SAN DIEGO, Aug. 8, 2013 (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), today announced financial results for the second quarter ended June 30, 2013 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, 2013, which was filed with the Securities and Exchange Commission on August 8, 2013 and is available through investors.medicinova.com/sec.cfm.
For the quarter ended June 30, 2013, MediciNova reported a net loss of $2.8 million, or $0.14 per share (20.3 million shares used to compute loss per share), compared to a net loss of $2.3 million, or $0.14 per share (16.1 million shares used to compute loss per share), for the same period last year. For the quarter ended June 30, 2012, the Company recorded revenue relating to services performed under an agreement with Kissei Pharmaceutical Co., Ltd., or Kissei, of $0.5M. We had no services revenue in the most recent quarter. Research and development expenses were $0.9 million for the quarter ended June 30, 2013, as compared to $1.5 million for the quarter ended June 30, 2012. The decrease in research and development expenses was due primarily to a decrease in spending on our MN-221-CL-007 trial resulting from its completion in 2012, and no spending for Kissei related services, partially offset by an increase in stock-based employee compensation expense. General and administrative expenses were $1.8 million for the quarter ended June 30, 2013, as compared to $1.3 million for the quarter ended June 30, 2012. The increase in general and administrative expenses was due primarily to an increase in stock-based employee compensation expense.
At June 30, 2013, we had available cash and cash equivalents of $12.0 million and working capital of $11.4 million. Between August 21, 2012, the date of the Common Stock Purchase Agreement with Aspire Capital Fund, LLC, or Aspire, and June 30, 2013, we have generated net proceeds of $5.3 million under this agreement. We have not made additional sales of our common to stock to Aspire subsequent to June 30, 2013 through today's date. Between April 17, 2013, the date of the Market Equity Distribution Agreement with Macquarie Capital (USA) Inc., or MCUSA, and June 30, 2013, we have generated net proceeds of $5.1 million under this agreement. We have generated additional net proceeds of $0.4 million under this agreement subsequent to June 30, 2013 through today's date. In the second quarter we also closed a private placement with certain institutional investors generating net proceeds of $3.4 million.
- On July 18, 2013 MediciNova announced the initiation of a cooperative Phase 2b trial with MN-166 (ibudilast) in progressive multiple sclerosis. The study is a unique collaboration of medical centers, the National Multiple Sclerosis Society and MediciNova, with primary funding by an $11.3 million grant from the National Institute of Health. The principal investigator will be Robert Fox, M.D., M.S., FAAN, Staff Neurologist at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic.
- On June 18, 2013 UCLA presented preliminary results from a Phase 1b study of MediciNova's MN-166 in methamphetamine addiction at the 75th Annual Meeting of the College on Problems of Drug Dependence. MN-166 was featured in both a poster session and a symposium on glial attenuators and their role in drug abuse.
- On May 14, 2013, MediciNova closed a private placement with certain institutional investors generating gross proceeds of $3.7 million through the sale of 1,158,730 shares of our common stock and warrants to purchase 750,000 and 119,047 shares of our common stock with an exercise price of $3.15 per share and $3.38 per share, respectively.
- On April 17, 2013, MediciNova entered into an At-the-Market Equity Distribution Agreement with MCUSA which allows the Company to sell from time to time through MCUSA shares of our common stock up to an aggregate offering price of $6 million. Through today's date, sales of shares of our common stock under this agreement have generated gross proceeds of the entire $6 million.
"We are very excited about the achievement of several major milestones this quarter with the encouraging MN-166 clinical data in methamphetamine addiction and most recently the NIH NeuroNEXT grant award for a MN-166 Phase 2b trial in progressive MS," said Yuichi Iwaki, M.D., Ph.D, President and Chief Executive Officer of MediciNova, Inc. "We believe we are well positioned as a company to advance our development programs and to continue to execute successfully on our milestone goals."
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|
|June 30,||December 31,|
|Cash and cash equivalents||$12,017,480||$4,010,530|
|Prepaid expenses and other current assets||480,161||411,592|
|Total current assets||12,497,641||4,422,122|
|In-process research and development||4,800,000||4,800,000|
|Investment in joint venture||673,374||667,204|
|Property and equipment, net||105,513||78,474|
|Liabilities and Stockholders' Equity|
|Accrued compensation and related expenses||490,810||228,124|
|Current deferred revenue||—||3,163|
|Total current liabilities||1,075,633||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 June 30, 2013 and December 31, 2012; 220,000 shares issued at June 30, 2013 and December 31, 2012||2,200||2,200|
|Common stock, $0.001 par value; 100,000,000 shares authorized at June 30, 2013 and December 31, 2012; 22,148,493 and 17,407,311 shares issued at June 30, 2013 and December 31, 2012, respectively, and 22,148,493 and 17,403,125 shares outstanding at June 30, 2013 and December 31, 2012, respectively||22,149||17,407|
|Additional paid-in capital||325,568,447||312,293,225|
|Accumulated other comprehensive loss||(78,594)||(67,957)|
|Treasury stock, at cost; 0 shares at June 30, 2013 and 4,186 shares at December 31, 2012||(1,124,389)||(1,131,086)|
|Deficit accumulated during the development stage||(301,438,840)||(296,233,797)|
|Total stockholders' equity||22,950,973||14,879,992|
|Total liabilities and stockholders' equity||$27,676,769||$19,568,041|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three months ended||Six months ended||Period from|
|June 30,||June 30,||September 26,|
|to June 30,|
|Revenues||$ —||$ 493,623||$3,257||$684,797||$2,364,064|
|Cost of revenues||—||—||—||—||1,258,421|
|Research and development||946,105||1,483,939||1,642,077||3,362,400||168,696,732|
|General and administrative||1,842,092||1,297,888||3,566,671||3,483,860||115,824,039|
|Total operating expenses||2,788,197||2,781,827||5,208,748||6,846,260||285,779,192|
|Impairment charge on investment securities||—||—||—||—||(1,735,212)|
|Loss before income taxes||(2,784,240)||(2,281,350)||(5,204,499)||(6,148,573)||(269,999,213)|
|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||($2,786,029)||($2,281,350)||($5,205,043)||($6,148,573)||($301,438,840)|
|Basic and diluted net loss per common share||($0.14)||($0.14)||($0.27)||($0.38)|
|Shares used to compute basic and diluted net loss per common share||20,299,164||16,143,125||19,002,419||16,115,570|
|Net loss applicable to common stockholders||($2,786,029)||($2,281,350)||($5,205,043)||($6,148,573)||($301,438,840)|
|Other comprehensive loss, net of tax:|
|Foreign currency translation adjustments||(3,724)||1,905||(10,637)||(4,883)||(78,594)|
CONTACT: INVESTOR CONTACT: Geoff O'Brien Senior Director, Business Development and Strategic Planning MediciNova, Inc. firstname.lastname@example.org