Press Release

Melinta Therapeutics Presents Updates on the Pyrrolocytosine Compound RX-P2382 against ESKAPE Pathogens at ECCMID 2018

April 23, 2018

NEW HAVEN, Conn., April 23, 2018 (GLOBE NEWSWIRE) -- Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, presented findings at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting highlighting data for RX-P2382, an advanced lead investigational compound from the newly developed pyrrolocytosine class. Pyrrolocytosines were specifically designed by Melinta to target previously untapped binding sites on bacterial ribosomes and optimized for activity against today’s “superbugs”.

As reported, RX-P2382 demonstrated strong in vitro activity against all ESKAPE pathogens tested, including extremely-drug- and multidrug-resistant isolates of Escherichia coli (MIC90 0.25-0.5 μg/mL), Klebsiella pneumoniae (0.125-1 μg/mL), Pseudomonas aeruginosa (2-8 μg/mL) and Acinetobacter baumannii (0.5-2 μg/mL); vancomycin-resistant Enterococci (0.06-1 μg/mL) and Staphylococcus aureus (0.06-1 μg/mL); ciprofloxacin-resistant Neisseria gonorrhoeae (0.03-0.25 μg/mL); and carbapenem-resistant Enterobacteriaceae (0.25-2 μg/mL). In addition, RX-P2382 demonstrated efficacy in murine models of infection, including kidney, skin and respiratory infections - as well as peritonitis - caused by S. aureus, K. pneumoniae, S. pneumoniae and E. coli.

“These results, albeit early stage, support the continued development of compounds in the pyrrolocytosine class,” said Erin Duffy, Ph.D., Melinta’s Chief Scientific Officer. “Pyrrolocytosines such as RX‑P2382 are a completely new antimicrobial class that our team created. They bind to the ribosome in a manner unique from currently available classes. They were developed to overcome resistance mechanisms and show activity against bacteria on the CDC’s Urgent and Serious lists.”

Abstracts of the presentations may be found on the ECCMID website and posters will be available on Melinta’s Publications webpage after the conclusion of the Congress’ embargo period. Melinta’s RX-P2382 presentations at ECCMID were 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 the ESKAPE Pathogen Program
Melinta’s ESKAPE pathogen program is built on the Company’s technology platform based on Nobel laureate science developed at Yale University. Melinta owns the exclusive licenses to the three-dimensional structure of the ribosome and has created the drug-design tools and associated discovery process to exploit the ribosome structure. With these, the Company is able both to improve on existing classes and to design and optimize completely new classes of antibiotics. In the ESKAPE pathogen program, Melinta has created three new classes of antibiotics that inhibit the bacterial ribosome, binding in a validated site that is not the home to commercially available antibiotics. In addition to utilizing this novel binding site, these new classes are also chemically novel; these two features offer a potential advantage vis-à-vis resistance development. Compounds in the lead class, known as the pyrrolocytosines, have been optimized to enhance bacterial influx and to minimize bacterial efflux and have been shown to be active in many preclinical models of efficacy. Compounds in this class represent many potential target product profiles, including for infections caused by drug-resistant Neisseria gonorrhoeae, carbapenem-resistant Enterobacteriaceae (CRE) and the full complement of ESKAPE pathogens, which are multidrug- and extremely-drug-resistant Enterococcus faecium, Staphylococcus aureus (MRSA), Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter sp. and Escherichiacoli.

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

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