Salarius Pharmaceuticals has signed a definitive agreement with Decoy Therapeutics under which Decoy Therapeutics will merge with a wholly-owned subsidiary of Salarius Pharmaceuticals, subject to the closing conditions set forth in the definitive agreement. The newly formed company will be named Decoy Therapeutics.

This proposed transaction is expected to facilitate multiple value-creating inflection points with Decoy’s pipeline of peptide conjugate therapeutics engineered by its IMP3ACT platform, which allows for the rapid computational design and manufacturing of innovative peptide conjugate therapeutics including rapid response to novel viral pathogens such as avian H5N1 flu. Decoy’s product pipeline targets unmet needs in respiratory infectious diseases and gastroenterology (GI) oncology indications.

In addition, the combined company intends to incorporate Salarius’ oral small molecule protein degrader SP-3164 into a highly targeted peptide-based proteolysis targeting chimeras (PROTACS) drug candidate. The ongoing development of Salarius’ seclidemstat for hematologic cancers in an investigator-initiated Phase 1/2 clinical trial at MD Anderson Cancer Center (MDACC) will be supported while the company evaluates strategic alternatives for seclidemstat.

The combined company will be led by Decoy’s Co-founders, Chief Executive Officer Frederick ‘Rick’ Pierce and Chief Scientific Officer Barbara Hibner, by Decoy’s Chief Business Officer Peter Marschel, Chief Technology Officer Mike Lipp and acting Chief Medical Officer and Scientific Advisory Board Chair Shahin Gharakhanian, MD, and by Salarius’ Chief Financial Officer Mark Rosenblum.

The two companies have further agreed that upon closing of the merger and a post-closing shareholder vote approving the conversion of the preferred stock issued at closing, the newly merged company’s Board of Directors will be comprised of Rick Pierce and Barbara Hibner, and three independent Directors, two appointed by Decoy’s Board and one by Salarius’ Board.

Rick Pierce is a life sciences executive with more than 25 years of senior management experience across private and public companies. Previously he served as Vice President of Corporate Development and Investor Relations at Javelin Pharmaceuticals, a publicly traded company that developed Dyloject™ through EMEA approval, launch and NDA submission, at which time it was acquired by Hospira, Inc., now a subsidiary of Pfizer.

Earlier in his career, Pierce spent 15 years in investment banking at bulge bracket Wall Street firms primarily focused on corporate finance, institutional sales and trading in healthcare, biotechnology and technology, ultra-high-net worth individuals and family offices.

Pierce commented, “Peptide conjugates have become one of the most important drug classes as measured by prescription rates and revenue growth. Our highly experienced team is excited to be able to unlock significant shareholder value from our IMP3ACT platform, which can rapidly design new peptide conjugate drugs by applying ML and AI tools. Having access to capital and the visibility afforded by a public listing are significant corporate milestones that further enable Decoy to advance our expanded preclinical and clinical candidates to address important unmet patient needs.”

"After undertaking a comprehensive strategic review process, we believe that the proposed transaction with Decoy Therapeutics offers the best opportunity to create significant near- and long-term value,” stated David Arthur, President, CEO and Director of Salarius Pharmaceuticals.

“The compelling science supporting Decoy’s peptide conjugate technology and the company’s management team are truly impressive. Based on our diligence, we believe Decoy is poised to advance multiple drug candidates that address significant unmet needs in numerous therapeutic areas. The Board of Salarius and I would like to thank our stockholders for their support during this review process, and to reiterate the team’s commitment to enhancing shareholder value with this transaction and beyond,” added Arthur.

During the next 12 months, Decoy expects to advance its lead asset, a pan-coronavirus antiviral, to the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), and to make progress with its other programs including a broad-acting antiviral against flu, COVID-19 and respiratory syncytial virus (RSV), and a peptide drug conjugate targeting GI cancers.

Also during this time data may be reported from the ongoing MDACC clinical trial in myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) patients who previously failed or relapsed after hypomethylating agent therapy.