What changed in this filing

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Item 1. Financial Statements

2024-08-06 compared with 2024-05-08 · 116 added, 89 removed, 475 unchanged (30% of the section changed)

21 unchanged sentences

Preferred stock, $ 0.0001 par value;

10,000,000 shares authorized as of March 31, 2024 and December 31, 2023;

no shares issued and outstanding as of March 31, 2024 and December 31, 2023.

10,000,000 shares authorized as of June 30, 2024 and December 31, 2023;

no shares issued and outstanding as of June 30, 2024 and December 31, 2023.

Common stock, $ 0.0001 par value;

490,000,000 shares authorized as of March 31, 2024 and December 31, 2023;

55,932,127 and 55,097,118 shares issued as of March 31, 2024 and December 31, 2023, respectively;

55,867,863 and 54,992,784 shares outstanding as of March 31, 2024 and December 31, 2023, respectively.

490,000,000 shares authorized as of June 30, 2024 and December 31, 2023;

57,258,367 and 55,097,118 shares issued as of June 30, 2024 and December 31, 2023, respectively;

57,246,411 and 54,992,784 shares outstanding as of June 30, 2024 and December 31, 2023, respectively.

Additional paid-in capital

7 unchanged sentences

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

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

Operating expenses:

5 unchanged sentences

Interest income

Other income (expense)

Total other income

1 unchanged sentence

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

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

Other comprehensive (loss) income:

5 unchanged sentences

(Amounts in thousands, except for share amounts)

Three Months Ended June 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

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

Comprehensive

Stockholders'

(Loss) Income

Balances at December 31, 2023

2 unchanged sentences

Exercise of stock options

Issuance of shares under the employee stock purchase plan

Employee stock purchase plan expense

1 unchanged sentence

Net unrealized loss on marketable securities

Balances at March 31, 2024

Balances at June 30, 2024

Olema Pharmaceuticals, Inc.

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

(Amounts in thousands, except for share amounts)

Three Months Ended June 30, 2023

Comprehensive

1 unchanged sentence

(Loss) Income

Balances at December 31, 2022

Balances at March 31, 2023

Stock-based compensation expense

Exercise of stock options

Issuance of shares under the employee stock purchase plan

Employee stock purchase plan expense

Vesting of early exercised stock options

Vesting of restricted stock awards

Exercise of stock options

Net unrealized gain on marketable securities

Balances at June 30, 2023

Six Months Ended June 30, 2023

Comprehensive

Stockholders'

(Loss) Income

Balances at December 31, 2022

Stock-based compensation expense

Exercise of stock options

Issuance of shares under the employee stock purchase plan

Employee stock purchase plan expense

Vesting of early exercised stock options

Vesting of restricted stock awards

Net unrealized gain on marketable securities

Balances at March 31, 2023

Balances at June 30, 2023

See accompanying notes to the condensed consolidated financial statements.

2 unchanged sentences

(Amounts in thousands)

Three Months Ended March 31,

Six Months Ended June 30,

Cash flows from operating activities:

3 unchanged sentences

Non-cash interest income on marketable securities

Loss on sale of equipment

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

14 unchanged sentences

Proceeds from exercise of stock options

Proceeds from issuance of common stock under employee stock purchase plan

Net cash provided by financing activities

11 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.

2 unchanged sentences

The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, successful discovery and development of its product candidates, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, protection of proprietary technology, compliance with governmental regulations, the impact of geopolitical and macroeconomic events discussed in further detail below, the ability to secure additional capital to fund operations and commercial success of its product candidates.

Palazestrant, OP-3136 and any future product candidates the Company may develop will require extensive nonclinical and clinical testing and regulatory approval prior to commercialization.

Palazestrant, OP-3136 and any future product candidates the Company may develop will require extensive non-clinical and clinical testing and regulatory approval prior to commercialization.

These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities.

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 $ 249.0 million of cash, cash equivalents and marketable securities at March 31, 2024 , in addition to an available balance of $ 25.0 million under the Loan and Security Agreement (the “Loan Agreement”), by and between the Company, as borrower, and Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (the “Bank”).

The Company had $ 239.1 million of cash, cash equivalents and marketable securities at June 30, 2024 , in addition to an available balance of $ 25.0 million under the Loan and Security Agreement (the "Original Loan Agreement"), dated September 5, 2023 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 "Amendment," and the Original Loan Agreement as amended by the Amendment, the "Loan Agreement").

See Footnote 10.

Commitments and Contingencies for details.

Management believes that the Company’s cash, cash equivalents, marketable securities, and the amounts available under the Loan Agreement will be sufficient to fund the Company’s current operating plan for at least the next 12 months from the filing date of these condensed consolidated financial statements.

3 unchanged sentences

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

During the three months ended March 31, 2024 , the Company issued 546,326 shares of its common stock under the Sales Agreement at a weighted-average price of $ 15.00 per share for net proceeds of $ 7.9 million

after deducting related issuance costs.

As of March 31, 2024 , approximately $ 141.8 million remained available for issuance under the Sales Agreement.

During the three months ended June 30, 2024 , the Company issued 1,225,952 shares of its common stock under the Sales Agreement at a weighted-average price of $ 12.39 per share for net proceeds of $ 14.9 million after deducting related issuance costs.

During the six months ended June 30, 2024, the Company issued 1,772,278 shares of its common stock under the Sales Agreement at a weighted-average price of $ 13.19 for net proceeds of $ 22.8 million after deducting related issuance costs.

As of June 30, 2024 , approximately $ 126.6 million remained available for issuance under the Sales Agreement.

Impact of Geopolitical and Macroeconomic Events

12 unchanged sentences

Unaudited Interim Financial Information

The interim condensed consolidated balance sheet as of March 31, 2024, and the statements of operations and comprehensive loss, stockholders’ equity and cash flows for the three months ended March 31, 2024 and 2023 are unaudited.

The interim condensed consolidated balance sheet as of June 30, 2024, and the statements of operations and comprehensive loss, and stockholders’ equity for the three and six months ended June 30, 2024 and 2023, and the statements of cash flows for the six months ended June 30, 2024 and 2023 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-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 six-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, 2024, or for any other future annual or interim period.

4 unchanged sentences

The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the condensed consolidated financial statements and reported amounts of expenses during the reporting period.

Significant areas that require management’s estimates include accruals of research and development expenses, including accrual of research contract costs, stock-based compensation assumptions, including the fair value of common stock.

Significant areas that require management’s estimates include accruals of research and development

expenses, including accrual of research contract costs, stock-based compensation assumptions, including the fair value of common stock.

On an ongoing basis, the Company evaluates its estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances.

2 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 March 31, 2024 , and December 31, 2023.

Cash deposits are all in reputable financial institutions in the United States as of June 30, 2024 , and December 31, 2023.

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

26 unchanged sentences

The Company’s future results of operations involve a number of other risks and uncertainties.

Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s current and potential future product candidates, uncertainty of market acceptance of the Company’s product candidates, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships, dependence on key individuals or sole-source suppliers, and geopolitical and macroeconomic factors.

acceptance of the Company’s product candidates, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships, dependence on key individuals or sole-source suppliers, and geopolitical and macroeconomic factors.

The Company’s product candidates require approvals from the U.S.

26 unchanged sentences

Research and development expenses consist of costs incurred to discover, research and develop product candidates.

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 nonclinical 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.

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.

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

28 unchanged sentences

Income and expense elements are remeasured to U.S.

dollars using the average exchange rates in effect

during the period.

dollars using the average exchange rates in effect during the period.

Remeasurement gains and losses are recorded as other income (expense) on the consolidated statements of operations.

9 unchanged sentences

Recent Accounting Pronouncements

There were no new accounting pronouncements that were relevant to the Company as of and for the three months ended March 31, 2024 .

There were no new accounting pronouncements that were relevant to the Company as of and for the three and six months ended June 30, 2024 .

Fair Value Measurement

6 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.

March 31, 2024

June 30, 2024

(in thousands)

13 unchanged sentences

Government-sponsored enterprise securities

March 31, 2024

June 30, 2024

(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 March 31, 2024.

During the three months ended March 31, 2024, the Company did not recognize any other-than-temporary impairment loss.

As of March 31, 2024 , there was no allowance for losses on available-for-sale debt securities attributable to credit risk.

As of March 31, 2024 , all of the Company’s cash and cash equivalents 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 June 30, 2024.

During the three and six months ended June 30, 2024, the Company did not recognize any other-than-temporary impairment loss.

As of June 30, 2024 , there was no allowance for losses on available-for-sale debt securities attributable to credit risk.

As of June 30, 2024 , all of the Company’s cash and cash equivalents consisted of cash on deposit with U.S.

banks denominated in U.

2 unchanged sentences

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

Prepaid insurance

Prepaid clinical development costs

1 unchanged sentence

Prepaid subscriptions and licenses

Prepaid insurance

Reimbursable research and development costs from a collaboration partner

48 unchanged sentences

Exercised (1)

Outstanding as of March 31, 2024

Options vested and exercisable as of March 31, 2024

Options expected to vest as of March 31, 2024

Outstanding as of June 30, 2024

Options vested and exercisable as of June 30, 2024

Options expected to vest as of June 30, 2024

(1) Exercised amount includes shares returned for taxes withheld for exercise and net transactions.

Early Exercise of Stock Options

The terms of the 2014 Plan permit certain option holders to exercise options before their options are vested, subject to certain limitations.

The early exercised options are subject to the same vesting provisions in the original stock option awards.

Shares issued as a result of early exercise that have not vested are subject to repurchase by the Company upon termination of the purchaser’s employment, at the price paid by the purchaser.

Such shares are not deemed to be outstanding for accounting purposes until they vest and are therefore excluded from shares outstanding and from basic and diluted net loss per share until the repurchase right lapses and the shares are no longer subject to the repurchase feature.

A liability is recognized related to the cash proceeds of the unvested options and is reclassified into common stock and additional paid-in capital as the shares vest and the repurchase right lapses.

All early exercised options were vested as of March 31, 2024.

Restricted Stock Awards

The following table summarizes the restricted stock activity under the 2014 Plan during the three months ended March 31, 2024:

The following table summarizes the restricted stock activity under the 2014 Plan during the six months ended June 30, 2024:

Number of Shares

1 unchanged sentence

Unvested restricted stock as of December 31, 2023

Unvested restricted stock as of March 31, 2024

Unvested restricted stock as of June 30, 2024

Performance-Based Restricted Stock Unit Awards

1 unchanged sentence

Pursuant to the terms of the PSUs, 65 % of each PSU vests upon certification by the Compensation Committee of the Company of achieving a pre-determined performance goal by June 30, 2024, and, 35 % of each PSU vests upon certification by the Compensation Committee of the Company of achieving a pre-determined performance goal by June 30, 2024.

In June 2024, pursuant to the terms of the PSUs, the Compensation Committee of the Company approved an extension of the achievement of the performance goal related to the 65 % tranche of the PSUs from June 30, 2024 to December 31, 2024.

Expense recognition for PSUs commences when it is determined that attainment of the performance goal is met.

During the three months ended March 31, 2024 , no performance goal was met, and therefore, no related stock-based compensation expense was recorded.

The following table summarizes the performance-based restricted stock activity under the 2020 plan during the three months ended March 31, 2024:

During the three and six months ended June 30, 2024 , no performance goal was met, and therefore, no related stock-based compensation expense was recorded.

The following table summarizes the performance-based restricted stock activity under the 2020 plan during the six months ended June 30, 2024:

Number of Shares

1 unchanged sentence

Outstanding as of December 31, 2023

Outstanding as of March 31, 2024

Outstanding as of June 30, 2024

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 was $ 0.2 million and $ 0.1 million for the three months ended March 31, 2024 and 2023, respectively.

Stock-based compensation expense related to the ESPP was $ 0.2 million and $ 0.4 million for the three and six months ended June 30, 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 March 31,

Three Months Ended June 30,

Six Months Ended June 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 March 31,

Three Months Ended June 30,

Six Months Ended June 30,

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

1 unchanged sentence

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:

Three Months Ended March 31,

Six Months Ended June 30,

Unvested restricted stock awards

3 unchanged sentences

The Company leases certain of its facilities under non-cancellable operating leases expiring at various dates through 2026.

On June 1, 2013, the Company entered into a management services agreement with MandalMed, Inc.

(the “MandalMed Services Agreement”) to have access to and use a portion of approximately 5,762 square feet of space for the use of laboratory benches, lab equipment, office space, and administrative and facilities services.

The Company subsequently entered into six amendments to extend the agreement term to November 2023.

As part of the sixth amendment, the Company gained access to use additional space of approximately 2,130 square feet for a three year period commencing on December 1, 2020 and ending on November 30, 2023.

This lease was terminated during the fourth quarter of 2023.

According to the terms of the MandalMed Services Agreement, the Company had previously paid a security deposit of less than $ 0.1 million and was required to

pay monthly rent and common area charges.

As of March 31, 2024, this security deposit had been returned to the Company.

On August 27, 2020, the Company entered into a lease agreement with 512 2nd Street LLC to lease approximately 3,500 square feet of office space in San Francisco, California (the “Office Space Lease Agreement”).

The Office Space Lease Agreement was for a period of two years commencing on September 1, 2020 and ending August 31, 2022.

In April 2022, the Company extended the Office Space Lease Agreement up to August 31, 2023 and had one year renewal option to extend the term up to August 31, 2024 .

The Company decided not to exercise the one-year renewal option at the end of the lease term (i.e., August 31, 2023).

According to the terms of the Office Space Lease Agreement, the Company had previously paid a $ 0.1 million security deposit and was required to pay monthly rent and common area charges.

As of March 31, 2024, this security deposit had been returned to the Company.

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”).

10 unchanged sentences

The lease was accounted for under Topic 842 and the Company recorded ROU asset and lease liability of $ 0.7 million and $ 0.7 million, respectively, in the accompanying condensed consolidated financial statements.

The following table summarizes total lease expense during the three months ended March 31, 2024 (in thousands):

Three Months Ended March 31,

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

Three Months Ended June 30,

Six Months Ended June 30,

Straight-line operating lease expense

2 unchanged sentences

Total operating lease expense

The following table summarizes supplemental cash flow information during the three months ended March 31, 2024 (in thousands):

Three Months Ended March 31,

The following table summarizes supplemental cash flow information during the three and six months ended June 30, 2024 and 2023 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Cash paid for amounts included measurement of lease liabilities:

Operating cash flows from operating leases

The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of March 31, 2024 (in thousands):

Years Ended December 31,

2024 (from April 2024)

The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of June 30, 2024 (in thousands):

Years Ending December 31,

2024 (from July 2024)

Total future minimum lease payments

2 unchanged sentences

Lease liabilities, non-current

The following table summarizes lease term and discount rate as of March 31, 2024:

Three Months Ended March 31,

The following table summarizes lease term and discount rate as of June 30, 2024:

Weighted-average remaining lease term (years)

2 unchanged sentences

Loan Agreement

On September 5, 2023, the Company entered into the Loan Agreement by and between the Company and the Bank.

The Loan Agreement provides for a four-year senior secured credit facility in an aggregate principal amount of up to $ 50.0 million (the “Credit Facility”), of which $ 25.0 million became available upon the closing of the Private Placement, and the remaining $ 25.0 million may be made available upon approval of the Bank in its discretion.

The Credit Facility will mature on August 1, 2027 (the “Maturity Date”).

As of March 31, 2024, the Company had not drawn down from the Credit Facility.

On September 5, 2023, the Company entered into the Original Loan Agreement.

The Original Loan Agreement provided for a four-year senior secured credit facility in an aggregate principal amount of up to $ 50.0 million (the “Original Credit Facility”).

On June 28, 2024, the Company entered into the Amendment which amends the Original Loan Agreement in order to, among other things, (i) increase the aggregate principal amount of the Original Credit Facility from up to $ 50.0 million to up to $ 100.0 million (the "Credit Facility"), of which $ 25.0 million is currently available, an additional $ 25.0 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 $ 50.0 million which may be made available upon approval of the Bank in its discretion, and (ii) extend the maturity date to July 1, 2028 (the "Maturity Date").

As of June 30, 2024, the Company had not drawn down funds under the Credit Facility.

The obligations under the Loan Agreement are secured by substantially all of the assets of the Company, subject to limited exceptions.

29 unchanged sentences

The collaboration is focused on the evaluation of the safety, tolerability and efficacy of palazestrant in combination with Novartis’ proprietary CDK4/6 inhibitor Kisqali® (ribociclib) and/or Novartis’ proprietary phosphatidylinositol 3-kinase (“PI3K a ”) Inhibitor Piqray® (alpelisib) (collectively the “Novartis Study Drugs”) as part of the Company’s Phase 1b/2 clinical study of palazestrant in patients with metastatic estrogen receptor-positive breast cancer.

The Novartis Amendment 1, among other things, expanded our clinical collaboration with Novartis, increasing the size of the ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib to approximately 60 patients and Novartis Amendment 2 increased the size of the ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib by an additional 15 patients exploring 90 mg of palazestrant in combination with 600 mg of ribociclib.

Amendment 2 increased the size of the ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib by an additional 15 patients exploring 90 mg of palazestrant in combination with 600 mg of ribociclib.

The Company will be responsible for the conduct of the clinical trials for the combined therapies in accordance with a mutually agreed development plan.

9 unchanged sentences

As of December 31, 2023, the Company had incurred the full agreed-upon reimbursement amount.

As of March 31, 2024 , there was no outstanding balance from the receivable due from Novartis.

As of June 30, 2024 , there was no outstanding balance from the receivable due from Novartis.

Clinical Trial Agreement

7 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 or insolvency 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 the IBRANCE® or palazestrant.

certain circumstances for an unresolved clinical hold with respect to either the 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 months ended March 31, 2024, and 2023.

License Agreement

11 unchanged sentences

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.

As of March 31, 2024 , the $ 5.0 million milestone related to initiation of the first IND-enabling safety study was met and was recorded as research and development expenses in the condensed consolidated financial statements for the three months ended March 31, 2024.

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 three months ended March 31, 2024.

There was no milestone met during the three months ended June 30, 2024.

Management Services Agreements

2 unchanged sentences

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 March 31, 2024, the Company did not have material contractual commitments with respect to these arrangements.

As of June 30, 2024, 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 March 31, 2024 , the Company had not incurred any material costs as a result of such indemnifications.

As of June 30, 2024 , the Company had not incurred any material costs as a result of such indemnifications.

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