Seclidemstat mesylate

Decoy’s development of novel peptide-conjugate therapeutics arising from its proprietary IMP3ACT™ platform to benefit from Dr. Langer’s extensive scientific knowledge and experienceCAMBRIDGE, Mass. and HOUSTON, April 16, 2025 (GLOBE NEWSWIRE) -- Decoy Therapeutics, Inc. (Decoy), a privately held preclinical biopharmaceutical company engineering the next generation of peptide conjugate therapeutics, announces that Massachusetts Institute of Technology (MIT) Professor and Moderna co-founder Robert S. Langer, ScD will join the company’s Scientific Advisory Board (SAB) upon the successful completion of Decoy’s merger with Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX). As announced on January 13, 2025, Decoy and Salarius Pharmaceuticals signed a definitive agreement under which Decoy Therapeutics will merge with a wholly owned subsidiary of Salarius Pharmaceuticals, with the newly formed company to be named Decoy Therapeutics. Dr. Langer is a world-renowned scientist, entrepreneur and biotechnology visionary. His groundbreaking work in drug delivery systems design and in tissue engineering have earned him numerous awards, including the prestigious National Medal of Science and the Charles Stark Draper Prize. Drug development technologies that Dr. Langer pioneered have laid the foundations for transformative medicines including Roche’s cancer drug bevacizumab (Avastin®) and Moderna's Spikevax® mRNA Covid vaccine. "It’s an honor to have Dr. Langer join our SAB,” commented Michael M. Lipp, PhD, Chief Technology Officer of Decoy. “Having worked in Dr. Langer’s lab and at start-up companies that were founded on innovations arising from his lab, I’ve seen first-hand the impact he brings in discovering transformational therapies and advancing their development. We are confident that Dr. Langer’s tremendous experience and know-how will provide invaluable support as we use our proprietary IMP3ACT platform to advance a portfolio of proprietary peptide-conjugate products.” “Decoy is utilizing an innovative, next-generation peptide-conjugate platform to discover and develop much-needed and differentiated antiviral and cancer therapies,” said Dr. Langer. “I am excited to collaborate with the Decoy team and to lend my expertise to expedite the development of these potentially high-impact therapeutics.” “We are thrilled Dr. Langer has agreed to join our SAB thus expanding our thought leadership,” added Shahin Gharakhanian, MD, acting Chief Medical Officer and SAB Chair of Decoy. “We look forward to synergizing his guidance with our current SAB members and incorporating his drug design perspectives, particularly calling upon his expertise in developing dosage forms and routes of administration for Decoy’s peptide-conjugate drugs.” Dr. Langer is one of nine Institute Professors at MIT, the institution’s highest faculty honor, and is a faculty member of the Harvard-MIT program in Health Sciences and Technology. His pioneering work has benefited millions of people worldwide and includes isolating the first angiogenesis inhibitors (with Dr. Judah Folkman) leading to new treatments for cancer and blindness. He also created the first nanoparticles and microparticles for delivering large molecules including nucleic acids, and helped establish the field of tissue engineering, which enabled artificial skin for burn victims and organ-on-a-chip technology. Dr. Langer has authored more than 1,600 scientific papers with more than 444,000 citations, making him the most-cited biological engineer in history. His patents have been licensed or sublicensed to over 400 companies and he has co-founded more than 40 ventures. Dr. Langer chaired the FDA’s Science Board from 1999–2002. He has received more than 220 awards and is one of only three living individuals to receive both the U.S. National Medal of Science and the National Medal of Technology and Innovation. His accolades include the Draper Prize, the Queen Elizabeth Prize for Engineering, the Albany Medical Center Prize, the Breakthrough Prize in Life Sciences, the Kyoto Prize, the Wolf Prize in Chemistry, the Millennium Technology Prize and the Kavli Prize in Nanoscience. He holds 44 honorary doctorates from institutions including Harvard University, Yale University, Columbia University and the University of Oxford, and has been elected to the National Academies of Medicine, Engineering and Sciences, as well as the National Academy of Inventors. About Decoy’s Peptide Conjugate Technology Decoy’s drug design engine uses the power of computational tools and fast peptide synthesis technology pioneered in the laboratory of Brad Pentelute, Ph.D., Professor of Chemistry at MIT and Decoy co-founder, to rapidly engineer and synthesize novel antivirals that directly target highly conserved viral machinery. Its proprietary IMP3ACT peptide conjugate drug design and manufacturing platform leverages machine learning and artificial intelligence (AI) tools. IMP3ACT allows for the rapid computational design and manufacturing of innovative peptide-conjugate therapeutics including rapid response to novel viral pathogens including H5N1 avian flu. Peptide conjugates are a new class of drug, perhaps best known for the popular diabetes and weight loss medications, that takes advantage of the strong activity and selectivity of peptides, and improves their targeting and durability by adding a lipid molecule. Decoy Therapeutics is expanding the use of this new drug class to indications including infectious diseases and cancer. The IMP3ACT platform leverages peptide chemistry to design a-helical peptides using computational and machine learning tools. These peptides are transformed into multimeric conjugates by chemically linking a defined number of copies to lipids or other suitable membrane anchor moieties, enhancing their drug-like properties and dosing flexibility with extended pharmacokinetics. Decoy’s technology has produced peptide conjugates effective in vitro against multiple human coronaviruses, including all SARS-CoV-2 major variants of concern to date, and against RSV A, RSV B and hPIV3, and in vivo against the SARS-CoV-2 delta variant. By integrating machine learning algorithms in peptide design and synthesis, Decoy’s platform accelerates the creation of lead molecules for preclinical evaluations, simultaneously optimizing peptide conjugates for enhanced affinity, binding specificity, resistance to proteases, pharmacokinetic properties and manufacturability at early commercial scale. About Decoy Therapeutics, Inc. Decoy Therapeutics is a preclinical-stage biotechnology company that is leveraging machine learning and artificial intelligence tools alongside high-speed synthesis techniques to rapidly design, engineer and manufacture peptide-conjugate drug candidates that target serious unmet medical needs. The company’s initial pipeline is focused on respiratory viruses and GI cancers. Decoy has attracted financing from institutional investors as well as significant non-dilutive capital from the Massachusetts Life Sciences Seed Fund, the Google AI startup program and the NVIDIA Inception program among other sources. The company has also received QuickFire Challenge award funding provided by the Biomedical Advanced Research and Development Authority (BARDA) through BLUE KNIGHT™, a collaboration between Johnson & Johnson Innovation – JLABS and BARDA within the Administration for Strategic Preparedness and Response. For more information, please visit www.DecoyTx.com. About Salarius Pharmaceuticals, Inc. Salarius Pharmaceuticals is a clinical-stage biopharmaceutical company with two drug candidates for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, the company’s lead candidate, which is being studied in an investigator-initiated Phase 1/2 clinical study in hematologic cancers underway at MD Anderson Cancer Center as a potential treatment for MDS and CMML in patients with limited treatment options. SP-3164, the company’s IND-stage second asset, is an oral small molecule protein degrader. Salarius previously received financial support for seclidemstat for the treatment of Ewing sarcoma from the National Pediatric Cancer Foundation and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit www.salariuspharma.com. About the Proposed Transaction Definitive agreements were executed with unanimous approvals by the Boards of Directors of Salarius and Decoy. The closing consideration will consist primarily of nonvoting preferred stock of Salarius, and it is expected that following closing and a post-closing stockholder vote to approve the conversion of the preferred shares into common stock, Decoy investors would own approximately 86% of the outstanding shares of the merged company and Salarius stockholders would own approximately 14% of the outstanding shares, in each case exclusive of any shares issued in any financing, including the qualifying financing(s) necessary to consummate the merger transaction. For further details on the transaction and conditions for closing of the merger, please refer to the Form 8-Ks Salarius filed with the U.S. Securities and Exchange Commission (SEC) on each of January 13, 2025 and March 8, 2025 at www.sec.gov. Non-Solicitation This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No public offer of securities in connection with the merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding Salarius, Decoy, the proposed merger and other matters, including without limitation, statements relating to plans and expectations relating to the business, scientific advisory board, products, including expected achievement of milestones for its lead asset and future prospects of Decoy and the combined company. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Salarius, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the risk that the conditions to the closing are not satisfied, including uncertainties as to the timing of the consummation of the proposed merger; the ability of each of Salarius and Decoy to consummate the merger; risks related to Salarius’ ability to estimate and manage its operating expenses and its expenses associated with the proposed merger pending the closing; risks that the combined company will not achieve the synergies expected from the proposed merger; risks that Salarius and the combined company will not obtain sufficient financing to execute on their business plans and risks related to Decoy’s products and development plans, including unanticipated issues with any IND application process and the potential of the IMP3ACT™ platform. Readers are urged to carefully review and consider the various disclosures made by Salarius in its reports filed with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, Salarius’ actual results may vary materially from those expected or projected. CONTACTS: Decoy Therapeutics, Inc.Rick Pierce, CEOPierce@decoytx.com617-447-8299 Business Development:Peter Marschel, CBOPeter@Decoytx.com617-943-6305 Salarius Pharmaceuticals, Inc.Alliance Advisors IRJody Cainjcain@allianceadvisors.com310-691-7100

Decoy’s proprietary IMP3ACT™ peptide conjugate drug design and manufacturing platform leverages machine learning (ML) and artificial intelligence (AI) tools Decoy is leveraging non-dilutive funding and equivalents from federal governments, corporations and The Bill & Melinda Gates Foundation totaling approximately $7 million Combined company expects to accelerate clinical development of novel peptide conjugate therapeutics for the treatment of respiratory viruses and cancer Jan. 13, 2025 -- Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options, and Decoy Therapeutics, Inc., a privately held preclinical biopharmaceutical company engineering the next generation of peptide conjugate therapeutics, announce the signing of a definitive agreement 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, M.D., 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, Mr. 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. Mr. 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.” 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. Definitive agreements were executed with unanimous approvals by the Boards of Directors of Salarius Pharmaceuticals and Decoy Therapeutics. The closing consideration will consist primarily of nonvoting preferred stock of Salarius, and it is expected that following closing and a post-closing stockholder vote to approve the conversion of the preferred shares into common stock, Decoy investors would own approximately 86% of the outstanding shares of the merged company and Salarius stockholders would own approximately 14% of the outstanding shares, subject to adjustment, in each case exclusive of any shares issued in any subsequent financing. For further details on the transaction and conditions for closing of the merger, please refer to the Form 8-K Salarius Pharmaceuticals filed with the U.S. Securities and Exchange Commission (SEC) in conjunction with this press release at www.sec.gov. Canaccord Genuity is serving as exclusive strategic advisor to Salarius, and Hogan Lovells US LLP and Honigman LLP are serving as legal counsel. Ladenburg Thalmann is serving as financial advisor to Decoy, and Nason, Yeager, Gerson, Harris & Fumero, P.A. is serving as legal counsel. Decoy Therapeutics is a preclinical-stage biotechnology company that is leveraging machine learning and artificial intelligence tools alongside high-speed synthesis techniques to rapidly design, engineer and manufacture peptide conjugate drug candidates that target serious unmet medical needs. The company’s initial pipeline is focused on respiratory viruses and GI cancers. Decoy has attracted financing from institutional investors as well as significant non-dilutive capital from the Bill & Melinda Gates Foundation, the Massachusetts Life Sciences Seed Fund, the Google AI startup program and the NVIDIA Inception program. The company has also received QuickFire Challenge award funding provided by BARDA through BLUE KNIGHT™, a collaboration between Johnson & Johnson Innovation – JLABS and the Biomedical Advanced Research and Development Authority within the Administration for Strategic Preparedness and Response. For more information, please visit www.DecoyTx.com. Salarius Pharmaceuticals is a clinical-stage biopharmaceutical company with two drug candidates for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, the company’s lead candidate, which is being studied in an investigator-initiated Phase 1/2 clinical study in hematologic cancers underway at MD Anderson Cancer Center as a potential treatment for MDS and CML in patients with limited treatment options. SP-3164, the company’s IND-stage second asset, is an oral small molecule protein degrader. Salarius previously received financial support for seclidemstat for the treatment of Ewing sarcoma from the National Pediatric Cancer Foundation and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). The content above comes from the network. if any infringement, please contact us to modify.