- Executive Chairman to Continue to Fulfill Interim CEO
Duties as Board Commences Executive Search
- Data Correction for Fifth Patient in Phase 2 PNH Trial for
Coversin
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was withdrawn from the trial at day 43 due to a suspected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
<LLQ (day 1) but clinical response fluctuated and did not
stabilize. After withdrawal, the patient switched to eculizumab. On
eculizumab, LDH decreased to below 1.5X ULN and the patient
experienced other clinical complications.” The Company has found
that the fifth patient, who was withdrawn from the trial at day 43
due to a suspected co-morbidity unrelated to treatment, did not
meet the primary endpoint.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170530006401/en/
Investors:The Trout GroupLee Stern,
646–378–2922lstern@troutgroup.comorMedia:DGI CommSusan Forman /
Laura Radocaj, 212-825-3210
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