This is an observational study to compare the utility of the novel aMRI approach in human brain to the standard of care imaging approach for diagnosing and assessing glioma. Tumor cells have altered metabolism compared to normal cells.This makes metabolic activity imaging useful for diagnosing and assessing neurological disease. However, current options for metabolic activity imaging are limited. Metabolic activity imaging is primarily conducted using positron emission tomography (PET) with a radioactive tracer called fludeoxyglucose F-18 (¹⁸FDG). A PET scan is a procedure in which a small amount of radioactive glucose (¹⁸FDG) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. PET imaging is very expensive and is usually much less available than other imaging techniques such as magnetic resonance imaging (MRI). MRI uses radiofrequency waves and a strong magnetic field to provide clear and detailed pictures of internal organs and tissues. While MRI is more available than PET, it isn't as useful in evaluating metabolic activity. Unlike standard MRI, the aMRI approach uses new ways of analyzing MRI images that provides information about tumor cell metabolic activity. Via direct comparison with a standard metabolic imaging approach, ¹⁸FDG PET, this clinical trial will assess the validity of aMRI as a metabolic imaging approach for evaluating neurological disease in patients with glioma.

Start Date11 Dec 2023

Sponsor / Collaborator

OHSU Knight Cancer Institute

[+1]

NCT05915702 / CompletedPhase 3

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Start Date24 Jul 2023

Sponsor / Collaborator

Bayer AG

NCT05915728 / CompletedPhase 3

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Start Date24 Jul 2023

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Gadoterate Meglumine

100 Translational Medicine associated with Gadoterate Meglumine

100 Patents (Medical) associated with Gadoterate Meglumine

781

Literatures (Medical) associated with Gadoterate Meglumine

01 Apr 2024·Magnetic resonance imaging

NSF evaluation of gadolinium biodistribution in renally impaired rats: Using novel metabolic Gd2O3 nanoparticles coated with β-cyclodextrin (Gd2O3@PCD) in MR molecular imaging

Article

Author: Haghgoo, Soheila ; Khoobi, Mehdi ; Riyahi Alam, Nader ; Ashouri, Hanieh ; Gholami, Mahdi ; Rasouli, Zahra

The use of conventional gadolinium(Gd)-based contrast agents in magnetic resonance imaging (MRI) poses a significant risk of Nephrogenic Systemic Fibrosis (NSF) syndrome in patients with impaired renal function (grades 4 and 5). To address this issue, a new study has introduced a novel metabolic Gadolinium oxide nanoparticle (Gd2O3 NPs) coated with β-cyclodextrin (βCD). The study aims to investigate NSF syndrome by quantifying tissue Gd deposition biodistribution in renal impairment rats using MR molecular imaging. This is the first study of its kind to use this approach. A group of 20 rats were divided into four groups, each containing five rats that underwent 5/6 nephrectomy. The rats received 12 intravenous injections of a novel homemade synthesized gadolinium oxide polycyclodextrin (Gd2O3@PCD) at a dose of 0.1 mmol/kg, conventional contrast agents (CAs) drugs of Omniscan (Gd-DTPA-BMA) and Dotarem (Gd-DOTA), at a dose of 2.5 mmol/kg, and 250 μl saline for two injections per week during six weeks. T1-weighted MR imaging was performed before the injections and once a week for six weeks to quantify Gd deposition in four different organs (skin, liver, heart, and lung) in rats using inductively coupled plasma mass spectrometry (ICP-MS). The relationship between Signal-to-Noise Ratio (SNR) and biodistribution of Gd deposition due to NSF-induced syndrome was also calculated. The results of the study showed that the Gd concentrations in tissues were significantly higher in the Gd2O3@PCD group compared to the other groups, without any significant histopathological changes (P < 0.05). In the Gd2O3@PCD group, Gd was mainly deposited in the skin, followed by the liver, lung, and heart, without any symptoms of thickening or hardening of the skin. The Gd concentrations in the skin, liver, lung, and heart were significantly lower in the Dotarem group than in the Omniscan group (P < 0.05). In the histopathological examinations, the Omniscan group showed increased cellularity in the dermis. A significant hyperintensity was observed in the Gd2O3@PCD-treated rats compared to the Dotarem and Omniscan groups in the liver, heart, and lung. Compared to conventional Gd-based CAs, the novel metabolically Gd2O3@PCD with increased SNR, biosafety, and a considerably lower probability of developing NSF, has potential applicability for diagnosing patients with renal diseases in clinical MR Molecular Imaging (MRMI).

01 Jan 2024·Radiology

Gadolinium Presence in Rat Skin: Assessment of Histopathologic Changes Associated with Small Fiber Neuropathy

Article

Author: Balzer, Thomas ; Treu, Axel ; Ulbrich, Hannes-Friedrich ; Neddens, Joerg ; Thuss, Uwe ; Lohrke, Jessica ; Frenzel, Thomas ; Pietsch, Hubertus ; Prokesch, Manuela ; Boyken, Janina ; Jost, Gregor

Background The presence of gadolinium traces in the skin after administration of gadolinium-based contrast agents (GBCAs) raised safety concerns regarding a potential association with small fiber neuropathy (SFN). Purpose To investigate signs of SFN in rat foot pads by quantification of the intraepidermal nerve fiber density (IENFD) after multiple GBCA administrations and to evaluate gadolinium concentration, chemical species, and clearance. Materials and Methods Fifty rats received eight intravenous injections of either gadodiamide, gadobutrol, gadoterate, gadoteridol (8 × 0.6 mmol per kilogram of body weight), or saline (1.2 mL per kilogram of body weight), within 2 weeks and were sacrificed 5 days or 5 weeks after the last injection. IENFD was determined with protein gene product (PGP) 9.5 immunofluorescent staining and blinded and automated image analysis. The gadolinium and GBCA concentrations were measured with inductively coupled plasma mass spectrometry (ICP-MS), laser ablation ICP-MS, and matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI MSI). P values were calculated using linear contrasts of model analysis. Results The IENFD (measured as geometric mean [SD] and in number of nerve fibers per millimeter of epidermis) was not significantly altered after 5 days (saline, 8.4 [1.1]; gadobutrol, 9.7 [1.2]; gadoterate, 9.2 [1.2]; gadoteridol, 9.9 [1.3]; gadodiamide, 10.5 [1.2]) or 5 weeks (saline, 19.7 [1.4]; gadobutrol, 16.4 [1.6]; gadoterate, 14.3 [1.6]; gadoteridol, 22.2 [1.8]; gadodiamide, 17.9 [1.4]). Gadolinium skin concentrations were highest for gadodiamide after 5 days (16.0 nmol/g [1.1]) and 5 weeks (10.6 nmol/g [1.2], -33%). Macrocyclic agents were lower at 5 days (gadoteridol, 2.6 nmol/g [1.2]; gadobutrol, 2.7 nmol/g [1.1]; and gadoterate, 2.3 nmol/g [1.2]) and efficiently cleared after 5 weeks (gadoteridol, -95%; gadobutrol and gadoterate, -96%). The distribution of gadolinium and IENF did not visually overlap. For macrocyclic agents, gadolinium was found in sweat glands and confirmed to be intact chelate. Conclusion There were no signs of SFN in rat foot pads using multiple dosing regimens at two time points after administration of GBCAs. Macrocyclic GBCAs exhibited lower levels of gadolinium in the skin and were effectively eliminated within 5 weeks compared with linear gadodiamide, and intact macrocyclic GBCA was detected in sweat glands. © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Clement in this issue.

01 Feb 2024·Journal of bioscience and bioengineering

Preparation and performance of biocompatible gadolinium polymer as liver-targeting magnetic resonance imaging contrast agent

Article

Author: Zheng, Yan ; Li, Xiaojing ; Wan, Chuanling ; Zhan, Youyang ; Hu, Tingting

A biocompatible macromolecule-conjugated gadolinium chelate complex (PAV₂-EDA-DOTA-Gd) as a new liver-specific contrast agent for magnetic resonance imaging (MRI) was synthesized and evaluated. An aspartic acid-valine copolymer was used as a carrier and ethylenediamine as a chemical linker, and the aspartic acid-valine copolymer was covalently linked to the small molecule MRI contrast agent Gd-DOTA (Dotarem) to synthesize a large molecule contrast agent. In vitro MR relaxation showed that the T₁-relaxivity of PAV₂-EDA-DOTA-Gd (13.7 mmol^-1 L s^-1) was much higher than that of the small-molecule Gd-DOTA (4.9 mmol^-1 L s^-1). In vivo imaging of rats showed that the enhancement effect of PAV₂-EDA-DOTA-Gd (55.37 ± 2.80%) on liver imaging was 2.6 times that of Gd-DOTA (21.12 ± 3.86%), and it produced a longer imaging window time (40-70 min for PAV₂-EDA-DOTA-Gd and 10-30 min for Gd-DOTA). Preliminary safety experiments, such as cell experiments and tissue sectioning, showed that PAV₂-EDA-DOTA-Gd had low toxicity and satisfactory biocompatibility. The results of this study indicated that PAV₂-EDA-DOTA-Gd had high potential as a liver-specific MRI contrast agent.

News (Medical) associated with Gadoterate Meglumine

11 Jun 2024

·www.globenewswire.com

Monopar and NorthStar Amend & Extend Collaboration

Highlights: Builds on Companies’ respective core strengthsAligns intellectual property rightsEstablishes a long-term supply agreement under which NorthStar provides actinium-225 for Monopar’s development and potential future commercial programs WILMETTE, Ill. and Beloit, Wis., June 11, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company, and NorthStar Medical Radioisotopes, LLC, a global innovator in development and commercial production of medical radioisotopes, today announced an amendment and expansion to their existing collaboration. Under terms of the revised collaboration, the Companies entered into a long-term, non-exclusive master supply agreement for NorthStar to provide Monopar with the powerful therapeutic radioisotope actinium-225 (Ac-225). The amendment builds on NorthStar’s significant investment in Ac-225 manufacturing and Monopar’s promising preclinical therapeutic results with Ac-225 in its lead MNPR-101 radiopharma program. The amendment also clarifies certain economic terms and those related to jointly developed intellectual property rights for Monopar’s MNPR-101 for radiopharmaceutical use. Monopar has acquired those rights from NorthStar, together with certain broad, jointly developed intellectual property pertaining to MNPR-101, giving Monopar full ownership and title to its lead MNPR-101 radiopharmaceutical platform. Both companies will share ownership of the filed patent application on the use of PCTA as a linker with Ac-225, which has shown superior binding and yield with Ac-225 over the current industry-leading linker, DOTA. “We are excited about the evolution of our collaboration, the promising potential of the MNPR-101 radiopharma platform, and the long-term access to a high-quality source of Ac-225 that can support our current development programs and potential future commercial products,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer. “Using our proprietary electron accelerator technology, NorthStar is poised to be the first commercial-scale producer of non-carrier added (n.c.a.) Ac-225. We’re delighted to continue and extend our collaboration with Monopar and support development of its exciting MNPR-101 radiopharma platform focused on therapeutic agents to treat aggressive cancers,” said Frank Scholz, PhD, NorthStar’s Chief Executive Officer. About Monopar Therapeutics Inc. (Monopar) Monopar Therapeutics is a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, including Phase 1-stage MNPR-101-Zr for imaging advanced cancers and late preclinical-stage MNPR-101 radio-immuno-therapeutic (RIT) for the treatment of advanced cancers. For more information, visit: www.monopartx.com. About NorthStar Medical Radioisotopes, LLC (NorthStar) NorthStar Medical Radioisotopes is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies. NorthStar routinely produces copper-67 (Cu-67) and is poised to be the first commercial-scale producer of non-carrier-added (n.c.a.) actinium-225 (Ac-225). The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements concerning: that NorthStar will provide actinium-225 for Monopar’s development and potential future commercial programs; the promising potential of Monopar’s MNPR-101 radiopharma platform, and the long-term access to a high-quality source of Ac-225 that can support Monopar’s current development programs and potential future commercial products; that NorthStar is poised to be the first commercial-scale producer of non-carrier added (n.c.a.) Ac-225; and that NorthStar will continue to support development of Monopar’s exciting MNPR-101 radiopharma platform focused on therapeutic agents to treat aggressive cancers. The forward-looking statements involve risks and uncertainties including, but not limited to: that Monopar’s and shared intellectual property may not result in allowed patents; that if allowed, the patents may be too narrow in scope to provide protection needed to successfully develop the radiopharma program; that NorthStar may not be able to supply Ac-225 at quantities needed, if at all; that NorthStar may not be the first commercial-scale producer of n.c.a. Ac-225; that Monopar may expend available funds sooner than anticipated or require additional funding due to change in circumstances or unanticipated events; that future preclinical or clinical data will not be as promising as the data to date; not successfully enrolling the MNPR-101-Zr Phase 1 clinical trial if at all; that MNPR-101-Zr and/or MNPR-101 conjugated to a therapeutic radioisotope may cause unexpected serious adverse effects or fail to image or be effective against the cancer tumors in humans; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s and/or NorthStar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. CONTACTS: For Monopar Therapeutics Inc.Investor RelationsKim R. TsuchimotoChief Financial Officerkimtsu@monopartx.com Follow Monopar on social media for updates:X (formerly Twitter): @MonoparTx LinkedIn: Monopar Therapeutics For NorthStar Medical Radioisotopes, LLC :Investor Relations:Paul EstremExecutive Vice President and Chief Financial Officerpestrem@northstarnm.com Media/Corporate:Alison HessVice President, Chief of Staffahess@northstarnm.com

Phase 1License out/in

25 Apr 2024

·www.globenewswire.com

Guerbet : Q1 2024 revenue.

Q1 2024 revenue Quarterly activity Revenue: €194.3m, up 8.8% at CER1Growth remains particularly strong in Asia (+26.8% at CER) and the Americas (+20.1% at CER); the EMEA region (-6.2% at CER) was temporarily impacted by the reform of the supply of contrast products in France Annual targets confirmed Revenue: expected growth of over 8% like-for-like and at CERProfitability: restated EBITDA margin rate2 higher than in 2021 (14.4%) Villepinte, 25 April 2024, 5.45 pm: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is publishing its revenue for the first fiscal quarter. At 31 March 2024, the Group’s sales totalled €194.3m, up 7.6% compared with the same period in 2023. Given an unfavourable foreign exchange effect of €2.2m, largely linked to Asian currencies, revenue at CER1 was up 8.8% over the period. Geographical breakdown of consolidated Group revenue (IFRS) In millions of euros,at 31 March 2024Q1 2023*Q1 2024% changeQ1 2024At CER1% changeSales in EMEA89.083.9-5.8%83.6-6.2%Sales in the Americas47.557.4+21%57.0+20.1%Sales in Asia44.152.9+20%55.9+26.8%Total180.6194.3+7.6%196.5+8.8% *Revenue for Q1 2023 has been restated to include Intrasense, which has been consolidated since 1 January 2023. In the EMEA region, the Group generated revenue of €83.9m in the first quarter, down 5.8% (-6.2% at CER) mainly owing to the dip in sales volumes in France. This trend stems directly from the implementation on 1 March 2024 of the reform of the supply circuit for contrast products, which caused difficulties in order intakes with radiologists. The Group expects to largely catch up on the resulting delays in sales in the second quarter of 2024. In the Americas, sales totalled €57.4m, up 21.0% over the period (+20.1% at CER). Sales caught up strongly for the second consecutive quarter following the return to historic production levels at the Raleigh site in North Carolina. Group revenue in Asia was €52.9m, with continued strong growth momentum (+20%) driven by the performances of China, South Korea and Japan. The total includes a negative currency effect (-€3.0m) linked in particular to the further depreciation of the yen. At CER, sales in Asia rose 26.8% in first-quarter 2024, confirming the Group’s ambitions in this region. Breakdown of consolidated Group revenue (IFRS) by activity In millions of euros,at 31 March 2024Q1 2023*Q1 2024% changeQ1 2024At CER1% changeDiagnostic Imaging 160.8173.6+7.9%175.5+9.1%MRI60.758.2-4.1%58.4-3.7%X-ray100.2115.4+15.2%117.1+16.9%Interventional Imaging19.820.7+4.4%21.0+6.1%Total180.6194.3+7.6%196.5+8.8% 1 Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year.*Revenue for Q1 2023 has been restated to include Intrasense, which has been consolidated since 1 January 2023. Diagnostic Imaging revenue increased 7.9% in Q1 2024 (+9.1% at CER) to €173.6m. MRI activity was down 3.7% at CER. This decline resulted from the postponement of several substantial orders in the MRI franchise (Dotarem® / EluciremTM) in France, all of which will be booked in the second quarter of 2024.X-ray revenue increased 16.9% at CER over the period, a remarkable increase driven by all the division’s products, particularly Xenetix®. In Interventional Imaging, revenue rose 6.1% at CER in Q1 2024 on continued favourable momentum for Lipiodol®, fuelled by volumes and prices alike. All financial targets confirmed for 2024 The highly positive trend overall at the start of the year boosts Guerbet’s confidence for the full year. In a buoyant contrast products market, Group business will be bolstered by the ramp-up of the MRI franchise, growth in Optiray® sales, and continued favourable momentum for Lipiodol®. At the same time, operating profitability will benefit from the change in the product mix and the continued rise in prices, while cash generation will improve considerably, particularly as inventory levels return to normal. Given these circumstances, Guerbet is confirming its forecast of sales growth of over 8% in 2024 like-for-like and at CER and expects its adjusted EBITDA margin rate to exceed that of 2021 (14.4%). Free cash flow is expected to be in positive territory for the full year. Next events : Annual Shareholders' Meeting for fiscal year 202324 May 2024 Publication of 1st half 2024 revenue 25 July 2024 after market close About GuerbetAt Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast media for 97 years, with more than 2,920 employees worldwide, we continuously innovate and devote 10% of our sales to research and development in four centres in France, the United States and Israel. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €786 million in revenue in 2023. Forward-looking statementsCertain information contained in this press release does not reflect historical data but constitutes forward-looking statements. These forward-looking statements are based on estimates, forecasts, and assumptions, including but not limited to assumptions about the current and future strategy of the Group and the economic environment in which the Group operates. They involve known and unknown risks, uncertainties, and other factors that may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly by these forward-looking statements.These forward-looking statements are valid only as of the date of this press release, and the Group expressly disclaims any obligation or commitment to publish an update or revision of the forward-looking statements contained in this press release to reflect changes in their underlying assumptions, events, conditions, or circumstances. The forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and are generally beyond the Group’s control. These risks and uncertainties include but are not limited to the uncertainties inherent in research and development, future clinical data and analyses (including after a marketing authorization is granted), decisions by regulatory authorities (such as the US Food and Drug Administration or the European Medicines Agency) regarding whether and when to approve any application for a drug, process, or biological product filed for any such product candidates, and their decisions regarding labeling and other factors that may affect the availability or commercial potential of such product candidates. A detailed description of the risks and uncertainties related to the Group’s activities can be found in Chapter 4.9 “Risk factors” of the Group’s Universal Registration Document filed with the AMF (French financial markets authority) under number D.24-0224 on April 3, 2024, available on the Group’s website (www.guerbet.com). 1 Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year.2 Restated EBITDA margin rate : excluding non-recurring costs related to the optimisation of the operating plan and changes in the sales model. Attachment CP CA T1 2024_VFinale EN

Financial Statement

19 Oct 2023

·www.globenewswire.com

GUERBET : Revenue at 30 September 2023.

Revenue at 30 September 2023 Activity 9-month revenue: €573.9 million, up 2.7% at CER1 Third-quarter sales remained very strong in Asia (+15.2% at CER), were stable in EMEA (+0.6%) and showed a smaller decline in the Americas (-5.2%)Expecting double-digit activity growth in the fourth quarter of 2023 thanks to the surge in sales of EluciremTM and strong momentum in Interventional Imaging Financial targets confirmed 2023 revenue up by more than 5% like-for-like and at CERRestated EBITDA margin2 of around 11% in 2023, before returning in 2024 to a higher level than in 2021 (14.4%) Villepinte, 19 October 2023: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is publishing its revenue for the period to 30 September 2023. Over the first nine months of the year, Group sales came to €573.9 million, up 0.8% on the same period in 2022. Business activity reflected a negative forex effect of €10.4 million. At CER1, revenue for the first nine months grew by 2.7%. Sales in the third quarter of 2023 came to €195.2 million, up 2.3% at CER, after rising by 2.8% during the first half of the financial year. Taking into account the expected ramp-up in EluciremTM sales in the fourth quarter, this scenario supports Guerbet’s financial targets for the full year and for next year. Geographical breakdown of consolidated Group revenue (IFRS) In millions of euros,at 30 September 20239 months 20229 months 2023At current exchange rates% change9 months 2023At CER1% changeSales in EMEA245.2258.5+5.4%258.6+5.5%Sales in the Americas182.5160.9-11.8%161.5-11.5%Sales in Asia141.4154.4+9.2%164.2+16.1%Total569.2573.9+0.8%584.3+2.7% 1Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year. In the EMEA region, the Group saw an increase in 9-month sales of 5.4% at current exchange rates and 5.5% at CER, driven by the increase in volumes and positive price effects. In the third quarter, revenue for the region came to €79.9 million, with moderate growth (+0.6% at CER) linked to a particularly high comparison base. In the Americas, sales for the period to end-September 2023 fell by 11.8% at current exchange rates and by 11.5% at CER. As expected, the decline in revenue slowed significantly in the third quarter to -5.2% at CER. After the complete normalisation of production rates during the first half of 2023, the Raleigh (North Carolina) site was again able to increase its production capacity with a view to increasing its sales - of EluciremTM in particular - in the fourth quarter. In Asia, sales growth over the 9-month period was +9.2%, incorporating a particularly substantial negative forex effect of -€9.8m (depreciation of Chinese, Japanese and Korean currencies) during the period; at CER, growth was +16.1%, a remarkable performance driven mainly by China (+39%), which continued to benefit from the introduction of direct distribution in 2022. In the third quarter alone, sales in Asia were up 15.2% at CER. Breakdown of consolidated Group revenue (IFRS) by activity In millions of euros,at 30 September 20239 months 20229 months 2023At current exchange rates% change9 months 2023At CER1% changeDiagnostic Imaging 502.2506.4+0.8%515.3+2.6%MRI192.4187.3-2.7%189.4-1.6%X-ray309.8319.0+3.0%325.8+5.2%Interventional Imaging67.067.5+0.7%69.0+3.0%Total569.2573.9+0.8%584.3+2.7% 1Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year. Revenue from Diagnostic Imaging at CER was up 2.6% at 30 September 2023 (+0.8% at current exchange rates) and up 1.2% in the third quarter. Note that the X-ray division now includes the revenue of Intrasense, consolidated since 1 January 2023. In MRI, sales for the 9-month period were down 1.6% at CER due to a contraction in activity in the third quarter of 2023. This reflects: A negative price effect linked to the price pressure exerted by the generic product for Dotarem® on the US market.Sales of EluciremTM which slowed in the third quarter due to longer-than-expected approval times (formulary process) in US hospitals, with a strong catch-up effect expected from the fourth quarter of 2023. In the X-ray division, revenue rose by 5.2% over the first nine months at CER, marked by a sharp acceleration in growth in the third quarter (+8.7%), again due to a sharp increase in sales of Xenetix®. In Interventional Imaging, sales at CER were up 3.0% compared with the first nine months of 2022. After a negative comparison base effect in the Asia-Pacific region in the first half of 2023, revenue for the third quarter rose by a sharp 10.3%, driven by strong sales of Lipiodol®. Financial targets for 2023 and 2024 confirmed Activity continues to be underpinned by robust volumes and broadly positive price effects (with the exception of Dotarem®), reflecting the Group’s ability to pass on cost increases to its customers (iodine in particular). In the fourth quarter of 2023, Guerbet expects double-digit sales growth driven by a very strong rebound in activity in the United States, linked in particular to the ramp-up of EluciremTM sales once the current approval processes are completed, and to continued favourable trends in Interventional Imaging. For the full year, Guerbet confirms that it is targeting revenue growth of more than 5% like-for-like and at CER. It still expects a restated EBITDA2 to revenue ratio of around 11% in 2023, before returning in 2024 to a higher level than in 2021 (14.4%). As a reminder, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a favourable opinion on the granting of marketing authorisation for Elucirem™ in the European Union for use in adults and children aged two and older for contrast-enhanced MRI. The European Commission is expected to make its decision by the end of 2023. Next event: Publication of full-year revenue8 February 2024 after market close About Guerbet At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast media for 95 years, with more than 2,600 employees worldwide, we continuously innovate and devote 10% of our sales to research and development in four centres in France, Israel, and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €753 million in revenue in 2022. Forward-looking statements Certain information contained in this press release does not reflect historical data but constitutes forward-looking statements. These forward-looking statements are based on estimates, forecasts, and assumptions, including but not limited to assumptions about the current and future strategy of the Group and the economic environment in which the Group operates. They involve known and unknown risks, uncertainties, and other factors that may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly by these forward-looking statements.These forward-looking statements are valid only as of the date of this press release, and the Group expressly disclaims any obligation or commitment to publish an update or revision of the forward-looking statements contained in this press release to reflect changes in their underlying assumptions, events, conditions, or circumstances. The forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and are generally beyond the Group’s control.These risks and uncertainties include but are not limited to the uncertainties inherent in research and development, future clinical data and analyses (including after a marketing authorization is granted), decisions by regulatory authorities (such as the US Food and Drug Administration or the European Medicines Agency) regarding whether and when to approve any application for a drug, process, or biological product filed for any such product candidates, and their decisions regarding labeling and other factors that may affect the availability or commercial potential of such product candidates. A detailed description of the risks and uncertainties related to the Group’s activities can be found in Chapter 4.9 “Risk factors” of the Group’s Universal Registration Document filed with the AMF (French financial markets authority) under number D.23-0203 on March 31, 2023, available on the Group’s website (www.guerbet.com). 1 Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year.2 Excluding non-recurring costs related to the optimisation of the operating plan and changes in the sales model. 2 Excluding non-recurring costs related to the optimisation of the operating plan and changes in the sales model. Contacts : Guerbet Jérôme Estampes, Chief Financial Officer +33.1.45.91.50.00 / jerome.estampes@guerbet.comClaire Lauvernier, Communications Director +33.6.79.52.11.88 / claire.lauvernier@guerbet.com Actifin Marianne Py, Financial Communications +33.1.80.48.25.31 / mpy@actifin.frJennifer Jullia, Press +33.1.56.88.11.19 / jjullia@actifin.fr Attachment 23 1019 Guerbet_ CP CA T3 VA Vdef

Financial StatementBiosimilar

100 Deals associated with Gadoterate Meglumine

External Link

KEGG	Wiki	ATC	Drug Bank
D03355	Gadoterate Meglumine	V08CA02	DB09132

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Vascular Diseases	US	Guerbet LLC	20 Mar 2013
Contrast agents	JP	Guerbet Japan KK	22 Sep 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Central Nervous System Diseases	Phase 3	AR	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	AT	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	BR	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	CL	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	FR	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	DE	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	IT	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	KR	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	ES	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	GB	Guerbet LLC	01 Sep 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01806740 (DCE-MRI, CTgov)	Phase 4	Advanced Hepatocellular Carcinoma	37	Gadoterate meglumine	ubcqnmxvjz(ztwithjkwg) = btdssegglv pdktxhxbji (ioaalmzfdx, hragytxgcl - scmkqsrwln) View more	-	08 Aug 2019
NCT02411201 (CTgov)	Phase 4	-	51	DOTAREM	qchjckmtjo(ddrqymguau) = qzmlmouhjn mslayrkujd (evdercoukl, kjirtzlipx - txedhpfefo) View more	-	09 Mar 2017
NCT02070380 (CTgov)	Phase 4	Brain Diseases	179	Dotarem (MultiHance 0.1 mmol/kg Arm (Reader 1))	knqihekqld(qernqavtbj) = fextrfeopv widtamncdy (ldfbbuxhwg, jqfylpqkiu - ilgzruktrm) View more	-	10 Jan 2017
				Dotarem (MultiHance 0.1 mmol/kg Arm (Reader 2))	knqihekqld(qernqavtbj) = vvysnbowdi widtamncdy (ldfbbuxhwg, kmxbysgtmp - txwoisohoy) View more
NCT01211873 (CTgov)	Phase 3	Central Nervous System Diseases	416	Dotarem (gadoterate meglumine) (Dotarem (Gadoterate Meglumine ))	czlywjanas(pmgmycecrr) = sdyldngite vpdeqequwb (tvmeumpmpn, ljhpzddyka - vwquqdizfy) View more	-	29 May 2014
				Magnevist (gadopentetate dimeglumine) (Magnevist (Gadopentetate Dimeglumine))	czlywjanas(pmgmycecrr) = gtfmpnrtlm vpdeqequwb (tvmeumpmpn, wqkfjbxycf - ombqeesziy) View more
NCT01026389 (CTgov)	Phase 4	vascular arterial disease \| Peripheral Arterial Disease	189	Gadovist (Gadovist)	pyjpslgqch(robqwrrtfv) = zralgeqorl opvjlzaylz (rhkpmocidd, vhlncoampn - xeiscphmos) View more	-	11 Dec 2012
				Dotarem (Dotarem, Interventional)	pyjpslgqch(robqwrrtfv) = kapineetrg opvjlzaylz (rhkpmocidd, oacyjxuxfd - awezgepsiw) View more

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