ALXO
Published on 05/08/2026 at 08:31 am EDT
N A S D A Q - A L X O
May 2026
© ALX Oncology Inc. All rights reserved.
ALX Oncology
Jason Lettmann
Chief Executive Officer, ALX Oncology
Q1'26 Highlights
Breast Cancer Overview C ESMO CD47 Update
Sara Hurvitz, MD
Medical Oncologist,
Fred Hutch Cancer Center
Evorpacept and ALX2004 Program Update
Barb Klencke, MD
Chief Medical Officer, ALX Oncology
Closing Remarks
3 ALX Oncology Corporate Presentation
Evorpacept ALX2004
Leading CD47 program in development with potential to be next targeted immuno-oncology breakthrough
Unique design with inactive Fc differentiated from past attempts to target CD47
Demonstrated activity in five combinations to date and a targetable CD47 biomarker
Advancing trials in breast cancer and multiple myeloma*
Highly differentiated EGFR ADC in Ph1
dose escalation in the US
Meticulously designed and developed
in-house to maximize therapeutic window
Preclinical data support dose dependent activity and a differentiated safety profile
Targeting EGFR-expressing tumors in Ph1 including NSCLC, CRC, HNSCC, and ESCC
* Sanofi-sponsored trial; HNSCC: head and neck squamous cell carcinoma; CRC: colorectal cancer; NSCLC: non-small cell lung cancer; ESCC: esophageal squamous cell carcinoma
Data presented at ESMO Breast showed ALL patients who were confirmed HER2+/high CD47 expressers responded (ORR = 5/5) post T-DXd, with strong durability (mDOR = 20.2 m, mPFS = 22.1 m)
Data from two independent HER2+ cohorts meaningfully strengthens our confidence in the CD47 selection
hypothesis and derisks path forward in HER2+ breast cancer
Both evorpacept and ALX2004 clinical programs are advancing on schedule - topline evo data in mBC expected
mid-2027 and ALX2004 safety readout anticipated 2H 2026
$150M financing completed in Q1 '26 extends cash runway through 1H 2028; $169.1M in cash balance as of
Mar 31, 2026
Jeff Knight added as Chief Development C Operating Officer in April '26
P R O G R A M
I N D I C A T I O N
A N T I C I P A T E D M I L E S T O N E S
E V O R P A C E P T
ASPEN-Breast
Evorpacept, trastuzumab + chemotherapy
ENHERTU®-Experienced HER2-Positive
Topline data for 80 patients -
Breast Cancer
mid-2027
A L X 2 0 0 4
ALX2004
Dose-escalation and expansion
EGFR-Expressing Solid Tumors
Safety data from dose escalation
phase - 2H 2026
Projected Cash Runway through First Half of 2028
M O D A L I T Y
I N D
/ T A R G E T
P R O G R A M
I N D I C A T I O N
E N A B L I N G
P H A S E
1
P H A S E
2
P H A S E
3
S T A T U S
E V O R P A C E P T P R O G R A M S
Anti-Cancer Antibodies
ASPEN-0G-Breast
Evorpacept, Trastuzumab
+ chemotherapy
ENHERTU®-Experienced HER2-Positive Breast Cancer
Enrolling, topline data for 80 patients anticipated mid-2027
SARCLISA® +
Dexamethasone1 +
Evorpacept
RRMM
(Relapsed or Refractory Multiple Myeloma)
Dose escalation complete, now in dose optimization
ASPEN-06
Evorpacept, Trastuzumab, CYRAMZA® + Paclitaxel2
2L or 3L Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction (GEJ)
Ph2 completed, established POC
Zanidatamab3 + Evorpacept
HER2-Expressing Breast Cancer and Other Cancers
Completed, biomarker analysis presented at ESMO Breast Cancer 2026
A L X 2 0 0 4 P R O G R A M
EGFR ADC
ALX2004
Dose-escalation and expansion
EGFR-Expressing Solid Tumors
Enrolling, dose escalation phase safety data 2H 2026
ALX-Sponsored trial ● Active Trials ● Completed Trials
ALX Oncology retains worldwide rights to evorpacept; 1. Sanofi sponsors SARCLISA® clinical trial 2. Lilly supplies CYRAMZA® for ALX Oncology's ASPEN-06 program 3. Jazz Pharmaceuticals and ALX Oncology are collaborating to conduct the zanidatamab /evorpacept clinical trial
EVORPACEPT
Barb Klencke, MD Chief Medical Officer, ALX Oncology
SIRP Don't
M A C R O P H A G E
Eat Me
SIRP
Don't
M A C R O P H A G E
Eat Me
SIRP
Evorpacept
M A C R O P H A G E
CD47
CD47 CD47
C A N C E R C E L L
Eat Me
FcγR
C A N C E R C E L L
Target antigen
Anti-cancer antibody
Eat Me
FcγR
C A N C E R C E L L
Target antigen
Anti-cancer antibody
Cancer cells overexpress CD47 in order to evade immune detection
ADCP of anti-cancer antibodies is inhibited by CD47
Evorpacept blocks the "don't eat me"
signal and maximizes anti-cancer activity
SIRP
Eat me
R e d B l o o d
C e l l
CD47
γ
Conventional
Anti-CD47
M A C R O P H A G E
Conventional anti-CD47 with Active Fc
Due to CD47's expression on red blood cells,
this caused on-target, off-tumor toxicities
Evorpacept with Inactive Fc
Inactive Fc spares normal cells
minimizing toxicity
Senior Vice President and Director of Clinical Research Division, Fred Hutch
Professor Clinical Research Division, Fred Hutch
Professor and Head, Division of Hematology and Oncology Department of Medicine, University of Washington
Smith Family Endowed Chair in Women's Health, Fred Hutch
Steering Committee Member for ASPEN-0G Phase 2 Trial
Research Interests and Medical Expertise
Medical oncology management of breast cancer including early stage and late-stage disease, neoadjuvant treatments, novel targeted therapies against HER2, estrogen receptor positive and triple negative breast cancer
Preclinical and clinical evaluation of novel targeted and immune based therapies for breast cancer including HER2+ breast cancer, HER2-low breast cancer, triple negative breast cancer and hormone receptor positive breast cancer
EVORPACEPT
Sara Hurvitz, MD
Medical Oncologist,
Fred Hutch Cancer Center
HER2+ Metastatic Cancer Treatment Paradigm
1L
2L+
T-DXd (ENHERTU) + Pertuzumab (PERJETA) or
THP (Trastuzumab + Pertuzumab + Taxane)
ENHERTU + PERJETA is
new 1st line standard of
care in HER2+ mBC
Tucatinib + Trastuzumab + Capecitabine
T-DM1
Trastuzumab + Chemo
Trastuzumab + HER2 TKI
Other HER2-Targeted Therapy
Significant unmet need exists and will increase for patients whose disease has progressed on or after ENHERTU
Evorpacept + zanidatamab has demonstrated activity in ENHERTU experienced patients
No Clear Standard of Care Established for Patients Who Experience Progression on ENHERTU
Outcomes from First Post-ENHERTU Treatment1
Median PFS
4.1 months
(95% CI: 3.9, 4.5)
Lack of effective options post ENHERTU treatment is now one of the most important unmet needs in treating HER2+ breast cancer
Median real-world ORR for patients after receiving ENHERTU was 14.5%1
Median real-world PFS from two recent studies was 4.1 -
4.6 months1,2
(1) Nozawa, et al, Effectiveness of post-trastuzumab deruxtecan treatments and incidence of interstitial lung disease in HER2-positive metastatic breast cancer: a real-world, observational cohort
HER2-Directed Therapies
(Approved / In late-stage development)
IO Therapies
(In late-stage development)
HER2-Targeted Antibodies/Bispecifics
Trastuzumab • Margetuximab
Pertuzumab • Zanidatamab
HER2-Targeted ADCs
T-DXD • ARX-788
T-DM1
HER2-Targeted Tyrosine Kinase Inhibitors
Lapatinib • Tucatinib
Neratinib • AST-1306
CD47-Targeted
Evorpacept
Evorpacept has the Potential to be the 1st Approved IO Agent for HER2+ mBC
CD47 Expression Levels from RNA Sequencing1
Median TPM
As a "marker of self", CD47 is expressed on all cell types2
Cancer cells take advantage of this by overexpressing CD47
Bladder
Due to this, the vast majority of both solid and liquid tumors utilize CD47 to evade the immune system
In a meta-analysis of 38 cohorts across
17 publications including
>7,000 patients, "CD47 overexpression correlated with shorter OS in
cancer patients"*
Increased CD47 expression is correlated with poor patient outcomes in many tumor types including1:
Oral squamous cell carcinoma2
Nasopharyngeal carcinoma3
Triple negative breast cancer4
Ovarian cancer5
Non-small cell lung cancer6
Clear cell renal cell carcinoma7
Hepatocellular carcinoma8
Gastric adenocarcinoma9
Colorectal adenocarcinoma10
Head and neck squamous cell carcinoma11
Multiple myeloma12
*Yang et al, Translational Cancer Research, 2018; 1) Huang, et al, Scientific Reports, 2022; 2) Pai, et al, Cells, 2019; 3) Wang, et al, OncoTargets & Ther. 2020; 4) Yuan, et al, Oncol Lett, 2019; 5) Li, et al, Am J Trans Res, 2017; 6) Barrera, et al, Br J Cancer, 2017; 7) Jiang, et al, Urol Oncol, 2022; 8) Kim, et al, J Clin Pathol, 2021; 9) Shi, et al, Cancer Imm, Imm, 2021; 10) Kim, et al, Diagnostics, 2021;
CD47 Expression is Higher on
HER2+ BC Cells vs HER2- and…
… CD47-High Cells are More
Common in Recurrent HER2+ BC
CD47
20
No. of Patients
15
10
5
0
HER2+ HER2-
CD47
20
No. of Patients
15
10
5
0
Recurrent Primary
High
T-DXd (Enhertu) Exposure Increases CD47 Expression
CD47 MFI Gated on Live Cells
CD47 Expression
Flow cytometry assessment of surface CD47 expression on Au565 cells after 2 days of treatment with Enhertu's payload (DXd) or Kadcyla's payload (DM1) as compared to control (DMSO)
Per Tsao, Nature Communications, 2025 : "Interestingly, we found that DXd treatment raised surface CD47 levels in HER2 + BC cells."
Provides validation that CD47 is a key mode of Enhertu evasion and resistance in HER2+ breast cancer patients
ESMO Breast Cancer 202C - Abstract #72P
Funda Meric-Bernstam1, Kari B Wisinski2, Bruno Fang3, Kelly E McCann4, Sara Hurvitz5,
Kay T Yeung6, Ritesh Parajuli7, Jorge Chaves8, Adam Brufsky9, Peter A Kaufman10, Manish R Patel11, Timothy Pluard12, Sarah Meadows13, Emanuele Loro14, Kavita V Shah15, Alison Forgie16, Athanasios C Tsiatis17, Alberto J Montero18
1Department of Investigational Cancer Therapeutics, MD Anderson Cancer Center, University of Texas, Houston, TX, USA; 2Department of Medicine, University of Wisconsin, Madison, WI, USA; 3Medical Oncology and Hematology, Astera Cancer Center, East Brunswick, NJ, USA; 4Department of Medicine, Division of Hematology and Oncology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA; 5Fred Hutchinson Cancer Center, University of Washington School of Medicine, Seattle, WA, USA; 6Moores Cancer Center, University of California San Diego, La Jolla, CA, USA; 7Chao Comprehensive Cancer Center, University of California Irvine, Irvine, CA, USA; 8Phase 1 Clinical Research, Northwest Medical Specialties, Tacoma, WA, USA; 9University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, UPMC Magee-Womens Hospital, Pittsburgh, PA, USA; 10Division of Hematology and Oncology, University of Vermont Medical Center, Burlington, VT, USA; 11Drug Development, Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL, USA; 124Breast Cancer Oncology, Saint Luke's Cancer Institute, Kansas City, MO, USA; 13Biomarker Oncology Research, Jazz Pharmaceuticals, Palo Alto, CA, USA; 14Bioinformatics, Jazz Pharmaceuticals, Cambridge, UK; 15Clinical Development, Jazz Pharmaceuticals, Palo Alto, CA, USA; 16Translational Oncology, ALX Oncology Inc., South San Francisco, CA, US; 17Clinical Development, ALX Oncology Inc., South San Francisco, CA, US; 18University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH, USA
ALX Oncology
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ALX Oncology Holdings Inc. published this content on May 08, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 08, 2026 at 12:30 UTC.