TFFP TFF Pharmaceuticals Inc - Ordinary Shares

14.61
+0.1  (+1%)
Previous Close 14.51
Open 14.56
52 Week Low 3.44
52 Week High 21.14
Market Cap $324,726,009
Shares 22,226,284
Float 16,686,736
Enterprise Value $274,439,867
Volume 167,271
Av. Daily Volume 351,561
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
Voriconazole Inhalation Powder
Asthma
Phase 1b
Phase 1b
Phase 1b trial initiation announced December 15, 2020.
Tacrolimus Inhalation Powder
Prophylaxis of lung allograft rejection
Phase 1
Phase 1
Phase 1 completion of SAD dosing announced October 20, 2020.
Voriconazole Inhalation Powder
Invasive Pulmonary Aspergillosis (IPA)
Phase 1
Phase 1
Phase 1 data released September 15, 2020. Phase 2 trial planned.

Latest News

  1. Company conference call and webcast at 4:30 PM ET

    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 it will release its financial results for the fourth quarter and full-year 2020 and business update on Wednesday, March 10, 2021 at the close of the U.S. financial markets.

    Management will host a conference call to discuss the financial results and provide an update on recent corporate and clinical developments at 4:30 PM Eastern Time. A question-and-answer session with investors will follow management's remarks.

    Conference Call Details:

    Wednesday, March…

    Company conference call and webcast at 4:30 PM ET

    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 it will release its financial results for the fourth quarter and full-year 2020 and business update on Wednesday, March 10, 2021 at the close of the U.S. financial markets.

    Management will host a conference call to discuss the financial results and provide an update on recent corporate and clinical developments at 4:30 PM Eastern Time. A question-and-answer session with investors will follow management's remarks.

    Conference Call Details:

    Wednesday, March 10, 2021, 4:30 PM Eastern Time (ET)

    Domestic Dial-In Number: Toll-Free: (877) 784-1702

    International Dial-In Number (857) 770-0110

    Conference ID: 9195779

    Webcast Registration Link: https://edge.media-server.com/mmc/p/ev6cv5ub

    Please access the Webcast Registration Link at least 15 minutes ahead of the Conference to register, download, and install any necessary audio software.

    The conference call will also be available for replay for one month on the Company's website, https://tffpharma.com, in the Events Calendar of the Investors section.

    About TFF Pharmaceuticals' Thin Film Freezing technology platform

    TFF Pharmaceuticals' Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a "Brittle Matrix Particle," which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments, the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.

    About TFF Pharmaceuticals

    TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 42 patents issued or pending in the US and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company's website at https://tffpharma.com.

    View Full Article Hide Full Article
  2. Company's Thin Film Freezing maintained efficacy for two different biodefense countermeasures against Alphaviruses and Filoviruses

    TFF Pharmaceuticals, Inc. (NASDAQ:TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented thin-film freeze-drying (TFFD) technology platform, today announced that, in collaboration with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), the Company obtained positive preclinical in vitro efficacy data from TFF formulated biodefense countermeasures.

    In April of 2020, TFF Pharmaceuticals and USAMRIID, part of the U.S. Army Medical Research and Development Command, the U.S. Army's premier institution…

    Company's Thin Film Freezing maintained efficacy for two different biodefense countermeasures against Alphaviruses and Filoviruses

    TFF Pharmaceuticals, Inc. (NASDAQ:TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented thin-film freeze-drying (TFFD) technology platform, today announced that, in collaboration with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), the Company obtained positive preclinical in vitro efficacy data from TFF formulated biodefense countermeasures.

    In April of 2020, TFF Pharmaceuticals and USAMRIID, part of the U.S. Army Medical Research and Development Command, the U.S. Army's premier institution and facility for defensive research into countermeasures against biological warfare, entered into a 3-year Cooperative Research and Development Agreement (CRADA) to investigate TFFD of various biodefense countermeasures to demonstrate the use of these formulations as needle-free, inhaled treatments that are temperature-insensitive. The first two countermeasures, a monoclonal antibody (mAbs) against Ebolavirus Zaire (EBOV) and a recombinant vesicular stomatitis virus (rVSV) vaccine candidate against Venezuelan equine encephalitis virus (VEEV), were TFFD formulated and tested for efficacy in a well-established in vitro neutralization assay. Data showed that the activity of the mAbs and rVSV vaccines were preserved after TFFD. Formulation optimization and long-term stability testing are ongoing. Next steps will be in vivo testing in appropriate animal models.

    "This data utilizing our TFFD technology to reformulate currently developed and characterized medical countermeasures against EBOV and VEEV is an important milestone," said Glenn Mattes, CEO of TFF Pharmaceuticals. "Most countermeasures are parenterally delivered, require trained personnel for administration and are temperature sensitive. There is an urgent need to develop technologies to improve biodefense countermeasures to better protect the warfighter."

    "Great strides have been made to develop licensed countermeasures against Department of Defense (DoD) select agents of interest, such as Ebolavirus Zaire (EBOV) and Venezuelan equine encephalitis (VEEV)," said John M. Dye, Jr., Viral Immunology branch chief, USAMRIID. "An alternate route of administration that bypasses the need for cold chain control and administration by specialized personnel could be critical in the protection of our defense forces in biologically hostile environments around the globe."

    TFF continues to engage and collaborate with various government and defense contracting agencies in an effort to utilize the Company's TFFD technology platform to formulate dry powder vaccines and therapeutics for delivery via reconstitution, or for lung or nasal inhalation.

    About the U.S. Army Medical Research Institute of Infectious Diseases:

    For over 50 years, USAMRIID has provided leading edge medical capabilities to deter and defend against current and emerging biological threat agents. The Institute is the only laboratory in the Department of Defense equipped to safely study highly hazardous viruses requiring maximum containment at Biosafety Level 4. Research conducted at USAMRIID leads to medical solutions – vaccines, drugs, diagnostics, information, and training programs – that benefit both military personnel and civilians. Established in 1969, the Institute plays a key role as the lead military medical research laboratory for the Defense Threat Reduction Agency's Joint Science and Technology Office for Chemical and Biological Defense. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Development Command. For more information, visit www.usamriid.army.mil. The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.

    About TFF Pharmaceuticals' Thin Film Freezing technology platform

    TFF Pharmaceuticals' Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a "Brittle Matrix Particle," which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments, the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.

    About TFF Pharmaceuticals

    TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 42 patents issued or pending in the US and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company's website at https://tffpharma.com

    SAFE HARBOR

    This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company's TFFD platform and its dry powder versions of voriconazole and the Company's plans to add to its existing pipeline of product candidates. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the Company may not be able to successfully conclude preclinical testing of its EBOV mAbs or rVSV vaccine or obtain pre-market approval of either product candidate, (ii) no drug product incorporating the TFFD platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFFD Platform, (iv) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (v) those other risks disclosed in the section "Risk Factors" included in the Company's prospectus supplement filed with the SEC on December 8, 2020. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.

    View Full Article Hide Full Article
  3. 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, will participate in the 2021 BIO CEO & Investor Digital Conference, being held virtually on February 16-18, 2021.

    Glenn Mattes, President & CEO of TFF Pharmaceuticals, is scheduled to give a pre-recorded company presentation at the conference. The recording will be available on-demand to registered conference attendees via the BIO conference portal for 30 days and can be accessed in the Investor Relations section of the TFF Pharmaceuticals website.

    The Company will also participate in investor and partnering meetings with conference…

    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, will participate in the 2021 BIO CEO & Investor Digital Conference, being held virtually on February 16-18, 2021.

    Glenn Mattes, President & CEO of TFF Pharmaceuticals, is scheduled to give a pre-recorded company presentation at the conference. The recording will be available on-demand to registered conference attendees via the BIO conference portal for 30 days and can be accessed in the Investor Relations section of the TFF Pharmaceuticals website.

    The Company will also participate in investor and partnering meetings with conference attendees during the event.

    About TFF Pharmaceuticals' Thin Film Freezing technology platform

    TFF Pharmaceuticals' Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a "Brittle Matrix Particle," which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.

    About TFF Pharmaceuticals

    TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 42 patents issued or pending in the US and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company's website at https://tffpharma.com.

    View Full Article Hide Full Article
  4. Corporate presentation available on demand beginning Monday, January 11, 2021 at 6:00 AM ET

    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, has been invited to present at H.C. Wainwright's BioConnect 2021 Conference, being held virtually on January 11-14, 2021.

    Glenn Mattes, President & CEO of TFF Pharmaceuticals, is scheduled to give a pre-recorded company presentation to conference attendees. The recording will be available on-demand via the H.C. Wainwright conference portal for one week and can be accessed in the Investor Relations section at TFF Pharmaceuticals beginning…

    Corporate presentation available on demand beginning Monday, January 11, 2021 at 6:00 AM ET

    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, has been invited to present at H.C. Wainwright's BioConnect 2021 Conference, being held virtually on January 11-14, 2021.

    Glenn Mattes, President & CEO of TFF Pharmaceuticals, is scheduled to give a pre-recorded company presentation to conference attendees. The recording will be available on-demand via the H.C. Wainwright conference portal for one week and can be accessed in the Investor Relations section at TFF Pharmaceuticals beginning on Monday, January 11 at 6:00 AM Eastern time.

    In addition, the Company will meet with investors at the Biotech Showcase, an event also taking place virtually from January 11-15, as well as participating in investor and partnering meetings through the Biotechnology Innovation Organization's (BIO) One-on-One Partnering System throughout the week.

    About TFF Pharmaceuticals' Thin Film Freezing technology platform

    TFF Pharmaceuticals' Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a "Brittle Matrix Particle," which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.

    About TFF Pharmaceuticals

    TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 42 patents issued or pending in the US and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company's website at https://tffpharma.com.

    View Full Article Hide Full Article
  5. Phase 1b Dosing of Voriconazole Inhalation Powder in asthma patients to evaluate safe dosing in patients with hyperreactive airways for direct-to-lung delivery of voriconazole for the treatment or prevention of Invasive Pulmonary Aspergillosis (IPA)

    Asthma patients with hyperreactive airways represent a large proportion of patients with IPA

    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 dosing of the first subjects in its Phase 1b clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of voriconazole…

    Phase 1b Dosing of Voriconazole Inhalation Powder in asthma patients to evaluate safe dosing in patients with hyperreactive airways for direct-to-lung delivery of voriconazole for the treatment or prevention of Invasive Pulmonary Aspergillosis (IPA)

    Asthma patients with hyperreactive airways represent a large proportion of patients with IPA

    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 dosing of the first subjects in its Phase 1b clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of voriconazole (NCT #04576325), which is generally considered to be the most effective antifungal drug for treatment of Aspergillosis infections.

    Patients with asthma, and a portion of patients with Cystic Fibrosis and Chronic Obstructive Pulmonary Disease (COPD), have hyperreactive airways where bronchoconstriction can be triggered following administration of drugs by inhalation. These patient populations are also susceptible to Invasive Pulmonary Aspergillosis infections due to impaired mucociliary clearance, which allows aspergillus spores to become trapped and grow in mucus that builds up in their lungs.

    TFF Pharmaceuticals is conducting this Phase 1b clinical trial of Voriconazole Inhalation Powder in patients with asthma to assess the safety, pharmacokinetics, and induction of bronchospasm. Drugs for treatment of pulmonary infections can be associated with induction of bronchospasm and require bronchodilator pretreatment for safe administration. Treatment of Voriconazole Inhalation Powder without induction of bronchospasm would allow for treatment of patients with IPA that have hyperreactive airway disease comorbidities to proceed without bronchodilator pretreatment.

    "The treatment of asthma patients in this study will test the safety and pharmacokinetics in patients with airway hyperresponsiveness, and will expand the potential patient population to help speed enrollment in our pivotal trials for the treatment of IPA with Voriconazole Inhalation Powder," stated Glenn Mattes, President and CEO of TFF Pharmaceuticals. "This study will also help us determine if there are differences in drug uptake in patients with compromised lungs, compared to healthy subjects."

    TFF Pharmaceuticals is advancing development of Voriconazole Inhalation Powder towards a pivotal Phase 2 study to assess the efficacy of the dry powder formulation for the treatment of IPA. Previously, TFF reported that repeated dosing of Voriconazole Inhalation Powder twice daily for 7 days in healthy normal volunteers was well tolerated at doses up to 80 mg with no clinically significant adverse findings, including changes in pulmonary function. The current study is designed to assess the safety and tolerability of 40 and 80 mg doses in asthma patients with hyperreactive airways. Administration of the inhaled voriconazole to IPA patients at 40 mg doses was previously reported to be well tolerated.

    Voriconazole is recommended as the first line treatment for IPA according to the Infectious Disease Society (IDSA) - Practice Guidelines for the Diagnosis and Management of Aspergillosis (2016), but voriconazole is associated with significant drug-drug interactions and toxicities. Delivery of voriconazole directly to the lung may allow for a product that has greater efficacy than orally administered voriconazole and that has improved safety through reduced systemic toxicities and reduced drug-drug interactions.

    TFF Pharmaceuticals' proprietary Thin Film Freezing technology platform allows the reformulation of voriconazole into dry powder particles with properties believed to be ideally suited for inhalation delivery. In addition to voriconazole, TFF is also developing dry powder formulations of tacrolimus to prevent lung transplant rejection and niclosamide to treat COVID-19 (SARS-CoV2) infections.

    About TFF Pharmaceuticals' Thin Film Freezing technology platform

    TFF Pharmaceuticals' Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a "Brittle Matrix Particle," which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.

    About TFF Pharmaceuticals

    TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 42 patents issued or pending in the US and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company's website at https://tffpharma.com.

    SAFE HARBOR

    This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company's TFF platform and its dry powder versions of voriconazole and the Company's plans to add to its existing pipeline of product candidates. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its dry powder versions of voriconazole, (ii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (iv) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (v) those other risks disclosed in the section "Risk Factors" included in the Company's 2019 Annual Report on Form 10-K filed with the SEC on March 26, 2020. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.

    View Full Article Hide Full Article
View All TFF Pharmaceuticals Inc - Ordinary Shares News