TFFP TFF Pharmaceuticals Inc - Ordinary Shares
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Voriconazole Inhalation Powder
Asthma
|
Phase 1b
Phase 1b
|
Phase 1b trial initiation announced December 15, 2020.
|
|
Voriconazole Inhalation Powder
Invasive Pulmonary Aspergillosis (IPA)
|
Phase 1
Phase 1
|
Phase 2 trial planned.
|
|
Tacrolimus Inhalation Powder
Prophylaxis of lung allograft rejection
|
Phase 1
Phase 1
|
Phase 1 completion of SAD dosing announced October 20, 2020.
|
Latest News
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Company conference call and webcast at 4:30 PM 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 announced that it will release its financial results and business update for the first quarter of 2021 on Thursday, May 13, 2021 at the close of the U.S. financial markets.
Management will host a conference call to discuss the financial results and provide an update on recent corporate and clinical developments at 4:30 PM EDT. A question-and-answer session with investors will follow management's remarks.
Conference Call Details:
Thursday, May 13, 2021, 4:30 PM Eastern Time (EDT)
Domestic Dial-In Number: Toll-Free: (800) 816-3024
International Dial-In Number (857) 770-0106
Conference ID: 5777388
Webcast Registration Link: https://edge.media-server.com/mmc/p/o4wvnbiv
Please access the Webcast Registration Link 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, https://tffpharma.com, in the Events Calendar of the Investors section.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210504005800/en/
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Company's Thin Film Freezing platform to be developed for use in rapidly neutralizing chemical and biological threats at vulnerable tissue barriers to increase soldier protection and decrease operational burden
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 announced that Leidos, a leading Fortune 500 information technology, engineering and science solutions and services leader, has 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.
The PPB research program, overseen by the Defense Advanced Research Projects Agency (DARPA), will develop an integrated system that simultaneously reduces protective equipment needs while increasing protection for the individual against existing and future chemical and biological (CB) threats. This will be achieved through lightweight materials that protect the warfighter or stability operator from exposure to CB threats, while simultaneously providing a second layer of protection, at the tissue barrier, with bio-molecular, commensal organisms, or other technologies that protect the skin, eyes, and airway from CB threats. Successful PPB technologies could change how the military and public health communities perform in unpredictable threat environments.
Under the 60-month, three-phase subcontract with Leidos, 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, the eyes and the respiratory system. Phase I of the program will include the development and validation of methods to quantify countermeasures and the formulation of countermeasures for delivery to the various tissue. Phase II will include the scale up manufacturing of countermeasure formulations for preclinical studies, demonstration of the deliverability of countermeasure products and meeting with the FDA to determine a path to GMP production of the countermeasure formulations, nonclinical safety testing, and a pathway to human clinical testing. Phase III will include plans for scale-up manufacturing for human safety trials.
"We are very pleased that Leidos selected our Thin Film Freezing platform to help develop the next generation of chemical and biological protective technologies for our frontline warfighters and stability operators," said Glenn Mattes, President and CEO of TFF Pharmaceuticals. "The Personalized Protective Biosystems program will develop groundbreaking technology and we are proud to be able to play a role in this program that will have strategic impact to this country for years to come."
About Leidos
Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 37,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Va., Leidos reported annual revenues of approximately $11.09 billion for the fiscal year ended January 3, 2020. For more information, visit www.leidos.com.
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 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 Company's participation in the Personalized Protective Biosystems (PPB) Program and the benefits of the Company's TFF platform. 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 PPB not successfully develop the proposed countermeasures utilizing the Company's TFF platform, (ii) the risk that Leidos and the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of the proposed countermeasures utilizing the Company's TFF platform, (iii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, and (iv) 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.
"This Press Release was cleared by DARPA under Distribution Statement "A" (Approved for Public Release, Distribution Unlimited)."
View source version on businesswire.com: https://www.businesswire.com/news/home/20210413005710/en/
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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 announced that it has priced an underwritten offering of 2,855,000 shares of its common stock, 2,140,000 shares of which are to be sold by the Company and 715,000 shares of which are to be sold by Lung Therapeutics, Inc. ("Selling Stockholder"), at an offering price of $14.00 per share. TFFP expects the aggregate gross proceeds from this offering to be approximately $40 million, before deducting the underwriting discount and commissions and other estimated offering expenses, of which approximately $10 million of the gross proceeds will be received by the Selling Stockholder. TFFP expects to close the offering, subject to customary conditions, on or about March 30, 2021.
TFFP intends to use the net proceeds from the proposed offering for working capital and general corporate purposes.
Roth Capital Partners acted as sole book-running manager for the offering.
The offering of common stock was made pursuant to TFF Pharmaceuticals' shelf registration statement filed with the Securities and Exchange Commission ("SEC") and declared effective. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.
A preliminary prospectus supplement has been filed with the SEC and a final prospectus supplement will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered may be obtained, when available, from Roth Capital Partners, LLC. 888 San Clemente Drive, Newport Beach, CA 92660, Attention: Prospectus Department, by telephone at (800) 678-9147 or by email at [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the SEC's website at http://www.sec.gov.
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.Safe Harbor
This press release contains forward-looking statements regarding the expected closing of the underwritten offering and the intended use of proceeds from the offering. The offering is subject to customary closing conditions and there can be no assurance as to whether or when the offering may be completed. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including those risks disclosed under the caption "Risk Factors" in the preliminary prospectus supplement related to the offering. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. The Company does not undertake, and specifically disclaims any obligation, to update or revise such statements to reflect new circumstances or unanticipated events as they occur.View source version on businesswire.com: https://www.businesswire.com/news/home/20210326005237/en/
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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: 9195779The 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:
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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.
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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.
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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.
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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, 2020Three Months
Ended
December 31,
2019Year Ended
December 31, 2020Year Ended
December 31, 2019Operating 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 diluted22,759,329
14,338,249
20,425,162
6,904,983
TFF PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
As of
December 31,
2020As of
December 31,
2019Assets
(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, respectively22,535
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/
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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.
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RADNOR, Pa. and AUSTIN, Texas, March 9, 2021 /PRNewswire/ -- NeuroRx, Inc. and TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) are announcing that the companies have entered into a feasibility and material transfer agreement (Feasibility Agreement). Under the Feasibility Agreement, NeuroRx is delivering ZYESAMI™ (aviptadil, synthetic VIP) materials to TFF in order to perform feasibility formulation work and testing. The goal of this feasibility work is to formulate and identify an optimal, long term-stable formulation of ZYESAMI™ in a dry powder form which has superior aerosol properties for delivery directly to the lungs.
ZYESAMI is a synthetic form of a naturally occurring peptide found in the lung called Vasoactive Intestinal Peptide (VIP), which is known to protect the Alveolar Type II cell that is targeted by the SARS-CoV-2 virus. The symptoms of COVID-19 are attributable to decreased surfactant production and increased cytokine production caused by Coronavirus infection of the Type II cell. This may also be a common pathway in sepsis-induced Acute Respiratory Distress Syndrome (ARDS) and Checkpoint Inhibitor induced pneumonitis associated with certain cancer drugs.
Loss of surfactant production in the lung may be the direct cause of the profound hypoxia or respiratory failure seen in COVID-19. The ability to deliver VIP 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.
"We are excited that ZYESAMI has demonstrated a highly significant reduction in time to hospital discharge for seriously ill Covid-19 patients treated with High Flow Nasal Oxygen, along with an increased likelihood of recovery and excellent safety," said Jonathan C. Javitt, M.D., M.P.H., CEO of NeuroRx. "Although our current production methods yield a drug that is sufficiently stable for emergency use, a long-term, shelf stable formulation will be needed for ongoing use of ZYESAMI, once the pandemic subsides. The thin film freezing technology holds great promise in potentially making this available to patients with other stages of Covid-19 with an inhaled form of ZYESAMI."
"The work being done by the NeuroRx team with ZYESAMI on behalf of critically ill patients with Covid-19 Respiratory Failure is both remarkable and gratifying," said Glenn Mattes, President & CEO of TFF Pharmaceuticals, "The potential opportunity to bring this important new therapeutic to patients earlier in the treatment cycle is exciting. We are very pleased to be collaborating with the NeuroRx Team with our thin-film freezing technology."
About VIP in COVID-19
Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970, for whom ZYESAMI™ is named. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 500 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type II cell (ATII), that is critical in the production of lung surfactant that is essential to transmission of oxygen from the air to the blood by the pulmonary epithelial cells that line the air sacs (alveoli) of the lung. Initial radiographic changes in Covid-19 are suggestive of collapse of these alveoli.Covid-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. The ATII cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. These specialized cells manufacture surfactant that coats the lung and is essential for oxygen exchange. Loss of surfactant causes collapse of the air sacs (alveolae) in the lung and results in respiratory failure.
VIP is shown to block Coronavirus replication in the ATII cell, block cytokine synthesis, block viral-induced cell death (cytopathy), and upregulate surfactant production. To our knowledge, other than ZYESAMI™, no currently proposed treatments for Covid-19 specifically target these vulnerable Type II cells. Recent laboratory findings suggest that VIP directly interferes with the spike protein complex of the SARS-CoV-2 virus.
About NeuroRx, Inc.
NeuroRx draws upon more than 100 years of collective drug development experience from senior executives of AstraZeneca, Eli Lilly, Novartis, Pfizer, and PPD. In addition to its work on ZYESAMI™, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression and is currently in Phase 3 trials. Its executive team is led by Prof. Jonathan C. Javitt, M.D., M.P.H., who has served as a health advisor to four Presidential administrations and worked on paradigm-changing drug development projects for Merck, Allergan, Pharmacia, Pfizer, Novartis and MannKind, together with Robert Besthof, MIM, who served as the Global Vice President (Commercial) for Pfizer's Neuroscience and Pain Division. NeuroRx recently announced a plan to complete a business combination with Big Rock Partners Acquisition Corp (NASDAQ:BRPA) ("BRPA") and intends to apply for listing on the NASDAQ under the proposed symbol "NRXP". For more information, visit www.neurorxpharma.com.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 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 a potential its dry powder version of NeuroRx's ZYESAMI. 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 NeuroRx and the Company may not be able to produce a dry powder version NeuroRx's ZYESAMI, (ii) the risk that NeuroRx and the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of a dry powder version of NeuroRx's ZYESAM, (iii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, and (iv) those other risks disclosed in the section "Risk Factors" included in the Company's prospectus supplement filed with the SEC on December 8, 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.
Corporate Contacts
NeuroRx, Inc.
Jonathan C. Javitt, M.D., MPH
Chairman and Chief Executive Officer
[email protected]Media Contact:
NeuroRx (US):
David Schull
Russo Partners, LLC
[email protected]
858.717.2310Investor Relations:
NeuroRx (US):
Brian Korb
Solebury Trout
[email protected]
917.653.5122TFF Contacts:
Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc.
[email protected]
737-802-1973Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
[email protected]
817-989-6358Investor Relations and Media Contact:
Paul Sagan
LaVoieHealthScience
[email protected]
617-953-4779
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