OLMA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-12

• In November 2023, we initiated OPERA-01, our pivotal Phase 3 clinical trial of palazestrant as a monotherapy in second/third-line ER+/HER2- MBC. We anticipate top-line results for this trial in the fall of 2026, expect to submit the new drug application (NDA) in 2027, and, if successful, anticipate …

• In addition, we are investigating palazestrant in multiple Phase 1/2 studies in combination with CDK4/6 inhibitors (palbociclib or ribociclib), a phosphatidylinositol-3-kinase alpha (PI3Ka) inhibitor (alpelisib), with an mTOR inhibitor (everolimus), and a CDK4 inhibitor (atirmociclib). In October 20…

• Medical Oncology, we presented updated results from the ongoing Phase 1b/2 clinical trial of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or MBC. This data further support our thesis that palazestrant possesses key characteristics to make it a potential backbone en…

• Our second product candidate in clinical development, called OP-3136, is a novel, orally-available small molecule that potently and selectively inhibits KAT6, an epigenetic target that is dysregulated in breast and other cancers. The Investigational New Drug (IND) application for OP-3136 was cleared…

• Global economic and business activities continue to face widespread uncertainty due to the geopolitical and macroeconomic environment, generally, including economic and geopolitical uncertainty, market volatility, labor shortages, evolving trade and tariffs policies, including related legal challeng…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• Our pivotal Phase 3 clinical trial of palazestrant as a monotherapy in second/third-line ER+/HER2- MBC, OPERA-01, is ongoing. 90mg of once-daily palazestrant has been selected as the dose for Part 2 of OPERA-01. We anticipate top-line results for this trial in the second half of 2026, expect to subm…

• Application in 2027, and anticipate U.S. Food and Drug Administration (FDA) approval and commercial launch in late 2027.

• In combination, we are investigating palazestrant in multiple Phase 1/2 studies with CDK4/6 inhibitors (palbociclib or ribociclib), a phosphatidylinositol-3-kinase alpha (PI3Ka) inhibitor (alpelisib), with an mTOR inhibitor (everolimus). We have also entered into a clinical trial collaboration and s…

• We presented updated results from the ongoing Phase 1b/2 study of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or MBC at the San Antonio Breast Cancer Symposium (SABCS) in December 2024. In March 2025, we disclosed updated median progression-free survival (mPFS) fr…

• In October 2025, we presented updated data from this study at the European Society for Medical Oncology (ESMO) Congress. As of the data cutoff date of July 8, 2025, in the 120 mg palazestrant dose cohort, with a median follow-up of more than 19 months, mPFS are mature. mPFS was 15.5 months for all p…

Text added vs the prior filing · source: 10-Q · 2026-05-12

• We may be unable to obtain U.S. or foreign regulatory approvals and, as a result, may be unable to commercialize palazestrant, OP-3136, or any future product candidates we may develop.

• Unfavorable U.S. and global macroeconomic and geopolitical conditions could adversely affect our business, financial condition, results of operations, and prospects.

• If we default under the Loan Agreement, the Bank may accelerate all of our repayment obligations and exercise all of its rights and remedies under the Loan Agreement and applicable law, potentially requiring us to renegotiate our agreement on terms less favorable to us. Further, if we are liquidated…

• The regulatory approval processes of the FDA, European Commission, and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for palazestrant, OP-3136, or any future product candidates we may develop, ou…

• The time required to obtain approval by the FDA, European Commission, and comparable foreign authorities is unpredictable and typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• Unfavorable U.S. and global macroeconomic and geopolitical conditions could adversely affect our business, financial condition and results of operations.

• market conditions, use our available cash flow to fund future acquisitions and make dividend payments, and obtain additional financing for working capital, to fund growth or for general corporate purposes, even when necessary to maintain adequate liquidity.

• If we default under the Loan Agreement, the Bank may accelerate all of our repayment obligations and exercise all of its rights and remedies under the Loan Agreement and applicable law, potentially requiring us to renegotiate our agreement on terms less favorable to us. Further, if we are liquidated…

• results of subsequent clinical trials. We have a limited operating history and to date have not demonstrated our ability to complete large-scale clinical trials.

• of palazestrant or OP-3136, including and any other indication we are seeking for approval under palazestrant or OP-3136.

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• (1) We inadvertently omitted from Item 5 of Part II of our Quarterly Report on Form 10-Q for the quarterly period ending March 31, 2025, the disclosure of the adoption of a contract, instruction or written plan for the purchase or sale of our securities.

• (2) This plan was intended to qualify as a “Rule 10b5-1 trading arrangement” as defined in Item 408(a) of Regulation S-K. However, the plan did not comply with the cooling-off period required by Exchange Act Rule 10b5-1(c) and is therefore deemed a “Non-Rule 10b5-1 trading arrangement”.

• (3) This contract, instruction, or written plan was subsequently terminated on September 10, 2025, as disclosed above, prior to the completion of any sales under the plan.

• (4) Represents the termination of a written plan originally adopted on February 3, 2025 that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.