Precision Time Protocol Industry Profile

Cingulate to Host CNS Key Opinion Leader Panel in New York City

Retrieved on:

Tuesday, October 17, 2023

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The live-streamed event will be held from 10:00am-11:30am EST at the Union League Club in Midtown Manhattan, and will focus on the Company’s leading, late-stage asset CTx-1301(dexmethylphenidate), along with ADHD and anxiety-related disorders.

Key Points:

The live-streamed event will be held from 10:00am-11:30am EST at the Union League Club in Midtown Manhattan, and will focus on the Company’s leading, late-stage asset CTx-1301(dexmethylphenidate), along with ADHD and anxiety-related disorders.
For those in the New York area who would like to attend, there will be space for approximately 25-30 guests in the club’s Grant Room.
Those who wish to watch the event virtually may do so through the link provided here , with the passcode 429018.
“The Cingulate team thanks Dr. Childress and Dr. Mattingly for their participation in this event.

Cingulate Announces Closing of $4.0 Million Public Offering

Retrieved on:

Wednesday, September 13, 2023

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

Key Points:

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
Total gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $4.0 million.
The offering was made only by means of a prospectus forming part of the effective registration statement relating to the offering.
A preliminary prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at http://www.sec.gov .

Cingulate Announces Pricing of $4.0 Million Public Offering

Retrieved on:

Monday, September 11, 2023

The closing of the offering is expected to occur on or about September 13, 2023, subject to the satisfaction of customary closing conditions.

Key Points:

The closing of the offering is expected to occur on or about September 13, 2023, subject to the satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
Total gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $4.0 million.
The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering.

Cingulate Announces Detailed Trial Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (dexmethylphenidate) for ADHD

Retrieved on:

Monday, September 11, 2023

KANSAS CITY, Kan., Sept. 11, 2023 (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 full results from the Phase 3 adult efficacy and safety study of its lead candidate, CTx-1301 (dexmethylphenidate), for the treatment of attention deficit/hyperactivity disorder (ADHD), presented on September 8th at the 36th Annual Psych Congress, in Nashville, TN. A poster describing this data was selected as a finalist for the Psych Congress’s First Annual Poster Awards.

Key Points:

A poster describing this data was selected as a finalist for the Psych Congress’s First Annual Poster Awards.
The Phase 3 CTx-1301-022 study ( NCT05631626 ) assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom setting.
“Along with a restricted duration of efficacy, another limitation of current stimulant-based treatments for ADHD is the phenomena of crash and rebound they produce.
Additionally, CTx-1301 demonstrated a reduction in Adult ADHD Investigator Symptom Rating Scale (AISRS) scores (-16.3).

Cingulate Announces Presentation of Full Trial Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (dexmethylphenidate) for ADHD at Psych Congress 2023

Retrieved on:

Tuesday, September 5, 2023

The poster was accepted as a finalist for the first annual Psych Congress Poster Awards, which will be awarded onsite at the conference.

Key Points:

The poster was accepted as a finalist for the first annual Psych Congress Poster Awards, which will be awarded onsite at the conference.
The data demonstrated a trend towards significance in improving ADHD symptoms with a rapid onset of action and entire active-day duration.
In addition to the Phase 3 adult dose-optimization study, Cingulate initiated its pivotal Phase 3 fixed-dose pediatric and adolescent study in July 2023, as well as a dose-optimization onset and duration study in pediatric patients in August 2023.
Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in the second half of 2024 under the Section 505(b)(2) pathway.

Cingulate Inc. Reports Second Quarter 2023 Financial Results and Provides Clinical and Business Update

Retrieved on:

Monday, August 14, 2023

KANSAS CITY, Kan., Aug. 14, 2023 (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 provided financial results for the quarter ended June 30, 2023, as well as a clinical and business update. Among other highlights, the Company announced a $1 million dollar investment from Werth Family Investment Associates LLC (WFIA), top-line results following the completion of a Phase 3 Adult Efficacy and Safety Trial of CTx-1301, and the initiation of the CTx-1301 Phase 3 pediatric and adolescent studies.

Key Points:

CTx-1301: Cingulate advanced its clinical program for CTx-1301 on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
As part of that effort:
Cingulate completed a Phase 3 adult dose-optimization study in June 2023 and announced top-line results in July 2023.
Assuming positive clinical results from the upcoming Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in the second half of 2024 under the Section 505(b)(2) pathway.
Cingulate expects its cash and cash equivalents will enable the Company to fund its research and development and operating expenditures into September 2023.

Cingulate Announces Positive Top-Line Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (dexmethylphenidate) for ADHD

Retrieved on:

Tuesday, July 11, 2023

Although a secondary endpoint, the established CGI scale for severity of illness demonstrated clinical improvement in severity of illness.

Key Points:

Although a secondary endpoint, the established CGI scale for severity of illness demonstrated clinical improvement in severity of illness.
After a 5-week dose optimization period, subjects were either randomized to their optimized dose of CTx-1301 or placebo.
In addition to the Phase 3 adult dose-optimization study, Cingulate plans to initiate its pivotal Phase 3 fixed-dose pediatric and adolescent study this month and a dose-optimization onset and duration trial in pediatric patients in August 2023.
Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.

Cingulate Successfully Manufactures Clinical Supply – Initiation of Pediatric Phase 3 Studies to Commence in July and August

Retrieved on:

Thursday, June 29, 2023

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All doses of CTx-1301 are now available for both pivotal Phase 3 pediatric and adolescent clinical trials, with the fixed-dose study scheduled to begin the week of July 24.

Key Points:

All doses of CTx-1301 are now available for both pivotal Phase 3 pediatric and adolescent clinical trials, with the fixed-dose study scheduled to begin the week of July 24.
“We have effectively collaborated with our manufacturing partner, Societal CDMO, to successfully manufacture all doses required to initiate our pivotal Phase 3 pediatric and adolescent clinical program, and we look forward to the initiation of the fixed-dose study,” said Laurie A. Myers, PhD, Chief Operating Officer, Cingulate.
Cingulate recently completed a Phase 3 adult onset and duration study of CTx-1301 with results expected 3Q 2023.
Assuming positive clinical results from its Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.

Cingulate Completes Phase 3 Adult Trial of CTx-1301 (dexmethylphenidate) for ADHD

Retrieved on:

Thursday, June 8, 2023

KANSAS CITY, Kan., June 08, 2023 (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 it has completed its Phase 3 adult dose-optimization trial of its lead candidate, CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity disorder (ADHD), upon approval from the U.S. Food and Drug Administration (FDA).

Key Points:

The Phase 3 CTx-1301-022 study ( NCT05631626 ) assessed the onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom setting.
Results from the trial are expected in 3Q 2023 and will be submitted for presentation at a future medical meeting.
In addition to the Phase 3 adult dose-optimization study, Cingulate plans to initiate its pivotal Phase 3 fixed-dose pediatric and adolescent study and its pivotal dose-optimization onset and duration trial in pediatric patients in 3Q 2023.
Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.

Cingulate to Present at 13th Annual LD Micro Invitational

Retrieved on:

Thursday, May 25, 2023

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The event is expected to feature 150+ companies, presenting in half-hour increments, as well as private one-on-one meetings.

Key Points:

The event is expected to feature 150+ companies, presenting in half-hour increments, as well as private one-on-one meetings.
Cingulate Chairman & CEO Shane J. Schaffer is scheduled to present a company overview on June 6th at 9:30 a.m. PST.
In addition to the Company’s initial focus on the $22bn ADHD market, Cingulate is identifying other indications, such as anxiety, where it’s PTR™ technology may be effectively utilized.
To arrange a meeting with Cingulate, please contact your LD Micro representative, or Cingulate investor relations at [email protected] .