Algernon Pharmaceuticals Inc (AGNPF)

[Money $hot]

When you are done reading the attached article ask yourself where would we be now without the global pandemic having pivoted the company off IPF/CC and full steam ahead for COVID-19?

Well first and foremost the company would be stuck in the mud in AU/NZ awaiting it's first data readout since the takeover of Breathtec Biomedical back in 2018. Think about that for a minute. Common shareholders would likely not have seen it's 1st data readout for a 20 person clinical study in nearly 4 Years! From October 2018 to likely Q1 and/or Q2 2022 for IPF/CC Final Data Readout in AU/NZ.

It a colossal failure by any measure of corporate leadership in Bio World.

But for the 100 year global pandemic and Doc Williams digging deep into the data AP would probably be a sub penny stock company. It's not a stretch. We've seen 3 cent shares before. So here's the headline story where "Nash Pharmaceuticals" dodged a bullet!


Biotechs Can’t Cure This Liver Disease. The Latest Failure Crushed the Sector.
By Josh Nathan-Kazis
May 25, 2021 11:07 am ET

The dream of a drug to treat the condition known as NASH took yet another wallop on Monday. Once imagined as a golden goose for biotech and big pharma, NASH trials have ended in disappointment after disappointment in recent years.

The latest came when a firm called NGM Biopharmaceuticals (ticker: NGM), which had a market value of $2.2 billion as of Friday, announced early Monday that its Phase 2b study of its experimental drug aldafermin as a treatment for NASH had failed.

The company said it would stop testing aldafermin in patients with moderate and advanced liver fibrosis—symptoms of NASH.

“Given the failure to meet the primary endpoint, we have decided to shift resources that had previously been reserved for a Phase 3 F2/F3 NASH development program toward advancing our other programs,” the company’s CEO, David Woodhouse, said in a statement.

NGM stock dropped 40.7% on Monday. So did shares of other companies still pursuing NASH therapies, including Intercept Pharmaceuticals (ICPT), which was down 4.5%, 89bio (ETNB), down 14.2%, and Madrigal Pharmaceuticals (MDGL), down 3.2%.

“These data from NGM are an important reminder that the biology in NASH is complex and still poorly understood,” wrote Cantor Fitzgerald analyst Emma Nealon in a note out Monday.

NASH, or nonalchoholic Steatohepatitis, once proved irresistible to drug makers. The condition, which describes a very fatty liver, can lead to liver scarring, known as fibrosis, which in turn can lead to liver cancer or decompensated cirrhosis. It’s thought to impact a large portion of the adult population in Western countries, which made it a promising commercial proposition, and nearly every big pharma company had a NASH program of its own.

As Barron’s noted in December of 2019, however, few of the people who suffer from NASH will notice it over the course of their lifetimes. NASH does not appear to cause symptoms until its final phases. And people suffering from the most serious forms of NASH are more likely to die of a heart ailment than of NASH.

At the time, Barron’s argued that investors should be skeptical of the rush to treat NASH. Since then, one NASH program after another has disappointed.

Intercept cut staff in September after the U.S. Food and Drug Administration rejected its application for approval of its NASH drug. Another company, Genfit (GNFT), which was at one point on track to bring one of the first NASH drugs to market, dropped its NASH programs entirely after an interim analysis of a Phase 3 showed that its NASH drug wasn’t working.

The latest disappointment, from NGM, took analysts by surprise. “The results are a surprise given it was a potent drug and generally expected to be positive,” Jefferies analyst Michael Yee wrote in a note out Monday.

The NGM study’s primary endpoint, which failed to achieve statistical significance, was improvement of liver fibrosis in patients by one stage. Statistical significance was achieved on some secondary endpoints in the study. That led some analysts to note that the improvement of fibrosis endpoint, which is measured using a biopsy, remains a major hurdle. Companies use that endpoint because of FDA guidance.

“We think the consistent [statistically significant] benefit on non-invasive markers suggest biological improvement, not captured by fibrosis histology,” wrote Cowen analyst Ritu Baral in a note out Monday. “This sets up an existential question about the NASH regulatory path.”

In other words: Maybe the reason these NASH trials keep failing is that the FDA is asking companies to measure the wrong thing.

Regardless, investors seem fed up with the whole field. After the selloff on Monday, few of the NASH stocks were showing any life Tuesday morning. Though NGM stock climbed 1.5% as the market opened, 89Bio shares were down another 3.9%, while Intercept stock dropped another 2.5%, and Madrigal shares fell another 0.9%.

https://www.barrons.com/articles/biotechs-liver-disease-nash-sector-tumbles-51621955113

Full stop

Was it luck that AP chose to ultimately roll out NP-120 IPF/CC as it's 1st lead drug or possibly AP saw the writing on the wall and scrapped NASH all together? My best guess moving forward is NASH is at the back of the pipeline pack possibly never to be mentioned again.

The Glitz and Glam of Show Business

algernonpharmaceuticals.com/wp-content/uploads/2018/01/Algernon-NASH-Congress-2019.pdf

You be the judge.

Peace.

M$

Outro