TFF Pharmaceuticals Inc. (TFFP) Misses Q4 EPS by 3c

TFF Pharmaceuticals Inc. (NASDAQ: TFFP) reported Q4 EPS of ($0.26), $0.03 worse than the analyst estimate of ($0.23).

“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.”

For earnings history and earnings-related data on TFF Pharmaceuticals Inc. (TFFP) click here.

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