Allogene Therapeutics Reports Second Quarter 2020 Financial Results
- Initial Phase 1 Results from the ALLO-501 ALPHA Trial at ASCO Demonstrated an Overall Response Rate of 75% and Complete Response Rate of 44% in CAR T Naïve Relapsed/Refractory Non-Hodgkin Lymphoma Patients
- In the ALPHA Trial, Higher Dose ALLO-647 was Associated with Deeper Lymphodepletion, Delayed Host T Cell Recovery and a Higher Complete Response Rate
- Initiated Phase 1 Portion of ALPHA2 Trial for ALLO-501A, a Next-Generation anti-CD19 AlloCAR T™ Intended for Phase 2 Development
- Completed Initial Dose Escalation Portion of the Phase 1 ALLO-715 UNIVERSAL Trial in Relapsed/Refractory Multiple Myeloma with Data Expected in Q4 2020
- Investigational New Drug (IND) Application to Evaluate ALLO-316, an anti-CD70 AlloCAR T in Renal Cell Carcinoma Expected by Year End
- cGMP Production in Newark Manufacturing Facility On Track for 2021
- Ended Second Quarter with
$1.1 Billionin Cash, Cash Equivalents and Investments
- Conference Call and Webcast Scheduled for
5:30 AM PT/ 8:30 AM ET
"We are incredibly pleased with the progress we’ve made across our AlloCAR T platform, which now includes ongoing clinical trials for ALLO-501, ALLO-501A and ALLO-715," said
Anti-CD19 AlloCAR T Program
Initial data from ALLO-501’s ALPHA trial provided support for the Company’s approach to AlloCAR T therapy. Allogene intends to leverage ALLO-501 to optimize trial design and dose selection as it prepares for a potentially pivotal Phase 2 trial of ALLO-501A in 2021.
- ALLO-501 ALPHA Phase 1 Trial
May 2020at the American Society of Clinical Oncology(ASCO) annual meeting, the Company presented initial data from its dose escalation Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL). This study utilizes ALLO-647, the Company’s anti-CD52 monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen. The next readout from this trial is expected to be in late 2020 or early 2021.
As per the ASCO presentation, 22 patients were evaluable for safety and 19 patients were evaluable for efficacy with at least one tumor assessment as of the
- Responses were observed across all cell doses and NHL histologies (diffuse large B-cell lymphoma and follicular lymphoma).
- Across all evaluable patients, there were seven complete responses (CR) and five partial responses (PR) for an overall response rate (ORR) of 63% and CR rate of 37%.
- In CAR T naïve patients (n=16) the ORR was 75% and the CR rate 44%.
- Higher dose ALLO-647 was associated with a higher CR rate.
- With a median follow-up of 3.8 months, nine of the 12 responding patients (75%) remained in response as of the data cutoff on
May 11, 2020.
- No dose limiting toxicities, graft-vs-host disease, or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) was observed. Cytokine release syndrome occurred in 32% of the patients, was mainly mild to moderate in severity and manageable with standard recommendations. Four patients (18%) experienced serious adverse events (SAE), all of which resolved.
- ALLO-501A ALPHA2 Phase 1 Trial
ALLO-501A is a next generation anti-CD19 AlloCAR T intended for Phase 2 development. During the second quarter, the Company initiated enrollment in the Phase 1 portion of the ALPHA2 trial. This abbreviated dose escalation study is a single-arm, open-label, multicenter trial of ALLO-501A in patients with R/R large B-cell lymphoma. The Company expects to begin the Phase 2 portion of this study in 2021.
Anti-BCMA AlloCAR T Program
The Company continues to progress its robust anti-BCMA strategy centered around ALLO-715 for the treatment of multiple myeloma (MM).
- ALLO-715 UNIVERSAL Phase 1 Trial
- The ALLO-715 Phase 1 UNIVERSAL trial in patients with relapsed/refractory MM utilizes ALLO-647 as part of the lymphodepletion platform. The initial dose escalation portion of the UNIVERSAL trial using 39mg of ALLO-647 is now complete. The trial continues to enroll patients with initial data anticipated in Q4 2020.
- ALLO-715 + nirogacestat
- An Investigational New Drug (IND) application is expected to be submitted in the second half of 2020 to evaluate ALLO-715 in combination with SpringWorks’ investigational gamma secretase inhibitor, nirogacestat, in patients with relapsed/refractory MM.
- ALLO-605 (TurboCAR™)
- The Company presented preclinical data on its internally developed TurboCAR™ technology platform at the
American Society of Gene & Cell Therapy(ASGCT) 23rd Annual Meeting in May. TurboCAR technology allows cytokine activation signaling to be engineered selectively into CAR T cells. TurboCAR has the potential to improve efficacy, overcome cell exhaustion, and reduce dosing requirements of AlloCAR T therapy.
- In 2021, an IND is expected to be submitted for the Company’s first TurboCAR candidate, ALLO-605, an investigational BCMA-directed AlloCAR T therapy for MM.
Solid Tumor AlloCAR T Program
- ALLO-316 (anti-CD70)
- The Company continues 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 with an IND planned by the end of 2020.
Construction continues on the Company’s state-of-the-art cGMP cell manufacturing facility in
Second Quarter Financial Results
- Research and development expenses were
$47.3 millionfor the second quarter of 2020, which includes $8.0 millionof non-cash stock-based compensation expense.
- General and administrative expenses were
$15.9 millionfor the second quarter of 2020, which includes $8.8 millionof non-cash stock-based compensation expense.
- Net loss for the second quarter of 2020 was
$61.0 million, or $0.53per share, including non-cash stock-based compensation expense of $16.8 million.
- In June, the Company closed on a follow-on offering that raised
$632.5 millionin gross proceeds prior to deducting underwriting discounts, commissions and offering expenses. This included the exercise in full by the underwriters of their option to purchase additional shares of common stock. As a result, the Company had $1.1 billionin cash, cash equivalents, and investments as of June 30, 2020.
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 and establish favorable benefit:risk with ALLO-501, ALLO-501A and ALLO-715 and present any data from the trials, clinical outcomes, which may materially change as patient enrollment continues and more patient data become available, the timing and ability to file an IND and initiate clinical trials of ALLO-316, ALLO-605 and the combination of ALLO-715 with SpringWorks’ nirogacestat, the ability to manufacture AlloCAR T™ therapies, including for use in clinical trials, the timing and ability to complete the
AlloCAR T™ and TurboCAR T™ are trademarks of
Allogene’s AlloCAR T programs utilize Cellectis technologies. ALLO-501 and ALLO-501A are anti-CD19 allogeneic CAR T (AlloCAR T™) therapies 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
||Six Months Ended
|Research and development||$||47,296||$||31,774||$||89,337||$||55,177|
|General and administrative||15,862||14,187||31,502||27,245|
|Total operating expenses||63,158||45,961||120,839||82,422|
|Loss from operations||(63,158||)||(45,961||)||(120,839||)||(82,422||)|
|Other income (expense), net:|
|Interest and other income, net||2,340||4,559||5,600||9,384|
|Total other income (expense), net||2,184||4,559||5,385||9,384|
|Loss before income taxes||(60,974||)||(41,402||)||(115,454||)||(73,038||)|
|Benefit from income taxes||—||159||—||209|
|Net loss per share, basic and diluted||$||(0.53||)||$||(0.41||)||$||(1.03||)||$||(0.74||)|
|Weighted-average number of shares used in computing net loss per share, basic and diluted||115,377,210||99,846,946||112,163,123||98,588,410|
SELECTED BALANCE SHEET DATA
|Cash, cash equivalents and investments||$||1,110,444||$||588,855|
|Total stockholders’ equity||1,163,419||629,023|
Allogene Media/Investor Contact:
Chief Communications Officer
Source: Allogene Therapeutics, Inc.