On February 2, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for the first nine months (April 1, 2021 – December 31, 2021) of the fiscal year 2021 (FY2021) ending March 31, 2022 (Press release, Astellas, FEB 2, 2022, View Source [SID1234607594]).

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Consolidated financial results for the first nine months of FY2021 (core basis)
1. Qualitative information on consolidated financial results for the first nine months of FY2021
(1) Business performance

Revenue
-Main products XTANDI for the treatment of prostate cancer, XOSPATA for the treatment of acute myeloid leukemia and PADCEV for the treatment of urothelial cancer showed steady growth as expected. In addition, the sales growth of EVRENZO for the treatment of renal anemia, Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB") and EVENITY for the treatment of osteoporosis contributed to revenue growth as well.
-Moreover, another factor for the increase in sales in the first nine months of FY2021 was the sales of pharmacologic stress agent Lexiscan returning to prepandemic level which decreased mainly in the first three months of the previous fiscal year by the impact of the spread of COVID-19.
-The sales growth of the products above offset the sales decrease mainly due to the termination of sales agreements for Celecox for the treatment of inflammation and pain and Lipitor for the treatment of hypercholesterolemia, and the divestiture of Eligard for the treatment of prostate cancer.

As a result of the above, revenue in the first nine months of FY2021 increased by 5.5% compared to those in the corresponding period of the previous fiscal year ("year-on-year") to ¥992.3 billion.

Core operating profit / Core profit
-Gross profit increased by 6.0% year-on-year to ¥798.2 billion. The cost-to-revenue ratio fell by 0.4 percentage points year-on-year to 19.6%, mainly due to changes in product mix.
-Selling, general and administrative expenses increased by 11.9% year-on-year to ¥406.4 billion. The total amount increased mainly due to the increase of copromotion fees associated with the growth of sales of XTANDI in the United States (increase of ¥18.5 billion year-on-year), impact of the foreign exchange rates (increase of ¥16.5 billion year-on-year), investment in Digital Transformation (increase of approximately ¥6.0 billion year-on-year), and the increase in sales promotion expenses for new product launch readiness (increase of approximately ¥2.5 billion year-on-year), despite a decrease in expenses due to the global optimization of personnel aligned with transformation of product portfolio (decrease of approximately ¥5.0 billion year-on-year). Selling, general and administrative expenses, excluding co-promotion fees of XTANDI in the United States, increased by 9.1% year-on-year to ¥297.7 billion.
-Research and development (R&D) expenses increased by 5.2% year-on-year to ¥177.6 billion. While there was a decrease in development expenses for fezolinetant, a selective neurokinin-3 receptor antagonist, for which patient enrollment in Phase III trials in the United States and Europe has been completed, the total amount increased mainly due to increases in development expenses for zolbetuximab, an anti-Claudin 18.2 monoclonal antibody and R&D investment for Rx+ business (related to iota). 3
-Amortisation of intangible assets increased by 17.1% year-on-year to ¥20.2 billion.
-Gain on divestiture of intangible assets was ¥24.1 billion. Including such as transfer of five products to Cheplapharm which were sold in Europe and other regions (¥12.3 billion), transfer of a pipeline asset (¥9.2 billion) and transfer of Bendamustine (¥2.0 billion).

As a result of the above, core operating profit increased by 8.0% year-on-year to ¥220.0 billion, and core profit increased by 1.8% year-on-year to ¥169.7 billion.

Impact of exchange rate on financial results
The exchange rates for the yen in the first nine months of FY2021 are shown in the table below. The resulting impacts were a ¥42.8 billion increase in revenue and a ¥15.4 billion increase in core operating profit compared with if the exchange rates of the first nine months of FY2020 were applied.

On February 1, 2022 FIMECS, Inc. (CEO: Yusuke Tominari, Ph.D., "FIMECS") a private biotechnology company creating a new class of drugs based on targeted protein degradation, reported that FIMECS has entered into a research collaboration with Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") on small molecule protein degraders against multiple targets for a multi-year period (Press release, FIMECS, FEB 1, 2022, View Source [SID1234630696]). The collaboration will leverage FIMECS’ expertise in targeted protein degradation and its proprietary RaPPIDS platform and Astellas’ scientific, regulatory, and clinical capabilities to accelerate the development of life-saving medicines to patients around the world.

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Under the terms of the agreement, FIMECS will conduct research activities on multiple targets and Astellas will advance candidates for development and potential commercialization. Upon designation of a clinical development candidate, Astellas has the option to exclusively license degrader molecules against the designated target. FIMECS will receive an upfront payment and funding to support Astellas-related research. Additionally, FIMECS could earn from potential payments based upon the successful achievement of specified research, development, regulatory, and commercial milestones for all the targets initially selected by Astellas. In addition, FIMECS will receive single digit tiered royalties on future net sales on any products that may result from this collaboration. Astellas may, at its discretion, elect to expand the collaboration to include additional disease targets. This decision would trigger an additional one-time payment, as well as potential payment of milestones and royalties on a product-by-product basis.

"We are thrilled to partner with Japanese top-tier global pharmaceutical company, Astellas to combine their deep understanding of biology and strong clinical development capabilities with FIMECS’ proprietary protein degrader platform," said Yusuke Tominari, Ph.D., CEO, FIMECS. "We have already identified unique E3 ligase binders and established highly effective synthetic method as a degrader discovery platform, RaPPIDS. We are very pleased that our platform has been wellreceived by the organization. This strategic partnership will broaden the application of targeted protein degradation to address diseases with high unmet medical needs. We hope to continue this collaboration with Astellas with the goal of potentially delivering life-saving medicines to patients all over the world."

On February 1, 2022 The Management Board and Supervisory Board of 4SC AG (FSE Prime Standard: VSC) reported that as a result of a review of more recent clinical data 4SC discontinues the development program for domatinostat, an orally administered small molecule class I selective HDAC inhibitor (Press release, 4SC, FEB 1, 2022, View Source [SID1234608076]).

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4SC will now focus its resources completely on resminostat and on seeing an outcome to the ongoing pivotal RESMAIN study in CTCL and prepare for its commercialization in case of positive data. 4SC continues to be well funded and expects to have sufficient cash in-hand to obtain topline results from the RESMAIN study.

Jason Loveridge, Ph.D., CEO of 4SC commented: "As a company, we understand that developing new medicines for patients suffering from malignant diseases is an important, but difficult undertaking. Accordingly, we continually evaluate our development programs as data emerge to support prudent decisions that provide the greatest potential to create value for both patients and our shareholders.

It is of course disappointing that we have decided to discontinue development of domatinostat, including all currently ongoing clinical studies. The preclinical data we generated for the candidate were very persuasive, but the clinical information now available, and which will be published in due course, indicates that domatinostat is unlikely to provide value to patients, physicians, or shareholders. We thank the investigators, the patients, and support staff who have participated in this important research program and will now focus our resources on resminostat and expect to reach an outcome for our pivotal study in CTCL as planned in 2023."

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]).

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

On February 2, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that it has completed the acquisition of Virex Health, Inc., a Boston, MA based company ("Virex"), spun out of the labs of Professors Mark Grinstaff and Scott Schaus at BU, on February 1, 2022 (Press release, Sorrento Therapeutics, FEB 1, 2022, View Source [SID1234607603]). The proprietary Virex Technology utilizes enzymatic and electrochemical amplification to detect picogram level biological analytes, such as SARS-CoV-2 and its variants, Flu A/B, as well as markers for liver cancer, inflammation and hormone monitoring.

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"One of the most exciting things about this Virex platform is the potential to finally provide an extremely sensitive and affordable detection test which is simple enough to use at home. Similar to a glucose meter, the amplified electrochemistry signal is converted to an electrical current and read in a reusable glucometer," said Dr. Scott Schaus, Co-Founder and Professor of Chemistry at BU. "Today there are glucose meters in nearly 1 in 10 households in the world. We know the chemistry is broadly adaptable and the supply chain highly scalable."

The Virex and Sorrento teams have been working together to define the first test with which to pursue commercialization. Key personnel, including Drs. Mark Grinstaff and Scott Schaus and Virex scientists, will assist with further development and commercialization.

"The current sensitivity for at-home testing is just too low, and the price per test is still too high for daily testing. With capabilities both in therapeutics and in diagnostics, Sorrento is an ideal company to take this next-generation Virex platform to the world across a wide range of analytes, including viruses, nucleic acids, proteins, hormones and other biomarkers," said Dr. Grinstaff, Co-Founder and a Distinguished Professor of Translational Research. Dr. Grinstaff is a Professor of Biomedical Engineering, Chemistry, Materials Sciences, Engineering and Medicine at BU. Dr. Grinstaff is an inventor of Abraxane and Adherus Surgical Sealants, and he has over 200 patents and patent applications to his name. "Virex seeks to leverage Sorrento’s extensive expertise in producing highly selective and specific monoclonal antibodies for use in at-home diagnostic tests, including tests capable of detecting SARS-CoV-2 nucleocapsid proteins and whole viruses."

"Sorrento has remarkable vision for impacting diagnostics and other sectors of healthcare," said Virex co-founder Keith Hearon, a former postdoctoral fellow in Professor Robert Langer’s Group at MIT. "Sorrento’s acquisition of Virex is particularly strategic because of Sorrento’s robust antibody library, which is highly complementary to Virex’s enzymatic amplification diagnostic assay platform. The puzzle pieces fit very nicely together."

"As Keith’s former postdoctoral advisor at MIT, I’ve continued to follow his career and I’m very proud of what a terrific entrepreneur he has become. He did a great job with his vision for Virex and found a wonderful home for it with Sorrento under the outstanding leadership of Henry Ji," said Professor Langer, David H. Koch Institute Professor at Massachusetts Institute of Technology.

"We at Sorrento are amazed by the unmatched sensitivity of the Virex tests for detecting the virus that causes COVID-19 and are excited to mass produce and commercialize the rapid at-home tests for daily COVID-19 testing and frequent early cancer detection," said Dr. Henry Ji, Chairman and CEO of Sorrento.

Virex received funding support in 2021 from the Massachusetts Life Sciences Center under its Accelerating Coronavirus Testing Solutions program.