Fort Worth & Austin, Texas

CEO Glenn Mattes, VP of Product Development and Manufacturing Dr. John Koleng, and their team are disrupting traditional pharmaceutical development and manufacturing with exciting new technology.

Glenn Mattes

Mattes says there isn’t an official founding date for TFF Pharmaceuticals
(NASDAQ TFFP) as the company sprung from another Austin-based organization known as Lung Therapeutics circa 2017.

“The [thin film freezing] technology itself was invented by Dr. Bill Williams,” Mattes explains. “He is a professor of pharmaceutics at the University of Texas at Austin. Bill developed the technology along with another pharmaceutical partner for many years, exclusively licensed from the university. After that partnership was terminated, the technology reverted back to the University of Texas at Austin and was licensed to Lung Therapeutics. Then TFF was spun out as its own entity.”

Mattes joined the company as CEO five years ago. “We went public a little over three years ago,” he adds, noting that the core TFF team — including Koleng — has been with the clinical-stage biopharmaceutical company since its inception.

“Clinical stage means we’re developing compounds that are being used in trials in patients,” Mattes says. “As opposed to preclinical, where you’re working with lab animals and doing preclinical experiments. In the clinical stage, you’ve been approved by the FDA to be used in humans. And then you go through the clinical development process, testing your products or compounds in human subjects, mostly within this specific therapeutic area for that specific indication.”

TFF Pharmaceuticals currently has a portfolio of three clinical stage compounds in trials and one preclinical stage compound in the works. The company’s patented thin film freezing technology is designed to transform medicines into dry powder, overcoming key limitations with traditional drug delivery in the process.

Dr. John Koleng

“The research and development process for thin film freezing involves first a detailed assessment of what we would consider to be the active substance that drives the therapeutic,” says Koleng. “Voriconazole [TFF VORI] and tacrolimus [TFF TAC] are examples. A lot of work that we do is focused not only on those types of compounds, which we call small molecules, but we have an even larger extensive research and development effort on what we call biologics or large molecules. Those include proteins, peptides, viruses, vaccines, etcetera — something like the mRNA vaccine, for instance.”

After completing a detailed analysis of the active substance’s properties, it is married with other ingredients to provide enhanced benefits to the final dry powder composition.

“This could be things that are added to facilitate administration,” Koleng continues. “Aerosolization, for instance, for inhalation, stability, etcetera. And then we combine that with our thin film freezing dry powder particle engineering technology, which is a process where we convert that ultimately into a dry powder with enhanced physical and chemical properties that deliver a very specific advantage — or more than one advantage — in the final form that is not achievable through traditional pharmaceutical manufacturing processes. It’s a very methodical research and development effort that brings together material science, process science, and then ultimately an eye towards elegant pharmaceutical compositions that have excellent patient uptake and acceptability.”

Mattes says TFF Pharmaceuticals operates with a hybrid corporate strategy. “We have a portfolio of opportunities that we develop ourselves,” he explains. “The goal is to take them to meaningful clinical inflection points and then find a partner to license these compounds out for the final work that needs to be done to get the products approved and then to commercialize.”

Mattes continues, “Then our business development platform is we license the thin film freezing technology to pharmaceutical companies, academia, and the government to apply the technology against their assets. So, they give us their materials, we formulate dry powder formulations using the TFF technology, then we go back to the partner to determine what other experiments we would want to do before we can monetize those relationships.”

TFF Pharmaceuticals recently leased a new facility in Austin with over 3,500 square feet of lab space.

“This is an extension of the work that TFF has been doing for more than a year in [a smaller space],” Koleng says. “We were originally in a small laboratory in an incubator space. But due to the continued upward trajectory of interest — not only from third-party collaborations — but we’re seeing continued growth and support for our internal program as well. The new 3,500-square-foot facility provides us with significant runway to continue to not only support the expanding needs of our internal programs — those of our existing clientele — but also to continue to support the onboarding of an ever-increasing number of new collaborators as well.”

Once TFF has developed a pharmaceutical utilizing their patented technology, they enlist the help of contract manufacturing organizations for production. “We place large-scale equipment that we have designed at these CMOs,” Koleng says. “We then direct the installation, implementation, and execution of our work on that equipment in close collaboration with those CMO partners.”

Finding the right contract manufacturers to work with has been challenging to some extent, Koleng says. “It’s really been driven more by, I would say, our specifications in finding partners that we believe represent best-in-class for understanding and adapting new technology,” he continues. “It’s a unique brand of CMO that is looking to onboard something new like the TFF technology. So, we’ve been very selective not only in choosing who we work with, but then also limiting that search to those who are truly innovators in their own right, if you will.”

Challenges: Mattes says that “execution of the plan, successful data from our clinical trials, finishing up the work that we’re doing with our partners to enable licenses, and keeping up with growth” are TFF Pharmaceuticals’ biggest challenges. “Managing growth efficiently,” he adds, “in a responsible way fiscally. And, ultimately, returning optimal value back to our shareholders is what we’re accountable for.”

Opportunities: Mattes says new partnerships are the company’s biggest opportunities. “They’re all out there for us to execute against.”

Needs: “A need to continue to identify top talent for the company in fairly aggressive hiring,” Koleng says. “Even with the inflation — depending on which jobs report you read — it’s still difficult to find the best talent. They are so highly sought after, especially in a technology field.”


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