Miami, FL – September 19, 2018 (EmergingGrowth.com NewsWire) — EmergingGrowth.com, a leading independent small cap media portal with an extensive history of providing unparalleled content for the Emerging Growth markets and companies, reports on Galectin Therapeutics, Inc. (NASDAQ: GALT).
Like clockwork the bears will come out of hibernation because it’s clinical trial time. This article is going to explore the main bear theses on Galectin Therapeutics (NASDAQ: GALT). Galectin Therapeutics has had a rocky past and therefore has been a perfect target for notable biotech commentator Adam Feuerstein, a journalist at STAT. He has a twitter following of close to 80 thousand people and follows an incomprehensible number of biotech companies. How can one man know so much? Is he a Jim Cramer clone? The real question investors want to know is: does he move markets? The answer is “yes,” but is there substance? How does he get his information so fast? Adam does both positive and negative pieces, and his work is very controversial and generates buzz, but his track record, like everyone else, is not perfect.
Galectin Therapeutics has been a prime target of Adam’s since they promoted their stock years ago, in order to raise money from an offering. The biggest question is: have they used that money to produce an impressive drug? Another way to phrase this question is: was the stock “pumping” genuine?
According to Adam Feuerstein, definitely not. Here’s the top eleven reasons why many bears may think that Galectin Therapeutics has not developed the fibrosis, cancer, or autoimmune treatment silver bullet.
- It’s apple juice.
- They “data mined the f–k” out of it.
- Insiders are selling stock.
- Failure to meet NASH endpoints. DOSING
- Cancer data lacks statistical relevance.
- The CEO/CMO recently resigned.
- Only $11M cash in the bank. Dilution is imminent.
- Failure to Reach Endpoint in 2 clinical trials – FX and CX trial
- There are only 6 employees.
- The drug didn’t get breakthrough therapy – how can it be that good?
- Richard Uihlein has no experience in clinical stage biotech and pharmaceuticals and equally little experience with publicly traded companies.
1) It’s apple juice.
Well, first of all, it isn’t apple juice. GR-MD-02, a galactoarabino- rhamnogalacturonan polysaccharide polymer, is derived from apple cell walls and hydrolyzed to increase solubility and binding ability. Furthermore Galectin Therapeutics has a proprietary, patented carbohydrate discovery process, allowing them to develop specific carbohydrates for binding to different galectins.
You can drink apple juice all you want or even chug Adam Feuerstein’s Kool-Aid, but you won’t be getting any GR-MD-02, and you certainly won’t be inhibiting any galectin-3. Galectin-3 is differentiated in structure compared with other galectin proteins, and therefore it has behaves differently in the body, and has a different binding affinity for different geometries of carbohydrates, due to its unique carbohydrate recognition domain. Who would have thought that a galactose-binding lectin would bind to a carbohydrate, a polysaccharide? The notion that the drug can’t work because it comes from such a simple source is unfounded.
2) They “data mined the f–k” out of it.
Galectin Therapeutics’ GR-MD-02 was found to statistically significant in treating non-alcoholic steatohepatitis cirrhosis patients without esophageal varices. It successfully reduced their hepatic venous pressure gradients. However, the HVPG of patients with varices decreased on average, but not in a statistically significant manner.
Varices? What do the varices have to do with anything? Did the treatment also work in the subgroup of patients with long noses? Pinocchio said it worked on him!
Well, varices affect the pressure gradient of the liver. Their presence diverts blood flow around the liver, thereby reducing blood flow through the liver. Therefore, according to simple fluid mechanics (we are not accounting for blood being a shear thinning fluid, so that our analysis is simpler – the concept is still applicable), we can deduce that the reduction in overall liver blood flow will result in less of a change in HVPG compared to liver function/fibrosis.
Here’s another way to think about it. Think of a clogged dam. The water level rises until the water starts spilling out over the top of the dam. Even if the clog is partially removed, it might not increase the flow rate quite enough to bring the water level way back down to normal levels. It’s likely that the improvements to cirrhosis patients without varices existed. They were just not statistically relevant when measured via HVPG. It is possible that a longer treatment period would continually, slowly reverse fibrosis or cirrhosis, as the disease itself takes decades to develop.
3) Insider selling
Yep, they are selling – but you have to look at who is selling. These insiders have some of the worst track records when it comes to selling stock, and they are Peter Traber fans. In March before the shareholder meeting to elect new directors they signed up for a 10b-5 plan. They cannot change this plan unless of course they like being sued. The lack of vision in setting price targets serves to demonstrate just how bad Traber was at valuing the company and why his departure was so welcome. Even though these are some of the first insider sells its very helpful to look at their track record during the ATM sales. It is nothing short of abysmal, because they drove the stock down from $6.00 to under $1.00 giving the company a massive hit of dilution at $1.00. These guys have a history at selling at the wrong time. Imagine following the track record of fund mgr Peter who loses on 99% of trades he does and then a friend of your said “hey this fund manager is buying this stock” and encourages you to get some. That means there is a 99% chance that they are selling at the wrong time. Now look at Uihlein confidant Joel Lewis with a small insider purchase as a token of his support. Don’t let the Elvis impersonator’s antics distract you from the most important insider, Uihlein, who hasn’t sold even one share.
4) Failed to meet the NASH endpoint
If they failed to meet the endpoint, does it really matter in the grand scheme of things? NO – because the FDA granted them the opportunity to do a phase 3. The reason you want to hit your endpoint is because then there is a higher chance the FDA will allow you to move forward with a trial. If they hit their endpoint they would have been awarded Breakthrough Therapy Designation (BTD). The irony is that like a game show when you lock in your answer or an endpoint with the FDA you cannot change it. You can’t go back and say wait I wrote this answer first and then I changed it. Had they chose gastric varices as a primary endpoint they had statistical relevance and the FDA would have been obliged to provide BTD. There are instances when a drug might hit its endpoint but the FDA makes you go back and do more safety testing. Making your endpoint in a phase 2 trial is not as important as moving forward with a phase 3 trial design. When the FDA acknowledges that you can move forward with phase 3, that suggests the data was good.
5) Cancer Data Lacks Statistical Relevance
What makes a dataset statistically relevant? Differences of mean, lack of variance, and large enough sample size to prove it. So, are GALT’s cancer results relevant? GR-MD-02 has only been tested in less than 10 patients so far, with results posted. However, with a dose dependent trial, and 100% (3/3) of Keytruda/GR-MD-02 patients responding to higher dosage of GR-MD-02 (4 mg/kg) compared to a 33% response of Keytruda alone, you don’t need much of a statistical analysis to come to a reasonable conclusion. The even higher dose of GR-MD-02 (8 mg/kg) may even have a higher number of complete responses and a comparable ORR. Furthermore, look at the before and after pictures of the cancer patients, and tell that to the patients that they aren’t statistically relevant. While GALT’s cancer combination immunotherapy results are statistically relevant, the naysayers are still sadistically relevant.
6) The CEO/CMO recently resigned.
The CEO/CMO was Peter Traber. He had an Elvis themed wedding and that is one of Feuerstein’s favorite digs on the guy. Traber was a decent guy, but a control freak, which led to his resignation. He thought of himself as a storyteller and an educator but all he did was bore investors with concepts well above their heads. His LinkedIn profile showed that he was in full control of GALT and its press releases, and after dealing really poorly with Feuerstein, he got into a shareholder lawsuit that vindicated GALT, but was a drag on the press releases ever since. Although Traber was a good scientist, the “apple juice” is fully developed and manufacturable, ready for a phase 3 trial in NASH cirrhosis, and therefore easily be managed by someone else.
7) Only ~$10M cash in the bank. Dilution is imminent.
This claim is blatantly false. Galectin’s current cash burn rate is around 12 M per year with a trial running. No trial right now just a couple of executives planning the phase 3 NASH trial. They also have a $10 million line of credit agreement with their board chairman, who must have the company draw down on it so he can earn half a million shares in warrants at $5/share to go along with the other half a million warrants for opening the credit line. Therefore, Galectin Therapeutics cash position is more along the lines of $25 million. They have more than enough cash to continue operating while they negotiate a partnership.
8) Failure to Reach Endpoint in 2 clinical trials – FX and CX trial
Endpoints do matter but as previously stated they are a means to an end. Additionally with the passage of the 21st Centuries Cures Act not locking in the right endpoint of a study cannot prevent a drug treating the largest unmet medical need from being approved. Failure of these endpoints of a completely unnecessary FX trial and a CX trial that failed due to the legalist lock in rules of the FDA means nothing on whether or not the drug works. Is there efficacy and can they run a clinical trial to meet their endpoint? The answer is a resounding YES if you believe in statistics. Recently the company announced that their primary endpoint would be the formation of varices. In the 2mg/kg group which isn’t even the optimal dosage they achieve no new varices and given that it was statistically relevant when a larger group is tested in Phase 3 the same results are expected which will mean that GR-MD-02 has the potential to be the first drug approved for the treatment of NASH Cirrhosis.
9) There are only 6 employees.
You have to concede this to the shorts. There are maybe 4 employees and 2 independent contractors. They really do a lot of contract labor and pay the 4 employees very handsomely.
10) The drug didn’t get breakthrough designation. How can it be that good?
The truth is none of this matters because the company is for sale and it’s not trading like it’s going to get purchased in a couple of months after the phase 3 design is completed. Galectin Therapeutics looks a lot like the situation two years ago at Aerie Pharmaceuticals. Will Adam Feuerstein’s prediction prove to be dead wrong, yet again?
11) – Richard Uihlein has no experience in clinical stage biotech and pharmaceuticals and equally little experience with publicly traded companies.
Fact – Dick Uihlein inherited a small fortune which on top of his Stanford degree, he turned into nearly an estimated $5 billion company called Uline.
Question – Why would Uihlein devote time to an obscure publicly traded biotech company?
With a guest cottage grander than most people’s dream house, he accepts the role of Chairman of the Board of Galectin Therapeutics because he can lead a company with a compelling scientific compound and intellectual property into a variety of medical applications that can make profound and life saving differences in the lives of millions of people.
This isn’t bad for a guy who never needed to turnaround another company in his career. Plus, he’s never sold any of his millions of shares of GALT stock. Dick Uihlein is a man of determination, success, and perseverance, and chances are good that he turns Galectin Therapeutics into a big success story.
Reasons for Success:
Liver Cirrhosis – Serious Unmet Need
The Drug Works
Galectin performed a rigorous assessment of the response to therapy by evaluating the percent of patients who had a reduction of HVPG from baseline (Responder Analysis). Responders were defined as having reductions of HVPG from baseline that have been shown to be clinically significant, an absolute reduction of ≥ 2 mmHg of HVPG from baseline or a ≥ 20 percent reduction of HVPG from baseline. Based on reduction in absolute HVPG, patients without varices who received a 2 mg/kg dosage of GR-MD-02 showed a statistically significant greater percentage of responders than those without varices in the placebo group (44 percent versus 15 percent, p=0.02). The same statistically significant results were seen when responders were analyzed based on a ≥ 20 percent reduction from baseline HVPG (40 percent versus 15 percent, p=0.03). Patients in the 2 mg/kg dosage group also did not develop varices which is a potential registration endpoint for the upcoming Phase 3 Trial.
The Drug Works
Providence Portland Medical Center is conducting a study with GR-MD-02 in combination with Yervoy® (ipilimumab) in a Phase 1B study of patients with metastatic melanoma. The study was prompted by findings from a preclinical study led by tumor immunology expert William L. Redmond, Ph.D., of the Providence Portland Medical Center’s Earle A. Chiles Research Institute (EACRI). The data is expected by end of summer (which is this Friday, 9-21-2018) per the most recent 10Q filing.
The Drug Works
The company demonstrated in 2 pilot studies that GR-MD-02 works on Atopic Dermatitis and Plaque Psoriasis. The indications of efficacy are in human and preclinical trials. There are over 10 peer reviewed articles that link galectin-3 as the axis of the NASH disease and countless articles that talk about the galectin-3 and its role in cancer and other immunological diseases.
There is just too much evidence to ignore that Galectin’s GR-MD-02 is a serious contender for two serious unmet need indications that are worth billions each. The likes of Fuerstein want investors to focus on Apple Juice theories while clinicians are focusing on Galectin’s GR-MD-02 as an important treatment for both liver cirhossis and cancer for the near future. Expect the shares to trade to the $20 level near-term with positive results. Look at what Viking Therapeutics (NASDAQ: VKTX) did and their drug only works on the Fat pillar of NASH. The only problem with that statement is that now we are comparing a one indication drug company to arguably the largest ever platform drug. GR-MD-02 can be in combination with each and every known cancer treatment in the world because every cancer has on core truth. It cannot exist if the immune system is working properly and inhibiting galectins restores order to the body’s immune system and a natural fit for every single cancer therapy.
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