I’ve gotten a few questions in recent weeks about a new ad for Curzio Venture Opportunities ($249/month or $2,500/yr, no refunds), which is Frank Curzio’s “high end” upgrade newsletter, focusing on small cap stocks and stuff like junior miners, biotech and private placements.

And this one’s a doozy, promoting the idea that a tiny company, with a market cap under $150 million, could (eventually) release a drug that is dramatically better than Humira, which is the best-selling drug of all time.

Better yet, there’s news coming soon — an ad always needs a “catalyst” to urge you to act quickly (and therefore to pull out your credit card quickly), and Curzio says this company will be releasing Phase 2 results about this potential blockbuster drug “soon” — and that you have to be in before those results if you want to enjoy the biggest gains.

So what’s the stock? Curzio does have a personal stake here, which might mean he has followed it more closely than most: His young daughter has Crohn’s Disease, which is a nasty autoimmune disease that wreaks havoc on your digestive system, and she’s taking Humira, which has been a Godsend for many patients with rheumatoid arthritis and other inflammatory disease, but also has terrifying side effects. Here’s a bit on that:

“This pill does not block TNF Alpha once it’s already been produced.

“It regulates production at the source – allowing some to roam free… but not too much.

“It’s not trying to blunt the immune system.

“It’s trying to optimize it.

“That’s huge.

“Because the right amount of TNF Alpha doesn’t mean my daughter feels less pain from her Chron’s.

“It means she doesn’t have Chron’s.

“Let me put it another way:

“Humira treats the symptoms.

“And it does so with potentially deadly consequences.

“Humira went from zero to the “blockbuster of all blockbusters” by treating some of the diseases caused by too much TNF Alpha.

“This new one-a-day pill could not only treat them – but cure them.”

And apparently this drug is looking pretty safe so far, per Curzio:

“No serious side effects have yet been reported. And the pill’s developers consider it so safe most of them are already taking it, despite the fact it’s not yet FDA approved.”

What else do we get by way of clues?

“The pill is currently in Phase 2 trials.

“In Phase 1, the goal was to lower the amount of free-floating TNF Alpha in the blood of healthy people.

“It worked.

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“In Phase 2, the goal is to do the same thing in people with chronic inflammation, aka, too much TNF Alpha.”

And when might we hear? Nothing more specific than “soon,” but this is how Curzio puts it:

“Recently, the company announced the pace of its Phase 2 trial was accelerating…

“It had already completed testing on several of the new participants.

“And results are expected soon.

“That’s a huge catalyst.”

The ad sums up:

“A $150 million market cap company with a real chance to make billions in annual revenue?

“I’ll take that bet any day.

“If they achieve even a fraction of the success Humira has, it could mean a 10x increase in this tiny company’s stock – easy.

“But we all know the best time to get into any stock – especially early-stage medicine – is right before the company releases positive news…”

Well, that depends on how much “positive” is expected… but yes, if you know the news will be good and nobody else knows that, you’re in a lovely spot buying the stock.

And he goes deeper into the Humira comparison:

“Humira laid out the blueprint for a drug like this.

“It is – by far – the #1 drug in the world…

“And it got that way by treating some of the world’s most debilitating and deadliest diseases.

“Humira was first approved and gained massive success for treating rheumatoid arthritis (RA).

“In a preclinical study in April, conducted by a third-party lab, this new one-a-day pill was shown to inhibit RA inflammation 70% better than Humira.

“And remember, this one-a-day pill could not just treat the symptoms of these diseases… but cure them.”

OK, so that means this one is starting to sound VERY familiar. Just to highlight one word in there that you might have overlooked, “preclinical” means “in the lab” — it means they tested it on a model (like a genetically engineered mouse) or a sample, not on a human being.

A little more hype to close it out…

“This one-a-day pill could realistically replace Humira as the #1 drug in the entire world.

“The precedent has already been set.

“Humira went from zero to $20 billion in sales a year doing less than what this one-a-day pill promises to do…

“And you can get in now for a few dollars a share.”

And Curzio also spitballs a bit about takeover potential, particularly noting that because Humira goes off-patent next year, perhaps AbbVie will want to buy up a next-generation TNF-a inhibitor. I would assume there’s no rush, but they’ve certainly got the money if they want to take that path (ABBV is still gushing with cash from Humira, even though expectations are that the gusher will slow over time as the patent(s) expire — they currently pay out about $2.5 billion in dividends each quarter, so that gives some indication of the scale they’re working at — a little $150 million outfit would be an easy swallow if both parties were interested).

So hoodat? Thinkolator sez Curzio is following the same path trod by Roy Blanco a few months ago, recommending little MyMD Pharmaceuticals (MYMD).

Though that might be unfair, Curzio has probably owned this stock for a while — he was presumably a participant in one of their private placements a couple years ago, since he popped up as one of the investors when MYMD registered those new shares last year, though I don’t know if he owns it currently. He also has talked about this same stock freely and publicly in the past, including a brief plug on Charles Payne’s show on Fox Business last month…

The stock is a lot cheaper than it was when Frank shared those particular comments (which was about the same time that Blanco was touting the stock, following some early-stage good news), the share price for MYMD has fallen by another 40-50% in the past month. That doesn’t appear to be because of any shift in thinking about the drug — it’s probably a combination of another private placement offering going through at the end of August, since investors never like dilution, and just some market weakness that’s making investors pull back on long-term speculations like early-stage biotech stocks.

I wouldn’t overthink the dilution bit, there’s nothing to really dilute yet and it will take at least hundreds of millions of dollars to develop this drug if it’s going to get approved and become a real player, so the positive outcome would be MYMD getting more investments and/or some strong partners for future development. There is always risk that a small cap biotech company just burns through its money for years, raising more and more money at lower and lower valuations from true believers before ultimately giving up the ghost, but you can’t really place early stage bets without taking that risk. Little companies either give up a lot of control by partnering with a big player, or they have to raise money consistently to get them through the long and expensive process of developing a drug and getting it approved by the FDA.

So that’s partly why these little stocks are so news-driven — they don’t have any revenue or any financials that mean anything, other than their cash burn rate. If you rely on raising money every year or two to keep the R&D process moving, then you need to have good news coming out of the clinical trials to interest those new investors you’re recruiting.

I’d agree that MyMD is indeed a small and interesting company, though it’s also going to need a lot more financing after this clinical trial, and is therefore relying a lot on the initial Phase 2 results of their lead drug, MYMD-1. That drug is indeed a TNF-alpha inhibitor, and it is a pill instead of an injection, which makes it more convenient, but it also, they hope, has the potential to have a similar impact to Humira and other TNF-alpha blockers, with side effects that seem so far to be less frightening. Here’s how MyMD describes the drug:

“MyMD’s lead clinical candidate, MYMD-1®, is an orally available next-generation TNF-alpha inhibitor with the potential to transform the way that TNF-alpha based diseases are treated. MYMD-1®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-alpha inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. MYMD-1 has demonstrated the potential to slow the aging process and extend healthy lifespan. The company is evaluating MYMD-1® in Phase 2 studies for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications.”

That’s not going to provide any relief for those who suffer from Crohn’s Disease or Rheumatoid Arthritis anytime soon, sadly, this is still early days — but in the future? I guess the only answer we can give is, “maybe.” This Phase 2 trial could help to confirm that MYMD-1 is safe, and that it can lower TNF-alpha levels in the blood in older patients who are suffering from sarcopenia (often just called “frailty”) and chronic inflammation, and if it does look good after that data comes out, MYMD will probably get a boost and be able to raise more money to fund the next phases of their clinical testing for the drug in sarcopenia and other inflammatory conditions.

They’re currently positioning themselves to offer an “anti-aging” treatment, partly because inflammation exacerbates many of the diseases of aging, but in the future, sure, maybe they’ll be able to work to position themselves as a Humira alternative.

We’re a LONG way from any kind of efficacy data when it comes to the real impact of the drug, but in the few folks who have taken it so far the company press releases indicate that they’re seeing no worrisome response, and have been able to step up their dosing to higher levels… and it’s true that they do expect the first real efficacy results in this sarcopenia study by the end of the year (“in the fourth quarter” is what they’re saying now, pushed back a bit from the previous promise of “in the second half of the year”), though investors might want to see something more dramatic than the same “it lowers TNF-a in the blood” result that they reported after Phase 1 (that’s the primary measure they’ve agreed to for the FDA reporting), so any other comments about the drug’s impact on individual patients might be watched closely.

As with many investigational new drug programs, they have had their fair share of delays in getting clinical trials enrolled and moving, partly because of the friction that COVID-19 added to the health care system, but apparently they’re moving pretty well right now. Sometime before the end of the year, they’ll be telling us more… and I would guess, given the results so far, that the “more” will be at least relatively positive, though the share price right now is telling us that investors are not so inclined to get excited about early-stage results at the moment. Will that change in the next few months? Well, I’ll be watching to see, just like you. If I were buying this one (I’m not), I wouldn’t try to trade the ups and downs of clinical updates — that’s just betting on a horse race where you know the other betters are way more familiar with the horses than you are. I’d put it in the “high risk, high reward” pile, be ready to face a 100% loss if it doesn’t work out, and take a small position that I could ignore for a few years while they work their way through the clinic.

Have a bet to place on MYMD as the “next Humira?” Think it’s too risky, or see other problems with the drug? I’m no expert on biotech, for sure, so I’ll leave it to you to make your own call — please let us know what you’re thinking with a comment below.