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Investor Relations14 Oct 2025
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OS Therapies (OSTX) investor relations material
OS Therapies Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q2 2025 earnings summary18 Aug, 2025
Executive summary
OST-HER2, the lead candidate for osteosarcoma, advanced to Phase IIb trials with positive FDA feedback and confirmed RMAT criteria, and a BLA number issued in June 2025.
Statistically significant 12-month EFS (35% vs. 20%, p=0.0197) and interim 2-year OS (66.6% vs. 40%, p=0.0046) achieved in Phase 2b trial for OST-HER2.
Completed acquisition of HER2 and listeria immunotherapy assets from Ayala in April 2025, expanding the pipeline and reducing future royalty and milestone obligations.
Commercial partnership with Eversana established for a potential U.S. launch in H1 2026, with logistics and distribution licensing underway.
Raised $7.1 million in PIPE financing and $4.2 million from warrant exercises in the first half of 2025 to support regulatory and pre-commercial activities.
Financial highlights
Net loss of $8.4 million for the six months ended June 30, 2025, compared to $3.0 million for the same period in 2024.
Net operating loss of $4.537 million in Q2 2025, up from $1.557 million in Q2 2024, mainly due to regulatory expenses.
Research and development expenses increased to $3.8 million from $0.8 million year-over-year, driven by clinical trial costs.
General and administrative expenses rose to $6.0 million from $0.7 million, mainly due to marketing, investor relations, and advisory fees.
Cash balance was $2.8 million as of June 30, 2025, down from $5.5 million at year-end 2024.
Outlook and guidance
End of Phase 2 FDA meeting scheduled for August 27, 2025, to enable rolling BLA submission.
BLA submission for OST-HER2 projected to begin in late Q3 2025, with potential U.S. and U.K. approvals as early as year-end 2025.
If BLA is received before September 30, 2026, eligibility for a Priority Review Voucher, potentially worth over $160 million.
Expects operating expenses and losses to increase as clinical and regulatory activities expand.
Current cash and recent financings expected to fund operations for 9–12 months.
Detail plans for funding beyond mid-2026
What is the strategy for the PRV proceeds?
What are the next steps for the acquired pipeline?
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Next OS Therapies earnings date
Q3 202517 Nov, 2025
Next OS Therapies earnings date
Q3 202517 Nov, 2025
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