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Nicox provides updates for the third quarter of 2024 and the first half of the year

Nicox provides updates for the third quarter of 2024 and the first half of the year

  • Key results from the Phase 3 Denali clinical trial of NCX 470 (Bimatoprost Grenod) are expected in the third quarter of 2025
  • Cash of EUR 19.7 million as of September 30, 2024, including the estimated net proceeds from the VYZULTA license sale and the equity investment announced on October 14, 2024
  • The company expects the financing to be completed by the third quarter of 2025

October 17, 2024 – Published at 7:30 a.m. ET
Sophia Antipolis, France

Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced the third quarter 2024 revenue and liquidity position for Nicox SA and its subsidiaries (the “Nicox Group”) and financial results for Nicox SA (the “Companies”) ) for the first half of 2024, as approved by the Board on October 16, 2024 and provided an update on key future milestones. As previously announced, the company no longer reports consolidated financial statements in accordance with IFRS standards and the figures provided for the Nicox Group are for informational purposes only.

“The first 9 months of 2024 have been a period of significant strategic progress for Nicox, during which we have stabilized our financial situation through a license sale, optimized our cost structure to focus on our core asset and partnerships, renewed the Board of Directors and expanded our institutional shareholder base through targeted financing activities. Our development team has also continued to advance the NCX 470 Denali clinical trial, with enrollment in the United States completed in July and the target date for topline results now advanced to the third quarter of 2025.” said Gavin Spencer, Chief Executive Officer of Nicox. “We have also seen great progress in our partnership activity: our Chinese licensee Ocumension Therapeutics received approval for ZERVIATE in China, where we are now awaiting commercial launch, and the signing of a new research agreement, including a pre-agreed licensing option. for NCX 1728 with Glaukos, the leading pharmaceutical and medical technology company for ophthalmology. Going forward, we will focus on completing the Denali test and partnering to commercialize NCX 470 in the United States and elsewhere.”

Important future milestones

  • Introduction of ZERVIATE in China by Nicox’s partner Ocumension Therapeutics: Approval granted in September 2024.
  • Phase 3b clinical trial in Whistler, initiated in December 2023, examines the dual mechanism of action of NCX 470 (nitric oxide and prostaglandin analogue) in reducing intraocular pressure: 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: Enrollment of the final U.S. patient in the Denali trial occurred in July, when overall enrollment neared the 95% level. Recruitment continues in China and topline results are expected in the third quarter of 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 an important role in building our partnerships, particularly with Ocumension and Kowa, and has been responsible for many of our recent deals. Emmet joins Sandrine Gestin, VP Finance and HR, Doug Hubatsch, Chief Scientific Officer, and Gavin Spencer, Chief Executive Officer, as other members of the Executive Committee.

Sales, cash position of Nicox Group for the third quarter of 2024 and events after the reporting period

  • Due to the sale of the VYZULTA royalty, the Nicox Group did not generate significant revenues in the third quarter of 2024 compared to 1.8 million euros (net sales).1 €1.1 million, consisting entirely of net royalties) for the first quarter of 2023.
  • On October 14, 2024, $16.5 million in royalty and equity financing with Soleus was announced.
  • Cash of EUR 19.7 million as of September 30, 2024, including the estimated net proceeds from the VYZULTA license sale and the above-mentioned accompanying investments, after deducting legal, banking and other fees, compared to EUR 7.7 million as of June 30, 2024. Based on this cash position, the expected milestone revenues from existing agreements and taking into account the debt repayments of EUR 5.2 million by June 2025, the company expects the financing to last until the third quarter of 2025. If assumptions about estimated revenues or costs change, this could affect the company’s liquidity. The Company cannot guarantee that funding will be consistent with the topline results of the Denali Study, and completion of the Denali clinical trial may require additional funding.
  • As of September 30, 2024, the Nicox Group had financial debt of 20.4 million euros (fully held by Nicox SA), consisting of 19.4 million euros in the form of a bond financing agreement with Kreos Capital (a subsidiary of BlackRock) and a Loan agreement for 1.0 million euros guaranteed by the French State and granted in connection with the COVID-19 pandemic. Nicox will repay 5.2 million euros of Kreos Capital’s debt by June 2025.
  • The Company continues to explore all non-dilutive and dilutive financing options to expand its cash reserves. In particular, the Company is actively evaluating several strategic options that could facilitate the development and commercialization of its NCX 470 product candidate and the Company’s future growth.

First half 2024 financial results for Nicox SA

Net sales1 for the first half of 2024 they were 4.9 million euros (including 1.7 million euros of net license payments and a license payment of 3.0 million euros) compared to 1.7 million euros (comprising entirely of net license payments) for the first half of 2023.

Operating expenses amounted to 10.1 million euros in the first half of 2024 compared to 14.8 million euros in the first half of 2023. The decrease in operating expenses in the first half of 2024 compared to the first half of 2023 is explained by the costs associated with completing the Mont Blanc study that impacted the first half of 2023. In addition, operating expenses for the first half of 2023 included an adjustment of 3.5 million euros related to the rebilling of services provided by the US subsidiary in 2022.

The net loss for the six months ended June 30, 2024 was 4.4 million euros, compared to a net loss of 12.5 million euros for the same period in 2023. The decrease in net loss for the first half of 2024 is mainly due to the increase in sales following the signing of the agreement with Kowa for Japan, for which the company received an initial payment of 3 million euros, and to the reduction in operating costs explained above.

As of June 30, 2024, Nicox SA had cash and cash equivalents of EUR 7.7 million compared to EUR 11.3 million as of December 31, 2023. Including the estimated net proceeds from the VYZULTA license sale and those on October 14, 2024 announced equity investment and based solely on the performance of NCX 470, the company currently expects funding to extend through the third quarter of 2025.

As of June 30, 2024, Nicox SA had financial debt of 20.5 million euros, consisting of (i) 19.4 million euros in the form of a bond financing agreement with Kreos Capital signed in January 2019 and (ii) a credit agreement of 1, 1 million euros guaranteed by the French State and granted in August 2020 in the context of the COVID-19 pandemic.

Only the figure relating to Nicox SA’s cash balance and debt as of December 31, 2023 is audited; All other figures in this press release are unaudited.