Greenwich LifeSciences to Participate in Jefferies’ 12th Annual London Healthcare Conference

On November 17, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported CEO Snehal Patel will participate in the virtual portion of Jefferies’ Annual London Healthcare Conference held from November 16-19, 2021 (Press release, Greenwich LifeSciences, NOV 17, 2021, View Source [SID1234595727]).

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Jefferies’ Annual London Healthcare Conference

Jefferies’ 12th Annual London Healthcare Conference is the largest healthcare-dedicated conference in Europe. Participation is by invitation only and will feature leading public and private companies from the pharmaceuticals, biotechnology, medical technology, and healthcare services sectors from the Americas, Europe, Middle East, Africa, Asia, and Australia. For more information please visit: Jefferies London Healthcare Conference

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

Redx to Present at Jefferies London Healthcare Conference

On November 17, 2021 Redx Pharma (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, announces that Lisa Anson, Chief Executive Officer, reported that it will be presenting at the Jefferies London Healthcare Conference today, Wednesday 17 November at 08:40am GMT (Press release, Redx Pharma, NOV 17, 2021, View Source [SID1234595726]).

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The webcast can be accessed here: View Source

Atea Announces Update on Collaboration with Roche for AT-527

On November 17, 2021 Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) ("Atea"), a clinical-stage biopharmaceutical company, reported that the strategic collaboration pursuant to which it was jointly developing AT-527 for the treatment of COVID-19 with Roche will be terminating (Press release, Chugai, NOV 17, 2021, View Source [SID1234595725]). Upon termination, the rights and licenses granted by Atea to Roche under the strategic collaboration will be returned to Atea, and Atea will have full rights to continue the clinical development and future commercialization of AT-527 worldwide.

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"We believe strongly in the potential of AT-527 with its unique dual mechanism of action, antiviral activity against the major variants of concern and its market potential given the need for additional therapeutic options for COVID-19," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "We have the financial resources and the talent to independently drive forward the Phase 3 MORNINGSKY clinical trial program, and we continue to expect data from this trial during the second half of 2022. We are energized by the opportunity to move forward with full ownership, providing us with autonomy to efficiently bring AT-527 to market."

The strategic collaboration with Roche, which included joint development, will be terminated on February 10, 2022.

"We are continuing to expedite efforts to submit the recently announced Phase 3 MORNINGSKY amendment to global health authorities," said Janet Hammond, MD, PhD, Chief Development Officer of Atea Pharmaceuticals. "We have an established development team at Atea with extensive global clinical trial experience, as well as outside resources we continue to leverage. We remain committed to developing and delivering AT-527 as an oral antiviral that will address treatment needs for patients as COVID-19 continues to evolve."

As of September 30, 2021, Atea reported cash and cash equivalents of $839.7 million with a cash runway through 2023.

About the AT-527 COVID-19 Clinical Development Program

Derived from Atea’s nucleos(t)ide prodrug platform, AT-527 is an oral direct-acting antiviral which is being studied to determine its potential to protect against disease progression and the development of long-COVID complications. Its unique mechanism of action, with dual targets including chain termination (RdRp) and NiRAN inhibition, has the potential to create a high barrier to resistance with broad antiviral coverage to different variants of SARS-CoV-2. Atea has completed a comprehensive nonclinical program to characterize the safety profile of AT-527. Results observed from these nonclinical studies demonstrated that AT-527 was non-mutagenic, had no effects on fertility or reproduction and was non-teratogenic.

Atea is evaluating AT-527 across multiple clinical trials that are advancing in parallel, including the global Phase 3 MORNINGSKY trial.

Summary of Consolidated Financial Results [Japanese GAAP] For the Second Quarter of the Fiscal Year Ending March 31, 2022

On November 17, 2021 Nippon Kayaku reported that Results for the Second Quarter of the Fiscal Year Ending March 31, 2022 (Press release, Nippon Kayaku, NOV 17, 2021, View Source [SID1234595724])

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

2. Status of Dividends
3. Consolidated Business Results Forecasts for the Fiscal Year Ending March 31, 2022 (April 1, 2021– March 31, 2022)

1. Qualitative Information Concerning Results for the Second Quarter
(1) Analysis of Operating Results During the first half of this consolidated fiscal year (April 1 to September 30, 2021), the global economy saw economic activity begin to return to normal and signs of economic recovery, due in part to progress on vaccinations for the novel coronavirus (COVID-19). While the recovery of the Japanese economy is lagging compared to Europe and the U.S., business sentiment has improved. However, the impacts of the semiconductor shortage and the automobile industry production cuts due to difficulty of procuring parts accompanying the spread of COVID-19 in Southeast Asia were exacerbated in Japan and overseas, particularly in the second quarter of this consolidated fiscal year.

Concerns over deceleration of the Chinese economy also remain. Amid these conditions, the Nippon Kayaku Group worked to implement the key themes and resolve the midand long-term key issues outlined in "KAYAKU Next Stage," the mid-term business plan launched in the fiscal year ended March 31, 2020, while also making active use of staggered working hours, telecommuting, and other systems amid the restrictions imposed on corporate activities. We took these steps to ensure the safety of employees working in the Company and at Group companies while also implementing a new lifestyle and promote efficient workstyles aimed at minimizing the impact on our business. As a result, net sales for the first half of this consolidated fiscal year totaled 88,840 million yen, an increase of 8,321 million yen (10.3%) year-on-year. Sales in all of the businesses outperformed the first half of the previous fiscal year.

Operating income totaled 10,902 million yen, an increase of 3,925 million yen (56.3%) year-on-year. Ordinary income totaled 11,828 million yen, an increase of 4,487 million yen (61.1%) year-on-year. Profit attributable to owners of parent was 9,205 million yen, an increase of 4,322 million yen (88.5%) year-on-year. Regarding changes in accounting policies, the Company implemented the Accounting Standard for Revenue Recognition (ASBJ Statement No. 29, revised March 31, 2020) and other guidance from the beginning of the first quarter of this consolidated fiscal year. We have therefore used numbers based on calculation methods subject to different standards than in the same period of the previous fiscal year. See

2. Quarterly Consolidated Financial Statements and Notes to Quarterly Consolidated Financial Statements,
(4) Notes to Quarterly Consolidated Financial Statements (Changes to Accounting Policies) for further details. Performance by business segment is as described below. [Functional Chemicals Business] Sales stood at 37,612 million yen, an increase of 2,762 million yen (7.9%) year-on-year. The Functional Materials Business as a whole outperformed the first half of the previous fiscal year. The outperformance resulted from strong sales of epoxy resins used in semiconductor encapsulation, circuit boards, and LCD cleaners from increased demand for IT equipment due to telecommuting, in addition to the proliferation of high-speed (5G) communications devices and IoT, and the increasingly sophisticated electronic equipment in vehicles. The Color Materials Business as a whole outperformed the first half of the previous fiscal year.

This outperformance was due to a rebound in demand for colorants for inkjet printers in industrial applications, in addition to strong sales of colorants for inkjet printers for consumer use. The Catalyst Business underperformed the first half of the previous fiscal year because of the lull between customer replacement periods. In the Polatechno Business, a rebound in demand for polarizing films for LCD projectors and dye-type polarizing films, in addition to strong sales of components for X-ray analysis systems resulted in outperformance of the Polatechno Business as a whole, compared with the first half of the previous fiscal year. Segment profit totaled 6,074 million yen, an increase of 2,427 million yen (66.6%) year-on-year. This increase resulted from growth in net sales in each business. [Pharmaceuticals Business] Sales stood at 25,534 million yen, an increase of 400 million yen (1.6%) year-on-year. Pharmaceuticals in Japan underperformed the first half of the previous fiscal year due to the impact from drug price revisions, despite market penetration of PORTRAZZA, a biomedicine; the switch to antibody biosimilars, TRASTUZUMAB BS and INFLIXIMAB BS; growth in sales of a cancer-related generic, APREPITANT capsule; and the launch of the new generic anti-cancer drug PEMETREXED in July. Sales of active pharmaceutical ingredients for the Japanese domestic market underperformed while exports, and sales of contract production and diagnostic drugs outperformed the same period of the previous fiscal year. Segment profit totaled 4,115 million yen, a decrease of 218 million yen (5.0%) year-on-year.

This resulted from the impact of drug price revisions, in addition to increased expenses related to sales activities adjusted to the new life style and progress on R&D activities.

Financial Results for the Second Quarter
of the Fiscal Year Ending March 31, 2022
(FY2022 1H)

ON November 17, 2021 Nippon Kayaku reported that Financial Results for the Second Quarter of the Fiscal Year Ending March 31, 2022 (FY2022 1H) FY2022 : 1H (Press release, Nippon Kayaku, NOV 17, 2021, View Source [SID1234595723])

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Topics (1) Net sales and income increase year-on-year; revised full-year business forecasts Net sales of 97%, operating income by industry segment of 107%, operating income of 111%, and profit attributable to owners of parent of 115% compared with forecasts for the first half of FY 2022 (announced on July 30, 2021)

・ Gross profit increased due to robust sales of Functional Chemicals business and others and cost reductions stemming from an increased capacity utilization rate
・ Although a 2Q impact was observed in the Safety Systems business and other areas due to a slowdown in automobile production affected by a semiconductor shortage, performance as a whole was solid in the first half
・ Profits increased due to controlled selling, general and administrative expenses. Acquisition of Treasury Stock (May to September)
・ 2.63 million shares (approx. 3.0bn yen)
・ 1.54% of the total number of issued shares excluding treasury stock Summary of Nippon Kayaku Group 5 FY2022 : 1H Topics

(2) Functional Chemicals Business Functional Materials
• Continued strong sales of semiconductor-related epoxy resins, such as for circuit boards and encapsulations
• In UV-curable resins, strong sales of materials for resists and display products
• Strong sales of cleaners for LCDs, semiconductors and electronic components Color Materials
• Continued strong demand for consumer inkjet printer colorants
• Good performance of industrial inkjet inks due to recoveries in printing demand and capital investment. Favorable sales of textile inkjet dyes due to market recovery

• Developers for thermal paper and dyes improved in the first half, but are still mid-recovery Catalyst
• Sales higher than expected due to orders received ahead of schedule Polatechno
• Optical Films business showed signs of recovery, particularly for automotive applications, but declined in 2Q under the impact of a decrease in production caused by a shortage of ICs
• Precision Components business is solid based on recovery in projector demand; X-ray analyzer components are strong 6 FY2022 : 1H Topics

(3) Pharmaceuticals Business
• Introduced ALAGLIOⓇ, a photodynamic diagnostics agent, acquired marketing rights, and commenced promotional activities
• PORTRAZZAⓇ, a new biomedicine for lung cancer treatment, achieved market penetration
• Biosimilars: INFLIXIMAB BS and TRASTUZUMAB BS grew
• Launched generic anti-cancer drug: PEMETREXED, metabolic malignancies
• Approved FOSAPREPITANT, antiemetic agent Safety Systems Business
• Decrease in sales stemming from a slowdown in automobile production in response to the worldwide semiconductor shortage
• Customer orders of local subsidiaries ceasing operations under lockdown in Malaysia have been covered within the Group Agrochemicals and Other Businesses
• In the agrochemicals business, domestic sales of the soil fumigants, TERONTM and ASAHI D-D were firm
• Sluggish overseas due to difficulties in procuring raw materials