TFF Pharmaceuticals’ Technology Generates Superior Inhalational Dry Powder Formulations for Pulmonary Drug Delivery
TW's Take: more proof that thin-film-freezing is highly effective as a drug delivery methodology. Monetizing the technology is simply taking too long.
Newly published...
TFF Pharmaceuticals Partners with Emory University and BARDA to Develop a Dry Powder Inhaled...
TW's Take: BARDA is a great endorsement for the technology. TFFP's balance sheet issues notwithstanding, the value here for the tech is insane.
Partnership funded...
TFF Pharmaceuticals Announces Positive Preclinical Data from Bivalent Universal Influenza Vaccine Candidates Manufactured by...
TW's Take: more proof of the power of the TFF platform. If only funding were in place, the value here is crazy cheap.
TFF-dry powder...
TFF Pharmaceuticals Provides Continued Positive Outcomes from Tacrolimus Inhalation Powder (TFF TAC) Phase 2...
TW's Take: a great update as TFF-TAC continues to demonstrate outstanding efficacy and safety. The drug has an increasingly high likelihood of being a...
TFF Pharmaceuticals Provides Regulatory Update on Tacrolimus Inhalation Powder (TFF TAC) Clinical Program for...
TW's Take: very positive update as they remain on track and on budget for getting their pivotal trial approved and launched later in 2024.
...
TFF Pharma…An Interview With The CEO
Despite turning the company around operationally, shares of TFF Pharma (TFFP) have fallen dramatically since Dr. Harlan Weisman took over the reins as CEO...
TFF Pharmaceuticals and Leidos to Advance Next-Generation Biodefense Countermeasures Under the DARPA PPB Program...
TW's Take: while this won't result in revenue any time soon, it's further proof of the technology. As TAC moves into its pivotal trial,...
TFF Pharmaceuticals and Cleveland Clinic to Advance Multivalent Universal Influenza Vaccine Candidates into Preclinical...
TW's Take: Further proof of the potential for the Thin Film Freezing platform technology. Another shot on goal and this one paid for through...
TFF Pharmaceuticals Provides Update on Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial for...
TW's Take: more outstanding results from TAC as this drug has all the makings of being a best-in-class blockbuster within a couple years. Now,...
TFF Pharmaceuticals Announces Pricing of $4.8 Million Public Offering
TW's Take: Needed capital gives TFF the runway to get through some big milestones including FDA go ahead to launch pivotal trials, which should...
TFF Pharmaceuticals Makes Available Phase 2 Data from Tacrolimus Inhalation Powder (TFF TAC) for...
TW's Take: more compelling evidence supporting TFF TAC. Valuation here remains crazy low. When will partners care?
Data Now Available on Company Website Following...
TFF Pharmaceuticals Announces Additional Positive Data from the Tacrolimus Inhalation Powder (TFF TAC) Phase...
TW's Take: TFF-TAC continues to have the data to support potential blockbuster status. Once the balance sheet issues are resolved, the value here will...
TFF Pharmaceuticals Announces Oral Presentation of Interim Data from the Phase 2 Study of...
TW's Take: further endorsement of the value of TAC. I believe partners will be highly interested in this program going forward as the data...
TFF Pharmaceuticals Announces $1.2 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules
TW's Take: the balance sheet continues to be the biggest risk to TFFP. Once that's squared away, the stock should perform quite well.
FORT WORTH,...
TFF Pharmaceuticals Announces Update on Clinical Programs
TW's Take: very positive announcement in many ways. The data for both drugs is excellent with TAC surpassing even the highest expectations. If VORI...
TFF Pharmaceuticals to Present Data from Phase 2 Trial of Voriconazole Inhalation Powder (TFF...
TW's Take: nice recognition at an industry conference demonstrates how exciting this program is and why partners will be looking at TFF very closely...
TFF Pharmaceuticals Announces Acceptance of Late-Breaking Abstract for Presentation at the 44th Annual International...
TW's Take: showing a mortality benefit would be a key differentiator for TFF's programs. While the data set is still too small for this,...
TFF Pharmaceuticals Announces Positive Initial Data from Ongoing Phase 2 Trials of TFF VORI...
TW's Take: great news as both drugs are exceeding expectations in both efficacy and safety. Number of patients still low but increasing and accelerating...
TFF Pharmaceuticals Announces Reverse Stock Split
TW's Take: very expected move creates a buying opportunity in front of upcoming data releases.
Common Stock Will Begin Trading on a Split-Adjusted Basis on...
TFF Pharmaceuticals Appoints Thomas B. King to Board of Directors
TW's Take: having more quality people joining the board is a good sign heading into important data releases and needed financing. At this price,...
TFF Pharmaceuticals Announces Publication of Data Demonstrating Feasibility of Intranasal Delivery of Monoclonal Antibodies...
TW's Take: the promise of TFF's technology continues to be advanced.
Research shows the Company’s Thin Film Freezing can reformulate broad range of monoclonal...
TFF Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Corporate Update
TW's Take: much needed capital provides a runway through data in Q4. Insider participation in the financing is a positive and it's now time...
TFF Pharmaceuticals Inc. and Uniphar Durbin Ireland Ltd. Announce the Opening of an Expanded...
TW's Take: yet another sign that the product works and is uniquely improved over the currently approved version of the drug.
Voriconazole Inhalation Powder...
TFF Pharmaceuticals Awarded $2.97 Million to Develop Universal Influenza Vaccine
TW's Take: more confirmation of the potential of thin-film-freezing in this excellent endorsement from NIH. We continue to await data from their lead programs...
TFF Pharmaceuticals Enters into CRADA with the National Institute of Environmental Health Sciences to...
TW's Take: nice to see that the technology continues to impress enough to sign a CRADA but we await the real news of phase...
TFF Pharmaceuticals Receives Additional Funding from Leidos to Advance Next-Generation Personalized Protective Biosystems under...
TW's Take: nice to see that this program continues to advance. TFF has been quiet for a while. Expect to see some more news...
TFF Pharmaceuticals Appoints Harlan Weisman, M.D. as Permanent Chief Executive Officer
TW's Take: Looking forward to getting updates on their in-house programs. The stock is very inexpensive but investors need to gain some degree of...
TFF Pharmaceuticals Announces the Appointment of Zamaneh Mikhak, M.D. as Chief Medical Officer
TW's Take: this is a great step, bringing in house the expertise needed to take products through clinical development and commercialization or partnering.
FORT WORTH,...
TFF Pharmaceuticals Announces Leadership Transition
TW's Take: this has been a long time coming with the company's outstanding technology never seeming to get out of the starting gate under...
TFF Pharmaceuticals Prices $10.675 Million Offering of Common Stock and Warrants
TW's Take: removing the financing overhang is great news for investors. The company now has a runway to reach key milestones over the next...
TFF Pharmaceuticals Announces Collaboration with Aptar Pharma to Explore and Develop Intranasal Delivery of...
TW's Take: another early stage partnership that positions TFF well for next-gen vaccines but does little to overcome the concerns around the company's finances....
TFF Pharmaceuticals Announces Program Updates for Voriconazole Inhaled Powder and Tacrolimus Inhaled Powder Clinical...
TW's Take: tough to understate just how disappointing these delays are to investors. Management's guidance on the timing of these programs has been flat-out...
TFF Pharmaceuticals Announces Second Patient Successfully Treated with Voriconazole Inhalation Powder Through Compassionate Use...
TW's Take: positive results that are meaningful to the big picture here but will be ignored in light of the continual delays in this...
TFF Pharmaceuticals Announces Presentation of Data Featuring Applications of Thin Film Freezing Technology at...
TW's Take: the body of data supporting Thin Film Freezing continues to expand. We need to see some partnerships for the share price to...
TFF Pharmaceuticals Announces Presentation of Patient Data with Voriconazole Inhalation Powder (TFF VORI) at...
TW's Take: this is excellent news as it confirms the benefits of thin film freezing in Voriconazole, ie reduced toxicity, better efficacy. As VORI...
Pendulum Swings
Market movements are similar to the arc of a pendulum. They swing way past fair value in one direction only to see the inertia...
Taking the Long View on TFF
This week my group had a Zoom call with TFF Pharma (TFFP). Over the past year TFF has become a very polarizing stock. There...
TFF Pharmaceuticals Expands R&D Operations with New Austin Facility
TW's Take: this quote, "as many of our partnered programs move to clinical evaluation", is what the investment community is looking for. When TFF...
Going Downhill
This past weekend I spent mountain biking in Downieville. Our group gets shuttled up to the top of the mountain and then careen down...
High Degree of Confidence
This week I'm writing my newsletter on Thursday as I'm heading out to California this afternoon. The upcoming weekend will be spent in Downieville,...
June Gloom
In San Diego, this time of year the mornings can bring coastal fog. Referred to as "June Gloom", it usually lingers until late in...
CEO Knows Best
The saying about insider stock transactions goes like this, "there are many reasons for insiders to sell but only one reason for them to...
It’s Still The Early Innings
Two weeks ago this newsletter was titled, "Don't Fight The Fed". That week I discussed why the market was headed lower. The bottom line...
TFF Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Business Update
TW's Take: continued visible progress on their internal programs, and behind the scenes on partnerships, positions TFF for a number of major catalysts over...
TFF Pharmaceuticals Announces Multiple Presentations Highlighting Broad Applicability of its Thin Film Freezing Technology...
TW's Take: the versatility of thin-film-freezing is set to open up a broad swath of products that will benefit from this technology. Continue to...
The Rolling Correction Gathers Steam…
Thus endeth the worst month for the stock market since March of 2020. Friday's meltdown took the S&P to -9% for the month. It's...
It’s A Process
This past week in Charlottesville, The Boar's Head Women's Open took place. This is an annual tennis tournament featuring 32 professional tennis players, most...
TFF Announces Data from Phase 1 Study of Niclosamide
TW's Take: this is excellent data and positions Niclosamide well for potentially being a very useful covid-19 therapeutic. We are highly optimistic that UNION...
TFF Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business...
TW's Take: lots going on with TFF. While the street awaits partnerships, their internal programs advance on all fronts and they are hiring to...
TFF Pharmaceuticals Enters into CRADA with the U.S. Army and The Geneva Foundation to...
TW's Take: we are finally(!) getting a TFF covid vaccine into testing. This is a positive sign as USAMRIID must like what they have...
Groundhog Day
Another week in the market, another leg down. Some pundits are saying we are now entering a bear market. Those of us who invest...
This Trend is NOT Your Friend
Volodymyr Zelenskyy is a hero. Contrary to what I thought would happen last week, Ukraine is putting up a valiant battle, holding off the...
TFF Pharmaceuticals and Catalent Announce New Inhalation Dry Powder Development and Manufacturing Agreement
TW's Take: a solid endorsement of TFF's technology by one of largest manufacturers in the business. Catalent, an $18B company, will be using their...
TFFP: More Thoughts Regarding NICLOSAMIDE
~ This article is available for premium subscribers only. Please do not share the information here with non-premium subscribers or with company managements. Thank...
Putin It In Perspective
By the time you read this newsletter, there's a good chance that the Ukraine will be begging for a ceasefire and, basically, surrendering to...
TFF Pharmaceuticals Announces Inhaled Niclosamide Significantly Inhibits Viral Replication of the Omicron Variant of...
TW's Take: this is a very important PR for TFF. Not only does this demonstrate that TFF's version of niclosamide could be the best...
Metamorphosis
What a week in the markets, right? The past five days saw the biggest ever one day loss by a single company, followed shortly...
This Week’s Billboard Headline…Glenn Mattes Stars As Rocky Balboa!
When we had kids I was super excited to watch classic movies with them once they were old enough. Top on my list was...
TFF Pharmaceuticals Completes Enrollment in Phase 1 Study Evaluating Inhaled Formulation of Niclosamide to...
TW's Take: with data from this program expected sometime in March, Niclosamide could be a very big value driver for TFF. UNION would have...
Welcome to 2022?
So much for thinking 2022 was going to be an improvement over last year. Last Sunday I tested positive for covid then, on Monday,...
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,...
TFF Pharmaceuticals Announces Final Data from Phase 1b Study of Inhaled Voriconazole Powder in...
TW's Take: we continue to believe, and the data supports this, that TFF's internal programs are worth more than the current market cap of...
Who Believes? Santa Rally Coming…
Yesterday it was 70 degrees in Charlottesville. While playing platform tennis in a t-shirt and shorts, the comment was made that it seems unlikely...
TFF Pharmaceuticals Hosting Science Day on December 13, 2021
TW's Take: the performance of Thin Film Freezing continues to excel in all aspects. This science day should help explain the multiple competitive advantages...
Bottom Picking
My constant refrain for most of 2021 has been that I don't like the market but love the stocks in my portfolio. I can...
Is OMICRON Potentially Positive For TFF Pharma?
The latest strain of Covid-19, officially called B.1.1.529 but dubbed Omicron, struck fear in the markets last week. Omicron appears to have 30 different...
Turkey Shoot…December Preview
Well, that didn't last long, did it? On Tuesday and Wednesday we saw what looked like a great reversal for biotech. The XBI opened...
The Worst Bull Market Ever
Similar to how the richest billionaires are getting a disproportionate amount of the wealth in the US, the companies they founded are becoming an...
TFF Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Business Update
TW's Take: a great update. Feels like TFF is on the precipice of big things. In a year, we will have forgotten all about...
TFF Pharmaceuticals Announces Completion of Dosing of Phase 1b Study for Voriconazole Inhalation Powder...
TW's Take: Voriconazole is a great example of a drug whose efficacy and addressable market can be greatly improved by Thin Film Freezing. Looking...
TFF Pharmaceuticals Receives Approval from Health Canada to Enter Human Clinical Trials for Inhaled...
TW's Take: long-awaited news could lead to a rapid trial and UNION picking up the option on this drug sometime in Q1. This drug...
Saturday Morning Musings
In a slow week for news from our universe of companies, the biggest news was from TFF Pharma (TFFP) which announced pre-clinical success of...
Why TFF’s Hamster Data Is Bigger Than Investors Think
As the Delta variant of Covid-19 has demonstrated quite clearly, despite the success of the vaccine programs, the virus is here to stay. Getting...
TFF Pharmaceuticals and Augmenta Bioworks Publish Positive In Vivo Data Showing Dry Powder Formulation...
TW's Take: very bullish news. This is the first dry powder (inhalable) treatment to show positive results. It also validates the mAb platform as...
Cash is King
After several weeks of lower stock prices, the market this past week decided that the looming bankruptcy of the world's largest real estate debt...
TFF Pharmaceuticals Announces Promising Topline Results from Phase 1 Clinical Trial of Inhaled Tacrolimus...
TW's Take: very positive data. Inhaled tacrolimus is showing itself to be everything TFF claims for their products; equally efficacy at lower doses, resulting...
When The Tide Goes Out, You See Who’s Swimming Naked…
The markets had another downward-trending week since the last newsletter. However, the overall tone of the market felt better from a micro-cap investing standpoint...
A September To Remember?
I read this week where someone said, "the short story is always sexier." There's certainly a lot of truth in that. Here in September...
Summer Stocks
The markets seem to be quieting down as summer heats up and traders are heading to the beach for the last few weeks of...
TFF Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Business Update
TW's Take: TFF continues to have lots of balls in the air. The second half should be exciting with many catalysts coming together.
AUSTIN, Texas, Aug....
Are We Having Fun Yet? Bull Ride Continues
The "bull" market continued this past week although it showed signs of tiring. Which is good because the bull ride we've been on resembles...
Augmenta Bioworks and TFF Pharmaceuticals Announce Positive In Vitro Data Demonstrating Binding and Neutralization...
TW's Take: very exciting news as TFF's internal program (with partner Augmenta) appears to be effective against all strains of Covid-19. Expect to see...
TFF Pharmaceuticals Announces Completion of Enrollment and Preliminary Data from its Phase 1 Clinical...
TW's Take: we continue to believe that TAC represents a potential $1B drug and the data continues to be much better than expected or...
Kentucky Bluegrass
In a holiday shortened week, this newsletter comes from Kentucky where the TW household is attending a family wedding. Throw in a side journey...
Let’s Get Ready To Rumble (2nd Half Preview)
To steal a line from Charles Dickens, "It was the best of times. It was the worst of times. Then it was pretty darn...
Augmenta Bioworks and TFF Pharmaceuticals Announce Selection of Lead Monoclonal Antibody Candidate AUG-3387 for...
TW's Take: this is potentially a major breakthrough for regions of the world where cold-chain drug distribution doesn't exist. Looking forward to more information...
Put The Hammer Down…Backgammon Lessons
Back in February, on our trip to Miami, I was fortunate to be introduced to a friend of a friend named "Phil". Phil just...
Stock Picking Wins This Week
It was another great week for TW as the pendulum appears to be swinging full speed in our direction. This while the overall market...
TFF Pharmaceuticals Hosting Key Opinion Leader Perspectives on Thin Film Freezing Applications
TW's Take: this call should lay out a compelling thesis for the long-term disruptive case for thin film freezing. We believe this delivery technology...
Oregon Trails
Greetings from Ashland, Oregon where my tour of the west coast is ending in fine fashion. The biking here is outstanding, the meals our...
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...
Gas Lines and Inflation…Is This The 80’s?
This past week saw yet another ugly market for micro-caps as the whole investment community seems to be increasingly worried about inflation and interest...
TFF Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Business Update
TW's Take: better than expected data leading to TFF increasing the target sales for TAC to over $1B is a positive development, especially as...
The Beatings Will Continue Until Morale Improves…
Okay, I was early. I admit it. But, unless growth stocks never rally again, biotech in particular, I'm 100% convinced that buying at these...
Alpha-Bet Soup
There are times when stock picking isn't the most important part of your investment strategy. When all that matters is being in the right...
The Lows Appear To Be In Place
Earlier this year I was preaching caution. The markets were en fuego and, simply put, this cannot last. While I run pretty fully invested...
How Long Can You Hold A Soccer Ball Under Water?
Last week I wrote about INmune Bio (INMB). In that piece, In Defense of INmune, I discussed the increasing spread between perception of what's...
TFF Pharmaceuticals Awarded Contract under DARPA’s Next-Generation Personalized Protective Biosystems Program for U.S. Warfighters
TW's Take: while the size of the contract is not specified, getting into a DARPA program is a very positive validation of TFF's technology....
A Catalyst Filled Quarter Lies Around The Corner
My wife and I spent Good Friday in the car, driving up to Massachusetts to visit my number one newsletter fan; my mother. It...
2nd Degree of Risk
Investing in micro-caps always involves a high degree of risk. This risk can come in many different forms as well. For example, looking at...