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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.
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First Post
08-07-2025
- Politics
- First Post
Israeli military's use of Palestinians as human shields in Gaza is systematic, says Osint report
Open source intelligence based on video clips posted online adds weight to previous reports that the Israeli military is systematically using Palestinians as human shields in Gaza and West Bank read more Israeli military has been found to systematically use Palestinians as human shields in Gaza and West Bank. AI-generated image via DALL-E A growing body of visual evidence from both Gaza and the West Bank shows Palestinian civilians being used as human shields during ongoing Israeli military operations, finds an open source intelligence (Osint) report. It has cited multiple videos circulating online, showing blindfolded and restrained individuals, who are placed in close proximity to soldiers, or even tied to the front of military vehicles during active missions. The clips, which span several locations across Palestinian territories under Israeli control, depict a troubling consistency: unarmed individuals are bound, hooded, or made to wear military-style vests while positioned at the forefront of advancing units, the report says. STORY CONTINUES BELOW THIS AD These images have sparked outrage on social media, with many describing them as a flagrant violation of the laws of war. The Centre for Information Resilience (CIR), an independent investigative group, has confirmed the authenticity of several of these videos. CIR's open-source intelligence (Osint) team employed geolocation, drone footage analysis, and cross-platform video comparisons to confirm where and when these incidents occurred. Shocking documentation obtained by [@AJENews] originating from an Israeli drone showing the use of a Palestinian civilian as a human shield in Shujjaia Neighborhood, East Gaza city last December to search after militants, the man is being monitored by drones the whole time — Younis Tirawi | يونس (@ytirawi) May 2, 2024 Patterns across territories One clip shows a man strapped to the bonnet of an armoured vehicle as it drives through a residential street. Another features several bound men flanked by soldiers, some of whom appear to be directing or shielding fire. In a separate sequence, drone footage captures a blindfolded man in a combat zone while Israeli troops take cover behind him. Stills taken from footage posted on 22 June 2024 show an individual being driven on the bonnet of an Israeli military vehicle. Image courtesy: CIR One particularly graphic video clip showed a stripped, injured man with his hands bound behind his back man with at least six armed IDF soldiers standing beside an armoured vehicle. STORY CONTINUES BELOW THIS AD The man had red circular lesions throughout his body, including on his neck, torso, and right thigh, which were assessed as consistent with wounds caused by airsoft and pellet guns. READ MORE: Body as battlefield: How Israel and Hamas top brass 'authorised' use of rape, sexual violence The detained individual is seen entering a damaged residential building and is followed up a stairwell by a soldier holding a flashlight. In each of these cases, CIR was able to match specific architectural features, road layouts, and environmental conditions to verify the location. This mapping confirmed that the events occurred not only in Gaza, but also in areas of the West Bank such as Jenin and Nablus, pointing to a broader operational trend rather than isolated misconduct. Digital verification and online traces CIR's analysts relied on real-time social media posts, often made within minutes or hours of the actual incidents. Metadata, shadow analysis, and satellite imagery were used to corroborate these posts. The circulation of these videos on platforms like X (formerly Twitter) provided both a distribution channel and a timestamped archive for investigators to assess. CIR's findings add weight to previous reports, including one by _The Associated Press_ that presented accounts of seven Palestinians who had been used as human shields to make sure areas were clear of bombs and gunmen. STORY CONTINUES BELOW THIS AD Under international humanitarian law, particularly the Fourth Geneva Convention, the use of human shields is explicitly prohibited and considered a war crime. As fighting continues and civilian protections appear increasingly eroded, these visuals, combined with geospatial data, provide a chilling look into the tactics employed on the ground. (With inputs from agencies)
Express Tribune
21-06-2025
- Business
- Express Tribune
FBR clarifies concerns over tax law amendments
As the Finance Bill 2025 undergoes debate in the National Assembly and within business circles, concerns have emerged regarding certain proposed amendments to tax laws. Several reports in the digital and print media suggest a lack of clarity and public understanding surrounding some key provisions. A particular point of contention involves the proposed changes to arrest powers under tax fraud investigations. Currently, Section 37A of the Sales Tax Act, 1990 provides legal grounds for arrest in such cases, along with safeguards, such as immediate intimation to a Special Judge and mandatory court appearance within 24 hours. The proposed amendment, however, introduces stricter procedural checks. It requires a prior inquiry and written approval from the Commissioner Inland Revenue (CIR) before any investigation is initiated. Only after the CIR's authorisation can an investigation officer — vested with the powers of an officer in charge under the Code of Criminal Procedure, 1898 — proceed with an arrest. Even then, the officer must have reasonable grounds to believe that tax fraud has occurred. If an arrest is found to be mala fide, the case will be referred to the Chief Commissioner for a fact-finding inquiry. These new provisions mark a shift from the previous framework, where an Assistant CIR could authorise arrests. The amendments are being positioned as a move towards greater transparency and procedural fairness. In a recent press statement, the Federal Board of Revenue (FBR) has maintained that these measures aim to strike a balance — reassuring compliant taxpayers while ensuring that tax evaders face strict legal consequences.
Business Recorder
21-06-2025
- Business
- Business Recorder
Arrests for tax fraud: major changes made in sales tax law thru Finance Bill
ISLAMABAD: The Federal Board of Revenue (FBR) has introduced major changes in sales tax law through Finance Bill 2025 for the arrest of those involved in tax evasion or tax fraud. According to a statement issued by the FBR on Friday, Finance bill is currently being discussed in the National Assembly and among various business circles. An impression has been created that some of the amendments introduced in the Finance Bill are not understood well by the public at large. Arrest for tax fraud: Senate panel for defining a threshold For instance, the legal provisions for the arrest of those involved in a tax fraud have already been provided under Section 37A of the Sales Tax Act, 1990 along with an elaborate procedure to be followed after the arrest which involves intimating the Special Judge immediately and the production of such person before Special Judge within 24 hours. However, the proposed amendment now restricts the powers of the officer to arrest by making prior inquiry after approval of the Commissioner Inland Revenue (CIR). Only on the basis of the findings of the inquiry CIR will authorise the investigation which would give the investigation officer the powers of an officer in charge of a police station under Code of Criminal Procedure, 1898 (Act V of 1898). The arrest can only be made with the prior approval of CIR if the investigation officer has reasons to believe that a tax fraud may have been committed by a person. The FBR further stated that the new legal provision further provides that if the arrest is malafide, the matter will be referred to the Chief Commissioner for fact finding inquiry. This shows that in contrast to the earlier provision where an Assistant CIR could arrest an offender, the new provisions bring transparency in the process by a mandatory prior inquiry and investigation and finally permission by the CIR. Moreover, certain changes and amendments are also necessary to reassure the compliant taxpayers that those evading taxes or involved in tax fraud are dealt with by the state with an iron hand. FBR Chairman Rashid Mahmood Langrial has expressed his willingness to discuss the recent changes made in the tax laws and introduce changes wherever needed, for example, the provisions related to arrest could be revised to mandate the permission of multiple senior officers before any arrest. Furthermore, in order to ensure that these powers are not misused by the authorised tax officers against the compliant taxpayers and business community, Prime Minister Shehbaz Sharif has formed a high-powered committee, which will be headed by Minister for Finance and Revenue, to re-evaluate the proposed amendments and suggest adequate safeguards to prevent potential misuse of powers. The other members of the Committee will include Ministers of Law and Economic Affairs Division, Minister of State for Finance, SAPM Industries and Chairman FBR. The Committee will also examine various options to ensure that legal economic activities are not stifled and propose additional protective measures against unlawful use of authority. The Committee will submit its recommendations to Prime Minister in three days. FBR is committed to safeguard the legal rights of the compliant taxpayers and to increase the tax collection and state revenues by discouraging non-compliant taxpayers and acknowledging those who are paying their due share to the state, FBR added. Copyright Business Recorder, 2025
Business Recorder
21-06-2025
- Business
- Business Recorder
Arrests for tax fraud: Major changes made in ST law thru finance bill
ISLAMABAD: The Federal Board of Revenue (FBR) has introduced major changes in sales tax law through Finance Bill (2025-26) for the arrest of those involved in tax evasion or tax fraud. According to a statement issued by the FBR on Friday, Finance bill is currently being discussed in the National Assembly and among various business circles. An impression has been created that some of the amendments introduced in the finance bill are not understood well by the public at large. Arrest for tax fraud: Senate panel for defining a threshold For instance, the legal provisions for the arrest of those involved in a tax fraud have already been provided under Section 37A of the Sales Tax Act, 1990 along with an elaborate procedure to be followed after the arrest which involves intimating the Special Judge immediately and the production of such person before Special Judge within 24 hours. However, the proposed amendment now restricts the powers of the officer to arrest by making prior inquiry after approval of the Commissioner Inland Revenue (CIR). Only on the basis of the findings of the inquiry CIR will authorise the investigation which would give the investigation officer the powers of an officer in charge of a police station under Code of Criminal Procedure, 1898 (Act V of 1898). The arrest can only be made with the prior approval of CIR if the investigation officer has reasons to believe that a tax fraud may have been committed by a person. The FBR further stated that the new legal provision further provides that if the arrest is malafide, the matter will be referred to the Chief Commissioner for fact finding inquiry. This shows that in contrast to the earlier provision where an Assistant CIR could arrest an offender, the new provisions bring transparency in the process by a mandatory prior inquiry and investigation and finally permission by the CIR. Moreover, certain changes and amendments are also necessary to reassure the compliant taxpayers that those evading taxes or involved in tax fraud are dealt with by the state with an iron hand. FBR Chairman Rashid Mahmood Langrial has expressed his willingness to discuss the recent changes made in the tax laws and introduce changes wherever needed, for example, the provisions related to arrest could be revised to mandate the permission of multiple senior officers before any arrest. Furthermore, in order to ensure that these powers are not misused by the authorised tax officers against the compliant taxpayers and business community, Prime Minister Shehbaz Sharif has formed a high-powered committee, which will be headed by Minister for Finance and Revenue, to re-evaluate the proposed amendments and suggest adequate safeguards to prevent potential misuse of powers. The other members of the Committee will include Ministers of Law and Economic Affairs Division, Minister of State for Finance, SAPM Industries and Chairman FBR. The Committee will also examine various options to ensure that legal economic activities are not stifled and propose additional protective measures against unlawful use of authority. The Committee will submit its recommendations to Prime Minister in three days. FBR is committed to safeguard the legal rights of the compliant taxpayers and to increase the tax collection and state revenues by discouraging non-compliant taxpayers and acknowledging those who are paying their due share to the state, FBR added. Copyright Business Recorder, 2025
