TFF Pharmaceuticals Inc. (TFFP) Misses Q1 EPS by 9c

TFF Pharmaceuticals Inc. (NASDAQ: TFFP) reported Q1 EPS of ($0.33), $0.09 worse than the analyst estimate of ($0.24).

“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.”

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

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