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Olema Pharmaceuticals(OLMA) - 2022 Q2 - Quarterly Report
2022-08-09 21:14
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].
Olema Pharmaceuticals(OLMA) - 2022 Q1 - Quarterly Report
2022-05-09 20:44
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]
Olema Pharmaceuticals (OLMA) Investor Presentation - Slideshow
2022-04-14 17:57
1 Improving the lives of women with breast cancer April 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 ...
Olema Pharmaceuticals (OLMA) Investor Presentation - Slideshow
2022-03-25 18:02
1 Improving the lives of women with breast cancer March 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 ...
Olema Pharmaceuticals(OLMA) - 2021 Q4 - Annual Report
2022-02-28 21:56
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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) (State or other jurisdiction of inco ...
Olema Pharmaceuticals(OLMA) - 2021 Q3 - Quarterly Report
2021-11-10 21:21
Financial Position - As of September 30, 2021, the company had cash, cash equivalents, and marketable securities totaling $306.0 million, expected to fund operations through the end of 2023[107]. - As of September 30, 2021, the company had $306.0 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $82.6 million[142]. - The company anticipates that its existing cash and marketable securities will fund operations through the end of 2023, after which substantial additional funding will be required[146]. Operating Losses - The company reported net losses of $17.7 million for Q3 2021, compared to $7.8 million for Q3 2020, and cumulative losses of $49.5 million for the nine months ended September 30, 2021, versus $12.0 million for the same period in 2020[108]. - The company expects to continue incurring significant operating losses and increasing research and development expenses as it advances its lead product candidate OP-1250 and explores additional product candidates[109]. - The net loss for the nine months ended September 30, 2021, was $49.5 million, compared to a net loss of $12.0 million for the same period in 2020, representing an increase of $37.5 million[140]. Research and Development Expenses - Research and development expenses for Q3 2021 were $12.5 million, up from $4.7 million in Q3 2020, and $35.1 million for the nine months ended September 30, 2021, compared to $7.4 million for the same period in 2020[122]. - Research and development expenses for Q3 2021 were $12.5 million, an increase of $7.8 million from $4.7 million in Q3 2020, primarily due to advancing the clinical study of OP-1250 and increased personnel costs[133]. - Research and development expenses for the nine months ended September 30, 2021, included $5.9 million in non-cash stock-based compensation[137]. Revenue Generation - The company has not generated any revenue from product sales and does not anticipate doing so in the foreseeable future[118]. - The company has not generated any revenue from product sales and does not expect to do so until regulatory approval and commercialization of its product candidates[145]. Clinical Trials and Product Development - The ongoing Phase 1/2 clinical trial for OP-1250 was initiated in August 2020, with initial data expected in Q4 2021[104]. - The company is focused on developing OP-1250 as a potential endocrine therapy for ER+ breast cancers, addressing limitations of current therapies[104]. - The company plans to scale up external manufacturing capacity to meet clinical trial and potential commercialization needs[109]. - The company relies on third parties for manufacturing and does not own or operate any manufacturing facilities[106]. General and Administrative Expenses - General and administrative expenses for Q3 2021 were $5.2 million, up $2.0 million from $3.2 million in Q3 2020, driven by increased headcount and external consultant expenses[134]. - Total operating expenses for the nine months ended September 30, 2021, were $49.7 million, compared to $11.4 million for the same period in 2020, reflecting a $38.3 million increase[136]. Cash Flow Activities - Net cash used in operating activities for the nine months ended September 30, 2021, was $32.1 million, compared to $10.9 million for the same period in 2020[152]. - Net cash used in operating activities for the nine months ended September 30, 2020, was $12.0 million, with a net loss primarily from $7.4 million in research and development expenses and $4.0 million in general and administrative expenses[156]. - Net cash used in investing activities for the nine months ended September 30, 2021, was primarily due to purchases of marketable securities financed through IPO proceeds and convertible preferred stock sales[157]. - Net cash provided by financing activities for the nine months ended September 30, 2021, included $0.4 million from the sale of common stock under the 2020 ESPP and $0.2 million from the exercise of stock options[158]. - Net cash provided by financing activities during the nine months ended September 30, 2020, included $50.6 million from Series B convertible preferred stock and $87.4 million from Series C convertible preferred stock[159]. Other Financial Information - There were no significant changes to contractual obligations and commitments during the nine months ended September 30, 2021[160]. - The company did not have any off-balance sheet arrangements during the periods presented[161]. - There were no material changes to critical accounting policies during the nine months ended September 30, 2021[163]. - Market risk disclosures remained unchanged during the nine months ended September 30, 2021[164].
Olema Pharmaceuticals(OLMA) - 2021 Q2 - Quarterly Report
2021-08-10 20:18
Financial Position - As of June 30, 2021, the company had cash, cash equivalents, and marketable securities totaling $318.1 million, expected to fund operations through the end of 2023[109]. - As of June 30, 2021, the company had $318.1 million in cash, cash equivalents, and marketable securities[144]. - The company anticipates that its existing cash and marketable securities will fund operations through the end of 2023, after which substantial additional funding will be needed[148]. Losses and Expenses - The company reported net losses of $16.4 million for Q2 2021, compared to $2.5 million for Q2 2020, and an accumulated deficit of $64.8 million as of June 30, 2021[110]. - Net loss for the six months ended June 30, 2021 was $31.7 million, compared to a net loss of $4.1 million for the same period in 2020[142]. - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances the nonclinical and clinical development of its lead product candidate OP-1250[145]. - General and administrative expenses for the three months ended June 30, 2021 were $4.6 million, up $4.1 million from $0.5 million in the same period in 2020[136]. - Total operating expenses for the six months ended June 30, 2021 were $31.97 million, an increase of $28.44 million compared to the same period in 2020[138]. - Net cash used in operating activities for the six months ended June 30, 2021 was $19.99 million, compared to $3.32 million for the same period in 2020[154]. Research and Development - Research and development expenses for Q2 2021 were $11.9 million, significantly up from $1.9 million in Q2 2020, and totaled $22.6 million for the first half of 2021 compared to $2.7 million in the same period of 2020[124]. - The increase in research and development expenses for the six months ended June 30, 2021 was primarily due to advancing the OP-1250 clinical study and associated costs[139]. - The company anticipates significant increases in research and development expenses as it advances OP-1250 and other potential product candidates through clinical trials[111]. - The ongoing Phase 1/2 trial for OP-1250, targeting ER+ breast cancer, was initiated in August 2020, with initial data expected in Q4 2021[105]. - The company aims to expand its clinical product pipeline and may pursue additional product candidates in the future[111]. Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so for the foreseeable future[120]. - The company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained for its product candidates[147]. Funding and Financing - The company expects to incur substantial additional funding needs to support product development and operations, potentially through equity or debt financing[114]. - Net cash provided by financing activities for the six months ended June 30, 2021 included $0.4 million from the sale of common stock under the 2020 ESPP and $0.1 million from stock options exercise[161]. - Net cash provided by financing activities for the six months ended June 30, 2020 was $50.7 million from the sale and issuance of Series B convertible preferred stock and $3.0 million from convertible promissory notes[162]. Operational Challenges - The COVID-19 pandemic has caused delays in clinical trial setup and site initiation, impacting recruitment and timelines[115]. - The company relies on third parties for manufacturing and does not plan to establish its own manufacturing facilities[108]. Other Financial Information - Net cash used in investing activities for the six months ended June 30, 2021 was mainly for purchases of marketable securities, financed through IPO proceeds and convertible preferred stock sales[160]. - There were no significant changes to contractual obligations and commitments during the six months ended June 30, 2021[163]. - The company did not have any off-balance sheet arrangements during the periods presented[164]. - There were no material changes to critical accounting policies during the six months ended June 30, 2021[166]. - No material changes to market risk disclosures were reported for the six months ended June 30, 2021[167].
Olema Pharmaceuticals(OLMA) - 2021 Q1 - Quarterly Report
2021-05-11 20:22
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 transition period from _______ to _______ Commission File Number: 001-39712 OLEMA PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delawa ...
Olema Pharmaceuticals (OLMA) Investor Presentation - Slideshow
2021-04-16 18:59
1 Improving the lives of people with breast cancer April 2021 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 ...
Olema Pharmaceuticals(OLMA) - 2020 Q4 - Annual Report
2021-03-17 20:21
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K For the fiscal year ended December 31, 2020 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) Delaware 30-0409740 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (State or other ...