OS Therapies Inc. 10-Q Summary: Period Ended June 30, 2026
Business Context and Reporting Period
OS Therapies Inc. (OSTX) is a clinical-stage biopharmaceutical company focused on developing treatments for Osteosarcoma, primarily through its lead candidate OST-HER2. The company reported for the quarterly and six-month periods ended June 30, 2026. As of the reporting date, the company had one ongoing clinical trial and is preparing for regulatory submissions to the FDA, EMA, and MHRA. The company is classified as a non-accelerated filer, smaller reporting company, and emerging growth company.
Key Financial Metrics
| Metric | Six Months Ended June 30, 2026 | Six Months Ended June 30, 2025 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(19,029,217) | $(8,413,481) |
| Loss Per Share (Basic & Diluted) | $(0.46) | $(0.35) |
| Cash and Cash Equivalents (End of Period) | $205,035 | $2,802,013 |
| Net Cash Used in Operating Activities | $(10,096,410) | $(5,802,138) |
| Net Cash Provided by Financing Activities | $10,031,615 | $3,537,047 |
| Total Assets | $9,897,313 | $6,839,534 |
| Total Liabilities | $20,741,243 | $11,864,460 |
| Stockholders' Deficit | $(11,914,635) | $(6,095,631) |
Debt and Liquidity: As of June 30, 2026, the company held no outstanding convertible notes (Bridge Notes converted in April 2026). However, current liabilities increased significantly to $20.6 million, driven largely by accounts payable and accrued expenses. The company reported a substantial VAT receivable of $3.1 million recognized in Q2 2026.
Material Changes vs. Prior Period
- Operating Expenses: Research and Development (R&D) expenses surged to $13.4 million for the six months ended June 30, 2026, compared to $3.8 million in the prior year period. This increase was primarily due to vendor expenses for the Phase IIb clinical trial, partially offset by a $1.96 million reduction in R&D expenses resulting from the recognition of a VAT receivable.
- Net Loss: Net loss more than doubled to $19.0 million from $8.4 million year-over-year, driven by increased operational costs and the absence of the $1.4 million gain from the change in fair value of warrant liability recorded in the prior year.
- Balance Sheet: Total liabilities increased by approximately $8.9 million, while total assets grew by $3.1 million, primarily due to the new VAT receivable asset. The company moved from a positive stockholders' equity position in prior years to a deficit of $11.9 million.
- Financing Activity: The company raised approximately $10.0 million in financing activities during the six-month period, including proceeds from a Registered Direct Offering ($4.8 million), warrant exercises ($3.4 million), and bridge financing ($1.8 million).
Outlook, Risks, and Subsequent Events
Going Concern: Management has raised substantial doubt about the company's ability to continue as a going concern. With only $205,035 in cash as of June 30, 2026, and expected vendor costs of approximately $24.0 million for the remainder of 2026, the company is dependent on raising additional capital.
Subsequent Events (Post-June 30, 2026):
- Leonite Settlement: The company settled a secured financing agreement with Leonite Fund I, LP, paying $1.9 million in cash and issuing 500,000 shares of common stock to satisfy the obligation.
- August Private Placement: On August 10, 2026, the company closed the first tranche of a secured note offering, raising $5.0 million in net proceeds. This included the conversion of an August Bridge Note. The notes bear 9.0% interest and are secured by substantially all company assets.
- Regulatory Milestones: The company anticipates submitting a Biologics License Application (BLA) module to the FDA following a Type C meeting in September 2026 and conditional Marketing Authorization Applications to the MHRA and EMA in Q1 2027.
Risks: Significant risks include the potential inability to secure additional financing, the high cost of clinical development, and the restrictive covenants associated with the new Secured Notes, which require 100% of VAT and tax refunds to be used for mandatory prepayments.
Investor Verification Checklist
- Cash Runway: Verify the sufficiency of the $5.0 million raised in August 2026 against the projected $24.0 million in remaining 2026 expenses.
- VAT Receivable Realization: Confirm the collectability of the $3.1 million VAT receivable from HM Revenue & Customs, which significantly impacts the current asset base.
- Debt Covenants: Review the specific negative covenants and mandatory prepayment terms of the August 2026 Secured Notes, particularly regarding the use of future tax refunds.
- Regulatory Timeline: Monitor the outcome of the expected FDA Type C meeting in September 2026 and the subsequent BLA submission.
- Dilution: Assess the impact of outstanding warrants (approx. 15.2 million shares), pre-funded warrants (approx. 3.3 million shares), and convertible notes on future share count.