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Nabriva Therapeutics Provides Business and Development Update and Reports 2016 Financial ResultsVIENNA, Austria and KING OF PRUSSIA, Pa., March 24, 2017 (GLOBE NEWSWIRE) -- Nabriva Therapeutics AG (NASDAQ:NBRV), 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, today provided a business and clinical development update and reported its financial results for the year ended December 31, 2016. “For the last 12 months, we have been executing our clinical development program and are continuing to make progress enrolling our ongoing pivotal Phase 3 clinical trials—known as LEAP 1 and LEAP 2—evaluating lefamulin for the treatment of patients with moderate to severe community-acquired bacterial pneumonia (CABP),” said Dr. Colin Broom, Chief Executive Officer of Nabriva. “This is poised to be a potentially transformational year for Nabriva, as we expect top-line clinical data from LEAP 1 in the third quarter of 2017. In addition, based on current projections, we expect to complete patient enrollment for LEAP 2 in the fourth quarter of 2017 and we anticipate receiving top-line data for LEAP 2 in the first quarter of 2018.” “CABP is a serious respiratory infection in need of new treatment options, as increasing bacterial resistance is rendering existing antibiotics less effective. We believe that lefamulin offers the potential benefit of a monotherapy with targeted activity against the most common pathogens causing CABP, including multidrug resistant strains,” said Dr. Elyse Seltzer, Nabriva’s Chief Medical Officer. “Additionally, with the requirement in 2017 for US hospitals to implement an antibiotic stewardship program to drive the appropriate use of antibiotics, we believe that it is critically important to develop antibiotics that align with these stewardship principles and offer a new, pragmatic option for treating CABP. With its novel mechanism of action, targeted spectrum of activity, lack of cross resistance with other commonly used respiratory antibiotics, IV and oral formulations and favorable tolerability profile, we believe that if approved, lefamulin may be well-positioned as an empiric monotherapy for the treatment of moderate to severe CABP.” FULL YEAR 2016 AND RECENT CORPORATE AND DEVELOPMENT HIGHLIGHTS
FULL YEAR 2016 FINANCIAL HIGHLIGHTS
About Nabriva Therapeutics AG Nabriva Therapeutics owns exclusive, worldwide rights to lefamulin, which is protected by composition of matter patents issued in the United States, Europe and Japan. Forward Looking Statements FINANCIAL REVIEW We are 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. We are developing our lead product candidate, lefamulin, to be the first pleuromutilin antibiotic available for systemic administration in humans. We are developing both intravenous, or IV, and oral formulations of lefamulin for the treatment of community-acquired bacterial pneumonia, or CABP, and intend to develop lefamulin for additional indications other than pneumonia. We have completed a Phase 2 clinical trial of lefamulin for acute bacterial skin and skin structure infections, or ABSSSI. Based on the clinical results of lefamulin for ABSSSI, as well as its rapid tissue distribution, including substantial penetration into lung fluids and lung immune cells, we have initiated two pivotal, international Phase 3 clinical trials of lefamulin for the treatment of moderate to severe CABP. We initiated the first of these trials, which we refer to as LEAP 1, in September 2015 and initiated the second trial, which we refer to as LEAP 2, in April 2016. These are the first clinical trials we have conducted with lefamulin for the treatment of CABP. Both trials are designed to follow draft guidance published by the FDA for the development of drugs for CABP and guidance from the European Medicines Agency, or EMA, for the development of antibacterial agents. Based on our estimates regarding patient enrollment, we expect to have top-line data from LEAP 1 in the third quarter of 2017. With respect to LEAP 2, based on current projections, we expect to complete patient enrollment in the fourth quarter of 2017, and we anticipate receiving top-line data for LEAP 2 in the first quarter of 2018. 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. We believe that lefamulin is well suited for use as a first-line empiric monotherapy for the treatment of CABP because of its novel mechanism of action, spectrum of activity, including against multi-drug resistant pathogens, achievement of substantial drug concentrations in lung fluids and lung immune cells, availability as both an IV and oral formulation and favorable safety and tolerability profile. The U.S. Food and Drug Administration, or FDA, has designated each of the IV and oral formulations of lefamulin as a qualified infectious disease product, or QIDP, which provides for the extension of statutory exclusivity periods in the United States for an additional five years upon FDA approval of the product for the treatment of CABP and granted fast track designation to these formulations of lefamulin. Fast track designation is granted by the FDA to facilitate the development and expedite the review of drugs that treat serious conditions and address significant medical needs. The fast track designation for the IV and oral formulations of lefamulin will allow for more frequent interactions with the FDA, the opportunity for a rolling review of any new drug application, or NDA, we submit and eligibility for priority review and a shortening of the FDA’s goal for taking action on a marketing application from ten months to six months. We believe that pleuromutilin antibiotics can help address the major public health threat posed by bacterial resistance, which the World Health Organization, or WHO, characterized in 2010 as one of the three greatest threats to human health. Increasing resistance to antibiotics used to treat CABP is a growing concern and has become an issue in selecting the appropriate initial antibiotic treatment prior to determining the specific microbiological cause of the infection, referred to as empiric treatment. For example, the U.S. Centers for Disease Control and Prevention, or CDC, has classified Streptococcus pneumoniae, the most common respiratory pathogen, as a serious threat to human health as a result of increasing resistance to currently available antibiotics. In addition, the CDC recently reported on the growing evidence of widespread resistance to macrolides, widely used antibiotics that disrupt bacterial protein synthesis, in Mycoplasma pneumoniae, a common cause of CABP that is associated with significant morbidity and mortality. Furthermore, Staphylococcus aureus, including methicillin-resistant S. aureus, or MRSA, which has also been designated as a serious threat to human health by the CDC, has emerged as a more common cause of CABP in some regions of the world, and a possible pathogen to be covered with empiric therapy. In recognition of the growing need for the development of new antibiotics, recent regulatory changes, including priority review and regulatory guidance enabling smaller clinical trials, have led to renewed interest from the pharmaceutical industry in anti-infective development. For example, the Food and Drug Administration Safety and Innovation Act became law in 2012 and included the Generating Antibiotic Incentives Now Act, or the GAIN Act, which provides incentives, including access to expedited FDA review for approval, fast track designation and five years of potential data exclusivity extension for the development of new QIDPs. Please refer to our Form 10-K filed with the U.S. Securities and Exchange commission for additional information regarding our business and financial results and to review our audited financial statements. Below are certain explanations of 2016 activity versus 2015. Research Premium and Grant Income Other income increased by $2.7 million from $3.8 million for the year ended December 31, 2015 to $6.5 million for the year ended December 31, 2016. The change was primarily due to a $2.6 million increase in anticipated grant income from research premiums provided to us by the Austrian government as a result of increases in our applicable research and development expenses. Research and Development Expenses Research and development expenses increased by $24.4 million from $23.6 million for the year ended December 31, 2015 to $48.0 million for the year ended December 31, 2016. The increase was primarily due to higher costs related to our Phase 3 clinical trials of lefamulin. Direct costs for our other programs and initiatives were relatively limited during both periods. Indirect costs related to research and development increased for the year ended December 31, 2016 compared to the same period in 2015, primarily due to the addition of employees in our clinical development department. General and Administrative Expenses General and administrative expense increased by $5.6 million from $7.9 million for the year ended December 31, 2015 to $13.5 million for the year ended December 31, 2016. The increase was primarily due to increased staff costs related to the hiring of additional employees and increased professional service fees related to operating as a public company. Other income (expense), net Other income (expense), net decreased by $3.2 million to a $0.8 million loss during the year ended December 31, 2016 compared to the same period in 2015. The change was primarily due to an increase in unrealized losses from the re-measurement of foreign currency balances. Interest expense, net During the year ended December 31, 2016, net interest expenses decreased by $22.3 million compared to the same period in 2015 primarily due to the decrease in the effective interest accrued under the convertible loan agreements, which were converted into equity securities in connection with our April 2015 financing, and the decrease in interest expense on the Kreos loan, which was fully repaid in November 2015. Cash Flows Operating Activities Cash flow utilized by operating activities increased by $27.4 million from $21.9 million for the year ended December 31, 2015 to $49.3 million for the year ended December 31, 2016 primarily due to a $28.4 million increase in net loss, after adjustments for non-cash amounts included in net income partially offset by improved working capital of $1.0 million primarily from an increase of accrued expense and other current liabilities. Investing Activities Cash flow from investing activities changed by $100.1 million from $76.7 million cash outflow in the year ended December 31, 2015 to $23.4 million cash inflow in the year ended December 31, 2016 primarily due to the redemption of term deposits. Other investing activities were relatively insignificant in both periods and related primarily to the acquisition of equipment in support of our research and development activities. Financing Activities Cash flow generated from financing activities decreased by $110.7 million from $133.0 million in the year ended December 31, 2015 to $22.3 million during the year ended December 31, 2016 primarily due to proceeds of $44.8 million from our April 2015 financing and proceeds of $106.1 million from our initial public offering in September 2015, $3.4 million from the issuance of an additional convertible loan in January 2015 and proceeds of $0.9 million from a silent partnership agreement entered into in January 2015. The year over year decrease in financing cash inflows was partially offset by proceeds of $24.8 million from our December 2016 rights offering, a $7.4 million decrease of cash outflows for repayments of long-term borrowings, and a $12.1 million decrease in equity transaction costs.
Contact: INVESTOR RELATIONS Will Sargent Nabriva Therapeutics AG [email protected] 610-813-6406 MEDIA Katie Engleman Pure Communications, Inc. [email protected] 910-509-3977 |