Matinas Biopharma Holdings, Inc. · AMEX:MTNB
Matinas Biopharma — Corporate Update (October 2016)
25 slides from Matinas Biopharma's corporate update, Oct 6, 2016
Slide 1: MAT2203 Clinical Development Update Call
www.matinasbiopharma.com OTCQB: MTNB TRANSFORMING THE WAY POTENT MEDICINES FOR INFECTIOUS DISEASES ARE DESIGNED MAT2203 CLINICAL DEVELOPMENT UPDATE CALL OCTOBER 6, 2016
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 19 95, including those relating to the Company's strategic focus and the future development of its product candidates, including MAT 220 3, the an
Slide 3: Agenda
Agenda 3 Forward Looking Statements / Introduction Jerry Jabbour President Peter Pappas, MD - UAB and President MSG Raphael Mannino, Ph.D., Chief Technology Officer Roelof Rongen CEO Douglas Kling - SVP Clinical Development Closing Remarks and Q&A
Slide 4: Agenda
Agenda 4 Forward Looking Statements / Introduction Jerry Jabbour President Peter Pappas, MD - UAB and President MSG Raphael Mannino, Ph.D., Chief Technology Officer Roelof Rongen CEO Douglas Kling - SVP Clinical Development Closing Remarks and Q&A
Slide 5: Risk of IFI in Patients with Hematologic Malignancy is Increasing and Mortality Rates are High
Risk of IFI in Patients with Hematologic Malignancy is Increasing and Mortality Rates are High • Increased risk is attributed to host defense impairment due to intensive cytotoxic chemotherapies, HSCT, ablative radiation therapy, use of corticosteroids, cyclosporine, and new immunosuppressive agents
Slide 6: Agenda
Agenda 6 Forward Looking Statements / Introduction Jerry Jabbour President Peter Pappas, MD - UAB and President MSG Raphael Mannino, Ph.D., Chief Technology Officer Roelof Rongen CEO Douglas Kling - SVP Clinical Development Closing Remarks and Q&A
Slide 7: Structure of Nanocochleate Formulations
Structure of Nanocochleate Formulations 7 Cargo Molecules Intercalate into the Phospholipid Bilayer Interior
Slide 8: Cochleate-Mediated Delivery into Activated Cells
Cochleate - Mediated Delivery into Activated Cells • Cochleates are actively taken up by activated cells such as infected macrophages and virus infected cells, resulting in delivery of cargo molecules directly into the interior of the cell • The normal low concentration of calcium within the cytopla
Slide 9: Cochleates Can Change the Pharmacokinetics and Biodistribution of Drugs
Cochleates Can Change the Pharmacokinetics and Biodistribution of Drugs 9 Macrophage Free Drug • Free drug in the extracellular milieu must cross the cell membrane in order to be effective against intracellular microorganisms. • High plasma and interstitial drug levels are needed. • A relatively low
Slide 10: Hyphen of the Alternaria Fungus Contain Rhodamine-Labeled Cochleates
The Hyphen of the Alternaria Fungus Contain Rhodamine - Labeled Cochleates Within 30 - minutes After Exposure 10 “ T rojan - H o rse” Ph e nome n on
Slide 11: Agenda
Agenda 11 Forward Looking Statements / Introduction Jerry Jabbour President Peter Pappas, MD - UAB and President MSG Raphael Mannino, Ph.D., Chief Technology Officer Roelof Rongen CEO Douglas Kling - SVP Clinical Development Closing Remarks and Q&A
Slide 12: MAT2203 Product Profile
MAT2203 Product Profile 12 Fungicidal; Broad Spectrum Few Drug – Drug Interactions Cochleate Benefits • Amphotericin B is perhaps the broadest spectrum antifungal agent • Amphotericin is not metabolized through typical liver pathways and does not experience the drug - drug interactions typically see
Slide 13: US Regulatory Environment Provides Solid Market Exclusivity Opportunity
13 Combined 12 - Year Exclusivity QIDP and Fast Track Designations to Date: • Treatment of Invasive Candidiasis • Treatment of Aspergillus • Prevention of IFI due to immunosuppressive therapy Orphan Drug Status: 7 Years Exclusivity QIDP: 5 Years Exclusivity US Regulatory Environment Provides Solid M
Slide 14: MAT2203 – IFI Prophylaxis is a Significant Value Driver
MAT2203 – IFI Prophylaxis is a Significant Value Driver • On September 7, 2016, MTNB announced FDA grant of QIPD and Fast Track designations for MAT2203 for: “Prevention of invasive fungal infections (IFI) due to immunosuppressive therapy” • Due to significant drug - drug interaction and lack of ora
Slide 15: MAT2203 – Development Foundation in Orphan Drug Territory
MAT2203 – Development Foundation in Orphan Drug Territory 15 Target Use: Candidiasis Aspergillosis IFI Prophylaxis Cryptococcal Meningitis x x x * x x x x x ** x *** Invasive Candidiasis in US: ~46,000 cases/year Invasive Aspergillosis in US: ~6,000 cases/year Stem cell: ~20,000; SOT: ~31,000 proced
Slide 16: Agenda
Agenda 16 Forward Looking Statements / Introduction Jerry Jabbour President Peter Pappas, MD - UAB and President MSG Raphael Mannino, Ph.D., Chief Technology Officer Roelof Rongen CEO Douglas Kling SVP Clinical Development Closing Remarks and Q&A
Slide 17: MAT2203 is Ideal Product for Prevention of Invasive Fungal Infections
MAT2203 is Ideal Product for Prevention of Invasive Fungal Infections in Patients Receiving Chemotherapy for Hematologic Malignancy 17 Feature Ideal Antifungal Agent for the Prevention of IFI Target Profile MAT2203 Safe/Well Tolerated x x Broad Spectrum Fungicidal Activity x x Convenient Oral Admini
Slide 18: Phase 2 Program to Support Phase 3 Development
Phase 2 Program to Support Phase 3 Development 18 Phase 2 program provide valuable milestones: ▪ Proof - of - concept for the cochleate lipid - crystal nano - particle technology platform ▪ Proof - of - concept for the MAT2203 as an antifungal agent in treatment of active fungal infections ▪ Clinica
Slide 19: Ongoing NIAID/Matinas Phase 2a Trial in Chronic Mucocutaneous Candidiasis
Ongoing NIAID/Matinas Phase 2a Trial in Patients with Chronic Mucocutaneous Candidiasis • Goal: Evaluate antifungal efficacy and safety with orally administered CAMB • Patients: Patients with diagnosis of persistent oropharyngeal (OPC), esophageal (EC), or vulvovaginal candidiasis (VVC) who are refr
Slide 20: Phase 2 Trial in Vulvovaginal Candidiasis (VVC)
Phase 2 Trial in Vulvovaginal Candidiasis (VVC) • Goal: Evaluate antifungal safety and efficacy with orally administered CAMB • Patients: Women with diagnosis of moderate to severe VVC (N=75) • Primary Objective: To evaluate the safety of oral CAMB 200 mg/day for 4 days • Secondary Objectives: - Cli
Slide 21: Phase Tolerability/PK in Hematologic Malignancy
Phase 2 Tolerability/PK in Hematologic Malignancy • Goal: Evaluate the multiple - dose tolerability and PK in patients with hematologic malignancy • Patients: Diagnosed with hematologic malignancy, entering first induction treatment or subsequent chemotherapy and expected to have preexisting or chem
Slide 22: Phase 3 Development Plans
Phase 3 Development Plans • Phase 3 study for the prevention of IFI in patients diagnosed with hematologic malignancy, entering first induction treatment or subsequent chemotherapy and expected to have preexisting or chemotherapy induced neutropenia - N = 400 - 500 patients - Double - blind control
Slide 23: Phase 3 Program to Provide Support of NDA Approval
Phase 3 Program to Provide Support of NDA Approval 23 Pivotal Phase 3 Study Phase 3 Studies Efficacy & Safety in patients treated with chemotherapy for hematologic malignancy Prevention Treatment Efficacy & Safety in patients with: • Candidiasis • Aspergillosis • Cryptococcal Meningitis One or more
Slide 24: Agenda
Agenda 24 Forward Looking Statements / Introduction Jerry Jabbour President Peter Pappas, MD - UAB and President MSG Raphael Mannino, Ph.D., Chief Technology Officer Roelof Rongen CEO Douglas Kling - SVP Clinical Development Closing Remarks and Q&A
Slide 25: MAT2203 Clinical Development Update Call
www.matinasbiopharma.com OTCQB: MTNB TRANSFORMING THE WAY POTENT MEDICINES FOR INFECTIOUS DISEASES ARE DESIGNED MAT2203 CLINICAL DEVELOPMENT UPDATE CALL OCTOBER 6, 2016
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