Nabriva Therapeutics A.G. has filed an amended F-1 form with the U.S. Securities and Exchange Commission (SEC) for its initial public offering (IPO) in the United States. The filing set terms for the IPO with each American depositary share (ADS) having an expected price range of $15 to $17 for 6 million ADSs; each ADS represents one-tenth of a common share.  The company intends to list on the Nasdaq Global Market under the symbol NBRV.

The underwriters for the offering are Leerink Partners, RBC Capital, Needham and Wedbush.

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. Nabriva is developing both intravenous (IV) 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.

Nabriva has completed a phase 2 clinical trial of lefamulin for acute bacterial skin and skin structure infections (ABSSSI). Based on the clinical results of lefamulin for ABSSSI, as well as its rapid tissue distribution, including substantial penetration into lung tissue and fluids, the company is 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 the company has conducted with lefamulin for the treatment of CABP.

The company plans to initiate the first of these trials in the fall of 2015 and the second trial in the first half of 2016. Based on the expectations regarding initiation of these trials and estimates regarding patient enrollment, top-line data available for both trials is expected in late 2017. If the results of these trials are favorable, including achievement of the primary efficacy endpoints of the trials, Nabriva expects to submit applications for marketing approval for lefamulin for the treatment of CABP in both the U.S. and Europe in 2018.

The company expects to use the net proceeds from this offering to fund the clinical development of lefamulin, repay its indebtedness, and for general corporate purposes.

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