8-K: OS Therapies Announces Full Year 2024 Financial Results and Provides Business Update

OS Therapies reports its full-year 2024 financial results, highlighting progress with its OST-HER2 clinical trial and strategic initiatives.

Summary

• OS Therapies, a clinical-stage biotechnology company, announced its full-year 2024 financial results and provided a business update.
• The company completed the treatment phase of its Phase 2b clinical trial for OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma.
• OS Therapies also entered into an agreement to acquire listeria monocytogenes (Lm)-based assets from Ayala Pharmaceuticals.
• The company is focused on gaining Biologics Licensing Authorization (BLA) for OST-HER2, which would trigger the issuance of a Priority Review Voucher (PRV).
• The company expects to divest the PRV to generate non-dilutive capital.
• OS Therapies reported a net operating loss of $10.886 million for 2024, compared to a net operating loss of $7.916 million in 2023, with the increase largely due to IPO expenses.
• The company completed a $6 million initial public offering (IPO) and a $6 million private placement.
• OS Therapies expects its cash on hand to last into 2026, through the projected BLA milestone and PRV issuance.
• The company plans to present full clinical data from the OST-HER2 Phase 2b trial at MIB Factor in June 2025.
• A rolling BLA submission is expected to begin thereafter, aiming for regulatory approval by year-end 2025.

Sentiment

Score: 7

Explanation: The sentiment is moderately positive due to the progress in clinical trials, acquisition of new assets, and secured funding. However, the increased net operating loss tempers the overall sentiment.

Positives

• OS Therapies completed the treatment phase of its Phase 2b clinical trial for OST-HER2.
• The company is progressing towards a BLA submission for OST-HER2, with potential for a Priority Review Voucher.
• The acquisition of Lm-based assets from Ayala Pharmaceuticals expands the company's pipeline.
• The company secured $12 million in funding through an IPO and private placement.
• Cash on hand is expected to last into 2026, through the projected BLA milestone and PRV issuance.
• Positive Phase 2b data for OST-HER2 clinical trial in recurrent, fully resected, lung metastatic osteosarcoma.

Negatives

• OS Therapies reported a net operating loss of $10.886 million for 2024, an increase from $7.916 million in 2023.
• The company has historically experienced significant operating losses from 2021 to 2024 due to the OST-HER2 clinical trial.

Risks

• The company's future success depends on the approval of OST-HER2 by the FDA.
• The company's ability to generate revenue depends on successfully divesting the Priority Review Voucher.
• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially.

Future Outlook

OS Therapies anticipates submitting a Biologics Licensing Application (BLA) to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. The company expects cash on hand to last into 2026, through the projected BLA milestone and the related issuance of a PRV by the FDA that they intend to sell.

Management Comments

• '2024 was a transformative year for OS Therapies as we completed our initial public offering and finalized the treatment phase of our Phase 2b clinical trial in the prevention of recurrence in fully resected, lung metastatic osteosarcoma,' said Paul Romness, MPH, Chairman & CEO of OS Therapies.
• Chris Acevedo, Chief Financial Officer of OS Therapies, stated that they expect significantly reduced outlays beginning in the second quarter of 2025 and that they have reduced their burn rate substantially such that they expect cash on hand to last the Company into 2026.

Industry Context

OS Therapies is operating in the competitive cancer immunotherapy and ADC biotechnology space, focusing on rare pediatric indications like osteosarcoma. The company's strategy of pursuing a Priority Review Voucher aligns with industry trends of leveraging regulatory incentives to generate non-dilutive capital.

Comparison to Industry Standards

• The company's focus on osteosarcoma, a rare pediatric cancer, aligns with the industry trend of targeting niche indications with unmet medical needs.
• The company's strategy of developing a cancer immunotherapy biologic drug candidate comprised of HER2 bioengineered form of the Lm is similar to strategies employed by companies such as Aduro Biotech, which also uses Lm-based technology.
• The company's plan to sell the Priority Review Voucher (PRV) is a common practice among companies that receive them, as it provides a significant source of non-dilutive capital.
• The company's net operating loss of $10.886 million in 2024 is comparable to other clinical-stage biotechnology companies of similar size and stage of development.

Stakeholder Impact

• Shareholders: Potential for value creation through BLA approval and PRV sale.
• Patients: Potential for new treatment options for osteosarcoma.
• Employees: Job security and potential for growth within the company.

Next Steps

• Presentation of full clinical data from OST-HER2 Phase 2b osteosarcoma clinical trial at MIB Factor in June 2025.
• Rolling BLA submission expected to begin thereafter.
• Summer 2025 Scientific Advice Meeting (SAM) with MHRA for OST-HER2 osteosarcoma program, ILAP application submission and MHRA Conditional Marketing Authorisation application & decision.
• EMA National Competent Authority Scientific Advice Meeting Request (Medicines Evaluation Board, Netherlands) for OST-HER2 osteosarcoma program, EMA PRIME, EMA-FDA Parallel Scientific Advice application and EMA Conditional Marketing Authorisation application & decision.
• USDA meeting for OST-HER2 canine osteosarcoma program, conditional approval and initiation of pivotal clinical studies in preventive and therapeutic applications of OST-HER2 in osteosarcoma.

Key Dates

Keywords

OST-HER2, osteosarcoma, immunotherapy, BLA, Priority Review Voucher, clinical trial, Ayala Pharmaceuticals, IPO, financial results, cancer