PETACH TIKVA, Israel - Can-Fite BioPharma (NYSE:CANF) Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology firm, has announced new findings from its research on Namodenoson, a drug candidate for cancer and liver protection. Scientists at Can-Fite discovered that Namodenoson's anti-cancer and liver protective effects are mediated through the signaling protein adiponectin, known for its role in anti-inflammatory and metabolic processes.
The company is set to present this data at the 20th Annual Congress of International Drug Discovery (NASDAQ:WBD) Science & Technology, China Branch, scheduled for September 12-14 in Shanghai, China. Namodenoson has shown promise in increasing adiponectin production in both pre-clinical studies and human trials.
Dr. Pnina Fishman, Can-Fite's CSO & Chairperson, expressed excitement about the breakthrough findings, which elucidate Namodenoson's dual mechanism as an anti-cancer agent and liver protector. Namodenoson is currently undergoing a pivotal Phase III study for advanced liver cancer, known as LiverationTM, which has received approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Additionally, the drug is being evaluated in a Phase IIb study for patients with non-alcoholic steatohepatitis (NASH).
Namodenoson targets the A3 adenosine receptor (A3AR), which exhibits high expression in diseased cells but low expression in normal cells. This selectivity is believed to contribute to the drug's favorable safety profile. The drug has been tested in Phase II trials for hepatocellular carcinoma and as a treatment for non-alcoholic fatty liver disease (NAFLD) and NASH.
Can-Fite has a broader portfolio, including Piclidenoson, which is nearing a pivotal Phase III trial for psoriasis, and CF602, which has shown efficacy in treating erectile dysfunction. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe, as well as Fast Track Designation by the FDA as a second line treatment for hepatocellular carcinoma. The drug also has potential applications in treating other cancers, such as colon, prostate, and melanoma.
In other recent news, Can-Fite BioPharma Ltd. has been making significant strides in drug development and clinical trials. The company's drug candidate, Namodenoson, received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for the treatment of advanced liver cancer. It is now undergoing a Phase 3 pivotal study named LIVERATION, recruiting participants across 31 medical centers in Europe, Israel, and the United States.
Additionally, the FDA has granted Investigational New Drug (IND) clearance for Namodenoson, enabling the company to include U.S. patients in its ongoing Phase IIb clinical trial for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Can-Fite's CEO Motti Farbstein expressed optimism about the IND clearance, stating it would contribute to the diversity of the study's population.
Can-Fite BioPharma Ltd. also received a Notice of Allowance from the European Patent Office for its erectile dysfunction (ED) treatment patent, about the CF602 drug candidate. The company has expanded its agreement with Ewopharma to include marketing rights for Namodenoson in treating pancreatic carcinoma.
InvestingPro Insights
As Can-Fite BioPharma Ltd. (NYSE American: CANF) continues to make strides in the development of Namodenoson, investors may be evaluating the company's financial health and stock performance. According to InvestingPro data, CANF has a Price/Book ratio of 2.18 as of the last twelve months ending Q4 2023, suggesting that the stock is potentially trading at over twice the value of the company's net assets. This could be a reflection of investor confidence in the future prospects of Namodenoson and the company's drug pipeline.
Despite the scientific advancements, CANF's revenue has shown a decrease, with a -8.27% change over the last twelve months as of Q4 2023. Moreover, the company's operating income margin was notably negative at -1102.96% for the same period, indicating significant expenses relative to revenue. These financial metrics underscore the challenges faced by biotech companies like Can-Fite in managing costs while investing heavily in research and development.
From an investment standpoint, CANF has experienced a strong return over the last three months, with a 22.2% price total return. This performance, alongside the fact that the company holds more cash than debt on its balance sheet, as highlighted by one of the InvestingPro Tips, may attract investors looking for growth opportunities within the biotech sector. However, it is also important to note that analysts do not anticipate the company will be profitable this year, and the stock has taken a significant hit over the last week with a -15.11% price total return.
For those interested in a deeper analysis, InvestingPro offers additional tips on CANF, which can be found by visiting their dedicated page at https://www.investing.com/pro/CANF. Potential subscribers can also use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking further insights into Can-Fite's financial metrics and stock performance.
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