Managing Director and Senior Biotech Analyst at Truist Securities
Robyn Karnauskas is a Managing Director and Senior Biotech Analyst at Truist Securities, specializing in equity research coverage of biotechnology and pharmaceutical companies including Merck, among others. She has delivered more than 180 ratings with an approximate 42% success rate and notable high-return calls, ranking in the top 1,000 analysts on TipRanks. Beginning her career at Bear Stearns in 2004, she later advanced at Citigroup before joining Truist in 2019. Karnauskas holds a B.S. from MIT, a Ph.D. from the University of Chicago, and is registered with FINRA and SIPC, underscoring her professional credentials.
Asked about the choice of the 120mg dose for the at-home setting, clarity from the FDA on this dose, and how to think about the company's funding options for its various programs.
The company has 'crystal clarity' from the FDA on using the 120mg dose for the at-home study, which has established efficacy. For funding, the top priority is the capital-efficient TRANQUILITY trial, followed by SERENITY.
Robyn Karnauskas of Truist asked for an update on the news flow cadence for the pipeline beyond zandelisib, and also sought commentary on the evolving FDA landscape for oncology drugs and the impact of new legislation on small molecule development.
President and CEO Dan Gold outlined upcoming catalysts, noting the voruciclib program in AML is expected to enroll patients shortly and could yield initial data in the coming year, while the ME-344 study in colorectal cancer is set to begin in Q1. Gold also acknowledged the heightened FDA scrutiny and new legislative challenges, stating the company must adapt its clinical strategies but believes zandelisib's unique profile differentiates it.
Robyn Karnauskas of SunTrust Securities asked about the safety bar for the TIDAL study that would be acceptable to the FDA, what new data to expect in the upcoming Phase 1b publication, and the company's development and partnership strategy for its pipeline assets ME-344 and voruciclib.
President and CEO Dan Gold explained that while there is no written FDA regulation on tolerability, the company's primary focus is on ensuring zandelisib's safety profile is differentiated from others in its class. He stated the upcoming publication will feature longer follow-up data from the Phase 1b study. Regarding pipeline strategy, Gold noted that building out commercial capabilities provides flexibility, and while they don't necessarily need large global partnerships, they will follow the data and evaluate all strategic options.