Pivotal Trials to Begin in 2H-2021 for
Voriconazole Inhalation Powder for the Treatment of Invasive
Pulmonary Aspergillosis (IPA) and Tacrolimus Inhalation Powder for
Immunosuppression in Solid Organ Transplantation
Patent Filed for Once-a-Day Dosing for
Tacrolimus Inhalation Powder, Achieving Therapeutic Blood Levels
with a Single Low Dose
Science Day to be Held in June to Highlight
Thin Film Freezing Platform Technology
Conference Call and Live Webcast Scheduled
Today, Thursday, May 13, 2021, 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
first quarter ended March 31, 2021, 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, May
13, 2021, at 4:30pm EDT.
“We continue to make progress with our clinical development
programs: Voriconazole Inhalation Powder and Tacrolimus Inhalation
Powder,” said Glenn Mattes, President and CEO of TFF
Pharmaceuticals. “This progress, along with better-than-expected
clinical data, will allow us to initiate clinical trials designed
to achieve registration for both of these important programs by the
end of 2021.”
“The data we have seen from our Tacrolimus Inhalation Powder
trial suggests that we can achieve efficacious immunosuppressive
blood levels of tacrolimus with an inhaled, once-a-day, low-dose
formulation,” said Mattes. “We believe that inhaled tacrolimus’
ability to reduce the fluctuations of bioavailability offers a
compelling advantage over oral tacrolimus, as physicians often
attribute the peaks and troughs of oral delivery with suboptimal
efficacy and exacerbated side effects.”
“We have filed a US patent based on this once-a-day dosing
development, which could have major implications for lung
transplant patients, and potentially for heart, kidney and liver
transplant patients as well,” continued Mattes. “Based on our
recent research, we believe the peak yearly sales of tacrolimus in
all four indications could exceed $1 billion dollars.”
“This quarter, we’ve also made notable progress with a number of
our strategic partners,” said Mattes. “Our collaborations with
UNION therapeutics on niclosamide and Augmenta Bioworks on
monoclonal antibodies are progressing on plan, and our partner in
the cannabis space, PLUS Products, is seeing positive initial
manufacturing data and strong market interest.
“Also, our scientific collaboration partners at the University
of Texas at Austin generated meaningful new data that continues to
demonstrate the advantages of our Thin Film Freezing platform over
other competing technologies,” said Mattes. “This is true for both
small molecule therapeutic applications, as well as high molecular
weight biologics like proteins, including monoclonal antibodies,
messenger RNA, and plasmid DNA, where our technology offers the
only viable solution for dry powder reformulation.”
“To highlight these important scientific developments to as
broad an audience as possible, we are pleased to announce that the
Company will host a virtual Science Day in June,” said Mattes.
“This event will provide a scientific perspective on our Thin Film
Freezing platform technology from external scientific key opinion
leaders.”
“The growing portfolio of business development partnerships and
the pace of our clinical and scientific progress continued to be
impressive during the quarter,” concluded Mattes. “This remains a
testament to the outstanding efforts of our professionals, as well
as the continued recognition that our technology can have
game-changing consequences for the industry.”
Conference Call and Webcast Information
The Company will host a conference call today, Thursday, May 13,
2021, 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:
5777388
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/o4wvnbiv. 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, 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). 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.
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. TFF has completed dosing
in a GLP 13-week chronic toxicology study and has successfully
completed the first of two dosing cohorts in asthma patients to
evaluate safe dosing in patients with hyperreactive airways. There
have been no serious adverse events reported in these cohorts. The
Company is currently in active preparations for an end of Phase 1
meeting with the FDA, and we anticipate this meeting will be held
after the dosing in this Phase 1b asthma study is complete. We then
expect to initiate a pivotal clinical trial designed to demonstrate
efficacy for treating patients with IPA or for preventing infection
in patients at high risk for developing IPA infections.
- Tacrolimus Inhalation Powder: Enrollment in the final
cohort of our Phase 1 study is ongoing and is expected to be
completed shortly. Earlier in March, we announced the successful
completion of the single ascending dose (SAD) portion of the Phase
1 study of Tacrolimus Inhalation Powder. In the SAD phase of the
trial, we safely administered single doses of 0.5, 1.0, 2.5 and 5
mg to healthy normal volunteers. We had planned to dose an
additional cohort of subjects at 10 mg, but cancelled this cohort
after reaching efficacious dose levels below 10 mg. In the multiple
ascending dose (MAD) part of the study, we dosed subjects in cohort
1 and 2 with twice daily doses of 0.5 and 1.0 mg over 7 days. These
dose levels reached steady-state concentrations that are associated
with effective immunosuppression. Of particular note, we dosed
cohort-3 subjects with a single 1.5 mg dose each day for 7 days,
and these subjects were able to reach efficacious immunosuppressive
levels from once-a-day dosing with a low-dose concentration of
inhaled tacrolimus. We have also completed a GLP 26-week chronic
toxicology study that will be used to support registration, and we
remain on track to begin the pivotal trial work designed to
demonstrate efficacy of inhaled tacrolimus for the prevention of
lung allograft rejection. The enhanced bioavailability of inhaled
tacrolimus, coupled with its ability to bypass the gastrointestinal
tract, could also result in expanded therapeutic applications into
other solid organ transplants where significant drug-drug
interactions and food effects are a factor.
- Strategic Business Development and Partnership Activities –
Governmental and defense contracting agencies: In April, we
announced that Leidos, a Fortune 500 information technology,
engineering and science solutions and services leader, awarded the
Company a subcontract to participate in the Personalized Protective
Biosystems (PPB) Program to develop next-generation chemical and
biological protection for U.S warfighters and stability operators.
TFF Pharmaceuticals will utilize its Thin Film Freezing platform to
formulate a series of countermeasures designed to neutralize
chemical and biological agents at the site of vulnerable tissue
barriers, including the skin, eyes and respiratory system. We
continue to engage and collaborate with various government and
defense contracting agencies in an effort to utilize the Company’s
TFF technology platform to formulate dry powder vaccines and
therapeutics for delivery via reconstitution for lung or nasal
inhalation. This includes our 3-year Cooperative Research and
Development Agreement (CRADA) with the United States Army Medical
Research Institute of Infectious Diseases (USAMRIID) for biodefense
countermeasures, and our early-stage universal influenza work with
the University of Georgia’s Center for Vaccines and Immunology,
part of the NIH’s Collaborative Influenza Vaccine Innovation
Centers (CIVICs). Strategic Business Development and Partnership
Activities – Biopharmaceutical companies and research
institutions: Under 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. Recent
data from UNION suggests that niclosamide is effective against the
new prevalent British B.1.1.7 and South African B.1.351 COVID-19
variants. "We are pleased with our ongoing collaboration with TFF
Pharmaceuticals, and are happy to learn that the TFF niclosamide
program is advancing through development,” said Dr. Kim
Kjøller, Chief Executive
Officer of UNION therapeutics. “We share the desire to provide
much-needed therapeutics to COVID-19 stricken patients across the
patient continuum.” In a second COVID-related collaboration, the
worldwide joint venture between TFF and Augmenta Bioworks is now
well underway. This innovative, first-of-its kind program will seek
to apply our Thin Film Freezing technology to develop dry
powder-based monoclonal antibodies targeting COVID-19. "Our Joint
Collaboration with TFF is right on track,” said Christopher Emig,
Ph.D., CEO and Co-founder of Augmenta Bioworks, Inc. “We are making
great progress on our broadly neutralizing antibody therapy. We are
looking forward to the results of our IND enabling studies and
getting this much-needed therapeutic into the clinic as quickly as
possible. Combining Augmenta's discovery capabilities with TFF's
formulation and drug development expertise has been an incredibly
fruitful partnership." Cannabis Development and
Commercialization: Our partner in the cannabis space, PLUS
Products, has been producing thin film freezing formulations of
cannabis and is planning to launch a new product based on this
technology. “The results on the preliminary manufacturing runs with
the TFF technology have been even better than we had hoped,” said
Jake Heimark, CEO & Co-founder of PLUS Products. “And the
concept research on dry powder inhalation with the retail
distribution channels in California has created a high level of
interest in the product category.” Public Offering: As
announced previously on March 26, 2021, the Company closed on an
underwritten offering of 2,140,000 shares of its common stock.
Proceeds from the offering totaled approximately $30,000,000,
before deducting underwriting discounts and other offering
expenses. At the end of the quarter, with the net proceeds from
this offering, the Company’s liquidity included approximately $58.1
million in cash and cash equivalents.
Financial Results
For the three months ended March 31, 2021, compared to the prior
year:
- Research and Development (R&D) expenses: R&D
expenses for the first quarter of 2021 were $5.3 million, compared
to $2.2 million for the same period in 2020.
- General & Administrative (G&A) expenses: G&A
expenses for the first quarter of 2021 were $2.6 million, compared
to $1.6 million for the same period of 2020.
- Net Loss: TFF Pharmaceuticals reported a net loss for
the first quarter of 2021 of $7.7 million, compared to a net loss
of $3.8 million for the same period of 2020.
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 CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended
March 31, 2021
Three Months Ended
March 31, 2020
Grant revenue
$
24,315
$
—
Operating expenses:
Research and development
5,278,252
2,235,542
General and administrative
2,647,415
1,617,924
Total operating expenses
7,925,667
3,853,466
Loss from operations
(7,901,352
)
(3,853,466
)
Other income:
Other income
231,278
—
Interest income
15,499
56,268
Total other income
246,777
56,268
Net loss
$
(7,654,575
)
$
(3,797,198
)
Net loss per share, basic and diluted
$
(0.33
)
$
(0.20
)
Weighted average common shares
outstanding, basic and diluted
23,140,607
19,008,611
TFF PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31, 2021
December 31,
2020
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
58,055,122
$
35,300,805
Prepaid assets and other current
assets
1,721,184
2,258,229
Total current assets
59,776,306
37,559,034
Property and equipment, net
1,577,441
1,102,808
Total assets
$
61,353,747
$
38,661,842
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
1,817,034
$
1,297,725
Deferred research grant revenue
—
24,315
Total liabilities
1,817,034
1,322,040
Commitments and contingencies
Stockholders’ equity:
Common stock
25,364
22,535
Additional paid-in capital
101,535,068
71,648,453
Accumulated other comprehensive loss
(89,496
)
(51,538
)
Accumulated deficit
(41,934,223
)
(34,279,648
)
Total stockholders’ equity
59,536,713
37,339,802
Total liabilities and stockholders’
equity
$
61,353,747
$
38,661,842
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210513005977/en/
Company Contacts:
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 Contact: Paul Sagan
LaVoieHealthScience psagan@lavoiehealthscience.com 617-865-0041
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