On November 10, 2021 Kuraray reported that (Press release, Kuraray, NOV 10, 2021, https://pdf.irpocket.com/C3405/l3Fa/TF2c/T3bA.pdf [SID1234595213])

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1. Consolidated Financial Results for the Third Quarter of the Fiscal Year Ending December 31, 2021 (January 1, 2020 to September 30, 2021)
(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
3. Forecasts of Consolidated Financial Results for the Fiscal Year Ending December 31, 2021 (January 1, 2021 to December 31, 2021) (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.)

1. Qualitative Information regarding Business Results
(1) Overview of Consolidated Business Results In the third quarter of fiscal 2021 (January 1, 2021–September 30, 2021), the world economy recovered overall as COVID-19 vaccinations rates continued to rise and economic activities have been invigorated, particularly in advanced countries and China. However, the outlook is currently growing more unclear due mainly to a continued rise in raw material and fuel prices in addition to shortages of semiconductors and other components, prolonged logistics disruptions, and concerns about an economic slowdown in China. Consequently, consolidated operating results for the third quarter of fiscal 2021 are as follows: net sales rose ¥65,380 million, or 16.6%, compared with the previous fiscal year to ¥459,159 million; operating income increased ¥21,790 million, or 67.0%, to ¥54,318 million; ordinary income increased ¥21,178 million, or 71.0%, to ¥51,001 million; and net income attributable to owners of the parent increased ¥13,455 million, or 88.8%, to ¥28,602 million.

The Group’s long-term vision for its 100th anniversary coming up in 2026, "Kuraray Vision 2026", is to become a "Specialty Chemical Company, growing sustainably by incorporating new foundational platforms into its own technologies." We will continue striving to optimize our business portfolio by steadily taking specific measures based on the three basic policies of "Kuraray Vision 2026": pursuing competitive superiority, expanding new business fields and enhancing the comprehensive strengths of the Kuraray Group. In fiscal 2021, we will focus on safe and stable operations amid the pandemic and thoroughly implement various measures decided on during the period of the previous medium-term management plan "PROUD 2020." At the same time, we will move ahead with formulating the next medium-term management plan, which is set to start in fiscal 2022.Results by Business Segment Vinyl Acetate Sales in this segment increased 20.4% year on year to ¥224,861 million, and segment income rose 53.3% year on year to ¥42,926 million.

(1) Sales of PVA resin increased for a wide range of applications as global demand has been recovering, but performance was impacted by high raw material and fuel prices. Sales of optical-use poval film were brisk against a backdrop of robust demand for LCD panels continuing from the second half of the previous fiscal year. The sales volume of PVB film rose year on year but were affected by a decrease in the production of automobiles caused by a shortage of semiconductors in the third quarter. Sales of water-soluble PVA film steadily expanded for use in unit dose detergent packets, including for laundry and dish detergents.
(2) The sales volume of EVAL ethylene vinyl alcohol copolymer (EVOH resin) increased due to a recovery in demand for gas tank applications and solid demand for food packaging applications but were affected by a decrease in the production of automobiles and high raw material and fuel prices in the third quarter.

On November 10, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported its financial results for the third quarter and the first nine months of 2021 (Press release, MorphoSys, NOV 10, 2021, View Source [SID1234595230]).

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"Monjuvi sales continued to build momentum in the third quarter where we saw a broadening of the prescriber base and increased utilization in second-line patients," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We are excited to share new data for Monjuvi and pelabresib at the upcoming ASH (Free ASH Whitepaper) conference. For pelabresib, we will share the latest data from our MANIFEST trial, including important data from the third combination arm that confirm previous results. This further underpins our confidence in the ongoing phase 3 MANIFEST-2 study."

Tafasitamab Highlights

– Monjuvi(R) (tafasitamab-cxix) U.S. net product sales of € 18.6 million (US$ 22.0 million) for the third quarter of 2021 and € 46.4 million (US$ 55.5 million) for the first nine months of 2021.

– On August 24, 2021, Health Canada granted conditional marketing authorization for Minjuvi(R) (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma

– On August 26, 2021, MorphoSys and Incyte announced that the European Commission granted conditional marketing authorization for Minjuvi(R) (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

– In the third quarter 2021, MorphoSys received, for the first time, royalty revenue of € 82 thousand for Minjuvi sales outside of the U.S. pursuant to the agreement with Incyte.

Other Highlights after the end of the third quarter of 2021

– On October 20, 2021, MorphoSys announced that the first patient has been dosed in the Phase 2 IGNAZ clinical trial evaluating felzartamab for patients with Immunoglobulin A Nephropathy (IgAN). IgAN, also known as Berger’s disease, is a chronic and debilitating autoimmune disease affecting the kidneys and the most common glomerular disease worldwide.

– On November 4, 2021, MorphoSys announced the presentation of interim results from
M-PLACE, the ongoing Phase 1b/2a, proof of concept study with felzartamab at the 2021 Annual Meeting of the American Society of Nephrology (ASN).

– On November 4, 2021, MorphoSys announced that new data on tafasitamab and pelabresib will be presented during the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 11-14, 2021. Ten abstracts were accepted, including two oral presentations on the MANIFEST and RE-MIND2 clinical studies.

Financial Results for the Third Quarter of 2021 (IFRS)
Total revenues for the third quarter of 2021 amounted to € 41.2 million (Q3 2020: € 22.0 million). The Group revenues include revenues of € 18.6 million from the recognition of Monjuvi(R) product sales in the US.

Cost of Sales: In the third quarter of 2021, cost of sales increased to € 7.5 million (Q3 2020: € 3.7 million).

Research and Development (R&D) Expenses: In the third quarter of 2021, R&D expenses were € 64.4 million (Q3 2020: € 34.2 million). The increase in R&D expenses is primarily due to the inclusion of R&D expenses from Constellation and higher investment to support the advancement of clinical programs.

Selling, General and Administrative (SG&A) Expenses: Selling expenses decreased in the third quarter of 2021 to € 32.4 million (Q3 2020: € 32.9 million) and general and administrative (G&A) expenses amounted to € 19.4 million (Q3 2020: € 13.3 million). The increase of G&A expense in the third quarter was driven by transaction costs for the acquisition of Constellation and the inclusion of Constellation’s G&A expenses.

Operating Loss: Operating loss amounted to € 82.4 million in the third quarter of 2021 (Q3 2020: operating loss of € 62.0 million).

Consolidated Net Profit / Loss: For the third quarter of 2021, consolidated net loss was € 112.8 million (Q3 2020: consolidated net loss of € 65.3 million).

Financial Results for First Nine Months of 2021 (IFRS)

Total revenues for the first nine months of 2021 amounted to € 126.7 million (9M 2020: € 291.7 million). The Group revenues include revenues of € 46.4 million from the recognition of Monjuvi(R) product sales in the US. The year-over-year decline was driven by the upfront payment of the collaboration and license agreement with Incyte in the first quarter 2020 for the out-licensing of tafasitamab outside the U.S.

Cost of Sales: In the first nine months of 2021, cost of sales increased to € 22.7 million (9M 2020: income of € 0.2 million).

Research and Development (R&D) Expenses: In the first nine months of 2021, R&D expenses were € 138.2 million (9M 2020: € 86.6 million). The R&D expenses increased due to higher development activity and the inclusion of expenses from the Constellation acquisition since July 15, 2021.

Selling, General and Administrative (SG&A) Expenses: Selling expenses increased in the first nine months of 2021 to € 89.0 million (9M 2020: € 75.0 million) and general and administrative (G&A) expenses amounted to € 60.1 million (9M 2020: € 37.2 million). The year-over-year increase in selling expenses was primarily driven by the commercialization activities for Monjuvi(R) in 2021 that were higher than during the ramp up of activities in 2020. The year-over-year increase in G&A expenses was driven primarily by the transaction costs related to the Constellation and Royalty Pharma agreements and the inclusion of Constellation’s G&A expenses.

Operating Loss: Operating loss amounted to € 183.3 million in the first nine months of 2021 (9M 2020: operating profit of € 93.1 million).

Consolidated Net Profit / Loss: For the first nine months of 2021, consolidated net loss was € 133.5 million (9M 2020: consolidated net profit of € 114.4 million).

Cash and Investments: As of September 30, 2021, the Company had cash and investments of € 1,130.9 million compared to € 1,244.0 million on December 31, 2020.

Number of shares: The number of shares issued totaled 34,231,943 at the end of Q3 2021 (year-end 2020: 32,890,046).

*Group revenues include full year Tremfya royalties and exclude any royalties from potential tafasitamab sales outside of the U.S. as well as any significant milestones from development partners and/or licensing partnerships other than those that were already recorded in the first 9-month period. This revenue guidance is subject to a number of uncertainties including the potential for variability from the first full year of the Monjuvi product launch, the limited visibility that MorphoSys has on the Tremfya royalty stream as well as the ongoing COVID-19 pandemic and the impact on our as well as our partner’s business operations.

**Operating expenses is comprised of R&D and SG&A, inclusive of Incyte’s share of Monjuvi selling costs in the U.S.

MorphoSys Group Key Figures (IFRS, September 30, 2021)

*Value as of December 31, 2020

MorphoSys will hold its conference call and webcast tomorrow, November 11, 2021, to present the results for the third quarter and first nine months of 2021 and the further outlook for 2021.

A live webcast and slides will be made available at the Investors section under "Presentations and Conferences" on MorphoSys’ website at View Source and after the call, a slide-synchronized audio replay of the conference will be available at the same location.

The statement for the third quarter/first nine months of 2021 (IFRS) is available online:
View Source/Reports

About Monjuvi(R) (tafasitamab)
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
In the United States, Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi(R) (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi(R) and Monjuvi(R) are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi(R) in the U.S., and marketed by Incyte under the brand name Minjuvi(R) in the EU.

XmAb(R) is a registered trademark of Xencor, Inc.

On November 10, 2021 Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue-based precision medicines, reported business highlights and financial results for the third quarter, ended Sept. 30, 2021 (Press release, Monte Rosa Therapeutics, NOV 10, 2021, View Source [SID1234595507]).

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"This year has been marked by several exciting and significant milestones for Monte Rosa, culminating in the naming of our first development candidate, MRT-2359, selectively targeting GSPT1 for the treatment of cancers driven by one of the Myc family genes," said Markus Warmuth, M.D., CEO of Monte Rosa. "Preclinical data recently presented at AACR (Free AACR Whitepaper)-NCI-EORTC underscores the potential of our molecular glue degraders to differentially induce cell death in Myc-addicted tumors. With the selection of MRT-2359 as our lead candidate, we are now positioned to rapidly advance our clinical development plan in both solid tumors and hematological malignancies. We have initiated IND-enabling studies and look forward to submitting our first IND to the FDA in mid-2022."

Owen Wallace, Ph.D., Chief Scientific Officer of Monte Rosa, added, "Advancing our first development candidate into IND-enabling activities is one of the most important milestones for our company to date. On a similar trajectory, our NEK7 degrader program has progressed into lead optimization, and we expect at least one additional program to move into lead optimization in 2021. In parallel, we continue to make important progress in the development of our unique and proprietary QuEEN platform and compound library, bringing us closer to our goal of tackling the previously undruggable target protein universe and fostering a new generation of precision medicine therapeutics."

THIRD QUARTER 2021 & RECENT HIGHLIGHTS

Selected first development candidate, MRT-2359, targeting GSPT1 and initiated IND-enabling activities. The company’s lead program targets GSPT1 for the treatment of cancers driven by one of the Myc family genes (c-Myc, N-Myc and L-Myc). The Myc transcription factors are some of the most frequently activated oncogenes in human cancers. Myc-driven cancer cells are highly addicted to protein translation. Because of the key role of GSPT1 in protein synthesis, GSPT1 degradation leads to apoptosis preferentially in these cells. MRT-2359 is a potent, selective and orally bioavailable GSPT1-directed molecular glue degrader in vitro and in vivo. MRT-2359 has been shown to induce tumor regression in multiple Myc-driven preclinical models of non-small cell lung cancer, small cell lung cancer and multiple myeloma.
Presented preclinical data highlighting potential of molecular glue degraders for the treatment of Myc-driven cancers. The data, selected for a late-breaking poster presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), demonstrate a novel link between GSPT1 and Myc-induced transcription and protein translation.
Presented at 4th Annual Targeted Protein Degradation Summit. The presentation, titled, "Molecular Glue Degraders: From Serendipity to Rational Design," showcased the capabilities of Monte Rosa’s QuEEN (Quantitative and Engineered Elimination of Neosubstrates) platform and its impact on expanding target space.
Presented at the BioData World Congress. The invited presentation showcased Monte Rosa’s artificial intelligence platform and the company’s pioneering work in AI and structural biology to identify molecular glue neosubstrates.
Added to the Russell 2000 and Russell 3000 Indexes as part of second quarter initial public offering additions, effective Sept. 20, 2021.

UPCOMING MILESTONES + EVENTS

Submit Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MRT-2359 in mid-2022.
Continue lead optimization for NEK7 and advance at least one additional program into lead optimization in 2021.
Progress proprietary programs beyond GSPT1 and NEK7, including CDK2, VAV1, BCL11A and additional undisclosed targets.
Present at upcoming investor conferences, including:
33rd Annual Piper Sandler Virtual Healthcare Conference, Nov. 30-Dec. 2, 2021
40th Annual J.P. Morgan Healthcare Conference, Jan. 9-13, 2022
THIRD QUARTER 2021 FINANCIAL RESULTS

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2021 were $15.1 million, compared to $5.5 million for the third quarter of 2020. The increase in R&D expense was primarily due to the expansion of research and development activities, including the advancement of development candidate MRT-2359, increased headcount and facilities in the United States and Switzerland, as well as corresponding increases in laboratory-related expenses.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2021 were $4.8 million, compared to $0.9 million for the third quarter of 2020. The increase in G&A expenses were a result of increased headcount and expenses in support of the company’s growth and operations as a public company.

Net Loss: Net loss for the third quarter of 2021 was $19.8 million, compared to $6.6 million for the third quarter of 2020.

Cash Position and Financial Guidance: Cash and cash equivalents as of Sept. 30, 2021, were $367.0 million, compared to $41.7 million as of December 31, 2020. The company expects its cash and cash equivalents, including the aggregate net proceeds from the initial public offering, will be sufficient to fund planned operations and capital expenditures into late 2024.

On November 10, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported that it will take part in two fireside chats, the first at the Stifel Healthcare Conference 2021, November 15-17, and the second at the Jefferies London Healthcare Conference, November 16-19. Both conferences will be held virtually (Press release, Cue Biopharma, NOV 10, 2021, View Source [SID1234608268]).

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During the fireside chats, Cue Biopharma will provide an updated corporate overview and recent data highlighting its lead clinical program, CUE-101, representative of the IL-2 based CUE-100 series, as a monotherapy and in combination with KEYRUDA (pembrolizumab) for the treatment of patients with HPV+ recurrent/metastatic head and neck cancer. The discussion will also focus on the Company’s CUE-100 series pipeline progress with drug product candidates CUE-102, targeting Wilms’ Tumor 1 (WT1) and CUE-103, targeting KRAS G12V, as well as its most recent Neo-STAT platform developments.

Presentation Details:

Stifel Healthcare Conference
Date and Time: Monday, November 15, 2:40 p.m. – 3:10 p.m. EST
Webcast link: View Source

A live and archived webcast of the fireside chat will be available on the Events page in the Investor and Media section of the Company’s website at www.cuebiopharma.com. The webcast will be archived for 30 days.

Jefferies Virtual London Healthcare Conference
Date and Time: The pre-recorded fireside chat will be available to conference attendees on-demand between 8:00 a.m. GMT/3:00 a.m. EST on Thursday, November 18 through 5:00 p.m. GMT/12:00 p.m. on Friday, November 19.

A replay of the fireside chat will be hosted on the conference website and available to attendees for 30 days after the event. For more information, email [email protected].

Also, an archived webcast of the fireside chat will be available after the conference on the Events page in the Investor and Media section of the Company’s website at www.cuebiopharma.com. The webcast will be archived for 30 days.

On November 10, 2021 Excyte Biopharma reported its bispecific antibody YK012 (acceptance number: CXSL2200041) was officially approved by the Drug Evaluation Center of the State Drug Administration (Press release, Excyte Biopharma, NOV 10, 2021, View Source;lang=en [SID1234646274]). YK012 is an innovative bispecific antibody targeting CD3/CD19 for the treatment of recurrent/refractory B-cell non-Hodgkin lymphoma.

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The approval of IND this time marks the transition from research and development to clinical use of new drugs with bispecific antibody of Yike Si Te, and is an important milestone in the research and development pipeline of Yike Si Te new drugs.

YK012, a bispecific antibody targeted at CD3 and CD19, is a Class I innovative drug, which is developed based on the quality by design concept of innovative immune double antibody design and the FIST platform with unique advantages and characteristics of YK012. It is positioned as the best in class.

The preclinical study data of YK012 of Ekester showed that its safety and effectiveness were significantly better than the marketed product Blincyto: at the cytological level, YK012 differentiated between effector cells and target cells; T cells are crosslinked and activated when and only when target cells exist; The level of full-spectrum CRS cytokines (including IL-6, IL-2, etc.) released by induction was significantly lower than that of Blincyto; The half-life of the monkey is more than 200 hours, more than 100 times that of Blincyto. Compared with Blincyto’s continuous intravenous infusion for 24 hours, YK012 will be injected intravenously once every two weeks, greatly improving the convenience and compliance of patients. In addition, Yikester YK012 has achieved the expression yield above gram level, and the preparation process is simple and efficient, laying a good foundation for the follow-up industrialization.

Co-founder of Ecotech CEO Yuan Qing’an said, "Ecotech is committed to developing products with global commercial value and functional superiority. At present, the main obstacle to developing CD3 bispecific antibodies that mobilize T cells to kill tumor cells is the severe cytokine storm (CRS) The clinical safety problems caused. In response to this pain point, Ecotech has designed the FIST platform, which has significantly reduced the CRS level of such products through a variety of ways, and has significantly increased the half-life and yield. It has the characteristics of high efficiency, high yield, low toxicity, and ease of use. It is a new generation of products in the field of CD3 dual antibody.

YK012 is a new targeted drug developed by us for acute leukemia (ALL), non-Hodgkin’s lymphoma (NHL) and other B-cell dysplasia diseases, with the same mechanism as CAR-T. The data of preclinical pharmacodynamics model showed that YK012 had better efficacy than Blincyto while greatly improving the safety. It was only two months from the submission of the application to the approval of the product, which proved the adequacy and effectiveness of the pre-clinical research data and laid a solid foundation for the clinical trial. Therefore, for the promotion of YK012 clinical trial, we are full of expectations and actively explore the development of new indications.

Based on the FIST platform, EKST also develops other new products that are urgently needed in clinic‘ In order to be better and different, it is the purpose of developing each variety to be a good medicine that people can afford. We hope to benefit more patients through our efforts.