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Tonix Pharmaceuticals Risk Report

Generated on July 17, 2025

1

Risks

Summary

πŸ›‘οΈ Financial & Liquidity

Tonix Pharmaceuticals has been actively involved in financial activities to strengthen its liquidity. The company has successfully increased its financial reach and made strategic decisions to boost its financial standing. A significant share offering indicates their effort to secure substantial capital for future operations and growth acceleration.

  • Tonix Pharmaceuticals announced a $225 million share offering πŸ—“ June 12, 2025.
  • The company increased its offering to $250 million πŸ—“ December 20, 2024.
  • It reported a strong sales growth and strategic cash position ahead of a critical FDA decision πŸ—“ February 7, 2025.
  • Tonix Pharmaceuticals secures a $98.8 million war chest πŸ—“ March 18, 2025.

βš–οΈ Legal & Regulatory

Tonix Pharmaceuticals is navigating a critical regulatory landscape with potential impactful decisions upcoming. The September FDA approval date for their fibromyalgia treatment is a significant milestone that will impact their market strategy and operations should it be approved.

  • The FDA acceptance and PDUFA goal date of August 15, 2025, for the U.S. marketing approval for TNX-102 SL for fibromyalgia was announced πŸ—“ December 23, 2024.

πŸ“œ Innovation & R&D

Tonix Pharmaceuticals is making strides in research and development, focusing on pioneering treatments and vaccine candidates. Their Phase 3 trial results for fibromyalgia treatment and advances with the MPox vaccine candidate highlight ongoing progress in innovation, potentially positioning them as leaders in these medical areas.

  • Tonix Pharmaceuticals published positive Phase 3 Resilient trial data for TNX-102 SL in fibromyalgia management πŸ—“ July 10, 2025.
  • The company showcased promising TNX-801 vaccine findings πŸ—“ July 10, 2025.
  • It revealed positive topline results from a Phase 1 trial for TNX-1500, focusing on the prevention of kidney transplant rejection and treatment of autoimmune diseases πŸ—“ February 6, 2025.
  • Tonix Pharmaceuticals announced a single-dose vaccine demonstrating 100% protection against the deadly MPox challenge πŸ—“ July 7, 2025.

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Profile

Founded Year
2007
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