BiomX CEO Jonathan Solomon to Present at Biomed Israel 2025 Conference
NESS ZIONA, Israel, May 19, 2025 (GLOBE NEWSWIRE) — BiomX Inc. (NYSE American: PHGE) ('BiomX' or the 'Company'), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that Jonathan Solomon, Chief Executive Officer, will present at the Biomed Israel 2025 conference, reviewing the Company's topline Phase 2 results for BX211 in DFO. The conference is being held between May 20 – 22, 2025, in Tel Aviv, Israel.
Presentation Details Oral Presentation Title Precision Phage Therapy for Chronic Diabetic Foot Infections Session Immunology & Inflammation; Reclaim Top Priorities in BioPharma: Driver and Opportunities? Session Time/Location: May 21, 2025, 12:15 – 2:15 pm IST, Hall A, InterContinental David Tel Aviv
'Leading the innovation of phage therapies, BiomX's programs target persistent, antibiotic-resistant infections in chronic diseases that can result in devastating impacts, including substantially increased morbidity and mortality, for patients,' said Jonathan Solomon, Chief Executive Officer of BiomX. 'At Biomed Israel, the premier biopharma conference in the region, we have the opportunity to showcase the positive topline Phase 2 results for our BX211 program in DFO associated with Staphylococcus aureus . We are grateful for key opinion leader endorsements we've received and to the organizations that have provided vital support for this program, and we look forward to presenting our BX211 Phase 2 findings at an upcoming, peer-reviewed scientific forum.'
BX211 Topline Phase 2 Trial Results Available: Here
About BX211
BX211 is a phage treatment for the treatment of DFO associated with S. aureus . DFO is a bacterial infection of the bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. In March 2025, BiomX announced positive topline results from the Phase 2 trial in which BX211 was demonstrated to be safe and well-tolerated and patients receiving BX211 exhibited statistically significant1 and sustained reduction of ulcer size (PAR)(p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo starting at week 7 and a difference greater than 40% by week 10. In addition, BX211 also produced statistically significant1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline, ulcer depth was classified according to deepest tissue involved as measured by swab) (p=0.048), and in reducing the expansion of ulcer area (p=0.017). Over the 12-week treatment period, all patients (treatment and placebo) were treated in accordance with standard of care, including with systemic antibiotic therapy as appropriate. BiomX is currently planning a Phase 2/3 trial, pending discussions and feedback from the Food and Drug Administration ('FDA').
About BiomX
BiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT ('BacteriOphage Lead to Treatment') platform to customize phage compositions against these targets. For more information, please visit www.biomx.com, the content of which does not form a part of this press release.
Safe Harbor
This press release contains express or implied 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'target,' 'believe,' 'expect,' 'will,' 'may,' 'anticipate,' 'estimate,' 'would,' 'positioned,' 'future,' and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. For example, when BiomX refers to its anticipated timing of its future clinical trials as well as the design thereof, expected discussions with the FDA and other regulatory authorities and results thereof, and the potential of its candidates to address the substantial unmet needs of patients with intractable infections, it is using forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on BiomX management's current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of BiomX's control. These risks and uncertainties include, but are not limited to, changes in applicable laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in BiomX's drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, BiomX's ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA and other regulatory authorities; decisions made by investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; BiomX's ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; its potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX's cash resources to fund its planned activities for the periods anticipated and BiomX's ability to manage unplanned cash requirements; and general economic and market conditions. Therefore, investors should not rely on any of these forward-looking statements and should review the risks and uncertainties described under the caption 'Risk Factors' in BiomX's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the 'SEC') on March 25, 2025, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC's website at www.sec.gov. Forward-looking statements are made as of the date of this press release, and except as provided by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements.
Contacts:
BiomX, Inc.Ben CohenHead Corporate Communications
[email protected]
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Immune Mediated Myelitis: Grade 3 myelitis occurred 25 days following treatment with CARVYKTI® in CARTITUDE-4 in a patient who received CARVYKTI® as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause. Peripheral Neuropathy occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade ≥3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days). Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients including those with ongoing neurologic events at the time of death or data cut-off. Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS. Cranial Nerve Palsies occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade ≥3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days). Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients including those with ongoing neurologic events at the time of death or data cut-off. Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4). The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected. Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms. HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)/MACROPHAGE ACTIVATION SYNDROME (MAS): Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI®, with a median onset of 10 days (range: 8 to 99 days) and all occurred in the setting of ongoing or worsening CRS. The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multi-organ dysfunction, including renal dysfunction and respiratory failure. Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI®. HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards. CARVYKTI® REMS: Because of the risk of CRS and neurologic toxicities, CARVYKTI® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI® REMS. Further information is available at or 1-844-672-0067. PROLONGED AND RECURRENT CYTOPENIAS: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI® infusion. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, Grade 3 or higher cytopenias not resolved by day 30 following CARVYKTI® infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285) and anemia 2% (6/285). After Day 60 following CARVYKTI® infusion 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia. Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death. Monitor blood counts prior to and after CARVYKTI® infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines. INFECTIONS: CARVYKTI® should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections, occurred in patients after CARVYKTI® infusion. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, infections occurred in 57% (163/285), including ≥Grade 3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI® had an increased rate of fatal COVID-19 infections compared to the standard therapy arm. Monitor patients for signs and symptoms of infection before and after CARVYKTI® infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI® infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19. Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), human immunodeficiency virus (HIV), or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice. HYPOGAMMAGLOBULINEMIA: can occur in patients receiving treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500mg/dl after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500mg/dl, after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI® for either an adverse reaction or prophylaxis. Monitor immunoglobulin levels after treatment with CARVYKTI® and administer IVIG for IgG <400 mg/dL. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis. Use of Live Vaccines: The safety of immunization with live viral vaccines during or following CARVYKTI® treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI® treatment, and until immune recovery following treatment with CARVYKTI®. HYPERSENSITIVITY REACTIONS occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were ≤ Grade 2. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia. Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI®. Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction. SECONDARY MALIGNANCIES: Patients treated with CARVYKTI® may develop secondary malignancies. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI®. Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post-marketing setting. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusions and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc. at 1-800-526-7736 for reporting and to obtain instructions on collection of patient samples. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status, seizures, neurocognitive decline, or neuropathy, patients receiving CARVYKTI® are at risk for altered or decreased consciousness or coordination in the 8 weeks following CARVYKTI® infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery during this initial period, and in the event of new onset of any neurologic REACTIONS The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia. Please read full Prescribing Information, including Boxed Warning, for CARVYKTI®. ABOUT CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL) Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient's own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.1 In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company, to develop and commercialize cilta-cel. In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma. In April 2024, cilta-cel was approved for the second-line treatment of patients with relapsed/refractory myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide. In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma. In September 2022, Japan's Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI®. Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency's Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment. ABOUT CARTITUDE-1 CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a PI and IMiD, received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy. The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.2 ABOUT CARTITUDE-4 CARTITUDE-4 (NCT04181827) is an ongoing, international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a PI and an IMiD.3 ABOUT LB1908 NCT05539430 is a Phase 1, open label, dose escalation, multicenter study to evaluate Claudin 18.2-targeting CAR-T cells (LB1908) in adult patients with unresectable, locally advanced or metastatic gastric, gastroesophageal junction, esophageal, or pancreatic adenocarcinoma.4 ABOUT LB2102 NCT05680922 is a Phase 1, first-in-human, open-label, multicenter, dose escalation and expansion study of DLL3-targeted chimeric antigen receptor T-cells (LB2102) in patients with extensive stage small cell lung cancer or large cell neuroendocrine lung cancer.5 ABOUT MULTIPLE MYELOMA Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.6 In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.7 While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.8 ABOUT GASTRIC, ESOPHAGEAL AND PANCREATIC CANCERS Stomach, esophageal and pancreatic cancers affect the tissue or glands lining these organs. They are often diagnosed when the diseases have progressed to advanced stages. In the U.S., there are an estimated 123,920 people living with stomach cancer and 49,084 living with esophageal cancers.9,10 An estimated 89,248 people in the U.S. live with pancreatic cancer. While all three cancers are treatable, the five-year survival rate is just 32% for gastric cancer; 20% for esophageal cancer; and 11.5% for pancreatic cancer, with definitive treatment at all stages of progression.11,12,13 ABOUT SMALL CELL LUNG CANCER Lung cancer is a leading cause of cancer deaths, contributing to 25 percent of all cancer-related fatalities annually in the United States.14 Small cell lung cancer (SCLC) is the most aggressive, and accounts for roughly 10-15 percent of lung cancer cases in the United States.15,16 An estimated 30,000 to 35,000 people are newly diagnosed with the disease each year.16 This cancer becomes more difficult to treat once it has spread and becomes extensive stage SCLC. Approximately 60 to 70 percent of SCLC patients are diagnosed with metastatic SCLC.15,17 ABOUT LEGEND BIOTECH With over 2,600 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. The company is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the US, Legend is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI's patient access and therapeutic potential. From this platform, the company plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities. Learn more at and follow us on X (formerly Twitter) and LinkedIn. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute 'forward-looking statements' within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech's strategies and objectives; statements relating to CARVYKTI®, including Legend Biotech's expectations for CARVYKTI® and its therapeutic potential; statements related to the potential results from ongoing studies in the CARTITUDE clinical development program; and the potential benefits of Legend Biotech's product candidates. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech's expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech's patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the 'Risk Factors' section of Legend Biotech's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 11, 2025. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. ‡ Sundar Jagannath, M.D., Network Director, Multiple Myeloma Center of Excellence for Multiple Myeloma at The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, has provided consulting, advisory, and speaking services to Legend Biotech; has not been paid for any media work. INVESTOR CONTACT: Jessie YeungTel: (732) 956-8271 PRESS CONTACT: MaryAnn OndishTel: (914) 552-4625media@ REFERENCES _____________________ 1 CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.2 A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1). Available at: Accessed October 2022.3 A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). Accessed March 2024.4 Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma. Available at: Accessed May 20255 DLL3-Directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer. Available at: Accessed May 20256 American Cancer Society. 'What is Multiple Myeloma?'. Available at: Accessed March 2024.7 American Cancer Society. 'Key Statistics About Multiple Myeloma.' Available at: Accessed March 20248 American Cancer Society. Multiple myeloma: early detection, diagnosis, and staging. Available at: Accessed March 2023.9 Surveillance, Epidemiology, and End Results (SEER) Program. Accessed May 2022.10 Surveillance, Epidemiology, and End Results (SEER) Program. Accessed May 2022.11 American Cancer Society. Accessed May 2022.12 American Cancer Society. May 2022.13 Surveillance, Epidemiology, and End Results (SEER) Program. Accessed May 2022.14 American Cancer Society. 'Key Statistics for Lung Cancer.' Accessed November 2022.15 Byers LA, Rudin CM. Small cell lung cancer: where do we go from here? Cancer. 2015;121(5):664-72.16 Rare Diseases. 'Rare Disease Database.' Accessed November 2022.17 Gong J, Salgia R. Managing patients with relapsed small-cell lung cancer. J Oncol Pract. 2018;14(6): in to access your portfolio
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Critical Metals Corp Releases Additional High-Grade REE Results From Diamond Drilling at Tanbreez in Greenland
NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- Critical Metals Corp. (Nasdaq: CRML) ('Critical Metals Corp' or the 'Company'), a leading critical minerals mining company, is pleased to publish for the first time the assay results of eleven deep diamond drill holes from the Tanbreez Project in Greenland drilled in 2007 and 2013 at the Fjord Deposit. Commenting on the assay results, Tony Sage, CEO and Executive Chairman of the Company, said: "I am further encouraged by the deep diamond drill hole results at Tanbreez, revealing exceptional assay results over wider and deeper mineralization. Tanbreez continues to yield consistent high-grade drilling results presenting the Company with a compelling opportunity to significantly increase and double our current Maiden Resource Estimate (MRE) with an exploration target of 500MT of rare earth material up from our previous target of 225MT.' 'This key technical work to uncover and update historical information, strategically positions us to advance our plans for the development strategy as we deepen our understanding of the potential of this world-class asset and the material it contains. Our exploration and in-country field crews are currently on the ground at Tanbreez organizing the forthcoming field season preparing for resource and exploration drilling. After recently announcing the MRE of ~45MT 0.38% TREO for the eudialyte component and 180 MT for the industrial mineral by-products of feldspar and arfvedsonite, together with previously announced robust economic results showing the NPV of US$2.4 ~US$3.0 billion on a 10% and 8% discount and an IRR of 180% before tax.' The Tanbreez Project is operated by Tanbreez Mining Greenland A/S and is currently under the ownership of Critical Metals Corp. (NASDAQ: CRML) (Critical Metals or CRML), which currently holds a 42% interest with the right to increase that to 92.5% interest, with European Lithium holding a 7.5% interest and Rimbal Pty Ltd a 50.5% interest. Next Steps The Company has applied to the Greenland MSLA for a Program of Works for the 2025 resource drilling programs aimed at upgrading the Inferred Resource to Indicated Resource category and extending the size of the Tanbreez Fjord and Hill Zone Deposits (See figure 7). The applications with Greenland authorities are well-advanced and the Company is preparing for the 2025 field season with drilling and exploration executives visiting the deposit from 30 May. The Company is currently re-assaying historical pulps stored in Perth and Greenland from some of the existing 2007, 2010, 2013 and 2024 drill, rock chip and bulk sampling for confirmation and check assay reconciliation. The pulp will be analyzed by ALS Metallurgical Laboratory in Perth Western Australia and the results will be published when they become available. Further updated historical assay results are expected soon. The first stage of the priority resource drilling program will target the Fjord Deposit containing the 23MT MRE footprint by extending drilling further to the north and east of the 16-diamond hole program from 2024. The average target depth will be 60m – 80m drilling through the mineralized kakortokite bearing REE and metal oxides and 5m into the basal unit sanitizing mineralisation from the uneconomic grade 'Black Madonna' unit. Critical Metals Corp will commence its 2025 drilling campaign following satisfactory drill results from the 2024 program with the remaining 15 holes assay. The Company expects to announce the results from the 2024 campaign shortly. . The second stage of the priority resource drilling program will target the Hill Zone Deposit containing 22.6MT MRE area by infilling drill lines between D306 -13 and DX-01 and DX-02 and DX-01 on the east to west margins over the current MRE footprint. The target depth will be limited to 150m, targeting continuous mineralisation to defined depth establishing a re-categorization of Inferred to Indicated Resource upgrade. The Company continues to evaluate all available data from the previous owner's database and will publish results upon third party and in-house consultation. Highlights – Newly Released Diamond Drill Hole Results The weighted average grade1- 0.43% TREO with 28% HREO plus 1.44% ZrO2. _____________________________ 1 Weighted average grade estimated: SUM (interval x grade) divided by SUM (interval) Diamond Drill Hole Interval metresGrade (TREO) % Grade (HREO) % Grade (ZrO2) DDH-07-06 47.65m at 0.38% TREO 28% HREO 1.35% ZrO2 DDH-07-07 99.33m at 0.43% TREO 28% HREO 1.50%ZrO2 DDH-07-08 118.37m at 0.49% TREO 29% HREO 1.79% ZrO2 DDH-07-09 72.96m at 0.51% TREO 29% HREO 1.90% ZrO2 DDH-07-10 133.61m at 0.41% TREO 28% HREO 1.54% ZrO2 DDH-07-11 247.75m at 0.33% TREO 27% HREO 0.82% ZrO2 DDH-07-12 76.50m at 0.41% TREO 29% HREO 1.40% ZrO2 DDH-07-13 79.12m at 0.46% TREO 27% HREO 1.23% ZrO2 DDH-07-14 240.89m at 0.48% TREO 29% HREO 1.57% ZrO2 DDH 13-011 60.50m at 0.49% TREO 27% HREO 1.93% ZrO2 DDH 13-016 38.95m at 0.49% TREO 28% HREO 1.93% ZrO2 Figure 1 – 30 May 2025 site inspection Fjord deposit drill hole collars DDH-07-06 to DDH-07-10. Mr Greg Barnes (Tanbreez Mining Greenland A/S), & Mr George Karageorge Company Chief Technical Officer. Highlights – Recently Released Diamond Drill Hole Results Today's announcement reports assay results confirming deep and highly mineralized TREO for each drill hole ranging from 0.33% to 0.51% with a weighted average of 0.43% TREO containing 28% HREO hosted within the vast Kakortokite rock and over the Fjord Deposit for the eudialyte component MRE of 22.6MT 0.43% TREO including 26% HREO (See Table 1).Table 1 - Recent Drill Hole Results (announced 18 March 2025, 28 March 2025, 12 May 2025 and 9 June 2025) – holes DDH-07-06 to DDH-07-10 were drilled from the same collar location BDL = Below Detection Limit NA = Not Assayed New Drill Hole Results Locations within the Fjord Deposit Area Today's announcement publishes new results for drill holes drilled through the Fjord deposit and extended below the Mineral Resource Estimate (MRE) for the Fjord deposit (see Nasdaq Press Release 13 March and 29 May 2025). The MRE assessed the eudialyte component of the kakortokite limited to the material above sea level. The deeper drill holes identified rare earth mineralisation at similar grades within the kakortokite unit below and within the MRE. Hole ID Easting Northing Elevation Dip Azimuth Total Depth DDH-07-06 452770 6748174 62 -45 232 99 DDH-07-07 452770 6748174 62 -60 232 111 DDH-07-08 452770 6748174 62 -45 322 171 DDH-07-09 452770 6748174 62 -45 52 168 DDH-07-10 452770 6748174 62 -45 142 150 DDH-07-11 452810 6748417 25 -80 160 249 DDH-07-12 452899 6748332 77 -90 0 78 DDH-07-13 453160 6747889 326 -45 200 85.2 DDH-07-14 453160 6747889 326 -60 290 243 DDH 13-011 452789 6748314 41 -90 -90 62 DDH 13-016 452840 6748225 64 -90 -90 68 Table 2 – New drill hole locations These drill holes drilled through the Fjord deposit and extended below the Mineral Resource Estimate for the Fjord deposit (see Nasdaq Press Release 17 March, 31 March and 19 May 2025). The MRE assessed the eudialyte component of the kakortokite limited to the material above sea level. The deeper drill holes identified rare earth mineralisation at similar grades within the kakortokite unit below the MRE. Deep Drill Hole Results The new deep hole results announced today present a compelling opportunity for the Company to increase the existing MRE over the Tanbreez Fjord Deposit with infill and extension drilling between all historical diamond and RC drill holes (see Nasdaq Press Release 17 March, 31 March and 19 May 2025). The MRE assessed the eudialyte component of the kakortokite limited to the material ). DDH-007-06, DDH-007-07, DDH-007-08, DDH-007-09, DDH-007-010, were drilled from the same location as a fan of holes into the kakortokite above sea level (except DDH-007-08 and DDH-007-10). DDH-007-12 was drilled between the fan of holes and the fjord coastline down to sea level and DDH-007-11 drilled to 21m below sea level. These holes were included in the MRE. DDH-007-08 and DDH-007-011 drilled below sea level. These holes confirmed the extension of the TREO mineralisation below the MRE. DDH-007-013 and DDH-007-14 were collared 264 metres above the fan of holes and confirmed extensions to the TREO mineralisation to the south of the MRE. DDH-13-011, DDH-13-016 were drilled between the fan of holes and DDH-007-11 and 12. Drill hole intervals were assayed for a full suite of rare earth oxides plus zirconium oxide, tantalum oxide, and niobium oxide (See table 3 and figures 4, 5, and 6)Figure 2 - Drillhole collar positions for the new deep diamond holes in the Fjord Deposit area with the average assay results from surface. The Fjord rare-earth deposit is contained within a mineralized Kakortokite host unit covering an area of approximately 5km x 2.5km and several hundred metres thick and estimated at 4.7 billion tonnes. two areas have been delineated at Fjord and Hill and subject to detailed exploration and resource estimation. The host unit has not been fully explored, and the estimate of the mass of the kakortokite host unit does not presume any certainty of hosting economic mineralisation in other areas. The MRE drilling examined the drill intersections from surface to sea level (0m RL) and prepared a mineral resource estimate based on the TREO and zirconium and niobium oxides within the kakortokite including eudialyte, feldspar and arfvedsonite components. Drill holes DDH-007-08, DDH-007-09, DDH-007-12, DDH-007-14, DDH-13-011and DDH 13-016 were terminated in kakortokite containing greater than 3000ppm TREO mineralisation at the bottom of the respective drillholes (see figure 2).Table 3 - Assayed intersections in the 2007 and 2013 drilling announced 3 - Deep drilling extending below the Fjord Mineral Resource Estimate with section lines Figure 4 - Deep drilling extending below the Fjord Mineral Resource Estimate – Section FFigure 5 - Deep drilling extending below the Fjord Mineral Resource Estimate – Section CFigure 6 - Cross section on Fjord Section A The Mineral Resource Estimate for Tanbreez at the Fjord and Hill Deposits The Company recently announced its MRE for the Tanbreez Project of 45MT Eudialyte containing 0.38% TREO including 27% contained HREO plus rare metal oxides (see Nasdaq Press Release 17 March, 31 March and 19 May 2025) and Table 2,3 and Figure 4). The MRE are classified as Indicated and Inferred Resources under the JORC Code 2012 and have been determined by drill density and number of drillholes, and samples utilized in grade estimation. A recent Addendum to the Eudialyte component added information on the by-products, 134 million tonnes of Feldspar and 134 million tonnes of Arfvedsonite. Eudialyte concentrate will be prepared in Greenland and exported to the USA or Europe for further processing. Feldspar and Arfvedsonite from the Tanbreez deposit will be processed in Greenland to form a concentrate for industrial applications and further processing will be required to meet off- take standards. TANBREEZ PROJECT Million TREO ZrO2 Nb2O5 Tonnes % % % TANBREEZ HILL Eudialyte Indicated Resource Upper 3.20 0.47% 1.72% 0.14% Lower 13.46 0.30% 1.11% 0.11% Total 16.66 0.33% 1.22% 0.12% Inferred Resource Upper 0.93 0.40% 1.48% 0.13% Lower 4.72 0.28% 1.04% 0.10% Total 5.65 0.30% 1.11% 0.11% FJORD DEPOSIT Eudialyte Indicated Resource 8.76 0.44% 1.63% 0.17% Inferred Resource 13.80 0.42% 1.55% 0.16% Total 22.56 0.43% 1.58% 0.16% Eudialyte Total Indicated Resource 25.42 0.37% 1.37% 0.13% Inferred Resource 19.45 0.39% 1.42% 0.15% Total 44.87 0.38% 1.39% 0.14% Table 3 MRE eudialyte component TANBREEZ PROJECT Industrial Mineral Components TANBREEZ HILL Feldspar Indicated Resource 33.00 Mtonnes Inferred Resource 11.00 Mtonnes Arfvedsonite Indicated Resource 33.00 Mtonnes Inferred Resource 11.00 Mtonnes FJORD DEPOSIT Feldspar Indicated Resource 18.00 Mtonnes Inferred Resource 28.00 Mtonnes Arfvedsonite Indicated Resource 18.00 Mtonnes Inferred Resource 28.00 Mtonnes Table 4 MRE details for feldspar and arfvedsonite The Company confirms that it is not aware of any new information or data that materially affects the information included in the Company's previous estimation of the feldspar and arfvedsonite resources in this announcement and that all material assumptions and technical parameters underpinning the estimates continue to apply and have not materially 7 - Location of drilling in relation to the mineral resource estimate for indicated, inferred drill hole results and outcrop kakortokite at 8 - The Tanbreez Fjord and the Tanbreez Hill rare-earth mineral sites are hosted within a Kakortokite unit covering an area of approximately 5km x 2.5km, estimated at 4.7 billion tonnes of Kakortokite this does not indicate any certainty of hosting mineralisation About Critical Metals Corp Critical Metals Corp (Nasdaq: CRML) is a leading mining development company focused on critical metals and minerals, and producing strategic products essential to electrification and next generation technologies for Europe and its western world partners. Its flagship Project, Tanbreez, is one of the world's largest rare earth deposits and is located in Southern Greenland. The deposit is expected to have access to key transportation outlets as the area features year-round direct shipping access via deep water fjords that lead directly to the North Atlantic Ocean. Another key asset is the Wolfsberg Lithium Project located in Carinthia, 270 km south of Vienna, Austria. The Wolfsberg Lithium Project is the first fully permitted mine in Europe and is strategically located with access to established road and rail infrastructure and is expected to be the next major producer of key lithium products to support the European market. Wolfsberg is well positioned with offtake and downstream partners to become a unique and valuable asset in an expanding geostrategic critical metals portfolio. With this strategic asset portfolio, Critical Metals Corp is positioned to become a reliable and sustainable supplier of critical minerals essential for defense applications, clean energy transition, and next-generation technologies in the western world. For more information, please visit Cautionary Note Regarding Forward Looking Statements This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the 'Exchange Act'). Forward-looking statements include, without limitation, statements regarding the net present value, economic viability and prospects of the Tanbreez Project, the expected rare earth metal supply located and recoverable in the Tanbreez Project, the timing and completion of additional studies and operations related to the Tanbreez Project, as well as financial position, financial performance, business strategy, expectations of our business and the plans and objectives of management for future operations. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this news release, forward-looking statements may be identified by the use of words such as 'estimate,' 'plan,' 'project,' 'forecast,' 'intend,' 'will,' 'expect,' 'anticipate,' 'believe,' 'seek,' 'target,' 'designed to' or other similar expressions that predict or indicate future events or trends or that are not statements of historical facts. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors discussed under the 'Risk Factors' section in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission. These forward-looking statements are based on information available as of the date of this news release, and expectations, forecasts and assumptions as of that date, involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date, and we do not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Critical Metals Corp. 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