Olema Pharmaceuticals Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
UNITED STATES
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FORM
CURRENT REPORT
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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 December 9, 2024, Olema Pharmaceuticals, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) has cleared its Investigational New Drug (“IND”) application for OP-3136, a novel small molecule that potently and selectively inhibits KAT6, a validated epigenetic target that is dysregulated in breast and other cancers. A copy of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
On December 10, 2024, the Company announced updated clinical results from its ongoing Phase 1b/2 study of palazestrant in combination with CDK4/6 inhibitor (“CDK4/6i”), ribociclib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (“ER+/HER2-”) advanced or metastatic breast cancer. A copy of the press release issued in connection with the announcement is being furnished as Exhibit 99.2 to this Current Report on Form 8-K.
On December 10, 2024, the Company made available on its website a presentation to be shared with investors and others from time to time. A copy of this presentation is being furnished as Exhibit 99.3 to this Current Report on Form 8-K.
The information in Exhibits 99.1, 99.2, and 99.3 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.
FDA Clearance of Investigational New Drug Application for OP-3136
On December 9, 2024, the Company announced that the FDA has cleared its IND application for OP-3136.
The Company expects to initiate the Phase 1 clinical trial in early 2025.
Interim Results from the Phase 1b/2 Study of Palazestrant in Combination with Ribociclib
On December 10, 2024, the Company announced updated clinical results from its ongoing Phase 1b/2 study of palazestrant in combination with CDK4/6 inhibitor, ribociclib in patients with ER+/HER2- advanced or metastatic breast cancer. Results as of a data cutoff date of September 25, 2024 will be presented at the San Antonio Breast Cancer Symposium (“SABCS”) being held December 10-13, 2024. Updated results as of a data cutoff date of November 11, 2024 are detailed below.
Enrollment
62 patients with advanced or metastatic ER+/HER2- breast cancer were treated with palazestrant (n=56 at the recommended Phase 2 dose of 120 mg once daily continuously) plus ribociclib (600 mg once daily, three weeks on treatment followed by one week off treatment).
Efficacy
Palazestrant combined with ribociclib showed promising clinical activity including tumor responses, prolonged disease stabilization, and progression-free survival (“PFS”) in patients with ESR1wild-type and ESR1 activating mutations at baseline and in those previously treated with one or two lines of CDK4/6i. Efficacy data continue to mature; 30 (48%) patients remained on treatment as of the November 11, 2024 data cutoff date, and the longest duration on treatment was approximately 18 months (79 weeks) and was ongoing as of the data cutoff date of November 11, 2024.
1 CBR is the proportion of patients who remained on treatment through at least 24 weeks with a confirmed complete response or partial response, or stable disease.
Safety and Tolerability
Across 62 treated patients, the combination of up to 120 mg of palazestrant with the approved dose for metastatic disease of 600 mg of ribociclib daily was well tolerated with no new safety signals or increase in toxicity. The overall safety profile was consistent with the established safety profile of ribociclib 600 mg plus an endocrine therapy.
Pharmacokinetics
Palazestrant did not affect ribociclib drug exposure when compared with published exposure data for single-agent ribociclib. Steady-state trough values showed no clinically significant difference between the combination and single-agent palazestrant.
Conclusions
Findings from this study support the advancement of palazestrant in combination with ribociclib into clinical development for the first-line treatment of ER+/HER2- advanced or metastatic breast cancer.
Forward Looking Statements
Statements contained in this Current Report on Form 8-K, including the exhibits 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,” “believe,” “could,” “expect,” “will,” “may,” “goal,” “may,” “potential,” “upcoming,” “will,” 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 the advancement of OP-3136 into clinical development, including timelines for initiation and enrollment for potential clinical studies, the combinability of OP-3136 with other drugs and potential beneficial characteristics, including but not limited to safety, tolerability, activity, efficacy and therapeutic effects of OP-3136 as a monotherapy and in combination with other drugs, potential beneficial characteristics, safety, tolerability, efficacy, and therapeutic effects of palazestrant, and the development of palazestrant, in each case, including in combination with other drugs, the potential of palazestrant to work in combination with ribociclib to suppress tumor growth or extend PFS, palazestrant in combination with ribociclib advancing into clinical development for the first-line treatment of ER+/HER2- advanced or metastatic breast cancer, the timing and likelihood of initiating clinical trials, and the timing of generating and announcing trial results, the timing and content of potential New Drug Application submissions, and commercial launch of product candidates, including the timing thereof. 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 September 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. |
Description |
104 |
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: |
December 10, 2024 |
By: |
/s/ Shane Kovacs |
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Shane Kovacs |