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Dec 31, 2021
Repare Therapeutics Q4 2021 Earnings Report
Repare Therapeutics' fourth quarter and full year 2021 financial results were reported, with key milestones achieved in advancing the company's synthetic lethality-based pipeline.
Key Takeaways
Repare Therapeutics reported a net loss of $28.3 million for Q4 2021, with cash and cash equivalents and marketable securities totaling $341.9 million as of December 31, 2021. The company believes its current financial resources will fund operations through 2023. Key progress was made in the RP-3500 and RP-6306 programs.
Initial Phase 1 RP-3500 monotherapy data from Phase 1/2 TRESR trial at AACR-NCI-EORTC provided clinical proof of concept and validated Repare’s SNIPRx platform.
RP-3500 monotherapy appears safe and well tolerated, with compelling early efficacy signals across multiple genotypes and tumor types in heavily pretreated patients.
Initiated a monotherapy Phase 2 TRESR trial of RP-3500 for the treatment of solid tumors with specific synthetic-lethal genomic alterations including those in the ATM gene in February 2022.
In December 2021, the Company began dosing in a Phase 1 clinical trial of RP-6306 in combination with gemcitabine for the treatment of molecularly selected advanced solid tumors.
Repare Therapeutics
Repare Therapeutics
Forward Guidance
Repare Therapeutics anticipates several key milestones in 2022, including the Phase 2 expansion of the RP-3500 TRESR trial, initiation of the TRESR Phase 1 monotherapy pediatric module, and initial data from the Phase 1 RP-6306 monotherapy MYTHIC trial.
Positive Outlook
- Initiation of a monotherapy Phase 2 TRESR trial of RP-3500 in February 2022.
- Initiation of recruitment in a Phase 1 pediatric module of TRESR trial of RP-3500 monotherapy with enrollment expected in Q1 2022.
- Comprehensive monotherapy Phase 1 (Module 1) clinical data from the TRESR trial of RP-3500 expected in Q2 2022.
- Determination of recommended Phase 2 dose of RP-3500 in combination with gemcitabine expected in the second half of 2022.
- Early clinical data readout for PARPi combination from Phase 1/2 TRESR trial and ATTACC trial of RP-3500 expected in Q3 2022.
Challenges Ahead
- Potential delays in clinical trial site activation or enrollment rates.
- Unexpected safety or efficacy data observed during preclinical studies or clinical trials.
- Changes in expected or existing competition.
- Changes in the regulatory environment.
- Uncertainties and timing of the regulatory approval process.