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 provided financial
results for the three months ended March 31, 2023, as well as a
clinical and business update. Among other highlights, the Company
announced it has obtained an additional $3 million of debt
financing, successfully completed the transfer of its proprietary
PTR™ manufacturing processes to Societal CDMO, Inc. (Societal) and
entered into a joint commercialization agreement with Indegene to
provide commercial support for CTx-1301 upon approval from the U.S.
Food and Drug Administration (FDA).
“We are excited to have reached several
important milestones,” said Cingulate Chairman & CEO Shane J.
Schaffer. “Cingulate has now answered the question as to how it
will commercialize CTx-1301 by entering into a joint
commercialization agreement with Indegene that substantially
reduces the risks and expenses associated with traditional
commercialization, and earlier this month, we announced the
successful transfer of Cingulate’s proprietary PTR manufacturing
processes to Societal CDMO in Gainesville, Georgia, keeping our
Phase 3 timelines on schedule.”
“Furthermore,” Schaffer continued, “we are
pleased to announce that we’ve received additional non-dilutive
financing from long-standing Cingulate investor and board member
Peter J. Werth. Capital will always be critical to Cingulate’s
long-term success, and as we look forward to multiple Phase 3
milestones later this summer, we thank Peter for this additional
financing and his steadfast support for Cingulate’s pipeline,
vision, and overall mission.”
Werth Family Investment Associates
Provides $3 Million of Debt Financing
Cingulate received an additional $3.0 million of
debt financing from Werth Family Investment Associates LLC (WFIA).
The $5.0 million promissory note, dated August 9, 2022, in favor of
WFIA was amended and restated to increase the principal amount to
$8.0 million with no changes to the other terms of the note. The
note is unsecured with interest accruing at 15% per annum.
Outstanding principal and all accrued and unpaid interest is due
and payable on August 8, 2025 unless accelerated due to an event of
default, and WFIA has the right during the first five business days
of each calendar quarter to demand payment of all outstanding
principal and interest 120 days following notice to Cingulate.
WFIA owns 975,165 shares of our common stock and Peter
J. Werth, a member of the Company’s Board of Directors and the
manager of WFIA, owns 21,849 shares of our common stock.
Cingulate Completes Transfer of
Proprietary PTR™ Manufacturing Processes to Societal
CDMO
In April 2023, Cingulate successfully completed
the transfer of its proprietary PTR™ manufacturing processes for
its lead candidate, CTx-1301 (dexmethylphenidate), to Societal, a
contract development and manufacturing organization (CDMO)
dedicated to solving complex formulation and manufacturing
challenges primarily in small molecule therapeutic development.
Societal is producing a scalable supply of CTx-1301 for Cingulate’s
ongoing and upcoming Phase 3 trials in the manufacturing suite
within Societal’s Gainesville, Georgia facility that is outfitted
with equipment supplied by Cingulate.
Cingulate, Indegene Announce Joint
Commercialization Agreement for Lead ADHD Candidate
CTx-1301
In March 2023, Cingulate announced a joint
commercialization agreement with Indegene, a comprehensive life
sciences commercialization company, to provide commercial support
for Cingulate’s lead candidate CTx-1301 (dexmethylphenidate), a
novel, investigational treatment being developed as a true,
once-daily stimulant medication for attention deficit/hyperactivity
disorder (ADHD).
The agreement spans cross-functional services
through an omnichannel marketing approach uniquely designed to
successfully manage pre-commercial support during Cingulate’s Phase
3 clinical trials and to effectively commercialize CTx-1301
nationwide following potential FDA approval.
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
Phase 3 adult dose-optimization study in December 2022 to assess
onset and duration of efficacy and safety in adults with ADHD,
first cohort has been completed and the second cohort is near
completion. Results are expected in the third quarter of 2023.
The 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 addition,
Cingulate is planning to initiate a Phase 3 pediatric and
adolescent dose-optimization classroom study in the third quarter
of 2023 to assess onset and duration and efficacy and safety in
patients with ADHD. 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
or without food.
Assuming positive
clinical results from the Phase 3 trials, Cingulate plans to submit
the NDA for CTx-1301 in mid-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 we expect to
occur in the third quarter of 2023 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.
First Quarter Results
- Cash Position: As
of March 31, 2023, Cingulate had $1.7 million in cash and cash
equivalents. Based on the Company’s current operating plan and with
the proceeds from the WFIA debt financing, Cingulate expects its
cash and cash equivalents will enable the Company to fund its
research and development and operating expenditures into the third
quarter of 2023. Cingulate entered into an At The Market Offering
Agreement (ATM Agreement) with H.C. Wainwright & Co., LLC, as
sales agent (Wainwright), in January 2023, pursuant to which
Cingulate may offer and sell, from time to time through Wainwright,
shares of its common stock for aggregate proceeds of up to $4.97
million (upon the terms and subject to the conditions and
limitations set forth in the ATM Agreement). In April 2023,
Cingulate entered into a purchase agreement with Lincoln Park
Capital Fund LLC, pursuant to which Lincoln Park has agreed to
purchase up to an aggregate of $12.0 million of common stock
(upon the terms and subject to the conditions and limitations set
forth in the purchase agreement) from time to time and at
Cingulate’s sole discretion over the 36-month term of
the purchase agreement. Cingulate issued 368,023 shares of
common stock to Lincoln Park as consideration for their commitment
to purchase its common stock. Management is also evaluating
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 $2.1 million for the three months ended March
31, 2023, compared to $2.8 million for the same period in 2022.
This change was primarily a result of a decrease in manufacturing
costs for CTx-1301 during the three month period ended March 31,
2023, as the three month period ended March 31, 2022 included the
manufacturing of clinical supply for Phase 3 CTx-1301 clinical
trials; whereas the manufacturing activity in the three months
ended March 31, 2023 primarily included expenses related to the
build out of our manufacturing suite at our CDMO. This decrease in
manufacturing expense was slightly offset by an increase in
clinical and regulatory costs as we initiated a Phase 3 clinical
trial for CTx-1301 in the first quarter of 2023.
- General and Administrative (G&A) Expenses:
G&A expenses were $1.7 million for the three months ended March
31, 2023, compared to $2.2 million for the same period in 2022.
This change was primarily the result of a decrease in legal and
professional fees of $0.3 million and a decrease in insurance of
$0.3 million. The decrease in professional fees was related to the
timing of services performed for our annual audits and the decrease
in insurance costs was 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 $4.0 million for the
three months ended March 31, 2023, compared to $5.0 million for the
same period in 2022. The decrease in net loss is due to the
decreases in R&D and G&A expenses 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 |
|
|
March
31, |
|
December
31, |
|
2023 |
|
2022 |
Cash, cash equivalents and short-term investments |
$ |
1,738,760 |
|
|
$ |
5,356,276 |
|
Total assets |
$ |
7,162,957 |
|
|
$ |
11,405,057 |
|
Total liabilities |
$ |
7,081,343 |
|
|
$ |
7,523,035 |
|
Accumulated deficit |
$ |
(73,413,383 |
) |
|
$ |
(69,408,496 |
) |
Total stockholders' equity |
$ |
81,614 |
|
|
$ |
3,882,022 |
|
Cingulate
Inc. |
Consolidated
Statements of Operations |
|
|
|
Three Months
Ended March 31, |
|
2023 |
|
2022 |
Operating
expenses: |
|
|
|
Research and development |
$ |
2,128,616 |
|
|
$ |
2,762,284 |
|
General and administrative |
|
1,721,379 |
|
|
|
2,247,060 |
|
Operating loss |
|
(3,849,995 |
) |
|
|
(5,009,344 |
) |
|
|
|
|
Interest and other income (expense), net |
|
(154,892 |
) |
|
|
5,833 |
|
Loss before
income taxes |
|
(4,004,887 |
) |
|
|
(5,003,511 |
) |
Income tax
benefit (expense) |
|
- |
|
|
|
- |
|
|
|
|
|
Net
loss |
|
(4,004,887 |
) |
|
|
(5,003,511 |
) |
Net loss per
share of common stock, basic and diluted |
$ |
(0.35 |
) |
|
$ |
(0.44 |
) |
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-123-0524
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