TFF

TFF Pharmaceuticals and Leidos to Advance Next-Generation Biodefense Countermeasures Under the DARPA PPB Program into Preclinical Testing

Retrieved on: 
Giovedì, Maggio 23, 2024
Military personnel, DARPA, Science, Leidos, Government, Engineering, Research, Face, PPB, TFF, Fortune 500, Microsoft, Temperature, Vaccine

FORT WORTH, Texas, May 23, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that the government will be advancing several next-generation medical countermeasures (MCMs) formulated with its Thin Film Freezing technology into advanced preclinical testing. TFF Pharmaceuticals is collaborating with Leidos, a leading Fortune 500 information technology, engineering and science solutions and services leader, to develop next-generation MCMs designed to protect military and healthcare personnel against future chemical and biological (CB) threats. The research is funded by the Defense Advanced Research Projects Agency (DARPA) under a contract through the Personalized Protective Biosystems (PPB) program.

Key Points: 
  • TFF Pharmaceuticals is collaborating with Leidos, a leading Fortune 500 information technology, engineering and science solutions and services leader, to develop next-generation MCMs designed to protect military and healthcare personnel against future chemical and biological (CB) threats.
  • The research is funded by the Defense Advanced Research Projects Agency (DARPA) under a contract through the Personalized Protective Biosystems (PPB) program.
  • The candidate MCMs delivered by Leidos to TFF Pharmaceuticals have been successfully formulated utilizing the Company’s proprietary Thin Film Freezing technology platform.
  • The MCMs are now progressing into in vivo preclinical testing, which will be conducted at DARPA-contracted laboratories.

TFF Pharmaceuticals and Cleveland Clinic to Advance Multivalent Universal Influenza Vaccine Candidates into Preclinical Testing

Retrieved on: 
Lunedì, Maggio 20, 2024
Antigen, Patient, Influenza, Infection, NIAID, PI, SBIR, IND, Cleveland Clinic, Vaccine, Congress, Nose, Research, Respiratory system, Direct, Viral, Death, TFF, CDC

The decision to advance the vaccine candidates into preclinical testing was based upon the successful completion of formulation testing with stability data on the combination of hemagglutinin (HA) antigens with four different adjuvants.

Key Points: 
  • The decision to advance the vaccine candidates into preclinical testing was based upon the successful completion of formulation testing with stability data on the combination of hemagglutinin (HA) antigens with four different adjuvants.
  • Based on these data, three HA antigen/adjuvant candidate vaccines have been selected for testing in a pre-clinical model at Cleveland Clinic Florida.
  • Successful completion of the work funded by the Direct to Phase II SBIR grant will fulfill the IND-enabling requirements to potentially advance to human clinical testing.
  • Influenza is a contagious viral infection that attacks the respiratory system, infecting the nose, throat and sometimes the lungs.

TFF Pharmaceuticals Provides Update on Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial for the Prevention of Lung Transplant Rejection

Retrieved on: 
Mercoledì, Maggio 15, 2024
Patient, Risk, Headache, Chronic kidney disease, Tacrolimus, Incidence, Kidney, TFF, Pharmaceutical industry

FORT WORTH, Texas, May 15, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today provided an update from the Company’s ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant rejection.

Key Points: 
  • “I am pleased to report that patient enrollment has accelerated due to positive physician enthusiasm based on emerging data, and we have now enrolled 10 patients in the TFF TAC Phase 2 study,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals.
  • “Furthermore, initial PK data from the first patient cohort indicate that dosing with TFF TAC results in less variability in the levels of systemic tacrolimus.
  • By reducing systemic tacrolimus trough and peak concentration swings through more targeted delivery, we believe TFF TAC has the potential to reduce the incidence of acute rejection and kidney toxicity, respectively.
  • In addition, we have received positive feedback on the ease of use of the TFF TAC inhalation device, which is a small portable inhaler that requires no priming or spacer, making it easy for patients to inhale drug and likely leading to improved compliance.”

TFF Pharmaceuticals Reports First Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Martedì, Maggio 14, 2024
Insurance, Principal, Patient, Research and development, Microsoft Access, EAP, FDA, International Society, Corporation, IPA, Voriconazole, Safety, Conference, Infection, Heart, AAAM, Mortality, TFF, Research, G&A, Administration, Lung transplantation, Pharmaceutical industry

FORT WORTH, Texas, May 14, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the first quarter 2024 and provided a corporate update.

Key Points: 
  • FORT WORTH, Texas, May 14, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the first quarter 2024 and provided a corporate update.
  • We expect to receive feedback from the FDA this quarter that will help guide our next steps in the clinical development pathway for TFF TAC.
  • I am also pleased to note that we were able to secure additional financing following the close of the quarter to help us further advance TFF TAC toward registrational testing.
  • The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

TFF Pharmaceuticals Announces Additional Positive Data from the Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial Following Oral Presentation at the ISHLT 44th Annual Late Breaking Clinical Science Abstract Sessions

Retrieved on: 
Lunedì, Aprile 15, 2024
International Society, Part, Kidney, Lung transplantation, Risk, Safety, Immunosuppression, IND, Tacrolimus, Patient, Principal, The Alfred Hospital, Lead, Lung, Gene expression, TFF, Annual general meeting, Gene

FORT WORTH, Texas, April 15, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced additional positive data from the ongoing Phase 2 study which is evaluating Tacrolimus Inhalation Powder (TFF TAC) for the prevention of organ rejection in lung transplant recipients. These new data were presented by Professor Gregory Snell, the lead Principal Investigator of the TFF TAC Phase 2 study, in an oral presentation at the International Society for Heart and Lung Transplantation (ISHLT) 44th Annual Meeting at a late breaking clinical science abstract session, on April 13, 2024, in Prague, Czech Republic.

Key Points: 
  • “The decreased expression of multiple, rejection-related genes provides compelling evidence at a molecular level that patients who have transitioned from oral tacrolimus onto TFF TAC are not experiencing rejection.
  • Part A of the trial is a 12-week treatment period, and Part B is an optional safety extension period.
  • In March 2024, the Company announced updated data from the first eight patients (N=8) enrolled in the trial.
  • Based on these highly encouraging results, TFF Pharmaceuticals plans to open an IND in the US to explore the use of TFF TAC early post-transplant in preparation for a registrational trial.

Shareholders of Puerto Rico Closed-End Fund Elect Ocean Capital Nominee and Support Terminating Management Agreements with UBS and Popular

Retrieved on: 
Martedì, Aprile 23, 2024
Professional Services, Finance, Participation, OCEAN, Capital, BLUE, Broadridge Financial Solutions, CARD, TFF, Annual general meeting

VOTE “FOR” OCEAN CAPITAL’S HIGHLY QUALIFIED DIRECTOR CANDIDATES ON THE BLUE PROXY CARD TODAY.

Key Points: 
  • VOTE “FOR” OCEAN CAPITAL’S HIGHLY QUALIFIED DIRECTOR CANDIDATES ON THE BLUE PROXY CARD TODAY.
  • VISIT WWW.IMPROVEUBSPRFUNDS.COM TO LEARN MORE ABOUT OCEAN CAPITAL’S CAMPAIGNS FOR VALUE-ENHANCING CHANGE AT THE FUNDS.
  • 2 Calculated by adding together the product of the number of days since each meeting and the number of nominees up for election at said meeting.
  • 3 The nine Funds include: Tax-Free Fixed Income Fund for Puerto Rico Residents, Inc. (“Fund I”), Tax-Free Fixed Income Fund II for Puerto Rico Residents, Inc. (“Fund II”), Tax-Free Fixed Income Fund III for Puerto Rico Residents, Inc. (“Fund III”), Tax-Free Fixed Income Fund IV for Puerto Rico Residents, Inc. (“Fund IV”), Tax-Free Fixed Income Fund V for Puerto Rico Residents, Inc. (“Fund V”), Puerto Rico Residents Tax-Free Fund, Inc. (“PRITF I”), Puerto Rico Residents Tax-Free Fund IV, Inc (“PRITF IV”), Puerto Rico Residents Tax-Free Fund VI, Inc. (“PRITF VI”) and Tax-Free Fund for Puerto Rico Residents (“TFF I”).

TFF Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Giovedì, Marzo 28, 2024
Research, TFF, Administration, Conference, Patient, IPA, EAP, Mortality, G&A, Lung transplantation, Insurance, AAAM, Microsoft Access, Research and development, Infection, Safety, FDA, Heart, Corporation, Pharmaceutical industry

FORT WORTH, Texas, March 28, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the fourth quarter and full year 2023.

Key Points: 
  • FORT WORTH, Texas, March 28, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the fourth quarter and full year 2023.
  • For TFF TAC, the Company presented data showing that eight out of eight patients successfully transitioned from oral Tacrolimus to TFF TAC in the Phase 2 study.
  • TFF TAC continues to demonstrate favorable safety results with no mortality or discontinuations due to adverse events.
  • In the fourth quarter 2023, the Company announced the appointment of three new members of its Board of Directors, including Thomas B.

TFF Pharmaceuticals Announces Updated Data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) Clinical Programs

Retrieved on: 
Mercoledì, Marzo 27, 2024
Principal, Annual, Fungal infection, TFF, COVID, Intubation, International Society, Part, Patient, Biomarker, IPA, Spirometry, EAP, Mortality, Lung transplantation, Microsoft Access, Potential, Safety, Kidney, Heart, Pharmaceutical industry

FORT WORTH, Texas , March 27, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced updated data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs.

Key Points: 
  • “Based on the totality of these clinical data, we believe TFF TAC and TFF VORI have the potential to establish a new and significantly improved form of delivery for these two life-saving medicines.
  • The updated safety and efficacy data are based on the cutoff date of March 8, 2024.
  • The ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity.
  • The Company will host a conference call today at 4:30 pm Eastern Time, to discuss updated data for the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs.

TFF Pharmaceuticals Announces Oral Presentation of Interim Data from the Phase 2 Study of Tacrolimus Inhalation Powder (TFF TAC) for the Prevention of Lung Transplant Rejection at the 44th Annual International Society for Heart and Lung Transplantation (I

Retrieved on: 
Lunedì, Marzo 25, 2024
TFF, Immunosuppression, Tacrolimus, Lung transplantation, Phase II, The Alfred Hospital, Heart, Lead, Pharmaceutical industry

FORT WORTH, Texas, March 25, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced the acceptance of its late-breaking clinical science abstract for oral presentation at the 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting, which will be held in Prague, Czech Republic from April 10-13, 2024.

Key Points: 
  • FORT WORTH, Texas, March 25, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced the acceptance of its late-breaking clinical science abstract for oral presentation at the 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting, which will be held in Prague, Czech Republic from April 10-13, 2024.
  • On January 9, 2024, the Company announced that the data from TFF TAC Phase 2 study was accepted as a late-breaking abstract.
  • “Results from the ongoing Phase 2 trial of TFF TAC continue to suggest that targeted, inhalational delivery of tacrolimus has the potential to provide sufficient immunosuppression to avoid acute rejection at diminished systemic exposures compared to oral tacrolimus” said Professor Gregory Snell, Medical Head of Lung Transplant Service at the Alfred Hospital and Lead Principal Investigator of the Phase 2 TFF TAC trial.
  • “Based on interim clinical data, TFF TAC appears to have the potential to provide a meaningful advancement in the delivery of immunosuppression therapy, and I look forward to presenting updated data from the Phase 2 trial at the upcoming ISHLT 2024 meeting.”
    Multicenter Open-Label Tacrolimus Inhalation Powder Trial Evaluating Safety, Tolerability, Efficacy and Pharmacokinetics (pk) in Lung Transplant (ltx)

TFF Pharmaceuticals Announces Closing of $1.2 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

Retrieved on: 
Venerdì, Marzo 22, 2024
TFF, 3rd Floor, Form, Sale, Security (finance), Prospectus, Regulation D

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

Key Points: 
  • H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
  • The gross proceeds to the Company from the offering were approximately $1.2 million before deducting placement agent fees and other offering expenses payable by the Company.
  • The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.
  • A final prospectus supplement and accompanying prospectus relating to the registered direct offering were filed with the SEC.