SAN DIEGO, Nov. 8, 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 third quarter ended September 30, 2012 through the filing of its quarterly report on Form 10-Q.
On October 22, 2012 management met with the FDA to review future development of MN-221. Although discussions haven't been finalized, during the meeting the FDA identified the risk/benefit profile of MN-221 as a focal point for any further development of MN-221 and advised that a reduction in hospitalizations would need to be a pivotal trial primary endpoint. MediciNova is considering the design, costs, and timing of potential future clinical trials of MN-221 and will determine its development strategy following the completion of its review.
"We appreciate the FDA's guidance and look forward to providing an update on our MN-221 development strategy after we complete our review," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova.
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 September 30, 2012, which was filed November 8, 2012 and is available through investors.medicinova.com.
For the quarter ended September 30, 2012, MediciNova reported a net loss of $2.4 million, or $0.14 per share, compared to a net loss of $3.9 million, or $0.25 per share, for the same period last year. In the three months ended September 30, 2012, research and development service revenue relating to the Kissei services agreement was $0.1 million. There was no revenue for the three months ended September 30, 2011. Research and development expenses were $0.9 million for the quarter ended September 30, 2012, compared to $1.7 million for the quarter ended September 30, 2011. The decrease in research and development expenses was mainly due to a decrease in spending on MN-221 due 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. General and administrative expenses were $1.6 million for the quarter ended September 30, 2012, compared to $2.2 million for the quarter ended September 30, 2011. This decrease in general and administrative expenses was due primarily to a decrease in stock-based compensation expense.
At September 30, 2012, we had $5.7 million in cash and cash equivalents. In the quarter ended September 30, 2012, the Company raised $1 million pursuant to the initial purchase on its common stock purchase agreement with Aspire Capital Fund, LLC.
Other Recent Highlights
- On October 25, 2012 MediciNova announced that it has received a Notice of Allowance from the European Patent Office for a pending patent application which covers the use of ibudilast (MN-166) for the treatment of progressive forms of multiple sclerosis (MS).
- On September 4, 2012 the University of California, Los Angeles' (UCLA's) Department of Family Medicine/Center for Behavioral and Addiction Medicine, and MediciNova, Inc. announced approval and funding by the National Institutes on Drug Abuse (NIDA), part of the National Institutes of Health, of a Phase 2 clinical trial studying the use of ibudilast (MN-166) for the treatment of methamphetamine addiction.
Building on an ongoing UCLA MN-166 Phase 1b safety trial, NIDA has now awarded grant funding for a statistically powered Phase 2 outpatient study in methamphetamine addicts.
- On August 23, 2012 MediciNova announced positive preliminary results of a Phase 1b clinical trial involving multiple administrations of intravenous MN-221 over several days in patients with stable, moderate-to-severe chronic obstructive pulmonary disease.
- On August 20, 2012 MediciNova announced that it had entered into a common stock purchase agreement with Aspire Capital Fund, LLC, an Illinois limited liability company. Aspire Capital committed to purchase up to $20 million of MediciNova's common stock over a two-year period following the date of the purchase agreement at prices based on the market price at the time of each sale.
"MediciNova has advanced its clinical pipeline in the past three months," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "Ibudilast has been awarded grants worth several millions of dollars. We are encouraged that ibudilast is advancing into a phase 2 proof-of-concept trial in methamphetamine addiction."
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 clinical development strategies, including future development, statements regarding the progress of clinical trials, statements regarding expectations for the ibudilast/MN-166 program, including development of ibudilast/MN-166 for certain indications 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 potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, 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 associated with the reliance on third parties to sponsor and fund clinical trials, 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 of expected filings with the regulatory authorities, 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.
| CONSOLIDATED BALANCE SHEETS |
| September 30, |
| December 31, |
|Cash and cash equivalents||$ 5,744,523||$ 15,093,124|
|Prepaid expenses and other current assets||600,410||614,540|
|Total current assets||6,344,933||15,707,664|
|In-process research and development||4,800,000||4,800,000|
|Investment in joint venture||666,357||650,000|
|Property and equipment, net||88,104||29,425|
|Total assets||$ 21,499,635||$ 30,787,330|
|Liabilities and Stockholders' Equity|
|Accounts payable||$ 332,998||$ 718,882|
|Accrued compensation and related expenses||203,131||599,087|
|Current deferred revenue||45,253||863,510|
|Total current liabilities||1,156,519||3,697,294|
|Deferred tax liability||1,956,000||1,956,000|
|Long-term deferred revenue||1,686,163||1,636,490|
|Preferred stock, $0.01 par value; 3,000,000 and 500,000 shares authorized at September 30, 2012 and December 31, 2011, respectively; 220,000 shares issued at September 30, 2012 and December 31, 2011||2,200||2,200|
|Common stock, $0.001 par value; 100,000,000 and 30,000,000 shares authorized at September 30, 2012 and December 31, 2011, respectively; 17,157,311 and 16,127,615 shares issued at September 30, 2012 and December 31, 2011, respectively, and 17,153,125and 16,088,015 shares outstanding at September 30, 2012 and December 31, 2011, respectively||17,157||16,128|
|Additional paid-in capital||311,671,370||309,998,251|
|Accumulated other comprehensive loss||(58,864)||(56,845)|
|Treasury stock, at cost; 4,186 shares at September 30, 2012 and 39,600 shares at December 31, 2011||(1,131,086)||(1,189,705)|
|Deficit accumulated during the development stage||(293,799,824)||(285,272,483)|
|Total stockholders' equity||16,700,953||23,497,546|
|Total liabilities and stockholders' equity||$ 21,499,635||$ 30,787,330|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
| Three months ended |
| Nine months ended |
| Period from |
| 2000 (inception) |
to September 30,
|Revenues||$ 83,787||$ —||$ 768,584||$ —||$ 2,326,811|
|Cost of revenues||—||—||1,258,421|
|Research and development||872,555||1,679,896||4,234,956||6,343,854||166,276,518|
|General and administrative||1,573,943||2,227,492||5,057,802||6,262,214||110,580,327|
|Total operating expenses||2,446,498||3,907,388||9,292,758||12,606,068||278,115,266|
|Impairment charge on investment securities||—||—||—||—||(1,735,212)|
|Loss before income taxes||(2,372,950)||(3,893,743)||(8,521,523)||(14,230,821)||(262,366,067)|
|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||$ (2,378,768)||$ (3,893,743)||$ (8,527,341)||$ (14,230,821)||$ (293,799,824)|
|Basic and diluted net loss per common share||$ (0.14)||$ (0.25)||$ (0.52)||$ (0.99)|
|Shares used to compute basic and diluted net loss per common share||16,585,172||15,327,275||16,273,247||14,408,284|
|Net loss applicable to common stockholders||$ (2,378,768)||$ (3,893,743)||(8,527,341)||$ (14,230,821)||$ (293,799,824)|
|Other comprehensive loss, net of tax:|
|Foreign currency translation adjustments||2,864||5,345||(2,019)||2||(58,864)|
|Comprehensive loss||$ (2,375,904)||$(3,888,398)||$ (8,529,360)||$ (14,230,819)||$ (293,858,688)|