Conference call and live webcast scheduled for
Thursday, March 26, 2020 at 4:30pm EDT
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
fourth quarter and full year ended December 31, 2019, as well as
provided a business update on recent corporate and clinical
developments. The Company will discuss the clinical, corporate and
financial highlights on a conference call and live webcast,
scheduled today, Thursday, March 26, 2020 at 4:30pm EDT.
“TFF Pharmaceuticals has made tremendous progress in a short
period of time as a public company,” said Glenn Mattes, President
and CEO of TFF Pharmaceuticals. “We’ve achieved important early
milestones in our Phase 1 clinical trial of our Voriconazole
Inhalation Powder, to treat the severe and life-threatening disease
of Invasive Pulmonary Aspergillosis, or IPA. This is the first
clinical study ever in healthy subjects of a direct-to-lung, Thin
Film Freezing (TFF) dry-powder formulation.
“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, Thursday, March
26, 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:
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 in Australia 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
the University 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 to Defense 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 to
DARPA and DARPA may, or may not, award the Company this contract.
Should DARPA 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
with Torreya Partners as its strategic advisor for the countries of
China and South Korea. Torreya will lead the partnering efforts in
these countries. Subsequently, on March 12, 2020, the Company
announced its engagement with J.S. Cole and Associates to act as
the Company’s strategic advisor in Japan. 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 December 31, 2019, compared to
2018
- 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 December 31, 2019, compared to the
prior year
- 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 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 39 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 and the Company’s plans to add to its existing pipeline
of product candidates. 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) no drug product incorporating the TFF platform has received FDA
pre-market approval or otherwise been incorporated into a
commercial drug product, (ii) 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
(iii) 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 STATEMENTS
OF OPERATIONS
Three Months Ended December
31, 2019
Three Months Ended December
31, 2018
Twelve Months Ended December
31, 2019
January 24, 2018 to December
31, 2018
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
TFF PHARMACEUTICALS,
INC.
CONDENSED BALANCE
SHEETS
As of December 31,
2019
As of December 31,
2018
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, $0.001 par
value, 10,000,000 shares authorized; 0 and 5,662,000 shares issued
and outstanding as of December 31, 2019 and 2018 respectively
__
12,485,971
Stockholders’ Equity (Deficit):
Common stock, $0.001 par value, 45,000,000
shares authorized; 18,450,992 and 4,000,000 shares issued and
outstanding as of December 31, 2019 and 2018, respectively
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: Glenn Mattes President and CEO TFF
Pharmaceuticals, Inc gmattes@tffpharma.com 737-802-1973
Kirk Coleman Chief Financial Officer TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com 817-989-6358
Investor Relations and Media: Paul Sagan
LaVoieHealthScience psagan@lavoiehealthscience.com 617-953-4779
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