A clinical trial recently produced data that an experimental drug called Namodenoson, developed in Israel, induces weight loss in experimental models and normalizes glucose levels. The study is being conducted by Dr. Rifaat Safad at the Hadassah Medical Center in Israel. The study’s sponsor, Can-Fite BioPharma Ltd (CANF), could be onto something big as the obesity epidemic rages. This emerging biotech is a scrappy fighter with a brilliant, energetic, and tenacious academic CEO that just may prevail. Can-Fite is appropriately named—they will fight until they are successful.
The Israeli startup sponsor recently reported on new pre-clinical studies of the experimental drug that reveal a significant reduction in weight in both high-fat diet mouse models and in diabetic-rate models. Additionally, the latest lab shows the drug normalized glucose levels in a glucose tolerance test (GTT). Based on these findings, the sponsor has filed a patent with the World Intellectual Property Organization (WIPO) for the utilization of Namodenoson as an anti-obesity drug.
The Preclinical Investigator & Site
The preclinical research has been conducted at the labs of Dr. Rifaat Safadi at the Hadassah Medical Center. Dr. Safadi heads the Liver Unit, Gastroenterology and Liver Diseases, Division of Medicine at the Hadassah Medical Center, and is the professor of Internal Medicine, Bowell, Liver Disease and Metabolic Syndrome at Hebrew University in Israel, and Principal Investigator of Can-Fite’s Phase II study of Namodenoson in the treatment of patients with NAFLD and NASH. Dr. Safadi commented, “This new weight loss data, together with the good safety profile of Namodenoson, supports its potential utilization as an anti-obesity drug.”
Global Obesity Market Big
TrialSite News has warned readers that we are facing a worldwide and unprecedented health epidemic with particularly severe implications in countries such as America, where obesity rates are alarmingly high. Some market research calls the obesity market to hit $12 billon by 2023. TrialSite News highlighted Novo Nordisk as the leading big pharma making active investments.
The Experimental Drug: Namodenoson
Can-Fite’s experimental drug Namodenoson is being tested in Phase II in patients with NAFLD with or without NASH, with evidence of active inflammation. The primary endpoint of the study is serum ALT levels and a secondary endpoint of percentage change in liver fat—as measured by proton density fat fraction—PDFF. The company hopes to release data for the Phase II NAFLD/NASH study during Q1 2020.
The drug is a small orally bioavailable drug that binds with high affinity and selectively to the A3 adenosine receptor (A3AR). It is also being evaluated as a second-line treatment for hepatocellular carcinoma, recently completed in Phase II trial and entering a Phase III trial for this indication. 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, reports its sponsor.
The Sponsor: Can-Fite BioPharma Ltd: A Relentless Small Dealmaker
Based in Israel and traded on the NYSE American (CANF) and Tel Aviv (CFBI), the company positions itself as 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, inflammatory disease, and sexual dysfunction. Its lead drug candidate, Piclidenoson, is presently in Phase III trials for rheumatoid arthritis and psoriasis. The sponsor’s liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma (HCC), the most common form of liver cancer and is in a Phase II trial for NASH. 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 US FDA.
The company reports that Namodenson shows proof of concept potential to treat other cancers such as colon, prostate, and melanoma. The company’s third drug candidate, CF602, has shown efficacy in the treatment of erectile dysfunction in preclinical studies, and the company probes other potential uses targeting A3AR for the treatment of sexual dysfunction. These drugs thus far have evidence a good safety profile, and the sponsor claims experience with over 1,000 patents in clinical trials thus far.
Financials & Business
With a share price of $3.52, there is little market capitalization at $14.8 million. They project a loss of $11.2 million and about $4.7 million cash in the bank, according to Yahoo Finance. They report a loss of $7.84 million for the nine months, ending September 30, 2019, according to public reports. Like many emerging biopharma, they went public (November 2013) to raise funds and have seen their share price steadily decline to the point where they are in the microcap land. They were recently able to raise $10.1 million, which was offset by cash used in operating activity worth $9.1 million, according to their latest investor quarterly report. But this group does multiple deals annually, while also entertaining nasty lawsuits. They are difficult for an analyst to keep up with.
The most recent financing occurred by May 2019, the company had sold 1.5 million shares in a registered direct, offering at $4.00 per share leading to $6 million. They also issued to these investors unregistered warrants to purchase an aggregate of 1.5 million share in a private placement.
The company has 5 institutional investors and shareholders on record (e.g. filing 13D/G or 13F forms with the SEC), including Morgan Stanley, Susquehanna International Group, Citadel Advisors LLC, Advisornet Financial, Inc., and Bank of Montreal.
With financings in each successive year over the last handful of years, Can-Fite represents a volatile emerging business but with a brilliant CEO that is tough as nails. They obtain what appears to be a solid underlying potential science, with which this group could produce a windfall.
Financing and Legal Mess with Capital Point Ltd.
As of May 2019, they reported that Capital Point Ltd. acquired over 5% of the company. Apparently, by June, Capital Point was demanding a board seat and other board and management changes that the company resisted. Apparently Capital Point Ltd. and Can-Fite didn’t have a true understanding of intentions prior to the investment, and the two are engaged in an ugly, nasty legal squabble in Tel Aviv District Court with an appeal to the Supreme Court. A Seeking Alpha writer has covered this mess and suggests the two sides make peace. And by October 7, 2019 the two did enter into an agreement where the two sides agreed to be civil and work together—we will see how that goes.
Licensing: Deals Galore
According to their prospectus, their allosteric modulator of the A3AR, CF602 product originates from Leiden University in Holland. Additionally, they have undertaken the following out-license deals: 1) Piclidenoson for the treatment of (A) rheumatoid arthritis to Kwang Dong Pharmaceutical Co. Ltd for Korea (B) psoriasis and RA to Cipher Pharmaceuticals, Canada; (C) RA and psoriasis to Gebro Holding, Spain, Switzerland and Austria and (D) RA and psoriasis to CMS Medical, China (includes Mainland and Hong Kong, Macao and Taiwan); and 2) Namodenoson for the treatment of (A) liver cancer and NASH to Chong Kun Dang Pharmaceuticals for South Korea (B) advanced liver cancer and NAFLD/NASH to CMS Medical, China (includes Mainland and Hong Kong, Macao and Taiwan).
Even doing Cannabis Deals!
This entrepreneurial whirlwind just didn’t stop—while entangled with legal squabbles with new investors, they in parallel were cutting deals to get into the cannabis market via a deal with Univo, a medical cannabis company. The two sought to identify and co-develop specific formulations of cannabis components for the treatment of cancer, inflammatory, autoimmune and metabolic diseases. They paid Univo a total of $500,000 through two installment payments and issued them 19.9 million ordinary shares via a private placement representing 16.6% of the company. The companies will jointly share the intellectual property of any co-produced products—Univo will provide Can-Fite with cannabis and cannabis components as well as full access to its laboratories for research and manufacturing.
Clearly, the principals behind Can-Fite are fighters and entrepreneurial to the bone—in some ways, we have to admire their passion, commitment, and business spirit in forging ahead and doing whatever is necessary to win and be successful. But we probably wouldn’t have the stomach to face the scenarios and situations they do—risk factors are comparable to many emerging biopharma, but for Can-Fite perhaps things are a little intensified just because of the circumstances discussed. These risks come down to: 1) uncertainties of cash flows and inability to meet working capital needs, 2) initiation, timing, progress and results of preclinical studies, clinical trials and other product candidate development efforts, 3) ability or lack thereof of progressing product candidates into clinical trials or to successfully progress research from preclinical to clinical, 4) ability to secure positive regulatory approvals in a timely manner, 5) commercialization, and 6) the ability to maintain solid industry partnerships and collaborations and so on.
Dr. Rifaat Safadi at the Hadassah Medical Center
Call to Action: Clearly CEO Pnina Fishman, PhD, CEO is not only brilliant but one tough cookie who will, let’s say, forget “Can fight—she Will fight.” An academic, she is the scientific founder of what is clearly a promising platform and surely knows something about research, being previously headed the Laboratory of Clinical and Tumor Immunology, Felsenstein Medical Research at Rabin Medical Center. Professor Fishman has authored over 150 publications. She has been involved with numerous research and start-up endeavors. TrialSite News actually believe this little dynamo of a firm is quite undervalued but, of course, the risks are still high. If it can bring stability to its financings, it surely knows science, business and deal making and, importantly, thrusts forward with tenacity and no fear. Consistent execution will be the key moving forward.