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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 StudyThe 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-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 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 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 & Public Relations:Thomas DaltonVice President, Investor & Public Relations, Cingulatetdalton@cingulate.com(913) 942-2301
Matt KrepsDarrow Associatesmkreps@darrowir.com(214) 597-8200
Cingulate Inc. C shares are soaring Friday.
Last week, the company announced a Precision Timed Release (PTR) technology, designed to enhance ADHD drug delivery. The company’s technology aims to improve the onset and efficacy of existing ADHD treatments. Zacks Small-Cap Research also issued a note with a $70 valuation on the stock earlier this week.
Trading Volume: The stock opened at $6.63 and has traded within a day range of $6.01 to $9.69. The 50-day moving average stands at $5.81. Cingulate’s short interest has decreased by 75.73% since its last report, now at 51,000 shares, which is 3.18% of its float.
Key Metrics Recap:
How To Buy CING Stock?
Buying shares is typically done through a brokerage account. You can find a list of possible trading platforms here. Many will allow you to buy ‘fractional shares,' which allows you to own portions of stock without buying an entire share. For example, some stock, like Berkshire Hathaway, or Amazon.com, can cost thousands of dollars to own just one share. However, if you only want to invest a fraction of that, brokerages will allow you to do so.
In the the case of Cingulate C, which is trading at $8.2 as of publishing time, $100 would buy you 12.2 shares of stock.
If you're looking to bet against a company, the process is more complex. You'll need access to an options trading platform, or a broker who will allow you to ‘go short' a share of stock by lending you the shares to sell. The process of shorting a stock can be found at this resource. Otherwise, if your broker allows you to trade options, you can either buy a put option, or sell a call option at a strike price above where shares are currently trading – either way it allows you to profit off of the share price decline.
CING Price Action: Cingulate shares were up by 15% at $7.42 according to Benzinga pro.
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© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
KANSAS CITY, Kan., Aug. 27, 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, today announced that Chairman and CEO Shane J. Schaffer, PharmD, will participate in a live Benzinga All Access event on August 28, 2024, at 10:30 a.m. CST.
Along with a company overview, Dr. Schaffer will discuss Cingulate’s recently issued European patent, the state of the ADHD marketplace, as well as the potential expansion of Cingulate’s PTR platform into other therapeutic areas.
The event may be viewed live on Benzinga’s YouTube channel, Benzinga All Access, and will also be available for viewing on Cingulate’s website at cingulate.com/investors
About Cingulate®Cingulate Inc. (NASDAQ: CING), 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 PTR technology may be employed to develop future product candidates, including to treat anxiety disorders.Cingulate is headquartered in Kansas City. For more informationvisit Cingulate.com
Investor RelationsThomas DaltonHead of Investor & Public Relations, CingulateTDalton@cingulate.com913-942-2301
Matt KrepsDarrow Associatesmkreps@darrowir.com214-597-8200
Aug 23 (Reuters) - Cingulate Inc CING.O:
CINGULATE ANNOUNCES ADJOURNMENT OF SPECIAL MEETING
Source text for Eikon: (Full Story)
Further company coverage: CING.O
KANSAS CITY, Kan., Aug. 23, 2024 (GLOBE NEWSWIRE) -- 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 announced that it has adjourned its Special Meeting of Stockholders (the “Special Meeting”) in order to provide stockholders additional time within which to vote on all proposals.
At this time, there are not present, by remote communication or by proxy, a sufficient number of shares of the Company’s common stock to constitute a quorum. The Company’s Board of Directors continues to believe that that all of the proposals contained in the proxy statement are advisable and in the best interests of the Company’s stockholders to consider and act upon. Therefore, the Company adjourned the Special Meeting.
The adjourned meeting will be held at 11:00 a.m. Central Time on August 28, 2024, at the following url: www.meetnow.global/MCZZ4DG. The record date for the Special Meeting is June 28, 2024.
Special Meeting of Stockholders of Cingulate Inc.
The adjourned meeting will be held at 11:00 a.m. Central Time on August 28, 2024, at the following url: www.meetnow.global/MCZZ4DG. The Board of Directors unanimously recommends that stockholders vote FOR all proposals on the agenda.
Stockholders may cast their vote live by calling toll free at 1-800-652-8683 or online by going to www.envisionreports.com/CING-SP.
About Cingulate®
Cingulate Inc. (NASDAQ: CING), 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 PTR technology may be employed to develop future product candidates, including to treat anxiety disorders.
Cingulate is headquartered in Kansas City.
Investor RelationsThomas DaltonVice President, Investor & Public Relations, CingulateTDalton@cingulate.com913-942-2301
Matt KrepsDarrow Associatesmkreps@darrowir.com214-597-8200
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