TFFP TFF Pharmaceuticals Inc - Ordinary Shares

8.29
-0.47  -5%
Previous Close 8.76
Open 8.78
52 Week Low 6.6
52 Week High 21.14
Market Cap $210,269,889
Shares 25,364,281
Float 23,899,011
Enterprise Value $164,135,979
Volume 154,440
Av. Daily Volume 190,814
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Upcoming Catalysts

Drug Stage Catalyst Date
Tacrolimus Inhalation Powder
Lung transplant (post)
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Voriconazole Inhalation Powder
Invasive Pulmonary Aspergillosis (IPA)
Phase 2
Phase 2
Phase 2 trial planned for 2H 2021.
Voriconazole Inhalation Powder
Asthma
Phase 1b
Phase 1b
Phase 1b trial initiation announced December 15, 2020.

Latest News

  1. Data Shows AUG-3387 Neutralizes SARS-CoV-2 Delta Variant in Infective Assays

    Supports Earlier Data Showing AUG-3387 Binds Strongly to Delta Variant in Addition to Wild-Type Spike Protein and Other Variants of Concern

    Catalent Selected as Contract Drug Manufacturing Organization (CDMO) for AUG-3387

    Scale-up Manufacturing for AUG-3387 Proceeding Rapidly; Early Batches Show Promising Results

    MENLO PARK, Calif. and AUSTIN, Texas, July 29, 2021 (GLOBE NEWSWIRE) -- Augmenta Bioworks, a biotechnology company enabling breakthroughs in medicine through immune profiling, and TFF Pharmaceuticals, Inc. (NASDAQ:TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented…

    Data Shows AUG-3387 Neutralizes SARS-CoV-2 Delta Variant in Infective Assays

    Supports Earlier Data Showing AUG-3387 Binds Strongly to Delta Variant in Addition to Wild-Type Spike Protein and Other Variants of Concern

    Catalent Selected as Contract Drug Manufacturing Organization (CDMO) for AUG-3387

    Scale-up Manufacturing for AUG-3387 Proceeding Rapidly; Early Batches Show Promising Results

    MENLO PARK, Calif. and AUSTIN, Texas, July 29, 2021 (GLOBE NEWSWIRE) -- Augmenta Bioworks, a biotechnology company enabling breakthroughs in medicine through immune profiling, and 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 positive in vitro data indicating that their lead anti-COVID-19 monoclonal antibody ("mAb") therapy, AUG-3387, binds to and neutralizes the SARS-CoV-2 Delta variant (B.1.617.2). The Delta variant is the current dominant strain of SARS-CoV-2 in the U.S., Europe and other geographic regions around the world.

    Recent data indicates that the Delta variant, which was recently declared a "Variant of Concern" by the World Health Organization, is more transmissible than the wild-type SARS-CoV-2 strain and other variants. The Delta variant now accounts for 83% of new cases in the U.S., according to recent CDC data. Demonstration that AUG-3387 effectively neutralizes the Delta variant in vitro is an encouraging step towards developing the therapy to slow and prevent ongoing spread of COVID-19.

    "We are very excited about these new data, which reinforce our view that AUG-3387 could represent an important new class of biologic-based treatment modalities that can effectively target the emerging and potentially more pathogenic variants of the SARS-CoV-2 virus," stated Dr. Christopher Emig, Chief Executive Officer of Augmenta Bioworks. "As global health officials look for innovative solutions to help curb human-to human spread of coronaviruses, we expect the treatment landscape for COVID-19 to evolve so that scalable, biologic-based therapies can play a more prominent role in efficiently combating viral transmission, particularly with respect to new, more infectious COVID-19 variants."

    Glenn Mattes, Chief Executive Officer of TFF Pharmaceuticals, added, "The rapid progress we are making with respect to generating positive in vitro data speaks to the enthusiasm both TFF and Augmenta have for evaluating the potential of AUG-3387 to combat all prevalent forms of the SARS-CoV-2 virus. Our collaboration also demonstrates how combining two highly innovative and complementary technology platforms can accelerate rapid advancements in drug development to address severe threats to global public health. We look forward to reporting further updates on the AUG-3387 program later this year."

    Augmenta and TFF Pharmaceuticals plan to develop AUG-3387 as an inhaled therapy for the treatment of COVID-19 disease in two types of individuals: (1) those already infected with SARS-CoV-2 who are at a high risk for severe disease but who have not yet been hospitalized, and (2) for the prevention of SARS-CoV-2 infection for individuals who are at a high risk for severe disease.

    The companies have selected a final formulation of AUG-3387 that will be used to complete in vivo preclinical efficacy studies in the coming weeks and will proceed with toxicology studies by the end of 2021. Ongoing formulation development studies are expected to demonstrate that a sufficient dose of AUG-3387 to achieve a neutralizing concentration in the lungs can be delivered via already approved commercial dry powder inhaler devices.

    In prior in vitro preclinical testing, AUG-3387 effectively neutralized SARS-CoV-2 and demonstrated activity against other major COVID variants of concern, including the previously identified Alpha variant (B.1.1.7), Beta variant (B.1.351), Gamma variant (P.1) and Kappa variant (B.1.617.1). The additional positive neutralization data against the delta variant reflects TFF and Augmenta's ongoing commitment to monitor activity of AUG-3387 against emerging SARS-CoV-2 variants, and to develop a therapy that is as effective as possible against currently dominant strains.

    TFF Pharmaceuticals and Augmenta also announced that Catalent Biologics has been selected to conduct cell line development utilizing their proprietary GPEx® platform and to lead drug substance manufacturing and scale-up efforts for AUG-3387 as the program advances through clinical development. Commenting on the agreement, Dr. Emig continued, "With AUG-3387 quickly emerging as a promising treatment against COVID-19, including for currently dominant variants, the selection of the CDMO is a critical decision along our development pathway. As one of the leading global providers of advanced biologics, Catalent brings exceptionally strong expertise in manufacturing of monoclonal antibodies. Augmenta and TFF look forward to working with them as the AUG-3387 program continues to advance."

    About the Development Agreement Between Augmenta Bioworks and TFF Pharmaceuticals

    In November 2020, Augmenta Bioworks and TFF Pharmaceuticals announced establishment of a worldwide Joint Development and Collaboration Agreement to develop novel commercial products incorporating Augmenta's human-derived monoclonal antibodies (mAbs) for potential COVID-19 therapeutics. TFF Pharmaceuticals also obtained the option to develop two additional Augmenta mAbs for indications other than COVID-19. These antibodies are expected to be developed utilizing TFF Pharmaceuticals' Thin Film Freezing technology to manufacture dry powder formulations for inhalation delivery directly to the lungs of patients. The Agreement also includes the development of formulations suitable for parenteral administration, where the Thin Film Freezing dry powder formulations can be reconstituted, potentially mitigating the impacts of cold-chain storage and handling. 

    About Augmenta Bioworks

    Augmenta Bioworks is a venture-backed biotechnology company leveraging immune profiling technologies to enable breakthroughs in medicine. Through its DeepGridTM and SingleCyteR Technologies, Augmenta profiles human immunity at unprecedented scale and speed, shrinking new drug discovery timelines from years to days. The company's platform utilizes the latest software, automation, microfluidics, high throughput DNA sequencing, and scalable computational analysis to identify immune receptors and their antigen specificity. The results are therapeutics derived from natural human immunity. The company works through partnerships in antibody discovery (infectious disease), cell therapy development (oncology), and other advanced research (auto-immunity).

    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 U.S. 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, its Joint Development and Collaboration Agreement with Augmenta Bioworks, TFF's and Augmenta's potential joint development of AUG-3387 to combat the SARS-CoV-2 virus and its variants and the parties' potential joint development of two additional Augmenta mAbs for indications other than COVID-19. 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 results obtained in dry powder formulation and in vitro testing of AUG-3387 and any other Augmenta mAbs may not be indicative of results obtained in future preclinical or clinical trials; (ii) the risk that TFF Pharmaceuticals' dry powder formulation of AUG-3387 and any other Augmenta mAbs may not advance through the preclinical development and clinical trial process on a timely basis, or at all; (iii) the risk that the results of such trials will not warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; (iv) the risk that TFF Pharmaceuticals and Augmenta may not be able to successfully conclude clinical testing or obtain pre-market approval of their dry powder versions of AUG-3387 or any other Augmenta mAbs, (v) the fact that no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) TFF Pharmaceuticals has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, and (vi) those other risks disclosed in the section "Risk Factors" included in the TFF Pharmaceuticals' 2020 Annual Report on Form 10-K filed with the SEC on March 10, 2021. 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.

    Company Contacts:

    Glenn Mattes

    President and CEO

    TFF Pharmaceuticals, Inc



    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.



    817-989-6358

    Christopher Emig, Ph.D.

    President and CEO

    Augmenta Bioworks, Inc



    650-731-2842

    Investor Relations Contact:

    Corey Davis, Ph.D.

    LifeSci Advisors

    212-915-2577

    Media Contact:

    Gwendolyn Schanker

    LifeSci Communications

    (269) 921-3607

    Source: TFF Pharmaceuticals, Inc.



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  2. AUSTIN, Texas, July 28, 2021 (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 its President and CEO, Glenn Mattes, will be available for one-on-one meetings and will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Monday, August 9, 2021 at 2:00pm EST.

    BTIG Virtual Biotechnology Conference – August 9-10, 2021

    If you are interested in arranging a one-on-one meeting, please contact your BTIG conference representative.

    Live Link:
    To listen to the live event, please contact your BTIG representative.

    About

    AUSTIN, Texas, July 28, 2021 (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 its President and CEO, Glenn Mattes, will be available for one-on-one meetings and will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Monday, August 9, 2021 at 2:00pm EST.

    BTIG Virtual Biotechnology Conference – August 9-10, 2021

    If you are interested in arranging a one-on-one meeting, please contact your BTIG conference representative.

    Live Link:

    To listen to the live event, please contact your BTIG representative.

    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.

    Company Contacts:

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.



    817-989-6358

    Investor Relations Contact:

    Corey Davis, Ph.D.

    LifeSci Advisors

    212-915-2577



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  3. Inhaled Tacrolimus Powder Achieves Systemic Therapeutic Drug Levels 
    Anticipate Additional Safety Data in 3Q 2021 
    Initiation of Lung Transplant Study Expected in 2H 2021

    AUSTIN, Texas, July 13, 2021 (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 the enrollment has been completed for the Phase 1 clinical trial for Tacrolimus Inhalation Powder ("inhaled tacrolimus").

    As discussed during our recent Science Day event, lung transplant patients receiving tacrolimus for maintenance immunosuppression are carefully monitored so that drug…

    Inhaled Tacrolimus Powder Achieves Systemic Therapeutic Drug Levels 

    Anticipate Additional Safety Data in 3Q 2021 

    Initiation of Lung Transplant Study Expected in 2H 2021

    AUSTIN, Texas, July 13, 2021 (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 the enrollment has been completed for the Phase 1 clinical trial for Tacrolimus Inhalation Powder ("inhaled tacrolimus").

    As discussed during our recent Science Day event, lung transplant patients receiving tacrolimus for maintenance immunosuppression are carefully monitored so that drug concentration levels can be adjusted to achieve efficacious immunosuppression while minimizing toxicities. Following lung transplant, therapeutic drug monitoring (TDM) is used to achieve maintenance tacrolimus blood levels from 5-15 ng/mL to prevent acute allograft rejection.

    In the Single Ascending Dose (SAD) phase of the trial, single doses of inhaled tacrolimus of 0.5 mg, 1.0 mg, 2.5 mg to 5.0 mg were administered to healthy subjects. Peak blood levels were measured 15 min after dosing, and trough blood levels were measured 12 hours after dosing for each subject. Peak levels were monitored to determine if they correlated with any acute adverse effects, while trough blood levels were measured to determine if subjects were reaching levels of tacrolimus that are sufficient for immunosuppression.

    In the subjects that received inhaled tacrolimus in the low dose group, the mean trough blood levels reached 1.1 ng/mL, while blood levels in the highest dose group reached 10.0 ng/mL. In addition, when subjects received inhaled tacrolimus dosing at 2.5 mg while fasting or 30 minutes after a high fat meal, there were no significant differences in systemic exposure demonstrating that delivery by inhalation was not associated with food effects in this cohort of subjects. By contrast, the rate and extent of absorption of tacrolimus is significantly decreased when tacrolimus is administered orally when taken with food, and this effect is most pronounced after a high-fat meal.

    Furthermore, during the Multiple Ascending Dose (MAD) phase, repeated dosing of inhaled tacrolimus every 12 hours over 7 days demonstrated that subjects receiving doses of 0.5 mg twice daily and 1.0 mg twice daily achieved 12-hour trough steady state blood levels that averaged 6.8 and 14.9 ng/mL, respectively. These data demonstrate that low dosing of Tacrolimus Inhalation Powder (0.5-1.0 mg) can achieve blood levels that are sufficient for efficacious immunosuppression.

    "Completion of enrollment in the Phase 1 study of Tacrolimus Inhalation Powder represents a critical milestone for TFF Pharmaceuticals, and the emerging data provide strong clinical evidence to support our thesis that inhaled tacrolimus can be effectively delivered to solid organ transplant patients with lower total doses than the oral forms of the drug due to our formulation's enhanced bioavailability and the lack of food effects," stated Glenn Mattes, the Chief Executive Officer of TFF Pharmaceuticals.

    TFF Pharmaceuticals expects to report topline safety data in the third quarter of 2021 and believes the strong bioavailability data will enable initiation of a clinical trial in lung transplant patients in the second half of 2021. TFF Pharmaceuticals expects that the dosing regimen for the study in lung transplantation will be tailored to potentially provide effective immunosuppression in the lung while reducing renal toxicities.

    In addition to leveraging its proprietary Thin Film Freezing technology platform to develop Inhaled Tacrolimus Power, TFF Pharmaceuticals is also developing two additional in-house programs: inhaled voriconazole for the treatment of pulmonary-based fungal infections, and inhaled niclosamide for the treatment of 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 Tacrolimus, 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 Tacrolimus, (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 10, 2021. 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.

    Company Contacts:

    Glenn Mattes

    President and CEO

    TFF Pharmaceuticals, Inc.



    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.



    817-989-6358

    Investor Relations Contact:  

    Corey Davis, Ph.D. 

    LifeSci Advisors 

    212-915-2577 



    Media Contact:

    Gwendolyn Schanker

    LifeSci Communications

    (269) 921-3607



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  4. MENLO PARK, Calif. and AUSTIN, Texas, June 22, 2021 (GLOBE NEWSWIRE) -- Augmenta Bioworks, a biotechnology company enabling breakthroughs in medicine through immune profiling, and 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 AUG-3387 has been selected as the first lead monoclonal antibody for clinical development against COVID-19 under their Joint Development and Collaboration Agreement. Targeting the SARS-Cov2 spike protein, AUG-3387 was isolated from an asymptomatic patient and then identified through Augmenta's platform in less than two weeks.

    MENLO PARK, Calif. and AUSTIN, Texas, June 22, 2021 (GLOBE NEWSWIRE) -- Augmenta Bioworks, a biotechnology company enabling breakthroughs in medicine through immune profiling, and 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 AUG-3387 has been selected as the first lead monoclonal antibody for clinical development against COVID-19 under their Joint Development and Collaboration Agreement. Targeting the SARS-Cov2 spike protein, AUG-3387 was isolated from an asymptomatic patient and then identified through Augmenta's platform in less than two weeks.

    Augmenta and TFF Pharmaceuticals plan to develop AUG-3387 as an inhaled therapy for the treatment of COVID-19 disease in two types of individuals: (1) those already infected with SARS-CoV2 who are at high risk for severe disease but who have not yet been hospitalized, and (2) for the prevention of SARS-CoV2 infection for individuals who are at high-risk for severe disease.

    Notably, in in vitro preclinical testing, AUG-3387 effectively neutralizes SARS-CoV2 and has demonstrated activity against all variant strains tested to date, including the major COVID variants of concern, including the previously identified UK (B.1.1.7 - Alpha), South African (B.1.351 - Beta), Brazil (P.1 - Gamma) and India (B.1.617.1 - Kappa) variants. TFF and Augmenta have an ongoing commitment to monitor activity of AUG-3387 against emerging SARS-CoV2 variants and will be completing in vivo preclinical efficacy studies in the coming weeks.

    "The activity of AUG-3387 against all SARS-CoV2 variants tested to date provides strong justification for the continued development of this unique monoclonal antibody therapy, especially when combined with the potential to break the cold chain requirement of other therapies and the cost-effective delivery of lower doses via inhalation, made possible through the TFF process," stated Dr. Christopher Emig, Chief Executive Officer of Augmenta Bioworks.

    "By combining the novel pan-variant activity of AUG-3387 with the enhanced stability and ease of delivery provided by the TFF technology, we believe this drug could potentially make significant impact on bringing COVID-19 disease under control where vaccines with extreme cold chain requirements are not feasible," added Glenn Mattes, Chief Executive Officer of TFF Pharmaceuticals. "We look forward to continued scale up manufacturing, completion of toxicology studies and enablement of human clinical trials in the coming months."

    In November 2020, the Companies announced establishment of a worldwide Joint Development and Collaboration Agreement to develop novel commercial products incorporating Augmenta's human-derived monoclonal antibodies (mAbs) for potential COVID-19 therapeutics. TFF Pharmaceuticals also obtained the option to develop two additional Augmenta mAbs for indications other than COVID-19. These antibodies will be developed utilizing TFF Pharmaceuticals' Thin-Film Freezing technology to manufacture dry powder formulations for inhalation delivery directly to the lungs of patients. The Agreement also includes the development of formulations suitable for parenteral administration, where the Thin Film Freezing dry powder formulations can be reconstituted, potentially mitigating the impacts of cold-chain storage and handling. 

    About Augmenta Bioworks

    Augmenta Bioworks is a venture-backed biotechnology company leveraging immune profiling technologies to enable breakthroughs in medicine. Through its patented DeepGridTM and SingleCyte® Technologies, Augmenta endeavors to profile human immunity at increased scale and speed, shrinking new drug discovery timelines. The company's platform utilizes the latest software, automation, microfluidics, high throughput DNA sequencing, and scalable computational analysis to identify immune receptors and their antigen specificity. The results are therapeutics derived from natural human immunity. The company works through partnerships in antibody discovery (infectious disease), cell therapy development (oncology), and other advanced research (auto-immunity).

    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 TFF platform and its dry powder versions of Voriconazole and Tacrolimus, the potential development of one or more dry powder mAbs through its collaboration with Augmenta Bioworks and the Company's plans to add to its existing pipeline of product candidates and license its technology to other third-parties. 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 results obtained in dry powder formulation and in vitro testing of the Augmenta mAbs may not be indicative of results obtained in future preclinical or clinical trials; (ii) the risk that TFF Pharmaceuticals' dry powder formulation of the Augmenta mAbs may not advance through the preclinical development and clinical trial process on a timely basis, or at all; (iii) the risk that the results of such trials will not warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; (iv) the risk that TFF Pharmaceuticals and Augmenta may not be able to successfully conclude clinical testing or obtain pre-market approval of their dry powder versions of the Augmenta mAbs, (v) the fact that no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) TFF Pharmaceuticals has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, and (vi) those other risks disclosed in the section "Risk Factors" included in the TFF Pharmaceuticals' 2020 Annual Report on Form 10-K filed with the SEC on March 10, 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.

    Company Contacts:

    Glenn Mattes

    President and CEO

    TFF Pharmaceuticals, Inc

                                                                                                  

    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.

                                                                                                  

    817-989-6358

    Christopher Emig, Ph.D.                                                                                                             

    President and CEO

    Augmenta Bioworks, Inc



    650-731-2842                                              

    Investor Relations Contact: 

    Corey Davis, Ph.D.         

    LifeSci Advisors         

    212-915-2577                 



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  5. Focus on TFF Tacrolimus for Lung Transplant and TFF in Vaccine Technology

    Tuesday, June 15th @ 4pm ET

    AUSTIN, Texas, June 07, 2021 (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 it will host a key opinion leader (KOL) perspectives webinar on thin film freezing applications, with a focus on TFF Tacrolimus for lung transplant and TFF approaches to improving vaccines. The webinar will be held on Tuesday, June 15, 2021 at 4:00pm Eastern Time.

    The webinar will feature presentations by KOLs Deborah Jo Levine, MD, UT Health San Antonio…

    Focus on TFF Tacrolimus for Lung Transplant and TFF in Vaccine Technology

    Tuesday, June 15th @ 4pm ET

    AUSTIN, Texas, June 07, 2021 (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 it will host a key opinion leader (KOL) perspectives webinar on thin film freezing applications, with a focus on TFF Tacrolimus for lung transplant and TFF approaches to improving vaccines. The webinar will be held on Tuesday, June 15, 2021 at 4:00pm Eastern Time.

    The webinar will feature presentations by KOLs Deborah Jo Levine, MD, UT Health San Antonio, Ted Ross, Ph.D., University of Georgia, and Kartik Chandran, Ph.D., Albert Einstein College of Medicine. Dr. Levine will provide background on lung transplantation, the current toxicity limitation of oral tacrolimus for immunosuppression, and the potential improvements with an inhaled formulation of tacrolimus (TFF TAC). Dr. Chandran will discuss the benefits of using the TFF technology to create a dry powder pulmonary formulation for the rVSV vaccine against COVID-19. Dr. Ross will discuss his experience utilizing the TFF process for creating a universal influenza vaccine for pulmonary delivery and its potential benefit over the existing annual vaccination.

    TFF Pharma's management team will also provide an update on its internal pipeline and several upcoming planned clinical data releases for TFF TAC and TFF voriconazole (treatment of invasive fungal infections).

    A live Q&A session will follow the formal presentations.

    You are required to register in advance for the webcast.

    Deborah Jo Levine, M.D. is Professor of Medicine in the Division of Pulmonary and Critical Care Medicine and Medical Director of Lung Transplantation, and Director of Pulmonary Hypertension Center with the UT Health San Antonio Long School of Medicine. Dr. Levine's research interests include antibody-mediated rejection in lung transplantation, infections in lung transplantation and new therapies in pulmonary hypertension. Her clinical work is focused mainly on lung transplantation, pulmonary hypertension, and end stage lung disease. She is boarded in pulmonary and critical care medicine. Dr. Levine received her B.S. in Physiology from the University of California, and a M.S. in Pharmacology and Toxicology and M.D. degree from the University of Arizona College of Medicine. She completed her Pulmonary and Critical Care Fellowship at University of Arizona and University of Texas and completed a fellowship in Lung Transplantation and interventional pulmonary.

    Ted M. Ross, Ph.D. is the Director of the Center for Vaccines and Immunology and Georgia Research Alliance Eminent Scholar and Professor of Infectious Diseases at the University of Georgia. Dr. Ross earned his undergraduate and graduate studies in Zoology and Microbiology at the University of Arkansas and he received a Doctorate in Microbiology and Immunology from Vanderbilt University in 1996. He was awarded the inaugural Sidney P. Colowick Award in Outstanding Graduate Research while at Vanderbilt. Dr. Ross performed post-doctoral fellowships at Duke University on HIV biology of viral entry and at Emory University on vaccine development for HIV and influenza viruses. He then started his own laboratory as Principal Investigator at East Carolina University and in 2003 moved the laboratory to the University of Pittsburgh in the Departments of Medicine-Infectious Diseases, Microbiology and Molecular Genetics, and as a founding member of the Center for Vaccine Research where he served the University for 10 years. In 2015, he joined the faculty at the University of Georgia. Dr. Ross explores new vaccine technologies intended to protect against all strains of influenza – an endeavor that could potentially eliminate the need for seasonal flu shots. Dr. Ross and his colleagues are applying similar strategies to fight other serious viruses such as, Dengue, SARS-CoV-2, Chikungunya, and HIV Type-1 viruses.

    Dr. Ross has published more than 225 papers and book chapters on infectious disease and vaccine development. He has been an invited speaker at more than 130 national and international conferences and participates in several vaccine working groups, including at the U.S. NIH, U.S. Centers for Disease Control and Prevention and the World Health Organization. He is an editorial 100 board member of Vaccine. He previously served as Editor-in-Chief of the journal Current HIV Research. In addition, he has been an ad-hoc reviewer on NIH study sections and a reviewer for 24 different journals.

    Dr. Ross is currently the President of International Society for Vaccines from 2020-2021 and has served as the Co-Chair of the ISV Congress in Philadelphia (8th), Seoul (9th), and Atlanta (12th).

    Kartik Chandran, Ph.D. is the Principle Investigator at The Chandran Lab, Professor of Medicine and Immunology, and The Harold and Muriel Block Faculty Scholar in Virology at the Albert Einstein School of Medicine. Dr. Chandran's research interests include emerging viruses, Ebola and Marburg viruses, bunyaviruses, hantaviruses, viral entry into cells, structure and function of viral fusion glycoproteins, virus-host interactions, viral genetics, and the development of novel antiviral therapeutics. More specifically, his work at The Chandran Lab focuses on understanding the complex relationship between virus and cell and developing novel antiviral treatments directed against filoviruses, such as Ebola virus and Marburg virus, and hantaviruses, such as Sin Nombre virus and Hantaan virus. Dr. Chandran and his colleagues frequently partner with academia, industry, and government also focus on translational research to accelerate the development of novel small molecule and antibody-based therapeutics that leverage the basic knowledge on viral invasion. Most recently, the Chandran Lab is developing research tools to discover and optimize therapeutics against COVID-19, and is also directly involved in the development of convalescent plasma and human monoclonal antibody-based therapeutics to prevent and treat COVID-19.

    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.

    Company Contacts:

    Glenn Mattes

    President and CEO

    TFF Pharmaceuticals, Inc

                                                                                                  

    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.

                                                                                                  

    817-989-6358

    Investor Relations Contact: 

    Corey Davis, Ph.D.         

    LifeSci Advisors         

    212-915-2577                 



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