December 08, 2016 10:24 PM ET

Biotechnology

Company Overview of Galena Biopharma, Inc.

Company Overview

Galena Biopharma, Inc., a biopharmaceutical company, focuses on developing and commercializing oncology therapeutics that address major unmet medical needs. The company’s lead product candidate, NeuVax (nelipepimut-S), is in Phase III clinical trials for the prevention of recurrence in early- stage and node-positive breast cancer with low to intermediate human epidermal growth factor receptor (HER2) expression; Phase IIb clinical trials in combination with Herceptin for HER2 1+/2+ node-positive and high-risk node-negative breast cancer treatment; and Phase II clinical trials in combination with trastuzumab for node positive and negative HER2 IHC 3+ patients. It also develops GALE-301 (folate...

2000 Crow Canyon Place

Suite 380

San Ramon, CA 94583

United States

Founded in 2003

22 Employees

Phone:

855-855-4253

Fax:

925-498-7700

Key Executives for Galena Biopharma, Inc.

Chief Executive Officer, President and Director
Age: 61
Total Annual Compensation: $874.2K
Chief Medical Officer and Executive Vice President
Age: 54
Total Annual Compensation: $166.7K
Interim General Counsel and Corporate Secretary
Age: 63
Total Annual Compensation: $212.3K
Compensation as of Fiscal Year 2015.

Galena Biopharma, Inc. Key Developments

Galena Biopharma, Inc. Presents at Virtual Investor Conference 2016, Dec-01-2016 01:45 PM

Galena Biopharma, Inc. Presents at Virtual Investor Conference 2016, Dec-01-2016 01:45 PM. Speakers: Mark W. Schwartz, Chief Executive Officer, President and Director.

Galena Biopharma Presents GALE-301/GALE-302 Phase 1b Data at the Society for Immunotherapy of Cancer Conference 2016

Galena Biopharma, Inc. announced that data from Galena’s GALE-301/GALE-302 clinical program was presented at the Society for Immunotherapy of Cancer Conference 2016 in National Harbor, Maryland. GALE-301 (E39) and GALE-302 (E39’ – variant of E39) are cancer immunotherapies that consist of a peptide derived from Folate Binding Protein (FBP) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in the adjuvant setting. The Phase 1b is a single-center, randomized, single-blinded, three-arm study in patients with breast or ovarian cancer diagnosis who were treated with standard of care and showed no evidence of disease at enrollment. This trial augments the Phase 1/2a trial with single-agent GALE-301 in ovarian and endometrial cancers. Previous trials have demonstrated that although boosting vaccinations help to maintain long-lasting immunity, attenuated peptides may be a better choice for boosting because over-stimulation with an immunogenic peptide may lead to cytotoxic T lymphocyte (CTL) exhaustion and death. This phenomenon is known as antigen-induced cell death. The presentation, entitled, “Phase Ib Trial of Two Folate Binding Protein (FBP) Peptide Booster Vaccines (E39 and E39') in Breast and Ovarian Cancer Patients,” reported the peptide-specific immune response to E39 and E39' after different combinations of vaccination and boosting. Both E39 and E39' are well tolerated with all related adverse events at grade 1 or grade 2. Though numbers were small, patients boosted with the attenuated peptide showed increased CTL response to boosting regardless of significant residual immunity (SRI) resulting from the primary vaccination series (PVS). While this data needs to be confirmed with a larger sample size, this is consistent with the theoretical advantage of boosting with an attenuated peptide, which is expected to induce less antigen-induced cell death of CTLs. Ex-vivo immunologic recognition of E39 was assessed by clonal expansion of CTLs and in-vivo response by delayed-type hypersensitivity (DTH). Immunologic data was gathered at 1- and 6-months post-booster and was then analyzed. The 6-month post-PVS immunologic data was used to assess patients for SRI, defined as =2-fold increase from pre-PVS in E39-specific CD8+T-cells. Patients were sorted into two groups: those with SRI (SRI) and without (nSRI). Patients within each group were randomized to one booster of either E39’ or E39 resulting in four groups: SRI receiving E39 (SRI-E39), SRI receiving E39' (SRI-E39'), nSRI receiving E39 (nSRI-E39), nSRI receiving E39' (nSRI-E39'). Sixteen patients were found to have SRI and 12 had nSRI; these patients were randomized to booster arms (SRI-E39:n=9; SRI-E39':n=7; nSRI-E39:n=7; nSRI-E39':n=5). There were no clinicopathologic differences between groups. When comparing DTH pre-booster and at 1- and 6- months post-booster there were no significant differences between SRI vs nSRI (p=0.350, p=0.276, p=0.133, respectively), E39 vs. E39' (p=0.270, p=0.329, p=0.228), nor between all four groups (p=0.394, p=0.555, p=0.191). Comparing the change in CTL’s from pre- and 6-months post-booster, regardless of SRI, patients boosted with E39’ had increased CTL (+0.02) while those boosted with E39 had decreased CTL (-0.07, p=0.077). There was no difference comparing the change in DTH between groups (p=0.927). HLA-A2-positive breast or ovarian cancer patients were enrolled after completion of standard of care and without evidence of disease, regardless of FBP expression level. The PVS includes six inoculations, one every 3-4 weeks containing 250mcg GM-CSF plus 500mcg peptide in the first five patients per arm (n=14) and 250mcg GM-CSF + 1000mcg of peptide in the second five patients (n=16). Thirty-nine patients were randomized into three arms with 30 breast (n=27) or ovarian (n=3) cancer patients completing the PVS and assessed for this presentation: E39 (GALE-301) x 6 inoculations (n=10), E39 (GALE-301) x 3 inoculations followed by E39’ (GALE-302) x 3 inoculations (n=10) and E39’ (GALE-302) x 3 inoculations followed by E39 (GALE-301) x 3 inoculations (n=10).

Galena Biopharma, Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2016

Galena Biopharma, Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2016. Operating loss from Galena’s development programs and general and administrative expenses, classified as continuing operations, during the three months ended September 30, 2016 was $6.5 million, including $0.5 million in non-cash stock-based compensation, compared to an operating loss from continuing operations of $8.6 million, including $0.6 million in non-cash stock-based compensation for the same period in 2015. Loss from continuing operations for third quarter of 2016 was $4.3 million, or $0.02 per basic and diluted share, including $2.1 million in non-operating income, compared to $6.4 million, or $0.04 per basic and diluted share, including $2.3 million non-operating income a year ago. Net loss for third quarter of 2016 was $6.9 million, or $0.03 per basic and diluted share, compared to net loss of $18.0 million, or $0.11 per basic and diluted share, for the same period of 2015. Operating loss for the first nine months of 2016 was $24.7 million, including $1.8 million in non-cash stock-based compensation, compared to an operating loss from continuing operations of $26.6 million, including $1.3 million in non-cash stock-based compensation for the same period in 2015. Loss from continuing operations for the first nine months of 2016 was $9.2 million, or $0.05 per basic and diluted share, including $15.6 million in non-operating income. Loss from continuing operations for the first nine months of 2015 was $28.2 million, or $0.18 per basic and diluted share, including $1.5 million in non-operating expense. Net loss for the first nine months of 2016 was $18.0 million, or $0.10 per basic and diluted share, compared to $44.2 million, or $0.29 per basic and diluted share, for the same period of 2015.

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Recent Private Companies Transactions

Type
Date
Target
Private Placement
May 10, 2016
--
Merger/Acquisition
December 18, 2015
Galena Biopharma, Inc., Certain Assets
 

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