CANF Can Fite BioPharma Ltd

Exhibit 99.1

 

OPERATING AND FINANCIAL REVIEW AND PROSPECTS

 

You should read the following selected financial data and discussion of our operating and financial condition and prospects in conjunction with the financial statements and the notes thereto included elsewhere in this 6-K and our Annual Report on Form 20-F for the year ended December 31, 2023 (the “Annual Report”). Our financial statements are prepared in accordance with U.S. GAAP, and reported in U.S. dollars. We maintain our accounting books and records in U.S. dollars and our functional currency is the U.S. dollar. Certain amounts presented herein may not sum due to rounding. Unless the context requires otherwise, references in this report to “Can-Fite,” the “Company,” “we,” “us” and “our” refer to Can-Fite BioPharma Ltd, an Israeli company and our consolidated subsidiaries. “NIS” means New Israeli Shekel, and “$,” “US$,“U.S. dollars” and “USD” mean United States dollars.

 

Forward Looking Statements

 

The following discussion contains “forward-looking statements,” including statements regarding expectations, beliefs, intentions or strategies for the future. These statements may identify important factors which could cause our actual results to differ materially from those indicated by the forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to:

 

	●	our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all;
	●	uncertainties of cash flows and inability to meet working capital needs;
	●	the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts;

 

●

our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials;

 

●

our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals;

 

●

the clinical development, commercialization and market acceptance of our product candidates;

 

●

our ability to establish and maintain strategic partnerships and other corporate collaborations;

 

●

the implementation of our business model and strategic plans for our business and product candidates;

 

●

the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others;

 

	●	competitive companies, technologies and our industry;
	●	risks related to the resurgence of the COVID-19 pandemic and the Russian invasion of Ukraine;
	●	risks related to not satisfying the continued listing requirements of NYSE American;

 

	●	statements as to the impact of the political, economic and security situation in Israel on our business, including due to the current war between Israel and Hamas; and
	●	those factors referred to under the headings “Risk Factors” and “Operating and Financial Review and Prospects” in our Annual Report, as well as in our Annual Report generally.

 

 

All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date of the 6-K to which this discussion is attached and are expressly qualified in their entirety by the cautionary statements included herein. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.

 

Glossary of Certain Terms

 

As used herein, unless the context otherwise requires:

 

●

references to “ADSs” refer to the Registrant’s American Depositary Shares;

 

●

references to “A3AR” refer to the A3 adenosine receptor;

 

●

references to “HCC” refer to hepatocellular carcinoma, also known as primary liver cancer; and

 

●

references to “ordinary shares,” “our shares” and similar expressions refer to the Company’s ordinary shares, no nominal (par) value per share.

 

Overview

 

We are a clinical-stage biopharmaceutical company that develops orally bioavailable small molecule therapeutic products for the treatment of cancer, liver and inflammatory diseases and erectile dysfunction. We are also developing specific formulations of cannabis components for the treatment of cancer, inflammatory, autoimmune, and metabolic diseases. Our platform technology utilizes the Gi protein associated A3 adenosine receptor, or A3AR, as a therapeutic target. A3AR is highly expressed in pathological body cells such as inflammatory and cancer cells, and has a low expression in normal cells, suggesting that the receptor could be a specific target for pharmacological intervention. Our pipeline of drug candidates are synthetic, highly specific agonists and allosteric modulators targeting the A3AR.

 

Our product pipeline is based on the research of Dr. Pnina Fishman, who investigated a clinical observation that tumor metastasis can be found in most body tissues, but are rarely found in muscle tissue, which constitutes approximately 60% of human body weight. Dr. Fishman’s research revealed that one reason that striated muscle tissue is resistant to tumor metastasis is that muscle cells release small molecules which bind with high selectivity to the A3AR. As part of her research, Dr. Fishman also discovered that A3ARs have significant expression in tumor and inflammatory cells, whereas normal cells have low or no expression of this receptor. The A3AR agonists and allosteric modulators, currently our pipeline of drug candidates, bind with high selectivity and affinity to the A3ARs and upon binding to the receptor initiate down-stream signal transduction pathways resulting in apoptosis, or programmed cell death, of tumors and inflammatory cells and to the inhibition of inflammatory cytokines. Cytokines are proteins produced by cells that interact with cells of the immune system in order to regulate the body’s response to disease and infection. Overproduction or inappropriate production of certain cytokines by the body can result in disease. In addition, our product candidateds also induce the production of positive cytokines such as granulocyte colony stimulating factor (G-CSF) and adiponectin which are responsible for the chemo-protective and liver-protective effects of the drugs on liver

 

Our product candidates, CF101, CF102 and CF602, are being developed to treat oncological and inflammatory diseases, as well as erectile dysfunction. CF101, also known as Piclidenoson, is in an advanced stage of clinical development for the treatment of psoriasis. CF102, also known as Namodenoson, is being developed for the treatment of HCC and has orphan drug designation for this indication in the United States and Europe. Namodenoson was granted Fast Track designation by the FDA for patients with advanced HCC. who failed first line treatment. Namodenoson is also being developed for the treatment of pancreatic cancer based on pre-clinical findings showing robust anti-pancreatic tumor growth and we have submitted an application to the FDA for orphan drug designation. Due to the liver protective effect of Namidenoson, it is also being developed for the treatment of NASH (also known as MASH). CF602 is our second generation allosteric drug candidate for the treatment of erectile dysfunction, which has shown efficacy in the treatment of erectile dysfunction in preclinical studies and we are investigating additional compounds, targeting A3AR, for the treatment of erectile dysfunction. Preclinical studies revealed that our drug candidates have potential to treat additional inflammatory diseases, such as Crohn’s disease, oncological diseases such as prostate cancer, viral diseases, such as the JC virus, obesity and Lowe Syndrome.

 

 

We believe our pipeline of drug candidates represent a significant market opportunity. For instance, according to iHealthcareAnalyst, the psoriasis drug market is forecasted to be worth $11.3 billion by 2025. According to DelveInsight, the HCC drug market in the G8 countries (U.S., Germany, France, Italy, Spain, UK, Japan and China) is expected to reach $3.8 billion by 2027. 

 

We have in-licensed an allosteric modulator of the A3AR, CF602 from Leiden University. In addition, we have out-licensed the following product candidates for indications that we are currently pursuing:

 

●

Piclidenoson for the treatment of (i) psoriasis to Cipher Pharmaceuticals, or Cipher, for Canada, (ii) psoriasis to Gebro Holding, or Gebro, for Spain, Switzerland and Austria, (iii) psoriasis to CMS Medical, or CMS, for China (including Hong Kong, Macao and Taiwan), (iv) psoriasis to Kyongbo Pharm Co. Ltd., or Kyongbo Pharm, for South Korea, (v) psoriasis to Ewopharma AG, or Ewopharma, for Central Eastern Europe, and (vi) osteoarthritis in companion animals including dogs and cats to Vetbiolix.

 

●

Namodenoson for the treatment of (i) liver cancer and MASH to Chong Kun Dang Pharmaceuticals, or CKD, for South Korea, (ii) advanced liver cancer and NAFLD/MASH to CMS for China (including Hong Kong, Macao and Taiwan), and (iii) HCC, MASH and pancreatic cancer to Ewopharma, for Central Eastern Europe and Switzerland.

 

Currently, (i) we are undertaking preparatory work for pivotal Phase III studies for Piclidenoson in the treatment of psoriasis following meetings with the FDA & EMA, which we expect to commence in the fourth quarter of 2024 (ii) we are conducting a pivotal Phase III trial for Namodenoson in the treatment of advanced liver cancer which is enrolling patients, (iii) we are conducting a Phase IIb study of Namodenoson in the treatment of MASH which is enrolling patients, (iv) we are undertaking preparatory work for a Phase IIa study with Namodenoson for the treatment of pancreatic cancer which we expect to commence in the third quarter of 2024, (v) we are investigating additional compounds, targeting the A3 adenosine receptor, for the treatment of erectile dysfunction, and (vi) we are conducting pre-clinical studies with formulations of cannabis components for the treatment of diseases in which there is an overexpression of A3AR. Since inception, we have incurred significant losses in connection with our research and development.

 

Moreover, we believe characteristics of Piclidenoson, as exhibited in our clinical studies to date, including its good safety profile, clinical activity, simple and less frequent delivery through oral administration and its low cost of production, position it well against the competition in psoriasis markets, where treatments, when available, often include injectable drugs, many of which can be highly toxic, expensive and not always effective.

 

Like Piclidenoson, Namodenoson has a good safety profile, is orally administered and has a low cost of goods, which we believe may position it well in the HCC market, where no drug has yet been approved by the FDA for patients with advanced liver cancer disease defined as Child Pugh B7. In addition, pre-clinical studies show Namodenoson’s novel mechanism of action which entails de-regulation of three key signaling pathways which mediate the etiology and pathology of NAFLD/MASH and are responsible for the anti-inflammatory, anti-steatotic and anti-fibrotic effect in the liver. Most recently, pre-clinical data support Piclidenoson’s potential utilization for the treatment of Lowe Syndrome and Namodenoson’s potential utilization as an anti-obesity drug.

 

Nevertheless, other drugs on the market, new drugs under development (including drugs that are in more advanced stages of development in comparison to our drug candidates) and additional drugs that were originally intended for other purposes, but were found effective for purposes targeted by us, may all be competitive to the current drugs in our pipeline. In fact, some of these drugs are well established and accepted among patients and physicians in their respective markets, are orally bioavailable, can be efficiently produced and marketed, and are relatively safe. None of our product candidates have been approved for sale or marketing and, to date, there have been no commercial sales of any of our product candidates.

 

Since inception, we have incurred significant losses in connection with our research and development. As of June 30, 2024, we had an accumulated deficit of approximately $162.44 million. Although we have recognized revenues in connection with our existing out-licensing agreements with, Cipher, CKD, Gebro and Ewopharma, and our historic out-licensing agreement with KD, CMS, Kyongbo and Seikagaku Corporation, or SKK, we expect to generate losses in connection with the research and development activities relating to our pipeline of drug candidates. Such research and development activities are budgeted to expand over time and will require further resources if we are to be successful. As a result, we expect to incur operating losses, which may be substantial over the next several years, and we will need to obtain additional funds to further develop or research and development programs.

 

 

We have funded our operations primarily through the sale of equity securities (both in private placements and in public offerings) and payments received under our existing out-licensing agreements with KD, Cipher, CKD Gebro, CMS, and Kyongbo and our historic out-licensing agreement with SKK. We expect to continue to fund our operations over the next several years through our existing cash resources, potential future milestone payments that we expect to receive from our licensees, interest earned on our investments, if any, and additional capital to be raised through public or private equity offerings or debt financings. As of June 30, 2024, we had approximately $4.72 million of cash, cash equivalents and short-term deposits, which does not include the approximately $5.0 million in gross proceeds (approximately $4.47 million net of issuance costs) from a warrant repricing transaction in August 2024. A substantial part of this amount is designated for payments to be made in relation to support the Company’s clinical trials.

  

Results of Operations

 

Revenues 

 

Revenues for the six months ended June 30, 2024 were $0.32 million compared to revenues of $0.39 million for the same period in 2023. Revenues for the six months ended June 30, 2024 and June 30, 2023 comprised of recognition of a portion of advance payments received under distribution agreements with Gebro, CKD, Cipher and Ewopharma.

 

Research and development expenses

 

Research and development expenses for the six months ended June 30, 2024 were $2.89 million compared with $3.42 million for the same period in 2023. Research and development expenses for the first half of 2024 comprised primarily of expenses associated with the two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase IIb study for NASH. The decrease is primarily due to a decrease in expenses associated with Piclidenoson.

 

General and administrative expenses

 

General and administrative expenses were $1.53 million for the six months ended June 30, 2024 compared to $1.47 million for the same period in 2023. The decrease is primarily due to the decrease in our D&O insurance policy and decrease in bonus expenses to employees and executives. We expect that general and administrative expenses will remain at the same level through 2024.

 

Financial income, net

 

Financial income, net for the six months ended June 30, 2024 was $0.14 million compared to $0.28 million for the same period in 2023. The decrease in financial income, net was mainly due to lower income on short term deposits.  

 

Liquidity and Capital Resources

 

Since inception, we have funded our operations primarily through public (in Israel and US) and private offerings of our equity securities and payments received under our strategic licensing arrangements. As of June 30, 2024, we had approximately $4.72 million in cash, cash equivalents and short-term deposits, and have invested most of our available cash funds in ongoing cash accounts. During August 2024, we raised $5 million in gross proceeds from the exercise of certain outstanding warrants.

 

Under Accounting Standard Codification (“ASC”) Subtopic 205-40, Presentation of Financial Statements—Going Concern (“ASC 205-40”), the Company has the responsibility to evaluate whether conditions and/or events raise substantial doubt about its ability to meet its obligations as they become due within one year after the date that the financial statements are issued. As required under ASC 205-40, management’s evaluation should initially not take into consideration the potential mitigating effects of management’s plans that have not been fully implemented as of the date the financial statements are issued.

 

 

Net cash used in operating activities was $4.04 million for the six months ended June 30, 2024, compared with net cash used in operating activities of $5.05 million for the same period in 2023. The $1.01 million decrease in the net cash used in operating activities during the six months ended June 30, 2024 compared to the same period in 2023, was mainly due to higher costs in 2023 due to completion of the Phase III study of Piclidenoson for the treatment of psoriasis in during 2023.

 

Net cash provided by investing activities for the six months ended June 30, 2024 was $4.5 million compared with net cash used in investing activities of $1.0 million for the same period in 2023. The $5.5 million increase in the net cash provided by investing activities during the six months ended June 30, 2024 compared to the same period in 2023, was mainly due to maturity in short term deposit.

 

There as no net cash provided by financing activities for the six months ended June 30, 2024 compared to $6.53 million net cash provided by financing activities for the same period in 2023. Net cash provided by financing activities for the six months ended June 30, 2023 was due to proceeds from issuance of share capital and warrants, while no such activity in 2024.

 

Developing drugs, conducting clinical trials and commercializing products is expensive and we will need to raise substantial additional funds to achieve our strategic objectives. Although we believe our existing financial resources as of the date of issuance of this Form 6-K, will be sufficient to fund our projected cash requirements at least through the next twelve months, we will require significant additional financing to fund our operations. Additional financing may not be available on acceptable terms, if at all. Our future capital requirements will depend on many factors, including:

 

	●	the level of research and development investment required to develop our product candidates;
	●	the failure to obtain regulatory approval or achieve commercial success of our product candidates, including Piclidenoson, Namodenoson and CF602;

 

●

the results of our preclinical studies and clinical trials for our earlier stage product candidates, and any decisions to initiate clinical trials if supported by the preclinical results;

 

●

the costs, timing and outcome of regulatory review of our product candidates that progress to clinical trials;

 

	●	our ability to partner or sub-license any of our product candidates;
	●	the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our issued patents and defending intellectual property-related claims;

 

●

the cost of commercialization activities if any of our product candidates are approved for sale, including marketing, sales and distribution costs;

 

●

the cost of manufacturing our product candidates and any products we successfully commercialize;

 

●

the timing, receipt and amount of sales of, or royalties on, our future products, if any;

 

●

the expenses needed to attract and retain skilled personnel;

 

●

any product liability or other lawsuits related to our products;

 

●

the extent to which we acquire or invest in businesses, products or technologies and other strategic relationships;

 

	●	the costs of financing unanticipated working capital requirements and responding to competitive pressures;
	●	maintaining minimum shareholders’ equity requirements and complying with other continue listing standards under the NYSE American Company Guide; and

 

●

the impact of the COVID-19 outbreak, the Russian invasion of Ukraine and the war between Israel and Hamas, which may exacerbate the magnitude of the factors discussed above.

 

 

Until we can generate significant continuing revenues, we expect to satisfy our future cash needs through payments received under our license agreements, debt or equity financings, or by out-licensing other product candidates. We cannot be certain that additional funding will be available to us on acceptable terms, or at all. If funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs or our commercialization efforts.

 

Research and Development, Patents and Licenses, Etc.

 

Our research and development expenses consist primarily of salaries and related personnel expenses, fees paid to external service providers, up-front and milestone payments under our license agreements, patent-related legal fees, costs of preclinical studies and clinical trials, drug and laboratory supplies and costs for facilities and equipment. We charge all research and development expenses to operations as they are incurred. We expect our research and development expense to remain our primary expense in the near future as we continue to develop our products. Increases or decreases in research and development expenditures are attributable to the number and/or duration of the pre-clinical and clinical studies that we conduct.

 

The following table identifies our current major research and development projects:

 

Project		Status		Expected or Recent Near Term Milestone
Piclidenoson		COMFORT Phase III study in psoriasis		Commencement of pivotal Phase III studies following meetings with FDA & EMA expected in the fourth quarter of 2024.
Namodenoson		Phase III in HCC		Enrolling patients
		Phase IIb study in NASH		Enrolling patients
		Phase IIa study in pancreatic cancer		Phase IIa study expected to commence in the third quarter 2024

 

We record certain costs for each development project on a “direct cost” basis, as they are recorded to the project for which such costs are incurred. Such costs include, but are not limited to, CRO expenses, drug production for pre-clinical and clinical studies and other pre-clinical and clinical expenses. However, certain other costs, including but not limited to, salary expenses (including salaries for research and development personnel), facilities, depreciation, share-based compensation and other overhead costs are recorded on an “indirect cost” basis, i.e., they are shared among all of our projects and are not recorded to the project for which such costs are incurred. We do not allocate direct salaries to projects due to the fact that our project managers are generally involved in several projects at different stages of development, and the related salary expense is not significant to the overall cost of the applicable projects. In addition, indirect labor costs relating to our support of the research and development process, such as manufacturing, controls, pre-clinical analysis, laboratory testing and initial drug sample production, as well as rent and other administrative overhead costs, are shared by many different projects and have never been considered by management to be of significance in its decision-making process with respect to any specific project. Accordingly, such costs have not been specifically allocated to individual projects. 

 

Set forth below is a summary of the gross direct costs allocated to our main projects on an individual basis, as well as the gross direct costs allocated to our less significant projects on an aggregate basis, for the years ended December 31, 2021, 2022 and 2023 and for the six months ended June 30, 2024 and on an aggregate basis since project inception:

 

		($ in thousands)												Six Months Ended				Costs Since
		Year Ended December 31,												June 30,				Project
		2021				2022				2023				2024				Inception
Piclidenoson			4,041				2,790				1,471				353				48,411
Namodenoson			3,991				3,383				2,989				1,828				24,227
CF602			31				6				-				-				1,740
Other projects			-				-				-				-				4,129
Total gross direct project costs (1)			8,063				6,179				4,460				2,181				78,507

 

(1)	Does not include indirect project costs and overhead, such as payroll and related expenses (including stock-based compensation), facilities, depreciation and impairment of intellectual property, which are included in total research and development expenses in our financial statements.

 

 

From our inception through June 30, 2024, we have incurred research and development expenses of approximately $149.08 million. We expect that a large percentage of our research and development expense in the future will be incurred in support of our current and future preclinical and clinical development projects. Due to the inherently unpredictable nature of preclinical and clinical development processes and given the early stage of our preclinical product development projects, we are unable to estimate with any certainty the costs we will incur in the continued development of the product candidates in our pipeline for potential commercialization. Clinical development timelines, the probability of success and development costs can differ materially from expectations. We expect to continue to test our product candidates in preclinical studies for toxicology, safety and efficacy, and to conduct additional clinical trials for each product candidate. If we are not able to enter into an out-licensing arrangement with respect to any product candidate prior to the commencement of later stage clinical trials, we may fund the trials for the product candidates ourselves.

 

While we are currently focused on advancing each of our product development projects, our future research and development expenses will depend on the clinical success of each product candidate, as well as ongoing assessments of each product candidate’s commercial potential. In addition, we cannot forecast with any degree of certainty which product candidates may be subject to future out-licensing arrangements, when such out-licensing arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements. 

 

As we obtain results from clinical trials, we may elect to discontinue or delay clinical trials for certain product candidates or projects in order to focus our resources on more promising product candidates or projects. Completion of clinical trials by us or our licensees may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a product candidate.

 

The cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical development, including, among others:

 

●

the number of sites included in the clinical trials;

 

●

the length of time required to enroll suitable patients;

 

●

the number of patients that participate in the clinical trials;

 

●

the duration of patient follow-up;

 

●

the development stage of the product candidate; and

 

●

the efficacy and safety profile of the product candidate.

 

We expect our research and development expenses to increase in the future from current levels as we continue the advancement of our clinical trials and preclinical product development and to the extent we in-license new product candidates. The lengthy process of completing clinical trials and seeking regulatory approval for our product candidates requires expenditure of substantial resources. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Because of the factors set forth above, we are not able to estimate with any certainty when we would recognize any net cash inflows from our projects.

 

Trend Information.

 

We are a development stage company and it is not possible for us to predict with any degree of accuracy the outcome of our research, development or commercialization efforts. As such, it is not possible for us to predict with any degree of accuracy any significant trends, uncertainties, demands, commitments or events that are reasonably likely to have a material effect on our net sales or revenues, income from continuing operations, profitability, liquidity or capital resources, or that would cause financial information to not necessarily be indicative of future operating results or financial condition. However, to the extent possible, certain trends, uncertainties, demands, commitments and events are identified in the preceding subsections.

 

Off-Balance Sheet Arrangements.

 

We have no off-balance sheet arrangements that have had or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors. 

 

 

7

Exhibit 99.3

 

Can-Fite Reports First Half 2024 Financial Results & Progress in Two
Pivotal Phase III Clinical Studies

 

RAMAT GAN, Israel, Aug. 29, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results and clinical updates for H1 2024.

 

H1 2024 Highlights

 

1.

Exercise of Warrants for Approximately $5.0 Million in Gross Proceeds – in August, the Company announced the exercise of certain outstanding warrants to purchase up to an aggregate of 2,857,143 American Depositary Shares (ADSs), having an exercise price of $1.75 per ADS, issued by Can-Fite in January 2023 and November 2023. In consideration for the immediate exercise of the warrants for cash, the Company issued new unregistered warrants to purchase up to 5,714,286 ADSs.

 

2.

Piclidenoson Drug Candidate -

 

Positive Results from an Osteoarthritis clinical study in dogs were reported by Can-Fite’s partner Vetbiolix, who is developing Piclidenoson for veterinary indications. Vetbiolix concluded successfully the study interim analysis and can now exercise an option to enter into a full in license agreement with Can-Fite. Based on the agreement between the two companies, if it exercises the option, Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval.

 

3.

Namodenoson Drug Candidate -

 

Liver Cancer - the Company’s Phase 3 pivotal study now has 31 recruiting medical centers in Europe, Israel and the US. Namodenoson has Orphan Drug status with both the U.S. Food and Drug Administration (FDA) and European Medicines Agency, as well as Fast Track Status with the FDA. A compassionate use program has also been ongoing in Israel and Romania. In addition, two scientific articles, one describing long-term complete response to Namodenoson in a patient with advanced liver cancer and the other presents Namodenoson as a promising drug candidate to treat advanced liver cancer and MASH, were published.

 

Pancreatic Cancer – the Company received approval from the Institutional Review Board (IRB) of Rabin Medical Center, a leading medical institution in Israel, for a Phase IIa study for the treatment of pancreatic cancer. The Company awaits now the approval of the Ministry of Health (MOH). In addition, the Company submitted an application to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for Namodenoson in the treatment of pancreatic carcinoma.

 

MASH (metabolic dysfunction-associated steatohepatitis) – the FDA granted IND clearance for Namodenoson to treat MASH patients in a Phase IIb study. Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and the IND approval by FDA allows for the recruitment of patients in the US.

 

“With two drugs in advanced clinical studies we continue to enroll patients and push forward towards a positive conclusion of each program. We continue to position our drugs for multi-billion markets with unmet needs,” stated Can-Fite CEO & CFO Motti Farbstein.

 

 

Financial Results

 

Revenues for the six months ended June 30, 2024 were $0.32 million compared to revenues of $0.39 million for the same period in 2023. Revenues for the six months ended June 30, 2024 and June 30, 2023 comprised of recognition of a portion of advance payments received under distribution agreements with Gebro, CKD, Cipher and Ewopharma.

 

Research and development expenses for the six months ended June 30, 2024 were $2.89 million compared with $3.42 million for the same period in 2023. Research and development expenses for the first half of 2024 comprised primarily of expenses associated with the two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for NASH. The decrease is primarily due to a decrease in expenses associated with Piclidenoson.

 

General and administrative expenses were $1.53 million for the six months ended June 30, 2024 compared to $1.47 million for the same period in 2023. The decrease is primarily due to the decrease in our D&O insurance policy and decrease in bonus expenses to employees and executives. We expect that general and administrative expenses will remain at the same level through 2024.

 

Financial income, net for the six months ended June 30, 2024 was $0.14 million compared to $0.28 million for the same period in 2023. The decrease in financial income, net was mainly due to lower income on short term deposits.  

 

Net loss for the six months ended June 30, 2024 was $3.95 million compared with a net loss of $4.22 million for the same period in 2023. The decrease in net loss for the six months ended June 30, 2024 was primarily attributable to the decrease in our operating expenses.

 

As of June 30, 2024, Can-Fite had cash and cash equivalents and short term deposits of $4.72 million as compared to $8.90 million at December 31, 2023. The decrease in cash during the six months ended June 30, 2024 is due to the ongoing operations of the Company. On August 8, 2024, the Company and a certain warrant holder entered into an inducement offer letter agreement, according to which the warrant holder agreed to exercise for cash warrants to purchase 2,857,143 ADSs at an exercise price of $1.75 per ADS. Total gross consideration received was $5 million. In addition, as part of the inducement letter and the exercise of warrants, the Company has issued the investor new warrants exercisable into 5,714,286 ADSs at an exercise price of $2.25 per ADS. Moreover, the Company also issued to its placement agent new warrants exercisable into 200,000 ADSs at an exercise price of $2.1875 per ADS.

 

The Company’s condensed consolidated financial results for the six months ended June 30, 2024 are presented in accordance with US GAAP Reporting Standards.

 

 

CONDENSED CONSOLIDATED BALANCE SHEETS

U.S dollars in thousands (except for share and per share data)

 

		June 30,				December 31,
		2024				2023
		Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	4,719			$	4,278
Short term deposits			-				4,625
Prepaid expenses and other current assets			1,100				986
Short-term investment			9				19
Total current assets			5,828				9,908
NON-CURRENT ASSETS:
Operating lease right of use assets			62				52
Property, plant and equipment, net			32				29
Total non-current assets			94				81
Total assets		$	5,922			$	9,989

 

 

CONDENSED CONSOLIDATED BALANCE SHEETS

U.S dollars in thousands (except for share and per share data)

 

		June 30,				December 31,
		2024				2023
		Unaudited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables		$	885			$	427
Current maturity of operating lease liability			36				27
Deferred revenues			636				622
Other accounts payable			430				944
Total current liabilities			1,987				2,020
NON-CURRENT LIABILITIES:
Long - term operating lease liability			21				13
Deferred revenues			1,435				1,713
Total long-term liabilities			1,456				1,726
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of no-par value - Authorized: 5,000,000,000 shares at June 30, 2024 and December 31, 2023; Issued and outstanding: 1,671,728,493 and 1,359,837,393 shares as of June 30, 2024 and December 31, 2023, respectively			-				-
Additional paid-in capital			163,790				163,597
Accumulated other comprehensive income			1,127				1,127
Accumulated deficit			(162,438	)			(158,481	)
Total shareholders’ equity			2,479				6,243
Total liabilities and shareholders’ equity		$	5,922			$	9,989

 

 

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

U.S dollars in thousands (except for share and per share data)

 

		Six months ended June 30,
		2024				2023
		Unaudited
Revenues		$	316			$	392
Research and development expenses			(2,885	)			(3,417	)
General and administrative expenses			(1,525	)			(1,471	)
Operating loss			(4,094	)			(4,496	)
Financial income, net			137				276
Comprehensive loss			(3,957	)			(4,220	)
Basic and diluted net loss per share			(0.00	)			(0.00	)
Weighted average number of ordinary shares used in computing basic and diluted net loss per share			1,821,304,184				1,202,110,110

 

About Can-Fite BioPharma Ltd.

 

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment metabolic dysfunction-associated steatohepatitis (MASH), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com.

 

 

Forward-Looking Statements

 

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward-looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

 

Contact

 

Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114

 

v3.24.2.u1

Document And Entity Information	6 Months Ended
	Jun. 30, 2024
Document Information Line Items
Entity Registrant Name	CAN-FITE BIOPHARMA LTD.
Document Type	6-K
Current Fiscal Year End Date	--12-31
Amendment Flag	false
Entity Central Index Key	0001536196
Document Period End Date	Jun. 30, 2024
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q2

v3.24.2.u1

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Jun. 30, 2024	Dec. 31, 2023
CURRENT ASSETS:
Cash and cash equivalents	$ 4,719	$ 4,278
Short term deposits		4,625
Prepaid expenses and other current assets	1,100	986
Short-term investment	9	19
Total current assets	5,828	9,908
NON-CURRENT ASSETS:
Operating lease right of use assets	62	52
Property, plant and equipment, net	32	29
Total non-current assets	94	81
Total assets	5,922	9,989
CURRENT LIABILITIES:
Trade payables	885	427
Current maturity of operating lease liability	36	27
Deferred revenues	636	622
Other accounts payable	430	944
Total current liabilities	1,987	2,020
NON-CURRENT LIABILITIES:
Operating lease liability	21	13
Deferred revenues	1,435	1,713
Total long-term liabilities	1,456	1,726
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of no-par value - Authorized: 5,000,000,000 shares at June 30, 2024 and December 31, 2023; Issued and outstanding: 1,671,728,493 and 1,359,837,393 shares as of June 30, 2024 and December 31, 2023, respectively
Additional paid-in capital	163,790	163,597
Accumulated other comprehensive income	1,127	1,127
Accumulated deficit	(162,438)	(158,481)
Total shareholders’ equity	2,479	6,243
Total liabilities and shareholders’ equity	$ 5,922	$ 9,989

v3.24.2.u1

Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares	Jun. 30, 2024	Dec. 31, 2023
Statement of Financial Position [Abstract]
Ordinary shares, par value (in Dollars per share)
Ordinary shares, shares authorized	5,000,000,000	5,000,000,000
Ordinary shares, shares issued	1,671,728,493	1,359,837,393
Ordinary shares, shares outstanding	1,671,728,493	1,359,837,393

v3.24.2.u1

Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands		6 Months Ended
		Jun. 30, 2024	Jun. 30, 2023
Income Statement [Abstract]
Revenues		$ 316	$ 392
Research and development expenses		(2,885)	(3,417)
General and administrative expenses		(1,525)	(1,471)
Operating loss		(4,094)	(4,496)
Financial income, net		137	276
Comprehensive loss		$ (3,957)	$ (4,220)
Basic net loss per share (in Dollars per share)		$ 0	$ 0
Weighted average number of ordinary shares used in computing basic net loss per share (in Shares)	[1]	1,821,304,184	1,202,110,110
[1] Including ordinary shares held in abeyance.

v3.24.2.u1

Condensed Consolidated Statements of Comprehensive Loss (Unaudited) (Parentheticals) - $ / shares		6 Months Ended
		Jun. 30, 2024	Jun. 30, 2023
Income Statement [Abstract]
Diluted net loss per share		$ 0.00	$ 0.00
Weighted average number of ordinary shares used in computing diluted net loss per share	[1]	1,821,304,184	1,202,110,110
[1] Including ordinary shares held in abeyance.

v3.24.2.u1

Condensed Consolidated Statements of Changes In Equity (Unaudited) - USD ($) $ in Thousands	Ordinary shares	Additional paid-in capital	Accumulated other comprehensive Income	Accumulated deficit	Total
Balance at Dec. 31, 2022		$ 154,192	$ 1,127	$ (150,847)	$ 4,472
Balance (in Shares) at Dec. 31, 2022	815,746,293
Comprehensive loss				(4,220)	(4,220)
Issuance of ordinary shares and warrants, net of issuance costs of $ 978		6,526			6,526
Issuance of ordinary shares and warrants, net of issuance costs of $ 978 (in Shares)	90,000,000
Issuance of ordinary shares due to exercise of pre-funded warrants		1			1
Issuance of ordinary shares due to exercise of pre-funded warrants (in Shares)	319,091,100
Share-based payments		95			95
Balance at Jun. 30, 2023		160,814	1,127	(155,067)	6,874
Balance (in Shares) at Jun. 30, 2023	1,224,837,393
Balance at Dec. 31, 2023		163,597	1,127	(158,481)	$ 6,243
Balance (in Shares) at Dec. 31, 2023	1,359,837,393				1,359,837,393
Comprehensive loss				(3,957)	$ (3,957)
Release of ordinary shares that were previously held in abeyance (refer to note 4)
Release of ordinary shares that were previously held in abeyance (refer to note 4) (in Shares)	296,891,100				296,891,100
Share-based payments		193			$ 193
Share-based payments (in Shares)	15,000,000
Balance at Jun. 30, 2024		$ 163,790	$ 1,127	$ (162,438)	$ 2,479
Balance (in Shares) at Jun. 30, 2024	1,671,728,493				1,671,728,493

v3.24.2.u1

Condensed Consolidated Statements of Changes In Equity (Unaudited) (Parentheticals) $ in Thousands	6 Months Ended
	Jun. 30, 2023 USD ($)
Statement of Stockholders' Equity [Abstract]
Net of issuance costs	$ 978

v3.24.2.u1

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023
Cash flows from operating activities:
Net loss	$ (3,957)	$ (4,220)
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation of property, plant and equipment	1	8
Reduction in the carrying amount of operating lease right of use asset	23	28
Share-based payments	193	95
Changes in fair value of short-term investment	10	(3)
Financial expenses (income), net	144	(146)
Change in prepaid expenses, and other current assets	(114)	(123)
Decrease in operating lease liability	(16)	(27)
Increase (decrease) in trade payables	458	(86)
Decrease in deferred revenues	(264)	(392)
Decrease in other accounts payable	(514)	(179)
Net cash used in operating activities	(4,036)	(5,045)
Cash flows from investing activities:
Purchase of property, plant and equipment	(4)	(2)
Maturity (investment) in short term deposits, net	4,500	(1,000)
Net cash used in investing activities	4,496	(1,002)
Cash flows from financing activities:
Proceeds from issuance of ordinary shares and warrants, net of issuance costs		6,526
Proceeds from issuance of ordinary share due to exercise of pre-funded warrants		1
Net cash provided by financing activities		6,527
Exchange differences on balances of cash and cash equivalents	(19)		[1]
Increase in cash and cash equivalents	441	480
Cash and cash equivalents at the beginning of the period	4,278	2,978
Cash and cash equivalents at the end of the period	4,719	3,458
Supplemental disclosures of noncash investing and financing activities:
Lease liabilities arising from obtaining right-of-use-assets	$ 14	$ 32
[1] Represent an amount of lower than $1.

v3.24.2.u1

General	6 Months Ended
	Jun. 30, 2024
General [Abstract]
GENERAL	NOTE 1:- GENERAL     a. Can-Fite Biopharma Ltd. (the “Company”) was incorporated and started to operate in September 1994 as a private Israeli company. Can-Fite is a clinical-stage biopharmaceutical company focused on developing orally bioavailable small molecule therapeutic products for the treatment of psoriasis, liver cancer, NASH and erectile dysfunction. Its platform technology utilizes the Gi protein associated A3AR as a therapeutic target. A3AR is highly expressed in patholological body cells such as inflammatory and cancer cells, and has a low expression in normal cells, suggesting that the receptor could be a specific target for pharmacological intervention. The Company’s pipeline of drug candidates are synthetic, highly specific agonists and allosteric modulators at the A3AR.   The Company’s ordinary shares have been publicly traded on the Tel-Aviv Stock Exchange since October 2005 under the symbol “CFBI” and the Company’s American Depositary Shares (“ADSs”) began public trading on the over the counter market in the U.S. in October 2012 and since November 2013 the Company’s ADSs have been publicly traded on the NYSE American under the symbol “CANF”. Each ADS represents 300 ordinary shares of the Company.   b. Under Accounting Standard Codification (“ASC”) Subtopic 205-40, Presentation of Financial Statements—Going Concern (“ASC 205-40”), the Company has the responsibility to evaluate whether conditions and/or events raise substantial doubt about its ability to meet its obligations as they become due within one year after the date that the financial statements are issued. As required under ASC 205-40, management’s evaluation should initially not take into consideration the potential mitigating effects of management’s plans that have not been fully implemented as of the date the financial statements are issued. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern.   Evaluation of Substantial Doubt Raised   In performing the first step of the evaluation, the Company concluded that the following conditions raised substantial doubt about its ability to continue as a going concern:   ● History of net losses of $3,957 and $4,220 for the six months ended June 30, 2024 and 2023, respectively.   ● Net operating cash outflow of $4,036 and $5,045 for the six months ended June 30, 2024 and 2023, respectively.   ● Reliance on additional financing in order to execute its research and development plans.   Consideration of Management’s Plans   In performing the second step of this assessment, the Company is required to evaluate whether it is probable that the Company’s plans will be effectively implemented within one year after the financial statements are issued and whether it is probable those plans will alleviate the substantial doubt raised about the Company’s ability to continue as a going concern. As of June 30, 2024, the Company had $4,719 in available cash and cash equivalents.   The Company is prepared to implement the following actions as required by business and market conditions: reducing non-essential expenses to conserve cash and improve its liquidity position, deferral and reprioritization of certain research and development programs that would involve reduced program spend until additional financing will be obtained in order to strengthen liquidity and to preserve key research and development, commercial and functional roles.   On August 8, 2024, subsequent to the balance sheet date, the Company entered into an inducement letter with an existing investor, according to which 857,142,900 warrants were exercised to ordinary shares for total consideration of $4,474 net of issuance costs. Refer to note 5 for additional information.   Management Assessment of Ability to Continue as a Going Concern   The Company has a history of operating losses and negative cash flows from operations. However, despite these conditions, the Company believes management’s plans, as described more fully above, will provide sufficient liquidity to meet its financial obligations.   Therefore, management concluded these plans alleviate the substantial doubt that was raised about the Company’s ability to continue as a going concern for at least twelve months from the date that the consolidated financial statements were issued.    Future Plans and Considerations   Although not considered for purposes of the Company’s assessment of whether substantial doubt was alleviated, the Company has plans to improve operating cash flows by entering into strategic partnerships with other companies that can provide access to additional customers and new markets. The Company may also seek to raise additional funds through the issuance of debt and/or equity securities or otherwise.   The Company’s plans are subject to inherent risks and uncertainties. Accordingly, there can be no assurance that the Company’s plans can be effectively implemented and, therefore, that the conditions can be effectively mitigated.   Until such time, if ever, that the Company can generate revenue sufficient to achieve profitability, the Company expects to finance its operations through equity or debt financings, which may not be available to the Company on the timing needed or on terms that the Company deems to be favorable. To the extent that the Company raises additional capital through the sale of equity or debt securities, the ownership interest of its stockholders will be diluted. If the Company is unable to maintain sufficient financial resources, its business, financial condition and results of operations will be materially and adversely affected.   c. Basis of Presentation:   These unaudited Condensed consolidated financial statements have been prepared as of June 30, 2024 and for the six months period then ended. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been omitted. These unaudited Condensed consolidated financial statements should be read in conjunction with the audited financial statements and the accompanying notes of the Company for the year ended December 31, 2023 that are included in the Company’s Annual Report on Form 20-F, filed with the Securities and Exchange Commission on March 28, 2024 (the “Annual Report on Form 20-F”). The results of operations presented are not necessarily indicative of the results to be expected for the year ending December 31, 2024.   The significant accounting policies that have been applied in the preparation of the unaudited consolidated Condensed financial statements are identical to those that were applied in preparation of the Company’s most recent annual financial statements for the year ended December 31, 2023 included in the Annual Report on Form 20-F.   d. Revenue Recognition – Contract Balances   Contract liabilities include amounts received from customers for which revenue has not yet been recognized. Contract liabilities amounted to $2,071 and $2,335 as of June 30, 2024 and December 31, 2023, respectively and are presented under deferred revenues. During the six-month period ended June 30, 2024, the Company recognized revenues in the amount of $316 which have been included in the contract liabilities at December 31, 2023.

v3.24.2.u1

Fair Value Measurements	6 Months Ended
	Jun. 30, 2024
Fair Value Measurements [Abstract]
FAIR VALUE MEASUREMENTS	NOTE 2:- FAIR VALUE MEASUREMENTS   In accordance with ASC 820 “Fair Value Measurements and Disclosures”, the Company measures its short-term investment at fair value. Short-term investments are classified within Level 1 as the valuation inputs are valuations based on quoted prices in active markets for identical assets that the Company has the ability to access. The company’s short-term investment consists of an equity investment in a publicly traded company.   The Company’s financial assets and liabilities measured at fair value on a recurring basis, consisted of the following types of instruments as of the following dates: instruments as of the following dates:       June 30, 2024       Fair value measurements                             Description     Fair value       Level 1       Level 2       Level 3                                     Short-term investment   $ 9     $ 9     $ -     $ -         December 31, 2023       Fair value measurements   Description     Fair value       Level 1       Level 2       Level 3                                     Short-term investment   $ 19     $ 19     $ -     $ -

v3.24.2.u1

Earning Per Share	6 Months Ended
	Jun. 30, 2024
Earning Per Share [Abstract]
EARNING PER SHARE	NOTE 3:- EARNING PER SHARE   Basic and diluted net loss per share is calculated based on the weighted average number of ordinary shares outstanding during each period. Diluted net loss per share is calculated based on the weighted average number of ordinary shares outstanding during each year, plus dilutive potential in accordance with ASC 260, “Earnings per Share”.   The following table sets forth the computation of basic and diluted net loss per share for the periods presented:       Six month ended June 30,       2024     2023                 Numerator:             Net loss applicable to shareholders of Ordinary Shares   $ (3,957 )   $ (4,220 )                   Denominator:                 Weighted average shares used in computing basic and diluted net loss per share *)     1,821,304,184       1,202,110,110   Net loss per share of Ordinary Share, basic and diluted   $ (0.00 )   $ (0.00 )   *) Including ordinary shares held in abeyance.   All outstanding share options and warrants (except for prefunded warrants) for the period ended June 30, 2024 and 2023 have been excluded from the calculation of the diluted net loss per share, because all such securities are anti-dilutive for all periods presented.   The potential shares of ordinary shares that were excluded from the computation of diluted net loss per share attributable to ordinary shareholders for the periods presented because including them would have been anti-dilutive are as follows:       Six month ended June 30,       2024     2023                 Options     86,064,500       42,477,000                     Warrants     1,851,518,298       1,222,016,340                     Total     1,937,582,798       1,264,493,340

v3.24.2.u1

Contingent Liabilities and Commitments	6 Months Ended
	Jun. 30, 2024
Contingent Liabilities and Commitments [Abstract]
CONTINGENT LIABILITIES AND COMMITMENTS	NOTE 4:- CONTINGENT LIABILITIES AND COMMITMENTS   According to the patent license agreement that the Company entered into with Leiden University in the Netherlands on November 2, 2009, which is affiliated with the National Institutes of Health (NIH), the Company was granted an exclusive license for the use of the patents of several compounds, including CF602 in certain territories.   The Company is committed to pay royalties as follows:   a. A one-time concession commission of €25 thousand;   b. Annual royalties of €10 thousand until the clinical trials commence;   c. 2%-3% of net sales (as defined in the agreement) received by the Company;   d. Royalties in a total amount of up to €850 thousand based on certain progress milestones in the license stages of the products, which are the subject of the patent under the agreement, as follows: (i) €50 thousand upon initiation of Phase I studies; (ii) €100 thousand upon initiation of Phase II studies; (iii) €200 thousand upon initiation of Phase III studies; and (iv) €500 thousand upon marketing approval by any regulatory authority.   e. If the agreement is sublicensed to another company, the Company will provide Leiden University royalties at a rate of 10%. A merger, consolidation or any other change in ownership will not be viewed as an assignment of the agreement as discussed in this paragraph.

v3.24.2.u1

Shareholders' Equity	6 Months Ended
	Jun. 30, 2024
Shareholders Equity [Abstract]
SHAREHOLDERS’ EQUITY	NOTE 5:- SHAREHOLDERS’ EQUITY   As of June 30, 2024 and December 31, 2023, no material accrual has been recorded with respect to Leiden University.   a. All ordinary shares have equal rights for all intent and purposes and each ordinary share confers its holder:   1. The right to be invited and participate in all the Company’s general meetings, both annual and regular, and the right to one vote per ordinary share owned in all votes and in all Company’s general meeting participated.   2. The right to receive dividends if and when declared and the right to receive bonus shares if and when distributed.   3. The right to participate in the distribution of the Company’s assets upon liquidation.   b. During the six months period ended June 30, 2024, the Company issued 296,891,100 ordinary shares previously held in abeyance. As of June 30, 2024, 157,200,000 ordinary shares held in abeyance.   c. On April 1, 2024 the Company issued 15,000,000 ordinary shares to certain service provider in exchange for PR services. The shares issued were valued at the amount of $112 which were recorded to general and administrative expenses during the six months ended June 30, 2024.   d. Share options plan:   On November 28, 2013, the board of directors approved the adoption of the 2013 Share Option Plan (the “2013 Plan”). Under the Company’s 2013 Plan, in May 2023, the Company’s Board of Directors approved to increase number of ordinary shares reserved for issuance to 85,000,000.   On August 30, 2023, the Company’s board of directors approved the adoption on a new 2023 Share Option Plan (the “2023 Plan”) and approved the reserve of 100,000,000 of the Company’s ordinary shares to issuance under the 2023 Plan.   As of June 30, 2024, 91,000,000 shares available for future grant under the Company’s 2023 Plans.   On May 7, 2024, the Company’s board of directors approved a grant of 9,000,000 options exercisable into 9,000,000 of the Company’s ordinary shares to the Company’s employees for an exercise price of NIS 0.0275 per share and 41,000,000 unlisted options exercisable into 41,000,000 of the Company’s ordinary shares to the Company’s directors and officers (subject to shareholders’ approval, which was obtained on July 3, 2024, subsequent to the balance sheet date) for the same exercise price per share. The options shall vest on a quarterly basis for a period of 4 years from the date of grant.   The fair value of the Company’s share options granted was estimated using the binomial option pricing model using the following range assumptions:   Description   May 7, 2024           Risk-free interest rate     4.64 % Expected volatility     83.40 % Dividend yield     0 % Contractual life (in years)     10   Early Exercise Multiple (Suboptimal Factor)     2.5     The following table lists the number of share options and their weighted average exercise prices in option plans of employees, directors and consultants for the six months period ended June 30, 2024 and related information:        Number of options     Weighted average exercise price     Weighted average remaining contractual terms (in years)     Aggregate intrinsic value                             Outstanding at December 31, 2023     82,477,000       0.04       8.40       -   Grants     9,000,000       0.00       9.85       -   Forfeited/expired     (5,412,500 )     -       -       -                                     Outstanding at June 30, 2024     86,064,500       0.04       5.6       0.04                                     Vested and expected to vest at June 30, 2024     86,064,500       0.04       5.6       0.04                                     Exercisable at June 30, 2024     33,998,875       0.08       5.4       -     Share based expenses recognized in the financial statements:       Six months ended June 30       2024     2023                 Research and development   $ 34     $ 50   General and administrative (*)     159       45                         $ 193     $ 95     (*) Including expenses for shares issued for services at the amount of $112, refer to Note 4c above.   a. Warrants to purchase ordinary shares:   The following table summarizes information regarding outstanding warrants to purchase the Company’s ordinary shares as of June 30, 2024:   Issuance date   Number of outstanding Warrants     Exercise price per warrant                 January 2019     223,810     $ 0.65   May 2019     47,250,000     $ 0.13   January 2020     23,838,038     $ 0.12   February 2020     11,250,000     $ 0.05   June 2020     61,390,260     $ 0.08   July 2020     29,419,890     $ 0.08   August 2021     10,500,000     $ 0.07   December 2021     10,500,000     $ 0.07   January 2023     409,091,100     $ 0.01   January 2023     28,636,500     $ 0.02   November 2023     1,219,418,700     $ 0.00                           1,851,518,298

v3.24.2.u1

Subsequent Events	6 Months Ended
	Jun. 30, 2024
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	NOTE 6:- SUBSEQUENT EVENTS   a. On July 3, 2024, the Company’s shareholders meeting approved the increase of the Company’s authorized share capital by an additional 5,000,000,000 ordinary shares such that following the increase, the authorized share capital shall be 10,000,000,000 ordinary shares.   b. On August 8, 2024, the Company entered into an inducement offer letter with a certain existing warrants holder, according to which, the holder exercised warrants exercisable for an aggregate of 857,142,900 ordinary shares (represented by 2,857,143 ADSs) for an exercise price of $0.00583 per share (or $1.75 per ADS), totaling $5 million in gross consideration. As part of the inducement letter, the Company issued to the holder new warrants to purchase 1,714,285,800 of the Company’s ordinary shares (represented by 5,714,286 ADSs) for an exercise price of $0.0075 per share (or $2.25 per ADS). The Company also issued to its placement agent new warrants exercisable into 60,000,000 ordinary shares (represented by 200,000 ADSs) at an exercise price of $0.00729167 per share or ($2.1875 per ADS).

v3.24.2.u1

Accounting Policies, by Policy (Policies)	6 Months Ended
	Jun. 30, 2024
Accounting Policies [Abstract]
Basis of Presentation:	c. Basis of Presentation: These unaudited Condensed consolidated financial statements have been prepared as of June 30, 2024 and for the six months period then ended. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been omitted. These unaudited Condensed consolidated financial statements should be read in conjunction with the audited financial statements and the accompanying notes of the Company for the year ended December 31, 2023 that are included in the Company’s Annual Report on Form 20-F, filed with the Securities and Exchange Commission on March 28, 2024 (the “Annual Report on Form 20-F”). The results of operations presented are not necessarily indicative of the results to be expected for the year ending December 31, 2024. The significant accounting policies that have been applied in the preparation of the unaudited consolidated Condensed financial statements are identical to those that were applied in preparation of the Company’s most recent annual financial statements for the year ended December 31, 2023 included in the Annual Report on Form 20-F.
Revenue Recognition – Contract Balances	d. Revenue Recognition – Contract Balances Contract liabilities include amounts received from customers for which revenue has not yet been recognized. Contract liabilities amounted to $2,071 and $2,335 as of June 30, 2024 and December 31, 2023, respectively and are presented under deferred revenues. During the six-month period ended June 30, 2024, the Company recognized revenues in the amount of $316 which have been included in the contract liabilities at December 31, 2023.

v3.24.2.u1

Fair Value Measurements (Tables)	6 Months Ended
	Jun. 30, 2024
Fair Value Measurements [Abstract]
Schedule of Financial Assets and Liabilities Measured at Fair value Recurring Basis	The Company’s financial assets and liabilities measured at fair value on a recurring basis, consisted of the following types of instruments as of the following dates: instruments as of the following dates:     June 30, 2024       Fair value measurements                             Description     Fair value       Level 1       Level 2       Level 3                                     Short-term investment   $ 9     $ 9     $ -     $ -         December 31, 2023       Fair value measurements   Description     Fair value       Level 1       Level 2       Level 3                                     Short-term investment   $ 19     $ 19     $ -     $ -

v3.24.2.u1

Earning Per Share (Tables)	6 Months Ended
	Jun. 30, 2024
Earning Per Share [Abstract]
Schedule of Computation of Basic and Diluted Net Loss Per Share	The following table sets forth the computation of basic and diluted net loss per share for the periods presented:     Six month ended June 30,       2024     2023                 Numerator:             Net loss applicable to shareholders of Ordinary Shares   $ (3,957 )   $ (4,220 )                   Denominator:                 Weighted average shares used in computing basic and diluted net loss per share *)     1,821,304,184       1,202,110,110   Net loss per share of Ordinary Share, basic and diluted   $ (0.00 )   $ (0.00 ) *) Including ordinary shares held in abeyance.
Schedule of Computation of Diluted Net Loss Per Share Attributable to Ordinary Shareholders	The potential shares of ordinary shares that were excluded from the computation of diluted net loss per share attributable to ordinary shareholders for the periods presented because including them would have been anti-dilutive are as follows:     Six month ended June 30,       2024     2023                 Options     86,064,500       42,477,000                     Warrants     1,851,518,298       1,222,016,340                     Total     1,937,582,798       1,264,493,340

v3.24.2.u1

Shareholders' Equity (Tables)	6 Months Ended
	Jun. 30, 2024
Shareholders Equity [Abstract]
Schedule of Fair value of Company’s Share Options Granted	The fair value of the Company’s share options granted was estimated using the binomial option pricing model using the following range assumptions: Description   May 7, 2024           Risk-free interest rate     4.64 % Expected volatility     83.40 % Dividend yield     0 % Contractual life (in years)     10   Early Exercise Multiple (Suboptimal Factor)     2.5
Schedule of Weighted Average Exercise Prices Share Options	The following table lists the number of share options and their weighted average exercise prices in option plans of employees, directors and consultants for the six months period ended June 30, 2024 and related information:     Number of options     Weighted average exercise price     Weighted average remaining contractual terms (in years)     Aggregate intrinsic value                             Outstanding at December 31, 2023     82,477,000       0.04       8.40       -   Grants     9,000,000       0.00       9.85       -   Forfeited/expired     (5,412,500 )     -       -       -                                     Outstanding at June 30, 2024     86,064,500       0.04       5.6       0.04                                     Vested and expected to vest at June 30, 2024     86,064,500       0.04       5.6       0.04                                     Exercisable at June 30, 2024     33,998,875       0.08       5.4       -
Schedule of Expenses Recognized Financial Statements	Share based expenses recognized in the financial statements:     Six months ended June 30       2024     2023                 Research and development   $ 34     $ 50   General and administrative (*)     159       45                         $ 193     $ 95   (*) Including expenses for shares issued for services at the amount of $112, refer to Note 4c above.
Schedule of Information Regarding Outstanding Warrants to Purchase Shares	The following table summarizes information regarding outstanding warrants to purchase the Company’s ordinary shares as of June 30, 2024: Issuance date   Number of outstanding Warrants     Exercise price per warrant                 January 2019     223,810     $ 0.65   May 2019     47,250,000     $ 0.13   January 2020     23,838,038     $ 0.12   February 2020     11,250,000     $ 0.05   June 2020     61,390,260     $ 0.08   July 2020     29,419,890     $ 0.08   August 2021     10,500,000     $ 0.07   December 2021     10,500,000     $ 0.07   January 2023     409,091,100     $ 0.01   January 2023     28,636,500     $ 0.02   November 2023     1,219,418,700     $ 0.00                           1,851,518,298

v3.24.2.u1

General (Details) - USD ($) $ in Thousands		6 Months Ended
	Aug. 08, 2024	Jun. 30, 2024	Jun. 30, 2023	Dec. 31, 2023
General [Abstract]
Number of ordinary shares in each ADS (in Shares)		300
Net losses		$ (3,957)	$ (4,220)
Net operating cash outflow		(4,036)	(5,045)
Cash and cash equivalents		4,719
Warrants exercised (in Shares)	857,142,900
Net of issuance costs	$ 4,474
Contract liabilities		2,071		$ 2,335
Revenue		$ 316	$ 392

v3.24.2.u1

Fair Value Measurements (Details) - Schedule of Financial Assets and Liabilities Measured at Fair value Recurring Basis - USD ($) $ in Thousands	Jun. 30, 2024	Dec. 31, 2023
Schedule of Financial Assets and Liabilities Measured at Fair value Recurring Basis [Line Items]
Short-term investment	$ 9	$ 19
Level 1 [Member]
Schedule of Financial Assets and Liabilities Measured at Fair value Recurring Basis [Line Items]
Short-term investment	9	19
Level 2 [Member]
Schedule of Financial Assets and Liabilities Measured at Fair value Recurring Basis [Line Items]
Short-term investment
Level 3 [Member]
Schedule of Financial Assets and Liabilities Measured at Fair value Recurring Basis [Line Items]
Short-term investment

v3.24.2.u1

Earning Per Share (Details) - Schedule of Computation of Basic and Diluted Net Loss Per Share - USD ($) $ / shares in Units, $ in Thousands		6 Months Ended
		Jun. 30, 2024	Jun. 30, 2023
Numerator:
Net loss applicable to shareholders of Ordinary Shares		$ (3,957)	$ (4,220)
Denominator:
Weighted average shares used in computing basic net loss per share	[1]	1,821,304,184	1,202,110,110
Net loss per share of Ordinary Share, basic		$ 0	$ 0
[1] Including ordinary shares held in abeyance.

v3.24.2.u1

Earning Per Share (Details) - Schedule of Computation of Basic and Diluted Net Loss Per Share (Parentheticals) - $ / shares		6 Months Ended
		Jun. 30, 2024	Jun. 30, 2023
Schedule of Computation of Basic and Diluted Net Loss Per Share [Abstract]
Weighted average shares used in computing diluted net loss per share	[1]	1,821,304,184	1,202,110,110
Net loss per share of Ordinary Share, diluted		$ 0.00	$ 0.00
[1] Including ordinary shares held in abeyance.

v3.24.2.u1

Earning Per Share (Details) - Schedule of Computation of Diluted Net Loss Per Share Attributable to Ordinary Shareholders - shares	6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023
Schedule of Computation of Diluted Net Loss Per Share Attributable to Ordinary Shareholders [Line Items]
Potential shares of ordinary shares	1,937,582,798	1,264,493,340
Options [Member]
Schedule of Computation of Diluted Net Loss Per Share Attributable to Ordinary Shareholders [Line Items]
Potential shares of ordinary shares	86,064,500	42,477,000
Warrants [Member]
Schedule of Computation of Diluted Net Loss Per Share Attributable to Ordinary Shareholders [Line Items]
Potential shares of ordinary shares	1,851,518,298	1,222,016,340

v3.24.2.u1

Contingent Liabilities and Commitments (Details) € in Thousands	6 Months Ended
	Jun. 30, 2024 EUR (€)
Contingent Liabilities and Commitments [Line Items]
Commission income expense	€ 25
Annual royalties	10
Royalties amount	€ 850
Royalty payments, percentage	10.00%
Phase I studies [Member]
Contingent Liabilities and Commitments [Line Items]
Royalties amount	€ 50
Phase II studies [Member]
Contingent Liabilities and Commitments [Line Items]
Royalties amount	100
Phase III studies [Member]
Contingent Liabilities and Commitments [Line Items]
Royalties amount	200
Regulatory Authority [Member]
Contingent Liabilities and Commitments [Line Items]
Royalties amount	€ 500
Minimum [Member]
Contingent Liabilities and Commitments [Line Items]
Percentage of net sales	2.00%
Maximum [Member]
Contingent Liabilities and Commitments [Line Items]
Percentage of net sales	(3.00%)

v3.24.2.u1

Shareholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands					6 Months Ended
	May 07, 2024	Apr. 01, 2024	Aug. 30, 2023	Nov. 28, 2013	Jun. 30, 2024
Shareholders' Equity [Line Items]
Shares held in abeyance					296,891,100
Expenses for shares issued for services (in Dollars)					$ 112
Shares available for future grant					91,000,000
Share grant					9,000,000
Ordinary per share issued (in Dollars per share)	$ 0.0275
Options exercisable					33,998,875
Date of grant					5 years 7 months 6 days
Leiden University [Member]
Shareholders' Equity [Line Items]
Shares held in abeyance					157,200,000
Board of Directors [Member]
Shareholders' Equity [Line Items]
Increase number of ordinary shares				85,000,000
Share grant	9,000,000
Option exerisable	9,000,000
Ordinary Shares [Member]
Shareholders' Equity [Line Items]
Share-based payments shares issued		15,000,000
Expenses for shares issued for services (in Dollars)					$ 112
Increase number of ordinary shares			100,000,000
Option exerisable	41,000,000
Options exercisable	41,000,000
Date of grant	4 years

v3.24.2.u1

Shareholders' Equity (Details) - Schedule of Fair value of Company’s Share Options Granted	May 07, 2024
Schedule of Fair value of Company’s Share Options Granted [Abstract]
Risk-free interest rate	4.64%
Expected volatility	83.40%
Dividend yield	0.00%
Contractual life (in years)	10 years
Early Exercise Multiple (Suboptimal Factor)	2.5

v3.24.2.u1

Shareholders' Equity (Details) - Schedule of Weighted Average Exercise Prices Share Options - $ / shares		6 Months Ended
	Dec. 31, 2023	Jun. 30, 2024
Schedule of Weighted Average Exercise Prices Share Options [Abstract]
Number of options, Grants (in Shares)		9,000,000
Weighted average exercise price, Grants		$ 0
Weighted average remaining contractual terms, Grants		9 years 10 months 6 days
Aggregate intrinsic value , Grants
Number of options, Forfeited/expired (in Shares)		(5,412,500)
Weighted average exercise price, Forfeited/expired
Aggregate intrinsic value, Forfeited/expired
Number of options, Ending (in Shares)	82,477,000	86,064,500
Weighted average exercise price, Ending	$ 0.04	$ 0.04
Weighted average remaining contractual terms, Ending	8 years 4 months 24 days	5 years 7 months 6 days
Aggregate intrinsic value, Ending		$ 0.04
Number of options, Vested and expected to vest (in Shares)		86,064,500
Weighted average exercise price, Vested and expected to vest		$ 0.04
Weighted average remaining contractual terms, Vested and expected to vest		5 years 7 months 6 days
Aggregate intrinsic value, Vested and expected to vest		$ 0.04
Number of options, Exercisable (in Shares)		33,998,875
Weighted average exercise price, Exercisable		$ 0.08
Weighted average remaining contractual terms, Exercisable		5 years 4 months 24 days
Aggregate intrinsic value, Exercisable

v3.24.2.u1

Shareholders' Equity (Details) - Schedule of Expenses Recognized Financial Statements - USD ($) $ in Thousands		6 Months Ended
		Jun. 30, 2024	Jun. 30, 2023
Schedule of Expenses Recognized Financial Statements [Line Items]
Share based expenses recognized		$ 193	$ 95
Research and development [Member]
Schedule of Expenses Recognized Financial Statements [Line Items]
Share based expenses recognized		34	50
General and administrative [Member]
Schedule of Expenses Recognized Financial Statements [Line Items]
Share based expenses recognized	[1]	$ 159	$ 45
[1] Including expenses for shares issued for services at the amount of $112, refer to Note 4c above.

v3.24.2.u1

Shareholders' Equity (Details) - Schedule of Information Regarding Outstanding Warrants to Purchase Shares - Warrants [Member]	6 Months Ended
	Jun. 30, 2024 $ / shares shares
Schedule of Information Regarding Outstanding Warrants to Purchase Shares [Line Items]
Number of outstanding warrants	1,851,518,298
January 2019 [Member]
Schedule of Information Regarding Outstanding Warrants to Purchase Shares [Line Items]
Issuance date	January 2019
Number of outstanding warrants	223,810
Exercise price per warrant (in Dollars per share) | $ / shares	$ 0.65
May 2019 [Member]
Schedule of Information Regarding Outstanding Warrants to Purchase Shares [Line Items]
Issuance date	May 2019
Number of outstanding warrants	47,250,000
Exercise price per warrant (in Dollars per share) | $ / shares	$ 0.13
January 2020 [Member]
Schedule of Information Regarding Outstanding Warrants to Purchase Shares [Line Items]
Issuance date	January 2020
Number of outstanding warrants	23,838,038
Exercise price per warrant (in Dollars per share) | $ / shares	$ 0.12
February 2020 [Member]
Schedule of Information Regarding Outstanding Warrants to Purchase Shares [Line Items]
Issuance date	February 2020
Number of outstanding warrants	11,250,000
Exercise price per warrant (in Dollars per share) | $ / shares	$ 0.05
June 2020 [Member]
Schedule of Information Regarding Outstanding Warrants to Purchase Shares [Line Items]
Issuance date	June 2020
Number of outstanding warrants	61,390,260
Exercise price per warrant (in Dollars per share) | $ / shares	$ 0.08
July 2020 [Member]
Schedule of Information Regarding Outstanding Warrants to Purchase Shares [Line Items]
Issuance date	July 2020
Number of outstanding warrants	29,419,890
Exercise price per warrant (in Dollars per share) | $ / shares	$ 0.08
August 2021 [Member]
Schedule of Information Regarding Outstanding Warrants to Purchase Shares [Line Items]
Issuance date	August 2021
Number of outstanding warrants	10,500,000
Exercise price per warrant (in Dollars per share) | $ / shares	$ 0.07
December 2021 [Member]
Schedule of Information Regarding Outstanding Warrants to Purchase Shares [Line Items]
Issuance date	December 2021
Number of outstanding warrants	10,500,000
Exercise price per warrant (in Dollars per share) | $ / shares	$ 0.07
January 2023 [Member]
Schedule of Information Regarding Outstanding Warrants to Purchase Shares [Line Items]
Issuance date	January 2023
Number of outstanding warrants	409,091,100
Exercise price per warrant (in Dollars per share) | $ / shares	$ 0.01
January 2023 One [Member]
Schedule of Information Regarding Outstanding Warrants to Purchase Shares [Line Items]
Issuance date	January 2023
Number of outstanding warrants	28,636,500
Exercise price per warrant (in Dollars per share) | $ / shares	$ 0.02
November 2023 [Member]
Schedule of Information Regarding Outstanding Warrants to Purchase Shares [Line Items]
Issuance date	November 2023
Number of outstanding warrants	1,219,418,700
Exercise price per warrant (in Dollars per share) | $ / shares	$ 0

v3.24.2.u1

Subsequent Events (Details) - Subsequent Event [Member] - $ / shares	Aug. 08, 2024	Jul. 03, 2024
Subsequent Events [Line Items]
Increase in authorized ordinary shares		5,000,000,000
Exercised warrants	857,142,900
Warrant exercise price per share (in Dollars per share)	$ 0.00583
New Warrants to Purchase [Member]
Subsequent Events [Line Items]
Exercised warrants	60,000,000
Warrant exercise price per share (in Dollars per share)	$ 0.00729167
Warrant purchase	1,714,285,800
Ordinary Shares [Member]
Subsequent Events [Line Items]
Increase in authorized ordinary shares		10,000,000,000
Warrant exercise price per share (in Dollars per share)	$ 0.0075
ADR [Member]
Subsequent Events [Line Items]
Exercised warrants	2,857,143
Warrant exercise price per share (in Dollars per share)	$ 2.1875
Warrant purchase	5,714,286
ADR [Member] | New Warrants to Purchase [Member]
Subsequent Events [Line Items]
Exercised warrants	200,000
Warrant exercise price per share (in Dollars per share)	$ 1.75
Warrant [Member] | ADR [Member]
Subsequent Events [Line Items]
Warrant exercise price per share (in Dollars per share)	$ 2.25

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