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

Allogene Therapeutics, Inc.

CIK: 1737287 Ticker: ALLO

Exhibit 99.1
g725933allogenea061.jpg

Allogene Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results

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 TTM, 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 TurboCARTM 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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Inside this 10-K Annual Report

Cover Page
Balance Sheets
Balance Sheets (Parenthetical)
Condensed Statements Of Operations And Comprehensive Loss
Statements Of Cash Flows
Statements Of Convertible Preferred Stock And Stockholders' Equity (Deficit)
Statements Of Convertible Preferred Stock And Stockholders' Equity (Deficit) (Parenthetical)
401(K) Plan
401(K) Plan (Details)
Asset Acquisition
Asset Acquisition (Tables)
Asset Acquisition - Additional Information (Details)
Asset Acquisition - Schedule Of Fair Value Of Assets Acquired (Details)
Balance Sheet Components
Balance Sheet Components (Tables)
Balance Sheet Components - Additional Information (Details)
Balance Sheet Components - Schedule Of Accrued Liabilities (Details)
Balance Sheet Components - Schedule Of Intangible Assets (Details)
Balance Sheet Components - Schedule Of Prepaid Expenses And Other Current Assets (Details)
Balance Sheet Components - Schedule Of Property And Equipment, Net (Details)
Commitments And Contingencies
Convertible Notes Payable (2018 Notes)
Convertible Notes Payable (2018 Notes) (Details)
Convertible Preferred Stock And Stockholders' Deficit (Details)
Convertible Preferred Stock And Stockholders' Equity
Description Of Business And Summary Of Significant Accounting Policies
Description Of Business And Summary Of Significant Accounting Policies (Policies)
Description Of Business And Summary Of Significant Accounting Policies (Tables)
Description Of Business And Summary Of Significant Accounting Policies - Additional Information (Details)
Description Of Business And Summary Of Significant Accounting Policies - Schedule Of Estimated Life Of Assets (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 Measured At Fair Value On Recurring Basis (Detail)
Income Taxes
Income Taxes (Tables)
Income Taxes - Additional Information (Details)
Income Taxes - Schedule Of Deferred Tax Assets And Liabilities (Details)
Income Taxes - Schedule Of Income Tax Reconciliation (Details)
Income Taxes - Schedule Of Reconciliation Of Unrecognized Tax Benefits (Details)
Income Taxes - Summary Of Operating Loss Carryforwards And Tax Credits (Details)
Income Taxes - Summary Of Valuation Allowance (Details)
Investment (Tables)
Investment - Additional Information (Details)
Investments
Investments - Schedule Of Fair Values Of Available For Sale Debt Investments By Contractual Maturity (Detail)
Investments - Summary Of Cash Equivalents, Restricted Cash And Investments, Classified As Available-For-Sale Securities (Details)
Leases
Leases (Tables)
Leases - Additional Information (Details)
Leases - Summary Of Undiscounted Future Non-Cancellable Lease Payments Under Operating Leases (Details)
License And Collaboration Agreements
License And Collaboration Agreements (Details)
Net Loss And Net Loss Per Share
Net Loss And Net Loss Per Share (Tables)
Net Loss And Net Loss Per Share - Schedule Of Anti-Dilutive Shares (Details)
Net Loss And Net Loss Per Share - Schedule Of Earnings Per Share Basic And Diluted (Details)
Recent Accounting Guidance
Related Party Transactions
Related Party Transactions (Details)
Selected Quarterly Financial Data (Unaudited)
Selected Quarterly Financial Data (Unaudited) (Details)
Selected Quarterly Financial Data (Unaudited) (Tables)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Details)
Stock-Based Compensation - Schedule Of Share-Based Payment Award, Employee Stock Purchase Plan, Valuation Assumptions (Details)
Stock-Based Compensation - Schedule Of Share-Based Payment Award, Stock Options, Valuation Assumptions (Details)
Stock-Based Compensation - Schedule Of Stock-Based Compensation Expense (Details)
Stock-Based Compensation - Summary Of Restricted Stock Activity (Details)
Stock-Based Compensation - Summary Of Stock Option Activity Under Plan (Details)
Subsequent Events
Subsequent Events (Details)
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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