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OS Therapies Inc (OSTX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 EPS was -$0.24 versus Wall Street consensus of -$0.14, a miss driven by continued clinical-stage operating costs; revenue remained pre-revenue, with consensus at $0.00* .
  • Management outlined 2025 regulatory milestones: full Phase 2b data in June 2025, a rolling BLA to begin thereafter, and intent to sell an FDA Priority Review Voucher to finance operations; CFO guided materially reduced spend from Q2 2025 and cash runway into 2026 .
  • Liquidity strengthened by a $6.05M private placement closed December 31, 2024, supporting BLA preparation and commercialization readiness for OST-HER2; management reiterated PRV market comp of ~$150M from a recent sale .
  • Strategic acquisition: OS agreed to acquire Ayala’s Lm/HER2 IP, cutting OST-HER2 royalties from 10% to 1.5% and eliminating $20.0M+ in milestones, improving long-term economics .
  • Near-term stock catalysts: full clinical data presentation (June 2025), BLA initiation, PRV monetization strategy, and clarity on MHRA/EMA pathways .

What Went Well and What Went Wrong

What Went Well

  • “2024 was a transformative year… the Company remains primarily focused on gaining a [BLA] for OST-HER2… [and] expects to then divest [the PRV] to capitalize with non-dilutive capital” — CEO Paul Romness .
  • CFO highlighted reduced burn and extended runway: “we expect significantly reduced outlays beginning in the second quarter of 2025… cash on hand to last the Company into 2026” .
  • Financing and commercial readiness: closed $6M private placement and initiated commercial-ready manufacturing ahead of BLA submission .

What Went Wrong

  • EPS missed consensus in Q4 (-$0.24 vs -$0.14*), reflecting ongoing operating losses inherent to a pre-revenue biotech .
  • Operating losses rose Y/Y, with FY 2024 net operating loss of $10.886M vs $7.916M in 2023, largely IPO-related; quarterly Q3 operating loss was $2.875M vs $1.557M in Q2 .
  • Equity issuance constraints from the private placement (issuance limits, variable-rate restrictions) could temper capital-raising flexibility until stockholder approvals and time-based conditions are met .

Financial Results

Note: OS Therapies is a pre-revenue biotechnology company; revenue reporting is not material at this stage .

MetricQ2 2024Q3 2024Q4 2024
Net Operating Loss ($USD Millions)$1.557 $2.875 n/a
Net Loss per Share (EPS, $USD)-$0.26 -$0.18 -$0.24*
Weighted Avg Shares (Millions)5.991 15.897 n/a
Estimates vs Actual (Q4 2024)ConsensusActual
EPS ($USD)-$0.14*-$0.24*
Revenue ($USD Millions)$0.00*n/a

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough 2025Mid-2025 runway post-IPO Into 2026 after reduced burn and $6M financing Raised
Phase 2b Data Disclosure4Q 2024Topline data expected Dec 2024 Full data presentation at MIB Factor in June 2025; positive Phase 2b data noted Refined/Extended
BLA Submission2H 2025Not specifiedRolling BLA expected to begin post-June 2025 presentation New
PRV Monetization2025PRV eligible upon BLA approval Intend to sell PRV; cites recent ~$150M market comp New/Explicit
Manufacturing2025Not specifiedCommercial-ready manufacturing initiated for OST-HER2 New
Regulatory Path (UK/EU)2025Not specifiedMHRA SAM in 3Q 2025; EMA PRIME/Parallel SA requests; conditional authorization pathways New
Canine Program2025Conditional approval notedUSDA meetings, conditional approval and pivotal studies planned Maintained/Operationalized
Capital Structure Constraints1H 2025Not specifiedIssuance/variable-rate restrictions until later of 6 months or stockholder approval New Risk Parameter

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript available in our document set.

TopicQ2 2024 (prior)Q3 2024 (prior)Q4 2024 (current)Trend
Clinical Progress (OST-HER2)Interim data; 41 patients dosed; 21 sites Dosing completed; topline Dec 2024 Positive Phase 2b data; full data June 2025 Advancing to full disclosure
Regulatory Path & PRVRPDD/Fast Track/Orphan; PRV after approval Active FDA discussions on BTD Rolling BLA plan; PRV sale intent More concrete
Financing & RunwayIPO completed; mid-2025 runway —$6.05M private placement; runway into 2026 Strengthened
Manufacturing Readiness——Commercial-ready manufacturing initiated New execution phase
International Regulators——MHRA SAM, EMA PRIME/Parallel SA plans Globalizing pathway
ADC/tADC PlatformTunable ADC candidates referenced tADC platform highlighted tADC/Si-Linker/CAP tech reiterated Sustained
IP/Portfolio Expansion——Agreement to acquire Ayala Lm/HER2 assets Expanded pipeline & improved economics

Management Commentary

  • CEO: “The Company remains primarily focused on gaining a [BLA] for OST-HER2… [triggering] issuance of a Priority Review Voucher (PRV) that the Company expect to then divest… to fully exploit OST-HER2 and the rest of the Lm platform” .
  • CFO: “We expect significantly reduced outlays beginning in the second quarter of 2025… [and] cash on hand to last the Company into 2026” .
  • CEO (Q3): “We… finished dosing the final patient… looking forward to releasing topline data in December and then engaging with the FDA” .
  • CEO (Financing): “If we are successful… the Company would be granted a priority review voucher (PRV)… [most recent] sale price… $150 million” .

Q&A Highlights

There was no earnings call transcript available for Q4 2024; therefore, no Q&A excerpts or clarifications can be provided from a call.

Estimates Context

Coverage remains thin. Q4 2024 EPS consensus mean was -$0.14 versus actual -$0.24 (1 estimate); revenue consensus was $0.00 (3 estimates)*. This suggests near-term EPS may require modest upward loss revisions until burn reduction flows through by Q2 2025, with potential offset from financing and operating spend moderation .

Q4 2024 ConsensusEPSRevenue ($USD Millions)EPS - # of EstimatesRevenue - # of Estimates
S&P Global-$0.14*$0.00*1*3*

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Regulatory momentum: Full Phase 2b data in June 2025 and rolling BLA thereafter are pivotal de-risking milestones that frame the 2025-2026 value-creation timeline .
  • Liquidity improved: $6.05M private placement plus reduced burn from Q2 2025 extends runway into 2026, lowering near-term financing risk .
  • Economics enhanced: Ayala IP acquisition reduces royalties to 1.5% and removes $20.0M+ milestones, materially improving OST-HER2’s commercial profile .
  • PRV monetization optionality: Clear intent to sell PRV post-approval, with recent comp near $150M; proceed value could fund broader pipeline without dilution .
  • Execution watchpoints: Issuance and variable-rate restrictions until stockholder approval/time thresholds; monitor timing of shareholder votes and registration effectiveness .
  • Risk context: PRV program reauthorization uncertainty noted, but company remains eligible based on prior designation and timing for potential approval .
  • Near-term catalysts: June 2025 data, MHRA SAM (3Q 2025), BLA initiation, manufacturing readiness updates; these events likely drive narrative and stock reaction .

Source Documents Read

  • Q4 2024 8-K 2.02 and press release (Full Year 2024 results and business update) .
  • Q3 2024 8-K press release (third quarter update) .
  • Q2 2024 8-K press release (second quarter update) .
  • Private placement pricing and closing 8-Ks (Dec 30/Jan 3) .
  • Asset purchase 8-K (Ayala Lm/HER2 IP) .

No Q4 2024 earnings call transcript was available.