Cingulate Initiates Final Study for Lead ADHD Asset CTx-1301

Rhea-AI Summary

Cingulate Inc. (NASDAQ: CING) has initiated its final FDA-required study for CTx-1301, a dexmethylphenidate-based treatment for ADHD. The food effect study is expected to yield results by the end of 2024. The company has also raised over $10 million in additional capital since mid-August 2024, with 58% coming from its at-the-market facility. This capital infusion strengthens Cingulate's balance sheet and supports the advancement of CTx-1301 towards NDA submission, targeted for mid-2025. Additionally, Cingulate has received notification from Nasdaq confirming its compliance with listing requirements, addressing previous concerns about potential delisting.

Positive

• Initiated final FDA-required study for CTx-1301, moving closer to NDA submission
• Raised over $10 million in additional capital, strengthening the balance sheet
• Regained compliance with Nasdaq listing requirements

Negative

• None.

Insights

Pharmaceutical Industry Analyst

The initiation of Cingulate's final FDA-required study for CTx-1301 marks a significant milestone in the drug's development journey. This food effect study is important for understanding how the medication interacts with food, which can impact its absorption and efficacy. The expected data readout by end of 2024 positions Cingulate for a potential NDA submission in mid-2025, a critical step towards market entry.

The $10 million capital raise is a positive financial development, strengthening Cingulate's balance sheet and providing runway for CTx-1301's final development stages. With 58% coming from their at-the-market facility, it demonstrates investor confidence in the company's prospects. Regaining Nasdaq compliance is also important for maintaining investor access and credibility in the market.

ADHD Specialist

CTx-1301, a dexmethylphenidate formulation, enters a competitive yet growing ADHD market. The Precision Timed Release™ technology could offer a differentiated product in a field where medication adherence and duration of effect are key concerns. If successful, CTx-1301 might provide more consistent symptom control throughout the day, addressing a significant unmet need in ADHD treatment.

However, it's important to note that the ADHD market is crowded with both branded and generic options. Cingulate will need to demonstrate clear clinical advantages over existing treatments to gain market share. The food effect study is particularly relevant for ADHD medications, as timing of doses relative to meals can impact effectiveness and side effects, potentially offering Cingulate a unique selling point if results are favorable.

Financial Analyst

Cingulate's financial position has improved significantly with the $10 million capital raise. This infusion provides important runway for completing CTx-1301's development and preparing for NDA submission. The company's ability to raise capital, particularly through its at-the-market facility, suggests investor confidence in its prospects.

Regaining Nasdaq compliance is a positive development for Cingulate's market standing and liquidity. However, investors should note that biopharmaceutical companies often require substantial capital through the approval and commercialization phases. While the current funding is encouraging, Cingulate may need additional capital raises before achieving profitability, potentially leading to dilution. The timeline to potential approval in 2025-2026 means investors should be prepared for a medium to long-term investment horizon.

$10 Million of additional Capital Recently Raised Strengthening Balance Sheet

KANSAS CITY, Kan., Sept. 12, 2024 (GLOBE NEWSWIRE) -- 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 commenced its final FDA-required study, which is a food effect study, for CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). A data readout from the study is expected by the end of 2024.

Additionally, Cingulate has raised over $10 million in additional capital since the middle of August 2024, 58% of this amount from its at the market facility, and has received notification from Nasdaq that Cingulate is now in compliance with Nasdaq listing requirements.

“We are pleased to have raised additional substantial capital, which allows us to focus on advancing the final activities required for NDA submission of our lead asset, CTx-1301, which is targeted for mid 2025. Initiating the final study for CTx-1301 is a key milestone moving us one step closer to NDA submission,” said Cingulate Chairman and CEO Shane J. Schaffer.

About the Fast Fed Study
The study is an assessment of the effect of food on the absorption of the highest dose of CTx-1301. An open-label, randomized, single-dose, two-period, two-treatment (Fed vs. Fasted), two-sequence, crossover study In Healthy adult subjects to assess the effect of food on the bioavailability of CTx-1301 (dexmethylphenidate) of the highest dose.

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-1301
Cingulate’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 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.

About Precision Timed Release™ (PTR™) Platform Technology
Cingulate 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 & Public Relations:
Thomas Dalton
Vice President, Investor & Public Relations, Cingulate
tdalton@cingulate.com
(913) 942-2301

Matt Kreps
Darrow Associates
mkreps@darrowir.com
(214) 597-8200

FAQ

What is the latest development for Cingulate's ADHD treatment CTx-1301?

Cingulate has initiated the final FDA-required study, a food effect study, for CTx-1301 (dexmethylphenidate) for the treatment of ADHD. Results are expected by the end of 2024.

How much additional capital has Cingulate (CINGW) raised recently?

Cingulate has raised over $10 million in additional capital since mid-August 2024, with 58% of this amount coming from its at-the-market facility.

When is Cingulate targeting to submit the NDA for CTx-1301?

Cingulate is targeting mid-2025 for the NDA submission of CTx-1301.

Has Cingulate resolved its Nasdaq listing compliance issues?

Yes, Cingulate has received notification from Nasdaq that it is now in compliance with Nasdaq listing requirements.