Alx Oncology Holdings Inc Stock Price, News & Analysis

ALX Oncology (NASDAQ: ALXO) has announced details about ALX2004, their novel antibody-drug conjugate (ADC) designed to treat EGFR-expressing solid tumors. The drug has received FDA IND clearance and will begin clinical trials in mid-2025, with initial safety data expected in 1H 2026. ALX2004 features a unique design with an affinity-tuned EGFR antibody and proprietary linker-Top1i payload, engineered to maximize therapeutic effectiveness while reducing toxicity. Preclinical data shows superior stability compared to other ADCs, demonstrating dose-dependent activity across various tumors without significant EGFR-related skin toxicity. The Phase 1 trial will focus on patients with relapsed/refractory cancers, including non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma, and esophageal squamous cell carcinoma.

ALX Oncology (NASDAQ: ALXO) has announced a webcast event scheduled for May 20, 2025, focusing on ALX2004, their novel antibody-drug conjugate (ADC). The event will showcase ALX2004's mechanism of action, preclinical data, and clinical development strategy following FDA's IND clearance earlier this year.

ALX2004, developed in-house using the company's proprietary topoisomerase I inhibitor payload platform, is designed to target EGFR-expressing tumors. The presentation will feature key executives including CEO Jason Lettmann, CMO Alan Sandler, and VP of Antibody Technologies Marija Vrljic, who will discuss planned clinical progress and updates.

ALX Oncology (ALXO) reported Q1 2025 financial results and corporate updates. The company received FDA IND clearance for ALX2004, their novel EGFR-targeted antibody-drug conjugate, with clinical trials starting mid-2025. They're focusing on evorpacept development in combination with anti-cancer antibodies, with Phase 2 ASPEN-Breast and Phase 1 ASPEN-CRC studies starting mid-2025. The company won't pursue U.S. registration for gastric cancer after FDA feedback indicated accelerated approval isn't feasible. Financial highlights include cash position of $107.0 million, extending runway into Q4 2026. Q1 2025 showed reduced R&D expenses at $23.9M (down from $31.7M) and increased G&A expenses at $7.9M (up from $6.0M). Net loss improved to ($30.8M) compared to ($35.6M) in Q1 2024.

ALX Oncology Holdings (Nasdaq: ALXO), a clinical-stage biotechnology company focused on developing cancer therapies, has announced it will release its first quarter 2025 financial results on Thursday, May 8th, 2025, before the market opens. The company has specified that it will not hold a conference call to discuss the results.

ALX Oncology (ALXO) has announced final results from a Phase 1 trial evaluating evorpacept in combination with rituximab and lenalidomide (R2) for B-cell non-Hodgkin lymphoma. The study demonstrated promising outcomes with 83% complete response rate in indolent NHL patients, significantly higher than the 34% historical rate with R2 alone.

The trial enrolled 20 patients, including 18 with indolent and 2 with aggressive R/R B-NHL. Key findings include:

• Two-year progression-free survival rate of 69%
• Two-year overall survival rate of 84%
• 90% best overall response rate
• Well-tolerated treatment with no dose-limiting toxicities

The Phase 2 portion of the trial in previously untreated indolent NHL patients has completed enrollment. Results will be presented at the AACR 2025 Annual Meeting.

ALX Oncology (ALXO) announced that its Phase 2 ASPEN-03 and ASPEN-04 clinical trials for evorpacept in combination with Merck's KEYTRUDA® did not meet primary endpoints for treating head and neck squamous cell carcinoma (HNSCC). The trials evaluated improved objective response rates compared to historical controls.

Despite encouraging trends in ASPEN-03, the company will discontinue pursuing evorpacept with pembrolizumab in HNSCC. However, ALX Oncology will continue multiple clinical trials of evorpacept combined with anti-cancer antibodies, citing positive results in HER2-positive gastric and breast cancer trials.

The company remains focused on evorpacept's primary mechanism of action - blocking the CD47 'don't eat me' signal on cancer cells - and its ongoing evaluation in colorectal cancer, breast cancer, non-Hodgkin lymphoma, and multiple myeloma trials.

ALX Oncology (ALXO) has received FDA clearance for its Investigational New Drug (IND) application for ALX2004, a potential first-in-class antibody-drug conjugate (ADC) for treating EGFR-expressing solid tumors. The company plans to initiate Phase 1 clinical trials in mid-2025, with initial safety data expected in 1H 2026.

ALX2004, developed entirely in-house using the company's proprietary linker-payload platform, targets EGFR - a transmembrane protein overexpressed in various cancers including breast, colorectal, head and neck, and non-small cell lung cancer. The drug is designed to optimize targeted delivery of chemotherapy to tumor cells while minimizing systemic toxicity.

The molecule features an engineered antibody backbone for optimized anti-EGFR activity, enhanced stability linker, and a proprietary topoisomerase I payload capable of generating an enhanced bystander effect. An R&D call focused on ALX2004 is planned for Q2 2025.

ALX Oncology (ALXO) reported its Q4 and full year 2024 financial results, highlighting positive clinical developments for evorpacept. The ASPEN-06 Phase 2 trial showed promising results in HER2-positive gastric cancer, with a 48.9% confirmed objective response rate versus 24.5% in the control group.

The company announced strategic prioritization efforts, including a 30% workforce reduction, extending cash runway into Q4 2026. Cash position stood at $131.3 million as of December 31, 2024. Q4 2024 showed reduced losses with GAAP net loss of $29.2 million ($0.55 per share) compared to $45.5 million ($0.93 per share) in Q4 2023.

Key upcoming milestones include topline results from ASPEN-03 and ASPEN-04 trials in Q2 2025, and new clinical trials in breast and colorectal cancers starting mid-2025. R&D expenses decreased to $23.5 million in Q4 2024 from $41.8 million in the prior year period.

ALX Oncology (ALXO) announced key updates during its R&D Day webcast event, highlighting the advancement of its clinical pipeline. The company is focusing on the development of evorpacept, a CD47-blocker, and introducing new clinical trials in breast and colorectal cancers expected to start in H1 2025.

The company revealed plans to submit an IND application for ALX2004, their novel EGFR-targeted antibody-drug conjugate (ADC) candidate, in Q1 2025. ALX2004 has shown potent anti-tumor activity in multiple xenograft models.

In a strategic move, ALX Oncology announced a 30% workforce reduction, primarily affecting preclinical research functions, as part of resource optimization efforts. This restructuring, along with decreased preclinical research investments, is expected to extend the company's cash runway into Q4 2026.