Missfresh Announces Entry of Share Purchase Agreements for Financing and Business Acquisition
- BEIJING, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Missfresh Limited (“Missfresh” or the “Company”) (NASDAQ: MF), today announced that it entered into two share purchase agreements with two investors, respectively (the “Share Purchase Agreements for Financing”), and another share purchase agreement with Mejoy Infinite Limited and its shareholder (the “Share Purchase Agreement for Business Acquisition”). The entry of the Share Purchase Agreements for Financing and the Share Purchase Agreement for Business Acquisition and the transactions contemplated thereunder have been approved by the board of directors of the Company (the “Board”) and the special committee under the Board.
- 08/03/2023
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Missfresh Announces Receipt of Nasdaq Notice of Market Value of Publicly Held Shares Deficiency
- BEIJING, July 10, 2023 (GLOBE NEWSWIRE) -- Missfresh Limited (NASDAQ: MF) (“Missfresh” or the “Company”) today announced that it has received written notification from the staff of the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) dated July 3, 2023, indicating that for the last 30 consecutive business days, the market value of publicly held shares (“MVPHS”) of the Company was below the minimum amount of US$5,000,000 set forth in Nasdaq Listing Rule 5450(b)(1)(C).
- 07/10/2023
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Bristol Myers Squibb to Highlight Diversified Approaches and Commitment to Improving Outcomes for Patients with Cancer and Serious Blood Disorders at ASCO, EHA and ICML 2023
- PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, the European Hematology Association (EHA) Congress, and the International Conference on Malignant Lymphoma (ICML), underscoring the company’s momentum towards delivering treatment options with the hope to transform clinical outcomes for patients. Data from more than 160 company-sponsored studies, investigator-sponsored studies and collaborations evaluating compounds spanning 20 cancer types and serious blood disorders will be featured across the three meetings, including the COMMANDS study, which has been selected for the official ASCO press program (Abstract #7003) and EHA plenary session (Abstract #S102). “We look forward to sharing our research during ASCO, EHA and ICML, demonstrating the diversity of our assets, cutting-edge pipeline, and science-driven strategy focused on shaping the next generation of cancer care,” said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. “The breadth of data and results illustrate how we are leveraging novel technologies to develop therapies that disrupt the course of disease for patients with solid tumors, blood cancers, and blood disorders. Positive study outcomes are critical, and so is ensuring those results represent and can benefit a diverse population of patients. Our health equity commitments are enabling inclusive innovation, better science and greater reach of our medicines to the patients who need them most.” Key data being presented by Bristol Myers Squibb at ASCO, EHA and ICML 2023 include: Hematology First disclosure of data from the Phase 3 COMMANDS study of Reblozyl (luspatercept-aamt) versus epoetin alfa, an erythropoiesis-stimulating agent (ESA), demonstrated highly statistically significant and clinically meaningful improvement in patients with anemia associated with very low- to intermediate-risk myelodysplastic syndromes, who require red blood cell (RBC) transfusions and are ESA-naïve. (ASCO/EHA) Preliminary results from the dose-escalation and expansion components of the Phase 1 CC-93269-MM-001 study demonstrate subcutaneous administration of bispecific T-cell engager alnuctamab exhibited promising dose-dependent anti-tumor activity in heavily pretreated multiple myeloma, with a high proportion of responders achieving minimal residual disease negativity. (EHA) Results from the dose-escalation components of a Phase 1/2 study evaluating BET inhibitor BMS-986158 as monotherapy and in combination with ruxolitinib or Inrebic (fedratinib), show generally manageable safety and robust spleen volume reduction in patients with intermediate- or high-risk myelofibrosis. (EHA) First disclosure of clinical data from a Phase 1b study evaluating golcadomide (CC-99282), a novel CELMoDTM agent, in combination with R-CHOP in patients with previously untreated aggressive B-cell lymphoma will be presented. (ICML) Results from a dose-expansion cohort of the Phase 1/2 CC-92480-MM-001 study, evaluating novel CELMoD agent, mezigdomide, with dexamethasone in patients with relapsed/refractory multiple myeloma, showed the combination’s safety profile and promising efficacy in patients with triple-class refractory multiple myeloma. (EHA) Cell Therapy First disclosure of data from the primary analysis of the TRANSCEND CLL 004 study of Breyanzi (lisocabtagene maraleucel) demonstrated deep and durable responses and a manageable safety profile, with no new safety signals, in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. (ASCO) Multiple analyses from the KarMMa-3 study showed improved health-related quality of life (HRQOL) and patient-reported outcomes, in addition to lower risk of disease progression, with Abecma (idecabtagene vicleucel), regardless of baseline high-risk disease or number of prior lines of therapy, in patients with triple-class exposed relapsed and refractory multiple myeloma. (ASCO/EHA) Interim results from Phase 1 study of GPRC5D CAR T (BMS-986393/CC-95266) demonstrated durable responses with an overall generally manageable safety profile, including in patients with prior BCMA-directed therapy. (EHA) Solid Tumor Results from the registrational TRIDENT-1 trial showed durable clinical activity with repotrectinib in ROS1 tyrosine kinase inhibitor (TKI)-naïve and TKI-pretreated patients with locally advanced or metastatic ROS1-positive NSCLC with or without baseline central nervous system metastases, including robust intracranial responses. (ASCO) Four-year data from the Phase 3 CheckMate -9LA trial reinforce durable, long-term survival with Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy for patients with metastatic NSCLC, including subgroups with higher unmet needs. (ASCO) Three-year results demonstrated long-term clinical benefit of neoadjuvant Opdivo with chemotherapy in patients with resectable NSCLC who received definitive surgery in the Phase 3 CheckMate -816 trial. (ASCO) Biomarker analyses from the Phase 3 CheckMate -76K trial support a potential clinical benefit of Opdivo for the adjuvant treatment of patients with stage IIB/C melanoma, across all biomarker sub-groups. (ASCO) Three-year data from the Phase 3 CheckMate -649 trial evaluating Opdivo plus chemotherapy continue to demonstrate durable long-term survival and HRQOL benefits in patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. (ASCO) Two-year data from the Phase 2/3 RELATIVITY-047 trial showed consistent benefit with the company’s third distinct checkpoint inhibitor Opdualag (nivolumab and relatlimab-rmbw) in patients with previously untreated metastatic or unresectable melanoma. (ASCO) Please see below for Important Safety Information and full Prescribing Information for Reblozyl, Opdualag, Opdivo, and Opdivo+Yervoy. Please see below for Important Safety Information and full Prescribing Information, including Boxed Warnings, for Abecma, Breyanzi and Inrebic. Investor Event Bristol Myers Squibb will host a virtual Investor Event on Tuesday, June 6, 2023, from 7:00-8:00 a.m. CT/8:00-9:00 a.m. ET to discuss data presented at ASCO. Company executives will provide an overview of data presented and address questions from investors and analysts. Investors and the general public are invited to listen to a live webcast of the event at http://investor.bms.com. An archived edition of the session will be available later that day. Summary of Presentations Select Bristol Myers Squibb studies at the 2023 ASCO Annual Meeting include: Abstract Title Author Presentation Type/# Session Title Session Date/Time (EDT) Acute Myeloid Leukemia Implications for acute myeloid leukemia (AML) treatment and care during the COVID-19 pandemic: A Connect Myeloid Registry study. Bart L. Scott Poster Abstract #7021 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Monday, June 5, 2023 9:00 AM – 12:00 PM Gastrointestinal First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) in patients (pts) with microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): 64-month (mo) follow-up from CheckMate 142. Heinz-Josef Lenz Poster Abstract #3550 Gastrointestinal Cancer—Colorectal and Anal Monday, June 5, 2023 9:00 AM – 12:00 PM Predictive value of tumor-infiltrating lymphocyte (TIL) dynamics in the tumor microenvironment (TME) during preoperative chemoradiotherapy (CRT) on pathologic complete response (pCR) in microsatellite-stable (MSS) locally advanced rectal cancer (LARC). Mitsuho Imai Poster Abstract #3608 Gastrointestinal Cancer—Colorectal and Anal Monday, June 5, 2023 9:00 AM – 12:00 PM Nivolumab (NIVO) plus chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 3-year follow-up from CheckMate 649. Yelena Y. Janjigian Poster Abstract #4025 Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Monday, June 5, 2023 9:00 AM – 12:00 PM Health-related quality of life (HRQOL) in patients (pts) with advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC): 36-month results of nivolumab plus chemotherapy (N+C) versus (C) from CheckMate 649. Elena Elimova Poster Abstract #4038 Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Monday, June 5, 2023 9:00 AM – 12:00 PM Genitourinary Health-related quality of life (HRQoL) of risk-based patient subgroups with advanced renal cell cancer (aRCC) treated with nivolumab plus cabozantinib (NIVO+CABO) vs sunitinib (SUN) in the CheckMate 9ER trial. David Cella Poster Abstract #4527 Genitourinary Cancer—Kidney and Bladder Saturday, June 3, 2023 9:00 AM – 12:00 PM Adjuvant nivolumab plus ipilimumab vs placebo for patients with localized renal cell carcinoma at high risk of relapse after nephrectomy: Subgroup analyses from the phase 3 CheckMate 914 (part A) trial. Robert J. Motzer Oral Abstract #4506 Genitourinary Cancer—Kidney and Bladder Monday, June 5, 2023 12:30 PM – 3:30PM Gynecologic Preliminary antitumor activity of the combination of COM701 + BMS-986207 + nivolumab in patients with recurrent, metastatic MSS endometrial cancer. Drew W. Rasco Poster Abstract #5595 Gynecologic Cancer Monday, June 5, 2023 2:15 PM – 5:15 PM Efficacy and final safety analysis of pre- and co-administration of nivolumab (Nivo) with concurrent chemoradiation (CCRT) followed by Nivo maintenance therapy in patients (pts) with locally advanced cervical carcinoma (LACvCa): Results from the phase I trial, GOTIC-018. Kazuto Nakamura Poster Abstract #5519 Gynecologic Cancer Monday, June 5, 2023 5:30 PM – 7:00 PM Preclinical testing of farletuzumab ecteribulin (FZEC [MORAb-202]) and MORAb-109, folate receptor α and mesothelin targeting antibody-drug conjugates (ADCs), in rare gynecologic cancers. Cassandra Vandenberg Publication Only Abstract #e17634 Gynecologic Cancer N/A Head & Neck A phase 2, open-label, multicenter study investigating efficacy and safety of RP3 oncolytic immunotherapy combined with other therapies in patients with locoregionally advanced or recurrent squamous cell carcinoma of the head and neck. Kevin Joseph Harrington Poster Abstract #TPS6106 Head and Neck Cancer Monday, June 5, 2023 2:15 PM – 5:15 PM Lymphoma Longitudinal, prospective cardiovascular and metabolic risk in treatment-naive patients with chronic myeloid leukemia in chronic phase (CML-CP) starting tyrosine kinase inhibitor (TKI) therapy in a real-world setting. Javid J. Moslehi Poster Abstract #7053 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Monday, June 5, 2023 9:00 AM – 12:00 PM Subgroup analyses of primary refractory (refr) vs early relapsed (rel) large B-cell lymphoma (LBCL) from the TRANSFORM study of lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) as second-line (2L) therapy. Loretta J. Nastoupil Poster Abstract #7526 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Monday, June 5, 2023 9:00 AM – 12:00 PM Response-adapted therapy (tx) with nivolumab plus brentuximab vedotin (nivo + BV) without autologous hematopoietic cell transplantation (auto-HCT) in children, adolescents, and young adults (CAYA) with low-risk relapsed/refractory (R/R) classic Hodgkin lymphoma (cHL): CheckMate 744. Paul David Harker-Murray Poster Abstract #7515 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Monday, June 5, 2023 2:15 PM – 3:45 PM Lisocabtagene maraleucel (liso-cel) in R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary analysis of TRANSCEND CLL 004. Tanya Siddiqi Oral Abstract #7501 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Tuesday, June 6, 2023 10:45 AM – 1:45 PM Melanoma The validity of a machine learning algorithm in predicting response to immune checkpoint inhibitors in melanoma. Faisal Fa’ak Poster Abstract #9523 Melanoma/Skin Cancers Saturday, June 3, 2023 2:15 PM – 5:15 PM Preliminary safety and efficacy results from an open-label, multicenter, phase 1 study of RP2 as a single agent and in combination with nivolumab in a cohort of patients with uveal melanoma. Joseph J. Sacco Poster Abstract #9527 Melanoma/Skin Cancers Saturday, June 3, 2023 2:15 PM – 5:15 PM Durable clinical outcomes in patients (pts) with advanced melanoma and progression-free survival (PFS) ≥3y on nivolumab (NIVO) ± ipilimumab (IPI) or IPI in CheckMate 067. F. Hodi Poster Abstract #9542 Melanoma/Skin Cancers Saturday, June 3, 2023 2:15 PM – 5:15 PM Efficacy and safety of first-line (1L) nivolumab plus relatlimab (NIVO + RELA) versus NIVO plus ipilimumab (NIVO + IPI) in advanced melanoma: An indirect treatment comparison (ITC) using patient-level data (PLD). Dirk Schadendorf Poster Abstract #9552 Melanoma/Skin Cancers Saturday, June 3, 2023 2:15 PM – 5:15 PM Association of circulating tumor DNA kinetics with disease recurrence in patients with stage IIB/C/IV melanoma treated with adjuvant immunotherapy in CheckMate 238. Mahrukh M. Syeda Poster Abstract #9577 Melanoma/Skin Cancers Saturday, June 3, 2023 2:15 PM – 5:15 PM Nivolumab (NIVO) plus relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: 2-year results from RELATIVITY-047. Hussein A. Tawbi Oral Abstract #9502 Melanoma/Skin Cancers Monday, June 5, 2023 4:00 PM – 7:00 PM Association of biomarkers (BMs) with efficacy of adjuvant nivolumab (NIVO) vs placebo (PBO) in patients with resected stage IIB/C melanoma (CA209 -76K). Georgina V. Long Oral Abstract #9504 Melanoma/Skin Cancers Monday, June 5, 2023 4:00 PM – 7:00 PM Merkel Cell Carcinoma Non-comparative, open-label, international, multicenter phase I/II study of nivolumab (NIVO) ± ipilimumab (IPI) in patients (pts) with recurrent/metastatic Merkel cell carcinoma (MCC) (CheckMate 358). Shailender Bhatia Oral Abstract #9506 Melanoma/Skin Cancers Monday, June 5, 2023 4:00 PM – 7:00 PM Multiple Myeloma Baseline and early post-infusion biomarkers associated with optimal response to idecabtagene vicleucel (ide-cel) in the KarMMa-3 study of triple-class–exposed (TCE) relapsed and refractory multiple myeloma (RRMM). Julia Piasecki Poster Abstract #8031 Hematologic Malignancies—Plasma Cell Dyscrasia Monday, June 5, 2023 9:00 AM – 12:00 PM Health related quality of life (HRQoL) in patients with triple-class-exposed relapsed/refractory multiple myeloma (TCE RRMM) treated with idecabtagene vicleucel (ide-cel) versus standard regimens: Patient-reported outcomes (PROs) from KarMMa-3 phase 3 randomized controlled trial (RCT). Michel Delforge Poster Abstract #8032 Hematologic Malignancies—Plasma Cell Dyscrasia Monday, June 5, 2023 9:00 AM – 12:00 PM Tumor-intrinsic features associated with progression-free survival (PFS) in patients (pts) with relapsed and refractory multiple myeloma (RRMM) treated with idecabtagene vicleucel (ide-cel). Nicholas Strong Poster Abstract #8035 Hematologic Malignancies—Plasma Cell Dyscrasia Monday, June 5, 2023 9:00 AM – 12:00 PM EXCALIBER-RRMM: A phase 3, two-stage study of iberdomide, daratumumab, and dexamethasone (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in patients (pts) with relapsed/refractory multiple myeloma (RRMM). Sagar Lonial Poster Abstract #TPS8069 Hematologic Malignancies—Plasma Cell Dyscrasia Monday, June 5, 2023 9:00 AM – 12:00 PM A phase 3, two-stage, randomized study of mezigdomide, carfilzomib, and dexamethasone (MeziKd) versus carfilzomib and dexamethasone (Kd) in relapsed/refractory multiple myeloma (RRMM): SUCCESSOR-2. Paul G. Richardson Poster Abstract #TPS8070 Hematologic Malignancies—Plasma Cell Dyscrasia Monday, June 5, 2023 9:00 AM – 12:00 PM Myelodysplastic Syndrome Efficacy and safety results from the COMMANDS trial: A phase 3 study evaluating luspatercept vs epoetin alfa in erythropoiesis-stimulating agent (ESA)-‑naive transfusion-dependent (TD) patients (pts) with lower-‑risk myelodysplastic syndromes (LR-MDS). Guillermo Garcia-Manero Oral Abstract #7003 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Friday, June 2, 2023 2:00 PM – 5:00 PM Hematologic and transfusion outcomes in patients (pts) with lower-risk myelodysplastic syndromes (LR-MDS) receiving luspatercept: Real-world assessment in the community practice setting. Sudipto Mukherjee Poster Abstract #7057 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Monday, June 5, 2023 9:00 AM – 12:00 PM Clinical outcomes by SF3B1 mutation status in patients (pts) with lower-risk myelodysplastic syndrome (LR-MDS) retreated with erythropoiesis-stimulating agents (ESAs). Adeola Y. Makinde Poster Abstract #7071 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Monday, June 5, 2023 9:00 AM – 12:00 PM A phase 2/3 trial of oral azacitidine (Oral-AZA) in patients (pts) with low- or intermediate-risk myelodysplastic syndromes (MDS). Guillermo Garcia-Manero Poster Abstract #TPS7083 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Monday, June 5, 2023 9:00 AM – 12:00 PM Myelofibrosis Safety and efficacy of luspatercept for the treatment of anemia in patients with myelofibrosis: Results from the ACE-536-MF-001 study. Aaron Thomas Gerds Poster Abstract #7016 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Monday, June 5, 2023 12:30 PM – 2:00 PM Thoracic Phase 2 small cell lung cancer (SCLC) cohort of a phase 1b/2 trial of a liposomal formulation of eribulin in combination with nivolumab. Koichi Azuma Poster Abstract #8593 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Sunday, June 4, 2023 9:00 AM – 12:00 PM Clinical outcomes with neoadjuvant nivolumab (N) + chemotherapy (C) vs C by definitive surgery in patients (pts) with resectable NSCLC: 3-y results from the phase 3 CheckMate 816 trial. Jonathan Spicer Poster Abstract #8521 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Sunday, June 4, 2023 12:30 PM – 2:00 PM Intracranial and systemic efficacy of repotrectinib in advanced ROS1 fusion-positive (ROS1+) non-small cell lung cancer (NSCLC) and central nervous system metastases (CNS mets) in the phase 1/2 TRIDENT-1. Jessica Jiyeong Lin Poster Abstract #9017 Lung Cancer—Non-Small Cell Metastatic Sunday, June 4, 2023 5:30 PM – 7:00 PM First-line (1L) nivolumab (N) + ipilimumab (I) + chemotherapy (C) vs C alone in patients (pts) with metastatic NSCLC (mNSCLC) from CheckMate 9LA: 4‑y clinical update and outcomes by tumor histologic subtype (THS). David Paul Carbone Poster Abstract #LBA9023 Lung Cancer—Non-Small Cell Metastatic Sunday, June 4, 2023 5:30 PM – 7:00 PM All abstracts except late-breaking abstracts will be available on the ASCO website at 5:00 PM EDT on Thursday, May 25. All late-breaking abstracts will be available on the ASCO website at 8:00 AM EDT on the day of the scientific session for the abstract presentation. Select Bristol Myers Squibb studies at the 2023 EHA Congress include: Abstract Title Author Presentation Type/# Session Date/ Time (EDT) Acute Myeloid Leukemia Longitudinal characterization of molecular variants at remission and relapse: subanalyisis of the QUAZAR AML-001 trial. Andrew Wei Poster Abstract #P411 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Disease monitoring of NPM1-mutant (mut) acute myeloid leukemia (AML) using measurable residual disease (MRD) assessments during oral azacitidine (oral-AZA) treatment (tx): a QUAZAR AML-001 subanalysis. Gail Roboz Poster Abstract #P459 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) A real-world evaluation of treatment patterns and outcomes of acute myeloid leukemia induction therapies in the community setting. Keri Maher Poster Abstract #P515 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Phase 1b OMNIVERSE trial: Safety and tolerability of oral azacitidine in combination with venetoclax for treatment of acute myeloid leukemia. Shaun Fleming Poster Abstract #P567 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Real-world characteristics and use of antiemetic therapies among patients with acute myeloid leukemia treated with oral azacitidine maintenance therapy. Ying Qui Poster Abstract #P587 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Implications of registry data for acute myeloid leukemia (AML) treatment and care during the COVID-19 pandemic. John Kelly Poster Abstract #P589 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Beta Thalassemia Effect of luspatercept on bone mineral density in patients with beta-thalassemia enrolled in the phase 3 BELIEVE trial. Thomas D. Coates Poster Abstract #P1466 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Long-term erythroid response data from patients (pts) with non-transfusion-dependent beta-thalassemia (NTDT) receiving luspatercept in the BEYOND trial. Ali T. Taher Oral Abstract #S273 Sunday, June 11, 2023 5:30 – 6:45 AM (11:30 AM – 12:45 PM CEST) Alpha Thalassemia Trial in Progress: A phase 2, double-blind, randomized, placebo-controlled, multicenter study to evaluate the efficacy and safety of luspatercept to treat anemia in adults with alpha-thalassemia. Vip Viprakasit Abstract only publication Abstract #PB2535 N/A Lymphoma Economic burden in chronic lymphocytic leukemia (CLL) for patients with ≥2 prior lines of therapy including a bruton tyrosine kinase inhibitor (BTKi) and/or B-cell lymphoma 2 inhibitor (BCL2i). Farrukh Awan Poster Abstract #P1696 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Qualitative interviews to describe burden in patients (pt) with third-line or later CLL/SLL with prior exposure to bruton tyrosine kinase inhibitor (BTKi) and/or B-cell lymphoma 2 inhibitor (BCL2i). Mona L Martin Abstract only publication Abstract #PB2696 N/A Multiple Myeloma Synergistic antitumor activity of the BCMA 2+1 T cell engager (TCE) alnuctamab (ALNUC; BMS-986349; CC-93269) and CELMoD agents in multiple myeloma (MM) preclinical models. Bruno Paiva Poster Abstract #P799 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Baseline and early post-infusion biomarkers associated with optimal response to idecabtagene vicleucel (ide-cel) in the KarMMa-3 study of triple-class-exposed relapsed and refractory multiple myeloma. Marc S. Raab Poster Abstract #P801 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Baseline characteristics identifying patients with multiple myeloma treated with idecabtagene vicleucel (ide-cel; BB2121) who are at risk for severe/refractory inflammatory adverse events. Yi Lin Poster Abstract #P809 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Soluble factors correlated with cytokine release syndrome (CRS) with IV vs subcutaneous (SC) alnuctamab (ALNUC; BMS-986349; CC-93269) in patients with relapsed/refractory multiple myeloma (RRMM). Luciano Costa Poster Abstract #P825 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Saloman Manier Poster Abstract #P866 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Mezigdomide (MEZI) plus dexamethasone (DEX) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): results from the dose-expansion phase of the CC-92480-MM-001 trial. Nizar J. Bahlis Poster Abstract #P868 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Idecabtagene vicleucel (ide-cel) in patients with an inadequate response to frontline autologous stem cell transplantation (ASCT): results from KarMMa-2 cohort 2c. Melissa Alsina Poster Abstract #P871 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Pomalidomide, daratumumab, and dexamethasone after lenalidomide treatment in patients with relapsed or refractory multiple myeloma (RRMM): final overall survival analysis of the phase 2 MM-014 study. Nizar J. Bahlis Poster Abstract #P882 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Alnuctamab (ALNUC; BMS-986349; CC-93269), a BCMA × CD3 T-cell engager, in patients (pts) with relapsed/refractory multiple myeloma (RRMM): latest results from a phase 1 first-in-human clinical study. Sandy W. Wong Poster Abstract #P883 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Patient reported outcomes in triple class exposed, relapsed/refractory multiple myeloma (TCE RRMM) patients in KarMMa-3 trial (phase 3 RCT): idecabtagene vicleucel (ide-cel) versus standard regimens. Michel Delforge Poster Abstract #P905 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Treatment patterns and clinical outcomes of patients with multiple myeloma previously treated with lenalidomide and an anti-CD38 monoclonal antibody: findings from the Connect® MM disease registry. Rafat Abonour Poster Abstract #P915 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Real-world clinical outcomes among triple-class exposed relapsed refractory multiple myeloma patients in US and Europe: PREAMBLE registry study. Hartmut Goldschmidt Poster Abstract #P945 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) BMS-986393 (CC-95266), a G protein–coupled receptor class C group five member D (GPRC5D)–targeted CAR T-cell therapy for relapsed/refractory multiple myeloma (RRMM): Results from a phase 1 study. Susan Bal Oral Abstract #S193 Saturday, June 10, 2023 5:30 – 6:45 AM (11:30 AM – 12:45 PM CEST) Idecabtagene vicleucel (ide-cel) vs standard regimens in patients with triple-class–exposed (tce) relapsed and refractory multiple myeloma (rrmm): a KarMMa-3 analysis in high-risk subgroups. Krina Patel Oral Abstract #S195 Saturday, June 10, 2023 10:30 – 11:45 AM (4:30 – 5:45 PM CEST) Elotuzumab or daratumumab in combination with pomalidomide and dexamethasone (EPd and DPd) in relapsed refractory multiple myeloma (RRMM): a network meta-analysis. Adriana Cury Abstract only publication Abstract #PB2095 N/A Myelodysplastic Syndromes Luspatercept versus epoetin alfa for treatment (TX) of anemia in ESA-naïve patients with lower-risk myelodysplastic syndromes(LR-MDS) patients (PTS) requiring RBC transfusions: data from the COMMANDS study. Matteo Giovanni Della Porta Oral plenary and special session Abstract #S102 Saturday, June 10, 2023 8:45 – 10:15 AM (2:45 – 4:15 PM CEST) Luspatercept restores effective erythropoiesis and provides superior and sustained benefit vs epoetin alfa: biomarker analysis from the phase 3 COMMANDS study. Uwe Platzbecker Poster Abstract #P693 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Distinct splicing alternations associated with clinical response to luspatercept in patients with lower-risk myelodysplastic syndromes from the MEDALIST study. Amit Verma Poster Abstract #P697 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Treatment patterns and outcomes among patients with lower-risk myelodysplastic syndromes receiving luspatercept in routine clinical practice in the United States. Sudipto Mukherjee Poster Abstract #P733 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) First-line treatment patterns and outcomes among patients with the newly diagnosed myelodysplastic syndromes: a global, retrospective observational cohort study. Amer M. Zeidan Abstract only publication Abstract #PB2010 N/A Myelofibrosis Efficacy and safety of luspatercept for the treatment of anemia in patients with myelofibrosis: results from the ACE-536-MF-001 Study. Francesco Passamonti Oral Abstract #S167 Friday, June 9, 2023 8:45 – 10:00 AM (2:45 – 4:00 PM CEST) Fedratinib is effective in ruxolitinib-resistant cells: clinical and preclinical correlations. Vikas Gupta Poster Abstract #P997 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) Real-world treatment patterns and healthcare resource utilization in myelofibrosis patients with anemia. John Mascarenhas Poster Abstract #P1059 Friday, June 9, 2023 12:00 – 1:00 PM (6:00 – 7:00 PM CEST) BMS-986158, a potent BET inhibitor, as monotherapy and in combination with ruxolitinib or fedratinib in intermediate- or high-risk myelofibrosis (MF): results from a phase 1/2 study. Haifa Kathrin Al-Ali Oral Abstract #S213 Saturday, June 10, 2023 All EHA abstracts except late-breaking abstracts will be available on May 11. All late-breaking abstracts will be available on June 1. Select Bristol Myers Squibb studies at the 2023 ICML Annual Meeting include: Abstract Title Author Presentation Type/# Session Title Session Date/ Time (EDT) Non-Hodgkin Lymphoma CC-99282 plus R-CHOP in patients (pts) with previously untreated aggressive B-cell lymphoma (aBCL): early safety and efficacy results from a phase 1b study. Javier Munoz Poster Abstract #438 Phase I-II Wednesday, June 14, 2023 6:00AM – 12:00 PM (12:00 – 6:00 PM CEST) Thursday, June 15 – Friday, June 16, 2023 4:00 AM – 12:00 PM (10:00 AM – 6:00 PM CEST) Open-label phase 1/2 study of CC-99282, a cereblon E3 ligase modulator (CELMoD) agent ± rituximab, in patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). Jean-Marie Michot Oral Abstract #90 Session 14 Novel Agents Saturday, June 17, 2023 2:45 – 4:15 AM (9:45 – 10:15 AM CEST) Chronic Lymphocytic Leukemia Health-related quality of life in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with liso-cel in TRANSCEND CLL 004. S.S. Kenderian Poster Abstract #400 CAR-T (Cellular Therapies) Wednesday, June 14, 2023 6:00AM – 12:00 PM (12:00 – 6:00 PM CEST) Thursday, June 15 – Friday, June 16, 2023 4:00 AM – 12:00 PM (10:00 AM ‒ 6:00 PM CEST) Lisocabtagene maraleucel (liso-cel) in R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): primary analysis of TRANSCEND CLL 004. Tanya Siddiqi Oral Abstract #26 Session 4 CLL and Richter Syndrome Thursday, June 15, 2023 7:45 – 9:15 AM (1:45 – 3:15 PM CEST) Large B Cell Lymphoma Comparison of overall survival of lisocabtagene maraleucel (liso-cel) versus standard of care (SOC) adjusting for crossover in second-line (2L) R/R large B-cell lymphoma. Franck Morschhauser Poster Abstract #332 DLBCL Wednesday, June 14, 2023 6:00AM – 12:00 PM (12:00 – 6:00 PM CEST) Thursday, June 15 – Friday, June 16, 2023 4:00 AM – 12:00 PM (10:00 AM – 6:00 PM CEST) Lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) as second-line therapy in large B-cell lymphoma (TRANSFORM study): Subgroup analyses by prior therapy response. Loretta J. Nastoupil Oral Abstract #138 Session 8 “Focus on...” Large B-Cell and Double Hit Lymphomas Thursday, June 15 11:00 AM – 12:00 PM (5:00 ‒ 6:00 PM CEST) All ICML accepted abstracts (except encore abstracts) will be available on June 9. Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. Learn more about the science behind cell therapy and ongoing research at Bristol Myers Squibb here. REBLOZYL INDICATIONS REBLOZYL is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. REBLOZYL is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate- risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN- RS-T). REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Thrombosis/Thromboembolism In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) of REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly. Hypertension Hypertension was reported in 10.7% (61/571) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 1.8% to 8.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In adult patients with MDS with normal baseline blood pressure, 26 (29.9%) patients developed SBP ≥130 mm Hg and 23 (16.4%) patients developed DBP ≥80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents. Extramedullary Hematopoietic Masses In adult patients with transfusion-dependent beta thalassemia, EMH masses were observed in 3.2% of REBLOZYL-treated patients, with spinal cord compression symptoms due to EMH masses occurring in 1.9% of patients (BELIEVE and REBLOZYL long-term follow-up study). In a study of adult patients with non-transfusion-dependent beta thalassemia, a higher incidence of EMH masses was observed in 6.3% of REBLOZYL-treated patients vs. 2% of placebo-treated patients in the double-blind phase of the study, with spinal cord compression due to EMH masses occurring in 1 patient with a prior history of EMH. REBLOZYL is not indicated for use in patients with non-transfusion-dependent beta thalassemia. Possible risk factors for the development of EMH masses in patients with beta thalassemia include history of EMH masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (2% included pneumonia and vomiting. No fatal adverse reactions occurred in patients who received OPDIVO in combination with platinum-doublet chemotherapy. In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 057, fatal adverse reactions occurred; these included events of infection (7 patients, including one case of Pneumocystis jirovecii pneumonia), pulmonary embolism (4 patients), and limbic encephalitis (1 patient). In Checkmate 743, serious adverse reactions occurred in 54% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism. Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY (n=547). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. In Checkmate 9ER, serious adverse reactions occurred in 48% of patients receiving OPDIVO and cabozantinib (n=320). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pneumonia, pneumonitis, pulmonary embolism, urinary tract infection, and hyponatremia. Fatal intestinal perforations occurred in 3 (0.9%) patients. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion- related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 274, serious adverse reactions occurred in 30% of patients receiving OPDIVO (n=351). The most frequent serious adverse reaction reported in ≥2% of patients receiving OPDIVO was urinary tract infection. Fatal adverse reactions occurred in 1% of patients; these included events of pneumonitis (0.6%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in ≥2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 59% of patients receiving OPDIVO with YERVOY (n=49). Serious adverse reactions reported in ≥4% of patients were pyrexia, diarrhea, anemia, increased AST, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin, and pneumonitis. In Attraction-3, serious adverse reactions occurred in 38% of patients receiving OPDIVO (n=209). Serious adverse reactions reported in ≥2% of patients who received OPDIVO were pneumonia, esophageal fistula, interstitial lung disease, and pyrexia. The following fatal adverse reactions occurred in patients who received OPDIVO: interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%). In Checkmate 577, serious adverse reactions occurred in 33% of patients receiving OPDIVO (n=532). A serious adverse reaction reported in ≥2% of patients who received OPDIVO was pneumonitis. A fatal reaction of myocardial infarction occurred in one patient who received OPDIVO. In Checkmate 648, serious adverse reactions occurred in 62% of patients receiving OPDIVO in combination with chemotherapy (n=310). The most frequent serious adverse reactions reported in ≥2% of patients who received OPDIVO with chemotherapy were pneumonia (11%), dysphagia (7%), esophageal stenosis (2.9%), acute kidney injury (2.9%), and pyrexia (2.3%). Fatal adverse reactions occurred in 5 (1.6%) patients who received OPDIVO in combination with chemotherapy; these included pneumonitis, pneumatosis intestinalis, pneumonia, and acute kidney injury. In Checkmate 648, serious adverse reactions occurred in 69% of patients receiving OPDIVO in combination with YERVOY (n=322). The most frequent serious adverse reactions reported in ≥2% who received OPDIVO in combination with YERVOY were pneumonia (10%), pyrexia (4.3%), pneumonitis (4.0%), aspiration pneumonia (3.7%), dysphagia (3.7%), hepatic function abnormal (2.8%), decreased appetite (2.8%), adrenal insufficiency (2.5%), and dehydration (2.5%). Fatal adverse reactions occurred in 5 (1.6%) patients who received OPDIVO in combination with YERVOY; these included pneumonitis, interstitial lung disease, pulmonary embolism, and acute respiratory distress syndrome. In Checkmate 649, serious adverse reactions occurred in 52% of patients treated with OPDIVO in combination with chemotherapy (n=782). The most frequent serious adverse reactions reported in ≥2% of patients treated with OPDIVO in combination with chemotherapy were vomiting (3.7%), pneumonia (3.6%), anemia (3.6%), pyrexia (2.8%), diarrhea (2.7%), febrile neutropenia (2.6%), and pneumonitis (2.4%). Fatal adverse reactions occurred in 16 (2.0%) patients who were treated with OPDIVO in combination with chemotherapy; these included pneumonitis (4 patients), febrile neutropenia (2 patients), stroke (2 patients), gastrointestinal toxicity, intestinal mucositis, septic shock, pneumonia, infection, gastrointestinal bleeding, mesenteric vessel thrombosis, and disseminated intravascular coagulation. Common Adverse Reactions In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%). In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%). In Checkmate 816, the most common (>20%) adverse reactions in the OPDIVO plus chemotherapy arm (n=176) were nausea (38%), constipation (34%), fatigue (26%), decreased appetite (20%), and rash (20%). In Checkmate 227, the most common (≥20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%). In Checkmate 9LA, the most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%), and pruritus (21%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 743, the most common adverse reactions (≥20%) in patients receiving OPDIVO plus YERVOY were fatigue (43%), musculoskeletal pain (38%), rash (34%), diarrhea (32%), dyspnea (27%), nausea (24%), decreased appetite (24%), cough (23%), and pruritus (21%). In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) were fatigue (58%), rash (39%), diarrhea (38%), musculoskeletal pain (37%), pruritus (33%), nausea (30%), cough (28%), pyrexia (25%), arthralgia (23%), decreased appetite (21%), dyspnea (20%), and vomiting (20%). In Checkmate 9ER, the most common adverse reactions (≥20%) in patients receiving OPDIVO and cabozantinib (n=320) were diarrhea (64%), fatigue (51%), hepatotoxicity (44%), palmar-plantar erythrodysaesthesia syndrome (40%), stomatitis (37%), rash (36%), hypertension (36%), hypothyroidism (34%), musculoskeletal pain (33%), decreased appetite (28%), nausea (27%), dysgeusia (24%), abdominal pain (22%), cough (20%) and upper respiratory tract infection (20%). In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO (n=236) were cough (14%) and dyspnea (14%) at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In Checkmate 274, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=351) were rash (36%), fatigue (36%), diarrhea (30%), pruritus (30%), musculoskeletal pain (28%), and urinary tract infection (22%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO as a single agent (n=74), the most common adverse reactions (≥20%) were fatigue (54%), diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation (20%), and upper respiratory tract infection (20%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), the most common adverse reactions (≥20%) were fatigue (49%), diarrhea (45%), pyrexia (36%), musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%), rash (25%), decreased appetite (20%), and vomiting (20%). In Checkmate 040, the most common adverse reactions (≥20%) in patients receiving OPDIVO with YERVOY (n=49), were rash (53%), pruritus (53%), musculoskeletal pain (41%), diarrhea (39%), cough (37%),decreased appetite (35%), fatigue (27%), pyrexia (27%), abdominal pain (22%), headache (22%), nausea (20%), dizziness (20%), hypothyroidism (20%), and weight decreased (20%). In Attraction-3, the most common adverse reactions (≥20%) in OPDIVO-treated patients (n=209) were rash (22%) and decreased appetite (21%). In Checkmate 577, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=532) were fatigue (34%), diarrhea (29%), nausea (23%), rash (21%), musculoskeletal pain (21%), and cough (20%). In Checkmate 648, the most common adverse reactions (≥20%) in patients treated with OPDIVO in combination with chemotherapy (n=310) were nausea (65%), decreased appetite (51%), fatigue (47%), constipation (44%), stomatitis (44%), diarrhea (29%), and vomiting (23%). In Checkmate 648, the most common adverse reactions reported in ≥20% of patients treated with OPDIVO in combination with YERVOY were rash (31%), fatigue (28%), pyrexia (23%), nausea (22%), diarrhea (22%), and constipation (20%). In Checkmate 649, the most common adverse reactions (≥20%) in patients treated with OPDIVO in combination with chemotherapy (n=782) were peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), and musculoskeletal pain (20%). Please see US Full Prescribing Information for OPDIVO and YERVOY. INREBIC INDICATION INREBIC® (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). IMPORTANT SAFETY INFORMATION BOXED WARNING: ENCEPHALOPATHY INCLUDING WERNICKE’S Serious and fatal encephalopathy, including Wernicke’s, has occurred in patients treated with INREBIC. Wernicke’s encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize. WARNINGS AND PRECAUTIONS Encephalopathy, including Wernicke’s: Serious and fatal encephalopathy, including Wernicke’s encephalopathy, has occurred in INREBIC-treated patients. Serious cases were reported in 1.3% (8/608) of patients treated with INREBIC in clinical trials and 0.16% (1/608) of cases were fatal. Wernicke’s encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Signs and symptoms of Wernicke’s encephalopathy may include ataxia, mental status changes, and ophthalmoplegia (e.g., nystagmus, diplopia). Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including Wernicke’s, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize. Anemia: New or worsening Grade 3 anemia occurred in 34% of INREBIC-treated patients. The median time to onset of the first Grade 3 anemia was approximately 2 months, with 75% of cases occurring within 3 months. Mean hemoglobin levels reached nadir after 12 to 16 weeks with partial recovery and stabilization after 16 weeks. Red blood cell transfusions were received by 51% of INREBIC-treated patients and permanent discontinuation of INREBIC occurred due to anemia in 1% of patients. Consider dose reduction for patients who become red blood cell transfusion dependent. Thrombocytopenia: New or worsening Grade ≥3 thrombocytopenia during the randomized treatment period occurred in 12% of INREBIC-treated patients. The median time to onset of the first Grade 3 thrombocytopenia was approximately 1 month; with 75% of cases occurring within 4 months. Platelet transfusions were received by 3.1% of INREBIC-treated patients. Permanent discontinuation of treatment due to thrombocytopenia and bleeding that required clinical intervention both occurred in 2.1% of INREBIC-treated patients. Obtain a complete blood count (CBC) at baseline, periodically during treatment, and as clinically indicated. For Grade 3 thrombocytopenia with active bleeding or Grade 4 thrombocytopenia, interrupt INREBIC until resolved to less than or equal to Grade 2 or baseline. Restart dose at 100 mg daily below the last given dose and monitor platelets as clinically indicated. Gastrointestinal Toxicity: Gastrointestinal toxicities are the most frequent adverse reactions in INREBIC-treated patients. During the randomized treatment period, diarrhea occurred in 66% of patients, nausea in 62% of patients, and vomiting in 39% of patients. Grade 3 diarrhea 5% and vomiting 3.1% occurred. The median time to onset of any grade nausea, vomiting, and diarrhea was 1 day, with 75% of cases occurring within 2 weeks of treatment. Consider providing appropriate prophylactic anti-emetic therapy (e.g., 5-HT3 receptor antagonists) during INREBIC treatment. Treat diarrhea with anti-diarrheal medications promptly at the first onset of symptoms. Grade 3 or higher nausea, vomiting, or diarrhea not responsive to supportive measures within 48 hours, interrupt INREBIC until resolved to Grade 1 or less or baseline. Restart dose at 100 mg daily below the last given dose. Monitor thiamine levels and replete as needed. Hepatic Toxicity: Elevations of ALT and AST (all grades) during the randomized treatment period occurred in 43% and 40%, respectively, with Grade 3 or 4 in 1% and 0%, respectively, of INREBIC-treated patients. The median time to onset of any grade transaminase elevation was approximately 1 month, with 75% of cases occurring within 3 months. Monitor hepatic function at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher ALT and/or AST elevations (greater than 5 × ULN), interrupt INREBIC dose until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose. If re-occurrence of a Grade 3 or higher elevation of ALT/AST, discontinue treatment with INREBIC. Amylase and Lipase Elevation: Grade 3 or higher amylase 2% and/or lipase 10% elevations developed in INREBIC-treated patients. The median time to onset of any grade amylase or lipase elevation was 15 days, with 75% of cases occurring within 1 month of starting treatment. One patient developed pancreatitis in the fedratinib clinical development program (n=608) and pancreatitis resolved with treatment discontinuation. Monitor amylase and lipase at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher amylase and/or lipase elevations, interrupt INREBIC until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose. Major Adverse Cardiac Events (MACE): Another JAK inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. Consider the benefits and risks of the individual patients prior to initiating or continuing therapy with INREBIC, particularly in patients who are current or past smokers, or have other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and what to do if they occur. Thrombosis: Another JAK inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. In patients with MF treated with INREBIC in clinical trials, the rates of thromboembolic events were similar in INREBIC and placebo treated patients. Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately. Secondary Malignancies: Another JAK inhibitor has increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (NMSC) in patients with rheumatoid arthritis, a condition for which INREBIC is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with INREBIC, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers. ADVERSE REACTIONS The most common adverse reactions for INREBIC treated vs. placebo were diarrhea (66% vs. 16%), nausea (62% vs. 15%), anemia (40% vs. 14%), and vomiting (39% vs. 5%). Dosage interruptions due to an adverse reaction during the randomized treatment period occurred in 21% of patients who received INREBIC. Adverse reactions requiring dosage interruption in >3% of patients who received INREBIC included diarrhea and nausea. Dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received INREBIC. Adverse reactions requiring dosage reduction in >2% of patients who received INREBIC included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%). DRUG INTERACTIONS Coadministration of INREBIC with a strong CYP3A4 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Consider alternative therapies that do not strongly inhibit CYP3A4 activity. Alternatively, reduce the dose of INREBIC when administering with a strong CYP3A4 inhibitor. Avoid INREBIC with strong and moderate CYP3A4 inducers. Avoid INREBIC with dual CYP3A4 and CYP2C19 inhibitor. Coadministration of INREBIC with drugs that are CYP3A4 substrates, CYP2C19 substrates, or CYP2D6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs. Monitor for adverse reactions and adjust the dose of drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates as necessary when coadministered with INREBIC. PREGNANCY/LACTATION Consider the benefits and risks of INREBIC for the mother and possible risks to the fetus when prescribing INREBIC to a pregnant woman. Due to the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with INREBIC, and for at least 1 month after the last dose. RENAL IMPAIRMENT Reduce INREBIC dose when administered to patients with severe renal impairment. No modification of the starting dose is recommended for patients with mild to moderate renal impairment. Due to potential increase of exposure, patients with preexisting moderate renal impairment require more intensive safety monitoring, and if necessary, dose modifications based on adverse reactions. HEPATIC IMPAIRMENT Avoid use of INREBIC in patients with severe hepatic impairment. Please see full Prescribing Information, including Boxed WARNING, and Summary of Product Characteristics for INREBIC. ABECMA INDICATION ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. IMPORTANT SAFETY INFORMATION BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed. Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities. Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA. ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. Warnings and Precautions: Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA in 85% (108/127) of patients. Grade 3 or higher CRS occurred in 9% (12/127) of patients, with Grade 5 CRS reported in one (0.8%) patient. The median time to onset of CRS, any grade, was 1 day (range: 1 - 23 days) and the median duration of CRS was 7 days (range: 1 - 63 days). The most common manifestations included pyrexia, hypotension, tachycardia, chills, hypoxia, fatigue, and headache. Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, acute respiratory distress syndrome (ARDS), atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, multiple organ dysfunction syndrome, and HLH/MAS. Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS. Fifty four percent (68/127) of patients received tocilizumab (single dose: 35%; more than 1 dose: 18%). Overall, 15% (19/127) of patients received at least 1 dose of corticosteroids for treatment of CRS. All patients that received corticosteroids for CRS received tocilizumab. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA. Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of CRS and monitor patients for signs or symptoms of CRS for at least 4 weeks after ABECMA infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. Neurologic Toxicities: Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA in 28% (36/127) of patients receiving ABECMA, including Grade 3 in 4% (5/127) of patients. One patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff. The median time to onset of neurotoxicity was 2 days (range: 1 - 42 days). CAR T cell-associated neurotoxicity resolved in 92% (33/36) of patients with a median time to resolution of 5 days (range: 1 - 61 days). The median duration of neurotoxicity was 6 days (range: 1 - 578) in all patients including 3 patients with ongoing neurotoxicity. Thirty-four patients with neurotoxicity had CRS with onset in 3 patients before, 29 patients during, and 2 patients after CRS. The most frequently reported manifestations of CAR T cell-associated neurotoxicity include encephalopathy, tremor, aphasia, and delirium. Grade 4 neurotoxicity and cerebral edema in 1 patient, Grade 3 myelitis, and Grade 3 parkinsonism have been reported with ABECMA in another study in multiple myeloma. Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or
- 05/11/2023
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Geron Presentations at Upcoming EHA Annual Meeting to Report Updated Durability, Disease Modification and Favorable Patient Reported Outcomes (PRO) in Imetelstat-Treated Lower Risk MDS Patients in IMerge Phase 3
- FOSTER CITY, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that five abstracts related to imetelstat, a first-in-class telomerase inhibitor, have been accepted at the European Hematology Association (EHA) Annual Meeting taking place from June 8-11, 2023 in Frankfurt, Germany and virtually. The three EHA abstracts on IMerge Phase 3 data expand upon and further confirm the differentiating qualities of imetelstat that can address current unmet needs for lower risk MDS patients compared to available treatments. In addition, abstracts submitted by Geron collaborators covering a translational analysis from a subset of IMerge Phase 2 patients and imetelstat MF pre-clinical data were accepted for oral and poster presentation, respectively. “The longer follow-up data for one-year TI and additional analyses from IMerge Phase 3 in lower risk MDS we are presenting at EHA further confirm the unprecedented durability of imetelstat, as well as provide deeper insight into the clinically meaningful benefit/risk profile of imetelstat in these patients,” said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. “The strong correlation of reduction in MDS-associated mutations with clinical benefits observed in these patients provides strong evidence for the potential of disease modification with imetelstat. Further, patient reported outcomes presenting sustained meaningful improvement in fatigue is particularly important as fatigue is a specific concern for lower risk MDS patients, and because improvement in fatigue has not been seen with currently available treatments. Overall, as these analyses are completed and as the data continue to mature, a highly compelling and differentiated profile supporting strong clinical benefit is being reinforced for imetelstat in lower risk MDS.” IMerge Phase 3 Clinical Data – Lower Risk Myelodysplastic Syndromes (MDS) Abstract #S165: “Continuous Transfusion Independence with Imetelstat in Heavily Transfused Non-Del(5q) Lower Risk Myelodysplastic Syndromes Relapsed/Refractory to Erythropoiesis Stimulating Agents in IMerge Phase 3” Oral Presentation on June 9 in session s417 “MPN and MDS: Targeting red cells and platelets” (14:45-16:00 CEST) Presenter: Uwe Platzbecker, MD, University Hospital of Leipzig The abstract reports top-line results from IMerge Phase 3 with a data cut-off of October 2022 for the primary analysis and January 2023 for ≥1-yr transfusion independence (TI). As reported in January 2023, imetelstat demonstrated statistically significant and clinically meaningful efficacy with robust 8-week TI, 24-week TI, and 1-year TI rates. With 3 months additional follow-up, 17.8% (21/178) of imetelstat-treated patients versus 1.7% (1/60) of placebo-treated patients achieved 1-year TI (P = 0.002), representing 63.6% of 24-week TI imetelstat responders. The continuous TI for more than one year represents substantial relief from transfusion-associated complications for this lower risk MDS patient population. As reported in January, 39.8% (47/118) of imetelstat-treated patients versus 15.0% (9/60) of placebo-treated patients achieved the study primary endpoint of 8-week TI (P 80% resolved to Grade ≤2 within 4 weeks. The abstract also noted no new safety signals were identified in the trial. Abstract #S164: “Disease Modifying Activity of Imetelstat in Patients with Heavily Transfused Non-Del(5q) Lower-Risk Myelodysplastic Syndromes Relapsed/Refractory to Erythropoiesis Stimulating Agents in IMerge Phase 3” Oral Presentation on June 11th in session “s448 MDS biology and translational updates” (11:30 - 12:45 CEST) Presenter: Valeria Santini, MD, University of Florence School of Medicine As noted in the abstract, a main therapeutic goal in lower risk MDS is to alter disease biology by eradicating malignant clones. MDS-initiating cells carrying cytogenetic abnormalities, mutant alleles, or both and arise from malignant stem and progenitor cells. SF3B1, involved in RNA splicing, and TET2, involved in DNA methylation, are recurrently mutated genes in lower risk MDS., Measuring change in VAF of these genes is used to denote disease burden. Of the 178 patients enrolled in IMerge Phase 3, 22.0% of imetelstat-treated patients and 21.7% of placebo-treated patients had baseline cytogenetic abnormalities. Cytogenetic response was observed in 34.6% (9/26) of imetelstat treated patients (95% CI=17.2–55.7) versus 15.4% (2/13) of placebo-treated patients (95% CI=1.9–45.5). In addition, imetelstat-treated patients demonstrated a higher rate of ≥50% VAF decreases in SF3B1, TET2, DNMT3A, and ASXL1 mutations as compared with placebo. Imetelstat-treated patients achieving 8-week TI, 24-week TI, and 1-year TI had higher VAF reductions in SF3B1 and TET2 mutations compared with placebo-treated patients. Additionally, both 8-week TI and 24-week TI responders on imetelstat had significantly greater VAF reductions in SF3B1 mutation versus non-responders (P<0.001, for both) on imetelstat. Importantly, greater VAF reductions in SF3B1 mutation for imetelstat-treated patients correlated significantly with hemoglobin increase; r=−0.626 (P<0.001), and longer TI duration; r=−0.549 (P<0.001). The abstract concludes that these data, taken together with robust rates of TI that are continuous and durable in the trial, may indicate improvement of the ineffective erythropoiesis characteristic of lower risk MDS with imetelstat and suggest imetelstat may alter the underlying biology of disease in these patients. Abstract #P732: “Analysis of Patient Reported Fatigue in IMerge Phase 3 Trial of Imetelstat vs. Placebo in Heavily Transfused Non-Del(5q) Lower Risk Myelodysplastic Syndromes Relapsed/Refractory to Erythropoiesis Stimulating Agents (ESA)” Poster on June 9 at 18:00 - 19:00 CEST Presenter: Mikkael Sekeres, MD, University of Miami Health System and Sylvester Comprehensive Cancer Center The abstract noted that patients with lower risk MDS and anemia experience severe fatigue that negatively impacts overall functioning and daily life. The goals for lower risk MDS treatments are to minimize transfusions and improve patient-reported outcomes (PRO). However, fatigue can also be commonly reported with currently available treatments. In the trial, an exploratory analysis of patient-reported fatigue was conducted using Functional Assessment of Chronic Illness Therapy, or FACIT, a validated 13-item patient questionnaire, to measure the rate of deterioration or improvement of fatigue during treatment with imetelstat or placebo. Proportion of sustained meaningful deterioration/improvement was defined as percentage of patients with ≥3-point decrease/increase on the FACIT Fatigue Scale (0–52) for ≥2 consecutive treatment cycles. Time-to-deterioration/improvement was estimated by Kaplan-Meier analysis. 118 patients on imetelstat and 57 patients on placebo were assessed for PRO. Overall, 50.0% of imetelstat-treated patients reported sustained meaningful improvement in fatigue versus 40.4% of placebo-treated patients. In addition, imetelstat-treated patients reported a shorter median time to first sustained meaningful improvement in fatigue versus placebo-treated patients; 28.3 vs 65.0 weeks, respectively, hazard ratio=1.34 (95% CI, 0.82–2.20). After 12 weeks, more imetelstat-treated patients reported improvement in the FACIT Fatigue Scale than placebo-treated patients. In addition, in imetelstat-treated patients, a significantly higher proportion of TI responders had sustained meaningful improvement in fatigue scores versus non-responders. This was consistent across 8-week TI and 24-week TI and hematologic improvement-erythroid (HI-E) response per 2006 International Working Group criteria, for imetelstat-treated patients, which was not an association observed in placebo-treated patients. With both imetelstat- and placebo-treated patients reporting similar rates of deterioration in fatigue, these data suggest that imetelstat did not worsen the rate of deterioration, which has been reported with other available treatments. Importantly, imetelstat-treated patients were more likely to have sustained meaningful improvement in fatigue, as well as experience such improvement more quickly. The abstract concludes that a significant association between TI and HI-E responses and sustained meaningful improvement in fatigue support the clinical benefit of imetelstat treatment. Translational Analysis from IMerge Phase 2 – Lower Risk MDS Abstract #S169: “Modulation of the immune landscape in lower-risk myelodysplastic syndromes with imetelstat-induced transfusion independency” Oral Presentation on June 9 in session “s417 MPN and MDS: Targeting red cells and platelets” (14:45-16:00 CEST) Presenter: Nicolas Chapuis, Assistance Publique-Hopitaux de Paris, Centre-Universite Paris Cite As noted in an abstract by Geron collaborators, this analysis aimed to identify biological pathways associated with the clinical response, by analyzing bone marrow mononuclear cell transcriptome and peripheral blood immune cell landscape of a subset of patients with lower risk MDS enrolled in the IMerge Phase 2 clinical trial. The abstract concludes that low inflammatory features at baseline and induction of an adaptive immune profile by imetelstat are associated with the TI response, suggesting that immune cell remodeling could contribute to hematopoietic activity of imetelstat treatment. Imetelstat Pre-Clinical Data in Myelofibrosis (MF) Abstract # P1008: “The telomerase inhibitor imetelstat differentially targets JAK2V617F- versus CALR-mutant Myeloproliferative Neoplasm cells and inhibits JAK-STAT signaling” Poster on Friday, June 9 at 18:00-19:00 CEST Presenter: Nicolas Chatain, PhD, University Hospital Aachen An abstract by Geron collaborators reports on a single patient study which analyzed clonal evolution of the myeloproliferative neoplasms mutation profile during a two-year course of imetelstat treatment. In the study, using the human TF-1MPL and murine 32DMPL cell lines, the authors demonstrated a stronger effect of imetelstat on CALRdel52-positive vs. JAK2V617F-positive cell viability (p=0.0361 and p=0.0311 for 5 μM imetelstat, respectively), and this was associated with an immediate downregulation of JAK2 protein phosphorylation and downstream signaling as well as a reduction of telomerase reverse transcriptase (hTERT) and STAT3 mRNA expression. The authors report these data confirm that imetelstat reduces hTERT expression and telomere length (TL) and JAK2 and CALR clones by targeting the JAK/STAT signaling, particularly in CALR-mutated cells. According to the abstract conclusion, the data propose that CALR-mutated clones are highly vulnerable to imetelstat treatment. About IMerge Phase 3 The Phase 3 portion of the IMerge Phase 2/3 study is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower risk) transfusion dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a HMA or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of RBC-TI lasting at least eight weeks, defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week TI), the duration of TI and the rate of hematologic improvement erythroid (HI-E), which is defined as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across North America, Europe, Middle East and Asia. About Imetelstat Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment. Geron plans to submit a New Drug Application (NDA) in the U.S. in June 2023 and a Marketing Authorization Application (MAA) in the EU in the second half of 2023 in the lower risk MDS indication. About Geron Geron is a late-stage biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. Our first-in-class telomerase inhibitor, imetelstat, harnesses Nobel Prize-winning science in a treatment that may alter the underlying drivers of disease. Geron currently has two Phase 3 pivotal clinical trials underway evaluating imetelstat in lower risk myelodysplastic syndromes (LR MDS), and in relapsed/refractory myelofibrosis (MF). To learn more, visit www.geron.com or follow us on LinkedIn. Use of Forward-Looking Statements Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) that for IMerge Phase 3, Geron plans to submit a New Drug Application in the U.S. in June 2023 and a Marketing Authorization Application in the EU in the second half of 2023; (ii) that imetelstat has the potential to demonstrate disease-modifying activity in patients; and (iii) other statements that are not historical facts, constitute forward-looking statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) whether the current or evolving effects of the COVID-19 pandemic and/or geopolitical events and resulting global economic and financial disruptions will materially and adversely impact Geron’s business and business prospects, its financial condition and the future of imetelstat; (b) whether Geron overcomes all of the potential delays and other adverse impacts caused by the current or evolving effects of the COVID-19 pandemic and/or geopolitical events, as well as all the enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to have the financial resources for, and to meet the expected timelines, planned milestones and expenses; (c) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (d) whether imetelstat has demonstrated sufficient safety, efficacy and clinical benefit in IMerge Phase 3 to enable regulatory approval; (e) whether any future safety or efficacy results cause the benefit-risk profile of imetelstat to become unacceptable; (f) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (g) that Geron may seek to raise substantial additional capital in order to complete the development and commercialization of imetelstat to meet the expected timelines, planned milestones and expenses; (h) whether there are failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials that impact a commercial launch in lower risk MDS; (i) whether the follow-up period of 12 months for the IMerge Phase 3 primary analysis was sufficient to demonstrate safety and efficacy, including transfusion independence and clinical benefit, and obtain regulatory approval; and (j) for IMerge Phase 3, the FDA may require Geron to submit additional information or require advisory committee procedures that could cause a regulatory approval, if any, to be delayed. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s quarterly report on Form 10-Q for the quarter ended March 31, 2023 and future filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
- 05/11/2023
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Geron Corporation Reports First Quarter 2023 Financial Results and Business Highlights
- FOSTER CITY, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business updates and financial results for the first quarter of 2023. “We believe that imetelstat has a compelling commercial value proposition and is well-positioned to become a standard of care in lower risk MDS, based on unprecedented broad durability of transfusion independence in the IMerge Phase 3 trial and high unmet need in this patient population,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We are on track to submit a New Drug Application in the U.S. next month and are preparing for a potential U.S. commercial launch in the first half of 2024. Further, we are planning to submit a Marketing Authorization Application in the EU in the second half of 2023 and preparing for an EU commercial launch by the end of 2024.” Dr. Scarlett also noted, “We also continue to make progress on recruiting and enrolling patients into IMpactMF, the first and only Phase 3 study of JAK inhibitor relapsed/refractory myelofibrosis patients with a primary endpoint of overall survival. If this trial is successful, we expect imetelstat to become a transformational agent for these patients.” Dr. Scarlett added, “As of the end of the quarter, we had over $400 million on the balance sheet, which we believe provides the financial resources to operate the company through the end of the third quarter of 2025. This means we expect to launch in lower risk MDS without being compromised by lack of funding, while also supporting IMpactMF and our other ongoing earlier stage programs.” Financial Resources to Support Potential Commercial Launch of Imetelstat in Lower Risk Myelodysplastic Syndromes (MDS) As of March 31, 2023, the Company had $409.2 million in cash and marketable securities. In January 2023, the Company closed an underwritten public offering of common stock and pre-funded warrant, plus the full exercise of the underwriters’ option to purchase additional shares of common stock, for net cash proceeds of $213.3 million, after deducting the underwriting discount and other offering expenses. In addition, the Company received $59.8 million upon the cash exercise of outstanding warrants in the first quarter of 2023. Based on the Company’s current operating plans and expectations regarding the timing of regulatory approval and commercialization of imetelstat in the United States (U.S.) in the first half of 2024, Geron projects that its existing financial resources will be sufficient to fund its projected operating requirements through the end of the third quarter of 2025. First Quarter 2023 Financial Results For the first quarter of 2023, the Company reported a net loss of $38.1 million, or $0.07 per share, compared to $30.1 million, or $0.09 per share, for the first quarter of 2022. Revenues for the first quarter of 2023 were $21,000 compared to $123,000 for the same period in 2022. Royalty revenues in 2023 and 2022 primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets. Total operating expenses for the first quarter of 2023 were $40.1 million, compared to $28.8 million for the same period in 2022. Research and development expenses for the first quarter of 2023 were $27.2 million, compared to $22.1 million for the same period in 2022. The increase in research and development expenses for the three months ended March 31, 2023, compared to the same period in 2022, primarily reflects higher clinical trial costs related to supporting IMerge Phase 3 and IMpactMF and increased personnel-related expenses for additional headcount. General and administrative expenses for the first quarter of 2023 were $12.9 million compared to $6.7 million for the same period in 2022. The increase in general and administrative expenses for the three months ended March 31, 2023, compared to the same period in 2022, primarily reflects new costs for commercial preparatory activities and higher personnel-related expenses for additional headcount. Interest income for the first quarter of 2023 was $3.9 million, compared to $112,000 for the same period in 2022. The increase in interest income for the three months ended March 31, 2023, compared to the same period in 2022, primarily reflects higher yields on the Company’s marketable securities as a result of rising interest rates, as well as a larger investment portfolio with the cash proceeds from the January 2023 offering and warrant exercises in the first quarter of 2023. Interest expense for the first quarter of 2023 was $1.9 million, compared to $1.5 million for the same period in 2022. The increase in interest expense for the three months ended March 31, 2023, compared to the same period in 2022, primarily reflects higher interest rates. Under the terms of the loan agreement, the interest-only payment period was extended by 12 months from April 2023 to April 2024 as a result of achieving positive top-line results from IMerge Phase 3 in January 2023. Currently, the Company has $50.0 million in principal debt outstanding. Projected 2023 Financial Guidance Reaffirmed For fiscal year 2023, under generally accepted accounting principles (GAAP), the Company continues to expect total expenses in the range of approximately $210 million to $220 million, which includes non-cash items such as: stock-based compensation expense, amortization of debt discounts and issuance costs and depreciation and amortization. The Company expects non-GAAP total expenses for fiscal year 2023 to be in the range of approximately $200 million to $210 million. This guidance excludes estimated non-cash items such as: stock-based compensation expense, amortization of debt discounts and issuance costs, as well as depreciation and amortization. The fiscal year 2023 financial guidance reflects costs to support planned regulatory submissions in 2023; continued support of ongoing clinical trials, IMerge Phase 3, IMpactMF, IMproveMF and IMpress, as well as preclinical studies in lymphoid malignancies and discovery research for a next generation telomerase inhibitor; manufacturing commercial inventory of imetelstat; preparations for potential U.S. commercial launch of imetelstat in lower risk MDS; projected increases in headcount and interest payments on outstanding debt. As of March 31, 2023, the Company had 120 employees. The Company plans to grow to a total of approximately 150 to 160 employees by year-end 2023. Conference Call Geron will host a conference call at 10:30 a.m. ET on Thursday, May 11, 2023 to discuss business updates, expected upcoming milestones and first quarter financial results. A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days. Participants may access the webcast by registering online using the following link, https://conferencingportals.com/event/SmvlMvWL. About Imetelstat Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment. About IMerge Phase 3 The Phase 3 portion of the IMerge Phase 2/3 study is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower risk) transfusion dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a HMA or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of RBC-TI lasting at least eight weeks, which is defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week TI), the duration of TI and the rate of hematologic improvement erythroid (HI-E), which is defined as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across North America, Europe, Middle East and Asia. About IMpactMF IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis (MF) who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete remission, partial remission, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes. IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156. About Geron Geron is a late-stage biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. The Company’s investigational first-in-class telomerase inhibitor, imetelstat, harnesses Nobel Prize-winning science in a treatment that may alter the underlying drivers of disease. Geron currently has a Phase 3 clinical trial underway evaluating imetelstat in each of: (i) lower risk myelodysplastic syndromes (LR MDS), and (ii) relapsed/refractory myelofibrosis (MF). To learn more, visit www.geron.com or follow us on LinkedIn. Use of Forward-Looking Statements Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) that for IMerge Phase 3, Geron plans: to submit a New Drug Application in the U.S. in June 2023 and a Marketing Authorization Application in the EU in the second half of 2023, and is preparing for a potential launch in lower risk MDS in the U.S. in the first half of 2024, and in the EU by the end of 2024; (ii) that imetelstat has the potential to demonstrate disease-modifying activity in patients; (iii) that for fiscal year 2023, under GAAP the Company expects total expenses to be in the range of $210 to $220 million, and non-GAAP total expenses to be in the range of $200 to $210 million; (iv) that the Company believes the over $400 million currently on the balance sheet provides the financial resources to operate the Company through the end of the third quarter of 2025; (v) that IMpactMF has registrational intent; and (vi) other statements that are not historical facts, constitute forward-looking statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) whether the current or evolving effects of the COVID-19 pandemic and/or geopolitical events and resulting global economic and financial disruptions will materially and adversely impact Geron’s business and business prospects, its financial condition and the future of imetelstat; (b) whether Geron overcomes all of the potential delays and other adverse impacts caused by the current or evolving effects of the COVID-19 pandemic and/or geopolitical events, as well as all the enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to have the financial resources for, and to meet the expected timelines, planned milestones and expenses in (i) and (iii) to (iv) above; (c) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (d) whether imetelstat has demonstrated sufficient safety and efficacy and clinical benefit in IMerge Phase 3 to enable regulatory approval; (e) whether any future safety or efficacy results cause the benefit-risk profile of imetelstat to become unacceptable; (f) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (g) that Geron may seek to raise substantial additional capital in order to complete the development and commercialization of imetelstat to meet the expected timelines, planned milestones and expenses in (i) and (iii) to (iv) above; (h) whether regulatory authorities require an additional imetelstat lower risk MDS clinical trial for approval, or post-approval; (i) whether there are failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials that impact a commercial launch in lower risk MDS or the IMpactMF trial; (j) whether the follow-up period of 12 months for the IMerge Phase 3 primary analysis was sufficient to demonstrate safety and efficacy, including transfusion independence and clinical benefit, and obtain regulatory approval; and (k) for IMerge Phase 3, the FDA may require Geron to submit additional information or require advisory committee procedures that could cause a regulatory approval, if any, to be delayed. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s quarterly report on Form 10-Q for the quarter ended March 31, 2023 and future filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances. Non-GAAP Financial Measure To supplement our financial results and guidance presented in accordance with GAAP, the Company is presenting non-GAAP total expenses, which excludes stock-based compensation expense, amortization of debt discounts and issuance costs and depreciation and amortization, from GAAP total expenses. The Company believes this non-GAAP financial measure, when considered together with other financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Geron’s results from period to period and to projected forward-looking guidance, and to identify operating trends in Geron’s business. The exclusion of non-cash items, such as stock-based compensation expense, amortization of debt discounts and issuance costs and depreciation and amortization, does not directly or immediately relate to the operational performance for the periods presented. This non-GAAP financial measure is in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Geron encourages investors to carefully consider the Company’s results under GAAP, as well as the supplemental non-GAAP financial information, to more fully understand Geron’s business. Financial table follows. GERON CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS UNAUDITED Three Months Ended March 31, (In thousands, except share and per share data) 2023 2022 Revenues: Royalties $ 21 $ 123 Operating expenses: Research and development 27,219 22,099 General and administrative 12,894 6,699 Total operating expenses 40,113 28,798 Loss from operations (40,092 ) (28,675 ) Interest income 3,853 112 Interest expense (1,922 ) (1,479 ) Other income and (expense), net 39 (56 ) Net loss $ (38,122 ) $ (30,098 ) Basic and diluted net loss per share: Net loss per share $ (0.07 ) $ (0.09 ) Shares used in computing net loss per share 544,459,004 332,066,889 CONDENSED CONSOLIDATED BALANCE SHEETS March 31, December 31, (In thousands) 2023 2022 (Unaudited) (Note 1) Current assets: Cash, cash equivalents and restricted cash $ 113,142 $ 57,209 Current marketable securities 267,964 115,901 Other current assets 5,917 7,136 Total current assets 387,023 180,246 Noncurrent marketable securities 28,100 — Property and equipment, net 1,066 793 Deposits and other assets 8,688 9,536 $ 424,877 $ 190,575 Current liabilities $ 43,911 $ 76,694 Noncurrent liabilities 54,911 33,883 Stockholders’ equity 326,055 79,998 $ 424,877 $ 190,575 Note 1: Derived from audited financial statements included in the Company’s annual report on Form 10-K for the year ended December 31, 2022.
- 05/11/2023
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Innate Pharma Reports First Quarter 2023 Financial Results and Business Update
- MARSEILLE, France--(BUSINESS WIRE)--Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today reported its consolidated financial results for the quarter ending March 31, 2023. “Our strong cash position was further bolstered during the first quarter of 2023 as we signed a license agreement with Takeda for antibody drug conjugates (ADC) using a panel of selected Innate antibodies, with a primary focus in Celiac disease. This agreement demonstrates our ability to expand the application of Innate’s science beyond our oncology focus and leverage partnership to value our assets. We also continue to see good progress for our ANKET® assets with our partner Sanofi presenting preclinical data at key medical congresses supporting the development of ongoing product candidates,” said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. “We remain committed to using our scientific expertise and strong partnerships to deliver innovative treatments for patients with cancer. We are looking forward to seeing Sanofi’s oral presentation with IPH6101/SAR’579 at the ASCO 2023 annual meeting along with two AstraZeneca Trial in progress posters for monalizumab. We progress towards important inflections points as we hit key milestones in H2 2023, including final readouts from the TELLOMAK Phase 2 trial with our lead proprietary program lacutamab and further updates for our ANKET® assets.” Webcast and conference call will be held today at 2:00pm CEST (8:00am EDT) The live webcast will be available at the following link: https://events.q4inc.com/attendee/824692547 Participants may also join via telephone using the following registration link: https://registrations.events/direct/Q4E61301 This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event. 1 Including short term investments (€17.1 million) and non-current financial instruments (€35.6 million). Pipeline highlights: Lacutamab (IPH4102, anti-KIR3DL2 antibody): Final MF and SS data expected in H2 2023. Innate continues to see progress for lacutamab with final data from the TELLOMAK Phase 2 trial for both mycosis fungoides (MF) and Sézary syndrome (SS) expected in H2 2023. Initial PTCL data are expected in H2 2023. Two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL) are ongoing. ANKET® (Antibody-based NK cell Engager Therapeutics): ANKET® is Innate’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer. Innate’s pipeline includes four public drug candidates born from the ANKET® platform: IPH6101 (CD123-targeted), IPH6401 (BCMA-targeted), IPH62 (B7-H3-targeted) and tetra-specific IPH6501 (CD20-targeted). Several other undisclosed proprietary preclinical targets are being explored. IPH6101, IPH6401 and IPH62 (partnered with Sanofi) The Phase 1/2 clinical trial by Sanofi is progressing well, evaluating IPH6101/SAR’579, the first NKp46/CD16-based CD123-targeted ANKET® platform NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia or high-risk myelodysplastic syndrome. Preclinical data showing the control of AML cells by a trifunctional NKp46-CD16a-NK cell engager targeting CD123 were published in Nature Biotechnology in January 2023. An abstract entitled “A first-in-human study of CD123 NK cell engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia, or high-risk myelodysplasia” has been selected for oral presentation at the American Society for Clinical Oncology (ASCO) 2023 Annual Meeting, taking place June 2-6, 2023 in Chicago, IL. Preclinical data showing the control of AML cells by a trifunctional NKp46-CD16a-NK cell engager targeting CD123 were published in Nature Biotechnology in January 2023. An abstract entitled “A first-in-human study of CD123 NK cell engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia, or high-risk myelodysplasia” has been selected for oral presentation at the American Society for Clinical Oncology (ASCO) 2023 Annual Meeting, taking place June 2-6, 2023 in Chicago, IL. Partner Sanofi continues to progress IPH6401/SAR’514, a BCMA-targeting NK cell engager into investigational new drug (IND)-enabling studies. Sanofi presented preclinical data showing IPH6401/SAR’514 has potent in-vitro, in-vivo and ex-vivo anti-myeloma effect through dual NK cell engagement in a poster at the American Association for Cancer Research (AACR) 2023 in April. Sanofi presented preclinical data showing IPH6401/SAR’514 has potent in-vitro, in-vivo and ex-vivo anti-myeloma effect through dual NK cell engagement in a poster at the American Association for Cancer Research (AACR) 2023 in April. As announced on December 19, 2022, Sanofi also licensed IPH62, a NK cell engager program targeting B7-H3 from Innate’s ANKET® platform. Sanofi also have the option to add up to two additional ANKET® targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization. Under the terms of the agreement, Innate received a €25m upfront payment and is eligible for up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales. IPH6501 (proprietary) IPH6501 continues toward a Phase 1 clinical trial in 2023 for the proprietary CD20 targeted tetra-specific ANKET®. Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca: Innate continues to see progress for monalizumab in the early non-small cell lung cancer (NSCLC) setting, with the ongoing Phase 3 PACIFIC-9 study run by AstraZeneca. The study is evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III NSCLC who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT). Two monalizumab abstracts have been accepted for “Trial in progress” posters at the American Society for Clinical Oncology (ASCO) 2023 Annual Meeting, taking place June 2-6, 2023 in Chicago, IL: Phase 3 study of durvalumab combined with oleclumab or monalizumab in patients with unresectable stage III NSCLC (PACIFIC-9). NeoCOAST-2: A Phase 2 study of neoadjuvant durvalumab plus novel immunotherapies (IO) and chemotherapy (CT) or MEDI5752 (volrustomig) plus CT, followed by surgery and adjuvant durvalumab plus novel IO or volrustomig alone in patients with resectable non-small-cell lung cancer (NSCLC). Two monalizumab abstracts have been accepted for “Trial in progress” posters at the American Society for Clinical Oncology (ASCO) 2023 Annual Meeting, taking place June 2-6, 2023 in Chicago, IL: Phase 3 study of durvalumab combined with oleclumab or monalizumab in patients with unresectable stage III NSCLC (PACIFIC-9). NeoCOAST-2: A Phase 2 study of neoadjuvant durvalumab plus novel immunotherapies (IO) and chemotherapy (CT) or MEDI5752 (volrustomig) plus CT, followed by surgery and adjuvant durvalumab plus novel IO or volrustomig alone in patients with resectable non-small-cell lung cancer (NSCLC). Phase 3 study of durvalumab combined with oleclumab or monalizumab in patients with unresectable stage III NSCLC (PACIFIC-9). NeoCOAST-2: A Phase 2 study of neoadjuvant durvalumab plus novel immunotherapies (IO) and chemotherapy (CT) or MEDI5752 (volrustomig) plus CT, followed by surgery and adjuvant durvalumab plus novel IO or volrustomig alone in patients with resectable non-small-cell lung cancer (NSCLC). IPH5201 (anti-CD39), partnered with AstraZeneca: The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, has started and is awaiting first patient dosed. IPH5301 (anti-CD73): The investigator-sponsored CHANCES Phase 1 trial of IPH5301, in collaboration with Institut Paoli-Calmettes is ongoing. Preclinical assets: In April 2023, Innate announced that it has entered into an exclusive license agreement with Takeda under which Innate grants Takeda exclusive worldwide rights to research and develop antibody drug conjugates (ADC) using a panel of selected Innate antibodies against an undisclosed target, with a primary focus in Celiac disease. Under the terms of the license agreement, Innate is due to receive a $5m upfront payment and is eligible to receive up to $410m in future development, regulatory and commercial milestones if all milestones are achieved during the term of the agreement, plus royalties on potential net sales of any commercial product resulting from the license. Fueling its R&D engine, the Company continues to develop different approaches for the treatment of cancer utilizing its antibody engineering capabilities to deliver novel assets, with its innovative ANKET® platform and continuing to explore Antibody Drug Conjugates (ADC) formats. Corporate update As a post period event, on April 26, Innate announced the establishment of a new At-The-Market (ATM) program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million American Depositary Shares (“ADS”). Each ADS representing one ordinary share of Innate. Financial Results: Cash, cash equivalents and financial assets of the Company amounted to €135.0 million as of March 31, 2023. At the same date, financial liabilities amounted to €41.1 million. Cash, cash equivalents and financial assets as of March 31, 2023 do not include the $5.0 million payment to be received from Takeda. Revenues for the first three months of 2023 amounted to €26.0 million (€2.6 million for the same period in 2022). For the three-month period, ended March 31, 2023, revenue from collaboration and licensing agreements mainly results from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca, Sanofi and Takeda. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform. Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET® multi-specific NK cell engagers to address multiple tumor types. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com and follow us on Twitter and LinkedIn. Information about Innate Pharma shares ISIN code FR0010331421 Ticker code Euronext: IPH Nasdaq: IPHA LEI 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2022, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.
- 05/10/2023
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MorphoSys AG Reports First Quarter 2023 Financial Results
- PLANEGG/MUNICH, Germany--(BUSINESS WIRE)--MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the first quarter of 2023. “We 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,” said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. “We 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.” Monjuvi/Minjuvi® Highlights: Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 20.8 million (€ 19.4 million) for the first quarter 2023 (Q1 2022: US$ 18.7 million (€ 16.6 million)). Minjuvi royalty revenue of € 0.7 million for sales outside of the U.S. in the first quarter 2023 (Q1 2022: € 0.7 million). Corporate Developments: On 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’s 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. On 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. Charlotte Lohmann was appointed as Chief Legal Officer on March 1, 2023 and will serve as a member of MorphoSys’ Management Board ad interim. On March 30, 2023, MorphoSys settled the repurchase of bonds in the value of € 62.9 million (approximately 19 % of the outstanding principal amount) resulting in an outstanding aggregate principal amount of the convertible bonds of € 262.1 million. Significant Events After the End of the First Quarter of 2023: Pelabresib: 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-naïve). More than 400 patients were enrolled in this study. The topline data are now expected by the end of 2023, earlier than previously anticipated. Tafasitamab: On April 4, 2023, MorphoSys announced that enrollment of the Phase 3 frontMIND study is also complete, with more than 880 patients enrolled in the trial. frontMIND 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. Conference Data Highlight: 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. New 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. Financial Results for the First Quarter of 2023 (IFRS): Total revenues for the first quarter 2023 were € 62.3 million compared to € 41.5 million for the same period in 2022. This increase resulted mainly from higher revenues from the sale of clinical vials. in € million* Q1 2023 Q4 2022 Q1 2022 Q-Q Δ Y-Y Δ Total revenues 62.3 81.6 41.5 (24) % 50 % Monjuvi product sales 19.4 24.7 16.6 (21) % 17 % Royalties 21.6 29.1 19.0 (26) % 14 % Licenses, milestones and other 21.3 27.9 5.8 (24) % > 100% * Differences due to rounding. Cost of Sales: Cost of sales in the first quarter of 2023 amounted to € 21.0 million (Q1 2022: € 7.9 million). The year-on-year increase resulted primarily from expenses related to vial sales to Incyte. Cost of sales related to Monjuvi U.S. product sales amounted to € 3.1 million in the first quarter of 2023. The gross margin of Monjuvi U.S. net product sales amounted to 84% (Q1 2022: 79%). Research and Development (R&D) Expenses: In the first quarter 2023, R&D expenses were € 83.1 million (Q1 2022: € 65.0 million). The increase mainly resulted from additional costs incurred due to the positive development of the patient recruitment in the major ongoing clinical studies of MorphoSys. Additionally, the first quarter of 2023 included a one-time effect resulting from severances in connection with the restructuring of the research area. Selling, General and Administrative (SG&A) Expenses: Selling expenses in the first quarter 2023 were € 16.9 million (Q1 2022: € 21.9 million). The decrease was driven by streamlining and focusing of selling efforts. General and administrative (G&A) expenses amounted to € 10.9 million (Q1 2022: € 14.6 million). Operating Loss: Operating loss amounted to € 69.5 million in the first quarter 2023 (Q1 2022: operating loss of € 68.0 million). Consolidated Net Loss: For the first quarter 2023, consolidated net loss was € 44.4 million (Q1 2022: consolidated net loss of € 122.7 million). Full Year 2023 Financial Guidance: Amounts in million 2023 Financial Guidance 2023 Guidance Insights Monjuvi U.S. net product sales US$ 80m to 95m 100% of Monjuvi U.S. net product sales are recorded on MorphoSys’ income statement and related profit/loss is split 50/50 between MorphoSys and Incyte. Gross margin for Monjuvi U.S. net product sales 75% to 80% 100% of Monjuvi U.S. product cost of sales are recorded on MorphoSys’ income statement and related profit/loss is split 50/50 between MorphoSys and Incyte. R&D expenses € 290m to 315m 2023 anticipated to be incrementally higher than 2022 due to the expansion of the pelabresib development program. SG&A expenses € 140m to 155m 45% to 50% of mid-point of SG&A expenses represent Monjuvi U.S. selling costs of which 100% are recorded in MorphoSys’ income statement. Incyte reimburses MorphoSys for half of these selling expenses. Additional information related to 2023 Financial Guidance: Tremfya® royalties will continue to be recorded as revenue without any cost of sales in MorphoSys’ income statement. These royalties, however, will not contribute any cash to MorphoSys, as 100% of the royalties will be passed on to Royalty Pharma. MorphoSys anticipates receiving royalties for Minjuvi sales outside of the U.S. MorphoSys does not anticipate any significant cash-accretive revenues from the achievement of milestones in 2023. MorphoSys anticipates sales of commercial and clinical supply of tafasitamab outside of the U.S. to its partner Incyte. Revenue from this supply is recorded in the “Licenses, milestones and other” category in MorphoSys’ income statement. These sales result in a zero gross profit/margin. MorphoSys does not provide guidance for these sales. Operational Outlook: The following events and development activities planned for 2023 and beyond include the following: topline results for the pivotal Phase 3 study (MANIFEST-2) of pelabresib in myelofibrosis (MF) by the end of 2023; primary analysis data from the Phase 3 study (inMIND) of tafasitamab in patients with indolent lymphoma (r/r FL/MZL) in 2024; primary analysis data from the pivotal Phase 3 study (frontMIND) of tafasitamab in previously untreated DLBCL in the second half of 2025. MorphoSys Group Key Figures (IFRS, end of the first quarter: March 31, 2023) in € million Q1 2023 Q1 2022 Δ Revenues 62.3 41.5 50 % Product Sales 19.4 16.6 17 % Royalties 21.6 19.0 14 % Licenses, Milestones and Other 21.3 5.8 >100% Cost of Sales (21.0) (7.9) >100% Gross Profit 41.3 33.6 23 % Total Operating Expenses (110.8) (101.5) 9 % Research and Development (83.1) (65.0) 28 % Selling (16.9) (21.9) (23) % General and Administrative (10.9) (14.6) (25) % Operating Profit / (Loss) (69.5) (68.0) 2 % Other Income 2.1 1.4 50 % Other Expenses (1.8) (3.7) (51) % Finance Income 55.0 10.6 >100% Finance Expenses (28.3) (62.8) (55) % Income from Reversals of Impairment Losses / (Impairment Losses) on Financial Assets 0.5 (0.1) >(100)% Share of Loss of Associates accounted for using the Equity Method (2.5) — n/a Income Tax Benefit / (Expenses) 0.0 0.0 n/a Consolidated Net Profit / (Loss) (44.4) (122.7) (64) % Earnings per Share, Basic and Diluted (in €) (1.30) (3.59) (64) % Cash and other financial assets (end of period) 791.5 907.2 * (13) % * Value as of December 31, 2022 MorphoSys will hold its conference call and webcast tomorrow, May 04, 2023, at 2:00pm CEST (1:00pm GMT/8:00am EST) to present the results for the first quarter 2023. Participants for the conference call and webcast may pre-register and will receive dedicated dial-in details to easily and quickly access the call: https://services.choruscall.it/DiamondPassRegistration/register?confirmationNumber=5835037&linkSecurityString=77dbe4aa2 Please dial in 10 minutes before the beginning of the conference. A live webcast and slides will be made available at the Investors section under "Events & Conferences" on MorphoSys' website, https://www.morphosys.com and after the call, a slide-synchronized audio replay of the conference will be available at the same location. The statement for the first quarter 2023 (IFRS) is available for download at: https://www.morphosys.com/en/investors/financial-information About MorphoSys At MorphoSys, we are driven by our mission: More life for people with cancer. As a global commercial-stage biopharmaceutical company, we develop and deliver innovative medicines, aspiring to redefine how cancer is treated. MorphoSys is headquartered in Planegg, Germany, and has its U.S. operations anchored in Boston, Massachusetts. To learn more, visit us at www.morphosys.com and follow us on Twitter and LinkedIn. About Monjuvi (tafasitamab-cxix) Monjuvi® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). In the United States, Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In Europe, Minjuvi® (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Monjuvi® and Minjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi® in the U.S., and marketed by Incyte under the brand name Minjuvi® in Europe, the UK and Canada. Tremfya® is a registered trademark of Janssen Biotech, Inc. XmAb® is a registered trademark of Xencor, Inc. Forward Looking Statements This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that MorphoSys' expectations may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
- 05/03/2023
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Membrane Microfiltration Global Market Report 2023: Increased Environmental Concern and Strict Legislation on Wastewater Treatment Fuels Growth - ResearchAndMarkets.com
- DUBLIN--(BUSINESS WIRE)--The "The Global Market for Membrane Microfiltration" report has been added to ResearchAndMarkets.com's offering. This report covers the technological, economic and business considerations of the microfiltration membrane market, with analyses and forecasts provided for global markets. Included in the report are descriptions of market forces relevant to the ultrafiltration membrane market and their areas of application. Microfiltration is a type of membrane filtration wherein forces such as pressure or concentration gradients proceed through a semipermeable membrane to isolation. Microfiltration membranes require less energy consumption for semi-dead-end set-up, compared to nano-filtration or reverse osmosis. Also, the pressure required in microfiltration membranes is much lesser than other membranes due to larger pore sizes. The demand of microfiltration membranes is high in industrial water treatment because it does not require energy-consuming phase transfer such as the evaporation technique. Different types of modules can be used for microfiltration processes depending on the shape and material of the membrane. Commercial designs that are available for microfiltration modules differ depending on the hydrodynamic and economic constraints and the mechanical stability of the device under operating pressure. The microfiltration modules used in the industry are: Tubular modules. Hollow fiber. Spiral-wound modules. Flat sheet. These membranes are widely used in a range of industries including water treatment, food and beverage processing, pharmaceutical manufacturing, and biotechnology. One of the most common applications of microfiltration membranes is in water treatment. In this process, the membranes are used to remove suspended solids, bacteria, and other contaminants from water. Microfiltration membranes are particularly useful in the treatment of surface waters and wastewaters, as they can remove a wide range of contaminants without the use of chemicals. In food and beverage processing, microfiltration membranes are used to remove bacteria, yeast, and other microorganisms from liquids such as milk, beer, and wine. This process is important for ensuring the safety and quality of these products, as well as for extending their shelf life. In the pharmaceutical industry, microfiltration membranes are used to purify drugs and other pharmaceutical products. The membranes can remove bacteria, viruses, and other contaminants from the products, ensuring their safety and efficacy. In biotechnology, microfiltration membranes are used for cell separation and clarification. The membranes can remove cells and other particles from culture fluids, allowing for the production of pure cell cultures and other biotechnology products. Overall, the use of microfiltration membranes has many advantages over other filtration technologies. These membranes operate at low pressures, which results in low energy consumption and operational costs. They are also highly effective in removing particles and microorganisms from fluids and do not require chemical agents or extensive pre-treatment of the fluid being filtered. Report Includes An overview of the global market for membrane microfiltration Estimation of the market size and analyses of market trends, with data from 2021, 2022, and projections of compound annual growth rates (CAGRs) through 2027 Explanation of market drivers, restraints and other forces impacting the global market Detailed description of filtration mechanism, filtration categories, microfiltration history, and other process Information on MF membrane products by the major applications of the technology: food and beverage processing, biopharmaceuticals manufacture, potable water production, wastewater treatment, industrial processes, and semiconductor fabrication Discussion of pricing considerations, R&D, government regulations and competitive technologies Coverage of events like mergers & acquisitions, joint ventures, collaborations or partnerships, and other key market strategies and a relevant patent analysis Company profiles of major players within the industry, including 3M, Merck KGgA, Mitsubishi Chemical Corp., and Toray Industries Inc. Key Topics Covered: Chapter 1 Introduction 1.1 Study Goals and Objectives 1.2 Reasons for Doing this Study 1.3 What's New in this Update? 1.4 Scope of Report 1.5 Methodology 1.6 Geographic Breakdown 1.7 Analyst's Credentials 1.8 Custom Research 1.9 Related Research Reports Chapter 2 Summary and Highlights Chapter 3 Market Overview 3.1 Description 3.2 Brief History of Microfiltration 3.3 Manufacturing Methods 3.3.1 Phase Separation 3.3.2 Track Etching 3.3.3 Stretching 3.3.4 Sintering 3.3.5 Semiconductor Production Techniques 3.4 Structure 3.5 Fouling 3.6 Pricing Chapter 4 Market Dynamics 4.1 Drivers 4.1.1 Growing Use of Microfiltration in Food & Beverage Industry 4.1.2 Increased Environmental Concern and Strict Legislation on Wastewater Treatment 4.1.3 Surge in the Demand for Microfiltration Membrane in Making Covid Vaccine 4.2 Challenges 4.2.1 High Maintenance 4.2.2 High Competition 4.3 Opportunities 4.3.1 Rise in Demand for Non-Chemical Water Treatment Techniques 4.3.2 Growth in Developing Nations 4.3.3 Advanced Water Treatment Technologies to Boost the Market 4.4 Restraints 4.4.1 Sensitivity to Oxidative Chemicals Chapter 5 Covid-19 Analysis 5.1 Impact on Demand 5.2 Impact on Supply 5.3 Impact on Price Chapter 6 Microfiltration Membranes Market by Material Type 6.1 Introduction 6.2 Ceramic 6.3 Polymeric 6.3.1 Polyvinylidene Fluoride 6.3.2 Cellulosics 6.3.3 Polypropylene 6.3.4 Polysulfones 6.3.5 Ptfe 6.3.6 Polyamides Chapter 7 Microfiltration Membranes Market by Membrane Form 7.1 Introduction 7.2 Hollow Fiber 7.3 Flat Sheet 7.4 Spiral-Wound 7.5 Tubular Chapter 8 Microfiltration Membranes Market by Application 8.1 Introduction 8.2 Biotech/Bioprocessing/Pharmaceutical 8.2.1 Laboratory-Scale Separations 8.2.2 Bioprocessing 8.2.3 Compendial Water Treatment 8.2.4 Market for Mf Membranes in Biotech, Bioprocessing and Pharmaceuticals 8.3 Drinking Water 8.3.1 Drinking Water Standards 8.3.2 Types of Microfiltration Membranes Used for Potable Water Treatment 8.3.3 Pretreatment to Seawater Desalination 8.3.4 Market for Microfiltration Membranes in Potable (Drinking) Water Treatment 8.4 Industrial Process Water and Wastewater 8.4.1 Major User Industries 8.4.2 Industrial Wastewater/Process-Water Treatment Market 8.5 Municipal/Domestic Wastewater 8.5.1 Membrane Bioreactors 8.5.2 Wastewater Reclamation and Reuse 8.5.3 Market for Mf Membranes in Municipal/Domestic Wastewater Treatment 8.6 Semiconductor 8.6.1 Ultrapure Deionized Microelectronics-Grade Water 8.6.2 Chemical Filtration 8.6.3 Chemical Mechanical Planarization Slurry Treatment 8.6.4 Market for Mf Membranes in Semiconductor/Electronics Manufacturing 8.7 Food and Beverage Manufacturing 8.7.1 Dairy 8.7.2 Alcoholic Beverages 8.7.3 Non-Alcoholic Beverages 8.7.4 Others 8.7.5 Market for Microfiltration Membranes in Food and Beverage Processing Chapter 9 Microfiltration Membranes Market by Region 9.1 North America 9.1.1 United States 9.1.2 Canada 9.1.3 Mexico 9.2 Europe 9.2.1 United Kingdom 9.2.2 Germany 9.2.3 France 9.2.4 Rest of Europe 9.3 Asia-Pacific 9.3.1 China 9.3.2 India 9.3.3 Japan 9.3.4 Rest of Asia-Pacific 9.4 Rest of the World Chapter 10 Industry Structure 10.1 Staying Competitive 10.2 Market Share Chapter 11 Company Profiles Chapter 12 Appendix: Microfiltration Membranes Companies Mentioned 3M Alfa Laval Donaldson Company Inc. Evoqua Water Technologies LLC Koch Separation Solutions Mann+Hummel Merck Kgaa Mitsubishi Chemical Corp. Pall Corp. Pentair Sartorius AG Synder Filtration Inc. Toray Industries Inc. For more information about this report visit https://www.researchandmarkets.com/r/oykbmv About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
- 05/03/2023
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Incyte Reports 2023 First Quarter Financial Results and Provides Updates on Key Clinical Programs
- WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today reports 2023 first quarter financial results, and provides a status update on the Company’s clinical development portfolio. "Our first quarter results demonstrate continued year-over-year double-digit revenue growth driven by Jakafi, which grew across all indications, and Opzelura, which is on track to become one of the most successful dermatology launches in recent years. In addition, we further expanded our commercial portfolio with several regulatory approvals including Opzelura for vitiligo in Europe.” said Hervé Hoppenot, Chief Executive Officer, Incyte. "Furthermore, in Q1 we made a decision to focus our development efforts on eight programs that have high potential value for us and discontinued six other programs. This allows us to optimize our allocation of resources on programs that can have a high impact for patients and for Incyte." Key Product Sales Performance Jakafi: Net product revenues of $580 million: Net product revenues grew 7% compared with the first quarter of 2022, driven by strong underlying patient demand growth (+7% Y/Y) including an 8% growth in new patients. Total patients grew across myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD). Net product revenues were unfavorably impacted by: Higher gross-to-net deductions, compared to fourth quarter of 2022, as a result of the Medicare coverage gap and higher commercial patient deductibles at the beginning of the plan year, as well as an increase in 340B orders. Lower than normal levels of channel inventory at the end of Q1, representing an $11 million impact. Higher gross-to-net deductions, compared to fourth quarter of 2022, as a result of the Medicare coverage gap and higher commercial patient deductibles at the beginning of the plan year, as well as an increase in 340B orders. Lower than normal levels of channel inventory at the end of Q1, representing an $11 million impact. Opzelura: Net product revenues of $57 million: Net product revenues grew 343% compared with the first quarter of 2022, driven by growth in patient demand and expansion in payer coverage as the launch in atopic dermatitis (AD) and vitiligo continues. Compared to the fourth quarter of 2022, net product revenues were unfavorably impacted by: Increase in co-pay assistance due to higher commercial patient deductibles at the beginning of the plan year, consistent with first quarter dynamics and higher Medicaid utilization volume. Acceleration of refills in December 2022 driven by patient demand in advance of annual deductible reset or health plan changes that negatively impacted refills during the months of January and February this year. Increase in co-pay assistance due to higher commercial patient deductibles at the beginning of the plan year, consistent with first quarter dynamics and higher Medicaid utilization volume. Acceleration of refills in December 2022 driven by patient demand in advance of annual deductible reset or health plan changes that negatively impacted refills during the months of January and February this year. Pipeline Updates MPNs and GVHD – key highlights LIMBER (Leadership In MPNs and GVHD BEyond Ruxolitinib): Our LIMBER development program encompasses multiple monotherapy and combination strategies, with the goal of improving upon the standard of care in MF, PV, GVHD and now, essential thrombocythemia (ET). Combination trials of ruxolitinib BID with zilurgisertib (ALK2) and INCB57643 (BET) are ongoing and progressing well. In early development, INCA33989 (mCALR) is on track for initiating first-in-human study in MF and ET in 2023. Additionally, a Phase 1 study evaluating ruxolitinib BID in combination with Cellenkos' CK0804 in MF is continuing to recruit patients. AGAVE-201, a global pivotal Phase 2 trial of axatilimab in patients with cGVHD is ongoing and results are on track for mid-2023. A Phase 1/2 combination trial of axatilimab in combination with ruxolitinib is being planned. The Phase 3 LIMBER-304 trial, evaluating parsaclisib in combination with ruxolitinib BID in suboptimal responders in MF and the Phase 3 LIMBER-313 trial, evaluating parsaclisib in combination with ruxolitinib BID in first-line MF, were discontinued following results of interim analyses that indicated that the studies were unlikely to meet their primary endpoints in the intent-to-treat patient population. The studies were not stopped due to safety. The U.S. Food and Drug Administration (FDA) issued a complete response letter for ruxolitinib extended-release (XR) tablets for once-daily (QD) use in the treatment of certain types of MF, PV and GVHD. Incyte will work with the FDA to determine appropriate next steps. Indication and status Ruxolitinib XR (QD) (JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD Ruxolitinib + zilurgisertib (JAK1/JAK2 + ALK2) Myelofibrosis: Phase 2 Ruxolitinib + INCB57643 (JAK1/JAK2 + BET) Myelofibrosis: Phase 2 Ruxolitinib + CK08041 (JAK1/JAK2 + CB-Tregs) Myelofibrosis: Phase 1 (LIMBER-TREG108) Axatilimab (anti-CSF-1R)2 Chronic GVHD: Pivotal Phase 2 (third-line plus therapy) (AGAVE-201) Ruxolitinib + axatilimab2 (JAK1/JAK2 + anti-CSF-1R) Chronic GVHD: Phase 1/2 in preparation INCA33989 (mCALR) Myelofibrosis, essential thrombocythemia: Entering clinic in 2023 1 Development collaboration with Cellenkos, Inc. 2 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals. Other Hematology/Oncology – key highlights Zynyz™ (retifanlimab-dlwr) approved for Merkel cell carcinoma in the U.S.: Zynyz, a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), received accelerated approval for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S. This represents the first regulatory approval for Incyte's PD-1 inhibitor, which is also being evaluated in pivotal trials in non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the anal canal (SCAC). Monjuvi® (tafasitamab-cxix)/Minjuvi® (tafasitamab): Minjuvi continues to launch in new ex-US markets, having gained reimbursement in two additional countries this quarter, bringing the total of launch markets to six. At the American Association for Cancer Research (AACR), final five-year follow-up data from the Phase 2 L-MIND study were presented, which showed that Monjuvi plus lenalidomide followed by Monjuvi monotherapy provided prolonged, durable responses in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Pemazyre® (pemigatinib) continues to expand in ex-U.S. markets in cholangiocarcinoma and myeloproliferative neoplasms (MLNs): Pemazyre was approved in Japan by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of MLNs with FGFR1 fusion. MLNs are a rare, aggressive group of cancers characterized by an over-production of myeloid cells, or bone tissue, with the tendency to rapidly progress to an acute myeloid leukemia (AML). The launch of Pemazyre in cholangiocarcinoma (CCA) is ongoing in 10 key markets in Europe. In clinical development, FIGHT-210, evaluating pemigatinib in NSCLC, was discontinued. Parsaclisib in warm autoimmune hemolytic anemia (wAIHA): Based on the challenging regulatory landscape associated with the PI3K class, development of parsaclisib in wAIHA has been discontinued. Indication and status Pemigatinib (Pemazyre®) (FGFR1/2/3) Myeloid/lymphoid neoplasms (MLN): approved in the U.S. and Japan Cholangiocarcinoma (CCA): Phase 3 (FIGHT-302) Glioblastoma: Phase 2 (FIGHT-209) Tafasitamab (Monjuvi®/Minjuvi®)1 (CD19) Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND) First-line DLBCL: Phase 3 (frontMIND) Relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL): Phase 3 (inMIND) Retifanlimab (Zynyz™)2 (PD-1) Merkel cell carcinoma: approved in the U.S. Squamous cell anal cancer (SCAC): Phase 3 (POD1UM-303) Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304) MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204) INCB99280 (Oral PD-L1) Solid tumors: Phase 1 KRASG12C-mutated solid tumors: Phase 1/1b in combination with adagrasib3, in preparation INCB99318 (Oral PD-L1) Solid tumors: Phase 1 1 Development of tafasitamab in collaboration with MorphoSys. 2 Retifanlimab licensed from MacroGenics. 3 Clinical trial collaboration and supply agreement with Mirati Therapeutics. Inflammation and Autoimmunity (IAI) – key highlights Dermatology Opzelura Opzelura approved for vitiligo in Europe: Opzelura was approved by the European Commission for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents 12 years of age and older. The EC decision is based on data from two pivotal Phase 3 clinical trials (TRuE-V1 and -V2), which showed treatment with Opzelura resulted in significant improvements in facial and total body repigmentation versus vehicle at Week 24 and among completers of an open-label extension at Week 52. Opzelura was well-tolerated with no serious treatment-related adverse events related to ruxolitinib cream. Opzelura 104-week safety and efficacy data in vitiligo provide insights into the value of long-term treatment: 104-week results from the long-term extension of the Phase 3 TRuE-V study were presented at the American Academy of Dermatology (AAD) Annual Meeting. The data demonstrated that many patients who achieved a high level of facial repigmentation (≥F-VASI90) at Week 52 were able to maintain durable response one year following withdrawal of treatment. In patients who did not achieve ≥F-VASI90 at Week 52 and continued treatment with Opzelura, improvements in facial and total body repigmentation, as shown by greater proportions of patients reaching F-VASI75 and T-VASI50, were observed through Week 104. Ruxolitinib cream in pediatric atopic dermatitis (AD): A Phase 3 trial of ruxolitinib cream in pediatric AD has completed enrollment with results expected by end of year. There are an estimated 2-3 million pediatric AD patients (ages 2-11) in the United States. Ruxolitinib cream in other indications: Incyte continues to expand the development of ruxolitinib cream into new indications as we seek to maximize the potential opportunity with the franchise. Phase 2 trials evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS), lichen planus (LP) and lichen sclerosus (LS) are ongoing. Additionally, two Phase 3 trials evaluating ruxolitinib cream in prurigo nodularis (PN) were initiated. Povorcitinib Phase 2 results in hidradenitis suppurativa: 52-week results from the Phase 2 study evaluating povorcitinib (15mg QD, 45mg QD, 75mg QD) in HS were presented as an oral presentation at the European Hidradenitis Suppurativa Foundation (EHSF) Annual Meeting. The data demonstrated that continuation of treatment with povorcitinib 75 mg resulted in sustained and durable efficacy across all treatment arms, and importantly, 22-29% of patients treated for 52-weeks achieved HiSCR100, which is defined as a 100% reduction from baseline in total abscess and nodule (AN) count with no increase from baseline in abscess or draining tunnel count. Povorcitinib is currently in two Phase 3 studies in moderate to severe HS. Phase 2 results in vitiligo: 36-week results from the Phase 2b study evaluating povorcitinib in patients with extensive vitiligo were presented as an oral late-breaking presentation at the American Academy of Dermatology (AAD) Annual Meeting. The data demonstrated that treatment with oral povorcitinib was associated with substantial total body repigmentation in patients with extensive nonsegmental vitiligo, as measured by total Vitiligo Area Scoring Index (T-VASI) scores. Specifically, the study met its primary endpoint, and patients receiving povorcitinib experienced statistically superior improvements in T-VASI at Week 24 compared to placebo (povorcitinib 15 mg, –19.1%; 45 mg, –17.8%; 75 mg, –15.7% vs. placebo, +2.3%; least squares mean [LSM] difference, P<0.01). Incyte plans to move into Phase 3 development for povorcitinib in vitiligo, pending FDA regulatory discussions. Studies planned for asthma and chronic spontaneous urticaria: Incyte announced the expansion of povorcitinib development into other inflammatory and autoimmune diseases, including planning for two Phase 2 trials in asthma and chronic spontaneous urticaria. Indication and status Ruxolitinib cream (Opzelura®)1 (JAK1/JAK2) AD: Phase 3 pediatric study (TRuE-AD3) Vitiligo: Phase 3 (TRuE-V1, TRuE-V2); approved in the U.S. and Europe Lichen planus: Phase 2 Lichen sclerosus: Phase 2 Hidradenitis suppurativa: Phase 2 Prurigo nodularis: Phase 3 initiated (TRuE-PN1, TRuE-PN2) Ruxolitinib cream + UVB (JAK1/JAK2 + phototherapy) Vitiligo: Phase 2 Povorcitinib (JAK1) Hidradenitis suppurativa: Phase 2b; Phase 3 (STOP-HS1, STOP-HS2) Vitiligo: Phase 2; Phase 3 planned Prurigo nodularis: Phase 2 Asthma: PoC planned Chronic spontaneous urticaria: PoC planned Auremolimab (anti-IL-15Rβ) Vitiligo: Phase 1 in preparation 1 Novartis’ rights to ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration. Discovery and other early development – key highlights INCB123667 (CDK2) oral presentation at the American Association for Cancer Research (AACR) 2023: INCB123667 is a selective and potent CDK2 kinase inhibitor, which has been shown to suppress tumor growth as monotherapy and in combination with standard of care, in Cyclin E amplified tumor models, in vivo. At AACR, Incyte presented data demonstrating INCB123667 exhibited significant single-agent activity in vivo in CCNE1high breast cancer xenograft and patient-derived xenograft models. INCB123667 is currently being evaluated in a Phase 1 clinical trial in patients with advanced malignancies including CCNE1high TNBC and HR+HER2- tumors post-CDK4/6 inhibitors. INCA33890 (TGFβR2xPD-1) in clinical development: INCA33890 is a TGFβR2xPD1 bispecific antibody which has been engineered to avoid the known toxicity of broad TGFβ pathway blockade. INCA33890 has higher affinity for PD1 than TGFβR2, and blocks TGFβ-signaling specifically in cells co-expressing PD-1, thus potentially sparing tissues where TGFb-signaling is important for normal function. Preclinical in vivo data presented at AACR show that INCA33890 has a greater anti-tumor effect than either individual benchmark antibodies or a simple combination of these. Development of the adenosine program (including INCB106385 and INCA00186), INCAGN1876 (GITR) and INCB81776 (AXL/MER) has been discontinued based on early efficacy data. Modality Candidates Small molecules INCB123667 (CDK2) Monoclonal antibodies INCAGN2385 (LAG-3)1, INCAGN2390 (TIM-3)1 Bi-specific antibodies INCA32459 (LAG-3xPD-1)2, INCA33890 (TGFβR2xPD-1)2 1 Discovery collaboration with Agenus. 2 Development in collaboration with Merus Partnered – key highlights Indication and status Ruxolitinib1 (JAK1/JAK2) Acute and chronic GVHD: approved in Europe; J-NDA under review Baricitinib2 (JAK1/JAK2) AD: approved in Europe and Japan Severe AA: approved in the U.S., Europe and Japan Capmatinib3 (MET) NSCLC (with MET exon 14 skipping mutations): approved in the U.S., Europe and Japan 1 Ruxolitinib (Jakavi®) licensed to Novartis ex-U.S. for use in hematology and oncology excluding topical administration. 2 Baricitinib (Olumiant®) licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis. 3 Capmatinib (Tabrecta®) licensed to Novartis. 2023 First Quarter Financial Results The financial measures presented in this press release for the three months ended March 31, 2023 and 2022 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry. As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP. Financial Highlights Financial Highlights (unaudited, in thousands, except per share amounts) Three Months Ended March 31, 2023 2022 Total GAAP revenues $ 808,673 $ 733,235 Total GAAP operating income 24,770 116,540 Total Non-GAAP operating income 89,729 172,147 GAAP net income 21,703 37,992 Non-GAAP net income 84,577 122,867 GAAP basic EPS $ 0.10 $ 0.17 Non-GAAP basic EPS $ 0.38 $ 0.56 GAAP diluted EPS $ 0.10 $ 0.17 Non-GAAP diluted EPS $ 0.37 $ 0.55 Revenue Details Revenue Details (unaudited, in thousands) Three Months Ended March 31, % Change (as reported) % Change (constant currency)1 2023 2022 Net product revenues: Jakafi $ 579,969 $ 544,464 7 % 7 % Iclusig 27,685 26,069 6 % 12 % Pemazyre 22,475 18,032 25 % 29 % Minjuvi 6,556 4,502 46 % 51 % Opzelura 56,552 12,754 343 % 343 % Total net product revenues 693,237 605,821 14 % 15 % Royalty revenues: Jakavi 76,692 70,867 8 % 16 % Olumiant 34,155 48,064 (29 %) (16 %) Tabrecta 4,177 3,483 20 % NA Pemazyre 412 — NM NM Total royalty revenues 115,436 122,414 (6 %) Total net product and royalty revenues 808,673 728,235 11 % Milestone and contract revenues — 5,000 (100 %) (100 %) Total GAAP revenues $ 808,673 $ 733,235 10 % NM = not meaningful NA = not available 1.Percentage change in constant currency is calculated using 2022 foreign exchange rates to recalculate 2023 results. Product and Royalty Revenues Product and royalty revenues for the three months ended March 31, 2023 increased 11% over the prior year comparative period as a result of net product revenues increasing 14% year-over-year, primarily driven by increases in Jakafi and Opzelura net product revenues. The increase in Jakafi net product revenues was primarily driven by growth in patient demand across all indications and was partially offset by higher gross-to-net deductions for Medicare and commercial co-pay assistance consistent with historical prior years' first quarters, as well as an increase in 340B volumes. The quarter was also impacted by lower weeks on hand channel inventory than normal due to timing of certain customer purchases. Opzelura net product revenues for the quarter were $57 million, representing a 343% increase year-over-year driven by increased patient demand and expanded coverage. The quarter was negatively impacted by an increase in co-pay assistance due to higher commercial patient deductibles at the beginning of the plan year and higher Medicaid utilization volume. In addition, volume was negatively impacted by an acceleration of refills in December 2022 driven by patient demand in advance of annual deductible reset or health plan changes. Jakavi and Olumiant royalties for the quarter were impacted by unfavorable changes in foreign currency exchange rates, while Olumiant royalties were also impacted by a decrease in net product sales of Olumiant for use as a treatment for COVID-19. Operating Expenses Operating Expense Summary (unaudited, in thousands) Three Months Ended March 31, % Change 2023 2022 GAAP cost of product revenues $ 56,822 $ 42,614 33 % Non-GAAP cost of product revenues1 50,669 36,619 38 % GAAP research and development 406,641 353,373 15 % Non-GAAP research and development2 375,620 327,045 15 % GAAP selling, general and administrative 315,606 209,584 51 % Non-GAAP selling, general and administrative3 294,017 192,682 53 % GAAP loss on change in fair value of acquisition-related contingent consideration 6,196 6,382 (3 %) Non-GAAP loss on change in fair value of acquisition-related contingent consideration4 — — — % GAAP (profit) and loss sharing under collaboration agreements (1,362 ) 4,742 (129 %) 1 Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation. 2 Non-GAAP research and development expenses exclude the cost of stock-based compensation. 3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation. 4 Non-GAAP loss on change in fair value of acquisition-related contingent consideration is null. Cost of product revenues GAAP and Non-GAAP cost of product revenues for three months ended March 31, 2023 increased 33% and 38%, respectively, compared to the same period in 2022 primarily due to product related costs for our commercial products including Opzelura. Research and development expenses GAAP and Non-GAAP research and development expense for three months ended March 31, 2023 increased 15%, compared to the same period in 2022 primarily due to continued investment in our late stage development assets and timing of certain expenses. Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the three months ended March 31, 2023 increased 51% and 53%, respectively, compared to the same period in 2022, primarily due to expenses related to promotional activities to support the launch of Opzelura for the treatments of atopic dermatitis and vitiligo and timing of certain expenses. Other Financial Information Operating income GAAP and Non-GAAP operating income for the three months ended March 31, 2023 decreased 79% and 48%, respectively, compared to the same period in 2022, primarily due to expenses related to promotional activities to support the launch of Opzelura for the treatments of atopic dermatitis and vitiligo and timing of certain expenses. Cash, cash equivalents and marketable securities position As of March 31, 2023 and December 31, 2022, cash, cash equivalents and marketable securities totaled $3.1 billion and $3.2 billion, respectively. The decrease from December 31, 2022 is due a reduction of our accounts payable balance at March 31, 2023. 2023 Financial Guidance Incyte is tightening its full year 2023 guidance for Jakafi net product revenues as a result of its strong first quarter performance. Guidance does not include revenue from any potential new product launches or the impact of any potential future strategic transactions. Incyte’s guidance is summarized below. Current Previous Jakafi net product revenues $2.55 - $2.63 billion $2.53 - $2.63 billion Other Hematology/Oncology net product revenues(1) $215 - $225 million Unchanged GAAP Cost of product revenues 7 – 8% of net product revenues Unchanged Non-GAAP Cost of product revenues(2) 6 – 7% of net product revenues Unchanged GAAP Research and development expenses $1,610 - $1,650 million Unchanged Non-GAAP Research and development expenses(3) $1,485 - $1,520 million Unchanged GAAP Selling, general and administrative expenses $1,050 - $1,150 million Unchanged Non-GAAP Selling, general and administrative expenses(3) $965 - $1,060 million Unchanged 1 Pemazyre in the U.S., EU and Japan and Iclusig and Minjuvi in the EU. 2 Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation. 3 Adjusted to exclude the estimated cost of stock-based compensation. Conference Call and Webcast Information Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13737924. If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13737924. The conference call will also be webcast live and can be accessed at investor.incyte.com. About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte. About Jakafi® (ruxolitinib) Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Jakafi is a registered trademark of Incyte. About Opzelura® (ruxolitinib) Cream 1.5% Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. Opzelura and the Opzelura logo are registered trademarks of Incyte. About Monjuvi®/Minjuvi® (tafasitamab) Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). In the United States, Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In Europe, Minjuvi® (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi® monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Minjuvi® and Monjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi® in the U.S., and marketed by Incyte under the brand name Minjuvi® in Europe and Canada. XmAb® is a registered trademark of Xencor, Inc. About Pemazyre® (pemigatinib) Pemazyre is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test*. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Pemazyre is marketed by Incyte in the United States, Europe and Japan. Pemazyre is a trademark of Incyte. * Pemazyre® (pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020. About Iclusig® (ponatinib) tablets Ponatinib (Iclusig®) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. About Zynyz™ (retifanlimab-dlwr) Zynyz (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. Zynyz is a trademark of Incyte. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this release contain predictions, estimates and other forward-looking statements, including any discussion of the following: Incyte’s potential for continued performance and growth; Incyte’s financial guidance for 2023, including its expectations regarding sales of Jakafi; expectations with respect to demand for and uptake of Opzelura; the potential for ruxolitinib cream to expand into other indications; expectations regarding the potential and progress of programs in our pipeline and the delivery of same; expectations regarding ongoing clinical trials and clinical trials to be initiated, including the LIMBER program, INCA33989 (mCALR) in MF and ET, a Phase 1 study evaluating ruxolitinib BID in combination with Cellenkos' CK0804 in MF, axatilimab in cGVHD (alone and in combination with ruxolitinib), Incyte’s oral PD-L1 program, a phase 3 trial of ruxolitinib cream in pediatric AD, phase 2 and 3 trials of povorcitinib in multiple indications and a phase 1 trial of auremolimab in vitiligo; our and our collaborators’ potential for receiving additional regulatory approvals within the next 1-2 years and the corresponding potential for launches of new products and/or indications; Incyte’s plan to work with the FDA to determine next steps for ruxolitinib extended-release (XR) tablets for once-daily (QD) use; expectations regarding ongoing launches by us and our collaborators; and our expectations regarding 2023 newsflow items. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID 19 pandemic and measures to address the pandemic on Incyte’s clinical trials, supply chain and other third-party providers, sales and marketing efforts and business, development and discovery operations; determinations made by the FDA, EMA, and other regulatory agencies; Incyte’s dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of Incyte’s products and the products of Incyte’s collaboration partners; the acceptance of Incyte’s products and the products of Incyte’s collaboration partners in the marketplace; market competition; unexpected variations in the demand for Incyte’s products and the products of Incyte’s collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte’s products and the products of Incyte’s collaboration partners; sales, marketing, manufacturing and distribution requirements, including Incyte’s and its collaboration partners’ ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; variations in foreign currency exchange rates; and other risks detailed in Incyte’s reports filed with the Securities and Exchange Commission, including its annual report for the year ended December 31, 2022. Incyte disclaims any intent or obligation to update these forward-looking statements. INCYTE CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited, in thousands, except per share amounts) Three Months Ended March 31, 2023 2022 GAAP Revenues: Product revenues, net $ 693,237 $ 605,821 Product royalty revenues 115,436 122,414 Milestone and contract revenues — 5,000 Total revenues 808,673 733,235 Costs and expenses: Cost of product revenues (including definite-lived intangible amortization) 56,822 42,614 Research and development 406,641 353,373 Selling, general and administrative 315,606 209,584 Loss on change in fair value of acquisition-related contingent consideration 6,196 6,382 (Profit) and loss sharing under collaboration agreements (1,362 ) 4,742 Total costs and expenses 783,903 616,695 Income from operations 24,770 116,540 Interest income and other, net 32,873 1,260 Interest expense (469 ) (680 ) Unrealized loss on long term investments (5,318 ) (46,585 ) Income before provision for income taxes 51,856 70,535 Provision for income taxes 30,153 32,543 Net income $ 21,703 $ 37,992 Net income per share: Basic $ 0.10 $ 0.17 Diluted $ 0.10 $ 0.17 Shares used in computing net income per share: Basic 222,960 221,326 Diluted 225,589 222,950 INCYTE CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands) March 31, 2023 December 31, 2022 ASSETS Cash, cash equivalents and marketable securities $ 3,112,712 $ 3,238,965 Accounts receivable 623,788 644,879 Property and equipment, net 741,701 739,310 Finance lease right-of-use assets, net 25,849 26,298 Inventory 157,564 120,959 Prepaid expenses and other assets 216,694 194,144 Long term investments 128,313 133,676 Other intangible assets, net 140,658 129,219 Goodwill 155,593 155,593 Deferred income tax asset 494,751 457,941 Total assets $ 5,797,623 $ 5,840,984 LIABILITIES AND STOCKHOLDERS’ EQUITY Accounts payable, accrued expenses and other liabilities $ 1,084,207 $ 1,216,603 Finance lease liabilities 32,848 33,262 Acquisition-related contingent consideration 218,000 221,000 Stockholders’ equity 4,462,568 4,370,119 Total liabilities and stockholders’ equity $ 5,797,623 $ 5,840,984 INCYTE CORPORATION RECONCILIATION OF GAAP NET (LOSS) INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION (unaudited, in thousands, except per share amounts) Three Months Ended March 31, 2023 2022 GAAP Net Income $ 21,703 $ 37,992 Adjustments1: Non-cash stock compensation from equity awards (R&D)2 31,021 26,328 Non-cash stock compensation from equity awards (SG&A)2 21,589 16,902 Non-cash stock compensation from equity awards (COGS)2 769 611 Non-cash interest3 108 108 Changes in fair value of equity investments4 5,318 46,585 Amortization of acquired product rights5 5,384 5,384 Loss on change in fair value of contingent consideration6 6,196 6,382 Tax effect of Non-GAAP pre-tax adjustments7 (7,511 ) (17,425 ) Non-GAAP Net Income $ 84,577 $ 122,867 Non-GAAP net income per share: Basic $ 0.38 $ 0.56 Diluted $ 0.37 $ 0.55 Shares used in computing Non-GAAP net income per share: Basic 222,960 221,326 Diluted 225,589 222,950 1 Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three months ended March 31, 2023 and 2022 are milestones of $0 and $5,000, respectively, earned from our collaborative partners. Included within the Research and development expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three months ended March 31, 2023 and 2022 are upfront consideration and milestones of $2,700 and $20,000, respectively, related to our collaborative partners. 2 As included within the Cost of product revenues (including definite-lived intangible amortization) line item; the Research and development expenses line item; and the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations. 3 As included within the Interest expense line item in the Condensed Consolidated Statements of Operations. 4 As included within the Unrealized loss on long term investments line item in the Condensed Consolidated Statements of Operations. 5 As included within the Cost of product revenues (including definite-lived intangible amortization) line item in the Condensed Consolidated Statements of Operations. Acquired product rights of licensed intellectual property for Iclusig is amortized utilizing a straight-line method over the estimated useful life of 12.5 years. 6 As included within the Loss on change in fair value of acquisition-related contingent consideration line item in the Condensed Consolidated Statements of Operations. 7 Income tax effects of Non-GAAP pre-tax adjustments are calculated using an estimated annual effective tax rate, taking into consideration any permanent items and valuation allowances against related deferred tax assets.
- 05/02/2023
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7 Low Float Penny Stocks To Watch After SNTG Stock Explodes
- More low float penny stocks to watch. The post 7 Low Float Penny Stocks To Watch After SNTG Stock Explodes appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
- 05/01/2023
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3 Low Float Penny Stocks To Watch Today
- Low float penny stocks to watch. The post 3 Low Float Penny Stocks To Watch Today appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
- 04/28/2023
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First Comprehensive Care Plan to Prevent Preeclampsia Published in the American Journal of Obstetrics and Gynecology
- SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--A new special report published in the American Journal of Obstetrics and Gynecology (AJOG) provides a groundbreaking approach to preeclampsia, one of the most pressing issues in maternal health today and will translate the prediction of risk into prevention of disease. The report, “Care plan for individuals at risk for preeclampsia: Shared approach to education, strategies for prevention, surveillance and follow up,” provides specific recommendations for both expecting parents and clinicians. The Care Plan’s recommendations include consideration of daily low-dose aspirin, surveillance, behavioral strategies, patient and provider education, addressing social determinants of health, and long-term follow up. These recommendations are a significant shift from the current care approach, which has historically lacked a comprehensive, integrated strategy. While technology to reliably predict preeclampsia is imminent, until now there has not been clear direction on optimal strategies for its prevention. A leading cause of pregnancy-related deaths in the U.S.,1 preeclampsia is a disorder of high blood pressure that can result in preterm birth, organ damage, and other severe complications during pregnancy. The impact of preeclampsia can extend across a lifetime for both moms and babies. With maternal mortality rising in recent years2 and high blood pressure disorders in pregnancy (including preeclampsia) doubling since 20073, there is an urgent need to predict, prevent, and mitigate its devastating impact. Fortunately, there are several effective interventions that have been associated with reduced risk of preeclampsia in individuals at increased risk.4-6 The new AJOG report synthesizes them all into an objective, evidence-based recommendation for the first time and provides checklists for both individuals at risk and health care providers, which can be downloaded and shared. Today, most pregnant individuals at increased risk do not receive even one of the interventions to prevent preeclampsia. For example, less than half of high-risk patients receive low-dose aspirin.7 By streamlining the evidence-based recommendations into a straightforward Care Plan, the report systematically outlines the multi-pronged preventive approach that patients at risk should be receiving, which includes: Key recommendations for health care providers: Risk assessment including social determinants of health, pharmacological recommendations (including aspirin therapy and antihypertensive therapy), and behavioral recommendations (including specific information about diet, exercise, and sleep) Key recommendations for persons at-risk for preeclampsia: To discuss with a health care provider: Questions regarding aspirin use, exercise during pregnancy, blood pressure monitoring, and more To do on their own: Watching for signs of preeclampsia with symptoms listed, checking blood pressure at home and reporting any readings greater than 140/90, implementing dietary, exercise, and sleep changes, and more To discuss with a health care provider: Questions regarding aspirin use, exercise during pregnancy, blood pressure monitoring, and more To do on their own: Watching for signs of preeclampsia with symptoms listed, checking blood pressure at home and reporting any readings greater than 140/90, implementing dietary, exercise, and sleep changes, and more “This new comprehensive Care Plan, developed by a diverse group of preeclampsia experts, payers and advocates is a specific and clear set of recommendations based on peer-reviewed evidence and expert opinion,” said James Roberts, M.D., a Maternal-Fetal Medicine researcher at the Magee-Womens Research Institute, UPMC and founding Principal Investigator of the Global Pregnancy Collaboration who is one of the lead authors. “The plan outlines medications, monitoring, behavioral modification, education, and considerations for social determinants of health. It is designed to be as safe, cost-effective, and practical to implement in real world practice as possible. The clear checklists further encourage their use for any pregnancy considered to be at increased risk for developing preeclampsia,” added Dr. Roberts. He said the team intends to have these checklists translated into multiple languages to further improve access and use. ”Objective prediction of preeclampsia risk months in advance will soon be possible, and the Care Plan answers the question of what to do with that information,’” said Alison Cowan, M.D., M.S.C.R. and Head of Medical Affairs at Mirvie. “An unprecedented collaboration between medical experts and preeclampsia advocates created this novel patient-centered Care Plan. It represents a critical step in preventing preeclampsia and saving lives.” Mirvie, a company developing the first platform to predict pregnancy complications by revealing the underlying biology, supported the independent development of this report to contribute to an increased understanding of how to prevent preeclampsia. Eleni Tsigas, CEO of the Preeclampsia Foundation and one of the co-authors, noted, “By centering preeclampsia survivors as experts and co-authors, alongside clinicians, researchers, and payers, we have produced a practical and proactive comprehensive Care Plan. It is written in clear and simple language, can be easily incorporated into electronic health record (EHR) systems, and is designed to be a cooperative plan for both women and their care teams. With consistent implementation in any setting, we expect this Care Plan will help address inequalities in maternal care.” With objective, predictive testing for preeclampsia imminently on the horizon, this integrated Care Plan will translate risk prediction into disease prevention. As many women without traditional risk factors will still develop preeclampsia, this combination of novel predictive and preventive tools will prove to be indispensable for all clinicians and patients seeking to prevent this serious pregnancy complication and the lifelong health impacts of preeclampsia. About Mirvie Mirvie is shaping the future of pregnancy health by providing women, expecting parents and their doctors with an early detection window to intervene before unexpected pregnancy complications become a crisis. One in five pregnancies is impacted by complications that lead to lifelong health consequences for expecting parents and babies. The proprietary Mirvie RNA platform uses a simple blood test to reveal vital information about a pregnancy’s unique biology and detect complications months before they occur. The idea for Mirvie was sparked by the personal experience of one of the founders whose daughter was born prematurely. Mirvie’s team of world-class scientists and entrepreneurs have brought to market category-first, non-invasive tests in both women’s health and in early cancer detection, used by millions today. Founded in 2018, Mirvie has raised more than $90 million in early-stage financing from top-tier investors, including Decheng Capital, Foresite Capital, General Catalyst, GV, Khosla Ventures, and Mayfield. Mirvie is based in South San Francisco, California. To learn more about Mirvie, please visit www.mirvie.com. About Global Pregnancy Collaboration The Global Pregnancy Collaboration (CoLab) is an international consortium of 40 centers. CoLab promotes collaboration in pregnancy research to improve maternal and child health worldwide. This is accomplished by assisting collaboration and sharing of data and biological samples, and education with special attention to developing research infrastructure in low-resource settings. Efforts address the needs of all maternal child health care—from the simplest in the most resource-poor countries to the most sophisticated research in more privileged areas. For more information, visit https://pregnancycolab.tghn.org. About Preeclampsia Foundation The Preeclampsia Foundation is a U.S.-based 501(c)(3) non-profit organization established in 2000 to improve the outcomes of hypertensive disorders of pregnancy by educating, supporting, and engaging the community, improving healthcare practices, and finding a cure. We envision a world where preeclampsia and related hypertensive disorders of pregnancy no longer threaten the lives of mothers and babies. For more information, visit www.preeclampsia.org. References
- 04/28/2023
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Geron Announces Upcoming Oral Presentation at 2023 American Society of Clinical Oncology Annual Meeting of Imetelstat Data from IMerge Phase 3 Lower Risk MDS Trial
- FOSTER CITY, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that data from the pivotal IMerge Phase 3 clinical trial evaluating the Company’s first-in-class telomerase inhibitor, imetelstat, in lower risk myelodysplastic syndromes (MDS), was accepted for oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The data in the ASCO abstract will be embargoed per ASCO guidelines until May 25, 2023 at 5 p.m. Eastern Time. ASCO is taking place in Chicago, IL from June 2-6, 2023. Details for the oral presentation are as follows: Title: IMerge: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Imetelstat in Patients (pts) With Heavily Transfusion Dependent (TD) Non-Del(5q) Lower-Risk Myelodysplastic Syndromes (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESA). Presenter: Amer Methqal Zeidan, Yale School of Medicine Abstract number: 7004 Date: Friday, June 2, 2023 Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant About IMerge Phase 3 The Phase 3 portion of the IMerge Phase 2/3 study is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower risk) transfusion dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a HMA or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of RBC-TI lasting at least eight weeks, defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week TI), the duration of TI and the rate of hematologic improvement erythroid (HI-E), which is defined as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across North America, Europe, Middle East and Asia. About Imetelstat Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment. Geron plans to submit a New Drug Application (NDA) in the U.S. in mid-2023 and a Marketing Authorization Application (MAA) in the EU in the second half of 2023 in the lower risk MDS indication. About Geron Geron is a late-stage biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. Its investigational first-in-class telomerase inhibitor, imetelstat, harnesses Nobel Prize winning science in a treatment that may alter the underlying course of these diseases. To learn more, visit http://www.geron.com/or follow us on LinkedIn. Use of Forward-Looking Statements Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) that for imetelstat in lower risk MDS, Geron plans to submit an NDA in the U.S. in mid-2023 and an MAA in the EU in the second half of 2023; (ii) that imetelstat has potential disease modifying activity; and (iii) other statements that are not historical. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties include, without limitation, risks and uncertainties related to: (a) whether regulatory authorities accept for filing Geron’s NDA and MAA; (b) whether imetelstat actually demonstrates disease-modifying activity in patients in clinical trials; and (c) whether regulatory authorities continue to permit imetelstat to be administered to patients in clinical trials. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s Annual Report on Form 10-K filed on March 16, 2023, and future filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements.
- 04/26/2023
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Form 8.3 - John Wood Group PLC
- LONDON--(BUSINESS WIRE)-- FORM 8.3 PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE Rule 8.3 of the Takeover Code (the “Code”) 1. KEY INFORMATION (a) Full name of discloser: Computershare Trustees (Jersey) Limited as trustee of the John Wood Group plc Employee Share Trust (b) Owner or controller of interests and short positions disclosed, if different from 1(a): The naming of nominee or vehicle companies is insufficient. For a trust, the trustee(s), settlor and beneficiaries must be named. Settlor is John Wood Group plc Beneficiaries are defined in trust deed as “a bona fide Employee or former Employee or the wife, husband, widow, widower or children or step-children under the age of 18 of such Employee or former Employee excluding any person resident in the Island of Jersey for the purposes of Jersey law PROVIDED THAT, subject to Clause 20, any person who is an Excluded Person shall not be a Beneficiary)”. Employees are defined as “the employees (including executive directors) of the Group from time to time”. Group is defined as “the Company and any company which is for the time being and from time to time its subsidiary or a subsidiary of its holding company”. (c) Name of offeror/offeree in relation to whose relevant securities this form relates: Use a separate form for each offeror/offeree John Wood Group plc as Offeree (d) If an exempt fund manager connected with an offeror/offeree, state this and specify identity of offeror/offeree: (e) Date position held/dealing undertaken: For an opening position disclosure, state the latest practicable date prior to the disclosure 25 APRIL 2023 (f) In addition to the company in 1(c) above, is the discloser making disclosures in respect of any other party to the offer? If it is a cash offer or possible cash offer, state “N/A” N/A If YES, specify which: 2. POSITIONS OF THE PERSON MAKING THE DISCLOSURE If there are positions or rights to subscribe to disclose in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 2(a) or (b) (as appropriate) for each additional class of relevant security. (a) Interests and short positions in the relevant securities of the offeror or offeree to which the disclosure relates following the dealing (if any) Class of relevant security: Ordinary 4 2/7p shares in John Wood Group plc Interests Short positions Number % Number % (1) Relevant securities owned and/or controlled: 5,968,511 0.8627% (2) Cash-settled derivatives: (3) Stock-settled derivatives (including options) and agreements to purchase/sell: TOTAL: 5,968,511 0.8627% All interests and all short positions should be disclosed. Details of any open stock-settled derivative positions (including traded options), or agreements to purchase or sell relevant securities, should be given on a Supplemental Form 8 (Open Positions). (b) Rights to subscribe for new securities (including directors’ and other employee options) Class of relevant security in relation to which subscription right exists: Details, including nature of the rights concerned and relevant percentages: 3. DEALINGS (IF ANY) BY THE PERSON MAKING THE DISCLOSURE Where there have been dealings in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 3(a), (b), (c) or (d) (as appropriate) for each additional class of relevant security dealt in. The currency of all prices and other monetary amounts should be stated. (a) Purchases and sales Class of relevant security Purchase/sale Number of securities Price per unit (b) Cash-settled derivative transactions Class of relevant security Product description e.g. CFD Nature of dealing e.g. opening/closing a long/short position, increasing/reducing a long/short position Number of reference securities Price per unit (c) Stock-settled derivative transactions (including options) (i) Writing, selling, purchasing or varying Class of relevant security Product description e.g. call option Writing, purchasing, selling, varying etc. Number of securities to which option relates Exercise price per unit Type e.g. American, European etc. Expiry date Option money paid/ received per unit (ii) Exercise Class of relevant security Product description e.g. call option Exercising/ exercised against Number of securities Exercise price per unit (d) Other dealings (including subscribing for new securities) Class of relevant security Nature of dealing e.g. subscription, conversion Details Price per unit (if applicable) WOOD GROUP (JOHN) PLC ORD 4 2/7P Transfer of shares out to satisfy awards exercised (1,029,444) N/A 4. OTHER INFORMATION (a) Indemnity and other dealing arrangements Details of any indemnity or option arrangement, or any agreement or understanding, formal or informal, relating to relevant securities which may be an inducement to deal or refrain from dealing entered into by the person making the disclosure and any party to the offer or any person acting in concert with a party to the offer: Irrevocable commitments and letters of intent should not be included. If there are no such agreements, arrangements or understandings, state “none” None (b) Agreements, arrangements or understandings relating to options or derivatives Details of any agreement, arrangement or understanding, formal or informal, between the person making the disclosure and any other person relating to: (i) the voting rights of any relevant securities under any option; or (ii) the voting rights or future acquisition or disposal of any relevant securities to which any derivative is referenced: If there are no such agreements, arrangements or understandings, state “none” None (c) Attachments Is a Supplemental Form 8 (Open Positions) attached? NO Date of disclosure: 26 APRIL 2023 Contact name: Emma Berry Telephone number*: 01534 281881 Public disclosures under Rule 8 of the Code must be made to a Regulatory Information Service. The Panel’s Market Surveillance Unit is available for consultation in relation to the Code’s disclosure requirements on +44 (0)20 7638 0129. *If the discloser is a natural person, a telephone number does not need to be included, provided contact information has been provided to the Panel’s Market Surveillance Unit. The Code can be viewed on the Panel’s website at www.thetakeoverpanel.org.uk. MF 25/04/2023
- 04/26/2023
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The 7 Most Sold-Off Stocks of 2022
- With a contentious time in 2022 coming to a close, it may be helpful to look back and consider the most sold-off stocks last year. Similar to learning from prior mistakes, investors may be able to garner lessons from the worst-hit market ideas.
- 12/24/2022
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Missfresh (MF) Stock: ADS Ratio Change Goes Into Effect
- An ADS ratio change of Missfresh (MF) stock has gone into effect. These are the details.
- 10/17/2022
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Beijing consumer rights group summons grocery firm Missfresh over complaints
- A Beijing consumer rights group said on Tuesday it had asked Missfresh to work on plans to refund its customers and explain how it will rectify its business after receiving a number of complaints, adding to pressures facing the Tencent Holdings and Tiger Global-backed grocery startup.
- 08/09/2022
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Chinese Grocery Service Missfresh Faces Multiple Lawsuits
- Chinese grocery delivery company Missfresh is facing lawsuits from both laid-off employees and investors, alleging unpaid salaries and violations of securities laws. Missfresh, which was a pioneer in the country's fast grocery delivery space, sold itself by saying it could make 30-minute grocery delivery profitable, the Financial Times reported Tuesday (Aug. 2).
- 08/02/2022
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Hot Penny Stocks to Watch in the Second Half of July
- Are these penny stocks on your watchlist? The post Hot Penny Stocks to Watch in the Second Half of July appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
- 07/15/2022
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Best Penny Stocks to Buy That Exploded Today? 3 to Watch
- Check these penny stocks out for your watchlist right now The post Best Penny Stocks to Buy That Exploded Today? 3 to Watch appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
- 06/06/2022
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What to Know About Buying Penny Stocks on June 2nd
- Here's what you need to know about trading penny stocks on June 2nd The post What to Know About Buying Penny Stocks on June 2nd appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
- 06/02/2022
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Why Missfresh Limited Stock Jumped Today
- The Chinese penny stock jumped on a possible short squeeze.
- 04/06/2022
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Dingdong, Missfresh Surge On Booming Business During Covid Lockdowns
- Investors may be growing more bullish on Dingdong and Missfresh as recent Covid-related lockdowns drive more consumers to buy groceries online.
- 04/06/2022
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Missfresh Tries To Tempt Investors With Value-Added Offerings
- Key takeaways: • Missfresh has launched a series of value-added initiatives in its bid to achieve profitability by selling more higher-margin products outside its core online grocery business
- 01/28/2022
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3 Reasons This Chinese Grocery Company's Cutting-Edge Business Model Could Be a Winner
- Micro fulfillment centers and other advanced features are powering growth.
- 11/27/2021
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Missfresh's Focus On High-Value Customer Growth Will Pay Off
- MF's focus on high-value customers and high-quality growth will pay off in the long run. MF is traded at 0.63 P/S vs DDL 1.45 P/S - Investors might have overlooked MF's differentiated growth strategy.
- 11/15/2021
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Missfresh Limited's (MF) CEO Zheng Xu on Q3 2021 Results - Earnings Call Transcript
- Missfresh Limited's (MF) CEO Zheng Xu on Q3 2021 Results - Earnings Call Transcript
- 11/13/2021
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Missfresh Limited (MF) Stock: Why The Price Jumped Today
- The stock price of Missfresh Limited (NASDAQ: MF) increased by over 10% pre-market today. This is why it happened.
- 11/12/2021
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Missfresh Limited to Report Third Quarter 2021 Financial Results on Thursday, November 11, 2021
- - Earnings Call Scheduled for 8:00 p.m. ET on November 11, 2021 -
- 11/08/2021
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Missfresh: An Innovation-Driven Online Retailer
- Chinese neighborhood retail is a massive market with plenty of opportunities for digitalization.
- 10/12/2021
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Missfresh Expands On-demand Live Seafood Delivery Business to 8 Cities in China
- BEIJING, Sept. 16, 2021 /PRNewswire/ -- Missfresh Limited ("Missfresh" or the "Company") (NASDAQ: MF), an innovator and leader in China's neighborhood retail industry, is accelerating the rollout of its instant live seafood delivery (as quick as 30 minutes) to customers across China, having seen 20X growth in live seafood delivery sales since March.
- 09/16/2021
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Missfresh Limited to Participate in the Upcoming Investor Conferences
- BEIJING, Aug. 30, 2021 (GLOBE NEWSWIRE) -- Missfresh Limited (“Missfresh” or the “Company”) (NASDAQ: MF), an innovator and leader in China's neighborhood retail industry, today announced its participation in the following investor conferences:
- 08/30/2021
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Can Missfresh Replicate The Success Of Amazon Fresh?
- Missfresh has a decent 4000+ Grocery selection covering Fresh Produce, Meat & Seafood, Dairy & Eggs, Frozen Foods, Beer, Wine & Spirits, and Household. The Retail Neighborhood market is $2.5 trillion, expecting continued digitization.
- 08/30/2021
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Missfresh Limited (MF) CEO Zheng Xu on Q2 2021 Results - Earnings Call Transcript
- Missfresh Limited (MF) CEO Zheng Xu on Q2 2021 Results - Earnings Call Transcript
- 08/27/2021
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Missfresh Limited Reports Second Quarter 2021 Unaudited Financial Results
- BEIJING, Aug. 26, 2021 (GLOBE NEWSWIRE) -- Missfresh Limited (“Missfresh” or the “Company”) (NASDAQ: MF), an innovator and leader in China's neighborhood retail industry, today announced its unaudited financial results for the second quarter ended June 30, 2021.
- 08/26/2021
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Missfresh Reports Solid Sales On JD.com Platforms
- Missfresh Ltd (NASDAQ: MF) clocked a 389% increase in sales on JD.Com Inc's (NASDAQ: JD) JD.com and JD-Daojia (JDDJ) since the start of its collaboration in April 2021. Currently, ~570 of Missfresh's Distributed Mini Warehouses (DMWs) sell on JDDJ in 17 cities across China.
- 08/25/2021
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Missfresh Deploys Smart Vending Machines in Partnership With Over 5,000 Businesses
- BEIJING, Aug. 23, 2021 /PRNewswire/ -- Self-service vending machines have long been a fixture in daily life, but the products they carry are increasingly diverse. As part of Missfresh Limited 's ("Missfresh" or the "Company") (NASDAQ: MF) efforts to drive the digitalization and modernization of the neighborhood retail industry and offer consumers an even more convenient shopping experience, the company recently partnered with more than 5,000 businesses in Beijing to deploy Missfresh Convenience Go Smart Vending Machines on their premises.
- 08/23/2021
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Missfresh Limited to Report Second Quarter 2021 Financial Results on Thursday, August 26, 2021
- - Earnings Call Scheduled for 9:00 p.m. ET on August 26, 2021 - - Earnings Call Scheduled for 9:00 p.m. ET on August 26, 2021 -
- 08/23/2021
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Mondelez (MDLZ) Teams Up With MissFresh, Fuels China Expansion
- Mondelez (MDLZ) teams up with MissFresh to offer Oreo Zero on the latter's popular online retail platform. This will give online customers of China access to OREO's new sugar-free sandwiches.
- 08/20/2021
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Missfresh Partners With Mondelez to Deliver Sugar-Free Sandwich Cookies Across China
- Missfresh Ltd (NASDAQ: MF) has partnered with OREO's parent company Mondelez International Inc (NASDAQ: MDLZ) to debut OREO's new range of sugar-free sandwich cookies - Oreo Zero across China. The financial terms of the deal were not disclosed.
- 08/19/2021
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MissFresh's Online Flower Sales up by 467% on Chinese Valentines' Day as Fresh Flower E-commerce Sees Record Growth
- BEIJING, Aug. 18, 2021 /PRNewswire/ -- MissFresh Limited ("MissFresh" or the "Company") (NASDAQ: MF), an innovative leader in China's neighborhood retail industry, saw its flower sales increase by 467% around the Qixi Festival, China's traditional "Valentine's Day" observed on the seventh day of the seventh lunar month (August 14th this year). "In the 17 cities that MissFresh operates in, flowers were all sold out during the Qixi Festival," Bo Qi, senior manager of MissFresh's fresh flower business, said of the company's record flower sales this year.
- 08/18/2021
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Missfresh Limited Announces Appointment of New Independent Director and Changes to Board Composition
- BEIJING, Aug. 16, 2021 (GLOBE NEWSWIRE) -- Missfresh Limited (“Missfresh” or the “Company”) (NASDAQ: MF), an innovator and leader in China's neighborhood retail industry, today announced the Company's board of directors (the “Board”) has approved the appointment of Mr. Shun Lam Steven Tang as an independent director of the Company and the following changes to the Board's composition, effective immediately.
- 08/16/2021
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MissFresh Officially Launches Full Range of Live Seafood, Kept Fresh With Advanced Quality Control
- BEIJING, Aug. 5, 2021 /PRNewswire/ -- MissFresh Limited ("MissFresh" or the "Company") (NASDAQ: MF), an innovator and leader in China's neighborhood retail industry, has officially launched a full range of more than 70 live seafood offerings – comprising fish, prawns, crustaceans and shellfish – on the MissFresh grocery delivery app for customers in Beijing, Shanghai, Tianjin, Hangzhou and Ningbo, after successfully soft launching a small variety since early 2021. The company has now also optimized quality control processes to uphold high standards of food safety during delivery.
- 08/05/2021
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MissFresh Launches in Ningbo, Adding 17th City as National Expansion Gains Pace
- NINGBO, China, July 31, 2021 /PRNewswire/ -- MissFresh Limited ("MissFresh" or the "Company") (NASDAQ: MF), an innovator and leader in China's neighborhood retail industry, has launched its Distributed Mini Warehouse-supported fast home delivery operations in Ningbo, offering a range of more than 4,300 products to be delivered in 39 minutes on average. With this latest expansion, MissFresh strengthens its Distributed Mini Warehouse (DMW) network – which integrates warehousing, sorting and distribution to streamline the retail distribution chain – in East China and now operates in 17 first- and second-tier cities.
- 07/31/2021
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Missfresh Partners With Mengniu Dairy To Expand Into China's Neighborhood Retail Sector
- Missfresh Limited (NASDAQ: MF) announced a partnership to provide the full range of Mengniu Dairy's 70 dairy products to bring more choices to the MissFresh app and WeChat Mini Program users. MissFresh will supply Mengniu's full range of products, including milk, yogurt, ice cream, and other beverages.
- 07/26/2021
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Wall Street Gives Thumbs Down To Online Grocers' Business Model
- Wall Street Gives Thumbs Down To Online Grocers' Business Model
- 07/08/2021
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Surging Online Grocer Dingdong In Focus After Missfresh's Stale Trading Debut
- Surging Online Grocer Dingdong In Focus After Missfresh's Stale Trading Debut
- 06/28/2021
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China Online Grocer MissFresh Drops 26% On Nasdaq Debut; CEO Sees Growth Prospects
- China neighborhood online grocer MissFresh added its name on Friday to the largest group of U.S. IPOs in 21 years in the second quarter.
- 06/27/2021
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