What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2025-11-10 compared with 2025-08-11 · 121 added, 106 removed, 549 unchanged (29% of the section changed)

3 unchanged sentences

(Amounts in thousands, except for share amounts)

September 30,

Current assets:

17 unchanged sentences

Preferred stock, $ 0.0001 par value;

10,000,000 shares authorized as of June 30, 2025 and December 31, 2024;

no shares issued and outstanding as of June 30, 2025 and December 31, 2024.

10,000,000 shares authorized as of September 30, 2025 and December 31, 2024;

no shares issued and outstanding as of September 30, 2025 and December 31, 2024.

Common stock, $ 0.0001 par value;

490,000,000 shares authorized as of June 30, 2025 and December 31, 2024;

68,627,886 and 74,312,608 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively.

490,000,000 shares authorized as of September 30, 2025 and December 31, 2024;

68,652,730 and 74,312,608 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively.

Additional paid-in capital

7 unchanged sentences

(Amounts in thousands, except for share and per share amounts)

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Operating expenses:

5 unchanged sentences

Interest income

Other income (loss)

Total other income

1 unchanged sentence

Weighted average shares used to compute net loss per share, basic and diluted²

¹ The amounts for the three and six months ended June 30, 2025 include a one-time milestone payment to Aurigene of $ 10 million.

The amount for the six months ended June 30, 2024 include a one-time milestone payment to Aurigene of $ 5 million.

² The weighted average shares used to compute net loss per share, basic and diluted, include the effect from the pre-funded warrants.

Three Months Ended June 30,

Six Months Ended June 30,

Other comprehensive (loss) gain:

Net unrealized (loss) gain on marketable securities

¹The amounts for the nine months ended September 30, 2025 and 2024 include one-time milestone payments to Aurigene of $ 10,000 and $ 5,000 , respectively.

² For the three and nine months ended September 30, 2025, the weighted average shares used to compute net loss per share, basic and diluted, include the effect from the pre-funded warrants.

Three Months Ended September 30,

Nine Months Ended September 30,

Other comprehensive gain:

Net unrealized gain on marketable securities

Total comprehensive loss

3 unchanged sentences

(Amounts in thousands, except for share amounts)

Three Months Ended June 30, 2025

Three Months Ended September 30, 2025

Comprehensive

Stockholders'

Balances at March 31, 2025

Balances at June 30, 2025

Stock-based compensation expense, including employee stock purchase plan expense

Issuance of shares under employee stock purchase plan

Exercise of stock options

Net unrealized loss on marketable securities

Balances at June 30, 2025

Six Months Ended June 30, 2025

Net unrealized gain on marketable securities

Balances at September 30, 2025

Nine Months Ended September 30, 2025

Comprehensive

7 unchanged sentences

Net unrealized gain on marketable securities

Balances at June 30, 2025

Balances at September 30, 2025

See accompanying notes to the condensed consolidated financial statements.

2 unchanged sentences

(Amounts in thousands, except for share amounts)

Three Months Ended June 30, 2024

Three Months Ended September 30, 2024

Comprehensive

1 unchanged sentence

(Loss) Income

Balances at March 31, 2024

Issuance of shares under at-the-market offering, net of issuance costs of $ 25

Balances at June 30, 2024

Stock-based compensation expense

Issuance of shares under the employee stock purchase plan

Employee stock purchase plan expense

Exercise of stock options

Vesting of restricted stock awards

Net unrealized loss on marketable securities

Balances at June 30, 2024

Six Months Ended June 30, 2024

Net unrealized gain on marketable securities

Balances at September 30, 2024

Nine Months Ended September 30, 2024

Comprehensive

8 unchanged sentences

Vesting of restricted stock awards

Net unrealized loss on marketable securities

Balances at June 30, 2024

Net unrealized gain on marketable securities

Balances at September 30, 2024

See accompanying notes to the condensed consolidated financial statements.

2 unchanged sentences

(Amounts in thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Cash flows from operating activities:

15 unchanged sentences

Purchases of marketable securities

Net cash used in investing activities

Net cash provided by investing activities

Cash flows from financing activities:

Issuance of shares under at-the-market offering, net of issuance costs of $ 166

Issuance costs for shares issued under 2024 equity private placement

Issuance costs for shares issued under 2024 private placement

Proceeds from borrowings under Credit Facility (Note 11)

1 unchanged sentence

Proceeds from exercise of stock options

Net cash provided by (used in) financing activities

Net cash (used in) provided by financing activities

Net decrease in cash and cash equivalents

2 unchanged sentences

Supplemental disclosure of cash flow information

Exchange of common stock for pre-funded warrants

Right-of-use asset obtained in exchange for operating lease liabilities

8 unchanged sentences

In addition to its lead product candidate, Olema is developing a potent KAT6 inhibitor (OP-3136).

The Company is located in San Francisco, California and was incorporated in Delaware on August 7, 2006, under the legal name of CombiThera, Inc.

and on March 25, 2009, was renamed Olema Pharmaceuticals, Inc.

The Company is located in San Francisco, California and was incorporated in Delaware on August 7, 2006 under the legal name of CombiThera, Inc., and on March 25, 2009, was renamed Olema Pharmaceuticals, Inc.

The Company’s principal operations are based in San Francisco, California, and it has operations in Cambridge, Massachusetts.

5 unchanged sentences

Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

The Company had $ 361.9 million of cash, cash equivalents and marketable securities at June 30, 2025, in addition to an available balance of $ 22.0 million under the Loan and Security Agreement dated as of September 5, 2023 (the “Original Loan Agreement”), by and between the Company, as borrower, and Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (the “Bank”), as amended by the First Amendment to Loan and Security Agreement, dated June 28, 2024, by and between the Company and the Bank (the "First Amendment"), as further amended by the Second Amendment to Loan and Security Agreement, dated June 27, 2025 by and between the Company and the Bank (the "Second Amendment" and, collectively with the First Amendment and the Original Loan Agreement, the "Loan Agreement").

The Company had $ 329.0 million of cash, cash equivalents and marketable securities at September 30, 2025, in addition to an available balance of $ 22.0 million under the Loan and Security Agreement dated as of September 5, 2023 (the “Original Loan Agreement”), by and between the Company, as borrower, and Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (the “Bank”), as amended by the First Amendment to Loan and Security Agreement, dated June 28, 2024, by and between the Company and the Bank (the "First Amendment"), as further amended by the Second Amendment to Loan and Security Agreement, dated June 27, 2025 by and between the Company and the Bank (the "Second Amendment" and, collectively with the First Amendment and the Original Loan Agreement, the "Loan Agreement").

Refer to Note 11.

4 unchanged sentences

The 2025 Sales Agreement replaces the prior sales agreement entered into between the Company and Cowen and Company, LLC dated January 5, 2024 (the "2024 Sales Agreement").

During the year ended December 31, 2024, the Company issued 1,772,278 shares of its common stock under the 2024 Sales Agreement at a weighted average price of $ 13.19 for net proceeds of $ 22.8 million after deducting related

issuance costs.

During the year ended December 31, 2024, the Company issued 1,772,278 shares of its common stock under the 2024

Sales Agreement at a weighted average price of $ 13.19 for net proceeds of $ 22.8 million after deducting related issuance costs.

The sales of the 2025 ATM Shares will be made by any method permitted that is deemed to be an "at-the-market" equity offering as defined in Rule 415(a)(4) promulgated under the Securities Act, including sales made directly on or through the Nasdaq Global Select Market.

The Company has agreed to pay TD Cowen a commission of up to 3.0 % of the aggregate gross proceeds from any 2025 ATM Shares sold by TD Cowen.

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

As of June 30, 2025, $ 150.0 million remained available for issuance under the 2025 Sales Agreement.

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

As of September 30, 2025, $ 150.0 million remained available for issuance under the 2025 Sales Agreement.

Private Placement

20 unchanged sentences

Unaudited Interim Financial Information

The interim condensed consolidated balance sheet as of June 30, 2025, the statements of operations and comprehensive loss, and stockholders’ equity for the three and six months ended June 30, 2025 and 2024, and the statements of cash flows for the six months ended June 30, 2025 and 2024 are unaudited.

The interim condensed consolidated balance sheet as of September 30, 2025, the statements of operations and comprehensive loss, and stockholders’ equity for the three and nine months ended September 30, 2025 and 2024, and the statements of cash flows for the nine months ended September 30, 2025 and 2024 are unaudited.

The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed consolidated financial statements included in this report.

The financial data and the other information disclosed in these notes to the condensed consolidated financial statements related to the three- and six-month periods are also unaudited.

The financial data and the other information disclosed in these notes to the condensed consolidated financial statements related to the three- and nine-month periods are also unaudited.

The results of operations presented in these unaudited condensed consolidated financial statements are not necessarily indicative of the results to be expected for the year ending December 31, 2025, or for any other future annual or interim period.

9 unchanged sentences

Cash and cash equivalents are defined as short-term, highly liquid investments with original maturities of 90 days or fewer at the date of purchase.

Cash deposits are all in reputable financial institutions in the United States as of June 30, 2025, and December 31, 2024.

Cash deposits are all in reputable financial institutions in the United States as of September 30, 2025, and December 31, 2024.

Cash and cash equivalents primarily consisted of cash on deposit with U.S.

12 unchanged sentences

For debt securities in an unrealized loss position that do not meet the aforementioned criteria, the Company assesses whether the decline in the fair value of such debt securities has resulted from credit losses or other factors.

The Company considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the securities, among

other factors.

The Company considers the extent to which fair value is less than amortized cost, any changes to the

rating of the security by a rating agency, and any adverse conditions specifically related to the securities, among other factors.

If this assessment indicates that a credit loss may exist, the Company then compares the present value of cash flows expected to be collected from such securities to their amortized cost basis.

28 unchanged sentences

The exercise of these options is at the Company’s discretion.

The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise such options.

For any lease

modification, the Company reassesses the lease classification, remeasures the related lease liability using an updated discount rate that reflects the modified lease term, and adjusts the related ROU asset under the lease modification guidance under Topic 842.

The Company’s lease terms may include options to extend or

terminate the lease when it is reasonably certain that the Company will exercise such options.

For any lease modification, the Company reassesses the lease classification, remeasures the related lease liability using an updated discount rate that reflects the modified lease term, and adjusts the related ROU asset under the lease modification guidance under Topic 842.

The Company has operating leases for its research and development and office facilities.

9 unchanged sentences

These costs are recorded within research and development expenses in the condensed consolidated statements of operations and include personnel expenses, stock-based compensation expenses, allocated general and administrative expenses, and external costs including fees paid to consultants and contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), in connection with non-clinical studies and clinical trials, and other related clinical trial fees, such as for investigator fees, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis.

Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses and other current assets.

Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as either prepaid expenses and other current assets or other assets and long-term deposits.

Such amounts are recognized as an expense as the goods are delivered or the related services are performed.

10 unchanged sentences

The Company capitalizes certain costs incurred for the development and implementation of computer software for internal use.

These costs generally relate to the implementation of the third-party developed software for the Company's regulatory and quality purposes.

These costs generally relate to the implementation of the third-party developed software for the Company's clinical development purposes.

The Company capitalizes these costs when it is determined that it is probable that the project will be completed and the software will be used to perform the function intended, and the preliminary project stage is completed.

15 unchanged sentences

For awards with graded vesting, in which specified tranches of the options vest on different dates, the Company uses a single weighted average expected life to value the entire award, which is equal to the average of the weighted average vesting period of the award and the contractual term of the award.

Equity instruments issued to nonemployees are recorded at their fair value on the grant date and without subsequent remeasurement.

The amount of stock-based compensation expense recognized during a period is based on the value of the portion of the awards that are ultimately expected to vest, including awards with graded vesting.

17 unchanged sentences

The pre-funded warrants are immediately exercisable at an exercise price of $ 0.0001 per share of the Company's common stock, subject to beneficial ownership limitations.

the pre-funded warrants is virtually assured because the underlying common shares will be issued for nominal cash consideration, or at an exercise price of $ 0.0001 per share.

All necessary conditions for issuance of the underlying common shares were met when the pre-funded warrants were issued, and as such, related pre-funded warrants shares were included in the denominator for both the basic and diluted earnings per share calculations.

Exercise of the pre-funded warrants is virtually assured because the underlying common shares will be issued for nominal cash consideration or at an exercise price of $ 0.0001 per share.

All necessary conditions for issuance of the

underlying common shares were met when the pre-funded warrants were issued, and as such, related pre-funded warrants shares were included in the denominator for both the basic and diluted earnings per share calculations.

Refer to Note 12.

3 unchanged sentences

Diluted net loss per common share is computed by adjusting net loss to reallocate undistributed earnings based on the potential impact of dilutive securities, and by dividing the diluted net loss by the weighted average number of common shares outstanding for the period, including the pre-funded warrants shares and potential dilutive common shares.

For purpose of this calculation, outstanding stock options, including unvested restricted stock awards, unvested performance-based restricted stock unit awards and contingently issuable common stock related to the ESPP are considered potential dilutive common shares.

For purpose of this calculation, outstanding stock options, including unvested performance-based restricted stock unit awards and contingently issuable common stock related to the ESPP are considered potential dilutive common shares.

Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive.

19 unchanged sentences

• Level 3 — Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

June 30, 2025

September 30, 2025

(in thousands)

13 unchanged sentences

Government-sponsored enterprise securities

June 30, 2025

September 30, 2025

(in thousands)

14 unchanged sentences

For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses.

There were no marketable securities that had been in a consecutive loss position for more than 12 months as of June 30, 2025.

During the three and six months ended June 30, 2025, the Company did not recognize any other-than-temporary impairment loss.

As of June 30, 2025, there was no allowance for losses on available-for-sale debt securities attributable to credit risk.

As of June 30, 2025, all of the Company’s cash and cash equivalents primarily consisted of cash on deposit with U.S.

There were no marketable securities that had been in a consecutive loss position for more than 12 months as of September 30, 2025.

During the three and nine months ended September 30, 2025, the Company did not recognize any other-than-temporary impairment loss.

As of September 30, 2025, there was no allowance for losses on available-for-sale debt securities attributable to credit risk.

As of September 30, 2025, all of the Company’s cash and cash equivalents primarily consisted of cash on deposit with U.S.

banks denominated in U.S.

2 unchanged sentences

Prepaid expenses and other current assets consisted of the following (in thousands):

September 30,

Interest receivable

Prepaid clinical development costs

Value added tax receivable

Prepaid subscriptions and licenses

Value added tax receivable

Prepaid insurance

Prepaid clinical development costs

Other Assets and Long-Term Deposits

Other assets and long-term deposits consisted of the following (in thousands):

September 30,

Clinical development project deposits

4 unchanged sentences

Accrued and other current liabilities consisted of the following (in thousands):

September 30,

Accrued research and development related costs

2 unchanged sentences

Accrued payroll related costs

Accrued taxes

Stock-Based Compensation

22 unchanged sentences

For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options.

The expected term of stock options granted to nonemployees is equal to the contractual term of the option award.

The risk-free interest rate is determined by reference to the U.S.

2 unchanged sentences

The assumptions that the Company used to determine the estimated grant-date fair value of stock options granted to employees and directors under the 2020 Plan and the 2022 Inducement Plan were as follows, presented as a weighted average:

September 30,

Risk-free interest rate

7 unchanged sentences

Forfeited and cancelled

Outstanding as of June 30, 2025

Options vested and exercisable as of June 30, 2025

Options expected to vest as of June 30, 2025

Outstanding as of September 30, 2025

Options vested and exercisable as of September 30, 2025

Options expected to vest as of September 30, 2025

2020 Employee Stock Purchase Plan

8 unchanged sentences

The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock offered under the ESPP.

Stock-based compensation expense related to the ESPP w as $ 0.2 million for each of the three-month periods ended June 30, 2025 and 2024, and $ 0.4 million for each of the six-month periods ended June 30, 2025 and 2024 .

Stock-based compensation expense related to the ESPP w as $ 0.1 million for each of the three-month periods ended September 30, 2025 and 2024, and $ 0.5 million and $ 0.4 million for the nine months ended September 30, 2025 and 2024, respectively .

Stock-Based Compensation Expense

Stock-based compensation expense related to awards granted under the 2014 Plan, the 2020 Plan, the ESPP and the 2022 Inducement Plan was classified in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Research and development

3 unchanged sentences

Basic and diluted net loss per common share was calculated as follows (in thousands, except share and per share amounts):

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Weighted average shares used to compute net loss per share, basic and diluted¹

Net loss per share, basic and diluted

¹ The weighted average shares used to compute net loss per share, basic and diluted, include the effect from the pre-funded warrants.

¹ For the three and nine months ended September 30, 2025, the weighted average shares used to compute net loss per share, basic and diluted, include the effect from the pre-funded warrants.

The potentially dilutive shares that were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented are as follows:

Six Months Ended June 30,

Nine Months Ended September 30,

Options to purchase common stock

Employee stock purchase plan contingently issuable

Unvested performance-based restricted stock unit awards

The Company leases certain of its facilities under non-cancellable operating leases expiring at various dates through 2027.

The Company leases certain of its facilities under non-cancellable operating leases expiring at various dates into 2027.

On December 15, 2020, the Company entered into a lease agreement with Tennieh LLC to lease approximately 9,800 square feet of office and lab space in San Francisco, California (the “Laboratory Lease Agreement”).

16 unchanged sentences

According to the terms of the Cambridge Lease Agreement, the Company paid a less than $ 0.1 million security deposit and is required to pay monthly rent and common area charges.

The following table summarizes total lease expense during the three and six months ended June 30, 2025 and 2024 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

The following table summarizes total lease expense during the three and nine months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Straight-line operating lease expense

1 unchanged sentence

Total operating lease expense

The following table summarizes supplemental cash flow information during the three and six months ended June 30, 2025 and 2024 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

The following table summarizes supplemental cash flow information during the three and nine months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Cash paid for amounts included measurement of lease liabilities:

1 unchanged sentence

Supplemental noncash information on lease liability arising from obtaining a right-use-asset

The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of June 30, 2025 (in thousands):

2025 (from July 2025)

The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of September 30, 2025 (in thousands):

2025 (from October 2025)

Total future minimum lease payments

2 unchanged sentences

Lease liabilities, non-current

The following table summarizes the lease term and discount rate as of June 30:

The following table summarizes the lease term and discount rate as of September 30:

September 30,

Weighted-average remaining lease term (years)

1 unchanged sentence

Commitments and Contingencies

Agreements with Novartis

2024 Clinical Trial Collaboration and Supply Agreement with Novartis

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

Pursuant to the Agreement, Novartis will provide the Company with ribociclib drug supply for the Company’s planned Phase 3 OPERA-02 clinical trial of palazestrant in combination with ribociclib in ER+/HER2- frontline advanced or metastatic breast cancer (the "OPERA-02 trial").

Pursuant to the Agreement, Novartis will provide the Company with ribociclib drug supply for the Company’s Phase 3 OPERA-02 clinical trial of palazestrant in combination with ribociclib in ER+/HER2- frontline advanced or metastatic breast cancer (the "OPERA-02 trial").

Under the Novartis Pharma Agreement, the Company will supply (including manufacturing, packaging and labeling) palazestrant and letrozole for the OPERA-02 trial.

5 unchanged sentences

The Company granted Novartis a right of first negotiation with respect to (a) the grant to any person or entity any right, license or sublicense to exploit palazestrant, in any field or territory, other than to third party service providers, or (b) the sale or other transfer to any person or entity of palazestrant and any related assets (each referred to herein as an "Olema Compound Transaction").

If the Company desires to or does, at any time, (a) solicit or entertain any third party proposal or indication of interest with respect to an Olema Compound Transaction, or (b) negotiate (including in response to any proposal or indication of interest received by the Company), enter into or perform under, in each case, any written definitive agreement with a third party with respect to or that contemplates an Olema Compound Transaction, then the Company must provide written notice to Novartis regarding such Olema Compound Transaction, along with certain other specified information.

notice to Novartis regarding such Olema Compound Transaction, along with certain other specified information.

Novartis will have 30 days after receipt of such notice to elect to enter into exclusive good faith negotiations with respect to such Olema Compound Transaction for a period of up to 120 days .

11 unchanged sentences

The Novartis Pharma Agreement will terminate on the fifth anniversary of the date on which the first dose of palazestrant is administered to the first study subject.

Either party may terminate the Novartis Pharma Agreement for the uncured material breach or insolvency of the other party, for failure to comply with certain anti-corruption obligations, in the event of a change of control of the other party, if it reasonably deems it necessary in order to protect the safety, health or welfare of subjects enrolled in the clinical studies for the combined therapies due to the existence of a material safety issue, if the parties jointly decide that the Olema Combination is not achieving sufficiently superior levels of efficacy, if any regulatory authority action prevents a party (or the Letrozole supplier) from supplying its product, in the event of an unresolved force majeure event,

or in certain circumstances for an unresolved clinical hold with respect to ribociclib, palazestrant or letrozole (or the combination of ribociclib and palazestrant or ribociclib and letrozole).

a party (or the Letrozole supplier) from supplying its product, in the event of an unresolved force majeure event, or in certain circumstances for an unresolved clinical hold with respect to ribociclib, palazestrant or letrozole (or the combination of ribociclib and palazestrant or ribociclib and letrozole).

In addition, Novartis may terminate the Novartis Pharma Agreement if the Company has failed to commence the OPERA-02 trial on or prior to March 31, 2026 or if the Company consummates an Olema Compound Transaction, and the Company may terminate the Novartis Pharma Agreement if the Company terminates the OPERA-02 trial other than due to a material safety issue, efficacy issue, regulatory action or upon a clinical hold.

Costs incurred in connection to the Novartis Pharma Agreement are included in the research and development expense in the accompanying condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025.

Costs incurred in connection with the Novartis Pharma Agreement are included in the research and development expense in the accompanying condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2025.

2020 Clinical Collaboration and Supply Agreement with Novartis

13 unchanged sentences

In addition, Novartis may terminate the Novartis Agreement if certain disputes between the parties are not resolved after following the applicable dispute resolution procedures, and the Company may terminate the Novartis Agreement in the event the Company terminates all clinical trials of the combined therapies other than due to a material safety issue or upon a clinical hold.

Costs associated with research activities performed under the agreement are included in research and development expenses in the accompanying condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025, and 2024, with any reimbursable costs from Novartis reflected as a reduction of such expenses.

Costs associated with research activities performed under the Novartis Agreement are included in research and development expenses in the accompanying condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2025, and 2024, with any reimbursable costs from Novartis reflected as a reduction of such expenses.

The Company had previously incurred the full agreed-upon reimbursement amount.

Agreements with Pfizer

2025 Clinical Trial Collaboration and Supply Agreement with Pfizer

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.

Under the terms of the 2025 Pfizer Agreement, the Company will be responsible for conducting the clinical trial for the combined therapies and Pfizer is responsible for supplying atirmociclib to the Company at no cost to the Company.

As part of the collaboration, the parties granted to each other a non-exclusive, royalty-free license under certain of the parties’ respective patent rights in the combination of atirmociclib and palazestrant to use the parties’ respective study drugs in research and development, solely to the extent reasonably needed for the other party’s activities in the collaboration.

All inventions and data developed in the performance of the clinical trials for the combined therapies (other than those specific to each component study drug), will be jointly owned by the parties.

The Company is responsible for manufacturing, packaging and labeling palazestrant, and for packaging and labeling all drugs used in the clinical trials for the combined therapies.

Pfizer is responsible for manufacturing and delivering to us atirmociclib in such quantities as reasonably needed for the clinical trials for the combined therapies.

The 2025 Pfizer Agreement will terminate upon completion of all activities outlined in the study plan and the relevant protocols.

Either party may terminate the 2025 Pfizer Agreement for the uncured material breach of the other party, if it reasonably deems it necessary in order to protect the safety, health or welfare of subjects enrolled in the clinical trials for the combined therapies due to the existence of a material safety issue, or in certain circumstances for an unresolved clinical hold with respect to either atirmociclib or palazestrant.

In addition, Pfizer may terminate the 2025 Pfizer Agreement if reasonably and in good faith believe that atirmociclib is being used in an unsafe manner, and either party may terminate the 2025 Pfizer Agreement if either party determines to discontinue clinical development for medical, scientific, legal or other reasons.

The 2025 Pfizer Agreement does not grant any right of first negotiation to participate in future clinical trials, and each of the parties retains all rights and ability to evaluate their respective compounds.

Costs incurred in connection with the 2025 Pfizer Agreement are included in the research and development expense in the accompanying condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2025.

2020 Clinical Trial Agreement with Pfizer

6 unchanged sentences

The Pfizer Agreement will terminate upon completion of all activities outlined in the study plan and the relevant protocols.

Either party may terminate the Pfizer Agreement for the uncured material breach of the other party, if it reasonably deems it necessary in order to protect the safety, health or welfare of subjects enrolled in the clinical trials for the combined therapies due to the existence of a material safety issue, or in certain circumstances for an unresolved clinical hold with respect to either IBRANCE® or palazestrant.

Either party may terminate the Pfizer Agreement for the uncured material breach of the other party,

if it reasonably deems it necessary in order to protect the safety, health or welfare of subjects enrolled in the clinical trials for the combined therapies due to the existence of a material safety issue, or in certain circumstances for an unresolved clinical hold with respect to either IBRANCE® or palazestrant.

In addition, either party may terminate the Pfizer Agreement if certain disputes between the parties are not resolved after following the applicable dispute resolution procedures or if either party determines to discontinue clinical development for medical, scientific, legal or other reasons.

The Pfizer Agreement does not grant any right of first negotiation to participate in future clinical trials, and each of the parties retains all rights and ability to evaluate their respective compounds.

Costs incurred in connection to the Pfizer Agreement are included in the research and development expense in the accompanying condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025, and 2024.

Costs incurred in connection with the Pfizer Agreement are included in the research and development expense in the accompanying condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2025, and 2024.

License Agreement with Aurigene

7 unchanged sentences

The term of the Aurigene Agreement will continue until the expiration of the last-to-expire of all payment obligations with respect to all licensed products thereunder, unless terminated earlier in accordance with the terms of the Aurigene Agreement.

The Aurigene Agreement may be terminated (a) by the Company for convenience, in its sole discretion, upon prior written notice to Aurigene, (b) by either the Company or Aurigene

in connection with the other party’s uncured material breach or (c) by either the Company or Aurigene in connection with the insolvency of the other party.

The Aurigene Agreement may be terminated (a) by the Company for convenience, in its sole discretion, upon prior written notice to Aurigene, (b) by either the Company or Aurigene in connection with the other party’s uncured material breach or (c) by either the Company or Aurigene in connection with the insolvency of the other party.

The $ 8.0 million upfront payment was incurred in June 2022.

1 unchanged sentence

Payments due to Aurigene upon or subsequent to regulatory approval will be accrued as a provision to cost of sales in the period when achievement of respective milestone target is probable.

The $ 5.0 million milestone payment related to initiation of the first IND-enabling safety study was incurred and recorded as research and development expenses in the accompanying condensed consolidated statement of operations and comprehensive loss during the six months ended June 30, 2024.

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.

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

Management Services Agreements

1 unchanged sentence

The Company has contractual arrangements in the normal course of business with these parties, however, the contracts with these parties are cancelable generally on reasonable notice within one year and the Company’s obligations under these contracts are primarily based on services performed through termination dates plus certain cancelation charges, if any, as defined in each of the respective agreements.

In addition, these agreements may, from time to time, be subjected to amendments as a result of any change orders executed by the parties.

As of June 30, 2025, the Company did not have material contractual commitments with respect to these arrangements.

In addition, these agreements may, from time

to time, be subjected to amendments as a result of any change orders executed by the parties.

As of September 30, 2025, the Company did not have material contractual commitments with respect to these arrangements.

Contingencies

6 unchanged sentences

The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited.

As of June 30, 2025, the Company had not incurred any material costs as a result of such indemnifications.

As of September 30, 2025, the Company had not incurred any material costs as a result of such indemnifications.

Long-term Borrowing

2 unchanged sentences

The Original Credit Facility was to mature on August 1, 2027 (the "Original Maturity Date").

which the Term Loan A of $ 25 million was immediately available, an additional $ 25 million will become available upon the Company achieving certain milestones related to execution of a first line pivotal Phase 3 clinical trial of palazestrant in combination with ribociclib, and an additional $ 50 million which may be made available upon approval of the Bank, and (ii) extended the Original Maturity Date to July 1, 2028 ("Maturity Date").

On June 28, 2024, the Company entered into the First Amendment, which, among other things, (i) increased the aggregate principal amount of the Original Credit Facility from up to $ 50 million to up to $ 100 million, of which the Term Loan A of $ 25 million was immediately available, an additional $ 25 million will become available upon the Company achieving certain milestones related to execution of a first line pivotal Phase 3 clinical trial of palazestrant in combination with ribociclib, and an additional $ 50 million which may be made available upon approval of the Bank, and (ii) extended the Original Maturity Date to July 1, 2028 ("Maturity Date").

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 .

23 unchanged sentences

and engage in certain transactions with affiliates.

As of June 30, 2025, the Company had drawn $ 3.0 million from the Credit Facility which was recorded at cost and presented as long-term borrow ing on the condensed consolidated balance sheet.

As of September 30, 2025, the Company had drawn $ 3.0 million from the Credit Facility which was recorded at cost and presented as long-term borrow ing on the condensed consolidated balance sheet.

The interest expense was less than $ 0.1 million for the three months and nine months ended September 30, 2025, which was included in other income on the condensed consolidated statements of operations and comprehensive loss.

Pre-Funded Warrants

1 unchanged sentence

Accordingly, the Company recorded the pre-funded warrants as a component of stockholders' equity within additional paid-in capital.

The following table summarizes the pre-funded warrants issued as of June 30, 2025:

The following table summarizes the pre-funded warrants issued as of September 30, 2025:

Expiration Date

5 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements