Hoth Therapeutics has filed to raise around $11 million in a Nasdaq IPO. The tiny offering will equip Hoth to test a topical formulation of the broad-spectrum antibiotic gentamicin in a phase 2 eczema trial.
New York-based Hoth, which began operating last year, is developing drugs that pair antibiotics to zinc chelators. The idea is to create topical drugs that stop colonies of bacteria forming as biofilms and thereby improve outcomes in patients with eczema and other skin conditions.
Hoth has limited evidence to support the hypothesis—the centerpiece of its pitch is a study run in two pigs—but the fact gentamicin is a well-established drug gives it a chance to advance quickly on the strength of the data. By following the 505(b)(2) pathway, Hoth thinks it can bring the drug to market in 2022 on the basis of a phase 2 trial and two registrational studies.
The IPO is intended to give Hoth the means to get that R&D effort underway. Hoth has earmarked some of the money for a phase 2 trial that is scheduled to start early next year. The plan is to enroll 50 to 100 pediatric eczema patients and randomize them to receive the gentamicin drug or a control.
If all goes according to plan, Hoth will complete the phase 2 around the middle of next year, setting it up to run two registrational trials, starting with a dose-ranging study. Hoth expects to complete the pivotal trials near the end of 2020 and file for FDA approval in the second half of the following year.
Although the sums and timelines involved in getting the drug to market are relatively small, the drug development program still carries risks for investors. Hoth has limited data on its drug and, by its own admission, its management team lacks pharma experience. CEO Robb Knie worked for years as a semiconductor analyst, while Hoth’s nominee for vice president of operations has a background as an office manager.
The nominated VP, Jane Behrmann, has some life sciences experience as an office manager at CBM BioPharma. Behrmann joined CBM at the start of the year having previously worked at Spherix. This week, Spherix struck a deal to merge with CBM.
In recent years, Spherix has been best known for buying patents and filing suits against companies it thinks have infringed them. The company also played a central role in the early months of Hoth and its path to Nasdaq. In June 2017, Hoth sold stock to Spherix for $675,000. As part of the deal, Hoth committed to file for an IPO “that covers the resale of 2,518,518 shares of common stock issued to Spherix” in the June 2017 deal.