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

Allogene Therapeutics, Inc.

CIK: 1737287 Ticker: ALLO


Exhibit 99.1
g725933allogenea061a.jpg

Allogene Therapeutics Reports Third Quarter 2020 Financial Results

Enrollment Ongoing in Phase 1 Trials of ALLO-501 (ALPHA), ALLO-501A (ALPHA2) and ALLO-715 (UNIVERSAL)
Initial Phase 1 Results from the UNIVERSAL Trial in Relapsed/Refractory Multiple Myeloma to be Presented at a Medical Meeting in Q4 2020
In 1H 2021, Initial ALLO-501A Data and Updated ALLO-501 Results in Non-Hodgkin Lymphoma are Planned in Preparation for a Potential Pivotal Study Initiation of ALLO-501A in 2021
Three Investigational New Drug (IND) Applications to be Submitted; Two in Q4 2020 with ALLO-316, an Anti-CD70 AlloCAR T™, in Renal Cell Carcinoma and ALLO-715 in Combination with Nirogacestat in Relapsed/Refractory Multiple Myeloma, and One in 2021 with ALLO-605, the First TurboCAR™ Targeting BCMA
Ended Third Quarter with $1.0 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., Nov. 4, 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 September 30, 2020.

"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


The following information was filed by Allogene Therapeutics, Inc. (ALLO) on Wednesday, November 4, 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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Inside Allogene Therapeutics, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Cover Page
Condensed Consolidated Balance Sheets
Condensed Consolidated Balance Sheets (Parenthetical)
Condensed Consolidated Statements Of Cash Flows
Condensed Consolidated Statements Of Operations And Comprehensive Loss
Condensed Consolidated Statements Of Stockholders??? Equity
Condensed Consolidated Statements Of Stockholders??? Equity (Parenthetical)
Balance Sheets Components
Balance Sheets Components (Details)
Balance Sheets Components (Tables)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Details)
Commitments And Contingencies - Lease Costs (Details)
Commitments And Contingencies - Lease Liabilities (Details)
Commitments And Contingencies - Undiscounted Future Lease Payments (Details)
Description Of Business
Description Of Business (Details)
Equity Method Investment
Equity Method Investment (Details)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Additional Information (Detail)
Fair Value Measurements - Financial Assets And Liabilities (Detail)
Financial Instruments
Financial Instruments (Tables)
Financial Instruments - Additional Information (Details)
Financial Instruments - Cash Equivalents, Restricted Cash And Investments, Classified As Available-For-Sale Securities (Details)
Income Taxes
License Agreements
License Agreements (Details)
Net Loss Per Share
Net Loss Per Share (Details)
Net Loss Per Share (Tables)
Related Party Transactions
Related Party Transactions (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Details)
Stock-Based Compensation - Expense (Details)
Stock-Based Compensation - Restricted Stock Units Activity (Details)
Stock-Based Compensation - Stock Option Activity (Details)
Stock-Based Compensation - Valuation Assumptions (Details)
Subsequent Events
Subsequent Events (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Details)
Summary Of Significant Accounting Policies (Policies)

Material Contracts, Statements, Certifications & more

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

Ticker: ALLO
CIK: 1737287
Form Type: 10-Q Quarterly Report
Accession Number: 0001737287-20-000059
Submitted to the SEC: Wed Nov 04 2020 8:00:10 AM EST
Accepted by the SEC: Wed Nov 04 2020
Period: Wednesday, September 30, 2020
Industry: Biological Products No Disgnostic Substances

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