PLx Pharma has filed an S-1 form with the U.S. Securities and Exchange Commission (SEC) regarding its initial public offering (IPO). No pricing details were given in the filing, but the offering is valued up to $80.5 million. The company intends to list on the Nasdaq Capital Market under the symbol PLXP.
The underwriters for the offering are Raymond James, Maxim Group and Janney Montgomery Scott.
This late-stage specialty pharmaceutical company initially is focused on developing its clinically validated and patent-protected PLxGuard delivery system to provide safer and more effective aspirin products. The PLxGuard delivery system works by releasing active pharmaceutical ingredients into the duodenum, the first part of the small intestine immediately below the stomach, rather than in the stomach itself. The company believes this improves the absorption of many drugs currently on the market or in development, as well as reduces acute gastrointestinal (GI) side effects — including erosions, ulcers and bleeding — associated with aspirin and ibuprofen, and potentially other drugs.
The U.S. Food and Drug Administration (FDA) has approved PLx’s lead product, PL2200 Aspirin 325 mg, as a novel formulation of aspirin that uses the PLxGuard delivery system to significantly reduce acute GI side effects while providing superior antiplatelet effectiveness for cardiovascular disease prevention as compared with the current standard of care, enteric coated aspirin.
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In the filing, PLx said:
Our commercialization strategy will target both the over-the-counter (OTC) and prescription markets, taking advantage of the existing OTC distribution channels for aspirin while leveraging the FDA approval of PL2200 Aspirin 325 mg and expected approval for PL2200 Aspirin 81 mg for OTC and prescription use when recommended by physicians for cardiovascular disease treatment and prevention. Given our clinical demonstration of better antiplatelet efficacy (as compared with enteric coated aspirin) and better acute GI safety, we intend to use a physician-directed sales force to inform physicians—and, by extension, consumers—about our product’s clinical results in an effort to command both greater market share and a higher price for our superior aspirin product. Our product pipeline also includes other oral nonsteroidal anti-inflammatory drugs (NSAIDs) using the PLxGuard delivery system that may be developed, including a clinical-stage, GI-safer ibuprofen—PL1200 Ibuprofen 200 mg—for pain and inflammation.
The company intends to use the net proceeds from the offering to advance its products to market readiness, develop its brand and hire a physician-directed sales force. The remainder will be used for working capital and general corporate purposes.
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