Press Release
Nicox Raises €10 Million in Private Placement
- Net proceeds from the private placement to extend the cash runway to mid-May 2024
- Warrants to be issued in the private placement could provide an additional €11.6 million proceeds if they were to be fully exercised
November 22, 2022 – release at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced a financing through a private placement via the issuance of 6,849,316 new ordinary shares, each share with an attached warrant to acquire 6,849,316 additional new ordinary shares, at an offering price of €1.46 per share and associated warrant exercisable at a price of €1.70 (unit), with anticipated gross proceeds of €10 million, representing net proceeds of approximately €8.9 million, excluding the potential exercise of the associated warrants.
In parallel with this financing, Nicox exercised its option to extend the period of interest-only payment of its existing Kreos Capital debt by 6 months to January 1, 2024. Capital repayments will therefore recommence from February 1, 2024. This extension was conditional upon NCX 470 meeting the primary objective of non-inferiority to latanoprost in the recently reported Mont Blanc Phase 3 trial.
The Company was previously financed to mid-November 2023. Proceeds from this equity financing, together with the extension of the period of interest-only payment of the Kreos debt, are expected to extend the cash runway to mid-May 2024. This cash runway is based exclusively on the development of NCX 470. The calculation does not include any potential proceeds from the exercise of the warrants included in the private placement (the exercise of which are not under the Company’s control), which could provide an additional €11.6 million in proceeds if they were to be fully exercised.
Cash Position
The Nicox Group had cash and cash equivalents of €25.6 million (excluding the proceeds of this financing) as of September 30, 2022 and outstanding debt of €21.4 million (including €18.6 million in the form of a bond financing agreement with Kreos signed in January 2019, a €2.0 million credit agreement guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic, and financial lease agreements for €0.8 million). The Nicox Group’s cash position after this private placement would amount to approximately €31 million.
All of the figures related to the cash and debt position of the Nicox Group as of September 30, 2022 are unaudited.
Nicox has carried out a specific review of its liquidity risk and considers that the Company has sufficient net working capital to meet its cash requirements for the next twelve months and is financed until mid-May 2024, based exclusively on the development of NCX 470.
Upcoming milestones on key development programs
- Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: Topline results currently expected in 2025
- Initiation of two new Phase 3b clinical trials investigating the dual mechanism of action (nitric oxide and prostaglandin analog) in IOP lowering and potential retinal benefits of NCX 470: planned in H1 2023
Portfolio and Pipeline
The pipeline of product candidates and products is available on the Company’s website.
NCX 470 is a novel nitric oxide (NO)-donating bimatoprost eye drop, currently in Phase 3 clinical development for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. The first Phase 3 clinical trial, Mont Blanc, has been completed and results were announced on October 31, 2022. A second Phase 3 clinical trial, Denali, is ongoing, with results currently expected in 2025. This is beyond the estimated cash runway (May 2024), and therefore additional financing would be required to complete that trial. Two new Phase 3b clinical trials evaluating the dual mechanism of action (NO and prostaglandin analog) in IOP lowering and the potential retinal benefits of NCX 470 are planned to start in H1 2023. These new clinical trials will evaluate (i) the effect of NCX 470 on Episcleral Venous Pressure (EVP) and outflow through the trabecular meshwork and (ii) ocular perfusion via Optical Coherence Tomography (OCT) angiography on retinal vessels. Together, these trials are designed to validate NCX 470’s dual mechanism of action in humans and potentially demonstrate some of the beneficial effects on the retina that have been observed in nonclinical models. The Company is actively looking for commercial partners in the U.S. and Japan, to maximize the potential future value of NCX 470. In the Chinese market, NCX 470 is exclusively licensed to Ocumension Therapeutics, who are also jointly and equally funding the Denali clinical trial.
NCX 1728 is an NO-donating phosphodiesterase-5 (PDE-5) inhibitor under evaluation for development in certain retinal conditions. It is currently in nonclinical development. Progression in the nonclinical evaluation of NCX 1728 has established it as a potential candidate for indications in the area of retinal conditions, and therefore the Company will not conduct further evaluation of NCX 1728 for the lowering of IOP.
NCX 4251 is a novel, patented, ophthalmic suspension of fluticasone propionate nanocrystals, in development for dry eye disease. NCX 4251 has completed a Phase 2 clinical trial, Mississippi, in blepharitis (announced September 23, 2021), which did not meet the primary or secondary efficacy endpoints. Post hoc results, announced November 30, 2021, showed a statistically and clinically significant reduction in dry eye disease symptoms versus placebo in patients who scored more highly for a key sign of dry eye disease (fluorescein staining) and following a subsequent meeting with the U.S. Food and Drug Administration (FDA), the future development of NCX 4251 is focused on dry eye disease. No development activities are currently ongoing outside China pending the Company entering into a partnership for the development and commercialization of NCX 4251 in the U.S. Nicox is seeking a partner for the development and commercialization of NCX 4251 outside of the Chinese market where it is exclusively licensed to Ocumension.
VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, indicated for the reduction of IOP in patients with open angle glaucoma or ocular hypertension, is exclusively licensed worldwide to Bausch + Lomb, a leading global eye health company. VYZULTA is commercialized in multiple countries including the U.S., with other approvals and launches ongoing.
ZERVIATE® (cetirizine ophthalmic solution), 0.24%, indicated for the treatment of ocular itching associated with allergic conjunctivitis, has been exclusively licensed in the U.S. to Eyevance Pharmaceuticals and is commercialized there since March 2020. ZERVIATE has also been exclusively licensed to Ocumension for development and commercialization in the Chinese and the majority of the South East Asian markets. An additional Phase 3 clinical trial has been completed in China and a New Drug Application is in preparation. ZERVIATE is also the subject of exclusive licensing agreements with Samil Pharmaceutical in South Korea and Vietnam, with ITROM Pharmaceutical Group in the Gulf Arab States and with Laboratorios Grin in Mexico.
The clinical trials investigating the dual mechanism of action and potential retinal benefits of NCX 470 are expected to be fully financed with the proceeds of this equity financing. Results from the Denali trial for NCX 470 are currently expected in 2025, outside of the estimated cash runway, and therefore additional financing would be required to complete that trial. The planned costs of nonclinical activities associated with NCX 1728 are not significant. The costs of development and potential commercialization of Nicox’s product candidate and products NCX 4251, VYZULTA® and ZERVIATE® are, or would be, the responsibility of Nicox’s partners. The net book value of NCX 4251 was decreased to zero (reduction of €15.1 million in 2021 and €11.0 million in H1 2022) in the U.S. due to the additional costs and timings associated with the change in indication, and the subsequent decision to out-license the product. The net book value of ZERVIATE (€26.0 million) corresponds mainly to the value of the asset allocated to the Chinese territory where rights are granted to Ocumension. This follows an impairment (€12.7 million) to the value in the U.S. taking into consideration changes in the U.S. market for topical anti-allergics.
Principal terms of the equity financing
The share capital increase without preferential rights, by issuance of 6,849,316 new ordinary shareswith attached warrants to acquire 6,849,316 additional new ordinary shares (the warrants, and together with the new shares, the units) was reserved for subscription by (i) one or more French or foreign companies or mutual funds investing in the pharmaceutical/biotechnology sector (une ou plusieurs sociétés ou fonds gestionnaires d’épargne collective de droit français ou de droit étranger investissant dans le secteur pharmaceutique/biotechnologique), (ii) natural persons who regularly invest in the pharmaceutical/biotechnology sector (des personnes physiques investissant à titre habituel dans le secteur pharmaceutique/biotechnologique) or (iii) one or more credit institutions or any authorized investment services provider undertaking to acquire them for resale to the persons mentioned in (i) and (ii) above (un ou plusieurs établissements de crédit ou tout prestataire de services d’investissement habilité s’engageant à les acquérir pour les revendre aux personnes visées au (i) et (ii) ci-dessus), pursuant to the 8th…
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