Fennec Pharmaceuticals Inc. · NASDAQ:FENC
Fennec Pharmaceuticals — Investor Presentation (March 2018)
23 slides from Fennec Pharmaceuticals's investor presentation, March 2018
Slide 1: Corporate Deck 2018
FENNEC PHARMA [x CORPORATE DECK 2018
Slide 2: Safe Harbor Statement
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 potential action of the
Slide 3: Platinum-Based Chemotherapy: Cisplatin
PLATINUM-BASED CHEMOTHERAPHY : CISPLATIN Cisplatin, a.k.a. “penicillin of cancer” was first introduced in the 1970s and subsequently demonstrated high efficacy in the treatment of a variety of pediatric tumors Despite the approval of new chemotherapy treatments, targeted agents and immunotherapy dru
Slide 4: Company Overview
COMPANY OVERVIEW US-based biopharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in children with cancer. 7.5 YEARS MARKET EXCLUSIVITY FDA Orphan Drug Designation 10 YEARS UPON APPROVAL E
Slide 5: Platinum Hearing Loss Effects
PLATINUM HEARING LOSS EFFECTS Ototoxicity is a dose-limiting side effect Effects can be seen after as little as the second or third dose Loss of high frequency hearing sensitivity (consonants /f/th/p/k/h/t) Background noise compounds disability in critical settings Infants . and young children at cr
Slide 6: Devastating Impact on Quality of Life
DEVASTATING IMPACT ON QUALITY OF LIFE Even minimal hearing loss is damaging. Long term follow up of neuroblastoma survivors with hearing loss. Grade Setbacks High risk for being held back a grade (37% versus 3%). Learning Problems Twice the rate of parents reported problems with reading, math, atten
Slide 7: Risk Factors
RISK FACTORS Probability of Brock’s Level 2 or worse hearing loss. Children <5 years old: 21 times the risk for hearing loss compared to adolescents *Li et al., European Journal of Cancer, 2004, 40(16):2445-2451 FENNEC PHARMA 7 CORPORATE DECK MARCH 2018
Slide 8: Market Opportunity
MARKET OPPORTUNITY Annual incidence of pediatric solid tumor cases eligible for Platinum-Based Therapy in both American and European markets. 3,554 ~30% ~70% 1,462 Low to High Risk Intermediate Risk U.S. EUROPEAN MARKET MARKET 5,016 5,925 3,554 ~30% ~70% 1,462 Low to High Risk Intermediate Risk *Sou
Slide 9: Sodium Thiosulfate (STS)
SODIUM THIOSULFATE (STS) Indication Mechanism of Action* Approved in US and some EU • Anticancer activity of cisplatin occurs countries for the treatment of during the first two hours after cyanide poisoning. administration when the free (unbound) cisplatin distributes into Drug Delivery the cancer
Slide 10: Proof of Concept Study
PROOF OF CONCEPT STUDY COG ACCL0431 | Freyer 2016 Primary Endpoint • Evaluate efficacy of STS for prevention of hearing loss in children receiving cisplatin chemotherapy (hypothesis: 50% relative reduction in hearing loss). Measured by hearing status at 4 weeks post-therapy defined by American Speec
Slide 11: Participant Characteristics
PARTICIPANT CHARACTERISTICS COG ACCL0431 | Freyer 2016 CONTROL STS FENNEC PHARMA 11 CORPORATE DECK MARCH 2018
Slide 12: Hearing Loss: Randomized Arm
HEARING LOSS: RANDOMIZED ARM COG ACCL0431 | Freyer 2016 FENNEC PHARMA 12 CORPORATE DECK MARCH 2018
Slide 13: EFS/OS: All Participants
EFS/OS: ALL PARTICIPANTS COG ACCL0431 | Freyer 2016 FENNEC PHARMA 13 CORPORATE DECK MARCH 2018
Slide 14: EFS/OS: Extent of Disease
EFS/OS: EXTENT OF DISEASE* COG ACCL0431 | Freyer 2016 Localized Disease (n=77) Disseminated Disease (n=47) *Determined post hoc (ie, retrospectively during the preliminary data analysis after completion of accrual) FENNEC PHARMA 14 CORPORATE DECK MARCH 2018
Slide 15: Pivotal Study
PIVOTAL STUDY SIOPEL 6 Objectives Primary Endpoint • Assess the efficacy of STS to reduce the hearing • Centrally reviewed absolute impairment caused by Cisplatin in SR-HB. hearing threshold, at the age of • Monitor any potential impact of STS on response ≥3.5 yrs, by pure tone (protocol pre-specifi
Slide 16: SIOPEL 6 Methods & Design
SIOPEL 6 METHODS & DESIGN • Cisplatin alone : IV infusion over 6 hrs (80 mg/m2 • Stratification by Country, age (above and below 15 for children > 10kg, 2.7 mg/kg for infants and months), PRETEXT (I and II vs III). children 5-10kg or 1.8 mg/kg for infants < 5kg), • Serum sodium monitored 1 hr, 6 hrs
Slide 17: Hearing Loss by Randomized Arm – SIOP 2017
HEARING LOSS BY RANDOMIZED ARM – SIOP 2017 FENNEC PHARMA 17 CORPORATE DECK MARCH 2018
Slide 18: Sensitivity of Hearing Loss by Brock Grade
SENSITIVITY OF HEARING LOSS BY BROCK GRADE SIOP 2017 | 99pts have centrally reviewed audiometry. FENNEC PHARMA 18 CORPORATE DECK MARCH 2018
Slide 19: EFS/OS: Randomized Arm
EFS/OS: RANDOMIZED ARM SIOPEL 6 | Median Follow-Up 52 months EFS OS 3yr-EFS Cis 78.8% | CIS+STS 82.1% 3yr-OS Cis 92.3% | CIS+STS 98.2% FENNEC PHARMA 19 CORPORATE DECK MARCH 2018
Slide 20: Conclusion: COG ACCL0431 and SIOPEL 6
CONCLUSION COG ACCL0431 SIOPEL 6 • STS prevents cisplatin related The addition of STS significantly hearing loss in the heterogeneous reduces the incidence of cisplatin- COG ACCL0431 population induced hearing loss without any (Freyer 2016). evidence of tumor protection (SIOP 2017). • Its effect is
Slide 21: PEDMARK Development Strategy
PEDMARK DEVELOPMENT STRATEGY TM SIOPEL 6 Final FDA Type C Clinical COG ACCL0431 NDA/MAA Efficacy and Safety Development Meeting Phase 3 Clinical Data Submissions Results MAR. 2011 NOV. 2011 JUN. 2014 JUN. 2017 OCT. 2017 2017—2018 2H 2018 Presented to Launched EU Named FDA & EMA Pediatric ODAC Patien
Slide 22: Capital Structure | Share Information
CAPITAL STRUCTURE | SHARE INFORMATION Stock Listings FENC – NASDAQ | FRX – TSX, Canada INSTITUTIONAL OWNERSHIP Current Share Price USD $10.00 Southpoint Capital – 22% Shares Outstanding 18.4M Leadiant Bio (Sigma Tau) – 19% Manchester Management – 8% Market Cap. USD $184M 683 Capital – 6% Warrants (M
Slide 23: Board of Directors & Management
BOARD OF DIRECTORS & MANAGEMENT Rosty Raykov | CEO & Board Member Dr. Khalid Islam | Chairman Adrian Haigh | Director Chairman & CEO at Gentium S.p.A. Currently SVP & General Manager Robert Andrade | CFO Sold to Jazz Pharma for $1 billion. PTC Therapeutics. Previously COO at Gentium S.p.A. Sold to J
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