On July 30, 2021 Minovia Therapeutics, Ltd. (CEO; Natalie Yivgi-Ohana, Ph.D., "Minovia") and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) reported a worldwide strategic collaboration and license agreement for the research, development, and commercialization of novel cell therapy programs for diseases caused by mitochondrial dysfunction (Press release, Astellas, JUL 30, 2021, View Source [SID1234585455]).

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Through this strategic collaboration, Astellas and Minovia aim to accelerate the creation of allogeneic mitochondrial cell therapy programs. The two companies will jointly research cell therapy program candidates comprised of cells derived from Astellas’ proprietary genetically-engineered, induced pluripotent stem cells and augmented with Minovia’s proprietary MAT platform technology. The goal of these programs will be to treat diseases caused by mitochondrial dysfunction, through the transfer of healthy mitochondria to restore the patients’ tissues.

Minovia is a leading company in the field of mitochondrial cell therapy that utilizes mitochondrial transfer to deliver healthy mitochondria to a patient’s diseased cells. Minovia has a unique technology platform called Mitochondrial Augmentation Therapy (MAT), where the patient’s own cells are isolated, loaded with healthy mitochondria obtained from a healthy donor, and then re-infused back into the patient. Minovia is currently conducting research, development and clinical studies with MAT in mitochondrial diseases.

Astellas is engaged through its US subsidiary companies, Astellas Institute for Regenerative Medicine (AIRM) and Universal Cells Inc., to advance allogeneic, off-the-shelf, differentiated cell therapy programs derived from pluripotent stem cells1. The new collaboration with Minovia extends Astellas’ capabilities in mitochondrial biology, and follow its recent acquisition of Mitobridge, Inc. and Nanna Therapeutics Limited2,3.

"We are excited and honored to collaborate with Astellas," stated Minovia’s Co-founder and Chief Executive Officer, Natalie Yivgi-Ohana, Ph.D. "We share with Astellas both their passion for mitochondrial science and their commitment to patients in need of new therapies. As Minovia continues the development of Mitochondrial Augmentation Therapy, we believe this partnership is critical to accelerate the development of off-the-shelf, allogeneic cell therapy programs for the many patients living with mitochondrial diseases caused by mitochondrial dysfunction."

Naoki Okamura, Representative Director, Corporate Executive Vice President, Chief Strategy Officer and Chief Financial Officer, at Astellas said, "We, at Astellas, have positioned mitochondrial biology as one of the Primary Focuses of our research and development strategy to develop therapies for patients with unmet medical needs. One of the aspirations of this Primary Focus is to establish a mitochondrial cell therapy platform. Minovia is pioneering mitochondrial cell therapy and has unique technologies for enhancing delivery of healthy mitochondria to the patients’ cells. This strategic collaboration with Minovia will accelerate and expand our pipeline of treatment options for patients with diseases with underlying mitochodrial dysfunction."

Under the terms of the agreement, Minovia receives an upfront cash payment of $20M USD. Through the joint research program with Minovia, if Astellas develops and commercializes product candidates for diseases caused by mitochondrial dysfunction, Minovia is eligible to receive up to $420M USD per product in future development, regulatory and commercial milestone payments from Astellas.

On July 30, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for the first three months (April 1, 2021 – June 30, 2021) of the fiscal year 2021 (FY2021) ending March 31, 2022 (Press release, Astellas, JUL 30, 2021, View Source [SID1234585456]).

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1. Qualitative information on consolidated financial results for the first three months of FY2021 (1) Business performance Consolidated financial results (core basis) in the first three months of FY2021 are shown in the table below. While revenue increased, core operating profit and core profit decreased.

Revenue-Sales of XTANDI for the treatment of prostate cancer and Strategic products XOSPATA for the treatment of acute myeloid leukemia, PADCEV for the treatment of urothelial cancer and Evrenzo for the treatment of renal anemia increased as expected.

-Moreover, factors for the increase in sales in the first three months of FY2021 included the growth of sales of Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB"), and the sales of pharmacologic stress agent Lexiscan returning to pre-pandemic level which decreased mainly in the corresponding period of the previous fiscal year because of 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 promotion activities for Celecox for the treatment of inflammation and pain, the transfer of manufacturing rights of 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 three months of FY2021 increased by 6.2% compared to those in the corresponding period of the previous fiscal year ("year-on-year") to ¥326.1 billion. Core operating profit/ Core profit-Gross profit increased by 6.7% year-on-year to ¥263.9 billion. The cost-to-revenue ratio fell by 0.4 percentage points year-on-year to 19.1%, mainly due to changes in product mix.-Selling, general and administrative expenses increased by 13.5% year-on-year to ¥137.1 billion.

The total amount increased due to the up-front investment to support CSP2021 initiatives (increase of Approx. ¥3.0 billion year-on-year), the increase of co-promotion fees associated with the growth of sales of XTANDI in the United States (increase of ¥3.0 billion year-on-year), the impact of the exchange rate (increase of ¥4.4 billion year-on-year), and moreover there was a one-off increase factor from the decrease of expenses for sales promotion activities and travel expenses due to the impact of the spread of COVID-19 in the corresponding period of the previous fiscal year (increase of Approx. ¥6.0 billion year-on-year). Excluding co-promotion fees associated with the growth of sales of XTANDI in the United States, selling, general and administrative expenses increased by 15.0% year-on-year to ¥102.6 billion.

-Research and development (R&D) expenses increased by 1.8% year-on-year to ¥58.3 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 3 Primary Focus, such as genetic regulation, cell therapy and immuno-oncology.-Amortisation of intangible assets increased by 1.8% year-on-year to ¥6.0 billion.

As a result of the above, core operating profit decreased by 0.9% year-on-year to ¥62.8 billion, and core profit decreased by 5.3% year-on-year to ¥49.2 billion. Impact of exchange rate on financial results The exchange rates for the yen in the first three months of FY2021 are shown in the table below. The resulting impacts were a ¥13.6 billion increase in revenue and a ¥6.1 billion increase in core operating profit compared with if the exchange rates of the first three months of FY2020 were applied.

On July 30, 2021 Nippon Kayaku reported that (Press release, Nippon Kayaku, JUL 30, 2021, View Source [SID1234585676])

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1. Consolidated Business Results for the First Quarter of Fiscal Year Ending March 31, 2022 (April 1, 2021– June 30, 2021) (Figures shown are rounded down to the nearest million yen.)

(1) Consolidated Operating Results(2) Consolidated Financial Position

2. Status of Dividends

3. Consolidated Business Results Forecasts for the Fiscal Year Ending March 31, 2022 (April 1, 2021– March 31, 2022)1. Qualitative Information Concerning Results for the First Quarter

(1) Analysis of Operating Results During the first quarter of this consolidated fiscal year (April 1 to June 30, 2021), the global economy saw economic activity begin to return to normal and signs of economic recovery, due in part to progress on vaccinations for the novel coronavirus (COVID-19). While the Japanese economy continues to experience a slump in consumer spending and other domestic demand relative to Europe and the U.S., business sentiment has improved due to growth in demand accompanying the rebound in overseas economies.

However, a sense of uncertainty remains due to concerns about the resurgence of COVID-19 and deterioration in profitability from the steep rise in raw material prices. The semiconductor shortage has also impacted the automotive industry domestically and overseas. Amid these conditions, the Nippon Kayaku Group worked to implement the key themes and resolve the midand long-term key issues outlined in "KAYAKU Next Stage," the mid-term business plan launched in the fiscal year ended March 31, 2020, while also making active use of flextime, telecommuting, and other systems to accommodate the partial restrictions on corporate activity. We took these steps to ensure the safety of employees working in the Company and at Group companies while also implementing a new lifestyle and promote efficient workstyles aimed at minimizing the impact on our business. As a result, net sales for the first quarter of this consolidated fiscal year totaled 46,447 million yen, an increase of 9,622 million yen (26.1%) year-on-year.

Sales in the functional chemicals, the pharmaceuticals, the safety systems, and other businesses outperformed the first quarter of the previous fiscal year in all segments. Operating income totaled 5,938 million yen, an increase of 3,164 million yen (114.1%) year-on-year. Ordinary income totaled 6,399 million yen, an increase of 3,414 million yen (114.4%) year-on-year. Profit attributable to owners of parent was 5,295 million yen, an increase of 3,546 million yen (202.9%) year-on-year. Regarding changes in accounting policies, the Company implemented the Accounting Standard for Revenue Recognition (ASBJ Statement No. 29, revised March 31, 2020) and other guidance from the beginning of the first quarter of this consolidated fiscal year.

We have therefore used numbers based on calculation methods subject to different standards than in the same period of the previous fiscal year. See 2. Quarterly Consolidated Financial Statements and Notes to Quarterly Consolidated Financial Statements, (3) Notes to Quarterly Consolidated Financial Statements (Changes to Accounting Policies) for further details. Performance by business segment is as described below. [Functional Chemicals Business] Sales stood at 20,089 million yen, an increase of 4,256 million yen (26.9%) year-on-year. The functional materials business as a whole outperformed the first quarter of the previous fiscal year.

The outperformance resulted from strong sales of epoxy resins used in semiconductor encapsulation, circuit boards, and LCD cleaners from increased demand for IT equipment due to teleworking, in addition to the proliferation of high-speed (5G) communications devices and IoT, and the increasingly sophisticated electronic equipment in vehicles. The color materials business as a whole outperformed the first quarter of the previous fiscal year. This outperformance was due to a rebound in demand for colorants for inkjet printers in industrial applications and developer for thermal paper, in addition to strong sales of colorants for inkjet printers for consumer use. The catalyst business outperformed the first quarter of the previous fiscal year, both in Japan and exports overseas. In the Polatechno business, a rebound in demand for polarizing films for LCD projectors and dye-type polarizing films, in addition to strong sales of components for X-ray analysis systems resulted in outperformance of the Polatechno business as a whole, compared with the first quarter of the previous fiscal year. Segment profit totaled 3,449 million yen, an increase of 1,945 million yen (129.3%) year-on-year.

This increase resulted from growth in net sales in each business. [Pharmaceuticals Business] Sales stood at 12,773 million yen, an increase of 82 million yen (0.6%) year-on-year. Pharmaceuticals in Japan underperformed the first quarter of the previous fiscal year due to the impact from drug price revisions, despite market penetration of Portrazza, a biomedicine; the switch to antibody biosimilars, TRASTUZUMAB BS and INFLIXIMAB BS; and growth in sales of a cancer-related generic, APREPITANT capsule. Exports and sales of active pharmaceutical ingredients for the Japanese domestic market underperformed while sales of contract production and diagnostic drugs outperformed the same period of the previous fiscal year.

Segment profit totaled 1,925 million yen, a decrease of 225 million yen (10.5%) year-on-year. This resulted from the impact of drug price revisions, in addition to increased expenses related to sales activities adjusted to the new life style and progress on R&D activities. Nippon Kayaku Co., Ltd. Summary of Consolidated Financial Results [Japanese GAAP] For the First Quarter of the Fiscal Year Ending March 31, 2022 This document is an English translation of the Japanese-language original. All financial information has been prepared in accordance with generally accepted accounting principles in Japan.-3-[Safety Systems Business] Sales reached 11,382 million yen, an increase of 5,081 million yen (80.6%) year-on-year. During the first quarter of this consolidated fiscal year, the automobile market continued to rebound from the slump in global demand caused by the global spread of the novel coronavirus, with the exception of a few regions.

While decrease in the pace of automobile production was seen from the latter half of the period owing to the impact of the semiconductor shortage, sales of airbag inflators, micro gas generators for seatbelt pretensioners, and squibs outperformed the first quarter of the previous fiscal year in both the domestic and overseas businesses, due to strong demand for the period. The increase in sales led to segment profit of 1,799 million yen, an increase of 1,536 million yen (584.2%) from the same period of the previous fiscal year. [Other] Sales stood at 2,202 million yen, an increase of 202 million yen (10.1%) year-on-year. The agrochemicals business overall saw a year-on-year increase in domestic sales and exports. Sales in real estate and other business increased compared to the same period of the previous fiscal year. Segment profit totaled 444 million yen, a decrease of 62 million yen (12.4%) year-on-year. (2) Analysis of Financial Position Total assets were 297,619 million yen, an increase of 3,084 million yen from the end of the previous consolidated fiscal year.

The main increases were in raw materials and stores, an increase of 3,087 million yen; goodwill, an increase of 1,305 million yen; and securities, an increase of 1,241 million yen. The main decreases were in notes and accounts receivable-trade, a decrease of 1,167 million yen; and investment securities, a decrease of 1,021 million yen. Liabilities were 66,807 million yen, an increase of 545 million yen compared to the end of the previous consolidated fiscal year. The main increase was in notes and accounts payable-trade, an increase of 1,121 million yen.

The main decrease was in accounts payable-other, a decrease of 1,165 million yen. Net assets were 230,812 million yen, an increase of 2,538 million yen compared to the end of the previous consolidated fiscal year. The main increases were in retained earnings, an increase of 2,745 million yen; and translation adjustments, an increase of 1,465 million yen. (3) Analysis of Forward-looking Statements, Including Consolidated Business Forecasts The future business environment surrounding the Nippon Kayaku Group is expected to bring further economic rebound as economic activities in Japan and overseas return to normal, owing to progress on vaccination for the novel coronavirus. However, uncertainty over the impact of a change in interest rate policies in different countries and U.S.-China trade friction poses the risk of an economic downswing.

Under these conditions, the Nippon Kayaku Group aims to respond flexibly to changes in the business environment and pursue optimal use of operating capital to increase the shareholder value, as well as expand existing businesses in global growth markets, accelerate the development of new businesses and new products, and enhance profits. Consolidated business results forecasts for the first half and full year consolidated business results forecasts of fiscal year ending March 31, 2022 announced on May 11, 2021 have been revised. See the disclosure today entitled, Notice Concerning Revision of Consolidated Business Results Forecasts for the Fiscal Year Ending March 31, 2022 for further details.

On July 30, 2021 XBiotech Inc. (NASDAQ: XBIT) ("XBiotech") reported that it has completed payment to holders of its Common Stock of a previously announced dividend in the amount of USD$75,000,000.00. Based on the number of shares of Common Stock issued and outstanding on the record date for the dividend, each such holder received USD$2.47 per share on July 23, 2021 (Press release, XBiotech, JUL 30, 2021, View Source [SID1234585457]).

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In the past 18 months, XBiotech’s balance sheet strength has enabled the company to offer approximately USD$495 million in cash to shareholders by way of stock repurchase and dividend distribution. The financial strength of the Company owes to the successful development of a pipeline of True Human antibody drug candidates.

John Simard stated that "XBiotech was pleased to be able to reward its shareholders with a $2.47 per share dividend. Our ability to continue to provide opportunities for shareholders to monetize stock in XBiotech, reflects the strength of our fundamental approach to our industry. It begins with a visionary strategy to create a drug pipeline from natural human immunity—which offers an array of exceptional candidate therapeutics. Proprietary manufacturing technology developed at XBiotech has reduced our capital outlays needed for producing drug product, enabling us to build a drug development infrastructure debt-free. Integrating clinical operations has allowed us to conduct our own clinical trials, to test our breakthrough therapies, for a fraction of the cost of the standard industry approach, which involves the use of expensive clinical research contractors. Finally, from our manufacturing technology and clinical operations, we have generated contract revenue that has largely offset operating costs over the past two years. In short, we have stayed the course with our science and pushed the boundaries of industry practices to develop breakthrough therapies, reduce costs and create returns for our shareholders. We have never been more excited about our pipeline and opportunities than we are today."

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

On July 30, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported the publication of a comprehensive preclinical in vitro and in vivo data package of its innate cell engager (ICE) AFM24 (CD16A/EGFR) in mAbs (Press release, Affimed, JUL 30, 2021, View Source [SID1234585476]). The published data were the basis for the Investigational New Drug (IND) clearance for Affimed’s ongoing Phase 1/2a study with AFM24 monotherapy in patients with EGFR expressing solid tumors. The preclinical data demonstrates AFM24’s unique mechanism of action that harnesses the innate immune system to induce tumor cell killing via antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell phagocytosis (ADCP).

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"These pre-clinical data are encouraging as they demonstrate the potential for AFM24 to effectively target a broad set of tumors expressing varying levels of EGFR, regardless of their mutational status, and with the potential for less pronounced EGFR-related toxicities than current treatment options," said Arndt Schottelius, M.D., Ph.D., Chief Scientific Officer at Affimed. "This could be highly relevant for many patients with different tumor types despite existing EFGR-targeting therapies as these have limitations in efficacy and safety."

Highlights of the recently published results include:

AFM24 binds with high affinity to CD16A on NK cells and macrophages in vitro.
AFM24 potently induces ADCC via NK cells, and ADCP via macrophages in vitro.
AFM24 is effective against many EGFR-positive tumor cells, regardless of EGFR expression level and KRAS/BRAF mutational status within in vitro studies.
AFM24 is well tolerated up to the highest dose level (75 mg/kg) with no skin and other toxicities in cynomolgus monkeys.
The full manuscript is available here: https://bit.ly/3zLDq3i

About AFM24
AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

Affimed is evaluating AFM24 as a monotherapy for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24-101 is a first-in-human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study and can be found at www.clinicaltrials.gov using the identifier NCT04259450. In addition, Affimed is planning to initiate further studies evaluating AFM24 in combination with Roche’s atezolizumab, an anti-PD-L1 checkpoint inhibitor and, separately, an investigation of AFM24 in combination with NKGen Biotech’s autologous NK cell product.