Minerva Neurosciences Reports Fiscal Year 2022 Fourth Quarter And Year End Financial Results And Business Updates
08 Marzo 2023 - 6:30AM
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 fourth quarter and year ended
December 31, 2022.
Corporate Update
“In 2022, we had multiple interactions with the FDA regarding
the regulatory path forward for our lead compound, roluperidone.
After submitting an NDA for roluperidone to the FDA in August, we
received a Refuse to File letter (RTF) in the fall, which was
upheld following another meeting with the FDA. We remain committed
to developing roluperidone as a potentially transformative
treatment for those patients with negative symptoms of
schizophrenia and we anticipate further discussion with the FDA
over the coming months,” said Dr. Remy Luthringer, Executive
Chairman and Chief Executive Officer of Minerva.
Roluperidone
- In March 2022, Minerva attended a Type C meeting with the FDA,
who advised that certain concerns remained, which were outlined in
our press release on April 7, 2022, specifically:
- The applicability of the Phase 2b data (conducted outside of
the U.S). to the U.S. population;
- The Phase 3 study did not meet its primary endpoint;
- FDA sought reassurance that Minerva could reliably identify
patients who do not need antipsychotics and how to evaluate the
stability of those patients; and
- The FDA also noted that roluperidone might be used by
prescribers in a way that differs significantly from the intended
monotherapy use and that the sponsor had not presented data to show
that roluperidone would not interfere with the safety or efficacy
of antipsychotic medications.
- In August 2022,
the Company submitted the NDA for roluperidone. Additional data
were provided which the Company believed addressed the concerns
raised by FDA at the April 2022 Type C meeting. The submission was
supported by results from two late-stage, well-controlled studies
in patients with moderate to severe negative symptoms and stable
positive symptoms of schizophrenia.
- In October 2022,
Minerva received a RTF from the FDA. Consequently, a Type A meeting
was requested to discuss the RTF, which was held on November 30,
2022. Following the Type A meeting, the FDA confirmed that the RTF
remains in effect.
Fourth Quarter and Year End Financial
Results
- Net loss: Net loss
for the fourth quarter ended December 31, 2022 was $6.7 million, or
a loss per share of $1.26 (basic and diluted), as compared to a net
loss of $21.3 million for the fourth quarter ended December 31
2021, or a loss per share of $3.99 (basic and diluted). For the
year ended December 31, 2022, net loss was $32.1 million, or a loss
per share of $6.01 (basic and diluted), versus a net loss of $49.9
million for the year ended December 31, 2021, or a loss per share
of $9.35 (basic and diluted).
- Research and development
(R&D) expense: R&D expense for the fourth quarters
ended December 31, 2022 and 2021 was $3.2 million and $18.7
million, respectively, a decrease of $15.5 million. The decrease in
R&D expense was primarily due to an impairment charge of $15.2
million in the fourth quarter of 2021 to the carrying value of
in-process research and development related to the MIN-301
development program.R&D expense for the years ended December
31, 2022 and 2021 was $14.6 million and $32.0 million,
respectively, a decrease of $17.4 million. The decrease
in R&D expense was primarily due to an impairment charge of
$15.2 million in the fourth quarter of 2021 to the carrying value
of in-process research and development related to MIN-301, as well
as lower clinical trial costs during 2022. Non-cash stock
compensation costs included within R&D expense for the years
ended December 31, 2022 and 2021 was $2.0 million and $2.4 million,
respectively.
- General and administrative
(G&A) expense: G&A expense for the fourth quarters
ended December 31, 2022 and 2021 was $1.9 million and $2.6 million,
respectively, a decrease of $0.7 million. G&A expense for the
years ended December 31, 2022 and 2021 was $10.6 million and $13.3
million, respectively, a decrease of $2.7 million. The decrease in
G&A expense for both the fourth quarter and year ended December
31, 2022 versus the prior year periods was primarily due to lower
compensation expense and lower legal and insurance fees. Non-cash
stock compensation costs included in G&A expense for the years
ended December 31, 2022 and 2021 was $2.1 million and $2.8 million,
respectively.
- Cash Position:
Cash, cash equivalents, and restricted cash as of December 31, 2022
were approximately $36.2 million, compared to $60.9 million as of
December 31, 2021. 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 clinical and therapeutic potential of roluperidone (MIN-101);
and the expectations regarding continued conversation with the FDA
with respect to roluperidone and the timing thereof. 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 FDA or
equivalent foreign regulatory agencies and for which indications;
whether we will be able to continue the discussion with the FDA
regarding our NDA submission for roluperidone and the outcome
thereof; 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. 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.
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 |
|
(in
thousands) |
|
|
December 31, 2022 |
December 31, 2021 |
ASSETS |
Current Assets: |
|
|
Cash and cash equivalents |
$ |
36,094 |
|
$ |
60,755 |
|
Restricted cash |
|
100 |
|
|
100 |
|
Refundable regulatory fee |
|
3,117 |
|
|
- |
|
Prepaid expenses and other current assets |
|
848 |
|
|
1,346 |
|
Total current assets |
|
40,159 |
|
|
62,201 |
|
Equipment & capitalized software, net |
|
59 |
|
|
52 |
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
Total Assets |
$ |
55,087 |
|
$ |
77,122 |
|
LIABILITIES AND STOCKHOLDERS' (DEFICIT)
EQUITY |
Current Liabilities: |
|
|
Accounts payable |
$ |
969 |
|
$ |
1,853 |
|
Accrued expenses and other current liabilities |
|
408 |
|
|
966 |
|
Total current liabilities |
|
1,377 |
|
|
2,819 |
|
Long-Term Liabilities: |
|
|
Liability related to the sale of future royalties |
|
73,734 |
|
|
66,327 |
|
Total liabilities |
|
75,111 |
|
|
69,146 |
|
Stockholders' (Deficit) Equity: |
|
|
Common stock |
|
1 |
|
|
1 |
|
Additional paid-in capital |
|
346,785 |
|
|
342,676 |
|
Accumulated deficit |
|
(366,810 |
) |
|
(334,701 |
) |
Total stockholders' (deficit) equity |
|
(20,024 |
) |
|
7,976 |
|
Total Liabilities and Stockholders' (Deficit) Equity |
$ |
55,087 |
|
$ |
77,122 |
|
|
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
|
|
|
Three Months Ended December 31,(in
thousands, except per share amounts) |
|
Twelve Months Ended December 31(in
thousands, except per share amounts) |
|
|
|
2022 |
|
|
2021 |
|
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
3,190 |
|
$ |
18,746 |
|
|
$ |
14,649 |
|
$ |
32,039 |
|
General and administrative |
|
|
1,880 |
|
|
2,631 |
|
|
|
10,582 |
|
|
13,327 |
|
Total operating expenses |
|
|
5,070 |
|
|
21,377 |
|
|
|
25,231 |
|
|
45,366 |
|
Loss from operations |
|
|
(5,070 |
) |
|
(21,377 |
) |
|
|
(25,231 |
) |
|
(45,366 |
) |
|
|
|
|
|
|
|
Foreign exchange loss |
|
|
(28 |
) |
|
(4 |
) |
|
|
(28 |
) |
|
(33 |
) |
Investment income |
|
|
297 |
|
|
4 |
|
|
|
557 |
|
|
17 |
|
Non-cash interest expense for the sale of future royalties |
|
|
(1,925 |
) |
|
(1,733 |
) |
|
|
(7,407 |
) |
|
(6,327 |
) |
Loss before income taxes |
|
|
(6,726 |
) |
|
(23,110 |
) |
|
|
(32,109 |
) |
|
(51,709 |
) |
Benefit for income taxes |
|
|
- |
|
|
1,803 |
|
|
|
- |
|
|
1,803 |
|
Net loss |
|
|
(6,726 |
) |
|
(21,307 |
) |
|
|
(32,109 |
) |
|
(49,906 |
) |
Net loss per share, basic and
diluted |
|
$ |
(1.26 |
) |
$ |
(3.99 |
) |
|
$ |
(6.01 |
) |
$ |
(9.35 |
) |
Weighted average
shares outstanding, basic and diluted |
|
5,340 |
|
|
5,340 |
|
|
|
5,340 |
|
|
5,340 |
|
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