Puma Biotechnology Inc · NASDAQ:PBYI
Puma Biotechnology — B. Riley Securities 4th Annual Oncology Conference (January 2024)
45 slides from Puma Biotechnology's conference presentation, Jan 18, 2024
Slide 1: Puma Biotechnology
Puma Biotechnology B. Riley Securities 4** Annual Oncology Conference January 2024
Slide 2: Forward-Looking Safe-Harbor Statement
Forward-Looking Safe-Harbor Statement Tis presentation contains forward-looking statements, including statements regarding commerciaizaton of NERLYNX® and the potential indications and development of our drug candidates. ll fonvar-looking statements involve risks and uncertaites that could cause our
Slide 3: Product Pipeline
Product Pipeline Neratinib: Tyrosine kinase inhibitor | ‘Monotherapy or combo therapy Alisertib: Aurorakinase A inhibitor HRc+** HER2-negative MBC Triple-negativeMBC. Small cell lung cancer Phase! Phaselll ExteNET (Phase Ill HER2+ EBC*) NALA (Phasellll 3° Line HER2: HER2+ BreastCancer Extended adjuv
Slide 4: Specialty and Distributor Network
icy and Distributor Network _ Hub Services Spociay Pharmacy Network (SP) PumaPatientl y nis Acaria Heath | Accredo wy | evs | oncosso @® Patients poor Biologics Sites of Care aed nsoercon seo | _* | ares Spocalty Distributor Network (SO) McKesson Cardinal Health Others (VA, DOD) DMS Pharmaceutical G
Slide 5: Net NERLYNX Revenue in Q3'23
Net NERLYNX Revenue in Q3’23 ~5% decline comparedto Q3'22 ~0% growth comparedto Q2'23 Net Revenue (in $MM) Net Revenue (in $MM) Sis 51.6 61.6 51.6 a a ae iss Inventory Change($) Inventory Change($) rare rears a ao 2
Slide 6: Bottles Were Sold in Q3'23
ry Bottles Were Sold in Q3’23 ~10% decline compared to Q3'22 ~5% declinecomparedio Q2'23 Bottles a1or—_:Bottles seca 2874 2874 32022 32023 22023 93'2023 Inventory Change Bottles Inventory Change Bottles ars ox +0 +2 09 +2
Slide 7: ~71% of Patients in Q3'23 Started at a Reduced Dose
~71% of Patients in Q3’23 Started at a Reduced Dose* % of Patients Starting at Reduced Dose 69.5% 712% 65.4% eam ass e40% exon sax saan sax 97.7% 7% sax 10% anon 22% 19.0% 120% s1.0% 20% cox sosseelll ae | oe poh 08% 20920520 529 529 e988 09 9 9 0M 0M gM 9% oP PPP PP “Reduced dose defined as fewer t
Slide 8: Region
Region Australia / SEAsia Canada Latin America Europe Greater China Middle East North and West Aftica ‘South Africa Turkey South Korea Partner Specialised * Therapeutics MEDISON Knight Dvir enanwa Pierre Fabre Regulatory Approvals 2019 — Ext. Adj. in Australia, Singapore 2020 — Ext. Adin Brunei, Mal
Slide 9: HER2+ Breast Cancer Market Size
rant HER2+ Breast Cancer Market Size @ Approximately 28,300 patients (US) with early stage HER2+ breast cancer treated with adjuvant treatment' m@ Approximately 6,000 patients (US) with HR positive early stage HER2+ breast cancer and no pathological complete response to neoadjuvant treatment (high r
Slide 10: Guidance for Q4 and FY 2023
juidance for Q4 and FY 2023 Q4 2023 Full Year 2023 m NERLYNX revenue guidance: $56 - $59 million $206 to $209 million m NERLYNX royalty guidance: $16 - $19 million $30 - $32 million m@ Net income guidance: $13 - $16 million $22 - $25 million
Slide 11: Alisertib
ALISERTIB Breast Cancer and Small-Cell Lung Cancer
Slide 12: Alisertib (MLN 8237)
Alisertib (MLN 8237) Orally Bioavailable N—\ Drug Class: Benzazepine Aurora Kinase A (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),
Slide 13: 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 survival! + Loss of function of Rb1 is a common event in cancer and - a can emerge as a mechanism of resistance to EGFR, rd wy tc CDK4, and ER-targeted therapies
Slide 14: 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 x =* =m proliferation Genomic instability & : tumor development AURKA and c-Myc transcriptionally upregulate each other, suggesting the existence of a positive feedback loop c
Slide 15: Clinical Development in Small-Cell Lung Cancer
Clinical Development in Small-Cell Lung Cancer
Slide 16: Phase II Study of Alisertib Monotherapy in Solid Tumors - SCLC Cohorts
Phase 2 Study of Alisertib Monotherapy in Solid Tumors - SCLC Cohorts Study desi 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 14 day
Slide 17: Phase II Study of Alisertib Monotherapy in Solid Tumors - SCLC Cohorts
Phase 2 Study of Alisertib Monotherapy in Solid Tumors - SCLC Cohorts 10 (21%; 95% Cl 10-35) of 48 patients had an objective response; all responders achieved a partial response Chemotherapy-sensitive relapse Il Refractory or chemotherapy resistant elapse Change in target lesion size and best respon
Slide 18: Phase II Study of Alisertib Monotherapy in Solid Tumors - SCLC Cohorts
Phase 2 Study of Alisertib Monotherapy in Solid Tumors - SCLC Cohorts All-cause adverseeventsin safety evaluable SCLC cohort(n=60) Gaiet? Gade coh Dayan Mam) sex) 20%) ass) 1607) 1607) 18005) 40%) sass) 18000) 10a) sex 8039) wus sex 40) 40) a0) 7am cs) 60%) 368) 27%) nam sax 200) a0 400 109 610%) 10
Slide 19: Randomized Phase II Study of Paclitaxel plus Alisertib vs Paclitaxel plus Placebo
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 +
Slide 20: Randomized Phase II Study: 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 + ais
Slide 21: Randomized Phase II Study: 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
Slide 22: Randomized Phase II Study: Safety
Randomized Phase 2 Study of Paclitaxel plus Alisertib vs Paclitaxel plus Placebo as Second-Line SCLC: Safety ‘Asertib/Paclitaxel (n= 87) Placebo/Pactitaxel (0 = 89) Ae day Grade Grade 23 day Grade “Grade >3 Aieaue aE AO Se) Te Bo sen Diarrhea. 51.69) 14416) 1820) 1) Fatigue 34) 9410) 233) 50) Nase 2
Slide 23: 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 50 mg po BID on days 1-7 of every 21-day Measurable disease per RECIST v1.1 Must provide tissue biopsy, archiv
Slide 24: 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 25: Parallel Clinical and Biomarker Development
Parallel Clinical and Biomarker Development « Comprehensive biomarker strategy supports clinical development and commercialization ‘Amended ALI-4201 for biomarker defined populationto support potential Accelerated Approval Drug development Enrollment of ALI-4201 (up to 60 pts) > Ter Decision point a
Slide 26: Clinical Development of Alisertib in Breast Cancer
Clinical Development of Alisertib in Breast Cancer
Slide 27: Phase II Study of Alisertib Monotherapy in Solid Tumors - Breast Cancer Cohorts
Phase 2 Study of Alisertib Monotherapy in Solid Tumors - Breast Cancer Cohorts Study desig + 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 brea
Slide 28: Phase II Study of Alisertib Monotherapy in Solid Tumors - Breast Cancer Cohorts
Phase 2 Study of Alisertib Monotherapy in Solid Tumors - Breast Cancer Cohorts 9/49 patients (18%; 95% Cl 9-32) had an objective response; all responders achieved a partial response ipl negative positive HERD-negatve BB HER? postvelany HR Change in target lesion size and best response (investigator
Slide 29: Phase II Study of Alisertib Monotherapy in Solid Tumors - Breast Cancer Cohorts
Phase 2 Study of Alisertib Monotherapy in Solid Tumors - Breast Cancer Cohorts All-cause adverseeventsin safety evaluable breast cancer cohort (n=53) Connon Pree Perhelonn coh ehdaton aka e059) 26%) nw vax) 2649) ra) 15088) soy 60%) ness) naw e050) aon sar) sam 4a) sam 6a) sas%) 248) 50%) coke ues n
Slide 30: Phase II Randomized Trial of Alisertib + Fulvestrant vs Alisertib in Advanced HR+ Breast Cancer
Phase 2 Randomized Trial of Alisertib + Fulvestrant vs Alisertib in Advanced HR+ Breast Cancer Patients (n=96) Regimen & Schedule Inclusion Criteria + Alisertib + Fulvestrant: Alisertib 50mg PO + Postmenopausal women BiDon days 1-3, 8-10, 18-17 q 28-day cycle + Histologically-proven ER+ (>10% expres
Slide 31: Phase II Randomized Trial of Alisertib + Fulvestrant vs Alisertib
Phase 2 Randomized Trial of Alisertib + Fulvestrant vs Alise: Advanced HR+ Breast Cancer Reason for Allserib* —_| Alsertib + Fuvestrant Treatment (o=45) (0-45) Discontinuation Hematologic Adverse Events ‘Anemia Lymphocyte Count Decreased Neutropenia Count Decreased White Blood Cell Count Decreased '
Slide 32: Phase II Randomized Study of Paclitaxel + Alisertib vs Paclitaxel Alone
Phase 2 Randomized Study of Paclitaxel + Alisertib vs Paclitaxel Alone - Efficacy in ER+/HER2-MBC Cohort PFS in ER+/HER2-ITT Study desi 10 Median PFS: 10.2 (3.8-15.7) mo for pacitaxel + alisertib vs 7.1 (3.8-10.6) + Patients with ER+/HER2- or triple negative metastatic ‘mo with pacitaxel os breast c
Slide 33: Phase II Randomized Study: Efficacy in 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 34: 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 observedin palbociclib-resistant HR+ breast cancer cell lines, supporting a role for alisertib in this setting RB1 Loss C-Myc Upregulation MCF7-PR MCF7-PR Vs MCF7 == i sien ver re rors} 09 i
Slide 35: Study-related Neutropenia in Metastatic Breast Cancer
Study-related Neutropenia in Metastatic Breast Cancer - Alisertib compared to other agents | wa a ! ha Alisertib monotherapy 60 mg BID! 63%! Alisertib monotherapy 60 mg BID? Not reported? Alisertib 50 mg BID + fulvestrant® Not reported Alisertib 40 mg BID + paciitaxel® 67.9% Eribulin mesylate (HALAV
Slide 36: PUMA-ALI-1201
PUMA-ALI-1201 Phase 2 dose optimization, biomarker evaluation in HR+/HER- MBC Key inclusion criteria: + HR#/HER2- mBC patients who have received at least 2 prior lines of endocrine therapy in the recurrent or metastatic setting Must have received CDK4/6 inhibitors with endocrine therapy Disease recu
Slide 37: Intellectual Property for NERLYNX (neratinib)
We »perty 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 in extended
Slide 38: Intellectual Property for alisertib
roperty 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) m@ Use in the treatment of breast cancer (expires 2034) @ Additional patents being filed and pro
Slide 39: Property on EGFR T790M Mutations
rty on EGFR T790M Mutations m 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 European Opposit
Slide 40: Upcoming clinical milestones for alisertib
@ Initiate a Phase II clinical trial of alisertib in small cell lung cancer (H1 2024) Vv Conducta meeting with the FDA to discuss the clinical development and registration pathway for alisertib in hormone receptor-positive breast cancer (Q4 2023) @ Initiate a Phase II clinical trial of alisertib in
Slide 41: Alan H. Auerbach
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 Scientific, The Clorox Company Alvin W
Slide 42: Board of Directors
ard 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; Former
Slide 43: Currently trading on
We 5 Currently trading on NASDAQ: PBYI Cash, cash equivalents and marketable securities at September 30, 2023: $85 million Net income in Q3 2023: $5.8 million Cash earned in Q3 2023: $10.6 million Private placements: — March 2022: 3,584,228 shares issued to Alan Auerbach and Athyrium Capital Managem
Slide 44: Company Highlights
7 npany 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 45: Puma Biotechnology
Puma Biotechnology B. Riley Securities 4" Annual Oncology Conference January 2024
Puma Biotechnology — B. Riley Securities 4th Annual Oncology Conference (January 2024) on 6ix