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 quarter ended September 30, 2022 and
provided a clinical and business update. Highlights include a newly
executed Master Services Agreement (MSA) and multiple clinical
program updates on its lead Attention Deficit / Hyperactivity
Disorder (ADHD) candidate, CTx-1301 (dexmethylphenidate), as well
as anxiety asset CTx-2103 (buspirone HCl).
“The third quarter of 2022 marked multiple
inflection points for Cingulate, during which we initiated and
completed a food effect study to meet the New Drug Application
pharmacology requirement for our lead ADHD candidate, CTx-1301, and
finalized plans for a Phase 3 adult dose-optimization study that
will commence in the coming weeks,” said Shane J. Schaffer,
Cingulate Chairman and CEO.
“Our agreement with Societal CDMO secures the
manufacturing capacity and operational expertise to support our
products at each and every scale as we advance our clinical trial
activities toward the commercialization of these next-generation
products designed to improve patient outcomes .”
Cingulate Announces Partnership with
Societal CDMO
Cingulate announced it has executed an MSA with
Societal CDMO, Inc. (NASDAQ: SCTL), a contract development and
manufacturing organization (CDMO) dedicated to solving complex
formulation and manufacturing challenges in small molecule
therapeutic development.
With capabilities spanning pre-Investigational
New Drug (IND) development to commercial manufacturing and
packaging for a wide range of therapeutic dosage forms, Societal
CDMO will manufacture all clinical, registration, and commercial
batches of Cingulate’s lead ADHD candidate CTx-1301, an
investigational medication for the treatment of ADHD. Societal CDMO
will dedicate a specific manufacturing suite within its
Gainesville, GA facility and outfit it with proprietary equipment
owned by Cingulate. Clinical Update
-
CTx-1301: Cingulate advanced its clinical
program for CTx-1301 on the expedited approval pathway under
Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. As
part of that effort:In order to meet the pharmacology requirement
for the CTx-1301 New Drug Application (NDA) submission, the Company
initiated a food effect study in September 2022 which was completed
in October of 2022, with results expected to be available in
December 2022.A Phase 3 adult dose-optimization study to assess the
onset and duration of efficacy and safety of CTx-1301 in adults
with ADHD will commence in December 2022.With the newly executed
MSA with Societal CDMO, the CTx-1301 Phase 3 fixed-dose pediatric
and adolescent safety and efficacy study is expected to commence in
mid-2023 after the final two dosage strengths for this study are
manufactured. Results from the fixed-dose study are expected in
late 2023.Upon positive clinical results from the Phase 3 trials
and food effect study, the Company 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 toward an expedited approval pathway
under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic
Act. As part of that effort:Cingulate presented results from the
human formulation study of its lead anxiety candidate, CTx-2103
(buspirone), in September 2022 at the annual Psych Congress.
Pharmacokinetics were evaluated for this trimodal tablet providing
three (3) precisely timed doses of buspirone versus one immediate
release dose. In addition, scintigraphic imaging visualized transit
of the tablets through the gastrointestinal tract to confirm both
the site and onset of release, which will then be correlated with
pharmacokinetic data to establish the full release profile of the
CTx-2103 formulation.Based on the dissolution profile seen in the
data, the CTx-2103 30 mg tablet achieved the solubility required to
deliver a triple release of buspirone. The tablet was also
able to deliver the intended doses at three precise time
points. These results provide critical information as
Cingulate moves forward with designing the clinical program for
CTx-2103 in anxiety, the most common mental health concern in the
U.S.
- 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 the first half of 2024. If results from this
study are successful, pivotal Phase 3 clinical trials in all
patient segments for CTx-1302 will begin in 2024.
Third Quarter 2022 Results
- Cash Position: As
of September 30, 2022, Cingulate had $9.8 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 through the first quarter
of 2023. Cingulate is evaluating alternatives to raise additional
capital, including equity and debt financing.
- Research & Development
(R&D) Expenses: R&D expenses were $2.1 million for
the three months ended September 30, 2022, compared to $5.8 million
for the same period in 2021. R&D expenses were $7.1 million for
the nine months ended September 30, 2022, as compared to $7.1
million for the same period in 2021. The Company incurred a
one-time non-cash compensation charge to R&D totaling $4.6
million for the modification of profits interest units in the third
quarter of 2021. This charge was partially offset by increased
development activity in 2022 as compared to 2021 as the Company
began conducting a food effect study for CTx-1301 during the third
quarter of 2022 as well as study start-up activities for a Phase 3
fixed-dose pediatric and adolescent safety and efficacy study for
CTx-1301 during the first nine months of 2022. In addition,
manufacturing of the Phase 3 clinical supply for the fixed-dose
study began in the first quarter of 2022 with continued activity
through the third quarter of 2022. The Company has also incurred
costs in 2022 relating to a human formulation study for
CTx-2103.
- General and Administrative
(G&A) Expenses: G&A expenses were $1.8 million for
the three months ended September 30, 2022, compared to $9.4 million
for the same period in 2021. G&A expenses were $5.9 million for
the nine months ended September 30, 2022, as compared to $10.9
million for the same period in 2021. These decreases primarily
relate to a one-time non-cash compensation charge to G&A
totaling $8.1 million for the modification of profits interest
units in the third quarter of 2021, partially offset by 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 $4.0 million for the three months ended September 30, 2022,
compared to $15.3 million for the same period in 2021. Net loss was
$13.1 million for the nine months ended September 30, 2022, as
compared to $18.1 million for the same period in 2021. These
decreases in net loss 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.
About Societal CDMOSocietal
CDMO (NASDAQ: SCTL) is a bi-coastal contract development and
manufacturing organization (CDMO) with capabilities spanning
pre-Investigational New Drug (IND) development to commercial
manufacturing and packaging for a wide range of therapeutic dosage
forms with a primary focus in the area of small molecules. With an
expertise in solving complex manufacturing problems, Societal CDMO
is a leading CDMO providing therapeutic development, end-to-end
regulatory support, clinical and commercial manufacturing, aseptic
fill/finish, lyophilization, packaging and logistics services to
the global pharmaceutical market.
In addition to our experience in handling DEA
controlled substances and developing and manufacturing
modified-release dosage forms, Societal CDMO has the expertise to
deliver on our clients’ pharmaceutical development and
manufacturing projects, regardless of complexity level. We do all
of this in our best-in-class facilities, which total 145,000 square
feet, in Gainesville, Georgia and San Diego, California.
Societal CDMO: Bringing Science to Society. For
more information about Societal CDMO’s customer solutions, visit
societalcdmo.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.
Tables accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/b8f2fa4a-4992-4d2a-9817-683ed7fd1e8b
https://www.globenewswire.com/NewsRoom/AttachmentNg/cc5ee90f-9f82-485f-b8a4-770c71c48a65
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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