Cingulate Inc.

Previous wording

We are a biopharmaceutical company using our proprietary Precision Timed Release TM (PTRTM) 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 Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety, we are identifying and evaluating additional therapeutic areas where our PTR technology may be employed to develop future product candidates. Our PTR platform incorporates a proprietary Erosion Barrier Layer (EBL) designed to allow for the release of drug substance at specific, pre-defined time intervals, unlocking the potential for once-daily, multi-dose tablets. We believe there remains a significant, unmet need within the current treatment paradigm for true once-daily ADHD stimulant medications with lasting duration and a superior side effect profile to better serve the needs of patients throughout their entire active-day.

Current wording

We are a biopharmaceutical company using our proprietary Precision Timed Release TM (PTRTM) 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 Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety, we are identifying and evaluating additional therapeutic areas where our PTR technology may be employed to develop future product candidates. Our PTR platform incorporates a proprietary Erosion Barrier Layer designed to allow for the release of drug substance at specific, pre-defined time intervals, unlocking the potential for once-daily, multi-dose tablets. We believe there remains a significant, unmet need within the current treatment paradigm for true once-daily ADHD stimulant medications with lasting duration and a superior side effect profile to better serve the needs of patients throughout their entire active-day.

Previous wording

Since inception in 2012, our operations have focused on developing our product candidates, primarily CTx-1301, organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio and conducting clinical trials. We do not have any product candidates approved for sale and have not generated any revenue. We have funded our operations through public and private capital raised. Cumulative capital raised from these sources, including debt financing, was approximately $113.5 million as of June 30, 2025.

Current wording

Since inception in 2012, our operations have focused on developing our product candidates, primarily CTx-1301, organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio and conducting clinical trials. We do not have any product candidates approved for sale and have not generated any revenue. We have funded our operations through public and private capital raised. Cumulative capital raised from these sources, including debt financing, was approximately $116.1 million as of September 30, 2025.

Previous wording

We have incurred significant losses since our inception. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and commercialization of one or more of our product candidates. Our net losses were $4.8 million and $3.2 million for the three months ended June 30, 2025 and 2024, respectively. See “Results of Operations” below for an explanation of the fluctuations in our net losses. As of June 30, 2025, we had an accumulated deficit of $117.1 million.

Current wording

We have incurred significant losses since our inception. Our net losses were $7.3 million and $4.1 million for the three months ended September 30, 2025 and 2024, respectively. See “Results of Operations” below for an explanation of the fluctuations in our net losses. As of September 30, 2025, we had an accumulated deficit of $126.1 million.

Previous wording

We filed our NDA for CTx-1301 with the FDA on July 31, 2025 and believe our cash will satisfy our capital needs into late 2025 under our current business plan. To advance our commercialization efforts for CTx-1301 into early 2026, we will need to raise approximately $1.5 million of additional capital. We will also need additional capital to advance our other programs. See “Liquidity and Capital Resources” below.

Current wording

Taking into account the $6 million we received from the debt issuance described below, we believe our cash will satisfy our capital needs into the second quarter of 2026 under our current business plan. To advance our commercialization efforts for CTx-1301 through our Prescription Drug User Fee Act (PDUFA) date of May 31, 2026, we believe we will need to raise approximately $9 million of additional capital. We will also need additional capital to advance our other programs. See “Liquidity and Capital Resources” below.

Previous wording

Our ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of our product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, including potential collaborations with other companies or other strategic transactions. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our product candidates.

Current wording

Our ability to generate revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of our product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, including potential collaborations with other companies or other strategic transactions. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our product candidates.

Previous wording

On August 7, 2025, the employment of Laurie A. Myers, our former Executive Vice President and Chief Operating Officer, terminated.

Current wording

On August 7, 2025, the employment of Laurie A. Myers, our former Executive Vice President and Chief Operating Officer, was terminated.

Previous wording

On August 9, 2025, Shane Schaffer, Chairman and Chief Executive Officer, was charged with one count of aggravated domestic battery. On August 14, 2025, the Board (i) placed Shane Schaffer on administrative leave pending the resolution of the legal proceedings, (ii) appointed Jennifer Callahan, our current Chief Financial Officer, to serve as interim Chief Executive Officer, effective immediately and (iii) appointed John A. Roberts, a current member of the Board, to serve as Executive Chairman of the Board, effective immediately. Ms. Callahan will continue to serve as Chief Financial Officer while serving as interim Chief Executive Officer until further action by the Board. In his role as Executive Chairman, Mr. Roberts will among other services, provide operational support to our executive management team.

Current wording

On August 9, 2025, Shane Schaffer, Chairman and Chief Executive Officer, was charged with one count of aggravated domestic battery. On August 14, 2025, the Board (i) placed Shane Schaffer on administrative leave pending the resolution of the legal proceedings, (ii) appointed Jennifer Callahan, our current Chief Financial Officer, to serve as interim Chief Executive Officer and (iii) appointed John A. Roberts, a current member of the Board, to serve as Executive Chairman of the Board. Ms. Callahan will continue to serve as Chief Financial Officer while serving as interim Chief Executive Officer until further action by the Board. In his role as Executive Chairman, Mr. Roberts will among other services, provide operational support to our executive management team. On October 28, 2025, Dr. Schaffer’s charge was amended to one count of domestic battery (misdemeanor).

Previous wording

We initiated two CTx-1301 Phase 3 clinical studies in pediatric and adolescent patients- a fixed dose study and a dose-optimized onset and duration study in a laboratory classroom setting in the third quarter of 2023. Based upon written communication with the FDA that further conduct of these pediatric and adolescent studies is not required for the submission of an NDA, we closed enrollment on both Phase 3 trials. Analysis of the safety data from the two closed Phase 3 trials and the 50mg dose food effect study revealed that no subjects experienced a serious treatment emergent adverse event (TEAE), a serious TEAE or a TEAE leading to death and there were no clinically relevant trends in TEAEs overall. A final analysis that combines both adult and pediatric safety and efficacy data was included in the NDA submission for CTx-1301.

Current wording

We initiated two CTx-1301 Phase 3 clinical studies in pediatric and adolescent patients- a fixed dose study and a dose-optimized onset and duration study in a laboratory classroom setting in the third quarter of 2023. Based upon written communication with the FDA that further conduct of these pediatric and adolescent studies is not required for the submission of an NDA, we closed enrollment on both Phase 3 trials. Analysis of the safety data from the two closed Phase 3 trials and the 50mg dose food effect study revealed that no subjects experienced a serious treatment emergent adverse event (TEAE), a serious TEAE or a TEAE leading to death and there were no clinically relevant trends in TEAEs overall. A final analysis that combines both adult and pediatric safety and efficacy data was included in the NDA submission for CTx-1301 which was submitted to the FDA on July 31, 2025. The FDA accepted for review the NDA for CTx-1301 and assigned a PDUFA target action date of May 31, 2026.

Previous wording

**CTx-2103:**We have embarked on a program to develop CTx-2103 (buspirone), for the treatment of anxiety, the most common mental health disorder in the United States. We completed a formulation study in which the pharmacokinetics were evaluated for this trimodal tablet providing three precisely timed doses of buspirone versus one immediate release dose. In addition, scintigraphic imaging visualized transit of the tablets through the gastrointestinal tract to confirm both the site and onset of release, which will then be correlated with pharmacokinetic data to establish the full release profile of the CTx-2103 formulation. Based on the pharmacokinetic profile seen in the data, CTx-2103 achieved a triple release of buspirone. These results provided the critical information required to allow us to request a Pre-IND meeting with the FDA to discuss the design of our clinical and regulatory program for CTx-2103 which occurred in the fourth quarter of 2023. We received input from the FDA regarding the regulatory pathway for CTx-2103, and the design of clinical studies for filing of an IND. Based on this FDA feedback, we believe that we can seek and win approval of CTx-2103 under the 505(b)(2) pathway, which typically requires less time and resources than the 505(b)(1) full NDA pathway. Additional capital resources will be required to continue the development of this product candidate.

Current wording

**CTx-2103:**We have embarked on a program to develop CTx-2103 (buspirone), for the treatment of anxiety, the most common mental health disorder in the United States. We completed a formulation study in which the pharmacokinetics were evaluated for this trimodal tablet providing three precisely timed doses of buspirone versus one immediate release dose. In addition, scintigraphic imaging visualized transit of the tablets through the gastrointestinal tract to confirm both the site and onset of release, which will then be correlated with pharmacokinetic data to establish the full release profile of the CTx-2103 formulation. Based on the pharmacokinetic profile seen in the data, CTx-2103 achieved a triple release of buspirone. These results provided the critical information required to allow us to request a Pre-IND (Investigational New Drug) meeting with the FDA to discuss the design of our clinical and regulatory program for CTx-2103 which occurred in the fourth quarter of 2023. We received input from the FDA regarding the regulatory pathway for CTx-2103, and the design of clinical studies for filing of an IND. Based on this FDA feedback, we believe that we can seek and win approval of CTx-2103 under the 505(b)(2) pathway, which typically requires less time and resources than the 505(b)(1) full NDA pathway. Additional capital resources will be required to continue the development of this product candidate.

Previous wording

We entered into an At The Market Offering Agreement (ATM Agreement) with H.C. Wainwright & Co., LLC (HCW), as sales agent, in January 2023 as amended in May 2023, pursuant to which we may offer and sell, from time to time through HCW, shares of our common stock for aggregate proceeds of up to $23.5 million based on prospectus supplements filed with the SEC through the date of this report (upon the terms and subject to the conditions and limitations set forth in the ATM Agreement). In the three months ended June 30, 2025, we sold 364,963 shares of common stock under the ATM Agreement, for net proceeds of $1,578,731, after deducting $54,363 of compensation to HCW and other administration fees. Subsequent to June 30, 2025, we sold 64,682 shares of common stock under the ATM Agreement, for net proceeds of $340,253, after deducting $12,527 of compensation to HCW and other administration fees.

Current wording

We entered into an At The Market Offering Agreement (ATM Agreement) with H.C. Wainwright & Co., LLC (HCW), as sales agent, in January 2023 as amended in May 2023, pursuant to which we may offer and sell, from time to time through HCW, shares of our common stock for aggregate proceeds of up to $23.5 million based on prospectus supplements filed with the SEC through the date of this report (upon the terms and subject to the conditions and limitations set forth in the ATM Agreement). In the three months ended September 30, 2025, we sold 82,048 shares of common stock under the ATM Agreement, for net proceeds of $412,996, after deducting $15,346 of compensation to HCW and other administration fees. Subsequent to September 30, 2025, we sold 138,289 shares of common stock under the ATM Agreement, for net proceeds of $562,479, after deducting $19,113 of compensation to HCW and other administration fees.

Previous wording

In April 2023, we entered into a purchase agreement (Original LP Purchase Agreement) with Lincoln Park Capital Fund LLC (Lincoln Park). Pursuant to the Original LP Purchase Agreement, Lincoln Park agreed to purchase from us up to an aggregate of $12.0 million of common stock (upon the terms and subject to the conditions and limitations set forth in the Original LP Purchase Agreement) from time to time and at our sole discretion over the 36-month term of the Original LP Purchase Agreement. During the quarter ended June 30, 2025, we sold 674,006 shares of common stock under the Original LP Purchase Agreement, for net proceeds of $2,613,247. As of June 30, 2025, the Company sold to Lincoln Park the maximum dollar value worth of common stock pursuant to the Original LP Purchase Agreement, and the Original LP Purchase Agreement thereupon expired in accordance with its terms

Current wording

In April 2023, we entered into a purchase agreement (Original LP Purchase Agreement) with Lincoln Park Capital Fund LLC (Lincoln Park). Pursuant to the Original LP Purchase Agreement, Lincoln Park agreed to purchase from us up to an aggregate of $12.0 million of common stock. As of June 30, 2025, the Company sold to Lincoln Park the maximum dollar value worth of common stock pursuant to the Original LP Purchase Agreement, and the Original LP Purchase Agreement thereupon expired in accordance with its terms

Previous wording

On July 21, 2025, we entered into a new purchase agreement with Lincoln Park (2025 LP Purchase Agreement), pursuant to which Lincoln Park has agreed to purchase from the Company up to an aggregate of $25.0 million of common stock (subject to certain limitations and satisfaction of the conditions set forth in the 2025 LP Purchase Agreement) from time to time and at the Company’s sole discretion over the 36-month term of the 2025 LP Purchase Agreement. Pursuant to the terms of the 2025 LP Purchase Agreement, the Company issued 120,424 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of common stock under the 2025 LP Purchase Agreement. In August 2025, we sold 69,389 shares of common stock to Lincoln Park, under the 2025 LP Purchase Agreement, for net proceeds of $349,998.

Current wording

On July 21, 2025, we entered into a second purchase agreement with Lincoln Park (2025 LP Purchase Agreement), pursuant to which Lincoln Park has agreed to purchase from the Company up to an aggregate of $25.0 million of common stock (subject to certain limitations and satisfaction of the conditions set forth in the 2025 LP Purchase Agreement) from time to time and at the Company’s sole discretion over the 36-month term of the 2025 LP Purchase Agreement. Pursuant to the terms of the 2025 LP Purchase Agreement, the Company issued 120,424 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of common stock under the 2025 LP Purchase Agreement. During the quarter ended September 30, 2025, we sold 291,109 shares of common stock to Lincoln Park, under the 2025 LP Purchase Agreement, for net proceeds of $1,147,727. Subsequent to September 30, 2025, we sold 561,839 shares of common stock to Lincoln Park, under the 2025 LP Purchase Agreement, for net proceeds of $2,090,280.

Previous wording

Subsequent to June 30, 2025, the Company entered into five separate agreements with Streeterville Capital, LLC to exchange an aggregate of $1,225,000 in principal for 268,738 shares of common stock, thereby extinguishing that portion of the promissory note with Streeterville Capital.

Current wording

During the quarter ended September 30, 2025, the Company entered into exchange agreements with Streeterville Capital, LLC to exchange an aggregate of $2,475,000 in principal for 594,487 shares of common stock, thereby extinguishing that portion of the promissory note with Streeterville Capital. Subsequent to September 30, 2025, the Company entered into exchange agreements with Streeterville Capital to exchange an aggregate of $850,000 in principal for 218,917 shares of common stock, thereby extinguishing that portion of the promissory note with Streeterville Capital.

Previous wording

Since inception, we have not generated any revenue and do not expect to generate any revenue from the sale of products in the near future. If our development efforts for our product candidates are successful and result in regulatory approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from collaboration of license agreements.

Current wording

Since inception, we have not generated any revenue and do not expect to generate any revenue from the sale of products in the near future. If our development efforts for our product candidates are successful and result in regulatory approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from collaboration of license agreements. The FDA accepted for review the NDA for CTx-1301 and assigned a PDUFA target action date of May 31, 2026.

Previous wording

Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase for the foreseeable future as we continue clinical development for our product candidates, as well as adding additional PTR product candidates to our pipeline. As products enter later stages of clinical development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Historically, our research and development costs have primarily related to the development of CTx-1301. As we advance CTx-1301, CTx-1302, and CTx-2103, as well as identify any other potential product candidates, we will continue to allocate our direct external research and development costs to the products. We expect to fund our research and development expenses from our current cash and cash equivalents and any future equity or debt financings, or other capital sources.

Current wording

Research and development activities are central to our business model. Subject to successful regulatory approval and commercialization of CTx-1301, we expect that our research and development expenses will continue to increase as we continue clinical development for our product candidates, as well as adding additional PTR product candidates to our pipeline. As products enter later stages of clinical development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Historically, our research and development costs have primarily related to the development of CTx-1301. As we advance CTx-1301, CTx-1302, and CTx-2103, as well as identify any other potential product candidates, we will continue to allocate our direct external research and development costs to the products. We expect to fund our research and development expenses from our current cash and cash equivalents and any future equity or debt financings, or other capital sources.

Previous wording

We expect that our general and administrative expenses will increase in the future as we increase our general and administrative headcount to support our growing operations including the potential commercialization of our product candidates. We have experienced, and will continue to experience, increased expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax compliance services; director and officer insurance; and investor and public relations costs.

Current wording

We expect that our general and administrative expenses will increase in the near future as we increase our general and administrative headcount to support our growing operations, including the potential commercialization of CTx-1301. We have experienced, and will continue to experience, increased expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax compliance services; director and officer insurance; and investor and public relations costs.

Previous wording

Interest and other income (expense), net

Current wording

Issuance cost and change in fair value of derivative and interest and other income (expense), net

Previous wording

Interest and other income (expense), net consisted of interest expense on our related party notes payable until the last of those obligations were converted to equity in the first quarter of 2024, and interest expense on the promissory note executed in December of 2024, offset by interest earned on our cash and cash equivalents, including money market funds. The primary objective of our investment policy is liquidity and capital preservation.

Current wording

Issuance cost and change in fair value of derivative relates to the consideration for Lincoln Park’s commitment to purchase shares under the 2025 LP Purchase Agreement and the change in fair value of the derivative asset or liability. Interest and other income (expense), net consists of interest expense on our notes payable and interest earned on our cash and cash equivalents, including money market funds. The primary objective of our investment policy is liquidity and capital preservation.

Previous wording

R&D 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 primarily the result of an increase in clinical operations and regulatory costs in the three months ended June 30, 2025 as compared to the same period in 2024, which was partially offset by a decrease in manufacturing costs. The increase in clinical operations costs is the result of the close-out and analytical activities required for NDA submission related to two Phase 3 studies for CTx-1301, the fixed dose pediatric and adolescent safety and efficacy study and the pediatric does optimization and duration study. Regulatory costs increased in the three months ended June 30, 2025 as compared to the same period in 2024 due to preparation for the pre-NDA meeting with the FDA and NDA submission during the first quarter of 2025. The decrease in manufacturing costs in the three months ended June 30, 2025 as compared to the same period in 2024 was due to more significant manufacturing costs in 2024 related to the completion of registration batches of CTx-1301.

Current wording

R&D 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 primarily the result of an increase in personnel expenses, manufacturing costs and regulatory costs in the three months ended September 30, 2025 as compared to the same period in 2024. 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 when the payment became probable. 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.

Previous wording

Total interest and other income (expense), net for the six months ended June 30, 2025 and June 30, 2024 relates to interest incurred on outstanding notes payable, offset by interest earned on invested balances. The increase in interest expense for the period ended June 30, 2025 is related to interest expense incurred on the promissory note which was executed in December 2024.

Current wording

Issuance cost and change in fair value of derivative for the three months ended September 30, 2025 and September 30, 2024 relates to the consideration for Lincoln Park’s commitment to purchase shares under the 2025 LP Purchase Agreement and the change in fair value of the derivative asset or liability. Interest and other income (expense), net for the three months ended September 30, 2025 and September 30, 2024 relates to interest incurred on the outstanding note payable, offset by interest earned on invested balances. The increase in interest expense for the period ended September 30, 2025 is related to interest expense incurred on the promissory note which was executed in December 2024, including loss on debt extinguishments.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 :

Previous wording

The following table summarizes our R&D expenses for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our R&D expenses for the nine months ended September 30, 2025 and 2024:

Previous wording

R&D expenses were $4.9 million for the six months ended June 30, 2025, an increase of $1.2 million or 33.5% from the six months ended June 30, 2024. This change was primarily the result of an increase in clinical operations, personnel expenses and regulatory costs in the six months ended June 30, 2025 as compared to the same period in 2024, which were partially offset by a decrease in manufacturing costs. The increase in clinical operations costs is the result of the close-out and analytical activities required for NDA submission related to two Phase 3 studies for CTx-1301, the fixed dose pediatric and adolescent safety and efficacy study and the pediatric does optimization and duration study. Regulatory costs increased in the six months ended June 30, 2025 as compared to the same period in 2024 due to preparation for the pre-NDA meeting with the FDA and NDA submission. Personnel costs increased in the six months ended June 30, 2025 as compared to the same period in 2024 due to the reinstatement of base salaries in September 2024 following salary reduction measures which had been implemented in late 2023. The decrease in manufacturing costs in the six months ended June 30, 2025 as compared to the same period in 2024 was due to more significant manufacturing costs in 2024 related to the completion of registration batches of CTx-1301.

Current wording

R&D expenses were $7.8 million for the nine months ended September 30, 2025, an increase of $2.7 million or 51.9% from the nine months ended September 30, 2024. This change was primarily the result of an increase in personnel expenses, regulatory costs and clinical operations in the nine months ended September 30, 2025 as compared to the same period in 2024. Personnel costs increased due to separation costs for an executive in August 2025, costs related to the contingent bonus plan, which were accrued upon the NDA submission of CTx-1301 in the third quarter of 2025 when the payment became probable and the reinstatement of base salaries in September 2024 following salary reduction measures which had been implemented in late 2023. Regulatory costs increased due to preparation for the pre-NDA meeting with the FDA in the second quarter of 2025 and the NDA submission. The increase in clinical operations costs is the result of the close-out and analytical activities required for NDA submission related to two Phase 3 studies for CTx-1301, the fixed dose pediatric and adolescent safety and efficacy study and the pediatric dose optimization and duration study.

Previous wording

The following table summarizes our G&A expenses for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our G&A expenses for the nine months ended September 30, 2025 and 2024:

Previous wording

Total 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 professional fees. The increase in legal and professional fees was due to an increase in certain legal, financial and accounting fees.

Current wording

Total G&A expenses were $6.6 million for the nine months ended September 30, 2025, an increase of $2.3 million or 52.3% from the nine months ended September 30, 2024. This is primarily the result of an increase in personal expenses, legal and professional fees and other expenses. Personnel costs increased 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 when the payment became probable and the reinstatement of base salaries in September 2024 following salary reduction measures which had been implemented in late 2023. The increase in legal and professional fees was due to an increase in certain financial, accounting and legal fees. Other costs increased primarily due to commercial costs related to our contract with Indegene.

Previous wording

Total interest and other income (expense), net for the three months ended June 30, 2025 and June 30, 2024 relates to interest incurred on the outstanding notes payable, offset by interest earned on invested balances. The increase in interest expense for the period ended June 30, 2025 is related to interest expense incurred on the promissory note which was executed in December 2024.

Current wording

Issuance cost and change in fair value of derivative for the nine months ended September 30, 2025 and September 30, 2024 relates to the consideration for Lincoln Park’s commitment to purchase shares under the 2025 LP Purchase Agreement and the change in fair value of the derivative asset or liability. Interest and other income (expense), net for the nine months ended September 30, 2025 and September 30, 2024 relates to interest incurred on outstanding notes payable, offset by interest earned on invested balances. The increase in interest expense for the period ended September 30, 2025 is related to interest expense incurred on the promissory note which was executed in December 2024, including loss on debt extinguishments.

Previous wording

Net cash used in operating activities was $9.5 million for the six months ended June 30, 2025. Cash used in operating activities was primarily due to the use of funds in our operations and to develop CTx-1301 resulting in a net loss of $8.6 million, prior to the effects of two noncash items, stock-based compensation expense of $0.4 million and depreciation expense of $0.3 million. Changes in operating assets and liabilities included a decrease in trade accounts payable and accrued expenses of $0.9 million primarily due to the payment of vendor balances in the first quarter of 2025 and an increase in prepaid expenses and other current assets of $0.9 million primarily due to payments for professional and marketing fees.

Current wording

Net cash used in operating activities was $13.6 million for the nine months ended September 30, 2025. Cash used in operating activities was primarily due to the use of funds in our operations and to develop CTx-1301 resulting in a net loss of $16.2 million, prior to the effects of four noncash items, stock-based compensation expense of $1.1 million, issuance cost and change in fair value of derivative of $1.0 million, loss on debt extinguishment of $0.5 million, accretion of discount on note payable of $0.2 million and depreciation expense of $0.4 million. Changes in operating assets and liabilities included an increase in prepaid expenses and other current assets of $0.9 million primarily due to payments for materials, professional and marketing fees.

Previous wording

Net cash used in operating activities was $10.5 million for the six months ended June 30, 2024. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $6.2 million, prior to the effects of two noncash items, stock-based compensation expense of $0.5 million and depreciation expense of $0.3 million. Changes in operating assets and liabilities included a decrease in trade accounts payable and accrued expenses of $5.3 million due to the payment of vendor balances in the first quarter of 2024 with the cash proceeds from the issuance of common stock pursuant to our ATM Agreement in January 2024 and the issuance of equity in February 2024.

Current wording

Net cash used in operating activities was $14.4 million for the nine months ended September 30, 2024. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $10.3 million, prior to the effects of three noncash items, stock-based compensation expense of $0.9 million, issuance cost and change in fair value of derivative of $0.9 million and depreciation expense of $0.5 million. Changes in operating assets and liabilities included a decrease in trade accounts payable and accrued expenses of $5.5 million primarily due to the payment of vendor balances in the first quarter of 2024 with the cash proceeds from the issuance of common stock pursuant to our ATM Agreement in January 2024 and the issuance of equity in February 2024.

Previous wording

Net cash used in investing activities for both the six-month periods ended June 30, 2025 and June 30, 2024 was primarily related to the purchase of equipment to support our research and development.

Current wording

Net cash used in investing activities for both the nine-month periods ended September 30, 2025 and September 30, 2024 was primarily related to the purchase of equipment to support our research and development.

Previous wording

Net cash provided by financing activities for the six-month period ended June 30, 2025 was related to the cash proceeds from the issuance of common stock pursuant to the ATM Agreement and the Original LP Purchase Agreement.

Current wording

Net cash provided by financing activities for the nine-month period ended September 30, 2025 was related to the cash proceeds from the issuance of common stock pursuant to the ATM Agreement, the Original LP Purchase Agreement and the 2025 LP Purchase Agreement.

Previous wording

Net cash provided by financing activities for the six-month period ended June 30, 2024 was related to the cash proceeds from the issuance of common stock pursuant to the ATM Agreement, the Original LP Purchase Agreement and the issuance of equity in February 2024.

Current wording

Net cash provided by financing activities for the nine-month period ended September 30, 2024 was related to the cash proceeds from the issuance of common stock pursuant to the ATM Agreement, the Original LP Purchase Agreement, the issuance of equity in February 2024 and the warrant inducement transaction in June 2024.

Previous wording

In the three months ended June 30, 2025, we sold 364,963 shares of common stock under the ATM Agreement, for net proceeds of $1,578,731, after deducting $54,363 of compensation to HCW and other administration fees. Subsequent to June 30, 2025, we sold 64,682 shares of common stock under the ATM Agreement, for net proceeds of $340,252, after deducting $12,527 of compensation to HCW and other administration fees.

Current wording

In the three months ended September 30, 2025, we sold 82,048 shares of common stock under the ATM Agreement, for net proceeds of $412,996, after deducting $15,346 of compensation to HCW and other administration fees. Subsequent to September 30, 2025, we sold 138,289 shares of common stock under the ATM Agreement, for net proceeds of $562,479, after deducting $19,113 of compensation to HCW and other administration fees.

Previous wording

As of June 30, 2025, we had cash and cash equivalents of $8.9 million. We believe our cash will satisfy our capital needs into late 2025 under our current business plan. To advance our commercialization efforts for CTx-1301 into early 2026 we will need to raise approximately $1.5 million of additional capital. Changing circumstances may cause us to expend cash significantly faster than we currently anticipate, and we may need to spend more cash than currently expected because of circumstances beyond our control. Our policy is to invest any cash in excess of our immediate requirements in investments designed to preserve the principal balance and provide liquidity while producing a modest return on investment. Accordingly, our cash equivalents are invested primarily in money market funds which are currently providing only a minimal return given the current interest rate environment.

Current wording

As of September 30, 2025, we had cash and cash equivalents of $6.1 million. Taking into account the $6 million we received from our debt issuance to Avondale Capital, LLC on November 7, 2025, we believe our cash will satisfy our capital needs into the second quarter of 2026 under our current business plan. To advance our commercialization efforts through the May 31, 2026 PDUFA date for CTx-1301, we believe we will need to raise approximately $7 million of additional capital. Changing circumstances may cause us to expend cash significantly faster than we currently anticipate, and we may need to spend more cash than currently expected because of circumstances beyond our control. Our policy is to invest any cash in excess of our immediate requirements in investments designed to preserve the principal balance and provide liquidity while producing a modest return on investment. Accordingly, our cash equivalents are invested primarily in money market funds which are currently providing only a minimal return given the current interest rate environment.

Previous wording

We expect to continue to incur substantial additional operating losses for the near term as we continue to develop our product candidates, primarily CTx-1301 and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain marketing approval for our product candidates, we will incur significant sales, marketing and outsourced manufacturing expenses. In addition, we expect to incur additional expenses to add operational, financial and information systems and personnel, including personnel to support our planned product commercialization efforts. We also expect to incur significant costs to comply with corporate governance, internal controls and similar requirements applicable to us as a public company.

Current wording

We expect to continue to incur substantial additional operating losses for the near term as we continue to develop CTx-1301 and seek marketing approval and, subject to obtaining such approval, the eventual commercialization. If we obtain marketing approval for CTx-1301, we will incur significant sales, marketing and outsourced manufacturing expenses. In addition, we expect to incur additional expenses to add operational, financial and information systems and personnel, including personnel to support our planned product commercialization efforts. We also expect to incur significant costs to comply with corporate governance, internal controls and similar requirements applicable to us as a public company.

Previous wording

For example, pursuant to the Note Purchase Agreement with Streeterville Capital, LLC, we are subject to certain restrictions on our ability to issue securities during the term of the promissory note. Specifically, we have agreed, among other things, to refrain from entering into any agreement or covenant that locks up, restricts or otherwise prohibits us from entering into a variable rate transaction with Lender or any of its affiliates, or from issuing common stock or other equity or debt securities to Lender or any of its affiliates. If we breach the Note Purchase Agreement, we may be obligated to indemnify Lender for loss or damage arising as a result of any breach or alleged breach by us of the Note Purchase Agreement, which may affect our business operations and financial condition. Additionally, the promissory note provides that following an event of default under the promissory note, Lender has the right to seek and receive injunctive relief from a court or an arbitrator prohibiting us from issuing any of our common stock or preferred stock to any party unless fifty percent of the gross proceeds received by us in connection with such issuance are simultaneously used to make a payment under the promissory note. Lender also has the right to seek and receive injunctive relief from a court or arbitrator to prevent the consummation of any fundamental transaction, as defined in the promissory note, unless it contains a closing condition that the promissory note is paid in full upon consummation of the transaction or the lender has provided its written consent to such transaction.

Current wording

For example, pursuant to the note purchase agreements with Streeterville Capital, LLC and Avondale Capital, LLC, respectively, we are subject to certain restrictions on our ability to issue securities during the term of the promissory notes. Specifically, we have agreed, among other things, to refrain from entering into any agreement or covenant that locks up, restricts or otherwise prohibits us from entering into a variable rate transaction with the lenders or any of their affiliates, or from issuing common stock or other equity or debt securities to the lenders or any of their affiliates. If we breach the note purchase agreements, we may be obligated to indemnify the lender for loss or damage arising as a result of any breach or alleged breach by us of the note purchase agreements, which may affect our business operations and financial condition. Additionally, the promissory notes provide that following an event of default under the promissory notes, the lenders have the right to seek and receive injunctive relief from a court or an arbitrator prohibiting us from issuing any of our common stock or preferred stock to any party unless fifty percent of the gross proceeds received by us in connection with such issuance are simultaneously used to make a payment under the promissory notes. The lenders also have the right to seek and receive injunctive relief from a court or arbitrator to prevent the consummation of any fundamental transaction, as defined in the promissory notes, unless it contains a closing condition that the promissory notes are paid in full upon consummation of the transaction or the lenders have provided their written consent to such transaction.

Previous wording

We entered into a patent and know-how licensing agreement with BDD Pharma Limited in August 2018. See “Item 1. Business – Material Agreements” section of our Form 10-K for a description of this agreement. We are required to pay BDD Pharma certain amounts in connection with clinical trial and regulatory milestones. The first milestone payment of $250,000 was paid in February 2023 upon dosing of the first patient in the Phase 3 adult onset and duration study for CTx-1301. Additional payments will become due upon completion of certain milestones as defined in the agreement. The next milestone payment of $250,000 is due upon submission of the NDA.

Current wording

We entered into a patent and know-how licensing agreement with BDD Pharma Limited in August 2018. See “Item 1. Business – Material Agreements” section of our Form 10-K for a description of this agreement. We are required to pay BDD Pharma certain amounts in connection with clinical trial and regulatory milestones. The first milestone payment of $250,000 was paid in February 2023 upon dosing of the first patient in the Phase 3 adult onset and duration study for CTx-1301. The second milestone payment of $250,000 was paid in September 2025 upon submission of the NDA. The third milestone payment of $250,000 will become due upon FDA approval of CTx-1301. Additional royalty payments will become due upon potential sales of CTx-1301 pursuant to the terms of the agreement.

Previous wording

We entered into agreements with Societal, our CMO, for both the manufacturing of pre-process validation batches of our lead asset, CTx-1301 and active pharmaceutical ingredients and materials to be used in process validation batches with a total estimated cost of approximately $2.4 million.

Current wording

We entered into agreements with Societal, our CMO, for both the manufacturing of process validation batches of our lead asset, CTx-1301, including active pharmaceutical ingredients and materials. with a total estimated cost of approximately $7.0 million.

Previous wording

In May 2025, the Company executed a lease to renew the office space for its headquarters in Kansas City, Kansas. The lease has a five-year term that commenced on June 1, 2025 with total rent of $33,145 per month over the lease term. The operating lease right-of-use asset was $1,447,220, the current portion of the operating lease liability was $223,633 and the long-term portion of the lease liability was $1,223,587 as of June 30, 2025.

Current wording

In May 2025, the Company executed a lease to renew the office space for its headquarters in Kansas City, Kansas. The lease has a five-year term that commenced on June 1, 2025 with total rent of $33,145 per month over the lease term. The operating lease right-of-use asset was $1,394,044, the current portion of the operating lease liability was $231,123 and the long-term portion of the lease liability was $1,162,921 as of September 30, 2025.

Previous wording

Since inception we have been engaged in organizational activities, including raising capital and research and development activities. We have not generated revenues and have not yet achieved profitable operations, nor have we ever generated positive cash flow from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. We are subject to those risks associated with any pre-clinical stage pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that our research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, we operate in an environment of rapid technological change that is largely dependent on the services of our employees and consultants. Further, our future operations are dependent on the success of our efforts to raise additional capital. These uncertainties raise substantial doubt about our ability to continue as a going concern for one year after the issuance date of our financial statements. The accompanying consolidated financial statements have been prepared on a going concern basis. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the company to continue as a going concern, which contemplates the continuation of operations, realization of assets and liquidation of liabilities in the ordinary course of business. We have incurred a net loss for the three months ended June 30, 2025 and 2024 and had accumulated losses of $117.1 million since inception to June 30, 2025. We anticipate incurring additional losses until such time, if ever, that we can generate significant revenue from our product candidates currently in development. Our sources of capital have included private capital raises in various classes of units of CTx prior to the Reorganization Merger, the issuance of equity securities in connection with our initial public offering (IPO), follow-on public offerings in September 2023 and February 2024, sales of common stock under our ATM Agreement, Original LP Purchase Agreement and 2025 LP Purchase Agreement, a private placement with WFIA, the WFIA Note, which was subsequently converted to equity, the June 2024 warrant inducement and the issuance of the promissory note in December 2024. Additional capital will be needed by us to fund our operations, to complete development of and to commercially develop our product candidates. There is no assurance that such capital will be available when needed or on acceptable terms.

Current wording

Since inception we have been engaged in organizational activities, including raising capital and research and development activities. We have not generated revenues and have not yet achieved profitable operations, nor have we ever generated positive cash flow from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. We are subject to those risks associated with any pre-clinical stage pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that our research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, we operate in an environment of rapid technological change that is largely dependent on the services of our employees and consultants. Further, our future operations are dependent on the success of our efforts to raise additional capital. These uncertainties raise substantial doubt about our ability to continue as a going concern for one year after the issuance date of our financial statements. The accompanying consolidated financial statements have been prepared on a going concern basis. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the company to continue as a going concern, which contemplates the continuation of operations, realization of assets and liquidation of liabilities in the ordinary course of business. We have incurred a net loss for the three months ended September 30, 2025 and 2024 and had accumulated losses of $126.1 million since inception to September 30, 2025. We anticipate incurring additional losses until such time, if ever, that we can generate significant revenue from our product candidates currently in development. Our sources of capital have included private capital raises in various classes of units of CTx prior to the Reorganization Merger, the issuance of equity securities in connection with our initial public offering (IPO), follow-on public offerings in September 2023 and February 2024, sales of common stock under our ATM Agreement, Original LP Purchase Agreement and 2025 LP Purchase Agreement, a private placement with WFIA, the WFIA Note, which was subsequently converted to equity, the June 2024 warrant inducement and the issuance of the promissory note in December 2024. Additional capital will be needed by us to fund our operations, to complete development of and to commercially develop our product candidates. There is no assurance that such capital will be available when needed or on acceptable terms.