Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage
biopharmaceutical company focused on the development of innovative
therapies to treat central nervous system disorders, today reported
key business updates and financial results for the fourth quarter
and fiscal year ended December 31, 2020.
Program Updates
Roluperidone
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 February
15, 2021, with a total of 202 patients (61%) completing this phase.
Data are expected to be available in the first half of 2021.
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, Catalent, Inc., to facilitate large scale
manufacturing.
Following the completion of the bioequivalence study, the
Company plans to request a pre-NDA meeting with the U.S. Food and
Drug Administration (FDA) to discuss certain matters including data
from the Phase 3 open-label extension, data from the pivotal
bioequivalence study and potential NDA submission of roluperidone
for the treatment of negative symptoms of schizophrenia.
“Following our Type C meeting with the U.S. Food and Drug
Administration (FDA) in November, 2020, during which the FDA
cautioned us that an NDA submission based on the then-current data
from the Phase 2b and Phase 3 studies would be highly unlikely to
be filed, we are moving forward with a number of important
development activities with roluperidone in support of a potential
NDA submission,” said Dr. Remy Luthringer, Executive Chairman and
Chief Executive Officer of Minerva. “The FDA has acknowledged the
promising signals observed in our Phase 2b and Phase 3 trials and
has encouraged us to continue the development of this important
agent for the treatment of negative symptoms, a critical unmet need
in the treatment of schizophrenia.
“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 Dr.
Luthringer. “We are also initiating the bioequivalence study
comparing the tablet formulations used in Phase 2b and in Phase 3
with the commercial formulation. Once we have data from both
studies in hand, we look forward to furthering our dialogue with
the FDA.”
Seltorexant
On January 19, 2021, the Company announced that Royalty Pharma
acquired the Company’s royalty interest in seltorexant for an
upfront payment of $60 million and up to $95 million in potential
future payments contingent on certain clinical, regulatory and
commercialization milestones. Seltorexant is currently in Phase 3
development for the treatment of major depressive disorder with
insomnia symptoms by Janssen Pharmaceutica, N.V. (Janssen), a
subsidiary of Johnson & Johnson.
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 million
for the fourth quarter of 2020, or loss per share of $0.17 (basic
and diluted), compared to net loss of $29.9 million for the fourth
quarter of 2019, or loss per share of $0.77 (basic and diluted).
Net income was $1.9 million for 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 million and $0.0 for the years ended December 31, 2020
and 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 million which had previously been included on
its balance sheet under deferred revenue.
- R&D Expenses:
Research and development (R&D) expenses were $3.6 million and
$28.5 million for the fourth quarters of 2020 and 2019,
respectively. R&D expenses were $22.0 million and $58.1 million
for the years ended December 31, 2020 and 2019, respectively.The
decrease in R&D expense for the fourth quarter ended December
31, 2020 was primarily due to a $19.0 million charge taken in
December 2019 for 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, 2020 was due also to approximately $11.0 million from
the completion of the Phase 2b clinical trial of MIN-117 in
December 2019 and 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 million
and $2.6 million for the years ended December 31, 2020 and 2019,
respectively.
- G&A Expenses:
General and administrative (G&A) expenses were $3.7 million and
$3.8 million for the fourth quarters of 2020 and 2019,
respectively. G&A expenses were $17.3 million and $17.7 million
for the years ended December 31, 2020 and 2019, respectively.The
decreases in G&A expenses for the fourth quarter and year ended
December 31, 2020 were 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 million
and $6.5 million for the years ended December 31, 2020 and 2019,
respectively.
- Cash Position: Cash, cash equivalents and
restricted cash as of December 31, 2020 were approximately $25.5
million, compared to $46.0 million as of December 31, 2019. In
January, 2021, the Company received a $60 million cash payment from
Royalty Pharma in connection with Royalty Pharma’s acquisition of
the Company’s royalty interest in seltorexant.
Conference Call Information:
Minerva Neurosciences will host a conference call and live audio
webcast today at 8:30 a.m. Eastern Time to discuss these results
and recent business activities. To participate, please dial (877)
312-5845 (domestic) or (765) 507-2618 (international) and refer to
conference ID 5663077.
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 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 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; 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 will advance
further in the clinical trials process and whether and when, if at
all, it 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 or
seltorexant 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 Annual
Report on Form 10-K for the year ended December 31, 2020,
filed with the Securities and Exchange Commission on March 8,
2021. 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) |
|
December 31, |
December 31, |
|
2020 |
|
|
2019 |
|
|
(in thousands) |
ASSETS |
Current Assets: |
|
|
Cash and cash equivalents |
$ |
25,357 |
|
$ |
21,413 |
|
Marketable securities |
|
- |
|
|
24,442 |
|
Restricted cash |
|
100 |
|
|
100 |
|
Prepaid expenses and other current assets |
|
1,983 |
|
|
1,182 |
|
Total current assets |
|
27,440 |
|
|
47,137 |
|
Equipment, net |
|
- |
|
|
16 |
|
Other noncurrent assets |
|
15 |
|
|
15 |
|
Operating lease right-of-use assets |
|
102 |
|
|
262 |
|
In-process research and development |
|
15,200 |
|
|
15,200 |
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
Total Assets |
$ |
57,626 |
|
$ |
77,499 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
Current Liabilities: |
|
|
Accounts payable |
$ |
996 |
|
$ |
2,317 |
|
Accrued expenses and other current liabilities |
|
2,053 |
|
|
4,139 |
|
Operating leases |
|
111 |
|
|
173 |
|
Total current liabilities |
|
3,160 |
|
|
6,629 |
|
Long-Term Liabilities: |
|
|
Deferred taxes |
|
1,803 |
|
|
1,803 |
|
Deferred revenue |
|
- |
|
|
41,176 |
|
Noncurrent operating leases |
|
- |
|
|
111 |
|
Total liabilities |
|
4,963 |
|
|
49,719 |
|
Stockholders' Equity: |
|
|
Common stock |
|
4 |
|
|
4 |
|
Additional paid-in capital |
|
337,454 |
|
|
314,512 |
|
Accumulated deficit |
|
(284,795 |
) |
|
(286,736 |
) |
Total stockholders' equity |
|
52,663 |
|
|
27,780 |
|
Total Liabilities and Stockholders' Equity |
$ |
57,626 |
|
$ |
77,499 |
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31 |
|
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
|
2020 |
|
|
2019 |
|
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
Collaborative revenue |
|
$ |
- |
|
$ |
- |
|
|
$ |
41,176 |
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
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 |
) |
Investment income |
|
|
1 |
|
|
206 |
|
|
|
161 |
|
|
1,456 |
|
(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 |
|
Contact:
William B. BoniVP, Investor Relations/Corp.
CommunicationsMinerva Neurosciences, Inc.(617) 600-7376
Minerva Neurosciences (NASDAQ:NERV)
Historical Stock Chart
From Mar 2024 to Apr 2024
Minerva Neurosciences (NASDAQ:NERV)
Historical Stock Chart
From Apr 2023 to Apr 2024