OS Therapies to Spinoff OS Animal Health into Standalone Public Company
OS Therapies (NYSE American: OSTX) announced plans to spin off its wholly owned subsidiary OS Animal Health (OSAH) as a standalone public company, targeting a U.S. national exchange listing in H1 2026. Shareholders are expected to receive direct equity participation in OSAH if the transaction proceeds. The company cited prior USDA conditional approval of canine OST-HER2, ongoing regulatory engagement including the FDA's Aug 18, 2025 draft guidance, and a forthcoming seminal publication supporting OST-HER2. Management has held preliminary NYSE discussions and engaged investors, KOLs, and potential manufacturers.
OS Therapies estimates a U.S. OST-HER2 addressable opportunity > $150M and references veterinary oncology market growth to $4.77B by 2034.
OS Therapies (NYSE American: OSTX) ha annunciato piani per scorporare la sua controllata interamente di proprietà OS Animal Health (OSAH) come società pubblica indipendente, con l'obiettivo di una quotazione su una borsa nazionale statunitense nell'H1 2026. Si prevede che gli azionisti ricevano una partecipazione azionaria diretta in OSAH se l'operazione dovesse procedere. L'azienda ha citato l'approvazione condizionata USDA per il cane OST-HER2, il continuo coinvolgimento regolatorio incluso il draft guidance della FDA del 18 ago 2025, e una futura pubblicazione seminale a supporto di OST-HER2. Il management ha condotto consultazioni preliminari con NYSE e ha coinvolto investitori, KOLs e potenziali produttori.
OS Therapies stima che l'opportunità addressable negli Stati Uniti per OST-HER2 sia > $150M e fa riferimento alla crescita del mercato di oncologia veterinaria fino a $4.77B entro il 2034.
OS Therapies (NYSE American: OSTX) anunció planes para escindir su subsidiaria 100% propiedad OS Animal Health (OSAH) como una empresa pública independiente, con miras a cotizar en una bolsa nacional de EE. UU. en H1 2026. Se espera que los accionistas reciban participación accionaria directa en OSAH si la operación prospera. La compañía citó la previa aprobación condicionada de USDA para el canino OST-HER2, la interacción regulatoria en curso, incluido el borrador de directrices de la FDA del 18 de agosto de 2025, y una próxima publicación seminal que respalde OST-HER2. La dirección ha mantenido conversaciones preliminares con NYSE y ha involucrado a inversionistas, KOLs y posibles fabricantes.
OS Therapies estima una oportunidad direccionable en EE. UU. para OST-HER2 de > $150M y se refiere al crecimiento del mercado de oncología veterinaria hasta $4.77B para 2034.
OS Therapies (NYSE American: OSTX)은 자회사 OS Animal Health (OSAH)를 완전 소유 독립 공기업으로 분리하여 H1 2026에 미국의 국내거래소 상장을 목표로 한다고 발표했다. 거래가 진행될 경우 주주들은 OSAH에 직접적인 지분 참여를 받게 될 것으로 예상된다. 회사는 이전의 USDA 조건부 승인의 개에 대한 OST-HER2, 2025년 8월 18일 FDA의 초안 지침 및 OST-HER2를 뒷받침하는 곧 발표될 결정적 연구를 인용했다. 경영진은 NYSE와의 예비 논의와 투자자, KOL, 잠재 제조업체를 포함한 이해관계자와의 참여를 진행했다.
OS Therapies는 미국 내 OST-HER2의 주소 지정 가능한 기회가 > $150M이며, 수의학 종양학 시장이 2034년까지 $4.77B에 이를 것으로 예상된다.
OS Therapies (NYSE American: OSTX) a annoncé des plans pour séparer sa filiale entièrement détenue OS Animal Health (OSAH) en une société publique indépendante, en visant une cotation sur une bourse nationale américaine au 1er semestre 2026. Les actionnaires devraient recevoir une participation directe au capital d'OSAH si l'opération se déroule. La société a cité l'ancienne approbation conditionnelle de l'USDA pour le OST-HER2 canin, un engagement réglementaire en cours incluant le projet de ligne directrice de la FDA daté du 18 août 2025, et une prochaine publication clé soutenant OST-HER2. La direction a mené des discussions préliminaires avec le NYSE et a engagé des investisseurs, des KOL et des fabricants potentiels.
OS Therapies estime une opportunité adressable américaine pour OST-HER2 supérieure à $150M et se réfère à la croissance du marché d’oncologie vétérinaire jusqu’à $4.77B d’ici 2034.
OS Therapies (NYSE American: OSTX) hat Pläne angekündigt, seine vollständig im Eigentum befindliche Tochter OS Animal Health (OSAH) abzutrennen und als eigenständiges börsennotiertes Unternehmen zu führen, mit dem Ziel einer Notierung an einer US-Nationalbörse im 1. Halbjahr 2026. Aktionäre sollen eine direkte Eigenkapitalbeteiligung an OSAH erhalten, falls die Transaktion zustande kommt. Das Unternehmen verwies auf die frühere USDA-konditionale Zulassung von canine OST-HER2, laufende regulatorische Kontakte einschließlich der FDA-Draft-Richtlinien vom 18. August 2025 und eine bevorstehende wegweisende Veröffentlichung, die OST-HER2 unterstützt. Das Management hat Preliminary NYSE-Gespräche geführt und Investoren, KOLs und potenzielle Hersteller eingebunden.
OS Therapies schätzt eine adressierbare US-Möglichkeit für OST-HER2 > $150M und verweist auf das Wachstum des Marktes für Veterinär-Onkologie bis $4.77B bis 2034.
OS Therapies (NYSE American: OSTX) أعلنت عن خطط لفصل شركتها الفرعية المملوكة بالكامل OS Animal Health (OSAH) كشركة عامة مستقلة، مع استهداف إدراج في بورصة وطنية أمريكية في النصف الأول من 2026. من المتوقع أن يحصل المساهمون على مشاركة رأس مال مباشرة في OSAH إذا سارت الصفقة قدماً. أشارت الشركة إلى الموافقة المشروطة لوزارة الزراعة الأمريكية على OST-HER2 الخاص بالكلاب، والتفاعل التنظيمي الجاري بما في ذلك مشروع إرشادات FDA بتاريخ 18 أغسطس 2025، وورقة علمية رائدة ستدعم OST-HER2. قامت الإدارة بإجراء مناقشات أولية مع NYSE وشركاء المستثمرين وKOLs والمصنعين المحتملين.
تقدر OS Therapies الفرصة القابلة للوصول في الولايات المتحدة لـ OST-HER2 بأكثر من $150M وتشير إلى نمو سوق الأورام البيطرية حتى $4.77B بحلول 2034.
- Targeted standalone listing in H1 2026
- Shareholder direct equity participation in OSAH
- Prior USDA conditional approval for canine OST-HER2
- Estimated U.S. OST-HER2 addressable opportunity > $150M
- No assurance an IPO, direct listing, or spinoff will occur on planned timeline
- Possible market uncertainty if USDA reauthorization is delayed or denied
- Transaction may dilute parent value or fail to deliver anticipated benefits
Insights
OS Therapies plans a 1H 2026 spinoff of OS Animal Health to create a separately financed public company focused on OST-HER2.
OS Therapies intends to list OS Animal Health (OSAH) on a U.S. national exchange in
Key dependencies and risks include completing a public listing, securing USDA reauthorization for market relaunch, and finalizing management and manufacturing partnerships. The company cites veterinary oncology market estimates of
Watch for three concrete milestones in the near term: confirmation of a listing structure and timeline in
- Successful preliminary discussion with NYSE representatives and potential investors
- OS Therapies shareholders to receive direct equity participation in new listing
- 'Shelter Me: Cancer Pioneers' film featuring canine and human patients treated with OST-HER2 receives Anthem Award in the 'Documentary or Film under Awareness Categories, Health' category
- Company congratulates Disney (NYSE: DIS) for winning the 2025 Daytime Emmy 'Outstanding Daytime Special' category and Netflix (NYSE: NFLX) for winning 'Outstanding Writing Team for a Daytime Non-Fiction Program' category
- Veterinary oncology market is expected to grow from
$1.58 billion in 2024 to$4.77 billion in 2034 according to Towards Health
New York, New York--(Newsfile Corp. - November 20, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced its intent to spin off OS Animal Health, Inc. (OSAH) into a standalone public company listed on a national stock exchange. OSAH is the Company's wholly owned subsidiary developing OST-HER2 for canine osteosarcoma. The Company expects OSAH to become a standalone public company on a U.S. national stock exchange in the first half of 2026.
"Having been a part of the effort to improve the standard of care for dogs with osteosarcoma for over a decade, I'm pleased that OS Therapies has made the decision to have the animal health program be housed in a standalone, separately financed venture so that it can receive the attention it deserves," said Edward Robb, DVM, Animal Health Strategic Advisor for OS Therapies. "I will be taking on a key senior management position with OS Animal Health and will be working to help recruit the best leadership in the veterinary space to support a successful commercial launch once the product receives the necessary regulatory authorizations to relaunch in the United States. The veterinary oncology market is expected to grow from
OST-HER2 was featured in the critically acclaimed film "Shelter Me: Cancer Pioneers" that recently won an Anthem Award in the for 'Documentary or Film under Awareness Categories, Health' category and was nominated for 2025 Emmy Daytime Awards in the 'Outstanding Daytime Special' category, won by Disney's (NYSE: DIS) 'Disney Parks Magical Christmas Day Parade' and in the 'Outstanding Writing Team for a Daytime Non-Fiction Program' category won by Netflix's 'Black Barbie'.
"We have spent the last several months engaging with key opinion leaders, regulatory experts, management candidates, potential investors and potential USDA-registered commercial manufacturers, who together would create the critical mass needed to make this standalone animal health venture a success," said Paul Romness, MPH, Chairman & CEO of OS Therapies. "With a path forward for OST-HER2 in human osteosarcoma based upon the FDA's August 18, 2025 Draft Regulatory Guidance that outlines the importance of increasing Overall Survival as the overarching efficacy endpoint in oncology clinical trials, we believe it is now prudent to have a separately financed entity bringing the canine version of this product forward."
Mr. Romness continued, "Given that canine OST-HER2 has previously been conditionally approved by the U.S. Department of Agriculture (USDA) for canine osteosarcoma, and that a seminal publication related to its additional uses in preventing metastatic disease progression and controlling primary disease is forthcoming in the near future, we have a high degree of confidence that USDA will allow OST-HER2 back on the market. We believe it is important for OS Therapies shareholders to end up with direct equity participation in OSAH once it becomes a public company."
According to Grandview Research, the veterinary oncology market is valued at
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 early 2026 and, if approved, would become eligible to receive a Priority Review Voucher that it intends to 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/275301
FAQ
What is OS Therapies' timeline to spin off OS Animal Health (OSTX)?
Will OSTX shareholders receive shares of OS Animal Health after the spinoff?
What regulatory status does canine OST-HER2 have ahead of the spinoff?
How large is the market opportunity OS Therapies cites for OST-HER2 in U.S. dogs?
How does the FDA Draft Guidance dated Aug 18, 2025 affect the human OST-HER2 program?
Is the spinoff of OSAH guaranteed to happen as announced by OSTX?
