Core Viewpoint - ALX Oncology Holdings Inc. has announced the pricing of an underwritten offering of common stock and pre-funded warrants, aiming to raise approximately $150 million to support its clinical development programs and general corporate purposes [1][3]. Group 1: Offering Details - ALX Oncology is selling 76,979,112 shares of common stock at an offering price of $1.57 per share and pre-funded warrants to purchase 18,574,120 shares at $1.569 each [1]. - The gross proceeds from the offering are expected to be around $150 million before deducting underwriting discounts and commissions [1]. - The offering is expected to close on or about February 2, 2026, subject to customary closing conditions [1]. Group 2: Investors and Participation - The financing is led by new investors RA Capital Management and TCGX, with participation from various other investors including 5AM Ventures, Blackstone Multi-Asset Investing, and others [2]. Group 3: Use of Proceeds - The net proceeds from the offering will be used to fund the continued clinical development of evorpacept and the ALX2004 program, as well as for working capital and other general corporate purposes [3]. Group 4: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with its lead candidate evorpacept currently in multiple clinical trials [6]. - The second pipeline candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate undergoing a Phase 1 dose-escalation trial in patients with EGFR-expressing solid tumors [6].

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]

Core Insights - ALX Oncology announced new data from a Phase 1b/2 clinical trial evaluating the investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals' ZIIHERA® for metastatic breast cancer, reinforcing CD47 as a predictive biomarker for treatment response [1][2] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with its lead candidate evorpacept showing potential as a cornerstone therapy in immuno-oncology [5] Clinical Trial Findings - The Phase 1b/2 trial demonstrated promising anti-tumor activity and a manageable safety profile, with a confirmed objective response rate of 56% and a median progression-free survival of 7.4 months in heavily pretreated HER2-positive breast cancer patients [2][3] - Additional exploratory analysis indicated that responses were primarily observed in patients with higher CD47 expression, supporting the predictive biomarker role of CD47 [3] Future Directions - The company plans to adopt a biomarker-driven approach for patient selection in future trials, particularly for combinations of evorpacept with HER2-targeted agents, and is confident in the ongoing ASPEN-09-Breast Phase 2 trial [2]

Core Insights - ALX Oncology has had a significant year, with seven different data sets read out, indicating strong progress in its clinical programs [2] - The company is focused on developing two clinical stage programs, evorpacept and ALX2004, which are differentiated within their class [2] - Evorpacept targets CD47, a crucial element in the immune system and oncology, which has historically been challenging to address [2]

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]

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.