Announced Collaboration with Catalent to Further Expand Thin Film Freezing Applications with a Focus on Biologic Drug Development
Announced Second CRADA Agreement with
Initiated Phase 2 Trials of Inhaled Voriconazole Powder and Inhaled Tacrolimus Powder With Interim Data for Each Program Expected Later in 2022
Significant Progress Made in Inhaled Niclosamide Powder Program
Multiple Abstracts Highlighting Applications of Thin Film Freezing Presented at Respiratory Drug Delivery (RDD) Meeting
Conference Call and Webcast Scheduled Today, Wednesday, May 11, 2022 at
“During the first quarter, we made solid progress in expanding existing collaborations and forging new partnerships,” said
“With respect to our pipeline development, we made considerable progress across several programs during the quarter. We initiated Phase 2 studies for our Inhaled Voriconazole Powder and Inhaled Tacrolimus Powder, and we anticipate interim readouts for both trials later in the year. With each program having the potential to meaningfully advance the current standard of care in their respective indications, we believe positive readouts are likely to attract significant partnership interest.
The Inhaled Niclosamide Powder program has also made important progress. In April, we announced positive safety and pharmacokinetic data from a Phase 1 study, demonstrating that Niclosamide Inhalation Powder was well tolerated with no serious adverse events across all subject cohorts. We believe the Niclosamide program is yet another example of how Thin Film Freezing technology can be successfully applied in the clinic to deliver efficacious levels of drug more safely to patients.
“In early May, we were pleased to announce that Dr.
“As our platform continues to expand, TFF is also making the appropriate level of investment to recruit exceptional talent to help manage this growth. During the quarter, we announced the appointment of
“The advancement of our internal pipeline candidates such as Inhaled Voriconazole and Tacrolimus Powder programs, coupled with the robust pace of ongoing partnering activity, strengthens our belief that our continued investment in Thin Film Freezing will translate into significant commercial success and value for our shareholders.”
Conference Call and Webcast Information
The Company will host a conference call today,
Domestic Dial-In Number: Toll-Free: 1-844-825-9789
International Dial-In Number: 1-412-317-5180
Conference ID: 10166801
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://viavid.webcasts.com/starthere.jsp?ei=1546904&tp_key=ca1cf4dc0b
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:
- Board of Director Appointment: In March, the Company announced the appointment of
Brandi Robertsto the TFF Pharmaceuticals’ Board of Directors. Ms. Robertshas over 25 years of public accounting and finance experience, including 22 years at publicly traded pharmaceutical, medical technology, and life science companies. Ms. Robertshas served as the Chief Financial Officer of Longboard Pharmaceuticals, Inc. since January 2021. Previously, Ms. Robertsserved as Chief Financial Officer of Lineage Cell Therapeutics, Inc. from January 2019to January 2021. Prior to joining Lineage, she served as Chief Financial Officer of REVA Medical, Inc. Ms. Robertspreviously served as Chief Financial Officer of Mast Therapeutics, Inc. from January 2013to April 2017, and as its Senior Vice President, Finance, from March 2011to January 2013. Previously, she held senior positions at Alphatec Spine, Inc., Artes Medical, Inc., Stratagene Corporation, and Pfizer, Inc. Ms. Robertscurrently serves as Chair of the Southern California Chapter of the Associationof Bioscience Financial Officers and has served on the Board of Temple Therapeutics BVsince November 2019. Ms. Robertsis a certified public accountant with the State of Californiaand received her B.S. degree in business administration from the University of Arizonaand her M.B.A. from the University of San Diego.
- Appointment of Chief Scientific Officer: In March, the Company announced the appointment of
Anthony Hickey, Ph.D. as Chief Scientific Officer. Dr. Hickeyis Professor Emeritus in Pharmacoengineering and Molecular Pharmaceutics at the Eshelman School of Pharmacyof the University of North Carolina at Chapel Hill. Dr. Hickeyis also Adjunct 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 additional seasoned executives to help lead the company:
- John Koleng, Ph.D., R.Ph. – Vice President of Product Development and Manufacturing
Dr. Kolenghas more than 20 years of experience in the pharmaceutical industry. He was an executive with three drug development companies, Oticara, Via Therapeutics, and CloXero Therapeutics, and co-founded AlphaVektor, LLCand Axxis Innovations, Inc.John is an industry-recognized expert in drug development including nasal/pulmonary products and injectables. John previously served as a consultant to TFF and is an inventor on several patent applications filed on behalf of TFF. He has a B.S. in Pharmacy and a Ph.D. in Pharmaceutics, both from the University of Texas at Austinwhere he currently is an Adjunct Assistant Professor of Pharmaceutics and serves on the College of Pharmacy Dean’s Advisory Council. He is a registered pharmacist. Greg J. Davenport, Ph.D. – Vice President of Government and Strategic Initiatives Dr. Davenportbrings over 28 years of pharmaceutical product development and government contracting experience as a C-Level Executive in the life sciences. Greg is a founding partner of Dport Federal Group, LLC, a consulting firm that assists various clients in the life science and pharmaceutical industries seeking to conduct business with the Federal Government. At TFF, Dr. Davenportoversees academic, government, and industry infectious disease and biodefense collaborations, while also pursuing non-dilutive funding to advance TFF’s technology platform and products to address government and commercial needs. Greg earned a B.S. from Dillard Universityand received his Ph.D. in Molecular Biology from Howard University. Paul Manley– Head of Regulatory Affairs
Mr. Manley has accumulated 30+ years of business and senior management experience in regulatory affairs, compliance and overall drug development across a range of therapeutic areas. Paul’s corporate career encompasses senior management and technical leadership positions within the
U.S.and Europein both large corporations (VP, Global Regulatory Affairs – Oncology, Johnson & Johnson) and start-ups (VP, Regulatory Affairs and Compliance, Genta Incorporated). In 2007, Paul established Orvieto Consulting, LLC, providing strategic advice to numerous companies across a wide range of scientific disciplines.
- John Koleng, Ph.D., R.Ph. – Vice President of Product Development and Manufacturing
- Strategic Business Development and Partnership Activities – Biopharmaceutical Companies and Research Institutions:
- In May, the Company announced multiple presentations highlighting the broad applicability of its Thin Film Freezing Technology at the Respiratory Drug Delivery Meeting (RDD)
- In April, the Company announced safety and pharmacokinetic data from its Phase 1 study of Niclosamide Inhalation Powder, which is being developed as a potential treatment for COVID-19. The data showed that Niclosamide Inhalation Powder was well tolerated with no serious adverse events across all subject cohorts.
- In March, TFF entered into a collaboration agreement with Catalent focused on providing access to the innovative TFF technology to Catalent’s large number of clients, which has the potential to increase the adoption of the pulmonary and nasal route for the systemic delivery of biotherapeutics. In addition, Catalent will become the CDMO of choice for these referred clients and Catalent will assume a priority position in collaborations using TFF’s proprietary process for biologic drug manufacturing.
- In February, announced that results from its recently completed in vitro neutralization and viral replication assays indicate that the Niclosamide Inhalation Powder completely inhibited viral replication of both the Delta and Omicron variants of SARS-CoV-2. Compared to data from previously published studies, the results demonstrate that Niclosamide Inhalation Powder appears to be the most potent inhibitor of SARS-CoV-2 replication, including the Omicron variant. Results from these studies also confirm previous findings which validated the potent antiviral efficacy of Niclosamide in a human airway model.
In January, announced the completion of enrollment of 40 healthy subjects for a Phase 1 clinical trial (NCT#05168644) of Niclosamide Inhalation Powder. The Company is developing Niclosamide Inhalation Powder in partnership with Union Therapeutics as a potential antiviral treatment to treat COVID-19 and other respiratory viral diseases.
- Strategic Business Development and Partnership Activities – Governmental and Defense Contracting Agencies:
- In March, entered into a new
Cooperative Researchand Development Agreement with the United States Army Medical Research Institute of Infectious Diseases, also known as USAMRIID, and the Geneva Foundation, a nonprofit foundation that supports and advances innovative medical research within the U.S.Military. TFF Pharmaceuticalsand USAMRIID will evaluate the immune response of a dry powder recombinant Vesicular Stomatitis Virus – Severe Acute Respiratory Syndrome Coronavirus-2 Glycoprotein vaccine formulated using TFF’s Thin Film Freezing technology. The end goal is to develop a single, easily administered and temperature stable countermeasure to protect our warfighters against multiple viral pathogens such as SARS-CoV-2, Ebola, and Marburg.
- In March, entered into a new
For the quarter ended
- Cash Position: As of
March 31, 2022, TFF Pharmaceuticalsreported cash and cash equivalents of $26.4 million.
- Research and Development (R&D) expenses: R&D expenses for first quarter of 2022 were
$5.3 million, compared to $5.3 millionin 2021.
- General & Administrative (G&A) expenses: G&A expenses for the first quarter of 2022 were
$3.2 million, compared to $2.6 millionin 2021.
- Net Loss:
TFF Pharmaceuticalsreported a net loss for the first quarter of 2022 of $8.4 million, compared to a net loss of $7.7 millionin 2021.
ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING TECHNOLOGY PLATFORM
TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.
ABOUT TFF PHARMACEUTICALS
This press release contains forward-looking statements regarding
Investor Relations Contact:
1 Denning DW, Pleuvry A, Cole DC. Global burden of allergic bronchopulmonary aspergillosis with asthma and its complication chronic pulmonary aspergillosis in adults. Med Mycol. 2013 May;51(4):361-70. doi: 10.3109/13693786.2012.738312. Epub 2012
|UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Three Months Ended|
|Research and development||5,261,604||5,278,252|
|General and administrative||3,246,195||2,647,415|
|Total operating expenses||8,507,799||7,925,667|
|Loss from operations||(8,440,364||)||(7,901,352||)|
|Total other income||64,362||246,777|
|Net loss per share, basic and diluted||$||(0.33||)||$||(0.33||)|
|Weighted average common shares outstanding, basic and diluted||25,371,781||23,140,607|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||26,414,170||$||33,794,672|
|Receivable due from collaboration agreement||1,776,583||1,628,703|
|Research and development tax incentive receivable||1,168,830||966,646|
|Prepaid assets and other current assets||2,164,451||2,447,930|
|Total current assets||31,524,034||38,837,951|
|Property and equipment, net||2,258,738||1,859,860|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Deferred research grant revenue||168,000||50,000|
|Commitments and contingencies|
|Additional paid-in capital||105,256,670||104,078,968|
|Accumulated other comprehensive loss||(1,687||)||(48,921||)|
|Total stockholders’ equity||31,585,993||38,737,059|
|Total liabilities and stockholders’ equity||$||33,782,772||$||40,697,811|
Source: TFF Pharmaceuticals, Inc.