On February 4, 2020 Nippon Kayaku reported Financial Results For the Third Quarter of the Fiscal Year Ending March 31, 2020 (Press release, Nippon Kayaku, FEB 4, 2020, View Source net/doc/4272/ir_material_for_fiscal_ym8/76321/00.pdf [SID1234553800]).

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1. Consolidated Business Results for the First Three Quarters of the Fiscal Year Ending March 31, 2020 (April 1, 2019–December 31, 2019)

(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: None
[2] Changes other than
[1]: None
[3] Changes to accounting estimates: None
[4] Restatements: None (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, 2019: 177,503,570 shares As of March 31, 2019: 182,503,570 shares
[2] Number of treasury stock at end of the fiscal period As of December 31, 2019: 5,275,358 shares As of March 31, 2019: 9,358,749 shares
[3] Average number of shares during the fiscal period (cumulative) First three quarters of fiscal year ending March 31, 2020: 173,012,317 shares First three quarters of fiscal year ended March 31, 2019: 173,145,466 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 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 Results Forecasts" on page 3 of the Supplementary Information

1. Qualitative Information Concerning Results for the First Three Quarters

(1) Analysis of Operating Results In the first three quarters of this consolidated fiscal year (April 1, 2019 to December 31, 2019), the global economy as a whole saw continued slow growth. This was mainly due to the deceleration of external demand in the manufacturing industry, while consumer spending remained steady on the back of an improved employment and income environment in the U.S. and Europe. The trend of deceleration in economic growth persisted in China, owing to the impact from trade friction between the U.S. and China, among other factors. The Japanese economy showed signs of a gradual rebound despite weak exports. This resulted mainly from moderate growth in capital investment and a resurgence in consumer spending. 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 this fiscal year.

We worked to cut costs further to reinforce our profit structure, in addition to focusing on strengthening R&D, optimal allocation of business resources into core businesses, and expanding our overseas business. Owing to these actions, net sales for the first three quarters of this consolidated fiscal year outperformed the same period of the previous fiscal year in the functional chemicals business, the pharmaceuticals business, and the safety systems business, resulting in total net sales of 131,825 million yen, an increase of 2,924 million yen (2.3%) yearon-year. Operating income totaled 14,231 million yen, a decrease of 331 million yen (2.3%) year-on-year. Ordinary income totaled 14,682 million yen, a decrease of 1,307 million yen (8.2%) year-on-year due to an increase in exchange losses. Profit attributable to owners of parent was 11,302 million yen, an increase of 721 million yen (6.8%) year-onyear due to a decrease in income taxes-deferred. Performance by business segment is as described below. [Functional Chemicals Business] Sales stood at 53,260 million yen, an increase of 1,892 million yen (3.7%) year-on-year. The functional materials business recorded growth in sales over the same period of the previous fiscal year. This growth was resulted from strong sales of epoxy resins for 5G base stations, which more than covered for the deceleration in demand from the semiconductor market. The color materials business outperformed the same period of the previous fiscal year, boosted by strong sales of colorants for inkjet printers for industrial applications and materials for thermal paper, despite the negative impact from deceleration of the Chinese market. The catalyst business outperformed the same period of the previous fiscal year. In the Polatechno Group, sales of components for X-ray analysis systems were strong, but sluggish sales of dyetype polarizing films resulted in underperformance of the Polatechno Group as a whole, compared with the same period of the previous fiscal year. Segment profit was 4,537 million yen, a decrease of 1,011 million yen (18.2%) year-on-year. [Pharmaceuticals Business] Sales stood at 36,327 million yen, an increase of 831 million yen (2.3%) year-on-year. Pharmaceuticals in Japan were impacted by drug price revisions accompanying the increase in the consumption tax rate, but the segment outperformed the same period of the previous fiscal year as growth in sales for the antibody biosimilar, INFLIXIMAB BS for I.V. Infusion, and for TRASTUZUMAB BS for I.V. Infusion contributed to performance along with growth in generic anti-cancer drugs as the switch to generic drugs continued. Although exports and diagnostic agents underperformed the same period of the previous fiscal year, sales of active pharmaceutical ingredients and contract production for the Japanese domestic market outperformed the same period of the previous fiscal year. Segment profit totaled 3,947 million yen, an increase of 991 million yen (33.5%) year-on-year. [Safety Systems Business] Sales stood at 36,182 million yen, an increase of 797 million yen (2.3%) year-on-year. Business in Japan outperformed the same period of the previous fiscal year due to firm sales of both airbag inflators and micro gas generators for seatbelt pretensioners. The overseas business overall saw sales decline from the same period of the previous year as the deceleration of Chinese market growth caused sales of air bag inflators and squibs to underperform year-on-year. While sales of micro gas generators for seatbelt pretensioners outperformed the same period of the previous fiscal year due to the increase in the automotive safety component installation rate, this did not compensate for the above decline. Nippon Kayaku Co., Ltd.

Summary of Consolidated Financial Results [Japanese GAAP] For the Third Quarter of the Fiscal Year Ending March 31, 2020

I. First three quarters of the fiscal year ended March 31, 2019 (April 1, 2018– December 31, 2018)

2. Information concerning impairment losses on non-current assets, goodwill, etc. by reportable segment (Material change in the amount of goodwill) The business combination with RaySpec Limited which was implemented on December 26, 2017, was subject to provisional accounting in fiscal year ended March 31, 2018 and confirmed during the previous consolidated fiscal year. This has resulted in a decrease in the amount of goodwill in the functional chemicals business segment. (Business Combinations, etc.) (Regarding the Acquisition of Shares via Tender Offer and the Demand for the Sale of Shares) Nippon Kayaku decided to acquire the consolidated subsidiary POLATECHNO CO., LTD. (hereafter, "Polatechno") via tender offer (hereafter, "this tender offer"), based on the Financial Instruments & Exchange Act. The resolution was approved at the Board of Directors meeting held on August 27, 2019.

This tender offer was executed and the acquisition was completed on October 10, 2019. A Demand for the Sale of Shares was subsequently exercised based on Article 179, Paragraph 1 of the Companies Act, and Nippon Kayaku made Polatechno a wholly owned subsidiary on November 12, 2019.

1. Summary of Business Combination (1) Name and business description of the business to be combined Name of company: POLATECHNO CO., LTD. Business description: Manufacture and sale of components for LCD displays, components for LCD projectors, etc.

(2) Dates of business combination Acquisition via tender offer: October 18, 2019 (deemed acquisition date: October 1, 2019) Acquisition via the Demand for the Sale of Shares: November 12, 2019 (deemed acquisition date: October 1, 2019)

(3) Legal form of business combination Acquisition of shares for cash

(4) Name of company after combination No change.

(5) Percentage of subsidiary shares held after additional acquisition: Percentage of shares held prior to business combination: 66.45% Percentage of shares held after tender offer: 99.20% Percentage of shares held after the Demand for the Sale of Shares: 100.00% 2.

Breakdown of the cost of acquiring additional shares of the subsidiary and type of payment (including the shares Nippon Kayaku intends to acquire via the Demand for the Sale of Shares) Acquisition for cash: 13,808 million yen Acquisition cost: 13,808 million yen 3.

Overview of Accounting Method Implemented These transactions qualify as transactions under common control specified in the Revised Accounting Standard for Business Combinations (ASBJ Statement No.21, September 13, 2013) and Revised Guidance on Accounting Standard for Business Combinations and Accounting Standard for Business Divestitures (ASBJ Guidance No.10, September 13, 2013) and Nippon Kayaku is handling these as transactions under common control.

On February 4, 2020 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "the Company" ) reported the status and the completion of acquisition of its own shares based on the resolution of the Board of Directors’ meeting held on October 31, 2019, pursuant to the Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act (Press release, Astellas, FEB 4, 2020, View Source [SID1234553798]).

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The Company also announced the number of shares to be canceled on February 14, 2020 pursuant to Article 178 of the Companies Act has been finalized.

Particulars

1. Status of acquisition of own shares
(1) Class of shares acquired: Common stock of the Company
(2) Total number of shares acquired: 7,009,900 shares
(3) Total amount of acquisition cost: 13,133,509,050 yen
(4) Period of acquisition: From January 1, 2020 to January 31, 2020
(5) Method of acquisition: Purchased on the Tokyo Stock Exchange

2. Details of the cancellation of treasury stock
(1) Class of shares to be cancelled: Common stock of the Company
(2) Number of shares to be cancelled: 27,036,100 shares
(Ratio to the total number of shares outstanding [excluding treasury stock]:
1.45 %)
(3) Cancellation date: February 14, 2020

2
(Reference)
1. Details of the resolution at the meeting of the Board of Directors on October 31,
2019

(1) Class of shares to be acquired: Common stock of the Company
(2) Total number of shares to be acquired: Up to 32 million shares
(Ratio to the total number of shares outstanding [excluding treasury stock):
1.70%]
(3) Total amount of acquisition cost: Up to 50 billion yen

(4) Period of acquisition: From November 1, 2019 to January 31, 2020
2. Accumulated Company’s own shares acquired pursuant to the above board resolution
(1) Total number of shares acquired: 27,036,100 shares
(2) Total amount of acquisition cost: 49,999,815,550 yen
(Ratio to the total number of shares outstanding [excluding treasury stock]:
1.45 %)

3. Details of the decided cancellation of treasury stock (October 31, 2019)

(1) Class of shares to be cancelled: Common stock of the Company
(2) Total number of shares to be cancelled: All of the shares repurchased
as stated in 2 above
(3) Scheduled cancellation date: February 14, 2020

4. Status of shares after cancellation
(1) Number of shares issued: 1,861,787,075 shares (expected)
(2) Number of the Company’s treasury stock: 3,381,929shares (expected)
[Estimated numbers of shares described above (1) and (2) were calculated on the basis of the issued shares and the Company’s treasury stock as of January 31, 2020, respectively.]

On February 4, 2020 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that it has reached its patient enrollment target in the Company’s Phase 2 clinical trial for glioblastoma (Press release, AIVITA Biomedical, FEB 4, 2020, View Source [SID1234553797]). The trial has achieved its enrollment target ahead of schedule and under budget, with a notable 94% treatment manufacturing success rate.

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AIVITA’s eight-site, single-arm study is investigating AV-GBM-1, a novel immunotherapy targeting autologous tumor-initiating cells that are responsible for the rapid growth and proliferation of the disease.

The highly sophisticated immunotherapy product requires short term cell culture and a successful leukapheresis in order to generate the final treatment product. AIVITA achieved a 97% success rate growing tumor-initiating cells from each patient, and 97% success rate in collecting sufficient monocytes from the peripheral blood from which to derive dendritic cells, resulting in a 94% overall success rate for manufacturing a final product.

"An extremely high manufacturing success rate combined with a very low cost of goods makes this approach highly desirable from both a clinical and commercial viability perspective," said Bob Dillman, M.D., Chief Medical Officer of AIVITA. "We’re already exploring new ways to further increase efficiency and expand the applicability of this approach."

AIVITA is investigating the clinical efficacy of its immunotherapy alone and in combination with PD-1 inhibitors, having determined that a significant portion of unresponsive subjects from a previous trial had elevated PD-1 levels. The Company is also exploring ways in which the technology could be deployed as a maintenance treatment, recognizing that cancer recurrence may come from dormant cancer cells that go undetected by conventional treatments.

"I want to thank the investigators and clinical sites who have done such an excellent job of managing patient care for the trial and helped us reach this important milestone," said Hans S. Keirstead, Ph.D., Chairman and Chief Executive Officer of AIVITA. "These successes are certainly challenging prior expectations of personalized medicine."

AIVITA is currently conducting three distinct clinical studies in the USA investigating its platform immunotherapy, in patients with ovarian cancer, glioblastoma and melanoma. AIVITA is also seeking conditional commercial approval of its melanoma treatment in Japan.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

On February 3, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that President and CEO Athena Countouriotis, M.D., will participate in a question and answer session at the Guggenheim Healthcare Talks Oncology Day in New York on Feb. 13 (Press release, Turning Point Therapeutics, FEB 3, 2020, View Source [SID1234564380]).

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Dr. Countouriotis’ session is scheduled to begin at 10 a.m. ET and will be accessible via audio webcast through the Investors page of www.tptherapeutics.com.

On February 3, 2020 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported the closing of its previously announced sale of a number of its bioengineering assets and the related sale of $35 million of its common stock to an affiliate of Third Security LLC (Press release, Intrexon, FEB 3, 2020, View Source [SID1234553806]). Additionally, effective February 1, 2020, the Company has changed its name to Precigen, Inc. from Intrexon Corporation and its Nasdaq stock symbol to PGEN from XON. The new Precigen enters 2020 with a promising portfolio of investigational gene and cell therapies, derived from the Company’s transformative therapeutic platforms, including UltraCAR-T, AdenoVerse cytokine therapies, multifunctional therapeutics and off-the-shelf AdenoVerse immunotherapies, as well as innovative approaches from our subsidiaries ActoBio Therapeutics, Exemplar Genetics, and Triple-Gene.

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"With multiple data read-outs on track for our internal pipeline and partnered programs, we believe 2020 will be an exciting year for Precigen," said Helen Sabzevari, Ph.D., President and CEO of Precigen. "At the same time, we plan to further optimize our portfolio this year through a renewed commitment to financial rigor and fiscal discipline."

"We are particularly enthusiastic about the opportunity to advance our UltraCAR-T platform as current CAR-T treatments rely on a long, complex, and relatively inefficient manufacturing process that delays treatment for cancer patients and leads to high pricing. By contrast, UltraCAR-T is designed to overcome many of these obstacles by eliminating the need for ex vivo expansion, reducing overall manufacturing time, and enabling patients to be treated with CAR-T therapy only one day after non-viral gene transfer at the cancer center. UltraCAR-T has the potential to democratize patient care by simplifying this life-saving cancer immunotherapy which should improve availability throughout the world," added Dr. Sabzevari.

Two non-healthcare businesses remain with Precigen and the Company will continue to evaluate strategic and operational options for these businesses.

Dr. Sabzevari presented an overview of Precigen at the 38th Annual J.P. Morgan Healthcare Conference on January 14, 2020, and a replay of the presentation is available on Precigen’s website in the Events section at View Source