Allogene Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
- AlloCAR T™ Studies Resumed and Currently Enrolling Patients Following Removal of Clinical Hold in
- Phase 1 Data from the ALPHA Trials in Relapsed/Refractory (RR) Non-Hodgkin Lymphoma Presented at ASH 2021 Demonstrated Potential for an AlloCAR T Product to be a Safe and Durable Alternative to Autologous Cell Therapy in CAR T Naïve Patients
- Pivotal Phase 2 ALPHA2 Trial of ALLO-501A in R/R Large B Cell Lymphoma on Track to Commence Mid-Year 2022 Pending Ongoing FDA Discussions
- Phase 1 Data Presented at ASH 2021 from the ALLO-715 UNIVERSAL Trial in R/R Multiple Myeloma Demonstrated Potential for an Allogeneic Anti-BCMA CAR T to Achieve Responses Similar to Approved Autologous CAR T Therapy with Added Benefit of Treatment within Five Days of Enrollment and Elimination of Bridging Therapy
- Ended 2021 with $810 Million in Cash, Cash Equivalents and Investments
- Conference Call and Webcast Scheduled for Today at
2:00 PM PT/ 5:00 PM ET
“The FDA hold placed upon our clinical programs presented us with an unexpected challenge during the fourth quarter. In responding to and resolving this challenge, our team continued to demonstrate the qualities of leadership, collaboration, innovation, and focus that are required to be a pioneer in the field of allogeneic T cell therapy. I am incredibly proud of our employees’ commitment and relentless belief in the potential for our products to improve the lives of patients,” said
Allogene has resumed clinical study activities on ALLO-715 and ALLO-605 for relapsed/refractory (R/R) multiple myeloma (MM), and ALLO-316 for advanced or metastatic clear cell renal cell carcinoma (RCC), and began enrolling patients earlier this month. Enrollment in the Phase 1 ALLO-501 ALPHA trial in R/R non-Hodgkin lymphoma (NHL) has completed accrual. The focus remains on preparing for the pivotal Phase 2 ALPHA2 trial of ALLO-501A in R/R Large B Cell Lymphoma (LBCL). Prior to the start of Phase 2, Allogene plans to resume enrollment in the Phase 1 study in order to offer AlloCAR T to patients in need.
Cell Forge 1 (CF1)
CF1, Allogene’s state-of-the-art manufacturing facility located in
Phase 1 data from the ALPHA trial with ALLO-501 and ALPHA2 trial with ALLO-501A for the treatment of R/R NHL was presented at the 2021 Annual
Highlights from the ASH 2021 presentation include:
- AlloCAR T was associated with consistent and 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).
- There were no relapses observed in LBCL CAR T naïve patients across trials who had achieved a complete response (CR) at six months with the longest ongoing CRs with ALLO-501 at 18+ months and ALLO-501A at 15+ months.
- One of the most critical advantages of AlloCAR T was further established with more than 97% of enrolled patients able to receive therapy with the median time from enrollment to initiation of treatment of five days in ALPHA and two days in ALPHA2.
Phase 2 Preparation:
The single-arm ALPHA2 trial is on track to begin mid-year 2022 with FDA discussions directed at finalizing clinical trial design and proactively accelerating activities that address Chemistry Manufacturing and Controls (CMC) requirements.
Allogene is developing ALLO-647, its proprietary anti-CD52 monoclonal antibody intended to enable expansion and persistence of AlloCAR T product candidates, including ALLO-501A. Allogene intends to launch a separate registrational trial for ALLO-647 at the time of the pivotal Phase 2 trial for ALLO-501A as part of the concurrent development plan. This trial is intended to demonstrate the safety of ALLO-647 along with its contribution to the overall benefit of the lymphodepletion regimen.
Anti-BCMA AlloCAR T Program
Allogene’s anti-BCMA strategy includes the Phase 1 UNIVERSAL trial, which has cohorts evaluating ALLO-715 as a monotherapy, consolidated dosing of ALLO-715 using ALLO-647 to selectively extend the window of lymphodepletion, and ALLO-715 in combination with SpringWorks Therapeutics’ investigational gamma secretase inhibitor, nirogacestat. The Phase 1 IGNITE trial is evaluating ALLO-605, Allogene’s first TurboCAR™ candidate. TurboCAR technology allows cytokine activation signaling to be engineered selectively into CAR T cells and has shown the ability to improve the potency and persistence of allogeneic cells in preclinical models. Activity in these trials has resumed and Allogene intends to provide a BCMA program clinical update by the end of 2022.
ALLO-715 UNIVERSAL Trial
Data from the UNIVERSAL trial with ALLO-715 as a monotherapy for the treatment of R/R MM was also presented at ASH 2021. The UNIVERSAL trial is the first allogeneic anti-BCMA CAR T to demonstrate safety and substantial efficacy in MM with response rates that are similar to the approved autologous CAR T therapy.
- The data presented at ASH demonstrated that ALLO-715 was well tolerated with no GvHD and a manageable safety profile.
- There was a 71% Overall Response Rate (ORR) at dose level 3 (320 million AlloCAR T+ cells) with lymphodepletion consisting of fludarabine/cyclophosphamide and ALLO-647
- 46% of patients achieved a Very Good Partial Response or better (VGPR+) including 25% Complete Response or Stringent Complete Response (CR/sCR).
- 92% of patients with VGPR+ were minimal residual disease (MRD) negative.
- Median duration of response (DoR) was 8.3 months at the time of data cut-off.
- Importantly, the study highlighted the ability to initiate treatment within five days of enrollment and eliminate the need for bridging therapy.
Solid Tumor AlloCAR T Program
ALLO-316 (anti-CD70) – TRAVERSE Trial
- The Phase 1 trial for Allogene’s first AlloCAR T candidate for solid tumors, ALLO-316, is designed to evaluate the safety, tolerability, anti-tumor efficacy, pharmacokinetics, and pharmacodynamics of ALLO-316 in patients with advanced or metastatic clear cell RCC. Clinical trial activities have resumed.
Fourth Quarter and Year-End Financial Results
- Research and development expenses were $54.0 million for the fourth quarter of 2021, which includes $11.1 million of non-cash stock-based compensation expense. For the full year of 2021, research and development expenses were
$220.2 million. Research and development expense for the year includes $39.6 millionof non-cash stock-based compensation expense.
- General and administrative expenses were $20.0 million for the fourth quarter of 2021, which includes $10.9 million of non-cash stock-based compensation expense. For the full year of 2021, general and administrative expenses were
$74.1 million, which includes $41.2 millionof non-cash stock-based compensation expense.
- Net loss for the fourth quarter of 2021 was $74.9 million, or $0.54 per share, including non-cash stock-based compensation expense of $22.0 million. For the full year of 2021, net loss was
$257.0 million, or $1.89per share, including non-cash stock-based compensation expense of $80.8 million.
- The Company had
$810 millionin cash, cash equivalents, and investments as of December 31, 2021.
2022 Financial Guidance
- Allogene expects 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 ALPHA, ALPHA2, UNIVERSAL, IGNITE and TRAVERSE trials, including advancing to the Phase 2 portion of the ALPHA2 trial; the timing and ability to initiate a registration 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 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-K for the year ended December 31, 2021. 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.
Statements comparing autologous CAR T data with AlloCAR T data should be viewed with caution, as they involve interpreting results from separate trials involving separate product candidates. There are differences in the clinical trial design, patient populations, published data, follow-up times and the product candidates themselves, and the results from the clinical trials of the autologous CAR T products may have no interpretative value on our existing or future results.
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||$||51||$||—||$||38,489||$||—|
|Research and development||53,983||52,228||220,176||192,987|
|General and administrative||19,961||17,134||74,105||65,256|
|Total operating expenses||73,944||69,362||294,281||258,243|
|Loss from operations||(73,893||)||(69,362||)||(255,792||)||(258,243||)|
|Other income (expense), net:|
|Interest and other income, net||186||1,558||1,714||9,164|
|Total other income (expense), net||(975||)||792||(1,213||)||8,022|
|Net loss per share, basic and diluted||$||(0.54||)||$||(0.53||)||$||(1.89||)||$||(2.08||)|
|Weighted-average number of shares used in computing net loss per share, basic and diluted||139,173,761||129,835,293||135,820,386||120,370,177|
SELECTED BALANCE SHEET DATA
|Cash, cash equivalents and investments||$||809,481||$||1,032,118|
|Total stockholders’ equity||916,406||1,079,617|
Allogene Media/Investor Contact:
Chief Communications Officer
Source: Allogene Therapeutics, Inc.