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 and 12 months ended December 31,
2022, and provided a clinical and business update. Highlights
include multiple clinical updates on CTx-1301, the Company’s lead
candidate being investigated as a true, once-daily treatment for
attention deficit/hyperactivity disorder (ADHD).
“The fourth quarter of 2022 was instrumental for
Cingulate, during which we executed a Master Services Agreement
with Societal CDMO to manufacture CTx-1301, and successfully
initiated our Phase 3 Adult Onset and Duration Trial,” said Shane
J. Schaffer, PharmD, Cingulate Chairman and CEO. “With the first of
two CTx-1301 Phase 3 studies underway and the second planned to
begin mid-2023, we’ve made significant progress towards bringing
the first true, once-daily stimulant to market that addresses all
major unmet needs in ADHD.”
CTx-1301 is a novel, investigational, trimodal,
extended-release tablet formulation of dexmethylphenidate, a
compound approved by the FDA for the treatment of ADHD.
Phase 3 Adult Dose-Optimization Trial on
Track for Q3 2023 ResultsThe Phase 3 CTx-1301-022
(NCT05631626) trial is evaluating the efficacy and safety of
CTx-1301 in adults with ADHD in an laboratory classroom setting,
which has been used extensively to evaluate the efficacy of ADHD
medications. Following initiation in December, the dose
optimization phase for the first cohort has commenced.
The trial is being led by Ann C. Childress, MD,
practicing psychiatrist and president of the American Professional
Society for ADHD and Related Disorders (APSARD). Dr. Childress has
conducted over 180 clinical studies and is considered a preeminent
global ADHD expert.
“While we have many approved stimulant
medications at our disposal as clinicians, my long-standing desire
in over 20-years of clinical practice is to utilize a product that
provides entire active-day efficacy, providing a quick onset of
action and a duration into the early evening. Afternoon booster
doses are our current work-around, but these lead to issues with
adherence, optimal efficacy, and the potential for abuse and
diversion, and may be accompanied with unwanted side effects.
Having a product like CTx-1301 would be beneficial to patients and
providers, as it is designed to avoid booster doses and address the
long-standing unmet needs facing our patients with ADHD,” said Dr.
Childress.
Clinical Update
-
CTx-1301: Cingulate advanced its clinical
program for CTx-1301 on the streamlined approval pathway under
Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. As
part of that effort:
Cingulate initiated a
CTx-1301 Phase 3 adult dose-optimization study in December 2022 to
assess onset and duration of efficacy and safety in adults with
ADHD, dose optimization of the first cohort has commenced and
results are expected in the third quarter of 2023.
In addition, the
CTx-1301 Phase 3 fixed-dose pediatric and adolescent safety and
efficacy study is expected to commence in mid-2023; results are
expected in the first quarter of 2024.
In order to meet the
pharmacology requirement for the CTx-1301 New Drug Application
(NDA) submission, Cingulate completed a food effect study in
October of 2022, which demonstrated that CTx-1301 can be taken with
our without food.
Assuming positive
clinical results from the Phase 3 trials, Cingulate plans to submit
the NDA for CTx-1301 in the first half of 2024 under the Section
505(b)(2) pathway.
-
CTx-2103: Cingulate is constructing a
clinical program for CTx-2103 on the streamlined approval pathway
under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic
Act. Based on the pharmacokinetic profile seen in the formulation
study which was completed in September 2022, CTx-2103 achieved the
desired triple release of buspirone. These positive results
provided the critical information required to allow the Company to
request a Pre-IND meeting with the FDA to discuss the design of the
Company’s clinical and regulatory programs for CTx-2103, which is
expected to allow for a potential IND filing in the fourth quarter
of 2023.
- CTx-1302: A
Phase 1/2 bioavailability study in ADHD patients for CTx-1302
(dextroamphetamine), Cingulate’s second asset for the treatment of
ADHD, is planned for mid-2024. If results from this study are
successful, pivotal Phase 3 clinical trials in all patient segments
for CTx-1302 are expected to begin in late 2024 or early 2025.
Fourth Quarter and Full Year
Results
- Cash Position: As
of December 31, 2022, Cingulate had $5.4 million in cash and cash
equivalents, as compared to $16.5 million in cash and cash
equivalents as of December 31, 2021. Based on the Company’s current
operating plan, Cingulate expects its cash and cash equivalents
will enable the Company to fund its research and development and
general and administrative expenditures into the second quarter of
2023. In January 2023, Cingulate entered into an At The Market
Offering Agreement (the “ATM Agreement”) with H.C. Wainwright &
Co., LLC, as sales agent (“Wainwright”), pursuant to which we may
offer and sell, from time to time through Wainwright, shares of our
common stock for aggregate proceeds of up to $2.65 million. To
date, Cingulate has not made any sales under the ATM Agreement. In
addition, Cingulate is evaluating other alternatives to raise
additional capital, including equity and debt
financing.Research & Development (R&D)
Expenses: R&D expenses were $1.9 million for the three
months ended December 31, 2022, compared to $1.3 million for the
same period in 2021. R&D expenses were $9.0 million for the
year ended December 31, 2022, as compared to $8.4 million for the
year ended December 31, 2021. This increase was related to a
significant increase in clinical and manufacturing costs for
CTx-1301 as Cingulate completed a food effect study in the fourth
quarter of 2022 and initiated the Phase 3 adult dose-optimization
study in late 2022. In addition, the Company’s manufacturing costs
increased in 2022 relating to the production of clinical supply for
Phase 3 trials of CTx-1301. These increases were offset by a
decrease in personnel expenses due to the recording of $4.6 million
to R&D expense in 2021 for a one-time noncash compensation
charge for the modification of profits interest units (PIUs). The
decrease in personnel costs due to the one-time noncash charge was
offset by annual pay increases in 2022 and added personnel in late
2021 in anticipation of increased clinical activity.
- General and Administrative
(G&A) Expenses: G&A expenses were $2.5 million for
the three months ended December 31, 2022, compared to $1.4 million
for the same period in 2021. G&A expenses were $8.5 million for
the year ended December 31, 2022, as compared to $12.3 million for
the year ended December 31, 2021. Personnel expenses decreased,
primarily related to the recording of $8.1 million to G&A
personnel expenses of a one-time noncash compensation charge in
2021 relating to the modification of PIUs. This decrease in
personnel expenses due to the noncash compensation charge was
offset by an increase in salaries expense due to the addition of
personnel in late 2021 as the Company was preparing to operate as a
public company. The decrease in personnel expenses was offset by
increases in other expenses, including legal fees and audit fees
primarily due to increased activity in late 2022 in preparation for
future capital raises. In addition, insurance costs increased
significantly due to the directors and officers insurance premium
which is much higher for a publicly traded company.
- Net Loss: Net loss
was $4.6 million for the three months ended December 31, 2022,
compared to $2.7 million for the same period in 2021. Net loss was
$17.7 million for the year ended December 31, 2022, as compared to
$20.7 million for the year ended December 31, 2021. The decrease in
net loss for the full year primarily relate to a one-time non-cash
compensation charge totaling $12.7 million for the modification of
profits interest units in the third quarter of 2021, partially
offset by increased development activity as well as the increase in
G&A expenses relating to additional costs to operate as a
public company in 2022, both described above.
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 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.
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Cingulate Inc. |
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Consolidated Balance Sheet Data |
|
|
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December 31, |
|
December 31, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
Cash, cash equivalents and short-term investments |
|
$ |
5,356,276 |
|
|
$ |
16,493,678 |
|
|
Working capital |
|
$ |
856,852 |
|
|
$ |
17,705,601 |
|
|
Total assets |
|
$ |
11,405,057 |
|
|
$ |
22,886,257 |
|
|
Total liabilities |
|
$ |
7,523,035 |
|
|
$ |
2,042,715 |
|
|
Accumulated deficit |
|
$ |
(69,408,496 |
) |
|
$ |
(51,732,264 |
) |
|
Total stockholders' equity |
|
$ |
3,882,022 |
|
|
$ |
20,843,542 |
|
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Cingulate Inc. |
|
Consolidated Statements of Operations |
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Three Months Ended December 31, |
|
Year Ended December 31, |
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2022 |
|
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2021 |
|
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2022 |
|
|
|
2021 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,931,654 |
|
|
$ |
1,262,976 |
|
|
$ |
8,995,280 |
|
|
$ |
8,410,489 |
|
|
General and administrative |
|
|
2,543,371 |
|
|
|
1,384,150 |
|
|
|
8,506,438 |
|
|
|
12,268,909 |
|
|
Operating loss |
|
|
(4,475,025 |
) |
|
|
(2,647,126 |
) |
|
|
(17,501,718 |
) |
|
|
(20,679,398 |
) |
|
|
|
|
|
|
|
|
|
|
|
Interest and other income (expense), net |
|
|
(130,002 |
) |
|
|
(6,599 |
) |
|
|
(174,514 |
) |
|
|
(30,593 |
) |
|
Loss before income taxes |
|
|
(4,605,027 |
) |
|
|
(2,653,725 |
) |
|
|
(17,676,232 |
) |
|
|
(20,709,991 |
) |
|
Income tax benefit (expense) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(4,605,027 |
) |
|
|
(2,653,725 |
) |
|
|
(17,676,232 |
) |
|
|
(20,709,991 |
) |
|
Net loss per share of common stock, basic and diluted |
|
$ |
(0.41 |
) |
|
$ |
(0.32 |
) |
|
$ |
(1.56 |
) |
|
$ |
(2.79 |
) |
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Investor RelationsThomas DaltonVP, Investor
& Public Relations, Cingulate
Inc.TDalton@cingulate.com913-942-2301
Matt KrepsDarrow Associatesmkreps@darrowir.com214-597-8200
Media RelationsMelyssa WeibleElixir Health
Public Relationsmweible@elixirhealthpr.com201-723-5805
CING-US-119-0324
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