DIMERx Preclinical Data Confirms DMX-101 Non-Addictive Profile: No Reinforcement, No Dependence

Key Regulatory Benchmark Met, Differentiating DMX-101 from Traditional Opioid Analgesics

Late-Breaking Results to be Presented at CPDD 2026 Annual Meeting

San Francisco, California–(Newsfile Corp. – May 12, 2026) –  DIMERx, Inc. (“DIMERx” or “the Company”) is a clinical-stage biopharmaceutical company dedicated to addressing the public-health crisis of drug misuse and dependence, with a portfolio of first-in-class, dimer-based pain therapeutics engineered to deliver effective analgesia without the addiction liabilities of conventional opioids. In June 2025, DIMERx was awarded a NIH HEAL Initiative grant to advance its DMX-101 program. The company today announced preclinical data confirming that DMX-101, an orally bioavailable, peripherally acting new chemical entity (NCE) dimer of buprenorphine, is free of the reinforcing effects that drive addiction to traditional opioids.

In a self-administration study conducted in accordance with FDA guidance, cocaine- and hydrocodone-trained rats demonstrated that DMX-101 produced no reinforcing behavior characteristic of opioid misuse and dependence. All compounds were administered intravenously to maximize pharmacological exposure, representing a worst-case scenario for misuse potential assessment. Notably, DMX-101 plasma exposure levels in rats were 18-fold higher than the maximum plasma concentration (Cmax) observed in humans following oral dosing, indicating that the absence of rewarding effects was demonstrated at exposures substantially exceeding those expected in clinical use. Even under these rigorous conditions, DMX-101 showed no evidence of addictive behavior, supporting a favorable safety profile with respect to misuse liability, overdose risk, and opioid-related morbidity.

“DMX-101 is designed to exclusively target peripheral opioid receptors, blocking pain signals at their source without engaging central nervous system pathways linked to reward, sedation, or addiction, and the absence of self-administration behavior observed in this study supports the potential for DMX-101 to provide effective pain relief without the risk of misuse,” said Virginia Sanders, PhD, Vice President of Preclinical and Principal Investigator for the NIH grant. “These results, together with prior preclinical and clinical findings, confirm our core hypothesis that peripherally restricted opioid modulation can deliver meaningful analgesia without the liabilities of traditional opioids. As the clinical and societal need for safer pain therapies intensifies, DMX-101 represents a differentiated approach to delivering meaningful analgesia without cognitive impairment or contributing to the addiction epidemic.”

“DMX-101 could redefine pain treatment. The absence of rewarding effects, even at exposures 18-fold above clinical levels, suggests we are looking at a genuinely differentiated therapy, one with the potential to displace traditional opioids and change the trajectory of the addiction crisis,” said Eric C. Strain, MD, Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University School of Medicine and an expert in addiction medicine and Scientific Advisor to DIMERx.

DIMERx will present these findings at the College on Problems of Drug Dependence (CPDD) 88th Annual Meeting, June 13-17, in Portland, OR. Virginia Sanders, PhD and Eric C. Strain, MD, will present the data.

Poster Details:

• Title: DMX-101 Does Not Exhibit Reinforcing Effects in a Hydrocodone-Trained Rat Self-Administration Model
• Session: Poster II
• Date/Time: Monday, June 15, 2026; 5:00pm-6:30pm
• Location: OCC, Level 1, Exhibit Hall A

About DIMERx, Inc.

DIMERx, Inc. is a clinical-stage biopharmaceutical company developing first-in-class, covalently linked dimer-based therapeutics to address major public-health challenges in pain management and the opioid crisis. Co-founded by CEO Nikhilesh Singh, M.Pharm, PhD, and CFO/COO Gregory Beyer, DIMERx is building a pipeline of innovative dimer-based candidates targeting pain and other serious conditions with high unmet medical need.

The company’s lead asset, DMX-101, is a covalently modified, chemically stable, halogen-free buprenorphine dimer (CAS No: 1820753-68-1) that acts peripherally at the source to provide non-addictive pain relief. DMX-101 is in phase 2 clinical development for chronic lower back pain. Across Phase 1 and Phase 2a studies involving over 400 subjects and patients, it has demonstrated a favorable safety profile, including pancreatic safety, and clear analgesic benefits. The DMX-101 program, which includes a planned human abuse liability study, is supported by a grant awarded by the National Institute on Drug Abuse (NIDA) under the NIH HEAL Initiative.

DIMERx’s second program, DMX-201, is a covalently linked dimer of arginine and agmatine, a next-generation nitric oxide (NO) donor being developed for conditions involving endothelial dysfunction, such as vaso-occlusive crisis (VOC) pain in sickle cell disease, where treatment options remain dominated by centrally acting opioids. Learn more at www.dimerx.com.

Funding Disclosure and Forward-Looking Statements

Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award number 1 UG3 DA061645-01A1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This press release may contain forward-looking statements, including information about management’s view of DIMERx (“the Company”), future expectations, plans and prospects. In particular, when used in the preceding discussion, the words “believes,” “expects,” “intends,” “plans,” “anticipates,” or “may,” and similar conditional expressions are intended to identify forward-looking statements. Any statements made in this presentation other than those of historical fact, about an action, event or development, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, which may cause the results of the Company, its subsidiaries and concepts to be materially different than those expressed or implied in such statements. Unknown or unpredictable factors also could have material adverse effects on the Company’s future results. The forward-looking statements included in this presentation are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, the Company undertakes no obligation to update these statements after the date of this release, except as required by law, and also takes no obligation to update or correct information prepared by third parties that are not paid for by DIMERx.

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