OS Therapies Inc (OSTX)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 was an execution-heavy quarter: OS Therapies reported a net operating loss of $3.876M and diluted EPS of -$0.18, driven by one-time costs from closing the Phase 2b trial and regulatory preparation; CFO said these costs are largely behind them with burn rate reduced and runway into mid-2026 .
• EPS missed Wall Street consensus (Primary EPS Consensus Mean -$0.0867 vs actual -$0.18) amid elevated one-time spend; revenue remains pre-revenue ($0), consistent with the company’s status * .
• The company reaffirmed clinical and regulatory momentum: Type D FDA meeting feedback expected mid-June; data presentation at MIB Factor on June 28; on track for Q3 2025 BLA filing for OST-HER2 in recurrent, fully resected, lung metastatic pediatric osteosarcoma .
• Strategic catalysts near term include FDA feedback, Phase 2b data visibility to the community, and BLA timing; management tone was confident about Accelerated Approval prospects and platform consolidation .

What Went Well and What Went Wrong

What Went Well

• Positive Phase 2b clinical data and clear regulatory path: management intends to leverage Phase 2b results to seek Accelerated Approval; key FDA interactions underway and timelines laid out . Quote: “We will be leveraging this data to seek Accelerated Approval from the FDA… We believe we are well positioned to bring the first new treatment for osteosarcoma to market in over 40 years.” — Paul Romness, CEO .
• Platform consolidation and IP protection: the company acquired listeria assets (three clinical stage, eight preclinical) and received a Notice of Allowance for a manufacturing patent extending exclusivity to 2040 .
• Cost normalization outlook: CFO highlighted one-time Q1 expenses largely behind them and a dramatically reduced burn rate, supporting operations into mid-2026 .

What Went Wrong

• EPS missed consensus due to one-time study closure and regulatory prep costs: net operating loss increased YoY to $3.876M from $1.490M; diluted EPS of -$0.18 vs consensus -$0.0867; pre-revenue status persists * .
• YoY operating loss expansion: spend associated with trial close and regulatory ramp increased losses vs Q1 2024, even as share count rose (21.249M vs 5.991M weighted average shares), diluting per-share impacts but lifting absolute loss .
• Limited visibility into near-term revenues: management reiterated pre-revenue positioning, with commercialization dependent on regulatory outcomes and PRV monetization timing .

Financial Results

Values retrieved from S&P Global.*

Values retrieved from S&P Global. EPS miss: actual below consensus. Revenue aligns with pre-revenue status * .

Segment breakdown: not applicable; company is pre-revenue .

Guidance Changes

No quantitative guidance provided for revenue, margins, OpEx, OI&E, tax rate, dividends in Q1 materials .

Earnings Call Themes & Trends

Note: No formal transcript was filed; an archived webcast was referenced by the company .

Management Commentary

• CEO: “We will be leveraging this data to seek Accelerated Approval from the FDA… we have started important interactions with the FDA… We believe we are well positioned to bring the first new treatment for osteosarcoma to market in over 40 years.” — Paul Romness .
• CEO on platform: Consolidated ownership of listeria immunotherapy assets, extending exclusivity into 2040 with a new manufacturing patent .
• CFO: “One-time expenses are now largely behind us, and we have dramatically reduced our burn rate, positioning us to operate into mid-2026.” — Chris Acevedo .

Q&A Highlights

• No formal earnings call transcript was filed for Q1 2025. The company indicated an archived investor update webcast would be available on its website; a YouTube investor update is posted, but no transcript was accessible via filings .
• Guidance clarifications came through the press release: mid-June Type D feedback, June 28 data presentation, Q3 End of Phase 2 meeting, Q3 BLA filing on track .

Estimates Context

• EPS: Q1 2025 actual -$0.18 vs consensus -$0.0867 — bold miss driven by one-time trial closure costs and regulatory prep, as noted by CFO . Values retrieved from S&P Global.*
• Revenue: Consensus and actual both $0.00, consistent with pre-revenue status . Values retrieved from S&P Global.*
• Implications: Near-term estimate revisions likely to reflect lower operating expense run-rate starting Q2 2025, while modeling remains anchored on regulatory timelines and PRV monetization potential rather than product revenues .

Key Takeaways for Investors

• The EPS miss was driven by concentrated one-time costs; management expects a materially lower burn rate from Q2 onward, extending runway into mid-2026 — a key input for cash needs modeling .
• Regulatory cadence is the main stock driver: mid-June FDA feedback, June 28 data presentation, Q3 End of Phase 2 meeting, and a Q3 BLA filing target; execution on these milestones could re-rate regulatory probability-of-success .
• Platform and IP consolidation (listeria assets; manufacturing patent into 2040) strengthen long-term optionality beyond OST-HER2 and may support partnership dialogues, including ADC/tADC BD through OS Drug Conjugates .
• Pre-revenue status persists; near-term non-dilutive capital could come from a PRV upon approval (post-Q3 filing and review), but timing and valuation are exogenous; frame scenarios accordingly .
• International pathways (MHRA Project Orbis alignment; EMA rapporteur planning) add parallel catalysts and potential earlier ex-US access; monitor alignment outcomes .
• Trading lens: Headlines from FDA feedback and the MIB Factor data presentation are likely catalysts; sentiment may hinge on clarity of statistical analysis plans and congruence of EFS/OS endpoints .
• Medium-term thesis: If Accelerated Approval proceeds, focus shifts to commercialization readiness, including manufacturing scale-up and distribution execution, and life-cycle development across indications; pipeline breadth offers optionality .

Additional relevant Q1-period press releases:

• OS Animal Health subsidiary launched to commercialize OST-HER2 for canine osteosarcoma, expanding applications and potential revenue pathways outside human oncology .