NEW YORK & LONDON--(BUSINESS WIRE)--
Akari Therapeutics (NASDAQ:AKTX), an emerging growth, clinical-stage biopharmaceutical company, today announced the resignation of Gur Roshwalb, the Company’s Chief Executive Officer, and correction to fifth patient data in the Company’s press release issued on April 24, 2017 (the “Release”).
As previously reported by the Company, its Board of Directors established an ad hoc special committee of the Board to review the involvement, if any, of Company personnel with the report issued by Edison Investment Research Ltd. (“Edison”) on April 26, 2017 titled “Akari’s Coversin matches Soliris in Phase II” (the “Edison Report”), which was later retracted. Edison was retained by the Company to produce research reports about the Company. While that review was pending, Dr. Gur Roshwalb, the Company’s Chief Executive Officer, was placed on administrative leave and Dr. Ray Prudo in his role as Executive Chairman temporarily assumed Dr. Roshwalb’s duties in his absence.
Following that review, the Company determined that the Edison Report was reviewed and approved by Dr. Roshwalb, in contravention of Company policy. On May 29, 2017, Dr. Roshwalb submitted his resignation as Chief Executive Officer and member of the Company’s Board of Directors, effective immediately. The Company has commenced an executive search to identify a replacement Chief Executive Officer and in the interim, Dr. Ray Prudo will continue to act as the Company’s Chief Executive Officer.
In addition, the Company has determined following that review that the
previously reported interim analysis of the Company’s ongoing Phase 2
PNH trial of Coversin (the “Interim Phase 2 Results”), as stated in the
Release, was inaccurate with respect to one of five patients for whom
information was provided in the Release. The Release stated that the
“fifth patient with an LDH of 3.7 X ULN at baseline achieved the primary
endpoint at day 14, but was withdrawn from the trial at day 43 due to a
suspected co-morbidity unrelated to treatment, which would have excluded
the patient from the trial protocol. While on Coversin, the patient met
the primary endpoint (day 14), and achieved and maintained a CH50
The Company expects to release additional results with respect to the
four continuing patients in the Phase 2 PNH trial of Coversin in
approximately four weeks.
The Company and individuals it may be required to indemnify may be
subject to governmental investigations and proceedings in connection
with the Edison Report and the Release. On May 12, 2017, a putative
class action captioned Derek Da Ponte v. Akari Therapeutics,
PLC, Gur Roshwalb, and Dov Elefant (Case 1:17-cv-03577) was
filed in the U.S. District Court for the Southern District of New York
against the Company, the Company’s Chief Executive Officer and the
Company’s Chief Financial Officer. In addition, on May 19, 2017, a
putative class action captioned Sherli Shamoon v. Akari
Therapeutics, PLC, Gur Roshwalb, and Dov Elefant (Case
1:17-cv-03783) was filed in the U.S. District Court for the Southern
District of New York against the Company, the Company’s Chief Executive
Officer and the Company’s Chief Financial Officer. The plaintiffs in
both class actions asserted claims alleging federal securities laws
violations relating primarily to the Company’s press release issued on
April 27, 2017 stating that investors should not rely on the Edison
Report. The purported class covers the period from March 30, 2017 to May
11, 2017. The actions seek unspecified damages and costs and fees. At
present, no summons has been served on the Company in either action. If
served, the Company intends to vigorously defend itself against these
lawsuits. The Company is unable at this time to predict the timing or
outcome of those or any other lawsuits that may be commenced in relation
to the matters discussed herein or otherwise. Nor is the Company able to
predict whether any governmental authorities will institute
investigations or proceedings in relation to these matters, or the
impact, if any, of any of the foregoing on the Company’s business,
operations, cash flows and/or financial condition. The Company
voluntarily reported the special committee’s investigation to the
Securities and Exchange Commission.
About Akari Therapeutics Plc
Akari is a clinical-stage biopharmaceutical company focused on the
development and commercialization of life-transforming treatments for a
range of rare and orphan autoimmune and inflammatory diseases caused by
dysregulation of complement C5 and Leukotriene B4 (LTB4), including
paroxysmal nocturnal hemoglobinuria (“PNH”), atypical Hemolytic Uremic
Syndrome (“aHUS”), and Guillain Barré syndrome (“GBS”). Akari’s lead
product candidate, Coversin™ complement inhibitor, a second-generation
complement inhibitor, acts on complement component-C5, preventing the
release of C5a and the formation of C5b–9 (also known as the membrane
attack complex or MAC), and independently also inhibits LTB4 activity.
C5 inhibition is growing in importance in a range of rare autoimmune
diseases related to dysregulation of the complement component of the
immune system, including PNH, aHUS, and GBS. Exploiting the power of
nature, Akari is also developing other tick derived proteins and expects
to bring additional compounds to clinical trials over the next several
years. The pipeline is focused on developing bioengineered versions of
native tick salivary proteins that act as anti-inflammatory compounds
allowing the tick to remain on its host. These compounds include PGP
sparing LTB4 inhibitors, classical and alternative complement
inhibitors, anti-histamines, and serotonin inhibitors as examples. Akari
is also developing engineered forms that allow for potential oral
absorption, as, for example, a potential orally absorbed C5 inhibitor,
and tissue specific proteins, as, for example, Coversin™ that acts
specifically at the neuromuscular junction for diseases like myasthenia
gravis.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release constitute “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements reflect our current
views about our plans, intentions, expectations, strategies and
prospects, which are based on the information currently available to us
and on assumptions we have made. Although we believe that our plans,
intentions, expectations, strategies and prospects as reflected in or
suggested by those forward-looking statements are reasonable, we can
give no assurance that the plans, intentions, expectations or strategies
will be attained or achieved. Furthermore, actual results may differ
materially from those described in the forward-looking statements and
will be affected by a variety of risks and factors that are beyond our
control. Such risks and uncertainties for our company include, but are
not limited to: needs for additional capital to fund our operations, an
inability or delay in obtaining required regulatory approvals for
Coversin and any other product candidates, which may result in
unexpected cost expenditures; risks inherent in drug development in
general; uncertainties in obtaining successful clinical results for
Coversin and any other product candidates and unexpected costs that may
result therefrom; failure to realize any value of Coversin and any other
product candidates developed and being developed in light of inherent
risks and difficulties involved in successfully bringing product
candidates to market; inability to develop new product candidates and
support existing product candidates; the approval by the FDA and EMA and
any other similar foreign regulatory authorities of other competing or
superior products brought to market; risks resulting from unforeseen
side effects; risk that the market for Coversin may not be as large as
expected; inability to obtain, maintain and enforce patents and other
intellectual property rights or the unexpected costs associated with
such enforcement or litigation; inability to obtain and maintain
commercial manufacturing arrangements with third party manufacturers or
establish commercial scale manufacturing capabilities; the inability to
timely source adequate supply of our active pharmaceutical ingredients
from third party manufacturers on whom the company depends; our
inability to obtain additional capital on acceptable terms, or at all;
unexpected cost increases and pricing pressures; uncertainties of cash
flows and inability to meet working capital needs; and risks and other
risk factors detailed in our public filings with the U.S. Securities and
Exchange Commission, including our Annual Report on Form 20-F filed on
March 31, 2017. Except as otherwise noted, these forward-looking
statements speak only as of the date of this press release and we
undertake no obligation to update or revise any of these statements to
reflect events or circumstances occurring after this press release. We
caution investors not to place considerable reliance on the
forward-looking statements contained in this press release.
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