Matinas Biopharma Holdings, Inc. · AMEX:MTNB
Matinas Biopharma — Technical Presentation (June 2017)
24 slides from Matinas Biopharma's technical presentation, Jun 5, 2017
Slide 1: MAT2203 - Interim Data from NIH Mucocutaneous Candidiasis Phase 2 Study
www.matinasbiopharma.com NYSE MKT: MTNB MAT2203 - Interim Data from NIH Mucocutaneous Candidiasis Phase 2 Study
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 st
Slide 3: Highlights
Highlights • Interim data from first two patients in National Institutes of Health (NIH) conducted Phase 2a study of MAT2203 for the treatment of refractory mucocutaneous candidiasis infection • Two out of two patients met the primary endpoint in achieving ≥ 50% clinical response • Patients reported
Slide 4: Background
Background • MAT2203: Novel encochleated formulation of a proven molecule, amphotericin B, a broad spectrum fungicidal agent - Novel oral delivery through nanoparticle formulation - Ability to convert an IV - only administered drug into an oral formulation - Early evidence of better tolerability wit
Slide 5: Collaboration with NIH
Collaboration with NIH • Collaboration with NIH began with IND enabling studies • NIH is conducting the study • Advanced Phase 2a study with enrollment and dosing of first two patients • Study subjects chosen because of inherent impaired immuno - compensation, long term fungal infection of over 20 y
Slide 6: Key Unmet Need Drivers
Key Unmet Need Drivers 1. Increasing resistance to presently available antifungal therapies 2. Increasing numbers of immunocompromised hosts/patients 6
Slide 7: Amphotericin B Value/Strengths and Limitations
Amphotericin B Value/Strengths of Amphotericin B • Amphotericin B is the most broad spectrum fungicidal agent • Gold standard of therapy for the treatment of all fungal infections • Little to no clinical resistance has developed in over 60 years of use Limitations of Amphotericin B • IV dosing • Tox
Slide 8: Refractory Mucocutaneous Candidiasis Infection in Hereditary Immunocompromised Patients
Refractory Mucocutaneous Candidiasis Infection in Hereditary Immunocompromised Patients • Autosomal Dominant Hyper IgE Syndrome (HIES or Job’s Syndrome) - HIES is a hereditary condition resulting in a weak immune system, involving STAT3 gene and resulting in IL - 17 and IL - 18 signaling deficiencie
Slide 9: Patients in Study Demonstrated Significant Resistance, Except to Amphotericin B
Patients in Study Demonstrated Significant Resistance, Except to Amphotericin B 9 Antifungal Agent Susceptibilities: Source Mouth Patient 01 Patient 02 Antifungal MIC (mcg/mL) Interpretation MIC (mcg/mL) Interpretation Amphotericin B 1 D1 1 D1 Anidulafungin 0.5 I <=0.015 S Caspofungin 2 R 0.03 S Flu
Slide 10: MAT2203 Phase 2a Study Protocol
MAT2203 Phase 2a Study Protocol • Open - label, dose - titration trial of MAT2203 (oral cochleate amphotericin B) • Evaluate up to 16 patients to determine the efficacy, safety, tolerability and pharmacokinetics of MAT2203 in treating recurring or refractory mucocutaneous candidiasis infections • Su
Slide 11: Interim Data - Safety Highlights
Interim Data - Safety Highlights • Oral treatment with MAT2203 for up to 54 days was well tolerated • No serious adverse events reported • Reported adverse events were mostly mild in severity and unrelated to MAT2203 • No signs of nephrotoxicity, hypokalemia or hepatoxicity (measured by ALT and AST)
Slide 12: Renal Safety Laboratory Parameters Over Weeks
Renal Safety Laboratory Parameters Over 8 Weeks 12 Indicators of Kidney Toxicity Remained Within Normal Limits Throughout 6 - 8 Week Treatment Period 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 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
Slide 13: Hepatic Safety Laboratory Parameters Over Weeks
Hepatic Safety Laboratory Parameters Over 8 Weeks 13 *Indicates normal range 0 10 20 30 40 50 60 Screening Day 14 Day 27 Day 41 Day 54 ALT (u/l) ALT (u/l) Patient 01 Patient 02 0 5 10 15 20 25 30 35 40 Screening Day 14 Day 27 Day 41 Day 54 AST (u/l) AST (u/l) Patient 01 Patient 02 Indicators of Live
Slide 14: Safety Summary - No Serious Adverse Events Reported
Safety Summary - No Serious Adverse Events Reported 14 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) Metabolism/nutritio
Slide 15: Interim Data - Efficacy Highlights
Interim Data - Efficacy Highlights • Two out of two patients achieved ≥ 50% subjective and objective clinical response - Both patients reported improved quality of life, e.g. able to eat a greater variety of foods, including those that are acidic and spicy • Two out of two patients achieved objectiv
Slide 16: Demonstrated a Meaningful Clinical Response
Demonstrated a Meaningful Clinical Response 16 - 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 Response) A
Slide 17: Patient Exam / Patient Quality of Life
Patient Exam / Patient Quality of Life • Patients reported improved quality of life, e.g. as able to eat a greater variety of foods, including those that are acidic and spicy • Both patients reported less pain 17 Baseline End of Treatment Patient 02 Patient 01
Slide 18: Fungal Culture Response
Pt. 01 Pt. 02 Baseline Day 14 Day 27 Day 41 Day 54 Legend: Fungal Culture Results Scale Moderate Moderate Moderate Moderate Scant Moderate No growth Moderate No growth Fungal Culture Response Heavy Moderate Light Scant 1 - Colony No growth 18
Slide 19: Interim Data Study Conclusion
Interim Data Study Conclusion • Two patients with AD - HIES or Job’s Syndrome with long - standing azole resistant mucocutaneous candidiasis responded clinically to oral treatment with MAT2203 • Oral treatment with MAT2203 for up to 54 days was well tolerated - Reported adverse events were mostly mi
Slide 20: Clinical Unmet Needs
Clinical Unmet Needs • Increasing resistance to presently available antifungal therapies • Increasing number of patients being rendered immunocompromised by advancements in medicine - NIH is in the vanguard of studying immunocompromised patients, the number of which is expected to increase due to th
Slide 21: MAT2203 Development Program and Next Steps
MAT2203 Development Program and Next Steps • Company takeaways - Response results likely predictive of study outcome - Safe long - term use supports development strategy towards preventative treatment • Second Phase 2 – next data readout: vulvovaginal candidiasis (VVC) – key objectives - With oral d
Slide 22: Prevention of Invasive Fungal Infections (IFI) Represents a Significant Market Opportunity
Prevention of Invasive Fungal Infections (IFI) Represents a Significant Market Opportunity 22
Slide 23: MAT2203: IFI Prevention is a Significant Value Driver
MAT2203: IFI Prevention is a Significant Value Driver • QIPD and Fast Track designations granted by FDA for MAT2203 - “Prevention of invasive fungal infections (IFI) due to immunosuppressive therapy” • Represents significant unmet clinical need - very few antifungals are approved for the preventativ
Slide 24: MAT2203 - Interim Data from NIH Mucocutaneous Candidiasis Phase 2 Study
www.matinasbiopharma.com NYSE MKT: MTNB MAT2203 - Interim Data from NIH Mucocutaneous Candidiasis Phase 2 Study
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