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 months ended March 31, 2022, and
provided a clinical and business update, which includes the
announcement of first subject dosing in its human formulation study
of CTx-2103 (buspirone) for the treatment of anxiety.
“At its core, Cingulate has maintained a
primary focus on addressing patients’ suboptimal treatment
outcomes and overcoming unmet needs due to the limitations of
current standard of care treatments,” said Cingulate Chief Science
Officer Raul Silva, M.D. “Anxiety affects millions of individuals
every day, and many of the available treatments are either
addicting or abusable, of abbreviated duration, and need to be
taken up to three times daily. CTx-2103 has the potential to
address and remedy these shortcomings through a precise,
single-dose therapeutic approach.”
Clinical and Business Update
CTx-2103: Cingulate has
embarked on a program to develop CTx-2103 (buspirone), which would
expand the PTR platform into the anxiety therapeutic category and
extend the potential of PTR technology in another indication where
multiple daily doses are required and the timing, style, and ratio
of this medication delivery is paramount. The Company initiated a
human formulation study for CTx-2103 in May 2022 and haved dosed
the first subject. Results from the study are expected in July
2022, and the site for the study is BDD Pharma, Glasgow, Scotland,
UK.
Buspirone is the first nonbenzodiazepine
anxiolytic introduced for the treatment of generalized anxiety
disorder, first synthesized in 1968 and originally patented in
1975. The original indication was for the management of anxiety
disorders or the short-term relief of anxiety. The efficacy of
buspirone has been demonstrated in generalized anxiety disorder
(GAD) and may also be used for the treatment of other neurological
and psychiatric disorders.
CTx-2103 will be designed as a once-daily,
multi-dose tablet with what the Company believes will be clear
differentiation and compelling advantages over standard treatment
options. In 2021, the U.S. anxiety market exceeded $5.5 Bn with
buspirone sales of nearly $2Bn.
CTx-1301: Cingulate has
designed its clinical program for CTx-1301 (dexmethylphenidate),
the Company’s lead investigational asset for the treatment of
Attention Deficit/Hyperactivity Disorder (ADHD), based on U.S. Food
and Drug Administration (FDA) feedback regarding its 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, with dosing of the first patient
targeted in the second half of 2022, and (2) a pediatric safety and
efficacy dose-optimization study to assess the onset and duration
of efficacy, also targeted to begin in the second half of 2022.
Cingulate has experienced certain manufacturing delaysts contract
manufacturing organization (CMO) has experienced operational
resource issues in the manufacturing and delivery of all dosage
strengths of clinical supply for the CTx-1301 fixed-dose study.
This has delayed the first patient dosed, initially targeted for
the second quarter of 2022. Manufacturing of the final two dosage
strengths is expected to begin in the second or third quarter of
this year. Results from the fixed-dose study are expected in late
2022/early 2023. Assuming Cingulate receives positive clinical
results from its Phase 3 trials, the Company still plans to submit
a New Drug Application (NDA) for CTx-1301 in late 2023 under the
Section 505(b)(2) pathway.
In order to achieve the filing of our NDA for
CTx-1301 in late 2023 for potential FDA approval, Cingulate
believes that it will need approximately $21.5 million of
additional capital, which amount has increased approximately $6.5
million from the original estimate due primarily to an estimated
six months of additional operating expenses resulting from the
manufacturing delay. Additionally, inflation, additional clinical
site expenses and manufacturing costs are expected. Cingulate will
also need additional capital to advance its other programs. The
Company is evaluating alternatives to raise additional capital,
including equity and debt financing and non-dilutive strategic
collaborations in the U.S. and abroad. In addition, Cingulate
continues to evaluate commercial collaborations and strategic
relationships with established pharmaceutical companies, which
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.
First Quarter Results
Cash Position: As of March 31,
2022, Cingulate had $12.6 million in cash and cash equivalents, as
compared to $16.5 million in cash and cash equivalents as of
December 31, 2021. Cash and cash equivalents as of March 31, 2022,
reflect the net proceeds of the Company’s IPO of approximately
$20.4 million, which closed on December 10, 2021, less development
and operating expenses which occurred in late 2021 and the first
quarter of 2022. Based on the Company’s current operating plan,
Cingulate expects its cash and cash equivalents as of March 31,
2022, 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 $2.8 million for the three months ended
March 31, 2022, compared to $0.6 million for the same period in
2021. Development activity has been increasing since late 2021 as
the Company is active in study start-up phase of a Phase 3 clinical
study, the fixed-dose pediatric and adolescent safety and efficacy
study for CTx-1301. In addition, manufacturing the Phase 3 clinical
supply for this study began in the first quarter of 2022. The
Company has also incurred costs in the first quarter of 2022
relating to a human formulation study for CTx-2103.
G&A Expenses: General and
administrative expenses were $2.2 million for the three months
ended March 31, 2022, compared to $0.8 million for the same period
in 2021. This increase relates to certain costs which have
increased for the Company operating as a public company, including
Directors and Officers insurance, audit and other professional fees
and added personnel.
Net Loss: Net loss was $5.0
million for the three months ended March 31, 2022, compared to $1.3
million for the same period in 2021. This increase relates to the
increased development activity as well as the increase in G&A
expenses relating to additional costs to operate as a public
company, both 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, 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 March 28, 2022. 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
|
|
March 31, |
|
|
Dec. 31, |
|
|
|
2022 |
|
|
2021 |
|
Cash, cash equivalents and short-term investments |
|
$ |
12,615,113 |
|
|
$ |
16,493,678 |
|
Working capital |
|
|
12,942,662 |
|
|
|
17,705,601 |
|
Total assets |
|
|
18,432,681 |
|
|
|
22,886,257 |
|
Total liabilities |
|
|
2,414,080 |
|
|
|
2,042,715 |
|
Accumulated deficit |
|
|
(56,735,775 |
) |
|
|
(51,732,264 |
) |
Total stockholders’
equity |
|
|
16,018,601 |
|
|
|
20,843,542 |
|
Cingulate
Inc.Consolidated Statements of
Operations
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
2,762,284 |
|
|
$ |
562,519 |
|
General and administrative |
|
|
2,247,060 |
|
|
|
767,645 |
|
Operating
loss |
|
|
(5,009,344 |
) |
|
|
(1,330,164 |
) |
|
|
|
|
|
|
|
|
|
Interest and other income
(expense), net |
|
|
5,833 |
|
|
|
(3,759 |
) |
Loss before income taxes |
|
|
(5,003,511 |
) |
|
|
(1,333,923 |
) |
Income tax benefit
(expense) |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,003,511 |
) |
|
$ |
(1,333,923 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.44 |
) |
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares used in computing net loss per share of common stock, basic
and diluted |
|
|
11,309,412 |
|
|
|
N/A |
|
Investor RelationsThomas DaltonHead of Investor
& Public Relations, Cingulate
Inc.Tdalton@cingulate.com 913-942-2301
Matt KrepsDarrow Associatesmkreps@darrowir.com 214-597-8200
Media RelationsMelyssa Weible Elixir
Health Public
Relationsmweible@elixirhealthpr.com 201-723-5805
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