Reports positive Phase 1 study results for
Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder
Awarded subcontract license by U.S. government
agency to formulate biologic countermeasures to be used by the U.S.
military
Announces feasibility agreements with
Greenlight Biosciences for Covid-19 mRNA Vaccine Reformulation and
NeuroRx for Covid-19 therapeutic for critically ill patients
Conference call and live webcast scheduled
today, Wednesday, March 10, 2021 at 4:30pm EST
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, 2020, 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, Wednesday, March 10, 2021 at 4:30pm EST.
“2020 was a remarkable year of accomplishment and building
momentum for TFF Pharmaceuticals, due to success in achieving key
milestones in our two-pronged business model of internal
development of high-value, high-need therapeutics, combined with a
focused and aggressive approach to seek out partners, licensees and
collaborators for our breakthrough Thin Film Freezing platform
technology,” said Glenn Mattes, President and CEO of TFF
Pharmaceuticals.
“Our internal development programs are progressing ahead of
expectations, as we are seeing very positive clinical results in
both Phase 1 trials for our Voriconazole Inhalation Powder program,
to treat the severe and life-threatening disease of Invasive
Pulmonary Aspergillosis, as well as for our Tacrolimus dry-powder
program for the prevention of lung transplant rejection.”
“Final data for our Voriconazole product, the first-ever
clinical study of a direct-to-lung, Thin Film Freezing (TFF)
dry-powder formulation, resulted in blood levels greater than
two-fold higher than those shown to clear complex IPA infections,
with no significant adverse events,” said Mattes. “And our
Tacrolimus product was able to reach therapeutic blood levels of
5-16 ng/mL in all patients from a single inhaled dose of 5 mg of
our reformulated Inhalation Powder, without significant adverse
events. Both these very significant results bode well for our
upcoming pivotal trials for these drugs, which address large
markets with unmet needs.”
“We are also honored to announce today a strategically important
contract for the Company with a major government research agency to
formulate dry powder versions of a suite of biological
countermeasures that is intended for use by our nation’s military
forces,” continued Mattes. “This is another meaningful event for
TFF as we continue to build our portfolio of development agreements
with pharmaceutical companies, the government and academia. We look
forward to providing more details on this contract pending security
review and approval of further news distribution from the
government and the prime contractor.”
“And our ubiquitous and disruptive Thin Film Freezing technology
continues to garner considerable attention from potential industry
partners,” said Mattes. “With the potential to mitigate the need
for cold chain storage and distribution of vaccines, as well as the
first-of-its-kind capability to reformulate large, complex biologic
molecules, thin film freezing has generated strong interest from
biotechnology companies, as well as some of the largest developers
of vaccines and anti-virals.”
“This is evident by the recent feasibility collaborations by
GreenLight Biosciences, a pioneering mRNA company, to reformulate
their mRNA Covid-19 vaccine candidate, and by NeuroRx, to
reformulate their product candidate, ZYESAMI, a therapeutic for
seriously ill Covid-19 patients,” said Mattes. “The interest from
these two companies, among many others, demonstrates the growing
recognition that our technology can dramatically advance potential
vaccines and therapeutics.”
“Our progress this year has firmly solidified the enormous
potential on our Thin Film Freezing technology to the vaccine,
biotechnology and drug development communities,” concluded Mattes.
“The breakthrough and disruptive capabilities of our platform
technology, and our ability to leverage this across both internal
development programs and external business development
opportunities has helped expand the depth of our business and will
continue to fuel our future growth.”
Conference Call and Webcast Information
The Company will host a conference call today, Wednesday, March
10, 2021, at 4:30 pm, Eastern Standard 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: (877)
784-1702 International Dial-In Number (857) 770-0110 Conference ID:
9195779
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/ev6cv5ub .
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 In March 2021, we
announced the successful completion of the Phase 1 clinical trial
and final data for Voriconazole Inhalation Powder for the treatment
of invasive pulmonary aspergillosis (IPA), an inhaled dry powder
version of voriconazole. Through completion of the Single Ascending
Dose (SAD) and Multiple Ascending Dose (MAD) cohorts, TFF
demonstrated that doses of 10, 20, 40, and 80 mg could be delivered
twice daily using a dry powder inhaler device with no significant
adverse events. There was no evidence of treatment-related or
dose-related trends in the reporting of treatment emergent adverse
events, throughout the study. No subjects experienced any dose
limiting toxicity events during the study. Evaluation of the
pharmacokinetic profile of the Voriconazole Inhalation Powder
demonstrated that mean peak plasma voriconazole levels reached
concentrations of 227 ng/mL following repeated dosing at 80 mg
twice daily for 7 days, without any reports of significant adverse
events. Based on the results of the Phase 1 trial, the Company will
study the 80 mg dose of Voriconazole Inhalation Powder for the
upcoming pivotal trial where it will be compared to the oral form
of voriconazole.
- Tacrolimus Inhalation Powder: In March 2021, we also
announced the successful dosing completion in the Single Ascending
Dose portion of the Phase 1 study of Tacrolimus Inhalation Powder
and that the Multiple Ascending Dose portion is progressing. The
SAD portion of the study indicated that TFF’s Tacrolimus Inhalation
Powder was able to reach therapeutic blood levels of 5-16 ng/mL in
all patients from a single inhaled dose of 5 mg of Tacrolimus
Inhalation Powder, without significant adverse events. The ability
to reach therapeutic blood levels efficiently, with low doses of
the inhaled powder, suggests that Tacrolimus Inhalation Powder may
have application beyond lung transplant, potentially in heart,
kidney and liver transplant patients.
- Strategic Business Development and Partnership Activities –
Governmental and defense contracting agencies: TFF has been
awarded a subcontract license by a U.S. government research agency
to formulate dry powder versions of biologic countermeasures
products to be used by the U.S. military. Our technology will be
used to develop topical, ophthalmic and inhaled products, and as a
result of this contract, TFF has been designated as an approved
subcontractor vendor, which will facilitate additional work with
the government. TFF will provide greater detail on the program
pending security review approvals of further news distribution from
the U.S. government and our prime contractor partner. In April of
2020, TFF Pharmaceuticals and USAMRIID, the U.S. Army’s premier
institution and facility for defensive research into
countermeasures against biological warfare, entered into a 3-year
Cooperative Research and Development Agreement (CRADA) to
investigate Thin Film Freeze Drying of various biodefense
countermeasures as needle-free, inhaled treatments that are
temperature-insensitive. The first two countermeasures, a
monoclonal antibody (mAbs) against Ebolavirus Zaire (EBOV) and a
recombinant vesicular stomatitis virus (rVSV) vaccine candidate
against Venezuelan equine encephalitis virus (VEEV), were TFFD
formulated and tested for efficacy in a well-established in vitro
neutralization assay. Data showed that the activity of the mAbs and
rVSV vaccines were preserved after TFFD. Formulation optimization
and long-term stability testing are ongoing and our next steps will
be in vivo testing in appropriate animal models. TFF continues to
engage and collaborate with various government and defense
contracting agencies in an effort to utilize the Company’s TFFD
technology platform to formulate dry powder vaccines and
therapeutics for delivery via reconstitution, or for lung or nasal
inhalation.
- Strategic Business Development and Partnership Activities –
Biopharmaceutical companies and research institutions: TFF
recently announced a feasibility and material transfer agreement to
evaluate a dry powder formulation of an early-stage Covid-19 mRNA
vaccine candidate for Greenlight Biosciences. The goal of this
feasibility work is to formulate and identify an optimal
formulation of the Greenlight Biosciences mRNA product candidate in
a dry powder form, which has superior stability as a dry powder,
maintains the particle size of the mRNA, maintains a high
encapsulation efficiency and has rapid reconstitution
characteristics for injection. TFF also entered into a feasibility
and material transfer agreement with NeuroRx to determine the
compatibility of NeuroRx’s ZYESAMI™ (aviptadil, previously
RLF-100™) as a dry powder formulation using TFF’s thin-film
freezing technology. TFF intends to formulate and identify an
optimal formulation of ZYESAMI in a dry powder form, with the goal
of providing superior aerosol properties for delivery directly to
the lungs. ZYESAMI is a recombinant form of a naturally occurring
peptide found in the lung called Vasoactive Intestinal Peptide
(VIP), which has been found to have potent
anti-inflammatory/anti-cytokine activity in animal models of
respiratory distress, acute lung injury, and inflammation. The
ability to deliver this drug directly to the lung via inhalation
could have important therapeutic implications and potentially
broaden the application of the drug to patients less severely
affected with Covid-19. In our worldwide licensing agreement with
UNION Therapeutics for thin film freezing technology used in
combination with niclosamide, our oral and powdered niclosamide
formulations are moving forward to first-in-human trials. Our
relationship with Felix Biotechnology is on track as we are working
with their lead bacteriophage product for inhalation delivery
directly to the lungs of patients. And our work with Augmenta
Bioworks is on track as well. Our partnered lead monoclonal
antibody product, targeting Covid-19 is scheduled to begin human
trials later this year. In April of 2020, TFF and the University of
Georgia’s Center for Vaccines and Immunology entered into a
research and development agreement to test the immunogenicity and
efficacy of universal influenza hemagglutinin (HA) recombinant
vaccines following the TFF process. In late 2020, we announced
positive preclinical immunogenicity and efficacy data from TFF
formulated UGA universal Influenza HA recombinant vaccines. Animals
were vaccinated with HA vaccines with or without adjuvants and
challenged with H1N1 and H3N2 influenza viruses. The TFF HA
vaccines elicited equivalent neutralizing antibodies and protection
against influenza virus infection compared to liquid formulations.
These results provide further evidence that Thin Film Freezing can
convert liquid forms of vaccines that require cold chain storage
into a much more stable dry powder form for ultimate use. 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.
- CBD Development and Commercialization: Our partner in
the cannabinoid space, PLUS Products, is now producing thin film
freezing formulations of cannabinoids and is planning to launch a
new product based on this technology toward the end of the second
quarter of 2021.
Financial Results
For the year ended December 31, 2020, compared to
2019
- Cash Position: As of December 31, 2020, TFF
Pharmaceuticals reported cash and cash equivalents of $35.3
million.
- Research and Development (R&D) expenses: R&D
expenses for 2020 were $10.7 million, compared to $8.8 million in
2019.
- General & Administrative (G&A) expenses: G&A
expenses for 2020 were $8.0 million, compared to $3.2 million in
2019.
- Net Loss: TFF Pharmaceuticals reported a net loss for
2020 of $18.6 million, compared to a net loss of $11.9 million in
2019.
For the three months ended December 31, 2020, compared to the
prior year
- Research and Development (R&D) expenses: R&D
expenses for the fourth quarter of 2020 were $3.1 million, compared
to $3.3 million for the same period in 2019.
- General & Administrative (G&A) expenses: G&A
expenses for the fourth quarter of 2020 were $2.9 million, compared
to $1.4 million for the same period of 2019.
- Net Loss: TFF Pharmaceuticals reported a net loss for
the fourth quarter of 2020 of $5.9 million, compared to a net loss
of $4.7 million for the same period of 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 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 Tacrolimus
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 various drugs, vaccines
and biologics 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) the risk that the Company may not be able to
successfully conclude clinical testing or obtain pre-market
approval of its dry powder versions of any drugs, vaccines or
biologics , (ii) no drug product incorporating the TFF platform has
received FDA pre-market approval or otherwise been incorporated
into a commercial drug product, (iii) the Company has no current
agreements or understandings with any large pharmaceutical
companies for the development of a drug product incorporating the
TFF Platform, (iv) the risk that the Company will not be able to
conclude a long-term commercial agreement with any third-party, and
(v) those other risks disclosed in the section “Risk Factors”
included in the Company’s 2020 Annual Report on Form 10-K filed
with the SEC on March 10, 2021. 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, 2020
Three Months Ended December
31, 2019
Year Ended December 31,
2020
Year Ended December 31,
2019
Operating expenses
Research and development
$
3,054,583
$
3,268,180
$
10,681,565
$
8,822,226
General and administrative
2,864,446
1,443,640
8,012,085
3,165,331
Total operating expenses
5,919,029
4,711,820
18,693,650
11,987,557
Loss from operations
(5,919,029
)
(4,711,820
)
(18,693,650
)
(11,987,557
)
Other income
Interest income
23,607
49,630
126,416
117,329
Total other income
23,607
49,630
126,416
117,329
Net loss
(5,895,422
)
(4,662,190
)
(18,567,234
)
(11,870,228
)
Preferred stock dividend
__
(106,483
)
__
(875,359
)
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
$
(0.26
)
$
(2.00
)
$
(0.91
)
$
(5.31
)
Weighted average common shares
outstanding, basic and diluted
22,759,329
14,338,249
20,425,162
6,904,983
TFF PHARMACEUTICALS,
INC.
CONDENSED BALANCE
SHEETS
As of December 31,
2020
As of December 31,
2019
Assets
(Unaudited)
(Unaudited)
Current Assets
Cash and cash equivalents
$
35,300,805
$
28,094,936
Prepaid assets and other current
assets
2,258,229
1,092,462
Total Current Assets
37,559,034
29,187,398
Property and equipment, net
1,102,808
__
Total Assets
$
38,661,842
$
29,187,398
Liabilities and Stockholders’
Equity
Current Liabilities
Accounts payable
$
1,297,725
$
410,638
Deferred research grant revenue
24,315
__
Total Current Liabilities
1,322,040
410,638
Accrued research and development
expense
__
1,132,013
Total Liabilities
1,322,040
1,542,651
Stockholders’ Equity:
Common stock, $0.001 par value, 45,000,000
shares authorized; 22,534,874 and 18,450,992 shares issued and
outstanding as of December 31, 2020 and 2019, respectively
22,535
18,451
Additional paid-in capital
71,648,453
43,338,710
Accumulated other comprehensive
loss
(51,538)
__
Accumulated deficit
(34,279,648
)
(15,712,414)
)
Total Stockholders’ Equity
37,339,802
27,644,747
)
Total Liabilities and Stockholders’
Equity
$
38,661,842
$
29,187,398
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210310005876/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 617-865-0041
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