Fennec Pharmaceuticals Inc. · NASDAQ:FENC
Fennec Pharmaceuticals — Investor Presentation (June 2015)
28 slides from Fennec Pharmaceuticals's investor presentation, June 2015
Slide 1: Corporate Presentation
Corporate Presentation June 2015
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 pediatric patients – Granted FDA Orphan Drug Designation – 7.5 years market exclusivity – Potential for European Market Exclusivity for P
Slide 4: Capital Structure and Share Information
Capital Structure and Share Information Stock Listings FRX – TSX, Canada FENCF – OTCQB, USA Current Share Price USD$2.30 Shares Outstanding (millions) 10.9 Market Cap. (millions) USD$25.3 Warrants (millions) 1.3 with USD $1.50 exercise price (Nov. 22, 2018) 0.1 with USD $1.50 exercise price (Mar. 29
Slide 5: Board of Directors and Management
Board of Directors and Management Adrian Haigh – Director Rosty Raykov – Chairman and CEO – Currently SVP and General Manager Robert Andrade – Corp. Development PTC Therapeutics. Previously COO at Gentium S.p.A. - sold to Jazz Pharma for $1 billion. Anne McKay – Regulatory Affairs Dr. Khalid Islam –
Slide 6: Platinum Hearing Loss is Frequent, Severe and Irreversible
Platinum Hearing Loss is Frequent, Severe and Irreversible Globally, >7,000 children receive platinum based chemotherapy for localized cancers • USA: 2,000 EU: 3,000 RoW: 2,000 At least 60% develop profound irreversible ototoxicity* • Ototoxicity is a dose-limiting side effect • Effect can be seen a
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: COG ACCL0431: Randomized Phase 3 Study of STS for Prevention of Cisplatin-induced Hearing Loss
COG ACCL0431: Randomized Phase 3 Study of STS for Prevention of Cisplatin-induced Hearing Loss • Newly diagnosed children with hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and others • Local and metastatic disease • Study Chair: David Freyer, DO, MS • 131 randomized
Slide 9: COG ACCL0431: Specific Aims
COG ACCL0431: Specific Aims 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 Speech-Language-Hearing Ass
Slide 10: Patient Characteristics
Patient Characteristics Characteristic Observation (%) STS (%) Eligible 64 62 Germ Cell Tumor 16 (25.0) 16 (25.8) Osteosarcoma 15 (23.4) 15 (24.2) Medulloblastoma 14 (21.9) 12 (19.4) Neuroblastoma 12 (18.8) 14 (22.6) Hepatoblastoma 5 (7.8) 2 (3.2) Other 2 (3.1) 3 (4.8) Extent of Disease Localized 38
Slide 11: COG ACCL0431: Study Design
COG ACCL0431: Study Design STS Arm STS 16 g/m2 IV Cisplatin per investigator over 15 min 6 hrs standard post each cisplatin dose Cisplatin- containing Randomize Standard audiometry at baseline and chemotherapy ~24 hrs before each cisplatin course Cisplatin per investigator standard OBS Arm Audiometr
Slide 12: Hearing Loss By Randomized Arm
Hearing Loss By Randomized Arm 1 Proportion with Hearing Loss 0.8 0.6 0.4 0.2 0 OBS STS 31/55 (56.4%) 14/49 (28.6%) n=104 evaluable patients / p = 0.004 11
Slide 13: Hearing Loss By Randomized Arm and Age
Hearing Loss By Randomized Arm and Age 1 Proportion with Hearing Loss 0.8 0.6 0.4 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 12
Slide 14: Hearing Loss By Randomized Arm and Disease
Hearing Loss By Randomized Arm and Disease Proportion with Hearing Loss 1 0.8 0.6 0.4 0.2 0 Localized Disseminated OBS 17/33 (56.4%) 31/55 (51.5%) 14/22 14/49 (63.6%) (28.6%) STS 9/31 (29.0%) 5/18p =(27.8%) 0.067 p = 0.024 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 by Randomization Arm
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 17: 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 18: 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 19: COG ACCL0431: Conclusions
COG ACCL0431: Conclusions • STS protects against cisplatin-induced hearing loss in children • STS appears to be safe in patients with localized disease • Lower overall survival among children with disseminated cancer at onset of treatment, tumor protection or artifact?* * The protocol did not specif
Slide 20: SIOPEL 6: Randomized Phase 3 Study of STS in Hepatoblastoma Patients
SIOPEL 6: Rand. Phase 3 Study - Efficacy of STS in Reducing Ototoxicity in Hepatoblastoma Patients • Newly diagnosed children with standard risk hepatoblastoma • Single localized disease with very high historic survival rates • Cisplatin monotherapy treatment • Study Chair: Peppy Brock, MD, PhD, FRC
Slide 21: SIOPEL 6: Objectives and Primary Endpoint
SIOPEL 6: Objectives and Primary Endpoint Objectives: • To assess the efficacy of STS to reduce the hearing impairment caused by Cisplatin (CDDP) • To carefully monitor any potential impact of STS on response to CDDP and survival Primary endpoint: • Centrally reviewed absolute hearing threshold, at
Slide 22: SIOPEL 6 – Study Design
SIOPEL 6 – Study Design D E L AY E D R A N D O M I S A T I O N cDDP 80 mg/m 2 cDDP 4 Cycles 2 Cycles S U R G E R Y cDDP 80 mg/m 2 STS: 10-20 gm/m 2 cDDP + STS depending on age/weight 2 Cycles 4 Cycles 21
Slide 23: SIOPEL 6: Early Efficacy and Tolerability Results
SIOPEL 6: Early Efficacy and Tolerability Results ASCO 2015 Poster • Status at end of treatment (6 cycles) for 109 evaluable patients Cisplatin Cisplatin + STS Efficacy (n=52) (n=57) Complete response 44 (84.6%) 52 (91.2%) Stable disease 3 (5.8%) 4 (7.0%) Progressive disease 2 (3.9%) 0 Died (1) 1 (1
Slide 24: SIOPEL 6: Early Efficacy and Tolerability Results
SIOPEL 6: Early Efficacy and Tolerability Results ASCO 2015 Poster • Status at last follow up for 109 evaluable patients Cisplatin Cisplatin + STS Efficacy (n=52) (n=57) Complete Response 48 (92.3%) 52 (91.2%) Non CR 1 (1.9%) 3 (5.3%) Died 3 (5.8%) 1 (1.8%) Not available 0 1 (1.8%) 23
Slide 25: SIOPEL 6: Early Efficacy and Tolerability Results
SIOPEL 6: Early Efficacy and Tolerability Results ASCO 2015 Poster Grade 3 and 4 Acute Cisplatin Cisplatin + STS Toxicities (n=52) (n=57) Allergy 3 1 (1.9%) 0 Febrile neutropenia 3 4 (7.7%) 5 (8.8%) Infection 3 5 (9.6%) 6 (10.5%) Hypomagnesemia 3 1 (1.9%) 1 (1.8%) Hypermatremia 3 0 1 (1.8%) Vomiting
Slide 26: SIOPEL 6: Conclusions
SIOPEL 6: Conclusions ASCO 2015 Poster • This randomized phase III trial shows that it is safe to treat standard risk hepatoblastoma with six cycles of Cisplatin monotherapy with the addition of the chemoprotectant, Sodium Thiosulfate, provided that protocol instructions to add doxorubicin and stop
Slide 27: 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 28: STS Investment Highlights
STS Investment Highlights • 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 endpoint for hearing • SIOPEL 6 Phase 3 trial reported no a
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