11/15/2021 | Press release | Distributed by Public on 11/15/2021 15:10
Positive Updates Announced for Inhaled Voriconazole and Tacrolimus Programs;
Both Programs Advancing into Phase 2 Testing
Continued Progress with Partnered Antiviral Programs for AUG-3387 and Niclosamide
Thin Film Freezing Applications Continue to Expand Across Diverse Set of Drug Candidates; IP Estate Now Includes Over 120 Patents Granted or Pending
Conference Call and Webcast Scheduled Today, Monday, November 15, 2021,
at 4:30 PM ET
AUSTIN, Texas, Nov. 15, 2021 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2021, and also provided an update on recent corporate and clinical developments. The Company will discuss the highlights on a conference call and webcast, scheduled today, Monday, November 15, 2021, at 4:30 PM ET.
"Over the last three months, we have made significant progress in every aspect of our business," said Glenn Mattes, CEO of TFF Pharmaceuticals. "Starting with our two lead in-house programs, Inhaled Voriconazole and Tacrolimus Powder, we achieved important clinical milestones that we believe will drive significant shareholder value. With respect to voriconazole, the safety results from both our Phase 1 and Phase 1b studies have allowed us to select a dose to study in our upcoming Phase 2 programs, which we plan to initiate around year-end."
"Results from our Phase 1 study for Inhaled Tacrolimus Powder indicate that our inhaled product has an acceptable safety profile to achieve the appropriate balance of local and systemic concentrations for immunosuppression at the site of the lung transplant while minimizing the risk of supra-therapeutic exposure well known to cause significant renal toxicity in patients. Based on the data, we expect to initiate the Phase 2 program shortly."
"We are also making outstanding progress in our two antiviral-focused partnerships, which provided yet another major source of external validation showing how our Thin Film Freezing technology can be applied to both small molecules and biologics. In October, TFF Pharmaceuticals and Augmenta announced the publication of positive in vivo data showing that the dry powder formulation of COVID-19 antibody AUG-3387 neutralizes SARS-CoV-2 infection and reduces viral load in a well-accepted preclinical model. The data from the AUG-3387 animal efficacy trial confirmed activity in the most virulent COVID-19 variants, including Delta, Lambda, and Mu. For niclosamide, a broad-spectrum antiviral, just two weeks after receiving approval from Health Canada, we enrolled and dosed the first patient in the Phase 1 trial."
"From our perspective, momentum only continues to build across the breadth of our diverse portfolio. The progress we have made and expect to make moves our entire internal portfolio closer to monetization and meaningful revenue streams for TFF."
"Looking ahead, we believe 2022 is shaping up to be another year of significant accomplishments. As our clinical programs with inhaled tacrolimus and voriconazole continue to advance, we expect to generate substantial proof-of-concept data within each program's targeted patient populations. Both the Inhaled Voriconazole and Inhaled Tacrolimus Powder Phase 2 programs will be designed with an interim analysis of data, and we expect these datasets will be available by mid-2022. We will begin a process in the first quarter of 2022 to identify license partners to ultimately commercialize these assets. We have already received interest from pharmaceutical companies and will use the interim data as the inflection point to pursue the partnerships."
"Importantly, the applicability of Thin Film Freezing in creating successful formulations in biologics and complex molecules continues to grow. For example, we have recently seen a strong uptick in the number of mAbs and mRNA-based therapeutics being evaluated by our large pharma partners, and we expect this trend will continue. The applicability of our Thin Film Freezing technology across a broad array of different molecules has also enabled us to greatly expand our IP estate. TFF now has approximately 120 patents either granted or pending both in the United States and the rest of the world."
"Without question, another important source of expanding applications of Thin Film Freezing comes from our academic and government collaborations, and I am pleased to report that each of these highly valued partnerships are proceeding very well. Our work with Dr. Ted Ross at the University of Georgia in testing a universal flu vaccine has proceeded to the animal testing phase, and our work with Dr. Drew Weissman at the University of Pennsylvania is now in full swing looking at the application of Thin Film Freezing technology in mRNA vaccines and therapeutics. Noting the potential of our technology platform, Dr. Weismann provided the following comment: 'The freeze-dried powder formulation by TFF has enormous potential to move the mRNA-LNP vaccine platform to efficient worldwide use by allowing room temperature storage and the development of oral inhaled delivery.'"
"We have also made substantial progress with the Defense Advanced Research Projects Agency (DARPA) Personalized Protective Biosystem (PPB) contract on formulating countermeasures and the development of novel vaccines at the United States Army Medical Institute of Infectious Diseases (USAMRIID) is also progressing. We expect a second Cooperative Research and Development Agreement (CRADA) shortly expanding the work we are doing in the vaccine arena."
"On the partnering front, the number of drug candidates being evaluated by our partners continues to grow and, just as importantly, we are seeing an expansion in the diversity of molecules being tested with our Thin Film Freezing technology. We expect to sign meaningful partnering transactions in the very near future. It is abundantly clear that the interest from our pharmaceutical, academic and government partners in our platform formulation technology continues to grow, and we are highly confident this interest will create multiple pathways toward increasing shareholder value."
Conference Call and Webcast Information
The Company will host a conference call today, Monday, November 15, 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: (866) 269-4261
International Dial-In Number: (323) 289-6581
Conference ID: 6229028
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://78449.themediaframe.com/dataconf/productusers/vvdb/mediaframe/46954/indexl.html
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:
Financial Results
For the three months ended September 30, 2021, compared to the prior year:
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 over 120 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) 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 Voriconazole and Tacrolimus, (ii) the risk that the Company may not be able to find a license partner to ultimately commercialize its dry powder versions of Voriconazole and Tacrolimus on terms favorable to the Company, or at all, (iii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iv) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (v) 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 September 30, 2021 |
Three Months Ended September 30, 2020 |
Nine Months Ended September 30, 2021 |
Nine Months Ended September 30, 2020 |
||||||||||||
Grant revenue | $ | 50,000 | $ | - | $ | 76,165 | $ | - | |||||||
Operating expenses: | |||||||||||||||
Research and development | 6,339,993 | 2,823,669 | 14,380,415 | 7,626,982 | |||||||||||
General and administrative | 2,387,585 | 2,254,912 | 7,386,007 | 5,147,639 | |||||||||||
Total operating expenses | 8,727,578 | 5,078,581 | 21,766,422 | 12,774,621 | |||||||||||
Loss from operations | (8,677,578 | ) | (5,078,581 | ) | (21,690,257 | ) | (12,774,621 | ) | |||||||
Other income: | |||||||||||||||
Other income (expense) | (13,129 | ) | - | 659,695 | - | ||||||||||
Interest income | 12,051 | 20,546 | 41,619 | 102,809 | |||||||||||
Total other income (expense) | (1,078 | ) | 20,546 | 701,314 | 102,809 | ||||||||||
Net loss | $ | (8,678,656 | ) | $ | (5,058,035 | ) | $ | (20,988,943 | ) | $ | (12,671,812 | ) | |||
Net loss per share, basic and diluted | $ | (0.34 | ) | $ | (0.24 | ) | $ | (0.85 | ) | $ | (0.61 | ) | |||
Weighted average common shares outstanding, basic and diluted | 25,371,781 | 20,867,526 | 24,635,350 | 20,810,004 | |||||||||||
TFF PHARMACEUTICALS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, | December 31, | ||||||
2021 | 2020 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 44,715,743 | $ | 35,300,805 | |||
Receivable due from collaboration agreement | 831,061 | - | |||||
Research and development tax incentive receivable | 1,111,540 | - | |||||
Prepaid assets and other current assets | 833,630 | 2,258,229 | |||||
Total current assets | 47,491,974 | 37,559,034 | |||||
Property and equipment, net | 1,810,235 | 1,102,808 | |||||
Total assets | $ | 49,302,209 | $ | 38,661,842 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,557,612 | $ | 1,297,725 | |||
Deferred research grant revenue | - | 24,315 | |||||
Total liabilities | 1,557,613 | 1,322,040 | |||||
Commitments and contingencies | |||||||
Stockholders' equity: | |||||||
Common stock | 25,372 | 22,535 | |||||
Additional paid-in capital | 103,158,144 | 71,648,453 | |||||
Accumulated other comprehensive loss | (170,328 | ) | (51,538 | ) | |||
Accumulated deficit | (55,268,591 | ) | (34,279,648 | ) | |||
Total stockholders' equity | 47,744,597 | 37,339,802 | |||||
Total liabilities and stockholders' equity | $ | 49,302,209 | $ | 38,661,842 |
Company Contacts:
Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc
[email protected]
737-802-1973
Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
[email protected]
817-989-6358
Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
[email protected]
Media Contact:
Gwendolyn Schanker
LifeSci Communications
269-921-3607
[email protected]
1 Denning DW, Pleuvry A, Cole DC. Global burden of allergic bronchopulmonary aspergillosis with asthma and its complication chronic pulmonary aspergillosis in adults. Med Mycol. 2013 May;51(4):361-70. doi: 10.3109/13693786.2012.738312. Epub 2012 Dec 4. PMID: 23210682. Accessed November 5, 2021.
Source: TFF Pharmaceuticals, Inc.