Cingulate Reports Third Quarter 2024 Financial Results Reflecting $19.5 Million Increase in Working Capital to Advance ADHD Drug to Market
Rhea-AI Summary
Cingulate Inc. reported Q3 2024 financial results, highlighting a $19.5M increase in working capital. The company raised $12.5M in capital during Q3, extending cash runway into Q3 2025. Net loss decreased to $3.2M from $6.0M year-over-year, with R&D expenses dropping to $1.4M from $3.9M. The company secured European patents for its lead ADHD asset CTx-1301 in up to 30 territories and regained Nasdaq compliance. Cingulate remains on track for mid-2025 New Drug Application submission of CTx-1301.
Positive
- Working capital increased by $19.5M from December 2023
- Raised $12.5M in capital during Q3 2024
- Net loss decreased by 46% YoY to $3.2M
- R&D expenses reduced by $2.5M YoY
- Secured European patents for CTx-1301 in up to 30 territories
- Regained Nasdaq compliance with $1.00 minimum bid requirement
Negative
- Accumulated deficit increased to $102.4M
- Operating loss of $3.3M in Q3 2024
- Cash position of $10M may require additional funding beyond Q3 2025
News Market Reaction 1 Alert
On the day this news was published, CINGW gained 46.58%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
On Target for Mid-2025 New Drug Application (NDA) Submission of lead ADHD asset CTx-1301
KANSAS CITY, Kan., Nov. 07, 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 three months ended September 30, 2024, and provided a clinical and business update.
“The capital raised this quarter has allowed us to focus on advancing the remaining activities required for NDA submission of our lead ADHD asset, CTx-1301, targeted for mid 2025,” said Cingulate Chairman and CEO Shane J. Schaffer. “The granting of European patents for CTx-1301 in up to 30 territories, including the United Kingdom, helps Cingulate expand its reach beyond the United States and makes a positive impact on the growing ADHD markets abroad. Overall, Cingulate finds itself in a stronger position financially and looks forward to filing its first NDA next year.”
Cingulate Initiates Final Study for Lead ADHD Asset CTx-1301
In September, Cingulate commenced its final FDA-required study, which is a food effect study, for CTx-1301. A data readout from the study is expected by the end of 2024.
European Patent Granted for Lead Asset CTx-1301 for the Treatment of ADHD
Cingulate was issued a European patent for its lead asset CTx-1301 for the treatment of ADHD during the third quarter of 2024. This patent will include up to 30 European territories, including the United Kingdom. In addition to the European patent, Cingulate has patents in Australia, Canada and Israel, as well as pending patents in Hong Kong, the Republic of Korea, and the United States.
Nasdaq Listing Update
On September 9, 2024, the Nasdaq Hearings Panel notified Cingulate that it had regained compliance with the
Over
Cingulate raised approximately
Third Quarter Results
Cash Position: As of September 30, 2024, Cingulate had approximately
Working Capital: As of September 30, 2024, Cingulate had approximately
Liabilities: As of September 30, 2024, total liabilities were
Stockholders’ Equity: As of September 30, 2024, total stockholders’ equity was
R&D Expenses: R&D expenses were
G&A Expenses: Total G&A expenses were
Net Loss: Net loss was
| Cingulate Inc. | |||||||||
| Consolidated Balance Sheet Data | |||||||||
| September 30, | December 31, | ||||||||
| 2024 | 2023 | ||||||||
| Cash and cash equivalents | $ | 10,040,149 | $ | 52,416 | |||||
| Total assets | $ | 13,580,104 | $ | 3,491,436 | |||||
| Working Capital | $ | 9,801,070 | $ | (9,647,172 | ) | ||||
| Total liabilities | $ | 1,542,541 | $ | 10,360,865 | |||||
| Accumulated deficit | $ | (102,357,201 | ) | $ | (92,943,443 | ) | |||
| Total stockholders' equity | $ | 12,037,563 | $ | (6,869,429 | ) | ||||
| Cingulate Inc. | |||||||||||||||||
| Consolidated Statements of Operations | |||||||||||||||||
| Three Months Ended September 30, | Six Months Ended September 30, | ||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | $ | 1,428,504 | $ | 3,923,852 | $ | 5,116,582 | $ | 10,508,395 | |||||||||
| General and administrative | 1,853,583 | 1,825,822 | 4,319,902 | 5,453,643 | |||||||||||||
| Operating loss | (3,282,087 | ) | (5,749,674 | ) | (9,436,484 | ) | (15,962,038 | ) | |||||||||
| Interest and other income (expense), net | 50,483 | (229,380 | ) | 22,726 | (638,212 | ) | |||||||||||
| Loss before income taxes | (3,231,604 | ) | (5,979,054 | ) | (9,413,758 | ) | (16,600,250 | ) | |||||||||
| Income tax benefit (expense) | - | - | - | - | |||||||||||||
| Net loss | (3,231,604 | ) | (5,979,054 | ) | (9,413,758 | ) | (16,600,250 | ) | |||||||||
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 April 1, 2024 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
FAQ
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