Follow the Money to Bio/Pharmaceutical Opportunities
Spotlight on Galena Biopharma, Inc.

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Follow the Money to Bio/Pharmaceutical Opportunities highlights a newly funded bio/pharmaceutical company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities.

Galena Biopharma is a U.S. public bio/pharmaceutical company that develops targeted oncology treatments to address unmet medical needs that advance cancer care. It has raised $12.6 million in a secondary public offering, as reported in the PharmSource Lead Sheet on July 14, 2016.

Corporate Highlights

  • Galena Biopharma was founded in 2006.
  • Corporate Headquarters: San Ramon, CA – approximately 8,100 square feet of office space.
  • As of March 10, 2016, they had 22 employees.
  • Stock Exchange: NASDAQ
  • Stock Symbol: GALE

Sourcing Opportunities

  • Galena Biopharma plans to use the proceeds to support clinical trials of its pipeline, possibly including:
    • GALE-301 – To complete a Phase IIa study:
      • For treatment of ovarian and endometrial cancer. This is an E39 peptide.
      • Dosage Form: Parenteral
      • Nature of API: Biologic – Protein – Recombinant; Peptide – Chemical
      • Therapeutic Area: Oncology – Immunotherapy
    • GALE-301 + GALE-302 – To complete Phase Ib study:
      • For treatment of ovarian and breast cancer. GALE-302 is an attenuated version of GALE-301, known as E39’.
      • Dosage Form: Parenteral
      • Nature of API: Biologic – Protein – Recombinant; Peptide – Chemical
      • Therapeutic Area: Oncology – Immunotherapy
    • GALE-401 – To complete Phase II study:
      • For treatment of essential thrombocythemia.
      • Dosage Form: Oral
      • Nature of API: Chemical – Normal potency
      • Therapeutic Area: Oncology – Other; Antiplatelet
  • The company contracts with contract research organizations (CROs) to conduct clinical trials.
  • Galena Biopharma does not own or operate manufacturing facilities and relies on third party contract manufacturers for all required raw materials, API and finished product for preclinical studies and clinical trials.
  • Galena Biopharma has no sales, marketing or distribution capabilities or experience.

Business Relationships

  • In January 2014, Galena Biopharma entered into a development and commercialization agreement with Dr. Reddy’s Laboratories for NeuVax. Under the terms of the agreement, Dr. Reddy gained commercial rights in India and gained full responsibility for the Phase II trial of NeuVax for the treatment of gastric cancer. Financial terms were undisclosed.
  • In December 2012, Galena Biopharma and ABIC Marketing Ltd. entered into a licensing and supply agreement for NeuVax for the treatment of breast cancer in Israel. ABIC received exclusive rights to sell and market NeuVax pending FDA or EMA approval. Financial terms were undisclosed.
  • In April 2009, Galena Biopharma and Kwang Dong Pharmaceutical Co. entered into a licensing agreement for NeuVax for the treatment of breast cancer in South Korea. Kwang Dong Pharmaceutical received exclusive rights to sell and market NeuVax pending FDA or EMA approval. Financial terms were undisclosed.1

Drug Product Pipeline

Product Candidate Indication Dosage Form Status Next Anticipated Step
NeuVax Ductal Carcinoma
In Situ
Parenteral Phase I TBA
NeuVax Gastric Cancer Parenteral Phase I TBA
GALE-301 +
GALE-302
Ovarian & Breast Cancer Parenteral Phase Ib TBA
GALE-401 Essential Thrombocythemia Oral Phase II TBA
GALE-301 Ovarian & Endometrial Cancer Parenteral Phase IIa TBA
NeuVax + Herceptin Breast Cancer
(HER 3+)
Parenteral Phase II TBA
NeuVax + Herceptin Breast Cancer
(HER 1+/2+)
Parenteral Phase IIb TBA
NeuVax Breast Cancer Parenteral Phase III TBA

Finances

(In $ thousands) 2015 2014
Revenues
9,734
9,319
R&D Expenditures
23,611
27,674
General & Administrative Expenditures
10,609
16,226
Total Operating Expenses
34,220
43,900

1Galena Biopharma, Inc. 3/05/16 10-K, SEC.gov

Contact Information

Galena Biopharma, Inc. Key Officers
2000 Crow Canyon Place, Suite 380 Mark W. Schwartz, PhD, President & CEO
San Ramon, CA, 94583 USA Bijan Nejadnik, MD, EVP, CMO
Phone: +1-925-498-7700 Gavin Choy, SVP, Clinical Sciences & Operations
Web: www.galenabiopharma.com Patricia Murphy, VP, Regulatory & Compliance

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Scotty is a Research Analyst at PharmSource. He holds a BS degree in Biology from George Mason University and an MPH degree from Eastern Virginia Medical School. He’s experienced in data collection, analysis and management, and has done laboratory analysis and safety program development.

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