Nicox's Shareholder Letter
March 22 2024 - 2:30AM
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
nicox.com/investors/shareholder-meetings/.
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
- EN Final Nicox Shareholder letter_ 20230322
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