Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Edge Therapeutics — Investor Presentation (December 2017)
33 slides from Pds Biotechnology's investor presentation, Dec 13, 2017
Slide 1: December 2017 (Nasdaq: EDGE)
December 2017(Nasdaq: EDGE) ®
Slide 2: Disclaimer
Disclaimer This presentation and any statements of representatives of Edge related thereto that are not historical in nature (including but not limited to upcoming milestones) contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securiti
Slide 3: EDGE Therapeutics Overview
EDGE Therapeutics® Overview 3
Slide 4: Key Investment Highlights
Key Investment Highlights Phase 3 lead asset, EG-1962, supported by positive Phase 2 data and has potential to replace standard of care in aSAHAttractive commercial opportunity with high unmet needProprietary PRECISA™ technology: Platform to develop future productsBusiness development consistent wit
Slide 5: Product Development Pipeline
Product Development Pipeline 5
Slide 6: Near-term Catalysts
Near-term Catalysts Data readout from EG-1962 phase 3 NEWTON 2 pivotal studyTop-line data from full study in late-2018Futility analysis by end-2017Interim analysis in early-2018Submit investigational new drug (IND) application for second PRECISA product in 2018 6
Slide 7: Aneurysmal Subarachnoid Hemorrhage (aSAH)
Aneurysmal Subarachnoid Hemorrhage (aSAH) Ruptured brain aneurysm: bleeding into the subarachnoid space in the brainPatient Demographics85-90% of patients make it alive to the hospital83% of poorer grade patients die or suffer permanent brain damage within 90 days*Delayed complications occur in up t
Slide 8: Current Management of aSAH
Current Management of aSAH 8 Aneurysm RuptureExternal Ventricular Drain (EVD) ~50% of patients Universal administration of oral nimodipine (Class 1, Level A) Surgical / Endovascular Aneurysm Repair ICU Management(Watch & Wait) * Hänggi D, Etminan N, Macdonald RL, Steiger, HJ. NEWTON - Nimodipine mic
Slide 9: EG-1962 Differentiation and Existing Data
EG-1962 Differentiation and Existing Data 9
Slide 10: EG-1962 Value Hypothesis
EG-1962 Value Hypothesis Non-clinical studies and our Phase 2 NEWTON study support the proposition that EG-1962:Delivers 100 to 1,000 times the concentration of nimodipine directly to the brain with sustained delivery over 21 days vs. current standard of care oral nimodipineHas the potential to fund
Slide 11: EG-1962 Differentiation: Targeted Delivery of Nimodipine Directly into the Brain
EG-1962 Differentiation:Targeted Delivery of Nimodipine Directly into the Brain 11 Nimodipine PLGA EG-1962 Efficacy & Safety Nimodipine:dihydropyridine L-type Ca channel antagonist EG-1962: Targeted delivery achieves high brain concentration; yet safe plasma concentrationsDual mode of action from in
Slide 12: 12
12
Slide 13: Pharmacokinetic Data Supports Clinical Benefit of EG-1962
EG-1962 achieved steady state sustained release of nimodipine, and 100x-1,000x higher nimodipine concentrations in CSF vs. oral nimodipine Pharmacokinetic Data Supports Clinical Benefit of EG-1962
Slide 14: EG-1962 Did Not Increase Risk of Hypotension
Steady-state plasma concentration measured in EG-1962-treated patients was below 30 ng/ml, the level observed to cause systemic hypotension 16.7% Nimodipine EG-1962 Did Not Increase Risk of Hypotension
Slide 15: NEWTON Study – Key Highlights
Exploratory endpoints all favorable towards EG-1962 NEWTON Study – Key Highlights 73 patients completed (6 cohorts); 55 EG-1962, 18 oral nimodipineMaximum feasible dose identified (primary endpoint)800 mg All patients tolerated administration Safety & tolerability established (primary endpoint)PK ch
Slide 16: Over 2x Improvement in Favorable Outcomes in NEWTON Study
Dead Vegetative State Lower Severe Disability Upper Severe Disability Lower Moderate Disability 1 2 3 4 5 Unfavorable Outcome EG-1962 Clinical Effect: Over 2x Improvement in Favorable Outcomes in NEWTON Study 16 * Glasgow Outcome Scale (GOSE) Upper Moderate Disability Lower Good Recovery Upper Good
Slide 17: ~5x Improvement in GOSE Outcomes in NEWTON Study
GOSE 8 EG-1962 Clinical Effect: ~5x Improvement in GOSE 8 Outcomes in NEWTON Study 17 * Glasgow Outcome Scale (GOSE) Upper Moderate Disability Lower Good Recovery Upper Good Recovery 6 7 Favorable Outcome Oral nimodipine(n=18) EG-1962 Active Control Cohorts 1-5(n=46) 28% HistoricalData Dead Vegetati
Slide 18: NEWTON Health Economic Data Provides Rationale for Premium Pricing
NEWTON Study Health Economic Data Provides Strong Rationale for Premium Pricing 18 ICU LoS Reducedby 3.5 days (20%) Hospital LoS Reducedby 2.5 days (10%) Median ICU LoS Median Hospital LoS (n=45) (n=45) (n=18) (n=18) 13.5 17.0 22.5 25.0
Slide 19: NEWTON Study Reduced Cost Drivers for aSAH Patients
NEWTON Study Reduced Cost Drivers for aSAH Patients; Additional Rationale for Premium Pricing 19 Vasospasm Reduced by 52% EG-1962(n=45) Oral nimodipine(n=18) (n=13/45) (n=11/18) Rescue Therapy Reduced by 57% (n=11/45) (n=10/18) DCI Reduced by 61% (n=6/45) (n=6/18)
Slide 20: NEWTON 2 Pivotal Study Overview
NEWTON 2 Phase 3 Pivotal Study Overview 20 ~75 centers (North America, EU, Australasia)1 to 1 randomization; double-blind/double-dummyStratified by WFNS, Age, Region Primary Endpoints Secondary & Health Economic Endpoints Study Sample Size(n = 374) Neurological outcome measured at 90 days after aSAH
Slide 21: Potential Market Expansion: Phase 1/2 Cisternal Study
Potential Market Expansion Phase 1/2 Cisternal Study 21 Randomized, controlled, multi-center study600 mg as single injection12 patients (3-1 randomization, EG-1962 vs oral nimodipine)Pharmacokinetics and safety studyKey findings from interim data:EG-1962 cisternal delivery achieved steady state conc
Slide 22: Commercial Strategy
Commercial Strategy = ence!
Slide 23: aSAH Among Most Expensive Diseases Treated in U.S. Hospitals
aSAH Among Most Expensive Diseases Treated in U.S. Hospitals Commercial insurers are majority of payers for aSAHAverage age of aSAH patient = 52Average charge per patient for aSAH patient is >$300,000 and >$400,000 with EVD*Primary drivers for charges*: ICU and hospital stayRescue therapy to treat d
Slide 24: Commercial Strategy
Commercial Strategy Strong relationships with key hospital decision makers 24 North America:Small, targeted sales force of ~35 representatives Europe:Similar-sized sales force to NA~100 hospitals account for 90% of all aSAH patients in five largest European markets ~300 hospitals accountfor 90% of a
Slide 25: Three-Layered Approach to Maintain High Barrier-to-Entry
Three-Layered Approach to Maintain High Barrier-to-Entry 25 4 issued U.S. patents (including Composition of Matter), 12 issued foreign patents and more than 50 U.S. and foreign pending patent applications Intellectual Property Potentially difficult for competitors to prove bioequivalence (i.e., huma
Slide 26: The Future: PRECISA Development Platform
Controlled & Sustained Release The Future: PRECISA™ Development Platform 26 Proprietary, programmable, biodegradable polymer-based development platform Optimize product Program release profileSpecific blend of polymers Initial release profileSustained release profile Define product profileIdentify t
Slide 27: EG-1962 Summary
EG-1962 Summary Pharmacokinetic rationaleImproved outcomes vs nimodipine without off-target side effects in Phase 2 study; supports premium pricing rationaleDe-risked path to marketPivotal phase 3 design replicates key elements of phase 2 protocol505(b)(2) regulatory pathway allows for reduced devel
Slide 28: Recent and Expected Key Milestones
Recent and Expected Key Milestones 28 1H’17 2H’17 1H’18 Received pediatric waiver from EMA for EG-1962 Initiated study of EG-1962 cisternal delivery Secured $18M from RDO EG-1962 cisternal PK data update Entered into commercial supply agreement for EG-1962 Initiated EG-1962 lumbar PK animal study NE
Slide 29: EDGE Therapeutics
EDGE Therapeutics 29
Slide 30: EG-1962 Efficacy: Over 2x Improvement in Favorable Outcomes
Dead Vegetative State Lower Severe Disability Upper Severe Disability Lower Moderate Disability 1 2 3 4 5 Unfavorable Outcome 56% (n=5) 78% (n=7) 67% (n=6) 40% (n=4) 56% (n=5) Cohort 1 (100 mg; n=9) Oral nimodipine(n=18) Cohort 2(200 mg; n=9) Cohort 3(400 mg;n=9) Cohort 4(600 mg; n=10) Cohort 5(800
Slide 31: EG-1962 Efficacy: Clinical Benefit Noted With All Disease Severities
EG-1962 Efficacy: Clinical Benefit Noted With All Disease Severities 31 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
Slide 32: EG-1964 for cSDH
EG-1964 for cSDH Aprotinin: pancreatic trypsin inhibitor FDA approved in 1993 to prevent rebleeding following cardiac bypass surgeryMechanism of action potentially effective in reducing the incidence of rebleeding in cSDH patients 32 EG-1964 is a polymer-based therapeutic containing aprotinin for th
Slide 33: Chronic Subdural Hematoma (cSDH) Overview
Chronic Subdural Hematoma (cSDH) Overview 33 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 subdural spaceMost common in patient
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