1. 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 provided a corporate update and highlighted key milestones anticipated in 2022.

    "2021 was a substantial year of progress for Repare. We presented encouraging initial Phase 1 RP-3500 monotherapy data from our Phase 1/2 TRESR trial and began enrollment of patients in our combination trials of RP-3500 with PARP inhibitors and with gemcitabine. We also entered the clinic with our second pipeline program, RP-6306, a first-in-class, oral PKMYT1 inhibitor both as monotherapy and in combination with gemcitabine…

    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 provided a corporate update and highlighted key milestones anticipated in 2022.

    "2021 was a substantial year of progress for Repare. We presented encouraging initial Phase 1 RP-3500 monotherapy data from our Phase 1/2 TRESR trial and began enrollment of patients in our combination trials of RP-3500 with PARP inhibitors and with gemcitabine. We also entered the clinic with our second pipeline program, RP-6306, a first-in-class, oral PKMYT1 inhibitor both as monotherapy and in combination with gemcitabine," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "Our successful follow-on public offering in November of last year secured proceeds that enable us to further advance our innovative pipeline of clinical and preclinical programs through 2023. 2022 is expected to be another exciting year for the Company as we look forward to the data from the expansion cohorts of the TRESR trial in tumors with STEP2 genomic alterations alone and in various combinations. We are looking forward to the initial data from the Phase 1 RP-6306 monotherapy MYTHIC trial and data from additional studies of RP-6306 in combination with chemotherapy agents in advanced solid tumors. We are also on track to initiate IND-enabling studies for our Polθ inhibitor program that will further expand our synthetic lethality-based clinical pipeline."

    Key Milestones Anticipated in 2022:

    • Initiation of a monotherapy Phase 2 TRESR trial of RP-3500, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), for the treatment of solid tumors with specific synthetic-lethal genomic alterations including those in the ATM gene (ataxia teleangectasia mutated kinase), in tumors with ATM loss of function and in tumors with other STEP2 genomic alteration is expected in the first quarter of 2022;
    • Initiation of a Phase 1 pediatric module of TRESR trial of RP-3500 monotherapy in children is expected in the first quarter of 2022;
    • Receipt of monotherapy Phase 1 (Module 1) clinical data from 120 patients enrolled in the Phase 1/2 TRESR (Treatment Enabled by SNIPRx) trial of RP-3500 is expected in the first half of 2022;
    • Initiation of IND-enabling studies in the Company's Polθ inhibitor program expected in the first half 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; and
    • Early clinical data readouts for PARPi combination from Phase 1/2 TRESR trial and ATTACC trial of RP-3500 in combination with, collectively, three marketed PARP inhibitors expected in the second half of 2022.

    Cash Position and Financial Guidance

    Repare ended the third quarter of 2021 with approximately $268.2 million in cash and cash equivalents. In November 2021, the Company closed an upsized underwritten 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. The Company expects that its cash and cash equivalents will be sufficient to fund its planned operations through 2023.

    Upcoming Presentation at 40th Annual J.P. Morgan Healthcare Conference

    Repare Therapeutics will present at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 3:45 p.m. Eastern Time. A live webcast of the presentation can be accessed in the Investor section of the Company's website at https://ir.reparerx.com/news-and-events/events. A replay of the webcast will be archived on the Company's website for 30 days.

    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® 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 Polθ inhibitor program, as well as eight other early-stage, pre-clinical programs. For more information, please visit reparerx.com.

    SNIPRx® is a registered trademark of Repare Therapeutics Inc.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are "forward-looking statements. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the clinical development of the Company's pipeline and its research and development programs, including the anticipated design, progress, timing, anticipated patient enrollment, scope, data readouts, trial outcomes or associated costs of its clinical trials of RP-3500 and RP-6306; additional clinical trials based on initial data from trials which may not be may not be indicative of the final results of the clinical trials; the initiation of IND-enabling studies for the Company's Polθ inhibitor program; the determination of recommend Phase 2 doses for its product candidates; the anticipated achievement of upcoming clinical milestones including data readouts from expansion cohorts, the initiation of a Phase 2 TRESR trial of RP-3500 in 2022, the initiation of a Phase 1 pediatric module of TRESR study trial of RP-3500 monotherapy in 2022, and the initiation of a Phase 1 clinical trial of RP-6306 in combination with FOLFIRI in 2022; and anticipated cash runway. These forward-looking statements are based on the Company's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause the Company's clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause the Company's actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 filed with the Securities and Exchange Commission ("SEC") and the Québec Autorité des Marchés Financiers ("AMF") on November 10, 2021, and its other documents subsequently filed with or furnished to the SEC and AMF. The Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

    View Full Article Hide Full Article
  2. Former CCO of Y-mAbs Therapeutics brings 20 years of pharma and biotech commercial leadership 

    Repare Therapeutics Inc. ("Repare" or the "Company") (NASDAQ:RPTX), a leading clinical-stage precision oncology company, today announced the appointment of Philip Herman as its EVP Commercial & New Product Development.

    "We are excited to welcome Phil to Repare as we are looking forward to key catalysts for RP-3500 and RP-6306 in 2022. 2022 will be an important year for us as we continue to build Repare into the leading precision oncology company delivering synthetic lethality medicines that meaningfully improve the lives of cancer patients," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "Phil is an experienced executive…

    Former CCO of Y-mAbs Therapeutics brings 20 years of pharma and biotech commercial leadership 

    Repare Therapeutics Inc. ("Repare" or the "Company") (NASDAQ:RPTX), a leading clinical-stage precision oncology company, today announced the appointment of Philip Herman as its EVP Commercial & New Product Development.

    "We are excited to welcome Phil to Repare as we are looking forward to key catalysts for RP-3500 and RP-6306 in 2022. 2022 will be an important year for us as we continue to build Repare into the leading precision oncology company delivering synthetic lethality medicines that meaningfully improve the lives of cancer patients," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "Phil is an experienced executive who brings to us decades of global oncology experience which will be invaluable as we establish and execute on an integrated product development plan and an eventual commercial launch strategy for the Company."

    "I am thrilled to join Repare at this exciting time in the Company's evolution," said Mr. Herman. "I look forward to contributing my expertise in guiding Repare towards a potential commercial launch and assisting the Company as it begins to transition from a clinical stage company to a commercial organization."

    Mr. Herman joins Repare from Y-mAbs Therapeutics, where he served as Chief Commercial Officer and led the successful launch of DANYELZA® (naxitamab). He brings extensive commercial experience with a focus in oncology and rare diseases and has a proven track record of successful new product launches. He has held several marketing positions including Vice President, Head of Santhera U.S. and Head of Commercial, Head of Marketing at Dyax Corp., Director of Marketing at Vanda Pharmaceuticals, and various commercial positions of increasing responsibility at Pfizer. Mr. Herman received his MBA from the Kellogg School of Management at Northwestern University, and a BA in business administration from Baldwin Wallace University.

    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® 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 Polθ inhibitor program, as well as eight other early-stage, pre-clinical programs. For more information, please visit reparerx.com.

    SNIPRx® is a registered trademark of Repare Therapeutics Inc.

    Forward-Looking Statement

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are "forward-looking statements. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the Company's business strategy and pipeline, the clinical development of the Company's pipeline including the timing of data readouts, regulatory submission and potential commercial launch as well as plans for regulatory approval generally the potential of RP-3500 and RP-6306 to provide for benefits for patients and the Company's plans for transition into a commercial stage company. These forward-looking statements are based on the Company's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause the Company's clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause the Company's actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled "Risk Factors" in the Company's Quarterly Report for the period ended September 30, 2021 filed with the Securities and Exchange Commission ("SEC") on November 10, 2021 and any subsequent filings with the SEC. The Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

    View Full Article Hide Full Article
  3. 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 announced that Lloyd M. Segal, President and Chief Executive Officer, will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 3:45 p.m. Eastern Time.

    A live webcast of the presentation can be accessed in the Investor section of the Company's website at https://ir.reparerx.com/news-and-events/events. A replay of the webcast will be archived on the Company's website for 30 days.

    About Repare Therapeutics, Inc.

    Repare Therapeutics is a leading clinical-stage…

    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 announced that Lloyd M. Segal, President and Chief Executive Officer, will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 3:45 p.m. Eastern Time.

    A live webcast of the presentation can be accessed in the Investor section of the Company's website at https://ir.reparerx.com/news-and-events/events. A replay of the webcast will be archived on the Company's website for 30 days.

    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® 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 Polθ inhibitor program, as well as eight other early-stage, pre-clinical programs. For more information, please visit reparerx.com.

    SNIPRx® is a registered trademark of Repare Therapeutics Inc.

    View Full Article Hide Full Article
  4. Repare Therapeutics Inc. ("Repare" or the "Company") (NASDAQ:RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to discover and develop novel therapeutics, today announced the first patient has been dosed in the Company's 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 (NCT05147272) (the "MAGNETIC" trial).

    "Dosing of the first patient in the Phase 1 RP-6306 trial in combination with gemcitabine, alongside our ongoing monotherapy "MYSTIC" trial, is an exciting milestone for Repare as we continue to advance our unique precision oncology pipeline…

    Repare Therapeutics Inc. ("Repare" or the "Company") (NASDAQ:RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to discover and develop novel therapeutics, today announced the first patient has been dosed in the Company's 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 (NCT05147272) (the "MAGNETIC" trial).

    "Dosing of the first patient in the Phase 1 RP-6306 trial in combination with gemcitabine, alongside our ongoing monotherapy "MYSTIC" trial, is an exciting milestone for Repare as we continue to advance our unique precision oncology pipeline across multiple fronts," said Maria Koehler MD, PhD, Chief Medical Officer of Repare. "MAGNETIC will assess the safety and tolerability of RP-6306 in combination with gemcitabine. It will enroll approximately 104 patients with tumors harboring genomic alterations that were identified through Repare's proprietary STEP2 screens. We look forward to providing updates on RP-6306 later in 2022."

    This multicenter Phase 1 study aims to determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.

    About RP-6306

    RP-6306 is a first-in-class, selective, orally available inhibitor of PKMYT1 that was discovered and developed entirely in-house by Repare. Through Repare's SNIPRx screen campaign for targets that are SL with CCNE1 amplification, the Company identified and validated this novel SL gene that has the characteristics of a therapeutic target. Repare has developed novel and selective inhibitors against PKMYT1, which demonstrated compelling pre-clinical anti-tumor activity alone and in combination with certain anticancer agents, and subsequently announced the advancement of a clinical candidate to this potential, first-in-class program.

    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® 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 Polθ inhibitor program, as well as eight other early-stage, pre-clinical programs. For more information, please visit reparerx.com.

    SNIPRx® is a registered trademark of Repare Therapeutics Inc.

    View Full Article Hide Full Article
  5. 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 announced that each of its: President and Chief Executive Officer, Lloyd Segal; Executive Vice President and Chief Financial Officer, Steve Forte; Executive Vice-President and Chief Scientific Officer, Michael Zinda; Executive Vice-President and Chief Medical Officer, Maria Kohler; Executive Vice-President Discovery, Cameron Black; and Executive Vice President, Head of Business & Corporate Development, Kim Seth (collectively, the "Executives"), as well as certain other insiders of the Company (the "Other Insiders…

    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 announced that each of its: President and Chief Executive Officer, Lloyd Segal; Executive Vice President and Chief Financial Officer, Steve Forte; Executive Vice-President and Chief Scientific Officer, Michael Zinda; Executive Vice-President and Chief Medical Officer, Maria Kohler; Executive Vice-President Discovery, Cameron Black; and Executive Vice President, Head of Business & Corporate Development, Kim Seth (collectively, the "Executives"), as well as certain other insiders of the Company (the "Other Insiders" and collectively with the Executives, the "Participants"), have terminated existing Automatic Securities Disposition Plans ("ASDPs") and established new ASDPs or modified existing ASDPs in accordance with applicable United States and Canadian securities legislation, including the recommended practices set forth in the recently issued Canadian Securities Administrators' Staff Notice 55-317 ("Staff Notice 55-317") and the Company's internal policies.

    While Repare is listed on the Nasdaq Global Select Market, it is also considered a reporting issuer under the Securities Act (Québec) and is therefore announcing the foregoing establishment or amendment of the ASDPs in furtherance of the recently published guidance provided by the Canadian Securities Administrators in Staff Notice 55-317.

    Under U.S. and Canadian securities laws and the Company's trading policies, insiders of Repare are subject to limits on their ability to sell shares in the Company. The ASDPs address this issue by permitting trades to be made in accordance with pre-arranged instructions given when Participants are not in possession of any material undisclosed information.

    Up to 328,681 common shares of Repare may be sold under the ASDPs implemented or modified by the Executives in the aggregate, and up to 95,320 common shares of Repare may be sold under the ASDPs implemented by the Other Insiders. The ASDPs are designed to allow for an orderly disposition of each of the Participants' shares in Repare at prevailing market prices over the course of the 12 to 24 months that the ASDPs are expected to be in place. Sales of the common shares under the ASDPs will only commence after the Company has announced and filed its next annual financial statements for the fiscal year ended December 31, 2021, in accordance with the recent recommended practices set forth in Staff Notice 55-317.

    Each Participant has provided for clear trading parameters and other instructions in writing to the independent dealers administering the ASDPs, specifying the number of securities to be sold and setting out minimum trade prices, which in most cases exceed the current trading price of the Company's common shares, and the dates or frequencies of sales. The ASDPs prohibit the dealer administering the ASDPs from consulting with the Participants regarding any sales under the ASDPs and prohibit the Participants from disclosing to the dealer any information concerning the Company that might influence the execution of the ASDPs

    The ASDPs contain meaningful restrictions on the ability of the Participants to amend, suspend or terminate the ASDPs that have the effect of ensuring that the Participants cannot benefit from material non-public information.

    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® 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 Polθ inhibitor program, as well as eight other early-stage, pre-clinical programs. For more information, please visit reparerx.com.

    SNIPRx® is a registered trademark of Repare Therapeutics Inc.

    View Full Article Hide Full Article