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Olema Pharmaceuticals, Inc. (OLMA)·Q3 2024 Earnings Summary

Executive Summary

  • Olema reported Q3 2024 net loss of $34.6M, driven by higher R&D/G&A due to late‑stage palazestrant development and advancing OP‑3136; cash, cash equivalents, and marketable securities were $214.8M as of September 30, 2024 .
  • Management underscored upcoming catalysts: updated palazestrant+ribo data at SABCS in December and IND submission for OP‑3136 before year‑end; OPERA‑01 Phase 3 monotherapy continues toward top‑line in 2026 .
  • No quantitative financial guidance or revenue disclosures; the release focused on clinical progress and preclinical data synergies (everolimus, capivasertib, OP‑3136 combinations) .
  • Wall Street consensus (S&P Global) for Q3 2024 EPS and revenue was unavailable at time of request; therefore, beats/misses vs estimates cannot be determined (S&P Global data unavailable).

What Went Well and What Went Wrong

What Went Well

  • Robust preclinical synergy: palazestrant with everolimus and capivasertib showed enhanced tumor suppression; OP‑3136 demonstrated strong anti‑tumor activity alone and synergy in combinations, reinforcing the mechanistic thesis .
  • Clinical execution: OPERA‑01 Phase 3 monotherapy trial continued enrollment on track for 2026 top‑line; initiation of Phase 1b/2 palazestrant+everolimus study supports breadth in combinations .
  • Management confidence: “We remain on track for top‑line readout in 2026…OP‑3136 demonstrated robust anti‑tumor activity…synergy and enhanced anti‑tumor activity in combination with palazestrant” — Sean P. Bohen, CEO .

What Went Wrong

  • Operating expense ramp widened losses: GAAP R&D rose to $33.2M (+70% YoY) and GAAP G&A to $4.4M (vs $3.9M YoY), widening net loss to $34.6M (vs $21.5M YoY) as programs advanced .
  • Non‑GAAP spending also stepped up: Non‑GAAP R&D was $28.9M (vs $16.7M YoY) and Non‑GAAP G&A $3.0M (vs $2.6M YoY), reflecting sustained investment intensity .
  • Lack of financial guidance and no revenue disclosure limits visibility on cash burn trajectory and timing to potential commercialization; the quarter’s materials emphasized clinical milestones rather than P&L guidance .

Financial Results

Key P&L and Cash (YoY, sequential, and estimates context)

MetricQ3 2023Q2 2024Q3 2024Wall Street Consensus
Net Loss ($USD Millions)$21.5 $30.4 $34.6 N/A (S&P Global unavailable)
GAAP R&D Expense ($USD Millions)$19.5 $29.1 $33.2 N/A
GAAP G&A Expense ($USD Millions)$3.9 $4.4 $4.4 N/A
Net Loss per Share ($USD)$(0.48) N/A$(0.60) N/A
Cash, Cash Equivalents & Marketable Securities ($USD Millions)N/A$239.1 $214.8 N/A

Notes:

  • Non‑GAAP R&D $28.9M (Q3 2024) vs $16.7M (Q3 2023); Non‑GAAP G&A $3.0M (Q3 2024) vs $2.6M (Q3 2023) .
  • Interest income: $2.9M (Q3 2024) vs $1.9M (Q3 2023), partially offsetting higher operating expenses .

Operating Structure and KPIs

KPIQ1 2024Q2 2024Q3 2024
GAAP R&D Expense ($USD Millions)$29.9 $29.1 $33.2
Non-GAAP R&D Expense ($USD Millions)$26.5 $24.9 $28.9
GAAP G&A Expense ($USD Millions)$4.5 $4.4 $4.4
Non-GAAP G&A Expense ($USD Millions)$3.0 $2.9 $3.0
Total Operating Expenses ($USD Millions)N/AN/A$37.6
Interest Income ($USD Millions)N/AN/A$2.9
Net Loss ($USD Millions)$31.0 $30.4 $34.6
Weighted Avg Shares (Basic/Diluted)N/AN/A57,262,803
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$249.0 $239.1 $214.8

Segment breakdown: Not applicable; Olema reports consolidated financials without revenue segments .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueQ3 2024 / FY 2024Not providedNot providedMaintained (none provided)
EPSQ3 2024Not providedNot providedMaintained (none provided)
R&D ExpenseQ3/FY 2024Not providedNot providedMaintained (none provided)
G&A ExpenseQ3/FY 2024Not providedNot providedMaintained (none provided)
Cash RunwayFY 2024+Not providedNot providedMaintained (none provided)
Clinical Milestones2024-2026OPERA‑01 ongoingSABCS data (Dec’24); OP‑3136 IND by YE; OPERA‑01 top‑line in 2026Raised specificity on timing

Earnings Call Themes & Trends

Note: No Q3 2024 earnings call transcript was available; themes reflect management’s Q3 press release and prior quarterly updates .

TopicPrevious Mentions (Q1 2024)Previous Mentions (Q2 2024)Current Period (Q3 2024)Trend
Palazestrant + CDK4/6 (ribociclib)Completed 60‑pt enrollment; ESMO data planned Interim ESMO data; well‑tolerated; prelim CBR 85% (13 eligible) Updated Phase 2 data slated for SABCS Dec’24 Continuing positive data maturation
OPERA‑01 (Phase 3 monotherapy)Trial‑in‑progress poster at ASCO Ongoing second/third‑line trial Enrollment advancing; top‑line readout 2026 On‑track execution
New combinations (everolimus, capivasertib)Plan to initiate everolimus combo in Q3 Initiation planned; broader combo strategy Everolimus combo initiated; preclinical synergy with everolimus/capivasertib Execution plus supportive preclinical data
OP‑3136 (KAT6 inhibitor)Candidate nomination; IND planned late 2024 IND‑enabling complete; IND expected late 2024 IND submission expected before YE; Phase 1 start early 2025; strong preclinical synergy Advancing toward first‑in‑human
Capital positionCash $249.0M Cash $239.1M Cash $214.8M Gradual decline with R&D ramp

Management Commentary

  • “The OPERA‑01 Phase 3 clinical trial of palazestrant as a monotherapy…continues to advance and we remain on track for top‑line readout in 2026…OP‑3136…demonstrated robust anti‑tumor activity as a single agent, as well as synergy…These data reinforce our belief in the potential of OP‑3136…” — Sean P. Bohen, M.D., Ph.D., President & CEO .
  • “Building on our earlier studies…this new data demonstrates the potential for OP‑3136 in combination with palazestrant…strong tumor growth inhibition and regression relative to combinations with fulvestrant.” — David C. Myles, Ph.D., Chief Discovery & Non‑Clinical Development Officer .
  • Preclinical findings highlight palazestrant combinability with everolimus/capivasertib and synergy signals supporting continued clinical exploration across targeted pathways .

Q&A Highlights

  • No Q3 2024 earnings call transcript or Q&A was available; management’s press materials emphasized clinical progress and upcoming data/IND events .

Estimates Context

  • S&P Global consensus estimates for Q3 2024 EPS and revenue were unavailable at the time of retrieval due to request limits; thus, comparison to Street estimates and any beat/miss determination cannot be provided (S&P Global data unavailable).

Key Takeaways for Investors

  • Clinical catalysts near term: Updated palazestrant+ribo data at SABCS (Dec’24) and OP‑3136 IND submission before YE could be stock‑moving events; continued OPERA‑01 progress underpins medium‑term value inflection in 2026 .
  • Portfolio breadth: Preclinical synergy with everolimus/capivasertib and OP‑3136 strengthens the combination strategy and may expand addressable populations within ER+ metastatic breast cancer .
  • Expense trajectory: R&D up 70% YoY to $33.2M and net loss $34.6M reflect scale‑up into late‑stage development; interest income partly offsets but cash declined to $214.8M—monitor burn vs milestones .
  • Strategic focus: Lack of financial guidance keeps attention on execution of clinical timelines and data quality; investors should watch for clarity on 2025 development pace and OP‑3136 Phase 1 initiation .
  • Risk factors: Biotech development risks persist (trial timelines, regulatory outcomes); Olema references risk disclosures in its Q3 2024 10‑Q .
  • Positioning: If SABCS data are compelling and IND proceeds on schedule, the narrative likely shifts toward combination potential and pipeline optionality; OPERA‑01 top‑line remains the key medium‑term catalyst .

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