Cellect(US:QNRX)2025-11-06 21:30Clinical Development - QRX003 is in pivotal registrational clinical studies for Netherton Syndrome, with six clinical sites opened in the US and trials expanded internationally to the Middle East, UK, Spain, and Germany[92]. - The FDA granted Orphan Drug Designation to QRX003 for Netherton Syndrome, providing benefits such as tax credits and seven years of market exclusivity upon approval[103]. - The company has entered into nine commercial partnerships for QRX003 across 61 countries outside its core territories, enhancing market expansion efforts[92]. - The company anticipates significant future research and development expenses as it prepares for regulatory approval of QRX003 and other product candidates[106]. - The company incurred approximately $522,000 in research and development expenses under agreements related to QRX003 for the three months ended September 30, 2025[132]. Financial Performance - Total operating expenses for Q3 2025 were approximately $4.02 million, an increase of $1.49 million, or 59%, compared to $2.53 million in Q3 2024[111]. - Research and development expenses increased by approximately 111% to $2.28 million in Q3 2025 from $1.08 million in Q3 2024, primarily due to increased external expenditures on development programs[113]. - General and administrative expenses rose by approximately 20% to $1.74 million in Q3 2025 from $1.45 million in Q3 2024, driven by higher payroll and benefits costs[112]. - Total operating expenses for the nine months ended September 30, 2025, were approximately $11,770,281, an increase of $4,646,877, or approximately 65% compared to $7,123,404 in 2024[116]. - Research and development expenses increased by $4,154,000, or approximately 163%, totaling $6,706,000 for the nine months ended September 30, 2025, compared to $2,552,000 in 2024[118]. - The net loss for the nine months ended September 30, 2025, was approximately $11,456,282, an increase of $4,805,084 compared to a net loss of $6,651,198 in 2024[116]. - Cash and cash equivalents totaled approximately $1.8 million, with investments of $3.6 million as of September 30, 2025[121]. - Net cash used in operating activities was approximately $8,506,000 for the nine months ended September 30, 2025, compared to $5,621,000 in 2024, reflecting an increase in net loss[127]. - The company has an accumulated deficit of approximately $66.6 million as of September 30, 2025[121]. Funding and Capital Structure - The company received approximately $15 million in net proceeds from a private placement on October 14, 2025, intended for general corporate purposes, including R&D for QRX003[97]. - The company entered into a Securities Purchase Agreement for gross proceeds of approximately $16.6 million on October 10, 2025, to support its operations[121]. - The authorized capital was increased from 100 million to 5 billion ordinary shares, approved at the 2025 Annual General Meeting[95]. - The company plans to fund up to approximately €567,000 ($665,000) for a research program at UCC over an anticipated 2.5-year period[134]. - The company may need to obtain further funding through public or private offerings, debt financing, or collaboration arrangements to support its operations and development efforts[122]. Strategic Plans - The company plans to establish its own sales infrastructure in the US, Europe, and Japan while pursuing distribution partnerships in other territories[94].