Executive Summary

Q1 2024 was execution-focused: Olema completed enrollment of two 60‑patient Phase 1b/2 palazestrant combination trials (with ribociclib and palbociclib), set an ESMO Breast Congress data update (ribociclib combo) and investor call for May 15, and highlighted OP-3136 (KAT6 inhibitor) with an IND planned for late 2024 .
Financially, cash, cash equivalents and marketable securities were $249.0M; net loss increased to $31.0M, driven by higher clinical spend and a $5.0M Aurigene milestone for KAT6; G&A declined YoY and higher interest income provided a partial offset .
Prior quarters show step‑up in investment: cash was $261.8M at 12/31/23 and $276.9M at 9/30/23; quarterly net losses were $26.8M (Q4) and $21.5M (Q3) as late‑stage programs ramped .
Near‑term catalysts: ESMO combo data and investor call on May 15, OPERA‑01 Phase 3 monotherapy T‑i‑P at ASCO, everolimus combo initiation in Q3 2024, and OP‑3136 IND by late 2024 .
Wall Street consensus (S&P Global) for Q1 2024 EPS/revenue was not retrievable due to access limits at request time; beat/miss vs. estimates cannot be assessed.

What Went Well and What Went Wrong

What Went Well
- Completed enrollment of both 60‑patient Phase 1b/2 combo studies (ribo/palbo), setting up meaningful near‑term readouts; management reinforced conviction that palazestrant can become the “backbone endocrine therapy‑of‑choice” for metastatic breast cancer .
- Cost discipline in G&A: GAAP G&A fell to $4.5M (from $6.8M YoY); non‑GAAP G&A fell to $3.0M (from $5.2M YoY) .
- Pipeline expansion: OP‑3136 (KAT6) nominated; IND planned late 2024; new palazestrant‑ribociclib clinical data planned at ESMO .
What Went Wrong
- Net loss widened to $31.0M vs. $28.3M YoY, primarily from a $5.0M KAT6 milestone and higher clinical development spend as palazestrant moves through late‑stage trials .
- Cash declined sequentially to $249.0M from $261.8M at year‑end and $276.9M at Q3‑end as development progressed .
- No formal product revenue/non‑GAAP profitability metrics to offset spend; S&P Global consensus for EPS/revenue was unavailable, limiting external benchmark comparison.

Financial Results

Metric	Q3 2023	Q4 2023	Q1 2024
Cash, Cash Equivalents & Marketable Securities ($M)	$276.9	$261.8	$249.0
Net Loss ($M)	$21.5	$26.8	$31.0
GAAP R&D Expense ($M)	$19.5	$25.9	$29.9
Non‑GAAP R&D Expense ($M)	$16.7	$23.0	$26.5 (incl. $5.0M milestone; excl. $3.4M SBC)
GAAP G&A Expense ($M)	$3.9	$4.5	$4.5
Non‑GAAP G&A Expense ($M)	$2.6	$3.1	$3.0
EPS (GAAP)	($0.48)	Not disclosed in press release	Not disclosed in press release
Revenue	Not reported (clinical‑stage; no product sales disclosed)	Not reported (press release)	Not reported (press release)

Notes: Non‑GAAP definitions exclude stock‑based compensation; Q1 2024 non‑GAAP R&D includes the $5.0M Aurigene milestone for KAT6 . Q3 2023 EPS is from the statement of operations; Q4 2023 and Q1 2024 press releases did not include per‑share metrics .

Guidance Changes

Metric/Item	Period	Previous Guidance	Current Guidance	Change
Palazestrant + ribociclib interim data	May 2024 (ESMO)	“ESMO Breast Congress 2024” update planned (from FY/Q4 update)	Present interim results at ESMO Breast Congress; investor call May 15, 8:00 a.m. ET	Maintained, with added call details
Palazestrant + everolimus initiation	Q3 2024	Initiate Phase 1b/2 in Q3 2024	Initiate Phase 1b/2 in Q3 2024	Maintained
OP‑3136 (KAT6) IND	Late 2024	File IND in late 2024	IND expected to be filed in late 2024	Maintained
OPERA‑01 Phase 3 monotherapy (top‑line timing)	2026	Top‑line results expected in 2026	OPERA‑01 T‑i‑P at ASCO; no update to top‑line timing in Q1 release	Maintained (no change reiterated)

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3 2023)	Previous Mentions (Q4 2023)	Current Period (Q1 2024)	Trend
R&D execution (OPERA‑01)	Phase 3 monotherapy on track; site activation; first patient targeted Q4 2023	OPERA‑01 initiated; top‑line expected 2026	ASCO T‑i‑P poster for OPERA‑01; program ongoing	Advancing as planned
Combination strategy (CDK4/6)	Rapid enrollment in ribo combo; SABCS updates slated	60‑patient ribo combo fully enrolled; ESMO update planned	Both ribo and palbo 60‑patient studies fully enrolled; ESMO data and call scheduled	On track; near‑term data
New modalities (KAT6)	Preclinical KAT6 data presented (AACR‑NCI‑EORTC)	KAT6 development candidate (OP‑3136) nominated	IND targeted late 2024	Pipeline expanding
Financing/cash	$276.9M cash at Q3; $180M financing (equity + SVB facility) completed	$261.8M cash at YE23	$249.0M cash at 3/31/24	Cash trending down as trials progress
Regulatory/commercial vision	FDA Fast Track noted; backbone therapy ambition	Same; Phase 3 initiation	Reiterated “backbone endocrine therapy‑of‑choice” ambition	Consistent

Note: No Q1 2024 earnings call transcript was available in our document set; Olema scheduled an investor call tied to ESMO data on May 15, 2024 .

Management Commentary

“We believe palazestrant has the potential to become the backbone endocrine therapy‑of‑choice for advanced or metastatic breast cancer, and we look forward to presenting new clinical data in combination with ribociclib at the 2024 ESMO Breast Cancer Annual Congress later this month.” — Sean P. Bohen, President & CEO .
“We have recently completed enrollment in our 60‑patient Phase 2 study of 120 mg palazestrant in combination with 600 mg ribociclib, and we are looking forward to sharing an update on this study at the 2024 ESMO Breast Cancer Annual Congress.” — Sean P. Bohen, President & CEO (FY/Q4 update) .

Q&A Highlights

No formal Q1 2024 earnings call transcript was found in our source set; management planned a dedicated investor webcast for the ESMO Breast Congress palazestrant + ribociclib data on May 15, 2024, 8:00 a.m. ET .

Estimates Context

S&P Global (Capital IQ) consensus for Q1 2024 EPS and revenue was not retrievable at request time due to access limits. As a result, we cannot quantify beats/misses versus consensus for Q1 2024.
Olema did not provide explicit financial guidance (revenue/EPS) and remains a clinical‑stage company without disclosed product revenue; comparisons to estimates are inherently limited to OPEX and cash metrics from company releases .

Key Takeaways for Investors

Execution remains strong heading into pivotal inflections: fully enrolled combo trials, imminent ESMO data (May 15) and ASCO visibility for OPERA‑01 support sustained news flow over the near term .
Expense profile is rising for the right reasons (late‑stage development, $5M KAT6 milestone), while G&A continues to trend lower YoY; monitor burn vs. cash of $249.0M at Q1 end .
The ribociclib combo dataset at ESMO is a key catalyst that can bolster palazestrant’s “backbone therapy” positioning and inform first‑line strategy; the investor call may serve as a stock‑moving event depending on efficacy/tolerability signals .
Pipeline breadth is increasing with OP‑3136 (KAT6) aiming for an IND in late 2024, adding optionality beyond ER targeting while maintaining focus on endocrine‑driven disease .
Absent S&P Global consensus data, trading may hinge more on qualitative catalysts and clinical read‑throughs than on quarterly P&L metrics; focus on efficacy differentiation (mutant and wild‑type ESR1 populations), combinability, and clean safety profile as drivers of sentiment .
Watch for everolimus combo initiation in Q3 2024 and continued clarity around OPERA‑01 timelines; Q4 2023 indicated top‑line in 2026, and this remains the medium‑term value inflection to anchor the thesis .

Citations:

Q1 2024 8‑K 2.02 and press release:
Q4/FY 2023 8‑K 2.02 and press release:
Q3 2023 8‑K 2.02 and press release:

Olema Pharmaceuticals, Inc. (OLMA)·Q1 2024 Earnings Summary