On April 27, 2017 KaloBios Pharmaceuticals, Inc. (OTCQB:KBIO), a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, reported it will change the company’s name to Humanigen, Inc., effective August 7, 2017 (Press release, KaloBios, APR 27, 2017, View Source [SID1234525361]).
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"We have completely transformed into a new company with a focus on neglected and rare disease. Our new identity reflects the company we have re-built with a new team consistently executing our strategy in diseases with high unmet need and leading the way in how we operate," said Cameron Durrant, MD, chairman and CEO. "Moving forward as Humanigen will give us a new platform to continue our significant progress, to focus on the future, and to deliver value for patients, investors and all our other stakeholders."
As Humanigen, the company expects to accelerate this transformation executing on key priorities and anticipated milestones, including:
New Drug Application (NDA) submission for benznidazole in Chagas disease, a neglected tropical disease, to the U.S. Food and Drug Administration (FDA) in first quarter 2018
Submission for both rare pediatric designation and orphan drug designation for lenzilumab in Juvenile Myelomonocytic Leukemia (JMML)
Development of an interim analysis of the lenzilumab Phase 1 trial in Chronic Myelomonocytic Leukemia (CMML)
Up-listing to a national securities exchange and ongoing work to improve the capital structure
In just over a year, the company has transformed how it operates and has rapidly achieved a number of important clinical development milestones, including:
Benznidazole in Chagas disease:
Confirmed that benznidazole is eligible for review via the 505(b)(2) regulatory pathway as a potential treatment for Chagas disease per FDA-issued guidance
Eligible to receive priority review voucher if benznidazole becomes the first FDA-approved treatment for Chagas disease per agency guidance
Opened a benznidazole Investigational New Drug (IND) application with the FDA
Received FDA orphan drug designation for benznidazole
Lenzilumab in CMML:
Initiated a Phase 1 trial of lenzilumab in CMML, a rare disease with unmet need
The company’s stock will also begin trading under the new ticker symbol HGEN on the OTCQB market as of the opening on August 7, 2017 – the effective date. The CUSIP number for Humanigen’s common stock will be 444863104.
The name change does not affect the rights of the company’s stockholders. No action is required by existing stockholders with respect to the name change, and certificates representing outstanding shares of the company’s common stock will not need to be exchanged.
Upon effective date, the company’s website will be www.humanigen.com.