Prokaryotics Receives National Institutes of Health Award Supporting Preclinical Development of its Tarocin:ß-Lactam Potentiation Program to Treat Life-Threatening Methicillin-Resistant Staphylococcus aureus (MRSA) Infections

Union, NJ – December 22, 2025 -- Prokaryotics Inc., a privately-held biopharmaceutical company engaged in the discovery and development of novel anti-infective drugs, announced today that it has been awarded its third National Institute of Allergy and Infectious Diseases (NIAID) grant to support the development of its tarocin potentiator program. This program constitutes one of five innovative core projects within a 5-year U19AI189168 grant of $37.8 M awarded to Dr. David Perlin (Chief Scientific Officer, Hackensack Meridian Health Center of Discovery Innovation [HMH CDI]) to support a Center of Translational Excellence (CETR) and innovative new strategies to address antibacterial resistance. To date, the Prokaryotics team has led the conception, discovery, and development of the tarocin program, culminating in the selection of its first preclinical candidate (PCC). Through collaboration with Dr. Perlin and HMH CDI, the U19 award will facilitate the initiation of investigative new drug (IND)-enabling preclinical studies. These studies are anticipated to ultimately support an IND application for the tarocin PCC to the Food and Drug Administration (FDA) prior to clinical Phase 1 safety, tolerability and pharmacokinetic studies in humans.

Tarocins are a new class of antibiotic potentiators that restore the bactericidal activity of ß-lactams against otherwise methicillin resistant Staphylococcus aureus (MRSA) by a mechanistically novel means. Unlike the clinically successful ß-lactamase inhibitors, which directly inhibit ß-lactamase enzymes that inactivate ß-lactam antibiotics among Gram-negative bacterial pathogens (including Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa), tarocins inactivate the synthesis of a Gram-positive cell wall polymer that is able to protect MRSA from the effects of ß-lactam antibiotics. This orthogonal strategy to restore ß-lactam activity offers the exciting opportunity to once again treat MRSA infections with a broad suite of existing ß-lactam antibiotics in combination with the tarocin potentiator. Further, as an orally administered MRSA treatment, the product would serve as the only orally administered alternative to the oxazolidinones.

We are extremely grateful to NIAID for their continued support of this program, and of Prokaryotics more broadly. Antibiotic resistance is a global crisis, and MRSA represents one of the most pernicious bacterial pathogens comprising this threat. The tarocin potentiator program offers a mechanistically novel approach to treating life-threatening MRSA infections. The opportunity to broadly reintroduce ß-lactam antibiotics in this clinical setting would be a game changer, reversing 60 years of the MRSA resistance era and returning to both clinicians and patients a reliable and safe antibiotic drug class to once again treat these deadly infections.
-- Terry Roemer PhD., Chairman and Chief Scientific Officer at Prokaryotics Inc.

The global threat of antibiotic resistance demands innovative strategies to preserve and extend the usefulness of existing drugs, while advancing new therapeutic classes. Prokaryotics’ tarocin drug potentiator program brings a truly fresh and promising approach to addressing this critical challenge.
-- Dr. David Perlin, Chief Scientific Officer at Hackensack Meridian Health Center of Discovery Innovation [HMH CDI]

About Antimicrobial Resistant (AMR) Bacterial Infections
The relentless advance of antibiotic drug-resistant bacteria has raised concerns whether within the next 2-3 decades we could be facing a ‘pre-antibiotic era’ where existing antibiotics will become largely ineffective in treating serious and life-threatening infections. Indeed, the World Health Organization has projected that the impact on human health and economic costs associated with antibiotic drug resistance will rival that of global warming. Whereas continued improvements to existing antibiotics certainly stretch such timelines, entirely new classes of antibiotics with novel mechanisms of action are urgently needed to combat AMR bacteria.

About Prokaryotics, Inc.
Prokaryotics, Inc. is a biopharmaceutical company founded on Merck & Co. out-licensed antibiotic assets under development to treat life-threatening AMR infections. Prokaryotics leverages its deep expertise in microbial physiology, medicinal chemistry, collaborative spirit, and scientific passion to discover and develop new classes of antibiotics specifically targeting bacterial and fungal cell wall and cell envelope biogenesis – the fundamental armor erected by these pathogens to naturally withstand the effects of antibiotic treatment and the human innate immune system.

www.prokaryotics.com