8-K

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 27, 2024

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)

(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 Capital Market

Item 7.01 Regulation FD Disclosure.

On March 27, 2024, the Company issued a press release and published an investor presentation on its website at https://tffpharma.com/investors/ and intends to utilize the presentation in connection with a clinical update call on March 27, 2024. Copies of the press release and investor presentation are attached as Exhibits 99.1 and 99.2 hereto.

The information in this Item 7.01, including the press release and investor presentation attached as Exhibits 99.1 and 99.2, are furnished pursuant to Item 7.01 but 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, nor shall either be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits Method Filing

The following exhibit is furnished with this report:

Exhibit 99.1	Press release dated March 27, 2024	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)

1

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 27, 2024	/s/ Kirk Coleman
	Kirk Coleman,
	Chief Financial Officer

2

EX-99.1

Exhibit 99.1

TFF Pharmaceuticals Announces Updated Data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) Clinical Programs

Eight of Eight Patients Successfully Transitioned from Oral Tacrolimus to TFF TAC with No Sign of Acute Rejection at Reduced Systemic Exposures

Data from TFF VORI Phase 2 and EAP Program Continue to Demonstrate Antifungal Activity and a Favorable Safety and Tolerability Profile

TFF TAC Program Prioritized Based on Positive Phase 2 Data, the Potential to Address a Significant Unmet Need in Lung Transplant Medicine and Substantial Market Opportunity

Company to Hold Conference Call and Webcast Today at 4:30 pm ET

FORT WORTH, TX – Mar 27, 2024 – TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced updated data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs.

Today’s updated data provide further promising evidence in support of the continued development of both TFF TAC and TFF VORI, with the interim clinical data suggesting that each product can be delivered safely and efficaciously into the lungs,” said Harlan Weisman, M.D., President and Chief Executive Officer of TFF Pharmaceuticals. “Based on the totality of these clinical data, we believe TFF TAC and TFF VORI have the potential to establish a new and significantly improved form of delivery for these two life-saving medicines. Initial data from these two programs demonstrate that Thin Film Freezing can generate inhalational products from approved medicines to improve efficacy through direct-to-lung delivery while decreasing systemic exposures and toxicities, with what we believe could become a best-in-class pulmonary drug delivery technology.

TFF TAC and TFF VORI Clinical Data Updates

Today, the Company is presenting new data from the ongoing Phase 2 study of TFF TAC for the prevention of acute rejection in lung transplant, and from the Phase 2 study and the Expanded Access Program (EAP) of TFF VORI for the treatment of invasive pulmonary aspergillosis (IPA). The updated safety and efficacy data are based on the cutoff date of March 8, 2024.

TFF TAC – updated Phase 2 data

The ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity. Part A of the trial is a 12-week treatment period, and Part B is an optional safety extension period. Trial endpoints include safety, tolerability, kidney function, and acute allograft rejection.

In December, the Company announced initial data from the first four patients enrolled in the trial. Today, the Company is presenting data from another four patients in the trial (N=8).

Updated Efficacy

● Successful transition eight of eight patients from oral Tacrolimus to TFF TAC

● No evidence of acute rejection:

o No signs and symptoms suggestive of acute rejection

o No use of pulse corticosteroids to treat acute rejection

o No deterioration in spirometry

o No chest x-ray findings suggestive of acute rejection

● 4/4 patients who completed Part A chose to remain on TFF TAC and proceeded to Part B.

Biomarker data will be disclosed at a Late Breaking Clinical Science abstract session at 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting on April 13, 2024. Professor Gregory Snell, the lead Principal Investigator of the TFF TAC Phase 2 study, will deliver the oral presentation.

Updated Safety

● No mortality

● No TFF TAC discontinuation due to an AE

● Majority of TEAEs were Grade 2 or lower in severity

● Maintenance of kidney function

On March 20, 2024, the Company announced prioritization of the TFF TAC program based on positive data from the ongoing Phase 2 study, the potential of the product to address a significant unmet need in lung transplant medicine, and the substantial market opportunity.

TFF VORI – updated Phase 2 and EAP data

The Phase 2 trial of TFF VORI enrolled patients with IPA and evaluated TFF VORI versus oral voriconazole in a 3:1 randomization after 13 weeks of treatment in an open label study. The trial endpoints included safety and tolerability, clinical, radiologic and mycologic responses, as well as all-cause mortality.

In December 2023, the Company presented initial safety data from a total of seven patients treated with TFF VORI – three from the Phase 2 study and four from the EAP. Of these seven patients, five had completed at least eight weeks of TFF VORI therapy and were therefore also eligible for assessment of treatment response. The Company found the initial data from TFF VORI to be directionally informative, and given the availability of considerable historical and real-world data on safety, tolerability and efficacy for oral voriconazole, sufficient to move towards Phase 3 development. Therefore, enrollment in the Phase 2 study was stopped to focus resources on next steps for the program. The Expanded Access Program is still open and is continuing to enroll patients.

As of March 8, 2024, two additional patients have enrolled in the EAP, bringing the total number of patients receiving TFF VORI up to nine. Today, the Company now has follow-up safety data on one of the two new EAP patients and is therefore providing updated safety data for eight patients. With respect to efficacy, one additional patient from the Phase 2 study completed TFF VORI therapy and therefore became available for treatment response bringing the total number of patients for assessment of efficacy to six.

2

Updated Efficacy

● Five of six patients achieved a clinical response with TFF VORI, which we define as improvements in signs, symptoms and/or spirometry

● Five of six patients achieved a mycologic response, meaning no evidence of fungal infection on follow up assessment

● Three of four patients, who had an abnormal chest CT at baseline and also had a follow up chest CT, achieved a radiologic response, meaning improvement in radiologic findings attributable to their fungal infection.

● No need for continued anti-fungal use after treatment with TFF VORI in all six patients.

Updated Safety

● TFF VORI continues to maintain an attractive safety profile:

o No IPA-related mortality.

o No all-cause mortality

§ One TFF VORI discontinuation due to an unrelated adverse event of COVID infection that required intubation.

§ Majority of treatment-related adverse events (TEAEs) were deemed unrelated to TFF VORI

§ Majority of TEAEs were Grade 2 or lower in severity.

§ No hepatic toxicity

§ No visual disturbances.

On March 20, 2024, the Company announced its decision to explore strategic alternatives, including partnering opportunities, collaborations, and government-based funding sources to support the continued development of TFF VORI.

Conference Call and Webcast Information

The Company will host a conference call today at 4:30 pm Eastern Time, to discuss updated data for the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs. To participate in the conference call, please utilize the following information:

Domestic Dial-In Number: Toll-Free: 1-888-886-7786

International Dial-In Number: 1-416-764-8658

Conference ID: 24531709

Call me™: LINK (will be made active 15 minutes prior to the scheduled start time)

The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals’ Website, https://tffpharma.com or directly athttps://viavid.webcasts.com/starthere.jsp?ei=1658279&tp_key=8445c4138a

The conference call will also be available for replay for one month on the Company's website in the Events Calendar of the Investors section.

ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY

TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.

3

ABOUT TFF PHARMACEUTICALS

TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile TFF technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, or for topical delivery to the eyes, nose and the skin. TFF Pharmaceuticals has two lead drug candidates in the clinic: TFF TAC (Tacrolimus Inhalation Powder) and TFF VORI (Voriconazole Inhalation Powder). The Company continues collaborations with a broad array of pharmaceutical companies, academic institutions, and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by over 170 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 advancement of TFF TAC and TFF VORI into potentially registration-enabling studies; the expectation that the initial data readouts for TFF TAC and TFF VORI will be consistent with the further data from the ongoing Phase 2 clinical trials and related EAP; and the benefits of the Company’s TFF platform. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the further data from the ongoing Phase 2 clinical trials and related EAP for TFF TAC and TFF VORI will not be favorably consistent with the initial data initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for TFF TAC and TFF VORI candidates, (iii) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vi) the risk that the Company may not be able to obtain additional working capital with which to continue the Phase 2 clinical trials and related EAP, or advance to the initiation of registration-enabling studies, for TFF TAC and TFF VORI as and when needed and (vii) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 14, 2023. 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.

Investor Relations Contact:

Corey Davis, Ph.D.

LifeSci Advisors

(212) 915-2577

cdavis@lifesciadvisors.com

4

EX-99.2

Exhibit 99.2

1 NASDAQ: TFFP TFF TAC and TFF VORI Program Update March 27, 2024 – 4:30 PM EDT BETTER DELIVERY, BETTER THERAPY | Powerful Drug Delivery Solutions

2 Safe Harbor Statement SPECIAL NOTE REGARDING FORWARD - LOOKING STATEMENTS This document contains forward - looking statements concerning TFF Pharmaceuticals, Inc. (“TFF”, “TFF Pharmaceuticals”, the “Compa ny,” “we,” “us,” and “our”). The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “ pla n,” “expect” and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward - looking statements. These forward - looking statements i nclude, but are not limited to, statements concerning the following: the benefits of our TFF platform; advancement of TFF TAC and TFF VORI into potentially registration - enabling studies; TFF TAC’s and TFF VORI’s substantial market opportunity; the expectation that the further data from the ongoing Phase 2 clinical trial for TFF TAC and TFF VORI will be consistent wit h the data readouts for each product candidate to date; and our exploration of strategic alternatives for TFF VORI, including partnering opportunities, collaborations, and government - based funding sources. Those forward - looking statements involve known and unknown risks, uncertainties and other factors that could cause actual result s to differ materially. Among those factors are: ( i ) the risk that the further data from the ongoing Phase 2 clinical trials for TFF TAC and TFF VORI will not be favorably cons ist ent with the initial data readouts, (ii) the risk that we may not be able to advance to registration - enabling studies for TFF TAC, (iii) the risk we may not be successful in our pursuit of strategic alternatives for TFF VORI; (iv) success in early phases of pre - clinical and clinicals trials do not ensure later clinical trials will be successful; (v) no drug product incorporating the TFF platform has received FDA pre - market approval or otherwise been incorporated into a commercial drug product, (vi) the Company has no curr ent agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF platform, (vii) the risk that the Company may not be able to obtain additional working capital with which to continue the Phase 2 clinical trials and or advance to the initiation of registratio n - e nabling studies, for TFF TAC as and when needed and (viii) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10 - Q filed with the SEC on November 14, 2023 and subsequently filed reports. 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 eve nts 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 informat ion you should consider before investing. Please refer to our reports and registration statements on file with the SEC for more comprehensive information concerning TF F P harmaceuticals. 2

3 NASDAQ: TFFP BETTER DELIVERY, BETTER THERAPY | Powerful Drug Delivery Solutions Harlan Weisman, M.D., Chief Executive Officer Opening Remarks

4 4 TFF TAC Clinical Data Update: Phase 2

5 5 TFF TAC: Addressing Significant Unmet Need in Lung Transplant Rejection TFF TAC is in Phase 2 development for prevention of rejection in lung transplant recipients • Tacrolimus is first - line calcineurin inhibitor for prevention of rejection in lung transplant • Significant toxicities associated with oral tacrolimus • TFF TAC delivers tacrolimus directly to the lung to drive efficacy through immune suppression locally in the lung, where infl amm ation leads to rejection and allograft failure, while limiting systemic exposure thus systemic toxicities • High unmet medical need with ~50% mortality in 5 years 1 due to narrow therapeutic index: • Too little immune suppression leads to acute rejection or chronic rejection leading to chronic lung allograft dysfunction (CL AD) • Too much immune suppression leads to infections, chronic kidney disease, and post transplant lymphoproliferative disease ~40,000 new and existing patients worldwide 2 ൒ $2 billion peak TFF TAC global gross sales forecast 3 1. Costa, Benvenuto, and Sonett , Best Practice & Research Clinical Anesthesiology , 2017 2. UpToDate; OPTN, UNOS, and Transplant Literature 3. Internal estimates TFF TAC is intended to i ncrease lung delivery to drive efficacy while minimizing systemic exposures and toxicities

6 TFF TAC: Phase 2 Trial Design in Lung Transplant Patients • Design : Open label study of TFF TAC in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity • Duration : Part A: 12 weeks; Part B: optional safety extension • Endpoints : Safety and tolerability, kidney function, acute allograft rejection Screening Day 1 2 weeks Week 12 Treatment Optional open - label extension • Bronchoscopy and biopsy • Spirometry • Donor - derived cell - free DNA assay • Lung imaging Therapeutic drug monitoring Dose adjustment Safety and tolerability Renal function Clinical signs of acute rejection Lung imaging (Week 4) TFF TAC (Tacrolimus Inhalation Powder) • Bronchoscopy and biopsy • Spirometry • Donor - derived cell - free DNA assay • Lung imaging

7 TFF TAC: Baseline Characteristics and Demographics 7 CLAD: chronic lung allograft dysfunction W: white ; F: female; M: male; NH: Native Hawaiian N/A: not available Data is from TFF - T2 - 001 pre - database lock; Data cut off date: 3/25/24 Disposition Time on TFF Tac (weeks) Years with kidney disease CLAD Years since transplant Race Sex Age (years) Patient Chose to proceed to Part B 49.0 5 No 9 W M 73 Pt 1 Chose to proceed to Part B 40.0 6 No 8 W F 73 Pt 2 Chose to proceed to Part B 33.0 4 No 5 W M 68 Pt 3 Chose to proceed to Part B 20.0 2.5 No 3 W F 67 Pt 4 11.9 2.5 No 3 W M 64 Pt 5 9.0 7 No 23 W F 52 Pt 6 5.9 NA No 0.75 W F 41 Pt 7 5.0 NA No 1.25 NH M 56 Pt 8

8 TFF TAC: Total Patient Exposure Data is from TFF - T2 - 001 pre - database lock; Data cut off date: 3/25/24 0 20 40 60 80 100 120 140 160 180 200 Weeks Pt 8 Pt 7 Pt 6 Pt 5 Pt 4 Pt 3 Pt 2 Pt 1 Cumulative Total patient exposure represents ~1200 days, ~3.3 years

9 9 Suitability For Dry Powder Inhalers Stable Trough Tacrolimus Blood Levels: TFF TAC / Oral Tacrolimus Mean Stable TFF TAC Dose / Mean Stable oral Tacrolimus Dose ~2/3 (~66%) ~1/6 (~17%) Data is from TFF - T2 - 001 pre - database lock; Data cut off date: 3/8/24 n=8 • Successful transition of 8/8 patients from oral Tacrolimus to TFF TAC • No evidence of acute rejection • No signs and symptoms suggestive of acute rejection • No use of pulse corticosteroids for treatment of rejection • No spirometry deterioration suggestive of acute rejection • No chest x - ray findings suggestive of acute rejection • B iomarker data to be disclosed • 4/4 patients who completed Part A chose to remain on TFF TAC and proceeded to Part B Efficacy Safety • No mortality • No TFF TAC discontinuation due to an AE • Majority of TEAEs were Grade 2 or lower in severity • Maintenance of kidney function Key Takeaways • Interim clinical data suggest: • Lower doses of TFF TAC compared to oral Tacrolimus are sufficient to prevent rejection. • TFF TAC prevents rejection at reduced systemic Tacrolimus blood levels, thus lowering the risk of systemic toxicity. TFF TAC: Data suggest TFF TAC prevents rejection at reduced systemic exposure

10 Regulatory: • FDA endorsed the 505(b)2 pathway for TFF TAC development • FDA granted orphan drug designation • Open the IND in the US: S ummer of 2024 • Apply for FDA expedited programs Phase 3: • Endeavor to seamlessly transition Phase 2 study in the US to a global Phase 3 study • A single Phase 3 study is expected to be sufficient for registration • Expected t otal sample size: approximately 200 • US, Canada, Australia, UK, and select EU countries 2024 milestones: • Advisory board meeting held in 2/2024; feedback from advisors incorporated into development plan • ISHLT late breaking abstract oral presentation in Prague in 2Q2024 • Additional data update on the Phase 2 Australian study in 3Q2024 • Open IND in the US to initiate phase 2 US trial ISHLT: International Society of Heart and Lung Transplantation TFF TAC: Next Steps

11 11 TFF VORI Clinical Data Update: Phase 2 and Expanded Access Program

12 1. Voriconazole Package Insert; Warning and Precautions section, 5.2 and 5.3 2. Maertens et. al. Lancet 2016; 387:760 - 769. 3. Bongomin et. al. Journal of Fungi. 2017 4. Internal estimates. Assumes indication for acute treatment of IPA • IPA primarily impacts immune compromised patients (hematologic malignancies, solid organ, and stem cell transplant recipients ) • Oral and intravenous voriconazole is first - line therapy for the treatment of IPA • Narrow therapeutic window associated with oral and IV voriconazole Significant toxicities ▪ Liver toxicity, arrhythmias and QT prolongation, infusion related reactions, visual disturbances, severe cutaneous adverse reactions, photosensitivity and renal toxicity 1 Drug - drug interactions • High unmet medical need with ~30% mortality in 12 weeks 2 due to high rate of toxicity and drug - drug interactions limiting systemic dosing and overall efficacy TFF VORI is in Phase 2 development for the treatment of pulmonary fungal infections including invasive pulmonary aspergillosis (IPA) TFF VORI: Addressing Significant Unmet Need in Pulmonary Fungal Infections 12 TFF VORI is intended to increase lung delivery to drive efficacy while minimizing systemic exposures, toxicities, and drug - drug interactions ~250,000 invasive aspergillosis (IA) patients worldwide 3 ൒ $1 billion peak TFF VORI global gross sales forecast 4

13 TFF VORI: Phase 2 Trial Design in Patients with Invasive Pulmonary Aspergillosis • Design : Open label randomized study; TFF VORI vs. oral voriconazole • Duration : 13 weeks of treatment • Endpoints : Safety/tolerability, clinical response, radiologic response, mycologic response, all - cause mortality R 3:1 Randomization TFF VORI (80mg twice daily Voriconazole Inhalation Powder) Oral Voriconazole (200mg twice daily Vfend ) Weeks 1 - 2 Weeks 4 - 8 Weeks 8 - 13 Screening • Mycologic tests • Galactomannan • Lung Imaging • Spirometry Weeks 2 - 4 Weeks 13 - 17 2 weeks Dosing Follow - up Galactomannan Spirometry Galactomannan Spirometry Spirometry • Mycologic tests • Galactomannan • Lung Imaging • Spirometry Spirometry Clinical assessment throughout; bronchoscopy optional at any time; pharmacokinetics, all - cause mortality • Mycologic tests • Galactomannan • Spirometry • Lung imaging Spirometry

14 • The Expanded Access Program (EAP) enrolls patients with the following diagnoses who have limited or no other treatment options or who have had an unfavorable response to adequate standard of care therapy: Pulmonary aspergillosis: ▪ Invasive pulmonary aspergillosis (IPA) ▪ Chronic pulmonary aspergillosis (CPA) ▪ Allergic bronchopulmonary aspergillosis (ABPA) ▪ Aspergillus tracheobronchitis ▪ Aspergillus bronchoanastomotic infection Voriconazole responsive pulmonary fungal infections • US expanded access protocol prepared and submitted to the FDA: https://clinicaltrials.gov/ct2/show/NCT05897294 • Available in the US, Canada, Australia, UK, and select EU countries TFF VORI: Expanded Access Program (EAP) 14

15 15 Suitability For Dry Powder Inhalers Data is from pre - database lock TEAE: treatment emergent adverse event • Of the six patients treated for at least 12 weeks with TFF VORI: • Five patients achieved a clinical response (improvement in signs, symptoms and/or spirometry) • Five patients achieved a mycologic response (presumed or proven) • Three of four patients achieved a radiologic response (4 patients with abnormal baseline and follow up chest CT) • No need for continued anti - fungal use after treatment with TFF VORI in all six patients • Of the 8 patients treated with TFF VORI for any length of time with follow - up data: No IPA - related mortality No all - cause mortality One TFF VORI discontinuation due to an unrelated AE (COVID) Majority of TEAEs deemed unrelated to TFF VORI Majority of TEAEs were Grade 2 or lower in severity No hepatic toxicity No visual disturbances Efficacy TFF VORI: Summary of Results IPA is a pulmonary fungal infection with ~30% mortality in 12 weeks Safety

16 Regulatory: • IND is open in the US • 505(b)2 pathway endorsed by the FDA Strategic Plan: • Explore partnerships, collaborations, and grants to progress the program Phase 3 Development: • A single Phase 3 study is expected to be sufficient for registration • Potential indications: • Treatment or prevention of IPA and other voriconazole responsive invasive pulmonary fungal infections • Treatment of chronic pulmonary aspergillosis, allergic bronchopulmonary aspergillosis, aspergillus tracheobronchitis and aspergillus bronchoanastomotic infection • Treatment or prevention of Valley Fever (coccidioidomycosis) and other endemic fungal infections 2024 milestones: • Secure p artnerships , collaborations and grants to advance clinical development Minimal spending on TFF VORI development until partnered TFF VORI: Next Steps

17 NASDAQ: TFFP TFF TAC and TFF VORI Program Update March 27, 2024 – 4:30 PM EDT BETTER DELIVERY, BETTER THERAPY | Powerful Drug Delivery Solutions

XML

Cover	Mar. 27, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 27, 2024
Entity File Number	001-39102
Entity Registrant Name	TFF PHARMACEUTICALS, INC.
Entity Central Index Key	0001733413
Entity Tax Identification Number	82-4344737
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	1751 River Run
Entity Address, Address Line Two	Suite 400
Entity Address, City or Town	Fort Worth
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	76107
City Area Code	817
Local Phone Number	438-6168
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock: Par value $.001
Trading Symbol	TFFP
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false