Company Overview - The company is a clinical-stage pharmaceutical company focused on developing protein kinase inhibitor therapeutics for Parkinson's disease and related disorders[86]. Clinical Trials and Development - The Phase 2 trial for Risvodetinib (IkT-148009) was fully enrolled with 32 sites open as of June 17, 2024, and results are expected to be reported in Q4 2024[87]. - In the 201 trial, participants on the 200 mg dose showed an average improvement of -10.4 points on the MDS-UPDRS scale compared to placebo, indicating potential clinical benefit[88]. - Risvodetinib (IkT-148009) has been granted Orphan Drug Designation by the FDA for the treatment of MSA, and a Phase 2/3 program is being planned[89]. - The FDA lifted clinical holds on Risvodetinib (IkT-148009) programs for Parkinson's disease and MSA, but future holds may still occur[80]. - IkT-001Pro has established bioequivalence to 400 mg imatinib mesylate with a 600 mg dose, and a preferred dose of 800 mg to 900 mg is being evaluated for equivalence to 600 mg imatinib mesylate[90]. - The FDA indicated that the 505(b)(2) pathway is appropriate for IkT-001Pro's approval, with clinical studies showing similar exposures for 600 mg and 800 mg IkT-001Pro compared to 400 mg and 600 mg imatinib mesylate, respectively[91]. - The company plans to evaluate IkT-001Pro at 300 mg or 450 mg in a Phase 2/3 trial for PAH, with the FDA confirming it would be viewed as a New Molecular Entity (NME)[93]. - A new tablet formulation of Risvodetinib (IkT-148009) has nearly doubled the concentration delivered compared to the previous gelatin capsule, potentially improving safety and tolerability[94]. Financial Performance - The company has incurred significant net losses since inception and anticipates continuing to incur losses for the foreseeable future[81]. - The company has a material weakness in internal control over financial reporting as of June 30, 2024, which could impact financial results[82]. - The clinical development process is lengthy and expensive, with significant risks and uncertainties that could affect the company's future viability[80]. - Research and development expenses for the six months ended June 30, 2024, totaled $5,827,109, a decrease of $1,562,708 compared to $7,389,817 in the same period of 2023[103]. - Direct research and development expenses for Parkinson's disease (PD) increased by $172,770 to $2,666,108 in 2024, while expenses for Chronic Myelogenous Leukemia (CML) decreased by $1,449,554 to $44,403[105]. - Grant revenue for the three months ended June 30, 2024, decreased by $116,410 or 100.0% to $0 from $116,410 in the prior comparable period[109]. - Research and development expenses decreased by $1,459,868 or 32.2% to $3,075,830 from $4,535,698 in the prior comparable period[110]. - Selling, general and administrative expenses increased by $191,592 or 10.7% to $1,974,705 from $1,783,113 in the prior comparable period[111]. - Interest income decreased by $333,508 or 78.6% to $90,927 from $424,435 in the prior comparable period[112]. - The company had working capital of $4,898,258 and an accumulated deficit of $76,509,968 as of June 30, 2024[119]. - The company expects to incur significant losses for the foreseeable future as it continues the development of its product candidates[120]. - The company raised approximately $3.2 million in net proceeds from its May 2024 Offering[117]. - Net cash used in operating activities for 2024 was $8,921,392 compared to $10,537,519 in 2023[128]. - As of June 30, 2024, the company had cash and cash equivalents of $3,086,455 and marketable securities of $4,853,559[119]. - Net cash flows used in operating activities for the six months ended June 30, 2024, totaled $8,921,392, compared to $10,537,519 for the same period in 2023, reflecting a decrease of approximately 15.4%[129]. - Net cash flows used in investing activities for the six months ended June 30, 2024, totaled $768,587, significantly lower than $3,288,963 for the same period in 2023, indicating a decrease of about 76.7%[130][131]. - Net cash flows provided by financing activities for the six months ended June 30, 2024, totaled $3,611,255, a decrease of approximately 57.7% compared to $8,543,037 for the same period in 2023[132]. - The company has a total lease obligation of $190,546, with minimum annual rental obligations of $75,580 for fiscal year 2024 and $114,966 for fiscal year 2025[134]. - The company reported a net loss of $9.6 million for the six months ended June 30, 2024, compared to a net loss of $10.3 million for the same period in 2023, showing an improvement of approximately 6.8%[129]. - The company has not entered into any off-balance sheet arrangements, indicating a straightforward financial structure[133]. Strategic Partnerships and Intellectual Property - The company is highly dependent on the success of its initial product candidates targeting neurodegenerative diseases, with no products currently approved for commercial sale[81]. - The company has commercialization rights for all development programs, with patent protection for IkT-001Pro until 2033 and for Risvodetinib until 2036[96]. - As of August 1, 2024, the patent portfolio includes nine issued patents and four pending applications in the U.S., with expiration dates between 2033 and 2037[97]. - The company is in active discussions with potential strategic partners for the IkT-001Pro program and has applied for Orphan Drug Designation for its use in PAH[93]. Legal and Compliance - The company is currently involved in a legal dispute with Pivot Holding LLC, seeking $1.625 million in milestone payments, which the company disputes as without merit[144]. - The company has strengthened internal controls in response to a material weakness identified in its financial reporting processes[141]. - Research and development expenses are recorded as incurred, reflecting the company's ongoing commitment to product development and innovation[136]. - The company has made significant judgments and estimates in determining accrued research and development expenses, which are subject to change based on actual costs incurred[138].
Inhibikase Therapeutics(IKT) - 2024 Q2 - Quarterly Report