COX Nicox SA

Nicox's Shareholder Letter

Nicox's Shareholder Letter

Dear Shareholder,

The upcoming Extraordinary General Meeting, which will take place on April 10, is of particular importance for Nicox. I am writing to you today, in my capacity as the new Chief Executive Officer, in order to share the latest information with you and request your participation in this meeting, as your support is essential to provide the Company with new momentum. It is an honor to have the trust of the Board of Directors in appointing me CEO of Nicox. Many of you know me personally, as I have been part of the company for nearly 20 years.

As such, I have been involved in closing many of our partnership agreements, and also in financing agreements. Today, our priority is to focus on the potential of NCX 470 and the completion of our second pivotal Phase 3 study in glaucoma, and I am looking forward to strengthening the Company's relationship with its shareholders.

Nicox is a biotech company with revenue and a late-stage de-risked asset which has future strategic value, some of which is already recognized in partnerships with leading companies, and strong in-house corporate and therapeutic area expertise. This is a strong profile for a company in our sector. Our first Phase 3 clinical trial on NCX 470, Mont Blanc, demonstrated that we have an approvable product with the U.S. Food and Drug Administration (FDA), and this is now within reach, assuming that the results of the ongoing Denali Phase 3 trial replicate those of Mont Blanc.

We received the positive Mont Blanc trial data in late 2022 in a very difficult market environment, which is one of the factors that has affected the stock price of Nicox. The slowdown in biotech funding in Europe, between mid-2021 and today, has been one of the longest and most significant.

There are now increasing signs of optimism: the market is reigniting in the U.S. as we speak and the same trend is slowly emerging in Europe. For the first time in a few years, there is a noticeable positive energy around industry events, and we continue to receive encouraging feedback on Nicox’s approach and our product candidates.

We already have strong collaborations and partners for NCX 470 in the key markets of China and Japan, with Ocumension Therapeutics and Kowa respectively. The Japanese agreement, concluded in February, is an important further validation of the interest in NCX 470 as a new medicine.

The Denali trial, run in collaboration with our long-term Chinese partner Ocumension Therapeutics, is on track with 80% of the target number of patients already randomized and we expect topline results in H2 2025. The data will crystallize the profile of NCX 470 and ensuring we can complete Denali will allow us to consider strategic options for the Company and routes to commercialization outside of our existing partnerships. We continue to keep potential licensing and strategic partners informed of the progress in Denali, as part of advancing these discussions.

We estimate peak net annual sales of NCX 470 at over $300 million and given the significant potential value for Nicox, we are fully focused on this product candidate. The Development team is concentrating on completing the Denali trial, and all associated studies and data generation needed for the New Drug Application in the U.S. and China. The Corporate team remains focused on extending the cash runway to allow the Company to complete that trial and identifying a U.S. commercial partner.

The upfront payment from Kowa, together with the restructuring of our debt with BlackRock, has extended our cash runway to November 2024, according to our latest estimate. Along with actions we have recently taken to reduce our operating costs to focus on completing the Denali trial, we require further financing to continue to meet the requirements of the debt restructuring, and through 2025 to advance NCX 470 clinical development. We are considering all options and are in a number of business development discussions which could provide non-dilutive capital. We also plan to return to the equity capital markets, for which we need to renew the financing resolutions at our upcoming Extraordinary General Meeting.

I therefore ask you to attend this Extraordinary General Meeting, which has been convened for April 10 (and for May 6 if a second event is needed) and to vote in favor of the resolutions. You will find the information pertaining to the meeting on our website at .

I thank you for your continued support as a shareholder, as we aim to deliver on our strategy to unlock the potential value in Nicox and NCX 470. I look forward to your support for our next steps.

Yours sincerely,

Gavin Spencer

Chief Executive Officer

 

Attachment



EN
22/03/2024

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Reports on Nicox SA

 PRESS RELEASE

Nicox Highlights Positive NCX 470 Phase 3 Data Confirming Therapeutic ...

Nicox Highlights Positive NCX 470 Phase 3 Data Confirming Therapeutic Profile at the 2026 American Glaucoma Society Annual Meeting Press Release Nicox Highlights Positive NCX 470 Phase 3 Data Confirming Therapeutic Profile at the 2026 American Glaucoma Society Annual MeetingFebruary 24, 2026 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that positive data from the NCX 470 Phase 3 studies were highlighted in 2 podium presentations and a poster at the 2026 American Glaucoma Societ...

 PRESS RELEASE

Nicox présente des données de Phase 3 positives confirmant le profil t...

Nicox présente des données de Phase 3 positives confirmant le profil thérapeutique de NCX 470 lors du congrès annuel 2026 de l’American Glaucoma Society (AGS) Communiqué de presseNicox présente des données de Phase 3 positives confirmant le profil thérapeutique de NCX 470 lors du congrès annuel 2026 de l’American Glaucoma Society (AGS) 24 février 2026 – publication à 7H30Sophia Antipolis, FranceNicox SA (Euronext Growth Paris : FR0013018124, ALCOX, éligible PEA-PME), une société internationale spécialisée en ophtalmologie, annonce aujourd’hui que les données positives issues des études de p...

 PRESS RELEASE

Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA f...

Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470 Press Release Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470 U.S. NDA submission on track for summer 2026Nicox to receive milestone payment from Kowa upon submission of the NDANDA submission based on Phase 3 clinical data showing NCX 470 lowered intraocular pressure by up to 10mmHg in patients with open-angle glaucoma or ocular hypertension February 16, 2026 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international...

 PRESS RELEASE

Nicox annonce une réunion pré-NDA positive avec la FDA américaine pour...

Nicox annonce une réunion pré-NDA positive avec la FDA américaine pour NCX 470 Communiqué de presseNicox annonce une réunion pré-NDA positive avec la FDA américaine pour NCX 470  Le dépôt de la demande d’autorisation de mise sur le marché (NDA) aux Etats-Unis reste prévu pour l’été 2026Nicox percevra un paiement d’étape de Kowa lors du dépôt de la NDALa soumission de la NDA s’appuie sur les données cliniques de Phase 3 montrant que NCX 470 a réduit la pression intraoculaire jusqu’à 10 mmHg chez les patients atteints de glaucome à angle ouvert ou d’hypertension oculaire 16 février 2026 – pu...

 PRESS RELEASE

Nicox confirme son éligibilité au PEA-PME

Nicox confirme son éligibilité au PEA-PME Communiqué de presseNicox confirme son éligibilité au PEA-PME12 février 2026 – publication à 7H30Sophia Antipolis, FranceNicox SA (Euronext Growth Paris : FR0013018124, ALCOX, éligible PEA-PME), société internationale spécialisée en ophtalmologie, confirme son éligibilité au PEA-PME pour l’année à venir. Pour les besoins de cette confirmation, les critères d'éligibilité des titres de la société Nicox au PEA-PME, prévus par l'article L 221-32-2 du code monétaire et financier, ont été appréciés conformément aux modalités prévues par l'article D 221-11...

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