Allogene Therapeutics, Inc. Q3 FY2024 earnings call

• In heme malignancy, advanced the pivotal Phase II ALPHA3 trial of cema-cel for large B cell lymphoma, with 27 of 50 planned sites activated since June, including 60% at community centers.
• Solid tumors: ALLO-316 showed 50% best overall response rate and 33% confirmed response rate in heavily pretreated patients with high CD70 expression in Phase 1 TRAVERSE trial for renal cell carcinoma, earning RMAT designation from FDA.
• Pipeline innovation in autoimmune diseases: ALLO-329, a dual CD19/CD70 CAR, with proprietary Dagger Technology, anticipating IND filing in first quarter 2025 and proof-of-concept data by year end 2025, with preclinical data to be presented at American College of Rheumatology Convergence.
• Recognized exceptional clinical team navigating complex landscape to activate trial sites.
• Highlighted cash balance as of end of Q3 2024 was $403.4 million, cash runway extends into second half of 2026.

No detailed product segment financial performance with revenue contribution provided in the transcript.

• Expect cash burn of approximately $200 million in 2024.
• Full year 2024 GAAP operating expenses expected to be approximately $300 million, including estimated non-cash stock-based compensation expense of approximately $60 million.
• Forward-looking statements regarding success and timing of clinical trials, regulatory filings, future R&D efforts, etc., based on current info, assumptions, and expectations subject to change.

Potential risks detailed in press release and latest SEC disclosure documents, including those related to forward-looking statements, clinical trial outcomes, regulatory approvals, etc.

Q: On the RCC data, when might be done with expansion cohort and start pivotal for approval? And on read throughs of 316 data to 329 autoimmune program.

A: David referred to Zach to answer. Zach said aiming for ~20 patients in expansion cohort, expect program update next year. Encouraged by Dagger effect in 316 program, selected Phase 1b expansion lymphodepletion regimen without ALLO-647, high confidence carrying over to 329 program, noting differences in patient population and indication between RCC and autoimmune.

Q: Grade 5 events in 316 data, confounding effects, and how IECHS management algorithm is implemented.

A: David said adverse events in 316 confounded by underlying disease and trial factors. Zach said IECHS management algorithm analogous to CRS and ICANS, two-step process monitoring signs/symptoms and lab values, instituting first-line therapy and escalating if no rapid response, easy to implement.

Q: On first line lymphoma study, screening rate for MRD positivity, execution, enrollment pace; and on autoimmune, CAR T vs T cell engagers.

A: David talked about autoimmune opportunities, off-the-shelf convenience, once-and-done aspect of allogeneic CAR T. Zach said enthusiasm from clinical trial sites, early activation of community sites, encouraging launch of trial.

Q: On ALLO-316, difference in FC vs CFA lymphodepletion, and what looking for in Phase 1b expansion cohort data for regulatory path.

A: David said small numbers, not much to read into difference between FC and CFA. Zach said aiming for 20 patients in Phase 1b regimen, currently numerically better response rates than third-line options, waiting for durability data.

Q: On ALPHA2 study in CLL cohort, and durability in 316 for RCC.

A: David said CLL study ongoing, prioritizing programs with ALPHA3 in frontline consolidation as top priority. Zach said FDA RMAT designation, low bar for durability in RCC, ongoing deep partial remissions in patients treated with Phase 1b regimen.

Q: On breaking pathological B cell and T cell response in autoimmune disease with product, and on RCC tumor infiltration and response types.

A: David talked about interaction between lymphocytes, B cell depletion, naive phenotype, Dagger Technology allowing minimum lymphodepletion. Zach said yes to tumor aspirates/biopsies showing ALLO-316 infiltrating tumor microenvironment, one complete metabolic remission that deepened to complete remission but patient expired from COVID.

Q: On safety data for ALLO-316, rationale for grade 5 events and translation to autoimmune program.

A: David said safety findings carefully monitored, poster to have more details, Dagger Technology enhances pharmacodynamic effect, part of Phase 1 study for ALLO-329.

Q: On patient retention efforts in ALPHA3, and physician interest in ALPHA3 trial.

A: David said patients in ALPHA3 get best standard-of-care, primary endpoint is event-free survival. Zach said enthusiasm for ALPHA3 high, similar to early ZUMA-1 trial days, physicians recognize potential paradigm shift, enthusiasm from community and academic sites due to MRD tool, off-the-shelf therapy, community access.

Q: On enrollment in autoimmune Phase 1 and maneuvering headwinds.

A: David said enrollment in autoimmune studies picking up, allogeneic CAR T takes away logistic complexity, hopeful to execute studies smoothly.