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OK, folks, not sure how many follow this board or care, but I do want the pleasure of saying "I told you so" next year. What the hell is sarcopenia, you ask, and why make a drug for it? Here's a headline from 2017:
The CDC recently recognized sarcopenia as a reportable medical condition necessitating better screening and diagnosis of this geriatric syndrome. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576154/
CDC recognition means the treatment can now be medically diagnosed, treated and, most importantly, billed! And it has its very own ICD-10 billing code. Sarcopenia article
Excerpt from the article: "Recently, there has been a call to action to systematically address sarcopenia by interdisciplinary organizations such as the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the International Working Group on Sarcopenia (IWGS).4,5 This call to action is due to the association of sarcopenia with increased health care costs, higher disability incidence, and elevated risk of mortality.6,7 The consequences of sarcopenia may include serious complications, such as hip fracture or a loss of functional independence. 8,9 The CDC now recognizes sarcopenia as an independently reportable medical condition. Consequently, physicians, nurse practitioners (NPs), and other associated health professionals within the VA will need to better understand clinically viable and valid methods to screen and diagnose this geriatric syndrome."
As of today, there are NO approved drugs for this newly recognized condition that affects millions. So, MYMD-1 will launch as the only FDA-approved drug that physicians can prescribe for this condition. And it happens to be safe, with none of the toxicity in other TNF alpha blockers that no doctor in his right mind would prescribe for sarcopenia. In other words, a virtual monopoly on treatment of this widespread condition. Not to mention the other indications to follow, like arthritis, MS, and other inflammatory diseases.
MYMD is on sale these days, like a lot a biotech startups. You can thank me later.
The studies demonstrate that MYMD-1 is a highly effective blocker of TNF-a. https://www.mymd.com/news/recap-of-mymd-pharmaceuticals-inc-recent-publications-and-presentations Virtually every drug commercial on television these days is about some form of TNA-a blocker, but with horrific side effects and warnings about multitude of ways the drugs can damage or kill you (all to happy music and smiling people). The home run potential of this stock once MYMD-1 clears Phase 2 is unlimited. This is why investors like Ray Dalio are in the stock.
Lift off in progress.
The MYMD science is out there for all to see, and those who understand it are all in. There is no drug that has this much potential to treat so many diseases. Stocks like this can go from $2.60 to $95.00 in a year or less. Witness AXSM, which does not have a fraction of MYMD’s potential.
We are going to do very well with this one.
Knuts: This appears to be a routine filing associated with the earlier private sale. The form requires a listing of officers and directors. They are not the buyers. But someone likes the company enough to pay $6,000,000 for shares priced at $4.25 in order to get warrants right to buy more at $5.25. That's confidence in the future.
Private Sale at $4.25/share - Proceeds $5,999,999
Somebody with deep pockets just paid $6 million to acquire shares at $4.25, plus warrants at $5.25. https://www.sec.gov/Archives/edgar/data/1321834/000149315222023314/form424b5.htm
In the meantime, buying the dips is proving to be a great strategy. This little gem has $50+ possibility. There is a reason top scientists at Hopkins are all over this. Three peer-reviewed animal studies in prestigious journals, all with positive results. Potential to treat multiple diseases. No adverse side effects demonstrated in Phase I human trial. If you are reading this, consider yourself to be one of the lucky ones with the opportunity to get in before Phase II results are out later this year.
In the meantime, buying the dips is proving to be a great strategy. This little gem has $50+ possibility. There is a reason top scientists at Hopkins are all over this. Three peer-reviewed animal studies in prestigious journals, all with positive results. Potential to treat multiple diseases. No adverse side effects demonstrated in Phase I human trial. If you are reading this, consider yourself to be one of the lucky ones with the opportunity to get in before Phase II results are out later this year.
Shorts are trying to salvage their position on modest volume. May present a good opportunity to pick up more shares.
NEW ANALYST ON BOARD: Analyst Frank Curzio touted MYMD to Charles Payne (Fox Business news) on Monday. This explains the afternoon surge. Look for the August 8th Cryptocurrency video and go to near the end, around 6 minutes.
https://www.foxbusiness.com/shows/making-money-with-charles-payne
Curzio gives two picks, one of which is MYMD. "Same thing as Humera, the number one selling drug in the world." "Under the radar."
It's happening.
Friends: don't expect news. All the news is already out there, in the form of multiple, peer reviewed, scientific reports and prestigious Journal articles showing this compound has the potential to revolutionize healthcare. It's just that until now, no one who matters has noticed, because all biotech firms with no revenue are suspect. The suppression of TFN alpha and associated inflammatory processes, especially without horrible side effects (e.g., like those accompanying Humera) is a holy grail of medicine. MYMD is safe (it breezed through Phase 1) and has been shown to significantly lower TFN alpha.
All biotechs are to some degree a speculative bet. But would you rather bet on a compound that treats some obscure disease (or one type of cancer) or one that might treat every inflammatory disease known to man, from arthritis to diabetes. My money (and it's a big chunk of it) is on MYMD.
The action today suggests that some big hitters are figuring this out. It also suggests that all the sellers are gone.
JOHN MAULDIN ON BOARD!
The legendary economist John Mauldin revealed in a recent article that he is a believer in, and a shareholder of, MYMD. Mauldin is the founder of Mauldin Economics, a financial expert, and NY Times best-selling author. In a March 25 Thoughts from the Frontline article, he summarized the MYMD story and disclosed his ownership interest:
Let’s start with some very new research from a company called MyMD Pharmaceuticals. (Full disclosure: I am an investor but have no other financial relationship with the company.) This is clearly in the fountain of middle age category.
Their drug, MYMD-1 is a TNF-a inhibitor, like Humira and the other monoclonal antibodies (mAbs) that make up a $25 billion market treating multiple serious diseases. Unlike mAbs, which are grown from human or animal cells, MYMD-1 is a synthesized version of a naturally occurring molecule found in plants. It's also safer than the mAbs that come with a black box warning indicating serious risk. Moreover, it doesn’t have to be injected. It is a simple pill and, based on a phase 1 human trial, has virtually no side effects.
The most important thing about TNF-a is that it is a major driver of aging itself.
Link to full article:
https://www.mauldineconomics.com/frontlinethoughts/things-are-getting-better#healthcare
Bouncing back nicely this morning.
Today's selling is low volume and orderly, and dips like this are common with thinly-traded small caps, especially after a big run like we've had. IMO this presents a good opportunity to pick up more of this poorly followed stock. The poor following is going to change. What this study shows is the potential to replace all the exiting biologics (Humira, etc.) with a safer and possibly more effective treatment. This is a "holy s**t" finding for anyone who understands the science:
The current FDA approved TNFi biological drugs selected for the comparative study treat a number of inflammatory and autoimmune diseases, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis, psoriatic arthritis, and more. Acumen Research and Consulting confirmed TNF-a inhibitors are the most prescribed drugs by revenue globally, at $40 billion per year.
“Current TNF-a inhibitors available today, while effective, come with an array of adverse effects and concerns for patients,” said Adam Kaplin, M.D., Ph.D, Chief Scientific Officer for MyMD. “Many have the risk of causing neurotoxicity, as they are unable to cross the blood–brain barrier; this is one of the key differentiators and capabilities of MYMD-1, which crosses the blood-brain barrier. We also found that MYMD-1’s selectivity allows it to only block overactive TNF-a in lymphocytes that participate in autoimmune diseases, leaving TNF-a synthesized in macrophages to be produced to help coordinate the initial response to acute infections. This should remove the increased risk of infection, associated with all TNFi biological drugs used today.”
To summarize for those new to this Board:
1.) MyMD-1 was shown to be effective on Multiple Sclerosis and Hashimoto's Thyroiditis in animal studies at Johns Hopkins University.
2.) Phase 1 human safety trials are complete.
3.) The company holds patents on the use of MyMD-1 to treat virtually all major inflammatory diseases, where billions and billions are spent on pharmaceutical compounds annually.
4.) Big hitters on the MyMD Scientific Advisory Board.
5.) A Pharma Industry insider had loaded up on the the stock out of his own pocket.
6.) Big end-of-day institutional buys the last couple of weeks.
7.) Phase II clinical trials coming soon.
8.) MYMD-1 has no adverse side effects in the animal trials, unlike Humira and the other biologics targeting inflammation.
9.) MYMD-1 is a small molecule that can cross the blood-brain barrier.
MYMD-1 shown to be effective in treating multiple sclerosis in animal studies at Hopkins.
MYMD-1, a novel alkaloid compound, ameliorates the course of experimental autoimmune encephalomyelitis
Justin D Glenn 1, Itzy Morales Pantoja 2, Patrizio Caturegli 3, Katharine A Whartenby 4
Abstract
Multiple sclerosis (MS) is an autoimmune disease that remains in need of effective therapies. Plant-derived medicines have appealing properties for the treatment of autoimmune diseases. MYMD-1 is a synthetic plant alkaloid that has been shown to ameliorate the course of autoimmune thyroiditis. The goal of the present study was to determine whether MYMD-1 would produce similar beneficial effects in a mouse model of MS, experimental autoimmune encephalomyelitis (EAE) induced by immunization with myelin oligodendrocyte glycoprotein. MYMD-1 improved the course of EAE and suppressed activation of effector T cells without causing global immunosuppression or toxicity. These results suggest that MYMD-1 may be of interest for evaluating for the treatment of autoimmune diseases.
Johns Hopkins Medicine Researchers to Present Data on MyMD Pharmaceuticals’ Supera-CBD at the 3rd Annual Neuroimmunology Drug Development Summit
BUSINESS WIRE 10:13 AM ET 4/28/2021
BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.(MYMD) , a clinical stage pharmaceutical company committed to extending healthy lifespan by focusing on developing two therapeutic platforms, announced today that researchers from the Johns Hopkins University School of Medicine will present the results of new research on the company’s compound Supera-CBD at the 3rd Annual Neuroimmunology Drug Development Summit. The poster presentation will discuss the preclinical cannabidiol (CBD) derivative that targets endogenous cannabinoid receptor type 2 for the treatment of psychiatric disorders. The researchers studied the compound in depression and anxiety-related phenotypes in mice.
“This presentation of preclinical research will highlight the potential of Supera-CBD to address unmet needs in psychiatry," said Adam Kaplin, M.D., Ph.D., Chief Scientific Officer of MyMD Pharmaceuticals(MYMD).
Researchers Chantelle Terrillion, Ph.D., Instructor in Neuroscience, and Anupama Kumar, MBBS, Research Associate in Psychiatry and primary investigator on the study, will present findings from preclinical studies on the role of Supera-CBD. Early findings revealed Supera-CBD’s potent anxiolytic properties. The data being presented at the conference also demonstrate that Supera-CBD binds to CB2 with almost four-times the affinity of CBD. Other research has shown that binding to CB2 potentially mediates a number of the therapeutic effects of CBD, including its anxiolytic, antinociceptive, anticonvulsant, antipsychotic, neuroprotective and anti-inflammatory effects.
Details of the poster presentation are as follows:
Title: Supera-CBD: A Novel CBD Derived Drug Candidate
Abstract Number: 1858
Date and Time: April 28, 2021 at 4:15 p.m. ET.
Access to Poster: The poster will be available at the conference website’s media library as well as on MyMD.com/pipeline/supera-cbdafter the time noted above.
Big pharma player on board. Form 4 filing by Craig Eagle. He had 1,250,000 pre-merger options for private MYMD shares, now for 482,372 sh of public MYMD at $2.59/sh. "Dr. Craig Eagle, MD, is Head of BioOncology for US Medical Affairs at Genentech. Dr. Eagle has a wealth of oncology experience. He joined Pfizer Australia in 2001 as part of the medical group. In Australia, his role involved leading and participating in scientific research, regulatory and pricing & reimbursement negotiations for compounds in therapeutic areas including oncology, anti-infectives, respiratory, arthritis and pain management. In 2003, Dr. Eagle led the worldwide development of Celecoxib in oncology to oversee the global research program. He was responsible for the global research plans and teams for Irinotecan and Dalteparin. He served as Head of the Oncology Therapeutic Area Global Medical Group for Pfizer, including the US oncology business. Dr. Eagle also led the integration of the Pfizer/Wyeth oncology businesses and portfolio. Over his 17 years with Pfizer, he held several roles, including Head of the Global Medical Affairs Oncology and Outcomes Research organization, managing an international group of medical directors and researchers involved in all phases of clinical studies and outcomes research. He then transitioned into a role as VP of Global Oncology Strategic Alliances & Partnerships, serving on the Global Oncology Business’s executive leadership team. He attended Medical School at the University of New South Wales, Sydney, Australia and received his general internist training at Royal North Shore Hospital in Sydney. He completed his hemato-oncology and laboratory hematology training at Royal Prince Alfred Hospital in Sydney, and was granted Fellowship in the Royal Australasian College of Physicians (FRACP) and the Royal College of Pathologists Australasia (FRCPA). After his training, Dr. Eagle performed basic research at the Royal Prince of Wales hospital to develop a new monoclonal antibody to inhibit platelets."