- Clinical program successfully completed to support regulatory applications and potential approval in the U.S. and EU
- Pre-NDA meetings with FDA confirm clear path to submission
- Rolling submission of NDA to begin in December 2017; NDA submission completion expected in the first quarter of 2018
- Conference call scheduled for 8:30 a.m. EDT on Wednesday, August 2, 2017
BOSTON, Aug. 02, 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 June 30, 2017.
"The successful completion of our planned clinical program for omadacycline and our recent pre-NDA meetings with the FDA represent important strategic milestones on our pathway to approval,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “We believe that omadacycline represents a much-needed new antibiotic treatment option in an era of rising bacterial resistance. With the data generated to date in all three Phase 3 studies, we remain confident in the path to regulatory approval in both the U.S. and EU. Based on our recent pre-NDA meetings with FDA, we will initiate our rolling submission in December of this year.”
- Reported positive top-line efficacy, safety, and tolerability data in the OPTIC study, a Phase 3 registration study of IV to once-daily oral omadacycline in community-acquired bacterial pneumonia (CABP)
- Reported positive top-line efficacy, safety, and tolerability data in the OASIS-2 study, a Phase 3 registration study of once-daily oral-only omadacycline in acute bacterial skin and skin structure infections (ABSSSI)
- Completed two pre-NDA meetings, focused on clinical/non-clinical and CMC topics, with the U.S. Food and Drug Administration confirming our plans for NDA submission
- Received endorsement of the Pediatric Investigation Plan from the European Medicines Agency
- Presented 10 posters and oral presentations at American Society of Microbiology’s ASM Microbe 2017 conference in New Orleans
- Expanded our commercial, medical and drug supply teams
- Strengthened balance sheet, extending runway through Q2 2019, including full cost of product launch
- Presentation of omadacycline data at the ID Week conference, October 4-8 in San Diego
- Investor Day on October 17, 2017 in New York City
Paratek reported a net loss of $18.2 million, or $0.66 per share, for the quarter ended June 30, 2017 compared to a net loss of $30.3 million, or $1.69 per share, for the same period in 2016.
Revenue during the quarter ended June 30, 2017 reflects a $7.5 million upfront license fee earned under a License and Collaboration Agreement with Zai Lab (Shanghai) Co., Ltd., or Zai Collaboration Agreement as well as fifty percent of net royalties received pursuant to a separate royalty sharing agreement. The Company did not record revenue during the quarter ended June 30, 2016.
Research and development expenses were $15.1 million for the quarter ended June 30, 2017 compared to $22.1 million for the same period in 2016. The decrease was driven primarily by lower clinical study costs as the Company neared completion of its planned Phase 3 omadacycline program.
General and administrative expenses were $8.7 million for the quarter ended June 30, 2017 compared to $7.6 million for the same period in 2016. The increase was driven primarily by higher employee compensation costs as the Company continued to expand its team.
As of June 30, 2017, Paratek had cash, cash equivalents, and marketable securities of $175.3 million. During the quarter ended June 30, 2017, the company raised proceeds of $58.5 million. These include $41.8 million raised through sales of common stock under controlled equity offering agreements through May 1, 2017, as previously announced in the Company’s Form 10-Q for the quarter ended March 31, 2017.
Additionally, the Company amended its loan agreement with Hercules to extend the interest-only period for one year, through December 2019, contingent on successful NDA approval and to make an additional $10.0 million in principal available, bringing the total amount available to $60.0 million. Concurrent with the amendment, the Company drew $10.0 million of principal to bring its outstanding debt balance to $49.0 million, which is presented net of debt issuance costs.
Finally, the Company also received $6.7 million, which is net of applicable taxes paid, for the upfront license fee earned under the Zai Collaboration Agreement.
Based on current assumptions, including full commercial buildout and launch of omadacycline, Paratek’s cash, cash equivalents and marketable securities 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 June 30, 2017 will be broadcast at 8:30 a.m. EDT on August 2, 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 13665445. Investors can also access the call at http://public.viavid.com/index.php?id=125152.
Replays of the call will be available through August 16, 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 13665445.
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. 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 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|
|Six months ended|
|License and royalty revenue||$||7,514||$||—||$||7,532||$||—|
|Research and development||15,079||22,135||33,735||46,423|
|General and administrative||8,716||7,602||17,080||13,941|
|Impairment of intangible asset||682||—||682||—|
|Changes in fair value of contingent consideration||(318||)||15||(549||)||120|
|Total operating expenses||24,159||29,752||50,948||60,484|
|Loss from operations||(16,645||)||(29,752||)||(43,416||)||(60,484||)|
|Other income and expenses:|
|Other (loss) income, net||(8||)||(1||)||(15||)||(1||)|
|Loss before income taxes||$||(17,430||)||$||(30,283||)||$||(45,099||)||$||(61,554||)|
|Provision for income taxes||753||—||753||—|
|Net loss per share - basic and diluted||$||(0.66||)||$||(1.69||)||$||(1.78||)||$||(3.47||)|
|Weighted average common shares outstanding|
|Basic and diluted||27,347,941||17,895,301||25,780,756||17,755,528|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and marketable securities||$||175,338||$||128,038|
|Total current liabilities||15,025||20,412|
|Long-term debt, less current portion||48,975||38,974|
|Common stock and additional paid-in-capital||540,375||451,970|
|Total stockholders' equity||113,384||71,592|
CONTACTS: Media: Michael Lampe Scient Public Relations (484) 575-5040 firstname.lastname@example.org Investors: Hans Vitzthum LifeSci Advisors, LLC. 212-915-2568