Minerva Neurosciences Reports Fiscal 2020 Fourth Quarter and Year End Financial Results and Business Updates
Phase 3 open-label extension completed on schedule in patients with negative symptoms of schizophrenia and data will be available in H1 2021
Minerva’s royalty interest in seltorexant acquired by Royalty Pharma for an upfront payment of
Cash, cash equivalents and restricted cash at
Roluperidone, a proprietary orally dosed molecule acting on 5HT2A, Sigma2, and α‑adrenergic receptors, is Minerva’s lead product candidate currently being evaluated in a Phase 3 study as a potential treatment for negative symptoms of schizophrenia.
Following completion of the 12-week double-blind phase of the Phase 3 study in H1 2020, a total of 333 patients (65%) entered the 9-month open-label extension in which those patients already being treated with roluperidone remained on treatment on the same dose received in the 12-week double-blind phase (32mg or 64mg) and those patients who received placebo in the 12-week double-blind phase were randomized to either 32mg or 64mg.
Patient evaluation in the open-label extension phase of the Phase 3 trial of roluperidone was achieved on schedule on
The Company expects the data from the open-label extension will demonstrate whether:
- improvement of negative symptoms is sustained or increased over the one-year duration;
- improvement of negative symptoms leads to improved functioning;
- roluperidone maintains or improves positive symptoms and/or agitation; and
- the safety and tolerability profile of roluperidone is maintained over the one-year administration period.
The Company intends to initiate a pivotal bioequivalence study in approximately 48 healthy volunteers comparing the formulations employed in the Phase 2b and Phase 3 trials as well as at least one new formulation designed in conjunction with its commercial supply partner,
Following the completion of the bioequivalence study, the Company plans to request a pre-NDA meeting with the
“Following our Type C meeting with the
“We are very pleased that a large number of patients chose to enter and completed the open-label extension portion of the Phase 3 trial, data from which have the potential to demonstrate durability of effect and long-term safety of roluperidone,” said
Previously, the Company had exercised its right to opt out of its agreement with Janssen for the Phase 3 development and commercialization of seltorexant. Under this agreement, the Company was entitled to collect a royalty on worldwide sales of seltorexant in all indications in the mid-single digits, with no further future financial obligations to Janssen.
Fourth Quarter and Year Ended 2020 Financial Results
- Net (Loss) Income: Net loss was
$7.3 millionfor the fourth quarter of 2020, or loss per share of $0.17(basic and diluted), compared to net loss of $29.9 millionfor the fourth quarter of 2019, or loss per share of $0.77(basic and diluted). Net income was $1.9 millionfor the year ended December 31, 2020, or income per share of $0.05(basic and diluted), compared to a net loss of $72.2 million, or loss per share of $1.85(basic and diluted) for the year ended December 31, 2019.
Collaborative revenue was
$41.2 millionand $0.0for the years ended December 31, 2020and 2019, respectively. The increase in collaborative revenue was the result of the Company’s exercising its right to opt out of the co-development agreement with Janssen during 2020. As a result of the opt out, the Company has no further performance obligations and recognized the $41.2 millionwhich had previously been included on its balance sheet under deferred revenue.
- R&D Expenses: Research and development (R&D) expenses were
$3.6 millionand $28.5 millionfor the fourth quarters of 2020 and 2019, respectively. R&D expenses were $22.0 millionand $58.1 millionfor the years ended December 31, 2020and 2019, respectively.
The decrease in R&D expense for the fourth quarter ended
December 31, 2020was primarily due to a $19.0 millioncharge taken in December 2019for the impairment of the in-process research and development related to MIN-117 following the results of the Phase 2b trial in MDD which failed to meet its primary and key secondary endpoints. The decrease in R&D expense for the year ended December 31, 2020was due also to approximately $11.0 millionfrom the completion of the Phase 2b clinical trial of MIN-117 in December 2019and the completion of the core study portion of the Phase 3 clinical trial of roluperidone in May 2020. Non-cash stock compensation expense included in R&D expenses was $3.0 millionand $2.6 millionfor the years ended December 31, 2020and 2019, respectively.
- G&A Expenses: General and administrative (G&A) expenses were
$3.7 millionand $3.8 millionfor the fourth quarters of 2020 and 2019, respectively. G&A expenses were $17.3 millionand $17.7 millionfor the years ended December 31, 2020and 2019, respectively.
The decreases in G&A expenses for the fourth quarter and year ended
December 31, 2020were primarily due to lower pre-commercial expenses in 2020, offset by higher insurance costs. Non-cash stock compensation expense included in G&A expenses was $6.7 millionand $6.5 millionfor the years ended December 31, 2020and 2019, respectively.
- Cash Position: Cash, cash equivalents and restricted cash as of
December 31, 2020were approximately $25.5 million, compared to $46.0 millionas of December 31, 2019. In January, 2021, the Company received a $60 millioncash payment from Royalty Pharma in connection with Royalty Pharma’s acquisition of the Company’s royalty interest in seltorexant.
Conference Call Information:
The live webcast can be accessed under “Events and Presentations” in the Investors and Media section of Minerva’s website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.
Minerva’s portfolio of compounds includes: roluperidone (MIN-101), in clinical development for schizophrenia, and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit www.minervaneurosciences.com.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with roluperidone (MIN-101); the clinical and therapeutic potential of this compound; the likelihood of successful clinical trials, regulatory review, commercialization, and future sales of and potential royalty stream from seltorexant; the timing and outcomes of future interactions with
|CONDENSED CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$||25,357||$||21,413|
|Prepaid expenses and other current assets||1,983||1,182|
|Total current assets||27,440||47,137|
|Other noncurrent assets||15||15|
|Operating lease right-of-use assets||102||262|
|In-process research and development||15,200||15,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||2,053||4,139|
|Total current liabilities||3,160||6,629|
|Noncurrent operating leases||-||111|
|Additional paid-in capital||337,454||314,512|
|Total stockholders' equity||52,663||27,780|
|Total Liabilities and Stockholders' Equity||$||57,626||$||77,499|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended
|| Twelve Months Ended
|(in thousands, except per share amounts)||(in thousands, except per share amounts)|
|Research and development||3,551||28,524||22,040||58,123|
|General and administrative||3,748||3,843||17,289||17,741|
|Total operating expenses||7,299||32,367||39,329||75,864|
|(Loss) gain from operations||(7,299||)||(32,367||)||1,847||(75,864||)|
|Foreign exchange losses||(27||)||(11||)||(67||)||(29||)|
|(Loss) income before income taxes||(7,325||)||(32,172||)||1,941||(74,437||)|
|Benefit for income taxes||-||(2,254||)||-||(2,254||)|
|Net (loss) income||(7,325||)||(29,918||)||1,941||(72,183||)|
|Net (loss) income per share, basic||$||(0.17||)||$||(0.77||)||$||0.05||$||(1.85||)|
|Weighted average shares outstanding, basic||42,684||39,037||40,824||39,014|
|Net (loss) income per share, diluted||$||(0.17||)||$||(0.77||)||$||0.05||$||(1.85||)|
|Weighted average shares outstanding, diluted||42,684||39,037||40,917||39,014|
VP, Investor Relations/
Source: Minerva Neurosciences, Inc