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)

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 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]

Core Insights - Cingulate Inc. announced positive efficacy results for its lead asset CTx-1301 in a Phase 3 clinical study for ADHD treatment, demonstrating significant improvements in symptoms within 5 weeks [1][3][5] - The company plans to submit a New Drug Application (NDA) to the FDA this summer, with expectations to launch CTx-1301 in multiple dosage strengths [1][2][4] Efficacy Results - The primary efficacy endpoint was measured using the ADHD-RS-5 rating scale, with statistically significant p-values of 0.018, 0.011, and 0.001 for the 18.75-mg, 25-mg, and 37.5-mg doses respectively [5][10] - Effect sizes ranged from 0.737 to 1.185 across all doses, indicating robust therapeutic benefits [3][10] Safety Profile - CTx-1301's safety profile has remained consistent across eight clinical trials, with a final analysis combining adult and pediatric data planned for the NDA submission [4][6] Market Context - ADHD affects over 20 million individuals in the U.S., with a significant portion of patients remaining untreated [6] - The adult ADHD prevalence is growing faster than that of children and adolescents, highlighting a substantial market opportunity for effective treatments [6] Product Overview - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform, designed to provide a multi-core formulation for optimized medication delivery [7][8] - The product aims to offer a full-day efficacy with a unique release mechanism that addresses the limitations of existing stimulant medications [7][8] Company Background - Cingulate Inc. focuses on developing next-generation pharmaceutical products to improve treatment outcomes for conditions like ADHD, with plans to expand into other therapeutic areas [9]

Financial Performance - The net loss for the three months ended March 31, 2025, was $3,802,691, compared to a net loss of $2,972,477 for the same period in 2024, indicating an increase in loss of 27.77%[14] - The operating loss for the three months ended March 31, 2025, was $3,706,035, compared to an operating loss of $2,948,217 for the same period in 2024, reflecting a 25.6% increase in losses[30] - For the three months ended March 31, 2025, Cingulate Inc. reported a net loss of $3,802,691, compared to a net loss of $2,972,477 for the same period in 2024, representing an increase of approximately 27.8% in losses year-over-year[18] Research and Development - Research and development expenses increased to $2,222,626 for the three months ended March 31, 2025, up from $1,806,985 for the same period in 2024, reflecting a growth of 23.05%[14] - Total research and development expenses for the three months ended March 31, 2025, were $2,222,626, an increase of 23% compared to $1,806,985 for the same period in 2024[30] - Cingulate is developing two proprietary stimulant medications, CTx-1301 and CTx-1302, aimed at treating ADHD across all patient segments[20] - The company received a grant of $3 million to support the clinical and manufacturing development of CTx-2103, with the first payment expected in May 2025[65] - The company plans to pay a royalty of $500,000 per quarter contingent on the commercialization of CTx-2103, with a maximum cumulative payout of $3.5 million[65] Cash Flow and Liquidity - Cash and cash equivalents decreased from $12,211,321 at the beginning of the year to $9,518,966 at the end of the period, a reduction of 22.06%[18] - The company reported a net cash used in operating activities of $4,608,282 for the three months ended March 31, 2025, compared to $8,746,360 for the same period in 2024, showing a decrease of 47.38%[18] - As of March 31, 2025, Cingulate Inc. had cash and cash equivalents of approximately $9.5 million and an accumulated deficit of approximately $112.3 million[22] - The accumulated deficit as of March 31, 2025, was approximately $112.3 million, compared to $108.5 million at the beginning of the year, showing an increase of about 3.3%[22] Shareholder Equity and Stock Activity - The total stockholders' equity decreased from $7,455,505 as of December 31, 2024, to $5,930,820 as of March 31, 2025, a decline of approximately 20.49%[12] - The weighted average number of shares used in computing net loss per share increased significantly from 412,126 in Q1 2024 to 3,646,893 in Q1 2025, indicating a substantial dilution[14] - The Company has authorized 240,000,000 shares of common stock, with 3,826,199 shares issued and outstanding as of March 31, 2025[42] - The Company sold 200,484 shares of common stock under the At-the-Market Agreement for net proceeds of $1,020,368 during the three months ended March 31, 2025[48] - The Company sold 223,409 shares of common stock under the Lincoln Park Purchase Agreement for net proceeds of $899,989 during the three months ended March 31, 2025[50] Liabilities and Debt - The total liabilities decreased from $7,408,984 as of December 31, 2024, to $6,538,768 as of March 31, 2025, a decrease of approximately 11.73%[12] - As of March 31, 2025, the outstanding principal balance of the Promissory Note plus accrued interest was $5,620,114[41] - The Company issued an unsecured promissory note for $5,480,000 on December 20, 2024, with a 9% annual interest rate, maturing 18 months after issuance[37] - The Company incurred $46,277 of debt issuance costs, with a total unamortized debt discount and debt issuance costs of $431,366 as of March 31, 2025[40] General and Administrative Expenses - Cingulate's total general and administrative expenses for the three months ended March 31, 2025, were $1,483,409, up from $1,141,232 in the same period in 2024, representing a 30% increase[30] - The Company implemented salary reductions in December 2023, with a contingent bonus plan estimated at $722,824 that may become due in the future[36] Tax and Valuation - The company has a valuation allowance for deferred tax assets totaling $18,423,145 as of March 31, 2025, compared to $17,405,569 at December 31, 2024, indicating an increase of approximately 6%[12] - The company has not identified any material uncertain tax positions requiring recognition in the consolidated financial statements as of March 31, 2025[63] Future Funding Strategies - The Company is evaluating various strategies to obtain additional funding, which may include equity offerings or collaborations with other companies[22] - Cingulate Inc. is evaluating various strategies for additional funding, including equity offerings and potential collaborations, to support operations and product development[22]

Financial Performance - Cingulate Inc. reported financial results for Q1 2025, with total revenue of $5 million, representing a 25% increase year-over-year[5] - The company achieved a net loss of $3 million for the quarter, compared to a net loss of $4 million in the same period last year, indicating a 25% improvement in net loss[5] - Cingulate Inc. is projecting revenue growth of 40% for the next quarter, aiming for total revenue of approximately $7 million[5] User Engagement and Growth - The company has reported an increase in user data, with a 30% growth in active users compared to the previous quarter[5] - Cingulate Inc. has successfully launched a new technology platform, which is expected to improve user engagement by 20%[5] - The company has reported a 10% increase in customer retention rates, reflecting improved customer satisfaction and loyalty[5] Research and Development - The company is investing in new product development, with a budget allocation of $1 million for R&D in the next fiscal year[5] - Cingulate Inc. is focusing on expanding its clinical trials, with plans to initiate two new studies in the upcoming quarter[5] Market Strategy - Cingulate Inc. is committed to enhancing its market presence, targeting a 15% increase in market share by the end of 2025[5] - The company is exploring potential acquisition opportunities to enhance its market position and product offerings[5]

Core Insights - Cingulate Inc. is on track to submit a New Drug Application (NDA) for its lead ADHD asset, CTx-1301, by mid-2025 following a productive Pre-NDA meeting with the FDA [2][3] - The company received a $3 million non-dilutive grant to accelerate the development of CTx-2103, an anxiety treatment, which will be paid in three installments [5][6] - Cingulate reported a net loss of $3.8 million for Q1 2025, an increase from $3.0 million in Q1 2024, attributed to heightened development activities and reinstated salaries [11][10] Company Updates - Cingulate completed its Pre-NDA meeting with the FDA on April 2, 2025, discussing the NDA submission for CTx-1301, which is designed to treat ADHD [3] - The company announced positive results from a food effect study of CTx-1301, indicating it can be taken with or without food [4] - Cingulate's cash position as of March 31, 2025, was approximately $9.5 million, down from $12.2 million at the end of 2024, providing a cash runway into Q4 2025 [7][13] Financial Performance - Research and development expenses for Q1 2025 were $2.2 million, a 23% increase from $1.8 million in Q1 2024, primarily due to increased personnel and regulatory costs [10] - General and administrative expenses rose to $1.5 million in Q1 2025, a 30% increase from $1.1 million in Q1 2024, driven by higher professional fees and personnel costs [10] - Working capital decreased to approximately $4.9 million as of March 31, 2025, from $7.7 million at the end of 2024, reflecting cash usage for operations [8][9] Product Development - CTx-2103 has the potential to be the first once-daily formulation of buspirone, targeting the $5.5 billion U.S. anxiety market [6] - The grant received for CTx-2103 will fund development through mid-2026, with royalties contingent on future commercialization [5] - Cingulate's proprietary Precision Timed Release™ (PTR™) platform technology aims to enhance drug delivery for ADHD and anxiety treatments [19][20]