Core Viewpoint - Lexaria Bioscience Corp. will participate in the 27th Annual H.C. Wainwright Global Investment Conference from September 8th to September 10th, 2025, highlighting its innovative drug delivery technology, DehydraTECH [1][3]. Company Overview - Lexaria Bioscience Corp. is a global innovator in drug delivery platforms, focusing on improving the way drugs enter the bloodstream through oral delivery [1][3]. - The company operates a licensed in-house research laboratory and holds a strong intellectual property portfolio with 50 patents granted and additional patents pending worldwide [3]. Technology Highlights - DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform that enhances bio-absorption, reduces side effects, and improves drug delivery across the blood-brain barrier [3].

Core Insights - Lexaria Bioscience Corp. has received 2 new international patents, increasing its total patent portfolio to 50 [1][2] - The new patents include one for treating epilepsy and another for sublingual delivery of nicotine, enhancing Lexaria's intellectual property protection [2][3] - The epilepsy drug market was valued at US$9.5 billion in 2023 and is projected to exceed US$15 billion by 2032, indicating significant growth potential [4] - The global retail oral nicotine market was valued at US$5.5 billion in 2023 and is expected to grow at a rate of 26% per year until at least 2030 [5] Company Developments - Lexaria's new patent for epilepsy treatment broadens its intellectual property protection outside the USA, where it already holds 6 existing patents [2] - The new patent for sublingual delivery of nicotine adds to existing patents in the USA and Canada, further solidifying Lexaria's position in the nicotine market [3] - The new patents are seen as a strategic move to enhance commercial opportunities within the pharmaceutical industry and to build long-term value for shareholders [2] Market Context - Approximately 50 million people in the US are affected by epilepsy, highlighting a substantial patient population for potential treatments [4] - The nicotine pouch market, where Lexaria's DehydraTECH™ technology has shown absorption benefits, is expected to reach US$25.4 billion in revenue by 2030 [5] - Lexaria's DehydraTECH™ technology improves the delivery of active pharmaceutical ingredients, demonstrating increased bio-absorption and effectiveness across the blood-brain barrier [6]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company's cash, cash equivalents, and marketable securities totaled approximately $144.8 million [22] - Revenues for Q1 2025 were zero, compared to approximately $4.9 million for Q1 2024, with the previous revenue being recognized from a $40 million distribution agreement [22][23] - Operating expenses for Q1 2025 were approximately $16.2 million for R&D, up from approximately $10.1 million in Q1 2024, and general and administrative expenses were approximately $3.1 million, compared to $1.8 million in Q1 2024 [24][25] - The net loss for Q1 2025 was approximately $24.4 million, compared to a net loss of approximately $9.8 million for Q1 2024 [25] Business Line Data and Key Metrics Changes - The company is focused on the BLA for daramycin, a therapy for Duchenne muscular dystrophy (DMD) cardiomyopathy, with ongoing preparations for an FDA advisory committee meeting [4][5] - The company has been providing daramycin to open label extension patients for over three years, with plans for over 100 patients to transition to commercial products following potential BLA approval [12][13] Market Data and Key Metrics Changes - The company is negotiating with Nippon Shinyaku for the distribution of daramycin in Europe, with an extended negotiation period through the end of Q2 [17] - The company is also exploring opportunities for its technology in other global markets [17] Company Strategy and Development Direction - The company aims to transition from a translational medicine company to a commercial stage entity, actively working with NS Pharma on launch readiness in the U.S. [11] - The strategy includes enhancing medical leadership and preparing physicians for prescribing daramycin, which targets inflammation and fibrosis associated with DMD [14][39] - The company is also developing its Stealth Exosome Platform technology for next-generation drug delivery [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the FDA's review process and the strength of the data supporting daramycin's efficacy and safety [4][30] - The company has a cash balance of approximately $145 million, with a runway extending into 2027 without additional cash infusions [19] - If FDA approval is received, the company expects to receive an $80 million milestone payment and a priority review voucher, potentially totaling over $200 million in non-dilutive cash [20] Other Important Information - The company has appointed Dr. Michael Binks as the new Chief Medical Officer, bringing over 25 years of experience in clinical development [12] - The San Diego GMP manufacturing facility is fully operational and producing doses of daramycin, with plans for expansion to meet potential demand [15][16] Q&A Session Summary Question: Has the site inspection in San Diego occurred? - The site inspection is scheduled for this quarter, and preparations are underway [28] Question: What is the status of negotiations with Nippon Shinyaku? - The company is actively negotiating with Nippon Shinyaku and evaluating opportunities for launching in Europe independently [34][37] Question: What are the key drivers of proof for the efficacy of daramycin? - The statistical significance of cardiac MRI data is a key driver, indicating that the treatment effects are unlikely due to chance [44][59] Question: What is the plan if the FDA issues a CRL for efficacy? - The company would submit data from the HOPE-three trial for skeletal muscle dysfunction if a CRL is issued [53][54] Question: What is the company's plan for the priority review voucher? - The current plan is to sell the priority review voucher to strengthen the balance sheet [69]

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].