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Can-Fite stock rises 23% as psoriasis drug beats placebo but lags behind Otezla in phase 3 trial
Jun. 29, 2022 8:40 AM ETCan-Fite BioPharma Ltd. (CANF)AMGN
By: Ravikash, SA News Editor
Can-Fite BioPharma's (NYSE:CANF) oral drug piclidenoson helped reduce severity of symptoms compared to placebo, but failed to beat Amgen's (AMGN) Otezla in adult patients with moderate to severe plaque psoriasis in a phase 3 trial.
Plaque psoriasis causes dry, itchy, raised patches (plaques) on the skin.
The study, dubbed COMFORT, included more than 400 adults and evaluated piclidenoson 2-mg or 3-mg twice daily, against placebo.
The company said piclidenoson 2-mg or 3-mg, had clinically equivalent efficacy responses and at week 16, patients receiving the 3-mg dose showed statistically significant improvement in severity of disease compared to placebo, as measured by the Psoriasis Area and Severity Index (PASI) 75 response (Piclidenoson 3mg: 9.7% vs. placebo: 2.6%). PASI 75 indicates a 75% or greater reduction in PASI scores from the time treatment started.
However, when compared to Amgen's (AMGN) Otezla, piclidenoson showed inferiority with respect to change in severity, or PASI, at week 32, which was the secondary goal to beat. PASI 75 (17% for piclidenoson vs. 26.2% for Otezla).
"Based on Piclidenoson’s safety and efficacy data revealed in this trial, we plan to approach the U.S. FDA and the European EMA with a protocol for a pivotal Phase III study for drug approval and registration,” stated Can-Fite CEO Pnina Fishman.
The company noted that piclidenoson was superior to Otezla in the Psoriasis Disability Index (PDI), a questionnaire measuring health-related quality of life, (20.5% for piclidenoson versus 10.3% for Otezla).
Can-Fite noted that piclidenoson had an excellent safety profile overlapping that of placebo and was better when compared to Otezla.
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Let's see how the market reacts to these data.
“superiority of Piclidenoson as compared to Otezla in the Psoriasis Disability Index (PDI) (20.5% vs. 10.3%, respectively, P<0.05).”
I like it. I like it a lot.
IMO
"Based on Piclidenoson’s safety and efficacy data revealed in this trial, we plan to approach the U.S. FDA and the European EMA with a protocol for a pivotal Phase III study for drug approval and registration," stated Can-Fite CEO, Dr. Pnina Fishman.
Can-Fite Announces Positive Top-Line Results from Piclidenoson Phase III COMFORT™ Study in Moderate to Severe Psoriasis
https://finance.yahoo.com/news/fite-announces-positive-top-line-110000545.html
Phase III COMFORT™ study met its primary endpoint with statistically significant improvement and Piclidenoson had an excellent safety profile
Can-Fite has licensing deals for the marketing of Piclidenoson for the treatment of Psoriasis in multiple global regions
PETACH TIKVA, Israel, June 29, 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 positive top-line results from the COMFORT™ trial, a Phase III, multicenter, randomized, placebo- and active-controlled, double-blind study to assess the efficacy and safety of Piclidenoson in more than 400 adults with moderate to severe plaque psoriasis.
The study data show that patients treated with oral Piclidenoson 2 mg or 3 mg twice daily, had clinically equivalent efficacy responses. 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: Piclidenoson 3mg: 9.7% vs. placebo: 2.6% (P< 0.04). Secondary endpoint parameters at week 32 comparing Piclidenoson to the active control drug, Otezla, revealed inferiority with respect to PASI 75 (17% vs. 26.2%, respectively) and PASI 50 (34.1% vs. 49.5%, respectively), but revealed superiority of Piclidenoson as compared to Otezla in the Psoriasis Disability Index (PDI) (20.5% vs. 10.3%, respectively, P<0.05). A linear increase in the response of patients to Piclidenoson was achieved along the study period, on week 48 reaching PASI 50 in 90% of patients, PASI 90 in 10% of patients and PDI improvement in 60% of patients.
Piclidenoson had an excellent safety profile overlapping that of the placebo treated patients, showing a better safety profile when compared to Otezla.
"Based on Piclidenoson’s safety and efficacy data revealed in this trial, we plan to approach the U.S. FDA and the European EMA with a protocol for a pivotal Phase III study for drug approval and registration," stated Can-Fite CEO, Dr. Pnina Fishman.
Dr. Michael T Goldfarb, MD, dermatologist and attending physician, Beaumont Hospital, Dearborn, Michigan, who has performed numerous psoriasis clinical trials over the last 38 years, commented, "Psoriasis causes skin inflammation, which impacts quality of life for patients. Our aim is to support more patients in achieving control of their symptoms, and especially using drugs with a good safety profile in this chronic disease which may require lifelong treatment. The clinically meaningful improvements seen in this trial, in both skin symptoms and quality of life, underline the highly favorable therapeutic index of Piclidenoson in psoriasis. Taken together, the results of the COMFORT™ trial strengthen our belief that oral Piclidenoson can address important unmet needs for patients with psoriasis, where the goal is an efficacious drug with an excellent safety profile to treat this chronic and devastating disease."
Full results from the COMFORT™ Phase III study will be presented at an upcoming medical conference and published in a peer-reviewed medical journal.
Can-Fite has five out-licensing deals for marketing and distribution of Piclidenoson for the treatment of psoriasis in markets including Canada, Eastern Europe, Central Europe (Austria, Swiss, Spain), China, and South Korea.
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 COMFORT™ CF101-301PS, is 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 are 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 are 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.
Been in this a long time. Any news at all doesnt seem to go far with this ticker.
that will be important
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.
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
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. 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.
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).
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