Minerva Neurosciences Reports First Quarter 2020 Financial Results and Business Updates
May 04 2020 - 6:30AM
Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage
biopharmaceutical company focused on the development of therapies
to treat central nervous system (CNS) disorders, today reported key
business updates and financial results for the quarter ended March
31, 2020.
“We are pleased to report that we are approaching the conclusion
of the double-blind, 12-week phase of our pivotal Phase 3 trial
with roluperidone and reiterate our previous guidance that we
expect to report top line results in the second quarter,” said Dr.
Remy Luthringer, Executive Chairman and Chief Executive Officer of
Minerva. “Progress in this trial has been unaffected to date by the
coronavirus pandemic and we are continually monitoring each trial
site and our contract research organizations to ensure the safety
of all patients and their access to study drug,” said Dr.
Luthringer. “The last patient visit has taken place in the
double-blind phase of the trial, in which a total of 515 patients
were enrolled. In total, 362 patients have completed the
double-blind phase, 333 patients from the double-blind phase have
elected to transition into the open-label extension period, and 92
patients have completed the extension phase as of April 30,
2020.
“Finally, the prominent role of negative symptoms in
schizophrenia has been increasingly highlighted by the key opinion
leader (KOL) community since we initiated the Phase 3 trial,” said
Dr. Luthringer. “Our recent KOL webcast, which included the
participation of Dr. Stephen Marder, Dr. William Carpenter, Dr.
Ofer Agid and Dr. John Kane, discussed how roluperidone may play an
important role in treating the negative symptoms of schizophrenia,
which persist and worsen over the lifetimes of the majority of
patients, accounting for their functional disability and severely
limiting their social and vocational reintegration over the long
term.”
Clinical Development Updates
Roluperidone (MIN-101):
Following the completion of enrollment in a pivotal Phase 3
trial with roluperidone (clinicaltrials.gov identifier:
NCT033971340) to treat negative symptoms in schizophrenia in
February 2020, top-line results from this trial are expected in the
second quarter of 2020, consistent with previous guidance. In
parallel with completing this trial, the Company is advancing
preparatory work for regulatory filing and commercialization,
including clinical pharmacology studies, manufacturing of
registration batches of the drug, medical affairs,
commercialization strategy and product launch planning.
Seltorexant (MIN-202)
The Company and its co-development and co-commercialization
partner, Janssen Pharmaceutica NV, met recently with the U.S. Food
and Drug Administration (FDA) to discuss the Phase 3 program for
seltorexant based on findings from trials with seltorexant
completed in 2019. The two companies are consulting with each
other and with the FDA and the European Medicines Agency/ Committee
for Medicinal Products for Human Use about a target indication
of adjunctive Major Depressive Disorder (aMDD) in patients with
insomnia symptoms and clinical trials to support that target
indication.
First Quarter 2020 Financial Results
- Net Loss: Net loss was $12.2 million for
the first quarter of 2020, or a loss per share of $0.31 (basic and
diluted), compared to a net loss of $15.8 million for the first
quarter of 2019, or a loss per share of $0.41 (basic and
diluted).
- R&D Expenses: Research and development
(R&D) expenses were $8.1 million in the first quarter of 2020,
compared to $11.6 million in the first quarter of 2019. The
decrease in R&D expenses primarily reflects lower 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 decrease during 2020 with the completion of the Phase 2b trial
of MIN-117 and the 12-week, double-blind portion of the Phase 3
clinical trial of roluperidone.
- G&A Expenses: General and administrative
(G&A) expenses were $4.2 million in the first quarter of 2020,
compared to $4.7 million in the first quarter of 2019. This
decrease in G&A expenses was primarily due to a decrease in
non-cash stock-based compensation expenses and a decrease in
professional fees.
- Cash Position: Cash, cash equivalents,
restricted cash and marketable securities as of March 31, 2020 were
approximately $37.6 million.
Conference Call Information:
Minerva Neurosciences will host a conference call and live audio
webcast today at 8:30 a.m. Eastern Time to discuss the quarter and
recent business activities. To participate, please dial (877)
312-5845 (domestic) or (765) 507-2618 (international) and refer to
conference ID 3969525.
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 Minerva Neurosciences
Minerva’s proprietary compounds include: roluperidone (MIN-101),
in clinical development for schizophrenia; seltorexant (MIN-202 or
JNJ-42847922), in clinical development for insomnia and MDD; 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 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 future clinical trials and results of clinical trials with
roluperidone (MIN-101) and seltorexant (MIN-202); the clinical and
therapeutic potential of these compounds; the timing and outcomes
of future interactions with U.S. and foreign regulatory bodies; our
ability to successfully develop and commercialize our therapeutic
products; the sufficiency of our current cash position to fund our
operations; management’s ability to successfully achieve its goals;
and the impact of the coronavirus (COVID-19) pandemic. 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 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 U.S. Food and Drug Administration or equivalent
foreign regulatory agencies and for which indications; whether any
of our therapeutic products will be successfully marketed if
approved; whether any of our therapeutic product discovery and
development efforts will be successful; management’s ability to
successfully achieve its goals; our ability to raise additional
capital to fund our operations on terms acceptable to us; and
general economic conditions. These and other potential risks
and uncertainties that could cause actual results to differ from
the results predicted are more fully detailed under the caption
“Risk Factors” in our filings with the Securities and Exchange
Commission, including our Quarterly Report on Form 10-Q for the
quarter ended March 31, 2020, filed with the Securities
and Exchange Commission on May 4, 2020. Copies of reports
filed with the SEC are posted on our website at
www.minervaneurosciences.com. The forward-looking statements in
this press release are based on information available to us as of
the date hereof, and we disclaim any obligation to update any
forward-looking statements, except as required by law.
CONDENSED
CONSOLIDATED BALANCE SHEET DATA |
(Unaudited) |
|
March
31, |
December 31, |
|
|
2020 |
|
|
2019 |
|
|
(in
thousands) |
ASSETS |
Current
Assets: |
|
|
Cash and cash equivalents |
$ |
30,036 |
|
$ |
21,413 |
|
Marketable securities |
|
7,478 |
|
|
24,442 |
|
Restricted cash |
|
100 |
|
|
100 |
|
Prepaid
expenses and other current assets |
|
852 |
|
|
1,182 |
|
Total
current assets |
|
38,466 |
|
|
47,137 |
|
Equipment, net |
|
12 |
|
|
16 |
|
Other
noncurrent assets |
|
15 |
|
|
15 |
|
Operating
lease right-of-use assets |
|
224 |
|
|
262 |
|
In-process research and development |
|
15,200 |
|
|
15,200 |
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
Total
Assets |
$ |
68,786 |
|
$ |
77,499 |
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY |
Current
Liabilities: |
|
|
Accounts
payable |
$ |
3,003 |
|
$ |
2,317 |
|
Accrued
expenses and other current liabilities |
|
3,936 |
|
|
4,139 |
|
Operating
leases |
|
179 |
|
|
173 |
|
Total
current liabilities |
|
7,118 |
|
|
6,629 |
|
Long-Term
Liabilities: |
|
|
Deferred
taxes |
|
1,803 |
|
|
1,803 |
|
Deferred
revenue |
|
41,176 |
|
|
41,176 |
|
Noncurrent operating leases |
|
64 |
|
|
111 |
|
Total
liabilities |
|
50,161 |
|
|
49,719 |
|
Stockholders' Equity: |
|
|
Common
stock |
|
4 |
|
|
4 |
|
Additional paid-in capital |
|
317,508 |
|
|
314,512 |
|
Accumulated deficit |
|
(298,887 |
) |
|
(286,736 |
) |
Total
stockholders' equity |
|
18,625 |
|
|
27,780 |
|
Total
Liabilities and Stockholders' Equity |
$ |
68,786 |
|
$ |
77,499 |
|
|
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
(Unaudited) |
|
|
|
|
|
Three Months
Ended March 31, |
|
|
(in
thousands, except per share amounts) |
|
|
|
2020 |
|
|
2019 |
|
|
|
|
|
Revenues |
|
$ |
- |
|
$ |
- |
|
Operating
expenses: |
|
|
|
Research
and development |
|
|
8,083 |
|
|
11,606 |
|
General
and administrative |
|
|
4,189 |
|
|
4,706 |
|
Total
operating expenses |
|
|
12,272 |
|
|
16,312 |
|
|
|
|
|
Foreign
exchange losses |
|
|
(9 |
) |
|
(6 |
) |
Investment income |
|
|
130 |
|
|
491 |
|
Net
(loss) income |
|
$ |
(12,151 |
) |
$ |
(15,827 |
) |
Loss per
share: |
|
|
|
Basic and
diluted |
|
$ |
(0.31 |
) |
$ |
(0.41 |
) |
Weighted
average shares: |
|
|
|
Basic and
diluted |
|
|
39,178 |
|
|
38,968 |
|
|
|
|
|
Contact: William B. BoniVP, Investor
Relations/Corp. CommunicationsMinerva Neurosciences, Inc.(617)
600-7376
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