Full Press Release Details
Kitov to Acquire Clinical Stage Candidate CM-24 Creating
a Transformational Immuno-Oncology Company
- Transaction adds immune oncology candidate to Kitov's pipeline
which includes promising NT-219 cancer drug resistance prevention therapeutic candidate
- Kitov to receive $3.5M investment from prominent
life science funds Orbimed, Pontifax, and Arkin Holdings, each becoming a principal shareholder
- Kitov plans to initiate Phase I/II study with
TEL AVIV, Israel, March 14, 2019 (GLOBE
NEWSWIRE) -- Kitov Pharma (NASDAQ/TASE: KTOV), an innovative pharmaceutical company, today announced it has signed an agreement
to acquire FameWave Ltd., a privately held biopharmaceutical company developing CM-24, a clinical stage monoclonal antibody targeting
CEACAM1, a novel immune checkpoint. Kitov is planning initiation of a Phase I/II study in early 2020 to evaluate the safety and
efficacy of CM-24 in combination with an anti PD-1 inhibitor. Kitov to host a conference call to discuss the transaction. The scheduling
of the call will be announced separately.
"Combining this transaction
with our proprietary NT219 program, Kitov will become a clinical stage oncology company backed by the support of leading global
life science funds. With the NT219 and CM-24 oncology candidates, we are opening an exciting future for Kitov and I'm looking
forward to building on this momentum. We are very pleased that the investment and support of three leading global life science
funds will enable Kitov to advance our clinical programs and expand our institutional investor base," stated Kitov CEO, Isaac
"The acquisition of CM-24 is
a tremendous opportunity for Kitov and our shareholders. We believe CM-24 has the potential to treat recurrent and advanced stage
cancers including ovarian, colorectal, melanoma, lung, bladder and gastric cancers, and that our Phase I/II trial design could
result in a strong display of the drug's efficacy to the benefit of patients and their families. The journey Kitov started
with Consensi 's FDA approval and our recently announced distribution partnership for Consensi in the US, when
combined with our plans to submit an IND for NT-219 in 2019 and the acquisition of CM-24, transforms Kitov into a robust immune-oncology
development company," Mr. Israel concluded.
Preclinical studies provide strong
justification for CM-24's mechanism of action in activating the immune system through multiple pathways as validated by world
renowned researchers at Harvard Medical School and MIT, in an article published in Nature* as well as by Prof.
Gal Markel from the Tel Hashomer Medical Center**. Additional preclinical studies showed that a combination of CM-24
with a PD-1 antibody resulted in a synergistic anti-cancer effect. Kitov plans to explore higher doses and to test CM-24 in combination
with an anti PD-1 inhibitor. A significant amount of data is available for the existing Investigational New Drug (IND) to support
the continuation of the clinical studies.
FameWave will enter into a
joint clinical collaboration agreement, which is now in an advanced stage of negotiation with a major pharmaceutical company,
for a planned Phase I/II study of CM-24 in combination with a PD-1 antibody in early 2020, with preliminary data expected in late
Acquisition Related Financing
As part of the agreement, three leading
life science focused investment funds, Orbimed, Pontifax, and Arkin Holdings, who collectively hold approximately 90% of FameWave,
will invest $3.5 million in Kitov in exchange for newly issued ADSs of Kitov, priced at $1.23 per ADS. Following this investment
and the FameWave share exchange transaction, Orbimed, Pontifax, and Arkin Holdings will each hold approximately 10% of Kitov's
shares on a fully diluted basis.
Kitov is also currently in discussions
with a number of leading healthcare-focused institutional investors, which have expressed interest in investing in Kitov following
completion of the acquisition.
About the Proposed Transaction
Kitov is acquiring 100% of FameWave
from its shareholders in exchange for $10 million worth of its newly issued ADSs with a long term lock-up period, priced at $1.23
per ADS, plus 50% warrant coverage based on an exercise price of $1.98 per ADS with a 4-year term. In addition, Kitov will provide
a loan to FameWave of up to approximately $2 million to be paid to cCAM BioTherapeutics Ltd., a wholly owned subsidiary of Merck
Sharp and Dohme Corp., known as "MSD" in Israel, which discovered CM-24, or to repay certain loans provided by FameWave's
shareholders. In an initial Phase I dose ranging study of CM24 as single agent, no efficacy signals were detected and the decision
was made to discontinue development, although such decision was not due to any known safety risks. MSD is therefore returning the
rights to CM-24 to former cCAM shareholders and founders of FameWave. Based on a review of the Phase I study results by external
scientific advisors retained by Kitov, coupled with their assessment that CM-24 was found to be generally safe, Kitov plans to
explore higher doses in order to reach receptor saturation, and test CM-24 in combination with an anti PD-1 inhibitor in a well-defined
The transaction has been approved
by the boards of Kitov and FameWave and is expected to close during the third quarter of 2019, subject to: approval of Kitov shareholders;
closing of the transaction for the return of CM-24 to FameWave by MSD; finalization by FameWave of the joint clinical collaboration
agreement; and satisfaction of other customary closing conditions. Should the complete transaction not close, Kitov will be entitled
to repayment of the amounts loaned by Kitov out of amounts actually received by FameWave from commercialization transactions of
CM-24. If no such commercialization transaction is consummated within 36 months from termination, Kitov will be entitled to 20%
of FameWave in return for the approximately $2 million loan which was previously provided. Furthermore, should the transaction
not close due to the failure of FameWave to finalize the clinical collaboration agreement, or the failure of certain other closing
conditions to be fulfilled by the current shareholders of FameWave, then Kitov will be entitled to 100% of FameWave in return for
the approximately $2 million loan which was previously provided.
In connection with the proposed acquisition,
Kitov intends to file relevant materials with the Securities and Exchange Commission, or the SEC, including a proxy statement.
Investors and security holders of Kitov are urged to read these materials when they become available because they will contain
important information about Kitov, FameWave and its shareholders and the proposed acquisition. The proxy statement and other relevant
materials (when they become available), and any other documents filed by Kitov with the SEC, may be obtained free of charge at
the SEC web site at www.sec.gov. Investors and security holders are urged to read the proxy statement and the other relevant materials
when they become available before making any voting decision with respect to the proposed transaction.
This communication does not constitute
an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there
be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration
or qualification under the securities laws of any such jurisdiction. The securities of Kitov will be issued to the selling shareholders
in FameWave, and to the investors in the investment transaction, on a private placement basis pursuant to applicable exemptions
from the prospectus requirements under applicable Israeli securities laws and from the registration requirements of the United
States Securities Act of 1933, as amended (the "U.S. Securities Act"). The securities offered have not been registered
under the U.S. Securities Act or any U.S. state or Israeli securities laws, and may not be offered or sold in the United States
or in Israel, or to, or for the account or benefit of, United States persons or persons in Israel absent registration or any applicable
exemption from the registration and/or prospectus requirements of the U.S. Securities Act and applicable U.S. state and/or Israeli
About CEACAM1 and CM-24
CM-24 is a humanized monoclonal antibody
directed against CEACAM1, an immune checkpoint protein belonging to the Human CEA (Carcino-Embryonic Antigen) protein family. Evidence
has shown that CEACAM1 is expressed on tumor infiltrating lymphocytes and is up-regulated in several cancer types. Preclinical
studies have shown evidence that CM-24 enhances the cytotoxic activity of tumor-infiltrating lymphocytes (TILs) against various
CEACAM1-positive tumor cell lines. CM-24 is being developed for multiple oncological indications according to the expression pattern
of its target protein.
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE:
KTOV) is an innovative pharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov's
veteran team of healthcare and business professionals maintains a proven track record in streamlined end-to-end drug development
and approval. 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. In addition, Kitov's NT219, is a
novel patented small molecule designed to overcome cancer drug resistance that is currently in pre-clinical development. 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.
* Huang Y-H, et al., (2015) Nature,
517(7534): 386-390. doi:10.1038/nature13848