FORT WORTH, Texas - TFF Pharmaceuticals, Inc. (NASDAQ:TFFP), a clinical-stage biopharmaceutical company, has announced positive preclinical results for its universal influenza vaccine candidates. This new development, based on the company's patented Thin Film Freezing (TFF) technology, has shown promise in inducing neutralizing antibodies against multiple influenza strains in ferrets, an animal model closely related to human responses to respiratory diseases.
The vaccine candidates, which are in the form of a dry powder for intranasal administration, have been developed in collaboration with Dr. Ted Ross, Global Director of Vaccine Development at Cleveland Clinic. The preliminary data indicate that these candidates can generate protective antibody titers against the H1 and H3 influenza strains. No response was detected in animals that were given a mock vaccine.
TFF Pharmaceuticals' CEO, Dr. Harlan Weisman, stated that the data support the ongoing development of a shelf-stable, self-administered mucosal universal influenza vaccine. The goal is to create a vaccine effective against a broad spectrum of influenza strains, which could change from year to year.
Further studies are underway to evaluate the vaccine candidates against a wider range of influenza A viruses, encompassing isolates from 2006-2018 for H1N1 and 2012-2019 for H3N2 subtypes. Following viral challenge, the ferrets will be monitored for clinical signs and symptoms as well as antibody titers.
The research is funded by a Direct to Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The grant, approximately $2.97 million, is aiding the advancement of the vaccine candidate toward Investigational New Drug (IND) status and early clinical trials.
TFF Pharmaceuticals' TFF technology allows for the transformation of various compounds into dry powder formulations suitable for multiple routes of administration, potentially improving bioavailability and reducing side effects. The dry powder form also offers advantages in storage and distribution, particularly in regions with limited access to refrigeration.
This news is based on a press release statement and comes amid the company's efforts to out-license the vaccine candidate, which, if successful, could generate significant revenue. However, TFF Pharmaceuticals cautions that the collaboration with Cleveland Clinic may not necessarily lead to a successful vaccine development, and there are risks associated with the ongoing research and the need for additional capital to continue operations and trials.
In other recent news, TFF Pharmaceuticals has made significant strides in their ongoing Phase 2 clinical trial of Tacrolimus Inhalation Powder (TFF TAC) for lung transplant rejection prevention. The trial data shows promising preliminary results, with no signs of acute rejection in patients. The company has also announced the resignation of Michael Patane from its Board of Directors, effective June 30, 2024, with no immediate successor named. Furthermore, TFF Pharmaceuticals has engaged Outcome Capital to explore potential corporate partnerships and licensing opportunities for its drug products. Jones Trading has adjusted its outlook on TFF Pharmaceuticals' shares, maintaining a Buy rating despite lowering the 12-month price target. In financial developments, the company has launched a public offering of shares and warrants, expecting to raise approximately $4.8 million. These are recent developments that continue to shape the future of TFF Pharmaceuticals.
InvestingPro Insights
As TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) continues to innovate in the biopharmaceutical space with its universal influenza vaccine candidates, the company's financial health and market performance provide additional context for investors. According to InvestingPro data, TFF Pharmaceuticals holds a market capitalization of approximately $6.76 million USD, reflecting the current valuation of the company in the market.
Investors tracking TFFP's performance will note a striking revenue growth of 53.17% in the last twelve months as of Q2 2024, signaling a robust upward trend in the company's sales figures. This is complemented by an even more impressive quarterly revenue growth of 95.06% in Q2 2024, which could be indicative of the company's potential to scale its operations and increase its market share.
However, it is crucial to consider that TFF Pharmaceuticals has been facing significant challenges as well. One InvestingPro Tip points out that the company is quickly burning through cash, which is a critical factor for investors to monitor, especially for a clinical-stage company that is heavily reliant on research and development activities. Additionally, TFFP's gross profit margins have been weak, with a reported gross profit of -$10.2 million USD in the last twelve months as of Q2 2024, reflecting a margin of -847.92%. This suggests that the cost of goods sold vastly exceeds the revenue generated from those sales, a situation that may require strategic adjustments to become sustainable in the long term.
For investors seeking a deeper analysis, there are additional InvestingPro Tips available, including insights on valuation, profitability, and stock performance metrics. As of the latest data, TFFP does not pay a dividend to shareholders, which may influence investment decisions for those seeking regular income streams from their holdings.
The InvestingPro platform offers a comprehensive set of tips for TFF Pharmaceuticals, with a total of 8 tips available to subscribers seeking more detailed investment guidance. For those interested in exploring these insights, they can be found at https://www.investing.com/pro/TFFP.
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