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Consolidated Financial Results for the Fiscal Year Ended March 31, 2022

On April 28, 2022 NEC reported (Press release, NEC, APR 28, 2022, View Source [SID1234613084])

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1. Consolidated Financial Results for the Year ended March 31, 2022 (April 1, 2021 – March 31, 2022)
(1) Consolidated Operating Results
(2) Consolidated Financial Position
(3) Consolidated Cash Flows

2. Dividends
3. Consolidated Financial Results Forecast for the Fiscal Year Ending March 31, 2023 (April 1, 2022 – March 31, 2023)

1. Non-consolidated Financial Results for the Year Ended March 31, 2022 (April 1, 2021 – March 31, 2022)
(1) Non-consolidated Operating Results
(2) Non-consolidated Financial Position

*This consolidated financial results falls outside the scope of audit to be performed by certified public accountants or an audit firm.

*Explanation concerning the appropriate use of the financial results forecast and other special matters (Adjusted profit (loss)) "Adjusted operating profit (loss)" is an indicator for measuring underlying profitability in order to clarify the contribution of acquired companies to the NEC Group’s overall earnings. It is measured by deducting amortization of intangible assets recognized as a result of M&A and expenses for acquisition of companies (financial advisory fees and other fees) from operating profit (loss). Also, "Adjusted net profit (loss) attributable to owners of the parent" is an indicator for measuring underlying profitability attributable to owners of the parent. It is measured by deducting adjustment items of operating profit (loss) and corresponding amounts of tax and non-controlling interests from net profit (loss) attributable to owners of the parent. (Cautionary statement with respect to forward-looking statements) The forward-looking statements such as operating results forecast contained in this statements summary are based on the information currently available to NEC Corporation ("the Company") and certain assumptions considered reasonable. Actual operating results may differ significantly from these forecasts due to various factors.

For details, please refer to "3. Cautionary Statement with Respect to Forward-Looking Statements" on page 16. (How to obtain supplementary financial materials and information on the financial results briefing) On April 28, 2022, the Company will hold a financial results briefing for the institutional investors and analysts. Presentation materials will be posted on the company website after the release of financial results, and the presentation video and Q&A summary will be also posted on the company website promptly after the financial results briefing. In addition to the above, the Company periodically holds briefings on business and operating results for the individual investors. Presentation materials and Q&A summary will be posted on the company website promptly after the briefing. For the schedule and details, please check the company website.

Amgen reports first quarter 2022 financial results

On April 28, 2022 Amgen reported first quarter 2022 financial results (Filing, 3 mnth, MAR 31, Amgen, 2022, APR 28, 2022, View Source [SID1234613083]).

ShiftBio Partners with RoosterBio Inc. to Develop SBI-102 for Rare Diseases and Cancer

On April 27, 2022 ShiftBio reported its partnership with RoosterBio Inc. (Frederick, MD) for its first pipeline, SBI-102 (Press release, ShiftBio, APR 27, 2022, View Source;bmode=view&idx=11285502&t=board [SID1234629019]). This partnership cooperates to start clinical sample production of ShiftBio’s first driving pipeline for rare diseases and cancer.

RoosterBio is a leading supplier of human mesenchymal stem cells (h-MSCs) not only with broad knowledge and expertise in bioprocess development services but also with their success in producing cell and media products with FDA-approved type II master files. Through this partnership, RoosterBio and ShiftBio will comprehensively carry out all the process optimization required to produce exosomes expressing a therapeutic ligand at a scalable GMP level by minimizing the risk with bilateral confirmation tests and utilizing their ability to fulfill the current regulation criteria at a very high level.

This strategic collaboration of the knowledge, expertise, and experience aimed to overcome existing know-how limitations of such a recently emerged drug modality in commercial production. ShiftBio applies the regulatory-supported latest innovations to its process and minimizes the years-long new drug development with its perfectly coordinated production strategy that brings the latest technologies of Asia, Europe, and the U.S together. Working with the aim and motto of giving patients a second chance from the very beginning, ShiftBio plans to reach this goal with the right strategic decisions as soon as possible to not lose another incurable patient.

Allogene Therapeutics to Report First Quarter 2022 Financial Results on May 4, 2022

On April 27, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will report first quarter 2022 financial results on Wednesday, May 4, 2022 after the close of the market (Press release, Allogene, APR 27, 2022, View Source [SID1234616274]). The announcement will be followed by a live audio webcast and conference call at 2:00 PM Pacific Time/5:00 PM Eastern Time.

Audio Webcast
The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

Allogene Therapeutics Receives FDA Orphan-Drug Designation for ALLO-605, its First TurboCAR™ T Cell Product Candidate, for the Treatment of Multiple Myeloma

On April 27, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to ALLO-605, the Company’s next-generation AlloCAR T product candidate targeting BCMA for the treatment of multiple myeloma (Press release, Allogene, APR 27, 2022, View Source [SID1234616273]).

ALLO-605 is the Company’s first TurboCAR product candidate. TurboCAR is a proprietary, next generation platform technology based on a programmable cytokine signaling, designed to control T cell exhaustion and to improve T cell function and potency. These properties may enable CAR T products to succeed in more difficult to treat hematologic malignancies and solid tumors. The FDA granted Fast Track designation to ALLO-605 in Q2 2021 based on the potential for the product candidate to address an unmet need for patients who have failed other standard multiple myeloma therapies. The Phase 1 study evaluating ALLO-605 is ongoing.

"Orphan-drug designation marks an important step towards developing our anti-BCMA portfolio for patients with multiple myeloma and making allogeneic CAR T products readily available for patients," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "We look forward to providing an update on our BCMA clinical assets by the end of the year with an eye toward prioritizing a strategy for the next stage of development."

Orphan-drug designation is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the U.S. ODD granted therapies entitle companies to development incentives including tax credits for clinical testing and prescription drug user fee exemptions. If a product that has ODD subsequently receives the first FDA approval for the designated disease, the FDA may not approve any other applications to market the same biologic for the same indication for seven years, except in limited circumstances. ODD does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.

About ALLO-605
ALLO-605, a next-generation AlloCAR T known as a TurboCAR, is an investigational product that targets the B-cell maturation antigen (BCMA) for the treatment of patients with relapsed/refractory multiple myeloma and other BCMA-positive malignancies. This study uses ALLO-647, Allogene’s proprietary monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen. ALLO-605 incorporates Allogene’s proprietary TurboCAR technology, which allows for cytokine activation signaling to be engineered selectively into CAR T cells. Preclinical results with ALLO-605 were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2020. In June 2021, ALLO-605 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed/refractory multiple myeloma. The Phase 1 study evaluating ALLO-605 is underway.