On November 6, 2025 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, reported third quarter 2025 financial results and corporate updates.

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"We are pleased with the clinical progress we’ve made across all three of our RLY-2608 trials in breast cancer and vascular malformations," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "In conjunction with our company’s focus on clinical execution, we are pleased to welcome to our Board, Mr. Coats and Mr. Dable, whose extensive experiences in late-stage development and commercialization will help to guide us as we advance our programs."

Board of Directors Updates

Effective November 4, 2025, Lonnel Coats and Habib Dable were appointed to Relay Therapeutics’ Board of Directors.

Lonnel Coats is the former Chief Executive Officer and director of Lexicon Pharmaceuticals, Inc., a biopharmaceutical company. Prior to his time at Lexicon, from 1996 to 2014, Mr. Coats served in a series of leadership positions at Eisai Inc. and Eisai Corporation of North America, U.S. subsidiaries of Tokyo-based Eisai Co., Ltd., a Japanese pharmaceutical company, including as Chief Executive Officer of Eisai Inc. from 2010 to 2014 and as President and Chief Operating Officer of Eisai Inc. from 2004 to 2010. As President and Chief Executive Officer of Eisai, Mr. Coats oversaw the commercialization of Eisai products in the therapeutic areas of oncology, neurology, gastro-intestinal, epilepsy and metabolic disorders. Prior to joining Eisai, Mr. Coats spent eight years with Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, where he held a variety of management and sales positions. Mr. Coats is a former member of the board of directors of Blueprint Medicines and Verve Therapeutics. Mr. Coats holds a B.S. in Public Administration from Oakland University.

Habib Dable has over 30 years of experience in the healthcare industry and is currently an advisor at RA Capital Management, L.P. Most recently, Mr. Dable was President and Chief Executive Officer of Acceleron Pharma Inc., a biopharmaceutical company targeting leading-edge therapies for patients with serious and rare diseases, until its acquisition by Merck in 2021. Prior to joining Acceleron in 2016, Mr. Dable spent 22 years at Bayer AG where he served as President of U.S. Pharmaceuticals; Executive Vice President, Global Head Specialty Medicine; Vice President, Ophthalmology; Global Launch Team Head, EYLEA; Global Head, Neurology and Ophthalmology; and Vice President, Regional Head, Hematology

and Cardiology. He also serves on the board of directors of Day One Biopharmaceuticals, PepGen Inc. and BioLink.org. Mr. Dable is also a former member of the board of directors of Blueprint Medicines, Millendo Therapeutics, Aerovate Therapeutics and Albireo Pharma. Mr. Dable received a B.B.A and M.B.A. from the University of New Brunswick.

RLY-2608 Highlights

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Breast Cancer Clinical Trial Execution
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Continued Phase 3 ReDiscover-2 trial of RLY-2608 + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer
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Continued Phase 1/2 ReDiscover trial, advancing the ongoing triplet cohorts with RLY-2608 + fulvestrant + atirmociclib, palbociclib, or ribociclib
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Vascular Malformations Clinical Trial
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Continued execution of ongoing Phase 1/2 ReInspire clinical trial in vascular malformations

Third Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2025, cash, cash equivalents and investments totaled $596.4 million, as compared to $781.3 million as of December 31, 2024. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.

R&D Expenses: Research and development expenses were $68.3 million for the third quarter of 2025, as compared to $76.6 million for the third quarter of 2024. The decrease of $8.4 million was primarily due to the series of strategic choices made to streamline the research organization throughout 2024 and 2025, as well as cost avoidance on continued development of lirafugratinib after execution of the license agreement with Elevar Therapeutics, Inc. in December 2024, offset by increases in costs for the ReDiscover-2 Trial and ReInspire Trial.

G&A Expenses: General and administrative expenses were $12.1 million for the third quarter of 2025, as compared to $19.8 million for the third quarter of 2024. The decrease of $7.6 million was primarily due to a decrease in stock compensation expense, as well as other employee compensation costs.

Net Loss: Net loss was $74.1 million for the third quarter of 2025, or a net loss per share of $0.43, as compared to a net loss of $88.1 million for the third quarter of 2024, or a net loss per share of $0.63.

(Press release, Relay Therapeutics, NOV 6, 2025, View Source [SID1234659588])

On November 6, 2025 Eilean Therapeutics LLC, a biotechnology company developing next-generation precision medicines for cancer and immune-inflammatory diseases, reported the upcoming presentation of preclinical data for its first-in-class, wild-type–sparing JAK2-JH2/V617F inhibitor ZE74-0282 at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The company also confirmed plans to initiate first-in-human clinical studies in December 2025.

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Background

The JAK2 V617F mutation is the most common recurring driver mutation in classical myeloproliferative neoplasms (MPNs)—including polycythemia vera, essential thrombocytosis, and myelofibrosis—and is also present in subsets of other myeloid malignancies. The mutation, located in the JH2 pseudokinase domain, causes constitutive hyperactivation of JAK2 signaling.

Approved JAK inhibitors such as ruxolitinib and fedratinib target the JH1 kinase domain, offering symptomatic relief but lacking selectivity for the mutant form. This non-selective inhibition disrupts wild-type (WT) JAK2 signaling essential for normal hematopoiesis, limiting both long-term efficacy and tolerability.

About ZE74-0282

ZE74-0282 is a novel, small-molecule inhibitor rationally designed through in-silico and AI-driven molecular pharmacology to selectively target the JH2 domain of mutant JAK2 V617F while sparing WT JAK2 and other JAK family kinases.

Key non-clinical findings include:

Picomolar potency and > 500-fold selectivity for JAK2 V617F JH2 versus WT JAK2 JH2 in cellular assays.
100× selective inhibition of pSTAT5 phosphorylation and proliferation in BaF3 JAK2 V617F and SET-2 JAK2 V617F cells, with minimal effect on WT cells.
Nanomolar potency in selectively reducing pSTAT5 in myeloid cells from human JAK2 V617F⁺ MPN whole-blood assays, with no effect on lymphoid cells—confirming wild-type sparing. In contrast, ruxolitinib suppressed signaling across both lineages.
Selective inhibition of colony formation from JAK2 V617F/ASXL1-mutant progenitors, without affecting WT JAK2 progenitors, in murine colony-forming assays.
Superior tumor growth inhibition and stronger in-vivo pSTAT5 suppression compared with fedratinib in xenograft models.
Linear pharmacokinetics and toxicokinetics in DRF and GLP toxicology studies, demonstrating safety, tolerability, and a broad therapeutic window supporting optimal clinical dose selection.
Conclusion

ZE74-0282 is the first-in-class, JH2-domain–specific JAK2 inhibitor that selectively targets mutant JAK2 V617F while preserving normal JAK2-mediated hematopoietic signaling. Its differentiated selectivity profile and favorable pharmacology indicate a superior therapeutic index compared with JH1-directed inhibitors. These data support ZE74-0282 as a potentially disease-modifying therapy for patients with JAK2 V617F-driven myeloproliferative disorders.

Eilean Therapeutics plans to initiate its first-in-human clinical study of ZE74-0282 in December 2025.

(Press release, Eilean Therapeutics, NOV 6, 2025, View Source [SID1234659616])

On November 6, 2025 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported a business update and announced financial results for the third quarter ended September 30, 2025.

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"Once again, the recent quarter saw the reporting of positive data from a number of clinical studies involving certepetide, including from the ASCEND, iLSTA, and CENDIFOX trials. Importantly, we also announced a strategic alliance with GATC Health to use their Multiomics Advanced Technology artificial intelligence drug discovery platform to identify product candidates for development, as well as a global license agreement in which Catalent gained access to certepetide for use across various Antibody-Drug Conjugates. Overall, it was a productive and positive quarter marked by our continued vigilance in managing expenses. As a result, we now project that our available cash will fund current operations into the first quarter of 2027," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. "We anticipate a steady flow of additional data through the remainder of 2025 and into 2026."
Development Portfolio Highlights

Certepetide as a treatment for solid tumors in combination with other anti-cancer agents

Certepetide (formerly LSTA1), a proprietary, internalizing RGD (arginyl-glycyl-aspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate the C-end rule active transport mechanism in a tumor specific manner, resulting in systemically co-administered anti-cancer agents more efficiently penetrating and accumulating in the tumor. Additionally, certepetide has been shown to modify the tumor microenvironment ("TME"), diminishing its immunosuppressive nature, enhancing cytotoxic T cell concentration in the TME and inhibiting the metastatic cascade. Lisata and its collaborators have amassed significant clinical and non-clinical data demonstrating enhanced efficacy and acceptable safety of various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies, RNA-based therapeutics, and Antibody-Drug Conjugates ("ADCs") in solid tumor models.

Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma, osteosarcoma, and cholangiocarcinoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.). Currently, certepetide is the subject of multiple ongoing and proposed (subject to sufficient funding) global clinical studies across several solid tumor types in combination with a variety of anti-cancer regimens, including:

•ASCEND: Phase 2b double-blind, randomized (2:1 ratio), placebo-controlled trial evaluating two dosing regimens of certepetide in combination with standard-of-care ("SoC") chemotherapy (gemcitabine/nab-paclitaxel) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma ("mPDAC"). The trial was conducted across 25 sites in Australia and New Zealand led by the Australasian Gastro-Intestinal Trials Group ("AGITG") and coordinated by the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney. Cohort A, with 95 patients receiving a single intravenous ("IV") dose of certepetide 3.2 mg/kg or placebo in combination with SoC, completed enrollment in the third quarter of 2023. Preliminary Cohort A data presented at the 2025 ASCO (Free ASCO Whitepaper)-GI Symposium showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo treated group. Preliminary data from Cohort B, with 63 patients receiving two IV doses of certepetide 3.2 mg/kg or placebo administered 4 hours apart in combination with SoC, was presented at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers ("ESMO-GI") Congress on July 2, 2025. The preliminary Cohort B data demonstrate a positive signal in progression-free survival and objective response rate observed in the certepetide-treated group compared to the placebo-treated group, indicating that the addition of two doses of certepetide (Cohort B regimen) to SoC resulted in a clinically meaningful treatment effect and an attractive safety profile. Additionally, pooled data from both Cohorts A and B, which was presented at the ESMO (Free ESMO Whitepaper) Congress in October 2025, further corroborated previous findings and indicated no increase in adverse events in the certepetide-treated groups beyond those experienced in the SoC alone groups. Final data and key findings from both cohorts of the ASCEND study are anticipated for the first quarter of next year.
•BOLSTER: Phase 2a double-blind, placebo-controlled, multi-center, randomized trial in the U.S. evaluating certepetide in combination with SoC chemotherapy in first- and second-line cholangiocarcinoma ("CCA"). The Company achieved complete enrollment in first-line CCA nearly six months ahead of plan, accelerating anticipated topline data readout to fourth quarter of 2025. Based on investigator enthusiasm, a second cohort was added, evaluating certepetide in combination with SoC in subjects with second-line CCA. In September 2024, Lisata announced the first patient treated in the second-line CCA cohort and more recently, completed enrollment at approximately 20 patients to accelerate data read out and optimize capital allocation.

•CENDIFOX: Investigator-initiated Phase 1b/2a open-label trial in the U.S. evaluating certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon, and appendiceal cancers. In December 2024, the Company announced enrollment completion in all three cohorts. The single-center study, conducted solely at the University of Kansas Cancer Center, was designed with a 3-cycle run-in period to ensure patients met specific criteria before receiving treatment. Of the 66 patients enrolled, 50 patients met the criteria and were treated with certepetide across three cohorts, including 24 with resectable or borderline resectable pancreatic ductal adenocarcinoma ("PDAC"), 15 with high-grade colon or appendiceal cancer and peritoneal metastasis, and 11 with oligometastatic colon cancer. The trial is expected to provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcome information. Preliminary data from the PDAC cohort, presented at the AACR (Free AACR Whitepaper) Special Conference in September 2025, showed that the combination of certepetide with FOLFIRINOX was safe and feasible. In the 10 patients who completed the therapy and underwent surgery, treatment resulted in a 50% R0 resection rate and a 70% pathologic partial response, alongside promising early survival data, including a 60% two-year overall survival rate. Importantly, the combination therapy appears to transform tumors from "immune-cold" to "immune-hot" by enhancing immune cell infiltration and increasing markers like PD-1 and PD-L1, which could significantly improve the efficacy of subsequent immunotherapies. Additional CENDIFOX data are expected in the coming months under the auspices of the investigator. The trial is funded by the University of Kansas Cancer Center and Lisata is supplying certepetide.

•Qilu Pharmaceutical, the licensee of certepetide in the Greater China territory, is developing certepetide in combination with gemcitabine and nab-paclitaxel as a treatment for first-line mPDAC. During the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the study which corroborated previously reported findings from the Phase 1b/2a trial of certepetide plus gemcitabine and nab-paclitaxel conducted in Australia in patients with first-line mPDAC. Qilu has completed enrollment in its Phase 2 trial and data are expected in 2026.

•iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia, funded by WARPNINE Inc., a non-profit foundation, evaluating certepetide in combination with SoC chemotherapy (nab-paclitaxel and gemcitabine) plus SoC immunotherapy (durvalumab) versus SoC alone in patients with locally advanced non-resectable PDAC. Study enrollment is complete and results from an interim analysis were presented at the ESMO (Free ESMO Whitepaper)-GI Congress on July 3, 2025, showing compelling new corroborative data for certepetide. Consistent with the earlier findings presented at the 2025 ASCO (Free ASCO Whitepaper)-GI meeting, the data demonstrate certepetide’s potential to enhance immunotherapy effectiveness by provoking significant RECIST responses and improving overall response and disease control rates. Final data from this study are anticipated in the first quarter of 2026.
•GBM: A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with SoC temozolomide versus SOC alone in patients with newly diagnosed glioblastoma multiforme ("GBM") is being conducted across multiple sites in Estonia and Latvia and is planned to also include a site in Lithuania. The study is targeted to enroll 30 patients with a randomization of 2:1 in favor of the certepetide treatment group. Enrollment is progressing according to plan and completion is expected in 2026.
Notable business development achievements in the third quarter:
•Lisata and Catalent entered into a nonexclusive license agreement that grants Catalent global rights to evaluate certepetide and its analogs for use as SMARTag payloads across multiple ADCs designed to address difficult-to-treat diseases. As presented at the World ADC conference earlier this week, compelling positive data from Catalent’s preclinical study evaluating certepetide and its analogs as non-cytotoxic SMARTag ADC payloads showed not only improved ADC efficacy but broadened distribution of the cytotoxic payload within the tumor, supporting certepetide’s potential to enhance the targeting, penetration, and effectiveness of ADCs in advanced solid tumors.
•Lisata entered into a strategic alliance with GATC Health to exploit GATC’s AI-powered Multiomics Advanced Technology artificial intelligence drug discovery platform to optimize and accelerate drug discovery and development, including analyzing certepetide for new indications and identifying combination therapies.
Third Quarter 2025 Financial Highlights
Operating Expenses
For the three months ended September 30, 2025, operating expenses totaled $4.4 million, compared to $5.3 million for the three months ended September 30, 2024, representing a decrease of $0.9 million or 17.3%.
Research and development expenses were approximately $2.0 million for the three months ended September 30, 2025, compared to $2.5 million for the three months ended September 30, 2024, representing a decrease of $0.6 million or 22.9%. This was primarily due to lower spend on chemistry, manufacturing and controls and a reduction in Clinical department expenses partially offset by an increase in the BOLSTER trial costs.
General and administrative expenses were approximately $2.5 million for the three months ended September 30, 2025, compared to $2.8 million for the three months ended September 30, 2024, representing a decrease of $0.3 million or 12.1%. This was primarily due to lower spend on consulting and the elimination of an employee position.
Overall, net losses were $4.2 million for the three months ended September 30, 2025, compared to $4.9 million for the three months ended September 30, 2024.
Balance Sheet Highlights
As of September 30, 2025, we had cash and cash equivalents of approximately $19.0 million. Based on its existing and planned activities, the Company believes available funds will support current operations into the first quarter of 2027.

Conference Call Information
Lisata will hold a live conference call today, November 6, 2025, at 4:30 p.m. Eastern Time to discuss financial results, provide a business update and answer questions. To join the conference call, please refer to the dial-in information provided below:
Dial-in information:
Participant Toll-Free dial: (800) 715-9871
Participant Toll/Int’l dial: (646) 307-1963
Conference ID: 6375221

To avoid delays, we encourage participants to dial into the conference call 10 minutes ahead of the scheduled start time.
A live webcast of the call will also be accessible under the Investors & News section of Lisata’s website and will be available for replay beginning two hours after the conclusion of the call for 12 months.

(Press release, Lisata Therapeutics, NOV 6, 2025, View Source [SID1234659557])

On November 6, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, reported financial results and business highlights for the third quarter ended September 30, 2025.

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Key Highlights:

Presented New Preclinical Data on INB-619 at ACR Convergence 2025

IN8bio presented compelling new preclinical data on INB-619, its CD19 targeting γδ TCE, at the 2025 American College of Rheumatology (ACR) Convergence Meeting. In preclinical systemic lupus erythematosus (SLE) donor models, INB-619 achieved complete elimination of B cells with efficacy equivalent to commercial CD19 and CD20 engagers, including the FDA-approved compounds blinatumomab and mosunetuzumab.
The data showed that INB-619’s selective γδ T cell activation drives deep B cell depletion with minimal cytokine release, confirming the potential for improved safety over conventional CD3-directed engagers in development.
INB-619’s targeted immune activation and cytokine-sparing design could allow for higher doses, deeper B cell depletion and immune reset that has not been observed with other protein engagers to date.
Expanded INB-100 Clinical Trial to Multiple Sites

IN8bio expanded the Phase 1 trial of INB-100 to include The Ohio State University (OSU), diversifying centers and accelerating patient enrollment.
The addition of Sarah A. Wall, M.D., the Director of Clinical Operations for the Transplant and Cell Therapy Program and an expert in elderly patients with leukemias from this leading academic institution, underscores the strong clinical interest in advancing INB-100, a donor-derived, allogeneic γδ T cell therapy in patients with leukemias undergoing haploidentical stem cell transplantation.
William Ho, CEO and co-founder of IN8bio, commented, "During the quarter, we continued to execute on our goal of developing next-generation γδ T cell therapies. Our focus on the novel biology of γδ T cells underscores our advancements along with the strength and versatility of our DeltEx platform. This quarter, we expanded our INB-100 clinical operations to additional sites to accelerate enrollment, and we reported compelling preclinical data at the 2025 ACR Convergence Meeting. Our INB-619 program is a novel and differentiated program in a sea of CD3-based TCE’s that have yet to achieve immune reset in the autoimmune disease setting. We remain focused on delivering the next generation of γδ T cell therapies designed to redefine immune modulation and improve patient outcomes."

Upcoming Anticipated Pipeline Milestones and Events

Updated Phase 1 and 2 data from the INB-200/400 program in newly diagnosed GBM to be presented at the SNO Annual Meeting, November 19-23, 2025
Additional preclinical data from INB-619 γδ T cell engager program in oncology will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 6-9, 2025
Third Quarter 2025 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $2.1 million for the three months ended September 30, 2025, compared with $3.3 million for the comparable prior year period. This amount includes non-cash items such as stock-based compensation (SBC) and depreciation of $0.5 million for the three months ended September 30, 2025. The change was primarily due to a strategic pause on clinical trial-related activities for the INB-400 program last year and personnel-related costs, which followed the Company’s pipeline prioritization announcement in September 2024. The Company continues to prioritize programs demonstrating the strongest clinical signal and commercial opportunity.
General and administrative (G&A) expenses: G&A expenses were $1.9 million for the three months ended September 30, 2025, compared with $2.7 million for the comparable prior year period. This amount includes non-cash items such as SBC and depreciation of $0.4 million for the three months ended September 30, 2025. The change was primarily due to cost savings related to personnel-related costs, director and officer insurance premiums and professional services.
Net loss: The Company reported a net loss of $3.9 million, or $0.85 per basic and diluted common share, for the three months ended September 30, 2025, compared with a net loss of $7.1 million, or $4.49 per basic and diluted common share, for the comparable prior year period.
Cash position: As of September 30, 2025, the Company had cash of $10.7 million, compared with $4.0 million as of September 30, 2024.

(Press release, In8bio, NOV 6, 2025, View Source [SID1234659573])

On November 6, 2025 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported financial results for the fiscal second quarter ended September 30, 2025 and provided a business update.

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The Company announced on October 20, 2025, that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) resubmission of RP1 for the treatment of advanced melanoma with a Prescription Drug User Fee Act (PDUFA) target action date set for April 10, 2026. The resubmission is considered by the FDA to be a complete response to the complete response letter received on July 21, 2025. In the Type A meeting minutes, the FDA indicated that the IGNYTE-3 trial could potentially support approval.

"After a collaborative dialogue and productive engagement with the FDA we are encouraged by the acceptance of our BLA resubmission for RP1 in combination with nivolumab," said Sushil Patel, Ph.D., CEO of Replimune. "We are currently partnering with the agency on the ongoing review to bring this important therapy to patients."

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

The global Phase 3 trial, IGNYTE-3 assessing RP1 in combination with nivolumab is ongoing. The trial is expected to enroll approximately 400 patients globally and is evaluating RP1 in combination with nivolumab versus a control arm of physician’s choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The primary endpoint of this trial is overall survival, and key secondary endpoints are progression free survival and overall response rate.
Acral melanoma data for RP1 plus nivolumab was recently presented at the ESMO (Free ESMO Whitepaper) Congress 2025. The analysis of acral melanoma data from the IGNYTE anti-PD-1 failed melanoma cohort showed treatment with RP1 combined with nivolumab resulted in an objective response rate (ORR) of 44% (8/18) with a median duration of response of 11.9 months. The safety profile was favorable with generally transient grade 1 and 2 treatment related adverse events.
Additionally, a poster from ESMO (Free ESMO Whitepaper) featuring data from the IGNYTE clinical trial showed that RP1 plus nivolumab provided responses across multiple advanced non-melanoma skin cancer (NMSC) tumor types, including anti–PD-1 naïve and failed disease, as well as both in locally advanced and metastatic disease. The ORR was 100.0%, 33.3%, 66.7%, and 56.3% in patients with anti–PD-1 naïve MCC, BCC, angiosarcoma, and CSCC, respectively. The ORR was 26.3%, 30.0%, 37.5%, and 15.2% in patients with anti–PD-1 failed MCC, BCC, angiosarcoma, and CSCC, respectively. The IGNYTE clinical trial cohort in NMSC is ongoing.
Data from the ongoing ARTACUS Phase 2 trial evaluating the potential of RP1 as monotherapy in cutaneous squamous cell carcinoma patients following organ transplant were recently presented during an oral session at the Society for Melanoma Research 22nd International Congress. A publication for ARTACUS is planned for 2026.

RP2

The registration-directed Phase 2/3 REVEAL trial of RP2 in metastatic uveal melanoma is currently enrolling. The clinical trial is expected to enroll approximately 280 patients with metastatic uveal melanoma who are immune checkpoint inhibitor-naïve and evaluate RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate.
The Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in anti-PD-1/PD-L1 progressed hepatocellular carcinoma is currently enrolling. The protocol is being amended to include RP2 as monotherapy with data planned by the end of 2026. The trial is being conducted under a collaboration and supply agreement with Roche. The Company also expects to enroll its first patient in the fourth quarter of 2025 in a cohort evaluating RP2 in patients with biliary tract cancer. This cohort will evaluate RP2 combined with durvalumab.

Upcoming Events

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 40th Annual Meeting being held November 5th to 9th, 2025:
Late-Breaking Oral Presentation: Biomarker and updated clinical data for RP1 plus nivolumab in anti-PD-1 failed melanoma from the IGNYTE trial demonstrate reversal of mechanisms of resistance to immune checkpoint blockade (Abstract 1327, November 7th, 4:45 pm ET)
Poster: RP1 plus nivolumab in patients with and without prior BRAF-directed therapy: A subgroup analysis of patients with anti–PD-1 failed BRAF-mutant melanoma from the IGNYTE clinical trial (Poster 611, November 7, 5:35-7:00 pm ET)
Poster: Retreatment with RP1 in combination with nivolumab in patients with advanced anti–PD-1 failed melanoma (Poster 600, November 8, 5:10-6:35 pm ET)

Financial Highlights

Cash Position: As of September 30, 2025, cash, cash equivalents and short-term investments were $323.6 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans.

Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of September 30, 2025 will enable the Company to fund operations late into the fourth quarter of 2026 which includes the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.
R&D Expenses: Research and development expenses were $57.9 million for the fiscal second quarter and $43.4 million for the fiscal second quarter ended September 30, 2024. This increase was primarily due to an increase in RP1 direct research costs related to the IGNYTE-3 confirmatory study and other study costs including lab and operating supplies, as well as increased RP2 study costs. In addition, personnel-related costs increased as we continued to prepare for a potential commercial launch of RP1. Research and development expenses included $4.4 million in stock-based compensation expenses for the fiscal second quarter ended September 30, 2025.

S,G&A Expenses: Selling, general and administrative expenses were $26.4 million for the fiscal second quarter ended September 30, 2025, as compared to $15.5 million for the fiscal second quarter ended September 30, 2024. Selling, general and administrative expenses included $4.0 million in stock-based compensation expenses for the fiscal second quarter ended September 30, 2025.
Net Loss: Net loss was $83.1 million for the fiscal second quarter ended September 30, 2025 and $53.1 million for the fiscal second quarter ended September 30, 2024.

About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2

RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

(Press release, Replimune, NOV 6, 2025, View Source [SID1234659589])