PolyPid takes another IPO shot, seeking $86M as it preps for phase 3

bacteria
Polypid is preparing for late-stage testing of lead product D-Plex in surgical site infections. (Image: Fotolia)

Three years after its last misfire, Israeli biotech PolyPid is having another go at listing on the Nasdaq, seeking $86 million to develop its pipeline of locally-acting anti-infectives.

The clinical-stage company officially filed the IPO documentation with the SEC yesterday, with Goldman Sachs, Cowen & Company and Cantor Fitzgerald as the joint bookrunners on the deal, says Renaissance Capital, which says pricing terms have not yet been disclosed.

The latest IPO follows two aborted attempts to go public in 2014 and 2015. PolyPid first sought to raise $22 million in a Nasdaq offering, later scaling back its ambitions to $20 million before scrapping the idea altogether and instead raising cash from private investors.

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PolyPid’s new IPO attempt comes as it prepares for late-stage testing of lead product D-Plex, a slow-release antibiotic reservoir given in a single injection that is designed to provide local prevention of bacterial infections at surgical sites.

D-PLEX takes the form of a polymer-encapsulated formulation of doxycycline and is being developed in three variants for different indications. The most advanced is D-Plex 100 for surgical site infections (SSIs) in bone and soft tissues, which is in a phase 1b/2 trial for the prevention of post-cardiac surgery sternal infection. PolyPid says it plans to file for approval to start a phase 3 program in the U.S. and Europe later this year.

Following behind are two other candidates, a bone void filler (D-Plex 1000) intended for use in orthopedic surgeries for the prevention of SSIs and support of bone recovery and another filler (D-Plex 500) designed to fill and reconstruct bone defects caused by infections around dental implants. The latter candidates are both in early-stage clinical testing, with PolyPid collaborating on the development of D-Plex 500 with Dentsply Sirona subsidiary MIS Implants Technologies.

News of the second IPO attempt comes shortly after PolyPid named pharma industry veteran Jacob Harel as chairman. Harel worked at Merck & Co for nearly 30 years—most recently as head of corporate business development—before leaving to set up his own consultancy in 2014.

At the time of Harel’s appointment, PolyPid CEO Amir Weisberg said the near-term objectives for the company included the start of the phase 3 program for D-Plex and the establishment of a sales and marketing presence in the U.S.