Conference call and live webcast scheduled for
“TFF Pharmaceuticals has made tremendous progress in a short period of time as a public company,” said
“Our groundbreaking TFF technology continues to garner considerable attention from potential industry partners, as well as governmental agencies,” continued Mattes. “And, due to its capabilities to potentially mitigate the need for cold chain storage and distribution of vaccines, interest from some of the largest developers of vaccines and anti-virals, as well. We feel we have untapped potential in this technology and are eager to further advance it for drugs for chronic respiratory diseases and lung conditions, as well as new chemical entities and existing therapies for a multitude of indications.”
Conference Call and Webcast Information
The Company will host a conference call today,
Domestic Dial-In Number: Toll-Free: (800) 816-3024
International Dial-In Number (857) 770-0106
Conference ID: 7695599
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/k9qym597. 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 Clinical and Corporate Highlights:
- Voriconazole Inhalation Powder: At the end of 2019, TFF’s lead clinical program, Voriconazole Inhalation Powder, to treat the severe and life-threatening disease of Invasive Pulmonary Aspergillosis, or IPA, began dosing subjects in its Phase 1 clinical trial. To date, the Company has successfully completed all four dosing cohorts in the single ascending dose (SAD) phase of the trial, ahead of anticipated schedule. Enrollment of the first cohort in the multiple ascending dose (MAD) portion of the study has also been completed. The Data Safety Monitoring Board (DSMB) has approved escalation to the next dose level. The Company anticipates a Phase I study database lock by the end of Q2-2020, with 6-month toxicology studies complete by the end of Q4-2020.
-
Tacrolimus Inhalation Powder: TFF’s second clinical program, Tacrolimus Inhalation Powder, is an inhaled dry powder version of tacrolimus, one of the most commonly administered immunosuppressive drug used in solid organ transplants. The Company intended to begin Single Ascending Dose Phase I studies by the end of Q1-2020 in
Australia , with Multiple Ascending Dose studies beginning in Q2-2020. However, with the spread of COVID-19 across the continent, the Company’s CRO partner informed us there would be a delay in initiating the trial. We are currently monitoring the situation inAustralia and are closely looking into alternative trial sites.
-
Strategic Business Development and Partnership Activities – Commercial Pharma and Biopharmaceutical companies: In
December 2019 ,TFF Pharmaceuticals entered into a feasibility agreement with theUniversity of Texas at Austin (UT-Austin ) and an undisclosed leading worldwide biopharmaceutical company (“Partner No. 1”), to explore using the Company’s Thin Film Freezing technology platform to formulate, perform testing on and collaborate on optimization work for two proprietary compounds of Partner No.1. This work is ongoing.TFF is collaborating with a large multi-national pharma company (“Partner No. 2”) and UT-
Austin to explore using the Company’s Thin Film Freezing technology platform to formulate a liquid vaccine product candidate of Partner No. 2 into a dry powder formulation for reconstitution. The Company, with the assistance of UT-Austin , has successfully taken the partner’s vaccine, which contains an aluminum adjuvant, and formulated it using the Company’s Thin Film Freezing technology. The Company has performed internal testing and the TFF reconstituted dry powder has the same properties as the initial liquid vaccine. The TFF dry powder vaccine has been delivered to Partner No. 2 for internal testing, which includes animal testing, and such testing has confirmed that the TFF dry powder formulation meets the same specifications as the liquid vaccine currently in development. Ongoing formulation optimization and additional testing is underway.TFF continues to engage with several leading multi-national pharma companies in an effort to enter into feasibility projects taking the partner’s product candidates, whether small molecule, large molecule, biologics, enzymes, antibodies, gene therapy, DNA derived therapy and/or vaccines, to utilize the Company’s Thin Film Freezing technology platform to deliver new and innovative products directly to the lung.
-
Potential mRNA Product Candidates: The Company is applying its Thin Film Freezing platform technology to advanced delivery systems that incorporate siRNA, mRNA and DNA delivery, by leveraging its unique ability to convert liquid forms that are injected into stable dry powder forms that can be delivered by needle-free means such as inhalation and intranasally, as well as reconstituted into a liquid form for reconstitution. TFF, working in collaboration with UT
Austin , has performed initial proof of concept work utilizing the Company’s TFF technology in order to successfully formulate mRNA into a dry powder. The TFF generated mRNA dry powder has favorable aerosol properties which allows for the delivery of mRNA directly to the lung via oral inhalation in an effort to treat certain debilitating pulmonary diseases. This preliminary proof of concept work is ongoing. Simultaneously, TFF continues to engage in exploratory discussions with multiple potential partners in a focused effort to collaborate in performing feasibility work on the partner’s proprietary mRNA respiratory product candidates using the Company’s TFF technology.
-
Strategic Business Development and Partnership Activities – Governmental and Defense Contracting Agencies: TFF continues to engage with a number of government and defense contracting agencies in an effort to utilize the Company’s Thin Film Freezing technology platform to formulate dry powder vaccines for delivery via reconstitution or lung inhalation or nasal inhalation. The Company’s testing confirms that Thin Film Freezing maintains the vaccine’s particle size distribution and immunogenicity, is robust for extended periods at room temperature, withstands unintentional freezing, and can be stored and shipped free of cold-chain handling, displays extended stability for stockpiling – dry powder storage over liquid, and provides for needle-free vaccination (nasal or inhalation administration). The Company continues its ongoing discussions with each of these government agencies in an effort to partner its TFF technology and obtain development funding.
On
February 20, 2020 , the Company, along with its potential partner, submitted a proposal toDefense Advanced Research Projects Agency (DARPA) through the Broad Agency Announcement (BAA) process for the Personalized Protective Biosystem (PPB) program. The Company expects to be notified of the award, if an award is granted, within 60 to 90 days after the date of submission. Should the Company be awarded this contract, the Company shall utilize its TFF technology to develop dry powder formulations of the countermeasures for inhalation delivery to the lung using a dry powder inhaler device, develop powder formulations of the countermeasures for ocular delivery as a liquid using a dropper, and develop powder formulations of the countermeasures for dermal delivery as a cream. Company submitted this proposal toDARPA andDARPA may, or may not, award the Company this contract. ShouldDARPA award the Company this contract,DARPA would fund all activities contained in the awarded contract.
- CBD Development Studies: The Company is also engaged in the development of a dry powder formulation of cannabidiol, or CBD, which has been reported to be used by some for the treatment of various epilepsy syndromes as well as anxiety, insomnia, and different types of pain. We are in the early stages of developing an inhaled dry powder form of CBD that could be used to support or to treat a variety of health issues that may benefit from CBD administration. We are also actively engaged in discussions with several third parties concerning our grant of a license to our TFF technology platform in the field of use of CBD.
- COVID-19/ SARS-CoV-2 Feasibility Projects: TFF is performing an exhaustive exercise reviewing all previously FDA approved drugs that may be repurposed in an effort to combat the novel coronavirus behind the COVID-19 pandemic outbreak. The Company is reviewing libraries of compounds that would 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 endemic coronaviruses. Simultaneously, the Company is in discussions with multiple potential partners that have treatments in development that target SARS-CoV-2. These discussions focus on the key differentiating characteristics of the TFF technology in treating this respiratory disease such as quick onset of action, better absorption, lower dose, better safety profile, less systemic absorption, improved stability, ease of use, and direct delivery of the compound to the lung.
-
Strategic Business Development and Partnership Activities – Ex-US Opportunities: The Company is executing on its strategy to expand it partnerships into other regions of the world. Recently, on
March 9, 2020 , the Company announced its engagement withTorreya Partners as its strategic advisor for the countries ofChina andSouth Korea . Torreya will lead the partnering efforts in these countries. Subsequently, onMarch 12, 2020 , the Company announced its engagement withJ.S. Cole and Associates to act as the Company’s strategic advisor inJapan . The Company continues to evaluate other potential regions of the world in an effort to partner its lead product candidates and innovative technology.
Financial Results
For the year ended
-
Cash Position: As of
December 31, 2019 , TFF Pharmaceutics reported cash and cash equivalents of$28.1 million . -
Research and Development (R&D) expenses: R&D expenses for 2019 were
$8.8 million , compared to$849,000 in 2018. -
General & Administrative (G&A) expenses: G&A expenses for 2019 were
$3,165,000 , compared to$3,049,000 in 2018. -
Net Loss:
TFF Pharmaceuticals reported a net loss for 2019 of$11.87 million , compared to a net loss of$3.84 million in 2018.
For the three months ended
-
Research and Development (R&D) expenses: R&D expenses for the fourth quarter of 2019 were
$3.3 million , compared to$89,000 for the same period in 2018. -
General & Administrative (G&A) expenses: G&A expenses for the fourth quarter of 2019 were
$1.4 million , compared to$806,000 for the same period of 2018. -
Net Loss:
TFF Pharmaceuticals reported a net loss for the fourth quarter of 2019 of$4.7 million , compared to a net loss of$872,000 for the same period of 2018.
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 STATEMENTS OF OPERATIONS |
||||||||||||||
|
Three Months |
|
|
Three Months |
|
|
Twelve Months |
|
|
|||||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
3,268,180 |
|
$ |
89,454 |
|
|
$ |
8,822,226 |
|
|
$ |
848,809 |
|
General and administrative |
|
1,443,640 |
|
|
805,549 |
|
|
|
3,165,331 |
|
|
|
3,049,337 |
|
Total operating expenses |
|
4,711,820 |
|
|
895,003 |
|
|
|
11,987,557 |
|
|
|
3,898,146 |
|
Loss from operations |
|
(4,711,820 |
) |
|
(895,003 |
) |
|
|
(11,987,557 |
) |
|
|
(3,898,146 |
) |
Other income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
49,630 |
|
|
22,692 |
|
|
|
117,329 |
|
|
|
55,960 |
|
Total other income |
|
49,630 |
|
|
22,692 |
|
|
|
117,329 |
|
|
|
55,960 |
|
Net loss |
|
(4,662,190 |
) |
|
(872,311 |
) |
|
|
(11,870,228 |
) |
|
|
(3,842,186 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividend |
|
(106,483 |
) |
|
(222,834 |
) |
|
|
(875,359 |
) |
|
|
(728,350 |
) |
Deemed dividend for beneficial conversion feature of Series A Preferred Stock |
$ |
(23,929,751) |
|
$ |
____ |
|
|
$ |
(23,929,751 |
) |
|
$ |
____ |
|
Net loss applicable to common stock per share, basic and diluted |
$ |
(2.00 |
) |
$ |
(0.25 |
) |
|
$ |
(5.31 |
) |
|
$ |
(1.31 |
) |
Weighted average common shares outstanding, basic and diluted |
|
14,338,249 |
|
|
4,400,000 |
|
|
|
6,904,983 |
|
|
|
3,483,836 |
CONDENSED BALANCE SHEETS |
||||||||
|
|
As of |
|
As of |
|
|||
Assets |
|
|
(Unaudited) |
|
|
|
(Unaudited) |
|
Current Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
28,094,936 |
|
|
$ |
10,261,671 |
|
Prepaid assets and other current assets |
|
|
1,092,462 |
|
|
|
12,065 |
|
Total Current Assets |
|
|
29,187,398 |
|
|
|
10,273,736 |
|
Deferred Offering Costs |
|
|
__ |
|
|
|
127,768 |
|
Total Assets |
|
$ |
29,187,398 |
|
|
$ |
10,401,504 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Deficit |
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
410,638 |
|
|
$ |
428,645 |
|
Accrued dividends payable |
|
|
__ |
|
|
|
728,350 |
|
Total Current Liabilities |
|
|
410,638 |
|
|
|
1,156,995 |
|
|
|
|
|
|
|
|
|
|
Accrued research and development expense |
|
|
1,132,013 |
|
|
|
__ |
|
Total Liabilities |
|
|
1,542,651 |
|
|
|
1,156,995 |
|
|
|
|
|
|
|
|
|
|
Series A Preferred Stock |
|
|
|
|
|
|
|
|
Series A Preferred Stock, |
|
|
__ |
|
|
|
12,485,971 |
|
Stockholders’ Equity (Deficit): |
|
|
|
|
|
|
|
|
Common stock, |
|
|
18,451 |
|
|
|
4,000 |
|
Additional paid-in capital |
|
|
43,338,710 |
|
|
|
596,724 |
|
Accumulated deficit |
|
|
(15,712,414 |
) |
|
|
(3,842,186) |
) |
Total Stockholders’ Equity (Deficit) |
|
|
27,644,747 |
|
|
|
(3,241,462) |
) |
|
|
|
|
|
|
|
|
|
Total Liabilities, Series A Preferred Stock and Stockholders’ Equity (Deficit) |
|
$ |
29,187,398 |
|
|
$ |
10,401,504 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200326005641/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: