Tonix Pharmaceuticals reports Q2 EPS ($19,28) with items, consensus ($3.11)

Reports Q2 revenue $2.2M, consensus $3.58M. Q2 EPS results includes a non-cash asset impairment charges totaling $58.9M. As of June 30, Tonix had $4.2M of cash and cash equivalents, compared to $24.9M as of December 31, 2023. “In the Q2, we made significant progress advancing our New Drug Application and market access strategy for TNX-102 SL, or cyclobenzaprine HCl sublingual tablets,” said Seth Lederman, CEO of Tonix. “We are working diligently on the regulatory submission and are pleased to have been granted Fast Track designation by the U.S. FDA and to be in alignment with the agency regarding the content of our proposed NDA package. Fast Track is designed to facilitate the development and expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need. We are hopeful that TNX-102 SL can be the first new drug to treat fibromyalgia in more than 15 years.” Lederman continued, “Additionally, we continue to advance other key pipeline candidates through a capital efficient strategy, including TNX-4200, our broad-spectrum antiviral program for which we were awarded up to $34M over five years from the U.S. Department of Defense to advance its development.”