- New Drug Application for CONTEPO™ submitted to FDA in October 2018 -
- Company preparing for potential commercialization of two, first-in-class antibiotics,
Lefamulin (IV and Oral) and CONTEPO (IV) in the United States in 2019 -
DUBLIN, Ireland, Nov. 06, 2018 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, today provided a business and clinical development update and reported its financial results for the quarter ended September 30, 2018.
“Nabriva has continued to make significant progress in potentially bringing two first-in-class antibiotics to patients in need of better treatment options here in the United States,” said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. “We have completed our NDA submission for CONTEPO to treat complicated-urinary tract infections (cUTI), including acute pyelonephritis, and remain on track for our NDA submission for lefamulin for the treatment of community-acquired bacterial pneumonia (CABP) by both intravenous and oral routes in the fourth quarter of 2018. We remain focused on commercializing both lefamulin and CONTEPO in the United States with our own targeted sales, marketing and medical affairs organizations and continue to identify and potentially secure external collaborators to help advance our efforts to develop and commercialize lefamulin outside the United States.”
RECENT CORPORATE AND DEVELOPMENT HIGHLIGHTS
FINANCIAL RESULTS
Three Months Ended September 30, 2018 and 2017
Nine Months Ended September 30, 2018 and 2017
Please refer to the Annual Report on Form 10-K of Nabriva Therapeutics for the fiscal year ended December 31, 2017 and Nabriva Therapeutics’ Quarterly Report on Form 10-Q for the three months ended September 30, 2018, filed with the U.S. Securities and Exchange Commission, for additional information regarding the Company’s business and financial results.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics has two product candidates that are in late stage development: lefamulin, under development to potentially be the first pleuromutilin antibiotic available for I.V. and oral administration in humans, and CONTEPO, a potential first-in-class in the United States I.V. antibiotic for cUTI. Nabriva Therapeutics is developing both I.V. and oral formulations of lefamulin for the treatment of community-acquired bacterial pneumonia (CABP) and CONTEPO I.V. for cUTIs, including acute pyelonephritis. Nabriva Therapeutics may potentially develop lefamulin and CONTEPO for additional indications. For more information, please visit https://www.nabriva.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 the development of Nabriva Therapeutics’ product candidates, such as the future development or commercialization of lefamulin and CONTEPO, conduct and timelines of clinical trials, the clinical utility of lefamulin for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings, efforts to bring lefamulin and CONTEPO to market, the market opportunity for and the potential market acceptance of lefamulin for CABP and CONTEPO for cUTI, the development of lefamulin and CONTEPO for additional indications, the development of additional formulations of lefamulin and CONTEPO, plans to pursue research and development of other product candidates, the sufficiency of Nabriva Therapeutics’ 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 content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, Nabriva Therapeutics’ ability to realize the anticipated benefits, synergies and growth prospects of its acquisition of Zavante Therapeutics, 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, whether results of ZEUS will be indicative of results for any ongoing or future clinical trials and studies of CONTEPO, 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 and CONTEPO for the treatment of cUTI, the ability to retain and hire key personnel, the sufficiency of cash resources and need for additional financing 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
Dave Garrett
Nabriva Therapeutics plc
david.garrett@nabriva.com
610-816-6657
FOR MEDIA
Benjamin Navon
W2O Group
bnavon@w2ogroup.com
617-337-4166
Consolidated Balance Sheets (unaudited) | ||||||||||||||
(in thousands, except share data) | As of December 31, 2017 | As of September 30, 2018 | ||||||||||||
Assets | ||||||||||||||
Current assets: | ||||||||||||||
Cash and cash equivalents | $ | 86,769 | $ | 100,331 | ||||||||||
Short-term investments | 110 | 326 | ||||||||||||
Other receivables | 5,402 | 7,362 | ||||||||||||
Contract asset | — | — | 1,500 | |||||||||||
Prepaid expenses | 1,558 | 1,163 | ||||||||||||
Total current assets | 93,839 | 110,682 | ||||||||||||
Property, plant and equipment, net | 1,327 | 1,226 | ||||||||||||
Intangible assets, net | 172 | 109 | ||||||||||||
Long-term receivables | 425 | 428 | ||||||||||||
Total assets | $ | 95,763 | $ | 112,445 | ||||||||||
Liabilities and equity | ||||||||||||||
Current liabilities: | ||||||||||||||
Accounts payable | $ | 5,136 | $ | 4,765 | ||||||||||
Accrued expense and other current liabilities | 8,124 | 10,300 | ||||||||||||
Total current liabilities | 13,260 | 15,065 | ||||||||||||
Non-current liabilities: | ||||||||||||||
Long-term debt | 232 | 710 | ||||||||||||
Other non-current liabilities | 203 | 244 | ||||||||||||
Total non-current liabilities | 435 | 954 | ||||||||||||
Total liabilities | 13,695 | 16,019 | ||||||||||||
Stockholders’ Equity: | ||||||||||||||
Ordinary shares, nominal value $0.01, 1,000,000,000 ordinary shares authorized at September 30, 2018; 36,707,685 and 66,484,159 issued and outstanding at December 31, 2017 and September 30, 2018, respectively | 367 | 665 | ||||||||||||
Preferred shares, par value $0.01, 100,000,000 shares authorized at September 30, 2018; None issued and outstanding | — | - | — | |||||||||||
Additional paid in capital | 360,872 | 458,887 | ||||||||||||
Accumulated other comprehensive income | 27 | 27 | ||||||||||||
Accumulated deficit | (279,198 | ) | (363,153 | ) | ||||||||||
Total stockholders’ equity | 82,068 | 96,426 | ||||||||||||
Total liabilities and stockholders’ equity | $ | 95,763 | $ | 112,445 |
Consolidated Statements of Operations (unaudited) | |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
(in thousands, except share and per share data) | 2017 | 2018 | 2017 | 2018 | |||||||||||||
Revenues: | |||||||||||||||||
Collaboration revenue | $ | — | $ | — | $ | — | $ | 6,500 | |||||||||
Research premium and grant revenue | 1,468 | 461 | 4,197 | 2,359 | |||||||||||||
Total Revenue: | 1,468 | 461 | 4,197 | 8,859 | |||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | (12,668 | ) | (40,804 | ) | (36,371 | ) | (60,800 | ) | |||||||||
General and administrative | (9,525 | ) | (12,582 | ) | (19,313 | ) | (31,555 | ) | |||||||||
Total operating expenses | (22,193 | ) | (53,386 | ) | (55,684 | ) | (92,355 | ) | |||||||||
Loss from operations | (20,725 | ) | (52,925 | ) | (51,487 | ) | (83,496 | ) | |||||||||
Other income (expense): | |||||||||||||||||
Other income (expense), net | 301 | (54 | ) | 391 | (172 | ) | |||||||||||
Interest income | 69 | 11 | 302 | 39 | |||||||||||||
Interest expense | (42 | ) | (8 | ) | (46 | ) | (19 | ) | |||||||||
Loss before income taxes | (20,397 | ) | (52,976 | ) | (50,840 | ) | (83,648 | ) | |||||||||
Income tax benefit (expense) | (1,872 | ) | 151 | (1,254 | ) | (307 | ) | ||||||||||
Net loss | $ | (22,269 | ) | $ | (52,825 | ) | $ | (52,094 | ) | $ | (83,955 | ) | |||||
Loss per share | |||||||||||||||||
Basic and Diluted | $ | (0.79 | ) | $ | (0.90 | ) | $ | (1.89 | ) | $ | (1.85 | ) | |||||
Weighted average number of shares: | |||||||||||||||||
Basic and Diluted | 28,147,226 | 58,442,987 | 27,517,267 | 45,369,040 |
Condensed Consolidated Statements of Cash Flows (unaudited) | ||||||
Nine Months Ended September 30, | ||||||||||||
(in thousands) | 2017 | 2018 | ||||||||||
Net cash provided by (used in): | ||||||||||||
Operating Activities | $ | (45,266 | ) | $ | (50,492 | ) | ||||||
Investing Activities | 49,361 | (4,375 | ) | |||||||||
Financing Activities | 73,929 | 68,596 | ||||||||||
Effects of foreign currency translation on cash and cash equivalents | 1,356 | (167 | ) | |||||||||
Net increase in cash and cash equivalents | 79,380 | 13,562 | ||||||||||
Cash and cash equivalents at beginning of period | 32,778 | 86,769 | ||||||||||
Cash and cash equivalents at end of period | $ | 112,158 | $ | 100,331 | ||||||||