1. AUSTIN, Texas, Sept. 08, 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 President and CEO Glenn Mattes will present a corporate overview at 23rd H.C. Wainwright Annual Global Investment Conference being held from September 13-15th, 2021.

    Details on the presentation can be found below:

    Presentation date: available on-demand starting at 7:00 a.m. ET on September 13, 2021

    Webcast link: https://journey.ct.events/view/4a77d813-2d0d-4ffe-9b6d-920b5962e6e5

    About TFF Pharmaceuticals 
    TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical…

    AUSTIN, Texas, Sept. 08, 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 President and CEO Glenn Mattes will present a corporate overview at 23rd H.C. Wainwright Annual Global Investment Conference being held from September 13-15th, 2021.

    Details on the presentation can be found below:

    Presentation date: available on-demand starting at 7:00 a.m. ET on September 13, 2021

    Webcast link: https://journey.ct.events/view/4a77d813-2d0d-4ffe-9b6d-920b5962e6e5

    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 58 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

    gmattes@tffpharma.com                                                                                      

    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.

    kcoleman@tffpharma.com                                                                                  

    817-989-6358

    Investor Relations Contact:  

    Corey Davis, Ph.D. 

    LifeSci Advisors 

    212-915-2577 

    cdavis@lifesciadvisors.com  

    Media Contact:

    Gwendolyn Schanker

    LifeSci Communications

    269-921-3607

    gschanker@lifescicomms.com 

    Source: TFF Pharmaceuticals, Inc.



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  2. Additional Data Readouts and Initiation of Pivotal Trials for Inhaled Tacrolimus and Voriconazole Programs Expected in 2H 2021

    Multiple Ascending Dose (MAD) Study Demonstrates Inhaled Tacrolimus Inhalation Powder Achieves Blood Levels Sufficient for Efficacious Immunosuppression

    Formation of Scientific Advisory Board to Enable Continued Innovation and Clinical Development

    Partnerships with Pharma, Academic Institutions and Government Continue to Advance

    Conference Call and Webcast Scheduled Today, Thursday, August 12, 2021, at 4:30pm EDT

    AUSTIN, Texas, Aug. 12, 2021 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ:TFFP), a clinical-stage biopharmaceutical…

    Additional Data Readouts and Initiation of Pivotal Trials for Inhaled Tacrolimus and Voriconazole Programs Expected in 2H 2021

    Multiple Ascending Dose (MAD) Study Demonstrates Inhaled Tacrolimus Inhalation Powder Achieves Blood Levels Sufficient for Efficacious Immunosuppression

    Formation of Scientific Advisory Board to Enable Continued Innovation and Clinical Development

    Partnerships with Pharma, Academic Institutions and Government Continue to Advance

    Conference Call and Webcast Scheduled Today, Thursday, August 12, 2021, at 4:30pm EDT

    AUSTIN, Texas, Aug. 12, 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 reported financial results for the second quarter ended June 30, 2021, and also provided an update on recent corporate and clinical developments. The Company will discuss the clinical, corporate and financial highlights on a conference call and webcast, scheduled today, Thursday, August 12, 2021, at 4:30pm EDT.

    "As we advance both our internal programs and external partnerships, TFF Pharmaceuticals continues to demonstrate the transformative potential of our proprietary Thin Film Freezing (TFF) drug delivery platform to improve upon pharmacokinetic and clinical profiles of currently approved therapies, while also formulating novel small molecule and biologic-based therapeutics that address serious unmet medical need," said Glenn Mattes, President and CEO of TFF Pharmaceuticals.

    "During this quarter, we announced data from a multiple ascending dosing study showing that our Inhaled Tacrolimus Powder has superior bioavailability as compared to the oral dosage form of tacrolimus, and that relatively low doses as compared to the oral dosage form were able to generate blood concentration levels of tacrolimus known to be sufficiently immunosuppressive in preventing organ rejection following lung transplants. Our toxicology studies demonstrated that the lung concentrations are three- to four-fold higher than blood concentrations and together these data suggest that we can achieve sufficient drug levels in the lung to prevent rejection, while at the same time, mitigating the potential for renal toxicity. We believe this improved pharmacokinetic profile could result in superior safety compared to the oral product without sacrificing efficacy."

    Mr. Mattes continued, "I am also pleased to report that our internal CMC and drug manufacturing projects remain on track to fully support our product supply needs for our planned pivotal trials for Inhaled Voriconazole Powder and Inhaled Tacrolimus Powder. Our TFF-TAC program represents a potential significant advancement in a field that has seen very little innovation in decades, and we look forward to presenting additional data for this program later in the year."

    "We are also excited to announce significant advances on the partnering front. Most recently, TFF and its partner, Augmenta Bioworks, announced the selection of a lead monoclonal antibody, AUG-3387, which is being developed for the prevention and treatment of COVID-19 and, importantly, has been shown to effectively neutralize the Delta variant in in vitro studies. The relationship with Augmenta is a prime example of how our Company's Thin Film Freezing technology can be applied to proprietary, biologic-based therapeutics addressing a large unmet medical need in public health. This remains a highly active area of collaboration and partnerships for our company, as we now have in place several programs focused on the application of our TFF technology to biologic drugs."

    Importantly, all of our pharmaceutical company partnerships continue to advance, which include collaborations with Union Therapeutics Felix Therapeutics, GreenLight Biosciences, NeuroRx, PLUS Products, and Felix Biotechnology. In addition, we currently have ongoing projects with the majority of the top 20 pharmaceutical companies, where we are applying our thin film freezing technology to their products, and in some cases, working on multiple product formulation opportunities for individual companies. In addition, our academic and government partnerships and contracts are progressing and producing meaningful new data."

    "Results in the second half should further advance preclinical and clinical progress on both internal and partnered programs as well as generate material new business development opportunities. We believe these anticipated results will reinforce the applicability of TFF's proprietary technology for the use in improving human health across a number of therapeutic areas."

    He continued, "As a result of our continued progress across these programs, we have also made key leadership appointments to support both our manufacturing operations and the expansion of our government/academic institution partnership team.

    "I am also delighted to announce the formation of TFF's Scientific Advisory Board, a group of extraordinarily accomplished individuals who will impart a wealth of invaluable scientific and medical expertise as we accelerate multiple programs from early-stage development to advanced clinical testing, both for our proprietary drug programs and our partnered opportunities.

    "In the second half of the year, TFF will build on these significant accomplishments as we move our internal programs into pivotal testing. On the business development front, we expect to advance our programs with existing partners, while signing new licensing transactions with pharmaceutical and biotechnology companies."   

    Conference Call and Webcast Information

    The Company will host a conference call today, Thursday, August 12, 2021, at 4:30 pm, Eastern Daylight Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

    Domestic Dial-In Number: Toll-Free: (866) 269-4261

    International Dial-In Number (323) 289-6581

    Conference ID: 6229028

    The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals' Website, https://tffpharma.com or directly at http://public.viavid.com/index.php?id=146022. Please access the Company's website 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 in the Events Calendar of the Investors section.

    Recent Clinical and Corporate Highlights: 

    • Voriconazole Inhalation Powder (TFF VORI): As noted on the first quarter update, TFF has successfully completed the first of two dosing cohorts in a Phase 1b reactive airway study, which is evaluating safe dosing of TFF VORI in asthma patients with hyperreactive airways. The safety profile for TFF VORI continues to look favorable, with no serious adverse events reported in these cohorts. Top-line data from the study is expected in the third quarter of 2021. The Company continues preparations for an end of Phase 1 meeting with the FDA, and anticipates this meeting will also be held in the third quarter, after the dosing in this Phase 1b reactive airway study is complete.



      Earlier in the year, TFF announced the successful completion of the Phase 1 clinical trial and final data for Voriconazole Inhalation Powder for the treatment of invasive pulmonary aspergillosis (IPA). Based on the results of the Phase 1 trial, the Company will study the 80 mg dose of Voriconazole Inhalation Powder for the upcoming pivotal trial where it will be compared to the oral form of voriconazole. The Company expects to initiate a pivotal trial of TFF VORI in the fourth quarter of 2021, which will be designed to assess efficacy for treating patients with IPA or for preventing infection in patients at high risk for developing IPA infections.
    • Tacrolimus Inhalation Powder (TFF TAC)In July, the Company announced completion of enrollment and preliminary data from its Phase 1 trial of Tacrolimus Inhalation Powder (TFF TAC). 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. 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. Following lung transplant, it is desirable for patients to achieve maintenance tacrolimus blood levels from 5-15 ng/mL to prevent acute allograft rejection.



      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.



      In 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. Importantly, these data demonstrate that low dosing of Tacrolimus Inhalation Powder (0.5-1.0 mg) can achieve blood levels that are believed to be sufficient for efficacious immunosuppression.



      TFF Pharmaceuticals expects to report top-line 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. The Company 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 June, TFF Pharma held a Science Day for investors, featuring key opinion leader (KOL) perspectives on Thin Film Freezing applications, with a focus on TFF Tacrolimus for lung transplant and TFF approaches to improving vaccines. Deborah Jo Levine, M.D., from UT Health San Antonio, provided 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). Kartik Chandran, Ph.D., from the Albert Einstein College of Medicine, discussed the benefits of using the TFF technology to create a dry powder pulmonary formulation for the rVSV vaccine against COVID-19. Ted Ross, Ph.D., from the University of Georgia, discussed 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 also provided an update on its internal pipeline and several upcoming planned clinical data releases for TFF TAC and TFF VORI (treatment of invasive fungal infections). The event and its presentation materials can be found on the TFF corporate website.
    • Strategic Business Development and Partnership Activities – Governmental and Defense Contracting Agencies: Early in the second quarter, TFF announced that it is was awarded a contract with Leidos to participate in the Personalized Protective Biosystems (PPB) Program to develop next-generation chemical and biological protection for U.S. warfighters and stability operators. The PPB research program is overseen by the Defense Advanced Research Projects Agency (DARPA) and aims to develop an integrated system that simultaneously reduces protective equipment needs while increasing protection for the individual against existing and future chemical and biological (CB) threats. TFF Pharmaceuticals will utilize its Thin Film Freezing platform to formulate a series of countermeasures designed to neutralize chemical and biological agents at the site of vulnerable tissue barriers, including the skin, eyes and respiratory system.



      We continue to engage and collaborate with various government and defense contracting agencies in an effort to utilize the Company's TFF technology platform to formulate dry powder vaccines and therapeutics for delivery via reconstitution for lung or nasal inhalation. This includes our 3-year Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) for biodefense countermeasures, and our early-stage universal influenza work with the University of Georgia's Center for Vaccines and Immunology, part of the NIH's Collaborative Influenza Vaccine Innovation Centers (CIVICs).
    • Strategic Business Development and Partnership Activities – Biopharmaceutical Companies and Research Institutions, Cannabis Development and Commercialization: During the second quarter, TFF Pharmaceuticals and its partner, Augmenta Bioworks, selected a lead monoclonal antibody candidate, AUG-3387, for COVID-19. More specifically, 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.



      In vitro preclinical testing has demonstrated that AUG-3387 effectively neutralizes SARS-CoV2 and has activity against all variant strains tested to date, including major COVID variants of concern: Alpha (B.1.1.7 ), Beta (B1.1.351), Gamma (P.1) and Kappa (B.1.617.1) and Delta (B.1.617.2). TFF and Augmenta have an ongoing commitment to monitor activity of AUG-3387 against emerging SARS-CoV-2 variants and will be completing in vivo preclinical efficacy studies in the coming weeks. Continued scale-up manufacturing of AUG-3387 continues, and the Companies expect completion of toxicology studies to enable human clinical trials in the months ahead.



      TFF also continues to work with its partner, PLUS Products, to develop Thin Film Freezing versions of cannabinoid products. PLUS Products is currently conducting consumer testing of specific formulations.

    Formation of Scientific Advisory Board

    TFF Pharmaceuticals also announced the formation of a Scientific Advisory Board, comprised of globally-recognized thought leaders in their respective fields of study. The SAB will advise TFF Pharmaceuticals across a range of issues, including internally developed programs and select external projects. Below is a list of our advisors and their affiliated institutions:

    • David N. Cornfield, M.D.

      Director of the Center for Excellence in Pulmonary Biology at Stanford, and Chief of the pediatric pulmonary, asthma, and sleep medicine divisions at Stanford University and Lucile Packard Children's Hospital
    • David Denning, FRCP, FRCPath, DCH, FMedSci

      Professor of Infectious Diseases in Global Health, University of Manchester
    • Anthony Hickey, Ph.D.

      Professor Emeritus in Pharmacoengineering and Molecular Pharmaceutics at the Eshelman School of Pharmacy of the University of North Carolina at Chapel Hill
    • Jay Peters, M.D.

      Chief of Pulmonary and Critical Care Medicine at the University of Texas Health Science Center at San Antonio
    • Ted M. Ross, Ph.D.

      Professor at the University of Georgia in the Animal Health Research Center, Center for Vaccines and Immunology, and the Department of Infectious Diseases
    • Mike Saag, M.D.

      Professor of Medicine at UAB School of Medicine, Director of the UAB Center for AIDS Research and Associate Dean for Global Health.
    • Drew Weismann, M.D., Ph.D.

      Roberts Family Professor in Vaccine Research at the Perelman School of Medicine at the University of Pennsylvania

    Financial Results 

    For the three months ended June 30, 2021, compared to the prior year: 

    • Research and Development (R&D) expenses: R&D expenses for the second quarter of 2021 were $2.8 million, compared to $2.6 million for the same period in 2020. 



    • General & Administrative (G&A) expenses: G&A expenses for the second quarter of 2021 were $2.4 million, compared to $1.3 million for the same period of 2020.  



    • Net Loss: TFF Pharmaceuticals reported a net loss for the second quarter of 2021 of $4.7 million, compared to a net loss of $3.8 million for the same period of 2020. 

    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 58 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, 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 and 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 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.

    TFF PHARMACEUTICALS, INC.

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

      Three Months

    Ended

    June 30,

    2021
      Three Months

    Ended

    June 30,

    2020
      Six Months

    Ended

    June 30,

    2021
      Six Months

    Ended

    June 30,

    2020
     




    Grant revenue
     $1,850  $  $26,165  $ 
    Operating expenses:            
    Research and development  2,762,170   2,567,771   8,040,422   4,803,313 
    General and administrative  2,351,007   1,274,803   4,998,422   2,892,727 
    Total operating expenses  5,113,177   3,842,574   13,038,844   7,696,040 
                     
    Loss from operations  (5,111,327)  (3,842,574)  (13,012,679)  (7,696,040)
                     
    Other income:                
    Other income  441,546      672,824    
    Interest income  14,069   25,995   29,568   82,263 
    Total other income  455,615   25,995   702,392   82,263 
                     
    Net loss $(4,655,712) $(3,816,579) $(12,310,287) $(7,613,777)
                     
    Net loss per share, basic and diluted $(0.18) $(0.20) $(0.51) $(0.40)
    Weighted average common shares outstanding, basic and diluted  25,369,144   19,071,658   24,261,032   19,040,134 
                     
               

    TFF PHARMACEUTICALS, INC.

    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

      June 30,  December 31, 
      2021  2020 
           
    ASSETS      
    Current assets:      
    Cash and cash equivalents $52,067,339  $35,300,805 
    Receivable due from collaboration agreement  489,221    
    Research and development tax incentive receivable  932,057    
    Prepaid assets and other current assets  1,968,726   2,258,229 
    Total current assets  55,457,343   37,559,034 
    Property and equipment, net  1,697,038   1,102,808 
    Total assets $57,154,381  $38,661,842 
             
    LIABILITIES AND STOCKHOLDERS' EQUITY        
             
    Current liabilities:        
    Accounts payable $1,509,224  $1,297,725 
    Deferred research grant revenue  25,000   24,315 
    Total liabilities  1,534,224   1,322,040 
             
    Commitments and contingencies        
             
    Stockholders' equity:        
    Common stock  25,372   22,535 
    Additional paid-in capital  102,301,550   71,648,453 
    Accumulated other comprehensive loss  (116,830)  (51,538)
    Accumulated deficit  (46,589,935)  (34,279,648)
    Total stockholders' equity  55,620,157   37,339,802 
    Total liabilities and stockholders' equity $57,154,381  $38,661,842 

    Company Contacts:

    Glenn Mattes

    President and CEO

    TFF Pharmaceuticals, Inc

    gmattes@tffpharma.com                                                                                                

    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.

    kcoleman@tffpharma.com                                                                                                

    817-989-6358

    Investor Relations Contact:  

    Corey Davis, Ph.D. 

    LifeSci Advisors 

    212-915-2577 

    cdavis@lifesciadvisors.com 

    Media Contact:

    Gwendolyn Schanker

    LifeSci Communications

    (269) 921-3607

    gschanker@lifescicomms.com 



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  3. AUSTIN, Texas, Aug. 05, 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 President and CEO Glenn Mattes will present a corporate overview at the SNN Virtual Investor Conference being held August 17 – 19, 2021.

    Mr. Mattes will deliver his corporate presentation on August 19th from 1:30 – 2:00 pm Eastern Time.

    Management will be available for one-on-one meetings to be held throughout the conference.

    Investors can register here: REGISTER

    About TFF Pharmaceuticals' Thin Film Freezing technology platform
    TFF Pharmaceuticals…

    AUSTIN, Texas, Aug. 05, 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 President and CEO Glenn Mattes will present a corporate overview at the SNN Virtual Investor Conference being held August 17 – 19, 2021.

    Mr. Mattes will deliver his corporate presentation on August 19th from 1:30 – 2:00 pm Eastern Time.

    Management will be available for one-on-one meetings to be held throughout the conference.

    Investors can register here: REGISTER

    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 TFF platform and its dry powder versions of Voriconazole and 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 Voriconazole and 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 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

    gmattes@tffpharma.com

    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.

    kcoleman@tffpharma.com

    817-989-6358

    Investor Relations Contact:  

    Corey Davis, Ph.D. 

    LifeSci Advisors 

    212-915-2577 

    cdavis@lifesciadvisors.com

    Media Contact:

    Gwendolyn Schanker

    LifeSci Communications

    (269) 921-3607

    gschanker@lifescicomms.com



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  4. AUSTIN, Texas, Aug. 04, 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 release its financial results and business update for the second quarter of 2021 on Thursday, August 12, 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 EDT. A question-and-answer session with investors will follow management's remarks.

    Conference Call and Webcast Information

    The Company will host…

    AUSTIN, Texas, Aug. 04, 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 release its financial results and business update for the second quarter of 2021 on Thursday, August 12, 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 EDT. A question-and-answer session with investors will follow management's remarks.

    Conference Call and Webcast Information

    The Company will host a conference call on Thursday, August 12, 2021, at 4:30 PM EDT to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

    Domestic Dial-In Number: Toll-Free: (866) 269-4261

    International Dial-In Number (323) 289-6581

    Conference ID: 6229028

    The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals' Website, https://tffpharma.com or directly at http://public.viavid.com/index.php?id=146022. Please access the Company's website 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 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 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 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.

    gmattes@tffpharma.com

    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.

    kcoleman@tffpharma.com

    817-989-6358

    Investor Relations:                                                                        

    Corey Davis, Ph.D. 

    LifeSci Advisors 

    cdavis@lifesciadvisors.com

    212-915-2577 

    Media Contact:

    Gwendolyn Schanker

    LifeSci Communications

    (269) 921-3607

    gschanker@lifescicomms.com

    Source: TFF Pharmaceuticals, Inc.



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  5. 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

    gmattes@tffpharma.com

    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.

    kcoleman@tffpharma.com

    817-989-6358

    Christopher Emig, Ph.D.

    President and CEO

    Augmenta Bioworks, Inc

    chris@augbio.com

    650-731-2842

    Investor Relations Contact:

    Corey Davis, Ph.D.

    LifeSci Advisors

    212-915-2577

    cdavis@lifesciadvisors.com

    Media Contact:

    Gwendolyn Schanker

    LifeSci Communications

    (269) 921-3607

    gschanker@lifescicomms.com

    Source: TFF Pharmaceuticals, Inc.



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  6. 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.

    kcoleman@tffpharma.com

    817-989-6358

    Investor Relations Contact:

    Corey Davis, Ph.D.

    LifeSci Advisors

    212-915-2577

    cdavis@lifesciadvisors.com



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  7. 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.

    gmattes@tffpharma.com

    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.

    kcoleman@tffpharma.com

    817-989-6358

    Investor Relations Contact:  

    Corey Davis, Ph.D. 

    LifeSci Advisors 

    212-915-2577 

    cdavis@lifesciadvisors.com

    Media Contact:

    Gwendolyn Schanker

    LifeSci Communications

    (269) 921-3607

    gschanker@lifescicomms.com



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  8. 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

    gmattes@tffpharma.com                                                                                              

    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.

    kcoleman@tffpharma.com                                                                                              

    817-989-6358

    Christopher Emig, Ph.D.                                                                                                             

    President and CEO

    Augmenta Bioworks, Inc

    chris@augbio.com

    650-731-2842                                              

    Investor Relations Contact: 

    Corey Davis, Ph.D.         

    LifeSci Advisors         

    212-915-2577                 

    cdavis@lifesciadvisors.com



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  9. 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

    gmattes@tffpharma.com                                                                                              

    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.

    kcoleman@tffpharma.com                                                                                              

    817-989-6358

    Investor Relations Contact: 

    Corey Davis, Ph.D.         

    LifeSci Advisors         

    212-915-2577                 

    cdavis@lifesciadvisors.com



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  10. AUSTIN, Texas, May 25, 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 management will present a corporate overview at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 11:30am EST.

    To register in advance for the corporate presentation, sign up here.

    Replay Link:
    A replay will be accessible on the Events & Presentations page of the Investors section on the Company's website at https://ir.tffpharma.com/events-and-presentations/events

    About TFF Pharmaceuticals
    TFF Pharmaceuticals, Inc. is a clinical-stage…

    AUSTIN, Texas, May 25, 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 management will present a corporate overview at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 11:30am EST.

    To register in advance for the corporate presentation, sign up here.

    Replay Link:

    A replay will be accessible on the Events & Presentations page of the Investors section on the Company's website at https://ir.tffpharma.com/events-and-presentations/events

    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

    gmattes@tffpharma.com

    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.

    kcoleman@tffpharma.com

    817-989-6358

    Investor Relations Contact: 

    Corey Davis, Ph.D. 

    LifeSci Advisors 

    212-915-2577 

    cdavis@lifesciadvisors.com

    Media Contact:

    Gwendolyn Schanker

    LifeSci Communications

    (269) 921-3607

    gschanker@lifescicomms.com 



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  11. Pivotal Trials to Begin in 2H-2021 for Voriconazole Inhalation Powder for the Treatment of Invasive Pulmonary Aspergillosis (IPA) and Tacrolimus Inhalation Powder for Immunosuppression in Solid Organ Transplantation

    Patent Filed for Once-a-Day Dosing for Tacrolimus Inhalation Powder, Achieving Therapeutic Blood Levels with a Single Low Dose

    Science Day to be Held in June to Highlight Thin Film Freezing Platform Technology

    Conference Call and Live Webcast Scheduled Today, Thursday, May 13, 2021, at 4:30pm EDT

    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 reported…

    Pivotal Trials to Begin in 2H-2021 for Voriconazole Inhalation Powder for the Treatment of Invasive Pulmonary Aspergillosis (IPA) and Tacrolimus Inhalation Powder for Immunosuppression in Solid Organ Transplantation

    Patent Filed for Once-a-Day Dosing for Tacrolimus Inhalation Powder, Achieving Therapeutic Blood Levels with a Single Low Dose

    Science Day to be Held in June to Highlight Thin Film Freezing Platform Technology

    Conference Call and Live Webcast Scheduled Today, Thursday, May 13, 2021, at 4:30pm EDT

    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 reported financial results for the first quarter ended March 31, 2021, as well as provided a business update on recent corporate and clinical developments. The Company will discuss the clinical, corporate and financial highlights on a conference call and live webcast, scheduled today, Thursday, May 13, 2021, at 4:30pm EDT.

    "We continue to make progress with our clinical development programs: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder," said Glenn Mattes, President and CEO of TFF Pharmaceuticals. "This progress, along with better-than-expected clinical data, will allow us to initiate clinical trials designed to achieve registration for both of these important programs by the end of 2021."

    "The data we have seen from our Tacrolimus Inhalation Powder trial suggests that we can achieve efficacious immunosuppressive blood levels of tacrolimus with an inhaled, once-a-day, low-dose formulation," said Mattes. "We believe that inhaled tacrolimus' ability to reduce the fluctuations of bioavailability offers a compelling advantage over oral tacrolimus, as physicians often attribute the peaks and troughs of oral delivery with suboptimal efficacy and exacerbated side effects."

    "We have filed a US patent based on this once-a-day dosing development, which could have major implications for lung transplant patients, and potentially for heart, kidney and liver transplant patients as well," continued Mattes. "Based on our recent research, we believe the peak yearly sales of tacrolimus in all four indications could exceed $1 billion dollars."

    "This quarter, we've also made notable progress with a number of our strategic partners," said Mattes. "Our collaborations with UNION therapeutics on niclosamide and Augmenta Bioworks on monoclonal antibodies are progressing on plan, and our partner in the cannabis space, PLUS Products, is seeing positive initial manufacturing data and strong market interest.

    "Also, our scientific collaboration partners at the University of Texas at Austin generated meaningful new data that continues to demonstrate the advantages of our Thin Film Freezing platform over other competing technologies," said Mattes. "This is true for both small molecule therapeutic applications, as well as high molecular weight biologics like proteins, including monoclonal antibodies, messenger RNA, and plasmid DNA, where our technology offers the only viable solution for dry powder reformulation."

    "To highlight these important scientific developments to as broad an audience as possible, we are pleased to announce that the Company will host a virtual Science Day in June," said Mattes. "This event will provide a scientific perspective on our Thin Film Freezing platform technology from external scientific key opinion leaders."

    "The growing portfolio of business development partnerships and the pace of our clinical and scientific progress continued to be impressive during the quarter," concluded Mattes. "This remains a testament to the outstanding efforts of our professionals, as well as the continued recognition that our technology can have game-changing consequences for the industry."

    Conference Call and Webcast Information

    The Company will host a conference call today, Thursday, May 13, 2021, at 4:30 pm, Eastern Daylight Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

    Domestic Dial-In Number: Toll-Free: (800) 816-3024

    International Dial-In Number (857) 770-0106

    Conference ID: 5777388

    The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals' Website, https://tffpharma.com or directly at https://edge.media-server.com/mmc/p/o4wvnbiv. Please access the Company's website 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 in the Events Calendar of the Investors section.

    Recent Clinical and Corporate Highlights:

    • Voriconazole Inhalation Powder In March, we announced the successful completion of the Phase 1 clinical trial and final data for Voriconazole Inhalation Powder for the treatment of invasive pulmonary aspergillosis (IPA).



      TFF demonstrated that doses of 10, 20, 40, and 80 mg could be delivered twice daily using a dry powder inhaler device with no significant adverse events. Evaluation of the pharmacokinetic profile of the Voriconazole Inhalation Powder demonstrated that mean peak plasma voriconazole levels reached concentrations of 227 ng/mL following repeated dosing at 80 mg twice daily for 7 days, without any reports of significant adverse events. Based on the results of the Phase 1 trial, the Company will study the 80 mg dose of Voriconazole Inhalation Powder for the upcoming pivotal trial where it will be compared to the oral form of voriconazole.



      TFF has completed dosing in a GLP 13-week chronic toxicology study and has successfully completed the first of two dosing cohorts in asthma patients to evaluate safe dosing in patients with hyperreactive airways. There have been no serious adverse events reported in these cohorts. The Company is currently in active preparations for an end of Phase 1 meeting with the FDA, and we anticipate this meeting will be held after the dosing in this Phase 1b asthma study is complete. We then expect to initiate a pivotal clinical trial designed to demonstrate efficacy for treating patients with IPA or for preventing infection in patients at high risk for developing IPA infections.
    • Tacrolimus Inhalation Powder: Enrollment in the final cohort of our Phase 1 study is ongoing and is expected to be completed shortly. Earlier in March, we announced the successful completion of the single ascending dose (SAD) portion of the Phase 1 study of Tacrolimus Inhalation Powder. In the SAD phase of the trial, we safely administered single doses of 0.5, 1.0, 2.5 and 5 mg to healthy normal volunteers. We had planned to dose an additional cohort of subjects at 10 mg, but cancelled this cohort after reaching efficacious dose levels below 10 mg. In the multiple ascending dose (MAD) part of the study, we dosed subjects in cohort 1 and 2 with twice daily doses of 0.5 and 1.0 mg over 7 days. These dose levels reached steady-state concentrations that are associated with effective immunosuppression. Of particular note, we dosed cohort-3 subjects with a single 1.5 mg dose each day for 7 days, and these subjects were able to reach efficacious immunosuppressive levels from once-a-day dosing with a low-dose concentration of inhaled tacrolimus.



      We have also completed a GLP 26-week chronic toxicology study that will be used to support registration, and we remain on track to begin the pivotal trial work designed to demonstrate efficacy of inhaled tacrolimus for the prevention of lung allograft rejection. The enhanced bioavailability of inhaled tacrolimus, coupled with its ability to bypass the gastrointestinal tract, could also result in expanded therapeutic applications into other solid organ transplants where significant drug-drug interactions and food effects are a factor.
    • Strategic Business Development and Partnership Activities – Governmental and defense contracting agencies: In April, we announced that Leidos, a Fortune 500 information technology, engineering and science solutions and services leader, awarded the Company a subcontract to participate in the Personalized Protective Biosystems (PPB) Program to develop next-generation chemical and biological protection for U.S warfighters and stability operators. TFF Pharmaceuticals will utilize its Thin Film Freezing platform to formulate a series of countermeasures designed to neutralize chemical and biological agents at the site of vulnerable tissue barriers, including the skin, eyes and respiratory system.



      We continue to engage and collaborate with various government and defense contracting agencies in an effort to utilize the Company's TFF technology platform to formulate dry powder vaccines and therapeutics for delivery via reconstitution for lung or nasal inhalation. This includes our 3-year Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) for biodefense countermeasures, and our early-stage universal influenza work with the University of Georgia's Center for Vaccines and Immunology, part of the NIH's Collaborative Influenza Vaccine Innovation Centers (CIVICs).



      Strategic Business Development and Partnership Activities – Biopharmaceutical companies and research institutions: Under our worldwide licensing agreement with UNION therapeutics for thin film freezing technology used in combination with niclosamide, our oral and powdered niclosamide formulations are moving forward to first-in-human trials. Recent data from UNION suggests that niclosamide is effective against the new prevalent British B.1.1.7 and South African B.1.351 COVID-19 variants.



      "We are pleased with our ongoing collaboration with TFF Pharmaceuticals, and are happy to learn that the TFF niclosamide program is advancing through development," said Dr. Kim Kjøller, Chief Executive Officer of UNION therapeutics. "We share the desire to provide much-needed therapeutics to COVID-19 stricken patients across the patient continuum."



      In a second COVID-related collaboration, the worldwide joint venture between TFF and Augmenta Bioworks is now well underway. This innovative, first-of-its kind program will seek to apply our Thin Film Freezing technology to develop dry powder-based monoclonal antibodies targeting COVID-19.



      "Our Joint Collaboration with TFF is right on track," said Christopher Emig, Ph.D., CEO and Co-founder of Augmenta Bioworks, Inc. "We are making great progress on our broadly neutralizing antibody therapy. We are looking forward to the results of our IND enabling studies and getting this much-needed therapeutic into the clinic as quickly as possible. Combining Augmenta's discovery capabilities with TFF's formulation and drug development expertise has been an incredibly fruitful partnership."



      Cannabis Development and Commercialization: Our partner in the cannabis space, PLUS Products, has been producing thin film freezing formulations of cannabis and is planning to launch a new product based on this technology.



      "The results on the preliminary manufacturing runs with the TFF technology have been even better than we had hoped," said Jake Heimark, CEO & Co-founder of PLUS Products. "And the concept research on dry powder inhalation with the retail distribution channels in California has created a high level of interest in the product category."



      Public Offering: As announced previously on March 26, 2021, the Company closed on an underwritten offering of 2,140,000 shares of its common stock. Proceeds from the offering totaled approximately $30,000,000, before deducting underwriting discounts and other offering expenses. At the end of the quarter, with the net proceeds from this offering, the Company's liquidity included approximately $58.1 million in cash and cash equivalents.

    Financial Results

    For the three months ended March 31, 2021, compared to the prior year:

    • Research and Development (R&D) expenses: R&D expenses for the first quarter of 2021 were $5.3 million, compared to $2.2 million for the same period in 2020.
    • General & Administrative (G&A) expenses: G&A expenses for the first quarter of 2021 were $2.6 million, compared to $1.6 million for the same period of 2020.
    • Net Loss: TFF Pharmaceuticals reported a net loss for the first quarter of 2021 of $7.7 million, compared to a net loss of $3.8 million for the same period of 2020.

    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 TFF platform and its dry powder versions of various drugs, vaccines and biologics 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 any drugs, vaccines or biologics, (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 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.

    TFF PHARMACEUTICALS, INC.

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

     

     

     

    Three Months Ended

    March 31,

    2021

     

    Three Months Ended

    March 31,

    2020

     

    Grant revenue

     

    $

    24,315

     

     

    $

     

    Operating expenses:

     

     

     

     

    Research and development

     

     

    5,278,252

     

     

     

    2,235,542

     

    General and administrative

     

     

    2,647,415

     

     

     

    1,617,924

     

    Total operating expenses

     

     

    7,925,667

     

     

     

    3,853,466

     

     

     

     

     

     

    Loss from operations

     

     

    (7,901,352

    )

     

     

    (3,853,466

    )

     

     

     

     

     

    Other income:

     

     

     

     

    Other income

     

     

    231,278

     

     

     

     

    Interest income

     

     

    15,499

     

     

     

    56,268

     

    Total other income

     

     

    246,777

     

     

     

    56,268

     

     

     

     

     

     

    Net loss

     

    $

    (7,654,575

    )

     

    $

    (3,797,198

    )

    Net loss per share, basic and diluted

     

    $

    (0.33

    )

     

    $

    (0.20

    )

     

     

     

     

     

    Weighted average common shares outstanding, basic and diluted

     

     

    23,140,607

     

     

     

    19,008,611

     

    TFF PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

     

     

     

    March 31,

    2021

    December 31,

    2020

     

     

    (Unaudited)

     

    ASSETS

     

    Current assets:

     

    Cash and cash equivalents

    $

    58,055,122

     

     

    $

    35,300,805

     

    Prepaid assets and other current assets

     

    1,721,184

     

     

     

    2,258,229

     

    Total current assets

     

    59,776,306

     

     

     

    37,559,034

     

    Property and equipment, net

     

    1,577,441

     

     

     

    1,102,808

     

    Total assets

    $

    61,353,747

     

     

    $

    38,661,842

     

     

     

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

     

    Current liabilities:

     

     

     

    Accounts payable

    $

    1,817,034

     

     

    $

    1,297,725

     

    Deferred research grant revenue

     

     

     

     

    24,315

     

    Total liabilities

     

    1,817,034

     

     

     

    1,322,040

     

     

     

     

     

    Commitments and contingencies

     

     

     

     

     

     

     

    Stockholders' equity:

     

     

     

    Common stock

     

    25,364

     

     

     

    22,535

     

    Additional paid-in capital

     

    101,535,068

     

     

     

    71,648,453

     

    Accumulated other comprehensive loss

     

    (89,496

    )

     

     

    (51,538

    )

    Accumulated deficit

     

    (41,934,223

    )

     

     

    (34,279,648

    )

    Total stockholders' equity

     

    59,536,713

     

     

     

    37,339,802

     

    Total liabilities and stockholders' equity

    $

    61,353,747

     

     

    $

    38,661,842

     

     

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  12. Company conference call and webcast at 4:30 PM EDT

    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 and business update for the first quarter of 2021 on Thursday, May 13, 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 EDT. A question-and-answer session with investors will follow management's remarks.

    Conference Call Details:

    Thursday, May 13, 2021, 4:30 PM Eastern…

    Company conference call and webcast at 4:30 PM EDT

    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 and business update for the first quarter of 2021 on Thursday, May 13, 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 EDT. A question-and-answer session with investors will follow management's remarks.

    Conference Call Details:

    Thursday, May 13, 2021, 4:30 PM Eastern Time (EDT)

    Domestic Dial-In Number: Toll-Free: (800) 816-3024

    International Dial-In Number (857) 770-0106

    Conference ID: 5777388

    Webcast Registration Link: https://edge.media-server.com/mmc/p/o4wvnbiv

    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.

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  13. Company's Thin Film Freezing platform to be developed for use in rapidly neutralizing chemical and biological threats at vulnerable tissue barriers to increase soldier protection and decrease operational burden

    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 Leidos, a leading Fortune 500 information technology, engineering and science solutions and services leader, has awarded the Company a subcontract to participate in the Personalized Protective Biosystems (PPB) Program to develop next-generation chemical and biological protection for U.S warfighters…

    Company's Thin Film Freezing platform to be developed for use in rapidly neutralizing chemical and biological threats at vulnerable tissue barriers to increase soldier protection and decrease operational burden

    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 Leidos, a leading Fortune 500 information technology, engineering and science solutions and services leader, has awarded the Company a subcontract to participate in the Personalized Protective Biosystems (PPB) Program to develop next-generation chemical and biological protection for U.S warfighters and stability operators.

    The PPB research program, overseen by the Defense Advanced Research Projects Agency (DARPA), will develop an integrated system that simultaneously reduces protective equipment needs while increasing protection for the individual against existing and future chemical and biological (CB) threats. This will be achieved through lightweight materials that protect the warfighter or stability operator from exposure to CB threats, while simultaneously providing a second layer of protection, at the tissue barrier, with bio-molecular, commensal organisms, or other technologies that protect the skin, eyes, and airway from CB threats. Successful PPB technologies could change how the military and public health communities perform in unpredictable threat environments.

    Under the 60-month, three-phase subcontract with Leidos, TFF Pharmaceuticals will utilize its Thin Film Freezing platform to formulate a series of countermeasures designed to neutralize chemical and biological agents at the site of vulnerable tissue barriers, including the skin, the eyes and the respiratory system. Phase I of the program will include the development and validation of methods to quantify countermeasures and the formulation of countermeasures for delivery to the various tissue. Phase II will include the scale up manufacturing of countermeasure formulations for preclinical studies, demonstration of the deliverability of countermeasure products and meeting with the FDA to determine a path to GMP production of the countermeasure formulations, nonclinical safety testing, and a pathway to human clinical testing. Phase III will include plans for scale-up manufacturing for human safety trials.

    "We are very pleased that Leidos selected our Thin Film Freezing platform to help develop the next generation of chemical and biological protective technologies for our frontline warfighters and stability operators," said Glenn Mattes, President and CEO of TFF Pharmaceuticals. "The Personalized Protective Biosystems program will develop groundbreaking technology and we are proud to be able to play a role in this program that will have strategic impact to this country for years to come."

    About Leidos

    Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 37,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Va., Leidos reported annual revenues of approximately $11.09 billion for the fiscal year ended January 3, 2020. For more information, visit www.leidos.com.

    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 Company's participation in the Personalized Protective Biosystems (PPB) Program and the benefits of the Company's TFF platform. 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 PPB not successfully develop the proposed countermeasures utilizing the Company's TFF platform, (ii) the risk that Leidos and the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of the proposed countermeasures utilizing the Company's TFF platform, (iii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, and (iv) those other risks disclosed in the section "Risk Factors" included in the Company's 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.

    "This Press Release was cleared by DARPA under Distribution Statement "A" (Approved for Public Release, Distribution Unlimited)."

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  14. 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 has priced an underwritten offering of 2,855,000 shares of its common stock, 2,140,000 shares of which are to be sold by the Company and 715,000 shares of which are to be sold by Lung Therapeutics, Inc. ("Selling Stockholder"), at an offering price of $14.00 per share. TFFP expects the aggregate gross proceeds from this offering to be approximately $40 million, before deducting the underwriting discount and commissions and other estimated offering expenses, of which approximately $10 million of the gross…

    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 has priced an underwritten offering of 2,855,000 shares of its common stock, 2,140,000 shares of which are to be sold by the Company and 715,000 shares of which are to be sold by Lung Therapeutics, Inc. ("Selling Stockholder"), at an offering price of $14.00 per share. TFFP expects the aggregate gross proceeds from this offering to be approximately $40 million, before deducting the underwriting discount and commissions and other estimated offering expenses, of which approximately $10 million of the gross proceeds will be received by the Selling Stockholder. TFFP expects to close the offering, subject to customary conditions, on or about March 30, 2021.

    TFFP intends to use the net proceeds from the proposed offering for working capital and general corporate purposes.

    Roth Capital Partners acted as sole book-running manager for the offering.

    The offering of common stock was made pursuant to TFF Pharmaceuticals' shelf registration statement filed with the Securities and Exchange Commission ("SEC") and declared effective. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

    A preliminary prospectus supplement has been filed with the SEC and a final prospectus supplement will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered may be obtained, when available, from Roth Capital Partners, LLC. 888 San Clemente Drive, Newport Beach, CA 92660, Attention: Prospectus Department, by telephone at (800) 678-9147 or by email at rothecm@roth.com. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the SEC's website at http://www.sec.gov.

    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.

    Safe Harbor

    This press release contains forward-looking statements regarding the expected closing of the underwritten offering and the intended use of proceeds from the offering. The offering is subject to customary closing conditions and there can be no assurance as to whether or when the offering may be completed. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including those risks disclosed under the caption "Risk Factors" in the preliminary prospectus supplement related to the offering. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. The Company does not undertake, and specifically disclaims any obligation, to update or revise such statements to reflect new circumstances or unanticipated events as they occur.

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  15. Reports positive Phase 1 study results for Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder

    Awarded subcontract license by U.S. government agency to formulate biologic countermeasures to be used by the U.S. military

    Announces feasibility agreements with Greenlight Biosciences for Covid-19 mRNA Vaccine Reformulation and NeuroRx for Covid-19 therapeutic for critically ill patients

    Conference call and live webcast scheduled today, Wednesday, March 10, 2021 at 4:30pm EST

    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 reported financial results for the…

    Reports positive Phase 1 study results for Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder

    Awarded subcontract license by U.S. government agency to formulate biologic countermeasures to be used by the U.S. military

    Announces feasibility agreements with Greenlight Biosciences for Covid-19 mRNA Vaccine Reformulation and NeuroRx for Covid-19 therapeutic for critically ill patients

    Conference call and live webcast scheduled today, Wednesday, March 10, 2021 at 4:30pm EST

    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 reported financial results for the fourth quarter and full year ended December 31, 2020, as well as provided a business update on recent corporate and clinical developments. The Company will discuss the clinical, corporate and financial highlights on a conference call and live webcast, scheduled today, Wednesday, March 10, 2021 at 4:30pm EST.

    "2020 was a remarkable year of accomplishment and building momentum for TFF Pharmaceuticals, due to success in achieving key milestones in our two-pronged business model of internal development of high-value, high-need therapeutics, combined with a focused and aggressive approach to seek out partners, licensees and collaborators for our breakthrough Thin Film Freezing platform technology," said Glenn Mattes, President and CEO of TFF Pharmaceuticals.

    "Our internal development programs are progressing ahead of expectations, as we are seeing very positive clinical results in both Phase 1 trials for our Voriconazole Inhalation Powder program, to treat the severe and life-threatening disease of Invasive Pulmonary Aspergillosis, as well as for our Tacrolimus dry-powder program for the prevention of lung transplant rejection."

    "Final data for our Voriconazole product, the first-ever clinical study of a direct-to-lung, Thin Film Freezing (TFF) dry-powder formulation, resulted in blood levels greater than two-fold higher than those shown to clear complex IPA infections, with no significant adverse events," said Mattes. "And our Tacrolimus product was able to reach therapeutic blood levels of 5-16 ng/mL in all patients from a single inhaled dose of 5 mg of our reformulated Inhalation Powder, without significant adverse events. Both these very significant results bode well for our upcoming pivotal trials for these drugs, which address large markets with unmet needs."

    "We are also honored to announce today a strategically important contract for the Company with a major government research agency to formulate dry powder versions of a suite of biological countermeasures that is intended for use by our nation's military forces," continued Mattes. "This is another meaningful event for TFF as we continue to build our portfolio of development agreements with pharmaceutical companies, the government and academia. We look forward to providing more details on this contract pending security review and approval of further news distribution from the government and the prime contractor."

    "And our ubiquitous and disruptive Thin Film Freezing technology continues to garner considerable attention from potential industry partners," said Mattes. "With the potential to mitigate the need for cold chain storage and distribution of vaccines, as well as the first-of-its-kind capability to reformulate large, complex biologic molecules, thin film freezing has generated strong interest from biotechnology companies, as well as some of the largest developers of vaccines and anti-virals."

    "This is evident by the recent feasibility collaborations by GreenLight Biosciences, a pioneering mRNA company, to reformulate their mRNA Covid-19 vaccine candidate, and by NeuroRx, to reformulate their product candidate, ZYESAMI, a therapeutic for seriously ill Covid-19 patients," said Mattes. "The interest from these two companies, among many others, demonstrates the growing recognition that our technology can dramatically advance potential vaccines and therapeutics."

    "Our progress this year has firmly solidified the enormous potential on our Thin Film Freezing technology to the vaccine, biotechnology and drug development communities," concluded Mattes. "The breakthrough and disruptive capabilities of our platform technology, and our ability to leverage this across both internal development programs and external business development opportunities has helped expand the depth of our business and will continue to fuel our future growth."

    Conference Call and Webcast Information

    The Company will host a conference call today, Wednesday, March 10, 2021, at 4:30 pm, Eastern Standard Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

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

    International Dial-In Number (857) 770-0110

    Conference ID: 9195779

    The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals' Website, https://tffpharma.com or directly at https://edge.media-server.com/mmc/p/ev6cv5ub . Please access the Company's website 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 in the Events Calendar of the Investors section.

    Recent Clinical and Corporate Highlights:

    • Voriconazole Inhalation Powder In March 2021, we announced the successful completion of the Phase 1 clinical trial and final data for Voriconazole Inhalation Powder for the treatment of invasive pulmonary aspergillosis (IPA), an inhaled dry powder version of voriconazole.



      Through completion of the Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts, TFF demonstrated that doses of 10, 20, 40, and 80 mg could be delivered twice daily using a dry powder inhaler device with no significant adverse events. There was no evidence of treatment-related or dose-related trends in the reporting of treatment emergent adverse events, throughout the study. No subjects experienced any dose limiting toxicity events during the study.



      Evaluation of the pharmacokinetic profile of the Voriconazole Inhalation Powder demonstrated that mean peak plasma voriconazole levels reached concentrations of 227 ng/mL following repeated dosing at 80 mg twice daily for 7 days, without any reports of significant adverse events. Based on the results of the Phase 1 trial, the Company will study the 80 mg dose of Voriconazole Inhalation Powder for the upcoming pivotal trial where it will be compared to the oral form of voriconazole.
    • Tacrolimus Inhalation Powder: In March 2021, we also announced the successful dosing completion in the Single Ascending Dose portion of the Phase 1 study of Tacrolimus Inhalation Powder and that the Multiple Ascending Dose portion is progressing. The SAD portion of the study indicated that TFF's Tacrolimus Inhalation Powder was able to reach therapeutic blood levels of 5-16 ng/mL in all patients from a single inhaled dose of 5 mg of Tacrolimus Inhalation Powder, without significant adverse events.



      The ability to reach therapeutic blood levels efficiently, with low doses of the inhaled powder, suggests that Tacrolimus Inhalation Powder may have application beyond lung transplant, potentially in heart, kidney and liver transplant patients.
    • Strategic Business Development and Partnership Activities – Governmental and defense contracting agencies: TFF has been awarded a subcontract license by a U.S. government research agency to formulate dry powder versions of biologic countermeasures products to be used by the U.S. military. Our technology will be used to develop topical, ophthalmic and inhaled products, and as a result of this contract, TFF has been designated as an approved subcontractor vendor, which will facilitate additional work with the government. TFF will provide greater detail on the program pending security review approvals of further news distribution from the U.S. government and our prime contractor partner.



      In April of 2020, TFF Pharmaceuticals and USAMRIID, 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 Thin Film Freeze Drying of various biodefense countermeasures 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 and our next steps will be in vivo testing in appropriate animal models.



      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.
    • Strategic Business Development and Partnership Activities – Biopharmaceutical companies and research institutions: TFF recently announced a feasibility and material transfer agreement to evaluate a dry powder formulation of an early-stage Covid-19 mRNA vaccine candidate for Greenlight Biosciences. The goal of this feasibility work is to formulate and identify an optimal formulation of the Greenlight Biosciences mRNA product candidate in a dry powder form, which has superior stability as a dry powder, maintains the particle size of the mRNA, maintains a high encapsulation efficiency and has rapid reconstitution characteristics for injection.



      TFF also entered into a feasibility and material transfer agreement with NeuroRx to determine the compatibility of NeuroRx's ZYESAMI™ (aviptadil, previously RLF-100™) as a dry powder formulation using TFF's thin-film freezing technology. TFF intends to formulate and identify an optimal formulation of ZYESAMI in a dry powder form, with the goal of providing superior aerosol properties for delivery directly to the lungs. ZYESAMI is a recombinant form of a naturally occurring peptide found in the lung called Vasoactive Intestinal Peptide (VIP), which has been found to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. The ability to deliver this drug directly to the lung via inhalation could have important therapeutic implications and potentially broaden the application of the drug to patients less severely affected with Covid-19.



      In our worldwide licensing agreement with UNION Therapeutics for thin film freezing technology used in combination with niclosamide, our oral and powdered niclosamide formulations are moving forward to first-in-human trials.



      Our relationship with Felix Biotechnology is on track as we are working with their lead bacteriophage product for inhalation delivery directly to the lungs of patients. And our work with Augmenta Bioworks is on track as well. Our partnered lead monoclonal antibody product, targeting Covid-19 is scheduled to begin human trials later this year.



      In April of 2020, TFF and the University of Georgia's Center for Vaccines and Immunology entered into a research and development agreement to test the immunogenicity and efficacy of universal influenza hemagglutinin (HA) recombinant vaccines following the TFF process. In late 2020, we announced positive preclinical immunogenicity and efficacy data from TFF formulated UGA universal Influenza HA recombinant vaccines. Animals were vaccinated with HA vaccines with or without adjuvants and challenged with H1N1 and H3N2 influenza viruses. The TFF HA vaccines elicited equivalent neutralizing antibodies and protection against influenza virus infection compared to liquid formulations.



      These results provide further evidence that Thin Film Freezing can convert liquid forms of vaccines that require cold chain storage into a much more stable dry powder form for ultimate use.



      TFF continues to engage with several leading multi-national pharma companies in an effort to enter into feasibility projects taking the partner's product candidates, whether small molecule, large molecule, biologics, enzymes, antibodies, gene therapy, DNA derived therapy and/or vaccines, to utilize the Company's Thin Film Freezing technology platform to deliver new and innovative products directly to the lung.
    • CBD Development and Commercialization: Our partner in the cannabinoid space, PLUS Products, is now producing thin film freezing formulations of cannabinoids and is planning to launch a new product based on this technology toward the end of the second quarter of 2021.

    Financial Results

    For the year ended December 31, 2020, compared to 2019

    • Cash Position: As of December 31, 2020, TFF Pharmaceuticals reported cash and cash equivalents of $35.3 million.
    • Research and Development (R&D) expenses: R&D expenses for 2020 were $10.7 million, compared to $8.8 million in 2019.
    • General & Administrative (G&A) expenses: G&A expenses for 2020 were $8.0 million, compared to $3.2 million in 2019.
    • Net Loss: TFF Pharmaceuticals reported a net loss for 2020 of $18.6 million, compared to a net loss of $11.9 million in 2019.

    For the three months ended December 31, 2020, compared to the prior year

    • Research and Development (R&D) expenses: R&D expenses for the fourth quarter of 2020 were $3.1 million, compared to $3.3 million for the same period in 2019.
    • General & Administrative (G&A) expenses: G&A expenses for the fourth quarter of 2020 were $2.9 million, compared to $1.4 million for the same period of 2019.
    • Net Loss: TFF Pharmaceuticals reported a net loss for the fourth quarter of 2020 of $5.9 million, compared to a net loss of $4.7 million for the same period of 2019.

    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 TFF platform and its dry powder versions of various drugs, vaccines and biologics 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 any drugs, vaccines or biologics , (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 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.

    TFF PHARMACEUTICALS, INC.

    UNAUDITED CONDENSED STATEMENTS OF OPERATIONS

     

     

    Three Months

    Ended

    December 31, 2020

     

     

    Three Months

    Ended

    December 31,

    2019

     

     

    Year Ended

    December 31, 2020

     

    Year Ended

    December 31, 2019

    Operating expenses

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

    $

    3,054,583

     

    $

    3,268,180

     

     

    $

    10,681,565

     

     

    $

    8,822,226

     

    General and administrative

     

    2,864,446

     

     

    1,443,640

     

     

     

    8,012,085

     

     

     

    3,165,331

     

    Total operating expenses

     

    5,919,029

     

     

    4,711,820

     

     

     

    18,693,650

     

     

     

    11,987,557

     

    Loss from operations

     

    (5,919,029

    )

     

    (4,711,820

    )

     

     

    (18,693,650

    )

     

     

    (11,987,557

    )

    Other income

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income

     

    23,607

     

     

    49,630

     

     

     

    126,416

     

     

     

    117,329

     

    Total other income

     

    23,607

     

     

    49,630

     

     

     

    126,416

     

     

     

    117,329

     

    Net loss

     

    (5,895,422

    )

     

    (4,662,190

    )

     

     

    (18,567,234

    )

     

     

    (11,870,228

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Preferred stock dividend

     

    __

     

     

    (106,483

    )

     

     

    __

     

     

    (875,359

    )

    Deemed dividend for beneficial

    conversion feature of Series

    A Preferred Stock

    $

    __

     

    $

    (23,929,751)

     

     

    $

    __

     

    $

    (23,929,751

    )

    Net loss applicable to common

    stock per share, basic

    and diluted

    $

    (0.26

    )

    $

    (2.00

    )

     

    $

    (0.91

    )

     

    $

    (5.31

    )

    Weighted average common

    shares outstanding, basic

    and diluted

     

    22,759,329

     

     

    14,338,249

     

     

     

    20,425,162

     

     

     

    6,904,983

     

    TFF PHARMACEUTICALS, INC.

    CONDENSED BALANCE SHEETS

     

     

     

    As of

    December 31,

    2020

     

    As of

    December 31,

    2019

     

    Assets

     

     

    (Unaudited)

     

     

     

    (Unaudited)

     

    Current Assets

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    35,300,805

     

     

    $

    28,094,936

     

    Prepaid assets and other current assets

     

     

    2,258,229

     

     

     

    1,092,462

     

    Total Current Assets

     

     

    37,559,034

     

     

     

    29,187,398

     

    Property and equipment, net

     

     

    1,102,808

     

     

     

    __

     

    Total Assets

     

    $

    38,661,842

     

     

    $

    29,187,398

     

     

     

     

     

     

     

     

     

     

    Liabilities and Stockholders' Equity

     

     

     

     

     

     

     

     

    Current Liabilities

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    1,297,725

     

     

    $

    410,638

     

    Deferred research grant revenue

     

     

    24,315

     

     

     

    __

     

    Total Current Liabilities

     

     

    1,322,040

     

     

     

    410,638

     

     

     

     

     

     

     

     

     

     

    Accrued research and development expense

     

     

    __

     

     

     

    1,132,013

     

    Total Liabilities

     

     

    1,322,040

     

     

     

    1,542,651

     

     

     

     

     

     

     

     

     

     

    Stockholders' Equity:

     

     

     

     

     

     

     

     

    Common stock, $0.001 par value, 45,000,000 shares

    authorized; 22,534,874 and 18,450,992 shares issued and

    outstanding as of December 31, 2020 and 2019, respectively

     

     

    22,535

     

     

     

    18,451

     

    Additional paid-in capital

     

     

    71,648,453

     

     

     

    43,338,710

     

    Accumulated other comprehensive loss

     

     

    (51,538)

     

     

     

    __

     

    Accumulated deficit

     

     

    (34,279,648

    )

     

     

    (15,712,414)

    )

    Total Stockholders' Equity

     

     

    37,339,802

     

     

     

    27,644,747

    )

     

     

     

     

     

     

     

     

     

    Total Liabilities and Stockholders' Equity

     

    $

    38,661,842

     

     

    $

    29,187,398

     

     

    View Full Article Hide Full Article
  16. RADNOR, Pa. and AUSTIN, Texas, March 9, 2021 /PRNewswire/ -- NeuroRx, Inc. and TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) are announcing that the companies have entered into a feasibility and material transfer agreement (Feasibility Agreement).  Under the Feasibility Agreement, NeuroRx is delivering ZYESAMI™ (aviptadil, synthetic VIP) materials to TFF in order to perform feasibility formulation work and testing. The goal of this feasibility work is to formulate and identify an optimal, long term-stable formulation of ZYESAMI™ in a dry powder form which has superior aerosol properties for delivery directly to the lungs.

    ZYESAMI is a synthetic form of a naturally occurring peptide found in the lung called Vasoactive Intestinal Peptide (VIP), which is known to protect the Alveolar Type II cell that is targeted by the SARS-CoV-2 virus. The symptoms of COVID-19 are attributable to decreased surfactant production and increased cytokine production caused by Coronavirus infection of the Type II cell.  This may also be a common pathway in sepsis-induced Acute Respiratory Distress Syndrome (ARDS) and Checkpoint Inhibitor induced pneumonitis associated with certain cancer drugs.

    Loss of surfactant production in the lung may be the direct cause of the profound hypoxia or respiratory failure seen in COVID-19. The ability to deliver VIP directly to the lung via inhalation could have important therapeutic implications and potentially broaden the application of the drug to patients less severely affected with Covid-19.

    "We are excited that ZYESAMI has demonstrated a highly significant reduction in time to hospital discharge for seriously ill Covid-19 patients treated with High Flow Nasal Oxygen, along with an increased likelihood of recovery and excellent safety," said Jonathan C. Javitt, M.D., M.P.H., CEO of NeuroRx. "Although our current production methods yield a drug that is sufficiently stable for emergency use, a long-term, shelf stable formulation will be needed for ongoing use of ZYESAMI, once the pandemic subsides. The thin film freezing technology holds great promise in potentially making this available to patients with other stages of Covid-19 with an inhaled form of ZYESAMI."

    "The work being done by the NeuroRx team with ZYESAMI on behalf of critically ill patients with Covid-19 Respiratory Failure is both remarkable and gratifying," said Glenn Mattes, President & CEO of TFF Pharmaceuticals, "The potential opportunity to bring this important new therapeutic to patients earlier in the treatment cycle is exciting. We are very pleased to be collaborating with the NeuroRx Team with our thin-film freezing technology."

    About VIP in COVID-19

    Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970, for whom ZYESAMI™ is named. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 500 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type II cell (ATII), that is critical in the production of lung surfactant that is essential to transmission of oxygen from the air to the blood by the pulmonary epithelial cells that line the air sacs (alveoli) of the lung. Initial radiographic changes in Covid-19 are suggestive of collapse of these alveoli.

    Covid-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. The ATII cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. These specialized cells manufacture surfactant that coats the lung and is essential for oxygen exchange. Loss of surfactant causes collapse of the air sacs (alveolae) in the lung and results in respiratory failure.

    VIP is shown to block Coronavirus replication in the ATII cell, block cytokine synthesis, block viral-induced cell death (cytopathy), and upregulate surfactant production. To our knowledge, other than ZYESAMI™, no currently proposed treatments for Covid-19 specifically target these vulnerable Type II cells. Recent laboratory findings suggest that VIP directly interferes with the spike protein complex of the SARS-CoV-2 virus.

    About NeuroRx, Inc. 

    NeuroRx draws upon more than 100 years of collective drug development experience from senior executives of AstraZeneca, Eli Lilly, Novartis, Pfizer, and PPD. In addition to its work on ZYESAMI™, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression and is currently in Phase 3 trials. Its executive team is led by Prof. Jonathan C. Javitt, M.D., M.P.H., who has served as a health advisor to four Presidential administrations and worked on paradigm-changing drug development projects for Merck, Allergan, Pharmacia, Pfizer, Novartis and MannKind, together with Robert Besthof, MIM, who served as the Global Vice President (Commercial) for Pfizer's Neuroscience and Pain Division. NeuroRx recently announced a plan to complete a business combination with Big Rock Partners Acquisition Corp (NASDAQ:BRPA) ("BRPA") and intends to apply for listing on the NASDAQ under the proposed symbol "NRXP". For more information, visit www.neurorxpharma.com.

    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 a potential its dry powder version of NeuroRx's ZYESAMI. 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 NeuroRx and the Company may not be able to produce a dry powder version NeuroRx's ZYESAMI, (ii) the risk that NeuroRx and the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of a dry powder version of NeuroRx's ZYESAM, (iii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, and (iv) 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.

    Corporate Contacts

    NeuroRx, Inc.

    Jonathan C. Javitt, M.D., MPH

    Chairman and Chief Executive Officer

    ceo@neurorxpharma.com

    Media Contact:

    NeuroRx (US):

    David Schull

    Russo Partners, LLC

    David.schull@russopartnersllc.com

    858.717.2310

    Investor Relations:

    NeuroRx (US):

    Brian Korb

    Solebury Trout

    bkorb@troutgroup.com

    917.653.5122

    TFF Contacts:

    Glenn Mattes

    President and CEO

    TFF Pharmaceuticals, Inc.

    gmattes@tffpharma.com

    737-802-1973

    Kirk Coleman

    Chief Financial Officer

    TFF Pharmaceuticals, Inc.

    kcoleman@tffpharma.com

    817-989-6358

    Investor Relations and Media Contact:

    Paul Sagan

    LaVoieHealthScience

    psagan@lavoiehealthscience.com

    617-953-4779

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/neurorx-and-tff-pharmaceuticals-announce-entering-into-feasibility-collaboration-301243563.html

    SOURCE NeuroRx; TFF Pharmaceuticals

    View Full Article Hide Full Article
  17. Feasibility work underway to determine the compatibility of NeuroRx's ZYESAMI™ (aviptadil, synthetic VIP) as a dry powder formulation using TFF's Thin-Film Freezing technology

    Dry powder inhalation technology has the potential to deliver ZYESAMI directly to the lungs

    NeuroRx, Inc. and TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) are announcing that the companies have entered into a feasibility and material transfer agreement (Feasibility Agreement). Under the Feasibility Agreement, NeuroRx is delivering ZYESAMI™ (aviptadil, synthetic VIP) materials to TFF in order to perform feasibility formulation work and testing. The goal of this feasibility work is to formulate and identify an optimal, long-term stable formulation of ZYESAMI™ into a dry powder…

    Feasibility work underway to determine the compatibility of NeuroRx's ZYESAMI™ (aviptadil, synthetic VIP) as a dry powder formulation using TFF's Thin-Film Freezing technology

    Dry powder inhalation technology has the potential to deliver ZYESAMI directly to the lungs

    NeuroRx, Inc. and TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) are announcing that the companies have entered into a feasibility and material transfer agreement (Feasibility Agreement). Under the Feasibility Agreement, NeuroRx is delivering ZYESAMI™ (aviptadil, synthetic VIP) materials to TFF in order to perform feasibility formulation work and testing. The goal of this feasibility work is to formulate and identify an optimal, long-term stable formulation of ZYESAMI™ into a dry powder form, which has superior aerosol properties for delivery directly to the lungs.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210309005660/en/

    ZYESAMI is a synthetic form of a naturally occurring peptide found in the lung called Vasoactive Intestinal Peptide (VIP), which is known to protect the Alveolar Type II cell that is targeted by the SARS-CoV-2 virus. The symptoms of COVID-19 are attributable to decreased surfactant production and increased cytokine production caused by Coronavirus infection of the Type II cell. This may also be a common pathway in sepsis-induced Acute Respiratory Distress Syndrome (ARDS) and Checkpoint Inhibitor induced pneumonitis associated with certain cancer drugs.

    Loss of surfactant production in the lung may be the direct cause of the profound hypoxia or respiratory failure seen in COVID-19. The ability to deliver VIP directly to the lung via inhalation could have important therapeutic implications and potentially broaden the application of the drug to patients less severely affected with COVID-19.

    "We are excited that ZYESAMI has demonstrated a highly significant reduction in time to hospital discharge for seriously ill COVID-19 patients treated with High Flow Nasal Oxygen, along with an increased likelihood of recovery and excellent safety," said Jonathan C. Javitt, M.D., M.P.H., CEO of NeuroRx. "Although our current production methods yield a drug that is sufficiently stable for emergency use, a long-term, shelf-stable formulation will be needed for ongoing use of ZYESAMI, once the pandemic subsides. The thin-film freezing technology holds great promise in potentially making this available to patients with other stages of COVID-19 with an inhaled form of ZYESAMI."

    "The work being done by the NeuroRx team with ZYESAMI on behalf of critically ill patients with COVID-19 respiratory failure is both remarkable and gratifying," said Glenn Mattes, President & CEO of TFF Pharmaceuticals. "The potential opportunity to bring this important new therapeutic to patients earlier in the treatment cycle is exciting. We are very pleased to be collaborating with the NeuroRx Team with our thin-film freezing technology."

    About VIP in COVID-19

    Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970, for whom ZYESAMI™ is named. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 500 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type II cell (ATII), that is critical in the production of lung surfactant that is essential to transmission of oxygen from the air to the blood by the pulmonary epithelial cells that line the air sacs (alveoli) of the lung. Initial radiographic changes in COVID-19 are suggestive of collapse of these alveoli.

    COVID-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. The ATII cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. These specialized cells manufacture surfactant that coats the lung and is essential for oxygen exchange. Loss of surfactant causes collapse of the air sacs (alveolae) in the lung and results in respiratory failure.

    VIP is shown to block Coronavirus replication in the ATII cell, block cytokine synthesis, block viral-induced cell death (cytopathy), and upregulate surfactant production. To our knowledge, other than ZYESAMI™, no currently proposed treatments for COVID-19 specifically target these vulnerable Type II cells. Recent laboratory findings suggest that VIP directly interferes with the spike protein complex of the SARS-CoV-2 virus.

    About NeuroRx, Inc.

    NeuroRx draws upon more than 100 years of collective drug development experience from senior executives of AstraZeneca, Eli Lilly, Novartis, Pfizer, and PPD. In addition to its work on ZYESAMI™, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression and is currently in Phase 3 trials. Its executive team is led by Prof. Jonathan C. Javitt, M.D., M.P.H., who has served as a health advisor to four Presidential administrations and worked on paradigm-changing drug development projects for Merck, Allergan, Pharmacia, Pfizer, Novartis and MannKind, together with Robert Besthof, MIM, who served as the Global Vice President (Commercial) for Pfizer's Neuroscience and Pain Division. NeuroRx recently announced a plan to complete a business combination with Big Rock Partners Acquisition Corp (NASDAQ:BRPA) ("BRPA") and intends to apply for listing on the NASDAQ under the proposed symbol "NRXP". For more information, visit www.neurorxpharma.com.

    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.

    Cautionary Note Regarding Forward Looking Statements – TFF Pharmaceuticals:

    This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company's TFF platform and a potential its dry powder version of NeuroRx's ZYESAMI. 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 NeuroRx and the Company may not be able to produce a dry powder version NeuroRx's ZYESAMI, (ii) the risk that NeuroRx and the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of a dry powder version of NeuroRx's ZYESAM, (iii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, and (iv) 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.

    Cautionary Note Regarding Forward Looking Statements – NeuroRx:

    Statements contained in this press release that are not historical facts may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally relate to future events or NeuroRx's future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these words or other similar terms or expressions that concern NeuroRx's expectations, strategy, plans or intentions. Such forward-looking statements may relate to, among other things, the outcome of any discussions or applications for the future use of ZYESAMI, the approvals, timing, and ability to complete the proposed business combination with BRPA, and the combined company's ability to continue listing on Nasdaq after closing the proposed business combination. Such forward-looking statements do not constitute guarantees of future performance and are subject to a variety of risks and uncertainties. NeuroRx does not undertake any obligation to update forward-looking statements as a result of new information, future events or developments or otherwise.

    Additional Information and Where to Find It

    This press release relates to a proposed business combination and related transactions (the "Transactions") between NeuroRx and BRPA. This press release does not constitute an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. BRPA has filed a registration statement on Form S-4 ("Registration Statement"), which includes a preliminary proxy statement for the solicitation of the approval of BRPA's stockholders, a preliminary prospectus for the offer and sale of BRPA's securities in the Transactions and a preliminary consent solicitation statement of NeuroRx, and other relevant documents with the SEC. The proxy statement/prospectus/consent solicitation statement will be mailed to stockholders of NeuroRx and BRPA as of a record date to be established for voting on the proposed business combination. INVESTORS AND SECURITY HOLDERS OF NEURORX AND BRPA ARE URGED TO READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS/CONSENT SOLICITATION STATEMENT AND OTHER RELEVANT DOCUMENTS THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS. Investors and security holders will be able to obtain free copies of the registration statement, proxy statement, prospectus and other documents containing important information about NeuroRx and BRPA once such documents are filed with the SEC, through the website maintained by the SEC at http://www.sec.gov. In addition, copies of the documents filed with the SEC by BRPA can be obtained free of charge on BRPA's website at www.bigrockpartners.com or by directing a written request to BRPA at 2645 N. Federal Highway, Suite 230 Delray Beach, FL 33483.

    Participants in the Solicitation

    NeuroRx, BRPA and their respective directors and executive officers, under SEC rules, may be deemed to be participants in the solicitation of proxies of BRPA's stockholders in connection with the proposed Transactions. Investors and securityholders may obtain more detailed information regarding the names and interests in the proposed Transactions of NeuroRx's and BRPA's respective directors and officers in BRPA's filings with the SEC, including the proxy statement/consent solicitation statement/prospectus statement. You may obtain a free copy of these documents as described in the preceding paragraph.

    View Full Article Hide Full Article
  18. Feasibility arrangement to test GreenLight Bioscience Inc's COVID-19 messenger RNA vaccine candidate as a shelf-stable dry powder formulation using TFF Pharmaceuticals' Thin-Film Freezing technology.

    An easily reconstituted and shelf-stable dry powder formulation of messenger RNA COVID-19 vaccine could overcome the extreme low temperature cold chain requirements for current RNA vaccines.

    Eliminating extreme cold from the supply chain simplifies global distribution and opens vaccine availability to the large populations in regions and countries with limited refrigeration infrastructure

    Should the study prove successful, the next phase may include non-needle administration of mRNA vaccines, including nasal spray and lung inhalation form.

    Feasibility arrangement to test GreenLight Bioscience Inc's COVID-19 messenger RNA vaccine candidate as a shelf-stable dry powder formulation using TFF Pharmaceuticals' Thin-Film Freezing technology.

    An easily reconstituted and shelf-stable dry powder formulation of messenger RNA COVID-19 vaccine could overcome the extreme low temperature cold chain requirements for current RNA vaccines.

    Eliminating extreme cold from the supply chain simplifies global distribution and opens vaccine availability to the large populations in regions and countries with limited refrigeration infrastructure

    Should the study prove successful, the next phase may include non-needle administration of mRNA vaccines, including nasal spray and lung inhalation form.

    GreenLight Biosciences, Inc., a privately-held RNA vaccine developer and manufacturer, 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 the two biotech companies have partnered for feasibility studies aimed at opening broader global vaccine distribution through production of a shelf-stable powder form of messenger RNA COVID-19 vaccine that would be easily reconstituted prior to injection and not require the extreme cold chain of current RNA vaccines.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210309005642/en/

    While messenger RNA COVID-19 vaccines have proved among the fastest to develop, produce and adapt to new variants of concern, maintaining stability has required supply chain temperatures for some vaccines as low as -80°C (-112°F).

    This requirement for extreme cold increases distribution complexity, cost and also constrains vaccine distribution to regions and countries with limited cold chain infrastructure.

    To address this challenge, GreenLight Biosciences and TFF Pharmaceuticals have entered into a feasibility and material transfer agreement to evaluate a shelf-stable dry powder formulation of GreenLight's COVID-19 messenger RNA vaccine candidate.

    "We are excited to partner with GreenLight Biosciences on their unique messenger RNA production platform," said Glenn Mattes, President & CEO of TFF Pharmaceuticals. "Their platform technology represents a breakthrough in efficient production of messenger RNA vaccines, and by combining both of our technologies, this collaboration could be a real game changer for people around the world suffering through this pandemic."

    Should the feasibility study prove successful, a further stage of work will include non-needle administration methods for the GreenLight mRNA vaccine candidate in a dry powder form that could be administered via nasal spray or lung inhalation.

    Under the Feasibility Agreement, GreenLight Biosciences is delivering its COVID-19 messenger RNA product candidate materials to TFF in order to perform feasibility formulation work and testing.

    The goal of this feasibility work is to formulate and identify an optimal formulation of the GreenLight Biosciences messenger RNA product candidate in a dry powder form, which has superior stability, maintains particle size of the encapsulated messenger RNA as well as high encapsulation efficiency and has rapid reconstitution characteristics for injection.

    If successful, this should make messenger RNA vaccines available to the whole world, simplifying cold-chain supply challenges. Thin film technology potentially allows vaccines to be transported at fridge, or even room temperatures as a powder. It can then be reconstituted by a health care worker at the point of use.

    This agreement is part of GreenLight Biosciences goal of using its unique manufacturing platform to produce vaccines in volumes that can serve the world's need for billions of doses. This partnership offers the hope of speeding these doses into use.

    "Overcoming the COVID-19 pandemic requires a large volume of second generation vaccines that adapt rapidly and can be delivered to all parts of the world, regardless of local cold chain infrastructure," said Andrey J. Zarur, Ph.D, CEO of GreenLight Biosciences. "Thin Film Freezing has the potential to deliver on this promise by reformulating the complex messenger RNA molecules of our vaccine candidate into a shelf-stable powder readily reconstituted by a healthcare worker just prior to injection."

    TFF has two drug candidates in phase one clinical trials, Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder. TFF requires approximately six weeks from receipt of materials to prepare an initial dry powder form of GreenLight's vaccine candidate to test for reconstitutability and viability.

    About GreenLight Biosciences, Inc.

    GreenLight Biosciences has several messenger RNA Covid vaccine candidates in development built off of GreenLight's manufacturing platform, which delivers high-quality RNA at a lower cost and higher speed than comparable processes.

    GreenLight is a bio-performance company with a unique, cell-free production platform that delivers high-performing RNA solutions to human, plant and animal challenges. GreenLight develops RNA products for plant and life science applications, and collaborates with industry leaders to advance vaccine development, pandemic preparation, crop management, and plant protection. The GreenLight team is committed to social justice, diversity, inclusion, and equality, and promises to use collaboration to remain scientifically imaginative and passionately focused on making a difference in the world. For more information, visit https://www.greenlightbiosciences.com/.

    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 TFF platform and its dry powder versions of GreenLight Bioscience Inc's COVID-19 messenger RNA vaccine candidate. 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 GreenLight Bioscience may not be able to successfully conclude clinical testing or obtain pre-market approval of its COVID-19 messenger RNA vaccine candidate, (ii) the risk that GreenLight Bioscience and the Company may not be able to produce a dry powder version GreenLight Bioscience Inc's COVID-19 messenger RNA vaccine candidate, (iii) the risk that GreenLight Bioscience and the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of a dry powder version GreenLight Bioscience Inc's COVID-19 messenger RNA vaccine candidate, (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, and (iv) 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.

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  19. MEDFORD, Mass. and AUSTIN, Texas, March 9, 2021 /PRNewswire/ -- Two biotech companies have partnered for feasibility studies aimed at opening broader global vaccine distribution through production of a shelf-stable powder form of messenger RNA Covid-19 vaccine that would be easily reconstituted prior to injection and not require the extreme cold chain of current RNA vaccines.

    While messenger RNA Covid-19 vaccines have proved among the fastest to develop, produce and adapt to new variants of concern, maintaining stability has required supply chain temperatures for some vaccines as low as -80°C (-112°F).

    This requirement for extreme cold increases distribution complexity, cost and also constrains vaccine distribution to regions and countries…

    MEDFORD, Mass. and AUSTIN, Texas, March 9, 2021 /PRNewswire/ -- Two biotech companies have partnered for feasibility studies aimed at opening broader global vaccine distribution through production of a shelf-stable powder form of messenger RNA Covid-19 vaccine that would be easily reconstituted prior to injection and not require the extreme cold chain of current RNA vaccines.

    While messenger RNA Covid-19 vaccines have proved among the fastest to develop, produce and adapt to new variants of concern, maintaining stability has required supply chain temperatures for some vaccines as low as -80°C (-112°F).

    This requirement for extreme cold increases distribution complexity, cost and also constrains vaccine distribution to regions and countries with limited cold chain infrastructure.

    To address this challenge, GreenLight Biosciences Inc, a privately-held RNA vaccine developer and manufacturer, and TFF Pharmaceuticals, Inc. (NASDAQ:TFFP), have entered into a feasibility and material transfer agreement to evaluate a shelf-stable dry powder formulation of GreenLight's COVID-19 messenger RNA vaccine candidate.

    "We are excited to partner with GreenLight Biosciences on their unique RNA production platform," said Glenn Mattes, President & CEO of TFF Pharmaceuticals. "Their messenger RNA production platform represents a breakthrough in efficient production of messenger RNA vaccines, and by combining both of our technologies, this collaboration could be a real game changer for people around the world suffering through this pandemic."

    Should the feasibility study prove successful, a further stage of work will include non-needle administration methods for the GreenLight mRNA vaccine candidate  in a dry powder form that could be administered via nasal spray or lung inhalation.

    Under the Feasibility Agreement, GreenLight Biosciences is delivering its COVID-19 messenger RNA product candidate materials to TFF in order to perform feasibility formulation work and testing.

    The goal of this feasibility work is to formulate and identify an optimal formulation of the GreenLight Biosciences messenger RNA product candidate in a dry powder form, which has superior stability, maintains particle size of the encapsulated messenger RNA as well as high encapsulation efficiency and has rapid reconstitution characteristics for injection.

    If successful, this should make messenger RNA vaccines available to the whole world simplifying cold chain supply challenges. Thin film technology potentially allows vaccines to be transported at fridge, or even room, temperatures as a powder. It can then be reconstituted by a health care worker at the point of use.

    This agreement is part of GreenLight Biosciences goal of using its unique manufacturing platform to produce vaccines in volumes that can serve the world's need for billions of doses. This partnership offers the hope of speeding these doses into use.

    "Overcoming the COVID-19 pandemic requires a large volume of second generation vaccines that adapt rapidly and can be delivered to all parts of the world, regardless of local cold chain infrastructure," said Andrey J. Zarur, Ph.D, CEO of GreenLight Biosciences. "Thin Film Freezing has the potential to deliver on this promise by reformulating the complex messenger RNA molecules of our vaccine candidate into a shelf-stable powder readily reconstituted by a healthcare worker just prior to injection."

    TFF has two candidates in phase one clinical trials, Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder. TFF requires about six weeks from receipt of materials to prepare an initial dry powder form of GreenLight's vaccine candidate to test for reconstitutability and viability.

    About GreenLight Biosciences, Inc.

    GreenLight Biosciences has several messenger RNA Covid vaccine candidates in development,  are built off of GreenLight's manufacturing platform, which delivers high-quality RNA at a lower cost and higher speed than comparable processes.

    GreenLight is a bio-performance company with a unique, cell-free production platform that delivers high-performing RNA solutions to human, plant and animal challenges. GreenLight develops RNA products for plant and life science applications, and collaborates with industry leaders to advance vaccine development, pandemic preparation, crop management, and plant protection. The GreenLight team is committed to social justice, diversity, inclusion, and equality, and promises to use collaboration to remain scientifically imaginative and passionately focused on making a difference in the world. For more information, visit https://www.greenlightbiosciences.com/.

    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 GreenLight Bioscience Inc's COVID-19 messenger RNA vaccine candidate. 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 GreenLight Bioscience may not be able to successfully conclude clinical testing or obtain pre-market approval of its  COVID-19 messenger RNA vaccine candidate, (ii) the risk that  GreenLight Bioscience and the Company may not be able to produce a dry powder version GreenLight Bioscience Inc's COVID-19 messenger RNA vaccine candidate, (iii) the risk that GreenLight Bioscience and the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of a dry powder version GreenLight Bioscience Inc's COVID-19 messenger RNA vaccine candidate, (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, and (iv) 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.

    Cision View original content:http://www.prnewswire.com/news-releases/feasibility-arrangement-for-shelf-stable-powder-form-of-messenger-rna-covid-19-vaccine-candidate-announced-by-greenlight-biosciences-and-tff-pharmaceuticals-301243041.html

    SOURCE GreenLight Biosciences, Inc.

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  20. On-demand presentations scheduled at H.C. Wainwright Global Life Sciences Conference and 33rd Annual ROTH Conference

    Live panel discussion scheduled for March 15th at 12pm 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, will participate in the H.C. Wainwright Global Life Sciences Conference and the 33rd Annual ROTH Conference, held virtually on March 9-10, 2021, and March 15-17, 2021, respectively.

    Glenn Mattes, President & CEO of TFF Pharmaceuticals, is scheduled to give a pre-recorded company presentation at both virtual conferences.

    Additionally, Dr. Dale Christensen…

    On-demand presentations scheduled at H.C. Wainwright Global Life Sciences Conference and 33rd Annual ROTH Conference

    Live panel discussion scheduled for March 15th at 12pm 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, will participate in the H.C. Wainwright Global Life Sciences Conference and the 33rd Annual ROTH Conference, held virtually on March 9-10, 2021, and March 15-17, 2021, respectively.

    Glenn Mattes, President & CEO of TFF Pharmaceuticals, is scheduled to give a pre-recorded company presentation at both virtual conferences.

    Additionally, Dr. Dale Christensen, Director of Clinical Development at TFF Pharmaceuticals, will participate in a panel discussion at the ROTH Conference on March 15th at 12pm ET. The discussion, titled Therapeutics Against SARS-CoV-2 – Viral Variants Will Not Fade Away, will be led by Dr. Jonathan Aschoff, Managing Director and Senior Research Analyst at ROTH, and Dr. Christensen will be joined by other leading researchers in the industry.

    Recordings of the presentations will be available on-demand to registered conference attendees 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 at both events.

    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.

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  21. Phase 1 clinical study report for Voriconazole Inhalation Powder indicated no treatment emergent adverse events at peak plasma levels for Invasive Pulmonary Aspergillosis

    Phase 1 Single Ascending Dose study of Tacrolimus Inhalation Powder met and exceeded therapeutic drug levels with a single dose with no significant adverse events reported

    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 provided an update on the clinical development progress of its Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder products.

    Voriconazole Inhalation Powder

    The Phase…

    Phase 1 clinical study report for Voriconazole Inhalation Powder indicated no treatment emergent adverse events at peak plasma levels for Invasive Pulmonary Aspergillosis

    Phase 1 Single Ascending Dose study of Tacrolimus Inhalation Powder met and exceeded therapeutic drug levels with a single dose with no significant adverse events reported

    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 provided an update on the clinical development progress of its Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder products.

    Voriconazole Inhalation Powder

    The Phase 1 clinical trial of Voriconazole Inhalation Powder for the treatment of invasive pulmonary aspergillosis (IPA), an inhaled dry powder version of voriconazole, has been successfully completed and comprehensive safety and pharmacokinetic data is now available following delivery of the clinical study report. 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 also associated with significant drug-drug interactions and toxicities.

    Through completion of the Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts, TFF demonstrated that doses of 10, 20, 40, and 80 mg could be delivered twice daily using a dry powder inhaler device with no significant adverse events. There was no evidence of treatment-related or dose-related trends in the reporting of treatment emergent adverse events, throughout the study. No subjects experienced any dose limiting toxicity events during the study.

    "This Phase 1 clinical trial safety data has dramatically exceeded our expectations for Voriconazole Inhalation Powder," stated Glenn Mattes President and CEO of TFF Pharmaceuticals, "The ability to reach blood levels greater than two-fold higher than those shown to clear complex IPA infections provides confidence that dosing patients with the 80 mg dose has a high probability of efficacy without adverse events, and could establish our product as the leading therapy for IPA."

    Voriconazole Inhalation Powder is being developed by TFF to treat IPA with the goal of enhancing efficacy through more efficient delivery of the drug to the lung relative to the oral or intravenous forms of Vfend®, where blood levels can reach greater than 5,000 ng/mL in order to deliver sufficient voriconazole to the lung. However, drug levels greater than 5,000 ng/mL in the blood are associated with severe adverse events including liver kidney and visual toxicities.

    Evaluation of the pharmacokinetic profile of the Voriconazole Inhalation Powder demonstrated that mean peak plasma voriconazole levels reached concentrations of 227 ng/mL following repeated dosing at 80 mg twice daily for 7 days, without any reports of adverse events.

    "Now that we have the final data from this Phase I trial, we have confidently selected the 80 mg dose of Voriconazole Inhalation Powder for our upcoming pivotal trial, where we will be comparing it to the oral form of voriconazole," said Mattes. "We expect to continue to see a more favorable adverse events profile in the inhalable arm, and equal to or greater efficacy when compared to oral voriconazole."

    "We're excited for the future development of Voriconazole Inhalation Powder because we feel it can achieve our target product profile of having better efficacy than oral voriconazole by delivering a greater amount of drug directly to the site of the infection, and of having fewer adverse effects than voriconazole that is dosed systemically to achieve drug levels able to reach the lung," said Mattes.

    In addition to the release of the final data from the Phase 1 clinical trial, TFF is continuing to enroll asthma patients in a Phase 1b study to understand if the Voriconazole Inhalation Powder is likely to trigger bronchospasm in patients with hyperreactive airway disease. Other inhaled anti-infective drugs have demonstrated this effect and require pretreatment with a bronchodilator prior to dosing. TFF is completing this reactive airway study to guide the clinical practice in patients with hyperreactive airway diseases (Asthma and COPD). The data from this study and from the completed healthy normal Phase 1 study will lead to the initiation of a pivotal study of Voriconazole Inhalation Powder, which will begin enrolling patients later this year.

    Tacrolimus Inhalation Powder

    TFF Pharmaceuticals also reports that dosing of the Single Ascending Dose portion of the Phase 1 study of Tacrolimus Inhalation Powder has been successfully completed and the Multiple Ascending Dose portion is ongoing. The SAD portion of the study indicated that TFF's Tacrolimus Inhalation Powder was able to reach therapeutic blood levels of 5-16 ng/mL in all patients from a single inhaled dose of 5 mg of Tacrolimus Inhalation Powder, without significant adverse events.

    "The ability to efficiently reach therapeutic drug levels with our Tacrolimus Inhalation Powder following just a single dose without any significant adverse events is very significant and ahead of our expectations," said Mattes. "Achieving therapeutic blood levels efficiently, with low doses of the inhaled powder, suggests that our product may have application beyond lung transplant, potentially in heart, kidney and liver transplant patients."

    In clinical practice, tacrolimus blood levels are monitored and controlled to achieve blood levels that are known to be associated with efficacious immunosuppression, while not elevating the blood concentration to levels associated with toxicities. For lung transplant patients, therapeutic drug monitoring (TDM) is used to achieve maintenance tacrolimus levels from 5-15 ng/mL after transplant to prevent acute allograft rejection1. The Phase 1 study of Tacrolimus Inhalation Powder utilized TDM measurements to determine when a sufficient dose level had been reached.

    "We look forward to the additional safety and pharmacokinetic data that will be produced during the dosing of the remaining MAD cohorts as we complete this study and prepare for pivotal trials of this promising therapy," concluded Mattes. "We expect to have final safety data completed by the end of the second quarter of 2021, enabling us to move into the pivotal trial phase in the second half of the year."

    1

    Immunosuppression in lung transplantation

    Jenna L. Scheffert, Kashif Raza

    J Thorac Dis. 2014 Aug; 6(8): 1039–1053. doi: 10.3978/j.issn.2072-1439.2014.04.23

    PMCID: PMC4133546

    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 or 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 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.

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  22. 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.

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  23. 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.

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  24. 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.

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  25. 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.

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  26. 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.

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  27. Corporate presentation and live webcast scheduled for Thursday, November 19, 2020 at 2:55 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, has been invited to present at the Jefferies Virtual London Healthcare Conference, taking place virtually from November 17-19, 2020.

    Glenn Mattes, President & CEO of TFF Pharmaceuticals, is scheduled to give a corporate overview on Thursday, November 19, 2020 at 2:55 PM ET, and will participate in one-on-one partnering meetings with investors and other conference attendees.

    A live webcast of the presentation will be available at…

    Corporate presentation and live webcast scheduled for Thursday, November 19, 2020 at 2:55 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, has been invited to present at the Jefferies Virtual London Healthcare Conference, taking place virtually from November 17-19, 2020.

    Glenn Mattes, President & CEO of TFF Pharmaceuticals, is scheduled to give a corporate overview on Thursday, November 19, 2020 at 2:55 PM ET, and will participate in one-on-one partnering meetings with investors and other conference attendees.

    A live webcast of the presentation will be available at the following link: https://wsw.com/webcast/jeff141/tffp/1846800. Following the conference, an archived version of the webcast will be available under the Events Calendar tab in the Investors section of the Company's website.

    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.

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  28. Signs Letter of Intent with Felix Biotechnology to license Thin Film Freezing technology for their bacteriophage products for lung inhalation

    Signs worldwide co-development agreement with Augmenta Bioworks for monoclonal antibody therapeutics

    Reports positive preclinical immunogenicity and efficacy for dry powder universal influenza formulation in collaboration with the University of Georgia

    Reports positive Phase I initial efficacy data on Tacrolimus Inhalation Powder; Voriconazole Inhalation Powder program progresses to Phase II trial

    Conference call and live webcast scheduled today, Thursday, November 5, 2020 at 4:30pm ET

    TFF Pharmaceuticals, Inc. (NASDAQ:TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing…

    Signs Letter of Intent with Felix Biotechnology to license Thin Film Freezing technology for their bacteriophage products for lung inhalation

    Signs worldwide co-development agreement with Augmenta Bioworks for monoclonal antibody therapeutics

    Reports positive preclinical immunogenicity and efficacy for dry powder universal influenza formulation in collaboration with the University of Georgia

    Reports positive Phase I initial efficacy data on Tacrolimus Inhalation Powder; Voriconazole Inhalation Powder program progresses to Phase II trial

    Conference call and live webcast scheduled today, Thursday, November 5, 2020 at 4:30pm 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 reported financial results for the third quarter ended September 30, 2020, as well as provided a business update on recent corporate and clinical developments. The Company will discuss its clinical, corporate and financial highlights on a conference call and live webcast, scheduled today, Thursday, November 5, 2020 at 4:30pm ET.

    "This has been another quarter of strong clinical progress and exceptional partnering activity for TFF Pharmaceuticals, further validating the dual-track business model we've established for the company, and demonstrating the technological capability and market potential of our Thin Film Freezing platform," said Glenn Mattes, President and CEO of TFF Pharmaceuticals.

    "The two new agreements recently announced with Felix Biotechnology and Augmenta Bioworks represent the potential first-of-their-kind dry powder inhalation reformulations of bacteriophages and monoclonal antibodies, respectively," said Mattes. "This is the culmination of months of work by our scientific staff to take large, complex biologics and reformulate them for better efficacy, delivery and storage characteristics, thus enhancing their therapeutic value and market potential."

    "Our ongoing work with the University of Georgia has successfully reformulated, for the first time, a potential universal flu vaccine into a dry powder for inhalation. This reformulation suggests immunogenicity and efficacy equivalent to liquid formulations, and could allow this protein vaccine to be more stable and long-lasting - removing logistical cold chain challenges that could limit the eventual distribution of a universal flu vaccine," said Mattes.

    "Our three internal development programs continue to advance in the clinic," continued Mattes. "Our lead clinical program, Voriconazole Inhalation Powder, the first clinical study ever in healthy subjects of a direct-to-lung, dry-powder formulation for the treatment of Invasive Pulmonary Aspergillosis (IPA) successfully completed Phase 1 dosing and will enter Phase 2 trials."

    "Our second clinical trial program, the Phase 1 dosing of healthy subjects of Tacrolimus Inhalation Powder, an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection, has shown no clinically significant drug-associated adverse events, while achieving substantial immunosuppressive blood levels," said Mattes. "And finally, our niclosamide program is on track and we are moving forward with both the oral and inhaled versions."

    "This quarter, we also took important steps to expand our manufacturing capacity to develop and produce products currently in assessment with pharmaceutical company partners, and give us a secure third source for Thin Film Freezing dry powder inhalation products," continued Mattes.

    "Despite the ongoing effects of the global pandemic, we continue to execute on our core strategies, thanks to the incredible efforts of our scientists, staff and business partners," concluded Mattes. "We are excited to further progress with our breakthrough TFF platform technology and we look forward to reporting on new developments in upcoming quarters."

    Conference Call and Webcast Information

    The Company will host a conference call today, Thursday, November 5, 2020, at 4:30 pm, Eastern Time, to review their clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

    U.S. Dial-In Number: Toll-Free: (877) 784-1702

    International Dial-In Number (857) 770-0110

    Conference ID: 9498042

    The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals' website, https://tffpharma.com or directly at https://edge.media-server.com/mmc/p/wiw3v2y6. Please access the Company's website 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 in the Events Calendar of the Investors section.

    Recent Corporate and Clinical Highlights:

    • Letter of Intent with Felix Biotechnology: On November 5, TFF announced signing a Letter of Intent with Felix Biotechnology, Inc of San Francisco reflecting the non-binding agreement in principle of the parties to negotiate and enter into a Collaboration, Development and License Agreement. Under the proposed agreement, Felix Biotechnology will obtain a non-exclusive license to TFF's thin-film freezing technology to develop and manufacture dry powder formulations of specified Felix bacteriophage products for inhalation delivery directly to the lungs of patients. Felix would agree to pay TFF Pharmaceuticals an upfront payment, development milestones, commercial milestones and royalties on net sales of the Felix phage products. The Letter of Intent is subject to certain conditions, including Felix's completion of its Series A financing.
    • Worldwide Joint Development Agreement with Augmenta Bioworks: On November 2, TFF announced that it had entered into a worldwide joint development and collaboration agreement with Augmenta Bioworks of Menlo Park, CA to develop novel commercial products incorporating Augmenta's human-derived monoclonal antibodies (mAbs) for potential COVID-19 therapeutics. These products will be developed utilizing TFF Pharmaceutical's Thin-Film Freezing technology to manufacture dry powder formulations of these specific mAbs for inhalation delivery directly to the lungs of patients. Under the Agreement, TFF Pharmaceuticals will also have an option to develop an additional Augmenta mAb for indications other than COVID-19.
    • University of Georgia Universal Influenza Vaccines: In October, TFF reported positive preclinical immunogenicity and efficacy data from a UGA-developed universal Influenza hemagglutinin (HA) recombinant vaccine that had been reformulated using the Company's Thin Film Freezing process. The Company reported that this reformulated, dry powder HA vaccine elicited equivalent neutralizing antibodies and protection against influenza virus infection compared to liquid formulations. In April of 2020, TFF Pharmaceuticals and the University of Georgia's Center for Vaccines and Immunology entered into a Research and Development Agreement to test the immunogenicity and efficacy of universal influenza HA recombinant vaccines following the TFF process.
    • Tacrolimus Inhalation Powder: The Company reported successfully completing the single ascending dosing of four cohorts of healthy subjects in its Phase 1 trial of Tacrolimus Inhalation Powder. The dosing completed to date suggests that Tacrolimus Inhalation Powder is well tolerated with no reports of clinically significant drug-associated adverse events and provide substantial systemic blood levels, from just a single dose, that approach those levels associated with effective immunosuppression in heart, lung, kidney and liver transplant patients. Tacrolimus is an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection.
    • Voriconazole Inhalation Powder: TFF's lead clinical program, Voriconazole Inhalation Powder, to treat the severe and life-threatening disease of Invasive Pulmonary Aspergillosis, or IPA, successfully completed the clinical portion of its Phase 1 trial and progressed to Phase 2. Top-line data from the Phase I single ascending dose and multiple ascending dose portions of the trial indicated that when dosed up to 80mg twice daily, Voriconazole Inhalation Powder showed no signs of the clinically significant hepatic or visual toxicities that were previously reported for the oral or intravenous forms of voriconazole. Phase 2 studies will assess the efficacy of the dry powder formulation for the treatment of IPA.
    • COVID-19/SARS-CoV-2 Drug Repurposing Feasibility Projects: TFF is actively reviewing previously FDA approved drugs that may be repurposed to combat the novel coronavirus behind the COVID-19 pandemic outbreak. The Company is reviewing libraries of compounds that could potentially benefit from the characteristics of the TFF technology in developing a dry powder product delivered directly to the lung that is capable of targeting SARS-CoV-2 and potentially similar viruses such as SARS-CoV, MERS-CoV and other endemic coronaviruses.



      During the quarter, the inventor of the Company's TFF technology, Dr. Robert O. (Bill) Williams III, published new animal pharmacokinetics data evaluating the development of remdesivir as a dry powder for inhalation by Thin Film Freezing. Top-line results of the study conducted by Dr. Williams' team of researchers at the University of Texas at Austin's Division of Molecular Pharmaceutics and Drug Delivery, concluded that TFF technology can produce high potency remdesivir dry powder formulations for inhalation suitable to treat patients with COVID-19 on an outpatient basis and earlier in the disease course where effective antiviral therapy can reduce related morbidity and mortality.
    • Worldwide Licensing Agreement with UNION Therapeutics: As announced previously during the quarter, on August 12, 2020, the Company signed a worldwide exclusive licensing agreement with UNION Therapeutics for its Thin Film Freezing technology used in combination with niclosamide.
    • Private Financing Round: As announced previously on August 13, 2020, the Company closed on a private placement of up to $25,913,550, before deducting placement agent and other offering expenses, of common shares of the Company. Net proceeds from the financing are being used to accelerate the expansion of the Company's internal development portfolio beyond its programs for Voriconazole and Tacrolimus inhalation powders.

    Financial Results

    For the nine months ended September 30, 2020, compared to the prior year

    • Research and Development (R&D) expenses: R&D expenses for the nine months ended September 30, 2020 were $7.6 million, compared to $5.6 million for the same period in 2019.
    • General & Administrative (G&A) expenses: G&A expenses for the nine months ended September 30, 2020 were $5.1 million, compared to $1.7 million for the same period of 2019.
    • Net Loss: TFF Pharmaceuticals reported a net loss for the nine months ended September 30, 2020 of $12.7 million, compared to a net loss of $7.2 million for the same period of 2019.
    • Shares Outstanding: Weighted average common shares outstanding, basic and diluted, for the nine months ended September 30, 2020 were 20,810,004, compared with 4,400,000 for the same period in 2019.
    • Total Assets: As of September 30, 2020, we had total assets of approximately $43.2 million and working capital of approximately $40.6 million. At the end of the quarter, our liquidity included approximately $41.6 million of cash and cash equivalents.
    • Shelf-registration statement on Form S-3: On November 5, TFF Pharmaceuticals filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission for future offerings of up to $100 million of the Company's common stock.

    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 Tacrolimus, the recent agreements with Augmenta Bioworks and Felix Technology, the potential license of our technology to UNION therapeutics 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 Company's product candidates may not be indicative of results obtained in future preclinical or clinical trials; (ii) the risk that the Company's dry powder formulation of its product candidates 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 the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its product candidates; (v) the risk that the Company's agreements with Felix Technology and UNION will not lead to definitive license agreements; (vi) 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; (vii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform; and (viii) 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.

    TFF PHARMACEUTICALS, INC.

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND

    COMPREHENSIVE LOSS

     

     

     

    Three Months

    Ended

    September 30,

    2020

     

     

    Three Months

    Ended

    September 30,

    2019

     

     

    Nine Months

    Ended

    September 30,

    2020

     

     

    Nine Months

    Ended

    September 30,

    2019

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    2,823,669

     

     

    $

    2,563,528

     

     

    $

    7,626,982

     

     

    $

    5,554,046

     

    General and administrative

     

     

    2,254,912

     

     

     

    300,640

     

     

     

    5,147,639

     

     

     

    1,721,691

     

    Total operating expenses

     

     

    5,078,581

     

     

     

    2,864,168

     

     

     

    12,774,621

     

     

     

    7,275,737

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Loss from operations

     

     

    (5,078,581

    )

     

     

    (2,864,168

    )

     

     

    (12,774,621

    )

     

     

    (7,275,737

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Other income:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income

     

     

    20,546

     

     

     

    25,865

     

     

     

    102,809

     

     

     

    67,699

     

    Total other income

     

     

    20,546

     

     

     

    25,865

     

     

     

    102,809

     

     

     

    67,699

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss

     

     

    (5,058,035

    )

     

     

    (2,838,303

    )

     

     

    (12,671,812

    )

     

     

    (7,208,038

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Preferred stock dividend

     

     

     

     

     

    (258,635

    )

     

     

     

     

     

    (768,876

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss applicable to common stock

     

     

    (5,058,035

    )

     

     

    (3,096,938

    )

     

     

    (12,671,812

    )

     

     

    (7,976,914

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Other comprehensive loss:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Foreign currency translation adjustments

     

     

    (28,172

    )

     

     

     

     

     

    (67,663

    )

     

     

     

    Comprehensive loss

     

    $

    (5,086,207

    )

     

    $

    (3,096,938

    )

     

    $

    (12,739,475

    )

     

    $

    (7,976,914

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss applicable to common stock per share, basic and diluted

     

    $

    (0.24

    )

     

    $

    (0.70

    )

     

    $

    (0.61

    )

     

    $

    (1.81

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Weighted average common shares outstanding, basic and diluted

     

     

    20,867,526

     

     

     

    4,400,000

     

     

     

    20,810,004

     

     

     

    4,400,000

     

    TFF PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

     

     

     

    September 30,

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

     

     

    (Unaudited)

     

     

     

     

    ASSETS

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    41,617,891

     

     

    $

    28,094,936

     

    Prepaid assets and other current assets

     

     

    595,016

     

     

     

    1,092,462

     

    Total current assets

     

     

    42,212,907

     

     

     

    29,187,398

     

    Property and equipment, net

     

     

    945,365

     

     

     

     

    Total assets

     

    $

    43,158,272

     

     

    $

    29,187,398

     

     

     

     

     

     

     

     

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    1,573,384

     

     

    $

    410,638

     

    Total current liabilities

     

     

    1,573,384

     

     

     

    410,638

     

    Accrued research and development expense

     

     

     

     

     

    1,132,013

     

    Total liabilities

     

     

    1,573,384

     

     

     

    1,542,651

     

     

     

     

     

     

     

     

     

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Stockholders' equity:

     

     

     

     

     

     

     

     

    Common stock; $0.001 par value, 45,000,000 shares authorized; 22,226,284 and 18,450,992 shares

    issued and outstanding as of September 30, 2020 and December 31, 2019, respectively

     

     

    22,226

     

     

     

    18,451

     

    Additional paid-in capital

     

     

    70,014,551

     

     

     

    43,338,710

     

    Accumulated other comprehensive loss

     

     

    (67,663

    )

     

     

     

    Accumulated deficit

     

     

    (28,384,226

    )

     

     

    (15,712,414

    )

    Total stockholders' equity

     

     

    41,584,888

     

     

     

    27,644,747

     

    Total liabilities and stockholders' equity

     

    $

    43,158,272

     

     

    $

    29,187,398

     

     

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  29. Felix Biotechnology would obtain worldwide license for Thin Film Freezing technology to develop a novel, bacteriophage-based biotherapeutic

    Proposed terms provide for upfront payments, clinical development milestone and commercial milestone payments to TFF Pharmaceuticals of up to $281 million, as well as negotiated royalty payments

    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, and Felix Biotechnology, Inc., a clinical stage, biotherapeutic-based antibiotic development company, today jointly announce that both companies have entered into a letter of intent (LOI) which…

    Felix Biotechnology would obtain worldwide license for Thin Film Freezing technology to develop a novel, bacteriophage-based biotherapeutic

    Proposed terms provide for upfront payments, clinical development milestone and commercial milestone payments to TFF Pharmaceuticals of up to $281 million, as well as negotiated royalty payments

    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, and Felix Biotechnology, Inc., a clinical stage, biotherapeutic-based antibiotic development company, today jointly announce that both companies have entered into a letter of intent (LOI) which reflects the parties' non-binding agreement in principle to negotiate and enter into a Collaboration, Development and License Agreement (CDLA).

    Under this proposed CDLA agreement, Felix Biotechnology would obtain a worldwide license to TFF Pharmaceuticals' Thin Film Freezing technology to develop and manufacture dry powder formulations of a novel, bacteriophage-based biotherapeutics for inhalation delivery directly to the lungs of patients. Under the terms of the proposed CDLA and in exchange for the license to the TFF technology, Felix would agree to pay TFF Pharmaceuticals an upfront payment, development milestones, commercial milestones and royalties on net sales of the Felix biotherapeutics. A definitive CDLA is subject to the mutual agreement of the parties and a number of conditions, including Felix Biotechnology's successful completion of a Series A financing.

    "We are very excited to be pursuing an agreement with Felix Biotechnology, a company on the leading edge of developing bacteriophage therapies that initially are targeting bacterial lung infections," said Glenn Mattes, President and CEO of TFF Pharmaceuticals. "We believe the reformulation of these unique, complex biologics using our TFF technology would represent a first-of-its-kind breakthrough and could provide a more effective and targeted delivery mechanism to the deep lung of patients. We look forward to working towards a final agreement and seeing this breakthrough technology advance into the clinic and beyond."

    "Our goal at Felix is not only to develop but also to deploy innovative solutions to tackle the growing and unmanaged challenge of antibiotic resistant bacterial infections. We currently deliver our generalized phage therapy directly to the lung via nebulization, and have done so successfully in humans. Our lead asset, targeting Pseudomonas infections in the lungs of CF patients is currently being evaluated in a double-blind, placebo-controlled trial at Yale in 36 patients," said Rob McBride, CEO of Felix Biotechnology. "We are excited to continue developing cutting edge and effective phage delivery solutions to our patients and our collaboration with TFF represents an important next step for us on this path."

    "Bacteriophages, which are bacterial viruses that infect specific strains of a single bacteria species, are highly relevant as therapeutic alternatives to antibiotics because of the prevalence of multidrug resistance to antibiotics," said Robert O. Williams III, Division Head of the University of Texas at Austin's Division of Molecular Pharmaceutics and Drug Delivery and an inventor of TFF Pharmaceutical's Thin Film Freezing technology.

    "The challenge, historically, of delivering bacteriophages is that their formulations have not been well optimized, limiting their shelf-life and subsequent potency. Many of these formulations also require cold-chain storage," continued Williams. "We have demonstrated that Thin Film Freezing can convert liquid bacteriophage into a dry powder that can be stored at typical room temperatures. This dry powder form of the bacteriophage can then be administered by intranasal/inhalation delivery to the lungs, or by injection after reconstitution at the point-of-use."

    In May of 2020, the companies entered into a Feasibility and Material Transfer Agreement under which Felix Biotechnology supplied various phage product materials to TFF Pharmaceuticals for compatibility and feasibility testing. TFF Pharmaceuticals was successful in formulating dry powder formulations of the Felix phage products, which exhibited superior aerosol properties for lung delivery. Based on this successful formulation work and confirmatory in-vitro testing, which included titer testing and neutralization testing, both parties agreed to begin negotiating a licensing arrangement.

    About Felix Biotechnology, Inc.

    Felix Biotechnology is a clinical stage, biotherapeutic-based antibiotic development company with technology from Yale University and UC Berkeley, focused on accelerating the development and deployment of non-traditional biotherapeutic-based antibiotics targeting urgent microbial challenges in patients who can't wait. Their engineering and discovery platforms generate therapies that overcome key limitations of traditional phage therapy approaches (bacterial resistance and phage specificity). This allows for the deployment of generalized phage therapy that kill specific bacterial infections while preserving healthy microbiome function. For more information, please visit our website at https://www.felixbt.com, or follow us on Twitter at https://twitter.com/felixbiotech.

    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 nonbinding letter of intent with Felix Biotechnology, the proposed negotiation and execution of a definitive Collaboration, Development and License Agreement (CDLA), the potential success of the proposed collaboration between TFF and Felix Biotechnology, TFF's potential receipt of milestone and sales-based payments from Felix Biotechnology, the benefits of the Company's TFF platform and its dry powder formulations of niclosamide and other materials, and the Company's plans to add to its existing pipeline of product candidates and license its technology to 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 TFF Pharmaceuticals may not be able to conclude a CDLA with Felix Biotechnology; (ii) if the parties can conclude a CDLA, the risk that results obtained in dry powder formulation and in vitro testing of the Felix phage products may not be indicative of results obtained in future preclinical or clinical trials; (iii) the risk that TFF Pharmaceuticals' dry powder formulation of the Felix phage products may not advance through the preclinical development and clinical trial process on a timely basis, or at all; (iv) 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; (v) the risk that TFF Pharmaceuticals and Felix Biotechnology may not be able to successfully conclude clinical testing or obtain pre-market approval of their dry powder versions of the Felix phage products, , (vi) the risk that few, or none, of the milestone or sales and sales-based payments from Felix Biotechnology will be satisfied and TFF will receive little, or none, of such milestone and sales-based payments, (vii) 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, (viii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, and (ix 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.

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  30. Companies to collaborate in first-of-its-kind uses of Thin Film Freezing technology applied to monoclonal antibodies

    TFF Pharmaceuticals, Inc. (NASDAQ:TFFP), a clinical-stage biopharmaceutical company, and Augmenta Bioworks, Inc., a biotechnology company enabling breakthroughs in medicine through immune profiling, today jointly announce that both companies have entered into 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.

    Under the terms of the Agreement, both companies will collaborate in a Joint Development Project to develop one or more commercial therapeutics based on, derived from, and/or…

    Companies to collaborate in first-of-its-kind uses of Thin Film Freezing technology applied to monoclonal antibodies

    TFF Pharmaceuticals, Inc. (NASDAQ:TFFP), a clinical-stage biopharmaceutical company, and Augmenta Bioworks, Inc., a biotechnology company enabling breakthroughs in medicine through immune profiling, today jointly announce that both companies have entered into 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.

    Under the terms of the Agreement, both companies will collaborate in a Joint Development Project to develop one or more commercial therapeutics based on, derived from, and/or incorporating Augmenta's human monoclonal antibodies to potentially treat patients with COVID-19. These products will be developed utilizing TFF Pharmaceuticals' Thin-Film Freezing technology to manufacture dry powder formulations of these specific mAbs 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. TFF Pharmaceuticals will also have the option to develop two additional Augmenta mAbs for indications other than COVID-19.

    Augmenta Bioworks and TFF Pharmaceuticals will allocate patent license rights to their respective technologies to allow each company to jointly commercialize the products developed under the Joint Development Project. The companies have agreed to a 50-50 split of all costs and expenses to further the Joint Development Project and both companies have agreed to the same 50-50 split of all revenues, cash payments and/or future cash payments related to the sale and/or license of the products resulting from the Joint Development Project to a third party.

    "This important agreement represents the culmination of many months of work by our scientific team, as we work towards the development of a never-before-achieved formulation of monoclonal antibodies into a dry powder therapeutic," said Glenn Mattes, CEO, of TFF Pharmaceuticals, Inc. "It is a testament to the remarkable flexibility and capability of our Thin Film Freezing platform and we are eager to develop these potentially breakthrough mAb therapies internally, along with our other programs in Invasive Pulmonary Aspergillosis, solid organ transplant anti-rejection, and botanicals."

    "Confirmed discovery of novel anti-SARS-Cov-2 antibodies in 8 days was an achievement made possible by years of technology development, and a clear indication of the power and potential of our platform," said Christopher Emig, Ph.D., CEO and Co-Founder of Augmenta Bioworks, Inc. "We are excited to enter this partnership to bring our COVID-19 treatment into clinical development, and are looking forward to the world's first effective, affordable and scalable antibody therapeutic to mitigate the devastating effects of this disease."

    "We believe the interest in monoclonal-antibody therapeutics for the treatment of COVID-19 is extremely high, with the promise that they will harness the immune system's natural response to viral invaders," said Robert O. Williams III, Ph.D., Division Head of the University of Texas at Austin's Division of Molecular Pharmaceutics and Drug Delivery and inventor of TFF Pharmaceuticals' Thin Film Freezing technology.

    "The challenge becomes in the delivery of these very large, complex molecules via injection, which does not reach directly to the initial site of infection - the deep lung area. Liquid injections are also subject to all the attendant difficulties of cold chain handling and storage, potentially limiting their use to only areas in the developed world," continued Williams. "In this collaboration with Augmenta, the first-of-its-kind use of Thin Film Freezing technology applied to monoclonal antibodies has the potential to mitigate both of these challenges and lead to a therapy that is more effective and easier to deliver to a global community."

    In June 2020, the companies entered into a Feasibility and Material Transfer Agreement under which Augmenta Bioworks supplied various mAb product materials to TFF Pharmaceuticals for compatibility and feasibility testing. TFF Pharmaceuticals was successful in formulating dry powder formulations of the Augmenta mAbs, which exhibited superior aerosol properties for lung delivery. Based on this successful formulation work and confirmatory in-vitro testing, which included viability testing, binding testing and neutralization testing, both parties agreed to pool their efforts and resources through a Joint Development Project, and collectively move the dry powder mAb products into pre-clinical and toxicology studies with the goal of further advancement of these dry powder mAbs into human testing in the clinic.

    About Augmenta Bioworks

    Augmenta Bioworks is a venture-backed biotechnology company leveraging immune profiling technologies to enable breakthroughs in medicine. Through its DeepGridTM and SingleCyte® 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' 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 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' 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.

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  31. Company to hold conference call and webcast at 4:30 PM EDT

    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 and business update for the third quarter of 2020 on Thursday, November 5, 2020 at the close of the U.S. financial markets.

    Management will host a conference call to discuss the financial results and provide a business 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:

    Thursday…

    Company to hold conference call and webcast at 4:30 PM EDT

    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 and business update for the third quarter of 2020 on Thursday, November 5, 2020 at the close of the U.S. financial markets.

    Management will host a conference call to discuss the financial results and provide a business 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:

    Thursday, November 5, 2020, 4:30 PM Eastern Time (ET)

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

    International Dial-In Number (857) 770-0110

    Conference ID: 9498042

    Webcast Registration Link: https://edge.media-server.com/mmc/p/wiw3v2y6

    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.

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  32. 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 has expanded its engagement with one of its Contract Manufacturing Organization (CMOs), Experic, LLC, with an agreement to install a Thin Film Freezing processing line and its associated capabilities at Experic's cGMP facility in Cranbury, New Jersey.

    Installation of TFF's custom-designed equipment is expected to be complete in early Q2-2021. This will increase TFF's manufacturing capacity, as well as provide a third cGMP manufacturing location for the company.

    "This expansion of our manufacturing operations…

    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 has expanded its engagement with one of its Contract Manufacturing Organization (CMOs), Experic, LLC, with an agreement to install a Thin Film Freezing processing line and its associated capabilities at Experic's cGMP facility in Cranbury, New Jersey.

    Installation of TFF's custom-designed equipment is expected to be complete in early Q2-2021. This will increase TFF's manufacturing capacity, as well as provide a third cGMP manufacturing location for the company.

    "This expansion of our manufacturing operations at Experic gives us the capability and capacity to develop and produce additional products currently in assessment with pharmaceutical company partners," said Glenn Mattes, President and CEO of TFF Pharmaceuticals. "Experic has been a terrific partner for us because of their domain expertise in dry powder inhalation products. They also provide us with unique downstream encapsulation technology that rounds out the specialized manufacturing requirements of our dry powder inhalation therapies."

    "The entire Experic team is thrilled to be working with TFF Pharmaceuticals and supporting development and manufacturing activities using its Thin Film Freezing (TFF) technology," said Jeffrey P. McMullen, Chairman and CEO of Experic. "We share their excitement in the continued advancement and expansion of their technology and business."

    About Experic Services

    Experic, a contract manufacturing organization (CMO) and pharmaceutical supply services company, supports every phase of a product's life cycle from clinical to commercial scale, across a range of dosing and packaging formats, including capsule filling, powder and pellet dosing (including DPI), and autoinjectors and pen assemblies. Utilizing cutting-edge Harro Höfliger equipment in our state-of-the-art Class A GMP facility and build-to-suit suites, we manage global delivery of the highest quality products, even for expedited projects, while providing unparalleled knowledge, expertise and customer service.

    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 TFF platform and its dry powder versions of Voriconazole and 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 results obtained in preclinical studies and clinical trials may not be indicative of results obtained in future clinical trials; (ii) the risk that the Company's product candidates 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 warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; (iv) 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 and Tacrolimus, (v) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vii) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (viii) 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.

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  33. Company completes dosing of three cohorts with Tacrolimus Inhalation Powder for direct-to-lung delivery of a Thin Film Freezing dry-powder product for prevention of lung transplant rejection

    Single ascending dose cohorts to date shown to be safe with no clinically significant drug-associated adverse events, while achieving substantial immunosuppressive blood levels

    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 has successfully completed the single ascending dosing of three cohorts of healthy subjects for its second clinical program, Tacrolimus Inhalation…

    Company completes dosing of three cohorts with Tacrolimus Inhalation Powder for direct-to-lung delivery of a Thin Film Freezing dry-powder product for prevention of lung transplant rejection

    Single ascending dose cohorts to date shown to be safe with no clinically significant drug-associated adverse events, while achieving substantial immunosuppressive blood levels

    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 has successfully completed the single ascending dosing of three cohorts of healthy subjects for its second clinical program, Tacrolimus Inhalation Powder for the prevention of lung transplant rejection.

    This Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study will assess the safety, tolerability and pharmacokinetics of tacrolimus, an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection. Subjects were dosed at a single site in Australia under the Australian Clinical Trial notification (CTN) process.

    In June 2020, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to Tacrolimus Inhalation Powder for prophylaxis of lung allograft rejection. The ongoing Phase 1 clinical trial of Tacrolimus Inhalation Powder is a randomized, double-blind, placebo-controlled study with an inhalation route of administration to 64 healthy adult volunteers. The study is comprised of two dose escalation phases – a SAD phase with 40 participants, followed by a MAD phase with 24 participants. For the MAD phase, subjects will receive a total of 13 doses over 7 days with doses being administered every 12 hours. The main objectives of the Phase 1 clinical trial are to assess the safety, tolerability and pharmacokinetic profile of the Tacrolimus Inhalation Powder in healthy subjects.

    The Company reports that dosing in the first three cohorts of healthy normal volunteers in the SAD phase of the study were shown to be safe and well tolerated with no reports of clinically significant drug-associated adverse events. Successful completion of the third cohort of the SAD part of the study with no reported safety concerns represents a critical milestone for progression of the study. The final safety data from all five cohorts in the SAD portion of the study will be used to commence the MAD portion of the trial, with dosing of the first cohort in the MAD phase to be initiated soon.

    "We are pleased to report this important progress in our second clinical development program and are excited to see that the dosing completed to date suggests that Tacrolimus Inhalation Powder can be safely administered and provide substantial systemic blood levels, from just a single dose, that approach those levels associated with effective immunosuppression in heart, lung, kidney and liver transplant patients," stated Glenn Mattes, President and CEO of TFF Pharmaceuticals. "The ability to safely delivery tacrolimus by a route that bypasses the gastrointestinal tract could provide for fewer drug-to-drug interactions and could provide for more predictable drug levels, because poor bioavailability and differential metabolism can lead to highly variable drug levels with orally delivered tacrolimus."

    "We believe these data indicate that TFF Tacrolimus has strong potential in not only the current lung transplant indication, but also potential efficacy, safety and survival benefits for heart, liver and kidney transplant patients," concluded Mattes.

    TFF Pharmaceuticals' proprietary Thin Film Freezing technology platform allows the reformulation of Tacrolimus into dry powder particles with properties believed to be ideally suited for inhalation delivery. The Tacrolimus dry powder formulation is currently being developed to prevent lung transplant rejection and if the pharmacokinetics from the ongoing trial indicate that pulmonary delivery provides more predictable blood levels than oral dosing, the Company may pursue developments to prevent rejection in other solid organ transplant procedures.

    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 TFF platform and its dry powder versions of Voriconazole and 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 results obtained in preclinical studies and clinical trials may not be indicative of results obtained in future clinical trials; (ii) the risk that the Company's product candidates 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 warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; (iv) 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 and Tacrolimus, (v) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vii) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (viii) 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.

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  34. 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 results from its Annual Meeting of Stockholders, which took place virtually earlier today. All director nominees were elected to the Board of Directors and Marcum LLP was appointed as the Company's independent registered public accounting firm for the 2020 fiscal year. A total of 18,076,265 common shares (representing approximately 83% of all issued and outstanding common shares of TFF) were represented at the meeting.

    The detailed results of the Annual Meeting were as follows:

    1. Election of Directors

    All…

    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 results from its Annual Meeting of Stockholders, which took place virtually earlier today. All director nominees were elected to the Board of Directors and Marcum LLP was appointed as the Company's independent registered public accounting firm for the 2020 fiscal year. A total of 18,076,265 common shares (representing approximately 83% of all issued and outstanding common shares of TFF) were represented at the meeting.

    The detailed results of the Annual Meeting were as follows:

    1. Election of Directors

    All eight (8) nominees for the Board of Directors that were proposed by TFF's management were elected as a Director of the Company. All the nominated directors were members of the Board of Directors of TFF prior to today's Meeting. The votes were cast for each nominee as follows:

    Nominee

    Yes

    Withheld

    Aaron Fletcher, Ph.D.

    11,253,545

    28,609

    Brian Windsor, Ph.D.

    11,253,543

    28,611

    Stephen C. Rocamboli

    11,253,546

    28,608

    Randy Thurman

    11,253,545

    28,609

    Glenn Mattes

    11,253,543

    28,611

    Robert S. Mills

    11,094,669

    187,485

    Harlan Weisman, M.D.

    11,183,280

    98,874

    Malcolm Fairbairn

    11,253,504

    28,650

    2. Appointment of Auditor

    Marcum LLP was appointed as the Company's independent registered public accounting firm for the 2020 fiscal year. The votes were cast as follows:

    Yes

    No

    Abstain

    18,058,701

    8,545

    9,019

    Virtual Webcast

    Due to recommendations from local authorities and ongoing concerns regarding the spread of the novel coronavirus (COVID-19), TFF held its Annual Meeting entirely by webcast, to prioritize the safety and health of its stockholders, employees and other stakeholders.

    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 the dry powder version of remdesivir 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 be unable to successfully conclude clinical testing or obtain pre-market approval of its dry powder versions of Voriconazole and 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 Registration Statement on Form S-1 filed with the SEC on September 9, 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.

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  35. SAN DIEGO, Sept. 30, 2020 /PRNewswire/ -- IRISYS LLC, a pharmaceutical contract manufacturing and development organization (CDMO), announced its third contract for production and manufacturing in partnership with TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company located in Austin, TX. Most recently, TFF Pharmaceuticals contracted with IRISYS to manufacture an inhalable lung medication with the potential to treat COVID-19.

    A publicly traded company (NASDAQ:TFFP), TFF Pharmaceuticals researches and innovates drug products based on its patented Thin Film Freezing, or TFF, technology platform. This freezing process creates dry powder formulations with properties ideal for inhalation and can potentially target SARS-CoV-2, the disease caused by COVID-19, inside the lungs by delivering medication directly to the infection site. TFF has compounds under development that can be used to treat challenging-to-manage lung conditions such as Invasive Pulmonary Aspergillosis, or IPA, and COVID-19.

    TFF found IRISYS to be a superior partner for the transfer of its technology to IRISYS' labs. IRISYS will be responsible for the initial production and testing of TFF's investigational powder product for inhalation. IRISYS was able to help adapt the process to the needs of the project and to establish a robust manufacturing process suitable for clinical trial materials preparation.

    "The most important part of this project is that we are not just helping develop a new formulation, but a new technology. With the versatility of this process, any lung therapeutic could potentially be applicable," - JJ Sigler, IRISYS Scientist

    The TFF platform was designed to improve solubility of poorly water-soluble drugs generally, and the technology is particularly useful in generating 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 involves dissolving the drug in a solvent system, and then flash freezing the drug substance. The frozen powder is lyophilized, resulting 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 drug deposited to the deep lung has the potential to reach as high as 75%.

    Heather Emerson-Young

    Digital Marketing Strategist

    IRISYS LLC

    hemerson@irisys.com 

    858-281-7920

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/irisys-llc-signs-a-third-contract-with-tff-pharma-to-produce-medication-to-treat-lung-conditions-including-covid-19-301142192.html

    SOURCE IRISYS LLC

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  36. Scientists at the University of Texas at Austin report new pharmacokinetics data from the use of Thin Film Freezing technology to deliver remdesivir through dry powder inhalation

    Dry powder formulation of remdesivir with leucine found to allow more sustained release of remdesivir from lung to plasma

    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 commented on new animal pharmacokinetics data evaluating the development of remdesivir as a dry powder for inhalation by Thin Film Freezing (TFF).

    Top-line results of the study conducted by a team of researchers at the…

    Scientists at the University of Texas at Austin report new pharmacokinetics data from the use of Thin Film Freezing technology to deliver remdesivir through dry powder inhalation

    Dry powder formulation of remdesivir with leucine found to allow more sustained release of remdesivir from lung to plasma

    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 commented on new animal pharmacokinetics data evaluating the development of remdesivir as a dry powder for inhalation by Thin Film Freezing (TFF).

    Top-line results of the study conducted by a team of researchers at the University of Texas at Austin's Division of Molecular Pharmaceutics and Drug Delivery, concluded that, "TFF technology produces high potency remdesivir dry powder formulations for inhalation suitable to treat patients with COVID-19 on an outpatient basis and earlier in the disease course where effective antiviral therapy can reduce related morbidity and mortality."

    Results of the study, led by Dr. Robert O. (Bill) Williams III, the inventor of the TFF technology, were published yesterday as a preprint in bioRxiv.

    Remdesivir (GS-5734), an investigational broad-spectrum antiviral agent, was developed by Gilead Sciences Inc. Remdesivir exhibits in vitro activity against SARS-CoV-2 and an intravenous formulation was granted Emergency Use Approval by the US FDA for treatment of hospitalized, seriously ill COVID-19 patients. Remdesivir is a prodrug that is intracellularly metabolized in the body into its active form, GS-441524.

    The UT Austin research team, in order to maximize drug delivery to the lungs, formulated remdesivir as a dry powder for inhalation using thin film freezing (TFF). TFF produces brittle matrix nanostructured aggregates that are sheared into respirable low-density microparticles upon aerosolization from a passive dry powder inhaler. The study demonstrated that in in vitro aerodynamic testing, remdesivir combined with optimal excipients, exhibited desirable aerosol performance (up to 93.0% FPF; 0.82μm MMAD). Remdesivir was amorphous after the TFF process, which benefitted drug dissolution in simulated lung fluid. TFF remdesivir formulations were shown to be stable after one-month storage at 25oC/60%RH. The study further indicated that TFF formulation of remdesivir combined with optimal excipients, like leucine, delayed the absorption into systemic circulation, allowing remdesivir to remain and be hydrolyzed to the nucleoside analog GS-441524 in the lungs. Consequently, it is believed that levels of GS-441524 can be prolonged at the target site, the lungs.

    "This significant new in vitro research continues to build and advance the seminal work done earlier by Dr. Williams and his team on reformulating remdesivir using our Thin Film Freezing technology," said Glenn Mattes, President and CEO of TFF Pharmaceuticals. "This study developed significant new data on the delivery of high drug loads of remdesivir and its active form to the lungs, as well as confirmed the important temperature stability benefits that Thin Film Freezing imparts on drug formulations, a potentially key factor in future vaccine delivery efforts."

    "Since remdesivir is a poorly water-soluble drug, its dissolution may be a critical factor in the drug's release in the lung fluid, especially in high drug load formulations. Our data indicates that dry powder administration can deliver high potency remdesivir to the lungs, which is then converted to its nucleoside analog GS-441524 at the target site before entering the system circulation," said Robert O. Williams III, study co-author. "And importantly, new data from the study regarding the formulation of remdesivir with leucine suggest that the TFF formulation can significantly prolong the duration of the remdesivir nucleoside analog GS-441524 in the lung, providing a important therapeutic benefit for lung delivery."

    "This is vital work being pursued by Dr. Williams and his team, as it potentially brings us closer to the day when this treatment could be administered to patients earlier in the disease, directly to site of initial infection and in a convenient and accessible dosage form that could be administered outside of a hospital setting" said Mattes. "It's another real-world demonstration of the ability of our Thin Film Freezing platform to adapt to a variety of compounds that may be poorly water soluble and thus may be challenging to deliver therapeutically."

    "Remdesivir is the proprietary product of Gilead and, at this time, TFF has no agreements with Gilead concerning a collaboration built around remdesivir and our TFF platform," said Mattes. "And while we intend to pursue meaningful discussions with Gilead regarding the results of Dr. Williams' growing dossier of formulation work, there can be no assurance that this effort would result in a collaboration between our companies."

    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 the dry powder version of remdesivir 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 engage Gilead, the owner of remdesivir, in discussions concerning a collaboration between the two companies or, if it does, that any such discussions will lead to a collaboration, (ii) the risk that the Company may be unable to successfully conclude clinical testing or obtain pre-market approval of its dry powder versions of Voriconazole and 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 Registration Statement on Form S- filed with the SEC on September 9, 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.

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  37. Phase 1 Dosing of Voriconazole Inhalation Powder up to 80 mg/dose in healthy subjects for direct-to-lung delivery of voriconazole for Invasive Pulmonary Aspergillosis (IPA)

    Phase 2 studies to commence, assessing the efficacy of the dry powder formulation for the treatment of IPA

    Company is investigating potential treatment or prevention of COVID-19 Associated Pulmonary Aspergillosis (CAPA) and other pulmonary fungal infections

    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 topline safety data from its Phase 1 clinical trial of Voriconazole Inhalation Powder…

    Phase 1 Dosing of Voriconazole Inhalation Powder up to 80 mg/dose in healthy subjects for direct-to-lung delivery of voriconazole for Invasive Pulmonary Aspergillosis (IPA)

    Phase 2 studies to commence, assessing the efficacy of the dry powder formulation for the treatment of IPA

    Company is investigating potential treatment or prevention of COVID-19 Associated Pulmonary Aspergillosis (CAPA) and other pulmonary fungal infections

    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 topline safety data from its Phase 1 clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of voriconazole. Voriconazole is generally considered to be the most effective antifungal drug for treating Invasive Pulmonary Aspergillosis (IPA).

    The recently completed Phase 1 trial was a randomized, double-blind, placebo-controlled study with an inhalation route of administration to 64 healthy adult volunteers that was designed with single ascending dose (SAD) and multiple ascending dose (MAD) phases. In the SAD portion, single doses of 10, 20, 40 or 80 mg were delivered to healthy normal volunteers. During the MAD portion of the trial, healthy normal volunteers received doses of 10, 20, 40 or 80 mg that were delivered twice daily for a total of 13 doses over 7 days. Thirty-two healthy subjects were enrolled in each part to evaluate the safety, tolerability and pharmacokinetic profile of Voriconazole Inhalation Powder.

    "The Voriconazole Inhalation Powder when dosed up to 80 mg twice daily showed no signs of the clinically significant hepatic or visual toxicities that were previously reported for the oral or intravenous forms of voriconazole," stated Dr. Peter Couroux, Global Senior Medical Director at Cliantha Research, who served as the Principle Investigator of the study. "We also saw no changes in pulmonary function, including FEV1, during the trial, suggesting that the drug is extremely well tolerated and is suitable to move forward in the clinical development process." 1

    An independent Data Safety Monitoring Board (DSMB) reviewed all of the clinical safety data and reported that there were, "no clinically significant adverse events, laboratory test results, electrocardiograms, or ECGs, or vital signs. Further, DSMB reported that there were no clinically meaningful relationships or trends observed for differences between vital signs, liver function tests, spirometry, visual examinations, pulse oximetry and ECGs as a function of dose or treatment."

    "The results of this trial with TFF Voriconazole Inhalation Powder at doses up to 80 mg twice daily represent a significant milestone in the development of this product since the oral or intravenous form of voriconazole, which represent the current standard of care, demonstrate significant rates of adverse events, which did not occur in our study," said Glenn Mattes, President and CEO of TFF Pharmaceuticals.

    "In addition to a better safety profile, delivery of TFF Voriconazole should produce an efficacious method of treating IPA and associated fungal infections with fewer drug-drug interaction issues when administering oral voriconazole directly to the lungs with our thin film freezing dry powder," said Mattes.

    Dosing of the Voriconazole Inhalation Powder resulted in plasma levels greater than drug levels achieved in published reports for dose levels that were efficacious in IPA patients. The Company believes this demonstrates that the TFF Voriconazole Inhalation Powder can be safely and effectively delivered to the lung, where it is needed to fight IPA infections.

    TFF Pharmaceuticals will now advance the Voriconazole Inhalation Powder into Phase 2 studies to assess the efficacy of the dry powder formulation for the treatment of IPA. 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.

    COVID-19 Associated Pulmonary Aspergillosis (CAPA)

    TFF Pharmaceuticals is also exploring the use of the product for the treatment or prevention of COVID-19 Associated Pulmonary Aspergillosis (CAPA) and other pulmonary fungal infections. These pulmonary fungal infections are increasing due to the use of corticosteroids for treatment of COVID-19. Treatment with corticosteroids predispose patients to Aspergillus infections and reports are emerging demonstrating that severe COVID-19 patients are increasingly being affected by these fungal co-infections.

    "TFF is aware of the increasing prevalence of IPA in COVID-19 patients," said Glenn Mattes. "We are working with our clinical and regulatory teams to quickly determine the best path forward to validate TFF Voriconazole's role in treatment of this serious fungal infection."

    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.

    1. FEV1: Forced Expiratory Volume in the first second. The volume of air that can be forced out in one second after taking a deep breath, an important measure of pulmonary function.

    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 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 voriconazole and 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 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.

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  38. Panel discussion scheduled for Thursday, September 17, 2020 at 11:00 AM EDT

    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 a webinar titled A Too Quiet Pandemic – Fungal Disease, presented by Maxim Group LLC and M-Vest, on Thursday, September 17th, 2020.

    Glenn Mattes, President & CEO of TFF Pharmaceuticals, and Dr. Dale Christensen, Director of Clinical Development at TFF Pharmaceuticals, will participate in a panel discussion led by Dr. Jason McCarthy, Maxim's Senior Managing Director of Biotechnology Equity Research, along with other leading…

    Panel discussion scheduled for Thursday, September 17, 2020 at 11:00 AM EDT

    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 a webinar titled A Too Quiet Pandemic – Fungal Disease, presented by Maxim Group LLC and M-Vest, on Thursday, September 17th, 2020.

    Glenn Mattes, President & CEO of TFF Pharmaceuticals, and Dr. Dale Christensen, Director of Clinical Development at TFF Pharmaceuticals, will participate in a panel discussion led by Dr. Jason McCarthy, Maxim's Senior Managing Director of Biotechnology Equity Research, along with other leading innovators in the fungal drug development space.

    To access the presentation, please RSVP here. Following the conference, a live audio webcast of the panel discussion will be available on the Events page in the Investors section of the Company's website. A recording of the panel will also be available for replay on the M-Vest platform.

    Webinar Details:

    • Panel Session Title: A Too Quiet Pandemic – Fungal Disease
    • Data and Time: Thursday, September 17, 11:00 AM EDT

    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 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 Voriconazole and 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 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.

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  39. Corporate presentation and live webcast scheduled for Monday, September 14, 2020 at 4:00 PM EDT

    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 the 22nd Annual H.C. Wainwright Global Investment Conference, taking place virtually from September 14-16, 2020.

    Glenn Mattes, President & CEO of TFF Pharmaceuticals, is scheduled to give a corporate overview on Monday, September 14, 2020 at 4:00 PM EDT, and will participate in one-on-one partnering meetings with investors and other conference attendees.

    A live webcast of the presentation will be…

    Corporate presentation and live webcast scheduled for Monday, September 14, 2020 at 4:00 PM EDT

    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 the 22nd Annual H.C. Wainwright Global Investment Conference, taking place virtually from September 14-16, 2020.

    Glenn Mattes, President & CEO of TFF Pharmaceuticals, is scheduled to give a corporate overview on Monday, September 14, 2020 at 4:00 PM EDT, and will participate in one-on-one partnering meetings with investors and other conference attendees.

    A live webcast of the presentation will be available at the following link: https://wsw.com/webcast/hcw7/tffp/1608336. Following the conference, an archived version of the webcast will be available under the Events Calendar tab in the Investors section of the Company's website.

    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.

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  40. Enters into worldwide license agreement with UNION Therapeutics for its Thin Film Freezing technology in combination with niclosamide

    Closes on $25.9 million private financing to further advance its technology platform for inhalable drug products, vaccines, biologics and botanicals

    Completes Phase 1 trial dosing for Voriconazole Inhalation Powder and begins Phase 1 trial for Tacrolimus Inhalation Powder

    Conference call and live webcast scheduled for Thursday, August 13, 2020 at 4:30pm EDT

    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 reported financial results…

    Enters into worldwide license agreement with UNION Therapeutics for its Thin Film Freezing technology in combination with niclosamide

    Closes on $25.9 million private financing to further advance its technology platform for inhalable drug products, vaccines, biologics and botanicals

    Completes Phase 1 trial dosing for Voriconazole Inhalation Powder and begins Phase 1 trial for Tacrolimus Inhalation Powder

    Conference call and live webcast scheduled for Thursday, August 13, 2020 at 4:30pm EDT

    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 reported financial results for the first quarter ended June 30, 2020, as well as provided a business update on recent corporate and clinical developments. The Company will discuss its clinical, corporate and financial highlights on a conference call and live webcast, scheduled today, Thursday, August 13, 2020 at 4:30pm EDT.

    "TFF Pharmaceutical's accomplishments during the quarter, and in recent weeks, have truly demonstrated the capability and potential of our groundbreaking technology platform," said Glenn Mattes, President and CEO of TFF Pharmaceuticals. "Most recently, our worldwide licensing agreement with UNION Therapeutics on our Thin Film Freezing technology for oral and inhalation versions of niclosamide has the potential to speed efforts to reformulate and investigate this very promising existing drug for COVID-19 therapies. It is gratifying to have our technology recognized by a company that has years of experience in working with niclosamide in a variety of therapeutic areas."

    "The recognition of the significance of our platform is further evidenced by our highly successful $25.9 million financing, completed on August 13, supported by a number of leading life science investment firms. These funds will be used to advance our clinical programs, the continued research and development of inhalable drug products, vaccines, biologics and botanicals and furthering ongoing business development and partnering initiatives."

    "Our lead clinical program, Voriconazole Inhalation Powder, the first clinical study ever in healthy subjects of a direct-to-lung, dry-powder formulation for the treatment of Invasive Pulmonary Aspergillosis (IPA) successfully completed Phase 1 dosing, with initial indications that doses of up to two times higher than those reported to be efficacious in the treatment of IPA appeared to be safe."

    "We also began our second clinical trial program with the Phase 1 dosing of healthy subjects of Tacrolimus Inhalation Powder, an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection," said Mattes. "This trial has successfully started despite a challenging clinical trial environment due to the COVID-19 pandemic."

    "And this quarter, we continue to see the broad capabilities of our platform to reformulate existing drugs into inhalation forms that may prove to be more effective," said Mattes. "The inventor of our TFF technology, Dr. Robert O. (Bill) Williams III, demonstrated recently the ability to effectively reformulate remdesivir, one of the most important new COVID-19 therapeutics, into a dry powder form that could dramatically enhance its treatment options."

    "In a time of extraordinary need, we are very proud that our scientists, clinicians and collaborators have worked so diligently to help fulfill the promise of our technology and platform," said Mattes. "This is ultimately what we envisioned when we began this Company, to be able to rapidly investigate, prototype and develop a wide variety of compounds using our technology for better efficacy and effect. We look forward to continued progress in these efforts in the quarters to come," concluded Mattes.

    Conference Call and Webcast Information

    The Company will host a conference call today, Thursday, August 13, 2020, at 4:30 pm, Eastern Daylight Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

    U.S. Dial-In Number: Toll-Free: (800) 816-3024

    International Dial-In Number (857) 770-0106

    Conference ID: 7516247

    The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals' website, https://tffpharma.com or directly at https://edge.media-server.com/mmc/p/28vdaqxx. Please access the Company's website 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 in the Events Calendar of the Investors section.

    Recent Corporate and Clinical Highlights:

    • Worldwide Licensing Agreement with UNION Therapeutics: On August 12, 2020, the Company announced a worldwide exclusive licensing agreement with UNION Therapeutics (UNION) for its Thin Film Freezing technology used in combination with niclosamide. UNION Therapeutics will acquire an option to obtain a worldwide exclusive license of TFF Pharmaceuticals Thin Film Freezing technology to be used in combination with oral and inhalation versions of niclosamide, potentially for COVID-19 as well as other therapies, and for its use in other UNION developed salts, derivatives and structurally related compounds.
    • Private Financing Round: On August 11, 2020, the Company entered into a definitive agreement with a syndicate of high quality healthcare investors for the private placement of up to $25,913,550, before deducting placement agent and other offering expenses, of common shares of the Company. The placement closed on August 13th. Net proceeds from the financing will be used to accelerate the expansion of the company's internal development portfolio beyond its programs for Voriconazole and Tacrolimus inhalation powders.
    • Voriconazole Inhalation Powder: TFF's lead clinical program, Voriconazole Inhalation Powder, to treat the severe and life-threatening disease of Invasive Pulmonary Aspergillosis, or IPA, successfully completed the clinical portion of its Phase 1 trial with both Single Ascending Dose and Multiple Ascending Dose phases with 32 healthy subjects enrolled in each to evaluate the safety, tolerability and pharmacokinetic profile of Voriconazole Inhalation Powder. Initial topline results indicate that repeated doses of up to 80 mg/dose twice daily for 7-days in healthy normal volunteers were well tolerated.
    • Tacrolimus Inhalation Powder: TFF's second clinical program, Tacrolimus Inhalation Powder, began Phase I trials. This single ascending dose (SAD) and multiple ascending dose (MAD) study will assess the safety, tolerability and pharmacokinetic profile of the Tacrolimus Inhalation Powder in healthy subjects. Tacrolimus is an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection. Subjects were successfully enrolled and dosed at a single site in Australia under the Australian CTN process, despite the clinical trial challenges posed by the COVID-19 pandemic.



      In June, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to Tacrolimus Inhalation Powder for prophylaxis of lung allograft rejection.
    • COVID-19/SARS-CoV-2 Drug Repurposing Feasibility Projects: TFF is actively reviewing previously FDA approved drugs that may be repurposed to combat the novel coronavirus behind the COVID-19 pandemic outbreak. The Company is reviewing libraries of compounds that could potentially benefit from the characteristics of the TFF technology in developing a dry powder product delivered directly to the lung that is capable of targeting SARS-CoV-2 and potentially similar viruses such as SARS-CoV, MERS-CoV and other endemic coronaviruses.



      During the quarter, the Company and the inventor of its TFF technology, Dr. Robert O. (Bill) Williams III, continued to evaluate the existing antiviral drug, niclosamide, to enhance its effect as a potential COVID-19 therapy. Niclosamide is an FDA-approved oral anthelminthic drug that we believe has the potential to be repurposed to treat a variety of viral infections, such as severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV), Zika virus (ZIKV), and others. Our Thin Film Freezing technology will be evaluated by UNION therapeutics to develop an inhaled form of niclosamide that could potentially enhance this promising drug's bioavailability for treating respiratory modes of infection. If successful, UNION therapeutics or TFF Pharmaceuticals, depending on whether Union exercises its option, would potentially progress to filing an IND for this compound with the FDA.



      Also, after the end of the quarter, Dr. Williams presented initial results of research evaluating the re-formulation of remdesivir to a dry powder form for COVID-19 antiviral treatment for inhalation using the Company's Thin Film Freezing technology. Dr. Williams' research team at the University of Texas at Austin's Division of Molecular Pharmaceutics and Drug Delivery developed inhaled forms of remdesivir for protecting and treating the respiratory mode of infection, including an amorphous brittle matrix powder made by Thin Film Freezing.

    Financial Results

    For the six months ended June 30, 2020, compared to the prior year

    • Research and Development (R&D) expenses: R&D expenses for the six months ended June 30, 2020 were $4.80 million, compared to $2.99 million for the same period in 2019.
    • General & Administrative (G&A) expenses: G&A expenses for the six months ended June 30, 2020 were $2.89 million, compared to $1.42 million for the same period of 2019.
    • Net Loss: TFF Pharmaceuticals reported a net loss for the six months ended June 30, 2020 of $7.61 million, compared to a net loss of $4.37 million for the same period of 2019.
    • Shares Outstanding: Weighted average common shares outstanding, basic and diluted, for the six months ended June 30, 2020 were 19,040,134, compared with 4,400,000 for the same period in 2019.

    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 Tacrolimus, the potential license of our technology to UNION therapeutics 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 UNION will not exercise its option and that the collaboration will go no further than the investigator lead studies, (ii) if UNION does exercise its option to license TFF's technologies, the risk that UNION will not pursue the development of a product candidate under the license with TFF or, if it does, that such product candidate will obtain regulatory approval or commercial success, (iii) the risk that few, or none, of the conditions for the milestone or sales-based payment will be satisfied and TFF will receive little, or none, of such milestone and sales-based payments, (iv) 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, (v) the Company 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 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.

    TFF PHARMACEUTICALS, INC.

     

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

     

     

     

    Three Months

    Ended

    June 30,

    2020

     

    Three Months

    Ended

    June 30,

    2019

     

    Six Months

    Ended

    June 30,

    2020

     

    Six Months

    Ended

    June 30,

    2019

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    2,567,771

     

     

    $

    1,319,656

     

     

    $

    4,803,313

     

     

    $

    2,990,518

     

    General and administrative

     

     

    1,274,803

     

     

     

    889,453

     

     

     

    2,892,727

     

     

     

    1,421,051

     

    Total operating expenses

     

     

    3,842,574

     

     

     

    2,209,109

     

     

     

    7,696,040

     

     

     

    4,411,569