GenSight Biologics Reports Cash Position as of June 30, 2025
"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.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Time Business News
13 hours ago
- Time Business News
Sales Audits: Ensuring Ongoing UK Vape Compliance
In the United Kingdom's vape industry, compliance is not a one-time checkpoint—it is a continuous obligation. Sales audits have emerged as a vital mechanism to ensure that vape businesses remain aligned with complex and evolving regulatory frameworks. From age-verification protocols to product packaging requirements, UK retailers and wholesalers must demonstrate diligence at every transaction point. A comprehensive audit process identifies risks, reinforces accountability, and builds a compliant infrastructure that can withstand both routine scrutiny and legislative change. For retailers aiming to stay ahead in the competitive vape market, securing large quantities of stock at discounted rates is a smart move. This approach ensures consistent availability for customers while maximizing profit margins. Among the most effective strategies is to bulk buy vapes, which not only reduces per-unit cost but also simplifies inventory management. With consumer demand constantly evolving, having a diverse selection readily available strengthens customer loyalty. Additionally, bulk purchasing allows for better forecasting and promotional planning, giving retailers the flexibility to respond to trends swiftly. In today's fast-paced retail environment, smart stock strategies are essential. Sales audits are structured evaluations of a business's sales operations, focusing specifically on adherence to legal and internal standards. In the UK vape sector, they typically assess: Age verification processes Product tracking and traceability Sales records and VAT reporting Accuracy of product labelling and nicotine content declarations Promotional practices within legal bounds Unlike financial audits, which are retrospective, sales audits are often proactive and preventative. They aim to identify compliance gaps before they result in penalties, suspensions, or reputational damage. UK vape regulations are governed primarily by the Tobacco and Related Products Regulations 2016 (TRPR) and enforced by agencies such as Trading Standards and the Medicines and Healthcare products Regulatory Agency (MHRA). A sales audit will verify that: Only MHRA-notified vape products are being sold Packaging includes all required warnings, nicotine limits, and ingredient disclosures No product exceeds the 2ml e-liquid tank capacity or 20mg/ml nicotine strength limit Retailers implement and document a Challenge 25 policy Promotional materials comply with advertising restrictions, particularly around youth appeal Failure in any of these areas could result in heavy fines, confiscation of inventory, or criminal liability—making audits essential for risk mitigation. Effective sales audits rely on thorough record-keeping. Vape retailers must be able to produce documentation proving that: Staff have been trained in compliance protocols Age verification systems (in-person or digital) are consistently applied Sales data is accurately captured through POS and CRM systems Supplier invoices correspond with MHRA-compliant product codes Maintaining detailed and accessible logs allows businesses to respond confidently to inspections and verify their adherence to regulation. Inadequate records often suggest deeper operational negligence. Sales audits also focus on employee awareness. Even the most well-intentioned business can fall out of compliance if frontline staff aren't trained to enforce protocols. Audit teams may assess: Knowledge of nicotine limits and product categories Familiarity with ID checking procedures Understanding of the penalties for non-compliance Providing ongoing training and conducting internal mystery shopper exercises strengthens audit results and embeds a culture of responsibility throughout the team. For e-commerce vape retailers in the UK, audits extend beyond the physical point of sale. Online compliance includes: Age verification systems compliant with PAS 1296 standards Legally compliant product imagery and descriptions SSL encryption and secure checkout processes Transparent terms of service and refund policies An online vape business must show that it prevents underage access just as stringently as a brick-and-mortar shop. Sales audits for digital operations may also inspect delivery partner policies to ensure age checks are enforced upon delivery. As compliance demands intensify, many vape businesses now partner with external auditing firms or legal consultants to conduct annual or bi-annual sales audits. These third parties bring unbiased scrutiny and stay up-to-date with emerging regulatory changes. External audits can provide: Comprehensive checklists tailored to vape regulations Gap analysis with clear corrective action plans Documentation to support defence in the event of enforcement action Such services also help businesses prepare for unannounced inspections from Trading Standards or MHRA officials. Modern vape retailers can streamline audits using tech tools that track and report compliance data in real time. Integrated POS systems log age verification attempts, sales records, and SKU performance, while CRM platforms document customer engagement and marketing consent. Audit-specific software can automate reporting, flag anomalies, and generate compliance dashboards. These digital systems reduce human error and enable fast response when discrepancies are detected. An audit is only as valuable as the corrective actions it inspires. Once issues are identified—be it mislabelled stock, lapses in age verification, or undocumented procedures—businesses must act swiftly. Establishing a formal process for implementing audit recommendations, retraining staff, and updating SOPs ensures ongoing compliance. It also demonstrates good faith in the eyes of regulators, potentially mitigating penalties in case of future violations. As the vaping industry evolves, businesses across the UK are recognizing the advantages of scaling through bulk purchasing. Retailers and distributors are tapping into broader product ranges, ensuring they meet customer demand with competitive pricing and quick restocks. In particular, vape wholesale UK continues to gain momentum as more shops shift from small orders to large-scale inventory solutions. This approach helps improve profit margins while staying ahead in a competitive market. With access to new brands, trending flavours, and exclusive deals, wholesalers are becoming the backbone of retail success in the vaping sector across the United Kingdom. Sales audits are indispensable for ensuring ongoing compliance in the UK vape industry. With tight regulations and increasing public scrutiny, businesses cannot afford to be reactive. Regular internal and external audits not only protect against fines and shutdowns but also reinforce operational integrity. In a sector where legal precision is as crucial as product quality, audits are not just due diligence—they are strategic safeguards for sustainable success. TIME BUSINESS NEWS
Associated Press
a day ago
- 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
a day ago
- 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.
