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Earnings documents stored for CING.
Investor releaseQuarter not tagged2026-08-19CING: Second Quarter Results
Zacks Small Cap Research
CING: Second Quarter Results
By John Vandermosten, CFA NASDAQ: CING READ THE FULL CING RESEARCH REPORT Cingulate, Inc. (NASDAQ: CING) reported second quarter 2026 results on August 13th, 2026. During the three-month period, the company generated no revenue and recorded operating expense of $5.4 million. Since the end of the first quarter, cash balances have increased from accessing the at-the-market (ATM) and Lincoln Park facilities. To keep investors apprised of the company’s latest efforts, CEO Shane Schaffer participates in a video series. He breaks down the details behind the Complete Response Letter (CRL), outlines the next steps in the resubmission process, and provides his insight on news and events in the Attention-Deficit/Hyperactivity Disorder (ADHD) space. In the operational realm, earlier this year it became apparent that the FDA would issue a CRL for CTx-1301 due to specific Chemistry, Manufacturing, and Controls (CMC) information requests. Management believes that the issues will be resolved and noted that no clinical safety or efficacy concerns were identified in the CRL. The company is working with Bend Bioscience to complete the requested CMC work and advance process validation for CTx-1301. The resulting drug product would serve as launch inventory if approved. The company also signed an agreement with Prasco, who will help support the distribution of CTx-1301 post-approval. As it traverses the regulatory process, Cingulate will maintain its focus on pricing, reimbursement, market access, and patient assistance activities during the pre-commercialization period. Management believes that it can maintain its anticipated 1H:27 launch of CTx-1301. 2Q:26 Financial and Operational Results Cingulate reported 2Q:26 results in a press release and Form 10-Q filing with the SEC on August 13th. For the quarter ended June 30th, 2026, the company reported a net loss of $5.9 million or $0.45 per share. For 2Q:26 versus the same prior year period: Research and development expenses were $1.5 million, down 44% from $2.7 million. The change was attributable to lower clinical operations costs as clinical study activities concluded in early 2025 in connection with preparing the CTx-1301 NDA. These trends were partially offset by a rise in personnel expenses; Selling, general & administrative expenses rose 102% to $3.9 million from $1.9 million on account of spending on commercial readiness…Read full documentShow less
By John Vandermosten, CFA NASDAQ: CING READ THE FULL CING RESEARCH REPORT Cingulate, Inc. (NASDAQ: CING) reported second quarter 2026 results on August 13th, 2026. During the three-month period, the company generated no revenue and recorded operating expense of $5.4 million. Since the end of the first quarter, cash balances have increased from accessing the at-the-market (ATM) and Lincoln Park facilities. To keep investors apprised of the company’s latest efforts, CEO Shane Schaffer participates in a video series. He breaks down the details behind the Complete Response Letter (CRL), outlines the next steps in the resubmission process, and provides his insight on news and events in the Attention-Deficit/Hyperactivity Disorder (ADHD) space. In the operational realm, earlier this year it became apparent that the FDA would issue a CRL for CTx-1301 due to specific Chemistry, Manufacturing, and Controls (CMC) information requests. Management believes that the issues will be resolved and noted that no clinical safety or efficacy concerns were identified in the CRL. The company is working with Bend Bioscience to complete the requested CMC work and advance process validation for CTx-1301. The resulting drug product would serve as launch inventory if approved. The company also signed an agreement with Prasco, who will help support the distribution of CTx-1301 post-approval. As it traverses the regulatory process, Cingulate will maintain its focus on pricing, reimbursement, market access, and patient assistance activities during the pre-commercialization period. Management believes that it can maintain its anticipated 1H:27 launch of CTx-1301. 2Q:26 Financial and Operational Results Cingulate reported 2Q:26 results in a press release and Form 10-Q filing with the SEC on August 13th. For the quarter ended June 30th, 2026, the company reported a net loss of $5.9 million or $0.45 per share. For 2Q:26 versus the same prior year period: Research and development expenses were $1.5 million, down 44% from $2.7 million. The change was attributable to lower clinical operations costs as clinical study activities concluded in early 2025 in connection with preparing the CTx-1301 NDA. These trends were partially offset by a rise in personnel expenses; Selling, general & administrative expenses rose 102% to $3.9 million from $1.9 million on account of spending on commercial readiness planning for the potential launch of CTx-1301, including increased headcount and market access, pricing, reimbursement, and medical affairs activities conducted through Indegene. Occupancy, insurance, and other expenses fell; Net interest and other expenses were $141,000 vs $139,000 related to interest payments for the note with Avondale, partially offset by interest income; Other expense of $314,000 related to the change in the fair value of derivatives related to the LP purchase agreement with Lincoln Park; Net loss was $5.9 million vs $5.0 million, or $0.45 and $1.14 per share, respectively. As of June 30th, 2026, cash totaled $28.4 million. This amount compares to the $11.0 million cash balance held at the end of 2025. Cash burn for the first six months of 2026 was $12.9 million, more than offset by $30.4 million in financing cash contributions from the issuance of common stock and sales from the ATM sales agreement, offset by principal payments on notes payable. Following the end of the second quarter, Cingulate raised an additional $1.4 million from the ATM and $1.1 million from the Lincoln Park arrangement. Also following quarter end, Cingulate extinguished $1.3 million of principal for 140,000 shares of common stock along with a $600,000 cash payment related to the promissory note with Avondale. Cingulate management believes it holds sufficient capital to fund operations into mid-2027, including the costs of seeking regulatory approval for CTx-1301 and the build-out of internal and external support for the commercial launch of CTx-1301. Key Patent Issued On June 16th, 2026, the US Patent and Trademark Office issued patent #12,653,791 to Cingulate, entitled Trimodal, Precision-Timed Pulsatile Release Tablet. The intellectual property includes claims for composition-of-matter, formulation, structural, and method-of-treatment. It protects these critical aspects of Cingulate’s work through December 2042. CTx-1301 FDA Submission Timeline and Commercial Launch Following the July 2025 New Drug Application (NDA) submission and the October 2025 FDA acceptance of the NDA, the agency assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. In the 2025 Form 10-K filed in March 2026, Cingulate reported that its manufacturing partner was issued a Form 483[1] by the FDA following a February 2026 facility inspection, which yielded three observations. Two observations were related to the CDMO’s facility, and one observation was specific to CTx-1301. The CMC issues ultimately led to the issuance of a Complete Response Letter (CRL) for CTx-1301. Cingulate must resubmit its NDA after the observations at the manufacturer have been addressed. Management has emphasized that it will be able to maintain its 1H:27 target for launch of CTx-1301. Management Interview CEO Shane Schaffer participated in a video interview where he discussed near-term milestones for Cingulate, how CTx-1301 changes ADHD treatment, and some of the larger trends impacting the space. Access the videos in the series using the links below. Complete Response Letter ADHD Medicine Shortage CTx-1301 Labeling Cingulate Resubmission Prasco Arrangement On July 21st, 2026, Cingulate signed an exclusive services agreement with Prasco, LLC to establish the commercial distribution infrastructure for the commercialization of CTx-1301. Prasco is based in Mason, Ohio, and assists companies commercialize products in the US market and manage them post-launch. Some of the core services Prasco provides are private label commercialization, distribution & logistics, warehousing & supply chain, market access using its Unlimit network and specialty logistics partnerships, among other services. This partner can be useful for a small biotech company that lacks its own sales and distribution network. Cingulate notes in the 10-Q filing that Prasco has direct distribution to approximately 19,000 independent and small regional pharmacy accounts. Milestones Close of $12 million private placement – February 2026 FDA pre-approval inspection of Gainesville facility – February 2026 FDA issues CRL for CTx-1301 citing CMC – June 2026 USPTO issuance of US Patent #12,653,791 – June 2026 Cingulate added to Russell 3000E – July 2026 Exclusive service agreement with Prasco – July 2026 CTx-1301 anticipated launch – 1H:27 SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE. ________________________ [1] An FDA Form 483, or inspectional observation, is a document issued at the conclusion of an FDA inspection when investigators find conditions that may violate Food, Drug and Cosmetic (FD&C) Act regulations. It highlights potential deficiencies in procedures, equipment, or processes, requiring a written response and corrective action plan.
Investor releaseQuarter not tagged2026-08-13Cingulate Inc. Reports Second Quarter 2026 Financial Results and Provides Update on CTx-1301 CMC Progress Towards NDA Resubmission and Commercial Readiness
GlobeNewswire
Cingulate Inc. Reports Second Quarter 2026 Financial Results and Provides Update on CTx-1301 CMC Progress Towards NDA Resubmission and Commercial Readiness
Cash and Cash Equivalents of $28.4 Million as of June 30, 2026 Providing Runway Through Mid-2027; Company Advances Chemistry, Manufacturing and Controls (CMC) Work Toward NDA Resubmission KANSAS CITY, Kan., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today reported financial results for the quarter ended June 30, 2026, and provided a corporate update. “While the regulatory process continues, our priorities remain clear: complete the remaining manufacturing work, submit a comprehensive response to the FDA, and continue preparing the organization for commercialization,” said Cingulate Chairman and CEO Shane J. Schaffer. “We believe CTx-1301 has the potential to address a significant unmet need in ADHD treatment, and we remain committed to bringing this innovative therapy to patients as quickly as possible, pending FDA approval.” Regulatory Update: CTx-1301 NDA Resubmission Progress Cingulate continues to make progress on the CMC work needed to support resubmission of the NDA for CTx-1301 (dexmethylphenidate HCl), its lead ADHD asset. The Company is working closely with its manufacturing partner to complete this work and plans to resubmit the NDA to the FDA as promptly as practicable. This work follows a Complete Response Letter issued by the FDA on June 1, 2026, which identified specific requests for additional CMC information and did not identify any concerns regarding the clinical safety or efficacy of CTx-1301. Intellectual Property Update On June 16, 2026, the U.S. Patent and Trademark Office issued U.S. Patent No. 12,653,791 covering CTx-1301, following a Notice of Allowance issued on March 17, 2026. The patent, titled “Trimodal, Precision-Timed Pulsatile Release Tablet,” includes composition-of-matter, formulation, structural and method-of-treatment claims and protects key aspects of CTx-1301’s formulation and method of use through December 2042. This is the first U.S. patent wholly owned by Cingulate covering CTx-1301, further strengthening the Company’s intellectual property portfolio surrounding its PTR platform. Commercial Readiness Update Cingulate continues to advance commercialization preparations for CTx-1301, contingent upon FDA approval. Current activity is concentra…Read full documentShow less
Cash and Cash Equivalents of $28.4 Million as of June 30, 2026 Providing Runway Through Mid-2027; Company Advances Chemistry, Manufacturing and Controls (CMC) Work Toward NDA Resubmission KANSAS CITY, Kan., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today reported financial results for the quarter ended June 30, 2026, and provided a corporate update. “While the regulatory process continues, our priorities remain clear: complete the remaining manufacturing work, submit a comprehensive response to the FDA, and continue preparing the organization for commercialization,” said Cingulate Chairman and CEO Shane J. Schaffer. “We believe CTx-1301 has the potential to address a significant unmet need in ADHD treatment, and we remain committed to bringing this innovative therapy to patients as quickly as possible, pending FDA approval.” Regulatory Update: CTx-1301 NDA Resubmission Progress Cingulate continues to make progress on the CMC work needed to support resubmission of the NDA for CTx-1301 (dexmethylphenidate HCl), its lead ADHD asset. The Company is working closely with its manufacturing partner to complete this work and plans to resubmit the NDA to the FDA as promptly as practicable. This work follows a Complete Response Letter issued by the FDA on June 1, 2026, which identified specific requests for additional CMC information and did not identify any concerns regarding the clinical safety or efficacy of CTx-1301. Intellectual Property Update On June 16, 2026, the U.S. Patent and Trademark Office issued U.S. Patent No. 12,653,791 covering CTx-1301, following a Notice of Allowance issued on March 17, 2026. The patent, titled “Trimodal, Precision-Timed Pulsatile Release Tablet,” includes composition-of-matter, formulation, structural and method-of-treatment claims and protects key aspects of CTx-1301’s formulation and method of use through December 2042. This is the first U.S. patent wholly owned by Cingulate covering CTx-1301, further strengthening the Company’s intellectual property portfolio surrounding its PTR platform. Commercial Readiness Update Cingulate continues to advance commercialization preparations for CTx-1301, contingent upon FDA approval. Current activity is concentrated on market access, payer readiness and manufacturing, the workstreams that must be advanced furthest ahead of any launch. Key areas of focus include: Commercial Manufacturing: Working with Bend Bioscience, the Company’s contract development and manufacturing organization, to complete the requested CMC work and advance process validation for CTx-1301, which would serve as launch inventory if approved. Product Distribution: On July 21, 2026, the Company signed an exclusive services agreement with Prasco, LLC to establish the commercial distribution infrastructure for the launch of CTx-1301, providing integrated third-party logistics and distribution capabilities designed to support broad national availability across major wholesalers as well as direct distribution to approximately 19,000 independent and smaller regional pharmacy accounts served under Prasco's UNLIMIT program. Market Access and Payer Strategy: Advancing payer segmentation, value proposition, pricing and contracting strategy, and to support formulary positioning ahead of a potential launch. Commercial Operations and Omnichannel Infrastructure: Building marketing, commercial operations and digital capabilities through the Company’s master services agreement with Indegene, Inc., including dedicated market access, medical education, agency of record, and prescriber and patient marketing teams. Field Deployment Planning: Under its agreement with IQVIA Inc., the Company will deploy field-based sales representatives in addition to its currently deployed corporate account directors to align with the timing of a potential approval and launch. Second Quarter and First Half 2026 Financial Results Cash and Working Capital: As of June 30, 2026, Cingulate had approximately $28.4 million in cash and cash equivalents, compared to $11.0 million as of December 31, 2025. The increase was primarily driven by capital raised in the first and second quarters, including the close of a $12.0 million private placement in the first quarter and $19.0 million of capital raised on Cingulate’s At-the-Market Agreement with AGP and Purchase Agreement with Lincoln Park Capital, offset by $12.8 million in cash used for operations. Cingulate had approximately $21.6 million in working capital as of June 30, 2026, an increase of $19.9 million as compared to December 31, 2025. Under its current business plan, the Company believes its cash and cash equivalents will be sufficient to fund operations into mid-2027, including costs associated with completing the requested CMC work, seeking regulatory approval for CTx-1301, and continuing the build-out of commercial readiness capabilities. R&D Expenses: Research and development (R&D) expenses were $1.5 million for the three months ended June 30, 2026, a decrease of 44.9% from $2.7 million for the three months ended June 30, 2025, driven primarily by lower clinical operations costs following the conclusion of clinical study activities in early 2025 and the absence of the increased regulatory costs incurred in the prior-year period in connection with preparing the CTx-1301 NDA. For the six months ended June 30, 2026, R&D expenses were $3.7 million, a decrease of 25.4% from $5.0 million for the six months ended June 30, 2025, partially offset by increased manufacturing activities and personnel costs in the first half of 2026. SG&A Expenses: Selling, general and administrative (SG&A) expenses were $3.9 million for the three months ended June 30, 2026, compared to $1.9 million for the three months ended June 30, 2025, an increase of 101.5%. For the six months ended June 30, 2026, SG&A expenses were $9.7 million, compared to $3.4 million for the six months ended June 30, 2025, an increase of 181.7%. The increases were driven primarily by the build-out of commercial readiness capabilities, including increased headcount and expanded market access, pricing, reimbursement and medical affairs activity conducted through Indegene, the Company’s commercialization partner. Net Loss: Net loss was $5.9 million for the three months ended June 30, 2026, compared to $5.0 million for the three months ended June 30, 2025. For the six months ended June 30, 2026, net loss was $15.2 million, compared to $8.8 million for the six months ended June 30, 2025, primarily reflecting the increase in SG&A expenses described above. About Attention Deficit/Hyperactivity Disorder (ADHD) ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The estimated market size of the US ADHD market is approximately 100 million annual prescriptions. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined. About CTx-1301 CTx-1301 (dexmethylphenidate HCl) 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, the FDA accepted for review the NDA for CTx-1301 and assigned a PDUFA target action date of May 31, 2026. On June 1, 2026, the FDA issued a Complete Response Letter for the CTx-1301 NDA; the Company is working to complete the requested CMC work and plans to resubmit the NDA as promptly as practicable. There can be no assurance regarding the timing of any resubmission or whether approval will occur. About Precision Timed Release™ (PTR™) Platform Technology Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD. About Cingulate Inc. Cingulate Inc. (NASDAQ: CING) is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. 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, the timing and outcome of any resubmission of the CTx-1301 NDA, market opportunity, competitive position, business strategies, potential growth opportunities, our expected cash runway, and anticipated capital needs and financing plans. 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 18, 2026, our Quarterly Report on Form 10-Q for the period ended June 30, 2026, 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 Relations: Thomas Dalton Vice President, Corporate and Government Relations, Cingulate [email protected] (480) 529-5434
Investor releaseQuarter not tagged2026-07-30Cingulate Announces Publication of Phase 3 ADHD Trial Results in Journal of Child and Adolescent Psychopharmacology
GlobeNewswire
Cingulate Announces Publication of Phase 3 ADHD Trial Results in Journal of Child and Adolescent Psychopharmacology
Publication helps establish the efficacy and safety profile of of CTx-1301, reinforcing the potential of Cingulate’s Precision Timed Release™ platform technology KANSAS CITY, Kan., July 30, 2026 (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 Phase 3 clinical trial results for its lead asset, CTx-1301 (dexmethylphenidate HCl), for the treatment of attention-deficit/hyperactivity disorder (ADHD), have been published in the Journal of Child and Adolescent Psychopharmacology and are now available through open access. The peer-reviewed publication helps establish the efficacy and safety profile of CTx-1301 and reinforces the potential of Cingulate’s Precision Timed Release™ (PTR™) platform technology, as the Company advances its lead asset toward potential regulatory approval and commercialization. The manuscript represents an important addition to the scientific literature supporting next-generation ADHD treatments designed to address ongoing challenges associated with symptom control, dosing convenience, and treatment consistency. “Publication of these Phase 3 results in a respected peer-reviewed journal represents an important milestone for Cingulate and reflects the rigorous science behind our Precision Timed Release™ (PTR™) platform,” said Cingulate Chairman and CEO Shane J. Schaffer. “The independent review and publication of our clinical data provide additional scientific support for CTx-1301 as we continue advancing this potential new treatment option for individuals living with ADHD and their families. We thank our clinical investigators, research partners, and the patients and families who participated in this study. Their contributions made this work possible.” Ann Childress, M.D., lead investigator for the Phase 3 trial, stated, “The study demonstrated clinically meaningful improvements in ADHD symptoms while maintaining a favorable safety profile, and the publication of these results provides clinicians with expert-reviewed evidence supporting CTx-1301’s potential as a once-daily treatment option.” In the Phase 3 study, all three CTx-1301 dose groups demonstrated improvements compared with placebo in the primary efficacy endpoint, me…Read full documentShow less
Publication helps establish the efficacy and safety profile of of CTx-1301, reinforcing the potential of Cingulate’s Precision Timed Release™ platform technology KANSAS CITY, Kan., July 30, 2026 (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 Phase 3 clinical trial results for its lead asset, CTx-1301 (dexmethylphenidate HCl), for the treatment of attention-deficit/hyperactivity disorder (ADHD), have been published in the Journal of Child and Adolescent Psychopharmacology and are now available through open access. The peer-reviewed publication helps establish the efficacy and safety profile of CTx-1301 and reinforces the potential of Cingulate’s Precision Timed Release™ (PTR™) platform technology, as the Company advances its lead asset toward potential regulatory approval and commercialization. The manuscript represents an important addition to the scientific literature supporting next-generation ADHD treatments designed to address ongoing challenges associated with symptom control, dosing convenience, and treatment consistency. “Publication of these Phase 3 results in a respected peer-reviewed journal represents an important milestone for Cingulate and reflects the rigorous science behind our Precision Timed Release™ (PTR™) platform,” said Cingulate Chairman and CEO Shane J. Schaffer. “The independent review and publication of our clinical data provide additional scientific support for CTx-1301 as we continue advancing this potential new treatment option for individuals living with ADHD and their families. We thank our clinical investigators, research partners, and the patients and families who participated in this study. Their contributions made this work possible.” Ann Childress, M.D., lead investigator for the Phase 3 trial, stated, “The study demonstrated clinically meaningful improvements in ADHD symptoms while maintaining a favorable safety profile, and the publication of these results provides clinicians with expert-reviewed evidence supporting CTx-1301’s potential as a once-daily treatment option.” In the Phase 3 study, all three CTx-1301 dose groups demonstrated improvements compared with placebo in the primary efficacy endpoint, measured by change from baseline in ADHD Rating Scale-5 (ADHD-RS-5) scores at Week 5. The p-values for the 18.75 mg, 25 mg, and 37.5 mg dose groups were 0.018, 0.011, and 0.001, respectively. The placebo-adjusted effect sizes were 0.737, 0.782, and 1.185, respectively, with an overall mean effect size of 0.901 across the study population. “Beyond achieving statistical significance, the magnitude of the treatment effect observed in the Phase 3 study is an important measure of the potential clinical impact of CTx-1301,” said Raul Silva, M.D., Chief Science Officer of Cingulate. “Effect size helps quantify how much improvement was observed compared with placebo, providing context on the strength of the treatment response. The effect sizes observed across all three CTx-1301 dose groups demonstrate a meaningful separation from placebo and provide additional confidence in the potential of the Precision Timed Release™ platform to deliver consistent, clinically relevant symptom improvement with once-daily dosing.” The full publication, “Efficacy and Safety of Trimodal Dexmethylphenidate (CTx-1301) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Results From a Phase 3, Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial," is available at journals.sagepub.com. About the Phase 3 Children/Adolescent Fixed Dose Study (CTx-1301-005) A double-blind, randomized, placebo-controlled, multi-center, fixed-dose (doses 18.75mg, 25mg and 37.5mg), parallel-group efficacy and safety study in a pediatric population (6-17) with ADHD The study was comprised of a screening period, a double-blind randomized phase, and a safety follow-up visit The primary endpoint of the trial was mean change in ADHD Rating Scale 5 (ADHD-RS-5) scores from baseline (pre-dose) at Visit 2 to ADHD-RS-5 scores at Visit 8 The secondary endpoint was mean change in Clinical Global Impression - Severity (CGI-S) scores within the same time frame. Multiple safety and pharmacokinetic analyses were also measured About Attention Deficit/Hyperactivity Disorder (ADHD)ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The estimated market size of the US ADHD market is approximately 100 million annual prescriptions. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. About CTx-1301CTx-1301 (dexmethylphenidate HCl) 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. About Precision Timed Release™ (PTR™) Platform TechnologyCingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here. About Cingulate Inc.Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Specifically, these statements include, but are not limited to, the efficacy and safety profile of CTx-1301, the potential of Cingulate’s Precision Timed Release™ (PTR™) platform technology, CTx-1301’s potential as a once-daily treatment option, the potential regulatory approval of CTx-1301, and the potential commercialization of CTx-1301, if approved. 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 18, 2026 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 Relations:Thomas DaltonVice President, Corporate and Government Relations, [email protected](480) 529-5434
Investor releaseQuarter not tagged2026-05-14Cingulate Inc. Reports First Quarter 2026 Financial Results and Provides an Update of Commercial Readiness Efforts On Track for lead ADHD Asset CTx-1301
GlobeNewswire
Cingulate Inc. Reports First Quarter 2026 Financial Results and Provides an Update of Commercial Readiness Efforts On Track for lead ADHD Asset CTx-1301
Cash Position Grows to $25.9 Million KANSAS CITY, Kan., May 14, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today reported financial results for the quarter ended March 31, 2026, and provided a corporate update. “Cingulate remains focused on disciplined execution in 2026 and we believe we are well positioned to bring our lead ADHD asset, CTx-1301, to market,” said Cingulate CEO Shane J. Schaffer. “We continue to engage constructively with the FDA on our new drug application while advancing commercial readiness and manufacturing capabilities, and believe our current resources provide an extended cash runway into 2027.” Strengthened Balance Sheet Cingulate enters the second quarter of 2026 with a meaningfully stronger financial position, having grown its cash and cash equivalents to $25.9 million as of March 31, 2026 — a $14.9 million increase from December 31, 2025 — driven by the successful close of a $12.0 million at-the-market private placement in February 2026 alongside opportunistic usage of the Company’s at-the-market and stock purchase agreements. Working capital increased to $17.0 million from $1.7 million at year-end, reflecting the Company's significantly improved liquidity. Management believes this capital base is sufficient to fund operations into 2027, supporting key value-creating milestones including the pursuit of regulatory approval and launch readiness for CTx-1301. Regulatory Update Cingulate is actively collaborating with the FDA to provide responses to information requests related to the manufacturing and CMC elements of its CTx-1301 NDA. The Company remains committed to working efficiently with the Agency and will provide updates as the review process progresses. Commercial Readiness Update Cingulate continues to advance its commercialization preparations, with dedicated teams established across all key functional areas. The Company’s launch strategy leverages a commercialization strategy augmented by AI-driven tools designed to optimize targeting, decision-making, and performance measurement — positioning Cingulate for a rapid commercial launch contingent upon FDA approval. Key areas of focus include: Market Access and Payer Engagement: Advancing payer strategy and re…Read full documentShow less
Cash Position Grows to $25.9 Million KANSAS CITY, Kan., May 14, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today reported financial results for the quarter ended March 31, 2026, and provided a corporate update. “Cingulate remains focused on disciplined execution in 2026 and we believe we are well positioned to bring our lead ADHD asset, CTx-1301, to market,” said Cingulate CEO Shane J. Schaffer. “We continue to engage constructively with the FDA on our new drug application while advancing commercial readiness and manufacturing capabilities, and believe our current resources provide an extended cash runway into 2027.” Strengthened Balance Sheet Cingulate enters the second quarter of 2026 with a meaningfully stronger financial position, having grown its cash and cash equivalents to $25.9 million as of March 31, 2026 — a $14.9 million increase from December 31, 2025 — driven by the successful close of a $12.0 million at-the-market private placement in February 2026 alongside opportunistic usage of the Company’s at-the-market and stock purchase agreements. Working capital increased to $17.0 million from $1.7 million at year-end, reflecting the Company's significantly improved liquidity. Management believes this capital base is sufficient to fund operations into 2027, supporting key value-creating milestones including the pursuit of regulatory approval and launch readiness for CTx-1301. Regulatory Update Cingulate is actively collaborating with the FDA to provide responses to information requests related to the manufacturing and CMC elements of its CTx-1301 NDA. The Company remains committed to working efficiently with the Agency and will provide updates as the review process progresses. Commercial Readiness Update Cingulate continues to advance its commercialization preparations, with dedicated teams established across all key functional areas. The Company’s launch strategy leverages a commercialization strategy augmented by AI-driven tools designed to optimize targeting, decision-making, and performance measurement — positioning Cingulate for a rapid commercial launch contingent upon FDA approval. Key areas of focus include: Market Access and Payer Engagement: Advancing payer strategy and reimbursement frameworks Distribution and Supply Chain: Preparing distribution infrastructure and supply chain capabilities Omnichannel Infrastructure: Deploying a comprehensive AI-augmented marketing technology to support targeting and performance optimization across channels Commercial Manufacturing: Scaling manufacturing operations and advancing process validation batch preparation for CTx-1301, which will serve as launch inventory if approved Field Force Optimization: Building out Cingulate’s sales team through an agreement with IQVIA Inc. for deployment upon potential FDA approval First Quarter Results Cash and Working Capital: As of March 31, 2026, Cingulate had approximately $25.9 million in cash and cash equivalents, a $14.9 million increase from December 31, 2025. The increase in cash was primarily driven by capital raised in the first quarter, including the close of a $12.0 million private placement. As of March 31, 2026, Cingulate had approximately $17.0 million in working capital, an increase of $15.3 million as compared to $1.7 million as of December 31, 2025. R&D Expenses: R&D expenses were $2.2 million for the three months ended March 31, 2026, a decrease of 1.8% from the three months ended March 31, 2025. The decrease is the result of lower clinical operations costs as clinical study activities concluded in early 2025, offset by an increase in regulatory and manufacturing activities in the first quarter of 2026 relating to the NDA review of CTx-1301. G&A Expenses: General and administrative expenses were $5.7 million for the three months ended March 31, 2026 compared to $1.5 million for the same period in 2025. This increase is primarily the result of costs incurred relating to the build-out of the commercial infrastructure for the launch of CTx-1301, pending FDA approval, including increased headcount. Net Loss: Net loss was $9.3 million for the three months ended March 31, 2026, compared to $3.9 million for the three months ended March 31, 2025. The increase in the net loss primarily relates to increased G&A expenses as described above as well as the change in fair value of derivative and interest on our notes payable. About Attention Deficit/Hyperactivity Disorder (ADHD) ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The estimated market size of the US ADHD market is approximately 100 million annual prescriptions. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined. 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 Precision Timed Release™ (PTR™) Platform Technology Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here. About Cingulate Inc. Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Specifically, these statements include, but are not limited to, the timing and process for regulatory approval of CTx-1301 and the potential timing of commercialization of CTx-1301, if approved, our progress with commercial readiness and manufacturing scale-up activities, statements regarding our expected cash runway, and anticipated capital needs and financing plans. 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 18, 2026 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 Relations: Thomas Dalton Vice President, Corporate and Government Relations, Cingulate [email protected] (480) 529-5434
Investor releaseQuarter not tagged2026-03-18Cingulate Inc. Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights
GlobeNewswire
Cingulate Inc. Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights
U.S. Patent Notice of Allowance for CTx-1301 Received; Additional European Patents Granted Recent $12M Private Placement Closed At-the-Market Pricing KANSAS CITY, Kan., March 18, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today reported financial results for the quarter ended December 31, 2025, and provided a corporate update. Highlights include recent U.S. and European patent developments, the closing of a $12 million private investment, and the acceptance of a New Drug Application (NDA) for its lead candidate, CTx-1301 (dexmethylphenidate HCl). Cingulate CEO Shane J. Schaffer stated, “Cingulate delivered on key inflection points throughout 2025 and this continues into 2026. Cingulate is proud to announce that CTx-1301 has strengthened its patent estate. We have demonstrated that CTx-1301 utilizing the PTR™ Platform does something meaningfully different in the treatment of ADHD, and these improvements are now recognized by patent offices in the United States as well as major territories around the world. We’ve spent years building the PTR™ platform which exclusively delivers medication how and when patients need it most, and we’re continuing to work constructively with the FDA as it evaluates our application for approval. While we advance CTx-1301 through the regulatory review process, our Company has strengthened its financial and operational foundation,” Schaffer continued. “At the same time, we are advancing our commercial readiness and manufacturing scale-up, so we’re well positioned to support commercial launch, pending approval. With the support of our recent financing and the addition of experienced commercial leadership, we believe we’re taking the right steps to build long-term value for both patients and shareholders.” Operational Highlights U.S. Patent Notice of Allowance On Tuesday, March 17th, 2026, the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for a patent application covering Cingulate’s lead ADHD candidate, CTx-1301, indicating that the agency has completed its examination and determined that the claims are allowable. Upon issuance, the patent is expected to provide protection through May 2042 for key aspects of CTx-1301’s formulation…Read full documentShow less
U.S. Patent Notice of Allowance for CTx-1301 Received; Additional European Patents Granted Recent $12M Private Placement Closed At-the-Market Pricing KANSAS CITY, Kan., March 18, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today reported financial results for the quarter ended December 31, 2025, and provided a corporate update. Highlights include recent U.S. and European patent developments, the closing of a $12 million private investment, and the acceptance of a New Drug Application (NDA) for its lead candidate, CTx-1301 (dexmethylphenidate HCl). Cingulate CEO Shane J. Schaffer stated, “Cingulate delivered on key inflection points throughout 2025 and this continues into 2026. Cingulate is proud to announce that CTx-1301 has strengthened its patent estate. We have demonstrated that CTx-1301 utilizing the PTR™ Platform does something meaningfully different in the treatment of ADHD, and these improvements are now recognized by patent offices in the United States as well as major territories around the world. We’ve spent years building the PTR™ platform which exclusively delivers medication how and when patients need it most, and we’re continuing to work constructively with the FDA as it evaluates our application for approval. While we advance CTx-1301 through the regulatory review process, our Company has strengthened its financial and operational foundation,” Schaffer continued. “At the same time, we are advancing our commercial readiness and manufacturing scale-up, so we’re well positioned to support commercial launch, pending approval. With the support of our recent financing and the addition of experienced commercial leadership, we believe we’re taking the right steps to build long-term value for both patients and shareholders.” Operational Highlights U.S. Patent Notice of Allowance On Tuesday, March 17th, 2026, the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for a patent application covering Cingulate’s lead ADHD candidate, CTx-1301, indicating that the agency has completed its examination and determined that the claims are allowable. Upon issuance, the patent is expected to provide protection through May 2042 for key aspects of CTx-1301’s formulation and method of use, further strengthening Cingulate’s intellectual property portfolio surrounding its Precision Timed Release™ (PTR™) platform, which is designed to enable the development of next-generation therapeutics with customized release profiles. European Patent Granted Cingulate received a European patent for CTx-1301 covering the specificity of its tri-modal, precision-timed pulsatile release profile for the treatment of ADHD. The patent (EP No. 22808184), granted on December 17, 2025, extends protection through May 2042 and is expected to be validated in more than 30 European territories, including the United Kingdom. Regulatory In July 2025, Cingulate submitted the New Drug Application (NDA) for CTx-1301, the Company’s lead asset for the treatment of ADHD in children and adults. In October 2025, the FDA accepted the NDA for review under the 505(b)(2) regulatory pathway and assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. The NDA was supported by multiple clinical studies, including Phase 3 clinical trials showing improved ADHD control across multiple metrics in adult and pediatric patients (ages 6 years and older). Effect size measurements, the consistency and magnitude of benefit of the product, were large throughout the day, demonstrating that CTx-1301 provides a rapid onset of effect and sustained efficacy for a patient’s entire active day, addressing long-standing gaps in ADHD management. As part of the NDA review process, the FDA has requested additional information related to manufacturing and CMC elements of the application. The Company is working closely with the Agency to address these requests. Depending on the timing and scope of these requests and responses, the FDA may require additional time to evaluate the information provided. Importantly, to date the requests do not relate to clinical safety or efficacy findings. Commercial Readiness Update The Company continues to advance commercialization preparations, including: Scaling commercial manufacturing Advancing market access and payer engagement Building commercial leadership and infrastructure Preparing distribution and supply chain capabilities In November, Cingulate appointed Bryan Downey as Chief Commercial Officer. Downey brings extensive commercialization experience, having held senior leadership roles at Alfasigma USA, Jubilant Pharma, and nearly 20 years at Sanofi, where he served as Vice President and Head of the U.S. Cardiovascular and Allergy Business Unit. Capital Markets Activity $12 Million At-the-Market PIPE Financing In February 2026, Cingulate closed a $12 million private investment in public equity (PIPE) financing led by affiliates of Falcon Creek Capital Advisor LLC. The financing was priced at-the-market under Nasdaq rules and included insider participation. All participating investors agreed to a 180-day lock-up, aligning long-term shareholder interests ahead of key regulatory milestones. In connection with the financing, Falcon Creek Capital received the right to designate up to two members to Cingulate’s Board of Directors. The first designee is former board member Jeff Hargroves, who was also a significant participant in the offering. Fourth Quarter and Full Year Results Cash and Working Capital: As of December 31, 2025, Cingulate had approximately $11.0 million in cash and cash equivalents, a $1.3 million decrease from December 31, 2024. The Company expects current cash on hand will satisfy its capital needs into late fourth quarter of 2026 under the current business plan, which primarily includes activities related to seeking regulatory approval for CTx-1301 and pre-commercialization efforts for CTx-1301. R&D Expenses: Research and development expenses were $2.0 million for the three months ended December 31, 2025, compared to $4.3 million for the same period in 2024. Research and development expenses were $9.8 million for the year ended December 31, 2025, compared to $9.4 million for the year ended December 31, 2024. This change was primarily the result of an increase in personnel expenses, regulatory costs and manufacturing costs, partially offset by a decrease in clinical operations. G&A Expenses: General and administrative expenses were $3.6 million for the three months ended December 31, 2025, compared to $1.9 million for the same period in 2024. General and administrative expenses were $10.2 million for the year ended December 31, 2025, compared to $6.2 million for the year ended December 31, 2024. This is primarily the result of an increase in pre-commercialization costs, personnel expenses and legal and professional fees. Net Loss: Net loss was $6.3 million for the three months ended December 31, 2025, compared to $6.2 million for the three months ended December 31, 2024. Net loss was $22.4 million for the year ended December 31, 2025, compared to $16.6 million for the year ended December 31, 2024. The increase in the net loss primarily relates to increased G&A expenses as described above as well as interest on our notes payable. About Attention Deficit/Hyperactivity Disorder (ADHD) ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The estimated market size of the US ADHD market is approximately 100 million annual prescriptions. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined. 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 Precision Timed Release™ (PTR™) Platform Technology Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here. About Cingulate Inc. Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Specifically, these statements include, but are not limited to, the timing and process for regulatory approval of CTx-1301 and the potential timing of commercialization of CTx-1301, if approved, our progress with commercial readiness and manufacturing scale-up activities, statements regarding our expected cash runway, and anticipated capital needs and financing plans. 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 18, 2026 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 Relations: Thomas Dalton Vice President, Corporate and Government Relations, Cingulate [email protected] (480) 529-5434
Investor releaseQuarter not tagged2025-11-18CING: Third Quarter Results
Zacks Small Cap Research
CING: Third Quarter Results
By John Vandermosten, CFA NASDAQ:CING READ THE FULL CING RESEARCH REPORT Cingulate, Inc. (NASDAQ:CING) reported third quarter 2025 results on November 13th, 2025. No revenues were recorded and operating expense totaled $6.0 million. The new drug application (NDA) to the FDA was accepted and a PDUFA date of May 31st, 2026 was given. Cingulate also saw changes in its management ranks as the company’s focus shifts to pre-commercialization activities which included the appointment of Bryan Downey as Chief Commercial Officer. Company representatives have participated in investor and medical conferences, highlighted by Dr. Ann Childress’ podium presentation at AACAP and attendance at the Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD) conference. In the financing sphere, a purchase agreement was signed with Lincoln Park Capital, which is expected to augment the in place at-the-market (ATM) facility and support the crescendo of activities leading up to the anticipated approval next year. 3Q:25 Financial and Operational Results Cingulate reported third quarter results in a press release and Form 10-Q filing with the SEC on November 13th. For the quarter ending September 30th, 2025, the company reported a net loss of ($7.3) million or ($1.359) per share. For 3Q:25 versus the same prior year period: Research and development expenses were $2.8 million, nearly doubling from $1.4 million. The change was attributable to an increase in personnel expenses, manufacturing costs and regulatory costs. Personnel costs were further broken down into separation costs for an executive recognized in August 2025 and the payment of a contingent bonus plan that were payable upon acceptance of the NDA by the FDA. Manufacturing costs were related to preparation for product validation batches of CTx-1301. Regulatory costs were up as the team prepared to submit the NDA; General & administrative expenses rose 70% to $3.1 million from $1.9 million on account of increased personnel and other expenses, higher costs related to the arrangement with Indegene and personnel expenses related to the contingent bonus plan earned upon FDA acceptance of the NDA; Net interest and other expense were ($1.3) million compared to ($844,000) related to derivative change in fair value issued to Lincoln Park and its share purchase commitment and interest expense incurred on the promissor…Read full documentShow less
By John Vandermosten, CFA NASDAQ:CING READ THE FULL CING RESEARCH REPORT Cingulate, Inc. (NASDAQ:CING) reported third quarter 2025 results on November 13th, 2025. No revenues were recorded and operating expense totaled $6.0 million. The new drug application (NDA) to the FDA was accepted and a PDUFA date of May 31st, 2026 was given. Cingulate also saw changes in its management ranks as the company’s focus shifts to pre-commercialization activities which included the appointment of Bryan Downey as Chief Commercial Officer. Company representatives have participated in investor and medical conferences, highlighted by Dr. Ann Childress’ podium presentation at AACAP and attendance at the Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD) conference. In the financing sphere, a purchase agreement was signed with Lincoln Park Capital, which is expected to augment the in place at-the-market (ATM) facility and support the crescendo of activities leading up to the anticipated approval next year. 3Q:25 Financial and Operational Results Cingulate reported third quarter results in a press release and Form 10-Q filing with the SEC on November 13th. For the quarter ending September 30th, 2025, the company reported a net loss of ($7.3) million or ($1.359) per share. For 3Q:25 versus the same prior year period: Research and development expenses were $2.8 million, nearly doubling from $1.4 million. The change was attributable to an increase in personnel expenses, manufacturing costs and regulatory costs. Personnel costs were further broken down into separation costs for an executive recognized in August 2025 and the payment of a contingent bonus plan that were payable upon acceptance of the NDA by the FDA. Manufacturing costs were related to preparation for product validation batches of CTx-1301. Regulatory costs were up as the team prepared to submit the NDA; General & administrative expenses rose 70% to $3.1 million from $1.9 million on account of increased personnel and other expenses, higher costs related to the arrangement with Indegene and personnel expenses related to the contingent bonus plan earned upon FDA acceptance of the NDA; Net interest and other expense were ($1.3) million compared to ($844,000) related to derivative change in fair value issued to Lincoln Park and its share purchase commitment and interest expense incurred on the promissory note; Net loss was ($7.3) million vs. ($4.1) million or ($1.35) and ($3.60) per share respectively. As of September 30th, 2025, cash totaled $6.1 million. This amount compares to the $12.2 million cash balance held at the end of 2024. Cash burn was ($13.7) million for the first nine months of 2025, partially offset by $7.6 million in financing cash contributions from the ATM Agreement with H.C. Wainwright and the Lincoln Park Purchase Agreement. After quarter end, Cingulate issued additional shares through the ATM and Purchase Agreement to raise additional capital. It also exchanged shares to repay $850,000 in principal of the existing promissory note. A new promissory note with a face value of $6.57 million was issued in November to support near-term financing needs as Cingulate looks at multiple sources of capital as it prepares for commercialization. Management estimates that the company will need approximately $7 million in additional capital to support operations until the anticipated approval of CTx-1301. Dr. Ann Childress AACAP Podium Presentation Data from the CTx-1301 trials were presented at the American Academy of Child and Adolescent Psychiatry (AACAP) Annual Meeting in Chicago on October 24th, 2025. Dr. Ann Childress, President of the Center for Psychiatry and Behavioral Medicine and principal investigator on the CTx-1301 trials, gave the presentation. The data was generated in a randomized, double-blind, pediatric and adolescent, placebo-controlled study. The data showed that CTx-1301 produced a rapid onset of effect and sustained efficacy through the evening hours. Safety and tolerability were consistent with the stimulant class, with no unexpected adverse events reported. Dr. Childress, quoted in the press release, said: “In summary, CTx1301 demonstrated dose dependent efficacy in improving ADHD symptoms in children and adolescents. The 37.5mg dose demonstrated the largest effect size in symptom reduction and effect sizes were pretty substantial, considering this was a forced dose and not a dose optimization study. The safety profile did not show anything that would be of concern, as it looks like other methylphenidates.” In our view, the selection of CTx-1301 for a podium presentation reflects increasing recognition of the product’s potential to address unmet needs in ADHD. The timed delivery of three doses throughout the day recognizes the half-life limitations of dexmethylphenidate and the needs of ADHD patients which extend from morning to evening, but not beyond. We further see this recognition as an indication of broad interest among providers that prescribe the drug. To watch other videos in this series with Dr. Childress, click the links below. Podium Presentation at AACAP Importance of Drug Half Life The Fastest Growing ADHD Population Difficult Times to Treat ADHD CTx-1301 Accepted By The FDA Forced Dose Titration Study CTx-1301 Adult Data CTx-1301 History Non-Stimulant ADHD Medications ADHD During COVID Animals, AI & AACAP CTx-1301 FDA Submission Timeline On August 6th, Cingulate announced that it had submitted its NDA to the FDA for CTx-1301. On October 14th, it announced that the NDA had been accepted and a PDUFA date of May 31st, 2026 was assigned. Assuming that CTx-1301 is approved, commercialization could start as soon as next year. Cingulate will work with Indegene[1] to commercialize the product in the United States and may also pursue a co-promote that would leverage the strengths of multiple parties. Outside the US, Cingulate is looking for partners to commercialize CTx-1301. Beyond international sales, the goal of these relationships is to obtain upfront amounts that will support CTx-1301’s launch in the United States. While the team has not affirmed any specific discussions, we believe that they have had at least initial talks with prospective global partners. Management Changes On August 15th, Cingulate provided a management update informing investors of the appointment of CFO Jennifer Callahan as interim CEO and board member Jay Roberts as Executive Chairman. Shane Schaffer was placed on administrative leave in connection with ongoing legal matters unrelated to the company and its operations. While any change in management calls for a review of the team, the heavy lifting for the next year has been accomplished with the successful submission of the NDA for CTx-1301. We expect the team to begin a measured ramp of pre-commercialization activities. In November, Cingulate announced that it had named Bryan Downey as Chief Commercial Officer. Mr. Downey has more than 25 years of experience in commercial strategy, leadership, and business transformation, including pharmaceutical product launches. Most recently, he has served as Managing Director at CRA’s advisory practice. Previously, he held senior executive roles at Alfasigma USA and Jubilant Pharma, leading commercial operations and product commercialization efforts. Bryan also spent nearly two decades at Sanofi, where he served as Vice President and Head of the U.S. Cardiovascular and Allergy Business Unit where he oversaw multiple product launches and brand strategies across diverse therapeutic areas. Bryan began his role with long “To Do” list. He is working on pricing reimbursement and market access, scientific publications and awareness and building out the omnichannel. He will also be working with key account managers to evaluate options for contracting. Objectives Over the Next Twelve Months With the submission of CTx-1301 now complete, and acceptance granted in October, we now look ahead to the PDUFA date in May 2026. In parallel with the regulatory process, Cingulate management and related parties will participate in investor and medical conferences to communicate the value of its product. CEO Jennifer Callahan, Vice President of Corporate Communications Thomas Dalton and co-founders Dr. Matthew Brams and Dr. Raul Silva are all participating in the messaging effort on behalf of the company. A key opinion leader in the attention-deficit/hyperactivity disorder (ADHD) space and advisor for Cingulate, Dr. Ann Childress, will also present at medical conferences over the next several months. This includes the American Academy of Child and Adolescent Psychiatry (AACAP) conference in October where she will be presenting on behalf of the company. Pre-commercialization activities have also moved to the forefront. Cingulate has announced its non-binding arrangement with Indegene to commercialize CTx-1301 in the United States on a fee for service basis. In preparation, management is now conducting market access research to better understand how its time release version of dexmethylphenidate can be successfully adopted, reimbursed, and used by patients. The company will also soon sign its commercial supply agreement and begin the manufacturing of process validation batches. The resulting drug product will be saleable and can be used to fulfill pre-launch inventory. Milestones High dose food effect study, CTx-1301 completed – January 2025 DCAT Association Meeting in New York – March 2025 Final data from CTx-1301 fast-fed study – April 2025 FDA pre-NDA meeting – April 2nd, 2025 Written notes from pre-NDA meeting – May 2025 CTx-1301 NDA submitted to FDA – July 31st, 2025 Jennifer Callahan appointed as interim CEO - August 2025 Jay Roberts appointed as executive chairman – August 2025 Bryan Downey appointed as Chief Commercial Officer – November 2025 Participation in the CHADD conference in Kansas City – November 2025 Completion of $6 million financing – November 2025 CTx-1301 PDUFA Date – May 31st, 2026 Partnership development – 2025/2026 SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE. ________________________ [1] See our initiation for further details on the Indegene Joint Commercialization Agreement.
Investor releaseQuarter not tagged2025-11-13Cingulate Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Cingulate Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Industry Veteran Bryan Downey Named Chief Commercial Officer NDA Accepted with May 2026 PDUFA Date Commercial Supply Agreement Executed KANSAS CITY, Kan., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to build a pipeline of next-generation products, today announced financial results for the quarter ended September 30, 2025, and provided recent corporate highlights. Recent Highlights (Post-Q3) FDA Accepts NDA for CTx-1301; PDUFA Date Set for May 31, 2026 In October of 2025, the U.S. Food and Drug Administration (FDA) accepted Cingulate’s New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl), a once-daily, extended-release therapy designed to optimize ADHD treatment. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026, confirming the NDA is complete and ready for review. Industry Veteran Bryan Downey Named Chief Commercial Officer; $6 Million Financing Completed On November 3, 2025, Cingulate appointed Bryan Downey as Chief Commercial Officer, and announced the completion of a $6 million financing transaction, further strengthening its balance sheet as the company prepares for potential commercialization. Downey brings over 25 years of experience in commercial strategy, leadership, and successful pharmaceutical launches, having held senior executive roles at Alfasigma USA, Jubilant Pharma, and Sanofi. In conjunction with Downey’s 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, subject to the terms of the note and other conditions. Cingulate intends to use the proceeds for working capital and other general corporate purposes. The summary of the financing terms herein is qualified in its entirety by the definitive agreements filed with the SEC. Positive Phase 3 Results Presented at Annual AACAP Conference The positive Phase 3 results from Cingulate’s pivotal trial of CTx-1301 were recently presented by Ann Chil…Read full documentShow less
Industry Veteran Bryan Downey Named Chief Commercial Officer NDA Accepted with May 2026 PDUFA Date Commercial Supply Agreement Executed KANSAS CITY, Kan., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to build a pipeline of next-generation products, today announced financial results for the quarter ended September 30, 2025, and provided recent corporate highlights. Recent Highlights (Post-Q3) FDA Accepts NDA for CTx-1301; PDUFA Date Set for May 31, 2026 In October of 2025, the U.S. Food and Drug Administration (FDA) accepted Cingulate’s New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl), a once-daily, extended-release therapy designed to optimize ADHD treatment. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026, confirming the NDA is complete and ready for review. Industry Veteran Bryan Downey Named Chief Commercial Officer; $6 Million Financing Completed On November 3, 2025, Cingulate appointed Bryan Downey as Chief Commercial Officer, and announced the completion of a $6 million financing transaction, further strengthening its balance sheet as the company prepares for potential commercialization. Downey brings over 25 years of experience in commercial strategy, leadership, and successful pharmaceutical launches, having held senior executive roles at Alfasigma USA, Jubilant Pharma, and Sanofi. In conjunction with Downey’s 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, subject to the terms of the note and other conditions. Cingulate intends to use the proceeds for working capital and other general corporate purposes. The summary of the financing terms herein is qualified in its entirety by the definitive agreements filed with the SEC. Positive Phase 3 Results Presented at Annual AACAP Conference The positive Phase 3 results from Cingulate’s pivotal trial of CTx-1301 were recently presented by Ann Childress, M.D., at the AACAP Annual Meeting in Chicago. CTx-1301 met its primary endpoint, demonstrating dose-dependent improvements on the ADHD ratings scale 5 (ADHD-RS-5), and Clinical Global Impression-Severity (CGI-S) scales, and demonstrated the ability to deliver symptom relief with the convenience of once-daily dosing. “Cingulate has made meaningful progress this quarter toward key value-creating milestones,” said Jay Roberts, Executive Chairman of Cingulate. “The FDA’s acceptance of our NDA for CTx-1301, the appointment of an experienced commercial leader in Bryan Downey, and the completion of a $6 million financing collectively strengthen our position as we advance toward a potential 2026 launch. We remain focused on disciplined execution, operational efficiency, and creating long-term value for our shareholders.” Third Quarter Activities: Commercial Supply Agreement Reached with Bend Bio Sciences Cingulate announced in September that it has entered into a commercial supply agreement with Bend Bio Sciences for the manufacturing of CTx-1301. Under the new agreement, Bend Bio Sciences will serve as the exclusive commercial manufacturer of CTx-1301 in the United States through 2028, if approved by the FDA, and Cingulate has committed to purchasing 100% of its overall U.S. commercial supply of CTx-1301 from Bend, following and subject to any FDA approval. $4.3 Million PDUFA Fee Waiver Granted by FDA In July Cingulate received a fiscal year 2025 PDUFA (Prescription Drug User Fee Act) fee waiver from the FDA for its NDA for CTx-1301. Granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the waiver will save the Company approximately $4.3 million. THIRD QUARTER RESULTS Cash and Working Capital: As of September 30, 2025, Cingulate had approximately $6.1 million in cash and cash equivalents, a $6.1 million decrease from December 31, 2024. The Company expects its cash will satisfy its capital needs into the second quarter of 2026 under the current business plan. To advance the commercialization efforts through the May 31, 2026 PDUFA date for CTx-1301, the Company will need to raise approximately $7.0 million of additional capital. As of September 30, 2025, Cingulate had approximately $1.6 million in working capital, a decrease of $6.1 million as compared to $7.7 million as of December 31, 2024. R&D Expenses: Research and development expenses were $2.8 million for the three months ended September 30, 2025, an increase of $1.4 million or 99.5% from the three months ended September 30, 2024. This change was the result of an increase in personnel expenses, manufacturing costs and regulatory costs. Personnel expenses increased due to separation costs for an executive in August 2025 as well as costs related to the contingent bonus plan, which were accrued upon the NDA submission of CTx-1301 in the third quarter of 2025. The increase in manufacturing costs was due to more significant manufacturing costs in 2025 related to activity in preparation of the manufacturing of the process validation batches of CTx-1301. Regulatory costs increased due to preparation for the NDA submission. G&A Expenses: G&A expenses were $3.1 million for the three months ended September 30, 2025, an increase of $1.3 million or 69.7% from the three months ended September 30, 2024. This is primarily the result of an increase personnel and other expenses. The increase in personnel expenses was due to costs related to the contingent bonus plan, which were accrued upon the NDA submission of CTx-1301 in the third quarter of 2025. Other costs increased primarily due to commercial costs incurred in preparation of a potential mid-2026 launch of CTx-1301. Net Loss: Net loss was $7.3 million for the three months ended September 30, 2025, compared to $4.1 million for the three months ended September 30, 2024. The increase in the net loss primarily relates to increased research and development costs and G&A expenses as described above. About Attention Deficit/Hyperactivity Disorder (ADHD) ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined. 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 Precision Timed Release™ (PTR™) Platform Technology Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here. About Cingulate Inc. Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Specifically, these statements include, but are not limited to, statements regarding our expected cash runway, anticipated capital needs and financing plans, regulatory timelines for CTx-1301, the potential timing of commercialization of CTx-1301 and manufacturing and supply arrangements. 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 Relations: Thomas Dalton Vice President, Corporate Communications, Cingulate [email protected] (913) 942-2301
Investor releaseQuarter not tagged2025-10-28Cingulate Presents Positive Phase 3 Results for CTx-1301 Demonstrating Statistically Significant Efficacy and Entire Active-Day Symptom Control
GlobeNewswire
Cingulate Presents Positive Phase 3 Results for CTx-1301 Demonstrating Statistically Significant Efficacy and Entire Active-Day Symptom Control
Once-daily formulation of dexmethylphenidate achieved primary endpoint (p < 0.001) with consistent symptom relief up to 12 hours post-dose KANSAS CITY, Kan., Oct. 28, 2025 (GLOBE NEWSWIRE) -- 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, announced today that the positive Phase 3 results from its pivotal trial of CTx-1301 (dexmethylphenidate HCl) in pediatric ADHD, were recently presented by Ann Childress, M.D., at the AACAP Annual Meeting in Chicago. CTx-1301 met its primary endpoint, demonstrating dose-dependent improvements on the ADHD ratings scale 5 (ADHD-RS-5), and Clinical Global Impression-Severity (CGI-S) scales, and demonstrated the ability to deliver symptom relief with the convenience of once-daily dosing. In the randomized, double-blind, pediatric and adolescent, placebo-controlled study, CTx-1301 delivered rapid onset of effect and sustained efficacy through the evening hours. Safety and tolerability were consistent with the stimulant class, with no unexpected adverse events reported. “In summary, CTx1301 demonstrated dose dependent efficacy in improving ADHD symptoms in children and adolescents. The 37.5mg dose demonstrated the largest effect size in symptom reduction and effect sizes were pretty substantial, considering this was a forced dose and not a dose optimization study,” Dr. Childress stated during the presentation. “The safety profile did not show anything that would be of concern, as it looks like other methylphenidates.” ADHD represents a $23 billion global market, yet most treatments require two or more daily doses. CTx-1301 offers the potential for simpler once-daily management, which could translate to better adherence for patients and families. Cingulate’s commercial partnership with Indegene, a digital-first, life sciences commercialization company, is designed around a variable-cost structure that aligns commercial execution with growth milestones as the company approaches launch. The New Drug Application for CTx-1301 was accepted by the FDA in October 2025, with a target PDUFA date of May 31, 2026. Cingulate also received a waiver of the standard PDUFA filing fee. Granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic A…Read full documentShow less
Once-daily formulation of dexmethylphenidate achieved primary endpoint (p < 0.001) with consistent symptom relief up to 12 hours post-dose KANSAS CITY, Kan., Oct. 28, 2025 (GLOBE NEWSWIRE) -- 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, announced today that the positive Phase 3 results from its pivotal trial of CTx-1301 (dexmethylphenidate HCl) in pediatric ADHD, were recently presented by Ann Childress, M.D., at the AACAP Annual Meeting in Chicago. CTx-1301 met its primary endpoint, demonstrating dose-dependent improvements on the ADHD ratings scale 5 (ADHD-RS-5), and Clinical Global Impression-Severity (CGI-S) scales, and demonstrated the ability to deliver symptom relief with the convenience of once-daily dosing. In the randomized, double-blind, pediatric and adolescent, placebo-controlled study, CTx-1301 delivered rapid onset of effect and sustained efficacy through the evening hours. Safety and tolerability were consistent with the stimulant class, with no unexpected adverse events reported. “In summary, CTx1301 demonstrated dose dependent efficacy in improving ADHD symptoms in children and adolescents. The 37.5mg dose demonstrated the largest effect size in symptom reduction and effect sizes were pretty substantial, considering this was a forced dose and not a dose optimization study,” Dr. Childress stated during the presentation. “The safety profile did not show anything that would be of concern, as it looks like other methylphenidates.” ADHD represents a $23 billion global market, yet most treatments require two or more daily doses. CTx-1301 offers the potential for simpler once-daily management, which could translate to better adherence for patients and families. Cingulate’s commercial partnership with Indegene, a digital-first, life sciences commercialization company, is designed around a variable-cost structure that aligns commercial execution with growth milestones as the company approaches launch. The New Drug Application for CTx-1301 was accepted by the FDA in October 2025, with a target PDUFA date of May 31, 2026. Cingulate also received a waiver of the standard PDUFA filing fee. Granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the waiver will save Cingulate approximately $4.3 million. “These results demonstrate that CTx-1301 can deliver reliable symptom control for the entire active-day in a single dose — something families and clinicians have wanted for years. With this Phase 3 data in hand, we believe CTx-1301 is well positioned to become a next-generation treatment for ADHD as we move toward potential approval and launch in 2026,” said Raul Silva, M.D., Chief Science Officer of Cingulate. The Company plans to share additional details from the Phase 3 study in upcoming scientific publications and investor communications. Dr. Childress recently appeared on the “Unboxing Biotech” webcast with John Vandermosten, Senior Analyst for Zacks Investment Research, where she discussed the podium presentation and CTx-1301 data during a wide-ranging discussion about ADHD. The segment can be viewed here. 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 HCl) 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. 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. About Ann Childress, M.D. Ann C. Childress, M.D., a board-certified physician in Psychiatry and Child and Adolescent Psychiatry, has been a practicing psychiatrist for more than 35 years. Dr. Childress has held numerous prominent positions, including chief of mental health at various psychiatric hospitals as well as professorships within prestigious universities. Dr. Childress is past President of the American Professional Society of ADHD and Related Disorders, Education Director for the Nevada Psychiatric Association, a Distinguished Life Fellow of the American Psychiatric Association and a member of the American Academy of Child and Adolescent Psychiatry. Dr. Childress is the founder and principal investigator of Clinical Research of Southern Nevada and is the founder and president of the Center for Psychiatry and Behavioral Medicine, both entities located in Las Vegas, Nevada. She has conducted more than 200 clinical studies, working on most of the major psychiatric drugs that have been approved for ADHD over the last few decades by various major pharmaceutical companies, including Pfizer, Janssen, Shire, and Novartis. Dr. Childress has been working with Cingulate since 2018, serving as a key opinion and thought leader, helping design multiple clinical protocols, and currently serving as the lead investigator on Cingulate’s Phase 3 Fixed-Dose Study in pediatrics and adolescents. 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 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: [email protected] | Phone: (913) 942-2301
Investor releaseQuarter not tagged2025-08-19Cingulate Inc. Reports Second Quarter 2025 Financial Results and Provides Recent Highlights
GlobeNewswire
Cingulate Inc. Reports Second Quarter 2025 Financial Results and Provides Recent Highlights
Submitted New Drug Application (NDA) to the FDA for lead asset CTx-1301 Anticipate FDA Decision in Q4 2025 regarding NDA Acceptance with Potential PDUFA Date in Mid-2026 KANSAS CITY, Kan., Aug. 19, 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 its financial results for the quarter ended June 30, 2025, and provided recent highlights. Recent Highlights: On July 31, 2025, Cingulate submitted its NDA to the FDA for CTx-1301, a novel, extended-release tablet formulation of dexmethylphenidate designed to deliver a fast onset, entire active-day efficacy, and a smooth pharmacokinetic profile with a single dose, addressing major limitations of current ADHD therapies. The FDA guides that a decision is often made regarding acceptance of the NDA within 60 days. Submission of the NDA came after the following second quarter activities: Pre-NDA meeting with the FDA; Announcement of positive top-line results from the high dose (50mg) fed/fast study of CTx-1301, demonstrating that CTx-1301 can be taken with or without food; and Announcement of results of Phase 3 pediatric study of CTx-1301, demonstrating marked improvement of ADHD symptoms at week five, illustrating the potential benefits of the product and the value of the Precision Timed Release Platform. In addition, on July 21, 2025, Cingulate entered into a purchase agreement with Lincoln Park Capital, pursuant to which Lincoln Park agreed to purchase from the Company from time to time, over the 36-month term of the agreement and at the Company’s sole discretion, up to an aggregate of $25.0 million of common stock (subject to certain limitations and satisfaction of the conditions set forth in the purchase agreement). Jay Roberts, Executive Chairman of Cingulate’s Board of Directors, stated, “Submission of the NDA to the FDA for lead asset CTx-1301 marked a pivotal moment in Cingulate’s progression, reflecting years of dedication to developing a truly differentiated ADHD treatment through the Precision Timed Release platform. In addition, the recently executed agreement with Lincoln Park Capital allows management to be opportunistic in its capital needs as we prioritize pre-commercial activities in anti…Read full documentShow less
Submitted New Drug Application (NDA) to the FDA for lead asset CTx-1301 Anticipate FDA Decision in Q4 2025 regarding NDA Acceptance with Potential PDUFA Date in Mid-2026 KANSAS CITY, Kan., Aug. 19, 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 its financial results for the quarter ended June 30, 2025, and provided recent highlights. Recent Highlights: On July 31, 2025, Cingulate submitted its NDA to the FDA for CTx-1301, a novel, extended-release tablet formulation of dexmethylphenidate designed to deliver a fast onset, entire active-day efficacy, and a smooth pharmacokinetic profile with a single dose, addressing major limitations of current ADHD therapies. The FDA guides that a decision is often made regarding acceptance of the NDA within 60 days. Submission of the NDA came after the following second quarter activities: Pre-NDA meeting with the FDA; Announcement of positive top-line results from the high dose (50mg) fed/fast study of CTx-1301, demonstrating that CTx-1301 can be taken with or without food; and Announcement of results of Phase 3 pediatric study of CTx-1301, demonstrating marked improvement of ADHD symptoms at week five, illustrating the potential benefits of the product and the value of the Precision Timed Release Platform. In addition, on July 21, 2025, Cingulate entered into a purchase agreement with Lincoln Park Capital, pursuant to which Lincoln Park agreed to purchase from the Company from time to time, over the 36-month term of the agreement and at the Company’s sole discretion, up to an aggregate of $25.0 million of common stock (subject to certain limitations and satisfaction of the conditions set forth in the purchase agreement). Jay Roberts, Executive Chairman of Cingulate’s Board of Directors, stated, “Submission of the NDA to the FDA for lead asset CTx-1301 marked a pivotal moment in Cingulate’s progression, reflecting years of dedication to developing a truly differentiated ADHD treatment through the Precision Timed Release platform. In addition, the recently executed agreement with Lincoln Park Capital allows management to be opportunistic in its capital needs as we prioritize pre-commercial activities in anticipation of the launch of lead asset CTx-1301 in mid-2026, pending FDA approval.” SECOND QUARTER RESULTS Cash and Working Capital: As of June 30, 2025, Cingulate had approximately $8.9 million in cash and cash equivalents, a $3.3 million decrease from December 31, 2024. The Company expects its cash will satisfy its capital needs into late 2025 under the current business plan. To advance the commercialization efforts for CTx-1301 into early 2026, the Company will need to raise approximately $1.5 million of additional capital. As of June 30, 2025, Cingulate had approximately $3.5 million in working capital, a decrease of $4.2 million as compared to $7.7 million as of December 31, 2024. R&D Expenses: Research and development expenses were $2.7 million for the three months ended June 30, 2025, an increase of $0.8 million or 43.6% from the three months ended June 30, 2024. This change was the result of an increase in both clinical and regulatory costs due to activities which occurred in the preparation of the NDA submission of CTx-1301, including data analysis costs and regulatory consulting costs, partially offset by a decrease in manufacturing costs. G&A Expenses: G&A expenses were $1.9 million for the three months ended June 30, 2025, an increase of $0.6 million or 47.1% from the three months ended June 30, 2024. This is primarily the result of an increase in legal and financial advisory fees. Net Loss: Net loss was $4.8 million for the three months ended June 30, 2025, compared to $3.2 million for the three months ended June 30, 2024. The increase in the net loss primarily relates to increased research and development costs as described above. About Attention Deficit/Hyperactivity Disorder (ADHD) ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined. About CTx-1301 Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off. About Precision Timed Release™ (PTR™) Platform Technology Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here. About Cingulate Inc. Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on 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 Relations: Thomas Dalton Vice President, Corporate Communications, Cingulate [email protected] (913) 942-2301
Investor releaseQuarter not tagged2025-05-20Efficacy Results Announced from Cingulate’s Phase 3 Pediatric Study of CTx-1301 (dexmethylphenidate) for ADHD
GlobeNewswire
Efficacy Results Announced from Cingulate’s Phase 3 Pediatric Study of CTx-1301 (dexmethylphenidate) for ADHD
Subjects Demonstrated Marked Improvement of ADHD Symptoms at Week 5New Drug Application on Schedule for this Summer CING CEO Shares Insights and Strategic Outlook on “Unboxing Biotech” Podcast KANSAS CITY, Kan., May 20, 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 the efficacy results from an FDA required Phase 3, randomized, fixed dose, double blind, placebo controlled clinical study in pediatrics (aged 6-17), for its lead asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The primary efficacy endpoint of the study was change in total score on the ADHD-RS-5 rating scale (a scale which measures aspects of ADHD in pediatrics). The fixed doses used in the study were 18.75-mg; 25-mg and 37.5-mg. Pending approval by the FDA, Cingulate expects to launch CTx-1301 with a total of eight dosage strengths, six of which are expected to treat patients under the age of 18. "In a randomized, double-blind, placebo-controlled Phase 3 trial in pediatric ADHD patients, CTx-1301 demonstrated statistically significant improvements in ADHD symptoms across all fixed doses, achieving robust effect sizes (0.737 to 1.185) within 5 weeks,” said Cingulate Chief Science Officer Raul R. Silva, MD. “These results illustrate that CTx-1301, if approved by the FDA, is positioned to become a potential first-line treatment for providers to overcome the longstanding unmet needs facing the millions of ADHD patients worldwide.” Cingulate Chairman and CEO Shane J. Schaffer stated, “These compelling results once again validate the therapeutic benefits and commercial potential of CTx-1301. Achieving statistically significant outcomes and remarkable effect sizes across all tested dose levels illustrates the potential benefits of our product and the value of our Precision Timed Release ™ Platform. These findings represent a significant value inflection point for Cingulate as we advance toward regulatory submission and commercialization.” Last month Cingulate announced positive top-line results of a high dose (50-mg) food effect study for CTx-1301, with the primary endpoints establishing that it can be taken with or without food…Read full documentShow less
Subjects Demonstrated Marked Improvement of ADHD Symptoms at Week 5New Drug Application on Schedule for this Summer CING CEO Shares Insights and Strategic Outlook on “Unboxing Biotech” Podcast KANSAS CITY, Kan., May 20, 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 the efficacy results from an FDA required Phase 3, randomized, fixed dose, double blind, placebo controlled clinical study in pediatrics (aged 6-17), for its lead asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The primary efficacy endpoint of the study was change in total score on the ADHD-RS-5 rating scale (a scale which measures aspects of ADHD in pediatrics). The fixed doses used in the study were 18.75-mg; 25-mg and 37.5-mg. Pending approval by the FDA, Cingulate expects to launch CTx-1301 with a total of eight dosage strengths, six of which are expected to treat patients under the age of 18. "In a randomized, double-blind, placebo-controlled Phase 3 trial in pediatric ADHD patients, CTx-1301 demonstrated statistically significant improvements in ADHD symptoms across all fixed doses, achieving robust effect sizes (0.737 to 1.185) within 5 weeks,” said Cingulate Chief Science Officer Raul R. Silva, MD. “These results illustrate that CTx-1301, if approved by the FDA, is positioned to become a potential first-line treatment for providers to overcome the longstanding unmet needs facing the millions of ADHD patients worldwide.” Cingulate Chairman and CEO Shane J. Schaffer stated, “These compelling results once again validate the therapeutic benefits and commercial potential of CTx-1301. Achieving statistically significant outcomes and remarkable effect sizes across all tested dose levels illustrates the potential benefits of our product and the value of our Precision Timed Release ™ Platform. These findings represent a significant value inflection point for Cingulate as we advance toward regulatory submission and commercialization.” Last month Cingulate announced positive top-line results of a high dose (50-mg) food effect study for CTx-1301, with the primary endpoints establishing that it can be taken with or without food. In March, Cingulate released Phase 3 safety data for CTx-1301, demonstrating that the safety profile of CTx-1301 has remained consistent over the course of eight clinical trials. A final analysis that combines both adult and pediatric safety and efficacy data will be prepared and included in the NDA submission planned for this summer. About the Phase 3 Children/Adolescent Fixed Dose Study (CTx-1301-005) Efficacy results from an FDA required Phase 3, randomized, fixed dose, double blind, placebo controlled clinical study in pediatrics (aged 6-17). The primary efficacy endpoint in this study was change of the ADHD-RS-5 total score from Study Day 0 to Week 5. The ADHD-RS-5 is a scale which measures various aspects of ADHD in pediatrics. The fixed doses used in the study were 18.75-mg; 25.0-mg and 37.5-mg. The protocol originally required enrollment of 385 subjects, however with FDA guidance the study was terminated early resulting in the intent to treat the (ITT) population of 103 subjects in the completed study. Within 5 weeks of subjects receiving once daily dosing of CTx-1301 the p-values for ADHD-RS-5 were 0.018, 0.011 and 0.001 for the 18.75-mg, 25-mg, and 37.5-mg doses, respectively. This level of significance was achieved with less than one third of the planned subjects. In this study, the pre-defined statistical parameter that determined success using the ADHD-RS-5 score at Week 5 compared to Study Day 0 was a p-value of less than 0.017. Effect size represents the magnitude of a change in an outcome, or the strength of a relationship which was calculated for the ADHD-RS-5 primary endpoint versus placebo for each dose at week 5. The mean effect size for long-acting stimulants was 0.73. (J of Clin Psychiatry; 71:6, June 2010). In this study the statistically significant mean effect size compared to placebo at week 5 was: 0.737 at 18.75-mg; 0.782 at 25-mg; 1.185 at 37.5-mg; an overall effect size of 0.901. The Clinical Global Impression scale (CGI-I) is an objective measure of a patient’s change (improvement or worsening) in ADHD symptoms compared to baseline and was monitored during the study. The results of the CGI-I demonstrated that at all tested doses subjects demonstrated an improvement versus the placebo group at week 5. About Attention Deficit/Hyperactivity Disorder (ADHD)ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65–90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined. About CTx-1301Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off. About Precision Timed Release™ (PTR™) Platform TechnologyCingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, OralogiK™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here. About Cingulate Inc.Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on 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 & Public Relations:Thomas DaltonVice President, Investor & Public Relations, [email protected](913) 942-2301 Matt KrepsDarrow [email protected](214) 597-8200
Investor releaseQuarter not tagged2025-05-09Cingulate Inc. Reports First Quarter 2025 Financial Results and Provides an Updated Timeline of Key Developments for its lead ADHD and Anxiety Assets
GlobeNewswire
Cingulate Inc. Reports First Quarter 2025 Financial Results and Provides an Updated Timeline of Key Developments for its lead ADHD and Anxiety Assets
Pre-NDA Meeting for CTx-1301(dexmethylphenidate) Held April 2, 2025; New Drug Application Submission Targeted for Mid-2025 Non-Dilutive Funding to Accelerate Development of CTx-2103 (buspirone) KANSAS CITY, Kan., May 08, 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 its financial results for the quarter ended March 31, 2025, and provided a clinical and business update. Highlights include the completion of the Pre-NDA meeting for CTx-1301 and grant received to accelerate development of CTx-2103. “The first quarter of 2025 has been a very constructive one for Cingulate,” stated Chairman and CEO Shane J. Schaffer. “We held a productive meeting with the FDA last month and remain on target to file an NDA in the middle of the year for our lead ADHD asset CTx-1301. The results announced from a food effect study of 50mg CTx-1301 – our largest dose – were positive and consistent with previous fed/fast data (25mg CTx-1301). We were also pleased to receive a $3 million grant of non-dilutive funding for the development of CTx-2103 for the treatment of anxiety, advancing our pipeline and illustrating the applicability of Cingulate’s PTR™ platform.” Cingulate Completes Pre-NDA Meeting with FDA to Discuss New Drug Application (NDA) for lead ADHD Asset CTx-1301 and Remains on Track to Submit the NDA Mid-2025 and Provides additional Clinical Updates On April 2, 2025, Cingulate completed its Pre-NDA meeting with the FDA to discuss the submission of an NDA for CTx-1301, its lead asset for the treatment of ADHD. This important milestone keeps Cingulate on track for a mid-2025 submission of the NDA for CTx-1301. In March 2025, Cingulate released Phase 3 safety data for CTx-1301, showing that the safety profile of CTx-1301 has remained consistent over the course of nine clinical trials. In late April 2025, Cingulate reported that the primary endpoint of the 50mg food effect study demonstrated that CTx-1301 can be taken with or without food. Cingulate Receives $3 million Grant from Private Foundation to Accelerate Development of Anxiety Asset CTx-2103 (buspirone) In April 2025, Cingulate received a $3 million grant to accelerate the development of CTx-2103 (buspi…Read full documentShow less
Pre-NDA Meeting for CTx-1301(dexmethylphenidate) Held April 2, 2025; New Drug Application Submission Targeted for Mid-2025 Non-Dilutive Funding to Accelerate Development of CTx-2103 (buspirone) KANSAS CITY, Kan., May 08, 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 its financial results for the quarter ended March 31, 2025, and provided a clinical and business update. Highlights include the completion of the Pre-NDA meeting for CTx-1301 and grant received to accelerate development of CTx-2103. “The first quarter of 2025 has been a very constructive one for Cingulate,” stated Chairman and CEO Shane J. Schaffer. “We held a productive meeting with the FDA last month and remain on target to file an NDA in the middle of the year for our lead ADHD asset CTx-1301. The results announced from a food effect study of 50mg CTx-1301 – our largest dose – were positive and consistent with previous fed/fast data (25mg CTx-1301). We were also pleased to receive a $3 million grant of non-dilutive funding for the development of CTx-2103 for the treatment of anxiety, advancing our pipeline and illustrating the applicability of Cingulate’s PTR™ platform.” Cingulate Completes Pre-NDA Meeting with FDA to Discuss New Drug Application (NDA) for lead ADHD Asset CTx-1301 and Remains on Track to Submit the NDA Mid-2025 and Provides additional Clinical Updates On April 2, 2025, Cingulate completed its Pre-NDA meeting with the FDA to discuss the submission of an NDA for CTx-1301, its lead asset for the treatment of ADHD. This important milestone keeps Cingulate on track for a mid-2025 submission of the NDA for CTx-1301. In March 2025, Cingulate released Phase 3 safety data for CTx-1301, showing that the safety profile of CTx-1301 has remained consistent over the course of nine clinical trials. In late April 2025, Cingulate reported that the primary endpoint of the 50mg food effect study demonstrated that CTx-1301 can be taken with or without food. Cingulate Receives $3 million Grant from Private Foundation to Accelerate Development of Anxiety Asset CTx-2103 (buspirone) In April 2025, Cingulate received a $3 million grant to accelerate the development of CTx-2103 (buspirone) for the treatment of anxiety, to be paid in three installments of $1 million each. The first $1 million installment is expected to be received in May 2025, and will be used to fund a formulation study of CTx-2103. The second $1 million installment is expected to be received upon completion of a formulation study for CTx-2103 and the third $1 million installment is expected to be received upon completion of development batches required for the IND (Investigational New Drug Application) for CTx-2103. This grant is projected to cover the costs of the development of CTx-2103 through mid-2026, the targeted timing of the IND for CTx-2103. The foundation will receive a future royalty contingent on the commercialization of CTx-2103, beginning six months after the first commercial sale of CTx-2103, payable at $500,000 per quarter, with a maximum cumulative royalty of $3.5 million. CTx-2103 has the potential to be the first, once-daily formulation of buspirone, one of the most widely prescribed agents in the $5.5 billion US anxiety market ($11.6 billion globally). CTx-2103 also presents an alternative to the use of benzodiazepines and associated withdrawal and dependency issues. FIRST QUARTER RESULTS Cash Position: As of March 31, 2025, Cingulate had approximately $9.5 million in cash and cash equivalents, a $2.7 million decrease from December 31, 2024 and cash runway into the fourth quarter of 2025, beyond its targeted submission of the NDA for CTx-1301. Working Capital (current assets less current liabilities): As of March 31, 2025, Cingulate had approximately $4.9 million in working capital as compared to $7.7 million as of December 31, 2024. This decrease in working capital was primarily due to the use of cash to support operations, which was partially offset by capital raised during the quarter. Cingulate believes working capital is meaningful to investors as a measure of short-term financial health. R&D Expenses: Research and development expenses were $2.2 million for the three months ended March 31, 2025, an increase of $0.4 million or 23.0% from the three months ended March 31, 2024. This change was primarily the result of an increase in personnel expenses and development costs in the three months ended March 31, 2025 as compared to the same period in 2024. The increase in personnel costs was the result of the reinstatement of base salaries in September 2024 following salary reduction measures that were implemented in late 2023. Regulatory costs increased in the three months ended March 31, 2025 as compared to the same period in 2024 due to preparation for the pre-NDA meeting with the FDA G&A Expenses: G&A expenses were $1.5 million for the three months ended March 31, 2025, an increase of $0.3 million or 30.0% from the three months ended March 31, 2024. This is primarily the result of an increase in professional fees and personnel expenses. The increase in personnel costs is the result of reinstatement of base salaries in September 2024 as noted above. Net Loss: Net loss was $3.8 million for the three months ended March 31, 2025, compared to $3.0 million for the three months ended March 31, 2024. The increase in the net loss relates to increased development activity as well as the reinstatement of base salaries in September 2024. as noted above. About Attention Deficit/Hyperactivity Disorder (ADHD)ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined. About CTx-1301 Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off. About Precision Timed Release™ (PTR™) Platform Technology Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here. About Cingulate Inc. Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on 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 & Public Relations: Thomas Dalton Vice President, Investor & Public Relations, Cingulate [email protected] (913) 942-2301 Matt Kreps Darrow Associates [email protected] (214) 597-8200
Investor releaseQuarter not tagged2025-04-29Cingulate Announces Positive Top-Line Results from High-Dose (50mg) Fed/Fast Study of Lead Asset CTx-1301 for ADHD
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Cingulate Announces Positive Top-Line Results from High-Dose (50mg) Fed/Fast Study of Lead Asset CTx-1301 for ADHD
Primary Endpoints Demonstrate CTx-1301 Can be Taken With or Without Food CTx-1301 is Designed as a True, Entire Active-Day Treatment for ADHD KANSAS CITY, Kan., April 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, today announced positive top-line results from the CTx-1301-013 study, an FDA required study, assessing the effect of food on absorption of the highest dose (50mg) of its lead candidate CTx-1301. CTx-1301 is a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate, a compound approved by the U.S. Food and Drug Administration (FDA) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The trial demonstrated that 50mg CTx-1301 can be taken with or without food. Multiple pharmacokinetic (PK) measurements were taken, and adverse events were consistent with previous findings and indicate a favorable tolerability profile. “We are developing CTx-1301 to be the first true, once-daily stimulant medication that treats ADHD over an entire active day, and that offers eight dose strengths so that medical professionals can effectively optimize a patient’s medication. Crucial to this is ensuring a pharmacokinetic profile customized for the unique attributes of stimulant medications and ADHD, regardless of food intake,” said Shane J. Schaffer, PharmD, Chairman and CEO, Cingulate. “The results of this study confirm that we have identified the optimal formulation of 50mg CTx-1301.” CTx-1301 Pharmacokinetics in Both Fed and Fasted StatesThe CTx-1301-013 study enrolled 27 healthy adult subjects, male and female, (age range: 18 to 50 years) who were randomized into one of two sequences to receive a single 50 mg dose of CTx-1301 on two occasions (once with a standard high fat breakfast and once on an empty stomach). Both doses were administered with 8 oz of water and frequent blood samples were obtained for a period of 28 hours after each dose in order to define the absorption and elimination profile of dexmethylphenidate (i.e. the pharmacokinetics or PK). The primary PK endpoints of this study were the maximum plasma concentration achieved after each dose (Cmax) as well as the extent of dexmethylphenidate absorb…Read full documentShow less
Primary Endpoints Demonstrate CTx-1301 Can be Taken With or Without Food CTx-1301 is Designed as a True, Entire Active-Day Treatment for ADHD KANSAS CITY, Kan., April 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, today announced positive top-line results from the CTx-1301-013 study, an FDA required study, assessing the effect of food on absorption of the highest dose (50mg) of its lead candidate CTx-1301. CTx-1301 is a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate, a compound approved by the U.S. Food and Drug Administration (FDA) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The trial demonstrated that 50mg CTx-1301 can be taken with or without food. Multiple pharmacokinetic (PK) measurements were taken, and adverse events were consistent with previous findings and indicate a favorable tolerability profile. “We are developing CTx-1301 to be the first true, once-daily stimulant medication that treats ADHD over an entire active day, and that offers eight dose strengths so that medical professionals can effectively optimize a patient’s medication. Crucial to this is ensuring a pharmacokinetic profile customized for the unique attributes of stimulant medications and ADHD, regardless of food intake,” said Shane J. Schaffer, PharmD, Chairman and CEO, Cingulate. “The results of this study confirm that we have identified the optimal formulation of 50mg CTx-1301.” CTx-1301 Pharmacokinetics in Both Fed and Fasted StatesThe CTx-1301-013 study enrolled 27 healthy adult subjects, male and female, (age range: 18 to 50 years) who were randomized into one of two sequences to receive a single 50 mg dose of CTx-1301 on two occasions (once with a standard high fat breakfast and once on an empty stomach). Both doses were administered with 8 oz of water and frequent blood samples were obtained for a period of 28 hours after each dose in order to define the absorption and elimination profile of dexmethylphenidate (i.e. the pharmacokinetics or PK). The primary PK endpoints of this study were the maximum plasma concentration achieved after each dose (Cmax) as well as the extent of dexmethylphenidate absorbed into the blood expressed as the area the plasma drug concentration vs. time curve (AUC). Knowledge of these two PK parameters which define maximum and total extent of exposure are essential for a drug’s regulatory approval. “Similar to the 25mg fasted versus fed study conducted with CTx-1301 (NCT04449250), the 50mg dose of CTx-1301 demonstrated that it may also be taken with or without food, however patients should be advised to take the medication consistently as such," said Raul Silva, MD, Chief Science Officer, Cingulate. “Most importantly is that the unique formulation of CTx-1301 is bioavailable irrespective of the presence of food intake and this study provides important clinical knowledge for providers in the treatment of ADHD patients.” Full results, including data on secondary endpoints measuring half-life and time to onset, will be submitted for presentation at a forthcoming medical meeting. About Attention Deficit/Hyperactivity Disorder (ADHD)ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65–90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined. About CTx-1301Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off. About Precision Timed Release™ (PTR™) Platform TechnologyCingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here. About Cingulate Inc.Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on 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 & Public Relations:Thomas DaltonVice President, Investor & Public Relations, [email protected](913) 942-2301 Matt KrepsDarrow [email protected](214) 597-8200

