Cingulate Inc. (NASDAQ: CING) (Cingulate or the Company), 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 provided financial results for the quarter ended June 30,
2023, as well as a clinical and business update. Among other
highlights, the Company announced a $1 million dollar investment
from Werth Family Investment Associates LLC (WFIA), top-line
results following the completion of a Phase 3 Adult Efficacy and
Safety Trial of CTx-1301, and the initiation of the CTx-1301 Phase
3 pediatric and adolescent studies.
“We believe the Phase 3 adult efficacy and
safety trial is a significant clinical milestone and validation of
what Cingulate has set out to accomplish: create the only ADHD
medication that overcomes the major unmet needs of currently
available treatments with clear and unmatched differentiation,”
said Shane J. Schaffer, PharmD, Chairman and CEO, Cingulate.
Dr. Raul Silva, MD, Chief Science Officer added,
“We are pleased with the results from this trial and believe they
will be replicated in the ongoing Phase 3 pediatric and adolescent
trials.”
Werth Family Investment Associates
Provides $1 Million InvestmentOn August 11, 2023,
Cingulate entered into a Securities Purchase Agreement with WFIA
and issued, in a private placement priced at the market under
Nasdaq rules, 1,823,155 shares of the Company’s common stock, par
value $0.0001 per share at a purchase price per share of $0.5485,
for aggregate gross proceeds to the Company of approximately $1.0
million.
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 completed a Phase 3 adult
dose-optimization study in June 2023 and announced top-line results
in July 2023. Full results from the study, including safety
data and patient reported outcomes from a pre- and post-trial
questionnaire, have been accepted for presentation at the US Psych
Congress in September 2023.
The Phase 3 CTx-1301-022 study assessed efficacy
and safety along with onset and duration of CTx-1301 in an adult
laboratory classroom. This single-site, small pilot study in 21
adults (age range: 18-55 years) with ADHD was not intended to nor
did achieve statistical significance on the primary efficacy
endpoint. The findings did demonstrate that CTx-1301 demonstrated
an average effect size of 1.79, greater than twice the effect size
of current ADHD product across the entire active-day duration. A
meta-analysis conducted by Faraone and Glatt (Clinical Psychiatry
71:6 June 2010) using 11 published studies with long-acting
stimulants in adults demonstrated an average effect size of 0.73.
Furthermore, CTx-1301 was well tolerated with one subject
randomized to CTx-1301 experiencing treatment emergent adverse
events (TEAEs), while 3 of subjects that were randomized to placebo
experienced TEAEs.
In addition to the Phase 3 adult
dose-optimization study, Cingulate initiated its pivotal Phase 3
fixed-dose pediatric and adolescent safety and efficacy study in
July 2023 and a Phase 3 dose-optimization onset and duration study
in pediatric patients in early August 2023. The pediatric and
adolescent study – designated as the Mastery Study – and the
pediatric onset and duration study are now recruiting patients.
Assuming positive clinical results from the
upcoming Phase 3 trials, Cingulate plans to submit a New Drug
Application (NDA) for CTx-1301 in the second half of 2024 under the
Section 505(b)(2) pathway.
-
CTx-2103: Cingulate is constructing a
clinical program for CTx-2103 (buspirone) for the treatment of
anxiety 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 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
occur in the fourth quarter of 2023 to allow for a potential IND
filing in the first quarter of 2024.
- 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.
Second Quarter Results
- Cash Position: As
of June 30, 2023, Cingulate had $0.3 million in cash and cash
equivalents. Subsequent to June 30, 2023, Cingulate raised a total
of $1.8 million in net proceeds from the At the Market Offering
Agreement with H.C. Wainwright & Co., LLC and the purchase
agreement with Lincoln Park Capital Fund LLC. The additional
$1million capital investment from WFIA was closed on August 11,
2023. Cingulate expects its cash and cash equivalents will enable
the Company to fund its research and development and operating
expenditures into September 2023.
Management continues to evaluate additional
strategies to obtain funding, which may include additional
offerings of common stock, issuance of debt, or other capital
sources, including potential collaborations with other companies or
other strategic transactions.
Research & Development (R&D)
Expenses: R&D expenses were $4.5 million for the three
months ended June 30, 2023, compared to $2.2 million for the same
period in 2022. R&D expenses were $6.6 million for the six
months ended June 30, 2023, compared to $4.9 million for the same
period in 2022. These changes are the result of increased
development activity in 2023 as compared to 2022. The Company
initiated the Phase 3 adult dose-optimization study for CTx-1301 in
late 2022 and completed it in June 2023. Additionally, the Company
completed manufacturing of Phase 3 clinical supply for CTx-1301 in
the first half of 2023, and incurred start-up activities for two
Phase 3 studies for CTx-1301: the pediatric dose optimization study
and the fixed dose pediatric and adolescent safety and efficacy
study.
General and Administrative (G&A)
Expenses: G&A expenses were $1.9 million for both the
three months ended June 30, 2023 and the three months ended June
30, 2022. G&A expenses were $3.6 million for the six months
ended June 30, 2023, compared to $4.1 million for the same period
in 2022. This change was primarily the result of a decrease in
insurance costs related to a decline in the annual directors’ and
officers’ insurance policy premium, which was renewed in December
of 2022.
Net Loss: Net loss was $6.6
million for the three months ended June 30, 2023, compared to $4.0
million for the same period in 2022. Net loss was $10.6 million for
the six months ended June 30, 2023, compared to $9.0 million for
the same period in 2022. The increases in net loss are primarily
due to the increases in development activity as 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 10, 2023. 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 |
|
|
June
30, |
|
December
31, |
|
|
2023 |
|
|
|
2022 |
|
Cash, cash equivalents and short-term investments |
$ |
349,831 |
|
|
$ |
5,356,276 |
|
Total assets |
$ |
5,227,447 |
|
|
$ |
11,405,057 |
|
Total liabilities |
$ |
11,325,968 |
|
|
$ |
7,523,035 |
|
Accumulated deficit |
$ |
(80,029,692 |
) |
|
$ |
(69,408,496 |
) |
Total stockholders' equity |
$ |
(6,098,521 |
) |
|
$ |
3,882,022 |
|
|
|
|
|
|
|
|
|
|
Cingulate
Inc. |
Consolidated
Statements of Operations |
|
|
|
|
|
|
|
|
|
Three Months
Ended June 30, |
|
Six Months
Ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4,455,927 |
|
|
$ |
2,178,226 |
|
|
$ |
6,584,543 |
|
|
$ |
4,940,510 |
|
General and administrative |
|
|
1,906,442 |
|
|
|
1,870,591 |
|
|
|
3,627,821 |
|
|
|
4,117,651 |
|
Operating loss |
|
|
(6,362,369 |
) |
|
|
(4,048,817 |
) |
|
|
(10,212,364 |
) |
|
|
(9,058,161 |
) |
|
|
|
|
|
|
|
|
|
Interest and other income (expense), net |
|
|
(253,940 |
) |
|
|
8,370 |
|
|
|
(408,832 |
) |
|
|
14,203 |
|
Loss before
income taxes |
|
|
(6,616,309 |
) |
|
|
(4,040,447 |
) |
|
|
(10,621,196 |
) |
|
|
(9,043,958 |
) |
Income tax
benefit (expense) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
|
(6,616,309 |
) |
|
|
(4,040,447 |
) |
|
|
(10,621,196 |
) |
|
|
(9,043,958 |
) |
Net loss per
share of common stock, basic and diluted |
|
$ |
(0.57 |
) |
|
$ |
(0.36 |
) |
|
$ |
(0.92 |
) |
|
$ |
(0.80 |
) |
|
|
|
|
|
|
|
|
|
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
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