SOUTH SAN FRANCISCO, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology"; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced its participation in the 44th Annual J.P. Morgan Healthcare Conference in San Francisco. Chief Executive Officer Jason Lettmann and Chief Medical Officer Barbara Klencke will deliver a corporate presentation on Thursday, January 15, 2026, at ...

SOUTH SAN FRANCISCO, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology"; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced its participation in the 44th Annual J.P. Morgan Healthcare Conference in San Francisco. Chief Executive Officer Jason Lettmann and Chief Medical Officer Barbara Klencke will deliver a corporate presentation on Thursday, January 15, 2026, at ...

- First patient dosed in Phase 2 ASPEN-09-Breast trial evaluating evorpacept in combination with trastuzumab and physician’s choice of chemotherapy in HER2-positive metastatic breast cancer; interim analysis anticipated Q3 2026 – - Third dose cohort initiated in Phase 1 trial of ALX 2004; study remains on track to provide initial safety data in 1H 2026 - SOUTH SAN FRANCISCO, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (“ALX Oncology,” Nasdaq: ALXO), a clinical-stage biotechnology co ...

Several biotechnology and healthcare companies posted notable gains in after-hours trading on Wednesday, driven by clinical updates, financial results, and upcoming industry presentations.ALX Oncology Holdings Inc. (ALXO) surged 10.17% to $1.30 after announcing positive data from a Phase 2 investigator-sponsored trial of its lead candidate, evorpacept. The therapy, combined with rituximab and lenalidomide, showed promise in patients with indolent B-cell non-Hodgkin lymphoma. The findings are scheduled to b ...

Core Insights - The combination of evorpacept, rituximab, and lenalidomide achieved a complete response (CR) rate of 92% in patients with untreated indolent non-Hodgkin lymphoma (iNHL), significantly higher than the historical CR rate of approximately 50% for rituximab alone [1][2] - The treatment regimen was well-tolerated and demonstrated impressive anti-tumor activity in the frontline setting, with a one-year progression-free survival (PFS) rate of 91% and a one-year overall survival (OS) rate of 100% [2] Study Details - The Phase 2 investigator-sponsored trial enrolled 24 patients, including 14 with follicular lymphoma and 10 with marginal zone lymphoma, and met the primary objective of achieving a CR rate above 80% [2] - The trial was led by Dr. Paolo Strati from The University of Texas MD Anderson Cancer Center, and the results were presented at the American Society of Hematology (ASH) Annual Meeting 2025 [3] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with evorpacept as its lead candidate [4] - The company is also advancing a second pipeline candidate, ALX2004, which is an EGFR-targeted antibody-drug conjugate currently in Phase 1 trials [5]

Summary of ALX Oncology Holdings FY Conference Call Company Overview - **Company**: ALX Oncology Holdings (NasdaqGS:ALXO) - **Founded**: 2015 - **Lead Program**: Evorpacept, a CD47 blocker with a unique mechanism of action - **New Program**: ALX 2004, an EGFR-targeted antibody-drug conjugate (ADC) currently in clinical trials [2][4] Core Points and Arguments CD47 Mechanism and Evorpacept - Evorpacept is designed to block the "don't eat me" signal from CD47, which is crucial for immune evasion by cancer cells [2][3] - The company claims to be the only CD47 blocker in development with a dead Fc, allowing for full blockade of the "eat me" signal [3] - The approach has been validated through four clinical studies, demonstrating its potential effectiveness [3] Clinical Trials and Results - **Gastric Cancer Trial**: - Phase 2 trial showed a 41% overall response rate (ORR) for evorpacept plus TRP compared to 26% in the control arm [9] - In patients retaining HER2 positivity, the response rate was 49% versus 25% in the control arm, with a median duration of response of 15.7 months [11] - The FDA did not grant accelerated approval due to the availability of Enhertu, leading the company to refocus on breast cancer [9][11] - **Breast Cancer Studies**: - The company is advancing a study combining evorpacept with Herceptin and chemotherapy, with interim data expected in Q3 2026 [16][17] - The study aims to evaluate efficacy based on CD47 expression levels [16] Biomarker Development - The company is developing a companion diagnostic to identify patients with high CD47 expression, which is crucial for treatment selection [15][16] - CD47 is recognized as a poor prognostic marker across various cancers, but its predictive use for treatment decision-making is still under development [15] ALX 2004 Development - ALX 2004 is an EGFR-targeting ADC developed in-house, with a focus on optimizing linker payloads and epitope selection to address past challenges in EGFR-targeted therapies [22][23] - The phase 1 trial is being conducted in multiple solid tumors, with initial safety data expected in the first half of 2026 [24][25] Competitive Landscape - The company believes it has a unique asset in ALX 2004, with a distinct epitope and linker payload compared to existing EGFR-targeted ADCs [25][26] - There is competition from various ADCs, particularly from China, but ALX Oncology claims to be first in treating U.S. patients with this specific approach [26] Financial Position and Future Outlook - The company has sufficient cash to support operations through Q1 2027, with several important milestones expected in the next 12 months [27] - Key upcoming events include safety data for ALX 2004 and interim data for the breast cancer study involving evorpacept [27] Additional Important Points - The company is exploring partnerships, particularly in Asia, to expand its market reach for gastric cancer treatments [14] - The strategic shift towards focusing on anti-cancer antibodies for evorpacept combinations reflects a response to clinical learnings over the past decade [5][6]

Summary of ALX Oncology Holdings Conference Call Company Overview - **Company**: ALX Oncology Holdings (NasdaqGS:ALXO) - **Focus**: The company has pivoted to focus on two high-value programs: evorpacept (a differentiated CD47 program) and ALX2004 (a novel EGFR targeted ADC) [4][5] Core Points and Arguments CD47 Program - **Mechanism**: Evorpacept provides full blockade of CD47, which is crucial for immune system communication. It combines with the Fc activity of antibodies to enhance macrophage activity [7][8] - **Clinical Data**: Strong results observed in gastric cancer patients with confirmed HER2 positivity, indicating a transformational benefit for patients with both HER2 positivity and high CD47 expression [8][12] - **Future Focus**: The company aims to validate the CD47 biomarker across various datasets, particularly in HER2-positive cancers [13][15] ALX2004 Program - **ADC Development**: ALX2004 is an EGFR targeted ADC with a unique linker payload and epitope designed to minimize on-target skin toxicity, a common issue with existing EGFR therapies [44][46] - **Clinical Progress**: The first patient was dosed in August, and the program is currently in the clinic with a focus on safety and early efficacy signals [43][55] Safety and Efficacy - **Safety Profile**: The dead Fc design of evorpacept has shown a favorable safety profile, allowing exploration in earlier treatment lines, including adjuvant and neoadjuvant settings [35][36] - **Efficacy Expectations**: The company aims for a response rate of 35% or more in double-positive patients in ongoing studies, which would validate their approach [24][31] Financial Outlook - **Cash Runway**: The company has a cash runway extending into early Q1 2027, focusing on the two clinical trials as priority [59] Other Important Content - **Regulatory Interactions**: The company has had discussions with the FDA regarding study design and is preparing for potential pivotal studies based on interim data [29][31] - **Market Positioning**: ALX Oncology is positioning itself in a competitive ADC landscape by leveraging unique scientific insights and a strong safety profile to differentiate its products [42][48] This summary encapsulates the key points discussed during the conference call, highlighting the strategic focus, clinical advancements, and financial positioning of ALX Oncology.

Core Insights - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment and improving patient survival [1][3] - The company will participate in two significant healthcare conferences: the Jefferies Global Healthcare Conference in London and the Piper Sandler 37th Annual Global Healthcare Conference in New York [1][2] Conference Details - Jefferies Global Healthcare Conference: - Format: Fireside Chat - Date: November 19, 2025 - Time: 11:30 AM GMT / 6:30 AM EST - Location: London, UK [2] - Piper Sandler 37th Annual Global Healthcare Conference: - Format: Fireside Chat - Date: December 3, 2025 - Time: 9:30 AM EST - Location: New York, NY [2] Company Pipeline - ALX Oncology's lead candidate, evorpacept, is positioned as a potential cornerstone therapy in immuno-oncology and is undergoing multiple clinical trials across various cancer indications [3] - The second candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate that began Phase 1 trials in August 2025 [3]

Core Insights - ALX Oncology Holdings Inc. is a clinical-stage biotechnology company focused on developing novel cancer therapies aimed at extending patients' lives [3] - The company will participate in two significant healthcare conferences: the Jefferies Global Healthcare Conference in London and the Piper Sandler 37 Annual Global Healthcare Conference in New York [1][2] Conference Details - Jefferies Global Healthcare Conference: - Format: Fireside Chat - Date: November 19, 2025 - Time: 11:30 AM GMT / 6:30 AM EST - Location: London, UK [2] - Piper Sandler 37 Annual Global Healthcare Conference: - Format: Fireside Chat - Date: December 3, 2025 - Time: 9:30 AM EST - Location: New York, NY [2] Company Pipeline - ALX Oncology's lead candidate, evorpacept, is being evaluated in multiple clinical trials across various cancer indications and is positioned as a cornerstone therapy for future immuno-oncology developments [3] - The second candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate that began Phase 1 trials in August 2025 [3]

Financial Data and Key Metrics Changes - The company reported a total cash balance of $67 million, which is expected to provide runway into Q1 2027, allowing the company to achieve upcoming value-enhancing data milestones for both ALX-2004 and evorpacept [6][44]. Business Line Data and Key Metrics Changes - Significant advances were made in both evorpacept and ALX-2004 clinical programs during Q3 2025, with a focus on evorpacept's potential as a targeted oncology therapy [4][12]. - The phase two clinical trial in breast cancer is on track to dose its first patient in Q4 2025, based on strong data supporting a CD47 and HER2 biomarker-driven strategy [5][12]. Market Data and Key Metrics Changes - The addressable patient population for HER2-positive breast cancer in the second-plus-line setting is approximately 48,000, with an estimated 20,000 patients being both HER2 positive and CD47 high, representing a market opportunity of $2 billion to $4 billion [38]. Company Strategy and Development Direction - The company is pursuing a focused development strategy for evorpacept in combination with anticancer antibodies, leveraging the consistent proof of concept seen in various clinical studies [13][44]. - ALX-2004 is positioned to redefine standard care across a range of EGFR-expressing cancers, with a strong emphasis on optimizing safety and efficacy [39][44]. Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the potential of evorpacept to drive substantial benefits for patients with high CD47 expression, emphasizing the importance of this biomarker in future trials [11][44]. - The company remains focused on delivering solutions for patients with unmet needs in both HER2-positive breast cancer and EGFR-expressing cancers [44][45]. Other Important Information - The company highlighted the unique mechanism of action of evorpacept, which is designed to block the CD47 signal that cancer cells use to evade immune detection, thus enhancing the effectiveness of anticancer therapies [15][44]. - ALX-2004 has shown promising preclinical data, indicating a differentiated safety profile and potential efficacy across various cancer types [40][41]. Q&A Session Summary Question: How to correlate CD47 positivity with expression cutoffs in gastric data? - Management noted strong scientific concordance across different indications, with approximately 50% of patients expected to be CD47 high based on multiple studies [46][47]. Question: Companion diagnostic development plans? - The company is working with partners for companion diagnostics, utilizing a research-use assay for both gastric and breast cancer studies [48]. Question: Efficacy data in breast cancer trials? - Management highlighted a 56% overall response rate in patients post-Enhertu, which is significantly higher than expected benchmarks [51][52]. Question: Expectations for interim data and patient numbers? - The company anticipates good outcome data in the evorpacept trial, aiming for a response rate of 35%-40% in the breast cancer setting [56].