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PETACH TIKVA, Israel–()–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology firm advancing a pipeline of proprietary small molecule medication that deal with inflammatory, most cancers and liver illnesses, immediately introduced monetary outcomes for the 9 months ended September 30, 2020.

Clinical Developments and Corporate Highlights for the Third Quarter and Recent Weeks Include:

Positive Interim Analysis in Phase III Comfort™ Trial of Piclidenoson within the Treatment of Psoriasis – The Independent Data Monitoring Committee (IDMC) for Can-Fite’s Phase III trial of Piclidenoson within the therapy of moderate-to-severe plaque psoriasis beneficial the Company proceed the examine with the unique pattern measurement and drop one dose group primarily based on the constructive information from its interim evaluation. While the interim information proceed to be blinded to Can-Fite, the Company considers the IDMC’s suggestions extremely encouraging. As the optimum dose has been recognized, Can-Fite believes the examine could be concluded sooner than initially deliberate. The majority of prices related to the Phase III Comfort™ examine have been beforehand paid. Piclidenoson is out-licensed for the indication of psoriasis in 9 international locations by means of agreements that embrace milestone funds and royalties on revenues upon regulatory approval.

Data from the Interim Analysis of the Acrobat™ Rheumatoid Arthritis Study – The IDMC beneficial to not proceed this examine. The Company carried out an in depth evaluation which confirmed that though Piclidenoson efficacy was considerably superior to placebo, the examine missed the first endpoint which was non-inferiority vs. the comparator methotrexate. The Company determined to cease this Phase III examine and to give attention to the developments that confirmed promising information together with psoriasis, NASH and liver most cancers.

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Phase II COVID-19 IND Application for Piclidenoson Approved by FDA – The U.S. Food and Drug Administration (FDA) issued a “safe to proceed” discover for Can-Fite’s Investigational New Drug (IND) software for a Phase II examine of Piclidenoson within the therapy COVID-19. The 28-day examine will enroll 40 sufferers hospitalized with “moderate” COVID-19 per U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. The randomized, double blind examine will consider sufferers who will obtain Piclidenoson along with customary supportive care, as in comparison with sufferers who obtain customary supportive care with placebo. The Company expects to start affected person enrollment in This fall 2020.

Namodenoson Abstract of Phase II Data Selected as ‘Best of The Liver Meeting’ within the NASH Category of the American Association of Liver Diseases (AASLD) – Dr. Rifaat Safadi, Principal Investigator of Can-Fite’s Phase II examine of Namodenoson within the therapy of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) delivered a late-breaking oral presentation on the prestigious American Association for the Study of Liver Diseases (AASLD) convention, The Liver Meeting Digital Experience™ 2020. Presenting to the world’s main scientists and well being care professionals dedicated to stopping and curing liver illnesses, Dr. Safadi concluded that “Namodenoson’s very impressive study data may result in a promising drug for the treatment of NAFLD/NASH due to the combination of good efficacy and favorable safety.” Can-Fite’s presentation was chosen as ‘Best of The Liver Meeting’ within the NAFLD/NASH class. This choice is a singular honor and signifies the excessive degree with which the AASLD overview committee regards Can-Fite’s analysis.

Patent Protecting Namodenoson in Treatment of NASH Approved in Europe – A patent titled “An A3 Adenosine Receptor For Use In Treating Ectopic Fat Acculturation” was issued to Can-Fite by the European Patent Office. The patent’s claims embrace use of the A3 adenosine receptor (A3AR), the goal of Can-Fite’s platform expertise, in lowering ectopic fats accumulation notably in fatty liver as manifested in NAFLD and NASH.

Completed Development of Assay to Identify Clinically Active Cannabis Derived Compounds – Can-Fite accomplished the event of a organic cell-based in vitro assay which may determine clinically energetic hashish derived compounds that bind to and activate A3AR, the goal of Can-Fite’s platform expertise. In addition to utilizing this assay within the growth of its personal hashish derived compound-based therapeutics, Can-Fite plans to market the assay on a ‘fee for service’ foundation to researchers and different hashish firms worldwide.

“We are very pleased with the results of the IDMC’s interim analysis and recommendation for our Phase III psoriasis study. Piclidenoson has a clear value proposition in the psoriasis market we believe, based on its demonstrated safety and efficacy to date, and the benefit of being an oral drug among a growing number of injectable biologics. Oral drugs are cost effective and more convenient for the patient. Both of these factors are preferred by psoriasis patients based on a 2018 study published in an industry journal,” said Can-Fite CEO Dr. Pnina Fishman. “This quarter we anticipate enrolling the first COVID-19 patient in our U.S. FDA Phase II study. Piclidenoson’s anti-inflammatory and anti-viral properties make it a promising candidate in the fight against this pandemic. We are also very encouraged by the level of interest in Namodenoson in the treatment of NAFLD/NASH from the scientific and business communities.”

Financial Results

Revenues for the 9 months ended September 30, 2020 had been $0.61 million in contrast with $1.84 million for a similar interval of 2019. The lower in revenues was primarily as a result of recognition of a decrease portion of advance funds acquired underneath distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.

Research and growth bills for the 9 months ended September 30, 2020 had been $9.05 million in contrast with $7.01 million for a similar interval of 2019. Research and growth bills for the 9 months ended September 30, 2020 comprised primarily of bills related to the Phase II research for Namodenoson within the therapy of NASH and HCC, in addition to bills for ongoing Phase III research of Piclidenoson within the therapy of rheumatoid arthritis and psoriasis. The improve is primarily resulting from elevated prices related to the accelerating charge of absorption of sufferers for the Phase III medical trial of Piclidenoson for the therapy of rheumatoid arthritis and for psoriasis throughout this era.

General and administrative bills had been $2.14 million for the 9 months ended September 30, 2020 in comparison with $2.22 million for a similar interval in 2019. The lower is primarily resulting from a lower in skilled companies and journey bills which was partly offset by a rise in salaries and associated advantages and insurance coverage bills.

Financial bills, web for the 9 months ended September 30, 2020 was $0.22 million in comparison with $0.44 million for a similar interval in 2019. The lower in monetary bills, web is principally resulting from honest worth revaluation of the funding in Wize Pharma Inc’s shares which is classed underneath quick time period funding.

Can-Fite’s web loss for the 9 months ended September 30, 2020 was $10.81 million in contrast with a web lack of $7.84 million for a similar interval in 2019. As of September 30, 2020, Can-Fite had money and money equivalents of $10.22 million as in comparison with $2.69 million at December 31, 2019. The improve in money in the course of the 9 months ended September 30, 2020 is because of an mixture of $17.68 million web proceeds acquired by means of a warrant train transaction in January 2020, a public providing in February 2020, partial workouts in March, April and May 2020 of warrants issued within the February 2020 public providing, and a registered direct providing in June and July 2020 which was offset by web money utilized in working exercise of $10.16 million.

The Company’s consolidated monetary outcomes for the 9 months ended September 30, 2020 are offered in accordance with US GAAP Reporting Standards.

Conference Call

Management will host a convention name immediately, November 30, 2020 at 9:15 a.m. ET. Investors within the U.S. are invited to dial 877-423-9813. International buyers could dial 201-689-8573. The convention ID is 13713545. Investors may additionally take part through webcast: http://public.viavid.com/index.php?id=142533

A replay of the webcast can be archived on Can-Fite’s web site for a time period. 

CONSOLIDATED STATEMENTS OF BALANCE SHEETS

In 1000’s (aside from share and per share information)

 

 

September 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

 

 

Unaudited

 

 

Audited

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and money equivalents

 

$

10,222

 

 

$

2,697

 

Other receivable and pay as you go bills

 

 

2,961

 

 

 

4,383

 

Short-term funding

 

 

57

 

 

 

64

 

 

 

 

 

 

 

 

 

 

Total present belongings

 

 

13,240

 

 

 

7,144

 

 

 

 

 

 

 

 

 

 

NON-CURRENT ASSETS:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other non-current receivables

912

Operating lease proper of use belongings

 

 

58

 

 

 

82

 

Property, plant and tools, web

 

 

28

 

 

 

36

 

 

 

 

 

 

 

 

 

 

Total long-term belongings

 

 

86

 

 

 

1,030

 

 

 

 

 

 

 

 

 

 

Total belongings

 

$

13,326

 

 

$

8,174

 

 

CONSOLIDATED STATEMENTS OF BALANCE SHEETS

In 1000’s (aside from share and per share information)

 

 

September 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

 

 

Unaudited

 

 

Audited

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

 

 

 

 

 

 

 

Trade payables

 

$

784

 

 

$

2,156

 

Current maturity of working lease legal responsibility

 

 

34

 

 

 

36

 

Deferred revenues

 

 

603

 

 

 

469

 

Other accounts payable

 

 

398

 

 

 

610

 

 

 

 

 

 

 

 

 

 

Total present liabilities

 

 

1,819

 

 

 

3,271

 

 

 

 

 

 

 

 

 

 

NON-CURRENT LIABILITIES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Long-term working lease legal responsibility

 

 

15

 

 

 

39

 

Deferred revenues

 

 

1,951

 

 

 

2,422

 

 

 

 

 

 

 

 

 

 

Total long-term liabilities

 

 

1,966

 

 

 

2,461

 

 

 

 

 

 

 

 

 

 

CONTINGENT LIABILITIES AND COMMITMENTS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ordinary shares of NIS 0.25 par worth – Authorized: 500,000,000 shares at September 30, 2020 and December 31, 2019; Issued and excellent: 462,419,463 shares as of September 30, 2020; 120,652,683 shares as of December 31, 2019

 

 

32,936

 

 

 

8,225

 

Additional paid-in capital

 

 

97,314

 

 

 

103,401

 

Accumulated different complete revenue

 

 

1,127

 

 

 

1,127

 

Accumulated deficit

 

 

(121,836

)

 

 

(110,311

)

 

 

 

 

 

 

 

 

 

Total fairness

 

 

9,541

 

 

 

2,442

 

 

 

 

 

 

 

 

 

 

Total liabilities and fairness

 

$

13,326

 

 

$

8,174

 

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

In 1000’s (aside from share and per share information)

 

 

Nine months ended

September 30,

 

 

 

2020

 

 

2019

 

 

 

Unaudited

 

 

 

 

 

 

 

 

Revenues

 

$

613

 

 

$

1,840

 

 

 

 

 

 

 

 

 

 

Research and growth bills

 

 

(9,055

)

 

 

(7,016

)

General and administrative bills

 

 

(2,144

)

 

 

(2,220

)

 

 

 

 

 

 

 

Operating loss

 

 

(10,586

)

 

 

(7,396

)

 

 

 

 

 

 

 

 

 

Total monetary bills, web

 

 

(224

)

 

 

(445

)

 

 

 

 

 

 

 

 

 

Net loss

 

 

(10,810

)

 

 

(7,841

)

 

 

 

 

 

 

 

 

 

Total complete loss

 

 

(10,810

)

 

 

(7,841

)

 

 

 

 

 

 

 

 

 

Deemed dividend

 

 

(715

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributed to odd shareholders

 

$

(11,525

)

 

$

(7,841

)

 

 

 

 

 

 

 

 

 

Basic and diluted web loss per share

 

 

(0.03

)

 

 

(0.11

)

 

 

 

 

 

 

 

 

 

Weighted common variety of odd shares utilized in computing primary and diluted web loss per share

 

 

323,360,926

 

 

 

74,451,754

 

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is a sophisticated medical stage drug growth Company with a platform expertise that’s designed to handle multi-billion greenback markets within the therapy of most cancers, liver, inflammatory illness and COVID-19. The Company’s lead drug candidate, Piclidenoson, is at present in a Phase III trial for psoriasis and a Phase II examine within the therapy of average COVID-19. Can-Fite’s liver drug, Namodenoson, is headed right into a Phase III trial for hepatocellular carcinoma (HCC), the most typical type of liver most cancers, and efficiently achieved its main endpoint in a Phase II trial for the therapy of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation within the U.S. and Europe and Fast Track Designation as a second line therapy for HCC by the U.S. Food and Drug Administration. Namodenoson has additionally proven proof of idea to doubtlessly deal with different cancers together with colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has proven efficacy within the therapy of erectile dysfunction. These medication have a wonderful security profile with expertise in over 1,500 sufferers in medical research to this point. For extra info please go to: www.can-fite.com.

Forward-Looking Statements

This press launch could include forward-looking statements, about Can-Fite’s expectations, beliefs or intentions relating to, amongst different issues, market dangers and uncertainties, its product growth efforts, enterprise, monetary situation, outcomes of operations, methods or prospects. In addition, on occasion, Can-Fite or its representatives have made or could make forward-looking statements, orally or in writing. Forward-looking statements could be recognized by means of forward-looking phrases comparable to “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or different variations of those phrases or different comparable phrases or by the truth that these statements don’t relate strictly to historic or present issues. These forward-looking statements could also be included in, however usually are not restricted to, varied filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one in all Can-Fite’s licensed govt officers. Forward-looking statements relate to anticipated or anticipated occasions, actions, tendencies or outcomes as of the date they’re made. Because forward-looking statements relate to issues that haven’t but occurred, these statements are inherently topic to dangers and uncertainties that might trigger Can-Fite’s precise outcomes to vary materially from any future outcomes expressed or implied by the forward-looking statements. Many components might trigger Can-Fite’s precise actions or outcomes to vary materially from the actions and outcomes anticipated in such forward-looking statements. Factors that might trigger our precise outcomes to vary materially from these expressed or implied in such forward-looking statements embrace, however usually are not restricted to: our historical past of losses and wishes for added capital to fund our operations and our incapacity to acquire extra capital on acceptable phrases, or in any respect; uncertainties of money flows and incapacity to satisfy working capital wants; the impression of the COVID-19 pandemic; the initiation, timing, progress and outcomes of our preclinical research, medical trials and different product candidate growth efforts; our means to advance our product candidates into medical trials or to efficiently full our preclinical research or medical trials; our receipt of regulatory approvals for our product candidates, and the timing of different regulatory filings and approvals; the medical growth, commercialization and market acceptance of our product candidates; our means to ascertain and preserve strategic partnerships and different company collaborations; the implementation of our enterprise mannequin and strategic plans for our enterprise and product candidates; the scope of safety we’re in a position to set up and preserve for mental property rights masking our product candidates and our means to function our enterprise with out infringing the mental property rights of others; aggressive firms, applied sciences and our trade; statements as to the impression of the political and safety scenario in Israel on our enterprise; and dangers and different threat components detailed in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an trade sector the place securities values are extremely unstable and could also be influenced by financial and different components past its management. Can-Fite doesn’t undertake any obligation to publicly replace these forward-looking statements, whether or not because of new info, future occasions or in any other case.

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