Nabriva Therapeutics has filed an amended F-1 form with the U.S. Securities and Exchange Commission (SEC) for its initial public offering (IPO). No terms were given in the filing. The company intends to list its American depository shares (ADSs) on the Nasdaq Global Market under the symbol NBRV.
The underwriters for the offering are Leerink Partners, RBC Capital Markets, Needham and Wedbush PacGrow.
This is a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics. The company is developing its lead product candidate, lefamulin, to be the first pleuromutilin antibiotic available for systemic administration in humans.
Separately, it is developing both intravenous and oral formulations of lefamulin for the treatment of community-acquired bacterial pneumonia (CABP) and intends to develop lefamulin for additional indications other than pneumonia. The company completed a Phase 2 clinical trial of lefamulin for acute bacterial skin and skin structure infections (ABSSSI).
The company further detailed in the filing:
Based on the clinical results of lefamulin for ABSSSI, as well as its rapid tissue distribution, including substantial penetration into lung tissue and fluids, we are preparing to initiate two international, pivotal Phase 3 clinical trials of lefamulin for the treatment of moderate to severe CABP. These will be the first clinical trials we have conducted with lefamulin for the treatment of CABP. We plan to initiate the first of these trials in the fall of 2015 and the second trial in the first half of 2016. Based on our expectations regarding initiation of these trials and our estimates regarding patient enrollment, we expect to have top-line data available for both trials in late 2017. If the results of these trials are favorable, including achievement of the primary efficacy endpoints of the trials, we expect to submit applications for marketing approval for lefamulin for the treatment of CABP in both the United States and Europe in 2018.
Nabriva intends to use the proceeds from this offering to fund its studies, as well as for working capital and general corporate purposes.
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