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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
November 7, 2025
CINGULATE INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-40874 | 86-3825535 | ||
| (State or other jurisdiction | (Commission | (IRS Employer | ||
| of incorporation) | File Number) | Identification No.) |
1901 W. 47th Place
Kansas City, KS 66205
(Address of principal executive offices) (Zip Code)
(913) 942-2300
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of exchange on which registered | ||
| Common Stock, par value $0.0001 per share | CING |
The Nasdaq Stock Market LLC (Nasdaq Capital Market) |
||
| Warrants, exercisable for one share of common stock | CINGW |
The Nasdaq Stock Market LLC (Nasdaq Capital Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.01. Entry into a Material Definitive Agreement.
On November 7, 2025, Cingulate, Inc. (the “Company”), entered into a Note Purchase Agreement (the “Note Purchase Agreement”) with Avondale Capital, LLC, a Utah limited liability company (“Lender”), pursuant to which the Company issued and sold to Lender an unsecured promissory note (the “Note”) in the amount of $6,570,000 (the “Principal Amount”). The Principal Amount includes an original issue discount of $540,000. In exchange for the Note, Lender paid a purchase price of $6,000,000 in cash (the “Purchase Price”). The Note bears interest at a rate of 9% per annum and matures 18 months after its issuance date. The Company intends to use the net proceeds from the sale of the Note for working capital and other general corporate purposes.
The Company’s wholly-owned subsidiaries Cingulate Therapeutics LLC and Cingulate Works, Inc., provided a guarantee (the “Guaranty”) of the Company’s obligations to Lender under the Note and the other transaction documents.
From time to time, beginning on May 7, 2026, Lender may redeem a portion of the Note, not to exceed an amount of $660,000 per month; provided, that, prior to the Company’s receipt of a “complete response letter” from the U.S. Food and Drug Administration, the Company may defer up to two redemptions for up to thirty (30) days each. If the Company exercises its deferral right, the outstanding balance of the Note will be increased by 1% of the outstanding balance on the date of the deferral. In the event the Note is outstanding on the 90-day anniversary of the effective date of the Note, the Company will be charged a monitoring fee equal to the outstanding balance on such date divided by 0.85 less the outstanding balance on such date. Subject to the terms and conditions set forth in the Note, the Company may prepay all or any portion of the outstanding balance of the Note at any time.
The Note provides for customary events of default (each as defined in the Note, an “Event of Default”), including, among other things, the event of nonpayment of principal, interest, fees or other amounts, a representation or warranty proving to have been incorrect when made, failure to perform or observe covenants within a specified cure period, a cross-default to certain other indebtedness and material agreements of the Company, and the occurrence of a bankruptcy, insolvency or similar event affecting the Company. Upon the occurrence of an Event of Default that is deemed a “Major Trigger Event” as defined in the Note, Lender may increase the outstanding balance of the Note by 15%, and upon the occurrence of an Event of Default that is deemed a “Minor Trigger Event” as defined in the Note, Lender may increase the outstanding balance of the Note by 5%. Lender can exercise its right to increase the outstanding balance upon a Major or Minor Trigger Event three times each. Upon the occurrence of an Event of Default, Lender may declare all amounts owed under the Note immediately due and payable. In addition, upon the occurrence of an Event of Default, upon the election of Lender, interest shall begin accruing on the outstanding balance of the Note from the date of the Event of Default equal to the lesser of 22% per annum and the maximum rate allowable under law.
Pursuant to the Note Purchase Agreement, while the Note is still outstanding, the Company will not enter into any arrangement that prohibits the Company from entering into a variable rate transaction, as defined in the Note Purchase Agreement, with Lender or its affiliates, or from issuing securities of the Company to Lender or its affiliates. The Company is also prohibited from entering into a variable rate transaction while the Note is outstanding, subject to certain exceptions. At any time while the Note is still outstanding, Lender will have the right, but not the obligation, with the Company’s consent, to reinvest up to an additional $5,000,000 in the Company in one or more tranches on the same terms and conditions as the Note. Additionally, so long as the Note is outstanding, upon any issuance by the Company of any debt security with any economic term or condition more favorable to the holder of such security that was not provided to Lender pursuant to the Note, then, at Lender’s option, such additional term shall become part of the Note and related documents for the benefit of Lender.
The Note Purchase Agreement also provides for indemnification of Lender and its affiliates in the event that they incur loss or damage related to, among other things, a breach by the Company of any of its representations, warranties or covenants under the Note Purchase Agreement.
The description of the Note Purchase Agreement, the Note and the Guaranty is qualified in its entirety by the full text of the Note Purchase Agreement, the Note and the Guaranty, copies of which are filed herewith as Exhibits 10.1, 4.1 and 10.2, respectively, and which are incorporated herein by reference.
Item 2.03. Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.
To the extent required by Item 2.03 of Form 8-K, the information contained in Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference.
Item 7.01. Regulation FD Disclosure.
On November 10, 2025, the Company issued a press release announcing the Note and the appointment of Bryan Downey as the Company’s Chief Commercial Officer. A copy of the press release is furnished as Exhibit 99.1 hereto and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 4.1 | Promissory Note issued to Avondale Capital, LLC, dated November 7, 2025 | |
| 10.1 | Note Purchase Agreement between Cingulate Inc. and Avondale Capital, LLC, dated November 7, 2025 | |
| 10.2 | Guaranty by Cingulate Therapeutics LLC and Cingulate Works, Inc., dated November 7, 2025 | |
| 99.1 | Press Release, dated November 10, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CINGULATE INC. | ||
| Dated: November 10, 2025 | By: | /s/ Jennifer L. Callahan |
| Name: | Jennifer L. Callahan | |
| Title: | Interim Chief Executive Officer and Chief Financial Officer |
|
Exhibit 4.1
Exhibit 10.1
Exhibit 10.2
Exhibit 99.1
Cingulate Names Industry Veteran Bryan Downey Chief Commercial Officer to Lead Launch Preparation for CTx-1301
Appointment builds on recent FDA acceptance of New Drug Application for review and advances Cingulate’s transition toward commercialization pending FDA approval
Company also strengthens its cash position by completing a $6 million financing
KANSAS CITY, Kan., Nov.10, 2025 — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform, today announced the appointment of Bryan Downey as Chief Commercial Officer, following the U.S. Food and Drug Administration’s (FDA) acceptance of Cingulate’s New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl) and assignment of a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026.
Cingulate also announced it has completed a $6 million financing transaction, further strengthening its balance sheet and extending its cash runway into the second quarter of 2026, as the company prepares for commercialization, subject to FDA approval.
“Bryan’s appointment represents an important step in Cingulate’s evolution,” said Jay Roberts, Executive Chairman. “His experience driving successful product launches and organizational growth will be instrumental as we execute a disciplined, capital-efficient strategy to bring CTx-1301 to market, pending FDA approval. In parallel, this latest financing meaningfully extends our cash runway, providing the resources needed to advance launch readiness activities and position Cingulate for a successful commercialization phase.”
Downey brings more than 25 years of experience in commercial strategy, leadership, and business transformation, including a proven record of successful pharmaceutical product launches. He has held senior executive roles at Alfasigma USA and Jubilant Pharma, leading commercial operations and product commercialization efforts, and spent nearly two decades at Sanofi, where he served as Vice President and Head of the U.S. Cardiovascular and Allergy Business Unit. There, he oversaw multiple product launches and brand strategies across diverse therapeutic areas.
Most recently, Downey served as Managing Director in CRA | Admired Leadership’s Leadership Advisory Practice, where he advised Fortune 100 and biopharma executives on leadership, strategy, and organizational excellence.
“Cingulate is at a pivotal moment as we prepare to bring CTx-1301 to market,” said Bryan Downey, Chief Commercial Officer. “The potential to deliver rapid onset and entire active-day ADHD symptom control in one daily dose is a substantial differentiator from medications currently available. With our new drug application now accepted for review, we’re working closely with our partners at Indegene to establish the commercial infrastructure, market access execution, and launch readiness that will position CTx-1301 for success.”
Cingulate has partnered with Indegene, a digital-first life sciences commercialization company, to prepare for the potential launch of CTx-1301, pending FDA approval. This commercial strategy combines a Cingulate-led approach with Indegene’s AI-driven, data-rich platform designed to optimize prescriber reach, payer access, and patient support.The global ADHD market exceeds $23 billion annually, yet many patients still struggle with inconsistent symptom control or the need for multiple daily doses. Cingulate’s Precision Timed Release™ (PTR™) platform aims to solve this challenge by enabling three timed releases of medication from a single tablet—designed to maintain focus and attention across the entire active day.
On November 3, 2025, the Company granted non-qualified stock options to Bryan Downey to purchase a total of 30,000 shares of the Company’s common stock at an exercise price per share of $3.80, which was the closing price per share of the Company’s common stock as reported by NASDAQ on November 3, 2025. The grant was approved by the Compensation Committee of the Company’s Board of Directors as an inducement award in accordance with Nasdaq Listing Rule 5635(c)(4). The options will vest over four years, with 25% of the shares underlying the option vesting on the one-year anniversary of the grant date and the remaining 75% vesting in approximately equal monthly installments over the following thirty-six months, subject to the employee being continuously employed by the Company through each vesting date.
Financing Overview
In conjunction with the leadership appointment, Cingulate completed a financing transaction with an accredited investor, providing net proceeds of $6 million. The transaction was structured as a $6,570,000 non-convertible, unsecured promissory note accruing interest at 9% per annum and maturing 18 months from issuance. The note provides the flexibility for Cingulate to begin monthly redemptions on the note subsequent to the CTx-1301 PDUFA date of May 31, 2026. Cingulate intends to use the proceeds for working capital and other general corporate purposes.
The offer and sale of the promissory note was made by Cingulate Inc. in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended, and/or Regulation D promulgated thereunder, and such securities have not been registered under the Act or applicable state securities laws.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
About Attention-Deficit/Hyperactivity Disorder (ADHD)
ADHD is a chronic neurodevelopmental disorder affecting an estimated 20 million individuals in the U.S., including approximately 8 million children and 12 million adults. The condition is characterized by inattention, hyperactivity, and impulsivity that impair academic, professional, and social functioning. Stimulant medications remain the gold-standard therapy; however, most currently available extended-release formulations require multiple doses per day and often fail to provide consistent coverage across the entire active day.
About CTx-1301
CTx-1301 (dexmethylphenidate HCI) is a once-daily, multi-core tablet utilizing Cingulate’s proprietary Precision Timed Release™ (PTR™) platform to deliver three precisely timed releases of active medication across the day. This design aims to provide rapid onset of effect and entire active-day duration. CTx-1301 is being evaluated for the treatment of ADHD under the FDA’s 505(b)(2) pathway. In October 2025, Cingulate announced that the U.S. Food and Drug Administration (FDA) had accepted for review the New Drug Application (NDA) for CTx-1301 and had assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. NDA acceptance signifies that the FDA has determined the submission is sufficiently complete to permit substantive review. NDA acceptance does not imply approval, nor does it guarantee any specific outcome or timing.
About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING) is a biopharmaceutical company utilizing its proprietary Precision Timed Release™ platform technology to build and advance a pipeline of next-generation pharmaceutical products designed to improve patient outcomes in conditions characterized by burdensome daily dosing and suboptimal therapeutic coverage. Cingulate’s lead candidate, CTx-1301, is in late-stage development for ADHD, with additional candidates in anxiety and other neuropsychiatric indications. Cingulate is headquartered in Kansas City, Kansas. 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, the potential approval and commercialization of CTx-1301, financing transactions, cash runway, 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 & Media Contact
Thomas Dalton, Vice President, Corporate Communications
Cingulate Inc.
Email: tdalton@cingulate.com | Phone: (913) 942-2301