On November 10, 2021 Kureha Corporation reported that (Press release, Kureha Corporation, NOV 10, 2021, View Source [SID1234595215])

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1. Consolidated Financial Results for the Second Quarter of the Fiscal Year Ending March 31, 2022 (From April 1, 2021 to September 30, 2021)
(1) Consolidated Operating Results
(2) Consolidated Financial Position

2. Dividends
2. Consolidated Earnings Forecast for the Fiscal Year Ending March 31, 2022 (From April 1, 2021 to March 31, 2022)

1. Advanced Materials In the advanced plastics category, revenue and operating profit rose on higher sales of polyvinylidene fluoride (PVDF) used as a binder material for lithium-ion secondary batteries, polyglycolic acid (PGA) products used in the process of shale oil and gas fracking, polyphenylene sulfide (PPS), and other processed plastics products. In the carbon products category, revenue rose on higher sales of carbon fiber used in heat insulating material for high-temperature furnaces and sliding material for automotive parts, but operating profit was flat year on year. As a result, revenue in Advanced Materials was 28,794 million yen (up 54.9% year on year), and operating profit was 2,600 million yen (versus operating loss of 760 million yen in the six months ended September 30, 2020).

2. Specialty Chemicals Revenue increased in the agrochemicals and pharmaceuticals category owing to higher sales of Kremezin (therapeutic agent for chronic renal failure) as well as agricultural and horticultural fungicides. However, operating profit was flat year on year. In the industrial chemicals category, revenue rose due to higher sales of organic chemicals, and earnings recovered to an operating profit from an operating loss recorded in the same period the previous year. Consequently, revenue in Specialty Chemicals was 12,804 million yen (up 15.7% year on year), resulting in an operating profit of 1,168 million yen (up 32.3% year on year).

3. Specialty Plastics Both revenue and operating profit increased in the consumer goods category as sales of New Krewrap plastic wrap for household use and Seaguar fluorocarbon fishing lines increased. In the packaging materials category, revenue and operating profit also increased due to higher sales of polyvinylidene chloride (PVDC) film and heat-shrink multilayer film. As a result, revenue in Specialty Plastics was 22,942 million yen (up 8.8% year on year), and operating profit was 5,140 million yen (up 38.1% year on year).

4. Construction In Construction, private-sector construction projects were on par with the previous year, but delays of public-sector construction starts caused both revenue and operating profit to decline year on year. Consequently, revenue in Construction was 5,524 million yen (down 5.2% year on year), and operating profit was 414 million yen (down 10.5% year on year).

5. Other Operations In the environmental engineering category, despite higher volumes of industrial waste treatment and processing including low-concentration PCB waste, revenue and operating profit declined on the completion of the natural disaster-related waste treatment and processing conducted during the same period the previous year. In the logistics category, both revenue and operating profit remained flat year on year. In the hospital operations category, both revenue and operating loss remained flat year on year. As a result, revenue in Other Operations was 9,003 million yen (down 4.9% year on year), and operating profit was 1,799 million yen (down 10.2% year on year).

(2) Overview of Financial Position for the Period under Review Total assets as of September 30, 2021 were 264,557 million yen, up 7,634 million yen compared to March 31, 2021. Current assets totaled 91,804 million yen, up 5,567 million yen from March 31, 2021, due to increases in cash and cash equivalents and trade receivables. Non-current assets stood at 172,752 million yen, up 2,066 million yen from March 31, 2021. Contributing factors to the rise in non-current assets were increases in the valuation of investment securities, intangible assets, assets related to equity method investments, and retirement benefit asset, which offset the 2,280 million yen decline in property, plant and equipment to 117,891 million yen from the reduction entry accompanying receipt of government subsidy. Total liabilities were 70,859 million yen, down 542 million yen compared to March 31, 2021. This primarily reflects the repayment of loans payable, which minimized the interest-bearing debt by 2,042 million yen to 27,464 million yen, more than absorbing the increase in trade payables. Total equity was 193,698 million yen, up 8,176 million yen compared to March 31, 2021. This was mainly due to the recording of 8,328 million yen in profit attributable to owners of the Company and an increase in other components of equity, which offset the dividend payments of 1,659 million yen from retained earnings. As of September 30, 2021, the COVID-19 pandemic has had no impact on the Group’s capacity to secure liquidity or collect accounts receivable.

(3) Outlook for the Fiscal Year Ending March 2022 and beyond In light of recent performance trends, the Company has revised its consolidated earnings forecast for the fiscal year ending March 31, 2022 from the figures announced on May 12, 2021. For details, please refer to the "Notice of Revised Financial Forecast and Revised Dividend Forecast" released today (November 9, 2021)

On November 10, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results for the third quarter 2021 (Press release, Cyclacel, NOV 10, 2021, View Source [SID1234595232]). The quarter’s business highlights include an update on the Company’s progress with fadraciclib and CYC140, Cyclacel’s novel CDK2/9 and PLK1 inhibitors, respectively.

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"The Cyclacel team continued to execute on our plan during the quarter with the opening of two Phase 1/2 studies for oral fadraciclib and filing an IND for a Phase 1/2 study of our oral PLK1 inhibitor, CYC140," said Spiro Rombotis, President and Chief Executive Officer. "We have now enrolled a total of six patients across two dosing levels in our fadraciclib study in solid tumors and have started the first dose level in the fadraciclib study in leukemia. We are pleased with the strong investigator interest in our studies as we build a global network of participating institutions for our clinical studies and preclinical collaborations.

We are also looking forward to the near future with the planned initiation of two registration-enabling Phase 1/2 studies of CYC140 in patients with solid tumors and leukemias and reporting initial data for fadraciclib in solid tumors. We remain diligently focused on bringing innovative treatment options to cancer patients with unmet medical needs and realizing the promise of our pipeline."

Key Corporate Highlights

Oral fadraciclib program

·Six patients with advanced solid tumors treated in the first two dosing levels of 065-101, Phase 1/2, registration-directed study
·Two additional internationally-recognized cancer treatment centers added to 065-101 selected for their expertise with tumor types of interest; for a total of four sites
·First patient dosed in the 065-102, Phase 1/2, registration-directed study in patients with leukemia
·Multiple preclinical studies in progress which will inform fadraciclib’s clinical development

Oral CYC140 program

·Filed with FDA an IND for a streamlined, registration-directed, Phase 1/2 study of orally-available CYC140 in solid tumors
·Initial data in preclinical models show that KRAS mutant cancers are sensitive to oral CYC140 inhibition
·Preclinical collaborative studies ongoing to support selection of histologies to be included in the Phase 1/2 study

Key Near-Term Business Objectives

·FDA clearance of IND filing and initiation of oral CYC140 Phase 1/2 advanced solid tumor study
·Initial data from first part of 065-101 study with oral fadraciclib in advanced solid tumors
·First patient to be dosed with oral CYC140 in Phase 1/2 leukemia study
·Initial data from first part of 065-102 study with oral fadraciclib in leukemia

Financial Highlights

As of September 30, 2021, cash and cash equivalents totaled $40.2 million, compared to $43.6 million as of June 30, 2021. The decrease of $3.4 million was primarily due to $6.3 million net cash used in operating activities, offset by $2.9 million cash provided by financing activities. The Company estimates that available cash resources will fund currently-planned programs through early 2023.

Research and development (R&D) expenses were $4.2 million for the three months ended September 30, 2021 as compared to $1.1 million for the same period in 2020. R&D expenses relating to fadraciclib increased by approximately $2.5 million for the three months ended September 30, 2021 due to clinical supply manufacturing and opening of clinical trial sites for the evaluation of fadraciclib in Phase 1/2 studies. Additionally, R&D expenses related to CYC140 increased $0.5 million for the quarter as preclinical evaluation and clinical trial supply manufacturing of CYC140 progressed.eneral and administrative expenses for the three months ended September 30, 2021 were $1.8 million, compared to $1.5 million for the same period of the previous year due to increased legal, professional and recruitment costs relating to expansion of the clinical team.

United Kingdom research & development tax credits were $1.0 million for the three months ended September 30, 2021, as compared to $0.3 million for the same period in 2020 due to the increase in R&D expenditure.

Net loss for the three months ended September 30, 2021 was $5.0 million, compared to $2.3 million for the same period in 2020.

On November 10, 2021 AbbVie (NYSE: ABBV) reported that it will participate in the Wolfe Research Healthcare Conference on Wednesday, November 17, 2021 (Press release, AbbVie, NOV 10, 2021, View Source [SID1234595065]). Michael Severino, M.D., vice chairman and president, Robert A. Michael, executive vice president and chief financial officer, and Jeffrey R. Stewart, executive vice president, commercial operations, will present at 8:30 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On November 10, 2021 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers, reported that Thomas Butler, Chief Executive Officer and Chairman of the Board, will participate in two upcoming virtual conferences (Press release, Biomea Fusion, NOV 10, 2021, View Source [SID1234595081]).

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Jefferies London Healthcare Conference
Fireside chat on Thursday, November 18th at 3:00am ET

Piper Sandler 33rd Annual Virtual Healthcare Conference
Fireside chat on Monday, November 22nd at 10:00am ET

Biomea Fusion will participate in 1×1 investor meetings during the conferences hosted by Jefferies and Piper Sandler, respectively. Video webcasts will be available for viewing on the News & Events section of biomeafusion.com. Archived webcasts will be available for viewing for 30 and 90 days, respectively, following the webcasts.

About BMF-219

BMF-219 is an irreversibly binding inhibitor of menin, a protein that is known to play an essential role in oncogenic signaling in genetically defined leukemias. Preclinically, BMF-219 has demonstrated robust downregulation of key leukemogenic genes in addition to menin itself (via MEN1) in well-established menin dependent cell lines. Additionally, BMF-219 has shown efficacy in multiple in vivo and in vitro models of acute leukemias and lymphomas. BMF-219 will be evaluated in a first-in-human trial in patients with relapsed or refractory acute leukemia with MLL/KMT2A gene rearrangement or NPM1 mutation.

On November 10, 2021 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the third quarter ended September 30, 2021 (Press release, CymaBay Therapeutics, NOV 10, 2021, View Source [SID1234595097]).

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Sujal Shah, President and CEO of CymaBay, stated, "The third quarter of 2021 included key accomplishments that position CymaBay for long-term success. The non-dilutive, risk-sharing development financing agreement signed with Abingworth in July supports the completion of our ongoing phase 3 program for seladelpar in PBC. We now have over 100 sites activated across over 20 countries in our global registration study, RESPONSE, and expect these efforts to continue and ultimately drive the completion of enrollment in the first half of 2022. We are excited to also share additional data from our prior studies in PBC at The Liver Meeting 2021 that demonstrate improved benefit of seladelpar between one to two years of treatment and differentiation from other existing treatments in a population of patients with more advanced disease."

"As we approach the end of 2021, we are well positioned to deliver on our central focus of improving the lives of patients with PBC. Although the pandemic has presented our entire industry with evolving challenges, I am confident we have assembled talent across the organization that will allow us to achieve both our near term goals and our vision of establishing a pipeline of opportunities for patients with unmet need. I’m also proud of the relationships we have established with patient communities, the medical community and high quality investors that all support the work we are dedicated to day in and day out."

Upcoming and Recent Corporate Highlights

An oral presentation titled "Long-Term Safety and Efficacy of Seladelpar in Patients with Primary Biliary Cholangitis" will be delivered by Dr. Marlyn J. Mayo, MD, Professor and Liver Disease Specialist, University of Texas Southwestern Medical Center. This presentation will highlight the efficacy and safety of seladelpar during 2 years of treatment in patients with primary biliary cholangitis (PBC). The mean percent change in alkaline phosphatase (ALP) from baseline was -42% and -50% after 1 and 2 years, respectively. Over 2 years, there were sustained reductions in ALT, AST, and GGT. Total bilirubin and platelet levels remained stable. Seladelpar appeared safe and well-tolerated. These data support that long-term treatment with seladelpar resulted in continued improvement in markers of cholestasis after 1 year.
A clinical presentation titled "Efficacy and Safety of Seladelpar in Patients with Compensated Cirrhosis and Evidence of Portal Hypertension due to Primary Biliary Cholangitis" will be delivered by Dr. Cynthia Levy, MD, Professor of Medicine, University of Miami. This electronic poster presentation will highlight the treatment effects of seladelpar in compensated cirrhotic patients with portal hypertension after 3 months, which led to ALP changes of -30% in the 5 mg and -45% in the 10 mg groups. Total bilirubin, platelets, albumin, and INR either improved or remained stable. Seladelpar appeared safe and well-tolerated. Efficacy, safety, and tolerability in patients with compensated cirrhosis and portal hypertension was comparable to that of non-cirrhotic patients.
CymaBay will host a Post-AASLD KOL Call on seladelpar in PBC on Monday, November 15, at 4:30pm ET. The webinar will feature presentations by Dr. Marlyn J. Mayo, MD, and Dr. Cynthia Levy, MD, who will be reviewing the seladelpar abstracts presented at The Liver Meeting 2021. Dr. Dennis Kim, MD, Chief Medical Officer of CymaBay, will also discuss progress developing seladelpar for patients with PBC. The live and archived webcast will be accessible through this webcast link or through the Events section of the CymaBay website.
Continued enrollment in RESPONSE, a 52-week, placebo-controlled, randomized, global, Phase 3 registrational study evaluating the safety and efficacy of seladelpar in patients with PBC. This study is targeting enrollment of 180 patients who have an inadequate response to, or intolerance to, ursodeoxycholic acid, in a 2:1 randomization to oral, once daily seladelpar 10 mg or placebo. The primary outcome measure is the responder rate at 52 weeks. A responder is defined as a patient who achieves an alkaline phosphatase level < 1.67 times the upper limit of normal with at least a 15% decrease from baseline and has a normal level of total bilirubin. Additional key outcomes of efficacy will compare the rate of normalization of alkaline phosphatase at 52 weeks and the level of pruritus at 6-months for patients with moderate to severe pruritus at baseline assessed by a numerical rating scale recorded with an electronic diary.
Continued enrollment in ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional long-term safety data to support registration.
Supported enrollment efforts in a Phase 2a proof-of-pharmacology study to evaluate the potential for MBX-2982, a GPR119 agonist, to prevent hypoglycemia in patients with type 1 diabetes. The study is being conducted by the AdventHealth Translational Research Institute in Orlando, Florida and fully funded by The Leona M. and Harry B. Helmsley Charitable Trust with CymaBay retaining full rights to MBX-2982.
Executed a non-dilutive financing transaction with Abingworth LLP for the development of seladelpar in PBC. Under the terms of the agreement, CymaBay will receive up to $100 million of funding for seladelpar development costs, of which $75 million will be received in three installments over approximately six months. The first installment of $25 million was received in August and the second installment of $25 million was received in early November. CymaBay expects to receive the third $25 million installment in early February 2022 and has an option to receive an additional $25 million within approximately two months of the completion of enrollment of CymaBay’s Phase 3 RESPONSE clinical trial.
Held $113.8 million in cash, cash equivalents and short-term investments as of September 30, 2021. We believe that cash and investments on hand, together with additional funding amounts we expect to receive through the development financing agreement with Abingworth are sufficient to fund CymaBay’s operating plan into 2023.
Due to the ongoing effects of the global coronavirus pandemic, CymaBay continues to conduct its operations remotely for all employees, which has allowed business activities to continue as seamlessly as possible. The recent emergence of the Delta variant and other variants has led to uncertainty regarding the duration and effects that the pandemic will have on future operating milestones. CymaBay continues to closely monitor pandemic developments and their associated risks to the business, including the conduct of its clinical development of seladelpar, and will continue to take actions to mitigate them where possible. Further, all CymaBay’s actions will continue to be guided by a commitment to ensuring the health and safety of its employees as well as patients enrolled in its clinical studies.
Third Quarter and Nine Months Ended September 30, 2021 Financial Results

Research and development expenses for the three months ended September 30, 2021 and 2020 were $17.0 million and $7.7 million, respectively. Research and development expenses for the nine months ended September 30, 2021 and 2020 were $46.1 million and $25.2 million, respectively. Research and development expenses in the three and nine months ended September 30, 2021 were higher than the corresponding periods in 2020 primarily due to an increase in clinical trial activities associated with the development of seladelpar in PBC. In particular, cost increases were primarily driven by an expansion of our site activation, patient enrollment, and other clinical trial activities associated with RESPONSE and ASSURE, our two active global late-stage clinical trials in PBC. In the three and nine months ended September 30, 2020, costs incurred were primarily associated with startup activities for RESPONSE and ASSURE as well as costs to shutdown our Phase 3 PBC, Phase 2b NASH, and Phase 2 PSC clinical trials, and other studies, after the seladelpar development program was placed on hold from November 2019 through July 2020.

General and administrative expenses for the three months ended September 30, 2021 and 2020 were $5.2 million and $3.9 million, respectively. General and administrative expenses for the nine months ended September 30, 2021 and 2020 were $16.9 million and $11.5 million, respectively. General and administrative expenses in the three and nine months ended September 30, 2021 were higher than the corresponding periods in 2020 due to higher employee compensation associated with the hiring of additional personnel and an increase in consulting and other expenses upon resumption of development of seladelpar in the second half of 2020. In addition, general and administrative expenses during the three and nine months ended September 30, 2020, included restructuring charges of $0.6 million and $0.7 million, respectively, and no similar restructuring charges were incurred during the three and nine months ended September 30, 2021.

Net loss for the three months ended September 30, 2021 and 2020 was $22.7 million and $11.4 million, or ($0.33) and ($0.17) per diluted share, respectively. Net loss for the nine months ended September 30, 2021 and 2020 was $63.5 million and $35.2 million, or ($0.92) and ($0.51) per diluted share, respectively. Net loss was higher largely due to increases in clinical operating expenses, which were incurred following the resumption of our clinical development of seladelpar in PBC during the second half of 2020. We expect our operating expenses to increase in the future as we continue to execute on our clinical development plans.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss third quarter 2021 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13723498. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source