[18F]DCFPyL

Recorded second quarter 2025 worldwide revenue of $378.0 million , GAAP fully diluted earnings per share of $1.12 , adjusted fully diluted earnings per share of $1.57 and free cash flow of $79.1 million Announced FDA acceptance of NDA for new formulation for piflufolastat F 18 PSMA PET imaging agent with a PDUFA date of March 6, 2026 Closed acquisition of Life Molecular Imaging in July, immediately expanding near- and long-term growth profile and commercial portfolio with Neuraceq® (florbetaben F 18 injection), a globally approved beta-amyloid targeted radiodiagnostic for Alzheimer's disease; FDA label expansion for Neuraceq in June Board of Directors authorized a program to repurchase up to $400 million of Lantheus common stock, replacing the 12-month program announced in November 2024 Provided updated corporate guidance for full year 2025 revenue and adjusted fully diluted earnings per share, reflecting the Life Molecular Imaging acquisition and current business outlook BEDFORD, Mass. , Aug. 06, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. ( Lantheus or the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today reported financial results for its second quarter ended June 30, 2025 . “In the second quarter and the month thereafter, we completed the acquisitions of both Evergreen Theragnostics and Life Molecular Imaging – key steps in executing our strategy to expand capabilities across the radiopharmaceutical value chain, diversify revenue, including with Neuraceq, and drive future growth. At the same time, we navigated increased competition in the PSMA PET landscape, which impacted PYLARIFY performance. We are taking actions to reinforce PYLARIFY’s clinical differentiation and support the value of our PSMA PET franchise,” said Brian Markison , CEO. “Today, we announced the FDA has accepted our NDA for a new PSMA PET formulation and the Board authorized a new $400 million stock repurchase program, which reflects our confidence in our long-term strategy to deliver value for our business, patients, and shareholders.” Summary Financial Results Second Quarter 2025 Sales of PYLARIFY were $250.6 million , a decrease of 8.3%. Sales of DEFINITY were $83.9 million , an increase of 7.5%. Operating income decreased 14.4% to $88.0 million . Adjusted operating income (non-GAAP) decreased 10.8% to $152.6 million . Fully diluted earnings per share increased 27.3% to $1.12 , compared to $0.88 in the prior year period. Adjusted fully diluted earnings per share (non-GAAP) decreased 12.8% to $1.57 , compared to $1.80 in the prior year period. Net cash provided by operating activities and free cash flow were $87.1 million and $79.1 million , respectively. Balance Sheet At June 30, 2025 , the Company's cash and cash equivalents were $695.6 million , after payment of $276.4 million for the Evergreen Theragnostics, Inc. (“Evergreen”) acquisition, which closed early in the second quarter of 2025, compared to $912.8 million at December 31, 2024 . The Company currently has access to up to $750.0 million from a revolving line of credit. Recent Business Highlights Business Development Updates In July, the Company announced the completion of the acquisition of Life Molecular Imaging, 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. Through the transaction, Lantheus acquired Neuraceq, a globally approved beta-amyloid targeted radiodiagnostic for Alzheimer’s disease, as well as an international commercial footprint and infrastructure. In June, the FDA approved an updated label for Neuraceq, expanding the clinical indication to include the use in both diagnostic assessment and identification of appropriate candidates for FDA-approved amyloid-targeting therapies. The expanded label also includes the utilization of quantitative amyloid plaque metrics in conjunction with visual image interpretation and broader use for monitoring of therapy and following progression to Alzheimer's disease. In May, the Company announced an agreement to sell its SPECT business to Illuminated Holdings, Inc. , the parent company of SHINE Technologies, LLC (“SHINE”). The transaction allows Lantheus to focus on growing its commercial portfolio of innovative PET radiodiagnostics and microbubbles, while advancing its pipeline of radiopharmaceuticals. The transaction is expected to close by the end of the year, subject to customary closing conditions. In April, the Company announced the completion of the acquisition of Evergreen, a clinical-stage radiopharmaceutical company based in New Jersey . Through the transaction, Lantheus acquired OCTEVY™, a registrational-stage PET imaging agent targeting neuroendocrine tumors, which complements Lantheus’ therapeutic candidate PNT2003, and also acquired a portfolio of clinical and pre-clinical theranostic pairs. The acquisition also advances Lantheus’ capabilities with the addition of Evergreen’s radioligand therapy manufacturing infrastructure, including a revenue-generating CDMO business. Radiopharmaceutical Pipeline Updates This morning, the Company announced FDA acceptance of a new drug application (“NDA”) for a new formulation of piflufolastat F 18 PSMA PET imaging agent. The new formulation will increase batch size by ~50%, which would allow Lantheus to serve significantly more patients while maintaining the same high standards that has made PYLARIFY the trusted choice for providers. In April, the Company announced that MK-6240, its next-generation tau imaging agent, met its primary endpoints in two pivotal clinical studies assessing the investigational asset’s sensitivity and specificity. The Company plans to submit an NDA to the FDA in the third quarter of 2025. Other Key Updates Full Year 2025 Updated Corporate Financial Guidance On a forward-looking basis, the Company does not provide GAAP income per common share guidance or a reconciliation of GAAP income per common share to adjusted fully diluted EPS because the Company is unable to predict with reasonable certainty business development and acquisition related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company’s view that a quantitative reconciliation of adjusted fully diluted EPS on a forward-looking basis is not available without unreasonable effort.   Conference Call and Webcast As previously announced, the Company will host a conference call and webcast on Wednesday, August 6, 2025 , at 8:00 a.m. ET . To access the conference call or webcast, participants should register online at https://investor.lantheus.com/news-events/calendar-of-events. A replay will be available approximately two hours after completion of the webcast and will be archived on the same web page for at least 30 days. The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com. The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release. 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 New Jersey , Canada , Germany , Sweden and Switzerland , Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. For more information, visit www.lantheus.com. Internet Posting of Information The Company routinely posts information that may be important to investors in the “Investors” section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company.  Non-GAAP Financial Measures The Company uses non-GAAP financial measures, such as adjusted net income and its line components; adjusted net income per share - fully diluted; adjusted operating income, and free cash flow. The Company’s management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Company’s operations, period over period. However, these measures may exclude items that may be highly variable, difficult to predict and of a size that could have a substantial impact on the Company’s reported results of operations for a particular period. Management uses these and other non-GAAP measures internally for evaluation of the performance of the business, including the evaluation of results relative to employee performance compensation targets. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP. 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. These forward-looking statements may be identified by their use of terms such as “advance,” “believe,” “continue,” “could,” “driving,” “expect,” “guidance,” “maintain,” “may,” “on track,” “plan,” “potential,” “predict,” “progress,” “should,” “target,” “will,” “would” and other similar terms. Such forward-looking statements include our guidance for the fiscal year 2025 and our plans to expand our portfolio of late-stage assets and high potential early-stage candidates, our acquisitions of Evergreen and Life Molecular and our plans to divest our SPECT business to SHINE, and 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 our actual results to materially differ from those described in the forward-looking statements include: (i) continued market expansion and penetration for our established commercial products, particularly PYLARIFY and DEFINITY, in a competitive environment and our ability to clinically and commercially differentiate our products; (ii) our ability to have third parties manufacture our products and our ability to manufacture DEFINITY in our in-house manufacturing facility, in amounts and at the times needed; (iii) the availability of raw materials, key components, and equipment, either used in the production of our products and product candidates, or in the use by healthcare professionals (“HCPs”) of our products and product candidates, including, but not limited to positron emission tomography (“PET”) scanners for PYLARIFY, MK-6240 and NAV-4694; (iv) our ability to satisfy our obligations under our existing clinical development partnerships using MK-6240 or NAV-4694 as a research tool and under the license agreements through which we have rights to MK-6240 and NAV-4694, and to further develop and commercialize MK-6240 and NAV-4694 as approved products, including the timing for any potential regulatory submissions for these investigational assets; (v) our ability to successfully integrate acquisitions, including of Life Molecular and Evergreen, including the potential for unforeseen expenses related to integration activities, the accuracy of our financial models, the potential for unforeseen liabilities within those businesses, the ability to integrate disparate information technology systems, retain key talent and create a merged corporate culture that successfully realizes the full potential of the combined organization; (vi) our ability to obtain U.S. Food and Drug Administration ("FDA") approval for our new F-18 PSMA PET product candidate, to complete the technology transfer across our PET manufacturing facilities network for such new product candidate, and to obtain adequate coding, coverage and payment, including transitional pass-through payment status, for such new product candidate; (vii) our ability to complete the sale of our single-photon emission computerized tomography ("SPECT") business to SHINE on the proposed terms or on the anticipated timeline, or at all, including risks and uncertainties related to securing the necessary regulatory approvals and satisfaction of other closing conditions to consummate the transaction, unforeseen expenses related to the divestiture, and failure to realize the expected benefits of the transaction; (viii) our ability to obtain FDA approval for LNTH-2501, our investigational kit for the preparation of Gallium-68 DOTATOC, which may be used in conjunction with a PET scan to stage and localize gastroenteropancreatic neuroendocrine tumors in adults and children, and approval for PNT2003, and to be successful in the patent litigation associated with PNT2003; (ix) the cost, efforts and timing for clinical development, regulatory approval, adequate coding, coverage and payment and successful commercialization of our product candidates and new clinical applications and territories for our products, in each case, that we or our strategic partners may undertake; (x) our ability to identify opportunities to collaborate with strategic partners and to acquire or in-license additional diagnostic and therapeutic product opportunities in oncology, neurology and other strategic areas and continue to grow and advance our pipeline of products; and (xi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q). - Tables Follow - (a) Non-GAAP amount excludes a gain of $42 from the change in value of other assets for the three and six months ended June 30, 2025 . (b) The income tax effect of the adjustments between GAAP net income and adjusted net income (non-GAAP) takes into account the tax treatment and related tax rate that apply to each adjustment in the applicable tax jurisdiction. (c) Amounts may not add due to rounding. Contacts: Mark Kinarney Vice President, Investor Relations978-671-8842ir@lantheus.com Melissa Downs Executive Director, External Communications 646-975-2533media@lantheus.com Source: Lantheus Holdings, Inc.

Highlights Topline data from Clarity's diagnostic Phase II trial, SABRE, showed that 64Cu-SAR-Bombesin was safe, well tolerated and effective at detecting prostate cancer in patients with biochemical recurrence (BCR) who are negative or equivocal on standard-of-care (SOC) scans, including prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET). SAR-Bombesin targets the gastrin-releasing peptide receptor (GRPR), a promising pan-cancer target expressed in a number of indications, including prostate cancer. Unlike PSMA-targeted agents, 64Cu-SAR-Bombesin may be particularly valuable for imaging prostate cancer with known biological heterogeneity, which prostate cancer is known to be. The trial enrolled 53 patients. 64Cu-SAR-Bombesin identified lesions in approximately 35% and 28% of participants on same-day and next-day imaging, respectively (average across readers). Forty-nine lesions in total were identified on 64Cu-SAR-Bombesin PET/computed tomography (CT) scans (average across readers and imaging days). The participant-level correct detection rate (CDR) was 14.9% (95% confidence interval [CI]: 6.2, 28.3) on same-day imaging and ranged from 4.3% to 14.9% (95% CI: 0.5-28.3) on next-day imaging across the readers. Region-level positive predictive value (PPV) ranged from 22.6% to 47.1% (95% CI: 9.6-72.2) on same-day imaging and from 22.2% to 37.5% (95% CI: 2.8-61.7) on next-day imaging. The CDR and PPV results were substantially impacted by the large number of lesions that were detected, but unable to be verified by biopsies (not clinically feasible in many cases) and by the low sensitivity of follow-up SOC imaging. Despite biopsy not being SOC for this patient population, approximately 16% of patients who were positive on 64Cu-SAR-Bombesin PET/CT were biopsied in the SABRE study. All lesions assessed by histopathology were positive for prostate cancer, indicating a 100% true-positive rate among those biopsied lesions. As an example, in one participant, 64Cu-SAR-Bombesin PET/CT detected multiple lesions, two of which were confirmed as prostate cancer by biopsy. No lesions were detected on a prior SOC screening 18F-DCFPyL PSMA PET/CT scan, and on a follow-up 18F-DCFPyL PET/CT scan conducted approximately 11 weeks later only one bone lesion was detected. A follow-up CT scan conducted approximately 3 months after the 64Cu-SAR-Bombesin scans confirmed the presence of multiple cancerous lesions. Only two participants had adverse events (AEs) related to 64Cu-SAR-Bombesin, with all being mild (Grade 1) and resolving within 2 days of onset. Based on these positive results, Clarity has commenced discussions with key medical experts to determine the most effective pathway for registration of 64Cu-SAR-Bombesin and to explore its development in a range of large oncology indications with high unmet needs. SYDNEY, June 13, 2025 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce positive topline results from the diagnostic Phase II SABRE trial (NCT05407311)[1] with 64Cu-SAR-Bombesin in participants with PSMA-negative BCR of prostate cancer following definitive therapy. SAR-Bombesin targets the GRPR present on cells of a range of cancers, including prostate cancer. SABRE trial design Continue Reading Figure 1. Detection of extensive metastatic disease by 64Cu-SAR-Bombesin in a participant with BCR of prostate cancer. The initial 18F-DCFPyL PSMA PET at screening was negative (left image), whereas same-day imaging with 64Cu-SAR-Bombesin (middle image) detected widespread disease, including lesions in the right pelvic bone and a supradiaphragmatic LN, which were confirmed as prostate cancer by biopsy. A follow-up 18F-DCFPyL scan approximately 11 weeks later (right image) was still unable to detect the extensive recurrence identified by the 64Cu-SAR-Bombesin scan. Maximum intensity projection of PET imaging. Images are shown with consistent scaling for visual comparison. SABRE (Copper-64 SAR-Bombesin in Biochemical Recurrence of prostate cancer) was a Phase II multi-centre, single arm, non-randomised, open-label copper-64 labelled SAR-Bombesin PET imaging trial of patients with PSMA-negative BCR of prostate cancer following definitive therapy. To be considered for inclusion in the study, candidates were required to demonstrate negative or equivocal findings for prostate cancer on approved PSMA PET (68Ga-PSMA-11 or 18F-DCFPyL), anatomical imaging (CT and/or magnetic resonance imaging [MRI]) and any other SOC imaging, if available. The primary objectives of the trial were to investigate the safety and tolerability of the product as well as its ability to correctly detect recurrence of prostate cancer. Study participants were dosed with 200 MBq of 64Cu-SAR-Bombesin and underwent PET/CT scans at 1-4 hours and 24 ± 6 hours post-dose (same-day and next-day imaging, respectively). The scans were interpreted by three blinded central readers. To determine the efficacy of 64Cu-SAR-Bombesin imaging, the same-day and next-day PET/CT results of the central readers were assessed against a composite reference standard that was determined by an independent, blinded, central expert panel. The reference standard consisted of histopathology, follow-up SOC imaging and/or confirmed prostate-specific antigen (PSA) response to focal therapy. The primary efficacy endpoints were participant-level CDR (defined as the proportion of true-positive participants out of all scanned participants who had at least one evaluable reference standard datapoint collected) and region-level PPV (defined as the proportion of true-positive regions out of all positive regions on the 64Cu-SAR-Bombesin PET/CT scan with corresponding evaluable composite reference standard data), assessed independently for same-day and next-day imaging timepoints. The design of the SABRE study followed advice from regulators to achieve the highest standards in clinical research in the BCR setting. Based on this guidance, the expert panel, who determined the reference standard, was blinded to the results of the 64Cu-SAR-Bombesin scans and distinct from the central readers assessing the 64Cu-SAR-Bombesin scans. This approach removed potential biases in the assessment of the reference standard, which was not the case for other studies conducted in this setting. The SABRE study design also adopted a conservative approach to the analysis of both co-primary endpoints. If a lesion identified on the 64Cu-SAR-Bombesin scan was not biopsied, and it was also not present on follow-up SOC imaging (a suboptimal reference standard with known low sensitivity and in a patient population that was negative on SOC imaging at screening), it was considered as false-positive in the analysis by default. Topline results Fifty-three patients with negative or equivocal SOC scans at screening (which included approved PSMA PET and anatomical imaging) were enrolled and imaged. Forty-seven participants were evaluable for the primary efficacy endpoints. Approximately half of the participants enrolled had PSA less than or equal to 1.0 ng/mL at study entry. The average detection rate across readers using 64Cu-SAR-Bombesin PET/CT was 35.2% on same-day imaging (24.5%-43.4% range) and 27.7% on next-day imaging (17%-37.7% range). Approximately 47 lesions were identified on same-day imaging (40-59 range) and approximately 52 on next-day imaging (24-95 range), despite these patients having negative or equivocal SOC scans prior to study entry, highlighting the potential clinical benefit that imaging with 64Cu-SAR-Bombesin can provide. The most common site of lesion detection was in the lymph nodes (LNs) and the prostate regions. The participant-level CDR was 14.9% (95% CI: 6.2, 28.3) on same-day imaging and ranged from 4.3% to 14.9% (95% CI: 0.5-28.3) on next-day imaging across the readers. Region-level PPV ranged from 22.6% to 47.1% (95% CI: 9.6-72.2) on same-day imaging and from 22.2% to 37.5% (95% CI: 2.8-61.7) on next-day imaging. The CDR and PPV results were substantially impacted by the large number of lesions that were detected on the 64Cu-SAR-Bombesin scans, but unable to be verified due to the lack of effective diagnostic options available for comparison and biopsy not being clinically appropriate in most cases. Three patients underwent biopsy (the 'gold standard' for verifying lesions) due to the findings of the 64Cu-SAR-Bombesin scan and a total of four biopsies were performed. All biopsies were positive for prostate cancer, including two pelvic LNs, one extra-pelvic LN and one bone lesion. Administration of 64Cu-SAR-Bombesin at 200 MBq was shown to be safe and well tolerated. Only two participants had AEs related to 64Cu-SAR-Bombesin with all being mild (Grade 1) and resolving within 2 days of onset. Case study A participant with BCR of prostate cancer presented with a baseline PSA of 22.3 ng/mL, negative SOC PSMA PET (18F-DCFPyL, Figure 1, left image) and equivocal CT at screening. Imaging with 64Cu-SAR-Bombesin (middle image) revealed substantial disease burden with lesions detected in the pelvic LNs, extra-pelvic LNs, visceral/soft tissue, and bone. Subsequent biopsies of a right pelvic bone lesion and a supradiaphragmatic LN confirmed malignancy at both sites. A follow-up 18F-DCFPyL PET scan, conducted approximately 4 months after the screening with 18F-DCFPyL, failed to detect lesions in all regions except for the bone. Clarity's Executive Chairperson, Dr Alan Taylor, commented, "The SABRE trial represents an important milestone for Clarity, setting a new benchmark by seeking to identify lesions that do not express PSMA. This trial, which is Clarity's first sponsored study with 64Cu-SAR-Bombesin, has now shown that this product can provide a solution where the current diagnostic options fall short and improve lesion detection beyond what is achievable with SOC PSMA-targeted imaging. Prostate cancer is characterised by significant biological heterogeneity, where some patients, or even individual lesions within the same patient, may lack PSMA expression and remain undetectable on PSMA-targeted imaging. A PET agent targeting an alternative receptor, such as GRPR, which is expressed in up to 100% of prostate cancers[2-6], may allow for better staging and hence more accurate treatment of BCR prostate cancer. As seen in the SABRE trial, some patients have widespread metastatic disease that remains completely undetectable by all available SOC imaging for extended periods. These patients deserve access to advanced diagnostic tools, such as 64Cu-SAR-Bombesin PET, that can reveal otherwise hidden disease and open the door to more informed and effective treatment options. "We are very pleased with these results of the SABRE trial as a first look into this extraordinary patient population that has virtually invisible disease using SOC imaging and therefore, by definition, a very high unmet medical need. The data confirms that 64Cu-SAR-Bombesin is safe, well tolerated, and effective at detecting prostate cancer recurrence. Up to approximately 43% of participants had a positive 64Cu-SAR-Bombesin PET/CT, demonstrating the potential scale of the diagnostic gap this novel agent may help address with no disease identified by SOC imaging. These results are also corroborated by the findings of an earlier investigator-initiated trial (IIT), BOP, conducted by Prof Louise Emmett at St Vincents Hospital Sydney, where 64Cu-SAR-Bombesin PET/CT identified disease recurrence in 44% of participants with BCR of prostate cancer and negative or equivocal 68Ga-PSMA-11 PET/CT[7]. "The lack of any suitable diagnostic options for these men is made clear by the difficulty faced in validating lesions detected by 64Cu-SAR-Bombesin. Given we identified a large number of lesions with our product, it was not feasible nor ethical to verify all lesions with biopsy. Verification of the findings by other means, such as SOC imaging, was further complicated by the very nature of the trial, which specifically enrolled patients who were negative or equivocal on all available SOC imaging. These inherent challenges led to a high number of lesions not being confirmed as true-positives in the study. However, the fact that prostate cancer was confirmed in all 64Cu-SAR-Bombesin PET-positive lesions that were biopsied strongly reinforces the potential clinical value of this agent and the need it may fulfill within the current diagnostic landscape. SABRE has provided valuable insights into the performance of 64Cu-SAR-Bombesin relative to available SOC imaging. The study findings, including the potential for significantly improved lesion detection, will be carefully considered in the design of a registrational trial. "We now have three exceptional diagnostic agents in various stages of clinical development, 64Cu-SAR-bisPSMA, 64Cu-SARTATE and 64Cu-SAR-Bombesin, and all three are showing impressive efficacy compared to SOC imaging. We look forward to sharing additional data readouts from all trials and progressing discussions with key medical experts to determine the most effective pathway for registration, particularly with this asset, 64Cu-SAR-Bombesin, as the pathway to commercialisation for 64Cu-SAR-bisPSMA and 64Cu-SARTATE is clearly defined and quickly progressing. We have already explored additional indications expressing GRPR with high unmet needs where 64Cu-SAR-Bombesin may significantly improve the diagnostic landscape, and we have seen some promising data on the benefits of 64Cu-SAR-Bombesin PET/CT in breast cancer patients from the C-BOBCAT IIT, also conducted by Professor Louise Emmett. Results from this study showed high lesion uptake of 64Cu-SAR-Bombesin in women with lobular subtype of metastatic breast cancer in comparison to SOC imaging (i.e. CT, bone scan and 18F-FDG PET/CT), indicating that our imaging agent could offer improved diagnostic options in this indication[8]. "These encouraging findings from the SABRE, BOP and C-BOBCAT trials, as well as other trials with GRPR-targeted agents in other cancers, highlight the broad potential of 64Cu-SAR-Bombesin to become a best-in-class diagnostic agent in a number of indications. This reinforces our drive to advance Targeted Copper Theranostics in areas of significant clinical need, as these areas lack not only accurate diagnostics, but also effective therapeutics. The detection of GRPR-expressing cancers could represent a significant opportunity to enable more comprehensive disease assessment across varied tumour phenotypes. We look forward to working with key regulatory groups, such as the US Food and Drug Administration (FDA), to explore various avenues and indications with SAR-Bombesin further as we continually strive to improve diagnostic and theranostic options for patients and their clinicians." About SAR-Bombesin 64Cu-SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the GRPR present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPR is found in up to 100% of prostate cancers, including prostate cancers that don't express PSMA (PSMA-negative)[2-6]. The product utilises Clarity's proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy. Disclaimer 64Cu-SAR-Bombesin is an unregistered product. The safety and efficacy of 64Cu-SAR-Bombesin has not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available. About Prostate Cancer Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide[9]. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease[10]. Approximately 20-25% of prostate cancer patients with BCR have low or no uptake of PSMA-targeting tracer[11-14]. These patients are unlikely to show meaningful uptake of PSMA-targeted products, such as 68Ga-PSMA-11. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment. About Clarity Pharmaceuticals Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers. References ClinicalTrials.gov Identifier: NCT05407311, Markwalder R, Reubi JC. Gastrin-releasing peptide receptors in the human prostate: relation to neoplastic transformation. Cancer research. 1999;59(5):1152-1159. Fleischmann A, Waser B, Reubi JC. High expression of gastrin-releasing peptide receptors in the vascular bed of urinary tract cancers: promising candidates for vascular targeting applications. Endocrine-related cancer. 2009;16(2):623-633. Ananias HJ, van den Heuvel MC, Helfrich W, de Jong IJ. Expression of the gastrin-releasing peptide receptor, the prostate stem cell antigen and the prostate-specific membrane antigen in lymph node and bone metastases of prostate cancer. The Prostate. 2009;69(10):1101-1108. Reubi JC, Wenger S, Schmuckli-Maurer J, Schaer JC, Gugger M. Bombesin receptor subtypes in human cancers: detection with the universal radioligand (125)I-[D-TYR(6), beta-ALA(11), PHE(13), NLE(14)] bombesin(6-14). Clin Cancer Res. 2002;8(4):1139-1146. Sun B, Halmos G, Schally AV, Wang X, Martinez M. Presence of receptors for bombesin/gastrin-releasing peptide and mRNA for three receptor subtypes in human prostate cancers. The Prostate. 2000;42(4):295-303. Li S et al. Utility of 64Cu-Sarcophagine-Bombesin PET/CT in Men with Biochemically Recurrent Prostate Cancer and Negative or Equivocal Findings on 68Ga-PSMA-11 PET/CT. J Nucl Med. 2024 Sep 3;65(9):1371-1375. doi: 10.2967/jnumed.124.267881. Wong K, Sheehan-Dare G, Nguyen A, Ho B, Liu V, Lee J, Brown L, Dear R, Chan L, Sharma S, Malaroda A, Smith I, Lim E, Emmett L. 64Cu-SAR-Bombesin PET-CT Imaging in the Staging of Estrogen/Progesterone Receptor Positive, HER2 Negative Metastatic Breast Cancer Patients: Safety, Dosimetry and Feasibility in a Phase I Trial. Pharmaceuticals (Basel). 2022 Jun 22;15(7):772. doi: 10.3390/ph15070772. PMID: 35890071; PMCID: PMC9316435. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, American Cancer Society: Key Statistics for Prostate Cancer, Afshar-Oromieh A, Holland-Letz T, Giesel FL, et al. Diagnostic performance of 68Ga-PSMA-11 (HBED-CC) PET/CT in patients with recurrent prostate cancer: evaluation in 1007 patients. Eur J Nucl Med Mol Imaging. 2017 Aug;44(8):1258-1268. Ferraro DA, Rüschoff JH, Muehlematter UJ, et al. Immunohistochemical PSMA expression patterns of primary prostate cancer tissue are associated with the detection rate of biochemical recurrence with 68Ga-PSMA-11 PET. Theranostics. 2020;10(14):6082-6094. Baratto L, Song H, Duan H, et al. PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2021;62(11):1545-1549. Mapelli P, Ghezzo S, Samanes Gajate AM, et al. 68Ga-PSMA and 68Ga-DOTA-RM2 PET/MRI in Recurrent Prostate Cancer: Diagnostic Performance and Association with Clinical and Histopathological Data. Cancers (Basel). 2022;14(2):334. This announcement has been authorised for release by the Executive Chairperson. SOURCE Clarity Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED