Research and Development - Lexaria incurred $1,640,648 in R&D expenditures for the quarter ended May 31, 2023, compared to $752,095 in May 2022, indicating a significant increase in investment in research activities [80]. - The FDA has agreed to Lexaria's proposal to pursue a 505(b)(2) new drug application regulatory pathway for DehydraTECH-CBD for the treatment of hypertension, with an IND filing anticipated in late fiscal 2023 or early 2024 [81]. - The initial results from the hypertension study HYPER-H21-4 showed a sustained drop in blood pressure in normally active hypertensive patients following multiple weeks of oral CBD therapy [83]. - DehydraTECH-CBD demonstrated increased blood absorption levels compared to published pharmaceutical-grade CBD industry peers, suggesting superior efficacy in blood pressure reduction [86]. - The DehydraTECH-estradiol formulation achieved an average peak concentration in the bloodstream of 5.65 ng/mL, approximately 900% higher than the control formulation [93]. - Lexaria's patent portfolio includes 34 granted patents and ongoing applications in over 40 countries, which could lead to material increases in shareholder value [75]. - The company completed three human studies on hypertension in fiscal 2022, with results from the fourth study published in six research articles [72]. - Lexaria is advancing several R&D activities, including investigations of CBD for diabetes and dementia, with positive outcomes reported in animal studies [91]. - The company continues to engage in small R&D projects and B2B formulation for third parties evaluating DehydraTECH technology for their products [73]. - Lexaria's patented DehydraTECH technology improves the delivery of bioactive compounds, enhancing the effectiveness of various active pharmaceutical ingredients [70]. - The company anticipates increased expenditures related to ongoing R&D programs, particularly for clinical trials of DehydraTECH formulations [99]. Financial Performance - The company reported a net loss of $5,463,510 for the nine months ended May 31, 2023, compared to a net loss of $5,870,492 for the same period in 2022, reflecting a decrease of $406,982 [100][106]. - Revenues increased to $229,641 for the nine months ended May 31, 2023, up from $144,247 in 2022, marking an increase of $85,394 [105][107]. - Research and development expenditures rose significantly by $1,679,828 year-over-year, totaling $3,166,315 for the nine months ended May 31, 2023 [105][108]. - Cash flows used in operating activities increased to $4,259,557 for the nine months ended May 31, 2023, compared to $3,702,724 in 2022 [112][113]. - The company entered into a $2 million financing agreement resulting in the issuance of 2,106,000 common shares and warrants [119]. - The company has no off-balance sheet arrangements that could materially affect its financial condition [96]. - The company has evaluated its ability to continue as a going concern and has cash on hand of approximately $3,163,906 to settle current liabilities [121]. Future Expectations - The anticipated results from the human clinical nicotine study NIC-H22-1 are expected to be released in the fourth quarter of 2023 [95]. - As of May 31, 2023, the company had current assets of $4,235,490 and current liabilities of $1,055,904, resulting in net working capital of $3,179,586 [112][121].
Lexaria Bioscience(LEXX) - 2023 Q3 - Quarterly Report