BridGene Eligible to Receive Up to $159 Million in Total Payments SAN JOSE, Calif., Aug. 1, 2024 /PRNewswire/ -- BridGene Biosciences, Inc., a leader in the discovery of small molecule drugs for traditionally "hard-to-drug" targets, today announced an expansion to its strategic collaboration and licensing agreement with Galapagos NV (Euronext: GLPG) (NASDAQ: GLPG). This new collaboration builds upon the partnership initiated in January 2024, focusing on the discovery of a highly selective oral SMARCA2 small ...

Core Insights - The company is making significant progress on its "Forward, Faster" strategy, focusing on regulatory and clinical milestones, expanding cell therapy manufacturing capabilities, and advancing early-stage programs [1][3][4] Regulatory and Clinical Developments - The company submitted an IND application to the FDA for the Phase 1/2 ATALANTA-1 study of CD19 CAR-T candidate GLPG5101 in relapsed/refractory non-Hodgkin lymphoma (R/R NHL) [1][5] - A CTA was submitted to the EMA for the Phase 2 study of GLPG5201 in relapsed/refractory chronic lymphocytic leukemia (R/R CLL) [1][5] - The IND filing for the Phase 1/2 EUPLAGIA-1 study of GLPG5201 is on track for Q4 2024 [1][5] - New Phase 1/2 data for GLPG5101 and GLPG5201 shows promising safety and efficacy for fresh CD19 CAR-T therapies [1][5] Strategic Collaborations - A strategic collaboration with Blood Centers of America has been established to enhance the cell therapy manufacturing network across the U.S., complementing existing partnerships with Landmark Bio and Thermo Fisher Scientific [1][4][5] - The company signed a clinical collaboration agreement with Adaptimmune for next-generation TCR T-cell therapy, with potential milestone payments totaling up to $465 million [7] - An expanded collaboration with BridGene Biosciences aims to develop a selective oral SMARCA2 small molecule in precision oncology [7] Financial Performance - Total net revenues for the first half of 2024 reached €140.3 million, an 18% increase from €118.6 million in the same period of 2023 [6][13] - R&D expenses increased to €145.2 million, up 34% from €108.7 million in the first half of 2023, primarily due to higher costs in oncology programs [10][13] - The company reported a net profit of €99.2 million for the first half of 2024, compared to €28.3 million in the same period of 2023 [10][16] Cash Position and Outlook - As of June 30, 2024, the company had cash and current financial investments totaling €3.4 billion [21] - The cash burn guidance for 2024 is reaffirmed at €280 million to €320 million, with total cash burn including business development projected between €370 million and €410 million [22][1] - The company aims to initiate at least one first-in-human study in 2025 and introduce at least two new clinical candidates annually starting in 2026 [9][1]

GLPG5101 Clinical Trial Data - GLPG5101, a CD19 CAR-T candidate, showed promising results in the Phase 1/2 ATALANTA-1 study for relapsed/refractory non-Hodgkin lymphoma (R/R NHL) [1] - As of December 20, 2023, 34 patients (17 in Phase 1 and 17 in Phase 2) received GLPG5101 with a median vein-to-vein time of seven days [3] - In Phase 1, 14 of 16 efficacy-evaluable patients responded to treatment (ORR 87.5%), with 12 achieving a complete response (CRR 75%) [16] - In Phase 2, 14 of 15 efficacy-evaluable patients responded to treatment (ORR 93.3%), with all responders achieving a complete response (CRR 93.3%) [16] - High ORR and CRR were observed across different lymphoma types: DLBCL (ORR 78%, CRR 56%), FL/MZL (ORR and CRR 94%), and MCL (ORR and CRR 100%) [16] - Durable responses were observed, with 71% of Phase 1 patients and 100% of Phase 2 patients maintaining responses at data cut-off [16] GLPG5101 Safety Profile - GLPG5101 demonstrated an encouraging safety profile, with most treatment-emergent adverse events (TEAEs) being Grade 1 or 2 [16] - Two cases of Grade 3 cytokine release syndrome (CRS) were observed in Phase 1, and one case of Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in Phase 2 [16] - No unexpected safety findings were observed as of the data cut-off date [10] Galapagos' T-Cell Manufacturing Platform - The company's decentralized T-cell manufacturing platform enables a median vein-to-vein time of seven days, eliminating the need for bridging therapy [2] - The platform consists of xCellit® workflow management software, Lonza's Cocoon® automated manufacturing system, and proprietary quality control testing [6] - The final CAR-T product showed a higher proportion of early phenotypes of CD4+ and CD8+ CAR T cells compared to starting material, indicating improved cell quality during manufacturing [2] Non-Hodgkin Lymphoma Overview - Non-Hodgkin lymphoma is a cancer originating from lymphocytes, with B-cell lymphoma accounting for about 85% of cases in the US [5] - The disease can be aggressive (fast-growing) or indolent (slow-growing), with prognosis and treatment depending on the stage and type [5] Presentation Details - The new data will be presented at the European Hematology Association (EHA) 2024 Hybrid Congress by Marie José Kersten, M.D. [18] - The presentation will include updated safety and efficacy data for GLPG5101 in patients with DLBCL, FL, MZL, and MCL, as well as durability and cellular kinetics data [10]

Mechelen, Belgium; 16 May 2024, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announced today that its Board of Directors created 1,614,000 subscription rights under new subscription right plans for the benefit of certain members of the personnel of the company and its subsidiaries. On 16 May 2024, the Board of Directors of Galapagos approved "Subscription Right Plan 2024 BE", intended for members of personnel of the company, "Subscription Right Plan 2024 RMV," intended for the e ...

Mechelen, Belgium; 16 May 2024, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announced today that its Board of Directors created 1,614,000 subscription rights under new subscription right plans for the benefit of certain members of the personnel of the company and its subsidiaries. On 16 May 2024, the Board of Directors of Galapagos approved "Subscription Right Plan 2024 BE", intended for members of personnel of the company, "Subscription Right Plan 2024 RMV," intended for the e ...

"Our collaboration with Blood Centers of America marks a major milestone for Galapagos' U.S. expansion by establishing centers for support of our pivotal studies, with the potential to be used for commercial introduction. Working with BCA's extensive nationwide network allows us to efficiently scale up decentralized CAR-T therapy manufacturing across the U.S., while their established infrastructure helps us harmonize operations and access apheresis capacity," said Dr. Paul Stoffels1, CEO and Chairman of the ...

Financial Data and Key Metrics Changes - The company reported an operational cash burn of EUR 125 million for Q1 2024, which is on the higher end due to the phased transition of services for the Jyseleca business to Alfasigma [20] - The cash balance as of March 31, 2024, amounted to EUR 3.6 billion, indicating a strong financial position to support R&D and collaboration opportunities [16][37] - A net profit was recorded driven by fair value adjustments, foreign exchange, and EUR 25 million in interest income, along with a net profit from discontinued operations of EUR 67 million mainly from the Jyseleca transaction [98] Business Line Data and Key Metrics Changes - The company is progressing its Phase I/II CAR-T programs, specifically 5101 in NHL and 5201 in CLL and Richter's transformation, with ongoing clinical trials showing encouraging efficacy and safety results [10][11] - Revenue remained flat year-over-year, primarily consisting of the linear recognition of the platform for the Gilead collaboration, while R&D costs increased due to investments in oncology [36] Market Data and Key Metrics Changes - The company is expanding its decentralized CAR-T manufacturing network in both the U.S. and Europe, collaborating with Landmark Bio and Thermo Fisher to enhance capacity [35] - The company aims to submit IND applications for its NHL trial and CLL and Richter's transformation trials in the U.S. in mid and second half of 2024, respectively [99] Company Strategy and Development Direction - The company focuses on driving value creation in immunology and oncology, addressing significant unmet medical needs through a revitalized pipeline and strong leadership [8][15] - The strategy includes a decentralized manufacturing model for CAR-T therapies, allowing for greater physician oversight and scalability [18][94] - The company is actively pursuing business development opportunities, including licensing and acquisitions, to broaden its portfolio and enhance its R&D capabilities [53][54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory path forward for the CLL program and the potential to significantly contribute to patient care [2][3] - The company anticipates important regulatory progress with its CAR-T trials in the U.S. and aims to confirm safety, efficacy, and durability data in upcoming hematology conferences [21][76] - Management highlighted the high unmet medical need in the market and the opportunity to improve patient outcomes with their innovative therapies [85][92] Other Important Information - The company has over 15 discovery programs across oncology and immunology, with plans to deliver the first preclinical candidates this year and start first-in-human studies in 2025 [96] - The management team has extensive experience, having brought over 30 drugs to market, which supports the company's capabilities in driving value creation [9] Q&A Session Summary Question: Is the tech transfer a gating factor for rapid enrollment in trials? - Management confirmed that the tech transfer is crucial for patient recruitment and is aligned with ongoing clinical programs in Europe, with plans to accelerate in the U.S. [26][57] Question: When can we expect the next data from programs 5101, 5201, and 5301? - Management indicated that data will be presented in upcoming hematology conferences, with continuous enrollment and updates expected throughout 2024 [29][76] Question: How does the decentralized manufacturing process add value to multiple myeloma treatment? - Management noted that fresh cells provide significant efficacy and safety, and the decentralized model allows for closer proximity to patients, potentially improving outcomes [45][47] Question: What is the company's approach to business development opportunities? - Management stated that both licensing and M&A are on the table, focusing on high unmet medical needs and opportunities to add substantial value [53][67] Question: How does the company view competition in the CAR-T space? - Management believes their Cocoon system offers scalability and addresses high unmet medical needs, differentiating them from competitors [60][62]

Financial Performance - Group net revenues for Q1 2024 amounted to €100 million, reflecting a 7% increase from €58.6 million in Q1 2023[5] - Net profit from continuing operations for Q1 2024 was €23.5 million, compared to a net loss of €11.2 million in Q1 2023[12] - Total net revenues for Q1 2024 reached €62,432 thousand, an increase of 6.3% compared to €58,574 thousand in Q1 2023[26] - Net profit for Q1 2024 was €90,220 thousand, significantly higher than €23,207 thousand in Q1 2023, marking a year-over-year increase of 287.5%[26] - Total comprehensive income attributable to owners of the parent for Q1 2024 was €94,468 thousand, compared to €23,148 thousand in Q1 2023[27] Research and Development - R&D expenses increased by 36% to €71.6 million in Q1 2024, up from €52.5 million in Q1 2023, primarily due to higher costs for CAR-T and small molecule programs[7] - Research and development expenses rose to €71,614 thousand in Q1 2024, up 36.3% from €52,559 thousand in Q1 2023[26] - The company plans to file Investigational New Drug applications in the U.S. for its CAR-T programs in hemato-oncology[22] - The company is expanding its decentralized CAR-T network in the U.S. and Europe, aiming to enhance its clinical programs[3] - The company has a decentralized CAR-T manufacturing network aimed at enhancing its capabilities in oncology and immunology[23] Cash and Financial Position - Cash and current financial investments totaled €3.6 billion as of March 31, 2024, down from €4.0 billion at the end of 2023[15] - The company reaffirmed its cash burn guidance for 2024 at €280 million to €320 million, a decrease from €414.8 million in 2023[16] - Cash and cash equivalents decreased to €73,372 thousand from €166,803 thousand at the end of 2023, reflecting a decrease of 56.0%[28] - The operational cash burn for the first three months of 2024 amounted to €125.2 million[34] - The decrease in cash and cash equivalents for the same period was €93.9 million[34] Discontinued Operations - The transfer of the Jyseleca® business to Alfasigma was completed on January 31, 2024, impacting revenue recognition and operational costs[8] - Total operating profit from discontinued operations was €66.7 million in Q1 2024, compared to €36.1 million in the same period last year[13] Equity and Assets - Total assets as of March 31, 2024, were €4,361,379 thousand, slightly up from €4,357,396 thousand at the end of 2023[28] - As of March 31, 2024, total equity stood at €2,895.01 million[32] - On March 31, 2023, total equity was €2,564.60 million, indicating growth in equity over the year[32] Strategic Collaborations - Strategic collaborations were established with BridGene Biosciences and Thermo Fisher Scientific to strengthen the oncology pipeline and CAR-T manufacturing capabilities[6] Other Financial Metrics - Basic and diluted earnings per share for Q1 2024 were €1.37, compared to €0.35 in Q1 2023[26] - The company reported an operating loss of €33,131 thousand for Q1 2024, compared to a loss of €14,198 thousand in Q1 2023[26] - The company reported a share-based compensation of €4.97 million for the first quarter of 2024[34] - The company had a net sale of current financial investments amounting to €69.5 million during the first quarter of 2024[34] - Cash-out related to the sale of subsidiaries was €1.3 million[34] - The acquisition of financial assets held at fair value through profit or loss amounted to €36.9 million[34]

Mechelen, Belgium; 30 April 2024, 22:01 CET; Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today announces that all resolutions proposed at the company's Annual and Extraordinary Shareholders' Meetings (AGM and EGM) held on 30 April 2024 were approved. The AGM approved, amongst other items: The Remuneration Report and revised Remuneration PolicyThe remuneration of the members of the Board of DirectorsThe reappointment of Dr. Elisabeth Svanberg as Independent Non-Executive Director The appointments of Dr. Susan ...

Two oral presentations and one poster on encore preliminary data from Phase 1/2 CD19 CAR-T studies in non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) / Richter transformation (RT) Mechelen, Belgium; 4 April 2024, 22:01 CET – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today announced that four abstracts, including two oral presentations on encore preliminary clinical and translational data for its seven-day vein-to-vein CAR-T product candidates GLPG5101 and GLPG5201, will be presented at th ...