FORT WORTH, Texas - TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company, announced today that it has engaged Outcome Capital, a specialist investment bank, to explore potential corporate partnerships and licensing opportunities for its drug products. This move aims to capitalize on the company's two leading clinical assets, TFF VORI and TFF TAC, both based on its proprietary Thin Film Freezing (TFF) technology.
Chief Executive Officer Dr. Harlan Weisman expressed optimism about the collaboration's potential to deliver value to shareholders. He highlighted the innovative nature of the company's clinical assets, which are currently in Phase 2 trials.
TFF TAC, one of the assets, is an inhaled dry powder form of the immunosuppressive drug tacrolimus. This formulation is designed to lower systemic exposure and reduce associated toxicities, such as kidney damage, compared to the oral version of the drug.
The ongoing Phase 2 trial aims to assess the safety, tolerability, and pharmacokinetics of TFF TAC, particularly in lung transplant patients experiencing kidney toxicity from oral tacrolimus.
TFF Pharmaceuticals' TFF technology platform is notable for its ability to convert a wide range of drugs into dry powder formulations. These formulations are intended to improve bioavailability, accelerate onset of action, and enhance safety and efficacy by delivering drugs directly to the targeted organ.
The technology is also applicable to vaccines, small and large molecules, and biologics, creating dry powders suitable for various administration routes, including inhalation and topical application.
Despite the company's progress and the promising features of its technology, no product incorporating the TFF platform has yet received FDA pre-market approval or been included in a commercial drug product. TFF Pharmaceuticals has also not established any agreements with large pharmaceutical companies for the development of a drug product incorporating the TFF Platform.
The engagement with Outcome Capital is part of TFF Pharmaceuticals' broader strategy to realize the full potential of its Phase 2 assets. The information for this article is based on a press release statement from TFF Pharmaceuticals, Inc.
In other recent news, TFF Pharmaceuticals has made substantial progress in its ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC), aimed at preventing lung transplant rejection. The company has received constructive feedback from the FDA regarding the TFF TAC clinical program. The FDA's response emphasized the potential therapeutic benefits of mitigating or preventing tacrolimus-associated toxicities, particularly in lung allografts, without increasing risk.
The company also launched a public offering of shares and warrants, expecting to raise approximately $4.8 million in gross proceeds. The net proceeds are intended for working capital and general corporate purposes.
Jones Trading has adjusted its outlook on TFF Pharmaceuticals' shares, lowering the 12-month price target to $4.00 from the previous $13.00. This adjustment reflects concerns about the long-term risks associated with TFF Pharmaceuticals' reliance on the development of a single clinical asset, TFF TAC. Despite this, the firm maintained a Buy rating on the stock.
Furthermore, TFF Pharmaceuticals announced positive data from its ongoing Phase 2 study evaluating TFF TAC for organ rejection prevention in lung transplant recipients. The data showed that TFF TAC could prevent rejection with lower doses and systemic exposure compared to oral tacrolimus.
Based on these findings, TFF Pharmaceuticals plans to pursue an Investigational New Drug (IND) application in the United States to explore TFF TAC's use immediately post-transplant, in preparation for a registrational trial.
InvestingPro Insights
In light of TFF Pharmaceuticals' recent strategic decision to explore corporate partnerships and licensing opportunities, some key financial metrics and analyst insights from InvestingPro provide a broader context for potential investors. With a modest market capitalization of just 6.1 million USD, the company is positioned in a challenging financial landscape. Notably, TFF Pharmaceuticals holds more cash than debt, which may offer some financial flexibility as they seek partnerships and licensing deals.
Still, the company is facing significant financial pressure, as evidenced by a rapid cash burn and a substantial gross profit margin deficit, reported at -1198.52% for the last twelve months as of Q1 2024. Furthermore, the company has not been profitable over the last twelve months, which aligns with analysts' expectations of a sales decline in the current year.
The valuation of TFF Pharmaceuticals also implies a poor free cash flow yield, indicating concerns about the company's ability to generate sufficient cash flow relative to its valuation.
The company's stock performance reflects these financial challenges, with the price having fallen by 83.44% over the last year. This decline is part of a longer-term downward trend, with significant price drops over the last three and six months as well. TFF Pharmaceuticals does not pay a dividend to shareholders, which may deter income-focused investors.
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