Minerva Neurosciences Reports First Quarter 2015 Financial Results and Other Key Business Updates
MIN-101 Phase 2b trial for schizophrenia on track with enrollment underway; new regulatory approvals to conduct trials in
MIN-117 Phase 2a study in Major Depressive Disorder (MDD) on track and expected to begin enrollment in second quarter; additional study arm planned
Management to host conference call today at
"We significantly strengthened our balance sheet by successfully completing equity capital and debt financing in the first quarter of 2015," said Dr.
First Quarter 2015 Key Business Updates:
MIN-101:
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Minerva today announced that to date it has received regulatory approvals in
Latvia ,Estonia ,Romania andRussia and ethical committee approvals inLatvia ,Estonia andRomania for the Phase 2b study for MIN-101, a serotonin 5-HT2A and sigma2 receptor antagonist for the potential treatment of schizophrenia. Enrollment in this trial has begun and is expected to continue through the last three quarters of 2015. This trial is exploring the effect of two doses of MIN-101 given once daily versus placebo in 234 stable schizophrenic patients with a history of negative symptoms.Topline results for the core part of the Phase 2b study are expected to be available in the second quarter of 2016.
MIN-202:
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In
March 2015 , Minerva announced that two additional studies are expected to be initiated in 2015 for MIN-202, a selective orexin-2 antagonist that Minerva is developing as part of a collaboration withJanssen Research & Development, LLC , one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The first is a Phase 2a study in primary insomnia which is expected to be initiated in mid-2015, and the second is a Phase 1b study in patients with MDD with comorbid insomnia which is expected to be initiated in mid-2015.
MIN-117:
- Minerva today announced that it plans to file an amendment to the protocol previously approved by Latvian regulatory authorities for the double blinded placebo controlled Phase 2a study in patients with MDD. The amendment will request an additional patient arm that would evaluate a 2.5mg dose of MIN-117. If the amended protocol is approved, the study is expected to include a total of 80 patients, of which 20 would receive a 0.5mg dose of MIN-117, 20 would receive a 2.5mg dose of MIN-117, 20 would receive a 20mg dose of paroxetine and 20 would receive a placebo. The additional arm would allow us to explore the relative improvement in symptoms between the patients receiving 0.5mg and 2.5mg doses of MIN-117. Minerva plans to begin enrollment for the Phase 2a study in the second quarter of 2015 and expects topline results to be available in the first half of 2016.
MIN-301:
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In
January 2015 , Minerva announced that treatment with an analog of MIN-301, the Company's investigational neuregulin-1 beta1 compound for the treatment of Parkinson's disease, resulted in improvements in a range of symptoms associated with Parkinson's disease in primates. The analog used in the study differs from MIN-301 by a single amino acid. -
In
March 2015 , Minerva announced that it expects to file an Investigational New Drug (IND) or Investigational Medicinal Product Dossier (IMPD) for MIN-301 in 2016. Following the acceptance of the IND or IMPD, as applicable, Minerva expects to initiate a Phase 1 clinical study.
Financings:
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In
January 2015 , Minerva announced that it had entered into a term loan withOxford Financing LLC and Silicon Valley Bank for up to$15.0 million and that it drew down$10.0 million . -
In
March 2015 , Minerva announced that it issued approximately 6.3 million shares of common stock and warrants to purchase an additional approximately 6.3 million shares of common stock in a private placement resulting in net proceeds to the Company of approximately$28.5 million , net of transaction costs.
First Quarter 2015 Financial Results:
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Cash Position: Cash and cash equivalents as of
March 31, 2015 were$52.2 million , compared to$18.5 million as ofDecember 31, 2014 . Minerva expects that its current cash will fund its operations through 2016. -
R&D Expenses: Research and development expenses were
$4.0 million in the first quarter of 2015, compared to$0.6 million in the same period in 2014. The increase was primarily due to program costs of$1.6 million related to MIN-101,$1.5 million in program costs related to MIN-202 and$0.3 million of employee compensation. -
G&A Expenses: General and administrative expenses were
$1.9 million in the first quarter of 2015, compared to$2.0 million in the same period in 2014. The decrease was primarily due to lower consulting fees, offset by higher employee compensation. -
Net Loss: Net loss was
$6.1 million for the first quarter of 2015, or a loss per share of$0.31 (basic and diluted), as compared to net loss of$2.9 million , or a loss per share of$0.43 (basic and diluted) for the same period in 2014.
Conference Call Information:
About
Forward-Looking Safe-Harbor Statement:
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management's expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and results of future clinical milestones; the timing of future clinical trials and results of clinical trials; the clinical and therapeutic potential of our compounds; our ability to successfully develop and commercialize our therapeutic products; the sufficiency of our current cash position to fund our operations; and management's ability to successfully achieve its goals. These forward-looking statements are only predictions and may differ
materially from actual results due to a variety of factors including, without limitation, whether any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the
| CONDENSED CONSOLIDATED BALANCE SHEET DATA | ||
| (Unaudited) | ||
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| 2015 | 2014 | |
| (in thousands) | ||
| ASSETS | ||
| Current Assets: | ||
| Cash and cash equivalents | $ 52,201 | $ 18,546 |
| Restricted cash | 40 | 35 |
| Prepaid expenses | 503 | 757 |
| Total current assets | $ 52,744 | $ 19,338 |
| Equipment, net | 34 | 44 |
| In-process research and development | 34,200 | 34,200 |
| Goodwill | 14,869 | 14,869 |
| Total Assets | $ 101,847 | $ 68,451 |
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||
| Current Liabilities: | ||
| Notes payable - current portion | $ 158 | $ -- |
| Accounts payable | 1,035 | 642 |
| Accrued expenses and other current liabilities | 1,771 | 1,645 |
| Accrued collaborative expenses | 1,461 | 1,222 |
| Total current liabilities | $ 4,425 | $ 3,509 |
| Long-Term Liabilities: | ||
| Notes payable - noncurrent | 9,547 | -- |
| Deferred taxes | 13,434 | 13,434 |
| Other non-current liabilities | 5 | 8 |
| Total liabilities | $ 27,411 | $ 16,951 |
| Stockholders' Deficit: | ||
| Common stock | 2 | 2 |
| Additional paid-in capital | 155,258 | 126,229 |
| Accumulated deficit | (80,824) | (74,731) |
| Total stockholders' deficit | $ 74,436 | $ 51,500 |
| Total Liabilities and Stockholders' Deficit | $ 101,847 | $ 68,451 |
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||
| (Unaudited) | ||
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Three months ended |
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(in thousands, except per share amounts) |
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| 2015 | 2014 | |
| Revenues | $ -- | $ -- |
| Operating expenses: | ||
| Research and development | 3,961 | 586 |
| General and administrative | 1,917 | 2,037 |
| Total operating expenses | 5,878 | 2,623 |
| Foreign exchange (gains)/losses | 16 | (6) |
| Interest expense, net | (231) | (309) |
| Net loss | $ (6,093) | $ (2,938) |
| Loss per share: | ||
| Basic and diluted | $ (0.31) | $ (0.43) |
| Weighted average shares: | ||
| Basic and diluted | 19,417 | 6,903 |
CONTACT: Media contact:
Bill Berry
Berry & Company Public Relations
212-253-8881
bberry@berrypr.com
Investor contact:
Stephanie Ascher
Stern Investor Relations
212-362-1200
stephanie@sternir.com
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