Alx Oncology Holdings Inc. · NASDAQ:ALXO

Alx Oncology — Q2 2025 Earnings Presentation

33 slides from Alx Oncology's earnings presentation, Aug 12, 2025

  1. Slide 1: Q2 2025 Results

    Q2 2025 Results Jason Lettmann | Chief Executive Officer NASDAQ GS August 12, 2025 Jason Lettmann ALXO CEO, ALX Oncology © ALX Oncology Inc. All rights reserved.

  2. Slide 2: Forward-looking Statements

    Forward-looking Statements Certain information set forth in this presentation contains “forward-looking information”, under applicable laws collectively referred to herein as forward-looking statements. Except for statements of historical fact, information contained herein constitutes forward-lookin

  3. Slide 3: ALX Oncology Q2 2025 Results & Business Update

    Jason Lettmann Chief Executive Officer, ALX Oncology 01 Overview ALX Oncology 02 Clinical Development Update Q2 2025 Results & Alan Sandler, MD Chief Medical Officer, Business Update ALX Oncology Financials & Key 03 Milestones Harish Shantharam Chief Financial Officer, ALX Oncology 3

  4. Slide 4: ALX Oncology Q2 2025 Key Accomplishments and Updates

    ALX Oncology Q2 2025 Key Accomplishments and Updates Data from ASPEN-06 trial highlights CD47 expression as a key predictive biomarker, further  demonstrating compelling clinical response of evorpacept activity in HER2+ gastric cancer Phase 2 ASPEN-Breast evorpacept trial design updated to enable C

  5. Slide 5: CD47 expression acts as a predictive biomarker for durable patient benefit from evorpacept

    CD47 expression acts as a predictive biomarker for durable patient benefit from evorpacept ASPEN-06 HER2+ Gastric/GEJ Trial (ORR) CD47-High CD47-Low ITT Confirmed HER2+ Confirmed HER2+ 65%* Evorpacept + TRP TRP 41% 39% 27% 26% 25% N=63 N=64 N=20 N=23 N=23 N=24 CD47-high is ≥ 10% CD47 low is <10% cel

  6. Slide 6: Evorpacept: Uniquely designed to offer a differentiated safety profile and robust clinical activity

    Evorpacept: Uniquely designed to offer a differentiated safety profile and robust clinical activity in combination with available cancer therapies E V O R PA C E P T Higher affinity Inactive Fc Lower molecular Antibody-like CD47 binding domain weight pharmacokinetics More potently Less “sink effect”

  7. Slide 7: CD47 is overexpressed across a range of solid and heme malignancies

    CD47 is overexpressed across a range of solid and heme malignancies CD47 expression levels from RNA sequencing1 • As a ”marker of self”, CD47 is expressed on all cell types2 Median TPM • Cancer cells take advantage of this by overexpressing CD47 • Due to this, the vast majority of both solid and liq

  8. Slide 8: Research in CD47 over the last 10+ years provides a strong foundation

    Research in CD47 over the last 10+ years provides a strong foundation for utilizing CD47 as a negative prognostic biomarker Increased CD47 expression is correlated with poor patient outcomes in many tumor types including1:  Oral squamous cell carcinoma2  Nasopharyngeal carcinoma3 • In a meta-analy

  9. Slide 9: Evorpacept is the leading CD47 program in development

    Evorpacept is the leading CD47 program in development and now poised to be the next targeted immuno-oncology breakthrough Selecting for CD47 could lead to larger magnitude of effect and  increased probability of success in future studies Predictive CD47 biomarker could facilitate smaller and faster

  10. Slide 10: New data from ASPEN-06

    Evorpacept in patients with gastric cancer New data from ASPEN-06 on CD47 expression as a predictive Alan Sandler, MD biomarker for evorpacept CMO, ALX Oncology

  11. Slide 11: Evorpacept stimulates macrophages to selectively attack cancer cells

    Evorpacept, with its inactive Fc domain, stimulates macrophages to selectively attack cancer cells in combination with antibodies like Herceptin Evorpacept • Due to CD47 expression in healthy cells driving on-target toxicity, conventional approaches utilizing Fc-active CD47 antibodies have all faile

  12. Slide 12: Today: new analysis highlights CD47 expression as a key predictive biomarker

    Today: new analysis highlights CD47 expression as a key predictive biomarker further enhancing/increasing evorpacept activity in patients with gastric/GEJ cancer Primary endpoints in both ITT Key eligibility criteria and fresh biopsy populations • HER2+ GC or GEJ that has Evorpacept ITT patients (in

  13. Slide 13: As a reminder, Evo-TRP drove a 41% ORR

    As a reminder, Evo-TRP drove a 41% ORR compared to 27% in the TRP control arm in the ITT population Evo +T +R +P N=63 T +R +P N=64 ORR = 41.3% ORR = 26.6% (95% CI: 29%, 54%) (95% CI: 16%, 39%) mDOR = 15.7m mDOR = 9.1m (95% CI: 7.7m, NR) (95% CI: 5.3, NR) Evo Evorpacept T Trastuzumab R Ramucirumab P

  14. Slide 14: Evorpacept demonstrated a 49% ORR compared to control

    Furthermore, evorpacept demonstrated a 49% ORR compared to 24.5% in control in patients with HER2-positivity confirmed by fresh biopsy or ctDNA Patients with HER2+ confirmed with fresh biopsy OR ctDNA+ (n=96) Evo +T +R +P N=47 T +R +P N=49 Confirmed ORR = 48.9% Confirmed ORR = 24.5% (95% CI: 34.1%,

  15. Slide 15: Patients in ASPEN-06 were tested for both HER2 and CD47

    Patients in ASPEN-06 were tested for both HER2 and for CD47 expression ITT Patients enrolled with either a HER2+ fresh or archival biopsy N=127 HER2+ on a fresh Confirmed HER2+ biopsy1 or by n=96 ctDNA2 CD47 high CD47 low CD47 IHC assessment3 (≥10% IHC3+) (<10% IHC3+) n=43 n=47 43 patients were both

  16. Slide 16: CD47 expression acts as a predictive biomarker for durable benefit

    CD47 expression acts as a predictive biomarker for durable patient benefit from evorpacept ASPEN-06 HER2+ Gastric/GEJ Trial (ORR) CD47-High CD47-Low DOR, PFS and OS also ITT showed strong Confirmed HER2+ Confirmed HER2+ magnitude of benefit for 65%* evorpacept in CD47- Evorpacept + TRP high patients

  17. Slide 17: By targeting CD47-high patients, evorpacept is poised for breakthrough

    By targeting CD47-high patients, evorpacept is now poised to be the next targeted immuno-oncology breakthrough In patients with HER2+ and CD47-high gastric cancer (n=43), evorpacept +  TRP had a 65% ORR versus 26% ORR for TRP DOR, PFS and OS also showed strong magnitude of benefit between the  CD4

  18. Slide 18: Evorpacept in breast cancer

    ASPEN-Breast Evorpacept in breast cancer: CD47 biomarker strategy Alan Sandler, MD CMO, ALX Oncology

  19. Slide 19: The evorpacept opportunity in breast cancer

    The evorpacept opportunity in breast cancer Positive randomized data in ASPEN-06 in High De-risked path given gastric cancer with trastuzumab, and in Probability positive data in two combination with zanidatamab (HER2- of Success HER2-positive cancers bispecific) in HER2+ breast cancer Changing 1L S

  20. Slide 20: Phase 1b/2 trial evaluating evorpacept plus zanidatamab

    Phase 1b/2 trial evaluating safety and efficacy of evorpacept plus zanidatamab in patients with breast cancer who have progressed on prior HER2-directed therapy Key eligibility criteria Summary of baseline characteristics in Cohort 1 Unresectable, locally advanced and/or metastatic • Population repr

  21. Slide 21: Breast cancer patients with confirmed HER2-positivity had the greatest benefit

    Breast cancer patients with confirmed HER2-positivity had the greatest benefit from evorpacept + zanidatamab 100% Confirmed ORR in patients treated with 90% evorpacept + zanidatamab in Cohort 1 Strongest efficacy in confirmed 80% HER2+ 70% • ORR of 55.6% (5/9) Confirmed ORR • mDOR NE (range: 5.5-25.

  22. Slide 22: CD47 protein expression in HER2+ breast is over-expressed

    Several studies have found that CD47 protein expression in HER2+ Breast is over-expressed at time of initial diagnosis % BC % HER2+ BC Definition of Clone Ref CD47 High CD47 High High 89/200 (45%) 32/58 (55%) IRS 7-12 A1838 Alhanafy, 2024 • CD47 expression in breast cancer has 84/137 (61%) 16/24 (67

  23. Slide 23: CD47 is upregulated in response to T-DXd treatment

    CD47 is upregulated in response to T-DXd (Enhertu) treatment in HER2- positive breast cancer cell lines T-DXd (Enhertu) exposure increases CD47 expression • As our ASPEN-09 breast study will target post-Enhertu patients, these data provides validation that CD47 is a key mode of ADC evasion in the re

  24. Slide 24: CD47 expression in breast cancer is higher in HER2+ patients

    CD47 expression in breast cancer is higher in HER2+ patients, more common in resistant cancer CD47 expression is higher on … CD47-high cells are more HER2+ BC cells vs HER2- and… common in recurrent HER2+ BC Candas-green, et al, Nature Communications 2020 24 ALX Oncology Corporate Presentation

  25. Slide 25: Strong expected benefit enables evorpacept-attributable benefit in single-arm study

    Strong expected benefit in CD47-high and HER2+ patients enables evorpacept-attributable benefit in single-arm study Key eligibility criteria Key objectives  HER2+ mBC (IHC3+ or Primary IHC2+/ISH+) Evorpacept  ORR in HER2 ctDNA+ subpopulation  Measurable disease per N=80 RECIST 1.1 + Trastuzumab S

  26. Slide 26: HER2+ and CD47-high 2L+ BC represents a significant opportunity

    HER2+ and CD47-high 2L+ BC represents a significant initial commercial opportunity with potential to move into earlier lines of therapy 2L+ HER2+ 48K1 Confirmed HER2+ 60-80%2 ~20K addressable patients are CD47-high CD47 High Represents $2-4B 50-70% market opportunity in CD47- high, HER2+ 2L+ BC3 Ann

  27. Slide 27: ALX2004: potential best-in-class EGFR-targeted ADC

    ALX2004: potential best-in-class EGFR-targeted ADC First ADC from ALX’s linker payload platform

  28. Slide 28: ALX2004 is a highly differentiated ADC in development

    ALX2004 is a highly differentiated ADC in development for EGFR-expressing solid tumors now in Phase 1 trial 1 EGFR ADC internally developed by ALX’s world class protein engineers with track record of creating multiple FDA approved drugs 2 Each component rigorously designed to maximize therapeutic wi

  29. Slide 29: Phase 1 Clinical Development Plan

    Phase 1 Clinical Development Plan 01 Dose Escalation (Ph1a) 03 Dose Expansion (Ph1b) Enrolling | N = up to 40 N = up to 80 • Evaluate safety profile and recommend • Evaluate safety and efficacy in dose(s) and/or schedule(s) select tumor(s) • Target R/R patients • 1-2 tumor types • EGFR-expressing so

  30. Slide 30: Upcoming Catalysts from Pipeline

    FINANCIAL UPDATES AND MILESTONES Upcoming Catalysts from Pipeline Harish Shantharam, CFA CFO, ALX Oncology

  31. Slide 31: ALX Oncology is Pursuing a Focused Development Plan

    ALX Oncology is Pursuing a Focused Development Plan MODALITY IND /TARGET PROGRAM INDICATION ENABLING PHASE 1 PHASE 2 PHASE 3 STATUS EVORPACEPT PROGRAMS ASPEN-Breast ENHERTU®-Experienced HER2-Positive Breast Evorpacept, HERCEPTIN® FPI Q425 Cancer + chemotherapy Completed dose SARCLISA® + RRMM (Relaps

  32. Slide 32: ALX is Focused on Driving Toward Two Key Inflection Points in 2026

    ALX is Focused on Driving Toward Two Key Inflection Points in 2026 PROGRAM INDICATION AN TICIPATED MILESTONES E VO R PAC E PT ASPEN-Breast FPI Q4 2025 Evorpacept, HERCEPTIN® ENHERTU®-Experienced HER2-Positive Breast Cancer + chemotherapy Interim data – Q3 2026 ALX2004 ALX2004 FPI anticipated August

  33. Slide 33: ALXO

    NASDAQ GS ALXO © ALX Oncology Inc. All rights reserved.

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