TFF Pharmaceuticals, Inc.

NasdaqCM:TFFP 株式レポート

時価総額：US$288.8k

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TFF Pharmaceuticals マネジメント

マネジメント 基準チェック /14

現在、CEO に関する十分な情報がありません。

主要情報

Craig Jalbert

最高経営責任者

n/a

報酬総額

CEO給与比率n/a
CEO在任期間less than a year
CEOの所有権n/a
経営陣の平均在職期間データなし
取締役会の平均在任期間3.3yrs

経営陣の近況

Recent updates

分析記事 • Apr 10

Can TFF Pharmaceuticals (NASDAQ:TFFP) Afford To Invest In Growth?

Just because a business does not make any money, does not mean that the stock will go down. For example, biotech and...
分析記事 • Sep 27

Is TFF Pharmaceuticals (NASDAQ:TFFP) In A Good Position To Deliver On Growth Plans?

We can readily understand why investors are attracted to unprofitable companies. For example, although Amazon.com made...
Seeking Alpha • Aug 29

TFF Pharma: The Potential Is Still Very Much Present

Summary While the company added three more big pharma partners, this is not what shareholders prefer to hear as the company already has more than two dozen of these. These partnerships are mostly in the pre-clinical phase and are unlikely to lead to near-time monetization. For monetization, there are four near-time candidates, Voriconozale and Tacrolimus look to be the most certain candidates but PLUS (cannabis) and UNION (Niclosamide) are additional deal candidates. A deal is necessary as cash levels are getting low, which might necessitate earlier partnering and forfeiting some future revenue. But just one deal with upfront payments is likely to considerably improve their situation so the stock remains very interesting. TFF Pharma (TFFP) has a unique platform, Thin Film Freezing, to turn drugs into an inhalable form which produces a host of benefits: Many drugs are not well absorbed orally, for instance, because they don't dissolve in water. An inhalable form bypasses digestion which enables much lower dosages with lower toxicity, side effects and possible drug-drug interactions. They also bring the drug directly to affected areas in case of lung and airway problems (or pathway for the line of attack, as in the case of airborne viruses). Dry powder form greatly extends the shelf-life of drugs and vaccines and bypasses cold-chain storage of some vaccines. Management also claims their TFF platform is better than alternative forms of dry powder inhalable formulation techniques: TFFP IR presentation The company's specialists recently published a scientific paper (written by the co-inventor of Thin Film Freezing, Bill Williams, Improved Formulations to Enable Stable Delivery of Biologics published in BioPharm International) buttressing the advantages of TFF over other dry powder formulations, in short summary: Dry-freezing leads to aggregation in many cases which can negatively impact bioactivity. TFF formulations don't suffer from this. TFF formulations don't suffer from this. Many biologics are vulnerable and cannot withstand the impact of shear and stress or elevated temperatures during the drying process. TFF formulations don't suffer from this. TFF dry powder formulations preserve bioactivity until 40 degrees Celcius, eliminating cold-chain distribution and storage (which led to $1B+ of Covid vaccine destruction recently). This also holds for vaccines containing the MF59 adjuvant (which require refrigerated storage, but not in TFF powder form). Vaccines with MF59 are also sensitive to accidental slow freeze conditions, which TFF formulations obfuscate. TFF formulations of vaccines and drugs for respiratory illnesses seem particularly promising and management argues that they are working with a number of vaccine producers, but they have said so for quite some time Yet despite all these compelling benefits it is one of our more frustrating holdings. There is so much potential, and so many possible use cases and partnerships, but nearly all of the progress is made at the pre-clinical stage where they continue to add drug candidates and pharma partners, many of which we discussed in previous articles (see here and here). It is true that these involve reformulations for already approved drugs and therefore the reduced 50((B))(2) regulatory pathway is not as taxing but this still is a matter of years rather than months but investors hoped that there would be more progress on the monetization front by now. Business model TFFP IR presentation The internal development program produces TFF dry powder form of drugs for which patents are expired and the costs are born by TFF Pharma, but at some stage, partnerships are sought to share the clinical trial cost. The company has four internal development programs (Tacrolimus, Voriconazole, Niclosamide, and Augmenta 3378, an inhaled form of monoclonal antibodies) with Vori and Tac in stage 2 clinical trials as the most advanced of these. Both drugs have significant market opportunities, here is Tacrolimus TFFP IR presentation And for Voriconazole: TFFP IR presentation The both have phase 2 results expected in Q3 and the idea is that management will look for partnerships (Q2CC): As previously discussed, we intend to partner these programs and we're currently working with Torreya Partners to reach out broadly to potential interested companies. This would bring urgently needed revenues with the company sitting on just $20.9M of cash and cash equivalents, which won't last them even a year. UNION Therapeutics could also offer a deal as the results from the phase 1 Niclosamide study were positive and the Covid situation looks to scream for a product like this, from the Q2CC: And many of the patients that die are in high risk categories, cancer patients, patients who can't take Paxlovid due to drug-drug interactions. And we think that those patients will benefit from inhaled Niclosamide because they're -- again like Voriconazole when we deliver to the lung, you can avoid drug-drug interactions. And we've also seen that from the Paxlovid rebound, it's very clear that BA.5 and potentially future variants will take longer. UNION has an option for worldwide licensing which is likely to contain at least some upfront payment. To give you some idea of the possible sums involved, from the linked PR: 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. Management proposed a sort of new model going forward based on the Augmenta 3387 monoclonal antibodies deal (Q2CC): Augmenta, we were going to take through Phase 1 and still might, and then split proceeds from that point on. So we have a number of different options available to us as we seek to -- we kind of refresh and serially look at taking products through the pipeline. In general, Jonathan, it takes about $7 million to $12 million depending on the cost of the API to get us to that inflection point. It seems like a reasonable cost-saving way to shift the internal development projects once these are taken to their inflection points with monetization deals in place. However, there is a trade-off as future revenues will be lower the earlier a project is shared with commercial partners. This new handing over after phase 1 trials are completed might have a direct impact on the situation with UNION and TFF formulations of Niclosamide. On slide 23 of their August 2022 IR presentation there was a footnote that Niclosamide would begin phase 2 trials in Q3/22 with the proviso that it would transition to UNION. It wasn't all that long ago that the Roth had a 12 month price target of $27 based on 4x 2030 operating income of $195M from royalties (Vori, Tac and cannabis, so plenty of upside from other programs). If these royalties are lower because partners assume cost of development then this is at the detriment of their long-term revenue perspective, but it looks like the company has little choice. Partnerships The company isn't just dependent on their own development work, they partner with a host of pharma companies from the start as well. The company has over two dozen partnerships with pharma companies to produce dry powder form for one or more of their drugs and continues almost every quarter to add to these. They did so again and gained 3 more top-20 pharma partners in Q2, which is of course significant but not leading to any immediate revenue generation as these are almost certainly early-stage pre-clinical lab-bound formulation agreements.
Seeking Alpha • Aug 09

TFF Pharmaceuticals: Q3 Data Is Pivotal In So Many Ways

Once promising, TFF Pharma is now cash-strapped and stagnant. TFFP badly needs some good news. Q3 interim data may provide that. TFF Pharmaceuticals (TFFP) works with a novel method of producing dry powder formulation of known drugs. Licensed from UT Austin and initially developed by Dow, this technology has advantages over the two other known dry powder formulation technologies. Like I noted before: There are competing and time-tested methods of producing dry powder formulations of medicines. Spray drying, which uses heat to cause evaporation, is one - however, this method does not produce adequate porosity for deep lung delivery. Lyophilization is a slower method which does, but it increases risks of molecular degradation and contamination. TFF overcomes the inadequacies of both methods, producing dry powder drugs 100x to 1000x faster than the latter method, and enables deep lung delivery of known-efficacy common drugs. I covered TFFP thrice last year, and the stock has been something of a laggard, mainly, I suspect, due to a data desert. Today, the company has two programs in phase 2 - TFF Vori for Invasive pulmonary aspergillosis ((IPA)) and TFF-TAC-LAC for the prophylactic treatment of lung transplant rejection. Other programs are in earlier phases. Both these projects completed phase 1 proof of concept trials last year. Phase 2 is ongoing; interim analysis is due in 2H 2022. Voricanozole is already approved to treat aspergillosis in patients 12 years or older. However, the drug comes with significant side effects and loss of function due to the inefficient mode of delivery. An alternative to vori is Oral and IV amphotericin; TFF-Vori has shown 3x better survival than amphotericin in IPA. It is also able to address the disease in children as young as 2 - a result of its better safety profile, doubtless. The company states that "dosages up to 80mg twice daily showed no signs of the clinically significant hepatic or visual toxicities previously reported for the oral or intravenous forms." As the company also says, Voricanozole comes with a long list of liver and visual toxicities: Hepatic toxicity, including clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities Visual disturbances, including optic neuritis and papilledema Other research I accessed says: Voriconazole use has increased since the drug's introduction in 2002, and new and unique adverse effects are emerging as patients undergo prolonged therapy. Most concerning is the increased risk of cutaneous malignancies, primarily squamous cell carcinoma ((SCC)); this risk is duration dependent and the associated malignancies tend to be more aggressive and multifocal. Voriconazole is also associated with phototoxicity (which may be a precursor to malignancy), periostitis, hallucinations and encephalopathy, peripheral neuropathy, alopecia, nail changes, hyponatremia, and other adverse effects. Some toxicities (neuropsychiatric and gastrointestinal including hepatic) are seen in clear association with supratherapeutic serum voriconazole levels… So it is noteworthy that treatment with TFFP's version of voriconazole did not elicit such adverse responses in patients as of now. However, this is also a matter of concern, going forward. As earlier research with inhaled vori has noted: Inhaled voriconazole reduces histological manifestations of invasive aspergillosis in rodents [3] and it has been proposed that a favourable lung tissue to plasma concentration ratio is obtained through this route of administration [4]. Consequently, inhaled voriconazole may provide higher concentrations at the site of infection without increasing the risk of systemic side-effects. The above cited research produces another cause of concern, one that I have dwelt on earlier in my TFFP coverage. The company needs to be cautious with its intellectual property. They have patents running to 2035, and they have a certain trade secret about the particular cooling temperature - these are the two competitive barriers they have available. However, inhaled vori has been used before - and although their particular method of dry powder formulation is likely novel, I suspect a successful approval will attract generic drugmakers and IP lawsuits.
Seeking Alpha • Jul 14

TFF Pharmaceuticals expands R&D operations with new Austin facility

TFF Pharmaceuticals (NASDAQ:TFFP) has announced a significant expansion of its R&D operations through the lease of a new research and development facility located in Austin, Texas. As TFF expands its in-house and partnered research, including applications in biologics, the additional laboratory space will also provide significantly more real estate to accommodate larger equipment to facilitate scale-up and manufacturing. The Co. also plans to expand the product development team in Austin, which will be based at the new facility, to support the growing number of partnered projects. “As our internal programs advance and our network of partnerships expands, establishing this additional research space in Austin is a natural next step,” added Glenn Mattes, CEO of TFF Pharmaceuticals.
Seeking Alpha • May 23

TFF Pharmaceuticals: A Highly Attractive Basket Of Options

TFFP is a platform company with leading technology. Clinical/FDA risk is extremely low. The stock is drastically undervalued based on only fraction of the pipeline and multiples of upside. Multiple insider purchases support the bull case and timing.

CEO

Craig Jalbert (62 yo)

less than a year
在職期間

Mr. Craig R. Jalbert serve as a CEO, President, Chief Financial Officer, Treasurer and Secretary and sole member of the board since November 2024 at TFF Pharmaceuticals, Inc. He is President, Treasurer, CS...

取締役

名称ポジション在職期間報酬所有権
Craig Jalbert
CEO, Presidentless than a yearデータなしデータなし
Anthony Hickey
Chairman of the Scientific Advisory Board and Senior Research & Development Advisor1.9yrsデータなしデータなし
David Denning
Member of Scientific Advisory Board3.3yrsデータなしデータなし
Drew Weissman
Member of Scientific Advisory Board3.3yrsデータなしデータなし
Ted Ross
Member of Scientific Advisory Board3.3yrsデータなしデータなし
Mike Saag
Member of Scientific Advisory Board3.3yrsデータなしデータなし
David Cornfield
Member of Scientific Advisory Board3.3yrsデータなしデータなし
Jay Peters
Member of Scientific Advisory Board3.3yrsデータなしデータなし
3.3yrs
平均在職期間

経験豊富なボード: TFFPの 取締役会 は 経験豊富 であると考えられます ( 3.3年の平均在任期間)。

企業分析と財務データの現状

データ最終更新日（UTC時間）
企業分析2024/12/15 14:58
終値2024/12/12 00:00
収益2024/09/30
年間収益2023/12/31

データソース

企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。

パッケージデータタイムフレーム米国ソース例
会社財務10年
  • 損益計算書
  • キャッシュ・フロー計算書
  • 貸借対照表
アナリストのコンセンサス予想+プラス3年
  • 予想財務
  • アナリストの目標株価
市場価格30年
  • 株価
  • 配当、分割、措置
所有権10年
  • トップ株主
  • インサイダー取引
マネジメント10年
  • リーダーシップ・チーム
  • 取締役会
主な進展10年
  • 会社からのお知らせ

* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。

特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。

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アナリスト筋

TFF Pharmaceuticals, Inc. 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。4

アナリスト機関
Mayank MamtaniB. Riley Securities, Inc.
Raghuram SelvarajuH.C. Wainwright & Co.
Jason McCarthyMaxim Group