Can Fite BioPharma Ltd (CANF)

[midastouch017]

CANF - Waiting For FDA Approval Of IND For Phase 2 Covid-19 Trials Using Oral Anti-Viral & Anti-Inflammatory Drug Piclidenoson

Aug. 11, 2020 3:13 PM ET|About: Can-Fite BioPharma Ltd. (CANF), Includes: ALT, ARDS, CAPR, FAST, IMRN, INO, NVAX, SRNE, VXRT
Summary

On July 27, 2020, Can-Fite submitted an IND application to the FDA for a Phase II study of its lead drug candidate Piclidenoson for moderate to severe COVID-19 patients.

The IND application is based on feedback and guidance from the FDA from prior pre-IND advice.

During the July 23, 2020 investors' call, CFO Farbstein ruled out further dilution near-term since they have ample resources from the recent stock offerings. Can-Fite is funded to 1Q 2022.

Piclidenoson, being oral, has significant advantages over competitors using IV-delivered drugs because pills are not dependent on temperature and can be shipped and deployed all over the world quickly where needed.

I believe CANF has the potential to become the next Sorrento Therapeutics (SRNE). However, because of Can-Fite's huge pipeline and the potential for partnerships with big pharma, long-term Can-Fite could be a more consistent gainer.

Discussion
July 27, 2020 - Can-Fite Submits IND Application to the FDA for COVID-19 Phase II Study
28-day study in hospitalized patients with moderate COVID-19 symptoms
Piclidenoson is an anti-inflammatory drug with a well-established safety profile
On July 27, 2020, the company announced that it has submitted an Investigational New Drug (IND) application to U.S. Food and Drug Administration (FDA) for a Phase II study of its lead drug candidate Piclidenoson in the treatment of COVID-19.

The IND application is based on feedback and guidance from the FDA from prior pre-IND advice.

Piclidenoson has been dosed in over 1,000 patients and proven safe in prior trials as well as two ongoing Phase III studies for the treatment of rheumatoid arthritis and psoriasis.

Can-Fite CEO Dr. Pnina Fishman commented:

“With the unfortunate resurgence of COVID-19 infections worldwide, the urgency of finding effective treatments for COVID-19 is more pressing now than ever. Working with the FDA through its Coronavirus Treatment Acceleration Program (CTAP), we expect IND activation soon to begin our Phase II trial."

The press release further stated:

"The Phase II study titled, “Piclidenoson for Treatment of COVID-19 – A Randomized, Double Blind, Placebo-Controlled Trial” is a pilot trial in a population of hospitalized patients who will receive Piclidenoson in addition to standard supportive care. Eligible patients are those with “moderate” COVID-19 per U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Forty patients will be randomly assigned in a 1:1 ratio to the trial arms of Piclidenoson 2 mg twice daily or placebo, and treated for up to 28 days. Efficacy will be assessed through standard measures of clinical and respiratory status at Day 29, including the proportion of patients alive and free of respiratory failure, as well as the proportion discharged home without need for supplemental oxygen. Safety and pharmacokinetic data will also be captured."

Importantly, Can-Fite's Phase 2 COVID-19 drug candidate Piclidenoson, being oral, has significant advantages over competitors using IV-delivered drugs because pills are not dependent on temperature and can be shipped and deployed all over the world quickly where needed providing an enormous logistical advantage in large, global therapy campaigns.
The following are highlights regarding Piclidenoson's features as a potentially effective COVID-19 therapy since it has anti-viral and anti-inflammatory effects (Source: August 6, 2020 Corporate Presentation):



COVID-19 Might Stay Around us Longer Than Expected - Horrible Long-Term Effects
As we learn more about COVID-19, experts are telling us to brace ourselves for a long co-existence with this horrible virus. Vaccines may or may not work, may not be for everyone, and their potential effectiveness is in question as the virus keeps mutating in unpredictable ways. I believe finding effective COVID-19 therapies (CANF could produce one of them) will help humankind more than anything in addition to accurate test for the virus and for antibodies. Even if people develop antibodies, scientists are learning that those fade away in a few weeks and they are not sure if those people could get reinfected by the virus...and to what extent.

One article's headline is scary "Experts no longer expect seasonal coronavirus waves: The pandemic is like 'a forest fire looking for human wood to burn'..."

Experts no longer expect seasonal coronavirus waves: The pandemic is like 'a forest fire looking for human wood to burn'

This other one is even more worrisome: "Effects of coronavirus pandemic will be felt for decades: World Health Organization."

Effects of coronavirus pandemic will be felt for decades: World Health Organization

Unfortunately for humanity we might have to adapt our lifestyles and way of living to survive it. Millions might not be able to see their loved ones living in other countries...tourism might eventually die...our jobs will never be the same...the key words going forward are "survival and adaptation." And it's also important to realize that even if a person has mild symptoms, the long-term effects of the virus might be crippling by causing chronic damage to organs, the nervous system, the cardiovascular system,

More on Can-Fite Including Its COVID-19 Therapy Program
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is 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 COVID-19.

Can-Fite's platform technology is based on a specific target, the A3 adenosine receptor (A3AR), present in high concentrations in inflammatory and cancer cells but not in normal body cells. The company's proprietary drugs target and bind with A3AR and cause cancer and inflammatory cells to die. This creates a targeted anti-cancer and anti-inflammatory effect, while leaving normal cells unharmed. The A3AR receptor is also a biological predictive marker which helps to identify individual patients' responsiveness to our drugs.

The Company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Piclidenoson has been approved for a pilot clinical trial in Israel to treat COVID-19 infected patients with moderate-to-severe symptoms.

Can-Fite's liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and successfully achieved its primary endpoint in a Phase II trial for the treatment of non-alcoholic steatohepatitis (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 U.S. Food and Drug Administration.

The U.S. Patent and Trademark Office issued a Notice of Allowance to Can-Fite for Namodenoson in the treatment of NASH & NAFLD. A patent was issued for Namodenoson in the treatment of NASH in South Korea, where the drug is out licensed for this indication. Can-Fite has also filed a new patent for Namodenoson to be used as a combination therapy with checkpoint inhibitors for oncology indications.

Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction.

Additionally, based on its recent scientific findings in cannabinoid-based drugs, Can-Fite has filed patents for the use of such drugs to treat cancer, autoimmune, inflammatory and metabolic diseases.

Both, Piclidenoson and Namodenonson, have an excellent safety profile with experience in over 1,000 patients in clinical studies to date.

The following slide from the August 6, 2020 Corporate Presentation summarizes Can-Fite's unique technology platform:



July 15, 2020 Phase 2 COVID-19 Protocol Completion

Can-Fite Biopharma Ltd. announced on July 15, 2020 that, with FDA guidance and review, it had completed a Phase II protocol for a study titled, “Piclidenoson for Treatment of COVID-19 – A Randomized, Double Blind, Placebo-Controlled Trial.”

The press release stated:

"This will be a randomized, double blind, placebo-controlled trial in a population of hospitalized patients who all receive standard supportive care. Eligible patients are those diagnosed with “moderate” COVID-19 per U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Forty patients will be randomly assigned in a 1:1 ratio to the trial arms of Piclidenoson 2 mg twice daily or placebo and treated for up to 28 days. Efficacy will be assessed through standard measures of clinical and respiratory status at Day 29, including the proportion of patients alive and free of respiratory failure, as well as the proportion discharged home without need for supplemental oxygen. Safety and pharmacokinetic data will also be captured."

Can-Fite CEO Dr. Pnina Fishman commented:

“We believe Piclidenoson is a promising candidate to treat COVID-19 because it combines both anti-viral and anti-rheumatic properties in one drug. Recent studies have shown anti-viral and anti-rheumatic drugs have improved outcomes for COVID-19 patients, leading to the U.S. FDA issuing emergency use authorization for the anti-viral drug remdesivir for the treatment of COVID-19, while some U.S. hospitals are treating COVID-19 patients with Actemra® (tocilizumab), a rheumatoid arthritis drug.”

The following are other highlights from the July 23, 2020 investors' call prior to IND submission:

CFO Motti Farbstein stated that they don't expect further dilution in the near-term since they have ample resources from the recent stock offerings and warrants. The expected runway is 12 to 18 months.
CEO Fishman commented that they are seeking non-dilutive cash infusion from US and Israel government agencies to help accelerate the Phase 2 COVID-19 therapy program
Can-Fite's CEO believes that the current market cap is significantly undervalued (currently less than $40M) considering that late-stage pipeline addresses large markets (NASH, liver cancer, rheumatoid arthritis, psoriasis, erectile disfunction, etc.).
CEO Fishman was asked by a caller if there were any offers from other biotech/pharma companies to buy them or to form partnerships with them since their pipeline of drugs looks very promising. She simply answered: "I think you know now the answer to that question." To me that implies that yes, there have been or there might be ongoing conversations regarding partnerships, buyout, etc. Obviously, this is all speculation from my part, but as you learn more about this unique, relatively unknown company, you can make your own judgement
Why Piclidenoson For Phase 2 COVID-19 Clinical Trials?
The July 15, 2020 announcement came on the heels of the June 9, 2020 news that the FDA has provided detailed comments regarding the prospective use of Piclidenoson to treat patients suffering from COVID-19.

Piclidenoson has a well-established safety profile in clinical studies in the U.S. and abroad and has been dosed in over 1,000 patients for the treatment of rheumatoid arthritis and psoriasis. The use of A3AR agonists as potent anti-inflammatory agents in addition to standard of care in acute infectious diseases where host defense responses are overwhelming, leading to cytokine storm and death, is supported by several peer reviewed studies, as well as by Can-Fite’s own work in the field of adenosine biology. A3AR agonists have been shown to be effective in models of inflammatory cytokine production and sepsis resulting in apoptosis of inflammatory cells.
The activity of Piclidenoson as an anti-inflammatory agent has been tested in several different experimental models including adjuvant and collagen-induced arthritis and inflammatory bowel disease. In all models tested, Piclidenoson induced a robust anti-inflammatory effect measured by clinical and histological disease scores.

Can-Fite has licensed Piclidenoson for the treatment of autoimmune diseases to Cipher Pharmaceuticals in Canada, to Gebro Pharma GmbH in Spain, Switzerland & Austria, for RA to Kwang Dong in Korea and to CMS for RA and Psoriasis in China, Taiwan, Hong Kong, Macao.

As stated previously, Piclidenoson, being oral, has significant advantages over competitors using IV-delivered drugs because pills are not dependent on temperature and can be shipped and deployed all over the world quickly where needed providing an enormous logistical advantage in large, global therapy campaigns.

Can-Fite CEO, Dr. Pnina Fishman commented,

“We are grateful for the thoughtful and comprehensive guidance from the FDA. Using the FDA’s feedback on our clinical trial, we anticipate submitting an IND shortly. We believe that Piclidenoson’s anti-viral, anti-inflammatory, anti-rheumatic properties and excellent safety profile make it a strong candidate for the potential treatment of COVID-19.”

The planned Phase II trial will evaluate the efficacy and safety of Piclidenoson, when added to the current standard of care treatment, for COVID-19 infected patients with moderate-to-severe symptoms.

During the 1Q 2020 conference call CEO Fishman commented:

"We had previously announced that we were approved to commence a COVID-19 clinical study in Israel. While we did commence this trial, we have not enrolled patients due to the decreasing number of COVID-19 patients in Israel. We’re now focusing our COVID-19 clinical development in U.S. which currently has the largest number of cases in the world. During the first quarter, we also entered collaborative research agreement with the Lewis Katz School of Medicine at Temple University, Philadelphia to study the anti-viral activity of Piclidenoson on COVID-19 viral load."

The timing for these clinical trials could not be better because as we all know many states have recently reported record levels of COVID-19 contamination. In fact, several states, cities and counties are rolling back their intentions to open their economies as the level of contamination/hospitalizations has forced them to activate "red alert" measures. Globally, the situation is even worse as Mexico, Brazil, Peru, Chile, India, are nearing or exceeding contamination and hospitalization levels seen at the peak of the pandemic.

It is widely known that some critically ill COVID-19 victims experience Cytokine Release Syndrome or CRS as an adverse event that may result in multiple organ failure or acute respiratory distress syndrome (ARDS). CRS is defined as an inflammatory condition occurring when many lymphocytes and/or myeloid cells are being activated, releasing high levels of inflammatory cytokines. CRS can occur within minutes or hours, but it can also take place days or weeks later.

Several recent publications suggest that in the later stages of COVID-19 related complications overstimulation of the immune system is likely responsible for triggering CRS causing the body to become overwhelmed with pro-inflammatory molecules. CRS is initially manifested by high fever, nausea, headache, tachycardia, hypotension, cardiac dysfunction, rash, and shortness of breath. However, this immune response may become excessive thus inducing accelerated and hard to control pneumonia, multiple organ failure, ARDS, and ultimately death. Ironically, it appears that the body's uncontrolled overreaction to COVID-19 is what delivers the fatal blow rather than the virus itself.

Can-Fite CEO Fishman has deep personal knowledge in the area of cytokine storm, sepsis, and Cytokine Release Syndrome. On January 30, 2019 she co-authored the article entitled: "Targeting the A3 adenosine receptor to treat cytokine release syndrome in cancer immunotherapy."

In this article CEO Fishman states:

"The main cytokines involved with CRS include tumor necrosis factor-a (TNF-a), interferon ? (IFN-?), interleukin 1ß (IL-1ß), interleukin 2 (IL-2), interleukin 6 (IL-6), interleukin 8 (IL-8), and interleukin 10 (IL-10), all known to be involved in the regulation of the innate and cellular immunity. Following immunotherapy, the inflammatory cytokines are released, enhancing the immune response and activating the proliferation of immune cells to further secrete more inflammatory cytokines. This chain of events leads to a loop between the inflammatory cytokines and the immune cells, which may result in a cytokine storm."

"Adenosine, a ubiquitous purine nucleoside, induces a plethora of effects in the body via its binding to four adenosine receptors A1, A2a, A2b, and the A3. Highly selective agonists to the A3 adenosine receptor act as inhibitors of proinflammatory cytokines, possess robust anti-inflammatory and anticancer activity, and concomitantly, induce neuroprotective effects. Piclidenoson and Namodenoson belong to this group of compounds and are effective upon oral administration, show an excellent safety profile in human clinical studies, and therefore, may be considered as drug candidates to treat CRS."

"Overall, it looks like the current treatments for CRS are not satisfactory, and there is a need for a drug that will concomitantly act as a robust anti-inflammatory that will also prevent neurotoxic manifestations (referring to Piclidenoson which is the drug chosen for the company's COVID-19 therapy program)."

Potential Share Price Appreciation Upon Successful COVID-19 Phase 2a Clinical Trial Results
Positive Phase 2 results could increase the share price several-fold. As an example, Capricor made that kind of jump (500%+) after reporting positive trial results about its COVID-19 program ,using cardiac stem cells, on April 29, 2020.

".... five male patients and one female patient (between ages 19 and 75) suffering from COVID-19 received IV infusions of 150 million allogeneic cardio sphere-derived cells (CAP-1002). Of the five patients on ventilator support, four patients no longer required ventilator support within just one to four days following the infusion. The fifth patient remains on mechanical ventilation and the sixth patient is receiving supplemental oxygen and is currently clinically stable."

So, what are the similarity between CANF and CAPR? It's essentially the mode of action of Capricor's CAP-1002 and Piclidenoson. They both use the drug's immunomodulatory properties use to modulate inflammatory cytokines and to regulation of the immune response to prevent cytokine storm and sepsis.

The significant difference is the availability of the drug for massive global consumption.

Capricor's CAP-1002 is an IV-infused allogeneic cardiac cell-based therapy, and by its own nature its availability for large-scale application might be limited. The availability of allogenic cardiac cells for large-scale use is also questionable.
Piclidenoson, on the other hand is an orally bioavailable drug that can be produced/manufactured by the millions and easier transportable globally where needed.
Even companies like Immuron (IMRN) gained over 300% when it announced that its MM-124E, which is used in its commercially available Travelan product, has demonstrated neutralizing activity against COVID-19....during in-vitro research. Read this again, a 300% for positive in-vitro results?

I believe CANF has the potential to become the next Sorrento Therapeutics (SRNE). However, because of Can-Fite's huge pipeline and the potential for partnerships with big pharma, long-term Can-Fite could be a more consistent gainer

A Few Words About Can-Fite's NASH Clinical Trials
Most investors who follow biotechs should know that NASH is a huge market ($35B addressable market) with great unmet need.

Several competitors in the race to find a NASH therapy have suffered a series of setbacks while tiny Can-Fite keeps making steady and stellar progress. For instance, an announcement in late June by Intercept Pharmaceuticals that the Food and Drug Administration had said that the benefit of its proposed NASH treatment didn’t outweigh the potential risks.

Just this week, the French biotech Genfit, which had been expected to bring one of the first NASH drugs to the market, said it is getting out of the race altogether. In a statement this week, Genfit said it was ending a Phase 3 clinical trial of its drug elafibranor in NASH patients. In May, the company had said that an interim analysis had found that the study had failed to meet its primary endpoint.

The article "The Race to Find a Treatment For NASH; What is The Big Holdup?" states:

"Nonalcoholic fatty liver disease (NAFLD) is estimated to affect over 1 billion people worldwide and a significant proportion of these people are progressing to nonalcoholic steatohepatitis (NASH). In the next 2 years, NASH is set to overtake hepatitis C as the leading indication for liver transplantation yet worldwide, there is no licensed treatment."

"It’s been 38 years since NASH was first described yet advances in pharmacological therapy have been slow. The world has made fantastic advances in so many different liver treatments while NASH has taken a back seat. So why has it been such a tortuous road?"

"It has long been known that NAFLD implies steatosis, and steatosis has historically been thought of as a benign condition therefore many doctors did not see NASH as a concern. Once thought to be only a manifestation of obesity and/or diabetes, its clinical significance was questionable. Overall this lack of attention meant NASH was not a disease worth diagnosing or treating. As time went on, large observational studies on diabetic patients and mortality showed a significant amount of them were dying of cirrhosis, finally pushing NASH into the limelight."

"NASH gained attention in the medical world but that didn’t simply pave the way to new treatments. As a predominantly asymptomatic condition, many patients are diagnosed late due to normal examination and blood tests. The gold standard for diagnosis is an invasive and expensive liver biopsy which further complicates its diagnosis. Newly developed elastography scanning and other non-invasive tests/scoring systems have helped greatly with earlier recognition but the question is what do we do with those recognized as having NAFLD or NASH?"

"The ideal pharmacological NASH treatment would reduce hepatic inflammation, stop hepatocyte injury, correct insulin resistance and act as an antifibrotic. While there is nothing in development that will do all of these, several companies are trialing medications that will achieve just some of the above goals."

Now, keep those last comments in mind and compare them to the most recent NASH Phase 2 results that were reported by Can-Fite on June 30, 2020:

Study Highlights:

Anti-Inflammatory Effect
Namodenoson significantly reduced two liver enzymes, aspartate aminotransferase (AST) and alanine aminotransferase (ALT), which are elevated in a damaged liver, and increased the anti-inflammatory cytokine adiponectin known also to act as an anti-fibrotic factor.

Reduction of Liver Fibrosis
Patients treated with 25 mg of Namodenoson had a statistically significant reduction in hepatic fibrosis as measured by the Fibrosis-4 (FIB-4) score, as compared to placebo. FIB-4 change from baseline improved by -0.089 in patients dosed with 25 mg of Namodenoson, as compared to the placebo group which deteriorated from baseline by 0.042 points, with p=0.026. FIB-4 is a non-invasive marker of hepatic fibrosis consisting of four parameters including age, platelet counts, and AST and ALT.

Reduction of Liver Steatosis
In the Namodenoson 25 mg treated group, the proportion of patients with high steatosis scores declined from 37.5% to 13.3% of the population, as compared to the placebo treated group in which the proportion of patients with high steatosis scores decreased from 37.5% to 35.3% of the population, with p=0.08. Steatosis was assessed by Controlled Attenuation Parameter (CAP) measurement of the FibroScan, a non-invasive marker of hepatic steatosis.

NASH – All Cases Resolved
25% of patients randomized into the Namodenoson 25 mg dosed group had NASH at baseline, as compared to none in the placebo group, which comprised of patients who had NAFLD without NASH at baseline. Following 12 weeks of treatment, all NASH cases were resolved in patients treated with 25 mg of Namodenoson, as compared to new NASH that developed in the placebo group representing 5% of that population, with p<0.009. NASH was evaluated by FibroScan-AST (FAST) score, a noninvasive marker of NASH, the severe form of NAFLD (equivalent to biopsy findings of NAS≥4, F≥2), measured by FibroScan elastography, CAP and serum AST.

Decrease in Body weight
A linear decrease in body weight was recorded in the 25 mg and 12.5 mg Namodenoson groups.

A3 Adenosine Receptor (A3AR)
The A3AR biomarker was stable, demonstrating the presence of the receptor after chronic treatment and reflecting the validity of the target.

Safety
Namodenoson continued to be safe and very well tolerated with no drug emergent severe adverse effects and no hepatotoxicity.

Prof. Rifaat Safadi of Hadassah Medical Center, the Principal Investigator of the study commented:

“We are very pleased with these compelling data. The next clinical trial protocol to advance Namodenoson in the treatment of NASH and NAFLD is now being developed. With the clear need for approved drugs in this indication, I believe distribution partners for Can-Fite will likely take notice of these results.”

The following slide summarizes key NASH program highlights





Upcoming Milestones
The following are the milestones the company lists for the rest of 2020 including two Phase 3 readouts in 4Q 2020.

Pipeline
CANF's combined addressable markets for Piclidenoson (rheumatoid arthritis and psoriasis), Namodenoson (liver cancer, NASH), and CF602 for erectile disfunction indications exceed $100 billion as seen in the company's most recent corporate presentation:


Can-Fite's pipeline alone should reward the company with a $300 - $500M market cap. Compare this to the current market cap of less than $40M. There is a huge disconnect here, but a successful Phase 2 COVID-19 clinical trial will help bridge the gap. Also, many of the current high fliers on COVID-19 speculation will not be able to sustain higher valuations if their trials are not successful and/or COVID-19 becomes a non-issue in the future. CANF, on the other hand should be able to sustain higher valuations on the promise of its exciting pipeline and potential blockbuster partnerships to help advance NASH and other programs.

Partnerships
The company has successful inked several corporate partnerships and licensing deals with ~$18 M received to date:



Financials
On June 10, 2020 the company announced that it has raised $8M by entering into definitive agreements with several institutional and accredited investors for the purchase and sale of 3,902,440 of the Company’s American Depositary Shares (ADSs), at a purchase price of $2.05 per ADS, in a registered direct offering. Can-Fite has also agreed to issue and sell to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 1,951,220 ADSs. The warrants will have an exercise price of $2.50 per ADS and will be exercisable at any time upon issuance and will expire four and one-half years from the date of issuance.

On July 6, 2020, the company announced that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 1,705,500 of the Company’s American Depositary Shares (ADSs), at a purchase price of $2.00 per ADS, in a registered direct offering. Can-Fite has also agreed to issue and sell to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 852,750 ADSs. Each ADS represents thirty (30) ordinary shares, par value NIS 0.25 per share, of Can-Fite. The offering is expected to close on or about July 8, 2020, subject to satisfaction of customary closing conditions.

The warrants will have an exercise price of $2.50 per ADS and will be exercisable at any time upon issuance and will expire four and one-half years from the date of issuance.

During the July 23, 2020 investors' call, CFO Motti Farbstein stated that they don't expect further dilution in the near-term since they have ample resources from the recent stock offerings and warrants. The expected runway is 12 to 18 months.

Institutional Ownership
In the last 7 months institutional ownership has increased by 50% according to Fintel. The most recent addition is CVI Investments Inc. reporting a 7.1% ownership in the company as reported on June 19, 2020.

Analyst Opinion
Three analysts have an average BUY rating on CANF stock with a median price target of $7/share

Conclusions
On July 27, 2020, Can-Fite submitted an IND application to the FDA for a Phase II study of its lead drug candidate Piclidenoson for moderate to severe COVID-19 patients. The IND application is based on feedback and guidance from the FDA from prior pre-IND advice.
Can-Fite's Phase 2 COVID-19 drug candidate Piclidenoson, being oral, has significant advantages over competitors using IV-delivered drugs because pills are not dependent on temperature and can be shipped and deployed all over the world quickly where needed providing an enormous logistical advantage in large, global therapy campaigns.
During the July 23, 2020 Investors' Call, CFO Motti Farbstein said that Can-Fite won't dilute in the near-term since they have ample resources from recent stock offerings and warrants. The expected runway is 12 - 18 months.
CEO Fishman believes Can-Fite is significantly undervalued (currently less than $40M) considering that their late-stage pipeline addresses large markets: NASH, liver cancer, rheumatoid arthritis, psoriasis, others
Can-Fite's pipeline alone should reward the company with a $300 - $500M market cap. Compare this to the current market cap of less than $40M. There is a huge disconnect here, but a successful Phase 2 COVID-19 clinical trial will help bridge the gap. Also, many of the current highfliers on COVID-19 speculation will not be able to sustain higher valuations if their trials are not successful and/or COVID-19 becomes a non-issue in the future. CANF, on the other hand should be able to sustain higher valuations on the promise of its exciting pipeline and potential blockbuster partnerships to help advance NASH and other programs.
Speaking of the NASH program, Can-Fite is steadily delivering stellar, statistically significant results while major competitors are dropping out of the race. I would not be surprised if large pharma is not aware of Can-Fite's progress in this area of significant unmet need.
Intercept Pharmaceuticals announced in June that the Food and Drug Administration had said that the benefit of its proposed NASH treatment didn’t outweigh the potential risks. Just this week, the French biotech Genfit, which had been expected to bring one of the first NASH drugs to the market, said it is getting out of the race altogether. In a statement this week, Genfit said it was ending a Phase 3 clinical trial of its drug elafibranor in NASH patients. In May, the company had said that an interim analysis had found that the study had failed to meet its primary endpoint.
With over 50% institutional investor ownership, the company has a float of less than 10M shares. Analysts have assigned a $7/share market cap to CANF stock.
One company that reminds me of CANF's short-term upside is Capricor (NASDAQ:CAPR). Both companies are led by aggressive and focused ladies, both therapies address cytokine storm, but the biggest difference is CANF's monster pipeline compared to proportionally miniscule CAPR pipeline. CANF is at a similar point where CAPR rocketed from $2 to $11/share upon positive COVID-19 therapy reports. Time will tell if this will be the case.
I encourage investors interested in CANF stock to carefully review all the risks and uncertainties as detailed in the company's filings with the SEC.
Disclosure: I am/we are long CANF.

https://seekingalpha.com/instablog/50857529-johnsoriaknows/5483943-canf-waiting-for-fda-approval-of-ind-for-phase-2-covidminus-19-trials-using-oral-anti-viral