On August 6, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported financial results for the second quarter ended June 30, 2024 (Press release, Repare Therapeutics, AUG 6, 2024, View Source [SID1234645433]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continued to make meaningful progress across our clinical programs in the second quarter and we look forward to a catalyst-rich second half of 2024 that includes the release of data from our ongoing MYTHIC dose expansion clinical trial evaluating the promising combination of lunresertib and camonsertib at the recommended Phase 2 dose. This combination therapy has the potential to be a new treatment paradigm in genomically-defined platinum-resistant ovarian cancer and second-line endometrial cancer. We remain on track to deliver this data in the fourth quarter of this year, with the potential to begin a registrational trial in 2025," said Lloyd M. Segal, President and CEO of Repare. "As we prepare for potential near-term registrational clinical programs, we are thrilled that Dr. Steven H. Stein has joined Repare’s Board of Directors. He brings extensive experience in global pivotal trial development and will chair our Science and Technology Committee. He replaces Dr. Briggs Morrison, who has been instrumental in building Repare into a leading, precision oncology company. We are grateful for Dr. Morrison’s seven years of service, his substantial contributions to our company, and for his longstanding and ongoing support."

Second Quarter 2024 and Recent Portfolio Highlights:

▪
Lunresertib (RP-6306)
▪
Currently evaluating lunresertib in combination with camonsertib in Repare’s MYTHIC dose expansion clinical trial at the recommended Phase 2 dose (RP2D) in patients with platinum-resistant ovarian and endometrial cancers harboring CCNE1 amplification or FBXW7 or PPP2R1A mutations, which are predictive of poor prognosis. Repare expects to report data from approximately 20-30 patients in each cohort in the fourth quarter of 2024.
▪
In preparation for a potential registrational clinical trial start in 2025, Repare formed a collaboration with Foundation Medicine, Inc. to provide prospective genomic profiling for patients in the ongoing MYTHIC clinical trial. Additionally, Repare and Foundation Medicine are exploring opportunities to

develop FoundationOneCDx, a tissue-based comprehensive genomic profiling test, as a companion diagnostic for the lunresertib program.
▪
Granted Fast-Track designation by the U.S. Food and Drug Administration (FDA) in June 2024 for lunresertib in combination with camonsertib for the treatment of adult patients with CCNE1 amplified, or FBXW7 or PPP2R1A-mutated platinum-resistant ovarian cancer.
▪
Dosed the first patient in Module 4 of the ongoing MYTHIC clinical trial investigating lunresertib in combination with Debio 0123, an oral, brain-penetrant, highly selective WEE1 kinase inhibitor. Repare expects to report initial data from this module in 2025.
▪
Announced positive initial data from the ongoing Phase 1 MINOTAUR clinical trial evaluating lunresertib (RP-6306) in combination with FOLFIRI in patients with advanced solid tumors at the ESMO (Free ESMO Whitepaper) GI Cancers Congress in June 2024. The data showed the lunresertib combination therapy was well tolerated without excess toxicity above expected rates for lunresertib or standard FOLFIRI alone.
▪
Camonsertib (RP-3500)
▪
Dosed the first patient in the camonsertib monotherapy non-small cell lung cancer (NSCLC) expansion of the TRESR clinical trial. The NSCLC expansion is expected to enroll up to 20 patients with ATR-inhibitor sensitizing mutations in NSCLC to study the efficacy of camonsertib at the RP2D. Repare expects to report initial data from the TRESR trial in 2025.
▪
RP-1664
▪
Actively enrolling patients into the Phase 1 LIONS trial evaluating RP-1664, a potential first-in-class selective PLK4 inhibitor, in adult and adolescent patients with TRIM37-high advanced solid tumors and other biomarkers. The Company expects to rapidly advance RP-1664 into a Phase 1/2 clinical trial in pediatric patients with high risk, recurrent neuroblastoma, where the patients have a high prevalence of TRIM37-altered tumors, after evaluating the safety profile in the LIONS trial.
▪
RP-3467
▪
Initiation of a Phase 1 dose finding trial of RP-3467, a potential best-in-class Polθ ATPase inhibitor, is expected in the fourth quarter of 2024.
▪
Corporate
▪
Welcomed Steven H. Stein, M.D., Chief Medical Officer of Incyte Corporation, to Repare’s Board of Directors, effective as of June 17, 2024, the date of the Company’s annual meeting of shareholders. Effective today, Briggs Morrison, M.D. is stepping down from the Board after seven years of service.

Second Quarter 2024 Financial Results:

▪
Cash, cash equivalents and marketable securities: Cash, cash equivalents and marketable securities as of June 30, 2024 were $208.1 million. The Company believes that its cash, cash equivalents, and marketable securities are sufficient to fund its current operational plans at least into mid-2026.
▪
Revenue from collaboration agreements: Revenue from collaboration agreements were $1.1 million and $53.5 million for the three months and six months ended June 30, 2024, respectively, as compared to $30.2 million and $35.9 million for the three and six months ended June 30, 2023.

▪
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $30.1 million and $63.0 million for the three and six months ended June 30, 2024, respectively, as compared to $33.8 million and $65.6 million for the three and six months ended June 30, 2023.
▪
General and administrative (G&A) expenses: G&A expenses were $8.3 million and $16.9 million for the three and six months ended June 30, 2024, respectively, compared to $8.7 million and $17.2 million for the three and six months ended June 30, 2023.
▪
Net loss: Net loss was $34.8 million, or $0.82 per share, and $21.6 million, or $0.51 per share, in the three and six months ended June 30, 2024, respectively, compared to $11.9 million, or $0.28 per share, and $46.9 million, or $1.11 per share, in the three and six months ended June 30, 2023, respectively.