What changed in this filing

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Item 9A. Controls and Procedures

2023-03-09 compared with 2022-02-28 · 61 added, 52 removed, 128 unchanged (47% of the section changed)

17 unchanged sentences

Based on its assessment, management concluded that our internal control over financial reporting was effective as of December 31, 2022 based on those criteria.

The effectiveness of our internal control over financial reporting as of December 31, 2021, has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in its attestation report which is set forth below in this Annual Report on Form 10-K.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the fourth quarter ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

We have not experienced any material impact to our internal controls over financial reporting despite the fact that most of our employees are working remotely due to the COVID-19 pandemic.

We are continually monitoring and assessing the COVID-19 situation to minimize the impact to the design and operating effectiveness of our internal controls .

Attestation Report of the Independent Registered Public Accounting Firm

Report of Independent Registered Public Accounting Firm

To the shareholders and the Board of Directors of Olema Pharmaceuticals, Inc.

Opinion on Internal Control Over Financial Reporting

We have audited Olema Pharmaceuticals, Inc.’s (the Company’s) internal control over financial reporting as of December 31, 2021, based on criteria established in Internal Control — Integrated Framework issued by the

Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), (the COSO criteria).

In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2021, based on the COSO criteria .

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2021 and 2020, and the related consolidated statements of operations and comprehensive loss, convertible preferred stock and stockholders’ equity (deficit), and cash flows for each of the three years in the period ended December 31, 2021, and the related notes and our report dated February 28, 2022 expressed an unqualified opinion thereon.

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management's Report on Internal Control Over Financial Reporting.

Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.

Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances.

We believe that our audit provides a reasonable basis for our opinion.

Definition and Limitations of Internal Control Over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.

A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;

(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;

and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

/s/ Ernst & Young LLP

Iselin, New Jersey

February 28, 2022

Other Information.

In November 2021, we were alerted to falsified information circulating on social media relating to our planned poster presentation for the Phase 1 dose-escalation portion of the ongoing Phase 1/2 clinical trial of OP-1250 at the San Antonio Breast Cancer Symposium.

The falsified poster image was not released or authorized by us.

In December 2021, a Special Committee of our Board of Directors, with assistance of outside counsel, initiated an investigation into the circumstances regarding these matters.

The Special Committee’s outside counsel contacted the SEC to inform of the Special Committee’s investigation.

Costs Associated with Exit or Disposal Activities

On March 9, 2023, we announced a corporate restructuring and portfolio prioritization to focus our resources on the late-stage clinical development of OP-1250 for the treatment of ER+/HER2- metastatic breast cancer.

As part of this restructuring, our workforce will be reduced by approximately 25%, affecting employees across research, early development, and general and administrative functions.

This workforce reduction is expected to be completed by the end of the first quarter of 2023.

Affected employees will be eligible to receive severance and other benefits, contingent upon such employee’s execution and the effectiveness of a separation agreement, which includes a general release of claims against us.

We estimate that these severance and other costs will result in a one-time accounting charge of approximately $2.8 million in the first quarter of 2023, $2.7 million of which is attributable to cash expenditures expected to be paid in the same quarter, and expect that payment of these costs will also be made in the first quarter of 2023.

The charges that we expect to incur in connection with the restructuring are subject to a number of assumptions, and actual results may differ materially.

We may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the restructuring.

Departure of Directors or Certain Officers;

Compensatory Arrangements of Certain Officers

As part of the restructuring, each of Kinney Horn, our Chief Business Officer, and Cyrus Harmon, Ph.D., our Chief Research Officer, will cease their employment with us, effective March 24, 2023, or the Separation Date, and has entered into a separation agreement with us.

Pursuant to the separation agreement entered into with Mr.

Horn, subject to the effectiveness of a general release of claims, Mr.

Horn will (i) receive 12 months of his base salary and medical insurance coverage premiums, plus a pro-rated portion of his target bonus for 2023, for a total of approximately $0.5 million, less required deductions and withholdings, (ii) provide ongoing consulting and advisory services to us until such services are terminated by us or Mr.

Horn pursuant to the terms of a consulting agreement, and (iii) upon the Separation Date and pursuant to the terms of his existing employment agreement with us, be entitled to accelerated vesting of options to purchase 39,384 shares of our common stock held as of the Separation Date.

Pursuant to the separation agreement entered into with Dr.

Harmon, subject to the effectiveness of a general release of claims, Dr.

Harmon will be entitled to receive 12 months of his base salary and medical insurance coverage premiums, plus a pro-rated portion of his target bonus for 2023, for a total of approximately $0.6 million, less required deductions and withholdings.

We expect that Dr.

Harmon will continue in his role as a member of our Board of Directors.

“At the Market” Equity Offering Program

On March 9, 2023, we entered into a Sales Agreement, or the ATM Agreement, with Oppenheimer & Co., Inc., or the Agent, pursuant to which we may offer and sell, from time to time through the Agent, at our option, shares of our common stock for aggregate sales proceeds of up to $100 million, or the Shares.

The issuance and sale, if any, of Shares under the ATM Agreement will be pursuant to our effective registration statement on Form S-3 (File No.

333-263117), and the related prospectus supplement dated March 9, 2023, in each case filed with the SEC.

Pursuant to the ATM Agreement, the Agent may sell the Shares in sales deemed to be “at-the-market” equity offerings as defined in Rule 415 promulgated under the Securities Act, including sales made directly on or through the Nasdaq Global Select Market.

We may sell Shares in amounts and at times to be determined by us from time to time through the Agent and subject to the terms and conditions of the ATM Agreement, but we have no obligation to sell any of the Shares under the ATM Agreement.

The offer and sale of the Shares pursuant to the ATM Agreement will terminate upon the earlier of (a) the issuance and sale of all of the Shares subject to the ATM Agreement or (b) the termination of the ATM Agreement.

We have agreed to pay the Agent a commission of up to 3.0% of the aggregate gross proceeds from any Shares sold by the Agent and to provide the Agent with customary indemnification and contribution rights, including for liabilities under the Securities Act.

We also will reimburse the Agent for certain specified expenses in connection with entering into the ATM Agreement.

The ATM Agreement contains customary representations and warranties and conditions to the placements of the Shares pursuant thereto.

The foregoing summary of the ATM Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the ATM Agreement, which is attached as Exhibit 1.1 to this Annual Report on Form 10-K.

Cooley LLP, counsel to Olema, has issued a legal opinion relating to due authorization and valid issuance of the Shares, a copy of which, including the consent included therein, is attached as Exhibit 5.1 to this Annual Report on Form 10-K.

This Annual Report on Form 10-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any offer, solicitation, or sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

6 unchanged sentences

The Code of Conduct is available on our corporate website at https://www.olema.com/ in the Investors & Media section under “Corporate Governance.” If we make any substantive amendments to our Code of Conduct or grant any of our directors or executive officers any waiver, including any implicit waiver, from a provision of our Code of Conduct, we will disclose the nature of the amendment or waiver on our website or in a Current Report on Form 8-K.

Information contained in, or that can be accessed through, our website is not incorporated by reference herein, and you should not consider information on our website to be part of this Annual Report.

Executive Compensation.

1 unchanged sentence

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

Information required by this item regarding security ownership of certain beneficial owners and management is incorporated by reference to the information set forth under the caption “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation” in our Proxy Statement.

Certain Relationships and Related Transactions, and Director Independence.

11 unchanged sentences

Incorporation by Reference

Sales Agreement by and between Registrant and Oppenheimer & Co.

Inc., dated March 9, 2023.

Amended and Restated Certificate of Incorporation .

3 unchanged sentences

Description of Capital Stock .

Opinion of Cooley LLP.

Olema Pharmaceuticals, Inc.

4 unchanged sentences

2020 Equity Incentive Plan.

Incorporation by Reference

Forms of Stock Option Grant Notice and Stock Option Agreement under the Olema Pharmaceuticals, Inc.

2020 Equity Incentive Plan.

Incorporation by Reference

Forms of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under the Olema Pharmaceuticals, Inc.

12 unchanged sentences

Amended and Restated Offer Letter by and between the Registrant and David Myles, dated November 13, 2020.

Incorporation by Reference

Amended and Restated Offer Letter by and between the Registrant and John B.

Moriarty, Jr., dated November 13, 2020.

Incorporation by Reference

Clinical Collaboration and Supply Agreement by and between the Registrant and Novartis Institutes for BioMedical Research, Inc., dated July 22, 2020.

3 unchanged sentences

Offer Letter by and between the Registrant and Naseem Zojwalla, dated December 15, 2021.

Drug Discovery Collaboration and License Agreement by and between the Registrant and Aurigene Discovery Technologies Limited, dated June 7, 2022 .

Subsidiaries of the Registrant as of December 31, 2022.

Consent of Independent Registered Public Accounting Firm.

Consent of Cooley LLP (included in Exhibit 5.1).

Power of Attorney (included on the Signatures page of this Annual Report on Form 10-K).

Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

Incorporation by Reference

Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

4 unchanged sentences

XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL Document

Incorporation by Reference

XBRL Taxonomy Extension Schema Document

5 unchanged sentences

# Indicates management contract or compensatory plan or arrangement.

† The certifications attached as Exhibit 32.1 and Exhibit 32.2 that accompany this Annual Report are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report, irrespective of any general incorporation language contained in such filing.

† The certifications attached as Exhibit 32.1 and Exhibit 32.2 that accompany this Annual Report on Form 10-K are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation language contained in such filing.

Pursuant to Item 601(b)(10) of Regulation S-K, portions of this exhibit have been omitted as the Registrant has determined that the omitted information is the type that the Registrant customarily and actually treats as private or confidential and is not material.

Form 10-K Summary.

1 unchanged sentence

Olema Pharmaceuticals, Inc.

February 28, 2022

/s/ Sean Bohen

March 9, 2023

/s/ Sean Bohen, M.D., Ph.D.

Sean Bohen, M.D., Ph.D.

2 unchanged sentences

Olema Pharmaceuticals, Inc.

February 28, 2022

March 9, 2023

/s/ Shane Kovacs

5 unchanged sentences

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

/s/ Sean Bohen

/s/ Sean Bohen, M.D., Ph.D.

President, Chief Executive Officer and Director

February 28, 2022

March 9, 2023

Sean Bohen, M.D., Ph.D.

( Principal Executive Officer )

1 unchanged sentence

Chief Operating and Financial Officer

February 28, 2022

March 9, 2023

( Principal Financial and Accounting Officer )

/s/ Ian Clark

February 28, 2022

March 9, 2023

/s/ Cynthia Butitta

February 28, 2022

March 9, 2023

Cynthia Butitta

February 28, 2022

March 9, 2023

/s/ Sandra J.

Horning, M.D.

February 28, 2022

March 9, 2023

Horning, M.D.

/s/ Gorjan Hrustanovic, Ph.D.

February 28, 2022

March 9, 2023

Gorjan Hrustanovic, Ph.D.

/s/ Yi Larson

February 28, 2022

March 9, 2023

/s/ Andrew Rappaport

February 28, 2022

March 9, 2023

Andrew Rappaport

/s/ Graham Walmsley, M.D., Ph.D.

February 28, 2022

March 9, 2023

Graham Walmsley, M.D., Ph.D.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures