Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company
utilizing its proprietary Precision Timed Release™ (PTR™) drug
delivery platform technology to build and advance a pipeline of
next-generation pharmaceutical products, today announced its
financial results for the three months ended March 31, 2024, and
provided a clinical and business update.
“As Cingulate continues to meet with potential partners for the
licensing of CTx-1301, we expect to complete all remaining
requirements for the filing of an NDA in the first half of 2025,”
said Cingulate Chairman and CEO Shane J. Schaffer. “We are pleased
with our ability to support our business operations, including the
advancement of CTx-1301, through our capital raising efforts during
the first quarter.”
$10.7 Million of Capital Raised and $3.3 Million of Debt
Converted to Equity in
2024
Since January 1, 2024, the Company sold shares of common stock
under its At the Market Offering Agreement with H.C. Wainwright
& Co., LLC for gross proceeds of $3.2 million. In February
2024, the Company closed a $7.5 million public offering of its
common stock (or pre-funded warrants in lieu thereof) and Series A
and Series B warrants to purchase shares of common stock, at a
public offering price of $2.00 per share (or common stock
equivalent in lieu thereof) and accompanying warrants.
Additionally, in January 2024, Werth Family Investment Associates,
LLC , the manager of which is Peter J. Werth, a member of the
Cingulate board of directors, converted at a 10 percent premium to
market the remaining $3.3 million of outstanding debt plus accrued
interest into pre-funded warrants to purchase shares of common
stock.
First Quarter ResultsCash
Position: As of March 31, 2024, Cingulate had $1.1 million
in cash and cash equivalents. Management intends to seek
opportunities to access additional capital as needed.
Liabilities: As of March 31, 2024, total
liabilities were $2.3 million, a decrease from December 31, 2023 of
$8.1 million, including the conversion of the related party note
payable in the amount of $3.3 million.
Stockholders’ Equity: As of March 31, 2024,
total stockholders’ equity was $3.2 million, an increase of $10
million from the end of 2023.
R&D Expenses: R&D expenses were $1.8
million for the three months ended March 31, 2024, a decrease of
$0.3 million from the three months ended March 31, 2023. This
change was primarily the result of increased clinical activity in
the three months ended March 31, 2024 as compared to the same
period in 2023, offset by decreased manufacturing activity and
personnel expenses in the three months ended March 31, 2024 as
compared to the same period in 2023. During the first quarter of
2024, we incurred significant costs relating to two Phase 3 studies
for CTx-1301, the fixed dose pediatric and adolescent safety and
efficacy study and the pediatric dose optimization and duration
study. In the first quarter of 2023, we incurred costs for the
manufacturing of clinical supply for these two studies. The
decrease in personnel costs is the result of lower headcount and
the cost containment measures, which we implemented in late 2023 in
order to conserve cash, which included salary reductions ranging
from 5-55% for all employees.
G&A Expenses: Total G&A expenses were
$1.1 million for the three months ended March 31, 2024, a decrease
of $0.6 million from the three months ended March 31, 2023. This
change is primarily the result of a decrease in personnel expenses
and insurance expense. The decrease in personnel expenses is the
result of lower headcount and the cost containment measures
discussed above, which we implemented in late 2023. In addition,
there was a decrease in the annual directors’ and officers’
insurance premium from 2023 to 2024.
Net Loss: Net loss was $3.0
million for the three months ended March 31, 2024, compared to $4.0
million for the same period in 2023. The decrease in the net loss
primarily relates to a decrease in R&D and G&A expenses
described above.
Cingulate
Inc. |
Consolidated
Balance Sheet Data |
|
|
|
March
31, |
|
December
31, |
|
|
|
2024 |
|
|
|
2023 |
|
Cash, cash equivalents and short-term investments |
|
$ |
1,113,830 |
|
|
$ |
52,416 |
|
Total assets |
|
$ |
5,494,515 |
|
|
$ |
3,491,436 |
|
Total liabilities |
|
$ |
2,278,396 |
|
|
$ |
10,360,865 |
|
Accumulated deficit |
|
$ |
(95,915,920 |
) |
|
$ |
(92,943,443 |
) |
Total stockholders' equity |
|
$ |
3,216,119 |
|
|
$ |
(6,869,429 |
) |
|
|
|
|
|
|
|
|
|
Cingulate
Inc. |
Consolidated
Statements of Operations |
|
|
|
|
|
Three Months
Ended March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
Operating
expenses: |
|
|
|
|
Research and development |
|
$ |
1,806,985 |
|
|
$ |
2,128,616 |
|
General and administrative |
|
|
1,141,232 |
|
|
|
1,721,379 |
|
Operating loss |
|
|
(2,948,217 |
) |
|
|
(3,849,995 |
) |
|
|
|
|
|
Interest and other income (expense), net |
|
|
(24,260 |
) |
|
|
(154,892 |
) |
Loss before
income taxes |
|
|
(2,972,477 |
) |
|
|
(4,004,887 |
) |
Income tax
benefit (expense) |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Net
loss |
|
|
(2,972,477 |
) |
|
|
(4,004,887 |
) |
Net loss per
share of common stock, basic and diluted |
|
$ |
(0.60 |
) |
|
$ |
(7.08 |
) |
|
|
|
|
|
About Cingulate®Cingulate Inc. is a
biopharmaceutical company utilizing its proprietary Precision Timed
Release™ (PTR™) drug delivery platform technology to build and
advance a pipeline of next-generation pharmaceutical products,
designed to improve the lives of patients suffering from frequently
diagnosed conditions characterized by burdensome daily dosing
regimens and suboptimal treatment outcomes. With an initial focus
on the treatment of Attention Deficit/Hyperactivity Disorder
(ADHD), Cingulate is identifying and evaluating additional
therapeutic areas where its PTR technology may be employed to
develop future product candidates, such as anxiety disorders.
Cingulate is headquartered in Kansas City, KS. For more
information visit Cingulate.com.
Forward-Looking Statements This press
release contains “forward-looking statements” within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended. These
forward-looking statements include all statements, other than
statements of historical fact, regarding our current views and
assumptions with respect to future events regarding our business,
including statements with respect to our plans, assumptions,
expectations, beliefs and objectives with respect to product
development, clinical studies, clinical and regulatory timelines,
market opportunity, competitive position, business strategies,
potential growth opportunities and other statements that are
predictive in nature. These statements are generally identified by
the use of such words as “may,” “could,” “should,” “would,”
“believe,” “anticipate,” “forecast,” “estimate,” “expect,”
“intend,” “plan,” “continue,” “outlook,” “will,” “potential” and
similar statements of a future or forward-looking nature. Readers
are cautioned that any forward-looking information provided by us
or on our behalf is not a guarantee of future performance. Actual
results may differ materially from those contained in these
forward-looking statements as a result of various factors disclosed
in our filings with the Securities and Exchange Commission (SEC),
including the “Risk Factors” section of our Annual Report on Form
10-K filed with the SEC on April 1, 2024. All forward-looking
statements speak only as of the date on which they are made, and we
undertake no duty to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except to the extent required by law.
Investor & Public Relations:Thomas
DaltonVice President, Investor & Public Relations,
Cingulatetdalton@cingulate.com(913) 942-2301Matt
KrepsDarrow Associatesmkreps@darrowir.com(214)
597-8200
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