On October 28, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported that it will report its third quarter 2020 financial and operating results on Wednesday, November 4, 2020, following the close of the U.S. financial markets (Press release, Lineage Cell Therapeutics, OCT 28, 2020, View Source [SID1234569212]). Lineage management will also host a conference call and webcast on Wednesday, November 4, 2020, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2020 financial and operating results and to provide a business update.

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Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through November 12, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 7780879.

On October 28, 2020 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that it will host a third quarter 2020 investor call on Wednesday, November 4, 2020 at 8:00 AM EST to discuss financial results and provide a corporate update (Press release, Pieris Pharmaceuticals, OCT 28, 2020, View Source [SID1234569211]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To access the call, participants may dial 877-407-8920 (Toll Free US & Canada) or 412-902-1010 (International) at least 10 minutes prior to the start of the call.

An archived replay of the call will be available for 30 days by dialing 877-660-6853 (Toll Free US & Canada) or 201-612-7415 (International) and providing the Conference ID #13661472.

On October 28, 2020 Seagen Inc. (Nasdaq: SGEN) reported the closing of a $1.0 billion equity investment by Merck in 5.0 million newly-issued shares of Seagen common stock at a price of $200 per share (Press release, Seagen, OCT 28, 2020, View Source [SID1234569210]). The closing occurred following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act). The investment was made in connection with a global collaboration with Merck to co-develop and commercialize ladiratuzumab vedotin, an investigational antibody-drug conjugate (ADC) targeting LIV-1, which is currently in clinical trials for breast cancer and other solid tumors.

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"This investment by Merck further strengthens our balance sheet, and provides us with considerable financial resources to continue building Seagen as a global, multi-product oncology company," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seagen. "We are investing in broad clinical development of our approved products, advancing our late-stage programs and conducting R&D to ensure a robust early-stage pipeline of innovative therapies for the treatment of cancer."

The financial impact of the collaboration, including the stock purchase agreement, will be discussed during Seagen’s third quarter financial results conference call on October 29, 2020.

Ladiratuzumab Vedotin Collaboration Details

Under the terms of the agreement, Seagen and Merck will collaborate and equally share costs on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs. The companies have agreed to jointly develop and share future costs and profits for ladiratuzumab vedotin on a 50:50 basis worldwide. Merck paid Seagen $600 million upfront and made a $1.0 billion equity investment in 5.0 million shares of Seagen common stock at a price of $200 per share in connection with entry into the agreement. In addition, Seagen will be eligible to receive up to $2.6 billion in milestone payments, including $850 million in development milestones and $1.75 billion in sales milestones.

The companies will jointly develop and commercialize ladiratuzumab vedotin and equally share profits worldwide. The companies will co-commercialize in the U.S. and Europe. Seagen will be responsible for marketing applications for approval in the U.S. and Canada, and will record sales in the U.S., Canada and Europe. Merck will be responsible for marketing applications for approval in countries outside the U.S. and Canada, and for sales efforts in countries outside the U.S., Europe and Canada. Including the upfront payment, equity investment proceeds and potential milestone payments, Seagen is eligible to receive up to $4.2 billion.

About Ladiratuzumab Vedotin

Ladiratuzumab vedotin is a novel investigational ADC targeted to LIV-1. Most metastatic breast cancers express LIV-1, which also has been detected in several other cancers, including lung, head and neck, esophageal and gastric. Ladiratuzumab vedotin utilizes Seagen’s proprietary ADC technology and consists of a LIV-1-targeted monoclonal antibody linked to a potent microtubule-disrupting agent, monomethyl auristatin E (MMAE) by a protease-cleavable linker. This novel ADC is designed to bind to LIV-1 on cancer cells and release the cell-killing agent into target cells upon internalization. Ladiratuzumab vedotin may also cause antitumor activity through other mechanisms, including activation of an immune response by induction of immunogenic cell death.

On October 28, 2020 Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, reported that it has commenced an underwritten public offering of up to $400,000,000 of shares of its common stock (Press release, Ultragenyx Pharmaceutical, OCT 28, 2020, View Source [SID1234569209]). In addition, the company is expected to grant the underwriters of the offering an option for a period of 30 days to purchase up to an additional $60,000,000 of shares of common stock at the public offering price, less the underwriting discount.

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The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed. J.P. Morgan, Goldman Sachs & Co. LLC, BofA Securities and Cowen are acting as joint book-running managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became automatically effective on February 21, 2018. This offering is being made solely by means of prospectus supplement and accompanying prospectus. When available, copies of the preliminary prospectus supplement and the accompanying prospectus related to the offering may be obtained from 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 prospectus- [email protected]; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; and Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, United States, Attn.: Prospectus Department or by telephone 1-631-274-2806.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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.

On October 28, 2020 GSK reported that resilient performance, strong commercial execution and further strategic progress in Q3 (Press release, GlaxoSmithKline, OCT 28, 2020, View Source [SID1234569208]).

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Financial and product highlights
Reported Group sales £8.6 billion, -8% AER, -3% CER (Pro-forma -5% CER*, -3% CER excluding divestments/brands under review). Pharmaceuticals £4.2 billion, -7% AER, -3% CER; Vaccines £2.0 billion, -12% AER, -9% CER; Consumer Healthcare £2.4 billion, -4% AER, +2% CER (Pro-forma -6% CER*). Strong performance from key growth drivers in respiratory, HIV, oncology and Consumer Healthcare partly offset by expected disruption from COVID-19
Sales of new and specialty pharmaceuticals (excluding established products) £2.5 billion, +8% AER, +12% CER
Respiratory sales £978 million, +21% AER, +26% CER. Trelegy sales £194 million +40% AER, +45% CER. Nucala sales £251 million, +24% AER, +29% CER
HIV sales £1.2 billion, -4% AER, flat at CER; two-drug regimen sales £222 million, +87% AER, +94% CER
Oncology sales £99 million, +55% AER, +58% CER
Shingrix sales £374 million, -30% AER, -25% CER. US prescriptions rates returned to 2019 levels by quarter-end
Total Group operating margin 21.5%. Adjusted Group operating margin 30.8%. SG&A decline reflecting ongoing and active focus on cost management. R&D costs down in quarter; expect 2020 full year R&D costs to rise mid-to-high single digits as we continue to invest in late-stage pipeline
Total EPS 25.0p, -20% AER, -9% CER reflecting adverse changes on contingent consideration liabilities offset by asset disposals and improved operating performance
Adjusted EPS 35.6p, -8% AER, +1% CER reflecting operating profit growth partly offset by higher effective tax rate and non-controlling interest allocation of Consumer Healthcare profits
Q3 net cash flow from operations £0.9 billion. Free cash flow £(0.2) billion
19p dividend declared for the quarter
Guidance
On track to deliver full year 2020 Adjusted EPS at the lower end of the -1% to -4% range at CER
Pipeline highlights
Continued progress in biopharma pipeline with 3 approvals since Q2 results: FDA and EC approval of Blenrep as first anti-BCMA therapy for multiple myeloma; FDA approval of Trelegy for asthma; FDA approval of Nucala as first biologic treatment for Hypereosinophilic Syndrome (HES)
Positive European CHMP opinions in HIV for cabotegravir and rilpivirine as long-acting regimen for HIV treatment and for Zejula as first-line monotherapy maintenance treatment in ovarian cancer
Phase III trials to start in Q4 and Q1 2021 for RSV vaccines in maternal and older adults following positive Phase I/II data
First participant vaccinated in Phase III clinical trial of 5-in-1 meningitis ABCWY vaccine candidate
COVID-19 Solutions update
Phase I/II study of Sanofi-GSK adjuvanted recombinant protein-based vaccine candidate initiated. Phase III trial expected to start December 2020
Supply agreements reached with US, EU, UK, Canada for Sanofi-GSK vaccine. Statement of Intent signed with COVAX facility to support successful and equitable access to COVID-19 vaccines worldwide
Phase III study underway for Vir-GSK antibody (VIR-7831) for high-risk outpatients with COVID-19, with initial results potentially available by the end of 2020
GSK Q3 2020 results
Emma Walmsley, Chief Executive Officer, GSK said:
"GSK has responded well to a challenging operating environment this year with disciplined cost control and strong commercial momentum in key growth products including Nucala, Trelegy, Benlysta, 2 drug-HIV regimens, Zejula, Shingrix and our priority Consumer Healthcare brands. This, combined with improving vaccination rates this quarter, means we are on track to deliver within our earnings guidance range for 2020. In addition, we continue to make good progress on our preparations to separate the Group and create two new companies – in Biopharma and Consumer Health – which we believe will deliver options for sustainable growth and returns to shareholders.

"R&D delivery has continued with three product approvals since Q2 results and presentation of new clinical data to support the start of Phase III development for our very promising RSV vaccines. We are also urgently advancing possible COVID-19 Solutions with our partners, including clinical trials for antibody therapy VIR-7831 and three different adjuvanted vaccines. We expect to see data on all of these before the end of the year."