FDA Approval for ORLYNVAH
Received FDA approval for ORLYNVAH, an oral sulopenem product for treating uncomplicated urinary tract infections, marking the first U.S. approval of an oral product in the penem class.
Market Exclusivity and Patent Protection
ORLYNVAH has 10 years of market exclusivity under the GAIN Act and patent protection until 2039 in the U.S., which includes method of use and composition of matter.
Significant Decrease in Operating Expenses
Total operating expenses decreased from $16.7 million in Q3 2023 to $4.9 million in Q3 2024, primarily due to lower R&D costs following the completion of the REASSURE trial.
Cash Runway Extended
The company expects to fund operations into 2025, including the repayment of exchangeable notes due January 31, 2025.