Cingulate Secures Exclusive Manufacturing Partnership with Bend Bio Sciences to Support Future Commercialization of Next Generation ADHD Treatment
Cingulate (NASDAQ: CING) has secured an exclusive commercial manufacturing partnership with Bend Bio Sciences for CTx-1301, its lead ADHD treatment candidate. The agreement extends through 2028 and positions CTx-1301 for commercial launch, pending FDA approval.
The partnership follows Cingulate's NDA submission to the FDA on July 31, 2025 for CTx-1301, a novel extended-release dexmethylphenidate formulation utilizing the company's Precision Timed Release™ (PTR™) technology. Under the agreement, Bend Bio Sciences will be the exclusive U.S. manufacturer, with Cingulate committing to purchase 100% of its commercial supply from Bend following potential FDA approval.
- Exclusive manufacturing partnership secured through 2028, ensuring supply chain stability
- NDA already submitted to FDA for CTx-1301, showing regulatory progress
- Agreement provides manufacturing security and operational efficiency for commercial readiness
- Partnership leverages Bend's expertise in complex modified-release dosage forms
- 100% supply commitment to single manufacturer could pose concentration risk
- Commercial success depends on pending FDA approval
Insights
Cingulate's manufacturing deal with Bend Bio Sciences secures commercial production for their pending ADHD drug, strengthening their market entry preparations.
This manufacturing partnership represents a critical commercialization milestone for Cingulate as they position CTx-1301 for potential market entry. By securing Bend Bio Sciences as their exclusive commercial manufacturer through 2028, Cingulate has addressed one of the most significant operational hurdles biotechnology companies face when transitioning from development to commercialization.
The timing is strategically sound, coming shortly after their NDA submission on July 31, 2025. This sequential approach demonstrates disciplined execution of their pre-launch strategy, as manufacturing partnerships typically require months of planning and negotiation.
The exclusivity component and Cingulate's commitment to purchase 100% of U.S. commercial supply from Bend suggests favorable economics for both parties and likely includes volume-based pricing that could positively impact margins. For a small biopharma company, securing manufacturing capacity with an experienced partner significantly reduces operational risk.
CTx-1301's formulation uses Cingulate's proprietary Precision Timed Release technology platform, which aims to address limitations in current ADHD medications. The multi-phase release tablet mentioned requires specialized manufacturing capabilities, which explains why partnering with a company experienced in modified-release formulations is strategically important rather than attempting in-house production.
This agreement indicates Cingulate's confidence in potential FDA approval and demonstrates proactive supply chain management ahead of commercialization. The company is methodically removing obstacles to commercial readiness while their NDA undergoes FDA review.
Strategic Commercial Supply Agreement Positions Lead Asset CTx-1301 for Launch Pending FDA Approval
KANSAS CITY, Kan., Sept. 17, 2025 (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 entered into a commercial supply agreement with Bend Bio Sciences for the manufacturing of CTx-1301(dexmethylphenidate HCl), the company’s lead asset for the treatment of attention deficit/hyperactivity disorder (ADHD).
CTx-1301 is a novel, extended-release tablet formulation of dexmethylphenidate designed to address major limitations of current ADHD therapies. Cingulate submitted its NDA to the FDA for CTx-1301 on July 31, 2025.
Strategic Partnership Drives Commercial Readiness
Under the new agreement, Bend Bio Sciences will serve as the exclusive commercial manufacturer of CTx-1301 in the United States through 2028, if approved by the FDA, and Cingulate has committed to purchasing
"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. "This agreement not only secures our manufacturing capabilities but demonstrates our commitment to delivering consistent, high-quality supply of CTx-1301 to serve the millions of patients who need ADHD treatment options."
Bend Chief Executive Officer Owen Murray stated, "We’re proud to expand our years-long partnership with Cingulate as they advance this important next-generation therapy into commercial manufacturing. The complexity and precision required for this multi-phase release tablet aligns perfectly with our technical strengths in modified-release dosage forms and oral solid drug delivery. It's a formulation designed with the patient in mind and we’re honored to support its success.”
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., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65–90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined.
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 provide patient care in one tablet.
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 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 Bend Bioscience
Formed from three specialist CDMOs, Bend Bioscience offers bolder science and bigger impact across small molecule capabilities and enabling technologies. From pre-clinical to commercial scale, Bend provides its clients with the highest levels of service and science, combining the broad capabilities of a large CDMO with the flexibility and speed of an expert partner. We employ our scientific expertise to optimize formulation designs with a focus on enhanced pharmacokinetics, and deploying enabling technologies such as spray dried dispersions, particle engineering, multi-particulate dosage forms and modified release technologies to affect desired release profiles and in vivo bioavailability. Our partnering approach brings molecules through the clinic, to scaled manufacturing and launch through our network of three specialized, newly expanded facilities in the U.S., from where we offer accelerated solutions for orphan, breakthrough and specialty programs, as well as tech transfer expertise to ease transition from early development to commercial production.
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, the potential approval and commercialization of CTx-1301 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 27, 2025, and our other filings with the SEC. 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 & Media Relations:
Thomas Dalton
Vice President, Corporate Communications, Cingulate
tdalton@cingulate.com
(913) 942-2301
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