Strategic Commercial Supply Agreement Positions Lead Asset CTx-1301 for Launch Pending FDA ApprovalKANSAS CITY, Kan., Sept. 17, 2025 (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 it has entered into a commercial supply agreement with Bend Bio Sciences for the manufacturing of CTx-1301(dexmethyl ...

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]

Regulatory filing marks significant milestone for medication designed to provide once-daily, entire active-day symptom control in ADHD patients KANSAS CITY, Kan., Aug. 06, 2025 (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 that it has submitted its New Drug Application (NDA) to the U.S. Food an ...

PDUFA Fee Waiver comes Days before Planned Submission of New Drug Application KANSAS CITY, Kan., July 29, 2025 (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, announced today that it has received a fiscal year 2025 PDUFA (Prescription Drug User Fee Act) fee waiver from the U.S. Food and Drug Administration (FDA) ...

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]