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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): November 14, 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 2.02 Results of Operations and Financial Condition.

 

On November 14, 2023, TFF Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended September 30, 2023. 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 hereto, 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 November 14, 2023 regarding the Registrant’s financial results for its fiscal quarter ended September 30, 2023. Filed Electronically herewith
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)  

 

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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: November 14, 2023 /s/  Kirk Coleman
  Kirk Coleman,
  Chief Financial Officer

 

 

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Exhibit 99.1

 

TFF Pharmaceuticals Reports

Third Quarter 2023 Financial Results

and Provides Corporate Update

 

Company remains on track to report initial data from TFF VORI and TFF TAC Phase 2 trials by the end of 2023

 

Conference call and webcast, today Tuesday November 14, 2023, at 4:30 pm ET, to provide overview of expected data readouts from Phase 2 studies

 

FORT WORTH, TX – Nov 14, 2023 – 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 third quarter of 2023 and provided a corporate update.

 

“Based on the considerable progress that we have achieved over the last several months, we continue to expect initial data from our ongoing Phase 2 trials of TFF VORI and TFF TAC by year-end,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “TFF VORI and TFF TAC have been designed to address the significant unmet needs in two rare disease indications, each with high mortality rates in patient populations with very few treatment alternatives. We therefore expect these initial Phase 2 data will provide meaningful clinical insights on each drug’s safety, tolerability and efficacy to help guide our clinical development strategy as we enter into 2024.”

 

Recent Clinical and Corporate Highlights:

 

In November 2023, the Company announced the publication of research demonstrating the feasibility of intranasal delivery of monoclonal antibodies (mAbs) using the Company’s proprietary Thin Film Freezing technology. The paper, entitled “Feasibility of Intranasal Delivery of Thin-film Freeze-dried Monoclonal Antibodies”, was first published on October 24, 2023, by bioRxiv and can be found here.

 

●In August 2023, the Company announced the closing of a $5.7 million equity financing, including the full exercise of the underwriter’s overallotment option. The financing provided additional capital to extend the Company’s cash runway into Q22024.

 

●In July 2023, the Company and Durbin jointly announced the opening of an Expanded Access Program (EAP) for TFF VORI, enabling patients access to TFF VORI in the United States, Australia, United Kingdom, Canada and select countries in Europe. The EAP is meant to provide access to TFF VORI in patients who are not eligible for the ongoing clinical trial and who have limited or no other treatment options or who have had unfavorable response to adequate standard of care therapy including to oral or intravenous voriconazole.

 

 

 

 

Financial Results

 

For the quarter ended September 30, 2023, compared to quarter ended September 30, 2022

 

●Cash Position: as of September 30, 2023, TFF Pharmaceuticals reported cash and cash equivalents of $9.7 million. Based on the gross proceeds of 5.7 million dollars received from the financing transaction that closed on August 17, 2023, the Company expects its current cash runway to fund operations into the second quarter of 2024.

 

●Research and Development (R&D) expenses: R&D expenses for the third quarter of 2023 were $2.4 million, compared to $4.0 million for the comparable period in 2022. The $1.6 million decrease year-over-year is primarily a result of higher clinical and manufacturing expenses in the prior year period associated with the set-up of the TFF VORI and TFF TAC Phase 2 clinical trials.

 

●General & Administrative (G&A) expenses: G&A expenses for the third quarter of 2023 were $2.3 million, compared to $3.3 million for the comparable period in 2022. The $1.0 million decrease year-over-year is primarily related to decreased professional fees and patent expenses, insurance, consulting and market research, and payroll and related expenses.

 

●Net Loss: TFF Pharmaceuticals reported a net loss for the third quarter of 2023 of $4.4 million, compared to a net loss of $7.3 million for the comparable period in 2022.

 

Conference Call and Webcast Information

 

The Company will host a conference call today, Tuesday, November 14, 2023, at 4:30 PM Eastern Time, to discuss third quarter 2023 financial results and the corporate update. To participate in the conference call, please utilize the following information:

 

Domestic Dial-In Number: Toll-Free: 1-888-886-7786

 

International Dial-In Number: 1-416-764-8658

 

Conference ID: 08897681

 

Call me™: LINK (will be made active 15 minutes prior to the scheduled start time)

 

The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals’ Website, https://tffpharma.com or directly at https://viavid.webcasts.com/starthere.jsp?ei=1637201&tp_key=3b92c57ca8

 

The conference call will also be available for replay for one month on the Company’s website in the Events Calendar of the Investors section.

 

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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, the adequacy of the Company’s cash runway to meet its near-term funding needs, 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 working capital after giving effect to the recently announced public offering will not be sufficient to fund the Company’s working capital requirements through Q1 2024, (iii) 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, (iv) the risk that the Company may not be able to successfully conclude clinical testing of its TFF VORI or TFF TAC or obtain pre-market approval of any of its dry powder product candidates, (v) success in early phases of pre-clinical and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results, (vi) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (viii) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (ix) 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

 

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TFF PHARMACEUTICALS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2023   2022   2023   2022 
                 
Grant revenue  $234,763   $87,586   $619,543   $183,025 
Operating expenses:                    
Research and development   2,386,707    4,025,940    9,087,264    14,360,293 
General and administrative   2,268,656    3,342,266    8,058,235    10,238,744 
Total operating expenses   4,655,363    7,368,206    17,145,499    24,599,037 
                     
Loss from operations   (4,420,600)   (7,280,620)   (16,525,956)   (24,416,012)
                     
Other income (expense):                    
Interest income   88,810    6,119    160,009    19,184 
Change in fair value of note receivable   (77,454)   -    (114,870)   - 
Total other income, net   11,356    6,119    45,139    19,184 
                     
Net loss  $(4,409,244)  $(7,274,501)  $(16,480,817)  $(24,396,828)
                     
Net loss per share, basic and diluted  $(0.09)  $(0.29)  $(0.41)  $(0.96)
Weighted average common shares outstanding, basic and diluted   47,441,693    25,451,691    39,983,825    25,399,352 

 

4

 

 

TFF PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

   September 30,
2023		   December 31,
2022		 
   (Unaudited)     
         
ASSETS        
Current assets:        
Cash and cash equivalents  $9,725,755   $16,612,315 
Research and development tax incentive receivable   361,485    186,507 
Prepaid assets and other current assets   805,659    2,226,344 
Total current assets   10,892,899    19,025,166 
Operating lease right-of-use asset, net   139,230    196,044 
Property and equipment, net   2,064,354    3,078,342 
Note receivable - Augmenta   1,781,000    1,812,975 
Other assets   7,688    7,688 
Total assets  $14,885,171   $24,120,215 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
           
Current liabilities:          
Accounts payable  $983,287   $919,607 
Accrued compensation   -    4,430 
Deferred research grant revenue   76,000    126,000 
Current portion of operating lease liability   82,725    80,625 
Total current liabilities   1,142,012    1,130,662 
Operating lease liability, net of current portion   52,230    110,094 
Total liabilities   1,194,242    1,240,756 
           
Commitments and contingencies          
           
Stockholders’ equity:          
Common stock   59,134    36,193 
Additional paid-in capital   127,404,746    120,070,983 
Accumulated other comprehensive loss   (203,712)   (139,295)
Accumulated deficit   (113,569,239)   (97,088,422)
Total stockholders’ equity   13,690,929    22,879,459 
Total liabilities and stockholders’ equity  $14,885,171   $24,120,215 

 

 

5

 

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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
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