Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Edge Therapeutics — Investor Presentation (February 2018)
30 slides from Pds Biotechnology's investor presentation, Feb 15, 2018
Slide 1: Corporate Presentation February 2018
Corporate Presentation February 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 EG-1962: Potential to Significantly Improve Outcomes, Safety and Convenience 07 Deli
Slide 10: NEWTON 2 Phase 3 Study Replicates Major Elements of Phase 2 Protocol
NEWTON 2 Phase 3 Study Replicates Major Elements of Phase 2 Protocol 08 Comparing safety and efficacy of EG-1962 versus oral nimodipine 10 ~75 centers (North America, EU, Australasia)1 to 1 randomization; double-blind/double-dummyStratified by WFNS, Region Primary Endpoints Secondary & Health Econom
Slide 11: NEWTON 2 Interim Analysis Possible Scenarios
NEWTON 2 Interim Analysis Possible Scenarios No formal futility analysis. However, DMC may recommend amending or terminating the study for safety concerns or based on a benefit:risk assessment that does not justify additional subject enrollment. 09 DMC may recommend stopping enrollment and waiting f
Slide 12: NEWTON Study – Key Highlights
Maximum feasible dose identified (primary endpoint) 800 mg Positive safety and tolerability observed (secondary endpoint) NEWTON Study – Key Highlights 10 Phase 1/2, international, multi-center, randomized, controlled, open-label study All patients tolerated administration 73 patients completed (6 c
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
EG-1962 Oral nimodipine 12 (n=13/45) (n=11/18) 29% 61% VasospasmReduced by 52% (n=6/45) (n=6/18) 13% 33% DCIReduced by 61% (n=11/45) (n=10/18) 24% 56% Rescue Therapy Reduced by 57% Median 13.5 (n=45) (n=18) 10 12 14 16 18 17 ICU Length of Stay (LoS) Reduced by 3.5 days (20%) (n=45) (n=18) Median 22.
Slide 15: Market Access and Commercial Strategy
Market Access andCommercial Strategy ®
Slide 16: 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 17: Reimbursement Overview for Hospital Care and aSAH
14 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 18: Independent Research: EG-1962 Pricing Flexibility and Access Supported by Payers
15 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 19: Innovative Drugs Exist in the Hospital System
16 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 20: 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 21: 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 22: 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 19 Pivotal phase 3 design replicates key elements of phase 2 protocol 505(b)(2) regulatory pa
Slide 23: Questions?
Questions?
Slide 24: 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 20
Slide 25: 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 21
Slide 26: 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 22 56% (n=5) 78% (n=7) 67% (n=
Slide 27: EG-1962: Clinical Benefit Observed Across Disease Severities
EG-1962: Clinical Benefit Observed Across Disease Severities 23 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 28: Negotiation Leverage for Carve Outs and Stop Loss Coverage
Negotiation Leverage for Carve Outs and Stop Loss Coverage 24 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 29: 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 30: February 2018
February 2018 (Nasdaq: EDGE) ®
Edge Therapeutics — Investor Presentation (February 2018) on 6ix