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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): March 24, 2022

 

 

 

TFF PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-39102   82-4344737
(State or Other Jurisdiction
of Incorporation)
  (Commission File Number)   (I.R.S. Employer
Identification Number)

 

1751 River Run, Suite 400

Fort Worth, Texas 76107

(Address of principal executive offices)

 

(817) 438-6168
(Registrant’s telephone number, including area code)

 

3801 S. Capital of Texas Hwy, Suite 330

Austin, Texas 79704

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions.

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14d-2(b)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

Securities registered pursuant to Section 12(b)of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which
registered

Common stock: Par value $.001   TFFP   Nasdaq Global Market

 

 

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On March 24, 2022, TFF Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal year ended December 31, 2021. A copy of the press release is attached as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

 

Item 7.01 Regulation FD Disclosure.

 

On March 24, 2022, the Company published an investor presentation on its website at https://ir.tffpharma.com/. A copy of the investor presentation is attached as Exhibit 99.2 hereto.

 

The information in this Current Report on Form 8-K, including the exhibits attached hereto, are furnished pursuant to Items 2.02 and 7.01 and shall not be deemed “filed” for any purpose, including for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Current Report on Form 8-K, including the exhibits attached hereto, shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act regardless of any general incorporation language in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

The following exhibits are furnished with this report:

 

Exhibit 99.1

Press release dated March 24, 2022 regarding the Registrant’s financial results for its fiscal year ended December 31, 2021.

Filed Electronically herewith
Exhibit 99.2 The Company’s investor presentation materials Filed Electronically herewith
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)  

 

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  TFF PHARMACEUTICALS, INC.
   
Dated: March 24, 2022/s/ Kirk Coleman
  Kirk Coleman,
  Chief Financial Officer

 

 

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Exhibit 99.1

 

 

TFF Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

 

Pipeline Advancement Continues with Ongoing Phase 2 Studies for Voriconazole and Tacrolimus Programs

 

Partnership Activity Surrounding Thin Film Freezing Continues to Expand Reflecting the Technology’s Broad Applicability Across Molecule Type and Therapeutic Area

 

Appoints Life Sciences Executive, Brandi Roberts, to Board of Directors and Anthony Hickey, Ph.D. as Chief Scientific Officer

 

Expands Leadership Team With Senior Appointments in Product Development and Manufacturing, Government and Strategic Initiatives, and Regulatory Affairs

 

Conference Call and Webcast Scheduled Today, Thursday, March 24, 2022, at 4:30 PM ET

 

 

FORT WORTH, TX -- March 24, 2022 --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 year-end December 31, 2021, and provided an update on recent corporate and clinical developments. The Company will discuss the highlights on a conference call and webcast, scheduled for today, Thursday, March 24, 2022, at 4:30 PM ET.

 

“The progress we have made in advancing our internal pipeline while expanding our partnered programs has positioned us for continued success in 2022,” said Glenn Mattes, CEO of TFF Pharmaceuticals. “Our two most advanced programs, Inhaled Tacrolimus and Voriconazole Powders, now have initiated Phase 2 studies based upon an impressive body of supportive clinical data. We expect an interim analysis in the second half of the year and will look to partner these assets after the release of these data. We believe the success of either program would not only advance the current standard of care in their respective indication but would also serve to unlock significant shareholder value for our investors.”

 

“We are also excited about the robust activity surrounding our partnered programs, which reflects a growing recognition of the potential of Thin Film Freezing technology to improve drug formulation and delivery. For example, we have partnered with Union Therapeutics to develop Inhaled Niclosamide Powder for the treatment of COVID-19 infection, and in February, TFF published new research indicating that inhaled niclosamide completely inhibited Omicron at a dose of only 1μM. In our view, this level of potency may allow us to deliver reduced doses of niclosamide directly to the lung without compromising its antiviral activity, which could lead to significant safety and tolerability advantages versus other therapies.”

 

 

 

 

“Our government and academic partnerships also continue to grow. This month, we announced a CRADA agreement with USAMRIID that will assess the immune response of a dry powder recombinant Vesicular Stomatitis Virus Severe Acute Respiratory Syndrome Coronavirus-2 Glycoprotein (TFFD-rVSV-SARS2-GP) vaccine formulated using TFF’s Thin Film Freezing technology. This is now our second CRARA agreement with USAMRIID and reflects our strategic focus to work with organizations who can provide world-class scientific talent and testing capabilities to help further validate our Thin Film Freezing technology platform.”

 

“It is also becoming increasingly clear that Thin Film Freezing’s ability to improve formulations across a broad range of molecular entities will likely lead to more strategic-based collaborations. On March 1st, Catalent and TFF Pharmaceuticals jointly announced a collaboration that will significantly expand our access to manufacturing capabilities and provide scalability for our Thin Film Freezing technology, while also affording us the opportunity to build a portfolio of technology licensing partnerships. We are very excited about this strategic collaboration with Catalent and believe it will provide us the opportunity to significantly expand the applications of our technology platform.”

 

“Today, I am also very pleased to announce the appointment of Brandi Roberts to our Board. With over two decades of financial management expertise within the life sciences sector, Brandi brings considerable talent and experience to our company and is joining us at an important time in our Company’s growth. We will clearly benefit from her insight and depth of knowledge, and I look forward to working with her.”

 

“I would also like to express my thanks to Dr. Brian Windsor, who is stepping down from his roles as Board member and CSO. Since our company’s founding, Brian has been instrumental in helping to bring Thin Film Freezing technology to so many of our partners and pipeline assets. Brian has clearly played a key role in the evolution of TFF Pharmaceuticals, and on behalf of the entire team at TFF Pharmaceuticals, we thank him for his many accomplishments and guidance, and we wish him the best in his future endeavors.”

 

“Today as well, we are very pleased to announce the appointment of Dr. Anthony Hickey as our new Chief Scientific Officer. Tony is an internationally recognized scientist who has published extensively in several areas related to our core technology, including pharmaceutical inhalation aerosols, pharmaceutical process engineering, particulate science, pharmaco-complexity and tuberculosis therapy.”

 

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“I am thrilled to assume the role of Chief Scientific Officer with TFF Pharmaceuticals”, said Dr. Anthony Hickey. “As a member of the TFF’s Scientific Advisory Board, I have seen the tremendous progress Glenn and his team have made in bringing thin film freezing technology into the mainstream of advanced formulation development. As CSO, finding opportunities to bring this innovative technology to both industry and academia will be a key focus for me, and I look forward to working with the outstanding scientists at TFF to achieve this objective.” 

 

Mr. Mattes continued, “In 2021, we demonstrated the successful application of our Thin Film Freezing technology through the generation of positive clinical data in our two lead candidates. We believe these data sets, along with expansion of testing activities for our numerous partners, all point to Thin Film Freezing’s potential as a viable, mainstream formulation technology with potential to fundamentally change drug delivery. In 2022, we plan to leverage the success from the prior year to further build momentum and growth across our business to help drive shareholder value.”

 

Conference Call and Webcast Information

 

The Company will host a conference call today, Thursday, March 24, 2022, 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: 1-877-407-3982

International Dial-In Number: 1-201-493-6780

Conference ID: 13726816

 

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://themediaframe.com/mediaframe/webcast.html?webcastid=8HlFQvDt

 

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): In November, announced the completion of dosing in the Phase 1b clinical trial of Voriconazole Inhalation Powder (TFF VORI), a next-generation, direct-to-lung, inhaled dry powder version of voriconazole for the treatment and prevention of Invasive Pulmonary Aspergillosis (IPA) (NCT #04576325). This study assessed the safety and tolerability in two cohorts of eight patients with mild to moderate asthma, a population at high risk of developing IPA. Initial data from the study suggests that TFF VORI is well tolerated in asthma patients, supporting the Company’s progress to Phase 2 study in IPA patients.

 

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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 oral 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.

 

To date, observational data from this trial support the inclusion of patients that have hyperreactive airway disease comorbidities in the Phase 2 trial. This suggests TFF VORI also may have the potential to treat Allergic Bronchopulmonary Aspergillosis (ABPA), which impacts up to 2.5%1 of asthma patients.

 

 

Science Day Event: In December, TFF Pharmaceuticals hosted a virtual Science Day which featured a presentation by Carsten Schwarz, M.D., Director of the Cystic Fibrosis Center in Potsdam Germany, on the Company’s Inhaled Voriconazole Powder for the treatment of invasive pulmonary aspergillosis (IPA), and a presentation by Christopher Emig, Ph.D., President and CEO of Augmenta Bioworks, Inc., on inhaled AUG-3387 for COVID-19. A replay of this event can be found on the TFF Pharmaceuticals website under the Investors – Events Calendar.

 

 

Board of Director Appointment: Today, the Company announced the appointment of Brandi Roberts to the TFF Pharmaceuticals’ Board of Directors. Ms. Roberts has over 25 years of public accounting and finance experience, including 22 years at publicly traded pharmaceutical, medical technology, and life science companies. Ms. Roberts has served as the Chief Financial Officer of Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH) since January 2021. Previously, Ms. Roberts served as Chief Financial Officer of Lineage Cell Therapeutics, Inc. (NYSE: LCTX) from January 2019 to January 2021. Prior to joining Lineage, she served as Chief Financial Officer of REVA Medical, Inc. Ms. Roberts previously served as Chief Financial Officer of Mast Therapeutics, Inc. from January 2013 to April 2017, and as its Senior Vice President, Finance, from March 2011 to January 2013. Previously, she held senior positions at Alphatec Spine, Inc., Artes Medical, Inc., Stratagene Corporation, and Pfizer, Inc. Ms. Roberts currently serves as Chair of the Southern California Chapter of the Association of Bioscience Financial Officers and has served on the Board of Temple Therapeutics BV since November 2019. Ms. Roberts is a certified public accountant with the State of California and received her B.S. degree in business administration from the University of Arizona and her M.B.A. from the University of San Diego.

 

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Appointment of Chief Scientific Officer: Today, the Company announced the appointment of Anthony Hickey, Ph.D. as Chief Scientific Officer. Dr. Hickey is Professor Emeritus in Pharmacoengineering and Molecular Pharmaceutics at the Eshelman School of Pharmacy of the University of North Carolina at Chapel Hill. Dr. Hickey is also Adjunct Professor of biomedical engineering at the University of North Carolina (UNC) School of Medicine.

 

TFF Pharmaceuticals also announced that Dr. Brian Windsor has

stepped down from his roles as Chief Scientific Officer and Board member
effective March 21, 2022, to focus exclusively on his role as President and CEO
of Lung Therapeutics.

 

Expands Leadership Team: Today, 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. Koleng has 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, LLC and Axxis Innovations, Inc. John is an industry-recognized expert in drug development including nasal/pulmonary products and injectables. John has an historic relationship working with TFF as a consultant 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 Austin where 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. Davenport brings 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. Davenport willoversee 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 University and received his Ph.D. in Molecular Biology from Howard University.

 

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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 encompassed senior management and technical leadership positions within the U.S. and Europe in both large corporations (VP, Global Regulatory Affairs – Oncology, Johnson & Johnson) and start-up-like entities (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.

 

Strategic Business Development and Partnership Activities – Biopharmaceutical Companies and Research Institutions:

 

oIn March, TFF entered into a collaboration agreement with Catalent focused on providing access to its large number of clients the innovative TFF technology 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 TFF’s biologics collaborations.

 

oIn 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.

 

oIn October, TFF and Augmenta Bioworks announced the publication of a research paper highlighting positive preclinical study results of AUG-3387, a monoclonal antibody (mAb) therapy being developed in collaboration between the two companies for the treatment of SARS-CoV-2 infection. The findings have been published online through the bioRxiv preprint server, under the title “AUG-3387, a Human-Derived Monoclonal Antibody Neutralizes SARS-CoV-2 Variants and Reduces Viral Load from Therapeutic Treatment of Hamsters In Vivo.”

 

Strategic Business Development and Partnership Activities – Governmental and Defense Contracting Agencies: 

 

oIn March, entered into a new Cooperative Research and 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 Pharmaceuticals and 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.

 

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Financial Results 

 

For the year ended December 31, 2021, compared to 2020

 

Cash Position: As of December 31, 2021, TFF Pharmaceuticals reported cash and cash equivalents of $33.8 million.

 

Research and Development (R&D) expenses: R&D expenses for 2021 were $21.3 million, compared to $10.7 million in 2020.

 

General & Administrative (G&A) expenses: G&A expenses for 2021 were $10.6 million, compared to $8.0 million in 2020.

 

Net Loss: TFF Pharmaceuticals reported a net loss for 2021 of $31.0 million, compared to a net loss of $18.6 million in 2020.

 

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

 

Research and Development (R&D) expenses were $6.9 million compared to $3.1 million for the same period in 2020.

 

General & Administrative (G&A) expenses were $3.2 million compared to $2.9 million for the same period in 2020.

 

Net Loss: TFF Pharmaceuticals reported a net loss of $10.0 million, compared to a net loss of $5.9 million for the same period in 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: Inhaled Voriconazole Powder and Inhaled Tacrolimus Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by over 120 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 expectations for its continued development of Inhaled Tacrolimus and Voriconazole Powdersand an Inhaled Niclosamide Powder for the treatment of COVID-19 infection, collaboration and referral arrangement with Catalent, the benefits of the Company’s TFF platform 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 Inhaled Tacrolimus, Voriconazole or Niclosamide Powders or any of its dry powder product candidates, (ii) the risk that the Company may not achieve the favorable results expected from its collaboration and referral agreement with Catalent, ((iii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iv) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (v) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (vi) those other risks disclosed in the section “Risk Factors” included in the Company’s 2021 Annual Report on Form 10-K filed with the SEC on March 24, 2022. 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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Company Contacts:

 

Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc
gmattes@tffpharma.com

 

Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com
 

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

 

1Denning 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 Dec 4. PMID: 23210682. Accessed November 5, 2021.

 

###

 

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TFF PHARMACEUTICALS, INC.

 

Consolidated Balance Sheets
as of December 31, 2021 and 2020

 

   December 31,
2021
   December 31,
2020
 
ASSETS        
Current assets:        
Cash and cash equivalents  $33,794,672   $35,300,805 
Receivable due from collaboration agreement   1,628,703     
Research and development tax incentive receivable   966,646     
Prepaid assets and other current assets   2,447,930    2,258,229 
Total current assets   38,837,951    37,559,034 
Property and equipment, net   1,859,860    1,102,808 
Total assets 

$

40,697,811   $38,661,842 
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable  $1,493,842   $1,297,725 
Accrued compensation   416,910     
Deferred research grant revenue   50,000    24,315 
Total liabilities   1,960,752    1,322,040 
Commitments and contingencies          
Stockholders’ equity:          
Common stock; $0.001 par value, 45,000,000 shares authorized; 25,371,781 and 22,534,874 shares issued and outstanding as of December 31, 2021 and 2020, respectively   25,372    22,535 
Additional paid-in capital   104,078,968    71,648,453 
Accumulated other comprehensive loss   (48,921)   (51,538)
Accumulated deficit   (65,318,360)   (34,279,648)
Total stockholders’ equity   38,737,059    37,339,802 
Total liabilities and stockholders’ equity  $40,697,811   $38,661,842 

 

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TFF PHARMACEUTICALS, INC.

 

Consolidated Statements of Operations
for the years ended December 31, 2021 and 2020

 

CONSOLIDATED STATEMENTS OF OPERATIONS  Year Ended
December 31,
2021
   Year Ended
December 31,
2020
 
Grant revenue  $88,161   $ 
Operating expenses:          
Research and development   21,300,865    10,681,565 
General and administrative   10,573,954    8,012,085 
Total operating expenses   31,874,819    18,693,650 
Loss from operations   (31,786,658)   (18,693,650)
Other income:          
Other income   696,714     
Interest income   51,232    126,416 
Total other income   747,946    126,416 
Net loss  $(31,038,712)  $(18,567,234)
Net loss per share, basic and diluted  $(1.25)  $(0.91)
Weighted average common shares outstanding, basic and diluted   24,820,971    20,425,162 

 

 

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Exhibit 99.2

 

1 Better Delivery, Better Therapy: Powerful Drug Delivery Solutions Corporate Investor Presentation March 2022 Nasdaq: TFFP

 

 

2 Safe Harbor Statement SPECIAL NOTE REGARDING FORWARD - LOOKING STATEMENTS This document contains forward - looking statements concerning TFF Pharmaceuticals, Inc. (“TFF”, the “Company,” “we,” “us,” and “our”). The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward - looking statements. These forward - looking statements include, but are not limited to, statements concerning the following: • our future financial and operating results; • our intentions, expectations and beliefs regarding anticipated growth, market penetration and trends in our business; • the timing and success of our plan of commercialization; • our ability to successfully develop and clinically test our product candidates; and • our ability to file for FDA approval of our product candidates through the 505(b)(2) regulatory pathway. These forward - looking statements are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially. Among those factors are: (i) no drug product incorporating the TFF platform has received FDA pre - market approval or otherwise been incorporated into a commercial drug product, (ii) 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 (iii) those other risks disclosed in the section “Risk Factors” included in the Company’s 20 21 Annual Report on Form 10 - K filed March 24 , 202 2 with the SEC. 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 document contains only basic information concerning TFF. Because it is a summary it does not contain all of the information you should consider before investing. Please refer to our reports and registration statements on file with the SEC for more comprehensive information concerning TFF Pharmaceuticals.

 

 

3 Investment Highlights Experienced Management; IP Protection Four Internal Programs Broadly Applicable Platform Proprietary Pulmonary Drug Delivery Process • Experienced senior management team with outstanding track record of success in a diverse set of competencies and related disciplines. • Robust IP estate with over 120 patents issued or pending • Inhalable voriconazole (VORI) for infections overcomes problem of hepatic/visual toxicity • Inhaled tacrolimus (TAC) for organ transplant has potential to avoid Prograf’s renal toxicity – Phase 2 programs to begin at close of 2021 • Inhaled niclosamide for COVID - 19 and viral infections (w/ Union Therapeutics) currently in Phase I trial • AUG - 3387 mAb for COVID - 19 (w/ Augmenta Bioworks) progressing to human trials • Have established POC for multiple small and large molecules • Significant number of R&D partnerships in place which we believe will lead to licensing transactions of the technology • Thin Film Freezing (TFF) is a u nique, patented technology with proven ability to convert a wide range of poorly absorbed drugs into inhalable dry powder formulations

 

 

4 TFF Leadership • 30 years of business leadership experience in development and commercial launches of global therapeutics • Former CEO of Tibotec Therapeutics, a J&J company, and Rhone - Poulenc Rorer/Canada, and in addition to other senior C - suite positions at Centocor and J&J • Critical roles in launch of J&J’s first two HIV/AIDS therapeutics, as well as other drugs Doxil, Procrit, Remicade, Taxotere and Lovenox • Appointed to the President’s Advisory Council on HIV/AIDS by President George W. Bush and the US Secretary of Health and Human Services • Former CEOs, Institutional fund founder and Board - level roles • Deep functional experience in all areas of healthcare companies • Commercially successful enterprises • Track record of numerous significant exits and transactions Board Of Directors Highly experienced healthcare and life science finance executives Glenn Mattes President & Chief Executive Officer Previous Experience

 

 

5 Scientific Advisory Board David N. Cornfield, M.D. Professor of Pulmonary Medicine, Stanford University Ted M. Ross, Ph.D. Professor, Center for Vaccines and Immunology, Department of Infectious Diseases, University of Georgia Prof. David Denning, FRCP, FRCPath, DCH, FMedSci Professor of Infectious Diseases, University of Manchester Mike Saag, M.D. Professor of Medicine, University of Alabama at Birmingham Drew Weissman, M.D., Ph.D. Roberts Family Professor, Vaccine Research at the Perelman School of Medicine, University of Pennsylvania Jay Peters, M.D. Chief of Pulmonary and Critical Care Medicine, University of Texas Health Science Center at San Antonio

 

 

6 TFF Pipeline – Building value through internal programs Category Platform Formulation Indication Development Stage (& Partners) Recent and Anticipated Milestones Pre - clinical Phase 1 Phase 2 Phase 3 Internal TFF VORI 1 Inhaled Voriconazole (Antifungal) Invasive Pulmonary Aspergillosis (IPA) • Final data from reactive airway study (4Q’21) • End of Phase 1 meeting requested with FDA (4Q’21) • Initiate Phase 2 study ( ~ year - end 2021 ) • Interim Analysis (3Q’22) TFF TAC 2 Inhaled Tacrolimus (Immunosuppresant) Prophylaxis of organ rejection in lung transplant • Six - month tox. and Phase 1 SAD completed (1H‘21) • Final data from Phase 1 (3Q’21) • Initiate Phase 2 study ( ~ year - end 2021 ) • Interim Analysis (3Q’22) TFF NICLO 3 Inhaled Niclosamide (Antiviral) COVID - 19 and other viral infections • CTA Submitted (3Q’21) • Phase 1 first dosing (4Q’21) • Phase 1 expected dosing completion (1Q’22) AUG - 3387 Inhaled mAb COVID - 19 • Animal efficacy studies completed (3Q’21) • Toxicology initiated (1Q’21) • Phase 1 first doing (3Q’22) 1 Pursuing Orphan Drug Designation (ODD) 2 Granted ODD 3 Reformulation work ongoing for oral and inhaled - based delivery

 

 

7 TFF External Pipeline – Leveraging the TFF platform Category Platform Formulation Indication Development Stage (& Partners) Recent and Anticipated Milestones Pre - clinical Phase 1 Partner External Vaccines Inhaled and intranasal delivery Influenza, Ebola, Marburg, COVID - 19 and alphaviruses • In vitro/ in vivo data; leading to first in human trials Phage - based Biotherapeutic Inhaled formulation of complex biologic Antibiotic - resistant bacterial infections • Feasibility complete • Collaboration ongoing Adv Chem/Bio Protection Formulations for skin, eyes, lungs Neutralizing countermeasures • Project initiated and work is on - going Undisclosed Undisclosed Undisclosed Undisclosed • Undisclosed Undisclosed Undisclosed Undisclosed Undisclosed • Undisclosed Undisclosed Undisclosed Undisclosed Undisclosed • Undisclosed Cannabis Inhaled THC/CBD Avoid vaping - based lung injury (N/A) • Market testing of TFF versions of cannabinoids potentially leading to commercial launch in 2022

 

 

8 Thin Film Freezing – Superior Pulmonary Drug Delivery The Problem Our Solution Oral Inhaled Typically, 10% of oral drugs reach their target and often contain bulking agents, fillers, and high dosages contributing to unwanted side effects. Our TFF platform has shown the ability to deliver precise dosages to the site of action in increasing therapy response time and reducing side effects. High Efficacy Decrease in adverse events Low Efficacy Increase in adverse events Drug in the lung = Efficacy

 

 

9 TFF Brittle Matrix Process and Powders Bulk Drug Material Brittle Matrix Powders

 

 

10 TFF Platform Advantages Spray Drying Spray Freeze Drying Nano - Milling TFF Thermal Degradation ✘ x ✘ x Shear Stress ✘ ✘ ✘ x Air/Water Denaturation ✘ ✘ x x Technology Differentiators • Microparticles • Lower yield • Harder processing conditions • Microparticles • Lower yield • Variable particle size (not suitable for DPI) • Cannot handle viscous solutions • Microparticles • Can result in crystalline (insoluble in the lung) • Harsh processing conditions • Nanoaggregate particles (better absorption) • Higher yield • Uniform particle size • Gentle processing (good for labile molecules) Potential To Prevent Molecular Damage Suitability For Dry Powder Inhalers

 

 

11 A Revolutionary Technology Platform – Validated, Scalable, and IP - Protected Clinical validation of TFF Pharma’s internal drug programs • Voriconazole Inhalation Powder (VORI) – Phase 1 trial completed – Final data from reactive airway study in 4Q’21 (completed) – Pursuing ODD*; Phase 2 trial initiating; Interim Analysis 2H 2022 • Tacrolimus Inhalation Powder (TAC) – Phase 1 trial completed – Phase 1 data in 3Q’21 (completed) – Granted ODD; Phase 2 trial initiating; Interim Analysis 2H 2022 Industry - validated with robust BD activity • Numerous finished formulations of small molecules & biologics; multiple R&D partnerships, and growing portfolio of opportunities Scalable, IP - protected platform • Manufacturing drugs for clinical studies using GMP standards; strategic partnership with UT Austin for smaller - scale, BD work • Strong IP portfolio: protection covering TFF process, multiple drug opportunities, and internal products * Orphan Drug Designation (ODD)

 

 

12 GMP Manufacturing Readiness • TFF partnered with CoreRx and IriSys to manufacture non - clinical and clinical trial supplies for VORI and TAC. CoreRx has capacity to support long - term commercial supplies. Third CRO, Experic, to install Thin Film Freezing GMP processing line and specialized associated capabilities. • Working with Catalent to produce the Augmenta mAb, AUG - 3387 and other biologics, some requiring aseptic fill and finish • TFF process scale currently in place to support material needs through Phase 2 clinical trials. Development capability at UT Austin continues to function well to support business development opportunities and product scouting. • Currently identifying equipment and vendors to encapsulate TFF powders at increased speed and scale to support increasing clinical supply needs and registration/early commercial requirements.

 

 

13 Two - pronged Strategy For Leveraging TFF Formulations and Maximizing Value In - house Development Identify opportunities that address significant unmet medical need, and/or lower risk clinical pathway via 505(b)(2): – TFF Voriconazole (VORI) for IPA/ABPA – TFF Tacrolimus (TAC) for lung transplant as well as kidney, heart and liver – TFF Niclosamide for COVID - 19 and viral infections in first - in - human trials – Augmenta/TFF mAb development for COVID - 19 Pharma Licensing Platform Pursue R&D collaborations to provide direct - to - lung, intranasal, topical and intra - ocular delivery for oncology, COPD, PAH, CF, biologics, and combinations in multiple therapeutic indications. Potential licensing opportunities include: – Academic vaccine partnerships – University of Georgia, Albert Einstein College of Medicine, University of Pennsylvania – National priority biodefense vaccines and countermeasures – USAMRIID, DARPA, and LEIDOS – Bacteriophage - based biotherapeutic – Felix Biotechnology – Cannabis market opportunity – PLUS Products TFF Business Model

 

 

14 Voriconazole Inhalation Powder (TFF VORI) • IV/Oral voriconazole indication and side effects • TFF VORI preclinical and clinical data highlights • Clinical development plan and near - term data readouts • Market opportunity Target Indications: Invasive Pulmonary Aspergillosis (IPA) Allergic Bronchopulmonary Aspergillosis (ABPA)

 

 

15 Targeted indication: Acute and chronic treatment of adults and pediatric patients 2 years - of - age and older with invasive pulmonary aspergillosis (IPA) and allergic bronchopulmonary aspergillosis (ABPA) and prophylaxis of IPA Preclinical POC data: • 3X better survival vs. amphotericin in IPA Phase 1 data: • Dosages up to 80mg twice daily showed no signs of the clinically significant hepatic or visual toxicities previously reported for the oral or intravenous forms Approved Indication: Treatment of patients 12 years or older with invasive aspergillosis Side Effects: • Hepatic toxicity, including clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities * • Visual disturbances, including optic neuritis and papilledema * Alternatives: Oral and IV amphotericin, echinocandins, azoles IV/oral voriconazole Clinical development strategy : expand treatable patient population with improved safety profile, while lowering clinical development risk by focusing on pulmonary infections only TFF VORI TFF VORI Program (Inhaled Voriconazole) * Voriconazole Package Insert; Warning and Precautions section, 5.2 and 5.3

 

 

16 IV/Oral voriconazole (insert data chart and note if data have been presented/published) TFF VORI Preclinical and Clinical Data To Date • 13 - week tox supportive of clinical approach • 26 - week tox study under way to support registration • SAD/MAD Completed with doses up to 80 mg BID for 7 days • No Clinically Significant Adverse Events • 80 mg dose selected for Phase 2 • Nebulized VORI efficacious at 40 mg BID Preclinical Data Phase 1 Clinical Data Published Clinical Data with Inhaled Voriconazole Phase 2 Clinical Trial

 

 

17 2021 inflection points and catalytic events • 13 - week toxicology study complete (2Q’21) • Final data from reactive airway study (4Q’21) • Initiated Phase 2 study (1Q’22) Market opportunity and payor access* • Antifungal sales topped $4B 1 . However, an inhaled voriconazole for IPA and ABPA and unmet medical needs could achieve blockbuster status • Market: IPA* - 40K US annually representing >$300MM 4 opportunity • Once TFF VORI demonstrates a safety advantage, payer respondents said they would be covered no matter the cost* • $300MM in potential peak sales worldwide • Assuming acute IPA penetration of 18%; at risk penetration 2% TFF VORI revenue forecast* TFF VORI Outlook * Trinity (third part market research firm); “TFF Forecast Update: TFF Tac - Lac and TFF VORI ; Final Report – Updated”; May 5th, 2021

 

 

18 Tacrolimus Inhalation Powder (TFF TAC) • IV/oral tacrolimus indication and side effects • TFF TAC preclinical and clinical data highlights • Clinical development plan and near - term data readouts • Substantial market opportunity Target Indication: Prophylaxis of organ rejection in patients receiving lung transplants

 

 

19 Targeted Indication: Prophylaxis of organ rejection in patients receiving lung transplants Preclinical POC Data: Rat lung transplant, asthma, peer - reviewed Clinical Safety Data: • Successfully completed single and multiple ascending dosing of four cohorts of healthy subjects in Phase 1 trial • Well tolerated with no reports of clinically significant drug - associated adverse events • Single dose provides substantial systemic blood levels that approach levels associated with effective immunosuppression in heart, lung, kidney and liver transplant patients. Clinical development strategy: To differentiate inhaled tacrolimus based primarily upon improved safety and fewer drug - drug interactions compared to oral tacrolimus TFF TAC TFF TAC Program (Inhaled Tacrolimus) * Tacrolimus (PROGRAF ® ) Package Insert; Warning and Precautions section, 5.2 through 5.8 Approved Indication: Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, lung or heart transplants Side effects: Development of lymphoma and other malignancies, serious infections, polyoma virus infections, cytomegalovirus infections, new onset diabetes, nephrotoxicity, neurotoxicity* Alternatives: Oral and IV immunosuppressants IV/oral Tacrolimus

 

 

20 IV/Oral voriconazole TFF TAC Preclinical and Clinical Data To - Date • 26 - week tox complete • NOAEL established • 3 - 4 - fold higher lung exposure than blood • SAD doses of 0.5, 1.0, 2.5, and 5.0 mg • No food effect observed (2.5 mg cohort) • MAD doses of 0.5 and 1.0 mg BID and 1.5 mg QD • MAD dosing accumulates to therapeutic levels Preclinical Data Phase 1 Clinical Data

 

 

21 TFF TAC Outlook * Trinity Partners (third party market research firm); “TFF Forecast Update: TFF Tac - Lac and TFF VORI ; Final Report – Updated”; May 5th, 2021 ** Granted Orphan Drug Designation 2021 inflection points and catalytic events • Six - month toxicology study completed (1Q’21) • Phase 1 SAD dosing completed (2Q’21) • Phase 1 MAD dosing complete, final data (3Q’21) • Phase 2 initiated (1Q’22) Market opportunity and payor access* • Total transplant addressable market: >$1B 5 • Once TFF TAC demonstrates a safety advantage, payer respondents said they would be covered no matter the cost** • $400MM worldwide for first indication • Assuming 27% penetration • Global forecast including heart, liver, and kidney transplant exceeds $1 billion TFF TAC revenue forecast*

 

 

22 x Q1 TAC: 6 - month tox completed, Phase 1 SAD dosing complete NICLO: Pre - IND submission, oral tox study start x Q2 VORI: 13 - week tox complete; release of Phase I data NICLO: Inhaled tox study start, oral tox complete x Q3 VORI: 26 - week tox study initiated TAC: Phase 1b topline data AUGMENTA: Preclinical efficacy data NICLO: CTA filing completed x Q4 VORI: results from Phase 1b reactive airway study; AUGMENTA: Animal studies complete; formulation finalized NICLO: Phase 1 dosing initiated 2021 Clinical Catalysts: Including NICLO and AUGMENTA

 

 

23 Q1 VORI: Phase 2 – initiation TAC: Phase 2 – initiation Niclo: Phase 1 – Completion of Phase 1 Aug: CMC – engineering run complete, Initiation of tox study Q2 VORI: Phase 2 – study ongoing TAC: Phase 2 – study ongoing Niclo: IND filing for Phase 2 start* Aug: GMP mAb Drug Substance Manufacturing complete Q3 VORI: Phase 2 – study ongoing, Interim Analysis TAC: Phase 2 – study ongoing, Interim Analysis Niclo: Phase 2 – initiation* Aug: Phase 1 – initiation Q4 VORI: Phase 2 – study complete TAC: Phase 2 – study complete Niclo: Phase 2 – study ongoing* Aug: Phase 1 – study complete 2022 Expected Clinical Catalysts * Transition to Union Therapeutics

 

 

24 Business Development - The Power of the TFF Platform Under Consideration for Potential Development by TFF Government/ Academic Partnerships CRADA agreement with USAMRIID t o formulate dry powder neutralizing antibodies against national priority biodefense threats LEIDOS/DARPA contract R&D collaboration with the University of Georgia, Albert Einstein College of Medicine, and UPenn using TFF platform for a dry powder universal influenza vaccine Botanicals Thin Film Freezing technology can effectively convert these compounds into a dry powder inhalation form, which can result in a rapid onset of action, with peak blood levels in minutes and with very positive bioavailability and absorption attributes New Chemical Entities (NCEs) Open MTAs with multiple pharma partners formulating new product opportunities in both small and large molecules Partnerships focused on Platforms mRNA sRNA Macrophage mAbs Peptides Peptoids Vaccines Reformulation and development of new vaccines eliminating need for cold chain supply requirements Ongoing discussions with multiple global pharma companies to test their proprietary compounds using the TFF technology platform

 

 

25 Disclosed Collaboration Partners

 

 

26 Vaccine Programs R&D to evaluate Thin Film Freezing technology to formulate dry powder universal influenza vaccines for pulmonary delivery with one of the world’s leading research institutions in vaccine development • Collaboration between TFF, UT Austin and University of Georgia’s world renowned Center for Vaccines and Immunology (CVI), lead by Ted Ross, Ph.D., Professor | of Infectious Diseases at UGA. • UT Austin will formulate hemagglutinin (HA) and neuraminidase (NA) proteins using TFF technology, and Univ. of Georgia CVI will evaluate these formulated compounds to elicit broadly reactive immune responses and potentially provide longer - lasting protection against a wider variety of influenza viruses. 26 Cooperative Research and Development Agreements (CRADA) with nation’s top biodefense lab on dry powder vaccines for several of the world’s deadliest viruses including Ebola, Marburg and a number of Alphaviruses • Lead by Dr. John Dye, USAMRIID's chief of viral immunology, one of the scientists responsible for the development of the Ebola vaccine, this 3 - year collaboration between TFF and US Army will investigate Thin Film Freezing to formulate two different countermeasures, a monoclonal antibody against Alphaviruses and a vesicular stomatitis virus vaccine against Filoviruses. • The development of biodefense countermeasures that are potentially more easily administered via a pulmonary or intranasal route, and are temperature stable, could be an important advantage in environmentally hostile combat situations.

 

 

27 Monoclonal Antibodies and Antivirals for COVID - 19 Worldwide Joint Development Agreement for COVID - 19 monoclonal antibody therapies with Augmenta Bioworks. Collaboration on first - of - its - kind uses of Thin Film Freezing technology applied to monoclonal antibodies (mAbs) • Joint Development Project to develop one or more commercial therapeutics based on, derived from, and/or incorporating Augmenta’s human mAbs to potentially treat patients with COVID - 19. AUG - 3387 selected to move forward into human testing. • 50 - 50 split of all expenses, and potential revenues and future cash payments. TFF Pharmaceuticals, UT Austin, and Union Therapeutics are reformulating niclosamide for inhaled delivery • Niclosamide (used since the 1960’s) is more potent when compared with other drugs such as chloroquine, lopinavir and remdesivir, but it is poorly absorbable when delivered orally. • TFF - developed inhaled formulation of niclosamide.

 

 

28 Next - Gen Chemical and Biological Protection 28 Thin Film Freezing platform to be used to rapidly neutralize chemical and biological threats at vulnerable tissue barriers to increase soldier protection and decrease operational burden under DARPA’s Personalized Protective Biosystems (PPB) Program • Leidos subcontract overseen by DARPA 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 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. • Successful PPB technologies could change how the military and public health communities perform in unpredictable threat environments.

 

 

29 Bacteriophage - based Biotherapeutic 29 Letter of Intent for a Collaboration, Development and License Agreement. Felix Biotechnology would obtain worldwide license for T FF technology to develop a novel, bacteriophage - based biotherapeutic • In exchange for TFF technology license, Felix would agree to pay TFF Pharmaceuticals an upfront payment, development milestones, commercial milestones worth up to $281 million, along with royalties on net sales of the Felix biotherapeutics. • TFF r eformulation of these unique, complex biologics i s a first - of - its - kind breakthrough for a potentially more effective and targeted delivery to the deep lung of patients. Opportunity in Cannabis Market To develop a THC/CBD inhalation product without carriers or ingredients associated with vaping lung injury, with a high consumer satisfaction experience, rapid onset of activity and consistent delivery • TFF can generate dry power inhaled versions of cannabinoids with lung friendly ingredients. • Cannabinoid powders do not rely on the use of oils or liquid carriers to deliver the dose. Inhalation of the powder is achieved with a reusable passive dry powder inhaler device that does not require batteries or charging. • Direct lung delivery as a powder leads to rapid onset of action; market testing underway.

 

 

30 Collaborations Collaboration with Pfizer to evaluate the Thin Film Freezing technology with multiple proprietary drug candidates of Pfizer • TFF to formulate and perform feasibility testing on multiple Pfizer drug candidates utilizing TFF’s proprietary thin film freezing technology • Pfizer’s proprietary drug candidates and the financial terms of the arrangement are undisclosed 30 Collaborative Research Agreement (CRA) with Dr. Drew Weissman at the Perelman School of Medicine at the University of Pennsylvania • Led by Dr. Drew Weissman, the world - renowned leading mRNA expert and inventor of the Pfizer/BioNTech and Moderna COVID - 19 vaccines, TFF and Dr. Weissman are testing UPenn’s mRNA vaccines from a frozen liquid into a dry powder version utilizing TFF’s thin - film freezing technology to evaluate the potency & immunogenicity of the TFF processed mRNA vaccines • The TFF dry powder formulations of the mRNA - LNPs will be formulated and tested to improve stability, generate room temperature storage and explore new routes of administration, oral & nasal inhaled delivery • Dr. Drew Weissman is a member of TFF’s Scientific Advisory Board

 

 

31 TFF Pharma – Catalent Collaboration Agreement 31 Catalent will introduce their customer base to TFF’s proprietary and innovative Thin Film Freezing technology Catalent to provide CDMO services to any referred client that licenses and partners TFF technology Collaboration focused on development of dry powder formulations of therapies, specifically biologics, for inhalation to the lungs and nose and/or reconstitution for injection Focuses of agreement: • Generation, testing and manufacturing of dry powder formulations of biologics, including but not limited to: • mRNA, siRNA, ncRNA • monoclonal antibodies, antibody fragments, antibody conjugates, proteins, peptides • Phage, AAV, VLP, gene and cell therapies • TFF and Catalent will share in revenues generated from future commercialized products from agreement

 

 

32 Key Takeaways Revolutionary platform enabling inhalable drug delivery across the entire spectrum of pharmaceutical agents (small & large molecules, biologics, vaccines, mRNA), targeting multiple $Billion - plus markets Two proprietary, high commercial and lower risk clinical programs (TFF VORI & TFF TAC) with significant near - term data readouts; both with accelerated 505(b)(2) regulatory pathway Growing business development and partnering activity as industry increasingly recognizes the clinical and commercial potential of TFF technology Strong patent portfolio : TFF process, drug opportunities, new IP development Cash : $33M as of 12/31/21; sufficient runway into 2023 Proven management team, with multiple successful exits

 

 

33

 

 

34 ENDNOTES 1. Antifungal Market Growth - 2013. Global Data Research Report https://www.globaldata.com/ (last accessed February 15, 2019). TFF Pharmaceuticals Estimates Q1 2019 2. Growth of Global Immunosuppressant Market for Acute Rejection - 2013. Global Data Research Report https://www.globaldata.com/ (last accessed January 10, 2019). 3. COPD Market Growth – 2017. Global Data Research Report https://www.globaldata.com/ (last accessed February 22, 2019). 4. APBA Annual Market Growth, TFF Pharmaceuticals Estimates Q1 2019. 5. Lung Transplant Addressable Market Growth, TFF Pharmaceuticals Estimates Q1 2019. 6. Severe Asthma Market Growth - 2015. Global Data Research Report www.globaldata.com/ (last accessed February 20, 2019). TFF Pharmaceuticals Estimates Q1 2019