On February 7, 2019 Kitov Pharma (NASDAQ/TASE: KTOV), an innovative pharmaceutical company, reported its unaudited financial results for the year ended December 31, 2018 and provided a business update (Press release, Kitov Pharmaceuticals , FEB 7, 2019, View Source [SID1234533116]).
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Highlights & Achievements in 2018 and to Date:
Approximately $13 million cash on hand at the beginning of 2019 based on a reported cash balance of $6.7 million on December 31, 2018, plus net $5.5 million raise through financing in January, and a $1 million milestone payment from Kitov’s U.S. distributor for Consensi.
$4.2 million decrease in loss from operations to $7.8 million in 2018 from $12.0 million in 2017 and a $7.3 million decrease in net loss to $5.6 million in 2018 from $12.9 million in 2017.
72% decrease in loss per diluted share to $0.39 in 2018 from $1.38 in 2017.
R&D expenses in 2018 were approximately $5.3 million compared to $4.6 million in 2017.
Consensi was approved by the U.S. FDA in June 2018 and is licensed for commercialization in the U.S., China, and South Korea;
"We are very proud of the major achievement of gaining FDA approval for our lead drug candidate, Consensi, as well as the excellent progress we have made in our NT-219 pre-clinical development program during 2018," stated Isaac Israel, Chief Executive Officer of Kitov Pharma. "We are working productively with Coeptis Pharmaceuticals and its outstanding team to launch Consensi in the U.S. market to create better patient compliance and improved treatment for people living with osteoarthritis pain and hypertension. Additionally, we are very satisfied with the on-target execution of our NT-219 oncology program and we look forward to initiating clinical trials later this year. We are committed to continuing to unlock substantial value in our business by leveraging our team’s deep regulatory expertise and drug development experience, complemented by targeted business development efforts, in order to maximize the potential of our therapeutic candidates. We strengthened our balance sheet recently with the additional gross financing of $6 million in January 2019 as we progress with our goals to achieve a major clinical milestone with NT-219."
NT-219 – Small Molecule Oncology Drug
NT-219 is a first-in-class small molecule targeting both Insulin Receptor Substrates (IRS) 1/2 and Signal Transducer and Activator of Transcription 3 (STAT3), two signal proteins that are part of an anti-cancer drug resistance mechanism.
Key NT-219 achievements include:
Positive results were reported in a pre-clinical study which evaluated NT-219 in combination with gemcitabine in a patient-derived xenograft (PDX) model of pancreatic cancer. The study was conducted in accordance with guidance from the U.S. FDA and the results support the planned submission of an Investigational New Drug (IND) application for NT-219. Kitov is preparing for initiation of clinical trials in 2019.
At the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in New York, Kitov presented an abstract in a poster session demonstrating NT-219’s efficacy in synergy with immuno-oncology therapies, which are widely used today, but to which unfortunately, most patients still do not respond. In double autologous PDX models, dosing with NT-219 converted tumors that were resistant to pembrolizumab (Keytruda) into responsive tumors. The models also demonstrated the efficacy of NT-219 in enhancing the immunotherapeutic potential of cetuximab (Erbitux).
Kitov announced new findings from the Company’s ongoing collaboration with researchers from the Hebrew University of Jerusalem. The data reveal NT-219’s high affinity and selective binding to its target proteins, demonstrating that NT-219 binds directly to IRS1/2 and to STAT3, both known modulators of tumor survival, metastasis and drug resistance. Data showed that a short exposure of cancerous cells to NT-219 was sufficient to trigger irreversible shutdown of these pathways, resulting in a long-term anti-cancer effect.
Consensi
Consensi, a combination drug that simultaneously treats pain caused by osteoarthritis and treats hypertension, is comprised of two FDA approved drugs, 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. Hypertension is one of the side effects of using NSAIDs including celecoxib.
Consensi, under patent protection in the U.S. until 2030, and will be the only NSAID whose labeling indicates a reduction of blood pressure and consequent risk reduction of heart attack, stroke, and death. The therapy may contribute to improved patient compliance and improved patient health, thereby lowering overall health care costs.
Kitov currently has three signed licensing and distribution agreements for the drug in the U.S., China and South Korea. The Company believes that successful commercialization of Consensi in the U.S. by Coeptis Pharmaceuticals will be a transformational value-creating event for Kitov.
Key Consensi accomplishments include:
The FDA approved Consensi for marketing in the U.S. for once daily use in three dosage forms, corresponding to the current approved dosages of amlodipine (2.5, 5, and 10 mg) for hypertension and a 200 mg dose of celecoxib for the treatment of osteoarthritis pain.
Kitov signed a definitive License Agreement for Consensi with Hebei Changshan Biochemical Pharmaceutical Co., Ltd. (CSBio), a Chinese public company traded on the Shenzhen Stock Exchange. Upon receipt of marketing authorization in China, CSBio will have the exclusive right and license to import, manufacture, distribute, and sell Consensi in China. Under the terms of the agreement, Kitov is entitled to receive up to an aggregate of $3.5 million for regulatory milestones, of which Kitov has already received $1 million. In addition, Kitov is entitled to receive up to an aggregate of $6.0 million for predefined commercial milestones and up to 12% royalties on net sales.
Kitov signed an exclusive marketing and distribution agreement with Coeptis Pharmaceuticals for the U.S. market. The agreement provides for total milestone payments from Coeptis to Kitov of $3.5 million, of which Kitov has already received $1 million upon execution of the agreement, and additional milestone payments are due upon completion of an agreed manufacturing plan and upon first commercial sales in the U.S. In addition, Kitov will be paid 40%-60% of Coeptis’ net profit on Consensi sales.
Expected Significant Upcoming Kitov Milestones for 2019:
Complete pre-clinical development plan for NT-219; submit an IND application to the FDA; and start clinical trials in combination with approved oncology drugs to increase efficacy, expand target populations and treatment duration.
Execute collaboration agreements with potential strategic partners for the development of NT-219.
In-license at least one additional oncology drug candidate, either at a late pre-clinical or early/mid-stage clinical stage.
Complete preparation for launch of Consensi in the U.S. with commercial partner Coeptis Pharmaceuticals.
Financial Results for the Year Ended December 31, 2018
Research and development expenses for the year ended December 31, 2018 were $5.3 million, an increase of $0.7 million, or 15.2%, compared to $4.6 million for the year ended December 31, 2017. The increase resulted primarily from higher expenses in 2018 associated with NT-219 preclinical and CMC development. Kitov expects a similar level of R&D expenditure, mainly for the development of NT-219, in 2019.
General and administrative expenses, including reimbursement from insurance for legal fees, for the year ended December 31, 2018 were $4.5 million, a decrease of $1.9 million, or 29.7%, compared to $6.4 million for the year ended December 31, 2017. The decrease resulted primarily from higher legal expenses in 2017 associated with class action claims and reimbursement for these legal fees in 2018.
Kitov’s operating loss for the year ended December 31, 2018 amounted to $7.8 million, compared with an operating loss of $12 million for the year ended December 31, 2017, a 35% decrease. The decrease in operating loss reflects $1 million in revenue in 2018 and the significant decrease in general and administrative expenses as mentioned above during 2018 offset by an increase in research and development expenses.
Kitov’s net loss for the year ended December 31, 2018 amounted to $5.6 million, compared with a net loss of $12.9 million for the year ended December 31, 2017 as a result of the decrease in operating loss mentioned above, finance income of $2.3 million in 2018, mainly a result of decrease in fair value of derivatives compared to finance expenses of $1 million in 2017, mainly a result of increase in fair value of derivatives.
Kitov held $6.7 million in cash, cash equivalents and short-term bank deposits as of December 31, 2018. After the end of 2018, Kitov raised a net of $5.5 million through an offering in January 2019.
Financial Results for the 6 Months Period Ended December 31, 2018
Research and development expenses for the six-month period ended December 31, 2018 were $2.4 million, an increase of $0.3 million, or 14.3%, compared to $2.1 million for 2nd half of 2017. The increase resulted primarily from higher expenses in 2018 associated with preclinical and CMC development for NT-219.
General and administrative expenses, including reimbursement from insurance for legal fees, for the six-month period ended December 31, 2018 were $1.1 million, a decrease of $2.8 million, or 71.8%, compared to $3.9 million for the six-month period ended December 31, 2017. The decrease resulted primarily from decrease in legal and consulting expenses, reimbursement from insurance and decrease in salary related expenses including ESOP costs in 2018.
Kitov’s operating loss for the six-month period ended December 31, 2018 amounted to $3.5 million, compared with an operating loss of $6.0 million for the six-month period ended December 31, 2017. The decrease in operating loss reflects the significant decrease in general and administrative expenses as mentioned above during 2018.
Kitov’s net loss for the six-month period ended December 31, 2018 amounted to $0.4 million, compared with a net loss of $6.9 million for the six-month period ended December 31, 2017.
About Consensi
Full US Prescribing Information, including BOXED WARNING and Medication Guide is available at: www.consensi.com.
Indications and Usage:
Consensi is a combination of amlodipine besylate, a calcium channel blocker, and celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), indicated for patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal CV events, primarily strokes and myocardial infarctions.
Limitations of Use:
Consensi is only available in a celecoxib strength of 200 mg and is only to be taken once daily.
Important Safety Information (ISI) for Consensi
The following ISI is based on the Highlights section of the U.S. Prescribing Information for Consensi. Please consult the full Prescribing Information for all of the labelled safety information for Consensi.
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
Consensi is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Consensi is contraindicated in patients with a known hypersensitivity to amlodipine, celecoxib or any of its inactive ingredients.
Consensi is contraindicated in patients with a known history of asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs and in the setting of CABG surgery.
Consensi is contraindicated in patients with known demonstrated allergic-type reactions to sulfonamides.
Significant warnings and precautions related to Consensi include the following:
Patients should be warned about the potential signs and symptoms of hepatotoxicity and hepatic failure. Physicians should discontinue Consensi if abnormal liver tests persist or worsen, or if clinical signs and symptoms of liver disease develop.
Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Physicians should carefully monitor blood pressure.
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis.
Worsening angina and acute myocardial infarction, particularly in patients with severe obstructive coronary artery disease, is possible.
Physicians should avoid use of Consensi in patients with severe heart failure.
Physicians should monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia, and avoid the use of Consensi in patients with advanced renal disease.
Patients should seek emergency help if an anaphylactic reaction occurs.
Consensi is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
Physicians should discontinue Consensi at the first appearance of skin rash or other signs of hypersensitivity.
NSAIDs such as Consensi can cause premature Closure of Fetal Ductus Arteriosus.
Avoid use in pregnant women starting at 30 weeks of gestation.
Physicians should monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
Consensi is not recommended in patients with moderate or severe hepatic impairment or severe renal insufficiency.
Consensi is not recommended in Poor Metabolizers of CYP2C9 Substrates.
To report SUSPECTED ADVERSE REACTIONS, contact Kitov Pharma at 1-800-651-6606 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch