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Nicox Announces Conference Attendance in H1 2026 and Upcoming Scientific Data Presentations
Globenewswire· 2026-01-20 06:30
Core Viewpoint - Nicox SA, an international ophthalmology company, announced its participation in several key conferences in the first half of 2026, including significant scientific data presentations at the American Glaucoma Society Annual Meeting [1][2]. Conference Attendance - Nicox will attend multiple conferences, including the Allinvest securities Biomed Forum on January 29, 2026, in Paris, the MidCap Event on February 5, 2026, in Frankfurt, and the Association for Research in Vision and Ophthalmology Annual Meeting from May 3-7, 2026, in Denver [7]. Scientific Data Presentations - At the American Glaucoma Society Annual Meeting, Nicox will present data from the NCX 470 studies, specifically the Denali and Whistler studies [2]. Company Overview - Nicox is focused on developing innovative solutions for ocular health, with its lead product being NCX 470, a nitric oxide-donating eye drop aimed at lowering intraocular pressure in glaucoma patients [5]. - The company has licensed NCX 470 to Ocumension Therapeutics for specific Asian markets and to Kowa for the rest of the world [5]. - Nicox's first product, VYZULTA®, is commercially available in the U.S. and over 15 other territories, and the company also generates revenue from ZERVIATE® for allergic conjunctivitis [5].
Nicox Announces Complete Repayment of Kreos Capital Debt and Extends Cash Runway Beyond 2027 with New Additional Financing
Globenewswire· 2026-01-05 06:30
Core Viewpoint - Nicox has fully repaid its secured debt to Kreos Capital and has secured additional financing, extending its cash runway beyond 2027, which positions the company for future strategic growth opportunities [1][2][5]. Debt Repayment - Nicox has repaid all outstanding debt of €20 million to Kreos Capital, releasing all security interests over its assets and terminating Kreos Capital's right to appoint an Observer to the Board of Directors [2][9]. - As of December 31, 2025, Nicox's remaining debt was €0.3 million, which is a COVID loan expected to be repaid by the end of August 2026 [10]. New Financing - The company has secured up to €4 million in additional unsecured financing through the issuance of €3 million in convertible bonds and €1 million in ordinary bonds, which will extend its cash runway beyond 2027 [2][5][11]. - The convertible bonds were issued at 92% of their nominal value, while the ordinary bonds were subscribed at 100% of their nominal value [12][13]. Strategic Positioning - The repayment of Kreos Capital debt and the new financing enhance Nicox's financial flexibility, allowing for better resource management and strategic discussions [2][5]. - Nicox is evaluating future strategic growth opportunities, including potential collaborations or business combinations [3]. Future Milestones - The company plans to submit an NCX 470 New Drug Application in the U.S. in summer 2026, with submissions in China expected shortly thereafter [6]. - The NCX 470 Phase 3 clinical program in Japan was initiated in summer 2025, managed and financed by Kowa [6]. Cash Runway - The financing and debt repayment allow Nicox to finance its current activities beyond the end of 2027, with a commitment to cost control and resource optimization [7]. - Potential proceeds from existing warrants and the additional bond financing are not included in the cash runway calculation [8].
Nicox Completes NCX 470 New Drug Application Key Data Generation for Submission as Planned in H1 2026
Globenewswire· 2025-12-16 06:30
Core Insights - Nicox SA has successfully completed the generation and analysis of all key data required for New Drug Applications (NDAs) in the U.S. and China, including clinical trial and long-term stability data for the NCX 470 drug material and finished product [1][5][6] - The company is preparing for a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) and plans to submit the NDA in the first half of 2026, with the Chinese submission expected shortly thereafter [5][6] Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for vision maintenance and ocular health, with its lead product being NCX 470, a nitric oxide-donating eye drop for lowering intraocular pressure in glaucoma patients [4][7] - The company has licensing agreements for NCX 470 with Ocumension Therapeutics for the Chinese, Korean, and Southeast Asian markets, and with Kowa for the rest of the world [4][6] Future Milestones - The NDA submission for NCX 470 in the U.S. is on track for H1 2026, with the submission in China expected to follow shortly after [5][6] - A Phase 3 clinical program for NCX 470 has been initiated in Japan, managed and financed by Kowa [6]
Nicox’s NCX 470 Demonstrates Sustained Efficacy through 12 Months in Denali Clinical Trial with no new Safety Observations
Globenewswire· 2025-10-02 05:30
Core Insights - Nicox SA has completed additional pre-planned analyses of the NCX 470 Denali Phase 3 clinical trial, confirming sustained efficacy in reducing intraocular pressure (IOP) over 12 months with no new safety observations [1][6][8] - The company is preparing New Drug Applications (NDAs) for NCX 470 in the U.S. and China, with submissions expected in H1 2026 for the U.S. and shortly thereafter for China [2][7] - Nicox plans to present further data at upcoming ophthalmology conferences [3] Clinical Trial Details - The Denali trial is a randomized, multi-regional, double-masked, parallel group study involving 696 patients across 90 sites in the U.S. and China, comparing NCX 470 to latanoprost [5] - NCX 470 demonstrated robust IOP reduction at 6, 9, and 12 months, aligning with trends observed in the Mont Blanc trial [6] Future Plans - The Phase 3 clinical program for NCX 470 in Japan was initiated in summer 2025, managed and financed by Kowa [7] - Nicox's lead product, NCX 470, is a nitric oxide-donating bimatoprost eye drop aimed at treating open-angle glaucoma or ocular hypertension [9]
Nicox Announces Shareholder Q&A Webpage Available
Globenewswire· 2025-08-26 05:30
Core Points - Nicox SA has launched a new "Q&A" webpage on its website to address frequently asked questions from shareholders [1] - The company is focused on developing innovative ophthalmology solutions to maintain vision and improve ocular health [2] Company Overview - Nicox SA is an international ophthalmology company headquartered in Sophia Antipolis, France, and is listed on Euronext Growth Paris under the ticker symbol ALCOX [3] - The company's lead clinical 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 [2] - Nicox has licensed NCX 470 to Ocumension Therapeutics for the Chinese, Korean, and Southeast Asian markets, and to Kowa for the rest of the world [2] - The company also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, in collaboration with Glaukos [2] - Nicox's first product, VYZULTA®, is commercially available in the U.S. and over 15 other territories, licensed exclusively worldwide to Bausch + Lomb [2] - The company generates revenue from ZERVIATE® for allergic conjunctivitis, licensed in multiple geographies [2]
Nicox Announces Positive Results from the NCX 470 Phase 3 Denali Trial in Glaucoma Patients
Globenewswire· 2025-08-21 05:30
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]
Nicox Extends Existing Flexible Equity Financing
Globenewswire· 2025-08-08 05:30
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]
Nicox’s Partner Kowa Initiates NCX 470 Phase 3 Clinical Trial in Japan
Globenewswire· 2025-08-05 05:30
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].
Nicox and Kowa Sign Key Agreement worth up to €191.5 million for Exclusive Rights to Glaucoma Treatment NCX 470 in U.S. and all Unlicensed Territories
Globenewswire· 2025-07-17 05:30
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]
Nicox Announces Last Patient Completes the NCX 470 Denali Phase 3 Clinical Trial
Globenewswire· 2025-06-30 05:30
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]