Galena Biopharma (GALE) Offers Outlook for 2016; Expects to Meet Multiple Cancer Immunotherapy Milestones

Galena Biopharma, Inc. (NASDAQ: GALE) provided the Company’s outlook for 2016.

Mark W. Schwartz, Ph.D., President and Chief Executive Officer, commented, “Galena’s strategy to advance our high value cancer immunotherapy clinical development pipeline has resulted in a progression to eight clinical trials ongoing or planned that are supportive of our core focus. Importantly, we expect to reach two key milestones in 2016 with the readout of our NeuVax™ (nelipepimut-S) Phase 3 PRESENT interim safety and futility analysis in the second quarter and the launch of a randomized, Phase 2b trial for GALE-301/302 in the second half of the year.”

Dr. Schwartz continued, “The advances in the immunotherapy field reinforce the importance of our approach, and we are pleased with our position as the leader in developing therapies to prevent cancer recurrence. Our programs are first-in-class in their respective indications and we believe are in very strong competitive positions. Most prominently, we are treating women in areas where there are no approved targeted therapies and where there is a very high unmet medical need to prevent their cancer from returning. Our immunotherapy assets have a proven mechanism of action and we believe we have selected the right patient populations to achieve success. And, as we have done successfully thus far, we will continue to seek collaborations to leverage our financial resources and further advance our assets into other indications.”

Dr. Schwartz added, “Consistent with our strategic focus, we are bolstering our leadership team to provide critical expertise as we begin to prepare for the potential submission of a Biologics License Agreement (BLA) for NeuVax. Last quarter, Dr. Bijan Nejadnik joined us as our Chief Medical Officer having previously worked at Jazz Pharmaceuticals and Johnson & Johnson. We have also enlisted a national executive recruiting firm to lead the search for two new members for our Board of Directors and an experienced Chief Financial Officer. We expect to make significant clinical progress over the course of the year and look forward to having additional experience and perspective at the highest levels of the company.”

Dr. Schwartz concluded, “I would also like to address our recent financial offering that allowed us to secure our cash balance for the year. While our ongoing, anticipated cash burn including current and planned clinical trials is expected to be between $11 to 13 million per quarter, we will also have non-recurring expenses as a result of the previously announced commercial divesture and settlement of the outstanding litigation. As such, it was important for us to enhance our balance sheet ahead of our expected milestones to ensure the company remains financially strong over the course of 2016.”

2016 Outlook:

Galena expects to achieve a number of key milestones this year across its novel cancer immunotherapy programs. Effective immunotherapy treatment is associated with high numbers of cytotoxic T-Cells (CTLs), and it has been shown that increasing tumor specific CTLs is critical for overcoming many of the challenges associated with some of the current immunotherapy treatments. Galena’s peptide based vaccines, NeuVax and GALE-301/302, have demonstrated, in multiple trials, they can effectively induce, activate and expand CTLs.

Galena’s vaccines harness the power of the patient’s immune system to seek out and destroy any residual, or occult, cancer cells via their proven mechanism of action stimulating T-Cell proliferation and expansion. The Company’s current programs are designed to prevent recurrence in breast, gastric, and ovarian cancers in the adjuvant setting where patients have relatively healthy immune systems. As the number of cancer survivors continues to grow, preventing recurrence of the disease becomes more important as metastatic tumors are most often fatal.

Employing this approach, the company is currently engaged in multiple clinical trials with NeuVax and GALE-301/302 combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF).

Galena’s lead development asset, NeuVax, has several milestones upcoming for 2016:

• 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 fully enrolled and is expected to reach two key milestones in the first half of the year. In the first quarter, the trial should see the 70th patient event, which is defined as a recurrence or death from any cause. Once this occurs, the Independent Data Safety and Monitoring committee will evaluate the data and provide the company with the safety and futility interim analysis. This analysis is expected in the second quarter.
• The company expects to initiate a Phase 2 trial in patients with Ductal Carcinoma in Situ (DCIS) in the first quarter. This trial is being run in partnership with the National Cancer Institute.
• For the Phase 2b randomized, combination trial with NeuVax and trastuzumab, Galena expects to present interim safety data as well as patient immunology data on the A24 and A25 Human Leukocyte Antigen (HLA) status in the fourth quarter.

Galena’s second immuno-oncology program consists of two assets, GALE-301 and GALE-302, targeting folate binding protein receptor-alpha, a well-validated therapeutic target in ovarian cancer. Based on positive data from the clinical programs, Galena plans the following:

• Initiate a randomized, Phase 2b trial in ovarian cancer in the second half of this year based upon promising data from two ongoing trials: the GALE-301 Phase 2a clinical trial and the GALE-301/GALE-302 Phase 1b trial.
• Present GALE-301/302 booster data in the second quarter.
• Present GALE-301 Phase 2a, two-year data in the fourth quarter.

Galena’s final clinical program is a hematology compound known as GALE-401, or Anagrelide Controlled Release. GALE-401 has completed its Phase 2 proof-of-concept clinical trial for the reduction of elevated platelet counts in patients with thrombocythemia, secondary to myeloproliferative neoplasms (MPNs). The Company plans to publish the final Phase 2 report and confirm the 505(b)2 pathway with the U.S. Food and Drug Administration in the second half of the year.

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