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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 11, 2023
TFF
PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware |
|
001-39102 |
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82-4344737 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission File Number) |
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(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
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|
Trading Symbol(s)
|
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Name of each exchange on which registered
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Common stock: Par value $.001 |
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TFFP |
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Nasdaq Capital Market |
Item 5.02 Departure of Directors or Certain Officers; Election of
Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
On December 11, 2023, our
Board of Directors, or Board, acting on the recommendation of the Board’s Nominating and Corporate Governance Committee, appointed
Thomas King to serve as a director of TFF Pharmaceuticals, Inc. until our next annual meeting of the stockholders and until his successor
is elected and qualified or until his earlier resignation or removal.
In connection with his appointment,
and pursuant to our previously disclosed independent director compensation policy, the Compensation Committee of the Board approved the
grant of an option to Mr. King under our 2021 Stock Incentive Plan to purchase 132,442 shares of our common stock at an exercise price
of $0.35 per share. The option vests and first becomes exercisable in 36 equal monthly installments, with the first installment vesting
on December 13, 2024 and the remaining installments on the 13th day of the month over the next 35 months. The option has a term of ten
years from the date of grant and is otherwise subject to our 2021 Stock Incentive Plan.
On December 13, 2023, we issued
a press release announcing the appointment of Mr. King. The press release is attached hereto as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits
(d) |
Exhibits |
Method of Filing |
The following exhibit is 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.
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TFF PHARMACEUTICALS, INC.
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Dated: December 15, 2023 |
/s/ Kirk Coleman |
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Kirk Coleman, |
|
Chief Financial Officer |
2
Exhibit 99.1
TFF Pharmaceuticals Appoints Thomas B.
King to Board of Directors
FORT WORTH, Texas, Dec. 13, 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 the appointment of Thomas
B. King to its Board of Directors.
“I am pleased to welcome Thomas King
to our Board of Directors,” said Harlan Weisman, M.D., Vice Chairman and Chief Executive Officer of TFF Pharmaceuticals. “Tom
is an exceptionally accomplished executive who has held leadership positions at life sciences companies over the last three decades. In
addition, his extensive board experience will provide us with valuable insights and perspectives as we seek to advance our two lead candidates,
TFF VORI and TFF TAC, into later-stage clinical testing.”
“I am very excited to join the Board
of TFF Pharmaceuticals at a time when the Company is demonstrating how its ground-breaking Thin Film Freezing technology can be applied
in the clinic to address the significant unmet need in patients with rare diseases,” said Mr. King. “I look forward to working
alongside Harlan and our fellow Board members to help advance the company’s mission of significantly improving new and existing
therapies for the benefit of patients.”
Mr. King has over 30 years of executive leadership
and board experience in the life sciences industry. Presently, Mr. King sits on the board of several companies, including Achieve Life
Sciences (Nasdaq: ACHV), Kinaset Therapeutics, and Concentric Analgesics. From 2003 to 2016, Mr. King served as the President, Chief Executive
Officer and Director of Alexza Pharmaceuticals, where he led multiple stock offerings and debt transactions from 2003 through 2015 (IPO
in 2006), raising in excess of $600mm and ultimately leading to the successful M&A transaction with Grupo Ferrer. Prior to joining
Alexza, he was the President, Chief Executive Officer and Director of Cognetix, Inc. From 1994 to 2000, Mr. King served in multiple executive
roles and as a Director with Anesta Corp., where he led two successful follow-on stock offerings, NDA and MAA approvals for oral transmucosal
fentanyl citrate (Actiq®), and a successful M&A transaction with Cephalon in 2000.
Earlier in his career, Mr. King served as
Vice President of Marketing and Business Development with Somatogen, Inc., and before joining Somatogen, he served as Director of the
Cardiovascular Business Unit at Abbott Laboratories, Pharma Products Division. Mr. King received his B.A. degree in chemistry from McPherson
College and an MBA from the University of Kansas Graduate School of Business.
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 may not be able to release initial clinical data
for TFF VORI and TFF TAC by the end of 2023 or, if it is able to do so, that such clinical data will be positive, (ii) the risk that the
Company’s preclinical and IND enabling studies of the dry powder formulation of the universal influenza vaccine may not be successful,
(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, 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
Source: TFF Pharmaceuticals, Inc.
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TFF Pharmaceuticals (NASDAQ:TFFP)
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TFF Pharmaceuticals (NASDAQ:TFFP)
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