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Cingulate Q3 2024 Financials: $19.5M Boost for ADHD Drug Advancement
15 November 2024
Cingulate Inc., a biopharmaceutical firm based in Kansas City, Kansas, reported its financial results for the third quarter of 2024 and provided updates on its clinical and business developments. The company is utilizing its Precision Timed Release (PTR) drug delivery platform to develop next-generation pharmaceutical products.
Shane J. Schaffer, Chairman and CEO of Cingulate, emphasized that the capital raised during the quarter has enabled the company to focus on the remaining activities needed for the New Drug Application (NDA) submission of its lead Attention Deficit Hyperactivity Disorder (ADHD) asset, CTx-1301, targeted for mid-2025. With the grant of European patents for CTx-1301 in up to 30 territories, including the United Kingdom, Cingulate is expanding its reach beyond the United States, positively impacting the growing ADHD markets abroad.
In September, the company initiated its final FDA-required study for CTx-1301, a food effect study. The results from this study are anticipated by the end of 2024. The European patent for CTx-1301, granted in the third quarter of 2024, covers up to 30 territories in Europe, including the United Kingdom. Cingulate also holds patents in Australia, Canada, and Israel, with pending patents in Hong Kong, the Republic of Korea, and the United States.
On September 9, 2024, Cingulate was notified by the Nasdaq Hearings Panel that it had regained compliance with the $1.00 minimum bid price requirement. The company raised approximately $12.5 million in the third quarter of 2024, ensuring the financial runway to support clinical, manufacturing, and regulatory activities into the third quarter of 2025, based on planned expenditures.
As of September 30, 2024, Cingulate had approximately $10 million in cash and cash equivalents, a substantial increase from December 31, 2023. The company also reported $9.8 million in working capital, an increase of $19.5 million from December 31, 2023. Total liabilities as of September 30, 2024, were $1.5 million, a decrease from December 31, 2023, by $8.8 million. This included the conversion of a related party note payable amounting to $3.3 million in the first quarter of 2024. Total stockholders' equity stood at $12.0 million as of September 30, 2024, an increase of $18.9 million from the end of 2023.
Research and development (R&D) expenses for the third quarter of 2024 were $1.4 million, a decrease of $2.5 million from the same period in 2023. This reduction was primarily due to decreased clinical activity compared to the third quarter of 2023, which incurred significant costs for two Phase 3 studies for CTx-1301. The manufacturing costs also declined as the activities in 2023 were more intense for producing clinical supply for the Phase 3 studies. In 2024, manufacturing activities included the completion of registration batches of CTx-1301.
General and administrative (G&A) expenses were $1.9 million for the three months ended September 30, 2024, relatively consistent with the same period in 2023. The net loss for the third quarter of 2024 was $3.2 million, compared to $6.0 million for the same period in 2023. The decrease in net loss was mainly due to the reduction in R&D and G&A expenses.
Cingulate Inc. is dedicated to leveraging its PTR technology to develop pharmaceutical products designed to improve the lives of patients with conditions characterized by challenging daily dosing regimens and suboptimal treatment outcomes. Initially focusing on ADHD treatment, the company is also exploring additional therapeutic areas where its PTR technology can be applied, such as anxiety disorders.
Shane J. Schaffer, Chairman and CEO of Cingulate, emphasized that the capital raised during the quarter has enabled the company to focus on the remaining activities needed for the New Drug Application (NDA) submission of its lead Attention Deficit Hyperactivity Disorder (ADHD) asset, CTx-1301, targeted for mid-2025. With the grant of European patents for CTx-1301 in up to 30 territories, including the United Kingdom, Cingulate is expanding its reach beyond the United States, positively impacting the growing ADHD markets abroad.
In September, the company initiated its final FDA-required study for CTx-1301, a food effect study. The results from this study are anticipated by the end of 2024. The European patent for CTx-1301, granted in the third quarter of 2024, covers up to 30 territories in Europe, including the United Kingdom. Cingulate also holds patents in Australia, Canada, and Israel, with pending patents in Hong Kong, the Republic of Korea, and the United States.
On September 9, 2024, Cingulate was notified by the Nasdaq Hearings Panel that it had regained compliance with the $1.00 minimum bid price requirement. The company raised approximately $12.5 million in the third quarter of 2024, ensuring the financial runway to support clinical, manufacturing, and regulatory activities into the third quarter of 2025, based on planned expenditures.
As of September 30, 2024, Cingulate had approximately $10 million in cash and cash equivalents, a substantial increase from December 31, 2023. The company also reported $9.8 million in working capital, an increase of $19.5 million from December 31, 2023. Total liabilities as of September 30, 2024, were $1.5 million, a decrease from December 31, 2023, by $8.8 million. This included the conversion of a related party note payable amounting to $3.3 million in the first quarter of 2024. Total stockholders' equity stood at $12.0 million as of September 30, 2024, an increase of $18.9 million from the end of 2023.
Research and development (R&D) expenses for the third quarter of 2024 were $1.4 million, a decrease of $2.5 million from the same period in 2023. This reduction was primarily due to decreased clinical activity compared to the third quarter of 2023, which incurred significant costs for two Phase 3 studies for CTx-1301. The manufacturing costs also declined as the activities in 2023 were more intense for producing clinical supply for the Phase 3 studies. In 2024, manufacturing activities included the completion of registration batches of CTx-1301.
General and administrative (G&A) expenses were $1.9 million for the three months ended September 30, 2024, relatively consistent with the same period in 2023. The net loss for the third quarter of 2024 was $3.2 million, compared to $6.0 million for the same period in 2023. The decrease in net loss was mainly due to the reduction in R&D and G&A expenses.
Cingulate Inc. is dedicated to leveraging its PTR technology to develop pharmaceutical products designed to improve the lives of patients with conditions characterized by challenging daily dosing regimens and suboptimal treatment outcomes. Initially focusing on ADHD treatment, the company is also exploring additional therapeutic areas where its PTR technology can be applied, such as anxiety disorders.
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