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 17, 2009
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.) |
4350 La Jolla Village Drive, Suite 950
San Diego, CA 92122
(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:
| x | 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 8.01 | Other Events. |
Representatives of MediciNova, Inc. (the “Registrant”) will be making a corporate presentation at various investor meetings commencing November 17, 2009. A copy of the slide presentation to be used by the Registrant at these meetings is attached hereto as Exhibit 99.1.
The information in this Current Report, including Exhibit 99.1 furnished herewith, is being furnished and shall not be deemed “filed” for any purpose, including for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Current Report shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description |
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| 99.1 | Slide presentation of the Registrant | |||||
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: November 17, 2009 |
By: | /s/ SHINTARO ASAKO | ||
| Shintaro Asako Vice President and Chief Financial Officer | ||||
EXHIBIT INDEX
| Exhibit |
Description |
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| 99.1 | Slide presentation of the Registrant | |||||
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MediciNova, Inc. 2009 Accelerating the global development and commercialization of innovative pharmaceuticals Exhibit 99.1 |
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MediciNova, Inc. 2009 Forward-Looking Statements 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 safety and efficacy of product candidates and the
potential novelty of such product candidates as treatments for disease, plans and
objectives for clinical trials and product development, anticipated benefits of the merger with Avigen, Inc., value and benefits to stockholders from such transaction, strategies, future performance, financial
condition, liquidity and capital resources. These forward-looking statements may be
preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can,"
"could," "may," "would," or similar expressions. Actual results or events may differ materially from those expressed or implied in any forward-looking statements due to various
factors, including the risks and uncertainties inherent in clinical trials and product
development and commercialization, such as the uncertainty in results of clinical trials for 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, 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, cost and design of future
clinical trials and research activities; the timing of expected filings with the FDA;
MediciNova’s failure to execute strategic plans or strategies successfully; MediciNova’s collaborations with third parties; failure to complete the merger with Avigen, Inc. on a timely basis or at all; the
availability of funds to complete product development plans and MediciNova’s
ability to raise sufficient capital when needed; intellectual property or contract rights; and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange
Commission, including MediciNova’s annual report on Form 10-K for the year
ended December 31, 2008 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 the date
hereof. MediciNova disclaims any intent or obligation to revise or update these
forward-looking statements. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. This material is not a
substitute for the registration statement/prospectus/proxy statement MediciNova, Inc.
and Avigen, Inc. will file with the SEC or any other documents that the parties may file with the SEC and send to their respective shareholders in connection with the transaction.
INVESTORS AND SECURITY HOLDERS OF AVIGEN, INC. ARE URGED TO READ ANY SUCH DOCUMENTS
FILED WITH THE SEC CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY
WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TRANSACTION. Investors and security holders will be able to obtain free copies of any documents filed with the SEC by MediciNova, Inc.
and Avigen, Inc. through the website maintained by the SEC at http://www.sec.gov. |
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MediciNova, Inc. 2009 3 Development Company Focused on Differentiated Product Candidates • Unique access to differentiated, potentially high-value assets primarily from Japanese alliances (Kyorin, Kissei, Mitsubishi Tanabe Pharma, Meiji) New Approaches to Treat Serious Medical Conditions: • MN-221: Intravenous (IV) acute asthma and COPD candidate • Potential $1 Billion+ combined market opportunity worldwide • MN-166: oral multiple sclerosis candidate • In 2008, over $8B in worldwide MS therapeutic sales* Key Financials: • Dual listed company on NasdaqGM and Osaka Securities Exchange – Hercules • ~$37.2 million net Cash, Cash Equivalents and Marketable Securities as of 9/30/2009
• ~$75.2 million Market Cap (NasdaqGM) as of 11/09/2009 • ~12 million shares outstanding Corporate Overview: Corporate Overview: MediciNova, Inc. MediciNova, Inc. *Source: Individual annual reports of leading MS companies, 2008 MNOV Headquarters: San Diego, CA |
 4 Merger Consideration • Each Avigen stockholder will have the option of receiving their pro rata allocation of cash or
convertible notes aggregating approximately $37.0 million (~$1.24/share),
subject to potential upward and downward adjustments as set forth in the merger
agreement: • First payment consideration of approximately $35.5 million (~$1.19/share); and
• Second payment consideration of approximately $1.5 million (~$0.05/share) payable on June 30, 2010. • This holdback amount is being held for any adjustments to certain Avigen defined expenses, marketable security risk, sub-tenant risk, and other liabilities in excess of amounts agreed by
the parties. Convertible Notes Consideration • 18-month maturity from the date of closing of merger (no early cash redemption). • Principal from the notes will be held in a trust account with principal invested in certain
approved investment options. • The notes can be converted on a monthly basis into common shares of MediciNova at an initial conversion price equal to $6.80. Avigen Avigen Transaction Overview Transaction Overview |
 Pro Forma
Stockholder Review Pro Forma Stockholder Review 5 This pro forma ownership review is presented for illustrative purposes only and does not indicate actual ownership of MediciNova shares at any past, present, of future date. Actual ownership of MediciNova shares will depend on a variety of factors, including the actual amounts of the First Payment
Consideration and Second Payment Consideration and the rounding of fractional shares set forth in the indenture governing the convertible notes. Summary Securities Ownership Review (Fully Diluted Basis) Pre -Transaction Pro Forma Shares Outstanding Post-Transaction (1) Consideration Shares All Cash 50% Cash 50% Conv. Notes (2) (3) 100% Conv. Notes (2) (3) Common Stock Equivalents MediciNova Stockholders 12,048,003 12,048,003 12,048,003 12,048,003 Avigen Stockholders - - 2,717,712 5,435,424 MediciNova Exercisable Options 1,711,350 1,711,350 1,711,350 1,711,350 13,759,353 13,759,353 16,477,065 19,194,777 Ownership % MediciNova Stockholders 87.6% 87.6% 73.1% 62.8% Avigen Stockholders 0.0% 0.0% 16.5% 28.3% MediciNova Exercisable Options 12.4% 12.4% 10.4% 8.9% 100.0% 100.0% 100.0% 100.0% (1) Assumes first payment consideration and second payment consideration aggregate $37.0 million and
are both paid at closing and that MediciNova issues no shares or options from August
20, 2009 through the first conversion date of the convertible notes. (2) Assumes the convertible notes convert to MediciNova shares at
$6.80. (3) Assumes all convertible notes are converted into MediciNova shares on the first monthly conversion
date. Sources of information: SEC Edgar Filings |
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MediciNova, Inc. 2009 6 MN-166 for Multiple Sclerosis (MS): • Oral administration • Multiple mechanisms of action, both neuroprotective and anti-inflammatory • MN-166 targets primarily chronic aspects of MS • Benign safety profile Mechanisms of Action: Potentially Neuroprotective • Inhibits Nitric Oxide and reactive oxygen species production • Stimulates release of neuronal growth factors Anti-inflammatory • Inhibits PDE4, Leukotriene, and Th1 cytokine production (TNF-alpha, IL-1beta,
IL-6) • Stimulates Th2 cytokine production (IL-4, IL-10) Current Standard of Care: • Beta interferons (Rebif ® , Avonex ® , Betaseron/Betaferon ® ), Copaxone ® , Tysabri ® • Primary focus is on acute treatment of MS symptoms (i.e. relapse rate) MN-166 for the Treatment of MN-166 for the Treatment of Multiple Sclerosis Multiple Sclerosis |
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MediciNova, Inc. 2009 Placebo-controlled, randomized, double-blind Phase II study: • Year 1 - Placebo, 30 mg/day, 60mg/day • Year 2 - 30 mg/day, 60mg/day • 297 patients (~100 patients/group) @ 25 sites in Serbia, Ukraine, Belarus, Bulgaria and Romania Key inclusion criteria: • Males or females aged 18 to 55 years, with relapsing remitting (RR) and/or secondary progressive (SP) Multiple Sclerosis with continued relapses; • One MRI scan taken two weeks prior to treatment start using a standardized MRI protocol with at least one Gd-enhancing lesion; • An Expanded Disability Status Scale (EDSS) score of 5.5 or less at the screening
and baseline visits. Safety Profile: • 89% (264 of 297) of subjects completed the first 12 months of the study • 82.5% (245 of 297) of subjects completed the full 24 months of the study • Adverse effects reported more frequently in MN-166-treated than placebo-treated
subjects: GI effects & depression Completed Clinical Study: Completed Clinical Study: MN-166-CL-001 MN-166-CL-001 7 |
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MediciNova, Inc. 2009 Indicative of Potential Neuroprotective Effect: • Reduced brain volume loss • Reduced conversion of acute lesions to persistent black holes • Sustained disability progression was significantly less likely Acute Clinical Benefit: • Prolong time to relapse (by 127 days.) • Annualized relapse rate Protocol-Defined Primary Endpoint: • No significant reduction in the cumulative number of active (gadolinium-enhancing (T1)
and non-enhancing new/enlarging (T2)) lesions on cranial MRI scans over 12
months of treatment was observed • Positive trends were observed in volume of gadolinium-enhancing (T1) lesions 8 MN-166 Targets Primarily MN-166 Targets Primarily Chronic Aspects of MS Chronic Aspects of MS Note: In general, P-Values listed on this slide compare Placebo group to
60mg/day group of MN-166 P-Value: 0.04 P-Value: 0.035 ~50% reduction P-Value: 0.004 P-Value: 0.09 P-Value: 0.08 |
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MediciNova, Inc. 2009 Brain volume changes are linked to axonal loss 9 MN-166 - MN-166 - Chronic Efficacy Chronic Efficacy Demonstrated: Effects on Brain Volume Demonstrated: Effects on Brain Volume |
 Parameter Treatment Groups Placebo 30 mg/day 60 mg/day Number Patients w. New Lesions at Month 2 72 64 56 Total Number New Lesions in all Patients at Month 2 426 338 315 Total Number of Persistent Black Holes at Month 10 98 58 47 Percentage of Lesions Evolving to PBH at Month 10 23% 17% 14% P-Value - 0.036 0.004 Reduction of Persistent Black Hole Reduction of Persistent Black Hole (PBH) Formation (PBH) Formation 10 © MediciNova, Inc. 2009 New T1 gadolinium-enhancing or new T2 lesions were defined as new lesion in the first on-study MRI at month 2 Lesions that were hypointense and inactive at month 10 were PBH Relative Risk (RR) of new lesion evolution to PBH was analyzed using a general linear model with the error term from the Poisson distribution |
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MediciNova, Inc. 2009 Disability Progression is defined as a sustained increase in EDSS (increase in EDSS 1 maintained for four consecutive months) Sustained Disability Progression Sustained Disability Progression 11 4.1% 5.3% 8.0% |
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MediciNova, Inc. 2009 12 Acute Efficacy Demonstrated: Acute Efficacy Demonstrated: Time to First Relapse Time to First Relapse Median 401 days Median 244 days P-Value: 0.044 Plot of Time to First Relapse by Treatment (ITT) Core (Year 1)
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MediciNova, Inc. 2009 13 AV-411 Package: Value to Potential MN-166 Partnership • Both AV-411 and MN-166 are ibudilast • AV-411 preclinical data expected to support clinical package for MN-166. • Open IND for ibudilast • AV-411 trial supports MN-166 dosing up to 100 milligrams (mg) versus the maximum
dosing of 60 mg in the Phase 2 trial for MN-166 • Expected time savings of six to twelve months. • Analog compounds behind ibudilast • First-generation development candidate: AV1013 • Second-generation dual target leads AV-411 Package: New Indication • AV-411 is currently being studied for Opioid Withdrawal • Ongoing clinical study run jointly by the New York State Psychiatric Institute and Columbia
University in NYC Additional Additional Value Value from from Avigen Avigen Deal Deal |
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MediciNova, Inc. 2009 14 Definition: • Asthma Exacerbations: Long-lasting and severe asthma episode that is not responsive to initial bronchodilator or corticosteroid therapy • COPD Exacerbations: Sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset Market Opportunity*: • Potential $1 Billion+ combined market opportunity worldwide (Acute Asthma & COPD exacerbations) Current Standard of Care (SOC): • Beta agonists - Inhaled • Anticholinergics - Inhaled • Corticosteroids - IV or oral *Source: National Center for Health Statistics / CDC, WHO website, “Core Health
indicators” MN-221 for Exacerbations of MN-221 for Exacerbations of Acute Asthma and COPD Acute Asthma and COPD COPD Discharged Hospitalized 72% 28% ~1.9 million Asthma 52% 48% ~1.5 million Hospitalization rates amongst Asthma and COPD patients Thousands |
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MediciNova, Inc. 2009 15 MN-221: A New Approach to Treating MN-221: A New Approach to Treating Exacerbations of Acute Asthma & COPD Exacerbations of Acute Asthma & COPD MN-221: A novel, highly selective 2 - adrenergic receptor agonist Three potential advantages over current therapy: 1. Improved Efficacy • Route of Administration (IV v. Inhalation) 2. Improved Safety • Higher selectivity for 2 receptor than 1 • Partial agonist for 1 receptor 3. Reduced Health Care Expenses |
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MediciNova, Inc. 2009 16 Human Human -Adrenergic Receptor -Adrenergic Receptor Selectivity Selectivity Test Drug 1 IC 50 (M) 2 IC 50 (M) 2 -Adrenoceptor Selectivity (IC 50 for 1 / IC 50 for 2 ) Levalbuterol 7.40E-06 1.40E-06 5.3 Albuterol 9.40E-06 1.60E-06 5.9 Terbutaline 6.00E-05 6.50E-06 9.2 MN-221 5.90E-06 1.40E-07 42.4 |
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MediciNova, Inc. 2009 Effect on Heart
rate: Effect on Heart
rate: Combination of MN-221 & Albuterol Combination of MN-221 & Albuterol in Dogs in Dogs 17 |
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MediciNova, Inc. 2009 MN-221 Clinical Trials MN-221 Clinical Trials 18 Completed Studies Completed Studies Ongoing Studies Ongoing Studies CL-004 CL-005 CL-006 CL-007 CL-010 Indication Indication Mild-to-moderate Asthmatics Moderate-to- Severe Asthmatics Acute Exacerbations of Asthma Acute Exacerbations of Asthma Moderate-to- Severe COPD patients FEV FEV 1 1 (Entry Criteria) (Entry Criteria) FEV 1 60% 75% FEV 1 40% FEV 1 55% FEV 1 50% 80% FEV 1 30% Number Number Patients Patients 23 17 29 200 48 Number Sites Number Sites 4 4 8 ~45 6 Doses Tested Doses Tested compared to compared to Placebo Placebo 5.25, 15, 52.5, 150, 240, 450, 900 µg over 15 min 1080 µg over 2-hr; 1,125 µg over 1-hr 240, 450 µg over 15 min; 1080 µg over 2-hr 1200 µg over 1-hr 300, 600, 1200 µg over 1-hr Note: CL-004, CL-005, CL-010 located in the clinic. CL-006,
CL-007 located in the Emergency Department |
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MediciNova, Inc. 2009 MN-221-CL-004:
MN-221-CL-004:
Mean Change in FEV Mean Change in FEV 1 1 19 p<0.05 p<0.0001 p<0.0001 p<0.0001 p<0.001 Baseline: 77.83% 77.67% 76.78% 81.60% 74.78% 75.78% 78.07% 79.78% © MediciNova, Inc. 2009 |
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MediciNova, Inc. 2009 MN-221-CL-005:
MN-221-CL-005:
Mean Change in FEV Mean Change in FEV 1 1 20 Baseline: 64.57% Baseline: 69.35% Mean: Mean: 82.04% 82.04% Mean: Mean: 81.47% 81.47% Baseline: 68.64% Baseline: 68.64% |
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MediciNova, Inc. 2009 21 What did we learn from MN-221-CL-006? • There were no safety concerns with adding MN-221 to the standard of care. • There was a reduction in the hospitalization rate among patients treated with MN-221. • Overall, improvement in FEV 1 was greater for patients receiving MN-221 than placebo. • A dose of 1,200 µg of MN-221 administered over one hour was selected for the MN-221-CL-007 trial. MN-221-CL-006:
MN-221-CL-006:
What have we learned? What have we learned? |
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MediciNova, Inc. 2009 MN-221-CL-006 MN-221-CL-006 Hospitalization Rate by Treatment Group Hospitalization Rate by Treatment Group 22 MN-221 reduced the hospitalization rate by 45% |
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MediciNova, Inc. 2009 Study Design • Randomized, placebo-controlled, double-blind, multi-center Phase II clinical
trial • 200 patients with severe, acute exacerbations of asthma (FEV 1 50% predicted) at ~45 Emergency Department sites in US, Canada, Australia, and New Zealand • Dose Groups (~100 patients/group): • 600 µg in 15 minutes; 600 µg for in minutes (1,200 µg) MN-221
• Placebo • Patients will receive Standard of Care (SOC) treatment in addition to adjunctive
treatment with MN-221 or placebo • Primary efficacy endpoint will be improvement in FEV 1 (% predicted) at 5 hours • The study is designed to have 80% power to detect a treatment difference
of 5 percentage points in FEV1 (% predicted) when comparing MN-221 + SOC
to Placebo + SOC at a two sided -level of 0.05. • Anticipated completion in 2H, 2010* MN-221-CL-007 MN-221-CL-007 23 Note: Development plans / timelines for MN-221 clinical trials are subject to
change *Anticipated completion dates based on current projections
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MediciNova, Inc. 2009 MN-221-CL-010 (COPD) MN-221-CL-010 (COPD) 24 Note: Development plans / timelines for MN-221 clinical trials are subject to
change *Anticipated completion dates based on current projections • Doses: • 150 µg in 15 minutes followed by 150 µg in 45 minutes (1-hour infusion with a
total dose of 300 µg) or placebo • 300 µg in 15 minutes followed by 300 µg in 45 minutes (1-hour infusion with a
total dose of 600 µg) or placebo • 600 µg in 15 minutes followed by 600 µg/min in 45 minutes (1-hour infusion
with a total dose of 1,200 µg) or placebo Study Design • Randomized, double-blind, placebo-controlled Phase Ib dose escalation study • 48 subjects with stable moderate-to-severe Chronic Obstructive Pulmonary Disease
(FEV 1 30% < 80% and FEV 1 /FVC ratio < 0.7) at 6 sites in the US • Outcome measures – descriptive statistics only – FEV 1 , PK, safety • Anticipated completion in 1H, 2010 |
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MediciNova, Inc. 2009 25 Commercially-Attractive Commercially-Attractive Diversified Portfolio Diversified Portfolio COPD COPD Asthma Asthma Seeking Global Partner Seeking Global Partner |
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MediciNova, Inc. 2009 26 Leadership Years Experience Background Yuichi Iwaki, MD, PhD Yuichi Iwaki, MD, PhD CEO & President 33 Professor at USC, formerly Professor at University of Pittsburgh; Advisor to JAFCO, Tanabe Shintaro Shintaro Asako, Asako, , Chief Financial Officer 11 KPMG USA (Audit), Arthur Andersen USA Masatsune Masatsune Okajima, Okajima,
, VP, Head of Japanese Office 17 Daiwa Securities SMBC, Sumitomo Capital Securities, Sumitomo Bank Management Team with Management Team with Global Experience Global Experience Clinical Development Consultant & Board Member 26 CEO of Panacos & Metaphore; President of the Janssen Research Foundation, a J&J company CPA CMA Alan Dunton, MD, PhD |
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MediciNova, Inc. 2009 27 Near-Term Business Plan: 1. Secure a global partnership for MN-166/AV-411 combined package* 2. Secure a regional partnership (ex-US/Japan rights) for MN-221 Clinical Milestones: 1. MN-221-CL-007 Phase II study for Acute Exacerbations of Asthma • Anticipated completion 2H, 2010** 2. MN-221-CL-010 Phase Ib study in Moderate-to-Severe COPD patients • Anticipated completion in 1H, 2010** Investment Highlights Investment Highlights Note: Development plans / timelines for MN-221 clinical trials are subject to
change *Assumes completion of acquisition of Avigen **Anticipated completion dates based on current projections |