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 September
30, 2023, as well as a clinical and business update.
Among other highlights, the Company announced data from its
Phase 3 adult efficacy and safety trial, closed a $4 million public
offering in September 2023 and converted of $5.8 million of debt
into Cingulate equity in September 2023.
“We are pleased with the full data received from the Phase 3
adult efficacy and safety trial, and believe it amplifies our view
that the effect size seen with CTx-1301 is positioned to provide
substantial benefit to the millions of ADHD patients,” said
Cingulate Chairman and CEO Shane J. Schaffer.
Cingulate Closed a $4M Public Offering
On September 11, 2023, Cingulate entered into a Securities
Purchase Agreement pursuant to which it issued 1,720,000 shares of
common stock, pre-funded warrants to purchase up to an aggregate of
5,205,208 shares of common stock, Series A warrants to purchase up
to 6,925,208 shares of common stock and Series B warrants to
purchase up to 3,462,604 shares of common stock. The offering
closed on September 13, 2023. The combined purchase price per share
of common stock and accompanying warrants was $0.5776. The combined
purchase price per pre-funded warrant and accompanying warrants was
$0.5775, which represents the public offering price per share of
common stock and accompanying warrants less the $0.0001 per share
exercise price for each pre-funded warrant. The Series A warrants
have an exercise price of $0.5776 per share and will expire
November 3, 2028, and the Series B warrants have an exercise price
of $0.5776 per share and will expire November 3, 2025. The
Company’s stockholders approved the issuance of common stock upon
the exercise of the Series A and Series B warrants at a special
meeting held on November 3, 2023. H.C. Wainwright & Co. acted
as the exclusive placement agent for the offering.
Werth Family Investment Associates Converted $5.8M of
Debt into Cingulate Equity On September 8, 2023, Werth
Family Investment Associates, LLC (“WFIA”), the manager of which is
Peter J. Werth, a member of the Cingulate board of directors,
converted $5.8 million of debt and accrued interest into pre-funded
warrants to purchase 6,838,235 shares of Cingulate common stock, at
a conversion price of $0.85 per pre-funded warrant. The closing
price of Cingulate’s common stock on Nasdaq on September 8, 2023
was $0.5776 per share. The pre-funded warrants issued to WFIA have
no expiration date and are exercisable immediately at an exercise
price of $0.0001 per share, subject to a beneficial ownership
blocker of 19.99%.
Clinical Update
- CTx-1301: Cingulate presented full
results from the Phase 3 adult efficacy and safety study of its
lead candidate, CTx-1301 (dexmethylphenidate), for the treatment of
attention deficit/hyperactivity disorder (ADHD), on September 8,
2023, at the 36th Annual Psych Congress, in Nashville,
TN. A poster describing this data was selected as a finalist for
the Psych Congress’s First Annual Poster Awards. The Phase 3
CTx-1301-022 study (NCT05631626) assessed efficacy
and safety along with onset and duration of CTx-1301 in 21 adults
(age range: 18-55 years) with ADHD in an adult laboratory classroom
setting. The study was not powered for statistical significance,
nor was it achieved on the primary efficacy endpoint, but
demonstrated a trend toward significance in improving Permanent
Product Measure of Performance (PERMP) scores with CTx-1301
compared to placebo. Clinical Global Impression Scale [CGI-S])
scores with CTx-1301 compared to placebo also showed significant
improvements with a 28.6% reduction and a p-value of < 0.001.
CTx-1301 demonstrated a reduction in Adult ADHD Investigator
Symptom Rating Scale (AISRS) scores during the dose-optimization
period. During the randomized placebo-controlled period, CTx-1301
demonstrated a reduction in AISRS scores with an effect size of
5.45 and a p-value of <0.001. Cingulate commenced the pivotal
Phase 3 fixed-dose pediatric and adolescent safety and efficacy
study in late July 2023 and a Phase 3 pediatric dose-optimization
onset and duration study in early August 2023, with results
expected in the first half of 2024. 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 a 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. Based on feedback from the FDA, the Company
will work towards an IND filing in the first half 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
the second half of 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 2025.
Third Quarter Results
Cash Position: As of September
30, 2023, Cingulate had $2.0 million in cash and cash equivalents.
Cingulate expects its cash and cash equivalents will enable the
Company to fund its research and development and operating
expenditures through mid-November 2023.
Management continues to evaluate additional
strategies to obtain funding, which may include additional equity
offerings, 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 $3.9 million for the three
months ended September 30, 2023, compared to $2.1 million for the
same period in 2022. R&D expenses were $10.5 million for the
nine months ended September 30, 2023, compared to $7.1 million for
the same period in 2022. These changes are the result of increased
development activity in 2023 as compared to 2022. The Company
incurred expenses in connection with two Phase 3 studies for
CTx-1301 that were initiated during the third quarter of 2023, the
pivotal fixed dose pediatric and adolescent safety and efficacy
study and the pediatric dose-optimization onset and duration study.
In addition, the Company initiated the Phase 3 adult
dose-optimization study for CTx-1301 in late 2022 and completed it
in June 2023.
General and Administrative (G&A)
Expenses: G&A expenses were $1.8 million for both the
three months ended September 30, 2023 and the three months ended
September 30, 2022. G&A expenses were $5.5 million for the nine
months ended September 30, 2023, compared to $6.0 million for the
same period in 2022. Insurance costs decreased during the three and
nine months ended September 30, 2023 related to a decline in the
annual directors’ and officers’ insurance policy premium, which was
renewed in December of 2022. These decreases were offset by an
increase in legal fees related to capital raise activities and an
increase in personnel expenses resulting from the addition of
clinical personnel and annual compensation increases for the three
and nine months ended September 30, 2023, respectively.
Net Loss: Net loss was $6.0
million for the three months ended September 30, 2023, compared to
$4.0 million for the same period in 2022. Net loss was $16.6
million for the nine months ended September 30, 2023, compared to
$13.0 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 |
|
|
|
September
30, |
|
December
31, |
|
|
|
2023 |
|
|
|
2022 |
|
Cash, cash equivalents and short-term investments |
|
$ |
1,986,313 |
|
|
$ |
5,356,276 |
|
Total assets |
|
$ |
5,870,258 |
|
|
$ |
11,405,057 |
|
Total liabilities |
|
$ |
5,966,592 |
|
|
$ |
7,523,035 |
|
Accumulated deficit |
|
$ |
(86,008,746 |
) |
|
$ |
(69,408,496 |
) |
Total stockholders' equity |
|
$ |
(96,334 |
) |
|
$ |
3,882,022 |
|
Cingulate
Inc. |
|
Consolidated
Statements of Operations |
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended September 30, |
|
Nine Months
Ended September 30, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,923,852 |
|
|
$ |
2,123,114 |
|
|
$ |
10,508,395 |
|
|
$ |
7,063,626 |
|
|
General and administrative |
|
|
1,825,822 |
|
|
|
1,845,248 |
|
|
|
5,453,643 |
|
|
|
5,963,067 |
|
|
Operating loss |
|
|
(5,749,674 |
) |
|
|
(3,968,362 |
) |
|
|
(15,962,038 |
) |
|
|
(13,026,693 |
) |
|
|
|
|
|
|
|
|
|
|
|
Interest and other income (expense), net |
|
|
(229,380 |
) |
|
|
(58,885 |
) |
|
|
(638,212 |
) |
|
|
(44,512 |
) |
|
Loss before
income taxes |
|
|
(5,979,054 |
) |
|
|
(4,027,247 |
) |
|
|
(16,600,250 |
) |
|
|
(13,071,205 |
) |
|
Income tax
benefit (expense) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
|
(5,979,054 |
) |
|
|
(4,027,247 |
) |
|
|
(16,600,250 |
) |
|
|
(13,071,205 |
) |
|
Net loss per
share of common stock, basic and diluted |
|
$ |
(0.30 |
) |
|
$ |
(0.36 |
) |
|
$ |
(1.16 |
) |
|
$ |
(1.16 |
) |
|
|
|
|
|
|
|
|
|
|
|
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-130-1124
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