On August 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 second quarter ended June 30, 2022 and provided clinical development and operational highlights (Press release, ALX Oncology, AUG 8, 2022, View Source [SID1234617773]).
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"The second quarter of 2022 was marked by substantial progress advancing our lead program, evorpacept, through multiple clinical trials," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "Notable accomplishments included the U.S. Food and Drug Administration ("FDA") granting Fast Track designation to evorpacept for the first-line treatment of adult patients with PD-L1 positive advanced head and neck squamous cell carcinoma ("HNSCC") in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, and Orphan Drug Designation ("ODD") to evorpacept for the treatment of patients with acute myeloid leukemia ("AML")."
"We continue to expand our clinical development efforts with the introduction of a new clinical study, ASPEN-07, a Phase 1 trial of evorpacept for the treatment of patients with urothelial carcinoma ("UC") and anticipate initiation in the fourth quarter of 2022. We are continuing enrollment in ASPEN-03 and ASPEN-04, two distinct Phase 2 studies for the treatment of patients with advanced HNSCC. In addition, we continue to advance ASPEN-06, our Phase 2/3 study testing evorpacept and CYRAMZA (ramucirumab), Eli Lilly and Company’s anti-VEGFR2 antibody, added to trastuzumab and paclitaxel for the treatment of patients with HER2-positive gastric cancer or gastroesophageal junction ("GEJ") cancer," Dr. Pons continued.
Recent Clinical Developments for Evorpacept
FDA Granted Fast Track Designation as First-Line Treatment for HNSCC
In August 2022, ALX Oncology announced that the FDA granted Fast Track designation to evorpacept, a next-generation CD47 blocker, in combination with KEYTRUDA (pembrolizumab) for the first-line treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC.
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 mid-2024.
FDA Granted ODD for Evorpacept for the Treatment of Patients with AML
In June 2022, ALX Oncology announced that the FDA granted ODD to evorpacept for the treatment of patients with AML.
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, has successfully completed enrollment with no safety concerns to date up to the highest protocol defined dose level of 60 mg/kg evorpacept once every four weeks.
Patient enrollment was paused before proceeding into the Phase 1 dose optimization portion of ASPEN-05 pending completion of the Phase 1 portion of ASPEN-02, a Phase 1/2 study of evorpacept in combination with azacitidine in patients with myelodysplastic syndrome ("MDS"). Data from ASPEN-02 will be used to inform the optimal dose(s) of evorpacept to be studied in the ASPEN-05 study in combination with venetoclax and azacitidine. Ongoing patients in ASPEN-05 will continue to be treated and followed per protocol.
Additional Evorpacept Clinical Program Updates
In June 2022, ALX Oncology announced expected initiation of ASPEN-07, a Phase 1 trial of evorpacept for the treatment of patients with UC. ASPEN-07 will investigate evorpacept in combination with an antibody-drug conjugate ("ADC"), PADCEV (enfortumab vedotin-ejfv), for the treatment of patients with UC in the fourth quarter of 2022.
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 CYRAMZA (ramucirumab) added to trastuzumab and paclitaxel for the treatment of patients with HER-positive gastric/GEJ 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.
Second Quarter 2022 Financial Results:
Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of June 30, 2022 were $324.2 million. ALX Oncology recently updated its cash forecast and believes its cash, cash equivalents and investments are sufficient to fund planned operations through the fourth quarter of 2024.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of ALX Oncology’s current lead product candidate, evorpacept, and R&D employee-related expenses. These expenses for the three months ended June 30, 2022, were $26.7 million, compared to $11.2 million for the prior-year period. The increase in expenses during the three months ended June 30, 2022 compared to the three months ended June 30, 2021 were primarily attributable to an increase of $10.3 million in clinical and development costs primarily due to 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 an increase of $1.6 million related to the Tallac Collaboration for work related to the IND filing planned for 2023; an increase of $0.4 million in preclinical costs primarily related to development of new targets; an increase of $1.8 million in personnel and related costs due primarily to an increase driven by headcount growth and a portion of a retention bonus payable to ScalmiBio stockholders; an increase of $2.0 million in stock-based compensation expense due to additional awards granted since June 30, 2021; and an increase of $1.1 million in other research costs.
General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended June 30, 2022, were $7.0 million, compared to $5.1 million for the prior-year period. The expense increases during the three months ended June 30, 2022 compared to the three months ended June 30, 2021 were primarily attributable to an increase of $1.6 million in stock-based compensation expense due to additional stock option awards granted since June 30, 2021 and an increase of $0.3 million in personnel and related costs primarily driven by headcount growth.
Net loss: GAAP net loss was $32.9 million for the second quarter ended June 30, 2022, or $0.81 per basic and diluted share, as compared to a net loss of $16.3 million for the second quarter ended June 30, 2021, or $0.40 per basic and diluted share. Non-GAAP net loss was $27.1 million for the second quarter ended June 30, 2022, as compared to a net loss of $14.0 million for the second quarter ended June 30, 2021. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.