SOUTH SAN FRANCISCO, Calif.,
Nov. 19, 2015 /PRNewswire/
-- KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO), today
announced that an investor group led by Martin Shkreli, the Founder and Chief Executive
Officer of Turing Pharmaceuticals AG, has acquired 70% of its
outstanding shares. KaloBios also announced the appointment of
Martin Shkreli to the position of
Chief Executive Officer and his election as Chairman of the
Board. In his new role, Mr. Shkreli will work with the
company's senior management team to ensure the Company's continued
operations. KaloBios further announced that David Moradi, Tony
Chase and Marek Biestek have
been elected to the Board of Directors. In connection with these
developments, the former directors have resigned, effective
immediately.
KaloBios has received a commitment from Mr. Shkreli and other
investors for an equity investment of at least $3.0 million. In addition, Mr. Shkreli and the
group of investors have committed to a $10
million equity financing facility, subject to applicable
shareholder approval.
Martin Shkreli, Chief Executive
Officer, said, "We believe that the KaloBios' lenzilumab is a very
promising candidate for the treatment of various rare and orphan
diseases. This monoclonal antibody neutralizes soluble
granulocyte-macrophage colony stimulating factor (GM-CSF), a
central actor in leukocyte differentiation, autoimmunity and
inflammation. Lenzilumab has particular promise in Chronic
Myelomonocytic Leukemia (CMML), a disease with no FDA-approved
treatment options and a 3-year overall survival rate of 20%."
An IND for a Phase I/II CMML monotherapy study of lenzilumab has
been cleared by the Food and Drug Administration (NCT02546284).
Preclinical studies have shown lenzilumab can be used to cause
apoptosis in CMML cells by depriving them of GM-CSF. Lenzilumab may
also have clinical utility in other rare autoimmune and
inflammatory disorders. A 31-patient Phase I/II clinical trial
of lenzilumab will begin enrollment at eight leading oncology
clinical trial sites by year end 2015 with interim results possible
as soon as the first half of 2016.
The company has approximately $5
million in cash and will endeavor to file its quarterly
results on Form 10-Q as soon as possible. Mr. Shkreli will continue
as Chief Executive Officer of Turing Pharmaceuticals AG and the two
companies will operate independently.
About KaloBios
KaloBios Pharmaceuticals, Inc. is seeking to improve the lives
of patients by developing innovative therapies to treat diseases of
high unmet medical need, with a current focus on oncology. KaloBios
has focused on advancing lenzilumab, an anti-GM-CSF mAb that
KaloBios is evaluating in oncology indications where GM-CSF may
play a key role, such as chronic myelomonocytic leukemia (CMML).
The IND for lenzilumab in CMML, an orphan oncology indication, has
been cleared by the FDA.
For more information on KaloBios Pharmaceuticals, please visit
our web site at http://www.kalobios.com.
Forward-Looking Statements
This release contains forward-looking statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, and statements regarding the
company's clinical development of lenzilumab. 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 results could differ materially from those contained in the
forward-looking statements. Forward-looking statements are subject
to a number of risks and uncertainties including, but not limited
to, the company's limited cash reserves and its ability to obtain
additional capital on acceptable terms, or at all, including the
additional capital which will be necessary to complete the clinical
trials that the company has initiated or plans to initiate; the
potential timing and outcomes of clinical studies of lenzilumab
undertaken now or in the future; the ability of the company to
timely source adequate supply of its development products from
third party manufacturers on whom the company depends; the
potential, if any, for future development of any of its present or
future products; the company's ability to successfully progress,
partner or complete further development of its programs; the
uncertainties inherent in clinical testing; the timing, cost and
uncertainty of obtaining regulatory approvals; the company's
ability to protect the company's intellectual property;
competition; changes in the regulatory landscape or the imposition
of regulations that affect the company's products; and other
factors listed under "Risk Factors" in the company's most recent
quarterly report on Form 10-Q filed with the Securities and
Exchange Commission on August 10,
2015, the Annual Report on Form 10-K filed on March 16, 2015, and the company's other filings
with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in
their entirety by this cautionary notice. You are cautioned not to
place undue reliance on any forward-looking statements, which speak
only as of the date of this release. The company has no obligation,
and expressly disclaims any obligation to update, revise or correct
any of the forward-looking statements, whether as a result of new
information, future events or otherwise.
For more information, visit http://www.kalobios.com.
Contact:
Martin Shkreli
KaloBios CEO
1-646-356-5590
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SOURCE KaloBios Pharmaceuticals, Inc.