Minerva Neurosciences Reports Third Quarter 2022 Financial Results and Business Updates
November 09 2022 - 8:00AM
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
September 30, 2022.
Roluperidone Update As announced on August 17,
2022, the company submitted to the U.S. Food and Drug
Administration (FDA) a New Drug Application (NDA) for roluperidone
to treat negative symptoms in schizophrenia. The submission
included data from two clinical trials, the company’s phase 2b and
phase 3 studies, in patients diagnosed with schizophrenia with
negative symptoms.
On October 17, 2022, the company announced that it had received
a refusal to file letter from the FDA. The company has requested a
Type A meeting and anticipates that the Type A meeting will occur
by the end of this year.
“We believe that a large subset of patients diagnosed with
schizophrenia do not require continuous treatment with
antipsychotics for positive symptoms yet still suffer negative
symptoms. We developed roluperidone as a monotherapy for this
patient sub-population. We discussed with the FDA the need for a
treatment for this specific sub-population of U.S. patients and the
FDA has acknowledged that negative symptoms represent a significant
unmet medical need for which there are currently no approved
treatments,” said Dr. Remy Luthringer, Executive Chairman and Chief
Executive Officer of Minerva Neurosciences. “While we are
disappointed that the FDA did not accept our NDA for roluperidone,
the Company looks forward to discussions with the FDA at the Type A
meeting.”
Third Quarter 2022 Financial Results
- Net
Loss: Net loss was $6.9 million for the third
quarter of 2022, or net loss per share of $1.29 basic and diluted,
as compared to net loss of $9.2 million, or net loss per share of
$1.72 basic and diluted, for the third quarter of 2021. Net loss
was $25.4 million for the nine months ended September 30, 2022, or
net loss per share of $4.75 basic and diluted, as compared to net
loss of $28.6 million, or net loss per share of $5.36 basic and
diluted for the nine months ended September 30, 2021.
- R&D
Expense: For the three months ended September 30, 2022 and
2021, research and development (R&D) expense was $2.4 million
and $4.5 million, respectively, a decrease of approximately $2.1
million. For the three months ended September 30, 2022 and 2021,
non-cash stock compensation expense included in R&D was $0.5
million in both periods.For the nine months ended September 30,
2022 and 2021, R&D expense was $11.5 million and $13.3 million,
respectively, a decrease of approximately $1.8 million. For the
nine months ended September 30, 2022 and 2021, non-cash stock
compensation expense included in R&D was $1.5 million and $1.8
million, respectively.The decrease in R&D expense for both the
three and nine-month periods ended September 30, 2022 versus the
comparable prior year periods was primarily due to lower costs for
the Phase 3 clinical trial of roluperidone due to the completion of
the 40-week open-label extension in 2021, partially offset by
higher consulting fees in support of the NDA submission in August
2022.
- G&A
Expense: For the three months ended September 30, 2022 and
2021, general and administrative (G&A) expense was $2.8 million
and $3.0 million, respectively, a decrease of approximately $0.2
million. For the three months ended September 30, 2022 and 2021,
non-cash stock compensation expense included in G&A was $0.5
million and $0.6 million, respectively.For the nine months ended
September 30, 2022 and 2021, G&A expense was $8.7 million and
$10.7 million, respectively, a decrease of approximately
$2.0 million. For the nine months ended September 30, 2022 and
September 30, 2021, non-cash stock compensation expense included in
G&A was $1.6 million and $2.2 million, respectively.The
decrease in G&A expense for both the three and nine-month
periods ended September 30, 2022 versus the comparable prior year
periods was primarily due to lower legal and insurance costs.
- Non-cash Interest Expense for the Sale of Future
Royalties: For the three months ended September 30, 2022
and 2021, non-cash interest expense for the sale of future
royalties was $1.9 million and $1.7 million, respectively, an
increase of approximately $0.2 million. For the nine months ended
September 30, 2022 and 2021, non-cash interest expense for the sale
of future royalties was $5.5 million and $4.6 million,
respectively, an increase of approximately $0.9 million. The
increase in non-cash interest expense for both the three and nine
months ended September 30, 2022 versus the prior year periods was
primarily due to interest accruing with effect from January 19,
2021, the date at which the Company entered into an agreement to
sell our royalty interest in seltorexant to Royalty Pharma, as well
as an increase in the underlying balance of the liability, which
totaled $71.8 million at September 30, 2022. The effective interest
rate is based upon estimates which contain significant assumptions
regarding the timing and amount of expected royalty and milestone
payments to be recognized over the royalty period.
- Cash
Position: Cash, cash equivalents and restricted cash as of
September 30, 2022 were approximately $40.3 million, compared to
$60.9 million as of December 31, 2021. In September 2022, the
Company entered into an Open Market Sale Agreement with Jefferies
LLC pursuant to which the Company may offer and sell shares of its
common stock, by any method permitted by law deemed to be an
“at-the-market” offering as defined in Rule 415 promulgated under
the Securities Act of 1933, as amended. During the nine months
ended September 30, 2022, no shares of the Company’s common stock
were issued or sold under the agreement. As of September 30, 2022,
an aggregate of $22.6 million was eligible for sale under the
Company’s effective registration statement on Form S-3 (File No.
333-267424). The Company expects that its existing cash and cash
equivalents will be sufficient to meet its anticipated capital
requirements for at least the next 12 months based on its current
operating plan. The assumptions upon which this estimate is based
are routinely evaluated and may be subject to change.
Conference Call Information:
The live webcast 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),
in clinical development 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. These statements may be
identified by words such as “aims,” “anticipates,” “believes,”
“could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,”
“may,” “plans,” “possible,” “potential,” “seeks,” “will” and
variations of these words or similar expressions that are intended
to identify forward-looking statements, although not all
forward-looking statements contain these words. Forward-looking
statements in this press release include, but are not limited to,
statements with respect to the clinical development of roluperidone
as monotherapy for the treatment of negative symptoms of
schizophrenia; the timing and outcomes of future interactions with
the FDA; patient prevalence; and our cash runway. 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 a Type A meeting
will be granted and whether our future interactions with the FDA
will have satisfactory outcomes; 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. Other factors that may cause our
actual results to differ from those expressed or implied in the
forward-looking statements in this press release are identified
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 September 30, 2022, filed with
the Securities and Exchange Commission on November 9, 2022.
Copies of reports filed with the SEC are posted on our
website: 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 expressly disclaim any
obligation to update any forward-looking statements, except as
required by law.
For more information: Investor inquiries:
Fred
Ahlholm CFO,
Minerva Neurosciences
info@minervaneurosciences.com
Media inquiries:
Helen Shik Principal, Shik Communications LLC
helen@ShikCommunications.com
CONDENSED CONSOLIDATED BALANCE SHEET DATA |
(Unaudited) |
|
September 30, 2022 |
December 31, 2021 |
|
(in thousands) |
ASSETS |
Current Assets: |
|
|
Cash and cash equivalents |
$ |
40,220 |
|
$ |
60,755 |
|
Restricted cash |
|
100 |
|
|
100 |
|
Refundable regulatory fee |
|
3,117 |
|
|
- |
|
Prepaid expenses and other current assets |
|
1,404 |
|
|
1,346 |
|
Total current assets |
|
44,841 |
|
|
62,201 |
|
Capitalized software, net |
|
49 |
|
|
52 |
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
Total Assets |
$ |
59,759 |
|
$ |
77,122 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' (DEFICIT)
EQUITY |
Current Liabilities: |
|
|
Accounts payable |
$ |
533 |
|
$ |
1,853 |
|
Accrued expenses and other current liabilities |
|
1,664 |
|
|
966 |
|
Total current liabilities |
|
2,197 |
|
|
2,819 |
|
Long-Term Liabilities: |
|
|
Liability related to the sale of future royalties |
|
71,808 |
|
|
66,327 |
|
Total liabilities |
|
74,005 |
|
|
69,146 |
|
Stockholders' (Deficit) Equity: |
|
|
Common stock |
|
1 |
|
|
1 |
|
Additional paid-in capital |
|
345,837 |
|
|
342,676 |
|
Accumulated deficit |
|
(360,084 |
) |
|
(334,701 |
) |
Total stockholders' (deficit) equity |
|
(14,246 |
) |
|
7,976 |
|
Total Liabilities and Stockholders' (Deficit) Equity |
$ |
59,759 |
|
$ |
77,122 |
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
(Unaudited) |
|
|
|
|
|
|
|
|
Three Months Ended September 30,(in
thousands, except per share amounts) |
|
Nine Months Ended September 30(in
thousands, except per share amounts) |
|
|
|
2022 |
|
|
2021 |
|
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
2,367 |
|
$ |
4,513 |
|
|
$ |
11,459 |
|
$ |
13,292 |
|
General and
administrative |
|
|
2,840 |
|
|
3,005 |
|
|
|
8,703 |
|
|
10,696 |
|
Total operating expenses |
|
|
5,207 |
|
|
7,518 |
|
|
|
20,162 |
|
|
23,988 |
|
Loss from operations |
|
|
(5,207 |
) |
|
(7,518 |
) |
|
|
(20,162 |
) |
|
(23,988 |
) |
|
|
|
|
|
|
|
Foreign exchange gains
(losses) |
|
|
2 |
|
|
(5 |
) |
|
|
- |
|
|
(29 |
) |
Investment income |
|
|
180 |
|
|
4 |
|
|
|
260 |
|
|
13 |
|
Non-cash interest expense for
the sale of future royalties |
|
|
(1,875 |
) |
|
(1,686 |
) |
|
|
(5,481 |
) |
|
(4,595 |
) |
Net loss |
|
$ |
(6,900 |
) |
$ |
(9,205 |
) |
|
$ |
(25,383 |
) |
$ |
(28,599 |
) |
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(1.29 |
) |
$ |
(1.72 |
) |
|
$ |
(4.75 |
) |
$ |
(5.36 |
) |
Weighted average shares
outstanding, basic and diluted |
|
|
5,340 |
|
|
5,340 |
|
|
|
5,340 |
|
|
5,340 |
|
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