Core Insights - Lexaria Bioscience Corp. has entered into a Material Transfer Agreement (MTA) with a pharmaceutical company to evaluate its DehydraTECH technology in pre-clinical studies [1][2] - Initial pre-clinical studies have been completed, focusing on pharmacokinetics in animals, but results will not be disclosed [2] - Lexaria is preparing for strategic discussions with the pharmaceutical company's clinical development team regarding potential human clinical studies [3] Company Overview - Lexaria's DehydraTECH is a patented drug delivery platform that enhances the absorption of various drugs through oral delivery, aiming to improve bio-absorption and reduce side effects [4] - The company holds a strong intellectual property portfolio with 48 patents granted and additional patents pending globally [4]

Core Viewpoint - Lexaria Bioscience Corp. successfully closed a registered direct offering, raising $2.0 million by selling 2,000,000 shares at $1.00 each, minimizing dilution for existing shareholders by avoiding the issuance of new warrants, except for pre-funded warrants [1][2][3]. Group 1: Offering Details - The offering involved a single institutional investor purchasing 2,000,000 shares of common stock or pre-funded warrants at a price of $1.00 per share [1]. - The gross proceeds from the offering were $2.0 million before deducting placement agent fees and other expenses [3]. - H.C. Wainwright & Co. acted as the exclusive placement agent for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for working capital and other general corporate purposes [3]. Group 3: Company Background - Lexaria operates a patented drug delivery platform, DehydraTECH™, which enhances the absorption of various drugs through oral delivery [6]. - The company holds a robust intellectual property portfolio with 48 patents granted and additional patents pending worldwide [6].

Technology and Product Development - Lexaria's DehydraTECH technology improves the delivery of Active Pharmaceutical Ingredients (API), enhancing bioavailability and potentially lowering overall dosing[107] - In a recent study, DehydraTECH-enhanced liraglutide and certain CBD formulations outperformed Rybelsus® in lowering blood sugar and controlling body weight[109] - The company reported a 47% reduction in adverse events for DehydraTECH-tirzepatide compared to Zepbound®, with comparable blood glucose and insulin level reductions[111] - The company initiated a Phase 1b clinical study in Australia for DehydraTECH Cannabidiol in combination with GLP-1 agonists for diabetes treatment[114] - An Ethics Board approved a new pilot study investigating an oral version of liraglutide using DehydraTECH, aiming to demonstrate safety and pharmacokinetic performance[115] - Lexaria's patent portfolio includes applications for DehydraTECH with cannabinoids for treating heart disease and hypertension, as well as for diabetes and weight loss[118] - Lexaria's primary clinical research areas include DehydraTECH-powered GLP-1/GIP drugs and CBD for diabetes and hypertension treatment[123] Financial Performance - Lexaria reported a net loss of $5,423,600 for the six months ended February 28, 2025, compared to a net loss of $1,837,771 for the same period in 2024, reflecting an increase of $3,585,829[139] - Revenues increased to $357,923 for the six months ended February 28, 2025, up from $296,278 in the prior year, with licensing fees and B2B sales rising by $58,010 and $4,535, respectively[140] - Research and development expenditures surged by $2,818,866 year-over-year, primarily due to the advancement of GLP-1 studies and the manufacturing of Investigational Drug Product[141] - Consulting fees and salaries rose by $572,909, attributed to the transition of the former CEO and the hiring of a new CEO and CFO[142] - Legal and professional fees increased by $25,154 due to higher accounting and professional service costs associated with registration filings[143] - General and administrative expenses grew by $281,390, driven by increased advertising costs and foreign currency transaction losses[144] - Cash flows used in operating activities were approximately $4.2 million for the six months ended February 28, 2025, compared to $1.8 million in the prior year[146] - The company raised $4.4 million in net proceeds from securities sales during the six months ended February 28, 2025, down from $5.3 million in the same period in 2024[149] Financial Position and Concerns - As of February 28, 2025, the company had a working capital of $5,901,986, down from $6,798,567 as of August 31, 2024[145] - The company has an accumulated deficit of $57.0 million as of February 28, 2025, and expects to continue incurring significant operational expenses and net losses in the upcoming 12 months[150] - As of February 28, 2025, the company had cash and cash equivalents of approximately $6.5 million to settle $1.8 million in current liabilities[153] - The company has substantial doubt regarding its ability to continue as a going concern for at least one year following the date of the financial statements[153] - The company intends to fund operations and working capital for the twelve-month period following February 28, 2025 through equity financing arrangements and potential collaborations or strategic partnerships[153] - There is no assurance that the company will have sufficient funds to execute its intended business plan or generate positive operating results[154] - The consolidated financial statements do not include any adjustments related to the uncertainty of the company's ability to continue as a going concern[155]

Core Viewpoint - Lexaria Bioscience Corp. announced positive pharmacokinetic results from its Human Study 3, demonstrating that its oral DehydraTECH-tirzepatide can achieve comparable blood concentration levels to the injected Zepbound® [1][2][10] Study Design and Results - The study involved 10 participants receiving a weekly injection of Zepbound® and 9 participants taking DehydraTECH-tirzepatide capsules daily over the same period [3] - Peak blood levels for injected Zepbound® were generally higher but showed a decline after Day 2, while DehydraTECH-tirzepatide levels increased steadily and were still rising on Day 8 [4][5] - 80% of injected participants experienced peak levels on Day 2, whereas 50% of DehydraTECH-tirzepatide participants peaked on the final day, indicating ongoing absorption [4] Side Effects and Efficacy - DehydraTECH-tirzepatide showed a 47% reduction in adverse events compared to injected Zepbound®, with only 20 adverse events reported for the oral version versus 38 for the injection [5][6] - Gastrointestinal side effects were reduced by 54% with DehydraTECH-tirzepatide, while glycemic performance indicators remained comparable between the two formulations [6] Future Studies - The company is conducting a 12-week study in Australia to further evaluate the effectiveness of DehydraTECH-tirzepatide, with dosing starting at 20 mg/day and escalating to 40 mg/day [7][8] - The ongoing study aims to assess steady-state blood levels over an extended duration, which could position Lexaria as a significant player in the GLP-1 weight loss and diabetes control markets [7][8] Competitive Landscape - Currently, there is no oral version of tirzepatide available, as it is only sold as an injection [9][12] - Lexaria's DehydraTECH technology has previously shown promise in delivering other GLP-1 drugs, indicating potential for a competitive oral alternative in the market [11][12]

Core Insights - Lexaria Bioscience Corp. is pursuing the development of the world's first orally-dosed liraglutide using its DehydraTECH technology, which enhances drug delivery [1][2] - The company has filed patent applications for this new formulation, aiming to capitalize on the recent off-patent status of liraglutide [2] - Positive results from animal studies indicate that DehydraTECH-liraglutide outperformed existing oral treatments in controlling blood sugar and body weight [3] - Lexaria is also preparing for human clinical trials to further validate the efficacy and safety of its oral liraglutide formulation [5][6] Company Strategy - Lexaria's strategy includes simultaneous research on leading GLP-1/GIP drugs, with a market potential estimated at $30 billion in 2024, a significant increase from $300 million in 2018 [4] - The company aims to expedite its entry into the GLP-1 market by initiating pilot clinical testing of DehydraTECH-liraglutide [5] - If successful, the company plans to pursue regulatory approval from the FDA for its orally-dosed liraglutide, potentially in collaboration with Novo Nordisk, the original developer of liraglutide [6] Market Context - Currently, liraglutide is only available in injectable forms, generating substantial revenue for Novo Nordisk, with $849 million from Saxenda and $1.6 billion from Victoza in the first half of 2024 [7] - The introduction of an oral version could disrupt the market and provide a competitive edge for Lexaria, especially given the lack of existing oral formulations [2][7] - Liraglutide has shown additional benefits beyond diabetes management, including cognitive decline reduction, which may enhance its market appeal [8] Technology Overview - DehydraTECH is a patented drug delivery technology that improves the absorption of active pharmaceutical ingredients through oral administration [9] - The technology has demonstrated the ability to enhance bio-absorption and effectively deliver drugs across the blood-brain barrier [9] - Lexaria holds a robust intellectual property portfolio with 48 patents granted and additional patents pending, positioning it well for future innovations [9]

Technology and Research - Lexaria's DehydraTECH technology enhances the delivery of Active Pharmaceutical Ingredients (APIs), improving bioavailability and potentially lowering overall dosing[98] - During the three months ended November 30, 2024, Lexaria completed a GLP-1 Diabetes Animal Study with 72 diabetic rats, showing that DehydraTECH-enhanced formulations outperformed Rybelsus® in lowering blood sugar and controlling body weight[99] - Lexaria's Phase 1b study in Australia will involve 80 overweight or obese patients to investigate the efficacy of DehydraTECH-CBD and DehydraTECH-enhanced semaglutide compared to Rybelsus®[103] - The company is advancing R&D activities in both preclinical and clinical programs, focusing on DehydraTECH-powered GLP-1/GIP drugs and CBD for diabetes and hypertension[115] - Lexaria completed dosing for a human pilot study involving nine healthy volunteers, investigating DehydraTECH-tirzepatide capsules with no serious adverse events reported[116] - The company has received Ethics Board Approval for its Australian clinical study on DehydraTECH Cannabidiol and GLP-1 agonists[107] - Lexaria's patent portfolio includes applications for the use of DehydraTECH with cannabinoids for treating heart disease, hypertension, epilepsy, and diabetes[110] - The company entered into a Project Agreement with Novotech for conducting its Australian clinical study on DehydraTECH Cannabidiol[107] - Lexaria's ongoing studies include a comprehensive analysis of liver and kidney function and blood chemistry related to its recent animal studies[100] - DehydraTECH-liraglutide and DehydraTECH-CBD formulations showed body weight loss of 11.53% and 10.65%, and blood sugar reduction of 11.13% and 3.35%, outperforming the Rybelsus® control group[118] - Lexaria plans a Phase 1b study in Australia with 80 overweight or diabetic patients to evaluate the efficacy of DehydraTECH formulations[119] Financial Performance - Net loss for the three months ended November 30, 2024, was $2,706,628, compared to $1,185,038 for the same period in 2023, reflecting an increase of $1,521,590[134] - Revenue for the three months ended November 30, 2024, was $183,923, an increase of $32,645 from $151,278 in the same period last year[134] - Research and development expenditures increased by $1,378,729 year-over-year, primarily due to the manufacturing of the Investigational Drug Product for the Phase 1b Clinical Trial[136] - The company raised $4.3 million in net proceeds from the sale of securities during the three months ended November 30, 2024[132] - Current assets as of November 30, 2024, were $8,825,741, with current liabilities of $297,798, resulting in net working capital of $8,527,943[140] - Cash flows used in operating activities were approximately $2.73 million for the three months ended November 30, 2024, compared to $1.18 million in the same period in 2023[141] - The company anticipates increased expenditures related to ongoing R&D programs and expects to incur operating losses and negative cash flows for the foreseeable future[129] - As of November 30, 2024, the company had an accumulated deficit of $54.26 million, raising substantial doubt about its ability to continue as a going concern[143] Share Issuance and Control - The company issued 1,633,987 shares at $3.06 per share, raising gross proceeds of $5.0 million and net proceeds of $4.5 million during the same period[105] - On October 16, 2024, the Company issued 1,633,987 shares of common stock at a price of $3.06 per share, resulting in gross proceeds of $5.0 million and net proceeds of $4.5 million[147] - The Company concurrently issued 4,551,019 share purchase warrants, allowing the holder to purchase shares at $3.06 per share for five years[147] - In October 2024, the Company sold 8,402 shares through an At the Market (ATM) offering, generating gross proceeds of $26,146[147] - As of November 30, 2024, the Company's disclosure controls and procedures were deemed effective at a reasonable assurance level[148] - There were no changes in internal controls over financial reporting during the quarter ended November 30, 2024, that materially affected the controls[150] - The Company is not involved in any material legal proceedings against itself or its subsidiaries[151]

Clinical Trials and Research - Lexaria's final results from its human pilot study indicated that DehydraTECH-enhanced Rybelsus™ achieved sustained higher levels of semaglutide in blood, faster peak drug delivery, reduced side effects, and lower blood glucose levels after eating [111]. - The company filed an Investigational New Drug (IND) application with the FDA for a phase 1b hypertension clinical trial for its DehydraTECH-CBD drug product, receiving a Study May Proceed letter on February 29, 2024 [112]. - Interim findings from a study on DehydraTECH-semaglutide showed sustained higher levels of semaglutide in blood and reduced side effects, with final results confirming these benefits [120]. - A human pilot study for DehydraTECH-semaglutide has commenced, with the first two dosing arms completed, focusing on tolerability and blood sugar control [142]. - The company plans to initiate a chronic human study in Q3 2024, involving 60 to 80 obese, pre-diabetic, and/or type-2 diabetic volunteers, to evaluate the effectiveness of DehydraTECH-processed semaglutide [144]. - Lexaria has selected a CRO for a new human pilot study on DehydraTECH-tirzepatide capsules, expected to be completed by the end of June 2024 [123]. - The company is conducting a comprehensive R&D program to evaluate DehydraTECH for improved delivery of GLP-1 and GIP drugs, targeting commercial partnerships with global pharmaceutical companies [141]. Financial Performance - Total revenue for the nine months ended May 31, 2024, was $380,278, compared to $195,467 for the same period in 2023, representing a 94% increase [128]. - Revenue for the three months ended May 31, 2024, was $84 million, a 8.3% increase from $77.7 million for the same period in 2023 [160]. - Gross profit for the nine months ended May 31, 2024, was $375.5 million, compared to $164 million for the same period in 2023, representing a 128.5% increase [160]. - Total operating expenses for the three months ended May 31, 2024, were $1.83 million, a decrease of 26% from $2.47 million for the same period in 2023 [160]. - Net loss attributable to Lexaria shareholders for the nine months ended May 31, 2024, was $3.61 million, compared to $5.43 million for the same period in 2023, reflecting a 33.5% improvement [160]. - Basic and diluted loss per share for the three months ended May 31, 2024, was $(0.13), compared to $(0.37) for the same period in 2023 [160]. - The Company reported net losses of $3,622,083 and $5,463,510 for the nine-month periods ended May 31, 2024, and 2023, respectively [214]. Capital and Funding - Lexaria raised $3.0 million from a registered direct offering on February 16, 2024, issuing 1,444,741 shares of common stock and 113,702 pre-funded warrants [113]. - The company has entered into a Securities Purchase Agreement, resulting in net proceeds of $1.25 million from a registered direct offering and concurrent private placement [152]. - The Company raised gross proceeds of $4,407,444 from a Warrant Exercise Agreement on April 30, 2024 [220]. - The Company issued 889,272 shares of common stock and 729,058 pre-funded warrants on October 3, 2023, with net proceeds totaling $1.25 million [220]. - The company reported an accumulated deficit of $(49.37) million as of May 31, 2024, compared to $(45.76) million as of August 31, 2023 [182]. Assets and Liabilities - Total assets as of May 31, 2024, amounted to $10,018,437, up from $5,239,637 as of May 31, 2023, indicating a 91% increase [128]. - Total liabilities as of May 31, 2024, were $271.4 million, down from $403.9 million as of August 31, 2023 [182]. - Current assets increased to $9,093,379 as of May 31, 2024, compared to $2,151,213 as of August 31, 2023 [218]. - Net working capital improved to $8,937,331 as of May 31, 2024, up from $1,883,478 as of August 31, 2023 [218]. - The total present value of operating lease liabilities is reported at $115,327, with total lease payments amounting to $167,424 [127]. Intellectual Property - Lexaria's patent portfolio includes applications for DehydraTECH formulations for cannabinoids, fat-soluble vitamins, and other bioactive compounds, with ongoing investigations for patent protection expansion [115][116]. - The company is actively seeking beneficial acquisitions of intellectual property to enhance its portfolio and market position [135]. - Intellectual property assets increased to $498,878 as of May 31, 2024, compared to $462,625 as of August 31, 2023, reflecting a growth of 8% [159]. Other Developments - DehydraTECH technology is being evaluated for applications beyond pharmaceuticals, including foods, beverages, cosmetics, and nutraceuticals [131]. - The FDA provided a positive response regarding DehydraTECHCBD for hypertension treatment, and the Company submitted its IND application on January 29, 2024 [210]. - The Company plans to conduct long-term stability testing for DehydraTECH compositions over 6-12 months [209]. - The company has no off-balance sheet arrangements that could materially affect its financial condition [212].

S-1 1 lxrp_s1.htm FORM S-1 As filed with the U.S. Securities and Exchange Commission on June 3, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 UNDER THE SECURITIES ACT OF 1933 LEXARIA BIOSCIENCE CORP. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) Nevada 2000 20-2000871 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 100-740 McCurdy ...

Technology and Product Development - Lexaria's DehydraTECH technology improves the delivery of Active Pharmaceutical Ingredients (APIs), resulting in sustained higher levels of semaglutide in blood and reduced side effects in a pilot study[101]. - The company completed a pilot study showing that DehydraTECH-semaglutide capsules achieved faster peak drug delivery and sustained lower blood glucose levels compared to Rybelsus tablets[114]. - Lexaria plans to evaluate DehydraTECH for improved delivery of GLP-1 and GIP drugs, targeting commercial partnerships with global pharmaceutical companies[115]. - Lexaria's DehydraTECH technology is applicable across various sectors, including pharmaceuticals, foods, beverages, and cosmetics[100]. - The company is advancing several R&D activities, including formulations for CBD in hypertension and nicotine for reduced-risk oral pouches[112]. Financial Performance - The company reported a net loss of $1,837,771 for the six months ended February 29, 2024, compared to a net loss of $3,079,944 for the same period in 2023, reflecting a decrease in losses of $1,242,173[131]. - Revenues increased to $296,278 for the six months ended February 29, 2024, up from $117,760 in the same period in 2023, marking a year-over-year increase of $178,518[131]. - Research and development expenditures decreased by $705,397 year-over-year, primarily due to the completion of various R&D studies and manufacturing of DehydraTECH-CBD[133]. - The company anticipates increased expenditures related to ongoing R&D programs, particularly for animal and human clinical trials of DehydraTECH formulations, leading to expected operating losses and negative cash flows in the foreseeable future[125]. - The company has an accumulated deficit of $47.6 million as of February 29, 2024, and expects to continue incurring significant operational expenses and net losses in the upcoming 12 months[144]. Capital Raising and Share Issuance - Lexaria raised $3.0 million from a registered direct offering, issuing 1,444,741 shares of common stock and 113,702 pre-funded warrants[104]. - The company issued 1,119,250 common shares from warrant exercises, generating gross proceeds of $1,063,475 at an exercise price of $0.95 per share[105]. - The Company issued 1,444,741 shares of common stock and 113,702 pre-funded warrants in a registered direct offering on February 16, 2024, with net proceeds of $3.0 million[148]. - On October 3, 2023, the Company issued 889,272 shares of common stock and 729,058 pre-funded warrants, generating net proceeds of $1.25 million[148]. Assets and Liabilities - As of February 29, 2024, the company had current assets of $5,416,984 and current liabilities of $81,717, resulting in net working capital of $5,335,267[139]. - As of February 29, 2024, the Company had cash and cash equivalents of approximately $4.7 million to settle $81,717 in current liabilities[147]. - Net cash used in operating activities was approximately $1.8 million for the six months ended February 29, 2024, a decrease from $2.5 million in the same period in 2023[141]. Legal and Compliance - Legal and professional fees increased by $163,755 during the period due to increased patent filings and additional legal advisory services[137]. - The Principal Executive Officer and Principal Financial Officer concluded that the Company's disclosure controls and procedures were effective at a reasonable assurance level as of February 29, 2024[150]. - There have been no changes in the Company's internal controls over financial reporting during the quarter ended February 29, 2024, that materially affect the controls[152]. - The Company is not party to any material, pending, or existing legal proceedings against it or its subsidiaries[153]. Research and Development Initiatives - The company received a Study May Proceed letter from the FDA for its Phase 1b hypertension clinical trial of DehydraTECH-CBD, enabling further clinical studies[102]. - The company plans to conduct multiple human pilot studies in 2024, targeting the evaluation of DehydraTECH formulations of GLP-1 drugs[117][118][119]. - The company is exploring beneficial acquisitions of intellectual property to enhance its portfolio and support ongoing research initiatives[108].

S-1 1 lxrp_s1.htm FORM S-1 As filed with the Securities and Exchange Commission on March 12, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 UNDER THE SECURITIES ACT OF 1933 LEXARIA BIOSCIENCE CORP. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) Nevada 2000 20-2000871 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 100-740 McCurdy Ro ...