Full Press Release Details
Kitov Pharma Reports First Half 2019 Financial Results and Provides
TEL AVIV, Israel, Aug.
08, 2019 (GLOBE NEWSWIRE) -- 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 financial results for the six-month period ended
Key Financial Highlights
for the first half of 2019:
| Revenues of $1 million as a result of the first milestone payment from Coeptis Pharmaceuticals. | ||
| Decrease in research and development expenses to $1.7 million compared to $2.8 million in 1H18. | ||
| SG&A expenses of $3.3 million, similar to 1H18. | ||
| Net cash used in operating activities decreased to $2.3 million compared to $3.5 million in 1H18. | ||
| Net cash balance and short-term deposits at the end of 1H19 of $7.8 million, not including $3.5 million investment in Kitov by Orbimed, Pontifax and Arkin expected following completion of the FameWave acquisition. |
Isaac Israel, chief executive
officer of Kitov Pharma, commented, "During the first half of 2019, we made a great progress in the acquisition of FameWave
announced earlier this year, with fulfillment of the major closing conditions including the clinical collaboration agreement signed
with BMS. This acquisition of a clinical stage oncology asset is a major step in our shift towards an oncology focused company.
With the recent successful completion of the IND-enabling studies to advance NT-219 into the clinic and the almost completed acquisition
of CM-24, we will soon initiate clinical trials with both candidates which we believe have a great potential to provide effective
and long-lasting treatments for patients."
Mr. Israel added, "We
have additionally achieved significant milestones with Consensi during this period. With our plans to launch in the U.S.,
through our partnership with Coeptis Pharmaceuticals, we are already bringing additional revenues to support our oncology programs.
The success of this program is also a reflection of our team's ability to successfully execute end-to-end development of
Key Research and Development
NT-219 is a first-in-class
small molecule dual inhibitor of STAT3 and IRS1/2, with the potential to prevent and overcome drug resistance in various cancer
types when used in combination with existing agents. Key achievements for the NT-219 program for the six-month period ended June
| Completed IND-enabling studies to advance NT-219 for the treatment of patients with recurrent or metastatic head and neck cancers. | ||
| Planned Phase 1/2 open label multi-center study which will include a dose escalation with fewer than 20 patients and an expansion cohort with 30 patients, to investigate NT-219 in combination with cetuximab in patients with recurrent and metastatic squamous cell carcinoma of head & neck cancer (SCCHN). The main goal of the study is to evaluate the safety, tolerability and maximum tolerated dose, with a secondary endpoint to obtain preliminary efficacy data. | ||
| Announced new findings related to NT-219 mechanism of action showing that even a short exposure of cancerous cells to NT219 was sufficient to trigger irreversible shutdown of cancer pathways, resulting in a long-term anti-cancer effect. These new findings suggested that IRS1/2 dissociates from the cell membrane, undergoes serine phosphorylation which prevents rebinding to the receptor, and is finally degraded by the proteasome. This sequence of events leads to the blockage of PI3K - AKT pathway - a major cancer cell survival pathway. |
CM-24 is a clinical-stage
monoclonal antibody antagonist of CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple
pathways. Kitov plans to develop CM-24 as a combination therapy with the PD-1 checkpoint inhibitor nivolumab (Opdivo ) in clinical
collaboration with Bristol-Myers-Squibb (BMS) to treat non-small cell lung cancer (NSCLC) patients. Key achievements for the CM-24
program for the six-month period ended June 30, 2019 include:
| Announced signature of agreement to acquire FameWave Ltd., a privately held biopharmaceutical company developing CM-24. | ||
| Announced key milestone in the acquisition of FameWave, with the signature of a clinical collaboration agreement between FameWave and BMS for a Phase 1/2 clinical trials to evaluate the combination of CM-24 with nivolumab (Opdivo ), BMS's PD-1 inhibitor, in NSCLC. | ||
| The safety profile of CM-24 was previously evaluated and found to be well tolerated in a Phase 1 study conducted by Merck at doses up to 10mg/kg. Analysis of the Phase 1 data suggested that CEACAM-1 receptor saturation requires a higher dose of CM-24, which is expected be achieved with less than 20mg/kg if administrated every two weeks. Kitov believes that the combination of CM-24 with Opdivo is advantageous over Merck's pembrolizumab (Keytruda ) due to Opdivo 's Q2W administration protocol, compared to the Q3W administration protocol for Keytruda . | ||
| FameWave entered into a manufacturing agreement with its contract manufacturer for the production of CM-24 for the planned Phase 1/2 study. |
Consensi is a fixed-dose
combination of celecoxib (Celebrex), a non-steroidal anti-inflammatory drug (NSAID) for the treatment of pain caused by osteoarthritis,
and amlodipine besylate (Norvasc), a drug designed to treat hypertension. Consensi is under patent protection in the
U.S. until 2030 and is the only NSAID whose labeling indicates a reduction of blood pressure and consequent risk reduction of heart
attack, stroke, and death. Kitov plans to use revenue from milestone payments from multiple regional licensing deals for Consensi
to advance its oncology pipeline. Key achievements for the Consensi program for the six-month period ended June 30, 2019
| Submit IND for the initiation of Phase 1/2 study with NT-219 in combination with cetuximab in patients with recurrent and metastatic SCCHN. | ||
| Complete closing of transaction for the acquisition of FameWave and its CM-24 candidate | ||
| Complete preparation for launch of Consensi in the U.S. with commercial partner Coeptis Pharmaceuticals. | ||
| Submit marketing approval applications to the local regulatory authorities for potential registration of Consensi in China which will trigger an additional milestone payment to Kitov. |
Financial Results for
the Six-Month Period Ended June 30, 2019
| Revenue for the six-month period ended June 30, 2019 was $1 million, resulting from a milestone payment from Coeptis related to Consensi in 2019, and same as in the first half of 2018 due to milestone payment from CSBio on Consensi in the first half of 2018. | ||
| Research and development expenses for the first half of the year ended June 30, 2019 were $1.7 million, a decrease of $1.1 million compared to the six-month period ended June 30, 2018. The decrease is mainly due to a reduction in clinical trials and regulatory expenses related to Consensi prior to its approval by the FDA in the first half of 2018, a decrease in bonuses accrued in the first half of 2018 in connection with FDA approval of Consensi as well as a decrease in ESOP costs in the first half of 2019 compared to the first half of 2018. | ||
| Selling, general and administrative expenses for the first half of the year ended June 30, 2019 were $3.3 million, compared to $3.4 million for the first half of year ended June 30, 2018. | ||
| Net cash used in operating activities was $2.3 million for the first half of the year ended June 30, 2019, compared to $3.5 million for the first half of year ended June 30, 2018. The decrease reflects a reduction of operating expenses of $1.2 million in the first half of 2019 compared to first half of 2018. | ||
| Kitov's operating loss for the six-month period ended June 30, 2019 amounted to $3.6 million, compared with an operating loss of $4.4 million for the six-month period ended June 30, 2018. The decrease in operating loss reflects the decrease in operating expenses as mentioned above during 2019. | ||
| Kitov's net loss for the six-month period ended June 30, 2019 amounted to $2.6 million, compared with a net loss of $5.2 million for the six-month period ended June 30, 2018. Basic and diluted loss per share in the first half of 2019 was 14 cents compared to 42 cents in the first half of 2018. | ||
| Cash, cash equivalents and short-term bank deposits totaled $7.8 million as of June 30, 2019. Upon closing of the FameWave acquisition, Kitov will receive an additional $3.5 million investment from Orbimed, Pontifax and Arkin. |
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 for the treatment of non-small cell lung
cancer (NSCLC). Following the 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 the PD-1 inhibitor nivolumab (Opdivo ), the acquisition is expected to close
during the third quarter of 2019, subject to fulfillment of certain additional closing conditions. 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
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 or NT-219 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 and the potential impact of such investigation
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.gov
For further information, contact:
Deputy CEO & Chief Financial Officer