Pyxis Oncology, Inc. · NASDAQ:PYXS
Pyxis Oncology — Corporate Update (March 2025)
29 slides from Pyxis Oncology's corporate update, Mar 18, 2025
Slide 1: Building a Differentiated ADC Company
Building a Differentiated ADC Company Nasdaq: PYXS March 18, 2025 Exhibit 99.2
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this pres
Slide 3: Positioned to be a Differentiated ADC Company
Positioned to be a Differentiated ADC Company *Balance sheet as of December 31, 2024 First-in-Concept Extra-cellular ADC Technology Deeply Experienced Team of Oncology Drug Developers Multiple Clinical Data Catalysts in 2025 Strong Balance Sheet* with $128M Cash Runway into 2H 2026
Slide 4: Aiming to Help the Difficult-to-Treat Head and Neck Squamous Cell Carcinoma Patient Populations
Aiming to Help the Difficult-to-Treat Head and Neck Squamous Cell Carcinoma Patient Populations Head and Neck Cancer is the sixth most common cancer in the world, with approximately 1.5 million new cases and nearly 488,000 deaths from HNC globally1 according to 2020 estimates. Overall incidence of H
Slide 5: The R/M HNSCC Treatment Landscape is Evolving with Unmet Needs Remaining
The R/M HNSCC Treatment Landscape is Evolving with Unmet Needs Remaining Current SOC lacks long term survival benefit Current innovation in development Current Stand of Care Anticipated changes in clinical practices KEYTRUDA® (anti-PD-1) +/- Chemo1 Erbitux (EGFRi) +/- Chemo1 40% 5-year survival for
Slide 6: Our novel ADC has a Differentiated Mechanism that Alters the Tumor Micro-Environment
Our novel ADC has a Differentiated Mechanism that Alters the Tumor Micro-Environment (TME) to Enhance the Opportunity for Tumor Killing Source: Hooper et al., 2022; Ashman, et al., Chem. Soc. Rev., 2022 Source: Ashman, et al., Chem. Soc. Rev., 2022,51 Micvotabart pelidotin (“MICVO” aka PYX-201) bind
Slide 7: Focused R/M HNSCC Clinical Pipeline Delivering Catalysts H25-1H26
Focused R/M HNSCC Clinical Pipeline Delivering 3 Catalysts 2H25-1H26 *MICVO was formerly PYX-201. **KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Advancing MICVO*, a differentiated extra-cellular ADC Program Planned Indication(s)
Slide 8: Leadership
Leadership Lara Sullivan, MD President and Chief Executive Officer Balu Balasubramanian, PhD Interim Chief Technology Officer Thuy Craveiro, PharmD Head of Clinical Pharmacology Marsha Crochiere, PhD Head of Translational Medicine Shui He, PhD Head Of Biometrics Pam Connealy, MBA Chief Financial Off
Slide 9: Key Focus Areas for MICVO
Key Focus Areas for MICVO Innovation Stability Tolerability Ph 1 Part 1 Preliminary Responses Development Approach 1 2 3 4 5 First-in-concept ADC targeting an overexpressed protein (EDB+FN) in the tumoral extra-cellular matrix where the high potency linker-payload is selectively cleaved Stable molec
Slide 10: MICVO is the First-in-Concept Extra-Cellular Targeting ADC in Clinical Development
MICVO is the First-in-Concept Extra-Cellular Targeting ADC in Clinical Development Note: CAFs- cancer-associated fibroblasts Targets EDB+FN, a novel non-cellular target Tumor Vasculature (e.g., Avastin) Fibronectin CAFs EDB+FN (MICVO) Immune Cells (e.g., KEYTRUDA®) Tumor Cells (e.g., Enhertu) MICVO
Slide 11: MICVO targets EDB+FN, a Novel Non-Cellular Target Overexpressed in Tumor Tissue
MICVO targets EDB+FN, a Novel Non-Cellular Target Overexpressed in Tumor Tissue Compared to Normal Tissue Source: Pyxis Oncology nonclinical data IHC assay demonstrates robust baseline EDB+FN in indications of interest EDB+FN expression from Phase 1 patient biopsies consistent with IHC validation da
Slide 12: Key potential advantages over traditional ADCs
Key potential advantages over traditional ADCs MICVO Construct ADC Construct with Site-Specific Conjugation Chemistry and Optimized Auristatin Payload Designed for Improved Stability and Biological Potency mAb uniquely directed at EDB+FN in the ECM Designed to reduce off-target effects Applicable to
Slide 13: Potential to Deliver Powerful Anti-Tumor Activity in Mono and Combo Regimens
Potential to Deliver Powerful Anti-Tumor Activity in Mono and Combo Regimens Non-cellular approach altering the ECM may potentially address a primary cause of drug resistance MICVO designed to bind to EDB and releases payload within tumor ECM CD8+ lymphocyte Dendritic cell MICVO Cleaved & active pay
Slide 14: PK Profile Demonstrates Superior MICVO Stability in Circulation
PK Profile Demonstrates Superior MICVO Stability in Circulation Compared to Approved Val-Cit-MMAE ADCs 1. Based on the corresponding FDA label, shown as ADC half-life MMAE: Monomethyl Auristatin E The site-specific conjugation for MICVO delivers two advantages: Lower levels of free payload in circul
Slide 15: Ph1 Dose Escalation Study with Solid Tumor Types Completed 4Q24
Ph1 Dose Escalation Study with 10 Solid Tumor Types Completed 4Q24 Patient eligibility criteria 10 tumor types Study objectives All comer solid tumor patients with no biomarker patient selection Male or non-pregnant, non-lactating female participants age ≥18 years Histologically or cytologically con
Slide 16: Ph1 Dose Escalation Study Identified Range of Potentially Effective Doses
Ph1 Dose Escalation Study Identified Range of Potentially Effective Doses 80 patients dosed across 18 global sites 3.6 - 5.4 mg/kg Q3W focus of Phase 1 Part 1 recruitment Study explored doses from 0.3 - 8 mg/kg Q3W Observed dose- dependent responses starting at 3.6 mg/kg 52% of patients recruited in
Slide 17: MICVO Demonstrated Strong RECIST 1.1 Confirmed Signal In HNSCC Patients
MICVO Demonstrated Strong RECIST 1.1 Confirmed Signal In HNSCC Patients in Phase 1 Dose Escalation Trial Identified Dose Range of 3.6 – 5.4 mg/kg Q3W (n=6) & 2 cPRs 1 cCR Confirmed by RECIST 1.1 100% DCR cORR 50%
Slide 18: Heavily Pretreated R/M HNSCC Patients Evaluated by RECIST 1.1
6 Heavily Pretreated R/M HNSCC Patients Evaluated by RECIST 1.1 + / - / UNK: HPV positive / negative / unknown *Confirmed Response by RECIST 1.1 #Confirmed Response by RECIST 1.1 after Oct 4, 2024 data cutoff (-47% tumor regression) Patients treated at 3.6 - 5.4 mg/kg Q3W in Phase 1 Dose Escalation
Slide 19: MICVO Phase 1 Part 1 RECIST 1.1 Responses by Tumor Histology Across All Dose Levels
MICVO Phase 1 Part 1 RECIST 1.1 Responses by Tumor Histology Across All Dose Levels Note: Efficacy population defined by dose received; dose level for patients who escalated or de-escalated = starting dose N=65; 3 patients dosed after 10/4/24 data cutoff and do not yet have scans; 12 patients of the
Slide 20: MICVO was Well-Tolerated with Low Discontinuation Rate in Phase 1 Part 1
TRAEs N 3 3 3 8 11 3 39 4 3 771 All TRAEs 1 (33%) 1 (33%) 3 (100%) 6 (75%) 9 (82%) 3 (100%) 36 (92%) 4 (100%) 3 (100%) 66 (86%) Grade 1/2 TRAEs 1 (33%) 1 (33%) 3 (100%) 4 (50%) 8 (73%) 2 (67%) 22 (56%) 1 (25%) 2 (67%) 44 (57%) Grade 3/4 TRAEs 0 0 0 2 (25%) 1 (9%) 1 (33%) 14 (36%) 3 (75%) 1 (33%) 22
Slide 21: Grade 3/4 TRAE Profile Supports Potential of MICVO in Early Line and Combination Settings
N 3 3 3 8 11 3 39 4 3 771 Auristatin-Payload-related Toxicity Cutaneous2 0 0 0 0 0 0 3 (8%) 0 0 3 (4%) Neuropathy 0 0 0 1 (13%) 0 0 0 1 (25%) 0 2 (3%) Neutropenia 0 0 0 0 0 0 3 (8%) 1 (25%) 1 (33%) 5 (6%) Ocular 0 0 0 0 0 0 0 0 0 0 Non-Payload-related Toxicity Anemia3 0 0 0 0 0 0 2 (5%) 2 (50%) 0 4
Slide 22: Our Clinical Development Plan Offers a Well-Timed and Differentiated Approach
Our Clinical Development Plan Offers a Well-Timed and Differentiated Approach to Address Treatment Gaps for R/M HNSCC Patients Across Multiples Lines Monotherapy Program (2/3L) Combination Program with anti-PD-1 (1/2L+) Future potential monotherapy pivotal trial will position MICVO for a differentia
Slide 23: MICVO Anticipated Upcoming Milestones
MICVO Anticipated Upcoming Milestones Trial Initiation Q125 Monotherapy: Phase 1 Part 2 R/M HNSCC Granted Fast Track Designation by FDA Combo Therapy with anti-PD-1: Phase 1 Dose Escalation and Phase 1 R/M HNSCC Mid-2025 Combo Therapy with anti-PD-1: Dose Selection 2H 2025 Monotherapy Preliminary Da
Slide 24: Positioned to be a Differentiated ADC Company
Positioned to be a Differentiated ADC Company *Balance sheet as of December 31, 2024 First-in-Concept Extra-cellular ADC Technology Deeply Experienced Team of Oncology Drug Developers Multiple Clinical Data Catalysts in 2025 Strong Balance Sheet* with $128M Cash Runway into 2H 2026
Slide 25: Appendix
Appendix
Slide 26: MICVO Dose Linear PK Demonstrates No Antigen Sink
MICVO Dose Linear PK Demonstrates No Antigen Sink (Q3W Dosing) Consistent with differentiated EDB+FN target expression in tumor ECM and negligible expression in normal tissue Nominal time after dose (d) Median plasma concentration (µg/mL) 0.3 mg/kg 0.6 mg/kg 1.2 mg/kg 2.4 mg/kg 3.6 mg/kg 5.4 mg/kg 6
Slide 27: MICVO Phase 1 Part 1 RECIST 1.1 Responses All Tumor Types Across All Dose Levels
Best % change from baseline PR CR PD PD PD PD PD PD PD PD PD PD PD SD SD SD SD SD PD PD PD SD PD SD SD PD PD SD SD SD SD SD PD PD SD SD SD SD SD PD PD SD SD SD SD PD SD SD SD SD SD SD SD SD SD PR SD PR #PR PR ##PR *PR PR PR *PR *PR *CR PR MICVO Phase 1 Part 1 RECIST 1.1 Responses All Tumor Types Acr
Slide 28: Phase 1 Part 1 Trial Patient Demographics Show Heavily Pretreated Heterogeneous Population
Phase 1 Part 1 Trial Patient Demographics Show Heavily Pretreated Heterogeneous Population 1. Safety evaluable population 2. Include Trodelvy, Enhertu, IMG-151(FRα ADC ), I-DXd, ELU001 (FRα ADC), ASN004 (5T4 ADC) HNSCC: head and neck squamous cell carcinomas NSCLC: Non-small cell lung cancer; PDAC:
Slide 29: Thank you
Building a Differentiated ADC Company Nasdaq: PYXS Thank you