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Galena Biopharma, Inc. (NASDAQ:GALE)

Mission Statement: To develop innovative, targeted oncology treatments to address major unmet medical needs and advance cancer care.

Galena Biopharma is focused on developing and commercializing targeted oncology treatments to address major unmet medical needs and advance cancer care. The company’s peptide vaccine immunotherapies harness the patient’s own immune system to identify and destroy cancer cells. Utilizing peptide immunogens has many clinical advantages, including an excellent safety profile and long-lasting protection through immune system activation and convenient delivery.

Abstral® is Galena’s FDA-approved therapy for breakthrough cancer pain in opioid-tolerant cancer patients. It is estimated that at least 40% of cancer patients experience breakthrough pain episodes multiple times per day, each with a median duration of 30 minutes. The innovative Abstral formulation rapidly dissolves under the tongue in seconds, provides rapid relief of breakthrough pain in minutes, and matches the duration of the entire pain episode.

NeuVax™, currently in a Phase III trial, has been developed to bolster the immune response in breast cancer patients. The trial, entitled PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment), is being conducted under an FDA-approved Special Protocol Assessment (SPA). The therapy targets the 50% to 60% of patients with tumors that express HER2 in low-to-intermediate amounts and achieve remission with current standard of care, but who have no available HER2 targeted adjuvant treatment options to maintain their disease-free status. NeuVax can be used to help the body target and kill undetected cancer cells before they grow into metastatic tumors.

The company’s second product candidate, Folate Binding Protein (FBP), is a highly immunogenic peptide that can stimulate the immune system to recognize and destroy preclinical FBP-expressing cancer cells. FBP is over-expressed in more than 90% of ovarian and endometrial cancers, as well as 20%-50% of breast, lung, colorectal, and renal cell carcinomas. This vaccine is currently in a Phase 1/2 trial in two gynecological cancers: ovarian and endometrial adenocarcinomas.

Galena’s experienced management team has an excellent track record in clinical development, commercial operations, and successful partnership execution. Enhanced by multiple development and commercial collaborations, the company’s suite of immunotherapeutic solutions is poised to capitalize on the vast opportunities in today’s healthcare industry.

Note: Abstral carries a Black Box warning. Please refer to the full Prescribing Information for further information.

Key Investment Highlights

  • FDA-Approved Product to Treat Breakthrough Cancer Pain
  • Phase III PRESENT trial ongoing under FDA-approved SPA
  • Pipeline of Targeted Immunotherapies Addressing Major Markets
  • Strong Analyst Support with Median Price Target of $5.50
  • The Therapeutic Cancer Vaccine Market is Doubling in Size Each Year
 
Galena Biopharma (NASDAQ:GALE)
 
Management Team

Mark J. Ahn, Ph.D
President & Chief Executive Officer

Rosemary Mazanet, M.D., Ph.D.
Executive Vice President
& Chief Medical Officer

Mark W. Schwartz, Ph.D.
Executive Vice President
& Chief Operating Officer

Hana B. Moran, Ph.D.
Vice President, Regulatory & Compliance

Lynn Sutton, RN, MN, NP
Vice President, Clinical Operations

Christopher Lento
Vice President, Sales
& Commercial Operations

Ryan Dunlap
Director, Controller & Principal
Accounting Officer

 

 

 

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