Repare Therapeutics Provides Business Update and Reports Third Quarter 2021 Financial Results
Oral presentation of initial data from the Phase 1/2 TRESR trial at the AACR-NCI-EORTC conference
Results demonstrated favorable and differentiated safety profile, along with promising early activity, for RP-3500 in patients with a range of synthetic-lethal genomic alterations
Gross Proceeds of $101.2 Million Raised in Upsized Follow-on Public Offering
Thomas Civik appointed to Board of Directors as new Chairman
CAMBRIDGE, Mass. & MONTREAL--(BUSINESS WIRE)--November 10, 2021--
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, today reported financial results for the third quarter ended September 30, 2021.
"We are pleased with the progress we've made this quarter in our Phase 1 part of the RP-3500 program, including the comprehensive safety data and emerging evidence of activity from the TRESR study which was part of the featured oral presentation at the AACR-NCI-EORTC conference this year," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "The findings continue to suggest RP-3500 may have broad clinical efficacy in tumors with diverse genetic alterations and provides further clinical proof of concept and validation of our SNIPRx platform. We look forward to providing updates in the future on the potential of RP-3500, both as a monotherapy and in combination with PARP inhibitors."
Third Quarter 2021 Review and Operational Updates:
-- Announced initial monotherapy clinical data from Phase 1/2 TRESR study of
RP-3500 in patients with solid tumors at the AACR-NCI-EORTC conference
-- Early data showed RP-3500 appears safe and well tolerated. The
most common treatment emergent adverse events in any of the 101
patients treated, expectedly, was grade 1-2 anemia, with only
21.8% of all patients experiencing Grade 3 anemia (no Grade 4).
There were no discontinuations related to RP-3500 emergent adverse
events and dose interruptions, and reductions or red blood cell
transfusions were infrequent on the recommended 3 days on/4 days
off weekly regimen.
-- 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. This schedule assures repeated weekly
exposure to RP-3500 at an efficacious dose. The Grade 3 anemia
rate at this schedule overall was only 14.5%.
-- Antitumor activity, defined as RECIST based objective responses,
was observed in patients with tumors harboring SNIPRX predicted
genomic alternations at doses >100mg (ATM, CDK12, BRCA1, BRCA2,
RAD51C), across multiple tumor types and included patients after
PARP inhibitor failure. Meaningful clinical benefit was observed
in 49% of 69 patients with available scans. Those include 12
patients with tumor responses per established international
efficacy criteria, 14 patients with ongoing stable disease for at
least 16 weeks and an additional 8 patients with stable disease
who only had two radiological evaluations, but had demonstrated
significant decreases in tumor markers or initial tumor shrinkage
of less than 30%. Promising deep molecular responses in
circulating tumor DNA (ctDNA) for tumors with STEP2 genomic
alterations were observed in a subset of patients available for
serial ctDNA analysis.
-- Final readouts from patients enrolled in the monotherapy arm of
the TRESR trial, as well as initial data from the combination arm
testing RP-3500 together with PARP inhibitors, are expected in
2022.
-- Raised Gross Proceeds of $101.2 Million in Upsized Follow-on Public
Offering
-- In November 2021, the Company announced the closing of an upsized
unwritten follow-on public offering yielding aggregate gross
proceeds of approximately $101.2 million, or net proceeds of
approximately $93.9 million, after deducting underwriting
commissions and estimated offering expenses of $1.2 million
payable by us. All of the shares in the offering were offered by
Repare Therapeutics.
-- Appointed Thomas Civik to Board of Directors as new Chairman
-- In September 2021, the Company appointed Thomas Civik to its Board
of Directors as its Chairman. He replaced Jerel Davis, Ph.D., who
remains a Board member.
-- Mr. Civik was most recently President and CEO of Five Prime
Therapeutics until its $1.9 billion acquisition by Amgen in April
2021. He has over 25 years of leadership and commercial experience
at various companies including Foundation Medicine and Genentech.
-- Achieved $0.9 million (Yen100 million) research trigger pursuant to the
terms of its research services, license and collaboration agreement with
Ono Pharmaceutical Co., Ltd
-- On October 13, 2021, upon the occurrence of a specified research
trigger, the Company became eligible to receive a portion,
amounting to Yen100 million ($0.9 million), of the research
service payments provided for in its research services, license
and collaboration agreement with Ono Pharmaceutical Co., Ltd., or
Ono, ("Ono Agreement") for the research of potential product
candidates targeting Pol . Furthermore, on October 29, the Company
and Ono entered into an amendment to the Ono Agreement whereby the
Research Term, as defined in the Ono Agreement, was extended by
one year.
Third Quarter 2021 Financial Results:
-- Cash and cash equivalents, restricted cash and marketable securities:
Cash and cash equivalents, restricted cash and marketable securities as
of September 30, 2021 were $268.2 million, exclusive of the proceeds from
the follow-on public offering.
-- Research and development expenses, net of tax credits (Net R&D): Net R&D
expenses were $25.4 million and $62.1 million for the three- and
nine-month periods ended September 30, 2021, respectively, as compared to
$10.1 million and $27.7 million for the three- and nine-month periods
ended September 30, 2020, respectively. The increase in R&D expenses for
the three and nine-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 $6.6 million
and $18.6 million for the three and nine-month periods ended September
30, 2021, respectively, as compared to $4.0 million and $9.6 million for
the three and nine-month periods ended September 30, 2020, respectively.
The increase in G&A expenses for the three and six-month periods were due
to personnel related costs, including share-based compensation, and D&O
insurance which increased as a result of the Company's IPO in June 2020.
-- Net loss: Net loss was $30.9 million, or $0.83 per share and $78.6
million, or $2.12 per share, in the three and nine-month periods ended
September 30, 2021, respectively, and $13.8 million, or $0.37 per share
and $38.2 million, or $2.63 per share in the three and nine-month periods
ended September 30, 2020, respectively.
About Repare Therapeutics' SNIPRx(R) Platform
Repare's SNIPRx(R) 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(R) screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.
About Repare Therapeutics, Inc.
Repare Therapeutics is a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx(R) platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company's pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor currently in Phase 1/2 clinical development, its second clinical candidate, RP-6306, a PKMYT1 inhibitor currently in Phase 1 clinical development, a Pol inhibitor program, as well as eight other early-stage, pre-clinical programs. For more information, please visit reparerx.com.
SNIPRx(R) is a registered trademark of Repare Therapeutics Inc.
Forward-Looking Statement