Transforming company with focus and commitment on neglected and rare diseases
Continue to expect New Drug Application (NDA) submission for benznidazole in Chagas disease to FDA in first
quarter 2018
BRISBANE, Calif., July 27, 2017 (GLOBE NEWSWIRE) -- KaloBios Pharmaceuticals, Inc. (OTCQB:KBIO), a biopharmaceutical company focused on advancing
medicines for patients with neglected and rare diseases, today announced it will change the company’s name to Humanigen, Inc.,
effective August 7, 2017.
“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.
About the Company
The company is a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases through
innovative, accelerated business models. Lead compounds in the portfolio are benznidazole for the potential treatment of Chagas
disease in the U.S., and the proprietary monoclonal antibodies, lenzilumab and ifabotuzumab. Lenzilumab has potential for treatment
of various rare diseases, including hematologic cancers such as chronic myelomonocytic leukemia (CMML) and juvenile myelomonocytic
leukemia (JMML).
About Benznidazole
Benznidazole is an oral anti-parasitic medication used in the treatment of Chagas disease, caused by a protozoan
parasite Trypanosoma cruzi carried and transmitted by triatomine insects (often called "kissing bugs"). An
estimated 350,000 people in the United States are infected with Chagas disease, which, if left untreated, can lead to
serious and potentially life-threatening cardiovascular, gastro-intestinal and neurological complications. According to a May 2017
PLOS Neglected Tropical Diseases paper, those infected have an almost 18 times average higher risk of death from
Chagas-related cardiac issues than those not infected. Benznidazole is the current preferred treatment for Chagas disease in other
parts of the world but is not currently approved by the FDA in the U.S.
Forward-Looking Statements
This release contains forward-looking statements that are intended to be subject to protection afforded by the safe harbor
for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Forward-looking statements
reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although
management believes that the expectations reflected in such statements are reasonable, they give no assurance that such
expectations will prove to be correct and you should be aware that actual events or results may differ materially from those
contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals,"
"accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements
regarding our expectations as to the timing for submission of our NDA for benznidazole and our expectations for executing
on the other key priorities and anticipated milestones described above. Forward-looking statements are subject to a number of risks
and uncertainties including, but not limited to, our lack of profitability and the need for additional capital to operate our
business as a going concern; the uncertainties inherent in the development and launch of any new pharmaceutical product; the
acceptability to FDA of a 505(b)(2) development pathway for approval of benznidazole using data drawn from previously conducted
studies; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic
and other filings with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place
undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to
revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof
or to reflect new information or the occurrence of unanticipated events, except as required by law.
CONTACT: Investors: Mike Cole O: 949-259-4988 C: 949-444-1341 mike.cole@mzgroup.us Media: Lisa Guiterman O: 301-217-9353 C: 202-330-3431 media@kalobios.com www.kalobios.com
