MindForge (MF)
Digital promotion and vehicle-risk tools for China’s property-and-casualty insurers.
Disc Medicine Presents Updated Positive Data from RALLY-MF Phase 2 Trial in Patients with Myelofibrosis (MF) and Anemia at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
Demonstrated meaningful, durable overall anemia responses across all patient subgroups, regardless of baseline transfusion status Anemia response was seen independent of concomitant JAK inhibitor therapy use WATERTOWN, Mass., June 02, 2026 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today presents updated data from the RALLY-MF Phase 2 trial of DISC-0974 in anemia of MF at the ASCO Annual Meeting in Chicago, IL.
Disc Medicine Presents Positive Updated Results from Phase 1b Trial in Patients with Myelofibrosis (MF) and Anemia in an Oral Presentation at the 66th American Society of Hematology (ASH) Annual Meeting
WATERTOWN, Mass., Dec. 08, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today presented positive updated results from a Phase 1b trial of DISC-0974 in patients with myelofibrosis (MF) and anemia. The data, presented in an oral session at the 2024 American Society of Hematology (ASH) annual meeting in San Diego, CA, demonstrated that treatment with DISC-0974 results in substantial reductions in hepcidin and increases in iron levels translating to positive impact on clinically meaningful measures of anemia across a broad range of patient types.
Missfresh Receives Delisting Notice from Nasdaq
BEIJING, Nov. 17, 2023 (GLOBE NEWSWIRE) -- Missfresh Limited (“Missfresh” or the “Company”) today announced that the equity financings and the business acquisition under the share purchase agreements, as previously announced on August 3, 2023, and the transactions under the share transfer agreement, as previously announced on August 7, 2023, have been terminated. On November 15, 2023, the Nasdaq Hearings Panel (the “Panel”) notified the Company that the Panel has determined to delist the Company's securities from The Nasdaq Stock Market LLC (“Nasdaq”) and suspend trading in those securities effective at the open of trading on Friday, November 17, 2023 (the “Decision”). Nasdaq will complete the delisting by filing a Form 25 Notification of Delisting with the SEC, after applicable appeal periods have lapsed.
Missfresh Limited Announces Results of Annual General Meeting
BEIJING, Sept. 15, 2023 (GLOBE NEWSWIRE) -- Missfresh Limited (“Missfresh” or the “Company”) (NASDAQ: MF) is pleased to announce that at its annual general meeting of shareholders held virtually today, shareholders of the Company approved each of the four proposed resolutions set out in the notice of annual general meeting (the “Meeting Notice”), namely, an ordinary resolution to increase the Company's authorized share capital, a special resolution to amend the Company's memorandum and articles of association to reflect such increase in the share capital and other changes, an ordinary resolution to approve the transaction contemplated under certain share transfer agreement entered into by and between the Company and certain other party thereto as announced by the Company on August 7, 2023, and an ordinary resolution to authorize the Company's directors, officers and agents to carry out the foregoing. The meeting notice had been furnished on August 18, 2023 to the Securities and Exchange Commission under cover of a Form 6-K and timely disseminated to shareholders and holders of the Company's American depositary shares prior to the meeting.
Missfresh Limited to Hold Annual General Meeting on September 15, 2023
BEIJING, China, Aug. 18, 2023 (GLOBE NEWSWIRE) -- Missfresh Limited (“Missfresh” or the “Company”) (NASDAQ: MF), today announced that it will hold an annual general meeting of shareholders (the “AGM”) virtually held at https://meeting.tencent.com/dw/9lPeKAxZAu6p on September 15, 2023 at 9:00 A.M. (Beijing time), for the purposes of considering and, if thought fit, passing each of the proposed resolutions set forth in the notice of the AGM (the “AGM Notice”). The AGM Notice, which contains details of these proposed resolutions, and the form of proxy cards for the AGM are available on the Company's investor relations website at https://ir.missfresh.cn and are also being furnished today on a Form 6-K to the U.S. Securities and Exchange Commission (“SEC”). The board of directors of the Company fully supports the proposed resolutions set out in the AGM Notice and recommends that shareholders and holders of the Company's American depositary shares (“ADSs”) vote in favor of these resolutions.
Missfresh Announces Entry into Share Transfer Agreement
BEIJING, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Missfresh Limited (“Missfresh” or the “Company”) (NASDAQ: MF), today announced that it entered into a share transfer agreement with Freshking Limited, a British Virgin Islands company wholly owned by Mr. Zheng Xu. The entry into this share transfer agreement and the transactions contemplated thereunder have been approved by the board of directors of the Company (the “Board”), as well as the audit committee and the special committee under the Board.
Missfresh Files Annual Report on Form 20-F for Fiscal Year 2022
BEIJING, Aug. 04, 2023 (GLOBE NEWSWIRE) -- Missfresh Limited (“Missfresh” or the “Company”) (NASDAQ: MF), today announced it filed its annual report on Form 20-F for the fiscal year ended December 31, 2022 with the U.S. Securities and Exchange Commission (“SEC”) on August 3, 2023. The annual report can be accessed on the Company's investor relations website at https://ir.missfresh.cn/ as well as the SEC's website at https://www.sec.gov/.
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.
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).
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.
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.
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.
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.
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.
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
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.
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.
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).
Why Missfresh Limited Stock Jumped Today
The Chinese penny stock jumped on a possible short squeeze.
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