Cingulate secures manufacturing deal with Bend Bio Sciences for ADHD drug

KANSAS CITY - Cingulate Inc. (NASDAQ:CING), a clinical-stage biopharmaceutical company with a current market capitalization of $22 million, has entered into a commercial supply agreement with Bend Bio Sciences for the manufacturing of CTx-1301, its lead ADHD treatment candidate, the company announced Wednesday. According to InvestingPro data, while the company maintains more cash than debt on its balance sheet, it faces significant financial challenges with rapid cash burn.

Under the agreement, Bend Bio Sciences will serve as the exclusive commercial manufacturer of CTx-1301 in the United States through 2028, if the drug receives FDA approval. Cingulate submitted its New Drug Application (NDA) for CTx-1301 to the FDA on July 31, 2025.

CTx-1301 is an extended-release tablet formulation of dexmethylphenidate, a stimulant medication commonly used to treat attention deficit/hyperactivity disorder. The drug utilizes Cingulate’s Precision Timed Release drug delivery platform, which is designed to provide three precisely timed releases of medication throughout the day in a single tablet.

"Following our successful NDA submission last month, this exclusive manufacturing partnership with Bend Bio Sciences marks another pivotal step in our commercialization strategy," said Jay Roberts, Executive Chairman of Cingulate, in the press release. With the company’s stock down nearly 24% over the past year and analysts revising earnings estimates downward, investors are closely monitoring the development pipeline. InvestingPro subscribers can access detailed financial health metrics and 8 additional expert insights about Cingulate’s market position.

The agreement requires Cingulate to purchase 100% of its U.S. commercial supply of CTx-1301 from Bend Bio Sciences, subject to FDA approval.

According to the company, ADHD affects over 20 million patients in the United States, including 12 million adults and over 8 million children under age 17. The company stated that current market trends show adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined. Despite this substantial market opportunity, Cingulate faces significant challenges, with an EBITDA of -$17.2 million in the last twelve months and analyst price targets ranging from $8 to $62 per share. Discover more comprehensive market analysis and company valuations with InvestingPro’s advanced tools and real-time metrics.

Cingulate’s drug delivery technology incorporates what the company calls an Erosion Barrier Layer, which controls drug release at pre-defined times with no release prior to the intended release time.

In other recent news, Cingulate Inc. has reported a series of unregistered sales of equity securities, issuing a total of 325,729 shares of its common stock between July 30 and a recent Friday to address portions of debt owed to a lender. The company issued shares at various prices, including $5.16, $4.05, $3.90, $3.94, and $3.79 per share on different dates. Additionally, Cingulate has undergone significant leadership changes as the board of directors appointed John A. Roberts as Executive Chairman, while CEO Shane Schaffer was placed on administrative leave following a criminal charge. Jennifer Callahan, the current Chief Financial Officer, has been named interim CEO, maintaining her CFO responsibilities during this period. Ascendiant Capital has also raised its stock price target for Cingulate to $62 from $61, maintaining a Buy rating. This valuation reflects potential growth from the current share price. These developments indicate a period of transition and adjustment for Cingulate.

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