OGEN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-08

• On April 20, 2026, we announced that 2 patients and 8 study drug doses have been administered in our ongoing Phase IIa clinical trial evaluating ONP-002. Enrollment is progressing at Mackay Base Hospital in Queensland, Australia, the first activated site in the trial, with additional sites completin…

• Traumatic brain injury represents a significant neurological condition without an FDA-approved pharmacological treatment. According to the CDC, an estimated 1.7 to 3.8 million people in the U.S. experience traumatic brain injuries annually, with sports and recreational activities among the leading c…

• Our Phase IIa trial is designed to enroll 40 patients who meet enrollment criteria based on CT scan findings, presenting symptoms, and emergency room or hospital admission. Patients receive first dosing within 12 hours of concussion, followed by continued treatment for up to 30 days. We believe earl…

• Pre-clinical Animal Studies   Phase 1   Phase 2a clinical trials   U.S. based clinical trials   U.S. based additional clinical trials

• On May 7, 2026, we announced that we had entered into a Letter of Intent (“LOI”) under which we expect to license from Sigyn Therapeutics, Inc. (“Sigyn”) certain disease indications of CardioDialysis™, a blood purification technology that enables the broad-spectrum clearance of inflammatory and path…

Text removed vs the prior filing · source: 10-Q · 2025-11-07

• Pre-clinical Animal Studies   Phase 1   Phase 2a   Phase 2b   Phase 3

• Complete   Complete   Estimated Q4 2025 start   Estimated Q4 2026 start   Estimated Q4 2027 start

• In February 2025, we sold 260,000 shares pursuant to our ATM Agreement with Dawson James for net proceeds of $2.6 million. See Note 7 of Notes to Consolidated Financial Statements.

• On July 2, 2025, we completed a public offering of 660,000 shares of Series H Convertible Preferred Stock and 660,000 common stock warrants to purchase additional shares of Series H Convertible Preferred Stock, resulting in net proceeds of approximately $15.2 million. See Note 7 of Notes to Consolid…

• In March 2025, we issued a $3.0 million promissory note at a 17% original issue discount. After expenses, we received net proceeds of $2.2 million.

Text added vs the prior filing · source: 10-Q · 2026-05-08

• On March 14, 2026, the Company issued shares of its common stock at a price below the then-current conversion price of the Series H Preferred Stock. As a result, pursuant to the anti-dilution provisions contained in the Certificate of Designation, the conversion price of the Series H Preferred Stock…

• We might not be successful at acquiring, investing in or integrating businesses, entering into joint ventures or divesting businesses.

• We have undertaken, and expect to continue pursuing, strategic acquisitions, investments and joint ventures to enhance or add to our skills and capabilities or offerings of services and solutions, or to enable us to expand in certain geographic and other markets, such as our acquisition of our neuro…

• We may not be able to successfully consummate the transaction contemplated by the Sigyn Letter of Intent.

• On May 7, 2026, we announced that we had entered into a Letter of Intent (“LOI”) under which we expect to license from Sigyn Therapeutics, Inc. (“Sigyn”) certain disease indications of CardioDialysis™, a blood purification technology that enables the broad-spectrum clearance of inflammatory and path…