On May 9, 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 first quarter ended March 31, 2022 and provided clinical development and operational highlights (Press release, ALX Oncology, MAY 9, 2022, View Source [SID1234613989]).

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"Throughout the first quarter, we continued to realize significant progress advancing our lead program, evorpacept, through multiple clinical trials," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "Our highlights include dosing the first patient in ASPEN-06, our Phase 2/3 study testing evorpacept in combination with ramucirumab, trastuzumab, and paclitaxel for the treatment of patients with HER2-positive gastric cancer or gastroesophageal junction ("GEJ") cancer and the U.S. Food and Drug Administration ("FDA") granting Orphan Drug Designation ("ODD") to evorpacept for the treatment of patients with gastric/GEJ cancer."

"Looking ahead, we are excited for clinical milestones by year-end including the expected dose optimization readout of a Phase 1b clinical trial of evorpacept in combination with azacitidine in patients with myelodysplastic syndromes ("MDS") (ASPEN-02) and updates on our Phase 1/2 collaboration with Zymeworks in evaluating the combination of evorpacept and zanidatamab in patients with HER2-positive breast cancer and other solid tumors," Dr. Pons continued.

Recent Clinical Developments for Evorpacept

Initiation of a Phase 2/3 Study of Evorpacept for the Treatment of Patients with Advanced Gastric or Gastroesophageal Junction Cancer (ASPEN-06)
In March 2022, the first patient was dosed in the Phase 2/3 ASPEN-06 study evaluating the combination of evorpacept, a next generation CD47 blocker, 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/GEJ cancer.
ASPEN-06 (NCT05002127) is a randomized Phase 2 (open-label) / Phase 3 (double-blind), international, multi-center study to evaluate the efficacy of evorpacept in combination with ramucirumab, trastuzumab, and paclitaxel for the treatment of patients whose tumors have progressed following treatment with HER2-targeted therapy and chemotherapy. Approximately 450 adult patients will be enrolled in the study across both phases.
FDA Granted ODD for Evorpacept for the Treatment of Patients with Gastric/GEJ Cancer
In January 2022, ALX Oncology announced that the FDA granted ODD to evorpacept, a next-generation CD47 blocker, for the treatment of patients with gastric/GEJ cancer.
Recent Corporate Updates

Appointed Itziar Canamasas, Ph.D., to its Board of Directors
In April 2022, ALX Oncology announced the appointment of Itziar Canamasas, Ph.D., to its Board of Directors (the "Board"). With more than 20 years of biopharmaceutical industry experience, Dr. Canamasas brings expertise in driving business growth and operational excellence.
First Quarter 2022 Financial Results:

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of March 31, 2022 were $341.7 million. ALX Oncology believes its cash, cash equivalents and investments are sufficient to fund planned operations through mid-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 March 31, 2022, were $17.1 million, compared to $9.8 million for the prior-year period. The increase in expenses during the three months ended March 31, 2022 compared to the three months ended March 31, 2021 were primarily attributable to an increase of $2.6 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 evorpacept, as well as an increase of $0.9 million related to the collaboration with Tallac Therapeutics, Inc., an increase of $2.1 million in personnel related costs driven by headcount growth, an increase of $1.5 million in stock-based compensation expense due to additional awards granted since March 31, 2021 and an increase of $0.6 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: 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 March 31, 2022, were $7.7 million, compared to $4.4 million for the prior-year period. The expense increases during the three months ended March 31, 2022 compared to the three months ended March 31, 2021 were primarily attributable to an increase of $2.2 million in stock-based compensation expense due to additional awards granted since March 31, 2021 and an increase of $0.8 million in other costs primarily driven by an increase in corporate legal fees, regulatory related filing fees and facility and information technology costs.
Net loss: GAAP net loss was $24.5 million for the first quarter ended March 31, 2022, or $0.60 per basic and diluted share, as compared to a net loss of $14.2 million for the first quarter ended March 31, 2021, or $0.35 per basic and diluted share. Non-GAAP net loss was $19.0 million for the first quarter ended March 31, 2022, as compared to a net loss of $12.4 million for the first quarter ended March 31, 2021. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.