Calithera to Participate in Jefferies Virtual Healthcare Conference and SVB Leerink Oncology 1×1 Day

On November 11, 2020 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported its participation at two upcoming healthcare investor conferences in November (Press release, Calithera Biosciences, NOV 11, 2020, View Source [SID1234570583]).

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Jefferies Virtual Healthcare Conference. Susan M. Molineaux, Ph.D., the company’s founder, president and chief executive officer will present on Wednesday, November 18, 2020, at 2:20 p.m. Eastern Time. The presentation will be webcast live and available for replay for up to 30 days at www.calithera.com in the Investor Relations section.
SVB Leerink Oncology 1×1 Day. The company will host virtual meetings with investors on Thursday, November 19, 2020.

HOOKIPA Pharma to Participate in Upcoming Investor Conferences in November

On November 11, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that HOOKIPA’s management team will participate in two upcoming virtual investor conferences (Press release, Hookipa Pharma, NOV 11, 2020, View Source [SID1234570582]):

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The SVB Leerink Oncology 1×1 Day, November 19, 2020
The Piper Sandler 32nd Annual Virtual Healthcare Conference, November 30 – December 3, 2020
HOOKIPA will participate in virtual one-on-one meetings during these events.

Deciphera Presents Updated Preliminary Data from DCC-3014, its CSF1R Inhibitor Program, in Tenosynovial Giant Cell Tumor Patients at the Connective Tissue Oncology Society (CTOS) 2020 Virtual Annual Meeting

On November 11, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), reported the presentation of encouraging preliminary results from the ongoing Phase 1/2 study of DCC-3014, a highly selective, oral, investigational switch-control kinase inhibitor of CSF1R, in patients with tenosynovial giant cell tumor (TGCT) (Press release, Deciphera Pharmaceuticals, NOV 11, 2020, View Source [SID1234570581]). The presentation, titled "Phase 1 Dose-Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DCC-3014 in Advanced Solid Tumors and Tenosynovial Giant Cell Tumor (TGCT)", will be presented at the CTOS 2020 Virtual Annual Meeting, being held November 18-21, 2020. Posters and presentations are available to meeting participants as of November 11, 2020.

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"We are very encouraged by the updated data in additional TGCT patients from the ongoing Phase 1/2 study of DCC-3014," said Matthew L. Sherman, MD, Executive Vice President and Chief Medical Officer of Deciphera. "The preliminary results presented in TGCT patients at the CTOS 2020 Virtual Annual Meeting demonstrated highly encouraging evidence of anti-tumor activity, and DCC-3014 was shown to be generally well-tolerated. These results further support the evaluation of DCC-3014 in patients with TGCT and bolster our confidence in its potential to make a meaningful impact in this disease, which is typically associated with progressively reduced mobility and function. We have selected the recommended Phase 2 dose and initiated the TGCT expansion cohorts to further evaluate the safety and efficacy of DCC-3014."

"TGCT is a rare and debilitating disease that is most often treated with surgery," said William D. Tap, MD, Chief of the Sarcoma Medical Oncology Service at Memorial Sloan Kettering Cancer Center in New York. "Despite the best surgical intervention, the disease may advance to the point where surgery is no longer an option, and so there remains a need for effective, well-tolerated systemic therapies to help these patients. These preliminary results demonstrate that DCC-3014 has the potential to be a safe and effective treatment option for TGCT patients."

The Company’s international, multicenter, open-label Phase 1/2 study of DCC-3014 was designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of DCC-3014 in patients with malignant solid tumors and TGCT. Data presented at the CTOS 2020 Virtual Annual Meeting are from 25 TGCT patients enrolled in the dose-escalation portion of the Phase 1/2 study. The cutoff date for the safety data was September 23, 2020, and the cutoff date for the efficacy data was October 5, 2020.

Preliminary results from DCC-3014 in TGCT patients:

Dose Cohorts and Demographics

25 TGCT patients enrolled in the study in three dose cohorts:
Cohort 5 (n=7): 30 mg loading dose daily for five days followed by a maintenance dose of 30 mg twice a week;
Cohort 8 (n=12): 30 mg loading dose daily for three days followed by a maintenance dose of 10 mg daily; and
Cohort 9 (n=6): 20 mg loading dose daily for three days followed by a maintenance dose of 6 mg daily.
Seven patients (28%) had at least one prior surgery and four patients (16%) had received at least one prior systemic therapy.
Preliminary Efficacy and Duration of Treatment

22 patients were evaluable for efficacy by RECIST v1.1 at the data cutoff with central assessment available for 21 of the 22 patients; three patients had not yet reached first efficacy assessment.
Objective response rate of 41%.
Nine of 22 patients achieved an objective response, including one complete response.
Of the nine responses, three were confirmed and six are awaiting confirmation.
78% of responders (7 of 9 patients) had a partial response at their first restaging scan at Cycle 3 Day 1 (week 9).
22 of 25 patients were receiving treatment with DCC-3014 at the data cutoff. Two patients withdrew from the study and one patient discontinued due to an adverse event.
Two TGCT patients were on treatment for 12 or more months with responses that deepened over time.
Safety and Tolerability

Treatment with DCC-3014 was generally well-tolerated in patients with TGCT not amenable to surgery. One patient (4%) discontinued treatment due to an adverse event (asymptomatic Grade 3 AST elevation, from Grade 1 at baseline).
Treatment-emergent adverse events (TEAEs) (mostly grade 1/2) occurring in ≥25% of patients with TGCT regardless of relatedness were blood creatine phosphokinase (CPK) increased (52%), aspartate amino transferase (AST) increased (44%), periorbital edema (44%), fatigue (40%), lipase increased (32%), and alanine aminotransferase (ALT) increased (28%). No serious adverse events related to DCC-3014 were reported.
All bilirubin levels were within the normal limit.
Observed transaminase and pancreatic enzyme elevations were asymptomatic and not clinically significant.
Pharmacokinetics, Pharmacodynamics and Recommended Phase 2 Dose

Similar steady state pharmacokinetic profiles were observed between the 30 mg twice weekly (cohort 5) and 10 mg daily (cohort 8) dosing regimens; lower exposure was observed in the 6 mg daily (cohort 9) dosing regimen.
Across all cohorts, DCC-3014 treatment resulted in an increase in plasma CSF1/IL-34 and a decrease in non-classical sub-type of monocytes, indicating pharmacodynamic inhibition of CSF1R.
The recommended Phase 2 dose for DCC-3014 in TGCT patients was determined to be 30 mg twice weekly (no loading dose).
Based on these encouraging results, the Phase 1/2 study of DCC-3014 is ongoing and enrolling up to 60 patients into two expansion cohorts, one for TGCT patients with no prior exposure to anti-CSF1/CSF1R agents (n=40) and a second for patients with prior exposure to anti-CSF1/CSF1R agents (n=20). In addition, enrollment of an additional six patients in cohort 9 of the dose escalation portion of the study is ongoing to complete enrollment in this cohort.

About Tenosynovial Giant Cell Tumor (TGCT)
TGCT is a rare disease caused by a translocation in colony-stimulating factor 1 (CSF1) gene resulting in overexpression of CSF1 and recruitment of colony-stimulating factor 1 receptor (CSF1R)-positive inflammatory cells into the lesion. TGCT is also known as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS), a diffuse-type of TGCT. Although benign, these tumors can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint. Surgery is the main treatment option; however, these tumors tend to recur, particularly in diffuse-type TGCT. If untreated or if the tumor continually recurs, damage and degeneration may occur in the affected joint and surrounding tissues, which may cause significant disability.

About DCC-3014
DCC-3014 is an investigational, orally administered, potent and highly selective switch-control kinase inhibitor of CSF1R. DCC-3014 was designed using the Company’s proprietary discovery platform to selectively bind to the CSF1R switch pocket. Through inhibition of CSF1R, DCC-3014 has demonstrated encouraging preliminary efficacy and safety data in tenosynovial giant cell tumor (TGCT) and is currently being evaluated in a Phase 1/2 clinical study. For more information about the clinical trial design, please visit www.clinicaltrials.gov (NCT03069469).

Bio-Techne To Present At The Stephens Annual Investment Conference 2020

On November 11, 2020 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Stephens Annual Investment Conference 2020 on Tuesday, November 17, 2020 at 3:00 p.m. EST (Press release, Bio-Techne, NOV 11, 2020, https://investors.bio-techne.com/news/detail/222/bio-techne-to-present-at-the-stephens-annual-investment-conference-2020 [SID1234570580]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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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.