Submitted New Drug Application (NDA) to the FDA for lead asset CTx-1301 Anticipate FDA Decision in Q4 2025 regarding NDA Acceptance with Potential PDUFA Date in Mid-2026

Jennifer Callahan, Chief Financial Officer, appointed Interim CEO Board member, Jay Roberts appointed Executive Chairman KANSAS CITY, Kan., Aug. 15, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CING) The Board of Directors of Cingulate Inc. (“Cingulate”) announced that it has placed Chairman and Chief Executive Officer, Shane J.

Regulatory filing marks significant milestone for medication designed to provide once-daily, entire active-day symptom control in ADHD patients Regulatory filing marks significant milestone for medication designed to provide once-daily, entire active-day symptom control in ADHD patients

Dallas, Texas--(Newsfile Corp. - June 18, 2025) - Cingulate Inc. (NASDAQ: CING): Stonegate Capital Partners initiates their coverage on Cingulate Inc. (NASDAQ: CING). Cingulate reported 1Q25 results that highlight continued progress toward the commercial launch of its lead ADHD asset, CTx-1301.

Industry Leader with 30+ Years of Experience Will Drive Strategic Growth and Partnerships SCOTTSDALE, Ariz., May 27, 2025 /PRNewswire/ -- Life365, a leading data engagement and virtual care company, today announced the appointment of healthcare executive and investor Jay Roberts as chief development officer. Roberts, who previously served as an executive advisor to Life365, brings more than 30 years of strategic healthcare leadership experience to this pivotal role. Life365's platform enables the next generation of AI-driven healthcare for enterprise healthcare organizations, payers, and government entities. In his new position, Roberts will spearhead the company's strategic growth initiatives, including securing funding, building strategic partnerships, and fostering relationships with key stakeholders to accelerate Life365's market expansion and long-term success. "We've already benefited tremendously from Jay's strategic insights during his time as an advisor," said Life365 Founder and CEO Kent Dicks. "His deep expertise in healthcare finance and innovation, coupled with his passion for advancing medical technology, will be invaluable as we pursue our mission to safely and cost-effectively connect patients to care from the comfort of their homes." Roberts expressed enthusiasm about his expanded role: "Life365 stands at the forefront of healthcare innovation, leveraging advanced technologies like AI to extract actionable insights from patient-generated health data. These insights enable more proactive, preventive care models that can transform healthcare delivery. I'm excited to collaborate with Kent and our investors as Life365 revolutionizes remote patient monitoring to personalize care, improve outcomes, and enhance patient engagement across the healthcare ecosystem." Extensive Healthcare Leadership Experience Beyond his role at Life365, Roberts serves as a partner with Ventac Partners, a global catalyst in life sciences that creates breakthrough companies, bringing scientific innovation to patients worldwide. He is also a venture partner for DigiLife Fund II, where he leads fundraising, due diligence, and investment decisions alongside DigiLife team members and syndicate investment funds. Roberts' governance expertise extends to several prominent roles, including membership on the Board of Trustees of U.S. Pharmacopeia and service on the boards of directors for multiple healthcare companies, including Cingulate (Nasdaq: CING), Caidya Research, Veriskin, NaviPoint Health, and Vyant Bio. Until February 2023, Roberts served as president and CEO of Vyant Bio, an innovative biotechnology company reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders. Throughout his distinguished career, Roberts has held chief executive officer, chief operating officer (COO), and chief financial officer (CFO) positions for Nasdaq publicly traded companies and venture and private equity-backed healthcare technology organizations. His experience spans diagnostics, software solutions, and manufacturing companies, with involvement in more than 50 M&A and debt and equity transactions. Roberts previously served as CEO and COO of Cancer Genetics. Prior to that, he was CFO for VirMedica, an innovative technology solutions company. A current member of the Alliance of CEOs, Roberts is recognized as a thought leader and expert panelist for numerous programs and publications on topics, including "conscious capitalism," leadership and mentoring, corporate finance, mergers and acquisitions, capital formation, and healthcare innovation. He holds an MBA from the University of Maine. About Life365 Life365 is a leading developer of virtual care technology solutions that enable healthcare delivery at home. The Life365 platform addresses key care delivery challenges by providing scalable solution integration and logistics to enterprise healthcare organizations, enabling patient connectivity, engagement, and improved outcomes for diverse patient populations. The platform serves as a single integration point that enables providers, payers, and other stakeholders to implement a proactive, virtual-first care approach to remotely engage and monitor patients with various conditions and needs, including chronic disease management, post-discharge care, and population health management. Led by an experienced, industry-recognized team, Life365 is a major patent holder of wearables, sensors, and patches driven by machine learning/AI, driving the next generation of scalable remote patient monitoring. Life365 serves as a strategic partner of Microsoft Cloud for Healthcare and the Veterans Administration, supporting the largest population of veterans in the world. For more information, visit www.life365.health. Media Contact:Kendall Paulsen | Life365[email protected]888-818-2322 x705

Pre-NDA Meeting for CTx-1301(dexmethylphenidate) Held April 2, 2025; New Drug Application Submission Targeted for Mid-2025

CTx-2103 has the Potential to be the First, Once-Daily Formulation of Buspirone, one of the Most Widely Prescribed Agents in the $5.5 Billion U.S. Anxiety Market, and the $11.6 Billion Anxiety Market Worldwide

In-Person FDA Meeting Scheduled for April 2; New Drug Application Submission Targeted for Mid-2025 $17.5 million increase in Working Capital; Cash Runway Extending into Q4, Well Beyond Target Date for NDA Submission

KANSAS CITY, Kan., Dec. 23, 2024 (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, has completed a financing transaction with an accredited investor which provided net proceeds to CING of $5 million.

On Target for Mid-2025 New Drug Application (NDA) Submission of lead ADHD asset CTx-1301 On Target for Mid-2025 New Drug Application (NDA) Submission of lead ADHD asset CTx-1301