Gum-Ming Lowe

Gum-Ming Lowe from Craig-Hallum Capital Group requested more detail on the advantages of the two new proprietary surgical devices Roche is evaluating for the OpRegen program.

Answer

CEO Brian Culley detailed that one device, a dual lumen injector, simplifies the procedure to a single retinotomy, while the other, a next-gen Orbit SDS, avoids a retinotomy altogether. He explained these advancements are intended to make the surgery easier and safer, thereby creating a more compelling product profile and widening the competitive moat.

Gum-Ming Lowe of Craig-Hallum asked what preparations Lineage would need to undertake on the manufacturing side if Roche were to start a new controlled study for OpRegen. He also inquired about the rationale for including chronic spinal cord injury patients in the OPC1 program and any known differences in response from prior studies.

Answer

CEO Brian Culley stated that no special manufacturing preparations would be necessary, as Lineage's current production scale is already sufficient to supply even a large clinical trial. For OPC1, he explained that chronic patients are ideal candidates because their neurological function has stabilized, meaning any improvement following therapy would provide a clearer efficacy signal compared to subacute patients who have a variable natural recovery trajectory.

Gum-Ming Lowe of Craig-Hallum Capital Group inquired about the status of the photoreceptor program, the exploratory endpoints for the OPC1 DOSED study, and whether the planned commercial-scale manufacturing milestone would be an in-house achievement.

Answer

CEO Brian Culley clarified that the photoreceptor program is a lower priority with minimal current capital allocation. For the OPC1 study, he noted the FDA insisted on collecting efficacy and quality-of-life data, even in chronic injury patients, which is very exciting. He confirmed the commercial-scale manufacturing milestone is a significant in-house effort to demonstrate a complete, scalable process from master cell bank to final product, a major differentiator in the allogeneic field.

Gum-Ming Lowe (Albert Lowe) asked if the trial extension introduced other design changes, specifically regarding the 13-week follow-up period, and inquired about efficacy expectations for the 52-week time point.

Answer

Executive Puneet Arora confirmed that a 13-week follow-up period will still occur after the full 52-week treatment period for patients who roll over into the extension. President and CEO Punit Dhillon reiterated the 26-week goal of showing a significant weight loss difference but declined to speculate on a specific 52-week target. He expressed hope that the data curves at 26 weeks will indicate a trajectory for continued, deeper weight loss, consistent with historical data for the drug class.

Gum-Ming Lowe asked for theories on whether nimacimab's unique mechanism of action could be responsible for its well-tolerated profile, particularly the low rate of gastrointestinal (GI) adverse events.

Answer

Executive Christopher Twitty suggested the favorable profile may be due to the modality difference, with an antibody's high specificity contrasting with a small molecule, but acknowledged there is no definitive answer. Chief Medical Officer Dr. Puneet Arora added that GI issues with GLP-1s stem from both peripheral and central actions. He agreed that nimacimab's nature as an antibody likely contributes to its better tolerability, though the precise mechanisms are still being understood.

Gum-Ming Lowe from Craig-Hallum asked if the data update in the first half of 2025 would include results from all 90 evaluable patients, given that trial enrollment was expected to be completed within a few weeks.

Answer

Executive Mark Erlander expressed excitement about completing enrollment but did not commit to including all 90 patients in the next update. He reiterated that the primary goal for the first-half 2025 data release is to ensure it is a substantive and more mature update compared to the initial data cut from 30 patients.