[Form 8-K Current Report](index=1&type=section&id=Form%208-K) [Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02.%20Results%20of%20Operations%20and%20Financial%20Condition.) Repare Therapeutics reported preliminary, unaudited cash, cash equivalents, and marketable securities of approximately $153 million as of December 31, 2024 Preliminary Financial Position | Metric | Value (Preliminary, Unaudited) | | :--- | :--- | | Cash, Cash Equivalents and Marketable Securities | Approx. $153 million | - The announced financial information is **preliminary, unaudited**, and represents a **management estimate**, subject to change upon completion of year-end financial closing procedures[5](index=5&type=chunk) - The company's independent registered public accounting firm has **not audited or reviewed** these preliminary results[5](index=5&type=chunk) [Regulation FD Disclosure](index=2&type=section&id=Item%207.01%20Regulation%20FD%20Disclosure.) The company re-aligned resources to focus on Phase 1 clinical programs RP-1664 and RP-3467, extending cash runway into mid-2027 - Announced a **re-alignment of resources** and **re-prioritization** of its clinical portfolio[8](index=8&type=chunk) - The strategic focus will be on advancing **Phase 1 clinical programs: RP-1664 and RP-3467**[8](index=8&type=chunk) - Planned **cost savings** and **headcount reductions** are projected to extend the company's **cash runway into mid-2027**[8](index=8&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=2&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) Forward-looking statements on business plans and cash runway are subject to risks and uncertainties, potentially causing actual results to differ - The report includes **forward-looking statements** regarding **business plans**, expected **cost-savings**, and the estimated **cash runway**[10](index=10&type=chunk) - These statements are **not guarantees of future performance** and are subject to **risks and uncertainties** that could cause actual results to **differ materially**[10](index=10&type=chunk) - Identified risks include the successful implementation of **cost-cutting**, the impact on business and **employee retention**, and potential **litigation or regulatory actions**[10](index=10&type=chunk) [Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits.) This section lists exhibits filed with the Form 8-K, including a press release dated January 9, 2025 Filed Exhibits | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release dated January 9, 2025 | | 104 | Cover Page Interactive Data File |

Core Insights - Repare Therapeutics Inc has released data from its MYTHIC Phase 1 trial evaluating the combination therapy of lunresertib and camonsertib for endometrial cancer and platinum-resistant ovarian cancer [1] Group 1: Clinical Findings - In the gynecologic cancer expansion cohort, 51 evaluable patients were enrolled as of the data cut-off date of November 14 [1] - For endometrial cancer, the overall response rate was 25.9%, with clinical benefit observed in 48.1% of patients, and a 24-week progression-free survival (PFS) rate of 43% [4] - In platinum-resistant ovarian cancer, the overall response rate was 37.5%, with clinical benefit in 79% of patients, and a 24-week PFS rate of 45% [5] Group 2: Safety Profile - Lunre+Camo therapy demonstrated a favorable tolerability profile compared to current and emerging therapies, with the most common adverse event being anemia at 26.9% (Grade 3) [2][3] Group 3: Regulatory and Development Plans - Repare has consulted with the FDA and the European Medicines Agency regarding registrational development plans for Lunre+Camo in gynecologic tumors [5] - The company plans to submit final Phase 3 trial protocols for regulatory clearance soon and aims to start the first Phase 3 trial in endometrial cancer in the second half of 2025 [6] Group 4: Market Reaction - Following the announcement, RPTX stock experienced a decline of 52.4%, trading at $1.89 [7]

Clinical Development - The company is a leading clinical-stage precision oncology firm utilizing a proprietary synthetic lethality approach for drug development [70]. - The company has developed four clinical therapeutic candidates, including Lunresertib, which is currently the only PKMYT1 inhibitor in clinical trials [71]. - Positive initial Phase 1 data for Lunresertib was presented, showing it to be well tolerated with a compelling safety profile [72]. - The company expects to provide updated MYTHIC data from endometrial cancer expansion cohorts in December 2024, with a registrational trial anticipated to start in 2025 [73]. - The first patient was dosed in the LIONS clinical trial for RP-1664 in February 2024, with plans to move into a Phase 1/2 trial for pediatric neuroblastoma [76]. - Initial data for RP-3467 demonstrated complete, sustained regressions in combination with PARP inhibitors, with the first patient dosed in the POLAR Phase 1 trial in October 2024 [77]. - The company is evaluating lunresertib in combination with camonsertib in a clinical trial, with data expected from approximately 20-30 patients in December 2024 [78]. - Initial data from the TRESR clinical trial evaluating camonsertib in NSCLC is expected to be reported in 2025 [80]. - The POLAR clinical trial for RP-3467 has commenced, evaluating its safety and preliminary clinical activity in advanced solid tumors [82]. Financial Performance - The company reported net losses of $93.8 million for the year ended December 31, 2023, and an accumulated deficit of $389.1 million as of September 30, 2024 [86]. - Revenue from collaboration agreements totaled $53.5 million for the nine months ended September 30, 2024, compared to $38.1 million for the same period in 2023 [95]. - The company received a $40 million milestone payment from Roche in February 2024 upon dosing the first patient with camonsertib in Roche's Phase 2 TAPISTRY trial [97]. - Revenue for the three months ended September 30, 2024, was nil, a decrease of $2.2 million compared to $2.2 million for the same period in 2023, primarily due to the termination of the Roche Agreement and expiration of the BMS Agreement [125]. - Revenue for the nine months ended September 30, 2024, was $53.5 million, an increase of $15.4 million compared to $38.1 million for the same period in 2023, driven by a milestone achievement under the Roche Agreement [132]. - The company reported a net loss of $56.0 million for the nine months ended September 30, 2024, compared to a net loss of $65.8 million for the same period in 2023 [150][152]. Research and Development Expenses - Total research and development costs for the nine months ended September 30, 2024, amounted to $91.446 million, compared to $98.327 million for the same period in 2023, reflecting a decrease [114]. - Research and development expenses for the three months ended September 30, 2024, were $28.4 million, down from $32.7 million in 2023, a decrease of $4.3 million attributed to reduced external costs and personnel-related costs [126]. - Research and development expenses for the nine months ended September 30, 2024, were $91.4 million, down from $98.3 million in 2023, a decrease of $6.9 million due to various program cost adjustments [134]. - The company plans to substantially increase research and development expenses in the long term, particularly for the potential registrational trial of lunresertib and camonsertib combination expected to commence in 2025 [116]. Cash and Funding - As of September 30, 2024, the company had cash and cash equivalents and marketable securities of $179.4 million, expected to fund operations into the second half of 2026 [85]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $49.1 million, a decrease of $49.9 million compared to $99.0 million for the same period in 2023 [149][150][152]. - Cash provided by operating activities increased by $49.9 million primarily due to a $40.0 million milestone payment from Roche in Q1 2024 [153]. - The company has a cash balance of $179.4 million as of September 30, 2024, with $8.4 million earned in interest income during the same period [161]. - The company expects to finance its cash needs through equity offerings, debt financings, and collaborations, which may dilute shareholder ownership [148]. Workforce and Restructuring - The company has reduced its workforce by approximately 25% as part of a strategic reprioritization of R&D activities [83]. - The company incurred approximately $1.5 million in restructuring expenses due to a strategic reprioritization of research and development activities, resulting in a 25% workforce reduction [120]. - Restructuring expenses of $1.5 million were incurred in the three months ended September 30, 2024, as part of a strategic refocus [128]. Agreements and Collaborations - The company received a cumulative total of $182.6 million from Roche for the camonsertib collaboration, which included an initial $125 million upfront payment [73]. - The Roche Agreement was terminated on May 7, 2024, allowing the company to regain global development and commercialization rights for camonsertib [99]. - The company recognized approximately $10.5 million as revenue for the three and six months ended June 30, 2023, under the Ono Agreement, which has since concluded [104]. - The company recognized $2.6 million as revenue related to undruggable targets, including an option fee payment of $0.1 million, following the exercise of an option by Bristol-Myers Squibb [103]. - The company is eligible to receive up to $301.0 million in total milestones on a program-by-program basis, contingent upon achieving specified research, development, regulatory, and commercial milestones [102].

Clinical Trials - The company is on track to report data from the MYTHIC dose expansion clinical trial in December 2024, with plans to begin a registrational trial in 2025[1] - The first patient has been dosed in the Phase 1 POLAR trial evaluating RP-3467, a Polq ATPase inhibitor, alone and in combination with the PARP inhibitor, olaparib[1] - The company presented positive updated safety and tolerability data from the Phase 1 MYTHIC trial, showing a reduction in Grade 3 anemia to 22.6% from 51.4%[4] Financial Performance - Cash, cash equivalents, and marketable securities as of September 30, 2024, were $179.4 million, sufficient to fund operations into the second half of 2026[11] - Revenue from collaboration agreements was nil for the three months ended September 30, 2024, compared to $2.2 million for the same period in 2023[12] - Net R&D expenses were $28.4 million for the three months ended September 30, 2024, down from $32.7 million for the same period in 2023[13] - General and administrative expenses were $6.4 million for the three months ended September 30, 2024, compared to $7.9 million for the same period in 2023[14] - The net loss for the three months ended September 30, 2024, was $34.4 million, or $0.81 per share, compared to a net loss of $18.9 million, or $0.45 per share, for the same period in 2023[15] - Total operating expenses for Q3 2024 were $36,372,000, down from $40,577,000 in Q3 2023, a decrease of 5.4%[20] - Net loss for Q3 2024 was $34,406,000, compared to a net loss of $18,879,000 in Q3 2023, an increase of 82.7%[20] - Research and development expenses for the nine months ended September 2024 were $91,446,000, down from $98,327,000 for the same period in 2023, a decrease of 7%[20] - General and administrative expenses for Q3 2024 were $6,444,000, a decrease of 18.1% from $7,868,000 in Q3 2023[20] - Interest income for Q3 2024 was $2,512,000, compared to $3,312,000 in Q3 2023, a decrease of 24.1%[20] - Comprehensive loss for Q3 2024 was $34,132,000, compared to $18,707,000 in Q3 2023, an increase of 82.5%[20] - Net loss per share attributable to common shareholders for Q3 2024 was $(0.81), compared to $(0.45) in Q3 2023, a decrease of 80%[20] - Total other income for Q3 2024 was $2,451,000, down from $3,240,000 in Q3 2023, a decrease of 24.4%[20] - Restructuring expenses for Q3 2024 were $1,527,000, with no restructuring expenses reported in Q3 2023[20] Workforce and Strategic Changes - The company reduced its overall workforce by approximately 25% as part of a strategic reprioritization of its R&D activities[10] - Total assets as of September 30, 2024, were $206.4 million, down from $253.9 million as of December 31, 2023[19]

Core Insights - Repare Therapeutics (RPTX) shares increased by 8% following the announcement of dosing the first patient in an early-stage study for the combination of RP-3467 and AstraZeneca's Lynparza to treat advanced solid tumors [1] - The combination of RP-3467 and Lynparza has shown promising preclinical results, leading to complete and durable tumor regressions without additional toxicities, indicating potential to improve patient outcomes by addressing PARP inhibitor resistance [2] - The ongoing phase I POLAR study aims to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-3467, targeting 52 patients with specific advanced solid tumors [3][4] Company Pipeline - Repare utilizes its CRISPR-enabled SNIPRx platform to develop targeted cancer therapies focusing on genomic instability and DNA damage repair [5] - The company is also evaluating lunresertib, a PKMYT1 inhibitor, in combination with camonsertib, an ATR inhibitor, in a phase I study for ovarian and endometrial cancer, with top-line data expected soon [6] - RP-1664, an oral PLK4 inhibitor, is currently in a phase I study for advanced solid tumors, indicating a diverse clinical-stage pipeline [7] Market Context - Year to date, RPTX shares have decreased by 53.6%, contrasting with a 2% decline in the broader industry [3] - Repare currently holds a Zacks Rank 3 (Hold), while ANI Pharmaceuticals and Alnylam Pharmaceuticals are ranked 1 (Strong Buy) [8]

Core Viewpoint - Repare Therapeutics is approaching a significant milestone with the upcoming results from its phase 1 MYTHIC trial, which is testing the combination of lunresertib and camonsertib for treating platinum-resistant ovarian and endometrial cancers. The data expected in Q4 2024 will be crucial in determining the viability of its SNIPRx platform for developing Synthetic Lethality drugs [2][3]. Company Overview - Repare Therapeutics is focused on developing lunresertib in combination with camonsertib for patients with specific genetic mutations in platinum-resistant ovarian and endometrial cancers. The MYTHIC trial is currently ongoing to evaluate this combination [3]. - The global ovarian cancer market is projected to reach $11.18 billion by 2029, indicating a substantial market opportunity for effective treatments targeting this disease [3]. Clinical Trials and Data - The MYTHIC trial aims to assess the efficacy of lunresertib and camonsertib in a patient population with genetic alterations. Data from 20 to 30 patients is expected to be released in Q4 2024 [3]. - Preliminary results from a cohort of 26 pre-treated gynecologic cancer patients showed an objective response rate of 38.5% and a clinical benefit rate of 57.7% when treated with lunresertib and camonsertib [3]. Financials - As of June 30, 2024, Repare Therapeutics reported cash, cash equivalents, and marketable securities totaling $208.1 million. The company anticipates its cash runway to extend into the second half of 2026 due to a strategic reprioritization of its pipeline and a reduction in workforce by 25% [4][5]. Strategic Focus - The company is narrowing its pipeline to focus on lunresertib, camonsertib, RP-1664, and RP-3467, while reducing preclinical research and discovery activities. This strategic shift is expected to yield annual savings of $15 million [5]. Future Catalysts - The next significant catalyst for Repare Therapeutics will be the data release from the MYTHIC trial in Q4 2024. If the results are positive, it could lead to the initiation of a phase 3 study in 2025 targeting patients with genomic alterations [7]. - Additionally, the company is exploring other opportunities, including a monotherapy program for camonsertib in non-small cell lung cancer, with initial results expected in 2025 [7].

Repare Therapeutics Inc. (RPTX) came out with a quarterly loss of $0.82 per share versus the Zacks Consensus Estimate of a loss of $0.85. This compares to loss of $0.28 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 3.53%. A quarter ago, it was expected that this company would post a loss of $0.10 per share when it actually produced earnings of $0.30, delivering a surprise of 400%. Over the last four quarters, the company ha ...

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 Repare Therapeutics Inc. (Exact Name of Registrant as Specified in its Charter) Québec Not applicable (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) St-Laurent, Québec, Canada H4S 1Z9 (Address of principal executive offices) (Zip Co ...

Exhibit 99.1 Repare Therapeutics Provides Business and Clinical Update and Reports First Quarter 2024 Financial Results Phase 1 MYTHIC clinical trial of lunresertib in combination with camonsertib demonstrated a significant reduction in Grade 3 anemia and continued trends of patient response and benefit; FDA agrees with RP2D First patient dosed in Phase 1 MYTHIC clinical trial of lunresertib in combination with the WEE1 inhibitor, Debio 0123; first clinical trial inhibiting both PKMYT1 and WEE1 Initiating P ...