TFF Pharmaceuticals, Inc. - TFFP STOCK NEWS

TFF Pharmaceuticals (Nasdaq: TFFP) announces positive preclinical data published in the Journal of Drug Delivery Science and Technology, validating its Thin Film Freezing (TFF) technology as a superior approach for formulating dry powders for pulmonary drug delivery. The study compared TFF inhalational dry powders with jet-milling and spray-drying technologies in a rat model, demonstrating:

• Enhanced uniform drug distribution in the lungs
• Lower airway-to-lung distribution ratio
• Rapid disaggregation of particles and subsequent movement of TFF nanoaggregates

TFF processed voriconazole dry powder showed the most homogeneous distribution in lung tissue, with the lowest airway-to-lung voriconazole deposition ratio (1.27) compared to spray-dried (1.76) and jet-milled (2.73) powders. These results suggest TFF inhalational dry powders may enhance treatment efficiency and reduce toxicity for lung diseases.

TFF Pharmaceuticals (Nasdaq: TFFP) has partnered with Emory University and BARDA to develop a dry powder inhaled mRNA-based treatment for Influenza and COVID. This collaboration, funded by BARDA and other US government agencies, aims to test the feasibility of converting Emory's mRNA-based Cas13a antiviral into a dry powder formulation using TFF's Thin Film Freezing technology. The project's goals include more precise inhalational delivery, improved stability, and widespread distribution without cold-chain storage.

The partnership is part of BARDA's Flexible and Strategic Therapeutics (FASTx) program, designed to develop rapidly adaptable platforms to combat viral threats. TFF's technology could potentially enhance the efficacy of antiviral therapies by delivering the drug directly to where respiratory viruses replicate, while also improving practicality for distribution.

TFF Pharmaceuticals (Nasdaq: TFFP) has announced positive preclinical data for their bivalent universal influenza vaccine candidates manufactured using Thin Film Freezing (TFF) technology. The study, conducted in collaboration with Dr. Ted Ross from Cleveland Clinic, showed that TFF-dry powder HA antigen vaccine candidates induced neutralizing antibody titers in ferrets against H1 and H3 influenza strains when administered intranasally.

The research, funded by a $2.97 million NIAID grant, aims to develop a shelf-stable mucosal universal influenza vaccine that could be effective against multiple strains and self-administered. Ongoing studies will assess antibody titers against a broader panel of influenza A viruses. The company's goal is to advance a vaccine candidate to IND and early clinical trials, with potential for significant market impact if successful.

TFF Pharmaceuticals (NASDAQ: TFFP), a clinical-stage biopharmaceutical company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, at the Lotte New York Palace Hotel. Dr. Harlan Weisman, CEO of TFF Pharmaceuticals, will present a corporate overview on September 9, 2024, available on-demand starting at 7:00 AM Eastern Time.

Investors can access the presentation webcast through the company's investor relations website. The replay will be available for approximately 90 days after the event. Additionally, Dr. Weisman and Kirk Coleman, CFO, will be available for one-on-one meetings throughout the conference. TFF Pharmaceuticals focuses on developing innovative drug products using its patented Thin Film Freezing technology platform.

TFF Pharmaceuticals (NASDAQ: TFFP) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

1. Positive data from Phase 2 trial of TFF TAC for lung transplant rejection prevention
2. Accelerated patient enrollment with 13 patients now enrolled
3. Engagement of Outcome Capital for strategic partnerships
4. Advancement of next-gen medical countermeasures with U.S. government
5. Progress on universal influenza vaccines with Cleveland Clinic

Financial results:
- Cash and equivalents: $4.4 million as of June 30, 2024
- R&D expenses: $2.6 million, down 3% YoY
- G&A expenses: $2.0 million, down 24% YoY
- Net loss: $4.5 million, decreased from $5.0 million YoY

TFF Pharmaceuticals (NASDAQ: TFFP) has reported positive outcomes from its ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for preventing lung transplant rejection. Key highlights include:

1. Accelerated patient enrollment with 13 patients now in the trial.
2. TFF TAC at ~20% of oral tacrolimus dose prevented acute rejection and achieved >80% of oral trough blood levels.
3. 100% of patients completing 12-week treatment chose to continue in the long-term extension phase.
4. Observed 6.5-fold reduction in abnormally expressed rejection-related gene sets after TFF TAC treatment.
5. No production of donor-specific antibodies (DSA) after TFF TAC treatment.

The company is finalizing the design for the next study in collaboration with clinical investigators and regulatory authorities, with updates expected later this fall.

TFF Pharmaceuticals (NASDAQ: TFFP), a clinical-stage biopharmaceutical company, has engaged Outcome Capital as a strategic advisor to evaluate corporate partnerships and licensing opportunities.

Dr. Harlan Weisman, CEO of TFF Pharmaceuticals, emphasized the commercial potential of their lead clinical assets, TFF VORI and TFF TAC. The collaboration aims to leverage Outcome Capital’s expertise in corporate advisory services within the life sciences industry.

Managing Partner of Outcome Capital, Oded Ben-Joseph, highlighted the impressive progress TFF Pharmaceuticals has made with their Thin Film Freezing (TFF) technology, and looks forward to identifying opportunities for TFF’s Phase 2 assets.

TFF Pharmaceuticals has announced a regulatory update for its Tacrolimus Inhalation Powder (TFF TAC) clinical program. Following a recent interaction, the FDA provided constructive feedback and guidance on the clinical development pathway.

The FDA agreed that mitigating or preventing tacrolimus-associated toxicities without risking lung allograft is a significant therapeutic benefit. TFF Pharmaceuticals does not anticipate any major changes to timelines or costs for TFF TAC's clinical advancement.

Dr. Zamaneh Mikhak, Chief Medical Officer, noted that additional guidance from the FDA is expected in the upcoming weeks, with a more detailed regulatory update to be provided in the third quarter of 2024.

TFF Pharmaceuticals and Leidos are advancing next-generation biodefense countermeasures under the DARPA PPB Program into preclinical testing.

These countermeasures, formulated using TFF's Thin Film Freezing (TFF) technology, have shown neutralizing activity against chemical and biological threats in vitro and ex vivo models.

The collaboration aims to protect military and healthcare personnel from future threats. The preclinical testing will be conducted at DARPA-contracted labs.

TFF's CEO Dr. Harlan Weisman highlighted the progress with Leidos and the potential of TFF technology to develop needle-free, temperature-independent solutions.