Allogene Therapeutics Reports Second Quarter 2022 Financial Results
U.S.FDA Clearance on Potential Pivotal Phase 2 Trial of ALLO-501A Anticipated in Coming Weeks
- Expected to be the Industry’s First Allogeneic CAR T Phase 2 Pivotal Trial
- Clearance to Cover ALPHA2 Protocol and Chemistry Manufacturing and Controls (CMC) for Use of ALLO-501A Manufactured from Cell Forge 1 (CF1)
- CF1 is Projected to Support the Manufacture of ~20,000 Doses of AlloCAR T™ Products Annually at Scale
- CF1 Earned a LEED® Interior Design and Construction Gold Designation from the
U.S Green Building Council
- Company Plans to Evaluate Potential Phase 2 Pivotal Study Approach and Timing for
BCMA Program for Multiple Myelomaby Year End
- Clinical Updates Focused on Longer-Term Follow-Up in the ALPHA, ALPHA2 and UNIVERSAL Trials Planned for YE 2022
- Ended Second Quarter with
$686 Millionin Cash, Cash Equivalents and Investments
- Quarterly Conference Call and Webcast Scheduled for Today at
2:00 PM PT/ 5:00 PM ET
“We feel confident that we could soon initiate the industry’s first Phase 2 pivotal trial for an allogeneic CAR T product, thereby paving the road not just for ALLO-501A, but our entire portfolio,” said
In the coming weeks, the Company expects to receive clearance from the
In June, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in r/r LBCL. RMAT designation was based on data demonstrating the potential of ALLO-501A to address the unmet need for patients who have failed other therapies. Previously presented data support the potential of ALLO-501A to provide a safe and durable alternative to approved autologous CAR T therapies in CAR T naïve patients, including manageable safety with no dose limiting toxicities (DLTs) or graft-vs-host disease (GvHD) and minimal Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), or Grade 3 cytokine release syndrome (CRS). In the Phase 1 ALPHA2 study, nearly all enrolled patients were able to receive therapy with the median time from enrollment to initiation of treatment of two days.
Allogene anticipates providing an update on the Phase 1 portion of the ALPHA and ALPHA2 trials toward the end of 2022. This update will include a few additional patients enrolled in ALPHA2 and will focus on longer-term follow up of patients previously treated in the ALPHA and ALPHA2 trials.
The EXPAND trial is expected to begin in 2022 and is planned to support registration of the lymphodepleting agent ALLO-647. This trial is intended to demonstrate the contribution of ALLO-647 to the lymphodepletion regimen.
Allogene plans to explore its pivotal study approach and timing for its BCMA program by year end. In parallel, the Company intends to work within the framework afforded by its RMAT designation for ALLO-715 to facilitate FDA interactions and determine the best course forward.
Enrollment continues in the Phase 1 UNIVERSAL trial on ALLO-715 in r/r multiple myeloma (MM). Toward the end of 2022, Allogene intends to provide a clinical update that will focus on the longer-term follow up of patients in UNIVERSAL treated with a single dose of ALLO-715. Allogene has made the decision not to advance ALLO-715 in combination with nirogacestat from SpringWorks Therapeutics into dose expansion cohorts. There was no clear indication that the combination would meaningfully improve the benefit-risk profile of ALLO-715 as a monotherapy. Allogene’s Clinical Trial Collaboration Agreement with SpringWorks is expected to remain in effect until the data from the combination study are fully analyzed.
The IGNITE trial on TurboCAR™ candidate ALLO-605 continues to enroll patients in the dose escalation portion of this Phase 1 study.
Solid Tumor Programs
ALLO-316, which targets CD70, is the Company’s first AlloCAR T candidate for solid tumors. The ongoing 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 FDA previously 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 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.
CF1, Allogene’s commercial scale manufacturing facility located in
In July, Allogene announced the appointment of
Second Quarter Financial Results
- Research and development expenses were
$57.2 millionfor the second quarter of 2022, which includes $13.0 millionof non-cash stock-based compensation expense.
- General and administrative expenses were
$19.5 millionfor the second quarter of 2022, which includes $9.9 millionof non-cash stock-based compensation expense.
- Net loss for the second quarter of 2022 was
$74.8 million, or $0.52per share, including non-cash stock-based compensation expense of $22.9 million.
- The Company had
$686 millionin cash, cash equivalents, and investments as of June 30, 2022.
Updated 2022 Financial Guidance
While the Company anticipates spending to increase in the second half relative to the first half of 2022, it now expects full year GAAP Operating Expenses to be at the low end of the previous range of
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 June 30, 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||$||86||$||44|
|Research and development||$||57,171||$||52,290|
|General and administrative||19,509||18,783|
|Total operating expenses||76,680||71,073|
|Loss from operations||(76,594||)||(71,029||)|
|Other income (expense), net:|
|Interest and other income, net||315||624|
|Total other income (expense), net||1,807||93|
|Net loss per share, basic and diluted||$||(0.52||)||$||(0.53||)|
|Weighted-average number of shares used in computing net loss per share, basic and diluted||143,385,045||134,826,805|
SELECTED BALANCE SHEET DATA
|Cash, cash equivalents and investments||$||686,129||$||809,481|
|Total stockholders’ equity||801,949||916,406|
Allogene Media/Investor Contact:
Chief Communications Officer
Source: Allogene Therapeutics, Inc.