Cingulate Reports Third Quarter 2024 Financial Results Reflecting $19.5 Million Increase in Working Capital to Advance ADHD Drug to Market
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.
Cingulate Inc. ha riportato i risultati finanziari del terzo trimestre 2024, evidenziando un aumento del capitale circolante di $19,5 milioni. L'azienda ha raccolto $12,5 milioni di capitale durante il terzo trimestre, estendendo la disponibilità di cassa fino al terzo trimestre del 2025. La perdita netta è diminuita a $3,2 milioni rispetto ai $6,0 milioni dell'anno precedente, con le spese per ricerca e sviluppo che sono scese a $1,4 milioni dai $3,9 milioni. L'azienda ha ottenuto brevetti europei per il suo principale asset per l'ADHD, CTx-1301, in fino a 30 territori e ha ripristinato la conformità con il Nasdaq. Cingulate rimane in linea per la presentazione della domanda di nuovo farmaco per CTx-1301 a metà del 2025.
Cingulate Inc. informó los resultados financieros del tercer trimestre de 2024, destacando un incremento de $19.5 millones en capital de trabajo. La empresa recaudó $12.5 millones en capital durante el tercer trimestre, extendiendo su liquidez hasta el tercer trimestre de 2025. La pérdida neta disminuyó a $3.2 millones desde $6.0 millones en comparación con el año anterior, con los gastos de I+D cayendo a $1.4 millones desde $3.9 millones. La compañía aseguró patentes europeas para su principal activo contra el TDAH, CTx-1301, en hasta 30 territorios y recuperó la conformidad con Nasdaq. Cingulate sigue en camino para la presentación de la solicitud de nuevo medicamento de CTx-1301 a mediados de 2025.
Cingulate Inc.는 2024년 3분기 재무 결과를 발표하며 운전 자본이 $1950만 증가했다고 밝혔습니다. 회사는 3분기 동안 $1250만을 자본 조달하여 2025년 3분기까지 현금 경과 시간을 연장했습니다. 순손실은 전년 대비 $600만에서 $320만으로 감소하였으며, 연구 및 개발 비용은 $390만에서 $140만으로 줄었습니다. 회사는 주요 ADHD 치료 자산 CTx-1301에 대해 최대 30개 지역에 대한 유럽 특허를 확보하였고 Nasdaq 준수를 되찾았습니다. Cingulate는 2025년 중반에 CTx-1301에 대한 새로운 약물 신청서를 제출할 계획을 유지하고 있습니다.
Cingulate Inc. a annoncé les résultats financiers du troisième trimestre 2024, mettant en évidence une augmentation de 19,5 millions de dollars du fonds de roulement. L'entreprise a levé 12,5 millions de dollars de capital durant le troisième trimestre, prolongeant ainsi sa capacité financière jusqu'au troisième trimestre 2025. La perte nette a diminué à 3,2 millions de dollars contre 6,0 millions de dollars l'année précédente, avec des dépenses de R&D en baisse à 1,4 million de dollars contre 3,9 millions de dollars. L'entreprise a obtenu des brevets européens pour son principal produit contre le TDAH, CTx-1301, dans jusqu'à 30 territoires et a retrouvé sa conformité avec le Nasdaq. Cingulate reste sur la bonne voie pour soumettre une demande de nouveau médicament pour CTx-1301 à la mi-2025.
Cingulate Inc. hat die finanziellen Ergebnisse des dritten Quartals 2024 veröffentlicht und ein Plus von 19,5 Millionen Dollar im Umlaufvermögen hervorgehoben. Das Unternehmen hat im dritten Quartal 12,5 Millionen Dollar an Kapital aufgenommen und damit die Liquidität bis ins dritte Quartal 2025 verlängert. Der Nettoverlust sank auf 3,2 Millionen Dollar gegenüber 6,0 Millionen Dollar im Vorjahr, während die F&E-Ausgaben auf 1,4 Millionen Dollar von 3,9 Millionen Dollar zurückgingen. Das Unternehmen sicherte sich europäische Patente für sein führendes ADHD-Produkt CTx-1301 in bis zu 30 Territorien und stellte die Nasdaq-Konformität wieder her. Cingulate bleibt auf Kurs für die Einreichung des Antrags auf ein neues Medikament für CTx-1301 Mitte 2025.
- 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
- 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
Insights
The Q3 results reveal significant financial improvements for Cingulate. The company strengthened its balance sheet with
The extended cash runway into Q3 2025 aligns with the planned mid-2025 NDA submission for CTx-1301. The reduction in total liabilities by
The advancement of CTx-1301 toward NDA submission represents a important milestone in the ADHD treatment landscape. The completion of Phase 3 trials and ongoing food effect study demonstrate systematic progress in the regulatory pathway. The expanded patent protection across 30 European territories, plus existing patents in Australia, Canada and Israel, significantly enhances the commercial potential of CTx-1301.
The company's Precision Timed Release™ technology could address current limitations in ADHD medication delivery. With the final FDA-required study underway and data expected by year-end, the mid-2025 NDA submission timeline appears realistic and well-supported by completed clinical work.
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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