NorthStar Medical Radioisotopes Provides Updates on Corporate Progress

April 16, 2021 —NorthStar Medical Radioisotopes美国有限责任公司(LLC)是一家用于医学成像和治疗应用的放射性药物的开发、生产和商业化的全球创新者，今天宣布了一项公司更新，强调其在过去12个月的关键项目的进展和即将到来的里程碑。

“NorthStarhas made significant advancements across our portfolio over the past year and we are excited about the Company’s future,” saidStephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. “In advancing our plans to ensure reliable, non-uranium based radioisotope supply for the United States,RadioGenix System(technetium Tc 99m generator) sales continue to increase. Our facility expansions, designed to ensure additional production capacity and supply of Mo-99, are nearing completion. Additionally, NorthStar has broadened its technology platform to address critical unmet needs in radioisotope supply by advancing commercial-scale development of promising therapeutic radioisotopes, and our novel cardiovascular SPECT imaging agent,FibroScint, is advancing towards eIND-enabling studies. We are collaborating with IBA to increase global availability ofTc-99and with Monopar Therapeutics to develop a targeted radiotherapeutic agent for severe COVID-19 and other acute respiratory diseases. NorthStar anticipates sustained progress and growth as we expand our horizons globally and execute strongly in our mission to provide reliable radioisotope supply to support patients’ healthcare needs.”

Corporate development and industry leadership
NorthStar is firmly positioned for long term growth and increasing global industry leadership.

• In March 2021, NorthStar implemented organizational changes to drive focused growth for its therapeutic and specializedSPECTradioisotopes business.新的结构使北极星公司能够推进其放射性同位素开发和商业化规划工作，同时进行增加美国Mo-99产能和产量的扩建计划。In conjunction with other organizational changes, NorthStar appointedDave Wilson, RPh, BCNP, as Vice President, Advanced Radiopharmaceutical and Therapeutic Technologies to lead these initiatives to commercialization.
• In October 2020, NorthStar promoted Chief Financial OfficerPaul Estrem他被任命为NorthStar董事会的管理人员。Mr. Estrem has been instrumental in building momentum to create and expand NorthStar’s product portfolio. The expanded role positions him to guide NorthStar’s corporate strategy and drive its planned corporate and business development initiatives.
• NorthStar is a widely recognized leader in radioisotope technology development and commercialization and the nuclear medicine industry.In July 2020, NorthStar led an update on its ongoing commercial Mo-99 production, expansion plans and the RadioGenix System at theSociety of Nuclear Medicine and Molecular Imaging(SNMMI) event, “Industry Outlook on Current and Future Mo-99 Supply.” In September 2020, then-Deputy Secretary of Energy Mark W. Menezes visited NorthStar to learn about its U.S.-based Mo-99 production, underscoring the Department of Energy’s commitment to reviving and expanding the U.S. nuclear sector and to reduce dependence on foreign imports while bringing new opportunities to the heartland.

RadioGenix System commercial progress
NorthStar’s innovative, high tech radioisotope separation platform, the RadioGenix System, uses U.S.-produced, non-uranium based Mo-99 to produce Tc-99m, the most widely used medical radioisotope that informs patient management decisions in 40,000 U.S. imaging studies daily.

• RadioGenix System sales continue to steadily increase, with hundreds of thousands of doses provided for patients’ diagnostic imaging studies to date.Since becoming commercially available, RadioGenix Systems have provided reliable Tc-99m supply for customers with U.S.-produced Mo-99, despite intermittent shortages from suppliers using legacy, uranium-based production methods.
• Ongoing product development programs continue to maximize operational utility and efficiency in producing Tc-99m.Since initial approval in 2018, NorthStar has received five subsequent Food and Drug Administration (FDA) approvals, the latest in January 2021 for concentrated Mo-98 and RadioGenix System updates.

Commercial U.S. Mo-99 manufacturing and production expansion
NorthStar is the only commercialized U.S. producer of Mo-99. It is aggressively expanding and establishing dual production and processing hubs for additional Mo-99 capacity to better meet customer demand and to ensure sustainable U.S. supply. Two facility expansion projects nearing completion in Beloit, Wisconsin, will augment current Mo-99 production and processing in Columbia, Missouri, conducted in partnership with the University ofMissouri Research Reactor(MURR).

• NorthStar’s Isotope Processing facility in Beloit will complement current Columbia processing capacity for Mo-99 source vessels. The facility will enable NorthStar to more than double its production of Mo-99, used with RadioGenix Systems to produce Tc-99m. Equipment installation is nearing completion, testing is underway with full qualification to be completed by the end of 2021. NorthStar expects FDA approval for the Beloit Isotope Processing facility in 2022.
• NorthStar’s Accelerator Production facility expansion in Beloit will ensure additional Mo-99 capacity, enable flexible production scheduling and minimize customer supply risks.Like other NorthStar processes, accelerator production of Mo-99 using the “neutron knock-out” method is non-uranium based and highly efficient. The first pair of IBA electron beam accelerators will arrive for installation at NorthStar’s facility in April 2021. The Company anticipates accelerator production to begin in 2023, pending appropriate licensure and FDA approval.
• In January 2021, the FDA approved NorthStar’s process for producing Mo-99 from concentrated Mo-98 and related software updates for the RadioGenix System.This approval is the first and only commercial-scale production of Mo-99 using concentrated Mo-98 technology. It increases NorthStar’s Mo-99 production capacity up to four times above its current technology, to provide higher activity source vessels to better meet customer demand.
• FDA approval of concentrated Mo-98 allows NorthStar to serve as much as 40% of the U.S. demand for Mo-99 by the end of 2021.The Company expects that within three to five years, it will have the capability to regularly supply an estimated 65% of U.S. Mo-99 demand, and up to 100% of U.S. demand in an emergency.

Commercial-scale therapeutic radioisotope production − Ac-225 and Cu-67
NorthStar is poised to be the first commercial-scale supplier of the important therapeutic radioisotopes Ac-225 and Cu-67, both used to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Current production technology limitations and resultant limited supply have severely constrained development of these promising therapies.

• NorthStar正在应用其商业规模的放射性同位素生产专业知识，提供可靠的Ac-225和Cu-67供应，以推进临床研究和商业放射性药物产品。The Company is leveraging the same technology expertise demonstrated by the successful launch of the RadioGenix System and non-uranium based Mo-99 supply.
• NorthStar与几家大型制药公司建立了合作关系，提供Ac-225和Cu-67的临床试验供应和商业规模的数量。The Company expects to secure long-term supply agreements during 2021.

Specialized SPECT portfolio
NorthStar is actively developing and growing its strategic portfolio of specializedsingle photon emission computed tomography(SPECT) radiopharmaceuticals to meet increasing clinical needs for SPECT imaging, driven by scientific advancements in cardiology and oncology.

• NorthStar has an exclusive, global licensing agreement with Capella Imaging, Inc. for FibroScint, a novel fibrin-specific diagnostic imaging agent labeled with Tc-99m for SPECT imaging.Pending successful development, FibroScint will have an initial application in the imaging of thrombus (blood clots) associated with left ventricular assist devices (LVADs), and other potential imaging applications in deep vein thrombosis and pulmonary embolism. NorthStar intends to use RadioGenix System-produced Tc-99m in planned clinical studies of FibroScint. Advanced preclinical development is underway, with an exploratory Investigational New Drug (IND) filing for a Phase 1 study planned for early 2022.
• NorthStar is evaluating additional potential opportunities in specialized SPECT radiopharmaceuticals to address unmet healthcare needs and synergies with its product portfolio.

Partnerships and collaborations
NorthStar selectively partners with leading organizations in strategic collaborations designed to augment its portfolio, maximize synergies and drive growth in areas of unmet medical need.

• In June 2020, NorthStar and Monopar Therapeutics Inc. (Nasdaq: MNPR) announced a collaboration to help combat severe COVID-19 and other severe respiratory diseases.The collaboration will couple Monopar’s targeted monoclonal antibody MNPR-101 to a therapeutic radioisotope supplied by NorthStar to create a highly selective agent with potential to spare healthy cells while quickly reducing cytokine storms and their harmful systemic effects. In December 2020, Monopar and NorthStar announced that a clinical candidate was selected, enabling preclinical studies to begin and advancing one step closer to reaching human clinical trials.
• In March 2021, NorthStar and IBA (Ion Beam Applications S.A., EURONEXT) announced a collaboration to increase global availability of Tc-99m, with potential to result in non-uranium Mo-99 being the leading worldwide source of Tc-99m. Worldwide, diagnostic imaging studies using Tc-99m inform healthcare decisions for approximately 30 million patients annually. The collaboration enables companies outside the United States to access Tc-99m Generation Systems (TCM Generation Systems) that utilize NorthStar’s proprietary non-uranium based Mo-99 produced using IBA’s accelerators and beamlines. Early discussions with interested companies are underway.

About the RadioGenix System (Technetium Tc 99m Generator)
The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium based molybdenum-99 (Mo-99) for the production of the important medical radioisotope, technetium-99m (Tc-99m). Prior to availability of RadioGenix technology, the U.S. supply chain for Mo-99 has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare. Approved by the U.S. Food and Drug Administration (FDA) in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium based Mo-99, designed to help alleviate shortage situations and expand domestic supply.

Indication and Important Risk Information about the RadioGenix^®System and Sodium Pertechnetate Tc 99m Injection USP

The RadioGenix系统是一个锝Tc-99m发生器，用于生产过锝酸钠Tc 99m注射，USP。高锝酸钠Tc 99m注射液是一种放射性诊断剂，可用于制备fda批准的诊断放射性药物。

Sodium Pertechnetate Tc 99m Injection is also indicated in

• Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
• Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.

IMPORTANT RISK INFORMATION

• 过敏反应(皮疹、荨麻疹或瘙痒)包括过敏反应在使用过锝酸钠Tc 99m注射液后已被报道。监测所有患者的过敏反应。
• Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
• Unintended Re-186 Exposure: Discard the first eluate from every new Potassium Molybdate Mo-99 Source Vessel to minimize the risk of unintended radiation exposure from Rhenium Re-186.
• Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
• Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
• Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kit/packs, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 24 hour expiration time from elution is reached, whichever occurs earlier.

要报告疑似不良反应，请致电1-844-438-6659联系北极星医疗放射性同位素有限责任公司;or FDA at 1-800-332-1088 orwww.fda.gov/medwatch.

For RadioGenix System version 1.2 Full Prescribing Information,click hereor visithttps://www.northstarnm.com/wp-content/uploads/2020/12/radiogenix-system-12-package-insert-rev-03-29-dec-2020.pdf.

Related Tc-99m Content:

How Nuclear Fusion is Revolutionizing Medical Isotope Production

FDA Approves Additional Molybdenum-99 (Mo-99) Filling Lines at NorthStar Medical Radioisotopes

Medical Isotope Industry Opposes Export of Highly Enriched Uranium for IRE

IBA and NorthStar Medical Radioisotopes Expand Collaboration to Enable Global Availability of Tc-99m