Allogene Pauses Cema-Cel Trial Enrollment, Prioritizes Other Programs
Key Insights
Allogene Therapeutics halts new patient enrollment in the Phase 1 ALPHA2 study of cema-cel for relapsed/refractory Chronic Lymphocytic Leukemia (search) (r/r CLL) due to slow enrollment.
Piper Sandler reduces Allogene's price target to $9, excluding cema-cel revenue in CLL from its valuation model, while maintaining an Overweight rating.
Allogene will focus on the ALPHA3 trial for Large B-Cell Lymphoma (search) (LBCL) and autoimmune programs, with proof-of-concept data expected by the end of 2025.
Allogene Therapeutics has announced a halt to new patient enrollment in the Phase 1 cohort of its ALPHA2 study, which is evaluating cema-cel (cemacabtagene ansegedleucel) for patients with relapsed or refractory Chronic Lymphocytic Leukemia (search) (r/r CLL). The company cited a slower-than-anticipated rate of enrollment as the primary reason for this decision. This strategic shift allows Allogene to focus on other promising areas of its pipeline.
Impact on Financial Outlook
Piper Sandler has adjusted its financial outlook for Allogene, reducing the stock's price target to $9 from the previous $11, while maintaining an Overweight rating. This adjustment reflects the exclusion of potential revenue from cema-cel in CLL in both the U.S. and European markets from its valuation model. Analysts had previously anticipated that cema-cel could outperform similar treatments like Breyanzi due to its allogeneic approach, which could mitigate issues faced by autologous CAR T therapies in CLL patients.
Prioritizing Key Programs
The firm believes that this strategic shift will allow Allogene to focus on more promising areas of its pipeline. These include the ALPHA3 trial for post-first-line treatment of Large B-Cell Lymphoma (search) (LBCL) and its autoimmune programs, with proof-of-concept data expected by the end of 2025. Allogene's commitment to optimizing the use of its resources and its focus on developing innovative therapies is reflected in this decision.
Progress in Other Clinical Trials
Despite the pause in the ALPHA2 study, Allogene has made significant progress in its other clinical trials. H.C. Wainwright maintained a Buy rating on Allogene, following encouraging data from the TRAVERSE trial, which showed a 38% objective response rate for ALLO-316 in treating adult patients with CD70 (search)+ advanced renal cell carcinoma (search). Furthermore, ALLO-316 has demonstrated a 50% best overall response rate in renal cell carcinoma patients.
Financial Stability
Despite a net loss of $66.3 million in the third quarter of 2024, Allogene maintains a robust cash balance of $403.4 million. The company expects its cash runway to extend into the second half of 2026. The ALPHA3 trial for cema-cel, targeting large B cell lymphoma, is advancing with over half of the sites activated. An IND filing for ALLO-329, targeting autoimmune diseases, is expected in Q1 2025.
InvestingPro Insights
Recent InvestingPro data provides additional context to Allogene Therapeutics' current financial situation and market performance. Despite the setback in the ALPHA2 study, the company's stock has shown resilience, with a strong 20.89% return over the last three months. This suggests that investors may be focusing on other aspects of Allogene's pipeline, aligning with Piper Sandler's view on the potential of the ALPHA3 trial and autoimmune programs. Allogene "holds more cash than debt on its balance sheet," which provides some financial flexibility as the company navigates its pipeline priorities.