- Completed enrollment in Phase 3 ABSSSI study
- Faster-than-projected enrollment in Phase 3 CABP study
- Initiated dosing in Phase 1b UTI study
- Conference call scheduled for 8:30 a.m. EDT on May 3, 2016
BOSTON, May 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 March 31, 2016.
"Our clinical development program for omadacycline continues to progress well. We completed enrollment in March for our Phase 3 registration study of omadacycline in the treatment of acute bacterial skin and skin structure infections. We expect to report top-line data from this study as early as the end of this June. The second ongoing study in our Phase 3 registration program is for the treatment of community-acquired bacterial pneumonia. We are pleased to report that enrollment of this study is currently ahead of our initial projections; as such we are now expecting top-line data from this study as early as the third quarter of 2017,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “We are also pleased to report that we have now initiated our Phase 1b study with omadacycline for the treatment of urinary tract infections.”
Recent Paratek Highlights
- Completed enrollment in the company’s Phase 3 registration study evaluating omadacycline for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in March 2016, ahead of original projected timeline
- Faster-than-projected enrollment to date in the second Phase 3 registration study evaluating omadacycline for the treatment of community-acquired bacterial pneumonia (CABP). Enrollment for this study commenced in November 2015
- Initiated dosing in a Phase 1b study evaluating omadacycline for the treatment of urinary tract infections
- Readout of top-line data from pivotal Phase 3 registration study evaluating omadacycline for the treatment of ABSSSI expected as early as late June 2016
- Readout of top-line data from pivotal Phase 3 registration study evaluating omadacycline for the treatment of CABP now expected as early as the third quarter of 2017
For the quarter ended March 31, 2016, Paratek reported a net loss of $31.3 million, or $1.78 per share, compared to a net loss of $10.6 million, or $0.74 per share, for the same period in 2015.
Research and development expenses were $24.3 million for the quarter ended March 31, 2016, compared to $6.7 million for the same period in 2015. The increase in research and development expense during the quarter ended March 31, 2016 was primarily the result of our ongoing clinical development of omadacycline. During the current quarter, we incurred approximately $14.4 million in expense associated with our Phase 3 studies of ABSSSI and CABP, an increase of $12.9 million compared to $1.5 million in the same period in prior year. This increase is associated primarily with faster-than-projected enrollment performance in both of the ABSSSI and CABP registration studies, resulting in an acceleration of related CRO fees, investigator fees, and costs associated with clinical sites and laboratories. This acceleration in the recognition of these expenses does not affect the aggregate expense levels from these studies, and as such does not affect our overall cash runway. The remainder of the increase represents additional production costs for omadacycline registration batches, salaries and benefits, including stock-based compensation, due to increased headcount, and costs from omadacycline Phase 1 studies.
General and administrative expenses were $6.3 million for the quarter ended March 31, 2016, compared to $4.3 million for the same period in 2015. The increase in general and administrative costs for the quarter ended March 31, 2016 was primarily the result of salaries and benefits, including stock-based compensation, commensurate with the increase in headcount.
As of March 31, 2016, Paratek had cash, cash equivalents, and marketable securities of $112.3 million. Based on current assumptions, Paratek’s cash, cash equivalents and marketable securities are expected to fund operations through the read-out of top-line results from our second Phase 3 registration study, which is anticipated as early as the third quarter of 2017.
Conference Call and Webcast
Paratek’s earnings conference call for the quarter ended March 31, 2016, will be broadcast at 8:30 a.m. EST on May 3, 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 using conference ID 13635898. International investors should dial: 877-407-9039 using conference ID 13635898. Investors can also access the call at http://public.viavid.com/index.php?id=119309.
Replays of the call will be available through May 17, 2016. Domestic investors can access the replay by dialing 877-870-5176. International investors can access the replay by dialing 858-384-5517. The PIN code to access the replay is 13635898.
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. Paratek completed enrollment in a Phase 3 registration study in ABSSSI in March 2016 to determine the efficacy and safety of omadacycline compared to linezolid. Top-line data from this study is expected to be available as early as the end of June 2016. A Phase 3 registration study for CABP comparing omadacycline to moxifloxacin was initiated in November 2015 and top-line data is now expected as early as the third quarter of 2017. Paratek initiated a Phase 1b study of omadacycline in urinary tract infections in May 2016. Omadacycline has been granted 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, complicated urinary tract infections (cUTI), 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 new once-daily oral tetracycline-derived compound for the potential treatment of acne and rosacea in the community setting. Sarecycline is designed to be a well-tolerated, once-daily oral, narrow spectrum antibiotic with anti-inflammatory properties. 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.
For more information, visit www.paratekpharma.com. 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.
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, (v) the timing of the commencement of omadacycline Phase 3 trials for CABP, (vi) 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, (vii) the potential of omadacycline to become the primary antibiotic choice of physicians for the treatment of serious community-acquired bacterial infections, (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 commencement of a 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 Quarterly Report on Form 10-Q for the quarter ended March 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 collaborations||$||-||$||-|
|Research and development||24,288||6,741|
|General and administrative||6,339||4,271|
|Impairment of intangible asset||-||2,761|
|Changes in fair value of contingent consideration||105||(3,140||)|
|Total operating expenses||30,732||10,633|
|Loss from operations||(30,732||)||(10,633||)|
|Other income and expenses:|
|Other income, net||3||-|
|Other loss, net||(3||)||-|
|Net loss per share - basic and diluted||$||(1.78||)||$||(0.74||)|
|Weighted average common shares outstanding|
|Basic and diluted||17,615,754||14,418,145|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and marketable securities||$||112,263||$||131,302|
|Total current liabilities||25,987||20,502|
|Total stockholders' equity||73,139||101,240|
CONTACTS: Media: Michael Lampe Scient Public Relations (484) 575-5040 firstname.lastname@example.org Investors: Hans Vitzthum LifeSci Advisors, LLC 212-915-2568