NYSE AMER: MTNB. MAT9001 OVERVIEW. September 2018

Transcription

1 NYSE AMER: MTNB MAT9001 OVERVIEW September

2 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 statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as expects, anticipates, intends, plans, could, believes, estimates and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under Risk Factors in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma s product candidates are all in a development stage and are not available for sale or use. 2

3 HIGH triglycerides HIGH risk: Pancreatitis Cardiovascular Disease Type 2 Diabetes Fatty Liver Disease 3

4 HIGH number of patients with high triglycerides ~65M (TG 150mg/dl) ~4M (TG 500mg/dl) 4

5 Evidence & Experience: Research shows strong evidence that Omega-3s lower triglyceride levels and reduce cardiovascular risk, but. 5

6 Not all Omega-3s are the same: COMMON OMEGA-3S Not all Rx Omega-3s are the same: EPA DHA High DHA LOVAZA (EPA and DHA) EPANOVA (EPA and DHA) MTNB focus on UNIQUE OMEGA-3S DHA is associated with an increase in LDL cholesterol ALA ETA SDA Low DHA HPA DPA VASCEPA (Pure EPA) Key Differentiation Driver for MTNB 6

7 MAT9001 A next generation prescription-only omega-3 fatty acid medication 7

8 MAT9001 has a unique composition as compared to other Omega-3 products TYPE OF OMEGA-3 FA Low DHA Mostly EPA+DHA Mix VASCEPA Just EPA LOVAZA Ethyl Ester MAT9001 EPA + DPA + HPA EPANOVA Free Fatty Acid MOLECULAR FORM 8

9 MAT9001 Uniquely engineered Omega-3 composition Severe Hypertriglyceridemia ( 500mg/dL) EPA DPA Highest potency Unique Mechanism of Action Trace amounts of DHA SPECIFICALLY DESIGNED TO TREAT DYSLIPIDEMIA 9

10 DPA provides potent fasting TG reduction in common dyslipidemia animal model compared to EPA FASTING TG REDUCTION IN FATTY ZUCKER RAT MODEL Triglyceride Percent Reduction From Baseline In Vivo (N=8 per treatment group) 0% DPA 50 mg/kg EPA 200 mg/kg EPA 400* mg/kg EPA 1000 mg/kg -10% -20% -30% -40% -50% -60% Source: Matinas BioPharma research; unpublished * Approximate equivalent to 4 grams/day in humans 10

11 Exploratory studies show potent DPA effects on human postprandial triglyceride levels DPA VERSUS EPA IN POSTPRANDIAL TG CONTROL IN HUMANS Human Postprandial TG Levels (mmol/l) over 5 hours, after 7 days treatment (3-way cross-over, N=10) 2 TG in Total Plasma + 1 TG in Chylomicrons * * * Olive Oil (OO) OO + EPA 1 g/day OO + DPA 1 g/day * * Significant difference from Olive Oil timepoint (p<0.05) + Significant AUC difference (p<0.1) OO vs. DPA ++ Significant AUC difference (p<0.05) OO vs. DPA Source: Linderborg et al.; PLEFA (2013) 88,

12 Early data suggests synergy with statin usage STATIN INDUCED GENE-EXPRESSION COMPENSATORY EFFECTS AND N-3 DOCOSAPENTAENOIC ACID (DPA) Relative levels of mrna for HMG-CoA Reductase and PCSK9 in Rat Liver In Vivo 3 HMG-CoA Reductase 3 PCSK Vehicle Only Vehicle + Statin DPA + statin 0 Vehicle Only Vehicle + Statin DPA + statin Relative mrna expression levels in Rat liver after 4 weeks dosing (400 mg DPA/kg*day) Source: Matinas BioPharma research; unpublished 12

13 MAT9001 Progress Significant Achievements Promising results with DPA in pre-clinical studies Proprietary process for high purity DPA manufacturing, at GMP 10+kg scale Development of proprietary soft-gel formulation Formation of high-powered Scientific Advisory Board Established robust IP estate: Filed 22 patents across 3 families One U.S. Patent allowed Q Filed IND with FDA Q Completed first human study for MAT9001 versus Vascepa in Canada Q

14 MAT9001 Comparative PK/PD Study Design MAT day treatment 4 capsules per day 5-week washout Vascepa 14 day treatment 4 capsules per day Screening & Randomization TG mg/dl 40 Patients Completed 42 Patients Randomized Vascepa 14 day treatment 4 capsules per day 5-week washout MAT day treatment 4 capsules per day Baseline Endpoint Baseline Endpoint Cross-over study design; each patient is its own control (high statistical power) Medication administered with food (life-style diet, as indicated) Patients resided in the clinic during treatment periods Steering Committee: Drs. CM Ballantyne, KC Maki, and WF Keane 14

15 MAT9001 Top-Line Results Comparative PK/PD Study 0% -5% -10% -15% -20% -25% -30% -35% Triglyceride Reduction (Median % Change From Baseline) MAT % Vascepa % P < Superior Bioavailability versus Vascepa (Primary Endpoint): approximately 6-fold higher AUC at high statistical significance Effects Other Lipid Parameters: MAT9001 better than Vascepa (P<0.05) VLDL-Cholesterol Non-HDL-Cholesterol Total Cholesterol PCSK9 (significant reduction with MAT9001, increase with Vascepa) MAT9001 similar to Vascepa (P=NS) LDL-cholesterol (both slightly reduced) HDL-cholesterol Detailed results expected to be presented at upcoming scientific congresses and in peer-reviewed journals over the course of the year 15

16 MAT9001 PK/PD Efficacy Baseline Values

17 MAT9001 Treatment Responses Lipoprotein Lipids

18 Treatment Responses Apolipoproteins and PCSK9

19 MAT9001 Development Overview MAT9001 Next-generation, proprietary prescriptiononly omega-3 fatty acid Not all Omega-3s are the same: DPA Differentiates MAT9001 Specifically designed to treat hypertriglyceridemia and dyslipidemia Uniquely engineered Omega-3 composition Severe Hypertriglyceridemia ( 500mg/dL) DPA - Highest potency DPA - Unique Mechanism of Action Discovery IND Preparation Early Clinical Development Phase 3 Development MAT9001 Development Status: Filed IND with FDA in Q Protocol responses to FDA (comparative PK and animal tox) Conduct trials upon FDA feedback FDA meeting and Phase 3 protocol review Comparative PK/PD crossover study completed results presented at NLA 2015 meeting 19

20 MAT9001 Phase III for TG 500 mg/dl: Randomized phase plus 1-year 4 caps/day Qualify Subjects with TG mg/dl ~270 subjects Placebo 4 caps/day For 12 weeks Randomize ~90 subjects ~90 subjects ~90 subjects MAT caps/day For 12 weeks MAT caps/day For 12 weeks 20

21 Intellectual Property Omega-3 Portfolio Filed 22 patents across 3 families One U.S. Patent issued Q US 8,906,964 21

22 NYSE AMER: MTNB MAT9001 OVERVIEW September