Minerva Neurosciences Reports Second Quarter 2016 Financial Results and Business Updates
Positive clinical data advance development with MIN-101 in schizophrenia and MIN-117 in major depressive disorder
Additional trials also planned with MIN-202 in insomnia disorder and major depressive disorder
"Positive data announced during the second quarter of 2016 reinforced the differentiated product profiles of MIN-101 and MIN-117 that have the potential to address substantial unmet needs in schizophrenia and major depressive disorder (MDD)," said Dr.
The Company also completed a public offering of shares of common stock on
- The primary endpoint of improvement in negative symptoms was achieved in a Phase IIb, 12-week, randomized, double-blind, placebo-controlled parallel trial of two daily doses of MIN-101, 32 milligrams (mg) and 64 mg, in 244 patients with schizophrenia.
- Consistent and statistically significant improvements were demonstrated in multiple secondary endpoints, including overall symptomatology and cognition as measured by a number of rating scales. Positive symptoms were observed to remain stable.
- The absence of extra-pyramidal symptoms supports the direct and specific effect of MIN-101 on negative symptoms rather than an indirect effect mediated by improvements of positive symptoms.
- MIN-101 was reported to be well tolerated, and the incidence and types of side effects did not differ significantly between the MIN-101 and placebo groups. No metabolic adverse effects and no weight gain were observed. Two patients out of 162 who received MIN-101 were discontinued based on QTcF prolongation (both on the higher dose).
- A number of patients who completed the 12-week double-blind core phase of this study have entered an ongoing 24-week, open-label extension phase during which all patients are receiving one of the two doses of MIN-101. The extension phase is expected to conclude in the third quarter of 2016. Thereafter, the Company plans to meet with regulatory authorities regarding the design of pivotal clinical trials.
- The primary endpoint of improvement in depressive symptomatology was achieved in a four-arm, parallel-group, randomized double-blind, placebo- and positive-control Phase IIa trial which tested two daily doses of MIN-117, 0.5 mg and 2.5 mg, in 84 patients with moderate to severe MDD.
- Improvements in depressive symptomatology and in anxiety were initially observed at two weeks following initiation of treatment. Prospectively defined remission in symptoms was achieved by 24 percent of patients treated with the 2.5 mg dose.
- Pharmacodynamic measurements showed that MIN-117 preserved sleep continuity and architecture and had no detrimental effects on rapid eye movement sleep distribution and duration.
- Both doses demonstrated a favorable tolerability profile, and the incidence and types of side effects did not differ significantly between MIN-117 and placebo. No unexpected adverse events were reported, and treatment with MIN-117 was not associated with cognitive impairment, sexual dysfunction, suicidal ideation or weight gain.
- As established prospectively, this trial was designed for signal detection and effect size estimation and was not powered to demonstrate statistically significant differences between MIN-117 and placebo.
- Earlier this year, Minerva released positive data from a Phase IIa trial with MIN-202 in insomnia disorder and a Phase Ib trial in MDD.
- In the Phase IIa trial, patients treated with MIN-202 were observed to have statistically significant improvements in multiple key sleep parameters, compared to patients treated with placebo. These included sleep efficiency as measured by objective polysomnography, the primary endpoint of the trial.
- In the Phase Ib trial in MDD, treatment with MIN-202 was observed to result in consistent improvements in the symptoms of depression in MDD patients. These improvements support the potential of MIN-202 to have a direct effect on mood independent from its effect on sleep.
- Minerva and
Janssenare planning the next steps in the clinical development program for MIN-202, including potential Phase IIb clinical trials in both insomnia disorder and MDD.
- Building upon data from a non-human primate study with an analog of MIN-301, Minerva is continuing to conduct pre-clinical development and manufacturing scale-up activities with MIN-301 as a treatment for Parkinson's disease.
- We expect that the next steps in the MIN-301 program, after completion of the regular toxicology studies and final production of the GMP batch, will include filing an Investigational New Drug application (IND) and/or Investigational Medicinal Product Dossier (IMPD), with a Phase 1 study to commence upon acceptance by the
U.S. Food and Drug Administration(FDA).
Second Quarter 2016 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities as of
June 30, 2016were approximately $97.1 million, compared to $32.2 millionas of December 31, 2015. Minerva expects that its cash, cash equivalents and marketable securities on hand at June 30, 2016will be sufficient to fund its operations into 2018.
- R&D Expenses: Research and development (R&D) expenses were
$2.7 millionin the second quarter of 2016, compared to $4.5 millionin the second quarter of 2015. For the six months ended June 30, 2016, R&D expenses were $8.1 million, compared to $8.4 millionfor the six months ended June 30, 2015.
R&D expense in the three months ended
June 30, 2016and 2015 included non-cash stock-based compensation expenses of $0.2 millionin both periods. Excluding stock-based compensation, total R&D expense related to drug development programs for the three months ended June 30, 2016and 2015 was $2.5 millionand $4.3 million, respectively, a decrease of $1.8 million. This decrease in R&D expense primarily reflects lower development expenses on MIN-202 as we fulfilled our funding obligation under the co-development agreement for the current development phase, the completion of the 12-week double-blind core phase of our Phase IIb clinical trial of MIN-101 and completion of our Phase IIa clinical trial of MIN-117. These amounts were partially offset by increased personnel costs.
R&D expense in the six months ended
June 30, 2016and 2015 included non-cash stock-based compensation expenses of $0.5 millionand $0.2 million, respectively. Excluding stock-based compensation, total R&D expense related to drug development programs for the six months ended June 30, 2016and 2015 was $7.6 millionand $8.2 million, respectively, a decrease of $0.6 million. This decrease in R&D expense primarily reflects lower development expenses on MIN-202 as we fulfilled our funding obligation under the co-development agreement for the current development phase. These amounts were partially offset by increased expenses related to our Phase IIa clinical trial of MIN-117, our Phase IIb clinical trial of MIN-101, and increased personnel costs.
- G&A Expenses: General and administrative (G&A) expenses were
$2.3 millionin the second quarter of 2016, compared to $1.8 millionin the second quarter of 2015. For the six months ended June 30, 2016, G&A expenses were $4.6 million, compared to $3.8 millionfor the same period in 2015.
G&A expense in the three months ended
June 30, 2016and 2015 included non-cash stock-based compensation expenses of $0.6 millionand $0.4 million, respectively. Excluding stock-based compensation, G&A expense for the three months ended June 30, 2016and 2015 was $1.7 millionand $1.4 million, respectively.
G&A expense in the six months ended
June 30, 2016and 2015 included non-cash stock-based compensation expenses of $1.2 millionand $0.6 million, respectively. Excluding stock-based compensation, G&A expense for the six months ended June 30, 2016and 2015 was $3.4 millionand $3.2 million, respectively.
The increases in G&A expenses for the three and six months ended
June 30, 2016were primarily due to an increase in personnel costs and professional fees.
- Net Loss: Net loss was
$5.2 millionfor the second quarter of 2016, or a loss per share of $0.18(basic and diluted), as compared to a net loss of $6.6 million, or a loss per share of $0.27(basic and diluted) for the second quarter of 2015. Net loss was $13.2 millionfor the first six months of 2016, or a loss per share of $0.47(basic and diluted), as compared to a net loss of $12.7 million, or a loss per share of $0.58(basic and diluted) for the first six months of 2015.
Conference Call Information:
The live webcast can be accessed under "Events and Presentations" in the Investors and Media section of Minerva's website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management's expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements
include statements herein with respect to the timing and results of future clinical and pre-clinical milestones with MIN-101, MIN-202, MIN-117 and MIN-301; the timing of future clinical trials and results of clinical trials with these compounds; the clinical and therapeutic potential of these compounds; our ability to successfully develop and commercialize our therapeutic products; the sufficiency of our current cash position to fund our operations; and management's ability to successfully achieve its goals. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether any of our therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the
|CONDENSED CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$||88,670||$||14,284|
|Prepaid expenses and other current assets||278||1,196|
|Total current assets||97,415||33,481|
|In-process research and development||34,200||34,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Notes payable - current portion||$||3,879||$||1,435|
|Accrued expenses and other current liabilities||1,483||2,525|
|Total current liabilities||6,239||5,320|
|Notes payable - noncurrent||6,225||8,503|
|Additional paid-in capital||235,632||157,130|
|Total stockholders' equity||120,604||55,319|
|Total Liabilities and Stockholders' Equity||$||146,502||$||82,576|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended ||Six Months Ended |
|(in thousands, except per share
|(in thousands, except per share |
|Research and development||2,714||4,485||8,089||8,446|
|General and administrative||2,250||1,847||4,632||3,765|
|Total operating expenses||4,964||6,332||12,721||12,211|
|Foreign exchange (losses)/gains||(16||)||(29||)||(25||)||(13||)|
|Loss per share:|
|Basic and diluted||$||(0.18||)||$||(0.27||)||$||(0.47||)||$||(0.58||)|
|Weighted average shares:|
|Basic and diluted||29,122||24,721||28,163||22,084|
William B. BoniVP, Investor Relations/ Corp. Communications Minerva Neurosciences, Inc.(617) 600-7376
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