Allogene Therapeutics(ALLO)

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 Allogene Therapeutics(ALLO) - 2019 Q4 - Earnings Call Transcript
 2020-02-27 19:34
Allogene Therapeutics, Inc. (NASDAQ:ALLO) Q4 2019 Earnings Conference Call February 27, 2020 8:30 AM ET Company Participants Christine Cassiano – Chief Communications Officer David Chang – President and Chief Executive Officer Raphael Amado – Executive Vice President of Research and Development and Chief Medical Officer Eric Schmidt – Chief Financial Officer Conference Call Participants Marc Frahm – Cowen and Company Salveen Richter – Goldman Sachs Biren Amin – Jefferies Tyler Van Buren – Piper Sandler Mark ...
 Allogene Therapeutics(ALLO) - 2019 Q3 - Quarterly Report
 2019-11-05 21:02
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ________________________________________________________ FORM 10-Q ________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Numbe ...
 Allogene Therapeutics(ALLO) - 2019 Q3 - Earnings Call Transcript
 2019-11-05 19:57
Allogene Therapeutics, Inc. (NASDAQ:ALLO) Q3 2019 Earnings Conference Call November 5, 2019 8:30 AM ET Company Participants Christine Cassiano - Chief Communications Officer David Chang - President and Chief Executive Officer Rafael Amado - Executive Vice President of Research and Development and Chief Medical Officer Eric Schmidt - Chief Financial Officer Conference Call Participants Biren Amin - Jefferies & Company, Inc. Philip Nadeau - Cowen and Company Tyler Van Buren - Piper Jaffray Amanda Murphy - BTI ...
 Allogene Therapeutics(ALLO) - 2019 Q2 - Quarterly Report
 2019-08-07 20:22
 PART I: FINANCIAL INFORMATION   [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Unaudited condensed financial statements for June 30, 2019, show a $72.8 million net loss, increased accumulated deficit, and $650.2 million liquidity   [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2019, assets decreased to $734.0 million, liabilities increased, and equity decreased to $655.6 million   Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $112,584 | $92,432 | | Total investments | $537,609 | $628,918 | | **Total Assets** | **$733,997** | **$773,855** | | **Liabilities & Equity** | | | | Total current liabilities | $38,000 | $29,459 | | **Total Liabilities** | **$78,362** | **$70,691** | | Accumulated deficit | ($284,357) | ($211,528) | | **Total Stockholders' Equity** | **$655,635** | **$703,164** |   [Condensed Statements of Operations and Comprehensive Loss](index=3&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net losses for the six months ended June 30, 2019, were $72.8 million, significantly lower than 2018 due to a one-time R&D charge   Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $31,774 | $122,486 | $55,177 | $122,486 | | General and administrative | $14,187 | $12,526 | $27,245 | $15,123 | | **Loss from operations** | **($45,961)** | **($135,012)** | **($82,422)** | **($137,609)** | | **Net loss** | **($41,243)** | **($134,902)** | **($72,829)** | **($137,499)** | | Net loss per share | ($0.41) | ($43.82) | ($0.74) | ($9.42) |   [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2019, net cash used in operations was $55.1 million, offset by $77.4 million from investing activities   Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | ($55,148) | ($6,042) | | Net cash provided by (used in) investing activities | $77,380 | ($2,634) | | Net cash provided by financing activities | $920 | $152,603 | | **Net increase in cash, cash equivalents and restricted cash** | **$23,152** | **$143,927** |   [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail the company's immuno-oncology business, accounting policies, financial instruments, and key license and lease disclosures  - The company is a clinical-stage immuno-oncology company focused on allogeneic T cell therapies for cancer, having incurred cumulative net losses of **$284.4 million** since inception and expecting to raise additional capital to fund future operations[20](index=20&type=chunk)[22](index=22&type=chunk) - The company has a license agreement with Cellectis for its TALEN gene-editing technology, with potential milestone payments of up to **$185.0 million** per product and tiered royalties in the high single-digit percentages[43](index=43&type=chunk)[46](index=46&type=chunk) - Under an agreement with Servier for anti-CD19 CAR T cell products (including UCART19), Allogene is responsible for **60%** of specified development costs and has potential milestone payment obligations up to **$381.5 million**[52](index=52&type=chunk)[56](index=56&type=chunk)[57](index=57&type=chunk) - In February 2019, the company entered into a lease for a **118,000 sq. ft.** manufacturing facility in Newark, CA, with total undiscounted lease payment commitments of **$36.2 million**[67](index=67&type=chunk)   [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the immuno-oncology pipeline, decreased R&D expenses from a prior year charge, and $650.2 million in liquidity  - The company is advancing its pipeline, with the FDA clearing an IND for ALLO-715 in multiple myeloma in May 2019 and plans to initiate the UNIVERSAL trial in 2019[92](index=92&type=chunk) - As of June 30, 2019, the company had **$650.2 million** in cash, cash equivalents, and investments, which management believes is sufficient to fund operations for at least one year[94](index=94&type=chunk)[123](index=123&type=chunk)   [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Total operating expenses decreased by $55.2 million for the six months ended June 30, 2019, driven by a $67.3 million R&D reduction   Comparison of Operating Results (in thousands) | Metric | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $55,177 | $122,486 | ($67,309) | (55)% | | General and administrative | $27,245 | $15,123 | $12,122 | 80% | | **Total operating expenses** | **$82,422** | **$137,609** | **($55,187)** | **(40)%** | | **Net Loss** | **($72,829)** | **($137,499)** | **$64,670** | **(47)%** |  - The decrease in R&D expenses for the six months ended June 30, 2019, was primarily due to a **$109.4 million** expense in 2018 for acquired in-process R&D assets from Pfizer, partially offset by a **$42.0 million** increase in other R&D costs[119](index=119&type=chunk)   [Liquidity, Capital Resources and Plan of Operations](index=25&type=section&id=Liquidity%2C%20Capital%20Resources%20and%20Plan%20of%20Operations) As of June 30, 2019, the company held $650.2 million in cash and investments, used $55.1 million in operations, and needs more financing   Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2019 | 2018 | | :--- | :--- | :--- | | Operating activities | ($55,148) | ($6,042) | | Investing activities | $77,380 | ($2,634) | | Financing activities | $920 | $152,603 |  - In February 2019, the company entered into a lease for a cell therapy manufacturing facility in Newark, California, with a term of **15 years and 8 months**, expected to commence in May 2020[134](index=134&type=chunk)   [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risks are interest rate fluctuations on the $650.2 million investment portfolio and foreign exchange rate risk  - The company is exposed to interest rate risk on its cash and investment portfolio of **$650.2 million** as of June 30, 2019[144](index=144&type=chunk) - Foreign exchange risk exists due to collaboration payments with Servier, with **$5.3 million** of liabilities denominated in foreign currencies as of June 30, 2019[145](index=145&type=chunk)   [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2019, with no material changes to internal control over financial reporting  - The CEO and CFO concluded that as of the end of the quarter, the company's disclosure controls and procedures were effective[146](index=146&type=chunk) - No material changes to the company's internal control over financial reporting were identified during the quarter ended June 30, 2019[147](index=147&type=chunk)   PART II: OTHER INFORMATION   [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no current legal proceedings that would materially adversely affect its financial condition or operations  - Management believes there are currently no pending claims or actions against the company that could have a material adverse effect on its business[149](index=149&type=chunk)   [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) Extensive risks include limited operating history, reliance on novel technologies and partners, clinical development, manufacturing, and funding needs  - The company's allogeneic T cell product candidates represent a novel approach with significant challenges, including manufacturing, managing potential side effects like GvHD, and navigating an uncertain regulatory landscape[155](index=155&type=chunk) - The business is heavily reliant on partners for key technologies (Cellectis's TALEN gene-editing) and for the clinical development of lead candidates UCART19 and ALLO-501 (Servier)[158](index=158&type=chunk)[160](index=160&type=chunk) - The company faces substantial financial risk, having incurred significant net losses since inception (**$284.4 million** accumulated deficit) and anticipating the need for substantial additional financing to complete development and commercialization[153](index=153&type=chunk)[231](index=231&type=chunk) - The company intends to operate its own manufacturing facility but faces risks in completing the build-out, scaling production, and gaining regulatory approval, which could impact clinical trials and commercial viability[201](index=201&type=chunk)[202](index=202&type=chunk)   [Unregistered Sales of Equity Securities and Use of Proceeds](index=67&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company details the use of $343.0 million net IPO proceeds from October 2018, unused and held in cash and investments as of June 30, 2019  - The company completed its IPO in October 2018, raising approximately **$343.0 million** in net proceeds[379](index=379&type=chunk)[380](index=380&type=chunk) - Through June 30, 2019, the company has not used any of the net proceeds from its IPO, which are being held in cash, cash equivalents, and investments[381](index=381&type=chunk)   [Other Items (3, 4, 5, 6)](index=67&type=section&id=Other%20Items) The company reports no defaults on senior securities, no mine safety disclosures, and no other information, with Item 6 listing exhibits  - The company reports no defaults upon senior securities, no mine safety disclosures, and no other information for the period[382](index=382&type=chunk)[383](index=383&type=chunk)
 Allogene Therapeutics(ALLO) - 2019 Q1 - Quarterly Report
 2019-05-07 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |----------------------------------------------------------------------------------------------------------------------|----------------------------------------------| | | | | F ...
 Allogene Therapeutics(ALLO) - 2018 Q4 - Annual Report
 2019-03-08 21:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10‑K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001‑38693 Allogene Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 82-3562771 (State or other jurisdic ...
