the parent company and the separated company, individually or in the aggregate, will equal or exceed the Company's current value.

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 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 has received Rare Pediatric Disease Designation (RPDD) from the U.S. Food & Drug Administration and Fast-Track and Orphan Drug designations from the U.S. FDA and 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 statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a Biologics Licensing Application (BLA) to 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. 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.

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 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, most recent Quarterly Report on Form 10-Q 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/

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/280045

FAQ

How much did OS Therapies (OSTX) raise from the warrant inducement on January 12, 2026?

$7.53 million in gross proceeds from nine existing warrant holders.

What will OSTX use the warrant proceeds for and how long is the runway?

Net proceeds are earmarked for OST-HER2 regulatory and commercial preparation, OS Animal Health spinoff preparations, and general corporate purposes, providing runway into 2027.

When does OS Therapies intend to file the BLA and MAAs for OST-HER2 (OSTX)?

The company intends to file a BLA by end of January 2026, an MHRA MAA by end of February 2026, and an EMA MAA by March 2026.

Is OST-HER2 eligible for a Priority Review Voucher (PRV) for OSTX?

OST-HER2 has Rare Pediatric Disease designation; if Accelerated Approval is received before Sept 30, 2026, the company would be eligible to seek a PRV.

Will OS Therapies definitely spin off OS Animal Health (OSTX)?

No assurance is given that any spinoff, initial public offering, or direct listing of OS Animal Health will occur or be completed on the currently contemplated terms or timeline.