- Enrolling Patients in Phase 3 Registration Study of Omadacycline in Community Acquired Bacterial Pneumonia
- Granted FDA Fast Track Status for Omadacycline
- Advancing Phase 3 Registration Study of Omadacycline in Acute Bacterial Skin and Skin Structure Infections According to Plan
BOSTON, Nov. 12, 2015 (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, 2015. This quarter the company reported a net loss attributable to common stockholders of $23.4 million, or $1.33 per share, compared to a net loss attributable to common stockholders of $4.0 million, or $29.48 per share, for the quarter ended September 30, 2014.
"During the third quarter, we continue to make significant progress against our goal of developing omadacycline as a once-daily oral and IV treatment for serious community-acquired bacterial infections," said Michael Bigham, Chairman and Chief Executive Officer, Paratek. "Our clinical development programs are on track, and we are in a strong financial position."
For the quarter ended September 30, 2015, Paratek reported a net loss attributable to common stockholders of $23.4 million, or $1.33 per share, compared to a net loss attributable to common stockholders of $4.0 million, or $29.48 per share, for the same quarter in 2014.
Research and development expenses for the quarter ended September 30, 2015 were $17.8 million, an increase of $16.8 million compared to the same quarter in 2014. The increase is primarily the result of initiation of the company's Phase 3 clinical trials of omadacycline and includes CRO fees, investigator fees and costs associated with clinical sites and laboratories of $12.1 million, manufacturing of clinical material and registration batches of $3.8 million, and personnel-related costs of $1.1 million.
General and administrative expenses for the quarter ended September 30, 2015 were $5.8 million, a $3.7 million increase compared to the same quarter in 2014, primarily due to the growth in corporate infrastructure to support a public company. Salaries and benefits, including stock-based compensation, increased $1.5 million compared to the same quarter in 2014. Professional and consulting fees increased $0.4 million compared to the same quarter in 2014 primarily due to higher legal, finance and accounting, and market research costs.
As of September 30, 2015, Paratek had cash and cash equivalents of $146.4 million, which is expected to fund operations through top-line results from the Phase 3 study of omadacycline for CABP, projected to be available in the second half of 2017.
Clinical & Regulatory Updates
- Paratek began enrolling patients in its Phase 3 registration study of omadacycline in community-acquired bacterial pneumonia (CABP) in November.
- Paratek received Fast Track designation from the U.S. Food and Drug Administration for the oral and IV formulations of omadacycline for the treatment of ABSSSI, CABP, and complicated urinary tract infections (cUTI)
- Enrollment in the ongoing Phase 3 registration study of omadacycline for the treatment of ABSSSI is advancing according to plan.
- If both Phase 3 registration studies are successful, the company anticipates submitting a new drug application in the U.S. in the first half of 2018.
- Paratek's second Phase 3 compound, sarecycline, a once-daily, oral narrow-spectrum antibiotic with anti-inflammatory properties, entered two identical Phase 3 registration studies for the treatment of moderate to severe acne vulgaris in December 2014 through its U.S. partner, Allergan. Allergan has publically stated that this program remains on track, with top-line data expected in 2016 and a potential launch in the U.S. in 2017. Paratek retains ex-U.S. rights to sarecycline.
- In September, Paratek signed a loan and security agreement that provides access to $40.0 million, of which it drew $20.0 million upon closing. These funds will be used for general corporate purposes including support of late-stage clinical development opportunities for oral omadacycline.
Conference Call and Webcast
The company's earnings conference call for the quarter ended September 30, 2015 will be broadcast at 8:30 a.m. EST on November 12, 2015. The webcast will be accessible through the Investors section of www.paratekpharma.com.
Domestic investors wishing to participate in the call should dial: 888-468-2440 using conference ID 1267024. International investors should dial: 719-325-2448, using conference ID 1267024. Investors can also access the call at http://public.viavid.com/player/index.php?id=117166.
Replays of the call will be available through November 26th. 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 1267024.
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 initiated a Phase 3 registration study in ABSSSI in June 2015 to determine the efficacy and safety of omadacycline compared to linezolid. A second Phase 3 registration study for CABP with omadacycline was initiated in November 2015.
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 ABSSSI, CABP, 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. Two identical Phase 3 registration studies were initiated by Allergan in December 2014 for sarecycline for the treatment of moderate to severe acne vulgaris.
For more information, visit www.paratekpharma.com
| PARATEK PHARMACEUTICALS, INC. |
SELECTED FINANCIAL INFORMATION
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except loss per share data)
| Three months ended |
| Nine months ended |
|Research and development collaborations||$ --||$ --||$ --||$ 342|
|Research and development||17,817||1,001||35,556||2,364|
|General and administrative||5,795||2,074||14,347||3,865|
|Impairment of intangible asset||--||--||2,761||--|
|Changes in fair value of contingent consideration||(240)||--||(2,980)||--|
|Total operating expenses||23,372||3,075||49,684||6,229|
|Loss from operations||(23,372)||(3,075)||(49,684)||(5,887)|
|Other income and expenses:|
|Interest expense, net||(47)||(158)||(73)||(714)|
|Loss on mark-to-market of notes and warrants||--||--||--||(119)|
|Other income (expense), net||(2)||--||3||6|
|Unaccreted dividends on convertible preferred stock||--||(745)||--||(1,684)|
|Net loss attributable to common stockholders||$ (23,421)||$ (3,978)||$ (49,754)||$ (8,398)|
|Basic and diluted net loss per common share||$ (1.33)||$ (29.48)||$ (3.08)||$ (91.81)|
|Weighted average common shares outstanding|
|Basic and diluted||17,561,490||135,000||16,128,957||91,484|
| SELECTED FINANCIAL INFORMATION |
Condensed Consolidated Balance Sheets
| September 30, |
| December 31, |
|Working capital (deficiency)||141,381||97,588|
|Total current liabilities||13,606||3,741|
|Long-term obligations, less current portion||26,983||11,002|
|Common stock and additional paid-in capital||367,844||293,090|
|Total stockholders' equity||120,224||95,224|
Forward Looking Statements
The statements in this press release regarding Paratek's belief that its clinical development programs are on track, its expectations that the company's cash and cash equivalents will fund operations through the second half of 2017, which the company expects to coincide with the availability of top-line data from the planned Phase 3 study of omadacycline for CABP, its anticipation that if both studies are successful, the company will be submitting a new drug application in the U.S. in the first half of 2018, and its belief that its sarecycline program remains on track with top-line data expected in 2016 and a potential new drug application in the U.S. in 2017, are forward-looking statements. These forward-looking statements are based upon Paratek's current expectations and involve substantial risks and uncertainties. Paratek may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in these forward-looking statements and you should not place undue reliance on these forward-looking statements. Paratek's 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) Paratek's need for substantial additional funding to complete the development and commercialization of Paratek's product candidates, (ii) Paratek's ability to raise the capital to do so, (iii) the risk that unexpected results will be obtained in the clinical studies, which could delay the reporting of top line data or prevent the completion of the studies; (iv) risks that data to date and trends may not be predictive of future results; and (v) risks that Paratek's clinical studies and product candidates do not receive regulatory approval. These and other risk factors are discussed under "Risk Factors" and elsewhere in Paratek's Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, and Paratek's other filings with the Securities and Exchange Commission. Paratek expressly disclaims any obligation or undertaking to update or revise any forward-looking statements contained herein.
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