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 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]

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]

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]

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.