Minerva Neurosciences Reports Third Quarter 2018 Financial Results and Business Updates
Data readouts from five ongoing late-stage trials expected in 2019
“Over the last quarter, we have continued to enroll patients into five clinical trials with roluperidone (MIN-101), seltorexant (MIN-202) and MIN-117,” said Dr.
“All other trials are proceeding on schedule with existing data readout timelines, as we have previously guided,” said Dr. Luthringer. “We believe that each of our clinical-stage product candidates has the potential to have a meaningful impact on the CNS therapeutic landscape and improve the quality of life of patients and their families.”
Summary of ongoing clinical trials with the Company’s products:
- Roluperidone: Phase 3 trial to treat negative symptoms in patients diagnosed with schizophrenia (monotherapy); top line results from the 12-week double blind phase of this trial are expected in mid-2019.
- MIN-117: Phase 2b trial to treat patients with major depressive disorder who also have symptoms of anxiety (monotherapy); top-line results are expected in the first half of 2019.
- Seltorexant (MIN-202): two Phase 2b trials to treat patients with major depressive disorder (adjunctive therapy); results expected in 2019.
- Seltorexant: one Phase 2b trial to treat patients with insomnia disorder (monotherapy); results expected in 2019.
Third Quarter 2018 Financial Results
- Cash Position: Cash, cash equivalents, restricted cash and marketable securities as of
September 30, 2018 were approximately$97.7 million , compared to$133.3 million as ofDecember 31, 2017 .
- R&D Expenses: Research and development (R&D) expenses for the three and nine months ended
September 30, 2018 were$8.4 million and$25.9 million , respectively, compared to$9.0 million and$23.7 million for the same periods in 2017. This variance in R&D expenses was due to lower development expenses for the seltorexant program due to the Amendment to our Co-Development and License Agreement with Janssen, which was partially offset by higher development expenses for the Phase 3 clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117.
R&D expenses are expected to increase during 2018 in connection with increased patient enrollment and related support activities for the roluperidone and MIN-117 clinical trials.
- G&A Expenses: General and administrative (G&A) expenses for the three and nine months ended
September 30, 2018 were$4.1 million and$12.2 million , respectively, compared to$2.5 million and$7.9 million for the same periods in 2017. This increase in G&A expenses was primarily due to an increase in non-cash stock-based compensation expenses and salary costs from increased staffing to support pre-commercial activities.
G&A expenses are expected to increase during 2018 as the Company begins to invest in the infrastructure necessary to support its growth.
- Net Loss: The Company reported a net loss for the three and nine months ended
September 30, 2018 of$12.0 million and$37.0 million respectively, or$0.31 and$0.95 per share, respectively, compared to$11.3 million and$31.7 million , respectively, or$0.28 and$0.84 per share, respectively, for the same period in 2017.
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.
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 scope of current clinical trials and results of clinical trials with roluperidone, seltorexant, MIN-117 and MIN-301; the timing and scope 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 roluperidone, seltorexant, MIN-117 and MIN-301 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) | ||||||
| September 30, | December 31, | |||||
| 2018 | 2017 | |||||
| (in thousands) | ||||||
| ASSETS | ||||||
| Current Assets: | ||||||
| Cash and cash equivalents | $ | 87,296 | $ | 26,052 | ||
| Marketable securities | 10,309 | 102,109 | ||||
| Restricted cash | 100 | 80 | ||||
| Prepaid expenses and other current assets | 3,700 | 1,299 | ||||
| Total current assets | 101,405 | 129,540 | ||||
| Marketable securities - noncurrent | - | 5,023 | ||||
| Equipment, net | 38 | 51 | ||||
| Other noncurrent assets | 15 | 15 | ||||
| In-process research and development | 34,200 | 34,200 | ||||
| Goodwill | 14,869 | 14,869 | ||||
| Total Assets | $ | 150,527 | $ | 183,698 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current Liabilities: | ||||||
| Notes payable | $ | - | $ | 3,962 | ||
| Accounts payable | 875 | 1,436 | ||||
| Accrued expenses and other current liabilities | 2,996 | 1,439 | ||||
| Total current liabilities | 3,871 | 6,837 | ||||
| Long-Term Liabilities: | ||||||
| Deferred taxes | 4,057 | 4,057 | ||||
| Deferred revenue | 41,176 | 41,176 | ||||
| Other noncurrent liabilities | 30 | 30 | ||||
| Total liabilities | 49,134 | 52,100 | ||||
| Stockholders' Equity: | ||||||
| Common stock | 4 | 4 | ||||
| Additional paid-in capital | 302,739 | 295,975 | ||||
| Accumulated deficit | (201,350 | ) | (164,381 | ) | ||
| Total stockholders' equity | 101,393 | 131,598 | ||||
| Total Liabilities and Stockholders' Equity | $ | 150,527 | $ | 183,698 | ||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||
| (Unaudited) | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||
| (in thousands, except per share amounts) | (in thousands, except per share amounts) | ||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | |||||
| Operating expenses: | |||||||||||||
| Research and development | 8,369 | 8,956 | 25,881 | 23,715 | |||||||||
| General and administrative | 4,055 | 2,451 | 12,221 | 7,923 | |||||||||
| Total operating expenses | 12,424 | 11,407 | 38,102 | 31,638 | |||||||||
| Foreign exchange losses | (11 | ) | (9 | ) | - | (46 | ) | ||||||
| Investment income | 418 | 294 | 1,244 | 508 | |||||||||
| Interest expense | (4 | ) | (138 | ) | (110 | ) | (510 | ) | |||||
| Net income (loss) | $ | (12,021 | ) | $ | (11,260 | ) | $ | (36,968 | ) | $ | (31,686 | ) | |
| Loss per share: | |||||||||||||
| Basic and diluted | $ | (0.31 | ) | $ | (0.28 | ) | $ | (0.95 | ) | $ | (0.84 | ) | |
| Weighted average shares: | |||||||||||||
| Basic and diluted | 38,782 | 40,880 | 38,760 | 37,677 | |||||||||
Contact:
VP, Investor Relations/
Corp. Communications
(617) 600-7376
Source: Minerva Neurosciences, Inc