Repare Therapeutics

Repare Therapeutics narrowed its Q2 2025 GAAP loss per share to $0.39, significantly beating analyst estimates of -$0.56, primarily driven by a $5.7 million gain from technology platform licensing deals.

Repare Therapeutics has entered into an exclusive worldwide licensing agreement with Debiopharm for lunresertib, a first-in-class PKMYT1 inhibitor targeting difficult-to-treat solid tumors.

Repare Therapeutics has out-licensed its discovery platforms to newly-launched DCx Biotherapeutics for $4 million upfront plus equity stake and potential milestone payments, allowing Repare to focus on its clinical-stage oncology assets.

• Repare Therapeutics' phase I trial of lunresertib and camonsertib in gynecological cancers with specific biomarkers showed mixed results, impacting stock prices. • Beigene secured a global licensing agreement with CSPC for SYH-2039, a phase I MAT2A inhibitor targeting solid tumors, for up to $1.5 billion. • A new study identifies inceptor as a novel insulin receptor that degrades insulin, potentially opening new avenues for diabetes therapeutics. • GC Biopharma will acquire Abo Holdings for $96.28 million to enhance its U.S. plasma business and accelerate the entry of Alyglo (IVIG-SN 10%).

• Repare Therapeutics' shares fell 38% following Phase 1 results of lunresertib and camonsertib in endometrial and platinum-resistant ovarian cancers. • The combination therapy showed a 25.9% overall response rate in endometrial cancer and 37.5% in platinum-resistant ovarian cancer patients. • A significant safety concern arose, with 26.9% of patients experiencing Grade 3 adverse events, including anemia, during the trial. • Despite mixed results, Repare plans to initiate a Phase 3 registrational study in endometrial cancer in the second half of 2025.

• Repare Therapeutics' MYTHIC Phase 1 trial shows Lunre+Camo achieved a 25.9% ORR in endometrial cancer and 37.5% in platinum-resistant ovarian cancer. • Nearly half of gynecologic cancer patients maintained progression-free survival at 24 weeks, suggesting a potential improvement over current standards of care. • Repare plans to initiate a Phase 3 trial for Lunre+Camo in endometrial cancer in the second half of 2025, pending regulatory clearance. • The combination therapy demonstrated a favorable tolerability profile, with anemia being the most common Grade 3 adverse event.

• Repare Therapeutics will present Phase 1 MYTHIC trial data for lunresertib combined with camonsertib in platinum-resistant ovarian and endometrial cancers. • The trial focuses on patients with CCNE1 amplification or FBXW7 or PPP2R1A mutations, evaluating the combination at the recommended Phase 2 dose. • The presentation will occur during a live webcast on December 12, 2024, featuring Repare's management and Dr. Brian Slomovitz from Mount Sinai Medical Center. • The MYTHIC trial assesses the safety and efficacy of this novel therapeutic approach in addressing genomic instability in advanced cancers.

• Repare Therapeutics and the National Cancer Institute (NCI) have entered a Cooperative Research and Development Agreement (CRADA) to further develop camonsertib. • The collaboration aims to explore camonsertib's potential as an anticancer agent, including combination studies with radiation therapy and biomarker identification. • Camonsertib has shown promising anti-tumor activity in clinical trials, particularly in ATM-mutated non-small cell lung cancer and ATM-altered tumors. • The partnership seeks to leverage CTEP's resources to accelerate camonsertib's clinical development and broaden its application across cancer types.

• Repare Therapeutics is set to report Phase 2 dose expansion data for lunresertib plus camonsertib in platinum-resistant ovarian and endometrial cancers in December. • Updated Phase 1 data showed improved safety and tolerability of lunresertib through individualized dosing schedules to manage anemia. • The first patient was dosed in the POLAR trial evaluating RP-3467 alone or with olaparib in advanced solid tumors.

Repare Therapeutics presented data on an individualized dosing schedule of lunresertib and camonsertib in the Phase 1 MYTHIC trial.