- Successfully demonstrated proof-of-principle in a Phase 1b study of oral and IV omadacycline in patients with urinary tract infections (UTI)
- Completed all clinical phase 1 studies and registration batches required for NDA submission
- Company to Host an R&D Day on November 17 in New York City
- Conference call scheduled for 8:30 a.m. EDT on November 2, 2016
BOSTON, Nov. 02, 2016 (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 September 30, 2016. The company also reported the completion and top-line results of a Phase 1b study of omadacycline in patients with urinary tract infections, as well as the completion of several important clinical and manufacturing requirements for its planned NDA submission.
Phase 1b UTI Pharmacokinetic Results
In this clinical study, patients with uncomplicated UTI received either IV-to-oral or oral-only regimens of omadacycline over a period of five days. Results showed that omadacycline achieved high steady state concentrations in urine for all treatment regimens, demonstrating proof-of-principle for the use of omadacycline in UTI.
Clinical & Manufacturing NDA Registration Requirements
The company completed two required Phase 1 pharmacokinetic studies to support the planned regulatory filings for omadacycline.
The first of the two Phase 1 studies assessed the concentration of omadacycline in the lungs via bronchoalveolar lavage (BAL). This study, conducted in healthy volunteer subjects, demonstrated that omadacycline is able to penetrate into the lungs and epithelial lining fluid, at concentrations higher than plasma. The second Phase 1 study evaluated exposure levels of omadacycline in patients with end-stage renal disease. This study found that in these patients, omadacycline had similar pharmacokinetic exposure profiles to healthy subjects, suggesting that omadacycline can be used in subjects with renal impairment without the need for dose adjustments.
All recently completed phase 1 studies demonstrate a safety and tolerability profile consistent with prior oral and IV phase 1 studies of omadacycline.
The company has also completed production of all oral and IV registration batches of omadacycline required for planned regulatory submissions. The registration batches were produced at commercial scale.
"With the continued progress we have made this quarter, we remain on track to file our NDA for both community-acquired skin and pneumonia indications in the first half of 2018,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “Importantly, the promising data from our Phase 1b study in UTI support developing a registration pathway for omadacycline in UTI, the most common community-acquired bacterial infection. In addition to the clinical progress this quarter, we also completed important regulatory requirements that will support our planned NDA. We are pleased with the progress we have made to date, and remain excited about the eventful year ahead.”
Additional Q3 2016 Highlights
- Announced 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
- Initiation of a Phase 3 once-daily, oral-only study in acute bacterial skin and skin-structure infection, or ABSSSI, and remains on track to have top line data available as early as the second quarter of 2017
- Phase 3 IV-to-oral study in community acquired bacterial pneumonia, or CABP, remains on track to have top line data available as early as the third quarter of 2017
Upcoming Milestones
- Hosting an R&D Day on November 17 in New York. More information can be found here http://lifesci.rampard.com/20161117/reg.jsp
Financial Results
For the quarter ended September 30, 2016, Paratek reported a net loss of $23.6 million, or $1.04 per share, compared to a net loss of $23.4 million, or $1.33 per share, for the same period in 2015.
Research and development expense for the quarter ended September 30, 2016 decreased modestly compared to the same period in 2015, primarily due to the completion of our Phase 3 ABSSSI IV-to-oral study. With the commencement of a Phase 3 once-daily, oral-only study in ABSSSI in August 2016 and the initiation of preparation activities for an NDA submission for omadacycline, the Company expects the next several quarters of research and development expense to return to the levels incurred during the first half of 2016.
General and administrative expense for the quarter ended September 30, 2016 is consistent with the same period in 2015. The expense incurred during the quarters ended September 30, 2016 and 2015 were primarily driven by personnel costs, professional and consulting services, including legal, accounting and audit fees, and other administrative spend.
As of September 30, 2016, Paratek had cash, cash equivalents, and marketable securities of $120.8 million. Based on current assumptions, Paratek’s cash, cash equivalents and marketable securities, as well as the $20.0 million available under a Loan Agreement with Hercules, will enable the Company to fund operating expenses and capital expenditure requirements through the submission of a new drug application for omadacycline for the treatment of ABSSSI and CABP, which is currently expected to occur in the first half of 2018.
Conference Call and Webcast
Paratek’s earnings conference call for the quarter ended September 30, 2016, will be broadcast at 8:30 a.m. EST on November 2, 2016. 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 13648499. Investors can also access the call at http://public.viavid.com/index.php?id=121674.
Replays of the call will be available through November 16, 2016. 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 13648499.
Website Information
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 ABSSSI demonstrating the efficacy and safety of intravenous (IV) to oral omadacycline compared to linezolid. A Phase 3 registration study for community acquired bacterial pneumonia (CABP) comparing IV-to-oral omadacycline to IV-to-oral moxifloxacin was initiated in November 2015. Enrollment continues on track to report top line data as early as the third 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 are expected as early as the second quarter of 2017. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration.
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 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 trials, cash resources, prospects and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical trials, 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 trials. 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 our drug candidates for potential commercialization, (iv) the advancement of omadacycline Phase 3 trials for ABSSSI and CABP, (v), (v) the potential for omadacycline to be successfully developed for use as a first-line 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 ability of our supply chain to provide adequate supply to satisfy our clinical and commercial demand (viii) the potential use and effectiveness of sarecycline for the treatment of acne and rosacea in the community setting, and (ix) 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 trials, and risks that our clinical trials 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, 2015, 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 | |||||||||||||
| (unaudited) | |||||||||||||
| (in thousands, except loss per share data) | |||||||||||||
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||
| 2016 | 2015 | 2016 | 2015 | ||||||||||
| Operating expenses: | |||||||||||||
| Research and development | $ | 17,334 | $ | 17,817 | $ | 63,757 | $ | 35,556 | |||||
| General and administrative | 5,949 | 5,795 | 19,896 | 14,347 | |||||||||
| Impairment of intangible asset | - | - | - | 2,761 | |||||||||
| Changes in fair value of contingent consideration | (170 | ) | (240 | ) | (50 | ) | (2,980 | ) | |||||
| Total operating expenses | 23,113 | 23,372 | 83,603 | 49,684 | |||||||||
| Loss from operations | (23,113 | ) | (23,372 | ) | (83,603 | ) | (49,684 | ) | |||||
| Other income and expenses: | |||||||||||||
| Interest expense | (820 | ) | (47 | ) | (2,368 | ) | (73 | ) | |||||
| Interest income | 309 | - | 788 | - | |||||||||
| Other income (expense), net | (4 | ) | (2 | ) | 1 | 3 | |||||||
| Net loss | $ | (23,628 | ) | $ | (23,421 | ) | $ | (85,182 | ) | $ | (49,754 | ) | |
| Net loss per share - basic and diluted | $ | (1.04 | ) | $ | (1.33 | ) | $ | (4.39 | ) | $ | (3.08 | ) | |
| Weighted average common shares outstanding | |||||||||||||
| Basic and diluted | 22,627,711 | 17,561,708 | 19,391,443 | 16,129,031 | |||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| September 30, 2016 | December 31, 2015 | |||||||
| (unaudited) | ||||||||
| Cash, cash equivalents and marketable securities | $ | 120,792 | $ | 131,302 | ||||
| Total assets | 131,611 | 145,918 | ||||||
| Working capital | 105,707 | 121,915 | ||||||
| Total current liabilities | 21,751 | 20,502 | ||||||
| Long-term debt, less current portion | 19,653 | 19,565 | ||||||
| Total stockholders' equity | 85,472 | 101,240 | ||||||