TFF Pharmaceuticals Closes on $14 Million to Advance Pipeline


Austin, Texas-based TFF Pharmaceuticals closed on a Series A financing worth $14 million. The National Securities Corporation, a wholly-owned subsidiary of National Holdings, was sole placement agent. Liquid Venture Partners group at National Securities Corporation sourced and executed the offering.

The funds will be used to advance the company’s pipeline of dry powder drugs for pulmonary diseases and conditions, including lung transplant, severe asthma, COPD, and pulmonary infections. The company’s technology is Thin Film Freezing (TFF), a proprietary platform that improves the solubility of drugs that have poor water solubility. It doesn’t require a proprietary device or delivery molecule to deliver the drugs deep in the lungs.

Drugs that don’t dissolve well in water can’t be delivered as dry powder, and must be delivered some other way, such as orally or intravenously. TFF formulations target the lungs directly and can be delivered via inhaler.

The technology is exclusively licensed from the University of Texas at Austin.

“We are excited with the strong investor interest in TFF and pleased to have this caliber of investors participate in our initial equity financing,” said Robert Mills, TFF’s chief executive officer, in a statement. “The investment represents a strong vote of confidence in TFF’s product pipeline of unique dry powder formulations for new pulmonary products; and our ability to generate dozens of potential drug candidates with promising commercial potential.”

The key difficulty for lung diseases is directly delivering the medication to the disease site. Oral formulations that go through the digestive system have the problem of systemic side effects, which are potentially life-threatening. Biopharma companies have tried a number of approaches, including microcapsules, carriers, and other agents, but often bring on unintended side effects.

TFF’s approach reformulates the drugs in a lung-friendly manner that allows direct delivery to the lungs. The company notes on its website that, “This means that drugs of all types—small molecules, biologics, even combinations—can be dosed direct to the lungs with few, if any, side effects.”

In the summer of 2017, researchers at London, UK-based Imperial College published a study in the scientific journal Pulmonary Circulation that describes a technology to transport drugs directly to the lungs in patients with pulmonary arterial hypertension (PAH). Like TFF, the researchers developed an approach that directly targets the lungs. In their case, the technology was made up of nanoparticles consisting of ethanol-heated iron and trans-trans muconic acid.

The company’s lead researcher, Jane Mitchell, told in-Pharma Technologist, “One of the biggest limitations in nanomedicine is toxicity, some of the best nanomedicine structures do not make it past the initial stages of development, as they kill cells.”

But the UK researchers used metal organic frameworks (MOF), which do not harm the cells in the lungs. “We made these prototype MOFs, and have shown they were not toxic to a whole range of human lung cells,” Mitchell said. “The hope is that using this approach will ultimately allow for high concentrations of drugs we already have, to be delivered to only the vessels in the lung, and reduce side effects.”

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