Announces partnership with Catalent to further expand the application of thin film ice cream to the development of biological medicine
USAMRIID and the Geneva Foundation have announced a second CRADA agreement to develop new thin-film freezing therapies for SARS-CoV-2, Ebola and Marburg.
Phase 2 trials of Voriconazole inhalation powder and tacrolimus inhalation have begun, with provisional data for each program expected in 2022.
Significant progress in the niclosamide powder breathing program
Numerous abstracts highlight the use of frozen films at the Respiratory Drug Delivery (RDD) conference
Conference call and webcast today, Wednesday, May 11, 2022, at 4:30 p.m., ET.
FORT WORTH, TX, May 11, 2022 (GLOBE NEWSWIRE) – TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical phase biopharmaceutical company, develops and markets innovative thin film-based freezing (TFF). Today, the technology platform announced the financial results for the first quarter of 2022 and provided an update on the latest corporate and clinical developments. The company will discuss the highlights of the conference call and webcast scheduled for today, Wednesday, May 11, 2022, at 4:30 p.m.
“In the first quarter, we made great strides in expanding existing partnerships and establishing new partnerships,” said Glenn Matthes, CEO of TFF Pharmaceuticals. “Most importantly, we announced a strategic partnership with Catalent that will allow our customers to access our thin film ice cream technology with a focus on organic applications. We also expanded our commitment to USAMRIID and the Geneva Foundation by signing a second CRADA agreement to leverage our thin film ice cream technology. to help develop new therapies to fight very dangerous viruses, including SARS-CoV-2 optimization Ebola and Marburg Based on the active pace of our current collaborative discussions, we are confident that TFF Pharmaceuticals will expand our existing partnerships and introduce new ones in 2022 .
The story goes on
“During the quarter, we have made significant progress in a number of pipeline development programs. We have started Phase 2 studies with voriconazole inhalation powder and tacrolimus inhalation powder and we expect the provisional results of two studies by the end of the year. We believe that positive signals will be of great benefit to the partnership, as each program has the potential to significantly improve the current standard of care in terms of performance.
The Niclosamide Powder Breathing Program has also made great strides. In April, we published positive safety and pharmacokinetic data from a Phase 1 study that inhaled niclosamide powder was well tolerated in all study cohorts, with no significant adverse events. We believe that the Niklosamide program is another example of the successful application of thin film ice cream technology to patients in a more effective way to deliver drugs to patients.
“In early May, we met a doctor who was the inventor of thin-layer ice cream technology. We are pleased to report that Bill Williams and several colleagues at the University of Texas at Austin have presented five abstracts at this year’s Respiratory Medicine meeting. Thin film applications for ice cream. We believe that this set of research highlights the unique and versatile nature of thin film ice cream technology and that this technology gives us great confidence that our pharmaceutical applications will only grow over time.
“As our platform continues to grow, TFF is investing heavily in hiring extraordinary talent to support this growth. During the quarter, we announced the appointment of Anthony Hickey, Ph.D. and Brandi Roberts to the Board of Directors. We have also appointed them. positions in key areas of our business, including product development, government and policy initiatives, and regulatory work.
“The evolution of our internal candidates, such as the inhaled voriconazole inhaler and tacrolimus powder programs, along with the rapid pace of ongoing collaboration, will continue to be a significant commercial success in our Thin Film Freeze and will strengthen our shareholder value.”
Information on conferences and webcasts
The company will hold a conference call today, Wednesday, May 11, 2022, at 4:30 p.m. ET to discuss clinical, corporate, and financial issues. To join a conference call, dial the following numbers before the call begins:
Extension Number: Toll Free: 1-844-825-9789
International telephone number: 1-412-317-5180
Conference number: 10166801
The call will be made live on the web and will be available on TFF Pharmaceuticals at https://tffpharma.com or directly at https://viavid.webcasts.com/starthere.jsp?ei=1546904&tp_key=ca1cf4dc0b.
Visit the company’s website to register, download, and install the required audio software at least 15 minutes before the conference. The conference call can be re-issued throughout the month in the “Calendar of Investor Events” section of the Company’s website.
Current clinical and corporate roles:
Board Appointments: In March, the company announced the appointment of Brandi Roberts to the board of directors of TFF Pharmaceuticals. Ms. Roberts has more than 25 years of experience in public accounting and finance, including 22 years in public pharmaceutical, healthcare and medical technology companies. Ms. Roberts has served as Chief Financial Officer of Longboard Pharmaceuticals, Inc. since January 2021. Ms. Roberts served as Chief Financial Officer of Lineage Cell Therapeutics, Inc. from January 2019 to January 2021. Prior to joining Lineage, he was a leader. The Chief Financial Officer of REVA Medical, Inc. was previously the Chief Financial Officer of Mast Therapeutics, Inc. from January 2013 to April 2017 and the Vice President of Finance from March 2011 to January 2013. He previously held leadership positions at Alphatec Spine Inc., Arts Medical, Inc., Stratagene Corporation and Pfizer Inc. Council of Temple Therapeutics BV November 2019. Ms. Roberts is an Accountant in California with a degree in Business Administration from the University of Arizona. and an MBA from the University of San Diego.
Appointment of Scientific Director: In March, the company announced the appointment of Dr. Anthony Hickey as Principal Investigator. Dr. Hickey is Professor Emeritus of Pharmaceutical Engineering and Molecular Pharmacy at the Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill. Dr. Hickey is also an Assistant Professor of Biomedical Engineering at the University of North Carolina (UNC) School of Medicine.
Expanded Leadership Team: In March, the company also announced the appointment of three more senior executives to lead the company:
John Coleng, Ph.D., R.Ph. – PhD Vice President of Product Development and Manufacturing. Koleng has more than 20 years of experience in the pharmaceutical industry. He has held leadership positions in three drug development companies: Oticara, Via Therapeutics and CloXero Therapeutics and is one of the founders of AlphaVector, LLC and Axxis Innovations, Inc. John is a renowned expert in the pharmaceutical industry, including nasal and pulmonary drugs. and injectable. John previously worked as a consultant for TFF and is the inventor of several patent applications on behalf of TFF. Bachelor of Pharmacy and PhD. He is currently an Assistant Professor of Pharmacy and Pharmacy at the University of Texas at Austin and a member of the Advisory Board of the Dean of the University of Pharmacy. He is a state pharmacist.
Greg J. Davenport, Ph.D. – Vice-President of Management and Strategic Initiatives. Davenport brings more than 28 years of experience in pharmaceutical product development and government procurement as a C-level performer in the life sciences. Greg Dport is a founding partner of Federal Group, LLC, a consulting firm that serves the life sciences and pharmaceutical clients who want to do business with the federal government. TFF doctor. Davenport oversees university-government industry partnerships in infectious diseases and biosafety, and provides nonprofit funding for the development of technology platforms and TFF products to meet government and commercial needs. Greg Dillard is a graduate of the University and holds a PhD. In Molecular Biology at Howard University.
Paul Manley – Compliance Manager. Mr. Manley has more than 30 years of business and leadership experience in regulatory, compliance, and overall drug development in a variety of therapeutic areas. Paul’s corporate career has led to technical leadership and senior positions in major U.S. corporations (VP of Global Regulatory Affairs – Oncology, Johnson & Johnson) and start-ups (VP of Regulatory Affairs and Compliance, Genta Incorporated). and Europe. In 2007, Paul founded Orvieto Consulting LLC, which provides strategic advice to many businesses in a variety of areas.
Strategic business development and partnerships – biopharmaceutical companies and research institutes:
In May, the company announced several presentations at the Respiratory Drug Delivery (RDD) meeting, highlighting the widespread use of thin-film ice cream technology.
In April, the company released safety and pharmacokinetic data from a phase 1 study of niclosamide inhalation powder, which was being developed as a potential treatment for COVID-19. The data showed that niclosamide inhalation dust was well tolerated by all subject cohorts without significant adverse events.
In March, TFF signed a partnership with Catalent to provide access to innovative TFF technology that could increase lung and nasal permeability in the administration of biotherapists for many Catalent clients. In addition, Catalent will be selected by CDMO for these target customers and Catalent will prioritize collaboration using the proprietary TFF process for organic production.
In February, the results of recent in vitro virus neutralization and replication studies showed that inhalation niclosamide powder completely inhibited the viral replication of the SARS-CoV-2 delta and omicron variants. Compared to previously published studies, the results show that niclosamide is the most potent inhibitor of SARS-CoV-2 replication, including a variant of Omicron powder inhalation. The results of these studies also confirm previous findings that support the potent antiviral efficacy of niclosamide in a human respiratory model.
In January, Niclosamide announced that it had completed enrollment of 40 healthy subjects in a Phase 1 clinical trial of inhaled powder (NCT # 05168644). The company is partnering with Union Therapeutics to develop niclosamide inhalation powder as a potential treatment for COVID-19 and other viral respiratory diseases.
Strategic Business Development and Cooperation Activities – Government and Defense Clients:
In March, the U.S. Army Institute for Infectious Disease Research signed a new research and development partnership agreement with the Geneva Foundation, a nonprofit foundation also known as USAMRIID, which supports and develops innovative U.S. military medical research. TFF Pharmaceuticals and USAMRIID will study the immune response to the dry powder of glycoprotein virus in vesicular stomatitis using thin TFF film freezing technology against severe acute coronary respiratory syndrome. The ultimate goal is to develop a single, easily controllable, and temperature-tolerant countermeasure to protect our warriors from multiple viral pathogens such as SARS-CoV-2, Ebola, and Marburg.
The quarter ended March 31, 2022 compared to the quarter ended March 31, 2021
Cash: As of March 31, 2022, TFF Pharmaceuticals had $ 26.4 million in cash and cash equivalents.
Research and development (R&D) expenditure: Research and development expenditure was $ 5.3 million in the first quarter of 2022, compared to $ 5.3 million in 2021.
General and administrative expenses (GA): General and administrative expenses were $ 3.2 million in the first quarter of 2022, compared to $ 2.6 million in 2021.
Net Loss: TFF Pharmaceuticals reported a net loss of $ 8.4 million in the first quarter of 2022 compared to a net loss of $ 7.7 million in 2021.
PHARMACEUTICALS TFF THIN CREAM TECHNOLOGY PLATFORM The Pharmaceuticals’s Thin Film Ice Cream (TFF) platform was developed to improve the solubility and absorption of water-insoluble drugs. deep lung, an area of major interest in respiratory medicine. The TFF process creates a “brittle matrix particle” with a low mass density, large surface area, and generally an amorphous morphology that allows the particles to settle when they touch an area such as lung tissue. According to laboratory experiments, the aerodynamic properties of the particles can be as much as 75% of the drug reaching the deep lungs.
About TFF PHARMACEUTICAL STFF Pharmaceuticals, Inc. is a clinical phase biopharmaceutical company based on the patented Thin Film Ice Cream or TFF technology platform for the development and commercialization of innovative pharmaceutical products. Preliminary research confirms that the TFF platform can significantly improve the solubility and absorption of water-insoluble drugs, which is approximately one-third of the world’s major drugs, by improving their pharmacokinetics. TFF Pharmaceuticals has two main drug candidates: voriconazole inhalation powder and tacrolimus inhalation powder. The company plans to expand the pipeline in partnership with major pharmaceutical partners. The TFF platform is protected by more than 120 U.S. and foreign patents, whether issued or pending. For more information on TFF Pharmaceuticals and its product candidates, visit the company’s website at https://tffpharma.com.
PORT SAFE In this press release, TFF Pharmaceuticals, Inc. provides forward-looking statements including expectations for the sustainability of tacrolimus and voriconazole inhalable powders and inhaled niclosamide inhalable powders for the treatment of COVID-19 infections, collaboration and reference agreements with Catalent, including benefits. the company’s TFF platform, and the company’s existing product line plans. Add. These forward-looking statements include known and unknown risks, uncertainties, and other factors that may significantly differentiate actual results. These factors include: (i) the risk of the company successfully conducting clinical trials or receiving prior approval for any inhalable tacrolimus, voriconazole or niclosamide powder or any of its potential dry powders; the risk that the protection agreements will not have the expected positive results; (iii) the TFF-based drug has not received FDA pre-market approval or otherwise entered into a commercial drug, (iv) has no active contract or development agreement with major pharmaceutical companies, (v) the risk to companies. it will not be possible to enter into long-term trade agreements with third parties. and (vi) other risks described in the “Risk Factors” section of the Company’s 2021 Annual Report submitted to the SEC on March 24, 2022. TFF Pharmaceuticals is selling the product for free. TFF Pharmaceuticals не берет на себя и, в частности, отказывается от своих обязательств по обновлению или изменению таких заявлений для отражения новых обстоятельств или непредвиденных обстоятельств, за исключением случаев, предусмотренных законом.
Гленн МэттсПрезидент and TFF Pharmaceuticals, Inc. managing director email@example.com
Кирк Коулман Финансовый Director TFF Pharmaceuticals, Inc. firstname.lastname@example.org
Kori Devis, Doctor of Philosophy. Contact LifeSci email@example.com
LifeSci Communications (269) firstname.lastname@example.org
1 Деннинг Д.В., Плеври А., Коул Д.С. Global Brane Allezichesque bronzer асергилеза стой и и оострени pie С Микол. May 2013, 51 (4): 361-70. Number: 10.3109 / 13693786.2012.738312. Epub 2012 4 decabes. PMID: 23210682. As of November 5, 2021.
TFF PHARMACEUTICALS, INC.
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