Fennec Pharmaceuticals Inc. · NASDAQ:FENC
Fennec Pharmaceuticals — Investor Presentation (August 2015)
30 slides from Fennec Pharmaceuticals's investor presentation, August 2015
Slide 1: Corporate Presentation August 2015
Corporate Presentation August 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: 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 5: 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 6: Ototoxicity in Children Treated with Cisplatin and/or Carboplatin
Ototoxicity in Children Treated with Cisplatin and/or Carboplatin* 61% bilateral hearing loss 100 (ASHA criteria) at the end 80 88 of treatment Ototoxicity (%) 75 41% required hearing aids 60 67 that only partially restore 50 40 hearing 20 22% of patients had dose reductions due to ototoxicity 11 0
Slide 7: Target and Proposed STS Mechanism
Target and Proposed STS Mechanism • Requires both Cl unbound to NH3 Antitumor Effect crosslink DNA • Binding to plasma proteins occurs Cl within first hour which inactivates NH3 Pt one binding site Cl • Free cDDP (unbound) short t1/2 :1.5 hr Ototoxicity Effect • Requires one Cl unbound to affect NH3
Slide 8: SIOPEL 6: Rand. Phase 3 Study - Efficacy of STS in Reducing Ototoxicity
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 9: 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 10: 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/m2 cDDP 4 Cycles 2 Cycles S U R G E R Y cDDP 80 mg/m2 STS: 10-20 gm/m2 cDDP + STS depending on age/weight 2 Cycles 4 Cycles 9
Slide 11: 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 12: 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%) 11
Slide 13: 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%) Hypomagnesaemia 3 1 (1.9%) 1 (1.8%) Hypermatremia 3 0 1 (1.8%) Vomitin
Slide 14: 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 15: COG ACCL0431: Randomized Phase 3 Study of STS
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 16: 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 17: 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 18: 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 19: 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 18
Slide 20: 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 19
Slide 21: 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 20
Slide 22: 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 21
Slide 23: 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 24: 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 25: 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 26: 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 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: 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 29: 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 30: 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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