On March 3, 2025 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Repare Therapeutics, MAR 3, 2025, View Source [SID1234650839]).

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"Our recently implemented re-structuring and the re-prioritization of our clinical portfolio meaningfully extends our cash runway into late 2027. We are now focused on three ongoing Phase 1 clinical trials with readouts expected in 2025: the LIONS trial evaluating our RP-1664 PLK4 inhibitor; the POLAR trial evaluating our RP-3467 Polθ ATPase inhibitor; and our ongoing MYTHIC trial evaluating lunresertib in combination with Debiopharm’s WEE1 inhibitor, Debio 0123," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "Our progress with RP-3467 Polθi is particularly promising. We believe we are leading the field with helicase Polθi – PARPi clinical combinations and look forward to sharing initial data by Q3 this year."

Fourth Quarter 2024 and Recent Portfolio Highlights:

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RP-3467: Potential best-in-class, oral Polθ ATPase/helicase inhibitor
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Repare initiated the Phase 1 clinical trial of RP-3467 (POLAR) in the fourth quarter of 2024, dosing patients alone and in combination with the poly-ADP ribose polymerase (PARP) inhibitor, olaparib. The POLAR clinical trial is a multicenter, open-label, dose-escalation Phase 1 clinical trial designed to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-3647 alone or in combination with olaparib in adults with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma.
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Upcoming expected milestones:
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Q3 2025: Topline safety, tolerability and early efficacy data from the POLAR trial in monotherapy and in combination with olaparib.
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RP-1664: First-in-class, oral selective PLK4 inhibitor
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Repare is currently evaluating RP-1664 as a monotherapy in the Phase 1 LIONS clinical trial in adult and adolescent patients with TRIM37-high solid tumors. The LIONS clinical trial is a first-in-human,

multicenter, open-label Phase 1 clinical trial designed to investigate safety, pharmacokinetics, pharmacodynamics and the preliminary efficacy of RP-1664.
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Upcoming expected milestones:
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Q3 2025: Initiation of a Phase 1/2 expansion trial in pediatric neuroblastoma
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Q4 2025: Initial topline safety, tolerability and early efficacy data from the LIONS trial
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Mid-2026: Trial completion and final trial readout of proof-of-concept from the LIONS trial
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Lunresertib (RP-6306) in combination with Debio 0123
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Repare is evaluating lunresertib in combination with Debio 0123, a highly selective brain-penetrant, clinical WEE1 inhibitor, in patients with advanced solid tumors harboring CCNE1 amplification or FBXW7 or PPP2R1A deleterious alterations as part of an ongoing 50/50, cost-sharing collaboration with Debiopharm.
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Upcoming expected milestones:
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Q2 2025: Enrollment completion of MYTHIC trial evaluating lunresertib in combination with DEBIO 0123 (WEE1 inhibitor).
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Lunresertib (RP-6306) and Camonsertib (RP-3500)
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Repare reported positive efficacy and safety data from the Phase 1 MYTHIC gynecologic expansion clinical trial evaluating the combination of lunresertib and camonsertib (Lunre+Camo) at the recommended Phase 2 dose (RP2D) in patients with endometrial cancer (EC) and platinum-resistant ovarian cancer (PROC) in December 2024. Nearly half of patients with gynecologic cancers in the trial maintained progression-free survival (PFS) at 24 weeks, comparing favorably to PFS for current standard of care. Repare intends to seek partnering opportunities for this program as a condition to further advancement of the program into pivotal development and will not continue to develop lunresertib or camonsertib in other studies.
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Other Highlights
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Repare announced a re-alignment of resources and a re-prioritization of its clinical portfolio to focus on the continued advancement of its Phase 1 clinical programs, RP-1664 and RP-3467. In connection with the re-alignment, the Company is reducing its workforce by approximately 75% to extend its cash runway into late-2027.
Fourth Quarter and Full Year 2024 Financial Results:

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Cash, cash equivalents and marketable securities: Cash, cash equivalents and marketable securities as of December 31, 2024 were $152.8 million, as compared to $223.6 million as of December 31, 2023. The Company believes that its cash, cash equivalents, and marketable securities, along with the expected cost-savings from the re-alignment, are sufficient to fund its current operational plans into late-2027.
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Revenue from collaboration agreements: Revenue from collaboration agreements was nil and $53.5 million for the three- and twelve-month periods ended December 31, 2024, respectively, as compared to $13.0 million and $51.1 million for the three- and twelve-month periods ended December 31, 2023, respectively.

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Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $24.5 million and $115.9 million for the three- and twelve-month periods ended December 31, 2024, respectively, as compared to $35.3 million and $133.6 million for the three- and twelve-month periods ended December 31, 2023, respectively.
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General and administrative (G&A) expenses: G&A expenses were $6.3 million and $29.7 million for the three- and twelve-month periods ended December 31, 2024, respectively, as compared to $8.6 million and $33.8 million for the three- and twelve-month periods ended December 31, 2023, respectively.
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Net loss: Net loss was $28.7 million, or $0.67 per share, and $84.7 million, or $2.00 per share, in the three- and twelve-month periods ended December 31, 2024, respectively, and $28.0 million, or $0.67 per share, and $93.8 million, or $2.23 per share, in the three- and twelve-month periods ended December 31, 2023, respectively.

On March 3, 2025 Quanterix Corporation (NASDAQ: QTRX) ("Quanterix" or the "Company"), a company fueling scientific discovery through ultra-sensitive biomarker detection, reported the strategic and financial benefits of its proposed acquisition of Akoya Biosciences, which will create the first integrated solution for ultra-sensitive detection of blood- and tissue-based protein biomarkers (Press release, Quanterix, MAR 3, 2025, View Source [SID1234650838]).

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Quanterix’s proposed acquisition of Akoya is the result of a rigorous and thorough Board evaluation consistent with its commitment to position the Company for long-term growth. With enhanced scale and a strengthened financial foundation, Quanterix will accelerate the execution of its strategic plan and deliver significant value to shareholders:

•Expanded Addressable Market. The addition of Akoya’s cutting-edge spatial biology capabilities will unlock a high-growth $5 billion serviceable addressable market across neurology, immunology and oncology, with an additional $10 billion market opportunity in Alzheimer’s Disease diagnostics. By combining Quanterix’s leading position in ultrasensitive detection of proteins in blood and Akoya’s leading position in biomarker detection in tissue, Quanterix will be uniquely positioned to speed up development of new liquid biopsy tests, a market which it believes will surpass that of all other diagnostic tests combined.

•Synergy Generation: With extensive diligence and deep familiarity with Akoya’s platform, Quanterix has clear line of sight to capture approximately $40 million in annual run-rate cost synergies by the end of 2026, $20 million of which is expected to be realized within the first year following close.

•Enhanced Scale and Profitability: With expected positive free cash flow in 2026 and continued strong double-digit organic revenue growth, Quanterix expects the transaction will allow it to multiply its revenue to approximately $1 billion with EBIT margins of approximately 15% within five years following close.

Kent Lake Nominations

Quanterix confirmed that Kent Lake PR LLC ("Kent Lake") has submitted notice nominating three candidates to stand for election to the Quanterix Board of Directors at the Company’s 2025 Annual Meeting of Shareholders.

The Company welcomes engagement with its shareholders and has attempted to engage constructively with Kent Lake and will continue to do so. Kent Lake’s recent statements, however, contain significantly flawed financial assumptions, factually inaccurate information and fail to recognize the compelling and strategically necessary rationale of the transaction. Kent Lake’s director nominations are a clear attempt to obfuscate the long-term value creation opportunity the acquisition of Akoya presents.

The Quanterix Board has been built thoughtfully to ensure that it is composed of directors with outstanding track records and the right mix of skillsets to successfully oversee the Company’s strategic plan, which includes deep expertise across the life sciences industry with a particular focus on diagnostics, as well as commercial strategy, strategic planning, corporate governance and capital markets experience.

The Quanterix Board will evaluate Kent Lake’s nomination notice and present its recommendation with respect to the election of directors in the Company’s proxy statement, which will be filed with the Securities and Exchange Commission ("SEC") and mailed to all shareholders eligible to vote at the 2025 Annual Meeting. The date of the 2025 Annual Meeting has not yet been announced. Quanterix shareholders are not required to take any action with respect to the election of directors at this time.

Quanterix and Akoya are progressing toward closing. On February 13, 2025, Quanterix filed a registration statement on Form S-4, which contains a preliminary joint proxy statement of Quanterix and Akoya and a preliminary prospectus of Quanterix, with the SEC. The transaction is expected to close in the second quarter of 2025, subject to applicable approvals by both companies’ shareholders and satisfaction of other customary closing conditions.

Goldman Sachs & Co. LLC is serving as financial advisor to Quanterix and Covington & Burling LLP is serving as its legal counsel in Quanterix’s acquisition of Akoya.

On March 3, 2025 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, reported a corporate update and reported fourth quarter 2024 financial results (Press release, Pliant Therapeutics, MAR 3, 2025, View Source [SID1234650837]).

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Fourth Quarter and Recent Highlights
Bexotegrast Highlights
•BEACON-IPF discontinued following recommendation from expanded data safety monitoring board (DSMB). Following a prespecified data review and recommendation by the trial’s independent DSMB, as well as a secondary review and recommendation by an outside expert panel, Pliant has discontinued the BEACON-IPF Phase 2b trial. While an imbalance in unadjudicated IPF-related adverse events between the treatment and placebo groups led to the discontinuation of the trial, early evidence of efficacy on the forced vital capacity (FVC) endpoint was also observed. The Company plans to analyze the complete data from the BEACON-IPF trial and evaluate next steps for bexotegrast’s development. BEACON-IPF is a 52-week, multinational, randomized, dose-ranging, double-blind, placebo-controlled trial evaluating bexotegrast at once-daily doses of 160 mg or 320 mg in patients with idiopathic pulmonary fibrosis (IPF).

Oncology Program
•Phase 1 trial of PLN-101095 in solid tumors continues to enroll, with interim data expected in the first quarter 2025. This is a Phase 1 open label trial of PLN-101095, an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment. The trial is currently dosing the fourth of five planned dose cohorts in a Phase 1 open label dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. Interim data from the first three cohorts is expected in the first quarter of 2025.

Neuromuscular Program
•PLN-101325 for treatment of muscular dystrophies. PLN-101325 is a monoclonal antibody that acts as an allosteric agonist of integrin α7β1, currently in development for treatment of muscular dystrophies. PLN-101325 is Phase 1 ready with clinical trial approval (CTA) open in Australia.

Corporate Highlights
•Appointment of Delphine Imbert, Ph.D. as Chief Technical Officer. Dr. Imbert brings 25 years of product development, process optimization and manufacturing experience across multiple drug modalities. Most recently, Dr. Imbert served as Senior Vice President of CMC and Technical Operations at Chinook Therapeutics.

Fourth Quarter 2024 Financial Results
•Research and development expenses were $38.8 million, as compared to $33.2 million for the prior-year quarter. The increase was primarily due to costs associated with the BEACON-IPF Phase 2b/3 clinical trial.
•General and administrative expenses were $14.5 million, as compared to $13.9 million for the prior-year quarter. The increase was primarily due to employee-related expenses driven by increased headcount over prior year.

•Net loss was $49.7 million as compared to $41.1 million for the prior-year quarter. The increase was due to higher operating expenses primarily attributable to costs associated with the BEACON-IPF Phase 2b/3 clinical trial and reduced interest income on short-term investments.
•As of December 31, 2024, the Company had cash, cash equivalents, restricted cash and short-term investments of $357.2 million which the Company expects to be sufficient to fund operations for the next 12 months and beyond.

On March 3, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported a business update and reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Mersana Therapeutics, MAR 3, 2025, View Source [SID1234650836]).

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"We made significant progress advancing the clinical development of Emi-Le in 2024," said Martin Huber, M.D., President and Chief Executive Officer of Mersana Therapeutics. "These efforts enabled us to begin 2025 by announcing positive initial Phase 1 clinical data, the initiation of expansion and a Fast Track designation for HER2-negative breast cancer patients who have previously been treated with at least one topo-1 ADC. With promising monotherapy activity reported in patients across multiple tumors, including those with heavily pretreated triple-negative breast cancer, as well as a differentiated tolerability profile that may enable combination approaches, we believe Emi-Le offers us unique development opportunities that are unavailable to other B7-H4 ADCs."

Emiltatug Ledadotin (Emi-Le; XMT-1660)
In January 2025, Mersana announced positive initial Phase 1 clinical data for Emi-Le, the company’s lead Dolasynthen ADC candidate targeting B7-H4, from 130 patients who were enrolled in dose escalation and backfill cohorts as of a December 13, 2024 data cutoff. The company also announced that Emi-Le had received a second Fast Track designation from the U.S. Food and Drug Administration (FDA).

The expansion portion of the company’s Phase 1 clinical trial continues at a dose of 67.4 mg/m² administered every four weeks in patients with TNBC who had received one to four prior lines of therapy, including at least one topo-1 ADC. In parallel, the company continues to explore higher doses in dose escalation and backfill cohorts to identify a second dose for expansion.

In 2025, Mersana plans to initiate expansion enrollment at a second dose in patients with TNBC who have received one to four prior lines of treatment, including at least one prior topo-1 ADC. The company also plans to present additional Phase 1 clinical data from dose escalation and backfill cohorts in 2025.

XMT-2056
Mersana has continued to advance the dose escalation portion of its Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen ADC candidate targeting a novel HER2 epitope. GSK plc has an exclusive global license option to co-develop and commercialize XMT-2056. Mersana plans to continue enrolling patients in dose escalation and expects to present initial clinical pharmacodynamic STING activation data for XMT-2056 in 2025.

Collaborations
Mersana continues to advance its collaborations with both Johnson & Johnson (Dolasynthen research collaboration) and Merck KGaA, Darmstadt, Germany (Immunosynthen research collaboration).

Fourth Quarter 2024 Financial Results

Cash, cash equivalents and marketable securities as of December 31, 2024 were $134.6 million. Mersana continues to expect that its capital resources will be sufficient to support its current operating plan commitments into 2026.
Net cash used in operating activities for the fourth quarter of 2024 was $19.3 million.
Collaboration revenue for the fourth quarter of 2024 was $16.4 million, compared to $10.7 million for the same period in 2023. The year-over-year change was primarily related to increased collaboration revenue recognized under Mersana’s collaboration and license agreements with Johnson & Johnson, Merck KGaA, Darmstadt, Germany and GSK.
Research and development (R&D) expenses for the fourth quarter of 2024 were $22.3 million, compared to $21.5 million for the same period in 2023. Included in the fourth quarter of 2024 R&D expenses were $1.7 million in non-cash stock-based compensation expenses. The year-over-year increase in R&D expenses was primarily related to increased costs associated with manufacturing and clinical development activities for Emi-Le and XMT-2056, primarily offset by reduced costs related to clinical development activities for UpRi, a discontinued ADC candidate.
General and administrative (G&A) expenses for the fourth quarter of 2024 were $8.9 million, compared to $10.1 million during the same period in 2023. Included in the fourth quarter of 2024 G&A expenses were $1.7 million in non-cash stock-based compensation expenses. The year-over-year decline in G&A expenses was primarily related to reduced employee compensation expense following the company’s 2023 restructuring and reduced consulting and professional services fees.
Net loss for the fourth quarter of 2024 was $14.1 million, or $0.11 per share, compared to a net loss of $19.5 million, or $0.16 per share, for the same period in 2023.
Full Year 2024 Financial Results

Net cash used in operating activities for full year 2024 was $82.3 million.
Collaboration revenue for full year 2024 was $40.5 million, compared to $36.9 million for 2023. The year-over-year increase was primarily related to incremental milestone payments associated with the company’s Johnson and Johnson collaboration and license agreement.

R&D expenses for full year 2024 were $73.0 million, compared to $148.3 million for the full year 2023. Included in 2024 R&D expenses were $8.9 million in non-cash stock-based compensation expenses. The decline in R&D expenses was primarily related to reduced costs associated with manufacturing and clinical development activities for UpRi, reduced employee compensation expenses following the company’s restructuring in 2023, and reduced consulting and professional services fees, partially offset by increased costs for clinical development activities for Emi-Le.
G&A expenses for full year 2024 were $40.8 million, compared to $59.5 million for the full year 2023. Included in 2024 G&A expenses were $7.6 million in non-cash stock-based compensation expenses. The year-over-year decline in G&A expenses was primarily related to reduced consulting and professional services fees and reduced employee compensation expense following the aforementioned restructuring.
Net loss for full year 2024 was $69.2 million, or $0.56 per share, compared to a net loss of $171.7 million, or $1.48 per share, for the full year 2023.

Conference Call Reminder

Mersana will host a conference call today at 8:00 a.m. ET to discuss business updates and its financial results for the fourth quarter and full year of 2024. To access the call, please dial 833-255-2826 (domestic) or 412-317-0689 (international). A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for approximately 90 days.

On March 3, 2025 Intra-Cellular Therapies, Inc. ( the "Company") reported that as previously announced, on January 10, 2025, it has entered into an Agreement and Plan of Merger (the "Merger Agreement") with Johnson & Johnson, a New Jersey corporation ("Parent"), and Fleming Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Parent ("Merger Sub"), pursuant to which, subject to the terms and conditions thereof, Merger Sub will merge with and into the Company (the "Merger"), with the Company surviving the Merger as a wholly owned subsidiary of Parent (Filing, 8-K, Intra-Cellular Therapies, MAR 3, 2025, View Source [SID1234650831]). Capitalized terms used herein and not otherwise defined herein have the meanings set forth in the Merger Agreement.

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The closing of the Merger is conditioned upon, among other things, the expiration or termination of the waiting period applicable to the Merger under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"). The required waiting period under the HSR Act with respect to the Merger expired at 11:59 p.m., Eastern Time on February 26, 2025.

The expiration of the waiting period under the HSR Act satisfies one of the conditions to the closing of the Merger. The closing of the Merger remains subject to the satisfaction or waiver of other customary closing conditions, including, without limitation, the adoption of the Merger Agreement and approval of the Merger by the affirmative vote of the holders of a majority of the outstanding Company Shares. As previously disclosed, the Company has scheduled the special meeting of stockholders for March 27, 2025 to vote on the adoption of the Merger Agreement and approval of the Merger.

For more information about the proposed transaction, including the Merger Agreement, the Merger and the special meeting of the Company’s stockholders, please see the definitive proxy statement filed with the Securities and Exchange Commission (the "SEC") by the Company on February 18, 2025 (the "Definitive Proxy Statement").