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BURLINGTON, Mass., Aug. 6, 2015 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced financial results for the second quarter ended June 30, 2015.
"In the last several months, the team at Flexion has taken important steps to advance our lead program, FX006 (an intra-articular, sustained release steroid for the treatment of patients with moderate to severe OA knee pain) toward a potential New Drug Application (NDA) filing in 2016," said Michael Clayman, M.D., Flexion Therapeutics President and Chief Executive Officer. "We recently completed enrollment in our second pivotal trial (Phase 3) for the product candidate and expect to announce top-line pivotal data from our Phase 2b clinical trial in September. Also, we added Patheon as a second contract manufacturer, in addition to Evonik Corporation, to expand our manufacturing capacity for the planned commercialization of the compound."
Second-Quarter Financial Results
The company reported a net loss of $12.4 million for the second quarter of 2015, compared to a net loss of $5.9 million for the second quarter of 2014.
Research and development expenses were $9.6 million in the second quarter of 2015, compared to $3.6 million for the same period in 2014, due to an increase in FX006 program expenses related to the pivotal Phase 2b and Phase 3 clinical trials and higher expenses related to manufacturing scale-up.
General and administrative expenses were $2.9 million in the second quarter of 2015, as compared to $2.2 million for the same period in 2014, due primarily to increases in salary and related costs associated with increased headcount, including stock based compensation expense.
For the six months ended June 30, 2015, the company reported a net loss of $21.6 million, compared to a net loss of $12.5 million for the same period in 2014.
Research and development expenses were $15.9 million for the six months ended June 30, 2015 compared to $7.8 million for the same period in 2014, due to an increase in FX006 program expenses related to the pivotal Phase 2b and Phase 3 clinical trials and higher expenses related to manufacturing scale-up. Increases in salary and other employee related costs, including stock compensation expense, also contributed to the higher spending level.
General and administrative expenses were $5.7 million for the six months ended June 30, 2015 compared to $4.5 million for the same period in 2014, due to salary and related employee costs, including stock compensation expense, due to additional headcount.
As of June 30, 2015, the company had $127.4 million in cash, cash equivalents, and marketable securities compared to $151.6 million as of December 31, 2014.
Second Quarter Highlights and Recent News:
About Flexion Therapeutics
Flexion is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel pain therapies. The company is currently advancing a portfolio of local, injectable drug candidates that have the potential to provide better and more persistent analgesia compared with existing therapy. The company's lead program, FX006, is an intra-articular sustained-release steroid in development for patients with moderate to severe OA pain. The company also has two additional product candidates, FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients.
At 4:30 p.m. ET today, Flexion's management will host a conference call and webcast to review the Company's first quarter financial results and provide a general business update. The dial-in number for the conference call is (855) 770-0022 for domestic participants and (908) 982-4677 for international participants, with Conference ID # 92908008. A live webcast of the conference call can also be accessed through the "Investors" tab on the Flexion Therapeutics website at www.flexiontherapeutics.com. A webcast replay will be available online after the call.
Statements in this press release regarding matters that are not historical facts, including statements relating to the future of Flexion; its ongoing development of its product candidates; expected timing and results of the ongoing Phase 2b clinical trial, the DoD-funded Phase 2 clinical trial, and the ongoing Phase 3 clinical trial; plans and timing for regulatory submissions; anticipated clinical and other milestones (including the timing of such milestones); and potential benefits of FX006, are forward-looking statements. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics, the fact that results of past clinical trials may not be predictive of subsequent trials, the fact that Flexion relies on third parties to manufacture and conduct the clinical trials of its product candidates, which could delay or limit their future development or regulatory approval, the fact that Flexion will require additional capital, including prior to commercializing FX006 or any of its other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to it, the risk that Flexion's patents may be challenged or invalidated, and other risks and uncertainties described in Flexion's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Flexion's Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent filings with the SEC. You are encouraged to read Flexion's filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and Flexion undertakes no obligation to update or revise any of the statements.
|CONDENSED STATEMENT OF OPERATIONS|
|(in thousands, except for per share information)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Revenue||$ --||$ --||$ --||$ --|
|Research and development||9,640||3,615||15,895||7,766|
|General and administrative||2,904||2,234||5,664||4,518|
|Loss from operations||(12,544)||(5,849)||(21,559)||(12,284)|
|Interest income (expense), net||440||28||405||(52)|
|Other income (expense)||(333)||(110)||(456)||(137)|
|Loss from operations before income tax||(12,437)||(5,931)||(21,610)||(12,473)|
|Basic and diluted net loss per share||$ (0.58)||$ (0.38)||$ (1.01)||$ (1.07)|
|Basic and diluted weighted average number of common shares outstanding||21,475||15,619||21,463||11,670|
|SELECTED BALANCE SHEET DATA|
|June 30,||December 31,|
|Cash and cash equivalents||$ 28,340||$ 103,098|
|Total current assets||128,795||152,127|
|Total notes payable||--||3,593|
|Total stockholders' equity (deficit)||125,660||144,942|
CONTACT: Media Contact Jamie Lacey-Moreira PressComm PR, LLC T: 410-299-3310 firstname.lastname@example.org Corporate Contact Lisa Davidson, MBA Vice President, Finance and Administration Flexion Therapeutics T: 781-305-7765 email@example.comNEXT ARTICLE
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