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Lexaria Attending the 27th Annual H.C. Wainwright Global Investment Conference
Thenewswire· 2025-08-27 13:20
Kelowna, British Columbia – August 27, 2025 – TheNewswire - Lexaria Bioscience Corp. (Nasdaq: LEXX, LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, today announced that it will participate in the 27th Annual H.C. Wainwright Global Investment Conference, taking place September 8th through September 10th, 2025. Richard Christopher, Chief Executive Officer of Lexaria Bioscience, will deliver a company presentation and be available for one-on-one investor meetings througho ...
Capricor Therapeutics(CAPR) - 2025 Q1 - Earnings Call Transcript
2025-05-13 21:30
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]
Lexaria Announces Closing of $2 Million Registered Direct Offering of Common Stock
Thenewswire· 2025-04-28 20:15
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].