Puma Biotechnology Inc · NASDAQ:PBYI

Puma Biotechnology — Technical Presentation (November 2019)

18 slides from Puma Biotechnology's technical presentation, Nov 6, 2019

  1. Slide 1: Puma Biotechnology SUMMIT Trial: Update on Regulatory Strategy

    Puma Biotechnology SUMMIT Trial Update on Regulatory Strategy November 6, 2019 Copyright 2019 Puma Biotechnology

  2. Slide 2: Forward-Looking Safe Harbor Statement

    Forward-Looking Safe Harbor Statement This presentation contains forward-looking statements, including statements regarding ongoing clinical studies and potential regulatory approvals for NERLYNX®. All statements other than historical facts are forward–looking statements and are based on the current

  3. Slide 3: Current SUMMIT 'Basket' Trial: Study Design

    Current SUMMIT ‘Basket’ Trial: Study Design EGFR exon18- Neratinib mutant tumors Lung monother EGFR, HER2 or HER4 mutations apy (documented by local testing) Cervical Primary endpoint • Objective response rate at first post- Neratinib baseline Salivary gland monother tumor assessment (ORRfirst) apy

  4. Slide 4: SUMMIT Hormone Receptor Positive Breast Cancer Cohort

    SUMMIT Hormone Receptor Positive Breast Cancer Cohort Copyright 2019 Puma Biotechnology 4

  5. Slide 5: Somatic Mutations in HER2 (ERBB2) in Hormone Receptor Positive Breast Cancer

    Somatic Mutations in HER2 (ERBB2) in Hormone Receptor Positive Breast Cancer • Incidence: HER2 somatic mutations - 7-9%, pre-treated ER+ MBC1 • Tumor characteristics: - usually mutually exclusive to HER2 amplifications • Preclinical evidence of oncogenic P P P P P activity: - constitutive activation

  6. Slide 6: Maximal Change in Tumor in RECIST Measurable HR positive/HER2-negative, HER2mut MBC Subjects

    Maximal Change in Tumor in RECIST Measurable HR positive/HER2- negative, HER2mut MBC Subjects Receiving Neratinib Monotherapy, N+F, or N+F+T and Grouped by Treatment Type and HER2mut Type Copyright 2019 Puma 6 Biotechnology

  7. Slide 7: Kaplan Meier Plot of Progression Free Survival for Breast Cancer Cohorts in SUMMIT

    Kaplan Meier Plot of Progression Free Survival for Breast Cancer Cohorts in SUMMIT (Efficacy Evaluable Population - HR positive/HER2- negative, HER2mut MBC Cohort and with RECIST Tumor Assessment) Copyright 2019 Puma 7 Biotechnology

  8. Slide 8: Proposed Amendment to Breast Cancer Cohort in SUMMIT to Support Accelerated Approval

    Proposed Amendment to Breast Cancer Cohort in SUMMIT for HR positive/HER2-negative, HER2mut MBC Cohort to Support Accelerated Approval HER2 mutations (documented by local testing) Primary endpoint • Objective response rate Secondary endpoints fulvestrant • DOR fulvestrant + Randomized 1:1:1 trastuzu

  9. Slide 9: SUMMIT Cervical Cancer Cohort

    SUMMIT Cervical Cancer Cohort Copyright 2019 Puma Biotechnology 9

  10. Slide 10: Characteristics of HER2 Mutant Cervical Cancer

    Characteristics of HER2 Mutant Cervical Cancer Incidence Histology Genomics 5% - Metastatic cervical Enriched in adenocarcinomas Most common HER2mut is cancers High occurrence in HPV+ S310 extracellular domain May be negatively prognostic tumors hotspot mutation for survival Usually exclusive to HER

  11. Slide 11: Neratinib Monotherapy Results Presented at SGO Meeting

    Neratinib Monotherapy Results Presented at SGO Meeting Copyright 2019 Puma 11 Biotechnology

  12. Slide 12: Neratinib Monotherapy Results Presented at SGO Meeting

    Neratinib Monotherapy Results Presented at SGO Meeting Copyright 2019 Puma 12 Biotechnology

  13. Slide 13: Path Forward

    Path Forward  SUMMIT study to enroll additional patients with HER2 mutated cervical cancer  Monotherapy data can be used to file for accelerated approval  Overall response rate  Duration of response  Puma to schedule pre NDA meeting with FDA (anticipated Q4 2020-Q2 2021) Copyright 2019 Puma Bio

  14. Slide 14: HER-Seq (PUMA-NER-9501): HER2 mutation screening protocol

    HER-Seq (PUMA-NER-9501): HER2 mutation screening protocol 14

  15. Slide 15: Why HER-Seq?

    Why HER-Seq? Rarity of HER2 mutation warrants an active screening 1 program Lack of access to genomic testing 2 • Ex-US regions Liquid biopsy is non-invasive and convenient 3 • Also facilitates repeat sampling Tracked by Puma from clinical presentation to neratinib trial 4 eligibility HER-Seq fills

  16. Slide 16: HER-Seq (PUMA-NER-9501) Study Protocol

    HER-Seq (PUMA-NER-9501) Study Protocol HER-Seq: A Blood-based Screening Study to Identify Patients with HER2 Mutations for Enrollment into SUMMIT (initiated December 2018) HER2 mutation Consider positive screening for neratinib treatment protocol Retest in 3-6 HER2 months Metastatic HER2 Test result

  17. Slide 17: HER-Seq Trial

    HER-Seq Trial  Currently open at ~15 sites  Being expanded to other SUMMIT sites  Utilizes proprietary next generation sequencing assay for HER2 mutations  Screening Goals: Breast cancer: Screen 2500 patients Cervical cancer: Screen 1200 patients  Patients with HER2 mutations identified through

  18. Slide 18: SUMMIT Trial Proposed Registration Pathway

    SUMMIT Trial Proposed Registration Pathway  Meet with FDA to discuss registration pathway in HR-positive, HER2 negative HER2 mutated breast cancer and HER2 mutated cervical cancer  Modify SUMMIT trial to expand HER2 mutated breast cancer cohort  Continue to enroll HER2 mutated cervical cancer coh

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