Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Edge Therapeutics — Investor Presentation (January 2018)
32 slides from Pds Biotechnology's investor presentation, Jan 8, 2018
Slide 1: Corporate Presentation January 2018
Corporate Presentation January 2018 ®
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: Strategy To Maximize Long-Term Value
Business development opportunities consistent with strategic focus Success of lead asset EG-1962 in aneurysmal subarachnoid hemorrhage (aSAH) via EVD Market expansion opportunities for EG-1962 Other routes of administration of EG-1962 for aSAH (Cisternal, Lumbar) Other indications in SAH (e.g. Non-a
Slide 4: Product Development Pipeline
Current Pipeline Product Candidate Formulation Development INDEnabling Phase 1 Aneurysmal Subarachnoid Hemorrhage Intraventricular (EVD) Delivery Intracisternal Administration Lumbar Administration Chronic Subdural Hematoma EG-1962 EG-1962 EG-1962 EG-1964 Phase 2 Phase 3 Product Development Pipeline
Slide 5: Recent and Expected Key Milestones
Recent and Expected Key Milestones 04 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 NEWTON 2 futility an
Slide 6: Aneurysmal Subarachnoid Hemorrhage (aSAH)
SAH (bleeding into subarachnoid space in the brain) is life-threatening with limited treatment options Aneurysmal SAH (aSAH), most severe form of SAH, is caused by a ruptured brain aneurysm Delayed cerebral ischemia (DCI) occurs days after SAH / aSAH; causes brain tissue death and is associated with
Slide 7: Current Management of aSAH
Only 17% of poorer grade patients (WFNS grades 2-4 with GOSE >6) return to favorable or normal status - sub-optimal nimodipine in the brain Current Management of aSAH Nimodipine (L-type Ca channel antagonist) is standard of care (SoC) to prevent DCI and improve outcomes, but prognosis is poor and co
Slide 8: EG-1962 Differentiation and Existing Data
EG-1962 Differentiation and Existing Data ®
Slide 9: EG-1962: Potential to Significantly Improve Outcomes, Safety and Convenience
EG-1962 provides sustained high drug exposure directly at the site of brain injury Ongoing Phase 3 study for aSAH (EVD) Positive Phase 2 (EVD) and preclinical results Potential for significant health economic impact Multiple Routes of Administration(EVD, Cisternal, Lumbar) EG-1962 EG-1962: Potential
Slide 10: NEWTON Study – Key Highlights
Maximum feasible dose identified (primary endpoint) 800 mg Positive safety and tolerability observed (secondary endpoint) NEWTON Study – Key Highlights 08 Phase 1/2, international, multi-center, randomized, controlled, open-label study All patients tolerated administration 73 patients completed (6 c
Slide 11: Pharmacokinetic Data Supports Clinical Benefit of EG-1962
EG-1962 achieved steady state sustained release of nimodipine 100x-1,000x higher nimodipine concentrations in CSF vs. oral nimodipine Pharmacokinetic Data Supports Clinical Benefit of EG-1962 09
Slide 12: EG-1962 Was Not Observed To 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 with oral nimodipine (n=0/54) 0.0% Hypotension 16.7% (n=3/18) EG-1962 Was Not Observed To Increase Risk of Hypotension EG-1962 Oral Nimodipine 10
Slide 13: NEWTON Study Suggested EG-1962 Potential to Improve Patient Outcomes
Glasgow Outcome Scale (GOSE) Unfavorable Outcome Favorable Outcome 1 2 6 3 4 5 7 8 Dead Vegetative State Lower Severe Disability Upper Severe Disability Lower Moderate Disability Upper Moderate Disability Lower Good Recovery Upper Good Recovery EG-1962 Cohorts 1-5(n=46) 59% Oral nimodipine(n=18) 28%
Slide 14: Additional Data from NEWTON Study Provides Further Rationale for Premium Pricing
(n=13/45) (n=11/18) 29% 61% (n=6/45) (n=6/18) 13% 33% (n=11/45) (n=10/18) 24% 56% EG-1962 Oral nimodipine Median (n=45) (n=18) Median 22.5 13.5 (n=45) (n=18) 10 12 14 16 18 20 22 24 26 28 17 25 12 VasospasmReduced by 52% DCIReduced by 61% Rescue Therapy Reduced by 57% ICU Length of Stay (LoS) Reduce
Slide 15: NEWTON 2 Phase 3 Study Replicates Major Elements of Phase 2 Protocol
NEWTON 2 Phase 3 Study Replicates Major Elements of Phase 2 Protocol 13 Comparing safety and efficacy of EG-1962 versus oral nimodipine 15 ~75 centers (North America, EU, Australasia)1 to 1 randomization; double-blind/double-dummyStratified by WFNS, Region Primary Endpoints Secondary & Health Econom
Slide 16: Potential Market Expansion Opportunity
Randomized, controlled, multi-center study 600 mg single injection Potential Market Expansion Opportunity 14 n=3 Phase 1/2 Cisternal Study 12 patients (3-1 randomization, EG-1962 vs oral nimodipine) Pharmacokinetics and safety study Key findings from interim data: EG-1962 cisternal delivery achieved
Slide 17: Market Access and Commercial Strategy
Market Access andCommercial Strategy ®
Slide 18: aSAH Among Most Expensive Diseases Treated in U.S. Hospitals
Average charge per aSAH patient is >$300,000 and >$400,000 with EVD, excluding physician fees* Physician related fees ICU and hospital stay Rescue therapy to treat delayed cerebral ischemia and vasospasm Mechanical ventilation Securing aneurysm (clip / coil) Primary drivers for charges+: aSAH Among
Slide 19: Reimbursement Overview for Hospital Care and aSAH
16 Reimbursement Overview for Hospital Care and aSAH Medicare(DRG) Fixed Rate(DRG/Per Diem) % Charges Fixed Rate(Capitation) Additional Payment Mechanisms:Stop-loss | Carve-out Note: In certain situations, contracts may preclude pharmacy charges from qualifying a case for payment under the stop-loss
Slide 20: Innovative Drugs Exist in the Hospital System
17 Product Indication Company Advancement to existing standard of care establishing new price to value potential Kymriah™ (tisagenlecleucel) B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse Novartis Premium pricing and NTAP reimbursement Defitelio
Slide 21: Independent Research: EG-1962 Pricing Flexibility and Access Supported by Payers
18 Independent Research: EG-1962 Pricing Flexibility and Access Supported by Payers Based on 10-15% Improvement vs. Standard of Care* “Good Value” / Not A Hurdle To Inclusion “Very Expensive” / Would Prompt Significant Discussion / Re-review “Expensive” / Would Prompt Discussion “Too Expensive” / Wo
Slide 22: Commercial Strategy
Commercial Strategy Strong relationships with key hospital decision makers North America:Small, targeted sales force of ~35 representatives Europe:Similar-sized sales force to NA ~300 hospitals accountfor 90% of all aSAH patients Drivers for rapid adoption (U.S. launch): EG-1962 administration
Slide 23: Four-Layered Approach to Maintain Barrier-to-Entry
Four-Layered Approach to Maintain Barrier-to-Entry 4 issued U.S. patents (including composition of matter to 2033), 32 issued foreign patents and more than 50 U.S. and foreign pending patent applications Intellectual Property Manufacturing know-how & trade secrets Precisa development platform Abilit
Slide 24: Precisa Development Platform
Precisa™ Development Platform Proprietary, programmable, biodegradable polymer-based development platform Controlled & Sustained Release Optimize product Program release profileSpecific blend of polymers Initial release profileSustained release profile Define product profileIdentify therapeuticEngin
Slide 25: EG-1962 Summary
EG-1962 Summary Pharmacokinetic rationale Improved outcomes vs nimodipine without off-target side effects in Phase 2 study; supports premium pricing rationale De-risked path to market High Barriers to Entry 22 Pivotal phase 3 design replicates key elements of phase 2 protocol 505(b)(2) regulatory pa
Slide 26: Questions?
Questions?
Slide 27: EG-1962: Favorable Outcomes in NEWTON Study by Cohort
Unfavorable Outcome Favorable Outcome 1 2 6 3 4 5 7 8 Dead Vegetative State Lower Severe Disability Upper Severe Disability Lower Moderate Disability Upper Moderate Disability Lower Good Recovery Upper Good Recovery EG-1962: Favorable Outcomes in NEWTON Study by Cohort 23 56% (n=5) 78% (n=7) 67% (n=
Slide 28: EG-1962: Clinical Benefit Observed Across Disease Severities
EG-1962: Clinical Benefit Observed Across Disease Severities 24 Overall: Over 2x improvement in favorable outcome rate WFNS 2 = Over 2x improvement in favorable outcome rate WFNS 4 = Nearly 2x improvement in favorable outcome rate
Slide 29: Negotiation Leverage for Carve Outs and Stop Loss Coverage
Negotiation Leverage for Carve Outs and Stop Loss Coverage 25 MORE NEGOTIATION LEVERAGE TO THE HOSPITAL MORE NEGOTIATION LEVERAGE TO THE PAYER Sole provider in geography / rural geographyProvider of specialized services (i.e. children’s hospital, trauma centers)Large teaching or academic center Paye
Slide 30: EG-1964 for cSDH
EG-1964 for cSDH 26 EG-1964 is a polymer-based therapeutic containing aprotinin for the management of cSDH as a prophylactic treatment to prevent recurrent bleeding If approved, we believe EG-1964 could address a significant unmet medical need and become the standard of care for treatment of cSDH in
Slide 31: Chronic Subdural Hematoma (cSDH) Overview
Chronic Subdural Hematoma (cSDH) Overview 27 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
Slide 32: January 2018
January 2018 (Nasdaq: EDGE) ®
Edge Therapeutics — Investor Presentation (January 2018) on 6ix