Press Release

Melinta Therapeutics to Present Detailed Results from Vabomere TANGO II Trial as well as New In Vitro and In Vivo Findings from Baxdela and Pyrrolocytosine Candidate at ECCMID 2018

April 16, 2018

NEW HAVEN, Conn., April 16, 2018 (GLOBE NEWSWIRE) -- Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, today announced that a total of 12 presentations are planned at the upcoming European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting April 21-24, 2018 in Madrid, Spain. Detailed results from the Phase 3 TANGO II study of Vabomere™ (meropenem and vaborbactam) in patients with known or suspected carbapenem-resistant Enterobacteriaceae (CRE) will be presented in a series of six oral and poster presentations.

TANGO II was a randomized, open-label Phase 3 trial that enrolled patients with complicated urinary tract infection, acute pyelonephritis, hospital-acquired/ventilator-associated bacterial pneumonia, bacteremia or complicated intra-abdominal infection due to known or suspected CRE. Vabomere was approved by the U.S. Food and Drug Administration in 2017 for the treatment of adult patients with complicated urinary tract infections, including pyelonephritis, caused by designated susceptible Enterobacteriaceae.

Melinta’s TANGO II presentations are as following:

  • Oral Session (OS009) - Predicting carbapenem resistance among Gram-negative pathogens in complicated urinary tract infections. 4/21/20188:57 - 9:07am
  • Paper Poster (PS018) - Meropenem-vaborbactam versus best-available therapy for carbapenem-resistant Enterobacteriaceae infections in TANGO II: outcomes in patients with cancer. 4/21/20183:30 - 4:30pm
  • Mini-oral Flash Session (OF081) - Meropenem-vaborbactam versus best available therapy for carbapenem-resistant Enterobacteriaceae infections in TANGO II: outcomes in all treated patients regardless of pathogen. 4/22/201811:42 - 11:45am
  • ePoster Mini Oral Session (OE112) - Meropenem-vaborbactam versus best available therapy for infections due to carbapenem-resistant Enterobacteriaceae in TANGO II: impact of prior antibiotic failure on clinical outcomes. 4/22/2018 4:48 – 4:53pm
  • Paper Poster Session (PS055) - Activity of Meropenem-Vaborbactam against Enterobacteriaceae Isolates Collected During 2016. 4/22/2018 13:30 – 14:30
  • Paper Poster Session (PS111) - Ex vivo characterization of effects of renal replacement therapy modalities and settings on pharmacokinetics of meropenem-vaborbactam. 4/24/201812:30 - 1:30pm

Analyses of demographic and pathogen distribution in patients presenting with acute bacterial skin and skin structure infections (ABSSSIs) as well as in vitro efficacy findings for Baxdela™ (delafloxacin) will also be discussed during poster sessions during ECCMID, as follows:

  • ePoster mini-oral Session (EV016) - Demographics of culture positive patients in the admission period with skin and skin structure infection in the US: a multicenter evaluation of pathogen distribution. 4/21/20188:00am - 6:00pm
  • Paper Poster Session (PS034) - In vitro evaluation of delafloxacin activity when tested against contemporary European community-acquired bacterial respiratory tract infection isolates (2014-2017): Results from the SENTRY Antimicrobial Surveillance Program. 4/22/201812:30 - 1:30pm
  • Paper Poster Session (PS105) - A multicentre evaluation of pathogen distribution in culture-positive patients admitted with skin and skin-structure infection in the US. 4/24/201812:30 - 1:30pm

An update on the company’s ESKAPE Pathogen Program will be provided in three oral and poster presentations. These presentations, which highlight the in vitro and in vivo activity of a novel pyrrolocytosine lead investigational compound are scheduled as follows:

  • Paper Poster Session (PS006) - Progress in the ESKAPE Pathogen Program: the in vitro profile of an advanced lead, RX-P2382. 4/21/20183:30 - 4:30pm
  • Paper Poster Session (PS009) - Progress in the ESKAPE Pathogen Program: the exploratory in vivo toxicological profile of an advanced lead, RX-P2382. 4/21/20183:30 - 4:30pm
  • Oral Session (OS046) - Progress in the ESKAPE Pathogen Program: the in vivo profile of an advanced lead, RX-P2382. 4/21/20184:54 - 5:04pm

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 marketed products include Baxdela™ (delafloxacin), Vabomere™ (meropenem and vaborbactam), Orbactiv® (oritavancin) and Minocin® (minocycline) for Injection. It also has an extensive pipeline of preclinical and clinical-stage products representing many important classes of antibiotics, each targeted at a different segment of the anti-infective market. Together, 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. 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. 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 or strategies 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; uncertainties of cash flows and inability to meet working capital needs as well as other milestone, royalty and payment obligations; the fact that our independent registered public accounting firm’s report on the Company’s 2016 and 2017 financial statements contains an explanatory paragraph that states that the 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 our 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 amount of shares of common stock may be sold into the public markets by one or more of our large shareholders 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, 2017, 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:
David Belian
(203) 848-6276

Investor Inquiries:
Lisa DeFrancesco
(847) 681-3217

Raj Mistry
(312) 801-2051

 

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Source: Melinta Therapeutics