- Granted QIDP designation for uncomplicated Urinary Tract Infections (uUTI) by the FDA
- Highlighted prelaunch activities during Investor Day presentations in October
BOSTON, Nov. 08, 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 and provided an update on financial, clinical and regulatory filing activities for the quarter ended September 30, 2017.
“Following the successful completion of our clinical development program for omadacycline in skin infections and pneumonia in July, the third quarter included increased activities around the preparation of our NDA filing package for submission to the FDA as well as expanded pre-commercialization activities in anticipation of product approval,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “In parallel, we continued to advance plans for our Phase 2 program in urinary tract infections. The granting of Qualified Infectious Disease Product designation for omadacycline for the potential treatment of uUTI is an acknowledgement by the FDA of the important need for new broad-spectrum oral agents for this indication.”
- Granted Qualified Infectious Disease Product (QIDP) Designation for an additional indication in uUTI by the FDA
- Nine posters and one oral presentation at IDWeek 2017 in San Diego
- Presented omadacycline clinical profile, market landscape, and pre-commercial activities at Investor Day on October 17
- Initiation of rolling NDA submission for omadacycline
- Initiation of Phase 2 program of omadacycline in UTI
Paratek reported a net loss of $21.3 million, or ($0.77) per share, for the quarter ended September 30, 2017 compared to a net loss of $23.6 million, or ($1.04) per share, for the same period in 2016.
Research and development expenses were $12.1 million for the quarter ended September 30, 2017 compared to $17.3 million for the same period in 2016. The decrease was driven primarily by lower clinical study costs associated with the completion of our Phase 3 program for omadacycline.
General and administrative expenses were $8.2 million for the quarter ended September 30, 2017 compared to $5.9 million for the same period in 2016. The increase was driven primarily by higher employee compensation costs as we continue to expand our team and engage in pre-commercial activities.
As of September 30, 2017, Paratek had cash, cash equivalents, and marketable securities of $163.4 million. Based on current assumptions, including full commercial buildout and launch of omadacycline, Paratek’s cash, cash equivalents and marketable securities, remaining debt capacity, and anticipated regulatory and commercial milestone payments from our existing collaboration partners will enable the Company to fund operating expenses and capital expenditure requirements through the second quarter of 2019.
Conference Call and Webcast
Paratek’s earnings conference call for the quarter ended September 30, 2017 will be broadcast at 8:30 a.m. EDT on November 8, 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 13671638. Investors can also access the call at http://public.viavid.com/index.php?id=126484.
Replays of the call will be available through November 22, 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 13671638.
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. The Company’s lead product candidate, omadacycline, is a new, once-daily oral and intravenous broad-spectrum antibiotic being developed for the treatment of serious community-acquired bacterial infections, including community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and urinary tract infections. 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 of ABSSSI, CABP, uUTI and cUTI. Paratek has completed Phase 3 development activities for omadacycline in CABP and ABSSSI and is preparing to submit marketing applications in the United States and European Union. Paratek has licensed rights for omadacycline to Zai Lab for the greater China region, and retains all remaining global rights.
Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.
Paratek's second Phase 3 product candidate, sarecycline, is being developed by Allergan in the U.S. as a new once-daily oral therapy for the treatment of acne. Allergan has completed Phase 3 development activities for sarecycline and is preparing a new drug application for submission to the U.S. Food and Drug Administration. Paratek retains all ex-U.S. rights to sarecycline.
Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
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||Nine Months Ended|
|September 30,||September 30,|
|License and royalty revenue||$||12||$||—||$||7,544||$||—|
|Research and development||12,112||17,334||45,847||63,757|
|General and administrative||8,219||5,949||25,299||19,896|
|Impairment of intangible asset||—||—||682||—|
|Changes in fair value of contingent consideration||(22||)||(170||)||(571||)||(50||)|
|Total operating expenses||20,309||23,113||71,257||83,603|
|Loss from operations||(20,297||)||(23,113||)||(63,713||)||(83,603||)|
|Other income and expenses:|
|Other (loss) income, net||(8||)||(4||)||(23||)||1|
|Loss before income taxes||$||(21,324||)||$||(23,628||)||$||(66,423||)||$||(85,182||)|
|Provision for income taxes||—||—||753||—|
|Net loss per share - basic and diluted||$||(0.77||)||$||(1.04||)||$||(2.54||)||$||(4.39||)|
|Weighted average common shares outstanding|
|Basic and diluted||27,776,218||22,627,711||26,453,219||19,391,443|
Condensed Consolidated Balance Sheets
|September 30, ||December 31,|
|Cash, cash equivalents and marketable securities||$||163,440||$||128,038|
|Total current liabilities||15,797||20,412|
|Long-term debt, less current portion||49,079||38,974|
|Common stock and additional paid-in-capital||548,172||451,970|
|Total stockholders' equity||99,872||71,592|
|Media Relations:||Investor Relations:|
|Michael Lampe||Hans Vitzthum|
|(484) 575-5040||LifeSci Advisors, LLC.|