Press Release

Melinta Therapeutics Demonstrates Breadth of Commercial and Clinical Programs with 20 Presentations at ASM Microbe 2018

May 31, 2018

NEW HAVEN, Conn., May 31, 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 20 presentations are planned at the American Society for Microbiology’s annual ASM Microbe 2018 meeting from June 7-11, 2018 in Atlanta, GA.

Presentations of note include pharmacoeconomic analyses of Vabomere™ (meropenem and vaborbactam) and Orbactiv® (oritavancin), and analyses showing the rising incidence of Gram-negative pathogens in skin and skin structure infections (SSSIs) and the changes to empiric therapy that may be considered to improve outcomes.

In addition, Melinta will have multiple presentations on the potential of its experimental, pre-clinical pyrrolocytocines, including in the treatment of bio-threats such as Yersinia pestis (plague) and Bacillus anthracis (anthrax).

Poster and oral presentations for Melinta’s commercial and clinical-stage programs follow.

Baxdela:

  • Poster 238 - A Multi-Site Study Comparing a Commercially Prepared Dried MIC Susceptibility System to the CLSI/ISO Broth Microdilution Method for FDA Approved Delafloxacin (Baxdela™) using Gram-Negative Non-Fastidious Organisms; June 8 from 11:00 a.m.1:00 p.m.
  • Oral Presentation (Session 313) - Molecular Properties Matter: The Chemical Features and Resultant Biol. Profile of Delafloxacin; June 9 from 3:00 p.m.3:30 p.m.
  • Poster 209 - A Multi-Site Study Comparing a Commercially Prepared Dried MIC Susceptibility System to the CLSI Broth Microdilution Method for FDA Approved Delafloxacin (Baxdela™) using Fastidious Org; June 9 from 11:00 a.m.1:00 p.m.
  • CPHM Late Breaking Poster LB2 - Delafloxacin: Activity against Fastidious Organisms Tested by EUCAST vs CLSI Methodology; June 10 from 12:45 p.m.2:45 p.m.
  • Poster 397 - In vitro Evaluation of Delafloxacin Activity When Tested against Contemporary Multidrug-Resistant Streptococcus pneumonia (2014-2017): Results from the SENTRY Antimicrobial Surveillance Program; June 10 from 12:45 p.m.2:45 p.m.

ABSSSI Treatment Landscape

  • Poster 415 - Microbiology of Culture-positive Skin and Skin Structure Infection Among Hospitalized Patients in the U.S., 2015-2017; June 8 from 11:00 a.m.1:00 p.m.
  • Poster 569 - Pathogen Type and Inappropriate Empiric Therapy (IET) in Culture-positive Skin and Soft Tissue Infection Among Hospitalized Patients in the U.S., 2015-2017; June 9 from 11:00 a.m.1:00 p.m.

Vabomere:

  • Poster 233 - Comparative Evaluation of Meropenem/Vaborbactam Mic Determination with the New Etest® Mev and CLSI 2017 Broth Microdilution Method; June 8 from 11:00 a.m.1:00 p.m.
  • Poster 234 - Development of Meropenem-Vaborbactam MIC Assay for Gram Negative Bacteria on MicroScan Dried Gram-Negative MIC Panels; June 8 from 11:00 a.m.1:00 p.m.
  • Poster 240 - Multi-Site Evaluation of Meropenem/vaborbactam MIC Test Strip Compared to Broth Microdilution for Enterbacteriaceae and P. aeruginosa; June 8 from 11:00 a.m.1:00 p.m.
  • Poster 395 - Epidemiology and Outcomes of Carbanpenem Resistance among Patients with Hospital-Acquired and Ventilator-Associated Pneumonia; June 8 from 11:00 a.m.1:00 p.m.
  • Oral Presentation (Session 205) - Predicting Carbapenem Resistance among Gram-Negative Pathogens in Complicated Urinary Tract Infections; June 9 from 11:40 a.m.11:50 a.m. (Will be presented as poster 705; June 10 from 12:45 p.m.2:45 p.m.)
  • Poster 710 - Budget Impact and Cost-effectiveness of Meropenem-Vaborbactam (M-V) Compared with Ceftazidime-Avibactam (C-A) in U.S. Hospitals; June 10 from 12:45 p.m.2:45 p.m.

Orbactiv:

  • Poster 688 - Admission Rate and Length of Stay for Skin Infection Patients in U.S. Hospitals; Use of Oritavancin is Associated with Lower Rates of Hospital Admission and Shorter Length of Stay; June 8 from 11:00 a.m.1:00 p.m.
  • Poster 689 - Economics of Treatment of Skin and Soft Tissue Infections (SSTI) in U.S. Hospitals; June 8 from 11:00 a.m.1:00 p.m.
  • Poster 452 - Current Assessment of Oritavancin Activity Against Multidrug-Resistant Enterococcal Clinical Isolates; June 8 from 11:00 a.m.1:00 p.m.

ESKAPE Pathogen Program:

  • AAR Late Breaking Poster LB12 - Advanced Pyrrolocytosine Leads are Potent in vitro against Enterobacteriaceae Expressing the Plasmid-Mediated Colistin-Resistance Gene, mcr-1; June 8 from 11:00 a.m.1:00 p.m.
  • AAR Late Breaking Poster LB14 - Advanced Pyrrolocytosine Leads are Potent in vitro against the Multiple Resistance Mechanisms Present in the CDC Enterobacteriaceae Carbapenemase Diversity Panel; June 8 from 11:00 a.m.1:00 p.m.
  • Poster 566 - Pyrrolocytosines: A Completely New Class of Antibiotics with Potent Efficacy against Biothreat Pathogens; June 8 from 11:00 a.m.1:00 p.m.

Solithromycin:

  • Poster 549 - In vivo Activity of Solithromycin and Levofloxacin against a Murine Pneumonia Mixed-Infection Model Caused by Streptococcus Pneumoniae and Anaerobic Bacteria; June 9 from 11:00 a.m.1:00 p.m.

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

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Source: Melinta Therapeutics

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