Full Press Release Details
Inc. Reports Full Year 2024, Fourth Quarter Results, and Provides Development Update on Major Milestones Achieved
FDA Meeting Scheduled for April 2; New Drug Application Submission Targeted for Mid-2025
million increase in Working Capital; Cash Runway Extending into Q4, Well Beyond Target Date for NDA Submission
CITY, Kan., March 26, 2025 - 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 twelve months ended December 31, 2024, and provided a clinical and business update. Highlights
include the announcement of safety results from Cingulate's final Phase 3 trials for lead ADHD asset CTx-1301 (dexmethylphenidate),
and confirmation of a scheduled in-person Pre-NDA meeting with the FDA.
capital raised over the past year has allowed us to strengthen our balance sheet and complete all required clinical trials for NDA submission
for CTx-1301. We look forward to meeting with the FDA next week, submitting our new drug application this summer, and, assuming approval
by the FDA, bringing to market the first, true, once-daily stimulant medication to treat ADHD over the entire active day," said
Cingulate Chairman and CEO Shane J Schaffer.
ASSET CTx-1301 HIGHLIGHTS
YEAR AND FOURTH QUARTER RESULTS
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash and cash equivalents | $ | 12,211,321 | $ | 52,416 | ||||
| Total assets | $ | 14,864,489 | $ | 3,491,436 | ||||
| Working Capital | $ | 7,539,938 | $ | (9,647,172 | ) | |||
| Total liabilities | $ | 7,408,984 | $ | 10,360,865 | ||||
| Accumulated deficit | $ | (108,489,180 | ) | $ | (92,943,443 | ) | ||
| Total stockholders' equity | $ | 7,455,504 | $ | (6,869,429 | ) |
Statements of Operations
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | . | |||||||||||||||
| Research and development | $ | 4,328,683 | $ | 4,984,909 | $ | 9,445,265 | $ | 15,493,304 | ||||||||
| General and administrative | 1,879,806 | 1,812,242 | 6,199,708 | 7,265,885 | ||||||||||||
| Operating loss | (6,208,489 | ) | (6,797,151 | ) | (15,644,973 | ) | (22,759,189 | ) | ||||||||
| Interest and other income (expense), net | 76,510 | (137,546 | ) | 99,236 | (775,758 | ) | ||||||||||
| Loss before income taxes | (6,131,979 | ) | (6,934,697 | ) | (15,545,737 | ) | (23,534,947 | ) | ||||||||
| Income tax benefit (expense) | - | - | - | - | ||||||||||||
| Net loss | $ | (6,131,979 | ) | $ | (6,934,697 | ) | $ | (15,545,737 | ) | $ | (23,534,947 | ) |
Attention Deficit/Hyperactivity Disorder (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., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the
age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported
they were actively treating their symptoms with medication in 2022, with 65-90 percent demonstrating clinical ADHD symptoms that persist
into adulthood. Current market trends demonstrate, that adult ADHD prevalence is larger and growing faster than the child and adolescent
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 with an 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.
Precision Timed Release (PTR ) Platform Technology
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.
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.
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
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studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities
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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 April 1, 2024 and our other filings with the SEC. 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.
President, Investor & Public Relations, Cingulate