Yes, let’s hope so. Seem the closer we get the more vultures show up to try manipulation the share price.
If you have read some of the ghost of Tom Goad’s post on that sa article yesterday. He does a really good job.
https://seekingalpha.com/article/4243443-cytodyn-good-true
Here is one
If you have read some of the ghost of Tom Goad’s post on that sa article yesterday. He does a really good job.
https://seekingalpha.com/article/4243443-cytodyn-good-true
Here is one
Quote:Completely fair take. I think it takes a deep dive into the history of CCR5 inhibitors and some understanding of the company's timelines to figure out why a deal hasn't occurred yet, but it now makes sense to me. It took me several years to reach the understanding and comfort level that I currently have with the company's financial situation, so I'm happy to share my perspective when I can. I actually posted on this at length on another article recently, so I'll copy and paste here for your convenience.
It's something of a long story, but in short... CCR5 inhibitors were all the rage for HIV a few years back, except they didn't tend to turn out that great. Maraviroc ($MRK) is approved, but has relatively low response rates and still struggles with toxicity. Vicriviroc ($PFE) never even got approved. There was promising cancer data generated in 2012 by a joint study from those two firms (led by Richard Pestell, now CMO at $CYDY), but that never advanced very far. There is currently a study going on with Keytruda and maraviroc, but CytoDyn IP would prevent it from being commercialized.
Study: www.fiercebiotech.com/...
IP: patents.justia.com/...
So leronlimab (nee Pro 140) was bought off the scrap heap a while back, and nobody gave it much of a chance to get anywhere. The FDA wanted a trial run for combination therapy for HIV before the company could advance it for monotherapy, presumably because the combo market is basically salvage (multi-drug resistance) patients that constitute an unmet medical need. That took time and money, and early mono trials showed middling results. However, thanks to the safety profile (no serious adverse effects noted to date in any trial over hundreds of patients and years of use), they realized that they could up the dosage, which turned in better and better HIV results. Most recently, their phase III combination therapy trial met primary endpoints, and an investigational phase IIb/III monotherapy trial showed 90%+ response rates as dosages increased.
Combo endpoints: www.cytodyn.com/...
Mono efficacy: www.cytodyn.com/...
But the potential introduction as a combination therapy was never a threat to any BP's cash cow, and until recently with the dosage escalations, monotherapy was hitting middling response rates as well. Therefore, nobody jumped at an acquisition or partnership.
In the meantime, Dr. Pestell (of the 2012 joint Merck/Pfizer study) learned about leronlimab and it's efficacy/safety profile as a CCR5 inhibitor. He approached the company about studying the compound independently as far back as maybe 2016 - the exact timeline on that is a bit unclear. His results impressed him, and CytoDyn bought Pestell's company - and IP - in 2018.
Acquisition: www.cytodyn.com/...
The cancer indication is important because once the company knew that a cancer indication was a real possibility, they weren't going to sell the company or license off the drug for peanuts. By the time the results from monotherapy trials showed it's potential as a disruptor in the HIV market, cancer was already on the table. No company is going to pay cancer money if the only thing proven is HIV, and CytoDyn won't accept HIV money for a drug with cancer platform potential. You're at a stalemate. So they've been selling shares to raise money for years, on terms that encouraged investors (economically, not explicitly) to sell the shares and keep the warrants. That, plus it's residence on the OTC, has kept the share price depressed through clinical successes, etc.
All of that said, they have enough cash and remaining authorized shares not yet issued to fund the current BLA for combination therapy and advance their first cancer trial, in triple negative breast cancer. If interim cancer data comes back positive, BP will likely be forced to move on some sort of a partnership. That hypothetically eliminates the need for further funding rounds, which breaks the current capital cycle, and should bring CytoDyn closer to a market valuation.
All of this ignores that the drug may also basically cure GvHD, and that Pestell's company brought over a prostate diagnostic test that is an improvement over current options and could hit the market in late 2019 or early 2020.
GvHD: www.cytodyn.com/...
Diagnostic test: www.cytodyn.com/...
I'd recommend watching a recent presentation by the principals of the company, CEO Dr. Nadar Pourhassan and CMO Dr. Richard Pestell, to better understand the progress the company has made.
Presentation: noble.mediasite.com/...
