BOSTON, April 2, 2015 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), today reported financial results for the year ended December 31, 2014.
"We have ended 2014 and our first quarter as a public company well positioned to execute against our clinical development plans, and we are actively advancing our lead antibiotic candidate, omadacycline, into two Phase 3 clinical trials in acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). We believe we are adequately resourced through the unblinding of the top line results of our Phase 3 ABSSSI trial, which we currently expect to occur in the third quarter of 2016," said Michael Bigham, Chief Executive Officer.
Mr. Bigham added: "Omadacycline is a novel once-daily intravenous and oral, tetracycline-derived, broad-spectrum antibiotic being developed for use as monotherapy for patients suffering from serious community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Given the increasingly favorable regulatory and legislative environments, coupled with the growing recognition of the rising unmet medical need in the antibiotic resistant space by the scientific, medical, pharmaceutical, investment and media communities, we believe Paratek is well positioned to achieve our near-term corporate objectives. We look forward to reporting on our continued progress throughout the year."
Year ended December 31, 2014 compared to year ended December 31, 2013
For the year ended December 31, 2014, Paratek reported a net loss of $19.8 million, or $7.82 per share, compared to a net loss of $11.4 million, or $185.13 per share, for the year ended December 31, 2013.
Revenue in 2014 was $4.3 million, consisting of a $4.0 million milestone payment from Actavis Plc earned during the fourth quarter for the start of a Phase 3 clinical trial for sarecycline and recognition of $0.3 million in deferred revenue upon the termination of a collaborative research, development and commercialization agreement with a leading global animal health provider. Revenue in 2013 was $0.5 million, consisting of research and development revenue earned under various collaborations.
Research and development expense for 2014 was $5.0 million, an increase of $0.4 million compared to the year ended December 31, 2013. The change was due to an increase in compensation, recruiting and other personnel-related costs and preparation for planned Phase 3 clinical trials. General and administrative expense for 2014 was $5.8 million, a $2.5 million increase compared to the year ended December 31, 2013 primarily due to an increase in professional and consulting services, compensation and other personnel-related costs, and insurance premiums. Merger-related third-party costs of $1.3 million were also incurred during 2014.
At December 31, 2014, Paratek had cash and cash equivalents of $95.9 million. The increase compared to December 31, 2013 was primarily due to gross proceeds from the $93.0 million subscription agreement that closed on October 30, 2014, concurrent with a reverse merger with Transcept Pharmaceuticals, and available cash from Transcept's balance sheet at the time of the merger. Based on current assumptions, the company's cash and cash equivalents are expected to fund operations through the unblinding of the top line results of our Phase 3 ABSSSI trial, which we anticipate in the third quarter of 2016.
Fourth Quarter 2014 and early 2015 Highlights
- Closed a subscription agreement raising $93.0 million for newly issued common stock in October 2014
- Consummated its reverse merger transaction in October 2014. The merged company began trading on the NASDAQ exchange under ticker symbol "PRTK"
- Adam Woodrow joined Paratek as Chief Commercial Officer in October 2014
- Douglas Pagán joined Paratek as Chief Financial Officer in December 2014
- Actavis initiated a Phase 3 clinical trial for Acne in December 2014, triggering a $4.0 million milestone payment to Paratek
Clinical program update
Paratek is focused on the development of its lead clinical-stage antibiotic candidate, omadacycline, the intravenous and oral antibiotic being developed for ABSSSI and CABP. Paratek currently expects the following clinical development milestones related to omadacycline to occur this year:
Mid-2015: Initiation of ABSSSI Phase 3 patient enrollment
Late-2015: Initiation of CABP Phase 3 patient enrollment
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 a new tetracycline-derived, broad-spectrum antibiotic being developed in both oral tablet and intravenous formulations for use as a first-line monotherapy antibiotic for ABSSSI, CABP, UTI and other serious community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has received Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration for both the oral and intravenous formulations in all three of these infectious disease categories. Paratek has Special Protocol Assessment agreements with the FDA for the phase 3 trials planned in ABSSSI and CABP.
Paratek's second product candidate, sarecycline, also known as WC 3035, is a new tetracycline-derived compound, designed to provide both a narrow-spectrum of antibiotic activity and favorable tolerability profile, for the treatment of acne and rosacea in the community setting. Paratek has licensed rights to sarecycline for the treatment of acne in the United States to a subsidiary of Actavis, formerly Warner Chilcott, while retaining rights in the rest of the world. Actavis is responsible for the clinical development of sarecycline for the treatment of acne in the United States. A phase 3 program was initiated by Actavis in December 2014 for sarecycline for the treatment of moderate to severe acne.
Please Note: This press release contains forward-looking statements including statements related to our overall strategy, the design, conduct, progress timing and results of our clinical trials, the sufficiency of our cash resources. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements, 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 anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to our need for substantial additional funding to complete the development and commercialization of our product candidates, risks related to our ability to raise the capital that we believe to be accessible and is required to fully finance the development and commercialization of our product candidates, statements relating to our ability to develop our drug candidates for potential commercialization, the timing of the commencement of omadacycline phase 3 trials for ABSSSI and CABP, 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, the potential of omadacycline to become the primary antibiotic choice of physicians for the treatment of serious community-acquired bacterial infections, including ABSSSI, CABP and UTI, the potential use and effectiveness of sarecycline for the treatment of acne and rosacea in the community setting, and the timing of the commencement of a phase 3 program in moderate-severe acne for sarecycline, the risk that data to date and trends may not be predictive of future data or results, risks related to the conduct of our clinical trials, and the risk that our clinical trials may not lead to 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, 2014, when available and our other filings with the Securities and Exchange Commission. Paratek expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Paratek's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
|PARATEK PHARMACEUTICALS, INC.|
|SELECTED FINANCIAL INFORMATION|
|Condensed Consolidated Statements of Operations|
|(in thousands, except loss per share data)|
| Year Ended |
| Year Ended |
|Revenue||$ 4,342||$ 478|
|Research and development||5,014||4,631|
|General and administrative||5,848||3,387|
|Total operating expenses||12,140||8,018|
|Loss from operations||(7,798)||(7,540)|
|Non-operating (expense) income, net||(10,037)||2,887|
|Unaccreted dividends on convertible preferred stock||(1,927)||(6,766)|
|Net loss attributable to common stockholders||$ (19,762)||$ (11,419)|
|Net loss per share, basic and diluted||$ (7.82)||$ (185.13)|
|Weighted average common shares outstanding, basic and diluted||2,529||62|
|Condensed Consolidated Balance Sheets|
|As of December 31,|
|Cash||$ 95,856||$ 1,212|
|Working capital (deficiency)||97,588||(33,577)|
|Long-term obligations, less current portion||11,002||224|
|Convertible preferred stock||—||80,565|
|Common stock and additional paid-in capital||293,090||65,698|
|Total stockholders' equity (deficit)||$ 95,224||$ (114,333)|
CONTACT: Media Relations: Michael Lampe (484) 575-5040 firstname.lastname@example.org Investor Relations: Hans Vitzthum LifeSci Advisors, LLC. 212-915-2568Source:Paratek Pharmaceuticals