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- Expects top-line data from LEAP 1 CABP Phase 3 trial in third quarter 2017 and from LEAP 2 CABP Phase 3 trial in first quarter 2018

Vienna, Austria / King of Prussia, PA, May 12, 2017 – Nabriva Therapeutics AG (NASDAQ: NBRV), a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, today provided a business and clinical development update and reported its financial results for the three months ended March 31, 2017.

“Nabriva remains on-track for a potentially transformational year with last patient, last visit for the LEAP 1 trial scheduled to occur by the end of May and top-line clinical data for the LEAP 1 trial expected in the third quarter of 2017,” said Dr. Colin Broom, Chief Executive Officer of Nabriva. “Additionally, based on current projections, we continue to expect to complete patient enrollment for LEAP 2 in the fourth quarter of 2017 and anticipate receiving top-line data for LEAP 2 in the first quarter of 2018.”

Recent Corporate and Development Highlights

  • Following completion of lefamulin evaluation against pneumonia (LEAP) 1 patient enrollment in April 2017 and estimation of final data collection and analysis timelines, the company expects to announce LEAP 1 top-line efficacy and safety data in the third quarter of 2017. LEAP 1 is a Phase 3 global, registrational clinical trial evaluating the safety and efficacy of lefamulin (IV/oral) in patients with moderate to severe community-acquired bacterial pneumonia (CABP).
  • At the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) that took place in Vienna, Austria from April 22-25, 2017, Nabriva showcased nine abstracts, three of which were selected as oral presentations. These data are part of a growing body of evidence supporting lefamulin’s profile as a potential first-line, empiric treatment for the key pathogens, including multidrug resistant strains, that are known to cause CABP.
  • On April 17, 2017, Nabriva announced that its supervisory board and management board approved the redomiciliation of the holding company of Nabriva Therapeutics plc (Nabriva plc) and its subsidiaries (Nabriva Group) from Austria to Ireland. The redomicilation will be effected by the exchange of American depositary shares and common shares of Nabriva plc for shares of Nabriva Therapeutics Plc (Nabriva Ireland), a newly-formed Irish public limited company, with Nabriva Ireland becoming the publicly-traded parent entity of Nabriva plc. Once the transaction is completed, the current Austrian publicly-traded parent company, will become a subsidiary of the newly-formed Irish company, and it is expected that Nabriva Ireland will then become the publicly-traded parent company of the Nabriva Group with its tax residency in Ireland.

 

FIRST Quarter 2017 FINANCIAL HIGHLIGHTS

  • For the three months ended March 31, 2017, Nabriva reported a net loss of $15.2 million or $5.60 per share, compared to a net loss of $13.6 million or $6.42 per share for the three months ended March 31, 2016.
  • Research and development expenses decreased by $0.4 million from $13.0 million for the three months ended March 31, 2016 to $12.6 million for the three months ended March 31, 2017. The change was primarily due to higher costs related to the initiation and continuation of patient enrollment for LEAP 1 and LEAP 2 during the three months ended March 31, 2016. Research materials and purchased services for the company’s other programs and initiatives were relatively limited during both periods.
  • General and administrative expense increased by $1.1 million from $3.1 million for the three months ended March 31, 2016 to $4.2 million for the three months ended March 31, 2017. The increase was primarily due to a $0.7 million increase in legal fees related to the redomiciliation of the company’s ultimate parent company from Austria to Ireland and a $0.4 million increase in pre-commercialization activities and increased professional service fees.
  • As of March 31, 2017, Nabriva had $68.2 million in cash, cash equivalents and short-term investments compared to $83.9 million as of December 31, 2016.
  • As of April 30, 2017, Nabriva had 2,721,086 common shares outstanding, of which 2,260,443 were represented by 22,604,430 ADSs. Each Nabriva common share is equivalent to 10 ADSs.

Please refer to our Annual Report on Forms 10-K for the fiscal year ended December 31, 2016 and our Quarterly Report on Form 10-Q for the three months ended March 31, 2017, which are filed with the U.S. Securities and Exchange Commission, for additional information regarding our business and financial results and to review our financial statements.

On May 10, 2017, Nabriva Therapeutics plc (the “Company”) filed its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 (the “Form 10-Q”). Immediately after the filing of the Form 10-Q, the Company issued a press release announcing its consolidated financial results for the quarter ended March 31, 2017. The Company is reissusing that press release to reflect the correction of inadvertent discrepancies in the financial information disclosed in the tables at the end of the press release as compared to the financial information that was contained in the Form 10-Q. The discrepancies in the press release required a correction of total “Net cash used in operating activities” in the Consolidated Statement of Cash Flows for the three months ended March 31, 2016 and March 31, 2017 (although the components of this total amount were accurately stated in the press release).

About Nabriva Therapeutics AG
Nabriva Therapeutics is a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infectives to treat serious infections, with a focus on the pleuromutilin class of antibiotics. Nabriva Therapeutics’ medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations of its lead product candidate, lefamulin. Lefamulin is a novel semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class available for systemic administration in humans. The company believes that lefamulin is the first antibiotic with a novel mechanism of action to have reached late-stage clinical development in more than a decade. Lefamulin is currently being evaluated in two global, registrational Phase 3 clinical trials in patients with moderate to severe CABP. Nabriva believes lefamulin is well positioned for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, oral and IV formulations and a favorable tolerability profile. Nabriva Therapeutics intends to further pursue the development of lefamulin for additional indications, including the treatment of acute bacterial skin and skin structure infections (ABSSSI), and are 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.

Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for Nabriva, including but not limited to statements about the development of Nabriva’s product candidates, such as plans for the design, conduct and timelines of Phase 3 clinical trials of lefamulin for CABP, the clinical utility of lefamulin for CABP and Nabriva’s plans for filing of regulatory approvals and efforts to bring lefamulin to market, the development of lefamulin for additional indications, the development of additional formulations of lefamulin, plans to pursue research and development of other product candidates, plans for the redomiciliation of Nabriva’s parent company from Austria to Ireland, including related internal reorganization transactions and plans for the equity securities of any successor company to be publicly traded in the United States, the sufficiency of Nabriva’s existing cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including lefamulin for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption "Risk Factors" in Nabriva’s annual 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:
INVESTOR RELATIONS
Will Sargent
Nabriva Therapeutics plc
  William.Sargent@nabriva.com
610-813-6406

MEDIA
Katie Engleman
Pure Communications, Inc.
Katie@purecommunicationsinc.com
910-509-3977

 

CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (unaudited)

(all amounts in USD)

 

 

 

 

 

Three Months Ended
March 31,

 

(in thousands, except per share data)

 

 

 

 

 

2016

 

2017

 

Revenues:

 

 

 

 

 

 

 

 

 

 

Research premium and grant revenue

 

 

 

 

 

 

 

$

1,419

 

$

1,678

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

 

 

 

 

 

$

(13,036)

 

$

(12,660)

 

General and administrative

 

 

 

 

 

 

(3,085)

 

(4,218)

 

Total operating expenses

 

 

 

 

 

 

 

$

(16,121)

 

$

(16,878)

 

Loss from operations

 

 

 

 

 

 

 

$

(14,702)

 

$

(15,200)

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

Other income (expense), net

 

 

 

 

 

 

998

 

206

 

Interest income

 

 

 

 

 

 

88

 

121

 

Interest expense

 

 

 

 

 

 

-

 

(1)

 

Loss before income taxes

 

 

 

 

 

 

 

$

(13,616)

 

$

(14,874)

 

Income tax benefit (expense)

 

 

 

 

 

 

17

 

(349)

 

Net loss

 

 

 

 

 

 

 

$

(13,599)

 

$

(15,223)

 

Other comprehensive income (loss), net of tax

 

 

 

 

 

 

 

 

 

 

Unrealized gains (losses) on available-for-sale financial assets

 

 

 

 

 

 

41

(16)

 

Reclassification to net income (loss)

 

 

 

 

 

 

 

 

-

 

-

 

Other comprehensive income (loss), net of tax

 

 

 

 

 

 

 

$

41

 

$

(16)

 

Comprehensive loss

 

 

 

 

 

 

 

$

(13,558)

 

$

(15,239)

 

 

 

 

 

 

 

Three Months Ended
March 31,

 

Loss per share

 

 

 

 

 

2016

 

2017

 

Basic ($ per share)

 

 

 

 

 

 

 

$

(6.42)

 

$

(5.60)

 

Diluted ($ per share)

 

 

 

 

 

 

 

$

(6.42)

 

$

(5.60)

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of shares:

 

 

 

 

 

 

 

 

 

 

Basic

 

 

 

 

 

 

2,117,895

 

2,720,423

 

Diluted

 

 

 

 

 

 

2,117,895

 

2,720,423

 


CONSOLIDATED STATEMENT OF CASH FLOWS (unaudited)

(all amounts in USD)

 

 

 

 

 

Three Months Ended
March 31,

 

 

(in thousands)

 

 

 

2016

 

2017

 

 

Cash flows from operating activities

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

$

(13,599)

 

$

(15,223)

 

 

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Non-cash other expense, net

 

 

 

(924)

 

(266)

 

 

Non-cash interest income

 

 

 

(44)

 

(30)

 

 

Non-cash interest expense

 

 

 

-

 

-

 

 

Depreciation and amortisation expense

 

 

 

45

 

76

 

 

Stock-based compensation

 

 

 

580

 

684

 

 

Deferred income taxes

 

 

 

(18)

 

178

 

 

Other, net

 

 

 

1

 

86

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Changes in long-term receivables

 

 

 

(15)

 

(5)

 

 

Changes in other receivables

 

 

 

(1,638)

 

(1,586)

 

 

Changes in accounts payable

 

 

 

2,235

 

1,789

 

 

Changes in accrued expenses and other liabilities

 

 

 

2,491

 

(383)

 

 

Changes in other non-current liabilities

 

 

 

8

 

6

 

 

Changes in income tax liabilities

 

 

 

(1)

 

(10)

 

 

Net cash used in operating activities

 

 

 

(10,879)

 

(14,684)

 

 

Cash flows from investing activities

 

 

 

 

 

 

 

 

Purchases of plant and equipment and intangible assets

 

 

 

(67)

 

(25)

 

 

Purchases of available-for-sale securities

 

 

 

-

 

-

 

 

Purchases of term deposits

 

 

 

-

 

-

 

 

Proceeds from sales of property, plant and equipment

 

 

 

-

 

2

 

 

Proceeds from maturities of term deposits

 

 

 

-

 

-

 

 

Proceeds from sales of available-for-sale securities

 

 

 

3,000

 

10,000

 

 

Net cash provided by investing activities

 

 

 

2,933

 

9,977

 

 

Cash flows from financing activities

 

 

 

 

 

 

 

 

Proceeds from December 2016 financing

 

 

 

-

 

-

 

 

Proceeds from long-term debt

 

 

 

-

 

229

 

 

Proceeds from exercise of stock options

 

 

 

29

 

10

 

 

Equity transaction costs

 

 

 

-

 

(1,410)

 

 

Net cash provided by (used in) financing activities

 

 

 

29

 

(1,171)

 

 

 

 

 

 

 

 

 

 

 

Effects of foreign currency translation on cash and cash equivalents

 

 

 

924

 

266

 

 

Net decrease in cash and cash equivalents

 

 

 

(6,993)

 

(5,612)

 

 

Cash and cash equivalents at beginning of period

 

 

 

36,446

 

32,778

 

 

Cash and cash equivalents at end of period

 

 

 

 

$

29,453

 

$

27,166

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)

 

(all amounts in USD)

 

 

 

 

 

 

 

 

(in thousands)

 

As of
December 31, 2016

 

As of
March 31, 2017

 

 

 

 

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

32,778

 

$

27,166

 

Short-term investments

 

51,106

 

41,061

 

Other receivables

 

5,561

 

7,448

 

Prepaid expenses

 

1,176

 

903

 

Total current assets

 

90,621

 

76,578

 

Property, plant and equipment, net

 

519

 

490

 

Intangible assets, net

 

270

 

224

 

Long-term receivables

 

420

 

424

 

Deferred tax assets

 

1,410

 

1,232

 

Total assets

 

$

93,240

 

$

78,948

 

 

 

 

 

 

 

Liabilities and equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

2,551

 

$

4,337

 

Accrued expense and other current liabilities

 

13,326

 

11,553

 

Total current liabilities

 

15,877

 

15,890

 

Non-current liabilities:

 

 

 

 

 

Long-term debt

 

-

 

203

 

Other non-current liabilities

 

107

 

134

 

Total non-current liabilities

 

107

 

337

 

Total liabilities

 

$

15,984

 

$

16,227

 

Commitments and contingencies

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

Common stock

 

$

2,939

 

$

2,946

 

Treasury shares

 

-

 

-

 

Additional paid in capital

 

279,149

 

279,848

 

Accumulated other comprehensive income (loss)

 

10

 

(7)

 

Accumulated deficit

 

(204,842)

 

(220,066)

 

Total stockholders’ equity

 

 

77,256

 

62,721

 

Total liabilities and stockholders’ equity

 

$

93,240

 

$

78,948