Israeli-based PolyPid Ltd. has offered a prospectus to raise $18 million-$22 million for an initial public offering (IPO).
Israel’s Ortho/Pharma Company PolyPid Offers IPO
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The company called off a planned NASDAQ IPO in late 2014 and the $18 million-$22 million is about the same amount the company hoped to raise last year.
The company has developed a delayed-release drug for treatment of compound fractures. According to the company website, PolyPid is an “emerging clinical stage specialty pharmaceutical company engaged in research and development of products based on PLEX (Polymer-Lipid Encapsulation MatriX), our proprietary drug delivery technology. PLEX is able to securely encapsulate many types of drugs, including proteins, to enable targeted, localized drug delivery into the body over periods of time ranging from days to several months.”
The problem with existing methods of delivering drugs to bones, according to the company, is the lack of blood flow to the bone, which means that an orally taken drug does not reach the bone in sufficient quantities and last only a short time. They must then be surgically replaced.
PolyPid’s technology reportedly facilitates sustained delayed release, and inserting the drug when the fracture is first treated is therefore sufficient. The product has applications in dentistry and in prevention of infections in compound bone fractures.
The PLEX matrix, according to the company, “protects the drug in vivo over extended periods of time without changing the chemistry of the drug. The application of our PLEX technology enables us to optimize drug treatment regimens by providing a unique combination of pre-determined release rates and durations. This combination allows us to create solutions to indications where existing systemic treatments as well as current local treatments are not sufficiently effective or safe, and at the same time to significantly lower the healthcare system economic burden.”
Last year, the company reported that a clinical study with PolyPid’s leading medical device, BonyPid, an antibiotic-loaded bone substitute, in severe, contaminated open fractures showed “early bone recovery, early soft tissue recovery, no amputations, and high safety profile—no infection in the target fracture.”
The product is scheduled to enter clinical trials in 2015 and the company hopes to enter the European market by 2017.
To date, PolyPid has reportedly raised $12.7 million. It lost $3.8 million in 2013 and $2.6 million in the first half of 2014.
The primary shareholders in the company are the Xenia incubator, which has a 16% pre-offering stake; the Friendly Angels club, headed by Adv. Jack Eitan Kyiet, who is also PolyPid’s COO (12.4%); inventor and CTO Noam Emanuel (7.1%); CEO and investor Amir Weisberg (5.3%); serial investor Arik Lukach (5.3%); and additional private investors.
In July 2014, the company announced that the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance for U.S. application Serial Number 13/574, 040, a patent covering compositions for sustained and/or controlled release of nucleic acid agents. A Notice of Allowance is the formal USPTO notification that an applicant is entitled to a patent under the law.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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