Galectin Therapeutics Inc. (NASDAQ:GALT)

Galectin Therapeutics was founded to turn new discoveries in sugar-based human biology into working therapies. The company owns a unique carbohydrate-based technology aimed at using complex sugars to target cellular receptors called galectins.

Galectin’s story starts with one of its founders, Russian scientist Anatole Klyosov. Klyosov headed a laboratory at the USSR’s Institute of Biochemistry. While there, he led research on complex plant sugars. After the fall of the USSR, he came to work in Harvard’s medical school, where he combined what he had researched previously with new discoveries being made into a recently discovered class of galectin cell receptors.

The company is developing a compound derived from this research, called belapectin. Belapectin is a complex sugar molecule, a glycopolymer that binds to galectin-3, a protein involved in disease processes of the liver and the progression of cancer.

Galectin Therapeutics is currently embarked on a Phase 2b/3 trial for liver cirrhosis caused by nonalcoholic steatohepatitis (NASH), sometimes known as fatty liver disease.

As NASH progresses, the liver becomes fibrotic — that is to say that collagen fibers build up as they do in scar tissue. As the fibrosis worsens, it can eventually cause liver failure and death unless the patient receives a liver transplantation.

NASH is associated with obesity and diabetes. It is considered to be a silent killer and it affects up to 16 million Americans, with numbers rising fast.

Galectins are strongly associated with liver fibrosis receptors being upregulated in hepatic cells. In past studies, blocking galectin prevents further scar tissue formation.

There is currently no treatment for NASH cirrhosis, and the market opportunity could be huge. Deutsche Bank has estimated that the NASH market could be worth as much as $30–40 billion by 2025. A working therapy in this deadly condition would be profitable indeed.

As I mentioned, Galectin is currently bringing its belapectin therapy through Phase 3 placebo-controlled trials for NASH cirrhosis. The first patients were enrolled in June and will be tracked through 54 weeks. Results from the 2b portion of the trial are expected in the first half of 2023.

The primary endpoint includes measuring change in blood pressure in hepatic blood vessels. This pressure tends to rise as cirrhosis worsens. In past trials, belapectin has shown a statistically significant reduction in this measure.

The trial also has secondary endpoints to determine if belapectin is working. Cirrhosis is associated with the development of esophageal varices, which lead to swelling and bleeding as liver function decreases and symptoms develop. Changes in the esophagus will also be measured as part of the trial. Liver biopsies will be used as a secondary endpoint as well. Finally patients will be tracked for liver-related complications.

Belapectin is also in Phase 2 trials in NASH-advanced fibrosis, a less severe disease state.

The compound is also being studied as a cancer treatment. Belapectin has shown promising early data in patients with advanced melanoma.

Cancer cells use a variety of methods to survive and grow. One of them involves blocking the immune system, which is designed to detect and destroy mutant malignant cells.

Big, successful immunotherapy cancer drugs like Keytruda, Tecentriq and Yervoy, as well as others in development, help T cells by blocking inhibitory inputs or stimulating them. But galectins can inhibit the efficacy of these drugs.

That’s because cancer cells have another way of blocking the attack of T cells. They secrete galectins, which act like a shield or defense mechanism.

Belapectin blocks galectins, so there is a big opportunity in helping other immunotherapies like Keytruda work with greater potency in cancers of the head and neck or melanoma.

The compound is in a Phase 1 trial for melanoma and head and neck cancer in combination with Keytruda to better quantify its effects.

Galectin Therapeutics has major blockbuster potential in NASH and cancer, but the company has also turned toward treating psoriasis with its “miracle sugar.” Patients in past trials who also had severe psoriasis saw their condition amazingly clear up. Belapectin’s demonstrated safety data to date led Galectin to launch into trials for this condition. Right now, the compound is being studied in Phase 3 trials for patients with moderate-severe disease.

Galectin has built a patent wall around its discoveries, building an IP portfolio around belapectin of 77 granted patents with 27 pending. Patents include composition of matter for complex carbohydrates for the treatment of fibrotic and other disorders as well as small-molecule galectin-3 inhibitors.

Is the Options Market Predicting a Spike in Galectin Therapeutics (GALT) Stock?
,Zacks•September 18, 2018
Investors in Galectin Therapeutics Inc. GALT need to pay close attention to the stock based on moves in the options market lately. That is because the Sep 21, 2018 $12.00 Call had some of the highest implied volatility of all equity options today.

What is Implied Volatility?

Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other. It could also mean there is an event coming up soon that may cause a big rally or a huge sell-off. However, implied volatility is only one piece of the puzzle when putting together an options trading strategy.

What do the Analysts Think?

Clearly, options traders are pricing in a big move for Galectin Therapeutics shares, but what is the fundamental picture for the company? Currently, Galectin Therapeutics is a Zacks Rank #3 (Hold) in the Medical - Drugs industry that ranks in the Top 43% of our Zacks Industry Rank. Over the last 60 days, one analyst has increased their earnings estimates for the current quarter, while none analysts have revised the estimate downward. The net effect has taken our Zacks Consensus Estimate for the current quarter from a loss of 11 cents per share to a loss of 10 cents in that period.

Given the way analysts feel about Galectin Therapeutics right now, this huge implied volatility could mean there’s a trade developing. Oftentimes, options traders look for options with high levels of implied volatility to sell premium. This is a strategy many seasoned traders use because it captures decay. At expiration, the hope for these traders is that the underlying stock does not move as much as originally expected.