Business Results for the Third Quarter of the Fiscal Year Ending December 31, 2020 (Unaudited)

On November 11, 2020 Kuraray reported that (Press release, Kuraray, NOV 11,2020,https://pdf.irpocket.com/C3405/aMKh/VVRN/bW0m.pdf [SID1234570579])

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Consolidated Earnings Report for the Third Quarter of the Fiscal Year Ending December 31, 2020

Name of listed company: Kuraray Co., Ltd.
Stock code: 3405 Stock exchange listing: Tokyo, first section
URL: View Source Representative:
Title: Representative Director and President Name: Masaaki Ito Contact: Title: Senior Manager, Corporate Communications Department, Corporate Management Planning Office Name: Fumio Uegaki Tel: +81-3-6701-1070 Preparation of supplementary documentation for the quarterly earnings report: Yes Holding of quarterly earnings results briefing: Yes (for securities analysts and institutional investors) (Millions of yen rounded down unless otherwise stated)

1. Consolidated Financial Results for the Third Quarter of the Fiscal Year Ending December 31, 2020 (January 1, 2020 to September 30, 2020)

(1) Consolidated Operating Results (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)

(2) Consolidated Financial Position2. Dividends3. Forecasts of Consolidated Financial Results for the Fiscal Year Ending December 31, 2020 (January 1, 2020 to December 31, 2020) (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)

[Reference]
(1) Changes in Important Subsidiaries during the Period (Changes in Special Subsidiaries Involving Changes in the Scope of Consolidation) Added: No companies Excluded: No companies
(2) Adoption of Special Accounting Practices in the Preparation of Quarterly Consolidated Financial Statements No
(3) Changes in Accounting Principles, Procedures and Presentation Methods in Connection with the Preparation of

Quarterly Consolidated Financial Statements

1. Changes following revision of accounting standards:
No 2. Changes besides 1. above:
No 3. Changes in accounting estimates:
No 4. Restatement:
No (4) Number of Shares Issued and Outstanding (Common Shares)

1. Number of shares issued and outstanding (including treasury stock) as of the period-end: As of September 30, 2020 354,863,603 shares As of December 31, 2019 354,863,603 shares 2. Number of treasury shares as of the period-end:

As of September 30, 2020 10,939,561 shares As of December 31, 2019 11,130,834 shares 3. Average number of shares for the period (cumulative): As of September 30, 2020 343,865,009 shares As of September 30, 2019 346,518,211 shares Note: It is not required that this type of earnings report be audited. Cautionary Statement with Respect to Forecasts of Consolidated Business Results (Cautionary note regarding forward-looking statements)

The results forecasts presented in this document are based upon currently available information and assumptions deemed rational. A variety of factors could cause actual results to differ materially from forecasts. Please refer to "(3) Basis for the Revision in Forecasts, Including Consolidated Operating Results Forecasts" on page 4 of the Attachment for the assumptions used.

1. Qualitative Information regarding Business Results

(1) Overview of Consolidated Business Results In the third quarter of fiscal 2020 (January 1, 2020–September 30, 2020), despite a decline in demand in many industries as the spread of COVID-19 continued to grow, economic activities began to gradually restart later on, and China and the United States saw signs of recovery. Even amid this kind of environment, our Group maintained its business activities while thoroughly ensuring safety and working to prevent infection with the aim of supporting industrial supply chains. Consequently, consolidated operating results for the third quarter of fiscal 2020 are as follows: net sales fell ¥35,136 million, or 8.2%, compared with the previous fiscal year to ¥393,778 million; operating income decreased ¥9,807 million, or 23.2%, to ¥32,527 million; ordinary income decreased ¥8,118 million, or 21.4%, to ¥29,823 million; and net income attributable to owners of the parent fell ¥4,210 million, or 21.8%, to ¥15,147 million. The Group’s long-term vision, Kuraray Vision 2026, is to become a "Specialty Chemical Company, growing sustainably by incorporating new foundational platforms into its own technologies."

As we continue working to realize this vision, we will steadily take specific measures in line with the key management strategies underlined in the medium-term management plan "PROUD 2020" from a medium-to long-term perspective. Through these efforts, we will also continue working to establish a new business portfolio. Results by Business Segment Vinyl Acetate Sales in this segment decreased 7.3% year on year to ¥186,759 million, and segment income fell 22.3% year on year to ¥27,996 million.

(1) Sales of PVA resin remained weak due to stagnant global demand and a subsequent production adjustment. Due to a recovery in demand, especially for large displays, sales of optical-use poval film remained firm. Sales of PVB film were affected by stagnant demand for construction and automotive applications. However, sales of water-soluble PVA film continued to expand for use in unit dose detergent packets.

(2) The sales volume of EVAL ethylene vinyl alcohol copolymer (EVOH resin) increased for food packaging applications due to expanded at-home consumption but the sales volume for gas tank applications fell due to a decline in the number of vehicles produced. Isoprene Sales in this segment decreased 9.6% year on year to ¥36,143 million, and segment income fell 48.1% year on year to ¥2,130 million.

(1) Sales of isoprene chemicals and SEPTON thermoplastic elastomer were affected by stagnant demand, mainly in China and the rest of Asia.

(2) Although sales of GENESTAR heat-resistant polyamide resin remained steady for electric and electronic device applications, sales for automotive applications were affected by the decline in automobile production. Functional Materials Sales in this segment decreased 4.1% year on year to ¥90,675 million, and segment income fell 9.4% year on year to ¥2,891 million.

(1) The overall methacrylate business was affected by rising raw material costs and worsening market conditions despite an increase in sales of spatter-blocking barrier panels and displays.

(2) In the medical business, although the dental materials business struggled early on in Europe and the United States as a result of an increase in the number of closed dental clinics due to the pandemic, demand is on track toward a recovery as clinics later reopened.

(3) As for Calgon Carbon, sales were steady even during the novel coronavirus crisis as this business’s products underpin people’s daily lives. In the Carbon Materials business, sales increased due to growing demand for water treatment applications. Furthermore, in line with expanding demand for high-performance activated carbon, we decided to expand facilities at Calgon Carbon Corporation’s existing U.S. factory in the second quarter. In addition, with expanding demand for industrial applications, we decided in this third quarter to expand the facilities for reactivated carbon at our Belgian subsidiary.

Fibers and Textiles Sales in this segment fell 15.9% year on year to ¥40,020 million while segment income decreased 38.0% year on year to ¥2,703 million.

(1) The sales volume of CLARINO man-made leather decreased due to receding demand in Asia and Europe.

(2) In fibers and industrial materials, demand for KURALON stagnated. The sales volume decreased for cement reinforcement and rubber materials.

(3) In consumer goods and materials, sales of KURAFLEX were weak as demand for cosmetic and automotive applications stagnated despite an increase in sales for mask-related applications. Trading Although sales of products for various applications struggled in fiber-related businesses, demand for resins and chemicals recovered in China, and performance was on par with the previous year.

As a result, segment sales decreased 7.7% year on year to ¥89,322 million, and segment income fell 6.1% to ¥2,817 million. Others In other business, due to weak sales of domestic affiliates, segment sales declined 16.3% year on year to ¥32,051 million, and segment income fell 40.4% to ¥347 million.

(2) Overview of Financial Position We increased liquidity in preparation of the novel coronavirus pandemic. Specifically, liquidity comprising cash and cash deposits and short-term investment securities increased ¥103,670 million due mainly to an increase of ¥135,996 million in interest-bearing debt, including increases of ¥30,000 million in corporate bonds, ¥28,000 million in commercial paper, ¥78,364 million in long-term loans payable. In addition to the above, accrued expenses decreased ¥25,927 million, and, as a result total assets increased ¥83,898 million from the end of the previous fiscal year to ¥1,075,047 million,) and total liabilities increased ¥94,353 million to ¥546,957 million.

Total net assets fell ¥10,455 million to ¥528,089 million. Equity attributable to owners of the parent amounted to ¥512,924 million, for an equity ratio of 47.7%

(3) Basis for the Revision in Forecasts, Including Consolidated Operating Results Forecasts Although the COVID-19 is continuing to spread, we saw signs of recovery in demand for the Company’s mainstay applications, including automobiles, electronic devices, and displays, especially in China and the United States, underpinned by economic stimulus measures. Demand is expected to continue gradually recovering while countries work to control the pandemic and maintain social and economic activities. We have revised the full-year operating results forecast announced in August 12, 2020 based on the consolidated third quarter operating results, the current business environment, and trends in exchange rates and raw material prices. Revised Consolidated Operating Results Forecast for Fiscal 20202.

Quarterly Consolidated Financial Statements and Notes

(1) Quarterly Consolidated Balance Sheets
(2) Quarterly Consolidated Statements of Income and Quarterly Consolidated Statements of Comprehensive Income Quarterly Consolidated Statements of Income1. The "Other Business" category incorporates operations not included in business segment reporting, including the environmental business and engineering business.

2. Adjustment is as follows: Included within segment loss of ¥8,947 million is the elimination of intersegment transactions ended as a profit of ¥1,622 million and corporate expenses ended as a loss of ¥10,570 million. Corporate expenses mainly comprise the submitting company’s basic research expenses.

3. Segment income is adjusted to agree with operating income in the consolidated statements of income.

2. Information related to goodwill or impairment loss of fixed assets for each reportable segment

Important impairment losses related to fixed assets In the vinyl acetate segment, Kuraray recorded an impairment loss. Furthermore, the amount recorded for said impairment loss was ¥3,358 million in the third quarter of the fiscal year.II. Third Quarter of Fiscal 2020 (January 1, 2020 to September 30, 2020)

1. Net sales, income and loss by reporting segment1. The "Other Business" category incorporates operations not included in business segment reporting, including the environmental business and engineering business.

2. Adjustment is as follows: Included within segment loss of ¥6,358 million is the elimination of intersegment transactions ended as a profit of ¥1,448 million and corporate expenses of ended as a loss ¥7,807 million. Corporate expenses mainly comprise the submitting company’s basic research expenses. 3. Segment income is adjusted to agree with operating income in the consolidated statements of income.

Syndax Announces Presentation at Stifel 2020 Virtual Healthcare Conference

On November 11, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Briggs W. Morrison, M.D., Chief Executive Officer of Syndax, will present at the Stifel 2020 Virtual Healthcare Conference on Wednesday, November 18, 2020 at 1:20 p.m. ET (Press release, Syndax, NOV 11, 2020, View Source [SID1234570572]).

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A live webcast of the presentation can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

Surface Oncology Announces FDA Fast Track Designation Granted by U.S. Food and Drug Administration for SRF388 to Treat Liver Cancer

On November 11, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SRF388 for the treatment of patients with hepatocellular carcinoma (HCC), or liver cancer, who have been previously treated with standard therapies, such as vascular endothelial growth factor targeted agents and programmed death-ligand (PD-L1) blockade (Press release, Surface Oncology, NOV 11, 2020, View Source [SID1234570571]).

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"Liver cancer is the most rapidly increasing type of cancer in both men and women in the U.S., with incidences tripling since 1980.1 2 There is a significant need to expedite the development of new therapies to treat liver cancer as the five-year survival for patients with unresectable or metastatic liver cancer is less than five percent,"2 said Rob Ross, M.D., chief medical officer. "SRF388 targets IL-27, an immuno-suppressive cytokine that has been found to be elevated in patients with liver cancer, as well as kidney cancer, and we believe SRF388 has the potential to be an effective treatment option for these patients, as monotherapy or in combination with anti-PD-1 therapies."

SRF388 is currently enrolling patients with advanced solid tumors in a Phase 1 monotherapy dose escalation study with planned expansions in liver and kidney cancer to further evaluate SRF388 as a monotherapy and in combination with other cancer therapies.

The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs that are being developed to treat serious conditions and fill an unmet medical need. The purpose of the designation is to bring important new drugs to patients earlier across a wide range of diseases.

SRF388 recently received orphan-drug designation for treatment of hepatocellular carcinoma from the FDA.

About SRF388:

SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immuno-suppressive cytokine. Surface Oncology has identified particular tumor types, including liver and kidney cancer, where IL-27 appears to play an important role in the immuno-suppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. SRF388 targets the rate-limiting p28 subunit of IL-27, and preclinical studies have shown that treatment with SRF388 blocks the immuno-suppressive biologic effects of IL-27, resulting in immune cell activation in combination with other cancer therapies and potent anti-tumor effects as a monotherapy. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping identify patients most likely to respond to SRF388.

ProMIS Neurosciences Announces Third Quarter 2020 Results

On November 11, 2020 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) ("ProMIS or the Company"), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three and nine months ended September 30, 2020 (Press release, ProMIS Neurosciences, NOV 11, 2020, View Source [SID1234570570]).

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"Over the course of the third quarter of 2020, the value of our unique discovery and development platform was further evidenced as ProMIS made considerable progress in expanding its portfolio of opportunities across multiple neurodegenerative diseases and also initiated two new diagnostic

joint venture programs with BC Neuroimmunology Laboratory (BCNI)," stated Eugene Williams, ProMIS’ Executive Chairman. "We look forward to continued progress applying our unique technology platform to the development of disease-modifying antibody therapies, diagnostics and potential vaccines for Alzheimer’s disease, as well as development in the infectious disease setting. We are working to create accurate and sensitive serological assays to potentially detect the presence of neutralizing antibodies that arise in response to the novel corona virus causing COVID-19 infection.

Corporate Highlights

In July 2020, the Company entered into two joint venture Business arrangements (JV) with BC Neuroimmunology Laboratory Inc. (BCNI). The first JV (JV1) will develop and market highly accurate, objective tests for the detection, diagnosis and monitoring of Alzheimer’s disease (AD). JV1 will offer existing blood-based assays for NfL (neurofilament light chain) and P-tau181 (phosphorylated tau181). Further assays will be developed, potentially incorporating our proprietary peptide antigens and tests for additional neurodegenerative diseases. The Company and BCNI each own 50% of JV1.
The second JV (JV2) will provide highly sensitive and specific serological assays for the detection and characterization of antibodies to the SARS-CoV-2 virus that is responsible for COVID-19. The Company and BCNI each own 50% of the JV2.
In September 2020, the Company announced initiation of a program to construct and test a multivalent peptide vaccine for AD. The critical first steps in vaccine development will be carried out by VIDO-InterVac, a global leader in vaccine research and development.
In September 2020, we announced the resignation of Anthony Giovinazzo from our Board of Directors.
Financial Results

Results of Operations – Three months ended September 30, 2020 and 2019

The Company’s net loss for the three months ended September 30, 2020 was $1,562,228, compared to a net loss of $1,637,714 for the three months ended September 30, 2019. Included in the net loss for the three months ended September 30, 2020 were non-cash expenses of $53,844, representing share-based compensation and amortization of an intangible asset, compared to $134,634 for the three months ended September 30, 2019. The decrease in the net loss for the three months ended September 30, 2020 reflects decreased consulting and professional fees, share-based compensation and foreign exchange losses offset by increased contract research organizations for internal programs and increased patent expenses.

Research and development expenses for the three months ended September 30, 2020 were $1,048,726, as compared to $1,053,123 in the three months ended September 30, 2019. The decrease in research and development expense for the three months ended September 30, 2020 is primarily attributed to decreased consulting and professional fees and share-based compensation, offset by increased contract research organizations for internal programs and increased patent expenses.

General and administrative expenses for the three months ended September 30, 2020 were $510,264, as compared to $584,602 in the three months ended September 30, 2019. The decrease in general and administrative expenses for the three months ended September 30, 2020 is primarily attributable to a decrease in foreign exchange losses and share-based compensation, offset by an increase in consulting and professional fees.

Results of Operations – Nine months ended September 30, 2020 and 2019

The Company’s net loss for the nine months ended September 30, 2020 was $4,974,365, compared to a net loss of $5,942,821 for the nine months ended September 30, 2019. Included in the net loss for the nine months ended September 30, 2020 were non-cash expenses of $343,892, representing share-based compensation, warrant modification and amortization of an intangible asset, compared to $551,968 for the nine months ended September 30, 2019. The decrease in the net loss for the nine months ended September 30, 2020 reflects decreased costs associated with contract research organizations for internal programs, decreased consultant costs, decreased professional fees, decreased share-based compensation and decreased foreign exchange losses, offset by increased patent expenses.

Research and development expenses for the nine months ended September 30, 2020 were $2,921,199, as compared to $3,866,294 in the nine months ended September 30, 2019. The decrease in the research and development expenses for the nine months ended September 30, 2020 reflects the conservation of cash resources and decreased costs associated with external contract research organizations for internal programs, decreased consulting and professional fees and decreased share-based compensation, offset by increased patent expense.

General and administrative expenses for the nine months ended September 30, 2020 were $2,051,506, as compared to $2,076,463 in the nine months ended June 30, 2019. The decrease for the nine months ended September 30, 2020 is primarily attributable to a reduction in consulting and professional fees and a decrease in foreign exchange losses offset by warrant modification expense.

Outlook

As a prelude to the first PMN310 clinical trial in AD, we will use a novel biomarker approach that may show evidence of slowing of neuronal death as early as the Phase 1 clinical study. As the ability to achieve early detection of AD develops, based on the advent of reliable blood-based biomarkers for AD detection, the need for preventive treatment will grow. Therapeutic vaccines can be used for this purpose. Using our discovery platform, our goal is to devise a safe and effective AD vaccine to induce a specific immune response against toxic oligomers of amyloid beta.

The Company will also continue to characterize the potential benefits of its programs selectively targeting toxic aggregates of TDP-43 in ALS, toxic forms of alpha-synuclein in PD and toxic aggregates of tau in AD and other dementias. Our unique platform produces antibodies that meet a key success factor for the development of therapeutics and vaccines for neurodegenerative diseases: the ability to selectively target the neurotoxic form of a protein implicated as a root cause of disease, while sparing normal forms of the protein.

In the infectious disease setting, we are working to create accurate and sensitive serological assays to potentially detect the presence of neutralizing antibodies that arise in response to a specific infection, such as COVID-19.

Achilles Therapeutics Announces Grant of European Patent Covering Use of Selectively Expanded T cells Targeting Clonal Neoantigens for the Treatment of Cancer

On November 11, 2020 Achilles Therapeutics Limited ("Achilles"), a clinical-stage biopharmaceutical company developing personalised cell therapies targeting clonal neoantigens, a novel class of tumour target, reported the decision by the European Patent Office ("EPO") to grant European patent EP3288581B, which covers the treatment of cancer using T cells that have been selectively expanded to target clonal neoantigens (Press release, Achilles Therapeutics, NOV 11, 2020, https://achillestx.com/achilles-therapeutics-announces-grant-of-european-patent-covering-use-of-selectively-expanded-t-cells-targeting-clonal-neoantigens-for-the-treatment-of-cancer/ [SID1234570569]).

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The patent is assigned to Cancer Research Technology and licensed exclusively to Achilles in certain fields. The inventors of EP3288581B include three of Achilles’ co-founders, Sergio Quezada, Chief Scientific Officer, Karl Peggs, Chief Medical Officer (effective January 2021) and Professor Charles Swanton, a Royal Society Napier Professor of Cancer and Chief Clinician at Cancer Research UK as well as Group Leader at the Francis Crick Institute and UCL.

A related patent was granted in Singapore in August 2020 with equivalent applications pending in multiple countries, including the United States. Many patent offices worldwide consider the status of equivalent European cases to be highly relevant to their patent granting decision.

"This is a significant and exciting decision by the EPO," said Dr. Iraj Ali, Chief Executive Officer of Achilles. "We are using Achilles’ innovative platform to rapidly advance our therapies for the treatment of solid tumours and have two ongoing clonal neoantigen T cell (cNeT) clinical trials; the CHIRON trial in patients with advanced non-small cell lung cancer (NSCLC) and the THETIS trial in patients with recurrent or metastatic malignant melanoma."

Tony Hickson, Cancer Research UK’s Chief Business Officer, said: "Achilles has made significant advances in the development of T cell therapies for cancer, and we are delighted to see the strides that they have taken since they were founded in 2016."