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Inhibikase Therapeutics(IKT) - 2025 Q1 - Quarterly Report
IKTInhibikase Therapeutics(IKT)2025-05-14 21:29

Product Development - The company is developing IKT-001, a prodrug of imatinib mesylate, for the treatment of Pulmonary Arterial Hypertension (PAH), with a Phase 2b study expected to start in the second half of 2025[114]. - A bioequivalence study established that a 300 mg dose of IKT-001 is equivalent to 230 mg of imatinib mesylate, and a 500 mg dose is equivalent to 383 mg of imatinib mesylate[116]. - The company has commercialization rights to IKT-001 with patent protection in the U.S. until 2033, with potential extensions until 2045[124]. - The FDA has indicated that the 505(b)(2) pathway is appropriate for the approval of IKT-001, which may grant New Molecular Entity status and market exclusivity[122]. - A recent study confirmed that imatinib was well tolerated in PAH patients, supporting the efficacy of IKT-001[123]. - The company plans to apply for Orphan Drug Designation for IKT-001 once pre-clinical studies are complete[122]. Financial Performance - Research and development expenses for the first quarter of 2025 totaled 10.51million,asignificantincreasefrom10.51 million, a significant increase from 2.75 million in the same period of 2024[131]. - Research and development expenses increased by 7,762,300or282.17,762,300 or 282.1% to 10,513,579 from 2,751,279inthepriorcomparableperiod[135].−Selling,generalandadministrativeexpensesroseby2,751,279 in the prior comparable period[135]. - Selling, general and administrative expenses rose by 3,218,210 or 158.4% to 5,249,291from5,249,291 from 2,031,081 in the prior comparable period[136]. - Net loss for the three months ended March 31, 2025, was 13,678,735,comparedtoanetlossof13,678,735, compared to a net loss of 4,649,635 in the prior comparable period, representing an increase of 194.2%[134]. - Interest income surged by 786,546or592.6786,546 or 592.6% to 919,271 from 132,725inthepriorcomparableperiod[138].−AsofMarch31,2025,thecompanyhadcash,cashequivalents,andmarketablesecuritiestotaling132,725 in the prior comparable period[138]. - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling 93,180,291[140]. - The company incurred net cash used in operating activities of 4,103,530forthethreemonthsendedMarch31,2025,comparedto4,103,530 for the three months ended March 31, 2025, compared to 3,867,018 for the same period in 2024[148]. - Net cash provided by investing activities for the three months ended March 31, 2025, was 21,054,342,significantlyhigherthan21,054,342, significantly higher than 3,311,814 in the prior comparable period[152]. - The company has an accumulated deficit of 108,099,346asofMarch31,2025[141].FundingandFutureOutlook−Thecompanyraisedapproximately108,099,346 as of March 31, 2025[141]. Funding and Future Outlook - The company raised approximately 110 million in a private placement to support the Phase 2b trial for IKT-001, with potential total gross proceeds of up to 275millionifwarrantsareexercised[122].−Futurefundingrequirementsareanticipatedtobesubstantialasthecompanycontinuestodevelopandseekregulatoryapprovalsforitsproductcandidates[142].−Thecompanyexpectstofinanceitscashneedsthroughacombinationofequityofferings,debtfinancings,andpotentialcollaborationagreements[143].CorporateActions−ThecompanyhasdiscontinuedthedevelopmentofrisvodetinibforParkinson′sdiseaseandhasoutlicensedtheprogram[115].−Thecompanyagreedtoissue4,979,101sharesofcommonstocktoCorHeptashareholders,with829,849sharesfullyvestedatacquisition,2,489,030sharesascontingentconsideration,and1,660,222sharesforpost−mergercompensation[163].−Achangeinfairvalueofcontingentconsiderationof275 million if warrants are exercised[122]. - Future funding requirements are anticipated to be substantial as the company continues to develop and seek regulatory approvals for its product candidates[142]. - The company expects to finance its cash needs through a combination of equity offerings, debt financings, and potential collaboration agreements[143]. Corporate Actions - The company has discontinued the development of risvodetinib for Parkinson's disease and has outlicensed the program[115]. - The company agreed to issue 4,979,101 shares of common stock to CorHepta shareholders, with 829,849 shares fully vested at acquisition, 2,489,030 shares as contingent consideration, and 1,660,222 shares for post-merger compensation[163]. - A change in fair value of contingent consideration of 1,164,864 was recorded for the period ended March 31, 2025, included within operating expenses[164]. - The acquired IPR&D asset of $7,357,294 was written off as research and development expense immediately following the acquisition[165].