Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
When does the news break?
Hi Spideyboy,
I forsee an upcoming delay, however as
long as the results pass with flying colours,
i would not mind too much.
Fingers crossed.
Theoretically, just 2 days at most to see the Psoriasis data. See if they deliver on time
No new delay mentioned.
Will the MM manipulator criminals, and the izzraels be the typical toxic slobs like with many other stocks there,and kill the boner
Can-Fite’s CF602 Reverses Erectile Dysfunction in Diabetic Pre-clinical Model: Study Published in Peer-Reviewed Journal Andrologia
https://finance.yahoo.com/news/fite-cf602-reverses-erectile-dysfunction-110000468.html
CF602’s unique mechanism of action enables potential treatment of diabetic patients and may offer an alternative to PDE5 (Viagra, Cialis, Levitra, and Stendra) non-responders accounting for 30-35% of the $3.6 billion ED market
Patents granted in numerous healthcare markets including the U.S., Australia, and Japan
PETACH TIKVA, Israel, June 24, 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 its study titled "A3 adenosine receptor allosteric modulator CF602 reverses erectile dysfunction in a diabetic rat model" was published in the peer-reviewed journal Andrologia.
A full erectile recovery was achieved following a single dose of CF602 with restored muscle collagen ratio and endothelial cell function. Can-Fite’s CF602, an allosteric modulator of the A3 adenosine receptor (A3AR), applied topically or orally in a diabetic rat model, resulted in increased arterial blood flow and significant dose-dependent improvements in intracavernosal pressure (ICM), smooth muscle:collagen ratio, vascular endothelial growth factor and endothelial nitric oxide synthase.
While oral phosphodiesterase type 5 (PDE5) inhibitors are the current standard of care for erectile dysfunction (ED), with brands including Viagra, Cialis, Levitra, and Stendra, an estimated 30% to 35% of ED patients are non-responders, and these drugs can be contraindicated for people living with diabetes.
Data published in the article suggest CF602 could potentially offer an alternative treatment to PDE5 inhibitors, particularly to PDE5 non-responders and diabetics.
"There is a clear and unmet need in the market today for an effective alternative to PDE5 inhibitors for non-responders to the leading sexual dysfunction drugs and diabetics, many of whom cannot safely be prescribed PDE5 inhibitors. With a growing body of data and IP estate around CF602, we are evaluating potential strategic partnerships to advance CF602 toward market," stated Can-Fite CEO Dr. Pnina Fishman.
According to Zion Market Research, the global ED market was valued at $3.64 billion in 2021 and is projected to reach $5.94 billion by 2028.
About CF602
CF602 is a novel A3AR allosteric modulator that enhances the receptor activity in the presence of the native ligand. The molecule is characterized by high selectivity at the A3AR and is capable of avoiding receptor desensitization, thus magnifying the agonist activity at low doses.
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, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. 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. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. 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 risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the impact of the COVID-19 pandemic; 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; statements as to the impact of the political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220624005117/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Can-Fite is a global leader in the development of small molecule A3AR drugs with an ongoing Phase IIb NASH study, a pivotal Phase III liver cancer study open for enrollment, and topline data expected from a completed Phase III psoriasis study in Q2 2022
Can-Fite Announces Publication of Clinical Study Data for Piclidenoson and Namodenoson in Scientific Journal
https://finance.yahoo.com/news/fite-announces-publication-clinical-study-110000006.html
[url]Data suggest Piclidenoson and Namodenoson could potentially be the first A3AR agonists to achieve FDA approval and provide clinicians with new oral and safe drugs in the arsenal for fighting psoriasis, liver cancer, and NASH
Can-Fite is a global leader in the development of small molecule A3AR drugs with an ongoing Phase IIb NASH study, a pivotal Phase III liver cancer study open for enrollment, and topline data expected from a completed Phase III psoriasis study in Q2 2022[/url][tag]insert-text-here[/tag]
PETACH TIKVA, Israel, June 09, 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 an article titled "Drugs Targeting the A3 Adenosine Receptor: Human Clinical Study Data" was published in MDPI’s open access scholarly journal Molecules. The complete article can be accessed here: LINK
Can-Fite is a global leader in the development of small molecule A3 adenosine receptor (A3AR) technology with 15 patent families, extensive efficacy and safety data in over 1,500 patients, and three indications in Phase II and III studies.
In the scientific community, A3AR is well established as a target for combatting inflammation and cancer. The target, Gi protein-coupled A3AR, is highly expressed in inflammatory and cancer cells, but not in normal cells. High A3AR expression is also found in peripheral blood mononuclear cells (PBMCs) of patients with inflammatory diseases and cancer, reflecting A3AR expression in pathological remote sites. Solid tumor cells including breast, colon, small cell lung, pancreatic carcinoma, and melanoma, highly express A3AR compared to normal adjacent tissue cells. A3AR is also expressed in inflammatory cells such as synoviocytes derived from patients with rheumatoid arthritis, skin biopsies, and PBMCs from psoriasis and Crohn’s disease patients.
Targeting this receptor with synthetic and highly selective A3AR agonists induces anti-inflammatory and anti-cancer effects. Can-Fite’s patent estate provides broad coverage for its A3AR platform technology across numerous indications.
"As a leader in the development of A3AR targeting drugs, we are pleased to have this comprehensive article published in an open-source scientific journal. We believe providing data on our platform’s mechanism of action and its performance in several clinical studies supports the advancement of knowledge and discovery specific to A3AR and increases its potential to become a widely used mechanism to treat chronic and acute disease," stated Can-Fite CEO Dr. Pnina Fishman.
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, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. 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. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. 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 risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the impact of the COVID-19 pandemic; 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; statements as to the impact of the political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220609005293/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Indeed, any day now!
Fingers crossed!
And not a lot of it left, so I’d clarify by saying very interesting June!
Murocman
Should be a very interesting Q2
Can-Fite Reports First Quarter 2022 Financial Results & Provides Clinical Update
https://finance.yahoo.com/news/fite-reports-first-quarter-2022-110000598.html
PETACH TIKVA, Israel, May 26, 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 March 31, 2022.
Corporate and Clinical Development Highlights Include:
Fortified Balance Sheet - On March 31, 2022, Can-Fite had approximately $16.5 million in cash, cash equivalents, and short-term deposits.
Phase III Psoriasis Study Data Expected Q2 2022 – Topline results are expected in Q2 2022 in Can-Fite’s Phase III Comfort™ psoriasis study for both its 16 week primary endpoint and 32 week secondary endpoint. The study is designed to establish Piclidenoson’s superiority compared to placebo at 16 weeks and non-inferiority compared to Apremilast (Otezla®) at 32 weeks. During the first quarter, a preclinical study showed Piclidenoson destroyed pathological skin cells, offering further evidence of potential efficacy in psoriasis.
Developing Topical Psoriasis Treatment - In a preclinical model, daily treatment with topical Piclidenoson significantly inhibited psoriasis as measured by the psoriasis area severity index (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.
Commenced Enrollment in Phase IIb NASH Study – In January, Can-Fite enrolled the first patient in its Phase IIb multicenter, randomized, double-blind, placebo-controlled study in 140 subjects with biopsy-confirmed NASH. 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.
Granted U.S. Patent for Liver Fibrosis and Israeli Patent for NASH – The U.S. Patent and Trademark Office granted Can-Fite a patent for its invention titled "Method for Treating Fibrotic Liver Tissue Using CL-IB MECA", 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 including autoimmune hepatitis, primary biliary cirrhosis (PBC), nonalcoholic fatty liver disease (NAFLD), and alcoholic liver disease (ALD) among others. The Israel Patent Office granted Can-Fite a patent titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation" which has been issued in approximately 40 other countries.
Opened Enrollment in Pivotal Phase III Liver Cancer Study – Can-Fite’s pivotal Phase III liver cancer study for Namodenoson opened 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. An interim analysis will be conducted after 50% of patients are enrolled and treated. The primary endpoint is overall survival. Can-Fite has received Orphan Drug Designation in both the U.S. and Europe and has received the U.S. FDA’s Fast Track Status.
Presented Data on Cannabinoids in the Treatment of Liver Cancer at CannX – In March, Can-Fite delivered a presentation titled "Inhibition of Hepatocellular Carcinoma Growth and Liver Fibrosis by Nanomolar Cannabinoids Concentrations" at the CannX Medical Cannabis Conference in Tel Aviv. The findings were also published in the peer-reviewed scientific journal Medical Cannabis and Cannabinoids highlighting the ability of CBD-rich T3/C15 in nanomolar concentrations to inhibit the growth of hepatocellular carcinoma and liver stellate cells via A3AR activation and deregulation of the Wnt/ß-catenin pathway.
"We look forward to announcing Phase III psoriasis results before the end of the second quarter as we enroll patients in our other advanced stage clinical trials for NASH and liver cancer," stated Can-Fite CEO Dr. Pnina Fishman. "Can-Fite is financially well positioned to conduct all our clinical development programs over the next year, and we continue to evaluate potential new distribution partnerships which may provide additional non-dilutive funding."
Financial Results
Revenues for the three months ended March 31, 2022 were $0.20 million, an increase of $0.05 million, or 38.5%, compared to $0.15 million for the three months ended March 31, 2021. The increase in revenues was mainly due to the recognition of a higher portion of advance payments received under a distribution agreement with Ewopharma than the advance payment received at the end of the first quarter of 2021.
Research and development expenses for the three months ended March 31, 2022 were $1.82 million, an increase of $0.52 million, or 39.8%, compared to $1.30 million for the three months ended March 31, 2021. Research and development expenses for the first quarter of 2022 comprised primarily of expenses associated with an ongoing Phase III study of Piclidenoson for the treatment of psoriasis and two studies for Namodenoson, a Phase III study in the treatment of liver cancer and a Phase IIb study for NASH. The increase is primarily due to costs incurred in the first quarter of 2022 associated with the two new studies for Namodenoson.
General and administrative expenses for the three months ended March 31, 2022 were $0.75 million a decrease of $0.26 million, or 25.8%, compared to $1.01 million for the three months ended March 31, 2021. The decrease is primarily due to the decrease in professional services for public relations and investor relations. We expect that general and administrative expenses will remain at the same level through 2022.
Financial expenses, net for the three months ended March 31, 2022 were $0.06 million compared to finance income, net of $0.29 million for the three months ended March 31, 2021. The decrease in financial income, net was mainly due to revaluation of our short-term investment which in 2021 was recorded as income and in 2022 was recorded as expense.
Net loss for the three months ended March 31, 2022 was $2.43 million compared with a net loss of $1.87 million for the three months ended March 31, 2021. The increase in net loss for the three months ended March 31, 2022 was primarily attributable to an increase in research and development expenses which was partly offset by a decrease in general and administrative expenses and a decrease in finance income, net.
As of March 31, 2022, Can-Fite had cash and cash equivalents and short term deposits of $16.5 million as compared to $18.9 million at December 31, 2021. The decrease in cash during the three months ended March 31, 2022 is due to the ongoing operation of the Company.
The Company's consolidated financial results for the three months ended March 31, 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)
March 31, 2022
December 31, 2021
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
5,504
$
4,390
Short term deposit
11,016
14,512
Prepaid expenses and other current assets
971
929
Short-term investment
182
237
Total current assets
17,673
20,068
NON-CURRENT ASSETS:
Operating lease right of use assets
125
138
Property, plant and equipment, net
49
47
Total long-term assets
174
185
Total assets
$
17,487
$
20,253
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
March 31,
2022
December 31, 2021
Unaudited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
1,124
$
954
Current maturity of operating lease liability
55
53
Deferred revenues
818
818
Other accounts payable
907
905
Total current liabilities
2,904
2,730
NON-CURRENT LIABILITIES:
Long-term operating lease liability
54
71
Deferred revenues
2,865
3,070
Total Long-term liabilities
2,919
3,141
SHAREHOLDERS’ EQUITY
Ordinary shares of NIS 0.25 par value - Authorized: 5,000,000,000 shares at March 31, 2022 and December 31, 2021; Issued and outstanding: 815,746,293 shares as of March 31, 2022 and December 31, 2021
60,654
60,654
Additional paid-in capital
93,351
93,275
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(143,108
)
(140,674
)
Total equity
12,024
14,382
Total liabilities and equity
$
17,847
$
20,253
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share data)
Three months ended
March 31,
2022
2021
Unaudited
Revenues
$
205
$
148
Research and development expenses
(1,821
)
(1,303
)
General and administrative expenses
(754
)
(1,016
)
Operating loss
(2,370
)
(2,171
)
Total financial income (expense), net
(64
)
293
Net loss
(2,434
)
(1,878
)
Basic and diluted net loss per share
(0.00
)
(0.00
)
Weighted average number of ordinary shares used in computing basic and diluted net loss per share
815,746,293
483,920,313
Can-Fite Granted Key NASH Patent in Israel
https://finance.yahoo.com/news/fite-granted-key-nash-patent-110000203.html
Phase IIb NASH study is currently enrolling patients; Phase IIa met endpoints including reduced liver fat content
PETACH TIKVA, Israel, May 16, 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 that its patent titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation" has been granted by the Israel Patent Office.
This patent has been issued in approximately 40 countries and territories including Japan, South Korea, Hong Kong, Mexico, and in the European Union. It addresses the use of the A3 Adenosine Receptor (A3AR) ligand, the target receptor for Can-Fite's drug platform technology, for the treatment of ectopic fat accumulation particularly in fatty liver as manifested in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The treatment of NASH is a market estimated to reach $35 billion by 2025.
Can-Fite is currently enrolling and treating patients in a Phase IIb NASH study of its liver drug candidate Namodenoson. The multi-center, randomized, double blind, and placebo controlled study of biopsy-confirmed NASH patients will measure efficacy periodically through biomarkers, with a primary efficacy endpoint determined by liver biopsy at the end of the treatment period. In a prior Phase IIa study, Namodenoson met endpoints including reduced liver fat content, anti-inflammatory effects, and decreased body weight with excellent safety.
"The treatment of NASH is an enormous unmet need that Can-Fite seeks to meet through our advanced stage clinical trial and our expanding patent estate for the use of our target A3AR in the treatment of fatty liver disease," stated Can-Fite CEO Dr. Pnina Fishman.
Can-Fite’s CEO to Present Namodenoson’s Efficacy in Liver Cancer as Expert Speaker at the Adenosine Pathway Targeted Cancer Immunotherapy Summit
https://finance.yahoo.com/news/fite-ceo-present-namodenoson-efficacy-110000223.html
Namodenoson induced complete response and cleared all cancer lesions in advanced liver cancer patient in Phase II study
Phase III trial for the treatment of liver cancer is now open for the recruitment of
Pivotal patients
PETACH TIKVA, Israel, May 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, today announced the Company’s CEO Dr. Pnina Fishman has been invited as an expert speaker to deliver a presentation titled "Targeting the A3 Adenosine Receptor for the Treatment of Advanced Liver Cancer" at the Adenosine Pathway Targeted Cancer Immunotherapy Summit in Boston on May 12, 2022.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220502005267/en/
Radiological data show the disappearance of tumor lesions from a patient treated with Namodenoson who had advanced disease and fully recovered. (Graphic: Business Wire)
Namodenoson, a small orally bioavailable drug that specifically binds to the A3 adenosine receptor (A3AR), over-expressed in liver cancer but not normal cells, is headed into a Phase III liver cancer pivotal trial. The trial has received a green light from both the U.S. FDA and the European Medicines Agency (EMA) and is now open for the recruitment of approximately 450 patients diagnosed with hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to other approved therapies. A prior Phase II HCC study patient who continues to be treated with Namodenoson has survived more than five years and cleared all cancer lesions.
"Adenosine pathway targets have become one of the most clinically validated oncology pathways, further validating our A3AR target for the treatment of liver and other cancers. I’m pleased to be invited to speak and share Can-Fite’s experience with adenosine pathway drug development and clinical trials, and radiological data showing the disappearance of tumor lesions from a patient treated with Namodenoson who had advanced disease and fully recovered," stated Can-Fite CEO Dr. Pnina Fishman.
The inaugural Adenosine Pathway Targeted Cancer Immunotherapy Summit is dedicated to optimizing the efficacy of adenosine pathway targeted drugs, overcoming challenges of resistance and immunosuppression, and supercharging therapeutics into the clinic. The conference aims to maximize the clinical and commercial opportunity of the adenosine pathway as a second-generation immuno-oncology target.
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.
Can-Fite BioPharma (CANF) Receives a Buy from H.C. Wainwright
April 06 2022 - 06:25AM
TipRanks
In a report released today, Vernon Bernardino from H.C. Wainwright reiterated a Buy rating on Can-Fite BioPharma (CANF – Research Report), with a price target of $5.00. The company's shares closed last Tuesday at $1.24. According to TipRanks.com, Bernardino is a 5-star analyst with an average return of 27.9% and a 38.0% success rate. Bernardino covers the Healthcare sector, focusing on stocks such as Eledon Pharmaceuticals, Citius Pharmaceuticals, and Aridis Pharmaceuticals. Can-Fite BioPharma has an analyst consensus of Moderate Buy, with a price target consensus of $7.00, implying a 455.6% upside from current levels.
https://www.tipranks.com/news/blurbs/can-fite-biopharma-canf-receives-a-buy-from-h-c-wainwright-2?utm_source=advfn.com&utm_medium=referral
Hi Spidey,
Whew, you should have heard
my VERY LOUD sigh of relief
reading your post!
Thank you!
Looking forward to a fruitful
conference today, as well as
for the Phase III results to
be published soon!
Hi Midas,
This I don't believe is anything to be disappointed about. And even I take this in a positive light.
Psoriasis has different levels of severity. Feel free to watch the whole video as it is short, but can skip to minute 8:30.
CANF ended flat, not too far
from what i had expected.
Conference tomorrow!
Can-Fite reports positive data from preclinical trial of topical psoriasis treatment
Apr. 05, 2022 12:20 PM ETCan-Fite BioPharma Ltd. (CANF)
By: Dania Nadeem, SA News Editor
Can-Fite (NYSE:CANF) said it was developing a topical psoriasis treatment with its psoriasis oral drug candidate Piclidenoson.
The Company’s said that in a preclinical trial, daily treatment with topical Piclidenoson significantly inhibited the disease as measured by the psoriasis area severity index (PASI).
"The current preclinical data are important and serve as a basis for further development of a topical Piclidenoson treatment for psoriasis skin lesions, as it may serve as a good complementary product to our oral Piclidenoson drug," said Can-Fite CEO, Pnina Fishman.
CANF expects to report results from its Phase III oral Piclidenoson study in Q2.
The primary endpoint of the late-stage oral drug trial is the proportion of patients who achieve a PASI score response of ≥75% vs. placebo at week 16.
According to Persistence Market Research, topical psoriasis treatments account for 41.7% of the psoriasis drug market, which is valued at $11.37 billion in 2021, the company said.
Only thing I can think of is:
1. They want something they can have full control over, and a topical formulation might have broader appeal and maybe be available OTC?
It does seem very odd and quite presumptuous unless they know the results of the phase III, in which case they are obligated to report them.
It sure has the appearance of the “cart being in front of the horse”
Murocman
I do not understand the reason of
this PR at all.
Who needs a
'Potential Complementary
Product to its Phase III Oral Psoriasis Drug
Can-Fite is Developing a Topical Piclidenoson Psoriasis Treatment that Shows Efficacy in a Preclinical Model: Potential Complementary Product to its Phase III Oral Psoriasis Drug
https://finance.yahoo.com/news/fite-developing-topical-piclidenoson-psoriasis-110000789.html
Topical psoriasis treatments account for 42% of the $11.37 billion psoriasis drug market
Topline results from Phase III oral Piclidenoson study expected Q2 2022
Piclidenoson has been out-licensed for the systemic indication of psoriasis in certain major markets
PETACH TIKVA, Israel, April 05, 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 it is developing a topical psoriasis treatment with Piclidenoson, its Phase III psoriasis oral drug candidate. The Company’s scientists reported that in a preclinical model, imiquimod-induced skin psoriasis, daily treatment with topical Piclidenoson significantly inhibited the disease as measured by the psoriasis area severity index (PASI) calculated based on observation of erythema, thickness, scaling, and a score of skin lesions.
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule drug with a favorable therapeutic index demonstrated in Phase II clinical studies.
The Company expects to announce topline results during Q2 2022 from its Phase III randomized, double blind, active and placebo-controlled study conducted in Europe, Israel, and Canada. The study’s primary endpoint is the proportion of patients who achieve a PASI score response of ≥75% (PASI 75) vs. placebo at week 16 and secondary endpoints include non-inferiority vs. Otezla®.
"The current preclinical data are important and serve as a basis for further development of a topical Piclidenoson treatment for psoriasis skin lesions, as it may serve as a good complementary product to our oral Piclidenoson drug. We are encouraged by the positive interim analysis reported last year from our Phase III oral Piclidenoson study based on data from 200 patients, and we hope that the data will be reproducible, offering patients safe and long term relief from the symptoms of psoriasis," stated Can-Fite CEO Dr. Pnina Fishman.
According to Persistence Market Research, topical psoriasis treatments account for 41.7% of the psoriasis drug market which was valued at $11.37 billion in 2021 and is projected to grow at a CAGR of 6.5% to $21.48 billion by 2031.
Piclidenoson has been out-licensed for the indication of psoriasis in major markets including Canada, Europe, and Asia with deal terms including potential upcoming milestone payments and double-digit royalties upon regulatory approval.
News out. This thing just seems not able to hold any kind of spike at all.
Based on the conference PR, it is not at all clear to me that phase III results will be released.
Based on the conference PR, it is not at all clear to me that phase III results will be released. But hopefully we get enough of a “broadcast tease” with some specifics to generate some excitement.
GLTA,
Murocman
Hope for the best - prepare for the worst!
Myself, i am quite optimistic for the near
future, CANF.
I had the chance to get out of here twice in the past but my gain would have been less than a hundred bucks so I held.So maybe I can time it right on my 3rd try. Fingers crossed. lol
Hopefully some good news, or at
least some hints of the news to
come in 2 days time:
Can-Fite to Present at Dermatology
Drug Development Summit Europe on
April 6, 2022
I would add more now if I had the cash.
I would add more now if I had the cash.
If indeed the psoriasis results are
really outstanding, it just might
hop to $4.00 over that very
announcement alone.
Not too long a wait!
Fingers crossed.
Me to probably before that even. lol
LOL, by $5.00 i'll be long gone!
Target price $9.00 moderate price is $7.00 so someone has high hopes for this stock.
I held on PLX, today is my reward:
#msg-168433393
Is CANF next, i wonder?
We shall have the answer here in a couple of days. Would like to see it bust over $2.50 anyways on good news.
1.2700+0.0800 (+6.72%)
As of 11:04AM EDT. Market open.
Hinting on positive Psoriasis results to come?
Sure hope so!
1.3000 +0.06 (+4.84%)
Pre-Market: 08:17AM EDT
Momentum continues!
Can-Fite to Present at Dermatology Drug Development Summit Europe on April 6, 2022
https://finance.yahoo.com/news/fite-present-dermatology-drug-development-110000023.html
Phase III psoriasis topline data for Can-Fite’s lead drug candidate Piclidenoson expected Q2 2022
PETACH TIKVA, Israel, March 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 announced 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 3rd Annual Dermatology Drug Development Summit to leading European pharma and biotech industry stakeholders on April 6, 2022 at 4:30 pm in Frankfurt, Germany. The summit takes place April 6-7, 2022 and will focus on transformational new dermatological therapeutics being brought to market through collaboration.
Can-Fite completed enrollment in its Phase III Comfort™ study for the treatment of moderate-to-severe plaque psoriasis with 400 patients enrolled across 30 sites in Europe, Israel, and Canada. Topline data are expected in Q2 2022.
Piclidenoson has been out-licensed for the indication of psoriasis to distribution partners in Canada, China, Korea, and numerous countries in Eastern and Western Europe. Can-Fite has received approximately $20 million in upfront and milestone payments from out-licensing deals of its drug pipeline to date.
"We look forward to presenting Piclidenoson as a potentially safe and effective treatment for psoriasis to Europe’s dermatology thought leaders and potential collaborators in Frankfurt. Through Can-Fite’s agreements with Gebro Pharma and EwoPharma, Piclidenoson will have strong distribution and marketing channels, upon approval, in many European countries," Dr. Fishman stated. "Distribution rights for Piclidenoson are still available for some of the largest markets in Europe and we believe Dermatology Drug Development Summit, with its focus on collaboration, is a great venue to explore additional out-licensing partnerships."
Dawson James Keeps Their Buy Rating on Can-Fite BioPharma (CANF)
March 27 2022 - 08:15AM
Dawson James analyst Jason Kolbert maintained a Buy rating on Can-Fite BioPharma (CANF – Research Report) on March 25 and set a price target of $9.00. The company's shares closed last Friday at $1.20. According to TipRanks.com, Kolbert is a 3-star analyst with an average return of 2.5% and a 39.9% success rate. Kolbert covers the Healthcare sector, focusing on stocks such as Lineage Cell Therapeutics, Citius Pharmaceuticals, and Sorrento Therapeutics. Currently, the analyst consensus on Can-Fite BioPharma is a Moderate Buy with an average price target of $7.00.
https://www.tipranks.com/news/blurbs/dawson-james-keeps-their-buy-rating-on-can-fite-biopharma-canf?utm_source=advfn.com&utm_medium=referral
Annual and Transition Report (foreign Private Issuer) (20-f)
https://ih.advfn.com/stock-market/AMEX/can-fite-biopharma-CANF/stock-news/87645596/annual-and-transition-report-foreign-private-issue
1.1500+0.1300 (+12.75%)
At close: March 24 04:00PM EDT
1.2200 +0.07 (+6.09%)
After hours: 07:55PM EDT
Nice market reaction!
Can-Fite Biopharma GAAP EPS of -$0.03, revenue of $0.85M
Mar. 24, 2022 9:21 AM ETCan-Fite BioPharma Ltd. (CANF)
By: Deepa Sarvaiya, SA News Editor
Can-Fite Biopharma press release (NYSE:CANF): FY GAAP EPS of -$0.03.
Revenue of $0.85M (+11.8% Y/Y).
Can-Fite Reports 2021 Financial Results & Provides Clinical Update
https://finance.yahoo.com/news/fite-reports-2021-financial-results-123000547.html
Cash balance of $18.9 million as of December 31, 2021
Signed out-licensing deal worth $42.7 million with Ewopharma
Phase III psoriasis topline data expected Q2 2022
Namodenoson induced complete response and cleared all cancer lesions in advanced liver cancer patient in Can-Fite’s Phase II study
Phase IIb NASH study is currently enrolling patients
Pivotal Phase III advanced liver cancer study expected to commence enrollment for Namodenoson H1 2022
PETACH TIKVA, Israel, March 24, 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 year ended December 31, 2021.
Corporate and Clinical Development Highlights Include:
Fortified Balance Sheet – On December 31, 2021, Can-Fite had $18.9 million in cash, cash equivalents, and short-term deposits. During the year, the Company received $2.25 million in non-dilutive funding from Ewopharma for an out-licensing deal, $2.74 million from warrant exercises, and raised $10 million through a registered direct offering.
Signed Deal Worth $42.7 Million with Ewopharma – In 2021, Can-Fite signed its largest out-licensing agreement to date with Switzerland-based Ewopharma for distribution of its drug candidates in Central Eastern Europe and Switzerland. A $2.25 million upfront payment was received with up to an additional $40.45 million payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales. Together with Ewopharma, Can-Fite’s existing out-licensing deals are worth a potential $130 million in future milestone payments plus double-digit royalties on net sales upon regulatory approvals. Can-Fite has received over $20 million in non-dilutive funding to date.
Liver Cancer Patient Completely Cleared of Cancer; Pivotal Phase III Liver Cancer Study Expected to Commence Enrollment H1 2022 – A prior Phase II liver cancer study patient who continues to be treated with Namodenoson has survived five years and cleared all cancer lesions, in what the Company sees as a very positive sign for its upcoming pivotal Phase III liver cancer study. Enrollment is expected to commence H1 2022 with approximately 450 patients diagnosed with hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to other approved therapies.
Phase III Psoriasis Study Data Expected Q2 2022 – The Phase III Comfort™ study completed enrollment of >400 patients with moderate to severe plaque psoriasis and completed 16-weeks of treatment, the primary endpoint duration of the study. Topline results are expected in Q2 2022. The study is designed to establish Piclidenoson’s superiority compared to placebo at 16 weeks and non-inferiority compared to Apremilast (Otezla®) at 32 weeks. In a recently completed preclinical study, Piclidenoson destroyed pathological skin cells, offering further evidence of potential efficacy in psoriasis.
Phase IIb NASH Study Commenced Enrollment – This Phase II multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed NASH enrolled its first patient in January. 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. In a prior Phase IIa study, Namodenoson met its primary endpoint by reducing liver fat, inhibiting fibrosis, and demonstrating an anti-inflammatory effect. There is currently no U.S. FDA approved treatment for NASH, an addressable pharmaceutical market estimated to reach $21.9 billion by 2028 driven by increasing incidence.
Several Patents Granted for Liver Diseases – Can-Fite’s IP for Namodenoson in the treatment of liver diseases continues to grow. The Company was issued a Notice of Allowance in the U.S. for a broad patent that addresses markets for the treatment of all advanced liver fibrosis indications including NASH, NAFLD, autoimmune hepatitis, primary biliary cirrhosis, and more. Other patents specific to NASH and NAFLD were granted in 37 countries, most recently issued and allowed in Japan, Hong Kong, and Mexico.
A3AR-based Cannabis Compounds Found to Inhibit Liver Cancer Growth in Preclinical Study – Can-Fite continues to advance its findings for cannabinoids and its platform technology’s target A3AR for which the Company has filed a patent. In 2021, Can-Fite completed pre-clinical studies demonstrating that a CBD rich T3/C15 cannabis fraction induces inhibition of liver cancer cell growth. These findings were published in peer-reviewed journals and presented at industry conferences.
"Our advanced-stage pipeline continues to achieve milestones, with Piclidenoson and Namodenoson both positioned as potentially safe and effective treatments for very large treatment indications including psoriasis, NASH, and liver cancer. In 2021 we signed our largest out-licensing deal to date, and in 2022 we anticipate additional new agreements as well as the potential of milestone payments from current agreements based on results from our current advanced stage trials," stated Can-Fite CEO Dr. Pnina Fishman.
Financial Results
Revenues for the year ended December 31, 2021 were $0.85 million compared to revenues of $0.76 million during the twelve months ended December 31, 2020. The increase in revenues was mainly due to the recognition of a portion of an advance payment received under the Ewopharma distribution agreement entered in 2021 which was offset by the recognition of a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.
Research and development expenses for the year ended December 31, 2021 were $9.85 million compared to $11.95 million for the year ended December 31, 2020. Research and development expenses in 2021 comprised primarily of expenses associated with two studies for Piclidenoson, a Phase III study in the treatment of psoriasis and a Phase II study in COVID-19 and Phase II studies for Namodenoson in the treatment of liver cancer and NASH. The decrease is primarily due to costs incurred in 2020 associated with the Univo research project which was completed by the end of that year and a Phase III study of Piclidenoson for the treatment of rheumatoid arthritis which was ongoing during 2020, partially offset the pre-clinical projects and the two ongoing studies of Piclidenoson. We expect research and development expenses will increase through 2022 and beyond.
General and administrative expenses were $3.84 million for the year ended December 31, 2021 compared to $2.95 million for the same period in 2020. The increase is primarily due to the increase in salaries and related benefits due to the distribution of bonuses to employees, increase in employee salaries, increase in public relations expenses, and insurance expenses. We expect general and administrative expenses will remain at the same level for the remainder of 2022 and beyond.
Financial income, net for the year ended December 31, 2021 was $0.23 million compared to financial expense, net of $0.3 million for the same period in 2020. The decrease in financial expense, net was mainly due to an increase in the revaluation of our short-term investment.
Can-Fite's net loss for the year ended December 31, 2021 was $12.6 million compared with a net loss of $14.4 million for the same period in 2020. The decrease in net loss was primarily attributable to a decrease in research and development expenses which were partly offset by an increase in general and administrative expenses and a decrease in finance income, net.
As of December 31, 2021, Can-Fite had cash, cash equivalents, and short-term deposits of $18.9 million as compared to $8.3 million at December 31, 2020. The increase in cash during the year ended December 31, 2021 is due to an aggregate of $2.74 million in net proceeds received through warrant exercise transactions during the first quarter of 2021, an advance payment of $2.25 million from a distribution agreement with Ewopharma and from a $10 million registered direct offering in August 2021 which were offset by the Company’s operating activity.
The Company's consolidated financial results for the twelve months ended December 31, 2021 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, 2021, 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.
Can-Fite stock rises 8% on notice of allowance of patent for liver drug
Mar. 14, 2022 8:56 AM ETCan-Fite BioPharma Ltd. (CANF)
By: Ravikash, SA News Editor
Can-Fite BioPharma (NYSE:CANF) said it received a notice of allowance from the U.S. Patent and Trademark Office (PTO) related to its drug Namodenoson (CL-IB-MECA) to treat liver fibrosis.
The company said its invention is titled “Method for Treating Fibrotic Liver Tissue Using CL-IB MECA”.
The company said currently, namodenoson is being developed for liver cancer and NASH.
Can-Fite added that the allowance granted opens the door for much broader market needs which entail all clinical conditions with advanced liver fibrosis including autoimmune hepatitis, primary biliary cirrhosis, nonalcoholic fatty liver disease, and alcoholic liver disease, among others.
CANF +8.25% premarket to $1.05
Can-Fite: Namodenoson’s Treatment of Liver Fibrosis Receives Notice of Allowance from U.S. Patent Office
https://finance.yahoo.com/news/fite-namodenoson-treatment-liver-fibrosis-110000226.html
Broad patent addresses markets for the treatment of all advanced liver fibrosis indications
PETACH TIKVA, Israel, March 14, 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 it has received a Notice of Allowance from the U.S. Patent and Trademark Office (PTO) for its invention titled "Method for Treating Fibrotic Liver Tissue Using CL-IB MECA".
Currently, Namodenoson (CL-IB-MECA) is being developed for two liver indications, liver cancer and NASH. The allowance granted by the US PTO opens the door for much broader market needs which entail all clinical conditions with advanced liver fibrosis including autoimmune hepatitis, primary biliary cirrhosis (PBC), nonalcoholic fatty liver disease (NAFLD), and alcoholic liver disease (ALD) among others. The global liver disease treatment market was valued at approximately $20 billion in 2020 by Allied Market Research.
Can-Fite is currently enrolling patients in a Phase IIb trial of Namodenoson for the treatment of NASH, an advanced non-alcoholic fatty liver disease, for which there is no U.S. FDA approved treatment. Additionally, the Company expects to commence enrollment in a pivotal Phase III study of Namodenoson in the treatment of advanced liver cancer (hepatocellular carcinoma CPB7).
Can-Fite’s robust IP portfolio includes patents that address NASH and liver cancer, issued in approximately 40 countries. Namodenoson has been out-licensed in select countries for the treatment of NASH and liver cancer with agreements that include upfront and milestone payments.
"This U.S. patent is a very important addition to our growing IP portfolio in liver diseases. It is very well timed with our Phase IIb NASH study and Phase III liver cancer trial. Both are high value indications in which our robust patent portfolio and Namodenoson’s safety and efficacy profile position Can-Fite for potential additional strategic distribution deals worldwide," stated Can-Fite CEO Dr. Pnina Fishman.
About NASH
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. The U.S. National Institutes of Health estimate the prevalence of NASH in the U.S. at 2-5% of the population. NASH is the leading cause for liver transplants among women and 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.
About HCC
Hepatocellular carcinoma (HCC) is the most common form of liver cancer. HCC with underlying Child Pugh B7 (CPB7) is one of the most advanced forms of liver cancer. More than 800,000 people are diagnosed with liver cancer annually and approximately 700,000 die of the disease each year, according to the American Cancer Society. The HCC drug market is projected to reach $3.8 billion by 2027.
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.
Can-Fite’s Findings in the Treatment of Liver Diseases with Cannabinoids to be Presented at CannX Medical Cannabis Conference in Tel Aviv
https://finance.yahoo.com/news/fite-findings-treatment-liver-diseases-120000198.html
Can-Fite will conduct 1x1 meetings with companies in the cannabis field regarding potential collaboration
PETACH TIKVA, Israel, March 11, 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 that the Company’s CEO, Dr. Pnina Fishman, will deliver a poster presentation titled "Inhibition of Hepatocellular Carcinoma Growth and Liver Fibrosis by Nanomolar Cannabinoids Concentrations" at the CannX Medical Cannabis Conference in Tel Aviv which takes place March 14 – 15, 2022. The abstract will additionally be published in the peer-reviewed scientific journal Medical Cannabis and Cannabinoids. Can-Fite will conduct 1x1 meetings with companies in the cannabis field regarding potential licensing and partnership opportunities.
Cannabinoids bind to CB1 and CB2 receptors regulating the function of multiple organs and tissues of the body. Interestingly, cannabinoids also bind to Can-Fite’s platform technology’s primary target, the Gi protein associated A3 adenosine receptor (A3AR) which is up-regulated in inflammatory and tumor cells.
Can-Fite’s extensive body of research shows that A3AR agonists can knock down inflammation and cancer via the specific induction of apoptosis in these cells.
The study findings to be presented at CannX and published in Medical Cannabis and Cannabinoids highlight the ability of CBD-rich T3/C15 in nanomolar concentrations to inhibit the growth of hepatocellular carcinoma and liver stellate cells via A3AR activation and de-regulation of the Wnt/ß-catenin pathway.
"These findings open a novel therapeutic opportunity in liver cancer and fibrosis with minute CBD concentrations and low content of psychotropic THC fraction," stated Dr. Fishman. "We have filed patent applications on our discovery of cannabinoid-based therapies where the A3AR target is overexpressed including in liver cancer."
Can-Fite BioPharma Flags Delay In Piclidenoson Data Readout From Psoriasis Study
https://finance.yahoo.com/news/fite-biopharma-flags-delay-piclidenoson-133505014.html
Citing unanticipated delay in the collection of study data, Can-Fite BioPharma Ltd (NYSE: CANF) said that the topline data from its Phase 3 Comfort study of Piclidenoson in severe plaque psoriasis would be released in Q2 2022.
Earlier, the data were anticipated in Q1 of 2022.
The study enrolled more than 400 patients across 30 sites in Europe, Israel, and Canada.
Piclidenoson is an A3 adenosine receptor agonist (A3AR) small molecule that inhibits interleukin-17 and interleukin-23, both pivotal for the formation of skin lesions.
Piclidenoson has also recently been shown to induce the death of pathological skin cells.
The Comfort study's primary endpoint is the proportion of patients who achieve a PASI score response of ≥75% (PASI 75) vs. placebo at week 16. Secondary endpoints include non-inferiority to Amgen Inc's (NASDAQ: AMGN) Otezla (apremilast).
Can-Fite’s Phase III Psoriasis Study Data Expected Q2 2022
https://finance.yahoo.com/news/fite-phase-iii-psoriasis-study-120000787.html
PETACH TIKVA, Israel, March 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 that top line data from its Phase III Comfort™ study of Piclidenoson in the treatment of moderate-to-severe plaque psoriasis are scheduled to be released in Q2 2022 due to an unanticipated delay in the collection of study data. The study enrolled more than 400 patients across 30 sites in Europe, Israel, and Canada.
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a mechanism of action involving inhibition of 2 cytokines, interleukin-17 and interleukin-23, both pivotal for the formation of skin lesions. Piclidenoson has also recently shown to induce death of pathological skin cells.
The Comfort randomized, double blind, active and placebo-controlled study’s primary endpoint is the proportion of patients who achieve a PASI score response of ≥75% (PASI 75) vs. placebo at week 16, and secondary endpoints include non-inferiority to Otezla®, a leading oral drug on the market, at week 32. Piclidenoson is administered twice daily orally.
"While we had been expecting to announce topline results in the first quarter of 2022, it is taking longer than expected to gather and tabulate the data from this 400-plus person international study. We now expect to report results in the second quarter of 2022. We look forward to analyzing the data and are hopeful that Piclidenoson may prove to be an effective treatment with minimal to no side effects in the $11 billion psoriasis market," stated Can-Fite CEO Dr. Pnina Fishman.
Otezla reported generating $2.2 billion in sales in 2020. According to iHealthcareAnalyst, the psoriasis therapeutic market is estimated to reach $11.3 billion by 2025. Piclidenoson has been out-licensed for the indication of psoriasis in major markets including Canada, Europe, and Asia with deal terms including potential upcoming milestone payments and double-digit royalties upon regulatory approval.
CANF: Beginning to Flex Its Muscles; Initiating with OUTPERFORM Rating, $6.00 Price Target
by Can-Fite BioPharma, Contributor
February 24, 2022 1:09 PM | 3 min read
https://www.benzinga.com/amp/content/25808959
Summary
We are CORRECTING our initiating coverage of Can-Fite BioPharma Ltd. (“Can Fite” or the “company”), a clinical-stage pharmaceutical company, with an OUTPERFORM rating and $6.00 price target (CORRECTION from the previous, initiated $2 price target). With a pipeline of proprietary small molecule drugs treating inflammation, cancer and liver diseases, we believe Can-Fite is poised to register material progress in commercializing its compounds in 2022, including the imminent release of Phase III trial data for the treatment of psoriasis. Further, with a business model predicated on licensing compounds to leading international pharmaceutical players, we believe new contracts and territory expansion will refocus investors on Can-Fite’s myriad positives. As such, we view the risk/reward in CANF as impressive and are initiating coverage with an OUTPERFORM rating and a $6.00 price target.
Key Points
Focused on A3 adenosine receptor (“A3AR”). A3AR has a high incidence in cancer and inflammatory cells, which allows the company’s compounds to target A3AR and destroy the corresponding cells. Given the low expression of A3AR in normal cells, Can-Fite’s proprietary products have demonstrated high levels of safety.
Demonstrating efficacy: First up, psoriasis. The Phase III COMFORT study, which is designed to test Can-Fite’s Piclidenoson compound superiority in treating moderate to severe plaque psoriasis (versus the placebo) and non-inferiority compared to Amgen’s Otezla®®, was completed in January 2022. We expect 120M release of the data, which is set for 1Q22, to be a material catalyst. Psoriasis is a projected $40 billion + market.
Next in cue: Compounds to combat Hepatocellular Carcinoma (“HCC”) and Nonalcoholic steatohepatitis (“NASH”), a type of non-alcoholic fatty liver disease (“NAFLD”). Can-Fite’s second key compound, Namodenoson, is focused on treating HCC (liver cancer) and NASH. After a successful Phase II trial for HCC, Can-Fite is preparing to launch a Phase III Liver cancer study in 1Q22; the liver cancer market is estimated at approximately $3.8 billion.
In January 2022, Can-Fite enrolled their first patient for a Phase IIb trial to test the efficacy and safety of Namodenoson in treating NASH, a growing disease for which there is currently no FDA approved treatment, The market size is projected to be approximately $35 billion by 2025.
Erectile disfunction, cannabis and animal osteoporosis treatments are all in preclinical development.
Can-Fite business models sharesrisks,still offers impressive rewards. Can-Fite is entirely focused on achieving approval for its compounds. The company licenses the commercialization of its compounds for specific territories and ailments, which includes up front and milestone payments and a double-digit royalty rate. Given that there are still crucial territories unpartnered (United States, Western Europe, United Kingdom, Ireland, Japan among others) we see the signing of future licensing deals as key catalysts.
Strong, effective management team.
We project the company will need approximately $10 million in incremental financing in 2023, via either equity offerings or milestone/new territory licensing expansion.
Our Discounted Cash Flow model registers a CANF value of $7.09. We have conservatively projected only Piclidenoson for psoriasis receives regulatory approval in the projected time period and have assumed further dilutive equity raises.
Intracoastal Capital, Llc cuts stake in CANF / Can-Fite Biopharma Ltd.
https://fintel.io/news/intracoastal-capital-llc-cuts-stake-in-canf-can-fite-biopharma-ltd-0.2596377703529189
Fintel Staff
February 11, 2022
US:CANF
Intracoastal Capital, Llc cuts stake in CANF / Can-Fite Biopharma Ltd.
Intracoastal Capital, Llc has filed a 13G/A form with the Securities and Exchange Commission (SEC) disclosing ownership of 39,495,437 shares of Can-Fite Biopharma Ltd. (CANF). This represents 4.99 percent ownership of the company. In their previous filing dated January 29, 2021, the investor reported owning 32,911,650 shares and 6.60 percent of the company, indicating an increase in shares of 20.00 percent and a decrease in total ownership of 24.39 percent. The investor has filed 5 13D or G filings since April 11, 2019.
Top holders of Can-Fite Biopharma Ltd. sourced from 13F and NPORT filings include:
• Armistice Capital, Llc with 875,000 shares (0.11% ownership)
• Morgan Stanley with 196,675 shares (0.02% ownership)
• Cetera Advisor Networks LLC with 130,776 shares (0.02% ownership)
• Renaissance Technologies Llc with 93,405 shares (0.01% ownership)
• Fifth Third Bancorp with 30,000 shares (0.00% ownership)
• Acadian Asset Management Llc with 28,601 shares (0.00% ownership)
• Stifel Financial Corp with 12,000 shares (0.00% ownership)
• National Bank Of Canada /fi/ with 6,000 shares (0.00% ownership)
• Citigroup Inc with 5,535 shares (0.00% ownership)
• Wells Fargo & Company/mn with 1,500 shares (0.00% ownership)
Institutional sentiment is bullish.
There are 15 funds or institutions reporting positions in Can-Fite Biopharma Ltd.. This represents an increase of 2 owner(s) and 15.38 percent in the last three months. Average portfolio weight dedicated to Can-Fite Biopharma Ltd. is 0.0016 percent, an increase of 310.2301 percent in the last three months. Total shares owned by institutions increased in the last three months by 227.13 percent to 1,467,977 shares.
Followers
|
67
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
2043
|
Created
|
10/11/12
|
Type
|
Free
|
Moderators midastouch017 |
| |||
| |||
| |||
| |||
|
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |