This company has a proprietary patented technology to make certain drugs inhalable that otherwise wouldn't be. Signed a contract with 210 million in milestone payments, which is about equivalent to its current market cap. This is just a single drug. Future licensing powerhouse in the making?Under the terms of the agreement, UNION will acquire an option to obtain a worldwide exclusive license of TFF Pharmaceuticals to its TFF technology to be used in the field of niclosamide, including oral and inhalation versions of niclosamide, potentially for COVID-19, as well as other niclosamide-based therapies. Subject to UNION’s exercise of its option, UNION has agreed to pay TFF Pharmaceuticals potential development, regulatory and sales-related milestone payments of up to $210 million. UNION will also pay TFF tiered single-digit royalties on product sales. TFF Pharmaceuticals and UNION have agreed to collaborate on securing government support (contracts, grants, etc.) with the aim of funding the development of niclosamide-based products for the treatment of COVID-19.Niclosamide is an oral anthelminthic drug, first approved by the US FDA for use in humans in 1982 and is included in the World Health Organization's list of essential medicines1. It has been used to safely treat millions of patientshttps://www.marketwatch.com/press-release/tff-pharmaceutical...
Good Phase 1 results for Voriconazole using the TFFP thin film freezing tech. Approved drug but high toxicities and drug-drug interactions when used as directed. The TFFP technology to make into inhaled powder may achieve efficacy at much lower doses with many fewer side effects. This seems to be another example of a potential monster platform and moving quickly on trials. With COVID angle to this drug, potential for data on compassionate use too.https://flashalert.me/?symbol=TFFP&source=PR&referer...
Good writeup on the TFFP technology and potential markets and partnering opportunities:All told, TFF is currently working on material transfer agreements and statements of work with 20 different companies on vaccines, biologics, new chemical entities and botanicals, including UNION Therapeutics (niclosamide), the University of Georgia (flu vaccine), and the U.S. Amy (antiviral monoclonal antibodies and antivirals). That’s in addition to the company’s three internal programs; a dry powder formulation of voriconazole to treat Invasive Pulmonary Aspergillosis, the immunosuppressive drug tacrolimus used in solid organ transplants, and an inhaled dry powder drug combination intended to treat COPD and asthma. Those programs are operating under the 505(b)(2) regulatory pathway intended for molecules that have been previously approved by the FDA as safe and effective.Market cap is now about 400 million or 2x the the $210 million in milestone payments contracted for their first drug. I have a full position now considering nibbling to go a bit overweight. It seems to me things are moving much faster than a typical pharmaceutical company since they are working with previously approved molecules.2K10
Newly published article with data on TFFP process on another drug:"Bioavailability Improvement of Carbamazepine via Oral Administration of Modified-Release Amorphous Solid Dispersions in Rats"https://www.mdpi.com/1999-4923/12/11/1023/htmCarbamazepine (CBZ, Figure 1A), as a commonly prescribed antiepileptic drug, is widely used in the treatment of various forms of epilepsy in the clinic. In recent years, new antiepileptic drugs, including gabapentin, lamotrigine, topiramate, and others, have been marketed, but these drugs are still in the evaluation process of evidence-based medicine and are relatively expensive. CBZ remains the first-line antiepileptic treatment drug.
Another partnership -- 50/50 deal to develop a COVID-19 monoclonal antibody therapeutic. This is about delivering the antibodies directly to lung instead of through IV.TFF Pharmaceuticals, Inc. and Augmenta Bioworks, Inc. Enter Into a Worldwide Joint Development Agreement for COVID-19 Monoclonal Antibody Therapieshttps://www.biospace.com/article/releases/tff-pharmaceutical...
A letter of intent for another development deal using the TFFP Thin Film Freezing technology. Possible 281 million in milestone payments + royalties on this deal.https://flashalert.me/?symbol=TFFP&source=PR&referer...They also had earnings release yesterday and have recently announced a shelf offering so lots of news potentially to move the stock. Up about 8% today at this point.
The analysts of H.C. Wainwright & Co. have rated TFF Pharmaceuticals with a Buy rating. The price target was set to $ 31.00. At a current price of $ 19.54 there is upside potential of 58.65%.https://markets.businessinsider.com/analysts-opinions/tff-ph...TFFP has a couple shots on goal, including a few COVID plays. Potential licensing powerhouse IMHO. Also plenty of writeups on this at Tailwinds Research site. https://tailwindsresearch.com/
https://ir.tffpharma.com/news-releases/news-release-details/...TFF Pharmaceuticals Announces Completion of Enrollment and Preliminary Data from its Phase 1 Clinical Trial of Tacrolimus Inhalation PowderJuly 13, 2021 at 8:00 AM EDTInhaled Tacrolimus Powder Achieves Systemic Therapeutic Drug Levels Anticipate Additional Safety Data in 3Q 2021 Initiation of Lung Transplant Study Expected in 2H 2021The stock sits around $10, unloved right now, $250M market cap. But, it seems to me a potential long term winner, a licensing powerhouse. Multiple drug candidates in testing. In cases like Tacrolimus they are taking approved drugs and making them into an inhalable powder that allows for lower doses to reduce side effects like toxicity.
Thanks 2K for bringing this company to the boards. I re-read all of your posts regarding TFFP and finally opened a position today.
TFFP has a couple shots on goal, including a few COVID plays. Potential licensing powerhouse IMHO. Also plenty of writeups on this at Tailwinds Research site. https://tailwindsresearch.com/I have been following TFFP over at TW, one of their higher conviction picks but at the moment the market doesn’t have much love for them. I exited a while ago but likely re-establish a position at these levels.
Like many biotech stocks 2021 has not been a good year for TFFP stock price. But with this one, I remain hopeful that progress of the programs remain on track. On the Nov 15 earnings call they expressed that they have communicated a strong desire to close some agreements by the end of the year. Today they announced a 'Science day' on Dec 13. So hopefully in next couple weeks some good progress and good PRs will light a fire under stock price for strong finish from here. https://seekingalpha.com/article/4469794-tff-pharmaceuticals..."It’s certainly great news that many of our current partners with open MTAs and SOWs are large commercial-stage pharmaceutical companies. The pace of moving forward with these companies can be a challenge. The process has led to extended evaluations and, in some cases, are taking a bit longer than we expected. We do not have the ability to accelerate these discussions. We have communicated our strong desire to close these agreements by the end of this year and remain confident that this will happen. We strongly believe that we’re on track. We will communicate and update the status of this work and ongoing negotiations."
Yesterday morning TFFP released positive Phase 1b results and later uploaded a new investor presentation to SEC. I think this is the first time in print they note a collaboration with Pfizer. It says they will work on multiple drug candidates with Pfizer, terms undisclosed. Other good nuggets in there I'm sure. This may be reason for today's 13% bump. I think they crossed 200 day MA today. I am hoping for a significant and sustained change in price trajectory.https://www.sec.gov/Archives/edgar/data/1733413/000121390021...
Not that I trust benzinga as a great resource but they pull together highlights of recent developments on TFFP here in new article out last night.They rely on research/analysis by Dan Carlson which is where I get my TFFP research from so this its not an independent conclusion. But its a great intro/overview to the bull case:https://www.benzinga.com/trading-ideas/22/01/24985815/recent...
New deal for TFFP with US Army:TFF Pharmaceuticals Enters into CRADA with the U.S. Army and The Geneva Foundation to Develop Dry Powder Needle-free Medical CountermeasuresMarch 17, 2022 at 8:00 AM EDTNew collaboration to study the use of Thin Film Freezing technology to formulate dry powder recombinant vaccine against SARS-CoV-2 for pulmonary deliveryhttps://ir.tffpharma.com/news-releases/news-release-details/...
New deal for TFFP with US Army:I’d like to think of a deal as being revenue generating, this still is a collaboration with no idea if they will make revenue from it. I am not sure what to make if this company as when I look on Yahoo it only lists 4 employees. When I check their management team, there seems to be 9. But of I google other sources, it still very small. LinkedIn shows 15 but I usually find they overestimate as people don’t often update when they leave as much as they do when they join
Yes this company is very small and not a lot of info out there. I've said before I read Tailwinds Research coverage of TFFP but Tailwinds has been paid to promote this and many other small cap stocks so you have to take it with a grain of salt. Yesterday he said on StockTwits the selling pressure on the stock was likely Jeffries unloading a large position.The SEC quarterly and annual forms may provide the best information,Yesterday report to SEC of large insider buy has stock advancing 10% in early trading:SEC Form 4: Fletcher Aaron G.L. bought $3,504,380 worth of shares (542,000 units at $6.47)https://quantisnow.com/insight/2675343
https://ir.tffpharma.com/news-releases/news-release-details/...TFF Pharmaceuticals Announces Safety and Pharmacokinetic Data from Phase 1 Study of Niclosamide Inhalation PowderApril 19, 2022 at 8:00 AM EDTNiclosamide Inhalation Powder Well Tolerated with No Serious Adverse Events Across All Subject CohortsCurrent Data Suggests Niclosamide Inhalation Powder is a Promising Antiviral Treatment to Combat COVID-19UNION Therapeutics A/S has an option to exclusively license the dry powder formulation of niclosamide, in which case it would take over responsibility for further development.https://uniontherapeutics.com/union-therapeutics-a-s-enters-...I hear UNION has 45 day period to excercise their option to develop...Under the agreement, UNION will pay TFF up to 210 million USD related to option exercise, development and commercial milestones, as well as tiered single-digit royalties on product sales.
Good to finally see some traction on a potential partnership. Not sure how quickly they could get a Phase 1 study to approved drug but maybe given it is very treatment of Covid perhaps relatively quicker???Details will be in how the $210M gets appropriated, I wouldn’t expect anything too big if they decided to excercise after 45days. While Union is a private company, they seem to have a financial release. Maybe a Danish requirement?https://uniontherapeutics.com/union-therapeutics-announces-f...At least they seem to have cash on the balance sheet of 253M DKK which is about $368M. They ran an operating loss of 52M DKK which is about $76M. They were able to raise about $290M last year in private placements.I don’t hold TFFP but been a casual observer for a while…
I think the $210 in milestones would be if UNION can progress the drug all the way through P2, P3, and beyond. Maybe a 5% payment e.g. $10M initial milestone here for completing this P1 phase. Presumably UNION would pick up the majority of expenses from here on out though.I've given up hoping any new drug from any company gets quick COVID approval.However there are other potential catalysts coming on tacrolimus, voriconazole, cannabis, and more to look forward to.
Update? Now at $6
I don’t think anything to update, no sign any milestone payments are about to happen.
I heard on another service that the Niclosomide results that were PR'd April 19 sometimes thereabouts started a clock ticking on this option: UNION Therapeutics A/S has an option to exclusively license the dry powder formulation of niclosamide, in which case it would take over responsibility for further development.https://www.globenewswire.com/en/news-release/2022/04/19/242...Some people thought it was 60 or 90 days to exercise the option but that the clock did not start ticking exactly on 4/19, maybe a bit later.That poster on the other service estimated about $10M initial payout and then other milestone and royalty payments as the development progressed.
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