Ankündigung • Aug 10
Nicox Sa and Ocumension Therapeutics Submit Ncx 470 New Drug Application in China Nicox SA announced that its exclusive licensee in China, Ocumension Therapeutics, has submitted the New Drug Application (NDA) for NCX 470 as a treatment to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The NDA includes the Phase 3 program of both the Mont Blanc trial, and the Denali trial, which specifically included Chinese clinical sites, allowing the program to complete the clinical requirements for approval in China, the same data as recently submitted to the U.S. FDA. Ocumension has already successfully obtained approval for a number of ophthalmology products in China. Ocumension has paid Nicox license fees of EUR 18 million for the rights to develop and commercialise NCX 470 in the Chinese, Korean and Southeast Asian markets, contributed 50% of the Denali clinical trial costs and is one of Nicox’s principal shareholders. Nicox will receive tiered royalties on sales of NCX 470 made by Ocumension ranging from 6% to 12%. Ocumension already has an ophthalmology sales force in place throughout China and is therefore well-positioned for a rapid launch of NCX 470. There is no fixed period for approval of a pharmaceutical product in China, however these are frequently granted in 12 to 18 months following submission. The approval of NCX 470 in China is expected after the approval in the US, where Nicox’s partner Kowa recently submitted an NDA. Breakeven Date Change • Jul 02
Forecast breakeven date pushed back to 2027 The analyst covering Nicox previously expected the company to break even in 2026. New forecast suggests the company will make a profit of €1.00m in 2027. Average annual earnings growth of 54% is required to achieve expected profit on schedule. Ankündigung • Jul 01
Nicox Submits NCX 470 New Drug Application In The United States Nicox SA announced the submission of an NDA to the FDA for NCX 470 (also known as K-911), by exclusive U.S. licensee, Kowa. NCX 470 (bimatoprost grenod), Nicox’s lead clinical product candidate, is a novel nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The NDA submission is supported by positive results from the Mont Blanc and Denali Phase 3 clinical trials, which together were designed to meet regulatory requirements for efficacy and safety in support of approval in the United States and in China. These trials demonstrated that NCX 470 achieved clinically meaningful reductions in IOP with a favorable safety profile. The NCX 470 NDA is expected to be the subject of a standard 12-month review period, which would lead to approval in mid-2027, and an expected commercial launch in the U.S. before the end of 2027. Launch of NCX 470 will bring a new, sustainable and recurrent revenue stream to the Company. NCX 470 is part of Nicox’s global partnering strategy. In addition to the U.S., Kowa holds exclusive rights to develop and commercialize NCX 470 in Japan, where it has significant experience in glaucoma and a strong commercial presence, and in all other countries outside the Chinese market, South Korea and Southeast Asia. Phase 3 clinical trials on NCX 470 were initiated in Japan in the summer of 2025. Ocumension Therapeutics holds exclusive rights for China, where regulatory submission activities are expected to soon follow this U.S. filing. These partnerships position NCX 470 for potential commercialization in key global markets. Nicox may receive regulatory and sales milestones and royalties on worldwide sales. All regulatory and commercialization costs are borne by Kowa and Ocumension. Live-News • Jul 01
Nicox Receives €3 Million Milestone as Kowa Files NCX 470 NDA with US FDA Nicox reported that its licensee Kowa has submitted a New Drug Application to the US FDA for glaucoma candidate NCX 470, triggering a €3 million milestone payment to Nicox, with another milestone expected upon potential approval.
The NDA is backed by positive Phase 3 Mont Blanc and Denali trial data in open-angle glaucoma and ocular hypertension, indicating that NCX 470 has cleared a key development hurdle in the US regulatory process.
Nicox shares trade at €0.38, with the stock up 20.8% year to date.
The NDA filing moves NCX 470 from a development-stage asset into formal FDA review. This concentrates attention on regulatory timelines and any approval conditions, while the milestone inflow modestly strengthens Nicox’s cash position and increases the importance of execution by partner Kowa. Ankündigung • Jun 18
Nicox Announces Positive Pre-Submission Regulatory Feedback in China Supporting NDA Filing for NCX 470 Nicox SA announced that its exclusive licensee in China, Ocumension Therapeutics, has received positive pre-submission regulatory feedback from the Chinese Center for Drug Evaluation for NCX 470. Ocumension considers the feedback is sufficient to proceed with the submission of the dossier for marketing approval of NCX 470 to the Chinese National Institutes for Food and Drug Control. NCX 470 (bimatoprost grenod) is a novel nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Based on this feedback, Ocumension intends to proceed with the New Drug Application (NDA) submission in China. Submission should follow shortly after NCX 470 NDA to the U.S. Food and Drug Administration (FDA), expected summer 2026. NCX 470 is licensed globally to Kowa, except in the Chinese market, South Korea and Southeast Asia, where it is licensed to Ocumension Therapeutics. Nicox may receive regulatory and sales milestones and will be paid royalties on worldwide sales. All regulatory and commercialisation costs are borne by Kowa and Ocumension. NCX 470 NDA submission in the United States: expected in summer 2026. NCX 470 NDA submission in China: expected shortly after submission in the U.S. NCX 470 Phase 3 clinical program in Japan: initiated in summer 2025. Price Target Changed • Jun 07
Price target decreased by 33% to €1.00 Down from €1.50, the current price target is provided by 1 analyst. New target price is 167% above last closing price of €0.37. Stock is up 65% over the past year. The company is forecast to post earnings per share of €0.01 next year compared to a net loss per share of €0.03 last year. Ankündigung • 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 Ankündigung • 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. New Risk • Feb 11
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of French stocks, typically moving 6.7% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Negative equity (-€4.8m). Minor Risks Share price has been volatile over the past 3 months (6.7% average weekly change). Shareholders have been diluted in the past year (28% increase in shares outstanding). Revenue is less than US$5m (€3.3m revenue, or US$3.9m). Market cap is less than US$100m (€32.7m market cap, or US$38.9m). Ankündigung • 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. New Risk • Oct 26
New major risk - Negative shareholders equity The company has negative equity. Total equity: -€4.8m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (14% average weekly change). Negative equity (-€4.8m). Minor Risks Shareholders have been diluted in the past year (18% increase in shares outstanding). Revenue is less than US$5m (€3.3m revenue, or US$3.9m). Market cap is less than US$100m (€29.3m market cap, or US$34.1m). New Risk • Sep 17
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 21% 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: Major Risk Share price has been highly volatile over the past 3 months (17% average weekly change). Minor Risks Shareholders have been diluted in the past year (21% increase in shares outstanding). Market cap is less than US$100m (€28.0m market cap, or US$33.1m). Ankündigung • 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. Ankündigung • 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. New Risk • Jul 17
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 11% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. 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 (11% average weekly change). Minor Risk Market cap is less than US$100m (€21.8m market cap, or US$25.3m). New Risk • Jul 09
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 Risk Latest financial reports are more than 1 year old (reported June 2023 fiscal period end). Minor Risk Market cap is less than US$100m (€16.3m market cap, or US$19.1m). Ankündigung • 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. Ankündigung • 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 Ankündigung • 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. New Risk • May 05
New major risk - Revenue and earnings growth Earnings have declined by 1.3% per year over the past 5 years. 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 declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. 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 Earnings have declined by 1.3% per year over the past 5 years. Shareholders have been substantially diluted in the past year (38% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (€16m net loss next year). Market cap is less than US$100m (€16.1m market cap, or US$18.2m). Ankündigung • 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 • Jan 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 38% This is considered a major 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: 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 (11% average weekly change). Shareholders have been substantially diluted in the past year (38% increase in shares outstanding). Minor Risk Market cap is less than US$100m (€20.9m market cap, or US$21.5m). New Risk • Dec 27
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 (11% 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 (38% increase in shares outstanding). Revenue is less than US$5m (€3.6m revenue, or US$3.7m). Market cap is less than US$100m (€19.5m market cap, or US$20.3m). 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 (22% 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). New Risk • Sep 19
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (16% average weekly change). 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 over next 2 years (€12m 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$4.0m). Market cap is less than US$100m (€15.5m market cap, or US$17.3m). Ankündigung • 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. Ankündigung • 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 (6.7% 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). Ankündigung • 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). 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). Ankündigung • 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. Ankündigung • 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 (12% 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). New Risk • Nov 01
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. 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 (12% average weekly change). Earnings are forecast to decline by an average of 7.7% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable next year (€18m 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 (€17.3m market cap, or US$18.2m). 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 20% growth forecast for the Biotechs industry in France. 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 54% per year, which means it is significantly lagging earnings. New Risk • Oct 22
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 Risk 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). Ankündigung • 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 24
Full year 2022 earnings released Full year 2022 results: Net loss: €27.8m (loss narrowed 37% from FY 2021). Ankündigung • 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 Major Estimate Revision • Jan 20
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from €8.89m to €14.8m. EPS estimate fell from -€0.53 to -€0.54 per share. Biotechs industry in France expected to see average net income decline 11% next year. Consensus price target of €9.50 unchanged from last update. Share price fell 5.2% to €1.06 over the past week. Ankündigung • 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. Major Estimate Revision • Sep 23
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from €2.95m to €2.98m. Forecast EPS reduced from -€0.47 to -€0.65 per share. Biotechs industry in France expected to see average net income growth of 8.6% next year. Consensus price target of €12.00 unchanged from last update. Share price fell 4.9% to €1.79 over the past week. 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 27% growth forecast for the Biotechs industry in France. Reported Earnings • May 01
Full year 2021 earnings: EPS exceeds analyst expectations 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). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 100%. Over the next year, revenue is forecast to grow 38%, compared to a 367% growth forecast for the pharmaceuticals industry in France. 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. Price Target Changed • Apr 27
Price target decreased to €11.50 Down from €13.83, the current price target is an average from 3 analysts. New target price is 585% above last closing price of €1.68. Stock is down 60% over the past year. The company is forecast to post a net loss per share of €0.57 next year compared to a net loss per share of €0.54 last year. Price Target Changed • Dec 14
Price target decreased to €11.67 Down from €14.17, the current price target is an average from 3 analysts. New target price is 349% above last closing price of €2.60. Stock is down 39% over the past year. The company is forecast to post a net loss per share of €0.63 next year compared to a net loss per share of €0.54 last year. 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). 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. 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). Is New 90 Day High Low • Nov 13
New 90-day high: €4.11 The company is up 1.0% from its price of €4.06 on 14 August 2020. The French market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 15% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Oct 29
New 90-day low: €3.28 The company is down 8.0% from its price of €3.58 on 30 July 2020. The French market is down 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Oct 06
New 90-day low: €3.55 The company is down 14% from its price of €4.11 on 07 July 2020. The French market is down 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 7.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.