Repare Therapeutics Updates Business, Clinical Progress, and Q1 2024 Financials

Repare Therapeutics Inc., a clinical-stage precision oncology company, has outlined significant milestones for the first quarter ending March 31, 2024. According to the company’s CEO, Lloyd M. Segal, Repare is making strides in the development of its four proprietary compounds, aiming to present updated data by the end of 2024, with the potential for a registrational trial in 2025.

The company has made substantial progress in its Phase 1 MYTHIC clinical trial, which assesses lunresertib in combination with camonsertib. The trial has led to a notable reduction in Grade 3 anemia from 45% to 25% in patients treated at the recommended Phase 2 dose (RP2D). The U.S. Food and Drug Administration (FDA) has agreed with this dosage, and Repare plans to present updated data on this combination therapy for ovarian and endometrial cancer in the fourth quarter of 2024.

Additionally, the first patient was dosed in April 2024 for the Phase 1 MYTHIC trial evaluating lunresertib in combination with Debio 0123, a selective WEE1 inhibitor. Preliminary results from this trial are expected in 2025, focusing on safety, tolerability, and preliminary efficacy.

Repare has also observed promising results from its Phase 1 MINOTAUR trial, which evaluates lunresertib in combination with FOLFIRI for advanced solid tumors. The data, which shows no significant additional toxicities over FOLFIRI alone, will be presented at the European Society of Medical Oncology (ESMO) Gastrointestinal Cancers Congress in June 2024.

In the realm of monotherapy, Repare has regained global development and commercialization rights for camonsertib from Roche. The company is initiating a Phase 2 TRESR expansion to evaluate camonsertib in approximately 20 patients with ATM-mutated non-small cell lung cancer (NSCLC). Initial data from this trial is anticipated in 2025.

Moreover, Repare is progressing with its RP-1664 PLK4 inhibitor. The first patient was dosed in February 2024 in the Phase 1 LIONS trial, which targets patients with TRIM37-high and other biomarkers. The company also plans to initiate a Phase 1 trial for RP-3467, a Polθ ATPase inhibitor, in the second half of 2024.

Financially, Repare reports robust health with $237.0 million in cash and equivalents as of March 31, 2024, ensuring the sustainability of its clinical programs until mid-2026. The company earned $52.4 million in revenue from collaboration agreements in the first quarter of 2024, a significant increase from $5.7 million in the same period in 2023, largely due to a $40.0 million milestone payment from Roche.

Research and development (R&D) expenses for the quarter were $33.0 million, a slight increase from $31.8 million in the previous year, reflecting the advanced stages of the lunresertib clinical program. General and administrative expenses remained relatively stable at $8.6 million compared to $8.5 million in the prior year.

Repare has also made strategic leadership changes, appointing Steven H. Stein, M.D., to its Board of Directors, effective June 2024. This appointment comes as Todd Foley, who has served on the Board for over seven years, decided not to seek re-election.

In terms of future milestones, the company plans to report initial data from its Phase 1 MINOTAUR trial at ESMO GI in June 2024, expand camonsertib monotherapy to NSCLC, and initiate a Phase 1 trial for RP-3467 by the second half of 2024. By the end of 2024, additional data from the MYTHIC trial will be available, and by 2025, Repare expects to release data from the lunresertib and Debio 0123 combination, camonsertib monotherapy in NSCLC, and potentially start its first pivotal trial for lunresertib and camonsertib.

Repare Therapeutics continues to leverage its synthetic lethality approach and SNIPRx platform to develop highly targeted cancer therapies, focusing on genomic instability and DNA damage repair. The company's ongoing and future trials underscore its commitment to advancing precision oncology.