Fennec Pharmaceuticals Inc. · NASDAQ:FENC
Fennec Pharmaceuticals — Investor Presentation (September 2014)
26 slides from Fennec Pharmaceuticals's investor presentation, September 2014
Slide 1: Corporate Presentation September 2014
Corporate Presentation September 2014
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 • Biopharmaceutical company dedicated to the development of novel cancer therapeutics • Two late stage clinical products: Sodium Thiosulfate (STS) and Eniluracil (EU) – STS: Received FDA Orphan Drug Designation with 7.5 yrs. pediatric exclusivity upon approval. – Positive data from
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 40-90% develop profound irreversible ototoxicity* • Ototoxicity is a dose-limiting side effect • Effect can be seen after 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: 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 • 135 randomized
Slide 9: COG ACCL0431: Specific Aims
COG ACCL0431: Specific Aims Primary • Evaluate efficacy of STS for prevention of hearing loss in children receiving cisplatin chemotherapy (hypothesis: 50% relative reduction in hearing loss) Secondary • Compare change in mean hearing thresholds • Compare incidence of other Grade 3/4 toxicities (ren
Slide 10: COG ACCL0431 Study Design
COG ACCL0431 Study Design STS Arm STS 16 g/m2 IV Cisplatin per treatment over 15 min 6 hrs protocol post each cisplatin dose Cisplatin- based Randomize Standard audiometry at baseline and protocol ~24 hrs before each cisplatin course Cisplatin per treatment protocol OBS Arm Audiometry at 4 weeks and
Slide 11: Hearing Loss By Randomized Arm
Hearing Loss By Randomized Arm Proportion with Hearing Loss 1.00 0.90 0.80 0.70 0.60 0.50 0.40 0.30 0.20 0.10 0.00 OBS STS 56% 31/55 (56.4%) 29%(28.6%) 14/49 n=104 evaluable patients / p = 0.004
Slide 12: Hearing Loss By Randomized Arm and Age
Hearing Loss By Randomized Arm and Age 1.00 Proportion with Hearing Loss 0.90 p = 0.005 p = 0.103 0.80 0.70 0.60 0.50 0.40 0.30 0.20 0.10 0.00 Age <5 Age 5+ OBS 11/15 11/1573% (73.3%) (73.3%) 20/40 20/40 (50.0%) 50% (50.0%) 3/14(21.4%) 3/14 (21.4%) 11/35(31.4%) 11/35 (31.4%) STS 21% 31% n=104 evalua
Slide 13: 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
Slide 14: 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 15: 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 16: 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 0.00 STS 0.00 0 1 2 3 4 5 Time (years) 0 1 2 3 4 5 Time (yea
Slide 17: SIOPEL 6 - Efficacy of STS in Reducing Ototoxicity in Hepatoblastoma Patients
SIOPEL 6 - Efficacy of STS in Reducing Ototoxicity in Patients Receiving Cisplatin for Hepatoblastoma Patients D E L A Y E D cDDP 80 mg/m2 cDDP R A N D O M I S A T I O N 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 80% power to d
Slide 18: SIOPEL 6: Randomized Phase 3 Study of STS in Hepatoblastoma
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 after cisplatin treatment • Study Chair: Peppy Brock, MD • 108 of 112 rand
Slide 19: STS Market Opportunity
STS Market Opportunity Pediatric Market Opportunity • Approximately 2,000 children receive platinum-based chemotherapy for localized disease in the US each year • Approximately 5,000 children receive platinum-based chemotherapy for localized disease in RoW each year Competitive Position • No alterna
Slide 20: Market Research; Oncologists Comments
Market Research; Oncologists Comments Pediatric oncologists were asked to comment on how the availability of STS would impact their treatment of patients. • “This product will definitely [address unmet needs]. It would probably become standard front- line therapy.” • “This product sounds very good.
Slide 21: Market Research Payers Comments
Market Research Payers Comments Payers were asked to provide comments regarding potential STS coverage decisions. General Comments: • “I think this could be the drug that changes how people practice. It would be malpractice NOT to use this when you’re giving platinum.” • “This is truly an unmet need
Slide 22: STS: Development Timeline
STS: Development Timeline 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 cisplatin and Nov 2011 agreed adult study would not be appropriate COG ACCL0431 Phase 3 Clinical Data H
Slide 23: STS Investment Highlights
STS Investment Highlights • Significant unmet medical need with no approved treatment on market or in development • US Orphan Drug Designation (7.5 years market exclusivity) • Positive data from COG Phase 3 trial in localized disease • SIOPEL 6 safety data shows no tumor protective effect to this da
Slide 24: Management and Board of Directors
Management and Board of Directors BOARD OF DIRECTORS MANAGEMENT Rosty Raykov – Chairman and CEO Rosty Raykov – Chairman and CEO Adrian Haigh – Director Paul Dreyer – Commercial Development Khalid Islam – Director Lei Fang – Biostatistics Chris Rallis – Director Krysia Lynes – CFO Steve Skolsky – Dir
Slide 25: Appendix: COG Patient Characteristics
Appendix: COG Patient Characteristics Characteristic Observation (%) STS (%) Eligible 64 62 Age at enrollment (yrs) <5 22 (34.4) 22 (35.5) ≥5 42 (65.6) 40 (64.5) Sex Male 41 (64.1) 35 (56.5) Female 23 (35.9) 27 (43.5) Race White 39 (60.9) 43 (69.4) Black 10 (15.6) 5 (8.1) Other/Unknown 15 (23.4) 14
Slide 26: Appendix: Patient Characteristics, continued
Appendix: Patient Characteristics, continued Characteristic Observation (%) STS (%) Diagnosis 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 Dise
Fennec Pharmaceuticals — Investor Presentation (September 2014) on 6ix