On November 5, 2019 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported financial results for the quarter ended September 30, 2019 (Press release, Allogene, NOV 5, 2019, View Source [SID1234550307]).
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"I am very pleased with the progress we have made in a short period of time. While we leveraged the research from Pfizer to launch Allogene, we have built the company from the ground up. In parallel, we have initiated the build-out of in-house manufacturing capabilities, successfully progressed AlloCAR T programs into Phase 1 clinical development while creating next generation therapies and entering into agreements that will keep us at the forefront of cell therapy," said David Chang, M.D., Ph.D., President, CEO and Co-Founder of Allogene Therapeutics. "With the initiation of our ALLO-715 Phase I UNIVERSAL trial in multiple myeloma, we have achieved all of the clinical goals that we set out for ourselves at the beginning of 2019. I am very proud of our team’s accomplishments and firmly believe that the time and investment Allogene is making in research, next generation technologies, manufacturing and personnel will provide us with the key building blocks needed to support our goal of being the first to bring an AlloCAR T therapy to patients."
Pipeline Highlights
ALLO-501 (anti-CD19 AlloCAR T)
ALLO-501 Phase 1 ALPHA trial in patients with relapsed/refractory non-Hodgkin lymphoma (NHL) continues to accrue as planned with data expected in the first half of 2020.
ALLO-715 (anti-BCMA AlloCAR T)
The Company initiated the ALLO-715 Phase 1 UNIVERSAL trial in patients with relapsed/refractory multiple myeloma (MM).
The Phase 1 ALLO-715 UNIVERSAL trial is designed to assess the safety and tolerability at increasing dose levels of ALLO-715 to identify an optimal dose of ALLO-715 for the potential Phase 2 study. This trial utilizes ALLO-647, the Company’s proprietary anti-CD52 monoclonal antibody, as a part of the lymphodepletion regimen. The UNIVERSAL trial also includes the potential to evaluate alternative lymphodepletion regimens that do not include fludarabine and cyclophosphamide.
ALLO-715 utilizes TALEN gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at the BCMA target. Allogene holds global development and commercial rights for this investigational candidate.
Additional Pipeline Updates
UCART19 (Servier-Sponsored Program in Collaboration with Allogene) – Servier continues to expect that
UCART19, an anti-CD19 AlloCAR T being developed for pediatric and adult relapsed/refractory acute lymphoblastic leukemia (ALL), will advance into potential Phase 2 registrational trials in 2020.
Corporate Highlights
Earlier today, the Company announced a worldwide collaboration with Notch Therapeutics to develop induced Pluripotent Stem Cell (iPSC)-derived allogeneic therapies for hematologic cancer indications.
The Company will receive exclusive rights and targets for initial applications in non-Hodgkin lymphoma, leukemia and multiple myeloma and has made an equity investment in Notch. Notch will receive an upfront payment, research funding, development and commercial milestones, and royalties on net sales.
Notch was established in 2018 by Juan Carlos Zúñiga-Pflücker, Ph.D. and Peter Zandstra, Ph.D., recognized pioneers in iPSC and T cell differentiation technology.
Third Quarter Financial Results
As of September 30, 2019, Allogene had $601.9 million in cash, cash equivalents, and investments.
Research and development expenses were $40.0 million for the third quarter of 2019, which includes $5.5 million of non-cash stock-based compensation expense, compared to $10.9 million for the third quarter of 2018. Research and development expenses also included a $5.0 million milestone to Cellectis that is associated with the initiation of the ALLO-715 UNIVERSAL trial.
General and administrative expenses were $15.0 million for the third quarter of 2019, which includes $7.3 million of non-cash stock-based compensation expense, compared to $11.3 million for the third quarter of 2018.
Net loss for the third quarter of 2019 was $50.7 million, or $0.50 per share, including non-cash stock-based compensation expense of $12.8 million, compared to a net loss of $43.5 million, or $10.71 per share for the third quarter of 2018.
Including expenses associated with the Notch transaction, the Company reiterates full-year 2019 Net Loss guidance of between $200 million and $210 million dollars, which includes an estimated non-cash stock-based compensation expense of $45 to $50 million dollars, and excludes any impact from future business development activities.
Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 5:30 AM Pacific Time/8:30 AM Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 2747063. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.