Fennec Pharmaceuticals Inc. · NASDAQ:FENC
Fennec Pharmaceuticals — Investor Presentation (August 2018)
25 slides from Fennec Pharmaceuticals's investor presentation, August 2018
Slide 1: August 2018 Corporate Deck
August 2018 | Corporate Deck
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 Introduction: 1980s, “Penicillin of Cancer” Ototoxicity Demonstrated high efficacy in the treatment of a variety Is permanent, severe and irreversible of solid pediatric tumors Effects Can cause irreversible high frequency hearing loss, or ototoxicity in child
Slide 4: Company Overview
COMPANY OVERVIEW US-based biopharmaceutical company focused on the development of PEDMARK (a unique TM formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in children with solid tumors 7.5 YEARS US MARKET EXCLUSIVITY Pediatric Orphan Drug Designation 10 YEARS
Slide 5: Company Overview
COMPANY OVERVIEW Proof of Concept Study: COG ACCL0431 Granted Fast Track and Breakthrough 131 patients with heterogeneous solid tumors Therapy Designation by FDA Achieved primary efficacy endpoint - ASCO 2014 Final results: Lancet Oncology - December 2016 Positive opinion on Pediatric Investigation
Slide 6: Platinum Hearing Loss Effects
PLATINUM HEARING LOSS EFFECTS Ototoxicity Disability Is often a dose-limiting side effect Background noise compounds disability in critical settings Effects Speech Language Can be seen after as little as the second or Infants and young children at critical stage of development, third dose lack speec
Slide 7: Devastating Impact on Quality of Life
DEVASTATING IMPACT ON QUALITY OF LIFE 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, attention and need for special education Quali
Slide 8: Risk Factors
RISK FACTORS Probability of Brock’s Level 2 or worse hearing loss Probability (ratio) Cumulative cisplatin dose (mg/m2) *Y. Li et al. | European Jounal of Cancer 40 (2004) 2445-2451 Children <5 years old: 21 times the risk for hearing loss compared to adolescents August 2018 | Corporate Deck 8
Slide 9: Market Opportunity
MARKET OPPORTUNITY Annual incidence of pediatric solid tumor cases eligible for Platinum-Based Therapy in both US and EU markets U.S Market 5,016 European Market 5,925 ~30% 1,462 High Risk ~30% 1,711 High Risk ~70% 3,554 Low to Intermediate Risk ~70% 4,215 Low to Intermediate Risk *Sources: Company
Slide 10: PEDMARK: Sodium Thiosulfate (STS)
PEDMARK: SODIUM THIOSULFATE (STS) Indication Mechanism of Action* Approved in US and some EU countries for the nticancer activity of cisplatin occurs during the first A treatment of cyanide poisoning two hours after administration when the free (unbound) cisplatin distributes into the cancer cells D
Slide 11: Proof of Concept Study
PROOF OF CONCEPT STUDY Cisplatin-containing chemotherapy COG ACCL0431 | Lancet Oncology 2016 STS ARM Randomize OBS ARM 1 Primary Endpoint Evaluate efficacy of STS for prevention of hearing loss in Cisplatin per investigator Cisplatin per investigator children receiving cisplatin chemotherapy (hypoth
Slide 12: Participant Characteristics
PARTICIPANT CHARACTERISTICS n CONTROL % n STS % Number Eligible 64 – 61 – <5 22 34.4 22 36.1 Age (years) 5–9 13 20.3 7 11.5 10 – 14 14 21.9 16 26.2 15 – 18 15 23.4 16 26.2 Germ Cell Tumor 16 25.0 16 26.2 Hepatoblastoma 5 7.8 2 3.2 Diagnosis Medulloblastoma/PNET 14 21.9 12 19.7 Neuroblastoma 12 18.8
Slide 13: Hearing Loss Randomized Arm
HEARING LOSS RANDOMIZED ARM COG ACCL0431 | Lancet Oncology 2016 August 2018 | Corporate Deck 13
Slide 14: EFS/OS: All Participants
EFS/OS: ALL PARTICIPANTS COG ACCL0431 | Lancet Oncology 2016 August 2018 | Corporate Deck 14
Slide 15: EFS/OS: Extent of Disease
EFS/OS: EXTENT OF DISEASE * Localized Disease (n=77) Disseminated Disease (n=47) COG ACCL0431 | Lancet Oncology 2016 *Determined post hoc (ie, retrospectively during the preliminary data analysis after completion of accrual). August 2018 | Corporate Deck 15
Slide 16: Pivotal Study
PIVOTAL STUDY SIOPEL 6 | New England Journal of Medicine 2018 Objectives Primary Endpoint Assess the efficacy of STS to reduce the hearing 1 Centrally reviewed absolute hearing threshold, impairment caused by Cisplatin in SR-HB at the age of ≥3.5 yrs, by pure tone audiometry, graded by Brock criteri
Slide 17: SIOPEL 6 Methods & Design
SIOPEL 6 METHODS & DESIGN Cisplatin alone : IV infusion over 6 hrs (80 mg/m2 for children > 10kg, 2.7 mg/ Stratification by Country, age (above and below 15 months), kg for infants and children 5-10kg or 1.8 mg/kg for infants < 5kg) PRETEXT (I and II vs III) OR Serum sodium monitored 1 hr, 6 hrs and
Slide 18: Hearing Loss: Randomized Arm
HEARING LOSS: RANDOMIZED ARM p = 0.002 63.0% 29/46 32.7% 18/55 N = 101 evaluable patients SIOPEL 6 | New England Journal of Medicine 2018 August 2018 | Corporate Deck 18
Slide 19: Sensitivity of Hearing Loss by Brock Grade
SENSITIVITY OF HEARING LOSS BY BROCK GRADE Bilateral Hearing Loss Grade Designation < 40 db at all 0 Minimal frequencies >= 40 dB at 1 Mild 8kHz only >= 40 dB at 4kHz 2 Moderate and above >= 40 dB at 2kHz 3 Marked and above >= 40 dB at 1Khz 4 Severe and above * A Brock grade of 0 indicates hearing a
Slide 20: EFS/OS: Randomized Arm
EFS/OS: RANDOMIZED ARM Median Follow-Up 52 months SIOPEL 6 | New England Journal of Medicine 2018 August 2018 | Corporate Deck 20
Slide 21: Conclusion
CONCLUSION COG ACCL0431 SIOPEL 6 Lancet Oncology 2016 New England Journal of Medicine 2018 STS prevents cisplatin related hearing The addition of STS significantly reduces loss in the heterogeneous COG ACCL0431 the incidence of cisplatin-induced hearing population loss without any evidence of tumor
Slide 22: PEDMARK Development Timeline
PEDMARK TM DEVELOPMENT TIMELINE Presented to COG ACCL0431 FDA & EMA SIOPEL 6 data published Commence Pediatric ODAC at FDA published at Regulatory Meetings in New England Journal NDA/MAA Lancet Oncology of Medicine Submissions NOV. 2011 JUN. 2014 DEC. 2016 OCT. 2017 2017 - 2018 MAR. 2018 JUN. 2018 A
Slide 23: Capital Structure | Share Information
CAPITAL STRUCTURE | SHARE INFORMATION Stock Listings FENC – NASDAQ | FRX – TSX, Canada INSTITUTIONAL OWNERSHIP Current Share Price USD $10.44 Southpoint Capital – 22% Shares Outstanding 18.9M Leadiant Bio – 19% Market Cap. USD $197M Manchester Mgmt – 8% Warrants* 1M with USD $1.50 exercise price 683
Slide 24: Board of Directors & Management
BOARD OF DIRECTORS & MANAGEMENT Dr. Khalid Islam | Chairman Rosty Raykov | CEO & Board Member Former Chairman & CEO at Gentium S.p.A. Sold to Jazz Pharma for $1 billion. Robert Andrade | CFO Dr. Marco Brughera | Director Currently CEO & Global Head of Leadiant Bio (Sigma Tau Rare Disease). Mark Gowl
Slide 25: For Further Information, Please Contact
FOR FURTHER INFORMATION, PLEASE CONTACT: Rosty Raykov, Chief Executive Officer, Fennec Pharmaceuticals Inc. T: (919) 636-5144 or [email protected] Investor Relations contact: [email protected]
Fennec Pharmaceuticals — Investor Presentation (August 2018) on 6ix