On March 1, 2022 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Repare Therapeutics, MAR 1, 2022, View Source [SID1234609282]).
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"We achieved several key milestones in 2021 to advance our innovative, synthetic lethality-based pipeline across multiple clinical programs," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We are particularly pleased with important progress in our RP-3500 program and to have initiated our second clinical program, RP-6306, a first-in-class oral PKMYT1 inhibitor, and look forward to starting IND-enabling studies of our Polθ inhibitor program in the first half of 2022 as part of our growing clinical pipeline."
Mr. Segal added: "2022 is expected to be another exciting year for Repare, beginning in the first quarter 2022 with the Phase 2 (Module 2) expansion of the RP-3500 TRESR trial and the initiation of the TRESR Phase 1 monotherapy pediatric module in the first quarter of 2022. We anticipate comprehensive monotherapy TRESR Module 1 clinical data in the second quarter of 2022, and also look forward to initial data from the Phase 1 RP-6306 monotherapy MYTHIC trial in late 2022."
2021 Highlights and 2022 Outlook:
Announced initial Phase 1 RP-3500 monotherapy data from Phase 1/2 TRESR trial at AACR (Free AACR Whitepaper)-NCI-EORTC
Initial Phase 1 results provided clinical proof of concept and validated Repare’s SNIPRx platform for molecular selection of tumors for therapy with RP-3500.
Preliminary data showed that monotherapy RP-3500 appears safe and well tolerated, with compelling early efficacy signals across multiple genotypes and tumor types in heavily pretreated patients.
Recommended Phase 2 dose and schedule for further monotherapy RP-3500 evaluation was determined to be 160mg, taken weekly for 3 days on and 4 days off.
Key TRESR Milestones in 2022:
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 (ataxia telangiectasia mutated kinase), in tumors with ATM loss of function and in tumors with other STEP2 genomic alteration in February 2022.
Initiated recruitment in a Phase 1 pediatric module of TRESR trial of RP-3500 monotherapy and enrollment of a first patient is expected in the first quarter of 2022.
Comprehensive monotherapy Phase 1 (Module 1) clinical data from 120 patients enrolled in the Phase 1/2 TRESR trial of RP-3500 is expected in the second quarter of 2022.
Determination of recommended Phase 2 dose of RP-3500 in combination with gemcitabine, a trial that began enrolling patients in December 2021, is 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 in combination with, collectively, three marketed PARP inhibitors is expected in the third quarter of 2022.
Advanced RP-6306, a first-in-class, oral PKMYT1 inhibitor both as monotherapy and in combination with gemcitabine and in combination with FOLFIRI
In December 2021, the Company began dosing in a Phase 1 clinical trial of RP-6306, a first-in-class small molecule candidate targeting PKMYT1, in combination with gemcitabine for the treatment of molecularly selected advanced solid tumors.
In February 2022, the Company initiated recruitment in the Phase 1 MINOTAUR clinical trial of RP-6306 in combination with FOLFIRI for the treatment of molecularly selected advanced solid tumors.
Early readout of monotherapy Phase 1 clinical data is expected in late 2022.
Advanced the development of earlier stage discovery programs
The Company is expected to initiate IND-enabling studies of its third synthetic lethal asset, the Polθ inhibitor program, in the first half of 2022.
Recent Corporate Updates:
Appointed Philip Herman to Executive Leadership Team as EVP Commercial & New Product Development
In January 2022, the Company appointed Philip Herman as EVP Commercial & New Product Development. Mr. Herman was most recently Chief Commercial Officer of Y-mAbs Therapeutics and led the successful launch of DANYELZA (naxitamab).
In November 2021, the Company announced the closing of an upsized follow-on public offering yielding aggregate gross proceeds of approximately $101.2 million, or net proceeds of approximately $94.3 million, after deducting underwriting commissions and offering expenses of $0.8 million.
Fourth Quarter and Full Year 2021 Financial Results:
Cash and cash equivalents and marketable securities: Cash and cash equivalents and marketable securities as of December 31, 2021 were $341.9 million, including the proceeds from the follow-on public offering in November 2021. Repare believes its current cash and cash equivalents and marketable securities will be sufficient to fund planned operations through 2023.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $28.0 million and $90.0 million for the three and twelve month periods ended December 31, 2021, respectively, as compared to $12.4 million and $40.1 million for the three and twelve month periods ended December 31, 2020. The increase in Net R&D expenses for the three and twelve month periods were primarily due to increases in development costs related to the Company’s RP-3500 and RP-6306 programs, as well as increases in personnel related expenses, including share-based compensation.
General and administrative (G&A) expenses: G&A expenses were $7.6 million and $26.2 million for the three and twelve month periods ended December 31, 2021, respectively, as compared to $4.8 million and $14.3 million for the three and twelve month periods ended December 31, 2020, respectively. The increase in G&A expenses for the three and twelve month periods were due to personnel related costs, including share-based compensation and, for the twelve month period, the increase was also due to D&O insurance which increased as a result of the Company’s IPO in June 2020.
Net loss: Net loss was $28.3 million, or $0.70 per share and $106.9 million, or $2.83 per share, in the three and twelve month periods ended December 31, 2021, respectively, and $15.3 million, or $0.41 per share and $53.4 million, or $2.66 per share in the three and twelve month periods ended December 31, 2020, respectively.
About Repare Therapeutics’ SNIPRx Platform
Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those patients most likely to achieve clinical benefit from resulting product candidates.