8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of Earliest Event Reported):  September 18, 2017

NABRIVA THERAPEUTICS PLC

(Exact name of registrant as specified in its charter)

Ireland	001-37558	Not Applicable
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

25-28 North Wall Quay, IFSC, Dublin 1, Ireland	Not Applicable
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (610) 816-6640

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  x

Item 7.01.  Regulation FD Disclosure.

On September 18, 2017, Nabriva Therapeutics plc (the “Company”) announced topline results from its first Phase 3 clinical trial of lefamulin for the treatment of community-acquired bacterial pneumonia, which is also referred to as the LEAP 1 trial.

The Company will host a conference call to discuss the topline results of the LEAP 1 trial on Monday, September 18, 2017 at 8:30 AM Eastern Time, and a live webcast of the call will be available through the investor relations section of the Company’s website.

The slide presentation to be used by the Company during the call is attached hereto as Exhibit 99.1 and incorporated herein by reference. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01.  Other Events.

The press release announcing the topline results from the LEAP 1 trial is attached hereto as Exhibit 99.2 and incorporated herein by reference.

Item 9.01.             Financial Statements and Exhibits.

(d)  Exhibits.

Exhibit No.	Description
99.1	LEAP 1 Presentation dated September 18, 2017.
99.2	Press Release dated September 18, 2017.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	NABRIVA THERAPEUTICS PLC
Date: September 18, 2017	By:	/s/ Colin Broom
		Colin Broom, M.D.
		Chief Executive Officer

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EX-99.1

Exhibit 99.1

Lefamulin Evaluation Against Pneumonia (LEAP 1) Phase 3 Topline Results September 18, 2017

Any statements in this presentation 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 Nabriva’s ongoing Phase 3 clinical trial 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, whether results of Nabriva’s first Phase 3 clinical trial of lefamulin will be indicative of the results for its second Phase 3 clinical trial of lefamulin, 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 and quarterly reports on file 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 presentation. Safe Harbor and Disclaimer

Significant medical need for a new treatment of CABP due to increasing bacterial resistance and high morbidity and mortality Lefamulin in two global, pivotal Phase 3 trials for moderate-to-severe CABP with topline data received in September 2017 and expected for LEAP 2 in the spring of 2018 Investing in pre-commercial activities to maximize U.S. commercial potential and evaluating ex-U.S. partner(s) 2017- A Transformational Year for Nabriva Building a Fully Integrated Anti-Infectives Company Expert team advancing pleuromutilins, a new class of antibiotics, for systemic (IV and oral) use in humans

Pneumonia: A Leading Cause of Morbidity, Mortality and Cost 5-6MM Approximately CABP cases annually Mortality rate for admitted patients Mortality rate for those who require admission to ICU Leading cause of death ~15% ~25 - 30% ~8th Sources: File TM.J Manag Care Pharm.2009;15(2 Suppl):S5-S11 - Fingar K, Washington R. Trends in hospital readmissions for four high-volume conditions, 2009-2013: Statistical Brief #196. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, MD: Agency for Healthcare Research and Quality; November 2015. http//www.hcup-us.ahrq.gov/reports/statbriefs/sb196-Readmissions-Trends-High-Volume-Conditions.pdf. Accessed February 23, 2016. File TM Jr, Marrie TJ. Burden of community-acquired pneumonia in North American adults. Postgrad Med. 2010;122:130–41. Fingar K, Washington R. Trends in Hospital Readmissions for Four High-Volume Conditions, 2009-2013: Statistical Brief #196. Healthcare Cost and Utilization project (HCUP) Statistical briefs. Rockville, MD: Agency for Healthcare Research and Quality; November 2015 ~$17B Direct hospitalization costs of CAP In 2013, the pneumonia diagnosis was ranked #1 for total hospitalizations and #3 for readmission rate

Lefamulin A site P site PTC of the 23S rRNA of the large ribosomal subunit Pleuromutilins Represent a New Class of Antibiotics for Systemic Human Use Lefamulin: Discovered and developed by Nabriva Therapeutics Novel mechanism of action with four distinctive binding sites in highly conserved core of the ribosomal peptidyl transferase center (PTC) Targeted anti-bacterial spectrum against respiratory pathogens (Gram-positive, Gram-negative and atypical bacteria) Minimal effect on off-target GI flora such as B. fragilis, E. coli and E. faecalis Low propensity for development of bacterial resistance and lack of cross-resistance with other antibiotic classes, based on in vitro studies lefamulin

LEAP 1 Trial Design and Demographics

LEAP 1 Phase 3 Trial Design IV Initiation with Option for Switch to Oral Administration Lefamulin (± Placebo) Moxifloxacin (± Linezolid) Informed Consent & Baseline Assessments Randomization Early Clinical Response Assessment (96 +/- 24 hrs After 1st Dose) End of Treatment Within 2 Days After Last Dose Test of Cure (TOC) 5-10 Days After Last Dose Late Follow Up 30 +/-3 Days After 1st Dose >3 days of IV therapy Option to change to PO based on predefined signs of improvement and investigator discretion Follow Up Study Drug Administration Enrollment: Must Dose Within 24 h

LEAP 1 Phase 3 Trial Design FDA and EMA Primary Endpoints At 72 to 120 hours after first dose of study drug: Improvement in > 2 of 4 CABP signs/symptoms No worsening in any CABP signs/symptoms Alive Did not receive non-study antibacterial therapy for the treatment of CABP Non-inferiority margin 12.5%, >90% power At 5-10 days after the last dose of study drug: Signs/symptoms of CABP have resolved/improved such that no additional antibacterial therapy is administered for the treatment of CABP Non-inferiority margin 10%, 80% power EMA Endpoints: Investigator Assessment of Clinical Response (IACR) at Test of Cure (TOC) mITT and CE-TOC Population FDA Endpoint: Early Clinical Response (ECR) ITT Population

LEAP 1 Phase 3 Trial Design Symptom Assessment for ECR Symptom Absent (0) Mild (1) Moderate (2) Severe (3) Dyspnea Resolution (to pre-CABP baseline) or absence of dyspnea Dyspnea on exertion (e.g., climbing stairs) Dyspnea with normal/routine activities (e.g., walking) Dyspnea at rest or requiring oxygen therapy Cough Resolution (to pre-CABP baseline) or absence of cough Transient, does not interfere with normal activity Frequent, interferes with normal activity or sleep Constant, interferes with most or all activity or sleep Production of purulent sputum Resolution (to pre-CABP baseline) or absence of sputum production Sputum production rarely causes difficulty or distress Sputum production often causes difficulty or distress Constant difficulty with sputum production Chest pain Resolution or absence of chest pain related to CABP Transient, does not interfere with normal activity Frequent, interferes with normal activity or sleep Constant, interferes with most or all activity or sleep

LEAP 1 Phase 3 Trial Populations and Disposition High Patient Completion and Microbiological Isolate Recovery Rates Category Lefamulin Moxifloxacin (±linezolid) TOTAL All Randomized 276 275 551 Modified ITT (mITT) 273 (98.9%) 273 (99.3%) 546 (99.1%) Clinically Evaluable-Test of Cure (CE-TOC) 236 (85.5%) 245 (89.1%) 481 (87.3%) Microbiological ITT (microITT) 160 (58.0%) 159 (57.8%) 319 (57.9%) Completed Study 249 (90.2%) 256 (93.1%) 505 (91.7%) Completed ECR Assessment 267 (96.7%) 261 (94.9%) 528 (95.8%) Completed TOC Assessment 260 (94.2%) 264 (96.0%) 524 (95.1%)

Category Lefamulin Moxifloxacin (±linezolid) TOTAL Age (Years; Mean) 61.0 59.6 60.3 <65 years 144 (52.2%) 167 (60.7%) 311 (56.4%) 65-74 74 (26.8%) 66 (24.0%) 140 (25.4%) >75 58 (21.0%) 42 (15.3%) 100 (18.1%) Gender Male 170 (61.6%) 160 (58.2%) 330 (59.9%) BMI (kg/m2) (Mean) 26.48 26.33 26.40 Race (White) 239 (86.6%) 239 (86.9%) 478 (86.8%) Renal Status Severe impairment (CrCl <30 ml/min) 3 (1.1%) 3 (1.1%) 6 (1.1%) Moderate impairment (CrCl 30-60 ml/min) 61 (22.1%) 62 (22.5%) 123 (22.3%) Mild impairment (CrCl 60-<90 ml/min) 89 (32.2%) 74 (26.9%) 163 (29.6%) Normal function (CrCl >90 ml/min) 121 (43.8%) 135 (49.1%) 256 (46.5%) LEAP 1 Phase 3 Trial ITT Population Balanced Demographics Between Treatment Groups

LEAP 1 Phase 3 Trial PORT Risk Classification: ITT Population Moderate to Severe Pneumonia Patients PORT Class Lefamulin Moxifloxacin (±linezolid) TOTAL II 0 1 (0.4%) 1 (0.2%) III 196 (71.0%) 201 (73.1%) 397 (72.1%) IV 76 (27.5%) 70 (25.5%) 146 (26.5%) V 4 (1.4%) 3 (1.1%) 7 (1.3%)

LEAP 1 Trial Efficacy Results

High Response Rates in Both Arms LEAP 1 Trial Efficacy Results Lefamulin Meets FDA Primary Endpoint of ECR Percent Responders Delta (95% CI) -2.9 (-8.5, 2.8) 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% ECR 87.3% 90.2% Lefamulin Moxifloxacin (±linezolid)

EMA Primary Endpoints: IACR in CE and mITT at TOC LEAP 1 Trial Efficacy Results Lefamulin Meets EMA Primary Endpoints Percent Responders Delta (95% CI) -2.5 (-8.4, 3.4) Delta (95% CI) -2.6 (-8.9, 3.9) 0% 20% 40% 60% 80% 100% IACR CE - TOC IACR mITT 86.9% 81.7% 89.4% 84.2% Lefamulin Moxifloxacin (±linezolid)

ECR by PORT Risk Classification: ITT Population Lefamulin Demonstrated High Response Rates Across All Severities of CABP PORT Class Lefamulin Moxifloxacin (±linezolid) Treatment Difference (95% CI) II 0 1/1 (100%) -- III 175/196 (89.3%) 187/201 (93.0%) -3.7 (-9.8, 2.3) IV 63/76 (82.9%) 57/70 (81.4%) 1.5 (-12.3, 15.3) V 3/4 (75%) 3/3 (100%) -25.0 (-96.6, 46.6)

ECR by Baseline Pathogen – Typical Pathogens [micro ITT] Lefamulin Demonstrated High Response Rate Across All of the Most Common Causes of CABP Lefamulin Moxifloxacin (±linezolid) Microbiological ITT (microITT) N = 160 (58.0%) N = 159 (57.8%) Baseline Pathogen ECR (%) ECR (%) Gram Positive S. pneumoniae (SP) 82/93 88.2% 91/97 93.8% Penicillin-Susceptible SP (PSSP) 17/21 81.0% 16/18 88.9% Penicillin-Intermediate SP (PISP) 5/5 100% 2/2 100% Penicillin-Resistant SP (PRSP) 2/2 100% 2/3 66.7% Multi-Drug-Resistant SP (MDRSP) 6/6 100% 5/6 83.3% Macrolide-Resistant SP (MRSP) 6/6 100% 5/6 83.3% S. aureus 31/32 96.9% 13/13 100%

ECR by Baseline Pathogen – Typical and Atypical Pathogens [micro ITT] High Response Rate Seen Across All of the Most Common Causes of CABP Lefamulin Moxifloxacin (±linezolid) Baseline Pathogen ECR (%) ECR (%) Gram Negative H. influenzae 8/8 100% 6/7 85.7% M. catarrhalis 47/52 90.4% 52/55 94.5% Atypicals M. pneumoniae 16/19 84.2% 18/20 90.0% L. pneumophila 16/18 88.9% 12/14 85.7% C. pneumoniae 10/11 90.9% 18/19 94.7%

LEAP 1 Trial Safety and Tolerability Data

Overview of Adverse Events Low Rates of Discontinuation Observed Patients with at Least One Lefamulin (n=273) Moxifloxacin (±linezolid) (n=273) Adverse Events (AE) 105 (38.5%) 105 (38.5%) Treatment Emergent AE (TEAE) 104 (38.1%) 103 (37.7%) Serious AE (SAE) 19 (7.0%) 13 (4.8%) Related AE 41 (15.0%) 39 (14.3%) Related SAE 3 (1.1%) 1 (0.4%) AE Leading to Discontinuation of Study Drug 8 (2.9%) 12 (4.4%) AE Leading to Withdrawal from Study 5 (1.8%) 11 (4.0%) Deaths 6 (2.2%) 5 (1.8%)

Treatment Emergent Adverse Events of Interest TEAEs in 6.6% and 13.0% of subjects receiving lefamulin and moxifloxacin (±linezolid), respectively No cases of Clostridium difficile infection were reported in either treatment group Diarrhea was observed in 0.7% and 7.7% of subjects receiving lefamulin and moxifloxacin (±linezolid), respectively TEAEs in 0.7% and 1.5% of subjects receiving lefamulin and moxifloxacin (±linezolid), respectively Gastrointestinal System Organ Class (SOC) Hepatobiliary SOC Cardiac Disorders SOC TEAEs in 2.9% and 4.0% of subjects receiving lefamulin and moxifloxacin (±linezolid), respectively

TEAEs > 2% for Study Medication: Safety Population Lefamulin was Well Tolerated with a Lower Incidence of Diarrhea Preferred Term Lefamulin (n=273) Moxifloxacin (±linezolid) (n=273) Hypokalemia 8 (2.9%) 6 (2.2%) Nausea 8 (2.9%) 6 (2.2%) Insomnia 8 (2.9%) 5 (1.8%) Infusion Site Pain 8 (2.9%) 0 (0.0%) Infusion Site Phlebitis 6 (2.2%) 3 (1.1%) ALT Increase 5 (1.8%) 6 (2.2%) Hypertension 2 (0.7%) 6 (2.2%) Diarrhea 2 (0.7%) 21 (7.7%)

Maximum Post Baseline Liver Enzymes: Safety Population Low Incidence of Elevated Liver Function Tests Lab Parameter Lefamulin Moxifloxacin (±linezolid) Any Post Baseline ALT >3xULN 19/268 (7.1%) 17/267 (6.4%) >5xULN 6/268 (2.2%) 5/267 (1.9%) >10xULN 1/268 (0.4%) 0/267 (0.0%) Any Post Baseline AST >3xULN 11/268 (4.1%) 7/267 (2.6%) >5xULN 2/268 (0.7%) 2/267 (0.7%) >10xULN 1/268 (0.4%) 0/267 (0.0%) Any Post Baseline Total Bilirubin >1.5xULN 3/268 (1.1%) 3/267 (1.1%) >2xULN 0/268 (0.0%) 2/267 (0.7%) Any Post Baseline Alkaline Phosphatase >2xULN 5/268 (1.9%) 5/267 (1.9%) No subject met criteria for Hy’s Law

Maximum Post Dose QTcF Changes (Day 3) Parameter Lefamulin Moxifloxacin (±linezolid) Post Dose Increase 30 - 60 msec 12 (4.6%) 14 (5.4%) Post Dose Increase > 60 msec 0 (0.0%) 1 (0.4%) Post Dose Value > 500 msec 1 (0.4%) 1 (0.4%)

LEAP 1 Phase 3 Clinical Trial Highlights Lefamulin is the first anti-bacterial agent of a new class of antibiotics with favorable Phase 3 data in CABP in more than 15 years Lefamulin’s efficacy data - in our first trial treating adults with CABP - was comparable to a gold standard therapy Lefamulin showed a favorable tolerability profile with no unexpected safety signals or evidence of off-target effects Lefamulin IV, with an option to switch to oral administration, met all primary FDA and EMA endpoints of non-inferiority compared to moxifloxacin (±linezolid)

Acknowledgments Patients and families Clinical investigators and their staff Collaborating research organizations We are grateful for the participation and contributions of the following in the LEAP 1 trial: Thomas File, M.D. George Talbot, M.D. Anita Das, Ph. D. The Nabriva Therapeutics team

Lefamulin Addresses the Factors that Increasingly Influence Treatment Choices for CABP *10 days in clinical trials for confirmed MRSA CABP patients 5-7 days IV/PO Monotherapy for Most* Patients Novel Mechanism of Action CABP Targeted Spectrum of Activity Stewardship Guidelines recommend use of targeted antibiotics, not broad spectrum, and shortest effective treatment duration Resistance to many current antibiotics is rising and increases the need for antibiotics with novel mechanisms of action LEFAMULIN IV & Oral Formulations allow the flexibility to switch from any IV treatment and to discharge the patients earlier or avoid hospitalization

Feb 2017 Blinded, interim analysis to confirm LEAP 1 sample size Sept 2017 Topline data from LEAP 1 Phase 3 trial for CABP Anticipated Lefamulin Milestones Spring 2018 Topline data from LEAP 2 Phase 3 trial for CABP 2H 2018 Regulatory filing in US (priority review request to FDA) for CABP

Lefamulin Evaluation Against Pneumonia (LEAP 1) Phase 3 Topline Results September 18, 2017

EX-99.2

Exhibit 99.2

Nabriva Therapeutics Announces Positive Topline Results from Global, Phase 3 Clinical Trial Evaluating IV and Oral Lefamulin for the Treatment of Community-Acquired Bacterial Pneumonia

- Lefamulin met all primary FDA and EMA endpoints with a favorable tolerability profile -

- Conference call and webcast today at 8:30 a.m. EDT to review results -

DUBLIN, Ireland and KING OF PRUSSIA, Pa., September 18, 2017 — Nabriva Therapeutics plc (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 announced positive topline results from the lefamulin evaluation against pneumonia (LEAP 1) trial, which evaluated the safety and efficacy of intravenous (IV) to oral lefamulin in patients with community-acquired bacterial pneumonia (CABP).  CABP is the leading cause of infectious death in the United States.

In the LEAP 1 trial, Nabriva Therapeutics’ first of two pivotal Phase 3 clinical trials of lefamulin in patients with CABP, lefamulin met the U.S. Food and Drug Administration (FDA) primary endpoint of non-inferiority (NI, 12.5% margin) compared to moxifloxacin with or without adjunctive linezolid for early clinical response (ECR) assessed 72 to 120 hours following initiation of therapy in the intent to treat (ITT) patient population. In the trial, ECR rates were 87.3% for lefamulin and 90.2% for moxifloxacin with or without linezolid (treatment difference -2.9 [95% confidence interval (CI) -8.5, 2.8]).

“These Phase 3 data provide strong evidence of the potential of lefamulin to treat adults with CABP and provide an alternative to a current gold standard treatment regimen,” said Dr. Colin Broom, chief executive officer of Nabriva Therapeutics. “Due to lefamulin’s flexible dosing and targeted spectrum of activity against the pathogens most commonly associated with CABP, including multidrug-resistant strains, we believe that lefamulin is well suited to be a first-line empiric monotherapy. I am extremely proud and appreciative of the Nabriva Therapeutics team that has advanced lefamulin, which has the potential to be the first in a new class of antibiotics for CABP in more than 15 years, from initial discovery in our labs to this important milestone. We continue to execute on our second pivotal trial evaluating oral lefamulin for the treatment of CABP, with enrollment expected to complete in the fourth quarter of 2017 and topline results anticipated in the spring of 2018.”

Lefamulin also met the primary endpoints for the European Medicines Agency (EMA) of non-inferiority (NI, 10% margin) compared to moxifloxacin with or without adjunctive linezolid in the modified intent to treat (mITT) and clinically evaluable at test of cure (CE-TOC) populations based on an investigator assessment of clinical response (IACR) at a test of cure visit (5 to 10 days following the completion of study therapy).  IACR rates for the mITT population were 81.7% for lefamulin and 84.2% for moxifloxacin with or without linezolid (treatment difference -2.6 [95% CI -8.9, 3.9]) and for the CE-TOC population were 86.9% for lefamulin and 89.4% for moxifloxacin with or without linezolid (treatment difference -2.5 [95% CI -8.4, 3.4]).  IACR is also a key secondary endpoint for the FDA.

“Community-acquired bacterial pneumonia is a common and potentially life-threatening illness for which presently available recommended antimicrobials have potential limitations often associated with resistance or safety,” said Dr. Thomas M. File Jr., M.D., MS, chair of the Infectious Disease Section, Northeast Ohio Medical University, and chair of the Infectious Disease Division, Summa Health. “With bacterial resistance continuing to increase, patients and physicians are in need of new safe and effective treatment options that adhere to the principles of antibiotic stewardship. These positive topline results evaluating the efficacy and safety of lefamulin in patients with community-acquired bacterial pneumonia are promising.”

In addition, in LEAP 1, ECR by pathogen was similar to the overall response rates and was comparable between treatment arms.  Detailed results on a pathogen-by-pathogen basis in the microbiological intent to treat (microITT) population are included in Appendix A to this release.

LEAP 1 enrolled 551 patients: 276 in the lefamulin arm and 275 in the moxifloxacin with or without linezolid arm.  Patients who were aged 65 or older represented 47.8% of the patients in the lefamulin arm compared to 39.3% of the patients in the moxifloxacin with or without linezolid arm.  The lefamulin arm enrolled 196 (71.0%), 76 (27.5%) and 4 (1.4%) patients with a Pneumonia Outcomes Research Team (PORT) class of 3, 4 and 5, respectively.  The moxifloxacin with or without linezolid arm enrolled 1 (0.4%), 201 (73.1%), 70 (25.5%) and 3 (1.1%) patients with a PORT class of 2, 3, 4 and 5, respectively.

In the LEAP 1 trial, a similar rate of treatment-emergent adverse events (TEAEs) was observed in the lefamulin arm (38.1%) and the moxifloxacin with or without linezolid arm (37.7%).  In addition, the rates of TEAEs leading to study drug discontinuation were 2.9% for lefamulin versus 4.4% for moxifloxacin with or without linezolid, and the rates of withdrawal from the trial were 1.8% for lefamulin versus 4.0% for moxifloxacin with or without linezolid.  Death occurred with similar frequency in both arms, with 6 patients dying in the lefamulin arm (2.2%) and 5 patients dying in the moxifloxacin with or without linezolid arm (1.8%).

Adverse events reported in greater than 2.0% of patients receiving study drug (lefamulin versus moxifloxacin with or without linezolid, respectively) were hypokalemia (2.9% versus 2.2%), nausea (2.9% versus 2.2%), insomnia (2.9% versus 1.8%), infusion site pain (2.9% versus 0%), infusion site phlebitis (2.2% versus 1.1%), alanine aminotransaminase (ALT) increase (1.8% versus 2.2%) and hypertension (0.7% versus 2.2%).

Of note, while no documented cases of Clostridium difficile infection were reported in either treatment group, diarrhea was observed in 0.7% and 7.7% of subjects receiving lefamulin and moxifloxacin with or without linezolid, respectively, with a lower overall rate of gastrointestinal TEAEs in the lefamulin arm compared to the moxifloxacin with or without linezolid arm (6.6% versus 13.0%). In addition, no meaningful differences between the lefamulin and moxifloxacin with or without linezolid arms were observed in cardiac (2.9% versus 4.0%) or hepatobiliary (0.7% versus 1.5%) TEAEs.

Elevations in liver transaminases (>3 times the upper limit of normal (ULN)) were comparable in both treatment groups: ALT (7.1% versus 6.4%) and aspartate aminotransferase (AST) (4.1% versus 2.6%) in the lefamulin and moxifloxacin with or without linezolid treatment groups, respectively.  Elevations in liver transaminases (>5 times the upper limit of normal (ULN)) occurred in both treatment groups: ALT (2.2% versus 1.9%) and aspartate aminotransferase (AST) (0.7% versus 0.7%) in the lefamulin and moxifloxacin with or without linezolid treatment groups, respectively.  No patient in either treatment group met Hy’s Law criteria, which is an indicator for severe liver damage.

Changes in QT interval, a measure of the heart’s electrical cycle, that were of potential clinical concern were uncommon.  At steady state, maximum increases in QT interval between 30 to 60 msec occurred in 12 (4.6%) and 14 (5.4%) of patients receiving lefamulin and moxifloxacin with or without linezolid, respectively.  In addition, compared to no patients in the lefamulin arm, one patient in the moxifloxacin arm had an increase in QT interval greater than 60 msec, and one patient in each treatment arm had an increase in absolute QT interval to greater than 500 msec.

Further analysis of the LEAP 1 trial results including analysis of additional patient population groups in the trial and secondary and exploratory endpoints related to these populations groups is ongoing and additional results will be presented at upcoming scientific congresses.

About LEAP 1 Trial Design

LEAP 1 was a multi-center, randomized, controlled, double-blind, global study comparing lefamulin to moxifloxacin, a fluoroquinolone antibiotic, with or without linezolid. The trial was designed to evaluate the efficacy and safety of lefamulin (IV/oral) compared to moxifloxacin (IV/oral), with or without linezolid, in 551 adults with moderate to severe CABP.  Linezolid (or matching placebo for the lefamulin arm) could be added to treatment if an investigator suspected that a patient was infected with methicillin-resistant S. aureus (MRSA) prior to randomization, as moxifloxacin is not approved to treat MRSA.  Lefamulin was dosed at 150 mg IV every 12 hours. The comparator drugs were dosed according to their approved labeling, with moxifloxacin dosed at 400 mg IV daily and linezolid at 600 mg IV every 12 hours. Based on pre-defined criteria, investigators had the option to switch patients to oral therapy after three days (at least six doses) of IV study medication. Study drugs were administered orally as one lefamulin 600 mg tablet every 12 hours, moxifloxacin at 400 mg daily and linezolid at 600 mg every 12 hours.  All patients enrolled in this trial had a PORT class severity of at least 3 on a scale of 1 to 5 (other than one patient in the moxifloxacin with or without linezolid treatment group), which corresponds to moderate to severe clinical disease. Randomization was 1:1 and was stratified by PORT risk class, geography and exposure to prior antibiotics. Patients who received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization were excluded from participating.

For LEAP 1, the primary efficacy endpoint for the FDA was the proportion of patients in the ITT population in each treatment group achieving ECR.  ECR is achieved for patients who were alive, had improvement in at least two of the four cardinal symptoms of CABP as outlined in the current FDA guidance, had no worsening in any of the four cardinal symptoms of CABP and had not received a concomitant antibiotic (other than linezolid) for the treatment of CABP up through 120 hours after the first dose of study drug. The four cardinal symptoms of CABP, as outlined in the current FDA guidance, are difficulty breathing, cough, production of purulent sputum and chest pain. A number of population groups were evaluated in LEAP 1, including an ITT population consisting of all randomized patients regardless of whether they received study medication; a modified intent to treat (mITT) population consisting of all randomized subjects who received any amount of study drug; and a microITT population consisting of all subjects in the ITT population who had at least one baseline bacterial pathogen known to cause CABP, Legionella pneumophila from an appropriate microbiological specimen, or CABP caused by Mycoplasma pneumoniae or Chlamydophila pneumoniae.

Additional Phase 3 Clinical Trial Ongoing

Nabriva Therapeutics’ second pivotal Phase 3 clinical trial, LEAP 2, is a multi-center, randomized, controlled, double-blind, global study comparing oral lefamulin to moxifloxacin. LEAP 2 is designed to evaluate the efficacy and safety of oral lefamulin compared to oral moxifloxacin in patients with moderate CABP. All patients enrolled in LEAP 2 have a PORT class severity of 2 to 4 on a scale of 1 to 5, which corresponds to moderate disease. Nabriva is targeting the enrollment of approximately 738 patients in LEAP

2. The company expects to complete enrollment in the fourth quarter of 2017, and to have topline data available in the spring of 2018.

Conference Call and Webcast

The company will host a conference call and webcast at 8:30 a.m. EDT today. The live webcast can be accessed under “Events and Presentations” in the Investor Relations section of Nabriva Therapeutics’ website at www.nabriva.com and will be accessible for 90 days. The conference call can also be accessed by dialing 1-866-411-8292 (U.S./Canada) or 1-704-908-0383 (international) and providing the passcode 86032729.

About CABP

Based on Nabriva Therapeutics’ combined analysis of the U.S. Centers for Disease Control and Prevention’s 2007 National Ambulatory Medical Care Survey, the National Hospital Ambulatory Medical Care Survey and 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that more than 5 million adults are treated annually for CABP in the United States. Additionally, based on 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that approximately 3.1 million of these adult CABP patients sought treatment in a hospital setting, where most are then treated with in-patient IV and oral antibiotics or out-patient oral antibiotics prescribed for use following hospital discharge or release.

About Nabriva Therapeutics plc

Nabriva Therapeutics is a biopharmaceutical company engaged in the research and development of new medicines to treat serious bacterial 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. Nabriva Therapeutics’ lead product candidate, 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. Nabriva has announced positive topline data for lefamulin from the first of its two global, registrational Phase 3 clinical trials evaluating lefamulin in patients with moderate to severe community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics 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, with the results of the LEAP 1 trial showing a rate of TEAEs comparable to moxifloxacin with or without linezolid. Nabriva Therapeutics intends to further pursue development of lefamulin for additional indications, including the treatment of acute bacterial skin and skin structure infections (ABSSSI), and is developing a formulation of lefamulin appropriate for pediatric use.

Nabriva Therapeutics owns exclusive, worldwide rights to lefamulin, which is protected by composition of matter patents issued in the United States, Europe and Japan.

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 Nabriva’s ongoing Phase 3 clinical trial 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, whether results of Nabriva’s first Phase 3 clinical trial of lefamulin will be indicative of the results for its second Phase 3 clinical trial of lefamulin, 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 and quarterly reports on file 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.

Contact:

INVESTORS

Dave Garrett

Nabriva Therapeutics plc

david.garrett@nabriva.com

610-816-6657

MEDIA

Katie Engleman

Pure Communications

katie@purecommunications.com

910-509-3977

Appendix A

Microbiological ITT	Lefamulin			Moxifloxacin (with or without linezolid)
(microITT)	N = 160 (58.0%)			N = 159 (57.8%)
Baseline Pathogen	N	ECR (%)		N	ECR (%)
Gram Positive
S. pneumoniae (SP)	82/93	88.2	%	91/97	93.8	%
Penicillin-Susceptible SP (PSSP)	17/21	81.0	%	16/18	88.9	%
Penicillin-Intermediate SP (PISP)	5/5	100	%	2/2	100	%
Penicillin-Resistant SP (PRSP)	2/2	100	%	2/3	66.7	%
Multidrug-Resistant SP (MDRSP)	6/6	100	%	5/6	83.3	%
Macrolide-Resistant SP (MRSP)	6/6	100	%	5/6	83.3	%
S. aureus	31/32	96.9	%	13/13	100	%
Gram Negative
H. influenzae	8/8	100	%	6/7	85.7	%
M. catarrhalis	47/52	90.4	%	52/55	94.5	%
Atypicals
M. pneumoniae	16/19	84.2	%	18/20	90.0	%
L. pneumophila	16/18	88.9	%	12/14	85.7	%
C. pneumoniae	10/11	90.9	%	18/19	94.7	%