Buspirone Hydrochloride

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 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 $3 million grant to accelerate the development of CTx-2103 (buspirone) for the treatment of anxiety. 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 ($11.6 billion global). The grant will be made in three tranches of $1 million each, the first tranche to be paid on May 1st , and the two subsequent tranches payable based on specified product development milestones. The foundation will receive a future royalty contingent on the commercialization of CTx-2103, beginning six months after the after the first commercial sale of CTx-2103, payable at $500,000 per quarter, with a maximum cumulative royalty of $3.5 million. “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 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 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 & 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

$17.8 Million Raised Since Beginning of 2023$9.1 Million of Debt Converted to Equity at a PremiumPhase 3 ADHD Data Continues to Impress KANSAS CITY, Kan., April 01, 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, today announced its financial results for the twelve months ended December 31, 2023, and provided a clinical and business update. Highlights include capital raised from multiple sources and the addition of three independent board members. “I am pleased to report that Cingulate is stronger today than the end of last year,” said Shane J. Schaffer, Chairman and CEO of Cingulate Inc. “With the addition of three independent directors, each of whom possess deep experience in the pharmaceutical industry, small-cap publicly traded companies, and hold executive leadership roles within pharma, the Cingulate board is equipped to overcome the challenges ahead. “Our lead asset CTx-1301 continues to impress clinical investigators and key opinion leaders as we share our Phase 3 results. In addition, pharmaceutical companies in the U.S., Europe, and other territories have engaged in licensing discussions regarding their interest to commercialize our product. These tailwinds put Cingulate in a position to obtain non-dilutive capital and expand our pipeline of assets. “We are encouraged to see the capital markets improving as evidenced by our ability to raise more than $17 million dollars over the past year. Looking ahead, Cingulate has several financial instruments in place to raise additional capital while fighting to preserve shareholder’s equity. “Overall, I am very pleased with the progress made by our team in 2023 and into 2024. Our focus remains on executing our strategic plan and submitting CTx-1301 to the FDA.” CTx-1301 Data Exhibits Strong Effect Size On January 20, 2024, Cingulate presented results from the Phase 3 adult efficacy and safety study of its lead candidate, CTx-1301 (dexmethylphenidate), for the treatment of Attention Deficit / Hyperactivity Disorder (ADHD), at the 2024 American Professional Society of ADHD and Related Disorders (APSARD) conference in Orlando, FL. The results were previously presented at the 36th Annual Psych Congress in September 2023, where the data was selected as a finalist for the Psych Congress’s First Annual Poster Awards. The Cingulate poster presented at APSARD provided additional insight regarding CTx-1301’s impressive effect size. Effect size conveys clinical significance rather than statistical significance, is not reliant on sample size, and allows for comparison across trials. The poster presented may be viewed here. The study was not intended nor did it achieve statistical significance on the primary endpoint but demonstrated a trend towards significance despite its modest sample size in improving ADHD symptoms with a rapid onset of action and entire active-day duration. Cingulate Receives Guidance from FDA on Path Forward for Anxiety Asset CTx-2103 (buspirone) In December 2023, Cingulate received input from the FDA regarding the regulatory pathway for CTx-2103, and the design of clinical studies for filing of an IND. Based on this FDA feedback, we believe that we can seek and win approval of CTx-2103 under the 505(b)(2) pathway, which typically requires less time and resources than the 505(b)(1) full NDA pathway. $10.7 Million of Capital Raised and $3.3 Million of Debt Converted to Equity in 2024 Since January 1, 2024, the Company sold shares of common stock under its At the Market Offering Agreement with H.C. Wainwright & Co., LLC for gross proceeds of $3.2 million. In February 2024, the Company closed a $7.5 million public offering of its common stock (or pre-funded warrants in lieu thereof) and Series A and Series B warrants to purchase shares of common stock, at a public offering price of $2.00 per share (or common stock equivalent in lieu thereof) and accompanying warrants. Additionally, in January 2024, Werth Family Investment Associates, LLC (WFIA), the manager of which is Peter J. Werth, a member of the Cingulate board of directors, converted at a 10 percent premium to market the remaining $3.3 million of outstanding debt plus accrued interest into pre-funded warrants to purchase shares of common stock. $7.1 Million of Capital Raised and $5.8 Million of Debt Converted to Equity in 2023 In September 2023, Cingulate closed a $4.0 million public offering of shares of common stock (or common stock equivalents in lieu thereof) and Series A and Series B warrants to purchase shares of common stock, at public offering price of $11.55 per share (or common stock equivalent in lieu thereof) and accompanying warrants. In addition, during 2023, Cingulate sold shares of common stock through its ATM Agreement and its Purchase Agreement with Lincoln Park Capital Fund, LLC for aggregate gross proceeds of $2.1 million. Finally, in August 2023, WFIA purchased shares of common stock for $1.0 million through a private placement priced at the market and, in September 2023, WFIA converted at a 47% premium to market $5.8 million of outstanding debt and accrued interest into pre-funded warrants to purchase shares of common stock. Jennifer Callahan Promoted to CFO In January 2024, Cingulate promoted longtime Controller Jennifer Callahan to Chief Financial Officer, succeeding Lou Van Horn, who retired from the company in December 2023. Three Independent Directors Appointed to Cingulate Board In February 2024, Cingulate appointed three independent directors to its board: Jay Roberts, Bryan Lawrence, and Jeff Ervin. Please visit Cingulate.com for more information about the new directors. Fourth Quarter and Full Year Results Cash Position: As of December 31, 2023, Cingulate had $52,416 in cash and cash equivalents. Additionally, we have raised $10.7 million from the sale of securities in 2024 to date and we believe that our cash will satisfy our capital needs through late in the second quarter of 2024 under our current business plan. Management continues to evaluate additional strategies to obtain funding, which may include additional equity offerings, issuance of debt, or other capital sources, including potential collaborations with other companies or other strategic transactions. R&D Expenses: Research and development expenses were $5.0 million for the three months ended December 31, 2023, compared to $1.9 million for the same period in 2022. Research and development expenses were $15.5 million for the year ended December 31, 2023, compared to $9.0 million for the year ended December 31, 2022. These increases were primarily the result of increased clinical activity in 2023 as compared to 2022. During the third quarter of 2023, we initiated two Phase 3 studies for CTx-1301, the pediatric dose optimization onset and duration study and the fixed dose pediatric and adolescent safety and efficacy study. In addition, the Phase 3 adult dose-optimization study for CTx-1301 was completed in June 2023. Manufacturing for these Phase 3 studies also occurred during 2023. G&A Expenses: General and administrative expenses were $1.8 million for the three months ended December 31, 2023, compared to $2.5 million for the same period in 2022. General and administrative expenses were $7.3 million for the year ended December 31, 2023, compared to $8.5 million for the year ended December 31, 2022. These decreases were primarily the result of a decrease in our directors’ and officers’ insurance premium from 2022 to 2023. The decrease in directors’ and officers’ insurance premium was offset by increases in certain professional fees primarily the result of the timing of services performed relating to our annual audit. Net Loss: Net loss was $6.9 million for the three months ended December 31, 2023, compared to $4.6 million for the same period in 2022. Net loss was $23.5 million for the year ended December 31, 2023, compared to $17.7 million for the year ended December 31, 2022. The increase in the net loss from 2022 to 2023 primarily relates to a significant increase in development activity as described above. Cingulate Inc.Consolidated Balance Sheet Data December 31, December 31, 2023 2022 Cash and cash equivalents$52,416 $5,356,276 Total assets$3,491,436 $11,405,057 Total liabilities$10,360,865 $7,523,035 Accumulated deficit$(92,943,443) $(69,408,496)Total stockholders' equity$(6,869,429) $3,882,022 Cingulate Inc.Consolidated Statements of Operations Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Operating expenses: Research and development$4,984,909 $1,931,654 $15,493,304 $8,995,280 General and administrative 1,812,242 2,543,371 7,265,885 8,506,438 Operating loss (6,797,151) (4,475,025) (22,759,189) (17,501,718) Interest and other income (expense), net (137,546) (130,002) (775,758) (174,514)Loss before income taxes (6,934,697) (4,605,027) (23,534,947) (17,676,232)Income tax benefit (expense) - - - - Net loss$ (6,934,697) $ (4,605,027) $ (23,534,947) $ (17,676,232) About Cingulate®Cingulate Inc. is 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, 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 Attention Deficit/Hyperactivity Disorder (ADHD), Cingulate is identifying and evaluating additional therapeutic areas where its PTR technology may be employed to develop future product candidates, such as anxiety disorders. Cingulate is headquartered in Kansas City, KS. For more information visit Cingulate.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 10, 2023. 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 & Public Relations:Thomas DaltonVice President, Investor & Public Relations, Cingulatetdalton@cingulate.com(913) 942-2301 Matt KrepsDarrow Associatesmkreps@darrowir.com(214) 597-8200