Puma Biotechnology Inc · NASDAQ:PBYI
Puma Biotechnology — B. Riley Securities' 3rd Annual Oncology Conference 2023
49 slides from Puma Biotechnology's conference presentation, January 2023
Slide 1: Puma Biotechnology
Puma Biotechnology B. Riley Securities’ 3rd Annual Oncology Conference January 2023
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 Neratinib: Tyrosine kinase inhibitor HER2+ Breast Cancer ExteNET (Phase III HER2+ EBC*) Extended adjuvant Neratinib monotherapy CONTROL Metastatic Monotherapy or combo therapy NALA (Phase III 3rd Line HER2+ MBC**) Metastatic w/ brain
Slide 4: PUMA's Pharmacy and Distributor Network
PUMA’s Pharmacy and Distributor Network Hub Services Specialty Pharmacy Network (SP) Acaria Health Accredo CVS ONCO 360 Patients Optum / Biologics Diplomat Sites of Care Specialty Distributor Network (SD) Academic Hospitals McKesson Community Hospitals ASD/Oncology Supply Physician Practices Cardina
Slide 5: ~$54 Million net NERLYNX revenue in Q3'22
~$54 Million net NERLYNX revenue in Q3’22 Quarterly Net Revenue (in $MM) 61.1 58.7 53.8 53.5 54.3 52.6 51.3 50.8 50.0 51.0 48.6 48.8 49.3 48.9 45.6 45.8 43.4 40.7 36.0 20.1 6.1 Copyright 2023 Puma Biotechnology 5
Slide 6: 3,323 Ex-factory bottles were sold in Q4'22
3,323 Ex-factory bottles were sold in Q4’22* Bottles Sold (SP + SD) by Quarter 5,538 4,936 4,935 4,799 4,791 4,696 4,452 4,035 3,728 3,611 3,517 3,585 3,454 3,247 3,354 3,200 3,197 3,323 2,947 2,680 2,137 675 Includes Commercial SP and SD *Q4’22 Ex-factory is preliminary estimate and not yet final.
Slide 7: ~68% of patients in Q3'22 started at a reduced dose
~68% of patients in Q3’22 started at a reduced dose* ** % of Patients starting at reduced dose 67.9% 65.4% 61.5% 59.4% 54.9% 42.4% 37.7% 38.7% 32.8% 30.0% 31.0% 28.0% 19.0% 12.0% 11.0% 6.0% 7.0% 3.0% 4.0% 2.0% 2.0% *Reduced dose defined as fewer than 6 pills per day ** FDA approved dose-escalation l
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 – Singapore • 2020 – Ext. Adj. in Brunei, Malaysia, New Zealand Australia / SE Asia • Q2 2021 – Malaysia • Q2 2022 – Ext. Adj. in the Philippines • Q3 / Q4
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: TBCRC 022: Phase II Trial of Neratinib in HER2+ Breast Cancer with Brain Metastases
TBCRC 022: Phase II Trial of HKI-272 (Neratinib) for Patients with HER2+ Breast Cancer and Brain Metastases Progressive Cohort 1 (n = 40 pts) (Treat until PD or toxicity; if non-CNS PD, Neratinib (240 mg/day) brain mets trastuzumab may be added) Craniotomy candidates Cohort 2 (n = 5 pts) Neratinib (
Slide 11: TBCRC-022 Cohort 3a CNS Response
TBCRC-022 Cohort 3a CNS Response Best Volumetric Response (n=31)* Best Volumetric CNS response (n=31 evaluable pts) 100 % reduction in volume of CNS lesions 80 CNS ORR = 49% (95% CI 32–66%) 60 40 20 0 -20 -40 -60 -80 18 responses -100 Copyright 2023 Puma Biotechnology * ASCO 2017 11
Slide 12: TBCRC-022 Cohort 4 CNS Response
TBCRC-022 Cohort 4 CNS Response* Cohort 4A Cohort 4B Cohort 4C Copyright 2023 Puma Biotechnology * SABCS 2022 12
Slide 13: Neratinib Included as Treatment Option for CNS Metastases by NCCN
Neratinib Included as a Treatment Option for Recurrent Breast Cancer CNS Metastases By NCCN® Guidelines1 Guidelines updated March 2020 Category 2A: Category 2B: Neratinib + Capecitabine Neratinib + Paclitaxel TBCRC 0222 NEfERT-T3,4 A Phase II Trial of Neratinib and Randomized, Multi-Center, Internat
Slide 14: Current SUMMIT 'Basket' Trial: Study Design
Current SUMMIT ‘Basket’ Trial: Study Design EGFR exon18- Neratinib EGFR, HER2 or HER4 mutations mutant tumors Lung monotherapy (documented by local testing) Cervical Primary endpoint • Objective response rate at first post-baseline tumor assessment (ORRfirst) Neratinib Salivary gland Secondary endpo
Slide 15: SUMMIT Breast Cancer Cohort
SUMMIT Breast Cancer Cohort
Slide 16: Change in tumor size (target lesion) and characteristics
Change in tumor size (target lesion) and characteristics* Non-randomized Randomized Randomized Randomized HR+ HR+ HR+ HR+ Prior CDK4/6i Prior CDK4/6i Prior CDK4/6i Prior CDK4/6i TNBC N+F+T N+F+T F+T F N+T Best overall response CR PR SD 100 HER2 mutation category PD Kinase domain hotspot Kinase domai
Slide 17: SUMMIT Basket Trial: EGFR exon lung cancer cohort update
SUMMIT (PUMA-NER-5201) Basket Trial EGFR exon 18 lung cancer cohort update
Slide 18: EGFR Exon 18-Mutant Lung Cancer Cohort Receiving Neratinib Monotherapy
EGFR Exon 18-Mutant Lung Cancer Cohort Receiving Neratinib Monotherapy: Treatment Duration, Best Response and Best Change in Tumor* Data cutoff date: Sep 2022 Copyright 2023 Puma Biotechnology * 2022 EORTC/NCI/AACR Symposium 18
Slide 19: Alisertib: Breast Cancer and Small-Cell Lung Cancer
ALISERTIB Breast Cancer and Small-Cell Lung Cancer
Slide 20: Alisertib (MLN 8237) Aurora Kinase A 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 21: Synthetic Lethality of AURKA and Rb1
Synthetic Lethality of AURKA and Rb1 Cancers with a hypersensitive spindle assembly checkpoint (SAC) depend on AURKA for mitotic exit and survival1 • Loss of function of Rb1 is a common event in cancer and can emerge as a mechanism of resistance to EGFR, CDK4, and ER-targeted therapies in breast and
Slide 22: 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 23: Clinical Experience in Small-Cell Lung Cancer
Clinical Experience in Small-Cell Lung Cancer
Slide 24: Phase 2 Study of Alisertib Monotherapy - SCLC Cohorts
Phase 2 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 of
Slide 25: Phase 2 Study of Alisertib Monotherapy - SCLC Cohorts
Phase 2 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 26: Phase 2 Study of Alisertib Monotherapy - SCLC Cohorts
Phase 2 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 applicable
Slide 27: Grade 3-4 AEs Present in ≥10% of SCLC Patients
Grade 3-4 AEs Present in ≥ 10% of SCLC Patients - alisertib monotherapy compared to lurbinectedin monotherapy Alisertib (n=60)1 Lurbinectedin (n=105)2 AE All grade, n (%) Grade 3-4, n (%) All grade, n (%) Grade 3-4, n (%) Neutropenia 27 (45%) 22 (37%) 75 (71%) 48 (46%) Anemia 19 (32%) 10 (17%) 100 (
Slide 28: Randomized Phase 2 Paclitaxel plus Alisertib vs Placebo: Primary Analysis
Randomized Phase 2 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 + p
Slide 29: Randomized Phase 2 SCLC: Correlative Biomarker Analysis
Randomized Phase 2 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 + ali
Slide 30: Randomized Phase 2 SCLC: Correlative Biomarker Analysis
Randomized Phase 2 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 202
Slide 31: Randomized Phase 2 SCLC: Safety
Randomized Phase 2 Study of Paclitaxel plus Alisertib vs Paclitaxel plus Placebo as Second-Line SCLC: Safety AE, adverse event Owonikoko J Thorac Oncol 2020 31
Slide 32: Clinical Studies of Alisertib in Breast Cancer
Clinical Studies of Alisertib in Breast Cancer
Slide 33: Phase 2 Alisertib Monotherapy - Breast Cancer Cohorts
Phase 2 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 br
Slide 34: Phase 2 Alisertib Monotherapy - Breast Cancer Cohorts
Phase 2 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 di
Slide 35: Phase 2 Alisertib Monotherapy - Breast Cancer Cohorts
Phase 2 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. N
Slide 36: Phase 2 Alisertib + Fulvestrant vs Alisertib in HR+ Breast Cancer
Phase 2 Randomized Trial of Alisertib + Fulvestrant vs Alisertib in Advanced HR+ Breast Cancer Patients (n=96) 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 • Histologically-prov
Slide 37: Phase 2 Alisertib + Fulvestrant vs Alisertib in HR+ Breast Cancer
Phase 2 Randomized Trial of Alisertib + Fulvestrant vs Alisertib in Advanced HR+ Breast Cancer Haddad TC SABCS 2020 PD2-05 37
Slide 38: Phase 2 Paclitaxel + Alisertib vs Paclitaxel - ER+/HER2- MBC
Phase 2 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 by
Slide 39: Efficacy in ER+/HER2- MBC Cohort Pretreated with Palbociclib
Phase 2 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/ paclitaxe
Slide 40: 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 40
Slide 41: Summary of Alisertib Efficacy in Metastatic Breast Cancer
Summary of Alisertib Efficacy in Metastatic Breast Cancer Tumor Type Active Regimen Comparator Reference Regimen (N) N Median PFS Regimen (N) N Median PFS (mo, 95% CI) (mo, 95% CI) HR+/HER2- alisertib 50 mg BID1 26 7.9 (4.2-12.2) NA NA Melichar B Lancet Oncol 2015 ER+/HER2- alisertib 50 mg BID2 45 5
Slide 42: Study-related Neutropenia in Metastatic Breast Cancer
Study-related Neutropenia in Metastatic Breast Cancer - Alisertib compared to other agents Regimen All-grade Neutropenia (%) Grade 3/4 Neutropenia (%) Febrile Neutropenia (%) Alisertib monotherapy 50 mg BID1 63%1 57%1 4%1 Alisertib monotherapy 50 mg BID2 Not reported2 42%2 Not reported2 Alisertib 50
Slide 43: Overview of Alisertib Clinical Development Plan
Overview of Alisertib Clinical Development Plan Target Patient Population(s) Rationale for Selected Indication Potential Biomarker-defined Subgroups HR+/HER2- metastatic breast • Prior Clinical Data cancer (MBC) • Puma experience in breast cancer • c-Myc amplification Small Cell Lung Cancer • Prior
Slide 44: Puma – Expected Milestones
Puma – Expected Milestones Publication of the biomarker studies from the randomized trial of alisertib plus fulvestrant versus alisertib alone in hormone receptor-positive, HER2-negative breast cancer (H1 2023) Biomarker data from the randomized trial of alisertib plus paclitaxel versus paclitaxel a
Slide 45: Experienced Management Team
Experienced Management Team Alan H. Auerbach Chairman, Chief Executive Officer, President, Founder – Chief Executive Officer, President, Founder, Cougar Biotechnology Jeff Ludwig Chief Commercial Officer – Eli Lilly, Astellas, Amgen Maximo F. Nougues Chief Financial Officer – Getinge AB, Boston Scie
Slide 46: Board of Directors
Board of Directors Alan H. Auerbach Chairman, Chief Executive Officer, President, Founder, Puma Biotechnology, Inc. Alessandra Cesano, MD, PhD Chief Medical Officer, ESSA Pharmaceuticals; NanoString; Cleave Biosciences; Nodality; Amgen; Biogen; SmithKline Allison Dorval CFO, Verve Therapeutics; Form
Slide 47: Puma Biotechnology – Financial
Puma Biotechnology – Financial Currently trading on NASDAQ: PBYI Cash, cash equivalents and marketable securities at September 30, 2022: $78 million Net loss in Q3 2022: $0.4 million Cash earned in Q3 2022: $17.4 million Private placements: – March 2022: 3,584,228 shares issued to Alan Auerbach and
Slide 48: 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 49: Puma Biotechnology
Puma Biotechnology B. Riley Securities 3rd Annual Oncology Conference January 2023
Puma Biotechnology — B. Riley Securities' 3rd Annual Oncology Conference 2023 on 6ix