Fennec Pharmaceuticals Inc. · NASDAQ:FENC
Fennec Pharmaceuticals — Investor Presentation (August 2022)
31 slides from Fennec Pharmaceuticals's investor presentation, August 2022
Slide 1: August 2022 | Corporate Presentation
August 2022 | Corporate Presentation www.fennecpharma.com
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 th
Slide 3: Fennec Pharmaceuticals, Inc. | A Snapshot
Fennec Pharmaceuticals, Inc. | A Snapshot Focused on the development of PEDMARK™ for the prevention of cisplatin-induced ototoxicity in pediatric patients with localized, non-metastatic solid tumors* TWO successfully completed and published, Potential for 7.5 YEARS U.S. market exclusivity randomized
Slide 4: FENNEC | Management Team
FENNEC | Management Team A dedicated management team with more Rosty Raykov than a decade of commitment to the CEO & Director development of PEDMARK and nearly two Robert Andrade decades of demonstrated experience and Chief Financial Officer commercialization success within the oncology space Mark M
Slide 5: FENNEC | Board of Directors
FENNEC | Board of Directors Dr. Khalid Islam | Chairman Dr. Marco Brughera | Director Dr. Islam has over 30 years of experience in Dr. Brughera is Group Chief Executive Officer at Leadiant Biosciences S.p.A. Dr. Brughera has extensive experience in drug development, portfolio optimization, business
Slide 6: FENNEC | Capital Structure and Share Information
FENNEC | Capital Structure and Share Information Stock Listings Current FENC – Nasdaq |FRX – INSTITUTIONAL OWNERSHIP4 TSX,Canada Southpoint Capital 16% Shares Outstanding 26.1 Million Essetifin 16% Cash and Cash Equivalents1 USD $14.9 Million Sonic Fund 9% 2021 Cash Burn2 USD $14.2 Million Debt3 $5
Slide 7: PEDMARK | Development Timeline
PEDMARK | Development Timeline TM DEC MAR JUN 2016 2018 2018 SEP March 2018 2022 SIOPEL 6 data Patient COG ACCL0431 Fast Track and published in New Focused Drug published in Breakthrough Therapy England Journal of Development NDA resubmission September 23, 2022 Lancet Oncology Granted by FDA Medicin
Slide 8: Pediatric Oncology Incidence is Consistent in U.S. and EU
Pediatric Oncology Incidence is Consistent in U.S. and EU Annual incidence of pediatric solid tumor cases eligible for Platinum-based therapy in both U.S. and EU markets* U.S Market 5,016 European Market 5,925 ~30% 1,462 Metastatic ~30% 1,710Metastatic ~70% 3,554 Localized, non-metastatic ~70% 4,215
Slide 9: Cisplatin is the Standard of Care for Pediatric Solid Tumors
Cisplatin is the Standard of Care for Pediatric Solid Tumors Cisplatin | Penicillin of Chemotherapy Common Childhood Cancers Treated • Interferes with DNA replication killing fast with Cisplatin proliferating cells • Brain and CNS cancers • Administered as intravenous infusion in normal • Neuroblast
Slide 10: One of the unfortunate complications with cisplatin therapy is ototoxicity
One of the unfortunate complications with cisplatin therapy is ototoxicity Corporate Deck 10
Slide 11: Cisplatin Results in High-Frequency Hearing Loss in Children
Cisplatin Results in High-Frequency Hearing Loss in Children Common Clinical Presentation of Hearing Loss Risk Factors for Ototoxicity1,2 • High frequency (≥4 kHz) sensorineural hearing loss1,2 • Younger age (<5 years of age) ‒ Bilateral (both ears) • Cranial irradiation ‒ Progressive • Total dose a
Slide 12: Ototoxicity Can Occur Early in Treatment - As Early As Cycles 1-2
Ototoxicity Can Occur Early in Treatment - As Early As Cycles 1-21 -10 0 • Ototoxicity is a cisplatin dose-limiting Hearing threshold level in dB 10 toxicity1 meaning that efficacy of 20 chemotherapy could be compromised 30 due to ototoxicity management 40 50 • Effects can be seen as soon as the 60
Slide 13: Clinical Manifestations
Clinical Manifestations Effects on growth and development Speech Impairment • Certain consonants (f/th/p/k/h/t) are inaudible, compromising speech recognition and comprehension in young children1 Career Limitations Social Isolation • High frequency hearing loss affects recognition of plurals (Lost E
Slide 14: The Impact of Ototoxicity is Profound
The Impact of Ototoxicity is Profound • The overall 5-year survival rate for children with localized, non-metastatic disease is close to 80%, making the permanent and progressive impact of ototoxicity an important consideration1, yet audiological follow up, today, is inconsistent • Current intervent
Slide 15: Ototoxicity Can Have a Devastating Impact
Ototoxicity Can Have a Devastating Impact Long term follow up of neuroblastoma • High risk for being held back a grade survivors with hearing loss (37% vs. 3%)1 50 • Twice the rate of parents reported learning 40 problems with reading, math, attention and need for special education2 Retention Rate %
Slide 16: Treatment-Induced Hearing Loss and Adult Social Outcomes in Survivors
Treatment-Induced Hearing Loss and Adult Social Outcomes in Survivors of Childhood Non-CNS Solid Tumors | Results From the St. Jude Lifetime Cohort Study1 Among 226 survivors of non-CNS tumors*: • 39% had severe hearing loss; 20% of these patients had hearing aids or cochlear implants • 39% were not
Slide 17: Until Now, Intervention for Ototoxicity Was Not Preventative
Until Now, Intervention for Ototoxicity Was Not Preventative Intervention occurs after hearing loss has been detected Hearing Aids1 Cochlear Implants1 • Do not block out background noise • A surgically implanted neuro-prosthetic device to provide a • Unable to separate speech and noise in loud modif
Slide 18: PEDMARK™: Unique Formulation of Sodium Thiosulphate (STS)
PEDMARK™ Unique Formulation of Sodium Thiosulphate (STS) Development* Intended Mechanism of Action • Anticancer activity of cisplatin occurs during the first two hours • We believe PEDMARK* is the only agent that is after administration when the free (unbound) cisplatin distributes specifically in d
Slide 19: PEDMARK™ | Development and Regulatory Status
PEDMARK™ | Development and Regulatory Status Two Randomized Studies Complete: Regulatory Milestones Achieved: Proof of Concept Study | COG ACCL0431 • Granted Fast Track and Breakthrough Therapy Designation by FDA • 131 patients with heterogeneous solid tumors • Positive opinion on PIP received by PD
Slide 20: Proof of Concept Study | COG ACCL0431
Proof of Concept Study | COG ACCL0431 Cisplatin-containing chemotherapy Primary Endpoint Secondary Endpoints STS ARM Randomize OBS ARM • Evaluate efficacy of STS for • Compare change in mean prevention of hearing loss in hearing thresholds children receiving cisplatin Cisplatin per investigator Cisp
Slide 21: COG ACCLO431 | Study Patient Characteristics
COG ACCLO431 | Study Patient Characteristics n CONTROL % n STS % Number Eligible 64 61 <5 22 34 22 36 5–9 13 20 7 11 Patients with Localized or Disseminated Age (years) Diagnoses 10 – 14 14 22 16 26 15 – 18 15 23 16 26 Germ Cell Tumor 16 25 16 26 Hepatoblastoma 5 8 2 3 Medulloblastoma/PNET 14 22 12
Slide 22: COG ACCLO431 | Primary Outcome (Hearing Loss)
COG ACCLO431 | Primary Outcome (Hearing Loss) Primary Endpoint 48% Reduction in Risk of Hearing Loss 70% Reduction in Risk of Hearing Loss Freyer et al, www.thelancet.com/oncology Vol 18 January 2017 Corporate Deck 22
Slide 23: COG ACCLO431 | EFS and OS in ITT (All Patients)
COG ACCLO431 | EFS and OS in ITT (All Patients) Per Protocol | Monitor Event Free Survival (EFS) and Overall Survival (OS) (no formal comparison) Freyer et al, www.thelancet.com/oncology Vol 18 January 2017 Corporate Deck 23
Slide 24: COG ACCLO431 | Post Hoc Analysis of EFS and OS
COG ACCLO431 | Post Hoc Analysis of EFS and OS* Localized Disease (n=77) Disseminated Disease (n=47) Freyer et al, www.thelancet.com/oncology Vol 18 January 2017 *Determined post hoc (i.e., retrospectively during the preliminary data analysis after completion of accrual). Corporate Deck 24
Slide 25: Pivotal Study | SIOPEL 6
Pivotal Study | SIOPEL 6 Objectives Primary Endpoint Secondary Endpoints • Assess the efficacy of STS to reduce the hearing • Centrally reviewed absolute • Response, resection, EFS, impairment caused by cisplatin in SR-HB hearing threshold, at the age of OS and long-term renal • Monitor any potentia
Slide 26: SIOPEL 6 | Study Design
SIOPEL 6 | Study Design CIS CIS CIS CIS CIS CIS Diagnostic D E L AY E D S U R G E R Y biopsy RANDOMISE Assessment of response Tumor and blood Assessment of response storage and resectability Radiologic Staging CIS CIS CIS CIS CIS CIS STS STS STS STS STS STS CIS Cisplatin alone: IV infusion over 6 hr
Slide 27: SIOPEL 6 | Primary Outcome (Hearing Loss)
SIOPEL 6 | Primary Outcome (Hearing Loss) p = 0.002 Consistent with COG study, there was a 48% decrease in the risk of hearing loss 63.0% 29/46 32.7% 18/55 N = 101 evaluable patients Brock et al, N Engl J Med 2018;378:2376-85. Corporate Deck 27
Slide 28: SIOPEL 6 | Hearing Loss Sensitivity by Brock Grade
SIOPEL 6 | Hearing Loss Sensitivity by Brock Grade Hearing grade level : Brock grades 1-4 100 90 Bilateral Hearing Loss Grade Designation % Patients with Hearing Loss 80 < 40 dB at all frequencies 0 Minimal 70 >= 40 dB at 8kHz only 1 Mild 60 2 50 11 >= 40 dB at 4kHz and above 2 Moderate 40 >= 40 dB
Slide 29: SIOPEL 6 | Secondary Endpoints EFS and OS
SIOPEL 6 | Secondary Endpoints EFS and OS Median Follow-Up 52 months 3yr-EFS: 3yr-OS : CIS 92.3% CIS+STS 98.2% CIS 78.8% CIS+STS 82.1% Brock et al, N Engl J Med 2018;378:2376-85. Corporate Deck 29
Slide 30: SIOPEL 6 Study | KOL Perspectives
SIOPEL 6 Study | KOL Perspectives “Taken together, these trials provide definitive evidence “We agree with Freyer et al. that drawing conclusions for that sodium thiosulfate reduces the incidence of clinical practice from our trial and ACCL04311 would support cisplatin-induced hearing loss and sugge
Slide 31: FENNEC PHARMA
FENNEC PHARMA
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