Kitov Pharma Provides Corporate Update and Reports Full-Year 2019 Financial Results

Pharma Provides Corporate Update and Reports Full-Year 2019 Financial Results

AVIV, Israel, February 11, 2020 (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 provided a corporate update

and announced financial results for the six-months and full year ended December

recently completed year represented a transformational period for Kitov that was marked by significant progress in multiple key

areas of our business," said Isaac Israel, CEO of Kitov. "Our acquisition of FameWave added an additional exciting

oncology product candidate to our pipeline. With CM-24 and NT-219, we now have two promising oncology-focused drug candidates

which we intend to enter the clinic this year. We have assembled a seasoned oncology clinical development team with senior and

experienced executives, and we are well positioned to execute on our plans. We expect the imminent launch of Consensi in the U.S.

with strong distribution partners in place to begin commercialization in 2020. Finally, our balance sheet was strengthened early

in 2020 when OrbiMed, Pontifax and Arkin Holdings invested $3.5 million of cash in Kitov, equates to a proforma cash position

of approximately $9.5 million. An additional stream of revenues expected to be generated from royalties related to sales of Consensi

will further support our core oncology development programs.

& Achievements in 2019 and to Date:

appointments to management team and Board of Directors:

is a clinical-stage monoclonal antibody blocking CEACAM1, a well-validated target which is highly expressed in many solid tumors

as well as on immune cells and plays a pivotal role in the immune system. In a monotherapy phase 1 study, CM-24 demonstrated safety

and efficacy with standard dose in about 30% of patients.

CM-24 achievements include:

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.

NT-219 achievements include:

a fixed-dose combination of celecoxib and amlodipine besylate was approved by the U.S. Food and Drug Administration (FDA) for

marketing in the U.S and is expected to be launched in the U.S. during 2020 by Kitov's partner Coeptis Pharmaceuticals. Kitov has

also partnered to commercialize Consensi in China and South Korea.

ConsensiTM achievements include:

US Prescribing Information, including BOXED WARNING and Medication Guide is available at: www.consensi.com.

Results for the Year Ended December 31, 2019

revenues for the year ended December 31, 2019, were $1.0 million, compared to $1.0 million in the year ended December 31, 2018.

The revenues for the year ended December 31, 2019, consisted of the first milestone payment related to ConsensiTM development

from Coeptis Pharmaceuticals.

and Development Expenses

and development (R&D) expenses for the year ended December 31, 2019, were $2.7 million, a decrease of $2.6 million, or

49.3%, compared to $5.3 million for the year ended December 31, 2018. The decrease in research and development expenses

resulted primarily from a decrease in costs related to the clinical development of ConsensiTM following FDA approval of the drug.

General and Administrative Expenses

General and administrative (SG&A) expenses for the year ended December 31, 2019, were $6.1 million, an increase of $0.9

million, or 18.6%, compared to $5.2 million for the year ended December 31, 2018. The increase in selling, general and

administrative expenses resulted primarily from a $0.9 million annual fee paid to the FDA related to ConsensiTM which

will be assumed by our marketing partner in the US starting from 2020.

loss for the year ended December 31, 2019, were $7.2 million, a decrease of $0.6 million, or 8.5%, compared to $7.8 million for

the year ended December 31, 2018.

a non-IFRS basis (as described and reconciled below), adjusted operating loss for the year ended December 31, 2019, was $5.9

million, a decrease of $1.2 million from $7.1 million for the year ended December 31, 2018. The decrease was due to the

decrease in R&D expenses mentioned above and a decrease in various SG&A expenses offset by a one-time increase in FDA

fee and a one-time decrease in other income.

loss for the year ended December 31, 2019, was $5.9 million, or ($0.30) per diluted share, compared to $5.6 million, or ($0.39)

per diluted share, for the year ended December 31, 2018.

loss for the year ended December 31, 2019, was $5.9 million, or ($0.30) per diluted share, compared to $5.6 million, or ($0.39)

per diluted share, for the year ended December 31, 2018.

Results for the 6 months Ended December 31, 2019

and Development Expenses

R&D expenses for the six-month period ended December 31, 2019, were $1 million, a decrease of $1.4 million, or 58.3%,

compared to $2.4 million for the six-month period ended December 31, 2018. The decrease in research and development expenses resulted

primarily from a decrease in costs related to the development of ConsensiTM and decrease in preclinical development

General and Administrative Expenses

SG&A expenses for the six-month

period ended December 31, 2019, were $2.8 million, an increase of $1 million, or 55.5%, compared to $1.8 million for the

six-month period ended December 31, 2018. The increase in SG&A expenses resulted primarily from the one-time fee paid to

the FDA relating to ConsensiTM as mentioned above and increase in employees stock option costs.

loss for the six-month period ended December 31, 2019, was $3.6 million, an increase of $0.2 million, or 5.9%, compared to $3.4

million for the six-month period ended December 31, 2018.

a non-IFRS basis (as described and reconciled below), adjusted operating loss for the six-month period ended December 31,

2019, was $2.8 million, a decrease of $0.5 million from $3.3 million for the six-month period ended December 31, 2018.

The decrease was due to the decrease in R&D expenses mentioned above and a decrease in various SG&A expenses offset

by a one-time increase in FDA fee.

loss for the six-month period ended December 31, 2019, was $3.3 million, or $0.17 per diluted share, compared to $0.4 million,

or $0.02 per diluted share, for the six-month period ended December 31, 2018. The increase in net loss was mainly due to decrease

of $2.6M in income from a change in the fair value of derivatives.

December 31, 2019, the Company had $4.4 million in cash and cash equivalents compared to $5.2 million at the end of December 2018.

In January 2020, Kitov received a $1.5 million milestone payment from Coeptis. This payment, in addition to the $3.5 million financing

from Pontifax, Orbimed and Arkin, equates to a proforma cash position of approximately $9.5 million at December 31, 2019.

operating loss is defined as operating loss, plus non-cash share-based compensation expenses. Our management believes that excluding

non-cash charges related to share-based compensation provides useful information to investors because of its non-cash nature,

varying available valuation methodologies among companies and the subjectivity of the assumptions and the variety of award types

that a company can use under the relevant accounting guidance, which may obscure trends in our core operating performance. We

present adjusted operating loss because we use this non-IFRS financial measures to assess our operational performance, for financial

and operational decision-making, and as a means to evaluate period-to-period comparisons on a consistent basis. Management believes

this non-IFRS financial measure is useful to investors because: (1) it allows for greater transparency with respect to key metrics

used by management in its financial and operational decision-making; and (2) it exclude the impact of non-cash item that is not

directly attributable to our core operating performance and that may obscure trends in the core operating performance of the business.

Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation from, or as a substitute

for, our IFRS results. We expect to continue reporting non-IFRS financial measures, adjusting for the item described above, and

we expect to continue to incur expenses similar to certain of the non-cash, non-IFRS adjustments described above. Accordingly,

unless otherwise stated, the exclusion of this and other similar items in the presentation of non-IFRS financial measures should

not be construed as an inference that these items are unusual, infrequent or non-recurring. Adjusted operating loss is not a recognized

term under IFRS and do not purport to be an alternative to IFRS net operating loss as an indicator of operating performance or

any other IFRS measure. Moreover, because not all companies use identical measures and calculations, the presentation of adjusted

operating loss may not be comparable to other similarly titled measures of other companies.

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 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). CM-24 is 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).

Kitov has entered into a clinical collaboration agreement with Bristol Myers Squibb Company (NYSE:BMY) 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 which was approved by the FDA for marketing in the U.S and is expected to be launched in the