What changed in this filing

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Item 1. Financial Statements

2025-05-13 compared with 2024-11-12 · 192 added, 187 removed, 418 unchanged (48% of the section changed)

3 unchanged sentences

(Amounts in thousands, except for share amounts)

September 30,

Current assets:

16 unchanged sentences

Preferred stock, $ 0.0001 par value;

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

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

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

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

Common stock, $ 0.0001 par value;

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

57,288,319 and 55,097,118 shares issued as of September 30, 2024 and December 31, 2023, respectively;

57,288,319 and 54,992,784 shares outstanding as of September 30, 2024 and December 31, 2023, respectively.

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

68,333,065 and 74,312,608 shares issued as of March 31, 2025 and December 31, 2024, respectively;

68,333,065 and 74,312,608 shares outstanding as of March 31, 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 September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

Operating expenses:

5 unchanged sentences

Interest income

Other income (expense)

Other (loss) income

Total other income

1 unchanged sentence

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

Three Months Ended September 30,

Nine Months Ended September 30,

Other comprehensive income:

Net unrealized gain on marketable securities

Three Months Ended March 31,

Other comprehensive income (loss):

Net unrealized gain (loss) on marketable securities

Total comprehensive loss

3 unchanged sentences

(Amounts in thousands, except for share amounts)

Three Months Ended September 30, 2024

Comprehensive

Stockholders'

(Loss) Income

Balances at June 30, 2024

Stock-based compensation expense

Employee stock purchase plan expense

Exercise of stock options

Net unrealized gain on marketable securities

Balances at September 30, 2024

Nine Months Ended September 30, 2024

Comprehensive

Stockholders'

Balances at December 31, 2024

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

Stock-based compensation expense

Exercise of stock options

Issuance of shares under the employee stock purchase plan

Employee stock purchase plan expense

Vesting of restricted stock awards

Net unrealized gain on marketable securities

Balances at September 30, 2024

Olema Pharmaceuticals, Inc.

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

(Amounts in thousands, except for share amounts)

Three Months Ended September 30, 2023

Comprehensive

Stockholders'

(Loss) Income

Balances at June 30, 2023

Issuance of shares under equity private placement, net of issuance costs of $ 240

Exchange of common stock shares for pre-funded warrants

( 6,070,000 )

Stock-based compensation expense

1 unchanged sentence

Employee stock purchase plan expense

Vesting of early exercised stock options

Vesting of restricted stock awards

Issuance costs for the shares issued under equity private placement

Net unrealized gain on marketable securities

Balances at September 30, 2023

Nine Months Ended September 30, 2023

Balances at March 31, 2025

Comprehensive

Stockholders'

(Loss) Income

Income (Loss)

Balances at December 31, 2023

Issuance of shares under equity private placement, net of issuance costs of $ 240

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

Stock-based compensation expense

Exercise of stock options

Issuance of shares under 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 September 30, 2023

Net unrealized loss on marketable securities

Balances at March 31, 2024

See accompanying notes to the condensed consolidated financial statements.

2 unchanged sentences

(Amounts in thousands)

Nine Months Ended September 30,

Three Months Ended March 31,

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

8 unchanged sentences

Purchase of equipment

Disposal of fixed assets

Maturities of marketable securities

Purchases of marketable securities

Net cash provided by investing activities

Net cash used in investing activities

Cash flows from financing activities:

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

Proceeds from equity private placement, net of issuance costs of $ 240

Issuance costs for shares issued under private placement

Proceeds from exercise of stock options

Proceeds from issuance of common stock under employee stock purchase plan

Net cash provided by financing activities

Net (decrease) increase in cash and cash equivalents

Net decrease in cash and cash equivalents

Cash and cash equivalents at beginning of period

Cash and cash equivalents at end of period

Supplemental disclosure of non-cash financing activity

Exchange of common stock for pre-funded warrants

See accompanying notes to the condensed consolidated financial statements.

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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.

1 unchanged sentence

It operates in one business segment and therefore has only one reportable segment.

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.

The Company is subject to risks and uncertainties common to late-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 non-clinical and clinical testing and regulatory approval prior to commercialization.

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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 $ 214.8 million of cash, cash equivalents and marketable securities at September 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.

The Company had $ 392.7 million of cash, cash equivalents and marketable securities at March 31, 2025, in addition to an available balance of $ 25.0 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 "Amendment," and the Original Loan Agreement as amended by the Amendment, the "Loan Agreement").

Refer to Note 10.

Commitments and Contingencies for further 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.

At-The-Market Offering

On January 5, 2024, the Company entered into a sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“TD Cowen”) as sales agent, pursuant to which the Company may offer and sell, from time to time, shares of our common stock, having an aggregate offering price of up to $ 150.0 million (the “ATM Shares”).

The sales of the 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 of 1933, as amended ("Securities Act"), including sales made directly on or through the Nasdaq Global Select Market.

On January 6, 2025, the Company 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”).

The 2025 Sales Agreement replaces the prior sales agreement entered into between the Company and Cowen and Company, LLC dated as of 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.

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.

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

There were no sales under the 2025 Sales Agreement during the three months ended March 31, 2025.

As of March 31, 2025, $ 150.0 million remained available for issuance under the 2025 Sales Agreement.

Private Placement

On November 29, 2024, the Company entered into a securities purchase agreement for a private placement of (i) 19,928,875 shares of our common stock at a price of $ 9.08 per share and (ii) pre-funded warrants to purchase up to an aggregate of 7,604,163 shares of our common stock at a price of $ 9.0799 per pre-funded warrant, which represents the per share purchase price of the common stock sold in the private placement less the $ 0.0001 per share exercise price for each pre-funded warrant to selected institutional and accredited investors (the 2024 Private Placement).

The aggregate gross proceeds for the 2024 Private Placement were approximately $ 250.0 million.

After deducting offering expenses related to the 2024 Private Placement of approximately $ 13.0 million, the net proceeds to us from the 2024 Private Placement were approximately $ 237.0 million.

Warrant Exchanges

On November 29, 2024 and January 10, 2025, the Company entered into exchange agreements with certain investors and issued to such investors pre-funded warrants to purchase up to 3,420,000 and 6,070,000 shares of the Company's common stock, respectively, in exchange for an equivalent number of shares of the Company's common stock previously outstanding and held by such investors.

The pre-funded warrants were issued without registration under the Securities Act of 1933, as amended (the “Securities Act”), in reliance on the exemption from registration contained in Section 3(a)(9) of the Securities Act.

Refer to Note 11.

Pre-Funded Warrants for further details.

Impact of Geopolitical and Macroeconomic Events

Global economic and business activities continue to face widespread geopolitical and macroeconomic uncertainties, including labor shortages, inflation rates and the responses by central banking authorities to control such inflation, monetary supply shifts and related financial market risks and instability, recession risks, as well as potential disruptions from the Russia-Ukraine conflict and armed conflict between Israel and groups based in surrounding regions, all of which have resulted in volatility in the U.S.

and global financial markets and which have led to, and may continue to lead to, additional disruptions to trade, commerce, pricing stability, credit availability and supply chain continuity globally.

Global economic and business activities continue to face widespread uncertainty related to the geopolitical and macroeconomic environment, generally, including economic uncertainty, market volatility, labor shortages, recent and changing tariff policy announcements, tariffs, trade tensions and retaliatory measures by other countries, supply chain disruptions, the ongoing conflicts between Ukraine and Russia and in the Middle East, as well as any related political or economic responses and counter-responses or otherwise by various global actors, inflationary pressures, monetary supply shifts, increased recession risk, and related financial instability.

The extent of the impact of these factors on the Company’s operational and financial performance, including its ability to execute its business strategies and initiatives in the expected time frame, will depend on future developments, which are uncertain and cannot be predicted.

9 unchanged sentences

Unaudited Interim Financial Information

The interim condensed consolidated balance sheet as of September 30, 2024, and the statements of operations and comprehensive loss, and stockholders’ equity for the three and nine months ended September 30, 2024 and 2023, and the statements of cash flows for the nine months ended September 30, 2024 and 2023 are unaudited.

The interim condensed consolidated balance sheet as of March 31, 2025, and the statements of operations and comprehensive loss, stockholders’ equity and cash flows for the three months ended March 31, 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-month period 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.

5 unchanged sentences

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.

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.

Actual results could differ from those estimates.

1 unchanged sentence

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 September 30, 2024 , and December 31, 2023.

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

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

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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.

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.

11 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.

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

2 unchanged sentences

If the Company were denied approval, approval was delayed or the Company was unable to maintain approval for any product candidate, it could have a materially adverse impact on the Company.

The Company adopted Accounting Standard Update (“ASU”) 2016-12, Leases , Topic 842, (“Topic 842”) as of January 1, 2021.

Under Topic 842, lessees are required to recognize for all leases (with the exception of short-term leases) at the commencement date:

Under Accounting Standards Update ("ASU") 2026-12, Leases, Topic 842, ("Topic 842"), lessees are required to recognize for all leases (with the exception of short-term leases) at the commencement date:

(1) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis;

10 unchanged sentences

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.

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.

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The Company elected to not apply the recognition requirements of Topic 842 to short-term leases with terms of 12 months or less.

Additional information and disclosures required by Topic 842 are contained in Note 11 “Lease” in the Annual Report.

Refer to Note 9.

Lease for further details.

Research and Development Costs

2 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 prepaid expenses and other current assets.

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

Costs incurred in obtaining technology licenses that do not meet the definition of a business are charged immediately to research and development expense if the technology licensed has not reached technological feasibility and has no alternative future uses.

Reimbursements of certain costs associated with research activities performed under the agreement with Novartis Institutes for BioMedical Research, Inc.

(“Novartis”) are recorded as a reduction of research and development expenses and as a receivable due from Novartis, which is recorded under prepaid expenses and other current assets in the accompanying condensed consolidated financial statements, as described in Note 10, Commitments and Contingencies – Clinical Collaboration and Supply Agreement.

Research Contract Costs and Accruals

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The Company’s historical accrual estimates have not been materially different from the actual costs.

Internal-Use Software

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.

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.

Capitalized internal-use software development and implementation costs are included in Other assets and long-term deposits within the consolidated balance sheets.

Capitalized implementation costs are amortized on a straight-line basis over the estimated useful lives of five years .

Costs related to the preliminary project stage, post-implementation, training and maintenance are expensed as incurred.

Comprehensive Loss

Comprehensive loss includes net loss and other comprehensive (loss) gain for each period presented.

Other comprehensive (loss) gain represents net unrealized (loss) gain on marketable securities.

Stock-Based Compensation

Stock-based compensation cost, including grants of stock options and restricted stock awards issued under the Company’s equity incentive plans and ESPP, is measured at the grant date based on the estimated fair value of the award and is recognized as an expense on a straight-line basis over the requisite service period, which is generally the vesting period.

Stock-based compensation cost, including grants of stock options and restricted stock awards issued under the Company’s equity incentive plans and the Company's 2020 Employee Stock Purchase Plan (the "ESPP"), is measured at the grant date based on the estimated fair value of the award and is recognized as an expense on a straight-line basis over the requisite service period, which is generally the vesting period.

Stock-based compensation cost for performance-based restricted stock unit awards issued under the Company’s equity incentive plan is measured at the grant date based on the estimated fair value of the award, which is based on the closing stock price on the grant date, and is recognized as an expense when the Company determines that it is probable that the performance goals will be achieved, which the Company assess on a quarterly basis.

The Company recognizes stock compensation in accordance with ASC 718, Compensation — Stock Compensation (“ASC 718”).

The Company recognizes stock compensation in accordance with Accounting Standards Codification 718, Compensation — Stock Compensation (“ASC 718”).

The Company’s determination of the fair value of stock options with time-based vesting on the date of grant utilizes the Black-Scholes option-pricing model.

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Accordingly, all monetary assets and liabilities of the subsidiary are remeasured into U.S.

the current period-end exchange rates and non-monetary assets are remeasured using historical exchange rates.

dollars at the current period-end exchange rates and non-monetary assets are remeasured using historical exchange rates.

Income and expense elements are remeasured to U.S.

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Changes in the exchange rate between billing dates and payment dates are recorded within other income (expense) on the condensed consolidated statements of operations.

Pre-funded Warrants

The Company issued pre-funded warrants in connection with an equity private placement in 2024 and exchange agreements in November 2024 and January 2025.

The Company accounts for the pre-funded warrants as a freestanding equity-linked financial instrument that met the criteria for equity classification pursuant to Accounting Standards Codification 480, Distinguishing Liabilities from Equity ("ASC 480"), and ASC 815, Derivatives and Hedging ("ASC 815").

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

The Company valued the pre-funded warrants at issuance, concluding that their sales price approximated their fair value.

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 11.

Pre-Funded Warrants for further details.

Net Loss Per Common Share

Basic net loss per common share is computed by dividing the net loss per common share by the weighted average number of common shares outstanding for the period without consideration of common stock equivalents.

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 potential dilutive common shares.

For purpose of this calculation, outstanding stock options, including unvested early exercised options, unvested restricted stock awards, unvested performance-based restricted stock unit awards and contingently issuable common stock related to the 2020 Employee Stock Purchase Plan (the “ESPP”) are considered potential dilutive common shares.

Basic net loss per common share is computed by dividing the net loss per common share by the weighted average number of common shares outstanding for the period, including the pre-funded warrants shares.

For purpose of this calculation, outstanding stock options, including unvested early exercised options, 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.

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.

Recent Accounting Pronouncements

In November 2023, the Financial Accounting Standards Board (the “FASB”) issued ASU No.

2023-07, Segment Reporting (Topic 280) (“ASU 2023-07”).

ASU 2023-07 expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets.

All disclosure requirements under ASU 2023-07 are also required for public entities with a single reportable segment.

The guidance is effective for the fiscal year beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024.

The Company is currently evaluating the impact of this update but does not expect it to have a material impact on its consolidated financial statements and disclosures.

Segment Reporting

The Company's chief operating decision maker (“CODM”), the Chief Executive Officer , manages its business activities as a single operating and reportable segment at the consolidated level.

Accordingly, the Company's CODM uses consolidated net loss to measure segment loss, allocate resources and assess performance.

Further, the CODM reviews and utilizes functional expenses (research and development, and general and administrative) at the consolidated level to manage the Company’s operations.

Other segment items included in consolidated net loss is interest income, which is reflected in the condensed consolidated statements of operations and comprehensive loss.

Recent Accounting Pronouncements Not Yet Adopted

In December 2023, the Financial Accounting Standards Board ("FASB") issued a new income tax-related accounting guidance in Accounting Standards Update ("ASU") 2023-09, Improvements to Income Tax Disclosures.

The standard requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid.

For public business entities, the new requirements will be effective for annual periods beginning after December 15, 2024.

The guidance will be applied on a prospective basis with the option to apply the standard retrospectively.

Early adoption is permitted.

The Company is currently evaluating the impact of the pending adoption of ASU 2023-09 on our consolidated financial statements and related disclosures.

Fair Value Measurement

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• 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.

September 30, 2024

March 31, 2025

(in thousands)

13 unchanged sentences

Government-sponsored enterprise securities

September 30, 2024

March 31, 2025

(in thousands)

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The Company periodically reviews its available-for-sale marketable securities for other-than-temporary impairment.

The Company considers factors such as the duration, severity and the reason for the decline in

value, the potential recovery period and its intent to sell.

The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and its intent to sell.

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 September 30, 2024.

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

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

As of September 30, 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 March 31, 2025.

During the three months ended March 31, 2025, the Company did not recognize any other-than-temporary impairment loss.

As of March 31, 2025, there was no allowance for losses on available-for-sale debt securities attributable to credit risk.

As of March 31, 2025, all of the Company’s cash and cash equivalents consisted of cash on deposit with U.S.

banks denominated in U.

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

September 30,

Prepaid subscriptions and licenses

Prepaid clinical development costs

Interest receivable

Prepaid subscriptions and licenses

Prepaid insurance

Reimbursable research and development costs from a collaboration partner

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

System implementation costs

Property and equipment, net

Security deposits

Office lease deposits

Accrued and Other Current Liabilities

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

September 30,

Accrued research and development related costs

Accrued employee bonuses

Accrued professional fees

Accrued employee bonuses

Accrued payroll related costs

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The 2014 Plan permitted the grant of options and restricted stock awards (including restricted stock purchase rights and restricted stock bonus awards).

The 2014 Plan was terminated on the date the Company’s 2020 Equity Incentive Plan (the “2020 Plan”), which is described

below, became effective, and since that date, no additional awards have been or will be made pursuant to the 2014 Plan.

However, any outstanding awards granted under the 2014 Plan will remain outstanding, subject to the terms of the 2014 Plan award agreements, until such outstanding options are exercised or until any awards terminate or expire by their terms.

The 2014 Plan was terminated on the date the Company’s 2020 Equity Incentive Plan (the “2020 Plan”), which is described below, became effective, and since that date, no additional awards have been or will be made pursuant to the 2014 Plan.

However, any outstanding awards granted under the 2014 Plan remains outstanding, subject to the terms of the 2014 Plan award agreements, until such outstanding options are exercised or until any awards terminate or expire by their terms.

In 2020, the Board and the Company’s stockholders approved and adopted the 2020 Plan.

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Under the 2022 Inducement Plan, initially 2,000,000 shares of common stock were reserved for issuance.

In December 2024, the Compensation Committee of the Board approved an increase of an additional 3,000,000 shares of common stock reserved for issuance under the 2022 Inducement Plan, which increase was made effective as of January 1, 2025.

The 2022 Inducement Plan permits the grant of options, restricted stock awards, stock appreciation rights, restricted stock unit awards, performance awards, and other awards.

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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

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Stock Option Activity

The following table summarizes the stock option activity under the 2014 Plan, the 2020 Plan and the 2022 Inducement Plan:

The following table summarizes the stock option activity under the 2020 Plan and the 2022 Inducement Plan:

(in thousands)

Outstanding as of December 31, 2024

Exercised (1)

Outstanding as of September 30, 2024

Options vested and exercisable as of September 30, 2024

Options expected to vest as of September 30, 2024

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

Restricted Stock Awards

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

Number of Shares

Grant Date Fair Value

Unvested restricted stock as of December 31, 2023

Unvested restricted stock as of September 30, 2024

Performance-Based Restricted Stock Unit Awards

In November 2022, the Company granted to certain employees 710,000 shares of performance-based restricted stock unit awards (the “PSUs”) under the 2020 Plan as consideration for services subject to performance conditions with a fair value based on the closing price of the underlying common stock on the date of grant.

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.

The performance goal related to the 35 % tranche of the PSUs was met and related stock-based compensation expense was recorded in 2023.

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 and nine months ended September 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 nine months ended September 30, 2024:

Number of Shares

Grant Date Fair Value

Outstanding as of December 31, 2023

Outstanding as of September 30, 2024

Outstanding as of March 31, 2025

Options vested and exercisable as of March 31, 2025

Options expected to vest as of March 31, 2025

2020 Employee Stock Purchase Plan

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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 $ 0.1 million and $ 0.4 million for the three and nine months ended September 30, 2024, respectively.

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

Nine Months Ended September 30,

Three Months Ended March 31,

Research and development

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

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

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

Net loss per share, basic and diluted

* Reflects the weighted average effect of the pre-funded warrants on the calculation of basic and diluted net loss per share.

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:

Nine Months Ended September 30,

Unvested restricted stock awards

Unvested performance-based restricted stock unit awards

Three Months Ended March 31,

Options to purchase common stock

Unvested performance-based restricted stock unit awards

Unvested restricted stock awards

Employee stock purchase plan contingently issuable

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The Dropbox Sublease Agreement is for a period of two years commencing on September 5, 2023 and ending December 31, 2025.

According to the terms of the Dropbox Sublease Agreement, the

Company paid a $ 0.1 million security deposit and is required to pay monthly rent and common area charges.

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

The sublease was accounted for under Topic 842 and the Company recorded ROU asset and lease liability of $ 0.2 million and $ 0.2 million, respectively, in the accompanying condensed consolidated financial statements.

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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 and nine months ended September 30, 2024 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

The following table summarizes total lease expense during the three months ended March 31, 2025 and 2024 (in thousands):

Three Months Ended March 31,

Straight-line operating lease expense

Short-term lease expense

Variable lease expense

Total operating lease expense

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

Three Months Ended September 30,

Nine Months Ended September 30,

The following table summarizes supplemental cash flow information during the three months ended March 31, 2025 and 2024 (in thousands):

Three Months Ended March 31,

Cash paid for amounts included measurement of lease liabilities:

Operating cash flows from operating leases

Supplemental noncash information on lease liabilities arising from obtaining right-use-assets

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

Years Ending December 31,

2024 (from October 2024)

The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of March 31, 2025 (in thousands):

2025 (from April 2025)

Total future minimum lease payments

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Lease liabilities, non-current

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

September 30,

The following table summarizes lease term and discount rate as of March 31, 2025:

Three Months Ended March 31,

Weighted-average remaining lease term (years)

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Commitments and Contingencies

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 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.

Novartis will manufacture and supply (including primary packaging) the Company with a specified amount of ribociclib, which amount is expected to be sufficient for the OPERA-02 trial.

The parties granted to each other a non-exclusive, royalty-free license under certain of the parties’ respective background patent rights and other technology 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.

Any inventions developed in the performance of the clinical studies for the combined therapies (other than those specific to each component study drug) are jointly owned by the parties.

Except as otherwise specified below, the Novartis Pharma Agreement does not grant any right of first negotiation to participate in future clinical trials, and each party retains all rights and ability to evaluate their respective compounds in any studies or clinical trials, either as a monotherapy or in combination with any other product or compound, in any therapeutic area.

The parties retain their independent rights to commercialize their respective therapies both alone and with third parties.

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.

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 .

If the Company’s board of directors (or a duly authorized board committee) determines that the Company should pursue or explore a change of control of the Company or sale of all or substantially all of its assets (an "Olema Change of Control"), other than in response to an unsolicited bona fide acquisition proposal (a "Proposed Sale"), the Company must promptly notify Novartis of such determination.

In the event Novartis elects to engage in negotiations with the Company in respect of such Proposed Sale, then from the date such notice is given until 45 days after the later of (a) the date on which the foregoing notice is given to Novartis, (b) the date on which Novartis is given notice that a data room has been populated as required by the Novartis Pharma Agreement, and (c) entry by the Company and Novartis into a customary nondisclosure agreement, Novartis will have the exclusive right (but no obligation) to conduct due diligence on the Company and its business and negotiate with the Company and its representatives the definitive terms and conditions of the Proposed Sale.

If the Company or its affiliates receive an unsolicited bona fide acquisition proposal from a third party, the Company must promptly notify its board of directors (or a duly authorized board committee) of the receipt thereof and request that they consider the merits of such acquisition proposal.

If, after such consideration, the Company’s board of directors (or authorized committee) authorizes the Company to engage in negotiations with regard to such acquisition proposal, then the Company must notify Novartis in writing within 24 hours of receipt of such authorization.

To the extent possible in light of any confidentiality obligations, such notice must include a summary of the key structural, non-financial terms of such acquisition proposal.

In the event of an Olema Compound Transaction or Olema Change of Control involving a third party other than Novartis (the first to occur, a "Repayment Trigger Event"), the Company must promptly pay, or procure the payment of, the Repayment Amount (as defined below) to Novartis.

Notwithstanding the foregoing, if the Novartis Pharma Agreement is terminated as a result of certain patient safety issues, lack of product efficacy, regulatory issues or clinical hold issues prior to the consummation of the Olema Compound Transaction or Olema Change of Control, then the Company shall not be obligated to pay the Repayment Amount unless (a) the Olema Change of Control or Olema Compound Transaction occurs after such termination and (b) prior to the fifth anniversary of such Olema Change of Control or Olema Compound Transaction (as applicable), the Company or its affiliates (or the applicable acquirer, successor, licensee or optionholder of the Company or its affiliates) enrolls a subject in any clinical study involving the combination of palazestrant and ribociclib (the "Olema Combination") or submits any filing with any regulatory authority relating to the Olema Combination.

The “Repayment Amount” is the proportion of approximately $ 275 million that is represented by the number of units of ribociclib actually supplied to the Company under the Supply Agreement as of immediately prior to the Repayment Trigger Event as compared to the total number of units that could be supplied under the Novartis Pharma Agreement.

The foregoing rights of first negotiation, first offer and notice and repayment obligations remain in effect until the first to occur of:

(a) the date that is 120 days after filing of the New Drug Application for the Olema Combination, (b) one year after any expiration or termination of the Novartis Pharma Agreement, and (c) such time as the Novartis Pharma Agreement is terminated by the Company due to Novartis’ material breach.

However, in the event the Novartis Pharma Agreement is terminated due to certain patient safety issues, lack of product efficacy, regulatory issues or clinical hold issues prior to the consummation of an Olema Change of Control or Olema Compound Transaction, then the Repayment Obligation shall survive until the fifth anniversary of such Olema Change of Control or Olema Compound Transaction (as applicable) or, if payment of the Repayment Amount is required, until the next business day after the Repayment Amount has been received by Novartis.

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).

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 months ended March 31, 2025.

Loan Agreement

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 September 30, 2024, the Company had not drawn down funds under the Credit Facility.

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

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"), of which $ 25.0 million became available upon the closing of a private placement of our common stock to selected institutional and accredited investors pursuant to a securities purchase agreement in September 2023, and the remaining $ 25.0 million could have been made available upon approval of the Bank in its discretion.

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

On June 28, 2024, the Company entered into a First Amendment to Loan and Security Agreement (the "Amendment"), by and between the Company and the Bank, which amends the terms of the Original Loan Agreement (the Original Loan Agreement, as amended, the "Loan Agreement"), in order to, among other things, (i) increase the aggregate principal amount of the Original Credit Facility from up to $ 50 million to up to $ 100 million, of which $ 25 million is currently 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 (the Original Credit Facility, as amended, the "Credit Facility"), and (ii) extend the Original Maturity Date to July 1, 2028 .

As of March 31, 2025, the Company had not drawn down from the Credit Facility.

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

24 unchanged sentences

On July 22, 2020, the Company entered into a non-exclusive clinical collaboration and supply agreement with Novartis Institutes for BioMedical Research, Inc.

(“Novartis”).

On January 13, 2022, the Company entered into the amended and restated clinical collaboration and supply agreement with Novartis, and on October 9, 2023, the Company and Novartis entered into the amendment no.

1 (the “Novartis Amendment 1”) to amended and restated clinical collaboration and supply agreement, and on March 22, 2024, the Company and Novartis entered into the amendment no.

2 (the “Novartis Amendment 2”) to amended and restated clinical collaboration and supply agreement (as amended, the “Novartis Agreement”).

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.

On January 13, 2022, the Company entered into an amended

and restated clinical collaboration and supply agreement with Novartis, and on October 9, 2023, the Company and Novartis entered into the amendment no.

1 (the "Novartis Amendment") to the amended and restated clinical collaboration and supply agreement (as amended, the "Novartis Agreement").

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 ("PI3Ka") 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, among other things, expanded the Company's 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.

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

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Costs associated with research activities performed under the agreement are included in research and development expenses in the accompanying condensed consolidated financial statements, with any reimbursable costs from Novartis reflected as a reduction of such expenses.

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

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

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

Clinical Trial Agreement

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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 (other than IBRANCE®).

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

responsible for manufacturing and delivering to us IBRANCE® in such quantities as reasonably needed for the clinical trials for the combined therapies.

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.

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 nine months ended September 30, 2024, and 2023.

License Agreement

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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 and recorded as research and development expense in the accompanying condensed consolidated statements of operations and comprehensive loss.

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

Costs incurred and milestones payments due to Aurigene prior to regulatory approval are recognized as research and development expenses in the period incurred.

1 unchanged sentence

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 September 30, 2024.

There was no milestone met during the three months ended March 31, 2025.

In April 2025, a milestone for $ 10.0 million payment related to dosing of the fifth patient in the first Phase 1 trial was met.

Management Services Agreements

The Company conducts research and development programs internally and through third parties that include, among others, arrangements with vendors, consultants, CMOs, and CROs.

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.

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 September 30, 2024, the Company did not have material contractual commitments with respect to these arrangements.

As of March 31, 2025, the Company did not have material contractual commitments with respect to these arrangements.

Contingencies

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

As of March 31, 2025, the Company had not incurred any material costs as a result of such indemnifications.

Pre-Funded Warrants

The Company accounts for the pre-funded warrants as a freestanding equity-linked financial instrument that met the criteria for equity classification pursuant to ASC 480 and ASC 815.

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 March 31, 2025:

Expiration Date

Exercise Price

Number of Warrants Outstanding

2024 (Private Placement)

2024 (Warrant Exchange Agreement)

2025 (Warrant Exchange Agreement)

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