Fennec Pharmaceuticals Inc. · NASDAQ:FENC
Fennec Pharmaceuticals — Investor Presentation (June 2017)
26 slides from Fennec Pharmaceuticals's investor presentation, June 2017
Slide 1: Corporate Presentation June 2017
Corporate Presentation June 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 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 for European Market Exclusivity for
Slide 5: Platinum Hearing Loss is Frequent, Severe and Irreversible
Platinum Hearing Loss is Frequent, Severe and Irreversible Each year in US and EU ~7000 children and adolescents receive platinum based chemotherapy for localized tumors, where overall survival is greater than 80%* At least 60% of children develop profound irreversible ototoxicity** • Ototoxicity is
Slide 6: 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 5
Slide 7: 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 8: Ototoxicity in Children Treated with Cisplatin and/or Carboplatin
Ototoxicity in Children Treated with Cisplatin and/or Carboplatin* • 61% bilateral hearing 100 loss (ASHA criteria) at the end of treatment 80 88 Ototoxicity (%) • 41% required hearing 75 60 67 aids that only partially restore hearing 40 50 • 22% of patients had 20 dose reductions due to ototoxicity
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 (Freyer 2016) Specific aims
COG ACCL0431 (Freyer 2016) Specific aims Primary • 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 Speech-Language-Hearing
Slide 11: COG ACCL0431 (Freyer 2016) Study Design
COG ACCL0431 (Freyer 2016) Study Design Cisplatin per investigator standard STS 16 g/m2 IV over STS Arm additional 15 min 6 hrs post chemotherapies each cisplatin dose allowed Cisplatin- containing Randomize Standard audiometry at baseline and ~24 chemotherapy hrs before each cisplatin course Cispla
Slide 12: 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 13: Hearing Loss By Randomized Arm
Hearing Loss By Randomized Arm 1 p = 0.004 Proportion with Hearing Loss 0.8 56.4% 0.6 0.4 31/55 28.6% 0.2 14/49 0 OBS STS n=104 evaluable patients 12
Slide 14: Hearing Loss By Randomized Arm and Age
Hearing Loss By Randomized Arm and Age 1 Proportion with Hearing Loss 0.8 73.3% 0.6 50.0% 0.4 31.4% 21.4% 0.2 0 Age <5 Age ≥5 OBS 11/15 (73.3%) 20/40 (50.0%) STS 31/55 (56.4%) 3/14 (21.4%) 14/49 11/35 (28.6%) (31.4%) p = 0.005 p = 0.103 13
Slide 15: Change in Mean Hearing Thresholds by Randomized Arm
Change in Mean Hearing Thresholds by Randomized Arm1 * NORMAL * *p < 0.05 for post-treatment comparison between arms * 1In patients with evaluable pre-post frequency-specific audiometry, n=84-94 14
Slide 16: EFS/OS for All Participants
EFS/OS for All Participants 15
Slide 17: 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) 16
Slide 18: 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 19: 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 20: SIOPEL 6 Preliminary Chemotherapy Efficacy
SIOPEL 6 Preliminary Chemotherapy Efficacy Tumor Response CIS CIS+STS N=52 N=53 Status at Complete Remission 44 (84.6%) 48 (90.5%) end of treatment Partial Response 4 ( 7.6%) 5 ( 9.4%) Progressive Disease 2 ( 4.5%) 0 Died 1 ( 1.9%) 0 Not Evaluable 1 ( 1.9%) 0 Status at Complete Remission 48 (92.3%)
Slide 21: SIOPEL 6 EFS/OS by Randomized Arm
SIOPEL 6 EFS/OS by Randomized Arm Median Follow-Up 36 Months EFS OS 2yr-EFS Cis 82.4%, CIS+STS 82.6% 2yr-OS Cis 91.9%, Cis+STS 97.9% 20
Slide 22: Conclusion
Conclusion • 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) SR-HB • Homogenous Disease, Excellent Prognosis • Very Young Children / hearing loss
Slide 23: European Named Patient Program
European Named Patient Program • Launched European Named Patient Program (NPP) May 2017 for SR-HB – Grants access to STS prior to approval to address serious unmet medical need in pediatric patients with SR-HB, where there is a reasonable expectation that the provision of early access to STS will be
Slide 24: STS: Development Strategy
STS: 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 Data J
Slide 25: Capital Structure and Share Information
Capital Structure and Share Information Stock Listings FRX – TSX, Canada FENCF – OTCQB, USA Current Share Price USD $4.40 Shares Outstanding (millions) 15.6 Market Cap. (millions) USD $68.6 Warrants (millions) 1.3 with USD $1.50 exercise price (Nov. 22, 2018) Insider Ownership Approx. 9% fully dilut
Slide 26: 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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