RP2

Replimune Reports Fiscal Third Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, February 8, 2024
Carcinoma, Neoplasm, Melanoma, NMSC, Merkel-cell carcinoma, REPL, Angiosarcoma, SITC, PFS, Clinical trial, Research, RECIST, Society, Hercules, Patient, CSCC, Type, FDA, Marketing, Investment, RP1, Food, MCC, Immunotherapy, Skin, Nivolumab, Uveal melanoma, Annual general meeting, BLA, RP2, Pharmaceutical industry

WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update.

Key Points: 
  • WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update.
  • We plan to submit a BLA for the treatment of patients with anti-PD1 failed melanoma in 2H 2024.
  • Selling, general and administrative expenses included $4.5 million in stock-based compensation expenses for the third quarter ended December 31, 2023.
  • Net Loss: Net loss was $51.1 million for the third quarter ended December 31, 2023, as compared to a net loss of $39.7 million for the third quarter ended December 31, 2022.

Replimune Shares Initial Primary Analysis Results from CERPASS Clinical Trial in Advanced Cutaneous Squamous Cell Carcinoma and Presents New Data from IGNYTE Clinical Trial of RP1 in Anti-PD1 Failed Melanoma and Non-Melanoma Skin Cancers

Retrieved on: 
Tuesday, December 5, 2023
Chills, CRS, Melanoma, RP1, CRC, Food, Melanoma Research, RECIST, NMSC, Transplant, Diarrhea, FDA, Cytokine release syndrome, Colorectal cancer, SCCHN, Type, RP3, CRR, Fatigue, Headache, Nausea, Itch, Myocarditis, Incidence, Nivolumab, Influenza-like illness, Research, Clinical trial, Injection site reaction, Myalgia, CSCC, Skin cancer, HCC, Weakness, Society, Head, Appetite, RP2, Regeneron Pharmaceuticals, Carcinoma, Investment, Webcast, Patient, Lipase, Angiosarcoma, MCC, Vomiting, Neck, Uveal melanoma, Rash, BLA, Pharmaceutical industry

The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.

Key Points: 
  • The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.
  • The ORR was comparable between the two study groups (52.5% for RP1 plus cemiplimab vs. 51.4% for cemiplimab alone, p=0.692).
  • The registration directed anti-PD1 failed melanoma cohort from the IGNYTE clinical trial includes 140 patients and completed enrollment earlier this year.
  • RP1 monotherapy was well tolerated, and the safety profile was similar to that observed in non-immunocompromised patients with advanced skin cancers.

Replimune Presents Updated Data on RP2 in Uveal Melanoma during Plenary Session at the 20th International Congress of the Society for Melanoma Research

Retrieved on: 
Wednesday, November 8, 2023
Survival, FRCP, Research, Uveal melanoma, International Congress on Tuberculosis, Trae tha Truth, Nivolumab, University of Liverpool, Bachelor of Medicine, Bachelor of Surgery, DOR, Melanoma, Liver, Clatterbridge Cancer Centre NHS Foundation Trust, Doctor of Philosophy, Ipilimumab, Development, Lung, 8th Plenary Session of the Central Committee of the League of Communists of Serbia, Disease, Hypotension, Liver disease, Metastasis, RP2, Itch, Uvea, Immunotherapy, ORR, Chills, University, Society, Melanoma Research, Patient, Toxicity, Fatigue, Pharmaceutical industry, Fever

The data were presented by Dr. Joseph Sacco during a Plenary Session at the 20th International Congress of the Society for Melanoma Research in Philadelphia.

Key Points: 
  • The data were presented by Dr. Joseph Sacco during a Plenary Session at the 20th International Congress of the Society for Melanoma Research in Philadelphia.
  • The median duration of response (DOR) at the data cutoff was 11.47 months (range of 2.78 to 21.22 with responses ongoing).
  • RP2 was generally well tolerated both as monotherapy and in combination with nivolumab with no additive adverse events observed.
  • “These data from the trial cohort evaluating RP2 as monotherapy and in combination with nivolumab in metastatic uveal melanoma are highly promising,” said Robert Coffin, President and Chief Research & Development Officer at Replimune.

Replimune Reports Fiscal Second Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 7, 2023
Bevacizumab, Patient, FDA, Research, Carboplatin, RP1, NMSC, Biologics license application, Nivolumab, Biotechnology, Financial management, Carcinoma, Cisplatin, Data collection, Disclosure, SITC, Immunotherapy, 8th Plenary Session of the Central Committee of the League of Communists of Serbia, Initiation, RP3, Clinical trial, Marketing, Melanoma, Skin, Annual general meeting, RP2, PTC, CFO, Roche, Society, CSCC, PTC Therapeutics, Therapy, Investment, Calendar, BLA, D, Merkel-cell carcinoma, Pharmaceutical industry, Nursing, Cryptocurrency

WOBURN, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, today announced financial results for the fiscal second quarter ended September 30, 2023 and provided a business update.

Key Points: 
  • R&D Expenses: Research and development expenses were $49.1 million for the second quarter ended September 30, 2023, as compared to $28.8 million for the second quarter ended September 30, 2022.
  • S,G&A Expenses: Selling, general and administrative expenses were $14.7 million for the second quarter ended September 30, 2023, as compared to $12.7 million for the second quarter ended September 30, 2022.
  • Selling, general and administrative expenses included $4.7 million in stock-based compensation expenses for the second quarter ended September 30, 2023.
  • Net Loss: Net loss was $60.0 million for the second quarter ended September 30, 2023, as compared to a net loss of $43.1 million for the second quarter ended September 30, 2022.

Replimune Reports Fiscal First Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 3, 2023
Bevacizumab, Radiation, CRC, Skin, Roche, Clinical trial, Merkel-cell carcinoma, SCCHN, Data collection, Uveal melanoma, RP3, Incyte, SOC, Cisplatin, RP1, ASCO, ORR, CSCC, American Society of Clinical Oncology, Cytokine release syndrome, Patient, Standard of care, Melanoma, Carcinoma, CPS, Annual general meeting, Liver, Nivolumab, ATC, RP2, Kinetics, BLA, PD-L1, Society, Safety, Fatigue, Pharmaceutical industry, Vaccine, Medical imaging, Nursing

“It was a productive quarter with positive updates for RP1 in anti-PD1 failed melanoma and RP2 in uveal melanoma presented at ASCO.

Key Points: 
  • “It was a productive quarter with positive updates for RP1 in anti-PD1 failed melanoma and RP2 in uveal melanoma presented at ASCO.
  • S,G&A Expenses: Selling, general and administrative expenses were $15.2 million for the first quarter ended June 30, 2023, as compared to $11.4 million for the first quarter ended June 30, 2022.
  • Selling, general and administrative expenses included $5.5 million in stock-based compensation expenses for the first quarter ended June 30, 2023.
  • Net Loss: Net loss was $49.6 million for the first quarter ended June 30, 2023, as compared to a net loss of $42.3 million for the first quarter ended June 30, 2022.

Replimune Presents RP1 Data from the IGNYTE anti-PD1 Failed Melanoma Cohort and RP2 Data in Uveal Melanoma at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Saturday, June 3, 2023
Abstract, Radiation, Progression-free survival, Neoplasm, Clinical trial, OS, SCCHN, BRAF, Uveal melanoma, RP3, Bristol Myers Squibb, SOC, RP1, PFS, ASCO, Development, Patient, Cytokine release syndrome, Standard of care, Melanoma, CPS, GM-CSF, Liver, RP2, Kinetics, ORR, Safety, Fatigue, Nivolumab, Medical imaging, Pharmaceutical industry, Nursing, Vaccine

WOBURN, Mass., June 03, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced updated data from the first 75 patients in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial along with data from the ongoing Phase 1 trial of RP2 combined with nivolumab in patients with uveal melanoma are being presented at the ASCO annual meeting. The anti-PD1 failed melanoma cohort of the IGNYTE clinical trial evaluating RP1 (vusolimogene oderparepvec) in combination with nivolumab is registration-directed.

Key Points: 
  • The anti-PD1 failed melanoma cohort of the IGNYTE clinical trial evaluating RP1 (vusolimogene oderparepvec) in combination with nivolumab is registration-directed.
  • The anti-PD1 failed melanoma cohort is registration-directed and completed enrollment earlier in the year with 141 patients enrolled.
  • These updated data include the first 75 patients from the anti-PD1 failed melanoma cohort combined with the 16 anti-PD1 failed melanoma patients from the prior all comers 30 patient melanoma cohort (n=91 in total).
  • Data in uveal melanoma patients from the Phase 1 clinical trial evaluating RP2 in combination with nivolumab was presented.

Replimune to Present at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Thursday, May 25, 2023
McCormick Place, REPL, Uveal melanoma, RP1, ASCO, American Society of Clinical Oncology, Patient, Melanoma, RP2, Society, Nivolumab, Pharmaceutical industry

WOBURN, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced multiple presentations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, IL from June 2-6, 2023.

Key Points: 
  • WOBURN, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced multiple presentations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, IL from June 2-6, 2023.
  • Replimune has one abstract selected for a poster discussion session that will include updated results from the first 75 patients treated with RP1 combined with nivolumab from the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial.
  • In addition, the Company will also present data from the Phase 1 trial of RP2 combined with nivolumab in uveal melanoma, and trial-in-progress posters from the RP2/3 programs.
  • Abstract Title: Preliminary safety and efficacy results from an open-label, multicenter, phase 1 study of RP2 as a single agent and in combination with nivolumab in a cohort of patients with uveal melanoma

Replimune Reports Fiscal Fourth Quarter and Year Ended 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, May 18, 2023
Bevacizumab, Radiation, CRC, Skin, Roche, Clinical trial, SCCHN, RP3, SOC, RP1, ASCO, CSCC, Patient, Standard of care, Melanoma, CPS, RP2, BLA, HCC, Nivolumab, Pharmaceutical industry

WOBURN, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, today announced financial results for the fiscal fourth quarter and year ended March 31, 2023 and provided a business update.

Key Points: 
  • R&D Expenses: Research and development expenses were $37.9 million for the fourth quarter and $126.5 million for the fiscal year ended March 31, 2023, as compared to $21.7 million for the fourth quarter and $79.5 million for the fiscal year ended March 31, 2022.
  • Research and development expenses included $2.3 million in stock-based compensation expenses for the fourth quarter and $10.1 million in stock-based compensation expenses for the fiscal year ended March 31, 2023.
  • Selling, general and administrative expenses included $4.6 million in stock-based compensation expenses for the fourth quarter and $18.1 million in stock-based compensation expenses for the fiscal year ended March 31, 2023.
  • Net Loss: Net loss was $49.2 million for the fourth quarter and $174.3 million for the fiscal year ended March 31, 2023, as compared to a net loss of $31.7 million for the fourth quarter and $118.0 million for the fiscal year ended March 31, 2022.

Replimune Reports Fiscal Third Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, February 9, 2023
Osteosarcoma, Sarcoma, Liver, Standard of care, Breast cancer, Skin cancer, Melanoma, GI, RP2, SCCHN, Bevacizumab, HCC, Skin, Roche, Patient, Uveal melanoma, CPS, RP1, Colorectal cancer, ORR, CSCC, Clinical trial, Epithelioid, Lung cancer, Nivolumab, RP3, SOC, Investment, CRC, Head, Radiation, Chondrosarcoma, Exercise, Hepatocellular carcinoma, Pharmaceutical industry, Medical imaging, Leiomyosarcoma

WOBURN, Mass., Feb. 09, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2022 and provided a business update.

Key Points: 
  • Research and development expenses included $2.6 million in stock-based compensation expenses for the third quarter ended December 31, 2022.
  • S,G&A Expenses: Selling, general and administrative expenses were $11.4 million for the third quarter ended December 31, 2022, as compared to $10.3 million for the third quarter ended December 31, 2021.
  • Selling, general and administrative expenses included $4.4 million in stock-based compensation expenses for the third quarter ended December 31, 2022.
  • Net Loss: Net loss was $39.7 million for the third quarter ended December 31, 2022, as compared to a net loss of $29.7 million for the third quarter ended December 31, 2021.

Replimune Appoints Former Sanofi U.S. Commercial Oncology Head, Chris Sarchi, as Chief Commercial Officer and Sushil Patel as Chief Strategy Officer

Retrieved on: 
Wednesday, January 4, 2023
Hoffmann-La Roche, IMS Health, Boehringer Ingelheim, Head, Genentech, University of London, Squamous cell carcinoma, RP1, RP2, Health, GSK, Skin, CSCC, RP3, University, Imperial College London, Center for Study of Science, Technology and Policy (CSTEP), Nursing, BCC, Marketing, Molecular biology, Management, Fine chemical, Sanofi, Biotechnology, Science, Medicine, Vismodegib, Biosimilar

“These leadership appointments provide broad strategic and operational commercial acumen as we ramp up our commercial planning ahead of the potential 2024 commercial launch of RP1,” said Philip Astley-Sparke, Chief Executive Officer of Replimune.

Key Points: 
  • “These leadership appointments provide broad strategic and operational commercial acumen as we ramp up our commercial planning ahead of the potential 2024 commercial launch of RP1,” said Philip Astley-Sparke, Chief Executive Officer of Replimune.
  • “Chris led the launch of Libtayo in cutaneous squamous cell carcinoma (CSCC) at Sanofi, and was also involved with the launch of Erivedge in basal cell carcinoma (BCC) when at Genentech.
  • Sush will partner with Chris on our go-to-market strategy in the U.S. with RP1 and also in defining our commercialization strategy for the rest of the world.
  • Chris began his career with GSK where he held several sales and marketing leadership roles of increasing responsibility.