ALX Oncology Q1 2024 Financial Results and Corporate Update

SOUTH SAN FRANCISCO, Calif., May 09, 2024 – ALX Oncology Holdings Inc., a company specializing in immuno-oncology therapies, has announced its financial results for the first quarter ending March 31, 2024, alongside a corporate update. The organization, which trades on Nasdaq under the ticker ALXO, focuses on developing treatments that target the CD47 immune checkpoint pathway.

In the first quarter, the company built on the momentum from the previous year, when it reported positive results from a Phase 2 clinical trial of its primary asset, evorpacept, in patients with advanced HER2-positive gastric or gastroesophageal junction cancer. This achievement marked the first instance of a CD47 blocker demonstrating anti-tumor activity in a global randomized study involving solid tumors. CEO Jason Lettmann highlighted that the company's primary focus during the quarter was on ensuring optimal execution of its clinical and operational strategies.

Key developments in the first quarter included the presentation of positive data from a Phase 1/2 clinical trial of evorpacept combined with standard treatments in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The study showed promising results, with a 94% overall response rate and an 83% complete response rate in indolent cases. The clinical trial was conducted and sponsored by the University of Texas MD Anderson Cancer Center.

Additionally, ALX Oncology received acceptance of two abstracts related to evorpacept for the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting. These abstracts cover the combination of evorpacept with enfortumab vedotin in patients with advanced urothelial carcinoma and a Phase 2 study of evorpacept, cetuximab, and pembrolizumab in patients with refractory metastatic colorectal cancer. The company also initiated a Phase 2 trial of neoadjuvant radiation and evorpacept combined with KEYTRUDA in patients with early-stage, resectable human papillomavirus-mediated oropharyngeal cancer. This trial is sponsored by the University of California, San Diego.

The company also appointed Allison Dillon, Ph.D., as Chief Business Officer. Upcoming clinical milestones for evorpacept include data releases from various ongoing trials, including studies in urothelial carcinoma, gastric/gastroesophageal junction cancer, breast cancer, and head and neck squamous cell carcinoma. The initiation of a Phase 3 registrational randomized clinical trial for evorpacept in gastric/GEJ cancer is also planned for late 2024.

Financially, ALX Oncology reported that as of March 31, 2024, it had $184.5 million in cash, cash equivalents, and investments. The company also raised an additional $26.2 million through an at-the-market offering. These funds, along with the ability to draw down an additional $40 million of its term loan, are expected to sustain operations into the first quarter of 2026.

Research and development expenses for the first quarter were $31.7 million, up from $24.8 million in the same period the previous year. This increase was primarily due to higher clinical development costs, expanded patient enrollment, and increased manufacturing expenses for clinical trial materials. General and administrative expenses were $6.0 million, down from $7.4 million in the prior year, mainly due to a reclassification of stock-based compensation expenses.

The company reported a GAAP net loss of $35.6 million for the quarter, compared to a net loss of $30.2 million in the same period of 2023. The non-GAAP net loss was $28.5 million, compared to $23.8 million in the prior year.

ALX Oncology's lead product candidate, evorpacept, is designed to block the CD47 immune checkpoint and has shown promising activity and a favorable safety profile in various clinical trials. The company aims to combine evorpacept with anti-cancer antibodies, antibody-drug conjugates, and PD-1/PD-L1 inhibitors to enhance cancer treatment efficacy.