Allogene Therapeutics Q3 2024 Financial Results and Business Update

Allogene Therapeutics, a clinical-stage biotechnology company based in South San Francisco, focuses on developing allogeneic CAR T-cell products for cancer and autoimmune diseases. On November 7, 2024, the company provided updates on its clinical trials and financial results for the quarter ending September 30, 2024. Key highlights include progress in their pivotal Phase 2 ALPHA3 trial for large B-cell lymphoma (LBCL), pre-clinical data for ALLO-329 in autoimmune diseases, and positive Phase 1 data for ALLO-316 in renal cell carcinoma (RCC).

**Cemacabtagene Ansegedleucel (Cema-Cel):**
The ALPHA3 trial, initiated in June 2024, focuses on patients with minimal residual disease after first-line treatment for LBCL. This trial is groundbreaking as it integrates CAR T therapy into the first-line consolidation for high-risk patients. Approximately 240 patients will be enrolled, and the trial aims to demonstrate significant improvements in event-free survival (EFS) compared to current standard care. Enrollment is set to complete in the first half of 2026, with primary EFS data expected by the end of 2026. A potential Biologics License Application (BLA) submission is targeted for 2027.

**ALLO-329 in Autoimmune Disease (AID):**
ALLO-329 is a next-generation investigational product designed to address both B-cell and T-cell dysfunctions implicated in autoimmune diseases. It utilizes CRISPR-based integration and Dagger® technology to potentially reduce or eliminate the need for lymphodepletion, which is significant for broader CAR T therapy adoption. Pre-clinical data will be presented at the American College of Rheumatology’s annual meeting in November 2024. An Investigational New Drug (IND) application is planned for the first quarter of 2025, with proof-of-concept data expected by the end of 2025.

**ALLO-316 in Renal Cell Carcinoma (RCC):**
The Phase 1 TRAVERSE trial for ALLO-316, targeting advanced or metastatic RCC, has shown promising results. Data presented at the International Kidney Cancer Symposium and the Society for Immunotherapy of Cancer's Annual Meeting indicate that ALLO-316, following standard lymphodepletion, achieved a 50% overall response rate and a 33% confirmed response rate in patients with high CD70 tumor proportion scores. The trial also highlighted the safety profile and the effectiveness of a new diagnostic and management algorithm in mitigating immune effector cell-associated hemophagocytic syndrome (IEC-HS) while preserving CAR T efficacy. The FDA recently granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316, recognizing its potential to address unmet needs in RCC treatment.

**Financial Outcomes:**
For the third quarter of 2024, Allogene reported research and development expenses of $44.7 million and general and administrative expenses of $16.3 million. The net loss for the quarter was $66.3 million. The company ended the quarter with $403.4 million in cash, cash equivalents, and investments, projecting sufficient funds to support operations into the second half of 2026.

Allogene’s continuous efforts in developing innovative therapies for cancer and autoimmune diseases reflect their commitment to advancing treatment paradigms and improving patient outcomes. The company remains focused on progressing its clinical programs and achieving significant milestones in the coming years.