TFF Pharmaceuticals : Corporate Presentation

Advanced Technology for Better Drug Delivery Options

C o r p o r a t e P r e s e n t a t i o n 2 0 1 9

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, including those described in the "Risk Factors" section of the Registration Statement on Form S-1 filed by TFF with the Securities and Exchange Commission on August 20, 2019. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this document may not occur and actual results could differ materially and adversely from those anticipated or implied in our forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur.

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.

TFF has filed a registration statement (including a prospectus) with the SEC for the offering to which this communication relates. Before you invest, you should read the prospectus in that registration statement and other documents TFF has filed with the SEC for more complete information about TFF and this offering. You may get these documents for free by visiting EDGAR on the SEC Web site at www.sec.gov. Alternatively, TFF, any underwriter or any dealer participating in the offering will arrange to send you the prospectus if you request it by calling National Securities Corporation toll-free at 833-737-4357.

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C O M P A N Y O V E R V I E W

• The Thin Film Freezing platform converts poorly absorbed drugs into inhalable dry powder drugs in multiple $Billion markets
• Expect two NDA filings within 34 months at clinical and development cost of $27MM
• CEO Glenn Mattes is an experienced pharma industry executive
  (Centocor, Johnson & Johnson, Rhone-Poulenc Rorer)
• TFF has two product candidates under development and several business development opportunities
• Robust IP estate including 36 patents issued and/or pending

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TFF LEADERSHIP

GLENN MATTES

President & Chief Executive Officer

• 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

BOARD OF DIRECTORS

Highly Experienced Healthcare Executives

• Former CEO and Board level roles
• Deep functional experience in all areas of healthcare companies
• Commercially successful enterprises
• Track record of numerous significant exits and transactions

PREVIOUS EXPERIENCE

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P R O B L E M

Poorly Absorbed Drugs Missing the Target:

Many drugs intended for one organ, especially therapeutics intended for lung conditions, often don't reach their target due to poor absorption. This can cause poor efficacy and serious safety concerns. This is true not only for lung conditions but also applies to many therapeutic and medicinal categories.

Advanced Technology for Better Drug Delivery:

One solution to this problem would be to make these drugs inhalable. However, due to poor water solubility, not every drug can be formulated and delivered in this manner.

We believe biologics, the fastest growing segment of the pharma industry, and combination drugs are especially poorly-suited

to the inhalable format using today's inhalation technology.

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THIN FILM FREEZING

A REVOLUTIONARY PLATFORM FOR

ENABLING INHALABLE DRUGS

Industry-validated,peer-reviewed and scalable platform

• Platform has been tested in a clinical setting
• More than a dozen finished formulations of high value drugs, both small molecules & biologics
• TFF is manufacturing drugs for clinical studies using GMP standards
• Strong IP portfolio: TFF process, multiple drug opportunities, internally-developed products
• Pursuing global orphan drug designations

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THIN FILM FREEZING

A REVOLUTIONARY TECHNOLOGY FOR ENABLING INHALABLE DRUGS

Two NDA filings expected within 34 months

Initial NDA Filing (TFF VORI)

• Expected in 31 months via 505(b)(2) pathway

Second NDA Filing (TFF TAC)

• Expected in 34 months via 505(b)(2) pathway

TFF Triple Combo

• Targets COPD; Pursuing Big Pharma Collaboration

Business Development

• Broad array of TFF platform applications and partnership opportunities

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MULTIPLE LARGE TARGET MARKET OPPORTUNITIES

TFF VORI	TFF TAC	TRIPLE COMBO
• Antifungal sales topped $4B1	• Global immunosuppressant	• COPD market $10B annually
	market for acute rejection	(2015) going to $14B (2025)3
	$15B2 annually by 2023

Business Development

• Dozens of off-patent drug targets, many addressing markets of $100 to $500 million
• Numerous other opportunities, including enabling NCE's, across therapeutic categories

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DRUG/EXCIPIENT	RAPID-FREEZING ON	SOLVENT REMOVAL	POWDER FILLING	COMMERCIALIZED
IN SOLUTION	A CRYOGENIC DRUM	BY LYOPHILIZATION	IN CAPSULE	PRODUCT

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TFF PLATFORM ADVANTAGES

POTENTIAL TO PREVENT

MOLECULAR DAMAGE:

YES	NO	YES	YES
YES	YES	YES	NO
YES	NO	NO	YES

SUITABILITY FOR DRY

POWDER INHALERS:

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GMP MANUFACTURING READINESS

• TFF has engaged Core Rx and Irisys to manufacture
  GMP batches of VORI and TAC for clinical trials and is in discussions with Patheon for a long-term commercial manufacturing agreement
• TFF process scale supports Phase I/II supply needs and business development
• Supplies for 28-day GLP studies successfully manufactured
• Analytical methods for GLP studies validated

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TFF BUSINESS MODEL

1. TWO-PRONGEDSTRATEGY FOR LEVERAGING TFF FORMULATIONS AND MAXIMIZING VALUE

IN-HOUSE DEVELOPMENT

• TFF VORI for ABPA/IPA
• TFF TAC for lung transplant and severe asthma
• Additional pipeline assets in early development, one provisional patent already filed

PHARMA LICENSING PLATFORM

• Pursue R&D Collaborations to provide direct-to-lung delivery for oncology, COPD, PAH, CF, biologics, and combinations
• Enhance large pharma's patent position on already marketed drugs - 18 potential candidates already identified
• Compelling indications include insomnia, migraines, PAH, vaccines, and medicinal use of cannabinoids

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VORICONAZOLE INHALATION POWDER TARGET INDICATIONS

Voriconazole Inhalation Target Indications:​

Voriconazole Inhalation Powder is an azole antifungal being developed for the treatment of adults and pediatric patients 2 years of age and older with:​

• Invasive Pulmonary Aspergillosis​ (IPA)
• Allergic Bronchopulmonary Aspergillosis (ABPA)​

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• Advantages over alternatives: Reduced side effects; direct to site

		of infection
	• Alternatives: Oral and IV Amphotericin, Voriconazole and other
TFF VORI
	Azoles, Candins
Well tolerated, 3X better	•	Markets:
survival in pre-clinical testing		• Antifungal sales topped $4B1. However, an inhaled voriconazole for
		ABPA and unmet medical needs could achieve blockbuster status
		• Market: IPA* - 40K US annually representing >$300MM4 opportunity,
		ABPA - $1B annually4
	• Safety: Well tolerated, 28-day tox studies completed. IND
		enabling tox studies completed
	• Phase I trials expected to begin October 2019
	• Proof of Concept: For IPA, 3X better animal survival
		vs. Amphotericin in preclinical animal testing
	•	Approximately $11MM to get to an NDA filing by Q1 2022

*Orphan Drug Opportunity for TFF

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TACROLIMUS INHALATION POWDER TARGET INDICATION

Tacrolimus Inhalation Powder Target

Indication:​

Either alone or in combination, Tacrolimus Inhalation Powder is being developed for the prophylaxis of organ rejection in patients receiving lung transplants.

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	• Advantages over alternatives: Reduced side effects; direct to site
	• Alternatives: Oral and IV immunosuppressants
TFF TAC
•	Markets:
ALREADY SHOWN TO BE
	• Lung Transplant addressable market: >$1B5 *
SAFE IN HEALTHY HUMANS
	• Severe Asthma >$1B6 annually, growing to $5.3B6 by 2023
	•	Safety:
		• Rat: well tolerated 28 days, high dose tolerance
		• Well tolerated by 20 healthy humans (peer-reviewed article)
	•	Proof of Concept:
		• Rat lung transplant, asthma
		• Peer-reviewed study
	•	Approximately $15MM to get to an NDA filing by Q2 2022

*Orphan designation

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TFF VORI AND TFF TAC SALES WORLDWIDE

TFF VORI*

• $160MM in potential net peak sales worldwide
• Assuming acute IPA penetration of 18%; at risk penetration 2%

TFF TAC*

• $400MM in potential net peak sales worldwide
• Assuming 27% penetration

MARKET ACCESS CONSIDERATION

Once TFF VORI and TFF TAC demonstrate a safety advantage, payer respondents said they would be covered no matter the cost.

*Forecasted

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BUSINESS DEVELOPMENT -

The Power of TFF Platform

• Pursuing R&D Collaborations to provide direct-to-lung delivery for oncology, COPD, PAH, CF, biologics, combinations, and others
• Enhance large pharma's life cycle on already marketed drugs - 18 potential candidates already identified
• Compelling indications include insomnia, migraines, PAH, vaccines, and medicinal use of cannabinoids

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PHARMA TARGET PARTNERS

Active discussions continuing with the following pharma targets on potential collaborations:

Ongoing discussions with the following pharma partners:

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CBD TARGET PARTNERS

Active discussions continuing with the following medicinal and/or Rx partners on potential collaborations:

Ongoing discussions with the following medicinal and/or Rx partners:

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INTERNAL POTENTIAL PROGRAMS

UNDER CONSIDERATION FOR POTENTIAL DEVELOPMENT BY TFF

Existing known

compounds

already delivered

to the lung

Currently

Evaluating:

• PAH

Potential Others:

• COPD treatments
• CF treatments
• Respiratory distress syndrome

Existing known compounds non- lung delivered

Currently

Evaluating:

• AAT for AAT deficiency

Potential Others:

• Migraine
• Insomnia
• Parkinson's

Reformulation of		New Chemical
Vaccines		Entities

Ongoing		In preliminary
discussions with		discussions with a
multiple global		global
pharma		pharmaceutical
companies to		company to
potentially		potentially test
reformulate their		one of their
existing vaccines		proprietary
into dry powder		compounds in the
formulations for		TFF platform.
reconstitution on
site.

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VORI AND TAC - INFLECTION POINTS/CATALYTIC EVENTS

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USE OF PROCEEDS

• Pre-clinicaldevelopment, analysis & preparation; completion of Phase I and Phase II studies
• Invest selectively in potential expansion products
• Highly selective expansion of TFF core team
• Continue and expand business development opportunities
• Continue manufacturing of cGMP batches for clinical trials of TFF VORI and TFF TAC

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OFFERING DETAILS

Proposed Offering	With Over-allotment
Option

Proposed Price per Share	$5.00	$5.00
Shares Offered	4.4 million	5.1 million
Gross Proceeds	$22 million	$25.3 million
Shares Outstanding Post-Offering	17.9 million	18.6 million
Implied Market Cap Post-Offering (at $5 per share)	$89 million	$93 million

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K E Y

T A K E A W A Y S

• Revolutionary platform for enabling inhalable drugs
• Multiple $Billion+ markets
• GMP manufacturing established for clinical trials with leading CMO partners
• Accelerated 505(b)(2) regulatory pathway
• Two NDA filings for approximately $27MM clinical cost
• Broad array of business development initiatives
• Proven team, multiple significant exits
• Strong patent portfolio: TFF process, drug opportunities, new IP development

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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 https://www.globaldata.com/(last accessed February 20, 2019). TFF Pharmaceuticals Estimates Q1 2019

IMAGE CITATION:

Slide 6 - CHEST, Volume 144, Issue 4, Table of Contents, October 2013.

Article Title, "Safety and Tolerability of Single Dose Inhaled Dry Powder Tacrolimus in Healthy Subjects"

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T H A N K Y O U

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TFF EXECUTIVE TEAM

GLENN MATTES PRESIDENT & CHIEF EXECUTIVE OFFICER

• 30 years of business leadership experience in development and commercial launches of global therapeutics
• Former CEO of publicly traded Arno Therapeutics, and senior positions with Tibotec Therapeutics, a J&J operating company, and Rhone- Poulenc Rorer

• 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

KIRK COLEMAN CHIEF FINANCIAL OFFICER

• Joined TFF Pharmaceuticals as Chief Financial Officer January 2018
• 20 years of experience in venture capital investments
• Former executive officer of Steelhead Capital Management, LLC and

Bios Partners, LP, venture capital firm focused on investment in early- stage and growth-stage biotech and medical device companies

• Treasurer for EFO Holdings, LP

BRIAN WINDSOR, PH.D. BOARD MEMBER AND CSO

•	18 years management of biotech companies	• Oversaw in-licensing of TFF to Lung Therapeutics, Inc
• President of Enavail, led work on TFF platform. Managed	• CEO of Lung Therapeutics, Inc
	all development efforts for 10 life science companies at
	Emergent Technologies

A1

STEPHEN ROCAMBOLI

• Strategic business consultant and legal counsel to life science entrepreneurs, companies and investors throughout the world

• Expertise in corporate strategy and finance, partner transactions and operations initiatives

TFF BOARD OF DIRECTORS

AARON FLETCHER, PH.D. CHAIRMAN OF THE BOARD

BOB MILLS BOARD MEMBER

• Founder of Bios Research, Managing
  Partner of Bios Partners
• Lead investor in 8 early-stage life science firms, including Encore Vision ("EV")

• Led origination & closing of sale of EV to Novartis for $375MM plus substantial potential milestone payments
• Director, Lung Therapeutics, Inc

• 39-year pharmaceutical industry veteran		Rhone-Poulenc Rorer
with expertise across GMP Operations,	• Substantial business development
Clinical Research, Regulatory Affairs, R&D,
	experience with multiple product
Product Development and Manufacturing.		acquisitions, joint ventures and product
• Former President and CEO of Scientific
	divestitures
Protein Labs; President, Qualitest	•	Successful track record with the FDA,

HARLAN F. WEISMAN, M.D. BOARD MEMBER

Pharmaceuticals; CEO, Columbia

market share expansion and new

Laboratories, Inc; Alpharma, Inc.; and	product launches

• Senior healthcare executive with 30 years experience in the launch of pharmaceutical products
• Currently Managing Director of And- One Consulting, LLC, advising medical product companies, investment firms, and government and non-government healthcare organizations in innovation

strategies for healthcare products and services

• J&J senior executive for more than
  20 years
• Recognized authority on medical product development and healthcare policy.

BOARD MEMBER

• Chief Business Officer, Advantagene;

Senior Managing Director & General

Counsel, Paramount BioCapital;

President, Pear Tree Pharmaceuticals

RANDY THURMAN BOARD MEMBER

• Board Member of Cortice BioSciences and Androvia Life Sciences

• 30 years in executive leadership, M&A and corporate governance in healthcare technology, biopharma, medical devices and clinical diagnostics
• Global experience in Europe, Asia, Middle East and Latin America

• Former Director & President, Rhone- Poulenc Rorer Pharmaceuticals, and Chairman/CEO positions with Corning Life Sciences and VIASYS Healthcare, Inc
• Currently Executive Chairman, Outlook Pharmaceuticals, Inc

A2

TFF VORI: CLINICAL

DEVELOPMENT PLANS

Clinical Trial Plans

Phase I - SAD/MAD Trial in normal healthy volunteers

• Endpoints: Safety, tolerability and pharmacokinetics
• Single Ascending Dose (SAD)
• • 4 cohorts with 6 active + 2 Placebo (6 + 2 design)
  • 10, 20, 40, and 80 mg dose levels
• Multiple Ascending Dose (MAD)
• • 14-daydosing twice daily
  • 4 cohorts with 6 + 2 design

Phase 2 - Dose finding efficacy study in Invasive Pulmonary Aspergillosis patients

• Administer 40 or 80 mg of TFF VORI for BID up to 3 months
• Endpoints: Safety, tolerability, pharmacokinetics, and efficacy
• Adaptive design with interim analysis to select and expand optimal dose cohort
• Potential for registration

A3

TFF VORI DEVELOPMENT TIMELINE

Total Amount: Approximately $11MM

Additional scenarios exist that include the possibility of longer durations, costs, efforts, and/or even FDA denying use of 505 (B)(2) application, although TFF believes the above timeline to be reasonable and most relevant based on current understandings and expectations. A4

TFF TAC: CLINICAL

DEVELOPMENT PLANS

Clinical Trial Plans

Phase I - SAD/MAD Trial in normal healthy volunteers

• Endpoints: Safety, tolerability and pharmacokinetics
• Single Ascending Dose (SAD)
• • 4 cohorts with 6 active + 2 Placebo (6 + 2 design)
  • 0.5, 1.0, 2.5 and 5.0 mg dose levels
  • 2.5 mg cohort gets a second dose with food to study food effect on PK
• Multiple Ascending Dose (MAD)
• • 14-daydosing twice daily
  • 2 cohorts with 6 + 2 design
  • 2.5 and 5.0 mg dose levels anticipated
• MAD (30-day) in Lung Transplant Patients
• • Administer 2.5 or 5.0 mg of TFF Tac and adjust oral tac dose to achieve therapeutic levels in blood Phase 2b/3a - Proof of Concept in in Lung Transplant Patients (6 months of treatment)
• Administer 2.5 or 5.0 mg of TFF Tac with required oral tac dose to achieve therapeutic levels in blood
• Endpoints: frequency of acute rejection events, safety, tolerability, pharmacokinetics
• Adaptive design with interim analysis to select and expand optimal dose cohort
• Potential for registration

A5

TFF TAC

DEVELOPMENT TIMELINE

Total Amount: Approximately $15MM

Additional scenarios exist that include the possibility of longer durations, costs, efforts, and/or even FDA denying use of 505 (B)(2) application, although TFF believes the above timeline to be reasonable and most relevant based on current understandings and expectations. A6

TRANSFORMATION SINCE SERIES A

• Completed / completing pre-clinical toxicology programs in support of VORI and TAC IND filings
• Secured GMP site manufacturing support for VORI and TAC phase I & II campaigns
• Technical assessment of TFF enabling technology on CBD and vaccine portfolio extensions
• Secured TAC Pre-IND meeting date (Sept. 26). Submitted briefing document to FDA
• Advanced business development / partnership discussions
• Added two clinical advisors (Jay Peters, MD - University of Texas and Harold
  Smith, PhD - University of Rochester)
• Expanded IP portfolio
• Prepared VORI orphan application for US & EMEA

A7

Robert O. (Bill) Williams III, Ph.D., University of Texas

Scientist, Researcher and Inventor

Dr. Williams' research interests include development of novel drug delivery systems for oral, pulmonary, nasal, injectable, buccal and topical administration, as well as the development of novel particle engineering technologies. His research devotes significant effort to enhance drug solubility and dissolution through novel technologies, including thin film freezing and precipitation processes, and thermal processes.

• Professor and head of The University of Texas at Austin College of Pharmacy's Division of Molecular Pharmaceutics and Drug Delivery
• Named the 2017 Inventor of the Year by the university's Office of Technology Commercialization. The prestigious award honors a researcher whose discoveries have made a significant impact in commercialized technologies
• 35 issued and pending patents in the fields of drug delivery, processing and biotechnology
• Johnson & Johnson Centennial Chair
• Fellow of the American Association of Pharmaceutical Scientists (AAPS) since 2006
• Fellow of the American Institute of Medical and Biological Engineering in 2008
• Has published more than 400 peer-reviewed research articles, reviews, abstracts and book chapters
• Co-editedtwo books in the fields of pharmaceutical technology and drug delivery, including "Formulating Poorly Water Soluble Drugs," Second Edition (AAPSPRESS and Springer)
• Editor-in-Chiefof AAPS PharmSciTech
• Serves on the editorial advisory board of The Journal of Drug Delivery Science and Technology (Elsevier)
• Co-foundedseveral pharmaceutical companies

A8