Cingulate Inc. (NASDAQ: CING), a clinical-stage 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 June 30, 2022, and provided
a clinical and business update. Highlights include the announcement
of $5 million of debt financing and the appointment of an
additional member to Cingulate’s Board of Directors.
“Cingulate continues to advance its mission in
bringing next-generation medications to patients where
standard-of-care treatments result in suboptimal outcomes. Millions
of patients today who suffer from Attention Deficit/Hyperactivity
Disorder (ADHD) and anxiety could benefit from the true once-daily
medications we are advancing now,” said Shane J. Schaffer,
Cingulate Chairman & CEO.
Schaffer continued, “Capital is imperative to
any clinical-stage company’s long-term success, so we’re pleased to
announce that we strengthened our balance sheet through a
non-dilutive transaction with board member and long-standing
investor, Peter J. Werth. This additional financing exemplifies
Werth’s confidence in Cingulate’s pipeline and overall mission.
Furthermore, as we move toward our new drug application (NDA)
filings, the appointment of Scott Applebaum to our board brings
over 10 years of ADHD expertise and adds to the pharmaceutical
industry hallmarks that comprise our board.”
Werth Family Investment Associates
Provides $5 Million of Debt Financing
Cingulate received $5 million of debt financing
from Werth Family Investment Associates LLC (WFIA). The promissory
note executed in favor of WFIA is unsecured with interest accruing
at 15% per annum. Outstanding principal and interest is due and
payable on August 8, 2025, and WFIA has a right during the first
five business days of each calendar quarter beginning April 1, 2023
to call for payment 120 days after notice to the Company. WFIA owns
871,731 shares of Cingulate common stock and Peter J. Werth, a
member of Cingulate’s Board of Directors and the manager of WFIA,
owns 21,849 shares of Cingulate common stock.
Scott Applebaum Appointed to Cingulate
Board of Directors
Cingulate has expanded its Board of Directors to
eight directors and appointed Scott Applebaum as a Class III
director. Mr. Applebaum is an industry veteran with over 25 years
of experience at large and small biopharmaceuticals companies. He
is currently Chief Legal Officer and Corporate Secretary at
VectivBio (NASDAQ:VECT), a biopharmaceutical company focused on the
discovery, development, and commercialization of innovative
treatments for severe rare conditions with high unmet medical
need.
Mr. Applebaum brings considerable ADHD expertise
to Cingulate having spent a decade at Shire, now Takeda. At Shire
he worked in various roles critical to the success of its
blockbuster ADHD franchises (Adderall XR®, Vyvanse® and Intuniv®),
including leading its global legal, regulatory and commercial
functions at various points in his 10-year tenure.
Prior to his current position at VectivBio,
Applebaum was the Chief Legal & Compliance Officer and Senior
Vice President of Regulatory Affairs at Trevena, where he played a
key role in gaining U.S. Food and Drug Administration (FDA)
approval for their lead product, Olinvyk®. Previously, he served as
President of Context Therapeutics and was General Counsel at Vitae
Pharmaceuticals, where he was instrumental in their sale to
Allergan. Formerly, he was Chief Legal Officer for Medgenics, a
rare genetic disease company, and he began his pharmaceuticals
career at Bristol Myers Squibb.
“Cingulate is creating next-generation products
to address the long-standing unmet needs of patients with ADHD.
Having spent a decade involved in ADHD and working closely with the
ADHD community, I have seen first-hand the need for these
innovative products. I am excited to join the Cingulate Board of
Directors to support the growth of this company, its product
candidates, and drug pipeline – all of which are on a promising
trajectory and have the potential to make a real difference for
patients,” Mr. Applebaum said.
Before entering the biopharmaceutical industry,
Applebaum was a lawyer at Dechert LLP. He received his J.D. from
Stanford Law School and a B.S. in Economics, Finance and Accounting
from the Wharton School of the University of Pennsylvania.
Clinical and Business
Update
- CTx-1301:
Cingulate has designed its clinical program for CTx-1301
(dexmethylphenidate), its lead investigational asset for the
treatment of ADHD, based on FDA feedback regarding its CTx-1301
initial Pediatric Study Plan (iPSP), and longstanding guidance on
the expedited approval pathway under Section 505(b)(2) of the
Federal Food, Drug, and Cosmetic Act.The Company has commenced
study start-up activities for the CTx-1301 Phase 3, fixed-dose,
pediatric and adolescent safety and efficacy study, and anticipates
dosing the first patient in late 2022. Cingulate has been
experiencing delays in the manufacturing and delivery of clinical
supply for this study due to operational resource issues at its
contract manufacturing organization. Manufacturing of the final two
dosage strengths, which are necessary to dose the first patient, is
expected to begin in the second half of this year. Results from the
fixed-dose study are expected in the second half of 2023. In order
to meet the pharmacology requirement for the CTx-1301 NDA
submission, Cingulate plans to complete a food effect study in the
fourth quarter of 2022. Assuming it receives positive clinical
results from the Phase 3 trial and food effect study, Cingulate
still plans to submit the NDA for CTx-1301 in late 2023 under the
Section 505(b)(2) pathway.In addition to the studies noted above,
Cingulate plans to initiate an adult dose-optimization study (Phase
3b) to assess the onset and duration of efficacy in the second half
of 2023. This Phase 3b trial is supplementary and is not required
for the CTx-1301 NDA submission.In order to achieve the filing of
the NDA for CTx-1301 in late 2023 for potential FDA approval,
Cingulate believes that it will need approximately $16.5 million of
additional capital. Cingulate will also need additional capital to
advance its other programs. The Company is evaluating alternatives
to raise additional capital, including equity and debt financing
and non-dilutive strategic collaborations in the U.S. and abroad.
In addition, Cingulate continues to evaluate commercial
collaborations, which would provide more immediate access to
marketing, sales, market access and distribution
infrastructure.
-
CTx-1302: Cingulate plans to initiate a Phase
1/2 bioavailability study in ADHD patients for CTx-1302
(dextroamphetamine), its second investigational asset for the
treatment of ADHD, in 2023 and, if the results from this study are
successful, the Company plans to initiate pivotal Phase 3 clinical
trials in all patient segments for CTx-1302 in 2024 with results
expected in 2025.
- CTx-2103:
Cingulate announced in June the completion of the human formulation
study for its third asset, CTx-2103, for the management of anxiety,
which is the most common mental health concern in the U.S.
Furthermore, this trial extends the potential of the PTR platform
where multiple daily doses are required and the timing, style, and
ratio of this medication delivery is paramount. The study was
conducted at BDD Pharma in the United Kingdom. Results are expected
later this month.CTx-2103 contains the active pharmaceutical
ingredient buspirone hydrochloride, a non-benzodiazepine
medication, which has no evidence for the development or risk of
dependency. However, due to its short half-life, buspirone is
prescribed to be taken several times a day for management of
anxiety, which can be challenging for patients and may lead to
sub-optimal treatment outcomes. CTx-2103 will be designed as a
once-daily, multi-dose tablet, which the Company believes will
offer clear differentiation and compelling advantages over
currently available treatment options.
Second Quarter Results
- Cash Position: As
of June 30, 2022, Cingulate had $8.2 million in cash and cash
equivalents, as compared to $16.5 million in cash and cash
equivalents as of December 31, 2021. Cash and cash equivalents as
of June 30, 2022, reflect the net proceeds of the Company’s IPO of
approximately $20.4 million, which closed on December 10, 2021,
less development and operating expenses which occurred in late 2021
and the first two quarters of 2022. 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 general and
administrative expenditures through the first quarter of 2023.
- Research & Development
(R&D) Expenses: R&D expenses were $2.2 million for
the three months ended June 30, 2022, compared to $0.8 million for
the same period in 2021. R&D expenses were $4.9 million for the
six months ended June 30, 2022, as compared to $1.4 million for the
same period in 2021. Development activity has been increasing since
late 2021 as the Company is active in study start-up phase of a
Phase 3 clinical study, the fixed-dose pediatric and adolescent
safety and efficacy study for CTx-1301. In addition, manufacturing
of the Phase 3 clinical supply for this study began in the first
quarter of 2022 with continued activity in the second quarter of
2022. The Company has also incurred costs in the first two quarters
of 2022 relating to a human formulation study for CTx-2103.
- General and Administrative
(G&A) Expenses: G&A expenses were $1.9 million for
the three months ended June 30, 2022, compared to $0.6 million for
the same period in 2021. G&A expenses were $4.1 million for the
six months ended June 30, 2022, as compared to $1.4 million for the
same period in 2021. These increases relate to 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 June 30, 2022, compared
to $1.4 million for the same period in 2021. Net loss was $9.0
million for the six months ended June 30, 2022, as compared to $2.8
million for the same period in 2021. These increases relate to the
increased development activity as well as the increase in G&A
expenses relating to additional costs to operate as a public
company, both described above.
About Cingulate®
Cingulate Inc. is a clinical-stage
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.
|
Cingulate Inc. |
Consolidated Balance Sheet Data |
|
|
|
June 30, |
|
December 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Cash, cash equivalents and
short-term investments |
|
$ |
8,195,760 |
|
|
$ |
16,493,678 |
|
Working capital |
|
$ |
9,178,648 |
|
|
$ |
17,705,601 |
|
Total assets |
|
$ |
13,803,855 |
|
|
$ |
22,886,257 |
|
Total liabilities |
|
$ |
1,618,980 |
|
|
$ |
2,042,715 |
|
Accumulated deficit |
|
$ |
(60,776,222 |
) |
|
$ |
(51,732,264 |
) |
Total stockholders'
equity |
|
$ |
12,184,875 |
|
|
$ |
20,843,542 |
|
Cingulate Inc. |
Consolidated Statements of Operations |
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
2,178,226 |
|
|
$ |
793,587 |
|
|
$ |
4,940,510 |
|
|
$ |
1,356,106 |
|
General and administrative |
|
|
1,870,591 |
|
|
|
629,032 |
|
|
|
4,117,651 |
|
|
|
1,396,677 |
|
Operating loss |
|
|
(4,048,817 |
) |
|
|
(1,422,619 |
) |
|
|
(9,058,161 |
) |
|
|
(2,752,783 |
) |
|
|
|
|
|
|
|
|
|
Interest and other income (expense), net |
|
|
8,370 |
|
|
|
(9,676 |
) |
|
|
14,203 |
|
|
|
(13,435 |
) |
Loss before income taxes |
|
|
(4,040,447 |
) |
|
|
(1,432,295 |
) |
|
|
(9,043,958 |
) |
|
|
(2,766,218 |
) |
Income tax benefit (expense) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(4,040,447 |
) |
|
|
(1,432,295 |
) |
|
|
(9,043,958 |
) |
|
|
(2,766,218 |
) |
Net loss per share of common stock, basic and diluted |
|
$ |
(0.36 |
) |
|
|
- |
|
|
$ |
(0.80 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Investor RelationsThomas DaltonHead of 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
Cingulate (NASDAQ:CING)
Historical Stock Chart
From Jun 2024 to Jul 2024
Cingulate (NASDAQ:CING)
Historical Stock Chart
From Jul 2023 to Jul 2024