Recent Updates
Recently added Catalysts
PPBT

Kitov Pharma Provides Corporate Update and Reports First Half 2020 Financial Results

Key Takeaway: Kitov Pharma Provides Corporate Update and Reports First Half 2020 Financial Results TEL AVIV, Israel, August 11, 2020 -- Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug res

Full Press Release Details

Kitov Pharma Provides Corporate Update
and Reports First Half 2020 Financial Results
TEL AVIV, Israel, August 11, 2020 -- 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 provided a corporate update and announced financial results for the six months ended June 30,
"The first half of 2020 represented a transformative period
for Kitov, with multiple commercial, clinical and corporate milestones achieved," said Isaac Israel, Chief Executive Officer.
"Importantly, we have successfully completed our evolution to an oncology-focused biotechnology
company with the acquisition of CM24, an inhibitor of CEACAM1, and our strong cash balance at the end of the first half of the
year of over $60 million positions us well to continue building a pipeline of attractive oncology assets. Moreover, our emerging
oncology pipeline continued to advance expeditiously in the first half of the year and we expect to achieve multiple key upcoming
"For CM24, we presented
positive Phase 1 results at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program indicating that CM24
at higher doses warrants further evaluation in a larger clinical study, and we look forward to the anticipated initiation of our
Phase 1/2 clinical trial to evaluate the combination of CM24 with nivolumab (OPDIVO ), to be conducted in collaboration with
Bristol Myers Squibb Company (BMS), in the second half of this year," continued Mr. Israel. "We were excited to receive
U.S. Food and Drug Administration (FDA) acceptance of our Investigational New Drug (IND) application to conduct the Phase 1/2 clinical
trial that will evaluate NT219 as a monotherapy treatment for advanced solid tumors and in combination with cetuximab for the treatment
of recurrent or metastatic solid tumors and head and neck cancer or colorectal adenocarcinoma."
achieved a significant milestone in May 2020 with the U.S. commercial launch of CONSENSI , a fixed-dose combination of celecoxib
and amlodipine besylate, designed for the simultaneous treatment of hypertension and osteoarthritis pain. We believe that our strong
balance sheet of $63 million in cash at the end of the first half of 2020, which provides us runway beyond 2024, furnishes us with
the financial support for our continued development efforts aimed at further advancing CM24 and NT219, and allows us the flexibility
to enhance our growth through potential acquisitions and/or in-licensing activity in our core focus area of oncology," concluded
Recent Corporate Highlights
antibody targeting CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways:
NT219: a dual inhibitor,
novel small molecule targeting IRS1/2 and STAT3, important oncogenic drivers and major drug resistance pathways in many hard-to-treat
CONSENSI : a fixed-dose combination of celecoxib
and amlodipine besylate, designed for the simultaneous treatment of hypertension and osteoarthritis pain:
Financing Activities
Financial Results for the Six Months Ended June 30, 2020
Total revenues for the six months ended June 30, 2020, were
$1.0 million, the same as compared to the same period of 2019. The revenue for the six months ended June 30, 2020, included a milestone
payment related to the CONSENSI launch from Coeptis Pharmaceuticals.
Research & Development (R&D) Expenses
R&D expenses for the six months ended June 30, 2020, were
$3.1 million, an increase of $1.4 million, or 85.6%, compared to $1.7 million in the same period of 2019. The increase was due
to preparations related to the anticipated initiation of the CM24 and NT219 clinical trials.
Selling, General & Administrative (SG&A) Expenses
SG&A expenses for the six months ended June 30, 2020, were
$2.2 million, compared to $3.3 million in the same period of 2019. The decrease was due to a decrease in professional and legal
fees, user fees to the FDA and a one-time settlement fee in the first half of 2019.
Operating loss for the six months ended June 30, 2020, was $4.3
million, an increase of $0.6 million, or 20.7%, compared to $3.6 million in the same period of 2019.
On a non-IFRS basis (as
reconciled below), adjusted operating loss for the six months ended June 30, 2020,
was $3.5 million, an increase of $0.5 million from $3.1 million for the six months ended June 30, 2019.
Net loss for the six months ended June 30, 2020, was $27.8 million,
or $0.46 per basic and diluted share, compared to a net loss of $2.6 million, or $0.14 per basic and diluted share, in the comparable
period of 2019. The increase was due to an increase in expenses related to warrants in the amount of $24.6 million. Adjusted net
loss for the first half of 2020 was $3.5 million, compared to $3.1 million in the same period of 2019. The increase of $0.4 million
was due to an increase in R&D expenses related to the Company's preparations for the planned initiation of two clinical
studies, offset by a decrease in SG&A expenses. .
Cash & Cash Equivalents
As of June 30, 2020, we had cash and cash equivalents of $63.0
million, compared to $4.4 million at December 31, 2019. We believe that our cash and cash equivalents will provide sufficient resources
for our current ongoing needs through fiscal year 2024.
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is a clinical-stage
company focusing on 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 and CM-24. NT-219 is a small molecule
targeting the novel cancer drug resistance pathways IRS1/2 and STAT3. Kitov is currently advancing NT-219 as a monotherapy treatment
of advanced solid tumors and in combination with cetuximab for the treatment of recurrent or metastatic squamous cell carcinoma
of head and neck cancer (SCCHN) in a planned phase 1/2 study. CM-24 is a monoclonal antibody blocking CEACAM1, a novel immune checkpoint
that supports tumor immune evasion and survival through multiple pathways. Kitov plans to advance CM-24 as a combination therapy
with anti-PD1 checkpoint inhibitors in selected cancer indications in a phase 1 study followed by a phase 2 for the treatment of
non-small cell lung cancer NSCLC and pancreatic cancer. Kitov has entered into a clinical collaboration agreement with Bristol
Myers Squibb Company for the planned phase 1/2 clinical trials to evaluate the combination of CM-24 with the PD-1 inhibitor nivolumab
(Opdivo ). Kitov is also the owner of Consensi , a fixed-dose combination of celecoxib and amlodipine besylate, for the
simultaneous treatment of osteoarthritis pain and hypertension that was approved by the FDA for marketing in the U.S. Consensi
is being sold in the U.S. by Burke Therapeutics, the marketing partner of Kitov's U.S. distributor, 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 plans, strategies and objectives of management
for future operations; product development for NT219 and CM-24; the process by which early stage therapeutic candidates such as
NT219 and CM-24 could potentially lead to an approved drug 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 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 obtained by competitors; dependence on the effectiveness of our patents and other protections for
innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or
infringement action against our patents, and 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, and other factors that are discussed
Last updated: Aug 11, 2020