On May 5, 2021 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 March 31, 2021 (Press release, Allogene, MAY 5, 2021, View Source [SID1234579206]).
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"We’ve had a strong start to the year as evidenced by the significant clinical and regulatory progress made across our growing AlloCAR T portfolio, including the start of our first solid tumors study," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "We believe our progress demonstrates our ability to advance the field of allogeneic CAR T cell therapy and we look forward to sharing data from our CD19 program on May 19th during our virtual forum event."
Pipeline Highlights
Anti-CD19 Program
Updated data from the dose escalation Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) will be jointly presented with initial data from the ALPHA2 study of ALLO-501A at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The presentation will include longer-term follow-up from the initial cohort of patients reported at ASCO (Free ASCO Whitepaper) 2020, additional data on patients treated subsequent to ASCO (Free ASCO Whitepaper) 2020, dose escalation data from ALPHA2, and initial results from patients treated with consolidation dosing of ALLO-501 and ALLO-501A. A separate poster presentation will detail safety and biomarker findings from ALLO-647, Allogene’s wholly owned antibody used for lymphodepletion with fludarabine (Flu)/cyclophosphamide (Cy) in patients with relapsed/refractory NHL and multiple myeloma.
Subject to further study progress and data, the Company plans to initiate a potentially pivotal Phase 2 trial of ALLO-501A by the end of 2021.
On May 19, 2021, the Company will host a virtual CD19 Forum focused on clinical data being presented at ASCO (Free ASCO Whitepaper), along with the Company’s vision for the future of CAR T therapy. In addition to presentations from Company management, the Forum will include a discussion with clinical investigators.
Anti-BCMA Program
The Company continues to execute on its portfolio of anti-B cell maturation antigen (BCMA) therapies in patients with multiple myeloma (MM).
ALLO-715 UNIVERSAL Trial
The U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715, Allogene’s most advanced AlloCAR T candidate for relapsed/refractory MM. The designation follows proof-of-concept data from the Phase 1 UNIVERSAL trial in heavily pretreated, relapsed/refractory MM patients, which demonstrated for the first time that an allogeneic CAR T therapy directed at BCMA can achieve clinical responses while eliminating the need for bridging therapy or delays in treatment associated with manufacturing.
Patient dosing has begun in the portion of the UNIVERSAL trial investigating ALLO-715 in combination with nirogacestat in patients with relapsed/refractory MM. Nirogacestat is an investigational gamma secretase inhibitor being developed by SpringWorks Therapeutics.
ALLO-605 TurboCAR IGNITE Trial
The FDA cleared the Investigational New Drug (IND) application to evaluate ALLO-605, the first TurboCAR T cell therapy, for use in relapsed/refractory MM. TurboCAR technology allows cytokine activation signaling to be engineered selectively into CAR T cells to potentially improve efficacy, overcome exhaustion, and reduce cell dose requirements. The Phase 1 IGNITE trial will evaluate escalating doses of ALLO-605 beginning in mid-2021.
Solid Tumor Program
ALLO-316 TRAVERSE Trial
Patient dosing has begun in the Phase 1 TRAVERSE trial examining safety, tolerability, anti-tumor efficacy, pharmacokinetics and pharmacodynamics of ALLO-316, Allogene’s first CAR T candidate for solid tumors, in patients with advanced or metastatic clear cell renal cell carcinoma.
Expanded TurboCAR Platform
In April 2021, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, the Company reported on pre-clinical data that expands the TurboCAR technology platform to address the biology of solid tumor oncology. TurboCARs were engineered to confer cytokine signaling that is inducible upon binding to PDL1 in the tumor microenvironment or when stimulated with an anti-PD1 antibody while acting as a dominant negative for PDL1 and PDL2 immunosuppressive signaling. These TurboCARs are designed to overcome the challenges in solid tumors associated with an immuno-suppressive tumor microenvironment (TME) by turning negative signals into positive signals.
First Quarter Financial Results
Research and development expenses were $55.2 million for the first quarter of 2021, which includes $7.9 million of non-cash stock-based compensation expense.
General and administrative expenses were $16.4 million for the first quarter of 2021, which includes $8.9 million of non-cash stock-based compensation expense.
Net loss for the first quarter of 2021 was $33.0 million, or $0.25 per share, including non-cash stock-based compensation expense of $16.8 million.
The Company had $964.2 million in cash, cash equivalents, and investments as of March 31, 2021.
2021 Financial Guidance
Allogene continues to expect full year GAAP Operating Expenses to be between $300 million and $330 million including estimated non-cash stock-based compensation expense of $80 million to $90 million and excluding any impact from potential new business development activities.
Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. 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 9435559. 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.
Virtual CD19 Forum
Additional information on the Company’s May 19 Virtual CD19 Forum will be made available in a separate press release and on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Materials presented will be available on the Allogene website prior to the start of the event.