Oculis Holding AG (OCS) News & EventsOCSOculis Holding AG

Oculis Acquires Accure's Privosegtor Rights

Oculis and Accure Therapeutics announced that Oculis and Accure have entered into an asset purchase agreement whereby, upon closing, Oculis will acquire all of Accure's worldwide development and commercial rights to Privosegtor. This acquisition will result in the termination of Oculis' existing license agreement with Accure, including associated milestone payments and royalties for each successful indication. This strategic transaction would enable Oculis to better harness Privosegtor's potential value going forward, without the encumbrance of the legacy license agreement with Accure, while retaining greater economic upside for the asset's future success as the company continues to drive Privosegtor's development and pursue potential expansion opportunities. Under the terms of the agreement, upon the first closing, Oculis will acquire Accure's rights to Privosegtor and, in a separate closing, ACT-02, an early-stage preclinical neurology drug candidate. Both closings are subject to separate conditions precedent, and the ACT-02 transaction closing is dependent upon the closing of the ACT-01 transaction. Total consideration for both transactions consists of an upfront payment of $3.8M in cash, to be paid to Accure at the first closing, and up to 2,050,000 Oculis ordinary shares to be issued to Accure. The Oculis ordinary shares consist of both upfront shares subject to lockup release over a period of up to 2 years following deal completion and earnout shares subject to vesting upon achievement of development and regulatory milestones related to the assets. Oculis expects to assume, for each asset, existing license agreements with academic institutions, which include obligations to pay low single-digit percentage royalties and to preserve the academic institutions' rights to use the assets for academic and non-commercial purposes, as required under Spanish law. The agreement has been approved by Oculis' board of directors, as well as the board of directors and shareholders of Accure. The closing for Privosegtor is expected to occur no later than February 28, 2027 and the closing for ACT-02 is expected to occur no later than March 31, 2027. The first registrational trial in the program, PIONEER-1, is evaluating Privosegtor in patients following an acute onset of ON in a broad population comprising patients with and without MS. PIONEER-1 clinical site activation is advancing as planned. Oculis also recently announced positive FDA pre-IND feedback supporting a regulatory pathway for Privosegtor in acute MS relapses, ahead of a planned IND submission in the fourth quarter.

Oculis CEO Highlights Privosegtor Neuroprotection Strategy

Riad Sherif, Chief Executive Officer of Oculis, stated, "We continue to advance and expand the Privosegtor neuroprotection franchise, with PIONEER-1 on track in global site activations and positive regulatory momentum supporting our development strategy in acute multiple sclerosis relapses. Given the considerable unmet need for neuroprotective treatments, these achievements reinforce both our strategy to pivot to neuro-ophthalmology by exploring the clinical potential of Privosegtor and the substantial opportunity across multiple neuro-ophthalmic and neuro-axonal diseases. In parallel, with Licaminlimab PREDICT-1 genotype-based trial planned site activations complete and over 45% of patients enrolled, we expect to report topline results around year-end. With a strong balance sheet, we are well positioned to execute on our strategy, advance our registrational programs and deliver on upcoming value-driving milestones."

Oculis Submits FDA Pre-IND Feedback for Privosegtor in Acute MS Relapses

Oculis announced FDA pre-IND feedback regarding Privosegtor's clinical development plan in acute multiple sclerosis relapses. Privosegtor is a peptoid small-molecule candidate with potential neuroprotective properties. In the previously completed Phase 2 ACUITY study, Privosegtor showed a clear neuroprotective effect in optic neuritis, improving visual function, preserving retinal ganglion cell layer integrity, and reducing neurofilament levels, a biomarker of axonal injury. Optic neuritis is frequently observed during new onsets of MS or as a typical relapse and serves as a well-established pathophysiological model that is generalizable to potentially all other acute MS relapses. The ACUITY study evaluated a broad population of patients with optic neuritis, including those with and without MS. The ACUITY study provided confidence to investigate Privosegtor in the ongoing PIONEER global registrational program for optic neuritis. Expanding into acute MS relapses is an evolution for the Privosegtor program. Oculis requested pre-IND feedback from the FDA to guide its development plans with Privosegtor for a potential new indication in acute MS relapses. The FDA Division of Neurology provided guidance that Oculis could cross-reference data from the open IND and that no additional preclinical studies are required for an IND submission in acute MS relapses. The FDA feedback also supported the proposed clinical development strategy and regulatory pathway, which will include MS patients with both optic neuritis and other relapses, such as ambulatory relapses, in future trials. It also supported a primary endpoint as early as three months, with the same 3mg/kg dose administered daily for 5 days as in PIONEER-1. Oculis anticipates an IND submission for the treatment of acute MS relapses in the fourth quarter of 2026.