\n\u2013 Enrollment of Phase 3 MANIFEST-2 study of pelabresib in first-line myelofibrosis is complete, with topline data expected by the end of 2023<\/i><\/p>\n
\n\u2013 Enrollment of Phase 3 frontMIND study of tafasitamab in first-line diffuse large B-cell lymphoma is complete<\/i><\/p>\n
\n\u2013 \u20ac 791.5 million in cash and other financial assets as of March 31, 2023<\/i>\u00a0<\/p>\n
Conference call and webcast (in English) tomorrow, May 04, 2023, at 2:00pm CEST (1:00pm BST\/8:00am EDT)<\/i><\/p>\n
PLANEGG\/MUNICH, Germany–(BUSINESS WIRE<\/a>)– \n\u201cWe had a strong first quarter, marked by numerous achievements. Most importantly, we completed enrollment of our Phase 3 MANIFEST-2 study of pelabresib in first-line myelofibrosis ahead of schedule. As a result, the topline data from the trial are now expected by the end of 2023, months earlier than previously anticipated,\u201d said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. \u201cWe continue to focus our work on our most-advanced clinical programs that have the potential to create near-term value for all stakeholders. We look forward to building on this great momentum in 2023 and the years ahead.\u201d<\/p>\n Monjuvi\/Minjuvi<\/span>\u00ae<\/sup> Highlights:<\/span><\/b><\/p>\n Monjuvi (tafasitamab-cxix) U.S. net product sales<\/b> of US$ 20.8 million (\u20ac 19.4 million) for the first quarter 2023 (Q1 2022: US$ 18.7 million (\u20ac 16.6 million)).<\/p>\n Minjuvi royalty revenue<\/b> of \u20ac 0.7 million for sales outside of the U.S. in the first quarter 2023 (Q1 2022: \u20ac 0.7 million).<\/p>\n Corporate Developments:<\/span><\/b><\/p>\n \nOn March 2, 2023, MorphoSys announced that it will stop work and operations on its pre-clinical research programs to optimize its cost structure. MorphoSys reduced its workforce at the company\u2019s headquarters in Planegg, Germany, by approximately 17%. This action, along with other steps taken over the past year, enables MorphoSys to focus resources on its mid- to late-stage oncology pipeline.<\/p>\n \nOn March 14, 2023, MorphoSys announced that Lucinda Crabtree, Ph.D., will join the company as its Chief Financial Officer and member of the Management Board in the third quarter of 2023 at the latest.<\/p>\n \nCharlotte Lohmann was appointed as Chief Legal Officer on March 1, 2023 and will serve as a member of MorphoSys\u2019 Management Board ad interim.<\/p>\n \nOn March 30, 2023, MorphoSys settled the repurchase of bonds in the value of \u20ac 62.9 million (approximately 19 % of the outstanding principal amount) resulting in an outstanding aggregate principal amount of the convertible bonds of \u20ac 262.1 million.<\/p>\n Significant Events After the End of the First Quarter of 2023:<\/span><\/b><\/p>\n Pelabresib: Tafasitamab: Conference Data Highlight: \nNew data on pelabresib in essential thrombocythemia and tulmimetostat in a broad array of advanced tumors will be featured in two poster presentations during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.<\/p>\n Financial Results for the First Quarter of 2023 (IFRS):<\/span><\/b><\/p>\n Total revenues<\/b> for the first quarter 2023 were \u20ac 62.3 million compared to \u20ac 41.5 million for the same period in 2022. This increase resulted mainly from higher revenues from the sale of clinical vials.<\/p>\n
\nMorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the first quarter of 2023<\/i>.<\/p>\n
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<\/b>On April 4, 2023, MorphoSys announced that enrollment is complete for MANIFEST-2, the ongoing Phase 3 study exploring the efficacy and safety of pelabresib, an investigational BET inhibitor, in combination with ruxolitinib versus ruxolitinib alone in patients with myelofibrosis who have not previously been treated with a JAK inhibitor (JAK inhibitor-na\u00efve). More than 400 patients were enrolled in this study. The topline data are now expected by the end of 2023, earlier than previously anticipated.<\/p>\n
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<\/b>On April 4, 2023, MorphoSys announced that enrollment of the Phase 3 front<\/i>MIND study is also complete, with more than 880 patients enrolled in the trial. front<\/i>MIND is a global, multicenter, randomized, double-blind, placebo-controlled trial exploring tafasitamab, marketed in the U.S. as Monjuvi and outside the U.S. by Incyte as Minjuvi, plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP alone as a first-line treatment for high-intermediate and high-risk patients with diffuse large B-cell lymphoma (DLBCL). The topline data from this study are expected in the second half of 2025.<\/p>\n
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<\/b>On April 16, 2023, MorphoSys and Incyte announced final five-year follow-up data from the Phase 2 L-MIND study showing that Monjuvi (tafasitamab-cxix) plus lenalidomide followed by Monjuvi monotherapy provided prolonged, durable responses in adult patients with relapsed or refractory DLBCL. These data were featured as a late-breaking oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023.<\/p>\n
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