ALX Oncology Q2 2024 Financial Results and Corporate Update

ALX Oncology Holdings Inc., a clinical-stage immuno-oncology company headquartered in South San Francisco, has revealed its financial results for the second quarter of 2024, alongside updates on its corporate progress. The company is advancing its lead product candidate, evorpacept, which targets the CD47 immune checkpoint pathway.

Jason Lettmann, CEO of ALX Oncology, highlighted the strides made in evorpacept’s development across various oncology indications. Notably, the ASPEN-06 Phase 2 clinical trial showed promising results for HER2-positive advanced gastric cancer, marking a pivotal growth milestone. Lettmann emphasized the company's robust position to build on these achievements and continue progressing towards future milestones.

Key Developments and Clinical Progress

Evorpacept Clinical Development

On July 31, ALX Oncology announced topline results from the ASPEN-06 Phase 2 trial, which tested evorpacept in combination with trastuzumab, CYRAMZA® (ramucirumab), and paclitaxel (Evo-TRP) for HER2-positive gastric/gastroesophageal junction (GEJ) cancer. All participants had previously received anti-HER2 therapy. The trial showed that evorpacept enhanced tumor response, marking the first instance of a CD47 blocker demonstrating a durable response in a prospective randomized study.

The primary study objective was to compare the overall response rate (ORR) of Evo-TRP against an assumed ORR of 30% for the control group (CYRAMZA and paclitaxel). Evo-TRP achieved a confirmed ORR of 40.3%, compared to 26.6% for the control arm, and demonstrated a median duration of response (mDOR) of 15.7 months against 7.6 months for the control.

In patients with fresh HER2-positive biopsies, Evo-TRP showed even greater efficacy, with an ORR of 54.8% compared to 23.1% for the control. This suggests a strong correlation between HER2 expression and evorpacept's effectiveness, validating its mechanism of action.

In June, the company presented data from the Phase 1 ASPEN-07 trial at the 2024 American Society of Cancer Oncology (ASCO) Annual Meeting. The trial evaluated evorpacept in combination with PADCEV® (enfortumab vedotin) in advanced urothelial cancer, demonstrating promising activity and tolerability.

Further, in April, ALX Oncology reported positive results from a Phase 1/2 trial combining evorpacept with standard treatments for relapsed or refractory B-cell non-Hodgkin lymphoma, achieving an ORR of 94% and a complete response rate (CRR) of 83%.

Additionally, a Phase 2 trial was initiated in collaboration with KEYTRUDA® (pembrolizumab) for untreated, early-stage, locally advanced human papillomavirus-mediated oropharyngeal cancer.

Financial Highlights

As of June 30, 2024, ALX Oncology's cash, cash equivalents, and investments totaled $186.2 million, expected to fund operations well into Q1 2026. R&D expenses for the second quarter were $34.7 million, up from $29.5 million in the same period in 2023. This increase was mainly due to higher preclinical costs, personnel expenses, stock-based compensation, and other research costs.

General and administrative (G&A) expenses were $6.9 million, slightly down from $7.3 million in the prior year, primarily due to a decrease in stock-based compensation. The GAAP net loss for the quarter stood at $39.4 million, or $0.76 per share, compared to $34.2 million, or $0.84 per share, a year earlier. The non-GAAP net loss was $32.1 million, compared to $27.9 million for the same period in 2023.

Strategic Appointments

The company bolstered its board and executive team with the addition of Alan Sandler, M.D., to its Board of Directors, and Allison Dillon, Ph.D., as Chief Business Officer.

Upcoming Milestones

ALX Oncology is set to achieve several key milestones in the coming months across various oncology indications related to evorpacept. These include:
- Topline results from Phase 2 trials in Head and Neck Squamous Cell Carcinoma with KEYTRUDA in the first half of 2025.
- Updated results from the ASPEN-06 Phase 2 trial in gastric/GEJ cancer and the ASPEN-07 Phase 1 trial in urothelial cancer, also expected in the first half of 2025.
- Initiation of a Phase 3 registrational trial for gastric/GEJ cancer by mid-2025.
- Topline results from a Phase 1b trial in breast cancer with ENHERTU® in the second half of 2025.

ALX Oncology remains focused on advancing its evorpacept pipeline to offer disruptive and effective cancer therapies.

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