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Olema Pharmaceuticals, Inc. (OLMA)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 diluted EPS was -$0.54, with net loss of $30.4M; Olema remains pre-revenue as it advances late-stage oncology programs .
  • R&D spend rose year over year to $29.1M (GAAP) on palazestrant Phase 3 and combination studies plus KAT6 program work; non-GAAP R&D was $24.9M; cash and marketable securities were $239.1M at quarter-end .
  • Management highlighted encouraging palazestrant + ribociclib interim data (clinical benefit rate 85% across 13 eligible patients) and reiterated progress on OPERA-01 (Phase 3) and OP-3136 (KAT6) IND filing planned for late 2024 .
  • No formal financial guidance was provided; liquidity supports at least 12 months of operations from the filing date, and the credit facility was upsized to as much as $100M subject to milestones/approvals, a potential near-term funding backstop .

What Went Well and What Went Wrong

What Went Well

  • Palazestrant + ribociclib combination showed “no new safety signals or enhancement of toxicity” and a preliminary clinical benefit rate of 85% in 13 CBR-eligible patients; management: “The preliminary efficacy data is highly encouraging” (CEO) .
  • Phase 3 OPERA-01 monotherapy trial is ongoing, with top-line results expected in 2026; expanded collaboration with Novartis supports combination pathway preparation .
  • OP-3136 KAT6 program completed IND-enabling studies; IND filing targeted for late 2024, adding pipeline breadth and future optionality .

What Went Wrong

  • Net loss widened YoY to $30.4M (from $20.1M), driven by increased clinical development and KAT6 advancement; GAAP R&D rose to $29.1M (from $18.0M) .
  • Olema remains pre-commercial with zero product revenue; the near-term thesis is fully dependent on clinical execution and milestones rather than financial results .
  • Continued cash burn (operating cash outflow of $51.1M in 1H 2024) underscores funding needs for Phase 3 programs; while liquidity is adequate for at least 12 months, additional capital likely needed longer-term .

Financial Results

P&L Summary vs Prior Year and Prior Quarter

MetricQ2 2023Q1 2024Q2 2024
Revenue ($USD Millions)$0.0 $0.0 $0.0
Net Loss ($USD Millions)$20.1 $31.0 $30.4
Diluted EPS ($USD)-$0.49 -$0.56 -$0.54

Operating Expenses (GAAP)

Metric ($USD Millions)Q2 2023Q1 2024Q2 2024
R&D Expense$18.0 $29.9 $29.1
G&A Expense$3.6 $4.5 $4.4
Total Operating Expenses$21.6 $34.3 $33.5

Operating Expenses (Non-GAAP)

Metric ($USD Millions)Q2 2023Q1 2024Q2 2024
R&D (excl. SBC)$15.0 $26.5 $24.9
G&A (excl. SBC)$2.4 $3.0 $2.9

Balance and Liquidity

Metric ($USD Millions)Q4 2023Q1 2024Q2 2024
Cash, Cash Equivalents & Marketable Securities$261.8 $249.0 $239.1
Total Assets$276.9 $263.7 $254.6
Total Stockholders’ Equity$253.9 $236.3 $227.2

Segment Breakdown

ItemDetail
Reportable SegmentsSingle operating/reportable segment

KPIs (Share and Cash Flow)

KPIQ2 2023Q1 2024Q2 2024
Weighted Avg Shares (Basic/Diluted)40,720,294 55,574,324 56,282,402
Net Cash Used in Operating Activities ($USD Millions, YTD)$(42.5) $(23.5) $(51.1)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial guidance (Revenue, margins, OpEx, OI&E, tax, dividends)FY/Q2 2024None providedNone providedMaintained (no guidance)
Liquidity runway≥12 months from 10-Q filing dateN/AManagement believes cash, marketable securities, and available credit facility fund plan for at least next 12 monthsMaintained
Credit facility capacityOngoing$50M facilityAmended to up to $100M (with $25M available now; $25M upon Phase 3 combo milestones; $50M at bank discretion)Raised

Earnings Call Themes & Trends

Note: We searched for Q2 2024 earnings call transcript and found none available on the company site or common transcript repositories; Olema appears to furnish the 8‑K and 10‑Q without a posted call transcript for Q2 2024. We searched the IR site and major transcript aggregators; no transcript was returned .

TopicPrevious Mentions (Q4 2023 & Q1 2024)Current Period (Q2 2024)Trend
Palazestrant Phase 3 (OPERA-01)Initiated OPERA-01; top-line expected 2026 Ongoing; trial-in-progress poster at ASCO; continued progress Stable execution
Palazestrant combinations (CDK4/6)Interim combo data at SABCS; well-tolerated; dose at RP2D 120 mg with palbociclib/ribociclib ESMO Breast (May): no new safety signals; 85% CBR across 13 patients in ribociclib combo Improving (data maturity)
Everolimus (mTOR) comboPlanned initiation in Q3 2024 Still targeted Q3 2024 initiation On track
KAT6 inhibitor (OP-3136)Candidate nominated; preclinical synergy; IND expected late 2024 IND-enabling studies completed; IND filing targeted late 2024 Advancing
Financing/liquidityATM program launched; $7.9M raised in Q1; $25M credit facility available Cash $239.1M; ATM used in Q2 ($14.9M net); credit facility upsized to up to $100M Strengthened capacity
Macro/geopoliticsMonitoring inflation, rates, conflicts; market volatility risk Similar disclosures; continued monitoring Stable risk disclosure

Management Commentary

  • “The preliminary efficacy data is highly encouraging and we look forward to updating with more mature efficacy.” – Sean P. Bohen, M.D., Ph.D., President & CEO .
  • “The OPERA-01 Phase 3 clinical trial for palazestrant as a monotherapy… is ongoing, and later this year we are looking forward to presenting new data on our KAT6 inhibitor, OP-3136, and filing an IND.” – CEO .

Q&A Highlights

We searched for an earnings call transcript for Q2 2024 but did not find one (company IR and common repositories); therefore, Q&A themes and clarifications are unavailable for this quarter .

Estimates Context

  • We attempted to retrieve S&P Global consensus (EPS and revenue) for Q2 2024, but the data was unavailable due to access limits. As a result, we cannot present vs-consensus comparisons for this quarter. The company reported diluted EPS of -$0.54 and no product revenue for Q2 2024 .

Key Takeaways for Investors

  • Clinical execution drives the thesis: palazestrant + ribociclib interim data (85% CBR) strengthens the combination pathway; OPERA-01 (monotherapy) progress continues toward 2026 top-line readout .
  • Near-term catalysts: initiation of the everolimus combo (Q3 2024), additional palazestrant-CDK4/6 data at a future meeting, and OP-3136 IND filing late 2024; these events can reset sentiment and valuation in absence of revenue .
  • Operating spend is increasing in line with late-stage development; GAAP R&D $29.1M and non-GAAP R&D $24.9M in Q2 underline continued investment—expect ongoing cash burn until pivotal outcomes .
  • Liquidity looks sufficient for at least 12 months, with added flexibility from the credit facility upsized to up to $100M; watch for additional equity usage (ATM) and milestone-triggered debt capacity .
  • With no product revenue and EPS losses, stock reaction will hinge on clinical readouts, safety/tolerability continuity, and regulatory progress rather than financial beats/misses .
  • Focus diligence on OPERA-01 design/assumptions and combination trials’ patient mix and endpoints; any safety or exposure interactions could alter timelines or costs .
  • Risk profile remains typical of clinical-stage biotech: execution, regulatory, funding, and macro risks persist; maintain position sizing consistent with binary clinical outcomes .