Recent Insider Transactions Derivative • Jul 23
Independent Director notifies of intention to sell stock Cyrus Harmon intends to sell 13k shares in the next 90 days after lodging an Intent To Sell Form on the 23rd of July. If the sale is conducted around the recent share price of US$11.58, it would amount to US$145k. Cyrus currently holds less than 1% of total shares outstanding. Company insiders have collectively sold US$21m more than they bought, via options and on-market transactions in the last 12 months. Announcement • May 24
Olema Pharmaceuticals, Inc. Announces Initial Clinical Data for Op-3136 and Provides Update on Product Pipeline Olema Pharmaceuticals, Inc. announced preliminary clinical data from the Phase 1 study of OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor. OP-3136 monotherapy was well-tolerated with no dose-limiting toxicities observed and no discontinuations due to treatment-related adverse events. OP-3136 shows evidence of anti-tumor activity across multiple solid tumor types. Data support the ongoing Phase 1 evaluation of OP-3136 as a monotherapy and in combination with fulvestrant and palazestrant. The Phase 1 study evaluates dose escalation followed by dose expansion of OP-3136 in patients with ER+/HER2- advanced breast cancer (ABC), metastatic castration-resistant prostate cancer (mCRPC), and metastatic non-small cell lung cancer (mNSCLC). In Part 1A, OP-3136 monotherapy was administered orally once daily in 28-day cycles across dose levels from 2 mg to 45 mg. As of the March 2, 2026 data cut-off, 32 heavily pretreated patients who became resistant or intolerant to standard of care treatments were enrolled in this cohort. OP-3136 monotherapy was well-tolerated with no dose-limiting toxicities observed across the evaluated daily dose range up to 45 mg per day orally. Most treatment-related adverse events (TRAEs) were grade 1 or 2; no grade 4 or 5 TRAEs were observed. TRAEs were manageable with dose modifications; no treatment discontinuations occurred due to TRAEs. The most common TRAEs were dysgeusia (81% any grade; 56% grade 1, 25% grade 2), anemia (38% any grade; 6% grade 3), and neutropenia (34% any grade; 28% grade 3). Among 19 response-evaluable patients across dose levels and tumor types, tumor shrinkage was observed in 13 patients; partial responses (PR) were observed in 3 patients with measurable disease, with 2 confirmed PRs and 1 unconfirmed PR. The longest duration of treatment is 62 weeks. 11 patients remain on treatment, including 9 with ABC and 2 with mCRPC. Across all doses tested, OP-3136 demonstrated rapid, sustained, and significant reduction in levels of lysine 23 of histone H3, a direct target of KAT6, consistent with on-target KAT6 inhibition. OP-3136 exhibited predictable, dose-proportional plasma exposure across all doses tested. At doses of 6 mg and above, steady-state concentrations exceeded efficacy targets based on preclinical models. OP-3136 Poster Presentation Details Title: A phase 1, first-in-human study of OP-3136, a novel oral selective KAT6A/B inhibitor, as monotherapy in advanced solid tumors and in combination with endocrine therapy in ER+, HER2- advanced breast cancer: preliminary results Abstract Number: 3088 Poster Number: 225 Date/Time: May 30, 2026 from 1:30pm-4:30pm CT /2:30pm-5:30pm ET OPERA-02 Trial-in-Progress Poster Presentation Details Olema will also present a trial-in-progress poster for the Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer. Title: OPERA-02: A phase 3 study of palazestrant plus ribociclib as first-line treatment of ER+, HER2- advanced breast cancer Abstract Number: TPS1152 Poster Number: 261b Date/Time: June 1, 2026 from 1:30pm-4:30pm CT /2:30pm-5:30pm ET OP-3136 is a novel, orally available small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies, including palazestrant and cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The Investigational New Drug (IND) application for OP-3136 was cleared by the U.S. Food and Drug Administration (FDA) in December 2024 and patients are currently enrolling in the Phase 1 clinical study. Live News • May 13
Olema Reports Encouraging Early Data for OP-3136 and Advances Phase 3 Palazestrant Trial Olema reported preliminary Phase 1 data for its oral KAT6 inhibitor OP-3136 in advanced solid tumors, with no dose-limiting toxicities observed up to 45 mg daily and treatment-related side effects described as manageable.
Tumor shrinkage was reported in 13 of 19 evaluable patients, including three partial responses, and 11 patients remain on therapy, with the longest treatment duration at 62 weeks.
The company plans further development of OP-3136 both as a standalone therapy and in combination regimens, and highlighted ongoing work on the Phase 3 OPERA-02 trial of palazestrant with ribociclib.
These early OP-3136 results indicate a potentially expanding pipeline focused on targeted oncology, alongside the more advanced palazestrant program already in Phase 3 testing.
Investors may wish to monitor how Olema allocates resources between OP-3136 and palazestrant and follow future updates on durability of response, safety, and regulatory milestones across both programs. 
