Full Press Release Details
Corporate Presentation
Forward-Looking Statements
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.
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
3 2016 MediciNova, Inc.
Investment Highlights
Novel product candidates in
Phase 2 clinical development with encouraging efficacy and safety data
Treatment of Neurological Diseases i.e. Progressive MS, ALS, and Substance Dependence
Approved in Japan in 1989
- post-stroke dizziness
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)
Experienced management team
Programs in Clinical Development
Indications Status Preclinical Phase 1 Phase 2 Phase 3
MN-166, Oral Anti-Inflammatory / Neuroprotective
NEURODEGENERATIVE DISEASES
Progressive Multiple Sclerosis
FAST TRACK Ongoing: Fully Enrolled in Q2-2015
NeuroNEXT / Cleveland Clinic (Funded by NINDS)
ALS (Amyotrophic Lateral Sclerosis)
Neuromuscular / ALS-MDA Center Ongoing
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)
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
5 2016 MediciNova, Inc.
Developing Novel Therapeutics
Ibudilast Tipelukast
6 2016 MediciNova, Inc.
How does MN-166 work? MN-166 Ibudilast
Linked to attenuated disease progression in animal models of MS
Reduces pro-inflammatory cytokines
(i.e. IL-1, TNF-?, IL-6)
GLIAL CELL ATTENUATION
Activated during brain damage
Glial activation leads to neurodegeneration
7 2016 MediciNova, Inc.
Progressive Multiple Sclerosis (MS)
Progressive Multiple Sclerosis (MS)
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.)
APPROVED DRUGS For long-term treatment of Progressive MS
1. Source: National Multiple Sclerosis Society
9 2016 MediciNova, Inc.
MN-166 Phase 2 Relapsing MS Trial Completed MN-166 Ibudilast
Trial Design and Results
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
SAFETY: 82% completed the full 24 month study; AEs related to mild, self-limiting GI
Did not meet efficacy endpoint of MRI
lesion count*, which reflects markers of RRMS
Hit important neuroprotective endpoints related to disease
- 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.
MN-166 Phase 2 Relapsing MS Trial
Progression Data: 24 Months MN-166 Ibudilast
MN-166 Reduced Disability Progression* by 50%
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.
MN-166 Phase 2 Relapsing MS Trial