Other Recent Highlights
- On April 17, 2013, MediciNova entered into an At-the-Market Equity Distribution Agreement with Macquarie Capital (USA) Inc. ("MCUSA") pursuant to which the Company may from time to time sell through MCUSA shares of our common stock up to an aggregate offering price of $6 million.
- On February 25, 2013 MediciNova announced that it had received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ibudilast (MN-166) for the treatment of methamphetamine dependence. Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and have the potential to fill an unmet medical need.
- On January 3, 2013 MediciNova provided a development update on its lead program, MN-166, and on the MN-221 program. The company provided an update on its grant aided ibudilast (MN-166) neurological development program, which has trials ongoing in opioid dependence and methamphetamine dependence. The company also described the guidance it received from its MN-221 End-of-Phase 2 Meeting with the FDA including the next steps in manufacturing and clinical development, which will be partner-dependent.
"MediciNova's progress in early 2013 has been very encouraging. For MN-166 we were very pleased with its Fast Track designation for development in methamphetamine dependence and with MN-221 we were able to utilize the helpful guidance from FDA to construct its development path forward for the treatment of acute asthma," said Yuichi Iwaki, M.D., Ph.D, President and Chief Executive Officer of MediciNova, Inc. "We believe we are well positioned to continue this progress in 2013 and the value that can provide for our shareholders."
MediciNova, Inc. is a publicly traded biopharmaceutical company founded upon developing novel, small-molecule therapeutics for the treatment of diseases with unmet need with a commercial focus on the U.S. market. MediciNova's current strategy is to focus on its prioritized product candidate, MN-166 (ibudilast) for neurological disorders. MN-166 is being developed in Phase 1 and Phase 2 clinical trials for drug dependence and pain, largely through investigator sponsored trials and outside funding. Proceeding with proof-of-concept Phase 2b trial(s) in Progressive MS is dependent on receipt of funding, which we are pursuing. MediciNova is engaged in strategic partnering and consortium funding discussions to support further development of the ibudilast/MN-166 program and to continue the development progress of MN-221 for the treatment of acute exacerbations of asthma. For more information on MediciNova, Inc., please visit www.medicinova.com .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, the implication of patent terms and potential product exclusivity and the implication 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 of obtaining future partner or grant funding for development of MN-166 and MN-221 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, 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 obtain third party funding for programs and 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, 2012 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|
|March 31 2013||December 31, 2012|
|Cash and cash equivalents||$ 3,029,064||$ 4,010,530|
|Prepaid expenses and other current assets||683,582||411,592|
|Total current assets||3,712,646||4,422,122|
|In-process research and development||4,800,000||4,800,000|
|Investment in joint venture||662,920||667,204|
|Property and equipment, net||69,906||78,474|
|Total assets||$ 18,845,713||$ 19,568,041|
|Liabilities and Stockholders' Equity|
|Accounts payable||$ 269,858||$ 491,853|
|Accrued compensation and related expenses||246,333||228,124|
|Current deferred revenue||—||3,163|
|Total current liabilities||948,150||1,037,792|
|Deferred tax liability||1,956,000||1,956,000|
|Long-term deferred revenue||1,694,163||1,694,257|
|Preferred stock, $0.01 par value; 3,000,000 shares authorized at March 31, 2013 and December 31, 2012 ; 220,000 shares issued at March 31, 2013 and December 31, 2012||2,200||2,200|
|Common stock, $0.001 par value; 100,000,000 shares authorized at March 31, 2013 and December 31, 2012 ; 18,260,569 and 17,407,311 shares issued at March 31, 2013 and December 31, 2012, respectively, and 18,260,569 and 17,403,125 shares outstanding at March 31, 2013 and December 31, 2012, respectively||18,261||17,407|
|Additional paid-in capital||314,079,009||312,293,225|
|Accumulated other comprehensive loss||(74,870)||(67,957)|
|Treasury stock, at cost; 0 shares at March 31, 2013 and 4,186 shares at December 31, 2012||(1,124,389)||(1,131,086)|
|Deficit accumulated during the development stage||(298,652,811)||(296,233,797)|
|Total stockholders' equity||14,247,400||14,879,992|
|Total liabilities and stockholders' equity||$ 18,845,713||$ 19,568,041|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three months ended March 31,||Period from September 26, 2000 (inception) to March 31, 2013|
|Revenues||$ 3,257||$ 191,174||$ 2,364,064|
|Cost of revenues||—||—||1,258,421|
|Research and development||695,972||1,878,461||167,750,627|
|General and administrative||1,724,579||2,185,972||113,981,947|
|Total operating expenses||2,420,551||4,064,433||282,990,995|
|Impairment charge on investment securities||—||—||(1,735,212)|
|Loss before income taxes||(2,420,259)||(3,867,223)||(267,214,973)|
|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||$ (2,419,014)||$ (3,867,223)||$ (298,652,811)|
|Basic and diluted net loss per common share||$ (0.14)||$ (0.24)|
|Shares used to compute basic and diluted net loss per common share||17,691,266||16,088,015|
|Net loss applicable to common stockholders||$ (2,419,014)||$ (3,867,223)||$ (298,652,811)|
|Other comprehensive loss, net of tax:|
|Foreign currency translation adjustments||(6,913)||(6,788)||(74,870)|
|Comprehensive loss||$ (2,425,927)||$ (3,874,011)||$ (298,727,681)|
CONTACT: INVESTOR CONTACT: Mike Coffee Chief Business Officer MediciNova, Inc. (858) 736-7180 firstname.lastname@example.org
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