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“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.
“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.
FULL YEAR 2016 AND RECENT CORPORATE AND DEVELOPMENT HIGHLIGHTS
February 2017, Nabriva confirmed no sample size adjustment was recommended for the lefamulin evaluation against pneumonia (LEAP 1) trial. LEAP 1 is a Phase 3 global, registrational clinical trial evaluating the safety and efficacy of lefamulin (IV/po) in patients with moderate to severe CABP. Following completion of LEAP 1 enrollment in the second quarter of 2017 and final data collection and analysis, the company expects to announce LEAP 1 top-line efficacy and safety data in the third quarter of 2017.
October 2016, at IDWeek 2016, Nabriva presented data that supports IV and oral dosing selection in lefamulin’s ongoing Phase 3 clinical development program.
June 2016, at the American Society of Microbiology (ASM) Microbe Conference, Nabriva presented in vitro data demonstrating activity of lefamulin against Mycoplasma pneumoniae, including macrolide-resistant strains.
April 2016, Nabriva initiated its second global, registrational Phase 3 clinical trial of oral lefamulin (LEAP 2) in patients with moderate CABP. LEAP 2 is designed to enroll approximately 740 patients at approximately 160 centers.
April 2016, oral lefamulin was granted Qualified Infectious Disease Product (QIDP) status by the FDA.
December 2016, Nabriva completed a rights offering and a subsequent underwritten offering, pursuant to Austrian Corporate law, which together generated aggregate gross proceeds of approximately $25 million. Aggregate net proceeds to Nabriva from the rights offering and the underwritten offering were approximately $21 million, after deducting estimated fees and offering expenses. The company plans to use the net proceeds from the rights offering and the underwritten offering for general corporate purposes, including working capital and pre-commercial activities.
March 24, 2017, Nabriva’s supervisory board authorized management to pursue a plan for the redomiciliation of its ultimate parent company from Austriato Ireland. The company is working with its advisors to structure and implement such a redomiciliation plan. The company currently anticipates that the plan, which will require further approval of the supervisory board, will be presented to Nabriva’s shareholders for their consideration during 2017. Nabriva may abandon its redomiciliation plan at any time and there can be no assurance that it will redomicile from Austriato Irelandduring 2017, or at all.
FULL YEAR 2016 FINANCIAL HIGHLIGHTS
- For the year ended
December 31, 2016, Nabriva reported a net loss of $54.9 millionor $25.56per share, compared to a net loss of $47.0 millionor $44.37per share for the year ended December 31, 2015.
- Research and development expenses increased from
$23.6 millionfor the year ended December 31, 2015to $48.0 millionfor the year ended December 31, 2016. The increase was primarily due to higher costs related to the company’s ongoing Phase 3 clinical trials of lefamulin.
- General and administrative expense increased from
$7.9 millionfor the year ended December 31, 2015to $13.5 millionfor 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.
- As of
December 31, 2016, Nabriva had $83.9 millionin cash, cash equivalents and short-term investments compared to $111.4 millionas of December 31, 2015. We expect that this year-end balance will be sufficient to fund our operating expenses and capital expenditures at least into the second quarter of 2018.
About Nabriva Therapeutics AG
Nabriva Therapeutics is a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infectives to treat serious infections, with a focus on the pleuromutilin class of antibiotics. Nabriva Therapeutics’ medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations of its lead product candidate, lefamulin. Lefamulin is a novel semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class available for systemic administration in humans. The company believes that lefamulin is the first antibiotic with a novel mechanism of action to have reached late-stage clinical development in more than a decade. Lefamulin is currently being evaluated in two global, registrational Phase 3 clinical trials in patients with moderate to severe CABP. Nabriva believes lefamulin is well positioned for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, oral and IV formulations and a favorable tolerability profile.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for Nabriva, including but not limited to statements about the development of Nabriva’s product candidates, such as plans for the design, conduct and timelines of Phase 3 clinical trials of lefamulin for CABP, the clinical utility of lefamulin for CABP and Nabriva’s plans for filing of regulatory approvals and efforts to bring lefamulin to market, the development of lefamulin for additional indications, the development of additional formulations of lefamulin, plans to pursue research and development of other product candidates, the sufficiency of Nabriva’s existing cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including lefamulin for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption "Risk Factors" in Nabriva’s annual report on Form 10-K filed with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva’s views as of the date of this release. Nabriva anticipates that subsequent events and developments will cause its views to change. However, while Nabriva may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva’s views as of any date subsequent to the date of this release.
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
We believe that pleuromutilin antibiotics can help address the major public health threat posed by bacterial resistance, which the
Please refer to our Form 10-K filed with the
Research Premium and Grant Income
Other income increased by
Research and Development Expenses
Research and development expenses increased by
General and Administrative Expenses
General and administrative expense increased by
Other income (expense), net
Other income (expense), net decreased by
Interest expense, net
During the year ended
Cash flow utilized by operating activities increased by
Cash flow from investing activities changed by
Cash flow generated from financing activities decreased by
|Comparison of Years Ended December 31, 2015 and 2016|
|Year ended December 31,|
|Consolidated Operations Data:|
|Costs and Expenses:|
|Research and development||(23,604||)||(47,994||)||(24,390||)|
|General and administrative||(7,921||)||(13,535||)||(5,614||)|
|Total operating expenses||(31,525||)||(61,529||)||(30,004||)|
|Loss from operations||(27,758||)||(55,047||)||(27,289||)|
|Other income (expense):|
|Other income (expense), net||2,427||(783||)||(3,210||)|
|Interest income (expense), net||(22,078||)||268||(22,346||)|
|Loss before income taxes||(47,409||)||(55,562||)||(8,153||)|
|Income tax (expense) benefit||445||672||227|
|Net income (loss)||$||(46,964||)||$||(54,890||)||$||(7,926||)|
|Consolidated Balance Sheets|
|As of December 31|
|(in thousands, except per share data)||2015||2016|
|Cash and cash equivalents||$||36,446||$||32,778|
|Total current assets||116,245||90,621|
|Property, plant and equipment, net||417||519|
|Intangible assets, net||3||270|
|Deferred tax assets||616||1,410|
|Liabilities and equity|
|Accrued expense and other current liabilities||5,823||13,308|
|Income taxes payable||170||18|
|Total current liabilities||8,921||15,877|
|Other non-current liabilities||84||107|
|Commitments and contingencies (Note 21)|
|Investment from silent partnership||$||-||$||-|
|Total mezzanine equity||$||-||$||-|
|Common stock - no par value; 912,920 and 1,389,786 shares authorized at December 31, 2015 and 2016;|
|2,116,778 and 2,719,695 issued and outstanding at December 31, 2015 and 2016, respectively||$||2,407||$||2,939|
|Treasury shares -- at cost; 2,819 shares at December 31, 2015 and 0 shares at December 31, 2016, respectively||(25||)||-|
|Additional paid in capital||273,921||279,149|
|Accumulated other comprehensive income (loss)||3,829||10|
|Total stockholder's equity||$||108,706||$||77,256|
|Total liabilities and stockholders' equity||$||117,711||$||93,240|
|Comparison of Years Ended December 31, 2015 and 2016|
|The following table summarizes our cash flows for the years ended December 31, 2015 and 2016:|
|Year ended December 31,|
|Net cash (used in) provided by:|
|Effect of foreign currency translation on cash||(160||)||-|
|Net increase (decrease) in cash||34,296||(3,668||)|
Contact: INVESTOR RELATIONS
Will Sargent Nabriva Therapeutics AGWilliam.Sargent@nabriva.com 610-813-6406 MEDIA Katie Engleman Pure Communications, Inc.Katie@purecommunicationsinc.com 910-509-3977