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Revenues for the year ended December 31, 2022 were $0.81 million
[Pitiful revenues, hardly worth mentioning].
As of December 31, 2022, Can-Fite had cash, cash equivalents, and short-term deposits of $7.97 million as compared to $18.90 million at December 31, 2021. The decrease in cash during the year ended December 31, 2022 is due to Company’s operating activity. During January 2023, the Company raised approximately $6.80 million net.
[In other words an additional raise to be expected soon]
Can-Fite Reports 2022 Financial Results & Provides Clinical Update
March 30 2023 - 07:15AM
Business Wire
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced financial results for the year ended December 31, 2022.
2022 & Recent Corporate and Clinical Development Highlights Include:
PICLIDENOSON
Phase III COMFORT™ Psoriasis Trial Met Primary Endpoint – Patients receiving Piclidenoson 3mg demonstrated a statistically significant improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI) 75 response at week 16 of treatment. An excellent safety profile was recorded.
Pivotal Phase III Psoriasis Registration Plan for Piclidenoson Submitted to EMA – Can-Fite submitted a market registration plan to the European Medicines Agency (EMA) for Piclidenoson in the treatment of moderate to severe psoriasis. A submission to the U.S. Food and Drug Administration (FDA) will follow.
Developing Piclidenoson as a Topical Psoriasis Treatment – In a preclinical model, daily treatment with topical Piclidenoson significantly inhibited psoriasis as measured by PASI calculated based on observation of erythema, thickness, scaling, and a score of skin lesions. The topical treatment may serve as a complementary product to oral Piclidenoson.
Piclidenoson Advances as a Treatment for Osteoarthritis in Dogs – Vetbiolix, Can-Fite’s veterinary commercialization partner, achieved progress in the development of Piclidenoson for the canine osteoarthritis market projected to reach $3 billion by 2028. Vetbiolix is covering all costs associated with veterinary clinical development.
NAMODENOSON
Namodenoson Found to Significantly Inhibit Pancreatic Cancer in Preclinical Studies – Namodenoson was found to have a significant anti-cancer effect in pancreatic carcinoma as a monotherapy, as well as an additive effect when combined with gemcitabine, the standard-of-care chemotherapy for pancreatic cancer. Namodenoson’s excellent safety profile and its ability to directly inhibit the growth of pancreatic tumors present its potential as an effective drug for the treatment of this disease which has a 5-year survival rate of only 11% in the U.S. Can-Fite has filed a patent application that covers the use of Namodenoson for the treatment of pancreatic cancer.
The U.S. Patent and Trademark Office Granted Can-Fite a Patent for the Treatment of Liver Fibrosis – The invention titled “Method for Treating Fibrotic Liver Tissue Using CL-IB MECA” is a broad patent that addresses markets for the treatment of all advanced liver fibrosis indications. The patent opens an opportunity for much broader market needs which entail all clinical conditions with advanced liver fibrosis.
Ongoing Advanced Clinical Studies with Namodenoson:
Pivotal Phase III Liver Cancer Study for Namodenoson – Can-Fite’s pivotal Phase III liver cancer study for Namodenoson will enroll ~450 patients diagnosed with advanced hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to 1 or 2 other lines of therapy. The primary end point is overall survival. An interim analysis will be performed.
Phase IIb Namodenoson NASH Study – 140 subjects with biopsy-confirmed NASH will be enrolled in the Phase IIb multicenter, randomized, double-blind, placebo-controlled study. The primary objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo as determined by a histological endpoint. In a prior Phase IIa study, Namodenoson met its primary endpoint by reducing liver fat, inhibiting fibrosis, and demonstrating an anti-inflammatory effect.
Following Complete Response in a Patient with Advanced Liver Cancer Treated with Namodenoson:
Namodenoson Approved for Compassionate Use in Romania – Romania became the second country, following Israel, to approve Namodenoson for compassionate use in patients with advanced liver cancer. Namodenoson induced a complete response with disappearance of all metastases in a patient who was enrolled in Can-Fite’s prior Phase IIb liver cancer study. The patient is continuing treatment under the compassionate use program.
Patients with Decompensated Liver Cirrhosis Will Be Treated with Namodenoson Under Compassionate Use in Israel – Patients with decompensated cirrhosis, an advanced form of cirrhosis associated with liver failure for which there are no therapeutic options other than liver transplantation, will be treated with Namodenoson at the Soroka Medical Center in Israel under compassionate use. Decompensated cirrhosis is an advanced form of cirrhosis associated with liver that impacts an estimated 10.6 million people globally.
“With two Phase III indications advancing through our pipeline, we look ahead to the potential commercialization of our small molecule drugs, Piclidenoson and Namodenoson,” stated Can-Fite CEO Dr. Pnina Fishman. “Namodenoson in particular is showing the potential for efficacy across several indications from liver disease to pancreatic cancer. We remain focused and committed to bringing our safe, oral drugs to patients with unmet needs.”
Financial Results
Revenues for the year ended December 31, 2022 were $0.81 million, a decrease of $0.04 million, or 4.7%, compared to revenues of $0.85 million during the twelve months ended December 31, 2021. The decrease is considered to be not material.
Research and development expenses for the year ended December 31, 2022 were $7.76 million, a decrease of $2.09 million, or 21.2%, compared to $9.85 million for the year ended December 31, 2021. Research and development expenses for the year ended December 31, 2022 comprised primarily of expenses associated with the completion of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the treatment of advanced liver cancer and a Phase IIb study for NASH. The decrease is primarily due to the wrap up of the Phase III study of Piclidenoson for the treatment of psoriasis in 2022.
General and administrative expenses were $3.14 million for the year ended December 31, 2022, a decrease of $0.70 million, or 18.2%, compared to $3.84 million for the same period in 2021. The decrease is primarily due to the decrease in professional services and public and investor relations expenses. We expect general and administrative expenses will remain at the same level for 2023 and beyond.
Financial expense, net for the year ended December 31, 2022 was $0.07 million compared to financial income, net of $0.22 million for the same period in 2021. The decrease in financial income, net was mainly due to an increase in revaluation of our short-term investments which was offset by an increase in interest from short term deposits.
Can-Fite's net loss for the year ended December 31, 2022 was $10.17 million compared with a net loss of $12.61 million for the same period in 2021. The decrease in net loss was primarily attributable to a decrease in research and development expenses and a decrease in general and administrative expenses.
As of December 31, 2022, Can-Fite had cash, cash equivalents, and short-term deposits of $7.97 million as compared to $18.90 million at December 31, 2021. The decrease in cash during the year ended December 31, 2022 is due to Company’s operating activity. During January 2023, the Company raised approximately $6.80 million net.
The Company's consolidated financial results for the twelve months ended December 31, 2022 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, 2022, 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 10 Bareket Street, Kiryat Matalon, Petah-Tikva 4951778, Israel or by phone at +972-3-9241114.
Don't get overly excited, to date CANF has
indeed
Some regional deals have been already signed and *include upfront money*
interesting
Can-Fite to Conduct Meetings at the BIO-Europe Spring Conference with Pharma Companies Interested in Licensing and Distributing Piclidenoson and Namodenoson
https://finance.yahoo.com/news/fite-conduct-meetings-bio-europe-110000647.html
Some regional deals have been already signed and include upfront money, regulatory & sales milestones, and double digit royalties
PETACH TIKVA, Israel, March 16, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, announced today that Dr. Sari Fishman, the Company’s Vice President of Business Development, will participate in the BIO-Europe Spring® partnering conference in Basel, Switzerland from March 20 to 22, 2023. Dr. Fishman will conduct one-on-one meetings with a substantial number of potential partners interested in licensing and distribution arrangements for Can-Fite’s advanced-stage drug candidates Piclidenoson and Namodenoson.
Piclidenoson is headed into a pivotal Phase III trial following a successful Phase III which met its primary endpoint. Namodenoson is currently being evaluated in a Phase IIb study for the treatment of NASH after its successful Phase II and a pivotal Phase III study in liver cancer. Both are oral drugs with excellent safety profiles.
"Can-Fite’s strategy of out-licensing by specific indication and territory is an effective strategy to accelerate the distribution of our drugs upon approval, getting treatments to patients who need them," Dr. Fishman, Can-Fite’s VP of Business Development stated. "We are building upon distribution arrangements we already have in place in territories including Europe, Asia, and Canada. As our pipeline advances, we expect the value of our partnership agreements to continue to grow and be a source of non-dilutive funding and revenue."
Can-Fite to Treat Decompensated Liver Cirrhosis Patients with Namodenoson Under Compassionate Use Setting
https://finance.yahoo.com/news/fite-treat-decompensated-liver-cirrhosis-110000543.html
Liver organ shortage puts patients at risk of death from decompensated cirrhosis with no treatment options available
Liver cirrhosis treatment market is estimated to reach approximately $15 billion in the U.S. by 2030
PETACH TIKVA, Israel, March 13, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, announced today that patients with decompensated cirrhosis, an advanced form of cirrhosis associated with liver failure for which there are no therapeutic options other than liver transplantation, will be treated with Namodenoson at the Soroka Medical Center in Israel under compassionate use. This drug is currently used in a pivotal Phase III study for patients with advanced liver cancer and a Phase IIb study for NASH.
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.
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 in the U.S. is estimated to become an approximately $15 billion market by 2030.
Ohad Etzion, MD, Head, Hepatology Department at the Soroka Medical Center, Beer Sheva, Israel, the Investigator and Initiator of this study commented, "Given the evidence of Namodenoson’s clinical benefit in patients with decompensated cirrhosis for whom there is no accepted well established treatment, Namodenoson may give hope to this patient population in the compassionate use setting."
Compassionate use allows doctors and their patients the option of early access to investigational new drugs, under closely controlled and monitored circumstances, when a patient who is facing serious illness has exhausted all available treatment options.
Namodenoson’s unique characteristics of inducing hepato-protective effects make it suitable to treat patients with decompensated cirrhosis. In a Phase II study, Namodenoson was found to increase overall survival in advanced liver cancer patients defined as Child Pugh B7, known to suffer from cirrhosis. In a Phase IIa NASH study, Namodenoson met its primary efficacy endpoint showing positive activity manifested in anti-inflammatory, anti-steatotic, and antifibrotic effects with a very favorable safety profile.
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 non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.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 the COVID-19 pandemic and the Russian invasion of Ukraine; 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 24, 2022 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230313005284/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
This is NO news. Check how many times CANF
chewed this item ad nauseam.
IT IS INTERESTING stock drops significantly when good news you put out . unbelievable
Novel Approach to Treating Advanced Liver Cancer with Namodenoson Published in Leading Scientific Journal: 12-Month Survival of 44% for Namodenoson vs. 18% for Placebo
https://finance.yahoo.com/news/novel-approach-treating-advanced-liver-120000220.html
Namodenoson is being evaluated in a pivotal Phase III study
Namodenoson is approved for compassionate use in the treatment of liver cancer in Israel and Romania
PETACH TIKVA, Israel, February 14, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that Purinergic Signalling, a peer-reviewed scientific journal focused on molecules which target adenosine receptors, published an article titled "Targeting the A3 adenosine receptor to treat hepatocellular carcinoma: anti-cancer and hepatoprotective effects" authored by Can-Fite’s CEO Dr. Pnina Fishman and others.
The article includes a review of the novel approach for treating advanced liver cancer with Namodenoson, a small molecule orally bioavailable drug which specifically kills cancer cells and leaves normal liver cells unharmed. Efficacy and safety data are presented from Phase I and II human clinical studies. Treatment with Namodenoson resulted in longer overall survival in patients with advanced liver cancer as defined by Child Pugh B (CPB) stage in a statistically significant manner. The drug has shown to have a very favorable safety profile and exert a protective effect on liver cancer cells.
Currently, Namodenoson is being evaluated in a pivotal Phase III study. The study protocol has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) with 450 patients to be enrolled in Israel, Europe, and the U.S. An interim data analysis will be performed.
Namodenoson has been granted both Orphan Drug and Fast Track designations by the FDA and has received Orphan Drug status with the EMA.
"With Namodenoson, we are aiming to treat patients with the greatest need—those with advanced liver cancer CPB. Moreover, this category of patients are typically not enrolled by other clinical studies due to the severity of their disease," Dr. Fishman stated. "We are hopeful that Namodenoson’s novel approach may be effective in our current pivotal Phase III trial based on positive results in our prior Phase II study with this advanced liver cancer population. Additionally, we are highly encouraged by the case of a patient from the Phase II study who cleared all liver cancer and remains cancer-free for six years while treated with Namodenoson."
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 non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.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 the COVID-19 pandemic and the Russian invasion of Ukraine; 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 24, 2022 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230214005420/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
This scam still milking investors?
Can-Fite: Namodenoson Significantly Inhibits Pancreatic Cancer in Preclinical Studies—A Patent Has Been Filed
https://finance.yahoo.com/news/fite-namodenoson-significantly-inhibits-pancreatic-120000207.html
Data show significant anti-cancer effect in pancreatic carcinoma as a monotherapy and an additive effect when combined with gemcitabine, the standard-of-care chemotherapy for pancreatic cancer
Namodenoson’s excellent safety profile and its ability to directly inhibit the growth of pancreatic tumors present its potential as an effective drug for the treatment of this devastating disease which has a 5-year survival rate of only 11% in the U.S.
Can-Fite has filed a patent application that covers the use of Namodenoson for the treatment of pancreatic cancer
PETACH TIKVA, Israel, January 24, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that its anti-cancer drug Namodenoson significantly inhibits the growth of pancreatic carcinoma as a stand-alone treatment. In combination with the leading chemotherapy used in pancreatic cancer, gemcitabine, Namodenoson demonstrated a significant additive effect. These pre-clinical studies were conducted on advanced pancreatic carcinoma patient cells. Namodenoson’s molecular mechanism of action in pancreatic cancer involves the regulation of the NF-?B /I?B /STAT3-mediated pathway.
Namodenoson is currently being evaluated in a pivotal Phase III study in advanced liver cancer and has completely cleared cancer in an advanced liver cancer patient who remains cancer-free 6 years after starting treatment.
"Following Namodenoson’s successful results in advanced liver cancer, we continue to develop our oncology drug for the treatment of additional aggressive tumors including pancreatic cancer. There is a dire need for a safe and effective treatment for patients with pancreatic carcinoma where Namodenoson has an advantage due to its protective effects on the cardiovascular system, liver, and bone marrow," stated Can-Fite CEO Dr. Pnina Fishman "Our pre-clinical Namodenoson studies in pancreatic cancer, combined with the clinical data from liver cancer, may open the door for an effective and safe treatment in this devastating disease which accounts for nearly a half-million diagnoses and deaths each year."
Based on these findings, Can-Fite has filed a patent application that covers the use of Namodenoson for the treatment of pancreatic cancer.
The highest incidence rates for pancreatic cancer are in Asia, Europe, and North America. According to the American Society of Clinical Oncology (ASCO), in 2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease. The 5-year survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately $6.6 billion by 2030.
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.
The title 'Can-Fite BioPharma drugs "very close" to entering clinic.'
is not mine, not my words anyway, but those of the video creator.
What CANF is trying to do is would be parnters to market their
drugs after approval.
In the meantime CANF is diluting by offering shares at a discount.
I would not recommend anyone to invest in this company.
what do you mean by entering clinic ? without any income how long could the company last until it waits for the Approval of the FDA
and EMA for the approval of their drugs it might take years. secondly every time they put out a
PR how do you explain That
the price is really 50 cents it was never $40 it was $4 for a day.. its gonna go down until the day it goes up to feed off the day traders and goes back down... there is no short volume and no chance for dividends.. a lot of israeli scammers running these type of companies with one small building or office and very slow progress keeping investors holding onto losses..
Can-Fite BioPharma drugs "very close" to entering clinic.
The company must raise funds, there are expenses and almost no income.
first she does reverse split and now she is dillluting the shares j believe she once made an
offering to sell shares to raise money and now she is doing it again it doesn't sound right The stock is down over a dollar i hope this stock is legit and she is telling the truth about her medicine that helps psoriasis and the cancer news like this should raise the stock price
Can-Fite Announces $7.5 Million Concurrent Registered Direct Offering and Private Placement
https://finance.yahoo.com/news/fite-announces-7-5-million-140400387.html
PETACH TIKVA, Israel, January 11, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases ("Can-Fite" or the "Company"), today announced that it has entered into definitive agreements for the purchase and sale of 1,000,000 of the Company’s American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), at a purchase price of $5.50 per ADS, in a registered direct offering. In a concurrent private placement, Can-Fite has also agreed to issue and sell 363,637 of its ADS (or ADS equivalents in lieu thereof), at the same purchase price as in the registered direct offering. In addition, the Company has agreed to issue in the offerings unregistered Series A warrants to purchase up to an aggregate of 1,363,637 ADSs and Series B warrants to purchase up to an aggregate of 1,363,637 ADSs. Each ADS represents three hundred (300) ordinary shares, par value NIS 0.25 per share, of Can-Fite. The offerings are expected to close on or about January 13, 2023, subject to satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings.
The Series A warrants will have an exercise price $6.00 per ADS, will become exercisable immediately upon issuance and have a term of five and one-half years from the date of issuance and the Series B warrants will have an exercise price $5.50 per ADS, will become exercisable immediately upon issuance and have a term of 20 months from the date of issuance.
The gross proceeds from the offerings (without taking into account any proceeds from any future exercises of warrants), before deducting the placement agent's fees and other offering expenses payable by the Company, are expected to be approximately $7.5 million. Can-Fite intends to use the net proceeds for funding research and development and clinical trials and for other working capital and general corporate purposes.
The ADSs (or ADS equivalents) offered in the registered direct offering (but excluding the securities offered in the private placement and the ADSs underlying the warrants) are being offered and sold by Can-Fite pursuant to a "shelf" registration statement on Form F-3 (File No. 333-249063) originally filed with the U.S. Securities and Exchange Commission (the "SEC") on September 25, 2020 and declared effective by the SEC on October 9, 2020. The offering of the ADSs (or ADS equivalents) to be issued in the registered direct offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.
The securities issued in the private placement and the unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the unregistered ADSs, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.
The Company also has agreed to amend certain warrants to purchase up to an aggregate of 600,000 ADSs of the Company that were issued in December 2021 by reducing the exercise prices from $20.00 per ADS to $5.50 pr ADS.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
Can-Fite Submits Market Registration Plan to European Medicines Agency for Piclidenoson in the Treatment of Psoriasis; FDA Submission to Follow
https://finance.yahoo.com/news/fite-submits-market-registration-plan-120000262.html
As an oral treatment with an excellent safety and efficacy profile, Piclidenoson has potential for strong market position in $26 B psoriasis treatment market
PETACH TIKVA, Israel, January 10, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today it has submitted a market registration plan to the European Medicines Agency (EMA) for its lead drug candidate Piclidenoson in the treatment of moderate to severe psoriasis. A submission to the U.S. Food and Drug Administration (FDA) will follow.
Registration plans for both the EMA and FDA include final efficacy and safety results from Can-Fite’s successful COMFORT™ Phase III study and the protocol for the Company’s upcoming Phase III pivotal trial together with a request for registration advice from the regulators. Current chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data are also included.
Can-Fite recently reported topline results from its Phase III COMFORT™ study which met its primary endpoint with statistically significant improvement over placebo in psoriasis patients and an excellent safety profile for Piclidenoson. The Phase III COMFORT™ data point towards a better safety profile for Piclidenoson as compared to Otezla, the leading oral therapy for psoriasis on the market today, as Otezla induced: 1) gastro-intestinal adverse events in 6% of patients compared with 1% in patients treated with placebo or Piclidenoson; and 2) 9.9% nervous system disorders in the Otezla vs. 0.7% in the Piclidenoson treated patients.
"Piclidenoson’s clinical trial results to date demonstrate its highly favorable safety profile which is similar to placebo, superior to oral Otezla, and based on published studies, far superior to biologics. Efficacy results from the COMFORT™ study show Piclidenoson is most effective longer term and with the most severe cases, suggesting it can be a preferred choice for the safe and effective treatment of this chronic condition," stated Can-Fite’s Medical Director, Dr. Michael Silverman.
"This submission represents an important step toward the pivotal Phase III study and subsequent marketing approval of Piclidenoson," said Dr. Pnina Fishman, CEO & CSO of Can-Fite BioPharma. "Given Piclidenoson’s unique activity and safety profile, we believe the $26 billion psoriasis market where there is a need for a safe and efficacious drug is a meaningful commercial opportunity."
About Piclidenoson
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 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 the Phase III COMFORT™ Study
The COMFORTTM CF101-301PS, was a Phase III randomized, double-blind, placebo- and active-controlled study of the efficacy and safety of daily Piclidenoson (CF101) administered orally in patients with moderate-to-severe plaque psoriasis. The primary objectives of this study were to evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg twice daily (BID) in patients with moderate-to-severe plaque psoriasis, compared with placebo, as determined by the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) at Week 16 (superiority); and evaluate the safety of oral Piclidenoson in this patient population. The secondary objectives of this study were to evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg BID, compared with placebo, as determined by the proportion of subjects who achieve, respectively, PASI 50, Physician Global Assessment (PGA) score of 0 or 1, and improvement on the Psoriasis Disability Index (PDI) at Week 16 (superiority); evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg BID, compared with Otezla (apremilast), as determined by the proportion of subjects who achieve PASI 75, PGA score of 0 or 1, PASI 50, and improvement in PDI at Weeks 16 and 32 (non-inferiority); and evaluate the efficacy and safety data for Piclidenoson through the extension period of up to 48 weeks of treatment.
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 non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.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 the COVID-19 pandemic and the Russian invasion of Ukraine; 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 24, 2022 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230110005515/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Worries me when they start grabbing for straws like this.
CANF is seeking for partnerships (eg Company’s
veterinary commercialization partner Vetbiolix)
The sole reason for CANF to do the r/s is as
another Bio company (MDWD) declared and done:
why are they doing reverse stock split what is there reason would it be benecial for the share holders
Can-Fite Announces ADS Ratio Change
https://finance.yahoo.com/news/fite-announces-ads-ratio-change-213000730.html
PETACH TIKVA, Israel, December 30, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today that the Company will change the ratio of its American Depositary Shares (ADSs) to ordinary shares from one (1) ADS representing thirty (30) ordinary shares to a new ratio of one (1) ADS representing three hundred (300) ordinary shares. The ratio change will be effective on January 9, 2023.
For ADS holders, the ratio change will have the same effect as a one-for-ten reverse ADS split. On the effective date, each ADS holder will be required to exchange every ten (10) 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. There is no change to the Company's underlying ordinary shares, and the Company’s ADSs will continue to trade on the NYSE American under the symbol "CANF".
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 ten times the ADS price before the change.
I strongly suggest you read #msg-167382543
'Letter to shareholders', see what the company planned
and what they achieved (or not) so far.
I expect a Jan. 2023 letter to investors will be issued as
is practiced each and every year as of late thus perhaps
get a clearer picture of the companys plans and prospects.
Thanks and appreciate your response. What timeline are you refereeing to? 2024 0r 2025 for each indication? Tia
In the billions $$$, however there is a catch,
they are years away from approval, if at all.
What is the potential revenue from this drug for liver cancer? Tia
Can-Fite gains on study data for liver cancer therapy
Dec. 28, 2022 8:16 AM ETCan-Fite BioPharma Ltd. (CANF)
By: Dulan Lokuwithana, SA News Editor
Israel-based Can-Fite BioPharma (NYSE:CANF) added ~13% pre-market Wednesday after the company shared latest findings on its liver cancer therapy Namodenoson ahead of two investor conferences early next year.
An experimental oral therapy, Namodenoson is targeted at hepatocellular carcinoma, non-alcoholic fatty liver disease (NAFLD), and non-alcoholic steatohepatitis (NASH).
The update relates to its studies on hepatocellular carcinoma (HCC), the commonest form of cancer, where the market size is expected to reach $3.8B by 2027 in G8 countries, according to data from Delveinsight.
The company said that its presentation at the JP Morgan healthcare conference in January and at the BI0-CEO investor conference in February would include data to compare the response of liver cancer patients to those with the most advanced liver cancer HCC Child-Pugh B (CPB).
The presentation will also contain the latest data on a CPB patient who remains clear of cancer six years after Namodenoson therapy. Can-Fite’s (CANF) Phase 3 pivotal liver cancer study for Namodenoson is now open for enrollment.
In August, Can-Fite (CANF) shares gained after the company announced that Romania approved Namodenoson for compassionate use in advanced liver cancer.
Can-Fite Updates: Namodenoson Increases Survival for the Most Severe Patients with Advanced Liver Cancer
https://finance.yahoo.com/news/fite-updates-namodenoson-increases-survival-120000953.html
Results to be shared at Biotech Showcase during JP Morgan conference week in San Francisco and at BI0-CEO in New York
An advanced CPB liver cancer patient remains clear of cancer 6 years following treatment with Namodenoson
While CPB patients are typically excluded from liver cancer clinical studies due to low expected response rates, Namodenoson-treated CPB7 patients had statistically significant overall survival gain
PETACH TIKVA, Israel, December 28, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today provided an update on its clinical program for Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. A pivotal Phase III registration study is open for enrollment of the most advanced liver cancer patients. At two upcoming bio-partnering conferences, Can-Fite will be presenting the latest data comparing the response of liver cancer patients to those with HCC Child-Pugh B (CPB), the most advanced liver cancer. The Company will also share the latest findings on a CPB liver cancer patient who remains cancer-free 6 years after she began treatment with Namodenoson.
Can-Fite’s prior Phase II study showed that median overall survival in the CPB7 patient population was 6.8 months for those treated with Namodenoson as compared to 4.3 months for those treated with placebo. The < 1-year survival in the whole patient population was 32% in the namodenoson treated group vs. 14% (p= 0.058) in the placebo treated patients whereas in the CPB7 population 44% survival was found in the namodenoson treated group vs. 18% in the placebo treated one (p=0.028). An article published in the peer-reviewed journal Cancers regarding Can-Fite’s Phase II study reported on the fact that CPB patients are generally excluded from clinical studies due to their poor prognosis and low expected response rate and that as of July 2020, clinicaltrials.gov listed 110 enrolling/active Phase II or III clinical studies in advanced HCC, all of which excluded CBP patients, except for only two studies in addition to Can-Fite’s.
"There is a dire need for a safe and effective treatment for patients with advanced liver disease, defined as CPB7 where Namodenoson has an advantage with its liver protective effect," stated Can-Fite CEO Dr. Pnina Fishman "Our Phase III pivotal Namodenoson study is open for enrollment of CPB7 patients who have tried but not benefitted from other treatments on the market. We are optimistic that Namodenoson can help these patients based on the overall survival benefit already demonstrated in our Phase II study. At the upcoming bio-partnering conferences, we will be sharing extensive data that compares how the overall liver cancer population is treated, while the CPB patient population has few options and there are very few drug developers that will even allow them into their studies."
Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on its Phase III pivotal liver cancer study which is now open for enrollment. Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying CPB7 through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. 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 be assessed.
An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated. Namodenoson will be evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been or are no longer effective.
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. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries.
Conference Schedule:
Biotech Showcase: The Investor Conference for Innovators – San Francisco, Sari Fishman Ph.D. will participate.
Meeting Dates: January 9-11, 2023
Location: Hilton San Francisco Union Square
For more information to request a meeting please register here
BIO CEO & Investor Conference – New York, Motti Farbstein CFO will participate.
Meeting Dates: February 6-7, 2023
Location: New York Marriott Marquis
For more information to request a meeting please register here
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: CFBI) 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 non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.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 the COVID-19 pandemic and the Russian invasion of Ukraine; 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 24, 2022 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221228005179/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Multiple Shots On Goal: Can-Fite’s Late-Stage Clinical Pipeline Hits Positive Results
https://finance.yahoo.com/news/multiple-shots-goal-fite-stage-130000004.html
By Ernest Dela Aglanu, Benzinga
Israel --News Direct-- Can-Fite Biopharma
Multiple countries are approving Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) ’s Namodenoson for compassionate use in patients with advanced liver cancer.
These countries, including Romania and Israel, seem to have acknowledged Namodenoson’s high efficacy and good safety record with anti-inflammatory and anti-cancer effects — in line with Phase II and Phase III studies conducted by the company.
Namodenoson is an oral small molecule drug generically known as Cl-IB-MECA (2-chloro-N6-(3-iodobenzyl)-adenosine-5’- N-methyl-uronamide), a highly specific and selective agonist at the A3 adenosine receptor (A3AR).
According to Can-Fite, the drug has a potent anti-cancer effect, particularly against hepatocellular carcinoma, and anti-inflammatory activity demonstrated in pre-clinical animal models of liver inflammation and in a Phase IIa NASH study.
Interestingly, Namodenoson is not the only drug in the company’s pipeline that seems to be grabbing a lot of attention. Can-Fite is also conducting studies for Piclidenoson for treating psoriasis and CF602 for treating erectile dysfunction.
Can-Fite seems to have carved a niche for itself as an advanced clinical-stage drug development company with a platform technology designed to address multi-billion-dollar markets in the treatment of cancer, liver, and inflammatory disease.
Multiple Shots On Goal
The company’s lead drug candidate, Piclidenoson, recently reported topline results in a Phase III trial for psoriasis.
Namodenoson is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, is open for enrollment.
The drug 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.
Can-Fite says Namodenoson has shown proof of concept to potentially treat other cancers, including colon, prostate, and melanoma.
The company’s third drug candidate, CF602, reports suggest, has also shown efficacy in treating erectile dysfunction. These drugs, according to Can-Fite, have an excellent safety profile with experience in over 1,500 patients in clinical studies to date.
Late-Stage Clinical Development Pipeline
The company’s late-stage clinical pipeline seems to be ticking all the right boxes. For example, Can-Fite recently reported that if the Phase III pivotal (registration) study for liver cancer meets its primary endpoint, then Namodenoson can be approved to treat it.
The Phase III pivotal (registration) study for psoriasis, it added, is now being prepared based on successful results from the most recent Phase III study of Piclidenoson, which showed the drug is safe and effective.
Lastly, the Phase IIb NASH study is now enrolling and treating patients, following a successful Phase IIa study.
Clearance Of Cancer In Patients Treated With Namodenoson?
On October 25, the company reported that a patient, a 61-year-old woman with hepatocellular carcinoma (HCC), the most common form of liver cancer, and moderate hepatic dysfunction Child-Pugh B (CPB7), participated in Can-Fite’s prior Phase II study.
The patient was in the Namodenoson arm of the Phase II study and continued treatment with Namodenoson for five years under an Open Label Extension Program. Treatment is ongoing under a Compassionate Use Program established in Romania in August of 2022.
This case report demonstrates that treatment with Namodenoson can lead to a complete and durable response in patients with HCC and CPB7.
Current Out-Licensing Deals
Can-Fite has out-licensed its drugs to companies such as Cipher Pharmaceuticals Inc. (TSE: CPH) (Canada), China Medical System Holdings (HKG: 0867) (China), Kyongbo Pharmaceutical Co Ltd. (KRX: 214390) (South Korea), Gebro Pharma (Spain, Austria, and Switzerland), and Ewopharma (Central Eastern Europe).
The company has already received $20 million in upfront and milestone payments and expects $130 million in revenues based on regulatory and sales milestones.
About Can-Fite BioPharma Ltd.Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) 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 non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.
This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice.
Contact Details
Motti Farbstein
Motti@canfite.co.il
Company Website
https://www.canfite.com
Multiple Shots On Goal: Can-Fite's Late-Stage Clinical Pipeline Hits Positive Results
Ernest Dela Aglanu, Benzinga Contributor
December 13, 2022 7:51 AM | 4 min read
https://www.benzinga.com/general/biotech/22/12/30055839/multiple-shots-on-goal-can-fites-late-stage-clinical-pipeline-hits-positive-results
Multiple Shots On Goal: Can-Fite's Late-Stage Clinical Pipeline Hits Positive Results
Multiple countries are approving Can-Fite BioPharma Ltd.
CANF ’s Namodenoson for compassionate use in patients with advanced liver cancer.
These countries, including Romania and Israel, seem to have acknowledged Namodenoson’s high efficacy and good safety record with anti-inflammatory and anti-cancer effects — in line with Phase II and Phase III studies conducted by the company.
Namodenoson is an oral small molecule drug generically known as Cl-IB-MECA (2-chloro-N6-(3-iodobenzyl)-adenosine-5’- N-methyl-uronamide), a highly specific and selective agonist at the A3 adenosine receptor (A3AR).
According to Can-Fite, the drug has a potent anti-cancer effect, particularly against hepatocellular carcinoma, and anti-inflammatory activity demonstrated in pre-clinical animal models of liver inflammation and in a Phase IIa NASH study.
Interestingly, Namodenoson is not the only drug in the company’s pipeline that seems to be grabbing a lot of attention. Can-Fite is also conducting studies for Piclidenoson for treating psoriasis and CF602 for treating erectile dysfunction.
Can-Fite seems to have carved a niche for itself as an advanced clinical-stage drug development company with a platform technology designed to address multi-billion-dollar markets in the treatment of cancer, liver, and inflammatory disease.
Multiple Shots On Goal
The company’s lead drug candidate, Piclidenoson, recently reported topline results in a Phase III trial for psoriasis.
Namodenoson is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, is open for enrollment.
The drug 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.
Can-Fite says Namodenoson has shown proof of concept to potentially treat other cancers, including colon, prostate, and melanoma.
The company’s third drug candidate, CF602, reports suggest, has also shown efficacy in treating erectile dysfunction. These drugs, according to Can-Fite, have an excellent safety profile with experience in over 1,500 patients in clinical studies to date.
Late-Stage Clinical Development Pipeline
The company’s late-stage clinical pipeline seems to be ticking all the right boxes. For example, Can-Fite recently reported that if the Phase III pivotal (registration) study for liver cancer meets its primary endpoint, then Namodenoson can be approved to treat it.
The Phase III pivotal (registration) study for psoriasis, it added, is now being prepared based on successful results from the most recent Phase III study of Piclidenoson, which showed the drug is safe and effective.
Lastly, the Phase IIb NASH study is now enrolling and treating patients, following a successful Phase IIa study.
Clearance Of Cancer In Patients Treated With Namodenoson?
On October 25, the company reported that a patient, a 61-year-old woman with hepatocellular carcinoma (HCC), the most common form of liver cancer, and moderate hepatic dysfunction Child-Pugh B (CPB7), participated in Can-Fite’s prior Phase II study.
The patient was in the Namodenoson arm of the Phase II study and continued treatment with Namodenoson for five years under an Open Label Extension Program. Treatment is ongoing under a Compassionate Use Program established in Romania in August of 2022.
This case report demonstrates that treatment with Namodenoson can lead to a complete and durable response in patients with HCC and CPB7.
Current Out-Licensing Deals
Can-Fite has out-licensed its drugs to companies such as Cipher Pharmaceuticals Inc.
CPH
(Canada), China Medical System Holdings (HKG: 0867) (China), Kyongbo Pharmaceutical Co Ltd. (KRX: 214390) (South Korea), Gebro Pharma (Spain, Austria, and Switzerland), and Ewopharma (Central Eastern Europe).
The company has already received $20 million in upfront and milestone payments and expects $130 million in revenues based on regulatory and sales milestones.
This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice.
Can-Fite’s Partner Vetbiolix is Heading into a European Multicentric Clinical Trial with Piclidenoson for the Treatment of Pets’ Osteoarthritis
https://finance.yahoo.com/news/fite-partner-vetbiolix-heading-european-120000029.html
The canine osteoarthritis market is projected to reach $3 billion by 2028
PETACH TIKVA, Israel, December 08, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced progress achieved in the development of Piclidenoson for` the treatment of osteoarthritis in dogs by the Company’s veterinary commercialization partner Vetbiolix, which is covering all costs associated with veterinary clinical development. The canine osteoarthritis market is projected to reach $3 billion by 2028.
Vetbiolix completed dose-ranging pharmacokinetic (PK) studies in dogs and determined the optimal efficacy and safety dosage for its upcoming European multicentric clinical study. Piclidenoson was well tolerated, with the PK data proportional to dose. Pre-clinical studies were also conducted showing Piclidenoson has a very favorable safety profile.
Based on these data, Vetbiolix has designed a European Multicentric Clinical study protocol for dogs with osteoarthritis which has been approved by an ethical committee.
There is 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.
"As Piclidenoson advances into a European Multicentric Clinical study for canine osteoarthritis in 2023, we are hopeful that our lead drug candidate, which has produced very good safety and efficacy results in human autoimmune diseases, will do the same for dogs," stated Can-Fite CEO Dr. Fishman. "This veterinary indication offers Can-Fite the opportunity to get Piclidenoson onto the market faster to benefit canines, while also potentially contributing near-term revenues. We are very pleased to work productively with the team at Vetbiolix."
In June 2021, Can-Fite entered an agreement with Vetbiolix, a France-based veterinary biotech company, for the treatment of osteoarthritis in companion animals including dogs and cats. Vetbiolix has the exclusive right to Piclidenoson in the veterinary osteoarthritis market for two years, during which time Vetbiolix is conducting studies and covering all associated costs. If the efficacy study yields positive data and Vetbiolix exercises its option to obtain the license from Can-Fite, then Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval.
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: CFBI) 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 non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.
Can-Fite Reports Third Quarter 2022 Financial Results & Provides Clinical Update
https://finance.yahoo.com/news/fite-reports-third-quarter-2022-120000606.html
PETACH TIKVA, Israel, November 25, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced financial results for the quarter ended September 30, 2022.
Corporate and Clinical Development Highlights Include:
Complete Clearance of Cancer in a Patient Treated with Namodenoson was Presented at the AASLD Liver Meeting® – A poster titled "Complete Response Induced by Namodenoson, an A3 Adenosine Receptor Agonist, in a Patient with Advanced Hepatocellular Carcinoma" was presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® in November in Washington, D.C. The findings were published in the October 2022 supplement of HEPATOLOGY, a premier peer-reviewed journal in the field of liver disease. The poster detailed the patient, a 61-year-old woman with hepatocellular carcinoma (HCC), the most common form of liver cancer, and moderate hepatic dysfunction Child-Pugh B (CPB7), who participated in Can-Fite’s prior Phase II study. The patient was in the Namodenoson arm of the Phase II study and continued treatment with Namodenoson for 5 years under an open label extension program until the approval of a compassionate use program in Romania in August.
Namodenoson Approved for Compassionate Use in Romania to Treat Liver Cancer; Phase III Pivotal Global Study Open for Enrolment – Romania became the second country to approve Namodenoson for compassionate use in patients with advanced liver cancer. Can-Fite’s global pivotal Phase III liver cancer study for Namodenoson is open for enrollment of approximately 450 patients diagnosed with HCC and underlying CPB7 who have not responded to other approved therapies.
New Psoriasis Data from Phase III COMFORT™ Trial Show Superior Safety & Improved Efficacy – The latest findings on Piclidenoson, Can-Fite’s lead drug candidate, from its Phase III COMFORT trial were presented in September at the 31st European Academy of Dermatology and Venerology by Dr. Kim A. Papp, MD, a prominent thought leader in the treatment of psoriasis. In addition to the study meeting its primary endpoint of Piclidenoson’s superiority over placebo, the latest data showed that Piclidenoson had a significantly better tolerability profile than Otezla, the leading oral psoriasis treatment on the market today. GI-related adverse events were 1% for Piclidenoson vs. 6% for Otezla, nervous system disorders were 0.7% for Piclidenoson vs. 9.9% for Otezla and 3.3% for the placebo. The discontinuation rate was significantly higher for Otezla than for Piclidenoson. In achieving psoriasis disability index (PDI) response at week 32, Piclidenoson was comparable to Otezla. Patients treated with Piclidenoson showed an improving progressive response over time, a critically important finding given psoriasis is a chronic disease that may require long-term treatment.
Pivotal Phase III Psoriasis Registration Study is Under Preparation for Submission to FDA & EMA – The pivotal Phase III psoriasis study’s protocol is being developed in conjunction with Dr. Kim Papp, a Key Opinion Leader in dermatology and an investigator in the COMFORT study. Marketing registration plans including chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data are being prepared for submission to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for Piclidenoson in the treatment of moderate to severe psoriasis.
Safety Study of Piclidenoson for Osteoarthritis in Dogs Successfully Concluded, Efficacy Study to Commence - Following a successful safety study in dogs that explored dose-range safety and pharmacokinetics, Piclidenoson is set to enter efficacy studies in the treatment of canine osteoarthritis through a development and commercialization agreement signed with Vetbiolix, a France based veterinary biotech company. Vetbiolix is financially responsible for the clinical studies. The canine osteoarthritis market is projected to reach $3 billion by 2028 and regulatory approval pathways tend to be shorter than those required for humans.
"The latest Phase III findings for Piclidenoson are highly encouraging and inform the potential for a successful psoriasis registration study which will be conducted under both the FDA and EMA. A favorable outcome could mean marketing approval in two of the largest markets in the world," stated Can-Fite CEO Dr. Pnina Fishman. "While we have distribution agreements in place for Piclidenoson and Namodenoson in the treatment of psoriasis and liver cancer in certain European and Asian markets, we maintain full distribution rights for these late-stage assets in the U.S., the largest market in the world. We are strategically evaluating partnerships in the U.S. as we continue to forge ahead on each of our other indications including Namodenoson in NASH and Piclidenoson for canine osteoarthritis."
Financial Results
Revenues for the nine months ended September 30, 2022 were $0.61 million, a decrease of $0.04 million, or 6.1%, compared to $0.65 million for the nine months ended September 30, 2021. The decrease is considered to be not material.
Research and development expenses for the nine months ended September 30, 2022 were $5.31 million, a decrease of $1.44 million, or 21.3%, compared to $6.75 million for the nine months ended September 30, 2021. Research and development expenses for the nine months ended September 30, 2022 comprised primarily of expenses associated with the completion of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the treatment of advanced liver cancer and a Phase IIb study for NASH. The decrease is primarily due to the wrap up of the Phase III study of Piclidenoson for the treatment of psoriasis in 2022.
General and administrative expenses for the nine months ended September 30, 2022 were $2.31 million a decrease of $0.40 million, or 14.7%, compared to $2.71 million for the nine months ended September 30, 2021. The decrease is primarily due to the decrease in professional services and public and investor relations expenses. We expect that general and administrative expenses will remain at the same level through 2022.
Financial expenses, net for the nine months ended September 30, 2022 were $0.14 million compared to finance income, net of $0.31 million for the nine months ended September 30, 2021. The decrease in financial income, net was mainly due to revaluation of the Company’s short-term investment which in 2021 was recorded as income and in 2022 was recorded as expense.
Net loss for the nine months ended September 30, 2022 was $7.15 million compared with a net loss of $8.50 million for the nine months ended September 30, 2021. The decrease in net loss for the nine months ended September 30, 2022 was primarily attributable to a decrease in research and development expenses and a decrease in general and administrative expenses.
As of September 30, 2022, Can-Fite had cash and cash equivalents and short term deposits of $10.79 million as compared to $18.90 million at December 31, 2021. The decrease in cash during the nine months ended September 30, 2022 is due to the ongoing operations of the Company.
The Company's consolidated financial results for the nine months ended September 30, 2022 are presented in accordance with US GAAP Reporting Standards.
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
September
30,
December
31,
2022
2021
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
3,727
$
4,390
Short term deposit
7,071
14,512
Prepaid expenses and other current assets
1,752
929
Short-term investment
15
237
Total current assets
12,565
20,068
NON-CURRENT ASSETS:
Operating lease right of use assets
98
138
Property, plant and equipment, net
43
47
Total non-current assets
141
185
Total assets
$
12,706
$
20,253
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
September
30,
December
31,
2022
2021
Unaudited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
1,472
$
954
Current maturity of operating lease liability
48
53
Deferred revenues
818
818
Other accounts payable
458
905
Total current liabilities
2,796
2,730
NON-CURRENT LIABILITIES:
Long - term operating lease liability
26
71
Deferred revenues
2,456
3,070
Total non-current liabilities
2,482
3,141
CONTIGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of NIS 0.25 par value - Authorized: 5,000,000,000 shares at September
30, 2022 and December 31, 2021; Issued and outstanding: 815,746,293 shares as of
September 30, 2022 and December 31, 2021
60,654
60,654
Additional paid-in capital
93,475
93,275
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(147,828
)
(140,674
)
Total shareholders' equity
7,428
14,382
Total liabilities and shareholders’ equity
$
12,706
$
20,253
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share data)
Nine months ended
September 30,
2022
2021
Revenues
$
613
$
649
Research and development expenses
(5,309
)
(6,749
)
General and administrative expenses
(2,317
)
(2,714
)
Operating loss
(7,013
)
(8,814
)
Total financial income (expense), net
(141
)
317
Net loss
$
(7,154
)
$
(8,497
)
Basic and diluted net loss per share
$
(0.01
)
$
(0.02
)
Weighted average number of ordinary shares used in computing basic and
diluted net loss per share
815,746,293
515,918,123
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) 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 non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.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 the COVID-19 pandemic and the Russian invasion of Ukraine; 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 24, 2022 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221125005018/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Can-Fite: Positive New Data from it’s Phase III Psoriasis Study will be Presented Today at an Industry Expert Summit in Boston
(How many times can one squeeze the lemon?)
https://finance.yahoo.com/news/fite-positive-data-phase-iii-111500818.html
The Summit will host industry drug development experts, all in the dermatology arena, who will present their technologies, exchange views and look at potential collaborations and partnerships.
Phase III COMFORT study successfully met its primary efficacy endpoint with Piclidenoson showing a safety profile similar to placebo and better tolerated than Otezla® at the 6th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases in Boston
Piclidenoson set for upcoming pivotal Phase III registration trial
PETACH TIKVA, Israel, November 02, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today the Company’s CEO, Dr. Pnina Fishman, will deliver a presentation titled "Piclidenoson for the Treatment of Psoriasis: Clinical Development and Mechanism of Drug Action" at the 6th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases on November 2, 2022. The Summit takes place in Boston from November 1-3, 2022.
COMFORT™, a Phase III, multicenter, randomized, placebo- and active-controlled, double-blind study assessed the efficacy and safety of Piclidenoson in more than 400 adults with moderate to severe plaque psoriasis. Piclidenoson demonstrated a statistically significant improvement when compared with placebo as measured by the Psoriasis Area and Severity Index (PASI) 75 response and the Physician Global Assessment (PGA) response index calculated based on the Erythema + Infiltration + Desquamation. The study further showed that in patients with severe disease, Piclidenoson’s efficacy is similar to Otezla®, currently the top selling oral psoriasis drug. Piclidenoson’s safety profile in the study was similar to placebo and it was better tolerated than Otezla®.
The Summit will host industry drug development experts, all in the dermatology arena, who will present their technologies, exchange views and look at potential collaboration and partnerships.
About Piclidenoson
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 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.
This Company Is Racing Toward Providing Comfort And Safety To Millions Of Psoriasis Sufferers
https://www.benzinga.com/general/biotech/22/10/29435873/this-company-is-racing-toward-providing-comfort-and-safety-to-millions-of-psoriasis-sufferers
Mark Gilman, Benzinga Editor
October 27, 2022 8:49 AM | 3 min read
The competition between pharmaceutical company trials to help the 2% to 3% of the population suffering from chronic psoriasis is heating up.
Psoriasis is a chronic inflammatory skin disease caused by genetic disposition or environmental factors and is a burgeoning $16 billion global market, according to Prophecy Market Insights. Pharmaceutical companies are racing to develop new proprietary psoriasis pill options. Bristol-Myers Squibb Co. BMY just saw its stock soar on news of FDA approval of oral Sotykty, joining Amgen Inc.’s AMGN Otezla which has been the dominant oral pill for psoriasis.
But in addition to the expense of injectables and pills used to bring relief to people living with psoriasis, some of the pill options have so many side effects that many people have decided they aren’t worth ingesting.
Can-Fite’s Piclidenoson Shows Positive Trial Results
Another biotechnology company developing its own proprietary small-molecule drugs has presented new positive data from its Phase III COMFORT study that its Piclidenoson drug has shown a “statistically significant improvement over placebo in psoriasis patients.”
Dr. Kim A. Papp, a world-renowned dermatologist, presented the news from Israel-based Can-Fite BioPharma Ltd. CANF at the 31st European Academy of Dermatology and Venerology Congress. The company reports that Piclidenoson is now advancing into a Phase III psoriasis registration trial. Developed by Papp, the protocol will be submitted this year to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for market clearance.
Can-Fite is an advanced clinical-stage drug development company with a pipeline of proprietary drugs designed to help multibillion-dollar markets in treating inflammatory, cancer and liver diseases.
Among its Piclidensoson drug study findings, Can-Fite reported:
Its COMFORT Phase III study met its primary endpoint of superiority versus placebo at 16 weeks
Patients treated with Piclidenoson showed an improving progressive response over time
Piclidenoson demonstrated an excellent safety profile, overlapping the placebo-treated group.
Piclidenoson, a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule drug which is orally bioavailable, has an excellent safety profile demonstrating evidence of efficacy in Phase II clinical studies, according to Can-Fite.
"The safety results on Piclidenoson and its progressive effectiveness over the study period position it as unique among the current treatment options — especially given the chronic nature of psoriasis, which can necessitate long-term treatment,” Papp said.
Piclidenoson Versus Otezla
The Can-Fite study also found the discontinuation rate by patients taking Amgen’s Otezla was significantly higher than for Piclidenoson, based on what the company referred to as “a significantly better safety profile than Otezla including gastro intestinal-related adverse events that were only 1% for patients on Piclidenoson versus 6% for those on Otezla.” Nervous system disorders were also found to be 0.7% for people taking Piclidenoson compared to 3.3% for patients taking placebo and nearly 10% for those on Otezla.
In the study, Piclidenoson demonstrated a favorable safety profile, showing results were better than the placebo-treated group, as 25.5% of patients treated with placebo had a treatment-emergent adverse event compared to only 14.8% of patients treated with Piclidenoson.
The primary objective of the Can-Fite study was to evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg twice daily in patients with moderate-to-severe plaque psoriasis compared with a placebo.
Based on the results, analysts have set new price targets for Can-Fite, including Alliance Global Partners ($8.25), CG Capital ($6) and Dawson James Securities and H.C. Wainwright & Co. ($5).
For more information on Can-Fite BioPharma, visit www.canfite.com.
This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice.
Can-Fite: Findings Showing the Complete Clearance of Cancer in Patient Treated With Namodenoson Will Be Presented at the AASLD Liver Meeting®
https://finance.yahoo.com/news/fite-findings-showing-complete-clearance-110000692.html
Namodenoson is now in a global pivotal Phase III study for advanced liver cancer
PETACH TIKVA, Israel, October 25, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today that a poster entitled "Complete Response Induced by Namodenoson, an A3 Adenosine Receptor Agonist, in a Patient with Advanced Hepatocellular Carcinoma" will be presented at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® at 1:00 pm on Monday, November 7, 2022 in Washington, D.C. The findings are published, Abstract 4413, in the October 2022 supplement of HEPATOLOGY, a premier peer-reviewed journal in the field of liver disease published on behalf of the AASLD.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221025005244/en/
CT images of the tumor at baseline as well as 7 weeks and approximately 5 years after treatment initiation. (Photo: Business Wire)
Summary of Abstract:
The patient, a 61-year-old woman with hepatocellular carcinoma (HCC), the most common form of liver cancer, and moderate hepatic dysfunction Child-Pugh B (CPB7), participated in Can-Fite’s prior Phase II study. The patient was in the Namodenoson arm of the Phase II study and continued treatment with Namodenoson for 5 years under an Open Label Extension Program. Treatment is ongoing under a Compassionate Use Program established in Romania in August of 2022.
Highlights:
At baseline, computed tomography (CT) scans demonstrated a large HCC tumor in the context of multifocal disease at baseline. Two treatment cycles later (e.g., after approximately 7 weeks) CT demonstrated shrinkage of the tumor mass that was consistent with a partial response.
Within 4 years of treatment, disappearance of the tumor mass, ascites and peritoneal carcinomatosis was observed consistent with a complete response by RECIST 1.1 and mRECIST.
The patient’s alanine transaminase (ALT) and aspartate aminotransferase (AST) levels were elevated at baseline (68 U/L and 44 U/L, respectively), and normalized after 1 treatment cycle. Normal ALT and AST levels were maintained for 5 years.
Serum a-fetoprotein level was 47 ng/ml at baseline, declined to normal levels after 5 cycles of treatment, and reached 1.3 ng/mL at the time of complete response.
No treatment-emergent adverse events were reported.
At the time of reporting this case (5 years from treatment initiation), the response is ongoing as indicated by evaluation of liver functions and imaging studies.
Conclusion:
This case report demonstrates that treatment with Namodenoson can lead to a complete and durable response in patients with HCC and CPB7.
"A Complete Response of HCC in an advanced stage is rare, and we are pleased to report that under treatment with Namodenoson, this patient has now survived more the five years, returning to normal liver function with the disappearance of ascites and peritoneal carcinomatosis," stated Can-Fite CEO Dr. Fishman. "We look forward to sharing our findings on this case with the community of hepatologists at The Liver Meeting in order to advance scientific knowledge and bring to market safe and effective treatments for liver cancer."
Can-Fite’s pivotal Phase III study in patients with advanced liver cancer is open for patient enrolment and will recruit patients in Israel, the U.S., and five countries in Europe. If the study achieves its endpoint, the Company will be in a position to submit Namodenoson for approval with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Namodenoson has Orphan Drug Status with both the FDA and EMA and Fast Track Status with the FDA. A registration plan has been submitted to and accepted by the FDA.
The Liver Meeting, which takes place in Washington, D.C. from November 4 – 8, 2022, brings together clinicians, associates, and scientists from around the world to exchange information on the latest research, discuss new developments in liver treatment and transplantation, and network with leading experts in the field of hepatology.
The HCC drug market is expected to reach $3.8 billion in 2027 in the G8 countries according to DelveInsight.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated for two indications, as a second line treatment for hepatocellular carcinoma in a pivotal Phase III study, and as a treatment for non-alcoholic steatohepatitis (NASH) in a Phase IIb study. 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: CFBI) 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 non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.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 the COVID-19 pandemic and the Russian invasion of Ukraine; 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 24, 2022 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221025005244/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Can-Fite to Present its Phase IIb NASH Drug Candidate Namodenoson at Upcoming Conference
https://finance.yahoo.com/news/fite-present-phase-iib-nash-110000185.html
Currently enrolling Phase IIb NASH study following successful Phase IIa that met all efficacy and safety endpoints
PETACH TIKVA, Israel, October 13, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today the Company’s CEO Dr. Pnina Fishman will present its liver drug candidate, Namodenoson, at the H.C. Wainwright 6th Annual NASH Investor Conference and conduct one-on-one meetings with investors on October 17, 2022. The virtual conference will feature presentations by private and public companies and a panel discussion by several renowned key opinion leaders in the NASH field.
There is currently no U.S. FDA approved treatment for NASH, an addressable pharmaceutical market estimated to reach $35-$40 billion by 2025 driven by increasing incidence. NASH is the leading cause for liver transplants among women and the second leading cause overall in the U.S. Given the rate of increase, it is expected to become the leading indication for liver transplants in males as well.
Can-Fite is conducting a Phase IIb multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed NASH. The primary objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with NASH, 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.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated for two indications, as a second line treatment for hepatocellular carcinoma in a pivotal Phase III study, and as a treatment for non-alcoholic steatohepatitis (NASH) in a Phase IIb study. 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.
Can-Fite BioPharma Ltd. Interview to Air on Bloomberg U.S. on the RedChip Money Report(R)
https://finance.yahoo.com/news/fite-biopharma-ltd-interview-air-120000659.html
ORLANDO, FL / ACCESSWIRE / September 23, 2022 / RedChip Companies will air a new interview with Can-Fite BioPharma Ltd. (NYSE American:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, on The RedChip Money Report® on Bloomberg TV, this Saturday, September 24, at 7 p.m. Eastern Time (ET). Bloomberg TV is available in an estimated 73 million homes across the U.S.
Interview highlights:
In the exclusive RedChip Money Report interview, Can-Fite's CEO Dr. Pnina Fishman discusses the Company's Phase 3 trials for patients with Psoriasis and Liver Cancer, Can-Fite's drug pipeline, $100 million in milestone payments, and much more.
Access this interview in its entirety at https://canfinfo.com/interview_access
Can-Fite: New Phase III Psoriasis Data Showing Superior Safety & Improved Efficacy Presented by KOL Dr. Papp at the 31st European Academy of Dermatology
https://finance.yahoo.com/news/fite-phase-iii-psoriasis-data-110000596.html
Dr. Papp: "The safety results on Piclidenoson and its progressive effectiveness over the study period position it as unique among the current treatment options especially given the chronic nature of psoriasis which can necessitate long-term treatment."
Piclidenoson has a safety profile similar to placebo and is better tolerated than Otezla®
Efficacy of Piclidenoson is similar to Otezla in psoriasis patients with severe disease
PETACH TIKVA, Israel, September 12, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today that Dr. Kim A. Papp, MD, PhD, presented new data from the Company’s recently completed Phase III COMFORT™ study at the late-breaking news session of the 31st European Academy of Dermatology and Venerology (EADV) Congress. Can-Fite previously reported the COMFORT™ study met its primary endpoint with Piclidenoson showing a statistically significant improvement over placebo in psoriasis patients. Piclidenoson is advancing into a pivotal Phase III psoriasis registration trial. The protocol, which is being designed by Dr. Papp, will be submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for market clearance of Piclidenoson in the treatment of moderate to severe psoriasis.
The following is a summary of key findings presented at EADV on September 10, 2022 in Milan, Italy during Dr. Papp’s presentation titled "Treatment of plaque psoriasis with piclidenoson: Efficacy and safety results from a phase 3 clinical trial (COMFORT)":
The COMFORT™ Phase III study met its primary endpoint of superiority vs. placebo at 16 weeks, p=0.037
Patients treated with Piclidenoson showed an improving progressive response over time, and as psoriasis is a chronic disease that may require long-term treatment, this is an important finding
Piclidenoson demonstrated an excellent safety profile, overlapping that of the placebo-treated group.
Piclidenoson had a significantly better tolerability profile than Otezla, as GI-related adverse events were 1% for Piclidenoson vs. 6% for Otezla, nervous system disorders were 0.7% for Piclidenoson, 9.9% for Otezla and 3.3% for the placebo. The discontinuation rate was significantly higher for Otezla vs. Piclidenoson
In the secondary endpoint of achieving a PASI 75 response (representing a 75% reduction in psoriasis severity) at week 32, in the whole patient population, Piclidenoson was inferior to Otezla; however, in a sub-group analysis of patients who had PASI>25 (more severe psoriasis) at baseline, Piclidenoson had a comparable response to Otezla
In the secondary endpoint of achieving psoriasis disability index (PDI) response at week 32, Piclidenoson was comparable to Otezla
Dr. Papp commented, "The safety results on Piclidenoson and its progressive effectiveness over the study period position it as unique among the current treatment options especially given the chronic nature of psoriasis which can necessitate long-term treatment."
Dr. Papps’s presentation was based on a study co-performed by numerous dermatology investigators, in Europe, Israel, and Canada.
Based in Waterloo, Ontario, Canada, Dr. Papp has over 25 years’ experience as a Principal Investigator. Internationally renowned as a Key Opinion Leader in clinical research, Dr. Papp has conducted over 70 international dermatology studies on a wide range of dermatological disorders. The K. Papp Clinical Research center is considered one of the top clinical research centers in the world. Instrumental in improving and refining study designs, Dr. Papp has completed over 150 research studies on 50 compounds and has worked on new treatments that are now available and helping tens to hundreds of thousands of patients with their condition.
Dawson James Sticks to Their Buy Rating for Can-Fite BioPharma (CANF)
September 04 2022 - 08:15AM
Dawson James analyst Jason Kolbert maintained a Buy rating on Can-Fite BioPharma (CANF - Research Report) on September 1 and set a price target of $7.00. The company's shares closed last Friday at $0.87.According to TipRanks, Kolbert is an analyst with an average return of -2.2% and a 36.06% success rate. Kolbert covers the Healthcare sector, focusing on stocks such as Sorrento Therapeutics, Can-Fite BioPharma, and Daré Bioscience.Can-Fite BioPharma has an analyst consensus of Moderate Buy, with a price target consensus of $6.00.See today’s best-performing stocks on TipRanks >>The company has a one-year high of $2.60 and a one-year low of $0.78.
On August 29, 2022, Can-Fite BioPharma Ltd. (the “Company”) announced that it postponed its annual general meeting of shareholders (the “Annual General Meeting”), which was scheduled for the same day. Accordingly, the Company’s Annual General Meeting will be reconvened on Monday, September 5, 2022 at 3:00 p.m., Israel time at the Company’s offices located at 10 Bareket Street, Petach Tikva, Israel.
Unfortunately so, but was clear from prior financial results that CANF would be at this point.
Given the 3 million quarterly burn you mention, I would expect them latest to raise when they are at the 6 million remaining mark. However while on course towards the 6 million mark, by the time the next earnings are out in November that the waiting will just keeping ushering the price down. So in truth it would be best for them to raise earlier while the share price is nominally higher.
Hence I surmise, perhaps we see the raise before the end of this current quarter.
Again I will be keeping close watch. The products are good, and the M/C is low indeed with much upside on any real positive news.
Best,
Spidey
Hi Spideyboy,
Can-Fite Reports Second Quarter 2022 Financial Results & Provides Clinical Update
https://finance.yahoo.com/news/fite-reports-second-quarter-2022-110000012.html
PETACH TIKVA, Israel, August 25, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced financial results for the quarter ended June 30, 2022.
Corporate and Clinical Development Highlights Include:
Strong Balance Sheet - On June 30, 2022, Can-Fite had approximately $12.72 million in cash, cash equivalents, and short-term deposits.
Namodenoson Approved for Compassionate Use in Romania, Pivotal Phase III Liver Cancer Study Open for Enrollment – In August, Can-Fite announced Romania became the second country, following Israel, to approve Namodenoson for compassionate use in patients with advanced liver cancer. Namodenoson induced a complete response with disappearance of all metastases in a Romanian patient who was enrolled in Can-Fite’s prior Phase IIb liver cancer study, and the patient will now continue treatment under the compassionate use program. Can-Fite’s pivotal Phase III liver cancer study for Namodenoson is open for enrollment of approximately 450 patients diagnosed with hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to other approved therapies.
Phase III COMFORT™ Trial for Psoriasis Meets Primary Endpoint – Topline results were announced during the second quarter, and further data are expected in the coming weeks. Piclidenoson, Can-Fite’s lead drug candidate, successfully met its primary endpoint in the Phase III COMFORT trial in more than 400 adults with moderate to severe plaque psoriasis. At week 16, patients receiving Piclidenoson 3mg demonstrated statistically significant improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI) 75 response (representing a 75% reduction in psoriasis severity): Piclidenoson 3mg: 9.7% vs. placebo: 2.6% (P< 0.04). A linear increase in the response of patients to Piclidenoson was achieved along the study period, on week 48 reaching a PASI 50 response (50% reduction in psoriasis severity) in 90% of patients, a PASI 90 response (90% reduction in psoriasis severity) in 10% of patients, and Psoriasis Disability Index (PDI) improvement in 60% of patients.
Company to Submit FDA & EMA Registration Plans for Piclidenoson for the Treatment Psoriasis – Following the successful COMFORT study, Can-Fite is planning to submit its marketing registration plans to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for Piclidenoson in the treatment of moderate to severe psoriasis. The pivotal Phase III study’s protocol is being developed in conjunction with Dr. Kim Papp, a Key Opinion Leader in dermatology and an investigator in the COMFORT study. Current chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data will be submitted to the FDA and EMA along with the pivotal Phase III protocol and other supporting clinical pharmacology plans.
Data show Piclidenoson’s Superior Safety Profile and Higher Patient Compliance Compared to Otezla® - In July, Can-Fite announced that further analysis of the Phase III COMFORT data point toward a better safety profile for Piclidenoson as compared to Otezla, which induced gastrointestinal adverse events in 6% of patients compared with 1% in patients treated with placebo or Piclidenoson. Discontinuation of treatment amongst patients treated with Otezla was significantly higher compared to that of the Piclidenoson treated patients.
Piclidenoson Demonstrates Higher Efficacy in Patients with More Severe Disease – Also announced in July a sub-analysis of the efficacy data that divided patients into those who had PASI>25 (more severe psoriasis) and PASI<25 (less severe) at baseline revealed that patients who started with higher PASI values at entry benefitted more from treatment with Piclidenoson as compared to placebo.
NASH Patent Granted in Israel, Phase IIb Study is Ongoing – Patient enrollment is ongoing in Can-Fite’s Phase IIb study evaluating Namodenoson in 140 subjects with biopsy-confirmed NASH. Can-Fite was granted a patent for NASH titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation" in Israel, adding to the approximately 40 other countries in which the same patent has been issued.
Piclidenoson to Enter Clinical Trial for Osteoarthritis in Dogs - Through a development and commercialization agreement signed with Vetbiolix, a France based veterinary biotech company in June of 2021, Piclidenoson is set to enter a clinical trial for the treatment of osteoarthritis in dogs. This follows a successfully completed safety study in dogs exploring dose-range safety and pharmacokinetics. Piclidenoson was well tolerated, with the pharmacokinetic data proportional to dose. Vetbiolix is financially responsible for the clinical studies. The canine osteoarthritis market is projected to reach $3 billion by 2028.
"Positive data from our Phase III COMFORT study further supports our belief that Piclidenoson’s excellent safety profile, combined with its efficacy as compared to placebo, position it very favorably in the market for psoriasis patients who seek an oral drug that can be used long-term," stated Can-Fite CEO Dr. Pnina Fishman. "As we prepare for a Phase III registration trial for Piclidenoson in psoriasis, we are concurrently advancing our portfolio in several other indications with an aim toward monetizing our significant progress through distribution and collaboration agreements."
Financial Results
Revenues for the six months ended June 30, 2022 were $0.40 million, an increase of $0.01 million, or 2.7%, compared to $0.39 million for the six months ended June 30, 2021. The increase considered to be not material.
Research and development expenses for the six months ended June 30, 2022 were $3.27 million, a decrease of $0.54 million, or 14.2%, compared to $3.81 million for the six months ended June 30, 2021. Research and development expenses for the six months ended June 30, 2022 comprised primarily of expenses associated with the completion of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the treatment of advanced liver cancer and a Phase IIb study for NASH. The decrease is primarily due to lower costs incurred in 2022 associated with the two studies for Namodenoson and due to the wrap up of the Phase III study of Piclidenoson for the treatment of psoriasis in 2022.
General and administrative expenses for the six months ended June 30, 2022 were $1.57 million a decrease of $0.32 million, or 16.9%, compared to $1.89 million for the six months ended June 30, 2021. The decrease is primarily due to the decrease in professional services and public and investor relations expenses. We expect that general and administrative expenses will remain at the same level through 2022.
Financial expenses, net for the six months ended June 30, 2022 were $0.18 million compared to finance income, net of $0.20 million for the six months ended June 30, 2021. The decrease in financial income, net was mainly due to revaluation of the Company’s short-term investment which in 2021 was recorded as income and in 2022 was recorded as expense.
Net loss for the six months ended June 30, 2022 was $4.62 million compared with a net loss of $5.09 million for the six months ended June 30, 2021. The decrease in net loss for the six months ended June 30, 2022 was primarily attributable to a decrease in research and development expenses and a decrease in general and administrative expenses.
As of June 30, 2022, Can-Fite had cash and cash equivalents and short term deposits of $12.72 million as compared to $18.90 million at December 31, 2021. The decrease in cash during the six months ended June 30, 2022 is due to the ongoing operations of the Company.
The Company's consolidated financial results for the six months ended June 30, 2022 are presented in accordance with US GAAP Reporting Standards.
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
June 30,
December 31,
2022
2021
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
1,712
$
4,390
Short term deposit
11,015
14,512
Prepaid expenses and other current assets
1,823
929
Short-term investment
39
237
Total current assets
14,589
20,068
NON-CURRENT ASSETS:
Operating lease right of use assets
111
138
Property, plant and equipment, net
46
47
Total non-current assets
157
185
Total assets
$
14,746
$
20,253
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
June 30,
December 31,
2022
2021
Unaudited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
824
$
954
Current maturity of operating lease liability
47
53
Deferred revenues
818
818
Other accounts payable
464
905
Total current liabilities
2,153
2,730
NON-CURRENT LIABILITIES:
Long - term operating lease liability
40
71
Deferred revenues
2,661
3,070
Total non-current liabilities
2,701
3,141
CONTIGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of NIS 0.25 par value - Authorized: 5,000,000,000 shares at June 30, 2022 and December 31, 2021; Issued and outstanding: 815,746,293 shares as of June 30, 2022 and December 31, 2021
60,654
60,654
Additional paid-in capital
93,410
93,275
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(145,299)
(140,674
)
Total shareholders' equity
9,892
14,382
Total liabilities and shareholders’ equity
$
14,746
$
20,253
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share data)
Six months ended
June 30,
2022
2021
Revenues
$
409
$
398
Research and development expenses
(3,273)
(3,810
)
General and administrative expenses
(1,576)
(1,892
)
Operating loss
(4,440)
(5,304
)
Total financial income (expense), net
(185)
207
Net loss
$
(4,625)
$
(5,097
)
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
815,746,293
500,010,114
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) 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 has completed enrollment 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 non-alcoholic steatohepatitis (NASH), and a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.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 the COVID-19 pandemic and the Russian invasion of Ukraine; 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 24, 2022 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220825005061/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
I, as well, have invested in this up and coming biotech. It’s molecule is a first in class adenosine receptor agonist. Side effects are minimal compared to other classes of drugs intended to treat psoriasis.
Potentially, the drug could become first in line due to its safety profile.
If company fails I will consider it my contribution to the advancement of science.
Not a financial advisor, but I am comfortably parked here for a long time. I can see 2-3 years out, if we survive. Hopefully, indication for psoriasis in canines comes first, which I don’t expect to fail, providing much needed funds.
IMO
Spideyboy, you wrapped it up realistically
and very professionally.
Small wonder the sp is stuck where it is now.
My hope, perhaps more of a wishful thinking,
is that some BP will step forward with funds
thus avoiding near term dilution.
Time will tell.
Thank you for your learned opinion.
That would of course be something different entirely :)
Hi again Midas,
Regards this PR, I don't think there is anything new or particularly interesting to glean from it.
The key point in the PR is:
"Dr. Papp who is leading the design of Can-Fite’s pivotal Phase III psoriasis registration trial, which will be submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for market clearance of Piclidenoson in the treatment of moderate to severe psoriasis."
On this there are 2 things to see.
1. They are clearly designing the new Phase 3 Psoriasis study with Dr. Papp. So we are years off from getting an outcome on the psoriasis situation.
2. They appear to be stuck with their beefed up previous PR wording where to calm and I dare say confused sentiment, they keep adding in buzz wording about registration trial and submission to FDA and EMA to keep people thinking they are moving ahead with some sort of speed. However as we know this is not the case. First they will design, then recruit then get data read out, all of which will take years and plenty more money to get there in this indication.
The liver cancer study, while still being at least a year off, is the closest thing I see on the horizon.
If only USA would replace Romania for
the Compassionate Use Treatment,
the impact on sp would have been tenfold
or at least sparked some attention to a
would be BP parntership.
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