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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):
August 6, 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 August 6, 2024, the Company
issued a press release and published an investor presentation on its website at https://tffpharma.com/investors/. 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:
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: August 6, 2024 |
/s/ Kirk
Coleman |
| |
Kirk Coleman, |
| |
Chief Financial Officer |
2
Exhibit 99.1
TFF
Pharmaceuticals Provides Continued Positive Outcomes from Tacrolimus Inhalation Powder (TFF TAC)
Phase 2 Trial for the Prevention of
Lung Transplant Rejection
Patient enrollment has accelerated, now with
13 patients enrolled in trial
TFF TAC at ~20% of the oral tacrolimus dose
prevented acute rejection and achieved >80% of the previous oral trough blood levels -- leading to diminished drug burden
9 out of 9 (100%) patients who completed the
12-week treatment chose to remain on TFF TAC by proceeding to the long-term extension Phase; 2 patients have been treated for over a year
and 6 patients have been treated for more than 6 months
Observed a 6.5-fold reduction in the number
of abnormally expressed rejection-related gene sets after treatment with TFF TAC
No production of donor-specific antibodies (DSA)
after treatment with TFF TAC
FORT WORTH, TX – August 6, 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 provided an update from the Company’s
ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant rejection.
“The growing body of data from
the TFF TAC Phase 2 study continues to suggest that TFF TAC has transformative potential to advance the field of immunosuppressive therapy
to prevent lung transplant rejection,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “We are finalizing
the design of the next study with TFF TAC in close collaboration with our clinical investigators and in communication with regulatory
authorities and look forward to providing additional updates on the program including a regulatory update later in the fall.”
Clinical Trial Update
| ● | Patient
enrollment has accelerated with 13 patients now enrolled in Phase 2 trial |
| ● | TFF TAC at ~20% of the oral tacrolimus dose prevented acute rejection and achieved >80% of the
oral trough blood levels leading to diminished drug burden |
| ○ | No signs or 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 |
| ○ | No biomarker evidence of acute rejection (gene expression and donor-specific antibody) |
| ○ | Lower doses and no first pass effect to generate drug metabolites decreases drug burden with TFF
TAC compared with oral tacrolimus. |
| ● | 9 out of 9 (100%) patients who completed the 12-week treatment period with TFF TAC chose to remain
on the therapy by proceeding to the long-term extension phase; |
| ○ | 2 patients have been treated for over 1 year, and 6 patients have been treated for more than 6 months;
|
| ○ | Total patient exposure to TFF TAC therapy has now reached 2,063 days, or a total of 5.65 years. |
| ● | PK data from the Phase 2 study continue to indicate that TFF TAC dosing results in reduced systemic
variability of tacrolimus; the systemic tacrolimus trough to peak concentration swings that occur with oral tacrolimus are not present
with TFF TAC, which is predicted to reduce the risk of organ rejection and systemic toxicities such as chronic kidney disease. |
| ● | Confirmatory biomarker data from the Phase 2 study also remain positive: |
| ○ | Updated biomarker data indicate a 6.5-fold reduction in the number of abnormally expressed rejection-related
gene sets after 12 weeks of treatment with TFF TAC. These data further suggest TFF TAC has the potential to provide sufficient immunosuppression
to prevent rejection |
| ■ | 23.2% to 3.6% reduction (-85%) in the expression of rejection related genes: |
| ○ | New biomarker data exploring the presence of donor-specific antibodies (DSA) are now available in
the first 8 patients from the study. DSA is known to drive antibody-mediated rejection and is generated when there is insufficient immune
suppression systemically allowing the formation of antibodies in the lymph nodes against the transplanted (donor) organ. DSA was negative
for the first 8 patients on oral tacrolimus, and DSA remained negative after 12 weeks of treatment with TFF TAC. |
| ● | With respect to TFF TAC safety and tolerability, there has been no mortality. The majority of treatment
emergent adverse events were Grade 2 (moderate) or lower with no bronchospasm or wheezing reported. Kidney function has been maintained.
|
| ● | One patient was transitioned to a dose of TFF TAC that was too low, which led to blood trough levels
that were >50% below the protocol-specified minimum. This patient experienced signs and symptoms of acute rejection (but minimal on
histopathology). TFF TAC was discontinued as required by the protocol and oral tacrolimus was resumed. The acute rejection episode has
resolved. |
| ● | TFF is finalizing the design of the next study with TFF TAC in close collaboration with clinical
investigators and in communication with regulatory authorities and plans to provide additional updates on the program including a regulatory
update later in the fall. |
“As the number of patients
treated in our Phase 2 study continues to grow, we are highly encouraged by the emerging positive product profile for TFF TAC,”
said Dr. Zamaneh Mikhak, Chief Medical Officer of TFF Pharmaceuticals. “For this update, we showed the available new data related
to DSA for the first eight patients in the study. This analysis indicates that no patients have developed DSA after transitioning from
oral tacrolimus to TFF TAC, suggesting sufficient systemic immune suppression to inhibit production of potentially harmful antibodies
despite the modest decrease in blood trough levels. In addition, our updated gene expression data from now 8 patients show a dramatic
6.5-fold reduction in the number of abnormally expressed rejection-related gene sets, suggesting that TFF TAC has the potential to impart
sufficient levels of immunosuppression to prevent rejection.”
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 skin.
SAFE HARBOR
This press release contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such forward-looking statements in this press release include, but are not limited to, statements
by the Company relating to the innovation and commercial potential of the Company’s TFF TAC product candidate to advance the field
of immunosuppressive therapy to prevent lung transplant rejection. Forward-looking statements involve known and unknown risks, uncertainties
and other factors that could cause actual results to differ materially, including (i) the risk that further data from the Company’s
ongoing Phase 2 trial of TFF TAC may not be consistent with the positive preliminary data obtained to date, (ii) the risk that the Company
may not be able to obtain additional working capital with which to continue its current operations and clinical trials as and when needed,
(iii) success in early phases of pre-clinical and clinical 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, and (vi) 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 May 14, 2024. The Company cautions readers not to place undue reliance
on any forward-looking statements. The Company 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
Exhibit
99.2
1 NASDAQ: TFFP TFF TAC Updated Phase 2 Clinical Data Release August 6, 2024 BETTER DELIVERY, BETTER THERAPY | Powerful Drug Delivery Solutions
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 benefits of our TFF platform; advancement of TFF TAC into potentially registration - enabling studies; TFF TAC’s substantial market opportunity; and the expectation that the further data from the ongoing Phase 2 clinical trial for TFF TAC will be consistent with the data readouts for each product candidate to date. 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 trial for TFF TAC will not be favorably consistent with the preliminary positive data obtained to date, (ii) the risk that the Company may not be able to obtain additional working capital to continue its current operations and clinical trials as and when needed, (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, and (vi) 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 May 14, 2024 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 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 TFF TAC delivers tacrolimus directly to the lung to drive efficacy while limiting systemic exposures thus toxicities 1. Costa, Benvenuto, and Sonett, Best Practice & Research Clinical Anesthesiology , 2017 2. Lung levels were compared with blood levels in the 28 - day and 26 - week toxicology studies in cynomolgus monkeys 3. UpToDate; OPTN, UNOS, and Transplant Literature 4. Internal estimates TFF TAC is intended to optimize lung immune suppression at diminished systemic exposures thus systemic toxicities Lower efficacy, Higher adverse events Higher efficacy, Lower adverse events Oral tacrolimus is first line calcineurin inhibitor in lung transplantation. High systemic levels are needed with oral tacrolimus to prevent lung allograft rejection. High unmet need. 50% mortality in 5 years 1 is driven by : • Too little immune suppression in the lung: • Acute rejection • Chronic rejection • Chronic lung allograft dysfunction (CLAD) • Too much immune suppression in the blood: • Chronic kidney disease • Infections • Post - transplant malignancies Oral tacrolimus TFF TAC TFF TAC compared to oral tacrolimus: • 3 - 4 times systemic bioavailability • 3 - 4 times lung levels compared to blood levels 2 • Diminished blood level variability ~40,000 new and existing patients worldwide 3 ≥ $2 billion peak TFF TAC global gross sales forecast 4
4 TFF TAC: Phase 2 Study (TFF - T2 - 001) Design in Lung Transplant Patients Tac dosing • Design : Open label study of TFF TAC lung transplant recipients requiring reduced tac blood levels due to renal toxicity • Duration : Part A : 12 weeks; Part B : optional long - term extension • Endpoints : Safety & tolerability, renal function, acute allograft rejection Screening Day 1 2 weeks Week 12 Part A: Treatment Part B: Optional long - term extension • Bronchoscopy & mucosal biopsy MMDx • Spirometry • Donor - derived cell - free DNA assay • Donor - Specific Antibody (DSA) • Chest imaging TFF TAC • Bronchoscopy & mucosal biopsy MMDx • Spirometry • Donor - derived cell - free DNA assay • Donor - Specific Antibody (DSA) • Chest imaging Oral Tac TFF TAC MMDx: Molecular Microscope Diagnostic System
Data Release Highlights • Patient Enrollment Has Accelerated with 13 Patients Now Enrolled in Phase 2 Trial • TFF TAC at ~20% of the oral tacrolimus dose prevented acute rejection and achieved ~84% of the oral trough blood levels leading to diminished drug burden • 9 out of 9 (100%) Patients Who Completed the 12 - Week Treatment Chose to Remain on TFF TAC by Proceeding to the Long - Term Extension Phase • 2 patients have been treated for over a year and 6 patients have been treated for more than 6 months • 85% (6.5 - Fold) Reduction in the Number of Abnormally Expressed Rejection - Related Gene Sets after treatment with TFF TAC • No production of Donor - Specific Antibodies (DSA) after Treatment with TFF TAC 5 Data is from TFF - T2 - 001 pre - database lock; Data cut off date of 7/23/24 includes 12 patients; one additional patient enrolled by 8/6/24
TFF TAC (TFF - T2 - 001) Clinical Data Update 6
TFF TAC: Baseline Characteristics and Demographics Data is from TFF - T2 - 001 pre - database lock; Data cut off date of 7/23/24 includes 12 patients; one additional patient enrolled by 8/6/24 7 CLAD: chronic lung allograft dysfunction W: white; F: female; M: male; NH: Native Hawaiian N/A: not available Disposition Time on TFF Tac (weeks) Years with kidney disease CLAD Years since transplant Race Sex Age (years) Patient Completed Part A; proceeded to Part B 66.1 5 No 9 W M 73 Pt 1 Completed Part A; proceeded to Part B 57.1 6 No 8 W F 73 Pt 2 Completed Part A; proceeded to Part B 50.1 4 No 5 W M 68 Pt 3 Completed Part A; proceeded to Part B 37.1 2.5 No 3 W F 67 Pt 4 Completed Part A; proceeded to Part B 29.0 2.5 No 3 W M 64 Pt 5 Completed Part A; proceeded to Part B 26.1 7 No 23 W F 52 Pt 6 Completed Part A; proceeded to Part B 23.0 0.5 No 0.75 W F 41 Pt 7 Study drug discontinued in Part A 6.0 1 No 1.25 NH M 56 Pt 8 Completed Part A; proceeded to Part B 13.6 1.5 No 1.5 W M 29 Pt 9 Completed Part A; proceeded to Part B 12.0 4.5 No 4.5 W M 55 Pt 10 In Part A 7.0 2.5 No 3 W M 73 Pt 11 In Part A 1.0 N/A No 10 W M 69 Pt 12
TFF TAC: Total Patient Exposure 200 150 100 50 0 250 300 350 Weeks Pt 12 Pt 11 Pt 10 Pt 9 Pt 8 Pt 7 Pt 6 Pt 5 Pt 4 Pt 3 Pt 2 Pt 1 Cumulative Data is from TFF - T2 - 001 pre - database lock; Data cut off date of 7/23/24 includes 12 patients; one additional patient enrolled by 8/6/24 8 Total patient exposure represents 2,063 days, 5.65 years
9 Variability in metabolism contributes to individualized dosing with oral Tacrolimus and TFF TAC. NA: not applicable; Blank indicates data not yet available Data is from TFF - T2 - 001 pre - database lock; Data cut off date of 7/23/24 includes 12 patients; one additional patient enrolled by 8/6/24 TFF TAC at a fraction of the oral dose maintains systemic exposure Time on stable dose (weeks) Tacrolimus trough blood levels on stable TFF TAC (ng/ml) Stable TFF TAC dose (mg) Last trough level on initial dose of TFF TAC (ng/ml) Initial TFF TAC dose (mg) Tacrolimus trough level on stable oral Tacrolimus (ng/ml) Stable daily oral Tacrolimus dose (mg) Patient 55 2.4 - 3.0 0.75 5.1 1.5 5.6 5 Pt 1 56 2.2 - 3.9 0.25 13.6 1.5 3.9 1 Pt 2 11 4.4 0.75 3.2 0.75 4.6 5.5 Pt 3 28 2.6 - 3.8 0.5 3.9 0.75 4.5 2 Pt 4 25 2.4 - 3.1 0.375 4.0 0.5 5.1 3 Pt 5 10 3.2 - 3.6 0.5 4.8 0.75 3.8 3 Pt 6 23 4.5 - 6.9 1.5 6.2 1.5 5.4 13 Pt 7 NA NA NA 2.1 0.5 8.9 6 Pt 8 11 4.7 - 8.5 0.25 3.9 0.25 6 1 Pt 9 12 2.5 - 3.5 0.75 3.5 0.75 4.9 9 Pt 10 6 4.2 - 5.7 0.5 1.4 0.25 5.1 1 Pt 11 9.1 3 Pt 12 Stable Trough Tacrolimus Blood Levels: TFF TAC / Oral Tacrolimus Mean Stable TFF TAC Dose / Mean Stable Oral Tacrolimus Dose ~84% ~20%
Stable Trough Tacrolimus Blood Levels: TFF TAC / Oral Tacrolimus Mean Stable TFF TAC Dose / Mean Stable Oral Tacrolimus Dose ~84% ~20% n=12 Efficacy • 13 patients transitioned from oral tacrolimus to TFF TAC; transition data available on 11 patients • Among 10 patients transitioned to TFF TAC per protocol: • 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 • No biomarker evidence of acute rejection (gene expression and donor - specific antibody) • 9/9 patients who completed treatment in Part A chose to remain on TFF TAC and proceeded to Part B Data is from TFF - T2 - 001 pre - database lock; Data cut off date of 7/23/24 includes 12 patients; one additional patient enrolled by 8/6/24 10 Safety • No mortality • One TFF TAC discontinuation: • One patient was transitioned to a dose of TFF TAC that was too low, which led to blood trough levels that were >50% below the protocol - specified minimum. This patient experienced signs and symptoms of acute rejection (but minimal on histopathology). TFF TAC was discontinued as required by the protocol and oral tacrolimus was resumed. The acute rejection episode has resolved. • Majority of TEAEs were Grade 2 or lower in severity • Maintenance of kidney function Key Takeaways • 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 doses and systemic exposures
TFF TAC: 85% reduction in the number of abnormally expressed rejection - related gene sets after treatment with TFF TAC Abnormal Slightly Abnormal Normal 1.625 1.750 3.625 Number of rejection - related gene sets on oral tacrolimus 0.250 1.625 5.125 Number of rejection - related gene sets on TFF TAC n=8 Molecular Microscope Diagnostic System (MMDX): • Gene expression profiling in mucosal and endobronchial biopsies to assess risk of rejection and injury in transplanted organs • Endobronchial biopsies are obtained before start of TFF TAC and after 12 weeks of treatment 51.8% 25.0% Oral Tacrolimus: Rejection - Related Gene Sets Normal Slightly Abnormal Abnormal 23.2% 73.2% 23.2% 3.6% TFF TAC: Rejection - Related Gene Sets Normal Slightly Abnormal Abnormal Data is from TFF - T2 - 001 pre - database lock; Data cut off date of 7/23/24 includes 12 patients; one additional patient enrolled by 8/6/24 11
12 TFF TAC Prevents Formation of Donor - Specific Antibodies Donor - Specific Antibody ( DSA): • Donor - specific antibodies are generated when there is insufficient immune suppression systemically allowing the formation of antibodies in the lymph nodes against the transplanted (donor) organ • Donor - specific antibodies drive antibody - mediated rejection • Donor - specific antibody levels were measured at screening while on oral tacrolimus and after 12 weeks of treatment with TFF TAC. DSA data for pre - and post - treatment with TFF TAC were available from 8 patients. All patients were negative on oral tacrolimus and continued to be negative after 12 weeks of treatment with TFF TAC DSA levels Day 85 Screening Patient Negative Negative Pt 1 Negative Negative Pt 2 Negative Negative Pt 3 Negative Negative Pt 4 Negative Negative Pt 5 Negative Negative Pt 6 Negative Negative Pt 7 Negative Negative Pt 8 Data is from TFF - T2 - 001 pre - database lock; Data cut off date of 7/23/24 includes 12 patients; one additional patient enrolled by 8/6/24
Data Release Highlights • Patient Enrollment Has Accelerated with 13 Patients Now Enrolled in Phase 2 Trial • TFF TAC at ~20% of the oral tacrolimus dose prevented acute rejection and achieved ~84% of the oral trough blood levels leading to diminished drug burden • 9 out of 9 (100%) Patients Who Completed the 12 - Week Treatment Chose to Remain on TFF TAC by Proceeding to the Long - Term Extension Phase • 2 patients have been treated for over a year and 6 patients have been treated for more than 6 months • 85% (6.5 - Fold) Reduction in the Number of Abnormally Expressed Rejection - Related Gene Sets after treatment with TFF TAC • No production of Donor - Specific Antibodies (DSA) after Treatment with TFF TAC 13 Data is from TFF - T2 - 001 pre - database lock; Data cut off date of 7/23/24 includes 12 patients; one additional patient enrolled by 8/6/24
THANK YOU 14
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