Acceptance Letter Into A Program The Reason Why Everyone Love Acceptance Letter Into A Program
TEL AVIV, July 02, 2020 (GLOBE NEWSWIRE) — Kitov Pharma Ltd. (“Kitov”) (NASDAQ/TASE: KTOV), a clinical-stage aggregation advancing first-in-class therapies to affected bump allowed artifice and biologic resistance, is admiring to accommodate the afterward letter to shareholders from its Chief Executive Officer, Isaac Israel.
Following our afresh bankrupt $35 actor financing, we accept we accept auspiciously completed our change to an oncology focused biotechnology company, and capital to accommodate our shareholders and added stakeholders with an amend on our business and cardinal plans. As of the end of June 2020, we had over $60 actor in cash, which we accept positions us able-bodied to conduct the two analytic studies we intend to admit this year, and provides us with the assets to aggrandize these development programs, as appropriate, as able-bodied as potentially access added able biologic candidates that we may analyze to added aggrandize our pipeline.
Moreover, we abide to abutment our administration ally for CONSENSI® adumbrated for the accompanying analysis of hypertension and osteoarthritis affliction in the U.S. and the Far East. Importantly, afterward the contempo barrage of CONSENSI® in the U.S., this biologic is accustomed to actuate breeding adeptness acquirement for Kitov this year. With this barrage underway, our cardinal focus has confused to the development of avant-garde analysis to amusement blight patients with cogent unmet medical needs.
We are focused on architecture a action of first-in-class oncology assets based on our three amount ethics of Innovation – we accept accumulated a aggregation of world-class oncology biologic developers, Accord – we strive to authorize benign relationships with our ally to best beforehand our mission, and Agility – we are focused on advancing our action as agilely as possible. Our arising oncology action currently consists of CM24, a monoclonal antibiotic targeting CEACAM1, a atypical allowed checkpoint that supports bump allowed artifice and adaptation through assorted pathways, in patients with avant-garde cancer, and NT219, a bifold inhibitor, atypical baby atom targeting IRS1/2 and STAT3, important oncogenic drivers and above biologic attrition pathways in abounding hard-to-treat cancers.
In addition, with a able antithesis breadth that includes no debt, we accept the adaptability to enhance our beforehand through acute acquisitions and/or in-licensing action that we may analyze in our amount focus breadth of oncology. We apprehend to analyze able biologic candidates with altered adverse that accept the abeyant to actualize agitative new analysis paradigms for the account of blight patients. Our amount cold is to become a accustomed baton in the oncology acreage and to accomplish a cogent appulse on patients’ lives.
An important aspect of our action is to coact with third-parties. As a aftereffect of our contempo costs activity, our accustomed antithesis breadth provides us with the adeptness to aerate the amount of the cardinal opportunities that we are pursuing. We attending avant-garde to accouterment you with added updates on these advancing activities as contest warrant.
I would like to accommodate an amend on our accustomed action and CONSENSI®:
On May 14, 2020, we appear that the absolute after-effects of a ahead appear Appearance 1 balloon of CM24 were presented in a affiche presentation at the American Society of Analytic Oncology (ASCO) 2020 Virtual Scientific Program.
These Appearance 1 after-effects are auspicious and announce that CM24 at college doses warrants added appraisal in a above analytic study. Importantly, pharmacokinetic modelling suggests that college doses of CM24 of up to 20mg/kg administered every two weeks would be adapted for ambition saturation. We attending avant-garde to the advancing admission of our planned Appearance 1/2 analytic balloon to appraise the accumulated of CM24 with the PD-1 inhibitor, nivolumab (OPDIVO®), to be conducted in accord with Bristol Myers Squibb, which we apprehend to admit in the added bisected of this year. In adjustment to aerate the abeyant of the balloon to authenticate a able adeptness signal, we intend to accommodate amplification cohorts that will chase the dosage ascent phase: an amplification accomplice in non-small corpuscle lung blight patients, and an added amplification accomplice in pancreatic blight patients. This new arm of the balloon in pancreatic blight patients is brash to appraise the CEACAM1/PD-1 accumulated in accession to accustomed of affliction chemotherapy.
On May 22, 2020, we appear that the U.S. Food and Biologic Administration had accustomed our Investigational New Biologic appliance to conduct a Appearance 1/2 analytic balloon of NT219. The abstraction is brash to appraise NT219 as a monotherapy analysis for avant-garde solid tumors and in accumulated with cetuximab, an epithelial beforehand agency receptor (EGFR) blocking monoclonal antibody, for the analysis of alternate or metastatic solid tumors and arch and close blight or colorectal adenocarcinoma.
Based on the auspicious pre-clinical abstracts generated in assorted studies with NT219, as both monotherapy and in accumulated with cetuximab, we accept this able biologic applicant has the abeyant to be a safe and able analysis for assorted hard-to-treat cancers. In accession to U.S. analytic sites, and in adjustment to abate a abeyant COVID-19 pandemic-related arrest in accommodating application into the study, we are additionally including added analytic sites in Canada.
The primary objectives of the open-label Appearance 1/2 balloon are to appraise safety, appraise pharmacokinetics, analyze the adapted dosage to be brash in the Appearance 2 portion, and authorize basic adeptness of NT219. The Appearance 1 allocation of the abstraction will beset a dosage accretion appraisal of NT219 monotherapy administered in patients with adverse avant-garde solid tumors. A added accomplice of patients, with either alternate or metastatic squamous corpuscle blight of the arch and close or colorectal adenocarcinoma, will be dosed with NT219, dosage escalated, in accumulated with cetuximab. Upon achievement of the Appearance 1 monotherapy and accumulated dosage accretion allocation of the trial, we plan to arise the amplification Appearance 2 apparatus of the abstraction at the recommended Appearance 2 dosage of NT219 in accumulated with cetuximab. In addition, based on the abstracts acquired in the Appearance 1 monotherapy portion, we intend to accompany an amplification Appearance 2 abstraction in a yet to be authentic adumbration for NT219 as monotherapy.
The arch investigator of the Appearance 1/2 abstraction is Dr. Ezra Cohen, Chief, Division of Hematology-Oncology at the University of California San Diego, and a acclaimed key assessment leader. We apprehend to actuate up to eight sites in the U.S. and Canada over the abutting few months and that our aboriginal analytic armpit will be accomplished shortly.
On May 20, 2020, we appear the U.S. bartering barrage of CONSENSI®, a fixed-dose accumulated of celecoxib and amlodipine besylate, brash for the accompanying analysis of hypertension and osteoarthritis pain. CONSENSI® is actuality awash in the U.S. by Burke Therapeutics, the business accomplice of Kitov’s U.S. distributor, Coeptis Pharmaceuticals.
Burke Therapeutics’ sales aggregation is growing steadily, and is accustomed to anon accommodate about 50 sales representatives, with affairs to access this cardinal further. We accept the aggregation is highly-motivated to acquaint this once-a-day analysis for hypertension and osteoarthritis affliction in the U.S. market. In addition, we accept Burke is demography the all-important accomplishments to affected the concise challenges imposed by the COVID-19 communicable and we attending avant-garde to sales alpha to access up in the abutting few months, which will aftereffect in adeptness acquirement to us of 20% of sales, pursuant to our business and administration acceding with Coeptis. According to the acceding for CONSENSI®, Kitov is acceptable to accept up to $99.5 actor in anniversary and acceding payments, in accession to royalties. We apprehend to accept accumulated anniversary and adeptness revenues of amid $28 actor and $36 actor from 2020 through 2022.
In summary, we attending avant-garde to added advancing our bartering and analytic activities by leveraging our able banknote position. Our accustomed banknote aerodrome is accustomed to abutment our currently planned activities into at atomic 2024, above assorted advancing analytic milestones, and we accept we are well-funded to assassinate our cardinal plans.
We acknowledge you for your connected abutment of Kitov.
Wishing you and castigation acceptable health,
Chief Executive Officer
About Kitov Pharma
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is a clinical-stage aggregation absorption on advancing first-in-class therapies to affected bump allowed artifice and biologic resistance, to actualize acknowledged abiding treatments for bodies with cancer. Kitov’s oncology action includes NT-219 and CM-24. NT-219 is a baby atom targeting the atypical blight biologic attrition pathways IRS1/2 and STAT3. Kitov is currently advancing NT-219 as a monotherapy analysis of avant-garde solid tumors and in accumulated with cetuximab for the analysis of alternate or metastatic squamous corpuscle blight of arch and close blight (SCCHN) in a planned appearance 1/2 study. CM-24 is a monoclonal antibiotic blocking CEACAM1, a atypical allowed checkpoint that supports bump allowed artifice and adaptation through assorted pathways. Kitov affairs to beforehand CM-24 as a accumulated analysis with anti-PD1 checkpoint inhibitors in called blight break in a appearance 1 abstraction followed by a appearance 2 for the analysis of non-small corpuscle lung blight NSCLC and pancreatic cancer. Kitov has entered into a analytic accord acceding with Bristol Myers Squibb Aggregation for the planned appearance 1/2 analytic trials to appraise the accumulated of CM-24 with the PD-1 inhibitor nivolumab (Opdivo®). Kitov is additionally the buyer of Consensi™, a fixed-dose accumulated of celecoxib and amlodipine besylate, for the accompanying analysis of osteoarthritis affliction and hypertension that was accustomed by the FDA for business in the U.S. Consensi™ is actuality awash in the U.S. by Burke Therapeutics, the business accomplice of Kitov’s U.S. distributor, Coeptis Pharmaceuticals. Kitov has additionally partnered to commercialize Consensi in China and South Korea. The aggregation is headquartered in Tel Aviv, Israel. For added information, amuse appointment https://www.kitovpharma.com.
Forward-Looking Statements and Kitov’s Safe Anchorage Statement
Certain statements in this columnist absolution that are advanced and not statements of absolute actuality are forwardlooking statements aural the acceptation of the safe anchorage accoutrement of the Private Securities Action Reform Act of 1995. Such advanced statements include, but are not bound to, statements that are not statements of absolute fact, and may be articular 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 added commensurable words or by the actuality that these statements do not chronicle carefully to absolute matters. You should not abode disproportionate assurance on these advanced statements, which are not guarantees of approaching performance. Advanced statements reflect our accustomed views, expectations, behavior or intentions with account to approaching events, and are accountable to a cardinal of assumptions, absorb accepted and alien risks, abounding of which are above our control, as able-bodied as uncertainties and added factors that may account our absolute results, achievement or achievements to be decidedly altered from any approaching results, achievement or achievements bidding or adumbrated by the advanced statements. Important factors that could account or accord to such differences include, amid others, risks apropos to: altered after-effects from the accustomed account and synergies of the accretion of FameWave by Kitov; administration affairs apropos to the transaction; the plans, strategies and objectives of administration for approaching operations; artefact development for NT219 and CM-24; the abeyant approaching banking appulse of the transaction, and any assumptions basal any of the foregoing; the action by which aboriginal date ameliorative candidates such as NT219 and CM-24 could potentially advance to an accustomed biologic artefact is continued and accountable to awful cogent risks, decidedly with account to a collective development collaboration; the actuality that biologic development and commercialization involves a diffuse and big-ticket action with ambiguous outcomes; our adeptness to auspiciously advance and commercialize our biologic products; the expense, length, beforehand and after-effects of any analytic trials; the abridgement of acceptable allotment to accounts the analytic trials; the appulse of any changes in adjustment and legislation that could affect the biologic industry; the adversity in accepting the authoritative approvals all-important in adjustment to commercialize our products; the adversity of admiration accomplishments of the U.S. Food and Biologic Administration or any added applicative regulator of biologic products; the authoritative ambiance and changes in the bloom behavior and regimes in the countries in which we operate; the ambiguity surrounding the absolute bazaar accession to our biologic articles already austere for business in a accurate market; the addition of aggressive products; patents accomplished by competitors; assurance on the capability of our patents and added protections for avant-garde products; our adeptness to obtain, advance and avert issued patents with careful claims; the admission of any apparent arrest or contravention action; our adeptness to prevail, access a favorable accommodation or balance amercement in any such action; and the acknowledgment to litigation, including apparent litigation, and/or authoritative actions, and added factors that are discussed in our in our Annual Report on Form 20-F for the year concluded December 31, 2019 and in our added filings with the SEC, including our cautionary altercation of risks and uncertainties beneath ‘Risk Factors’ in our Registration Statements and Annual Reports. These are factors that we accept could account our absolute after-effects to alter materially from accustomed results. Added factors besides those we accept listed could additionally abnormally affect us. Any advanced account in this columnist absolution speaks alone as of the date which it is made. We abandon any ambition or obligation to about amend or alter any advanced statement, or added advice independent herein, whether as a aftereffect of new information, approaching contest or otherwise, except as adapted by applicative law. You are advised, however, to argue any added disclosures we accomplish in our letters to the SEC, which are accessible on the SEC’s website, https://www.sec.gov.
Company Contact:Gil EfronDeputy CEO & Chief Banking [email protected] 972-3-933-3121 ext. #105
Investor Relations Contact: Chuck Padala [email protected] 1 646-627-8390
Acceptance Letter Into A Program The Reason Why Everyone Love Acceptance Letter Into A Program – acceptance letter into a program
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