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OS Therapies (NYSE American: OSTX) reported Q1 2026 results and a business update focused on lead candidate OST‑HER2 in metastatic osteosarcoma. The company raised $11.2 million in Q1 and early Q2 2026 and expects cash runway into 2027.
OS Therapies reported a Q1 2026 net operating loss of $10.396 million, or $0.27 per share. The company advanced regulatory filings, including EMA rolling review of a conditional MAA for OST‑HER2, and progressed an S‑1 for the proposed go‑public transaction of subsidiary OS Animal Health.
AI-generated analysis. Not financial advice.
Following this news, OSTX has declined 8.24%, reflecting a notable negative market reaction. Argus tracked a trough of -10.0% from its starting point during tracking. Our momentum scanner has triggered 32 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $1.73. This price movement has removed approximately $7M from the company’s valuation. Trading volume is above average at 1.8x the average, suggesting increased trading activity.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.
Argus momentum scanner shows 6 biotech peers (e.g., ACET, ATHE, ANL) moving up with median gains around 6.9%, indicating OSTX traded within a broader positive biotech tape rather than in isolation.
Earnings releases for OSTX have historically been followed by modest negative average moves (-4.24%), despite generally positive clinical and regulatory updates.
Across the last five earnings or results updates from Nov 2024 through Nov 2025, OS Therapies consistently reported widening net operating losses alongside advancing OST-HER2 toward BLA and MAA filings. Capital raises such as a $7.8M warrant exercise and a $4.2M financing extended runway, while Phase 2b data showed statistically significant survival benefits. Market reactions skewed slightly negative after these earnings-type updates, even when clinical news was positive.
Over the past five earnings-related releases, OSTX moved an average of -4.24%, showing that financial updates with clinical progress have often been met with mild selling.
Earnings updates show progression from Phase 2b data readouts and IPO funding through BLA and MAA planning, with recurring net operating losses offset by financings that extended cash runway into subsequent years.
An effective Form S-3 shelf dated Aug 8, 2025 allows OS Therapies to issue up to $100,000,000 in securities, including an at-the-market component of up to $18,000,000. Recent prospectus supplements (e.g., 424B5, 424B7) indicate active usage for equity-linked financings, which can increase dilution if further capacity is tapped.
This announcement combines a larger Q1 2026 net operating loss of $10.396 million with improved liquidity from a $5.5 million offering and roughly $4.5 million in UK VAT and R&D refunds. It outlines alignment with EMA, MHRA, TGA and FDA around 3‑year overall survival endpoints and conditional or accelerated pathways for OST‑HER2. Investors may watch upcoming survival data at ASCO 2026, regulatory meetings, completion of BLA and MAA filings, and execution on the OS Animal Health go‑public strategy.
AI-generated analysis. Not financial advice.
New York, New York and Rockville, Maryland–(Newsfile Corp. – May 18, 2026) – OS Therapies, Inc. (NYSE American: OSTX) (“OS Therapies” or “the Company”), the world leader in gene-edited, listeria-based cancer immunotherapies, reported first quarter 2026 financial results and provided a business update centered on the Company’s lead program for OST-HER2 in the prevention or delay of recurrence in fully-resected, pulmonary metastatic osteosarcoma (“Metastatic Osteosarcoma”).
“In the first quarter of 2026 we successfully implemented our international research & development approach, aligning regulatory and tax strategies via our wholly-owned U.K.-based subsidiary OS Therapies UK Ltd. We made significant investments in order to be able to benefit from return of cash via value-added tax (VAT) reimbursements and refundable research & development tax credits (“R&D Tax Credits”),” said Chris Acevedo, CPA, Chief Financial Officer of OS Therapies. “With approximately
Mr. Acevedo continued, “As we continue with our tax strategy in the U.K. – a jurisdiction that provides attractive incentives for developers of treatments for orphan diseases – we have accrued an additional
First Quarter 2026 Corporate Highlights
“The first quarter was a period of intense biomarker, clinical and regulatory execution for the Company as we initiated filing of our BLA for OST-HER2, completed biomarker analyses from the OST-HER Metastatic Osteosarcoma Phase 2b trial showing strong correlation between seroconversion and survival,” said Paul Romness, MPH, Chair & CEO of OS Therapies. “We also received ATMP status in Europe, raised the capital needed into 2027 and formally began preparations for the Go-Public transaction of OS Animal Health that has now been pushed into the second half of 2026 in order to allow for a planned regulatory meeting with the U.S. Department of Agriculture (USDA) to define the regulatory path forward for OST-HER2 in canine osteosarcoma, including the potential expansion of therapeutic uses into frontline treatment, that we believe is important before setting a valuation for the transaction. We expect clinical data on OST-HER2’s potential in frontline canine osteosarcoma, initially reported in April 2025, to be published in the near future in a peer-reviewed journal that will further underscore the tremendous potential for OST-HER2 to change the standard of care for canine patients.”
Mr. Romness continued, “We are actively preparing for upcoming meetings with FDA and U.K. Medicines and Healthcare products Regulatory Agency (MHRA) following successful meetings with the European Medicines Agency (EMA) and Australia’s Therapeutic Goods Administration (ATGA). There we gained alignment on the clinical efficacy and surrogate clinical efficacy endpoints required to support early market access for of OST-HER2 under upcoming conditional MAA requests, as well as alignment on the provisional design of our confirmatory Phase 3 OST-HER2 Metastatic Osteosarcoma trial. EMA has now initiated rolling review of our conditional MAA, which is also a major regulatory milestone.”
Second Quarter 2026 Highlights to Date and Upcoming Milestones
Highlights to date
Upcoming milestones
Key Second Half of 2026 Milestones
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 most recent PRV sale occurred in April 2026 for
Loss from Operations:
The Company recorded a net operating loss of
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities.
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 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 anticipates receiving 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 Authorisations 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 also anticipates reading out data from a Phase 1b study of OST-504 in castration resistant prostate cancer in the first half of 2026.
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 our cash runway expectations, our expected cash returns through VAT reimbursement and R&D Credits, the potential approval of OST-HER2 by the U.S. FDA and foreign regulatory agencies, 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
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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/297769
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