On December 09, 2022 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported it has entered into an exclusive worldwide license agreement with Novartis (NYSE: NVS) for naporafenib, a Phase 2 pivotal-ready pan-RAF inhibitor with a potential first-in-class and best-in-class profile in NRAS mutant (NRASm) melanoma and other RAS/MAPK pathway-driven tumors (Press release, Erasca, DEC 9, 2022, View Source [SID1234634765]). To date, naporafenib has been dosed in over 500 patients across multiple trials and has demonstrated preliminary clinical proof-of-concept as well as favorable safety and tolerability data both as a single agent and in combination with other molecularly targeted and immuno-oncology therapies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As separately announced, Erasca has priced a $100 million equity offering with select healthcare investors.

"Naporafenib aligns with our mission by expanding our addressable patient population and is a perfect strategic fit for Erasca based on its strong synergy with our pipeline," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "This Phase 2 pivotal-ready molecule with favorable clinical safety, tolerability, and proof-of-concept data significantly accelerates our transition into a late-stage development company, bringing us closer to realizing our aspiration of delivering novel cancer therapies to patients in need. This license, coupled with our simultaneous financing from leading healthcare investors, solidifies our leadership in advancing treatments for RAS/MAPK pathway-driven cancers."

Naporafenib (LXH254) is a potent and selective inhibitor of BRAF and CRAF, with a potential first-in-class and best-in-class profile. Safety, tolerability, and preliminary proof of concept of naporafenib alone or in combination have been shown in over 500 patients treated to date in NRASm melanoma and other RAS/MAPK pathway-driven tumors. Erasca plans to initially focus on advancing and securing potential regulatory approval for naporafenib plus trametinib (MEKINIST) in RAS Q61X tissue agnostic solid tumors as part of the planned Phase 2 SEACRAFT-1 trial and NRASm melanoma as part of the planned Phase 3 SEACRAFT-2 trial.

Under the terms of the license agreement, in exchange for an exclusive worldwide license to develop and commercialize naporafenib, Erasca will pay to Novartis a one-time upfront cash payment of $20 million and $80 million of shares in Erasca common stock at a price of $6.50 per share. Novartis is eligible to receive up to $80 million in cash upon the achievement of regulatory milestones covering two indications in the United States, Europe, and Japan, as well as up to $200 million in cash upon the achievement of sales milestones. Novartis is also eligible to receive a low single-digit percentage royalty on net sales of naporafenib.

Conference Call and Webcast Information
Erasca will hold a conference call and webcast today at 8:30 am ET. The webcast link for the conference call is View Source The dial-in number is 1-877-407-0792 (U.S./Canada) or 1-201-689-8263 (international). The conference ID for all callers is 13734524. The live webcast and replay may be accessed by visiting Erasca’s website at Erasca.com/events.