Greg Harrison

Speaking on behalf of Greg Harrison, an analyst from Scotiabank asked about the competitive landscape for wet AMD therapies and the advantage EyePoint gains from being first-to-market.

Answer

CEO Dr. Jay Duker acknowledged that in a large market, multiple competitors with a new mechanism of action can be additive. However, he emphasized that first-mover advantage is critical, and when combined with a favorable six-month label, ease of use, and a strong safety profile, he is confident EyePoint will be positioned as the leader in sustained-release retinal therapies.

Joe Thomas on behalf of Greg Harrison at Scotiabank asked about the competitive advantage EyePoint gains from being first to market, particularly now that a competitor's second trial readout is delayed to 2027.

Answer

CEO Jay Duker emphasized that while having multiple companies in the TKI space is additive for a large market, the first-mover advantage is 'really important.' He stressed that EyePoint's competitive edge is a full package, including not just timing but also a likely six-month dosing label, ease of use, and a strong safety profile, which together position the company to be the leader in sustained-release retinal therapies.

Joe, on behalf of Greg Harrison, asked about the possibility of a rolling NDA submission given the different readout timelines for LUGANO and LUCIA, and how this might affect the data release strategy.

Answer

President and CEO Dr. Jay Duker clarified that the final NDA submission is limited by the last patient visit in the second trial, LUCIA. Chief Medical Officer Dr. Ramiro Ribeiro added that having the LUGANO data earlier will create internal efficiencies, allowing the team to accelerate analysis and writing in preparation for the final submission.

Joe, on behalf of Greg Harrison at Scotiabank, asked about the potential for a rolling NDA submission given the different enrollment rates of the two trials and how that might affect the data release strategy.

Answer

CEO Dr. Jay Duker explained that the NDA submission is limited by the last patient visit in the second trial (LUCIA). However, Chief Medical Officer Dr. Ramiro Ribeiro added that since the LUGANO trial is enrolling faster, they can accelerate the interpretation and analysis for that study. Because the trials are identical, this work will create efficiencies and speed up the process once the second study's data is available.

Greg Harrison asked for details on Geron's European commercialization strategy, including the attributes sought in a potential partner and the likely timing for announcing an agreement.

Answer

Jim Ziegler, EVP & CCO, stated that the top priority is securing favorable reimbursement on a country-by-country basis in the EU. He emphasized a financially disciplined approach, avoiding a large build-out ahead of reimbursement decisions. Geron is actively engaged with potential partners for commercialization in the EU4 and other regions, contingent on achieving strong pricing.

Greg Harrison from Scotiabank asked about the key identified areas for growth for the Atruvio launch and the company's main execution priorities for the remainder of the year.

Answer

CEO Neil Kumar identified continued clinical differentiation through subpopulation data (e.g., AFib), emphasizing the drug's early impact, and improving patient access as primary growth drivers. CCO Matthew Outten added that a key priority is ensuring seamless access for any patient who wants Atruvio, especially as new-to-market insurance edits are resolved.

Greg Harrison from Scotiabank questioned the source of Attruby's strong revenue, asking if it was driven by larger-than-expected market growth or a high percentage of patients switching from Tafamidis, and how that trend might evolve.

Answer

VP of Strategic Finance Chinmay Shukla clarified that the launch focus remains on the treatment-naive market, though they saw more switches than expected initially. He attributed the strong revenue to a combination of market growth, high demand, and strong conversion rates. CCO Matt Outten added that while identifying switch patients is difficult, the overall market continues to grow at a double-digit rate, and they are optimistic about capturing both new and switch patients.

An analyst on behalf of Greg Harrison from RBC Capital Markets asked how the upcoming LOTIS-7 data at EHA and ICML would set the stage for the subsequent data release from the 40-patient expansion arm. He also requested details on what to expect from the LOTIS-5 presentation, including any key efficacy benchmarks.

Answer

CMO Mohamed Zaki responded that the LOTIS-7 presentation will feature more patients and longer follow-up, while the LOTIS-5 update will provide more detail on the durability of complete responses, which now exceeds two years. CEO Ameet Mallik highlighted that the LOTIS-7 presentation at ICML will be a full oral presentation, implying a comprehensive data review.

Greg Harrison asked for the reasons behind the quarterly revenue decline for EMPAVELI in PNH, questioning if it was due to inventory issues or changes in demand.

Answer

Executive Cedric Francois expressed satisfaction with EMPAVELI's stable position in PNH despite an oral competitor, noting some patients have returned to EMPAVELI after trying the oral drug. Executive Timothy Sullivan attributed the revenue decline to a mix of factors: about one-third from inventory and pricing dynamics, and two-thirds from a small decrease in demand versus the prior year. Executive David Acheson added that patient compliance remains high.

Asked about the timeline for updates on the company's in vivo editing programs, the commercial opportunity for in vivo versus ex vivo therapies, and which other tissues are attractive targets for their technology.

Answer

The company will provide updates on in vivo efforts once they have high-conviction targets. They believe the in vivo commercial opportunity is significantly larger as it eliminates the need for conditioning, expanding the eligible patient pool. They are focused on an in vivo HSC program and are also interested in the liver and other tissues.

Greg Harrison from Bank of America asked for more color on the strategic pivot of imvotamab to autoimmune indications like lupus and RA, and how the encouraging IGM-8444 biomarker data might correlate with clinical response.

Answer

President of Autoimmunity and Inflammation Dr. Mary Beth Harler and Chief Medical Officer Dr. Chris Takimoto detailed the rationale, citing the established CD20 target, a less competitive landscape than NHL, and the potential for deeper B-cell depletion. They noted lupus and RA were chosen for initial proof-of-concept and rapid signal detection. Regarding biomarkers, Dr. Takimoto explained that the caspase-3 increase is a strong indicator of target engagement, but it is too early to draw direct correlations to clinical outcomes.