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. |
CONSOLIDATED BALANCE
SHEETS |
|
|
|
|
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) |
|
|
Three months
ended June 30, |
Six months ended
June 30, |
Period from September 26,
2000 (inception) to June 30, |
|
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) |
CONTACT: INVESTOR CONTACT:
Mark Johnson
Investor Relations
MediciNova, Inc.
(858) 373-1300
johnson@medicinova.com
MEDIA CONTACT:
Stephanie Ashe
Continuum Health Communications
650-245-0425
sashe@continuumhealthcom.com
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