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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 1, 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 5.02 Departure of Directors or Certain Officers; Election of
Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
On December 1, 2023, our Board
of Directors, or Board, acting on the recommendation of the Board’s Nominating and Corporate Governance Committee, appointed Catherine
Lee and Michael Patane to serve as directors of TFF Pharmaceuticals, Inc. until our next annual meeting of the stockholders and until
their respective successors are elected and qualified or until their earlier resignation or removal. Our Board also appointed Ms. Lee
to the Nominating and Corporate Governance Committee of the Board and appointed Mr. Patane to the Compensation Committee of the Board.
In connection with their
appointments, and pursuant to our previously disclosed independent director compensation policy, the Compensation Committee of the
Board approved the grant of an option to Ms. Lee and Mr. Patane, each, under our 2021 Stock Incentive Plan to purchase 132,442
shares of our common stock at an exercise price of $0.36 per share. The options vest and first become exercisable in 36 equal monthly
installments, with the first installment vesting on December 1, 2024 and the remaining installments on the 1st day of the month over
the next 35 months. The options have a term of ten years from the date of grant and are otherwise subject to our 2021 Stock
Incentive Plan.
We issued
separate press releases announcing the appointments of Ms. Lee and Mr. Patane. Those press releases are attached hereto as Exhibits 99.1
and 99.2.
Item 9.01 Financial Statements and Exhibits
| (d) |
Exhibits |
Method of Filing |
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 4, 2023 |
/s/ Kirk Coleman |
| |
Kirk Coleman, |
| |
Chief Financial Officer |
2
Exhibit 99.1
TFF Pharmaceuticals Appoints Catherine
Lee, J.D. to Board of Directors
FORT WORTH, Texas, Nov. 30, 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 Catherine Lee, J.D.
has been appointed to its Board of Directors.
“We are pleased to announce the appointment
of Catherine Lee to our Board of Directors,” said Harlan Weisman, M.D., Chief Executive Officer of TFF Pharmaceuticals. “Cathy
brings an extensive track record of accomplishment within the life sciences sector, serving as the General Counsel and Corporate Secretary
for multiple companies and advising them on key growth initiatives and strategic transactions. As TFF Pharmaceuticals continues to advance
its two clinical programs, Cathy’s presence on our Board will help shape our decision-making, both with respect to product development,
strategic and operational planning, and potential partnership opportunities.
“I am pleased to be joining the Board
of TFF Pharmaceuticals at such an exciting time in the company’s history,” said Ms. Lee. “With the upcoming data readouts
for its Phase 2 programs and a technology platform that continues to gain recognition among industry, government, and academia, TFF Pharmaceuticals
is poised to enter a new phase of growth, and I look forward to working with Harlan and the other Board members to help advance the company’s
strategic initiatives.”
With over 25+ years of legal and business
experience, Ms. Lee is a strategic thought partner to executive teams, supporting both private and public emerging growth organizations.
Ms. Lee currently advises Neogene Therapeutics,
Inc., a private cell therapy company that was acquired by AstraZeneca in January 2023, on a variety of legal matters. From February 2022
to September 2023, she served as Neogene’s General Counsel, where she helped lead Neogene’s acquisition by AstraZeneca for
up to $320MM. Prior to Neogene, Cathy served as Executive Vice President, General Counsel and Corporate Secretary of Metacrine, Inc, where
she effected the $85MM initial public offering of the company and built the legal, corporate governance and compliance infrastructure
to support its transition from a private to publicly traded company. Prior to Metacrine, Cathy served as Senior Vice President, General
Counsel of Omniome where she negotiated and completed a $60MM Series C financing and prepared the company for commercial launch, advised
on IP strategy and potential litigation considerations, secured licenses, manufacturing and supply arrangements and supported a 50% growth
of the company’s work force. Prior to Omniome, Cathy served as Senior Vice President, General Counsel and Corporate Secretary with
Senomyx, Inc., where she successfully led the company and its board through a proxy contest, and eventually helped lead the company’s
acquisition by Firmenich.
Cathy began her career at Morrison & Foerster,
LLP and Brobeck, Phleger & Harrison before transitioning into her in-house counsel roles. She received her J.D. from the University
of Illinois, College of Law and her B.A. in International Relations and Economics, magna cum laude, from the American University, School
of International Service.
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.
Exhibit 99.2
TFF Pharmaceuticals Appoints Michael Patane,
Ph.D., to Board of Directors
FORT WORTH,
Texas, Nov. 30, 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 Michael Patane, Ph.D., to its Board of Directors.
“I am pleased to welcome Dr. Patane
to our Board of Directors,” said Harlan Weisman, M.D., Vice Chairman and Chief Executive Officer of TFF Pharmaceuticals. “Mike’s
career spans over two decades of leadership experience in drug discovery and development, and he has demonstrated an extraordinary ability
to turn scientific success into corporate achievements. His depth of experience and insights will clearly be significant assets to our
Board, as we continue to advance our two clinical candidates, TFF VORI and TFF TAC, while seeking to maximize the value of our Thin Film
Freezing technology platform.”
“I am happy to join Harlan and his fellow
Board members at TFF Pharmaceuticals,” said Dr. Patane. “The team at TFF has established an impressive track record, which
includes advancing two clinical-stage assets utilizing their ground-breaking formulation technology, Thin Film Freezing. Optimizing drug
formulations to achieve sufficient biodistribution for pharmacological activity is mission critical for the success of any drug development
program. Based on earlier Phase 1 data and initial compassionate use cases, Thin Film Freezing has already demonstrated its value in the
clinic, and I believe there remains significant untapped opportunity to apply this innovative technology across a broad range of drug
development programs.”
Dr. Patane has 25 years of drug discovery
and development experience in leadership roles within start-up, biotechnology and global biopharmaceutical companies with broad therapeutic
area experience. Most recently, Mike served as President of Mitobridge, Inc. (a wholly owned subsidiary of Astellas), where he oversaw
all operations and represented the organization at global interfaces. As part of the pre-Series A team, Mike helped shape the Company’s
vision and strategy that culminated in its Series A financing ($45MM), a strategic alliance with Astellas ($30MM non-dilutive) and the
acquisition by Astellas ($450MM, $225MM upfront, $338MM currently realized) within four years. Prior to his promotion to President of
Mitobridge, Mike served as the company’s Chief Scientific Officer and earlier as its Senior Vice President, Drug Discovery.
Before joining Mitobridge, Mike served as
Chief Scientific Officer of Eyegate Pharmaceuticals, Inc. (now Kiora Pharmaceuticals), where he was responsible for discovering and developing
ocular therapeutics utilizing a proprietary iontophoresis system in combination with novel drug product formulations. Earlier in his career,
Mike was a Director of Global Discovery Chemistry with Novartis Institutes for Biomedical Research, and prior to Novartis, he was a Director
of Medicinal Chemistry with Millennium Pharmaceuticals, where he was responsible for oncology and metabolic diseases drug discovery.
Mike began his career as a Research Fellow,
Medicinal Chemistry with Merck & Co. He conducted his post-doctoral research at The Scripps Research Institute focusing on natural
products synthesis. He received his Ph.D. in synthetic organic chemistry from the University of Southern California and his B.S. degree
in chemistry from Fordham University.
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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