Exhibit 99.02
Seneca Biopharma (NASDAQ:SNCA) Partnering Opportunities for CNS Diseases
SUMMARY OF ASSETS AND OPPORTUNITY SEEKING PARTNERSHIP & BUSINESS DEVELOPMENT OPPORTUNITIES ALS & SCI S T RO K E ALLOGENEIC OFF THE SHELF CELL THERAPY CLINICAL STAGE: ALS and Chronic Stroke (Phase II), Spinal Cord Injury (Phase I) ASSETS: First - in - class stem cell - based treatments for neurological diseases 2
o Regeneration of damaged neural tissue SENECA BIOPHARMA: NEURAL STEM CELL PLATFORM & IP SUMMARY PRODUCT o Allogeneic human neural stem cells: long - lasting therapeutic, requires temporary immune suppression o Committed neural lineage; CNS restricted; differentiate into functional neurons and glia o Stable, off - the - shelf product & manufacturing is scalable for commercialization MECHANISM OF ACTION: Functional Integration Of Human Neural Cells Into Host CNS o Neurotrophic protection and support (A) Regeneration of tissue adjacent to infarct site at 24 months after transplantation in human stroke subjects (B) Graft - derived neurons integrate, extend axons and form synaptic connections with healthy host neurons in non - human primate model INTELLECTUAL PROPERTY: Approximately 50 Issued and Pending US and Foreign Patents Providing Broad Coverage o Use of human neural stem cells for treating neurodegenerative diseases o Exclusive licensee of patents covering devices used to administer the Company’s stem cell therapies o Neuronal bridge across damaged circuits 3
Indication Preclinical Phase I Phase II Phase III Amyotrophic Lateral Sclerosis (ALS) Chronic Ischemic Stroke Chronic Spinal Cord Injury FDA MEETING: March 2020 CONTROLLED STUDY READOUT: Q4 2020 PHASE I STUDY COMPLETED: Q4 2019 NSI - 566 PIPELINE: ALLOGENEIC, OFF - THE - SHELF CELL THERAPY: 3 CNS INDICATIONS CHRONIC ISCHEMIC STROKE: Phase I & II (n=31) — Phase I trial demonstrated safety and preliminary evidence of improvement in motor function from baseline levels o Placebo - controlled study in China scheduled to complete 3Q 2020 ALS: Phase I & II (n=30) — Demonstrated preliminary evidence of clinical benefit compared to historical controls o Pivotal study in the US in planning stages o FDA meeting March 2020 to get feedback on pivotal study design and development plan CHRONIC SPINAL CORD INJURY: Phase I (n=7) — Evidence of stable improvement in some subjects o Phase I completed Q4 2019 4
ISCHEMIC STROKE: MULTI - BILLION - DOLLAR GLOBAL OPPORTUNITY WITH FEW COMPETITORS ISCHEMIC STROKE OPPORTUNITY o Stroke is the most common cause of disability in the United States, most common cause of death in China (CN); ~75% of stroke cases are ischemic stroke o Estimated stroke survivor population of 7MM (US) and 80MM (global) o Prevalent cases will grow to 8 million in China over 10 yrs o No approved restorative therapy for chronic stroke and treatment is symptom management o Conservative estimate of US eligible patients is 175K with 10% market penetration (15 - 20,000 patients annually) o There are no late stage stem cell trials underway focused on chronic stroke o One of only two restorative interventional therapies targeting chronic ischemic stroke, and the only therapy shown to stably integrate into human CNS o Demonstrated preliminary evidence of tissue regeneration and ability to stably restore motor function in Phase I trial 5 o Phase I completed o NSI - 566 treated patients showed preliminary evidence of clinical benefit o Controlled Phase II study underway in CN, readout Q4 2020 o Tiered cell banks produced under cGMP, manufacturing process scalable for commercialization, sufficient material generated for treatment of >1M patients o Breakthrough Therapy designation application being considered o Seeking to sell assets, out - license, or forge global partnerships for development STAGE OF DEVELOPMENT PLAN NSI - 566 ATTRIBUTES
6 Zhang et al., 2019, Stem Cells Transl. Med. 8(10): 999 – 1007 Engraftment over 24 Months: NSI - 566 produce neurotrophic environment that regenerates tissue at infarct site BA SE L I NE 6 MONTHS 12 MONTHS 24 MONTHS ONE - TIME ADMINISTRATION OF 12 - 72 MILLION CELLS: o Direct injections into the lesion area of brain o 4 weeks of immunosuppression o Evidence of long - term graft survival/tissue regeneration (≥ 2 yrs) o Preliminary evidence of stable motor improvement NSI - 566 AND CHRONIC STROKE: PHASE I DATA AT 12/24 MONTHS
ALS: $1B+ OPPORTUNITY FOR NSI - 566 ALS OPPORTUNITY o 53,000 prevalent cases in seven major markets (US, 5EU, Japan) o 5,600 ALS patients newly diagnosed in United States annually o 50% increase in developing World expected 2015 - 2040 o Limited treatment options with poor efficacy o US NSI - 566 addressable market: ~65% of newly diagnosed patients o Pricing from $300K to $500K in the US, similar to launched cell therapies o Potential to be the first disease - modifying therapy in ALS based on preliminary efficacy observed in Phase I/II studies o Only cell therapy program in development that provides cells of neural lineage that stably integrate into the host spinal cord o Only program in development for ALS that is not a chronic therapy. Dose is one treatment and done. o Approval is possible based on successful outcome of a single registration trial o Pivotal study in the US planned, feedback from FDA expected in March/April 2020 on study design & development plan o Seeking to sell assets, out - license, or forge global partnerships for development PLAN NSI - 566 ATTRIBUTES o Multi - site open label Phase II study completed o NSI - 566 treated patients showed preliminary evidence of clinical benefit compared to matched historical controls o Tiered cell banks produced under cGMP, manufacturing process scalable for commercialization, sufficient material generated for treatment of >1M patients o Orphan drug designation granted for treatment of ALS o Type C meeting scheduled with FDA to obtain feedback on trial design and development plan STAGE OF DEVELOPMENT 7
o NSI - 566 treated patients showed preliminary evidence of clinical benefit compared to historical controls o Autopsies of deceased trial participants revealed persistent graft in all patients evaluated: up to 2.5 yrs. after treatment AND 1.75 yrs. after immunosuppression ended NSI - 566 AND ALS: EVIDENCE OF EFFICACY COMPARED TO HISTORICAL CONTROLS TRE A TED CONT R OL Time after implantation (months) Mean change in ALSFRS - R ALSFRS - R Scores: Phase I/II vs. Historical Controls 8 ALS PHASE I & II (AMBULATORY, NON - BULBAR PATIENTS): EDARAVONE IS THE ONLY FDA APPROVED TREATMENT FOR ALS IN THE PAST 20 YEARS: o Reduced decline of ALSFRS - R by 2.5 pts over 6 mo. o Multiple cycles of IV infusion required
CHRONIC SPINAL CORD INJURY: 3 RD INDICATION PRESENTS FURTHER UPSIDE POTENTIAL SCI OPPORTUNITY o 17K cases in United States annually and between 250K - 500K globally o Managed symptomatically, little to no spontaneous improvement after initial stage o No therapeutic to restore neurological function, few active stem cell trials focused on cSCI (no late stage studies) o Provides potential for restoring function in cSCI patients o NSI - 566, which already has orphan drug designation in ALS, has a potential for Breakthrough Therapy designation o Demonstrated evidence of tissue regeneration and opportunity to partially restore motor function in NHP model o Preclinical data indicate NSI - 566 cells form connections with host neurons and ‘bridge’ area of injury 9 o Phase I trial completed Q4 2019 o Therapy was well - tolerated o Treatment is safe, some subjects show evidence of improvement o Seeking to sell assets, out - license, or forge global partnerships for development STAGE OF DEVELOPMENT PLAN NSI - 566 ATTRIBUTES
10 NSI - 566 AND SCI: EFFECT OF NSI - 566 IN MONKEY MODEL AND POTENTIAL BENEFIT IN HUMANS Rosenzweig et al., 2018, Nat Med. 24(4): 484 - 490 o Graft - derived neurons integrate, extend long processes and form synaptic connections with healthy host neurons o Grafts confer improvement in motor function NSI - 566 HAS A RESTORATIVE EFFECT IN A PRIMATE MODEL OF SUBACUTE SCI: SUBJECT BASELINE 6 MONTHS 12 MONTHS 18 MONTHS 001 T8 T10 T10 T10 006 T7 - T7 T7 008 T2 - T2 - 010 T5 T6 T6 T6 NSI - 566 SHOWS POTENTIAL FOR CLINICAL BENEFIT IN PHASE I TRIALS: o 2 of 4 subjects in first cohort experienced stable improvements in neurological level of injury (ISNCSCI) o Improvement detected at 6 months after surgery, consistent with MOA (functional integration, formation of neuronal connections to bridge injury) Curtis et al., 2018, Cell Stem Cell 22(6): 941 - 950
KENNETH CARTER, PH.D. Executive Chairman o Led public and private biotechnology companies as CEO and/or Chairman o Co - founder of Avalon, Noble, NeoDiagnostics, NexImmune, Iterion, and others o Extensive early - stage drug development experience o CEO of Avalon Pharmaceuticals 10 years including IPO, and 5 years as NASDAQ company o Strong R&D partnership record with Merck, Novartis, Sanofi - Aventis, MedImmune and others o Broad network and advisory board service. National BIO Board, Maryland Healthcare Dev. Corp. o Adjunct faculty member at Johns Hopkins University MATTHEW KALNIK, PH.D. Senior Advisor o Seasoned executive with drug discovery, development, licensing, and M&A leadership experience o Held/holds senior roles at Pharmacia/Pfizer, Daiichi - Sankyo, Nabi, Antidote Therapeutics o Senior leader/executive experience at large, medium and small biopharma (public and private) o Former Pharmacia/Pfizer head of strategic in - licensing unit o Leadership roles in successful R&D product development o Closed over $1 billion of transactions with greater than $100 million of upfront payments o Founded Antidote Therapeutics, Inc. and created first - in - class pipeline of nicotine blockers DANE SAGLIO Acting CFO o Leadership experience in finance, accounting, strategic planning, and business for multiple biopharma companies o CFO of several private and public companies: CASI, Helomics, RegenRx, others o Extensive experience in fundraising and management ranging from early - stage entrepreneurial enterprises through mature public companies o Well known for building teams, setting goals, maintaining focus and the ability to make and implement decisions o Deep experience in securities transactions, SEC compliance, corporate governance DAVID RECKER, M.D. Chief Medical Officer o Has overseen clinical development at Seneca/Neuralstem since 2017 o Has led many US and global clinical trials for small molecules, biologics, and cell therapy o Former head of Clinical Sciences with Takeda's Global Research and Development division, former CMO at Vericel Corporation o Broad experience in clinical development, regulatory affairs, medical and scientific affairs, pharmacovigilance, statistics and data management o Has implemented global clinical development strategies for several pharmacologic agents in multiple therapeutic areas THOMAS HAZEL, PH.D. SVP, Research o Senior leadership positions within Seneca/Neuralstem for 15 years o Has led platform technology development, preclinical research efforts, and CMC initiatives for Seneca/Neuralstem in the US and its subsidiary in China o 25+ years of biopharma R&D experience o Extensive experience in technology transfer, translational research, and product development 11 SENECA MANAGEMENT TEAM
PROMISING PARTNERING OPPORTUNITY o First - in - class stem cell - based treatments for neurological diseases o Unmet medical needs in CNS diseases: ALS, chronic stroke, chronic spinal cord injury o Strong fundamental science and technology platform, significant development to date o Existing global academic partnerships & footprint o Several upcoming clinical milestones 12
TRANSACTION SUMMARY & TIMELINE SUMMARY o Initiating process for asset sale, out license, global development partnerships o Open to various structures: Investment, license/co - development, asset sale, or JV TIMELINE o Q1 2020: Initial outreach to interested parties and initial due diligence o Q2 2020: Completion of diligence and soliciting term sheets by end of Q2 o Q3 2020: Transaction close, beginning of technology transfer as appropriate 13
THANK YOU CONTACT INFORMATION: Kenneth Carter, PhD Executive Chairman k c arter @ senecabi o .com 14