On May 12, 2021 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, reported positive preliminary results from its Phase 2 clinical trial of MGTA-145 plus plerixafor in patients with multiple myeloma, which were accepted for presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress, to be held virtually June 9-17, 2021 (Press release, Magenta Therapeutics, MAY 12, 2021, View Source [SID1234579792]). Magenta also provided initial direction regarding the acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients it expects to evaluate in its planned clinical trial with MGTA-117.

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Multiple Myeloma Phase 2 Clinical Trial

The investigator-initiated, 25-patient Phase 2 open-label clinical trial, ongoing at Stanford University School of Medicine, is designed to evaluate the ability of MGTA-145, in combination with plerixafor, to mobilize and collect stem cells for autologous stem cell transplant in patients with multiple myeloma.

Preliminary results:

All patients (10/10) met the primary endpoint of mobilization and collection of 2 million CD34+ stem cells per kg in up to two days of same-day mobilization and apheresis. Nine of 10 patients achieved the primary endpoint in a single day.
The median number of stem cells collected in one day was 5.4 million CD34+ stem cells per kg.
Patients could also be successfully mobilized and apheresed on a second day, if needed, based upon protocol requirements. The median number of stem cells collected on day 1 and 2 (if needed) was 7.1 million CD34+ stem cells per kg in all patients. Current standard of care with G-CSF regimens require a minimum of five days of dosing to initiate stem cell collection.
All transplanted patients (6/6) successfully engrafted, with median recovery of neutrophils after 12 days and platelets after 17 days, which are within transplant expectations in multiple myeloma.
The CD34+ stem cells collected were enriched for CD90 expression (31% of CD34 cells were CD34+CD90+), a stem cell population associated with durable engraftment, which is three-fold greater than observed with G-CSF historically.
The regimen of MGTA-145 and plerixafor was well tolerated. Acute, transient, MGTA-145-related grade 1 bone or musculoskeletal pain was observed in 40% of patients following MGTA-145 infusion.
This study has broad and clinically representative inclusion criteria and is enrolling patients that represent the general transplant eligible population of patients with multiple myeloma, some of whom may have additional risk factors that may impact stem cell collection. Risk factors can include myeloma-directed therapies that are known to impact stem cell collection, previous malignancy treated with chemotherapy and/or radiation and other co-morbid conditions. Mobilization agents may be less effective in patients with multiple risk factors.

"These preliminary results are encouraging, given the expected mobilization challenges present in the multiple myeloma patient population," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "A patient’s ability to mobilize is highly contingent on a variety of risk factors, which is particularly relevant for blood cancer patients. These initial results provide insight into MGTA-145 plus plerixafor’s ability to improve the approach to mobilization and collection, and its potential to be a first-line mobilization drug in this and other disease areas."

"Based on this initial data set, MGTA-145 combined with plerixafor has shown promising results for rapid stem cell mobilization in patients with multiple myeloma," said John Davis Jr., M.D., M.P.H., M.S., Head of Research & Development and Chief Medical Officer, Magenta Therapeutics.

This study is being conducted at Stanford University School of Medicine and is led by Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy at Stanford Medicine.

EHA Poster Presentation (June 11, 2021)
Title: Phase 2 Study of MGTA-145 + Plerixafor for Rapid and Reliable Hematopoietic Stem Cell (HSC) Mobilization for Autologous Stem Cell Transplant in Multiple Myeloma
Author: Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University School of Medicine
Date/Time: E-posters to be available in the EHA (Free EHA Whitepaper) Congress virtual platform Friday, June 11 at 3:00am EDT / 9:00am CEST.

This trial continues to enroll patients and Magenta expects to report additional data at the EHA (Free EHA Whitepaper) Congress, as well as at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held virtually June 4-8, 2021.

Conference Call & Webcast Details

The Company will host a conference call and webcast today at 4:30pm EDT to review the preliminary results from the multiple myeloma Phase 2 clinical trial. The live webcast of the conference call may be accessed by visiting the "Events & Presentations" page in the Investors & Media section of the Magenta Therapeutics website at View Source The live teleconference may be accessed by dialing (866) 688-5232 (domestic) or (409) 217-8328 (international) and entering conference ID: 7273937. An archived version of the call will be available on the website for 90 days.

Planned MGTA-117 Clinical Study

Magenta is on track to file an Investigational New Drug (IND) application for MGTA-117, a potential first-in-class drug for targeted patient conditioning, in June 2021. In preparation for the filing, Magenta has finalized its proposed clinical trial study design which incorporates FDA feedback from pre-IND communications. Magenta anticipates starting the Phase 1/2 dose escalation study by evaluating the safety, pharmacokinetics and pharmacodynamics of MGTA-117 as a single agent in a relapsed/refractory AML and MDS patient population. Magenta will also monitor for anti-tumor activity in this patient subset, which is a population that is not traditionally eligible for stem cell transplant. Magenta expects to work with the FDA on an ongoing basis to transition the study to transplant-eligible patients after adequate data related to the safety, pharmacokinetics and pharmacodynamics of MGTA-117 have been collected in the relapsed/ AML and MDS patient population.

On May 12, 2021 Magenta Therapeutics, Inc. (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported that it has agreed to sell approximately 9,600,000 shares of its common stock to certain institutional investors in a private placement (Press release, Magenta Therapeutics, MAY 12, 2021, View Source [SID1234579791]). Magenta anticipates aggregate gross proceeds from the offering will be $86.4 million, before deducting estimated offering expenses payable by the Company, based on the offering price of $9.00 per share. The financing syndicate includes Deep Track Capital, L.P., TCG X, Great Point Partners, LLC, OrbiMed and Janus Henderson Investors. The closing is anticipated to occur on May 14, 2021, subject to customary closing conditions. Magenta intends to use the net proceeds from the offering for general corporate purposes and working capital.

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The securities are being sold in a private placement and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. The Company has agreed to file a resale registration statement with the Securities and Exchange Commission (the "SEC"), for purposes of registering the resale of the shares of common stock issued or issuable in connection with the offering.

Important Information

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

On May 12, 2021 Labcorp (NYSE: LH) ("Labcorp") reported that it plans to offer, subject to market and other conditions, senior notes that are expected to be issued in two tranches (the "Notes") (Press release, LabCorp, MAY 12, 2021, View Source [SID1234579790]). The Notes will be senior unsecured obligations and will rank equally with Labcorp’s existing and future senior unsecured debt.

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Labcorp expects to use the net proceeds of the Notes offering to redeem, prior to maturity, its outstanding 3.20% Senior Notes due Feb. 1, 2022 and 3.75% Senior Notes due Aug. 23, 2022.

The joint book-running managers for the offering are BofA Securities, KeyBanc Capital Markets, and Wells Fargo Securities. The offering will be made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-234633) filed with the Securities and Exchange Commission (the "SEC") on Nov. 12, 2019. A copy of the prospectus and related prospectus supplement may be obtained without charge from the SEC. Alternatively, a copy of the prospectus and related prospectus supplement may be obtained from BofA Securities by calling toll-free 1-800-294-1322, from KeyBanc Capital Markets by calling toll-free 1-866-227-6479, or from Wells Fargo Securities by calling toll-free 1-800-645-3751.

This announcement does not constitute an offer to sell or a solicitation of an offer to buy the Notes or any other securities, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The offering of these securities may be made only by means of the prospectus supplement and the accompanying prospectus.

On May 12, 2021 Kuraray reported that Financial Results for the First Quarter of the Fiscal Year Ending December 31, 2021 (January 1, 2021 to March 31, 2021) (Press release, Kuraray, MAY 12, 2021, https://pdf.irpocket.com/C3405/eq9A/Kj61/GizM.pdf [SID1234579789])

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1. Consolidated Financial Results for the First Quarter of the Fiscal Year Ending December 31, 2021 (January 1, 2021 to March 31, 2021)

(1) Consolidated Operating Results (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)

(2) Consolidated Financial Position2. Dividends 3. Forecasts of Consolidated Financial Results for the Fiscal Year Ending December 31, 2021 (January 1, 2021 to December 31, 2021) (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)

1. Qualitative Information regarding Business Results
1) Overview of Consolidated Business Results In the first quarter of fiscal 2021 (January 1, 2021–March 31, 2021), the world economy is still feeling the effects of the COVID-19 pandemic, and the outlook remains unclear. Amid these circumstances, the Group’s business results continued to recover owing to an increase in demand for at-home consumption due to the pandemic and an increase in automotive-related demand.

Consequently, consolidated operating results for the first quarter of fiscal 2021 are as follows: net sales rose ¥7,470 million, or 5.5%, compared with the previous fiscal year to ¥144,398 million; operating income increased ¥4,814 million, or 40.2%, to ¥16,786 million; ordinary income increased ¥4,962 million, or 43.9%, to ¥16,268 million; and net income attributable to owners of the parent decreased ¥1,422 million, or 21.2%, to ¥5,282 million. Furthermore, in the first quarter, we recorded a loss on litigation of ¥3,054 million related to a fire that occurred at our U.S. subsidiary in May 2018. We also recorded a disaster loss of ¥3,016 million due mainly to the suspension of production for some equipment at our U.S. subsidiary caused by a severe cold wave in the southern United States in February.

The Group’s long-term vision for its 100th anniversary coming up in 2026, Kuraray Vision 2026, is to become a "Specialty Chemical Company, growing sustainably by incorporating new foundational platforms into its own technologies." We will continue striving to optimize our business portfolio by steadily taking specific measures based on the three basic policies of Kuraray Vision 2026: pursuing competitive superiority, expanding new business fields and enhancing comprehensive strength of the Kuraray Group. We formulated a single-year management plan for fiscal 2021 and will focus on safe and stable operations amid the pandemic as well as thoroughly implement various measures decided on during the period of the previous medium-term management plan "PROUD 2020." At the same time, we will move ahead with formulating the next medium-term management plan, which is set to start in fiscal 2022. In the Functional Materials segment, due to an organizational reform on January 1, 2021, we integrated the Calgon Carbon Division and Carbon Materials Division, whose core products are activated carbon, into the Environmental Solutions Division. Results by Business Segment Vinyl Acetate Sales in this segment increased 13.0% year on year to ¥72,175 million, and segment income rose 59.9% year on year to ¥13,415 million

(1) Sales of PVA resin increased as global demand began to recover though overall business was affected by the U.S. cold wave. Sales of optical-use poval film were brisk due to an increase in demand for LCD panels, especially large displays, from the second half of the previous fiscal year. The sales volume of PVB film rose on the back of a recovery in demand for both construction and automotive applications. Sales of water-soluble PVA film steadily expanded for use in unit dose detergent packets, including for dish detergents, as more customers stay at home due to the COVID-19 pandemic.

(2) The sales volume of EVAL ethylene vinyl alcohol copolymer (EVOH resin) increased as food packaging applications remained firm and demand for gas tank applications recovered, but overall performance was affected by the U.S. cold wave. Isoprene Sales in this segment increased 13.2% year on year to ¥14,894 million, and segment income fell 3.0% year on year to ¥3,046 million.

(1) The sales volume of isoprene chemicals and SEPTON thermoplastic elastomer increased by a demand recovery mainly in China and the rest of Asia, but performance was affected by higher raw material and fuel prices.2) Sales of GENESTAR heat-resistant polyamide resin remained brisk for electric and electronic device applications and automotive applications amid growing demand. Functional Materials Sales in this segment decreased 1.5% year on year to ¥30,294 million, and segment income fell 16.3% year on year to ¥1,061 million.

(1) In the methacrylate business, sales for sign applications were weak despite an increase in sales of spatter-blocking barrier panels and displays.
(2) In the medical business, the dental materials business saw brisk sales, mainly in Europe and the United States.
(3) In the environmental solutions business, shipments decreased, especially for industrial applications. Fibers and Textiles Sales in this segment fell 5.2% year on year to ¥13,721 million while segment income decreased 52.4% year on year to ¥435 million

1) Sales of CLARINO man-made leather remained stable amid signs of a recovery in demand, especially for shoe applications in Asia and luxury good applications in Europe
2) In fibers and industrial materials, sales of KURALON were lower than the previous year despite a recovery in demand, which had fallen in the second half of the previous year
3) In consumer goods and materials, the sales volume of KURAFLEX decreased as 5 demand for counter cloths for the restaurant industry remained weak despite an increase in sales volume for mask-related applications.Trading In fiber-related businesses, sales stagnated, especially for sports clothing. Sales of resins and chemicals remained favorable due to an increase in demand in Japan and Asia, including China. As a result, segment sales increased 10.8% year on year to ¥32,972 million, and segment income rose 11.8% to ¥1,074 million

(2) Overview of Financial Position Total assets decreased ¥2,877 million from the end of the previous fiscal year to ¥1,048,707 million mainly because of a ¥30,184 million decrease in cash and cash deposits and a ¥5,794 million decrease in short-term investment securities, despite a ¥6,845 million increase in construction in progress, a ¥5,067 million increase in notes and accounts receivable-trade, a ¥4,615 million increase in inventories, a ¥4,608 million increase in machinery, equipment and vehicles, a ¥3,314 million in other current assets accompanying mainly an increase in other accounts receivable, and a ¥2,410 million increase in goodwill due to the effects of foreign exchange rates. Total liabilities decreased ¥25,709 million to ¥510,394 million due to factors that included the redemption of commercial paper totaling ¥20,000 million and a ¥11,684 million decrease in other current liabilities accompanying mainly a decrease in otheraccounts payable, despite a ¥3,626 million increase in notes and accounts payable–trade. Net assets rose ¥22,831 million to ¥538,312 million. Equity attributable to owners of the parent amounted to ¥520,151 million, for an equity ratio of 49.6%.

(3) Basis for the Revision in Forecasts, Including Consolidated Operating Results Forecasts In the consolidated first quarter, shipments in many of Kuraray’s businesses increased due to growth in demand, including for mainstay applications for automobiles, displays, and electronic and electric devices. We assume that demand will remain firm in the second quarter as well. Based on these circumstances, the forecast of consolidated operating results for the second quarter of fiscal 2021 (January 1, 2021 to June 30, 2021) is as shown below. The revised cumulative consolidated operating results forecast for the second quarter of the fiscal year ending December 31, 2021 (January 1, 2021 to June 30, 2021) is as follows.

Furthermore, although we recorded an extraordinary loss in the consolidated first quarter related to the litigation over the fire at the U.S. subsidiary, the litigation is still ongoing.

On May 12, 2021 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported its first quarter 2021 financial results and corporate highlights (Press release, Kezar Life Sciences, MAY 12, 2021, View Source [SID1234579788]).

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"Last quarter saw excellent execution by the Kezar team across both of our programs. We look forward to sharing data this June from the completed Phase 1b portion of the MISSION study of KZR-616 in SLE patients, followed by an interim review of the Phase 2 portion of MISSION in LN patients in the fourth quarter. Our conviction continues to deepen that immunoproteasome inhibition has the potential to be a powerful, differentiated treatment approach for patients with autoimmune diseases," said John Fowler, Kezar’s Co-founder and Chief Executive Officer. "In addition, we are on track to submit an IND for KZR-261, our first-in-class protein secretion inhibitor, in mid-2021 and commence a Phase 1 study in solid tumors shortly thereafter."

Clinical Highlights & Updates

KZR-616: Selective Immunoproteasome Inhibitor

MISSION – Phase 1b/2 clinical trial in patients with systemic lupus erythematous (SLE) and lupus nephritis (LN), respectively (NCT03393013)

The last patient from the MISSION Phase 1b completed treatment in February 2021, and final clinical data from this 25-week safety and tolerability study of up to 75 mg weekly of KZR-616 in 47 patients with SLE will be presented during the European Congress of Rheumatology (EULAR 2021) in June.
The amended Phase 2 open-label portion of the MISSION trial in patients with active, proliferative lupus nephritis opened for enrollment in August 2020 and is actively recruiting. The primary efficacy endpoint for the trial is the proportion of patients achieving a renal response measured by a 50% or greater reduction in urine protein to creatinine ratio (UPCR) at six months.
Interim data are expected in late 2021, and topline data are expected in the first half of 2022.
PRESIDIO – Phase 2 clinical trial in patients with dermatomyositis (DM) and polymyositis (PM) (NCT04033926)

The PRESIDIO Phase 2, placebo controlled cross-over trial of KZR-616 in DM and PM is actively enrolling. Additionally, a 12-month open-label extension study is open to patients completing the 32-week placebo-controlled trial (NCT04628936).
Topline data are expected in the first half of 2022.
Protein Secretion Program

KZR-261 is a first-in-class protein secretion inhibitor which targets the Sec61 translocon and has demonstrated broad anti-tumor activity in preclinical models of both solid and hematologic malignancies.
Pending successful completion of drug product manufacturing, submission of an Investigational New Drug (IND) application for KZR-261 is anticipated in mid-2021. The Phase 1 clinical trial will evaluate pharmacokinetics, safety, and tolerability in patients with solid tumors as well as preliminary signs of efficacy in tumor-specific expansion cohorts. The trial is expected to commence shortly after the IND becomes effective.
Two abstracts featuring Kezar’s small molecule inhibitors of the Sec61 translocon were presented in April during the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2021 Virtual Annual Meeting.
Corporate Update

In May 2021, Kezar was recognized as a winner of the 2021 Bay Area Best Places to Work, an awards program presented by the San Francisco Business Times and the Silicon Valley Business Journal.
Financial Results

Cash, cash equivalents and marketable securities totaled $142.3 million as of March 31, 2021, compared to $140.4 million as of December 31, 2020. The increase in cash, cash equivalents and marketable securities was primarily attributable to the net proceeds from the issuance of common stock under the "at-the-market" Sales Agreement with Cowen and Company, LLC, offset by cash used by the company in operations to advance its clinical-stage programs and preclinical research and development.
Research and development expenses for the first quarter of 2021 increased by $1.8 million to $9.3 million compared to $7.5 million in the first quarter of 2020. This increase was primarily related to advancing the KZR-616 clinical program in multiple indications and the protein secretion preclinical program.
General and administrative expenses for the first quarter of 2021 increased by $0.8 million to $3.8 million compared to $3.0 million in the first quarter of 2020. The increase was primarily due to an increase in personnel expenses and stock-based compensation as a result of an increase in headcount and salaries and an increase in the cost of directors’ and officers’ liability insurance.
Net loss for the first quarter of 2021 was $13.0 million, or $0.25 per basic and diluted common share, compared to a net loss of $10.0 million, or $0.30 per basic and diluted common share, for the first quarter of 2020.
Total shares of common stock outstanding were 48.1 million shares as of March 31, 2021. Additionally, there were outstanding pre-funded warrants to purchase 3.8 million shares of common stock at an exercise price of $0.001 per share and outstanding options to purchase 7.1 million shares of common stock at a weighted-average exercise price of $5.90 per share as of March 31, 2021.
About KZR-616

KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1a and 1b clinical trials provide evidence that KZR-616 exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases. Phase 2 trials are underway in severe autoimmune diseases.

About KZR-261

KZR-261, a novel, first-in-class protein secretion inhibitor, is the first clinical candidate to be nominated from Kezar’s research and discovery efforts targeting protein secretion pathway. KZR-261 is a broad-spectrum anti-tumor agent that acts through direct interaction and inhibition of Sec61 activity. The compound was discovered by Kezar through a robust medicinal chemistry campaign in which several scaffolds were progressed through the company’s proprietary platform evaluating Sec61 modulation. As a result, Kezar has established a broad library of protein secretion inhibitors. KZR-261 has demonstrated several encouraging properties that lead to its potential to be an anti-cancer agent for the treatment of solid and hematologic malignancies. An IND submission in solid tumors is expected to be filed in mid-2021.

About Lupus Nephritis

Lupus nephritis is one of the most serious complications of systemic lupus erythematosus. LN is a disease comprising a spectrum of vascular, glomerular and tubulointerstitial lesions and develops in approximately 50% of SLE patients within 10 years of their initial diagnosis. LN is associated with considerable morbidity, including an increased risk of end-stage renal disease requiring dialysis or renal transplantation and an increased risk of death. There are limited approved therapies for the treatment of LN. Management typically consists of induction therapy to achieve remission and long-term maintenance therapy to prevent relapse.

About Dermatomyositis and Polymyositis

Dermatomyositis and Polymyositis are two of the five types of autoimmune myositis diseases. Both are chronic, debilitating, inflammatory autoimmune myopathies that are distinguished by inflammation of the muscles as well as the skin (in DM). Approximately 30,000 to 120,000 people in the United States are living with these severe and progressive inflammatory myopathies that are characterized by marked morbidity and associated mortality. While debilitating muscle weakness is the hallmark of these myopathies, including compromised muscles of respiration, other internal organ system dysfunctions can be equally disabling. The aim of treatment for these diseases is to suppress inflammation, increase muscle strength and prevent long-term damage to muscles and extramuscular organs; however, treatment options are limited for DM, and there are currently no approved treatments for PM.