Allogene Therapeutics Reports Second Quarter 2021 Financial Results
CD19 Program Highlights
- Phase 1 ALPHA Data at ASCO 2021 Showed a Single Dose of ALLO-501 was Associated with Overall Response, Complete Response and Durable Response Rates on Par with Autologous CD19 CAR T Therapies in CAR T Naïve Patients with Relapsed/Refractory Non-Hodgkin Lymphoma
- Next CD19 Program Clinical Update Planned for Q4 2021
- ALLO-501A Pivotal Trial on Track for Initiation in Late 2021
BCMA Program Highlights
- Updated Phase 1 UNIVERSAL Data on ALLO-715 Planned for Q4 2021
- Began Dosing Patients in Phase 1 IGNITE Trial of ALLO-605, the First TurboCAR™ T Cell Therapy, for Relapsed/Refractory Multiple Myeloma
- ALLO-605 Granted Fast Track Designation by the FDA
Solid Tumor Program Highlights
- Phase 1 TRAVERSE Trial Ongoing for ALLO-316 (anti-CD70) in Advanced or Metastatic Renal Cell Carcinoma. Initial Clinical Readout Expected in 2022
Corporate Highlights
- Appointed
Liz Barrett andVicki Sato , Ph.D., Executives with Significant Strategic and Commercial Expertise, to the Board of Directors - State-of-the-Art cGMP Manufacturing Facility in
Newark, California to Support Industry’s First Allogeneic Pivotal Trial and Future Commercial Launch - Ended Second Quarter with $913 Million in Cash, Cash Equivalents and Investments
- Quarterly Conference Call and Webcast Scheduled for 2:00 PM PT/
5:00 PM ET
“We have made exceptional progress across our broad pipeline of AlloCAR T candidates, bringing our goal of revolutionizing cell therapy for patients with blood cancers and solid tumors closer to reality,” said
Pipeline Highlights
Anti-CD19 Program: ALPHA and ALPHA2 Trials
- Updated data from the ongoing Phase 1 ALPHA (ALLO-501) and ALPHA2 (ALLO-501A) trials in relapsed/refractory non-Hodgkin lymphoma (NHL) presented at the Company’s
CD19 Forum in May and Annual Meeting of theAmerican Society of Clinical Oncology (ASCO) in June. - Data from the ALPHA trial supports the ability of a single administration of ALLO-501 to generate deep and durable responses at a rate that is similar to approved autologous CAR T therapies. In the trial, 98% of patients received ALLO-501 with an average time from enrollment to the start of therapy of five days.
- Durable complete responses (CR) were observed with the longest ongoing CR at 15 months in both large B cell lymphoma (LBCL) and follicular lymphoma.
- Overall response rate (ORR) of 75% and CR rate of 50% across histologies in CAR T naïve patients, and on par with data from pivotal trials of autologous CAR T therapies.
- Six-month CR rate of 36% in CAR T naïve patients with LBCL.
- Interim Phase 1 ALPHA2 data demonstrated a comparable efficacy and safety profile for ALLO-501A relative to ALLO-501.
- Consolidation dosing was well tolerated and showed early promise with four patients converting from partial response (PR) to CR following second dose of ALLO-501 or ALLO-501A.
- 75% ORR and 63% CR among patients (n=8) treated in the consolidation cohorts across ALPHA studies.
- ALLO-501 and ALLO-501A demonstrated a manageable safety profile with no dose limiting toxicities or graft-vs-host disease, limited immune effector cell-associated neurotoxicity syndrome (ICANS) and cytokine release syndrome (CRS) observed.
- Next readout from this program is expected in late 2021.
- The Company plans to collect additional data from the consolidation arms of the ALPHA and ALPHA2 studies, finalize a dose and schedule of ALLO-501A and lymphodepletion for a pivotal Phase 2 trial, and discuss the Phase 2 trial design with regulatory authorities.
- Pending regulatory feedback, the Company plans to move to the Phase 2 Pivotal ALPHA2 trial at the end of 2021.
Anti-BCMA AlloCAR T Program
The Company continues to advance its portfolio of allogeneic therapies targeting the B cell maturation antigen (BCMA) for patients with multiple myeloma (MM).
- ALLO-715 UNIVERSAL Trial
- The UNIVERSAL trial, investigating ALLO-715 as a monotherapy and in combination with nirogacestat, SpringWorks Therapeutics’ investigational gamma secretase inhibitor, continues to enroll patients with relapsed/refractory MM.
- Updated data from the monotherapy arm of the study are anticipated in Q4 2021.
- In April, ALLO-715 was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the
U.S. Food and Drug Administration (FDA).
- ALLO-605 TurboCAR™ IGNITE Trial
- The Phase 1 dose escalation portion of the IGNITE trial evaluating ALLO-605, the first anti-BCMA TurboCAR T cell therapy, began dosing patients.
- In June, the FDA granted ALLO-605 Fast Track designation based on the potential of ALLO-605 to address the unmet need for patients who have failed other standard MM therapies.
Solid Tumor AlloCAR T Program
- ALLO-316 (anti-CD70) TRAVERSE Trial
The Phase 1 TRAVERSE trial of ALLO-316, Allogene’s first CAR T candidate for solid tumors, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) continues to progress with initial data anticipated in 2022. The trial is examining safety, tolerability, anti-tumor efficacy, pharmacokinetics and pharmacodynamics of ALLO-316.
Corporate Highlights
- Manufacturing Updates
- The Company plans to unveil its state-of-the-art cGMP cell manufacturing facility, Cell Forge 1, in
Newark, California in preparation for a pivotal trial of ALLO-501A and future commercialization. Company is on track to begin cGMP production in this facility in the second half of 2021.
- The Company plans to unveil its state-of-the-art cGMP cell manufacturing facility, Cell Forge 1, in
- Allogene Overland Biopharm
- Allogene Overland Biopharm, a joint venture created with
Overland Pharmaceuticals , appointed Shuyuan Yao, Ph.D., as Chief Executive Officer. Dr. Yao brings 15 years of scientific and management experience in advanced cell and gene therapy development, manufacturing and commercialization, and will lead Allogene Overland in its mission to bring certain AlloCAR T therapies to patients in China and other Asian Pacific markets.
- Allogene Overland Biopharm, a joint venture created with
Second Quarter Financial Results
- Research and development expenses were $52.3 million for the second quarter of 2021, which includes $10.5 million of non-cash stock-based compensation expense.
- General and administrative expenses were $18.8 million for the second quarter of 2021, which includes $10.6 million of non-cash stock-based compensation expense.
- Net loss for the second quarter of 2021 was $70.9 million, or $0.53 per share, including non-cash stock-based compensation expense of $21.1 million.
- The Company had
$913.2 million in cash, cash equivalents, and investments as ofJune 30, 2021 .
Allogene continues to expect full year GAAP Operating Expenses to be between $300 million and $330 million including estimated non-cash stock-based compensation expense of $80 million to $90 million and excluding any impact from potential new business development activities.
Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at
About
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 progressing to the Phase 2 portion of the ALPHA2 trial, and present any data from the trials; clinical outcomes, which may materially change as patient enrollment continues and more patient data become available; the ability to manufacture AlloCAR T™ therapies, including for use in clinical trials and at the Company’s manufacturing facility; the potential benefits of AlloCAR T™ therapy; and the 2021 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
Comparative statements regarding autologous CAR T data are based on review of Kymriah United States product insert (USPI), Schuster S et
AlloCAR T™ and TurboCAR™ are trademarks of
Allogene’s CD19 AlloCAR T program utilizes Cellectis technologies. ALLO-501 and ALLO-501A are being jointly developed under a collaboration agreement between
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SELECTED FINANCIAL DATA
(unaudited; in thousands, except share and per share data)
STATEMENTS OF OPERATIONS
Three Months Ended |
Six Months Ended |
||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||
Collaboration revenue - related party | $ | 44 | $ | — | $ | 38,389 | $ | — | |||||||||||
Operating expenses: | |||||||||||||||||||
Research and development | $ | 52,290 | $ | 47,296 | $ | 107,473 | $ | 89,337 | |||||||||||
General and administrative | 18,783 | 15,862 | 35,146 | 31,502 | |||||||||||||||
Total operating expenses | 71,073 | 63,158 | 142,619 | 120,839 | |||||||||||||||
Loss from operations | (71,029 | ) | (63,158 | ) | (104,230 | ) | (120,839 | ) | |||||||||||
Other income (expense), net: | |||||||||||||||||||
Interest and other income, net | 624 | 2,340 | 1,135 | 5,600 | |||||||||||||||
Other expenses | (531 | ) | (156 | ) | (856 | ) | (215 | ) | |||||||||||
Total other income (expense), net | 93 | 2,184 | 279 | 5,385 | |||||||||||||||
Net loss | (70,936 | ) | (60,974 | ) | (103,951 | ) | (115,454 | ) | |||||||||||
Net loss per share, basic and diluted | $ | (0.53 | ) | $ | (0.53 | ) | $ | (0.78 | ) | $ | (1.03 | ) | |||||||
Weighted-average number of shares used in computing net loss per share, basic and diluted | 134,826,805 | 115,377,210 | 133,503,262 | 112,163,123 |
SELECTED BALANCE SHEET DATA
As of |
As of |
||||||
Cash, cash equivalents and investments | $ | 913,230 | $ | 1,032,118 | |||
Total assets | 1,126,724 | 1,227,829 | |||||
Total liabilities | 102,912 | 148,212 | |||||
Total stockholders’ equity | 1,023,812 | 1,079,617 |
Allogene Media/Investor Contact:
Chief Communications Officer
(714) 552-0326
Christine.Cassiano@allogene.com
Source: Allogene Therapeutics, Inc.