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, announced today that it has appointed
three new directors to its board: Jay Roberts, Bryan Lawrence, and
Jeff Ervin.
The appointment of the new directors follows the completion of
the Company’s recent follow-on offering of $7.5 million in February
2024, sales under the Company’s at-the-market offering (ATM)
facility in January 2024 of $3.2 million, as well as the conversion
of $3.3 million of outstanding debt into equity at a 10 percent
premium to market.
“We always look forward to adding directors who complement our
management team, mission and overall vision, and we are pleased to
welcome Jay, Bryan and Jeff to our board,” said Cingulate Chairman
and CEO Shane J. Schaffer. “We believe their collective experience
in business, public markets, finance, healthcare and
pharmaceuticals will be instrumental to the Company as we move
forward with our clinical trials and business opportunities.”
About the Directors
Jay RobertsJay Roberts has been a senior
strategic executive in the healthcare industry for over 30 years.
He is serving as a Venture Partner for DigiLife Fund II, leading
fundraising, due diligence, and investment decisions along with
members of the DigiLife team and syndicate investment funds. He
currently serves as a member of the Board of Directors for Caidya,
Inc.; Veriskin, Inc.; NaviPoint Health, Inc.; Vyant Bio, Inc. and
is a member of the Fellows of DIA.
Jay has held CEO, COO, and CFO positions for publicly traded and
venture and private equity backed healthcare technology,
diagnostics, software solutions and manufacturing companies
throughout a successful industry career.
Bryan LawrenceBryan Lawrence has nearly 25
years of experience in the pharmaceutical and healthcare
industries, serving in a variety of research-based capacities in
Pharmacoeconomics and Managed Care Outcomes Research departments at
Novartis (formerly Sandoz) and Janssen Pharmaceutica (J&J), as
well as some diverse commercial roles.
Bryan served as Director, Managed Care Marketing, and was a
member of the Aciphex® Launch Team at Janssen. He was also
responsible for contracting efforts with United Healthcare for nine
Johnson & Johnson operating companies as a Corporate Account
Director at Johnson & Johnson Health Care Systems.
Dr. Lawrence has significant experience in healthcare consulting
and has held roles at Navigant Consulting and Applied Health
Outcomes, and was one of four owners/partners who rebranded Applied
Health Outcomes as Xcenda, a diverse consulting company that worked
with pharmaceutical industry clients. Dr. Lawrence was serving as
Xcenda’s Vice President, Marketing and Business Development, when
Xcenda was acquired by AmerisourceBergen Corporation.
Bryan holds a Doctor of Pharmacy degree from the University of
Kansas, a two-year Pharmacoeconomics Fellowship from Glaxo Inc. and
the University of South Carolina, and an MBA from the Wharton
School at the University of Pennsylvania. He is also a member of
the University of Kansas School of Pharmacy Advisory Council.
Jeff ErvinJeff Ervin has more than 20 years of
experience as an executive and investor in high growth businesses.
Mr. Ervin has held the position of Chairman and CEO of IMAC
Holdings (NASDAQ: BACK) since 2015.
Prior to IMAC, Mr. Ervin served as senior financial officer
for Medicare.com and its parent company Medx Publishing.
He launched his post-MBA career as Senior Financial Analyst for the
Baptist Hospital System of Nashville where he was responsible for
evaluating direct equity placement and managing portfolio
investments in healthcare.
Mr. Ervin holds an MBA from the Owen School of Management at
Vanderbilt University and a Bachelor of Science in Finance from
Miami University.
About Attention Deficit/Hyperactivity Disorder
(ADHD)ADHD is a chronic neurobiological and developmental
disorder that affects millions of children and often continues into
adulthood. The condition is marked by an ongoing pattern of
inattention and/or hyperactivity-impulsivity that interferes with
functioning or development. In the U.S., approximately 6.4 million
children and adolescents (11 percent) aged under the age of 18 have
been diagnosed with ADHD. Among this group, approximately 80
percent receive treatment, with 65-90 percent demonstrating
clinical ADHD symptoms that persist into adulthood. Adult ADHD
prevalence is estimated at approximately 11 million patients (4.4
percent), almost double the size of the child and adolescent
segment combined, however, only an estimated 20 percent receive
treatment.
About CTx-1301Cingulate’s lead candidate,
CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery
platform to create a breakthrough, multi-core formulation of the
active pharmaceutical ingredient dexmethylphenidate, a compound
approved by the FDA for the treatment of ADHD. Dexmethylphenidate
is part of the stimulant class of medicines and increases
norepinephrine and dopamine activity in the brain to affect
attention and behavior.
While stimulants are the gold-standard of ADHD treatment due to
their efficacy and safety, the long-standing challenge continues to
be providing patients entire active-day duration of action.
CTx-1301 is designed to precisely deliver three releases of
medication at the predefined time, ratio, and style of release to
optimize patient care in one tablet. The result is a rapid onset
and entire active-day efficacy, with the third dose being released
around the time when other extended-release stimulant products
begin to wear off.
About Precision Timed Release™ (PTR™) Platform
TechnologyCingulate is developing ADHD and anxiety
disorder product candidates capable of achieving true once-daily
dosing using Cingulate’s innovative PTR drug delivery platform
technology. It incorporates a proprietary Erosion Barrier Layer
(EBL) providing control of drug release at precise, pre-defined
times with no release of drug prior to the intended release. The
EBL technology is enrobed around a drug-containing core to give a
tablet-in-tablet dose form. It is designed to erode at a controlled
rate until eventually the drug is released from the core tablet.
The EBL formulation, Oralogik™, is licensed from BDD Pharma.
Cingulate intends to utilize its PTR technology to expand and
augment its clinical-stage pipeline by identifying and developing
additional product candidates in other therapeutic areas in
addition to Anxiety and ADHD where one or more active
pharmaceutical ingredients need to be delivered several times a day
at specific, predefined time intervals and released in a manner
that would offer significant improvement over existing therapies.
To see Cingulate’s PTR Platform
click here.
About Cingulate Inc.Cingulate Inc. (NASDAQ:
CING), is a biopharmaceutical company utilizing its proprietary 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 ADHD,
Cingulate is identifying and evaluating additional therapeutic
areas where PTR technology may be employed to develop future
product candidates, including to treat anxiety disorders. Cingulate
is headquartered in Kansas City. 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.
Investor Relations:Thomas DaltonVice President,
Investor & Public Relations,
Cingulatetdalton@cingulate.com(913) 942-2301
Matt KrepsDarrow
Associatesmkreps@darrowir.com(214) 597-8200
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