BRISBANE, Calif., May 30, 2017 (GLOBE NEWSWIRE) -- KaloBios Pharmaceuticals, Inc. (OTC:KBIO), a biopharmaceutical company focused on advancing
medicines for patients with neglected and rare diseases, today announced it has submitted an Investigational New Drug (IND)
application to the U.S. Food and Drug Administration (FDA) for benznidazole for the treatment of Chagas disease, a neglected
tropical disease.
The IND application is a critical part of the Company’s previously outlined plan to advance benznidazole for potential U.S.
approval for Chagas disease.
“Our team continues to deliver on key milestones, progressing benznidazole on an accelerated timeline to an expected filing of a
New Drug Application in the first quarter of 2018,” said Cameron Durrant, MD, chairman and CEO of KaloBios. “This work addresses
enduring unmet need. People infected with Chagas disease carry a dramatic and significant increased risk of death. According to a
recent PLOS Neglected Tropical Diseases paper, those infected have an almost 18 times higher risk of
death from Chagas-related cardiac issues than those not infected.”
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").
According to the Centers for Disease Control and Prevention (CDC), an estimated 300,000 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. 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.
About KaloBios Pharmaceuticals, Inc.
KaloBios Pharmaceuticals, Inc. (OTC:KBIO) is an emerging biopharmaceutical company focused on advancing medicines for patients
with neglected and rare diseases through innovative and responsible business models. Lead compounds in the KaloBios 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 potentially juvenile myelomonocytic leukemia (JMML). For more information, visit www.kalobios.com.
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. 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" 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
