Cingulate Inc. (NASDAQ: CING), a clinical-stage 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 and 12 months ended December 31,
2021, and provided a clinical and business update.
“Our recent initial public offering was a
significant milestone for Cingulate in advancing our mission to
help Attention Deficit/Hyperactivity Disorder (ADHD) patients
overcome their significant unmet needs in using currently available
treatment options,” said Shane J. Schaffer, PharmD, Chairman and
Chief Executive Officer of Cingulate. “We look forward to
initiating our pivotal Phase 3 study for CTx-1301 in the second
quarter of 2022 and beginning to dose patients as we progress
toward our goal of filing a New Drug Application (NDA) with the
U.S. Food and Drug Administration (FDA) in the second half of
2023.”
Matthew Brams, M.D., Chief Medical Officer,
added, “As a practicing psychiatrist for over 30 years, I’m proud
to be a part of the Cingulate team in realizing our vision to
provide patients and providers with a true once-daily medication to
overcome the long-standing unmet needs in ADHD. Our clinical plan
will further demonstrate our products’ ability to achieve a fast
onset of action and provide entire active-day efficacy without the
need for booster or recovery doses.”
Clinical and Business Update
CTx-1301: Cingulate has updated
its clinical program for CTx-1301 (dexmethylphenidate), its lead
investigational asset for the treatment of ADHD, based on FDA
feedback regarding the Company’s CTx-1301 initial Pediatric Study
Plan (iPSP), and longstanding guidance on the accelerated approval
pathway under Section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act.
Cingulate plans to commence two CTx-1301 Phase 3
clinical studies in 2022: (1) a fixed-dose pediatric and adolescent
safety and efficacy study, which will enroll its first patient in
the second quarter of 2022; and (2) a pediatric safety and efficacy
dose-optimization study to assess the onset and duration of
efficacy, which is targeted to begin in the second half of 2022.
Cingulate’s clinical plan will also investigate several exploratory
elements critical to ADHD patients, providers, payers, and the
larger medical community, such as the use of booster/recovery
doses, the abuse and diversion associated with short-acting
medications, and the crash/rebound effects of early medication wear
off. Results from the fixed dose study are expected in late 2022.
The entire Phase 3 clinical program is expected to include
approximately 350 patients. Assuming Cingulate receives positive
clinical results from its Phase 3 trials, the Company plans to
submit an NDA for CTx-1301 in the second half of 2023 under the
Section 505(b)(2) pathway.
Cingulate believes the updated clinical program
for CTx-1301 accelerates the study timeline by condensing the
number and design of studies, therefore potentially reducing the
time and expense to submission of the NDA for CTx-1301 to the FDA
for potential approval.
In order to achieve an expected second half 2023
NDA submission for potential FDA approval, the Company believes it
will need approximately $15 million of additional capital and is
evaluating alternatives to raise additional capital, including
equity and debt financing and non-dilutive strategic collaborations
in the U.S. and abroad. A commercial collaboration or strategic
relationship with an established pharmaceutical company, which is a
key Company initiative, would provide more immediate access to
marketing, sales, market access and distribution
infrastructure.
CTx-1302: Cingulate plans to
initiate a Phase 1/2 bioavailability study in ADHD patients for
CTx-1302 (dextroamphetamine), its second investigational asset for
the treatment of ADHD, in 2023 and, if the results from this study
are successful, the Company plans to initiate pivotal Phase 3
clinical trials in all patient segments for CTx-1302 in late 2023
with results expected in late 2024.
CTx-2103: Cingulate has
embarked on a program to develop CTx-2103 (buspirone), which would
expand the PTR platform within the anxiety therapeutic category.
The Company plans to initiate a clinical trial for CTx-2103 in the
first half of 2022.
Fourth Quarter and Full Year Results
Cash Position: As of December
31, 2021, Cingulate had $16.5 million in cash and cash equivalents,
as compared to $1.2 million in cash and cash equivalents as of
December 31, 2020. Cash and cash equivalents as of December 31,
2021 reflect the net proceeds of our IPO of approximately $20.4
million, which closed on December 10, 2021. Based on the Company’s
current operating plan, Cingulate expects its cash and cash
equivalents as of December 31, 2021 will enable the Company to fund
its research and development and general and administrative
expenditures through late 2022.
R&D Expenses: Research and
development expenses were $1.3 million for the three months ended
December 31, 2021, compared to $0.6 million for the same period in
2020. Research and development expenses were $8.4 million for the
year ended December 31, 2021, compared to $5.1 million for the year
ended December 31, 2020. The increase in the three-month period was
primarily related to costs incurred in late 2021 in preparation of
the manufacturing of Phase 3 clinical supply of CTx-1301. The
increase from 2020 to 2021 was related to the recognition of $4.6
million of R&D expense for a one-time, noncash compensation
charge in the third quarter of 2021 due to the exchange of Profits
Interest Units (PIUs) in Cingulate Therapeutics LLC for common
stock of Cingulate Inc. prior to the IPO, which was based on the
fair value of the common stock at the time of the exchange,
partially offset by a decrease in clinical operations expense of
$1.2 million due to a decrease in clinical activity. In early 2020,
the Company incurred significant clinical costs relating to the
completion of the Phase 1/2 comparative bioavailability study for
CTx-1301. During 2021, clinical activity primarily consisted of
study startup costs for the fixed dose Phase 3 study for
CTx-1301.
G&A Expenses: General and
administrative expenses were $1.4 million for the three months
ended December 31, 2021, compared to $0.5 million for the same
period in 2020. General and administrative expenses were $12.3
million for the year ended December 31, 2021, compared to $2.0
million for the year ended December 31, 2020. The increase in the
three-month period was primarily due to an increase in personnel
costs relating to annual compensation increases and the addition of
personnel in late 2021, as well as an increase in directors’ and
officers’ insurance costs and professional fees related to legal
and investor relations, as the Company was preparing to operate as
a public company. The increase from 2020 to 2021 was primarily
related to the recognition of $8.1 million of G&A personnel
expenses for a one-time, noncash compensation charge in the third
quarter of 2021 due to the exchange of Profits Interest Units
(PIUs) in Cingulate Therapeutics LLC for common stock of Cingulate
Inc. described above. In addition, the increase was due to an
increase in personnel costs relating to annual compensation
increases and the addition of personnel in late 2021, as well as an
increase in directors’ and officers’ insurance costs and
professional fees related to legal, consulting, audit and investor
relations, as the Company was preparing to operate as a public
company.
Net Loss: Net loss was $2.7
million for the three months ended December 31, 2021, compared to
$1.2 million for the same period in 2020. Net loss was $20.7
million for the year ended December 31, 2021, compared to $7.2
million for the year ended December 31, 2020. The increase in the
net loss from 2020 to 2021 primarily relates to a one-time, noncash
compensation charge of $12.7 million in the third quarter of 2021
due to the exchange of PIUs in Cingulate Therapeutics LLC for
common stock of Cingulate Inc. described above.
About Cingulate®
Cingulate Inc. is a clinical-stage
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. 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 prospectus filed with the SEC on December
9, 2021. 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.
Cingulate
Inc.Consolidated Balance Sheet Data
|
|
As of December 31, |
|
|
|
2021 |
|
|
2020 |
|
Cash, cash equivalents and
short-term investments |
|
$ |
16,493,678 |
|
|
$ |
1,198,605 |
|
Total current assets |
|
|
18,882,279 |
|
|
|
1,789,873 |
|
Total assets |
|
|
22,886,257 |
|
|
|
5,787,556 |
|
Total liabilities |
|
|
2,042,715 |
|
|
|
4,495,121 |
|
Accumulated deficit |
|
|
(51,732,264 |
) |
|
|
(31,022,106 |
) |
Total stockholders'
equity |
|
|
20,843,542 |
|
|
|
1,292,435 |
|
Cingulate
Inc.Consolidated Statements of
Operations
|
|
Three Months Ended December 31, |
|
|
Year Ended December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,262,976 |
|
|
$ |
629,866 |
|
|
$ |
8,410,489 |
|
|
$ |
5,093,277 |
|
General and administrative |
|
|
1,384,150 |
|
|
|
523,153 |
|
|
|
12,268,909 |
|
|
|
1,990,086 |
|
Operating
loss |
|
|
(2,647,126 |
) |
|
|
(1,153,019 |
) |
|
|
(20,679,398 |
) |
|
|
(7,083,363 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income (expense), net |
|
|
(6,599 |
) |
|
|
(40,606 |
) |
|
|
(30,593 |
) |
|
|
(100,252 |
) |
Loss before income taxes |
|
|
(2,653,725 |
) |
|
|
(1,193,625 |
) |
|
|
(20,709,991 |
) |
|
|
(7,183,615 |
) |
Income tax benefit
(expense) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,653,725 |
) |
|
$ |
(1,193,625 |
) |
|
$ |
(20,709,991 |
) |
|
$ |
(7,183,615 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.32 |
) |
|
$ |
n/a |
|
|
$ |
(2.79 |
) |
|
$ |
n/a |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares used in computing net loss per share of common stock, basic
and diluted |
|
|
8,229,702 |
|
|
|
n/a |
|
|
|
7,413,579 |
|
|
|
n/a |
|
Contacts:
Investors
Thomas DaltonHead of Investor & Public Relations,
CingulateTDalton@cingulate.com913-942-2301
Andy Brimmer / Amy Feng / Tim RagonesJoele Frank, Wilkinson
Brimmer
Katcherabrimmer@joelefrank.comafeng@joelefrank.comtragones@joelefrank.com212-355-4449
Media
Melyssa WeibleElixir Health Public
Relationsmweible@elixirhealthpr.com201-723-5805
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