Happy New Year!!!

Investing in micro-cap stocks with a 3-5 year time horizon, which is my expectation for a holding period every time I enter a position, will by definition result in lots of volatility. That was certainly the case in 2021, where my portfolio rode out the market’s internal machinations like a cowboy rides a bucking bronco.

In mid-February I was sitting on a 30% gain for the year. By April it was a 6 percent loss, only to hit net returns of 20% in August. Then healthcare stocks collapsed and the TW portfolio took it on the chin to close down 9% for the year. Frankly, after 2020’s net gains of 72%, it’s not surprising to give back a chunk. But, the process was really painful to watch on a daily basis.

A lot has been written about how the market’s performance is concentrated in just a few names, so I won’t spend a lot of time on that. However, this one tweet sums up how stocks were acting going into 2022.

It also provides a good warning for investors who continue to bid up the biggest winners of the last few years. History should always be our guide and caution is certainly warranted at this time.

Back to TW’s universe, here’s another interesting fact. Every non-healthcare stock I cover was up in 2021…and every healthcare stock was down. Here’s how 2021 looked for each stock.

My overweight in healthcare was directly responsible for the negative performance in 2021. Looking forward, I’m happy to be owning a lot of healthcare stocks as the group’s underperformance has reached record levels. Eventually that reverses…most likely this coming year.

My individual stock selections in healthcare all shared a common theme. They executed fundamentally, but covid-related issues slowed down progress across the board. It’s clear that the large companies with deep pockets were well positioned to move quickly and capitalize on the pandemic. Meanwhile, smaller companies in general, lacked resources and seemed to be swimming upstream. I’m very happy with the underlying programs’ performance for these companies, but spent last year wishing milestones stop getting pushed backwards.

Entering 2022, my investments are poised for a big year. Valuations have collapsed, with some stocks like Lantern and enVVeno trading near or below cash value. Meanwhile, important catalysts that just couldn’t get over the finish line in 2021 are stacked up in front of us; if TFF Pharma doesn’t get a deal with a major pharma partner over the finish line early in 2022, I’ll be beyond shocked.

So, I turn the calendar to the new year with a combination of trepidation about the market and the global-macro environment, offset by excitement about the companies in which I’m invested. Taking a long-term focus leads to volatility but knowing what you own provides the comfort to ride out the storms.

While I don’t know what the market will bring in the new year, I do know a lot of good things are lined up for my companies. So, here’s a rundown alphabetically on the TW universe, with a preview for what each company can expect in 2022.

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Amryt (AMYT): asymmetrical risk makes Amryt a solid pick heading into 2022.

When investing in a biotech, one must always assume that the FDA could derail a clinical program. This happened recently for Amryt as their EB drug’s PDUFA date got extended with the FDA requesting additional data. Normally this is disaster but, for AMYT, it was more like, “meh.”

The muted reaction to the EB drug’s delay is the direct result of Amryt being a value play with growth potential. The company currently has three drugs in the market and trades at a very reasonable multiple of under 3x 2022 revenues. This with growth looking to be north of 25% in the next year, makes Amryt a very cheap stock.

That value should start to be realized for investors in 2022. Shares of AMYT were weak post their acquisition of Chiasma this past summer as the Chiasma investors moved on. That is now behind us and the product they acquired, MYCAPSSA, is now being marketed by Amryt’s team. This is a natural fit for them and I expect sales to surprise on the upside over the course of the year.

The strength of the products alone should be enough to drive AMYT higher. However, we now have the new PDUFA date on the EB product in Q1. Hopes are not high here, yet that creates a nice asymmetrical opportunity. I think AMYT is going higher in 2022 based on their three currently approved products. Success with the FDA and we could have a gangbuster year.

Anixa (ANIX): success in either (or both!) of their two potential blockbuster trials could make 2022 a big year for Anixa.

The strength of Anixa’s business model is also its curse. By partnering with world-class research facilities like Moffitt and Cleveland Clinic, Anixa has access to talent and programs that far exceed what they could afford to have in-house. Their partners share a lot of the financial burden of these programs and can add value in many ways.

At the same time, Anixa is always at the whim of their partners when it comes to timing of events. Programs are driven by the partners and their PI’s, making Anixa subject to delays beyond their control. This is an unusual arrangement for a public biotech company and the double whammy here is Anixa’s share price has suffered from this approach; institutions just haven’t seen it before.

But, data drives cures all in biotech and 2022 is the year that Anixa finally sees clinical results from their programs.

Starting with the vaccine program, dosing has already begun and I expect we should receive an update on enrollment very soon. Cleveland Clinic controls the data release and has decided to get a meaningful number of patients’ biomarker results before sharing this, so expect to see data sometime around the end of Q2.

Similarly with CAR-T, Moffitt Cancer Center should be dosing ovarian cancer patients sometime in the next few weeks and is looking for a Q3 readout to the markets on the efficacy of the program.

So, the wait goes on for a while longer with Anixa. They are now in patients in one trial and close to dosing in a second. Their partners are world-class and enrollment is happening with results to follow. This is the big year for Anixa as either program showing success will likely be worth multiples of the current $90 million market cap. The summer could be very exciting.

Atomera (ATOM): is this the year we have been waiting for?

I have to admit, I’m tempted to take last year’s preview and cut and paste it into here, changing 2021 to 2022. For, while it seems that Atomera continues to make excellent technological headway, the customer traction remains elusive; well, at least from the public’s view. Under the surface, things are percolating nicely.

Which means that 2022 should likely be the year for Atomera to finally get MST over the goal line and into some definitive product wins.

This belief I have is rooted in the very positive data that demonstrates the benefits of MST. Game-changing technologies don’t come around often and, by all measures, MST qualifies as a potential game-changer for a very large swath of the massive semiconductor industry.

When will this happen? Your guess is as good as mine. However, you will want to be invested in ATOM the day the announcement comes and that’s why it’s my FOMO stock and one that I continue to hold with high confidence. Will 2022 be the year? Every day we are one day closer…

enVVeno (NVNO): clinical results will drive this stock out of the bargain basement and into the hands of a larger competitor; timing is the only question.

What do you get when you have a breakthrough device going after a potentially massive end market? In the case of enVVeno, an incredibly disappointing stock. For, despite excellent results from their first-in-man trial, and despite a medical community that sees the value of this product and has given them substantial recognition, this company is trading at only a slight premium to net cash on the books. Crazy.

enVVeno (okay, let me just say that I really don’t like this new name for the company) has a market cap of $60 million dollars. The end market they are going after, chronic vascular insufficiency, has (by various estimates) somewhere between 400,000 and 800,000 new cases per annum. At $10,000 a device, which is a conservative estimate, this is clearly a multi-billion dollar market. With exactly zero approved competitors.

Typically, medical devices like the VenoValve, will be acquired by larger companies once they return clinical data from a pivotal trial. That trial was started by NVNO in September of 2021. It’s my belief that this product will be worth several hundred million in an acquisition if the trial is only close to being as successful as their first-in-man was. This belief is likely shared by Perceptive Funds, maybe the best HC hedge fund out there, who invested $20 million in common stock of NVNO last summer.

The big question for investors is when we will see the results. There’s a good chance we get a peek at them, through an interim analysis, in 2022. We might also not see them until 2023 when the trial has been completed. I believe that NVNO will start to move up from its deep value over the course of the coming year. And, when we finally get the data, things should get very interesting.

Fortress Bio (FBIO): lumpy cash flow and major catalysts in portfolio companies will add to the underlying value of this sum-of-the parts stock.

With holdings in 4 public entities spun off from the parent company, FBIO is a unique sum of the parts story. Typically, these types of stocks get undervalued by the market as investors want more of a pure-play. That’s been the case here, which sets Fortress up as a great value play heading into a catalyst filled year.

Fortress currently has about 40 programs underway, all at various stages of development. That means lots of potential events throughout 2022, but only a handful of these have the potential to drive a revaluation of FBIO stock. Let’s look at those.

• Checkpoint Therapeutics (CKPT) should be announcing data from their pivotal trial of Cosibelimab sometime in early January. This drug has blockbuster potential and could drive significant value to FBIO shareholders through their ~30% ownership of CKPT.
• Cyprium is set to complete their rolling NDA submission on CUTX-101 around the end of Q2. This program, if approved by the FDA, is under agreement to be sold off, resulting in an $8M payout to FBIO. More importantly, it also qualifies for a PRV (priority Review Voucher) worth roughly $100 million, 75% of which goes to Fortress.
• Mustang Bio should be starting two pivotal trials in Q1. These programs all have large upside and have been overlooked by the market.

In 2021, Fortress sold Caelum to AstraZeneca, which resulted in a $60 million cash payment to the company with more to follow on milestones. Somehow the street managed to not react to this news. This year, if the catalysts hit, the sum of the parts will force investors to consider FBIO and further validate this unique business model which is creating fantastic returns to the parent company.

INmune Bio (INMB): with two compelling programs knocking the cover off the ball, INmune is poised for success.

After INmune reported results in their phase 1 Alzheimer’s study last summer, the stock sold off, losing 2/3rds of its value. This is not because the study wasn’t successful; quite the opposite, the results were better than anyone could have wished for. Instead, the reason INMB traded down (besides the weak overall market for small cap biotech) was concern from investors that we are now 2+ years from the next major catalyst. This couldn’t be further from the truth.

True, investors likely won’t see results from the phase 2 trial in AD until sometime near the end of 2023 at best. But, there is some much more going on at INmune than simply the Alzheimer’s program; which could be massive by the way. Indeed, 2022 could end up being a blockbuster year for INmune on multiple fronts while the AD program chugs along, dosing patients in the background.

First off, the INKmune program is just ramping up. They have dosed three patients so far, two under compassionate use and only one in the trial. Thus, there’s not a ton of data but the results we have seen have been wonderful. Strong enough to drive the enrollment of compassionate use cases and likely to also lead to more rapid enrollment in the ongoing trial.

Going forward, I expect to see several more patients dosed in the first trial here in Q1. Results from these patients will be coming on a regular basis as they enroll. If the results come close to those seen on the first patient, the market should start waking up to the potential of this program.

We will also be getting more information on the two patients dosed under compassionate use. These were both patients who, tragically, were not expected to survive much longer with cancer ravaging their bodies. Any positive results from INKmune in a late-stage patient would be phenomenal.

Finally, near the end of Q2, we should see the start of the ovarian cancer trial. Similar to MLS, data will be coming from patients on a regular basis. If the MLS trial continues to put out excellent data, enrollment in the ovarian trial should be more rapid. The bottom line on INKmune is that we could see enough data in 2022 for the drug to clearly demonstrate blockbuster potential.

Besides INKmune, later in the year we could possibly get results from the recently announced MCI (mild cognitive impairment) trial of XPro-1595. While not as exciting as Alzheimer’s data, MCI is closely related and success in this trial will likely cause expectations of the AD program to heat up again. This has driven the stock before. The next time it will likely achieve new heights.

I have been a very vocal supporter of INmune. In my experience, I’ve never seen two programs with such great early data and such open-ended potential. At roughly $200 million in market cap, the opportunity for a 10-50X return exists over the next couple years. Companies with less exciting, but more advanced programs, trade for many billions of dollars. Could INmune be there soon? I believe so and 2022 will be a time where the data given to the market can help us judge the likelihood of their eventual success.

Lantern (LTRN): in the aftermath of the micro-cap biotech selloff, Lantern represents a compelling opportunity.

With an $80 million market cap, LTRN is trading right near its cash value per share. The burn rate is low enough that they have nearly five years cash on the books; enough cash to afford a stock buyback program which is ongoing right now.

For that $80 million, investors get two interesting shots on goal. There’s the traditional pharmaceutical development side of Lantern and then there’s the Artificial Intelligence driven drug development engine called RADR.

In terms of drugs, Lantern has several exciting catalysts for their programs coming in 2022. LP-184, a drug with blockbuster potential, will be undergoing IND enabling studies in the first half. This is in anticipation of an IND filing sometime in Q2 for the indications of pancreatic cancer and glioblastoma (GBM).

Their drug for never-smokers who get lung cancer, LP-300, will start enrolling in the pivotal HARMONIC trial in early 2022. Not many companies have a drug at this phase of development while trading at cash value…

Meanwhile, as they approach 13.5 billion data points, RADR continues to become one of the leading AI engines for drug development. It has proven itself effective in their internal programs. Now, in 2022, I expect to see Lantern make use of RADR through partnerships with other drug companies and also through discovery of drug combo opportunities.

It is this two-pronged approach that gives Lantern a unique opportunity in the market. An opportunity that has been hit hard through a combination of a weak biotech sector and lack of marquee investors in the name. At this valuation, however, and with lots of catalysts coming, I expect to see the tide turn for Lantern in 2022.

Movano (MOVE): Movano is one of my newest recommendations and a very timely investment looking at 2022.

Having gone public in 2021 and suffering in the market, like many other IPOs from this past year, MOVE enters 2022 in an oversold condition. It also is a completely off the radar screen stock with exactly zero (0!) Wall Street analysts publishing research on the Company. In fact, they have been operating in what appears to be stealth mode, which is certainly not the norm for a public company. That is set to change in 2022.

This past week, Movano announced that they will be unveiling their first product, a health-monitoring ring targeted at women, at CES 2022, which takes place in early January. The product itself is very interesting in that they have demonstrated an ability to get their form factor down to a size best described as miniscule. This, of course, means the Company can place their technology in multiple form factors; a very important step as the eventual plans for Movano likely include partnering their technology with other companies.

In a space that has some big players, like Apple, Fitbit, etc., what makes Movano special. It is their intention to get into blood sugar and glucose monitoring. This would be the Holy Grail for non-invasive, wearable healthcare monitoring technology. If they can be first to market here, Katy bar the doors.

Where do they stand in this? Movano recently announced that they had finished taping out their microchip, which is now with Global Foundries for fabrication and testing. This is anticipated to be done at the end of the spring. Meanwhile, clinical evaluation of their unique RF technology is ongoing. This year looks to be the year where we learn how well the technology works and if they have developed a successful single-chip solution capable of being worn by users and delivering quality, dependable health data.

I’m optimistic that with the team they have in place, which includes CEO John Mastrototaro, a proven exec with history at device manufacturers Medtronics and Stryker, Movano has the right people to pull this off. The Company also has deep pocketed backers and raised a lot of money through the IPO process. They have the runway to see themselves through to success. The bet here is that the technology works; we are going to find that out in 2022 and, if it does, this will be a great stock to own.

ParkerVision (PRKR): as we exit 2021, is it possible that all the stars are finally lined up for ParkerVision?

If you want to use a baseball analogy, it could be said that PRKR is entering the 9th inning of their contest against Qualcomm. That just doesn’t do this epic struggle justice. Instead, compare this war it to a cricket test match…if your typical patent lawsuit takes 9 innings and three hours, this is India versus Pakistan and they have been going at it for days on end. Now, as we enter 2022, the finish line is finally in sight.

Looking back at the past year, it has been one of frustration on one hand. What with Covid delaying court cases, the expectation for a final trial date in their Florida case has been continually pushed back. This seems interminable.

On the other hand, 2021 saw many smaller skirmishes that were consistently won by ParkerVision. These smaller victories portend a likely positive outcome in the overall battle.

To wit, the following accomplishments from the past year give me hope that 2022 will be when the chickens finally come home to roost.

• Parker has had several settlements in smaller lawsuits with electronics manufacturers. These settlements include ongoing royalties and demonstrate the solidity of PRKR’s patents.
• The Intel lawsuit (now lawsuits with an “s”) will take place in 2022. Parker had a resounding victory in the Markman rulings in these cases. The winner of a Markman is victorious in court roughly 90% of the time!!!
• More law firms have joined the Parker team. These groups are working on contingency; they only get paid if Parker wins. This speaks to the overwhelming evidence found in discovery.
• Speaking of evidence, internal Qualcomm emails seem to acknowledge the strength of ParkerVision’s patents. Ouch…
• Finally, the trend in patent lawsuits has firmly moved in favor of the patent holder and away from big tech; witness Intel’s and Apple’s large losses this past year.

Looking out the next twelve months, I’m very optimistic that we will see three things. First off, expect more settlements in small to medium sized suits. These will fully fund ParkerVision for the big trials.

Secondly, I expect we will see a court date finally decided in the Qualcomm trial. Hopefully, this will take place here in Q1. Once we know the date, the stock will likely move higher in anticipation.

Finally, we will have our day in court. A victory by ParkerVision over Qualcomm will likely be worth anywhere $5 to $10 per share. It will also be a huge red flag for Intel, who could possibly decide to settle rather than fight what, at that time, would appear to be an inevitable loss. That would add another few points to PRKR stock.

Our court system can be frustrating, expensive and slow. But, like a glacier, it does move and inevitably everyone has their day in court. 2022 will hopefully see ParkerVision get their long overdue moment in front of the jury. I believe it will have been worth the wait.

Quest Resource Holding (QRHC): my top returning stock in 2021 is likely to be a strong performer again in 2022.

Looking at TW’s universe of stocks, Quest is an outlier. It’s not in a growth industry and has no big catalysts that are going to skyrocket the stock. Instead, this is a story of fundamental value and execution, and Quest is telling a great story right now.

Recall, that Quest was a turnaround story when I got involved two years back. The company was hemorrhaging cash and fighting a losing battle against the larger incumbent waste companies like Waste Management.

Enter a new key investor who funded the company and brought in new management along with a new direction for the company. Under Ray Hatch, Quest cut a number of losing contracts, reducing sales but increasing gross profits. They downsized into a profitable entity while redirecting the Company into an ESG compliance partner for producers of difficult to handle waste streams.

Now, instead of competing with the big boys, Quest has firmly moved into a smaller niche of the market with no dominant competition. And, this niche is a wonderful place to operate as it is growing faster and generating higher margins than the larger garbage hauling buisiness.

As we enter 2022, look for Quest to continue rapid growth in three different ways. There is organic growth as their ESG compliant recycling services gain more customers who are seeking alternatives to simply filling garbage dumps with their refuse.

Then there are the additional services that Quest can offer existing customers. Due to acquisitions, Quest has expanded their product offering which they can roll out to their current clients. At the same time, the 50% increase in business they recently acquired through acquisitions offers great growth opportunities in terms of geographic expansion and additional product revenue streams.

Finally, CEO Hatch has proven very effective at finding and integrating accretive acquisitions. Expect more of this in 2022.

Add it all up and Quest is likely to continue growing rapidly. As they reach critical mass and generate consistent profitability, their EBITDA multiple should expand. And, that’s the icing on the cake for 2022. Between solid execution, great growth and multiple expansion, this next year will likely reward investors with another year of solid market beating returns.

Spectra7 (SPVNF): rapid growth in their datacenter business will drive Spectra7 higher in 2022.

Although they are coming off a small base, check out the revenue growth of SPVNF in 2021. Q2 50% growth over Q1. Q3 100% growth over Q2. Guidance for Q4, 100% growth over Q3. Explosive, to say the least.

Looking towards 2022, expect to see more explosive growth from Spectra7. This growth is due to their positioning as the leader in active copper cables, a growing segment of the next generation of datacenter build-outs taking place.

While not providing exact guidance, management has indicated that revenue will grow multiples over 2021 next year. This makes sense as the company has only just started shipping into 6 of their design wins; they have about 80-90 more that should start shipping over the next 2-3 years.

Spectra7 is a simple story. They have designed a leading product in a growth industry and have a 2-3 year lead on competition. They are winning every RFP and their are about 50-60 new datacenter RFPs per annum. This is the sweet spot for SPVNF and the only thing slowing them down right now is supply chain issues. They can sell everything they can make for the foreseeable future.

With this kind of growth, the stock should start attaining a better multiple. This will only increase with a US listing, which is being targeted in 2022. I expect to see Spectra7 put up at least $25 million in revenue in the next year and trade at a minimum of 4x that number; likely higher. Trading today at roughly 2X next year’s revenue estimate, the stock is a bargain and poised for a big year.

TFF Pharma (TFFP): to quote Maverick from Top Gun, “This is what I call a target rich environment.”

Like so many companies in the micro-cap healthcare space, 2021 was not a good year for TFFP. The stock was hit continually throughout the first 9 months of the year, losing around 50% at its low point. Not all of this pain was market related, too. The stock suffered from other factors, primarily that there was substantial insider selling early in the year. These sales were unrelated to the fundamentals of the business, but the damage was done.

However, stocks are nothing if not forward looking and TFFP was the best performing healthcare stock in my universe during the 4th quarter, a time when most healthcare stocks took a drubbing. This strength is due to the many, many shots on goal that TFF has coming over the next year. Shots that increasingly are looking to be on target.

What exactly does 2022 have in store for TFF? I’ll start by bullet pointing the internal programs as there are quite few catalysts coming.

• Both Voriconazole and Tacrolimus will dose their first phase 2 patients in the coming weeks. There will be an interim analysis of the data from both programs in the summer. Positive data for VORI and TAC will enable them to partner these drugs off for sums that likely start with upfront payments in the 10’s of millions and total compensation in the hundreds of millions…plus back end royalties to boot. TFF has stated they will start conversations with partners in the coming months, in anticipation of the positive results. Updates on this process could drive substantial value here.
• The ongoing phase 1 for Niclosamide should wrap up early in Q1. If this data is positive, and the preliminary data indicates that’s quite likely, expect UNION to pick up their option on this program. That would result in a cash payment to TFF of around $10M, plus other payments in the hundreds of millions from milestones and royalties.
• TFF’s 50-50 partnership with Augmenta will start their phase 1 trial in Q1. This drug, if it’s approved, would be the first inhaled monoclonal antibody, a significant milestone with implications beyond just this one program. Expect to see this drug partnered off later in the year if the data justifies it. Again, a partnership on this drug would be worth hundreds of millions to TFF over time.

Beyond those in-house developments, there are many other potentially significant catalysts out there for TFF. Start with Pfizer, who is now collaborating with TFF on at least one drug. This relationship has been undercover for quite a while now but has finally moved to the point where Pfizer is allowing TFF to use their name when speaking with investors. That positive sign could turn into a signed license agreement sometime in the next few months, if TFF’s technology meets Pfizer’s expectations.

There’s also the approximately 10 additional term sheets on Glenn’s desk that are in various stages of development. With MTAs (Material Transfer Agreements) in place with more than 1/2 the top 20 pharma companies globally, it’s not a stretch to think that any one of these term sheets leading to a signed deal would be quite meaningful to TFF.

Then you have the collaboration with Dr. Drew Weissman, the inventor of the mRNA vaccine technology being used by Pfizer and Moderna. Dr. Weissman has four projects ongoing with TFF and is a big proponent of the technology, sitting on their Scientific Advisory Board. The markets have seemed to yawn at his involvement, but he is directly responsible for the many billions of market cap enjoyed by Pfizer and Moderna.

I could continue on with many other lesser, but important, potential catalysts. The US Army, the many academic collaborations, Greenlight, Felix Bio, etc. The list is extensive. But, the great thing about investing in TFF now is you get all those potential catalysts at a very, very reasonable price.

The lack of a signature transaction, two of which had been the goal of management, has caused shares of TFFP to trade down sharply in 2021 despite significant progress being made on their programs; remember that TFF has never lost a bakeoff on their technology. Now, as we enter 2022, I am expecting to see the rubber finally hitting the road.When it does, there’s a lot of clear sailing ahead for TFF’s stock.

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I’d like to say a big thank you to the TW universe for all your support in 2021. As the Chinese curse says, “may you live in interesting times.” The last couple years have been too interesting. I’m hopeful that 2022 might bring a semblance of normality back to the world and wish you all a wonder New Year filled with health, happiness and success in the markets!

TW Research's Disclaimers & Disclosures: TW Research may have been compensated for writing this article. For a full list of disclaimers and disclosures, please visit http://tailwindsresearch.com/disclaimer/.