Cingulate Inc (CING) News

CING new 52 week low

Real quiet here

Sorry wrong board

News out

Miax needs to cover. Let’s hit the ask. Make them chase

Ok dick! I do my own ... but your continued comments never have any reference to them so it appears your research is misleading or BS.

Do ur own research brah

Based off what source? And when will this come out in the news?

New partner on deck. Just waiting. This is their opportunity to impress the stock price

Huh?

Regained NAZ compliance

.76 fills thanks mms

Mm buying 100 lots they need shares looks like !

Company Is Seeking Licensing Partners News Watch->

“”We also believe this communication provides additional go-to-market momentum as we continue to meet with potential partners for the outlicensing of CTx-1301 in the United States and abroad.””






FDA Clears Cingulate to File for Marketing Approval of CTx-1301 in the Treatment of ADHD

Source: GlobeNewswire Inc.

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 that it has received confirmation from and is aligned with the U.S. Food and Drug Administration (FDA) on the requirements necessary for filing a New Drug Application (NDA) for its lead Phase 3 candidate CTx-1301 (dexmethylphenidate), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age or older.
Details from the FDA communication to Cingulate include the following:

Per the 505(b)(2) pathway, submission of CTx-1301’s NDA does not require continuation of the fixed dose study and the onset and duration study;
Data collected to date from these two Phase 3 studies will be included in the filing; and
Contemporaneously with the preparation of the NDA filing, Cingulate will conduct a Phase 1 fed/fast study, the study is expected to last approximately two to three weeks, with the results being included in the NDA filing.
“We are pleased with the FDA’s guidance and perspective regarding our pathway to a timely NDA filing, and we will proceed to complete all remaining requirements accordingly,” said Cingulate Chairman and CEO Shane J. Schaffer. “We also believe this communication provides additional go-to-market momentum as we continue to meet with potential partners for the outlicensing of CTx-1301 in the United States and abroad. Now that we have a clear path to submission, we look forward to engaging with key payer stakeholders to achieve maximum access and market penetration to benefit ADHD patients and their families.”

Cingulate has begun NDA preparation and expects to submit its filing in the first half of 2025.

Ann Childress, M.D., President, Center for Psychiatry and Behavior Medicine, Inc., and lead investigator of Cingulate’s CTx-1301 onset and duration study, stated, “The treatment effect size of CTx-1301 was remarkable given the current effect sizes observed in the marketplace. Many patients require longer duration of efficacy and must add a second, or booster, dose to ensure treatment effect over their entire active day. The patients I observed, once notified they were taking CTx-1301, have expressed a desire to remain on the medication after the trial concluded.”

“If approved,” Childress continued, “I believe CTx-1301 could potentially benefit the more than 60 percent of patients currently using immediate-release booster doses to extend the efficacy of their medications.”

Earlier this year, Cingulate presented results from the Phase 3 adult efficacy and safety study of CTx-1301 at the 2024 American Professional Society of ADHD and Related Disorders (APSARD) conference in Orlando, FL.

The results were previously presented at the 2023 Psych Congress, where a poster describing the data was selected as a finalist for the Psych Congress’s First Annual Poster Awards.

The Cingulate poster presented at APSARD provided additional insight regarding CTx-1301’s ADHD leading effect size. Effect size conveys clinical significance rather than statistical significance, is not reliant on sample size, and allows for comparison across trials. The poster presented may be viewed here.

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®
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. 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 April 1, 2024. 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 Dalton
Vice President, Investor & Public Relations, Cingulate
TDalton@cingulate.com
913-942-2301

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

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/00c8b334-57ec-49cf-9a59-02d75463089e

Every buy is about :26 seconds to “quietly accumulate”. MIAX buying. L3 on my BB terminal

Gonna pop.

MIAX is long.

Yah, by whom? Who tells u these things?

HC Wainwright will up their target with additional analyst coverage I’m told

Next up. Partnership pipeline.

We are MM. powwww

We break .8380 and off we go. The sales were planned between lake from the s-1. We have almost traded the entire float (6.57m); if they even sold the additional 2m shares. I doubt it but this am was possible. Someone accumulated all of it. Double down here.

My avg is a bit higher, bit ok to hold. Slowly it will start crawling up..imo??

We are buying

Seems like sell on news today??

This is a double digit stock. Minimum $8

Angel investor going to enfuse.

Locked and not selling. This will be more than an ADHD company. Think 5-10 out of

News on deck from Vegas and FDA submission

Cash infusion, Tender Offer or private placement with either BDD or Chemwerth Inc.

Volume up too

Nice buys coming in.

Last time you will see cents and single dollars.

CING back over $1.00. Starting to form a base.

Broke outside top KG band. Reversal definitely showing here. Load it up

Definitive agreement should be announced Friday showing $5-10m cash infusion and ramp up on clinical.

Gonna break $2 on expected cash flow. $30 stock easy

Pending definitive agreement will be inked. $5-$10m which will cover the NDA fees of roughly $3.6m. Back that into the S/P makes it an $8 stock alone hence why HC wainwright has an estimate at $8. Couldn’t be easier

233 shareholder as of 12/2023 and 1.167M shares. This thing is a 30-50x based on NDA filing. This is a gem.

Gobble up. Buy stops sitting at $1.02.

Funding of $5-10m in deck

Loading all over here

Well not the sexiest news but….

The last flush. Expect PR tomorrow

Shayne says expect the update. Have your buy stops in.

Look at the conversion of warrants. $2 and 2.50. MM will peg higher

One additional strategic partnership, and this thing is a $10 stock overnight

Mispriced market. Period. Load it

I will take 10%of a $22b market especially future cash flows. The market will price that in. 3.9m/$2b. You do the math. It’s easily 200x from here

Current Status
• Ex-US
o Major UK pharma company is in final stages to execute UK agreement; $5M potential
with additional $5-10M with additional EU territories
o EU/Middle East/Latin America pharma company nearing term sheet exchange
o Brazilian pharma company nearing term sheet exchange
• US
o Commercialization agreement executed with Indegene for full service Go-To-Market
and Launch execution
o Term sheet imminent with US based company for 50/50 copromote partnership