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NYSE AMER: MTNB September 2018 www.MatinasBioPharma.com MAT9001 OVERVIEW 1

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Page 1: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

NYSE AMER: MTNB

September 2018

www.MatinasBioPharma.com

MAT9001 OVERVIEW

1

Page 2: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

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

Page 3: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

HIGHtriglycerides

Pancreatitis

Cardiovascular Disease

Type 2 Diabetes

Fatty Liver Disease

HIGHrisk:

3

Page 4: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

HIGHnumber of patientswith high triglycerides

4

~4M ~65M(TG≥150mg/dl) (TG≥500mg/dl)

Page 5: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

Evidence & Experience:

Research shows strong evidence that Omega-3s lower triglyceride levels and reduce cardiovascular risk, but….

5

Page 6: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

Not all Omega-3s are the same:

Not all Rx Omega-3s

are the same:

6

COMMON OMEGA-3S

EPA

DHA is associated with an increase in LDL cholesterol

MTNB focus on UNIQUE OMEGA-3S

DHA

ALA ETA

HPA

LOVAZA(EPA and DHA)

EPANOVA(EPA and DHA)

VASCEPA(Pure EPA)

High DHA

Low DHA

DPA

SDA

Key Differentiation Driver for MTNB

Page 7: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

7

MAT9001A next generation

prescription-only

omega-3 fatty acid

medication

Page 8: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

MAT9001 has a unique composition as compared

to other Omega-3 products

LOVAZA EPANOVA

VASCEPAJust EPA

MAT9001EPA + DPA + HPA

Ethyl Ester Free Fatty Acid

Low

DHA

Mostly

EPA+DHAMix

MOLECULAR FORM

TYP

E O

F O

MEG

A-3

FA

8

Page 9: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

MAT9001 – Uniquely engineered Omega-3 composition

• Severe Hypertriglyceridemia

(≥500mg/dL)

• Highest potency

• Unique Mechanism of Action

• Trace amounts of DHA

9

EPA

SPECIFICALLY DESIGNED TO TREAT DYSLIPIDEMIA

DPA

Page 10: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

DPA provides potent fasting TG reduction in common

dyslipidemia animal model compared to EPA

10

FASTING TG REDUCTION IN “FATTY ZUCKER” RAT MODELTriglyceride Percent Reduction From Baseline – In Vivo (N=8 per treatment group)

-60%

-50%

-40%

-30%

-20%

-10%

0% 50 200 400 100 0

EPA

200 mg/kg

EPA

400* mg/kg

EPA

1000 mg/kg

DPA

50 mg/kg

Source: Matinas BioPharma research; unpublished

* Approximate equivalent to 4 grams/day in humans

Page 11: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

0

0.5

1

1.5

2

0 1 2 3 4 5

Olive Oil (OO)

OO + EPA 1 g/day

OO + DPA 1 g/day

0

0.2

0.4

0.6

0.8

1

0 1 2 3 4 5

DPA VERSUS EPA IN POSTPRANDIAL TG CONTROL IN HUMANSHuman Postprandial TG Levels (mmol/L) over 5 hours, after 7 days treatment (3-way cross-over, N=10)

Exploratory studies show potent DPA effects on human

postprandial triglyceride levels

11

* 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, 313-319

TG in Chylomicrons ++

TG in Total Plasma +

*

*

*

*

Page 12: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

Early data suggests synergy with statin usage

12

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

0

0.5

1

1.5

2

2.5

3

VehicleOnly

Vehicle +Statin

DPA +statin

0

0.5

1

1.5

2

2.5

3

VehicleOnly

Vehicle +Statin

DPA +statin

Source: Matinas BioPharma research; unpublished

PCSK9HMG-CoA Reductase

Relative mRNA expression levels in Rat liver after 4 weeks dosing (400 mg DPA/kg*day)

Page 13: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

MAT9001 Progress

13

✓ 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

Significant Achievements

✓ Established robust IP estate:

✓ Filed 22 patents across 3 families

✓ One U.S. Patent allowed Q4 2014

✓ Filed IND with FDA Q4 2014

✓ Completed first human study for MAT9001 versus Vascepain Canada Q2 2015

Page 14: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

Baseline Endpoint

MAT9001 – Comparative PK/PD Study Design

MAT9001

14 day treatment

4 capsules per day

Baseline

Screening &RandomizationTG 200-400 mg/dL

14

MAT9001

14 day treatment

4 capsules per day

Vascepa®

14 day treatment

4 capsules per day

Vascepa®

14 day treatment

4 capsules per day

5-week washout

5-week washout

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

42 Patients

Randomized

40 Patients

Completed

Page 15: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

MAT9001 – Top-Line Results Comparative PK/PD Study

15

-35%

-30%

-25%

-20%

-15%

-10%

-5%

0%

Triglyceride Reduction(Median % Change From Baseline)

P < 0.001

MAT9001

Vascepa®

-10.5 %

-33.2%

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

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MAT9001 PK/PD Efficacy Baseline Values

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MAT9001 Treatment Responses – Lipoprotein Lipids

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Treatment Responses – Apolipoproteins and PCSK9

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MAT9001 – Development Overview

MAT9001Next-generation, proprietary prescription-only omega-3 fatty acid

Specifically designed to

treat hypertriglyceridemia

and dyslipidemia

✓ Uniquely engineered Omega-3 composition✓ Severe Hypertriglyceridemia (≥500mg/dL)✓ DPA - Highest potency✓ DPA - Unique Mechanism of Action

DiscoveryIND

Preparation

Early Clinical

Development

Phase 3

Development

MAT9001

Development Status:• Filed IND with FDA in Q4 2014• 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

Not all Omega-3s are the same:DPA Differentiates MAT9001

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Page 20: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

MAT9001 Phase III for TG ≥ 500 mg/dL:Randomized phase plus 1-year extension @ 4 caps/day

20

MAT90012 caps/day

For 12 weeks

MAT90014 caps/day

For 12 weeks

Placebo4 caps/day

For 12 weeks

Randomize

Qualify Subjects withTG 500-2000 mg/dL

~90 subjects ~90 subjects

~90 subjects

~270 subjects

Page 21: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

Intellectual Property

21

Omega-3 Portfolio

▪ Filed 22 patents across 3 families

▪ One U.S. Patent issued Q4 2014 – US 8,906,964

Page 22: MAT9001 OVERVIEW - Amazon S3€¦ · 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin 0 0.5 1 1.5 2 2.5 3 Vehicle Only Vehicle + Statin DPA + statin Source: Matinas BioPharma

www.MatinasBioPharma.com

MAT9001 OVERVIEW

22

September 2018

NYSE AMER: MTNB