On July 16, 2019 Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, reported preliminary and unaudited financial results and provided a corporate update for the second quarter ended June 30, 2019 (Press release, Cempra, JUL 16, 2019, View Source [SID1234537564]).

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"Melinta’s preliminary second quarter 2019 results demonstrate that the actions taken to improve upon the Company’s operational and financial efficiencies are continuing to drive progress," said John H. Johnson, chief executive officer of Melinta. "As we enter into the third quarter of 2019, we remain focused on driving sales efforts, preparing for the potential Baxdela (delafloxacin) community-acquired bacterial pneumonia (CABP) approval and launch, while also continuing to identify additional ways to reduce expenses. We believe in the strength of our long-term strategy to best position Melinta for future success and remain committed to delivering upon our mission of leading the global fight against antimicrobial resistance and providing antibiotic solutions to patients and healthcare providers."

Preliminary Second Quarter 2019 Financial Results
Melinta anticipates that it will report net product sales of approximately $13.8 million for the second quarter of 2019, which is an increase of 51 percent over the second quarter of 2018 and an increase of 17 percent over the first quarter of 2019.

Melinta also expects to report quarter-end cash and cash equivalents of approximately $90 million, and the Company is targeting to reduce full-year 2019 operating expenses by approximately $70 million.

The figures in the foregoing sentences are all based upon preliminary estimates and remain subject to change as the Company finalizes its results for the second quarter of 2019.
The Company will announce its full second quarter 2019 financial results on August 7, 2019 at 8:30 a.m. ET and plans to host a conference call at that time.

Recent Corporate Updates

On July 10, The World Health Organization (WHO) added Vabomere (meropenem and vaborbactam) to its Essential Medicines List for its ability to target multidrug-resistant infections caused by pathogens deemed a "critical priority" by the WHO, including carbapenem-resistant Enterobacteriaceae

The U.S. Food and Drug Administration (FDA) recently accepted for priority review a supplemental New Drug Application (sNDA) for Baxdela (delafloxacin) seeking to expand the current indication to include adult patients with community-acquired bacterial pneumonia (CABP); the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of October 24, 2019

Sixteen scientific presentations and posters of portfolio and pipeline data have been accepted for presentation at the Infectious Diseases Society of America IDWeek 2019 meeting, being held October 1 – 6, 2019 in Washington, D.C. and at the American College of Chest Physicians (ACCP) CHEST Meeting, being held October 19 – 23, 2019 in New Orleans, LA

Second Quarter 2019 Conference Call and Webcast
Melinta’s earnings conference call for the second quarter of 2019 will be broadcast at 8:30 a.m. ET on August 7, 2019. Investors wishing to participate in the call should dial: 877-377-7553 and international investors should dial: 253-237-1151, using the conference ID# 5166674. A live webcast of the call will be available online from the Investor Relations section of the company website at www.melinta.com and will be archived there for 30 days. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID# 5166674.