Puma Biotechnology Inc · NASDAQ:PBYI
Puma Biotechnology — Investor Presentation (July 2026)
63 slides from Puma Biotechnology's investor presentation, July 2026
Slide 1: Puma Biotechnology Corporate Presentation
Puma Biotechnology Corporate Presentation July 2026
Slide 2: 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 3: Product Pipeline
Product Pipeline Phase I Phase II Phase III Registration Approval N Neratinib: Tyrosine kinase inhibitor HER2+ Breast Cancer ExteNET (Phase III HER2+ EBC*) Extended adjuvant Neratinib monotherapy CONTROL Metastatic NALA (Phase III 3rd Line HER2+ MBC**) Monotherapy or combo therapy Metastatic HER2 am
Slide 4: 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 5: $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 6: 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 7: ~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 7
Slide 8: 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 9: NERLYNX Extended Adjuvant HER2+ Breast Cancer Market Size
NERLYNX® Extended Adjuvant HER2+ Breast Cancer Market Size Approximately 28,300 patients (US) with early stage HER2+ breast cancer treated with adjuvant treatment1 Approximately 6,000 patients (US) with HR positive early stage HER2+ breast cancer and no pathological complete response to neoadjuvant
Slide 10: Puma Financial Guidance for Q2 and FY 2026
Puma Financial Guidance for Q2 and FY 2026 (updated) (prior) Q2 2026 Full Year 2026 Full Year 2026 NERLYNX revenue guidance: $50–$52 mil $202–$206 mil $194–$198 mil NERLYNX royalty guidance: $2–$3 mil $20–$23 mil $20–$23 mil Total Revenue $52–$55 mil $222–$229 mil $214–$221 mil Net income*: $2–$4 mi
Slide 11: NCI ETCTN trial 10495 – Phase I safety study of Neratinib+T-DXd
NCI ETCTN trial 10495 – Phase I safety study of Neratinib+T-DXd Rationale Dose escalation: 1. Neratinib enhances uptake of T-DXd. 2. Neratinib enhances the tumor Dose Level Neratinib T-DXd regression from T-DXd in HER2 mutant Level -1 120 mg PO, QD 5.4 mg/Kg, IV, q3 Week breast cancer PDX’s. Level 1
Slide 12: Interim Data Presented at AACR 2025
Interim Data Presented at AACR 2025 NSABP FB-7 Copyright 2026 Puma Biotechnology 12
Slide 13: Alisertib
ALISERTIB Breast Cancer and Small Cell Lung Cancer
Slide 14: Alisertib (MLN 8237) Aurora Kinase A (AURKA) inhibitor
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 15: 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 16: Clinical Development of Alisertib in Breast Cancer
Clinical Development of Alisertib in Breast Cancer
Slide 17: 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 18: ALISCA-Breast1 Summary of Prior Metastatic Anti-cancer Therapy
ALISCA®-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 (92.7
Slide 19: Alisertib Grades 3-4 TEAEs in Subjects with MBC
Alisertib Grades 3-4 TEAEs in Subjects with MBC ALISCA®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 (8.9)
Slide 20: ALISCA-Breast1 Summary of Clinical Benefit
ALISCA®-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 21: ALISCA-Breast1 PFS – ITT population
ALISCA®-Breast1 PFS – ITT population Progression Free Survival 21
Slide 22: ALISCA-Breast1 PFS MYC Copy Number
ALISCA®-Breast1 PFS MYC Copy Number 22
Slide 23: ALISCA-Breast1 PFS by c-Myc % Positive Cells by Treatment Group
ALISCA®-Breast1 PFS by c-Myc % Positive Cells by Treatment Group 50mg BID 40mg BID 23
Slide 24: ALISCA-Breast1 PFS by ESR1 Mutation Status – ctDNA
ALISCA®-Breast1 PFS by ESR1 Mutation Status by Treatment Group – ctDNA 50mg BID 40mg BID 24
Slide 25: ALISCA-Breast1 PFS by PIK3CA Mutation Status – ctDNA
ALISCA®-Breast1 PFS by PIK3CA Mutation Status by Treatment Group – ctDNA 50mg BID 40mg BID 25
Slide 26: ALISCA-Breast1 PFS PIK3CA Wild type by ESR1 Mutation Status
ALISCA®-Breast1 PFS Patients with PIK3CA Wild type by ESR1 Mutation Status by Treatment Group – ctDNA 50mg BID 40mg BID 26
Slide 27: ALISCA-Breast1 Patients with ESR1 mut and PIK3CA WT – FFPE Summary
ALISCA®-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 ce
Slide 28: Parallel Clinical and Biomarker Development
Parallel Clinical and Biomarker Development Comprehensive biomarker strategy supports clinical development and commercialization Drug Enrollment of ALISCA®- Data Amended ALISCA®-Breast1 for development Breast1 Treatment Analysis biomarker defined population to support potential Phase III trial b s B
Slide 29: ALISCA-Breast1 – Expected Milestones
ALISCA®-Breast1 – Expected Milestones Expand enrollment to obtain more data on biomarker directed cohorts (H2 2026) PIK3CA Wild Type ESR1 Mutant Additional interim data from ALISCA®-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of ER positive
Slide 30: Clinical Development in Small Cell Lung Cancer
Clinical Development in Small Cell Lung Cancer
Slide 31: ALISCA-Lung1 Study Design – Alisertib Monotherapy
ALISCA®-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 PD Follow-up PDL-1 immuno
Slide 32: ALISCA-Lung1 SCLC History and Baseline Characteristics
ALISCA®-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 (65
Slide 33: ALISCA-Lung1 Summary of Prior Anti-cancer Therapy
ALISCA®-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 34: ALISCA-Lung1 Incidence of Grade 3 or 4 TEAEs Compared to Study C14007
ALISCA®-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 (23
Slide 35: ALISCA-Lung1 Summary of Clinical Benefit
ALISCA®-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 36: ALISCA-Lung1 PFS – ITT Population by Treatment Group
ALISCA®-Lung1 PFS – ITT Population by Treatment Group Progression Free Survival 36
Slide 37: ALISCA-Lung1 PFS by c-Myc H-score by Treatment Group
ALISCA®-Lung1 PFS by c-Myc H-score by Treatment Group 50 mg BID 60 mg BID 37
Slide 38: ALISCA-Lung1 PFS by c-Myc % Positive Cells by Treatment Group
ALISCA®-Lung1 PFS by c-Myc % Positive Cells by Treatment Group 50 mg BID 60 mg BID 38
Slide 39: ALISCA-Lung1 – Expected Milestones
ALISCA®-Lung1 – Expected Milestones ✓ Initiate enrollment of 70 mg BID monotherapy cohort in ALISCA®-Lung1(H2 2026) Initiate enrollment of ALISCA® Lung2 – Phase I/II trial of alisertib in combination with paclitaxel (H2 26) Additional interim data from ALISCA®-Lung1, a Phase II clinical trial of ali
Slide 40: Intellectual Property for NERLYNX (neratinib)
Intellectual Property for NERLYNX (neratinib) Composition of matter patent issued (expires 2030) – Extended by USPTO in November 2021 per Hatch/Waxman Use in the treatment of cancer issued (expires 2025) Two polymorph patents issued (both expire 2028) Combination with capecitabine (expires 2031) Use
Slide 41: Intellectual Property for alisertib
Intellectual Property for alisertib Composition of matter patent issued (expires 2029) Use in the treatment of proliferative disorders (expires 2032) Use in the treatment of small cell lung cancer (expires 2033) Use in the treatment of breast cancer (expires 2034) Additional patents being filed and
Slide 42: Puma – Expected Milestones
Puma – Expected Milestones ✓ Report interim data from ALISCA®-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q2 2026) ✓ Additional interim data from ALISCA®-Lung1, a
Slide 43: Experienced Management Team
Experienced Management Team Alan H. Auerbach Chairman, Chief Executive Officer, President, Founder – Chief Executive Officer, President, Founder, Cougar Biotechnology Maximo F. Nougues Chief Financial Officer – Getinge AB, Boston Scientific, The Clorox Company Douglas Hunt Chief Scientific Officer (
Slide 44: Board of Directors
Board of Directors Alan H. Auerbach Chairman, Chief Executive Officer, President, Founder, Puma Biotechnology, Inc. Alessandra Cesano, MD, PhD Former Chief Medical Officer, ESSA Pharmaceuticals; NanoString; Cleave Biosciences; Nodality; Amgen; Biogen; SmithKline Allison Dorval CFO, AIRNA; CFO, Verve
Slide 45: Puma Biotechnology – Financial
Puma Biotechnology – Financial Currently trading on NASDAQ: PBYI Cash, cash equivalents and marketable securities at March 31, 2026: $101.5 million Net loss in Q1 2026: $3.8 million Cash earned in Q1 2026: $4 million Private placements: – March 2022: 3,584,228 shares issued to Alan Auerbach and Athy
Slide 46: Company Highlights
Company Highlights NERLYNX® – first HER2-directed drug approved by FDA for extended adjuvant treatment of early-stage HER2+ breast cancer in patients who have received prior trastuzumab NERLYNX® – first HER2-directed tyrosine kinase inhibitor approved in both early stage and metastatic HER2+ breast
Slide 47: Puma Biotechnology
Puma Biotechnology Corporate Presentation July 2026
Slide 48: Appendix
Puma Biotechnology Appendix July 2026
Slide 49: Phase II Study of Alisertib Monotherapy in Solid Tumors - Breast Cancer Cohorts
Phase II Study of Alisertib Monotherapy in Solid Tumors - Breast Cancer Cohorts Study design: • Pts had to have undergone ≤ 2 previous cytotoxic regimens, not including adjuvant or neoadjuvant treatments • Alisertib administered orally in 21-day cycles at 50 mg twice daily for 7 days followed by a b
Slide 50: Phase II Alisertib Monotherapy – Breast Cancer Response
Phase II Study of Alisertib Monotherapy in Solid Tumors - Breast Cancer Cohorts 9 / 49 patients (18%; 95% CI 9–32) had an objective response; all responders achieved a partial response Change in target lesion size and best response (investigator assessed response) PD=progressive disease. SD=stable d
Slide 51: Phase II Alisertib Monotherapy – Breast Cancer Adverse Events
Phase II Study of Alisertib Monotherapy in Solid Tumors - Breast Cancer Cohorts All-cause adverse events in safety evaluable breast cancer cohort (n=53) Table adapted from Melichar B Lancet Oncol 2015. Data are number of patients with AE (%) for AEs of any grade in at least 10% of patients overall.
Slide 52: Phase II Randomized Trial of Alisertib + Fulvestrant vs Alisertib
Phase II Randomized Trial of Alisertib + Fulvestrant vs Alisertib in Advanced HR+ Breast Cancer Patients (n=96 randomized) Regimen & Schedule Patients Inclusion (n=96) Criteria • Alisertib + Fulvestrant: Alisertib 50 mg PO • Post-menopausal women BID on days 1-3, 8-10, 15-17 q 28-day cycle • Histolo
Slide 53: Phase II Alisertib + Fulvestrant Safety
Phase II Randomized Trial of Alisertib + Fulvestrant vs Alisertib in Advanced HR+ Breast Cancer Safety Reason for Alisertib + Fulvestrant Treatment Alisertib (n=46)^ (n=45)^ Alisertib Alisertib + Fulvestrant Discontinuation (n=46) (n=45) Disease 38* 31 Gr3 Gr4 Gr3 Gr4 progression Hematologic Adverse
Slide 54: Paclitaxel + Alisertib vs Paclitaxel – Efficacy in ER+/HER2- MBC
Phase II Randomized Study of Paclitaxel + Alisertib vs Paclitaxel Alone - Efficacy in ER+/HER2- MBC Cohort PFS in ER+/HER2- ITT Study design: Median PFS: 10.2 (3.8-15.7) mo for • Patients with ER+/HER2- or triple negative metastatic paclitaxel + alisertib vs 7.1 (3.8-10.6) breast cancer stratified b
Slide 55: Paclitaxel + Alisertib – Cohort Pretreated with Palbociclib
Phase II Randomized Study of Paclitaxel + Alisertib vs Paclitaxel Alone - Efficacy in ER+/HER2- MBC Cohort Pretreated with Palbociclib Efficacy in patients pretreated with palbociclib (n=30) • Median PFS: 13.9 (5.6-15.6) mo (14 pts) w/ paclitaxel + alisertib vs 5.6 (3.0-10.6) mo (16 pts) w/ paclitax
Slide 56: Rb1 Loss and c-Myc Upregulation Correlate with Palbociclib Resistance
Rb1 Loss and c-Myc Upregulation Correlate with Palbociclib Resistance Both RB1 loss and MYC upregulation were observed in palbociclib-resistant HR+ breast cancer cell lines, supporting a role for alisertib in this setting RB1 Loss C-Myc Upregulation Pandey Cancers 2020 56
Slide 57: Phase II Alisertib Monotherapy in Solid Tumors - SCLC Cohorts
Phase II Study of Alisertib Monotherapy in Solid Tumors - SCLC Cohorts Study design: • Pts had to have undergone ≤ 2 previous cytotoxic regimens, not including adjuvant or neoadjuvant treatments • Alisertib administration: orally in 21-day cycles at 50 mg twice daily for 7 days followed by a break o
Slide 58: Phase II Alisertib Monotherapy – SCLC Response
Phase II Study of Alisertib Monotherapy in Solid Tumors - SCLC Cohorts 10 (21%; 95% CI 10–35) of 48 patients had an objective response; all responders achieved a partial response Change in target lesion size and best response (investigator assessed response) PD=progressive disease. SD=stable disease
Slide 59: Phase II Alisertib Monotherapy – SCLC Adverse Events
Phase II Study of Alisertib Monotherapy in Solid Tumors - SCLC Cohorts All-cause adverse events in safety evaluable SCLC cohort (n=60) Table adapted from Melichar B Lancet Oncol 2015. Data are number of patients with AE (%) for AEs of any grade in at least 10% of patients overall. NA = not applicabl
Slide 60: Randomized Phase II Paclitaxel plus Alisertib vs Placebo: Primary Analysis
Randomized Phase II Study of Paclitaxel plus Alisertib vs Paclitaxel plus Placebo as Second-Line SCLC: Primary Analysis Study design: • Patients with relapsed or refractory SCLC stratified by relapse type (sensitive vs resistant or refractory) • Randomized 1:1 to alisertib + paclitaxel or placebo +
Slide 61: Paclitaxel plus Alisertib in SCLC: Correlative Biomarker Analysis
Randomized Phase II Study of Paclitaxel plus Alisertib vs Paclitaxel plus Placebo as Second-Line SCLC: Correlative Biomarker Analysis Improved PFS observed among patients positive versus negative for c-Myc expression PFS in patients positive for c-Myc expression Median PFS 4.64 mo w/ paclitaxel + al
Slide 62: Paclitaxel plus Alisertib in SCLC: Cell Cycle Gene Alterations
Randomized Phase II Study of Paclitaxel plus Alisertib vs Paclitaxel plus Placebo as Second-Line SCLC: Correlative Biomarker Analysis Improved outcomes among pts with genetic alternations in cell cycle genes CDK6, RBL1, RBL2, and RB1 (collectively referred to as “mutant”) Owonikoko J Thorac Oncol 20
Slide 63: Paclitaxel plus Alisertib in SCLC: Safety
Randomized Phase II Study of Paclitaxel plus Alisertib vs Paclitaxel plus Placebo as Second-Line SCLC: Safety AE, adverse event Owonikoko J Thorac Oncol 2020 63
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