Press Release

Go-to-Market Solution Provides Full Commercial Support for the First, True Entire Active-Day Medication Designed to treat ADHD

Indegene Model Geared for Efficient National Commercial Launch in Multibillion-Dollar ADHD Market

KANSAS CITY, Kan. and PRINCETON, N.J., March 13, 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, and Indegene, a digital-first, life sciences commercialization company, today announced a joint commercialization agreement to provide commercial support for Cingulate’s 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).

The agreement spans cross-functional services through an omnichannel marketing approach uniquely designed to successfully manage pre-commercial support during Cingulate’s Phase 3 clinical trials and to effectively commercialize CTx-1301 nationwide following potential FDA approval. Cingulate recently announced the initiation of its first Phase 3 trial for CTx-1301, an adult dose-optimization efficacy and safety study to assess onset and duration, with results expected in the third quarter of 2023. In addition, the Company plans to initiate its pivotal Phase 3 trial, a fixed-dose, placebo-controlled study in pediatric and adolescent patients with ADHD, in mid-2023.

“This agreement provides a clear path to commercialize CTx-1301, upon FDA approval, designed specifically to tackle the unmet needs of this $20 billion market by providing the first true, entire-active-day treatment for ADHD. But the clinical success of a potential treatment can only be realized with commercial excellence, making this partnership between Cingulate and Indegene a critical step for our Company,” said Shane J Schaffer, Chairman and CEO, Cingulate. “We believe Indegene provides a comprehensive solution combining sales professionals and field medical personnel, and its AI-driven omnichannel marketing suite is unparrellled in the industry, making them the right partner at the right time to help Cingulate redefine the ADHD treatment paradigm. Additionally, this allows Cingulate to focus on clinical development by reducing the internal resources and risks associated with building out these functional areas.”

Cingulate’s comprehensive agreement with Indegene covers most facets of the commercialization process, including sales, PRMA (pricing, reimbursement and market access), medical affairs, medical communications, pharmacovigilance, regulatory, marketing and commercial operations support. The partnership is focused on driving revenue and is designed to ensure predictable cash outflow and continues through three years post-launch of CTx-1301.

“We believe the unique attributes of CTx-1301 differentiate Cingulate’s product from other available products in the market, which aligns well to Indegene’s omnichannel approach to raising awareness among physicians and patients,” said Timothy Moore, Senior Vice President of Emerging Biotech at Indegene.

Data show that Indegene’s omnichannel marketing solution has a greater impact than field sales representatives alone, with better customer experiences at a fraction of the cost of the more traditional model. Utilizing proprietary artificial intelligence (AI) and data to reach health care professional (HCP) targets in the most effective and efficient manner, Indegene leverages a large database of HCPs and HCP interactions to develop a curated sales and marketing strategy. An algorithm then learns and adapts in real-time to deliver content that ultimately changes prescribing behaviors.

“We believe the ability to deploy Indegene’s range of digital best practices and new communications channels will play a large role in the pre-launch preparation, and enable Cingulate to immediately tap into the proven market access, sales force effectiveness and medical commercialization operations critical to a successful launch,” Moore added. “We have worked with 19 of the top 20 global pharmaceutical companies, and this joint commercialization agreement expands Indegene’s services to an emerging growth company, positioning Cingulate for success in the event CTx-1301 is approved by the FDA.”

Of the multitude of medications available for the more than 17 million child, adolescent, and adult patients in the U.S. living with ADHD, there is currently no available medication offering a single oral dose that provides patients entire active-day efficacy. CTx-1301 aims to be the first medication to achieve fast onset of action (in 30 minutes or less) and efficacy that lasts up to 16 hours while improving patient tolerability.

About CTx-1301
Cingulate’s lead candidate, CTx-1301, utilizes the Company’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 remains, providing patients 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.

The company has initiated the first of two Phase 3 clinical studies of CTx-1301 to support its NDA submission. The pivotal, Phase 3 fixed-dose trial in children and adolescents is scheduled to begin in mid-2023.

About Precision Timed Release™ (PTR™) Platform Technology
Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using the Company’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 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.

For more information visit Cingulate.com/technology.

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.

About Indegene
We are a digital-first, life sciences commercialization company. We help biopharmaceutical, emerging biotech and medical device companies develop products, get them to the market, and grow their impact through the life cycle in a more effective, efficient, and modern way. We bring together healthcare domain expertise, fit-for-purpose technology, and an agile operating model to provide a diverse range of solutions. These aim to deliver, amongst other outcomes, a personalized, scalable and omnichannel experience for patients and physicians. It’s what drives our team and our purpose to enable healthcare organizations to be future ready. To learn more, please visit www.indegene.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 28, 2022. 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

Media Relations:

Melysa Weible
Elixir Health Public Relations
mweible@elixirhealthpr.com
201-723-5805

Yadunandan K V
Director - Corporate Communications, Indegene
yadunandan.kv@indegene.com

CING-US-120-0324