Core Insights - Cingulate Inc. is making significant progress towards the commercial launch of its lead ADHD asset, CTx-1301, with a focus on its Precision Timed Release (PTR) platform designed for once-daily dosing [1][5]. Financial Performance - Cingulate reported $8.9 million in cash and $3.5 million in working capital at the end of 2Q25, which is expected to fund operations into late 2025 [5]. Product Development - The company submitted its New Drug Application (NDA) for CTx-1301 on July 31, 2025, with FDA acceptance anticipated in 4Q25 and a potential PDUFA date in mid-2026 [5]. - Positive results from the Phase 3 pediatric trial and fed/fast study have reinforced CTx-1301's efficacy and flexible dosing capabilities [5]. Commercialization Strategy - Cingulate is actively planning for commercialization in collaboration with Indegene, aiming for a product launch in mid-2026 [5]. - The company is also exploring strategic partnerships to expand its global presence [1].

[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I) [Item 1. Financial Statements](index=5&type=section&id=Item%201%20Financial%20Statements) The unaudited consolidated financial statements show a net loss of $8.6 million for the six months ended June 30, 2025, highlighting the company's pre-revenue status and going concern uncertainty Consolidated Balance Sheet Highlights (unaudited) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $8,900,183 | $12,211,321 | | Total assets | $13,468,208 | $14,864,489 | | Total liabilities | $7,956,334 | $7,408,984 | | Total stockholders' equity | $5,511,874 | $7,455,505 | Consolidated Statements of Operations Highlights (unaudited) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $2,700,939 | $1,881,093 | $4,923,565 | $3,688,078 | | General and administrative | $1,949,035 | $1,325,087 | $3,432,444 | $2,466,319 | | Operating loss | $(4,649,974) | $(3,206,180) | $(8,356,009) | $(6,154,397) | | Net loss | $(4,788,735) | $(3,209,677) | $(8,591,426) | $(6,182,154) | | Net loss per share | $(1.09) | $(5.47) | $(2.14) | $(12.28) | Consolidated Statements of Cash Flows Highlights (unaudited) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,403,539) | $(10,488,400) | | Net cash used in investing activities | $(5,925) | $(154,133) | | Net cash provided by financing activities | $6,098,326 | $10,971,045 | | Net (decrease) increase in cash | $(3,311,138) | $328,512 | [Notes to Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) - The company is a pre-revenue biopharmaceutical firm that has incurred losses since inception, and its **ability to continue as a going concern is in substantial doubt**[23](index=23&type=chunk)[25](index=25&type=chunk) - On December 20, 2024, the company issued an **unsecured promissory note for $5,480,000** to Streeterville Capital, LLC, with an outstanding balance of $5,747,984 as of June 30, 2025[40](index=40&type=chunk)[44](index=44&type=chunk) - The company **submitted the New Drug Application (NDA) for its lead candidate, CTx-1301**, to the FDA on July 31, 2025[71](index=71&type=chunk) - Subsequent to the quarter end, **significant management changes occurred**, including placing the CEO on administrative leave and terminating the COO's employment[71](index=71&type=chunk)[72](index=72&type=chunk) - After the quarter, the company entered a new purchase agreement with Lincoln Park for up to **$25.0 million of common stock** and exchanged $1,225,000 of its promissory note for shares[69](index=69&type=chunk)[70](index=70&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the NDA submission for CTx-1301, a Q2 2025 net loss of $4.8 million, and the substantial doubt about its going concern status due to limited cash reserves - The company is a biopharmaceutical firm using its Precision Timed Release (PTR) drug delivery platform, with an initial focus on ADHD and anxiety treatments[76](index=76&type=chunk) - The **New Drug Application (NDA) for the lead product candidate, CTx-1301, was submitted** to the FDA on July 31, 2025[86](index=86&type=chunk) - **Significant management changes occurred in August 2025**, including placing CEO Shane Schaffer on administrative leave and appointing CFO Jennifer Callahan as interim CEO[81](index=81&type=chunk)[82](index=82&type=chunk) - The company believes its current cash will fund operations into late 2025 and will need to raise an **additional $1.5 million** to advance commercialization efforts into early 2026[79](index=79&type=chunk)[122](index=122&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) The net loss increased to $4.8 million for the quarter and $8.6 million for the six-month period, driven by higher R&D and G&A expenses related to the CTx-1301 NDA submission Comparison of Operating Results (Three Months Ended June 30) | (in thousands) | 2025 | 2024 | Increase | % Increase | | :--- | :--- | :--- | :--- | :--- | | Research and development | $2,701 | $1,881 | $820 | 43.6% | | General and administrative | $1,949 | $1,325 | $624 | 47.1% | | Net Loss | $(4,789) | $(3,209) | $1,580 | 49.2% | Comparison of Operating Results (Six Months Ended June 30) | (in thousands) | 2025 | 2024 | Increase | % Increase | | :--- | :--- | :--- | :--- | :--- | | Research and development | $4,924 | $3,688 | $1,236 | 33.5% | | General and administrative | $3,432 | $2,466 | $966 | 39.2% | | Net Loss | $(8,592) | $(6,182) | $2,410 | 39.0% | [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $8.9 million in cash, sufficient until late 2025, but requires an additional $1.5 million to advance commercialization, raising substantial doubt about its going concern status - The company had **cash and cash equivalents of $8.9 million** as of June 30, 2025[122](index=122&type=chunk) - Capital is being raised through an At-the-Market (ATM) agreement and a Lincoln Park Capital purchase agreement, which **raised net proceeds of $4.2 million in Q2 2025**[120](index=120&type=chunk)[121](index=121&type=chunk) - The company's history of losses and need for additional capital raise **substantial doubt about its ability to continue as a going concern**[133](index=133&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company indicates it has no significant market risk exposure requiring quantitative and qualitative disclosure - The company has determined that quantitative and qualitative disclosures about market risk are **not applicable**[136](index=136&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls during the quarter - Management concluded that the company's **disclosure controls and procedures were effective** as of June 30, 2025[137](index=137&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[138](index=138&type=chunk) [PART II - OTHER INFORMATION](index=35&type=section&id=PART%20II) [Item 1. Legal Proceedings](index=35&type=section&id=Item%201%20Legal%20Proceedings) The company recorded no loss contingencies for legal proceedings but disclosed a reasonably possible contingent bonus plan of $722,824 - The company had **no accrued loss contingencies** for legal proceedings as of June 30, 2025[38](index=38&type=chunk)[139](index=139&type=chunk) - A **contingent bonus plan estimated at $722,824** exists to repay employees for previous salary reductions, but it has not been accrued as payment was not deemed probable[39](index=39&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A%20Risk%20Factors) The company highlights an expanded risk related to retaining key management following recent executive changes, with no other material changes to previously disclosed risks - The company highlights the **risk of failing to attract and retain key management personnel**, citing recent executive changes in August 2025[142](index=142&type=chunk) - Except for the expanded risk factor on key personnel, there were **no other material changes** to the risk factors previously disclosed in the Form 10-K[141](index=141&type=chunk) [Item 5. Other Information](index=36&type=section&id=Item%205%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the second quarter of 2025 - **No director or officer adopted or terminated a Rule 10b5-1 trading arrangement** during the second quarter of 2025[147](index=147&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including governance documents, material agreements, and required certifications - The report lists exhibits filed, including corporate bylaws, material agreements, and required officer certifications[148](index=148&type=chunk)

[Overview and Recent Highlights](index=1&type=section&id=Overview%20and%20Recent%20Highlights) [Key Developments](index=1&type=section&id=Key%20Developments) Cingulate submitted an NDA for CTx-1301, anticipating Q4 2025 FDA acceptance and mid-2026 approval, supported by $25 million equity financing - Submitted a New Drug Application (NDA) to the FDA for its lead asset CTx-1301 for ADHD on **July 31, 2025**[1](index=1&type=chunk)[2](index=2&type=chunk) - Anticipates an FDA decision on NDA acceptance in **Q4 2025**, with a potential Prescription Drug User Fee Act (PDUFA) date in **mid-2026**[1](index=1&type=chunk) - Entered into a 36-month purchase agreement with Lincoln Park Capital for up to **$25.0 million** of common stock, providing opportunistic access to capital[2](index=2&type=chunk)[3](index=3&type=chunk) [Clinical Trial Updates](index=1&type=section&id=Clinical%20Trial%20Updates) Positive Q2 CTx-1301 clinical results from fed/fast and Phase 3 pediatric studies supported the NDA submission - Announced positive top-line results from a **high-dose (50mg) fed/fast study**, demonstrating that CTx-1301 can be administered with or without food[4](index=4&type=chunk) - Results from the **Phase 3 pediatric study** showed a marked improvement of ADHD symptoms at **week five**, highlighting the product's potential benefits[4](index=4&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Cingulate's Q2 2025 net loss increased to $4.8 million due to higher NDA-related expenses, with $8.9 million cash covering operations into late 2025 - Cash and cash equivalents stood at **$8.9 million** as of **June 30, 2025**. The company projects this will satisfy capital needs into **late 2025** and will need to raise an additional **$1.5 million** to advance commercialization efforts into **early 2026**[5](index=5&type=chunk) Quarterly Expense Analysis | Expense Category | Q2 2025 (USD) | Q2 2024 (USD) | Change (%) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $2.7 million | $1.9 million | +43.6% | Increased clinical and regulatory costs for NDA submission | | G&A Expenses | $1.9 million | $1.3 million | +47.1% | Increase in legal and financial advisory fees | | **Net Loss** | **$4.8 million** | **$3.2 million** | **+50.0%** | Primarily due to increased R&D costs | [Consolidated Financial Statements](index=2&type=section&id=Consolidated%20Financial%20Statements) Consolidated financials show declining position and worsening operating results, with Q2 2025 operating loss increasing to $4.6 million due to higher expenses [Consolidated Balance Sheet](index=2&type=section&id=Consolidated%20Balance%20Sheet) Consolidated Balance Sheet Data | Account | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | Cash and cash equivalents | $8,900,183 | $12,211,321 | | Total assets | $13,468,208 | $14,864,489 | | Total liabilities | $7,956,334 | $7,408,984 | | Working Capital | $3,489,921 | $7,688,698 | | Total stockholders' equity | $5,511,874 | $7,455,505 | [Consolidated Statements of Operations](index=3&type=section&id=Consolidated%20Statements%20of%20Operations) Consolidated Statements of Operations Data | Account | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | | :--- | :--- | :--- | | Research and development | $2,700,939 | $1,881,093 | | General and administrative | $1,949,035 | $1,325,087 | | **Operating loss** | **($4,649,974)** | **($3,206,180)** | | **Net loss** | **($4,788,735)** | **($3,209,677)** | [Corporate and Product Information](index=3&type=section&id=Corporate%20and%20Product%20Information) [About CTx-1301 and PTR™ Platform](index=3&type=section&id=About%20CTx-1301%20and%20PTR%E2%84%A2%20Platform) CTx-1301, an ADHD drug on Cingulate's PTR™ platform, provides once-daily dosing with three timed releases for full-day efficacy - CTx-1301 is a multi-core formulation of dexmethylphenidate designed to deliver **three releases of medication** at predefined times to provide rapid onset and entire active-day efficacy from a single tablet[13](index=13&type=chunk) - The PTR™ drug delivery platform uses a proprietary **Erosion Barrier Layer (EBL)** to control drug release at precise, pre-defined intervals[14](index=14&type=chunk) [About ADHD Market](index=3&type=section&id=About%20ADHD%20Market) The ADHD market offers significant opportunity with over 20 million U.S. patients, led by the larger, faster-growing adult segment - ADHD affects over **20 million diagnosed patients** in the U.S., with **12 million adults** and over **8 million under the age of 17**[12](index=12&type=chunk) - Market trends show the **adult ADHD segment is larger and growing faster** than the child and adolescent segments combined[12](index=12&type=chunk) [Company Overview](index=4&type=section&id=Company%20Overview) Cingulate Inc. is a biopharmaceutical company leveraging its PTR™ platform to develop next-gen products, initially focusing on ADHD with plans for anxiety disorders - Cingulate is a biopharmaceutical company using its proprietary **PTR™ platform** to develop products designed to improve the lives of patients with conditions requiring complex daily dosing[15](index=15&type=chunk) - The company's initial focus is on **ADHD**, with plans to evaluate additional therapeutic areas like **anxiety disorders** for future product candidates[15](index=15&type=chunk)

Core Viewpoint - Cingulate Inc. has submitted a New Drug Application (NDA) to the FDA for its lead asset CTx-1301, an innovative ADHD treatment, with an anticipated FDA decision in Q4 2025 and a potential PDUFA date in mid-2026 [1][2][4]. Recent Highlights - The NDA submission for CTx-1301, a novel extended-release tablet formulation of dexmethylphenidate, aims to address limitations of current ADHD therapies by providing fast onset and entire active-day efficacy [2][4]. - Cingulate entered into a purchase agreement with Lincoln Park Capital to purchase up to $25 million of common stock over a 36-month term, allowing the company to manage its capital needs effectively [3][4]. Financial Results - As of June 30, 2025, Cingulate reported approximately $8.9 million in cash and cash equivalents, a decrease of $3.3 million from December 31, 2024, and expects to need an additional $1.5 million to support commercialization efforts for CTx-1301 [5]. - Research and development expenses increased by 43.6% to $2.7 million for the three months ended June 30, 2025, primarily due to costs associated with the NDA submission [6]. - General and administrative expenses rose by 47.1% to $1.9 million for the same period, mainly due to higher legal and financial advisory fees [7]. - The net loss for the three months ended June 30, 2025, was $4.8 million, compared to $3.2 million for the same period in 2024, reflecting increased R&D costs [7]. Product and Technology Overview - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform, designed to deliver dexmethylphenidate in a way that optimizes patient care with a single tablet providing multiple releases throughout the day [15][17]. - The PTR technology incorporates an Erosion Barrier Layer (EBL) that controls drug release at precise times, aiming to improve treatment outcomes for ADHD and potentially other therapeutic areas [17][18]. Market Context - ADHD affects millions, with over 20 million diagnosed in the U.S., including 12 million adults and over 8 million children under 17, indicating a significant market opportunity for effective treatments [14].

Group 1 - Cingulate Inc. has placed its Chairman and CEO, Shane J. Schaffer, on administrative leave due to ongoing legal matters unrelated to the company [2] - Jennifer Callahan, the Chief Financial Officer, has been appointed as the interim CEO to ensure business continuity while retaining her CFO responsibilities [2][4] - Jay Roberts, a board member, has been appointed as Executive Chairman, bringing extensive operational expertise to support the management team [2][3] Group 2 - Cingulate remains committed to its mission of bringing CTx-1301 to patients with ADHD, having submitted a new drug application to the FDA in July [3] - The leadership team has the full confidence of the Board to guide the company forward, emphasizing a commitment to science, innovation, and shareholder value [3] - The executive team supporting Ms. Callahan includes experienced professionals in the ADHD category, such as Dr. Matt Brams, Dr. Raul Silva, and Nilay Patel [5] Group 3 - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary PTR drug delivery platform technology [6] - The company aims to improve treatment outcomes for patients with conditions requiring burdensome daily dosing regimens, initially focusing on ADHD and exploring additional therapeutic areas like anxiety disorders [6]

Core Insights - Cingulate Inc. has submitted a New Drug Application (NDA) to the FDA for CTx-1301, a medication aimed at providing once-daily symptom control for ADHD patients [1][2][3] - CTx-1301 is designed to address limitations of current ADHD therapies by offering fast onset and entire active-day efficacy with a single dose [2][3] - The ADHD market in the U.S. is valued at approximately $23 billion, and Cingulate aims to capture a significant share with CTx-1301 [3] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) drug delivery platform [1][8] - The company is headquartered in Kansas City and is transitioning from a development-stage company to a commercial organization [3][8] Product Details - CTx-1301 is an extended-release tablet formulation of dexmethylphenidate, designed to provide a smooth pharmacokinetic profile and address the need for entire active-day efficacy [2][5] - The medication utilizes a multi-core formulation to deliver three releases of the active ingredient at predefined times, optimizing patient care [5][6] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; the prevalence of adult ADHD is growing faster than that of children and adolescents [4] - In 2022, only 53.6% of children and teens with ADHD were actively treating their symptoms with medication, indicating a substantial unmet need in the market [4] Technology Platform - The PTR™ platform technology includes an Erosion Barrier Layer (EBL) that controls drug release at precise times, allowing for true once-daily dosing [6][7] - Cingulate plans to leverage the PTR technology to develop additional product candidates in other therapeutic areas beyond ADHD [6][8]

Core Insights - Cingulate Inc. has received a PDUFA fee waiver from the FDA for its new drug application for CTx-1301, which is aimed at treating ADHD, saving the company approximately $4.3 million [1][2][3] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) drug delivery platform [1][6] - The company is headquartered in Kansas City and aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens [6][7] Product Information - CTx-1301 is Cingulate's lead candidate, utilizing the PTR platform to deliver dexmethylphenidate in a multi-core formulation designed for optimal patient care [4] - The drug aims to provide a full-day efficacy by releasing medication at three precise intervals, addressing the challenge of maintaining effective treatment throughout the day [4] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; current treatment trends indicate a growing prevalence of adult ADHD [3] - In 2022, only 53.6% of children and teens diagnosed with ADHD were actively treating their symptoms with medication, highlighting a potential market opportunity for effective treatments [3]

As filed with the Securities and Exchange Commission on July 25, 2025 Registration No. 333-288877 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CINGULATE INC. (Primary Standard Industrial Classification Code Number) Delaware 2834 86-3825535 (I.R.S. Employer Identification Number) 1901 W. 47th Place Kansas City, KS 66205 (913) 942-2300 (Address, including zip code, and telephone number, including are ...

Core Insights - Cingulate Inc. has appointed Nilay Patel as Chief Legal Officer as the company prepares to file a new drug application for its ADHD treatment CTx-1301 [1][3] - Patel brings over 20 years of legal and compliance experience in the pharmaceutical industry, having previously held senior roles at Ironshore Pharmaceuticals and Grifols [2][3] - Cingulate's lead candidate, CTx-1301, utilizes the proprietary Precision Timed Release™ (PTR™) platform to optimize ADHD treatment by providing multiple releases of medication throughout the day [6][7] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its PTR drug delivery platform [1][8] - The company aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens, starting with ADHD and potentially expanding to anxiety disorders [8] Product Details - CTx-1301 is designed to deliver dexmethylphenidate in a multi-core formulation, providing a rapid onset and sustained efficacy throughout the day [6] - The drug aims to address the challenge of providing effective treatment for ADHD patients, particularly adults, who often experience persistent symptoms [5][6] Market Context - ADHD affects over 20 million individuals in the U.S., with a significant portion being adults; current treatment options are often inadequate for long-term management [5] - The prevalence of adult ADHD is increasing, indicating a growing market opportunity for effective treatment solutions [5]

Core Insights - Stonegate Capital Partners has initiated coverage on Cingulate Inc. (NASDAQ: CING), highlighting the company's progress towards the commercial launch of its lead ADHD asset, CTx-1301 [1] - CTx-1301 is designed to provide once-daily stimulant therapy with rapid onset and sustained efficacy, addressing limitations of existing ADHD treatments [1] - Cingulate is preparing for commercialization in the U.S. and exploring out-licensing opportunities internationally, targeting a $22 billion U.S. ADHD market [1] Company Developments - Cingulate is on track to submit the New Drug Application (NDA) for CTx-1301 in mid-2025, which will include data from nine clinical trials [5] - Pediatric and high-dose studies have demonstrated strong efficacy, safety, and flexible dosing for CTx-1301 [5] - The company is actively preparing for a U.S. launch and is initiating scale-up plans pending FDA approval [5]