| Over a week ago | ||||
Revolution Medicines… Revolution Medicines highlights the election of Sushil Patel, Ph.D., to its board of directors at its recent annual meeting of stockholders. Dr. Patel currently serves as chief commercial officer of Replimune Group (REPL), a clinical-stage biotechnology company developing novel tumor-directed oncolytic immunotherapies. | ||||
| Over a month ago | ||||
Replimune Group announced… Replimune Group announced Jason Rhodes, partner at Atlas Venture, has resigned from the company's Board of Directors. Mr. Rhodes joined the Replimune Board in 2015, concurrent with Atlas Venture leading Replimune's Series A financing. Mr. Rhodes has resigned to focus his efforts on his growing commitments at Atlas Venture, including the recent launch of its new fund, announced in March 2022. | ||||
Wedbush analyst Robert… Wedbush analyst Robert Driscoll lowered the firm's price target on Replimune Group to $52 from $59 as he tweaks his model in the current financing environment, but kept an Outperform rating on the shares. The analyst notes the company recently provided clinical updates and an overview for its oncolytic virus programs, including incremental but positive data updates from the IGNYTE study of RP1 including in PD-1 refractory melanoma and 1L CSCC patients that support the ongoing registration directed studies. | ||||
Piper Sandler analyst Do… Piper Sandler analyst Do Kim lowered the firm's price target on Replimune Group to $44 from $52 as he increases his discount rate to 16% from 14% and WACC to 9.6% from 6.7%, due to a higher beta and 10YR Treasury rate, partly offset by his DCF valuation being pushed forward by 6 months. The analyst notes Replimune reported Q4 GAAP EPS in line with his estimate but below Street's. He expects second half of 2022 to be rich with data catalysts, with RP1 Phase 2 data in PD1-failed melanoma, potential first look at RP1 NSCLC data, additional RP2 cohort in specific tumor types and updated RP3 Phase 1 data including in combo with Opdivo. Kim also expects RP2 or RP3 to advance into the broad Phase 2 program before year-end, depending on which drug shows the better profile in the upcoming data. The analyst has an Overweight rating on the shares. | ||||
As of March 31, 2022,… As of March 31, 2022, cash, cash equivalents and short-term investments were $395.7 million, as compared to $476.3 million as of March 31, 2021. The decrease was primarily related to cash utilized in operating activities in advancing the Company's expanded clinical development plan. Based on the current operating plan, Replimune believes that existing cash and cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into the second half of 2024, excluding any confirmatory trial required by the FDA or other regulatory body. | ||||
"We have ended the… "We have ended the fiscal year in a very strong position from which to execute on our vision to establish our products as a cornerstone of immuno-oncology regimens and we look forward with these firm foundations in place to a potentially transformative 12-month period ahead," said Philip Astley-Sparke CEO of Replimune. "Updated data in anti-PD1 naive cutaneous squamous cell carcinoma and anti-PD1 failed melanoma continue to support our two registration-directed clinical trials in these settings. We are maintaining guidance that we expect to complete enrollment into our registration directed CERPASS clinical trial in CSCC mid-year and to release top line data in early 2023. Further, we expect to release initial directional data from our registration directed IGNYTE clinical trial in anti-PD1 failed melanoma in late 2022. Launch scale manufacturing has been established and commercial planning to establish a major skin cancer franchise is advancing. With RP2/3 we have announced an exciting mid stage program in colorectal cancer, hepatocellular carcinoma and head and neck cancer where an expedited path to potential approval in some settings may be feasible. Finally, we have a strong cash position to drive value through multiple major data catalysts." | ||||
| Over a quarter ago | ||||
Virtual Investor Day 2022… Virtual Investor Day 2022 will be held on March 30 at 8 am. Webcast Link | ||||
Replimune provided a… Replimune provided a detailed overview of its RP2/3 Phase 2 development plans. RP2/3 Phase 2 Clinical Development Plan: The Phase 2 development plan for RP2 and RP3 is intended to target tumor types in large underserved markets, including where liver metastases are common, as well as patients with primary liver cancer, and patients with early disease where the objective of treatment would be to achieve cure. This includes the development of RP2/3 in combination with the current standard of care, including immunotherapy, chemotherapy and radiation, and in settings following the current SOC. The following indications for signal finding single arm Phase 2 clinical trials have been identified which meet these criteria: Locally advanced and 1L recurrent SCCHN in combination with chemoradiation followed by anti-PD1 therapy, or SOC chemotherapy and anti-PD1 therapy, respectively. 1L and 2L hepatocellular carcinoma in combination with SOC immunotherapy and anti-PD1 therapy respectively. 3L micro-satellite stable colorectal cancer in combination with anti-PD1 therapy. Additional signal finding work is also intended in other indications. Replimune has a clinical trial collaboration and supply agreement with BMS for the supply of Opdivo in its clinical trial program with RP2/3. The RP2/3 Phase 2 program is expected to initiate around the year end. | ||||
Replimune announced… Replimune announced updated data from completed cohorts of the Phase 2 part of the IGNYTE clinical trial in non-melanoma skin cancer, NMSC, and melanoma. Additionally, the Company announced new data from the ongoing clinical trial in anti-PD1 failed NMSC and from the ARTACUS clinical trial, a Phase 1b/2 trial of RP1 as monotherapy in solid organ transplant recipients with skin cancer. RP2/3 Development Strategy: RP2 leverages the Company's platform to express an anti-CTLA-4 antibody, in addition to the GALV-GP R- and GM-CSF expressed by RP1. The Company will review data from the Phase 1 clinical trial of RP2 alone and in combination with Opdivo and announce its development strategy for the Phase 2 clinical development of RP2/3. After fully enrolling patients in the RP2 monotherapy and combination with Opdivo cohorts in the Phase 1 clinical trial with RP2, a further cohort of Phase 1 patients with tumor types of particular interest was recently opened. RP3 further expresses CD40L and 4-1BBL in addition to anti-CTLA-4 and GALV-GP R-, is intended to induce a broad and potent anti-tumor immune response, and for which a Phase 1 clinical trial is also underway. The higher dose level has been confirmed as the recommended Phase 2 dose. The first six patients enrolled in this Phase 1 clinical trial had heavily pre-treated advanced sarcoma, esophageal cancer, colorectal cancer, head and neck cancer and melanoma. Three of the six patients died due to disease progression approximately two to four months from initiating the study, indicating the advanced nature of disease of the patients enrolled. Two other patients also had rapid progressive disease, and one patient with esophageal cancer had stable disease out to one year. Enrollment into the cohort of patients dosed with RP3 combined with Opdivo has also recently commenced. This cohort will focus on enrolling patients with GI cancers, breast cancer, lung cancer and head and neck cancer. | ||||
