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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):
May 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 May 14, 2024, TFF Pharmaceuticals,
Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended March 31, 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: May 14, 2024 |
/s/ Kirk Coleman |
|
Kirk Coleman, |
|
Chief Financial Officer |
Exhibit 99.1
TFF
Pharmaceuticals Reports First Quarter Financial Results and Provides Corporate Update
Growing
Body of Clinical Data from Ongoing Phase 2 Trial Suggests that Tacrolimus Inhalation Powder (TFF TAC) Could Represent an Important New
Innovation for Optimizing Immunosuppressive Therapy in Lung Transplant Recipients
Raised
$6.0 Million to Support Continued Advancement of TFF TAC into Potentially Registrational Testing
Company
expects to receive feedback from FDA in Second Quarter Regarding TFF TAC Clinical Development Plan and Next Steps
FORT
WORTH, TX – May 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 first quarter 2024 and provided a corporate update.
“We
continue to make significant progress in demonstrating that Tacrolimus Inhalation Powder (TFF TAC) has the potential to become an important
new advancement in transplant medicine,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “Following
the positive physician feedback for our updated Phase 2 study presented at this year’s International Society for Heart and Lung
Transplantation (ISHLT) meeting, we submitted a briefing book, inclusive of our proposed study plan, to the FDA. We expect to receive
feedback from the FDA this quarter that will help guide our next steps in the clinical development pathway for TFF TAC. I am also pleased
to note that we were able to secure additional financing following the close of the quarter to help us further advance TFF TAC toward
registrational testing. Our Phase 2 study for TFF TAC continues to enroll additional patients, and we look forward to hosting a call
and presenting updated data from the trial later this year.”
Recent
Clinical and Corporate Highlights:
| ● | On
May 1, 2024, the Company announced the closing of its previously announced $4.8 million public offering. The Company intends to use the
net proceeds from this offering for working capital and general corporate purposes. This follows a $1.2 million public offering in March
2024. |
| ● | On
April 15, 2024, the Company announced additional positive data from its ongoing Phase 2 study evaluating TFF TAC) for the prevention
of organ rejection in lung transplant recipients. |
| o | New
gene expression analysis demonstrated normalization of rejection-related genes after treatment
with TFF TAC. |
| o | TFF
TAC prevented rejection at 1/6 of oral tacrolimus dose and with 2/3 of oral tacrolimus systemic
trough exposures |
| o | 4
out of 4 patients who completed the 12-week treatment have chosen to remain on TFF TAC by
proceeding to the safety extension phase |
| o | These
new data were presented by Professor Gregory Snell, the lead Principal Investigator of the
TFF TAC Phase 2 study, in an oral presentation ISHLT 44th Annual Meeting at a late breaking
clinical science abstract session, on April 13, 2024, in Prague, Czech Republic. |
| ● | On
March 27, 2024, the Company hosted a conference call and webcast to present new data from the ongoing Phase 2 study of TFF TAC for the
prevention of organ rejection in lung transplant recipients and from the Phase 2 study and the Expanded Access Program (EAP) of TFF Voriconazole
(TFF VORI) for the treatment of invasive pulmonary aspergillosis (IPA) infections. On the call, our executive leadership team disclosed
that: |
| o | Eight
out of eight patients (100%) successfully transitioned from oral Tacrolimus to TFF TAC in
the study. There was no evidence of acute rejection. Four out of the four patients who completed
the 12-week treatment period of the study chose to remain on TFF TAC and proceeded to the
long-term extension of the trial. TFF TAC demonstrated favorable safety results with no mortality
or discontinuations due to adverse events. |
| o | The
Company enrolled a total of nine patients in its TFF VORI clinical programs, inclusive of
its ongoing Phase 2 study and the EAP. Five of six patients who had completed treatment by
the data cut date achieved a clinical and mycologic response providing promising positive
efficacy data. TFF VORI maintained an attractive safety profile with no IPA-related mortality
or all-cause mortality. |
A
replay of the call and webcast can be accessed here.
| ● | In
March 2024, the Company announced that it prioritized the development of TFF TAC based on the positive data from the ongoing Phase 2
study, the potential of this product to address a significant unmet need in lung transplant medicine, and the substantial market opportunity.
With respect to TFF VORI, the Company announced that it is exploring strategic alternatives, including partnering opportunities, collaborations,
and government-based funding sources to support its continued development. |
| ● | In
January 2024, the Company presented data from the Phase 2 trial of TFF VORI at the Advances Against Aspergillosis & Mucormycosis
(AAAM) Conference, which was held from January 25-27, 2024, in Milan, Italy. The data presented at the AAAM Conference were first disclosed
by the Company in December 2023. These data showed that treatment with TFF VORI resulted in positive treatment outcomes while maintaining
a favorable safety/tolerability profile. |
First
Quarter 2024 Financial Results
Balance
Sheet Highlights
| ● | As
of March 31, 2024, TFF Pharmaceuticals cash and cash equivalents were approximately $3.2 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 $3.6 million for the quarter ended March 31, 2024, a decrease of $0.4 million, or 12%, compared
to $4.0 million for the quarter ended March 31, 2023. The net decrease of $0.4 million was primarily related to a decrease of $1.6 million
in manufacturing and related expenses, offset by increases of $0.8 million in clinical and preclinical expenses and $0.3 million in compensation-related
expenses. |
| | |
| ● | General
& Administrative (G&A) expenses were $2.4 million for the quarter ended March 31, 2024, a decrease of $0.7 million, or 22%, compared
to $3.1 million for the quarter ended March 31, 2023. The net decrease of $0.7 million was primarily related to decreases of $0.4 million
in compensation-related expenses, $0.2 million in market research expenses and $0.1 million in insurance expenses. |
| | |
| ● | Net
Loss: Net loss was $5.7 million for the quarter ended March 31, 2024, a decrease of $1.4 million, compared to a net loss of $7.1
million for the year ended March 31, 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 the skin. TFF Pharmaceuticals has two lead
drug candidates in the clinic: TFF TAC (Tacrolimus Inhalation Powder) and TFF VORI (Voriconazole Inhalation Powder). The Company continues
collaborations with a broad array of pharmaceutical companies, academic institutions, and government partners to revolutionize healthcare
around the globe. The TFF Platform is protected by over 170 patents issued or pending in the U.S. and internationally. To learn more
about TFF Pharmaceuticals and its product candidates, visit the Company’s website at https://tffpharma.com.
SAFE HARBOR
This
press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the advancement of TFF TAC into
potentially registration-enabling studies; the expectation that the FDA will provide feedback in second quarter regarding TFF
TAC clinical development and that any such feedback will be positive; the expectation that the initial data readouts for TFF TAC will
be consistent with the further data from the ongoing Phase 2 clinical trial; 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 trial for 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 its TFF TAC candidate, (iii) the risk that the FDA will not provide feedback in second quarter regarding TFF TAC clinical
development or that any such feedback will not be positive; (iv) success in early phases of pre-clinical and clinicals trials do not
ensure later clinical trials will be successful; (v) no drug product incorporating the TFF platform has received FDA pre-market approval
or otherwise been incorporated into a commercial drug product, (vi) the Company has no current agreements or understandings with any
large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vii) the risk that the Company
may not be able to obtain additional working capital with which to continue the Phase 2 clinical trial, or advance to the initiation
of registration-enabling studies, for TFF TAC as and when needed and (viii) those other risks disclosed in the section “Risk Factors”
included in the Company’s Annual Report on Form 10-Q filed with the SEC on May 14, 2024. 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
TFF
PHARMACEUTICALS, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| |
For The Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
| |
| | | |
| | |
Revenue | |
$ | 203,273 | | |
$ | 51,429 | |
Operating expenses: | |
| | | |
| | |
Research and development | |
| 3,555,862 | | |
| 4,018,659 | |
General and administrative | |
| 2,438,304 | | |
| 3,119,216 | |
Total operating expenses | |
| 5,994,166 | | |
| 7,137,875 | |
| |
| | | |
| | |
Loss from operations | |
| (5,790,893 | ) | |
| (7,086,446 | ) |
| |
| | | |
| | |
Other income: | |
| | | |
| | |
Interest income, net | |
| 55,749 | | |
| 35,079 | |
Total other income | |
| 55,749 | | |
| 35,079 | |
| |
| | | |
| | |
Net loss | |
$ | (5,735,144 | ) | |
$ | (7,051,367 | ) |
Net loss per share, basic and diluted | |
$ | (2.40 | ) | |
$ | (4.87 | ) |
| |
| | | |
| | |
Weighted average common shares outstanding, basic and diluted | |
| 2,387,906 | | |
| 1,447,723 | |
TFF
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
| |
March 31, 2024 | | |
December 31, 2023 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | |
| |
Current assets: | |
| | |
| |
Cash and cash equivalents | |
$ | 3,211,930 | | |
$ | 5,478,113 | |
Research and development tax incentive receivable | |
| 287,597 | | |
| 433,852 | |
Prepaid assets and other current assets | |
| 1,362,989 | | |
| 1,678,353 | |
Total current assets | |
| 4,862,516 | | |
| 7,590,318 | |
Operating lease right-of-use asset, net | |
| 99,431 | | |
| 119,529 | |
Property and equipment, net | |
| 1,879,696 | | |
| 1,999,781 | |
Note receivable - Augmenta | |
| 2,337,219 | | |
| 2,310,000 | |
Other assets | |
| 7,688 | | |
| 7,688 | |
Total assets | |
$ | 9,186,550 | | |
$ | 12,027,316 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 1,663,544 | | |
$ | 958,442 | |
Accrued liabilities | |
| 1,983,426 | | |
| 1,285,586 | |
Deferred research grant revenue | |
| 140,000 | | |
| 101,000 | |
Current portion of operating lease liability | |
| 84,300 | | |
| 83,512 | |
Total current liabilities | |
| 3,871,270 | | |
| 2,428,540 | |
Operating lease liability, net of current portion | |
| 10,856 | | |
| 31,742 | |
Total liabilities | |
| 3,882,126 | | |
| 2,460,282 | |
| |
| | | |
| | |
Commitments and contingencies | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock | |
| 2,519 | | |
| 2,370 | |
Additional paid-in capital | |
| 129,572,489 | | |
| 128,044,509 | |
Accumulated other comprehensive loss | |
| (203,787 | ) | |
| (148,192 | ) |
Accumulated deficit | |
| (124,066,797 | ) | |
| (118,331,653 | ) |
Total stockholders’ equity | |
| 5,304,424 | | |
| 9,567,034 | |
Total liabilities and stockholders’ equity | |
$ | 9,186,550 | | |
$ | 12,027,316 | |
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