CING 10-K & 10-Q changes, risk factors and insider trading

Our future operating results could differ materially from the results described in this annual report due to the risks and uncertainties described below. You should consider carefully the following information about risks in evaluating our business. If any of the following risks actually occur, our business, financial condition, results of operations and future growth prospects would likely be materially and adversely affected. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations and, in these circumstances, the market price of our securities would likely decline. In addition, we cannot assure assure investors that our assumptions and expectations will prove to be correct. Important factors could cause our actual results to differ differ materially from those indicated or implied by forward-looking statements. See “Cautionary Note Regarding Forward Looking Statements” for a discussion of some of the forward-looking statements that are qualified by these risk factors. Factors that could cause or contribute to such differences include those factors discussed below.

We have never generated revenue from operations and are currently operating at a loss and expect our operating costs will increase significantly as we incur costs related to formulation/manufacturing development, the clinical trials for our drug candidates and operating as a public company.company and, if we are successful in obtaining regulatory approval to market one or more of our product candidates, the marketing and commercialization of such approved product(s). We expect to incur expenses without corresponding revenues unless and until we are able to obtain regulatory approval and successfully commercialize our product candidates, CTx-1301, CTx-1302 and CTx-2103.CTx-1301. We may never be able to obtain regulatory approval for the marketing of our drug candidates in any indication in the United States or internationally. Even if we obtain regulatory approval for CTx-1301, CTx-1302 and/or CTx-2103, development expenses will continue to increase for any future assets. As we arecontinue performingto thedevelop dataCTx-1301, consolidationseek marketing approval and andconduct analyticalpre-commercialization activities for CTx-1301 Phase 3 clinical trials in pursuit of FDA approval,activities, we will continue to incur substantial costs.

We will continue to expend substantial cash resources for the foreseeable future for the clinical development of our product candidates and development of any other indications and product candidates we may choose to pursue.pursue, and, if we are successful in obtaining regulatory approval to market one or more of our product candidates, the marketing and commercialization of such approved product(s). These expenditures will include costs associated with manufacturing and clinical development, such as conducting clinical trials, manufacturing operations and product candidate supply, as well as marketing and selling any products approved for sale. Because the conduct and results of any clinical trial are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our current and any future product candidates. If one or more of our product candidates are approved by the FDA, these expenditures will also include [__].

We will need to raise significant additional capital to continue operations and continue to support our planned development and commercialization activities. We believe that our cash on hand will satisfy our capital needs late into the fourth quarter of 20252026 under our current business plan. We have based these estimates, however, on assumptions that may prove to be wrong, and we could spend our available capital resources much much faster than we currently expect or require more capital to fund our operations than we currently expect. The amount and timing of our our future funding requirements will depend on many factors, including:

In DecemberNovember 2024,2025, we issued the Note to Lender. Pursuant to the Note Purchase Agreement, while the Note is outstanding, we will not enter into any arrangement that prohibits us from entering into a variable rate transaction untilwith JulyLender 1,or 2025,its affiliates, or from issuing our securities to Lender or its affiliates. We are also prohibited from entering into a variable rate transaction while the Note is outstanding, subject to certain exceptions. Also, while the Note is outstanding, upon any issuance by us of any debt security with any economic term or condition more favorable to the holder of such security that was not provided to Lender pursuant to the Note, then, at Lender’s option, such additional term shall become part of the Note. The Note also provides that following an event of default under the 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 Note. Additionally, Lender 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 Note, unless it contains a closing condition that the Note is paid in full upon consummation of the transaction or Lenderlender has provided its written consent to such transaction.

If we are unable to raise additional capital when required or on acceptable terms or if we are unable to enter into strategic collaborations for CTx-1301,our CTx-1302,product and/or CTx-2103,candidates, we may be required to further restrict our operations or obtain funds by entering into agreements on unattractive terms, which would likely have a material adverse effect on our business, stock price and our relationships with third parties with whom we have business relationships, at least until additional funding is obtained. If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that would likely result in our securityholders losing some or all of their investment in us. In addition, our ability to achieve profitability or to respond to competitive pressures would be significantly limited.

In addition, if we are unable to secure sufficient capital to fund our operations, we may have to enter into strategic collaborations that could require us to share commercial rights to CTx-1301,our CTx-1302,product and/or CTx-2103candidates with third parties in ways that we currently do not intend or on terms that may not be favorable to us or our securityholders.

The Notenote Purchasepurchase Agreementagreement and Notenote issued by us in DecemberNovember 20242025 contain restrictive covenants and adjustments in the event we default on the Note that may limit our operating flexibility and impact our operations.

OnIn DecemberNovember 20, 2024,2025, we entered into a Note Purchase Agreement with StreetervilleAvondale Capital, LLC, or Lender, pursuant to which we issued and sold to Lender an unsecured promissory note, or Note, in the amount of $5,480,000.$6,570,000. The Note bears interest at a rate of 9% per annum and matures 18 months after its issuance date.

Pursuant to the Note Purchase Agreement, we are subject to certain restrictions on our ability to issue securities during the term of the Note. Specifically, we have agreed, among other things, to obtain Lender’s consent prior to issuing any debt securities or certain equity securities where the pricing of such equity securities is tied to the public trading price of our common stock and 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 are unable to obtain Lender’s consent prior to issuing anysuch debt or certain equity securities, such issuance may be a breach of the Note Purchase Agreement, and 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.

In addition, from time to time, beginning on JulyMay 2,7, 2025,2026, Lender may redeem a portion of the Note, not to exceed an amount of $550,000$660,000 per permonth; month.provided, that, prior to our receipt of a “complete response letter” from the FDA, we may defer up to two redemptions for up to thirty (30) days each. If we exercise our deferral right, the outstanding balance of the Note will be increased by 1% of the outstanding balance on the date of the deferral. We were able to satisfy redemptions for the note we issued in December 2024 by exchanging shares of our common stock. Our failure to pay such redemptions,redemptions with cash or in exchange for shares of our common stock, when due, may result in defaults under our agreements with the Lender. If we are in default with respect to our obligations under the Note, the Lender may consider the Note immediately due and payable and may elect to substantially increase the interest rate of the Note. We may not have the required funds to pay the required note redemptions and such redemptions, or penalties in connection therewith, may have an adverse effect on our cash flows, results of operations, and ability to pay our other debts as they come due.

Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations.limitations .

We are dependent primarily on the successful development and commercialization of our product candidates, CTx-1301 and CTx-1302 for the treatment of ADHD and CTx-2103 for the treatment of anxiety, which are either in product/early clinical development (CTx-2103), clinicallate development (CTx-1301) or planned for future product development (CTx-1302) and are not yet approved. We cannot give any assurance that we will receive regulatory approval for such product candidates or any other product candidates, which is necessary before they can be commercialized.

We have not completed development of and/or obtained regulatory approval for any of our product candidates. Development will requirerequires the commitment commitment of substantial financial resources, extensive product candidate development, and clinical trials. This process takes years of effort without any assurance of ultimate success.

If we are unable to achieve one or more of the above factors, many of which are beyond our control, in a timely manner or at all, we could experience significant delays and increased costs or an inability to obtain regulatory approvals or commercialize our product candidates. Even if regulatory approvals are obtained, we may never be able to successfully commercialize any of our product candidates. Accordingly, we cannot assure you that we will be able to generate sufficient revenue through the sale of our product candidates or any future product candidates to continue operations. See “The commercial success of our product candidates, if approved, depends partially upon attaining market acceptance by physicians, patients, third-party payors, and the medical community” below for more information Our product development efforts with respect to our product candidates may fail for many reasons, including but not limited to:

We are not permitted to market our drug product candidates in the United States until we receive the respective approval of a NDA from the the FDA. The time required to obtain approval, if any, by the FDA is unpredictable, but typically takes multiple years following the commencement commencement of clinical trials, and depends upon numerous factors, including the substantial discretion of the regulatory authorities and the type, complexity and novelty of the product candidates involved. We have not submitted a marketingNDA applicationfor such as an NDACTx-1301 to the FDA orin anyJuly similar2025. applicationOn October 9, 2025, the NDA submission was accepted by the FDA and a PDUFA target action date of May 31, 2026 was assigned. To date, the FDA has made several information requests, primarily related to anyCMC, otheras regulatoryit authorityreviews inour anyPrecision Timed jurisdiction.Release™ Platform, the first tri-modal, pulsatile capable tablet delivery system. We have been engaged with and responded to all information requests from the FDA received to date. In February 2026, the FDA conducted a pre-approval inspection of our CDMO facility used to manufacture CTx-1301. This facility was issued a Form 483 by the FDA at the conclusion of the inspection with three observations. Two observations were related to the facility, and one observation was specific to CTx-1301. Our CDMO is working on responses to these observations, with our input where relevant.

Our development costs may also increase if we experience delays in testing, clinical trials, manufacturing or obtaining marketing approvals. For example, our development costs increased for CTx-1301 due to rescheduling of the Phase 3 fixed-dose study as a result of manufacturing delays prior to October 2022 for the final dosage strengths needed for that study. We do not know whether any of our clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. In late 2023, we announced a change in the clinical development plan for CTx-1301 based on feedback from the FDA, and accordingly stopped enrollment in two Phase 3 trials of CTx-1301 and are performing the data consolidation and analytical activities for these trials in pursuit of NDA submission expected in mid-2025. We may need to restart these trials and/or start new trials in order to win regulatory approval of CTx-1301. We may find it difficult or impossible to restart or start such clinical trials.CTx-1301 Significant product manufacturing or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidates.

Pediatric drug development may require additional studies to determine safe dosing and long-term safety. These additional studies may require investment of significant additional resources beyond those required for regulatory approval of the drugs in adults. Although, we have stopped enrollment in the pivotal Phase 3 fixed-dose pediatric and adolescent safety and efficacy study of CTx-1301 and the Phase 3 pediatric dose-optimization onset and duration study of CTx-1301 andbased areon performingfeedback from the data consolidation and analytical activities for these trials in pursuit of NDA submission expected in mid-2025,FDA, we may have to restart and complete these and other trials in order to obtain regulatory approval. Approval of CTx-1301 and CTx-1302 may be delayed due to these additional requirements and this may have an adverse effect on the commercial prospects of CTx-1301 and CTx-1302,CTx-1301, as well as delay our ability to generate product revenue, possibly materially. InWe addition, as a result ofcannot COVID-19 (or other potential pandemics), there may be a smaller pool of children from which we can enroll for our clinical trials. We cannot guarantee that we will receive regulatory approval to commercialize our product candidates in the pediatric populations or the adult adultpopulation. population.See “—We depend heavily on the success of CTx-1301. If we are unable to secure approval of CTx-1301, we will never be able to generate revenues from CTx-1301, and our ability to create stockholder value will be severely limited” above for more information about the risks related to FDA approval of CTx-1301.

Section 505(b)(2) of the FDCA permits the filing of an NDA where at least some of the information required for approval comes from investigations that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. The FDA interprets Section 505(b)(2) of the FDCA, for the purposes of approving an NDA, to permit the applicant to rely, in part, upon published literature or the FDA’s previous findings of safety and efficacy for an approved product. The FDA may also require the applicant to perform additional clinical trials or measurements to support any deviation from the previously approved product. The FDA may then approve the new product candidate for all or some of the label indications for which the referenced product has been approved, as well as for any new indication sought by the Section 505(b)(2) applicant. The FDA may require an applicant’s product label to have all or some of the limitations, contraindications, warnings or precautions included in the reference product’s label, including a black box warning, or may require the label to have additional limitations, contraindications, warnings or precautions. A key element of our strategy is to seek FDA approval for our current product candidates, CTx-1301, CTx-1302, and CTx-2103, through the 505(b)(2) NDA pathway. Based on guidance received from the FDA, we submitted the NDA for CTx-1301 in July 2025 under the Section 505(b)(2) pathway with Focalin® XR as the reference listed drug, using its efficacy and safety data on file with the FDA as a basis for approval, together with bioavailability/bioequivalence data and efficacy/safety data from our CTx-1301 clinical program. If the FDA determines that our product candidates do not meet the requirements of Section 505(b)(2), or if we cannot demonstrate bioequivalence or comparable bioavailability of our product candidates to approved products, we may need to conduct additional clinical trials, provide additional data and information, and meet additional standards for regulatory approval applicable to a traditional NDA submitted pursuant to Section 505(b)(1). Moreover, even if the FDA does allow us to pursue the 505(b)(2) NDA pathway, depending on the product candidate, we may still need to conduct additional clinical trials, including clinical trials to assess product safety or efficacy. If this were to occur, the time and financial resources required to obtain FDA approval for our product candidates, and complications and risks associated with our product candidates, would likely substantially increase.

We may be unable to successfully complete our Phase 3 clinical trials for CTx-1301 or any future clinical trials for any otherour product candidates.

The conduct of a Phase 3 clinical trial is a complicated process. Although members of our management team have conducted Phase 3 clinical trials in the past while employed at other companies, we as a company havehad not conducted a Phase 3 clinical trial before,prior andto asthe aclinical trials result mayfor require more time and incur greater costs than we anticipate.CTx-1301. Failure to include the correct treatment regimen, complete, or delays in, our Phase 3 clinical trials, could prevent us from or delay us in commencing future clinical trials for CTx-1301,trials, obtaining regulatory approval of and commercializing our product candidates, which would adversely impact our financial performance. In addition, some of our competitors are currently conducting clinical trials for product candidates that treat the same indications as CTx-1301, and patients who are otherwise eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates.

In May 2024, we announced a change in the clinical development plan for CTx-1301 based on feedback from FDA, and accordingly stopped enrollment in two Phase 3 trials of CTx-1301 and are performing data consolidation and analytical activities in pursuit of NDA submission.CTx-1301. We may need to restart these trials and/or start new trials in order to win regulatory approval of CTx-1301. We may find it difficult or impossible to restart or start such clinical trials.

Even if we obtain regulatory approval for CTx-1301,our CTx-1302,product and/or CTx-2103,candidates, such approval may be limited, and we will be subject to stringent, ongoing ongoing government regulation .regulation.

Even if regulatory authorities approve CTx-1301,our CTx-1302,product and/or CTx-2103candidates for commercialization, the FDA could approve less than the full scope of indications or labeling claims that we seek or may otherwise require special warnings or other restrictions on their use or marketing. Regulatory authorities may limit the segments of the target population to which we or others may market CTx-1301, CTx-1302, and/or CTx-2103 or limit the target population for our other product candidates. The advantages of our CTx-1301,product CTx-1302,candidates and/or CTx-2103 may not be agreed to by the FDA or other regulatory authorities or such authorities may otherwise object to the inclusion of related claims in product labeling or advertising and, as a result CTx-1301,our CTx-1302,product and/or CTx-2103candidates may not have our expected competitive advantages when compared to other similar products. In particular, the FDA may limit labeling claims based upon the duration of efficacy of our products. In addition, any new legislation addressing drug safety issues could result in delays in product development or commercialization, or increased costs to assure compliance.

If we obtain regulatory approval for any of our product candidates, activities such as the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and record keeping for the products will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs. The FDA or comparable regulatory authorities may also impose requirements for costly post-marketing nonclinical studies or clinical trials (often called “Phase 4 trials”) and post-marketing surveillance to monitor the safety or efficacy of the product. If we or a regulatory authority discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, production problems or issues with the facility where the product is manufactured or processed, such as product contamination or significant not-compliance with applicable cGMPs, a regulator may impose restrictions on that product, the manufacturing facility or us. Accordingly, we and our CMOsCDMOs will be subject to continual review and inspections to to assess compliance with cGMP and adherence to commitments made in any NDA submission to the FDA or any other type of domestic or foreign marketing application. If we or our third-party providers, including our CMOsCDMOs fail to comply fully with applicable regulations, then we may be required to initiate a recall or withdrawal of our products.

Our employees, independent contractors, principal investigators, consultants, vendors, CROs, CMOsCDMOs and any partners with which we may collaborate may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk that our employees, independent contractors, principal investigators, consultants, vendors, CROs, CMOs,CDMOs, and any any partners with which we may collaborate may engage in fraudulent or other illegal activity. Misconduct by these persons could include intentional, reckless or negligent conduct or unauthorized activity that violates laws or regulations, including those laws requiring the reporting of true, complete and accurate information to the FDA or other regulatory authorities; manufacturing standards; federal, state and foreign healthcare fraud and abuse laws; data privacy laws and regulations; or laws that require the true, complete and accurate reporting of financial information or data. In particular, sales, marketing and other business arrangements in the healthcare industry are subject to extensive laws intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws may restrict or prohibit a wide range of business activities, including research, manufacturing, distribution, pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws also involve the improper use or misrepresentation of information obtained in the course of clinical trials, or illegal misappropriation of drug product, which could result in regulatory sanctions or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations, and serious harm to our reputation. In addition, federal procurement laws impose substantial penalties for misconduct in connection with government contracts and require certain contractors to maintain a code of business ethics and conduct. Additionally, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a material and adverse impact on our business, financial condition, results of operations and prospects including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement, imprisonment, loss of eligibility to obtain marketing approvals from the FDA, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements if subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with any of these laws, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our operating results.

A pandemic, epidemic, or outbreak of an infectious disease, such as COVID-19,disease could cause a disruption to the development of our product candidates.

Public health crises such as pandemics or similar outbreaks could adversely impact our business. The COVID-19extent pandemic led to the implementation of various responses, including government-imposed quarantines, travel restrictions and other public health safety measures. The extent to which a pandemic, epidemic or outbreak of an infectious disease impacts our operations or those of our third-party partners, including our development studies or clinical trial operations, will depend on future occurrences, which are highly uncertain and cannot be predicted with confidence, including the duration of any outbreak and the actions to contain or treat its impact, among others. Although the majority of our operations are conducted in the United States, the spread of an infectious disease globally could adversely impact our product candidate development or clinical trial operations in the United States and abroad. Any negative impact infectious diseases have on patient enrollment or treatment or the execution of our product candidates could cause costly delays to clinical trial activities, which could adversely affect our ability to obtain regulatory approval for and to commercialize our product candidates, increase our operating expenses, and have a material adverse effect on our financial results.

We expect to have competitors both in the United States and internationally, including major multinational pharmaceutical companies. For example, amphetamine XR (mixed-amphetamine salts) is currently marketed in the United States by Shire under the brand name Adderall XR, and methylphenidate is marketed in the United States by Janssen under the brand name Concerta, and by Novartis under the brand names Focalin XR and Ritalin LA. Further, makers of branded drugs could also enhance their own formulations in a manner that competes with our enhancements of these drugs. Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development staff and more experienced marketing and manufacturing organizations. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors. As a result, these companies may obtain regulatory approval more rapidly than we are able and may be more effective in selling and marketing their products as well. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis drug products or drug delivery technologies that are more effective or less costly than our PTR platform, or any product candidate that we are currently developing or that we may develop. In addition, our competitors may file citizens petitions with the FDA in an attempt to persuade the FDA that our products, or clinical trials that support their approval, contain deficiencies or that new regulatory requirements be placed on the product candidate or drug class of the product candidate. Such actions by our competitors could delay or even prevent the FDA from approving any NDA that we submit under Section 505(b)(2).

Additionally, current and future efforts by Congress, state legislatures, the FDAFDA, DEA and other regulatory bodies to combat abuse of opioids and stimulants may negatively impact the market for our product candidates. It is possible that lawmakers or the FDA will announce new legislation or regulatory initiatives at any time that may increase the regulatory burden or decrease the commercial opportunity for our product candidates.

We are a biopharmaceutical company using our proprietary 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. WeWith arean initiallyinitial focusing our effortsfocus on the treatment of ADHD.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 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.

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,capital and establishing our intellectual property portfolio and conducting clinical trials.portfolio. 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 107.3$128.7 million as of December 31, 2024.2025.

We expect to continue to incur significant expenses and increasing operating losses in the near term. We expect our expenses will increase substantially in connection with our ongoing activities,term as we:

We are targeting to file our NDA submission for CTx-1301 in mid-2025 and believe our cash will satisfy our capital needs late into the fourth quarter of 20252026 under our current business plan.plan, which primarily includes activities related to us seeking regulatory approval for CTx-1301 and pre-commercialization efforts for CTx-1301. We will also need additional capital to advance our other programs and commercialization efforts for CTx-1301.programs. See “Liquidity and Capital Resources” below.

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. Our most advanced product candidate currently is CTx-1301, for which we submitted a NDA with the FDA in July 2025. On [DATE], the NDA submission was accepted by the FDA and a PDUFA target action date of May 31, 2026 was assigned. However, completing the process of obtaining FDA approval of the pending NDA for CTx-1301 still involves substantial risk. See “Risk Factors—We depend heavily on the success of CTx-1301. If we are unable to secure approval of CTx-1301, we will never be able to generate revenues from CTx-1301, and our ability to create stockholder value will be severely limited” for more information about the risks related to regulatory approval of CTx-1301.

We entered into the At the Market Offering Agreement (“ATM Agreement”) with HCW, as sales agent, in January 2023 as amended in May 2023, pursuant to which we maycould offer and sell, from time to time through HCW, shares of our common stock for aggregate proceeds of up to $23.5$32.34 million (upon the terms and subject to to the conditions and limitations set forth in the ATM Agreement). On March 16, 2026, we terminated the ATM Agreement, effective March 23, 2026.

In April 2023, we entered into a purchase agreement (the “LincolnOriginal ParkLP Purchase Agreement”) with Lincoln Park Capital Fund LLC (“Lincoln Park”). Pursuant to the LincolnOriginal ParkLP Purchase Agreement, Lincoln Park has 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 Lincoln Park Agreement) from time to time and at our sole discretion over the 36-month term of the Lincoln Park Agreement.stock. During 2024,2025, we sold 1,472,363897,415 shares of common stock under the LincolnOriginal ParkLP Purchase Agreement, for net proceeds of $8,037,501.$3,513,236. SubsequentAs toof DecemberJune 31,30, 2024,2025, we sold 223,409 shares of common stock under theto Lincoln Park Agreement,the formaximum netdollar proceedsvalue worth of $899,989.common stock pursuant to the Original LP Purchase Agreement, and the Original LP Purchase Agreement thereupon expired in accordance with its terms.

The WFIA Note was unsecured with interest accruing at 15% per annum. Outstanding principal and all accrued and unpaid interest was due and payable on August 8, 2025 unless accelerated due to an event of default. After the conversion of the remaining principal amount plus all accrued interest thereon and the issuance of the January WFIA Pre-Funded Warrants, the WFIA Note was paid in full and thewe Company hashave no further obligations under the WFIA Note. WFIA exercised all of its pre-funded warrants in April 2024.

On February 2, 2024, we entered into agreements, including a Securities Purchase Agreement, with investors, pursuant to which we issued 114,583 shares of our common stock, pre-funded warrants to purchase up to an aggregate of 197,917 shares of our common stock, Series A warrants to purchase up to 312,500 shares of our common stock and Series B warrants to purchase up to 312,500 shares of our common stock (the “February 2024 Offering”). The February 2024 Offering closed on February 6, 2024. The combined purchase price per share of common stock and accompanying Series A and Series B warrants was $24.00. The combined purchase price per pre-funded warrant and accompanying Series A and Series B warrants was $23.9988, which represents the public offering price per share of common stock and accompanying warrants less the $0.0012 per share exercise price for each pre-funded warrant. The pre-funded warrants are exercisable at any time after the date of issuance and have no expiration date. The holder of pre-funded warrants may not exercise the warrants if the holder, together with its affiliates, would beneficially own more than 4.99% (or, at the election of the holder, 9.99%) of the number of shares of common stock outstanding immediately after giving effect to such exercise. The Series A warrants have an exercise price of $24.00 per share, were exercisable immediately, and will expire five years after the issuance date, and the Series B warrants have an exercise price of $24.00 per share, were exercisable immediately, and will expire two years after the issuance date. We received gross proceeds of approximately $7.5 million, before deducting $750,950 of placement agent’s fees and other offering expenses, pursuant to the February 2024 Offering. As of December 31, 2024, allAll pre-funded warrants hadwere beenexercised exercised.during 2024.

On December 20, 2024, we entered into a Note Purchase Agreement (the “2024 Note Purchase Agreement”) with Streeterville Capital, LLC, a Utah limited liability company (“Lender”), pursuant to which we issued and sold to Lender an unsecured promissory note (the “Promissory Note”) in the amount of $5,480,000.$5,480,000 (the “2024 Note”). The principal amount includesincluded an original issue discount of $450,000 and expenses payable by us of $30,000. In exchange for the Promissory2024 Note, the Lender paid a purchase price of $5,000,000 in cash. The Promissory 2024 Note bears bore interest at a rate of 9% per annum and matureshad a maturity 18 months after its issuance date. Our wholly-owned subsidiaries Cingulate Cingulate Therapeutics LLC and Cingulate Works, Inc., provided a guarantee of our obligations to the Lender under the Promissory2024 Note and the other transaction documents. We intend to useused the net proceeds from the sale of the Promissory2024 Note for working capital and other general corporate purposes.

From time to time, beginning on July 2, 2025, Lender maycould redeem a portion of the Promissory2024 Note. Pursuant to the terms of the 2024 Note, notwe were charged a monitoring fee equal to exceed an amount of $550,000 per month. In the eventoutstanding the Promissory Note is outstandingbalance on the 90-day anniversary of the effective date of the Promissory2024 Note, we will be charged a monitoring fee equal to the outstanding balance on such dateNote divided by 0.85 less the outstanding balance on such date. Subject to the terms and conditions set forth in the Promissory Note, we may prepay all or any portion of the outstanding balance of the Promissory Note at any time.

Pursuant to the 2025 Note Purchase Agreement, while the Promissory2025 Note is still outstanding, we will not enter into any arrangement that prohibits us from entering into a variable rate transaction, as defined in the 2025 Note Purchase Agreement, with LenderAvondale or its affiliates, or from from issuing our securities to LenderAvondale or its affiliates. We are also prohibited from entering into a variable rate transaction untilwhile the July 1,2025 2025,Note is outstanding, subject to certain exceptions. At any time while the Promissory2025 Note is still outstanding, LenderAvondale will have the right, but not the obligation, with our consent, to reinvest up to an additional $5.0 million in one or more tranches on the same terms and conditions as the Promissory2025 Note. Additionally, so long as the Promissory2025 Note is outstanding, upon any issuance by us of any debt security with with any economic term or condition more favorable to the holder of such security that was not provided to LenderAvondale pursuant to the Promissory2025 Note, then, at Lender’sAvondale’s option, such additional term shall become part of the Promissory2025 Note and related documents for the benefit of Lender.Avondale. See Note 8 to our consolidated financial statements for additional information regarding the Promissory2025 Note and the2025 Note Purchase Purchase Agreement.

Research and development activities are central to our business model. WeSubject to successful regulatory approval and commercialization of CTx-1301, 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.

General and administrative expenses consist primarily of (i) professional fees for legal, accounting, audit, tax and consulting services, (ii) salaries and related costs for our employees in administrative, executive and finance functions and (iii) pre-commercialization expenses functions.for CTx-1301. General and administrative expenses also include professional fees for legal, accounting, audit, tax and consulting services, insurance, office, and travel expenses.

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 operationsoperations, including the potential commercialization of ourCTx-1301, productand candidates.incur costs related to pre-commercialization activities. 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.

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

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.

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

The following table summarizes issuance cost and change in fair value of derivative and interest and other income (expense), net for the years ended December 31, 20242025 and 20232024:

Net cash used in operating activities was $18.5$17.2 million for the year ended December 31, 2024.2025. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidatesCTx-1301 resulting in a net loss of $15.5$22.4 million, prior to the effects of two significant noncash items, including stock-based compensation expense of $1.0$1.5 millionmillion, issuance cost and change in fair value of derivative of $1.2 million, loss on debt extinguishment of $0.8 million, depreciation expense of $0.7$0.5 million and accretion of discount on note payable of $0.3 million. Changes in operating assets and liabilities included aan decreaseincrease in trade accounts payable and accrued expenses of $4.5 $1.5 million primarily due to increases in accrued commercial costs and accrued interest on the paymentoutstanding ofnote vendorpayable. balancesThese are partially offset by an increase in theprepaid firstexpenses quarterand ofother 2024current withassets the cash proceeds from the issuance of common stock pursuantdue to our ATMpayments Agreementfor inmanufacturing January 2024 and the issuance of equity in the February 2024 Offering.materials.

Net cash used in operating activities was $15.0$18.5 million for the year ended December 31, 2023.2024. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidatesCTx-1301 resulting in a net loss of $23.5$16.6 million, prior to the effects of two significant noncash items,items including stock-based compensation expense of $0.8$1.0 million, issuance cost and change in fair value of derivative of $1.0 million and depreciation expense of $0.6$0.7 million. Changes in operating assets and liabilities included a decrease in prepaid expenses and other current assets of $1.8 million due to the recognition of expense relating to upfront deposits on clinical and manufacturing activity made at the start of the Phase 3 trials which were in process at December 31, 2023. In addition, there was an increase in trade accounts payable and accrued expenses of $5.2$4.5 million due to cash constraints and amountsprimarily due to vendorsthe primarilypayment relatingof vendor balances in the first quarter of 2024 with the cash proceeds from the issuance of common stock pursuant to clinicalour developmentATM activity.Agreement in January 2024 and the issuance of equity in the February 2024 Offering.

Net cash provided by financing activities in the year ended December 31, 20242025 was related to the cash proceeds from the issuance of common stock pursuant to the ATM Agreement, Lincolnthe ParkOriginal LP Purchase Agreement, the February2025 2024LP OfferingPurchase and the June 2024 Warrant Inducement,Agreement, as well as the issuance of the Promissory 2025 Note in DecemberNovember 2024.2025.

Net cash provided by financing activities in the year ended December 31, 20232024 was related to the cash proceeds from the issuance of 47,073common stock sharespursuant of common stock in connection with various equity transactions, including the September 2023 Offering, WFIA Private Placement and usage ofto the ATM Agreement andAgreement, LincolnOriginal ParkLP Purchase Agreement, the February 2024 Offering and the June 2024 Warrant Inducement, as well as the increase in the principal balanceissuance of the WFIA2024 Note in MayDecember 2023.2024.

In DecemberNovember 2024,2025, we received net proceeds of $5,000,000$6,000,000 from the issuance of the Promissory2025 Note with Avondale pursuant to the 2025 Note Purchase Agreement.

During 2024, 2025, we sold 983,093785,784 shares of common stock under the ATM Agreement, for net proceeds of $3,574,574, after deducting $122,576 of compensation to HCW and other administration fees. Subsequent to December 31, 2025, we sold 210,158 shares of common stock under the ATM Agreement, for net proceeds of $9,393,550,$1,304,011, after deducting $298,498$43,300 of compensation to HCW and other administration fees. SubsequentOn toMarch December16, 31, 2024,2026, we sold 142,685 shares of common stock underterminated the ATM Agreement, for net proceeds of $776,091, after deducting $25,756 of compensation to HCW and other administration fees. As ofeffective March 27,23, 2025,2026. theWe anticipate that aggregatewe will enter into another at-the-market offering priceagreement ofwith sharesa ofdifferent commoncounterparty stock available for issuance underin the ATMnear Agreement was approximately $7.4 million.future.

During 2024,2025, we sold 1,472,363852,948 shares of common stock under the Lincoln2025 ParkLP AgreementPurchase Agreement, for net proceeds of $8,037,501.$3,238,007. Subsequent to December 31, 2024,2025, we sold 223,4091,526,628 shares of common stock under the Lincoln2025 ParkLP Purchase Agreement, for net proceeds of 899,989.$8,506,791. As of March 27,18, 2025,2026, thewe aggregatehad offeringapproximately price$13.3 million of shares of common stock available for issuanceavailability under the Lincoln2025 ParkLP AgreementPurchase was approximately $2.6 million.Agreement.

As of December 31, 2024,2025, we had cash and cash equivalents of $12.2$11.0 million. WeTaking into account the $12.0 million we received in the Private Placement, we believe our cash will satisfy our capital needs late into the fourth quarter of 20252026 under our current business plan. WeChanging circumstances are targeting to file our NDA submission for CTx-1301 in mid-2025. We will need additional capital to advance our commercialization efforts for CTx-1301 as well as our other programs. 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 interest rate environment.

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,for subjectCTx-1301 toand conduct obtainingpre-commercialization such approval, the eventual commercialization of our product candidates.activities. If we obtain marketing approval for our product candidates,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.

To continue to grow our business over the longer term, we plan to commit substantial resources to research and development, including clinical trials of our product candidates, and other operations and potential product acquisitions and in-licensing. We have evaluated and expect to continue to evaluate a wide array of strategic transactions as part of our plan to acquire or in-license and develop additional products and product candidates to augment our internal development pipeline. Strategic transaction opportunities that we may pursue could materially affect our liquidity and capital resources and may require us to incur additional indebtedness, seek equity capital or both. In addition, we may pursue development, acquisition or in-licensing of approved or development products in new or existing therapeutic areas or continue the expansion of our existing operations. Accordingly, we expect to continue to opportunistically seek access to additional capital to license or acquire additional products, product candidates or companies to expand our operations, or for general corporate purposes. Strategic transactions may require us to raise additional capital through one or more public or private debt or equity financings or could be structured as a collaboration or partnering arrangement. We are actively seeking a strategic pharmaceutical partnership under which we would license CTx-1301 in the United States, internationally, or both. In March 2023, we entered into the Commercialization Agreement with Indegene. Should we be unable to identify an appropriate pharmaceutical partnership, if we receive FDA approval for CTx-1301, Indegene would provide commercialization services for CTx-1301, including marketing, sales, market access and distribution, on a fee for service basis.

For example, pursuant to the 2025 Note Purchase Agreement,Agreement with Avondale, we are subject to certain restrictions on our ability to issue securities during the term of the 2025 Note. Specifically, we have agreed, among other things, to obtain Lender’s consent prior to issuing any debt securities or certain equity securities where the pricing of such equity securities is tied to the public trading price of our common stock and 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 Lenderthe lenders or any of itstheir affiliates, or from issuing common stock or other equity or debt securities to Lenderthe lenders or any of itstheir affiliates. If we are unable to obtain Lender’s consent prior to issuing any debt or certain equity securities, such issuance may be a breach of the 2025 Note Purchase Agreement, and we may be obligated to indemnify LenderAvondale for loss or damage arising as a result of any breach or alleged breach by us of the 2025 Note Purchase Agreement, which may affect our business operations and financial condition. Additionally, the 2025 Note provides that following an event of default under the 2025 Note, LenderAvondale 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 2025 Note. Avondale Lender also has the right to seek and receive injunctive relief from a court or arbitrator to prevent the consummation of any fundamental transaction, transaction, as defined in the 2025 Note, unless it contains a closing condition that the 2025 Note isare paid in full upon consummation of the transaction or LenderAvondale has provided its written consent to such transaction.

We entered into a patent and know-how licensing agreement with BDD Pharma Limited in August 2018. See “Item 1. Business – Material Agreements” for a description of this agreement. We are required to pay BDD Pharma certain amounts in connection with clinical trial and regulatory milestones. The firstfinal milestone payment of $250,000 becamewill be due into February 2022BDD upon dosingFDA approval of the first patient in the Phase 3 adult onset and duration study for CTx-1301. Additional royalty payments will become due upon completionpotential sales of certainCTx-1301 milestones aspursuant definedto inthe terms of the agreement.

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 years ended December 31, 20242025 and 20232024 and had accumulated losses of $108.5$132.4 million since inception to December 31, 2024.2025. 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,offerings including thein September 2023 Offering and the February 2024 Offering, 2024, sales of common stock under ourthe ATM Agreement, Original LP Purchase Agreement and Lincoln2025 ParkLP Purchase Agreement, a private placement with WFIA, the WFIA Note, which was subsequently converted to equity, the June 2024 Warrantwarrant Inducement andinducement, the issuance of the Promissorypromissory Notenotes in December 2024 and November 2025 and the Private Placement in December 2024.February 2026. Additional financings will be needed by us to fund our operations, to complete development of and to commercially develop CTx-1301 and our other product candidates. There is no assurance that such financing will be available when needed or on acceptable terms.

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 $151.9$160.4 million as of MarchJune 30, 31, 2026.

We have incurred significant losses since our inception. Our net losses were $9.3$5.9 million and $3.9$5.0 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. See “Results of Operations” below for an explanation of the fluctuations in our net losses. As of MarchJune 31,30, 2026, we had an accumulated deficit of $141.7$147.6 million.

As of MarchJune 31,30, 2026, we had cash and cash equivalents of $25.9$28.4 million, which we believe will be sufficient to fund our operations into early mid 2027, including the costs associated with completing the requested CMC work and seeking regulatory approval for CTx-1301 and the build-out of internal and external support for the commercial launch of CTx-1301, if approved. We will need additional capital to advance other potential development programs. See “Liquidity and Capital Resources” below.

In October 2025, we announced that the FDA accepted for review our NDA for CTx-1301 and assigned a Prescription Drug User Fee Act (PDUFA) targeted action date of May 31, 2026. AsOn partJune 1, 2026, we received a Complete Response Letter (CRL) from the FDA regarding the NDA for CTx-1301. The CRL identified specific requests for additional CMC information and did not raise any concerns regarding the clinical safety or efficacy of CTx-1301. We and our CDMO (defined below) are working to complete the CMC work necessary to support a resubmission of the NDA reviewas process,promptly theas FDApracticable. hasThere requestedcan additionalbe CMC-related information.no Theassurance Company is working closely with the FDA to address these requests. Depending onregarding the timing andof scopeany resubmission, that any resubmission will be accepted by the FDA, that approval of theseCTx-1301 requestswill andoccur responses,following any resubmission, or that approval will occur at all. See Risk Factors section in Part II of this report for more information about the FDArisks may require additional timerelated to evaluateregulatory theapproval informationof provided.CTx-1301.

CoreRx, Inc., doing business as Bend Biosciences,Bioscience, a contract development and manufacturing organization (“CDMO”), will manufacture all clinical, registration, and, if approved, commercial batches of our lead ADHD candidate, CTx-1301. Manufacturing will occur at a suite within the CDMO’s Gainesville, GA facility that is outfitted with equipment supplied by us.

IfWe have approved, we plan to commercialize CTx-1301 in the United States through our master servicesan agreement with Indegene, Inc. (“Indegene”). Planning and readiness efforts for a potential commercial launch are actively progressing. We have an agreement with Indegene for them to provide commercialization services for CTx-1301, including marketing, market access and pricing, commercial operations, and an omnichannel platform on a fee for service basis in the United States. We also have dedicated teams in place at Indegene across key functional areas including market access, medical education, prescriber and patient marketing, and digital infrastructure. Additionally, field-based sales representatives and corporate account directors will augment omnichannel promotional efforts through an agreement with IQVIA Inc. (IQVIA).

Except as provided in the Purchase Agreement, during the period commencing on and including the date of the Purchase Agreement and continuing through and including the 180th day following the date of the Purchase Agreement (such period being referred to as the Lock-up Period), each Purchaser willcould not, without the prior written consent of the Company, sell, offer to sell, contract to sell or lend any shares of of common stock or Warrant Shares (Securities). The Purchase Agreement also provides that during the Lock-up Period, the Purchasers willcould not (i) effect any short sale, or establish or increase any “put equivalent position” or liquidate or decrease any “call equivalent position” of any Securities; (ii) pledge, hypothecate or grant any security interest in any Securities; (iii) in any other way transfer or dispose of any Securities; (iv) enter into any swap, hedge or similar arrangement or agreement that transfers, in whole or in part, the economic risk of ownership of any Securities, regardless of whether any such transaction is to be settled in securities, in cash or otherwise; (v) grant any proxies or powers of attorney with respect to any Securities, deposit any Securities into a voting trust, or enter into a voting agreement or similar arrangement or commitment with respect to any Securities; or (vi) publicly announce the intention to do any of the foregoing.

During the three months ended MarchJune 31, 2026 and30, 2025, we sold 210,158 and 200,484364,963 shares of common stock, respectively, under the 2023 ATM Agreement, for net proceeds of $1,578,731, after deducting $54,363 of $1,304,011compensation to HCW and $1,020,368.other administration fees.

In July 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. During the quarterthree months ended MarchJune 31,30, 2026, we sold 1,611,8061,032,372 shares of common stock to to Lincoln Park, under the 2025 LP Purchase Agreement, for net proceeds of $9,006,786.$5,058,975. Subsequent to MarchJune 31,30, 2026, we sold 537,527220,476 shares of common stock to Lincoln Park, under the 2025 LP Purchase Agreement, for net proceeds of $2,884,717.$1,068,525.

During the quarterthree months ended March 31, 2026, we entered into exchange agreements with Lender to exchange an aggregate of $2,308,947 in principal, monitoring fee and interest for 460,122 shares of common stock, thereby extinguishing the 2024 Note.

Selling, General and Administrative Expenses

GeneralSelling, general and administrative (GSG&A) expenses consist primarily of (i) professional fees for legal, accounting, audit, tax and consulting services, (ii) salaries and related costs for our employees in administrative, executive and finance functions and (iii) pre-commercialization expenses for CTx-1301. GSG&A expenses also include insurance, office, and travel expenses.

We expect that our GSG&A expenses will increase in the future as we increase our GSG&A headcount to support our growing operations, including the potential commercialization of CTx-1301, and incur costs related to pre-commercialization activities. 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.

Comparison of the three months ended MarchJune 31,30, 2026 and 2025

The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025:

The following table summarizes our R&D expenses for the three months ended MarchJune 31,30, 2026 and 2025:

R&D expenses weredecreased $2.2$1.2 million, or 44.9%, to $1.5 million for the three months ended MarchJune 31, 30, 2026, afrom decrease$2.7 ofmillion 1.8% fromfor the three months ended MarchJune 31,30, 2025. The decrease iswas thedriven resultprimarily ofby lower clinical operations costs asfollowing the conclusion of clinical clinical study activities concluded in early 2025, offsetand by anthe increaseabsence inof the regulatory andcosts manufacturing activitiesincurred in the firstsecond quarter of 20262025 relatingin toconnection with preparing the NDACTx-1301 reviewNDA, ofwhich CTx-1301.was submitted on July 31, 2025.

GeneralSelling, general and administrative expenses

The following table summarizes our GSG&A expenses for the three months ended MarchJune 31,30, 2026 and 2025:

Total GSG&A expenses wereincreased $5.7$2.0 million, or 101.5%, to $3.9 million for the three months ended MarchJune 31,30, 2026, anfrom increase of $4.2$1.9 million or 287.0% fromfor the three three months ended MarchJune 31,30, 2025. ThisThe increase iswas driven primarily the result of costs incurred relating to planning andby commercial readiness efforts planning for the potential launch of CTx-1301, if approved by the FDA, including increased headcount and activities relating to market access, pricing, reimbursementreimbursement, and medical affairs incurredactivities conducted through Indegene, our primary commercial partner.

The following table summarizes the change in fair value of derivative and interest and other income (expense), net for the three months ended MarchJune 31,30, 2026 and 2025:

Change in fair value of derivative for the three months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025 relates to the 2025 LP Purchase Agreement and the change in fair value of the derivative asset or liability. Interest expense, net for the three months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025 relates to interest incurred on the 2024 Note and 2025 Note, offset by interest earned on invested balances. The increase in interest expense for the period ended March 31, 2026 is related to interest expense incurred on the 2024 Note and 2025 Note which were executed in December 2024 and November 2025, including loss on debt extinguishments.

Net cash used in operating activities was $6.9$12.8 million for the threesix months ended MarchJune 31,30, 2026. 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 $9.3$15.2 million, including the effects of significant significant noncash items, stock-based compensation expense of $0.6$1.0 million, change in fair value of derivative of $0.9$1.2 million, loss on debt extinguishment of $0.3$0.5 million, accretion of discount on note payable of $0.2 million and depreciation expense of $0.1$0.2 million. Changes in operating assets and liabilities included an increase in tradeprepaid accounts payableexpenses and accruedother expensescurrent assets of $1.3$0.7 million primarily due to accruedpayments pre-commercialization costs,for manufacturing materials and materialprofessional costs.fees.

Net cash used in operating activities was $4.6$9.4 million for the threesix months ended MarchJune 31,30, 2025. 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 $3.9$8.8 million, including the effects of significant noncash items, stock-based compensation expense of $0.4$0.5 million and depreciation expense of $0.2$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 $0.5$0.9 million primarily due to payments for professional and marketing fees.

Net cash used in investing activities for the three-monthsix-month period ended MarchJune 31,30, 2026 was primarily related to the purchase of equipment to to support our R&D activities.

Net cash provided by financing activities for the three-monthsix-month period ended MarchJune 31,30, 2026 was related to the cash proceeds from the issuance of securities pursuant to the Private Placement, 2023 ATM Agreement, 2026 ATM Agreement and the 2025 LP Purchase Agreement.

Net cash provided by financing activities for the three-monthsix-month period ended MarchJune 31,30, 2025 was related to the cash proceeds from the issuance of common stock pursuant to the 2023 ATM Agreement and the Original LP Purchase Agreement.

As of MarchJune 31,30, 2026, we had cash and cash equivalents of $25.9$28.4 million. Under our current business plan, we believe our cash will satisfy our capital needs into earlymid 2027. 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.

The following summarizes our contractual obligations as of MarchJune 31,30, 2026 that will affect our future liquidity.

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 $1,282,288,$1,223,587, the current portion of the operating lease liability was $246,864$255,132 and the long-term portion of the lease liability was $1,035,424$968,455 as of MarchJune 31,30, 2026.

Since inception we have been engaged in organizational activities, including raising capital and R&D 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 R&D. There can be no assurance that our R&D 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 MarchJune 31,30, 2026 and 2025 and had accumulated losses of $141.7$147.6 million since inception to MarchJune 31,30, 2026. 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 2023 ATM Agreement and 2026 ATM Agreement, Agreement, Original LP Purchase Agreement and 2025 LP Purchase Agreement, a private placement with WFIA, the WFIA Note, which was subsequently converted converted to equity, the June 2024 warrant inducement, the issuance of the 2024 Note, which was subsequently converted to equity, and 2025 Note and the Private Placement in February 2026. Additional capital will be needed by us to fund our operations, to complete development of of and to commercially develop our product candidates. There is no assurance that such capital will be available when needed or on acceptable terms.

Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404, (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis), and (iv) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the chief executive officer’s compensation to median employee compensation. These exemptions will apply until the fifth anniversary of the completion of our IPOIPO, which occurred in December 2021, or until we no longer meet the requirements for being an “emerging growth company,” whichever occurs first.