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Our lead product candidate, palazestrant, is a novel, orally-available small molecule with dual activity as both a CERAN and SERD, currently being investigated in patients with recurrent, locally advanced or metastatic ER+/HER2- breast cancer.
−Removed: In non-clinical models, palazestrant binds and completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer.
+Added: In pre-clinical models, palazestrant binds and completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of ER+ MBC.
In clinical studies across more than 400 patients, palazestrant has demonstrated strong anti-tumor activity, attractive pharmacokinetics and prolonged drug exposure, favorable tolerability, and combinability with CDK4/6 inhibitors with no significant drug-drug interaction.
Based on the clinical results we have achieved to date, we are advancing palazestrant through late-stage clinical development both as a monotherapy and in combination with other targeted agents.
−Removed: In November 2023, we initiated OPERA-01, the pivotal Phase 3 clinical trial of palazestrant as a monotherapy in second/third-line ER+/HER2- metastatic breast cancer.
−Removed: We anticipate top-line results in 2026.
−Removed: In combination, we are investigating palazestrant in multiple Phase 1/2 studies with CDK4/6 inhibitors (palbociclib or ribociclib), a PI3Ka inhibitor (alpelisib), and with an mTOR inhibitor (everolimus).
−Removed: In March 2024, we increased the size of the ongoing Phase 1/2 clinical study of palazestrant in combination with ribociclib by an additional 15 patients to explore 90 mg of palazestrant in combination with 600 mg of ribociclib.
−Removed: We also initiated our Phase 1b/2 clinical study of palazestrant in combination with an mTOR inhibitor, everolimus, in the third quarter of 2024.
−Removed: Further, in October 2024, we presented new non-clinical data at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics showing that the combination of palazestrant with both everolimus and capivasertib may be synergistic and have the potential to result in significant tumor regression.
−Removed: More recently, we presented updated results from the ongoing Phase 1b/2 clinical trial of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or metastatic breast cancer at SABCS in December 2024.
−Removed: In March 2025, we disclosed updated median PFS (mPFS) from this study at the TD Cowen 45th Annual Health Care Conference.
−Removed: As of a data cutoff date of February 18, 2025, the mPFS was 13.8 months in 56 patients treated with 120 mg of palazestrant and 600 mg of ribociclib daily.
−Removed: 40 of the 56 patients had received prior treatment of a CDK4/6i plus an ET;
−Removed: the mPFS in this population was 13.1 months.These data further support our thesis that palazestrant possesses key characteristics to make it a potential backbone endocrine therapy of preference for ER+/HER2- breast cancer, while also providing the basis for a new pivotal Phase 3 clinical trial of palazestrant in combination with ribociclib in front-line ER+/HER2- metastatic breast cancer, called OPERA-02.
−Removed: The execution of OPERA-02 will be supported by our new clinical trial collaboration and supply agreement with Novartis, which was announced in December 2024.
−Removed: Under the terms of the
−Removed: agreement, Novartis will provide Olema with ribociclib drug supply for OPERA-02, which we expect to initiate in 2025.
+Added: In November 2023, we initiated OPERA-01, our pivotal Phase 3 clinical trial of palazestrant as a monotherapy in second/third-line ER+/HER2- metastatic breast cancer.
+Added: We anticipate top-line results for this trial in the fall of 2026, expect to submit the NDA in 2027, and, if successful, anticipate potential FDA approval and commercial launch in late 2027.
+Added: In combination, we are investigating palazestrant in multiple Phase 1/2 studies with CDK4/6 inhibitors (palbociclib or ribociclib), a phosphatidylinositol-3-kinase alpha inhibitor (alpelisib), an mTOR inhibitor (everolimus), and a CDK4 inhibitor (atirmociclib).
+Added: In October 2025, at ESMO, we presented updated results from the ongoing Phase 1b/2 clinical trial of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or metastatic breast cancer.
+Added: This data further support our thesis that palazestrant possesses key characteristics to make it a potential backbone endocrine therapy of preference for ER+/HER2- breast cancer, while also supporting the ongoing pivotal Phase 3 clinical trial of palazestrant in combination with ribociclib in front-line ER+/HER2- metastatic breast cancer, called OPERA-02.
+Added: The execution of OPERA-02 is supported by our clinical trial collaboration and supply agreement with Novartis Pharma AG (Novartis), which was also announced in December 2024.
+Added: Under the terms of the agreement, Novartis is providing Olema with ribociclib drug supply for the OPERA-02 trial, which we initiated in 2025.
+Added: We anticipate top-line data in 2028 and, if successful, anticipate potential FDA approval and commercial launch in the frontline MBC setting in the United States in 2029.
Our second product candidate in clinical development, called OP-3136, is a novel, orally-available small molecule that potently and selectively inhibits KAT6, an epigenetic target that is dysregulated in breast and other cancers.
−Removed: We believe OP-3136 presents a potential best-in-class KAT6 inhibitor in breast and other solid tumor cancers.
−Removed: In October 2024, we presented new non-clinical data at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics demonstrating OP-3136's robust anti-tumor activity as a single agent, as well as potential synergy and enhanced anti-tumor activity in combination with palazestrant.
−Removed: The IND application for OP-3136 was cleared by the U.S FDA in late 2024 and the Phase 1 clinical trial is now enrolling patients.
+Added: The IND application for OP-3136 was cleared by the FDA in late 2024, and the Phase 1 study is enrolling patients, and we expect to present the first clinical data from this program in the second quarter of 2026.
Since our inception, we have devoted substantially all of our resources to organizing and staffing our company, research and development activities, business planning, raising capital, establishing and maintaining our intellectual property portfolio, conducting non-clinical studies and clinical trials and providing general and administrative support for these operations.
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We expect our expenses and capital requirements will increase significantly in connection with our ongoing activities as we:
−Removed: • continue our ongoing and planned research and development of our lead product candidate, palazestrant, for the treatment of ER+/HER2- metastatic breast cancer;
−Removed: • enroll patients in the Phase 1 clinical trial for OP-3136 and any additional product candidates that we may pursue in the future;
+Added: • continue our ongoing and planned research and development of our lead product candidate, palazestrant, for the treatment of ER+/HER2- breast cancer;
+Added: • continue to enroll patients in the Phase 1 study for OP-3136 and any additional product candidates that we may pursue in the future;
• seek to discover and develop additional product candidates and further expand our clinical product pipeline;
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• add clinical, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts;
−Removed: • expand our operations in the United States and to other geographies;
+Added: • expand our operations in the United States and in other geographies;
• incur additional legal, accounting, investor relations and other expenses associated with operating as a public company.
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We may be unable to raise additional funds or to enter into such agreements or arrangements on favorable terms, or at all.
−Removed: Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and volatility in, the credit and financial markets in the United States and worldwide resulting from geopolitical and macroeconomic conditions.
+Added: Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions, geopolitical uncertainty and volatility in, the credit and financial markets in the United States and worldwide resulting from geopolitical and macroeconomic conditions.
Our failure to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to have to delay, reduce, or eliminate our product development or future commercialization efforts.
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The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our development efforts.
−Removed: We cannot provide assurance that we will ever be profitable or generate positive cash flow from operating activities.
−Removed: Global economic and business activities continue to face widespread uncertainty due to the geopolitical and macroeconomic environment, generally, including economic uncertainty, market volatility, labor shortages, tariffs and trade tensions, 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, inflation rates and the responses by central banking authorities to control such inflation, monetary supply shifts, and related financial instability.
+Added: We cannot provide assurance that we will ever be profitable or generate revenue or positive cash flow from operating activities.
+Added: Global economic and business activities continue to face widespread uncertainty due to the geopolitical and macroeconomic environment, generally, including economic and geopolitical uncertainty, market volatility, labor shortages, evolving trade and tariffs policies, including related legal challenges, trade tensions, and retaliatory measures by other countries, supply chain disruptions, military conflicts, as well as any related political or economic responses or counter-responses 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 our operational and financial performance, including our ability to execute our business strategies and initiatives in the expected time frame, will depend on future developments, which are uncertain and cannot be predicted.
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External expenses include:
−Removed: • expenses incurred in connection with the discovery and non-clinical development of our product candidates, including under agreements with third parties, such as consultants and contract research organizations (CROs);
−Removed: • costs of manufacturing products for use in our non-clinical studies and clinical trials, including payments to contract manufacturing organizations (CMOs), and consultants;
+Added: • expenses incurred in connection with the discovery efforts and non-clinical and clinical development of our product candidates, including under agreements with third parties, such as consultants and CROs;
+Added: • costs of manufacturing products for use in our non-clinical studies and clinical trials, including payments to CMOs, and consultants;
• costs of funding research performed by third parties;
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• expenses related to regulatory activities, including filing fees paid to regulatory agencies;
−Removed: • facility costs including rent, depreciation and maintenance expenses.
+Added: • allocated facility-related costs, which include rent, depreciation and maintenance expenses, and other operating costs.
Internal expenses include employee and personnel-related costs and expenses, including salaries, benefits and stock-based compensation expense for employees and personnel engaged in research and development functions.
We expense research and development expenses in the periods in which they are incurred.
−Removed: Costs for certain activities, such as manufacturing and non-clinical studies and clinical trials, are generally recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and collaborators.
+Added: Costs for certain activities, such as manufacturing, non-clinical studies, and clinical trials, are generally recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and collaborators.
We typically use our employee, consultant, and infrastructure resources across our development programs.
We track outsourced development costs by product candidate or non-clinical program, but we do not allocate personnel costs, other internal costs, or external consultant costs to specific product candidates or non-clinical programs.
−Removed: While our research and development expenses may fluctuate from period to period, we generally expect our research and development expenses to increase substantially in absolute dollars for the foreseeable future as we advance palazestrant, OP-3136 or any other future product candidates we may develop into and through non-clinical studies and clinical trials and pursue regulatory approval of our product candidates.
+Added: While our research and development expenses may fluctuate from period to period, we generally expect our research and development expenses to increase substantially in absolute dollars for the foreseeable future as we advance palazestrant, OP-3136, or any future product candidates we may develop into and through non-clinical studies and clinical trials and pursue regulatory approval of our product candidates.
The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming.
−Removed: The actual probability of success for palazestrant, OP-3136 or any other future product candidates we may develop may be affected by a variety of factors including but not limited to:
+Added: The actual probability of success for palazestrant, OP-3136, or any future product candidates we may develop may be affected by a variety of factors including but not limited to:
the safety and efficacy of our product candidates, early clinical data, investment in our clinical program, the ability of collaborators to successfully develop our licensed product candidates, competition, manufacturing capability, and commercial viability.
We may never succeed in achieving regulatory approval for our product candidates.
−Removed: As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of palazestrant, OP-3136 or any other future product candidates we may develop.
−Removed: Clinical and non-clinical
−Removed: development timelines, the probability of success and development costs can differ materially from expectations.
+Added: As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of palazestrant, OP-3136, or any future product candidates we may develop.
+Added: Clinical and non-clinical development timelines, the probability of success and development costs can differ materially from expectations.
We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future non-clinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate’s commercial potential.
−Removed: In addition, we cannot forecast whether palazestrant, OP-3136 or any other future product candidates we may develop may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
+Added: In addition, we cannot forecast whether palazestrant, OP-3136, or any future product candidates we may develop may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
We are also unable to predict when, if ever, we will generate revenue from our product candidates to offset these expenses.
Our expenditures on current and future non-clinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion.
−Removed: The duration, costs and timing of non-clinical studies and clinical trials and development of our product candidates will depend on a variety of factors, including:
+Added: The duration, costs, and timing of non-clinical studies, clinical trials, and development of our product candidates will depend on a variety of factors, including:
• the timing and progress of non-clinical and clinical development activities;
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General and administrative
−Removed: General and administrative expenses consist primarily of personnel expenses, including salaries, benefits and stock-based compensation expense, for personnel in executive, finance, accounting, business development, legal, human resources, information technology (IT), and administrative functions.
−Removed: General and administrative expenses also include costs not otherwise included in research and development expenses, including corporate facility costs, depreciation and other expenses, which include direct or allocated expenses for rent and maintenance of facilities and insurance, and professional fees for legal, patent and consulting services.
−Removed: While our general and administrative expenses may fluctuate from period to period, we generally expect that our general and administrative expenses will increase in the foreseeable future as we increase our headcount to support the continued research and development of our programs and the growth of our business.
−Removed: We also anticipate incurring additional expenses associated with operating as a public company, including increased expenses related to the building and improving of our IT infrastructure, including cyber security monitoring, legal, other regulatory and compliance, director and officer insurance, investor and public relations and tax-related services associated with maintaining compliance with the rules and regulations of the SEC and standards applicable to companies listed on a national securities exchange, additional insurance expenses, investor relations activities and other administrative and professional services.
+Added: General and administrative expenses consist primarily of personnel expenses, including salaries, benefits, and stock-based compensation expense, for personnel in executive, finance, accounting, business development, communications, and investor relations, commercialization, legal, human resources, information technology (IT), and administrative functions.
+Added: General and administrative expenses also include costs not otherwise included in research and development expenses, including corporate facility costs, depreciation, and other expenses, which include rent and maintenance of facilities and insurance, and professional fees for legal, patent and consulting services.
+Added: While our general and administrative expenses may fluctuate from period to period, we generally expect that our general and administrative expenses will increase in the foreseeable future as we increase our headcount to support the continued research and development of our programs, the potential future commercialization of our product candidates, and the growth of our business.
+Added: We also anticipate incurring additional expenses associated with operating as a public company, including increased expenses related to the building and improving of our IT infrastructure, such as cybersecurity monitoring, legal, regulatory and compliance, director and officer insurance, investor and public relations, and tax-related services associated with maintaining compliance with the rules and regulations of the SEC and the standards applicable to companies listed on a national securities exchange, as well as additional insurance expenses and other administrative and professional services.
Total other income
Total other income consists of interest income and other income.
−Removed: Interest income primarily consists of interest income on our cash equivalents and marketable securities.
−Removed: Other income primarily consists of unrealized foreign currency remeasurement gain (loss) and miscellaneous income (expense) not related to operating activities.
+Added: Interest income primarily consists of interest earned from our cash equivalents and marketable securities.
+Added: Other income primarily consists of realized and
+Added: unrealized foreign currency remeasurement gain (loss), interest expense, and other miscellaneous income (expense) not related to operating activities.
Results of operations
1 unchanged sentence
The following table summarizes our results of operations for the years ended December 31, 2025 and 2024:
−Removed: Year Ended December 31,
+Added: Years Ended December 31,
(in thousands)
4 unchanged sentences
Loss from operations
−Removed: Other income (expense):
+Added: Other income:
Interest income
−Removed: Other income (expense)
Total other income
+Added: ¹The amounts for the years ended December 31, 2025 and 2024 include one-time milestone payments to Aurigene of $10.0 million and $5.0 million, respectively, pursuant to the Aurigene Agreement.
+Added: For more information about the Aurigene Agreement, see the section titled “Business—License Agreement with Aurigene."
Research and development expenses
The following table summarizes our research and development expenses by functional area for the years ended December 31, 2025 and 2024:
−Removed: Year Ended December 31,
+Added: Years Ended December 31,
(in thousands)
1 unchanged sentence
Compensation and related benefits
−Removed: Stock-based compensation
Other research and development expenses
+Added: Stock-based compensation
+Added: Milestone payment made to Aurigene
Total research and development expenses
Research and development expenses for the year ended December 31, 2025 were $157.7 million, compared to $124.5 million for the year ended December 31, 2024.
−Removed: The increase of $38.4 million was primarily due to (i) increased spending on clinical operations and development-related activities as we continue to advance palazestrant through late-stage clinical trials, (ii) other research and development activities associated with the advancement of our KAT6 inhibitor program, and (iii) personnel-related costs related to increased headcount, including an increase in non-cash stock-based compensation expense of $4.8 million.
+Added: The increase of $33.2 million was primarily related to (i) increased spending on clinical operations and development-related activities as we continue to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, (ii) an increase of $5.0 million in the milestone payment to Aurigene, and (iii) increased personnel-related costs due to higher headcount, partially offset by a decrease in non-cash stock-based compensation expense of $4.4 million mainly due to the lower grant-date fair value of stock options granted during the first three quarters of 2025.
General and administrative expenses
General and administrative expenses for the year ended December 31, 2025 were $21.0 million compared to $17.7 million for the year ended December 31, 2024.
−Removed: The decrease of $1.1 million was primarily due to decreased spending on corporate-related costs, partially offset by an increase in non-cash stock-based compensation expense of $0.6 million related to increased headcount.
+Added: The increase of $3.3 million was primarily related to higher corporate-related costs and personnel-related costs, partially offset by a decrease in non-cash stock-based compensation expense of $0.6 million due to the lower grant-date fair value of stock options granted during the first three quarters of 2025.
Other income for the year ended December 31, 2025 was $16.2 million, compared to $12.8 million for the year ended December 31, 2024.
4 unchanged sentences
Our net losses were $162.5 million and $129.5 million for the years ended December 31, 2025 and 2024, respectively.
−Removed: Through December 31, 2024, we had received aggregate gross proceeds of $789.0 million from sales of our common stock, convertible preferred stock and issuance of convertible promissory notes, stock option exercises, and sale of stock through the Company’s 2020 Employee Stock Purchase Plan (ESPP).
+Added: From our inception through December 31, 2025, we had received aggregate net proceeds of $1.0 billion from sales of our common stock, convertible preferred stock and issuance of convertible promissory notes, stock option exercises, sale of stock through the Company’s 2020 Employee Stock Purchase Plan (ESPP), and borrowings under our Credit Facility, as defined below.
As of December 31, 2025, we had $505.4 million in cash, cash equivalents and marketable securities and accumulated deficit of $597.6 million.
−Removed: We had no debt outstanding as of December 31, 2024.
−Removed: On September 5, 2023, we entered into a stock purchase agreement for a private placement of 13,211,381 shares of our common stock, at a price of $9.84 per share, to selected institutional and accredited investors (the 2023 Private Placement), resulting in gross proceeds of approximately $130.0 million.
+Added: On September 5, 2023, we entered into the Original Loan Agreement with the Bank, which provided us with the Original Credit Facility, of which $25.0 million became available in September 2023 as Term Loan A upon the closing of a private placement and issuance of our common stock to selected institutional and accredited investors pursuant to a securities purchase agreement, and the remaining $25.0 million could have been made available upon approval of the Bank in its discretion.
+Added: The Original Credit Facility was to mature on August 1, 2027.
+Added: On June 28, 2024, we entered into the First Amendment with the Bank, which, among other things, (i) increased the aggregate principal amount of the Original Credit Facility from up to $50.0 million to up to $100.0 million of which the Term Loan A of $25.0 million was immediately available, an additional $25.0 million will become available upon achieving certain milestones related to the execution of a first-line pivotal Phase 3 clinical trial of palazestrant in combination with ribociclib as Term Loan B, and an additional $50.0 million which may be made available upon approval of the Bank in its discretion as Term Loan C, and (ii) extended the maturity date to July 1, 2028.
+Added: On June 27, 2025, we entered into the Second Amendment with the Bank, which, among other things, (i) decreased the interest rate to a floating rate equal to the greater of 6.0% or the prime rate, and (ii) extended the draw period of Term Loan A to January 15, 2026.
+Added: As of December 31, 2025, we had an outstanding liability of $3.0 million under the Credit Facility, representing the full amount drawn to date.
+Added: On January 11, 2026, we entered into the Third Amendment, which, among other things, (i) extended the draw period of Term Loan A to January 31, 2027, (ii) extended the draw period of Term Loan B to January 31, 2027, (iii) extended the draw period of Term Loan C to January 31, 2027, and (iv) extended the Maturity Date to January 1, 2029.
+Added: Based on the occurrence of specified (a) development milestones related to the pivotal Phase 3 OPERA-01 clinical trial of palazestrant or (b) receipt of proceeds from capital financing, the draw period of Term Loan B and Term Loan C may be further extended to July 31, 2027, and the Maturity Date (as so extended) may be further extended to July 1, 2029.
+Added: On November 29, 2024, we 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).
+Added: 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.
−Removed: Also on September 5, 2023, we entered into a loan and security agreement (the Original Loan Agreement) with Silicon Valley Bank, a division of First Citizens Bank & Trust Company (the Bank), which provided us with an aggregate principal amount of up to $50.0 million (the Original Credit Facility).
−Removed: On June 28, 2024, we entered into the First Amendment to Loan and Security Agreement (the Amendment, and the Original Loan Agreement as amended by the Amendment, the Loan Agreement), with the Bank.
−Removed: The Amendment 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 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.
−Removed: As of December 31, 2024, we had not drawn down from the Credit Facility.
−Removed: On November 29, 2024, we 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,
−Removed: 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).
−Removed: The aggregate gross proceeds for the 2024 Private Placement was approximately $250.0 million.
−Removed: After deducting offering expenses related to the 2024 Private Placement of approximately $6.5 million (the remaining $6.5 million was included in Other current liabilities in the consolidated balance sheets), the net proceeds to us from the 2024 Private Placement were approximately $243.5 million.
−Removed: On January 5, 2024, we entered into a sales agreement (the 2024 Sales Agreement), with Cowen and Company, LLC (TD Cowen), as sales agent, pursuant to which we 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 2024 ATM Shares).
−Removed: The sales, if any, of the ATM Shares will be made by any method permitted that is deemed to be an “at-the-market” (ATM), 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.
−Removed: We have 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.
+Added: Of the $13.0 million issuance costs, $6.5 million was paid in the fourth quarter of 2024 and $6.5 million was paid in the first quarter of 2025.
+Added: Concurrently, on November 29, 2024, we entered in an exchange agreement with an investor and issued to such investor pre-funded warrants to purchase up to 3,420,000 shares of our common stock at an exercise price of $0.0001 per share, in exchange for 3,420,000 shares of our common stock previously outstanding and held by such investor.
+Added: Thereafter, on January 10, 2025, we entered into exchange agreements with certain investors pursuant to which we issued pre-funded warrants to purchase up to 6,070,000 shares of our common stock at an exercise price of $0.0001 per share, in exchange for 6,070,000 shares of our common stock previously outstanding and held by such investors (Exchange Transactions).
+Added: Certain holders of pre-funded warrants (together with such holder’s affiliates and other attribution parties) may not exercise pre-funded warrants held by them to the extent that immediately prior to or after giving effect to such exercise such holder would own more than 9.99% of our outstanding common stock immediately after exercise, which percentage may be changed at the holder’s election to a lower or higher percentage not in excess of 19.99% upon 61 days’ notice to us, subject to the terms of the pre-funded warrants.
+Added: Refer to Note 7 of our notes to the consolidated financial statements contained in this Annual Report for further information regarding the Exchange Transactions.
+Added: On January 5, 2024, we entered into a sales agreement (the 2024 Sales Agreement), with Cowen and Company, LLC (Cowen and Company), as sales agent, pursuant to which we were permitted to offer and sell, from time to time, shares of our common stock, having an aggregate offering price of up to $150.0 million (the 2024 ATM Shares).
+Added: The sales of the 2024 ATM Shares were made as an “at-the-market” (ATM) equity offering as defined in Rule 415(a)(4) promulgated under the Securities Act.
+Added: We agreed to pay Cowen and Company a commission of up to 3.0% of the aggregate gross proceeds from any 2024 ATM Shares sold by Cowen and Company.
During the year ended December 31, 2024, we issued 1,772,278 shares of our 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.
−Removed: As of December 31, 2024, approximately $126.6 million remained available for issuance under the Sales Agreement.
−Removed: On January 6, 2025, we entered into a sales agreement (the 2025 Sales Agreement) with TD Securities (USA) LLC, (TD Cowen) as sales agent, pursuant to which the Company may offer and sell, from time to time, shares of the Company's common stock, having an aggregate offering price of up to $150.0 million (the 2025 ATM Shares).
−Removed: The 2025 Sales Agreement replaces our prior 2024 Sales Agreement, dated January 5, 2024.
−Removed: 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 of 1933, as amended, including sales made directly on or through the Nasdaq Global Select Market.
−Removed: We have 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.
+Added: On January 6, 2025, we entered into a sales agreement (the 2025 Sales Agreement) with TD Securities (USA) LLC, (TD Cowen) as sales agent, pursuant to which the Company could 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).
+Added: The 2025 Sales Agreement replaced our 2024 Sales Agreement, and no further sales could be made pursuant to the 2024 Sales Agreement.
+Added: The sales of the 2025 ATM Shares would be made by any method permitted that is deemed to be an ATM 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.
+Added: We 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.
+Added: On December 11, 2025, we entered into Amendment No.
+Added: 1 to the 2025 Sales Agreement, which increased the maximum aggregate offering price under the ATM program to $200.0 million.
+Added: As of December 31, 2025, no securities had been sold under the 2025 Sales Agreement.
+Added: On November 19, 2025, we completed a follow-on public offering pursuant to which we sold 11,500,000 shares of common stock at a public offering price of $19.00 per share, including 1,500,000 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares, resulting in aggregate net proceeds of $204.8 million, after deducting underwriting discounts and commissions and estimated offering costs.
+Added: Sales of our common stock were made under our shelf registration on Form S-3, which we initially filed with the SEC on January 6, 2025 and that was declared effective by the SEC on January 15, 2025.
We expect to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of palazestrant, OP-3136, and non-clinical studies.
−Removed: We expect that our research and development and general and administrative costs will increase in connection with conducting additional non-clinical studies and clinical trials for our current and future research programs and product candidates, contracting with CMOs to support non-clinical studies and clinical trials, expanding our intellectual property portfolio, and providing general and administrative support for our operations.
+Added: We expect that our research and development and general and administrative costs will increase in connection with conducting additional non-clinical studies and clinical trials for our current and future research programs and product candidates, contracting with CMOs to support non-clinical studies and clinical trials, expanding our intellectual property portfolio, developing our commercialization capabilities, and providing general and administrative support for our operations.
As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements or other sources.
6 unchanged sentences
In addition, if we obtain marketing approval for our product candidates, we expect to incur significant commercialization expenses related to program sales, marketing, manufacturing, and distribution to the extent that such sales, marketing, and distribution are not the responsibility of potential collaborators.
−Removed: Furthermore, we have incurred and expect to continue to incur additional costs associated with
−Removed: operating as a public company.
+Added: Furthermore, we have incurred and expect to continue to incur additional costs associated with operating as a public company.
The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our development efforts.
−Removed: We expect our cash, cash equivalents, and marketable securities as of December 31, 2024, as well as the available balance under the Credit Facility, will enable us to fund our current operating plan for at least the next 12 months from the filing date of these consolidated financial statements.
+Added: We expect our cash, cash equivalents, and marketable securities as of December 31, 2025, as well as the available balance under the Credit Facility, will enable us to fund our current operating plan through mid-2028.
+Added: We have based this estimate of cash runway on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.
The following table presents our material cash requirements for future periods:
1 unchanged sentence
(in thousands)
+Added: Credit Facility
Operating leases
−Removed: (1) We conduct our research and development programs internally and through third parties that include, among others, arrangements with vendors, consultants, CMOs, and CROs.
−Removed: We have contractual arrangements in the normal course of business with these parties, however, our contracts with them are cancelable generally on reasonable notice within one year and our obligations under these contracts are primarily based on services performed.
−Removed: We included certain contracts that have significant cancellation penalties and are material, which make the continuation of these arrangements reasonable.
In addition, under the Aurigene Agreement, we have payment obligations that are contingent upon future events such as the achievement of specified development, regulatory and commercial milestones.
−Removed: Financial terms of the Aurigene Agreement include potential future milestone payments of up to $55.0 million in clinical development and regulatory milestones, and up to $370.0 million in commercial milestones.
+Added: Financial terms of the Aurigene Agreement include remaining potential future milestone payments of up to $45.0 million in clinical development and regulatory milestones, and up to $370.0 million in commercial milestones.
Aurigene is also eligible to receive mid-single digit to the low double digit royalties as percentages of product sales, if any.
24 unchanged sentences
Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
+Added: For example, our Loan Agreement includes covenants limiting our ability to, among other things, fund future acquisitions, make dividend payments, or obtain additional financing.
If we raise funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates or to grant licenses on terms that may not be favorable to us.
1 unchanged sentence
The following table shows a summary of our cash flows for each of the periods presented:
−Removed: Year Ended December 31,
+Added: Years Ended December 31,
(in thousands)
2 unchanged sentences
Net cash provided by financing activities
−Removed: Net increase in cash and cash equivalents
+Added: Net (decrease) increase in cash and cash equivalents
Operating activities
2 unchanged sentences
The non-cash charges consisted primarily of stock-based compensation expense of $17.6 million, depreciation and amortization expenses of $0.5 million, and non-cash lease expense of less than $0.1 million, net of cash payments of $1.2 million.
+Added: The net increase in operating assets and liabilities was primarily due to (i) an increase of $11.0 million in other current liabilities, which is primarily
+Added: related to increased spending on clinical development-related activities as we advanced palazestrant through late-stage clinical trials, including initiation activities for OPERA-02, and the OP-3136 program, and (ii) an increase of $4.6 million in accounts payable, which is primarily related to timing of invoicing by vendors and related payments.
+Added: These increases were partially offset by (i) an increase of $6.1 million in other assets and long-term deposits due to project deposits paid to CROs as we advance the OP-3136 program and conduct initiation activities for OPERA-02, and (ii) an increase in prepaid expenses and other current assets of $5.4 million.
+Added: Net cash used in operating activities during the year ended December 31, 2024 consisted primarily of our net loss of $129.5 million and non-cash interest income on our marketable securities of $8.2 million, offset by non-cash charges of $23.0 million and net increase in operating assets and liabilities of $10.3 million.
+Added: The net loss consisted primarily of $124.5 million in research and development expenses and $17.7 million in general and administrative expenses.
+Added: The non-cash charges consisted primarily of stock-based compensation expense of $22.6 million, depreciation and amortization expenses of $0.4 million, and non-cash lease expense of less than $0.1 million, net of cash payments of $1.2 million.
The net increase in operating assets and liabilities was primarily due to (i) an increase of $11.2 million in accrued and other current liabilities and (ii) an increase of $2.5 million in accounts payable, which is primarily resulted from timing of invoicing by vendors and related payments.
The changes are mainly offset by (i) an increase of $3.0 million in other assets and long-term deposits and (ii) an increase of $0.4 million in prepaid expenses and other current assets.
−Removed: Net cash used in operating activities during the year ended December 31, 2023 consisted primarily of our net loss of $96.7 million and non-cash interest income on our marketable securities of $5.5 million, offset by net non-cash charges of $17.8 million and a net increase of $0.6 million in operating assets and liabilities.
−Removed: The net loss consisted primarily of $86.1 million in research and development expenses and $18.8 million in general and administrative expenses.
−Removed: The non-cash charges consisted primarily of stock-based compensation of $17.3 million, depreciation and amortization expenses of $0.4 million, loss on disposal of equipment of $0.1 million, and non-cash lease expense of less than $0.1 million, net of cash payments of $1.2 million.
−Removed: The change in operating assets and liabilities was primarily due to (i) an increase of $2.9 million in other current liabilities, (ii) an increase of $2.3 million in accounts payable, whic primarily resulted from timing of invoicing by vendors and related payments, and (iii) a decrease of $0.7 million in prepaid expenses and other current assets.
−Removed: The changes are mainly offset by an increase of $5.3 million in other assets and long-term deposits.
Investing activities
Net cash used in investing activities during the year ended December 31, 2025 was predominantly due to purchases of marketable securities which were partially offset by maturities of marketable securities.
−Removed: Net cash used in investing activities during the year ended December 31, 2023 was predominately due to the purchase of marketable securities which was partially offset by the maturities of marketable securities.
+Added: Net cash used in investing activities during the year ended December 31, 2024 was predominantly due to purchases of marketable securities which were partially offset by maturities of marketable securities.
Financing activities
+Added: Net cash provided by financing activities during the year ended December 31, 2025 was predominantly due to the $205.4 million in net proceeds from our follow-on public offering in November 2025, $8.4 million from the exercise of stock options, $3.0 million draw down under our Credit Facility and $1.0 million from the sale of our common stock under the ESPP, partially offset by $6.5 million payment of issuance costs previously accrued in connection with the 2024 Private Placement.
Net cash provided by financing activities during the year ended December 31, 2024 consists of $243.5 million in net proceeds from the 2024 Private Placement, $22.8 million in net proceeds from the sale of ATM Shares, $1.7 million from the exercise of stock options, and $0.9 million from the sale of our common stock under the ESPP.
−Removed: Net cash provided by financing activities during the year ended December 31, 2023 consists of $129.7 million in net proceeds from the 2023 Private Placement, $2.7 million from the exercise of stock options, and $1.1 million from the sale of our common stock under the 2020 ESPP.
Critical accounting estimates
9 unchanged sentences
This process involves reviewing purchase orders and open contracts, communicating with our personnel and service providers to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the services when we have not yet been invoiced or otherwise notified of the actual cost.
−Removed: The majority of our service
−Removed: providers invoice us monthly in arrears for services performed or when contractual milestones are met;
+Added: The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met;
however, some require advance payments.
16 unchanged sentences
See Note 2 to our consolidated financial statements contained in this Annual Report for a description of recent accounting pronouncements applicable to our consolidated financial statements.
+Added: Quantitative and Qu alitative Disclosures About Market Risk.
+Added: Interest rate risk
+Added: We are exposed to market risks in the ordinary course of our business.
+Added: These risks primarily include interest rate sensitivities.
+Added: As of December 31, 2025 and 2024, we had cash, cash equivalents and marketable securities of $505.4 million and $434.1 million, respectively.
+Added: We generally hold our cash in interest-bearing bank accounts and money market funds.
+Added: Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S.
+Added: interest rates.
+Added: An immediate 100 basis point change in interest rates as of December 31, 2025 would not have a material effect on the fair market value of our cash, cash equivalents and marketable securities.
+Added: As of December 31, 2025, we had an outstanding long-term borrowing under our Credit Facility of $3.0 million which bears interest at a rate per annum equal to the greater of (i) 6.0% and (ii) the prime rate.
+Added: An immediate 100 basis point change in the prime rate as of December 31, 2025 would not have a material effect on the fair market value of our long-term borrowing.
+Added: Financial institution risk
+Added: We deposit cash and cash equivalents with financial institutions we believe to be of high credit quality to minimize risk with respect to any amounts in excess of insurance limitations.
+Added: Cash amounts held at these financial institutions are insured by the Federal Deposit Insurance Corporation up to $250,000.
+Added: Foreign currency exchange risk
+Added: Our expenses are generally denominated in U.S.
+Added: To date, we have not had any significant foreign currency transactions, and we do not have a formal hedging program with respect to foreign currency.
+Added: A 10.0% increase or decrease in current exchange rates would not have a material effect on our financial results.
+Added: Effects of inflation
+Added: Inflation generally affects us by increasing our cost of labor and research and development costs.
+Added: We do not believe that inflation has had a material effect on our results of operations during the periods presented.
+Added: Consolidated Financial Statements and Supplementary Data.
+Added: Olema Pharmaceuticals, Inc.
+Added: Index to consolidated financial statements
+Added: Report of Independent Registered Public Accounting Firm ( Ernst & Young LLP , New Jersey , PCAOB ID No.
+Added: Consolidated Balance Sheets
+Added: Consolidated Statements of Operations and Comprehensive Loss
+Added: Consolidated Statements of Stockholders’ Equity
+Added: Consolidated Statements of Cash Flows
+Added: Notes to Consolidated Financial Statements
+Added: Report of Independent Registered Public Accounting Firm
+Added: To the Stockholders and the Board of Directors of Olema Pharmaceuticals, Inc.
+Added: Opinion on the Financial Statements
+Added: We have audited the accompanying consolidated balance sheets of Olema Pharmaceuticals, Inc.
+Added: (the Company) as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, stockholders' equity, and cash flows for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with U.S.
+Added: generally accepted accounting principles.
+Added: Basis for Opinion
+Added: These financial statements are the responsibility of the Company's management.
+Added: Our responsibility is to express an opinion on the Company’s financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audits in accordance with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
+Added: As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting.
+Added: Accordingly, we express no such opinion.
+Added: Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
+Added: We believe that our audits provide a reasonable basis for our opinion.
+Added: Critical Audit Matters
+Added: The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that:
+Added: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective or complex judgments.
+Added: The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the account or disclosure to which it relates.
+Added: Clinical Trial Accrual
+Added: Description of the Matter
+Added: As discussed in Note 2 in the consolidated financial statements, the Company enters into contracts with contract research organizations (CROs) to conduct clinical services on their behalf.
+Added: Judgments and estimates are required to determine the amounts accrued for estimated ongoing research and development costs.
+Added: The Company analyzes the progress of the studies or clinical trials, including the phase or
+Added: completion of activities, invoices received and contracted costs.
+Added: Auditing the Company’s accrual for clinical trial costs is complex since the information necessary to estimate the accruals is accumulated from the CROs and the Company's assessment of that information is subject to variability and uncertainty.
+Added: In addition, in certain circumstances, the determination of the nature and amounts of services that have been received during the reporting period requires judgment because the timing and pattern of vendor invoicing does not correspond to the level of services provided, and there may be delays in invoicing from clinical study sites and other vendors.
+Added: How We Addressed the Matter in Our Audit
+Added: To test the clinical trial accrual, our audit procedures included, among others, reading a sample of the Company’s contracts with the CROs to understand key financial and contractual terms and testing the accuracy and completeness of the underlying data used in the accrual computations.
+Added: We also evaluated management’s estimates of the vendor’s progress for a sample of clinical trials by inquiring of the Company’s operations personnel overseeing the clinical trials and obtaining information directly from third party vendors regarding their estimate of costs that have been incurred through December 31, 2025.
+Added: We analyzed the data underlying the accrual balance to evaluate the impact of reasonable changes in the data on the recorded amount of the clinical trial accrual.
+Added: To evaluate the completeness of the accruals, we also examined subsequent invoices from the service providers and cash disbursements to the service providers, to the extent such invoices were received, or payments were made prior to the date that the consolidated financial statements were issued.
+Added: /s/ Ernst & Young LLP
+Added: We have served as the Company‘s auditor since 2020.
+Added: Iselin, New Jersey
+Added: March 16, 2026
+Added: Olema Pharmaceuticals, Inc.
+Added: Consolidated Balance Sheets
+Added: (Amounts in thousands, except for share amounts)
+Added: Current assets:
+Added: Cash and cash equivalents
+Added: Marketable securities
+Added: Prepaid expenses and other current assets
+Added: Total current assets
+Added: Operating lease right-of-use assets
+Added: Other assets and long-term deposits
+Added: Liabilities and stockholders’ equity
+Added: Current liabilities:
+Added: Accounts payable
+Added: Operating lease liabilities, current
+Added: Other current liabilities (Note 6)
+Added: Total current liabilities
+Added: Operating lease liabilities, net of current portion
+Added: Long-term borrowing
+Added: Total liabilities
+Added: Commitments and contingencies (Note 12)
+Added: Stockholders’ equity:
+Added: Preferred stock, $ 0.0001 par value;
+Added: 10,000,000 shares authorized as of December 31, 2025 and 2024;
+Added: no shares issued and outstanding as of December 31, 2025 and 2024.
+Added: Common stock, $ 0.0001 par value;
+Added: 490,000,000 shares authorized as of December 31, 2025 and 2024;
+Added: 81,376,449 and 74,312,608 shares issued and outstanding as of December 31, 2025 and 2024, respectively.
+Added: Additional paid-in capital
+Added: Accumulated other comprehensive income
+Added: Accumulated deficit
+Added: Total stockholders’ equity
+Added: Total liabilities and stockholders’ equity
+Added: See accompanying notes to the consolidated financial statements.
+Added: Olema Pharmaceuticals, Inc.
+Added: Consolidated Statements of Operations and Comprehensive Loss
+Added: (Amounts in thousands, except for share and per share amounts)
+Added: Years Ended December 31,
+Added: Operating expenses:
+Added: Research and development¹
+Added: General and administrative
+Added: Total operating expenses
+Added: Loss from operations
+Added: Other income:
+Added: Interest income
+Added: Total other income
+Added: Net loss per share, basic and diluted
+Added: Weighted average shares used to compute net loss per share, basic and diluted²
+Added: ¹ The amounts for the years ended December 31, 2025 and 2024 include milestone payments to Aurigene of $ 10.0 million and $ 5.0 million, respectively.
+Added: ² For the years ended December 31, 2025 and 2024, the weighted average shares used to compute net loss per share, basic and diluted, include the pre-funded warrants.
+Added: Years Ended December 31,
+Added: Other comprehensive income (loss):
+Added: Net unrealized gain (loss) on marketable securities
+Added: Total comprehensive loss
+Added: See accompanying notes to the consolidated financial statements.
+Added: Olema Pharmaceuticals, Inc.
+Added: Consolidated Statements of Stockholders’ Equity
+Added: (Amounts in thousands, except for share amounts)
+Added: Comprehensive
+Added: Stockholders'
+Added: Balances at December 31, 2023
+Added: Issuance of shares and pre-funded warrants under 2024 private placement, net of issuance costs of $ 12,998
+Added: Issuance of shares under at-the-market offering, net of issuance costs of $ 166
+Added: Exchange of common stock shares for pre-funded warrants
+Added: Stock-based compensation expense
+Added: Exercise of stock options
+Added: Issuance of shares under employee stock purchase plan
+Added: Employee stock purchase plan expense
+Added: Vesting of performance-based restricted stock unit awards
+Added: Vesting of restricted stock awards
+Added: Net unrealized loss on marketable securities
+Added: Balances at December 31, 2024
+Added: Issuance of shares upon follow-on public offering, net of issuance costs of $ 13,688
+Added: Exchange of common stock shares for pre-funded warrants
+Added: Stock-based compensation expense, including employee stock purchase plan expense
+Added: Exercise of stock options
+Added: Issuance of shares under employee stock purchase plan
+Added: Net unrealized gain on marketable securities
+Added: Balances at December 31, 2025
+Added: See accompanying notes to the consolidated financial statements.
+Added: Olema Pharmaceuticals, Inc.
+Added: Consolidated Statements of Cash Flows
+Added: (Amounts in thousands)
+Added: Years Ended December 31,
+Added: Cash flows from operating activities:
+Added: Adjustments to reconcile net loss to net cash used in operating activities:
+Added: Depreciation and amortization expense
+Added: Non-cash lease expense
+Added: Non-cash interest income on marketable securities
+Added: Stock-based compensation expense, including employee stock purchase plan expense
+Added: Loss on disposal of equipment
+Added: Changes in operating assets and liabilities:
+Added: Prepaid expenses and other current assets
+Added: Other assets and long-term deposits
+Added: Accounts payable
+Added: Other current liabilities
+Added: Operating lease liabilities
+Added: Net cash used in operating activities
+Added: Cash flows from investing activities:
+Added: Purchase of equipment
+Added: Maturities of marketable securities
+Added: Purchases of marketable securities
+Added: Net cash used in investing activities
+Added: Cash flows from financing activities:
+Added: Proceeds from issuance of shares upon follow-on public offering, net of issuance costs of $ 13,110
+Added: Proceeds from issuance of shares under at-the-market offering, net of issuance costs of $ 166
+Added: Proceeds from 2024 private placement, net of issuance costs of $ 6,498
+Added: Payment of issuance costs for shares issued under 2024 private placement
+Added: Proceeds from borrowings under Credit Facility (Note 13)
+Added: Proceeds from exercise of stock options
+Added: Proceeds from issuance of common stock under employee stock purchase plan
+Added: Net cash provided by financing activities
+Added: Net (decrease) increase in cash and cash equivalents
+Added: Cash and cash equivalents at beginning of period
+Added: Cash and cash equivalents at end of period
+Added: Supplemental disclosure of cash flow information
+Added: Exchange common stock shares for pre-funded warrants
+Added: Right-of-use asset obtained in exchange for operating lease liabilities
+Added: Unpaid issuance costs related to follow-on public offering and 2024 private placement
+Added: Research and development project deposit applied against study invoices
+Added: System implementation cost included in other current liabilities
+Added: See accompanying notes to the consolidated financial statements.
+Added: Olema Pharmaceuticals, Inc.
+Added: Notes to Consolidated Financial Statements
+Added: Nature of the Business and Basis of Presentation
+Added: Olema Pharmaceuticals, Inc.
+Added: (“Olema” or the “Company”) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of next-generation targeted therapies for women’s cancers.
+Added: The Company is advancing a pipeline of novel therapies by leveraging its deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance.
+Added: The Company's wholly-owned, lead product candidate, palazestrant (OP-1250), is a novel, orally-available small molecule with dual activity as both a complete estrogen receptor ("ER") antagonist ("CERAN") and selective ER degrader ("SERD").
+Added: In addition to its lead product candidate, Olema is developing a potent KAT6 inhibitor (OP-3136).
+Added: The Company is located in San Francisco, California and was incorporated in Delaware on August 7, 2006, under the legal name of CombiThera, Inc.
+Added: and on March 25, 2009, was renamed Olema Pharmaceuticals, Inc.
+Added: The Company’s principal operations are based in San Francisco, California, and it has operations in Cambridge, Massachusetts.
+Added: Olema Oncology Australia Pty Ltd, incorporated on January 6, 2021 under the laws of Australia, and Olema Oncology International Limited, incorporated on December 11, 2025 under the laws of Ireland , are wholly-owned subsidiaries of the Company (collectively with Olema Pharmaceuticals, Inc., referred to as “Olema” or the “Company” herein).
+Added: It operates in one business segment and therefore has only one reportable segment.
+Added: 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.
+Added: 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.
+Added: These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities.
+Added: 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.
+Added: The Company had $ 505.4 million of cash, cash equivalents and marketable securities at December 31, 2025, in addition to the available balance 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 (the "First Amendment"), as further amended by the Second Amendment to Loan and Security Agreement, dated June 27, 2025 (the "Second Amendment"), as further amended by the Third Amendment to Loan and Security Agreement, dated January 11, 2026 (the "Third Amendment" and, collectively with the First Amendment, Second Amendment and the Original Loan Agreement, the "Loan Agreement").
+Added: See Note 13, "Long-term Borrowing" for further details.
+Added: 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 consolidated financial statements.
+Added: Follow-on Public Offering
+Added: On November 19, 2025, the Company completed a follow-on public offering pursuant to which we issued and sold 11,500,000 shares of common stock at a public offering price of $ 19.00 per share, including 1,500,000 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares, resulting in aggregate net proceeds of $ 204.8 million, after deducting underwriting discounts and commissions and estimated offering costs.
+Added: Private Placement
+Added: On November 29, 2024, the Company entered into a securities purchase agreement for a private placement of (i) 19,928,875 shares of the Company’s 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 the Company's common stock at a price of $ 9.0799 per pre-funded warrant, which represents the per share purchase price of the Company's 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”).
+Added: The aggregate gross proceeds for the 2024 Private Placement were approximately $ 250.0 million.
+Added: After deducting offering expenses related to the 2024 Private Placement of approximately $ 13.0 million , the net proceeds to the Company from the 2024 Private Placement were approximately $ 237.0 million.
+Added: Warrant Exchanges
+Added: 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 "Exchange Transactions").
+Added: 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.
+Added: Refer to Note 7.
+Added: Common Stock for further details.
+Added: At-The-Market Offering
+Added: On January 5, 2024, the Company entered into a sales agreement (the “2024 Sales Agreement”) with Cowen and Company, LLC ("Cowen and Company”) as sales agent, pursuant to which the Company was permitted to offer and sell, from time to time, shares of its common stock, having an aggregate offering price of up to $ 150.0 million (the “2024 ATM Shares”).
+Added: The sales of the 2024 ATM Shares were made by an "at-the-market" ("ATM") equity offering as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended ("Securities Act").
+Added: The Company agreed to pay Cowen and Company a commission of up to 3.0 % of the aggregate gross proceeds from any 2024 ATM Shares sold by Cowen and Company.
+Added: During the year ended December 31, 2024, the Company issued 1,772,278 shares of the Company's 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.
+Added: 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 was permitted to 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”).
+Added: The 2025 Sales Agreement replaced the prior 2024 Sales Agreement.
+Added: The sales of the 2025 ATM Shares would be made by any method permitted that is deemed to be an ATM 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.
+Added: The Company 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.
+Added: On December 11, 2025, the Company entered into Amendment No.
+Added: 1 to the 2025 Sales Agreement which increased the maximum aggregate offering price under the 2025 Sales Agreement to $ 200.0 million.
+Added: As of December 31, 2025, no securities had been sold under the 2025 Sales Agreement.
+Added: Impact of Geopolitical and Macroeconomic Events
+Added: 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 (including related legal challenges) , tariffs, trade tensions and retaliatory measures by other countries, supply chain disruptions, military conflicts, 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.
+Added: 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.
+Added: Any continued or renewed disruption resulting from these factors could negatively impact the Company’s business.
+Added: The Company continues to monitor the impact of these geopolitical and macroeconomic factors on its results of operations, financial condition and cash flows.
+Added: Summary of Significant Accounting Policies
+Added: Basis of Presentation and Consolidation
+Added: The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) regarding financial reporting, and the instructions to Form 10-K and Article 10 of Regulation S-X.
+Added: These consolidated financial statements include the accounts of Olema Pharmaceuticals, Inc.
+Added: and its wholly-owned subsidiaries, Olema Oncology Australia Pty Ltd and Olema Oncology International Limited.
+Added: All intercompany balances and transactions have been eliminated upon consolidation.
+Added: Use of Estimates
+Added: The accompanying consolidated financial statements are prepared in accordance with GAAP.
+Added: The preparation of the 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 consolidated financial statements and reported amounts of expenses during the reporting period.
+Added: 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.
+Added: 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.
+Added: Actual results could differ from those estimates.
+Added: Cash and Cash Equivalents
+Added: 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.
+Added: Cash deposits are all in reputable financial institutions in the United States as of December 31, 2025 and 2024 .
+Added: Cash and cash equivalents primarily consisted of cash on deposit with U.S.
+Added: banks, including the Company’s bank account for its Australia subsidiary, denominated in U.S.
+Added: dollars and Australian dollars, and investments in interest-bearing money market funds.
+Added: Marketable Securities
+Added: All marketable securities have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities.
+Added: Management determines the appropriate classification of its investments at the time of purchase and reevaluates such designation as of each balance sheet date.
+Added: Unrealized gains and losses are excluded from net loss and are reported as a component of comprehensive loss.
+Added: Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest income.
+Added: The cost of securities sold is based on the specific-identification method.
+Added: Interest earned on marketable securities is included in interest income.
+Added: The Company periodically assesses its available-for-sale marketable securities for other-than-temporary impairment.
+Added: For debt securities in an unrealized loss position, the Company first considers its intent to sell, or whether it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis.
+Added: If either of these criteria are met, the amortized cost basis of such debt securities is written down to fair value through other expense.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded through other expense, limited by the amount that the fair value is less than the amortized cost basis.
+Added: Any additional impairment not recorded through an allowance for credit losses is recognized in other comprehensive loss.
+Added: The Company has not recorded any impairments for its marketable securities.
+Added: Concentration of Credit Risk and Other Risks and Uncertainties
+Added: Financial instruments that potentially subject the Company to concentration of credit risk consist of cash, cash equivalents, and marketable securities.
+Added: The Company invests in a variety of financial instruments and, by its policy, limits these financial instruments to high credit quality securities issued by the U.S.
+Added: government, U.S.
+Added: government-sponsored agencies and highly rated banks and corporations, subject to certain concentration limits.
+Added: The Company’s cash, cash equivalents, and marketable securities are held by financial institutions in the United States that management believes are of high credit quality.
+Added: Amounts on deposit with individual banking institutions may at times exceed the limits insured by the Federal Deposit Insurance Corporation;
+Added: however, the Company has not experienced any losses on such deposits.
+Added: The Company’s future results of operations involve a number of other risks and uncertainties.
+Added: 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.
+Added: The Company’s product candidates require approvals from the U.S.
+Added: Food and Drug Administration and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions.
+Added: There can be no assurance that any product candidates will receive the necessary approvals.
+Added: 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.
+Added: 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:
+Added: (1) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis;
+Added: and (2) a right-of-use (“ROU”) asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term.
+Added: Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the consolidated statements of operations and comprehensive loss.
+Added: At the inception of an arrangement, the Company determines if an arrangement is, or contains, a lease based on the facts and circumstances present in that arrangement.
+Added: Lease classification, recognition, and measurement are then determined at the lease commencement date.
+Added: For arrangements that contain a lease, the Company (i) identifies lease and non-lease components, (ii) determines the consideration in the contract, (iii) determines whether the lease is an operating or finance lease;
+Added: and (iv) recognizes lease ROU assets and liabilities.
+Added: Lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected lease term.
+Added: The interest rate implicit in lease contracts is typically not readily determinable, and as such, the Company uses the incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment.
+Added: Most leases include options to renew or terminate the lease, which can impact the lease term.
+Added: The exercise of these options is at the Company’s discretion.
+Added: 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.
+Added: 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.
+Added: The Company has operating leases for its research and development and office facilities.
+Added: Fixed lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis.
+Added: Variable lease expenses that are not considered fixed are recognized as incurred.
+Added: Fixed and variable lease expense on operating leases is recognized within operating expenses within our consolidated statements of operations and comprehensive loss.
+Added: The Company elected to not apply the recognition requirements of Topic 842 to short-term leases with terms of 12 months or less.
+Added: Refer to Note 11, Leases for further details.
+Added: Research and Development Costs
+Added: Research and development costs are expensed as incurred.
+Added: Research and development expenses consist of costs incurred to discover, research and develop product candidates.
+Added: These costs are recorded within research and development expenses in the 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.
+Added: Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as either prepaid expenses and other current assets or other assets and long-term deposits.
+Added: Such amounts are recognized as an expense as the goods are delivered or the related services are performed.
+Added: 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.
+Added: Reimbursements of certain costs associated with research activities performed under the agreement with Novartis Institutes for BioMedical Research, Inc.
+Added: 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 consolidated financial statements, as described in Note 12, Commitments and Contingencies – 2020 Clinical Collaboration and Supply Agreement.
+Added: Research Contract Costs and Accruals
+Added: The Company has, from time to time, entered into various research and development and other agreements with commercial firms, researchers, universities and others for provisions of goods and services.
+Added: These agreements are generally cancelable, and the related costs are recorded as research and development expenses as incurred.
+Added: The Company records accruals for estimated ongoing research and development costs.
+Added: When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the projects, studies or clinical trials, including the phase or completion of events, invoices received and contracted costs.
+Added: Judgments and estimates are made in determining the accrued balances at the end of any reporting period.
+Added: Actual results could differ materially from the Company’s estimates.
+Added: The Company’s historical accrual estimates have not been materially different from the actual costs.
+Added: Internal-Use Software
+Added: The Company capitalizes certain costs incurred for the development and implementation of computer software for internal use.
+Added: These costs generally relate to the implementation of the third-party developed software for the Company's clinical development purposes.
+Added: 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.
+Added: Capitalized internal-use software development and implementation costs are included in Other assets and long-term deposits within the consolidated balance sheets.
+Added: Capitalized implementation costs are amortized on a straight-line basis over the estimated useful lives of five years .
+Added: Costs related to the preliminary project stage, post-implementation, training and maintenance are expensed as incurred.
+Added: Income taxes are computed using the asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company’s consolidated financial statements.
+Added: In estimating future tax consequences, the Company considers all expected future events other than enactment of changes in tax laws or rates.
+Added: A valuation allowance is recorded, if necessary, to reduce net deferred tax assets to their realizable values if management does not believe it is more likely than not that the net deferred tax assets will be realized.
+Added: As of December 31, 2025 and 2024, the Company has recorded a full valuation allowance against its net deferred tax assets.
+Added: The Company had no unrecognized tax benefits for the years ended December 31, 2025 and 2024, respectively.
+Added: The Company may be subject to U.S.
+Added: Federal, state, and local tax examinations by tax authorities for years before 2025, which may include adjustments to carry-forward attributes (see Note 9, “Income Taxes”).
+Added: The Company’s policy is to recognize interest and penalties related to uncertain tax positions in the provision for income taxes.
+Added: As of December 31, 2025 and 2024, the Company had no accrued interest or penalties related to uncertain tax positions.
+Added: Comprehensive Loss
+Added: Comprehensive loss includes net loss and other comprehensive (loss) income for each period presented.
+Added: Other comprehensive (loss) income represents net unrealized (loss) gain on marketable securities.
+Added: Stock-Based Compensation
+Added: Stock-based compensation cost, including grants of stock options and restricted stock awards issued under the Company’s equity incentive plans and the 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.
+Added: 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.
+Added: The Company recognizes stock compensation in accordance with Accounting Standards Codification ("ASC") 718, Compensation — Stock Compensation (“ASC 718”).
+Added: 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.
+Added: The Company estimates volatility using stock prices of peer companies and its historical data, risk-free rates using the implied yield currently available on U.S.
+Added: Treasury zero-coupon issues with a remaining term equal to the expected term, and dividend yield using the Company’s expectations and historical data.
+Added: The Company uses the simplified method to calculate the expected term of employee stock option grants.
+Added: Under the simplified method, the expected term is estimated to be the mid-point between the vesting date and the contractual term of the option.
+Added: For awards with graded vesting, in which specified tranches of the options vest on different dates, the Company uses a single weighted average expected life to value the entire award, which is equal to the average of the weighted average vesting period of the award and the contractual term of the award.
+Added: The amount of stock-based compensation expense recognized during a period is based on the value of the portion of the awards that are ultimately expected to vest, including awards with graded vesting.
+Added: As part of the requirements of ASC 718, the Company has elected to account for forfeitures of stock option grants as they occur.
+Added: Foreign Currency Transactions
+Added: The functional currency of Olema Oncology Australia Pty Ltd and Olema Oncology International Limited, the Company’s wholly-owned subsidiaries, is the U.S.
+Added: Accordingly, all monetary assets and liabilities of the subsidiary are remeasured into U.S.
+Added: dollars at the current period-end exchange rates and non-monetary assets are remeasured using historical exchange rates.
+Added: Income and expense elements are remeasured to U.S.
+Added: dollars using the average exchange rates in effect during the period.
+Added: Remeasurement gains and losses are recorded as other income (expense) on the consolidated statements of operations.
+Added: The Company is subject to foreign currency risk with respect to its clinical and manufacturing contracts denominated in currencies other than the U.S.
+Added: dollar, predominantly the Australian dollar and the Euro.
+Added: Payments on contracts denominated in foreign currencies are made at the spot rate on the day of payment.
+Added: Changes in the exchange rate between billing dates and payment dates are recorded within other income (expense) on the consolidated statements of operations.
+Added: Pre-funded Warrants
+Added: The Company issued pre-funded warrants in connection with the 2024 Private Placement and the Exchange Transactions executed in November 2024 and January 2025.
+Added: Refer to Note 7, Common Stock for further details.
+Added: 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, Distinguishing Liabilities from Equity ("ASC 480"), and ASC 815, Derivatives and Hedging ("ASC 815").
+Added: Accordingly, the Company recorded the pre-funded warrants as a component of stockholders' equity within additional paid-in capital.
+Added: The Company valued the pre-funded warrants at issuance, concluding that their sales price approximated their fair value.
+Added: The pre-funded warrants are immediately exercisable at an exercise price of $ 0.0001 per share of the Company's common stock, subject to beneficial ownership limitations.
+Added: 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.
+Added: 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.
+Added: Net Loss Per Common Share
+Added: 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.
+Added: Diluted net loss per common share is computed by adjusting net loss to reallocate undistributed earnings based on the potential impact of dilutive securities, and by dividing the diluted net loss by the weighted average number of common shares outstanding for the period, including the pre-funded warrants shares and potential dilutive common shares.
+Added: For purpose of this calculation, outstanding stock options and contingently issuable common stock related to the ESPP are considered potential dilutive common shares.
+Added: 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.
+Added: Segment Reporting
+Added: 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.
+Added: Accordingly, the Company's CODM uses consolidated net loss to measure segment loss, allocate resources and assess performance.
+Added: 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.
+Added: Other segment items included in consolidated net loss is interest income, which is reflected in the consolidated statements of operations and comprehensive loss.
+Added: Recent Accounting Pronouncements Adopted
+Added: In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.
+Added: 2023 09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures.
+Added: The ASU enhances the transparency and decision usefulness of income tax disclosures by requiring additional disaggregation of information related to the effective tax rate reconciliation, income taxes paid, and income tax expense and pretax income by jurisdiction.
+Added: The Company adopted ASU 2023-09 on a prospective basis effective January 1, 2025 .
+Added: Accordingly, the enhanced income tax disclosures are presented beginning in fiscal year 2025, and prior period disclosures have not been recast.
+Added: The adoption of this guidance did not have an impact on the Company’s consolidated results of operations, financial position, or cash flows, as the amendments relate solely to disclosure requirements.
+Added: The related enhanced disclosures are included in Note 9.
+Added: Income Taxes.
+Added: Recent Accounting Pronouncements Not Yet Adopted
+Added: In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses , which requires public business entities to provide enhanced disclosures about specific expense categories in both interim and annual financial statements.
+Added: The new standard requires entities to disclose in tabular format certain categories of expenses, including purchases of inventory, employee compensation, depreciation, intangible asset amortization, and other specified expense categories, along with a qualitative description of amounts remaining in relevant expense captions.
+Added: The objective of this ASU is to provide investors with more detailed information to better assess an entity's performance and future cash flow prospects.
+Added: As clarified by ASU 2025-01 issued in January 2025, ASU 2024-03 is effective for public business entities for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027.
+Added: Early adoption is permitted.
+Added: The Company is currently evaluating the impact of this standard on its consolidated financial statement disclosures.
+Added: In September 2025, the FASB issued ASU 2025-06, Targeted Improvements to the Accounting for Internal-Use Software , which modernizes the accounting guidance for costs associated with developing or obtaining internal-use software.
+Added: The ASU eliminates the previous stage-based model (preliminary project stage, application development stage, and post-implementation stage) and replaces it with a principles-based approach that better aligns with modern software development practices, including agile and iterative methodologies.
+Added: Under the new guidance, entities may begin capitalizing internal-use software development costs when (1) management has authorized and committed to funding the software project, and (2) it is probable that the project will be completed and the software will be used to perform the function intended.
+Added: The ASU also supersedes the separate guidance on website development costs and incorporates it into the internal-use software framework.
+Added: ASU 2025-06 is effective for all entities for annual reporting periods beginning after December 15, 2027, and interim reporting periods within those annual reporting periods.
+Added: Early adoption is permitted as the beginning of an annual reporting period.
+Added: The Company is evaluating the impact of this standard on its consolidated financial statements.
+Added: The Company continues to monitor new accounting pronouncements issued by the FASB and does not believe that any pronouncements issued but not yet adopted as of the date of this report will have a material impact on the Company’s consolidated financial statements.
+Added: Fair Value Measurement
+Added: The Company assesses the fair value of financial instruments based on the provisions of ASC 820, Fair Value Measurements .
+Added: ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
+Added: ASC 820 also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
+Added: The standard describes three levels of inputs that may be used to measure fair value:
+Added: • Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date.
+Added: • Level 2 — Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
+Added: • 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.
+Added: December 31, 2025
+Added: (in thousands)
+Added: Financial Assets
+Added: Money market funds
+Added: Commercial paper
+Added: Corporate bonds
+Added: government treasury bills
+Added: Government-sponsored enterprise securities
+Added: December 31, 2025
+Added: (in thousands)
+Added: Financial Assets
+Added: Cash and cash equivalents
+Added: Short-term marketable securities (<12 months to maturity)
+Added: Long-term marketable securities (>12 months to maturity)
+Added: December 31, 2024
+Added: (in thousands)
+Added: Financial Assets
+Added: Money market funds
+Added: Commercial paper
+Added: Corporate bonds
+Added: government treasury bills
+Added: Government-sponsored enterprise securities
+Added: December 31, 2024
+Added: (in thousands)
+Added: Financial Assets
+Added: Cash and cash equivalents
+Added: Short-term marketable securities (<12 months to maturity)
+Added: Long-term marketable securities (>12 months to maturity)
+Added: The Company considers its marketable securities with maturities beyond one year as current assets, based on their highly liquid nature and because such marketable securities represent the investment of cash that is available for current operations.
+Added: The Company considers its investment portfolio of marketable securities to be available-for-sale.
+Added: The Company periodically reviews its available-for-sale marketable securities for other-than-temporary impairment.
+Added: 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.
+Added: 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.
+Added: There were no marketable securities that have been in a consecutive loss position for more than 12 months as of December 31, 2025.
+Added: During the year ended December 31, 2025, the Company did not recognize any other-than-temporary impairment loss.
+Added: As of December 31, 2025 , there was no allowance for losses on available-for-sale debt securities attributable to credit risk.
+Added: As of December 31, 2025 , all of the Company’s cash and cash equivalents primarily consisted of cash on deposit with U.S.
+Added: banks denominated in U.
+Added: dollars and Australian dollars, and investments in interest-bearing money market funds.
+Added: Prepaid Expenses and Other Current Assets
+Added: Prepaid expenses and other current assets consisted of the following (in thousands):
+Added: Interest receivable
+Added: Prepaid clinical development costs
+Added: Prepaid subscriptions and licenses
+Added: Prepaid insurance
+Added: Value added tax receivable
+Added: ¹ Other current assets included a $ 0.5 million tax refund receivable from the Australian Taxation Office related to the 2025 calendar year, which was received in February 2026.
+Added: Other Assets and Long-Term Deposits
+Added: Other assets and long-term deposits consisted of the following (in thousands):
+Added: Clinical development project deposits
+Added: System implementation costs
+Added: Office lease deposits
+Added: Property and equipment, net
+Added: Other Current Liabilities
+Added: Other current liabilities consisted of the following (in thousands):
+Added: Accrued research and development related costs
+Added: Accrued employee bonuses
+Added: Accrued corporate related costs
+Added: Accrued payroll related costs
+Added: As of each of the balance sheet dates below, the Company had reserved shares of common stock for issuance in connection with the following:
+Added: Options outstanding under the 2014 Stock Plan
+Added: Options outstanding under the 2020 Equity Incentive Plan
+Added: Options outstanding under the 2022 Inducement Plan
+Added: Shares available for future grant under the 2020 Equity Incentive Plan and the 2022 Inducement Plan
+Added: Available for the ESPP
+Added: Shares available for issuance related to pre-funded warrants
+Added: Pre-Funded Warrants
+Added: In December 2024, the Company issued pre-funded warrants to purchase up to 7,604,163 shares of the Company's common stock in connection with the 2024 Private Placement at $ 9.07998 per share of the common stock, less the $ 0.0001 per share exercise price of each warrant.
+Added: In November 2024 and January 2025, the Company entered into the Exchange Transactions with certain investors and issued to such investors pre-funded warrants to purchase up to 3,420,000 and 6,070,000 shares of its common stock, respectively, at an exercise price of $ 0.0001 per share, in exchange for an equivalent number of shares of the Company's common stock previously outstanding and held by such investors.
+Added: The pre-funded warrants were issued without registration under the Securities Act, in reliance on the exemption from registration contained in Section 3(a)(9) of the Securities Act.
+Added: The Company accounted 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.
+Added: Accordingly, the Company recorded the pre-funded warrants as a component of stockholders' equity within additional paid-in capital.
+Added: The following table summarizes the pre-funded warrants issued as of December 31, 2025:
+Added: Expiration Date
+Added: Exercise Price
+Added: Number of Warrants Outstanding
+Added: 2024 (Private Placement)
+Added: 2024 (Warrant Exchange Agreement)
+Added: 2025 (Warrant Exchange Agreement)
+Added: Stock-Based Compensation
+Added: In 2014, the Company’s Board of Directors (the “Board”) and stockholders approved and adopted the Company’s 2014 Stock Plan (the “2014 Plan”).
+Added: The 2014 Plan permitted the grant of options and restricted stock awards (including restricted stock purchase rights and restricted stock bonus awards).
+Added: 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.
+Added: 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.
+Added: In 2020, the Board and the Company’s stockholders approved and adopted the 2020 Plan.
+Added: The 2020 Plan permits the grant of options, restricted stock awards, stock appreciation rights, restricted stock unit awards, performance awards, and other awards.
+Added: The maximum number of shares of common stock that were initially issuable under the 2020 Plan was a number not to exceed 6,494,510 shares of the Company’s common stock, which is the sum of (i) 2,152,080 new shares, plus (ii) an additional number of shares not to exceed 4,342,430 shares, consisting of any shares of the Company’s common stock subject to outstanding stock options or other stock awards granted under the 2014 Plan that, on or after the date on which the 2020 Plan became effective, terminated or expired prior to exercise or settlement;
+Added: were not issued because the award was settled in cash;
+Added: were forfeited because of the failure to vest;
+Added: or were reacquired or withheld (or not issued) to satisfy a tax withholding obligation or the purchase or exercise price.
+Added: In addition, the number of shares of the Company’s common stock reserved for issuance under the 2020 Plan automatically increases on January 1 of each year for a period of ten years , beginning on January 1, 2021 and continuing through January 1, 2030, in an amount equal to the lesser of (1) 5 % of the total number of shares of the Company’s common stock outstanding on December 31 of the immediately preceding year, or (2) a lesser number of shares determined by the Board no later than December 31 of the immediately preceding year.
+Added: In 2022, the Board approved and adopted the Company’s 2022 Inducement Plan (the “2022 Inducement Plan”).
+Added: Under the 2022 Inducement Plan, initially 2,000,000 shares of common stock were reserved for issuance.
+Added: 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.
+Added: Th e 2022 Inducement Plan permits the grant of options, restricted stock awards, stock appreciation rights, restricted stock unit awards, performance awards, and other awards.
+Added: The exercise price for each option and stock appreciation right shall be established at the discretion of the Board, provided that the exercise price of a stock option will not be less than 100 % of the fair market value of the Company’s common stock on the date of grant.
+Added: Specific vesting for stock options and stock appreciation rights is service related and determined in each award agreement, where stock options and stock appreciation rights are fully vested at the grant date or follow a graded vesting schedule.
+Added: Stock options and stock appreciation rights granted under the plans generally expire ten years after the date of grant.
+Added: Stock Option Valuation
+Added: The fair value of stock option grants is estimated using the Black-Scholes option-pricing model.
+Added: The Company lacks company-specific historical and implied volatility information.
+Added: Therefore, it estimated its expected stock volatility based on the historical volatility of a publicly traded set of peer companies in addition to its own historical volatility.
+Added: For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options.
+Added: The risk-free interest rate is determined by reference to the U.S.
+Added: Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award.
+Added: The expected dividend yield is 0 % since the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
+Added: 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:
+Added: Years Ended December 31,
+Added: Risk-free interest rate
+Added: Expected term (in years)
+Added: Expected volatility
+Added: Expected dividend yield
+Added: Stock Option Activity
+Added: The following table summarizes the stock option activity under the 2014 Plan, the 2020 Plan and the 2022 Inducement Plan:
+Added: (in thousands)
+Added: Outstanding as of December 31, 2024
+Added: Forfeited and cancelled
+Added: Outstanding as of December 31, 2025
+Added: Options vested and exercisable as of December 31, 2025
+Added: Options expected to vest as of December 31, 2025
+Added: (1) Exercised amount includes shares returned for taxes withheld for exercise and net transactions.
+Added: The weighted-average grant-date fair value per share of options granted during the years ended December 31, 2025 and 2024 was $ 3.56 and $ 10.40 , respectively.
+Added: For the years ended December 31, 2025 and 2024 , there were 2,519,878 and 2,213,715 shares vested, respectively.
+Added: The weighted-average grant-date fair value per share of options vested during the years ended December 31, 2025 and 2024 was $ 7.93 and $ 6.58 , respectively.
+Added: The total fair value of options vested during the years ended December 31, 2025 and 2024 was $ 20.0 million and $ 14.6 million, respectively.
+Added: The aggregate intrinsic value of options exercised during the years ended December 31, 2025 and 2024 was $ 24.2 million and $ 3.3 million, respectively.
+Added: As of December 31, 2025 , the total unrecognized compensation expense related to unvested options was $ 32.1 million, which the Company expects to recognize over an estimated weighted average period of 2.58 years.
+Added: Restricted Stock Awards
+Added: Restricted stock awards ("RSAs") granted under the 2014 Plan were fully vested as of December 31, 2024.
+Added: The total grant-date fair value of RSAs that vested during 2024 was $ 0.2 million, which was recognized as stock-based compensation expense during that period.
+Added: As of December 31, 2024, there was no unrecognized compensation expense related to RSAs.
+Added: Performance-Based Restricted Stock Unit Awards
+Added: 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 grant-date fair value measured using the closing price of the Company's common stock.
+Added: Vesting of the awards was contingent upon certification by the Compensation Committee of the achievement of defined performance goals.
+Added: Under the original terms, 35 % and 65 % of the PSUs were eligible to vest upon achievement of performance goals by June 30, 2024.
+Added: The performance condition for the 35 % tranche was achieved and certified in 2023, and the related stock-based compensation expense of $ 0.7 million was recognized in that period.
+Added: In June 2024, the Compensation Committee extended the performance period for the remaining 65 % tranche to December 31, 2024.
+Added: The performance goal for this tranche was achieved and certified as of December 31, 2024, resulting in $ 1.4 million of stock-based compensation expense recognized in 2024.
+Added: All PSUs were fully vested as of December 31, 2024.
+Added: 2020 Employee Stock Purchase Plan
+Added: In 2020, the Board and the Company’s stockholders approved and adopted the ESPP.
+Added: The ESPP permits eligible employees who elect to participate in an offering under the ESPP to have up to 15 % of their eligible earnings withheld, subject to certain limitations, to purchase shares of common stock pursuant to the ESPP.
+Added: The price of the common stock purchased under the ESPP is equal to the lesser of (i) 85 % of the fair market value of a share of the Company’s common stock on the first day of an offering;
+Added: or (ii) 85 % of the fair market value of a share of the Company’s common stock on the date of purchase.
+Added: Each offering period is not to exceed 27 months and will include one or more purchase periods (each a Purchase Period) as approved by the Board in the offering.
+Added: A total of 430,416 shares of common stock were initially reserved for issuance pursuant to the ESPP.
+Added: Subsequently, the number of shares of the Company’s common stock reserved for issuance under the ESPP automatically increases on January 1 of each year for a period of up to ten years , commencing on January 1, 2021 and continuing through January 1, 2030, in amount equal to the lesser of (i) 1 % of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, (ii) 860,832 shares of common stock, or (iii) a lesser number of shares determined by the Board no later than December 31 of the preceding calendar year.
+Added: The ESPP is a compensatory plan as defined by the authoritative guidance for stock-based compensation.
+Added: The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock offered under the ESPP.
+Added: Stock-based compensation expense related to the ESPP was $ 0.5 million and $ 0.6 million for the years ended December 31, 2025 and 2024, respectively.
+Added: Stock-Based Compensation Expense
+Added: 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 consolidated statements of operations and comprehensive loss as follows (in thousands):
+Added: Years Ended December 31,
+Added: Research and development
+Added: General and administrative
+Added: The Company is incorporated in the United States and operates a wholly owned subsidiary in Australia and is subject to both U.S.
+Added: and Australia tax laws and rates.
+Added: A portion of the Company's loss before taxes and the provision for income taxes is generated from the Company's Australian operation.
+Added: Loss before income taxes for the years ended December 31, 2025 and 2024 is summarized as follows (in thousands):
+Added: Years Ended December 31,
+Added: Total loss before income taxes
+Added: The following table is a reconciliation of the U.S.
+Added: federal statutory income tax rate of 21 % to the Company's effective income tax rate for the year ended December 31, 2025 in accordance with ASU 2023-09 (in thousands, except for percentages):
+Added: Year Ended December 31, 2025
+Added: federal statutory tax rate
+Added: State and local income taxes, net of federal income tax effect (a)
+Added: Foreign tax effects:
+Added: Statutory tax rate difference between Australia and United States
+Added: Research and development expenses
+Added: Research and development credits
+Added: Changes in valuation allowance
+Added: Aquired intangible
+Added: Changes in valuation allowance
+Added: Effect of cross-border tax laws:
+Added: Global intangible low-taxes income
+Added: Changes in valuation allowance
+Added: Nontaxable or nondeductible items:
+Added: Gain from intellectual property transfer
+Added: Share-based payment awards
+Added: Income tax expense and effective income tax rate
+Added: (a) State and local income taxes, net of federal income tax effect, reflect minimum state taxes and were not material to the effective tax rate for the period.
+Added: Income taxes paid during the period consisted solely of minimum state income taxes and were not material.
+Added: No disaggregation of income taxes paid by jurisdiction has been provided.
+Added: As previously disclosed for the year ended December 31, 2024 prior to the adoption of ASU 2023-09, the following table is a reconciliation of the U.S.
+Added: federal statutory income tax provision to the Company's effective income tax provision (in thousands):
+Added: Year Ended December 31, 2024
+Added: Federal statutory income tax
+Added: State income taxes, net of federal tax benefit
+Added: Foreign research and development tax credit
+Added: Permanent differences in non-tax-deductible executive compensation
+Added: Permanent differences in foreign jurisdiction
+Added: Permanent differences others
+Added: Other deferred items
+Added: Valuation allowance
+Added: Net expense for income taxes
+Added: Deferred income taxes reflect the net tax effects of loss and credit carryforwards and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
+Added: The Company’s deferred income tax assets and liabilities as of December 31, 2025 and 2024 were comprised of the following (in thousands):
+Added: As of December 31,
+Added: Deferred tax assets:
+Added: Net operating loss carryforwards
+Added: Capitalized research and development
+Added: Equity compensation
+Added: Lease liability
+Added: Foreign R&D tax credits
+Added: Acquired intangible
+Added: Total deferred tax assets
+Added: Deferred tax liabilities:
+Added: Right-of-use assets
+Added: Total deferred tax liabilities
+Added: Valuation allowance
+Added: Net deferred tax assets
+Added: In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized.
+Added: The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible.
+Added: Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment.
+Added: Based on the level of historical operating results and the uncertainty of the economic conditions, the Company has recorded a valuation allowance of $ 143.4 million and $ 104.5 million as of December 31, 2025 and 2024, respectively.
+Added: The change in the valuation allowance for the year end December 31, 2025 was an increase of $ 38.9 million.
+Added: As of December 31, 2025 and 2024, the Company had Federal net operating losses ("NOLs") of approximately $ 305.0 million and $ 190.2 million, and state NOLs of $ 398.8 million and $ 296.7 million, respectively.
+Added: As a result of the Tax Cuts and Jobs Act, for U.S.
+Added: income tax purposes, NOLs generated in tax years beginning before January 1, 2018 can still be carried forward for up to 20 years , but net operating losses generated for tax years beginning after December 31, 2017 may be carried forward indefinitely and can be used to offset taxable income, but the deductibility of such Federal NOLs may be limited to 80 % of current year taxable income for tax years beginning on or after December 31, 2025.
+Added: Of the total Federal NOLs of $ 305.0 million, $ 3.3 million will begin to expire in 2032 and $ 301.7 million will not expire.
+Added: The state NOL carryover of $ 398.8 million will begin to expire in 2032.
+Added: Pursuant to Internal Revenue Code (IRC) Sections 382 and 383, annual use of the Company’s net operating loss and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period.
+Added: The Company has not completed an ownership change analysis pursuant to IRC Section 382.
+Added: If ownership changes within the meaning of IRC Section 382 are identified as having occurred, the amount of remaining tax attribute carryforwards available to offset future taxable income and income tax expense in future years may be significantly restricted or eliminated.
+Added: Further, the Company’s deferred tax assets associated with such tax attributes could be significantly reduced upon realization of an ownership change within the meaning of IRC Section 382 that has occurred or may occur in the future.
+Added: Any adjustment to the Company’s tax attributes as a result of an ownership change will result in a corresponding decrease to the valuation allowance recorded against the Company’s deferred tax assets.
+Added: The Company’s valuation allowance increased during the years ended December 31, 2025 and 2024 due primarily to the generation of net operating losses, as follows (in thousands):
+Added: Years Ended December 31,
+Added: Valuation allowance at beginning of year
+Added: Increase recorded to provision for income taxes
+Added: Valuation allowance at end of year
+Added: The Company has not incurred any material interest or penalties as of the current reporting date with respect to income tax matters.
+Added: The Company does not expect that there will be unrecognized tax benefits within 12 months of the reporting date.
+Added: The Company is subject to U.S.
+Added: Federal and state income taxes.
+Added: The Federal and state income tax returns for tax years prior to 2024 may remain open to examination as carry-forward attributes generated prior may be adjusted upon examination.
+Added: Net Loss Per Common Share
+Added: Net Loss Per Common Share
+Added: Basic and diluted net loss per common share was calculated as follows (in thousands, except share and per share amounts):
+Added: Years Ended December 31,
+Added: Weighted average shares used to compute net loss per share, basic and diluted¹
+Added: Net loss per share, basic and diluted
+Added: ¹ For the years ended December 31, 2025 and 2024, the weighted average shares used to compute net loss per share, basic and diluted, include the pre-funded warrants.
+Added: 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:
+Added: Years Ended December 31,
+Added: Options to purchase common stock
+Added: The Company leases certain of its facilities under non-cancellable operating leases expiring at various dates into 2027.
+Added: 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").
+Added: The Laboratory Lease Agreement was for a period of five years commencing approximately February 1, 2021 and ending January 31, 2026 .
+Added: In April 2025, the Company exercised its option to extend the lease term by an additional year, resulting in a revised expiration date of January 31, 2027 .
+Added: The modification was accounted under ASC 842, resulting in a remeasurement of the lease liability and a corresponding $ 0.8 million increase to the ROU asset.
+Added: The incremental borrowing rate was also updated as part of the remeasurement.
+Added: According to the terms of the Laboratory Lease Agreement, the Company paid a $ 0.4 million security deposit and is required to pay monthly rent and common area charges.
+Added: No additional security deposit was paid in connection with the amendment.
+Added: On August 17, 2023, the Company entered into a sublease agreement with Dropbox, Inc.
+Added: to sublease approximately 6,713 square feet of office space in San Francisco, California (the "Dropbox Sublease Agreement").
+Added: The Dropbox Sublease Agreement was for a period of two years commencing on September 5, 2023 and ending December 31, 2025 .
+Added: In June 2025, the Company exercised its option to extend the lease term by an additional year, resulting in a revised expiration date of December 31, 2026 .
+Added: The modification was accounted under ASC 842, resulting in a remeasurement of the lease liability and a corresponding $ 0.1 million increase to the ROU asset.
+Added: The incremental borrowing rate was also updated as part of the remeasurement.
+Added: 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.
+Added: On August 23, 2023, the Company entered into a lease agreement with The Cambridge Redevelopment Authority to lease approximately 4,020 square feet of office space in Cambridge, Massachusetts (the "Cambridge Lease Agreement").
+Added: The Cambridge Lease Agreement is for a period of three years commencing on September 15, 2023 and ending September 14, 2026.
+Added: According to the terms of the Cambridge Lease Agreement, the Company paid a less than $ 0.1 million security deposit and is required to pay monthly rent and common area charges.
+Added: 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, at inception of the lease.
+Added: The following table summarizes total lease expense during the years ended December 31, 2025 and 2024 (in thousands):
+Added: Years Ended December 31,
+Added: Straight-line operating lease expense
+Added: Variable lease expense
+Added: Total operating lease expense
+Added: The following table summarizes supplemental cash flow information during the years ended December 31, 2025 and 2024 (in thousands):
+Added: Years Ended December 31,
+Added: Cash paid for amounts included measurement of lease liabilities:
+Added: Operating cash flows from operating leases
+Added: Supplemental noncash information on lease liability arising from obtaining a right-use-asset
+Added: The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of December 31, 2025 (in thousands):
+Added: Years Ending December 31
+Added: Total future minimum lease payments
+Added: Total lease liabilities at present value
+Added: Lease liabilities, current
+Added: Lease liabilities, non-current
+Added: The following table summarizes lease term and discount rate as of December 31, 2025 and 2024:
+Added: Weighted-average remaining lease term (years)
+Added: Weighted-average discount rate
+Added: Commitments and Contingencies
+Added: Agreements with Novartis
+Added: 2024 Clinical Trial Collaboration and Supply Agreement with Novartis
+Added: On November 29, 2024, the Company entered into a Clinical Trial Collaboration and Supply Agreement (the "2024 Novartis Agreement") with Novartis Pharma AG (collectively, with affiliated entities, "Novartis").
+Added: Pursuant to the 2024 Novartis Agreement, Novartis will provide the Company with ribociclib drug supply for the Company’s Phase 3 OPERA-02 clinical trial of palazestrant in combination with ribociclib in ER+/HER2- frontline advanced or metastatic breast cancer (the "OPERA-02 trial").
+Added: Under the 2024 Novartis Agreement, the Company will supply (including manufacturing, packaging and labeling) palazestrant and letrozole for the OPERA-02 trial.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Except as otherwise specified below, the 2024 Novartis 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.
+Added: The parties retain their independent rights to commercialize their respective therapies both alone and with third parties.
+Added: 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").
+Added: 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.
+Added: 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 .
+Added: 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.
+Added: 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 2024 Novartis 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Notwithstanding the foregoing, if the 2024 Novartis 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.
+Added: 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 2024 Novartis Agreement as of immediately prior to the Repayment Trigger Event as compared to the total number of units that could be supplied under the 2024 Novartis Agreement.
+Added: The foregoing rights of first negotiation, first offer and notice and repayment obligations remain in effect until the first to occur of:
+Added: (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 2024 Novartis Agreement, and (c) such time as the 2024 Novartis Agreement is terminated by the Company due to Novartis’ material breach.
+Added: However, in the event the 2024 Novartis 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.
+Added: The 2024 Novartis Agreement will terminate on the fifth anniversary of the date on which the first dose of palazestrant is administered to the first study subject.
+Added: Either party may terminate the 2024 Novartis 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).
+Added: In addition, Novartis may terminate the 2024 Novartis 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 2024 Novartis 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.
+Added: Costs incurred in connection with the 2024 Novartis Agreement are included in the research and development expense in the accompanying consolidated statements of operations and comprehensive loss for the years ended December 31, 2025 and 2024.
+Added: 2020 Clinical Collaboration and Supply Agreement with Novartis
+Added: On July 22, 2020, the Company entered into a non-exclusive clinical collaboration and supply agreement with Novartis Institutes for BioMedical Research, Inc.
+Added: ("Novartis").
+Added: 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.
+Added: 1 (the "Novartis Amendment") to the amended and restated clinical collaboration and supply agreement (as amended, the "2020 Novartis Agreement").
+Added: 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 study of palazestrant in patients with metastatic estrogen receptor-positive breast cancer.
+Added: The Novartis Amendment, among other things, expanded the Company's clinical collaboration with Novartis, increasing the size of the ongoing Phase 1/2 study testing palazestrant in combination with ribociclib to approximately 60 patients.
+Added: The Company will be responsible for the conduct of the clinical trials for the combined therapies in accordance with a mutually agreed development plan.
+Added: As part of the collaboration, 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.
+Added: All inventions and data developed in the performance of the clinical trials for the combined therapies (other than those specific to each component study drug), will be jointly owned by the parties.
+Added: 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 the Novartis Study Drugs).
+Added: Novartis is responsible for manufacturing and delivering to the Company the Novartis Study Drugs in such quantities as reasonably needed for the clinical trials for the combined therapies.
+Added: In accordance with an agreed budget, subject to certain thresholds, Novartis will reimburse the Company for a majority of the direct outside costs that the Company incurs related to conducting the activities under the agreed development plan in conducting the clinical trials for the combined therapies.
+Added: The 2020 Novartis Agreement will terminate upon completion of all activities outlined in the development plan and the relevant protocols.
+Added: Either party may terminate the 2020 Novartis 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 Novartis Study Drugs or palazestrant.
+Added: In addition, Novartis may terminate the 2020 Novartis Agreement if certain disputes between the parties are not resolved after following the applicable dispute resolution procedures, and the Company may terminate the 2020 Novartis Agreement in the event the Company terminates all clinical trials of the combined therapies other than due to a material safety issue or upon a clinical hold.
+Added: Costs associated with research activities performed under the 2020 Novartis Agreement are included in research and development expenses in the accompanying consolidated statements of operations and comprehensive loss for the years ended December 31, 2025, and 2024, with any reimbursable costs from Novartis reflected as a reduction of such expenses.
+Added: The Company had previously incurred the full agreed-upon reimbursement amount.
+Added: Agreements with Pfizer
+Added: 2025 Clinical Trial Collaboration and Supply Agreement with Pfizer
+Added: In September 2025, the Company announced that it entered into a non-exclusive clinical trial collaboration and supply agreement with Pfizer Inc.
+Added: (“Pfizer”) (the “2025 Pfizer Agreement”), to evaluate the safety and tolerability of palazestrant in combination with Pfizer’s proprietary investigative selective CDK4 inhibitor atirmociclib in patients with metastatic ER+, HER2- breast cancer in a Phase 1b/2 clinical trial.
+Added: Under the terms of the 2025 Pfizer Agreement, the Company will be responsible for conducting the clinical trial for the combined therapies and Pfizer is responsible for supplying atirmociclib to the Company at no cost to the Company.
+Added: As part of the collaboration, the parties granted to each other a non-exclusive, royalty-free license under certain of the parties’ respective patent rights in the combination of atirmociclib and palazestrant to use the parties’ respective study drugs in research and development, solely to the extent reasonably needed for the other party’s activities in the collaboration.
+Added: All inventions and data developed in the performance of the clinical trials for the combined therapies (other than those specific to each component study drug), will be jointly owned by the parties.
+Added: 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.
+Added: Pfizer is responsible for manufacturing and delivering to us atirmociclib in such quantities as reasonably needed for the clinical trials for the combined therapies.
+Added: The 2025 Pfizer Agreement will terminate upon completion of all activities outlined in the study plan and the relevant protocols.
+Added: Either party may terminate the 2025 Pfizer Agreement for the uncured material breach of the other party, if it reasonably deems it necessary in order to protect the safety, health or welfare of subjects enrolled in the clinical trials for the combined therapies due to the existence of a material safety issue, or in certain circumstances for an unresolved clinical hold with respect to either atirmociclib or palazestrant.
+Added: In addition, Pfizer may terminate the 2025 Pfizer Agreement if reasonably and in good faith believe that atirmociclib is being used in an unsafe manner, and either party may terminate the 2025 Pfizer Agreement if either party determines to discontinue clinical development for medical, scientific, legal or other reasons.
+Added: The 2025 Pfizer Agreement does not grant any right of first negotiation to participate in future clinical trials, and each of the parties retains all rights and ability to evaluate their respective compounds.
+Added: Costs incurred in connection with the 2025 Pfizer Agreement are included in the research and development expense in the accompanying consolidated statements of operations and comprehensive loss for the year ended December 31, 2025.
+Added: 2020 Clinical Trial Agreement with Pfizer
+Added: In November 2020, the Company entered into a non-exclusive clinical trial agreement with Pfizer (the “Pfizer Agreement”), to evaluate the safety and tolerability of palazestrant in combination with Pfizer’s proprietary CDK4/6 inhibitor IBRANCE® (palbociclib) in patients with recurrent, locally advanced or metastatic ER+, HER2 breast cancer in a clinical trial.
+Added: Under the terms of the non-exclusive agreement, the Company will be responsible for conducting the clinical trial for the combined therapies and Pfizer is responsible for supplying IBRANCE® to the Company at no cost to the Company.
+Added: As part of the collaboration, the parties granted to each other a non-exclusive, royalty-free license under certain of the parties’ respective patent rights in the combination of IBRANCE® and palazestrant to use the parties’ respective study drugs in research and development, solely to the extent reasonably needed for the other party’s activities in the collaboration.
+Added: All inventions and data developed in the performance of the clinical trials for the combined therapies (other than those specific to each component study drug), will be jointly owned by the parties.
+Added: 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®).
+Added: Pfizer is responsible for manufacturing and delivering to us IBRANCE® in such quantities as reasonably needed for the clinical trials for the combined therapies.
+Added: The Pfizer Agreement will terminate upon completion of all activities outlined in the study plan and the relevant protocols.
+Added: Either party may terminate the Pfizer Agreement for the uncured material breach of the other party, if it reasonably deems it necessary in order to protect the safety, health or welfare of subjects enrolled in the clinical trials for the combined therapies due to the existence of a material safety issue, or in certain circumstances for an unresolved clinical hold with respect to either IBRANCE® or palazestrant.
+Added: 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.
+Added: 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.
+Added: Costs incurred in connection with the Pfizer Agreement are included in the research and development expense in the accompanying consolidated statements of operations and comprehensive loss for the years ended December 31, 2025, and 2024.
+Added: License Agreement with Aurigene
+Added: In June 2022, the Company entered into an exclusive global license agreement with Aurigene Discovery Technologies Limited (“Aurigene”) to research, develop and commercialize novel small molecule inhibitors of an undisclosed oncology target (the "Aurigene Agreement”).
+Added: Under the terms of the Aurigene Agreement, Aurigene will provide to the Company an exclusive license to its portfolio of novel small molecule inhibitors of the target.
+Added: Financial terms of the Aurigene Agreement include a $ 8.0 million upfront payment for rights to a pre-existing Aurigene program and potential future milestone payments of up to $ 60.0 million in clinical development and regulatory milestones, and up to $ 370.0 million in commercial milestones.
+Added: Aurigene is also eligible to receive mid-single digits to the low double digits royalties as percentages of product sales, if any.
+Added: During the research term, the Company will contribute funding to Aurigene to facilitate Aurigene’s ongoing discovery efforts.
+Added: The Company and Aurigene will jointly direct further preclinical work and, if successful, the Company will lead clinical development as well as regulatory and commercial activities.
+Added: The Company and Aurigene jointly own collaboration compounds and rights to any inventions made during the research term.
+Added: The term of the Aurigene Agreement will continue until the expiration of the last-to-expire of all payment obligations with respect to all licensed products thereunder, unless terminated earlier in accordance with the terms of the Aurigene Agreement.
+Added: 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.
+Added: The $ 8.0 million upfront payment was incurred in June 2022.
+Added: Costs incurred and milestones payments due to Aurigene prior to regulatory approval are recognized as research and development expenses in the period incurred.
+Added: 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.
+Added: 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 consolidated statement of operations and comprehensive loss during the year ended December 31, 2024.
+Added: The $ 10.0 million milestone payment related to dosing of the fifth patient in the first Phase 1 study was incurred and recognized as research and development expenses in the accompanying consolidated statement of operations and comprehensive loss during the year ended December 31, 2025.
+Added: Management Services Agreements
+Added: The Company conducts research and development programs internally and through third parties that include, among others, arrangements with vendors, consultants, CMOs, and CROs.
+Added: 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.
+Added: In addition, these agreements may, from time to time, be subjected to amendments as a result of any change orders executed by the parties.
+Added: As of December 31, 2025, the Company did not have material contractual commitments with respect to these arrangements.
+Added: Contingencies
+Added: From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business.
+Added: The Company accrues a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated.
+Added: For all periods presented, the Company was not a party to any pending material litigation or other material legal proceedings.
+Added: Indemnification Agreements
+Added: In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties.
+Added: In addition, the Company has entered into indemnification agreements with members of its Board and executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers.
+Added: The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited.
+Added: As of December 31, 2025, the Company had not incurred any material costs as a result of such indemnifications.
+Added: Long-term Borrowing
+Added: On September 5, 2023, the Company entered into the Original Loan Agreement by and between the Company and the Bank .
+Added: 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 and the issuance of our common stock to selected institutional and accredited investors pursuant to a securities purchase agreement in September 2023 ("Term Loan A"), and the remaining $ 25.0 million could have been made available upon approval of the Bank in its discretion.
+Added: The Original Credit Facility was scheduled to mature on August 1, 2027 (the "Original Maturity Date").
+Added: On June 28, 2024, the Company entered into the First Amendment, which, among other things, (i) increased the aggregate principal amount of the Original Credit Facility from up to $ 50.0 million to up to $ 100.0 million (the "Credit Facility"), of which the Term Loan A of $ 25.0 million was immediately available, an additional $ 25.0 million will become available upon the Company achieving certain milestones related to the 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 the approval of the Bank in its discretion, and (ii) extended the Original Maturity Date to July 1, 2028 .
+Added: On June 27, 2025, the Company entered into the Second Amendment, which, among other things, (i) decreased the interest rate to a floating rate equal to the greater of 6.0 % or the prime rate, and (ii) extended the draw period of the Term Loan A to January 15, 2026 .
+Added: On January 11, 2026, the Company entered into the Third Amendment, which among other things, (i) extended the draw period of Term Loan A to January 31, 2027 , (ii) extended the draw period of Term Loan B to January 31, 2027 , (iii) extended the draw period of Term Loan C to January 31, 2027 , and (iv) extended the maturity date to January 1, 2029 ("Maturity Date").
+Added: Based on the occurrence of specified (a) development milestones related to the pivotal Phase 3 OPERA-01 clinical trial of palazestrant or (b) receipt of proceeds from capital financing, the draw period of Term Loan B and Term Loan C may be further extended to July 31, 2027, and the Maturity Date may be further extended to July 1, 2029.
+Added: The obligations under the Loan Agreement are secured by substantially all of the assets of the Company, subject to limited exceptions.
+Added: During the term of the Credit Facility, interest will accrue on any outstanding balance due under the Credit Facility at a floating rate per annum equal to the greater of (i) 6.0 % and (ii) the prime rate.
+Added: During an event of default, any outstanding amount under the Credit Facility will bear interest at a rate of 3.0 % in excess of the otherwise applicable rate of interest.
+Added: The Company will pay certain fees with respect to the Credit Facility, including a prepayment fee on any amount advanced under the Credit Facility to the extent paid prior to the Maturity Date, a final payment fee on the amount advanced under the Credit Facility.
+Added: The Loan Agreement contains customary events of default, including, but not limited to, nonpayment of principal, interest, fees or other amounts;
+Added: material inaccuracy of a representation or warranty;
+Added: failure to perform or observe covenants;
+Added: cross-defaults with certain other indebtedness;
+Added: bankruptcy and insolvency events;
+Added: material monetary judgment defaults;
+Added: material adverse change occurs;
+Added: and a material impairment in the Bank’s security interest.
+Added: Upon the occurrence of an event of default (subject, in certain cases, to notice and grace periods), obligations under the Loan Agreement may be accelerated.
+Added: The Loan Agreement also contains a number of customary representations, warranties and covenants that, among other things, limit the ability of the Company to (subject to certain qualifications and exceptions):
+Added: create liens and encumbrances;
+Added: incur additional indebtedness;
+Added: merge, dissolve, liquidate or consolidate;
+Added: make acquisitions, investments, advances or loans;
+Added: dispose of or transfer assets;
+Added: pay dividends or make other payments in respect of its capital stock;
+Added: amend certain material documents;
+Added: redeem or repurchase certain debt;
+Added: make payments on subordinated debt;
+Added: and engage in certain transactions with affiliates.
+Added: As of December 31, 2025, the Company had drawn $ 3.0 million from the Credit Facility which was recorded at cost and presented as long-term borrow ing on the consolidated balance sheet.
+Added: The interest expense was $ 0.1 million for the year ended December 31, 2025, which was included in other income on the consolidated statement of operations and comprehensive loss.
+Added: As of December 31, 2025, the carrying amount of the borrowing approximated fair value, as the interest rate is variable and resets periodically based on market rates.
+Added: Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
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.