Melinta Therapeutics to Present at Making a Difference in Infectious Diseases (MAD-ID) 2019 Annual Meeting
May 07 2019 - 7:30AM
Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage
company focused on the development and commercialization of novel
antibiotics to treat serious bacterial infections, announced today
that it will present data on its portfolio, including results from
its real-world registry studies of VABOMERE® (meropenem and
vaborbactam), ORBACTIV® (oritavancin), and MINOCIN® (minocycline)
for Injection at the upcoming Making a Difference in Infectious
Diseases (MAD-ID) 2019 Annual Meeting held from May 8-11 2019 in
Orlando, Florida.
"Our presentations demonstrate Melinta’s
continued commitment to combatting antimicrobial resistance by
helping to inform clinical decision-making for the responsible and
sustainable use of our antibiotics,” said Sue Cammarata, M.D.,
chief medical officer of Melinta.
Real-World Registry
Studies:
- Meropenem/Vaborbactam versus Ceftazidime/Avibactam for
Treatment of Carbapenem-resistant Enterobacteriaceae Infections, R.
Ackley et al. (Poster: 39 OR FRS)
- Meropenem/Vaborbactam in Patients with Carbapenem-resistant
Enterobacteriaceae Gram-negative Blood Stream Infection: A Case
Series, S. Alosaimy et al. (Poster: 121 OR FRS)
- Real-World Efficacy and Safety of Oritavancin Multiple Dose
Treatment in Patients with Complicated Gram-Positive Infections, M.
Sierra-Hoffman et al. (Poster: 25 OR)
- Minocycline IV is Effective and Well-tolerated in the Treatment
of Pneumonia and Bacteremia Due to Stenotrophomonas maltophilia, M.
Sierra-Hoffman et al. (Poster: 26 OR)
Additional Poster
Presentations:
BAXDELA® (delafloxacin)
- Use of the Combination Antibiogram in the Era of MDR
Gram-negative Pathogens, K. Klinker (Poster: 29 E)
- Pathogen Type and Inappropriate Empiric Therapy (IET) in
Culture-Positive Skin and Soft Tissue Infection (SSS) among
Hospitalized Patients in the U.S., 2015-2017, S. Cammarata et al.
(Poster: 24 E)
- Outcomes in Patients with History of Cardiac or Vascular
Disease (CV) During Treatment of Acute Bacterial Skin and Skin
Structure Infection (ABSSSI) with Delafloxacin (DLX) vs
Vancomycin/Aztreonam (VAN/AZ), G. Oguchi Et Al. (Poster: 27 E)
- Resolution of Signs and Symptoms (S&S) of Acute Bacterial
Skin and Skin Structure Infections (ABSSSI) with Delafloxacin (DLX)
IV/oral therapy, J. Pullman et al. (Poster: 30 E)
- Evaluation of Delafloxacin Activity and Treatment Outcome for
Phase 3 Acute Bacterial Skin and Skin Structure Infection Clinical
Trial Anaerobic Isolates, D. Shortridge et al. (Poster: 38 E)
VABOMERE® (meropenem and
vaborbactam)
- Epidemiology and Outcomes of Carbapenem Resistance Among
Patients with Hospital-Acquired and Ventilator-Associated
Pneumonia, M. Zilberberg et al. (Poster: 23 E)
- Predicting Carbapenem Resistance Among Gram-Negative Pathogens
in Complicated Urinary Tract Infections, M. Zilberberg Et Al.
(Poster: 37E)
ORBACTIV® (oritavancin)
- Comparisons of 30-Day Admission and 30-Day Total Healthcare
Costs Between Patients Who Were Treated With Oritavancin (ORI) or
Vancomycin (VAN) for a Skin Infection in the Outpatient Setting, T.
Lodise et al. (Poster: 28 E)
About Melinta Therapeutics
Melinta 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 U.S. 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 StatementsCertain 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. 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 the
satisfaction of the closing conditions for the remaining two
disbursements under the loan agreement with Vatera, including any
consequences of a failure to close on the two disbursements under
the Vatera loan financing; risks related to compliance with the
covenants under our facilities with Vatera and Deerfield;
uncertainties of cash flows and inability to meet working capital
needs as well as other milestone, 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 The Medicines Company; risks
that may arise from the consummation of the Vatera loan financing
and the effectiveness of the amendment to
the Deerfield facility agreement, including potential
dilution to our stockholders and the fact that Vatera will
beneficially own a substantial portion of our common stock; the
fact that our independent registered public accounting firm’s
report on the Company’s 2016, 2017, and 2018 financial statements
contains an explanatory paragraph that states that our recurring
losses from operations and our need to obtain additional capital
raises substantial doubt about our ability to continue as a going
concern; our substantial indebtedness; 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+1 312-767-0296
ir@melinta.com
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