midastouch017
5月前
Can-Fite Announces Reverse Split of its Ordinary Shares and ADS Ratio Change
https://finance.yahoo.com/news/fite-announces-reverse-split-ordinary-214600798.html
RAMAT GAN, Israel, Dec. 23, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small-molecule drugs targeting oncological and inflammatory diseases, announced today that following the approval of its shareholders on November 10, 2025, its Board of Directors has approved a 1-for-3,000 reverse split of the Company’s ordinary shares. The reverse split will be recorded with the Tel-Aviv Stock Exchange on January 2, 2026 and on January 4, 2026, the Tel-Aviv Stock Exchange will be closed. The first trading date for the newly consolidated ordinary shares on the Tel-Aviv Stock Exchange will be January 5, 2026.
The reverse split will result in each outstanding three thousand pre-split ordinary shares automatically combining into one new ordinary share, no par value, without any further action on the part of the shareholders. Concurrently with the reverse split, the Company will effect a corresponding change in the ratio of ordinary shares underlying each of the Company’s American Depositary Shares (ADSs), such that its ratio of ADSs to ordinary shares will change from one (1) ADS representing three hundred (300) ordinary shares to a new ratio of one (1) ADS representing two (2) ordinary shares and no adjustment will be made to the outstanding number of the ADSs of the Company. The ratio change will be effective on the NYSE American on January 5, 2026.
For ADS holders, the ratio change will have the same effect as a one-for-twenty ADS split. On the effective date, each ADS holder will be required to exchange every twenty (20) ADSs then held for one (1) new ADS. The Bank of New York Mellon, the depositary bank, will arrange for the exchange of the current ADSs for the new ones. The Company’s ADSs will continue to trade on the NYSE American under the symbol “CANF” with a new CUSIP Number 13471N409.
The total number of outstanding ordinary shares will be reduced on the effective date at a ratio of three thousand-for-one. The Company’s authorized number of ordinary shares will also be proportionately decreased from 42,000,000,000 to 14,000,000 ordinary shares, no par value, each as a result of the reverse split. No fractional ordinary shares will be issued as a result of the reverse split as any fractional ordinary shares resulting from the reverse split will be rounded up to the nearest whole share on a per shareholder basis.
The reverse split and ADS ratio change will not impact any shareholder’s percentage ownership of the Company or voting power, except for minimal effects resulting from the treatment of fractional shares.
No fractional new ADSs will be issued in connection with the change in the ADS ratio. Instead, fractional entitlements to new ADSs will be aggregated and sold by the depositary bank and the net cash proceeds from the sale of the fractional ADS entitlements (after deduction of fees, taxes and expenses) will be distributed to the applicable ADS holders by the depositary bank.
As a result of the change in the ADS ratio, the ADS price is expected to increase proportionally, although the Company can give no assurance that the ADS price after the change in the ADS ratio will be equal to or greater than twenty times the ADS price before the change.
midastouch017
6月前
Can-Fite Provides Update on Clinical and Financial Status
https://finance.yahoo.com/news/fite-provides-clinical-financial-status-141900611.html
RAMAT GAN, Israel, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small-molecule drugs targeting oncological and inflammatory diseases, today announced an update on its clinical development activities and financial status.
Namodenoson drug candidate: Can-Fite is currently enrolling patients in a pivotal Phase III clinical study evaluating Namodenoson for the treatment of advanced hepatocellular carcinoma (HCC) in patients with Child-Pugh B7 liver function. This patient population represents a significant unmet medical need, as no approved therapies are currently available. An interim analysis from the Phase III study is expected to be in approximately Q4 2026. Subject to positive interim results, the Company may be eligible to seek conditional regulatory approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
In parallel, Can-Fite is enrolling patients in a Phase IIb clinical study of Namodenoson for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). This study follows positive results from a completed Phase IIa trial, which demonstrated anti-inflammatory, anti-steatotic, and anti-fibrotic effects, with data published in peer-reviewed literature.
In addition, Namodenoson is being evaluated in a Phase IIa clinical study in patients with pancreatic cancer who have failed first-line treatment. Patient enrollment in this study is nearing completion, and the Company expects to report data during the second quarter of 2026.
Piclidenoson drug candidate: Can-Fite is currently enrolling patients in a pivotal Phase III clinical study for the treatment of psoriasis. In this study, patients receive Piclidenoson orally, administered twice daily. The primary efficacy endpoints of the trial are PASI 75 (Psoriasis Area and Severity Index) and Physician’s Global Assessment (PGA), consistent with regulatory guidance for late-stage psoriasis studies. Based on the Company’s current assumptions, interim analysis data is expected to be released in the second quarter of 2026. The Company also completed the development of a Phase II study protocol for the rare genetic disease Lowe Syndrome and plans to submit it to regulatory authorities in Italy and EMA during Q1 2026.
Cash and cash equivalents: As of June 30, 2025, Can-Fite had cash and cash equivalents and short term deposits of $6.45 million. On July 28, 2025, Can-Fite completed a public offering for aggregate gross proceeds of $5 million. In November 2025 Can-Fite Raised $2.2M through its ATM facility.
“Our advancing clinical programs reflect Can-Fite’s focused strategy of addressing significant unmet medical needs with orally administered, well-characterized drug candidates,” said Motti Farbstein, Chief Executive Officer of Can-Fite BioPharma. “With pivotal Phase III studies ongoing in liver cancer and psoriasis, alongside progressing mid-stage programs in MASH and pancreatic cancer, we believe we are well positioned to generate meaningful clinical data over the coming quarters while maintaining disciplined execution.”
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 reported topline results in a Phase III trial for psoriasis and commenced a pivotal Phase III trial. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in 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: https://www.canfite.com/.
Forward-Looking Statements
This press release contains forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts and expectations with respect to the timing of release of data and regulatory submissions. 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 April 7, 2025 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
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midastouch017
9月前
Can-Fite Reports H1 2025 Financial Results and Clinical Update
Ramat Gan, Israel, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced financial results and clinical updates for H1, 2025.
Clinical & Development Milestones Achieved
Namodenoson Drug Candidate –
Pancreatic Cancer Phase 2a Study with Can-Fite’s Namodenoson Achieved Over 50% Enrollment Milestone
The Phase 2a study (NCT06387342) is a multicenter, open-label trial enrolling patients with advanced pancreatic adenocarcinoma whose disease has progressed following at least one line of prior therapy. The study is evaluating the safety (primary endpoint), clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. Participants receive oral Namodenoson at a dose of 25 mg, administered twice daily in continuous 28-day cycles. Patients are regularly monitored for safety, and to date, Namodenoson has demonstrated a favorable safety profile. The study is led by Prof. Salomon Stemmer, a renowned oncologist and key opinion leader at the Davidoff Center, Rabin Medical Center, Israel.
Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.
Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. The designation as an orphan drug will provide, among others, potential for market exclusivity for seven years after approval and several and regulatory advantages (https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions).
Following FDA Compassionate Use Approval for Pancreatic Carcinoma with Can-Fite’s Namodenoson, Leading U.S. Medical Centers Seek Authorization for their Patients
Namodenoson has recently received FDA approval for its first single-patient compassionate use treatment, marking a significant milestone in its clinical journey. This approval has sparked growing interest from oncologists at leading U.S. medical centers, who are now seeking to treat their pancreatic cancer patients with Namodenoson under compassionate use protocols.
Piclidenoson Drug Candidate –
Breakthrough Study from UCLA Demonstrate Can-Fite’s Piclidenoson as a Treatment for Vascular Dementia
The study headed by Dr. S. Thomas Carmichael, M.D., Ph.D., Professor and Chair Frances Stark Chair, Department of Neurology, Geffen School of Medicine at UCLA, utilized a vascular dementia mouse model with focal ischemia replicating many elements of the complex pathophysiology of human vascular dementia. Piclidenoson was found to restore tissue integrity and behavioral function in this vascular dementia model.
Vascular dementia is the second most common cause of dementia after Alzheimer’s disease, and caused by impaired blood flow to the brain, often due to stroke or chronic small vessel disease. There are no U.S. FDA approved therapies for this condition. Drugs that are used off-label, including donepezil or memantine, are used symptomatically or to address co-morbidities. Additionally, antihypertensives, antiplatelets, and statins are used to prevent further vascular damage, but none of these medications are disease-modifying. Nevertheless, due to an aging population and increasing diagnosis, the global market for Vascular Dementia is estimated at $6 billion as of 2025, with an expected CAGR of 5% through 2035.
Piclidenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile in hundreds of patients with Psoriasis and demonstrated anti-inflammatory activity in Phase 2 and Phase 3 clinical studies.
Financial Results
Revenues for the six months ended June 30, 2025 were $0.20 million, a decrease of $0.11 million, or 36.07%, compared to $0.31 million for the six months ended June 30, 2024. The decrease in revenues was mainly due to the recognition a lower portion of advance payments received under the Ewopharma distribution agreement entered in 2021 and a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.
Research and development expenses for the six months ended June 30, 2025 were $3.03 million, an increase of $0.15 million, or 5.16%, compared to $2.88 million for the six months ended June 30, 2024. Research and development expenses for the first half of 2025 comprised primarily of expenses associated with the ongoing of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for MASH. The increase is primarily due to acceleration in expenses associated with both Namodenoson and Piclidenoson.
General and administrative expenses for the six months ended June 30, 2025 were $2.07 million an increase of $0.54 million, or 35.47%, compared to $1.52 million for the six months ended June 30, 2024. The increase is primarily due to the increase in investors relationship expenses following one time project occurred during the first half of 2025. We expect that general and administrative expenses will remain at the same level through 2025.
Financial income, net for the six months ended June 30, 2025 was $0.02 million compared to $0.13 million for the six months ended June 30, 2024. 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, 2025 was $4.87 million compared with a net loss of $3.95 million for the six months ended June 30, 2024. The increase in net loss for the six months ended June 30, 2025 was primarily attributable to an increase in research and development expenses and an increase in general and administrative expenses.
As of June 30, 2025, Can-Fite had cash and cash equivalents and short term deposits of $6.45 million as compared to $7.88 million at December 31, 2024. The decrease in cash during the six months ended June 30, 2025 is mainly due to ongoing operations of the Company. On July 28, 2025, the Company completed a public offering for aggregate gross proceeds of $5 million.
The Company’s consolidated financial results for the six months ended June 30, 2025 are presented in accordance with US GAAP Reporting Standards.
midastouch017
1年前
Can-Fite Has Raised $175 Million in Total to Date for the Development of Namodenoson and Piclidenoson, Advancing into Pivotal Phase 3 Trials in Liver Cancer and Psoriasis
https://finance.yahoo.com/news/fite-raised-175-million-total-120000780.html
Ramat Gan, Israel, May 05, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small-molecule drugs for oncological and inflammatory diseases, today announced that, it has raised $175 million in funding to date. These funds have enabled the advancement of its lead drug candidates, Namodenoson and Piclidenoson, into pivotal Phase III studies for liver cancer and psoriasis, respectively.
Can-Fite is a recognized leader in the development of small-molecule therapeutics targeting the A3 adenosine receptor (A3AR), which is highly expressed in both inflammatory and cancer cells. Namodenoson, an orally bioavailable A3AR agonist, is currently enrolling patients in a pivotal Phase III study for advanced liver cancer. It has demonstrated selective targeting of liver and pancreatic tumor cells while sparing healthy tissue. Piclidenoson, also an orally administered A3AR agonist, is in a pivotal Phase III trial for patients with moderate-to-severe psoriasis.
Both candidates have shown favorable safety profiles, anti-cancer and anti-inflammatory properties, and promising efficacy in previous Phase II trials. Cumulative funding has also supported drug manufacturing, regulatory activities with the FDA and EMA, and the development of a broad patent portfolio providing extensive intellectual property protection.
In addition to its lead programs, Can-Fite is conducting a Phase IIa study of Namodenoson in pancreatic cancer, following successful preclinical studies demonstrating its ability to inhibit tumor growth by modulating the Wnt/ß-catenin, NF-?B, and RAS signaling pathways. A Phase IIb trial in metabolic dysfunction-associated steatohepatitis (MASH) is also underway under an open IND with the FDA, leveraging Namodenoson’s hepatoprotective effects.
To date, Can-Fite has signed seven commercialization agreements with strategic partners for the future marketing of its drug candidates upon regulatory approval. Can-Fite continues to engage with potential partners and seeks to sign additional commercialization agreements in the future.
Motti Farbstein, CEO of Can-Fite, commented: "This funding milestone reflects the strong confidence our investors and partners have in Can-Fite’s scientific platform and clinical strategy. Progressing into pivotal Phase III trials marks a significant step toward bringing innovative, oral therapies to patients with serious unmet needs in liver cancer and psoriasis."
midastouch017
1年前
Can-Fite to Generate $685M in Projected Future Revenues from its Partnerships
https://finance.yahoo.com/news/fite-generate-685m-projected-future-123000278.html
Ramat Gan, Israel, April 14, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small-molecule drugs for oncological and inflammatory diseases, today announced the completion of a comprehensive analysis of its current partnerships and the market potential for its lead drug candidates, Piclidenoson and Namodenoson upon regulatory approvals.
Based on in-depth internal modeling and insights from external advisors, the Company forecasts potential substantial revenue generation over the next decade from its two drug candidates, currently in development for four key indications: psoriasis, advanced liver cancer, pancreatic cancer, and MASH, which assumes, among other things, regulatory approval and launches between 2027 and 2029, depending on the indication and territory. Can-Fite’s seven partnerships are structured with diverse financial components, including development and regulatory milestones, commercial sales benchmarks, manufacturing-related transfer payments, and royalties on product sales. Integrating these partnership terms into its projections, the Company anticipates potential significant cumulative income from multiple revenue streams, reinforcing its potential long-term growth prospects based on assumed achievement of milestones, regulatory approval, launches, market penetration and market size.
“While we emphasize these figures are derived from our forecasts and subject to inherent uncertainties of drug development and commercialization, we remain highly encouraged by these projections. They underscore the robust strategic foundation that we have built through our diverse collaborations, reflecting both the significant commercial opportunities and potential long-term value we aim to deliver to our shareholders”, stated Can-Fite VP Business Development Dr. Sari Fishman.
midastouch017
1年前
Can-Fite Reports 2024 Financial Results and Clinical Update
https://finance.yahoo.com/news/fite-reports-2024-financial-results-120000727.html
Cancer-Free Survival of 8 Years in Liver Cancer Patient Treated with Namodenoson in Prior Phase II Study
RAMAT GAN, Israel, April 14, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced financial results and clinical updates for the year ended December 31, 2024.
Clinical & Development Milestones Achieved
Namodenoson Drug Candidate:
Liver Cancer - A patient, who initially had an overall survival time of 8 years, currently treated with Namodenoson in a compassionate use program in the former Can-Fite Phase II study has evidenced a complete cure manifested by the disappearance of all metastases, normal liver function and good quality of life. In addition, the Company has found that Namodenoson has protective effects on top of the anti-cancer activity that was presented at the 2025 ASCO Gastrointestinal Cancers Symposium and also published in European Society of Medicine Journal entitled: “The Neuro- Cardio- and Hepato- Protective Effects of Namodenoson are Mediated by Adiponectin”. The article presents compelling preclinical and clinical data demonstrating Namodenoson’s potent anti-ischemic, anti-inflammatory, anti-fibrotic, and anti-toxicity effects across multiple body tissues, including the liver, central nervous system and cardiovascular system. The study highlights Namodenoson’s ability to increase adiponectin levels, a key cytokine known to drive multi-organ protective effects. Importantly, the manuscript underscores Namodenoson’s dual role as both an anti-cancer therapy and a protective agent for normal tissues, setting it apart from conventional chemotherapy and other oncology treatments with significant toxicity.
Pancreatic Cancer - Namodenoson has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the indication of pancreatic cancer, one of the most aggressive malignancies. The designation as an orphan drug will provide, among others, potential for market exclusivity for seven years after approval and several and regulatory advantages (https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions). In addition, the Company initiated a Phase IIa clinical trial in patients with advanced pancreatic adenocarcinoma (NCT06387342). The Phase IIa study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first-line therapy. The trial is evaluating the safety, clinical activity and pharmacokinetics (PK) of Namodenoson in this patient population. Recently, the FDA approved compassionate use treatment of a U.S.-based pancreatic cancer patient with its anti-cancer drug Namodenoson.
Anti-Obesity - Namodenoson was granted a patent for its use as an anti-obesity drug by the U.S. patent office. The patent application (No. 17/309,952) entitled, “An A3 adenosine receptor ligand for use for achieving a fat loss effect”, has been accepted by the U.S. Patent Office, was issued in February 2024 and expires in 2042.
The patent application covers methods of treating obese patients by administering Namodenoson in an oral formulation. In addition, the Company was also granted a patent application (No.2020205042) for the anti-obesity indication by the Australian Patent Office, which expires in 2040.
Piclidenoson Drug Candidate:
Psoriasis – Can-Fite initiated a pivotal phase 3 psoriasis study of its oral drug, Piclidenoson, with the FDA and the European Medicines Agency (EMA). The study will enroll patients with moderate to severe plaque psoriasis. Patient enrolment will be initiated in Europe, with the U.S. and Canada expected to follow.
Lowe Syndrome - Can-Fite recently entered into the clinical development of implementing Piclidenoson into the treatment of the rare genetic disease, Lowe Syndrome. A Phase II design has been completed and preparatory work is being undertaken to initiate the study that will be conducted by Dr. Franchesca Emma from the Division of Nephrology, Bambino Gesù Children's Hospital - IRCCS Rome Italy. The Phase II open-label study will enroll 5 patients that will be treated twice daily with 3 mg Piclidenoson for 12 months. The study’s primary end point will be the efficacy of Piclidenoson in increasing 99mTc-DMSA renal uptake.
Canine Osteoarthritis – Can-Fite partnered with Vetbiolix for the development of Piclidenoson for canine osteoarthritis and successfully concluded a clinical study in dogs with osteoarthritis who were treated orally with Piclidenoson for a period of a few months. The arthritis market for companion animals was estimated by Coherent Market Insights to be $3.8 Billion in 2023 and is expected to grow to $6.3 Billion by 2030. Can-Fite and Vetbiolix model that Piclidenoson has the potential to capture up to 6% of this opportunity, with peak worldwide sales of $445 Million by 2034. Under the agreement, Can-Fite is entitled to receive a 15% royalty on worldwide sales in this indication. This means that Can-Fite’s upfront and royalties on sales upon regulatory approval for veterinary use is projected to be $325 million in the aggregate over the next decade assuming a 2029 launch. In addition, Vetbiolix is initiating an advanced clinical study in dogs with osteoarthritis, utilizing oral daily treatment with Piclidenoson. Expected registration of Piclidenoson for this indication is anticipated to be in 2029.
Financial Results
Revenues for the year ended December 31, 2024 were $0.67 million, a decrease of $0.07 million, or 9.3%, compared to $0.74 million for the year ended December 31, 2023. The decrease in revenues was mainly due to the recognition a lower portion of advance payments received under distribution agreements that the Company previously entered into, offset by a recognition of advance payment received under the license agreement with Vetbiolix.
Research and development expenses for the year ended December 31, 2024 were $5.75 million, a decrease of $0.23 million, or 3.8%, compared to $5.98 million for the year ended December 31, 2023. Research and development expenses for the year ended December 31, 2024 comprised primarily of expenses associated with the completion of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson: a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for MASH. The decrease is primarily due to a decrease in expenses associated with Piclidenoson.
General and administrative expenses were $3.04 million for the year ended December 31, 2024, an increase of $0.09 million, or 3.1%, compared to $2.95 million for the year ended December 31, 2023. The increase is primarily due to higher public relations expenses. The Company expects that general and administrative expenses will remain at the same level through 2025.
Financial income, net for the year ended December 31, 2024, aggregated $0.25 million, compared to $0.56 million for the year ended December 31, 2023. The decrease in financial income, net was mainly due to a decrease in interest from deposits.
Net loss for the year ended December 31, 2024, was $7.88 million, compared with a net loss of $7.63 million for the same period in 2023. The increase in net loss for the year ended December 31, 2024, is considered immaterial.
As of December 31, 2024, Can-Fite had cash and cash equivalents and short term deposits of $7.88 million as compared to $8.90 million as of December 31, 2023. The decrease in cash during the year ended December 31, 2024 is due to the ongoing operations of the Company.
The Company's consolidated financial results for the year ended December 31, 2024 are presented in accordance with US GAAP Reporting Standards.
More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2024, a copy of which has been filed with the Securities and Exchange Commission (SEC). The Annual Report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at http://www.sec.gov/ as well as via the Company’s investor relations website at https://ir.canfite.com. The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Can-Fite Investor Relations at 26 Ben Gurion Street, Ramat Gan, 5257346, Israel or by phone at +972-3-9241114.
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
December 31,
2024
2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
4,825
$
4,278
Short term deposits
3,057
4,625
Prepaid expenses and other current assets
1,095
986
Short-term investment
5
19
Total current assets
8,982
9,908
NON-CURRENT ASSETS:
Operating lease right of use assets
111
52
Property, plant and equipment, net
27
29
Total non-current assets
138
81
Total assets
$
9,120
$
9,989
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
December 31,
2024
2023
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
618
$
427
Current maturity of operating lease liability
53
27
Deferred revenues
405
622
Other accounts payable
976
944
Total current liabilities
2,052
2,020
NON-CURRENT LIABILITIES:
Long - term operating lease liability
51
13
Deferred revenues
1,581
1,713
Total long-term liabilities
1,632
1,726
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of no-par value - Authorized: 10,000,000 and 5,000,000,000 shares at December 31, 2024 and December 31, 2023; Issued and outstanding: 2,983,181,793 and 1,359,837,393 shares as of December 31, 2024 and December 31, 2023
-
-
Additional paid-in capital
170,670
163,597
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(166,361
)
(158,481
)
Total shareholders’ equity
5,436
6,243
Total liabilities and shareholders’ equity
$
9,120
$
9,989
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share data)
Year ended December 31,
2023
2022
Revenues
$
674
$
743
Research and development expenses
(5,757
)
(5,983
)
General and administrative expenses
(3,047
)
(2,955
)
Operating loss
(8,130
)
(8,195
)
Total financial income, net
250
561
Net loss
(7,880
)
(7,634
)
Basic and diluted net loss per share
(0.00
)
(0.01
)
Weighted average number of ordinary shares used in computing basic and diluted net loss per share
2,175,926,512
1,278,333,912
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 reported topline results in a Phase III trial for psoriasis and commenced a pivotal Phase III trial. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in 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: https://www.canfite.com/.
midastouch017
1年前
Can-Fite to Initiate Phase II Study in the Rare Genetic Disease Lowe Syndrome with Piclidenoson
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 that a Phase II design is completed and preparatory work is undergoing for the initiation of clinical study in the rare genetic disease Lowe Syndrome.
Dr. Franchesca Emma from the Division of Nephrology, Bambino Gesù Children's Hospital - IRCCS Rome Italy, will be the principal investigator of the study. The Phase II open study will enroll 5 patients that will be treated twice daily with 3 mg Piclidenoson for 12 months. The study’s primary end point will be the efficacy of Piclidenoson in increasing 99mTc-DMSA renal uptake.
The treatment of this rare genetic disease is based on successful pre-clinical work of Dr. Antonella De Matteis, Professor of Biology, Department of Molecular Medicine and Medical Biotechnology at the University of Naples Federico II, and Program Coordinator of the Cell Biology and Disease Mechanisms at the Telethon Institute of Genetics and Medicine (TIGEM) in Italy. Can-Fite and Fondazione Telethon have signed a collaboration agreement for the clinical development of Piclidenoson for the treatment of Lowe Syndrome, a high medical need with no drug available.
Lowe Syndrome, also known as oculo-cerebro- renal syndrome (OCRL), an X-linked genetic condition occurring almost exclusively in males, is a multisystem disorder characterized by vision problems including clouding of the lenses of the eyes (cataracts) that are present at birth, kidney problems (consisting of urinary loss of proteins and solutes) that usually develop in the first year of life, and brain abnormalities associated with intellectual disabilities, and a life span that rarely exceeds 40 years. Lowe Syndrome prevalence is estimated at approximately 1 in 500,000.
“Having tested thousands of compounds in search of a treatment for Lowe Syndrome, Piclidenoson is the only compound we’ve found to date that has shown to be effective in pre-clinical studies. Importantly, we observed that Piclidenoson treatment in preclinical models of Lowe syndrome leads to a significant decrease of the urinary loss of proteins,” Dr. De Matteis stated. “We chose to investigate Piclidenoson based on the availability of extensive scientific data showing its excellent safety, coupled with efficacy in this disease in pre-clinical studies which involves renal, cerebral, and ocular manifestations.”
Can-Fite CSO&Chairperson Dr. Pnina Fishman commented, “We are very much enthusiastic by the breakthrough research of Dr. De Matteis showing that Piclidenoson is efficacious in treating pre-clinical models of Lowe Syndrome. Her impressive results are the basis for implementing Piclidenoson in the treatment of this rare genetic disease”. stated Dr. Pnina Fishman, Can-Fite CSO & Chairperson”.
About Piclidenoson
Piclidenoson is a robust anti-inflammatory agent, currently being evaluated in a pivotal Phase III psoriasis clinical study under approval of both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety profile demonstrating evidence of efficacy in Phase II and Phase III clinical studies. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity.
About Fondazione Telethon
Fondazione Telethon ETS is one of the main Italian biomedical charities, founded in 1990 on the initiative of a group of patients suffering from muscular dystrophy. Its mission is to achieve the cure of rare genetic diseases through scientific research of excellence, selected according to the best practices shared internationally. Through a unique method in the Italian panorama, it follows the entire "research chain" dealing with fundraising, selection and funding of projects and the research activity itself carried out in the centers and laboratories of the Foundation. Telethon also develops collaborations with public health institutions and pharmaceutical industries to translate the results of research into therapies accessible to patients. Since its foundation, Telethon has invested more than 660 million euros in research, has funded 2,960 projects with 1,720 researchers involved and 630 diseases studied. To date, thanks to Fondazione Telethon, the first gene therapy with stem cells in the world has been made available, thanks to the collaboration with the pharmaceutical industry. This therapy is intended for the treatment of ADA-SCID, a severe immunodeficiency that compromises the body's defenses from birth. In 2023, Fondazione Telethon became responsible for the production and distribution of the drug to eligible patients in the European Union.
Another gene therapy resulting from Telethon research made available is the one for a serious neurodegenerative disease, metachromatic leukodystrophy. This therapeutic approach is in an advanced stage of development for another immunodeficiency, Wiskott-Aldrich syndrome. Other diseases on which the gene therapy developed by Telethon researchers has been evaluated in patients are beta thalassemia and two metabolic diseases of childhood, mucopolysaccharidosis type 6 and type 1. In addition, within the Telethon institutes a targeted therapeutic strategy is being studied or developed for other genetic diseases, such as hemophilia or various hereditary vision defects. In parallel, the study of basic mechanisms and potential therapeutic approaches for diseases still unanswered continues in all laboratories funded by Telethon.
midastouch017
1年前
Recognition of the American Society of Clinical Oncology (ASCO) of the Liver Protective Effect of Can-Fite’s anti-Cancer Drug Namodenoson
https://finance.yahoo.com/news/recognition-american-society-clinical-oncology-120000975.html
Can-Fite’s data will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium
Can-Fite enrolls patients for its pivotal Phase III advanced liver cancer study
Ramat Gan, Israel, Dec. 30, 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 Oncology and Inflammatory diseases, today announced that its work titled “The Liver Protective Effect of the anti-Cancer Drug Candidate Namodenoson is Mediated via Adiponectin” will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium to take place at San Francisco & On Line, January 23-25.
Currently, Namodenoson is being evaluated in a pivotal Phase 3 multinational registrational trial for the treatment of advanced liver cancer (Hepatocellular Carcinoma; HCC). Interestingly, Namodenoson has also completely cleared cancer in an HCC patient who was enrolled in Can-Fite’s Phase 2b HCC trial. The patient continues to be treated through a compassionate use program in Romania, where she remains cancer-free for more than 8 years following her first dose of Namodenoson.
The uniqueness of Namodenoson is that beyond its anti-cancer activity, it also induces a liver-protective effect. The latter is manifested by anti-steatosis, anti-inflammatory, anti-fibrotic, and anti-ischemic effects in the liver. Can-Fite researchers also found that the molecular mechanism of the protective effect is mediated via adiponectin protein, a positive cytokine released by adipocytes and endothelial cells in the body, known to induce liver-, cardio-, and neuro-protective effects.
Namodenoson has received significant acknowledgment in the scientific and medical communities, as evidenced by the numerous peer-reviewed publications and conferences, in which it has been published and presented.
“Our Phase 3 registrational trial is designed to treat patients who have tried, yet not benefitted from the few other FDA-approved HCC treatments on the market today. In distinction from these drugs which induce liver toxicity on top of their anti-cancer effect, Namodenoson has the advantage of having a liver-protective effect and therefore can be administered to patients with advanced disease,” stated Can-Fite CSO & Chairperson Dr. Pnina Fishman. We are hopeful that Namodenoson, with its liver-protective properties, can safely prolong life for advanced liver cancer patients.”
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
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. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of MASH a Phase III 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: https://www.canfite.com/.