Tonix Pharmaceuticals Updates on TNX-4800 Program
Tonix Pharmaceuticals announced program updates on TNX-4800, which is a long-acting human monoclonal antibody that targets the outer surface protein A of Borrelia burgdorferi, the causative agent of Lyme disease in humans. TNX-4800 is being developed for annual seasonal use, as one subcutaneous administration in the spring to protect against Lyme disease through fall, or the entire tick season in the U.S. There are no currently marketed U.S. Food and Drug Administration-approved vaccines or prophylactics to protect against Lyme disease. "We plan to meet with the FDA in 2026 to explore Phase 2/3 development options," said Seth Lederman, CEO. "We believe a controlled human infection model study using Borrelia-infected ticks that mimics natural infection would be a potential path to demonstrating TNX-4800 efficacy for approval. We are on a path to have investigational product produced under Good Manufacturing Practices available for testing early in 2027. We believe TNX-4800's long-acting mAb prophylaxis could play an important role for preventing Lyme for millions of people who live, work, and vacation in regions endemic for Lyme disease. TNX-4800 provides near-immediate immunity to the bacteria that cause Lyme disease after a single administration, which is very different from Lyme disease vaccine programs currently in development. Prophylaxis with TNX-4800 may also avoid the limitations of vaccine products designed to actively immunize against Lyme, including suboptimal immune responses from age, immunocompetence, and other reasons."
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Tonix Pharmaceuticals to Present at January 2026 Investor Conferences
- Investor Conference Schedule: Tonix Pharmaceuticals will present at the Neuroscience Innovation Forum and Biotech Showcase on January 11 and 13, 2026, showcasing innovations in neuropsychiatric drug development, which is expected to attract potential investor interest.
- Leadership Participation: CEO Seth Lederman, M.D. will lead multiple sessions, emphasizing the company's leadership in biotechnology, aiming to enhance Tonix's market visibility and investor confidence.
- Product Line Showcase: Tonix will highlight its FDA-approved non-opioid analgesic TONMYA and other acute migraine treatments, demonstrating its market potential in chronic pain and CNS disorders.
- R&D Investment Outlook: Tonix's development pipeline includes candidates for rare diseases and infectious diseases, which is expected to generate interest in biotech investments and further enhance the company's competitiveness in the industry.
Tonix Pharmaceuticals (TNXP) Enters $20M Securities Purchase Agreement with Point72
- Securities Purchase Agreement: Tonix Pharmaceuticals has entered into a securities purchase agreement with Point72 for the sale of 615,025 shares at $16.26 each, expected to close around December 30, subject to customary conditions, which will generate approximately $20 million in gross proceeds to enhance the company's liquidity for future R&D support.
- Pre-Funded Warrant Structure: In addition to common stock, the agreement includes pre-funded warrants allowing the purchase of 615,025 shares at $16.259 each, optimizing the financing structure and reducing overall financing costs for the company.
- Underwriter Role: TD Cowen is acting as the sole placement agent for this transaction, while A.G.P./Alliance Global Partners serves as financial advisor, ensuring smooth execution and boosting market confidence, reflecting investor trust in Tonix's future prospects.
- Funding Utilization Outlook: This financing will provide Tonix with essential capital to support ongoing investments in clinical trials and product development, particularly for the upcoming Phase 2/3 trial of TNX-4800, potentially driving long-term growth for the company.
