H.C. Wainwright Reiterates Buy Rating on Replimune Group (REPL)

H.C. Wainwright analyst Raghuram Selvaraju reiterated a Buy rating and $17.00 price target on Replimune Group (NASDAQ: REPL).

The analyst commented: "Over the weekend at the ESMO conference in Barcelona, Spain, Replimune presented the full results from the primary analysis of the IGNYTE trial, which is evaluating RP1 + Opdivo in anti-PD1 failed melanoma patients. RP1 + Opdivo (n=140; 100% prior anti-PD1; 65.7% had primary resistance to anti-PD1; 43.6% had prior anti-PD1 + anti-CTLA4) achieved an independent, centrally reviewed objective response rate (ORR)—defined by modified RECIST v1.1 criteria—of 33.6% and an ORR—by RECIST v1.1—of 32.9%, with a median duration of response (mDOR) from response initiation of 21.6 months and a mDOR from treatment initiation of 27.6 months. Notably, RP1 + Opdivo's response rate appears consistent across all sub-groups analyzed, with the lowest ORR being 27.7%. We are also seeing RP1 + Opdivo exert an abscopal effect, with numerous patients exhibiting non-injected lesions that responded to the combination. We remind investors that an ORR of 10% or less would be expected with an anti-PD1 agent alone in an anti-PD1-refractory melanoma population, with Opdualag (nivolumab/relatlimab combo) also achieving a 12% ORR in a subgroup of 354 patients who had progressed on at most one line of immunotherapy (including 40% who were also treated in combination with a CTLA-4 therapy) in the RELATIVITY-020 trial. The one-, two-, and three-year survival rates were 75.3%, 63.3%, and 54.8%, respectively. Lastly, RP1 + Opdivo has a relatively benign safety profile (12.8% G3+ TRAEs); for example, the AE with the highest G3+ rate is fatigue, at only 0.7% of patients. We believe this provides differentiation vs. autologous tumor-infiltrating lymphocyte (TIL) therapy Amtagvi (lifileucel), which showed a 31.4% ORR (5.9% CR) in cohorts 2 + 4, a 36.5-month mDOR, and a 13.9-month mOS, with 94.9% of patients experiencing G3+ TEAEs (source: SITC 2022). In our view, these results support potential accelerated approval of RP1 + Opdivo in anti-PD1 failed melanoma patients. We reiterate our Buy rating and 12-month price target of $17."

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Shares of Replimune Group closed at $11.13 yesterday.

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