Olema Pharmaceuticals Files 2023 Annual Report on Form 10-K

TL;DR

<b>Olema Pharmaceuticals filed its 2023 10-K report detailing its fiscal year performance and corporate structure.</b>

AI Summary

Olema Pharmaceuticals, Inc. (OLMA) filed a Annual Report (10-K) with the SEC on March 11, 2024. Olema Pharmaceuticals, Inc. filed its 2023 Annual Report on Form 10-K on March 11, 2024. The filing covers the fiscal year ending December 31, 2023. Key entities mentioned include Olema Pharmaceuticals, Inc., Novartis Agreement, and BioMedicalResearch Inc. The company's business address is 780 Brannan Street, San Francisco, CA. The filing details various stock plans including the 2020 Equity Incentive Plan and 2014 Stock Plan.

Why It Matters

For investors and stakeholders tracking Olema Pharmaceuticals, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Olema Pharmaceuticals' financial health, operational activities, and strategic direction for the fiscal year 2023. Investors and stakeholders can use this report to assess the company's performance, understand its risk factors, and evaluate its executive compensation structure.

Risk Assessment

Risk Level: medium — Olema Pharmaceuticals, Inc. shows moderate risk based on this filing. The company is in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, lengthy development cycles, and substantial R&D investment, posing inherent risks to financial performance and market success.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to understand Olema Pharmaceuticals' current financial position and future outlook.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-11 — Filed As Of Date (Date the filing was submitted)
• 001-39712 — SEC File Number (SEC registration number)
• 2834 — SIC Code (Standard Industrial Classification for Pharmaceutical Preparations)

Key Players & Entities

• Olema Pharmaceuticals, Inc. (company) — Filer name
• 2024-03-11T00:00:00.000Z (date) — Filing date
• 20231231 (date) — Fiscal year end
• Novartis Agreement (company) — Mentioned entity
• BioMedicalResearch Inc (company) — Mentioned entity
• 780 BRANNAN STREET (address) — Business address
• SAN FRANCISCO (location) — Business address city
• DE (location) — State of incorporation

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — Covers the full fiscal year 2023 financial performance.
• 2024-03-11: Filing Date — Indicates when the 10-K was officially submitted to the SEC.

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (This is the primary document for understanding a company's financial health and operations over the past year.)

Equity Incentive Plan

A type of employee stock option plan that allows employees to purchase company stock at a predetermined price. (Relevant for understanding employee compensation and potential dilution.)

Performance Shares

Stock awards granted to employees that vest only if certain performance goals are met. (Indicates how executive compensation is tied to company performance.)

Key Financial Figures

• $0.0001 — h Registered Common Stock , par value $0.0001 per share OLMA The Nasdaq Global Se
• $22.3 b — he breast cancer therapy market totaled $22.3 billion, and it is set to grow at a CAGR
• $51.3 billion — set to grow at a CAGR of 8.7%, reaching $51.3 billion in 2030. All key breast cancer populati
• $11.3 billion — n the HR+/HER2- population to rise from $11.3 billion in 2020 to more than $30 billion by 203
• $30 billion — from $11.3 billion in 2020 to more than $30 billion by 2030. The ER is a nuclear receptor
• $1.1 billion — strant achieved worldwide sales of over $1.1 billion in 2019. More recently, the field has

Filing Documents

• olma-20231231.htm (10-K) — 2932KB
• olma-ex1_1.htm (EX-1.1) — 328KB
• olma-ex21_1.htm (EX-21.1) — 3KB
• olma-ex23_1.htm (EX-23.1) — 5KB
• olma-ex31_1.htm (EX-31.1) — 14KB
• olma-ex31_2.htm (EX-31.2) — 15KB
• olma-ex32_1.htm (EX-32.1) — 8KB
• olma-ex32_2.htm (EX-32.2) — 8KB
• olma-ex97_1.htm (EX-97.1) — 52KB
• img207288282_0.jpg (GRAPHIC) — 857KB
• img207288282_1.jpg (GRAPHIC) — 1793KB
• img207288282_2.jpg (GRAPHIC) — 729KB
• img207288282_3.jpg (GRAPHIC) — 609KB
• img207288282_4.jpg (GRAPHIC) — 1552KB
• img207288282_5.jpg (GRAPHIC) — 570KB
• img207288282_6.jpg (GRAPHIC) — 815KB
• 0000950170-24-029281.txt (&nbsp;) — 27366KB
• olma-20231231.xsd (EX-101.SCH) — 1126KB
• olma-20231231_htm.xml (XML) — 1782KB

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations. 111 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk. 123 Item 8. Consolidated Financial Statements and Supplementary Data. 124 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. 152 Item 9A.

Controls and Procedures

Controls and Procedures. 152 Item 9B. Other Information. 153 Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 153 PART III Item 10. Directors, Executive Officers and Corporate Governance. 154 Item 11.

Executive Compensation

Executive Compensation. 154 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. 154 Item 13. Certain Relationships and Related Transactions, and Director Independence. 154 Item 14. Principal Accountant Fees and Services. 154 PART IV Item 15. Exhibit and Consolidated Financial Statement Schedules. 155 Item 16. Form 10K Summary. 159

SIGNATURES

SIGNATURES 160 Unless the context suggests otherwise, references in this Annual Report on Form 10K, or the Annual Report, to "us," "our," "Olema," "Olema Pharmaceuticals," "we," the "Company" and similar designations refer to Olema Pharmaceuticals, Inc. and, where appropriate, its subsidiary. 2 Table of Contents SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report contains forward-looking statements that involve risks, uncertainties and assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Annual Report that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements are often identified by the use of words such as, but not limited to, "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. Forward-looking statements in this Annual Report include, but are not limited to, statements about: our financial performance; the sufficiency of our existing cash to fund our future operating expenses and capital expenditure requirements; the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; the scope, progress, results and costs of developing palazestrant (OP1250), OP-3136 or any other product candidates we may develop, and conducting nonclinical studies

Business

Item 1. Business . Overview We are a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of next generation targeted therapies for women's cancers. We are advancing our pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a novel, orally-available small molecule with dual activity as both a complete estrogen receptor, or ER, antagonist, or CERAN, and selective ER degrader, or SERD, currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive, or ER+, human epidermal growth factor receptor 2-negative, or HER2-, breast cancer. In preclinical models, palazestrant binds and completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer including activity in central nervous system, or CNS, metastases models. In clinical studies across more than 250 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. Palazestrant is currently being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 2 combination studies with a CDK4/6 inhibitor (palbociclib or ribociclib) and a phosphatidylinositol 3 kinase alpha, or PI3K a, inhibitor (alpelisib). We reported positive Phase 2 clinical results for palazestrant as a monotherapy in October 2023 at the European Society for Medical Oncology, or ESMO, Congress 2023, which demonstrated compelling progression-free survival, or PFS, a favorable tolerability profile and attractive pharmacokinetics in a heavily pretreated patient population. These results validated the potential opportunity for palazestrant as a monotherapy agent i

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View this 10-K filing on SEC EDGAR