8-K: ALX Oncology Reports Positive Phase 2 Trial Results and Provides Corporate Update

ALX Oncology announced positive results from its ASPEN-06 Phase 2 trial for evorpacept in gastric cancer and provided a corporate update for the second quarter of 2024.

Summary

• ALX Oncology reported its second quarter 2024 financial results and provided a corporate update.
• The company highlighted positive topline data from the ASPEN-06 Phase 2 clinical trial of evorpacept in combination with other therapies for HER2-positive gastric cancer.
• The trial showed an improved overall response rate (ORR) of 40.3% for the evorpacept combination compared to 26.6% for the control arm.
• The median duration of response (mDOR) was 15.7 months for the evorpacept combination versus 7.6 months for the control arm.
• In a subset of patients with fresh HER2-positive biopsies, the ORR for the evorpacept combination was 54.8% compared to 23.1% in the control arm.
• ALX Oncology also presented data from the ASPEN-07 Phase 1 trial of evorpacept with an antibody-drug conjugate (ADC) in urothelial cancer at the ASCO Annual Meeting.
• Additionally, positive data was reported from a Phase 1/2 trial of evorpacept in B-cell non-Hodgkin lymphoma, showing a 94% best ORR and 83% complete response rate in indolent R/R B-NHL.
• The company initiated a Phase 2 investigator-sponsored trial of evorpacept in oropharyngeal cancer.
• Cash, cash equivalents, and investments totaled $186.2 million as of June 30, 2024, which is expected to fund operations into Q1 2026.
• Research and development expenses for the quarter were $34.7 million, compared to $29.5 million in the prior year period.
• The GAAP net loss for the quarter was $39.4 million, or ($0.76) per share, compared to a net loss of $34.2 million, or ($0.84) per share, in the same period last year.

Sentiment

Score: 8

Explanation: The document presents very positive clinical trial results, particularly in the ASPEN-06 trial, and the company has sufficient cash to fund operations into Q1 2026. The increase in R&D expenses and net loss are expected for a clinical-stage company, but the overall tone is optimistic.

Positives

• The ASPEN-06 Phase 2 trial demonstrated a statistically significant improvement in overall response rate and median duration of response for evorpacept in gastric cancer.
• The trial results suggest that HER2-expression strongly correlates with evorpacept efficacy.
• The Phase 1/2 trial in B-cell non-Hodgkin lymphoma showed very high response rates.
• The company has sufficient cash to fund operations into Q1 2026.
• The company is advancing multiple clinical trials across various oncology indications.

Negatives

• The company reported a GAAP net loss of $39.4 million for the quarter.
• Research and development expenses increased by $5.2 million compared to the same period last year.
• The secondary endpoints of PFS and OS in the ASPEN-06 trial were immature at the time of analysis.

Risks

• The company is subject to risks and uncertainties related to clinical trials, regulatory approvals, and market acceptance of its products.
• The company's future financial performance depends on the success of its clinical development programs.
• The company may need to raise additional capital in the future to fund its operations.

Future Outlook

The company anticipates numerous milestones across multiple oncology indications in its evorpacept clinical development program, including topline results from several Phase 2 trials and the initiation of a Phase 3 registrational trial. The company believes its current cash reserves are sufficient to fund operations well into Q1 2026.

Management Comments

• Our team continues to make significant progress in the advancement of our evorpacept development pipeline across multiple oncology indications, said Jason Lettmann, Chief Executive Officer of ALX Oncology.
• Data readouts across our Phase 1 and 2 clinical trials highlight the potential of evorpacept as a disruptive therapy in combination with anti-cancer antibodies and ADCs.
• We are well positioned to build on our second quarter achievements and continue to advance toward our anticipated milestones in the months ahead.

Industry Context

The announcement highlights the ongoing development of CD47-blocking therapies in the immuno-oncology space, where there is significant interest in novel approaches to cancer treatment. The positive results from the ASPEN-06 trial position ALX Oncology as a potential leader in this area, particularly in the treatment of HER2-positive gastric cancer.

Comparison to Industry Standards

• The 40.3% ORR in the ASPEN-06 trial compares favorably to the assumed 30% ORR for the control arm, and the observed 26.6% ORR in the control arm, suggesting a clinically meaningful benefit from evorpacept.
• The 15.7 month mDOR for the evorpacept combination is significantly longer than the 7.6 months in the control arm, indicating a durable response.
• The 94% best ORR and 83% complete response rate in the B-cell non-Hodgkin lymphoma trial are very high compared to historical benchmarks for rituximab and lenalidomide, which had a 34% CRR.
• These results position evorpacept as a potentially competitive therapy in the CD47 inhibitor space, which includes companies like Forty Seven (acquired by Gilead) and Trillium Therapeutics (acquired by Pfizer), although direct comparisons are difficult due to different trial designs and patient populations.

Management Changes

Stakeholder Impact

• Shareholders will likely react positively to the strong clinical trial results and the company's financial stability.
• Employees may be motivated by the progress of the company's clinical programs.
• Patients with cancer may benefit from the development of new treatment options.
• The company's suppliers and partners may see increased business opportunities.

Next Steps

• The company plans to release topline results from ASPEN-03 and ASPEN-04 trials in the first half of 2025.
• Updated results from ASPEN-06 and ASPEN-07 trials are expected in the first half of 2025.
• The company plans to initiate a Phase 3 registrational trial for evorpacept in gastric/GEJ cancer in mid-2025.
• Topline results from the Phase 1b I-SPY TRIAL with ENHERTU are expected in the second half of 2025.

Key Dates

Keywords

evorpacept, CD47, immuno-oncology, gastric cancer, HER2-positive, clinical trial, antibody-drug conjugate, urothelial cancer, non-Hodgkin lymphoma, R&D expenses