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Associated Press
2 days ago
- 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
2 days ago
- 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.
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@
