midastouch017
3 days ago
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
3 days ago
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
4 weeks ago
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
4 months ago
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/.
midastouch017
6 months ago
Significant Positive Results from Osteoarthritis Clinical Study in Dogs Treated with Piclidenoson
https://finance.yahoo.com/news/significant-positive-results-osteoarthritis-clinical-130600948.html
Data Reported by Can-Fite Veterinary Partner Vetbiolix who already exercised its option for a full license deal worth $325M
Ramat Gan, Israel, Oct. 18, 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 that its veterinary partner Vetbiolix reported positive final results from the osteoarthritis multicenter clinical study in dogs treated with Piclidenoson. Vetbiolix, Can-Fite’s veterinary commercialization partner, which is covering all costs associated with veterinary clinical development, successfully concluded the full study.
Vetbiolix already exercised its option to enter into a full in-license agreement with Can-Fite and is obligated to pay Can-Fite an upfront payment, milestone payments and royalties on sales upon regulatory approval, summing up to projected income of $325M to Can-Fite over the next 10 years.
The study looked at the effect of 90 days treatment with Piclidenoson at 100 µg/kg and 500 µg/kg twice daily orally in dog patients with osteoarthritis. Including all evaluable patients, the primary objective was the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire for the assessment of symptoms severity evaluated on dog’s mobility. The secondary objectives included Visual Analog Scale (VAS) for pain assessment by pet parents and Numerical Rating Score (NRS) for (i) lameness and (ii) pain assessment by the veterinarian. The study reached the primary and secondary endpoints with a dose and time dependent inhibitory effect of Piclidenoson on LOAD and VAS, together with a favorable trend on NRS scores, demonstrating significant improvement in clinical status and decrease in pain utilizing the 500 µg/kg dose.
The canine osteoarthritis market is projected to reach $3 billion by 2028.
There is a clear need in the market for a safe and effective canine osteoarthritis drug. Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs), which only treat symptoms and carry significant harmful side effects, and an injectable disease-modifying osteoarthritis drug (DMOAD) that targets the progression of the disease.
“The final data from the osteoarthritis study are very encouraging and this veterinary indication offers Can-Fite the opportunity to get Piclidenoson onto the market faster to benefit canine, and potentially contribute to near-term revenues. We are very pleased to work productively with the team at Vetbiolix.” stated Can-Fite VP of business Development Dr. Sari Fishman.
About Piclidenoson
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase III clinical study in psoriasis. 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 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 NASH 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: www.canfite.com.
About VETBIOLIX SAS
VETBIOLIX develops innovative products for the treatment and prevention of diseases affecting pets. VETBIOLIX has built a unique pipeline of First-in-class oral small molecules in-licensed (exclusive and worldwide license) from Human Biotech worldwide which will answer to veterinary unmet medical needs in periodontitis (VBX-1000; Cathepsin-K inhibitor), osteoarthritis (VBX-2000; Adenosin-A3 agonist) and gut motility disorders (VBX-3000; 5-HT4 agonist). VETBIOLIX focuses exclusively on clinical developments of its drug candidates: the company invests on (i) clinical proof of concept studies, (ii) CMC-Pharmaceutical developments, (iii) regulatory Pilot clinical studies and (iv) regulatory Pivotal clinical studies. Revenue generation of the company will be based on out-licensing and/or co-developments deals with the Veterinary Pharmaceutical Industry.
For more information please visit: https://www.vetbiolix.com
Contact: matthieu.dubruque@vetbiolix.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
midastouch017
8 months ago
Can-Fite Reports First Half 2024 Financial Results & Progress in Two Pivotal Phase III Clinical Studies
https://finance.yahoo.com/news/fite-reports-first-half-2024-121500188.html
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
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.
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.
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.
midastouch017
10 months ago
Improvement in Patient with Decompensated Liver Cirrhosis Upon Treatment with Namodenoson
Can-Fite BioPharma Ltd.
Liver cirrhosis treatment global market is estimated to reach $29.2 billion by 2030
Ramat Gan, Israel, July 01, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, announced today that a patient with liver decompensated cirrhosis who was treated with Namodenoson at the Soroka Medical Center in Israel under compassionate use showed an improvement in liver indices. This drug candidate is currently used in a pivotal Phase III study for patients with advanced liver cancer and a Phase IIb study for MASH (metabolic dysfunction-associated steatohepatitis).
Decompensated cirrhosis is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage. While some drugs can treat symptoms, there is no therapeutic approach that has shown efficacy in slowing disease progression.
In the past year Can-Fite has initiated a compassionate use program at the Soroka Medical Center, Beersheva, Israel, for the treatment of decompensated patients with Namodenoson. The first patient, a 63-year-old female with a history of decompensated primary biliary cirrhosis is now treated for one year with Namodenoson. Prior to the treatment with Namodenoson and despite best medical care for her underlying disease, she developed ascites and was admitted to the hospital with acute variceal bleeding. Currently, the patient shows improvement in liver function tests hematological parameters and FibroScan values and has not experienced any event of decompensation since starting treatment with Namodenoson. Namodenoson is known to induce liver protective effects in other liver pathologies, and Phase IIa data in patients suffering from MASH (metabolic dysfunction-associated steatohepatitis), responded positively to the drug, showing anti-inflammatory, anti-steatotic, and antifibrotic effects with a very favorable safety profile.
Ohad Etzion, MD, Director, Department of Gastroenterology and Liver Diseases at the Soroka Medical Center, Beer Sheva, Israel, the Investigator and Initiator of this study commented, “We were very much encouraged by the response of the first patient with decompensated liver cirrhosis who showed a rapid and sustained response to the drug with an improvement with liver indices. We plan to treat more patients and hopefully see an improvement of liver function in this devastating disease.
Decompensated cirrhosis is defined as an acute deterioration in liver function, with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage. While some drugs can treat symptoms, there is no therapeutic approach that has shown efficacy in slowing disease progression. An estimated 10.6 million people globally had decompensated cirrhosis in 2017, with few treatment options available aside from liver transplants if the decompensated cirrhosis has reached an advanced stage. Underscoring the need for an effective treatment, the American Liver Foundation states there are more people who need a liver than supply available, and some people can be on the wait list for a liver transplant for more than 5 years. The treatment of liver cirrhosis globally is estimated to become an approximately $29.2 billion market by 2031.
midastouch017
10 months ago
Can-Fite Received IRB Approval for the Treatment of Pancreatic Cancer with Namodenoson in a Phase IIa Study
https://finance.yahoo.com/news/fite-received-irb-approval-treatment-110000599.html
Namodenoson showed efficacy in pre-clinical models via a definitive molecular mechanism of action
PETACH TIKVA, Israel, June 10, 2024--(BUSINESS WIRE)--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 it received an approval from the Institutional Review Board (IRB) of Rabin Medical Center, a leading medical institution in Israel where the study will be conducted. The approved protocol has been submitted now to the Ministry of Health (MOH).
"This Phase IIa study is designed as an open-label one, enabling us to assess the safety and potential efficacy of Namodenoson in pancreatic cancer patients whose disease has progressed despite first-line treatment. Our positive Namodenoson data in pancreatic carcinoma experimental models together with the positive data in the Phase II advanced liver cancer study, with a patient showing overall survival of >7 years, encouraged us to initiate the current Phase IIa study," stated Can-Fite’s Medical Director Dr. Michael Silverman.
The protocol of the clinical study is CF102-222PC entitled: "A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma," ClinicalTrials.gov Identifier: NCT06387342.
The study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy or who refuse standard treatment. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this population. All patients will receive oral Namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).
The study will be conducted by Dr. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel.
Namodenoson recently received peer-reviewed recognition for its efficacy findings in pancreatic cancer including from the American Association of Cancer Research (AACR) which accepted Can-Fite’s study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/ß-catenin Signaling Pathway" for a poster presentation at the AACR Special Conference on Pancreatic Cancer, and from Biomolecules, a scientific journal focused on the function and mechanism of bioactive molecules, which published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/ß-catenin, NF-?B, and RAS Signaling Pathways."
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.
midastouch017
10 months ago
Can-Fite Updates on its Advanced Liver Cancer Pivotal Phase 3 Study
https://finance.yahoo.com/news/fite-updates-advanced-liver-cancer-110000128.html
Namodenoson granted Orphan Drug and Fast track status from the FDA
RAMAT GAN, Israel, June 05, 2024--(BUSINESS WIRE)--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 an update on the status of its oncological lead drug candidate, Namodenoson in the treatment of advanced liver cancer. The 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 the former Phase 2 study, conducted in patients with advanced liver cancer, Namodenoson prolonged survival, patients had good quality of life, and in two patients, clearance of peritoneal carcinomas have been reported. In addition, one patient had a long term complete response of more than 7 years.
Liver cancer designated as hepatocellular carcinoma (HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B. According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. The market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries.
The current double blind, placebo-controlled trial, known as LIVERATION, will enroll 450 patients diagnosed with advanced liver cancer (hepato-cellular carcinoma) and underlying Child Pugh B7 (CPB7) cirrhosis. Patients will be randomized to oral treatment with either 25 mg of Namodenoson or a matching placebo, in a ratio of 2:1 given twice daily as a second- or third-line treatment. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will also be assessed. An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated.
midastouch017
11 months ago
Can-Fite to Participate in Partnering Meetings at Bio International Convention 2024
https://finance.yahoo.com/news/fite-participate-partnering-meetings-bio-110000426.html
PETACH TIKVA, Israel, May 27, 2024--(BUSINESS WIRE)--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 announces that its VP of Business Development, Dr. Sari Fishman, will hold 23 partnering meetings with Biotech & Pharma companies, who showed interest in partnering with Can-Fite. The meetings will take place during the Bio International Convention 2024 in San Diego, USA, on June 3-6. https://convention.bio.org/registration?gad_source=1&gclid=Cj0KCQjwu8uyBhC6ARIsAKwBGpR1uawA2qpi9I2O3htc7bwxwiKsbpmP1IefbWC8KrkYc5njVnODEpYaAsWWEALw_wcB
Can-Fite currently has out-licensing and distribution deals with seven pharma companies across North America, Europe, and Asia, which include upfront and milestone payments. The Company’s growing slate of indications and advanced pipeline are attracting increased interest from additional potential partners that will attend the conference in San Diego. Focusing on its core expertise in clinical development, Can-Fite pursues a strategy of partnering with companies in specific geographic markets that specialize in pharmaceutical distribution and regional regulatory approval.
Can-Fite’s pipeline of indications includes the two small molecule orally bioavailable drugs, Piclidenoson positioned for the treatment of Psoriasis (Phase 3) and Namodenoson for the treatment of advance liver cancer (Phase 3), pancreatic cancer (Phase 2a) and MASH (Phase 2b).
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 of steatotic liver disease (SLD), 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.
midastouch017
11 months ago
Can-Fite: FDA Grants IND Clearance for Namodenoson to Treat MASH Patients in a Phase IIb Study
https://finance.yahoo.com/news/fite-fda-grants-ind-clearance-110000893.html
RAMAT GAN, Israel, May 09, 2024--(BUSINESS WIRE)--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 announces that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for Namodenoson, for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), for the Company’s ongoing Phase IIb clinical study.
Namodenoson is a small molecule orally bioavailable drug, targeting the A3 adenosine receptor, over-expressed on the surface of liver pathological cells in MASH but not normal cells. This potentially makes Namodenoson an ideal specific candidate for the treatment of MASH. Indeed, in a Phase IIa clinical study Namodenoson, has been shown to reduce hepatic steatosis, inflammation and fibrosis, with an excellent safety profile. Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and the IND approval by FDA will allow for the recruitment of patients in the US.
The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed MASH. The primary efficacy objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with MASH, as determined by a histological endpoint. Eligible subjects are randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg every 12 hours or a matching placebo for 36 weeks.
"The IND activation for the treatment of MASH patients with Namodenoson, opens the gate for the enrolment of US based patients and will contribute to the heterogeneity of the population of this study," said Motti Farbstein, Can-Fite CEO. " As we are already enrolling patients for this study, we hope that in the next few months, we will complete recruitment. We are committed to improve the lives of MASH patients and based on the efficacy of the drug in the Phase IIa study, we are proud to develop a new potential treatment to address this disease."
Rates of MASH are increasing in the United States in concert with increasing rates of obesity and diabetes and is estimated to affect 2-5% of adult Americans. By 2028, Vantage Market Research estimates the addressable pharmaceutical market for MASH will reach $21.9 billion in size. In March 2024, Madrigal Pharmaceuticals announced FDA approval of Rezdiffra (resmetirom) for the treatment of MASH with moderate to advanced liver fibrosis, potentially paving the way for more drugs that target this huge market.
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