Full Press Release Details
Enforcement Agreement Finalized between Kitov Pharma
and the Israeli Securities Authority
Investigation of Kitov and certain officers has been terminated
AVIV, Israel, August 14, 2019 - 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.
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."
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.
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.
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
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.
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.
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.
Statements and Kitov's Safe Harbor Statement
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,
Deputy CEO & Chief Financial Officer
+972-3-933-3121 ext. #105