Paragon Biosciences Appoints Kerensa Jimenez as Paragon Health Capital Chief Executive Officer

On August 12, 2020 Paragon Biosciences reported the appointment of Kerensa Jimenez as the new chief executive officer of its capital markets group, Paragon Health Capital (PHC), a registered broker-dealer (Press release, Paragon Biosciences, AUG 12, 2020, View Source [SID1234563478]). With deep experience and a proven track record, Ms. Jimenez will spearhead all financings, mergers and acquisitions (M&A) advisory services, and capital planning for Paragon Biosciences’ portfolio of innovative life science companies.

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"Since 2017, Paragon Biosciences and its partners have invested or committed to invest more than $1 billion to build life science companies, and we expect ongoing investment of up to $500 million per year," said Jeff Aronin, founder, chairman and chief executive officer of Paragon Biosciences. "We have had the privilege of working closely with Kerensa for many years and believe her M&A and capital markets expertise will further enhance our capabilities as we continue on our mission of solving complex human and societal challenges by accelerating development of novel therapies and life science breakthroughs."

Ms. Jimenez brings more than 15 years of experience advising clients on M&A and financing transactions. Prior to joining Paragon Health Capital, she served as managing director of Octagon Capital Group, a top-tier merchant bank that has led numerous transactions for Paragon portfolio companies over the past several years. Earlier in her career, Ms. Jimenez was a director at Farlie Turner, a middle market investment bank, where she provided M&A advisory services to private equity clients and business owners in the healthcare, consumer, energy, and business services sectors. She received a Bachelor of Science in economics from the University of Pennsylvania’s Wharton School.

"Paragon Biosciences has an incredibly unique model to support focused, visionary companies with the long-term capital they need to further life science innovations including novel biopharmaceuticals, artificial intelligence-enabled life science products, and cutting-edge cell and gene therapies," said Ms. Jimenez. "I look forward to leading this important organization to support Paragon’s rapid growth."

Grant of Share Options under Share Option Scheme

On August 12, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that on August 11, 2020, it granted share options under the Share Option Scheme conditionally adopted by Chi-Med at its Annual General Meeting on April 24, 2015 (the "Share Option Scheme") (Press release, Hutchison China MediTech, AUG 12, 2020, https://www.chi-med.com/grant-of-share-options-under-share-option-scheme-200812/ [SID1234563472]). The scheme limit of the Share Option Scheme was refreshed on April 27, 2020.

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Chi-Med granted share options under its Share Option Scheme to employees to subscribe for a total of 1,155,000 Ordinary Shares represented by 231,000 American Depositary Shares ("ADSs") (each equating to five Ordinary Shares) subject to the acceptance of the grantees. Details of such share options granted prescribed are as follows:

Date of grant : August 11, 2020
Exercise price of share options granted : US$32.82 per ADS
Number of share options granted : 1,155,000 represented by 231,000 ADSs (five share options shall entitle the holder thereof to subscribe for one ADS)
Closing market price of ADSs on the date of grant : US$32.82 per ADS
Validity period of the share options : From August 11, 2020 to August 10, 2030

Celleron Therapeutics enters into a license agreement with Roche to improve the lives of patients living with tenosynovial giant cell tumour

On August 12, 2020 Celleron Therapeutics, the UK-based company developing novel medicines for cancer patients, reported the signing of a licensing agreement with Roche providing Celleron exclusive world-wide rights for the clinical development, manufacturing and commercialization of emactuzumab (Press release, Celleron, AUG 12, 2020, View Source [SID1234563471]). The closing is expected by end of 2020 after all conditions have been met.

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This license agreement of emactuzumab demonstrates Celleron’s commitment to cancer medicine development and its transformational potential for patients inflicted with cancer. Emactuzumab is a monoclonal antibody designed to target and deplete macrophages in the tumor tissue. It has shown a favourable safety profile in patients and very encouraging efficacy for diffuse tenosynovial giant cell tumour (TGCT), a rare disease characterised by the proliferation of macrophages in the synovial tissue in the joint and tendon sheath.

Professor Nick La Thangue, Chief Executive Officer of Celleron Therapeutics, commented: "We are very excited to be working on emactuzumab. Celleron’s commitment to developing transformative and novel therapies will ultimately allow emactuzumab to be brought to patients suffering from TGCT, which remains a very debilitating disease with limited clinical options."

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

On August 12, 2020 Kuraray reported Business Results for the Second Quarter of the Fiscal Year Ending December 31, 2020 (Press release, Kuraray, AUG 12, 2020, https://pdf.irpocket.com/C3405/PLDE/Hf1v/r28N.pdf [SID1234563464])

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1. Consolidated Financial Results for the Second Quarter of the Fiscal Year Ending December 31, 2020 (January 1, 2020 to June 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 Position

2. Dividends
1. Qualitative Information regarding Business Results
(1) Overview of Consolidated Business Results

In the second quarter of fiscal 2020 (January 1, 2020–June 30, 2020), the world economy saw a much clearer retraction as efforts to contain the spread of COVID-19 have failed to gain traction. 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 second quarter of fiscal 2020 are as follows: net sales fell ¥25,412 million, or 8.8%, compared with the previous fiscal year to ¥262,006 million; operating income decreased ¥8,310 million, or 29.8%, to ¥19,611 million; ordinary income decreased ¥7,047 million,
or 28.5%, to ¥17,638 million; and net income attributable to owners of the parent fell ¥4,093 million, or 30.9%, to ¥9,160 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 9.6% year on year to ¥121,809 million, and segment income fell 26.7% year on year to ¥16,924 million.

(1) The volume of PVA resin declined due to stagnant global demand. Although LCD panel manufacturers reduced inventory adjustments, shipments of optical-use poval film stayed level with the previous year due to effects from COVID-19 crisis. The sales of PVB film were weak 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 but sales for gas tank applications were heavily impacted by a decline in the number of vehicles produced.

Isoprene
Sales in this segment decreased 9.9% year on year to ¥24,720 million, and segment income
fell 38.6% year on year to ¥2,116 million.
(1) Sales of isoprene chemicals and SEPTON thermoplastic elastomer were affected by slowing 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 vehicle production.

Functional Materials
Sales in this segment decreased 5.5% year on year to ¥59,143 million, and segment income fell 52.4% year on year to ¥1,054 million.
(1) The overall methacrylate business was affected by worsening market conditions despite an increase in demand for spatter-blocking barrier panels.

(2) In the medical business, the dental materials business struggled, especially in the United States and Europe, as a result of an increase in dental clinic closures in response to spreading infections.

(3) As for Calgon Carbon, sales were steady even during COVID-19 crisis, this business’s products underpin people’s daily lives. In addition, in the Carbon Materials business, sales of high value-added products increased. Moreover, with expanding demand for high-performance activated carbon, we decided in this second quarter to expand the facilities at the U.S. plant of Calgon Carbon Corporation.

Fibers and Textiles
Sales in this segment fell 14.7% year on year to ¥28,224 million while segment income decreased 44.1% year on year to ¥1,656 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, the performance of KURALON for cement reinforcement use remained weak. Sales of products used in reinforcing rubber were negatively affected by a decline in the number of vehicles produced.
(3) In consumer goods and materials, sales of KURAFLEX were weak as demand for cosmetic and automotive applications stagnated despite an increase in the sales for mask-related applications.

Trading
In fiber-related businesses, sales of sewn products remained steady. However, sales of resins and chemicals were affected by lower demand in Japan and Asia. As a result, segment sales decreased 7.3% year on year to ¥60,037 million, and segment income rose 1.2% to ¥2,078 million.

Others
In other business, due to weak sales of domestic affiliates, segment sales declined 14.9% year on year to ¥22,155 million, and segment income fell 44.0% to ¥206 million.

(2) Overview of Financial Position
Total assets increased ¥92,640 million from the end of the previous fiscal year to ¥1,083,789 million mainly because of a ¥117,450 million increase in cash and cash deposits (due to an increase in liquidity undertaken in response to COVID-19 pandemic), a ¥10,686 million decrease in notes and accounts receivable—trade, and a ¥15,413 million decrease in
short-term investment securities. Total liabilities increased ¥98,903 million to ¥551,507 million due to factors that included the issuance of bonds payable totaling ¥30,000 million, a ¥36,000 million increase in commercial paper, and a ¥79,099 million increase in long-term loans payable, despite a ¥30,157 million decrease in accrued expenses.
Net assets fell ¥6,262 million to ¥532,282 million. Equity attributable to owners of the parent amounted to ¥517,189 million, for an equity ratio of 47.7%.

(3) Basis for the Revision in Forecasts, Including Consolidated Operating Results
Forecasts
The economy has receded significantly due to COVID-19 pandemic, and we assume that the effects will last into 2021 and beyond. We expect that demand will continue to stagnate for our operations in the third quarter onward accompanied by production adjustments.

The forecast of consolidated operating results for the fiscal year ending December 31, 2020 (January 1, 2020 to December 31, 2020) is as shown below.

(4) Notes regarding Quarterly Consolidated Financial Statements

1. 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 ¥6,214 million is the elimination of intersegment transactions of ¥776 million and corporate expenses of ¥6,991million. 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 ¥3,387 million in the second quarter of the fiscal year.

II. Second Quarter of Fiscal 2020 (January 1, 2020 to June 30, 2020)
1. Net sales, income and loss by reporting segment

1. The "Other Business" category incorporates operations not included in business segment eporting, including the environmental business and engineering business.
2. Adjustment is as follows: Included within segment loss of ¥4,425 million is the elimination of intersegment transactions of ¥1,044 million and corporate expenses of ¥5,470 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.

KAHR Medical Announces FDA Clearance of IND Application for DSP107, anti-CD47 Candidate for the Treatment of Solid Tumors

On August 12, 2020 KAHR Medical, a cancer immunotherapy company developing novel bi-functional fusion proteins, reported that the U.S. Food and Drug Administration has cleared its investigational new drug (IND) application for the Company’s lead product, DSP107, a second generation CD47x41BB targeting compound that simultaneously target cancer cells, weaken their innate defenses and activate an effective, local response of both innate and adaptive immunity (Press release, KAHR Medical, AUG 12, 2020, View Source [SID1234563454]).

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Under this IND, the Company intends to initiate a Phase I/II clinical trial to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of DSP107 as a monotherapy and in combination with Roche’s PD-L1-blocking checkpoint inhibitor (CPI) atezolizumab (Tecentriq) in patients with advanced solid tumors. The study will be conducted at multiple centers in the United States and site activation activities are currently underway.

"Receiving clearance from the FDA to advance our lead immuno-oncology program to the clinic marks a significant milestone for KAHR as we transform into a clinical-stage company," said Yaron Pereg, PhD, CEO, KAHR Medical. "DSP107, with its unique dual mechanism of action and its excellent safety profile with no hematological toxicities has the potential to become a best-in-class CD47 therapy. We are proud of our significant progress in recent years and look forward to initiating the Phase I/II study in the upcoming weeks for the benefit of patients suffering from challenging to treat cancers," added Dr. Pereg.

The planned Phase I/II study will evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of DSP107 in advanced solid tumors. The preliminary efficacy of both DSP107 monotherapy and combination therapy with atezolizumab will also be evaluated in patients with advanced non-small-cell lung carcinoma (NSCLC) who progressed after treatment with PD-1/PD-L1 inhibitors. The study will be conducted under a clinical collaboration with Roche.

About DSP107

DSP107 targets CD47-overexpressing tumors, simultaneously blocking macrophage inhibitory signals and delivering an immune costimulatory signal to tumor antigen-specific, activated T-cells. CD47 is overexpressed on many cancer cells and binds SIRPα on immune phagocytic cells to produce a "don’t eat me" signal. DSP107 binds CD47 on cancer cells, blocking interaction with SIRPα and thus, blocking the "don’t eat me signal". Simultaneously, DSP107 binds 41BB on T-cells, stimulating their activation. These activities lead to targeted immune activation through both macrophage and T-cell mediated tumor destruction.