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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): December 15, 2023
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
5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
On
December 18, 2023, TFF Pharmaceuticals, Inc. (the
“Company”) filed with the Delaware Secretary of State a Certificate of Amendment (“Amendment”) to its Second
Amended and Restated Certificate of Incorporation to effect a one for twenty-five (25) reverse stock split (“Reverse
Split”) of its issued and outstanding shares of common stock. The effective time of the Reverse Split is 12:01 AM ET on
December 19, 2023. The Amendment has been filed as Exhibit 3.1 to this report.
On
December 15, 2023, the Company issued a press release concerning the Reverse Split. The press release is filed as Exhibit 99.1 to this
report.
Item
8.01 Other Events.
The
Company has scheduled a webcast for December 19, 2023 at which it will discuss interim data readouts for its ongoing Phase 2 clinical
trials of TFF VORI and TFF TAC. A copy of the presentation to be published via the webcast, and subsequently posted to the Company’s
website, is attached hereto as Exhibit 99.2. On December 19, 2023, the Company issued a press release summarizing the interim data readouts
for TFF VORI and TFF TAC. A copy of the press release is attached hereto as Exhibit 99.3
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
The
following exhibits are filed with this report:
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:
December 19, 2023 |
/s/
Kirk Coleman |
| |
Kirk
Coleman, |
| |
Chief
Financial Officer |
2
Exhibit
3.1
The
First State
I,
JEFFREY W. BULLOCK, SECRETARY OF STATE OF THE STATE OF DELAWARE, DO HEREBY CERTIFY THE ATTACHED IS A TRUE AND CORRECT COPY OF THE CERTIFICATE
OF AMENDMENT OF “TFF PHARMACEUTICALS, INC.”, FILED IN THIS OFFICE ON THE EIGHTEENTH DAY OF DECEMBER, A.D. 2023, AT 2:39 O’CLOCK
P.M.
AND
I DO HEREBY FURTHER CERTIFY THAT THE EFFECTIVE DATE OF THE AFORESAID CERTIFICATE OF AMENDMENT IS THE NINETEENTH DAY OF DECEMBER, A.D.
2023 AT 12:01 O’CLOCK A.M.
| |
|
 |
| 6725367 8100 |
 |
Authentication:
204843973 |
| SR# 20234256926 |
|
Date:
12-18-23 |
You
may verify this certificate online at corp.delaware.gov/authver.shtml
| State
of Delaware |
|
|
| Secretary
of State |
|
|
| Division
of Corporations |
|
|
| Delivered
02:39PM 12/18/2023 |
|
|
| FILED
02:39 PM 12/18/2023 |
|
|
| SR
20234256926 - File Number 6725367 |
|
|
CERTIFICATE
OF AMENDMENT
OF
SECOND
AMENDED AND RESTATED
CERTIFICATE
OF INCORPORATION
OF
TFF
PHARMACEUTICALS, INC.
TFF
Pharmaceuticals, Inc., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware
(the “Corporation”), does hereby certify:
1.
That the certificate of incorporation of the Corporation is hereby amended by inserting the following at the end of Article FOURTH
thereof:
“Upon
the effectiveness (the “Effective Time”) of the Certificate of Amendment inserting this paragraph in the Certificate of Incorporation,
each two (2) to thirty (30) that are issued and outstanding immediately prior to the Effective Time shall be reclassified and combined
into one (l) share of Common Stock, with the exact ratio to be determined by the Board prior to the Effective Time and publicly announced
by the Corporation, subject to the treatment of fractional share interests as described below (the “Reverse Split”). The Reverse
Split shall occur automatically without any further action by the Corporation or its stockholders and whether or not any certificate
representing such shares immediately prior to the Effective Time (an “Old Certificate”) is surrendered to the Corporation.
No fractional shares of Common Stock will be issued in connection with the Reverse Split. Stockholders of record who otherwise would
be entitled to receive fractional shares, will be entitled to receive cash (without interest) in lieu of fractional shares, equal to
such fraction multiplied by the average of the closing sales prices of the Common Stock on the exchange the Corporation is currently
trading during regular trading hours for the five consecutive trading days immediately preceding the effective date of the Reverse Split
(with such average closing sales prices being adjusted to give effect to the Reverse Split). Following the Effective Time, each Old Certificate
shall thereafter represent that number of shares of Common Stock into which the shares of Common Stock represented by the Old Certificate
shall have been reclassified and combined, subject to the elimination of fractional share interests as described above, until such time
as such Old Certificate has been surrendered to the Corporation.”
2.
That this amendment was duly adopted in accordance with Section 242 of the General Corporation Law of the State of Delaware.
3.
That, on December 8, 2023, the Board of Directors of the Corporation determined that each twenty-five (25) shares of the Corporation’s
common stock (the “Common Stock”), issued and outstanding immediately prior to the Effective Time, shall automatically be reclassified
and combined into one (1) validly issued, fully paid and non-assessable share of Common Stock, pursuant to the amendment set forth in
this Certificate of Amendment. The Corporation publicly announced this ratio on December 15, 2023.
4.
That this Certificate of Amendment shall become effective at 12:01 a.m. Eastern Time on December 19, 2023.
IN
WITNESS WHEREOF, TFF Pharmaceuticals, Inc. has caused this Certificate of Amendment to be signed by its authorized officer, as of
December 18, 2023.
| |
TFF PHARMACEUTICALS, INC. |
| |
|
|
| |
By: |
/s/ Kirk
Coleman |
| |
|
Kirk Coleman |
| |
|
Secretary and Chief Financial Officer |
Exhibit 99.1
TFF Pharmaceuticals Announces
Reverse Stock Split
Common Stock Will Begin Trading on a Split-Adjusted
Basis on December 19, 2023
FORT WORTH, Texas, December
15, 2023 -- 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 announced that it intends
to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 25 pre-split shares. The reverse stock
split will become effective at 12:01 A.M. Eastern Time, on December 19, 2023. The Company's common stock will continue to be traded on
the Nasdaq Capital Market under the symbol “TFFP” and will begin trading on a split-adjusted basis when the market opens on December
19, 2023.
At a special meeting
of stockholders held on November 21, 2023, the Company's stockholders granted the Company's Board of Directors the discretion to effect
a reverse stock split of the Company's common stock through an amendment to its Second Amended and Restated Certificate of Incorporation,
as amended, at a ratio of not less than 1-for-2 and not more than 1-for-30, with such ratio to be determined by the Company's Board of
Directors.
At the effective time
of the reverse stock split, every 25 shares of the Company's issued common stock will be converted automatically into one issued share
of common stock without any change in the par value per share. Stockholders holding shares through a brokerage account will have their
shares automatically adjusted to reflect the 1-for-25 reverse stock split. It is not necessary for stockholders holding shares of the
Company's common stock in certificated form to exchange their existing stock certificates for new stock certificates of the Company in
connection with the reverse stock split, although stockholders may do so if they wish.
The reverse stock split
will affect all stockholders uniformly and will not alter any stockholder's percentage interest in the Company's equity, except to the
extent that the reverse stock split would result in a stockholder owning a fractional share. No fractional shares of common stock will
be issued in connection with the reverse split. Stockholders of record who otherwise would be entitled to receive fractional shares, will
be entitled to receive cash (without interest) in lieu of fractional shares, equal to such fraction multiplied by the average of the closing
sales prices of the common stock on the Nasdaq Capital Market during regular trading hours for the five consecutive trading days immediately
preceding the effective date of the reverse split (with such average closing sales prices being adjusted to give effect to the reverse
split).
The reverse stock split
will reduce the number of issued shares of the Company's common stock from 59,133,574 shares to approximately 2,365,343 shares. Proportional
adjustments will be made to the number of shares of the Company's common stock issuable upon exercise or conversion of the Company’s
equity awards and warrants, as well as the applicable exercise price. Stockholders whose shares are held in brokerage accounts should
direct any questions concerning the reverse stock split to their broker. All stockholders of record may direct questions to the Company's
transfer agent, Pacific Stock Transfer Company, at 702-361-3033.
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.
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 VORI (Voriconazole Inhalation Powder) and TFF TAC (Tacrolimus 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, plans for releasing initial clinical data by the end of 2023 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 Company’s preclinical and IND enabling
studies of the dry powder formulation of its product candidates may not be successful, (ii) no drug product incorporating the TFF platform
has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iii) 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 (iv)
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
Exhibit 99.2
1 NASDAQ: TFFP BETTER DELIVERY, BETTER THERAPY | Powerful Drug Delivery Solutions TFF VORI and TFF TAC: Presentation of Initial Phase 2 Data December 19, 2023
Safe Harbor Statement SPECIAL NOTE REGARDING FORWARD - LOOKING STATEMENTS This document contains forward - looking statements concerning TFF Pharmaceuticals, Inc. (“TFF”, “TFF Pharmaceuticals”, 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: the expected reception of the initial data readouts for TFF VORI and TFF TAC and the ability of such data to support a decision to move to Phase 3 clinical trials for either TFF VORI or TFF TAC; the expectation that the initial data readouts for TFF VORI and TFF TAC will be consistent with the final data from the completed Phase 2 clinical trials and related Expanded Access Programs for TFF VORI and TFF TAC; the success of our clinical trials; 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) the risk that the final data from the completed Phase 2 clinical trials and related Expanded Access Programs for TFF VORI and TFF TAC will not be consistent with the initial data initial data readouts for TFF VORI and TFF TA, (ii) the risk that the Company may not be able to successfully conclude clinical testing of TFF VORI, TFF TAC or any of its other dry powder product candidates, (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) success in early phases of pre - clinical and clinicals trials do not ensure later clinical trials will be successful, (vi) the risk that the Company may not be able to obtain additional working capital 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. 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. 2
3 NASDAQ: TFFP BETTER DELIVERY, BETTER THERAPY | Powerful Drug Delivery Solutions Harlan Weisman, M.D., Chief Executive Officer Opening Remarks December 19, 2023
4 TFF VORI Initial Data: Phase 2 and Expanded Access Program
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 TFF VORI: Addressing Significant Unmet Need in Pulmonary Fungal Infections 5 Increase lung delivery to drive efficacy while minimizing systemic exposures, toxicities, and drug - drug interactions TFF VORI is in Phase 2 development for the treatment of pulmonary fungal infections including invasive pulmonary aspergillosis (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 ~250,000 invasive aspergillosis (IA) patients worldwide 3 ≥ $1 billion peak TFF VORI global gross sales forecast 4
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 T F F V O R I (80mg twice daily Voriconazole Inhalation Powder) Oral Voriconazole (200mg twice daily Vfend) We e k s 1 - 2 We e k s 4 - 8 We e k s 8 - 13 Screening • Mycologic tests • Galactomannan • Lung Imaging • Spirometry We e k s 2 - 4 We e k s 13 - 17 2 w ee k s D o s i n g Follow - up Ga l a c t om a nna n Spirometry Spirometry Galactomannan Spirometry Spirometry • Mycologic tests • Galactomannan • Lung Imaging • Spirometry Clinical assessment throughout; bronchoscopy optional at any time; pharmacokinetics, all - cause mortality • Mycologic tests • Galactomannan • Spirometry • Lung imaging Spirometry 6
• 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) 7
Based on the highly encouraging results of the initial data readout , we plan to accelerate the development of TFF VORI into registration - enabling studies. The data readout includes: • Assessment of efficacy: Clinical response ▪ Improved signs and symptoms (heatmap with red representing more signs and symptoms) ▪ Stable or improved spirometry (FEV - 1=forced expiratory volume in one second) Mycologic response ▪ Lack of evidence of infection such as galactomannan (aspergillus biomarker), culture or PCR on follow up Radiologic response ▪ Improved radiologic findings such as number and/or size of nodules (high resolution chest CT) • Assessment of safety and tolerability All - cause mortality Treatment emergent adverse events including common, known voriconazole toxicities Treatment discontinuations Definition of success: TFF VORI is effective as an antifungal in majority of patients with a better overall safety and tolerability profile compared to oral or intravenous voriconazole TFF VORI: Initial Data Readout from Phase 2 and EAP 8
Efficacy • Of the five patients treated for at least 8 weeks with TFF VORI: • All five patients achieved a clinical response (improvement in signs, symptoms and/or spirometry) • All five patients achieved a mycologic response (presumed or proven ) • Three of four patients achieved a radiologic response (4 patients with baseline and follow up chest CT) • No need for continued anti - fungal use after treatment with TFF VORI in all five patients. Safety • No all - cause mortality • No IPA - related mortality • No TFF VORI discontinuation due to an AE • Majority of TEAEs deemed unrelated to TFF VORI • Majority of TEAEs were Grade 2 or lower in severity • No hepatic toxicity • No visual disturbances 9 TFF VORI: Summary of Results IPA a pulmonary fungal infection with ~30% mortality in 12 weeks Data is from pre - database lock; Data cut off date: 11/17/23; T E A E : t r e a t m e n t e m e r g e n t a dv e r s e eve n t
EAP: expanded access program; CLAD: chronic lung allograft dysfunction Data is from pre - database lock; Data cut off date: 11/17/23 TFF VORI: Baseline Characteristics and Demographics C o mpl e t ed t r e a tment? Last visit in the t r e a tment p eri o d CLAD Ho st f ac t o r Race Sex Age ( y e a rs) Patient/ t r e a tment Study/ p r o g r a m Yes 13 weeks N Lung transplant Asian F 45 Oral 1 P h a se 2 No* 4 weeks N Lung cancer W M 79 Oral 2 P h a se 2 Yes 13 weeks Y Lung transplant W F 58 T F F V ORI 1 P h a se 2 Ongoing 8 weeks N Lung transplant W M 51 T F F V ORI 2 P h a se 2 Ongoing 4 weeks N Lung transplant W M 69 T F F V ORI 3 P h a se 2 Yes 24 weeks Y Lung transplant W M 50 T F F V ORI 4 EAP Yes 12 weeks Y Lung transplant W F 54 T F F V ORI 5 EAP Yes 12 weeks N Lung transplant W F 59 T F F V ORI 6 EAP Ongoing Pending N Lung transplant W M 66 T F F V ORI 7 EAP W: white ; F: female; M: male Follow up data not available for patient TFF VORI 7 as of 11/17/23. 10 *Patient on oral voriconazole died at ~4 weeks. 5 TFF VORI patients with at least 8 weeks of treatment
Patients who completed at least 8 weeks of treatment TFF VORI: Efficacy Assessment 11 A ll - c a use m o r t a li t y C o mpl e t ed treatment CLAD R a d i o l o gi c response M y co l o gic response Clinical response T r e a tment duration Patient Im p r o v e d C T findings No evidence of infection Stable or improved sp i r om e tr y Improved signs and s y m pt o ms No Yes No x x x x 13 weeks Oral 1 No Yes Yes x x x x 13 weeks T F F V ORI 1 No No No x x x Pending 8+ weeks T F F V ORI 2 No Yes Yes x x x x 24 weeks T F F V ORI 4 No Yes Yes No x x x 12 weeks T F F V ORI 5 No Yes No Not assessed x x x 12 weeks T F F V ORI 6 Data is from pre - database lock; Data cut off date: 11/17/23
12 T o tal S ym p t o m S co r es Week 17 Week 13 Week 8 Week 4 Week 2 Week 1 D a y 1 Screening 1 0 6 5 5 6 2 2 Oral 1 All - cause mortality R a d i o l o gi c response Mycologic response Clinical response T r e a tment duration Patient Im p r o v e d C T findings No evidence of infection Stable or improved spirometry Im p r o v e d S ign s and Symptoms No x x x x 13 weeks Oral 1 20 0 40 60 80 100 S cre e n Da y 1 W k 1 W k 2 W k 4 W k 6 /8 Wk Wk 12/1 3 17/24 F EV - 1 % BAL: bronchoalveolar lavage 45 - yr - old female lung transplant recipient presented with moderate respiratory insufficiency and BAL evidence of Aspergillus TFF VORI: Patient Oral 1 (Phase 2) Follow up mycologic assessment: • Serum galactomannan and blood PCR n e g a t i v e Data is from pre - database lock; Data cut off date: 11/17/23
13 B a se li ne Week 13 Bronchial wall thickening/ obstruction with air trapping TFF VORI: Patient Oral 1 (Phase 2) Data is from pre - database lock; Data cut off date: 11/17/23
Data is from pre - database lock; Data cut off date: 11/17/23 14 T o tal s ym p t o m sco r e Week 13 Week 8 Week 4 Week 1 D a y 1 Screening 3 9 8 6 6 8 T FF V ORI 1 All - cause mortality R a d i o l o gi c response Mycologic response Clinical response T r e a tment duration Patient Im p r o v e d C T findings No evidence of infection Stable or improved spirometry Im p r o v e d s igns and symptoms No x x x x 13 weeks T F F V ORI 1 Unrelated SAEs: presumed bacterial respiratory infections 20 0 100 80 60 40 S cre e n Da y 1 Wk 1 Wk 2 Wk 4 Wk 6/8 Wk 12/13 F EV - 1 % BAL: bronchoalveolar lavage; SAE: serious adverse event 58 - year - old female lung transplant recipient with history of CLAD presented with mild fever and hemoptysis (coughing up blood) and moderate pleuritic chest pain, pleuritic rub and respiratory insufficiency and BAL evidence of Aspergillus TFF VORI: Patient TFF VORI 1 (Phase 2) Follow up mycologic assessment: • Serum galactomannan and blood PCR n e g a t i v e
B a se li ne Week 13 TFF VORI: Patient TFF VORI 1 (Phase 2) 15 Data is from pre - database lock; Data cut off date: 11/17/23 Aspergillus Nodules
All - cause mortality R a d i o l o gi c response Mycologic response Clinical response T r e a tment duration Patient Im p r o v e d C T findings No evidence of infection Stable or improved spirometry Im p r o v e d s igns and symptoms No x x x pending 8+ weeks T F F V ORI 2 T o t a l S y m pt o m S co r es W ee k 8 W ee k 4 W ee k 2 W ee k 1 Day 1 Screening 1 1 1 1 1 1 T F F V ORI 2 0 40 20 60 80 100 S cr e e n Da y 1 W k 1 W k 2 W k 4 W k 6 /8 F EV - 1 % BAL: bronchoalveolar lavage 51 - yr - old white male lung transplant recipient with mild respiratory insufficiency & BAL evidence of Aspergillus TFF VORI: Patient TFF VORI 2 (Phase 2) Follow up mycologic assessment: • Serum galactomannan and blood PCR 16 Data is from pre - database lock; Data cut off date: 11/17/23 n e g a t i v e
B a se li ne Week 8 TFF VORI: Patient TFF VORI 2 (Phase 2) 17 Data is from pre - database lock; Data cut off date: 11/17/23
18 All - cause mortality R a d i o l o gi c response Mycologic response Clinical response T r e a tment duration Patient Im p r o v e d C T findings No evidence of infection Stable or improved spirometry Im p r o v e d s igns and symptoms No x x x x 24 weeks T F F V ORI 4 T o t a l S y m pt o m S co r es Week 24 Screening 3 6 T F F V ORI 4 60 40 20 0 80 100 F EV - 1% BAL: bronchoalveolar lavage 50 - yr - old white male lung transplant recipient with CLAD presented with moderate cough, dyspnea (shortness of breath) and respiratory insufficiency and BAL evidence of Scedosporium, which is voriconazole sensitive, and Lomentospora TFF VORI: Patient TFF VORI 4 (EAP) Follow up mycologic assessment: • BAL culture for Scedosporium n e g a t i v e Data is from pre - database lock; Data cut off date: 11/17/23
19 B a se li ne ~Week 12 TFF VORI: Patient TFF VORI 4 (EAP) Data is from pre - database lock; Data cut off date: 11/17/23
TFF VORI: Patient TFF VORI 5 (EAP) 54 - yr - old white female lung transplant recipient and CLAD presented with moderate cough and dyspnea (shortness of breath) and BAL evidence of Aspergillus 20 All - cause mortality R a d i o l o gi c response Mycologic response Clinical response T r e a tment duration Patient Im p r o v e d C T findings No evidence of infection Stable or improved spirometry Im p r o v e d s igns and symptoms No No x x x 12 weeks T F F V ORI 5 T o t a l S y m pt o m S co r es Week 12/13 Screening 2 4 T F F V ORI 5 20 0 40 60 80 100 F EV - 1 % BAL: bronchoalveolar lavage n e g a t i v e Follow up mycologic assessment: • BAL culture and PCR for Aspergillus Despite recurrent episodes of IPA every 2 - 3 months previously, this patient has not had IPA in 1 year since completing treatment with TFF VORI Data is from pre - database lock; Data cut off date: 11/17/23
TFF VORI: Patient TFF VORI 6 (EAP) 59 - yr - old white female lung transplant recipient presented with mild cough and dyspnea (shortness of breath) and BAL evidence of Aspergillus All - cause mortality R a d i o l o gi c response Mycologic response Clinical response T r e a tment duration Patient Im p r o v e d C T findings No evidence of infection Stable or improved spirometry Im p r o v e d s igns and symptoms No Not assessed x x x 12 weeks T F F V ORI 6 T o t a l S y m pt o m S co r es Week 12/13 W ee k 8 Screening 1 1 2 T F F V ORI 6 20 0 40 60 80 100 S cre e n Da y 1 W k 1 W k 2 Wk 4 Wk 6/8 Wk 12/13 F EV - 1 % BAL: bronchoalveolar lavage n e g a t i v e 21 Data is from pre - database lock; Data cut off date: 11/17/23 Follow up mycologic assessment: • BAL culture, microscopy and galactomannan Follow up radiologic assessment: • Not performed • CT was not repeated
Patients who completed at least 8 weeks of treatment 22 Data is from pre - database lock; Data cut off date: 11/17/23 TFF VORI: Clinical Signs and Symptoms End of Treatment Screening 0 2 Oral 1 3 8 TFF VOR 1 pending 1 TFF VORI 2 3 6 TFF VORI 4 2 4 TFF VORI 5 1 2 TFF VORI 6 Total Symptom Score
Open circles indicate imputed numbers. 23 Data is from pre - database lock; Data cut off date: 11/17/23 0 20 40 60 80 1 0 0 Pr e S c r S c r een Da y 1 W k 1 W k 2 W k 4 W k 6 /8 W k 1 2 / 1 3 W k 1 7 / 24 FE V - 1 % Oral 1 T F F V O R I 1 T F F V O R I 2 T F F V O R I 4 T F F V O R I 5 T F F V O R I 6 Spirometry Patients who completed at least 8 weeks of treatment
Post - treatment mycologic evaluation (galactomannan/PCR) Baseline mycologic evidence (culture, microscopy and/or galactomannan) Patient Serum galactomannan & blood PCR Negative BAL positive Oral 1 Serum galactomannan & blood PCR Negative BAL positive T F F V ORI 1 Serum galactomannan & blood PCR Negative BAL positive T F F V ORI 2 BAL Negative BAL positive T F F V ORI 4 BAL Negative BAL positive T F F V ORI 5 BAL Negative BAL positive T F F V ORI 6 24 Data is from pre - database lock; Data cut off date: 11/17/23 BAL: bronchoalveolar lavage Patients who completed at least 8 weeks of treatment TFF VORI: Mycological Assessment
Post - treatment radiologic evaluation Baseline radiologic evidence Patient Resolved Bronchial wall thickening Oral 1 Resolved Nodules and bronchial wall thickening T F F V ORI 1 Resolved Nodules T F F V ORI 2 Resolved Nodules T F F V ORI 4 Not resolved Single pre - existing nodule T F F V ORI 5 Chest CT not repeated G r oun d - g l a ss o p aci t y T F F V ORI 6 Patients who completed at least 8 weeks of treatment TFF VORI: Radiologic Assessment Despite recurrent episodes of IPA every 2 - 3 months previously, patient TFF VORI 5 has not had IPA in 1 year since completing treatment with TFF VORI 25 Data is from pre - database lock; Data cut off date: 11/17/23
Patients who completed at least 8 weeks of treatment TFF VORI: Efficacy Assessment A ll - c a use m o r t a li t y C o mpl e t ed treatment CLAD R a d i o l o gi c response M y co l o gic response Clinical response T r e a tment duration Patient Im p r o v e d C T findings No evidence of infection Stable or improved sp i r om e tr y Improved signs and s y m pt o ms No Yes No x x x x 13 weeks Oral 1 No Yes Yes x x x x 13 weeks T F F V ORI 1 No No No x x x Pending 8+ weeks T F F V ORI 2 No Yes Yes x x x x 24 weeks T F F V ORI 4 No Yes Yes No x x x 12 weeks T F F V ORI 5 No Yes No Not assessed x x x 12 weeks T F F V ORI 6 26 Data is from pre - database lock; Data cut off date: 11/17/23
TFF V O R I ( n = 7) O ral ( n = 2) 14 13 Number of TEAEs 2 (29%) 2 (100%) Number of patients with any TEAEs 0 0 Number of related TEAEs 5 8 Number of possibly or probably related TEAEs 2 (29%) 1 (50%) Number of patients with possibly or probably related TEAEs 3 2 Number of Grade 3 and above TEAEs 1 (14%) 1 (50%) Number of patients with Grade 3 or above TEAEs 3 1 Number of SAEs 1 (14%) 1 (50%) Number of patients with SAEs 0 0 Number of related, possibly related or probably related SAEs 0 0 Number of TEAEs that occurred in more than 2 patients 0 1 (50%) Number of patients who experienced deaths 0 1 (50%) Number of patients who discontinued study treatment due to an AE 0 1 (50%) Number of patients with visual disturbance 0 1 (50%) Number of patients with Hepatic toxicity 27 Data is from pre - database lock; Data cut off date: 11/17/23 TEAE: treatment emergent adverse event; SAE: serious adverse event No bronchospasm No wheezing TFF VORI: Safety Data
TFF TAC Phase 2 Initial Results 28
Increase lung delivery to drive efficacy while minimizing systemic exposures, toxicities, and drug - drug interactions 29 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 and drug - drug interactions associated with oral tacrolimus • TFF TAC delivers tacrolimus directly to the lung to drive efficacy through immune suppression locally in the lung, where inflammation 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 (CLAD) Too much immune suppression leads to infections, chronic kidney disease, and post transplant lymphoproliferative disease ~40,000 new and existing patients worldwide 2 ≥ $1 billion peak TFF TAC global gross sales forecast 3 TFF TAC: Addressing Significant Unmet Need in Lung Transplant Rejection Data is from pre - database lock; Data cut off date: 11/17/23 1. Costa, Benvenuto, and Sonett, Best Practice & Research Clinical Anesthesiology , 2017 2. UpToDate; OPTN, UNOS, and Transplant Literature 3. Internal estimates
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 D a y 1 2 w ee k s W ee k 12 T r e a t m e n t 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) T F F T A C (Tacrolimus Inhalation Powder) • Bronchoscopy and biopsy • Spirometry • Donor - derived cell - free DNA assay • Lung imaging 30
TFF TAC: Initial Data Readout Definition of success: Transition patients from oral tacrolimus to TFF TAC, achieve tacrolimus blood levels that are approximately two - thirds to one - half of the patient's blood levels on oral tacrolimus, prevent rejection at these diminished tacrolimus blood levels while stabilizing kidney function 31 Based on the highly encouraging results of the initial data readout , we plan to accelerate the development of TFF TAC into registration - enabling studies. The data readout includes: • Assessment of efficacy: Signs and symptoms suggestive of acute rejection Need for pulse corticosteroids Deterioration in Spirometry Deterioration in lung imaging • Safety and tolerability Treatment emergent adverse events Treatment discontinuations Continuation to Part B, long term extension Kidney function
32 Efficacy • Successful transition of 4/4 patients from oral Tacrolimus to TFF TAC • Successful lowering of Tacrolimus blood levels No clinical evidence of acute rejection No signs and symptoms suggestive of acute rejection No use of pulse corticosteroids No deterioration in spirometry No chest x - ray findings suggestive of acute rejection • 3/3 patients who completed Part A chose to remain on TFF TAC and proceeded to Part B 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 TFF TAC: Summary of Results Data is from pre - database lock; Data cut off date: 11/29/23 T E A E : t r e a t m e n t e m e r g e n t a d ve r s e eve n t
TFF TAC: Baseline Characteristics and Demographics Disposition Last visit in the t r e a tment p eri o d Y e a rs w ith k i d n e y d ise a se CLAD Y e a rs sin c e transplant Race Sex Age Patient Chose to proceed to Part B Week 26 5 No 9 W M 73 Pt 1 Chose to proceed to Part B Day 86 6 No 8 W F 73 Pt 2 Chose to proceed to Part B Day 86 4 No 5 W M 68 Pt 3 Day 22 2.5 No 3 W F 67 Pt 4 33 Data is from pre - database lock; Data cut off date: 11/29/23 CLAD: chronic lung allograft dysfunction W: white ; F: female; M: male
Tacrolimus blood levels on T FF T A C ( ng / ml) S t a b le T FF T A C d o se Tacrolimus blood levels on oral Tacrolimus (ng/ml) Stable oral T ac r o limus d o se Patient 2.4 ~1/2 of oral level 0.75 mg ~1/7 of oral dose 5.6 5 mg Pt 1 2.6 2/3 of oral level 0.25 mg 1/4 of oral dose 3.9 1 mg Pt 2 2.2 ~1/2 of oral level 0.5 mg 1/11 of oral dose 4.6 5.5 mg Pt 3 1.9 ~1/2 of oral level 0.25 mg 1/8 of oral dose 4.5 2 mg Pt 4 Assessment of Allograft Rejection: • No clinical signs and symptoms suggestive of acute rejection • No deterioration in spirometry • No chest x - ray findings suggestive of acute rejection • No need for pulse corticosteroids • 3/3 patients who completed Part A chose to remain on TFF TAC and proceeded to Part B • Biomarker assessment of rejection is pending 34 Data is from pre - database lock; Data cut off date: 11/29/23 TFF TAC: Oral Tacrolimus to TFF TAC Dose Translation
Spirometry Data 35 Data is from pre - database lock; Data cut off date: 11/29/23
Kidney Function: Creatinine and GFR 10 0 20 30 40 60 50 - 2 4 W k s - 1 2 W k s S c ree n i n g D a y 1 D a y 8 D a y 15 D a y 22 D a y 29 D a y 57 D a y 85 Wk 26 e G F R Pt 1 Pt 2 Pt 3 Pt 4 50 0 100 150 250 200 - 24 Wks - 12 Wks Screening D a y 1 D a y 8 D a y 15 D a y 22 D a y 29 D a y 57 D a y 85 Wk 26 C r e a ti n i ne Pt 1 Pt 2 Pt 3 Pt 4 36 Data is from pre - database lock; Data cut off date: 11/29/23
37 TFF T A C ( n = 4) 14 Number of TEAEs 4 (100%) Number of patients with any TEAEs 0 Number of related TEAEs 9 Number of probably or possibly related TEAEs 2 (50%) Number of patients with possibly or probably related TEAEs 2 Number of Grade 3 and above TEAEs 1 (25%) Number of patients with Grade 3 or above TEAEs 1 Number of SAEs 1 (25%) Number of patients with SAEs 1 Number of possibly related SAEs 0 Number of TEAEs that occurred in more than 2 patients 0 Number of patients who experienced deaths 0 Number of patients who discontinued study treatment due to an AE 1 TEAE of worsening renal function* 1 T EAE of h a nd t r emo r ** No bronchospasm or wheezing reported TEAE: treatment emergent adverse event SAE: serious adverse event *Worsening renal function presumed from transient dehydration, unrelated to TFF TAC **Hand tremor resolved after dose reduction at Day 4 SAE of viral lower respiratory tract infection, expected in the setting of immune suppression TFF TAC: Safety Data Data is from pre - database lock; Data cut off date: 11/29/23
38 NASDAQ: TFFP BETTER DELIVERY, BETTER THERAPY | Powerful Drug Delivery Solutions THANK YOU
B a se li ne D a y 5 6 D a y 9 1 TFF VORI: Patient TFF VORI 1 (Phase 2) 39 Data is from pre - database lock; Data cut off date: 11/17/23 Ground glass opacities unrelated SAE N od u l e s
B a se li ne D a y 5 6 D a y 9 1 TFF VORI: Patient TFF VORI 1 (Phase 2) 40 Data is from pre - database lock; Data cut off date: 11/17/23 Ground glass opacities unrelated SAE N od u l e s
B a se li ne D a y 5 6 TFF VORI: Patient TFF VORI 2 (Phase 2) 41 Data is from pre - database lock; Data cut off date: 11/17/23
Total Symptom Scores 1 0 6 5 5 6 2 2 Oral 1 3 9 8 6 6 8 TFF VORI 1 1 1 1 1 1 1 TFF VORI 2 3 6 TFF VORI 4 2 4 TFF VORI 5 1 1 2 TFF VORI 6 Patients who completed at least 8 weeks of treatment TFF VORI: Clinical Signs and Symptoms • Far - left column represents signs and symptoms at screening • Far - right column represents signs and symptoms at the end of treatment • Patients enrolled in the Phase 2 study had more frequent assessments of signs and symptoms during treatment 42 Data is from pre - database lock; Data cut off date: 11/17/23
Exhibit 99.3
TFF Pharmaceuticals Announces Positive
Initial Data from Ongoing Phase 2 Trials of TFF VORI and TFF TAC
Treatment with TFF
VORI resulted in positive treatment outcomes based on clinical, mycologic and radiologic responses while maintaining a favorable safety/tolerability
profile, with no all-cause mortality, no invasive pulmonary aspergillosis (IPA)-related mortality, and no TFF VORI discontinuations due
to an adverse event (AE)
Successful transition
of all four patients from oral tacrolimus to TFF TAC, leading to significant lowering of tacrolimus blood levels with no clinical evidence
of acute rejection; all patients who completed Part A (study treatment period) of the trial chose to remain on TFF TAC and advance to
Part B (extension study)
TFF TAC was well tolerated,
with no mortality and no TFF TAC discontinuations due to an AE; kidney function was maintained in all patients treated with TFF TAC
Based on the promising
Phase 2 data for both products, the Company plans to accelerate the initiation of registration-enabling studies
Company to hold conference
call and webcast this morning at 8:30 am ET to review data
FORT WORTH, Texas, Dec. 19, 2023
-- 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 announced positive initial data from
the Company’s ongoing Phase 2 trials of TFF VORI and TFF TAC, along with clinical data from the ongoing TFF VORI Expanded Access
Program (EAP).
“Today is truly a remarkable moment
in the history of TFF Pharmaceuticals, as these initial clinical data clearly demonstrate the efficacy and favorable safety and tolerability
of TFF VORI and TFF TAC in two rare disease indications with high unmet medical need. These compelling results also demonstrate the successful
clinical application of our ground-breaking technology platform,” said Harlan Weisman, M.D., President and Chief Executive Officer
of TFF Pharmaceuticals. “Based on these highly encouraging efficacy and safety data, we have made the decision to accelerate the
development of TFF VORI and TFF TAC into registration-enabling studies, given the unequivocally positive results from these initial data.
Looking ahead, we expect to present additional clinical data in the first quarter of 2024 to further support the advancement of TFF VORI
and TFF TAC into registration-enabling studies.”
“These initial data provide compelling
evidence that both TFF VORI and TFF TAC have game-changing potential in the treatment of their respective rare disease indication, IPA
and prevention of rejection after lung transplantation,” said Zamaneh Mikhak, M.D., Chief Medical Officer of TFF Pharmaceuticals.
“With respect to TFF VORI, the initial data from the Phase 2 trial and our EAP clearly demonstrate a positively differentiated safety
and tolerability profile from the standard-of-care, first-line therapy, oral voriconazole, based on the available historical data. The
efficacy results are equally remarkable with treatment response seen in all patients. Initial results from the TFF TAC study are also
impressive. Patients treated with TFF TAC did not experience clinically acute rejection at significantly reduced blood tacrolimus levels.
Additionally, the patients maintained their kidney function and chose to remain on TFF TAC long term.”
TFF VORI - initial Phase 2 and EAP data
The ongoing Phase 2 trial of TFF VORI is an
open-label, randomized (3:1) study evaluating treatment with TFF VORI versus oral voriconazole over a 13-week period in patients with
IPA. Trial endpoints include safety, tolerability, clinical response, mycologic response, radiologic response, and all-cause mortality.
The initial efficacy data presented below include patients from the Phase 2 trial and the Company’s EAP who received at least 8
weeks of therapy with either TFF VORI (N=5) or oral voriconazole (N=1). Safety data included all TFF VORI-treated patients (N=7) and oral
voriconazole-treated patients (N=2). Of note, three of the five patients who were treated with TFF VORI for at least 8 weeks had a diagnosis
of chronic lung allograft dysfunction (CLAD), which is a lung disease caused by chronic rejection, from the immune system attacking the
transplanted lungs. CLAD is a significant cause of morbidity and mortality after lung transplantation and can be exacerbated by infections,
further deteriorating the patient’s condition. The patient treated with oral voriconazole for at least 8 weeks did not present with
CLAD.
Efficacy
| ● | Of the five patients treated for at least 8 weeks with TFF
VORI: |
| ● | All five patients achieved a clinical response |
| ● | All five patients achieved a mycologic response |
| ● | Three of four patients with pre- and post-treatment chest CT achieved a radiologic response |
| ● | No need for continued anti-fungal use after treatment with TFF VORI in all five patients |
Safety
| ● | No IPA-related mortality |
| ● | No TFF VORI discontinuation due to an AE |
| ● | Majority of treatment emergent adverse events (TEAEs) deemed unrelated to TFF VORI |
| ● | Majority of TEAEs were Grade 2 or lower in severity |
TFF TAC - initial 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. The initial data presented below are from the first four patients enrolled in the trial.
Efficacy
| ● | Of the four patients enrolled in the TFF TAC Phase 2 study: |
| ● | All four patients were successfully transitioned from oral tacrolimus to TFF TAC |
| ● | Successfully lowered tacrolimus blood levels to 1/2 to 2/3 of the levels on oral tacrolimus in all four patients |
| ● | No clinical evidence of acute rejection |
| ● | No signs and symptoms suggestive of acute rejection |
| ● | No use of pulse corticosteroids |
| ● | No deterioration in spirometry |
| ● | No chest X-ray findings suggestive of acute rejection |
| ● | All three patients who completed Part A chose to remain on TFF TAC and proceeded to Part B. |
Safety
| ● | No TFF TAC discontinuation due to an AE |
| ● | Majority of TEAEs were Grade 2 or lower in severity |
| ● | Maintenance of kidney function |
Conference Call and Webcast Information
The Company will host a conference call today,
Tuesday, December 19, 2023, at 8:30 AM Eastern Time, to discuss initial data from its ongoing Phase 2 trials of TFF VORI and TFF TAC.
To participate in the conference call, please utilize the following information:
Domestic Dial-In Number:
Toll-Free: 1-877-407-3982
International Dial-In
Number: 1-201-493-6780
Conference ID: 13743007
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 at https://viavid.webcasts.com/starthere.jsp?ei=1647021&tp_key=9bea30319a
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.
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 VORI (Voriconazole
Inhalation Powder) and TFF TAC (Tacrolimus 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 VORI and TFF TAC into potentially registration-enabling studies; the expectation
that the initial data readouts for TFF VORI and TFF TAC 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 VORI and TFF TAC 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 VORI and
TFF TAC 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 VORI and TFF TAC 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
Source: TFF Pharmaceuticals, Inc.
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