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

Can-Fite BioPharma (NYSE American: CANF) has announced a public offering to raise up to $15.0 million in gross proceeds. The offering includes 8,333,333 American Depositary Shares (ADSs) at $0.60 per ADS, along with short-term warrants to purchase up to 16,666,666 ADSs.

The initial gross proceeds are expected to be $5.0 million, with potential additional proceeds of $10.0 million if all warrants are exercised. The warrants have an exercise price of $0.60 per ADS and will expire in 24 months. The offering is expected to close around July 29, 2025, with H.C. Wainwright & Co. acting as the exclusive placement agent.

Can-Fite BioPharma (NYSE American: CANF) announced breakthrough results from a UCLA study demonstrating the efficacy of Piclidenoson in treating vascular dementia. The study, led by Dr. S. Thomas Carmichael at UCLA's Geffen School of Medicine, showed that Piclidenoson successfully restored tissue integrity and behavioral function in a vascular dementia mouse model.

Vascular dementia, the second most common form of dementia after Alzheimer's, currently has no FDA-approved treatments. The global market for vascular dementia treatments is valued at $6 billion as of 2025, with a projected 5% CAGR through 2035. Piclidenoson, a selective A3 adenosine receptor agonist, has already demonstrated a strong safety profile in hundreds of psoriasis patients through Phase 2 and Phase 3 clinical studies.

Can-Fite BioPharma announced that Dr. Sari Fishman will present updates on their ongoing Phase IIa pancreatic cancer study at the 2025 BIO International Convention in Boston. The open-label study is evaluating Namodenoson, which has received FDA Orphan Drug Designation, in patients with advanced pancreatic adenocarcinoma who have progressed after prior therapy. The trial, led by Prof. Salomon Stemmer at the Davidoff Center, aims to assess safety, clinical activity, and pharmacokinetics of Namodenoson administered at 25 mg twice daily in 28-day cycles. Currently, 50% of the planned 20 evaluable patients have been enrolled, with the drug showing a favorable safety profile so far. The study represents an effort to address the unmet need for effective treatments in advanced pancreatic cancer patients who have exhausted standard therapies.

Can-Fite BioPharma (NYSE: CANF) has announced a total funding milestone of $175 million to advance its key drug candidates into Phase III trials. The company's lead candidates include Namodenoson for liver cancer and Piclidenoson for psoriasis, both targeting the A3 adenosine receptor (A3AR). Namodenoson is currently in a pivotal Phase III study for advanced liver cancer and Phase IIa for pancreatic cancer, while also being tested in Phase IIb for MASH. Piclidenoson is advancing in a pivotal Phase III trial for moderate-to-severe psoriasis. Both drugs have demonstrated promising safety profiles and efficacy in Phase II trials. Can-Fite has secured seven commercialization agreements with strategic partners and continues to seek additional partnerships for future drug marketing upon regulatory approval.

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.