Press Release Nicox Announces Shareholder Q&A Webpage AvailableAugust 26, 2025 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that a new webpage “Q&A” is available on the company’s website, www.nicox.com, including information on the most frequently asked questions for shareholders in the form of a Q&A about Nicox and its business. The Q&A page can be reached here: Q&A Any investor questions can ...

Core Insights - Nicox SA announced positive results from the Phase 3 Denali trial for NCX 470, demonstrating non-inferiority in lowering intraocular pressure (IOP) compared to latanoprost [1][4][5] - The trial involved 696 patients and showed IOP reductions of 7.9 to 10.0 mmHg for NCX 470 versus 7.1 to 9.8 mmHg for latanoprost [1][5] - NCX 470 is expected to be submitted for New Drug Applications (NDAs) in the U.S. and China in H1 2026 [4][7] Company Overview - Nicox is an international ophthalmology company focused on innovative solutions for ocular health, with NCX 470 as its lead product candidate [16] - The company has established partnerships with Kowa and Ocumension Therapeutics to facilitate NDA preparations and potential future strategies [7][16] - Nicox's revenue streams include royalties from various products, including ZERVIATE® and VYZULTA® [16] Clinical Trial Details - The Denali trial was a randomized, multi-regional, double-masked study comparing NCX 470 0.1% to latanoprost 0.005% [10][11] - The primary efficacy evaluation was based on IOP reduction at multiple time points, confirming the efficacy profile required for regulatory submissions [11][14] - The trial also included a long-term safety extension, with NCX 470 showing a favorable safety profile [6][11] Financial Implications - Nicox will receive a €5 million milestone payment from Kowa based on the trial results, with potential royalties starting at 8% on net sales in the U.S. [12] - Total potential milestones under the agreement with Kowa are valued at €127 million [12] - Royalties of 6% to 12% on net sales are expected from the Chinese, Korean, and Southeast Asian markets due to the partnership with Ocumension [13]

Core Points - Nicox SA announced an extension of the PACEO equity line of financing with Vester Finance, allowing for an additional maximum of 5,000,000 shares, representing 6.43% of the currently issued share capital [1][3] - The company estimates it is financed into Q3 2026 based on current cash and debt positions, excluding proceeds from the new financing [2] - The total gross proceeds from the additional shares could potentially reach €3.1 million at the current share price [3] Financing Details - The financing agreement allows Vester Finance to subscribe for up to 5,000,000 additional shares under the same terms as previously announced [3] - A shareholder holding 1.00% of Nicox's capital before the transaction would see their stake reduced to 0.94% if the full extension is utilized [3] - The agreement can be terminated by the company at any time without penalty [3] Corporate Governance - The transaction was authorized by the CEO based on a delegation from the Board of Directors [4] - No prospectus is required to be submitted to the Autorité des marchés financiers (AMF) for this transaction [4] Shareholder Information - Vester Finance holds approximately 4% of Nicox's share capital and may sell shares over varying timeframes [5] - The company will announce the number of shares issued under this transaction on its website [6] Company Overview - Nicox SA is focused on developing innovative ophthalmology solutions, with its lead program being NCX 470, aimed at lowering intraocular pressure in glaucoma patients [8] - The company also has a preclinical research program on NCX 1728 and generates revenue from products like VYZULTA® and ZERVIATE® [8] - Nicox is listed on Euronext Growth Paris and is part of the CAC Healthcare index [9]

Core Viewpoint - Nicox SA's exclusive Japanese partner, Kowa, has initiated a Phase 3 safety clinical trial for NCX 470 in Japan, which will trigger a €2 million milestone payment to Nicox. This trial is part of the process to seek marketing approval for NCX 470 in Japan, requiring only one additional confirmatory Phase 3 trial [1][6]. Group 1: Clinical Trials and Development - Kowa is responsible for financing and managing the Phase 3 trials under a license agreement with Nicox, and the first patient has been enrolled in the safety trial [2][6]. - The confirmatory trial, involving 500 patients, is expected to start shortly and is necessary for the marketing approval submission [3]. - NCX 470 is currently in Phase 3 clinical development programs in the U.S., China, and Japan, aimed at lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension [4]. Group 2: Product Information - NCX 470 is a novel NO-donating bimatoprost eye drop, and its Phase 3 trials are designed to meet regulatory requirements for safety and efficacy to support NDA submissions in the U.S. and China [4]. - The results of the first Phase 3 clinical trial, Mont Blanc, have been published, and topline results from the second trial, Denali, are expected between mid-August and mid-September 2025 [4]. Group 3: Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for ocular health, with NCX 470 being its lead clinical product candidate [5]. - The company has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, in collaboration with Glaukos [5]. - Nicox's first product, VYZULTA®, is commercially available in the U.S. and over 15 other territories, and the company generates revenue from ZERVIATE® in allergic conjunctivitis [5].

Core Viewpoint - Nicox has signed a significant agreement with Kowa Company, granting exclusive rights for the development and commercialization of NCX 470, a glaucoma treatment, in the U.S. and other unlicensed territories, potentially worth up to €191.5 million [1][2][3] Agreement Details - The agreement includes an upfront payment of €7.5 million, with additional milestone payments based on the results of the Denali clinical trial and the submission of a New Drug Application (NDA) to the FDA, which is expected in H2 2026 [2][6] - Total potential milestone payments could reach either €127 million or €191.5 million, depending on the Denali trial outcomes, along with tiered royalties of up to 20% in the U.S. [5][7] Financial Implications - 70% of the upfront payment will be used to partially repay Nicox's debt, reducing it to €9.6 million, with an estimated cash position of €5.9 million as of June 30, 2025, allowing for over 12 months of cash runway [10] Market Context - The glaucoma pharmaceutical market is valued at over $7 billion, with the U.S. market accounting for approximately 40% and expected to grow at a CAGR of 3% to 5% [11] Product Overview - NCX 470 is a novel nitric oxide-donating bimatoprost eye drop currently in Phase 3 clinical development for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension [12][13]

Core Insights - Nicox SA has announced the completion of the last patient visit in the Denali Phase 3 clinical trial for NCX 470, a treatment for open-angle glaucoma and ocular hypertension [1][3] - The trial enrolled a total of 696 patients, with topline results expected between mid-August and mid-September 2025 [2][6] - NCX 470 is a novel NO-donating bimatoprost eye drop aimed at lowering intraocular pressure, and the trial compares its efficacy to latanoprost [3][6] Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for ocular health [5][7] - The company is headquartered in Sophia Antipolis, France, and is listed on Euronext Growth Paris [8] Future Milestones - Topline results from the Denali trial are anticipated in mid-August to mid-September 2025 [6] - A New Drug Application (NDA) submission for NCX 470 in the U.S. is targeted for the first half of 2026, contingent on securing a U.S. partner or necessary funding [5][6] - Initiation of NCX 470 Phase 3 clinical trials in Japan is expected in the second half of 2025 [6]

Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for vision maintenance and ocular health [7] - The company's lead program is NCX 470, a nitric oxide-donating bimatoprost eye drop aimed at lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension [7] - Nicox's first product, VYZULTA®, is commercially available in the U.S. and over 15 other territories, licensed exclusively to Bausch + Lomb [7] - The company also generates revenue from ZERVIATE® for allergic conjunctivitis, licensed in multiple regions including the U.S. and China [7] Shareholders' Meeting - The Ordinary and Extraordinary General Meeting is scheduled for June 27, 2025, at 2:30 p.m. at the company's headquarters in Sophia Antipolis, France [1] - The agenda and draft resolutions for the meeting were published in the Official Bulletin of Mandatory Legal Announcements [2] - An ad hoc representative has been appointed to represent defaulting shareholders due to difficulties in reaching the required quorum [3] - The ad hoc representative will ensure that the quorum reaches 100% of shares with voting rights [4] Voting Process - Shareholders can vote by proxy, internet, or in person at the meeting [5] - A guide for voting, including internet voting instructions, is available on the company's website [5] - Voting requirements include half the votes in favor for ordinary resolutions and two-thirds in favor for extraordinary resolutions proposed by the Board of Directors [6]

Core Viewpoint - Nicox SA announced positive results from the Whistler Phase 3b exploratory trial for NCX 470, indicating its potential as a differentiated treatment for lowering intraocular pressure (IOP) in patients with glaucoma and ocular hypertension [1][2][3]. Group 1: Trial Results - The Whistler trial demonstrated that NCX 470 showed favorable outcomes in several aqueous humor dynamics parameters, attributed to its dual mechanism of action involving nitric oxide and prostaglandin analogs [2][3]. - Statistically significant results were observed for IOP lowering and uveoscleral outflow at all measured time points, with outflow facility showing significance at 3 pm (p=0.001) and diurnal outflow at p=0.004 [3][5]. - The trial involved 18 healthy volunteers with mean baseline IOPs of 16.6 mmHg for NCX 470 and 16.9 mmHg for placebo, indicating a normotensive population [4][5]. Group 2: Future Developments - The ongoing Phase 3 trial, Denali, is expected to provide further safety and efficacy results in Q3 2025, which will support New Drug Application submissions in the U.S. and China [2][7]. - The safety profile of NCX 470 in the Whistler trial was consistent with the earlier Mont Blanc trial, which has already demonstrated its efficacy [3][5]. Group 3: Company Overview - Nicox SA is focused on developing innovative ophthalmic solutions, with NCX 470 being its lead product candidate for lowering IOP in open-angle glaucoma and ocular hypertension [8]. - The company also has a preclinical program for NCX 1728 and generates revenue from its commercial product, VYZULTA®, and ZERVIATE® [8].