On November 8, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported financial results for the third quarter ended September 30, 2022 and provided clinical development and operational highlights (Press release, ALX Oncology, NOV 8, 2022, View Source [SID1234623392]).
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"We continued to expand the clinical development of our lead program, evorpacept, during the third quarter of 2022, with the announcement of a new investigational treatment arm in the I-SPY-P1 TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer in partnership with Quantum Leap Healthcare Collaborative," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "With our recently announced non-dilutive term loan facility expected to extend our cash runway to mid-2025, we are focused on the advancement of evorpacept through multiple clinical milestones over the next two years."
Recent Clinical Developments for Evorpacept
Abstract Data for Phase 1 Dose Escalation Portion of ASPEN-05 Study in acute myeloid leukemia ("AML") Released as Part of the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Annual Meeting
In November 2022, ALX Oncology’s ASH (Free ASH Whitepaper) abstract was released online with initial results of the Phase 1 dose escalation portion of ASPEN-05, a Phase 1/2 clinical trial of evorpacept in combination with venetoclax and azacitidine for the treatment of patients with AML. Session 616: Poster III; Publication Number: 4076.
The results presented were as of July 8, 2022. 14 subjects were treated at evorpacept doses of 20 mg/kg Q2W (N=4), 30 mg/kg Q2W (N=4), and 60 mg/kg Q4W (N=6). The addition of evorpacept to standard dose venetoclax and azacitidine for AML was well tolerated with no maximum tolerated dose reached. Preliminary dose-proportional pharmacokinetics was seen along with full CD47 target occupancy in both peripheral blood and bone marrow across all dose levels evaluated. Initial anti-leukemic activity was observed in subjects with both newly diagnosed and relapse refractory AML. These initial results support further evaluation of evorpacept in myeloid malignancies, including AML.
A poster presentation from the dose escalation portion of ASPEN-05 with updated results will be presented at the ASH (Free ASH Whitepaper) Annual Meeting on Monday, December 12, 2022, 6:00pm to 8:00pm CT, at the Ernest N. Morial Convention Center, Hall D, New Orleans, LA.
Trials in Progress Abstracts Related to Data from ASPEN-03 and ASPEN-04 Clinical Trials Accepted for Poster Presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") 37th Annual Meeting
In October 2022, ALX Oncology announced the acceptance of two Trials in Progress abstracts related to ASPEN-03 and ASPEN-04, the Company’s Phase 2 head and neck squamous cell carcinoma ("HNSCC") studies which will be presented at SITC (Free SITC Whitepaper) in Boston, MA, from November 10–11, 2022 (abstracts 678 and 676).
ALX Oncology continues to advance ASPEN-03 and ASPEN-04, which are two distinct randomized Phase 2 studies for the treatment of patients with advanced HNSCC in combination with KEYTRUDA (pembrolizumab) with or without chemotherapy. Patient enrollment for ASPEN-03 and ASPEN-04 continues as planned with results expected to be presented by the middle of 2024.
Clinical Trial Agreement in Combination with ENHERTU (Fam-trastuzumab deruxtecan-nxki) Entered with Quantum Leap
In August 2022, ALX Oncology entered into a collaboration and supply agreement with Quantum Leap Healthcare Collaborative ("Quantum Leap") to evaluate evorpacept for a new investigational treatment arm in the I-SPY-P1 TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer.
Sponsored by Quantum Leap, this Phase 1 (open-label), multi-center study arm will investigate evorpacept in combination with ENHERTU (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody-drug conjugate, to determine the safety, tolerability and efficacy of this drug combination.
First Patient Dosed in Phase 2 Investigator-sponsored Trial of Evorpacept in Combination with ERBITUX (Cetuximab) and KEYTRUDA (Pembrolizumab) in Patients with Advanced Colorectal Cancer
In August 2022, ALX Oncology announced the initiation of a Phase 2 investigator-sponsored study of evorpacept in combination with ERBITUX (cetuximab) and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with refractory microsatellite stable metastatic colorectal cancer who have progressed on at least two lines of systemic therapy. This trial, managed by Criterium, Inc., is led by the Academic GI Cancer Consortium.
Additional Clinical Program Updates for Evorpacept
In June 2022, ALX Oncology announced the initiation of ASPEN-07, a Phase 1 trial of evorpacept for the treatment of patients with urothelial cancer ("UC"), with the first patient expected to be dosed in the fourth quarter of 2022. ASPEN-07 will investigate evorpacept in combination with an antibody drug conjugate, PADCEV (enfortumab vedotin-ejfv), for the treatment of patients with UC.
ALX Oncology continues to advance ASPEN-06, a randomized Phase 2 (open-label) / Phase 3 (double-blind), international, multi-center study to evaluate the efficacy of evorpacept and ramucirumab added to trastuzumab and paclitaxel for the treatment of patients with HER-positive gastric cancer or gastroesophageal junction cancer whose tumors have progressed following treatment with HER2-targeted therapy and chemotherapy. ASPEN-06 is being conducted in collaboration with Eli Lilly and Company. Patient enrollment continues to progress and results from the Phase 2 portion of ASPEN-06 are expected to be presented in 2023.
Recent Corporate Updates
Loan Facility Agreement with Oxford Finance LLC and Silicon Valley Bank of up to $100 Million of Non-dilutive Financing
In October 2022, ALX Oncology drew $10 million of an initial $50 million tranche at closing, with the remaining $40 million available at its discretion through the end of 2023. ALX Oncology also has access up to an additional $50 million with $12.5 million available in each of two tranches based upon the achievement of milestones related to the development of evorpacept and one pre-clinical product candidate, and $25 million available at the lenders’ discretion.
Third Quarter 2022 Financial Results:
Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments were $293.1 million as of September 30, 2022. ALX Oncology believes its cash, cash equivalents, investments and the ability to draw down up to $50 million of its term loan are sufficient to fund planned operations through mid-2025.
Research and Development ("R&D") Expenses: These expenses for the three months ended September 30, 2022 were $29.4 million, compared to $18.2 million for the prior-year period. Research and development expenses increased by $11.2 million during the three months ended September 30, 2022 compared to the three months ended September 30, 2021. The increase was primarily attributable to an increase of $6.0 million in clinical and development costs primarily due to clinical costs from an increase in the number of active trials and patient enrollment as well as manufacturing of clinical trial materials to support a higher number of active clinical trials and future expected patient enrollment related to the advancement of our lead product candidate, as well as expenses related to the Tallac Collaboration for costs related to the IND filing planned for 2023, an increase of $0.9 million in preclinical costs primarily related to development of new targets, an increase of $2.0 million in personnel and related costs primarily due to an increase driven by headcount growth and a portion of a retention bonus payable to ScalmiBio stockholders, an increase of $1.4 million in stock-based compensation expense due to additional awards granted since September 30, 2021 and an increase of $0.9 million in other research costs due primarily to an increase in facility costs related to the expansion of our new laboratory space.
General and Administrative ("G&A") Expenses: These expenses for the three months ended September 30, 2022 were $7.3 million, compared to $6.4 million for the prior-year period. General and administrative expenses increased by $0.9 million during the three months ended September 30, 2022 compared to the three months ended September 30, 2021. The increase was primarily attributable to an increase of $0.6 million in stock-based compensation expense due to additional stock option awards granted since September 30, 2021 and an increase in facility and information technology costs.
Net loss: GAAP net loss was $35.3 million for the third quarter ended September 30, 2022, or $0.87 per basic and diluted share, as compared to a net loss of $24.6 million for the third quarter ended September 30, 2021, or $0.61 per basic and diluted share. Non-GAAP net loss was $29.1 million for the third quarter ended September 30, 2022, as compared to a net loss of $20.4 million for the third quarter ended September 30, 2021. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.