Blue Earth Diagnostics, a Bracco Company, Announces Results Evaluating Diagnostic Performance of POSLUMA® (Flotufolastat F 18) and Clinical Trial Enrollment in African American Men with Prostate Cancer

PRESS RE   This press Blue Ear POSLUM  Post‐hoc American  Study  MONROE and recog radiophar SPOTLIGH in patient cancer in POSLUMA detection scan, cons African Am types of o Tomograp Phase 3 S (https://d POSLUMA membran are candid prostate‐s “Prostate more like Urology, U encourag represent populatio outcomes LEASE  s release is fo rth Diagnostic MA® (Flotufol c analysis from ns and other p achieved 17% E TOWNSHIP,  gnized leader rmaceuticals, HT study (NCT ts with recurre African Amer A and the rate rate was high sistent with t merican men oncology clini phy in African POTLIGHT Stu doi.org/10.10 A is approved ne antigen (PS dates for initi specific antige cancer is the ly to die from University of ing that Afric tation of the U ons are less us s.” or U.S. audien cs, a Bracco C lastat F 18) a m Phase 3 SP patient group % African Ame N.J., and OXF in the develo today annou T04186845), w ent prostate c rican men, a s e of enrollme h among Afri he 87% detec in the SPOTL cal trials (8.5% American Pa udy” has bee 16/j.adro.202 in the United SMA) positive al definitive t en (PSA) leve e most comm m the disease Alabama at B an American U.S. populatio seful for clinic nces only  Company, An nd Clinical Tr OTLIGHT trial ps for FDA‐app erican enrollm FORD, UK, Ju opment and c unced results which assesse cancer.3,4 Bas sub‐analysis w nt for African can American ction rate for LIGHT study w %).1,2 The ma atients with S n published o 24.101571), a d States for po e lesions in me therapy or wi l. only diagnose than White m Birmingham H enrollment in on8, because cal decision‐m   nnounces Res rial Enrollmen Cancer  l demonstrate proved POSLU   ment, more th trials2     ly 30, 2024 – commercializa of a post‐hoc ed FDA‐appro ed on the hig was conducte n American m n patients, wi all other pati was twice the nuscript, “18F uspected Pro online in the j and will appea ositron emiss en with prost th suspected ed cancer am men,”5‐7 said S Heersink Scho n the SPOTLIG results from making and ca sults Evaluati nt in African  ed consistent UMA in men w han twice the – Blue Earth D ation of innov c analysis of d oved POSLUM gh mortality a ed to evaluate en in the tria th 93% found ients in the st enrollment t F‐Flotufolasta ostate Cancer journal Advan ar in an upco sion tomogra tate cancer w recurrence b mong African A Soroush Rais‐ ool of Medicin GHT trial clos oncology tria an contribute ng Diagnostic American Me t performance with recurren e average for  Diagnostics, a vative PET data from the MA® (flotufola and prevalenc e the perform al. Results sho d to have a po tudy.1 The 17% typically repo t Positron Em Recurrence: nces in Radiat ming print iss phy (PET) of p with suspected based on elev American me ‐Bahrami, MD ne, Birmingha ely aligns wit als with low d e to racial disp c Performanc en with Prost e between Af nt prostate ca oncology clin Bracco comp Phase 3 stat F 18) inje ce of prostate mance of owed that the ositive POSLU % participatio rted in other mission Findings from tion Oncology sue. prostate‐spec d metastasis w vated serum en, who are tw D, Departmen am, Ala. “It is th their 14% diversity parities in can ce of  tate  frican  ancer1   nical  pany ection e e UMA on of m the y cific who wice nt of ncer 2 The U.S. Food and Drug Administration (FDA) has issued draft guidance on clinical trial diversity and organizations such as the American Society of Clinical Oncology (ASCO) have called out the need for enriched diversity in oncology clinical trial participation.9,10 “Beyond validating the diagnostic performance of POSLUMA in African American men, findings from the SPOTLIGHT study provide useful considerations for planning future clinical trials, to facilitate patient enrollment and achieve clinical trial diversity,” said Marco Campione, Chief Executive Officer, Blue Earth Diagnostics. “The results achieved in African American men were derived from clinical sites across the United States, and further support the broad applicability of POSLUMA for its indicated use across the U.S. population as a whole.” FDA‐approved POSLUMA represents a newer class of high‐affinity PSMA‐targeted PET radiopharmaceuticals based on novel radiohybrid technology and leverages the high image quality of 18F‐labeled PSMA PET imaging to help facilitate detection of prostate cancer. It can provide clinically valuable information to guide patient management based on its high‐affinity PSMA binding, low urinary uptake and positive performance at very low PSA levels. POSLUMA is included in nationally recognized clinical oncology guidelines for prostate cancer, covered by the vast majority of insurance plans and is readily available for patients across the country through the network of Blue Earth Diagnostics’ commercial U.S. manufacturer and distributor, PETNET Solutions Inc, A Siemens Healthineers Company.   Indication and Important Safety Information About POSLUMA    INDICATION   POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate‐ specific membrane antigen (PSMA) positive lesions in men with prostate cancer • with suspected metastasis who are candidates for initial definitive therapy • with suspected recurrence based on elevated serum prostate‐specific antigen (PSA) level IMPORTANT SAFETY INFORMATION  Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non‐malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.  Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision‐making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.  POSLUMA use contributes to a patient’s overall long‐term cumulative radiation exposure. Long‐ term cumulative radiation exposure is associated with an increased risk for cancer. Advise 3 patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.  The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.  Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established. To report suspected adverse reactions to POSLUMA, call 1‐844‐POSLUMA (1‐844‐767‐5862) or contact FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch. Full POSLUMA prescribing information is available at www.posluma.com/prescribing‐information.pdf.    About Blue Earth Diagnostics Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well‐differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro‐oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com. About Bracco Imaging   Bracco Imaging S.p.A., part of the Bracco Group, is a world‐leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X‐ray imaging (including Computed Tomography‐CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose‐management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting‐edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com.   References 1. Rais‐Bahrami S, Fleming M, Gartrell B, et al. 18 F‐Flotufolastat Positron Emission Tomography in African American Patients with Suspected Prostate Cancer Recurrence: Findings from the Phase 3 SPOTLIGHT Study. Adv Clin Onc 2024; doi 10.1016/j.adro.2024.101571 2. Bebi T, Horovitz R, Blum K, et al. How granularity of data matters in understanding and accelerating racial diversity in U.S. clinical trials. J Clin  Oncol 2022;40 (Suppl 28):88. 3. Jani AB, Ravizzini G, Gartrell BA, et al. Diagnostic performance and safety of 18 F‐rhPSMA‐7.3 PET in men with suspected prostate cancer recurrence: Results from a phase 3, prospective, multicenter study (SPOTLIGHT) J Urol 2023;210:299‐311. 4. FDA. Highlights of prescribing information: Posluma (flotufolastat f 18) injection: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216023s000lbl.pdf; 2023. 5. Giaquinto AN, Miller KD, Tossas KY, et al. Cancer statistics for African American/Black people 2022. CA Cancer J Clin 2022;72:202‐229. 4 6. Frego N, Labban M, Stone BV, et al. Effect of type of definitive treatment on race‐ based differences in prostate cancer‐specific survival. Prostate 2023;83:1099‐1111. 7. Rais‐Bahrami S, Zhu Y. Disparities in prostate cancer diagnosis and management: Recognizing that disparities exist at all junctures along the prostate cancer journey. Prostate cancer and prostatic diseases 2023;26:441‐442. 8. Facts About the U.S. Black Population. Pew Research Center. Fact Sheet. January 14, 2024. https://www.pewresearch.org/social‐trends/fact‐ sheet/facts‐about‐the‐us‐black‐population/ 9. FDA. Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies  https://www.fda.gov/media/179593/download; 2024. 10. Oyer RA, Hurley P , Boehmer L, et al. Increasing racial and ethnic diversity in cancer clinical trials: An American Society of Clinical Oncology and Association of Community Cancer Centers joint research statement. Journal of Clinical Oncology 2022;40:2163‐2171. POSLUMA is a registered trademark of Blue Earth Diagnostics Ltd.   Contact:  For Blue Earth Diagnostics (U.S.)    Priscilla Harlan Vice President, Corporate Communications (M) (781) 799‐7917 [email protected] For Blue Earth Diagnostics (UK)   Clare Gidley Associate Director Marketing and Communications Tel: +44 (0)1865 784186 [email protected] Media     Sam Brown Inc. Mike Beyer (M) (312) 961‐2502 [email protected] # # # PP-rh-US-0523

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