On 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, reported financial results for the six months ended June 30, 2020 (Press release, Kitov Pharmaceuticals , AUG 11, 2020, View Source [SID1234563438]).

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"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 catalysts."

"For CM24, we presented positive Phase 1 results at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 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."

"In addition, we 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 Mr. Israel.

Recent Corporate Highlights

CM24: a monoclonal antibody targeting CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways:

Presented the positive results of a previously reported Phase 1 trial at the ASCO (Free ASCO Whitepaper) 2020 Virtual Scientific Program. These encouraging Phase 1 results indicate that CM24 at higher doses warrants further evaluation in a larger clinical study. Importantly, pharmacokinetic (PK) modelling suggests that higher doses of CM24 of up to 20mg/kg administered every two weeks would be required for target saturation.
Received a notification from the European Patent Office to grant a patent for Kitov’s application entitled "Humanized antibodies against CEACAM1," covering protein and DNA sequences pertaining to humanized antibodies capable of specific binding to human CEACAM1 molecules, including its lead monoclonal antibody, CM24, pharmaceutical compositions comprising these antibodies, as well as methods for their use in treating and diagnosing cancer and other conditions.
Currently advancing preparations to initiate a Phase 1/2 clinical trial of CM24 in combination with nivolumab (OPDIVO) in patients with non-small cell lung cancer, and in combination with nivolumab in addition to standard of care chemotherapy, in patients with pancreatic cancer. The trial will be conducted under a clinical collaboration agreement with BMS, and is expected to begin in the second half of 2020.
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 cancers:

Expanded planned Phase 1/2 clinical trial of NT219 with cetuximab trial in patients with recurrent or metastatic head and neck cancer, to also include evaluation of NT219 as monotherapy treatment in patients with advanced solid tumors, based on significant compelling preclinical evidence generated in various studies with NT219.
Presented promising preclinical data demonstrating the anti-tumor activity of NT219 as both a monotherapy and in combination with cetuximab, an EGFR blocking monoclonal antibody, at the 2020 Multidisciplinary Head and Neck Cancers Symposium.
Presented preclinical data at the American Association of Cancer Research Virtual Meeting II in a presentation entitled "NT219, a novel dual inhibitor of STAT3 and IRS1/2, demonstrates anti-tumor activity with and without cetuximab in pembrolizumab-resistant head and neck cancer PDX models." Using multiple patient derived xenograft (PDX) models of subjects with head and neck squamous cell carcinoma, NT219 demonstrated growth inhibition, both as monotherapy as well as in combination with cetuximab or pembrolizumab (KEYTRUDA), a PD-1 inhibitor .
The FDA accepted Kitov’s IND to conduct a Phase 1/2 clinical trial of NT219. The primary objectives of the open-label Phase 1/2 trial are to evaluate safety, assess PK, identify the appropriate dose to be studied in the Phase 2 portion, and establish preliminary efficacy of NT219. We initiated the study in July and expect to activate up to eight sites in the U.S. and Canada over the next few months.
CONSENSI: a fixed-dose combination of celecoxib and amlodipine besylate, designed for the simultaneous treatment of hypertension and osteoarthritis pain:

Announced the U.S. commercial launch of CONSENSI by Burke Therapeutics, the marketing partner of Kitov’s U.S. distributor, Coeptis Pharmaceuticals. Burke Therapeutics’ sales team is growing steadily, and is expected to include approximately 50 sales representatives, with plans to increase this number further.
According to our agreement with Coeptis for CONSENSI, Kitov is eligible to receive up to $99.5 million in milestone and reimbursement payments, in addition to royalties.
Kitov expects to receive aggregate milestone and royalty revenues of between $28 million and $36 million from 2020 through 2022.
Financing Activities

Raised an aggregate of approximately $54.5 million in gross proceeds from registered direct, public offering, and PIPE transactions.
Received an additional $13.9 million of gross cash proceeds from the exercise of warrants.
Financial Results for the Six Months Ended June 30, 2020

Revenues
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
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
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.