- Advanced timing for top-line data readout of Phase 3 study of omadacycline in community-acquired bacterial pneumonia (CABP)
- Conference call scheduled for 8:30 a.m. EST on March 2, 2017
BOSTON, March 02, 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 full year and quarter ended December 31, 2016.
"We made excellent progress with the clinical development program of omadacycline in the fourth quarter and continued our work to prepare for a potential NDA submission in the first half of 2018,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “With the enrollment of the pneumonia study now complete, we expect to release top-line data early in the second quarter. Our Phase 3 study of an oral-only dosing regimen in skin infections is progressing well. We continue to expect top-line data as early as the second quarter of this year from this study.”
- Announced completion of enrollment of CABP study and data readout planned for early second quarter 2017
- Hosted Company’s first R&D day – highlighting new data for omadacycline in UTI and lung concentrations
- Completed three successive registration batches of omadacycline IV and oral drug product and placed these batches on stability testing
- Continued to progress Phase 3 study of oral-only omadacycline in acute bacterial skin and skin structure infections (ABSSSI) with top-line data expected as early as the second quarter of 2017
- Announced a new cooperative research effort with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to study omadacycline against biodefense pathogens
- Promoted Evan Loh to Chief Operating Officer
- Drew an additional $20 million from existing debt line with Hercules Technology Growth Capital and signed an amendment extending the interest only period of the loan until December 2018 and establishing an additional tranche of $10 million available on clinical success in either of two ongoing omadacycline Phase 3 studies
- Presentation of omadacycline IV-to oral ABSSSI clinical study results at ECCMID, April 22-25 in Vienna, Austria
- Readout of top-line data from the IV-to-oral CABP study
- Readout of top-line data presentation from the oral-only ABSSSI study
- Readout of top-line data from Allergan’s Phase 3 program of sarecycline for the treatment of acne vulgaris
Fourth Quarter and Full Year 2016 Financial Results
For the fourth quarter of 2016, Paratek reported a net loss of $26.5 million, or $1.16 per share, compared to a net loss of $21.1 million, or $1.20 per share, for the same period in 2015. For the year ended December 31, 2016, Paratek reported a net loss of $111.6 million, or $5.51 per share, compared to a net loss of $70.9 million, or $4.29 per share, for the same period in 2015.
Research and development expenses were $19.7 million and $83.5 million for the quarter and year ended December 31, 2016, respectively, compared to $15.2 million and $50.8 million for the same periods in 2015. The increase in research and development expense for the year ended December 31, 2016 was primarily the result of ongoing development of omadacycline, including costs associated with clinical studies for the treatment of ABSSSI, CABP and UTI, production of omadacycline registration batches and manufacturing process validation work, other research and development activities, and employee compensation.
General and administrative expenses were $6.5 million and $26.4 million for the quarter and year ended December 31, 2016, respectively, compared to $5.6 million and $20.0 million for the same periods in 2015. The increase in general and administrative costs was primarily the result of employee compensation.
As of December 31, 2016, Paratek had cash, cash equivalents, and marketable securities of $128.0 million. Based on current assumptions, Paratek’s cash, cash equivalents and marketable securities will enable the Company to fund operating expenses and capital expenditure requirements through the first half of 2018.
Paratek initiated sales of shares under a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. in March 2016, and sold an aggregate of 860,014 shares of common stock through December 31, 2016, resulting in net proceeds of $11.6 million. As of February 24, 2017, an additional 870,078 shares were sold under the Sales Agreement subsequent to December 31, 2016, resulting in net proceeds of $13.1 million, which will be recognized during the first quarter of 2017.
Conference Call and Webcast
Paratek’s earnings conference call for the quarter ended December 31, 2016, will be broadcast at 8:30 a.m. EST on March 2, 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 877-407-9039 and international investors should dial 201-689-8470. The conference ID is 13656270. Investors can also access the call at http://public.viavid.com/index.php?=123110.
Replays of the call will be available through March 16, 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 13656270.
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, is the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. 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 safety of intravenous (IV) to once-daily oral omadacycline compared to linezolid. A Phase 3 registration study for community-acquired bacterial pneumonia (CABP) comparing IV-to-once-daily oral omadacycline to IV-to-oral moxifloxacin was initiated in November 2015 and completed enrollment in January 2017. Paratek will report top-line data from this study early in the second quarter of 2017. 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. Top-line data from this study are expected as early as the second quarter of 2017. A Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data were reported in November 2016. The company plans to begin enrolling patients in a proof-of-concept Phase 2 study in complicated UTI as early as the fourth quarter of 2017. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for several indications.
In October 2016, Paratek announced a new cooperative research effort with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to study omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance. These studies are designed to confirm dosing regimens and assess efficacy of omadacycline against biodefense pathogens, including Yersinia pestis (plague) and Bacillus anthracis (anthrax).
Omadacycline is a new once-daily oral and IV, well-tolerated 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.
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 initiated two identical Phase 3 registration studies in December 2014 for sarecycline for the treatment of moderate to severe acne vulgaris. Top-line Phase 3 data are expected in the first 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, cash resources, prospects and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical 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 having the resources to execute on our clinical studies. 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, which include, without limitation, risks related to (i) our need for substantial additional funding to complete the development and commercialization of our product candidates, (ii) our ability to raise the capital to do so, (iii) our ability to develop and manufacture our drug candidates for potential commercialization, (iv) the advancement of omadacycline Phase 3 studies for ABSSSI, (v) the potential for omadacycline to be successfully developed for use as an empiric monotherapy for patients suffering from serious community-acquired bacterial infections, (vi) the potential of omadacycline to become the primary antibiotic choice of physicians for the treatment of serious community-acquired bacterial infections, (vii) the potential use and effectiveness of sarecycline for the treatment of acne and rosacea in the community setting, and (viii) the timing of the Phase 3 program in moderate-severe acne for sarecycline, risks that data to date and trends may not be predictive of future results, risks related to the conduct of our clinical studies, and risks that our clinical studies and product candidates do not receive regulatory approval. 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||19,703||15,209||83,460||50,765|
|General and administrative||6,504||5,641||26,400||19,988|
|Impairment of intangible assets||—||99||—||2,860|
|Changes in fair value of contingent consideration||(289||)||(580||)||(345||)||(3,560||)|
|Total operating expenses||25,918||20,369||109,515||70,053|
|Loss from operations||(25,889||)||(20,369||)||(109,486||)||(70,053||)|
|Other income and expenses:|
|Other gains (and losses), net||3||(40||)||4||(37||)|
|Basic and diluted net loss per common share||$||(1.16||)||$||(1.20||)||$||(5.51||)||$||(4.29||)|
|Weighted average common shares outstanding|
|Basic and diluted||22,819,268||17,608,615||20,253,082||16,501,912|
|Condensed Consolidated Balance Sheets|
|As of December 31,|
|Cash, cash equivalents and marketable securities||$||128,038||$||131,302|
|Long-term obligations, less current portion||43,728||24,176|
|Common stock and additional paid-in capital||451,970||369,966|
|Total stockholders’ equity||71,592||101,240|
CONTACTS: Media: Michael Lampe Scient Public Relations (484) 575-5040 email@example.com Investors: Hans Vitzthum LifeSci Advisors, LLC. 212-915-2568