TFF Pharmaceuticals Inc. (TFFP:NASDAQ) new sole focus on its internal programs should result in a near-term value creation point with each of its two lead drug candidates, reported ROTH Capital Partners analyst Dr. Jonathan Aschoff in an April 3 research note.
The biopharma uses its patented rapid Thin Film Freezing (TFF) technology to develop and transform medicines into potent dry powder formulations for improved efficacy, safety, and stability. Its two investigative products are TFF-Vori, voriconazole inhalation powder, and TFF-Tac, tacrolimus inhalation powder. Currently, TFF Pharmaceuticals is activating sites for a Phase 2 clinical trial of each of them.
"TFF-Vori and TFF-Tac have the potential to redefine the current standard of care in fungal lung infection and lung transplantation, respectively," Aschoff commented.
1,929% Implied Return
The Texas-headquartered company offers investors robust potential gains of about 1,929% given the difference between TFF Pharmaceuticals' US$0.69 current share price and ROTH's US$14 per share target price on the biopharma. It is a Buy.
The next catalyst for TFF Pharmaceuticals, noted Aschoff, will be topline results from the TFF-Vori Phase 2 study, expected this year. Site initiation recently has ramped up for the trial, and more sites are to open in Spain in the coming weeks.
The subsequent catalyst will be topline data from the TFF-Tac Phase 2 trial. The biopharma is striving to achieve this in 2023, but ROTH believes it will not happen until 2024. This is because fewer sites have been activated so far for the TFF-Tac trial than for the TFF-Vori trial.
Balance Sheet Status
With US$16.6 million in cash at the end of Q4/22, Aschoff pointed out, TFF Pharmaceuticals has enough to fund operations into early H2/23 and likely until the realization of the first catalyst, the TFF-Vori Phase 2 data readout.
The event will be "a value creation point that should facilitate subsequent funding," Aschoff added.
Focus on Internal Programs
As TFF Pharmaceuticals moves forward, wrote Aschoff, it intends to concentrate on generating its own clinical results. To support this initiative, the biopharma hired its first chief medical officer, Dr. Zamaneh Mikhak. Most recently he was the senior vice president and head of clinical development for Cogent Biosciences. Dr. Harlan Weisman, TFF's new chief executive officer, will oversee the company's new internal focus.
"We believe that the new refined focus on internal programs is a wise decision," wrote Aschoff.
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Disclosures For Roth Capital Partners, TFF Pharmaceuticals Inc., April 3, 2023
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
Disclosures: Within the last twelve months, ROTH Capital Partners, or an affiliate to ROTH Capital Partners, has received compensation for investment banking services from TFF Pharmaceuticals, Inc.. ROTH makes a market in shares of TFF Pharmaceuticals, Inc. and as such, buys and sells from customers on a principal basis. Shares of TFF Pharmaceuticals, Inc. may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate. This report should not be used as a complete analysis of the company, industry or security discussed in the report. Additional information is available upon request. This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high degree of risk and may not be suitable for all investors. No part of this report may be reproduced in any form without the express written permission of ROTH.