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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 14, 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 2.02
Results of Operations and Financial Condition.
On
August 14, 2024, TFF Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the
fiscal quarter ended June 30, 2024. A copy of the press release is attached as Exhibit 99.1 to this Current Report and is incorporated
herein by reference.
The
information in this Item 2.02, including the press release attached as Exhibit 99.1, is furnished pursuant to Item 2.02 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 it 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 14, 2024 |
/s/
Kirk Coleman |
|
Kirk
Coleman, |
|
Chief
Financial Officer |
2
Exhibit 99.1
TFF
Pharmaceuticals Reports Second Quarter Financial Results and Provides Corporate Update
FORT WORTH, TX – August 14, 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 reported financial results for the
second quarter 2024 and provided a corporate update.
“Over the last several months,
we have amassed a growing body of positive safety, efficacy and confirmatory biomarker data from our Phase 2 program that points towards
TFF TAC becoming a significant new advancement for the prevention of lung transplant rejection,” said Harlan Weisman, M.D., Chief
Executive Officer of TFF Pharmaceuticals. “Given our current financial resources, we are continuing to evaluate a number of different
strategies to advance the TFF TAC clinical program in the most efficient manner possible.”
Recent Clinical and Corporate Highlights:
| ● | The Company recently provided an update from the ongoing Phase
2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant rejection. |
| ● | Patient enrollment has accelerated
with 13 patients now enrolled |
| ● | 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 |
| ● | 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 |
| ● | PK data 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 also remain positive: |
| o | 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 compared
to oral tacrolimus. These data further suggest TFF TAC has the potential to provide sufficient immunosuppression to prevent rejection;
there was a reduction in expression of rejection-related gene sets from 23% abnormal while on oral tacrolimus to only 3.6% abnormal after
treatment with TFF TAC (an 85% reduction). |
| o | 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 and the spleen 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 of acute rejection (Grade A1, which is minimal
severity based 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 is in communication with regulatory authorities and plans to provide additional updates on the program including a regulatory
update later in the fall. |
| ● | In June 2024, the Company announced that it engaged Outcome Capital as a strategic advisor for the purpose of evaluating potential
corporate partnerships and licensing opportunities. |
| ● | In May 2024, the Company announced that the U.S. government will be advancing several next-generation medical countermeasures (MCMs)
formulated with its Thin Film Freezing technology into advanced preclinical testing. TFF Pharmaceuticals is collaborating with Leidos,
a leading Fortune 500 information technology, engineering and science solutions and services leader, to develop next-generation MCMs designed
to protect military and healthcare personnel against future chemical and biological (CB) threats. The research is funded by the Defense
Advanced Research Projects Agency (DARPA) under a contract through the Personalized Protective Biosystems (PPB) program. |
| ● | In May 2024, the Company announced that, in collaboration with the Cleveland Clinic, TFF Pharmaceuticals is advancing multiple multivalent
universal influenza vaccines to protect against seasonal and pandemic viruses into preclinical testing. The decision to advance the vaccine
candidates into preclinical testing was based upon the successful completion of formulation testing with stability data on the combination
of hemagglutinin (HA) antigens with four different adjuvants. Based on these data, three HA antigen/adjuvant candidate vaccines have been
selected for testing in a pre-clinical model at Cleveland Clinic Florida. |
Second Quarter 2024 Financial Results
Balance Sheet Highlights
| ● | As of June 30, 2024, TFF Pharmaceuticals cash and
cash equivalents were approximately $4.4 million. On May 1, 2024, the Company completed a registered direct offering, receiving
gross proceeds of $4.8 million before deducting offering expenses. |
Operating Results
| ● | Research and Development (R&D) expenses were $2.6 million
for the quarter ended June 30, 2024, a decrease of $0.1 million, or 3%, compared to $2.7 million for the quarter ended June 30, 2023.
The net decrease of $0.1 million was primarily related to a decrease of $0.3 million in manufacturing and related expenses, offset by
an increase of $0.2 million in compensation-related expenses. |
| ● | General & Administrative (G&A) expenses were $2.0 million
for the quarter ended June 30, 2024, a decrease of $0.7 million, or 24%, compared to $2.7 million for the quarter ended June 30, 2023.
The net decrease of $0.7 million was primarily related to decreases of $0.5 million in compensation-related expenses and $0.2 million
in insurance expenses. |
| ● | Net Loss: Net loss was $4.5 million for the quarter ended June 30, 2024, a decrease of $0.5 million,
compared to a net loss of $5.0 million for the quarter ended June 30, 2023. |
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 candidates. 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 August 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:
Jason Nelson
CoreIR
jason@coreir.com
TFF PHARMACEUTICALS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Revenue | |
$ | 650,222 | | |
$ | 333,351 | | |
$ | 853,495 | | |
$ | 384,780 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 2,588,316 | | |
| 2,681,898 | | |
| 6,144,178 | | |
| 6,700,557 | |
General and administrative | |
| 2,024,473 | | |
| 2,670,363 | | |
| 4,462,777 | | |
| 5,789,579 | |
Total operating expenses | |
| 4,612,789 | | |
| 5,352,261 | | |
| 10,606,955 | | |
| 12,490,136 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (3,962,567 | ) | |
| (5,018,910 | ) | |
| (9,753,460 | ) | |
| (12,105,356 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest income, net | |
| 43,819 | | |
| 36,120 | | |
| 99,568 | | |
| 71,199 | |
Change in fair value of note receivable | |
| (560,473 | ) | |
| (37,416 | ) | |
| (560,473 | ) | |
| (37,416 | ) |
Total other income (expense), net | |
| (516,654 | ) | |
| (1,296 | ) | |
| (460,905 | ) | |
| 33,783 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (4,479,221 | ) | |
$ | (5,020,206 | ) | |
$ | (10,214,365 | ) | |
$ | (12,071,573 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share, basic and diluted | |
$ | (1.22 | ) | |
$ | (3.47 | ) | |
$ | (3.37 | ) | |
$ | (8.34 | ) |
Weighted average common shares outstanding, basic and diluted | |
| 3,667,264 | | |
| 1,447,723 | | |
| 3,027,585 | | |
| 1,447,723 | |
TFF PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| |
June 30,
2024 | | |
December 31,
2023 | |
| |
(Unaudited) | | |
| |
| |
| | |
| |
ASSETS | |
| | |
| |
Current assets: | |
| | |
| |
Cash and cash equivalents | |
$ | 4,387,198 | | |
$ | 5,478,113 | |
Research and development tax incentive receivable | |
| 400,881 | | |
| 433,852 | |
Prepaid assets and other current assets | |
| 1,092,096 | | |
| 1,678,353 | |
Total current assets | |
| 5,880,175 | | |
| 7,590,318 | |
Operating lease right-of-use asset, net | |
| 78,924 | | |
| 119,529 | |
Property and equipment, net | |
| 1,759,611 | | |
| 1,999,781 | |
Investment in Vaxanix | |
| 1,776,746 | | |
| - | |
Note receivable - Augmenta | |
| - | | |
| 2,310,000 | |
Other assets | |
| - | | |
| 7,688 | |
Total assets | |
$ | 9,495,456 | | |
$ | 12,027,316 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 1,358,876 | | |
$ | 958,442 | |
Accrued liabilities | |
| 2,160,140 | | |
| 1,285,586 | |
Deferred research grant revenue | |
| 25,000 | | |
| 101,000 | |
Current portion of operating lease liability | |
| 74,124 | | |
| 83,512 | |
Total current liabilities | |
| 3,618,140 | | |
| 2,428,540 | |
Operating lease liability, net of current portion | |
| - | | |
| 31,742 | |
Total liabilities | |
| 3,618,140 | | |
| 2,460,282 | |
| |
| | | |
| | |
Commitments and contingencies | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock | |
| 3,246 | | |
| 2,370 | |
Additional paid-in capital | |
| 134,604,851 | | |
| 128,044,509 | |
Accumulated other comprehensive loss | |
| (184,763 | ) | |
| (148,192 | ) |
Accumulated deficit | |
| (128,546,018 | ) | |
| (118,331,653 | ) |
Total stockholders’ equity | |
| 5,877,316 | | |
| 9,567,034 | |
Total liabilities and stockholders’ equity | |
$ | 9,495,456 | | |
$ | 12,027,316 | |
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TFF Pharmaceuticals (NASDAQ:TFFP)
過去 株価チャート
から 7 2024 まで 8 2024
TFF Pharmaceuticals (NASDAQ:TFFP)
過去 株価チャート
から 8 2023 まで 8 2024