Galena Biopharma (GALE) Guides FY15 Below Consensus Expectations

January 8, 2015 7:08 AM EST
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Galena Biopharma (NASDAQ: GALE) provided the Company's outlook for 2015.

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:

  • 2014 Net revenue expected in the middle of the established range of $8-$10 million with year-end and fourth quarter earnings to be announced in March.
  • Upcoming launch of Zuplenz® (ondansetron) oral soluble film in the United States to treat nausea and vomiting caused by chemotherapy, radiation therapy, and following surgery.
  • Achieve $15-18 million net revenue in 2015. As penetration of Abstral® (fentanyl) sublingual tablets continues to grow to treat patients with breakthrough cancer pain, the Company expects the product to become accretive this year.

*** Current FY15 estimates call for revs of $18.97 million and loss of $0.31 per share.

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:

  • The pivotal, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study is expected to reach its protocol established enrollment of 700 patients near the end of this month. Galena expects to over enroll and complete enrollment of the trial near the end of the first quarter of this year. This trial is being run under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA) and, if successful, expected to be the basis for approval of the compound. The interim analysis for safety and futility for the PRESENT trial is expected by the end of 2015/beginning of 2016.
  • Two Phase 2 trials are also being run with NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche). A Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ patients is ongoing under a clinical collaboration with Genentech/Roche and the Henry M. Jackson Foundation. Late last year, the initiation of a Phase 2 trial was announced in neoadjuvant, node positive and negative HER2 IHC 3+ patients. The trial is partially funded via a grant from the Department of Defense under the Congressionally Directed Medical Research Program.
  • Through collaboration with Dr. Reddy's Laboratories, Inc., a fourth trial of NeuVax is expected to initiate this year in gastric (stomach) cancer in India. Gastric cancer is one of the leading causes of death in the Asian population, and this trial could significantly expand the potential patient population for NeuVax.

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.

  • Recent preliminary Phase 2a data of GALE-301 plus GM-CSF showed promising results with a 38% reduction in relative risk of recurrence, is well tolerated with primarily Grade 1 and 2 toxicities, and elicits a strong in vivo immune response.
  • Top-line safety and efficacy data will be presented this year.

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.

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