Tonix Q1 2022 Earnings Report
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.