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Olema Pharmaceuticals, Inc. (OLMA)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 focused on pipeline execution and balance sheet strength: cash, cash equivalents, and marketable securities rose to $434.1M at 12/31/24, bolstered by a $250.0M equity private placement in December; OPERA-01 (Phase 3 monotherapy) remains on track for top-line data in 2026, and OPERA-02 (Phase 3 palazestrant + ribociclib, frontline) is enabled and on track to initiate in 2025 .
  • Net loss was $33.6M in Q4 (vs. $26.8M in 4Q23; QoQ modestly better than $34.6M in Q3), driven by higher clinical development spending (late-stage palazestrant, OP-3136) and lower interest income in the quarter .
  • Clinical momentum: updated SABCS data showed palazestrant + ribociclib delivered a 6-month PFS rate of 73% overall (81% ESR1-mutant, 70% ESR1 wild-type) with a 27% ORR among response‑evaluable patients; safety was consistent with ribociclib + endocrine therapy .
  • Additional catalysts: FDA cleared OP-3136 IND in December and the Phase 1 trial was initiated before year-end; Novartis collaboration secures ribociclib supply for ~1,000-patient OPERA‑02 and supports accelerated execution .

What Went Well and What Went Wrong

  • What Went Well

    • Strong financing and collaboration milestones: $250.0M private placement plus Novartis supply agreement fully enable OPERA‑02 and support key 2025–2026 milestones .
    • Combination data strengthened the case for frontline development: 6‑month PFS rate 73% overall (81% ESR1‑mutant), 27% ORR among response-evaluable; CEO: “data…compelling and highly differentiated” across ESR1 wild-type and mutant after prior CDK4/6i + endocrine therapy .
    • Broadened pipeline execution: OP‑3136 IND cleared in December and the Phase 1 trial initiated/enrolling before year-end, adding an internally discovered epigenetic program to the clinic .

  • What Went Wrong

    • Operating loss elevated YoY from intensified late‑stage spend and lower interest income in Q4; GAAP R&D rose to $32.3M in Q4 (vs. $25.9M 4Q23) and net loss increased YoY to $33.6M (vs. $26.8M) .
    • No quantitative revenue/EPS guidance and no product revenue (clinical-stage) limit near-term financial visibility; company reiterates multi-year clinical timelines (OPERA‑01 topline in 2026) .
    • Earnings call transcript for Q4 was not available in our corpus, limiting insight into Q&A clarifications for modeling; however, Olema did host a SABCS data call on Dec 10 (not the Q4 result) .

Financial Results

Metric (USD)Q2 2024Q3 2024Q4 2024
Cash, Cash Equivalents & Marketable Securities (period-end)$239.1M $214.8M $434.1M
Net Loss$30.4M $34.6M $33.6M
GAAP R&D Expense$29.1M $33.2M $32.3M
Non-GAAP R&D Expense (excl. SBC)$24.9M $28.9M $27.7M
GAAP G&A Expense$4.4M $4.4M $4.5M
Non-GAAP G&A Expense (excl. SBC)$2.9M $3.0M $2.8M

Notes:

  • Q4 net loss increase versus 4Q23 primarily reflected higher clinical/R&D activity for late-stage palazestrant and OP-3136, and lower interest income; QoQ net loss modestly improved vs Q3 .
  • Non-GAAP excludes stock-based compensation; reconciliations provided in company releases .
  • Olema reported no product revenue (clinical-stage; no approved products) .

Segment breakdown and margins: Not applicable; company is pre-commercial with no reported segment revenues .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
OPERA‑01 (Palazestrant monotherapy, 2L/3L mBC) Top‑line2026“Top-line readout in 2026” (Q3: “on track for 2026”) “Top-line data anticipated in 2026” Maintained
OPERA‑02 (Palazestrant + Ribociclib, 1L mBC) Start2025Collaboration and supply agreement announced; initiation expected mid‑2025 “On track for initiation this year (2025)” Maintained (timing affirmed)
OP‑3136 IND/Phase 1Late 2024 / Early 2025IND expected before year-end; Phase 1 to initiate early 2025 IND cleared Dec 9, 2024; Phase 1 initiated and enrolling before year-end 2024 Raised (pulled forward; achieved earlier than prior expectation)
Financial Guidance (Revenue, EPS, Margins, OpEx)2025Not provided (pre‑commercial)Not provided (pre‑commercial)N/A

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
OPERA‑01 executionQ2: Ongoing Phase 3 monotherapy; Q3: advancing, on track for 2026 Reaffirmed; focus on enrollment with 2026 top-line Consistent execution focus
OPERA‑02 (frontline combo)Q2: Not yet specified; Q3: ribociclib combo data to be updated at SABCS Collaboration with Novartis enables OPERA‑02; initiation in 2025 New in Q4 (enabled and scheduled)
Financing & runwayQ2 cash $239.1M; Q3 $214.8M $250.0M private placement; YE cash $434.1M; “well capitalized” Strengthened balance sheet
OP‑3136 (KAT6)Q2: IND-enabling completed; IND in late 2024 IND cleared (Dec 9); Phase 1 initiated/enrolling Advanced into clinic
Palazestrant + ribociclib dataQ2: ESMO interim; CBR 85% across 13 CBR-eligible SABCS update: 6‑mo PFS 73%; ORR 27% among response‑evaluable; safety consistent Data maturity improving

Management Commentary

  • “2024 was a productive year… Bolstered by a strong balance sheet, we are focused on exemplary execution throughout 2025. We plan to advance patient enrollment in… OPERA‑01, initiate… OPERA‑02, continue enrolling OP‑3136, present mature data [palazestrant + ribociclib], and further expand our capabilities…” — Sean P. Bohen, M.D., Ph.D., President & CEO .
  • “We believe these data…are compelling and highly differentiated, with robust clinical activity… regardless of ESR1 status… provide the foundation to initiate OPERA‑02… in front-line metastatic breast cancer next year.” — Sean P. Bohen, M.D., Ph.D. (SABCS update) .
  • “Palazestrant is not an endocrine therapy where you need to wait six months to see a patient derive benefit… well-tolerated with meaningful preliminary efficacy… potential to outperform the current standard of care.” — Virginia Borges, M.D., University of Colorado (PI, combo study) .

Q&A Highlights

  • Earnings call transcript for Q4 2024 was not available in our corpus, so Q&A detail could not be reviewed. Olema hosted a conference call on Dec. 10, 2024 to discuss SABCS combo data (not Q4 results) .

Estimates Context

  • S&P Global consensus for Q4 2024 revenue and EPS was unavailable at time of analysis due to data access limits; as a result, we cannot assess beats/misses versus Street. Values from S&P Global could not be retrieved (SPGI daily request limit exceeded).

KPIs and Clinical/Operational Progress

KPI / MilestoneStatus / ResultSource
Cash, CE & MS (12/31/24)$434.1M
Net Loss (Q4 2024)$33.6M; YoY higher vs $26.8M in 4Q23; QoQ slightly better vs $34.6M in Q3
Palazestrant + Ribociclib (Phase 1b/2)6‑mo PFS 73% overall; 81% ESR1‑mut; 70% ESR1 WT; ORR 27% among response-evaluable; safety consistent with ribociclib + ET
OPERA‑01 (monotherapy)Phase 3 enrolling; topline anticipated in 2026
OPERA‑02 (frontline combo)Enabled via Novartis supply agreement; initiation on track in 2025
OP‑3136 (KAT6)IND cleared Dec 9, 2024; Phase 1 initiated/enrolling before YE 2024

Financial Detail (Non‑GAAP Adjustments)

  • Non‑GAAP R&D (Q4): $27.7M, excluding $4.6M in SBC; GAAP R&D $32.3M .
  • Non‑GAAP G&A (Q4): $2.8M, excluding $1.7M in SBC; GAAP G&A $4.5M .
  • Company provides reconciliations; non‑GAAP measures used for internal planning and comparability; investors should review GAAP/Non-GAAP together .

Key Takeaways for Investors

  • Balance sheet reset lowers financing overhang and enables pivotal expansion: $250M raise + Novartis supply de‑risk OPERA‑02 execution; YE cash $434.1M supports major 2025–2026 milestones .
  • Clinical momentum supports frontline strategy: SABCS combo data (6‑mo PFS 73%; ORR 27%) and multi‑mutational activity (ESR1 mutant and WT) reinforce palazestrant’s potential as a backbone endocrine therapy candidate in combination regimens .
  • 2025 catalysts: OPERA‑02 initiation; maturing combo data; OP‑3136 Phase 1 progress — potential narrative drivers ahead of 2026 OPERA‑01 topline .
  • Spending is elevated by late‑stage trials; investors should watch R&D cadence vs. trial milestones; non‑GAAP exclusions are mainly SBC .
  • Estimate benchmarking unavailable (SPGI access limits); modelers should incorporate pre‑commercial profile (no product revenue) and staged readouts into risk‑adjusted DCF or PoS frameworks .
  • Potential strategic optionality from Novartis agreement (ROFN/negotiation rights on palazestrant transactions) warrants monitoring in any BD/strategic scenarios .

Why Results Looked This Way

  • Net loss increased YoY primarily due to higher clinical development and research spend tied to late‑stage palazestrant and OP‑3136, as well as lower interest income in Q4; non‑GAAP figures show SBC as the main adjustment .
  • Cash increased sharply QoQ from the $250M private placement closing in early December, positioning Olema to fund OPERA‑02 and OP‑3136 alongside OPERA‑01 .

Additional Relevant Q4 2024 Press Releases

  • Novartis clinical trial collaboration and supply agreement + $250M private placement enabling OPERA‑02; “well capitalized” commentary .
  • FDA clearance of OP‑3136 IND; plan to initiate Phase 1 early 2025 (subsequently initiated before year-end) .
  • SABCS updated palazestrant + ribociclib data with favorable activity and tolerability; conference call notice .

Citations: 8‑K/Press Releases/10‑K as referenced in brackets above.