Announcement • May 20
Nicox S.A., Annual General Meeting, Jun 24, 2026 Nicox S.A., Annual General Meeting, Jun 24, 2026. Location: rue evariste galois, emerald square batiment c, biot France Announcement • Feb 24
Nicox SA Highlights Positive NCX 470 Phase 3 Data Confirming Therapeutic Profile at the 2026 American Glaucoma Society Annual Meeting Nicox SA 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 Society (AGS) Annual Meeting (February 19 to February 22), one of the key scientific events in vision research. Data presented at AGS show that NCX 470, a novel, fast acting molecule, demonstrated best-in-class intraocular pressure (IOP) lowering efficacy of up to 10mmHg from baseline which has met the efficacy requirements for a New Drug Application in the U.S. and China. Announcement • Jan 06
Nicox S.A. announced that it expects to receive €4.000031 million in funding from Vester Finance Nicox S.A announced a private placement to issue unsecured convertible bonds for aggregate proceeds of €3,000,028 and Ordinary bonds for aggregate proceeds of €1,000,003.2, total gross proceeds of €4,000,031.2 on January 5, 2025. The convertible bonds s bear no interest and are unsecured. The bonds are convertible at any time, at a conversion price determined based on the stock market price3 at the time, in accordance with pricing rules and the ceiling set by the shareholders’ meeting. The Ordinary bonds do not bear any interest nor guarantees and have the same term as the convertible bonds. Their subscription price will be made as one payment, at the moment when certain conditions have been met, at the latest at the start of September 2026. At a term of 24 months following the issuance, the bonds will be redeemed at maturity at 100% of their nominal value if they have not been converted at that date. The transaction will include participation from Vester Finance.
On the same day, the company issued the convertible bonds for aggregate proceeds of €3,000,028 in its first tranche. Announcement • Sep 04
Nicox S.A. Provides Portfolio Update Nicox S.A. provided portfolio update. NCX 470, Nicox’s lead product candidate, is licensed globally to two top-tier pharma partners, Kowa and Ocumension Therapeutics. The first two Phase 3 trials, Mont Blanc and Denali, have met the requirements for submission of NDAs in the U.S. and China. U.S. – based on Nicox’s projections, an NDA with the U.S. Food and Drug Administration (FDA) is expected to be submitted in H1 2026. Kowa is responsible for the costs of the NDA submission.China – an NDA is expected to be filed with the Chinese regulatory authorities by its partner, Ocumension, after the U.S. submission. The costs of filing the NDA are the responsibility of Ocumension.Japan – a Phase 3 confirmatory efficacy and a Phase 3 safety trial have been initiated in Japanese patients. Kowa is responsible for managing the trials, at their cost, and expect to be able to file for a marketing authorisation in Japan based on these trials.Europe – the regulatory strategy is being evaluated. NCX 1728, an NO-donating PDE-5 inhibitor, is being evaluated in a pre-clinical research program exploring indications for the treatment of glaucoma, including neuroprotection, and in the treatment of retinal diseases, under an exclusive research and option to license agreement with Glaukos. Glaukos has paid an extension fee to prolong the period of evaluation of NCX 1728 for the treatment of glaucoma. Evaluation for retinal conditions is also continuing, and is subject to different option conditions. ZERVIATE (cetirizine ophthalmic solution), 0.24%, is currently commercialized through exclusive licensing agreements in the U.S. by Harrow Inc. and in China by Ocumension Therapeutics for ocular itching associated with allergic conjunctivitis. VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, is exclusively licensed worldwide to Bausch + Lomb. Nicoxsold the royalty revenue from VYZULTA to Soleus Capital in October 2024. NCX 4251: Changes in the U.S. dry eye market suggest that the investment in development may not be justified. NCX 4251 remains available for licensing outside the Chinese market. Announcement • Aug 05
Nicox Sa's Partner Kowa Initiates Ncx 470 Phase 3 Clinical Trial in Japan Nicox SA announced that its exclusive Japanese partner, Kowa, has initiated a Phase 3 safety clinical trial of NCX 470 (also known as K-911) in Japan for the treatment of ocular hypertension, trigger a EUR2 million milestone payment to Nicox. Only one Phase 3 confirmatory clinical trial in Japanese patients, which will start shortly, plus this safety trial, is required for submission for marketing approval of NCX 470 in Japan. Kowa is responsible for financing and managing the trials under the February 2024 license agreement with Nicox. Announcement • Jun 30
Nicox SA Announces Last Patient Completes the NCX 470 Denali Phase 3 Clinical Trial Nicox SA announced that the last patient has completed the Denali Phase 3 trial, evaluating the efficacy and safety of NCX 470, its lead compound, in patients with open-angle glaucoma or ocular hypertension. With this milestone reached, all patients have now completed their treatment and follow-up visits. A total of 696 patients were enrolled in the trial and topline results are expected mid-August to mid-September 2025. NCX 470, Nicox's lead clinical product candidate, is a novel 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 pulmonary hypertension. The Denali trial is evaluating the IOP lowering efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprostophthalmic solution 0.005% in patients with open-angleglaucoma or ocular diabetes. It is a multi-country (U.S. and China) clinical trial financed equally by Nicox and Ocumension, Nicox's exclusive licensee for China, Korea and Southeast Asia. The Denali trial, together with the already completed Mont Blanc trial, was designed to fulfil the clinical regulatory requirements to support New Drug Application (NDA) submissions of NCX 470 in the U.S. and China. All remaining NDA-enabling pharmacokinetic and non-clinical studies necessary to support the U.S. NDA filing are on track. Subject to securing a U.S. partner, or obtaining the necessary funding, the Company estimates that a NDA for this country NCX 470 could potentially be submitted in first quarter of 2026. Denali Phase 3 clinical trial evaluating NCX 470 in patients with open- angle glaucoma or ophthalmic hypertension: Topline results are expected mid- August to mid-September 2025; NCX 470 Phase 3 clinical efficacy and long-term safety trials in Japan: Initiation expected in second quarter of 2025; NCX 470 NDA filing in the United States: expected in first quarter of 2026, subject to securing a U.S., or obtaining the necessary funding. Announcement • May 22
Nicox S.A., Annual General Meeting, Jun 27, 2025 Nicox S.A., Annual General Meeting, Jun 27, 2025. Location: sundesk sophia antipolis, rue evariste galois, emerald square batiment c, biot France Announcement • May 14
Nicox SA Announces Results of the Exploratory Whistler Phase 3B Glaucoma Trial Nicox SA announced the results of the Whistler Phase 3b exploratory clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in intraocular pressure (IOP) lowering in healthy volunteers and ocular hypertension. The company believe that the outcomes in favor of NCX 470 in several trabecular meshwork aqueous humor dynamics parameters are due to nitric oxide. These positive exploratory results suggest that further investigation may be warranted into the dual mechanism effect of NCX 470 on intraocular pressure. The therapeutic characteristics of NCX 470 demonstrated in the Phase 3 program so far shows that the company have an approvable and differentiated asset with a promising clinical profile. The company believe this change is due to the effect of nitric oxide on the trabecular meshwork1. IOP lowering and uveoscleral outflow were statistically significant at all timepoints measured, whilst episcleral venous pressure did not show a notable trend. These findings support the dual mechanism of action for IOP lowering of NCX 470 through both the conventional (nitric oxide-stimulated) and the uveoscleral (prostaglandin-stimulated) pathways. The safety profile observed was consistent with that of the first Phase 3 trial, Mont Blanc. The Whistler trial was an exploratory trial and is not a requirement for the submission of New Drug Applications for NCX 470 and therefore does not impact the development timeline. The patient population in the Whistler trial was primarily normotensive healthy volunteers with mean baseline IOPs of 16.6 mmHg and 16.9 mmHg for NCX 470 and placebo treated patients, respectively. This is not the same patient profile as in the Phase 3 glaucoma program. Safety and efficacy have already been demonstrated in the first Phase 3 clinical trial, Mont Blanc. Announcement • Mar 19
Nicox SA Announces Last Patient Completes Final Visit in NCX 470 Phase 3b Whistler Glaucoma Trial Nicox SA announced that the last patient completed their final visit in the Whistler Phase 3b clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in intraocular pressure (IOP) lowering. The Whistler Phase 3b trial enrolled 18 healthy volunteers with ocular hypertension in a double-masked, placebo-controlled study investigating the action of NCX 470 on aqueous humor parameters including trabecular meshwork outflow and episcleral venous pressure. Each subject participated in the trial for approximately 8 days. NCX 470, Nicox's lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the two Phase 3 clinical trials, have been extensively published and are available on website. The second Phase 3 clinical trial, Denali, is currently ongoing. The last American patient in Denali has completed their final visit, with Chinese patients completing theirs, and the results are expected in third quarter 2025. Mont Blanc and Denali have been designed to fulfill the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China, where NCX 470 is exclusively licensed to Ocumension Therapeutics. NCX 470 is also licensed exclusively to Kowa for Japan. New Risk • Oct 20
New major risk - Financial data availability The company's latest financial reports are more than a year old. Last reported fiscal period ended June 2023. This is considered a major risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. In the worst case scenario, it may be facing other major going concern issues jeopardizing its viability as a listed company. Currently, the following risks have been identified for the company: Major Risks Latest financial reports are more than 1 year old (reported June 2023 fiscal period end). Share price has been highly volatile over the past 3 months (38% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€15m net loss in 2 years). Shareholders have been diluted in the past year (28% increase in shares outstanding). Revenue is less than US$5m (€3.6m revenue, or US$3.9m). Market cap is less than US$100m (€17.1m market cap, or US$18.6m). Breakeven Date Change • Oct 15
No longer forecast to breakeven The analyst covering Nicox no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of €65.7m in 2025. New forecast suggests the company will make a loss of €16.0m in 2025. Announcement • Jul 25
Nicox SA Announces Recruitment of Last Patient in U.S. in Denali Phase 3 Trial of NCX 470 Nicox SA announced the recruitment and randomization of the last patient in the U.S. in its Denali Phase 3 trial of NCX 470. The Denali trial is evaluating NCX 470 safety and efficacy in patients with open-angle glaucoma or ocular hypertension and topline results continue to be expected in second half of 2025, based on this completion of recruitment of patients in the U.S. and continuing good progress of the trial in China, where recruitment of patients is still ongoing. More than 95% of the total target number of patients have been randomized in this trial so far. The Denali trial is evaluating the intraocular pressure (IOP) lowering efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005% in patients with open-angle glaucoma or ocular hypertension. It is a multi-country (U.S. and China) clinical trial financed equally by Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea and Southeast Asia. The Denali trial, together with the Mont Blanc trial, was designed to fulfill the regulatory requirements to support New Drug Application (NDA) submissions of NCX 470 in the U.S. and China. The U.S. NDA for NCX 470 is expected to be submitted in first half 2026. Topline results from the first Phase 3 trial, Mont Blanc, showed the IOP-lowering effect from baseline was 8.0 to 9.7 mmHg for NCX 470 vs. 7.1 to 9.4 mmHg for latanoprost. Statistical non-inferiority was met vs. latanoprost in the primary efficacy analysis and 4 out of 6 timepoints additionally demonstrated superiority; the trial therefore met the efficacy requirements for approval in the U.S. NCX 470 was well tolerated and discontinuation rates were low. The results of the Mont Blanc trial have been published in the prestigious American Journal of Ophthalmology, and numerous post hoc analyses have been presented. Breakeven Date Change • Jul 21
No longer forecast to breakeven The analyst covering Nicox no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of €65.7m in 2025. New forecast suggests the company will make a loss of €11.3m in 2025. Announcement • Jul 16
Nicox S.A. Announces Board Changes Nicox S.A. announced the appointment of the highly experienced healthcare executive, non-executive Director/Chair and advisor Damian Marron as Chair of the Board of Directors. Marc Le Bozec, an experienced life sciences entrepreneur, is also appointed as a new Director of Nicox. Both Damian Marron and Marc Le Bozec are independent Directors in accordance with the criteria set out by the recommendation 3 of the Middlenext Governance Code. Jean-François Labbe is retiring as Chair and member of the Board, at the completion of his term. Les Kaplan has also decided to step down from the Board. Both Jean-Francois Labbé and Les Kaplan have contributed many years of service as Directors of Nicox. Damian Marron is a seasoned executive, 4-time CEO, Chair, non-executive Board Member and company advisor with a proven track record in value creation through public funding, venture capital, portfolio planning, mergers and acquisitions, and license agreements, as well as R&D collaborations. He has extensive experience in both executive and independent administrator roles, with a specialization in immuno-oncology, cellular therapy, and orphan diseases. He is currently Chair of the Board of Directors for Circio Holding ASA, Imophoron Ltd, and Indegra Therapeutics Ltd. Marc Le Bozec is a life sciences entrepreneur with a strong background in finance, organization and strategic consulting. As CFO of Cellectis, he led its IPO in Paris in 2007 and raised €120 million from 2006 to 2013. He then redirected the company Cytoo towards human muscle research, leading to FDA validation and becoming a key shareholder of the company. After nine years as a professional investor, notably as fund manager at Financière Arbevel, he resumed consulting and also founded Neurodyx in January 2024 to advance neuro-inflammation research. Nicox's Board of Directors is composed as follows: Damian Marron, Chair of the Board and Independent Director, Gavin Spencer, Chief Executive Officer and Director, Michele Garufi, Co-Founder and Director, Marc le Bozec, Independent Director. New Risk • Jun 23
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 27% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Currently unprofitable and not forecast to become profitable next year (€15m net loss next year). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). Revenue is less than US$5m (€3.6m revenue, or US$3.8m). Market cap is less than US$100m (€13.0m market cap, or US$13.9m). Announcement • May 26
Nicox S.A., Annual General Meeting, Jun 28, 2024 Nicox S.A., Annual General Meeting, Jun 28, 2024. Location: buroclub drakkar 2 batiment d, 2405 route des dolines, valbonne sophia antipolis France Board Change • May 21
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 4 experienced directors. 3 highly experienced directors. Co-Founder & Director Michele Garufi is the most experienced director on the board, commencing their role in 1996. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. New Risk • May 07
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Currently unprofitable and not forecast to become profitable next year (€15m net loss next year). Share price has been volatile over the past 3 months (8.0% average weekly change). Revenue is less than US$5m (€3.6m revenue, or US$3.8m). Market cap is less than US$100m (€18.8m market cap, or US$20.2m). Announcement • Jan 31
Nicox SA Receives Confirmation of 5-Year Patent Term Extension of U.S. Patent for Latanoprostene Bunod, Commercialized as VYZULTA Nicox SA announced that the United States Patent and Trademark Office (USPTO) has determined that U.S. Patent No. 7,629,345, which covers latanoprostene bunod, commercialized by Bausch + Lomb under the trademark VYZULTA, is eligible for patent term extension of five years. Nicox has also applied for patent term extension of two other patents covering latanoprostene bunod, U.S. patent Nos. 7,273,946 and 8,058,467. Nicox, in collaboration with Bausch + Lomb, must now elect which patent will be the subject of the patent term extension, and, depending on the choice of the patent, this may lead to an extension to either 2029 or 2030. Announcement • Dec 14
Nicox's Announces Publication of New Nonclinical Data Demonstrating More Effective Intraocular Pressure Lowering of NCX 470 Compared to Lumigan Nicox SA announced that new nonclinical data on NCX 470 (0.1%) demonstrating greater intraocular pressure (IOP) lowering than Lumigan® (bimatoprost ophthalmic solution, 0.01%) upon both single and repeated (5-day) dosing in an in vivo nonclinical model has been published in the peer-reviewed Journal of Ocular Pharmacology and Therapeutics. The publication also includes outflow data on NCX 470 in a different in vivo non clinical model and on NCX 470 compared to equimolar bimatoprost in in vitro human trabecular meshwork/Schlemm’s canal constructs suggesting that NCX 470-mediated increase in outflow facility and uveoscleral outflow accounts for the robust IOP reduction exerted by this compound. NCX 470, a novel nitric oxide (NO)-donating bimatoprost eyedrop, is in Phase 3 clinical development for the lowering of IOP in patients with open angle glaucoma or ocular hypertension. NCX 470 is designed to release both bimatoprost and NO into the eye to lower IOP by two pathways. Lumigan, marketed by Allergan Inc., is the leading branded product by sales in the class of prostaglandin analogs, the most widely used class of drugs for IOP-lowering in patients with open-angle glaucoma or ocular hypertension. IOP lowering was measured in ocular normotensive beagle dogs following either single or repeat once-daily morning dosing over 5 consecutive days, in an open-label crossover design, of either NCX 470 (0.1%), Lumigan® (bimatoprost ophthalmic solution, 0.01%) or vehicle. After single-dosing, NCX 470 demonstrated greater IOP reduction than Lumigan at most timepoints tested up to 24 hours post-dosing, with the greatest difference seen at 5 hours. In the repeat dosing study, the effects of both NCX 470 and Lumigan were generally stable throughout the period of the study, with NCX 470 showing consistently greater IOP reduction than Lumigan® at all timepoints tested. Aqueous humor dynamics were studied in ocular normotensive non-human primates treated in a crossover design with either NCX 470 or vehicle over 4 days. Measurements were taken on the fourth day and demonstrated that NCX 470 increased both outflow facility and uveoscleral outflow compared to vehicle. Aqueous humor outflow was also investigated in human trabecular meshwork/Schlemm’s canal constructs treated with equimolar NCX 470 or bimatoprost, or vehicle. Outflow facility was increased by both NCX 470 and bimatoprost compared to vehicle, with NCX 470 having a greater effect than bimatoprost. New Risk • Nov 15
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 5.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€21m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings are forecast to decline by an average of 5.7% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable next year (€17m net loss next year). Shareholders have been diluted in the past year (16% increase in shares outstanding). Revenue is less than US$5m (€3.6m revenue, or US$3.9m). Market cap is less than US$100m (€21.0m market cap, or US$22.8m). Reported Earnings • Oct 26
First half 2023 earnings released: €0.13 loss per share (vs €0.39 loss in 1H 2022) First half 2023 results: €0.13 loss per share (improved from €0.39 loss in 1H 2022). Net loss: €6.61m (loss narrowed 61% from 1H 2022). Revenue is forecast to grow 34% p.a. on average during the next 2 years, compared to a 16% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 4% per year but the company’s share price has fallen by 56% per year, which means it is significantly lagging earnings. New Risk • Oct 21
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 15% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.2% average weekly change). Earnings are forecast to decline by an average of 15% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable next year (€23m net loss next year). Shareholders have been diluted in the past year (16% increase in shares outstanding). Revenue is less than US$5m (€3.6m revenue, or US$3.8m). Market cap is less than US$100m (€18.0m market cap, or US$19.1m). Announcement • Jul 22
Nicox S.A. to Report Q2, 2023 Results on Jul 19, 2023 Nicox S.A. announced that they will report Q2, 2023 results on Jul 19, 2023 Reported Earnings • Mar 25
Full year 2022 earnings released Full year 2022 results: Net loss: €27.8m (loss narrowed 37% from FY 2021). Announcement • Feb 14
Nicox S.A., Annual General Meeting, Feb 28, 2023 Nicox S.A., Annual General Meeting, Feb 28, 2023, at 14:00 Central European Standard Time. Location: BuroClub - Drakkar 2 - Bâtiment D - 2405 route des Dolines - 06560 Valbonne Sophia Antipolis France Announcement • Jan 09
Nicox S.A., Annual General Meeting, Feb 14, 2023 Nicox S.A., Annual General Meeting, Feb 14, 2023, at 14:00 Central European Standard Time. Location: BuroClub - Drakkar 2 - Bâtiment D - 2405 route des Dolines - 06560 Valbonne France Agenda: To propose Intention to transfer listing from the Euronext Paris regulated market to Euronext Growth Paris. Reported Earnings • Sep 17
First half 2022 earnings released: EPS: €0 (vs €0.32 loss in 1H 2021) First half 2022 results: EPS: €0. Net loss: €17.0m (loss widened 45% from 1H 2021). Revenue is forecast to grow 27% p.a. on average during the next 2 years, compared to a 19% growth forecast for the Biotechs industry in Germany. Announcement • Jul 29
Nicox Appoints Jean-Francois Labbé as Chairman of the Board of Directors Nicox SA announced that Jean-Francois Labbé, a Board member of Nicox SA, has been appointed as Chairman of the Nicox Board of Directors, effective July 28, 2022. Michele Garufi, who has filled the role ad interim since June 1, 2022, will remain as a Board member. Jean-François Labbé has served as a member of Nicox’ Board of Directors since June 2010 and has been the Chairman of the Audit Committee of Nicox since July 2013. M. Labbé is the Founder and Chief Executive Officer of SpePharm Holding BV, a pan-European specialty pharma company. Announcement • Jul 07
Nicox Announces Publication of NCX 470 Results Demonstrating Improvements to Ocular Hemodynamics and Retinal Cell Physiology Nicox SA announced that the results from studies on the beneficial effects of NCX 470 in a nonclinical model of endothelin-1 (ET-1)-induced ischemia/reperfusion damage of the optic nerve head and retina have been published online in the peer-reviewed Journal of Ocular Pharmacology and Therapeutics. The publication “NCX 470 restores ocular hemodynamics and retinal cell physiology after ET-1-induced ischemia/reperfusion injury of optic nerve and retina in rabbits” by Bastiaet al. is available by clicking here [1]. NCX 470, Nicox’s lead clinical product candidate, is a novel, potential best-in-class, nitric oxide (NO)-donating prostaglandin eye drop currently in Phase 3 clinical development for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. NCX 470 is currently being evaluated in two multi-regional Phase 3 clinical trials, Mont Blanc and Denali. The statistical objective of these two Phase 3 trials is to demonstrate non-inferiority, and if successful, statistical superiority in IOP lowering of once-daily dosed NCX 470 ophthalmic solution 0.1% over latanoprost ophthalmic solution 0.005% (first marketed as Xalatan), the most prescribed prostaglandin analog in the U.S. for patients with open-angle glaucoma or ocular hypertension. About Glaucoma and NCX 470 Glaucoma is a disease of the optic nerve which, if left untreated, can lead to irreversible vision loss. Glaucoma is frequently linked to elevated intraocular pressure (90% of patients) and is often due to blockage in the drainage system located in the front of the eye. Currently, reducing intraocular pressure remains the only way to slow the progression of the disease. About 3 million people in the United States between 40 and 80 years of age are affected by the most common form of glaucoma, open-angle glaucoma. NCX 470 is a novel, potential best-in-class, nitric oxide (NO)-donating prostaglandin analog eye drop designed to release bimatoprost and NO following instillation into the eye. Bimatoprost, marketed under the brand name LUMIGAN® by AbbVie Inc., is one of the leading branded products in the class of prostaglandin analogs. Prostaglandin analogs are the most widely used class of drugs for IOP-lowering in patients with open-angle glaucoma or ocular hypertension. NCX 470 is in development to reduce IOP in patients with open-angle glaucoma or ocular hypertension. Nitric oxide brings additional IOP-lowering efficacy by enhancing aqueous humor drainage from the eye via a different mechanism of action than that engaged by prostaglandin analogs. Announcement • Jun 14
Nicox S.A., Annual General Meeting, Jun 28, 2022 Nicox S.A., Annual General Meeting, Jun 28, 2022, at 14:00 Central European Standard Time. Location: offices of BuroClub, Drakkar 2, Bâtiment D, 2405 route des Dolines Valbonne France Announcement • Jun 03
Nicox S.A. Accelerates Topline Results from NCX 470 Mont Blanc Phase 3 Glaucoma Trial to November 2022 Nicox SA announced that it has closed screening for additional patients in its Phase 3 Mont Blanc clinical trial of NCX 470 0.1% in patients with open-angle glaucoma or ocular hypertension. Therefore, the Company now expects to advance the announcement of the Mont Blanc topline results to November 2022, as opposed to First Quarter 2023. NCX 470 0.065% has already demonstrated a statistically significant greater reduction of intraocular pressure compared to latanoprost 0.005% in a Phase 2 trial and is being evaluated in Phase 3 at a higher concentration than was tested in Phase 2. In the earlier Dolomites Phase 2 clinical trial, NCX 470 0.065% demonstrated statistical superior lowering of intraocular pressure of up to 1.4 mmHg compared to latanoprost 0.005% at Day 28. The results of the Dolomites trial were recently published in the Journal of Glaucoma. Mont Blanc is a Phase 3 clinical trial in patients with elevated intraocular pressure due to open-angle glaucoma or ocular hypertension. The Mont Blanc Phase 3 trial had an initial adaptive design period during which NCX 470 0.065% was evaluated together with the higher concentration of NCX 470 0.1%. Following the adaptive design period, the NCX 470 0.1% concentration was chosen to continue in the Mont Blanc Phase 3 trial, and was used to initiate the second Phase 3 clinical trial, Denali. Mont Blanc continued after the adaptive design period as a multi-regional, double-masked, 3-month, parallel group trial evaluating the efficacy and safety of NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution, 0.005%. Latanoprost is the most widely prescribed first-line therapy for open-angle glaucoma or ocular hypertension. The primary efficacy evaluation in Mont Blanc is based on time-matched IOP at 8 AM and 4 PM at Week 2, Week 6 and Month 3. Nicox retains 100% of the rights to NCX 470, notably in U.S., Europe and Japan, other than those licensed to its partner Ocumension Therapeutics in China and elsewhere in the Far East. Nicox intends to continue developing NCX 470 itself in the U.S., and to partner in other key territories, particularly in Japan, as a key market opportunity. The Denali topline results are expected after 2023 and the Company will announce a new date for availability of the results when the company have a more firm estimate of the overall timelines of the trial. Announcement • May 16
Nicox S.A. Announces Executive Changes NicoxSA announced that its Board of Directors appointed Andreas Segerros as Chief Executive Officer of Nicox S. A on May 13th, 2022, effective from June 1st, 2022, following the Board’s decision to end the mandate of Michele Garufi, who has been Chairman, Chief Executive Officer and Co-Founder of the Company since its creation in 1996. Michele Garufi will remain as Board member of Nicox SA. Andreas Segerros has spent most of his career in global pharma, with executive positions (R&D, Marketing and Business Development) in the U.S., Europe and Japan, at Pharmacia, Pharmacia & Upjohn and Ferring, with the focus on specialty Pharma, ophthalmology in particular. As Global Head of Ophthalmology at Pharmacia, Andreas launched XALATAN® (latanoprost), making it the industry’s first billion-dollar ophthalmic drug. His venture capital experience comes from being Partner at the Scandinavian group Sunstone Capital, and also co-founded Eir Ventures. Andreas has made numerous investments in successful companies in Europe and the U.S. Announcement • May 04
Nicox S.A., Annual General Meeting, Jun 14, 2022 Nicox S.A., Annual General Meeting, Jun 14, 2022, at 14:00 Central European Standard Time. Location: BuroClub - Drakkar 2 - Bâtiment D - 2405 route des Dolines - 06560 Valbonne France Reported Earnings • May 01
Full year 2021 earnings released: €1.17 loss per share (vs €0.54 loss in FY 2020) Full year 2021 results: €1.17 loss per share (down from €0.54 loss in FY 2020). Net loss: €43.8m (loss widened 142% from FY 2020). Over the next year, revenue is forecast to grow 38%, compared to a 44% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 16% per year but the company’s share price has fallen by 32% per year, which means it is performing significantly worse than earnings. Announcement • Apr 11
Nicox’s NCX 470 Dolomites Phase 2 Results Published in Journal of Glaucoma Nicox SA announced that the results from its Dolomites Phase 2 clinical trial of NCX 470 in patients with open-angle glaucoma or ocular hypertension have been published online by the Journal of Glaucoma, the official journal of the World Glaucoma Association. The publication “A Randomized, Controlled Comparison of NCX 470 (0.021%, 0.042% and 0.065%) and Latanoprost 0.005% in Patients with Open-Angle Glaucoma or Ocular Hypertension: The Dolomites Study”» is available by clicking here. NCX 470 is currently in two Phase 3 clinical trials. Dolomites was a dose-response Phase 2 clinical trial comparing three concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) to latanoprost ophthalmic solution, 0.005% in 433 patients with open-angle glaucoma or ocular hypertension. Aligned with previously reported topline results on Dolomites, NCX 470 0.065% achieved statistical superiority compared to latanoprost 0.005% at all time-matched points measured on day 28, with a peak improvement in intraocular pressure (IOP) lowering of 1.4 mmHg greater than latanoprost. All tested concentrations of NCX 470 were statistically non-inferior to latanoprost and the dose response of NCX 470 showed improved IOP lowering with each incremental concentration. NCX 470 was safe and well-tolerated with no drug-related serious adverse events and no evidence of treatment-related systemic side effects. Announcement • Feb 24
Nicox Announces VYZULTA Now Commercialized in 7 Territories and Approved in Further 9 Countries Nicox SA provides an update on the approvals and launches of VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, exclusively licensed worldwide by Nicox to Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. As of December 31, 2021, VYZULTA was commercialized in 7 territories: United States (2017), Canada (2019), Argentina (2020), Mexico (2020), Hong Kong (2020), Taiwan (2021) and Ukraine (2021). VYZULTA is also approved in 9 other countries, namely Brazil, Colombia, Jordan, Qatar, Singapore, South Korea, Thailand, Turkey and United Arab Emirates. VYZULTA is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension in the United States. Bausch + Lomb will continue seeking approvals in territories where the clinical data package, part of the U.S. New Drug Application, can be used for approval by the regulatory authorities. Latanoprostene bunod, the active pharmaceutical ingredient in VYZULTA, was invented and patented by Nicox and was licensed to Bausch + Lomb in 2010. Under the terms of the exclusive global license agreement with Bausch + Lomb, Nicox receives increasing tiered royalties of 6% to 12% on net global sales of VYZULTA and is entitled to receive a $20 million milestone payment1 upon VYZULTA net sales reaching $100 million. Nicox maintains the patents for latanoprostene bunod, and the U. S. Patent and Trademark Office recently determined that three U.S. composition of matter patents covering latanoprostene bunod are eligible for patent term extension, potentially through to 2030. Announcement • Feb 22
Nicox S.A. Announces Chinese National Intellectual Property Administration Grant A Formulation Patent for NCX 470 Nicox SA announced that the Chinese National Intellectual Property Administration (CNIPA) has granted the company a formulation patent for NCX 470, its lead product candidate in development for patients with open-angle glaucoma or ocular hypertension, extending coverage in China to 2039. With the equivalent U.S. and European patents already granted, the formulation is now covered in most major global territories. NCX 470 is also covered by granted composition of matter patents. NCX 470, Nicox’s lead product candidate, is a novel nitric oxide (NO)-donating prostaglandin analog designed to release bimatoprost and NO into the eye. NCX 470 is currently being evaluated against latanoprost, the leading prostaglandin analog by prescription volume in the U.S., in the ongoing Mont Blanc and Denali Phase 3 clinical trials, with results expected in First Quarter 2023 and by the end of 2023, respectively. Nicox has licensed exclusive rights to Ocumension for NCX 470 in China, Korea and Southeast Asia. Ocumension has paid €18 million to Nicox for these rights, and is also funding 50% of the total cost for the Denali Phase 3 clinical trial. Nicox stands to receive tiered royalties of between 6% and 12% on sales of NCX 470 by Ocumension. Ocumension is a Chinese ophthalmology company listed on the Hong Kong stock exchange since July 2020 (HKEX: OCUMENSION-B (1477)). Announcement • Feb 08
Nicox’s Positive FDA Meeting Shows Clear Path for NCX 4251 in Dry Eye Nicox S.A. announced that it will be focusing the future development of NCX 4251 on dry eye disease. This decision follows the encouraging post hoc results from the Mississippi Phase 2b clinical trial and a subsequent positive meeting with the U.S. Food and Drug Administration (FDA). Further pharmaceutical development activities will need to be completed to support the next steps in the clinical development of NCX 4251. The clinical trials are not currently financed, per the recently announced cash runway of Fourth Quarter 2023. Announcement • Dec 16
Nicox Announces First Patient in China screened in the ongoing NCX 470 Denali Phase 3 Trial in Glaucoma Nicox SA announced that the first patient has been screened in China in the ongoing Denali Phase 3 clinical trial, opening the way for New Drug Application (NDA) submissions in both the United States (U.S.) and China for NCX 470, Nicox’s lead clinical product candidate in glaucoma. Denali, which also includes a long-term safety extension, has been recruiting patients in the U.S. since November 2020. Approximately 670 patients are expected to be randomized at approximately 60 clinical sites in the U.S. and China, with approximately 80% of the patients to be recruited in the U.S. and the remaining ~20% of the patients to be recruited in China. This is the first patient to be enrolled in the Chinese part of the trial. Results from Denali are expected by the end of 2023. The Denali Phase 3 trial evaluates the intraocular pressure (IOP) lowering efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005% in patients with open-angle glaucoma or ocular hypertension. Denali is a multiregional (U.S. and China) clinical trial financed equally by Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea and Southeast Asia. The inclusion of Chinese patients in the Denali trial is essential to satisfy the requirements of Chinese regulatory authority, the National Medical Products Administration. The Denali trial was designed to fulfill the regulatory requirements to support NDA submissions of NCX 470 in the U.S. and China. Announcement • Nov 30
Nicox S.A. Announces Positive Post Hoc Results from Its Mississippi Phase 2B Clinical Trial Suggesting That Once-Daily Dosed NCX 4251 Nicox S.A. announced positive post hoc results from its Mississippi Phase 2b clinical trial suggesting that once-daily dosed NCX 4251, fluticasone propionate ophthalmic suspension 0.1%, is effective in reducing dry eye symptoms in a subgroup of patients. The new results show that, for a subgroup of patients scoring more highly for a key sign of dry eye, statistically significant improvements in the number of dry eye symptoms and improvements in one sign (p=0.0524) were seen. The top-line results from the trial, which did not meet the primary or secondary efficacy endpoints, were reported on September 23, 2021. The post hoc analyses identified a subgroup of patients (123 of 224 patients) with baseline scores =2.0 on a scale of 0 (none) to 4 (severe) for inferior cornea fluorescein staining, a key sign of dry eye disease. In this patient group, the analysis demonstrated a statistically significant difference against placebo for change from baseline in eye dryness scores as assessed on a Visual Analog Scale at Day 8 (p=0.0085), Day 11 (p=0.0020) and Day 15 (p“Dry eye disease is reported in some 70-80% of patients with blepharitis. The positive impact of NCX 4251 on the multitude of symptoms associated with dry eye disease in a substantial subgroup of blepharitis patients in the trial provides a compelling rationale to explore a targeted approach to the future development of the program with the FDA. NCX 4251 was found to be safe and well-tolerated over 14 days’ treatment, with no serious adverse events, and all of the adverse events for the NCX 4251 treatment arm were mild. There were no discontinuations in the study due to adverse events. Announcement • Oct 01
Nicox SA Reports New Data on NCX 470 in Nonclinical Model of Retinal Cell Damage Induced by Endothelin-1 Nicox SA reported new data on NCX 470 in a nonclinical model of retinal cell damage induced by endothelin-1 (ET-1). NCX 470, Nicox’s lead clinical candidate, is a nitric oxide-donating prostaglandin analog currently in phase 3 clinical development for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Elevated IOP is the main risk factor in glaucoma, however a variety of IOP-independent risk factors, including ischemia, contribute to damage of the optic nerve head and the retina, ultimately causing vision loss. The exploratory nonclinical studies reported on September 29, 2021 investigated the potential protective effects of NCX 470 on the retina and the optic nerve head. The results suggest that NCX 470 improves ocular perfusion and retinal function in damaged eyes compared to vehicle and therefore may have therapeutic properties over and above lowering of IOP. Nonclinical experiments were performed to determine the effect of NCX 470 on ocular vascular reactivity and retinal function after repeated topical ocular dosing in a well-defined model of ischemia/reperfusion injury to the optic nerve in rabbits induced by ET-1. ET-1 alone was administered twice-weekly for two weeks, followed by concomitant dosing with NCX 470 or vehicle for a further 4 weeks. Twice-weekly dosing with ET-1 increased ophthalmic artery resistivity after two weeks (p<0.05 vs. baseline), and this continued to increase during the next four weeks in the vehicle group to approximately 40% of baseline at week 6. This detrimental effect was significantly reversed in eyes co-administered with NCX 470 0.1% twice daily (p<0.05 vs. vehicle at week 6). In addition, ET-1 dosing resulted in a marked decline in photoreceptor responses, which continued in eyes treated with vehicle. The decline was almost completely reversed by week 6 in eyes treated with NCX 470 (p<0.05 vs. vehicle). Reported Earnings • Sep 28
First half 2021 earnings released The company reported a soft first half result with weaker revenues and control over costs, although losses reduced. First half 2021 results: Revenue: €1.32m (down 45% from 1H 2020). Net loss: €11.7m (loss narrowed 20% from 1H 2020). Announcement • Sep 24
Nicox S.A. Announces Results from the NCX 4251 Phase 2B Mississippi Blepharitis Trial Nicox SA announced the results from its Mississippi Phase 2b clinical trial evaluating once-daily dosed NCX 4251, fluticasone propionate ophthalmic suspension 0.1%, against placebo in patients with acute exacerbations of blepharitis. The primary outcome measure was the proportion of patients achieving complete cure in all three hallmark signs and symptoms of blepharitis, eyelid redness, eyelid debris and eyelid discomfort, at Day 15, with two secondary outcome measures on signs and symptoms of dry eye. The trial did not meet the primary or secondary efficacy endpoints. However, a signal of NCX 4251’s potential efficacy was seen in the trial with NCX 4251 0.1% showing a numerical improvement over placebo in the primary outcome measure of complete cure in eyelid redness, eyelid debris and eyelid discomfort at Day 15. NCX 4251 also showed a statistically significant difference against placebo in the exploratory endpoint of change from baseline in the composite score of the same key signs and symptoms at Day 8 (p=0.03), Day 11 (p=0.01) and Day 15 (p=0.01). Data analysis is continuing in order to decide on the key signs and symptoms of focus for future development. NCX 4251 was found to be safe and well-tolerated over 14 days’ treatment, with no serious adverse events, and all of the adverse events for the NCX 4251 treatment arm were mild. There were no discontinuations in the study due to an adverse event. Board Change • Aug 02
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 5 experienced directors. 1 highly experienced director. Independent Director Labb Labbe is the most experienced director on the board, commencing their role in 2010. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Jul 03
Nicox Announces Last Patient Completed NCX 4251 Mississippi Phase 2B Blepharitis Trial Nicox S.A. announced that the last patient in the NCX 4251 Mississippi Phase 2b blepharitis clinical trial has now completed the two-week treatment phase as well as the required two-week follow up period. Top-line results are expected to be announced in September 2021. NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals. The direct administration of NCX 4251 to the eyelids is designed to target the site of the inflammation whilst minimizing the intraocular exposure to the steroid fluticasone, thereby reducing the risk of adverse effects such as increased intraocular pressure and cataract. Mississippi is a Phase 2b clinical trial of NCX 4251, evaluating once-daily dosed NCX 4251 0.1% versus placebo in patients with acute exacerbations of blepharitis, and has recruited over 200 patients. The primary outcome measure is the proportion of patients achieving at Day 15 complete cure in eyelid redness, eyelid debris and eyelid discomfort, the hallmark signs and symptoms of blepharitis. Announcement • Jul 01
Nicox SA Presented Results from the Dolomites Phase 2 Clinical Trial Showing That NCX 470 Nicox SA presented results from the Dolomites Phase 2 clinical trial showing that NCX 470, a novel nitric oxide (NO)-donating prostaglandin analog (PGA), produced significantly greater intraocular pressure (IOP) lowering effects in glaucoma patients compared with the current standard of care, latanoprost. In Dolomites, a dose-response Phase 2 clinical trial evaluating three concentrations of NCX 470 compared to latanoprost ophthalmic solution, 0.005% in 433 patients with open-angle glaucoma or ocular hypertension, NCX 470 0.065% achieved superiority compared to latanoprost 0.005% at all time points on day 28 with up to 1.4 mmHg superior IOP lowering. All tested concentrations of NCX 470 were non-inferior to latanoprost and the dose response of NCX 470 showed improved IOP lowering with each incremental concentration. NCX 470 was safe and well-tolerated with no drug-related serious adverse events and no evidence of treatment-related systemic side effects. Announcement • Jun 25
Nicox’s Licensee Bausch + Lomb Receives Approval for VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% in the United Arab Emirates Nicox SA announced that its exclusive global licensee Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., has received approval for VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% in the United Arab Emirates. Now approved in 12 countries, VYZULTA is commercialized in the United States (since 2017), Canada (2019), Argentina (2020), Mexico (2020), Hong Kong (2020) and Taiwan (2021). It is also approved in Brazil, Colombia, Qatar, South Korea, Ukraine and the United Arab Emirates. VYZULTA is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension in the United States and other territories that have the same indication. Bausch + Lomb will continue seeking approvals in territories where the clinical data package, part of the U.S. New Drug Application, can be used for approval by the regulatory authorities. Under the terms of the exclusive global license agreement with Bausch + Lomb, Nicox receives increasing tiered royalties of 6% to 12% on net global sales of VYZULTA plus up to $150 million in potential future milestone payments. Announcement • Jun 24
Nicox SA to Present NCX 470 Dolomites Phase 2 Results in Glaucoma Patients at the World Glaucoma E-Congress 2021 Nicox SA announced that results from the Dolomites Phase 2 clinical trial on NCX 470 in patients with open-angle glaucoma or ocular hyper tension will be presented by Dr. David Wirta, Medical Director, Eye Research Foundation (Newport Beach, CA, USA), at the World Glaucoma E-Congress 2021 being held from June 30 – July 3, 2021. Dr. Wirta is one of the clinical investigators in the Dolomites trial. Nicox’s lead clinical development product candidate, NCX 470 is a novel NO-donating prostaglandin analog in late-stage clinical development for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Announcement • Jun 01
Nicox's Completes Pre-Defined Enrollment of NCX 4251 Mississippi Phase 2b Blepharitis Trial Nicox SA announced that more than 200 patients, the pre-defined target, have been randomized in the NCX 4251 Mississippi Phase 2b blepharitis clinical trial. Top-line results are expected to be announced during September 2021. NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals. The direct administration of NCX 4251 to the eyelids is designed to target the site of the inflammation whilst minimizing the intraocular exposure to the steroid fluticasone thereby reducing the risk of adverse effects such as increased intraocular pressure and cataract. Mississippi is a Phase 2b clinical trial of NCX 4251, evaluating once-daily dosed NCX 4251 0.1% versus placebo in patients with acute exacerbations of blepharitis. The primary outcome measure is the proportion of patients achieving complete cure in eyelid redness, eyelid debris and eyelid discomfort, the hallmark signs and symptoms of blepharitis, at Day 15. Should NCX 4251 meet this primary efficacy endpoint for blepharitis, the Mississippi trial could represent the first of two pivotal trials needed to support an NDA in the U.S. for the treatment of acute exacerbations of blepharitis. Announcement • May 04
Nicox’s Licensee Bausch + Lomb Launches VYZULTA® (Latanoprostene Bunod Ophthalmic Solution), 0.024% in Taiwan and Receives Approval in Qatar Nicox SA announced that its exclusive global licensee Bausch + Lomb has launched VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% in Taiwan. Regulatory approval in Taiwan was obtained in March 2020. VYZULTA has also recently received approval in Qatar. In addition to Taiwan, VYZULTA is commercialized in the United States (since 2017), Canada (2019), Argentina (2020), Mexico (2020) and Hong Kong (2020), and is now approved in 5 other territories (Brazil, Colombia, Qatar, South Korea, and Ukraine). VYZULTA is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension in the United States and other territories that have the same indication. Bausch + Lomb will continue seeking approvals in territories where the clinical data package, part of the U.S. New Drug Application, can be used for approval by the regulatory authorities. Under the terms of the exclusive global license agreement with Bausch + Lomb, Nicox receives increasing tiered royalties of 6% to 12% on net global sales of VYZULTA plus up to $150 million in potential future milestone payments. Announcement • Apr 28
U.S. Patent Office Issues Notice of Allowance for Nicox’s Latanoprostene Bunod in Normal Tension Glaucoma Nicox SA announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the U.S. patent covering the use of latanoprostene bunod for the treatment of normal tension glaucoma. Latanoprostene bunod ophthalmic solution, 0.024%, is commercialized as VYZULTA®, for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension in the United States and other territories that have the same indication. Normal tension glaucoma, also known as low tension or normal pressure glaucoma, is a form of glaucoma in which damage occurs to the optic nerve at intraocular pressure (IOP) within the normal range (less than 21 mmHg). Normal tension glaucoma is typically treated by reducing the eye pressure using medications, laser treatments and/or conventional surgery. VYZULTA is commercialized by Nicox’s exclusive global licensee Bausch + Lomb in the U.S. (since 2017), Canada (2019), Argentina (2020), Mexico (2020) and Hong Kong (2020), and is now approved in 5 other territories (Brazil, Colombia, South Korea, Taiwan and Ukraine). Under the terms of the exclusive global license agreement with Bausch + Lomb, Nicox receives increasing tiered royalties of 6% to 12% on net global sales of VYZULTA plus up to $150 million in potential future milestone payments. Announcement • Mar 06
Nicox S.A., Annual General Meeting, Apr 14, 2021 Nicox S.A., Annual General Meeting, Apr 14, 2021, at 14:00 Central European Standard Time. Location: BuroClub - Drakkar 2 - Bâtiment D route des Dolines - 06560 Valbonne France Reported Earnings • Mar 02
Full year 2020 earnings released The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2020 results: Revenue: €12.9m (up 88% from FY 2019). Net loss: €18.1m (loss narrowed 4.4% from FY 2019). Announcement • Mar 02
Nicox S.A. to Report Fiscal Year 2020 Results on Mar 01, 2021 Nicox S.A. announced that they will report fiscal year 2020 results on Mar 01, 2021 Announcement • Feb 23
Nicox Announces the Publication in Leading Scientific Journal of Pre-Clinical Efficacy Results on a New Class of Non-PGA NO-donating IOP-Lowering Compounds Nicox SA announced the publication of pre-clinical intraocular pressure (IOP)-lowering results on a new class of non prostaglandin analog (PGA), nitric oxide (NO)-donating compounds, in the Journal of Ocular Pharmacology and Therapeutics1. Increased IOP is one of the principal risk factors of open-angle glaucoma. The NO-mediated IOP-lowering effect in this new class of compounds is enhanced by concomitant action of phosphodiesterase type-5 (PDE5) inhibition within the same molecule. It have shown with VYZULTA and promising Phase 3 product candidate, NCX 470, that nitric oxide can bring additional efficacy on top of a prostaglandin analog. This new class of compounds enhance the nitric oxide-mediated intraocular pressure lowering effect with the concomitant action of phosphodiesterase type-5 inhibition. The identified product candidates in this class which could potentially be used as monotherapy, or in combination with prostaglandin analogs or other intraocular pressure lowering agents, to add efficacy to existing therapies. The published data on NCX 1741, an analog of Nicox’s development candidate NCX 1728, compared its IOP lowering effect to that of travoprost in a non-human primate model of ocular hypertension. This publication reports that NCX 1741 reduced IOP to a similar extent to travoprost, with faster onset of activity. Travoprost is a prostaglandin analog, a class of molecules which are considered standard of care for IOP lowering in humans. Announcement • Dec 23
Nicox S.A. Licensee Bausch + Lomb Secures Approval of VYZULTA in Colombia Nicox S.A. announced that its partner, Bausch + Lomb, has received approval for latanoprostene bunod ophthalmic solution, 0.024% (marketed as VYZULTA® In the United States) in Colombia, where it will be marketed under the brand name CLIROPTA®. VYZULTA is currently commercialized in the United States, Canada and Argentina and approved in 5 other territories – Colombia, Hong Kong, Mexico, Taiwan and Ukraine - for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Bausch + Lomb will continue seeking approvals in territories where the clinical data package, part of the U.S. New Drug Application, can be used for approval by the regulatory authorities. Under the terms of the exclusive license agreement with Bausch + Lomb, the company receives increasing tiered royalties of 6% to 12% on net global sales of VYZULTA plus up to $150 million in potential future milestones payments. Announcement • Dec 15
Nicox Initiates Phase 2b Trial of NCX 4251, a Potential First-in-Class Treatment for Blepharitis Nicox SA announced the initiation of the Mississippi trial, a Phase 2b clinical trial of NCX 4251, evaluating once-daily dosed NCX 4251 0.1% versus placebo in patients with acute exacerbations of blepharitis. NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals. The direct application of NCX 4251 to the eyelids is designed to target the site of the inflammation whilst minimizing the intraocular exposure to the steroid fluticasone and the risk of developing increased intraocular pressure (IOP) and cataract. The first patient in the Mississippi trial was enrolled in the U.S. on December 14th, 2020. Announcement • Dec 11
Nicox’s Partner Fera Pharmaceuticals to Investigate Naproxcinod as Potential Covid-19 Adjuvant Treatment Nicox SA and Fera Pharmaceuticals announced that Fera will evaluate naproxcinod as a potential adjuvant treatment for patients with COVID-19 infection. Subject to successful completion of the ongoing manufacturing of naproxcinod test material, Fera plans to initiate pre-clinical proof-of-concept studies in models of COVID-19 infection in early 2021. Naproxcinod, a Cyclooxygenase-Inhibiting Nitric Oxide (NO)-Donating (CINOD) naproxen, is a non-steroidal anti-inflammatory product candidate engineered to release NO and naproxen, originally discovered and developed by Nicox. Nicox and Fera entered into an agreement in December 2015 which granted Fera exclusive rights to develop and commercialize naproxcinod for the U.S. market. Nicox and Fera are amending their existing agreement to include COVID-19 as an indication, and Nicox will grant to Fera warrants to acquire 10,000 Nicox shares. Rationale for naproxcinod in COVID-19 treatment: Most outcomes of COVID-19 are associated with high levels of inflammation and dysfunction of the vascular system leading to thrombotic events. Naproxcinod, a Cox-Inhibiting Nitric Oxide Donor (CINOD), would potentially treat multiple aspects of COVID-19 infection including fever, pain, inflammation and platelet aggregation, thus decreasing the risk of thrombus formation. In addition, NO donation might increase vasodilation and restore normal vascular functions. Moreover, NO has specifically been demonstrated to inhibit replication of the COVID-19 virus by two distinct mechanisms. As an oral capsule formulation, naproxcinod could be easily administered to patients at the first signs of infection. Once Fera has received the newly manufactured naproxcinod, they plan to initiate proof-of-concept pre-clinical tests in models of COVID-19 infection. Should the results of these studies prove positive, Fera plans to meet with the U.S. Food and Drug Administration (FDA) to identify the clinical trials that would be required to submit a New Drug Application (NDA) for naproxcinod in the treatment of COVID-19 infection. Under the terms of the naproxcinod agreement with Nicox, Fera is responsible for all clinical development, manufacturing, regulatory and commercialization activities in the U.S. Nicox retains all rights to naproxcinod outside the U.S., subject to the payment of royalties to Fera, if intellectual property developed under the agreement is used outside the U.S. Fera continues to review non-COVID-19 development options for naproxcinod, including addressing the U.S. FDA refusal letter concerning Fera’s application for Orphan Drug Designation (ODD) of naproxcinod in sickle-cell disease. Announcement • Dec 06
Nicox S.A. has completed a Follow-on Equity Offering in the amount of €15.000651 million. Nicox S.A. has completed a Follow-on Equity Offering in the amount of €15.000651 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 3,529,565
Price\Range: €4.25
Transaction Features: Subsequent Direct Listing Is New 90 Day High Low • Nov 14
New 90-day high: €4.10 The company is up 3.0% from its price of €3.99 on 14 August 2020. The German market is up 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Nov 10
Nicox SA Initiates Second Phase 3 Trial of NCX 470 in Glaucoma Nicox SA announced the initiation of the second Phase 3 clinical trial of NCX 470, ‘Denali’, evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The first patients were enrolled in the U.S. on November 9, 2020. NCX 470, Nicox’s lead clinical product candidate, is a novel second-generation nitric oxide (NO)-donating bimatoprost analog. The Denali trial will be financed jointly and in equal parts by Nicox and Ocumension Therapeutics, Nicox’s exclusive licensee for the Chinese, Korean and South East Asian markets. Denali is a 3-month Phase 3 trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, versus the current standard of care, latanoprost ophthalmic solution, 0.005%, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. The trial, which will also include a long-term safety extension, is expected to randomize 650+ patients, at approximately 50 clinical sites in the U.S. and China, with a majority to be recruited in the U.S. The Denali trial was designed to fulfill the regulatory requirements to support NDA submissions of NCX 470 in the U.S. and China. The first Phase 3 trial of NCX 470 is the ongoing Mont Blanc trial which was initiated in the U.S. in June 2020, with top-line results currently expected in Fourth Quarter 2021. The 3-month Mont Blanc trial, also evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, versus latanoprost ophthalmic solution, 0.005%, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension, is expected to randomize approximately 670 patients, at approximately 50 clinical sites in the U.S. and a small number of clinical sites in China. Ocumension recently received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to carry out the Chinese part of Mont Blanc trial. NCX 470 is a novel, potential best-in-class, second generation nitric oxide (NO)-donating bimatoprost analog in development to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Glaucoma is a group of ocular diseases in which the optic nerve is injured, leading to peripheral and, ultimately, central visual field loss and it can eventually lead to blindness if not treated. It is frequently linked to abnormally high IOP (~90% of patients) due to blockage or malfunction of the eye’s aqueous humor drainage system in the front of the eye. In 2019, worldwide sales of treatments targeting glaucoma were over $6.0 billion out of a $21.9 billion worldwide market for ophthalmic drugs. NCX 470 is designed to release both bimatoprost and NO following instillation into the eye. Bimatoprost, marketed under the brand name LUMIGAN® by Allergan Inc., is one of the leading products in the class of prostaglandin analogs, the most widely used class of drugs for IOP-lowering in patients with open-angle glaucoma or ocular hypertension. Is New 90 Day High Low • Oct 16
New 90-day low: €3.45 The company is down 16% from its price of €4.08 on 17 July 2020. The German market is flat over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Oct 13
Nicox Announces Plans for NCX 4251 Phase 2 Trial in Blepharitis Nicox S.A. announced that the upcoming Mississippi Phase 2 trial of its second clinical candidate, NCX 4251 0.1%, will be focused on acute exacerbations of blepharitis. If successful in meeting the primary endpoint for blepharitis previously agreed upon with the U.S. Food and Drug Administration (FDA), the trial could represent the first of two pivotal trials needed to support a New Drug Application (NDA) in the U.S. The Mississippi trial is targeted to start in December 2020 with top-line results currently expected in Fourth Quarter 2021. NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, was evaluated in the successful Danube Phase 2 trial completed in late 2019. While not powered for efficacy, in the prospectively defined pooled analysis of once-daily and twice-daily dosing of NCX 4251 0.1%, there was a statistically significant reduction in the composite score of eyelid redness, eyelid debris and eyelid discomfort at day 14. Eyelid redness, eyelid debris and eyelid discomfort are the hallmark signs and symptoms of blepharitis. Announcement • Sep 24
Nicox Selects 0.1% NCX 470 Dose in Adaptive Stage of Mont Blanc Phase 3 Glaucoma Trial Nicox SA announced the selection of the 0.1% dose of NCX 470 for Phase 3 following the completion of the adaptive portion of the Mont Blanc Phase 3 clinical trial. As is customary for adaptive design trials, in order to maintain the integrity of the trial, no data from the adaptive portion of the trial will be disclosed until the completion of the trial. NCX 470, Nicox’s lead clinical product candidate, is a novel second generation nitric oxide (NO)-donating bimatoprost analog. NCX 470 is licensed to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets. Mont Blanc is a Phase 3 clinical trial evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. It was initiated on June 1, 2020, and currently has 48 clinical sites enrolling patients. Following the completion of the adaptive design portion of the trial announced September 23, 2020, Mont Blanc will continue as a multi-regional, double-masked, 3-month, parallel group trial evaluating the efficacy and safety of NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution, 0.005%, the most widely prescribed first-line therapy for glaucoma and ocular hypertension, randomized in a 1:1 ratio. The primary efficacy evaluation is based on time-matched IOP at 8 AM and 4 PM at Week 2, Week 6 and Month 3. The Mont Blanc trial is expected to randomize approximately 670 patients, at approximately 50 clinical sites in the U.S. and at a small number of clinical sites in China. At current recruitment rates, top-line results from Mont Blanc are expected in Fourth Quarter 2021. Is New 90 Day High Low • Sep 24
New 90-day low: €3.61 The company is down 13% from its price of €4.14 on 26 June 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 1.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Sep 18
Nicox SA Nicox Announces Senior Management Change Nicox SA announced a change in Nicox management. Dr. Tomas Navratil, PhD, Executive Vice President & Head of Research & Development of the Nicox Group and General Manager of Nicox Ophthalmics Inc. will be leaving Nicox on October 16, 2020 to pursue other opportunities. Announcement • Sep 11
Nicox S.A. to Report First Half, 2020 Results on Sep 10, 2020 Nicox S.A. announced that they will report first half, 2020 results on Sep 10, 2020 Announcement • Jul 10
GHO Capital Fund I LP managed by GHO Capital Partners LLP entered into an agreement to acquire remaining unknown minority stake in VISUfarma B.V from Nicox S.A. (ENXTPA:COX) for €5 million GHO Capital Fund I LP managed by GHO Capital Partners LLP entered into an agreement to acquire remaining unknown minority stake in VISUfarma B.V from Nicox S.A. (ENXTPA:COX) for €5 million on July 10, 2020. Under the terms of transaction, the stake consisted of shares in the UK holding company of VISUfarma and loan notes granted by VISUfarma B.V. Through this disinvestment, Nicox will focus on the rapid advancement of R&D pipeline to NDA submissions for two lead product candidates, NCX 470 and NCX 4251. The transaction is subject to certain approvals and is expected to close on or before July 23, 2020. Proceeds from sale will be used or strengthening cash position. 
