OS Therapies Reports Second Quarter 2026 Financials and Provides Business and Regulatory Updates
Rhea-AI Summary
OS Therapies (NYSE American: OSTX) reported second quarter 2026 results and regulatory progress for lead immunotherapy OST-HER2 in metastatic osteosarcoma. The company arranged up to $10 million in debt financing backed by U.K. VAT refunds and reimbursable R&D tax credits, with $5 million funded at the August 10, 2026 first closing.
According to OS Therapies, OST U.K. had over $3 million VAT refunds receivable at June 30, 2026 and expects about $1 million additional VAT refunds plus at least $4.2 million refundable R&D tax credits by Q3-end, supporting a projected financial runway into 2027.
Clinically, 2.5‑year overall survival in the Metastatic Osteosarcoma Program was 75% vs. 47% (p = 0.003), with no new deaths between 2‑year and 2.5‑year timepoints in the OST‑HER2 group. Regulators including FDA, EMA, MHRA and TGA have aligned on 3‑year overall survival and biomarker endpoints and Phase 3 design. Q2 2026 net operating loss was $8.576 million versus $4.839 million a year earlier; net loss per share was $0.20 on 43.904 million weighted average shares.
Positive
- Up to $10 million debt facility with $5 million funded August 10, 2026
- Over $3 million VAT refunds receivable plus at least $4.2 million R&D credits expected
- OST-HER2 2.5-year overall survival 75% vs. 47% (p = 0.003)
- Regulatory alignment on Phase 3 design among FDA, EMA, MHRA, TGA
- Advanced Therapy Medicinal Product designation by EMA enabling Rolling Review
- Multiple FDA/MHRA statistical and biomarker meetings scheduled for Q3 2026
Negative
- Q2 2026 net operating loss increased to $8.576 million from $4.839 million
- Net loss per share $0.20 vs. $0.19 with higher 43.904 million shares outstanding
- Higher expenses from biomarker R&D, regulatory activities and general and administrative costs
News Explained
June 30 cash was $205,035, equal to 3.3 days of Q2 cash use, alongside a $5 million first debt closing within a $10 million maximum.
At
Using the quarter's
The release describes the regulatory program as advancing toward, rather than having completed, its next submissions: FDA and MHRA statistical-method meetings are scheduled for September, while BLA and CMAA submissions and confirmatory Phase 3 initiation are listed as expected second-half milestones.
The next named checkpoints are interim 3-year overall-survival data expected in early September and the mid-September FDA Type C meeting.
Sources and calculations
- OS Therapies Q2 2026 financials and business updates (2026-08-17)
- OS Therapies Q2 2026 fundamentals (2026Q2)
- Cash and equivalents vs quarterly operating cash outflow, in days of cash use $205,035 / ($5,532,872 / 90) = [object Object]
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 18 | Q1 earnings | Negative | -8.0% | Reported operating loss and financing activity alongside regulatory filing progress. |
| Nov 17 | Q3 earnings | Positive | -5.0% | Reported statistically significant survival data and planned regulatory meetings. |
| Aug 19 | Q2 earnings | Positive | -1.4% | Reported significant trial results, financing, and regulatory progress. |
| May 16 | Q1 earnings | Positive | -1.2% | Reported positive Phase 2b data and anticipated FDA regulatory feedback. |
| Mar 31 | FY 2024 earnings | Negative | -13.6% | Reported increased annual operating loss and continued regulatory filing plans. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
All five tag-matched earnings events had negative 24-hour reactions, averaging -5.84%, despite several positive clinical or regulatory updates.
Key Terms
Biologics License Application (BLA) regulatory
Conditional Marketing Accelerated Authorisations (CMAAs) regulatory
Advanced Therapy Medicinal Product (ATMP) regulatory
Pediatric Investigation Plans (PIPs) regulatory
pharmacodynamic response biomarker medical
overall survival medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Up to
$10 million debt financing supported by U.K. subsidiary VAT refunds and reimbursable R&D tax credits, including$5 million funded at the August 10, 2026 first closing - FDA Type C Statistical Methods Meeting mid-September 2026 meeting to review 2.5-year Overall Survival data and confirmatory Phase 3 trial design to gain alignment on statistical analysis plan for BLA submission under the Accelerated Approval Program
- Interim 3-year Overall Survival data expected in early September 2026 ahead of MHRA Statistical Methods Scientific Advice Meeting for Conditional MAA submission acceptance criteria
- Final 3-year Overall Survival data to be included in FDA BLA Accelerated Approval Program submission ahead of Type B Pre-BLA Meeting previously granted in Q2/26
- U.K. waives Pediatric Investigation Plan (PIP) requirement
New York and Rockville, Maryland--(Newsfile Corp. - August 17, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today reported financial results for the second fiscal quarter ended June 30, 2026, and provided business and regulatory updates. The Company is seeking to obtain a Biologics License Application (BLA) under the Accelerated Approval Program of the U.S. Food & Drug Administration (FDA), and equivalent Conditional Marketing Accelerated Authorisations (CMAAs) from the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA), for OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program").
"In the second quarter of 2026, we navigated the administrative processes associated with becoming approved to receive Value Added Tax (VAT) refunds and completing submissions for the reimbursable Research and Development (R&D) Credit Program for which our U.K. subsidiary (OST U.K.) was eligible," said Paul Romness. "With over
"We are now preparing for our mid-September Type C Statistical Method Meeting with FDA that will review our previously disclosed 2.5-year overall survival data to align upon the statistical analysis plan, and also review the design of our confirmatory Phase 3 study expected to be launched in the exclusively in the U.K. to satisfy BLA and CMAA pre-conditions, as well as our Statistical Methods Scientific Advice Meeting (SAM) with MHRA," said Dr. Craig Eagle, Chief Medical Advisor and Director of OS Therapies. "We have also been making significant progress on the Pediatric Investigation Plans (PIPs), or equivalents, required to be included as part of the Accelerated Approval Program BLA and EMA CMAA submission packages. We were pleased to receive a waiver of the PIP requirement in the U.K. by MHRA that obviates that need for our pending MHRA CMAA request. We are hopeful to achieve regulatory alignment that will provide a clear pathway for regulatory our upcoming submissions for early market access in the U.S. and U.K., having already achieved EMA alignment in the second quarter of 2026."
Second Quarter 2026 Corporate Highlights
- Achieved statistically significant 2.5-year Overall Survival data (
75% vs.47% , p = 0.003) with no new deaths between 2-year and 2.5-year timepoints in OST-HER2-treated group - Alignment achieved with EMA and Australian Therapeutic Goods Administration (TGA) 3-year Overall Survival data and biomarker data as approvable CMA endpoints
- Phase 3 trial design alignment achieved between FDA, EMA, MHRA and TGA
- Advanced Therapy Medicinal Product (ATMP) designation granted by EMA triggering Rolling Review in Europe
- Patent filed for OST-HER2 pharmacodynamic response biomarker
- Dr. Craig Eagle appointed Chief Medical Advisor
- Dr. Robert Langer appointed as Strategic Advisor
- Publication of four articles in Drug Discovery World
- Publication of statistically significant 2-year Overall Survival (
20% vs.1% , p = 0.00995) for OST-HER2 plus radiation in frontline unresected canine osteosarcoma vs. radiation-alone
Third Quarter 2026 Highlights to Date
- Appointed Dr. Craig Eagle to the Board of Directors
- Type C Statistical Methods Meeting scheduled with FDA for mid-September 2026
- Statistical Methods SAM scheduled with MHRA expected in September 2026
- FDA grants Biomarker Qualification Program Meeting, expected in September 2026
- Conference call reviewed biomarker pharmacodynamic response data being used as a surrogate clinical efficacy endpoint to support CMAAs and BLA requests
- Submission of regulatory dossier to U.S. Department of Agriculture (USDA) for OST-HER2 in canine osteosarcoma by wholly owned subsidiary OS Animal Health
Expected Remaining Second Half 2026 Milestones
- Interim 3-year Overall Survival data
- Type C Statistical Methods Meeting with FDA in mid-September 2026
- Statistical Methods SAM scheduled with MHRA in mid-September 2026
- FDA Biomarker Qualification Program (BQP) Meeting
- Full 3-year Overall Survival data
- Submission of the Clinical Trial Notification (CTN) to MHRA in preparation for initiation of confirmatory Phase 3 Metastatic Osteosarcoma Program.
- Receipt of at least
$3 million in cash from VAT refund by OST U.K. - Formal submission for at least
$4.2 million in reimbursable R&D Tax Credit by OST U.K. - Acceptance of OS Animal Health regulatory submission by USDA followed by meeting
- Complete submission of BLA request to FDA
- Complete submission of CMAA requests to MHRA, EMA and TGA
- FDA decisions on Regenerative Medicine Advanced Therapy (RMAT), Breakthrough Therapy Designation and Commissioner's National Priority Review Voucher (CNPV)
- Initiation of confirmatory Phase 3 trial in the U.K.
- FDA decision on BLA request under Accelerated Approval Program
- EMA decision on CMAA request
- MHRA decision on MAA request
- TGA decision on MAA request
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 August 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 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 Advanced Therapy Medicinal Products (ATMP) from the European Medicines Agency.
The Company reported positive data in its Phase 2b clinical trial of OST-HER2 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 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 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 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 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. 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, the Company's expectations regarding its cash runway; the timing, amount and receipt of VAT refunds and R&D tax credits; the Company's ability to obtain additional financing on acceptable terms or at all; the timing and outcome of regulatory submissions and potential approval of OST-HER2 by the U.S. Food and Drug Administration 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 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/309887