NASDAQ Relisting and Corporate Stability
Successfully completed appeal and had shares relisted on NASDAQ, removing a significant listing overhang and allowing management to refocus on execution and commercialization.
CoSara India: Manufacturing License and Regional Expansion
CoSara received CDSCO license to manufacture the PCR Pro instrument in India, preparing local production of instrument and consumables; commercial/distribution territory expanded to Bangladesh, Pakistan, Nepal and Sri Lanka, increasing addressable market from about $11B to ~$13B.
TB Opportunity and WHO Alignment
Preparing TB clinical performance studies in India where TB burden is highest; WHO updated guidance favoring near point-of-care molecular TB tests and tongue swab sampling — tests designed for SARS platform are aligned with this guidance; preclinical third-party studies showed performance comparable to or exceeding other molecular TB tests; management expects TB commercialization in India by Q3 2026.
CoMira Joint Venture Progress in MENA
CoMira JV with Arabian Eagle progressing toward local manufacturing in Saudi Arabia with lease finalization and operational readiness across Saudi and 18 additional MENA markets; expected to be first domestic manufacturer of molecular diagnostics in the Kingdom, strengthening regional positioning.
Clinical Pipeline and Trial Enrollment
Upper respiratory multiplex clinical program progressing with enrollment in ~8 U.S. locations; management reported in excess of 1,200 patients already enrolled and will move forward with an initial FDA submission focusing on flu A, flu B and RSV to accelerate timelines while keeping option to add COVID later.
Intellectual Property Strengthening
Received international patent grants covering core components of the Co-Dx PCR platform, including grants in Australia and Japan, bolstering IP protection ahead of commercialization and international expansion.
AI Platform Expansion
Expanding Co-Dx primer AI platform to support assay design, result interpretation and predictive insights; multiple AI models already in place, representing a longer-term revenue/efficiency opportunity.
Cost Discipline and Adjusted EBITDA Improvement (Excluding Impairment)
Excluding a noncash impairment, operating expenses declined year-over-year (R&D down 9.1% to $19.1M, sales & marketing down 46.7% to $2.4M, G&A down 43.8% to $9.1M) and Adjusted EBITDA improved to a loss of $28.0M from a loss of $33.5M (improvement of ~$5.5M, ~16.4%).