IkT-001Pro Development and Clinical Trials - The company completed a bioequivalence clinical trial for IkT-001Pro in 2023, establishing bioequivalence to 400 mg imatinib mesylate with a 600 mg dose of IkT-001Pro[78] - A dose between 800 mg and 900 mg of IkT-001Pro is preferred to deliver a dose equivalent to 600 mg imatinib mesylate[78] - The FDA acknowledged the 505(b)(2) pathway as appropriate for IkT-001Pro approval, pending formal review of clinical data[78] - IkT-001Pro and imatinib mesylate exhibit similar behavior toward gut transporters P-glycoprotein (PGP) and Breast Cancer Resistance Protein (BCRP)[79] - The company discussed alternate dosage forms for IkT-001Pro to prevent medication errors with imatinib mesylate[79] - The company met with the FDA Hematological Malignancy Review Team on January 19, 2024, to discuss IkT-001Pro's path to approval[78] - The company's multi-therapeutic pipeline includes IkT-001Pro for Pulmonary Arterial Hypertension (PAH)[77] - The company has patent protection in the United States until 2033 for IkT-001Pro[87] Risvodetinib Development and Clinical Trials - The company initiated Phase 2 201 trial for risvodetinib (IkT-148009) as a treatment for Parkinson's disease, with results expected in Q4 2024[77] - The company completed the Phase 2 201 trial for risvodetinib on October 6, 2024[77] - The Phase 2 '201 Trial' for risvodetinib in untreated Parkinson's disease was completed on October 6, 2024, with outcomes expected in Q4 2024[81] - The Company received a $0.39 million grant from the National Institute of Neurological Diseases and Stroke for risvodetinib studies in MSA[82] - The tablet formulation of risvodetinib nearly doubles the concentration delivered, potentially improving safety and tolerability[84] - The company's multi-therapeutic pipeline includes risvodetinib for Parkinson's disease[77] - The Company plans to submit regulatory documents for risvodetinib to European Union authorities in 2024 or 2025[82] - The company has patent protection in the United States until 2036 for risvodetinib[87] Financial Performance and Expenses - The Company closed a private placement with an initial investment of approximately $110 million, potentially reaching up to $275 million if warrants are exercised[80] - Research and development expenses for PAH increased by $814,424 in 2024 compared to 2023[95] - Total research and development expenses for the three months ended September 30, 2024, were $4,189,873, a 29.9% increase from 2023[100] - The Company's net loss for the three months ended September 30, 2024, was $5,778,066, a 25.7% increase from 2023[100] - Grant revenue for the three months ended September 30, 2024, decreased by $79,569 or 100.0% to $0 from $79,569 in the prior comparable period[101] - Research and development expenses increased by $964,322 or 29.9% to $4,189,873 from $3,225,551 in the prior comparable period[102] - Selling, general and administrative expenses increased by $14,709 or 0.9% to $1,637,603 from $1,622,894 in the prior comparable period[103] - Interest income decreased by $124,267 or 71.6% to $49,410 from $173,677 in the prior comparable period[104] - Grant revenue for the nine months ended September 30, 2024, decreased by $260,500 or 100% to $0 from $260,500 in the prior comparable period[106] - Research and development expenses decreased by $598,386 or 5.6% to $10,016,982 from $10,615,368 in the prior comparable period[107] - Selling, general and administrative expenses increased by $312,028 or 5.9% to $5,643,386 from $5,331,358 in the prior comparable period[108] - Interest income decreased by $562,224 or 67.3% to $273,059 from $835,283 in the prior comparable period[109] - The Company raised approximately $110 million in gross proceeds from its October 2024 Offering[110] - Net cash flows used in operating activities for the nine months ended September 30, 2024, totaled $13,802,492[117] - Net cash flows provided by financing activities for the nine months ended September 30, 2024, totaled $3.793 billion, consisting of $3.8 million from the issuance of common stock and pre-funded warrants[121] - Net cash flows provided by financing activities for the nine months ended September 30, 2023, totaled $8.543 billion, primarily from the issuance of common stock and pre-funded warrants[122] Market and Industry Insights - The global PAH market size was valued at $7.66 billion in 2023 and is estimated to grow at a CAGR of 5.4% between 2024 to 2030[80] - The company's clinical trials and product development are focused on neurodegenerative and cardiopulmonary diseases[77] Operational and Financial Details - The company's total lease obligation for its Lexington office space is $153,288, with minimum annual rental obligations of $38,322 for fiscal year 2024 and $114,966 for fiscal year 2025[123] - Research and development expenses include costs for employee-related expenses, external R&D arrangements, technology acquisition, and other direct and allocated expenses[125] - A significant portion of R&D expenses is attributed to external costs, including clinical studies, preclinical studies, and consulting services[126] - The company accrues and estimates R&D expenses based on costs incurred, with adjustments made as actual costs become known[127] - The company does not have any off-balance sheet arrangements[123] - Financial statements are prepared in accordance with US GAAP, requiring significant estimates and judgments that may impact reported amounts[124] - The company is not required to provide quantitative and qualitative market risk disclosures as a smaller reporting company[129]
Inhibikase Therapeutics(IKT) - 2024 Q3 - Quarterly Report