SOUTH SAN FRANCISCO, Calif., Jan. 30, 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 the pricing of an underwritten offering of common stock and pre-funded warrants. ALX Oncology is selling 76,979,112 shares of common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase 18,574,120 shares of ...

Core Insights - ALX Oncology announced new data from a Phase 1b/2 clinical trial evaluating the CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals' ZIIHERA® for metastatic breast cancer, reinforcing CD47 as a predictive biomarker for treatment response [1][2] Group 1: Clinical Trial Findings - The Phase 1b/2 trial demonstrated promising anti-tumor activity and a manageable safety profile in heavily pretreated HER2-positive breast cancer patients, with a median of six prior therapies [2] - The combination treatment achieved a confirmed objective response rate (cORR) of 56% (5 out of 9 patients) and a median progression-free survival (mPFS) of 7.4 months [2] - Additional exploratory analysis indicated that responses were largely restricted to patients with higher CD47 expression, supporting findings from the ASPEN-06 trial [3] Group 2: Future Directions - The company plans to adopt a biomarker-driven approach for patient selection in future trials involving evorpacept and HER2-targeted agents [2] - Full biomarker analysis from the Phase 1b/2 trial has been submitted for presentation at an upcoming scientific congress [4] Group 3: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with evorpacept as a lead candidate [5] - The company is also advancing a second pipeline candidate, ALX2004, which is currently in a Phase 1 trial for EGFR-expressing solid tumors [5]

- Exploratory analysis from Phase 1b/2 breast cancer trial reinforces CD47 as a predictive biomarker for response, as previously observed in the ASPEN-06 trial in HER2-positive gastric cancer – - Full data set submitted for presentation at an upcoming scientific conference - SOUTH SAN FRANCISCO, Calif., Jan. 30, 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 ...

PresentationGood afternoon. Thank you all for joining us here today. My name is Henry Jiang. I'm with the banking team here at JPMorgan, and it's my pleasure to be introducing ALX Oncology today. Joining us on stage and presenting today will be Jason Lettmann, CEO; as well as Barbara Klencke, Chief Medical Officer. Just a reminder that we'll have time for questions at the end of the session. So please wait until then for any questions, and we'll get you a microphone. But without further ado, I'll pass it ov ...

Summary of ALX Oncology FY Conference Call Company Overview - **Company**: ALX Oncology (NasdaqGS:ALXO) - **Key Programs**: Evorpacept and ALX 2004, both in clinical stages and differentiated in their class [2][3] Core Industry Insights - **Focus on CD47**: Evorpacept targets CD47, a critical immune checkpoint in oncology, which has been challenging to target effectively [3][4] - **EGFR-targeted ADC**: ALX 2004 is a novel antibody-drug conjugate (ADC) targeting EGFR, designed to minimize on-target toxicity while maximizing efficacy [21][22] Key Data and Findings - **Evorpacept Data**: - Presented at SITC with promising results in gastric cancer (Aspen-06) showing a 65% response rate in CD47 overexpressing HER2-positive patients, a significant improvement over the control arm [12][14] - Combination studies with Rituxan and Evorpacept showed complete response rates of 83% and 92% in different settings [13] - **ALX 2004 Progress**: - Currently in phase one trials, with successful completion of initial dose cohorts and a focus on optimizing the linker payload for better delivery and efficacy [4][31] - Preclinical data indicates superior bystander effects and reduced toxicity compared to existing EGFR-targeted therapies [27][29] Market Opportunity - **HER2-positive Breast Cancer**: - Estimated addressable patient population of 20,000, with a market opportunity valued between $2 billion to $4 billion [20] - Current treatments show response rates of 15% to 20%, indicating a significant unmet need for effective therapies post-HER2 treatment [19] Strategic Collaborations - **Partnerships**: Collaborations with Sanofi for combination studies in multiple myeloma, leveraging the high expression of CD47 in hematologic malignancies [46][47] Future Catalysts - **Upcoming Data Releases**: - Interim data for Evorpacept expected in Q3 2026, which will be crucial for validating the biomarker-driven approach [33] - Continued dose escalation and data sharing for ALX 2004 to elucidate its safety profile [34] Conclusion - ALX Oncology is positioned to potentially lead in the CD47 and EGFR-targeted therapy spaces with differentiated mechanisms and promising clinical data, addressing significant unmet medical needs in oncology [35][36]

JP Morgan Healthcare Conference January 2026 NASDAQ GS ALXO This presentation concerns product candidates that are under clinical investigation, and which have not yet been approved for marketing by the U.S. Food and Drug Administration. These product candidates are currently limited by federal law to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated. This presentation also contains estimates and other statistical da ...

Evorpacept Program - ALX Oncology's Evorpacept is a leading CD47 program with a unique design and inactive Fc region, showing activity in five combinations and targeting a CD47 biomarker[8] - In HER2+ Gastric Cancer, the Overall Response Rate (ORR) increased from 26% with Trastuzumab + Ramucirumab + Paclitaxel to 65% with Evorpacept + Trastuzumab + Ramucirumab + Paclitaxel in the ASPEN-06 subset, a randomized Phase 2 trial[31] - In HER2+ Breast Cancer, the ORR was 56% with Evorpacept + Zanidatamab compared to a benchmark of 22% with Margenza® + Chemo[32] - In indolent NHL, the complete response rate improved from a Rituximab benchmark of 18% to 54% with Evorpacept + Rituximab[35] - The addition of Evorpacept reduced the risk of disease progression or death by 61% for patients with retained HER2+ disease and high CD47 expression (Hazard Ratio = 0.39)[46] - The addition of Evorpacept led to improved overall survival for patients with retained HER2+ and high CD47 expression (Hazard Ratio = 0.63)[49] - Approximately 20,000 addressable patients are CD47-high in 2L+ HER2+ Breast Cancer, representing a $2-4 billion market opportunity[73] ALX2004 Program - ALX2004 is a highly differentiated EGFR ADC in Phase 1 dose escalation, targeting EGFR-expressing tumors including NSCLC, CRC, HNSCC, and ESCC, with initial safety data anticipated in 1H 2026[8, 99] - Preclinical data supports dose-dependent activity and a differentiated safety profile for ALX2004, with no evidence of payload-related ILD in NHP toxicity studies[8, 82] - ALX Oncology's projected cash runway extends into Q1 2027, driving key milestones for both Evorpacept and ALX2004 programs[10, 105]

Core Insights - ALX Oncology Holdings Inc. is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment and improving patient survival [3] Group 1: Company Overview - ALX Oncology is advancing a pipeline that includes its lead candidate, evorpacept, which shows promise as a cornerstone therapy in immuno-oncology [3] - The company is also developing ALX2004, an EGFR-targeted antibody-drug conjugate, currently in a Phase 1 dose-escalation trial for patients with EGFR-expressing solid tumors [3] Group 2: Upcoming Events - ALX Oncology will participate in the 44th Annual J.P. Morgan Healthcare Conference, with a corporate presentation scheduled for January 15, 2026, at 12:00 p.m. Pacific Time [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for up to 90 days post-event [2]

Group 1 - ALX Oncology Holdings Inc. 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 the 44th Annual J.P. Morgan Healthcare Conference, with a presentation scheduled for January 15, 2026, at 12:00 p.m. Pacific Time [1] - ALX Oncology's lead candidate, evorpacept, is being evaluated in multiple clinical trials across various cancer indications, aiming to establish a foundation for future immuno-oncology therapies [3] Group 2 - The second pipeline candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate currently undergoing a Phase 1, dose-escalation trial for patients with EGFR-expressing solid tumors [3] - Additional information about ALX Oncology can be found on their website and LinkedIn [3]

Core Insights - ALX Oncology has initiated the Phase 2 ASPEN-09-Breast trial for evorpacept in HER2-positive metastatic breast cancer, with interim analysis expected in Q3 2026 [1][5] - The Phase 1 trial for ALX2004 has progressed to the third dose cohort, with initial safety data anticipated in 1H 2026 [2][7] Group 1: Clinical Trials - The Phase 2 ASPEN-09-Breast trial will evaluate evorpacept in combination with trastuzumab and physician's choice of chemotherapy in 80 patients previously treated with ENHERTU [4] - The primary endpoint of the ASPEN-09-Breast trial is overall response rate (ORR) in HER2-positive patients confirmed by circulating tumor DNA (ctDNA) [5] - The Phase 1 trial for ALX2004 is a first-in-human study targeting EGFR-expressing solid tumors, currently enrolling patients in a dose escalation portion [6] Group 2: Drug Mechanisms and Efficacy - Evorpacept is the first CD47 inhibitor to show significant tumor response and a well-tolerated safety profile in a randomized trial, demonstrating benefits in patients with high CD47 expression levels [3] - ALX2004 aims to address toxicity challenges associated with earlier generation EGFR-targeted antibody-drug conjugates, with no dose-limiting toxicities observed in prior cohorts [2][7] Group 3: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel cancer therapies, with evorpacept as a lead candidate [8][9] - The company is advancing a pipeline of therapies designed to treat various cancer indications, with ongoing clinical trials for both evorpacept and ALX2004 [9]