Aug 12, 2026 earnings call — Expanded ARCHER II endpoints and GBS regulatory progress
Announced adding an independent month 24 dual primary endpoint to the ARCHER II Phase III trial.
EPS $-0.28 (est $-0.24)
Key quotes
"Importantly, the FORWARD data are expected to support our planned Biologics License Application, or BLA, submission to FDA in the fourth quarter of this year."
"Today, we announced a strategic expansion of the program by adding an independent month 24 dual primary endpoint alongside the existing month 15 primary endpoint."
"During the quarter, we entered a credit facility with Oxford Finance that provides access up to $200 million in non-dilutive capital, extending our cash runway into 2028."
Analyst Q&A 8
regulator feedback on month 24 plan
Q (Anupam Rama · JPMorgan): He asked whether the company shared the dual primary endpoint plan with regulators in the U.S. and globally, and what feedback they received.
A: Management said yes. Regulators told them that to include month 24 in the label they must apply alpha to month 24. They also said there is full alignment at month 15 and regulators discussed the importance of month 24.
"The short answer is, yes, both regulators on both sides of the pond have been very clear that if we want to include month 24 in the label, we would need to apply alpha to month 24." — Douglas Love (CEO)
why add month 24; confidence in month 15
Q (Derek Archila · Wells Fargo): He asked what drove the decision to add the 24-month endpoint and whether blinded data raised concern about the 15-month endpoint.
A: Management said they are very confident in month 15 and treat it as the base case. After passing the 12-month point, they saw strong masked event rates, overenrolled by 30 patients, and very low dropouts, which created extra power that they applied to a second time point without weakening month 15.
"So sort of at this halftime evaluation of the study, we found ourselves with increased power." — Lloyd Clark
lesion growth significance at 24 months
Q (Matthew Barcus · Jefferies): They asked whether lesion growth would reach statistical significance by month 24 as a secondary endpoint.
A: Management said lesion growth is less directly linked to vision protection than photoreceptor preservation, so it is not the primary biology for protecting vision. They are encouraged that protecting photoreceptors shows healthier neuronal units and have seen 10% protection in RPE growth in the second 6 months, and they expect protection may reach statistical significance over time.
"But it's not important to protect lesion growth for the purposes of protecting vision." — Douglas Love (CEO)
commercial impact and delayed response concern
Q (Salveen Richter · Goldman Sachs): She asked about the commercial outlook if separation appears at month 15 but is more static at 24 months, and whether any slower time to response would be seen as a delay.
A: Management said they expect to be positive at month 15 and they expect statistical significance at month 24. They argued that this would not be viewed as a delay—no approved drug has done vision preservation faster—and that adding month 24 would let them show efficacy in the label at 2 years, strengthening the overall case for rapid adoption.
"So month 15 is not kind of just kind of a speed bump, look, but we expect stat sig at month 24." — Douglas Love (CEO)
alpha allocation between endpoints
Q (Joseph Stringer · Needham): He asked whether month 15 still carries the full alpha or whether the statistical threshold there tightened after adding month 24.
A: Management confirmed they are splitting alpha between month 15 and month 24. They said execution exceeded base assumptions so the difference at month 15 is negligible and they are using the extra powering to add the second time point without substantively reducing the chance of a month 15 win.
"Yes, right. Obviously, yes, we are splitting alpha between month 15 and month 24." — Lloyd Clark
substudy powering and masked event rates
Q (Ananda Ghosh · H.C. Wainwright): He asked how the substudies are powered and whether the blinded pooled event rates match Phase I/II results and projections.
A: Management said they are splitting alpha but did not disclose the exact split. They said the execution lets them retain Phase III powering at the substudy level and be well overpowered at the combined study, and that masked event rates are on target with projections and consistent with what they saw in Phase II, giving confidence in the month 15 endpoint.
"The first question about powering, yes, we are splitting alpha, and we haven't disclosed specifically what that alpha split is going to be." — Lloyd Clark
Q4 disclosure, powering, and GBS status
Q (Philip Nadeau · TD Cowen): He asked what exactly will be disclosed in Q4 (scenarios, futility stop), whether they will disclose current powering, and if there have been further FDA discussions on GBS and FORWARD requirements.
A: Management said they are in ongoing discussions with the FDA on GBS and feel confident that with FORWARD data they will file a BLA in Q4. For the GA study, the DMC can declare futility, but in Q4 they will disclose whether the overall study is positive at month 15 or will continue to month 24; they have not publicly shared specific powering numbers but said both time points remain conventionally well powered.
"But you will get results on the overall study in Q4 as promised." — Lloyd Clark
DMC data release and event rate projection to month 24
Q (Jonathan Wolleben · Citizens): He asked if DMC data would be publicly released in Q4 if the decision is to continue to month 24, and what the masked event rate looks like and how they model month 24 projections.
A: Management said no patient-level data will be released; the study will remain masked through month 24 and they will then start the substudy analyses. They said they modeled event rates using Phase II data and other longer trials, expect events to continue progressing over several years, and anticipate similar behavior in year 2 as in year 1 based on those models.
"It will be masked all the way through month 24, which is the predesigned setup for that." — Douglas Love (CEO)