Zenith Capital Corporation · OTC:ZHCLF
Zenith Capital — Zenith Epigenetics — Shareholder Meeting (January 2025)
25 slides from Zenith Capital's shareholder meeting presentation, January 2025
Slide 1: AGM Discussion and Q & A
AGM Discussion and Q & A NUT Carcinoma Lead Program January 2025
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation may contain certain forward-looking information as defined under applicable securities legislation, that are not based on historical fact, including without limitation forward looking information relating to Zenith’s development activities. Zenith’s actua
Slide 3: Introduction
Introduction M&A Opportunity The NUT Carcinoma Story BET Bromodomain Inhibition Response Example FDA Expedited pathway Commercial Analysis and Forecast Cencora Commercialization Support Study Executive Market Size Summary Targeted Sales Force Strategy Summary Additional Indications in Progress Zenit
Slide 4: M&A Opportunity Based on NUT Carcinoma Results
M&A Opportunity Based on NUT Carcinoma Results Opportunity Overview • To acquire the rights to a best-in-class bromodomain (BET) inhibitor program. The M&A process and OPPORTUNITY pricing will be based on the lead program, NUT Carcinoma. Additional indications are included and confirmatory trials ar
Slide 5: NUT Carcinoma is an underdiagnosed, rare oncology indication
NUT Carcinoma is an underdiagnosed, rare oncology indication Disease Overview DISEASE CHARACTERISTICS UNMET NEEDS NUT carcinoma: A rare, highly aggressive and previously underdiagnosed squamous carcinoma characterized by a single translocation involving the NUTM1 gene and different partner genes Epi
Slide 6: BET inhibitors work at the epigenetic level and suppress cancer growth
BET inhibitors work at the epigenetic level and suppress cancer growth by modulating oncogene expression Transforming Combination Therapy in Oncology Gene expression and production of proteins regulated by epigenetics Cancer cells highjack gene expression machinery to propagate Cancer cells also dev
Slide 7: Compassionate use NUT Carcinoma patient achieved near complete response with ZEN-3694
A compassionate use NUT Carcinoma patient achieved near complete response with single agent ZEN-3694 Compassionate Use Case 12/9/22 3/7/23 10/5/22 (treatment started) (Response) • Progressing on bone and lung lesions prior to treatment • 12/18/22 : Single agent ZEN-3694 treatment started at 48mg/qd
Slide 8: FDA Expedited Pathway Planning Progress
FDA Expedited Pathway Planning Progress Key findings – 50% Objective Response Rate (ORR) Achievable in NUT Carcinoma Single Agent and Combination therapy development: efficacy and duration of response • Both mono and combo approaches have established 48 mg, by utilizing a standard 3 plus 3 dosing ap
Slide 9: Introduction
Introduction M&A Opportunity The NUT Carcinoma Story BET Bromodomain Inhibition Response Example FDA Expedited pathway Commercial Analysis and Forecast Cencora Commercialization Support Study Executive Market Size Summary Targeted Sales Force Strategy Summary Additional Indications in Progress Zenit
Slide 10: Cencora Commercialization Support Study - KOL and payer pricing interviews
Cencora Commercialization Support Study - formal KOL and payer group pricing interviews Methodology Interviews & Discussions with Clinical KOLs Limited KOLs available globally for NUT due to rarity of cancer; interviewed >90% top KOLs in the field KOL Payer Medical Oncologist Pharmacy Director Dana
Slide 11: Executive Market Size Summary
Executive Market Size Summary ZEN-3694 Revenue in NUT Carcinoma (US, CA, EU3) – Post this analysis, Australian and other high IHC usage markets will also be targeted Base Case Inputs Assumptions 10-year Revenue Forecast in NUT Carcinoma (USD $, M) Base case Total Incidence 5000 US, CAN + EU3 (2024)
Slide 12: Targeted Sales Force Strategy
Targeted Sales Force Strategy - based around concentrated COEs can be used in NUT Carcinoma Commercial Upside: Targeted Sales Force CENTRES OF EXCELLENCE (COE) FOR NUT CARCINOMA COMMERCIAL IMPLICATION Targeted sales force due to concentrated COEs Estimated 1 COE per country for ex-US Strong existing
Slide 13: Summary - NUT Carcinoma program: two ongoing trials, $400M peak revenue opportunity
Summary - The NUT Carcinoma program has two ongoing trials, presenting a $400M USD peak revenue opportunity in the US, CA & EU3 Program Overview CURRENT PROGRAM COMMERCIAL IMPLICATIONS Stage: Combinations: Partners: Phase Multiple Peak Market Size: 5,000 (2023 estimate) 1b/2 >2500 (diagnosed cases p
Slide 14: Introduction
Introduction M&A Opportunity The NUT Carcinoma Story BET Bromodomain Inhibition Response Example FDA Expedited pathway Commercial Analysis and Forecast Cencora Commercialization Support Study Executive Market Size Summary Targeted Sales Force Strategy Summary Additional Indications in Progress Zenit
Slide 15: PI Initiated/ Compassionate Use Update
PI Initiated/ Compassionate Use Update ➢ 10 NCI and 2 other PI initiated trials are ongoing, ➢ Most trials in late stage dose escalation with progression to dose expansion in 1H 2025 • Addressing AEs with protocol modifications etc. and optimizing dosing regimen ➢ PRs noted in 5 combination trials w
Slide 16: Phase 1 Study of ZEN-3694 with Cetuximab and Encorafenib in BRAF V600E Colorectal Cancer
A Phase 1 Study of ZEN003694 (ZEN-3694) in Combination with Cetuximab and Encorafenib in Patients with Refractory BRAF V600E Metastatic Colorectal Cancer Protocol 10605 Scott Kopetz, M.D.(PI), Salvador Alonso, M.D. (co-P.I.) skopetz@mdanderson.org salonso1@mdanderson.org 11/8/24
Slide 17: Phase 1/1b ZEN003694 + Nivolumab +/- Ipilimumab in solid tumors and ovarian cancer
Phase 1/1b ZEN003694 + Nivolumab +/- Ipilimumab in solid tumors and ovarian cancer Mahdi, UPitt NCT04840589 6 evaluable at DL1 ZEN-3694 + Nivolumab +/- Ipilimumab 3 evaluable at DL2 3 evaluable with triple combo Metastatic or recurrent solid tumors (no BRCA selection) Metastatic or recurrent solid t
Slide 18: ETCTN Trial 10579: ZEN-3694 with Capecitabine in Solid Tumors
ETCTN Trial 10579: Phase I Trial of ZEN003694 (ZEN-3694) in Combination with Capecitabine in Patients with Solid Tumors Dennis Hsu, MD Hillman Cancer Center University of Pittsburgh November 8th, 2024 djh138@pitt.edu / ETCTN10579@upmc.edu
Slide 19: Phase 1 ZEN-3694 + binimetinib in RAS pathway alterations and TNBC
Phase 1 ZEN-3694 + binimetinib in patients with RAS pathway alterations and TNBC Piha-Paul Meric-Bernstam, MDACC NCT05111561 mTNBC and solid tumors with RAS Pathway Activation (KRAS, NRAS, HRAS, BRAF, NF1) ZEN-3694 + Binimetinib DL-1 ZEN-3694 PO QD (36 mg) + Binimetinib PO BID (45 mg) 28 day cycles
Slide 20: NCI 10449: ZEN003694 with Binimetinib in Solid Tumors and TNBC
NCI 10449: A PHASE 1 STUDY OF ZEN003694 IN COMBINATION WITH BINIMETINIB IN SOLID TUMORS WITH RAS PATHWAY ALTERATIONS AND TRIPLE NEGATIVE BREAST CANCER MDACC Local Protocol 2022-0244 Principal Investigator: Sarina Piha-Paul, MD University of Texas, MD Anderson Cancer Center
Slide 21: NRG - GY031
NRG - GY031 A PHASE IB STUDY OF COMBINATION ATR (M1774) AND BET INHIBITION (ZEN003694) TO EXPLOIT ARID1A LOSS IN RECURRENT OVARIAN AND ENDOMETRIAL CANCER @NRGOnc NRG Oncology
Slide 22: Phase 1b trial of ZEN-3694 with pembrolizumab and nab-paclitaxel in TNBC
A phase 1b trial of ZEN-3694 with pembrolizumab and nab-paclitaxel in patients with metastatic triple-negative breast cancer Overall PI: Ana C. Garrido-Castro, MD Translational PI: Geoffrey Shapiro, MD, PhD Statistician: Nabihah Tayob, PhD NCI CTEP Meeting – Nov 8, 2024
Slide 23: NCI10486 – Phase 2 ZEN-3694 and Talazoparib (ComBET)
NCI10486 – Phase 2 trial of the Combination of the BET inhibitor, ZEN-3694, and the PARP inhibitor Talazoparib in Patients with Molecularly-Selected Solid Tumors (ComBET) Zenith Meeting November 2024 Timothy A. Yap, MBBS, PhD, FRCP Professor, Department of Investigational Cancer Therapeutics (Phase
Slide 24: Our Partners and Collaborators
Our Partners and Collaborators Zenith Epigenetics Overview | 24
Slide 25: NUT Carcinoma First To Market Focused Program Collaborators and Contact Information
NUT Carcinoma “First To Market Focused” Program Collaborators: Contact Information: Donald J. McCaffrey CEO Zenith Epigenetics Ltd #300, 4820 Richard Road SW Calgary, Alberta, Canada T3E 6L1 Phone +1-403-690-8887 email: don@zenithepigenetics.com Zenith Epigenetics | 25
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