Cingulate Receives $3 Million Grant from Private Foundation to Accelerate Development of Anxiety Asset CTx-2103 (buspirone)
Cingulate Inc. (NASDAQ: CING) has secured a $3 million grant from a private foundation to accelerate the development of CTx-2103 (buspirone) for anxiety treatment. The grant will be distributed in three $1 million tranches, with the first payment scheduled for May 1st and subsequent tranches tied to development milestones.
CTx-2103 aims to be the first once-daily formulation of buspirone in the $5.5 billion U.S. anxiety market ($11.6 billion globally). The foundation will receive quarterly royalties of $500,000 after commercialization, capped at $3.5 million total. The development leverages Cingulate's proprietary Precision Timed Release™ (PTR™) drug delivery platform technology.
This initiative addresses a significant medical need, as anxiety disorders affect approximately 31% of U.S. adults and represent the most common mental health concern in America, according to the National Institutes of Mental Health.
Cingulate Inc. (NASDAQ: CING) ha ottenuto un finanziamento di 3 milioni di dollari da una fondazione privata per accelerare lo sviluppo di CTx-2103 (buspirone) per il trattamento dell'ansia. Il finanziamento sarà distribuito in tre tranche da 1 milione di dollari ciascuna, con il primo pagamento previsto per il 1° maggio e le tranche successive legate a traguardi di sviluppo.
CTx-2103 mira a diventare la prima formulazione di buspirone da assumere una volta al giorno nel mercato dell'ansia negli Stati Uniti da 5,5 miliardi di dollari (11,6 miliardi a livello globale). La fondazione riceverà royalties trimestrali di 500.000 dollari dopo la commercializzazione, fino a un massimo totale di 3,5 milioni di dollari. Lo sviluppo sfrutta la tecnologia della piattaforma di somministrazione di farmaci proprietaria di Cingulate, Precision Timed Release™ (PTR™).
Questa iniziativa risponde a un'importante esigenza medica, poiché i disturbi d'ansia colpiscono circa il 31% degli adulti statunitensi e rappresentano la preoccupazione per la salute mentale più comune in America, secondo gli Istituti Nazionali di Salute Mentale.
Cingulate Inc. (NASDAQ: CING) ha obtenido una de una fundación privada para acelerar el desarrollo de CTx-2103 (buspirona) para el tratamiento de la ansiedad. La subvención se distribuirá en tres tramos de 1 millón de dólares, con el primer pago programado para el 1 de mayo y los tramos posteriores vinculados a hitos de desarrollo.
CTx-2103 tiene como objetivo ser la primera formulación de buspirona de una vez al día en el mercado de la ansiedad de EE. UU. de 5,5 mil millones de dólares (11,6 mil millones a nivel global). La fundación recibirá regalías trimestrales de 500,000 dólares después de la comercialización, con un límite total de 3,5 millones de dólares. El desarrollo aprovecha la tecnología de la plataforma de entrega de medicamentos patentada de Cingulate, Precision Timed Release™ (PTR™).
Esta iniciativa aborda una necesidad médica significativa, ya que los trastornos de ansiedad afectan aproximadamente al 31% de los adultos en EE. UU. y representan la preocupación de salud mental más común en América, según los Institutos Nacionales de Salud Mental.
Cingulate Inc. (NASDAQ: CING)는 불안 치료를 위한 CTx-2103 (부스피론)의 개발을 가속화하기 위해 민간 재단으로부터 300만 달러의 보조금을 확보했습니다. 이 보조금은 3회의 100만 달러 분할 지급으로 나뉘며, 첫 번째 지급은 5월 1일에 예정되어 있으며, 이후 분할 지급은 개발 이정표에 따라 지급됩니다.
CTx-2103은 55억 달러 규모의 미국 불안 시장 (전 세계적으로 116억 달러)에서 하루 한 번 복용하는 부스피론의 첫 번째 제형이 되는 것을 목표로 하고 있습니다. 이 재단은 상용화 후 분기마다 50만 달러의 로열티를 받게 되며, 총 350만 달러로 한정됩니다. 이 개발은 Cingulate의 독점 Precision Timed Release™ (PTR™) 약물 전달 플랫폼 기술을 활용합니다.
이 이니셔티브는 중요한 의료 필요를 해결하며, 불안 장애는 약 미국 성인의 31%에 영향을 미치고 있으며, 미국에서 가장 흔한 정신 건강 문제를 나타냅니다. 이는 미국 국립 정신 건강 연구소에 따르면 그렇습니다.
Cingulate Inc. (NASDAQ: CING) a obtenu une subvention de 3 millions de dollars d'une fondation privée pour accélérer le développement de CTx-2103 (buspirone) pour le traitement de l'anxiété. La subvention sera distribuée en trois tranches de 1 million de dollars, le premier paiement étant prévu pour le 1er mai et les tranches suivantes étant liées à des jalons de développement.
CTx-2103 vise à être la première formulation de buspirone à prendre une fois par jour sur le marché de l'anxiété aux États-Unis de 5,5 milliards de dollars (11,6 milliards de dollars au niveau mondial). La fondation recevra des redevances trimestrielles de 500 000 dollars après la commercialisation, plafonnées à 3,5 millions de dollars au total. Le développement utilise la technologie de plateforme de délivrance de médicaments propriétaire de Cingulate, Precision Timed Release™ (PTR™).
Cette initiative répond à un besoin médical significatif, car les troubles anxieux touchent environ 31 % des adultes aux États-Unis et représentent le problème de santé mentale le plus courant en Amérique, selon les Instituts nationaux de la santé mentale.
Cingulate Inc. (NASDAQ: CING) hat einen 3-Millionen-Dollar-Zuschuss von einer privaten Stiftung erhalten, um die Entwicklung von CTx-2103 (Buspiron) zur Behandlung von Angstzuständen zu beschleunigen. Der Zuschuss wird in drei Tranchen von jeweils 1 Million Dollar verteilt, wobei die erste Zahlung für den 1. Mai geplant ist und die anschließenden Tranchen an Entwicklungsmeilensteine gebunden sind.
CTx-2103 soll die erste einmal täglich einzunehmende Formulierung von Buspiron auf dem 5,5 Milliarden Dollar schweren US-Angstmarkt (11,6 Milliarden Dollar weltweit) werden. Die Stiftung erhält nach der Kommerzialisierung vierteljährliche Lizenzgebühren von 500.000 Dollar, die auf insgesamt 3,5 Millionen Dollar begrenzt sind. Die Entwicklung nutzt die proprietäre Precision Timed Release™ (PTR™) Arzneimittellieferplattform-Technologie von Cingulate.
Diese Initiative adressiert einen erheblichen medizinischen Bedarf, da Angststörungen etwa 31 % der US-Erwachsenen betreffen und das häufigste psychische Gesundheitsproblem in Amerika darstellen, so die National Institutes of Mental Health.
- Secured non-dilutive funding of $3 million for CTx-2103 development
- Targeting large market opportunity: $5.5B U.S. and $11.6B global anxiety market
- Potential first-mover advantage with once-daily buspirone formulation
- Capped royalty obligation of $3.5 million
- Product development subject to milestone achievements for full grant receipt
- Future royalty payments will impact revenue after commercialization
Insights
Cingulate's $3 million non-dilutive grant represents a significant positive development for this small biopharmaceutical company. The structured disbursement—three $1 million tranches with milestone-based requirements—provides both immediate capital and accountability for development progress.
The financing terms are notably favorable. While the foundation will receive royalties after commercialization ($500,000 quarterly payments), the maximum cumulative royalty is capped at $3.5 million. This represents just a 16.7% return on the foundation's investment, substantially below typical venture capital or dilutive financing costs.
This funding accomplishes three critical objectives: it extends Cingulate's operational runway, validates their proprietary PTR™ technology platform, and accelerates development of a potential first-in-class product targeting the $5.5 billion U.S. anxiety market. The non-dilutive structure preserves shareholder equity while expanding their pipeline beyond existing assets.
The foundation's willingness to invest signals external confidence in both the technology platform and CTx-2103's commercial potential. For a smaller biopharmaceutical company, securing specialized non-dilutive funding provides significant strategic flexibility compared to traditional financing options that typically involve substantial equity dilution or onerous terms.
Cingulate's advancement of CTx-2103 represents a compelling opportunity in the anxiety treatment landscape. Buspirone is a well-established anxiolytic with decades of clinical data supporting its efficacy and, critically, lacks the dependency and withdrawal issues associated with benzodiazepines. The key limitation has always been its inconvenient dosing schedule.
The potential to create the first once-daily buspirone formulation addresses a significant unmet need. Current buspirone requires multiple daily doses, which reduces patient adherence and limits clinical effectiveness. The simplified once-daily regimen could substantially improve treatment outcomes while providing a strong competitive advantage in the $11.6 billion global anxiety market.
Cingulate's Precision Timed Release™ platform is particularly well-suited for buspirone due to the drug's pharmacokinetic profile. The technology can potentially optimize the delivery curve to maintain therapeutic levels throughout a 24-hour period. This application further validates the platform's versatility beyond their initial focus areas.
From a clinical perspective, expanding non-benzodiazepine anxiety treatment options addresses growing concerns about benzodiazepine misuse, dependency, and withdrawal complications. Regulators and prescribers increasingly favor treatments without these risks, potentially accelerating adoption if CTx-2103 reaches commercialization. The private foundation's support aligns with this important public health objective.
CTx-2103 has the Potential to be the First, Once-Daily Formulation of Buspirone, one of the Most Widely Prescribed Agents in the
Non-Dilutive Funding Expands Pipeline and Further Validates Cingulate’s Proprietary Precision Timed Release™ Drug Delivery Technology
CTx-2103 has the Potential to Reduce Use of Benzodiazepine’s and Associated Withdrawal and Dependency Issues
KANSAS CITY, Kan., April 09, 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, announced today that it has received a
The grant will be made in three tranches of
“This grant was made by a private foundation whose foremost interest is combating the global rise of critical health issues such as anxiety in a consequential way. We thank the foundation for this funding for the development of CTx-2103, which advances Cingulate’s pipeline and illustrates the applicability of our PTR™ platform. Today, we are one step closer to providing the first, once-daily medicine for the millions of patients worldwide who suffer from anxiety-related disorders, the most common mental health issue in America and around the world,” said Cingulate Chairman and CEO Shane J. Schaffer.
According to the National Institutes of Mental Health (NIMH), anxiety disorders are the most common mental health concern in the U.S. An estimated 31 percent of U.S. adults experience an anxiety disorder at some time in their lives. People may live with anxiety for years before they are diagnosed or treated. 1
About CTx-2103
CTx-2103 is a novel, multi-release tablet of buspirone that incorporates Cingulate’s proprietary PTR™ drug delivery platform. CTx-2103 is being studied for the treatment of anxiety and/or anxiety-related disorders. Buspirone, an azapirone derivative and a 5-HT1A partial agonist, was the first non-benzodiazepine anxiolytic introduced for the treatment of generalized anxiety disorder. Buspirone may exhibit a decreased side-effect profile compared to other anxiolytic treatments. Unlike benzodiazepines and barbiturates, there is no associated risk of physical dependence or withdrawal with buspirone use due to the lack of effects on gamma-aminobutyric acid receptors.
About Anxiety
Anxiety disorders are the most common mental health concern in the U.S.1 Anxiety is the feeling of fear that occurs when faced with threatening or stressful situations or can be endogenous and not have an identified stressor. It can be a normal response when confronted with danger, but, if severe and chronic and affects functioning, it could be regarded as an anxiety disorder. An estimated 31 percent of U.S. adults experience an anxiety disorder at some time in their lives. People may live with anxiety for years before they are diagnosed or treated. The global COVID-19 crisis has exacerbated the diagnosis and treatment of anxiety and anxiety related disorders and as a result is a priority within the class of unmet medical needs in mental health.1
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.
Forward-Looking Statements
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Investor & Public 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
FAQ
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