Minerva Neurosciences Reports Second Quarter 2024 Financial Results and Business Updates
06 August 2024 - 9:30PM
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
business updates and financial results for the second quarter of
2024 ending June 30, 2024.
Roluperidone NDA Update
During the first quarter of this year, the Company announced
that the U.S. Food and Drug Administration (FDA) issued a Complete
Response Letter (CRL) to its New Drug Application (NDA) for
roluperidone (f/k/a MIN-101) for the treatment of negative symptoms
in patients with schizophrenia. Since receiving the CRL, the
Company has continued to have interactions with the
FDA with the goal of addressing questions raised in the
CRL.
Second Quarter 2024 Financial Results
Research and development (R&D) expense: For
the three months ended June 30, 2024 and 2023, R&D expense was
$3.9 million and $1.9 million, respectively. R&D expense was
higher versus the prior year period primarily due to higher
subcontractor fees related to costs associated with our drug
substance validation campaign, partially offset by lower
compensation expenses. For the six months ended June 30, 2024 and
2023, R&D expense was $8.0 million and $4.5 million,
respectively. R&D expense was higher versus the prior year
period primarily due to costs associated with our drug substance
validation campaign and the conduct of the MIN-101C18 study.
General and administrative (G&A) expense:
For the three months ended June 30, 2024 and 2023, G&A expense
was $2.4 million and $2.6 million, respectively. G&A expense
was lower versus the prior year period primarily due to lower
compensation expenses. For the six months ended June 30, 2024 and
2023, G&A expense was $4.9 million and $5.3 million,
respectively. G&A expense was lower versus the prior year
period primarily due to lower compensation expenses and
professional service fees.
Non-cash interest expense: For the three and
six months ended June 30, 2024, non-cash interest expense for the
sale of future royalties was $2.3 million and $4.6 million,
respectively, as compared to $2.0 million and $4.0 million for the
three and six months ended June 30, 2023, respectively. The
increase versus the prior year period was primarily due to the
amortization of non-cash interest expense for the difference
between the balance of the liability related to the sale of future
royalties and the estimated amount of future royalties to be
received over the royalty period.
Net loss: Net loss for the three and six months
ended June 30, 2024 was $8.2 million and $16.8 million, or a basic
and diluted net loss per share of $1.09 and $2.22, respectively, as
compared to a net loss for the three and six months ended June 30,
2023 of $6.2 million and $13.2 million or a basic and diluted net
loss per share of $1.12 and $2.43, respectively.
Cash Position: Cash, cash equivalents and
restricted cash at June 30, 2024 were approximately $31.0 million,
as compared to $41.0 million at December 31, 2023.
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage
biopharmaceutical company focused on developing product candidates
to treat CNS diseases. Minerva’s goal is to transform the lives of
patients with improved therapeutic options, including roluperidone
for negative symptoms of schizophrenia and MIN-301 for Parkinson’s
disease. For more information, please visit the Company’s
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
expectations concerning Minerva’s ability to remediate or otherwise
resolve issues and deficiencies identified in the CRL and the
timing and outcome of its interactions with the FDA. 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, Minerva’s ability to address
FDA’s feedback and timing thereof; uncertainties associated with
regulatory processes, including the content and timing of decisions
by the FDA; general risks associated with developing
biopharmaceutical product candidates; management’s ability to
successfully achieve its goals; our ability to raise additional
capital to fund its operations and corporate objectives on terms
acceptable to Minerva; general economic conditions; and other
factors that are described under the caption “Risk Factors” in
Minerva’s filings with the Securities and Exchange Commission,
including its Annual Report on Form 10-K for the year
ended December 31, 2023, filed with the Securities and
Exchange Commission on February 22, 2024, as updated by its
Quarterly Report on Form 10-Q for the quarter ended June 30, 3024.
Copies of reports filed with the SEC are posted on
Minerva’s website at http://ir.minervaneurosciences.com/. The
forward-looking statements in this press release are based on
information available to the Company as of the date hereof, and the
Company disclaims 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) |
|
June 30, 2024 |
December 31, 2023 |
|
(in thousands) |
ASSETS |
Current assets: |
|
|
Cash and cash equivalents |
$ |
30,881 |
|
|
$ |
40,913 |
|
Restricted cash |
|
100 |
|
|
|
100 |
|
Prepaid expenses and other current assets |
|
428 |
|
|
|
989 |
|
Total current assets |
|
31,409 |
|
|
|
42,002 |
|
Equipment and capitalized software, net |
|
13 |
|
|
|
29 |
|
Goodwill |
|
14,869 |
|
|
|
14,869 |
|
Total assets |
$ |
46,291 |
|
|
$ |
56,900 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' DEFICIT |
Current liabilities: |
|
|
Accounts payable |
$ |
829 |
|
|
$ |
1,805 |
|
Accrued expenses and other current liabilities |
|
3,375 |
|
|
|
1,535 |
|
Total current liabilities |
|
4,204 |
|
|
|
3,340 |
|
Long-term liabilities: |
|
|
Liability related to the sale of future royalties |
|
86,579 |
|
|
|
82,017 |
|
Total liabilities |
|
90,783 |
|
|
|
85,357 |
|
Stockholders' deficit: |
|
|
Common stock |
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
369,125 |
|
|
|
368,357 |
|
Accumulated deficit |
|
(413,618 |
) |
|
|
(396,815 |
) |
Total stockholders' deficit |
|
(44,492 |
) |
|
|
(28,457 |
) |
Total liabilities and stockholders' deficit |
$ |
46,291 |
|
|
$ |
56,900 |
|
|
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
(Unaudited) |
|
|
|
|
|
|
|
|
Three Months Ended June 30,(in thousands,
except per share amounts) |
|
Six Months Ended June 30,(in thousands,
except per share amounts) |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
3,860 |
|
|
$ |
1,887 |
|
|
$ |
8,028 |
|
|
$ |
4,541 |
|
General and administrative |
|
|
2,417 |
|
|
|
2,633 |
|
|
|
4,932 |
|
|
|
5,327 |
|
Total operating expenses |
|
|
6,277 |
|
|
|
4,520 |
|
|
|
12,960 |
|
|
|
9,868 |
|
Loss from operations |
|
|
(6,277 |
) |
|
|
(4,520 |
) |
|
|
(12,960 |
) |
|
|
(9,868 |
) |
|
|
|
|
|
|
|
Foreign exchange (losses) gains |
|
|
(5 |
) |
|
|
(7 |
) |
|
|
1 |
|
|
|
(16 |
) |
Investment income |
|
|
361 |
|
|
|
365 |
|
|
|
719 |
|
|
|
730 |
|
Non-cash interest expense for the sale of future royalties |
|
|
(2,312 |
) |
|
|
(2,030 |
) |
|
|
(4,562 |
) |
|
|
(4,008 |
) |
Net loss |
|
$ |
(8,233 |
) |
|
$ |
(6,192 |
) |
|
$ |
(16,802 |
) |
|
$ |
(13,162 |
) |
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(1.09 |
) |
|
$ |
(1.12 |
) |
|
$ |
(2.22 |
) |
|
$ |
(2.43 |
) |
Weighted average shares
outstanding, basic and diluted |
|
|
7,569 |
|
|
|
5,511 |
|
|
|
7,569 |
|
|
|
5,426 |
|
|
|
|
|
|
|
|
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