Olema Pharmaceuticals Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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Item 7.01 Regulation FD Disclosure.
On September 27, 2024, Olema Pharmaceuticals, Inc. (the “Company” or “Olema”) posted a corporate presentation to its website that will be shared with investors and others from time to time. A copy of this presentation is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
The Company plans to present non-clinical data for OP-3136, the Company's development candidate targeting KAT6, at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (“ENA”), which will be held October 23-25, 2024. An initial new drug (“IND”) application for OP-3136 is anticipated to be submitted in the fourth quarter of 2024 and the Phase 1/2 clinical study for OP-3136 is anticipated to begin in 2025.
The Company is also planning for a potential initiation of OPERA-02, a proposed Phase 3 clinical trial of palazestrant in combination with a CDK4/6 inhibitor, ribociclib, in 2025.
Forward Looking Statements
Statements contained in this Current Report on Form 8-K, including the exhibit furnished herewith, regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “expect,” “will,” “may,” “goal,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding upcoming data presentations, the timing and likelihood of submitting an IND application for OP-3136, the timing of the commencement of a Phase 1/2 clinical study for OP-3136, and the timing and likelihood of initiation of OPERA-02. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, and other filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those set forth in the forward-looking statements.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
99.1 |
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Corporate Presentation, dated September 27, 2024, of Olema Pharmaceuticals, Inc. |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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OLEMA PHARMACEUTICALS, INC. |
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Date: |
September 27, 2024 |
By: |
/s/ Shane Kovacs |
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Shane Kovacs |