Kitov Pharma Announces Significant Progress in Closing of FameWave Acquisition Deal
16 Agosto 2019 - 9:24AM
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 an amendment to the FameWave acquisition deal was signed.
According to the amendment, the parties agreed that all major
closing conditions have been met other than finalizing the tax
ruling for the sellers and the issuance and exchange of shares in
the companies. Importantly, the amendment facilitates the advance
of activities in the development of the oncology asset CM-24,
including the preparation for a Phase 1/2 clinical trial in
patients with non-small cell lung cancer in collaboration with
Bristol Myers Squibb (BMS). CM-24 is a monoclonal antibody
antagonist of CEACAM1, a novel immune checkpoint that supports
tumor immune evasion and survival through multiple pathways.
The parties also agreed that Orbimed, Pontifax
and Arkin Holdings will deposit in escrow their aggregate $3.5
million investment in Kitov priced at $1.23 per share until the tax
ruling is received and the shares are issued and transferred.
"Moving towards finalizing the acquisition of
FameWave is an important milestone in Kitov shift towards an
oncology focused company. It allows us to advance the clinical
development of CM-24 in parallel to advancing our second oncology
product NT-219 into clinical trials," said Isaac Israel, chief
executive officer of Kitov. "We look forward to initiating the
planned Phase 1/2 trial in collaboration with BMS to evaluate the
combination of CM-24 with BMS’s PD-1 inhibitor Opdivo® in patients
with non-small cell lung cancer. CM-24 has the potential to be an
effective therapy for cancer patients and we are excited to advance
this drug candidate into the clinic soon and provide patients with
a long-lasting treatment alternative."
In connection with the progress made toward
closing of the acquisition, FameWave has entered into a
manufacturing agreement for CM-24 to facilitate the initiation of
the Phase 1/2 trial and to advance R&D activities in
preparation for the study.
About Kitov Pharma
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE:
KTOV) is a clinical-stage company advancing first-in-class
therapies to overcome tumor immune evasion and drug resistance, to
create successful long-lasting treatments for people with cancer.
Kitov’s oncology pipeline includes NT-219, a small molecule
targeting the novel cancer drug resistance pathways IRS1/2 and
STAT3. Kitov is currently advancing NT-219 in combination with
cetuximab as a third-line or second-line treatment option for the
treatment of recurrent and metastatic squamous cell carcinoma of
head & neck cancer (SCCHN). Kitov is also under contract to
acquire 100% of FameWave Ltd. which owns CM-24, a monoclonal
antibody blocking CEACAM1, a novel immune checkpoint that supports
tumor immune evasion and survival through multiple pathways. Kitov
will advance CM-24 as a combination therapy with anti-PD1
checkpoint inhibitors in a clinical collaboration agreement with
Bristol Myers Squibb (NYSE:BMY) in a planned Phase 1/2 clinical
trials to evaluate the combination of CM-24 with the PD-1 inhibitor
nivolumab (Opdivo®) for the treatment of non-small cell lung cancer
(NSCLC) All major closing conditions have been met other than
finalizing the tax ruling for the sellers and the issuance and
exchange of shares in the companies and the acquisition is expected
to close during the third quarter of 2019. Consensi, a
fixed-dose combination of celecoxib and amlodipine besylate, for
the simultaneous treatment of osteoarthritis pain and hypertension
was approved by the FDA for marketing in the U.S in May 2018 and is
expected to be launched in the U.S. at the end of 2019 by its
partner Coeptis Pharmaceuticals. Kitov has also partnered to
commercialize Consensi in China and South Korea.
The company is headquartered in Tel Aviv,
Israel. For more information, 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;
the 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
Kitov Pharma (NASDAQ:KTOV)
Gráfico Histórico do Ativo
De Ago 2024 até Set 2024
Kitov Pharma (NASDAQ:KTOV)
Gráfico Histórico do Ativo
De Set 2023 até Set 2024