UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED September 30, 2013
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROM TO |
Commission file number: 001-33185
MEDICINOVA, INC.
(Exact name of registrant as specified in its charter)
Delaware | 33-0927979 | |
(State or Other Jurisdiction of Incorporation or Organization) |
(I.R.S. Employer Identification No.) | |
4275 Executive Drive, Suite 650 La Jolla, CA |
92037 | |
(Address of Principal Executive Offices) | (Zip Code) |
(858) 373-1500
(Registrants Telephone Number, Including Area Code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a small reporting company. See definition of accelerated filer, large accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer | ¨ | Accelerated filer | ¨ | |||
Non-accelerated filer | ¨ (Do not check if a smaller reporting company) | Smaller reporting company | x |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
As of November 6, 2013, the registrant had 22,397,943 shares of Common Stock ($0.001 par value) outstanding.
MEDICINOVA, INC.
(a development stage company)
3 | ||||||
ITEM 1. | 3 | |||||
ITEM 2. | MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
14 | ||||
ITEM 3. | 23 | |||||
ITEM 4. | 23 | |||||
PART II. OTHER INFORMATION | 24 | |||||
ITEM 1. | 24 | |||||
ITEM 1A. | 24 | |||||
ITEM 6. | 24 | |||||
SIGNATURES | 26 |
2
ITEM 1. | CONSOLIDATED FINANCIAL STATEMENTS. |
MEDICINOVA, INC.
(a development stage company)
CONSOLIDATED BALANCE SHEETS
September 30, 2013 |
December 31, 2012 |
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(Unaudited) | ||||||||
Assets |
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Current assets: |
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Cash and cash equivalents |
$ | 10,660,849 | $ | 4,010,530 | ||||
Prepaid expenses and other current assets |
378,248 | 411,592 | ||||||
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Total current assets |
11,039,097 | 4,422,122 | ||||||
Goodwill |
9,600,241 | 9,600,241 | ||||||
In-process research and development |
4,800,000 | 4,800,000 | ||||||
Investment in joint venture |
676,481 | 667,204 | ||||||
Property and equipment, net |
80,801 | 78,474 | ||||||
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Total assets |
$ | 26,196,620 | $ | 19,568,041 | ||||
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
$ | 186,892 | $ | 491,853 | ||||
Accrued expenses |
472,426 | 314,652 | ||||||
Accrued compensation and related expenses |
440,086 | 228,124 | ||||||
Current deferred revenue |
| 3,163 | ||||||
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Total current liabilities |
1,099,404 | 1,037,792 | ||||||
Deferred tax liability |
1,956,000 | 1,956,000 | ||||||
Long-term deferred revenue |
1,694,163 | 1,694,257 | ||||||
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Total liabilities |
4,749,567 | 4,688,049 | ||||||
Stockholders equity: |
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Preferred stock, $0.01 par value; 3,000,000 shares authorized at September 30, 2013 and December 31, 2012; 220,000 shares issued and outstanding at September 30, 2013 and December 31, 2012 |
2,200 | 2,200 | ||||||
Common stock, $0.001 par value; 100,000,000 shares authorized at September 30, 2013 and December 31, 2012; 22,377,943 and 17,407,311 shares issued at September 30, 2013 and December 31, 2012, respectively, and 22,377,943 and 17,403,125 shares outstanding at September 30, 2013 and December 31, 2012, respectively |
22,378 | 17,407 | ||||||
Additional paid-in capital |
326,300,292 | 312,293,225 | ||||||
Accumulated other comprehensive loss |
(77,838 | ) | (67,957 | ) | ||||
Treasury stock, at cost; 0 shares at September 30, 2013 and 4,186 shares at December 31, 2012 |
(1,124,389 | ) | (1,131,086 | ) | ||||
Deficit accumulated during the development stage |
(303,675,590 | ) | (296,233,797 | ) | ||||
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Total stockholders equity |
21,447,053 | 14,879,992 | ||||||
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Total liabilities and stockholders equity |
$ | 26,196,620 | $ | 19,568,041 | ||||
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See accompanying notes.
3
MEDICINOVA, INC.
(a development stage company)
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
Three months ended September 30, |
Nine months ended September 30, |
Period from September 26, 2000 (inception) to September 30, 2013 |
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2013 | 2012 | 2013 | 2012 | |||||||||||||||||
Revenues |
$ | | $ | 83,787 | $ | 3,257 | $ | 768,584 | $ | 2,364,064 | ||||||||||
Operating expenses: |
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Cost of revenues |
| | | | 1,258,421 | |||||||||||||||
Research and development |
785,573 | 872,555 | 2,427,650 | 4,234,956 | 169,482,305 | |||||||||||||||
General and administrative |
1,456,774 | 1,573,943 | 5,023,445 | 5,057,802 | 117,280,813 | |||||||||||||||
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Total operating expenses |
2,242,347 | 2,446,498 | 7,451,095 | 9,292,758 | 288,021,539 | |||||||||||||||
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Operating loss |
(2,242,347 | ) | (2,362,711 | ) | (7,447,838 | ) | (8,524,174 | ) | (285,657,475 | ) | ||||||||||
Impairment charge on investment securities |
| | | | (1,735,212 | ) | ||||||||||||||
Other expense |
(395 | ) | (14,329 | ) | (5,920 | ) | (19,376 | ) | (395,150 | ) | ||||||||||
Interest expense |
| | | | (3,605,818 | ) | ||||||||||||||
Other income |
7,798 | 4,090 | 14,315 | 22,027 | 19,159,498 | |||||||||||||||
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Loss before income taxes |
(2,234,944 | ) | (2,372,950 | ) | (7,439,443 | ) | (8,521,523 | ) | (272,234,157 | ) | ||||||||||
Income taxes |
(1,806 | ) | (5,818 | ) | (2,350 | ) | (5,818 | ) | (78,311 | ) | ||||||||||
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Net loss |
(2,236,750 | ) | (2,378,768 | ) | (7,441,793 | ) | (8,527,341 | ) | (272,312,468 | ) | ||||||||||
Accretion to redemption value of redeemable convertible preferred stock |
| | | | (98,445 | ) | ||||||||||||||
Deemed dividend resulting from beneficial conversion feature on Series C redeemable convertible preferred stock |
| | | | (31,264,677 | ) | ||||||||||||||
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Net loss applicable to common stockholders |
$ | (2,236,750 | ) | $ | (2,378,768 | ) | $ | (7,441,793 | ) | $ | (8,527,341 | ) | $ | (303,675,590 | ) | |||||
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Basic and diluted net loss per common share |
$ | (0.10 | ) | $ | (0.14 | ) | $ | (0.37 | ) | $ | (0.52 | ) | ||||||||
Shares used to compute basic and diluted net loss per common share |
22,301,773 | 16,585,172 | 20,114,289 | 16,273,247 | ||||||||||||||||
Net loss applicable to common stockholders |
$ | (2,236,750 | ) | $ | (2,378,768 | ) | $ | (7,441,793 | ) | $ | (8,527,341 | ) | $ | (303,675,590 | ) | |||||
Other comprehensive loss, net of tax: |
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Foreign currency translation adjustments |
756 | 2,864 | (9,881 | ) | (2,019 | ) | (77,838 | ) | ||||||||||||
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Comprehensive loss |
$ | (2,235,994 | ) | $ | (2,375,904 | ) | $ | (7,451,674 | ) | $ | (8,529,360 | ) | $ | (303,753,428 | ) | |||||
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See accompanying notes.
4
MEDICINOVA, INC.
(a development stage company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine months ended September 30, |
Period
from September 26, 2000 (inception) to September 30, 2013 |
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2013 | 2012 | |||||||||||
Operating activities: |
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Net loss |
$ | (7,441,793 | ) | $ | (8,527,341 | ) | $ | (272,312,468 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Non-cash stock-based compensation |
719,084 | 540,385 | 51,110,015 | |||||||||
Amortization of Kissei upfront payment |
(3,257 | ) | (768,584 | ) | (805,837 | ) | ||||||
Depreciation and amortization |
90,966 | 35,519 | 2,105,918 | |||||||||
Amortization of premium/discount on investment securities, convertible debt, debt discount and issuance costs |
| | (1,099,365 | ) | ||||||||
Impairment charge, net on investment securities and ARS Put |
| | 1,735,212 | |||||||||
(Gain)/loss on disposal of assets |
(4,800 | ) | | 6,660 | ||||||||
Impairment of sublease |
| | 35,259 | |||||||||
Changes in operating assets and liabilities: |
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Prepaid expenses and other assets |
(30,635 | ) | 103,108 | (341,299 | ) | |||||||
Accounts payable, income tax payable, accrued expenses and deferred rent |
(166,345 | ) | (664,938 | ) | 378,689 | |||||||
Accrued compensation and related expenses |
211,962 | (395,957 | ) | 343,945 | ||||||||
Restricted assets |
| | 5,982 | |||||||||
Deferred Revenue |
| | 2,500,000 | |||||||||
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Net cash used in operating activities |
(6,624,818 | ) | (9,677,808 | ) | (216,337,289 | ) | ||||||
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Investing activities: |
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Cash paid for acquired business, net of acquired cash |
| | (2,829,785 | ) | ||||||||
Purchases of investment securities |
| | (377,205,766 | ) | ||||||||
Maturities or sales of investment securities |
| | 377,918,240 | |||||||||
Acquisition of property and equipment |
(29,314 | ) | (83,176 | ) | (2,390,282 | ) | ||||||
Investment in joint venture |
| (680,000 | ) | (680,000 | ) | |||||||
Proceeds from sales of property and equipment |
4,800 | | 261,645 | |||||||||
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Net cash used in investing activities |
(24,514 | ) | (763,176 | ) | (4,925,948 | ) | ||||||
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Financing activities: |
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Proceeds from issuance of common stock, warrants and units, net of issuance costs |
13,292,954 | 1,033,764 | 145,958,179 | |||||||||
Proceeds from issuance of convertible preferred stock, net of issuance costs |
| | 85,572,825 | |||||||||
Proceeds from ARS loan |
| | 17,605,485 | |||||||||
Net proceeds from debt |
| | 14,670,000 | |||||||||
Proceeds from conversion of convertible notes |
| | 1,881,253 | |||||||||
Purchase of treasury stock, net of employee stock purchases |
6,697 | 58,619 | (1,158,171 | ) | ||||||||
Repayments of debt |
| | (15,000,000 | ) | ||||||||
Repayments of ARS loan |
| | (17,605,485 | ) | ||||||||
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Net cash provided by financing activities |
13,299,651 | 1,092,383 | 231,924,086 | |||||||||
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Net increase/ (decrease) in cash and cash equivalents |
6,650,319 | (9,348,601 | ) | 10,660,849 | ||||||||
Cash and cash equivalents, beginning of period |
4,010,530 | 15,093,124 | | |||||||||
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Cash and cash equivalents, end of period |
$ | 10,660,849 | $ | 5,744,523 | $ | 10,660,849 | ||||||
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Supplemental disclosure of investing and financing activities: |
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Issuance of warrants |
$ | | $ | | $ | 2,882,258 | ||||||
Conversion of convertible preferred stock into common stock upon initial public offering |
$ | | $ | | $ | 43,515,677 | ||||||
Restricted assets, cash unrestricted upon conversion of convertible notes |
$ | | $ | | $ | 1,881,815 | ||||||
Supplemental disclosures of cash flow information: |
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Income taxes paid |
$ | 6,354 | $ | 10,952 | $ | 75,956 | ||||||
Interest paid |
$ | | $ | | $ | 2,487,343 |
See accompanying notes.
5
MEDICINOVA, INC.
(a development stage company)
Notes to Consolidated Financial Statements
(Unaudited)
1. Interim Financial Information
The Company
We were incorporated in the state of Delaware in September 2000. We are a development stage biopharmaceutical company focused on acquiring and developing novel, small molecule therapeutics for the treatment of serious diseases with unmet medical needs with a specific focus on the U.S. market. We are currently focusing our development activities on MN-166, a drug candidate for the treatment of neurological disorders, and on MN-221, a drug candidate for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease, or COPD.
Basis of Presentation
We have prepared the accompanying unaudited consolidated financial statements in accordance with accounting principles generally accepted in the U.S. for interim financial information. Accordingly, they do not include all of the information and disclosures required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments of a normal recurring nature necessary for the fair presentation of our financial position, results of operations and cash flow for the interim periods presented have been included. Operating results for the three and nine months ended September 30, 2013 are not necessarily indicative of the results that may be expected for the year ending December 31, 2013 or for any other period. For further information, see the financial statements and disclosures thereto for the year ended December 31, 2012 in our Annual Report on Form 10-K as filed with the Securities and Exchange Commission on March 28, 2013.
Principles of Consolidation
The consolidated financial statements include the accounts of MediciNova, Inc. and its wholly-owned subsidiaries. MediciNova, Inc. and its subsidiaries are collectively referred to herein as we, our or us.
On December 13, 2006, MediciNova (Europe) Limited, a wholly-owned subsidiary of MediciNova, Inc., was incorporated under the laws of England and Wales and established for the purpose of facilitating the clinical development of our product candidates for the European marketplace. MediciNova (Europe) Limiteds functional currency is the U.S. dollar, the reporting currency of its parent.
On January 4, 2007, MediciNova Japan, Inc., a wholly-owned subsidiary of MediciNova, Inc., was incorporated under the laws of Japan and established to strengthen business development and investor and public relations activities in Japan and other Asian countries. MediciNova Japan, Inc.s functional currency is the Japanese yen.
On December 18, 2009, Avigen, Inc. was acquired by and became a wholly-owned subsidiary of MediciNova, Inc. Avigen, Inc.s functional currency is the U.S. dollar.
All intercompany transactions and investments in our subsidiaries have been eliminated in consolidation.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results may differ from these estimates.
6
Revenue Recognition and Deferred Revenue
In October 2011, we entered into an agreement with Kissei Pharmaceutical Co., Ltd., or Kissei, to perform research and development services relating to MN-221 in exchange for a non-refundable upfront payment of $2.5 million. We assessed the deliverables in accordance with the authoritative guidance and concluded the existence of one deliverable, which was research and development services. Under the terms of the agreement, we are responsible for all costs to be incurred in the performance of these services. Certain of these research and development services were completed in 2012 and the remaining services are expected to be completed after 2014. We are recognizing the $2.5 million payment as revenue as the research and development services are performed. The amount received from Kissei, net of the amount recorded as revenue to date, is included on the balance sheet as deferred revenue and will be recognized as revenue as we perform the remaining services. For the three months ended September 30, 2013 and 2012, revenue recorded was $0 and $0.1 million, respectively. For the nine months ended September 30, 2013 and 2012, revenue recorded was approximately $3 thousand and $0.8 million, respectively.
Concentrations and Credit Risk
We maintain cash balances at various financial institutions and such balances commonly exceed the $250,000 insured amount by the Federal Deposit Insurance Corporation. We also maintain money market funds at various financial institutions which are not federally insured, although they are invested primarily in U.S. government securities. We have not experienced any losses in such accounts and management believes that we do not have significant credit risk with respect to such cash and cash equivalents.
2. Joint Venture
We entered into an agreement to form a joint venture company with Zhejiang Medicine Co., Ltd. and Beijing Make-Friend Medicine Technology Co., Ltd. effective September 27, 2011. In accordance with the joint venture agreement, in March 2012 we paid $680,000 for a 30% interest in Zhejiang Sunmy. The other parties to the joint venture agreement provided funding for their combined 70% interest and are responsible for future funding of Zhejiang Sunmys activities. Zhejiang Sunmy is a variable interest entity for which we are not the primary beneficiary as we do not have a majority of the board seats and we will not have power to direct or significantly influence the actions of the entity. We therefore account for the activities of Zhejiang Sunmy under the equity method whereby we absorb any loss or income generated by Zhejiang Sunmy according to our percentage ownership. At September 30, 2013 we reflect a long-term asset on our consolidated balance sheet which represents our investment in Zhejiang Sunmy, net of our portion of any generated loss or income.
3. Fair Value Measurements
As defined in the authoritative guidance for fair value measurements and disclosures under ASC 820, fair value is based on the price that would be received to sell an asset or would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase the comparability and consistency of fair value measurements, ASC 820 prescribes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels which are described below:
Level 1: | Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities at the measurement date. | |
Level 2: | Inputs are quoted prices for similar items in active markets or inputs are quoted prices for identical or similar items in markets that are not active. | |
Level 3: | Inputs are unobservable due to little or no market data availability and inputs are usually developed by management or a third-party which reflect those inputs that a market participant would use. The fair value hierarchy gives the lowest priority to Level 3 inputs. |
7
The following table presents our financial instruments measured at fair value on a recurring basis classified by the fair value measurements and disclosures valuation hierarchy (in thousands):
As of September 30, 2013 | ||||||||||||||||
Fair Value Measurements Using | ||||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||||
Cash equivalents |
$ | 699 | $ | 699 | $ | | $ | | ||||||||
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As of December 31, 2012 | ||||||||||||||||
Fair Value Measurements Using | ||||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||||
Cash equivalents |
$ | 1,720 | $ | 1,720 | $ | | $ | | ||||||||
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At September 30, 2013, cash equivalents (instruments with maturities of three months or less at the date of purchase) were primarily invested in money market accounts, the fair value of which is based on Level 1 criteria in which their carrying amount is a reasonable estimate of their fair value based on daily quoted market prices. At September 30, 2013 and December 31, 2012 we did not hold financial instruments measured at fair value on a non-recurring basis.
4. Net Loss Per Share
Net loss per common share is presented as basic and diluted net loss per common share. Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period using the treasury-stock method. For purposes of this calculation, convertible preferred stock, stock options and warrants are considered to be common stock equivalents and are only included in the calculation of diluted net loss per common share when their effect is dilutive.
Potentially dilutive outstanding securities excluded from diluted net loss per common share because of their anti-dilutive effect consist of the following:
September 30, | ||||||||
2013 | 2012 | |||||||
Convertible preferred stock, as converted |
2,200,000 | 2,200,000 | ||||||
Stock options |
2,904,137 | 3,328,981 | ||||||
Warrants |
3,876,067 | 3,128,686 | ||||||
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Total |
8,980,204 | 8,657,667 | ||||||
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5. Balance Sheet Details
Accrued Expenses
Accrued expenses consist of the following:
September 30, 2013 |
December 31, 2012 |
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Research and development costs |
$ | 118,197 | $ | 152,046 | ||||
Professional services fees |
183,198 | 68,102 | ||||||
Other |
171,031 | 94,504 | ||||||
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$ | 472,426 | $ | 314,652 | |||||
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8
6. Stock-Based Compensation
For the three months ended September 30, 2013 and 2012, stock-based compensation expense related to stock options and the employee stock purchase plan was approximately $198,000 and $179,000, respectively, and was recorded as a component of general and administrative expense (approximately $128,000 and $111,000, respectively) and research and development expense (approximately $70,000 and $68,000, respectively). For the nine months ended September 30, 2013 and 2012, stock-based compensation expense related to stock options and the employee stock purchase plan was approximately $719,000 and $540,000, respectively, and was recorded as a component of general and administrative expense (approximately $455,000 and $325,000, respectively) and research and development expense (approximately $264,000 and $215,000, respectively). During the three months ended September 30, 2013 and 2012, there were no options exercised. During the nine months ended September 30, 2013 and 2012, 79,462 and 60,000 stock options, respectively, were exercised from which proceeds of approximately $194,000 and $138,000, respectively, were received. As of September 30, 2013, there was $1.3 million of unamortized compensation expense related to unvested stock option awards which is expected to be recognized over a remaining weighted-average vesting period of 1.69 years.
During the three and nine months ended September 30, 2013, options to purchase 0 and 867,500 shares of common stock were granted, respectively. During the three and nine months ended September 30, 2012, options to purchase 735,000 and 750,000 shares of common stock were granted, respectively. As stock-based compensation expense recognized in the accompanying consolidated statements of operations and comprehensive loss includes expense related to stock option awards ultimately expected to vest, such expense should be reduced for estimated forfeitures. The authoritative guidance for compensation expense requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. As forfeitures have been immaterial in the past and are expected to continue to be immaterial, we did not estimate any forfeitures during 2012, or during the nine months ended September 30, 2013. We adjust our stock-based compensation expense when any forfeitures occur.
The MediciNova, Inc. 2007 Employee Stock Purchase Plan, or ESPP, provides employees the right to purchase our common stock through payroll deductions (not to exceed 15% of each employees compensation) at the lower of 85% of fair market value at the beginning of or the end of each six-month offering period. For the three and nine months ended September 30, 2013, the number of shares of common stock issued under the ESPP was 14,184 and 30,251, respectively, and for the three and nine months ended September 30, 2012, the number of shares of common stock issued under the ESPP was 19,864 and 35,414, respectively. Shares of common stock available for future ESPP issuances at September 30, 2013 and 2012 were 234,327 and 249,578, respectively.
We use the Black-Scholes valuation model for determining the estimated fair value and the stock-based compensation for stock-based awards to employees. The following table provides the assumptions used in the Black-Scholes valuation model for the three and nine months ended September 30, 2013 and 2012. The ESPP assumptions for the three months ended September 30, 2013 and 2012 are actual amounts, and for the nine months ended September 30, 2013 and 2012 are weighted average amounts.
Three Months Ended September 30, 2013 |
Three Months Ended September 30, 2012 |
Nine Months Ended September 30, 2013 |
Nine Months Ended September 30, 2012 |
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Stock Options assumptions: |
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Risk-free interest rate |
0.70 | % | 0.62 | % | 0.80 | % | 0.62 | % | ||||||||
Expected volatility of common stock |
85.76 | % | 82.22 | % | 86.10 | % | 82.14 | % | ||||||||
Dividend yield |
0.0 | % | 0.0 | % | 0.0 | % | 0.0 | % | ||||||||
Expected term (in years) |
5.4 | 5.3 | 5.5 | 5.3 | ||||||||||||
ESPP assumptions: |
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Risk-free interest rate |
0.15 | % | 0.16 | % | 0.18 | % | 0.34 | % | ||||||||
Expected volatility of common stock |
91.60 | % | 74.34 | % | 91.55 | % | 75.52 | % | ||||||||
Dividend yield |
0.0 | % | 0.0 | % | 0.0 | % | 0.0 | % | ||||||||
Expected term (in years) |
0.5 | 0.5 | 0.5 | 0.5 |
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7. Income Taxes
In accordance with the authoritative guidance for income taxes under ASC 740, a deferred tax asset or liability is determined based on the difference between the financial statements and the tax basis of assets and liabilities as measured by the enacted tax rates, which will be in effect when these differences reverse. We provide a valuation allowance against net deferred assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized.
We recognize the impact of a tax position in the financial statements only if that position is more likely than not of being sustained upon examination by taxing authorities, based on the technical merits of the position. Our practice is to recognize interest and/or penalties related to income tax matters in income tax expense.
We are subject to income taxation in the U.S., California and foreign jurisdictions, of which currently no years are under examination. Our tax years for 2000 and forward are subject to examination by the U.S. and state tax authorities due to the carry-forward of unutilized net operating losses and research and development credits. During the three and nine months ended September 30, 2013 and 2012, income tax expense recognized related to intercompany service income earned by our Japanese subsidiary, MediciNova Japan, Inc.
8. Related Party Transactions
On May 9, 2013, we entered into a securities purchase agreement with certain accredited investors pursuant to which we agreed to sell to the investors 1,158,730 shares of our common stock and warrants to purchase an aggregate of 869,047 shares of our common stock (the Private Placement). The Private Placement closed on May 14, 2013. The Private Placement included our issuance of shares of common stock and a warrant to purchase shares of common stock to Fountain Erika LLC (Fountain Erika), an entity of which Tatsuo Izumi, a member of our board of directors, is a principal. Fountain Erikas acquisition of the shares of the our common stock and a warrant to purchase shares of our common stock was at an at the market price.
9. Commitments and Contingencies
Legal Proceedings
We are not involved in any material legal proceedings as of September 30, 2013. We may become involved in various disputes and legal proceedings which arise in the ordinary course of business or otherwise. Our assessment of the likely impact of any pending litigation may change over time. An adverse result in any litigation matter may occur which could harm our business and result in a material liability.
10. Stockholders Equity
Stock Options
We have granted stock options to our employees, officers, directors and consultants under the MediciNova, Inc. Amended and Restated 2004 Stock Incentive Plan, and future stock option grants will be made under the MediciNova, Inc. 2013 Equity Incentive Plan. A summary of the changes in stock options outstanding during the nine months ended September 30, 2013 is as follows:
Stock Options |
Weighted Average Exercise Price |
|||||||
Outstanding at December 31, 2012 |
3,328,981 | $ | 4.92 | |||||
Granted |
867,500 | 2.83 | ||||||
Exercised |
79,462 | 2.44 | ||||||
Cancelled |
1,212,882 | 2.99 | ||||||
|
|
|||||||
Outstanding at September 30, 2013 |
2,904,137 | $ | 5.55 | |||||
|
|
|||||||
Exercisable at September 30, 2013 |
2,103,865 | $ | 6.22 |
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The aggregate intrinsic values of stock options outstanding, options exercised and options exercisable at September 30, 2013 were approximately $132,000, $64,000 and $116,000, respectively. The weighted average contractual life of options outstanding at September 30, 2013 was 6.5 years and the weighted average contractual life of exercisable options at September 30, 2013 was 5.5 years.
Kissei Stock Purchase
In October 2011, pursuant to a stock purchase agreement by and between us and Kissei, Kissei purchased for $7.5 million (i) an aggregate of 800,000 shares of our common stock, par value $0.001 per share, at a price of $2.50 per share, which approximated the fair value of our common stock at the time of the transaction, and (ii) 220,000 shares of our Series B Convertible Preferred Stock, or Series B Preferred, par value $0.01 per share, at a price of $25.00 per share, which approximated the fair value of our preferred stock on an as converted basis at the time of the transaction. The purchase agreement contains customary representations, warranties and covenants and a standstill agreement from Kissei that terminates if Kissei beneficially owns less than three percent of our outstanding voting stock. Each share of the Series B Preferred is convertible into 10 shares of common stock. The Series B Preferred ranks pari passu (on an as-if-converted-to-common-stock basis) with the common stock in liquidation and dividend rights. The holders of the Series B Preferred do not have voting rights, however the consent of the holders of a majority of the outstanding Series B Preferred is required for certain actions.
Common Stock Purchase Agreement
On August 20, 2012, we entered into a common stock purchase agreement with Aspire Capital Fund LLC, or Aspire, pursuant to which we could sell our common stock to Aspire from time to time up to an aggregate of $20 million of our common stock over the two-year term of the agreement, including $1 million in common stock purchased by Aspire in connection with execution of the agreement. No more than 3,231,096 shares of our common stock could be issued under this agreement, including 363,636 shares initially issued to Aspire in consideration of entering into the agreement. We could on any business day over the term of the agreement direct Aspire to purchase up to 50,000 shares, to a maximum of $500,000 per business day with a purchase price of the lower of the lowest sale price of our common stock on the date of the sale, or the average of the three lowest closing stock prices during the 12 consecutive business days ending on the business day immediately preceding the purchase date. In addition, we could on any business day over the term of the Agreement direct Aspire to make a volume-weighted average purchase (VWAP) of stock not to exceed 15% (which limitation may be increased up to 30% by the mutual agreement of the parties) of the aggregate shares of our stock traded on the next business day, the purchase price of which would be the lower of the closing price on the date of the sale, or 95% of the next business days NASDAQ volume weighted average price, subject to a minimum market price threshold established by us and certain other exceptions. In addition to the initial issuance of shares, as of September 30, 2013 we had completed sales to Aspire totaling 2,504,532 shares of common stock at prices ranging from $1.60 to $3.82 per share, generating gross proceeds of $5.4 million. See Notes to Consolidated Financial Statements - Note 11. Subsequent Events regarding termination of the common stock purchase agreement with Aspire subsequent to September 30, 2013.
Issuance of Warrant
On August 22, 2012, we issued a warrant in exchange for investor relations services to purchase up to 130,000 shares of our common stock at a price of $1.88 per share, the closing price of our common stock on that date. The warrant contains provisions whereby the warrant becomes exercisable for specified shares of our common stock as a result of our stock achieving certain share price targets within a 15 month period beginning on August 22, 2012. The warrant expires in five years. The warrant is valued at its fair value of approximately $0.1 million on August 22, 2012, was classified as equity and as a prepaid expense and amortized over the one-year period beginning August 22, 2012.
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Exercise of Warrants
During the three months ended September 30, 2013, no warrants were exercised. During the nine months ended September 30, 2013, warrants to purchase 121,666 shares of common stock related to the March 23, 2011 public offering of 2,750,000 units, with each unit consisting of one share of common stock and a warrant to purchase one share of common stock, were exercised generating proceeds of $0.4 million. No warrants were exercised during the three and nine months ended September 30, 2012
At-The-Market Equity Distribution Agreement
On April 17, 2013, we entered into an at-the-market equity distribution agreement with Macquarie Capital (USA) Inc., or MCUSA, pursuant to which we could sell our common stock through MCUSA from time to time up to an aggregate offering price of $6 million. Under the terms of the agreement, no daily sale of an amount of shares of our common stock was to exceed the lower of $50,000 or 10% of the lower of the 5-day or 3-month average daily traded value of our common stock as of the date of the applicable issuance notice. The price per share was not to be less than the greater of $1.19 or the last available closing price of a share of common stock on The NASDAQ Global Market (NASDAQ). MCUSA agreed to use its commercially reasonable efforts consistent with its customary trading and sales practices and applicable laws, rules and regulations to sell shares of our common stock and was to sell such shares by any method permitted by law deemed to be at the market. We agreed to pay MCUSA an aggregate commission rate of 8.0% of the gross proceeds of any common stock sold under the agreement. As of September 30, 2013, we had completed all available sales to MCUSA under this agreement generating gross and net proceeds of $6.0 million and $5.5 million, respectively, on sales of 1,936,237 shares of common stock at prices ranging from $2.44 to $4.10 per share.
See Notes to Consolidated Financial Statements - Note 11. Subsequent Events regarding a second at-the-market equity distribution agreement executed with MCUSA subsequent to September 30, 2013.
Securities Purchase Agreement
On May 9, 2013, we entered into a securities purchase agreement with certain accredited investors (the Purchase Agreement) pursuant to which we agreed to sell to the investors 1,158,730 shares of our common stock at a price of $3.15 per share and warrants to purchase an aggregate of 869,047 shares of our common stock with an exercise price of $3.15 per share (the Private Placement). The Private Placement closed on May 14, 2013. The warrants will expire on May 9, 2018 and may be exercised for cash or, if the current market price of our common stock is greater than the per share exercise price, by surrender of a portion of the warrant in a cashless exercise. The aggregate purchase price for the shares and the warrants sold in the Private Placement was $3.7 million and associated expenses incurred were $0.3 million. The Purchase Agreement includes representations, warranties, covenants and closing conditions customary for transactions of this type.
In connection with the purchase by an affiliated investor of 158,730 shares of our common stock and a warrant to purchase 119,047 shares of our common stock, on May 29, 2013 the investor provided $51,389 additional consideration for the shares and the warrant, and we amended the warrant to reflect an exercise price of $3.38 per share.
We allocated the net proceeds for the shares and the warrants sold in the Private Placement of $3.4 million based on the relative fair value of each instrument. We determined the fair value of the shares based on the closing price of our common stock on May 9, 2013, and the fair value of the warrants based on a Black-Scholes valuation model.
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11. Subsequent Events
At-The-Market Equity Distribution Agreement
On October 16, 2013, we entered into a second at-the-market equity distribution agreement with MCUSA pursuant to which we may sell our common stock through MCUSA from time to time up to an aggregate offering price of $10 million. Under the terms of this agreement, unless otherwise mutually agreed, no daily sale of an amount of shares of our common stock is to exceed the lower of $50,000 or 10% of the lower of the 5-day or 3-month average daily traded value of our common stock on NASDAQ (unless 10% of the lower of the 5-day or 3-month average daily traded value of our common stock on the JASDAQ Market of the Tokyo Securities Exchange (TSE) is greater, in which case the value from the TSE will be used) as of the date of the applicable issuance notice. The price per share is not to be less than the greater of $1.29 or the last available closing price of a share of common stock on NASDAQ. MCUSA agreed to use its commercially reasonable efforts consistent with its customary trading and sales practices and applicable laws, rules and regulations to sell shares of our common stock and is to sell such shares by any method permitted by law deemed to be at the market. We agreed to pay MCUSA an aggregate commission rate of 7.0% of the gross proceeds of any common stock sold under this agreement. MCUSA is under no obligation to purchase shares pursuant to this agreement and there are no assurances that MCUSA will be successful in selling shares. Our proceeds will depend on the number of shares of our common stock sold to MCUSA and the per share purchase price of each transaction. The agreement with MCUSA provides both MCUSA and us the right to terminate the agreement in our sole discretion upon giving five business days written notice. Through November 5, 2013, we have generated gross and net proceeds of $51.0 thousand and $47.4 thousand, respectively, under this agreement on sales of 20,000 shares of our common stock at prices ranging from $2.52 to $2.58 per share.
Common Stock Purchase Agreement
We made no sales of our common stock to Aspire subsequent to September 30, 2013, and we terminated the common stock purchase agreement with Aspire on October 17, 2013.
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ITEM 2. | MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. |
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and notes thereto included in this Quarterly Report on Form 10-Q and the audited financial statements and notes thereto as of and for the year ended December 31, 2012 included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 28, 2013. Past operating results are not necessarily indicative of results that may occur in future periods.
This Quarterly Report on Form 10-Q contains forward-looking statements that are subject to risks and uncertainties, many of which are beyond our control. Our actual results may differ from those anticipated in these forward-looking statements as a result of various factors, including those set forth in Part II of this Quarterly Report on Form 10-Q under the caption Item 1A. Risk Factors and under the caption Item 1A. Risk Factors in our Annual Report on Form 10-K., The differences may be material. Forward-looking statements discuss matters that are not historical facts. Forward-looking statements include, but are not limited to, statements regarding our plans, strategies, objectives, product development programs, clinical trials, industry, financial condition, liquidity and capital resources, future performance and other statements that are not historical facts. Such forward-looking statements include statements preceded by, followed by or that otherwise include the words may, might, will, intend, should, could, can, would, expect, believe, estimate, anticipate, predict, potential, plan or similar words. For such statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You should not rely unduly on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.
Overview and Recent Developments
We are a development stage biopharmaceutical company focused on acquiring and developing novel, small molecule therapeutics for the treatment of serious diseases with unmet medical needs with a commercial focus on the U.S. market. We are currently focusing our development activities on MN-166, a drug candidate for the treatment of neurological disorders, and on MN-221, a drug candidate for the treatment of acute exacerbations of asthma and COPD.
We have incurred significant net losses since our inception. We incurred losses of $7.4 million for the nine months ended September 30, 2013, and at September 30, 2013 our accumulated deficit is $303.7 million, including $51.1 million of non-cash stock-based compensation charges. We expect to incur substantial net losses for the next several years as we continue to develop certain of our existing product development programs, and we may incur substantial net losses over the long-term if we expand our research and development programs and/or acquire products, technologies or businesses that are complementary to our own. As of September 30, 2013, we had available cash and cash equivalents of $10.7 million and working capital of $9.9 million. While there can be no assurances given, we believe our working capital at September 30, 2013 will be sufficient to fund our operations for at least the next 12 months, assuming that we operate our business in accordance with our current operating plan. This belief is based on assumptions that could prove to be wrong, and we could utilize our available working capital sooner than we currently expect.
Between August 20, 2012 and September 30, 2013 we completed sales totaling 2,504,532 shares of common stock and generated net proceeds of $5.4 million under the common stock purchase agreement with Aspire Capital Fund LLC, or Aspire. We have made no sales of our common stock to Aspire subsequent to September 30, 2013 and we terminated the common stock purchase agreement with Aspire on October 17, 2013. Between April 17, 2013 and September 30, 2013, we completed all available sales totaling 1,936,237 shares of common stock and generated gross and net proceeds of $6.0 million and $5.5 million, respectively, under the
14
at-the-market equity distribution agreement with Macquarie Capital (USA) Inc., or MCUSA. On May 14, 2013, we closed a private placement which generated gross proceeds of $3.7 million through the sale of 1,158,730 shares of our common stock and warrants to purchase 750,000 and 119,047 shares of our common stock with an exercise price of $3.15 per share and $3.38 per share, respectively. Expenses incurred related to this transaction were $0.3 million. On October 16, 2013, we entered into a second at-the-market equity distribution agreement with MCUSA pursuant to which we may from time to time sell through MCUSA shares of our common stock up to an aggregate offering price of $10 million. Through November 5, 2013, we have generated gross and net proceeds of $51.0 thousand and $47.4 thousand, respectively, under this agreement on sales of 20,000 shares of our common stock.
We may pursue other opportunities to raise capital in the future. There can be no assurances that there will be adequate financing available to us on acceptable terms, or at all. If we are unable to obtain additional financing, we may have to sell one or more of our programs or cease operations.
Kissei Stock Purchase
In October 2011, pursuant to a stock purchase agreement by and between us and Kissei Pharmaceutical Co., Ltd., or Kissei, Kissei purchased for $7.5 million (i) an aggregate of 800,000 shares of our common stock, par value $0.001 per share, at a price of $2.50 per share, which approximated the fair value of our common stock at the time of the transaction, and (ii) 220,000 shares of our Series B Convertible Preferred Stock, or Series B Preferred, par value $0.01 per share, at a price of $25.00 per share, which approximated the fair value of our preferred stock on an as converted basis at the time of the transaction. The purchase agreement contains customary representations, warranties and covenants and a standstill agreement from Kissei that terminates if Kissei beneficially owned less than three percent of our outstanding voting stock. Each share of the Series B Preferred is convertible into 10 shares of common stock. The Series B Preferred ranks pari passu (on an as-if-converted-to-common-stock basis) with the common stock in liquidation and dividend rights. The holders of the Series B Preferred do not have voting rights, however the consent of the holders of a majority of the outstanding Series B Preferred is required for certain actions.
Kissei Services Agreement
In October 2011, we entered into an agreement with Kissei to perform research and development services relating to MN-221 in exchange for a non-refundable upfront payment of $2.5 million. We assessed the deliverables in accordance with the authoritative guidance and concluded the existence of one deliverable, which was research and development services. Under the terms of the agreement, we are responsible for all costs to be incurred in the performance of these services. Certain of these research and development services were completed in 2012 and the remaining services are expected to be completed after 2014. We are recognizing the $2.5 million payment as revenue as the research and development services are performed.
Common Stock Purchase Agreement
On August 20, 2012, we entered into a common stock purchase agreement with Aspire pursuant to which we could sell our common stock to Aspire from time to time up to an aggregate of $20 million of our common stock over the two-year term of the agreement, including $1 million in common stock purchased by Aspire in connection with execution of the agreement. No more than 3,231,096 shares of our common stock could be issued under this agreement, including 363,636 shares initially issued to Aspire in consideration of entering into the agreement. Our proceeds were dependent on the frequency and number of shares of our common stock sold to Aspire and the per share purchase price of each transaction. In addition to the initial issuance of shares, as of September 30, 2013 we had completed sales to Aspire totaling 2,504,532 shares of common stock at prices ranging from $1.60 to $3.82 per share, generating gross proceeds of $5.4 million. We have made no sales of our common stock to Aspire subsequent to September30, 2013 and we terminated the common stock purchase agreement with Aspire on October 17, 2013.
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At-The-Market Equity Distribution Agreements
On April 17, 2013, we entered into an at-the-market equity distribution agreement with MCUSA pursuant to which we could sell our common stock through MCUSA from time to time up to an aggregate offering price of $6 million. Under the terms of the agreement no daily sale of an amount of shares of our common stock was to exceed the lower of $50,000 or 10% of the lower of the 5-day or 3-month average daily traded value of our common stock as of the date of the applicable issuance notice. The price per share was not to be less than the greater of $1.19 or the last available closing price of a share of common stock on The NASDAQ Global Market (NASDAQ). MCUSA agreed to use its commercially reasonable efforts consistent with its customary trading and sales practices and applicable laws, rules and regulations to sell shares of our common stock and was to sell such shares by any method permitted by law deemed to be at the market. We agreed to pay MCUSA an aggregate commission rate of 8.0% of the gross proceeds of any common stock sold under the agreement. As of September 30, 2013, we had completed all available sales to MCUSA generating gross and net proceeds of $6.0 million and $5.5 million, respectively, on sales of 1,936,237 shares of common stock at prices ranging from $2.44 to $4.10 per share.
On October 16, 2013, we entered into a second at-the-market equity distribution agreement with MCUSA pursuant to which we may sell our common stock through MCUSA from time to time up to an aggregate offering price of $10 million. Under the terms of this agreement, unless otherwise mutually agreed, no daily sale of an amount of shares of our common stock is to be greater than the lower of $50,000 or 10% of the lower of the 5-day or 3-month average daily traded value of our common stock on NASDAQ (unless 10% of the lower of the 5-day or 3-month average daily traded value of our common stock on the JASDAQ Market of the Tokyo Securities Exchange (TSE) is greater, in which case the value from the TSE will be used) as of the date of the applicable issuance notice. The price per share is not to be less than the greater of $1.29 or the last available closing price of a share of common stock on NASDAQ. MCUSA agreed to use its commercially reasonable efforts consistent with its customary trading and sales practices and applicable laws, rules and regulations to sell shares of our common stock and is to sell such shares by any method permitted by law deemed to be at the market. We agreed to pay MCUSA an aggregate commission rate of 7.0% of the gross proceeds of any common stock sold under this agreement. MCUSA is under no obligation to purchase shares pursuant to this agreement and there are no assurances that MCUSA will be successful in selling shares. Our proceeds will depend on the number of shares of our common stock sold to MCUSA and the per share purchase price of each transaction. The agreement with MCUSA provides both MCUSA and us the right to terminate the agreement in our sole discretion upon giving five business days written notice.
Securities Purchase Agreement
On May 9, 2013, we entered into a securities purchase agreement with certain accredited investors (the Purchase Agreement) pursuant to which we agreed to sell to the investors 1,158,730 shares of our common stock and warrants to purchase an aggregate of 869,047 shares of our common stock with an exercise price of $3.15 per share (the Private Placement). The Private Placement closed on May 14, 2013. The warrants will expire on May 9, 2018 and may be exercised for cash or, if the current market price of our common stock is greater than the per share exercise price, by surrender of a portion of the warrant in a cashless exercise. The aggregate purchase price for the shares and the warrants sold in the Private Placement was $3.7 million and associated expenses incurred were $0.3 million. The Purchase Agreement includes representations, warranties, covenants and closing conditions customary for transactions of this type.
In connection with the purchase by an affiliated investor of 158,730 shares of our common stock and a warrant to purchase 119,047 shares of our common stock, on May 29, 2013 the investor provided $51,389 additional consideration for the shares and the warrant, and the investor and we amended the warrant to reflect an exercise price of $3.38 per share.
Lease of Corporate Headquarters
We leased office space at our headquarters at 4350 La Jolla Village Drive, Suite 950, San Diego, California under a lease that expired on February 28, 2013. On February 27, 2013, we entered into a sublease agreement
16
effective March 1, 2013 (the Sublease) with Denali Advisors, LLC, the sublessor. The Sublease is for our current headquarters located at 4275 Executive Square, Suite 650, La Jolla, California, 92037. The Sublease has a term of 4 years and 9 months and provides that we will pay Denali Advisors, LLC an initial monthly base rent of $10,699 for the premises, with monthly increases of $522 as of the 13th, 25th, 37th and 49th month.
Revenues and Cost of Revenues
For the three months ended September 30, 2013 and 2012, we recognized $0 and $0.1 million, respectively, and for the nine months ended September 30, 2013 and 2012, we recognized $3.3 thousand and $0.8 million, respectively, of revenue related to the Kissei services agreement based on the development services we performed during each period. To date through September 30, 2013 we have recognized approximately $806,000 of Kissei services revenue, and all expenses incurred related to these services have been recorded as research and development expenses. Other than the Kissei services revenue, our revenues to date have been from development services revenues under service agreements pursuant to which we billed consulting fees and our pass-through clinical contract costs.
Research and Development
Our research and development expenses consist primarily of the license fees related to our product candidates, salaries and related employee benefits, costs associated with the preclinical and clinical development of our product development programs, costs associated with non-clinical activities such as regulatory expenses, and pre-commercialization manufacturing activities. We use external service providers to manufacture our compounds to be used in clinical trials and for the majority of the services performed in connection with the preclinical and clinical development of our product candidates. Research and development expenses include fees paid to consultants, contract research organizations, contract manufacturers and other external service providers, including professional fees and costs associated with legal services, patents and patent applications for our intellectual property. Internal research and development expenses include costs of compensation and other expenses for research and development personnel, supplies, facility costs and depreciation. Research and development costs are expensed as incurred.
The following table summarizes our research and development expenses for the periods indicated for each of our product development programs. To the extent that costs, including personnel costs, are not tracked to a specific product development program, such costs are reflected as Unallocated (in thousands):
Product Candidate |
Three months ended September 30, |
Nine months ended September 30, |
||||||||||||||||
Product Development Program |
2013 | 2012 | 2013 | 2012 | ||||||||||||||
MN-166 |
Neurological disorders including opioid withdrawal, methamphetamine addiction, chronic MOH pain and MS | $ | 408 | $ | 154 | $ | 1,439 | $ | 471 | |||||||||
MN-221 |
Acute exacerbations of asthma/COPD | 45 | 673 | 174 | 3,185 | |||||||||||||
MN-001 |
Bronchial asthma | 57 | 9 | 93 | 164 | |||||||||||||
MN-029 |
Solid tumors | 8 | 26 | 26 | 90 | |||||||||||||
MN-001 |
Interstitial cystitis | 1 | | 5 | 34 | |||||||||||||
MN-305 |
Generalized anxiety disorder/insomnia | 12 | | 13 | 2 | |||||||||||||
MN-246 |
Urinary incontinence | 1 | 1 | 2 | 6 | |||||||||||||
MN-447 |
Thrombotic disorders | | | | 6 | |||||||||||||
MN-462 |
Thrombotic disorders | | | | | |||||||||||||
Unallocated |
254 | 10 | 676 | 277 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total research and development |
$ | 786 | $ | 873 | $ | 2,428 | $ | 4,235 | ||||||||||
|
|
|
|
|
|
|
|
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We are currently focusing our development activities on MN-166, a drug candidate for the treatment of neurological disorders, and on MN-221, a drug candidate for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease, or COPD. Clinical development of MN-166 is ongoing in both methamphetamine addiction and opioid addiction with clinical trials being conducted by experts in both areas. A Phase 2 outpatient clinical trial of MN-166 in methamphetamine dependence, led by investigators at UCLA, has been funded by the National Institute of Drug Abuse, or NIDA. A second NIDA funded clinical trial of MN-166 in opioid abusers is currently ongoing with the investigators at Columbia University and the New York State Psychiatric Institute. In February 2013, we received Fast Track designation from the United States Food and Drug Administration, or FDA, for MN-166 in methamphetamine dependence. Fast Track designation is a process designed to facilitate development and expedite the review of drugs intended to treat serious diseases that have the potential to fill an unmet medical need. The FDAs Fast Track program emphasizes early and frequent communication between the FDA and the sponsor throughout the development process to improve product development efficiency, potentially leading to a shortened timeline to ultimate drug approval. A Phase 1b clinical trial of MN-166 in methamphetamine dependence at UCLA and funded by NIDA was completed in June, 2013, and a Phase 1b/2a clinical trial of MN-166 for the treatment of opioid withdrawal and analgesia led by investigators at Columbia University and New York State Psychiatric Institute and funded by NIDA was completed in 2010. In July, 2013 we announced the funding and regulatory approvals of a National Institute of Health, or NIH, based grant for a Phase 2b trial of MN-166 for patients with progressive multiple sclerosis. In August 2013 we announced that the National Institute on Alcohol Abuse and Alcoholism, or NIAAA, a part of the NIH, will fund a clinical trial of MN-166 for alcohol dependence to be conducted at UCLA. Regarding MN-221, future development is being considered according to feedback received from the FDA in October 2012.
We expect our research and development expenses related to the remainder of our existing product candidates to remain low in the foreseeable future as we continue to limit our expenditures on these product candidates to only those activities deemed necessary to maintain our license rights or to maximize their value.
General and Administrative
Our general and administrative costs primarily consist of salaries, benefits and consulting and professional fees related to our administrative, finance, human resources, business development, legal, information systems support functions, facilities and insurance costs. General and administrative costs are expensed as incurred.
Our general and administrative expenses may increase in future periods if we are required to expand our infrastructure based on the success of our product development programs or to raise additional capital to support our product development programs or otherwise in connection with increased business development activities related to partnering, out-licensing or product disposition.
Other Income and Expense
Other income primarily consists of interest earned on our cash and cash equivalents. Other expense primarily consists of losses from the joint venture and net foreign exchange gains and losses related to vendor invoices denominated in foreign currencies. We held no debt and had no interest expense in 2012 or in the nine months ended September 30, 2013.
Critical Accounting Policies and Estimates
Our managements discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements which have been prepared in accordance with principles generally accepted in the U.S. The preparation of the consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and the related disclosure of contingent liabilities. We review our estimates on an ongoing basis, including those related to our significant accruals. We base our estimates on historical experience and on various other assumptions that we
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believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates.
Our significant accounting policies and estimates are the same as those noted in our Annual Report on Form 10-K for the year ended December 31, 2012, as filed with the SEC on March 28, 2013.
Results of Operations
Comparison of the Three Months Ended September 30, 2013 and 2012
Revenues
Revenue for the three months ended September 30, 2013 was $0, a decrease of $0.1 million when compared to the three months ended September 30, 2012. The decrease in revenue was due to the completion of the Phase 1b/2a COPD clinical trial (MN 221-CL-012) in 2012 for which we recorded revenue related to the development services we performed under the Kissei services agreement.
Research and Development
Research and development expenses for the three months ended September 30, 2013 were $0.8 million, a decrease of $0.1 million when compared to $0.9 million for the three months ended September 30, 2012. This decrease in research and development expenses was due primarily to a decrease in spending on MN-221 development due to the completion of the CL-007 and CL-012 clinical trials in 2012, partially offset by an increase in spending on MN-166 development.
General and Administrative
General and administrative expenses for the three months ended September 30, 2013 were $1.5 million, a decrease of $0.1 million when compared to $1.6 million for the three months ended September 30, 2012. This decrease in general and administrative expenses was due primarily to a decrease in employee compensation and bonus expense.
Other Expense
Other expense for the three months ended September 30, 2013 was $0.4 thousand as compared to approximately $14 thousand for the three months ended September 30, 2012. Other expense consisted of losses from the joint venture accounted for under the equity method and net foreign exchange gains and losses related to vendor invoices denominated in foreign currencies.
Other Income
Other income for the three months ended September 30, 2013 was approximately $8 thousand as compared to approximately $4 thousand for the three months ended September 30, 2012. Other income consists of interest income on our cash equivalents.
Comparison of the Nine Months Ended September 30, 2013 and 2012
Revenues
Revenue for the nine months ended September 30, 2013 was $3.2 thousand, a decrease of $0.8 million when compared to $0.8 million for the nine months ended September 30, 2012. The decrease in revenue is due to the completion of the Phase 1b/2a COPD clinical trial (MN 221-CL-012) in 2012 for which we recorded revenue related to the development services we performed under the Kissei services agreement.
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Research and Development
Research and development expenses for the nine months ended September 30, 2013 were $2.4 million, a decrease of $1.8 million when compared to $4.2 million for the nine months ended September 30, 2012. This decrease in research and development expenses was due primarily to a decrease in spending on MN-221 development due to the completion of the CL-007 and CL-012 clinical trials in 2012, partially offset by an increase in spending on MN-166 development.
General and Administrative
General and administrative expenses for the nine months ended September 30, 2013 were $5.0 million, a decrease of $0.1 million when compared to $5.1 million for the nine months ended September 30, 2012. This decrease in general and administrative expenses was due primarily to a decrease in employee compensation and bonus expense.
Other Expense
Other expense for the nine months ended September 30, 2013 was approximately $6 thousand as compared to approximately $19 thousand for the nine months ended September 30, 2012. Other expense consisted of losses from the joint venture accounted for under the equity method and net foreign exchange gains and losses related to vendor invoices denominated in foreign currencies.
Other Income
Other income for the nine months ended September 30, 2013 was approximately $14 thousand as compared to approximately $22 thousand for the nine months ended September 30, 2012. Other income consists of interest income on our cash equivalents.
Liquidity and Capital Resources
We have incurred losses of $2.2 million and $7.4 million for the three and nine months ended September 30, 2013, and $11.0 million for the year ended December 31, 2012. At September 30, 2013 our accumulated deficit was $303.7 million including $51.1 million of non-cash stock-based compensation charges. We have used net cash of $6.6 million and $11.9 million to fund our operating activities for the nine months ended September 30, 2013 and for the year ended December 31, 2012, respectively. Our operating losses to date have been funded primarily through the private placement of our equity securities, the public sale of our common stock, long-term debt, development agreements with partners and the exercise of warrants. As of September 30, 2013, we had available cash and cash equivalents of $10.7 million and working capital of $9.9 million.
In October 2011, pursuant to a stock purchase agreement by and between us and Kissei, Kissei purchased (i) an aggregate of 800,000 shares of our common stock, par value $0.001 per share, at a price of $2.50 per share, and (ii) 220,000 shares of our Series B Preferred, par value $0.01 per share, at a price of $25.00 per share. We received gross proceeds of $7.5 million related to this purchase agreement.
In October 2011, we entered into an agreement with Kissei to perform research and development services relating to MN-221 in exchange for a non-refundable upfront payment of $2.5 million. We are responsible for all costs incurred and to be incurred in the performance of these services. The amount received from Kissei, net of the amount recorded as revenue to date, is included on the balance sheet as deferred revenue and will be recognized as revenue as we perform the remaining services. At September 30, 2013, our deferred revenue was $1.7 million and was classified entirely as long-term.
On August 20, 2012, we entered into a common stock purchase agreement with Aspire, pursuant to which we could sell our common stock to Aspire from time to time up to an aggregate of $20 million of our common stock over the two-year term of the agreement including $1 million in common stock purchased by Aspire in
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connection with execution of the agreement. No more than 3,231,096 shares of our common stock could be issued under this agreement, including 363,636 shares initially issued to Aspire in consideration of entering into the agreement. We could on any business day over the term of the agreement direct Aspire to purchase up to 50,000 shares, to a maximum of $500,000 per business day with a purchase price of the lower of the lowest sale price of our common stock on the date of the sale, or the average of the three lowest closing stock prices during the 12 consecutive business days ending on the business day immediately preceding the purchase date. In addition, we could on any business day over the term of the agreement direct Aspire to make a volume-weighted average purchase (VWAP) of stock not to exceed 15% (which limitation may be increased up to 30% by the mutual agreement of the parties) of the aggregate shares of our stock traded on the next business day, the purchase price of which shall be the lower of the closing price on the date of the sale, or 95% of the next business days NASDAQ volume weighted average price, subject to a minimum market price threshold established by us and certain other exceptions. Between August 20, 2012 and September 30, 2013, we generated gross proceeds of $5.4 million under this agreement. We have made no sales of our common stock to Aspire subsequent to September 30, 2013 and we terminated the common stock purchase agreement with Aspire on October 17, 2013.
On April 17, 2013, we entered into an at-the-market equity distribution agreement with MCUSA pursuant to which we could sell our common stock through MCUSA from time to time up to an aggregate offering price of $6 million. Under the terms of the agreement, no daily sale of an amount of shares of our common stock was to exceed the lower of $50,000 or 10% of the lower of the 5-day or 3-month average daily traded value of our common stock as of the date of the applicable issuance notice. The price per share may not be less than the greater of $1.19 or the last available closing price of a share of common stock on NASDAQ. MCUSA agreed to use its commercially reasonable efforts consistent with its customary trading and sales practices and applicable laws, rules and regulations to sell shares of our common stock and may sell such shares by any method permitted by law deemed to be at the market. We agreed to pay MCUSA an aggregate commission rate of 8.0% of the gross proceeds of any common stock sold under the agreement. Between April 17, 2013 and September 30, 2013, we completed all available sales totaling 1,936,237 shares of common stock and generated gross and net proceeds of $6.0 million and $5.5 million, respectively, under the agreement with MCUSA.
On May 9, 2013, we entered into a securities purchase agreement with certain accredited investors (the Purchase Agreement) pursuant to which we agreed to sell to the investors 1,158,730 shares of our common stock at a price of $3.15 per share and warrants to purchase an aggregate of 869,047 shares of our common stock with an exercise price of $3.15 per share (the Private Placement). The Private Placement closed on May 14, 2013. The warrants will expire on May 9, 2018 and may be exercised for cash or, if the current market price of our common stock is greater than the per share exercise price, by surrender of a portion of the warrant in a cashless exercise. The aggregate purchase price for the shares and the warrants sold in the Private Placement was $3.7 million and associated expenses incurred were $0.3 million. The Purchase Agreement includes representations, warranties, covenants and closing conditions customary for transactions of this type. In connection with the purchase by an affiliated investor of 158,730 shares of our common stock and a warrant to purchase 119,047 shares of our common stock, on May 29, 2013 the investor provided $51,389 additional consideration for the shares and the warrant, and the investor and we amended the warrant to reflect an exercise price of $3.38 per share.
On October 16, 2013, we entered into a second at-the-market equity distribution agreement with MCUSA pursuant to which we may sell our common stock through MCUSA from time to time up to an aggregate offering price of $10 million. Under the terms of this agreement, unless otherwise mutually agreed, no daily sale of an amount of shares of our common stock is to be greater than the lower of $50,000 and 10% of the lower of the 5-day or 3-month average daily traded value of our common stock on NASDAQ (unless 10% of the lower of the 5-day or 3-month average daily traded value of our common stock on the TSE is greater, in which case the value from the TSE will be used) as of the date of the applicable issuance notice. The price per share is not to be less than the greater of $1.29 or the last available closing price of a share of common stock on NASDAQ. MCUSA agreed to use its commercially reasonable efforts consistent with its customary trading and sales practices and applicable laws, rules and regulations to sell shares of our common stock and is to sell such shares by any
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method permitted by law deemed to be at the market. We agreed to pay MCUSA an aggregate commission rate of 7.0% of the gross proceeds of any common stock sold under this agreement. MCUSA is under no obligation to purchase shares pursuant to this agreement and there are no assurances that MCUSA will be successful in selling shares. Our proceeds will depend on the number of shares of our common stock sold to MCUSA and the per share purchase price of each transaction. The agreement with MCUSA provides both MCUSA and us the right to terminate the agreement in our sole discretion upon giving five business days written notice.
Our current cash and cash equivalents are our principal sources of liquidity. We utilize our cash and cash equivalents to fund our operations, including research and development of our product development candidates and clinical trials. As of September 30, 2013, we had available cash and cash equivalents of $10.7 million and working capital of $9.9 million. While there can be no assurances given, we believe our working capital at September 30, 2013 will be sufficient to fund our operations for at least the next 12 months, assuming that we operate our business in accordance with our current operating plan. This belief is based on assumptions that could prove to be wrong, and we could utilize our available working capital sooner than we currently expect. We have had, and continue to have, an ongoing need to raise additional cash from outside sources to fund our operations. We have a history of raising capital through equity and debt, and management plans to continue its efforts to finance operations with equity issuances, debt arrangements, or a combination thereof. If adequate funds are not available, we might be required to delay, reduce the scope of or terminate one or more of our product development programs and/or implement other operating cost reductions, any of which could result in the termination of license rights related to any of our product candidates.
Because of various risks and uncertainties associated with development and commercialization of our products, we are unable to estimate the amount of our future working capital requirements. These requirements will depend on many factors, including, but not limited to:
| progress in, and the costs of, future planned clinical trials and other research and development activities; |
| the scope, prioritization and number of our product development programs; |
| our obligations under our license agreements, pursuant to which we may be required to make future milestone payments upon the achievement of various milestones related to clinical, regulatory or commercial events; |
| our ability to establish and maintain strategic collaborations, including licensing and other arrangements, and to complete acquisitions of additional product candidates; |
| the time and costs involved in obtaining regulatory approvals; |
| the costs of securing manufacturing arrangements for clinical or commercial production of our product candidates; |
| the costs associated with expanding our management, personnel, systems and facilities; |
| the costs associated with any litigation; |
| the costs associated with the operations or wind-down of any business we may acquire; |
| the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; and |
| the costs of establishing or contracting for sales and marketing capabilities and commercialization activities if we obtain regulatory approval to market our product candidates. |
Off-Balance Sheet Arrangements
At September 30, 2013, we did not have any relationship with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance variable interest, or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements. In addition, we
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did not engage in trading activities involving non-exchange traded contracts. As a result, we are not exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in such relationships. We do not have relationships and transactions with persons and entities that derive benefits from their non-independent relationship with us or our related parties except as disclosed herein.
ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. |
Our primary exposure to market risk due to changes in interest rates relates primarily to the increase or decrease in the amount of interest income we can earn on our investment portfolio. The primary objective of our investment activities is to preserve principal. Our risk associated with fluctuating interest rates is limited to our investments in interest rate sensitive financial instruments and we do not use interest rate derivative instruments to manage exposure to interest rate changes. We mitigate default risk by investing in investment grade securities. A hypothetical 100 basis point adverse move in interest rates along the entire interest rate yield curve would not materially affect the fair value of our interest sensitive financial instruments due to their relatively short term nature.
Cash and cash equivalents as of September 30, 2013 were $10.7 million and were primarily invested in money market interest bearing accounts and money market funds. A hypothetical 10% adverse change in the average interest rate on our cash and cash equivalents would have had no material effect on net loss for the nine months ended September 30, 2013.
ITEM 4. | CONTROLS AND PROCEDURES. |
We maintain disclosure controls and procedures that are designed to provide reasonable assurance that the information required to be disclosed in our filings under the Securities Exchange Act of 1934, as amended, or the Exchange Act, is (1) recorded, processed, summarized and reported within the time periods specified in SECs rules and forms, and (2) accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure.
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our procedures or our internal controls will prevent or detect all errors and all fraud. Any internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of our controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.
Evaluation of Disclosure Controls and Procedures
As required by Rule 13a-15(b) of the Exchange Act, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the quarter covered by this report. Based on the foregoing, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There has been no change in our internal control over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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ITEM 1. | LEGAL PROCEEDINGS. |
We are not involved in any material legal proceedings as of September 30, 2013. We may become involved in various disputes and legal proceedings which arise in the ordinary course of business or otherwise. While it is not possible to accurately predict or determine the outcome of these matters, an adverse result in any litigation matter may occur which could harm our business.
ITEM 1A. | RISK FACTORS. |
In addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2012, which are incorporated herein by reference and which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results. There have been no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2012 other than the addition of the following risk factor:
The sale of additional common stock to Macquarie Capital (USA) Inc.) may cause substantial dilution to our existing shareholders and/or the price of our common stock to decline.
Pursuant to the at-the-market equity distribution agreement with MCUSA dated October16, 2013, we may sell additional shares of our common stock to MCUSA. Depending upon market liquidity at the time, sales of shares of our common stock under the agreement may cause the trading price of our common stock to decline and may result in substantial dilution to the interests of other holders of our common stock. The sale of a substantial number of shares of our common stock to MCUSA, or anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.
ITEM 6. | EXHIBITS. |
Exhibit |
Description | |
10.1 | Severance Agreement and Release, dated as of September 25, 2013, by and between the Registrant and Kirk Johnson, Ph.D. (incorporated by reference to Exhibit 10.1 to the Registrants Current Report on Form 8-K filed September 26, 2013). | |
10.2 | Equity Distribution Agreement between the Registrant and Macquarie Capital (USA) Inc., dated October 16, 2013 (incorporated by reference to Exhibit 10.1 to the Registrants Current Report on From 8-K filed October 16, 2013). | |
10.3 | Form of Notice of Stock Option Grant and Stock Option Agreement for awards pursuant to the 2013 Equity Incentive Plan. | |
31.1 | Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the period ended September 30, 2013. | |
31.2 | Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the period ended September 30, 2013. | |
32.1 | Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350 (Section 906 of the Sarbanes-Oxley Act of 2002). | |
32.2 | Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350 (Section 906 of the Sarbanes-Oxley Act of 2002). |
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Exhibit |
Description | |
101 | The following financial statements from the MediciNova, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 formatted in Extensible Business Reporting Language (XBRL): (i) Consolidated Balance Sheets; (ii) Consolidated Statements of Operations and Comprehensive Loss; (iii) Consolidated Statements of Cash Flows; and (iv) the notes to the consolidated financial statements. |
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Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
MEDICINOVA, INC. | ||||||
Date: November 7, 2013 | By: | /S/ YUICHI IWAKI | ||||
Yuichi Iwaki, M.D., Ph.D. President and Chief Executive Officer (on behalf of the registrant and as the registrants Principal Executive Officer) | ||||||
By: | /S/ MICHAEL GENNARO | |||||
Michael Gennaro Chief Financial Officer (on behalf of the registrant and as the registrants Principal Financial Officer) |
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INDEX TO EXHIBITS
Exhibit |
Description | |
10.1 | Severance Agreement and Release, dated as of September 25, 2013, by and between the Registrant and Kirk Johnson, Ph.D. (incorporated by reference to Exhibit 10.1 to the Registrants Current Report on Form 8-K filed September 26, 2013). | |
10.2 | Equity Distribution Agreement between the Registrant and Macquarie Capital (USA) Inc., dated October 16, 2013 (incorporated by reference to Exhibit 10.1 to the Registrants Current Report on From 8-K filed October 16, 2013). | |
10.3 | Form of Notice of Stock Option Grant and Stock Option Agreement for awards pursuant to the 2013 Equity Incentive Plan. | |
31.1 | Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the period ended September 30, 2013. | |
31.2 | Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the period ended September 30, 2013. | |
32.1 | Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350 (Section 906 of the Sarbanes-Oxley Act of 2002). | |
32.2 | Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350 (Section 906 of the Sarbanes-Oxley Act of 2002). | |
101 | The following financial statements from the MediciNova, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 formatted in Extensible Business Reporting Language (XBRL): (i) Consolidated Balance Sheets; (ii) Consolidated Statements of Operations and Comprehensive Loss; (iii) Consolidated Statements of Cash Flows; and (iv) the notes to the consolidated financial statements. |
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Exhibit 10.3
MEDICINOVA, INC.
STOCK OPTION GRANT NOTICE
(2013 EQUITY INCENTIVE PLAN)
MediciNova, Inc. (the Company), pursuant to its 2013 Equity Incentive Plan (the Plan), hereby grants to Optionholder an option to purchase the number of shares of the Companys Common Stock set forth below. This option is subject to all of the terms and conditions as set forth in this Stock Option Grant Notice (this Grant Notice), in the Option Agreement, the Plan and the Notice of Exercise, all of which are attached hereto and incorporated herein in their entirety. Capitalized terms not explicitly defined herein but defined in the Plan or the Option Agreement will have the same definitions as in the Plan or the Option Agreement. If there is any conflict between the terms herein and the Plan, the terms of the Plan will control.
Optionholder: |
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Date of Grant: |
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Vesting Commencement Date: |
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Number of Shares Subject to Option: |
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Exercise Price (Per Share): |
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Total Exercise Price: |
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Expiration Date: |
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Typeof Grant: |
¨ Incentive Stock Option1 | ¨ Nonstatutory Stock Option | ||||
ExerciseSchedule: |
Same as Vesting Schedule | |||||
VestingSchedule: |
[The shares vest in a series of forty-eight (48) successive equal monthly installments measured from the Vesting Commencement Date, subject to Optionholders Continuous Service as of each such date.] OR [Insert alternative vesting schedule and criteria, as applicable.] | |||||
Payment: |
By one or a combination of the following items (described in the Option Agreement): | |||||
x By cash, check, bank draft or money order payable to the Company | ||||||
x Pursuant to a Regulation T Program if the shares are publicly traded | ||||||
x By delivery of already-owned shares if the shares are publicly traded | ||||||
x If and only to the extent this option is a Nonstatutory Stock Option, and subject to the Companys consent at the time of exercise, by a net exercise arrangement |
1 | If this is an Incentive Stock Option, it (plus other outstanding Incentive Stock Options) cannot be first exercisable for more than $100,000 in value (measured by exercise price) in any calendar year. Any excess over $100,000 is a Nonstatutory Stock Option. |
1.
Additional Terms/Acknowledgements: Optionholder acknowledges receipt of, and understands and agrees to, this Grant Notice, the Option Agreement and the Plan. Optionholder acknowledges and agrees that this Grant Notice and the Option Agreement may not be modified, amended or revised except as provided in the Plan. By accepting this option, Optionholder consents to receive such documents by electronic delivery and to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company. Optionholder further acknowledges that as of the Date of Grant, this Grant Notice, the Option Agreement, and the Plan set forth the entire understanding between Optionholder and the Company regarding the acquisition of stock in the Company and supersede all prior oral and written agreements, promises and/or representations on that subject with the exception of (i) options or other compensatory stock awards previously granted and delivered to Optionholder, and (ii) the following agreements only.
OTHER AGREEMENTS: |
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MEDICINOVA, INC. | OPTIONHOLDER: | |||||||||
By: |
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Signature | Signature | |||||||||
Title: |
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Date: |
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Date: |
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ATTACHMENTS: Option Agreement, 2013 Equity Incentive Plan and Notice of Exercise
2.
MEDICINOVA, INC.
2013 EQUITY INCENTIVE PLAN
OPTION AGREEMENT
(INCENTIVE STOCK OPTION OR NONSTATUTORY STOCK OPTION)
Pursuant to your Stock Option Grant Notice (Grant Notice) and this Option Agreement (this Option Agreement), MediciNova, Inc. (the Company) has granted you an option under its 2013 Equity Incentive Plan (the Plan) to purchase the number of shares of the Companys Common Stock indicated in your Grant Notice at the exercise price indicated in your Grant Notice. The option is granted to you effective as of the date of grant set forth in the Grant Notice (the Date of Grant). If there is any conflict between the terms in this Option Agreement and the Plan, the terms of the Plan will control. Capitalized terms not explicitly defined in this Option Agreement or in the Grant Notice but defined in the Plan will have the same definitions as in the Plan.
The details of your option, in addition to those set forth in the Grant Notice and the Plan, are as follows:
1. VESTING. Your option will vest as provided in your Grant Notice. Vesting will cease upon the termination of your Continuous Service.
2. NUMBER OF SHARES AND EXERCISE PRICE. The number of shares of Common Stock subject to your option and your exercise price per share in your Grant Notice will be adjusted for Capitalization Adjustments.
3. EXERCISE RESTRICTION FOR NON-EXEMPT EMPLOYEES. If you are an Employee eligible for overtime compensation under the Fair Labor Standards Act of 1938, as amended (that is, a Non-Exempt Employee), and except as otherwise provided in the Plan, you may not exercise your option until you have completed at least six (6) months of Continuous Service measured from the Date of Grant.
4. METHOD OF PAYMENT. You must pay the full amount of the exercise price for the shares you wish to exercise. You may pay the exercise price in cash or by check, bank draft or money order payable to the Company or in any other manner permitted by your Grant Notice, which may include one or more of the following:
(a) Provided that at the time of exercise the Common Stock is publicly traded, pursuant to a program developed under Regulation T as promulgated by the Federal Reserve Board that, prior to the issuance of Common Stock, results in either the receipt of cash (or check) by the Company or the receipt of irrevocable instructions to pay the aggregate exercise price to the Company from the sales proceeds. This manner of payment is also known as a broker-assisted exercise, same day sale, or sell to cover.
(b) Provided that at the time of exercise the Common Stock is publicly traded, by delivery to the Company (either by actual delivery or attestation) of already-owned shares of Common Stock that are owned free and clear of any liens, claims, encumbrances or security interests, and that are valued at Fair Market Value on the date of exercise. Delivery for these purposes, in the sole discretion of the Company at the time you exercise your option, will include delivery to the Company of your attestation of ownership of such shares of Common Stock in a form approved by the Company. You may not exercise your option by delivery to the Company of Common Stock if doing so would violate the provisions of any law, regulation or agreement restricting the redemption of the Companys stock.
(c) If this option is a Nonstatutory Stock Option, subject to the consent of the Company at the time of exercise, by a net exercise arrangement pursuant to which the Company will reduce the number of shares of Common Stock issued upon exercise of your option by the largest whole number of shares with a Fair Market Value that does not exceed the aggregate exercise price. You must pay any remaining balance of the aggregate exercise price not satisfied by the net exercise in cash or other permitted form of payment. Shares of Common Stock will no longer be outstanding under your option and will not be exercisable thereafter if those shares (i) are used to pay the exercise price pursuant to the net exercise, (ii) are delivered to you as a result of such exercise, and (iii) are withheld to satisfy your tax withholding obligations.
3.
5. WHOLE SHARES. You may exercise your option only for whole shares of Common Stock.
6. SECURITIES LAW COMPLIANCE. In no event may you exercise your option unless the shares of Common Stock issuable upon such exercise are then registered under the Securities Act or, if not registered, the Company has determined that such exercise and the issuance of the shares would be exempt from the registration requirements of the Securities Act. The exercise of your option also must comply with all other applicable laws and regulations governing your option, and you may not exercise your option if the Company determines that such exercise would not be in material compliance with such laws and regulations (including any restrictions on exercise required for compliance with Treas. Reg. 1.401(k)-1(d)(3), if applicable).
7. TERM. You may not exercise your option before the Date of Grant or after the expiration of the options term. The term of your option expires, subject to the provisions of Section 5(h) of the Plan, upon the earliest of the following:
(a) immediately upon the termination of your Continuous Service for Cause;
(b) three (3) months after the termination of your Continuous Service for any reason other than Cause, your Disability or your death (except as otherwise provided in Section 7(d) below); provided, however, that if during any part of such three (3) month period your option is not exercisable solely because of the condition set forth in the section above relating to Securities Law Compliance, your option will not expire until the earlier of the Expiration Date or until it has been exercisable for an aggregate period of three (3) months after the termination of your Continuous Service; provided further, if during any part of such three (3) month period, the sale of any Common Stock received upon exercise of your option would violate the Companys insider trading policy, then your option will not expire until the earlier of the Expiration Date or until it has been exercisable for an aggregate period of three (3) months after the termination of your Continuous Service during which the sale of the Common Stock received upon exercise of your option would not be in violation of the Companys insider trading policy. Notwithstanding the foregoing, if (i) you are a Non-Exempt Employee, (ii) your Continuous Service terminates within six (6) months after the Date of Grant, and (iii) you have vested in a portion of your option at the time of your termination of Continuous Service, your option will not expire until the earlier of (x) the later of (A) the date that is seven (7) months after the Date of Grant, and (B) the date that is three (3) months after the termination of your Continuous Service, and (y) the Expiration Date;
(c) twelve (12) months after the termination of your Continuous Service due to your Disability (except as otherwise provided in Section 7(d)) below;
(d) eighteen (18) months after your death if you die either during your Continuous Service or within three (3) months after your Continuous Service terminates for any reason other than Cause;
(e) the Expiration Date indicated in your Grant Notice; or
(f) the day before the tenth (10th) anniversary of the Date of Grant.
If your option is an Incentive Stock Option, note that to obtain the federal income tax advantages associated with an Incentive Stock Option, the Code requires that at all times beginning on the Date of Grant and ending on the day three (3) months before the date of your options exercise, you must be an employee of the Company or an Affiliate, except in the event of your death or Disability. The Company has provided for extended exercisability of your option under certain circumstances for your benefit but cannot guarantee that your option will necessarily be treated as an Incentive Stock Option if you continue to provide services to the Company or an Affiliate as a Consultant or Director after your employment terminates or if you otherwise exercise your option more than three (3) months after the date your employment with the Company or an Affiliate terminates.
8. EXERCISE.
(a) You may exercise the vested portion of your option (and the unvested portion of your option if your Grant Notice so permits) during its term by (i) delivering a Notice of Exercise (in a form designated by the Company) or completing such other documents and/or procedures designated by the Company for exercise
4.
and (ii) paying the exercise price and any applicable withholding taxes to the Companys Secretary, stock plan administrator, or such other person as the Company may designate, together with such additional documents as the Company may then require.
(b) By exercising your option you agree that, as a condition to any exercise of your option, the Company may require you to enter into an arrangement providing for the payment by you to the Company of any tax withholding obligation of the Company arising by reason of (i) the exercise of your option, (ii) the lapse of any substantial risk of forfeiture to which the shares of Common Stock are subject at the time of exercise, or (iii) the disposition of shares of Common Stock acquired upon such exercise.
(c) If your option is an Incentive Stock Option, by exercising your option you agree that you will notify the Company in writing within fifteen (15) days after the date of any disposition of any of the shares of the Common Stock issued upon exercise of your option that occurs within two (2) years after the Date of Grant or within one (1) year after such shares of Common Stock are transferred upon exercise of your option.
9. TRANSFERABILITY. Except as otherwise provided in this Section 9, your option is not transferable, except by will or by the laws of descent and distribution, and is exercisable during your life only by you.
(a) Certain Trusts. Upon receiving written permission from the Board or its duly authorized designee, you may transfer your option to a trust if you are considered to be the sole beneficial owner (determined under Section 671 of the Code and applicable state law) while the option is held in the trust. You and the trustee must enter into transfer and other agreements required by the Company.
(b) Domestic Relations Orders. Upon receiving written permission from the Board or its duly authorized designee, and provided that you and the designated transferee enter into transfer and other agreements required by the Company, you may transfer your option pursuant to the terms of a domestic relations order, official marital settlement agreement or other divorce or separation instrument as permitted by Treasury Regulation 1.421-1(b)(2) that contains the information required by the Company to effectuate the transfer. You are encouraged to discuss the proposed terms of any division of this option with the Company prior to finalizing the domestic relations order or marital settlement agreement to help ensure the required information is contained within the domestic relations order or marital settlement agreement. If this option is an Incentive Stock Option, this option may be deemed to be a Nonstatutory Stock Option as a result of such transfer.
(c) Beneficiary Designation. Upon receiving written permission from the Board or its duly authorized designee, you may, by delivering written notice to the Company, in a form approved by the Company and any broker designated by the Company to handle option exercises, designate a third party who, on your death, will thereafter be entitled to exercise this option and receive the Common Stock or other consideration resulting from such exercise. In the absence of such a designation, your executor or administrator of your estate will be entitled to exercise this option and receive, on behalf of your estate, the Common Stock or other consideration resulting from such exercise.
10. OPTION NOT A SERVICE CONTRACT. Your option is not an employment or service contract, and nothing in your option will be deemed to create in any way whatsoever any obligation on your part to continue in the employ of the Company or an Affiliate, or of the Company or an Affiliate to continue your employment. In addition, nothing in your option will obligate the Company or an Affiliate, their respective stockholders, boards of directors, officers or employees to continue any relationship that you might have as a Director or Consultant for the Company or an Affiliate.
11. WITHHOLDING OBLIGATIONS.
(a) At the time you exercise your option, in whole or in part, and at any time thereafter as requested by the Company, you hereby authorize withholding from payroll and any other amounts payable to you, and otherwise agree to make adequate provision for (including by means of a same day sale pursuant to a program developed under Regulation T as promulgated by the Federal Reserve Board to the extent
5.
permitted by the Company), any sums required to satisfy the federal, state, local and foreign tax withholding obligations of the Company or an Affiliate, if any, which arise in connection with the exercise of your option.
(b) If this option is a Nonstatutory Stock Option, then upon your request and subject to approval by the Company, and compliance with any applicable legal conditions or restrictions, the Company may withhold from fully vested shares of Common Stock otherwise issuable to you upon the exercise of your option a number of whole shares of Common Stock having a Fair Market Value, determined by the Company as of the date of exercise, not in excess of the minimum amount of tax required to be withheld by law (or such lower amount as may be necessary to avoid classification of your option as a liability for financial accounting purposes). Any adverse consequences to you arising in connection with such share withholding procedure shall be your sole responsibility.
(c) You may not exercise your option unless the tax withholding obligations of the Company and/or any Affiliate are satisfied. Accordingly, you may not be able to exercise your option when desired even though your option is vested, and the Company will have no obligation to issue a certificate for such shares of Common Stock or release such shares of Common Stock from any escrow provided for herein, if applicable, unless such obligations are satisfied.
12. TAX CONSEQUENCES. You hereby agree that the Company does not have a duty to design or administer the Plan or its other compensation programs in a manner that minimizes your tax liabilities. You will not make any claim against the Company, or any of its Officers, Directors, Employees or Affiliates related to tax liabilities arising from your option or your other compensation. In particular, you acknowledge that this option is exempt from Section 409A of the Code only if the exercise price per share specified in the Grant Notice is at least equal to the fair market value per share of the Common Stock on the Date of Grant and there is no other impermissible deferral of compensation associated with the option.
13. NOTICES. Any notices provided for in your option or the Plan will be given in writing (including electronically) and will be deemed effectively given upon receipt or, in the case of notices delivered by mail by the Company to you, five (5) days after deposit in the United States mail, postage prepaid, addressed to you at the last address you provided to the Company. The Company may, in its sole discretion, decide to deliver any documents related to participation in the Plan and this option by electronic means or to request your consent to participate in the Plan by electronic means. By accepting this option, you consent to receive such documents by electronic delivery and to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.
14. GOVERNING PLAN DOCUMENT. Your option is subject to all the provisions of the Plan, the provisions of which are hereby made a part of your option, and is further subject to all interpretations, amendments, rules and regulations, which may from time to time be promulgated and adopted pursuant to the Plan. If there is any conflict between the provisions of your option and those of the Plan, the provisions of the Plan will control. In addition, your option (and any compensation paid or shares issued under your option) is subject to recoupment in accordance with The DoddFrank Wall Street Reform and Consumer Protection Act and any implementing regulations thereunder, any clawback policy adopted by the Company and any compensation recovery policy otherwise required by applicable law.
15. OTHER DOCUMENTS. You hereby acknowledge receipt of and the right to receive a document providing the information required by Rule 428(b)(1) promulgated under the Securities Act, which includes the Plan prospectus. In addition, you acknowledge receipt of the Companys policy permitting certain individuals to sell shares only during certain window periods and the Companys insider trading policy, in effect from time to time.
16. EFFECT ON OTHER EMPLOYEE BENEFIT PLANS. The value of this option will not be included as compensation, earnings, salaries, or other similar terms used when calculating your benefits under any employee benefit plan sponsored by the Company or any Affiliate, except as such plan otherwise expressly provides. The
6.
Company expressly reserves its rights to amend, modify, or terminate any of the Companys or any Affiliates employee benefit plans.
17. VOTING RIGHTS. You will not have voting or any other rights as a stockholder of the Company with respect to the shares to be issued pursuant to this option until such shares are issued to you. Upon such issuance, you will obtain full voting and other rights as a stockholder of the Company. Nothing contained in this option, and no action taken pursuant to its provisions, will create or be construed to create a trust of any kind or a fiduciary relationship between you and the Company or any other person.
18. SEVERABILITY. If all or any part of this Option Agreement or the Plan is declared by any court or governmental authority to be unlawful or invalid, such unlawfulness or invalidity will not invalidate any portion of this Option Agreement or the Plan not declared to be unlawful or invalid. Any Section of this Option Agreement (or part of such a Section) so declared to be unlawful or invalid shall, if possible, be construed in a manner which will give effect to the terms of such Section or part of a Section to the fullest extent possible while remaining lawful and valid.
19. MISCELLANEOUS.
(a) The rights and obligations of the Company under your option will be transferable to any one or more persons or entities, and all covenants and agreements hereunder will inure to the benefit of, and be enforceable by the Companys successors and assigns.
(b) You agree upon request to execute any further documents or instruments necessary or desirable in the sole determination of the Company to carry out the purposes or intent of your option.
(c) You acknowledge and agree that you have reviewed your option in its entirety, have had an opportunity to obtain the advice of counsel prior to executing and accepting your option, and fully understand all provisions of your option.
(d) This Option Agreement will be subject to all applicable laws, rules, and regulations, and to such approvals by any governmental agencies or national securities exchanges as may be required.
(e) All obligations of the Company under the Plan and this Option Agreement will be binding on any successor to the Company, whether the existence of such successor is the result of a direct or indirect purchase, merger, consolidation, or otherwise, of all or substantially all of the business and/or assets of the Company.
* * *
This Option Agreement will be deemed to be signed by you upon the signing by
you of the Stock Option Grant Notice to which it is attached.
7.
NOTICE OF EXERCISE
MEDICINOVA, INC. 4275 EXECUTIVE SQUARE, SUITE 650 LA JOLLA, CA 92037 |
Date of Exercise: |
This constitutes notice to MediciNova, Inc. (the Company) under my stock option that I elect to purchase the below number of shares of Common Stock of the Company (the Shares) for the price set forth below.
Type of option (check one): |
Incentive ¨ | Nonstatutory ¨ | ||
Stock option dated: |
||||
Number of Shares as to which option is exercised: |
||||
Certificates to be issued in name of: |
||||
Total exercise price: |
$ | $ | ||
Cash payment delivered herewith: |
$ | $ | ||
Value of Shares delivered herewith1: |
$ | $ | ||
Value of Shares pursuant to net exercise2: |
$ | $ | ||
Regulation T Program (cashless exercise3): |
$ | $ |
By this exercise, I agree (i) to provide such additional documents as you may require pursuant to the terms of the MediciNova, Inc. 2013 Equity Incentive Plan, (ii) to provide for the payment by me to you (in the manner designated by you) of your withholding obligation, if any, relating to the exercise of this option, and (iii) if this exercise relates to an incentive stock option, to notify you in writing within fifteen (15) days after the date of any disposition of any of the Shares issued upon exercise of this option that occurs within two (2) years after the date of grant of this option or within one (1) year after such Shares are issued upon exercise of this option.
Very truly yours, |
Signature of Optionholder |
Print Name of Optionholder |
1 | Shares must meet the public trading requirements set forth in the option agreement. Shares must be valued in accordance with the terms of the option being exercised, and must be owned free and clear of any liens, claims, encumbrances or security interests. Certificates must be endorsed or accompanied by an executed assignment separate from certificate. |
2 | The option must be a Nonstatutory Stock Option, and MediciNova, Inc. must have established net exercise procedures at the time of exercise, in order to utilize this payment method. |
3 | Shares must meet the public trading requirements set forth in the option agreement. |
8.
EXHIBIT 31.1
MEDICINOVA, INC.
Certification of the Chief Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 for the Period Ended September 30, 2013
I, Yuichi Iwaki, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q for the period ended September 30, 2013 of MediciNova, Inc. (the Registrant);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
4. The Registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the Registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the Registrants internal control over financial reporting that occurred during the Registrants most recent fiscal quarter (the Registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrants internal control over financial reporting; and
5. The Registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrants auditors and the audit committee of the Registrants board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrants ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrants internal control over financial reporting.
Date: November 7, 2013 | ||
By: | /S/ YUICHI IWAKI | |
Yuichi Iwaki, M.D., Ph.D. President and Chief Executive Officer (Principal Executive Officer) |
EXHIBIT 31.2
MEDICINOVA, INC.
Certification of the Chief Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 for the Period Ended September 30, 2013
I, Michael Gennaro, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q for the period ended September 30, 2013 of MediciNova, Inc. (the Registrant);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
4. The Registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the Registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the Registrants internal control over financial reporting that occurred during the Registrants most recent fiscal quarter (the Registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrants internal control over financial reporting; and
5. The Registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrants auditors and the audit committee of the Registrants board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrants ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrants internal control over financial reporting.
Date: November 7, 2013 | ||
By: | /S/ MICHAEL GENNARO | |
Michael Gennaro Chief Financial Officer (Principal Financial Officer) |
EXHIBIT 32.1
CERTIFICATION OF
CHIEF EXECUTIVE OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350
(SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002)
In connection with the accompanying Quarterly Report on Form 10-Q of MediciNova, Inc. (the Company) for the period ended September 30, 2013, as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Yuichi Iwaki, as President and Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: November 7, 2013 | ||
By: | /S/ YUICHI IWAKI | |
Yuichi Iwaki, M.D., Ph.D. President and Chief Executive Officer (Principal Executive Officer) |
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and such certification is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
EXHIBIT 32.2
CERTIFICATION OF
CHIEF FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350
(SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002)
In connection with the accompanying Quarterly Report on Form 10-Q of MediciNova, Inc. (the Company) for the period ended September 30, 2013, as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Michael Gennaro, as Chief Financial Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: November 7, 2013 | ||
By: | /S/ MICHAEL GENNARO | |
Michael Gennaro Chief Financial Officer (Principal Financial Officer) |
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and such certification is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.