Puma Biotechnology Inc · NASDAQ:PBYI
Puma Biotechnology — Q1 2026 Earnings Presentation
53 slides from Puma Biotechnology's earnings presentation, May 7, 2026
Slide 1: Puma Biotechnology First Quarter 2026 Earnings Call
Puma Biotechnology First Quarter 2026 Earnings Call May 7, 2026
Slide 2: ALISCA-Lung1 (PUMA-ALI-4201) Interim Analysis
ALISCATM-Lung1 (PUMA-ALI-4201) Interim Analysis May 7, 2026 2
Slide 3: Alisertib (MLN 8237)
Alisertib (MLN 8237) Orally Bioavailable Aurora Kinase A Drug Class: Benzazepine (AURKA) inhibitor • Single-agent and combinational clinical activity in solid tumors including hormone receptor-positive breast cancer (HR+ MBC), triple negative breast cancer (TNBC), small cell lung cancer (SCLC), and
Slide 4: AURKA and c-Myc Co-regulate Each Other
AURKA and c-Myc Co-regulate Each Other Nuclear AURKA exerts kinase-independent functions by acting as a transcription factor AURKA c-Myc Genomic instability & • AURKA and c-Myc transcriptionally upregulate each other, tumor development suggesting the existence of a positive feedback loop E2F1 cyclin
Slide 5: ALISCA-Lung1 Study Design – Alisertib Monotherapy
ALISCATM-Lung1 (PUMA-ALI-4201) Study Design – Alisertib Monotherapy N = ~55 N = ~35 Original: SCLC Alisertib 50 mg BID N = tbd Long-term following on or after treatment with one* platinum-based chemotherapy + anti- on days 1-7 of every 21-day Amendment 2: Alisertib 60 mg BID Potential PD Follow-up P
Slide 6: ALISCA-Lung1 SCLC History and Baseline Characteristics
ALISCATM-Lung1 SCLC History and Baseline Characteristics 50 mg BID 60 mg BID Total (N=52) (N=27) (N=79) VALSG stage at initial diagnosis - n (%) Limited 7 (13.5) 6 (22.2) 13 (16.5) Extensive 45 (86.5) 20 (74.1) 65 (82.3) ECOG performance status at C1D1 – n (%) 0 16 (30.8) 10 (37.0) 26 (32.9) 1 34 (6
Slide 7: ALISCA-Lung1 Summary of Prior Anti-cancer Therapy
ALISCATM-Lung1 Summary of Prior Anti-cancer Therapy 50 mg BID 60 mg BID Total Prior anti-cancer therapy (N=52) (N=27) (N=79) Prior radiotherapy – n (%) No 16 (30.8) 12 (44.4) 28 (35.4) Yes 36 (69.2) 15 (55.6) 51 (64.6) Prior cancer-related surgery – n (%) No 44 (84.6) 25 (92.6) 69 (87.3) Yes 8 (15.4
Slide 8: Safety
Safety
Slide 9: ALISCA-Lung1 Incidence of TEAEs – All Grades
ALISCATM-Lung1 Incidence of TEAEs – All Grades 50 mg BID 60 mg BID Total (N=52) (N=27) (N=79) Subjects with at Least 1 Reported AE - n (%) 21 (40.4) 19 (70.4) 40 (50.6) Neutropenia 10 (19.2) 6 (22.2) 16 (20.3) Febrile neutropenia 2 (3.8) 2 (7.4) 4 (5.1) Thrombocytopenia 4 (7.7) 4 (14.8) 8 (10.1) Ane
Slide 10: ALISCA-Lung1 Incidence of Grade 3 or 4 TEAEs
ALISCATM-Lung1 Incidence of Grade 3 or 4 TEAEs 50 mg BID 60 mg BID Total (N=52) (N=27) (N=79) Subjects with at least one reported AE - n (%) 12 (23.1) 7 (25.9) 19 (24.1) Neutropenia 7 (13.5) 3 (11.1) 10 (12.7) Febrile neutropenia 2 (3.8) 2 (7.4) 4 (5.1) Thrombocytopenia 2 (3.8) 1 (3.7) 3 (3.8) Anemi
Slide 11: ALISCA-Lung1 Incidence of Grade 3 or 4 TEAEs Compared to Study C14007
ALISCATM-Lung1 Incidence of Grade 3 or 4 TEAEs Compared to Study C14007 C14007 PUMA-ALI-4201 PUMA-ALI-4201 Alisertib monotherapy Alisertib monotherapy Alisertib monotherapy 50 mg BID 7D 50 mg BID 7D 60 mg BID 7D (n=60)1 (n=52)2 (n=27)2 Subjects with at least one reported AESI - n (%) 28 (46.7) 12 (2
Slide 12: Efficacy
Efficacy
Slide 13: ALISCA-Lung1 Summary of Clinical Benefit
ALISCATM-Lung1 Summary of Clinical Benefit (Subjects with at Least One Post-baseline Scan or Ended Treatment Prior to First Scan) 50 mg BID 60 mg BID Response, n (%) (N=52) (N=15) Best overall response Complete response (CR) 0 0 Partial response (PR) 6 (11.5) 1 (6.7) Stable disease (SD) 18 (34.6) 7
Slide 14: ALISCA-Lung1 PFS – ITT Population by Treatment Group
ALISCATM-Lung1 PFS – ITT Population by Treatment Group Progression Free Survival 14
Slide 15: Biomarkers
Biomarkers
Slide 16: ALISCA-Lung1 PFS by c-Myc H-score
ALISCATM-Lung1 PFS by c-Myc H-score Total 16
Slide 17: ALISCA-Lung1 PFS by c-Myc H-score by Treatment Group
ALISCATM-Lung1 PFS by c-Myc H-score by Treatment Group 50 mg BID 60 mg BID 17
Slide 18: ALISCA-Lung1 PFS by c-Myc % Positive Cells
ALISCATM-Lung1 PFS by c-Myc % Positive Cells 18
Slide 19: ALISCA-Lung1 PFS by c-Myc % Positive Cells by Treatment Group
ALISCATM-Lung1 PFS by c-Myc % Positive Cells by Treatment Group 50 mg BID 60 mg BID 19
Slide 20: ALISCA-Lung1 – Expected Milestones
ALISCATM-Lung1 – Expected Milestones Initiate enrollment of 70 mg BID monotherapy cohort in ALISCATM-Lung1(H2 2026) Initiate enrollment of ALISCATM Lung2 – Phase I/II trial of alisertib in combination with paclitaxel (H2 26) Additional interim data from ALISCATM-Lung1, a Phase II clinical trial of a
Slide 21: ALISCA-Breast1 (PUMA-ALI-1201) Interim Analysis
ALISCATM-Breast1 (PUMA-ALI-1201) Interim Analysis May 7, 2026 21
Slide 22: Alisertib (MLN 8237)
Alisertib (MLN 8237) Orally Bioavailable Aurora Kinase A Drug Class: Benzazepine (AURKA) inhibitor • Single-agent and combinational clinical activity in solid tumors including hormone receptor-positive breast cancer (HR+ MBC), triple negative breast cancer (TNBC), small cell lung cancer (SCLC), and
Slide 23: AURKA and c-Myc Co-regulate Each Other
AURKA and c-Myc Co-regulate Each Other Nuclear AURKA exerts kinase-independent functions by acting as a transcription factor AURKA c-Myc Genomic instability & • AURKA and c-Myc transcriptionally upregulate each other, tumor development suggesting the existence of a positive feedback loop E2F1 cyclin
Slide 24: ALISCA-Breast1 Phase II Study Design
ALISCA -Breast1 Phase II dose optimization, biomarker evaluation in HR+/HER- MBC Key inclusion criteria: Arm 1 Alisertib 50 mg BID on Days 1-3, 8-10, • HR+/HER2- mBC patients who have Stratification 15-17 of a 28-day cycle + Endocrine 1:1:1 RANDOMIZATION factors received at least 2 prior lines of en
Slide 25: ALISCA-Breast1 Summary of Prior Metastatic Anti-cancer Therapy
ALISCATM-Breast1 Summary of Prior Metastatic Anti-cancer Therapy 50 mg BID 40 mg BID 30 mg BID Total (N=54) (N=55) (N=55) (N=164) Subjects with metastatic anti-cancer medication – n 50 (92.6) 51 (92.7) 51 (92.7) 152 (92.7) (%) Prior metastatic endocrine – n (%) 50 (92.6) 51 (92.7) 51 (92.7) 152 (92.
Slide 26: Safety
Safety
Slide 27: Alisertib Grades 3-4 TEAEs in Subjects with MBC
Alisertib Grades 3-4 TEAEs in Subjects with MBC ALISCATM-Breast1 TBCRC041 Alisertib + endocrine Alisertib + Alisertib Fulvestrant 50 mg BID 40 mg BID 30 mg BID 50 mg BID 50 mg BID (n=52)2 (n=49)2 (n=50)2 (n=46)1 (n=45)1 Neutropenia 19 (41.3) 19 (42.2) 14 (26.9) 5 (10.2) 4 (8.0) Anemia 8 (17.4) 4 (8.
Slide 28: Efficacy
Efficacy
Slide 29: ALISCA-Breast1 Summary of Clinical Benefit
ALISCATM-Breast1 Summary of Clinical Benefit1 50 mg BID 40 mg BID 30 mg BID (N=38) (N=40) (N=40) Best overall responsea - n (%) Complete response (CR) 0 0 0 Partial response (PR) 7 (18.4) 8 (20.0) 2 (5.0) Stable disease (SD) 16 (42.1) 22 (55.0) 15 (37.5) Non-CR/Non-PD 0 1 (2.5) 0 Disease progression
Slide 30: ALISCA-Breast1 PFS – ITT Population
ALISCATM-Breast1 PFS – ITT population Progression Free Survival 30
Slide 31: Biomarker
Biomarker
Slide 32: ALISCA-Breast1 PFS MYC Copy Number
ALISCATM-Breast1 PFS MYC Copy Number 32
Slide 33: ALISCA-Breast1 PFS by c-Myc % Positive Cells
ALISCATM-Breast1 PFS by c-Myc % Positive Cells 33
Slide 34: ALISCA-Breast1 PFS by c-Myc % Positive Cells by Treatment Group
ALISCATM-Breast1 PFS by c-Myc % Positive Cells by Treatment Group 50mg BID 40mg BID 34
Slide 35: ALISCA-Breast1 PFS ESR1 Mutation Status
ALISCATM-Breast1 PFS ESR1 Mutation Status ctDNA tissue 35
Slide 36: ALISCA-Breast1 PFS by ESR1 Mutation Status by Treatment Group – ctDNA
ALISCATM-Breast1 PFS by ESR1 Mutation Status by Treatment Group – ctDNA 50mg BID 40mg BID 36
Slide 37: ALISCA-Breast1 PFS by ESR1 Mutation Status by Treatment Group – Tissue
ALISCATM-Breast1 PFS by ESR1 Mutation Status by Treatment Group – Tissue 50mg BID 40mg BID 37
Slide 38: ALISCA-Breast1 PFS PIK3CA Mutation Status
ALISCATM-Breast1 PFS PIK3CA Mutation Status ctDNA tissue 38
Slide 39: ALISCA-Breast1 PFS by PIK3CA Mutation Status by Treatment Group – ctDNA
ALISCATM-Breast1 PFS by PIK3CA Mutation Status by Treatment Group – ctDNA 50mg BID 40mg BID 39
Slide 40: ALISCA-Breast1 PFS Patients with PIK3CA Wild type by ESR1 Mutation Status
ALISCATM-Breast1 PFS Patients with PIK3CA Wild type by ESR1 Mutation Status ctDNA Tissue 40
Slide 41: PIK3CA Wild type by ESR1 Mutation Status by Treatment Group – ctDNA
ALISCATM-Breast1 PFS Patients with PIK3CA Wild type by ESR1 Mutation Status by Treatment Group – ctDNA 50mg BID 40mg BID 41
Slide 42: PIK3CA Wild type by ESR1 Mutation Status by Treatment Group – Tissue
ALISCATM-Breast1 PFS Patients with PIK3CA Wild type by ESR1 Mutation Status by Treatment Group – Tissue 50mg BID 40mg BID 42
Slide 43: ALISCA-Breast1 Patients with ESR1 mut and PIK3CA WT
ALISCATM-Breast1 Patients with ESR1 mut and PIK3CA WT – Summary of FFPE tissue sample category and c-Myc positive cells Tissue DNA ctDNA PIK3CA Wild PIK3CA Wild PIK3CA Wild ESR1 Mutant and ESR1 PIK3CA Wild ESR1 Mutant and ESR1 (N=42) (N=24) Mutant (N=76) (N=59) Mutant (N=17) (N=28) c-Myc %positive c
Slide 44: Parallel Clinical and Biomarker Development
Parallel Clinical and Biomarker Development Comprehensive biomarker strategy supports clinical development and commercialization Drug Enrollment of ALISCATM- Data Amended ALISCATM-Breast1 for development Breast1 Treatment Analysis biomarker defined population to support potential Phase III trial b s
Slide 45: ALISCA-Breast1 – Expected Milestones
ALISCATM-Breast1 – Expected Milestones Expand enrollment to obtain more data on biomarker directed cohorts (H2 2026) PIK3CA Wild Type ESR1 Mutant Additional interim data from ALISCATM-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of ER positi
Slide 46: Puma Biotechnology Earnings Call Commercial Update
Puma Biotechnology Earnings Call Commercial Update May 7, 2026
Slide 47: Forward-Looking Safe-Harbor Statement
Forward-Looking Safe-Harbor Statement This presentation contains forward-looking statements, including statements regarding commercialization of NERLYNX® and the potential indications and development of our drug candidates. All forward-looking statements involve risks and uncertainties that could ca
Slide 48: Puma's Pharmacy and Distributor Network
Puma’s Pharmacy and Distributor Network Hub Services Specialty Pharmacy Network (SP) Acaria Health Accredo CVS ONCO360 Patients Optum / Biologics Diplomat Specialty Distributor Network (SD) Sites of Care McKesson Academic Hospitals ASD / Oncology Supply Community Hospitals Cardinal Health Physician
Slide 49: $42.0 Million Net NERLYNX Revenue in Q1'26
$42.0 Million Net NERLYNX Revenue in Q1’26 ~3% decrease in Q1’26 compared to Q1’25 ~30% decrease in Q1’26 compared to Q4’25 Net Revenue (in $MM) Net Revenue (in $MM) 59.9 43.1 42.0 42.0 Q1'25 Q1'26 Q4'25 Q1'26 Inventory Change ($) Inventory Change ($) Q1’25 Q1’26 Q4’25 Q1’26 -$4.7 mil -$7.9 mil $5.7
Slide 50: 2,328 Ex-Factory Bottles Were Sold in Q1'26
2,328 Ex-Factory Bottles Were Sold in Q1’26 ~0.4% decrease in Q1’26 compared to Q1’25 ~29% decrease in Q1’26 compared to Q4’25 Bottles Bottles 3,298 2,338 2,328 2,328 Q1'25 Q1'26 Q4'25 Q1'26 Inventory Change Bottles Inventory Change Bottles Q1’25 Q1’26 Q4’25 Q1’26 -251 -439 343 -439 Copyright 2026 P
Slide 51: ~78% of Patients in Q1'26 Started at a Reduced Dose
~78% of Patients in Q1’26 Started at a Reduced Dose* % of Patients Starting at Reduced Dose 76% 77% 78% 74% 75% 72% 71% 68% 70% 71% 65% 67% 66% 64% 64% 65% 62% 59% 55% 42% 38% 36% 33% 30% 31% 28% 19% 12% 11% *Reduced dose defined as fewer than 6 pills per day Copyright 2026 Puma Biotechnology 51
Slide 52: Rest of World Partnerships – Timelines
Rest of World Partnerships – Timelines Region Partner Regulatory Approvals Commercial Launches • 2019 – Ext. Adj. in Australia, Singapore • 2020 – Ext. Adj. in Brunei, Malaysia, New Zealand • 2020 – Singapore Australia / SE Asia • 2022 – Ext. Adj. in the Philippines; mBC in Singapore • 2021 – Malays
Slide 53: Puma Biotechnology Earnings Call Commercial Update
Puma Biotechnology Earnings Call Commercial Update May 7, 2026