Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage
company focused on the development and commercialization of novel
antibiotics to treat serious bacterial infections, today announced
changes to its board of directors and executive management team.
David Gill, a current Melinta board member, has
been named chairman of the board of directors, effective
immediately, succeeding Kevin Ferro, who voluntarily resigned from
the position and the board of directors.
John H. Johnson voluntarily resigned from his
position as chief executive officer (CEO) due to changes in the
Company’s circumstances and in order to pursue other opportunities.
Mr. Johnson will serve as acting CEO for at least 30 days to work
through the transition, including the search process and
appointment of a permanent successor. Mr. Johnson also resigned
from his position as director, effective immediately. Additionally,
and at the request of the board of directors, Mr. Johnson will
remain a strategic advisor to Melinta for at least six months.
“On behalf of the Board, I would like to thank
Kevin for his contributions to the Company,” said David Gill,
chairman of Melinta. “The Board and I also want to thank John for
his dedication and service as a long-standing board member and most
recently for his leadership and stepping into the CEO position
during a very challenging time for the Company and antibiotics
industry as a whole. John made many significant contributions to
further advance the Company’s mission to provide life-saving
therapeutic solutions that address the evolving global threat of
bacterial infections and antibiotic resistance. We look forward to
continuing to work closely with John on the process to select a
successor and as a strategic advisor during Melinta’s next phase,”
Gill added.
“It has been an honor to work with such a
talented team that is truly dedicated to providing critical and
potentially life-saving antibiotics to patients in need. Since
joining Melinta as CEO, the organization has made tremendous
strides towards enhancing operational efficiencies, increasing
product sales, working with stakeholders to improve the
reimbursement landscape, securing a Prescription Drug User Fee Act
(PDUFA) action date of October 24, 2019 for the supplemental
new drug application (sNDA) to expand the current indication for
Baxdela® (delafloxacin) for community-acquired bacterial pneumonia
(CABP), and enrolling more than half of the target study population
in a clinical study evaluating a shorter infusion time formulation
of Orbactiv® (oritavancin) for the treatment of adult patients with
acute bacterial skin and skin structure infections (ABSSSI),” said
John H. Johnson, chief executive officer of Melinta. “I look
forward to working with the board and management team to continue
executing against Melinta’s strategy to deliver antibiotics
solutions to both patients and providers,” Johnson added.
Mr. Gill joined the Company’s board of directors
in April 2012. Mr. Gill served as chief financial officer of
EndoChoice Holdings, Inc., a publicly-traded medical device company
from August 2014 to November 2016, and as president and chief
financial officer from March 2016 to November 2016, when the
company was acquired. He served as the chief financial officer of
INC Research Holdings Inc. (now known as Syneos), a clinical
research organization, from February 2011 to August 2013, after
having served as a board member and its audit committee chairman
from 2007 to 2010. Mr. Gill currently serves as a director of
Evolus, Inc., an aesthetics company, YmAbs Therapeutics, an
immuno-oncology company and Strata Skins Sciences, a dermatology
company. Earlier in his career, Mr. Gill served in a variety of
senior executive leadership roles for several medical device
companies, including TramsEnterix, NxStage Medical, CTI Molecular
Imaging, Inc., Novoste Corporation and Dornier Medical. Mr. Gill
holds a B.S. degree, cum laude, in Accounting from Wake Forest
University and an M.B.A. degree, with honors, from Emory
University, and was formerly a certified public accountant.
About Melinta
TherapeuticsMelinta Therapeutics, Inc. is the largest
pure-play antibiotics company, dedicated to saving lives threatened
by the global public health crisis of bacterial infections through
the development and commercialization of novel antibiotics that
provide new therapeutic solutions. Its four marketed products
include Baxdela® (delafloxacin), Vabomere® (meropenem and
vaborbactam), Orbactiv® (oritavancin), and Minocin® (minocycline)
for Injection. This portfolio provides Melinta with the unique
ability to provide providers and patients with a range of solutions
that can meet the tremendous need for novel antibiotics treating
serious infections. Visit www.melinta.com for more information.
Cautionary Note Regarding
Forward-Looking Statements
Certain statements in this communication
constitute “forward-looking statements” within the meaning of
Section 27A of the Securities Act and Section 21E of the Securities
Exchange Act and are usually identified by the use of words such as
“anticipates,” “believes,” “estimates,” “expects,” “intends,”
“may,” “plans,” “projects,” “seeks,” “should,” “will,” and
variations of such words or similar expressions, including
statements related to guidance. We intend these forward-looking
statements to be covered by the safe harbor provisions for
forward-looking statements contained in Section 27A of the
Securities Act and Section 21E of the Securities Exchange Act and
are making this statement for purposes of complying with those safe
harbor provisions. These forward-looking statements reflect our
current views about our plans, intentions, expectations, strategies
and prospects, which are based on the information currently
available to us and on assumptions we have made and include
statements regarding: expectations with respect to our financial
position, results and performance, compliance with our debt
facilities and discussions with our creditors. Although we believe
that our plans, intentions, expectations, strategies and prospects
as reflected in or suggested by those forward-looking statements
are reasonable, we can give no assurance that the plans,
intentions, expectations, strategies or prospects will be attained
or achieved. Furthermore, actual results may differ materially from
those described in the forward-looking statements and will be
affected by a variety of risks and factors that are beyond our
control.
Risks and uncertainties for Melinta include, but
are not limited to, the fact that we have incurred significant
operating losses since inception and will incur continued losses
for the foreseeable future; our limited operating history; our need
for future capital and risks related to our ability to obtain
additional capital to fund future operations; risks related to our
failure to close on the full amount of the two disbursements under
the Vatera loan financing and risks related to the satisfaction of
the closing conditions for the remaining disbursement amount,
including the inability to close on such disbursement; risks
related to our ability to borrow additional amounts under the
Deerfield facility agreement; risks related to compliance with the
covenants under our facilities with Vatera and Deerfield;
risks related to our future liquidity, including uncertainties of
cash flows and inability to meet working capital needs as well as
other milestones, royalty and payment obligations, including as a
result of the outcome of the pending litigation with respect to,
and any requirement to make, payments potentially due under our
purchase agreement with to The Medicines Company; risks that
may arise from the Vatera loan financing and
the Deerfield facility agreement, including potential
dilution to our stockholders and the fact that Vatera beneficially
owns a substantial portion of our common stock; risks related to
our ability to continue as a going concern unless we can secure
additional sources of liquidity; our substantial indebtedness;
risks related to potential strategic transactions; risks related to
the commercial launches of our products and our inexperience as a
company in marketing drug products; the degree of market acceptance
of our products among physicians, patients, health care payors and
the medical community; the pricing we are able to achieve for our
products; failure to obtain and sustain an adequate level of
reimbursement for our products by third-party payors; inaccuracies
in our estimates of the market for and commercialization potential
of our products; failure to maintain optimal inventory levels to
meet commercial demand for any of our products; risks that our
competitors are able to develop and market products that are
preferred over our products; our dependence upon third parties for
the manufacture and supply of our marketed products; failure to
achieve the benefits of our recently completed transactions
with Cempra and The Medicines Company; failure to establish
and maintain development and commercialization collaborations;
uncertainty in the outcome or timing of clinical trials and/or
receipt of regulatory approvals for our product candidates;
undesirable side effects of our products; failure of third parties
to conduct clinical trials in accordance with their contractual
obligations; our ability to identify, develop, acquire or
in-license products; difficulties in managing the growth of our
company; the effects of recent comprehensive tax reform; risks
related to failure to comply with extensive laws and regulations;
product liability risks related to our products; failure to retain
key personnel; inability to obtain, maintain and enforce patents
and other intellectual property rights or the unexpected costs
associated with such enforcement or litigation; risks relating to
third party infringement of intellectual property rights; our
ability to maintain effective internal control over financial
reporting; unfavorable outcomes in any of the class action and
shareholder derivative lawsuits currently pending against the
Company; and the fact that a substantial number of shares of common
stock may be sold into the public markets by one or more of our
large stockholders in the near future. Many of these factors that
will determine actual results are beyond Melinta’s ability to
control or predict.
Other risks and uncertainties are more fully
described in our Annual Report on Form 10-K for the year
ended December 31, 2018, our Revised Definitive Proxy
Statement filed January 29, 2019, and in other filings that
Melinta makes and will make with the SEC. Existing and
prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. The statements made in this press release speak only as of
the date stated herein, and subsequent events and developments may
cause our expectations and beliefs to change. While we may elect to
update these forward-looking statements publicly at some point in
the future, we specifically disclaim any obligation to do so,
whether as a result of new information, future events or otherwise,
except as required by law. These forward-looking statements should
not be relied upon as representing our views as of any date after
the date stated herein.
For More Information:
Media Inquiries:Lindsay RoccoElixir Health
Public Relations+1 862-596-1304lrocco@elixirhealthpr.com
Investor Inquiries:Susan Blum(312)
767-0296ir@melinta.com
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