Fennec Pharmaceuticals Inc. · NASDAQ:FENC
Fennec Pharmaceuticals — Investor Presentation (October 2016)
24 slides from Fennec Pharmaceuticals's investor presentation, October 2016
Slide 1: Corporate Presentation October 2016
Corporate Presentation October 2016
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: 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 4: 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 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 receive platinum based chemotherapy for localized tumors, where overall survival is greater than 80% At least 60% develop profound irreversible ototoxicity* • Ototoxicity is a dose-limiting side effect •
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: 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 8: Sodium thiosulfate (STS)
Sodium thiosulfate (STS) Indication • Approved in US and some EU counties for the treatment of cyanide poisoning Mechanism of Action* • STS is a competitive inhibitor of cisplatin: STS reacts irreversibly with cisplatin to form Pt(S2O3) which is not cytotoxic and is readily excretable • Inactivation
Slide 9: COG ACCL0431 Objectives, Population, Dosing
COG ACCL0431 (ASCO 2014) Objectives, Population, Dosing • Randomized study of STS for prevention of cisplatin-induced hearing loss in children - newly diagnosed children with, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, hepatoblastoma, and others • 131 randomized patients with loc
Slide 10: 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 9
Slide 11: 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 10
Slide 12: EFS/OS by Randomization Arm: All Patients
EFS/OS by Randomization Arm All Patients, n=126 at median f/u of 2.9 yrs EFS by Randomization Arm OS by Randomization Arm 1.00 1.00 0.75 0.75 Estimated Proportion 0.50 0.50 0.25 0.25 Observation Observation STS 0.00 STS 0.00 0 1 2 3 4 5 Time (years) 0 1 2 3 4 5 Time (years) Log Rank p = 0.31 Log Ran
Slide 13: EFS/OS by Randomization Arm: Localized Disease Only
EFS/OS by Randomization Arm Localized Disease Only, n=78 EFS by Randomization Arm (Localized Disease ) OS by Randomization Arm (Localized Disease) 1.00 1.00 0.75 Estimated Proportion 0.75 0.50 0.50 0.25 0.25 Observation Observation STS STS 0.00 0.00 0 1 2 3 4 5 0 1 2 3 4 5 Time (years) Time (years)
Slide 14: EFS/OS by Randomization Arm: Disseminated Disease Only
EFS/OS by Randomization Arm Disseminated Disease Only, n=47 EFS by Randomization Arm (Metastatic Disease) OS by Randomization Arm (Metastatic Disease) 1.00 1.00 0.75 0.75 Estimated Proportion 0.50 0.50 0.25 0.25 Observation Observation STS STS 0.00 0.00 0 1 2 3 4 5 0 1 2 3 4 5 Time (years) Time (yea
Slide 15: EFS, OS and Hearing Loss by Tumor Type
EFS,OS and Hearing Loss by Tumor Type Projected STS OBS STS OBS Hearing Hearing Tumor Type COG 2.9 yrs 2.9 yrs 2.9 yrs 2.9 yrs Loss Loss 3-year EFS EFS EFS OS OS STS OBS 14/16 13/16 15/16 16/16 3/15 Germ Cell 75% 0 (87.5%) (81.3%) (93.8%) (100%) (20%) Hepatoblastoma 60% 2/2 4/5 2/2 5/5 1/2 4/5 7/12
Slide 16: COG ACCL0431: Conclusions
COG ACCL0431: Conclusions • STS protects against cisplatin-induced hearing loss in children • Conclusions on the risk of tumour protection by STS in children treated with cisplatin confounded due to: – Heterogeneity of the population • Various diseases and tumor stages – Imbalances between prognosti
Slide 17: SIOPEL 6 Objectives, Population, and Endpoints
SIOPEL 6 (ASCO 2016) 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 and
Slide 18: SIOPEL 6 Preliminary Chemotherapy Efficacy
SIOPEL 6 (ASCO 2016) 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
Slide 19: SIOPEL 6 EFS/OS by Randomization Arm
SIOPEL 6 (ASCO 2016) EFS/OS by Randomization Arm Median Follow-Up 34 Months EFS OS 1.0 1.0 | | |||||| | || | | || || | ||| |||| | || | || || | | | | || | | | | | | | | || | || | ||||| | ||| ||||| |||| || | || || | | | | | | | | | || | || | | | ||| || | ||||| | |||||||||| || |||||| | || | | | | || ||
Slide 20: SIOPEL 6 Preliminary Conclusions
SIOPEL 6 (ASCO 2016) Preliminary Conclusions • Study is fully enrolled with 109 patients • It is safe to deliver Sodium Thiosulphate for otoprotection in Standard Risk Hepatoblastoma treated according to the SIOPEL 6 regimen • There is no evidence of tumor protection • The interim results of the fir
Slide 21: 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 22: Capital Structure and Share Information
Capital Structure and Share Information Stock Listings FRX – TSX, Canada FENCF – OTCQB, USA Current Share Price USD $2.03 Shares Outstanding (millions) 13.6 Market Cap. (millions) USD $27.6 Warrants (millions) 1.3 with USD $1.50 exercise price (Nov. 22, 2018) 0.4 with USD $3.60 exercise price (Dec.
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 Anne McKay – Regulatory Affairs Sigma Tau
Slide 24: STS Investment Highlights
STS Investment Highlights • Completed $5.0 million financing by Sigma Tau in May 2016 • US Orphan Drug Designation (7.5 years market exclusivity) • Potential for European Market Exclusivity for Pediatric Use (10 years) • Completed enrollment of two Phase 3 trials • COG Phase 3 trial achieved primary
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