Nabriva Therapeutics plc (NASDAQ: NBRV) today announced that, after
an assessment of strategic options, its Board of Directors approved
a plan to preserve cash in order to adequately fund an orderly wind
down of the Company’s operations.
As previously disclosed, the Company engaged Torreya Capital to
facilitate the exploration of a range of strategic options,
including potential in-licensing or out-licensing of commercial
stage assets. While the Company continues to work with Torreya
Capital on identifying and evaluating potential strategic options
with the goal of maximizing shareholder value, the Company is
currently focused on the sale of its existing assets, including
Lefamulin and IV Fosfomycin.
To preserve cash in order to adequately fund an orderly wind
down and enable a sale of its assets, Nabriva plans to terminate
all employees, including officers of the Company, not deemed
necessary to execute an orderly wind-down of the Company. Nabriva
estimates that it will incur approximately $6.0 million for
severance and other employee termination-related costs in the first
quarter of 2023. The Company also has terminated its agreement with
Amplity Health, the contract sales organization responsible for
promoting SIVEXTRO and XENLETA, to preserve cash, but will continue
to make both products commercially available. The Company expects
to transition responsibility for the promotion and distribution of
SIVEXTRO back to Merck & Co. Inc. and terminate that agreement
over the coming months. In addition, on January 5, 2023, the
Company repaid $4.5 million to Hercules Capital, including
principal, accrued and unpaid interest, fees and other expenses,
under its loan agreement. Effective at the time of repayment, the
Hercules loan agreement was terminated, and Hercules released all
security interests held on the assets of the Company and its
subsidiaries.
Nabriva’s Board of Directors continues to evaluate alternatives
to maximize shareholder value. In the event that the Board of
Directors determines that a liquidation and dissolution of the
Company pursuant to a Plan of Dissolution to be approved by
shareholders is the best method to maximize shareholder value, the
Company would file proxy materials with the Securities and Exchange
Commission and schedule an extraordinary meeting of its
shareholders to seek approval of such a Plan of Dissolution as
required.
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 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. 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.
About SIVEXTRO
SIVEXTRO (tedizolid phosphate) was approved by the U.S. Food and
Drug Administration in 2014. It is indicated in adults and
pediatric patients 12 years of age and older for the treatment of
acute bacterial skin and skin structure infections (ABSSSI) caused
by susceptible isolates of the following Gram-positive
microorganisms: Staphylococcus aureus (including
methicillin-resistant (MRSA) and methicillin-susceptible (MSSA)
isolates), Streptococcus pyogenes, Streptococcus agalactiae,
Streptococcus anginosus group (including Streptococcus anginosus,
Streptococcus intermedius and Streptococcus constellatus), and
Enterococcus faecalis. To reduce the development of drug-resistant
bacteria and maintain the effectiveness of SIVEXTRO and other
antibacterial drugs, SIVEXTRO should be used only to treat ABSSSI
that are proven or strongly suspected to be caused by susceptible
bacteria. When culture and susceptibility information are
available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local
epidemiology and susceptibility patterns may contribute to the
empiric selection of therapy.
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.
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 identify, assess and
execute a strategic transaction, its ability to preserve cash in
order to adequately fund an orderly wind down of the Company’s
operations, the ability of shareholders and other stakeholders to
realize any value or recovery as part of a wind down process, the
Company’s workforce reduction and future charges expected to be
incurred in connection therewith, 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: Nabriva Therapeutics’ ability to
continue to pay its obligations in the ordinary course of business
as they come due; successfully execute 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.
CONTACT:
For Investors and MediaKim AndersonNabriva
Therapeutics plcir@nabriva.com
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