Crown Point, IN – December 16, 2025 — OYE Therapeutics, a clinical-stage pharmaceutical company developing a caffeine platform for anesthesia recovery and opioid-induced respiratory depression (OIRD), announced that on November 28, 2025 it had raised $5.475 million in a Series A financing. OYE Therapeutics proprietary product, comprised high-concentration caffeine expects to begin a Phase 1 clinical trial Q1 2026. WBB Securities LLC acted as the placement agent for this transaction.
In the drug overdose setting, OYE Therapeutics intends for its investigational product to be used in combination with naloxone. The rationale is that naloxone, an opioid antagonist, temporarily blocks the life-threatening effect from an opioid overdose, while the high-concentration caffeine, a central nervous system stimulant, allows patients to remain awake longer and breathe more consistently in recovery.
“OIRD remains a leading cause of serious adverse events in clinical and emergency care, and our approach seeks to provide clinicians with an additional tool to support respiratory function when opioids are administered,” said Brett Dines, RPh, MBA, Chief Executive Officer and Founder of OYE Therapeutics. “With this funding, we have the resources to complete our IND, expand our CMC activities, advance our lead candidate into the clinic, and ultimately generate our first clinical data for 505(b)(2) submission.”
The phase 1 trial will be focused on evaluating the pharmacokinetics, safety, tolerability and efficacy of its intravenous high-concentration caffeine candidate. The first phase will evaluate the product in healthy volunteers while the second phase will evaluate patients with simulated fentanyl intoxication. Results from this trial will inform subsequent studies.
The company’s development strategy builds on preclinical and translational work showing that optimized caffeine formulations can be delivered intravenously at concentrations suitable for acute care settings. By improving caffeine solubility and delivery, the formulation aims to enhance central nervous system stimulation and respiratory drive in settings where standard supportive care may be insufficient.
In addition to the planned OIRD indication, the company has received a grant from the US Military to develop a product to assist rapid recovery in defense and civilian medicine (Dual use). OYE is also pursuing clinical development in general anesthesia recovery, where accelerated emergence and improved post-anesthesia respiratory and cognitive function could help address unmet needs in perioperative medicine.
