On April 23, 2026 Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported financial results for the quarter ended March 31, 2026, and provided a corporate update.

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"We entered 2026 with strong momentum and continue to execute across our differentiated therapeutics and diagnostics pipeline," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "The Phase 2b interim results for RAD 101, demonstrating 90% concordance with MRI in recurrent brain metastases, further validate the potential of our imaging platform and strengthen our confidence as we prepare for the next stages of development. In parallel, initial first-in-human data from RAD 202 showing meaningful tumor uptake and a favorable safety profile underscore the breadth of our therapeutic opportunities."

"Importantly, the initiation of two additional Phase 1 trials—RV-01 through our Radiopharm Ventures collaboration and RAD 402 in advanced prostate cancer—reflects the growing productivity of our platform and our disciplined approach to pipeline expansion. With multiple clinical milestones ahead, we are well positioned to build long-term value as we advance innovative radiopharmaceuticals for patients with high unmet needs," concluded Mr. Canevari.

Program and Business Updates

18F-RAD101 – Small molecule targeting fatty acid synthase radiolabelled with Fluorine-18

RAD 101 is being evaluated in a single-arm U.S. Phase 2b clinical trial for the diagnostic performance of the molecule in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to expedite the review process and help bring the novel imaging small molecule to the over 300,000 patients diagnosed annually in the U.S. with cerebral metastases.

In April 2026, the Company dosing the final patient in the Phase 2b imaging trial of RAD 101. Radiopharm Theranostics has signed a supply agreement with Siemens Healthineers, who will radiolabel and distribute RAD101 with Fluorine-18 (18F).
In March 2026, Radiopharm Theranostics reported interim data from twenty patients in the Phase 2b trial of RAD 101, with 90% of evaluable patients achieving concordance with MRI imaging, the primary endpoint.
These promising interim data are in line with the Phase 2a results and, if confirmed, will trigger the preparation of a multi-center, multi-country Phase 3 registrational trial.
177Lu-RAD202 – Nanobody targeting HER2 radiolabelled with Lutetium 177

The Company continues to evaluate RAD 202 in the Phase 0/1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. RAD 202 has demonstrated clinical proof-of-concept with positive safety and biodistribution.

In April 2026, Radiopharm presented data from the Phase 0/1 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026, which demonstrated meaningful tumor uptake of RAD 202, was generally well tolerated, included no dose-limiting toxicities, and organ-level absorbed radiation doses within the expected and clinically acceptable ranges.
Radiopharm Theranostics received a positive recommendation from the Data Safety and Monitoring Committee to advance RAD 202 to the next dose level of 130mCi in the Phase 1 ‘HEAT’ clinical trial.
The Company expects to complete enrolment in the higher dose Cohort 3 and to have data from both the second and third cohorts in mid-2026.
177Lu-RAD204 – Nanobody targeting PD-L1 radiolabelled with Lutetium 177

RAD 204 is continuing to be evaluated in a Phase 1 study in PD-L1-driven cancers, including Non-Small Cell Lung Cancer (NSCLC), Small-Cell Lung Cancer (SCLC), Triple-negative Breast Cancer (TNBC), Cutaneous Melanoma, head and neck squamous cell carcinoma (HNSCC) and Endometrial Cancer. Previous Phase 1 imaging data of 16 NSCLC patients treated with RAD 204 demonstrated that the diagnostic compound is safe and is associated with acceptable dosimetry.

The Company completed enrolment of the second Cohort of the Phase 1 study of RAD 204 and can proceed with dosing patients in the third Cohort with an updated dose of 90mCi of Lu177 as approved by the Data and Safety Monitoring Committee.
Two out of three patients in the 30mCi cohort exhibited stable disease for 5.5 months in metastatic NSCLC, compared to historical data of 3.5 months PFS with standard of care (SOC).
Initial data from the first two cohorts show tumor uptake in the PD-L1-positive lesions, in line with published results of the previously conducted imaging study.
RAD 204’s safety profile is reassuring and there have been no drug-related adverse events reported.
Data from the third cohort of patients at 90mCi in the Phase 1 study of RAD 204 are expected mid-2026.
Lu177-RV 01 – monoclonal antibody targeting 4Ig isoform of B7H3 radiolabelled with Lutetium 177

RV 01 (Betabart) is a monoclonal antibody targeting the 4Ig isoform of B7H3, an immune checkpoint protein that is highly expressed in tumors and not in healthy tissue. In multiple preclinical studies, RV-01 has shown tumor shrinkage and prolonged survival. This is the first radiopharmaceutical therapeutic developed by Radiopharm Ventures, a joint venture between Radiopharm Theranostics and the MD Anderson Cancer Center.

In February 2026, the first patient was dosed in the First-In-Human (FIH) Phase 1/2a clinical trial, which is designed to establish the safety profile, biodistribution, pharmacokinetics, and radiation dosimetry of RV-01 in various tumor types. The trial will also determine the recommended dose of RV-01 for future studies.
In January 2026, the Company increased its ownership in Radiopharm Ventures from 75% to 87.5% as the joint venture continues to show promising progress in its cancer therapeutic pipeline, including the advancement of its leading B7H3 candidate and other preclinical assets.
Tb161-RAD 402 – Monoclonal antibody targeting KLK3 radiolabelled with Terbium 161

RAD 402 is a monoclonal antibody targeting Kallikrein Related Peptidase 3 (KLK3) radiolabelled with the radionuclide 161Tb for the treatment of prostate cancer. In preclinical studies, RAD 402 in mouse xenografts showed strong tumor targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody.

In March 2026, the first patient was dosed in the First-In-Human (FIH) Phase 1 clinical trial of RAD 402, designed to evaluate the safety, tolerability, whole-body distribution, and preliminary clinical activity of RAD 402 in patients with advanced prostate cancer. The dose escalation Phase 1 study is designed to determine the Maximum Tolerated Dose and recommended Phase 2 dose for expansion.
Ga68-RAD301 – Peptide targeting αvB-integrin radiolabeled with Gallium 68

RAD 301 is being evaluated in a Phase 1 imaging trial in patients with Pancreatic Ductal Adenocarcinoma (PDAC). The αvB-integrin is a cellular marker for tumor invasion and metastatic growth, which correlates with decreased survival in several carcinomas, particularly pancreatic. RAD 301 has previously received Orphan Drug Designation (ODD) from the FDA and data from the Phase 1 trial is supportive of the Company’s decision to move to a Phase 2 imaging trial in patients with loco-regional pancreatic cancer.

Enrolment in the Phase 1 imaging trial in metastatic pancreatic cancer continues, having dosed 8 patients out of 9, with last patient expected mid-2026.
Initial data from the first six patients demonstrated confirmed safety and significant uptake in the AvB6 positive lesions.
Financial Update

Closing cash at the end of the quarter was $19.2 million, decreasing from $34.5 million at the end of the prior quarter.

Net cash outflows from operating activities during the period was $14.9 million with direct Research and Development expenditure and staff costs accounting for 95% of the operating activities.

In compliance with Listing Rule 4.7C, payments to related parties and their associates, as detailed in item 6.1 of Appendix 4C, encompass remuneration for director fees to executive and non-executive directors, conducted in the ordinary course of business at commercial rates, excluding reimbursements for out-of-pocket expenses.

(Press release, Radiopharm Theranostics, APR 23, 2026, View Source [SID1234664743])

On April 23, 2026 Transcenta Therapeutics (HKEX: 06628), a global clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported the presentation of preclinical data highlighting its proprietary LIV1-targeting antibody-drug conjugates (ADC) at the 2026 AACR (Free AACR Whitepaper) Annual Meeting. The data demonstrate strong anti-tumor activity, differentiated payload-dependent efficacy, and favorable tolerability profiles, supporting further development in LIV1-positive solid tumors.

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LIV1 is a member of the zinc transporter family, with limited normal tissue expression, and is found to be overexpressed with high prevalence in breast (93%), prostate (72%) and lung (10%) cancers, making it an attractive cell surface target for developing ADC therapeutics.

Transcenta Therapeutics has developed 48D6, a novel proprietary humanized anti-LIV1 monoclonal antibody with high affinity, specificity, and internalization capability. Using Retrogenix cell microarray technology, 48D6 demonstrated no non-specific interactions with other human proteins, confirming its high target specificity. Leveraging 48D6, Transcenta Therapeutics then generated two ADC candidates using a glycotransferase-mediated site-specific conjugation platform: ADC-2, conjugated with a Topoisomerase I inhibitor payload, and ADC-3, conjugated with MMAE.

Pharmacokinetic studies in Balb/c mice showed that ADC-2 exhibited a half-life of approximately 10.4–11.6 days, significantly longer than that of a benchmark SGN-LIV1A analog (3.7–3.9 days), and comparable to the naked antibody 48D6 (13.8–15.6 days), indicating favorable in vivo stability.

In vivo efficacy studies demonstrated that ADC-2 elicited potent anti-tumor activity in LIV1-expressing ER+/HER2- breast cancer and non-small cell lung cancer (NSCLC) patient-derived xenograft (PDX) models at a dose of 6 mg/kg administered once weekly for four weeks.

For LIV1 expressing prostate PDX models, ADC-2 demonstrated limited tumor growth inhibition after two doses. After MMAE-based ADC-3 replaced ADC-2 from the 3rd dose, ADC-3 inhibited the growth of the prostate tumor significantly. In a LIV1 high expressing prostate PDX, the tumor growth was suppressed by ADC-3 for more than 70 days after the dosing was stopped.

In exploratory toxicity studies to assess safety and tolerability, ADC-2 was well tolerated following repeated administrations in mice at all doses tested. Slight lesions were observed in 60 mg/kg group during the treatment period and fully recovered at the end of the recovery period. Based on these results, the maximum tolerated dose (MTD) of ADC-2 in mice was determined at 60 mg/kg. The safety and tolerability of ADC-3 has not yet been explored.

Collectively, these data demonstrate that Transcenta’s LIV1-targeting ADC-2 and ADC-3 programs exhibited strong anti-tumor activities as monotherapy in PDX models of ER+/HER2- breast cancer (representing ~60% of all breast cancers) and also prostate cancer. ADC-2 also displayed excellent tolerability profile in mice. Notably, Transcenta’s LIV1-targeting ADCs also demonstrated potent anti-tumor activity in triple-negative breast cancer (TNBC) tumor models, with data previously presented at the 2024 SABCS. These results support further investigation of Transcenta’s LIV1 ADCs in LIV1-positive solid tumors.

(Press release, Transcenta, APR 23, 2026, View Source [SID1234664742])

On April 23, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that an abstract submission from a pharmacokinetic (PK) and pharmacodynamic sub‑study of its ongoing Phase III TIGeR‑PaC clinical trial locally advanced pancreatic cancer has been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The abstract, entitled "The TIGeR-PaC Phase 3 III Clinical Trial Examining Intra-Arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic and Pharmacodynamic Sub-Study," explores RenovoRx’s lead product candidate, intra-arterial delivery of gemcitabine via RenovoCath (known as IAG), and its potential to reduce systemic levels of the chemotherapy gemcitabine and increase levels of its inactive metabolite compared with intravenous gemcitabine. Additionally, the abstract studies IAG administration and its direct correlation between the metabolite levels and CA 19-9, a biomarker commonly used to assess potential chemotherapy response.

"This study provides important insights into how targeted intra-arterial delivery of chemotherapy may optimize drug distribution and pharmacologic activity in locally advanced pancreatic cancer," said Dr. Ramtin Agah, RenovoRx’s Executive Chairman and Chief Medical Officer, and study co-author. "We believe IAG has the potential to enhance effectiveness of therapeutic delivery while reducing systemic toxicity and common side effects."

The 2026 ASCO (Free ASCO Whitepaper) Annual Meeting will be held May 29 – June 2, 2026, in Chicago, Illinois, with the online publication of the abstract scheduled for May 21, 2026, at 5:00 P.M. ET.

Abstract Details:
Online Publication Date & Time: May 21, 2026, at 5:00 P.M. ET
Number for Publication: E16463
Title: The TIGeR-PaC Phase III Clinical Trial Examining Intra-Arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic and Pharmacodynamic Sub-Study.

(Press release, Renovorx, APR 23, 2026, View Source [SID1234664741])

On April 23, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428) reported its results and business highlights for the first quarter of 2026 as of 31 March 2026.

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Over the past decade, InnoCare has achieved remarkable results. 2026 marks the beginning of the Company’s next golden decade of development. Driven by its outstanding performance in 2025, the Company continued its rapid progress in the first quarter of 2026, increasing its investment in innovation, commercialization and globalization to achieve its 2.0 strategic goals.

Commercialization & BD Drive Sustainable Profitability
InnoCare’s drug sales in the first quarter of 2026 increased by 44.5% year-on-year (YoY), reaching RMB 450.5 million, and total revenue grew by 38.7%YoY to reach RMB 528.6 million, primarily driven by commercial growth and incremental income generated from global business development (BD) initiatives. Orelabrutinib has grown rapidly since the inclusion of its new indication for first line chronic lymphocytic leukemia/small lymphocytic lymphoma (1L CLL/SLL) in the National Reimbursement Drug List (NRDL), while maintaining its exclusive indication advantage in marginal zone lymphoma (MZL). Meanwhile, the commercialization of tafasitamab and zurlectrectinib has brought new growth opportunities.

Based on its first full year profitability in 2025, InnoCare remained profitable in the first quarter of 2026, with net profit increasing by 607.7% YoY to RMB 102.4 million.

InnoCare’s Research and Development (R&D) Investment increased by 10.4% YoY to RMB 229.2 million in the first quarter of 2026, reflecting advancements of global registrational trials, as well as increased investment in new technology platforms such as ADCs and molecular glue.

Cash and Related Accounts Balance1 stood at approximately RMB 7.9 billion as of 31 March 2026. This strong cash position provides InnoCare with the flexibility to expedite global clinical development of key assets and invest in new technology platforms.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "Standing at the new starting point of the next decade of development, we maintained strong growth momentum in the first quarter of 2026, with enhanced market penetration, accelerated globalization, and breakthroughs across multiple pipelines, laying a solid foundation for high-quality development throughout the year of 2026. Upholding the core value of ‘Science driving innovation for the benefit of patients’, we will continue to uplift our innovation, commercialization and globalization, and accelerate clinical trials in China and globally, so as to benefit more patients worldwide."

Enhanced Commercialization
In the first quarter of 2026, all four approved indications of orelabrutinib were included in the updated NRDL. InnoCare achieved rapid growth in orelabrutinib following the inclusion of 1L CLL/SLL in the NRDL, while maintaining its exclusive indication advantage in MZL. Additionally, both tafasitamab and zurletrectinib have been approved for marketing in 2025 and have begun to contribute to sales. Tafasitamab became the first CD19 antibody approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in China, while the next-generation TRK inhibitor, zurletrectinib, has been prescribed in hospitals across China. As a result, drug sales increased by 44.5%, reaching RMB 450.5 million in the first quarter of 2026.

The Company’s commercial team has further strengthened its execution capabilities and focused on strategic priorities, laying a solid foundation for sustained revenue growth and long-term business success.

Continued Breakthroughs Across Multiple Pipelines
Effective 27 March 2026, the special "U" designation was officially removed from the Company’s stock ticker in the STAR market, marking InnoCare’s entry into a phase of sustainable growth and development. Ten years of hard work have laid a solid foundation, and 2026 marks the beginning of a new decade for the Company. Building on its outstanding performance throughout 2025, the Company continued its high-quality and rapid development in the first quarter of 2026. The following are the main achievements during this period.

The Phase III clinical trial of the novel BCL2 inhibitor mesutoclax (ICP-248) in combination with orelabrutinib as a first-line treatment for CLL/SLL has completed patient enrollment. This fixed-duration therapy is expected to achieve deeper remissions in treatment-naïve CLL/SLL patients, while avoiding resistance mutations and offering the hope for a clinical cure.

As the first BCL2 inhibitor granted breakthrough therapy designation (BTD) in China, mesutoclax’s latest data will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The registrational trial in BTKi-treated mantle cell lymphoma (MCL) is progressing rapidly. In addition, global clinical trials of mesutoclax in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) are advancing across China, U.S., and Australia.

The New Drug Application (NDA) for orelabrutinib in primary immune thrombocytopenia (ITP) is expected to be submitted in the first half of 2026. The Phase III trial of orelabrutinib in systemic lupus erythematosus (SLE) has been initiated. Orelabrutinib’s two Phase III clinical trials for Primary Progressive Multiple Sclerosis (PPMS) and for Secondary Progressive Multiple Sclerosis (SPMS) are progressing.

The first healthy volunteer has been dosed in the clinical trial of ICP-538, the first VAV1 degrader approved to enter clinical trials in China and the second globally. ICP-538 is a novel, potent, highly selective, orally administered molecular glue degrader targeting VAV1, a key protein downstream of T-cell and B-cell receptors. ICP-538 will be developed for the treatment of autoimmune diseases, such as inflammatory bowel disease (IBD), systemic lupus erythematosus (SLE), and multiple sclerosis (MS).

The novel oral IL-17AA/AF inhibitor ICP-054 (ZB021) has received IND approval. ICP-054 is a novel, oral, highly potent and selective IL-17AA/AF inhibitor with significant therapeutic potential in autoimmune and inflammatory diseases. ICP-054 can effectively block the signal transduction pathways of IL-17AA homodimer and IL-17AF heterodimer, thereby inhibiting the release of pro-inflammatory cytokines and chemokines, exerting an anti-inflammatory effect. Simultaneously, it reduces excessive proliferation of keratinocytes and inflammatory cell infiltration, improving skin lesions and thus suppressing the occurrence of autoimmune and inflammatory diseases.

The CD20xCD3 T-cell engager (TCE) ICP-B02 (PRO-203) has completed single ascending dose (SAD) trials of healthy volunteers for severe autoimmune diseases. Meanwhile, Prolium, InnoCare’s partner, expects to initiate a multinational Phase I/II trial in systemic sclerosis (SSc) in the second quarter of 2026, with additional studies in other severe B-cell-driven autoimmune diseases to start this year.

The novel TYK2 inhibitor soficitinib (ICP-332) has completed patient enrollment in its Phase III clinical trial for moderate to severe atopic dermatitis (AD). The Phase II clinical study of soficitinib in patients with vitiligo has also completed patient enrollment. Data from the Phase II clinical trial of soficitinib in patients with moderate-to-severe AD was published in JAMA Dermatology. The journal concluded that soficitinib demonstrated a favorable safety profile and encouraging efficacy in patients with AD.

The novel TYK2 inhibitor ICP-488 has completed patient enrollment in its Phase III clinical trial for psoriasis, potentially providing a new oral treatment option for patients with psoriasis.

The next-generation TRK inhibitor zurletrectinib was granted priority review for the treatment of pediatric patients (ages 2–12) with solid tumors harboring NTRK fusions.

The novel B7-H3 targeted ADC ICP-B794 showed promising preclinical data and was selected for presentation at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. The Phase I ascending dose trial is progressing.

The IND application for the novel CDH17-targeted ADC ICP-B208 has been submitted which will be developed for the treatment of gastrointestinal cancers, including gastric, colorectal, pancreatic ductal adenocarcinoma, and cholangiocarcinoma. Preclinical studies show that ICP-B208 demonstrates potent anti-tumor activity even in CDH17-low tumors.

Accelerating Globalization
In 2025, InnoCare accelerated its globalization strategy, focusing on unlocking the global value of its core pipelines, and completed two out-licensing transactions, further enhancing the Company’s globalization efforts and financial performance, and marking a significant breakthrough in its global expansion.

In 2026, InnoCare will continue to build long-term, win-win partnerships through business development, promote the Company’s globalization process, and bring more benefits and growth opportunities to the Company and its partners, while benefiting patients worldwide.

(Press release, InnoCare Pharma, APR 23, 2026, View Source [SID1234664740])

On April 23, 2026 LeonaBio, Inc. (NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, reported that it will host a virtual Key Opinion Leader event with two leading physician experts in the breast cancer field to discuss the current and evolving treatment landscape in metastatic breast cancer and the potential for lasofoxifene to transform the standard of care for patients with treatment-resistant estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer.

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The event titled, "Modulation and Combination: the Potential for Lasofoxifene to Transform the Standard-of-Care in Metastatic Breast Cancer," will take place on Wednesday, April 29, 2026, beginning at 12:00 p.m. ET. To participate in the event, register here.

"As we look toward completing enrollment in ELAINE-3 later this year, with data expected in the second half of 2027, we are pleased to be joined by two leading voices in the breast cancer field to discuss the evolving treatment landscape in metastatic disease," said Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio. "This conversation will highlight the persistent gaps in care, particularly for genetically defined populations, and the potential for lasofoxifene to address a critical unmet need in patients with treatment-resistant ER+, HER2-, ESR1-mutated metastatic breast cancer."

The webcast event will feature a discussion with David Portman, M.D., Chief Executive Officer of Sermonix Pharmaceuticals and an oncology consultant to LeonaBio, along with two physician experts in the breast cancer field:

Matthew P. Goetz, M.D., Erivan K. Haub Family Professor of Cancer Research Honoring Richard F. Emslander, M.D, Mayo Clinic, Principal investigator and director, Breast Cancer Specialized Program of Research Excellence (SPORE), Mayo Clinic Comprehensive Cancer Center and Enterprise Deputy Director, Translational Research, Mayo Clinic Comprehensive Cancer Center.
Seth Wander, M.D., Ph.D., Director of Precision Medicine, Termeer Center for Targeted Therapies, Director of Translational Research, Breast Oncology Program, Mass General Brigham Cancer Institute, Assistant Professor of Medicine, Harvard Medical School.

In addition to the live webinar, the event will be archived on the LeonaBio website under Events in the Investor Relations here.

About Metastatic Breast Cancer
Metastatic breast cancer (MBC) occurs when cancer spreads from the breast to other parts of the body—such as bones, lungs, liver, or brain. While approximately two-thirds of breast cancers are diagnosed at a localized stage, a notable proportion either present as metastatic at diagnosis or progress to that stage over time. From 2001 to 2021, approximately 4.65 million new cases of female breast cancer were reported in the United States, with approximately 260,000 (5.6%) diagnosed as distant (metastatic) stage at initial diagnosis. The metastatic breast cancer treatment market represents a sizable and rapidly expanding global opportunity with a global market of $17.1 billion in 2021, expected to expand to $41.7 billion by 2030, with a compound annual growth rate (CAGR) of approximately 10.4%. These projections reflect a market rich with innovation—from chemotherapy and hormone therapies to biologics, targeted agents and emerging personalized medicine. Growth is driven by the persistent incidence of metastatic disease, regulatory and clinical advances and evolving treatment landscapes.

About Lasofoxifene
Lasofoxifene is a novel, nonsteroidal selective estrogen receptor modulator (SERM) with a unique binding profile, designed to confer potent activity against both wild-type and mutant estrogen receptors, including the clinically significant ESR1 mutations commonly associated with resistance to endocrine therapy in metastatic breast cancer. Two Phase 2 studies—ELAINE-1 and ELAINE-2—have demonstrated its potential to address a critical unmet need in this patient population.

ELAINE-1, a randomized trial comparing lasofoxifene to fulvestrant, showed improved outcomes for lasofoxifene, including longer median progression-free survival (5.6 vs. 3.7 months), higher objective response rates (13.3% vs. 2.9%), and a durable complete response lasting more than 2.5 years. Patients also reported quality-of-life benefits and the treatment was well tolerated.

ELAINE-2, an open-label study evaluating lasofoxifene in combination with abemaciclib, demonstrated clinical benefits in heavily pretreated patients, with a median progression-free survival of approximately 13 months, an objective response rate of 56%, and a clinical benefit rate of 65.5%. The combination was generally well tolerated, with most adverse events being low grade.

Lasofoxifene is being advanced in a Phase 3 clinical trial as a targeted therapy for estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer, a population with limited treatment options following progression on aromatase inhibitors and CDK4/6 inhibitors. The ongoing ELAINE-3 trial (NCT05696626) is evaluating lasofoxifene in combination with the CDK4/6 inhibitor, abemaciclib, and is aiming to establish a new standard of care for this genetically defined patient group.

(Press release, LeonaBio, APR 23, 2026, View Source [SID1234664739])