TFFP Premium Subscriber Trading Update…

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This morning TFF Pharma came out with a press release discussing data from both the VORI and TAC programs as well as laying out the strategic game plan for the company. Overall I consider this to be a very positive situation. I’m long a lot of stock and am not a seller even with the stock breaking through $10. Let me break down the news and what to expect from this investment going forward.

First off, the data from both drugs was excellent. For TFF TAC, this is what they had to say (with my emphasis).

For TFF TAC, eight out of eight patients have successfully transitioned from oral Tacrolimus to TFF TAC in the Phase 2 study. There has been no evidence of acute rejection, and four out of four patients who completed the 12-week treatment period of the study chose to remain on TFF TAC and proceed to the long-term extension of the trial. 

They are batting 1,000 with their version of the drug. The oral version does not have this track record and is the reason for this statement from Zamaneh Mikhak, M.D., Chief Medical Officer of TFF Pharmaceuticals, “Based on our Phase 2 data and the overwhelmingly positive feedback that we have received from KOL and clinical investigators, we believe that TFF TAC has the potential to introduce a groundbreaking advancement.”

Regarding TFF VORI, the company had this to say.

For TFF VORI, a total of nine patients have enrolled between the Phase 2 trial and the EAP. The Company continues to see positive efficacy results, with five of six patients who have completed treatment achieving a clinical and mycologic response.

Do not dismiss this data as any less positive than TAC. Five of six patients is excellent compared to oral voriconazole and this program is no less exciting for TFFP.

That said, the company announced they will be taking TFF TAC through phase 3 and looking to partner TFF VORI off either through a strategic or government funding. Why are they doing this? Two reasons.

Financing is the biggest reason for this effort. We all know TFF needs to raise money. Through discussions with institutional investors, it became clear to management that funding one program was going to be easier than funding two. They chose TAC for the simple reason that the timeline to data inflection points in that program is significantly faster than with VORI.

At the same time, they have already had strategic interest in VORI. Dr. Weisman is nothing if not conservative with his comments and he has recently mentioned both strategic interest and government funding without any prodding. I believe they are proceeding down this path and feel comfortable with it happening in a reasonable timeframe.

How does this all play out in the market?

My guess is they raise $10-20M after the investor update conference call next week. Hopefully this is done with solid institutions and roughly in line with the market. The quality of the financing is going to be very important. At this valuation, and with the team executing well, I believe they can get a good deal done.

As I’ve said before, the financing will be a positive catalyst. Even if they go from $20M to $40M in market cap, you’re looking at a $1B drug entering phase 3 and another $1B drug hopefully partnered off in 3-6 months. Theoretically, this could be the last financing needed before getting TAC to approval. The market cap should be multiples of where this is trading.

So, my thinking is we trend higher then have the chance to really go post financing. I’m sticking with my position and excited to see how this plays out. At this market cap, however the chips fall, I don’t see much downside and plenty of upside.

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    • Unbelievable. I’m going to lose a ton of sleep over this one. What could have been a great situation is now a hole in Harlan’s foot with a smoking gun in his hand.

      • That’s funny. After listening to the ROTH conference I felt really good about the next two weeks until they made that move. I’m curious, do you think using the ATM would have been effective? I really wonder why they would put out such a positive press release and at least not wait to see what the reaction was. They could have easily dribbled a couple hundred thousand shares in over the next few days if they really needed to. HCW must have seen this as their last chance to scalp them. I mean TFF knows they have a good hand, they know the data, and it seems obvious at this market cap that the stock will run on the news. It’s like they folded with a Royal Flush, or maybe a straight flush. Either way, the odds were heavily in their favor.


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