Allogene Therapeutics, Inc. (ALLO) 10-Q Quarterly Report August 2020

•Initial Phase 1 Results from the ALLO-501 ALPHA Trial at ASCO Demonstrated an Overall Response Rate of 75% and Complete Response Rate of 44% in CAR T Naïve Relapsed/Refractory Non-Hodgkin Lymphoma Patients

•In the ALPHA Trial, Higher Dose ALLO-647 was Associated with Deeper Lymphodepletion, Delayed Host T Cell Recovery and a Higher Complete Response Rate

•Initiated Phase 1 Portion of ALPHA2 Trial for ALLO-501A, a Next-Generation anti-CD19 AlloCAR T^™ Intended for Phase 2 Development

•Completed Initial Dose Escalation Portion of the Phase 1 ALLO-715 UNIVERSAL Trial in Relapsed/Refractory Multiple Myeloma with Data Expected in Q4 2020

•Investigational New Drug (IND) Application to Evaluate ALLO-316, an anti-CD70 AlloCAR T in Renal Cell Carcinoma Expected by Year End

•cGMP Production in Newark Manufacturing Facility On Track for 2021

•Ended Second Quarter with $1.1 Billion in Cash, Cash Equivalents and Investments

•Conference Call and Webcast Scheduled for 5:30 AM PT/8:30 AM ET

SOUTH SAN FRANCISCO, Calif., August 5, 2020 – Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today provided a corporate update and reported financial results for the quarter ended June 30, 2020.

"We are incredibly pleased with the progress we’ve made across our AlloCAR T platform, which now includes ongoing clinical trials for ALLO-501, ALLO-501A and ALLO-715," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "The ALLO-501 data we presented at ASCO in May solidifies our belief in the potential of AlloCAR T therapy in hematologic malignancies. We look forward to presenting initial data in a second hematologic malignancy, multiple myeloma, later this year as we advance the same innovative approach to solid tumors in 2021."

Recent Highlights

Anti-CD19 AlloCAR T Program

Initial data from ALLO-501’s ALPHA trial provided support for the Company’s approach to AlloCAR T therapy. Allogene intends to leverage ALLO-501 to optimize trial design and dose selection as it prepares for a potentially pivotal Phase 2 trial of ALLO-501A in 2021.

•ALLO-501 ALPHA Phase 1 Trial

In May 2020 at the American Society of Clinical Oncology (ASCO) annual meeting, the Company presented initial data from its dose escalation Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL). This study utilizes ALLO-647, the Company’s anti-CD52 monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen. The next readout from this trial is expected to be in late 2020 or early 2021.

As per the ASCO presentation, 22 patients were evaluable for safety and 19 patients were evaluable for efficacy with at least one tumor assessment as of the May 2020 data cutoff.

◦Responses were observed across all cell doses and NHL histologies (diffuse large B-cell lymphoma and follicular lymphoma).

◦Across all evaluable patients, there were seven complete responses (CR) and five partial responses (PR) for an overall response rate (ORR) of 63% and CR rate of 37%.

◦In CAR T naïve patients (n=16) the ORR was 75% and the CR rate 44%.

◦Higher dose ALLO-647 was associated with a higher CR rate.

◦With a median follow-up of 3.8 months, nine of the 12 responding patients (75%) remained in response as of the data cutoff on May 11, 2020.

◦No dose limiting toxicities, graft-vs-host disease, or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) was observed. Cytokine release syndrome occurred in 32% of the patients, was mainly mild to moderate

The following information was filed by Allogene Therapeutics, Inc. (ALLO) on Wednesday, August 5, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

Allogene Therapeutics, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 10.1: Material Contract

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: ALLO
CIK: 1737287
Form Type: 10-Q Quarterly Report
Accession Number: 0001737287-20-000047
Submitted to the SEC: Wed Aug 05 2020 7:48:31 AM EST
Accepted by the SEC: Wed Aug 05 2020
Period: Tuesday, June 30, 2020
Industry: Biological Products No Disgnostic Substances

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Allogene Therapeutics, Inc. (ALLO) SEC Filing 10-Q Quarterly report for the period ending Tuesday, June 30, 2020

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