1. health and fitness
2. therapy

OTCQB: MTNB
www.MatinasBioPharma.com
Corporate Presentation
March 2015
1
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
MTNB Investment Highlights
•
MTNB is a publicly traded company with established value drivers and
infrastructure:
– Metabolic/cardiovascular lipid-based product development portfolio:
MAT9001 in clinical stage plus MAT8800
– Experienced management and board with strong development and
commercialization track record
•
Recently, MTNB acquired a novel lipid-crystal nano-particle drug delivery
technology comprising key clinical stage assets within the highly valuable
anti-infective space – Aquarius BioTech integration progressing rapidly
– Rapidly emerging drug-resistance creates urgent need for novel
anti-infective treatments
– MAT2203, Amphotericin B, a broad-spectrum fungicidal agent with no
clinical resistance reported to date – to enter Phase 2a study at NIH
– MAT2501, Amikacin, an aminoglycoside antibiotic for drug-resistant
gram-negative bacterial infections – in IND toxicology study stage
•
MTNB is at an inflection point with expected near-term progress on our
anti-infective programs plus a key data event for MAT9001 in 2Q 2015
3
Comps indicate that these new anti-infective programs
bring substantial value appreciation potential to MTNB
MTNB Programs
MAT2203
C-Amphotericin B
Fungal Infections
- To enter Phase 2a
COMPS
Raised $45 million
[Privately Held]
Amphotericin analogs
~$1.3 billion
[BSLN.SW]
~$2.1 billion
[ANAC]
Tavaborole
Topical Anti-Fungal
- Approved/Launched
Fungal Infections
- Discovery
Isavuconazole
Fungal Infections
- NDA Approved
~$1.0 billion
~$180 million
~$425 million
[INSM]
[AKAO]
[CTIX]
Inhaled Amikacin
Lung Infections
- Phase 3
Plazomicin
MDR Enterobact.
- Phase 3
Brilacidin
Skin Infections
- Phase 2
MAT2501
C-Amikacin
Gram-Negative
Bacterial Infections
- IND toxicology stage
4
Pipeline of Clinical-Stage Opportunities with
Potential to Drive Sustainable Value
Discovery
IND
Preparation
Early Clinical
Development
Phase 3
Development
Anti-Infective Development Programs
MAT2203
Fungal Infections
MAT2501
Gram-Negative Bacterial Infections
Metabolic/Cardiovascular Development Programs
MAT9001
Severe Hypertriglyceridemia
MAT8800
Fatty Liver Disease
5
Anti-Infective Development Programs
-- Broad-Spectrum Fungicidal Agent (MAT2203) --- Gram-Negative Aminoglycoside Antibiotic (MAT2501) -Proprietary Lipid-Crystal Nano-Particle
Cochleate Delivery Formulations
6
Antimicrobial Resistance is a Global Threat
“CDC sets threat levels for drug-resistant
'superbugs'”
“Superbugs to kill 'more than cancer' by 2050”
“WHO Calls for Action on Superbugs”
“CDC sounds alarm on deadly, untreatable
superbugs”
7
Drug-resistance threat has led to strong government
incentives and specific NIH support of MTNB technology
Anti-Infective Development Incentives
 Significant government funding
committed towards development of
new anti-infectives – i.e. $1.2 billion
in 2015, of which $650 million for
NIH
 New legislative initiatives to
stimulate anti-infective development:
– GAIN: Generating Antibiotic Incentives
Now – extra 5-year exclusivity
– ADAPT: Antibiotic Development to
Advance Patient Treatment
– DISARM: Developing an Innovative
Strategy for Antimicrobial Resistant
Microorganisms – improved
reimbursement
NIH Support Of MTNB Technology
 NIH interest driven by concerns over
drug-resistant infections
 NIH SBIR grants and research
contracts for development of:
– encochleated Amphotericin B, and
– encochleated Gram-negative
Aminoglycoside antibiotics
•
Amikacin
•
Capreomycin
 Discussion on Clinical Trial
Agreement with NIH for Phase 2a
clinical study with Amphotericin B in
patients near conclusion
8
Cochleate Technology Offers Significant Clinical
Improvement Potential
Multi-Organ Protection
• Cochleates act as a shield for the body from
otherwise toxic medicinal compounds
• Significantly reduces adverse effects
Targeted Delivery
• Cochleates are carried directly to infection sites
Oral Administration
• Oral administration of otherwise IV-only compounds
• Efficacy demonstrated in-vivo (animal studies)
• Tolerability demonstrated in Phase 1 human study
9
Cochleate Targeted Nano-Particle Delivery
Mitigates the Limitations of Potent Anti-Infectives
A platform drug delivery technology**…
1.
2.
3.
Reduces toxicity by containing drug
inside particle
Size and surface features facilitate
targeted delivery
Potential for oral administration
Calcium
PS* Bilayer
Drug
…that provides targeted delivery
1
High Calcium
Low Calcium
2
Nanocochleate particles
open up under low
calcium and deliver antiinfective intracellularly
50-500 nm
* Phosphatidylserine
** Cochleate Platform delivery technology under exclusive license from Rutgers University
10
Cochleate Nanoparticle Delivery has Broad Utility
with Potential for Orphan Drug Applications
Collaborations
Amphotericin B
Amikacin
In-Vitro
Animal POC
IND-Prep
Human Studies
NIH / PHRI
NIH
Vaccines
Ibuprofen
Atovaquone
NIH
Capreomycin
NIH
Meropenem
NIH
Anti-virals
NIH
Omega-3 FA
11
MAT2203
Amphotericin B Delivered in a Lipid-Crystal
Nano-Particle Cochleate Formulation
-- Broad-Spectrum Fungicidal Agent --
12
MAT2203 Represents Groundbreaking
Advancement in Anti-Fungal Treatment
•
No clinically observed drug resistance to Amphotericin B to date as opposed
to rapidly emerging drug resistance to azole and echinocandin anti-fungal
therapies – Unfortunately, the serious side-effects of Amphotericin B limit its
clinical use significantly
•
Amphotericin B is the only available broad-spectrum fungicidal agent, making
it the antifungal-of-choice for immuno-compromised patients
•
Disruptive technology: Oral delivery has significant advantages over current
IV-only administration of Amphotericin B
•
Demonstrated efficacy and little-to-no kidney toxicity in animal models as
compared to current Amphotericin B therapy
•
Differentiation supports potential to capture and expand $700 MM global
Amphotericin B market
•
Potential for Orphan Drug and Breakthrough Therapy designations
•
Encouraging efficacy and safety data supports advancing into Phase 2a
conducted at NIH at its expense – data expected by year-end
13
Anti-Fungal Market: Amphotericin B Use is Poised to Grow Due
to Increasing Rates of Azole and Echinocandin Resistance
MAT2203 Emerging Azole
Cochleate
& Candin
Formulation Resistance •
Growth
Drivers
•
Clinic / IV
Amphotericin for invasive fungal
and treatment resistant infections
in high-risk patients
Echinocandins for confirmed
candidiasis
Clinic / Outpatient
•
Amphotericin
Side Effects
•
Often initiated as an IV, then
transitioned to oral treatment
Typically voriconazole or
posaconazole
Outpatient Segment
•
•
High volume, low price: Typically
older first-line azole therapy
Predominantly fluconazole and
oral itraconazole
Amphotericin B
Current global market:
~ $700 million/yr
Current Products:
• Ambisome - Gilead
- Sales of ~ $365 MM
• Abelcet - Sigma-Tau
• Amphotec - Intermune
• Fungisome - Lifecare
• Fungizone - BMS
14
MAT2203 – Clinical Development Overview
Discovery
IND
Preparation
Early Clinical
Development
Phase 3
Development
MAT2203
Completed successfully a range of efficacy animal studies at NIH with C-Amphotericin B
 Preparing 2a efficacy trial at NIH – refractory mucocutaneous candidiasis patients
 Increasing C-Amphotericin B scale to ~800 doses/batch
 Single-Dose Phase 1 study completed with favorable tolerability
Next Steps:
 Patient treatment protocol under development in collaboration with NIH/NIAID
 Phase 2a study expected to commence at NIH in 2Q 2015
 To engage with FDA on development program post-Phase 2a data

15
MAT2501
Amikacin Delivered in a Lipid-Crystal NanoParticle Cochleate Formulation
-- Gram-Negative Aminoglycoside Antibiotic --
16
Antibiotic-resistant and serious gram-negative bacterial
infections provide a significant market opportunity
Gram Negative Resistant Infections, CDC report 2013
- 725,000/year (US only) DR-Enterobacter
DR-Shigella
(CRE & ESBL)
DRMDRSalmonella
Pseudomonas
DRNeisseria
Gonorrheae
DR-Campylobacter
Other Serious Gram-Negative Infections:
(US Only – Cases Annually)
- Pneumonia in Cystic Fibrosis (CF)
- 30,000 CF patients
- Ventilator Associated Pneumonia (VAP)
- More than 70,000 VAP cases
- Neutropenic Fever in Leukemia
- More than 15,000 cases
- Neutropenic Fever in Transplant
- More than 10,000 cases
- Tuberculosis
- About 10,000 cases
- Non-Tuberculous Mycobacterium (NTM)
- More than 12,000 cases
Sources: CDC Antibiotic Resistance Threats, 2013 MDR-Acinetobacter
CDC, Navigant, NTM Info & Research, AAST, NIH
Key:
DR – Drug-Resistant
MDR – Multi-Drug-Resistant
17
MAT2501 – Development Overview
MAT2501
C-Amikacin
Treating severe and hospital-acquired gramnegative bacterial infections
Potential High-need Indications:
• Cystic Fibrosis pulmonary infections
Potential to be first orally administered
• Ventilated patients in ICU or long-term care
Amikacin without toxicity or side
• Hospital acquired urinary track infections
effects as seen with IV
Discovery
MAT2501
IND
Preparation
Early Clinical
Development
Phase 3
Development
 Completed proof-of-principle testing in
animal models showing in vivo efficacy of
oral C-Amikacin (M. Avium)
Next Steps:
• Formal Pre-Clinical Animal Toxicology
Studies Ongoing at NIH
• IND filing expected late 2015
18
Metabolic / Cardiovascular
Development Programs
-- MAT9001 --- MAT8800 --
19
MAT9001 – Clinical Development Overview
Specifically designed to
treat hypertriglyceridemia
and dyslipidemia
MAT9001
Next-generation,
proprietary prescriptiononly omega-3 fatty acid
Not all Omega-3s are the same:
DPA Differentiates MAT9001
Discovery




Uniquely engineered Omega-3 composition
Severe Hypertriglyceridemia (≥500mg/dL)
DPA - Highest potency
DPA - Unique Mechanism of Action
IND
Preparation
Early Clinical
Development
Phase 3
Development
MAT9001
Development Status:
• Filed IND with FDA in Q4 2014
• Comparative PK/PD crossover study ongoing in Canada – ~50 pts
20
MAT8800 – Development Overview
MAT8800
Treating Fatty Liver Disease
Proprietary Omega-3
Discovery Program
Unique approach with omega-3
composition; differentiated from the
bile-acid approach
Discovery
NAFLD
NASH
• Common:
12% of U.S.
population
• A leading cause
of cirrhosis
IND
Preparation
• NO APPROVED
TREATMENT OPTION
Early Clinical
Development
Phase 3
Development
MAT8800
Development Status :
• Animal studies ongoing to support composition
selection and further optimization
21
Comps for the MTNB Metabolic/Cardiovascular
Disease programs indicate substantial value
MTNB Programs
MAT9001
EPA/DPA
Severe HTG
- Clinical Pre-Phase 3
COMPS
~$50 million
~$325 million
$323 million
[ACST]
EPA/DHA from Krill
[AMRN]
[sold to AZN]
Severe HTG
- Clinical Pre-Phase 3
EPA only
Severe HTG
- Approved/Launched
EPA/DHA
Severe THG
- Approved
~$80 million
~$100 million
~$?? million
[GALT]
[GLMD]
[RGDO merger]
GR-MD-02
NAFLD / NASH
- Phase 1 completed
Aramchol
NAFLD / NASH
- Phase 2b
Cenicriviroc
NAFLD / NASH
- Phase 2
MAT8800
Omega-3 composition
NAFLD / NASH
- Discovery
22
Intellectual Property
Cochleate Lipid Delivery Portfolio – Exclusive License Rutgers University
 17 issued U.S. and foreign patents
- 10 patents issued within past 3 years; Patent protection currently extends through 2027
 Over 20 pending U.S. and foreign patent applications
- 16 national phase applications filed within past 2 years based on: PCT/US2012/036576 and
PCT/US2013/052756 ; Pending applications can extend patent protection through 2033
- Active research pipeline for new patent applications
 Portfolio covers wide spectrum of cochleate technology, including:
-
Cochleates and methods of delivering biologically relevant molecules to a host (2 issued patents)
Vaccine compositions and protein-lipid vesicles (2 issued patents)
Method making cochleates using aqueous solution containing detergent + lipid mixture (1 issued patent)
Small interfering RNA cochleates (3 issued patents and 1 pending application)
Geodate cohcleates (8 issued patents and 1 pending application)
Amphotericin B cochleates (1 issued patent and 1 pending application)
Methods of enhancing the encochleation of hydrophilic molecules (5 pending applications)
Cochleates made with low purity soy phosphatidylserine (13 pending applications as of 2/28/15)
Omega-3 Portfolio
 Filed 22 patents across 3 families
 One U.S. Patent issued Q4 2014 – US 8,906,964
23
Experienced Management Team and Board
Strong development and commercialization track record
Roelof Rongen
– President and CEO, Director
George Bobotas, PhD
– Chief Scientific Officer
Jerome Jabbour, JD
– Chief Business Officer & General Counsel
Abdel Fawzy, PhD
– EVP Pharmaceutical & Supply Chain Dev.
Gary Gaglione, CPA
– VP Finance, Acting CFO
Herbert Conrad, Chairman BOD
– Roche, Pharmasset, Celldex, Reliant, Dura, Bone Care
James Scibetta, Director
– CFO Pacira, Bioenvision/Genzyme, Merrimack
Stefano Ferrari, Director
– ProSPA, Bioseutica, KD-Pharma
Adam Stern, Director
– CEO SternAegis Ventures
24
Prominent Scientific Advisory Board
Anti-Infectives
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
Raphael Mannino, PhD
– Associate Professor of Pathology and Laboratory Medicine at Rutgers
University, New Jersey Medical School. Founder, former President, CEO, CSO
and EVP of BioDelivery Sciences, Inc [BDSI].
Dyslipidemia & Cardiovascular Diseases
Christie M. Ballantyne, MD, PhD, FACC, FNLA
– Baylor College of Medicine, Center for Cardiovascular Disease Prevention at
the Methodist DeBakey Heart and Vascular Center, Lipid Metabolism and
Atherosclerosis Clinic at Houston Methodist Hospital
Kevin Maki, PhD, FNLA
– DePaul University, Midwest Center for Metabolic & Cardiovascular Research,
Great Lakes Clinical Trials, National Lipid Association’s Expert Panel
25
Matinas BioPharma – Financial Snapshot
OTCQB
MTNB
Share Price
$0.52
Market Cap
~$20 million
Shares Outstanding
~37 million
As of March 10, 2015
26
MTNB – A Compelling Investment Opportunity
•
MTNB is a publicly traded company with established value drivers and
infrastructure:
– Metabolic/cardiovascular lipid-based product development portfolio:
MAT9001 in clinical stage plus MAT8800
– Experienced management and board with strong development and
commercialization track record
•
Recently, MTNB acquired a novel lipid-crystal nano-particle drug delivery
technology comprising key clinical stage assets within the highly valuable
anti-infective space – Aquarius BioTech integration progressing rapidly
– Rapidly emerging drug-resistance creates urgent need for novel
anti-infective treatments
– MAT2203, Amphotericin B, a broad-spectrum fungicidal agent with no
clinical resistance reported to date – to enter Phase 2a study at NIH
– MAT2501, Amikacin, an aminoglycoside antibiotic for drug-resistant
gram-negative bacterial infections – in IND toxicology study stage
•
MTNB is at an inflection point with expected near term progress on our
anti-infective programs plus a key data event for MAT9001 in 2Q 2015
27
OTCQB: MTNB
www.MatinasBioPharma.com
Company Presentation
March 2015
28