Can-Fite BioPharma Ltd. Stock Price, News & Analysis

Can-Fite BioPharma (NYSE American: CANF) reports growing interest from leading U.S. medical centers seeking FDA compassionate use approval for Namodenoson in pancreatic carcinoma treatment. This follows the FDA's recent approval of the first single-patient compassionate use treatment with the oncological drug.

The company is currently enrolling patients in Israel for a Phase IIa study, an open-label trial for advanced pancreatic adenocarcinoma patients whose disease has progressed despite first-line therapy. The study, led by Dr. Salomon Stemmer at Rabin Medical Center, aims to evaluate safety, clinical activity, and pharmacokinetics of Namodenoson.

Notably, Namodenoson has received Orphan Drug Designation from the U.S. FDA, highlighting its potential as a treatment option for this underserved patient population.

Can-Fite BioPharma (NYSE American: CANF) has announced a $3.0 million registered direct offering of American Depositary Shares (ADSs). The company will sell 2,500,000 ADSs at $1.20 per share, with the offering expected to close around April 15, 2025.

H.C. Wainwright & Co. is serving as the exclusive placement agent for this offering, which is being conducted under a previously filed shelf registration statement. The net proceeds will be allocated to:

• Research and development funding
• Clinical trials
• Working capital
• General corporate purposes

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.