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): September 25, 2015
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) |
(IRS 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. |
On September 25, 2015, 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.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit |
Description | |
| 99.1 | Slide presentation of the Company. | |
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SIGNATURES
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. | ||||||
| Dated: September 25, 2015 | By: | /s/ Yuichi Iwaki | ||||
| Yuichi Iwaki, M.D., Ph.D. | ||||||
| President and Chief Executive Officer | ||||||
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EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Slide presentation of the Company. | |
 © MediciNova, Inc. 2015
Developing Novel Therapeutics for the
Treatment of Serious Diseases with
Unmet Medical Needs
Exhibit 99.1 |
 © MediciNova, Inc. 2015
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, 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, 2014 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 September 25, 2015. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. Forward-Looking Statements |
 © MediciNova, Inc. 2015
Novel product candidates
in clinical development with encouraging efficacy
and safety data
MN-166 (ibudilast)
for the treatment of Neurology Diseases
including
Progressive MS, ALS, and Drug Dependence
Approved in Japan in 1989 (post-stroke dizziness and
asthma) Large safety database
MN-001 for the treatment of Fibrotic Diseases including NASH (nonalcoholic steatohepatitis) and IPF (idiopathic pulmonary fibrosis)
MN-221
for the treatment of acute exacerbations of asthma
Well capitalized
Experienced management team
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MediciNova Highlights |
 © MediciNova, Inc. 2015
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MediciNova: Active Programs in
Clinical Development |
 © MediciNova, Inc. 2015
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Neurodegenerative Diseases
Progressive Multiple Sclerosis “Progressive MS” • MS affects more than 400,000 people in the U.S. and 2.3 million worldwide 1 • Patients experience a diminished quality of life (e.g. fatigue, walking difficulties, weakness, pain, cognitive changes, depression) 1 • Market opportunity: Total sales of RRMS drugs were $18 billion worldwide in 2014. We believe Progressive MS market is at least as large as RRMS market. • Approved Drugs: NONE APPROVED for long-term treatment of Progressive MS Amyotrophic Lateral Sclerosis (ALS) “Lou Gehrig's Disease” 1. Source: National Multiple Sclerosis Society 2. Source: ALS Association 3. Source: Cowen & Co. estimate 4. Cochrane Database of Systematic Reviews • Fatal: ALS Life expectancy is 2-5 years 2 • ALS affects up to 30,000 people in the U.S. 2 (Orphan indication) • Market opportunity: an effective new drug for ALS could generate sales >$1 billion per year 3 • Approved Drugs: RILUZOLE increases survival by only 2-3 months 4 |
 © MediciNova, Inc. 2015
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Fibrotic Diseases
Idiopathic Pulmonary Fibrosis “IPF” Nonalcoholic Steatohepatitis “NASH” • NASH prevalence in the U.S. is 2-5% 1 • Additional 10-20% have “fatty liver” due to being overweight or obese 1 • NASH Market forecast: $1.6 billion by 2020 2 • Approved Drugs: NO TREATMENT APPROVED 1. National Digestive Diseases Information Clearinghouse (NDDIC) 2. Allied Market Research 3. Coalition for Pulmonary Fibrosis 4. Research and Markets 5. Esbriet prescribing information 6. OFEV prescribing information • IPF prevalence about 128,000 in the U.S. 3 (Orphan indication) • Two-thirds of IPF patients die within 5 years 3 • IPF Market forecast: >$1 Billion in 2017 4 • Approved Drugs: Esbriet (pirfenidone) approved in October 2014; Esbriet Phase 3 studies enrolled mild to moderate IPF; No survival benefit shown 5 • OFEV (nintedanib) approved in October 2014; Phase 3 studies enrolled mild to moderate IPF; No survival benefit shown 6 |
 © MediciNova, Inc. 2015
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Tipelukast
MN-001 Developing Novel Therapeutics… MEDICINOVA MN-166 Ibudilast |
 © MediciNova, Inc. 2015
GLIAL CELL ATTENUATION
Role of Glia:
•
Type of macrophage
•
Increases in number during brain damage
•
Glial activation leads to
neurodegeneration MIF Inhibition:
• Linked to attenuated disease progression in animal models of MS PDE inhibition • Increases cAMP, reducing inflammation 8 How does MN-166 work? |
 © MediciNova, Inc. 2015
MN-166 Phase 2 RRMS Data
• Significant attenuation of brain volume loss (p=0.035) • Significant attenuation of conversion of acute lesions to persistent black holes (p=0.004) • Sustained disability progression was significantly less likely (p=0.026) MN-166 Ongoing NIH-funded Phase 2b study • PPMS and SPMS study • Trial to be completed in 1H 2017 9 MN-166: MS Data |
 © MediciNova, Inc. 2015
MN-166 Opioid Withdrawal & Analgesia Phase 1b/2a
Trial •
Reduced
Subjective
Opioid
Withdrawal
Scale
(SOWS)
• Significantly reduced perspiring (p<0.05) and hot flashes (p<0.05), two
components of SOWS
MN-166
Opioid Self-Administration Phase 2a Trial (INTERIM DATA) • Significantly decreased the craving for heroin (p<0.05), cocaine (p<0.05), and tobacco (p<0.05) • Significantly decreased the positive subjective effects of oxycodone measured by mean responses to statements such as “I Feel High” (p<0.05) and
“I Liked the Dose” (p<0.05)
MN-166-Methamphetamine Phase Ib Trial
• Significantly reduced perseverations (p=0.01) and variability in response
times
(p=0.006),
suggesting
a protective effect on sustained attention 10 MN-166: Addiction Data |
 © MediciNova, Inc. 2015
FDA Granted Orphan Drug Designation to MN-166 for
Krabbe disease (June 2015) • Krabbe disease is a rare genetic degenerative disorder for which there is no
cure and is generally fatal before two years of age
• Only treatment option for Krabbe disease is hematopoietic stem cell
transplantation, which has limited efficacy and potential risk to the
patient MediciNova has Open
Investigational New Drug (IND) application with the
Division of Neurology Products (DNP) for MN-166
FDA Approval would generate valuable Priority Review Voucher • Rare Pediatric Disease Priority Review Voucher can be sold • BioMarin sold its voucher to Regeneron for $67.5 million (July 2014) • Retrophin sold its voucher to Sanofi for $245 million (May 2015)
• United Therapeutics sold its voucher to AbbVie for $350 million (August 2015)
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MN-166: Krabbe Disease |
 © MediciNova, Inc. 2015
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What is Fibrosis?
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
Cross-linking of collagen and elastin
fibrosis |
 © MediciNova, Inc. 2015
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How does Fibrosis Develop?
Genes Promoting Fibrosis
•
LOXL2
•
Collagen Type 1
•
CCR2 • MCP-1 • TIMP-1 LOXL2 Cross-linking of collagen and elastin fibrosis Collagen Type 1 CCR2 MCP-1 TIMP-1 |
 © MediciNova, Inc. 2015
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How does MN-001 work?
Tipelukast
MN-001 MN-001 LOXL2 Cross-linking of collagen and elastin fibrosis Collagen Type 1 CCR2 MCP-1 TIMP-1 MN-001 Reduces Gene Expression • LOXL2 • Collagen Type 1 • CCR2 • MCP-1 • TIMP-1 |
 © MediciNova, Inc. 2015
•
More than 600 human
subjects exposed to MN-001
Phase 2 study of MN-001 in
asthma with positive results
MN-001 was considered
generally safe and well-tolerated
•
Pre-clinical data shows anti-
fibrotic effect in a Dose-
Dependent Manner
•
Improved NAFLD Activity Score
(NAS) via a reduction in
hepatocyte ballooning
•
Reduced fibrosis area
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MN-001 Data NAFLD Activity Score (NAS) % of fibrosis area Tipelukast MN-001 |
 © MediciNova, Inc. 2015
Timeline - Progressive MS 16 Q2 2013: Submit New IND Amendment and New Protocol Q3 2013: FDA Approval of Protocol & Study Initiation Q4 2013: Began Enrollment Q2 2015: Presentation at AAN Q2 2015: Completed Enrollment 2H 2016: Interim analysis 1H 2017: Final Results Progressive Multiple Sclerosis “Progressive MS” |
 © MediciNova, Inc. 2015
Timeline - ALS 17 Amyotrophic Lateral Sclerosis (ALS) “Lou Gehrig's Disease” Q3 2014: Submit New ALS Protocol as IND Amendment Q3 2014: FDA Approval to Start Study Q4 2014: Began Enrollment Q2 2015: Presentation at AAN: Positive Interim Safety Review Q3 2015: Amended Protocol to include 60 Advanced ALS patients using non-invasive ventilation (NIV) Q4 2015: Interim data |
 © MediciNova, Inc. 2015
Timeline - NASH 18 Nonalcoholic Steatohepatitis (NASH) Tipelukast MN-001 Q1 2014: Positive preclinical data in NASH Q3 2014: Positive preclinical data in Advanced NASH Q4 2014: Present NASH data at AASLD and JDDW Q1 2015: Opened IND; FDA Approved Phase 2 Protocol Q1 2015: New Patent allowed for NASH Q2 2015: Fast Track designation granted ASAP: Initiate Phase 2 Study |
 © MediciNova, Inc. 2015
Timeline - IPF 19 Q2 2014: Positive preclinical data in pulmonary fibrosis Q3 2014: Present data at ICLAF Q4 2014: Prepare Protocol Q4 2014: FDA granted Orphan-drug designation to MN-001 for IPF Q1 2015: FDA Approved Phase 2 Protocol for moderate to severe IPF Q3 2015: Fast Track designation granted ASAP: Initiate Phase 2 Study Tipelukast MN-001 Idiopathic Pulmonary Fibrosis “IPF” |
 © MediciNova, Inc. 2015
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MN-001 (tipelukast): 3 New Patents
NASH: New Patent covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001)
for treatment of nonalcoholic steatohepatitis (NASH); Expires no earlier
than Dec 2032 NAFLD: New Patent
covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for treatment of nonalcoholic fatty liver disease (NAFLD); Expires no earlier than Dec 2032
Liver Disorders: New
Patent covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for the treatment of steatosis,
lobular
inflammation,
hepatic
ballooning,
hepatic
scarring, and elevated liver hydroxyproline levels; Expires no earlier
than Dec 2032 ASH
(Alcoholic steatohepatitis) NASH (Nonalcoholic steatohepatitis) NAFLD (Nonalcoholic fatty liver disease) AFLD (Alcoholic fatty liver disease) Steatosis |
 © MediciNova, Inc. 2015
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2014 • ALS: New Protocol Submitted • ALS: FDA Approval to Start Study • ALS: Began Enrollment • NASH: Positive Preclinical Data • NASH: Presented at AASLD and JDDW • IPF: Orphan Drug Designation Granted • New Patents cover NAFLD, steatosis, and other liver disorders 2015 • AAN Presentations for ALS and Progressive MS • Progressive MS: Completed Enrollment • ALS: Amended Protocol (Advanced ALS) • ALS: Interim Data • NASH: Opened IND; Protocol Approved, New Patent covers NASH, Fast Track • IPF: FDA Approved Protocol, Fast Track • NASH: Announce Next Steps • IPF: Announce Next Steps 2016 • Progressive MS: Interim Analysis 2017 • Progressive MS: Final Results MN-166 Ibudilast Tipelukast MN-001 Timeline Summary MEDICINOVA |