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Mar 31, 2022
Tonix Q1 2022 Earnings Report
Reported financial results for the first quarter ended March 31, 2022, and provided an overview of recent operational highlights.
Key Takeaways
Tonix Pharmaceuticals reported $140.4 million in cash and cash equivalents as of March 31, 2022. The company's R&D expenses were $18.4 million, and G&A expenses were $8.0 million for the first quarter of 2022. Net loss per common share was $0.05.
Initiated Fibromyalgia Phase 3 Trial of TNX-102 SL, with interim analysis results expected in the first quarter of 2023.
Long COVID IND was cleared for TNX-102 SL, and Phase 2 trial is expected to start in the second quarter of 2022.
Three additional CNS programs are expected to initiate Phase 2 studies in 2022: TNX-1300 for Cocaine Intoxication, TNX-1900 for Chronic Migraine, and TNX-102 SL for PTSD.
FDA granted Orphan-Drug Designation for TNX-2900 for the treatment of Prader-Willi Syndrome.
Tonix
Tonix
Forward Guidance
Tonix Pharmaceuticals anticipates advancing its clinical development programs and investing in its development pipeline throughout 2022.
Positive Outlook
- Expects to have five central nervous system (CNS) programs in the clinic by the end of the year.
- TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia is in mid-Phase 3 development.
- TNX-102 SL trials in Long COVID and PTSD are expected to initiate enrollment in the second quarter of 2022.
- TNX-1300 (recombinant double mutant cocaine esterase) is expected to start enrolling in a Phase 2 trial in the second quarter of 2022.
- TNX-1900 (intranasal potentiated oxytocin) is expected to enter the clinic in the second half of 2022 for the prevention of migraines in chronic migraineurs.
Challenges Ahead
- Risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations.
- Delays and uncertainties caused by the global COVID-19 pandemic.
- Risks related to the timing and progress of clinical development of product candidates.
- Need for additional financing.
- Uncertainties of patent protection and litigation.