Minerva Neurosciences Reports Fourth Quarter and Full Year 2014 Financial Results
- MIN-101 Phase 2b trial for schizophrenia on track -
- Phase 2a trial planned for MIN-202 in primary insomnia in mid-2015; Phase 1b in MDD patients also expected to begin in mid-2015 -
- Company advancing CNS pipeline with MIN-117 and MIN-301 -
- Management to host conference call today at
"We are very pleased to report continued progress for each of our clinical development programs, and are looking forward to several upcoming milestones in 2015 and 2016," commented Dr.
Fourth Quarter and Recent Business Highlights:
Minerva today announced that it received regulatory approval in
Latvia, and ethical committee approvals in Latviaand Estonia, for the Phase 2b study for MIN-101, a serotonin 5-HT2A and sigma2 receptor antagonist for the potential treatment of schizophrenia. The Company submitted an application to run a multi-center, randomized, double-blind, parallel group design study to local authorities in Europein the fourth quarter of 2014, and enrollment is expected to occur in 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 schizophrenic patients with a history of negative symptoms.
December 2014, Minerva also announced the completion of development and final selection of a once-daily dose formulation of MIN-101. The new formulation will be used in the Company's planned Phase 2b clinical trial in schizophrenia and was assessed in a single-center, open-label trial to evaluate the safety, tolerability and pharmacokinetic profiles of several formulations of MIN-101 after administration of single doses of several dosages.
March 2015, Minerva announced that two additional studies for MIN-202 are expected to be initiated in 2015. MIN-202 is a selective orexin-2 antagonist that the Company is developing as part of a collaboration with Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the treatment of primary and comorbid insomnia. 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 major depressive disorder (MDD) with comorbid insomnia which is expected to be initiated in mid-2015.
January 2015, Minerva reported preliminary results from a Phase 1, placebo-controlled, clinical study conducted by Janssenshowing that treatment with MIN-202 resulted in improvements in sleep onset and sleep duration in patients with comorbid insomnia related to MDD.
Janssenalso conducted two additional studies in 2014. The first, a randomized, open-label, three-way crossover Phase 1 study evaluated the bioavailability, food effect, and safety and tolerability of a solid dosage formulation as compared to the liquid formulation used in previous trials in healthy male volunteers, and the second was a double-blind, placebo-controlled, multiple-ascending dose study of several doses of MIN-202 in healthy volunteers.
Minerva also today announced that it received ethical committee approval in
Latviafor a Phase 2a study for MDD in 60 patients, which is expected to begin enrolling in the second quarter of 2015. This will be a randomized, double-blind, parallel-group, placebo and active-controlled study to evaluate the efficacy and safety of 0.5 mg of MIN-117 in adult subjects with MDD. The primary objective is to evaluate the efficacy of this dose compared to placebo in reducing the symptoms of a major depressive episode as measured by the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score over 6 weeks of treatment. Safety and tolerability will also be explored in comparison to the active control paroxetine given at a therapeutic dose of 20 mg/day.
- Minerva today announced that in 2016 it expects to file an Investigational New Drug (IND) or Investigational Medicinal Product Dossier (IMPD) for MIN-301, the Company's investigational neuregulin-1 beta1 compound for the treatment of Parkinson's disease. Following the acceptance of the IND or IMPD, as applicable, Minerva expects to initiate a Phase 1 clinical study.
January 2015, Minerva announced that results from a Primomed (use of PRIMate MOdels to support translational MEDicine) non-human primate study showed that treatment with an analog of MIN-301 resulted in improvements in a range of symptoms associated with Parkinson's disease. The analog used in the Primomed study differs from MIN-301 by a single amino acid.
November 2014, Minerva announced the appointment of Remy Luthringer, Ph.D., president and chief scientific officer, to the additional post of chief executive officer of the Company. Dr. Luthringeralso joined the Board of Directors of Minerva.
Fourth Quarter and Full Year Ended
R&D Expenses: Research and development expenses were
$3.0 millionin the fourth quarter of 2014, compared to $0.2 millionin the same period in 2013. Research and development expenses were $42.9 millionfor the full year ended December 31, 2014, compared to $0.7 millionin the same period in 2013. These increases were primarily due to increased costs related to the Company's four drug development programs, including a $22.0 millionlicense fee paid to Janssenunder the co-development agreement for MIN-202, and increased costs for salaries and stock compensation expense related to additional staff hired during 2014.
G&A Expenses: General and administrative expenses were
$4.5 millionin the fourth quarter of 2014, compared to $1.9 millionin the same period in 2013. General and administrative expenses were $12.0 millionfor the full year ended December 31, 2014, compared to $2.5 millionin the same period in 2013. These increases were primarily due to increased costs related to operations as a public company and increased costs for salaries and stock compensation expense related to additional staff hired during 2014.
Net Loss: Net loss was
$7.4 millionfor the fourth quarter of 2014, or a loss per share of $0.40(basic and diluted), as compared to net loss of $2.1 million, or a loss per share of $0.41(basic and diluted) for the same period in 2013. Net loss was $56.9 millionfor the full year ended December 31, 2014, or a loss per share of $4.47(basic and diluted), as compared to net loss of $3.3 million, or a loss per share of $0.78(basic and diluted) for the same period in 2013.
Cash Position: Cash and cash equivalents as of
December 31, 2014were $18.6 million, compared to $1.8 millionas of December 31, 2013. In January 2015Minerva entered into a term loan with Oxford Financing LLCand Silicon Valley Bank for up to $15.0 million. Under this agreement the Company drew down $10.0 millionin January 2015. In March 2015, Minerva 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 of approximately $28.8 million, net of placement agent fees. Minerva expects that its current cash will fund the Company's operations through 2016.
Conference Call Information:
Forward-Looking Safe-Harbor Statement:
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management's expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the benefits of and our ability to leverage the proceeds of our financings; the timing and results of future clinical milestones; the timing of future clinical trials and results of clinical trials; the clinical and therapeutic potential of our compounds; our ability to successfully develop and commercialize our therapeutic products; and management's ability to successfully achieve its goals. These forward-looking statements are only predictions and may differ
materially from actual results due to a variety of factors including, without limitation, whether any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the
|CONDENSED CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$ 18,546||$ 1,818|
|Total current assets||$ 19,338||$ 1,819|
|In-process research and development||34,200||19,000|
|Deferred public offering costs||--||434|
|Total Assets||$ 68,451||$ 29,174|
|LIABILITIES AND STOCKHOLDERS' DEFICIT|
|Accounts payable||$ 642||$ 523|
|Accrued expenses and other current liabilities||1,645||815|
|Accrued collaborative expenses||1,222||--|
|Convertible promissory notes||--||58|
|Total current liabilities||$ 3,509||$ 1,406|
|Other non-current liabilities||8||--|
|Total liabilities||$ 16,951||$ 8,995|
|Additional paid-in capital||126,229||38,008|
|Total stockholders' deficit||$ 51,500||$ 20,179|
|Total Liabilities and Stockholders' Deficit||$ 68,451||$ 29,174|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
(in thousands, except per
|Revenues||$ --||$ --|
|Research and development||42,909||708|
|General and administrative||11,962||2,467|
|Total operating expenses||54,871||3,175|
|Foreign exchange (gains)/losses||19||(29)|
|Interest expense, net||(2,050)||(58)|
|Net loss||$ (56,902)||$ (3,262)|
|Loss per share:|
|Basic and diluted||$ (4.47)||$ (0.78)|
|Weighted average shares:|
|Basic and diluted||12,724||4,186|
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