Nicox publishes first-half 2022 business and financial results update

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  • Topline results of ffirst phase pivot 3 glaucoma clinical test on NCX 470montblanc, due In november 2022

  • Report revent 1.4 million for H1 2022; cash of €31.6 million as of June 30, 2022

September 16, 2022 – release at 7:30 am CET
Sophia-Antipolis, France

Nicox S.A. (Euronext Paris: FR0013018124, COX), an international ophthalmology society, today announced the commercial and financial results of Nicox SA and its subsidiaries (the “Nicox Group”) for the first half of 2022.

I joined Nicox because I saw the potential for NCX 470 will be the first true successor to the first prostaglandin analog approved for lowering intraocular pressure, Xalatan, which I launched while at Pharmacy. Ssubstantial progress was done this year with the completion of enrollment in the pivotal Phase 3 Mont Blanc trial for our lead asset, NCX 470, targeting glaucoma, and Wwe are just weeks away from results of the first of the of them Phase 3 trials. Jthose data, due in November, could to bring the corner stone for build the future of the company,” said Andreas Segerros, Managing Director of Nicox. “The NCX 470 has already demonstrated a statistically significant improvement over the standard of care for lowering intraocular pressure, latanoprost, in a robust phase 2 clinical trial. We have also demonstrated beneficial effects in anot live damage model to optic nerve head and retina. We to believe youhe In progress Phase 3 program will demonstrate the potential of NCX 470 as the best treatment for glaucoma, meet a major need in thalmost is $6 billion worldwide market, and wWe are delighted to see these results.

Andreas Segerros continued, “During my first months here, I discovered a very strong focused on ophthalmology The R&D team, which we have since completed with excellent new recruits, supported by an experienced teamcompetent, Corporate, financial and legal organization. I am pleased to have rejoined Nicox at such an important time in of the company the story. After looking at the wallet, I to believe we are well positioned to leverage the strength of the NCX 470 program by potentially to advance our novel nitric oxide donor phosphodiesterase-5 inhibitor, CNX 1728and through the opportunistic adding others programs in developmenteline.

NCX 470 data presented to date has the potential to significantly impact the glaucoma treatment paradigm.” said Dr. Robert Weinreb, Emeritus Professor and Chair of Ophthalmology at the UNUniversity of CaliforniaSan Diego, and a member of the Nicox Glaucoma Clinical Advisory Board“.

First semester 2022 Company Update

  • Andreas Segerros joined Nicox as Chief Executive Officer on June 1, 2022. He brings significant pharmaceutical and venture capital expertise, including in ophthalmology, notably as Global Head of Ophthalmology at Pharmacia, where he launched XALATAN® (latanoprost), making it the industry’s first billion-dollar eye drug.

  • With the appointment of Andreas Segerros as CEO, the role was separated from that of Chairman. Jean-François Labbé, director and chairman of the audit committee, has been appointed chairman of the board of directors of Nicox SA, with effect from July 28, 2022.

  • NCX470, Nicox’s lead clinical product candidate, is a novel, potentially best-in-class, nitric oxide (NO)-donating prostaglandin analog eye drops currently in a Phase 3 program for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma syndrome or ocular hypertension. The first results of the first phase 3 clinical trial, Mont Blanc, are expected in November. Positive results from the Dolomites Phase 2 clinical trial of NCX 470 were reported in October 2019.

  • Patient recruitment continues in the United States (US) and China for the ongoing Denali Phase 3 clinical trial in NCX470 in patients with open-angle glaucoma or ocular hypertension. The Denali trial is jointly conducted and funded equally with our Chinese partner, Ocumension Therapeutics. Based on current hiring rates, the company expects higher results after 2024. The timeline has been impacted by COVID-19, particularly the lockdown in China, and longer-term environmental effects broader clinical trials in glaucoma.

  • NCX4251 is a new patented ophthalmic suspension of fluticasone propionate nanocrystals for dry eye. The Company is currently seeking partnerships outside of China to advance the development of this program. NCX 4251 is licensed exclusively to Ocumension Therapeutics in the Chinese market.

  • VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, is now approved in 18 markets, including approval in Lebanon in the second quarter of 2022. After a launch in Thailand in the second quarter of 2022, it is now marketed in 8 territories, and a launch in Brazil is expected in the fourth quarter of this year. VYZULTA is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension.

Financial for the first half of 2022 Results

As of June 30, 2022, the Nicox group had cash and cash equivalents of €31.6 million, compared to €35.1 million as of March 31, 2022 and €42.0 million as of December 31, 2021. Company estimates to be funded in Q4 2023, based on development of NCX 470 alone, and assuming expansion1 the interest-only period of Kreos’ existing debt.

As of June 30, 2022, the Nicox group had financial debt of €20.6 million comprising €18.6 million in the form of a bond financing with Kreos Capital signed in January 2019 and a €2.0 million loan guaranteed by the French State in August 2020 in the context of the COVID-19 pandemic.

Net revenue2 for the first half of 2022 was €1.4 million (including €1.3 million in fees) compared to €1.3 million (including €1.2 million in fees) for the first half of 2021.

Operating expenses for the first half of 2022 amounted to €12.7 million compared to €13.4 million in the first half of 2021.

The Nicox Group recorded a net loss of €17.0 million during the six months ended June 30, 2022, compared to a net loss of €11.7 million for the same period in 2021. The net loss of the first half of 2022 includes €11.1 million of non-recurring charges. , non-cash items due to the decision to seek a partner to pursue the development of the NCX 4251 in the USA

Only the figure relating to the Nicox group’s cash position as of December 31, 2021 is audited; all other figures in this press release are unaudited.

Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve eye health. Nicox’s lead clinical development program is NCX 470, a novel nitric oxide-donating prostaglandin analog intended to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The company is also researching NCX 1728, a nitric oxide-donating phosphodiesterase 5 inhibitor, in lowering intraocular pressure and retinal conditions. NCX 4251, a new patented ophthalmic suspension of fluticasone propionate nanocrystals for topical ocular application for dry eye, is being developed by Ocumension Therapeutics in China under an exclusive license agreement and is available for partnership elsewhere . Nicox derives revenue from VYZULTA® in glaucoma, under exclusive worldwide license to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including Eyevance Pharmaceuticals, LLC (a wholly owned subsidiary of Santen Pharmaceutical Co., Ltd.), in the United States and Ocumension Therapeutics in China and most markets from Southeast Asia.

Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indices.

For more information about Nicox, its products or its pipeline, please visit: www.nicox.com.

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