Allogene Therapeutics Reports Second Quarter 2023 Financial Results and Business Update
- Presented Long-Term Data for an Allogeneic CD19 CAR T Product Candidate in Relapsed/Refractory Large B Cell Lymphoma (LBCL) at the
American Society of Clinical Oncology (ASCO) Annual Meeting and International Conference on Malignant Lymphoma (ICML) Lugano- ALLO-501/501A Demonstrated Rates of Durable Complete Responses Similar to Approved Autologous CAR T Therapies
- Enrollment Ongoing in the ALLO-501A ALPHA2 and EXPAND Phase 2 Trials in LBCL
- ALPHA2 Trial Expected to Complete Enrollment in 1H 2024 with the First Data Readout Planned by Year-End 2024
- Ended Q2 2023 with $545 Million in Cash, Cash Equivalents and Investments
- Includes Approximately
$88 Million in Net Proceeds from At-the-Market (“ATM”) Equity Financing Facility During the Second Quarter; Cash Runway Now Projected to Extend into 2H 2025
- Includes Approximately
- Conference Call and Webcast Scheduled for Today at
2:00 PM PT /5:00 PM ET
“The last few months have been exciting for cell therapy as the transformative potential of an allogeneic CAR T product becomes more evident. Within this framework, we are thrilled that our off-the-shelf CD19 AlloCAR T data continues to demonstrate what I believe to be both first-in-class and best-in class promise in hematological cancers,” said
Pipeline Updates
ALLO-501A: Anti-CD19 AlloCAR T Program
The Company is enrolling patients in the industry’s first potentially pivotal Phase 2 allogeneic CAR T clinical trial with ALLO-501A across sites in
The single-arm ALPHA2 trial in relapsed/refractory (R/R) large B cell lymphoma (LBCL) utilizes a single dose of ALLO-501A (120 million CAR+ cells) following lymphodepletion with FCA90 (fludarabine, 30 mg/m2; cyclophosphamide 300 mg/m2; and ALLO-647 30 mg, daily for 3 days). This trial will enroll approximately 100 patients who have received at least two prior lines of therapy and have not received prior anti-CD19 therapy. The primary endpoint is overall response rate (ORR), and the key secondary endpoint is duration of response (DoR). Patients may receive treatment as an outpatient at the investigator’s discretion. The Company expects to complete enrollment in 1H 2024 with the first data readout by the end of 2024.
Long-term follow up data from the Phase 1 ALPHA/ALPHA2 trials in LBCL was presented at both the
The EXPAND trial is also underway to support licensure of ALLO-647, the Company’s anti-CD52 monoclonal antibody used in conjunction with standard low-dose FC (fludarabine, 30 mg/m2 and cyclophosphamide 300 mg/m2, daily for 3 days) lymphodepletion regimens to control premature rejection of AlloCAR T cells by the patient’s immune system. At the ASCO and Lugano data presentations, the Company’s proprietary lymphodepletion strategy was shown to promote robust AlloCAR T cell expansion and best-in-class longest persistence without incurring significant changes in infectious or immunosuppressive complications as compared to autologous CAR T therapies.
The EXPAND trial, which is designed to demonstrate the contribution of ALLO-647 to the standard low dose FC lymphodepletion, will enroll approximately 70 patients with r/r LBCL who will be randomized to lymphodepletion with FCA90 (which includes 90 mg of ALLO-647) versus FC alone before receiving a single 120 million cell dose of ALLO-501A. The primary endpoint of the study is progression free survival (PFS).
ALLO-316: Anti-CD70 AlloCAR T Program
The ongoing Phase 1 dose escalation TRAVERSE study is enrolling patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed on standard therapies including an immune checkpoint inhibitor and a VEGF-targeting therapy. Initial data from TRAVERSE were presented at the
The Dagger™ effect, which is a feature of ALLO-316, enables ALLO-316 CAR T cells to target and eliminate alloreactive host immune cells, thereby mitigating potential premature rejection of AlloCAR T cells by the patient’s immune system. Translational results shared at AACR suggest this unique immunomodulatory effect of ALLO-316 contributed to robust AlloCAR T cell expansion and persistence, and clinical remissions.
The TRAVERSE trial is now deploying an investigational in vitro companion diagnostic (IVD) assay designed to prospectively assess CD70 expression levels in patients. Dose escalation in the TRAVERSE trial is expected to be completed in 2023.
Based on preclinical results demonstrating the ability to combine anti-CD19 and other AlloCARs™ with the Dagger technology, the Company intends to explore this approach to potentially enhance the activity of next generation AlloCAR T products candidates, including those that target other hematological and solid tumors.
ALLO-715: Anti-BCMA AlloCAR T Program
The Company previously presented ALLO-715 Phase 1 data from the UNIVERSAL trial which was the first study to demonstrate that an allogeneic anti-BCMA CAR T could produce response rates in multiple myeloma similar to an approved autologous CAR T therapy. As treatments in multiple myeloma advance, the Company is evaluating manufacturing process improvement across its BCMA candidates to achieve an improved competitive profile.
Second Quarter Financial Results
- The Company had
$544.5 million in cash, cash equivalents, and investments as ofJune 30, 2023 , which includes net proceeds of approximately$87.9 million raised in the second quarter from an at-the market (ATM) equity financing facility. Based on current expectations, the Company expects its cash runway to fund operations into 2H 2025. - Research and development expenses were
$62.0 million for the second quarter of 2023, which includes$6.9 million of non-cash stock-based compensation expense. - General and administrative expenses were
$18.5 million for the second quarter of 2023, which includes$9.7 million of non-cash stock-based compensation expense. - Net loss for the second quarter of 2023 was
$78.0 million , or$0.53 per share, including non-cash stock-based compensation expense of$16.6 million .
2023 Financial Guidance
- As previously reported, the Company expects a decrease in cash, cash equivalents, and investments of approximately
$230 million in 2023. GAAP Operating Expenses are expected to be approximately$340 million , including estimated non-cash stock-based compensation expense of approximately$80 million . These estimates exclude any impact from potential 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," “projects,” "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: ALPHA2 being a potentially pivotal trial; expected enrollment and related timelines; the expected timing to complete dose escalation; the potential of an allogeneic CAR T product to treat CD70 express RCC based on emerging data; study design; the timing and ability to progress the ALPHA2 and TRAVERSE trials; clinical outcomes, which may materially change as more patient data become available; the ability to achieve optimal clinical performance through manufacturing processes improvements; the design and potential benefits of our Dagger technology, including its ability to resist rejection of AlloCAR T cells by the host immune cells and the expected benefits therefrom, and our plans to deploy Dagger technology; the potential for our product candidates to be approved; the potential benefits of AlloCAR T products and 2023 financial guidance, including expected cash runway. Various factors may cause material differences between Allogene’s expectations and actual results, including, risks and uncertainties related to: our product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; Servier’s discontinuation of its involvement in the development of all CD19 products pursuant to our Exclusive License and Collaboration Agreement and our disputes with
Caution should be exercised regarding statements comparing autologous CAR T data. 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 autologous products may have no interpretative value on our existing or future results.
AlloCAR T™, AlloCAR™ and Dagger™ are trademarks of Allogene Therapeutics, Inc.
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
(unaudited; in thousands, except share and per share data) | |||||
STATEMENTS OF OPERATIONS | |||||
Three Months Ended |
|||||
2023 | 2022 | ||||
Collaboration revenue - related party | $ | 44 | $ | 86 | |
Operating expenses: | |||||
Research and development | $ | 62,038 | $ | 57,171 | |
General and administrative | 18,524 | 19,509 | |||
Total operating expenses | 80,562 | 76,680 | |||
Loss from operations | (80,518) | (76,594) | |||
Other income (expense), net: | |||||
Interest and other income, net | 3,778 | 315 | |||
Other income (expenses) | (1,249) | 1,492 | |||
Total other income, net | 2,529 | 1,807 | |||
Net loss | (77,989) | (74,787) | |||
Net loss per share, basic and diluted | $ | (0.53) | $ | (0.52) | |
Weighted-average number of shares used in computing net loss per share, basic and diluted | 146,795,826 | 143,385,045 | |||
SELECTED BALANCE SHEET DATA | |||||
As of |
As of |
||||
Cash, cash equivalents and investments | $ | 544,548 | $ | 576,471 | |
Total assets | 770,971 | 817,079 | |||
Total liabilities | 148,065 | 151,209 | |||
Total stockholders’ equity | 622,906 | 665,870 | |||
Allogene Media/Investor Contact:
Chief Communications Officer
Christine.Cassiano@allogene.com
Source: Allogene Therapeutics, Inc.