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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED
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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:
(Exact name of registrant as specified in its charter)
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(State or Other Jurisdiction of Incorporation or Organization) |
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(I.R.S. Employer Identification No.) |
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(Address of Principal Executive Offices) |
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(Zip Code) |
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(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
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(Title of each class) |
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(Trading symbol(s)) |
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(Name of each exchange on which registered) |
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.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “accelerated filer”, “large accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:
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Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of May 12,
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q, in particular "Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations," and the information incorporated by reference herein contains “forward-looking statements”. The forward-looking statements are contained principally in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” but are also contained elsewhere in this report. Forward-looking statements include all statements that are not historical facts and, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would" or the negative version of these words and similar expressions.
Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including those described in "Risk Factors" and elsewhere in this report. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our beliefs and assumptions only as of the date of this report. Considering the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. You should read this report completely and with the understanding that our actual future results may be materially different from what we expect.
The following factors are among those that may cause actual results to differ materially from our forward-looking statements:
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Inability to raise additional capital if needed; |
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Inability to generate revenues from product sales to continue business operations; |
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Inability to develop and commercialize our product candidates; |
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Failure or delay in completing clinical trials or obtaining Food and Drug Administration or foreign regulatory approval for our product candidates in a timely manner; |
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Unsuccessful clinical trials stemming from clinical trial designs, failure to enroll a sufficient number of patients, undesirable side effects and other safety concerns; |
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Inability to demonstrate sufficient efficacy of product candidates; |
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Reliance on the success of our MN-166 (ibudilast) and MN-001 (tipelukast) product candidates; |
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Delays in commencement or completion of clinical trials or suspension or termination of clinical trials; |
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Loss of our licensed rights to develop and commercialize a product candidate as a result of the termination of the underlying licensing agreement; |
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Competitors may develop products rendering our product candidates obsolete and noncompetitive; |
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The widespread outbreak of an illness or any other communicable disease, such as COVID-19, which has lead to key employees becoming ill for a period of time; |
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Inability to successfully attract partners and enter into collaborations on acceptable terms; |
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Dependence on third parties to conduct clinical trials and to manufacture product candidates; |
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Dependence on third parties to market and distribute products; |
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Our product candidates, if approved, may not gain market acceptance or obtain adequate coverage for third party reimbursement; |
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Disputes or other developments concerning our intellectual property rights; |
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Actual and anticipated fluctuations in our quarterly or annual operating results; |
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Price and volume fluctuations in the overall stock markets; |
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Litigation or public concern about the safety of our potential products; |
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International trade or foreign exchange restrictions, increased tariffs, foreign currency exchange; |
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High quality material for our products may become difficult to obtain or expensive; |
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Strict government regulations on our business; |
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Regulations governing the production or marketing of our product candidates; |
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Loss of, or inability to attract, key personnel; and |
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Economic, political, foreign exchange and other risks associated with international operations. |
2
MEDICINOVA, INC.
TABLE OF CONTENTS
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4 |
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ITEM 1. |
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4 |
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ITEM 2. |
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
15 |
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ITEM 3. |
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ITEM 4. |
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ITEM 1. |
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20 |
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ITEM 1A. |
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20 |
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ITEM 2. |
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ITEM 3. |
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20 |
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ITEM 4. |
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ITEM 5. |
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ITEM 6. |
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21 |
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3
PART I. FINANCIAL INFORMATION
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ITEM 1. |
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS. |
MEDICINOVA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
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March 31, |
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December 31, |
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2022 |
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2021 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Prepaid expenses and other current assets |
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Total current assets |
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Goodwill |
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In-process research and development |
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Property and equipment, net |
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Right-of-use asset |
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Other non-current assets |
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Total assets |
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$ |
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$ |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued liabilities and other current liabilities |
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Operating lease liability |
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Total current liabilities |
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Deferred tax liability |
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Other non-current liabilities |
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Total liabilities |
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Commitments and contingencies (Note 4) |
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Stockholders’ equity: |
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Common stock, $ March 31, 2022 and December 31, 2021; shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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( |
) |
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( |
) |
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Accumulated deficit |
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( |
) |
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( |
) |
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Total stockholders’ equity |
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Total liabilities and stockholders' equity |
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$ |
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$ |
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See accompanying notes.
4
MEDICINOVA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
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Three months ended |
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March 31, |
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|||||
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2022 |
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2021 |
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Revenues |
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$ |
— |
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$ |
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Operating expenses: |
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Research, development and patents |
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General and administrative |
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Total operating expenses |
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Operating loss |
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( |
) |
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( |
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Interest income |
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Other expense |
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( |
) |
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( |
) |
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Net loss applicable to common stockholders |
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$ |
( |
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$ |
( |
) |
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Basic and diluted net loss per common share |
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$ |
( |
) |
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$ |
( |
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Shares used to compute basic and diluted net loss per common share |
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Net loss applicable to common stockholders |
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$ |
( |
) |
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$ |
( |
) |
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Other comprehensive loss, net of tax: |
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Foreign currency translation adjustments |
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( |
) |
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( |
) |
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Comprehensive loss |
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$ |
( |
) |
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$ |
( |
) |
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See accompanying notes.
5
MEDICINOVA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)
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Three Months Ended March 31, 2022 |
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Common stock |
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Additional paid-in |
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Accumulated other comprehensive |
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Accumulated |
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Total stockholders’ |
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Shares |
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Amount |
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capital |
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loss |
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deficit |
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equity |
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Balance at December 31, 2021 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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Share-based compensation |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Foreign currency translation adjustments |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
||||
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Balance at March 31, 2022 |
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( |
) |
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( |
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Three Months Ended March 31, 2021 |
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Common stock |
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Additional paid-in |
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Accumulated other comprehensive |
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Accumulated |
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Total stockholders’ |
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Shares |
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Amount |
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capital |
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loss |
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deficit |
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equity |
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Balance at December 31, 2020 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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Share-based compensation |
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— |
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— |
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— |
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— |
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Issuance of common stock for option exercises |
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— |
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— |
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Issuance of shares under an employee stock purchase plan (ESPP) |
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— |
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— |
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Issuance of common stock in a private placement transaction, net of issuance costs |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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||||
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Foreign currency translation adjustments |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
||||
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Balance at March 31, 2021 |
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( |
) |
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( |
) |
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See accompanying notes.
6
MEDICINOVA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
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Three months ended |
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March 31, |
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2022 |
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2021 |
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||
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Operating activities: |
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Net loss |
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$ |
( |
) |
|
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$ |
( |
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|
Adjustments to reconcile net loss to net cash used in operating activities: |
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Non-cash stock-based compensation |
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Depreciation and amortization |
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Reduction in carrying amount of right-of-use asset |
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Changes in assets and liabilities: |
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Accounts receivable |
|
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— |
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|
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( |
) |
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Prepaid expenses and other assets |
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( |
) |
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( |
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Accounts payable, accrued liabilities and other liabilities |
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( |
) |
|
Operating lease liabilities |
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( |
) |
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( |
) |
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Net cash used in operating activities |
|
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( |
) |
|
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( |
) |
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Financing activities: |
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Proceeds from issuance of common stock and exercise of common stock options |
|
|
— |
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Common stock issuance costs |
|
|
— |
|
|
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( |
) |
|
Proceeds from issuance of equity awards under ESPP |
|
|
— |
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Net cash provided by financing activities |
|
|
— |
|
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|
|
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
( |
) |
|
|
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Net change in cash and cash equivalents |
|
|
( |
) |
|
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Cash and cash equivalents, beginning of period |
|
|
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Cash and cash equivalents, end of period |
|
$ |
|
|
|
|
|
$ |
|
|
See accompanying notes.
7
MEDICINOVA, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Interim Financial Information
Organization and Business
MediciNova, Inc. (the “Company” or “MediciNova”) was incorporated in the state of Delaware in September 2000. The Company’s common stock is listed in both the United States and Japan and trades on the NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange. The Company is a biopharmaceutical company focused on developing novel therapeutics for the treatment of serious diseases with unmet medical needs with a commercial focus on the United States market. The Company’s current strategy is to focus its development activities on MN-166 (ibudilast) for neurological and other disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, substance dependence and addiction (e.g., methamphetamine dependence, opioid dependence, and alcohol dependence), and prevention of acute respiratory distress syndrome, and MN-001 (tipelukast) for fibrotic and other diseases such as nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). The Company’s pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbation of asthma, and MN-029 (denibulin) for solid tumor cancers.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information and with the instructions of the Securities and Exchange Commission (SEC) on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the condensed consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the Company’s financial position and of the results of operations and cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries.
These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC. The results of operations for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The balance sheet at December 31, 2021 has been derived from the audited financial statements at that date but does not include all the information and footnotes required by GAAP for complete financial statements.
Reclassification
Certain reclassifications have been made to the prior year financial statements to conform to the current year presentation. The reduction in carrying amount of right-of-use asset was reclassified from the change in prepaid expenses and other assets, and the change in operating lease liabilities was reclassified from the change in accounts payable, accrued liabilities and other liabilities within operating activities in the statement of cash flows for the three months ended March 31, 2021. There was no change to total net cash used in operating activities. These reclassifications had no effect on previously reported results of operations, cash flows, or retained earnings.
Principles of Consolidation
The consolidated financial statements include the accounts of MediciNova, Inc. and its wholly owned subsidiaries, MediciNova Japan, Inc., MediciNova (Europe) Limited, MediciNova Europe GmbH and Avigen Inc. The financial statements of the Company’s foreign subsidiaries are measured using their local currency as the functional currency. The resulting translation adjustments are recorded as a component of other comprehensive income or loss. Intercompany transaction gains or losses at each period end are included as translation adjustments and recorded within other comprehensive income or loss. All intercompany transactions and balances are eliminated in consolidation.
8
Segment Reporting
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company operates in a single operating segment – the acquisition and development of small molecule therapeutics for the treatment of serious diseases with unmet medical needs.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash and other highly liquid investments including money market accounts, with original maturities of three months or less from the date of purchase.
Research, Development and Patents
Research and development costs are expensed in the period incurred. Research and development costs primarily consist of salaries and related expenses for personnel, facilities and depreciation, research and development supplies, licenses and outside services. Such research and development costs totaled $
Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. The Company includes all external costs related to the filing of patents in Research, Development and Patents expenses. Such patent-related expenses totaled $
Clinical Trial Accruals and Prepaid Expenses
Costs for preclinical studies, clinical studies and manufacturing activities are recognized as research and development expenses based on an evaluation of the progress by Company vendors towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided to the Company by such vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services are performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of studies, or the services completed. The Company’s estimates of accrued expenses as of each balance sheet date are based on the facts and circumstances known at the time. Costs that are paid in advance of performance are deferred as a prepaid expense and amortized over the service period as the services are provided.
Leases
The Company determines if an arrangement is a lease at inception and if so, determines whether the lease qualifies as an operating or finance lease. The Company does not recognize right-of-use assets and lease liabilities for leases with a term of 12 months or less and does not separate non-lease components from lease components. Operating lease right-of-use assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Operating lease expense is recognized on a straight-line basis over the lease term and is included in general and administrative expenses. As most of the Company’s operating leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The incremental borrowing rate is the rate that the Company would expect to pay to borrow on a collateralized and fully amortizing basis over a similar term an amount equal to the lease payments in a similar economic environment.
Impact of COVID-19 on the Company’s Business
The pandemic caused by an outbreak of a new strain of coronavirus (“COVID-19” or “the pandemic”) has resulted, and is likely to continue to result, in significant national and global economic disruption and may adversely affect the Company’s business. Although the pandemic resulted in a decrease in the number of patient visits at certain of the Company’s clinical trial sites, the Company expects this effect to be temporary. The Company has seen an increase in the number of patient visits compared to earlier in the pandemic and the Company continues to enroll patients in clinical trials. Throughout the pandemic, the Company has continued with routine clinical trial activities including executing new clinical trial agreements, negotiating budgets, institutional review board (IRB) approvals, site training, and other activities related to the initiation of new clinical trial sites. In addition, following the outbreak of the pandemic, the Company designed a clinical trial to evaluate MN-166 (ibudilast) for prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19. Based on the Company’s current assessment, the Company does not expect a material negative impact on its clinical development plans, long-term development timeline or liquidity due to the worldwide spread of the COVID-19 virus. However, the Company is actively monitoring this situation and the possible effects on its financial condition, liquidity, operations, suppliers, industry, and workforce.
9
Use of Estimates
The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and the accompanying notes. Actual results could differ from those estimates.
Recently Issued Accounting Pronouncements
In June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments— Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). The ASU introduced a new credit loss methodology, the Current Expected Credit Losses (“CECL”) methodology, which requires earlier recognition of credit losses, while also providing additional transparency about credit risk. The CECL methodology utilizes a lifetime “expected credit loss” measurement objective for the recognition of credit losses for loans, held-to maturity debt securities, trade receivables and other receivables measured at amortized cost at the time the financial asset is originated or acquired. Subsequent to the issuance of ASU 2016-13, the FASB issued several additional ASUs to clarify implementation guidance, provide narrow-scope improvements and provide additional disclosure guidance. In November 2019, the FASB issued an amendment making this ASU effective for fiscal years beginning after December 15, 2022 for smaller reporting companies. The new standard will be effective for the Company on January 1, 2023 or at such earlier time where it is no longer a smaller reporting company. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures.
In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for convertible debt instruments by reducing the number of accounting models and the number of embedded features that could be recognized separately from the host contract. Consequently, more convertible debt instruments will be accounted for as a single liability measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives. ASU 2020-06 also requires use of the if-converted method in the diluted earnings per share calculation for convertible instruments. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years for smaller reporting companies, with early adoption permitted. The new standard will be effective for the Company on January 1, 2024 or at such earlier time where it is no longer a smaller reporting company. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures.
2. Revenue Recognition
Revenue Recognition Policy
Revenues historically have consisted mainly of research and development services performed under a contract with a customer. The Company evaluates the separate performance obligation(s) under each contract, allocates the transaction price to each performance obligation considering the estimated stand-alone selling prices of the services and recognizes revenue upon the satisfaction of such obligations at a point in time or over time dependent on the satisfaction of one of the following criteria: (1) the customer simultaneously receives and consumes the economic benefits provided by the vendor’s performance (2) the vendor creates or enhances an asset controlled by the customer (3) the vendor’s performance does not create an asset for which the vendor has an alternative use, and (4) the vendor has an enforceable right to payment for performance completed to date.
Kissei Pharmaceutical Co., Ltd
In October 2011, the Company entered into a collaboration agreement with Kissei Pharmaceutical Co., Ltd., (“Kissei”), to perform research and development services relating to MN-221 (bedoradrine) in exchange for a non-refundable upfront payment of $
10
Genzyme Corporation
In December 2005, Avigen, Inc. and Genzyme Corporation (“Genzyme”) entered into an Assignment Agreement (the “Genzyme Agreement”) in which Genzyme acquired certain gene therapy intellectual property, programs and other related assets from Avigen, Inc. in exchange for an initial $
The development milestones outlined in the Genzyme Agreement did not meet the definition of a substantive milestone obligation under authoritative guidance on revenue recognition for milestone payments, as Genzyme was responsible for the development of the products and there is no further substantive service effort required by the Company. In March 2021, the Company received notice that a gene therapy product based on AAV (adeno-associated virus) vector technology, which was covered under the Genzyme Agreement, achieved two clinical development milestones, triggering two milestone payments. Accordingly, the Company recognized revenue of $
3. Fair Value Measurements
Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:
|
Level 1: |
Observable inputs such as quoted prices in active markets; |
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|
|
Level 2: |
Inputs are quoted prices for similar items in active markets or quoted prices for identical or similar items in markets that are not active near the measurement date; and |
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|
Level 3: |
Unobservable inputs due to little or no market data, which require the reporting entity to develop its own assumptions. |
Cash equivalents, including money market accounts of $
4. Commitments and Contingencies
Lease Commitments
The Company has operating leases primarily for real estate in the United States and Japan. The United States lease is for the Company’s headquarters in San Diego and has a term of
11
Information related to the Company’s right-of-use assets and related lease liabilities are as follows:
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Three months ended |
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March 31, |
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|||||
|
|
|
2022 |
|
|
2021 |
|
||
|
Cash paid for operating lease liabilities |
|
$ |
|
|
|
$ |
|
|
|
Operating lease costs |
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|
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|
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|
|
|
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|
|
|
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|
|
|
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|
|
|
|
March 31, 2022 |
|
|
March 31, 2021 |
|
||
|
Current operating lease liabilities |
|
$ |
|
|
|
$ |
|
|
|
Non-current operating lease liabilities |
|
|
|
|
|
|
|
|
|
Total operating lease liabilities |
|
$ |
|
|
|
$ |
|
|
|
Weighted-average remaining lease term |
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|
|
|
|
|
|
|
Weighted-average discount rate |
|
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|
% |
|
|
|
% |
|
Maturities of operating lease liabilities as of March 31, 2022 were as follows: |
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|
|
|
|
2022 |
|
|
|
$ |
|
|
|
2023 |
|
|
|
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|
|
|
2024 |
|
|
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|
2025 |
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2026 |
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|
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Thereafter |
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|
Total minimum payments |
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|
|
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|
|
|
Less imputed interest |
|
|
|
|
( |
) |
|
Total lease liabilities |
|
|
|
$ |
|
|
Product Liability
The Company’s business exposes it to liability risks from its potential drug products. A successful product liability claim or series of claims brought against the Company could result in the payment of significant amounts of money and divert management’s attention from running the business. The Company may not be able to maintain insurance on acceptable terms, or the insurance may not provide adequate protection in the case of a product liability claim. To the extent that product liability insurance, if available, does not cover potential claims, the Company would be required to self-insure the risks associated with such claims. The Company believes it carries reasonably adequate insurance for product liability.
License and Research Agreements
The Company has entered into in-licensing agreements with various pharmaceutical companies. Under the terms of these agreements, the Company has received licenses to research, know-how and technology claimed in specified patents or patent applications. Under these license agreements, the Company is generally required to make upfront payments and additional payments upon the achievement of milestones and/or royalties on future sales of products until the later of the expiration of the applicable patent or the applicable last date of market exclusivity after the first commercial sale, on a country-by-country basis.
Legal Proceedings
From time to time, the Company may be subject to legal proceedings and claims in the ordinary course of business. The Company is not aware of any such proceedings or claims that it believes will have, individually or in aggregate, a material adverse effect on its business, financial condition or results of operations.
12
5. Stock-based Compensation
Stock Incentive Plans
In June 2013, the Company adopted the 2013 Equity Incentive Plan, or 2013 Plan, under which the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units and other awards to individuals who are then employees, officers, non-employee directors or consultants of the Company or its subsidiaries. The 2013 Plan is the successor to the Company’s Amended and Restated 2004 Stock Incentive Plan, or 2004 Plan. A total of
Certain of the employee stock options granted contain performance conditions, the vesting of which is based on a determination made by the compensation committee followed by an approval of the board of directors as to the achievement of certain corporate objectives at the end of the performance period. The grant date of such awards is the date on which the board of directors makes its determination. For periods preceding the grant date, the expense related to these awards is measured based on their fair value at each reporting date. The estimated fair value of the performance awards granted and the resulting expense is based upon a certain level of achievement of the corporate objectives and other assumptions in determining fair value. The amount of expense ultimately recognized upon the grant date at completion of the performance period could change from the estimate as a result of various factors, including the level of achievement of the corporate objectives, changes in the assumptions used in the Black-Scholes model in determining fair value or fluctuations in the Company’s stock price during the performance period.
Stock Options
Options granted under the 2013 Plan and the 2004 Plan have terms of
A summary of stock option activity and related information as of March 31, 2022 is as follows:
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Number of Option Shares |
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Weighted Average Exercise Price |
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||
|
Outstanding at December 31, 2021 |
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$ |
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|
|
Granted |
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Exercised |
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— |
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— |
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Cancelled |
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( |
) |
|
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|
|
Outstanding at March 31, 2022 |
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|
|
|
|
$ |
|
|
|
|
Exercisable at March 31, 2022 |
|
|
|
|
|
$ |
|
|
|
Employee Stock Purchase Plan
Under the Company’s 2007 Employee Stock Purchase Plan (ESPP),
Compensation Expense
Stock-based compensation expense for stock option awards and ESPP shares are reflected in total operating expenses for each respective year.
13
The following table summarizes stock-based compensation expense for the three months ended March 31, 2022 and 2021, respectively:
|
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Three months ended |
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|||||
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March 31, |
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|||||
|
|
|
2022 |
|
|
2021 |
|
|
||
|
Research, development and patents |
|
$ |
|
|
|
$ |
|
|
|
|
General and administrative |
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
|
|
|
$ |
|
|
|
The Company uses the Black-Scholes valuation model for determining the estimated fair value for stock-based awards granted to employees and considers management’s current expectations of the achievement of the performance objectives for the year.
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|||||
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March 31, 2022 |
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|
March 31, 2021 |
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||
|
Stock Option assumptions: |
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|
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|
|
|
|
Risk-free interest rate |
|
|
|
|
0.45 - 0.92% |
|
||
|
Expected volatility of common stock |
|
|
|
|
75.46 - 76.11% |
|
||
|
Dividend yield |
|
|
|
|
|
|
||
|
Expected term (in years) |
|
|
|
|
|
4.47 - 5.41 |
|
|
As of March 31, 2022, there was $
The weighted-average fair value of each stock option granted during the three months ended March 31, 2022 and 2021, estimated as of the grant date using the Black-Scholes option valuation model, was $
6. Stockholders’ Equity
At-The-Market Issuance Sales Agreements and Private Placement Transactions
On August 23, 2019, the Company entered into an at the market issuance sales agreement (the “2019 ATM Agreement”) with B. Riley FBR, Inc. (B. Riley FBR) pursuant to which the Company may sell common stock through B. Riley FBR from time to time up to an aggregate offering price of $
On January 29, 2021, the Company sold and issued to an investor
7. Net Loss Per Share
The Company computes basic net loss per share using the weighted average number of common shares outstanding during the period. Diluted net loss per share is based upon the weighted average number of common shares and potentially dilutive securities (common share equivalents) outstanding during the period. Common share equivalents outstanding, determined using the treasury stock method, are comprised of shares that may be issued under the Company’s stock option agreements. Common share equivalents are excluded from the diluted net loss per share calculation if their effect is anti-dilutive.
Potentially dilutive outstanding stock options excluded from diluted net loss per common share due to their anti-dilutive effect totaled
14
|
ITEM 2. |
MANAGEMENT’S 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, 2021 included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 16, 2022. 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
We are a biopharmaceutical company focused on developing novel therapeutics for the treatment of serious diseases with unmet medical needs and a commercial focus on the United States market. Our current strategy is to focus our development activities on MN-166 (ibudilast) for neurological and other disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, substance dependence and addiction (e.g., methamphetamine dependence, opioid dependence, and alcohol dependence), and prevention of acute respiratory distress syndrome, and MN-001 (tipelukast) for fibrotic and other diseases such as nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). Our pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbation of asthma and MN-029 (denibulin) for solid tumor cancers. We were incorporated in Delaware in September 2000.
We have incurred significant net losses since our inception. As of March 31, 2022, from inception, our accumulated deficit was $396.4 million. 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 over the long-term if we expand our research and development programs and acquire or in-license products, technologies or businesses that are complementary to our own.
Our goal is to build a sustainable biopharmaceutical business through the successful development of differentiated products for the treatment of serious diseases with unmet medical needs in high-value therapeutic areas. Key elements of our strategy are as follows:
|
|
• |
Pursue the development of MN-166 (ibudilast) for multiple potential indications with the support of non-dilutive financings. |
We intend to advance our diverse MN-166 (ibudilast) program through a combination of investigator-sponsored clinical trials, trials funded through government grants or other grants, and trials funded by us. We intend to pursue additional strategic alliances to help support further clinical development of MN-166 (ibudilast).
|
|
• |
Pursue the development of MN-001 (tipelukast) for fibrotic and other diseases. |
We intend to advance development of MN-001 (tipelukast) through a variety of means, which may include investigator-sponsored trials with or without grant funding as well as trials funded by us.
|
|
• |
Consider strategic partnerships with one or more leading pharmaceutical companies to complete product development and successfully commercialize our products. |
We develop and maintain relationships with pharmaceutical companies that are therapeutic category leaders. We intend to discuss strategic alliances with leading pharmaceutical companies who seek product candidates, such as MN-166 (ibudilast), MN-001 (tipelukast), MN-221 (bedoradrine), and MN-029 (denibulin), which could support our clinical development and product commercialization.
15
Impact of COVID-19 on Our Business
The pandemic caused by an outbreak of a new strain of coronavirus (“COVID-19” or “the pandemic”) has resulted, and is likely to continue to result, in significant national and global economic disruption and may adversely affect our business. Although the pandemic resulted in a decrease in the number of patient visits at certain of our clinical trial sites, we expect this effect to be temporary. We have seen an increase in the number of patient visits compared to earlier in the pandemic and we continue to enroll patients in our clinical trials. Throughout the pandemic, we have continued with routine clinical trial activities including executing new clinical trial agreements, negotiating budgets, institutional review board (IRB) approvals, site training, and other activities related to the initiation of new clinical trial sites. In addition, following the outbreak of the pandemic, we designed a clinical trial to evaluate MN-166 (ibudilast) for prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19, which was based on positive results of a published study of MN-166 (ibudilast) in an animal model of ARDS. During the pandemic, we have been able to continue with routine regulatory activities. For example, we successfully submitted an Investigational New Drug Application (IND) for MN-166 (ibudilast) for prevention of ARDS which was accepted and is now open with the U.S. Food and Drug Administration (FDA). We were also informed by the FDA that the proposed clinical investigation of MN-166 (ibudilast) for the prevention of ARDS in patients with COVID-19 may proceed. Based on management’s current assessment, we do not expect a material negative impact on our clinical development plans, long-term development timeline or liquidity due to the worldwide spread of the COVID-19 virus. However, we are actively monitoring this situation and the possible effects on our financial condition, liquidity, operations, suppliers, industry, and workforce.
Revenues and Cost of Revenues
In October 2011, we entered into a collaboration agreement with Kissei Pharmaceutical Co., Ltd., or Kissei, to perform research and development services relating to MN-221 (bedoradrine) in exchange for a non-refundable upfront payment of $2.5 million. We assessed the services in accordance with the authoritative guidance and concluded that the two studies to be performed under the agreement represented two separate performance obligations. No services have been provided under the collaboration agreement subsequent to completion of the first study that was completed in 2013. In October 2021, we refunded $1.3 million of the prepayment. As of March 31, 2022, we and Kissei were working to mutually terminate the collaboration agreement and cancel the second study contemplated thereunder and we expect to finalize the termination agreement in 2022.
In December 2005, Avigen, Inc. and Genzyme Corporation entered into an Assignment Agreement (the “Genzyme Agreement”) in which Genzyme acquired certain gene therapy intellectual property, programs and other related assets from Avigen in exchange for an initial $12.0 million payment. Avigen could also receive additional development milestone payments, sublicensing fees and royalty payments based on the successful development of products by Genzyme utilizing technologies previously developed by Avigen. We subsequently acquired Avigen in December 2009 along with Avigen’s rights and obligations under the Genzyme Agreement. If Genzyme fails to diligently pursue the commercialization or marketing of products using the assigned technology, as specified in the Genzyme Agreement, some of the rights assigned could revert back to us at a future date.
The development milestones outlined in the Genzyme Agreement did not meet the definition of a substantive milestone obligation under authoritative guidance on revenue recognition for milestone payments, as Genzyme was responsible for the development of the products and there is no further substantive service effort required by us. In March 2021, we received notice that a gene therapy product based on AAV (adeno-associated virus) vector technology, which was covered under the Genzyme Agreement, achieved two clinical development milestones, triggering two milestone payments. Accordingly, we recognized revenue of $4 million during the three months ended March 31, 2021.
Research, Development and Patents Expenses
Our research, development and patents expenses consist primarily of 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 development 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, development and patents 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, development and patents costs are expensed as incurred and we expect to increase such costs through the remainder of 2022 as our development programs progress.
16
The following table summarizes our research, development and patents 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 included in the “Other R&D expense” category (in thousands):
|
|
|
Three months ended |
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|
|||||
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|
|
March 31, |
|
|
|||||
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
External development expense: |
|
|
|
|
|
|
|
|
|
|
MN-221 |
|
$ |
2 |
|
|
$ |
2 |
|
|
|
MN-166 |
|
|
1,617 |
|
|
|
1,249 |
|
|
|
MN-001 |
|
|
7 |
|
|
|
15 |
|
|
|
MN-029 |
|
|
1 |
|
|
|
— |
|
|
|
Other |
|
|
— |
|
|
|
21 |
|
|
|
Total external development expense |
|
|
1,627 |
|
|
|
1,287 |
|
|
|
R&D personnel expense |
|
|
270 |
|
|
|
658 |
|
|
|
R&D facility and depreciation expense |
|
|
15 |
|
|
|
12 |
|
|
|
Patent expenses |
|
|
87 |
|
|
|
115 |
|
|
|
Other R&D expense |
|
|
113 |
|
|
|
73 |
|
|
|
Total research, development and patent expense |
|
$ |
2,112 |
|
|
$ |
2,145 |
|
|
General and Administrative
Our general and administrative costs primarily consist of salaries, stock-based compensation, 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 and in raising capital to support our product development programs or otherwise in connection with increased business development activities related to partnering, out-licensing or product disposition.
Critical Accounting Policies and Estimates
This discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which we have prepared in accordance with United States generally accepted accounting principles. The preparation of these condensed consolidated financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting periods. We base our estimates on historical experience and on various other factors and assumptions that we believe are reasonable under the circumstances at the time the estimates are made, the results of which form the basis for making judgments about the book values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We periodically evaluate our estimates and judgments in light of changes in circumstances, facts and experience.
Our critical accounting policies are those accounting principles generally accepted in the United States that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. For a description of our critical accounting policies, please see the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Policies” contained in our Annual Report on Form 10-K for the year ended December 31, 2021. There have not been any material changes to the critical accounting policies discussed therein during the three months ended March 31, 2022.
17
Results of Operations
Comparison of the three months ended March 31, 2022 and 2021
Revenues
Revenues were $0.0 million and $4.0 million for the three months ended March 31, 2022 and 2021, respectively. The decrease of $4.0 million was due to the receipt of two milestone payments under the Genzyme Agreement in 2021.
Research, Development and Patents Expenses
Research, development and patents expenses were $2.1 million and $2.1 million for the three months ended March 31, 2022 and 2021, respectively. The expense was relatively the same quarter over quarter. Changes were primarily due to a decrease in performance-based stock option expenses offset by an increase in MN-166 related expenses.
General and Administrative Expenses
General and administrative expenses were $1.3 million and $2.1 million for the three months ended March 31, 2022 and 2021, respectively. The decrease of $0.8 million was primarily due to a decrease in performance-based stock option expense.
Liquidity and Capital Resources
Net cash used in operating activities during the three months ended March 31, 2022 was $3.7 million compared to $3.9 million during the same period in 2021. The $0.2 million change is primarily related to the increased net loss and changes in operating assets and liabilities for those periods.
Net cash provided by financing activities was $0.0 million during the three months ended March 31, 2022 compared to $20.1 million during the same period in 2021. Net cash provided by financing activities during the three months ended March 31, 2021 was primarily due to the sale of 3,656,307 shares of common stock under a Securities Purchase Agreement dated as of January 11, 2021 for net proceeds of $19.9 million.
As of March 31, 2022, we had available cash and cash equivalents of $67.7 million and working capital of $65.9 million. As of the date of this report, we believe we have working capital sufficient to fund operations at least through the end of 2023. However, we cannot provide assurance that these capital resources will be sufficient to conduct all our research and development programs as planned.
Equity Financing
On August 23, 2019, we entered into an at the market issuance sales agreement (the “2019 ATM Agreement”) with B. Riley FBR, Inc. (B. Riley FBR) pursuant to which we may sell common stock through B. Riley FBR from time to time up to an aggregate offering price of $75.0 million. Sales of our common stock through B. Riley FBR, if any, will be made by any method that is deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on NASDAQ, on any other existing trading market for the common stock or through a market maker. B. Riley FBR may also sell the common stock in privately negotiated transactions, subject to our prior approval. We agreed to pay B. Riley FBR an aggregate commission rate of up to 3.5% of the gross proceeds of any common stock sold under this agreement. Proceeds from sales of common stock will depend on the number of shares of common stock sold to B. Riley FBR and the per share purchase price of each transaction.
No shares of common stock were sold under the 2019 ATM Agreement in the three months ended March 31, 2022.
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ITEM 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. |
Not applicable.
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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 SEC’s 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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PART II. OTHER INFORMATION
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ITEM 1. |
LEGAL PROCEEDINGS. |
We are not involved in any material legal proceedings as of March 31, 2022. 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.
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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, 2021, 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. We do not believe that there have been any material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2021.
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ITEM 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS. |
None
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ITEM 3. |
DEFAULTS UPON SENIOR SECURITIES. |
None
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ITEM 4. |
MINE SAFETY DISCLOSURES. |
Not applicable
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ITEM 5. |
OTHER INFORMATION. |
None
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ITEM 6. |
EXHIBITS. |
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Exhibit Number |
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Description |
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3.1 |
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3.2 |
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10.1 |
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31.1(1) |
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31.2(1) |
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32.1(1) |
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32.2(1) |
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101.INS(1) |
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Inline XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document. |
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101.SCH(1) |
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Inline XBRL Taxonomy Extension Schema Document. |
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101.CAL(1) |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
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101.DEF(1) |
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Inline XBRL Taxonomy Extension Definition Linkbase Document. |
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101.LAB(1) |
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Inline XBRL Taxonomy Extension Label Linkbase Document. |
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101.PRE(1) |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
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104(1) |
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Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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(1) |
Filed Herewith |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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MEDICINOVA, INC. |
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Date: May 12, 2022 |
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By: |
/s/ YUICHI IWAKI |
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Yuichi Iwaki, M.D., Ph.D. |
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President and Chief Executive Officer |
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(on behalf of the registrant and |
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as the registrant’s Principal Executive Officer) |
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By: |
/s/ DOUGLAS PAULIN |
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Douglas Paulin |
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Chief Financial Officer |
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(on behalf of the registrant and |
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as the registrant’s Principal Financial Officer) |
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