Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Edge Therapeutics — Investor Presentation (October 2015)
27 slides from Pds Biotechnology's investor presentation, Oct 28, 2015
Slide 1: Edge Therapeutics, Inc. October 2015
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Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding our strategy, future operations, future financial position, fut
Slide 3: Clinical-stage biotechnology company overview
We are a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel, hospital-based therapies capable of transforming treatment paradigms in the management of acute, life-threatening conditions. Our lead product candidate, EG-1962, is in development to
Slide 4: Key Investment Highlights
Key Investment Highlights Lead Candidate EG-1962 is Phase 3-ready; could replace standard of care in aSAHTargeted and sustained release of standard of care nimodipine NEWTON Phase 1/2 data shows dramatic 2x improvement in favorable outcomes Superior safety profileGranted Orphan Designation in US and
Slide 5: Edge's Experienced Leadership Team
Edge’s Experienced Leadership Team Chairman of Scientific Advisory Board Robert Langer, PhD David H. Koch Institute Professor at MIT Biomedical Engineering Chairman of the Board of Directors Sol Barer, PhD Executive Management Team Brian A. Leuthner President & CEO, Co-founder, Director R. Loch Macd
Slide 6: Aneurysmal Subarachnoid Hemorrhage (aSAH)
Aneurysmal Subarachnoid Hemorrhage (aSAH) Bleeding into the subarachnoid space in the brain arising from a ruptured brain aneurysmBlood pools, encasing the brain arteriesPrimary and secondary brain injuryPatient DemographicsAverage Age = 5285-90% of patients make it alive to the hospital (35,000 ann
Slide 7: Current Management of aSAH
Current Management of aSAH Approved in 1989Reduce delayed ischemia / improve outcome within 96 hours of aSAHStandard of care >60 countries Treats multiple deleterious effects of calcium influx after aSAH Potent and unique dihydropyridine L-type Ca channel antagonist + + + + Only 17% of poorer grade
Slide 8: EG-1962 Differentiation and Existing Data
EG-1962 Differentiation and Existing Data
Slide 9: EG-1962 Differentiation: Targeted Delivery of Nimodipine Directly into the Brain
EG-1962 Differentiation: Targeted Delivery of Nimodipine Directly into the Brain EG-1962: One-time administration provides sustained exposure over 21 days; compliance benefit + Superior dosing convenience & Compliance Nimodipine PLGA EG-1962 Oral Nimodipine: Short half life (45-minutes); requires he
Slide 10: Key Clinical Scales Enrollment Outcome
Key Clinical Scales 10 | Confidential. Do not distribute. Enrollment Outcome
Slide 11: NEWTON Study - Key Highlights
NEWTON Study - Key Highlights North American study completed July 201572 patients enrolled; 54 EG-1962, 18 oral nimodipineMaximum feasible dose identified (primary endpoint)800 mg All patients tolerated administration Safety & tolerability established (primary endpoint)PK characterized up to 800 mg
Slide 12: EG-1962 Efficacy: Over 2x Improvement in Favorable Outcomes
EG-1962 Efficacy: Over 2x improvement in Favorable Outcomes in NEWTON Study 17 of 44 12 of 17 12 | Confidential. Do not distribute. * Hänggi D, Etminan N, Macdonald RL, Steiger, HJ. NEWTON - Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage. Neurocri
Slide 13: EG-1962 Efficacy: Outcome Improved Across All Doses
EG-1962 Efficacy: Outcome Improved Across All Doses
Slide 14: EG-1962 Efficacy: Clinical Benefit Across All Disease Severities
EG-1962 Efficacy: Clinical Benefit Noted With All Disease Severities WFNS 2 = Over 2x improvement in favorable outcome rateWFNS 4 = Nearly 2x improvement in favorable outcome rate Overall: Over 2x improvement in favorable outcome rate WFNS: World Federation of Neurological Surgeons Grading System fo
Slide 15: EG-1962 Safety: Summary of NEWTON Results
EG-1962 Safety: Summary of NEWTON Results (Cohorts 1-6) 15 | Confidential. Do not distribute. EG-1962100 – 1200 mg Oral nimodipine60mg x 4 hrs. x 21 days N (%) N (%) Death(Unrelated) 3/54 5.5 1/18 5.5 SAEs (Related) 1/54 1.8 0/18 0.0 Hypotension 0/54 0.0 3/18 16.7
Slide 16: Planned Pivotal Study Overview
Planned Pivotal Study Overview Phase 3 study comparing safety and efficacy of EG-1962 versus oral nimodipine Primary Endpoints Secondary & Health Economic Endpoint Proposed Study Sample Size Neurological outcome measured at 90 days after aSAH using GOSESafety profile of EG-1962 compared to oral nimo
Slide 17: Precisa Development Platform
Precisa™ Development Platform Proprietary, programmable, biodegradable polymer-baseddevelopment platform Optimize product Program release profileSpecific blend of polymers Initial release profileSustained release profile Define product profileIdentify therapeuticEngineer polymerPhysical / chemical p
Slide 18: Edge Pipeline Overview
Edge Pipeline Overview 18 | Confidential. Do not distribute.
Slide 19: EG-1964 for cSDH
EG-1964 for cSDH EG-1964 is a polymer-based therapeutic containing aprotinin for the management of cSDH as a prophylactic treatment to prevent recurrent bleeding Aprotinin: pancreatic trypsin inhibitor FDA approved in 1993 to prevent rebleeding following cardiac bypass surgeryMechanism of action pot
Slide 20: Chronic Subdural Hematoma (cSDH) Overview
Chronic Subdural Hematoma (cSDH) Overview 20 | Confidential. Do not distribute. cSDH is a liquefied hematoma that has accumulated on the surface of the brain in an area referred to as the subdural space Brain shrinks inside the skull as we ageEven minor head trauma can cause blood to leak into the s
Slide 21: Commercial Opportunity
Commercial Opportunity 21 | Confidential. Do not distribute.
Slide 22: Commercial Strategy
Commercial Strategy A small and targeted sales force of 50 representatives could cover the majority of hospitals in the United States and Canada Anticipate similar sized sales force in Europe 500 hospitals accountFor 75% of all aSAH patients Rapid adoption drivers: Strong relationships with key hosp
Slide 23: Compelling Value Proposition
Compelling Value Proposition Preventing delayed cerebral ischemia (DCI) saves hospitals and managed care organizations >$50,000 per patient, excluding outpatient rehab and nursing home 1. Cost of Vasospasm in Patients With Aneurysmal Subarachnoid Hemorrhage. Chou, Chia-Hung; Reed, Shelby D.; Allsbro
Slide 24: Three-layered approach to maintain high barrier-to-entry
Three-layered approach to maintain high barrier-to-entry 24 | Confidential. Do not distribute. 3 issued U.S. patents (including Composition of Matter), 12 issued foreign patents and more than 50 U.S. and foreign pending patent applications Potentially difficult for competitors to prove bioequivalenc
Slide 25: Key Milestones
Key Milestones Event Status Raised $72.5M Series C-1, C-2 ✔ Awarded Orphan Drug Status: US/EU ✔ End of Phase 2 Meeting ✔ Initiate NEWTON in EU; close out activities in North America ✔ Raised $92.5 million in IPO ✔ Report full NEWTON dataset 1Q 2016 Initiate EG-1962 Pivotal Study Mid 2016 File IND fo
Slide 26: Key Investment Highlights
Key Investment Highlights Lead Candidate EG-1962 is Phase 3-ready; could replace standard of care in aSAHTargeted and sustained release of standard of care nimodipine NEWTON Phase 1/2 data shows dramatic 2x improvement in favorable outcomes Superior safety profileGranted Orphan Designation in US and
Slide 27: Edge Therapeutics, Inc.
Therapeutics, Inc. & EDGE” Therepeuties, he.
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