On November 4, 2020 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, 2020 (Press release, Allogene, NOV 4, 2020, View Source [SID1234569999]).

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"We continue to see rapid advancement across our pipeline of AlloCAR T candidates and look forward to a number of firsts for Allogene over the coming months, starting with the first look at data from the Phase 1 UNIVERSAL trial of ALLO-715 for the treatment of multiple myeloma. The firsts will continue with the submission of our IND in solid tumors to evaluate ALLO-316 in renal cell carcinoma by the end of the year as well as an IND to evaluate ALLO-715 in combination with nirogacestat," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "In the spirit of leading today and creating tomorrow as we advance allogeneic cell therapies for patients, we look forward to 2021 where we anticipate having five clinical trials underway, including our first pivotal trial."

Pipeline Highlights

Anti-BCMA AlloCAR T Program
The Company continues to execute on a three-pronged anti-BCMA strategy led by ALLO-715, a Phase 1 candidate for the treatment of relapsed/refractory multiple myeloma (MM).

ALLO-715 UNIVERSAL Phase 1 Trial
Initial data from the ALLO-715 Phase 1 UNIVERSAL trial will be presented at a medical meeting in Q4 2020. The UNIVERSAL trial utilizes ALLO-647 (anti-CD52 mAb) together with the standard fludarabine and cyclophosphamide as the lymphodepletion regimen. The initial dose escalation portion of the UNIVERSAL trial studied ALLO-715 dosed at 40M, 120M and 320M cells following lymphodepletion with 39mg (low dose) of ALLO-647. Fifteen patients were treated in the study at the time of abstract submission.
The virtual presentation will include data on approximately 20 patients evaluable for efficacy across ALLO-715 cell dose cohorts and lower dose (39mg) of ALLO-647, as well as patients evaluable for efficacy who were treated with higher doses of ALLO-715 and higher doses of ALLO-647. The Phase 1 UNIVERSAL study continues to enroll patients at these higher doses in an effort to optimize the therapy.
This study is enrolling patients with relapsed/refractory MM who have been treated with at least three prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody (unless contraindicated), and refractory to the last treatment line.
ALLO-715 + nirogacestat
The Company is on track to submit an IND application by the end of 2020 to evaluate ALLO-715 in combination with SpringWorks’ investigational gamma secretase inhibitor, nirogacestat, in patients with relapsed/refractory MM.
ALLO-605 (anti-BCMA TurboCAR)
An IND is expected to be submitted in the first half of 2021 for the Company’s first TurboCAR candidate, ALLO-605, an investigational BCMA-directed AlloCAR T therapy for MM. TurboCAR technology allows cytokine activation signaling to be engineered selectively into CAR T cells. TurboCAR has the potential to improve efficacy, overcome cell exhaustion, and reduce dosing requirements of AlloCAR T therapy.
Anti-CD19 AlloCAR T Program

The Company continues to leverage data from the Phase 1 ALPHA trial of ALLO-501 to inform and optimize trial design and dose selection of ALLO-501A and ALLO-647, a differentiated lymphodepleting agent.
In the first half of 2021, additional data from the Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) and initial data from the Phase 1 dose escalation ALPHA2 study of ALLO-501A are planned for presentation. Data from these trials are expected to support trial design for a potentially pivotal Phase 2 trial planned for initiation in 2021.
Solid Tumor AlloCAR T Program

ALLO-316 (anti-CD70)
The Company expects to submit an IND for ALLO-316, its first AlloCAR T candidate for the treatment of solid tumors, by the end of 2020. A study in renal cell carcinoma is expected to initiate in 2021. ALLO-316 targets CD70 and also has potential application in hematologic malignancies.
Corporate Highlights

Manufacturing
Construction continues on the Company’s state-of-the-art cGMP cell manufacturing facility in Newark, California with cGMP manufacturing from this facility expected in 2021.
Business Development
The Company and The University of Texas MD Anderson Cancer Center announced a strategic five-year collaboration aimed at accelerating the development of a broad portfolio of AlloCAR T candidates across hematologic and solid tumors. Under the agreement, MD Anderson and the Company will collaborate on the design and conduct of preclinical and clinical studies with oversight from a joint steering committee.
Third Quarter Financial Results

Research and development expenses were $51.4 million for the third quarter of 2020, which includes $8.8 million of non-cash stock-based compensation expense.
General and administrative expenses were $16.6 million for the third quarter of 2020, which includes $9.0 million of non-cash stock-based compensation expense.
Net loss for the third quarter of 2020 was $66.2 million, or $0.52 per share, including non-cash stock-based compensation expense of $17.8 million.
The Company had $1.0 billion in cash, cash equivalents, and investments as of September 30, 2020.
2020 Financial Guidance

Allogene continues to expect full year GAAP net losses to be between $260 million and $280 million including estimated non-cash stock-based compensation expense of $70 million to $75 million and excluding any impact from potential business development activities.
Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 5:30 a.m. Pacific Time / 8:30 a.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 2637139. 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