Enters into worldwide license agreement with UNION Therapeutics for its Thin Film Freezing technology in combination with niclosamide
Closes on
Completes Phase 1 trial dosing for Voriconazole Inhalation Powder and begins Phase 1 trial for Tacrolimus Inhalation Powder
Conference call and live webcast scheduled for
“TFF Pharmaceutical’s accomplishments during the quarter, and in recent weeks, have truly demonstrated the capability and potential of our groundbreaking technology platform,” said
“The recognition of the significance of our platform is further evidenced by our highly successful
“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.
“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,
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:
-
Worldwide Licensing Agreement with UNION Therapeutics: On
August 12, 2020 , the Company announced a worldwide exclusive licensing agreement with UNION Therapeutics (UNION) for its Thin Film Freezing technology used in combination with niclosamide. UNION Therapeutics will acquire an option to obtain a worldwide exclusive license of TFF Pharmaceuticals Thin Film Freezing technology to be used in combination with oral and inhalation versions of niclosamide, potentially for COVID-19 as well as other therapies, and for its use in other UNION developed salts, derivatives and structurally related compounds.
-
Private Financing Round: On
August 11, 2020 , the Company entered into a definitive agreement with a syndicate of high quality healthcare investors for the private placement of up to$25,913,550 , before deducting placement agent and other offering expenses, of common shares of the Company. The placement closed onAugust 13 th. Net proceeds from the financing will be used to accelerate the expansion of the company’s internal development portfolio beyond its programs for Voriconazole and Tacrolimus inhalation powders.
- Voriconazole Inhalation Powder: TFF’s lead clinical program, Voriconazole Inhalation Powder, to treat the severe and life-threatening disease of Invasive Pulmonary Aspergillosis, or IPA, successfully completed the clinical portion of its Phase 1 trial with both Single Ascending Dose and Multiple Ascending Dose phases with 32 healthy subjects enrolled in each to evaluate the safety, tolerability and pharmacokinetic profile of Voriconazole Inhalation Powder. Initial topline results indicate that repeated doses of up to 80 mg/dose twice daily for 7-days in healthy normal volunteers were well tolerated.
-
Tacrolimus Inhalation Powder: TFF’s second clinical program, Tacrolimus Inhalation Powder, began Phase I trials. This single ascending dose (SAD) and multiple ascending dose (MAD) study will assess the safety, tolerability and pharmacokinetic profile of the Tacrolimus Inhalation Powder in healthy subjects. Tacrolimus is an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection. Subjects were successfully enrolled and dosed at a single site in
Australia under the Australian CTN process, despite the clinical trial challenges posed by the COVID-19 pandemic.In June, the
U.S. Food and Drug Administration (FDA) granted orphan drug designation to Tacrolimus Inhalation Powder for prophylaxis of lung allograft rejection.
-
COVID-19/SARS-CoV-2 Drug Repurposing Feasibility Projects: TFF is actively reviewing previously FDA approved drugs that may be repurposed to combat the novel coronavirus behind the COVID-19 pandemic outbreak. The Company is reviewing libraries of compounds that could potentially benefit from the characteristics of the TFF technology in developing a dry powder product delivered directly to the lung that is capable of targeting SARS-CoV-2 and potentially similar viruses such as SARS-CoV, MERS-CoV and other endemic coronaviruses.
During the quarter, the Company and the inventor of its TFF technology, Dr.
Robert O. (Bill) Williams III , continued to evaluate the existing antiviral drug, niclosamide, to enhance its effect as a potential COVID-19 therapy. Niclosamide is an FDA-approved oral anthelminthic drug that we believe has the potential to be repurposed to treat a variety of viral infections, such as severe acute respiratory syndrome coronavirus (SARS-CoV),Middle East respiratory syndrome coronavirus (MERS-CoV), Zika virus (ZIKV), and others. Our Thin Film Freezing technology will be evaluated by UNION therapeutics to develop an inhaled form of niclosamide that could potentially enhance this promising drug’s bioavailability for treating respiratory modes of infection. If successful, UNION therapeutics orTFF Pharmaceuticals , depending on whether Union exercises its option, would potentially progress to filing an IND for this compound with the FDA.Also, after the end of the quarter,
Dr. Williams presented initial results of research evaluating the re-formulation of remdesivir to a dry powder form for COVID-19 antiviral treatment for inhalation using the Company’s Thin Film Freezing technology. Dr. Williams’ research team at theUniversity of Texas at Austin’sDivision of Molecular Pharmaceutics and Drug Delivery developed inhaled forms of remdesivir for protecting and treating the respiratory mode of infection, including an amorphous brittle matrix powder made by Thin Film Freezing.
Financial Results
For the six months ended
-
Research and Development (R&D) expenses: R&D expenses for the six months ended
June 30, 2020 were$4.80 million , compared to$2.99 million for the same period in 2019. -
General & Administrative (G&A) expenses: G&A expenses for the six months ended
June 30, 2020 were$2.89 million , compared to$1.42 million for the same period of 2019. -
Net Loss:
TFF Pharmaceuticals reported a net loss for the six months endedJune 30, 2020 of$7.61 million , compared to a net loss of$4.37 million for the same period of 2019. -
Shares Outstanding: Weighted average common shares outstanding, basic and diluted, for the six months ended
June 30, 2020 were 19,040,134, compared with 4,400,000 for the same period in 2019.
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
SAFE HARBOR
This press release contains forward-looking statements regarding
|
||||||||||||||||
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
||||||||||||||||
|
|
Three Months |
|
Three Months |
|
Six Months |
|
Six Months |
||||||||
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 |
|
|
||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
|
|
|
|
|
||||
|
|
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; |
|
|
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 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200813005734/en/
Company:
gmattes@tffpharma.com
737-802-1973
kcoleman@tffpharma.com
817-989-6358
Investor Relations and Media:
psagan@lavoiehealthscience.com
617-953-4779
Source: