UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 10, 2016
MEDICINOVA, INC.
(Exact name of registrant as specified in its charter)
| DELAWARE | 001-33185 | 33-0927979 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| 4275 EXECUTIVE SQUARE, SUITE 650, LA JOLLA, CA |
92037 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: (858) 373-1500
Not applicable.
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 7.01 | Regulation FD Disclosure. |
On November 10, 2016, MediciNova, Inc. (the “Company”) updated the slide presentation to be used by the Company at investor meetings. A copy of the revised slide presentation is furnished as Exhibit 99.1 and is incorporated herein by reference. The Company does not undertake to update this presentation.
The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities under that Section, nor be deemed to be incorporated by reference into the filings of the registrant under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Slide presentation of the Company. | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MEDICINOVA, INC. | ||
| By: | /s/ Yuichi Iwaki | |
| Yuichi Iwaki, M.D., Ph.D. Chief Executive Officer | ||
Date: November 10, 2016
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Slide presentation of the Company. | |
| Exhibit 99.1
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Corporate Presentation
November 2016
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Forward-Looking Statements
Statements in this presentation that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding MediciNova’s clinical trials supporting the safety and efficacy of its product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for clinical trials and product development, strategies, future performance, expectations, assumptions, financial condition, liquidity and capital resources. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-221, MN-001, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “estimates,” “projects,” “can,” “could,” “may,” “will,” “would,” “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-221, MN-001, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova’s operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks (including reliance on a joint venture entity in China to develop and commercialize MediciNova’s product candidates in China), risks related to MediciNova’s reliance on the success of its MN-166 and MN-001 product candidates, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and MediciNova’s ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2015 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of November 10, 2016. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.
2 © 2016 MediciNova, Inc.
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MediciNova Overview
MediciNova, Inc. is a publicly-traded, development-stage biopharmaceutical company focused on acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs.
Headquarters La Jolla, California
Dual-Listed Listed in both the U.S. and Japan
NASDAQ: MNOV
TSE - JASDAQ: 4875
No. of Employees 10
7 in US
3 in Japan
3 © 2016 MediciNova, Inc.
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Investment Highlights
Novel product candidates in Phase 2 clinical development with encouraging efficacy and safety data
MN-166 (ibudilast)
MN-001 (tipelukast)
Treatment of Neurological Diseases i.e. Progressive MS, ALS, and Substance Dependence
Approved in Japan in 1989
- post-stroke dizziness and asthma
Large safety database
Treatment of Fibrotic Diseases i.e. IPF (idiopathic pulmonary fibrosis)
Treatment of Hyperlipidemia and Fibrotic Disease i.e. NASH (nonalcoholic steatohepatitis) and NAFLD (nonalcoholic fatty liver disease)
Well capitalized
Experienced management team
4 © 2016 MediciNova, Inc.
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Programs in Clinical Development
Core programs/ Indications Status Preclinical Phase 1 Phase 2 Phase 3
MN-166, Oral Anti-Inflammatory / Neuroprotective Therapeutic
NEURODEGENERATIVE DISEASES
Progressive Multiple Sclerosis
FAST TRACK Ongoing: Fully Enrolled in Q2-2015
NeuroNEXT / Cleveland Clinic (Funded by NINDS)
ALS (Amyotrophic Lateral Sclerosis)
Carolinas Neuromuscular / ALS-MDA Center Ongoing
FAST TRACK
ALS / Biomarker
Massachusetts General Hospital (MGH) Ongoing
SUBSTANCE DEPENDENCE
Methamphetamine Dependence
UCLA (Funded by NIDA) FAST TRACK Ongoing Opioid Dependence
Completed Phase 2 trial
Columbia University (Funded by NIDA)
Alcohol Dependence
UCLA (Funded by NIAAA) Completed Phase 2 trial
MN-001, Oral Anti-Inflammatory / Anti-Fibrotic Therapeutic
NASH (Nonalcoholic Steatohepatitis) FAST TRACK Ongoing
IPF (Idiopathic Pulmonary Fibrosis) FAST TRACK Ongoing
Orphan Drug
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Developing Novel Therapeutics…
MN-166 MN-001
Ibudilast Tipelukast
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How does MN-166 work? MN-166 Ibudilast
MIF Inhibition
Linked to attenuated disease progression in animal models of MS
PDE 4 Inhibition
Increases cAMP
Reduces pro-inflammatory cytokines (i.e. IL-1, TNF-?, IL-6)
Neuroprotection
GLIAL CELL ATTENUATION
Role of Glia:
– Type of macrophage
– Activated during brain damage
– Glial activation leads to neurodegeneration
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Progressive Multiple Sclerosis (MS)
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Progressive Multiple Sclerosis (MS)
MS AFFECTS 2.3M+ Worldwide1 400,000+ In United States1
DIMINISHED QUALITY OF LIFE (e.g. fatigue, walking difficulties, weakness, pain, cognitive changes, depression)1
EXPECTED MARKET OPPORTUNITY* $ 19B+ Worldwide (*Total sales of RRMS drugs were >$19B in 2015. We believe Progressive MS market is at least as large as RRMS market.)
NO APPROVED DRUGS For long-term treatment of Progressive MS
1. Source: National Multiple Sclerosis Society
9 © 2016 MediciNova, Inc.
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MN-166 Phase 2 Relapsing MS Trial Completed MN-166 Ibudilast
Trial Design and Results
Trial Design:
N = 297 subjects with relapsing multiple sclerosis (MS)
Multi-arm (30 mg/day, 60 mg/day, placebo) randomized 1:1:1, 12-months of double-blind treatment, followed by 12 months of extension during which placebo subjects were switched to MN-166
Multicenter, 24-month study, with interim 12-month efficacy analyses
Results:
SAFETY: 82% completed the full 24 month study; AEs related to mild, self-limiting GI
EFFICACY:
Did not meet efficacy endpoint of MRI lesion count*, which reflects markers of RRMS
Hit important neuroprotective endpoints related to disease progression
- Sustained disability progression was significantly less likely
- Significant reduction of brain volume loss
- Significant reduction of conversion of acute lesions to persistent black holes
* Cumulative number of active (gadolinium (Gd)-enhancing (T1) and nonenhancing new/enlarging (T2) cranial Magnetic Resonance Imagining (MRI) lesions
10 © 2016 MediciNova, Inc.
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MN-166 Phase 2 Relapsing MS Trial
Disability Progression Data: 24 Months MN-166 Ibudilast
MN-166 Reduced Disability Progression* by 50%
21.0% p=0.026
10.4%
N = 100 N = 192
Placebo to MN-166 MN-166 (two years)
* Proportion of subjects with disability progression (sustained change in EDSS ?1 point higher than baseline over a period of at least four consecutive months)
11 © 2016 MediciNova, Inc.
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MN-166 Phase 2 Relapsing MS Trial
Brain Volume Data: 12 Months MN-166 Ibudilast
MN-166 Reduced Brain Volume Loss
0.00%
Placebo MN-166
-0.20%
60 mg
-0.40%
-0.60%
-0.80% N = 98
-0.82%
-1.00%
N = 100
-1.20% p=0.035
-1.17%
-1.40%
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MN-166 Phase 2b Progressive MS Trial Ongoing MN-166 Ibudilast
SPRINT-MS: Phase 2b Trial in Progressive MS (Ongoing)
FUNDING
PRIORITY
PRINCIPAL INVESTIGATOR
CLINICAL COORDINATING CENTER
DATA COORDINATING CENTER
SITES
ADDITIONAL FUNDING
Funded by NIH grant through NINDS
Ibudilast was the first drug chosen by NINDS for an interventional clinical trial in the NeuroNEXT program
Robert Fox, M.D. Cleveland Clinic
Massachusetts General Hospital
University of Iowa
28 academic medical centers in the NeuroNEXT network
National Multiple Sclerosis Society provides patient advocate input and trial enrollment awareness and has provided additional funding
13 © 2016 MediciNova, Inc.
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MN-166 Ibudilast
MN-166 Phase 2b Progressive MS Trial Ongoing
SPRINT-MS: Trial Design
N = 255 subjects with Primary or Secondary Progressive MS (PPMS or SPMS)
Interferon-beta or glatiramer acetate are allowed as concomitant medication
Phase 2b randomized, double-blind trial; 96-weeks; 28 centers in the U.S. (NeuroNEXT sites)
Dosing: up to 100 mg/day (50 mg BID) of MN-166 (ibudilast) or placebo (1:1 randomization)
Primary: whole brain atrophy using brain parenchymal fraction (BPF); safety and tolerability
Secondary: disability, imaging analyses of brain and retinal tissue integrity, cortical atrophy, cognitive impairment, quality-of-life, and neuropathic pain
Enrollment completed; Interim Analysis in Q4 2016;
Final results expected in 2017, assuming trial continues after Interim Analysis
© 2016 MediciNova, Inc.
TRIAL DESIGN
OBJECTIVES
STATUS
14
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MN-166 Ibudilast
MN-166 Phase 2b Progressive MS Ibudilast Trial Sites Ongoing
Albert Einstein College of Medicine University of California - Davis Brigham and Women’s Hospital University of California - Los Angeles Cleveland Clinic University of Cincinnati Columbia University Medical Center University of Colorado – Denver Emory University University of Kansas Medical Center Massachusetts General Hospital University of Miami School of Medicine Northwestern University University of Pittsburgh Ohio State University University of Rochester Oregon Health and Science University University of Texas Southwestern SUNY Buffalo University of Utah SUNY Stony Brook University of Virginia – Charlottesville SUNY Upstate Vanderbilt University Swedish Medical Center - Seattle Washington University in St. Louis University of Alabama at Birmingham Weill Cornell Medical College
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Amyotrophic Lateral Sclerosis (ALS)
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Amyotrophic Lateral Sclerosis (ALS) “Lou Gehrig’s Disease”
ALS AFFECTS ~20,000 People In United states1 ORPHAN INDICATION
LIFE EXPECTANCY 2-5 YRS 1 FATAL
An effective new drug for ALS could generate sales of $1B+ 2 EXPECTED MARKET OPPORTUNITY
CURRENT APPROVED DRUGS RILUZOLE Increases survival by ONLY 2-3 month3
1. Source: ALS Association
2. Source: Cowen & Co. estimate
3. Cochrane Database of Systematic Reviews
17 © 2016 MediciNova, Inc.
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MN-166 Ibudilast
MN-166 Phase 2 ALS Trial Ongoing
ALS Trial Design
N = up to 120 ALS subjects with onset <10 years up to 60 without non-invasive ventilation (NIV) support up to 60 with NIV support
Phase 2 randomized, double-blind trial at Carolinas Neuromuscular/ALS-MDA Center
Principal Investigator: Dr. Benjamin Rix Brooks
Duration: 6 months of double-blind treatment + open label extension (6 months)
Dosing: 60 mg/day of MN-166 or placebo (2:1 randomization) with riluzole
Safety and tolerability, functional activity (ALSFRS-R), respiratory function, muscle strength, quality of life, Clinical Global Impression of Change, serum creatinine as a biomarker, and pharmacokinetics
Enrollment commenced in October 2014
Protocol amendment in September 2015 added advanced ALS subjects using non-invasive ventilation (NIV)
TRIAL DESIGN
OBJECTIVES
STATUS
18 © 2016 MediciNova, Inc.
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MN-166 Phase 2 ALS Trial: Interim Data at AAN (April 2016)
Interim analysis of 25 subjects without NIV support who completed the 6-month double-blind treatment period with complete respiratory function data.
No cluster of adverse events was differentially present in MN-166 and placebo treatment subjects.
Interim ALS Data Presented at AAN in April 2016 in Vancouver
ALSFRS-R Total* ALSFRS-R Bulbar ALSFRS-R Arm Slow Vital Capacity (SVC)
PLACEBO Mean Decline 5.80 (0.97 per month) 1.80 (0.30 per month) 2.40 (0.40 per month) 12.71% (2.12% per month)
MN-166 Mean Decline 4.55 (0.76 per month) 0.90 (0.15 per month) 1.50 (0.25 per month) 10.93% (1.82% per month)
IMPROVEMENT 22% 50% 38% 14%
* A higher decline indicates a greater worsening of disability.
Note: As this is the first study of MN-166 in ALS, it was not powered to detect statistical significance.
19 © 2016 MediciNova, Inc.
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MN-166 Ibudilast
MN-166: Addiction Study Summary
Summary of MN-166 Addiction Studies and Data
Opioid Withdrawal & Analgesia Phase 1b/2a Trial
Opioid Self-Administration Phase 2 Trial
Methamphetamine Dependence Phase Ib Trial
Alcohol Dependence Phase 2a Trial
MN-166 Reduced Subjective Opioid Withdrawal Scale (SOWS)
MN-166 significantly reduced perspiring (p<0.05) and hot flashes (p<0.05), two components of SOWS
MN-166 significantly decreased the craving for • heroin (p<0.01), • cocaine (p<0.01) • tobacco (p<0.05)
MN-166 significantly decreased the reinforcing effects of oxycodone (p<0.05)
MN-166 significantly enhanced the analgesic effects of oxycodone (p<0.05)
MN-166 significantly reduced perseverations (p=0.01) and variability in response times (p=0.006), suggesting a protective effect on sustained attention
MN-166 significantly decreased basal, daily alcohol craving over the course of the study (p<0.05)
20 © 2016 MediciNova, Inc.
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Fibrosis
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What is Fibrosis?
CROSS-LINKING OF COLLAGEN AND ELASTIN FIBROSIS
Fibrosis is the development of excess fibrous connective tissue in an organ
Fibrosis is a result of inflammation, irritation, or healing (e.g. scar)
Cross-linking of collagen and elastin is the final step in fibrosis development
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MN-001 Tipelukast
How does MN-001 work?
Anti-fibrotic Activity
Reduces mRNA expression of genes that are known to promote fibrosis (e.g. LOXL2, Collagen Type 1, TIMP-1)
Inhibits 5-lipoxygenase (5-LO)
Anti-inflammatory Activity
Inhibits leukotriene (LT) and phosphodiesterases (PDE)
Reduces inflammatory gene expression (e.g. CCR2, MCP-1)
Reduces Triglycerides
Reduced triglycerides in every clinical trial completed (asthma, interstitial cystitis)
MN-001
LOXL2 Collagen Type 1
CCR2
MCP-1 TIMP-1
MN-001
Cross-linking of collagen and elastin
fibrosis
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MN-001 Tipelukast
MN-001 Background
More than 600 human subjects exposed to MN-001 in prior studies
Completed Phase 2 study of MN-001 in asthma with positive results
MN-001 was considered generally safe and well-tolerated
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MN-001
MN-001 Data Tipelukast
NASH & NAFLD Animal Model Studies
Animal model studies shows MN-001 significantly reduced fibrosis in a dose-dependent manner
– Improved NAFLD Activity Score (NAS) via a reduction in hepatocyte ballooning
– Reduced fibrosis area in every preclinical model tested (NASH, Advanced NASH)
% of Fibrosis Area
NAFLD Activity Score (NAS)
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MN-001
MN-001 Data Tipelukast
IPF Animal Model Study
Ashcroft Score Lung Hydroxyproline
Animal model study shows MN-001 significantly reduced the Ashcroft Score
– Ashcroft Score measures pulmonary fibrosis based on histopathological staining
MN-001 significantly reduced lung hydroxyproline content
– Hydroxyproline content is an indicator of fibrosis or storage of collagen in tissue
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Nonalcoholic Steatohepatitis (NASH) Nonalcoholic Fatty Liver Disease ( NAFLD)
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Nonalcoholic Steatohepatitis (NASH)
NASH AFFECTS 2-5% of People In United States1 PREVALENCE
10-20% of U.S. population1 has “FATTY LIVER” due to being OVERWEIGHT OR OBESE
NASH MARKET FORECAST $ 1.6B By 20202
NO TREATMENT APPROVED
1. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2. Allied Market Research
28 © 2016 MediciNova, Inc.
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MN-001
Tipelukast
MN-001 Phase 2 NASH / NAFLD Trial
Ongoing
NASH / NAFLD Trial Design
N = 40 subjects with NASH with hypertriglyceridemia and NAFLD with hypertriglyceridemia
Phase 2 multicenter, proof-of-principle, open-label study Principal Investigator: Dr. Paul J. Pockros Duration: 12 weeks of treatment
Dosing: MN-001 250 mg once daily for 4 weeks, followed by MN-001 250 mg twice daily for 8 weeks
Evaluate the effect of MN-001 on:
1) Serum triglyceride levels; cholesterol efflux capacity
2) Safety and tolerability; PK profile; HDL-C, LDL-C, and total cholesterol level; liver enzymes and percent fat in liver at Week 12
Enrolling
© 2016 MediciNova, Inc.
TRIAL DESIGN
OBJECTIVES
STATUS
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Idiopathic Pulmonary Fibrosis (IPF)
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Idiopathic Pulmonary Fibrosis (IPF)
IPF PREVALENCE
132,000 -200,000
In United states1
ORPHAN INDICATION
LIFE EXPECTANCY
2-3 YRS1
IPF MARKET FORECAST
$3B+
By 20252
APPROVED DRUGS
ESBRIET
(pirfenidone)
- Approved in October 2014
- Phase 3 studies enrolled mild to moderate IPF
No survival benefit shown3
OFEV
(nintedanib)
- Approved in October 2014
- Phase 3 studies enrolled mild to moderate IPF
No survival benefit shown4
1. Pulmonary Fibrosis Foundation
2. GlobalData
3. Esbriet prescribing information
4. OFEV prescribing information
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MN-001
Tipelukast
MN-001 Phase 2 IPF Trial Ongoing
IPF Trial Design
N = 15 subjects with moderate to severe IPF
Phase 2 randomized, placebo-controlled, double-blind trial at Penn State Milton S. Hershey Medical Center
Principal Investigator: Dr. Rebecca Bascom
Duration: 26 weeks of double-blind treatment + open label extension (26 weeks)
Dosing: MN-001 750 mg or placebo twice daily (2:1 randomization)
1) Change from baseline of forced vital capacity (FVC) and FVC % predicted up to 26 weeks, and
2) Semiannual rate of decline of disease activity based on FVC
Others: Safety and tolerability; 6-minute walk test (6MWT); Modified Medical Research Council Dyspnea Score (MMRC); quality of life (ATAQ-IPF); frequency of worsening IPF; time to first worsening IPF
Enrolling
© 2016 MediciNova, Inc.
TRIAL DESIGN
OBJECTIVES
STATUS
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MN-001 Tipelukast
MN-001 (tipelukast): 6 New Patents
6 New Patents cover MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001):
NASH Treatment of nonalcoholic steatohepatitis (NASH); expires no earlier than Dec 2032
Advanced NASH Treatment of advanced NASH with fibrosis; expires no earlier than Sep 2034
NAFLD
Treatment of nonalcoholic fatty liver disease (NAFLD); expires no earlier than Dec 2032
Liver Disorders Treatment of steatosis, lobular inflammation, hepatic ballooning, hepatic scarring, and elevated liver hydroxyproline levels; expires no earlier than Dec 2032
Lipid Disorders Treatment of hypertriglyceridemia, hypercholesterolemia, and hyperlipoproteinemia; expires no earlier than July 2034
Fibrosis Treatment of fibrosis in a broad range of organs; expires no earlier than June 2035
AFLD (Alcoholic fatty liver disease)
NAFLD (Nonalcoholic fatty liver disease)
ASH (Alcoholic Steatosis steatohepatitis)
NASH (Nonalcoholic steatohepatitis)
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Financial Summary
CASH POSITION
$25 Million
(9/30/2016)
2015 OPERATING CASH BURN
$7.2 Million
* Year ended December 31
34
Consolidated Statements Of Operations And Comprehensive Loss
2015* 2014*
Operating Expenses ($)
Research, development and patent $ 3,017,169 $ 3,259,694 General and administrative 5,805,217 5,963,317 Total operating expenses 8,822,386 9,223,011 Operating loss (8,822,386) (9,223,011) Other expenses (54,206) (12,518) Interest expense (514) (628) Other income 39,386 36,893 Loss before income taxes (8,837,720) (9,199,264)) Income tax (expense) benefit (7,359) 3,972 Net loss applicable to common stockholders $ (8,845,079) $ (9,195,292) Basic and diluted net loss per common share $ (0.33) $ (0.38) Shares used to compute basic and diluted net loss per share 26,578,770 24,067,781
© 2016 MediciNova, Inc.
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Timeline Summary
166 - MN 001 - MN
Ibudilast Tipelukast 35
Progressive Multiple Sclerosis ALS Substance Dependence NASH IPF
2014 2015 New Protocol Submitted FDA Approval to Start Study Began Enrollment Positive Interim Data: Opioid Positive Preclinical Data Presented at AASLD and JDDW New Patents - NAFLD, steatosis / liver disorders Positive Preclinical Data Orphan Drug Designation Granted
2016 • Presentation at AAN • Completed Enrollment • Presentation at AAN • Amended Protocol (Advanced ALS) • Fast Track • Final Results: Alcohol • Opened IND • FDA Approved Protocol • New Patent covers NASH • Fast Track • Initiated Phase 2 Clinical Trial • FDA Approved Protocol • Fast Track • Initiated Phase 2 Clinical Trial © 2016 MediciNova, Inc.
2017 • Fast Track • Q4: Interim Analysis (NIH) • New Patent covers ALS • Initiated ALS Biomarker Study • Interim Data Presented at AAN • U. Orphan S. Drug Designation - • EMA Recommends Orphan Drug Designation - Europe • Final Results: Opioid • New Patent covers Advanced NASH • Lipid Disorders: New Patent covers hypertriglyceridemia, hypercholesterolemia, and hyperlipoproteinemia
Final Results 6-month double-blind data
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Investment Highlights
Novel product candidates
in Phase 2 clinical development with encouraging efficacy and safety data
MN-166 (ibudilast) MN-001 (tipelukast)
Treatment of Neurological Diseases i.e. Progressive MS, ALS, and Substance Dependence • • Treatment of Fibrotic Diseases i.e. IPF (idiopathic pulmonary fibrosis) Treatment of Hyperlipidemia and Fibrotic Disease i.e. NASH (nonalcoholic steatohepatitis) and
Approved in Japan in 1989 - post-stroke dizziness and asthma Large safety database NAFLD (nonalcoholic fatty liver disease)
Well capitalized
Experienced management team
36 © 2016 MediciNova, Inc.