Puma Biotechnology Inc · NASDAQ:PBYI
Puma Biotechnology — Investor Presentation (September 2023)
44 slides from Puma Biotechnology's investor presentation, September 2023
Slide 1: Puma Biotechnology Corporate Presentation
Puma Biotechnology Corporate Presentation September 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 N 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/ brai
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: $51.6 Million net NERLYNX revenue in Q2'23
$51.6 Million net NERLYNX revenue in Q2’23 ~0.6% growth compared to Q2’22 ~10% growth compared to Q1’23 Net Revenue (in $MM) Net Revenue (in $MM) 51.3 51.6 51.6 46.8 Q2'2022 Q2'2023 Q1'2023 Q2'2023 Inventory Change ($) Inventory Change ($) Q2’22 Q2’23 Q1’23 Q2’23 + $2.7 mil - $1.5 mil - $3.8 mil - $
Slide 6: 3,022 Ex-factory bottles were sold in Q2'23
3,022 Ex-factory bottles were sold in Q2’23 ~6% decline compared to Q2’22 ~6% growth compared to Q1’23 Bottles Bottles 3,200 3,022 3,022 2,849 Q2'2022 Q2'2023 Q1'2023 Q2'2023 Inventory Change Bottles Inventory Change Bottles Q2’22 Q2’23 Q1’23 Q2’23 179 -89 -236 -89 Includes commercial SP & SD bottle
Slide 7: ~70% of patients in Q2'23 started at a reduced dose
~70% of patients in Q2’23 started at a reduced dose* % of Patients starting at reduced dose 67.9% 69.5% 65.4% 64.0% 64.0% 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% 4.0% 2.0% 2.0% 3.0% *Reduced dose defined as fewer than 6 pills per day Copyright 2023 Pum
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: ALISERTIB
ALISERTIB Breast Cancer and Small-Cell Lung Cancer
Slide 11: 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 12: 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 13: 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 14: Clinical Development in Small-Cell Lung Cancer
Clinical Development in Small-Cell Lung Cancer
Slide 15: Phase 2 Study of Alisertib Monotherapy in Solid Tumors - 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 16: Phase 2 Alisertib Monotherapy - SCLC Response
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 17: Phase 2 Alisertib Monotherapy - SCLC Adverse Events
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 18: Randomized Phase 2 Paclitaxel plus Alisertib in Second-Line SCLC: 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 19: Randomized Phase 2 SCLC: c-Myc 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 20: Randomized Phase 2 SCLC: Cell Cycle Gene Alterations
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 21: 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 21
Slide 22: PUMA-ALI-4201 Phase II study design
PUMA-ALI-4201 Phase II study design Key inclusion criteria • Pathologically confirmed ES-SCLC • Progression on or after first-line platinum- based chemo; must have prior immunotherapy Alisertib • Measurable disease per RECIST v1.1 N = up to 60 50 mg po BID on days 1-7 of every 21-day • Must provide
Slide 23: Efficacy and safety objectives and endpoints
Efficacy and safety objectives and endpoints Objective Primary Endpoint • Proportion of patients with confirmed complete responses (CR) or partial responses (PR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Secondary Endpoints • Duration of response (DOR) • Di
Slide 24: Parallel Clinical and Biomarker Development
Parallel Clinical and Biomarker Development Comprehensive biomarker strategy supports clinical development and commercialization Drug Enrollment of ALI-4201 Data Amended ALI-4201 for biomarker Treatment development (up to 60 pts) Analysis defined population to support potential Accelerated Approval
Slide 25: Clinical Development of Alisertib in Breast Cancer
Clinical Development of Alisertib in Breast Cancer
Slide 26: 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 27: Phase 2 Alisertib Monotherapy - Breast Cancer Response
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 28: Phase 2 Alisertib Monotherapy - Breast Cancer Adverse Events
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 29: 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 30: Phase 2 Alisertib + Fulvestrant vs Alisertib Results
Phase 2 Randomized Trial of Alisertib + Fulvestrant vs Alisertib in Advanced HR+ Breast Cancer Haddad TC SABCS 2020 PD2-05 30
Slide 31: Phase 2 Paclitaxel + Alisertib vs Paclitaxel - ER+/HER2- MBC Efficacy
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 32: Paclitaxel + Alisertib Efficacy in Palbociclib-Pretreated Patients
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 33: 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 33
Slide 34: 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 35: Overview of Alisertib Clinical Development Plan in Breast Cancer
Overview of Alisertib Clinical Development Plan in Breast Cancer Target Patient Population(s) Rationale for Selected Indication Potential Biomarker-defined Subgroups HR+/HER2- metastatic breast • Prior Clinical Data • c-Myc amplification cancer (MBC) • Puma experience in breast • Rb1 deficiency canc
Slide 36: 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 37: 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 38: Intellectual Property on EGFR T790M Mutations
Intellectual Property on EGFR T790M Mutations Issued claims in Europe, Asia, Australia (expires 2026) – Possibility to extend up to 5 years Issued claims in United States (expires 2026) Patent claims upheld after European Opposition Hearing (February 2014) – Patent claims upheld after Appeal to Euro
Slide 39: Puma – Expected Milestones
Puma – Expected Milestones Initiate a Phase II clinical trial of alisertib in small cell lung cancer (H2 2023) Conduct a meeting with the FDA to discuss the clinical development and registration pathway for alisertib in hormone receptor-positive breast cancer (Q4 2023) Report data from an ongoing in
Slide 40: 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 41: 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 42: Puma Biotechnology – Financial
Puma Biotechnology – Financial Currently trading on NASDAQ: PBYI Cash, cash equivalents and marketable securities at June 30, 2023: $74 million Net income in Q2 2023: $2.1 million Cash earned in Q2 2023: $3.2 million Private placements: – March 2022: 3,584,228 shares issued to Alan Auerbach and Athy
Slide 43: 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 44: Puma Biotechnology
Puma Biotechnology Corporate Presentation September 2023
Puma Biotechnology — Investor Presentation (September 2023) on 6ix