Cingulate Inc.
For the period ended Jun 30, 2026. Filed Aug 13, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 13, 2026
CING$4.26+0.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-14.
0001493152-26-022884
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-13.
0001493152-26-037606
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 100 previous paragraphs and 109 current paragraphs.
63 unchanged; 26 reworded; 16 added; 8 removed; 3 previous and 4 current paragraphs rearranged.
Tables are not compared: 9 previous and 14 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (16)
Current report
If approved, we plan to commercialize CTx-1301 in the United States. We continue to advance our commercialization preparations, with dedicated teams established across all key functional areas. Our launch strategy leverages a commercialization strategy augmented by AI-driven tools designed to optimize targeting, decision-making, and performance measurement — positioning us for a rapid commercial launch contingent upon FDA approval. Key areas of focus include:
Current report
On June 16, 2026, the United States Patent and Trademark Office issued U.S. Patent No. 12,653,791 covering CTx-1301. The patent protects key aspects of CTx-1301’s formulation and method of use through December 2042 and represents the first U.S. patent wholly owned by the Company covering CTx-1301, further strengthening our intellectual property portfolio surrounding our PTR platform.
Current report
During the three months ended June 30, 2026, the Company entered into exchange agreements with Avondale to exchange an aggregate of $1,320,000 in principal for 147,301 shares of common stock and aggregate cash payments of $660,000, thereby extinguishing that portion of the promissory note with Avondale. Subsequent to June 30, 2026, the Company entered into exchange agreements with Avondale to exchange an aggregate of $1,320,000 in principal for 139,751 shares of common stock and a cash payments of $600,000, thereby extinguishing that portion of the promissory note with Avondale.
Current report
Selling, General and Administrative Expenses
Current report
R&D expenses decreased $1.2 million, or 44.9%, to $1.5 million for the three months ended June 30, 2026, from $2.7 million for the three months ended June 30, 2025. The decrease was driven primarily by lower clinical operations costs following the conclusion of clinical study activities in early 2025, and by the absence of the regulatory costs incurred in the second quarter of 2025 in connection with preparing the CTx-1301 NDA, which was submitted on July 31, 2025.
Current report
Selling, general and administrative expenses
Current report
The following table summarizes our SG&A expenses for the three months ended June 30, 2026 and 2025:
Current report
Comparison of the six months ended June 30, 2026 and 2025
Current report
Research and development expenses
Current report
R&D expenses decreased approximately $1.3 million, or 25.4%, to $3.7 million for the six months ended June 30, 2026, from $4.9 million for the six months ended June 30, 2025. The decrease was driven primarily by lower clinical operations costs following the conclusion of clinical studies in early 2025 and the absence of increased NDA-preparation regulatory costs incurred in the prior-year period, partially offset by increased manufacturing activities in the first half of 2026 related to CTx-1301 as well as increased personnel costs.
Current report
Selling, general and administrative expenses
Current report
The following table summarizes our SG&A expenses for the six months ended June 30, 2026 and 2025:
Current report
Total SG&A expenses increased approximately $6.2 million, or 181.7%, to $9.7 million for the six months ended June 30, 2026, from $3.4 million for the six months ended June 30, 2025, reflecting the progressive build-out of commercial readiness capabilities across the first half of the year, including headcount additions and expanded market access, pricing, reimbursement, and medical affairs activity through Indegene, our primary commercialization partner.
Current report
Change in fair value of derivative for the six-months ended June 30, 2026 relates to the 2025 LP Purchase Agreement and remeasurement of the associated derivative asset or liability. Interest expense, net reflects interest incurred on the 2024 Note and 2025 Note, partially offset by interest earned on invested cash balances.
Current report
During the three months ended June 30, 2026, we sold 1,032,372 shares of common stock under the 2025 LP Purchase Agreement, for net proceeds of $5,058,975. Subsequent to June 30, 2026, we sold 220,476 shares of common stock under the 2025 LP Purchase Agreement, for net proceeds of $1,068,525.
Current report
We entered into agreements with Bend Bioscience, our CDMO, for CMC work to be completed relating to the resubmission of our NDA for CTx-1301 includingthe manufacturing of our verification batches with a total cost of approximately $1.6 million.
Removed paragraphs (8)
Previous report
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. As part of the NDA review process, the FDA has requested additional CMC-related information. The Company is working closely with the FDA to address these requests. Depending on the timing and scope of these requests and responses, the FDA may require additional time to evaluate the information provided.
Previous report
On April 24, 2026, the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for a patent application covering CTx-1301, originally issued on March 17, 2026.
Previous report
During the three months ended March 31, 2026 and 2025, we sold 210,158 and 200,484 shares of common stock, respectively, under the 2023 ATM Agreement, for net proceeds of $1,304,011 and $1,020,368.
Previous report
General and Administrative Expenses
Previous report
R&D expenses were $2.2 million for the three months ended March 31, 2026, a decrease of 1.8% from the three months ended March 31, 2025. The decrease is the result of lower clinical operations costs as clinical study activities concluded in early 2025, offset by an increase in regulatory and manufacturing activities in the first quarter of 2026 relating to the NDA review of CTx-1301.
Previous report
General and administrative expenses
Previous report
The following table summarizes our G&A expenses for the three months ended March 31, 2026 and 2025:
Previous report
During the three months ended March 31, 2026, we sold 1,611,806 shares of common stock under the 2025 LP Purchase Agreement, for net proceeds of $9,006,786. Subsequent to March 31, 2026, we sold 537,527 shares of common stock under the 2025 LP Purchase Agreement, for net proceeds of $2,884,717.
Reworded paragraphs (26)
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 $151.9 million as of March 31, 2026.
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 $160.4 million as of June 30, 2026.
Previous wording
We have incurred significant losses since our inception. Our net losses were $9.3 million and $3.9 million for the three months ended March 31, 2026 and 2025, respectively. See “Results of Operations” below for an explanation of the fluctuations in our net losses. As of March 31, 2026, we had an accumulated deficit of $141.7 million.
Current wording
We have incurred significant losses since our inception. Our net losses were $5.9 million and $5.0 million for the three months ended June 30, 2026 and 2025, respectively. See “Results of Operations” below for an explanation of the fluctuations in our net losses. As of June 30, 2026, we had an accumulated deficit of $147.6 million.
Previous wording
As of March 31, 2026, we had cash and cash equivalents of $25.9 million, which we believe will be sufficient to fund our operations into early 2027, including the costs associated with 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 programs. See “Liquidity and Capital Resources” below.
Current wording
As of June 30, 2026, we had cash and cash equivalents of $28.4 million, which we believe will be sufficient to fund our operations into mid 2027, including 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.
Previous wording
There can be no assurance that approval of CTx-1301 will occur on or about the PDUFA date or that approval of CTx-1301 will occur at all. See Risk Factors section of our Form 10-K for more information about the risks related to regulatory approval of CTx-1301.
Current wording
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. On June 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 as promptly as practicable. There can be no assurance regarding the timing of any resubmission, that any resubmission will be accepted by the FDA, that approval of CTx-1301 will occur 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 risks related to regulatory approval of CTx-1301.
Previous wording
CoreRx, Inc., doing business as Bend Biosciences, 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.
Current wording
Bend 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.
Previous wording
If approved, we plan to commercialize CTx-1301 in the United States through our master services 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).
Current wording
We have an agreement with Indegene, Inc. (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.
Previous wording
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 will not, without the prior written consent of the Company, sell, offer to sell, contract to sell or lend any shares of common stock or Warrant Shares (Securities). The Purchase Agreement also provides that during the Lock-up Period, the Purchasers will 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.
Current wording
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 could not, without the prior written consent of the Company, sell, offer to sell, contract to sell or lend any shares of common stock or Warrant Shares (Securities). The Purchase Agreement also provides that during the Lock-up Period, the Purchasers could 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.
Previous wording
In the three months ended March 31, 2026, we sold 210,158 shares of common stock under the 2023 ATM Agreement, for net proceeds of $1,304,011, after deducting $43,300 of compensation to HCW and other administration fees.
Current wording
During the three months ended June 30, 2025, we sold 364,963 shares of common stock, respectively, under the 2023 ATM Agreement, for net proceeds of $1,578,731, after deducting $54,363 of compensation to HCW and other administration fees.
Previous wording
During the three months ended March 31, 2026, we sold 2,700 shares of common stock under the 2026 ATM Agreement, for net proceeds of $17,546, after deducting $558 of compensation to A.G.P. and other administration fees. Subsequent to March 31, 2026, we sold 791,836 shares of common stock under the 2026 ATM Agreement, for net proceeds of $4,269,943, after deducting $133,927 of compensation to A.G.P. and other administration fees.
Current wording
During the three months ended June 30, 2026, we sold 806,893 shares of common stock under the 2026 ATM Agreement, for net proceeds of $4,347,364, after deducting $136,364 of compensation to A.G.P. and other administration fees. Subsequent to June 30, 2026, we sold 271,717 shares of common stock under the 2026 ATM Agreement, for net proceeds of $1,394,179, after deducting $43,751 of compensation to A.G.P. and other administration fees.
Previous wording
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 quarter ended March 31, 2026, we sold 1,611,806 shares of common stock to Lincoln Park, under the 2025 LP Purchase Agreement, for net proceeds of $9,006,786. Subsequent to March 31, 2026, we sold 537,527 shares of common stock to Lincoln Park, under the 2025 LP Purchase Agreement, for net proceeds of $2,884,717.
Current wording
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 three months ended June 30, 2026, we sold 1,032,372 shares of common stock to Lincoln Park, under the 2025 LP Purchase Agreement, for net proceeds of $5,058,975. Subsequent to June 30, 2026, we sold 220,476 shares of common stock to Lincoln Park, under the 2025 LP Purchase Agreement, for net proceeds of $1,068,525.
Previous wording
During the quarter 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.
Current wording
During the three 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.
Previous wording
General and administrative (G&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. G&A expenses also include insurance, office, and travel expenses.
Current wording
Selling, general and administrative (SG&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. SG&A expenses also include insurance, office, and travel expenses.
Previous wording
We expect that our G&A expenses will increase in the future as we increase our G&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.
Current wording
We expect that our SG&A expenses will increase in the future as we increase our SG&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.
Previous wording
Total G&A expenses were $5.7 million for the three months ended March 31, 2026, an increase of $4.2 million or 287.0% from the three months ended March 31, 2025. This increase is primarily the result of costs incurred relating to planning and commercial readiness efforts for the launch of CTx-1301, if approved by the FDA, including increased headcount and activities relating to market access, pricing, reimbursement and medical affairs incurred through Indegene, our commercial partner.
Current wording
Total SG&A expenses increased $2.0 million, or 101.5%, to $3.9 million for the three months ended June 30, 2026, from $1.9 million for the three months ended June 30, 2025. The increase was driven primarily by commercial readiness planning for the potential launch of CTx-1301, including increased headcount and market access, pricing, reimbursement, and medical affairs activities conducted through Indegene, our primary commercial partner.
Previous wording
Change in fair value of derivative for the three months ended March 31, 2026 and March 31, 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 March 31, 2026 and March 31, 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.
Current wording
Change in fair value of derivative for the three months ended June 30, 2026 and June 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 June 30, 2026 and June 30, 2025 relates to interest incurred on the 2024 Note and 2025 Note, offset by interest earned on invested balances.
Previous wording
Net cash used in operating activities was $6.9 million for the three months ended March 31, 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 million, including the effects of significant noncash items, stock-based compensation expense of $0.6 million, change in fair value of derivative of $0.9 million, loss on debt extinguishment of $0.3 million, accretion of discount on note payable of $0.2 million and depreciation expense of $0.1 million. Changes in operating assets and liabilities included an increase in trade accounts payable and accrued expenses of $1.3 million primarily due to accrued pre-commercialization costs, manufacturing and material costs.
Current wording
Net cash used in operating activities was $12.8 million for the six months ended June 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 $15.2 million, including the effects of significant noncash items, stock-based compensation expense of $1.0 million, change in fair value of derivative of $1.2 million, loss on debt extinguishment of $0.5 million, accretion of discount on note payable of $0.2 million and depreciation expense of $0.2 million. Changes in operating assets and liabilities included an increase in prepaid expenses and other current assets of $0.7 million primarily due to payments for manufacturing materials and professional fees.
Previous wording
Net cash used in operating activities was $4.6 million for the three months ended March 31, 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 million, including the effects of significant noncash items, stock-based compensation expense of $0.4 million and depreciation expense of $0.2 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 million primarily due to payments for professional and marketing fees.
Current wording
Net cash used in operating activities was $9.4 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 to develop our product candidates resulting in a net loss of $8.8 million, including the effects of significant 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 $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.
Previous wording
Net cash used in investing activities for the three-month period ended March 31, 2026 was primarily related to the purchase of equipment to support our R&D activities.
Current wording
Net cash used in investing activities for the six-month period ended June 30, 2026 was primarily related to the purchase of equipment to support our R&D activities.
Previous wording
Net cash provided by financing activities for the three-month period ended March 31, 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.
Current wording
Net cash provided by financing activities for the six-month period ended June 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.
Previous wording
Net cash provided by financing activities for the three-month period ended March 31, 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.
Current 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 2023 ATM Agreement and the Original LP Purchase Agreement.
Previous wording
As of March 31, 2026, we had cash and cash equivalents of $25.9 million. Under our current business plan, we believe our cash will satisfy our capital needs into early 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.
Current wording
As of June 30, 2026, we had cash and cash equivalents of $28.4 million. Under our current business plan, we believe our cash will satisfy our capital needs into mid 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.
Previous wording
Since our inception in 2012 through March 31, 2026, we have not generated any revenue and have incurred significant operating losses and negative cash flow from our operations.
Current wording
Since our inception in 2012 through June 30, 2026, we have not generated any revenue and have incurred significant operating losses and negative cash flow from our operations. We have funded our operations primarily through private and public equity and debt financings. In February 2026, we received gross proceeds of $12,011,000 from the Private Placement.
Previous wording
In the three months ended March 31, 2026, we sold 2,700 shares of common stock under the 2026 ATM Agreement, for net proceeds of $17,546, after deducting $558 of compensation to A.G.P. and other administration fees. Subsequent to March 31, 2026, we sold 791,836 shares of common stock under the 2026 ATM Agreement, for net proceeds of $4,269,943, after deducting $133,927 of compensation to A.G.P. and other administration fees.
Current wording
In the three months ended June 30, 2026, we sold 806,893 shares of common stock under the 2026 ATM Agreement, for net proceeds of $4,347,364, after deducting $136,364 of compensation to A.G.P. and other administration fees. Subsequent to June 30, 2026, we sold 271,717 shares of common stock under the 2026 ATM Agreement, for net proceeds of $1,394,179, after deducting $43,751 of compensation to A.G.P. and other administration fees.
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 $1,282,288, the current portion of the operating lease liability was $246,864 and the long-term portion of the lease liability was $1,035,424 as of March 31, 2026.
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 $1,223,587, the current portion of the operating lease liability was $255,132 and the long-term portion of the lease liability was $968,455 as of June 30, 2026.
Previous wording
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 March 31, 2026 and 2025 and had accumulated losses of $141.7 million since inception to March 31, 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 ATM Agreement and 2026 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, 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 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 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 June 30, 2026 and 2025 and had accumulated losses of $147.6 million since inception to June 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, 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, 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 and to commercially develop our product candidates. There is no assurance that such capital will be available when needed or on acceptable terms.
Previous wording
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 IPO or until we no longer meet the requirements for being an “emerging growth company,” whichever occurs first.
Current wording
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 IPO, which occurred in December 2021, or until we no longer meet the requirements for being an “emerging growth company,” whichever occurs first.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:
Current report — wording carried from elsewhere
The following table summarizes our R&D expenses for the six months ended June 30, 2026 and 2025:
Current report — wording carried from elsewhere
The following table summarizes the change in fair value of derivative and interest and other income (expense), net for the six months ended June 30, 2026 and 2025:
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Change in fair value of derivative and interest and other income (expense), net
Previous report — wording carried elsewhere
Change in fair value of derivative and interest and other income (expense), net
Previous report — wording carried elsewhere
In February 2026, we received gross proceeds of $12,011,000 from the Private Placement.