TFFP TFF Pharmaceuticals Inc

 

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:

 

Exhibit 99.1	Press release dated August 14, 2024 regarding the Registrant’s financial results for its fiscal quarter ended June 30, 2024	Filed Electronically herewith
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

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

 

 

5

 

v3.24.2.u1

Cover	Aug. 14, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 14, 2024
Entity File Number	001-39102
Entity Registrant Name	TFF PHARMACEUTICALS, INC.
Entity Central Index Key	0001733413
Entity Tax Identification Number	82-4344737
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	1751 River Run
Entity Address, Address Line Two	Suite 400
Entity Address, City or Town	Fort Worth
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	76107
City Area Code	(817)
Local Phone Number	438-6168
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock: Par value $.001
Trading Symbol	TFFP
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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