Pharma Co. Enrolls First Patient in Trial
Research Report

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Disclosures for H.C. Wainwright & Co., Rigel Pharmaceuticals Inc., September 5, 2024

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H.C. Wainwright & Co. analyst Dr. Joseph Pantginis, in a research report published on September 5, 2024, provided an update on Rigel Pharmaceuticals (RIGL:NASDAQ) following the company's announcement of enrolling the first patient in its Phase 1b/2 triplet therapy trial for Rezlidhia (olutasidenib). The analyst maintained a Buy rating and a price target of US$57.00 on the stock.

Rigel announced the enrollment of the first patient in a Phase 1b/2 trial assessing decitabine and venetoclax in combination with Rezlidhia in mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML).

Pantginis noted, "The trial, that is sponsored and being conducted by MD Anderson, is designed as a multi-center, open-label, non-randomized clinical study."

The analyst highlighted the trial's structure, stating, "The Phase 1b portion intends evaluate the safety and tolerability and determine recommended Phase 2 dose (RP2D) of oral or intravenous (i.v.) decitabine and venetoclax in tandem with olutasidenib in r/r mIDH1 patients. The Phase 2 part plans to include 60 patients, and its primary objective is to determine the complete remission rate in both newly diagnosed (n=30) and r/r mIDH1 AML patients (n=30)."

Pantginis also discussed Rigel's recent expansion of its partnership with Kissei Pharmaceuticals, which includes an exclusive license and supply agreement for Rezlidhia in Japan, South Korea, and Taiwan. "We welcome this news as it strengthens the already strong partnership between Rigel and Kissei," the analyst commented.

Rigel's strategic focus includes developing Rezlidhia for various indications and exploring additional ex-U.S. partnership opportunities. The company's recent milestones include the U.S. approval of Rezlidhia for relapsed or refractory mIDH1 AML and the expanded partnership with Kissei Pharmaceuticals.

H.C. Wainwright's valuation methodology for Rigel Pharmaceuticals is based on a clinical net present value (NPV) model. "Our price target is based on our clinical net present value (NPV) model, which derives its value from: (1) Tavalisse in ITP (62% contribution) and (2) AML contribution from Rezlidhia (27% contribution) and (3) Gavreto contribution for RET NSCLC and thyroid cancer (11% contribution)," Pantginis explained.

With a Buy rating and a price target of US$57.00, representing a potential return of approximately 332% from the price at the time fo the report of US$13.18, H.C. Wainwright sees significant upside potential for Rigel Pharmaceuticals.

Pantginis concluded by noting, "We highlight that we do not include additional indications Rezlidhia or pipeline assets, all representing potential upside potential to our valuation."