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Name | Symbol | Market | Type |
---|---|---|---|
Cingulate Inc | NASDAQ:CINGW | NASDAQ | Equity Warrant |
Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.0001 | 0.83% | 0.0122 | 0.0121 | 0.0299 | 0.0122 | 0.0122 | 0.0122 | 200 | 21:00:02 |
“We are excited to have reached several important milestones,” said Cingulate Chairman & CEO Shane J. Schaffer. “Cingulate has now answered the question as to how it will commercialize CTx-1301 by entering into a joint commercialization agreement with Indegene that substantially reduces the risks and expenses associated with traditional commercialization, and earlier this month, we announced the successful transfer of Cingulate’s proprietary PTR manufacturing processes to Societal CDMO in Gainesville, Georgia, keeping our Phase 3 timelines on schedule.”
“Furthermore,” Schaffer continued, “we are pleased to announce that we’ve received additional non-dilutive financing from long-standing Cingulate investor and board member Peter J. Werth. Capital will always be critical to Cingulate’s long-term success, and as we look forward to multiple Phase 3 milestones later this summer, we thank Peter for this additional financing and his steadfast support for Cingulate’s pipeline, vision, and overall mission.”
Werth Family Investment Associates Provides $3 Million of Debt Financing
Cingulate received an additional $3.0 million of debt financing from Werth Family Investment Associates LLC (WFIA). The $5.0 million promissory note, dated August 9, 2022, in favor of WFIA was amended and restated to increase the principal amount to $8.0 million with no changes to the other terms of the note. The note is unsecured with interest accruing at 15% per annum. Outstanding principal and all accrued and unpaid interest is due and payable on August 8, 2025 unless accelerated due to an event of default, and WFIA has the right during the first five business days of each calendar quarter to demand payment of all outstanding principal and interest 120 days following notice to Cingulate. WFIA owns 975,165 shares of our common stock and Peter J. Werth, a member of the Company’s Board of Directors and the manager of WFIA, owns 21,849 shares of our common stock.
Cingulate Completes Transfer of Proprietary PTR™ Manufacturing Processes to Societal CDMO
In April 2023, Cingulate successfully completed the transfer of its proprietary PTR™ manufacturing processes for its lead candidate, CTx-1301 (dexmethylphenidate), to Societal, a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development. Societal is producing a scalable supply of CTx-1301 for Cingulate’s ongoing and upcoming Phase 3 trials in the manufacturing suite within Societal’s Gainesville, Georgia facility that is outfitted with equipment supplied by Cingulate.
Cingulate, Indegene Announce Joint Commercialization Agreement for Lead ADHD Candidate CTx-1301
In March 2023, Cingulate announced a joint commercialization agreement with Indegene, a comprehensive life sciences commercialization company, to provide commercial support for Cingulate’s lead candidate CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity disorder (ADHD).
The agreement spans cross-functional services through an omnichannel marketing approach uniquely designed to successfully manage pre-commercial support during Cingulate’s Phase 3 clinical trials and to effectively commercialize CTx-1301 nationwide following potential FDA approval.
Clinical Update
Cingulate initiated a Phase 3 adult dose-optimization study in December 2022 to assess onset and duration of efficacy and safety in adults with ADHD, first cohort has been completed and the second cohort is near completion. Results are expected in the third quarter of 2023.
The Phase 3 fixed-dose pediatric and adolescent safety and efficacy study is expected to commence in mid-2023; results are expected in the first quarter of 2024.
In addition, Cingulate is planning to initiate a Phase 3 pediatric and adolescent dose-optimization classroom study in the third quarter of 2023 to assess onset and duration and efficacy and safety in patients with ADHD. Results are expected in the first quarter of 2024.
In order to meet the pharmacology requirement for the CTx-1301 New Drug Application (NDA) submission, Cingulate completed a food effect study in October of 2022, which demonstrated that CTx-1301 can be taken with or without food.
Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit the NDA for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.
First Quarter Results
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.
Cingulate Inc. | |||||||
Consolidated Balance Sheet Data | |||||||
March 31, | December 31, | ||||||
2023 | 2022 | ||||||
Cash, cash equivalents and short-term investments | $ | 1,738,760 | $ | 5,356,276 | |||
Total assets | $ | 7,162,957 | $ | 11,405,057 | |||
Total liabilities | $ | 7,081,343 | $ | 7,523,035 | |||
Accumulated deficit | $ | (73,413,383 | ) | $ | (69,408,496 | ) | |
Total stockholders' equity | $ | 81,614 | $ | 3,882,022 |
Cingulate Inc. | |||||||
Consolidated Statements of Operations | |||||||
Three Months Ended March 31, | |||||||
2023 | 2022 | ||||||
Operating expenses: | |||||||
Research and development | $ | 2,128,616 | $ | 2,762,284 | |||
General and administrative | 1,721,379 | 2,247,060 | |||||
Operating loss | (3,849,995 | ) | (5,009,344 | ) | |||
Interest and other income (expense), net | (154,892 | ) | 5,833 | ||||
Loss before income taxes | (4,004,887 | ) | (5,003,511 | ) | |||
Income tax benefit (expense) | - | - | |||||
Net loss | (4,004,887 | ) | (5,003,511 | ) | |||
Net loss per share of common stock, basic and diluted | $ | (0.35 | ) | $ | (0.44 | ) |
Investor RelationsThomas DaltonVP, Investor & Public Relations, Cingulate Inc.TDalton@cingulate.com913-942-2301
Matt KrepsDarrow Associatesmkreps@darrowir.com214-597-8200
Media RelationsMelyssa WeibleElixir Health Public Relationsmweible@elixirhealthpr.com201-723-5805
CING-US-123-0524
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