Inhibikase Therapeutics, Inc.
For the period ended Mar 31, 2026. Filed May 12, 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.
Mar 31, 2026 · Filed May 12, 2026
IKT$1.50+4.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0001193125-25-283169
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-12.
0001193125-26-219641
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 118 previous paragraphs and 112 current paragraphs.
59 unchanged; 30 reworded; 23 added; 25 removed; 4 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 previous and 3 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 (23)
Current report
Recent Developments
Current report
In April 2026, we announced that the first patient was enrolled in the Company’s single global pivotal Phase 3 study, known as IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332). Enrollment of patients and activation of clinical sites in IMPROVE-PAH is ongoing with the Company pursuing regulatory approvals in more than 25 countries globally. We are one of the first companies to successfully take advantage of “Facilitating and Accelerating Strategic Trials in the European Union”, called FAST-EU, which is a pilot initiative that commenced on January 30, 2026 to accelerate the approval of multinational clinical trials. Recently, the Company received a determination from the European Medicines Agency that the Company is permitted to initiate IMPROVE-PAH in twelve (12) European countries, for a total of sixteen (16) countries approved globally including the United States, Canada, New Zealand and Argentina, with site activations expected to commence gradually during the remainder of 2026.
Current report
In April 2026, Inhibikase submitted an Orphan Drug Designation (“ODD”) application to the U.S. Food and Drug Administration for IKT-001 for PAH recognizing that PAH is a high unmet medical need impacting approximately 50,000 Americans.
Current report
Research and Development
Current report
the ability of our products to adequately exhibit product features (safety, efficacy, convenience) that are attractive to physicians and patients relative to offerings of our competitors;
Current report
(2) Other research and development expenses include stock-based compensation expense of $1.8 million and $0.5 million for the three months ended March 31, 2026 and 2025, respectively.
Current report
Selling, General and Administrative
Current report
Research and Development
Current report
Selling, General and Administrative
Current report
Other Income
Current report
any costs, including upfront of or licensing costs, associated with new programs such as any in-licensed new compounds or expanded indications of IKT-001;
Current report
Cash Provided by Financing Activities
Current report
Lease Obligations
Current report
We previously leased office space in Lexington, Massachusetts under an operating lease that expired on September 30, 2025. As of March 31, 2026, we have no remaining lease obligations under this arrangement. We expect to receive a refund of our security deposit, which is held in escrow, during the second quarter of 2026. The refund is not expected to have a material impact on our liquidity or results of operations.
Current report
Clinical and Manufacturing Agreements
Current report
We have entered into various agreements with contract research organizations ("CROs") and contract manufacturing organizations ("CMOs") to support our ongoing Phase 3 clinical study, IMPROVE-PAH, as well as related manufacturing activities. These agreements generally include both fixed and variable components and, in certain cases, are non-cancelable or subject to termination fees.
Current report
As of March 31, 2026, our estimated remaining contractual commitments under these arrangements, excluding performance-based milestone payments, were approximately $58.4 million for CRO services and $9.2 million for CMO services, which we expect to incur primarily through 2030. The timing of these expenditures is dependent on several factors, including patient enrollment rates, clinical site activation, and manufacturing production schedules.
Current report
A portion of our CRO commitments includes performance-based milestone payments, of which approximately $7.5 million of the total contracted value is contingent upon the achievement of specified criteria by the vendor. The timing and likelihood of these payments are uncertain and depend on the progress and outcomes of the clinical trial. While one milestone has been achieved to date, the remaining milestones are not currently considered probable and, accordingly, are not reflected in our accrued liabilities as of March 31, 2026.
Current report
In April 2026, we entered into change orders under our existing CMO agreements, increasing our total manufacturing commitments by approximately $0.6 million, reflecting updates to our anticipated production requirements.
Current report
We expect that our contractual commitments will represent a significant portion of our future cash outflows as we advance our IMPROVE-PAH clinical trial and related manufacturing activities. The majority of these costs are expected to be incurred over the next two to three years, although the actual timing may vary based on clinical and operational factors.
Current report
Smaller Reporting Company Status
Current report
Effective as of December 31, 2025, we no longer qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012. As such, we are subject to additional expenses that we did not previously incur in complying with the Sarbanes-Oxley Act of 2002 (“SOX”) and rules implemented by the SEC. We are also subject to certain disclosure requirements that are applicable to other public companies that were not applicable to us as an emerging growth company, for example, compliance 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 consolidated financial statements and compliance with the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
Current report
However, we continue to qualify as a “smaller reporting company,” as defined in the Securities Exchange Act of 1934, as amended, or Exchange Act, and have elected to take advantage of certain of the scaled disclosures available to smaller reporting companies. To the extent that we continue to qualify as a “smaller reporting company” as such term is defined in Rule 12b-2 under the Exchange Act, certain of the exemptions available to us as an “emerging growth company” continue to be available to us as a “smaller reporting company,” including exemption from compliance with the auditor attestation requirements pursuant to SOX and reduced disclosure about our executive compensation arrangements. We will continue to be a “smaller reporting company” for so long as we have either (i) a public float of less than $250 million measured as of the last business day of our most recently completed second fiscal quarter, or (ii) annual revenue of less than $100 million during our most recently completed fiscal year and either no public float or a public float of less than $700 million measured as of the last business day of our most recently completed second fiscal quarter.
Removed paragraphs (25)
Previous report
We were previously pursuing risvodetinib (also known as IkT-148009), a selective inhibitor of the non-receptor Abelson Tyrosine Kinases that targets the treatment of Parkinson’s disease, but we have discontinued and outlicensed this program.
Previous report
IKT-001 and PAH
Previous report
IKT-001 emerged from our medicinal chemistry program that aimed to develop improvements to drugs that inhibit Abelson Tyrosine Kinase and type III receptor tyrosine kinases. IKT-001, a novel oral prodrug of imatinib mesylate, was designed to improve areas of the molecule that might play a role in the gastrointestinal (“GI”) side effects commonly observed with oral imatinib mesylate. A three-part dose finding/dose equivalence study in 66 healthy volunteers (known as ‘the 501 trial’) was completed with IKT-001 in 2023. The study was designed to evaluate the 96-hour single-dose pharmacokinetics of imatinib delivered as IKT-001 and determine the dose relationship between IKT-001 and imatinib mesylate. Based on this study it was determined that bioequivalence was established with a 300 mg dose of IKT-001 to a dose of 230 mg of imatinib mesylate while a 500 mg dose of IKT-001 was established as bioequivalent to a dose of 383 mg of imatinib mesylate. These doses are adequate to cover the target systemically and were similar to the doses of imatinib mesylate used in the Phase 3 IMPRES trial in PAH.
Previous report
On January 19, 2024, we met with the Food and Drug Administration (“FDA”) Hematological Malignancy Review Team (“Review Team”) in a Pre-New Drug Application (“pre-NDA”), meeting to discuss our bioequivalence studies of IKT-001 and its path to approval. All questions were addressed and summarized in official meeting minutes issued by the FDA on February 12, 2024. During the meeting, we inquired whether additional clinical studies would be needed to seek approval and discussed manufacturing and quality control requirements for approval. The Review Team acknowledged that the 505(b)(2) pathway appeared to be the appropriate pathway for approval of IKT-001.
Previous report
PAH is a rare disease of the pulmonary microvasculature found in 15 to 50 persons per million within the United States and Europe. The global PAH market size was valued at $7.66 billion in 2023 and is estimated to grow at a compound annual growth rate of 3.3% through 2034. Most of the treatments that constitute the standard of care (e.g. ERAs, PDE5s, prostacyclins) primarily act as vasodilators. In 2024, sotatercept was approved for the treatment of PAH on top of standard-of-care (“SOC”). Sotatercept, branded as WINREVAIR, is recombinant fusion protein that acts as a trap for transforming growth factor-beta superfamily ligands, including activin A and bone morphogenetic protein 9. These ligands may play a role in the development and progression of PAH by promoting cell proliferation and fibrosis.
Previous report
Sotatercept was launched by Merck & Co in 2024 and is presently generating, on an annualized basis, approximately $1.4 billion in sales with quarter-on-quarter growth rate since launch. The success of sotatercept has created renewed enthusiasm around the anti-proliferative pathways in PAH. As previously mentioned, imatinib inhibits Abelson Tyrosine Kinase and type III receptor tyrosine kinases and through these pathways inhibits platelet-derived growth factor receptor which are involved in cell proliferation and migration as well as stem cell factor receptor (c-KIT) which modulates mast cell and hematopoietic stem cell activity. Through these targets imatinib may inhibit vascular cell proliferation, migration and fibrosis. Thus, targeting the type III receptor tyrosine kinase pathway may provide an alternate mechanism for disease modification in PAH.
Previous report
The first reports of the use of imatinib in PAH were published in 2005 and 2006. A Phase 2, randomized control trial, was subsequently conducted showing clinical benefit of imatinib in PAH. In 2013, the outcome of a Phase 3 trial (IMPRES) evaluating imatinib mesylate as a treatment for PAH was reported, demonstrating that imatinib may improve key parameters associated with PAH. In this study, imatinib improved exercise capacity and hemodynamics in patients with advanced PAH but approval was precluded because of the bleeding risk associated with concomitant anti-coagulant therapy and the high discontinuation rate in the imatinib group.
Previous report
As we considered revisiting the use of imatinib in PAH, we recognized that changes in SOC for these patients may have alleviated much of the safety risk previously observed for imatinib in PAH patients. This analysis prompted us to file a pre-IND (“PIND”) meeting request to discuss the application of IKT-001 as a potential disease-modifying treatment for PAH. To evaluate this further, members of the Company met with the FDA Division of Cardiology and Nephrology in a PIND meeting to discuss our plan to utilize IKT-001 in a Phase 2b efficacy, safety and tolerability study in PAH. At the meeting, the FDA confirmed that IKT-001 would be viewed as a New Molecular Entity (“NME”) and that the appropriate path for approval remained to be the 505(b)(2) statute. This opens up the possibility of IKT-001 being granted NME status and market exclusivity on approval. The FDA requested at the PIND meeting that we conduct a cell-culture based study of the human Ether-a-go-go-related Gene (“hERG”) ion channel, a standard cardiovascular safety test performed for any NME for which a new Investigative New Drug Application (“IND”) is to be opened. IKT-001 weakly inhibits hERG and imatinib has an IC50 of 14.5 uM. Following completion of this study, the IND was filed with the FDA on August 9, 2024 and we were cleared to initiate a Phase 2b trial on September 9, 2024.
Previous report
On October 21, 2024, we closed a private placement with gross proceeds of approximately $110 million, before deducting placement fees and offering expenses, to support this program. If the warrants issued in such offering are exercised for cash, the total gross proceeds from the financing may be up to $275 million. We intend to use the net proceeds from the private placement to finance the initiation of a Phase 2b trial in PAH and for general corporate purposes. We have had discussions with the FDA regarding Orphan Drug Designation (“ODD”) for delivery of imatinib by IKT-001 for PAH and plan to apply for ODD once the required pre-clinical studies are complete.
Previous report
More recently, a contemporary study published in the American Journal of Respiratory and Critical Care Medicine in an open label, single arm, four (4) center study with seventeen (17) patients confirmed that imatinib was generally well tolerated (with zero discontinuations for tolerance or side effects) in World Health Organization (“WHO”) Group 1 PAH population, and demonstrated a treatment effect on total pulmonary resistance (“TPR”) that compares favorably with other novel therapies for PAH, including sotatercept and seralutinib. Acknowledging the limitations of cross study comparisons and the small size of the study, we believe this recent study supports our thesis that systemic exposure of imatinib can be well tolerated and provide strong efficacy to patients suffering from PAH.
Previous report
During the first half of 2025, we considered potential study designs and obtained feedback from various key opinion leaders before finalizing a clinical trial protocol for our forthcoming Phase 2b study, known as IMPROVE-PAH. IMPROVE-PAH is a multi-center, randomized, double-blind, placebo-controlled study of approximately 150 PAH participants. Participants under IMPROVE-PAH will be randomized 1:1:1 to receive 300 mg IKT-001, 500 mg IKT-001, or placebo once daily for 26 weeks, in addition to stable background PAH therapy. Our bioequivalence studies previously confirmed that 500 mg IKT-001 has comparable exposure in humans to 383 mg of imatinib mesylate. The primary efficacy endpoint is change in pulmonary vascular resistance (PVR) at Week 26. Secondary endpoints include 6-minute walk distance (6MWD), WHO functional class, and pharmacokinetics. Exploratory endpoints include echocardiographic and hemodynamic measures, NT-proBNP, IL-6, EmPHasis-10 score, and the incidence of clinical worsening events. Safety will be assessed by the incidence and severity of treatment emergent adverse events. The study protocol also includes an interim safety review for study continuance by the Data Safety Monitoring Board with at least fifty (50) patients at 12-weeks of follow-up. We remain on track to initiate IMPROVE-PAH in the fourth quarter of 2025 with up to 120 clinical sites expected to be activated to assess whether IKT-001 offers a clinically meaningful reduction in PVR with acceptable tolerability in patients with moderate to severe PAH. Results may inform the potential of IKT-001 as a novel anti-proliferative treatment option targeting vascular remodeling pathways in PAH. In parallel with the above efforts to initiate IMPROVE-PAH in the fourth quarter of 2025, we are continuing to interact with the FDA regarding our Phase 3 strategy in PAH.
Previous report
We currently have commercialization rights to IKT-001 and patent protection in the United States until 2033 for IKT-001 with upcoming patent application filings potentially extending patent protection for certain methods of treatment using IKT-001 until 2044.
Previous report
Two families of patents and applications cover compositions of matter for IKT-001 and related chemical compounds, as well as methods of using those compositions. One family includes two issued U.S. patents: U.S. Patent No. 9,487,500, which claims a genus of compounds including IKT-001, and U.S. Patent No. 9,907,796, which claims methods of using a genus of compounds, including IKT-001, to treat certain tumoral disease and certain infectious diseases. These U.S. Patents will expire between 2033 and 2034, not including any potential patent term extensions. This family does not include any pending patent applications in the U.S. Outside the U.S., this family includes issued patents in Europe, Japan, and Australia, and a pending patent application in Canada. Outside the U.S., patents issuing from the applications in this family, if granted, will expire in 2033, not taking into account any potential patent term adjustments or extensions that may be available in the future. This family of patents and applications was jointly owned by us and Sphaera. Under the terms of our collaborative research and development agreement with Pivot Investment Holdings Pte. Ltd. (“Pivot”), the named successor to Sphaera, we have the exclusive right to commercialize certain compounds disclosed in these applications, including IKT-001, for cancer treatments.
Previous report
In addition to the jointly-owned patents, we exclusively own a second patent family, which includes a pending PCT application that covers methods of using IKT-001 to treat PAH. Patents issuing from national applications based on this PCT application will expire in 2044, not taking into account any potential patent term adjustments or extensions that may be available in the future. Because patent term extensions in the US are limited to a maximum of five years, we expect that any U.S. Patent arising from our previous collaboration with Sphaera that is extended will expire no later than 2039, over five years before the expiration of patents that issue based on our PCT application covering methods of using IKT-001 to treat PAH. We thus expect that these future patents, if granted, will protect our planned commercialization of IKT-001 to treat PAH independently from and after the expiration of our jointly owned U.S. patents.
Previous report
the impact of the outbreak of the COVID-19 pandemic or other future pandemics;
Previous report
Change in fair value contingent consideration increased by $492,827 or 100% from $0 in the prior comparable period. The increase is due to the change in fair value of the contingent consideration related to the CorHepta transaction from June 30, 2025 to September 30, 2025.
Previous report
Interest Income
Previous report
Research and development expenses increased by $13,417,261 or 133.9% to $23,434,243 from $10,016,982 in the prior comparable period. The increase was primarily due to a $11.5 million increase in the PAH program and other research and development expenses, together with a $9.2 million research and development expense related to the CorHepta transaction comprising a one-time (non-cash) expense charge for the acquired IPR&D related to the CorHepta acquisition cost of $7.4 million and $1.8 million of stock-based compensation expense. These increases were offset by a decrease of $7.3 million in the discontinued (outlicensed) risvodetinib (IkT-148009) program.
Previous report
Selling, general and administrative expenses increased by $11,137,139 or 197.3% to $16,780,525 from $5,643,386 in the prior comparable period. The $11.1 million increase was primarily driven by an increase of $2.9 million in personnel-related costs, including severance costs for the Company's former Chief Executive Officer and Chief Financial Officer, $1.2 million in legal, and consulting-related fees, and an increase of $6.9 million in stock-based compensation expense.
Previous report
Interest Income
Previous report
Cash Provided by Investing Activities
Previous report
On April 18, 2022, we entered into an operating lease agreement through September 30, 2025 for our office space in Lexington, Massachusetts. The Lexington lease contained escalating payments during the lease period. Upon execution of this lease agreement, we prepaid one month of rent, which applied to the first month's rent, and a security deposit, which is held in escrow and will be credited after the termination of the lease with the refund expected in the first half of 2026. Our total lease obligation at September 30, 2025 is $0.
Previous report
On July 1, 2025, we entered into a clinical trial supply agreement in the amount of approximately $6.5 million with a clinical trial supply organization whereby the clinical trial supply organization will provide services for our PAH Phase 2b clinical study, known as IMPROVE-PAH. The total remaining contract costs as of September 30, 2025 were approximately $6.3 million. The estimated period of performance for the committed work with the clinical trial supply organization is through 2029.
Previous report
On August 8, 2025, we entered into an arrangement with a contract research organization(“CRO”) to support our PAH Phase 2b clinical study known as IMPROVE-PAH in the amount of approximately $24.8 million, of which $2.5 million is subject to achievement of certain performance milestones by the CRO. The total remaining contract costs as of September 30, 2025 were approximately $19.0 million. The estimated period of performance for the committed work with the CRO is through 2027. We prepaid $1.0 million to the CRO, which will be held as a retainer until the end of the study and applied against the final invoice.
Previous report
The amount and timing of any such payments related to the $2.5 million performance milestones are contingent upon the vendor meeting specific contractual criteria. As of September 30, 2025, the achievement of these milestones is not considered probable, and the potential payments cannot be reasonably estimated. Accordingly, no liability has been recorded in the accompanying consolidated financial statements. We will continue to evaluate this arrangement each reporting period and will recognize a liability when achievement of the milestones become probable, and the amount can be reasonably estimated.
Reworded paragraphs (30)
Previous wording
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q (this “Quarterly Report”) and our audited financial statements and related notes thereto for the year ended December 31, 2024 included in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission (the “SEC”) on March 27, 2025 (the “Annual Report”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks, uncertainties, and assumptions. Factors that might cause future results to differ materially from those projected in the forward-looking statements include, but are not limited to, those set forth in our Annual Report and in other filings with the SEC.
Current wording
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q (this “Quarterly Report”) and our audited financial statements and related notes thereto for the year ended December 31, 2025 included in our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the Securities and Exchange Commission (the “SEC”) on March 26, 2026 (the “Annual Report”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks, uncertainties, and assumptions. Factors that might cause future results to differ materially from those projected in the forward-looking statements include, but are not limited to, those set forth in the Annual Report and in other filings with the SEC.
Previous wording
We are a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), that arise from aberrant signaling through the Abelson Tyrosine Kinase, and type III receptor tyrosine kinases including platelet derived growth factor receptors and c-KIT. Our lead product candidate is IKT-001, a prodrug of imatinib mesylate, for PAH which is an orphan indication. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans. We have completed non-human primate safety studies and a bioequivalence clinical trial in healthy volunteers to determine the doses of IKT-001 that are equivalent to imatinib mesylate and the results have been utilized to set the doses for a forthcoming Phase 2b study for approximately 150 PAH patients that we expect to initiate during the fourth quarter of 2025.
Current wording
We are a clinical-stage pharmaceutical company developing IKT-001 for Pulmonary Arterial Hypertension (“PAH”). Our lead product candidate, known as IKT-001, a prodrug of imatinib mesylate (“imatinib”), for PAH which is an orphan indication. Imatinib was first approved in the United States in 2001 for various cancers and blood disorders and, following more than 20 years of clinical use, has a well-characterized safety profile with the first reported use of imatinib in PAH occurring in 2005. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans. We have completed a non-human primate safety study and a bioequivalence clinical study in healthy volunteers to determine the doses of IKT-001 that are equivalent to imatinib. Our Phase 3 clinical study, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH), which is a single pivotal global study, is presently enrolling patients.
Previous wording
our ability to commence and conduct trials;
Current wording
our ability to commence and conduct trials, including recruiting sufficient patients, on a timely basis or at all;
Previous wording
(1) This amount includes a one-time (non-cash) charge of $7.4 million for the acquired IPR&D related to the CorHepta acquisition.
Current wording
(1) The March 31, 2025 amount includes a one-time (non-cash) charge of $7.4 million for the acquired IPR&D related to the acquisition of CorHepta Pharmaceuticals, Inc.(“CorHepta”).
Previous wording
Selling, general and administrative expenses include personnel-related expenses, such as salaries, benefits, travel and non-cash stock-based compensation expense, expenses for outside professional services and allocated expenses. Outside professional services consist of legal, accounting and audit services, investor relations services and other consulting fees. Allocated expenses consist of rent expenses related to our former office in Lexington, Massachusetts not otherwise included in research and development expenses.
Current wording
Selling, general and administrative expenses include personnel-related expenses, such as salaries, benefits, travel and non-cash stock-based compensation expense, expenses for outside professional services and allocated expenses. Outside professional services consist of legal, accounting and audit services and other consulting fees. Allocated expenses consist of rent expenses related to our former office in Lexington, Massachusetts not otherwise included in research and development expenses.
Previous wording
Research and development expenses increased by $3,459,824 or 82.6% to $7,649,697 from $4,189,873 in the prior comparable period. The $3.5 million increase in research and development expenses was primarily due to an increase of $4.8 million in PAH expenses, a decrease of $2.5 million in the risvodetinib (IkT-148009) program, which has been discontinued and outlicensed to ABLi Therapeutics, Inc., and a net increase of $1.1 million in other research and development expenses, including $0.7 million of stock-based compensation expense related to the acquisition of CorHepta Pharmaceuticals, Inc (“CorHepta”).
Current wording
Research and development expenses increased by $325,571, or 3.1%, to $10,839,150 from $10,513,579 in the prior comparable period. The prior period included a $7.4 million non-cash charge allocated to PAH related to the CorHepta transaction, which did not recur in the current period. Excluding the impact of this prior period charge, the increase in research and development was primarily driven by an increase in PAH costs. There was also a net increase of $1.2 million in other research and development partially offset by a decrease of $0.1 million in the risvodetinib (IkT-148009) program, which has been discontinued and out licensed.
Previous wording
Selling, general and administrative expenses increased by $3,973,900 or 242.7% to $5,611,503 from $1,637,603 in the prior comparable period. The $4.0 million increase was primarily driven by an increase of $0.8 million in personnel-related costs, $2.8 million in increased stock-based compensation expense and a $0.4 million increase in legal, consulting and compliance costs.
Current wording
Selling, general and administrative expenses increased by $2,126,832 or 40.5% to $7,376,123 from $5,249,291 in the prior comparable period. The $2.1 million increase was primarily driven by an increase of $0.4 million in personnel-related costs, $2.2 million increase in stock-based compensation expense, partially offset by a $0.5 million decrease in legal, consulting and compliance costs.
Previous wording
Change in fair value contingent consideration increased by $2,016,111 or 100% from $0 in the prior comparable period. The increase is due to the change in fair value of the contingent consideration related to the CorHepta transaction from the transaction date on February 21, 2025 to September 30, 2025.
Current wording
Change in fair value contingent consideration decreased by $791,510 or 67.9% to $373,354 from $1,164,864 in the prior comparable period. The decrease is a result of the change in fair value of the contingent consideration related to the CorHepta transaction from December 31, 2025 to February 21, 2026, the date the service milestone was satisfied.
Previous wording
Interest income increased by $788,683 or 1,596.2% to $838,093 from $49,410 in the prior comparable period. The increase was driven by interest earned on our cash, cash equivalents and marketable securities.
Current wording
Other income increased by $541,808 or 58.9% to $1,461,079 from $919,271 in the prior comparable period. The increase was driven by interest earned on our cash, cash equivalents and marketable securities.
Previous wording
From our inception up until our December 2020 initial public offering, we funded our operations primarily through private, state and federal contracts and grants. In October 2024, we raised approximately $99.6 million in net proceeds from our October 2024 Offering.
Current wording
From our inception up until our December 2020 initial public offering, we funded our operations primarily through private, state and federal contracts and grants. In October 2024, we raised approximately $99.6 million in net proceeds from a private placement and in November 2025, we raised approximately $107.6 million in net proceeds from our underwritten public offering.
Previous wording
On June 20, 2025, we entered into an Open Market Sale Agreement SM (the “Sales Agreement”) with Jefferies LLC, as sales agent ("Jefferies"), pursuant to which we may, from time to time, issue and sell shares of our common stock through or to Jefferies. Under the terms of the Sales Agreement, Jefferies may sell the shares of our common stock at market prices by any method that is deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act of 1933, as amended. As of September 30, 2025, no shares of our common stock have been sold under the Sales Agreement. As of September 30, 2025, we had $0.4 million of deferred offering costs related to the Sales Agreement.
Current wording
On June 20, 2025, we entered into an Open Market Sale Agreement SM (the “Sales Agreement”) with Jefferies LLC, as sales agent ("Jefferies"), pursuant to which we may, from time to time, issue and sell shares of our common stock through or to Jefferies. Under the terms of the Sales Agreement, Jefferies may sell the shares of our common stock at market prices by any method that is deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act of 1933, as amended. As of December 31, 2025, no shares of our common stock had been sold under the Sales Agreement. In February 2026, we sold 1,904,762 shares of common stock pursuant to the Sales Agreement for an aggregate gross sales price of $3.0 million.
Previous wording
At September 30, 2025, we had cash, cash equivalents and marketable securities of $77.3 million.
Current wording
At March 31, 2026, we had cash, cash equivalents and marketable securities of $170.4 million.
Previous wording
We have incurred recurring losses and at September 30, 2025 had an accumulated deficit of $129.9 million.
Current wording
We have incurred recurring losses and at March 31, 2026 had an accumulated deficit of $159.1 million.
Previous wording
Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, if ever, we expect to finance our incremental cash needs through a combination of equity offerings, debt financings, working capital lines of credit, grant funding and potential licenses and collaboration agreements. Additional working capital may not be available on commercially reasonable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, reduce or discontinue the development or commercialization of one or more of our product candidates. If we raise additional funds through the issuance of additional debt or equity securities, it could result in dilution to our existing stockholders, increased fixed payment obligations and the existence of securities with rights that may be senior to those of our common stock. If we incur indebtedness, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Additionally, any future collaborations we enter into with third parties may provide capital in the near term but limit our potential cash flow and revenue in the future. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
Current wording
Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, if ever, we expect to finance our incremental cash needs through a combination of equity offerings, debt financings, working capital lines of credit, and potential licenses and collaboration agreements. Additional working capital may not be available timely or on commercially reasonable terms, if at all. If we are unable to raise additional capital in sufficient amounts on a timely basis or on terms acceptable to us, we may have to significantly delay, reduce or discontinue the development or commercialization of one or more of our product candidates. If we raise additional funds through the issuance of additional debt or equity securities, it could result in dilution to our existing stockholders, increased fixed payment obligations and the existence of securities with rights that may be senior to those of our common stock. If we incur indebtedness, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Additionally, any future collaborations we enter into with third parties may provide capital in the near term but limit our potential cash flow and revenue in the future. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
Previous wording
Since our inception, we have incurred significant losses and negative cash flows from operations. We have an accumulated deficit of $129.9 million at September 30, 2025. We expect to incur substantial additional losses in the future as we conduct and expand our research and development activities.
Current wording
Since our inception, we have incurred significant losses and negative cash flows from operations. We have an accumulated deficit of $159.1 million at March 31, 2026. We expect to incur substantial additional losses in the future as we conduct and expand our research and development activities.
Previous wording
We expect to fund our operations through public equity or private equity or debt financings, as well as other sources. However, we may be unable to raise additional working capital, or if we are able to raise additional working capital, we may be unable to do so on commercially favorable terms. Our failure to raise capital or enter into such other arrangements if and when needed would have a negative impact on our business, results of operations and financial condition and our ability to continue to develop our product candidates.
Current wording
We expect to fund our operations through public equity or private equity or debt financings, as well as other sources. However, we may be unable to raise additional working capital, or if we are able to raise additional working capital, we may be unable to do so on a timely basis or commercially favorable terms. Our failure to raise capital or enter into such other arrangements if and when needed would have a negative impact on our business, results of operations and financial condition and our ability to continue to develop our product candidates.
Previous wording
the number and scope of preclinical and clinical programs we decide to pursue;
Current wording
the number and scope of preclinical and clinical programs we pursue;
Previous wording
Net cash flows used in operating activities for the nine months ended September 30, 2025, totaled $20,270,491, and consisted primarily of a net loss of $35.5 million adjusted for non-cash stock compensation of $10.8 million, a write-off of in-process research and development of $7.4 million, a decrease in the fair value of contingent consideration of $2.0 million, noncash accretion on marketable securities of $0.6 million, a decrease in accounts payable of $0.4 million, an increase in prepaid research and development of $1.1 million, an increase in accrued expenses and other current liabilities of $1.0 million and a decrease in other assets of $0.3 million and a decrease in other liabilities of $0.1 million.
Current wording
Net cash flows used in operating activities for the three months ended March 31, 2026, totaled $12,059,722, and consisted primarily of a net loss of $16.4 million adjusted for non-cash stock compensation of $5.6 million, a decrease in the fair value of contingent consideration of $0.4 million, non-cash accretion on marketable securities of $0.8 million, an increase in accounts payable and accrued expenses and other current liabilities of $0.5 million, an increase in prepaid expenses and other current assets of $0.9 million, a decrease in prepaid research and development of $0.5 million, and an increase in other assets of $0.1 million.
Previous wording
Net cash flows used in operating activities for the nine months ended September 30, 2024, totaled $13,802,492, and consisted primarily of a net loss of $15.4 million adjusted for non-cash stock compensation of $0.2 million, a decrease in prepaid research and development of $0.1 million, an increase in accounts payable of $1.3 million, and a decrease in accrued expenses and other current liabilities of $0.1 million.
Current wording
Net cash flows used in operating activities for the three months ended March 31, 2025, totaled $4,103,530, and consisted primarily of a net loss of $13.7 million adjusted for non-cash stock compensation of $2.0 million, a write-off of in-process research and development of $7.4 million, a decrease in the fair value of contingent consideration of $1.2 million, an increase in accounts payable of $0.7 million, and an increase in accrued expenses and other current liabilities of $0.8 million.
Previous wording
Cash Provided by (Used in) Financing Activities
Current wording
Cash Provided by (Used In) Investing Activities
Previous wording
Net cash flows provided by investing activities for the nine months ended September 30, 2024, totaled $1,757,524, of which $10.3 million was used for the purchase of marketable securities investments and $12.1 million was provided by maturity of marketable securities.
Current wording
Net cash flows used in investing activities for the three months ended March 31, 2026, totaled $80,484,587, of which $10.1 million was provided by maturity of marketable securities and $90.6 million was used for the purchase of marketable securities.
Previous wording
Net cash flows provided by investing activities for the nine months ended September 30, 2025, totaled $2,151,977, of which $41.6 million was provided by maturity of marketable securities, $39.0 million was used for the purchase of marketable securities and $0.4 million related to acquired in-process research and development associated with the CorHepta acquisition discussed above.
Current wording
Net cash flows provided by investing activities for the three months ended March 31, 2025, totaled $21,054,342, of which $21.5 million was provided by maturity of marketable securities offset by $0.4 million related to acquired in-process research and development associated with the CorHepta acquisition discussed above.
Previous wording
Net cash flows provided by financing activities for the nine months ended September 30, 2024, totaled $3,793,209, which consisted of $3.8 million of net proceeds from issuance of common stock and pre-funded warrants in connection with our May 2024 Offering and our ATM offering.
Current wording
Net cash flows provided by financing activities for the three months ended March 31, 2026, totaled $2,897,611, which consisted of net proceeds from the issuance of common stock in connection with the Sales Agreement with Jefferies.
Previous wording
Net cash flows used in financing activities for the nine months ended September 30, 2025, totaled $102,359, which consisted of $0.3 million of net proceeds from the issuance of common stock related to the exercise of stock options and $0.4 million of deferred offering costs in connection with the Open Market Sale Agreement SM (the “Sales Agreement”) with Jefferies LLC.
Current wording
Net cash flows provided by financing activities for the three months ended March 31, 2025, totaled $0.
Previous wording
We record research and development expenses to operations as incurred. Research and development expenses represent costs incurred by us for the discovery and development of our product candidates and the development of our RAMP™ drug discovery program and prodrug technologies and include: employee-related expenses, such as salaries, benefits, travel and non-cash stock-based compensation expense; external research and development expenses incurred under arrangements with third parties, such as CROs, preclinical testing organizations, clinical testing organizations, CMOs, academic and non-profit institutions and consultants; costs to acquire technologies to be used in research and development that have not reached technological feasibility and have no alternative future use; license fees; and other expenses, which include direct and allocated expenses for laboratory, facilities and other costs.
Current wording
We record research and development expenses to operations as incurred. Research and development expenses represent costs incurred by us for the discovery and development of our product candidates and prodrug technologies and include: employee-related expenses, such as salaries, benefits, travel and non-cash stock-based compensation expense; external research and development expenses incurred under arrangements with third parties, such as CROs, preclinical testing organizations, clinical testing organizations, CMOs, academic and non-profit institutions and consultants; costs to acquire technologies to be used in research and development that have not reached technological feasibility and have no alternative future use; license fees; and other expenses, which include direct and allocated expenses for laboratory, facilities and other costs.
Previous wording
As part of the process of preparing financial statements, we are required to estimate and accrue expenses. A portion of our research and development expenses is comprised of external costs, which we track on a program-specific basis. We record the estimated expenses of research and development activities conducted by third-party service providers as they are incurred and provided within research and development expense in the condensed consolidated statements of operations and comprehensive loss. These services include the conduct of clinical studies, preclinical studies and consulting services. These costs are a significant component of our research and development expenses. Typically, upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred, except for payments relating to intellectual property rights with future alternative use which will be expensed when the intellectual property is in use. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
Current wording
As part of the process of preparing the condensed consolidated financial statements, we are required to estimate and accrue expenses. A portion of our research and development expenses are external costs, which we track on a program-specific basis. We record the estimated expenses of research and development activities conducted by third party service providers as they are incurred and provided within research and development expense in the statements of operations. These services include the conduct of preclinical studies and consulting services. These costs are a significant component of our research and development expenses. Typically, upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred, except for payments relating to intellectual property rights with future alternative use which will be expensed when the intellectual property is in use. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
Previous wording
On February 21, 2025, we entered into an Agreement and Plan of Merger and Reorganization (“Merger Agreement”) with Project IKT Merger Sub, Inc., a Delaware corporation and our wholly-owned subsidiary (“Merger Sub”) and CorHepta Pharmaceuticals, Inc. a Delaware corporation (“CorHepta”). We determined that the transaction represented an asset acquisition as defined by ASC 805 as substantially all of the value was attributed to a single intangible asset, in-process research and development (“IPR&D”).
Current wording
On February 21, 2025, we entered into an Agreement and Plan of Merger and Reorganization (“Merger Agreement”) with Project IKT Merger Sub, Inc., a Delaware corporation and our wholly-owned subsidiary and CorHepta. We determined that the transaction represented an asset acquisition as defined by ASC 805 as substantially all of the value was attributed to a single intangible asset, in-process research and development (“IPR&D”).
Previous wording
The fair value was determined based on our share price at closing. We agreed to issue 4,979,101 shares of our common stock to the shareholders of CorHepta, of which (i) 829,849 shares were fully vested on the acquisition date, (ii) 2,489,030 shares represented contingent consideration and will vest no later than February 21, 2026, subject to the achievement of certain milestones, and (iii) 1,660,222 shares represented post-merger compensation expense, subject to both service- and performance-based vesting conditions.
Current wording
The fair value was determined based on our share price at closing. We agreed to issue 4,979,101 shares of our common stock to the shareholders of CorHepta, of which (i) 829,849 shares were fully vested on the acquisition date, (ii) 2,489,030 shares represented contingent consideration and vested on February 21, 2026, upon the achievement of a service milestone, and (iii) 1,660,222 shares represented post-merger compensation expense, subject to both service- and performance-based vesting conditions, which were not met and, as a result, these shares were forfeited on February 21, 2026. Upon determination that the service milestone was satisfied in relation to (ii) above, the liability was settled through the issuance of common stock and reclassified to additional paid-in capital on February 21, 2026. No other agreements with contingent consideration currently exist.
Previous wording
As of the acquisition date, the achievement of one of the contingent consideration milestones was deemed probable, and the fair value of the related shares was included in the purchase price of the acquisition. We remeasure the initial contingent consideration recognized at acquisition to fair value at each reporting date and recorded a change in fair value of $492,827 and $2,016,111 for the three and nine month period ended September 30, 2025, which is included within operating expenses. We will recognize a contingent consideration liability and corresponding expense for the remaining contingent consideration shares in future periods when it is probable that a liability has been incurred and the amount of that liability can be reasonably estimated. As of September 30, 2025, the remaining performance-based vesting conditions are not probable and cannot be estimated.
Current wording
As of the acquisition date, the achievement of one of the contingent consideration milestones was deemed probable, and the fair value of the related shares was included in the purchase price of the acquisition. We remeasure the initial contingent consideration recognized at acquisition to fair value at each reporting date and recorded a change in fair value of $373,354 for the three-month period ended March 31, 2026, which is included within operating expenses. We recognized a contingent consideration liability and corresponding expense for the remaining contingent consideration shares in future periods when it was probable that a liability had been incurred and the amount of that liability could be reasonably estimated.
Previous wording
The IPR&D had not reached technological feasibility and had no alternative future use at the acquisition date, and therefore, the acquired IPR&D asset of $7,357,294 was written-off as research and development expense in our condensed consolidated statements of operations and comprehensive loss immediately following the acquisition in accordance with ASC 730.
Current wording
The IPR&D had not reached technological feasibility and had no alternative future use at the acquisition date, and therefore, the acquired IPR&D asset of $7,357,294 was written-off as research and development expense in our consolidated statements of operations and comprehensive loss immediately following the acquisition in accordance with ASC 730.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
Comparison of the Nine Months Ended September 30, 2025 and 2024.
Previous report — wording carried elsewhere
The following table sets forth the significant components of our results of operations:
Previous report — wording carried elsewhere
Change in Fair Value Contingent Consideration
Previous report — wording carried elsewhere
Interest income increased by $2,401,060 or 879.3% to $2,674,119 from $273,059 in the prior comparable period. The increase was driven by interest earned on our cash, cash equivalents and marketable securities.