Oculis SA, European Biotech Acquisition Corp. announce business combination agreement

According to a news release, Oculis officials hope to forward product candidates to address areas of significant medical needs, including diabetic macular edema, dry eye disease, and neuro-retina indications such as glaucoma, affecting growing patient populations.

Oculis, SA and European Biotech Acquisition Corp. today announced they have entered into a definitive business combination agreement.

According to a news release, upon closing of the transaction, the company will be named Oculis Holding SA and will work to accelerate the development of Oculis’s differentiated ophthalmology pipeline.

The companies noted in the news release that the transaction includes commitments to an upsized PIPE and private investment of close to $80 million, anchored by LSP 7, with the participation of leading institutional investors, including Earlybird, Novartis Venture Fund, Pivotal bioVenture Partners, funds managed by Tekla Capital Management LLC, and VI Partners, among others.

According to Riad Sherif, MD, CEO of Oculis, the company’s mission is to drive innovation to save sight and improve eye care.

“This transaction accelerates our mission and propels our pipeline of highly differentiated product candidates for patients and physicians,” Sherif said in the news release. “We are delighted to have the support of key investors. We look forward to delivering important milestones including Phase 3 clinical trials of OCS-01, a potential first topical eyedrop product to treat the retina, Phase 2b clinical trials of OCS-02, a first in class topical anti-TNF for the treatment of DED and uveitis, and a proof-of-concept trial of neuroprotective agent, OCS-05, in acute optic neuritis. These are crucial deliverables towards bringing to market new therapies to patients.”

Moreover, Eduardo Bravo, CEO of EBAC, noted that Oculis has built a highly diversified late-stage pipeline that has the potential to change treatment in major ophthalmology segments.

“EBAC was formed to invest in the untapped potential in the European biotechnology sector and has screened over 100 European biotechnology companies,” he said in the news release. “Oculis is a prime example of what we set out to invest in, with great innovation, a well thought out strategy and an experienced management team to bring promising therapies to market for patients suffering from eye disease.”

Oculis’ product portfolio includes three clinical-stage product candidates:

  • OCS-01 was purposefully designed to enable a potential breakthrough approach in the treatment of retinal diseases; a topical, non-invasive approach. Current therapies require intra-ocular injections. Effective topical therapies would complement the existing approaches by adding an option with improved patient comfort, safety, accessibility, cost and allowing individualized dosing. OCS-01 combines dexamethasone, an approved active ingredient proven as effective and safe in the treatment of DME with a novel formulation technology that facilitates active ingredient access to the back-of-the-eye (Oculis’s Optireach technology). This product candidate is currently in Phase 3 development, globally (USA, EU, CN) for DME with the potential to become the first non-invasive, topical eye drop for a back of the eye disease. OCS-01 is also in Phase 3 development in the USA for the treatment of inflammation and pain following cataract surgery, which would, if approved, potentially be the first once-a-day steroid for this indication.
  • OCS-02 is a topical anti-TNF alpha monoclonal antibody fragment. The proprietary biologic technology of antibody fragment has potential pharmaceutical advantages in terms of solubility and stability. TNF alpha has been shown to be involved in two ophthalmic conditions: dry eye disease (DED) where it interferes with both core inflammation and necrosis and in uveitis where a TNF-alpha antagonist was approved as a systemic treatment of posterior uveitis. OCS-02 has completed three, placebo controlled, double masked, clinical studies in which favorable efficacy and tolerability results were observed: two in dry eye disease (DED) symptoms and one in acute anterior uveitis (AAU). The candidate is now progressing into Phase 2b clinical studies. For the treatment of DED, it has the potential to, if approved, be the first topical biologic, with an additional upside in personalized treatment based on a proprietary genetic biomarker. For the uveitis indication, the goal is to evaluate OCS-02 as a steroid-sparing maintenance treatment for chronic anterior uveitis, an indication where no other non-steroidal topical solutions are approved.
  • OCS-05 is a serum-glucocorticoid kinase 2 (SGK-2) activator, in development as a potential disease-modifying neuroprotective agent to address neurological damage to the optic nerve. OCS-05 is initially in development as a potential therapeutic for acute optic neuritis, or AON, a rare disease with high unmet need as currently, there is no approved treatment for AON. OCS-05 is currently in clinical studies in Europe. Oculis plans to evaluate OCS-05 to treat other pervasive ophthalmologic neurological pathologic disorders such as geographic atrophy, neuropathic keratitis and glaucoma.

In addition to these three clinical candidates, Oculis is engaged in several earlier preclinical development initiatives, including the evaluation of OCS-03 as a possible treatment for corneal neovascularization, a common disorder caused by the aberrant development of new blood vessels into the cornea and pterygium, a pink colored growth that originates in the conjunctiva. Oculis is also assessing the preclinical candidate OCS-04 as a potential therapeutic for use in corneal transplant.

Transaction overview
The business combination is expected to deliver gross proceeds to Oculis in excess of $200 million (assuming no redemptions). This includes approximately $127.5 million held in EBAC’s trust (assuming no redemptions) and commitments to an upsized PIPE and private investment of close to $80 million, anchored by LSP 7, with the participation of leading institutional investors, including Earlybird, Novartis Venture Fund, Pivotal bioVenture Partners, funds managed by Tekla Capital Management LLC, and VI Partners, among others.

The proposed transaction was unanimously approved by the board of directors of all parties and is supported by existing shareholders of Oculis.

The proposed transaction is expected to be completed in the first half of 2023, subject to, among other things, the approval by EBAC shareholders and the satisfaction or waiver of other customary closing conditions. The newly listed entity Oculis Holding SA will be a company registered in Switzerland with its headquarters at the current office of Oculis at the EPFL Innovation Park in Lausanne, Switzerland.

Oculis Advisors
BofA Securities is acting as financial advisor and SVB Securities is acting as capital market’s advisor to Oculis. Cooley (UK) LLP serves as US legal counsel, VISCHER SA serves as Swiss legal counsel and PricewaterhouseCoopers SA serves as auditors to Oculis, SA.

EBAC Advisors
Credit Suisse and Kempen are acting as financial advisor and capital markets advisor. Davis Polk & Wardwell LLP serves as U.S. legal counsel, Stibbe N.V. serves as Dutch legal counsel, and Maples Group serves as Cayman legal counsel to EBAC.

Credit Suisse, BofA Securities, SVB Securities, Kempen, and Arctica Finance are acting as private placements agents for EBAC in connection with the PIPE Transaction. Shearman & Sterling LLP serves as legal counsel to the placement agents.