Analyst Conference Summary

biotechnology

conference date: August 7, 2024 @ 2:00 PM PT
for quarter ending: June 30, 2024 (second quarter, Q2)

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 $66 million, down sequentially from negative $65 million, and flat from negative $66 million year-earlier.

GAAP EPS was negative $0.35, up sequentially from negative $0.38, and up from negative $0.54 year-earlier. Number of Shares increased about 29% from year earlier.

Guidance:

Cash runway to Q3 2026. 2024 cash burn about $200 million, GAAP op ex $300 million.

Conference Highlights:

David Chang, CEO said "The second quarter has been an excellent example of the power of momentum, particularly as we bring into the fold community cancer centers who are eager to be a part of our pivotal Phase 2 ALPHA3 trial and we are now manufacturing all of our CAR T investigational products in-house. Beyond the progress we've seen across our four core programs with cema-cel in blood cancers, ALLO-329 in autoimmune disease, and ALLO-316 in relapsed and refractory renal cell carcinoma, there is renewed energy from investigators, clinical trial sites, and top-tier investors as it becomes increasingly apparent that we have the potential to reshape the future of CAR T therapies." Momentum is on our side. We could potentially change the CAR T landscape. FDA has been supportive.

Cema-Cel (ALLO-501A or cemacabtagene ansegedleucel) for large B cell lymphona (LBCL) began a pivotal Phase 2 study, Alpha3, in June 2024, for first line treatment for patients likely to relaspse following immunotherapy. Patient enrollment rapid so far. Cema-Cel is an allogeneic cell therapy. 250 MRD positive patients to get Cema-Cel or current standard of care. EFS primary endpoint. Believes the market opportunity has expanded to more than $9.5 billion. Data possible in 2026. Could make a BLA submission in 2027. Developing a test for MRD (minimal residual disease), which would predict patients likely to relapse after RCHOP treatment.

Cema-cel is also enrolling a Phase 1 trial in r/r CLL (chronic lymphocytic leukemia). An initial readout could occur in early 2025.

ALLO-329 for autoimmune disease could enter clinical trials in 2025 after an IND in Q1. 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.

Had a Q2 $110 million common stock offering.

Total operating expenses (GAAP) were $71 million, consisting of: R&D $50 million; G&A $16 million; impairment $5 million. Loss from operations was $71 million. Other income net $5 million.

Cash and equivalents ended at $445 million, up sequentially from $397 million.

Q&A selective summary:

Cema-Cel frontline consolidation gating factors for patients? No real alternatives for MRD positive patients. Ours is the only clinical trial open for MRD patients.

Rate of MRD v. expectations? Early. 10 active sites screening. Standard metrics. Will provide more information as we go forward.

ALLO-329? May be some variability, findings so far have not changed our assumptions. Different from all prior treatments. Potential to provide long-term remission after a single infusion. Question is length of that remission. So far, durability is a year or longer.

Site enrollment for Cema-cel? Target population mostly treated in community centers. That guides site selection. Will be adding academic centers.

PFS expectations? Time to event modeled out, it is quite short for observation arm, weeks to months. So interim analysis can be relatively soon.

CLL trial? Secondary priority after LBCL, looking to readout in 2025.

Do community centers lack CAR T experience? Every site, we make sure they have the tools they need. So yes, community centers might need more training than academic centers. Because of our safety profile, the management of side effects is doable. Also, even those who have not used CAR T have used bispecifics and so have seen those side effects.

ALLO-329 for autoimmune advantages? It is not just a B cell disease. Targetting activated T cells is important for maximum potential.

Competitors in CAR T autologous autoimmune diseases? We don't know all the details of the CD19 CAR T manufacturing competition. Proprietary. Could prove to be important. Our manufacturing approach includes CRISPR, which could improve product consistency.

BRL Medicine asset? We share their enthusiasm to CD19 early results. They have strategies for cell expansion and persistence. Other have tried the same strategy. We are relying on the Dagger technology, we believe likely to be better chan cloaking strategies.

We believe anti CD52 antibody is important to persistence in this setting. But with MRD setting may not require that kind of persistence. So we are testing with and without ALLO-647.

329 preclinical data? We hope to share that soon.

Community centers have shied away from offering CAR T because of the cost of putting in the infrastructure to support it.

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