Minerva Neurosciences Reports 2023 First Quarter Financial Results and Business Updates
15 May 2023 - 9:30PM
Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage
biopharmaceutical company focused on the development of therapies
to treat central nervous system disorders, today reported business
updates and financial results for the first quarter ended March 31,
2023.
“The first quarter saw the achievement of a significant
milestone for our investigational drug, roluperidone, and for
Minerva, as the U.S. Food and Drug Administration (FDA) filed our
New Drug Application (NDA) for roluperidone for the treatment of
negative symptoms of schizophrenia on April 27, 2023. The FDA has
assigned a Prescription Drug User Fee Act (PDUFA) goal date of
February 26, 2024. We believe roluperidone has a unique
mechanism of action and is intended to treat a group of patients
that, to date, have not had an approved treatment. This is a
completely new approach to treating negative symptoms of
schizophrenia and we look forward to continuing to work with
the FDA as they undertake their review.
“Successfully treating the negative symptoms of schizophrenia
has historically been a significant challenge. If approved,
roluperidone will be the first approved treatment for negative
symptoms of schizophrenia in the U.S. We believe it has the
potential to beneficially impact patients’ quality of life, reduce
the burden on families and caregivers and provide physicians with a
new treatment option,” said Dr. Remy Luthringer, Executive
Chairman and Chief Executive Officer of Minerva.
Recent Business Highlights
- The Company submitted a Formal
Dispute Resolution Request (FDRR) on March 2, 2023, and met with
the FDA on March 28, 2023. At the meeting the Company presented a
detailed summary of data to address the issues raised in the Refuse
to File letter (RTF) received by the Company in October 2022.
- On April 27, 2023, the FDA
confirmed filing of Minerva’s NDA for roluperidone for the
treatment of negative symptoms in patients with schizophrenia.
- On May 8, 2023, the FDA confirmed
that they had assigned a PDUFA goal date of February 26, 2024.
First Quarter 2023 Financial Results
- Research and development
(R&D) expense: Research and development expenses were
$2.7 million and $5.0 million for the three months ended
March 31, 2023 and 2022, respectively, a decrease of
approximately $2.3 million. The decrease in research and
development expenses was primarily due to lower non-cash stock
compensation costs, and lower consultant and contractor fees
related to the NDA that was submitted during 2022. Non-cash stock
compensation expense included in research and development expenses
was $0.2 million and $0.5 million for the three months ended
March 31, 2023 and 2022, respectively.
- General and administrative
(G&A) expense: General and administrative expenses
were $2.7 million and $3.0 million for the three months ended
March 31, 2023 and 2022, respectively, a decrease of
approximately $0.3 million. The decrease in general and
administrative expenses was primarily due to lower non-cash stock
compensation costs and lower insurance costs. Non-cash stock
compensation expense included in general and administrative
expenses was $0.2 million and $0.6 million for the three months
ended March 31, 2023 and 2022, respectively.
- Non-cash interest
expense: For the three months ended March 31, 2023 and
2022 we recognized non-cash interest expense of $2.0 million and
$1.8 million, respectively, an increase of $0.2 million. The
increase was primarily due to an increase in the carrying value of
the liability related to the sale of future royalties for
seltorexant to Royalty Pharma, for which upfront milestone payments
are being amortized under the interest method over the estimated
life of the agreement.
- Net loss: Net loss
for the first quarter ended March 31, 2023 was $7.0 million, or a
loss per share of $1.31 (basic and diluted), as compared to a net
loss of $9.8 million for the first quarter ended March 31, 2022, or
a loss per share of $1.83 (basic and diluted).
- Cash Position:
Cash, cash equivalents, and restricted cash as of March 31, 2023
were approximately $36.1 million, compared to $36.2 million as of
December 31, 2022. In January 2023 we received a refund of our NDA
filing fee of $3.1 million from the FDA. This refund was made in
accordance with the Federal Food Drug and Cosmetic Act, which
allows a fee waiver for a small business submitting its first human
drug application.
Conference Call Information:
The live conference call will begin this morning at
8:30 a.m. ET and may be accessed here and on the
Company’s website under Events and Presentations.
The archived webcast will be available on the Company’s website
beginning approximately two hours after the event for 90 days.
About Minerva Neurosciences
Minerva Neurosciences, Inc. (Nasdaq: NERV) is a clinical-stage
biopharmaceutical company focused on developing product candidates
to treat central nervous system (CNS) diseases. Our goal is to
transform the lives of patients with improved therapeutic options.
Minerva’s portfolio of compounds includes roluperidone (MIN-101),
for negative symptoms of schizophrenia, and MIN-301, for
Parkinson’s disease. For more information, please visit our
website.
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, but are not limited to, statements herein with respect to
the regulatory progress and therapeutic potential of roluperidone
for the treatment of negative symptoms in patients with
schizophrenia. 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
the FDA will require additional trials or data which may
significantly delay and put at risk our efforts to obtain
regulatory approval; whether the FDA may meet expected review
timelines for our NDA; whether roluperidone will be successfully
marketed if approved; management’s ability to successfully achieve
its goals; our ability to raise additional capital to fund our
operations and corporate objectives on terms acceptable to us;
general economic conditions; and other factors that are described
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, 2022, filed with
the Securities and Exchange Commission on March 8, 2023, as
updated by our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2023. Copies of reports filed with the SEC are
posted on our website at http://ir.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.
Contact:
Investor inquiries:Frederick AhlholmChief
Financial OfficerMinerva Neurosciences,
Inc.info@minervaneurosciences.com
Media inquiries: Helen ShikPrincipalShik
Communications LLChelen@shikcommunications.com
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED
BALANCE SHEET DATA |
|
|
|
|
|
|
(Unaudited, in
thousands) |
|
|
|
|
|
|
|
March 31, 2023 |
December 31, 2022 |
ASSETS |
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
35,978 |
|
$ |
36,094 |
|
Restricted cash |
|
100 |
|
|
100 |
|
Refundable regulatory fee |
|
- |
|
|
3,117 |
|
Prepaid expenses and other current assets |
|
596 |
|
|
848 |
|
Total current assets |
|
36,674 |
|
|
40,159 |
|
Equipment & capitalized software, net |
|
52 |
|
|
59 |
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
Total Assets |
$ |
51,595 |
|
$ |
55,087 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' (DEFICIT)
EQUITY |
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
Accounts payable |
$ |
961 |
|
$ |
969 |
|
Accrued expenses and other current liabilities |
|
1,541 |
|
|
408 |
|
Total current liabilities |
|
2,502 |
|
|
1,377 |
|
Long-Term Liabilities: |
|
|
|
|
|
|
Liability related to the sale of future royalties |
|
75,711 |
|
|
73,734 |
|
Total liabilities |
|
78,213 |
|
|
75,111 |
|
Stockholders' (Deficit) Equity: |
|
|
|
|
|
|
Common stock |
|
1 |
|
|
1 |
|
Additional paid-in capital |
|
347,161 |
|
|
346,785 |
|
Accumulated deficit |
|
(373,780 |
) |
|
(366,810 |
) |
Total stockholders' (deficit) equity |
|
(26,618 |
) |
|
(20,024 |
) |
Total Liabilities and Stockholders' (Deficit) Equity |
$ |
51,595 |
|
$ |
55,087 |
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF
OPERATIONS(Unaudited) |
|
|
Three Months Ended December 31,(in
thousands, except per share amounts) |
|
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
$ |
2,653 |
|
$ |
4,960 |
|
General and administrative |
|
|
2,695 |
|
|
3,029 |
|
Total operating expenses |
|
|
5,348 |
|
|
7,989 |
|
Loss from operations |
|
|
(5,348 |
) |
|
(7,989 |
) |
|
|
|
|
|
|
|
|
Foreign exchange loss |
|
|
(9 |
) |
|
(4 |
) |
Investment income |
|
|
364 |
|
|
8 |
|
Non-cash interest expense for the sale of future royalties |
|
|
(1,977 |
) |
|
(1,779 |
) |
Net loss |
|
|
(6,970 |
) |
|
(9,764 |
) |
Net loss per share, basic and
diluted |
|
$ |
(1.31 |
) |
$ |
(1.83 |
) |
Weighted average
shares outstanding, basic and diluted |
|
5,340 |
|
|
5,340 |
|
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