Allogene Therapeutics Reports First Quarter 2022 Financial Results
- Pivotal Phase 2 ALPHA2 Trial of ALLO-501A in R/R Large B Cell Lymphoma Planned to Commence Mid 2022 Using Product from Cell Forge 1 (CF1)
- CF1 is Projected to Support the Manufacture of ~20,000 Doses of AlloCAR T™ Products Annually at Scale
- Clinical Updates from the CD19 and BCMA Programs Planned for 2H 2022
- Received FDA Orphan Drug Designation (ODD) for ALLO-605, the First TurboCAR™ Product Candidate for the Treatment of Multiple Myeloma
- Phase 1 TRAVERSE Trial of ALLO-316 Targeting CD70 for the Treatment of Renal Cell Carcinoma Continues to Enroll Patients
- FDA Granted Fast Track Designation for ALLO-316 for the Treatment of Renal Cell Carcinoma
- Preclinical Data on ALLO-316 Presented at AACR’s Annual Meeting
- Ended First Quarter with
$733 Millionin Cash, Cash Equivalents and Investments
- Quarterly Conference Call and Webcast Scheduled for Today at
2:00 PM PT/ 5:00 PM ET
“This month marks the fourth anniversary of Allogene. I am immensely proud of all that we have accomplished in such a short period of time, including our ability to treat more patients with our pipeline of AlloCAR T candidates than anyone else in the field,” said
Cell Forge 1 (CF1), Allogene’s commercial scale manufacturing facility located in
In March, the Company published its inaugural ESG report. The report details Allogene’s commitment to corporate integrity and sustainable business operations and highlights its priorities: employees, the environment, and patients, including increasing their access to potential life-saving products.
Enrollment in the Phase 1 ALLO-501A ALPHA2 trial in relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) has re-opened with the goal of offering AlloCAR T to patients while the Company prepares to launch the pivotal Phase 2 ALPHA2 trial. The single-arm pivotal ALPHA2 trial of ALLO-501A in r/r LBCL is on track to begin mid-year 2022 with FDA discussions directed at finalizing clinical trial design and Chemistry Manufacturing and Controls (CMC) requirements.
The EXPAND trial, planned to support registration of the lymphodepleting agent ALLO-647, is intended to demonstrate the contribution of ALLO-647 to the lymphodepletion regimen.
Enrollment has also resumed in trials targeting BCMA for the treatment of patients with r/r multiple myeloma (MM), including the UNIVERSAL trial with ALLO-715 and the IGNITE trial with TurboCAR™ candidate, ALLO-605. In April, preclinical data was published demonstrating the superior long-term in vitro myeloma-killing activity of allogeneic anti-BCMA CAR T cells from healthy donors compared with anti-BCMA CAR T cells from patients with MM. The findings were published in
ALLO-316 is the Company’s first AlloCAR T candidate for solid tumors. The Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, anti-tumor efficacy, pharmacokinetics, and pharmacodynamics of ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma (RCC). The trial, now in its second dose level cohort, continues to accrue patients.
In April, the Company presented preclinical data at the 2022 AACR Annual Meeting which support the ongoing clinical evaluation of ALLO-316 for the treatment of patients with RCC and other CD70 expressing cancers. The findings were simultaneously published in AACR’s
In March, the FDA granted ALLO-316 Fast Track Designation (FTD) based on its potential to address the unmet need for patients with difficult to treat RCC who have failed standard RCC therapies. Metastatic solid tumors have historically been a challenge regardless of treatment modality, and the five-year survival rate for patients with advanced kidney cancer is less than 15%, highlighting the need for innovation.
First Quarter Financial Results
- Research and development expenses were
$60.2 millionfor the first quarter of 2022, which includes $11.1 millionof non-cash stock-based compensation expense.
- General and administrative expenses were
$19.9 millionfor the first quarter of 2022, which includes $11.2 millionof non-cash stock-based compensation expense.
- Net loss for the first quarter of 2022 was
$79.9 million, or $0.56per share, including non-cash stock-based compensation expense of $22.3 million.
- The Company had
$733.1 millionin cash, cash equivalents, and investments as of March 31, 2022.
2022 Financial Guidance
- Allogene continues to expect full year GAAP Operating Expenses to be between
$360 millionand $390 millionincluding estimated non-cash stock-based compensation expense of $90 millionto $100 millionand excluding any impact from potential business development activities.
Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability to progress the ALPHA2, UNIVERSAL, IGNITE and TRAVERSE trials, including advancing to the Phase 2 portion of the ALPHA2 trial; the timing and ability to initiate the EXPAND trial for ALLO-647; clinical outcomes, which may materially change as more patient data become available; the ability to manufacture AlloCAR T™ products, including obtaining FDA agreement to use ALLO-501A manufactured at the Company’s manufacturing facility for use in the ALPHA2 trial; the projection related to the number of AlloCAR T doses that can be produced at Cell Forge 1 at scale on an annual basis; the potential benefits of AlloCAR T products; and 2022 financial guidance. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the SEC, including without limitation in its Form 10-Q for the quarter ended March 31, 2022. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
AlloCAR T™ and TurboCAR™ are trademarks of Allogene Therapeutics, Inc.
TALEN® is a registered trademark of
Allogene’s AlloCAR T™ programs utilize Cellectis technologies. ALLO-501 and ALLO-501A are anti-CD19 products being jointly developed under a collaboration agreement between
SELECTED FINANCIAL DATA
(unaudited; in thousands, except share and per share data)
STATEMENTS OF OPERATIONS
|Three Months Ended
|Collaboration revenue - related party||$||61||$||38,345|
|Research and development||$||60,156||$||55,183|
|General and administrative||19,897||16,363|
|Total operating expenses||80,053||71,546|
|Loss from operations||(79,992||)||(33,201||)|
|Other income (expense), net:|
|Interest and other income, net||492||511|
|Total other income (expense), net||142||186|
|Net loss per share, basic and diluted||$||(0.56||)||$||(0.25||)|
|Weighted-average number of shares used in computing net loss per share, basic and diluted||141,356,306||132,165,014|
SELECTED BALANCE SHEET DATA
|Cash, cash equivalents and investments||$||733,143||$||809,481|
|Total stockholders’ equity||855,230||916,406|
Allogene Media/Investor Contact:
Chief Communications Officer
Source: Allogene Therapeutics, Inc.