On November 10, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC), reported that CEO Rachel King plans to present an overview of the company at the upcoming Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17 and the Jefferies Virtual London Healthcare Conference on Thursday, November 19 (Press release, GlycoMimetics, NOV 10, 2020, View Source [SID1234570480]). Both presentations will be available on the Company’s website, under the Investors tab. Details are as follows:

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Stifel 2020 Virtual Healthcare Conference
November 16-18, 2020
GlycoMimetics presentation: Tuesday, November 17, 8:00 a.m. (EST)

Jefferies Virtual London Healthcare Conference
November 17-19, 2020
GlycoMimetics presentation: Thursday, November 19, 6:45 – 7:15 (BST)

On November 10, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the third quarter ended September 30, 2020 (Press release, Curis, NOV 10, 2020, View Source [SID1234570479]).

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"We have continued to advance our clinical programs towards important catalysts at the end of this year and into 2021, which we expect to be another important year of data for Curis," said James Dentzer, President and Chief Executive Officer of Curis. "We have been pleased with the enrollment progress of our first-in-class IRAK4 inhibitor, CA-4948, in a Phase 1 study in patients with non-Hodgkin’s lymphoma (NHL), and we look forward to providing an update at ASH (Free ASH Whitepaper). We began a second Phase 1 study for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) and we are pleased to announce today a CRADA with the NCI for further development of CA-4948 as an anti-cancer agent. We also look forward to initiating our Phase 1 combination study evaluating CA-4948 and the BTK inhibitor, ibrutinib, in patients with NHL, including those with MYD88 altered disease."

Mr. Dentzer continued, "We also initiated patient dosing during the third quarter in our VISTA program, CI-8993, in the Phase 1a/1b study for patients with relapsed / refractory solid tumors. We are excited about our rapid progress from IND approval to patient dosing in this study and look forward to providing more updates over the coming quarters."

Third Quarter 2020 and Recent Operational Highlights

Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

Curis is evaluating CA-4948 in an ongoing Phase 1 dose-escalation study for the treatment of patients with R/R NHL, including patients with diffuse large B-cell lymphoma (DLBCL), Waldenström’s macroglobulinemia (WM) and oncogenic MYD88 mutations. An update of safety and efficacy data from the trial will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held virtually from December 5-8, 2020.
Curis continues to enroll patients in a second open-label Phase 1 dose-escalation study of CA-4948 in patients with R/R AML and high-risk MDS, including patients with spliceosome mutations that drive expression of the long isoform of IRAK4 (IRAK4-L). The primary objective of the study is to determine the maximum tolerated dose and recommended Phase 2 dose of CA-4948 based on safety and tolerability, dose-limiting toxicities (DLTs), and pharmacokinetic and pharmacodynamic findings. A minimum of three patients will be enrolled at each dose level, starting with 200 mg BID, which was determined to be safe, capable of achieving relevant levels of drug exposure, and demonstrated signs of biologic activity and clinical efficacy in a separate, ongoing Phase 1 study. Initial data from the study will be presented in a Trial in Progress poster at ASH (Free ASH Whitepaper).
Today, Curis announced that it entered into a CRADA with the NCI’s Experimental Therapeutics Program for the development of CA-4948. Under the agreement, the NCI and Curis will collaborate on the non-clinical and clinical development of Curis’s proprietary compound CA-4948, an IRAK-4 kinase inhibitor that acts as a Toll-like Receptor (TLR) suppressor as an anti-cancer agent.
Curis expects to initiate a Phase 1 study evaluating CA-4948 in combination with ibrutinib, a BTK inhibitor. In preclinical models, CA-4948 has demonstrated anti-cancer activity that is highly synergistic with BTK inhibition. The Company will present a Trial in Progress poster at ASH (Free ASH Whitepaper).
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

Curis initiated patient dosing in Q3 in a Phase 1a/1b study of CI-8993 in patients with relapsed / refractory solid tumors.
Curis will present a Trial in Progress poster on CI-8993 at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, which is being held virtually from November 9-14, 2020.
Corporate:

As of November 3, 2020, extended cash runway through the second quarter of 2021, as a result of aggregate proceeds of approximately $10.0M since June 30, 2020 from the Company’s at-the-market sales agreement with JonesTrading and stock purchase agreement with Aspire Capital.
Upcoming 2020 Planned Milestones

Declare the recommended Phase 2 dose for CA-4948 in the ongoing lymphoma Phase 1 study and report updated efficacy data from the study later this quarter.
Report initial data later this quarter from the Phase 1 study of CA-4948 in patients with AML/MDS, including patients with spliceosome mutations that encode oncogenic IRAK4-L.
Continue enrollment in Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors.
Initiate Phase 1 study of CA-4948 in combination with ibrutinib.
Third Quarter 2020 Financial Results

For the third quarter of 2020, Curis reported a net loss of $6.0 million, or $0.11 per share on both a basic and diluted basis, as compared to a net loss of $6.4 million, or $0.19 per share on both a basic and diluted basis, for the same period in 2019. Curis reported a net loss of $22.4 million, or $0.52 per share on both a basic and diluted basis, for the nine months ended September 30, 2020 as compared to a net loss of $23.5 million, or $0.71 per share on both a basic and diluted basis for the same period in 2019.

Revenues for the third quarter of 2020 were $2.7 million, as compared to $2.9 million for the same period in 2019. Revenues for the nine months ended September 30, 2020 were $7.8 million, as compared to $6.7 million for the same period in 2019. Revenues for all periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses for the third quarter of 2020 were $7.5 million, as compared to $8.2 million for the same period in 2019. Operating expenses for the nine months ended September 30, 2020 were $26.4 million, as compared to $23.7 million for the same period in 2019, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were stable at $0.1 million for the third quarter of 2020, as compared to $0.1 million for the same period in 2019. Cost of royalty revenues for the nine months ended September 30, 2020 were $0.4 million, as compared to $0.3 million for the same period in 2019.

Research and Development Expenses. Research and development expenses were $4.7 million for the third quarter of 2020, as compared to $5.1 million for the same period in 2019. The decrease in research and development expenses for the quarter is primarily attributable to reduced clinical trial costs related to CA-170 and fimepinostat. Research and development expenses were $17.5 million for the nine months ended September 30, 2020, as compared to $14.8 million for the same period in 2019.

General and Administrative Expenses (G&A). General and administrative expenses were $2.6 million for the third quarter of 2020, as compared to $2.9 million for the same period in 2019. The decrease was driven primarily by lower personnel and stock-based compensation costs partially offset by higher legal, professional and consulting services costs. General and administrative expenses were $8.6 million for the nine months ended September 30, 2020, as compared to $8.6 million for the same period in 2019.

Other expense, net. Net other expense was $1.3 million for the third quarter of 2020, as compared to $1.1 million for the same period in 2019. Net other expense for the third quarter 2020 primarily consisted of imputed interest expense related to future royalty payments. Net other expense was $3.8 million for the nine months ended September 30, 2020, as compared to $6.5 million for the same period in 2019.

As of September 30, 2020, Curis’ cash, cash equivalents, marketable securities and investments totaled $23.6 million and there were approximately 56.7 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations through the second quarter of 2021.

Conference Call Information

Curis management will host a conference call today, November 10, 2020, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

On November 10, 2020 Lion TCR reported that it has presented two abstracts at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 9-14 (Press release, Lion TCR, NOV 10, 2020, View Source [SID1234570478]). Each of these abstracts highlights the good safety profile and efficacy of LioCyx-M and the promising use of HBV-specific TCR-T therapy in HBV-related HCC.

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TCR-T immunotherapy involves the bioengineering reprogramming of the human body’s natural immune defenders, T cells, to enhance their cytolytic specificity function against tumour cells. Our clinical data presented in these abstracts supports the use of Lion TCR’s lead T-cell product, LioCyx-M is a promising TCR-T immunotherapy for primary hepatocellular carcinoma (HCC) and recurrence post liver transplantation.

Each of these abstracts highlights the good safety profile and efficacy of our lead product LioCyx-M, autologous T cells modified to express Hepatitis B virus (HBV)-specific TCR, as monotherapy in either unresectable HBV-associated hepatocellular carcinoma (HCC) or recurrent HCC post liver transplantation in two independent Phase I studies. These data demonstrate the promising use of HBV-specific TCR-T therapy in HBV-related HCC.

Details of the posters are as follows:

Title Use of LioCyx-M, Autologous Hepatitis B Virus (HBV)-Specific T cell receptor (TCR) T-cells, in Advanced HBV-related Hepatocellular Carcinoma (HCC)
Abstract # 272
Co-corresponding authors Antonio Bertoletti and Fu-Sheng Wang
Presenting Author Fanping Meng
ClinicalTrials.gov number NCT03899415
Title Phase I Study of LioCyx-M, Autologous Hepatitis B Virus (HBV)-Specific T cell receptor (TCR) T-cells, in Recurrent HBV-Related Hepatocellular Carcinoma (HCC) Post-Liver Transplantation
Abstract # 273
Co-corresponding authors Antonio Bertoletti and Qi Zhang
Presenting Author Jintao Cheng
ClinicalTrials.gov number NCT02719782
The full abstracts are attached in this release and are also published online on 8 a.m. EST on Monday, Nov. 9, 2020 in Journal for ImmunoTherapy of Cancer (JITC).

On November 10, 2020 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported a preclinical data presentation for E7777 (denileukin diftitox), its engineered IL-2-diphtheria toxin fusion protein, at the The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, being held virtually (Press release, Dr Reddy’s, NOV 10, 2020, View Source [SID1234570477]).

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Dr. Anil Namboodiripad, Senior Vice President and Head of Dr. Reddy’s Proprietary Products Division stated, "We are encouraged that in addition to the clinically demonstrated safety and activity of denileukin diftitox in patients with cutaneous T cell lymphoma, these new syngeneic mouse model studies show that E7777 also shows promising activity as a potential immunotherapy agent for treatment of solid tumors. Combination of E7777 with an anti-PD-1 agent provided clear benefit both in terms of tumor growth control, and a highly significant improvement in overall survival. We look forward to conducting clinical trials to further explore this combination."

Key findings from the presentation are included below.

Title: E7777 (Denileukin Diftitox) Enhances Anti-Tumor Activity and Significantly Extends Survival Benefit of Anti-PD-1 in Syngeneic Solid Tumor Models

 E7777 administered as monotherapy inhibited tumor growth with activity comparable to anti-PD1 monotherapy in syngeneic murine tumor models
 Combination of E7777 and anti-PD-1 inhibited tumor growth substantially better than monotherapy treatments Administration of E7777 and anti-PD-1 for a limited treatment period led to highly significant improvements in long-term survival
 Combination of E7777 and anti-PD-1 was administration schedule independent

On November 10, 2020 Kureha Corporation reported that (Press release, Kureha Corporation, NOV 10, 2020, View Source [SID1234570476])

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1. FY2020 Half-Year Results (Period April 1-September 30, 2020)  FY2020 1H operating profit: ¥6.2bn (down ¥4.1bn YoY)

• Limited impact of COVID on manufacturing and sales operations
• Challenging market conditions for Advanced Materials with slower automobile and shale oil production
• Primary factors attributing to operating profit:-¥2.9bn operating loss in the PGA business due to lower sales volumes (-¥1.5bn) and temporary cost of sales related to PGA manufacturing facility*(-¥1.4bn) *

There was no resin production at the US PGA plant in the 1H period, and expenses related to the plant were all temporarily recorded as cost of sales (to be incurred as inventory assets after PGA production in 3Q)

-Lower sales volumes in other businesses due to COVID-related economic slowdown, business transfer (blow bottle), effects of mandatory drug price revisions, etc. (-¥1.9bn)-Absence of a discount business purchase gain recorded in prior year (-¥1.5bn)-Lower raw materials and fuel cost (+¥0.9bn)

-Lower SG&A expenses amid COVID (+¥1.3bn) 

Shareholder returns and cash flow
• FY2020 interim dividend: ¥85 per share (same amount as FY2019) FY2020 year-end dividend: ¥85 per share (same amount as FY2019)
• The balance of cash and cash equivalents at the end of FY2020 1H amounted to ¥17.6bn (¥10.3bn up from FY2019 1H end) including cash from sale of investment securities, which will be used for further capital investment while hedging against credit risks amid COVIDRevenue down on lower sales volumes in Advanced Materials, Specialty Chemicals and Specialty Plastics’ packaging materials business, partially offset by higher Construction and environmental business volumes
• Operating profit down due largely to lower PGA volumes and temporary cost of sales related to the US PGA plant combined with the lack of prior year’s bargain business purchase gain, partially offset by margin expansion in environmental businesses
• Profit for the period decreased on lower operating profit and profit before income tax AM: Decline driven by PPS, PGA and carbon products, despite improved earnings for PVDF SC: Decline in industrial chemicals more than offsetting higher profit in agrochemicals SP: Profit even with prior year due to profit increase for fishing lines offset by a decline in packaging materials CO: Profit even with prior year despite higher sales volumes in the civil engineering business OO:

Growth driven by higher environmental engineering business volumesAdvanced plastics PPS: Profit declined on lower volumes for automobile applications and lower equity income in affiliates PVDF: Higher profit driven by volume growth for LiB binder applications, partially offset by declines in other applications PGA: Revenue down on lower frac plugs and stock shapes volumes as shale oil production slowed with falling oil prices; a sharp decline in operating profit resulting from temporary cost of sales related to the US plant (plant expenses temporarily recorded due to no production in 1H) Carbon products Profit down on lower carbon fiber sales volume for automobile and furnace insulation applications Other Profit even with prior year despite higher adhesive sales volumeAgrochemicals Higher profit driven by higher fungicides volumes Pharmaceuticals Profit improved on lower expenses, despite a decline in sales affected by the National Health Insurance drug price revisions Industrial chemicals Revenue and profit decreased due to slower demand for organic and inorganic chemicals amid COVID-related slumpHome products / Fiber products Higher profit driven by volume growth for ‘Seaguar’ fishing lines, despite flat home products sales Packaging materials Profit declined due to slower sales of heatshrink multilayer film in EU and Australia meat markets amid COVID, combined with effects of the transfer of the blow-bottle business (divested in FY2019)

Construction Revenue up on higher number of civil engineering projectsEnvironmental Engineering Profit growth driven by higher industrial waste processing and treatment volumes Logistics Revenue and profit even with prior year Hospital Operations Declines in revenue and profitFY2020 Full-year forecast: ¥14.5bn in operating profit (¥3.5bn down YoY)

• Sales expected to pick up from 3Q onward at a varying speed for each segmentAdvanced Materials exclusive of PGA to record ¥1.1bn increase in operating profit
• Expansion of environmental engineering business driven by higher industrial waste treatment volumes
• Operating profit of ¥14.5bn projected based on core operating profit at ¥15bn (¥1.0bn down YoY) and a ¥2.5bn decrease in the net effect of other income and expenses (gains from fixed asset sales and business restructuring cost recorded in FY2019)

 Capital investment PPS: 5000 ton capacity increase at Iwaki Factory; commercial operations scheduled for February 2021 PVDF: Monomer process enhancements at Iwaki Factory; commercial operations scheduled for April 2022 Revenue decline led by:-Slower PGA demand in sluggish shale market-Effects of the bottle business transfer-Slower demand for industrial chemicals partly offset by-Higher PVDF volume for LiB binder applications-Expansion of the environmental business

• Operating profit down due to lower segment operating profit led by Advanced Materials and a decrease in the net effect of other income and expenses
• Profit before income tax to decrease on lower operating profit
• Profit for the period to decrease on lower profit before income taxAM: PGA-related operating loss more than offsetting PVDF volume growth SC: Improved demand for agrochemicals after prior year’s inventory adjustments SP: Slower sales for packaging materials more than offsetting volume growth of fishing lines CO: Fewer high-margin projects and intensified market competition OO: Higher environmental engineering business volumesAdvanced plastics: Revenue down, profit down

-Negative impact of falling oil prices and slower shale oil production on PGA sales-Slower demand for PPS in auto market

-Robust volume growth of PVDF LiB binder in the EV market supported by environment and economic policies Carbon products: Revenue down, profit down-Decreased sales of carbon fiber used for automobile sliding parts Other: Revenue up, profit up-Increasing demand for high-performance materials in recovering semiconductor and 5G marketsAgrochemicals: Revenue up, profit up-Improved demand for agrochemicals after customers’ inventory adjustments Pharmaceuticals: Revenue down, profit down

-Effects of mandatory drug price revisions and distribution inventory adjustments Industrial chemicals: Revenue down, profit down-Slower demand for organic and inorganic chemicalsHome products & Fiber products: Revenue up, profit up-Continued demand for fishing lines due to increasing popularity of recreational fishing amid the pandemic-Flat sales growth for home products (NEW Krewrap, Kichinto-san series) Packaging materials: Revenue down, profit down-Slower sales of heat-shrink multilayer film in EU and Australia meat markets amid COVID-Effects of the transfer of the blow-bottle business (divested in FY2019)Construction: Revenue down, profit down-Decrease in high-margin construction projects-Intensified market competitionEnvironmental engineering: Revenue up, profit up-Higher industrial waste processing and treatment volumes related particularly to low PCB concentration wastes Logistics: Revenue down, profit down-Slower demand in and outside the Group Hospital operations: Revenue down, profit down-Fewer number of visiting patients

3. Consolidated Companies

4. Supplementary Marketing strategy for business expansion By improving the current PGA frac plugs and offering price flexibility for customers, we aim to promote PGA frac plugs for use in the entire horizontal wellbore and increase sales volume.

② Technological strategy for business expansion As a first step, we will develop a differentiated nonPGA dissolvable frac plug by leveraging our original technologies to enhance the product lineup, and begin to sell the plug in areas with low-tomiddle ground temperatures. Next we will develop a PGA frac plug targeted for the ultra-low-to-low temp areas and expand the sale of PGA frac plugs in all temperature areas.Primary customers are major South Korean and Chinese lithium-ion battery (LiB) makers

• Maintains a roughly 40% share in the automotive LiB cathode binder market

• LiB production was largely disrupted due to COVID during the first six months of FY2020, but the market is rapidly recovering on the back of tighter environmental regulations and economic stimulus policies

• Commenced production and supply of PVDF binder specialty grades at the China Changshu plant in May 2020

• Will continue to study for additional PVDF manufacturing facility, although delayed due to COVID, and will release details including its location (most likely in China) by Spring 2021. Commercial operations of the new plant is scheduled to start in FY2024 Kureha Ecology Management (KEM) leverages its waste treatment technologies for hard-to-detoxify wastes such as industrial wastes with low polychlorinated biphenyl (PCB) concentration and chlorine-and fluorine-based halogen compounds

• In FY2019, KEM acquired full ownership of Himeyuri Total Work Co. which owned a final treatment site for industrial wastesKureha’s basic policy for the distribution of earnings is to strengthen the company overall to realize longerterm growth, prepare for future business expansion, enhance retained earnings, and provide a stable and continued dividend.

◼ Share repurchase allows flexible capital management and is considered as a viable option. *Presently Kureha is closely watching for any credit risks and effects of COVID on the financial market and has no plan to repurchase its own shares. These materials are supplied to provide a deeper understanding of our company, and are not intended to as a solicitation for investment or other actions.

• These materials have been prepared by our company based on the information available at this point in time. However, actual performance may produce results that differ from the plan due to unforeseeable events and factors.

• Please utilize these materials using you own judgment and responsibility.