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8-K - FORM 8-K - PDS Biotechnology Corps001074x1_8k.htm
Exhibit 99.1
 
 October 2015 
 

 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, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. 
 

 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 fundamentally improve patient outcomes after Aneurysmal Subarachnoid Hemorrhage (aSAH). 
 

 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 EU; De-risked (505(b)(2)) regulatory pathwayAttractive commercial opportunity for EG-1962 in high unmet need600,000 aSAH patients WW; 35,000 patients in US annuallyConcentrated market: requires only small, highly focused sales force Compelling pharmacoeconomic benefitWholly owned - Worldwide rightsProprietary PRECISA™ Technology: Platform to develop future productsEG-1964 for cSDH and earlier stage discovery efforts ongoingStrong Financial PositionCash balance at June 30, 2015 was $58.5 million Raised approximately $92.5 million in IPO, which closed October 6, 2015 
 

 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 Macdonald, MD, PhD  Chief Scientific Officer, Co-founder, Director    Herbert Faleck, DO  Chief Medical Officer    Andrew J. Einhorn  Chief Financial Officer    Keenan Endowed Chair of Neurosurgery   20+ yearsInvestment Banking  Former CEO and Chairman  Pediatric Neurologist 
 

 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 annually in US)83% of poorer grade patients die or suffer permanent brain damage within 90 days*Delayed complications occur in up to 40% of patients who survive initial hemorrhage          aSAH Patients Annually600,000 Worldwide100,000 North America, EU, Japan    EG-1962 Market Expansion StrategyAlternative Delivery(Lumbar, Intracisternal)~50%17,500   EG-1962 Initial Market IndicationExternal Ventricular Drain (EVD)~50%17,500     Addressable US Population35,000 patients  Hospital AdmissionAneurysm Repair(endovascular or surgery)    * Hänggi D, Etminan N, Macdonald RL, Steiger, HJ. NEWTON - Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage. Neurocritical Care. Published Online: 13 February 2015. 
 

   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 patients return to favorable or normal status* Non-selective arterial dilation; systemic hypotension in up to 50% Short half life (45-minutes); requires heavy nursing burden; 2 pills every 4 hours x 21 days  –  –  –  Nimodipine        External Ventricular Drain (EVD) ~50% of patients  Universal administration of oral nimodipine (Class 1, Level A)  Aneurysm rupture  Stabilize patient  Surgical / endovascular aneurysm repair  ICU management (Watch & Wait)  7 | Confidential. Do not distribute.  * Hänggi D, Etminan N, Macdonald RL, Steiger, HJ. NEWTON - Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage. Neurocritical Care. Published Online: 13 February 2015. 
 

 EG-1962 Differentiation and Existing Data 
 

 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 heavy nursing burden; 2 pills every 4 hours x 21 days    EG-1962: Targeted delivery achieves high brain concentration; yet safe plasma concentrationsEG-1962: Dual mode of action from intravascular space and extravascular targets  Efficacy & Safety  +  Nimodipine - dihydropyridine L-type Ca channel antagonist  + 
 

 Key Clinical Scales  10 | Confidential. Do not distribute.  Enrollment  Outcome 
 

 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 dose (secondary endpoint)Exploratory endpoints all favorable towards EG-1962 
 

 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. Neurocritical Care. Published Online: 13 February 2015.  *  Patients Achieved GOSE 8EG-1962 27%Oral Nimodipine: 6%Historic Data: 1% 
 

 EG-1962 Efficacy: Outcome Improved Across All Doses   
 

 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 for Subarachnoid Hemorrhage. Based on Glasgow Coma Score and Motor Deficit.* Hänggi D, Etminan N, Macdonald RL, Steiger, HJ. NEWTON - Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage. Neurocritical Care. Published Online: 13 February 2015.  14 | Confidential. Do not distribute.  * 
 

 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 
 

 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 nimodipine  Cognitive assessment using the Montreal Cognitive Assessment (MoCA)ICU and Hospital Length of Stay; Discharge dispositionUse of rescue therapy  ~375 subjectsInterim analysis at 50-60% of planned enrollment  16 | Confidential. Do not distribute.  ~65 Centers (North America, EU, Australasia)1 to 1 randomization; double-blind/double-dummyStratified by WFNS, Age, Region  Study Design 
 

 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 properties  Identify unmetclinical condition  Targeted Delivery  Controlled & Sustained Release 
 

 Edge Pipeline Overview  18 | Confidential. Do not distribute. 
 

 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 potentially effective in reducing the incidence of rebleeding in cSDH patientsPlanned IND submission in 2016  If approved, we believe EG-1964 could address a significant unmet medical need and become the standard of care for treatment of cSDH in patients  (2) 
 

 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 subdural spaceMost common in patients aged 60+  Over time, the subdural hematoma expands by recurrent bleedingInitial treatment: Surgical intervention during which small holes are drilled in the skull to drain hematomaRebleeding: Occurs in up to 30% of cSDH patients and requires a repeat neurosurgical intervention 
 

 Commercial Opportunity  21 | Confidential. Do not distribute. 
 

 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 hospital decision makersAdministration of EG-1962 does not materially alter current physician behavior or treatment protocolPharmacoeconomic benefit: preventing complications saves hospitals and managed care organizations substantial costs, excluding outpatient rehabilitation / nursing home costs     
 

 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.; Allsbrook, Jennifer S.; Steele, Janet L.; Schulman, Kevin A.; Alexander, Michael J., Neurosurgery. 67(2):345-352, August 2010. 
 

 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 bioequivalence (i.e., human trial required)  Intellectual Property  Ability to prove bioequivalence  Manufacturing know- how & trade secrets  1.          2.                                  3.          Precisa development platform   
 

 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 for EG-1964 in Chronic SDH  2016 
 

 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 EU; De-risked (505(b)(2)) regulatory pathwayAttractive commercial opportunity for EG-1962 in high unmet need600,000 aSAH patients WW; 35,000 patients in US annuallyConcentrated market: requires only small, highly focused sales force Compelling pharmacoeconomic benefitWholly owned - Worldwide rightsProprietary PRECISA™ Technology: Platform to develop future productsEG-1964 for cSDH and earlier stage discovery efforts ongoingStrong Financial PositionCash balance at June 30, 2015 was $58.5 million Raised approximately $92.5 million in IPO, which closed October 6, 2015