Nicox Provides Third Quarter 2024 update and First Half 2024 Financial Results

• Topline results from the NCX 470 (bimatoprost grenod) Phase 3 Denali clinical trial expected in Q3 2025
• Cash of €19.7 million on September 30, 2024, including the estimated net proceeds of the VYZULTA royalty sale and equity investment announced on October 14, 2024
• The Company estimates that it is financed into Q3 2025

October 17, 2024 – release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided the revenue and cash position for Nicox SA and its subsidiaries (the “Nicox Group”) for the third quarter of 2024 and financial results for Nicox SA (the “Company”) for the first half of 2024, as approved by the Board of Directors on October 16, 2024 and provided an update on key future milestones. As previously announced, the Company is no longer reporting consolidated accounts under IFRS standards and figures communicated for the Nicox Group are for information only.

“The first 9 months of 2024 have been a period of significant strategic progress for Nicox, in which we have stabilized our financial situation with a royalty sale, optimised our cost structure to focus on our lead asset and partnerships, renewed the Board of Directors and increased our institutional shareholder base through targeted financing activities. Our development team has also continued driving the NCX 470 Denali clinical trial with the completion of recruitment in the United States in July, and the target date for topline results now advanced to Q3 2025.” said Gavin Spencer, Chief Executive Officer of Nicox. “We have also seen major progress in our partnership activity, with our Chinese licensee Ocumension Therapeutics obtaining approval for ZERVIATE in China, where we are now awaiting the commercial launch, and the signature of a new research agreement, including a pre-agreed license option, for NCX 1728 with leading ophthalmic pharmaceutical and medical technology company Glaukos. Going forward we will be focussing on the completion of the Denali trial and partnerships for the commercialisation of NCX 470 in the United States and elsewhere.”

Key Future Milestones

• Launch of ZERVIATE in China by Nicox’s partner, Ocumension Therapeutics: Approval obtained in September 2024. 
• Whistler Phase 3b clinical trial, initiated in December 2023, investigating NCX 470’s dual mechanism of action (nitric oxide and prostaglandin analog) in intraocular pressure lowering: results are currently expected in the first quarter of 2025. 
• Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: recruitment of the last patient in the U.S. in the Denali trial was in July when overall recruitment was approaching the 95% level, with recruitment continuing in China and topline results are expected in Q3 2025. 

Management Change

Emmet Purtill, Vice President of Business Development at Nicox, has joined the Executive Committee. Emmet has been with the company since 2006 and has played a significant role in establishing our partnerships, notably the relationships with Ocumension and Kowa, and had led many of our recent deals. Emmet joins Sandrine Gestin, VP Finance and HR, Doug Hubatsch, Chief Scientific Officer and Gavin Spencer, Chief Executive Officer, who are the other Executive Committee members.

Revenue, Cash Position for the Nicox Group for the Third Quarter 2024 and post-period events

• Due to the sale of the VYZULTA royalty, the Nicox Group received no material revenue in the third quarter of 2024 compared to €1.8 million (net revenue¹ €1.1 million, entirely composed of net royalties) for the first quarter 2023.
• $16.5 million Royalty and Equity Financing with Soleus announced on October 14, 2024.
• Cash of €19.7 million at 30 September 2024 including the estimated net proceeds from the VYZULTA royalty sale and accompanying investment mentioned above, after deduction of legal, banking and other fees, compared to €7.7 million at 30 June 2024. Based on this cash position, expected milestone income from existing agreements, and accounting for the €5.2 million debt repayments by June 2025, the Company estimates that it is financed into Q3 2025. If any of the assumptions around estimated income or costs change, this may impact the cash runway of the Company. The Company cannot guarantee that it is financed to the topline results of the Denali trial, and completion of the Denali clinical trial may require additional financing.
• As of September 30, 2024, the Nicox Group had financial debt of €20.4 million (entirely held by Nicox SA), consisting of €19.4 million in the form of a bond financing agreement with Kreos Capital (an affiliate of BlackRock), and a €1.0 million credit agreement guaranteed by the French State, and granted in the context of the COVID-19 pandemic. Nicox will be repaying €5.2 million of the Kreos Capital debt by June 2025.
• The Company continues to evaluate all options for non-dilutive and dilutive financing to extend its cash runway. In particular the Company is actively exploring multiple strategic options which could facilitate the development and commercialization of its product candidate NCX 470 and the future growth of the Company.

First Half 2024 Financial Results for Nicox SA 

Net revenue¹ for the first half of 2024 was €4.9 million (including €1.7 million of net royalty payments and a license payment of €3.0 million) versus €1.7 million (consisting entirely of net royalty payments) for the first half of 2023.   

Operating expenses for the first half of 2024 were €10.1 million compared to €14.8 million for the first half of 2023. The decrease in operating expenses for the first half of 2024 compared with the first half of 2023 is explained by the costs related to the finalization of the Mont-Blanc study which had an impact on the first half of 2023. In addition, operating expenses for the first half of 2023 included a €3.5 million adjustment relating to the rebilling of services performed in 2022 by the U.S. subsidiary.

Net loss for the six months ended June 30, 2024, was €4.4 million, compared to a net loss of €12.5 million for the same period in 2023. The reduction in the net loss for the first half of 2024 is mainly due to the increase in revenues following the signature of the agreement with Kowa for Japan for which the Company has received an initial payment of €3 million, and to the reduction in operating expenses as explained above.

As of June 30, 2024, Nicox SA had cash and cash equivalents of €7.7 million as compared with €11.3 million as of December 31, 2023. Including the estimated net proceeds of the VYZULTA royalty sale and equity investment announced on October 14, 2024 and exclusively on the basis of the development of NCX 470, the Company estimates it is currently funded into Q3 2025.

As of June 30, 2024, Nicox SA had financial debt of €20.5 million, consisting of (i) €19.4 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and (ii) a €1.1 million credit agreement guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic.

Only the figure related to the cash position and the debt of Nicox SA as of December 31, 2023, is audited; all other figures in this press release are non-audited. 

Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index.

For more information www.nicox.com

H.C. Wainwright & Co Yi Chen New York, U.S.

Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2023” which is available on Nicox’s website (www.nicox.com).

Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.