NBRV Nabriva Therapeutics plc

0.51
-0.02  -4%
Previous Close 0.53
Open 0.52
52 Week Low 0.485
52 Week High 2.23
Market Cap $73,762,654
Shares 143,955,218
Float 143,158,983
Enterprise Value $35,579,355
Volume 1,330,774
Av. Daily Volume 1,463,815
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Drug Pipeline

Drug Stage Notes
Contepo
Complicated urinary tract infections (cUTI)
CRL
CRL
CRL issued April 30, 2019. Further CRL received June 19, 2020.
Lefamulin - Intravenous and Oral
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)
Approved
Approved
FDA approval announced August 19, 2019.

Latest News

  1. -- Findings underscore potential of XENLETA as a first-in-class pleuromutilin antibiotic for the IV and oral treatment of CABP in adults, including older patients with comorbidities who are at risk of poor outcomes --

    -- Pooled analysis of data by age group from pivotal LEAP 1 and LEAP 2 Phase 3 clinical trials to be presented at CHEST Annual Meeting 2020 --

    DUBLIN, Ireland, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ:NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that in a post-hoc analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 trials by age, XENLETA™ (lefamulin) demonstrated…

    -- Findings underscore potential of XENLETA as a first-in-class pleuromutilin antibiotic for the IV and oral treatment of CABP in adults, including older patients with comorbidities who are at risk of poor outcomes --

    -- Pooled analysis of data by age group from pivotal LEAP 1 and LEAP 2 Phase 3 clinical trials to be presented at CHEST Annual Meeting 2020 --

    DUBLIN, Ireland, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ:NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that in a post-hoc analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 trials by age, XENLETA™ (lefamulin) demonstrated consistently high efficacy and similar safety and tolerability profiles across all patient groups, including adults over 65 years of age who are at higher risk of morbidity and mortality from CABP. CABP is the most common cause of infectious death in U.S. adults age 65 and older. Results of the pooled analysis from the pivotal Phase 3 clinical trials of XENLETA will be presented at the virtual CHEST Annual Meeting, October 18-21, 2020.

    "People of advanced age are especially at risk for developing CABP as a result of a weakened immune system and age-related comorbidities that increases the chances of hospitalization and CABP-related complications leading to functional impairment and/or mortality," said Jennifer Schranz, MD, Chief Medical Officer of Nabriva. "Our post-hoc analysis highlights that XENLETA provides a safe and effective empiric monotherapy alternative to fluoroquinolones for treatment of CABP in patients with advanced age and comorbidities."

    In this pooled analysis of 1289 patients from LEAP 1 and LEAP 2 by age group, including adults ages 18-64, 65-74, 75-84, and 85 and older, 40 percent of the overall pooled patient population was over 65 years of age. Compared to younger patients, patients 65 years of age and older had higher pneumonia severity scores and were more likely to have renal impairment, cardiac disease, hypertension, diabetes or asthma/COPD. The analysis showed that early clinical response (ECR) and investigator assessment of clinical response (IACR) at the Test of Cure (TOC) for XENLETA were high (approximately 90%) and similar to that of moxifloxacin, a current standard of care fluoroquinolone for CABP, for all age groups. The adverse event profile and study drug discontinuation rates were similar across all age groups.

    XENLETA is a first-in-class systemic pleuromutilin antibiotic with a unique mechanism of action that attacks the difficult-to-treat pathogens in CABP and addresses the challenges of antibiotic resistance. It is approved by the FDA for the IV and oral treatment of CABP in adults. Full results of the pooled analyses presented at the virtual CHEST Annual Meeting can be found here: https://www.nabriva.com/Portals/0/Nabriva/Posters/CHEST2020/LEF3067_CHEST%202020%20ePoster_LEAP%201%202%20Efficacy%20Safety%20by%20Age.pdf

    About CABP

    Pneumonia is an infection of the lung that can be serious and fatal, especially among older adult patients with comorbidities. There are approximately five million cases of pneumonia in the U.S. each year, and pneumonia is the fifth leading cause of hospitalization and one of the leading causes of infection-related death. Streptococcus pneumoniae is the most common cause of bacterial pneumonia in the U.S. According to recent data from the SENTRY Antimicrobial Surveillance Program, in the U.S., approximately 30 to 60 percent of S. pneumoniae, depending on region, are macrolide resistant. In addition to macrolides, fluoroquinolones are another common treatment option for CABP. This broad-spectrum class is an effective option; however, fluoroquinolones carry boxed warnings for several significant safety concerns.

    About XENLETA

    XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA's binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. For more information, please visit www.xenleta.com.

    About Nabriva Therapeutics plc

    Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin), the first pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing Contepo™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories. For more information, please visit https://www.nabriva.com.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

    USAGE

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.

    XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.

    WARNINGS AND PRECAUTIONS

    XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.

    Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

    Clostridium-difficile associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

    ADVERSE REACTIONS

    The most common adverse reactions (≥2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.

    USE IN SPECIFIC POPULATIONS

    In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.

    Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA.

    Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.

    Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.

    XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.

    To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see Full Prescribing Information for XENLETA.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its ability to successfully launch and commercialize XENLETA for the treatment of CABP, including the availability of and ease of access to XENLETA through major U.S. specialty distributors, marketing exclusivity and patent protection for XENLETA, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans for making lefamulin available in China, plans to pursue research and development of other product candidates, expectations regarding the ability of customers to satisfy demand for XENLETA with their existing inventory, the sufficiency of Nabriva Therapeutics' existing cash resources and its expectations regarding anticipated revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations 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: Nabriva Therapeutics' ability to successfully implement its commercialization plans for XENLETA and whether market demand for XENLETA is consistent with its expectations, Nabriva Therapeutics' ability to build and maintain a sales force for XENLETA, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, 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 studies 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 CONTEPO for the treatment of cUTI, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics' annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics' views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics 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 Therapeutics' views as of any date subsequent to the date of this press release.

    CONTACTS:

    For Investors

    Gary Sender

    Nabriva Therapeutics plc

    For Media

    Mike Beyer

    Sam Brown Inc.



    312-961-2502

    Primary Logo

    View Full Article Hide Full Article
  2. -NTAP designation highlights need for novel antibiotics to fight drug-resistant infections and advance antimicrobial stewardship

    -CONTEPO first Qualified Infectious Disease Product to receive NTAP conditional approval prior to FDA approval

    DUBLIN, Ireland, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ:NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for XENLETA (lefamulin) for injection when administered in the hospital inpatient setting. XENLETA is a pleuromutilin antibacterial indicated for the…

    -NTAP designation highlights need for novel antibiotics to fight drug-resistant infections and advance antimicrobial stewardship

    -CONTEPO first Qualified Infectious Disease Product to receive NTAP conditional approval prior to FDA approval

    DUBLIN, Ireland, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ:NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for XENLETA (lefamulin) for injection when administered in the hospital inpatient setting. XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP). Both the IV and oral formulations of XENLETA were granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the FDA.

    Beginning on October 1, 2020, CMS will provide an additional maximum payment of $1,275.75 for XENLETA when used in the inpatient hospital setting for fiscal year 2021. The U.S. Food and Drug Administration (FDA) approved the IV and oral versions of XENLETA for the treatment of adult patients with CABP in August 2019.

    Nabriva also announced today that CMS has granted an NTAP for CONTEPO (fosfomycin), making CONTEPO the first QIDP to be granted conditional NTAP approval prior to receiving FDA approval. CONTEPO was granted QIDP and Fast Track Designation by the FDA for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis. If CONTEPO receives FDA approval prior to July 1, 2021, the maximum add-on payment for a case involving the administration of CONTEPO is $2,343.75 for fiscal year 2021, which would become effective beginning in the first quarter after FDA approval is granted.

    The NTAP will provide hospitals with a payment on top of the standard-of-care Diagnostic Related Group (DRG) reimbursement. This additional payment is provided to offset some of the costs of new drugs and devices when certain criteria are met. For the fiscal year 2021, add-on payments for QIDPs are limited to the lesser of 75 percent of the average cost of the product, or 75 percent of the amount by which the costs of the case exceeds the standard DRG payment. NTAP designation lasts no more than three years for a specific indication.

    "The NTAP designation highlights the potential of XENLETA and CONTEPO to address the urgent need for novel, first-in-class antibiotics for patients fighting drug-resistant infections," said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. "Importantly, the decision to grant conditional NTAP approval to CONTEPO is unprecedented and we believe should enable more rapid access to this innovative antimicrobial following FDA approval. We applaud CMS for taking the initial policy steps that will enable patients in need to be prescribed innovative antibacterial agents and help reverse the consequences of antimicrobial resistance."

    The NTAP program for antimicrobial resistance (AMR) is intended to encourage the use of new medical technologies in the hospital inpatient setting and help reduce barriers to antibiotic innovation.

    About XENLETA

    XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA's binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting.

    About CONTEPO

    CONTEPO (fosfomycin) for injection is a novel, potentially first-in-class in the United States, intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant (MDR) strains such as extended spectrum β-lactamase (ESBL)-producing Enterobacteriaceae. IV fosfomycin has been approved for a number of indications and utilized for over 45 years outside the U.S. to treat a variety of infections, including cUTIs and other serious bacterial infections.

    About Nabriva Therapeutics plc

    Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA™ (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTIs), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories. For more information, please visit www.nabriva.com.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

    USAGE

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.

    XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.

    WARNINGS AND PRECAUTIONS

    XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.

    Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

    Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

    ADVERSE REACTIONS

    The most common adverse reactions (≥2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.

    USE IN SPECIFIC POPULATIONS

    In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.

    Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers.

    Monitor for reduced efficacy of XENLETA.

    Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.

    Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.

    XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.

    To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or the FDA at 1-800-FDA-1088 or https://www.fda.gov/safety/medwatch.

    Please see Full Prescribing Information for XENLETA. For more information, please see: www.xenleta.com

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its ability to successfully launch and commercialize XENLETA for the treatment of CABP, including the availability of and ease of access to XENLETA through major U.S. specialty distributors, marketing exclusivity and patent protection for XENLETA, the distribution and promotion of SIVEXTRO for the treatment of ABSSSI, the development of CONTEPO for Complicated Urinary Tract Infections (cUTI), the ability to secure and deploy a commercial sales force, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP, SIVEXTRO for ABSSSI and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans for making lefamulin available in the European Union, Canada and China, plans to pursue research and development of other product candidates, expectations regarding the ability of customers to satisfy demand for XENLETA with their existing inventory, expectations regarding the impact of the interruptions resulting from COVID-19 on its business,  the sufficiency of Nabriva Therapeutics' existing cash resources and its expectations regarding anticipated revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations 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: Nabriva Therapeutics' ability to successfully implement its commercialization plans for XENLETA and SIVEXTRO and whether market demand for XENLETA and SIVEXTRO is consistent with its expectations, Nabriva Therapeutics' ability to build and maintain a sales force for XENLETA and SIVEXTRO, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, 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 studies 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 CONTEPO for the treatment of cUTI, the extent of business interruptions resulting from the infection causing the COVID-19 outbreak or similar public health crises, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics' annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics' views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics 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 Therapeutics' views as of any date subsequent to the date of this press release.

    CONTACTS:

    For Investors

    Gary Sender

    Nabriva Therapeutics plc

     

    For Media

    Mike Beyer

    Sam Brown Inc.

     

    312-961-2502

    Primary Logo

    View Full Article Hide Full Article
  3. DUBLIN, Ireland, Aug. 31, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ:NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that management will participate in two upcoming investor conferences in September.

    • H.C. Wainwright 22nd Annual Global Investment Conference being held virtually on Monday, September 14, 2020 at 4:00 p.m. ET. Ted Schroeder, Chief Executive Officer at Nabriva, will provide a company overview and business update.
       
    • Management will host investor meetings during the Morgan Stanley Virtual Global Healthcare Conference on Wednesday, September 16, 2020.

    The presentation at H.C. Wainwright will be webcast…

    DUBLIN, Ireland, Aug. 31, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ:NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that management will participate in two upcoming investor conferences in September.

    • H.C. Wainwright 22nd Annual Global Investment Conference being held virtually on Monday, September 14, 2020 at 4:00 p.m. ET. Ted Schroeder, Chief Executive Officer at Nabriva, will provide a company overview and business update.

       
    • Management will host investor meetings during the Morgan Stanley Virtual Global Healthcare Conference on Wednesday, September 16, 2020.

    The presentation at H.C. Wainwright will be webcast live and may be accessed by visiting the "Investors" section of the Company's website under the "Events and Presentations" tab at www.nabriva.com. A replay of the webcast will be available for 90 days.

    About Nabriva Therapeutics plc

    Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its ability to successfully launch and commercialize XENLETA for the treatment of CABP, including the availability of and ease of access to XENLETA through major U.S. specialty distributors, marketing exclusivity and patent protection for XENLETA, the distribution and promotion of SIVEXTRO for the treatment of ABSSSI, the development of CONTEPO for Complicated Urinary Tract Infections (cUTI), the ability to secure and deploy a commercial sales force, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP, SIVEXTRO for ABSSI and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans for making lefamulin available in the European Union, Canada and China, plans to pursue research and development of other product candidates, expectations regarding the ability of customers to satisfy demand for XENLETA with their existing inventory, expectations regarding the impact of the interruptions resulting from COVID-19 on its business,  the sufficiency of Nabriva Therapeutics' existing cash resources and its expectations regarding anticipated revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations 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: Nabriva Therapeutics' ability to successfully implement its commercialization plans for XENLETA and SIVEXTRO and whether market demand for XENLETA and SIVEXTRO is consistent with its expectations, Nabriva Therapeutics' ability to build and maintain a sales force for XENLETA and SIVEXTRO, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, 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 studies 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 CONTEPO for the treatment of cUTI, the extent of business interruptions resulting from the infection causing the COVID-19 outbreak or similar public health crises, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics' annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics' views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics 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 Therapeutics' views as of any date subsequent to the date of this press release.

    CONTACTS:

    For Investors

    Gary Sender

    Nabriva Therapeutics plc

    For Media

    Mike Beyer

    Sam Brown Inc.



    312-961-2502

     

    Primary Logo

    View Full Article Hide Full Article
  4. -SIVEXTRO® adds revenue generating product creating additional scale and synergies-

    -Relaunch of XENLETA® and SIVEXTRO planned with targeted in-person promotion-

    -Conference call today at 4:30 p.m. Eastern Time-

    DUBLIN, Ireland, Aug. 06, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ:NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced its financial results for the three months ended June 30, 2020 and provided a corporate update.

    "We have been actively building the foundation for relaunching our commercial efforts in the community.  Nabriva now has an experienced contract sales partner and the opportunity…

    -SIVEXTRO® adds revenue generating product creating additional scale and synergies-

    -Relaunch of XENLETA® and SIVEXTRO planned with targeted in-person promotion-

    -Conference call today at 4:30 p.m. Eastern Time-

    DUBLIN, Ireland, Aug. 06, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ:NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced its financial results for the three months ended June 30, 2020 and provided a corporate update.

    "We have been actively building the foundation for relaunching our commercial efforts in the community.  Nabriva now has an experienced contract sales partner and the opportunity to promote and distribute an important new revenue-generating product in SIVEXTRO.  Adding SIVEXTRO to our portfolio is an important component of our strategy to actively pursue business development and licensing opportunities that have a highly complementary customer base and leverage Nabriva's capabilities," said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. "We recently secured an agreement with Amplity Health, a leading pharmaceutical contract commercial organization, to provide Nabriva the ability to build a flexible and efficient sales infrastructure to leverage brand awareness for both XENLETA and SIVEXTRO. We believe Nabriva now has a solid foundation in place to educate health care providers about the benefits of these two important anti-infective treatment options for their patients. Our managed care presence continues to strengthen in the U.S. and XENLETA is now accessible to more than 225 million covered lives. This, coupled with our partnership with WEP Clinical and recent approvals for XENLETA in the European Union and Canada, have enhanced our ability to provide access for patients despite the challenges presented by the ongoing global pandemic."

    CORPORATE AND DEVELOPMENT UPDATES

    • On July 28, 2020, Nabriva announced that the European Commission (EC) approved the marketing authorization application for XENLETA (lefamulin) for the treatment of community-acquired pneumonia (CAP) in adults in the European Union following a review by the European Medicines Agency.

       
    • On July 16, 2020, Nabriva announced that Sunovion Pharmaceuticals Canada Inc., received approval from Health Canada to market oral and intravenous (IV) formulations of XENLETA for the treatment of community-acquired pneumonia in adults in Canada. Nabriva entered into a license and commercialization agreement in March 2019 with Sunovion Pharmaceuticals Canada Inc. for XENLETA in Canada. 

       
    • On July 15, 2020, Nabriva announced that it entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories. SIVEXTRO is an oxazolidinone-class antibacterial. In addition, Nabriva engaged Amplity Health, a leading pharmaceutical contract commercial organization, to provide community-based commercial and sales services for SIVEXTRO and XENLETA in the United States.

       
    • On June 30, 2020, Nabriva announced that it had signed an exclusive agreement with WEP Clinical (WEP), a specialist pharmaceutical services company, to supply XENLETA on a named patient or expanded access basis in certain countries outside of the U.S., China and Canada. The Named Patient Program (NPP) is designed to ensure that physicians, contingent on meeting the necessary eligibility criteria and receiving approval, can request IV or oral XENLETA on behalf of patients who live in certain countries where it is not yet available and have an unmet medical need.  

       
    • On June 19, 2020, Nabriva received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for the New Drug Application (NDA) resubmission seeking marketing approval of CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis. Although Nabriva's European contract manufacturing partners were prepared for regulatory authority inspections, the CRL cites observations at its manufacturing partners that could not be resolved due to FDA's inability to conduct onsite inspections because of travel restrictions caused by the COVID-19 pandemic. In general, previously identified product quality and facility inspection related observations at its contract manufacturing partners are required to be satisfactorily resolved before the NDA may be approved. The FDA did not request any new clinical data and did not raise any other concerns with regard to the safety or efficacy of CONTEPO in the CRL. Nabriva plans to request a Type A meeting with the FDA to discuss its plans for completing foreign facility inspections and the appropriate next steps to refile the NDA. CONTEPO has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of serious infections, including cUTIs.

       
    • On May 29, 2020, Nabriva announced that it entered into a definitive agreement with several healthcare-focused institutional investors, including Fidelity Management & Research Company, LLC, to issue and sell ordinary shares and warrants in a registered direct offering priced at-the-market under Nasdaq rules for aggregate gross proceeds of $38.0 million before deducting placement agent fees and other offering expenses payable by Nabriva.

       
    • On April 7, 2020, Nabriva announced it was restructuring its hospital-based commercial sales force and transitioning to a community-based sales force. The restructuring aligns the capabilities of the Company's sales force with its strategic refocus for promoting XENLETA to community health care professionals, the excellent managed care coverage it has secured and its business development strategy to in-license additional community products, resulting in a substantial reduction in expenditures. In the second quarter, Nabriva also reduced commercial, medical affairs and administrative expenses.

       
    • On April 9, 2020, Nabriva received confirmation from the Centers for Medicare and Medicaid Services (CMS) of a preliminary decision to assign permanent product-specific Healthcare Common Procedure Coding System (HCPCS) J-code for XENLETA 150 mg injection. The new billing code, J0691 Injection, became effective July 1, 2020, replaced the C Code, C9054 and enables healthcare providers to list physician-administered drugs on claim forms submitted to CMS to receive proper reimbursement for Medicare-eligible patients.  

       
    • On April 29, 2020, Nabriva received written notice from Nasdaq indicating that, based on the closing bid for the last 30 consecutive business days, the Company was not in compliance with the $1.00 minimum bid price (Bid Price Rule) requirement for continued listing on The Nasdaq Global Select Market. The Notice does not result in the immediate delisting of the Company's ordinary shares from The Nasdaq Global Select Market. Nabriva will have until December 28, 2020 to regain compliance with the Bid Price Rule. To regain compliance, the closing bid price of Nabriva's ordinary shares must be at least $1.00 per share for a minimum of ten consecutive business days on or before December 28, 2020. At its July 29, 2020 Annual General Meeting, Nabriva's shareholders approved a reverse stock split (i.e., a consolidation of share capital under Irish law), subject to and conditional upon the board of directors determining, in its sole discretion, that a reverse stock split is necessary for the Company to comply with the Bid Price Rule, whereby every 10 ordinary shares of $0.01 (nominal value) each in the authorized and unissued and authorized and issued share capital of the Company be consolidated into 1 ordinary share of $0.10 (nominal value) each, and the subsequent reduction in the nominal value of the ordinary shares in the authorized and unissued and authorized and issued share capital of the Company from $0.10 each to $0.01 each. Nabriva's board of directors is evaluating whether a reverse stock split is necessary.

    FINANCIAL RESULTS

    Three Months Ended June 30, 2019 and 2020

    • Revenues were $0.5 million for the three months ended June 30, 2019 and $0.5 million for the three months ended June 30, 2020, primarily due to grant revenues. For the three months ended June 30, 2020 we recorded $0.1 million of product revenue, net of gross-to-net accruals. In addition, we recorded a $0.3 million returns reserve adjustment for slow moving inventory, representing 50% of XENLETA IV inventory held at our Specialty Distributors, partly offset by a favorable $0.2 million gross-to-net adjustment, resulting in $48 thousand of negative product revenue, net for the three months ended June 30, 2020.

       
    • Research and development expenses decreased by $1.6 million from $8.1 million for the three months ended June 30, 2019 to $6.5 million for the three months ended June 30, 2020. The decrease was primarily due to a $0.9 million decrease in staff costs, a $0.5 million decrease in research consulting fees, and a $0.1 million decrease in travel costs.

       
    • Selling, general and administrative expense decreased by $5.3 million from $13.4 million for the three months ended June 30, 2019 to $8.1 million for the three months ended June 30, 2020. The decrease was primarily due to a $4.5 million decrease in advisory and external consultancy expenses primarily related to pre-commercialization activities and professional service fees in 2019, a $0.5 million decrease in staff costs due to the termination of employees, a $0.4 million decrease in travel expenses and a $0.4 million decrease in infrastructure costs, partly offset by a $0.4 million increase in legal fees.

    Six Months Ended June 30, 2019 and 2020

    • Revenues decreased by $1.0 million from $2.2 million for the six months ended June 30, 2019 to $1.3 million for the six months ended June 30, 2020, primarily due a $0.8 million decrease in collaboration revenue and a $0.2 million decrease in grant revenue, offset by a $0.1 million increase in product revenue, net associated with the launch of XENLETA. For the six months ended June 30, 2020, we recorded $0.2 million of product revenue, net of gross-to-net accruals. In addition, we recorded a $0.3 million returns reserve adjustment for slow moving inventory, representing 50% of XENLETA IV inventory held at our Specialty Distributors, partly offset by a favorable $0.2 million gross-to-net adjustment, resulting in $0.1 million product revenue, net for the six months ended June 30, 2020.

       
    • Research and development expenses decreased by $4.2 million from $15.6 million for the six months ended June 30, 2019 to $11.4 million for the six months ended June 30, 2020. The decrease was primarily due to a $3.0 million decrease in research materials and purchased services related to the development of XENLETA, a $1.7 million decrease in research consulting fees, a $1.8 million decrease in staff costs and a $0.2 million decrease in travel and infrastructure costs, partly offset by a $2.6 million refund of NDA filing fees for our product candidate, CONTEPO, in 2019.

       
    • Selling, general and administrative expense decreased by $2.7 million from $26.8 million for the six months ended June 30, 2019 to $24.1 million for the six months ended June 30, 2020. The decrease was primarily due to a $5.2 million decrease in advisory and external consultancy expenses primarily related to pre-commercialization activities and professional service fees in 2019, a $0.7 million decrease in stock-based compensation expense and a $0.1 million decrease in other corporate costs, partly offset by a $0.3 million increase in legal fees and a $3.0 million increase in staff costs due to the addition of employees, prior to our reduction in sales force in April 2020.

       
    • As previously disclosed, Nabriva's distribution partners continue to primarily utilize their existing inventory to satisfy product demand, which in turn impacted sales in the second quarter of 2020. In light of the COVID-19 pandemic, the associated disruption to the healthcare delivery and the uncertainty of resuming full direct physician medical education and promotion, future sales amounts in 2020 are uncertain.

       
    • As of June 30, 2020, Nabriva Therapeutics had $49.7 million in cash and cash equivalents, compared to $86.0 million as of December 31, 2019. 

       
    • Based on its current operating plans, the Company expects that its existing cash resources will be sufficient to enable Nabriva to fund its operating expenses, debt service obligations and capital expenditure requirements into the first quarter of 2021. This estimate assumes, among other things, that Nabriva remains in compliance with the covenants under its Loan Agreement.

    Please refer to our Annual Report on Forms 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, which are filed with the U.S. Securities and Exchange Commission, for additional information regarding the Company's business and financial results.   

    Company to Host Conference Call

    Nabriva's management will host a conference call today at 4:30 p.m. ET to discuss the financial results and recent corporate highlights. The dial-in number for the conference call is (866) 811-8671 for domestic participants and (409) 981-0874 for international participants, with Conference ID #4007639. A live webcast of the conference call can be accessed through the "Investors" tab on the Nabriva Therapeutics website at www.nabriva.com. A replay will be available on this website shortly after conclusion of the event for 90 days.

    About Nabriva Therapeutics plc

    Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories.

    About XENLETA

    XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA's binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP.  In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA included diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. For more information, please visit www.xenleta.com.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

    USAGE

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.

    XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.

    WARNINGS AND PRECAUTIONS

    XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.

    Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

    Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

    ADVERSE REACTIONS

    The most common adverse reactions (≥2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.

    USE IN SPECIFIC POPULATIONS

    In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.

    Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA.

    Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.

    Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.

    XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.

    To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or https://www.fda.gov/safety/medwatch.

    Please see Full Prescribing Information for XENLETA.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its ability to successfully launch and commercialize XENLETA for the treatment of CABP, including the availability of and ease of access to XENLETA through major U.S. specialty distributors, marketing exclusivity and patent protection for XENLETA, the distribution and promotion of SIVEXTRO for the treatment of ABSSSI, the development of CONTEPO for Complicated Urinary Tract Infections (cUTI), the ability to secure and deploy a commercial sales force, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP, SIVEXTRO for ABSSSI and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans for making lefamulin available in the European Union, Canada and China, plans to pursue research and development of other product candidates, expectations regarding the ability of customers to satisfy demand for XENLETA with their existing inventory, expectations regarding the impact of the interruptions resulting from COVID-19 on its business,  the sufficiency of Nabriva Therapeutics' existing cash resources and its expectations regarding anticipated revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations 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: Nabriva Therapeutics' ability to successfully implement its commercialization plans for XENLETA and SIVEXTRO and whether market demand for XENLETA and SIVEXTRO is consistent with its expectations, Nabriva Therapeutics' ability to build and maintain a sales force for XENLETA and SIVEXTRO, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, 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 studies 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 CONTEPO for the treatment of cUTI, the extent of business interruptions resulting from the infection causing the COVID-19 outbreak or similar public health crises, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics' annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics' views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics 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 Therapeutics' views as of any date subsequent to the date of this press release.

    CONTACTS:

    For Investors

    Gary Sender

    Nabriva Therapeutics plc

    For Media

    Mike Beyer

    Sam Brown Inc.



    312-961-2502

     
    Consolidated Balance Sheets (unaudited)
           
      As of As of
    (in thousands, except share data) December 31, 2019 June 30, 2020
    Assets      
    Current assets:      
    Cash and cash equivalents $86,019  $49,660 
    Restricted cash  392   229 
    Short-term investments  175   175 
    Accounts receivable, net and other receivables  2,744   3,228 
    Inventory  682   5,196 
    Prepaid expenses  1,158   3,921 
    Total current assets  91,170   62,409 
    Property, plant and equipment, net  2,474   2,176 
    Intangible assets, net  91   97 
    Long-term receivables  378   368 
    Total assets $ 94,113  $65,050 
    Liabilities and equity      
    Current liabilities:      
    Accounts payable $4,673  $2,620 
    Accrued expense and other current liabilities  11,966   8,376 
    Total current liabilities  16,639   10,996 
    Non-current liabilities      
    Long-term debt  34,502   7,477 
    Other non-current liabilities  1,698   2,116 
    Total non-current liabilities  36,200   9,593 
    Total liabilities   52,839   20,589 
    Stockholders' Equity:      
    Ordinary shares, nominal value $0.01, 1,000,000,000 ordinary shares authorized at June 30, 2020; 94,545,116 and 142,965,483 issued and outstanding at December 31, 2019 and June 30, 2020, respectively  945   1,430 
    Preferred shares, par value $0.01, 100,000,000 shares authorized at June 30, 2020; None issued and outstanding      
    Additional paid in capital  517,044   558,446 
    Accumulated other comprehensive income  27   27 
    Accumulated deficit  (476,742)  (515,442)
    Total stockholders' equity   41,274   44,461 
    Total liabilities and stockholders' equity $ 94,113  $65,050 



     
    Consolidated Statements of Operations (unaudited)
                 
      Three Months Ended  Six Months Ended
      June 30,  June 30, 
    (in thousands, except share and per share data) 2019 2020 2019 2020
    Revenues:            
    Product revenue, net $   (48) $  $108 
    Collaboration revenue     7   1,000   152 
    Research premium and grant revenue  525   528   1,228   1,016 
    Total revenue  525   487   2,228   1,276 
    Operating expenses:            
    Cost of product sales     (368)     (376)
    Research and development expenses  (8,074)  (6,500)  (15,612)  (11,444)
    Selling, general and administrative expenses  (13,427)  (8,072)  (26,836)  (24,097)
    Total operating expenses  (21,501)  (14,940)  (42,448)  (35,917)
    Loss from operations   (20,976)  (14,453)   (40,220)  (34,641)
    Other income (expense):            
    Other income (expense), net  56   (634)  126   164 
    Interest income  72   16   82   80 
    Interest expense  (904)  (251)  (1,803)  (1,275)
    Loss on extinguishment of debt           (2,757)
    Loss before income taxes   (21,752)  (15,322)   (41,815)  (38,429)
    Income tax benefit (expense)  45   (119)  (109)  (271)
    Net loss $ (21,707)  (15,441) $ (41,924) $(38,700)
                 
    Loss per share            
    Basic and diluted ($ per share) $(0.30) $(0.14) $(0.59) $(0.37)
    Weighted average number of shares:            
    Basic and diluted  72,526,441   112,778,258   70,624,583   103,686,706 



     
    Condensed Consolidated Statements of Cash Flows

     (unaudited)
     
      Six Months Ended 

    June 30,
    (in thousands) 2019 2020
    Net cash provided by (used in):    
    Operating activities $(41,670) $(45,372)
    Investing activities (57) (248)
    Financing activities 13,428  9,168 
    Effects of foreign currency translation on cash and cash equivalents 40  (70)
    Net decrease in cash and cash equivalents (28,259) (36,522)
    Cash and cash equivalents and restricted cash at beginning of period 102,003  86,411 
    Cash and cash equivalents and restricted cash at end of period $73,744  $49,889 
         



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  5. DUBLIN, Ireland, Aug. 03, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ:NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it will report its second quarter financial results after the close of the U.S. financial markets on Thursday, August 6, 2020. Nabriva's management will host a conference call at 4:30 p.m. ET to discuss the financial results and recent corporate highlights.

    The dial-in number for the conference call is 866-811-8671 for domestic participants and 409-981-0874 for international participants, with Conference ID #4007639. A live webcast of the conference call can be accessed through the "Investors

    DUBLIN, Ireland, Aug. 03, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ:NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it will report its second quarter financial results after the close of the U.S. financial markets on Thursday, August 6, 2020. Nabriva's management will host a conference call at 4:30 p.m. ET to discuss the financial results and recent corporate highlights.

    The dial-in number for the conference call is 866-811-8671 for domestic participants and 409-981-0874 for international participants, with Conference ID #4007639. A live webcast of the conference call can be accessed through the "Investors" tab on the Nabriva Therapeutics website at www.nabriva.com.  A replay will be available on this website shortly after conclusion of the event for 90 days.

    About Nabriva Therapeutics plc

    Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about Nabriva Therapeutics' ability to successfully launch and commercialize XENLETA for the treatment of CABP or CAP, including the availability of and ease of access to XENLETA in Europe and through major U.S. specialty distributors, marketing exclusivity and patent protection for XENLETA, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP or CAP and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans to pursue research and development of other product candidates, the sufficiency of Nabriva Therapeutics' existing cash resources and its expectations regarding anticipated revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations 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: Nabriva Therapeutics' ability to successfully implement its commercialization plans for XENLETA and whether market demand for XENLETA is consistent with its expectations, Nabriva Therapeutics' ability to build and maintain a sales force for XENLETA, the content and timing of decisions made by the European Commission, the U.S. Food and Drug Administration and other regulatory authorities, 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 studies 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 CONTEPO for the treatment of cUTI, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics' annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics' views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics 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 Therapeutics' views as of any date subsequent to the date of this press release.

    CONTACTS:

    For Investors

    Gary Sender

    Nabriva Therapeutics plc

    For Media

    Mike Beyer

    Sam Brown Inc.

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