- Reported positive Phase 3 study results with omadacycline in community-acquired bacterial pneumonia (CABP)
- Updated timing to submit regulatory application with U.S. FDA to as early as first quarter 2018
- Conference call scheduled for 8:30 a.m. EDT on Thursday, May 4, 2017
BOSTON, May 04, 2017 (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 for the quarter ended March 31, 2017.
"The announcement of positive top-line data in April from our successful Phase 3 registration study in pneumonia was a critically important milestone in the development of omadacycline,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “Together, this study and our previously announced successful Phase 3 study in skin infections satisfy the regulatory filing requirements of our special protocol assessments with the FDA. Our plan is to submit for regulatory approval in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018. In addition, we recently announced a collaboration with Zai Lab to develop, manufacture and commercialize omadacycline for the greater China region. We also recently made thirteen presentations on omadacycline, including two oral sessions, at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).”
- Reported positive top-line efficacy and safety data in the OPTIC study, a Phase 3 registration study of omadacycline in CABP
- Enrollment nearly completed in the OASIS-2 study, a Phase 3 registration study of oral-only omadacycline in acute bacterial skin and skin structure infections (ABSSSI) with top-line data now expected by mid-July
- Narrowed the projected window to submit the New Drug Applications for the oral and IV formulations with the U.S. Food and Drug Administration from as early as the first half 2018 to as early as the first quarter 2018
- Presented 11 posters and 2 oral sessions at ECCMID in Vienna, Austria
- Signed a license and collaboration agreement with Zai Lab for omadacycline in the People’s Republic of China, Hong Kong, Macau, and Taiwan
- Reported positive top-line data from Allergan’s Phase 3 program of sarecycline for the treatment of acne vulgaris
- Readout of top-line data from the oral-only ABSSSI study, OASIS-2
- Presentation of omadacycline data at the American Society for Microbiology conference, June 1-5 in New Orleans
Paratek reported a net loss of $27.7 million, or $1.14 per share, for the quarter ended March 31, 2017 compared to a net loss of $31.3 million, or $1.78 per share, for the same period in 2016.
Research and development expenses were $18.7 million for the quarter ended March 31, 2017 compared to $24.3 million for the same period in 2016. The decrease was primarily driven by lower clinical study costs and reduced manufacturing production costs for omadacycline.
General and administrative expenses were $8.4 million for the quarter ended March 31, 2017 compared to $6.3 million for the same period in 2016. The increase was primarily driven by an increase in consulting and legal fees, employee compensation costs, and other administrative expenses.
As of March 31, 2017, Paratek had cash, cash equivalents, and marketable securities of $139.6 million. Based upon Paratek’s current operating plan, the Company anticipates that its existing cash, cash equivalents and marketable securities, the remaining $10.0 million it may borrow under existing debt arrangements, proceeds to be received under its existing controlled equity offering agreements, and anticipated upfront and regulatory milestone payments from its collaborations with Allergan and Zai will enable the Company to fund its operating expenses and capital expenditure requirements into the second quarter of 2019.
Conference Call and Webcast
Paratek’s earnings conference call for the quarter ended March 31, 2017 will be broadcast at 8:30 a.m. EDT on May 4, 2017. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek’s website at www.paratekpharma.com.
Domestic investors wishing to participate in the call should dial: 877-407-0792 and international investors should dial: 201-689-8263. The conference ID is 13660676. Investors can also access the call at http://public.viavid.com/index.php?id=124062.
Replays of the call will be available through May 18, 2017. Domestic investors can access the replay by dialing 844-512-2921 and international investors can access the replay by dialing 412-317-6671. The PIN code to access the replay is 13660676.
Paratek routinely posts important information for investors on the Investor Relations section of its website at www.paratekpharma.com. Paratek intends to use this website as a means of disclosing material, non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Paratek’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Paratek’s website is not incorporated by reference into, and is not a part of, this document.
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. Paratek's lead product candidate, omadacycline, when approved, will be the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. 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.
In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and general safety and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy and general safety and tolerability of IV to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. Enrollment of this study is nearly complete, with top-line data from this study expected by mid-July. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018.
In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017.
In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax.
In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a License and Collaboration Agreement. Under the terms of the Agreement, the Company granted Zai an exclusive license to develop, manufacture, and commercialize omadacycline in the People’s Republic of China, Hong Kong, Macau and Taiwan, for all human therapeutic and preventative uses, other than biodefense. Zai will be responsible for the development, manufacturing and commercialization of the licensed product in the licensed territory, at its sole cost with certain assistance from the Company.
Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017.
For more information, visit www.paratekpharma.com.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2016, and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.
|PARATEK PHARMACEUTICALS, INC.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except loss per share data)|
|Three months ended|
|Research and development||18,657||24,288|
|General and administrative||8,363||6,339|
|Changes in fair value of contingent consideration||(231||)||105|
|Total operating expenses||26,789||30,732|
|Loss from operations||(26,771||)||(30,732||)|
|Other income and expenses:|
|Other (loss) income, net||(7||)||—|
|Net loss per share - basic and diluted||$||(1.14||)||$||1.78|
|Weighted average common shares outstanding|
|Basic and diluted||24,196,158||17,615,754|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and marketable securities||$||139,587||$||128,038|
|Total current liabilities||18,635||20,412|
|Long-term debt, less current portion||39,060||38,974|
|Common stock and additional paid-in-capital||493,576||451,970|
|Total stockholders' equity||84,809||71,592|
CONTACTS: Media: Michael Lampe Scient Public Relations (484) 575-5040 firstname.lastname@example.org Investors: Hans Vitzthum LifeSci Advisors, LLC. 212-915-2568