Welcome to our dedicated page for Can-Fite BioPharma Ltd. news (Ticker: CANF), a resource for investors and traders seeking the latest updates and insights on Can-Fite BioPharma Ltd. stock.
Can-Fite BioPharma Ltd. (CANF) is a clinical-stage biotechnology company whose news flow centers on the development of orally administered small-molecule drugs targeting the A3 adenosine receptor. On this page, readers can follow company announcements on clinical trial progress, regulatory designations, patent developments, financing events, and corporate actions related to its oncology, liver disease, inflammatory, and sexual dysfunction programs.
Recent news has highlighted pivotal and mid-stage clinical studies, including a Phase III trial of Namodenoson in advanced hepatocellular carcinoma, a Phase IIb trial in MASH, and a Phase IIa study in pancreatic cancer. The company has also reported compassionate use cases in advanced liver disease and cirrhosis, as well as long-term survival outcomes in liver cancer patients treated with Namodenoson. For Piclidenoson, updates include Phase III psoriasis development and protocol preparation for rare diseases such as Lowe Syndrome, along with preclinical findings in vascular dementia models.
News items also cover CF602, an A3AR allosteric modulator in development for erectile dysfunction, including patent allowances and grants in markets such as Brazil, the United States, and Europe. Can-Fite regularly reports on its intellectual property strategy, out-licensing and distribution agreements for human and veterinary indications, participation in industry conferences, and capital markets activities such as public offerings, warrant amendments, and share structure changes like reverse splits and ADS ratio adjustments.
Investors and observers can use this CANF news feed to monitor key milestones that may affect the company’s clinical pipeline, regulatory interactions, partnering discussions, and financial position over time.
Can-Fite BioPharma (NYSE: CANF) has announced projected future revenues of $685M from its partnerships, based on a comprehensive analysis of its current partnerships and market potential for lead drug candidates Piclidenoson and Namodenoson.
The revenue forecast spans the next decade and covers four key indications: psoriasis, advanced liver cancer, pancreatic cancer, and MASH. The projection assumes regulatory approvals and product launches between 2027 and 2029, varying by indication and territory.
The company's seven partnerships include various revenue streams such as:
- Development and regulatory milestones
- Commercial sales benchmarks
- Manufacturing-related transfer payments
- Royalties on product sales
Can-Fite BioPharma (NYSE: CANF) reported financial results for 2024 and provided clinical updates. A notable highlight includes an 8-year cancer-free survival in a liver cancer patient treated with Namodenoson under compassionate use. The company's drug candidates showed significant progress:
Key Developments:
- Namodenoson received FDA Orphan Drug Designation for pancreatic cancer
- Piclidenoson initiated Phase 3 psoriasis trials
- Partnership with Vetbiolix for canine osteoarthritis could generate $325 million over next decade
Financial Results:
- 2024 revenues: $0.67M (down 9.3% YoY)
- R&D expenses: $5.75M (down 3.8%)
- Net loss: $7.88M (vs $7.63M in 2023)
- Cash position: $7.88M as of December 31, 2024
Can-Fite BioPharma (NYSE: CANF) has initiated a pivotal Phase 3 study for its oral drug Piclidenoson in treating moderate to severe plaque psoriasis, following protocol approval from both FDA and EMA. The study will begin enrolling patients in Europe, with US and Canada expected to follow.
The randomized, double-blind, placebo-controlled trial will evaluate 3mg twice daily oral Piclidenoson tablets versus placebo. The co-primary efficacy objectives include achieving a PASI 75 score and a Static Physician's Global Assessment of 0 or 1 at Week 16.
The FDA has requested two Phase 3 safety and efficacy studies and encouraged including adolescent patients due to the drug's strong safety profile. The company aims to submit a New Drug Application to the FDA and Marketing Authorization Plan to the EMA upon positive study conclusion. The psoriasis market is projected to reach $30 Billion by 2030, with a significant shift toward oral medications.
Can-Fite BioPharma (NYSE: CANF) announced that its partner Vetbiolix is launching an advanced clinical study for Piclidenoson in dogs with osteoarthritis, following a successful two-month clinical trial. The companion animal arthritis market, valued at $3.8 billion in 2023, is projected to reach $6.3 billion by 2030.
Piclidenoson is expected to capture up to 6% market share, with potential peak worldwide sales of $445 million by 2034. Can-Fite will receive a 15% royalty on worldwide sales, projecting aggregate revenues of $325 million over the next decade with an anticipated 2029 launch.
The drug offers advantages over current treatments, including oral NSAIDs with harmful side effects and injectable DMOADs. Piclidenoson presents a potentially safer and more effective oral treatment option, supported by favorable safety profiles in both human and animal studies.
Can-Fite BioPharma (NYSE American: CANF) has announced the completion of Phase II study design for Piclidenoson in treating Lowe Syndrome, a rare genetic disease. The open study, led by Dr. Franchesca Emma from Bambino Gesù Children's Hospital, will enroll 5 patients treated with 3 mg Piclidenoson twice daily for 12 months.
The study aims to evaluate Piclidenoson's efficacy in increasing 99mTc-DMSA renal uptake. This initiative follows successful pre-clinical work by Dr. Antonella De Matteis at the University of Naples Federico II. Can-Fite has partnered with Fondazione Telethon for the clinical development.
Lowe Syndrome, occurring mainly in males, affects approximately 1 in 500,000 people and causes vision problems, kidney issues, and brain abnormalities. The condition currently has no available drug treatment, and patients rarely live beyond 40 years. Pre-clinical studies showed Piclidenoson significantly decreased urinary protein loss, making it the only effective compound found among thousands tested.
Can-Fite BioPharma (NYSE American: CANF) announced FDA approval for compassionate use of its anti-cancer drug Namodenoson in a U.S. pancreatic cancer patient. Compassionate use allows physician-requested access to unapproved investigational drugs for serious diseases.
Namodenoson is currently undergoing multiple clinical trials, including LiverationTM, a pivotal Phase III study for advanced liver cancer approved by both FDA and EMA, and a Phase IIa pancreatic cancer study in Israel. The drug has received Orphan Drug Designation from the FDA for pancreatic cancer, potentially providing seven years of market exclusivity post-approval along with regulatory advantages.
Can-Fite BioPharma (NYSE: CANF) announced the publication of an innovative study in the European Society of Medicine Journal highlighting the protective effects of Namodenoson in liver cancer treatment. The study, conducted in collaboration with hepatologists from Soroka University Medical Center, demonstrates the drug's anti-ischemic, anti-inflammatory, anti-fibrotic, and anti-toxicity properties across multiple body systems.
Unlike conventional chemotherapy, Namodenoson shows protective effects on the liver, central nervous system, and cardiovascular system by increasing adiponectin levels. The drug is currently in a pivotal Phase III study (LiverationTM) for advanced liver cancer, with both FDA and EMA approval. Notably, Namodenoson has received Orphan Drug status from both agencies and Fast Track status from the FDA.
Can-Fite BioPharma (NYSE American: CANF) reported significant clinical progress with its drug Namodenoson in treating decompensated liver cirrhosis under a compassionate use program. After 20 months of treatment, the patient showed notable improvements, including resolution of moderate ascites, no further gastrointestinal bleeding episodes, and decreased liver stiffness and globulin levels.
Dr. Ohad Etzion from Soroka Medical Center highlighted the drug's potential importance, given the treatment options currently available besides liver transplantation. The liver cirrhosis treatment market is projected to reach approximately $15 billion in the U.S. by 2030, addressing a global patient population of 10.6 million affected by decompensated cirrhosis as of 2017.
Can-Fite BioPharma (NYSE American: CANF) has announced an upcoming investor webinar scheduled for February 25, 2025, at 4:15 p.m. ET. The event will feature presentations from CEO Motti Farbstein and Executive Chairperson/CSO Dr. Pnina Fishman, focusing on the company's development pipeline and upcoming milestones.
The company has secured multiple out-licensing deals with potential regulatory and sales milestone payments exceeding $130 million, of which $20 million has already been received in upfront and milestone payments. Can-Fite's advanced-stage assets target markets valued at over $70 billion, positioning the company for potential commercialization of its therapies targeting oncological and inflammatory diseases.
Can-Fite BioPharma (NYSE American: CANF) has announced its participation in the BIO CEO & Investor Conference 2025, scheduled for February 10-11, 2025, in New York City. The company's Chief Executive & Chief Financial Officer, Motti Farbstein, will present on February 10 at 3:45 pm EST at the New York Marriott Marquis.
During the conference, management will conduct one-on-one meetings with investors and potential partners to discuss business strategy, clinical milestones, and development plans. The company's drug pipeline includes Namodenoson, currently in a pivotal Phase III trial for advanced liver cancer and a Phase IIb study for Metabolic Dysfunction-associated Steatohepatitis (MASH). Additionally, Piclidenoson is preparing to enter a pivotal Phase III trial for psoriasis.