On February 1, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported plans to participate in the virtual BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference (Press release, Pulse Biosciences, FEB 1, 2022, View Source [SID1234607633]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Management is scheduled to conduct meetings with investors during the conference on Tuesday, February 15th and Wednesday, February 16th, 2022.

On February 1, 2022 Global pharma major, Lupin Limited (Lupin) reported that they have entered into a License, Supply and Technology Sharing agreement with Axantia Holding (Axantia), a leading pharmaceutical company in the region operating through its pharmaceutical subsidiaries; Pharma International Company and Med City Pharmaceutical Industries (Press release, Lupin, FEB 1, 2022, View Source [SID1234607548]). Under the terms of Agreement, Axantia will register, distribute and market biosimilar Pegfilgrastim Drug Product in certain territories including Saudi Arabia, certain GCC countries, Jordan, Lebanon, Iraq, Sudan, Libya and Algeria.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Lupin had earlier received the U.S. FDA acceptance for review of the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.

Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy.

On February 1, 2022 Biogen Inc. (Nasdaq: BIIB) reported that it exercised its option to participate in the development and commercialization of mosunetuzumab (Press release, Biogen, FEB 1, 2022, View Source [SID1234607566]). Biogen will pay a $30 million one-time option fee to Genentech, a member of the Roche Group, as part of the companies’ long-standing collaboration on antibodies targeting CD20.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Mosunetuzumab is a CD20xCD3 T-cell engaging bispecific antibody in development for the treatment of people with B-cell non-Hodgkin’s lymphoma (NHL), including follicular lymphoma (FL)1 and diffuse large B-cell lymphoma (DLBCL). In June 2020, mosunetuzumab was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed/refractory (R/R) FL who have received at least two prior systemic therapies.

Genentech plans to complete a Biologics License Application (BLA) submission to the FDA in the near future for approval consideration from the GO29781 study investigating mosunetuzumab in patients with R/R FL. If approved, mosunetuzumab has the potential to be a first-in-class CD20xCD3 T-cell engaging bispecific antibody in NHL. Roche recently submitted the initial marketing authorization application for mosunetuzumab to the European Medicines Agency (EMA), with the hope to bring this drug as soon as possible to people with NHL. In addition, mosunetuzumab recently began a Phase 1b trial in patients with systemic lupus erythematosus2.

As a part of the option exercise, Biogen will pay a $30 million one-time option fee to Genentech and will pay for a portion of the mosunetuzumab development expenses incurred during 2021. Biogen will have joint decision-making rights related to development and commercialization of mosunetuzumab and Genentech will continue to lead the strategy and implementation of the program.

Biogen will share in the operating profits and losses of mosunetuzumab in United States in the low to mid 30% range and is eligible to receive low single-digit royalties on sales outside the United States.

On February 1, 2022 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported a collaboration with Rutgers, The State University of New Jersey (Press release, NexImmune, FEB 1, 2022, View Source [SID1234607582]). The collaboration will focus on the discovery and development of novel therapies targeting immune checkpoint proteins for the treatment of neuroendocrine tumors and other cancers. Dr. Steven K. Libutti, Director of Rutgers Cancer Institute of New Jersey, Vice Chancellor of Cancer Programs, Rutgers Biomedical and Health Sciences, and Senior Vice President of Oncology Services, RWJBarnabas Health, will be the principal investigator.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Neuroendocrine tumors are being diagnosed with increasing frequency in the United States and represent a large unmet medical need," said Dr. Jerry Zeldis, NexImmune’s Executive Vice President, R&D. "With Dr. Libutti, we hope to discover and develop novel treatments utilizing our AIM ACT platform that may improve the timely and effective treatment of neuroendocrine neoplasia."

"HHLA2 and B7x are expressed by a number of tumors and can modulate cancer development and progression by inhibiting T cell function. Our work with NexImmune allows us to utilize a novel immunotherapy platform with the goal of improving survival using better and safer treatments in patients with few treatment options," stated Dr. Libutti.

On January 28, 2022 Nippon Kayaku reported that Summary of Consolidated Financial Results [Japanese GAAP] For the Third Quarter of the Fiscal Year Ending March 31, 2022 (Press release, Nippon Kayaku, FEB 1, 2022, View Source [SID1234607549])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

1. Consolidated Business Results for the First Three Quarters of the Fiscal Year Ending March 31, 2022 (April 1, 2021–December 31, 2021)
(2) Consolidated Financial Position

2. Status of Dividends3. Consolidated Business Results Forecasts for the Fiscal Year Ending March 31, 2022 (April 1, 2021–March 31, 2022)

Notes
(1) Significant changes in subsidiaries during the first three quarters (changes in designated subsidiaries that result in changes in scope of consolidation): None
(2) Adoption of special accounting methods for presenting the quarterly consolidated financial statements: None
(3) Changes to accounting policies and estimates and restatements

[1] Changes to accounting policies associated with revision of accounting standards or similar items: Yes
[2] Changes other than
[1]: None
[3] Changes to accounting estimates: None
[4] Restatements: None Note: See

"2. Quarterly Consolidated Financial Statements and Notes to Quarterly Consolidated Financial Statements,
(3) Notes to Quarterly Consolidated Financial Statements (Changes to Accounting Policies)" on page 8 for further details.
(4) Number of shares issued (common stock)
[1] Number of shares issued at end of the fiscal period (including treasury stock) As of December 31, 2021: 177,503,570 shares As of March 31, 2021: 177,503,570 shares
[2] Number of treasury stock at end of the fiscal period As of December 31, 2021: 9,257,789 shares As of March 31, 2021: 6,710,650 shares
[3] Average number of shares during the fiscal period (cumulative) First three quarters of fiscal year ending March 31, 2022: 169,174,386 shares First three quarters of fiscal year ended March 31, 2021: 170,793,503 shares

*Quarterly summary financial statements are not subject to audit by a certified public accountant or audit firm. *Analysis related to appropriate use of the business results forecasts, and other notes (Disclaimer concerning forward-looking statements) The information in this report constitutes forward-looking statements regarding future events and performance.

This information is based on the beliefs and assumptions of management in light of information currently available to it at the time of announcement and subject to a number of uncertainties that may affect future results. Actual business results may differ substantially from the forecasts herein due to various factors. For matters pertaining to business forecasts, please refer to
"(3) Analysis of Forward-looking Statements, Including Consolidated Business Forecasts" on page 3 of the Supplementary Information.