Minerva Neurosciences Reports First Quarter 2021 Financial Results and Business Updates
Top-line results from the open-label extension of phase 3 monotherapy trial of roluperidone for the treatment of negative symptoms of schizophrenia show continuous improvement in negative symptoms, improved functional ability, favorable safety profile and limited number of psychotic relapses over one year
Pivotal bioequivalence study initiated
- Continuous improvement in negative symptoms as measured by Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptom Factor Score (NSFS) observed over one year (12-week double-blind and 40-week open-label periods) in patients receiving both 64 mg and 32 mg doses;
- Continuous improvement in Personal and Social Performance (PSP) total score over one year, suggesting improvement in patients’ everyday life functioning;
- Favorable safety profile with few serious adverse events and no evidence of somnolence, extrapyramidal side effects or weight gain;
- Limited number of relapses observed over one year.
The Company has initiated subject screening in a pivotal bioequivalence study that will include approximately 48 healthy volunteers. This study will compare the formulations employed in the phase 2b and phase 3 trials of roluperidone, as well as at least one new formulation to facilitate large scale manufacturing.
“The results of the open-label extension of the phase 3 trial with roluperidone provide additional support for the continued development of this agent, particularly in an environment with a continuing significant unmet medical need for schizophrenia treatments with novel mechanisms of action,” said Dr.
“In addition, we have initiated the bioequivalence study and are simultaneously moving forward with activities that we believe are necessary to support the submission of a New Drug Application for roluperidone,” said
First Quarter 2021 Financial Results
- Net Loss: Net loss was
$8.8 millionfor the first quarter of 2021, or a loss per share of $0.21(basic and diluted), compared to a net loss of $12.2 millionfor the first quarter of 2020, or a loss per share of $0.31(basic and diluted).
- R&D Expenses: Research and development (R&D) expenses were
$3.3 millionand $8.1 millionfor the three months ended March 31, 2021and 2020, respectively, a decrease of approximately $4.8 million. The decrease in R&D expenses was primarily due to lower costs for the Phase 3 clinical trial of roluperidone as a result of the completion in May 2020of the three-month core study portion of the trial. Non-cash stock compensation expense included in R&D expenses was $0.6 millionand $0.7 millionfor the three months ended March 31, 2021and 2020, respectively.
- G&A Expenses: General and administrative (G&A) expenses were
$4.2 millionfor both the three months ended March 31, 2021and 2020. G&A expenses included compensation costs, consulting expenses, and insurance premiums. Non-cash stock compensation expense included in G&A expenses was $0.9 millionand $1.5 millionfor the three months ended March 31, 2021and 2020, respectively.
- Cash Position: Cash, cash equivalents, and restricted cash at
March 31, 2021were approximately $80.2 million.
Conference Call Information:
The live webcast can be accessed under “Events and Presentations” in the Investors and Media section of Minerva’s website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.
Minerva’s portfolio of compounds includes: roluperidone (MIN-101), in clinical development for schizophrenia, and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit www.minervaneurosciences.com.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with roluperidone (MIN-101); the clinical and therapeutic potential of this compound; the likelihood of successful clinical trials, regulatory review, commercialization, and future sales of and potential royalty stream from seltorexant; the timing and outcomes of future interactions with
|CONDENSED CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$||80,140||$||25,357|
|Prepaid expenses and other current assets||1,449||1,983|
|Total current assets||81,689||27,440|
|Other noncurrent assets||15||15|
|Operating lease right-of-use assets||59||102|
|In-process research and development||15,200||15,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||2,165||2,053|
|Total current liabilities||3,359||3,160|
|Liability related to the sale of future royalties||61,296||-|
|Additional paid-in capital||338,970||337,454|
|Total stockholders' equity||45,374||52,663|
|Total Liabilities and Stockholders' Equity||$||111,832||$||57,626|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended
|(in thousands, except per share amounts)|
|Research and development||3,259||8,083|
|General and administrative||4,249||4,189|
|Total operating expenses||7,508||12,272|
|Loss from operations||(7,508)||(12,272)|
|Foreign exchange losses||(5)||(9)|
|Non-cash interest expense for the sale of future royalties||(1,296)||-|
|Loss before income taxes||(8,805)||(12,151)|
|Benefit for income taxes||-||-|
|Net loss per share, basic and diluted||$||(0.21)||$||(0.31)|
|Weighted average shares outstanding, basic and diluted||42,722||39,178|
VP, Investor Relations/
Source: Minerva Neurosciences, Inc