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Classified in: Health, Science and technology, Business, Covid-19 virus
Subjects: EARNINGS, Conference Call, Webcast

TFF Pharmaceuticals Reports Second Quarter 2020 Financial and Business Results


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 reported financial results for the first quarter ended June 30, 2020, as well as provided a business update on recent corporate and clinical developments. The Company will discuss its clinical, corporate and financial highlights on a conference call and live webcast, scheduled today, Thursday, August 13, 2020 at 4:30pm EDT.

"TFF Pharmaceutical's accomplishments during the quarter, and in recent weeks, have truly demonstrated the capability and potential of our groundbreaking technology platform," said Glenn Mattes, President and CEO of TFF Pharmaceuticals. "Most recently, our worldwide licensing agreement with UNION Therapeutics on our Thin Film Freezing technology for oral and inhalation versions of niclosamide has the potential to speed efforts to reformulate and investigate this very promising existing drug for COVID-19 therapies. It is gratifying to have our technology recognized by a company that has years of experience in working with niclosamide in a variety of therapeutic areas."

"The recognition of the significance of our platform is further evidenced by our highly successful $25.9 million financing, completed on August 13, supported by a number of leading life science investment firms. These funds will be used to advance our clinical programs, the continued research and development of inhalable drug products, vaccines, biologics and botanicals and furthering ongoing business development and partnering initiatives."

"Our lead clinical program, Voriconazole Inhalation Powder, the first clinical study ever in healthy subjects of a direct-to-lung, dry-powder formulation for the treatment of Invasive Pulmonary Aspergillosis (IPA) successfully completed Phase 1 dosing, with initial indications that doses of up to two times higher than those reported to be efficacious in the treatment of IPA appeared to be safe."

"We also began our second clinical trial program with the Phase 1 dosing of healthy subjects of Tacrolimus Inhalation Powder, an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection," said Mattes. "This trial has successfully started despite a challenging clinical trial environment due to the COVID-19 pandemic."

"And this quarter, we continue to see the broad capabilities of our platform to reformulate existing drugs into inhalation forms that may prove to be more effective," said Mattes. "The inventor of our TFF technology, Dr. Robert O. (Bill) Williams III, demonstrated recently the ability to effectively reformulate remdesivir, one of the most important new COVID-19 therapeutics, into a dry powder form that could dramatically enhance its treatment options."

"In a time of extraordinary need, we are very proud that our scientists, clinicians and collaborators have worked so diligently to help fulfill the promise of our technology and platform," said Mattes. "This is ultimately what we envisioned when we began this Company, to be able to rapidly investigate, prototype and develop a wide variety of compounds using our technology for better efficacy and effect. We look forward to continued progress in these efforts in the quarters to come," concluded Mattes.

Conference Call and Webcast Information

The Company will host a conference call today, Thursday, August 13, 2020, at 4:30 pm, Eastern Daylight Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

U.S. Dial-In Number: Toll-Free: (800) 816-3024
International Dial-In Number (857) 770-0106
Conference ID: 7516247

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://edge.media-server.com/mmc/p/28vdaqxx. Please access the Company's website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software. 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.

Recent Corporate and Clinical Highlights:

Financial Results

For the six months ended June 30, 2020, compared to the prior year

About TFF Pharmaceuticals' Thin Film Freezing technology platform

TFF Pharmaceuticals' Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a "Brittle Matrix Particle," which possesses low bulk density, high surface area, and typically an amorphous morphology. allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.

About TFF Pharmaceuticals

TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 42 patents issued or pending in the US 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 benefits of the Company's TFF platform and its dry powder versions of Voriconazole and Tacrolimus, the potential license of our technology to UNION therapeutics and the Company's plans to add to its existing pipeline of product candidates and license its technology to other third-parties. 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 UNION will not exercise its option and that the collaboration will go no further than the investigator lead studies, (ii) if UNION does exercise its option to license TFF's technologies, the risk that UNION will not pursue the development of a product candidate under the license with TFF or, if it does, that such product candidate will obtain regulatory approval or commercial success, (iii) the risk that few, or none, of the conditions for the milestone or sales-based payment will be satisfied and TFF will receive little, or none, of such milestone and sales-based payments, (iv) the fact that 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 2019 Annual Report on Form 10-K filed with the SEC on March 26, 2020. 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.

TFF PHARMACEUTICALS, INC.

 

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

 

 

 

Three Months
Ended
June 30,
2020

 

Three Months
Ended
June 30,
2019

 

Six Months
Ended
June 30,
2020

 

Six Months
Ended
June 30,
2019

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

2,567,771

 

 

$

1,319,656

 

 

$

4,803,313

 

 

$

2,990,518

 

General and administrative

 

 

1,274,803

 

 

 

889,453

 

 

 

2,892,727

 

 

 

1,421,051

 

Total operating expenses

 

 

3,842,574

 

 

 

2,209,109

 

 

 

7,696,040

 

 

 

4,411,569

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(3,842,574

)

 

 

(2,209,109

)

 

 

(7,696,040

)

 

 

(4,411,569

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

25,995

 

 

 

22,189

 

 

 

82,263

 

 

 

41,834

 

Total other income

 

 

25,995

 

 

 

22,189

 

 

 

82,263

 

 

 

41,834

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

(3,816,579

)

 

 

(2,186,920

)

 

 

(7,613,777

)

 

 

(4,369,735

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred stock dividend

 

 

?

 

 

 

(288,962

)

 

 

?

 

 

 

(510,240

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss applicable to common stock

 

 

(3,816,579

)

 

 

(2,475,882

)

 

 

(7,613,777

)

 

 

(4,879,975

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

(19,208

)

 

 

?

 

 

 

(39,491

)

 

 

?

 

Comprehensive loss

 

 

(3,835,787

)

 

 

(2,475,882

)

 

 

(7,653,268

)

 

 

(4,879,975

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss applicable to common stock per share, basic and diluted

 

$

(0.20

)

 

$

(0.56

)

 

$

(0.40

)

 

$

(1.11

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding, basic and diluted

 

 

19,071,658

 

 

 

4,400,000

 

 

 

19,040,134

 

 

 

4,400,000

 

TFF PHARMACEUTICALS, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

 

 

June 30,

 

December 31,

 

 

2020

 

2019

 

 

(Unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

21,924,119

 

 

$

28,094,936

 

Prepaid assets and other current assets

 

 

610,376

 

 

 

1,092,462

 

 

 

 

 

 

 

 

 

 

Total assets

 

$

22,534,495

 

 

$

29,187,398

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

689,803

 

 

$

410,638

 

 

 

 

 

 

 

 

 

 

Total current liabilities

 

 

689,803

 

 

 

410,638

 

 

 

 

 

 

 

 

 

 

Accrued research and development expense (see Note 5)

 

 

?

 

 

 

1,132,013

 

 

 

 

 

 

 

 

 

 

Total liabilities

 

 

689,803

 

 

 

1,542,651

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies (see Note 4)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Common stock; $0.001 par value, 45,000,000 shares authorized; 18,671,658 and 18,450,992 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively

 

 

18,672

 

 

 

18,451

 

Additional paid-in capital

 

 

45,191,702

 

 

 

43,338,710

 

Accumulated other comprehensive loss

 

 

(39,491

)

 

 

?

 

Accumulated deficit

 

 

(23,326,191

)

 

 

(15,712,414

)

 

 

 

 

 

 

 

 

 

Total stockholders' equity

 

 

21,844,692

 

 

 

27,644,747

 

 

 

 

 

 

 

 

 

 

Total liabilities and stockholders' equity

 

$

22,534,495

 

 

$

29,187,398

 

 


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