Kitov Pharma Ltd. (“Kitov”) (NASDAQ/TASE: KTOV), a
clinical-stage company advancing first-in-class therapies to
overcome tumor immune evasion and drug resistance, today announced
that a settlement agreement with the Israel Securities Authority
(ISA) was approved, resulting in the termination of ISA’s
investigation against Kitov concerning historical disclosures and
levying a fine on the Company and certain principals.
“After three long years of investigation, the ISA Enforcement
Committee approved a settlement agreement which reflects our
original position indicating that this was an unintentional error
that did not cause any substantive damage to our investors” said
Isaac Israel, chief executive officer of Kitov. “We thank the ISA
Enforcement Committee for taking this decision to accept the
settlement agreement. We will now focus all efforts on advancing
our therapeutics and clinical candidates to the benefit of patients
and our investors.”
The investigation arose in connection with Kitov's Phase 3
clinical trial for Consensi™ as part of its development program.
Although not required by the U.S. Food and Drug Administration
(FDA), on a voluntary basis Kitov planned to have the results from
the Phase 3 study be reviewed by an impartial committee in order to
decide if additional patient recruitment was required to complete
the study. An unintentional error was made by a service provider,
which resulted in one of the voluntary committee members receiving
and examining the results later than as instructed by the Company.
The result was that the voluntary committee did not convene as
planned, and not as previously reported by the Company. Due to the
positive and statistically significant results of the study, the
Company released the results and ended the study.
The ISA allegations as described in the settlement agreement
were not related to the validity of the results of the Phase 3
clinical trial data of Consensi™, which met its primary efficacy
endpoint with high statistical significance and was accepted and
approved by the FDA. In addition, none of these allegations are
related to any U.S. securities laws or regulations. Moreover,
the ISA Enforcement Committee stated in its ruling that the
allegations caused no substantive damage to the Company’s
shareholders.
As described in the settlement agreement, there was an
unintentional error to fail to report that the committee had not
convened. It was also further noted in the settlement agreement
that the definition of the impartiality of one of the committee
members was not properly described in the Company's filings in
Israel, which could have resulted in a misunderstanding for
investors. The ISA is levying a fine on the Company in an amount of
approximately $430,000 in addition to a total of $110,000 in fines
on its chief executive officer Isaac Israel, its former chairman of
the board Dr. Paul Waymackand its former chief financial officer
Simcha Rock.
For more details and information on the settlement agreement,
including a copy of the full agreement please see the Report of
Foreign Issuer on Form 6-K submitted by Kitov to the SEC on August
13, 2019.
About Kitov Pharma
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE:
KTOV) is advancing first-in-class oncology therapies to overcome
tumor drug resistance, increase treatment response rate, and slow
tumor progression. Kitov’s oncology pipeline includes NT219 a small
molecule targeting novel cancer drug resistance pathways and Kitov
is under contract to acquire 100% of FameWave Ltd. which owns
CM-24, a humanized monoclonal antibody directed against
carcinoembryonic antigen-related cell adhesion molecule 1
(CEACAM1), an immune checkpoint protein belonging to the Human CEA
(Carcino-Embryonic Antigen) protein family. CM-24 is being
developed for multiple oncological indications according to the
expression pattern of its target protein. Following the recent
receipt of the approval of Kitov’s shareholders for the acquisition
of FameWave, and the finalization of a clinical collaboration
agreement between FameWave and Bristol Myers Squibb (NYSE:BMY) for
their planned Phase 1/2 clinical trials to evaluate the combination
of CM-24 with nivolumab (Opdivo®), a PD-1 inhibitor, the
acquisition is expected to close during the third quarter of 2019,
subject to fulfillment of certain additional closing conditions. In
addition, Kitov’s combination drug, Consensi™, treating
osteoarthritis pain and hypertension simultaneously, was approved
by the FDA for marketing in the U.S and is partnered in the U.S,
China and South Korea.
By lowering development risk and cost through
fast-track regulatory approval of novel late-stage therapeutics,
Kitov plans to deliver rapid ROI and long-term potential to
investors, while making a meaningful impact on people’s lives. For
more information on Kitov, the content of which is not part of this
press release, please visit http://www.kitovpharma.com.
Forward-Looking Statements and Kitov's
Safe Harbor Statement
Certain statements in this press release that are
forward-looking and not statements of historical fact are
forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements include, but are not limited to,
statements that are not statements of historical fact, and may be
identified by words such as “believe”, “expect”, “intend”, “plan”,
“may”, “should”, “could”, “might”, “seek”, “target”, “will”,
“project”, “forecast”, “continue” or “anticipate” or their
negatives or variations of these words or other comparable words or
by the fact that these statements do not relate strictly to
historical matters. You should not place undue reliance on these
forward-looking statements, which are not guarantees of future
performance. Forward-looking statements reflect our current views,
expectations, beliefs or intentions with respect to future events,
and are subject to a number of assumptions, involve known and
unknown risks, many of which are beyond our control, as well as
uncertainties and other factors that may cause our actual results,
performance or achievements to be significantly different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Important factors that could cause
or contribute to such differences include, among others, risks
relating to: the manner in which the parties to the transaction for
the acquisition of FameWave by Kitov plan to effect the
transaction; the expected benefits, synergies and costs of the
transaction; management plans relating to the transaction; the
expected timing of the completion of the transaction; the parties’
ability to complete the transaction considering the various closing
conditions; the plans, strategies and objectives of management for
future operations; product development for NT219 and CM-24; the
potential future financial impact of the transaction; and any
assumptions underlying any of the foregoing; the process by which
early stage products such as CM-24 could potentially lead to
an approved product is long and subject to highly significant
risks, particularly with respect to a joint development
collaboration; the fact that drug development and commercialization
involves a lengthy and expensive process with uncertain outcomes;
our ability to successfully develop and commercialize our
pharmaceutical products; the expense, length, progress and results
of any clinical trials; the lack of sufficient funding to finance
the clinical trials; the impact of any changes in regulation and
legislation that could affect the pharmaceutical industry; the
difficulty in receiving the regulatory approvals necessary in order
to commercialize our products; the difficulty of predicting actions
of the U.S. Food and Drug Administration or any other applicable
regulator of pharmaceutical products; the regulatory environment
and changes in the health policies and regimes in the countries in
which we operate; the uncertainty surrounding the actual market
reception to our pharmaceutical products once cleared for marketing
in a particular market; the introduction of competing products;
patents attained by competitors; dependence on the effectiveness of
our patents and other protections for innovative products; our
ability to obtain, maintain and defend issued patents with
protective claims; the commencement of any patent interference or
infringement action; our ability to prevail, obtain a favorable
decision or recover damages in any such action; and the exposure to
litigation, including patent litigation, and/or regulatory actions;
any continued uncertainty surrounding an investigation by the
Israel Securities Authority into our historical public disclosures
which was settled under an administrative enforcement proceeding,
and the potential impact of such investigation and settlement on
the trading of our securities or on our clinical, commercial and
other business relationships, or on receiving the regulatory
approvals necessary in order to commercialize our products, and
other factors that are discussed in our in our Annual Report on
Form 20-F for the year ended December 31, 2018 and in our other
filings with the SEC, including our cautionary discussion of risks
and uncertainties under ‘Risk Factors’ in our Registration
Statements and Annual Reports. These are factors that we believe
could cause our actual results to differ materially from expected
results. Other factors besides those we have listed could also
adversely affect us. Any forward-looking statement in this press
release speaks only as of the date which it is made. We disclaim
any intention or obligation to publicly update or revise any
forward-looking statement, or other information contained herein,
whether as a result of new information, future events or otherwise,
except as required by applicable law. You are advised, however, to
consult any additional disclosures we make in our reports to the
SEC, which are available on the SEC’s website,
http://www.sec.govFor further information, contact: Gil
Efron Deputy CEO & Chief Financial Officer
+972-3-933-3121 ext. #105 IR@kitovpharma.com
Media Inquiries:Darren Opland,
Ph.D.darren@lifescipublicrelations.com+1 646 627 8387
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