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Business Wire
17-07-2025
- Business
- Business Wire
GenSight Biologics Announces an Additional Financing Amounting to Approximately EUR 500,000 from Existing Shareholder
PARIS--(BUSINESS WIRE)--Regulatory News: This additional financing provides valuable flexibility as we execute our operational roadmap through October 2025. NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, CANADA, AUSTRALIA, JAPAN AND SOUTH AFRICA GenSight Biologics (the " Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced a financing through a capital increase reserved to an existing shareholder by the issuance of new shares with warrants attached, for a total gross amount of EUR 499,999.92 (excluding the future net proceeds related to the exercise of the warrants) (the " Reserved Offering"). The subscription price for one ABSA is EUR 0.17 (the " Offering Price"). This follows the approximately EUR 4 million financing announced on July 1, 2025 (the ' Early July Financing '). The Offering Price of the ABSA and the terms and conditions of the warrants, including their exercise price, are identical to those included in the Early July Financing. " We are delighted to receive this additional support from an existing shareholder, as we continue to pursue GenSight's strategic direction and LUMEVOQ's potential, ' commented Laurence Rodriguez, Chief Executive Officer of GenSight Biologics. " This supplementary funding, combined with our recent EUR 4 million financing, strengthens our position as we advance toward the anticipated opening of the French AAC program in Q4 2025 and prepare for our global Phase III RECOVER study." The New Shares (as defined below) represent less than 30% of the total number of the Company's ordinary shares already admitted to trading on Euronext Paris. The admission to trading of the New Shares on Euronext Paris is therefore exempted from the obligation to prepare a prospectus. Use of Proceeds The proceeds of the Reserved Offering will supplement the funds raised in the Early July Financing. Together, they are intended to be used principally to finance the continued development of LUMEVOQ ®, the Company's most advanced drug candidate, currently in Phase III. In particular, the funds raised will help ensure the Company's operational continuity, support the finalization of manufacturing transfer activities and secure the preparations for the anticipated opening of compassionate use access in France as well as the initiation of the Phase III study RECOVER. The balance will be used to meet certain financial obligations of the Company. This will extend the Company's cash runway from mid-July 2025 before the Early July Financing to early-October 2025 initially and now to mid-October 2025. " This additional financing provides valuable flexibility as we execute our operational roadmap through October 2025, ' noted Jan Eryk Umiastowski, Chief Financial Officer of GenSight Biologics. " We believe the support of UPMC Enterprises reflects the attractiveness of our investment proposition. We remain focused on achieving key regulatory milestones that will establish a sustainable revenue pathway, beginning with the AAC program." Terms and Conditions of the Reserved Offering The Reserved Offering, for a total of EUR 499,999.92 (share issue premium included), was carried out through the issuance of 2,941,176 ABSA (as defined below) via a capital increase without shareholders' preferential subscription rights reserved to a category of persons satisfying determined characteristics, pursuant to Article L. 225-138 of the French Commercial Code, through the issuance of new shares of a per value of EUR 0.025 (the " New Shares"), to which are attached 1 warrant for 1 new share (the " Warrants", together with the New Shares, the " ABSA" and with the new shares of the Company resulting from the exercise of the Warrants, the " Warrant Shares"). The launch of the Reserved Offering was decided on July 16, 2025 by the Chief Executive Officer, pursuant to the delegation of competence granted to her by the Company's board of directors (the ' Board of Directors ') on June 19 and June 30, 2025. The Board of Directors acted pursuant to the delegation of competence granted to it under the 24 th resolution of the Company's shareholders on May 13, 2025 (the ' General Meeting '). The EUR 0.17 issue price on one ABSA represents a facial premium of EUR 0.0492 to the closing price of the GenSight shares on Euronext Paris on the day of the determination of the issue price, i.e., EUR 0.1208 on July 16, 2025. The exercise price of the Warrants is EUR 0.21. The Warrants will be exercisable at any time from their issue date until July 21, 2030. The exercise of a Warrant will give the right to subscribe to one (1) Warrant Share (the " Exercise Ratio"), it being specified that this Exercise Ratio may be adjusted following any transactions carried out by the Company on its share capital or reserves, as from the issuance date of the Warrants, in order to maintain the rights of the Warrants' holders. Impact of the Reserved Offering on the Company's Shareholding Following the issuance of the New Shares, the Company's total share capital will be EUR 3,891,473.45 (composed of 155,658,938 ordinary shares). If all the Warrants are exercised, and thus all the Warrant Shares issued, the Company's total share capital will be EUR 3,965,002.85 (composed of 158,600,114 ordinary shares). Please see sections 19.1.3 and 19.1.4 of the Company's 2024 Universal Registration Document and the press release dated July 1, 2025 relating to the Early July Financing for a description of the securities issued by GenSight and giving access to its capital. For illustration purposes, the impact of the issuance of the New Shares and the Warrant Shares on the ownership of a shareholder holding 1% of the Company's share capital prior to the Reserved Offering and not subscribing to it, is as follows: Impact of the Reserved Offering on Shareholders' Equity For illustration purposes, the impact of the issuance of the New Shares and the Warrant Shares on the Company's equity per share (calculation made on the basis of the Company's shareholders' equity as reflected in the consolidated financial statements as of December 31, 2024, adjusted for the capital increase of March 7, 2025, the conversion of 631,560 Heights convertible bonds into 1,930,195 new shares on April 1, 2025, in accordance with the amendment dated June 27, 2024 to the convertible bond agreement, and the capital increase of July 1, 2025) is as follows: Evolution of the Shareholding Structure following the Reserved Offering To the Company's knowledge, immediately prior to completion of the Reserved Offering, the breakdown of the Company's share capital was as follows: Shareholders Shareholding (non-diluted) Shareholding (diluted) 3 Number of shares and voting rights % of share capital and voting rights Number of shares and voting rights % of share capital and voting rights 5% Shareholders Sofinnova 4 35,795,627 23.4 % 53,106,527 20.4 % Invus 5 21,512,773 14.1 % 30,535,967 11.7 % UPMC Enterprises 6 10,158,364 6.7 % 12,487,477 4.8 % Heights 7 14,900,613 9.8 % 70,347,580 27.1 % BPI 3,877,591 2.5 % 5,355,501 2.1 % Directors and Officers 517,002 0.3 % 2,388,335 0.9 % Employees 352,500 0.2 % 392,500 0.2 % Other shareholders (total) 65,603,292 43.0 % 85,398,945 32.8 % Total 152,717,762 100.00 % 260,012,832 100.00 % Expand To the Company's knowledge, immediately after the completion of the Reserved Offering and the issuance of the New Shares, the breakdown of the Company's share capital will be as follows: Shareholders Shareholding (non-diluted) Shareholding (diluted) Number of shares and voting rights % of share capital and voting rights Number of shares and voting rights % of share capital and voting rights 5% Shareholders Sofinnova 35,795,627 23.0 % 53,106,527 20.0 % Invus 21,512,773 13.8 % 30,535,967 11.5 % UPMC Enterprises 13,099,540 8.4 % 18,369,829 6.9 % Heights 14,900,613 9.6 % 70,347,580 26.5 % BPI 3,877,591 2.5 % 5,355,501 2.0 % Directors and Officers 517,002 0.3 % 2,388,335 0.9 % Employees 352,500 0.2 % 392,500 0.1 % Other shareholders (total) 65,603,292 42.1 % 85,398,945 32.1 % Total 155,658,938 100.0 % 265,895,184 100.0 % Expand To the Company's knowledge, after the completion of the Reserved Offering and the issuance of the New Shares and all Warrant Shares upon exercise of all Warrants, the breakdown of the Company's share capital will be as follows: Shareholders Shareholding (non-diluted) Shareholding (diluted) Number of shares and voting rights % of share capital and voting rights Number of shares and voting rights % of share capital and voting rights 5% Shareholders Sofinnova 35,795,627 22.6 % 53,106,527 20.0 % Invus 21,512,773 13.6 % 30,535,967 11.5 % UPMC Enterprises 16,040,716 10.1 % 18,369,829 6.9 % Heights 14,900,613 9.4 % 70,347,580 26.5 % BPI 3,877,591 2.4 % 5,355,501 2.0 % Directors and Officers 517,002 0.3 % 2,388,335 0.9 % Employees 352,500 0.2 % 392,500 0.1 % Other shareholders (total) 65,603,292 41.4 % 85,398,945 32.1 % Total 158,600,114 100.0 % 265,895,184 100.0 % Expand Admission to Trading of the New Shares and the Warrants Settlement-delivery of the Reserved Offering and the admission of the New Shares to trading on the regulated market of Euronext Paris are expected on July 21, 2025. The New Shares and the Warrant Shares will be subject to the provisions of the Company's by-laws and will be assimilated to existing shares upon final completion of the Reserved Offering. They will bear current dividend rights and will be admitted to trading on the same listing line as the Company's existing shares under the same ISIN code FR0013183985 / SIGHT. The Warrants are expected to be admitted to trading on the Euronext Growth market in Paris (" Euronext Growth Paris") on July 21, 2025 on the same warrant listing line as the Company's existing warrants under the same ISIN code FR0014010IB4/SIGBS. The Warrant Shares will be admitted to trading on Euronext Paris as they are issued following the exercise of the corresponding warrants. Lock-up Commitments The benefit of the lock-up commitments agreed by the Company (45 days) and directors and officers of the Company (60 days) has been extended to UPMC Enterprises. Indicative Timetable July 16, 2025 Decision of the Chief Executive Officer setting the terms and conditions of the Reserved Offering. July 17, 2025 Publication of this press release. July 18 or 21, 2025 Publication of the Euronext notice of admission of the New Shares to trading on Euronext Paris. July 21, 2025 Settlement-delivery of the ABSAs - Detachment of the Warrants - Start of trading of the New Shares on Euronext Paris. Admission of the Warrants on Euronext Growth Paris Expand Risk Factors The Company draws the attention of the public to the risk factors relating to the Company and its business described in its 2024 Universal Registration Document, as updated in the Information Document made available in connection with the Early July Financing, which are available free of charge on the Company's website ( . In addition, the main risks specific to securities are as follows: The existing shareholders who do not participate in the Reserved Offering will see their shareholding in the share capital of GenSight diluted, and this shareholding may also be further diluted in the event of the exercise of the Warrants, as well as in the event of new securities transactions. The volatility and liquidity of GenSight shares could fluctuate significantly. The market price of the Company's shares may fluctuate and fall below the subscription price of the shares issued in the context of the Reserved Offering. The sale of Company shares may occur on the secondary market, after the Reserved Offering, and have a negative impact on the Company share price. About GenSight Biologics S.A. GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics' pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. Disclaimer Not for release, directly or indirectly, in or into the United States of America, Canada, Australia, Japan or South Africa. This press release and the information contained herein do not contain or constitute an offer to subscribe or purchase, or the solicitation of an order to purchase or subscribe, for securities in the United States of America or in any other jurisdiction where such an offer or solicitation would be unlawful. The securities referred to herein have not been and will not be registered under the Securities Act, or under the securities laws of any state or other jurisdiction of the United States of America, and may not be offered or sold in the United States of America except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with the securities laws of any state or any other jurisdiction of the United States. GenSight does not intend to make a public offering of the securities in the United States of America. The distribution of this press release may be subject to legal or regulatory restrictions in certain countries. Persons in possession of this press release should inform themselves of and observe any local restrictions. The information contained herein is subject to change without notice. Forward-Looking Statements This press release contains forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the completion expected proceeds and anticipated use of proceeds of the Reserved Offering; the anticipated cash runway of the Company; and future expectations, plans and prospects of the Company. Words such as 'anticipates,' 'believes,' 'expects,' 'intends,' 'projects,' and 'future' or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the proposed securities offering discussed above will be consummated on the terms described or at all. Completion of the proposed Reserved Offering and the terms thereof are subject to numerous factors, many of which are beyond the control of the Company, including, without limitation, market conditions, failure of customary closing conditions and the risk factors and other matters set forth in the filings the Company makes with the Autorité des marchés financiers from time to time. The Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law. 1 The number of shares contained in the table includes 107,295,070 shares that may be issued by the Company further to the exercise of the remaining share warrants, founders share warrants, free shares and stock options outstanding, including the share warrants issued as part of the Early July Financing. 2 Idem. 3 Idem. 4 Sofinnova Partners: French management company located at 7-11 boulevard Haussmann, 75009 Paris, France, which manages Sofinnova Crossover I SLP. 5 Invus: a Bermudian company located at Clarendon House, 2 Church Street, Hamilton HM 11 Bermuda. Pursuant to the provisions of Article L. 233-9 I, 4° bis of the French Commercial Code, Invus has stated that they hold 6,360,058 shares of GENSIGHT BIOLOGICS S.A. as a result of holding "contracts for differences" ("CFDs") maturing on January 3, 2034, covering an equivalent number of GENSIGHT BIOLOGICS S.A. shares, to be settled in cash. 6 UPMC Enterprises: a non-profit organization located at 6425 Penn Avenue, Suite 200, Pittsburgh, Pennsylvania, United States of America. 7 Heights Capital: a Cayman Islands exempted company located at PO Box 309GT, Ugland House South Church Street, George Town Grand Cayman, Cayman Islands.
Associated Press
08-07-2025
- Business
- Associated Press
GenSight Biologics Reports Cash Position as of June 30, 2025
PARIS--(BUSINESS WIRE)--Jul 8, 2025-- Regulatory News: GenSight Biologics (" GenSight Biologics " or the " Company ") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its cash position as of June 30, 2025. 'The second quarter of 2025 marked a period of significant operational progress for GenSight Biologics. We successfully completed the technology transfer of LUMEVOQ's upstream manufacturing process to our new partner Catalent, secured the ANSM's agreement to consider opening the AAC program in France, and closed our private placement financing in July, ' commented Jan Eryk Umiastowski, CFO of GenSight Biologics. ' We continue to actively pursue non-dilutive financing options to support our critical value-driving activities. With the AAC program launch planned for Q4 2025, we have established a clear financial pathway through H2 2026, when we expect to initiate our Phase III RECOVER trial and submit our marketing application to the MHRA of the UK.' Cash position as of June 30, 2025 GenSight Biologics' cash and cash equivalents totaled €0.3 million as of June 30, 2025, compared to €0.9 million as of March 31, 2025. With the equity-with-warrants-attached and pre-funded warrants financing announced on July 1, 2025 (approximately €3.9 million) and the anticipated collection of approximately additional €0.2 million in Research Tax Credit (CIR) in September, and based on current operations, plans, and assumptions, this balance should fund operations until early October 2025. EUR 0.7 million of the proceeds from the financing has been used for the repayment in principal on the convertible bonds held by Heights Capital through offset against their subscription. The funds are insufficient to cover operational requirements for the next 12 months. However, the anticipated opening of the AAC program in France in Q4 2025 (targeted for October) will establish a clear cash pathway until H2 2026, when the company expects to initiate the RECOVER Phase III clinical trial and to submit the UK MHRA marketing application for LUMEVOQ ®. The company is pursuing strategic options that could generate funds for the Phase III trial and UK regulatory submission. These include: In the first quarter of 2026, the company will have a precise view of residual financing needs and will make a strategic decision on additional financing modalities. If necessary, GenSight Biologics may access financial markets. Options in the medium term include partnering or M&A arrangements. Recapitulation of Recent Milestones Number of outstanding shares As of July 8, 2025, GenSight Biologics' number of outstanding shares was 152,717,762 ordinary shares. Financial Agenda The Company will report its interim H1 financial results by the end of September 2025. About GenSight Biologics S.A. GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics' pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. Forward-Looking Statements This press release contains forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the completion expected proceeds and anticipated use of proceeds of the Private Placement; the anticipated cash runway of the Company; and future expectations, plans, and prospects of the Company. Words such as 'anticipates,' 'believes,' 'expects,' 'intends,' 'projects,' and 'future' or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the proposed securities offering discussed above will be consummated on the terms described or at all. Completion of the proposed Private Placement and the terms thereof are subject to numerous factors, many of which are beyond the control of the Company, including, without limitation, market conditions, failure of customary closing conditions and the risk factors and other matters set forth in the filings the Company makes with the AMF from time to time. The Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law. View source version on CONTACT: GenSight Biologics Chief Financial Officer Jan Eryk Umiastowski [email protected] KEYWORD: FRANCE EUROPE INDUSTRY KEYWORD: HEALTH NEUROLOGY GENETICS CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY SOURCE: GenSight Biologics Copyright Business Wire 2025. PUB: 07/08/2025 02:11 PM/DISC: 07/08/2025 02:11 PM
Business Wire
08-07-2025
- Business
- Business Wire
GenSight Biologics Reports Cash Position as of June 30, 2025
PARIS--(BUSINESS WIRE)--Regulatory News: "The second quarter of 2025 marked a period of significant operational progress for GenSight Biologics." Share GenSight Biologics (" GenSight Biologics" or the " Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its cash position as of June 30, 2025. "The second quarter of 2025 marked a period of significant operational progress for GenSight Biologics. We successfully completed the technology transfer of LUMEVOQ's upstream manufacturing process to our new partner Catalent, secured the ANSM's agreement to consider opening the AAC program in France, and closed our private placement financing in July, ' commented Jan Eryk Umiastowski, CFO of GenSight Biologics. ' We continue to actively pursue non-dilutive financing options to support our critical value-driving activities. With the AAC program launch planned for Q4 2025, we have established a clear financial pathway through H2 2026, when we expect to initiate our Phase III RECOVER trial and submit our marketing application to the MHRA of the UK." Cash position as of June 30, 2025 GenSight Biologics' cash and cash equivalents totaled €0.3 million as of June 30, 2025, compared to €0.9 million as of March 31, 2025. With the equity-with-warrants-attached and pre-funded warrants financing announced on July 1, 2025 (approximately €3.9 million) and the anticipated collection of approximately additional €0.2 million in Research Tax Credit (CIR) in September, and based on current operations, plans, and assumptions, this balance should fund operations until early October 2025. EUR 0.7 million of the proceeds from the financing has been used for the repayment in principal on the convertible bonds held by Heights Capital through offset against their subscription. The funds are insufficient to cover operational requirements for the next 12 months. However, the anticipated opening of the AAC program in France in Q4 2025 (targeted for October) will establish a clear cash pathway until H2 2026, when the company expects to initiate the RECOVER Phase III clinical trial and to submit the UK MHRA marketing application for LUMEVOQ ®. The company is pursuing strategic options that could generate funds for the Phase III trial and UK regulatory submission. These include: Licensing of LUMEVOQ outside Europe and the United States Exploring paid compassionate access programs in other countries Release of the second tranche of the EIB loan In the first quarter of 2026, the company will have a precise view of residual financing needs and will make a strategic decision on additional financing modalities. If necessary, GenSight Biologics may access financial markets. Options in the medium term include partnering or M&A arrangements. Recapitulation of Recent Milestones Regulatory Progress and Named Early Access Program (AAC) In June 2025, GenSight achieved a significant regulatory milestone when the ANSM agreed to consider opening the LUMEVOQ ® AAC program, contingent upon approval of a dose-ranging study. The Company has submitted a preliminary study design to the agency and expects to finalize the protocol in Q3 2025. Concurrently, GenSight is working with the ANSM to establish AAC program access for patients who may not qualify for the study but could benefit from early access to LUMEVOQ ®. The AAC program is targeted to launch by Q4 2025, with an anticipated opening in October 2025. Manufacturing Partnership and Scale-Up In June 2025, the Company successfully completed the transfer of LUMEVOQ ® 's upstream manufacturing process to its new manufacturing partner, Catalent, Inc. The technology transfer is expected to be finalized by the end of 2025, positioning Catalent to manufacture the drug product for both the planned global Phase III RECOVER trial and regulatory submission requirements. Number of outstanding shares As of July 8, 2025, GenSight Biologics' number of outstanding shares was 152,717,762 ordinary shares. Financial Agenda The Company will report its interim H1 financial results by the end of September 2025. About GenSight Biologics S.A. GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics' pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. Forward-Looking Statements This press release contains forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the completion expected proceeds and anticipated use of proceeds of the Private Placement; the anticipated cash runway of the Company; and future expectations, plans, and prospects of the Company. Words such as 'anticipates,' 'believes,' 'expects,' 'intends,' 'projects,' and 'future' or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the proposed securities offering discussed above will be consummated on the terms described or at all. Completion of the proposed Private Placement and the terms thereof are subject to numerous factors, many of which are beyond the control of the Company, including, without limitation, market conditions, failure of customary closing conditions and the risk factors and other matters set forth in the filings the Company makes with the AMF from time to time. The Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law.
Yahoo
12-06-2025
- Business
- Yahoo
GenSight Biologics Reaches Agreement with ANSM for Opening of LUMEVOQ® Named Early Access Program (AAC) in France
Agreement to consider opening the French Early Access Program expeditiously after approval of a dose-ranging study Design for dose-ranging study submitted, with clinical trial application targeted for Q3 2025 Opening of AAC targeted for Q4 2025 at the latest Multiple near-term value catalysts expected over next 12 months PARIS, June 12, 2025--(BUSINESS WIRE)--Regulatory News: GenSight Biologics ("GenSight Biologics" or the "Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that it has reached agreement with the French medicines safety agency ANSM to consider expeditiously opening the French named early access program (AAC) for LUMEVOQ® upon approval of a dose-ranging clinical study. Clear Path Forward for LUMEVOQ® AAC Program in France Following extensive discussions, GenSight reached alignment with ANSM on a plan to open the LUMEVOQ® AAC program. The agency has agreed that the authorization of a focused dose-ranging study could enable the opening of the early access program. The Company has submitted a preliminary design of the study to the agency and aims to finalize the protocol of a dose-ranging study in Q3 2025. In parallel, the Company will work with the agency to find a solution for patients who may not be included in the study but who may benefit from the AAC program. The AAC program is targeted to open in Q4 2025 at the latest. "In the interest of clearing the way for patients to be treated with LUMEVOQ, we are pleased to have achieved this important agreement with ANSM on a clear path forward for opening patient access to LUMEVOQ in France" said Laurence Rodriguez, Chief Executive Officer of GenSight Biologics. "We are thankful for the ANSM's ongoing engagement and openness to discussion, as we work towards the shared goal of providing access to LHON patients who urgently need a safe and effective treatment." Financing Strategy to Support Regulatory Milestones GenSight is implementing a financing strategy to bridge operations through the opening of the AAC program and prepare for the new global Phase III clinical trial. The Company is actively pursuing various funding initiatives to support these critical regulatory milestones. "We are working on our financing strategy to manage the bridge between now and the opening of the AAC program and the initiation of the Phase III study," commented Jan Eryk Umiastowski, CFO of GenSight Biologics. "Our focus remains on securing the resources needed to execute our regulatory strategy while exploring additional funding opportunities. " Advancing Core Marketing Authorization Strategy In parallel with the French AAC program developments, GenSight will continue to advance its global marketing authorization strategy: Preparation for regulatory consultations in the US and EU Planning for the global Phase III trial scheduled to begin in 2026, designed to meet FDA and EMA requirements Completing the transition to a new manufacturing partner to secure reliable clinical and commercial supply Advancing preparations for MHRA submission in the United Kingdom During this period, the Company will actively pursue additional non-dilutive funding opportunities, including licensing arrangements outside North America and Europe and potential M&A activities. Multiple Value Catalysts GenSight anticipates a number of significant value-creating events in 2025-2026: Q3 2025: Clinical trial application for focused dose-ranging study Q4 2025: Completion of manufacturing tech transfer Q4 2025: Opening of the AAC program Q2 2026: Completion of Phase III trial preparations Early H2 2026: Initiation of global Phase III clinical trial Early H2 2026: pre-submission meeting with MHRA Financial Position The Company received €0.7 million of its Research Tax Credit (CIR) end of May, with the remaining €0.4 million to be paid in July 2025. Based on current operations and projections, GenSight's cash will support operations until mid-July 2025. The Company acknowledges that current funds are insufficient to cover operational requirements for the next 12 months. The planned financing initiatives are designed to extend the cash runway and enable the initiation of the Phase III clinical trial and UK MHRA marketing application for LUMEVOQ®. As of June 12, 2025, the number of outstanding GenSight Biologics shares was 131,466,495 ordinary shares. Risk factors Detailed information regarding the Company, including its business, financial information, results, perspectives and related risk factors are contained (i) in the Company's 2024 Universal Registration Document filed with the AMF on April 8, 2025 under number D.25-0234. This document, as well as other regulated information and all of the Company's press releases, can be accessed on the Company's website ( and/or AMF ( The reader's attention is drawn to the risk factors related to the Company and its activities presented in chapter 3 of its 2024 URD in particular the liquidity risk presented in the chapter 3.1.1. About GenSight Biologics GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics' pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding product development prospects and financial projections. These statements do not constitute guarantees of future performance and involve risks and uncertainties. While the Company is actively pursuing financing solutions, regulatory requirements necessitate disclosure that material uncertainty exists regarding the Company's ability to continue as a going concern if sufficient funding cannot be secured. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in GenSight Biologics' regulatory filings with the French Autorité des Marchés Financiers. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, GenSight Biologics undertakes no obligation to update or revise the information contained in this press release. View source version on Contacts GenSight Biologics Chief Financial Officer Jan Eryk Umiastowski jeumiastowski@
Business Wire
12-06-2025
- Business
- Business Wire
GenSight Biologics Reaches Agreement with ANSM for Opening of LUMEVOQ ® Named Early Access Program (AAC) in France
PARIS--(BUSINESS WIRE)--Regulatory News: GenSight Biologics ("GenSight Biologics" or the "Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that it has reached agreement with the French medicines safety agency ANSM to consider expeditiously opening the French named early access program (AAC) for LUMEVOQ ® upon approval of a dose-ranging clinical study. Clear Path Forward for LUMEVOQ ® AAC Program in France Following extensive discussions, GenSight reached alignment with ANSM on a plan to open the LUMEVOQ ® AAC program. The agency has agreed that the authorization of a focused dose-ranging study could enable the opening of the early access program. The Company has submitted a preliminary design of the study to the agency and aims to finalize the protocol of a dose-ranging study in Q3 2025. In parallel, the Company will work with the agency to find a solution for patients who may not be included in the study but who may benefit from the AAC program. The AAC program is targeted to open in Q4 2025 at the latest. "In the interest of clearing the way for patients to be treated with LUMEVOQ, we are pleased to have achieved this important agreement with ANSM on a clear path forward for opening patient access to LUMEVOQ in France" said Laurence Rodriguez, Chief Executive Officer of GenSight Biologics."We are thankful for the ANSM's ongoing engagement and openness to discussion, as we work towards the shared goal of providing access to LHON patients who urgently need a safe and effective treatment." Financing Strategy to Support Regulatory Milestones GenSight is implementing a financing strategy to bridge operations through the opening of the AAC program and prepare for the new global Phase III clinical trial. The Company is actively pursuing various funding initiatives to support these critical regulatory milestones. ' We are working on our financing strategy to manage the bridge between now and the opening of the AAC program and the initiation of the Phase III study,' commented Jan Eryk Umiastowski, CFO of GenSight Biologics. "Our focus remains on securing the resources needed to execute our regulatory strategy while exploring additional funding opportunities." Advancing Core Marketing Authorization Strategy In parallel with the French AAC program developments, GenSight will continue to advance its global marketing authorization strategy: Preparation for regulatory consultations in the US and EU Planning for the global Phase III trial scheduled to begin in 2026, designed to meet FDA and EMA requirements Completing the transition to a new manufacturing partner to secure reliable clinical and commercial supply Advancing preparations for MHRA submission in the United Kingdom During this period, the Company will actively pursue additional non-dilutive funding opportunities, including licensing arrangements outside North America and Europe and potential M&A activities. Multiple Value Catalysts GenSight anticipates a number of significant value-creating events in 2025-2026: Financial Position The Company received €0.7 million of its Research Tax Credit (CIR) end of May, with the remaining €0.4 million to be paid in July 2025. Based on current operations and projections, GenSight's cash will support operations until mid-July 2025. The Company acknowledges that current funds are insufficient to cover operational requirements for the next 12 months. The planned financing initiatives are designed to extend the cash runway and enable the initiation of the Phase III clinical trial and UK MHRA marketing application for LUMEVOQ ®. As of June 12, 2025, the number of outstanding GenSight Biologics shares was 131,466,495 ordinary shares. Risk factors Detailed information regarding the Company, including its business, financial information, results, perspectives and related risk factors are contained (i) in the Company's 2024 Universal Registration Document filed with the AMF on April 8, 2025 under number D.25-0234. This document, as well as other regulated information and all of the Company's press releases, can be accessed on the Company's website ( and/or AMF ( The reader's attention is drawn to the risk factors related to the Company and its activities presented in chapter 3 of its 2024 URD in particular the liquidity risk presented in the chapter 3.1.1. About GenSight Biologics GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics' pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding product development prospects and financial projections. These statements do not constitute guarantees of future performance and involve risks and uncertainties. While the Company is actively pursuing financing solutions, regulatory requirements necessitate disclosure that material uncertainty exists regarding the Company's ability to continue as a going concern if sufficient funding cannot be secured. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in GenSight Biologics' regulatory filings with the French Autorité des Marchés Financiers. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, GenSight Biologics undertakes no obligation to update or revise the information contained in this press release.
