Legend Biotech Corporation American Depositary Shares - LEGN STOCK NEWS

Legend Biotech (NASDAQ: LEGN), a global cell therapy leader, has released preliminary, unaudited financial results for the six months ended June 30, 2024. The company anticipates an adjusted net loss between $94.7 million and $109.7 million for this period. This estimate excludes equity-settled share-based compensation expenses (net of tax) of $38.4-$44.5 million and exchange gains of $57.7-$66.8 million. Legend Biotech's actual net loss is expected to be $75.4-$87.4 million. The company emphasizes that these are preliminary estimates subject to change, with final results to be reported on August 9, 2024. Legend Biotech uses non-IFRS financial measures, including adjusted net loss, to comply with Hong Kong Stock Exchange listing rules.

Legend Biotech (NASDAQ: LEGN) will host an investor conference call on August 9, 2024, at 8:00 am ET to discuss its Q2 2024 results. The company's senior leaders will review the quarterly performance during the webcast. Investors can join the live audio webcast via a provided weblink, and a replay will be accessible in the Investor Relations section of Legend Biotech's website approximately two hours after the call concludes.

Legend Biotech (NASDAQ: LEGN) announced positive overall survival results from the Phase 3 CARTITUDE-4 trial, evaluating CARVYKTI® in relapsed and lenalidomide-refractory multiple myeloma. The trial showed statistically significant and clinically meaningful improvement in overall survival compared to PVd and DPd regimens.

The safety profile was consistent with previous data, and no new safety signals were identified. The results will be shared with regulatory agencies for potential updates. CARVYKTI® had already gained FDA approval on April 5, 2024.

However, the study reported a higher percentage of early deaths in the CARVYKTI® arm, primarily due to adverse events and infections. Other risks include cytokine release syndrome, neurologic toxicities, and secondary malignancies.

Legend Biotech shared promising data on CARVYKTI® (ciltacabtagene autoleucel) for treating multiple myeloma at ASCO and EHA 2024. The CARTITUDE-2 Cohort D study showed a 94% overall response rate and 80% MRD negativity with one-time CARVYKTI® infusion. CARTITUDE-4 analysis revealed CARVYKTI® improved progression-free survival (PFS) vs standard therapy in high-risk patients. The efficacy of CARVYKTI® was consistent across different cytogenetic abnormalities. However, safety concerns including CRS, ICANS, and infections were noted.

These findings support CARVYKTI®'s potential as a new standard of care for high-risk multiple myeloma patients refractory to lenalidomide. Further Phase 3 studies are underway to evaluate CARVYKTI® in earlier treatment settings.

Legend Biotech (NASDAQ: LEGN), a global leader in cell therapy, announced that CEO Ying Huang, Ph.D., will participate in a fireside chat at the Jefferies Global Healthcare Conference. This event will take place in New York, NY, on June 6, 2024, at 10:30 a.m. ET. Investors and other interested parties can view the live webcast through the Investor Relations section of Legend's website. A replay will be available approximately 48 hours after the event.

Legend Biotech (NASDAQ: LEGN) will present new data on its CAR-T cell therapy, CARVYKTI®, for multiple myeloma at the 2024 ASCO and EHA events.

Significant upcoming presentations include:

• Phase 2 CARTITUDE-2 study data will be presented at ASCO and EHA.
• Phase 3 CARTITUDE-4 study data regarding high-risk multiple myeloma will also be showcased.

Key studies analyze CARVYKTI®'s effectiveness in patients with different risk profiles and those who had suboptimal responses to previous treatments.

Despite positive advancements, warnings about severe side effects such as cytokine release syndrome, neurologic toxicities, and other serious adverse events were noted.

Legend Biotech (NASDAQ: LEGN) reported first quarter 2024 financial results with CARVYKTI® net trade sales of $157 million, FDA label expansion, and a milestone payment of $45 million. The company's cash position stands at $1.3 billion, ensuring financial stability until 2026. Legend Biotech's recent developments include increased manufacturing capacity, regulatory approvals in the U.S., Europe, and Brazil, and a Master Manufacturing and Supply Services Agreement with Novartis. The company's ESG report aligns with SASB standards, and the collaboration revenue has shown significant growth.

Legend Biotech's CARVYKTI® (ciltacabtagene autoleucel) has been approved by the European Commission for the treatment of relapsed and refractory multiple myeloma. This approval was granted based on positive results from the CARTITUDE-4 study, showing significant improvement in progression-free survival compared to standard treatments. The approval may revolutionize the treatment landscape for multiple myeloma patients, offering new hope and options.

Legend Biotech (LEGN) will host a conference call to review first-quarter 2024 results. Senior leaders will provide an overview of the company's performance. Investors can join the live webcast and access a replay version later.