Fennec Pharmaceuticals Inc. · NASDAQ:FENC
Fennec Pharmaceuticals — Investor Presentation (December 2017)
23 slides from Fennec Pharmaceuticals's investor presentation, December 2017
Slide 1: Corporate Presentation December 2017
Corporate Presentation December 2017
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 Chemotherapy Cisplatin • Cisplatin, a.k.a. “penicillin of cancer” first introduced in the 1970s and subsequently demonstrated high efficacy in the treatment of variety of pediatric tumors • Despite the approval of new chemotherapy treatments, targeted agents and immunotherapy drugs, c
Slide 4: Company Overview
Company Overview • US based biopharmaceutical company focused on the development of PEDMARK TM(a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in children with cancer – Granted FDA Orphan Drug Designation – 7.5 years market exclusivity – Potential
Slide 5: Platinum Hearing Loss is Frequent, Severe and Irreversible
Platinum Hearing Loss is Frequent, Severe and Irreversible At least 60% of children develop profound irreversible ototoxicity* • Ototoxicity is a dose-limiting side effect • Effect can be seen after as little as the second or third dose • Loss of high frequency hearing sensitivity (consonants /f/th/
Slide 6: Devastating Impact on Quality of Life
Devastating Impact on Quality of Life Even minimal hearing loss (MSHL) is damaging • High risk for being held back a grade (37% versus 3%) Neuroblastoma survivors with hearing loss • Twice the rate of parent reported problems with reading, math, attention and need for special education • Poorer chil
Slide 7: Cisplatin Ototoxicity Risk Factors
Cisplatin Ototoxicity Risk Factors Children < 5 years old: 21 times the risk for hearing loss compared to adolescents Li et al., 2004 6
Slide 8: Pediatric Market Opportunity – U.S. and Europe
Pediatric Market Opportunity – U.S. and Europe U.S. Europe Pediatric Solid 5,016 5,925 Tumor Cases Eligible for Platinum-Based Therapy ~30% ~70% ~30% ~70% High-Risk Low-to-Intermediate Risk High-Risk Low-to-Intermediate Risk 1,462 3,554 1,711 4,214 Brain Tumors CNS Tumors Neuroblastoma Bone Tumors G
Slide 9: Sodium thiosulfate (STS)
Sodium thiosulfate (STS) Indication • Approved in US and some EU counties for the treatment of cyanide poisoning Mechanism of Action* • Anticancer activity of cisplatin occurs during the first two hours after administration when the free (unbound) cisplatin distributes into the cancer cells • Inacti
Slide 10: COG ACCL0431 Specific Aims and Study Design
COG ACCL0431 (Freyer 2016) Specific Aims and Study Design Primary • Evaluate efficacy of STS for prevention of hearing loss in children receiving cisplatin Cisplatin per investigator chemotherapy (hypothesis: 50% relative STS Arm standard STS 16 g/m2 IV over additional 15 min 6 hrs post reduction in
Slide 11: Participant Characteristics
Participant Characteristics Treatment Characteristic Control STS n % n % Number eligible 64 - 61 - Age (years) <5 22 34.4 22 36.1 5-9 13 20.3 7 11.5 10-14 14 21.9 16 26.2 15-18 15 23.4 16 26.2 Diagnosis Germ cell tumor 16 25.0 16 26.2 Hepatoblastoma 5 7.8 2 3.2 Medulloblastoma/PNET 14 21.9 12 19.7 N
Slide 12: Hearing Loss By Randomized Arm
Hearing Loss By Randomized Arm Overall Hearing Data Protocol Predefined Subgroup Age <5 1 p = 0.004 1 p = 0.005 Proportion with Hearing Loss Proportion with Hearing Loss 0.8 0.8 73.3% 0.6 56.4% 0.6 0.4 0.4 11/15 31/55 28.6% 21.4% 0.2 0.2 14/49 3/14 0 0 OBS STS OBS STS N = 104 evaluable patients 11
Slide 13: EFS/OS for All Participants
EFS/OS for All Participants 12
Slide 14: EFS/OS by Extent of Disease
EFS/OS by Extent of Disease* Localized Disease (n=77) Disseminated Disease (n=47) *Determined post hoc (ie, retrospectively during the preliminary data analysis after completion of accrual) 13
Slide 15: Pivotal Study: SIOPEL 6 Objectives, Population, and Endpoints
Pivotal Study: SIOPEL 6 Objectives, Population, and Endpoints Objectives • To assess the efficacy of STS to reduce the hearing impairment caused by Cisplatin in SR-HB • To carefully monitor any potential impact of STS on response (protocol pre-specified IDMC tumour response review at 20, 40, 60, 80
Slide 16: SIOPEL 6 Study Methods and Design
SIOPEL 6 Study Methods and Design Diagnostic CIS CIS CIS R A N D O M I S E biopsy CIS CIS CIS S U R G E R Y D E L A Y E D Tumour and blood storage Radiologic CIS CIS CIS CIS CIS CIS Staging STS STS STS STS STS STS Assessment of response Assessment of response and resectability • cisplatin alone : IV
Slide 17: Hearing Loss By Randomized Arm – SIOP 2017
Hearing Loss By Randomized Arm – SIOP 2017 1 p = 0.0033 0.8 Proportion with Hearing Loss 67.0% 0.6 0.4 30/45 37.0% 0.2 20/54 0 CIS CIS+ STS n=99 evaluable patients 16
Slide 18: Hearing Results: % Brock Grades by Treatment Arm
Hearing Results: % Brock Grades by Treatment Arm (99 pts have centrally reviewed audiometry) 70% 60% CIS CIS+STS 50% 40% 30% 20% 10% 0% 0 1 2 3 4 Brock Grades 17
Slide 19: SIOPEL 6 EFS/OS by Randomized Arm
SIOPEL 6 EFS/OS by Randomized Arm 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% 18
Slide 20: Conclusion
Conclusion COG ACCL0431 • STS prevents cisplatin related hearing loss in the heterogeneous COG ACCL0431 population (Freyer 2016) • Its effect is even more pronounced in the predefined subgroup of children < 5 years (Freyer 2016) SIOPEL 6 • The addition of STS significantly reduces the incidence of c
Slide 21: PEDMARK: Development Strategy
PEDMARKTM: Development Strategy EVENT TIMING FDA Type C Clinical Development Meeting Mar 2011 Presented to Pediatric ODAC ODAC recognized challenge of demonstrating STS does not reduce efficacy of Nov 2011 cisplatin and agreed adult study would not be appropriate COG ACCL0431 Phase 3 Clinical Da
Slide 22: Capital Structure and Share Information
Capital Structure and Share Information Stock Listings FENC – NASDAQ FRX – TSX, Canada Current Share Price USD $9.00 Shares Outstanding (millions) 18.3 Market Cap. (millions) USD $165 Warrants (millions) 1.3 with USD $1.50 exercise price (Nov. 22, 2018) Insider Ownership Approx. 9% fully diluted Cas
Slide 23: Board of Directors and Management
Board of Directors and Management Dr. Khalid Islam – Chairman Rosty Raykov – CEO and Board – Chairman and CEO at Gentium S.p.A. - Member sold to Jazz Pharma for $1 billion. Robert Andrade – CFO Dr. Marco Brughera– Director – Currently CEO and Global Head of Lei Fang – Biostatistics Lediant Bio (Sigm
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