TFF

TFF Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 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: 
Wednesday, March 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: 
Monday, March 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: 
Friday, March 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.

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

Retrieved on: 
Wednesday, March 20, 2024
TFF, 3rd Floor, Form, Sale, Security (finance), Prospectus, Regulation D

The closing of the offering is expected to occur on or about March 22, 2024, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The closing of the offering is expected to occur on or about March 22, 2024, subject to the satisfaction of customary closing conditions.
  • The gross proceeds to the Company from the offering are expected to be 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 will be filed with the SEC.

TFF Pharmaceuticals Announces Update on Clinical Programs

Retrieved on: 
Wednesday, March 20, 2024
Health, TFF, P-value, Acceleration, Partnership, Patient, IPA, EAP, KOL, Mortality, Clinical research associate, Microsoft Access, Calendar, Potential, Safety, Voriconazole, Pharmaceutical industry

FORT WORTH, Texas, March 20, 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, is announcing data updates and strategic prioritization of its clinical programs. Based on positive data from the ongoing Phase 2 study of TFF TAC, the potential to address a significant unmet need in lung transplant medicine, and substantial market opportunity, the Company has made the decision to prioritize the TFF TAC program and focus resources on the acceleration of its clinical pathway towards registration.

Key Points: 
  • “However, after a rigorous assessment of our pipeline, including the significant capital and resources required to progress both clinical development programs, we will focus our clinical development efforts and financial resources on TFF TAC.
  • In summary, for TFF TAC, eight out of eight patients have 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.
  • The Company will host a conference call on Wednesday, March 27, 2024, at 4:30 PM Eastern Time, to discuss updated clinical data for the TFF TAC and TFF VORI.

TFF Pharmaceuticals to Participate in the 36th Annual Roth Conference – March 17-19, 2024

Retrieved on: 
Thursday, March 14, 2024
TFF, Conference

FORT WORTH, Texas, March 14, 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 that Harlan Weisman, M.D., Chief Executive Officer of TFF Pharmaceuticals will be presenting a corporate overview at the 36th Annual Roth Conference being held March 17-19, 2024 in Dana Point, California.

Key Points: 
  • FORT WORTH, Texas, March 14, 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 that Harlan Weisman, M.D., Chief Executive Officer of TFF Pharmaceuticals will be presenting a corporate overview at the 36th Annual Roth Conference being held March 17-19, 2024 in Dana Point, California.
  • Company management will also be participating in one-on-one meetings.
  • 36th Annual Roth Conference – March 17-19, 2024

Syngene biologics manufacturing facility to be operational for US and European customers from mid-year

Retrieved on: 
Thursday, March 14, 2024
Bioreactor, Control, TFF, Growth, PROTAC, LPH, DCAT, CGMP, CMC, EMA, Spacecraft, MD, Senior, Quality assurance, US FDA, Unit, Biocon, Perfusion, Fine chemical

BANGALORE, India, March 14, 2024 /PRNewswire/ -- At DCAT 2024 global bio/pharmaceutical manufacturing forum, Syngene International, a global contract research, development and manufacturing organization (CRDMO), will announce that its newly upgraded biologics facility - Unit 3 - would be operational for clinical and commercial supply in the second half of 2024.

Key Points: 
  • The facility will be available for biotech and pharma customers seeking drug substance and drug product contract manufacturing.
  • The Company also has a microbial cGMP facility and a mammalian cell manufacturing facility to extend end-to-end Chemistry, Manufacturing and Control (CMC) development solutions for its global clients.
  • The integration of chromatography systems streamlines the purification processes and enhances the overall efficiency of biologics manufacturing.
  • In total Unit 3 will have around 100 staff for Quality Assurance and Manufacturing, part of Syngene's 600-strong team across its biologics manufacturing services and supporting specialist functions.

Syngene biologics manufacturing facility to be operational for US and European customers from mid-year

Retrieved on: 
Thursday, March 14, 2024
Bioreactor, Control, TFF, Growth, PROTAC, LPH, DCAT, CGMP, CMC, EMA, Spacecraft, MD, Senior, Quality assurance, US FDA, Unit, Biocon, Perfusion, Fine chemical

BANGALORE, India, March 14, 2024 /PRNewswire/ -- At DCAT 2024 global bio/pharmaceutical manufacturing forum, Syngene International, a global contract research, development and manufacturing organization (CRDMO), will announce that its newly upgraded biologics facility - Unit 3 - would be operational for clinical and commercial supply in the second half of 2024.

Key Points: 
  • The facility will be available for biotech and pharma customers seeking drug substance and drug product contract manufacturing.
  • The Company also has a microbial cGMP facility and a mammalian cell manufacturing facility to extend end-to-end Chemistry, Manufacturing and Control (CMC) development solutions for its global clients.
  • The integration of chromatography systems streamlines the purification processes and enhances the overall efficiency of biologics manufacturing.
  • In total Unit 3 will have around 100 staff for Quality Assurance and Manufacturing, part of Syngene's 600-strong team across its biologics manufacturing services and supporting specialist functions.

Repligen Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, February 21, 2024
Acquisition, Filtration, Ultrafiltration, Growth, Loss, ESG, Cross-flow filtration, GAAP, Net, TFF, Repligen

WALTHAM, Mass., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, today reported financial results for its fourth quarter of 2023, covering the three- and twelve-month periods ended December 31, 2023.

Key Points: 
  • WALTHAM, Mass., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, today reported financial results for its fourth quarter of 2023, covering the three- and twelve-month periods ended December 31, 2023.
  • We are pleased to report that for the second quarter in a row, our book-to-bill ratio was above 1.0, at 1.03 for the fourth quarter.
  • Base revenue (non-GAAP) for Q4 2023 was $142.1 million, compared to $163.0 million for Q4 2022.
  • For Q4 2023, net loss (GAAP) was ($25.5) million, compared to net income (GAAP) of $48.7 million for Q4 2022.