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Standing Risk Factors

  • Going Concern (unchanged) — Filing states that conditions raise substantial doubt about the company's ability to continue as a going concern. The same disclosure appeared in the baseline filing.
NASDAQ: OLMA Olema Pharmaceuticals, Inc. 10-Q

Operating loss widens 40% to $67.2M; OPERA-01 top-line pushed to Q1 2027; $218.5M raised

Filed August 10, 2026 · Period ending June 30, 2026 · Compared to 10-Q Aug 11, 2025 · ~2 min read

Key Financials

SEC XBRL
Metric PriorJun 30, 2025 CurrentJun 30, 2026 Δ
Net income -$43.8M -$63.2M ▼ -44.3%
Diluted EPS -$0.51 -$0.61 ▼ -19.6%
Operating income -$47.9M -$67.2M ▼ -40.4%
Cash & equivalents $52.5M $48.6M ▼ -7.4%
Total assets $382.0M $486.6M ▲ +27.4%

As reported in XBRL by the filer · 10-Q vs 10-Q. Income figures cover the fiscal quarter (not year-to-date); cash & assets are period-end balances. n/m = not meaningful (sign change; a % would mislead). about this table · verify on EDGAR →

Key Number Changes

Cash runway MD&A

Prior filing · verify on EDGAR →

We expect our cash, cash equivalents, and marketable securities as of June 30, 2025, as well as the available balance under the Credit Facility, will enable us to fund our current operating plan for at least the next 12 months from the filing date of these condensed consolidated financial statements.

Current filing · verify on EDGAR →

We expect our cash, cash equivalents, and marketable securities as of June 30, 2026, as well as the available balance under the Credit Facility, will enable us to fund our current operating plan through mid-2028.

Net loss and operating loss MD&A

Prior filing · verify on EDGAR →

Our net losses were $43.8 million and $30.4 million for the three months ended June 30, 2025 and 2024, respectively, and $74.2 million and $61.4 million for the six months ended June 30, 2025 and 2024, respectively.

Current filing · verify on EDGAR →

Our net losses were $116.3 million and $74.2 million for the six months ended June 30, 2026 and 2025, respectively.

R&D expenses MD&A

Prior filing · verify on EDGAR →

Research and development expenses for the six months ended June 30, 2025 were $74.5 million, compared to $59.0 million for the six months ended June 30, 2024. The increase of $15.5 million was primarily related to (i) increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials, (ii) increased spending related to the advancement of OP-3136, (iii) increased personnel-related costs due to higher headcount, and (iv) $5.0 million higher milestone payment to Aurigene, partially offset by a decrease in non-cash stock-based compensation expense of $0.6 million.

Current filing · verify on EDGAR →

Research and development expenses for the six months ended June 30, 2026 increased by $32.5 million, or 44%, compared to the same period in 2025. The increase was primarily attributable to (i) the increased spending on clinical development-related activities as we continued to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, as well as (ii) the increased personnel-related costs, including higher non-cash stock-based compensation expense associated with equity awards granted at higher market prices and increased headcount to support our expanding development activities. These increases were partially offset by the absence of $10.0 million of milestone expense related to Aurigene in 2026 that was recognized in the same period in 2025.

G&A expenses MD&A

Prior filing · verify on EDGAR →

General and administrative expenses for the six months ended June 30, 2025 were $8.2 million compared to $8.9 million for the six months ended June 30, 2024. The decrease of $0.7 million was primarily related to a decrease in non-cash stock-based compensation expense of $0.9 million, partially offset by increased spending on corporate-related costs.

Current filing · verify on EDGAR →

General and administrative expenses for the six months ended June 30, 2026 increased by $9.9 million, or 121%, compared to the same period in 2025. The increase was primarily attributable to (i) a $5.5 million increase in non-cash stock based compensation expense associated with equity awards granted at higher market prices, (ii) a $2.8 million increase in professional fees associated with build-out of our corporate infrastructure to support the continued growth, and (iii) a $1.1 million increase in payroll related costs related to increased headcount.

Cash, cash equivalents, and marketable securities MD&A

Prior filing · verify on EDGAR →

As of June 30, 2025, we had $361.9 million in cash, cash equivalents and marketable securities and accumulated deficit of $509.3 million.

Current filing · verify on EDGAR →

As of June 30, 2026, we had $461.1 million in cash, cash equivalents and marketable securities and accumulated deficit of $713.8 million.

Aurigene cumulative milestone payments Notes

Prior filing · verify on EDGAR →

The $10.0 million milestone payment related to dosing of the fifth patient in the first Phase 1 study was incurred during the three months ended June 30, 2025 and recognized as research and development expenses in the accompanying condensed consolidated statements of operations and comprehensive loss during the three and six months ended June 30, 2025.

Current filing · verify on EDGAR →

As of June 30, 2026, the Company has incurred $23 million in upfront and clinical development milestone payments under the Aurigene Agreement.

5 key changes 4 high relevance 1 standing risk 3 sections

Key Changes

  • high

    OPERA-01 pivotal trial completed enrollment, but top-line results now expected Q1 2027 (previously H2 2026) and commercial launch pushed to 2028 (previously late 2027), representing a ~6-month delay in the lead product timeline.

  • high

    Operating loss widened 40% YoY to $67.2M for the six months ended June 30, 2026, driven by 44% higher R&D spending ($107.0M vs $74.5M) on late-stage palazestrant trials and OP-3136 development, plus 121% higher G&A costs ($18.1M vs $8.2M) for infrastructure build-out.

  • high

    Raised $218.5M gross proceeds via November 2025 follow-on offering (11.5M shares at $19.00) and $41.9M net via ATM sales (1.7M shares at $24.92 avg), extending cash runway to mid-2028 with $461.1M in cash and marketable securities as of June 30, 2026.

  • high

    Presented initial OP-3136 Phase 1 monotherapy data at ASCO 2026 showing favorable tolerability (no dose-limiting toxicities, no treatment-related discontinuations) and anti-tumor activity across multiple solid tumor types; combination data with fulvestrant/palazestrant expected mid-2027.

  • medium

    CEO now serves as both principal executive officer and principal financial officer (prior period had separate CFO), reflecting a change in executive structure.

Summary

Olema Pharmaceuticals widened its operating loss 40% YoY to $67.2M for the six months ended June 30, 2026, as R&D spending jumped 44% to $107.0M (driven by late-stage palazestrant trials and OP-3136 development) and G&A costs more than doubled to $18.1M (infrastructure build-out for anticipated commercialization).

The pivotal Phase 3 OPERA-01 trial for palazestrant monotherapy completed enrollment but top-line results slipped from H2 2026 to Q1 2027, pushing commercial launch to 2028—a roughly six-month delay in the lead asset timeline. OPERA-02 (palazestrant + ribociclib in frontline MBC) initiated and is enrolling under the Novartis collaboration.

The company strengthened its balance sheet through a $218.5M gross follow-on offering in November 2025 (11.5M shares at $19.00) and $41.9M in ATM sales during the first half of 2026 (1.7M shares at $24.92 avg). Cash, cash equivalents, and marketable securities stood at $461.1M as of June 30, 2026, extending the runway to mid-2028. OP-3136 delivered encouraging initial Phase 1 monotherapy data at ASCO 2026 (well-tolerated, anti-tumor activity across multiple solid tumors), with combination data expected mid-2027 and a new Bayer collaboration to test OP-3136 + darolutamide in prostate cancer launching Q4 2026. Watch for OPERA-01 top-line results in Q1 2027 and OP-3136 combination data mid-2027. The OPERA-01 delay is the key near-term risk; successful readout would validate the lead asset and support the 2027 NDA filing, while further slippage or negative data would pressure the timeline and valuation.

Section-by-Section Diff

Controls

~65,100 words (+3% vs prior)

Controls effective; CEO now also serves as CFO (prior period had separate CFO); no material changes to internal controls.

1 Modified
Substantive Edit Principal executive/financial officer roles medium

Previous filing · verify on EDGAR →

management, with the participation of our Chief Executive Officer and Chief Financial Officer, performed an evaluation

Current filing · verify on EDGAR →

management, with the participation of our Chief Executive Officer (our principal executive officer and principal financial officer), performed an evaluation

The current filing indicates the CEO now also serves as principal financial officer, whereas the baseline period had a separate CFO. This reflects a change in executive structure, with one individual now holding both roles.

MD&A

~10,200 words (+4% vs prior)

Operating loss widened 40% YoY; OPERA-01 top-line results pushed to Q1 2027; OP-3136 Phase 1 data presented; $204.8M follow-on offering completed Nov 2025.

3 Added 1 Removed 5 Modified 5 Numbers
Substantive Edit OPERA-01 timeline high

Previous filing · verify on EDGAR →

We anticipate top-line results for this trial in the second half of 2026, expect to submit the New Drug Application in 2027, and anticipate U.S. Food and Drug Administration (FDA) approval and commercial launch in late 2027.

Current filing · verify on EDGAR →

We have completed enrollment and anticipate top-line results for this trial in the first quarter of 2027, expect to submit the new drug application (NDA) in 2027, and, if successful, anticipate potential U.S. Food and Drug Administration (FDA) approval and commercial launch in 2028.

The pivotal Phase 3 OPERA-01 trial has completed enrollment, but top-line results are now expected in Q1 2027 (previously H2 2026), and commercial launch is now anticipated in 2028 (previously late 2027). This represents a roughly six-month delay in the development timeline for palazestrant monotherapy, the company's lead product candidate.

Substantive Edit OPERA-02 timeline medium

Previous filing · verify on EDGAR →

The execution of OPERA-02 will be supported by our clinical trial collaboration and supply agreement with Novartis Pharma AG (collectively, with affiliated entities, Novartis), entered into in November 2024 (Novartis Pharma Agreement). Under the terms of the Novartis Pharma Agreement, Novartis will provide Olema with ribociclib drug supply for OPERA-02. In the second quarter of 2025, 90mg of once-daily palazestrant was selected as the dose for OPERA-02. We expect to initiate OPERA-02 in the third quarter of 2025, anticipate top-line data in 2028, and anticipate potential approval and commercial launch in the frontline MBC setting in the U.S. in 2029.

Current filing · verify on EDGAR →

The execution of OPERA-02 is supported by our clinical trial collaboration and supply agreement with Novartis Pharma AG (Novartis), which was announced in December 2024. Under the terms of the agreement, Novartis is providing Olema with ribociclib drug supply for the OPERA-02 trial, which initiated in 2025 and is currently enrolling patients.

OPERA-02 (palazestrant + ribociclib in frontline ER+/HER2- MBC) has initiated and is enrolling patients. The Novartis collaboration agreement date was updated from November 2024 to December 2024. The current filing confirms the trial is underway but does not repeat the 2028 top-line data or 2029 approval timeline stated in the baseline.

Added OP-3136 Phase 1 initial data high

Added in current filing · verify on EDGAR →

At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, we presented encouraging initial clinical data from the monotherapy arm of the OP-3136 Phase 1 study. These data showed OP-3136 monotherapy was well-tolerated, with no dose-limiting toxicities observed and no discontinuations due to treatment-related adverse events, and showed evidence of anti-tumor activity across multiple solid tumor types at multiple dose levels. We anticipate presenting initial combination data from the Phase 1 clinical study of OP-3136 in combination with fulvestrant or palazestrant in mid-2027.

The company presented initial Phase 1 clinical data for OP-3136 at ASCO 2026, showing favorable tolerability (no dose-limiting toxicities, no treatment-related discontinuations) and evidence of anti-tumor activity across multiple solid tumor types. Combination data with fulvestrant or palazestrant are expected mid-2027. This is the first clinical validation of the OP-3136 program.

Added OP-3136 Bayer collaboration medium

Added in current filing · verify on EDGAR →

Furthermore, in May 2026, we announced a clinical trial collaboration and supply agreement with Bayer AG (Bayer) to evaluate the safety, tolerability, and preliminary anti-tumor activity OP-3136 in combination with NUBEQA® (darolutamide), Bayer’s androgen receptor inhibitor, in approximately 36 patients with metastatic castration-resistant prostate cancer. This new combination arm in the ongoing OP-3136 Phase 1 study is expected to initiate in the fourth quarter of 2026.

Olema entered into a clinical trial collaboration with Bayer in May 2026 to evaluate OP-3136 in combination with darolutamide (NUBEQA) in metastatic castration-resistant prostate cancer. The new combination arm is expected to start in Q4 2026. This expands OP-3136's development into prostate cancer, a new indication beyond breast cancer.

Added November 2025 follow-on offering high

Added in current filing · verify on EDGAR →

On November 19, 2025, we completed a follow-on public offering pursuant to which we sold 11,500,000 shares of common stock at a public offering price of $19.00 per share, including 1,500,000 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares, resulting in aggregate net proceeds of $204.8 million, after deducting underwriting discounts and commissions and estimated offering costs.

The company completed a follow-on public offering in November 2025, raising $204.8 million in net proceeds by selling 11.5 million shares at $19.00 per share. This significantly strengthens the balance sheet and extends the cash runway.

Substantive Edit ATM program expansion and activity medium

Previous filing · verify on EDGAR →

On January 6, 2025, we entered into a sales agreement (the 2025 Sales Agreement) with TD Securities (USA) LLC, (TD Cowen) as sales agent, pursuant to which the Company may offer and sell, from time to time, shares of the Company's common stock, having an aggregate offering price of up to $150.0 million (the 2025 ATM Shares). ... There were no sales under the 2025 Sales Agreement during the six months ended June 30, 2025 and as of June 30, 2025, $150.0 million remained available for issuance under the 2025 Sales Agreement.

Current filing · verify on EDGAR →

On January 6, 2025, we entered into a sales agreement (the Original 2025 Sales Agreement) with TD Securities (USA) LLC (TD Cowen), as sales agent, pursuant to which the Company may offer and sell, from time to time, shares of the Company's common stock, having an aggregate offering price of up to $150.0 million (the Original 2025 ATM Shares). ... On December 11, 2025, we entered into amendment no. 1 to the sales agreement (together with the Original 2025 Sales Agreement, the 2025 Sales Agreement), which increased the maximum aggregate offering price under the ATM program to $200.0 million (the 2025 ATM Shares). During the six months ended June 30, 2026, we issued 1,712,739 shares of our common stock under the 2025 Sales Agreement at a weighted-average price of $24.92 for net proceeds of $41.9 million after deducting related issuance costs.

The ATM program was expanded from $150M to $200M in December 2025. During the six months ended June 30, 2026, the company sold 1.7 million shares under the ATM at an average price of $24.92, raising $41.9 million in net proceeds. No ATM sales occurred in the prior-year period.

Substantive Edit Credit Facility amendments medium

Previous filing · verify on EDGAR →

On June 27, 2025, we entered into a Second Amendment to Loan and Security Agreement (the Second Amendment, and the Original Loan Agreement, as amended by the First Amendment, the Credit Facility) with the Bank, which, among other things, (i) decreased the interest rate to a floating rate equal to the greater of 6.0% or the prime rate, and (ii) extended the draw period of Term Loan A to January 15, 2026.

Current filing · verify on EDGAR →

On January 11, 2026, we entered into the Third Amendment to Loan and Security Agreement (the Third Amendment), which, among other things, (i) extended the draw period of Term Loan A to January 31, 2027, (ii) extended the draw period of Term Loan B to January 31, 2027, (iii) extended the draw period of Term Loan C to January 31, 2027, and (iv) extended the Maturity Date to January 1, 2029 (Maturity Date). ... On July 1, 2026, the Company entered into the Fourth Amendment to Loan and Security Agreement (the Fourth Amendment, together with the Original Loan Agreement, as amended by the First Amendment, the Second Amendment, and the Third Amendment, the Loan Agreement), which, among other things, added Olema Oncology International Limited as a secured guarantor under the Loan Agreement.

The company executed two additional amendments to its credit facility: the Third Amendment (January 2026) extended all draw periods to January 31, 2027 and the maturity date to January 1, 2029; the Fourth Amendment (July 2026) added Olema Oncology International Limited as a secured guarantor. These amendments provide additional flexibility and extend the availability of the $100M facility.

Number Change Cash runway high

Previous filing · verify on EDGAR →

We expect our cash, cash equivalents, and marketable securities as of June 30, 2025, as well as the available balance under the Credit Facility, will enable us to fund our current operating plan for at least the next 12 months from the filing date of these condensed consolidated financial statements.

Current filing · verify on EDGAR →

We expect our cash, cash equivalents, and marketable securities as of June 30, 2026, as well as the available balance under the Credit Facility, will enable us to fund our current operating plan through mid-2028.

The company now projects its cash runway extends through mid-2028, a significant improvement from the prior-year disclosure of "at least the next 12 months." This reflects the $204.8M follow-on offering in November 2025 and $41.9M in ATM proceeds during the six months ended June 30, 2026.

Number Change Net loss and operating loss high

Previous filing · verify on EDGAR →

Our net losses were $43.8 million and $30.4 million for the three months ended June 30, 2025 and 2024, respectively, and $74.2 million and $61.4 million for the six months ended June 30, 2025 and 2024, respectively.

Current filing · verify on EDGAR →

Our net losses were $116.3 million and $74.2 million for the six months ended June 30, 2026 and 2025, respectively.

Net loss for the six months ended June 30, 2026 was $116.3 million, up 57% from $74.2 million in the prior-year period. The increase reflects higher R&D spending on OPERA-01, OPERA-02, and OP-3136, as well as increased stock-based compensation and G&A costs to support late-stage development and anticipated commercialization.

Number Change R&D expenses high

Previous filing · verify on EDGAR →

Research and development expenses for the six months ended June 30, 2025 were $74.5 million, compared to $59.0 million for the six months ended June 30, 2024. The increase of $15.5 million was primarily related to (i) increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials, (ii) increased spending related to the advancement of OP-3136, (iii) increased personnel-related costs due to higher headcount, and (iv) $5.0 million higher milestone payment to Aurigene, partially offset by a decrease in non-cash stock-based compensation expense of $0.6 million.

Current filing · verify on EDGAR →

Research and development expenses for the six months ended June 30, 2026 increased by $32.5 million, or 44%, compared to the same period in 2025. The increase was primarily attributable to (i) the increased spending on clinical development-related activities as we continued to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, as well as (ii) the increased personnel-related costs, including higher non-cash stock-based compensation expense associated with equity awards granted at higher market prices and increased headcount to support our expanding development activities. These increases were partially offset by the absence of $10.0 million of milestone expense related to Aurigene in 2026 that was recognized in the same period in 2025.

R&D expenses for the six months ended June 30, 2026 were $107.0 million, up 44% from $74.5 million in the prior-year period. The increase reflects higher clinical development spending (CRO/CMO costs up $25.7M), increased personnel costs, and higher stock-based compensation, partially offset by the absence of a $10M Aurigene milestone in 2026 (vs. $10M in 2025). The prior-year period included a $10M milestone; the year before that included a $5M milestone.

Number Change G&A expenses medium

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General and administrative expenses for the six months ended June 30, 2025 were $8.2 million compared to $8.9 million for the six months ended June 30, 2024. The decrease of $0.7 million was primarily related to a decrease in non-cash stock-based compensation expense of $0.9 million, partially offset by increased spending on corporate-related costs.

Current filing · verify on EDGAR →

General and administrative expenses for the six months ended June 30, 2026 increased by $9.9 million, or 121%, compared to the same period in 2025. The increase was primarily attributable to (i) a $5.5 million increase in non-cash stock based compensation expense associated with equity awards granted at higher market prices, (ii) a $2.8 million increase in professional fees associated with build-out of our corporate infrastructure to support the continued growth, and (iii) a $1.1 million increase in payroll related costs related to increased headcount.

G&A expenses for the six months ended June 30, 2026 were $18.1 million, up 121% from $8.2 million in the prior-year period. The increase was driven by higher stock-based compensation ($5.5M), professional fees ($2.8M), and payroll costs ($1.1M) as the company builds infrastructure to support late-stage development and anticipated commercialization.

Number Change Cash, cash equivalents, and marketable securities high

Previous filing · verify on EDGAR →

As of June 30, 2025, we had $361.9 million in cash, cash equivalents and marketable securities and accumulated deficit of $509.3 million.

Current filing · verify on EDGAR →

As of June 30, 2026, we had $461.1 million in cash, cash equivalents and marketable securities and accumulated deficit of $713.8 million.

Cash, cash equivalents, and marketable securities increased to $461.1 million as of June 30, 2026, up from $361.9 million a year earlier. The increase reflects the $204.8M follow-on offering in November 2025 and $41.9M in ATM proceeds during the six months ended June 30, 2026, partially offset by operating cash burn of $91.9M.

Substantive Edit OP-3136 development timeline medium

Previous filing · verify on EDGAR →

We expect initial clinical results from the OP-3136 Phase 1 study in 2026, potential additional data readout in 2027, and potential initiation of a Phase 3 clinical trial in 2028.

Current filing · verify on EDGAR →

We anticipate presenting initial combination data from the Phase 1 clinical study of OP-3136 in combination with fulvestrant or palazestrant in mid-2027.

The baseline filing projected initial Phase 1 results in 2026, additional data in 2027, and potential Phase 3 initiation in 2028. The current filing confirms initial monotherapy data were presented at ASCO 2026 and combination data are expected mid-2027. The Phase 3 initiation timeline (2028) is not repeated in the current filing.

Show 1 minor / wording change
Removed OP-3136 market potential estimate low

Removed from previous filing · verify on EDGAR →

Based on our internal estimates, we believe that the current global market potential for OP-3136 in the second/third-line ER+/HER2- metastatic breast cancer market is approximately $5 billion.

The baseline filing included an internal estimate of OP-3136's global market potential in second/third-line ER+/HER2- MBC at approximately $5 billion. This estimate does not appear in the current filing. The removal may reflect a shift in disclosure strategy following the presentation of initial Phase 1 data, or a decision to avoid forward-looking market-size statements.

Notes

~20,600 words (+21% vs prior)

Added new Irish subsidiary, new Pfizer/Bayer collaborations, follow-on offering, ATM sales, warrant exercises, and expanded credit facility amendments.

5 Added 3 Modified 1 Numbers
Added Irish subsidiary formation medium

Added in current filing · verify on EDGAR →

Olema Oncology International Limited, incorporated on December 11, 2025 under the laws of Ireland, are wholly-owned subsidiaries of the Company

The company established a new wholly-owned subsidiary in Ireland in December 2025. This is the first disclosure of this entity, which was added as a secured guarantor under the credit facility in July 2026.

Added Follow-on public offering high

Added in current filing · verify on EDGAR →

On November 19, 2025, the Company completed a follow-on public offering pursuant to which it issued and sold 11,500,000 shares of its common stock at a public offering price of $19.00 per share, including 1,500,000 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares, resulting in aggregate net proceeds of $204.8 million, after deducting underwriting discounts and commissions and estimated offering costs.

The company raised $204.8 million net proceeds through a follow-on offering in November 2025, issuing 11.5 million shares at $19.00 per share. This was a significant capital raise not present in the prior-year period.

Substantive Edit ATM offering activity high

Previous filing · verify on EDGAR →

There were no sales under the 2025 Sales Agreement during the three and six months ended June 30, 2025.

Current filing · verify on EDGAR →

During the six months ended June 30, 2026, the Company issued 1,712,739 of the Company's common stock under the 2025 Sales Agreement at a weighted-average price of $24.92 for net proceeds of $41.9 million after deducting related issuance costs.

The company utilized its ATM facility in the first half of 2026, raising $41.9 million by selling 1.7 million shares at an average price of $24.92. In the prior-year period, there were no ATM sales. The 2025 Sales Agreement was also amended in December 2025 to increase capacity from $150M to $200M.

Added Pre-funded warrant exercises medium

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During the six months ended June 30, 2026, partial pre-funded warrants were exercised in exchange for 3.5 million shares of the Company's common shares.

3.5 million pre-funded warrants were exercised during the first half of 2026, reducing outstanding warrants from 17.1 million to 13.6 million. This conversion increased common shares outstanding without raising new cash (warrants were already paid for).

Added Pfizer atirmociclib collaboration medium

Added in current filing · verify on EDGAR →

In September 2025, the Company announced that it entered into a non-exclusive clinical trial collaboration and supply agreement with Pfizer Inc. (“Pfizer”) (the “2025 Pfizer Agreement”), to evaluate the safety and tolerability of palazestrant in combination with Pfizer’s proprietary investigative selective CDK4 inhibitor atirmociclib in patients with metastatic ER+, HER2- breast cancer in a Phase 1b/2 clinical trial.

The company entered a new collaboration with Pfizer in September 2025 to test palazestrant with atirmociclib (a selective CDK4 inhibitor). This is distinct from the existing 2020 Pfizer agreement for palbociclib, expanding the combination-therapy development portfolio.

Added Bayer darolutamide collaboration high

Added in current filing · verify on EDGAR →

In May 2026, the Company entered into a new clinical trial collaboration and supply agreement with Bayer Consumer Care AG ("Bayer") (the "2026 Bayer Agreement") to evaluate, in a Phase 1b/2 study, the safety, tolerability, and preliminary anti-tumor activity of OP-3136 in combination with NUBEQA® (darolutamide), Bayer’s androgen receptor inhibitor, in approximately 36 patients with metastatic castration-resistant prostate cancer. The clinical trial is expected to initiate in the fourth quarter of 2026.

The company announced a new collaboration with Bayer in May 2026 to test OP-3136 (its KAT6 inhibitor) with darolutamide in prostate cancer. This is the first disclosed collaboration for OP-3136 and represents expansion into prostate cancer indications, with trial initiation expected in Q4 2026.

Substantive Edit Credit facility amendments and extensions medium

Previous filing · verify on EDGAR →

On June 27, 2025, the Company entered into the Second Amendment (the Original Credit Facility, as amended, the "Credit Facility"), which, among other things, (i) decreased the interest rate to a floating rate equal to the greater of 6.0% or the prime rate, and (ii) extended the draw period for the Term Loan A to January 15, 2026.

Current filing · verify on EDGAR →

On January 11, 2026, the Company entered into the Third Amendment, which, among other things, (i) extended the draw period of Term Loan A to January 31, 2027, (ii) extended the draw period of Term Loan B to January 31, 2027, (iii) extended the draw period of Term Loan C to January 31, 2027, and (iv) extended the maturity date to January 1, 2029 ("Maturity Date"). Based on the occurrence of specified (a) development milestones related to the pivotal Phase 3 OPERA-01 clinical trial of palazestrant or (b) receipt of proceeds from capital financing, the draw period of Term Loan B and Term Loan C may be further extended to July 31, 2027, and the Maturity Date may be further extended to July 1, 2029. On July 1, 2026, the Company entered into the Fourth Amendment, which, among other things, added Olema Oncology International Limited as a secured guarantor under the Loan Agreement.

The credit facility was amended twice more since the prior period: the Third Amendment (January 2026) extended all draw periods to January 2027 and pushed maturity to January 2029, with conditional extensions to mid-2027/mid-2029 based on milestones or financing. The Fourth Amendment (July 2026) added the Irish subsidiary as a guarantor. These amendments provide extended access to the undrawn $97M facility.

Show 2 minor / wording changes
Substantive Edit Novartis agreement naming and structure low

Previous filing · verify on EDGAR →

On November 29, 2024, the Company entered into a Clinical Trial Collaboration and Supply Agreement (the "Novartis Pharma Agreement") with Novartis Pharma AG

Current filing · verify on EDGAR →

On November 29, 2024, the Company entered into a Clinical Trial Collaboration and Supply Agreement (the "2024 Novartis Agreement") with Novartis Pharma AG

The November 2024 Novartis agreement is now referred to as the "2024 Novartis Agreement" (previously "Novartis Pharma Agreement"). The substantive terms remain unchanged; this is a nomenclature update for consistency with the separate 2020 Novartis Agreement.

Number Change Aurigene cumulative milestone payments low

Previous filing · verify on EDGAR →

The $10.0 million milestone payment related to dosing of the fifth patient in the first Phase 1 study was incurred during the three months ended June 30, 2025 and recognized as research and development expenses in the accompanying condensed consolidated statements of operations and comprehensive loss during the three and six months ended June 30, 2025.

Current filing · verify on EDGAR →

As of June 30, 2026, the Company has incurred $23 million in upfront and clinical development milestone payments under the Aurigene Agreement.

Cumulative Aurigene payments reached $23 million by June 30, 2026 (up from $8M upfront + $5M + $10M = $23M disclosed through Q2 2025). No new milestone was triggered in the current period; this is a cumulative-total disclosure added for the first time.

Financial Statements

Primary statements from SEC XBRL (companyfacts). Labels and figures as reported — not generated by the model.

SEC XBRL

Consolidated Statements of Operations (Unaudited)

Description Q2 ended Jun 30, 2026 Q2 ended Jun 30, 2025
Operating expenses:
Research and development 57.8 43.9
General and administrative 9.4 4.0
Total operating expenses 67.2 47.9
Operating income (67.2) (47.9)
Other income/(expense), net 4.0 4.1
Net income (63.2) (43.8)
Basic earnings per share (0.61) (0.51)
Diluted earnings per share (0.61) (0.51)

Consolidated Balance Sheets (Unaudited)

Description Jun 30, 2026 Jun 30, 2025
Current assets:
Cash and equivalents 48.6 52.5
Short-term investments 412.5 309.4
Prepaid expenses and other current assets 8.8 5.8
Total current assets 469.9 367.7
Property, plant and equipment, net 0.4 0.6
Operating lease right-of-use assets, net 0.6 1.7
Deferred income taxes and other assets 0.01
Other long-term assets 15.7 12.0
TOTAL ASSETS 486.6 382.0
Current liabilities:
Accounts payable 1.7 0.9
Current portion of operating lease liabilities 0.7 1.2
Accrued liabilities 50.7 31.1
Income taxes payable 0.02
Total current liabilities 53.0 33.2
Operating lease liabilities 0.6
Other long-term liabilities 3.0 3.0
Total liabilities 56.0 36.8
Shareholders' equity:
Common stock 0.01 0.01
Capital in excess of stated value 1,145 854.2
Accumulated other comprehensive income (loss) (0.9) 0.3
Retained earnings (deficit) (713.8) (509.3)
Total shareholders' equity 430.6 345.2
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY 486.6 382.0

Consolidated Statements of Cash Flows (Unaudited)

Description Six months ended Jun 30, 2026 Six months ended Jun 30, 2025
Operating Activities:
Net cash from operating activities (91.9) (73.9)
Investing Activities:
Net cash from investing activities 45.4 (10.8)
Financing Activities:
Net cash from financing activities 46.8 (2.3)
Net increase/(decrease) in cash 0.3 (87.0)

Amounts in millions USD; EPS as reported. Line labels are presentation-friendly mappings of filer XBRL tags — not a re-audit of the full statements. Use EDGAR for interactive notes and detail. Interactive statements & notes on EDGAR ↗

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Figures/quotes linked to EDGAR · Narrative written by AI · Aug 11, 2026 · How we verify