- Reported positive Phase 3 study results with omadacycline in acute bacterial skin and skin structure infections
- Accelerated timing to report top-line data of the omadacycline Phase 1b urinary tract infection study to Q4 2016
- Raised $59.3 million through underwritten equity offering
- Conference call scheduled for 8:30 a.m. EDT on August 4, 2016
BOSTON, Aug. 04, 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 June 30, 2016.
"Our clinical development program for omadacycline continues to progress well. We have successfully completed our Phase 3 registration study in Acute Bacterial Skin and Skin Structure infections (ABSSSI), and our Phase 3 study in community acquired bacterial pneumonia (CABP) continues to progress according to plan. With our progress to date, we remain on track to file a new drug application for omadacycline in the United States in the first half of 2018,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “In parallel, we are continuing to expand the potential clinical applications of omadacycline. Enrollment in our Phase 1b study with omadacycline for the treatment of urinary tract infections (UTI) is nearly complete, with top-line data expected in Q4; and we expect to initiate enrollment this month in our Phase 3 study with omadacycline for the oral-only treatment of ABSSSI.”
Recent Paratek Highlights
- Announced successful achievement of the primary and secondary efficacy endpoints comparing omadacycline to linezolid in the treatment of ABSSSI. Omadacycline met both the U.S. Food and Drug Administration (FDA)-specified primary efficacy endpoint of early clinical response as well as the European Medicines Agency (EMA)-specified co-primary efficacy endpoint for post-treatment evaluation.
- Phase 3 registration study evaluating omadacycline for the treatment of CABP remains on track to report top-line data as early as the third quarter of 2017.
- Dosing of first patient in oral-only Phase 3 study evaluating omadacycline for the treatment of ABSSSI expected in August 2016.
- Announcement of top-line data from Phase 1b study evaluating omadacycline for the treatment of UTI expected in the fourth quarter of 2016. Enrollment in this study is nearly complete.
For the quarter ended June 30, 2016, Paratek reported a net loss of $30.3 million, or $1.69 per share, compared to a net loss of $15.7 million, or $0.96 per share, for the same period in 2015.
Research and development expenses were $22.1 million for the three months ended June 30, 2016, compared to $11.0 million for the same period in 2015. The increase in research and development expense during the three months ended June 30, 2016 was primarily the result of the Company’s ongoing clinical development of omadacycline, notably from its Phase 3 studies for the treatment of CABP and ABSSSI, a Phase 1b study for the treatment of UTI, and other Phase 1 studies required for submission of the planned New Drug Application.
During the current quarter, the Company incurred approximately $11.4 million in expense associated with its Phase 3 studies for the treatment of ABSSSI and CABP, including a Phase 3 oral-only study, which represents an increase of $4.5 million compared to $6.9 million in the same period in the prior year. This increase is associated primarily with strong enrollment in the CABP registration study, resulting in an increased recognition of expenses related to contract research organization fees, investigator fees, and costs associated with clinical sites and laboratories, as well as study start-up costs for a planned Phase 3 oral-only study in ABSSSI. The Company also incurred $2.3 million in production costs for omadacycline registration batches and manufacturing process validation work, which represents an increase of $0.9 million compared to the same period in prior year.
Also during the quarter, the Company incurred $5.9 million in costs from omadacycline Phase 1 studies and other research and development activities and $2.5 million in salaries and benefits, including stock-based compensation, which represents an increase of $4.6 million and $1.1 million, respectively, compared to the same period in prior year, due to the conduct of additional Phase 1 studies and increased headcount.
The increase in general and administrative costs for the three months ended June 30, 2016 was primarily due to growth in the Company’s corporate infrastructure. Salaries and benefits, including stock-based compensation, increased $1.9 million, and professional and consulting services, including legal, accounting, and audit fees, increased $1.1 million for the three months ended June 30, 2016 compared to the same period in prior year.
As of June 30, 2016, Paratek had cash, cash equivalents, and marketable securities of $150.4 million. Based on current assumptions, Paratek’s cash, cash equivalents and marketable securities, as well as the $20.0 million available to us under the 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 the Company currently expects to occur in the first half of 2018.
Conference Call and Webcast
Paratek’s earnings conference call for the quarter ended June 30, 2016, will be broadcast at 8:30 a.m. EST on August 4, 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: 201-689-8470 using conference ID 13641904. Investors can also access the call at http://public.viavid.com/index.php?id=120479.
Replays of the call will be available through August 18, 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 13641904.
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 data in a Phase 3 registration study in ABSSSI demonstrating the efficacy, safety and tolerability of the once-daily oral and IV formulations of omadacycline compared to linezolid. A Phase 3 registration study for community acquired bacterial pneumonia (CABP) comparing omadacycline to moxifloxacin was initiated in November 2015 and top line data is expected as early as the third quarter of 2017. A phase 1b study in uncomplicated urinary tract infections (uUTI) was initiated in May 2016. Omadacycline has been granted QIDP 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.
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 studies for ABSSSI, (v) the advancement of omadacycline Phase 3 study 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 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|
|(in thousands, except loss per share data)|
|Three months ended|
|Six months ended|
|Research and development||22,135||10,998||46,423||17,739|
|General and administrative||7,602||4,281||13,941||8,552|
|Impairment of intangible asset||-||-||-||2,761|
|Changes in fair value of contingent consideration||15||400||120||(2,740||)|
|Total operating expenses||29,752||15,679||60,484||26,312|
|Loss from operations||(29,752||)||(15,679||)||(60,484||)||(26,312||)|
|Other income and expenses:|
|Other income (loss), net||(1||)||5||(1||)||5|
|Net loss per share - basic and diluted||$||(1.69||)||$||(0.96||)||$||(3.47||)||$||(1.71||)|
|Weighted average common shares outstanding|
|Basic and diluted||17,895,301||16,372,694||17,755,528||15,400,819|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and marketable securities||$||150,403||$||131,302|
|Total current liabilities||28,494||20,502|
|Long-term debt, less current portion||19,625||19,565|
|Total stockholders' equity||106,456||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