- 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 SA is an international ophthalmology company developing
innovative solutions to help maintain vision and improve ocular
health. Nicox’s lead program in clinical development is NCX
470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost
eye drop, for lowering intraocular pressure in patients with
open-angle glaucoma or ocular hypertension. Nicox also has a
preclinical research program on NCX 1728, a nitric oxide-donating
phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first
product, VYZULTA® in glaucoma, licensed exclusively worldwide to
Bausch + Lomb, is available commercially in the U.S. and over 15
other territories. Nicox generates revenue from ZERVIATE® in
allergic conjunctivitis, licensed in multiple geographies,
including to Harrow, Inc. in the U.S., and Ocumension Therapeutics
in the Chinese and in the majority of Southeast Asian
markets. .
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 |
