Resetting Expectations for TFF Pharma

Thin Film Freezing, the drug delivery method being developed by TFF Pharma (TFFP), is an exciting technology that has the potential to change the method of delivery for a significant portion of the therapeutics currently in existing as well as many new drugs being developed. By delivering drugs directly to the lungs, as opposed to injection or swallowing into the GI system, thin film freezing can deliver efficacious quantities of drugs at lower dosage, not only lowering the cost but simultaneously reducing the side effects of many medications. It truly is a platform with almost unlimited potential.

But, as they say, Rome wasn’t built in a day. Drug development takes time and introducing a new technology to potential partners isn’t an overnight process. Since peaking over $20 earlier this year, shares of TFFP have had a rough ride, recently trading under $10 per share.

The primary reason for the selloff in TFF is the lack of a marquee deal with the lead covid vaccine manufacturers. Many investors, myself included, had hoped to see a partnership announced here. Management had also expressed this hope which added to the expectations here. Alas, while there still exists a strong potential for a CV-19 deal with Pfizer or Moderna, the company’s inability to land one so far has led to disappointed investors.

It has also led an outstanding buying opportunity. For, while traders have moved on to other, more immediate, plays, the future for TFFP has never looked brighter. While the stock has drifted down, the Company continues to execute on its numerous programs in development and prospects for thin film freezing taking substantial share in several major markets just grows stronger.

At TW Research, we had made TFFP a very large position at $5ish per share last year as we got excited about the opportunity for the broad adoption of the platform. Once the stock ploughed through $10, I thought it would never hit see levels again. But the market is a pendulum that swings quite broadly these days and here we are again. And, like when TFFP was languishing at $5 a year ago, we are looking at a great opportunity to pick up shares before the next move.

Look Beyond Covid…Many Programs Are Percolating

After the last quarterly update by management, shares of TFF rebounded nicely. This was due to the breadth of the programs under way as well as the excitement demonstrated by management in the opportunity in front of the Company. The conference call replay is highly suggested homework for TFF investors.

TFF has a lot of programs underway. Here I’ll lay out the programs along with comments from management. As they said on the call which is now several weeks past, “It’s only been two months since our last earnings call and in just that short period of time, we’ve made significant progress on all fronts.”

Voriconazole:

• Our Voriconazole Inhalation Powder product development is proceeding well on plan to support the upcoming clinical development program.
• we are on track to begin our pivotal clinical trials
• The data generated in our Voriconazole program to date has significantly removed risk from the program…we can safely administer a dose more than twice the dose of inhaled Voriconazole that is currently being used

Tacrolimus:

• the development activities are proceeding well…enrollment will be completed this month in our Phase 1 clinical trial
• we have filed a U.S. patent application based on the ability to reach efficacious blood levels from once-daily dosing
• The enhanced bioavailability and ability to bypass the gastrointestinal tract could also open the door for treatment of other solid organ transplants where significant drug-drug interactions and food effects are observed with oral Tacrolimus.

UNION and Augmenta Partnerships:

• In the next few months, we’ll be generating important data that will move these programs towards human clinical trials that will begin in the second half of the year.

mRNA platform:

• We have a large number of active mRNA programs under way. And this number of projects continues to grow. As we continue to elevate our expertise in understanding and formulating, different LNPs and mRNA generating data and delineating a clear distinction of our technology versus other technologies, pharma partners are now knocking on TFF’s door, looking to engage with us.

NeuroRx Partnership:

• The feasibility arrangement with NeuroRx is progressing. TFF has successfully formulated NeuroRx’s peptide for treating COVID in an inhalable, dry powder optimization work and stability testing of the dry powder is underway.

Greenlight Bio:

• We are planning to perform our formulation testing over the next few weeks.

Felix Bio Partnership:

• Felix Bio continues to enroll CF patients for their investigator-initiated study. Upon successful results, Felix will be seeking to raise capital and we plan to execute on our LOI and finalize a definitive agreement.

USAMRIID Partnership:

• Our TFF dry powder was successful in vitro testing for both the monoclonal antibody program and the VSV program. We are now planning in vivo testing, and if successful TFF would seek non-dilutive funding to move both the vaccine programs forward into development.

It’s overwhelming, right? And this is only the tip of the iceberg. As they said on the call, in addition to the above, “we are currently formulating our partners’ proprietary siRNA, plasmid DNA, oligonucleotides, phage, peptides, monoclonal antibodies, cytokines, AAV, VLP, and VSV product candidates, along with many other different proteins and small molecules.”

The Rule of Pi

One issue created by Operation Warp Speed is this expectation that drug development happens immediately. Pfizer, JNJ and Moderna all did a tremendous job creating vaccines in record time. However, that was the phase 1 programs. Now, as life returns to normal drug development will do the same.

Sri’s Law (aka The Rule of Pi) says that you should take every timeline given by management and multiply it by Pi. It’s surprisingly accurate.

I believe that in the hype of the vaccine development, especially since TFF’s tech is so very applicable here, both management and investors got over the skis. The thinking that TFF would be in human testing, for a CV-19 vaccine, by June was, in hindsight, flawed.

This doesn’t mean that TFF won’t be in a phase 2 vaccine. Nor does it mean that the other programs aren’t moving forward. It simply means the stock got ahead of itself.

TFFP has now reversed track and is well below where it should be trading. The catalysts are lining up, the programs are numerous and progressing. And, they are marquee in nature; as CEO Glenn Mattes said, “I still stick to what we said at the beginning of the year, two deals, at least two deals by the end of the year.”

Drug development takes time and platform technologies don’t get adopted overnight. But, TFF is well positioned and making progress. One final Glenn quote sums it up well, “We win every time. I’ll stop there. Every time we’re put up in a bake-off or a beauty contest, we win.”

All signs continue to point towards inflammation being a major bugaboo in many diseases. This is particularly true in treating covid and the symptoms of long-covid.

All reading I do suggests that INmune (INMB) is on the right path to being a part of the solution here. Here’s an article that discusses the effects of covid on people already taking TNF inhibitors for RA. The key line from this report, “The use of a tumor necrosis factor (TNF) inhibitor was associated with a lower risk of hospitalization“.

That last line screams Quellor!!!

There’s also long-covid and the symptoms of this terrible disease all point toward it being neurological, similar to Alzheimer’s and depression, two target areas for XPro1595. This disease is on a path towards becoming a much bigger deal than most people realize. The approach of the end of the pandemic doesn’t mean the end of health issues around CV-19. The following comes from a good Time Magazine piece on long-covid.

“A University of Washington study published in February in the Journal of the American Medical Association’s Network Open found that 27% of COVID-19 survivors ages 18-39 had persistent symptoms three to nine months after testing negative for the viral disease. The percentage was slightly higher for middle-aged patients, and 43% for patients 65 and over. The most common complaint: persistent fatigue.

“Furthermore, a Mayo Clinic study published this month found that 80% of long-haulers complained of fatigue and nearly half of “brain fog.” Less common symptoms are inflamed heart muscles, lung function abnormalities and acute kidney problems. Symptoms of autonomic dysfunction are showing up in patients who had mild, moderate or severe COVID-19 symptoms.”

As impatient investors, we have waited what seems to be an eternity for results from the Quellor trial. Some people think INmune is now too late to the party there. Sadly, it appears that this dance is going to last longer than expected. Quellor and INmune still have an opportunity to play a big role in helping with the eventual solution.

We recently had a Zoom call with Performant (PFMT). Check out the price action there. The stock is breaking out in a big way.

We have been on board Performant as investors, as our premium subscribers know, for a few weeks now. I’m adding it to the coverage universe this weekend. Expect more on the name in the not too distant future.

Another company we had a call with recently is Ondas (ONDS). They announced an acquisition of a drone company about two weeks ago and had an update call with investors this past week, to go over the acquisition in more detail.

Here are the highlights from the call as recorded by one investor…

• There is a very significant pipeline. Demand exceeds their capacity by wide margin. Good problem to have, though they need to build inventory and hire staff
• Over 15 Fortune 500 companies in the pipeline. They are in testing phase.  1-4 units to make sure it works. Mgmt sees the opportunity as 100s if not 1000s of units for their target customers (large corps to start given capacity constraints)
• TAM over $100 B.  Have slide showing math if place 10,000 units at $50,000 annual ASP that equates to $500 mm in annual revs and represents 0.5% or less of global TAM.
• The returns are enormous.  Over 5 year life of drone, CF margin 72.4%.  Customers sign 5 year contracts. Year one ONDS recoups cost of the drone.  Years 2-5, service and maintenance costs only $6,000 versus $50,000 typical annual contract price. Total 5 year CF from drone $181k on $250k revenues.
• Believe can extend service life of drone beyond 5 years.   Extremely attractive economics for each additional year.
• Only autonomous, fully automated drone beyond line of site approved by the FAA. Huge first mover advantage. Cannot be overstated.
• By eliminating need for human operator on the ground, savings to customers are enormous. Customer spends say $50,000 a year on AR drone.  If had to have human pilot cost would be 11x-26x higher (10-24 hours of daily operations). This cannot be overstated. It changes everything for the end customer. And allows the flood gates to open in terms of the enormous potential TAM.

Drones are certain to grow in use and the market is very early. Ondas appears to have done a good job of positioning themselves in this space.

People have been asking for an update on Atomera (ATOM). Unfortunately, there’s not much to say about a company that is notoriously silent between earnings calls. Unless there’s a partnership announcement, that is.

So, besides my thinking that every day is one day closer to the next JDA, I was intending to talk about the price action in the stock. It is apparent to me that the disgust shown after the last conference call (I, too, was disgusted but overcame this to add a lot of stock) created a wonderful buying opportunity. ATOM is acting great and I love the price action here.

I’m not the only one. As I was preparing to post a chart of Atomera, discussing the positive technical action, I noticed someone had done so on StockTwits. So, thanks MicroCapSpeculator! I have stolen your chart and agree with your thoughts 100%.

As long-time readers know, I’m simply not a believer in the long-term use cases for Bitcoin. I turned more bullish on it as a trade late last year, but have never (and likely will never) bought any. My primary concern being that I just can’t see governments allowing their currencies to lose status that easily.

That said, I understand the ground-breaking aspects of the technology and believe blockchain is a very big deal. In the past I’ve tried, unsuccessfully, to find some blockchain plays. I shoulda just bought Bitcoin, but hindsight is always 20-20.

Next week I’m speaking with Greenbox (GBOX). I’m still trying to get my head around the use case for their token, but am fully aware that tokens are coming and forward looking investors should be looking to play here.

In light of my interest in tokens and stablecoins, please consider this an appeal to readers…if you have anything worthy of sharing on tokens and/or possible investment angles here, please share them with me. daniel@twresearchgroup.com

Travel update; we are on Orcas Island this weekend. Orcas is in the Puget Sound, a couple hours north of Seattle. It’s beautiful here and worth a trip. Heading back to SF no Monday for the first time since fleeing last November.