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.

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.

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

On November 16, 2021 SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, reported an exclusive, target-specific license and option agreement with LegoChem Biosciences Inc., a biotechnology company focused on developing its clinical-stage platform technology enabling antibody-drug conjugates (ADCs) with an excellent therapeutic index (Press release, SOTIO, NOV 16, 2021, View Source [SID1234628156]). SOTIO will obtain rights to deploy LCB’s ADC technology for up to five therapeutic programs targeting distinct tumor-associated antigens.

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The deal enables SOTIO to combine its proprietary antibodies with LCB’s ADC technology platform in order to deliver novel therapeutics for the treatment of solid tumors and includes LCB’s proprietary conjugation technology ConjuAll and potent linker-payload platform including multiple different payloads.

Under the terms of the multi-target agreement, LCB is eligible to receive upfront and potential milestone payments worth up to $1027.5 million, payable based on certain developments and regulatory achievements, plus royalties on net sales. The deal includes upfront and near-term milestones worth up to $29.5 million, subject to exercise of the options and achievement of success-based milestones. No further financial details are disclosed.

"At SOTIO we are building an innovative pipeline of ADC programs and plan IND filing for our lead program SOT102 by the end of 2021. The licensing agreement with our new, experienced partner LegoChem allows us to broaden our oncology pipeline with additional programs and solid tumor targets. We are looking forward to using the potential of LegoChem’s ADC technology platform and to develop innovative ADCs for patients in need," said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO.

SOTIO will be responsible for research, development, manufacturing and commercialization of the ADC products, while LCB will support and work closely with SOTIO for the research activities and the manufacturing of components that are specifically related to its proprietary ConjuAll and the linker-payload technologies.

Dr. Yong-Zu Kim, CEO and President of LCB added: "This collaboration is yet another example that illustrates how the value proposition of the LCB platform can increase the competitive position of our partners within the ADC space. SOTIO is an ideal partner for LCB due to its expertise and strategic focus on innovative antibody drug conjugates, and we look forward to working closely together on multiple innovative programs."

On November 16, 2021 Apellis Pharmaceuticals, Inc., (Nasdaq:APLS), a global biopharmaceutical company and leader in complement, reported the pricing of its underwritten public offering of 8,750,000 shares of its common stock at a public offering price of $40.00 per share, for total gross proceeds of $350 million, before deducting underwriting discounts and commissions and expenses payable by Apellis (Press release, Apellis Pharmaceuticals, NOV 16, 2021, View Source [SID1234595729]). All of the shares in the offering are being sold by Apellis. In addition, Apellis has granted the underwriters a 30-day option to purchase up to 1,312,500 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on November 18, 2021, subject to customary closing conditions.

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering. Robert W. Baird & Co. Incorporated, Oppenheimer & Co. Inc. and Raymond James & Associates, Inc. are acting as lead managers for the offering.

The shares are being offered by Apellis pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on January 7, 2020. This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or Evercore Group L.L.C., Attention: ECM General Counsel, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.