ALX Oncology Announces Q3 2024 Financial Results and Corporate Update

ALX Oncology Holdings Inc., a clinical-stage biotechnology firm based in South San Francisco, announced its third-quarter financial results for 2024 and provided significant corporate updates. The company, which is listed on Nasdaq under the ticker ALXO, focuses on developing cancer treatments that enhance the immune system.

Progress in Clinical Trials:
ALX Oncology's lead candidate, evorpacept, achieved a notable milestone by becoming the first CD47-blocking agent to show a durable clinical benefit and a favorable safety profile in the ASPEN-06 Phase 2 trial. This trial evaluated evorpacept in combination with HERCEPTIN, CYRAMZA, and paclitaxel (Evo-TRP) against a control group using trastuzumab, CYRAMZA, and paclitaxel (TRP) for patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer. The results were promising, with the Evo-TRP combination showing a confirmed overall response rate (ORR) of 40.3% compared to 26.6% for the control group. The median duration of response was 15.7 months for Evo-TRP, significantly longer than the 7.6 months for the control group in the intent-to-treat population.

In a specific subset of patients with fresh HER2-positive biopsies, the Evo-TRP combination demonstrated an ORR of 54.8%, compared to 23.1% in the control arm. Additionally, ALX Oncology began dosing patients in a trial to investigate evorpacept in combination with SARCLISA and dexamethasone for relapsed or refractory multiple myeloma (RRMM) as part of a study partnered with Sanofi. This study aims to evaluate the safety, efficacy, pharmacokinetics, and biomarker data of the drug combination.

Corporate Developments:
The company bolstered its leadership by appointing Dr. Alan Sandler to its Board of Directors. With over three decades of experience in oncology and drug development, Dr. Sandler's background includes roles such as Executive Vice President and Chief Medical Officer at Mirati Therapeutics, and President of Global Head of Development in Oncology at Zai Lab.

Financial Overview:
For the third quarter of 2024, ALX Oncology reported cash, cash equivalents, and investments totaling $162.6 million, which is expected to fund operations well into the first quarter of 2026. Research and development expenses for this period were $26.5 million, a decrease from $45.8 million in the same period of the previous year. This reduction was primarily due to lower costs associated with clinical trial materials manufacturing for evorpacept, though there were slight increases in preclinical costs, personnel expenses, and stock-based compensation.

General and administrative expenses also saw a decrease, totaling $6.1 million compared to $7.5 million in the prior-year period. This reduction was mainly due to lower stock-based compensation and accounting consulting costs. The net loss for the third quarter was $30.7 million, or $0.58 per share, compared to a net loss of $51.0 million, or $1.24 per share, in the third quarter of 2023. On a non-GAAP basis, the net loss was $23.7 million, compared to $44.0 million for the same period in 2023.

Upcoming Milestones:
ALX Oncology has outlined several anticipated milestones for evorpacept's development pipeline. These include results from a Phase 1b/2 trial in metastatic breast cancer, updated results from the ASPEN-06 Phase 2 trial in gastric/GEJ cancer, and topline results from Phase 2 trials in head and neck squamous cell carcinoma with KEYTRUDA. Additional updates will include results from a Phase 1 trial in urothelial cancer and the initiation of a Phase 3 registrational trial for evorpacept in gastric/GEJ cancer.

ALX Oncology continues to advance its mission to develop therapies that enhance the immune system's ability to combat cancer, with evorpacept showing promise across various cancer types.