[Olema Pharmaceuticals, Inc. Form 8-K Current Report](index=1&type=section&id=Olema%20Pharmaceuticals%2C%20Inc.%20Form%208-K%20Current%20Report) [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Olema Pharmaceuticals, Inc. announced its fiscal year 2023 financial results on March 11, 2024, furnished via Exhibit 99.1 - The company reported its financial results for the year ended December 31, 2023, via a press release[6](index=6&type=chunk) - The press release with financial results is attached as Exhibit 99.1 and incorporated by reference[6](index=6&type=chunk) - Information in this section and Exhibit 99.1 is furnished, not filed, limiting legal liabilities under Section 18 of the Securities Exchange Act of 1934[7](index=7&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section details the exhibits accompanying the Form 8-K, including the financial results press release and interactive data file List of Exhibits | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release, dated March 11, 2024, of Olema Pharmaceuticals, Inc. | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | [Signatures](index=4&type=section&id=Signatures) The report was duly authorized and signed by Shane Kovacs, Chief Operating and Financial Officer, on March 11, 2024 - The report was signed on behalf of the registrant by Shane Kovacs, Chief Operating and Financial Officer[11](index=11&type=chunk)[13](index=13&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-39712 OLEMA PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) De ...

Financial Position - As of June 30, 2023, the company had cash, cash equivalents, and marketable securities totaling $167.4 million, expected to fund operations into the second quarter of 2025[108]. - As of June 30, 2023, the company had $167.4 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $257.4 million[144]. - The company anticipates cash reserves will fund operations into the second quarter of 2025, with a projected balance of $120.0 to $125.0 million by the end of 2023[148]. - The company experienced a net increase in cash and cash equivalents of $11.3 million for the six months ended June 30, 2023, compared to $10.7 million in the same period of 2022[152]. Losses and Expenses - The company reported net losses of $20.1 million for Q2 2023, compared to $32.9 million for Q2 2022, and cumulative losses of $257.4 million as of June 30, 2023[109]. - The company expects to incur significant and increasing losses as it advances its product candidate and continues operations as a public company[110]. - The net loss for the six months ended June 30, 2023 was $48.4 million, which included $40.8 million in research and development expenses and $10.4 million in general and administrative expenses[153]. - The company expects to incur significant expenses and operating losses as it advances clinical development, necessitating additional capital through equity or debt financing[145]. Research and Development - Research and development expenses for Q2 2023 were $18.0 million, down from $27.1 million in Q2 2022, and totaled $40.8 million for the first half of 2023, compared to $43.1 million for the same period in 2022[122]. - Research and development expenses for Q2 2023 were $18.0 million, a decrease of $9.1 million from $27.1 million in Q2 2022, primarily due to reduced spending on preclinical research and clinical pharmacology-related costs[136]. - For the six months ended June 30, 2023, research and development expenses totaled $40.8 million, down from $43.1 million in the same period of 2022, a decrease of $2.2 million[140]. - The company plans to present Phase 2 clinical data for its lead product candidate, palazestrant, at the European Society for Medical Oncology Congress 2023 in October 2023[101]. - The company initiated a Phase 3 clinical trial for palazestrant in advanced or metastatic breast cancer, expected to start in Q4 2023[101]. - The company anticipates presenting updated results from combination studies of palazestrant with CDK4/6 inhibitors in Q4 2023[104]. - The company was granted Fast Track designation by the FDA for palazestrant for patients with ER+/HER2- metastatic breast cancer[105]. Operating Expenses - General and administrative expenses for Q2 2023 were $3.6 million, down from $6.2 million in Q2 2022, reflecting lower corporate and legal-related costs and reduced personnel expenses[137]. - Total operating expenses for Q2 2023 were $21.6 million, a reduction of $11.7 million compared to $33.3 million in Q2 2022[135]. - General and administrative expenses for the six months ended June 30, 2023 were $10.4 million, compared to $13.5 million in the same period of 2022, a decrease of $3.1 million[141]. Cash Flow - Net cash used in operating activities for the six months ended June 30, 2023 was $42.5 million, a slight improvement from $44.4 million in the same period of 2022[152]. - Net cash provided by investing activities for the six months ended June 30, 2023 was $51.5 million, compared to $55.0 million in the same period of 2022[152]. - Net cash provided by financing activities during the six months ended June 30, 2023 was $2.3 million, significantly higher than $0.1 million in the same period of 2022[156]. Accounting and Market Risk - There were no material changes to critical accounting policies and estimates during the six months ended June 30, 2023[159]. - The company has not reported any material changes to market risk disclosures during the six months ended June 30, 2023[160].

FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents For the quarterly period ended March 31, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-39712 OLEMA PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delawa ...

Financial Position - As of December 31, 2022, the company had cash, cash equivalents, and marketable securities totaling $204.4 million, expected to fund operations into 2025[647]. - The company reported net losses of $104.8 million and $71.1 million for the years ended December 31, 2022, and 2021, respectively, with an accumulated deficit of $209.0 million as of December 31, 2022[648]. - Cash, cash equivalents, and marketable securities as of December 31, 2022, totaled $204.4 million, down from $287.3 million in 2021[707]. - The company has no debt outstanding as of December 31, 2022, and has raised aggregate gross proceeds of $393.2 million from various financing activities[678]. - The company qualifies as a "smaller reporting company" due to annual revenue being less than $100.0 million in 2022[705]. - Total current assets decreased from $290.7 million in 2021 to $208.9 million in 2022, a decline of approximately 28.2%[724]. - Total assets decreased from $295.9 million in 2021 to $215.6 million in 2022, a decline of approximately 27.1%[724]. - The company had a total of $4.5 million in prepaid expenses and other current assets as of December 31, 2022, an increase from $3.4 million in 2021[778]. - The total fair value of financial assets as of December 31, 2022, was $204.5 million, consisting of $100.8 million in Level 1 inputs and $103.7 million in Level 2 inputs[772]. Research and Development - Research and development expenses for the lead product candidate OP-1250 were $82.3 million in 2022, up from $51.1 million in 2021, indicating a significant increase in investment[664]. - The company has not generated any revenue from product sales and does not expect to do so for the foreseeable future[658]. - The company anticipates presenting Phase 2 clinical data for OP-1250 as a monotherapy in the second half of 2023[643]. - The company initiated Phase 1b/2 studies for OP-1250 in combination with CDK4/6 inhibitors and reported initial data in December 2022[643]. - The ongoing COVID-19 pandemic has caused delays in clinical study setups and site initiations, impacting development timelines[653]. - Research and development expenses for the year ended December 31, 2022, were $82.3 million, an increase of $31.2 million from $51.1 million in 2021, primarily due to advancing the clinical study for OP-1250 and associated costs[675]. - The company expects to incur significant and increasing losses as it advances its product candidate and expands its clinical pipeline[649]. - The company is focused on developing OP-1250, a novel oral therapy for breast cancer, currently in Phase 1/2 clinical studies[734]. - The company experienced delays in clinical trial enrollment due to the COVID-19 pandemic, impacting development timelines[739]. Operating Expenses - General and administrative expenses for the year ended December 31, 2022, were $24.7 million, up $4.3 million from $20.4 million in 2021, mainly due to higher personnel-related expenses and public company-related costs[676]. - Total operating expenses increased from $71.5 million in 2021 to $107.0 million in 2022, an increase of approximately 49.5%[725]. - The net loss for the year ended December 31, 2022, was $104.8 million, compared to a net loss of $71.1 million in 2021, reflecting an increase of $33.7 million[674]. - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances the clinical development of OP-1250 and other programs[681]. - Net cash used in operating activities for the year ended December 31, 2022, was $82.1 million, compared to $50.7 million in 2021[693]. - Net cash used in operating activities for the year ended December 31, 2022, was $104.8 million, with $82.3 million in research and development expenses and $24.7 million in general and administrative expenses[694]. Stock-Based Compensation - Stock-based compensation is recognized as an expense on a straight-line basis over the requisite service period, with performance-based awards assessed quarterly[765]. - The stock-based compensation expense for the year ended December 31, 2022 was $18.8 million, an increase from $15.9 million in 2021[801]. - The total unrecognized compensation expense related to unvested options was $34.7 million, expected to be recognized over an estimated weighted average period of 2.54 years[791]. - The total fair value of options vested during the years ended December 31, 2022 and 2021 was $11.3 million and $10.9 million, respectively[790]. - The stock-based compensation expense related to the 2020 Employee Stock Purchase Plan (ESPP) was $0.4 million for the year ended December 31, 2022, compared to $0.2 million in 2021[800]. Future Obligations and Agreements - Future cash requirements include potential milestone payments of up to $60.0 million in clinical development and regulatory milestones, and up to $370.0 million in commercial milestones under the Aurigene Agreement[686]. - The Company entered into an exclusive global license agreement with Aurigene, involving an upfront payment of $8.0 million and potential milestone payments of up to $430.0 million[824]. - The Company recorded zero expense related to milestone targets under the Aurigene Agreement for the year ended December 31, 2022, as it was not probable to achieve any milestones[828]. - The Company is responsible for manufacturing OP-1250 and conducting clinical trials under the Novartis Agreement, which focuses on metastatic breast cancer[815]. Workforce and Operational Changes - The Company plans to reduce its workforce by approximately 25%, resulting in a one-time accounting charge of approximately $2.8 million in the first quarter of 2023[832]. - The Company entered into a lease agreement for approximately 3,500 square feet of office space in San Francisco, with a total lease liability of $0.3 million recorded in the financial statements[811]. - Total future minimum lease payments as of December 31, 2022, amount to $2.875 million, with current lease liabilities of $1.015 million[813]. - Total operating lease expense for the year ended December 31, 2022, was $1.598 million, an increase of 14.14% from $1.400 million in 2021[813]. - The weighted-average remaining lease term decreased from 3.63 years in 2021 to 2.73 years in 2022[814]. Tax and Deferred Assets - The Company has recorded full valuation allowance against its net deferred tax assets as of December 31, 2022, and 2021[761]. - The valuation allowance for deferred tax assets increased to $47.4 million as of December 31, 2022, from $21.1 million in 2021[803]. - The Company had Federal net operating losses (NOLs) of approximately $115.0 million as of December 31, 2022, up from $81.8 million in 2021[804]. Market and Economic Conditions - The Company continues to face macroeconomic uncertainties, including labor shortages, inflation, and recession risks, which may impact its operational and financial performance[740]. - Inflation has not had a material effect on the company's results of operations during the periods presented[710]. - The Company has not had any significant foreign currency transactions and does not have a formal hedging program[709]. - The Company is subject to foreign currency risk, particularly with contracts denominated in Australian dollars and Euros, impacting its financial results[767].

Financial Performance - The company reported net losses of $22.7 million for Q3 2022, compared to $17.7 million for Q3 2021, and $78.6 million for the nine months ended September 30, 2022, compared to $49.5 million for the same period in 2021[117]. - The net loss for Q3 2022 was $22.7 million, compared to a net loss of $17.7 million in Q3 2021, reflecting an increase of 28.4%[150]. - The net loss for the nine months ended September 30, 2022 included $19.1 million in general and administrative expenses, compared to $14.6 million in 2021, reflecting increased operational costs[162][163]. - The company has not generated any revenue from product sales and expects to continue incurring significant operating losses[150]. Research and Development - Research and development expenses for Q3 2022 were $17.6 million, up from $12.5 million in Q3 2021, and $60.7 million for the nine months ended September 30, 2022, compared to $35.1 million for the same period in 2021[134]. - Research and development expenses for the nine months ended September 30, 2022, were $60.7 million, up from $35.1 million in 2021, indicating a significant investment in product development[162][163]. - The lead product candidate, OP-1250, is in ongoing Phase 1/2 trials for ER+/HER2- breast cancer, with plans to initiate a pivotal Phase 3 study in mid-2023[112]. - The company anticipates significant increases in research and development and general administrative costs as it advances its product candidates and expands its operations[152]. - The company has been granted Fast Track designation from the FDA for OP-1250 for ER+/HER2- metastatic breast cancer[113]. Cash and Liquidity - As of September 30, 2022, the company had cash, cash equivalents, and marketable securities totaling $222.6 million, expected to fund operations into the second half of 2024[116]. - The company incurred an accumulated deficit of $182.8 million as of September 30, 2022[117]. - The company anticipates needing additional capital to fund operations, which may come from equity or debt financings, collaborations, or licensing arrangements[152]. - Net cash used in operating activities for the nine months ended September 30, 2022 was $62.354 million, compared to $32.087 million in the same period of 2021, reflecting an increase in net loss from $49.5 million to $78.6 million[162][163]. - The company reported a net increase in cash and cash equivalents of $12.992 million for the nine months ended September 30, 2022, contrasting with a decrease of $312.952 million in the same period of 2021[161]. Operating Expenses - General and administrative expenses for Q3 2022 were $5.6 million, compared to $5.2 million in Q3 2021, an increase of 6.8%[144]. - Total operating expenses for the nine months ended September 30, 2022, were $79.8 million, a 60.4% increase from $49.7 million in the same period of 2021[146]. - Non-cash charges for the nine months ended September 30, 2022 included $14.0 million in stock-based compensation, compared to $11.3 million in 2021, indicating a rise in employee compensation costs[162][163]. Operational Challenges - The ongoing COVID-19 pandemic has caused delays in clinical trial setups and recruitment, impacting operational timelines[122]. - The company relies on third parties for manufacturing and does not plan to establish its own manufacturing facilities[115].

| --- | --- | --- | |----------------------------------|-------|-------| | | | | | | | | | Phase 1/2 Study Update ENA 2022 | | | | October 26, 2022 | | | 1 Forward-Looking Statements 2 This presentation contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, stat ...

1 Improving the lives of women with breast cancer August 2022 Forward-Looking Statements 2 This presentation contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding our research and clinical development plans, the scope, progress, results and ...

Financial Position - As of June 30, 2022, the company had cash, cash equivalents, and marketable securities totaling $240.7 million, expected to fund operations into the second half of 2024[106]. - The accumulated deficit as of June 30, 2022, was $160.1 million, with no debt outstanding[139]. - The company anticipates needing additional capital to fund operations, which may come from equity or debt financings, collaborations, or licensing arrangements[142]. Financial Performance - The company reported net losses of $32.9 million for Q2 2022, compared to $16.4 million for Q2 2021, and $55.9 million for the first half of 2022, compared to $31.7 million for the same period in 2021[107]. - The net loss for Q2 2022 was $32.9 million, compared to a net loss of $16.4 million in Q2 2021, reflecting an increase of 100%[138]. - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances the development of OP-1250[140]. Research and Development - Research and development expenses for Q2 2022 were $27.1 million, up from $11.9 million in Q2 2021, and $43.1 million for the first half of 2022, compared to $22.6 million for the same period in 2021[121]. - Research and development expenses for the first half of 2022 were $43.1 million, up from $22.6 million in the first half of 2021, an increase of 91%[135]. - The ongoing Phase 1/2 trial for the lead product candidate OP-1250 is evaluating its efficacy in treating ER+/HER2- breast cancer, with initial data expected in Q4 2022[101]. Operating Expenses - General and administrative expenses for Q2 2022 were $6.2 million, compared to $4.6 million in Q2 2021, an increase of 35%[131]. - General and administrative expenses for the first half of 2022 were $13.5 million, compared to $9.4 million in the first half of 2021, an increase of 44%[136]. - Total operating expenses for Q2 2022 were $33.3 million, a 101% increase from $16.5 million in Q2 2021[129]. Cash Flow - Net cash used in operating activities for the six months ended June 30, 2022 was $55.9 million, with a net loss primarily due to $43.1 million in research and development expenses and $13.5 million in general and administrative expenses[151]. - For the six months ended June 30, 2021, net cash used in operating activities was $31.7 million, with $22.6 million in research and development expenses and $9.4 million in general and administrative expenses[152]. - Net cash provided by financing activities during the six months ended June 30, 2022 was $0.1 million from the sale of common stock under the 2020 ESPP and exercise of stock options[157]. Manufacturing and Operations - The company plans to scale up external manufacturing capacity and establish a sales and marketing infrastructure for potential commercialization[113]. - The company relies on third parties for manufacturing and does not plan to establish its own manufacturing facilities[105]. - The COVID-19 pandemic has caused delays in clinical trial setup and recruitment, impacting development timelines[112]. Accounting and Risk - There were no material changes to critical accounting policies and estimates during the six months ended June 30, 2022[159]. - The company’s management evaluates estimates and assumptions on an ongoing basis, which may differ from actual results under different conditions[158]. - No material changes to market risk disclosures were reported for the six months ended June 30, 2022[160].

Financial Position - As of March 31, 2022, the company had cash, cash equivalents, and marketable securities totaling $267.9 million, expected to fund operations into 2024[102] - The accumulated deficit as of March 31, 2022, was $127.2 million, with no debt outstanding[132] Operating Losses - The company reported net losses of $23.0 million for the three months ended March 31, 2022, compared to $15.3 million for the same period in 2021, with an accumulated deficit of $127.2 million[103] - The company expects to incur significant operating losses for the foreseeable future as it advances its product candidates[104] - The net loss for Q1 2022 was $23.0 million, compared to a net loss of $15.3 million in Q1 2021, indicating an increase in losses of 50.5%[127] Research and Development Expenses - Research and development expenses for the lead product candidate OP-1250 were $16.0 million for the three months ended March 31, 2022, up from $10.7 million in the same period of 2021[119] - Research and development expenses for Q1 2022 were $16.0 million, up from $10.7 million in Q1 2021, representing a 49.7% increase[128] - The increase in research and development expenses was primarily due to advancing the clinical study for OP-1250 and associated contract manufacturing costs[128] - The company expects significant increases in both research and development and general and administrative expenses as it advances its product candidates and expands operations[133] Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so for the foreseeable future[113] - The company has not generated any revenue from product sales to date and does not expect to do so until regulatory approval is obtained[135] Funding Requirements - The company anticipates requiring substantial additional funding to support ongoing operations and product development[107] - The company anticipates needing additional capital to fund ongoing operations and development efforts, with future funding requirements dependent on various factors including clinical trial outcomes[135] Cash Flow - Net cash used in operating activities for Q1 2022 was $17.9 million, compared to $11.1 million in Q1 2021, marking a 61.5% increase[142] - Net cash provided by financing activities for the three months ended March 31, 2022, was less than $0.1 million from the exercise of stock options[146] - There were no financing activities during the three months ended March 31, 2021[147] Clinical Trials - The ongoing Phase 1/2 trial for OP-1250 is evaluating its effectiveness in treating ER+/HER2- breast cancer, with initial data reported in November 2021[97] - The company is actively monitoring the impact of the COVID-19 pandemic on its operations and clinical trials[108] Manufacturing and Operations - The company relies on third parties for manufacturing and does not own any manufacturing facilities[101] Commitments and Contingencies - No significant changes to commitments and contingencies were reported during the three months ended March 31, 2022[148] - There are currently no off-balance sheet arrangements as defined by SEC regulations[149] Accounting Policies - No material changes to critical accounting policies were reported for the three months ended March 31, 2022[151] - There were no material changes to market risk disclosures during the three months ended March 31, 2022[152]