Allogene Therapeutics, Inc. (ALLO) 10-K Annual Report February 2020

•Initial Results from the Phase 1 ALLO-501 ALPHA Trial in Relapsed/Refractory Non-Hodgkin Lymphoma and Phase 1 ALLO-715 UNIVERSAL Trial in Relapsed/Refractory Multiple Myeloma On-Track for Q2 2020 and Q4 2020, Respectively

•ALLO-501A, the Next Generation anti-CD19 AlloCAR T Intended for Phase 2 Development, Received IND Clearance from the U.S. FDA. Company Expects to Initiate an Abbreviated Phase 1 Trial in Q2 2020

•Combination Trial of ALLO-715 and SpringWorks Therapeutics’ Gamma Secretase Inhibitor, Nirogacestat, Expected to Commence in the Second Half of 2020

•IND Submission for Next Clinical Candidate, ALLO-316, an anti-CD70 AlloCAR T^TM,Targeted for Year End 2020

•Ended 2019 with $589 Million in Cash, Cash Equivalents and Investments

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

SOUTH SAN FRANCISCO, Calif., February 27, 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 fourth quarter and full-year 2019 financial results for the periods ended December 31, 2019.

"2019 was a very successful year for Allogene. We accomplished all of our corporate goals, which includes the establishment of world-class capabilities across multiple new functions and the initiation of our first clinical trials in patients with relapsed or refractory aggressive non-Hodgkin lymphoma and multiple myeloma," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Our momentum and focus towards making AlloCAR T therapies and their life-saving potential a reality for patients will continue at full speed in 2020. This year will be an important one as we look to demonstrate proof-of-concept data from two key programs and plan for potential pivotal studies."

Recent Highlights

ALLO-501 (anti-CD19 AlloCAR T)

•In 2019, Allogene initiated the ALLO-501 Phase 1 ALPHA trial in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). This study utilizes ALLO-647, Allogene's anti-CD52 monoclonal antibody (mAb) as a part of the lymphodepletion regimen. Initial data is planned to be presented at a medical meeting in Q2 2020.

•The U.S. Food and Drug Administration cleared the Investigational New Drug Application (IND) for ALLO-501A, the Company’s next generation anti-CD19 AlloCAR T construct devoid of the rituximab off-switch. ALLO-501A, previously referred to as ALLO-501.1, was created to eliminate the rituximab recognition domains in ALLO-501, allowing for use in a broader patient population, including those NHL patients with recent rituximab exposure.

•The Company expects to initiate an abbreviated Phase 1 portion of the ALLO-501A trial (ALPHA2) in the second quarter of the year. The ALPHA2 trial will leverage the findings of the ALPHA trial to finalize the ALLO-501A cell dose and the ALLO-647 based lymphodepletion regimen for a potential pivotal Phase 2 trial.

ALLO-715 (anti-BCMA AlloCAR T)

•The Company has created a robust anti-BCMA strategy centered around ALLO-715 for the treatment of multiple myeloma (MM).

•In 2019, Allogene initiated the ALLO-715 Phase 1 UNIVERSAL trial in patients with relapsed/refractory MM, designed to assess the safety and tolerability of ALLO-715. This trial is also intended to identify the optimal dose of ALLO-647 and includes the potential to evaluate lymphodepletion regimens that do not include fludarabine and cyclophosphamide. UNIVERSAL continues to accrue as planned with initial data anticipated in Q4 2020.

•In January 2020, Allogene entered into a clinical collaboration with SpringWorks Therapeutics to evaluate ALLO-715 in combination with SpringWorks’ investigational gamma secretase inhibitor, nirogacestat, in patients with relapsed/refractory MM. The Company expects to initiate this combination trial in the second half of 2020.

•The Company nominated ALLO-605 as its first TurboCAR^TM candidate and part of its larger MM strategy. The TurboCAR technology provides the effects of cytokine stimulation to AlloCAR T cells with the goal of enhancing

The following information was filed by Allogene Therapeutics, Inc. (ALLO) on Thursday, February 27, 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-K Annual 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-K Annual Report

Material Contracts, Statements, Certifications & more

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

Exhibit 4.3: Instruments Defining The Rights Of Security Holders, Including Indentures

Exhibit 10.7: Material Contract

Exhibit 10.11: Material Contract

Exhibit 10.15: Material Contract

Exhibit 23.1: Consents Of Experts And Counsel

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

Exhibit 32.2: Section 1350 Certification

Ticker: ALLO
CIK: 1737287
Form Type: 10-K Annual Report
Accession Number: 0001737287-20-000012
Submitted to the SEC: Thu Feb 27 2020 4:07:08 PM EST
Accepted by the SEC: Thu Feb 27 2020
Period: Tuesday, December 31, 2019
Industry: Biological Products No Disgnostic Substances

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Allogene Therapeutics, Inc. (ALLO) SEC Filing 10-K Annual report for the fiscal year ending Tuesday, December 31, 2019

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