SAN DIEGO, Aug. 9, 2012 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), yesterday reported financial results for the second quarter ended June 30, 2012 through the filing of its quarterly report on Form 10-Q.
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 June 30, 2012, which was filed August 9, 2012 and is available through investors.medicinova.com.
Financial Results
For the quarter ended June 30, 2012, MediciNova reported a net loss of $2.3 million, or $0.14 per share, compared to a net loss of $4.7 million, or $0.31 per share, for the same period last year. In the three months ended June 30, 2012, research and development service revenue relating to the Kissei services agreement was $0.5 million. There was no revenue for the three months ended June 30, 2011. Research and development expenses were $1.5 million for the quarter ended June 30, 2012, compared to $2.0 million for the quarter ended June 30, 2011. The decrease in research and development expenses was mainly due to a decrease in spending on our prioritized asset MN-221 for the treatment of acute exacerbations of asthma and COPD due primarily to the completion of the MN-221-CL-007 trial in patients with acute exacerbations of asthma, partially offset by an increase in spending on our MN-221-CL-012 clinical trial, a multiple-dose trial in patients with moderate-to-severe COPD, and also due to lower stock based compensation expense in the most recent quarter. General and administrative expenses were $1.3 million for the quarter ended June 30, 2012, compared to $1.7 million for the quarter ended June 30, 2011. This decrease in general and administrative expenses was due primarily to a decrease in stock-based compensation expense, partially offset by an increase in compensation expense related to employee bonuses.
At June 30, 2012, we had $7.3 million in cash and cash equivalents, as compared to $15.1 million of cash and cash equivalents at December 31, 2011.
Recent Highlights
- On July 2, 2012 MediciNova announced that an End-of-Phase 2 meeting pertaining to the development of MN-221 for the treatment of acute exacerbations of asthma has been scheduled with the United States Food and Drug Administration (FDA). The Division of Pulmonary, Allergy, and Rheumatology Products (DPARP) of the FDA reviewed MediciNova's meeting request submission and granted an End-of-Phase 2 meeting scheduled for October 22, 2012.
- On May 23, 2012 MediciNova announced preliminary trial results for our Phase 2b clinical trial of MN-221 in acute exacerbations of asthma. Given the positive MN-221 efficacy and safety data displayed, our goal is now to advance the development of the MN-221 program.
- On April 23, 2012 MediciNova announced receipt of 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.
- On April 10, 2012 MediciNova announced the addition of David O'Toole, CPA to our Board of Directors. Mr. O'Toole complements the MediciNova Board with over 25 years of experience providing finance, consulting and international tax services to global companies. His international experience includes assignments in Tokyo, Japan and Paris, France. Mr. O'Toole is currently Chief Financial Officer at Response Genetics. Previously, he was Chief Financial Officer at Abraxis Bioscience and Partner at Deloitte & Touche.
"This has been an exciting quarter for MediciNova. The completion and results of the MN-221 Phase 2b clinical trial were very encouraging," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "We believe we have the efficacy data, safety data, and trial design necessary for a productive discussion with the FDA at our End-of-Phase 2 meeting. If all goes well, we anticipate moving our program into pivotal development in the first half of 2013. In addition, we are committed to exploring opportunities to allow for the continued clinical development of ibudilast in a proof-of-concept Phase 2 trial in drug addiction and/or progressive multiple sclerosis."
MediciNova management will plan to host a corporate update conference call later in the quarter. It will focus on the clinical development of MN-221 and MN-166 and strategy moving forward.
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) for neurological disorders. MN-221 is involved in clinical trials under U.S. INDs. MN-166 is being developed in Phase 1b/2 trials for pain and drug addiction, largely through Investigator INDs and outside funding. Proof-of-concept Phase 2b trial(s) in Progressive MS are pending. MediciNova is engaged in strategic partnering and consortium funding discussions to support further development of both the MN-221 and ibudilast/MN-166 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 expectations on the ability to advance MN-221 through a Phase 3 trial, expectations about our end of Phase 2 meeting with the FDA, expectations about the trial design for a Phase 3 trial and our implied expectation that we will be able to obtain additional financing to fund a Phase 3 clinical trial, 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 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 operations 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. | ||
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CONSOLIDATED BALANCE SHEETS |
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| June 30,2012 | December 31,2011 | |
| (Unaudited) | ||
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $ 7,258,530 | $ 15,093,124 |
| Prepaid expenses and other current assets | 634,428 | 614,540 |
| Total current assets | 7,892,958 | 15,707,664 |
| Goodwill | 9,600,241 | 9,600,241 |
| In-process research and development | 4,800,000 | 4,800,000 |
| Investment in joint venture | 679,399 | 650,000 |
| Property and equipment, net | 62,209 | 29,425 |
| Total assets | $ 23,034,807 | $ 30,787,330 |
| Liabilities and Stockholders' Equity | ||
| Current liabilities: | ||
| Accounts payable | $ 440,107 | $ 718,882 |
| Accrued expenses | 742,950 | 1,515,815 |
| Accrued compensation and related expenses | 209,317 | 599,087 |
| Current deferred revenue | 1,815,203 | 863,510 |
| Total current liabilities | 3,207,577 | 3,697,294 |
| Deferred tax liability | 1,956,000 | 1,956,000 |
| Long-term deferred revenue | — | 1,636,490 |
| Total liabilities | 5,163,577 | 7,289,784 |
| Stockholders' equity: | ||
| Preferred stock, $0.01 par value; 3,000,000 and 500,000 shares authorized at June 30, 2012 and December 31, 2011, respectively; 220,000 shares issued at June 30, 2012 and December 31, 2011 | 2,200 | 2,200 |
| Common stock, $0.001 par value; 100,000,000 and 30,000,000 shares authorized at June 30, 2012 and December 31, 2011, respectively; 16,187,615 and 16,127,615 shares issued at June 30, 2012 and December 31, 2011, respectively, and 16,163,565 and 16,088,015 shares outstanding at June 30, 2012 and December 31, 2011, respectively | 16,188 | 16,128 |
| Additional paid-in capital | 310,497,442 | 309,998,251 |
| Accumulated other comprehensive loss | (61,728) | (56,845 ) |
| Treasury stock, at cost; 24,050 shares at June 30, 2012 and 39,600 shares at December 31, 2011 | (1,161,816 ) | (1,189,705 ) |
| Deficit accumulated during the development stage | (291,421,056) | (285,272,483 ) |
| Total stockholders' equity | 17,871,230 | 23,497,546 |
| Total liabilities and stockholders' equity | $ 23,034,807 | $ 30,787,330 |
| MEDICINOVA, INC. | ||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||
| (Unaudited) | ||||||
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Three months ended June 30, |
Six months ended June 30, |
Period from September 26, 2000 (inception) to June 30, |
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| 2012 | 2011 | 2012 | 2011 | 2012 | ||
| Revenues | $ 493,623 | $ — | $ 684,797 | $ — | $ 2,243,024 | |
| Operating expenses: | ||||||
| Cost of revenues | — | — | — | — | 1,258,421 | |
| Research and development | 1,483,939 | 2,040,060 | 3,362,400 | 4,663,958 | 165,403,963 | |
| General and administrative | 1,297,888 | 1,682,246 | 3,483,860 | 4,034,722 | 109,006,384 | |
| Total operating expenses | 2,781,827 | 3,722,306 | 6,846,260 | 8,698,680 | 275,668,768 | |
| Operating loss | (2,288,204) | (3,722,306) | (6,161,463) | (8,698,680) | (273,425,744) | |
| Impairment charge on investment securities | — | — | — | — | (1,735,212) | |
| Other expense | (81) | (31,494) | (5,047) | (83,869) | (364,672) | |
| Interest expense | — | (943,745) | — | (1,596,132) | (3,605,818) | |
| Other income | 6,935 | 16,197 | 17,937 | 41,603 | 19,138,329 | |
| Loss before income taxes | (2,281,350) | (4,681,348) | (6,148,573) | (10,337,078) | (259,993,117) | |
| Income taxes | — | — | — | — | (64,817) | |
| Net loss | (2,281,350) | (4,681,348) | (6,148,573) | (10,337,078) | (260,057,934) | |
| 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 | $ (2,281,350) | $ (4,681,348) | $ (6,148,573) | $ (10,337,078) | $ (291,421,056) | |
| Basic and diluted net loss per common share | $ (0.14) | $ (0.31) | $ (0.38) | $ (0.74) | ||
| Shares used to compute basic and diluted net loss per common share | 16,143,125 | 15,319,273 | 16,115,570 | 13,941,172 | ||
| Net loss applicable to common stockholders | $ (2,281,350) | $ (4,681,348) | (6,148,573) | $ (10,337,078) | $ (291,421,056) | |
| Other comprehensive loss, net of tax: | ||||||
| Foreign currency translation adjustments | 1,905 | 2,314 | (4,883) | (5,343) | (61,728) | |
| Comprehensive loss | $ (2,279,445) | $ (4,679,034) | $ (6,153,456) | $ (10,342,421) | $ (291,482,784) | |