SAN DIEGO, May 10, 2012 (GLOBE NEWSWIRE) -- MediciNova, Inc. a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), announced financial results for the first quarter ended March 31, 2012.
A detailed discussion of financial results and product development programs can be found in MediciNova's Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, which was filed with the Securities and Exchange Commission on May 10, 2012 and is available through investors.medicinova.com/sec.cfm.
Financial Results
For the quarter ended March 31, 2012, MediciNova reported a net loss of $3.9 million, or $0.24 per share, compared to a net loss of $5.7 million, or $0.45 per share, for the same period last year. In the three months ended March 31, 2012, recorded sponsored research and development revenue relating to the Kissei services agreement $0.2 million. There was no revenue for the three months ended March 31, 2011. Research and development expenses were $1.9 million for the quarter ended March 31, 2012, compared to $2.6 million for the quarter ended March 31, 2011. The decrease of $0.7 million was due to less product development spending on MN-221 for acute exacerbations of asthma and chronic obstructive pulmonary disease (COPD). General and administrative expenses were $2.2 million for the quarter ended March 31, 2012, compared to $2.4 million for the quarter ended March 31, 2011. The decrease of $0.2 million was due to decreases in salary and bonus expense, partially offset by an increase in stock-based compensation expense.
At March 31, 2012, we had $11.0 million in cash and cash equivalents, as compared to $31.4 million of cash and cash equivalents at March 31, 2011.
Highlights in 2012
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On April 23, 2012 MediciNova announced that it had received a Notice of Allowance from the Australian Government Patent Office for a pending patent application that covers the use of ibudilast (MN-166) for the treatment of multiple forms of chronic neuropathic pain.
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On March 21, 2012 MediciNova announced that it had completed enrollment in its Phase 2 clinical trial (MN-221-CL-007) evaluating the efficacy and safety of MN-221 for treatment of acute exacerbations of asthma for patients who do not respond to standard pharmacotherapy.
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On March 13, 2012 MediciNova announced that it had received a Notice of Allowance from the Japanese Patent Office for a pending patent application that covers the use of ibudilast (MN-166) for the treatment of multiple forms of chronic neuropathic pain.
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On February 1, 2012 MediciNova announced that it had received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application that covers the use of ibudilast (MN-166) for the treatment of progressive forms of multiple sclerosis.
- On January 16, 2012 MediciNova and the University of Colorado (CU) Boulder disclosed a license agreement for the use of ibudilast (MN-166) for the treatment of post-traumatic brain injury (TBI).
"2012 is off to a great start as we completed patient enrollment in our Phase 2 clinical trial for MN-221," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "We plan to announce our data analysis from that trial in the second quarter of 2012. Kissei Pharmaceutical Co., Ltd. has been very supportive of our progress and development of MN-221. Their investment and additional funding have been a great benefit to MediciNova as we look to continue development for MN-221. In addition, we are encouraged by the progress on our ibudilast (MN-166) asset with the expanded patent portfolio and investigator-led clinical trials ongoing."
MediciNova will hold a conference call with management to discuss 1Q earnings and the results of the MN-221-CL-007 Phase 2 trial upon completion of the ongoing data analysis.
About MediciNova
MediciNova, Inc. is a publicly traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need with a commercial focus on the U.S. market. Through strategic alliances primarily with Japanese pharmaceutical companies, MediciNova holds rights to a diversified portfolio of clinical and preclinical product candidates, each of which MediciNova believes has a well-characterized and differentiated therapeutic profile, attractive commercial potential, and patent coverage of commercially adequate scope. MediciNova's pipeline includes six clinical-stage compounds for the treatment of acute exacerbations of asthma, chronic obstructive pulmonary disease exacerbations, multiple sclerosis and other neurologic conditions, asthma, interstitial cystitis, solid tumor cancers, generalized anxiety disorder, preterm labor and urinary incontinence and two preclinical-stage compounds for the treatment of thrombotic disorders. MediciNova's current strategy is to focus on its two prioritized product candidates, MN-221, for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease exacerbations, and ibudilast (MN-166). MN-221 is involved in clinical trials under U.S. INDs. MN-166 is involved in clinical trials under Investigator INDs. MediciNova is engaged in strategic partnering discussions to support further development of the MN-221 and ibudilast programs. Additionally, MediciNova will seek to monetize opportunistically its other pipeline candidates. For more information on MediciNova, Inc., please visit www.medicinova.com.
The MediciNova, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3135
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding our progress and expectations on future progress in the development of our drug candidates, expected timing of clinical trial results and any implication as to the results of our development, partnering and funding efforts or that the company will have the ability to execute on its priorities. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements, include, but are not limited to, risks and uncertainties inherent in clinical trials including the unknown outcome of the Phase 2 trial of MN-221 for the treatment of acute exacerbations of asthma, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials and the timing, cost and design of future clinical trials and research activities, the timing of expected filings with the regulatory authorities, risks relating to the completion of the joint venture in China, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2011 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.
| MEDICINOVA, INC. | ||
| CONSOLIDATED BALANCE SHEETS | ||
|
March 31, 2012 |
December 31, 2011 |
|
| (Unaudited) | ||
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $ 11,005,842 | $ 15,093,124 |
| Prepaid expenses and other current assets | 798,383 | 614,540 |
| Total current assets | 11,804,225 | 15,707,664 |
| Goodwill | 9,600,241 | 9,600,241 |
| In-process research and development | 4,800,000 | 4,800,000 |
| Investment in China Joint Venture | 680,000 | 650,000 |
| Property and equipment, net | 28,505 | 29,425 |
| Total assets | $ 26,912,971 | $ 30,787,330 |
| Liabilities and Stockholders' Equity | ||
| Current liabilities: | ||
| Accounts payable | $ 309,417 | $ 718,882 |
| Accrued expenses | 1,192,635 | 1,509,325 |
| Income taxes payable | 1,084 | 6,490 |
| Accrued compensation and related expenses | 566,294 | 599,087 |
| Current deferred revenue | 672,336 | 863,510 |
| Total current liabilities | 2,741,766 | 3,697,294 |
| Deferred tax liability | 1,956,000 | 1,956,000 |
| Long-term deferred revenue | 1,636,490 | 1,636,490 |
| Total liabilities | 6,334,256 | 7,289,784 |
| Stockholders' equity: | ||
| Preferred stock, $0.01 par value; 500,000 shares authorized at March 31, 2012 and December 31, 2011; 220,000 shares issued at March 31, 2012 and December 31, 2011 | 2,200 | 2,200 |
| Common stock, $0.001 par value; 30,000,000 shares authorized at March 31, 2012 and December 31, 2011; 16,127,615 shares issued at March 31, 2012 and December 31, 2011, respectively, and 16,103,565 and 16,088,015 shares outstanding at March 31, 2012 and December 31, 2011, respectively | 16,128 | 16,128 |
| Additional paid-in capital | 310,925,542 | 309,998,251 |
| Accumulated other comprehensive loss | (63,633) | (56,845) |
| Treasury stock, at cost; 24,050 shares at March 31, 2012 and 39,600 shares at December 31, 2011 | (1,161,816) | (1,189,705) |
| Deficit accumulated during the development stage | (289,139,706) | (285,272,483) |
| Total stockholders' equity | 20,578,715 | 23,497,546 |
| Total liabilities and stockholders' equity | $ 26,912,971 | $ 30,787,330 |
| MEDICINOVA, INC. | ||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
| (Unaudited) | ||||
|
Three months ended March 31, |
Period from September 26, |
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|
2012 |
2011 |
2000 (inception) to March 31, 2012 |
||
| Revenues | $ 191,174 | $ — | $ 1,749,401 | |
| Operating expenses: | ||||
| Cost of revenues | — | — | 1,258,421 | |
| Research and development | 1,878,461 | 2,623,898 | 163,920,024 | |
| General and administrative | 2,185,972 | 2,352,476 | 107,708,496 | |
| Total operating expenses | 4,064,433 | 4,976,374 | 272,886,941 | |
| Operating loss | (3,873,259) | (4,976,374) | (271,137,540) | |
| Impairment charge on investment securities | — | — | (1,735,212) | |
| Other expense | (4,966) | (52,375) | (364,591) | |
| Interest expense | — | (652,387) | (3,605,818) | |
| Other income | 11,002 | 25,406 | 19,131,394 | |
| Loss before income taxes | (3,867,223) | (5,655,730) | (257,711,767) | |
| Income taxes | — | — | (64,817) | |
| Net loss | (3,867,223) | (5,655,730) | (257,776,584) | |
| 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) | |
| Net loss applicable to common stockholders | $ (3,867,223) | $ (5,655,730) | $ (289,139,706) | |
| Basic and diluted net loss per common share | $ (0.24) | $ (0.45) | ||
| Shares used to compute basic and diluted net loss per common share | 16,088,015 | 12,547,759 | ||
| Net loss applicable to common stockholders | $ (3,867,223) | $ (5,655,730) | $ (289,139,706) | |
| Other comprehensive loss, net of tax: | ||||
| Foreign currency translation adjustments | (6,788) | (7,657) | (63,633) | |
| Comprehensive loss | $ (3,874,011) | $ (5,663,387) | $ (289,203,339) | |