BOSTON, May 09, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today reported financial results and provided an update on financial, clinical, commercial and regulatory filing activities for the quarter ended March 31, 2018.

“The positive momentum we generated in 2017 continued into the first quarter of 2018. The FDA accepted the omadacycline New Drug Applications for priority review with an anticipated approval in October. We continued to advance our commercial readiness activities toward a first quarter 2019 launch and significantly strengthened our balance sheet, which we believe provides the Company the needed capital to fund a successful U.S. launch of omadacycline,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “We also showcased the efficacy of omadacycline against relevant pathogens in life-threatening infections such as community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections at the recent European Congress of Clinical Microbiology and Infectious Diseases meeting. Our significant presence there included nine posters and the first oral presentation of the results of OASIS-2, our Phase 3 oral-only study of omadacycline in skin infections.”

Recent Highlights

• New drug applications (NDAs) for the once-daily oral and intravenous formulations of omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI) accepted for priority review by U.S. Food and Drug Administration (FDA).
• Continued commercial readiness activities, including advancement of manufacturing validation and commercial product supply and expansion of the medical affairs and payer account management teams in preparation for payer formulary discussions.
• Significant presence at European Congress of Clinical Microbiology and Infectious Diseases in Madrid, Spain with nine posters and the first oral presentation of the results of OASIS-2, our Phase 3 oral-only study of omadacycline in skin infections.
• First of two Phase 2 studies of omadacycline in urinary tract infections (UTI) currently enrolling patients.
• Strengthened balance sheet
  • Raised $49.8 million in net proceeds through a registered underwritten public offering of common stock in January.
  • Raised $158.8 million in net proceeds through the issuance of convertible senior subordinated notes in April that will mature on May 1, 2024.
• Appointed Rolf Hoffmann to our Board of Directors. With over 30 years of broad global biopharmaceutical executive experience including senior U.S. and international commercial roles with Amgen, Mr. Hoffmann adds proven commercial experience to the Board.

Upcoming Milestones

• Company preparing for an advisory committee meeting, expected in late summer 2018, to review omadacycline applications.
• Prescription Drug User Fee Act (PDUFA) Action Date for omadacycline in October 2018.
• Company remains on track to submit the marketing authorization for omadacycline in Europe in the second half of 2018.
• Company expects to initiate second Phase 2 study in the second half of 2018.
  • Phase 2 UTI data expected in the second half of 2019.
• PDUFA action date for sarecycline expected in the second half of 2018.

First Quarter 2018 Financial Results For the first quarter of 2018, Paratek reported a net loss of $27.8 million, or $0.91 per share, compared to a net loss of $27.7 million, or $1.14 per share, for the same period in 2017.

Research and development expenses were $14.9 million for the first quarter of 2018, compared to $18.7 million for the first quarter of 2017. The decrease was primarily driven by lower clinical study costs, offset by an increase in manufacturing production costs for omadacycline.

General and administrative expenses were $11.9 million for the first quarter of 2018 compared to $8.4 million for the first quarter of 2017. The increase was primarily due to additional headcount, higher marketing, market access and other commercial costs related to commercial launch preparation activities.

As of March 31, 2018, Paratek had cash, cash equivalents, and marketable securities of $184.3 million. Based on current assumptions, including full commercial buildout and launch of omadacycline, Paratek’s existing capital resources as well as the $158.8 million in net proceeds from the Company’s April 2018 issuance of convertible senior subordinated notes, future contingent regulatory and commercial milestone payments from collaborations with Allergan and Zai Lab, and estimated omadacycline product sales will enable Paratek to fund operating expenses and capital expenditure requirements through the first quarter of 2021.

About Paratek Pharmaceuticals, Inc.

Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. The Company’s lead product candidate, omadacycline, is a new, once-daily oral and intravenous broad-spectrum antibiotic being developed for the treatment of serious community-acquired bacterial infections, including community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and urinary tract infections (UTI). Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications of ABSSSI, CABP, and UTI. Paratek has completed Phase 3 development activities for omadacycline in CABP and ABSSSI, and its New Drug Applications to the U.S. FDA have been accepted for priority review. The Company plans to submit a marketing authorization in the European Union in the second half of this year. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region, and retains all remaining global rights.

Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.

Paratek's second product candidate, SEYSARA™ (sarecycline), is being developed by Allergan in the U.S. as a new once-daily oral therapy for the treatment of acne. Allergan has completed Phase 3 development activities for Seysara and its new drug application was accepted for review by the U.S. FDA in December 2017. Paratek retains all ex-U.S. rights to sarecycline.

Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.

For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.