Celcuity Inc. (CELC) Presents at Guggenheim Securities Emerging Outlook: Biotech Summit 2026 Transcript

SA Transcripts158.38K FollowersFollow5ShareSaveCommentsPlay Earnings CallPlay Earnings Call Celcuity Inc. (CELC) Guggenheim Securities Emerging Outlook: Biotech Summit 2026 February 11, 2026 9:30 AM EST Company Participants Brian Sullivan - Co-Founder, Chairman & CEO Conference Call Participants Bradley Canino - Guggenheim Securities, LLC, Research Division Presentation Bradley CaninoGuggenheim Securities, LLC, Research Division Thanks, everyone, for continuing to join us here at the Guggenheim Healthcare Conference. My name is Brad Canino. Very happy to be sharing the stage with Brian Sullivan, CEO of Celcuity. Brian, thank you so much for joining us. Brian SullivanCo-Founder, Chairman & CEO Good to see you. Thank you. Question-and-Answer Session Bradley CaninoGuggenheim Securities, LLC, Research Division Transformational last couple of quarters for Celcuity with positive Phase III data in breast cancer. You just announced that you had the NDA accepted with a PDUFA date. So I guess just overview for people in the audience and listening in the time lines for bringing GEDA to market in the PIK3CA wild-type population in breast cancer and then expanding its opportunities beyond that. Brian SullivanCo-Founder, Chairman & CEO Sure. So with the PDUFA date set for July 17, later this year, we would expect to -- the decision is positive to launch the drug soon after that approval is received. And in the meantime, we expect to receive data for the mutant cohort of our VIKTORIA-1 study sometime either later this quarter or sometime in Q2. And so going into the launch, we'll have a full data set for all the patients, PIK3CA wild-type and PIK3CA mutant available to physicians as they evaluate GEDA for the first time. Bradley CaninoGuggenheim Securities, LLC, Research Division Okay. What is your expectation for review time lines with the RTOR program and the potential for that to come in a bit earlier than the July date?