Matinas Biopharma Holdings, Inc. · AMEX:MTNB
Matinas Biopharma — Canaccord Genuity 37th Annual Growth Conference (August 2017)
28 slides from Matinas Biopharma's conference presentation, Aug 10, 2017
Slide 1: Canaccord Genuity 37th Annual Growth Conference
www.matinasbiopharma.com NYSE MKT: MTNB Canaccord Genuity 37 th Annual Growth Conference Jerrome D. Jabbour, Co - founder and President
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains "forward - looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 , including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, cash flow and other s
Slide 3: Overview
Overview • Clinical - stage biopharmaceutical company focused on developing innovative anti - infectives for orphan indications • Flagship product, MAT2203 – orally - administered, encochleated amphotericin B, a broad spectrum fungicidal agent preparing to enter Phase 3 - Commencing tolerability/PK
Slide 4: Cochleate Technology Enables Targeted Oral Delivery of Potent Medicines
Cochleate Technology Enables Targeted Oral Delivery of Potent Medicines Low Calcium Environment 1 2 Cochleate opens up under low calcium environment and releases anti - infective into macrophage cell 3 Macrophage travels to infected tissues and delivers anti - infective Macrophage Cell Cochleate ent
Slide 5: MAT2203: C-Amphotericin B (CAmB)
MAT2203: C - Amphotericin B ( CAmB ) › Broad Spectrum Fungicidal - Amphotericin B is perhaps the broadest spectrum antifungal agent - Designated as QIDP with Fast Track Status for treatment of aspergillus, invasive candidiasis and prevention of invasive fungal infections › Few Drug – Drug Interactio
Slide 6: IFI Prevention Represents a Significant Market Opportunity
IFI Prevention Represents a Significant Market Opportunity 6 IFI Prevention:
Slide 7: MAT2203: Phase Program to Support Phase Development for IFI Prevention
MAT2203: Phase 2 Program to Support Phase 3 Development for IFI Prevention 7 Phase 2 Studies x Positive interim data reported x Demonstrated safe and efficacious long - term use of MAT2203 Mucocutaneous Candidiasis, up to N=16 Vulvovaginal Candidiasis N=75 x Study completed x Achieved primary endpoi
Slide 8: MAT2203 – Interim Data from NIH Mucocutaneous Candidiasis Phase 2 Study
MAT2203 – Interim Data from NIH Mucocutaneous Candidiasis Phase 2 Study • Two out of two patients met the primary endpoint in achieving ≥ 50% clinical response • Patients reported meaningful Quality of Life improvements - Able to eat a greater variety of foods, including those that are acidic and sp
Slide 9: MAT2203 Demonstrated a Meaningful Clinical Response
MAT2203 Demonstrated a Meaningful Clinical Response 9 - 42% - 42% - 57% - 57% - 14% - 57% - 85% -100% -90% -80% -70% -60% -50% -40% -30% -20% -10% 0% Baseline Day 14 Day 27 Day 40 Day 54 Clinical Response - Oropharyngeal Candidiasis Pt. 01 Pt. 02 Both Patients Met Primary Endpoint (≥50 Clinical Resp
Slide 10: Indicators of Renal and Hepatic Toxicity Remained Within Normal Limits
Indicators of Renal and Hepatic Toxicity Remained Within Normal Limits Throughout Treatment Period in NIH Study 10 * * * * * * * * 0 0.2 0.4 0.6 0.8 1 Screening Day 14 Day 27 Day 41 Day 54 Creatinine (mg/dl) Creatinine (mg/dl) Patient 01 Patient 02 0 1 2 3 4 5 Screening Day 14 Day 27 Day 41 Day 54 P
Slide 11: NIH Study Safety Summary – No Serious Adverse Events Reported
NIH Study Safety Summary – No Serious Adverse Events Reported 11 Incidence of Possible, Probably, or Definitely Related Treatment - Emergent Adverse Events by System Organ Class and Preferred Term System Organ Class MedDRA PT Relationship Grade CAmB N (%) Any subject with an AE Any 2 (100) Metabolis
Slide 12: Takeaways from Vulvovaginal Candidiasis (VVC) Phase 2 Study
Takeaways from Vulvovaginal Candidiasis (VVC) Phase 2 Study • VVC study chosen to further establish the safety and tolerability profile of MAT2203 while demonstrating efficacy through a mechanism involving systemic absorption • VVC provided increased patient exposure to expedite path toward a pivota
Slide 13: NIH and VVC Studies Significantly Strengthen MAT2203 Human Safety and PK Database
NIH and VVC Studies Significantly Strengthen MAT2203 Human Safety and PK Database • Current Database: • In the VVC study, MAT2203 impact on liver and kidney function in 91 patients exposed to MAT2203 - MAT2203 liver enzyme elevation in one patient was due to naproxen use, not an AE for MAT2203 - One
Slide 14: Substantial Reductions of Mean Composite Clinical Score in Both MAT2203 Treatment Arms
Substantial Reductions of Mean Composite Clinical Score in Both MAT2203 Treatment Arms 14 Mean Composite Clinical Score Over Time in VVC Study ( mITT population) 0 2 4 6 8 10 12 Baseline Day-5 TOC Day-12 200 mg/day CAMB 400 mg/day CAMB - 60.6% - 80.9% - 59.4% - 80.1%
Slide 15: Dose-Response Observed with MAT2203 in Phase 2 VVC Study
Dose - Response Observed with MAT2203 in Phase 2 VVC Study: Cl i nical C ure Ra t es at Day 12 TOC - visit 15 CA m B 2 0 0 m g /d a y CA m B 2 0 0 m g /d a y CA m B 4 0 0 m g /d a y CA m B 40 0 m g / d a y 57% 52% 52% 64% 55% 65% 0% 10% 20% 30% 40% 50% 60% 70% Diagnosed by KOH mITT Per Protocol CA m
Slide 16: Final Element of Phase 2 Program Toward IFI Prevention
Final Element of Phase 2 Program Toward IFI Prevention • Patients: Diagnosed with ALL or AML, entering first induction treatment or subsequent chemotherapy and expected to have preexisting or chemotherapy induced neutropenia (N=30) • Primary Objective: To establish maximum tolerable dose in patients
Slide 17: MAT2203: Phase 3 Program to Support NDA Approval
MAT2203: Phase 3 Program to Support NDA Approval 17 Pivotal Phase 3 Study • N = 400 - 500 patients • Double - blind control group • Primary Endpoint: Incidence of IFI • Secondary Endpoint: Safety Phase 3 Studies Efficacy & safety in patients treated with chemotherapy for Acute Lymphoblastic Leukemia
Slide 18: MAT2203 Development Roadmap
MAT2203 Development Roadmap 18 Study Q3 2016 Q4 2016 Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018 2019 Phase 2 NIH - Conducted Mucocutaneous Candidiasis (MC) Phase 2 NIH - Conducted Open Label Extension MC Phase 2 Vulvovaginal Candidiasis (VVC) FDA Type B Meeting: Discuss Data Pac
Slide 19: MAT2501: C-Amikacin
MAT2501: C - Amikacin › Broad Spectrum Aminoglycoside - Designated as QIDP and received Orphan Drug Designation for treatment of non - tuberculous mycobacterium (NTM) - Positive Phase 1 reported March 2017 › Potential Additional High - Need Indications - Cystic fibrosis associated lung infections -
Slide 20: MAT2501 Targeting NTM and Drug-Resistant Gram-Negative Bacterial Infections
MAT2501 Targeting NTM and Drug - Resistant Gram - Negative Bacterial Infections • MAT2501 formulates the broad - spectrum aminoglycoside amikacin into our lipid - crystal nano - particle cochleate technology • Active IND for the treatment of non - tuberculous mycobacterium (NTM) infections (environm
Slide 21: MAT2501 Positive Phase 1 Results
MAT2501 Positive Phase 1 Results • Single - ascending dose study in healthy volunteers (200, 400, 800mg) • Evaluated drug kinetics (blood, urine, feces), tolerability and acute safety • Peak blood levels were an area of focus; IV amikacin is known to generate high peak levels with potential kidney -
Slide 22: MAT2501 Has High Differentiation Potential in a Rapidly Evolving Anti-Infective Arena
MAT2501 Has High Differentiation Potential in a Rapidly Evolving Anti - Infective Arena 22 MAT2501 HAS THE POTENTIAL TO BE THE FIRST ORAL AMINOGLYCOSIDE Preclinical screening work in drug - resistant gram - negative infections: e.g. UTI, pneumonia, Acinetobacter, E. coli, Klebsiella NTM Infections:
Slide 23: MAT2501 Development Roadmap
MAT2501 Development Roadmap 23 Study Q4 2016 Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Phase 1 Single - Ascending Dose Phase 1 Multiple - Ascending Dose PK/Tolerability Phase 2 Non - Tuberculous Mycobacterium Positive Topline Results May 2017 Results Expected Q2 2018 Initiate H
Slide 24: Management Team and Board of Directors
Management Team and Board of Directors 24 Roelof Rongen Co - Founder, Chief Executive Officer, Director Jerome D. Jabbour, JD Co - Founder, President Raphael J. Mannino, PhD Chief Scientific Officer Dominick DiPaolo Senior Vice President of Quality and Regulatory Compliance Douglas F. Kling SVP, Cli
Slide 25: Prominent Clinical Advisors
Prominent Clinical Advisors 25 J. Carl Craft, MD - Chair • Former Chief Scientific Officer for Medicines for Malaria Venture (MMV) • Former Venture Head at Abbott Laboratories Anti - Infective Development Group Prof. Oliver Cornely , MD, FACP, FIDSA • Head of Translational Platform, Principal Invest
Slide 26: Financial Profile
Financial Profile 26 NYSE MKT MTNB Share Price $1.43 Market Cap ~$130 million 3 M Avg. Daily Vol. ~620,000 Shares Outstanding ~91 million As of August 8, 2017 Current cash on hand as well as cash potentially available through Controlled Equity Offering Sales Agreement will be suffici ent to meet ope
Slide 27: A Compelling Investment Opportunity
A Compelling Investment Opportunity x Data generated to date across all studies validates the delivery mechanism of action of drug delivery platform and warrants advancing MAT2203 into a Phase 3 registration study x Company engaging with FDA in Q4 2017 with the goal of moving MAT2203 into Phase 3 as
Slide 28: www.matinasbiopharma.com NYSE MKT: MTNB
www.matinasbiopharma.com NYSE MKT: MTNB Corporate Presentation August 2017
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