Galectin Therapeutics Inc. (GALT)

[biotech2010]

GALT has initiated the adaptive Ph2b/Ph3 with a very favorable primary end point (progression to Varices)-it is now posted on the FDA Clinical Trials site:
https://clinicaltrials.gov/ct2/show/NCT04365868

This end point is a duplicate of the positive results in the original Ph2 CX trial and points to a strong likelihood of a success in the Ph3

I'm surprised that GALT hasn't done a Press Release yet about this but it's possible there is additional news that will be included with this.

Stock is up 13% today and this is the likely reason for that increase.

[buckysherm]

So minus cash the “value” of the company is only $50 Mill. Wow.

[Chess Master]

Very few posts. Pretty sad the company doesnt talk. There is nothing to talk about $50 mil in cash just sitting there.

[Minitruckin]

Any update on ph where you been

[Minitruckin]

Can you pm what you think phil expect pps will be, in send over your phone number

[EponymousKook]

Bucky, I hope you didn’t completely abandon CYDY. Otherwise, I fear you have backed the wrong horse.

[buckysherm]

Once the correct number of patients reach 1 year or so, there will not be much down time while results are compiled. But FDA will require much too long to “think about it”. This was expected to take 3 years anyway. 1 or 2 qtrs of trial length added unfortunately.

[Amatuer17]

So here is combo of bad news

1. The feedback was received in late October - this means FSA met their deadline of 75 days to give comments. Co decided to hold that news till Good news related to Siemens came out and they had to give it in 10-q

2. Surrogate end point changed - this means they have to add some specific end point - this may add to duration of trial
“. In its comments, the FDA seemingly is departing from its earlier implied potential support of the use of progression to varices as a surrogate endpoint for accelerated approval. “

3. The protocol is being redesigned with help of experts - this means resubmission of new protocol - the 75 day clock starts again

4. I mis-read about new trial but the effect is the same. The new design will be conducted as 2 part trial

Part A - Adaptive portion with interim futility analysis allowing early termination of trial in case of not good interim results

Part B - this is being now called as real phase 3 study and will have parameters adapted based on results of part A. It will have more criteria, more inclusion, 2 year dosing for at least 500 patients.
If the part B or P3 shows good results, it could go for approval or need another P3 study.

4. Co expects to dose 1st patient in Q1-2020 but we do not know what is the patient numbers and duration required for part A of study meaning it is really 2 studies.

All this mess- co is screwed up now. Assuming Q1-2020 start, the interim analysis will be for at least 1/3rd patients (170-200) to complete at least 24-36 weeks of treatment - so we are looking at 18 months for interim futility analysis. Then if positive results continue all patient enrollment and 104 week treatment - total time 3+ years.

This is a very very long path - unless someone buys this company, not a good candidate for investment till interim analysis.

Welcome year end tax losses.

[Chess Master]

REALIZE FDA DELAY = VERY POSITIVE - We dont know what they filed with the FDA because they never told us being the wonderful communicators that they are. what we do know is that whatever it was it was probably bad. The track record GALT has on clinical trial design is horrendous. RESULTS are Phenomenal but the DESIGNS always suck. They were going to probably have a 2 year study with a read out in year 3. Now shareholders have a chance. they could stop the trial on some people early once they show efficacy.

Shlevin messed the timing and trial up dont give him or the other directors a chance - do not vote for them.

[Pennyzilla]

WE LIKE THE CHARTS - Keep em coming

[ClayTrader]

lol

[Chess Master]

Typical short view point. Wish his self promotable material would stop. His charts never work. This is why shorts love his work.

[buckysherm]

I didn’t see another study for dosing. Just a confirmation of dosing. They still say first patient will be dosed in Q1. So you’re saying the trial will last 6-8 months longer. Traber is still forking the company over long after he’s gone.

[stock_observer_77]

Agree

[Amatuer17]

And sometimes delay in news means serious delays.

New protocol - another study for dosing - add at least 6-8 months to start final phase 3 - from where the money will come from? Don’t know.

In early biotechs with no revenue - the principle is simple - the CEOs announce good results promptly , bad news is delayed and is tried to combined with some other perceived good news.

[buckysherm]

FDA = Forking Delayed Again

[stock_observer_77]

Of course it doesn’t

Read the second paragraph

[Amatuer17]

Actually read the PR - the collaboration is for using data from completed trial and not new trial.
The P2 trial was successful so it makes sense. It does not say if the P3 protocol was accepted or there were some open issues.

[ClayTrader]

* * $GALT Video Chart 11-11-19 * *

Link to Video - click here to watch the technical chart video

[jimmy667]

As far as Siemens goes it looks like Gilead is out and Galectin is in. GILD drug failed twice in PHASE 3.

[whytestocks]

News: $GALT Galectin Therapeutics Reaches Agreement with Siemens Healthineers to Collaborate on NASH and Liver Fibrosis

NORCROSS, Ga., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Today, Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, announced a collaboration agreement with Siemens Healthineers, a global leader in medical technology, in nonalcoholic steat...

Find out more GALT - Galectin Therapeutics Reaches Agreement with Siemens Healthineers to Collaborate on NASH and Liver Fibrosis

[buckysherm]

Yeah, why would they agree to this BEFORE the phase 3 was set ?

[stock_observer_77]

I'm sure Siemens doesn't

[stock_observer_77]

Siemens think that too???

[buckysherm]

That’s exactly what I thought. That’s exactly what I expect given my investment results.

[Amatuer17]

The delay in announcement seems to indicate that the protocol is not approved.

The 10-q for sept end should come next week and they will have to give business update. The protocol approval is the only activity going on in GALT - so we need some update

[buckysherm]

Sorry, 95 on Saturday.

[buckysherm]

85, 90 ... We have 85, 90 on Saturday ....

[stock_observer_77]

Good luck

[Amatuer17]

Giving advice to sell is sign of cult follower - not an investor who asks questions to verify progress

[stock_observer_77]

You better sell

[Amatuer17]

Very bad for the company

- topline results announced in Dec 2017
- the phase 3 not started even after 2 years
- the P3 protocol is not yet approved by FDA after 80 days - also co has not issued any update - seems FDA has sent the protocol back for changes


“Galectin Therapeutics announced top-line results from its NASH-CX Phase 2 trial in December 2017. The Company is proceeding with plans for its NASH-RX Phase 3 clinical trial program with its galectin-3 inhibitor belapectin (GR-MD-02) in NASH cirrhosis. Plans for the NASH-RX trial were put forward in August via a Type C Written Response Only submission to the U.S. Food and Drug Administration (FDA) with the goal of finalizing the protocol and initiating the clinical trial in the near future”

[buckysherm]

80 days, do I hear 85 days ? Going once ...

[Amatuer17]

No update yet - crossed 75 days

[stock_observer_77]

It’s public info - we will know

[buckysherm]

GALT doesn’t care whether we know about this or not.

[stock_observer_77]

I believe a response is required by FDA by then

[Amatuer17]

Is 75 days official guideline? Cannot find any documentation

[stock_observer_77]

The 75 days are not up yet

[biotech2010]

These guidelines aren't 'favorable' at all for GALT since they focus on Clinical Outcomes, regardless of source, and not progression to Varices.

GALT's original plan was for the Ph3 to have a primary endpoint relating strictly to either reduction in HPVG or the progression to varices. The change to clinical outcomes adds other elements to the discussion that will affect the results since none of them will be helped by GR-MD-02.

Just look at slide 17 from July, 2018 regarding this: https://investor.galectintherapeutics.com/static-files/d114ffca-2367-48a2-99cc-ec0292d18fe1

This change by the FDA is the reason, IMO, why it has taken so long for GALT to finalize the Ph3 protocol.

[buckysherm]

Is no one interested ? It appears that way.

[buckysherm]

75 days would be .... tomorrow ? Sweet dreams.

[Amatuer17]

Here are NASH-CX trial protocol guidelines for P3 - there were written in Jun 2019 as if specifically for GALT.
Not sure anyone is close to P3.

One can see that the inclusion - exclusion
Criteria are stringent - enrollment will be expensive and long process.

https://www.fda.gov/media/127738/download

[Amatuer17]

Interesting report - out of $18 B potential market 62% is for NASH - CX and GALT is only co with P3 ready drug. It is very attractive and overdue to get P3 approved by FDA


https://www.globaldata.com/global-nash-market-set-reach-18-3bn-2026/


“The total size of the non-alcoholic steatohepatitis (NASH) market across the 7MM* is set to grow from $138.4M in 2016 to $18.3bn in 2026 at a compound annual growth rate (CAGR) of 63%, according to GlobalData, a leading data and analytics company.


GlobalData’s report also finds that drugs which are proven to benefit NASH patients with cirrhosis will account for the largest segment of the NASH market. The company expects these drugs to account for 62% of the NASH market in 2026, with total sales of $11.3bn.”

[Chess Master]

The First step is the notice to proceed from the FDA. So I am definitely looking forward to that news like now or maybe next week. They said the beginning of October which is 60 days from their announcement in July. The FDA is required to respond to their letter.

[Amatuer17]

I am hoping something like this deal - not just fda acceptance.
The fda acceptance is just start of trial and it will possibly go for at least 2 more years. So some BP should do the same deal as below


https://finance.yahoo.com/news/akcea-pfizer-inc-announce-licensing-105000501.html

[Amatuer17]

I got from the business update


Galectin Therapeutics Reports Q2 2019 Financial Results and Provides Business Update $GALT https://seekingalpha.com/pr/17599579

[jimmy667]

I see no news to support a 9% jump in price this morning. Rumour of FDA acceptance of the trial protocol maybe? What have other companies spent on Phase 3 NASH? Will $40-50 million be enough to go alone on this?

[jimmy667]

It looks like some are buying the rumour of something. FDA acceptance of Phase 3 protocol maybe.
where do you get $44 million on hand? The June 30 Q10 stated $52 million. Did you reduce that figure by the burn rate? Also they have only S3 registered 1.7 million shares at maximum price of $3.51 for additional $6 million. Seems like very mild dilution for a company with 56.6 million shares outstanding. If your figures are correct of $44 million that would put cash back to $50 million.

[Amatuer17]

The phase 3 protocol was submitted on Aug 5th - this weekend it will be 2 months.
Typically the protocol gets approved in this time.
Is there query from FDA on trial details? Company normally sends updates quickly.