Fennec Pharmaceuticals Inc. · NASDAQ:FENC
Fennec Pharmaceuticals — Adherex Technologies — Investor Presentation (March 2013)
18 slides from Fennec Pharmaceuticals's investor presentation, March 2013
Slide 1: Corporate Presentation March 2013
Corporate Presentation March 2013
Slide 2: Safe Harbor Statement
Adherex Technologies Safe Harbor Statement During the course of this presentation we will make statements that constitute forward- looking statements. These statements may include operating expense projections, the initiation, timing and results of pending or future clinical trials, the actions or p
Slide 3: Phase 2 Clinical Trial for Metastatic Breast Cancer (MBC)
Phase 2 Clinical Trial for Metastatic Breast Cancer (MBC) Eniluracil (EU) + 5-fluroruracil (5-FU) + Leucovorin (Lv) vs. Xeloda® (capecitabine*) (crossover option) * Xeloda® is an oral prodrug of 5-FU and registered trademark of Genentech, a member of the Roche Group 3
Slide 4: Investment Highlights
Investment Highlights EU/5-FU/Lv is active and well tolerated in MBC patients Final comparative efficacy and safety data to be reported during 2Q/3Q 2013 Patients who rapidly failed Xeloda® (N=9) who were subsequently treated with EU/5-FU/Lv experienced the following: 89% had clinical benefit
Slide 5: 5-FU Metabolic Pathways
5-FU Metabolic Pathways 5-FU must be activated to kill cancer cells The enzyme, DPD, prevents activation and degrades 5-FU to F-BAL (Degradation) DPD problems: F-BAL problems: Highly Variable levels >80% of dose = F-BAL Unpredictable, non-linear 5-FU PK Decreases 5-FU Efficacy 5-FU t1/2 = 10-20 min
Slide 6: EU Inactivates DPD
EU Inactivates DPD EU Eliminates DPD & F-BAL Problems 5-FU is not destroyed: F-BAL formation is minimal: Half-life = 5 hr. No interference with efficacy Highly predictable, linear PK Minimize neurotoxicity Safe dosing of Lv HFS is negligible Oral dosing 6
Slide 7: Encouraging Comparison
Encouraging Comparison Dr. Grem’s Phase I Weekly Schedule vs. Xeloda®’s Phase 2 in Advanced Colorectal* Cancer Refractory to iv 5-FU/Lv Outcome EU/5-FU/Lv Xeloda® 20mg/29mg/m2/30mg 1,250mg/m2 Treatment weekly every 12 hr for 3 weeks for 14 days Tumor Responses 2/17 0/22 Diarrhea 65 (17) % 74 (26) %
Slide 8: Modified Weekly Schedule
Modified Weekly Schedule The weekly EU/5-FU/Lv schedule was modified as described in Adherex patent filings The all oral regimen: Administers a higher EU dose to eliminate all DPD, including DPD in nervous tissue to minimize neurotoxicity Allows excess EU to be cleared before dosing with 5-FU Admini
Slide 9: Phase 2 Oral 5-FU Regimens
Phase 2 Oral 5-FU Regimens Arm 1: Modified Weekly Schedule: taken 3 weeks followed by 1 week interlude EU Dose: 40 mg (11-16 hr before 5-FU) 5-FU Dose: 30 mg/m2 EU:5-FU will be ≤ 1:10 + Leucovorin Dose: 30 mg Leucovorin Dose: 30 mg Arm 2: 1000 mg/m2 Xeloda® twice daily for 14 days followed by 7 days
Slide 10: Study Design
Study Design N = 140: first- or second-line therapy for MBC patients who had previous Prior to treatment with an anthracycline and a taxane Enrollment Randomize Treat and Assess 80 Subjects 60 Subjects As Per Protocol Arm 1 Arm 2 Stop Treatment Other Other PD X-over PD Because of: Reasons Reasons Op
Slide 11: Preliminary Interim Results
Preliminary Interim Results* Main Study: EU/5-FU/Lv vs. Xeloda® Evaluated CR PR SD CR + PR + SD1 Arm patients n (%) n (%) n (%) n (%) Arm 1: EU/5-FU/Lv 68 1 (1) 16 (24) 35 (51) 52 (76) Arm 2: Xeloda® 54 0 (0) 14 (26) 26 (48) 40 (74) Crossover Option: Xeloda® failures who crossed over to take EU/5-FU
Slide 12: Rapid Xeloda Failures
Rapid Xeloda® Failures Arm 2 Patients Who Rapidly Failed Xeloda® and Crossed Over to Take EU/5-FU/Lv in Arm X Adjuvant/Neoadjuvant Patient Arm X Arm 2 5-FU Treatment(s) Best Best PFS1 (Days) PFS (Days) Response Response 1 2322 SD 38 PD No 2 212 SD 41 PD Yes 3 124 PR 41 PD Yes 4 28 PD 41 PD Yes 5 335
Slide 13: Rapid Xeloda Failures - Progression-Free Survival
Rapid Xeloda Failures -Progression-Free Survival 13
Slide 14: Mechanisms for EU/5-FU/Lv clinical benefit
Mechanisms for EU/5-FU/Lv clinical benefit The possible mechanisms for rapid Xeloda® failure and subsequent clinical benefit from EU/5-FU/Lv may include any of the following: 1. Low Xeloda® absorption (highly variable with possible extended lag periods) 2. Low or deficient levels of one or more of t
Slide 15: Eniluracil US MBC Market Opportunity
Eniluracil US MBC Market Opportunity* $400 Substantial pipeline of opportunities outside initial indication $350 $300 > $250 M $ in Millions $250 > $200 M $200 > $150 M Additional $150 Available Pts. Est. 3-4k > $120 M Halaven (3rd Line) $100 Ixempra (After Xeloda Fail) 11.0% Response $50 Eligible P
Slide 16: Financial Snapshot
Financial Snapshot Stock Listings AHX – TSX, Canada ADHXF – USA Shares Issued 25,157,861 Warrants 18,034,769 with $1.44 exercise price (Approx. CDN$26,000,000 on exercise of all warrants) Options 5,410,000 (Approx. CDN$7,000,000 on exercise of all options) Insider Ownership Approx. 50% fully diluted
Slide 17: Management and Board of Directors
Management and Board of Directors Rosty Raykov – CEO David Lieberman – Chairman Donaldson, Lufkin & Jenrette, Tiedemann Group. Bear Stearns, Tiedemann Group, John Levin & Currently, an analyst with Southpoint Capital, Co., Alchem and DCML Co. Company’s largest shareholder Robert Andrade – CFO Chris
Slide 18: Summary
Summary Preliminary Interim Results – December 2012 Patients who rapidly failed Xeloda® (N=9) who were subsequently treated with EU/5-FU/Lv experienced the following: 89% had clinical benefit 33% had tumor response Ongoing median progression-free survival of 117 days vs. 42 days while on Xelod
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