Shelby Tucker

Shelby Tucker, on for Luca Aci at RBC Capital Markets, questioned if the recent patient death in the first-line setting could materially slow trial enrollment, given the patient population is perceived as relatively stable.

Answer

CMO Dr. Zachary Roberts countered that MRD-positive patients have chemo-refractory cancer and are at high risk of progression, a view shared by investigators. He explained the unfortunate event prompted a safety and efficacy review that ultimately gave the team, DSMB, and FDA confidence that moving forward with the standard FC arm provides the appropriate benefit-risk profile.

Shelby Tucker, on behalf of Luca Issi from RBC Capital Markets, asked if the decision for inpatient versus outpatient treatment in the ALPHA3 trial is at the investigator's discretion and what the expected mix might be.

Answer

Dr. Zachary Roberts, EVP of R&D and CMO, confirmed the decision is entirely up to the investigator, noting a significant number of patients are already treated as outpatients. Dr. David Chang, CEO, added that this flexibility is a key feature, as not requiring hospitalization makes the trial more like standard cancer care.

Speaking for Luca Issi, Shelby Tucker of RBC Capital Markets asked about plans to file data on treating the fellow eye in wet AMD and whether the initial label for RGX-314 would reflect bilateral dosing.

Answer

Chief Medical Officer Dr. Steve Pakola confirmed that the ability to treat both eyes was prospectively addressed with the FDA. He stated that their safer, compartmentalized delivery routes are more amenable to bilateral treatment and that it is their intent to include the fellow eye data in the regulatory filing to inform clinicians on this use.

Shelby Tucker inquired about the breakdown of Unitil's capital spending program between its Electric and Gas assets and the expected future trend in spending allocation, considering state policies.

Answer

Chairman and CEO Tom Meissner explained that capital investment is shifting towards the electric business, driven by state policies like grid modernization in Massachusetts and New Hampshire, and the near completion of gas pipeline replacement programs. SVP, CFO, and Treasurer Daniel Hurstak added that while the current rate base is roughly two-thirds gas, the investment mix will trend more toward electric. Hurstak also confirmed there is unstated upside to the capital plan from electric sector modernization investments not yet included in the $910 million forecast.

Shelby Tucker inquired about the breakdown of Unitil's capital spending program between its Electric and Gas assets and asked about future spending trends in light of evolving state policies and potential upside to the rate base growth target.

Answer

Chairman and CEO Tom Meissner confirmed a strategic shift in capital investment towards electric, driven by grid modernization policies, particularly in Massachusetts. He noted that gas pipeline replacement programs are nearing completion, which will naturally pivot spending. SVP and CFO Daniel Hurstak added that while the current rate base is approximately two-thirds gas, the investment mix will trend more toward electric. Both executives confirmed there is unstated upside to the capital plan from Massachusetts' electric sector modernization and the pending Bangor Natural Gas acquisition.