PRESS RELEASE

Life Molecular Imaging Enters Agreement With Lantheus to Sub-License its Radiotheranostic Agent RM2 Targeting GRPR in Prostate and Breast Cancers

Joining forces to accelerate development and to create a potential new option to expand access to radiotheranostics for more cancer patients

Berlin, GERMANY, June 27, 2024 – Life Molecular Imaging (“LMI”), a wholly owned subsidiary of Life Healthcare Group, has entered into a contract with Lantheus Holdings Inc. (“Lantheus”), to sub-license LMI’s early-stage radiotheranostic product (“RM2”). RM2 includes the clinical-stage radiotherapeutic and radiodiagnostic pair, referred to as 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2. The agreement includes global rights (1) to this radiotheranostic product for an upfront payment of $35 million and potential regulatory milestone payments plus royalties. The sub-licensing agreement secures Lantheus’ rights to develop the product and complete the early development in collaboration with LMI. LMI is uniquely positioned to assist in this area. The acquisition of RM2 will strengthen Lantheus’ presence in prostate cancer and expands its pipeline to include breast and other cancers.

“With Lantheus’ experience developing and providing access to radiotheranostics in cancer, we are confident in our decision to hand them the reins for this promising theranostic pair and are honored to work with them toward improving the future of cancer patients,” said Ludger Dinkelborg, CEO, Life Molecular Imaging.

Lantheus’ acquisition of worldwide rights to 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2 underscores its dedication to pioneering cancer therapies and marks a significant step towards addressing unmet medical needs in prostate and breast cancer treatment. “While new PSMA-targeted diagnostics and therapeutics are transforming prostate cancer care, there are many patients for whom PSMA-targeted therapy may not be appropriate,” said Brian Markison, Lantheus CEO. “Targeting GRPR with 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2 creates a potential new option to expand access to radiotheranostics for more prostate cancer patients. This strategic move not only expands our therapeutic offerings but also opens avenues for commercial synergies.”

RM2 was discovered at the Universities Bern and Basel and the development was originally performed by Bayer Pharma AG. It was subsequently licensed to LMI. 68Ga-DOTA-RM2 targets cancers overexpressing GRPR, such as prostate, breast, lung, pancreatic, colorectal, gastric and ovarian cancers and has been extensively studied in various tumor types. First-in-human dosimetry showed a favorable safety and dosimetry profile and confirm preclinical data demonstrating dose-dependent efficacy of 177Lu-DOTA-RM2. Lantheus intends to begin a Phase 1/2a study with 177Lu-DOTA-RM2 in prostate cancer patients in 2025. 68Ga-DOTA-RM2 will be used as a companion diagnostic.

About GRPR
Gastrin releasing peptide receptor (GRPR) is a member of the bombesin G protein-coupled receptor family. It has been found to be overexpressed in multiple cancers, including prostate, breast, lung and others (2).

About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI) is a global radiopharmaceutical company dedicated to developing and offering novel cutting-edge radiopharmaceuticals that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. LMI is an affiliate of the Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit https://life-mi.com.

About Life Healthcare Group
Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years’ experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative radiopharmaceuticals. Visit: https://www.lifehealthcare.co.za/ | https://life-mi.com/

About Lantheus 
Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for more than 65 years. For more information, visit www.lantheus.com.

Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “intends,” “may,” “potential,” “will,” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause the actual results to materially differ from those described in the forward-looking statements include: (i) the timing and potential outcomes of clinical studies using 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2, including the Phase 1/2a study; (iii) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and other regulatory authorities for 177Lu-DOTA-RM2 or 68Ga-DOTA-RM2; (iv) the ability to launch 177Lu-DOTA-RM2 or 68Ga-DOTA-RM2 as commercial products; (v) the market receptivity to 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2 as radiotheranostics; (vi) the existence, availability and profile of competing products; (vii) the ability to obtain and maintain adequate coding, coverage and payment for 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2; (viii) the safety and efficacy of 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2; (ix) the intellectual property protection of 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2; (x) the ability to successfully develop and scale the manufacturing capabilities to support the launch of 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2; and (xi) the risks and uncertainties discussed in the Lantheus’ filings with the Securities and Exchange Commission (including those described in the Risk Factors section in the most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q).

(1) Lantheus’ global rights are exclusive for therapeutic fields in all countries and diagnostic fields in the Americas and co-exclusive with Life Molecular for diagnostic fields outside of the Americas

(2) Ma, Y., Gao, F. Advances of radiolabeled GRPR ligands for PET/CT imaging of cancers. Cancer Imaging 24, 19 (2024). https://doi.org/10.1186/s40644-024-00658-y

For media queries:
Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging
Tel: +1.484.735.2840 |  b.hahn@life-mi.com

Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

DRUG INTERACTIONS

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

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