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Share Name | Share Symbol | Market | Type |
---|---|---|---|
SELLAS Life Sciences Group Inc | NASDAQ:SLS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.07 | -4.61% | 1.45 | 1.44 | 1.46 | 1.545 | 1.4217 | 1.53 | 1,292,450 | 00:53:47 |
Mark W. Schwartz, Ph.D., President and Chief Executive Officer, commented, "We are providing this update today to set the stage for what we believe will be a strong 2015 for Galena Biopharma. On the commercial side, I reiterate our 2014 guidance as we had our best sales quarter to date, and expect net revenues to fall in the middle of our $8-$10 million range. Further, we expect Abstral® to become accretive in 2015 and, with the launch of Zuplenz®, we expect over 50% revenue growth this year."
Schwartz continued, "NeuVax™, our lead cancer immunotherapy agent, has a portfolio of trials providing diversification and increased potential of program success. Our Phase 3 PRESENT trial is expected to enroll the 700th patient near the end of January and complete over enrollment near the end of the first quarter. We also expect top-line data and the determination of next steps for the GALE-301 and GALE-401 Phase 2 programs. While 2014 was a challenging year for Galena, this did not impede the advancement of our two commercial programs and three clinical assets, all of which are poised for significant progress in 2015."
2015 Outlook:
Galena expects to reach a number of key milestones this year across its multiple programs.
Commercially, the Company anticipates a strong year for sales growth along with the launch of a second asset:
Galena's targeted cancer immunotherapy programs are designed to prevent recurrence in breast, gastric, ovarian and endometrial cancers. As the number of cancer survivors continues to grow, preventing recurrence of the disease becomes more important as metastatic tumors are most often fatal. Galena's programs harness the power of the immune system and primarily target patients in the adjuvant (after-surgery) setting who have relatively healthy immune systems. Employing this approach, the company is currently engaged in multiple clinical trials with NeuVax™ (nelipepimut-S) and GALE-301, or Folate Binding Protein, combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF).
Galena's lead development asset is NeuVax, which is designed to prevent recurrence in breast and gastric cancers targeting the HER2 protein, one of the more common proteins expressed with these diseases. The company has developed a portfolio of trials with a number of key collaborators and in multiple indications where there are currently no approved treatments:
Galena's second immuno-oncology compound, GALE-301 targets folate binding protein receptor-alpha, a well-validated therapeutic target, which is highly over-expressed in ovarian, endometrial and breast cancers. GALE-301 is in a Phase 2a clinical trial for the prevention of recurrence in ovarian and endometrial cancers. Current treatments for these diseases are principally with chemotherapeutic agents and patients suffer a high recurrence rate; and, most patients relapse with an extremely poor prognosis.
Galena's final clinical program is a hematology compound known as GALE-401, or Anagrelide Controlled Release. GALE 401 is currently in a Phase 2 proof-of-concept clinical trial for the reduction of elevated platelet counts in patients with thrombocythemia, secondary to myeloproliferative neoplasms (MPNs). Phase 2 top-line safety and efficacy data will be presented this year.
Herceptin is a registered trademark of Genentech/Roche. NeuVax and Abstral are trademarks of Galena Biopharma. All other trademarks are the property of their respective owners.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company's commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena's clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects. For more information, visit www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the commercialization of Abstral® and development of Galena's product candidates, including patient enrollment in our clinical trials, as well as statements about our expectations, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in Galena's Annual Report on Form 10-K for the year ended December 31, 2013 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.
CONTACT: Remy Bernarda VP, Marketing & Communications (503) 405-8258 rbernarda@galenabiopharma.com
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