Analyst Conference Summary

biotechnology

conference date: May 13, 2024
for quarter ending: March 31, 2024 (first quarter, Q1)

Forward-looking statements

Overview: continues clinical trials.

Basic data (GAAP):

Revenue was $0, flat sequentially and flat from year-earlier.

GAAP Net Income was negative $65 million, up sequentially from negative $85.8 million, and up from negative $100 million year-earlier.

GAAP EPS was negative $0.38 , sequentially from negative $0.51, and up from negative $0.69 year-earlier.

Guidance:

Cash runway to Q3 2026. 2024 cash burn about $200 million.

Conference Highlights:

David Chang, CEO said "We are very proud of the progress we've made across our portfolio, in particular the transformative potential of our pivotal ALPHA3 trial with cema-cel which is expected to readout in 2026. Securing the EU and UK rights reinforces our conviction in the cema-cel program."

Cema-Cel (ALLO-501A or cemacabtagene ansegedleucel) for large B cell lymphona (LBCL) is preparing for a pivotal Phase 2 study, Alpha3 for first line treatment for patients likely to relaspse following immunotherapy. Cema-Cel is an allogeneic cell therapy. 250 MRD positive patients to get Cema-Cel or current standard of care. EFS primary endpoint. Could begin mid-2024. Consolidated rights (from Servier) to the therapy to EU member states and U.K. and to R/R Chronic Lymphocytic Leukemia; financial terms were favorable, slight increases in milestones and royalties. Believes the market opportunity has expanded to more than $9.5 billion. Could make a BLA submission in 2027.

Cema-cel is also enrolling a Phase 1 trial in r/r CLL (chronic lymphocytic leukemia). An initial readout could occur by the end of 2024.

ALLO-329 for autoimmune disease could enter clinical trials in 2025. Plans to target both CD19 and CD70. Has Dagger technology to eliminate lymphodepletion.

ALL-316 is in a Phase 1 trial for Renal Cell Carcinoma with an early data readout planned for late in 2024. Was awarded a $15 million grant from California Institure for Regenerative Medicine to support the ongoing RCC trial.

Announced a Q2 $110 million common stock offering.

Total operating expenses (GAAP) were $69.5 million, consisting of: R&D $52 million; G&A $17 million; impairment $0 million. Loss from operations was $69.5 million. Other expense net $4.5 million.

Cash and equivalents ended at $397 million, down sequentially from $449 million.

Q&A selective summary:

Phase 3 (WM; ? Alpha3) consolidation enrollment? High interest in program. About 50 clinical trial sites. Could activate first batch of sites by midyear.

Alpha3, why would patients not choose to enroll? The concept of MRD has not made its way into the consciousness of the patient population, but it has for the investigators. We believe patients will be looking for an MRD negative result (following RCHOP). If they are MRD positive, Cema-Cel makes sense, there is nothing else recommended.

Clinical bar for results? We think the bar is quite low and the need is high. Benefits tend to accrue quickly.

EU commercialization plan? Excited about EU. Early, could be a partnership. Our facility in the U.S. can ship to Europe for clinical studies.

Autoimmune lymphodepletion key factors? Data indicates the Dagger technology allows allogenic T cells to expand exceptionally well. Nobody believes persistence is required. We believe this is critical to resetting the system.

We will look at MRD clearnce as an exploratory endpoint, but it is too early to make it a key secondary endpoint.

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