Allogene Therapeutics Reports First Quarter 2020 Financial Results
- Oral Presentation of Initial Results from the Phase 1 ALLO-501 ALPHA Trial in Relapsed/Refractory Non-Hodgkin Lymphoma at the
Virtual American Society of Clinical Oncology(ASCO) Annual Meeting
- Phase 1 ALPHA2 Trial for ALLO-501A, the Next Generation anti-CD19 AlloCAR T™ Intended for Phase 2 Development, On-Track to Initiate in Q2 2020
- Initial Data from Phase 1 ALLO-715 UNIVERSAL Trial in Relapsed/Refractory Multiple Myeloma On-Track for Q4 2020
- Pre-clinical Findings Supporting TurboCAR™ Technology to be Presented at the
American Society of Gene & Cell Therapy(ASGCT) 2020 Annual Meeting
- Ended First Quarter with
$553 Millionin Cash, Cash Equivalents and Investments
- Conference Call and Webcast Scheduled for
5:30 AM PT/ 8:30 AM ET
“While the COVID-19 pandemic has create a challenging situation across the world, we are grateful to the employees of Allogene, the investigators and patients participating in our trials, and our countless partners and suppliers who have helped us to progress development of our AlloCAR T therapies,” said
ALLO-501/ALLO-501A (anti-CD19 AlloCAR T)
- Initial data from the Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) was selected for an oral presentation at the virtual
American Society of Clinical Oncology(ASCO) meeting on May 29, 2020. The ALPHA trial utilizes ALLO-647, the Company’s anti-CD52 monoclonal antibody (mAb) as a part of the lymphodepletion regimen. The Phase 1 trial is designed to assess the safety of ALLO-501 and ALLO-647 and establish appropriate doses for further study.
- The ASCO abstract will be released
May 13, 2020and will include preliminary data from the first nine patients treated in this study. The virtual presentation will include additional patients, including patients treated with a higher dose of ALLO-647.
- The ASCO abstract will be released
- The Company expects to initiate enrollment in ALPHA2, an abbreviated Phase 1 trial for ALLO-501A, in Q2 2020. ALLO-501A is a next generation anti-CD19 AlloCAR T that is intended for Phase 2 development.
ALLO-715 (anti-BCMA AlloCAR T)
- The Company continues to progress its robust anti-BCMA strategy centered around ALLO-715 for the treatment of multiple myeloma (MM).
- The ALLO-715 Phase 1 UNIVERSAL trial in patients with relapsed/refractory MM, which utilizes ALLO-647 as part of the lymphodepletion platform, is enrolling patients with initial data anticipated in Q4 2020.
- A trial to evaluate ALLO-715 in combination with SpringWorks’ investigational gamma secretase inhibitor, nirogacestat, in patients with relapsed/refractory MM is on track to begin in the second half of 2020.
- Pre-clinical data on the Company’s internally developed TurboCAR™ technology will be presented in a poster session at the virtual
American Society of Gene & Cell Therapy(ASGCT) 23rd Annual Meeting on May 12, 2020. TurboCAR technology allows cytokine activation signaling to be engineered selectively into CAR T cells. TurboCAR has the potential to improve efficacy, overcome the potential for exhaustion, and reduce cell dose requirements of AlloCAR T therapy.
- The Company plans to submit an Investigational New Drug (IND) application for its first TurboCAR candidate, ALLO-605, a BCMA-directed AlloCAR T therapy for MM, in 2021.
Other Portfolio Updates
- The Company has continued to progress pre-clinical work on ALLO-316, its anti-CD70 AlloCAR T clinical candidate. ALLO-316 has potential application in both hematologic malignancies and solid tumors. The initial focus for this investigational therapy will be renal cell carcinoma. The Company plans to submit an IND by the end of 2020.
- Construction of the Company’s cGMP cell manufacturing facility in
Newark, California, has resumed following interruption due to the COVID-19 pandemic. The Company continues to expect to initiate cGMP manufacturing in 2021.
First Quarter Financial Results
- As of
March 31, 2020, Allogene had $553.0 millionin cash, cash equivalents, and investments.
- Research and development expenses were
$42.0 millionfor the first quarter of 2020, which includes $6.6 millionof non-cash stock-based compensation expense.
- General and administrative expenses were
$15.6 millionfor the first quarter of 2020, which includes $7.6 millionof non-cash stock-based compensation expense.
- Net loss for the first quarter of 2020 was
$54.5 million, or $0.50per share, including non-cash stock-based compensation expense of $14.2 million.
2020 Financial Guidance
- Allogene continues to expect full year GAAP net losses to be between
$260 millionand $280 millionincluding estimated non-cash stock-based compensation expense of $70 millionto $75 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 clinical trials of ALLO-501 and ALLO-715 and present any data from the trials, the timing and ability to initiate and progress a clinical trial of ALLO-501A, the timing and ability to initiate a clinical trial of ALLO-715 in combination with SpringWorks’ nirogacestat, the timing and ability to file an IND and initiate clinical trials of ALLO-316 and ALLO-605, the ability to manufacture AlloCAR T™ therapies, including ALLO-501A, ALLO-316 and ALLO-605 for use in clinical trials, the potential benefits of AlloCAR T™ therapy and the 2020 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
AlloCAR™ and TurboCAR™ are trademarks of
Allogene’s AlloCAR T programs utilize Cellectis technologies. ALLO-501 is an anti-CD19 allogeneic CAR T (AlloCAR T™) therapy being jointly developed under a collaboration agreement between
The anti-BCMA and anti-CD70 AlloCAR T programs are licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to these AlloCAR T programs.
SELECTED FINANCIAL DATA
(unaudited; in thousands, except share and per share data)
STATEMENTS OF OPERATIONS
|Three Months Ended
|Research and development||$||42,042||$||23,403|
|General and administrative||15,641||13,058|
|Total operating expenses||57,683||36,461|
|Loss from operations||(57,683||)||(36,461||)|
|Other income (expense), net:|
|Interest and other income, net||3,261||4,825|
|Total other income (expense), net||3,203||4,825|
|Loss before income taxes||(54,480||)||(31,636||)|
|Benefit from income taxes||—||50|
|Net loss per share, basic and diluted||$||(0.50||)||$||(0.32||)|
|Weighted-average number of shares used in computing net loss per share, basic and diluted||108,963,522||97,315,890|
SELECTED BALANCE SHEET DATA
|Cash, cash equivalents and investments||$||553,044||$||588,855|
|Total stockholders’ equity||606,519||629,023|
Allogene Media/Investor Contact:
Chief Communications Officer
Source: Allogene Therapeutics, Inc.