Nicox Secures $16.5 Million Financing, Paving the Way for NCX 470 Development

Nicox SA, an international ophthalmology company, has announced a significant financing deal with Soleus Capital, a US-based life sciences investment firm. The agreement includes the sale of Nicox's net share of the VYZULTA royalty for $15 million, as well as a $1.5 million equity investment from Soleus. This transaction will provide Nicox with the necessary funding to advance its lead asset, NCX 470, through its pivotal Phase 3 Denali trial, with topline results now expected in Q3 2025.

Unlocking Value, Reducing Debt, and Securing the Future

Monetizing VYZULTA Royalties

Nicox has entered into a royalty purchase agreement with Soleus Capital, whereby Soleus will acquire Nicox's net share of the VYZULTA royalty for $15 million. VYZULTA, a prostaglandin analog with one of its metabolites being nitric oxide (NO), was the first eye drop approved in the past 20 years with a novel approach to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Exclusively licensed to Bausch + Lomb globally, VYZULTA has been commercialized in more than 15 countries, including the US, where it is covered by a composition of matter patent until 2029.

Debt Repayment and Reduced Burden

As part of the agreement, Nicox will make debt repayments of €5.2 million to its existing lender, Kreos Capital, by June 2025. This will significantly reduce the Company's debt burden, with the amortizable portion of the debt decreasing from €11.8 million to €6.6 million out of a total debt of €19.4 million. The interest rate on the outstanding debt will remain at 9.25%.

Securing Financing into Q3 2025

The combination of the VYZULTA royalty sale and the equity investment from Soleus is expected to finance Nicox into Q3 2025, providing the necessary runway to complete the Denali Phase 3 trial for NCX 470. The Company estimates that it is now financed until the topline results of the Denali trial, which are anticipated in Q3 2025.

Welcoming a New Strategic Investor

In addition to the royalty sale, Soleus is investing $1.5 million in Nicox shares, issued at a 20% premium to the closing price on October 11, 2024. The investment includes warrants valued at $0.75 million, with an exercise price of €0.5240 per share, representing a 100% premium to the closing price on the same date. This strategic investment from Soleus, a specialist life sciences investment firm, demonstrates their confidence in Nicox's future and the potential of its lead asset, NCX 470.

Strengthening Partnerships and Diversifying Revenue Streams

Nicox remains a late-stage clinical development company with revenue from ZERVIATE, expected to launch in China shortly, and strong partnerships with Glaukos, Ocumension, and Kowa. The Company is actively exploring additional strategic options to facilitate the development and commercialization of NCX 470 and drive the future growth of the business.

Accelerating the Denali Phase 3 Trial for NCX 470

NCX 470, Nicox's lead asset, is a novel nitric oxide-donating bimatoprost eye drop for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The Denali Phase 3 trial, which is currently underway in the US and China, has seen accelerated recruitment, with the last patient expected to be enrolled in the near future. As a result, the topline data from the Denali trial is now anticipated in Q3 2025, a significant advancement from the previous timeline.

Expanding the Reach of NCX 470

Nicox has secured strategic partnerships for the development and commercialization of NCX 470 in key markets. In China and Southeast Asia, the asset is partnered with Ocumension Therapeutics, who expects to be able to file a Chinese New Drug Application following the completion of the Denali trial. In Japan, NCX 470 is partnered with Kowa, where additional clinical trials will be required. Nicox retains 100% of the rights to NCX 470 outside of these regions, allowing the Company to explore further partnerships or direct commercialization in other markets.

Diversifying the Product Portfolio

In addition to the development of NCX 470, Nicox's product portfolio includes ZERVIATE, an eye drop for the treatment of allergic conjunctivitis, which is licensed to multiple partners, including Harrow, Inc. in the US and Ocumension Therapeutics in China and Southeast Asia. The upcoming launch of ZERVIATE in China, following its recent approval, is expected to provide Nicox with a new revenue stream to complement the potential future success of NCX 470.