Josh Schimmer

Josh Schimmer asked for more details on the next steps for VIR-5500 before Vir Biotechnology and Astellas move to Phase III, and whether there are plans to explore additional dosing schemes beyond the every three-week regimen.

Answer

Mark Eisner, EVP and Chief Medical Officer, outlined the next steps, including initiating expansion cohorts in Q2 for late-line mCRPC monotherapy, early-line mCRPC in combination with enzalutamide, and metastatic hormone-sensitive prostate cancer in combination. He also mentioned parallel dose optimization for Project Optimus, with Phase III expected in 2027. Marianne De Backer, CEO and Director, emphasized that the partnership accelerates clinical development and broadens the program's potential.

Josh Schimmer asked for more color on the next steps before Vir Biotechnology and Astellas move to Phase 3, specifically inquiring if there are plans to explore additional dosing schemes beyond the Q3W regimen.

Answer

Mark Eisner, EVP and Chief Medical Officer, stated that a go-forward dose has been selected, and expansion cohorts are planned for Q2, including late-line mCRPC monotherapy, combination with enzalutamide in early-line taxane-naive mCRPC, and metastatic hormone-sensitive prostate cancer in combination. He added that dose optimization will occur in parallel to meet Project Optimus goals, with Phase 3 expected in 2027. Marianne De Backer, CEO and Director, emphasized that the partnership accelerates development and broadens potential.

Josh Schimmer asked about the rationale for collaborating with GORTEC for the ILLUMINE phase III study in head and neck cancer and what specific signals would trigger an expansion into the U.S., potentially leveraging it for U.S. approval.

Answer

Dave Gancarz, Chief Business and Strategy Officer, and Allen Yang, Chief R&D Strategy Officer, explained that working with GORTEC expands the phase III program, addresses unmet needs, and leverages the cooperative group's enthusiasm and expertise for multi-regional exploration. They mentioned factors like enrollment enthusiasm, GORTEC feedback, Akeso's phase III data in China, and maturing Phase II data as considerations for U.S. expansion, but did not disclose specific triggers.

Josh Schimmer asked why Summit opted to collaborate with a cooperative group for the Phase III head and neck study (ILLUMINE), what signals would trigger a U.S. expansion, and if the data could support a U.S. approval.

Answer

Dave Gancarz, Chief Business and Strategy Officer, stated that working with cooperative groups like GORTEC expands the number of trials and indications, especially in competitive areas like head and neck cancer. Allen Yang, Chief R&D Strategy Officer, added that GORTEC approached Summit, and while head and neck is an unmet need, Summit focuses resources on the largest unmet needs. Dave Gancarz mentioned that U.S. expansion would depend on enrollment enthusiasm, GORTEC feedback, Akeso's Phase III data in China, and maturing Phase II data, but no specific triggers were disclosed.

Josh Schimmer asked if BridgeBio has discussed with payers what might happen to Attruby's formulary positioning when Tafamidis generics enter, and if they've discussed combination therapy with payers given its cost and lack of data.

Answer

Neil Kumar, CEO and Founder, BridgeBio Pharma, stated that BridgeBio has not had discussions with payers regarding Tafamidis generics or combination therapy. He believes payers will eventually exert more control over the category but not within the next 6 to 12 months. Matt Outten, COO, BridgeBio Pharma, emphasized their focus on ensuring Attruby's availability to patients and competing on data in the doctor's office rather than in the payer space.

Josh Schimmer asked if BridgeBio has had discussions with payers regarding Atrobi's formulary positioning when Tafamidis generics enter the market, and if they've discussed combination therapy with payers given its cost and lack of supporting data.

Answer

Neil Kumar, CEO and Founder, BridgeBio Pharma, stated that BridgeBio has not had discussions with payers regarding Tafamidis generics or combination therapy. He believes payers will eventually exert more control over the category but not within the next 6 to 12 months. Matt Outten, Chief Commercial Officer, BridgeBio Pharma, emphasized focusing on ensuring Atrobi's availability and leveraging its data in discussions with physicians.

Josh Schimmer of Cantor Fitzgerald asked for an update on the experience with LFT elevations seen with adamelin, given prior scrutiny, and inquired about the plan for future updates on the drug's liver safety profile.

Answer

Founder and CEO R. Scott Struthers stated the company is very comfortable with the emerging and growing safety experience with adamelin. He indicated that updates will be provided as the data matures and becomes meaningful, suggesting that as the program expands into Phase III and open-label extensions, the growing experience will provide more comfort and that "no news is good news."

Josh Schimmer of Cantor Fitzgerald asked if any patients eligible for the EXPAND study are already receiving LIVMARLI through compassionate use or other programs.

Answer

Chief Medical Officer Joanne Quan explained that while the EXPAND study was initiated due to numerous compassionate use requests, the trial itself is enrolling treatment-naive patients to properly assess response. This ensures the integrity of the study data.

Josh Schimmer from Cantor Fitzgerald sought to clarify if the guided Q3 revenue decline was U.S.-only and asked about the heavy weighting of R&D expenses towards the oncology program.

Answer

Chairman & CEO Krish Krishnan confirmed the Q3 revenue decline commentary was specific to the U.S. market. President of R&D Suma Krishnan explained the high oncology R&D cost is due to the expensive combination trial with Keytruda and preparations for a potential future controlled study.

Josh Schimmer from Evercore ISI asked what specific data to expect from the DUBLIN-3 trial presentation at ESMO, particularly regarding subset analyses for Western and PD-1/PD-L1 exposed patients. He also questioned if the trial's ex-U.S. patient majority would be sufficient for FDA approval and how that uncertainty impacts potential partnership discussions.

Answer

Co-Founder, Chairman and CEO Lan Huang confirmed that the ESMO presentation would include full ITT population data and the eagerly awaited subset analyses. Dr. Huang addressed the FDA approval concern by noting that 27% of FDA oncology approvals have used less than 10% U.S. data, and the topic would be discussed with the FDA in a planned pre-NDA meeting. She declined to provide details on ongoing partnership discussions.

Josh Schimmer asked what data from pediatric patients would inform the Phase 2 Danon trial design and if the IMO patient who passed away had unique features. He followed up by asking if younger pediatric patients would have baseline abnormalities amenable to improvement.

Answer

CEO Gaurav Shah said they need to see confirmation of benefit in pediatrics and will use natural history data to inform the Phase 2 design. CMO Jonathan Schwartz noted that while the IMO patient had no specific high-risk identifiers, chronic lung compromise is common in the condition. Shah clarified that pediatric patients enrolled in the trial will have existing signs of cardiac disease (Class 2 heart failure or higher).

Josh Schimmer of Evercore ISI inquired about the status of discussions with the FDA regarding a potential accelerated approval for Molgradex in aPAP based on the IMPALA data. He also asked about non-microbiological outcomes in the NTM study, such as weight loss, and the balance between efficacy and the risk of exacerbations in that indication.

Answer

Chief Medical Officer Badrul Chowdhury explained that the company made a strategic decision to conduct a second Phase 3 study (IMPALA 2) rather than seek accelerated approval, citing internal priorities and shortcomings in the initial IMPALA data. Chief Operating Officer Taneli Jouhikainen added that for the NTM study, there were no clear average improvements in secondary endpoints like weight loss, and it was difficult to assess exacerbation rates in the open-label study, though individual cases would be reviewed.