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): March 30, 2007
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:
| ¨ | 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 March 30, 2007, Dr. Kenneth Locke, Chief Scientific Officer of MediciNova, Inc. (the “Registrant”), gave a presentation regarding the status of the Registrant’s development programs to attendees of the Registrant’s Annual Meeting of Stockholders. Attached as Exhibit 99.1 hereto and incorporated herein by reference in its entirety is a copy of Dr. Locke’s presentation.
The information in this Item 7.01, including the exhibits furnished herewith, is furnished pursuant to Item 7.01 and shall not be deemed “filed” for any purpose, including for the 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 Item 7.01 of this Current Report on Form 8-K shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act regardless of any general incorporation language in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit | Description | |
| 99.1 | Slide Presentation presented March 30, 2007 |
2
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.
Dated: March 30, 2007.
| MEDICINOVA, INC. | ||
| By: | /s/ Shintaro Asako | |
| Shintaro Asako | ||
| Chief Financial Officer | ||
3
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Slide Presentation presented March 30, 2007 |
4
 ©
MediciNova, Inc. 2007 Accelerating the global development and commercialization of innovative pharmaceutical products Accelerating the global development and commercialization of innovative pharmaceutical products Exhibit 99.1 |
 ©
MediciNova, Inc. 2007 This presentation may contain “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include statements regarding the expected progress of the development of the Company’s product candidates and potential licensing, collaboration and partnering plans. These statements are based on certain assumptions made by the Company’s management that are believed to be reasonable at the time. Such statements are subject to a
number of assumptions, risks and uncertainties, many of which are beyond the control of the Company, including results of clinical studies, interest of potential collaborators in the market and other risks and uncertainties, including those described in the Company’s filings with the
Securities and Exchange Commission. These assumptions, risks and uncertainties could cause the Company’s actual results to differ materially
from those implied or expressed by the forward-looking statements. Safe Harbor Statement Safe Harbor Statement |
 ©
MediciNova, Inc. 2007 • US-based pharmaceutical development company: – Unique access to differentiated, high-value, lower-risk in-licensed assets from
Japanese alliances – Focused on mid-to-late stage clinical development – Management team has global development/commercialization experience • Commercially-attractive clinical pipeline: – 8 compounds in 10 different therapeutic
indications; 7 programs in Phase II or later – Key market advantages for each unique molecule – Multi-billion dollar collective market potential • Well-capitalized: – $212 M raised from inception; $104 M cash as of 12/31/06 – Successful IPO ($122.5 M gross) on Osaka Securities Exchange (OSE; code: 4875) in February 2005 – NASDAQ listing December 2006 (MNOV); recent NASDAQ offering (1 M shares @ $12) in February 2007 to introduce MNOV to new US shareholders Corporate Overview Corporate Overview |
 ©
MediciNova, Inc. 2007 Business Model Business Model • In-license high-value, differentiated small molecule product candidates at the late
preclinical-early Phase II clinical development stage at attractive terms
from mid-sized Japanese pharmaceutical companies • Add significant value through rapid advancement of product candidates through proof-of-concept Phase II/III clinical trials • Secure strategic alliances at key value inflection points • Selectively retain and commercialize certain product candidates for maximum ROI Sales/ Marketing Phase III Phase II Phase I Late Preclinical Research Drug Development Partner: $$$$$ Commercialize: $$$$$$$$$$ In-License: $ |
 ©
MediciNova, Inc. 2007 Proven Global Success of Drugs In-Licensed from Japan Proven Global Success of Drugs In-Licensed from Japan Drugs discovered in Japan are being snapped up by Western companies: Drug (Date Launched) Treatment Japanese Discoverer Partner in U.S. Peak World-Wide Sales Pravachol (1991) High cholesterol Sankyo Bristol-Myers Squibb $3.3 billion Prevacid (1995) Heartburn Takeda Abbott $4.3 billion Aricept (1997) Alzheimer's Eisai Pfizer $1.1 billion Abilify (2002) Schizophrenia Otsuka Bristol-Myers Squibb $2 billion (a) Crestor (2003) High cholesterol Shionogi AstraZeneca $4 billion (a) (a) Analyst estimate Source: the companies Others: Pepcid (Merck), Cardizem (Aventis), Lupron (TAP), Atacand (AstraZeneca),
Biaxin (Abbott), Levaquin (J&J), Noroxin (Merck), Tequin (BMS)
….MORE |
 ©
MediciNova, Inc. 2007 Japanese Pharma Alliances Japanese Pharma Alliances • Unique access to mid-sized Japanese pharma companies with no U.S. and/or European development capabilities • Acquire rights to select, high quality compounds in U.S. and select ex-U.S. markets • Favorable deal terms: – Modest milestone payments (e.g., no more than $1M upfront) – Reasonable royalties (e.g., 14% maximum on U.S. sales > $500M) – No stacking royalties (i.e., ~65/35% split with originator on out-licensing) • Proven track record – 8 compounds acquired in 6 years • Self-renewing model 553 Kissei 602 Kyorin 618 Mochida 681 Kaken 741 Tsumura 759 Hisamitsu 842 Santen 995 Meiji 1,422 Kyowa-Hakko 1,320 Ono 1,563 Tanabe 1,812 Shionogi 2,129 Mitsubishi 2,540 Taisho 2,863 Chugai 2,874 Sumitomo 4,845 Eisai 7,836 Astellas 8,330 Daiichi-Sankyo 10,208 Takeda 2005 Sales ($M) Japanese Pharmaceutical Company MediciNova partner Conduct US trials directly |
 ©
MediciNova, Inc. 2007 Commercially-Attractive Diversified Portfolio Commercially-Attractive Diversified Portfolio 6 Years 8 Compounds 10 Indications 6 Years 8 Compounds 10 Indications Product candidate (indication) Preclinical Phase 1 MN-166 (Multiple sclerosis) MN-305 (Anxiety Disorders/Insomnia) MN-221 (Status Asthmaticus) MN-001 (Bronchial asthma) MN-001 (Interstitial cystitis) MN-029 (Solid tumors) Phase 2 Phase 3 MN-246 (Urinary incontinence) Approval MN-221 (Preterm labor) MN-447 & MN-462 (Thrombosis) |
 ©
MediciNova, Inc. 2007 3 Near-Term Opportunities Show Pipeline Breadth and Value 3 Near-Term Opportunities Show Pipeline Breadth and Value • MN-001: Bronchial Asthma – Phase III initiated 4Q06 – Bonus indication: interstitial cystitis - in pivotal Phase II/III – >$1B 5 th year sales • MN-221: Status Asthmaticus – Phase II initiated 4Q06 – Potential to change treatment paradigm – >$500M 5 th year sales • MN-166: Multiple Sclerosis – Positive 297-patient Phase II; Phase III to start 2H07 – Capitalizes on market need for oral medication – >$1B 5 th year sales Product candidate (indication) Preclinical Phase 1 MN-166 (Multiple sclerosis) MN-305 (Anxiety Disorders/Insomnia) MN-221 (Status Asthmaticus) MN-001 (Bronchial asthma) MN-001 (Interstitial cystitis) MN-029 (Solid tumors) Phase 2 Phase 3 MN-246 (Urinary incontinence) Approval MN-221 (Preterm labor) MN-447 & MN-462 (Thrombosis) Product candidate (indication) Preclinical Phase 1 MN-166 (Multiple sclerosis) MN-305 (Anxiety Disorders/Insomnia) MN-221 (Status Asthmaticus) MN-001 (Bronchial asthma) MN-001 (Interstitial cystitis) MN-029 (Solid tumors) Phase 2 Phase 3 MN-246 (Urinary incontinence) Approval MN-221 (Preterm labor) MN-447 & MN-462 (Thrombosis) |
 ©
MediciNova, Inc. 2007 MN-001 (Asthma) MN-001 (Asthma) Positive US Phase II results (12/05); Phase III initiated 4Q06 Milestones – Combined mechanism of leading brands (Singulair®, Zyflo® and Daxas®) with broader efficacy – Improved safety (no steroid-like side effects) – Convenience of oral administration (improved compliance) – New US composition patent (market exclusivity > 2023) Advantages 5 th yr sales > $1 B Market Potential Kyorin Pharmaceutical (2002) Source |
 ©
MediciNova, Inc. 2007 MN-001 Competitive Advantages MN-001 Competitive Advantages < $90M Liver toxicity No No BID Accolate > $3B No Yes Yes TID/BID; QD in development MN-001 < $10M Liver toxicity No No QID; BID in clinical trials Zyflo No Safety Issues $3B No No QD Singulair Market Opportunity Steroid Sparing Anti- Inflammatory Dosing Compound Potential First Line Therapy for the Treatment of Bronchial Asthma
|
 ©
MediciNova, Inc. 2007 MN-001 Value-Added MN-001 Value-Added At Acquisition • Large preclinical and early clinical database Value-Added • Elucidation of mechanism of action • cGMP manufacturing (API and new formulation) • Expanded dose range (through Phase I testing) • Clinical proof-of-concept (in Phase II trial) • New composition of matter and method of manufacture patent • New indication – Interstitial Cystitis (Ph II/III results 4Q06) Next Steps (in progress) • Phase III clinical testing to establish market differentiation (oral controller with
anti-inflammatory activity, steroid-sparing) • Develop once-a-day dosage form |
 ©
MediciNova, Inc. 2007 MN-001 Key Data MN-001 Key Data Mean FEV1 (L) Change from Baseline Population: Intent-to-Treat (Observed Cases) FEV1: Forced expiratory volume in the first second. Note: Baseline is the Visit 3 pre-bronchodilator measurement. p=0.021 p=0.058 p=0.305 Proof-of-Concept in Mild-to-Moderate Asthmatics Statistically significant improvement in mean FEV1 after 4 weeks with 500 mg TID compared to placebo (p=0.021; intent-to-treat, observed cases) -0.5 -0.4 -0.3 -0.2 -0.1 0.0 0.1 0.2 0.3 0.4 0.5 Placebo 500mg TID MN-001 750mg BID MN-001 750mg QD MN-001 |
 ©
MediciNova, Inc. 2007 MN-221 (Status Asthmaticus) MN-221 (Status Asthmaticus) US Phase II 4Q06 Milestones – Clinically-proven mechanism of action (highly selective 2 -adrenergic receptor agonist) – Greater cardiovascular safety (less 1 - adrenergic receptor stimulation) – More reliable, effective and rapid route of administration (i.v. vs. inhaled) Advantages 5 th yr sales ~ $500 M Market Potential Kissei Pharmaceutical (2004) Source |
 ©
MediciNova, Inc. 2007 MN-221 Competitive Advantages MN-221 Competitive Advantages No Yes Yes Yes IV (Ph II) MN-221 ? ? Yes Rapid Action Yes Yes No Reliable Delivery Liver toxicity No IV (Ph I / II) Zyflo No No IV (Ph III) Singulair Cardiovascular (palpitations) Safety Issues Yes Inhaled; nebulized ß-Agonists Proven Mechanism Dosing Compound |
 ©
MediciNova, Inc. 2007 MN-221 Value-Added MN-221 Value-Added At Acquisition • Large preclinical and early clinical database (in preterm labor) Value-Added • Initiated cGMP product manufacturing • Changed clinical dosing paradigm • Determined safety of new dosing paradigm (through Phase I testing) • New indication – Status Asthmaticus Next Steps (in progress) • Phase II proof-of-concept testing |
  ©
MediciNova, Inc. 2007 MN-221 Key Data MN-221 Key Data Recovery from Ragweed-induced Bronchoconstriction in Dogs 0 1 2 3 4 5 0 10 20 30 40 50 60 70 80 90 100 110 120 Vehicle MN-221 (400 g/kg) baseline response MN-221 (120 g/kg) MN-221 ( 0 g/kg) MN-221 (12 g/kg) MN-221 g/kg) MN-221 (0.4 g/kg) peak response Time after Injection (minutes) |
 ©
MediciNova, Inc. 2007 MN-166 (Multiple Sclerosis) MN-166 (Multiple Sclerosis) Positive Phase II results 1Q07; Phase III to start 2H07 Milestones – Oral treatment for MS – 16 years proven clinical safety and efficacy in inflammatory disorders (asthma, stroke) in Japan – Large preclinical and clinical database (3.2M patients treated; >15,000 in formal clinical safety database) – New US use patent Advantages 5 th yr sales ~ $1 B Market Potential Kyorin Pharmaceutical (2004) Source |
 ©
MediciNova, Inc. 2007 No neutralizing antibodies formed; no loss of effect Pilot clinical data suggestive of 50% reduction in relapse Oral MN-166 Relative benefit gained from existing drugs may decline over time - possibly due to presence of neutralizing antibodies Current relapse reduction rate is ~33% (Significant market advantage for a drug with a relapse reduction rate of 50% or higher) Intravenous or subcutaneous injection (Injection site pain, swelling, and itching) Interferon Products Longer duration of effect Greater efficacy More convenient dosing Unmet Need MN-166 Competitive Advantages MN-166 Competitive Advantages |
 ©
MediciNova, Inc. 2007 MN-166 Value-Added MN-166 Value-Added At Acquisition • Large preclinical and clinical database • 16 years of clinical safety history • Pilot data in MS patients Value-Added • Completed first year of large (297-patient) clinical proof-of- concept Phase II study • Initiated cGMP API manufacturing Next Steps (in progress) • Phase III clinical testing • Develop once-a-day dosage form |
 ©
MediciNova, Inc. 2007 Reduction of Relapse Rate in 6 MS Patients Normalization of Serum Cytokine Levels in 11 MS Patients Cytokine % Change Th1 IFN- -28 TNF- -35 Th2 IL-4 +119 IL-10 +64 0 1 2 3 4 5 Pre-Treatment Post-Treatment MN-166 Key Pilot Clinical Data MN-166 Key Pilot Clinical Data |
 ©
MediciNova, Inc. 2007 MN-166 Key Phase II Data MN-166 Key Phase II Data 0.0352 % brain volume change: pbo: -1.2%, 60 mg: -0.79% 0.087 Cumulative volume of Gd-enhancing lesions: pbo - 2128 mm 3 , 60 mg - 1756 mm 3 0.033 % of subjects exacerbation-free for 1 year: pbo - 41%, 60 mg - 56.1% 0.0438 Time to first relapse: Median for 60 mg > 1 year Median for pbo - 244 days 0.0752 Completers - annualized relapse rate: pbo - 0.8, 60 mg - 0.6 (pbo - 42.7% vs. 60 mg - 60% with no relapses) p-value (pbo vs. 60 mg/d) Outcome Measure |
 ©
MediciNova, Inc. 2007 Renewable Business Model: Two Newly-Acquired Product Opportunities Renewable Business Model: Two Newly-Acquired Product Opportunities • Two novel cardiovascular preclinical products acquired from 4 th Japanese partner (Meiji Seika Kaisha, Ltd.) • Modest investment with potentially large return in multi-$B cardiovascular market – MN-447 – Antithrombotic with novel MOA (GPIIbIIIa/ v 3) affecting clot formation – MN-462 – Antithrombotic with novel MOA (carboxypeptidase b inhibitor) affecting clot lysis • Underscores ability to replenish pipeline with innovative, high-value product opportunities Product candidate (indication) Preclinical Phase 1 MN-166 (Multiple sclerosis) MN-305 (Anxiety Disorders/Insomnia) MN-221 (Status Asthmaticus) MN-001 (Bronchial asthma) MN-001 (Interstitial cystitis) MN-029 (Solid tumors) Phase 2 Phase 3 MN-246 (Urinary incontinence) Approval MN-221 (Preterm labor) MN-447 & MN-462 (Thrombosis) Product candidate (indication) Preclinical Phase 1 MN-166 (Multiple sclerosis) MN-305 (Anxiety Disorders/Insomnia) MN-221 (Status Asthmaticus) MN-001 (Bronchial asthma) MN-001 (Interstitial cystitis) MN-029 (Solid tumors) Phase 2 Phase 3 MN-246 (Urinary incontinence) Approval MN-221 (Preterm labor) MN-447 & MN-462 (Thrombosis) |
          ©
MediciNova, Inc. 2007 Management Team with Global Experience Management Team with Global Experience Ligand, General Electric Medical Systems, Hybritech, Molecular Biosystems 24 Lynn Terhorst, MBA VP, Business Planning & Analysis Clinical Advisors, D3 Capital, Lippert/Heilshorn, Sutro & Co. 24 Bonnie Feldman, DDS, MBA VP, Investor Relations & Corporate Communications 15 8 22 29 31 Years Experience Daiwa Securities SMBC, Sumitomo Capital Securities, Sumitomo Bank Masatsune Okajima, CMA VP, Head of Japanese Office KPMG USA (Audit), Arthur Andersen USA Shintaro Asako, CPA Chief Financial Officer Incara, Indevus, BMS Richard Gammans, PhD, MBA Chief Development Officer Tanabe Research Laboratories USA, Indevus, Hoechst Kenneth W. Locke, PhD Chief Business Officer Prof. USC, Pitt; Advisor to JAFCO, Tanabe Director, Avigen, Inc. Yuichi Iwaki, MD, PhD Executive Chairman, CEO Life Sciences Background LEADERSHIP |
 ©
MediciNova, Inc. 2007 MediciNova, Inc. Today MediciNova, Inc. Today • Market-driven, commercially-focused mid-stage pharma company • Innovative business model: – Steady inflow of high-quality molecules, primarily from mid-size Japanese
pharma – Focus on large, lucrative, underserved markets – Therapeutic & and molecular diversity lowers risk & optimizes reward • Rich mid- to late-stage clinical development pipeline: – 6 years, 8 compounds, 10 indications – Small molecules with clear market advantages & strong IP – Multi-billion dollar market potential • Portfolio growth strategy: build to profitability through out- licensing & retained commercial rights • Well-capitalized: poised for success |