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Ziopharm Oncology to Report Second Quarter Financial Results on August 9, 2021

On July 26, 2021 Ziopharm Oncology, Inc. (Nasdaq: ZIOP), reported that management will host a conference call and webcast on Monday, August 9, at 4:30 p.m. EDT to provide a corporate update and discuss financial results for the second quarter ended June 30, 2021 (Press release, Ziopharm, JUL 26, 2021, View Source [SID1234585182]).

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The conference call can be accessed by dialing 877-451-6152 (U.S. and Canada) or 201-389-0879 (International). The passcode for the conference call is 13721210. A live webcast may be accessed using the link here, or by visiting the "Investors" section of the Ziopharm website at www.ziopharm.com. The call will be recorded and available for replay on the Company’s website for approximately 90 days after the call.

Cizzle Biotechnology Collaborate with FairJourney Biologics to Develop Proprietary Antibodies for Early Lung Cancer Detection Tests

On July 26, 2021 Cizzle Biotechnology Holdings Plc ("Cizzle Biotechnology" or the "Company") reported that Collaboration with FairJourney Biologics to Develop Proprietary Antibodies for Early Lung Cancer Detection Tests (Press release, FairJourney Biologics, JUL 26, 2021, https://fjb.pt/collaboration/cizzle-biotechnology-collaboration-with-fairjourney-biologics-to-develop-proprietary-antibodies-for-early-lung-cancer-detection-tests/ [SID1234585181])

Cizzle Biotechnology, the UK based developer of a blood test for the early detection of a majority of the different forms of lung cancer, is pleased to announce the signing of a collaboration with FairJourney Biologics for the development and supply of proprietary key monoclonal antibodies that are the foundation for developing an enzyme-linked immunosorbent assay ("ELISA"), together with appropriate core reagents which are important requirements in the Company’s roadmap for the commercial development of the Company’s prototype CIZ1B biomarker test.

The Company’s strategy, as outlined in its prospectus published in May 2021, is to develop Cizzle Biotechnology’s prototype CIZ1B biomarker test into a commercial, CE marked and/or FDA 510(k) cleared diagnostic immunoassay that can be readily performed as a sufficiently reliable test in a hospital setting.

In order to pursue this goal, the Directors believe that Cizzle Biotechnology’s testing methodology needs to be such that it can be deployed in a standardised sensitive and specific format for potential use in hospital laboratories. To achieve this, one approach is to take the current prototype ELISA assay developed by Cizzle Biotechnology and update it so that it can be performed using a monoclonal antibody or other detector proteins which may meet the requirements of regulatory bodies to bring the test to market. This requires that Cizzle Biotechnology work with a leading manufacturer such as FairJourney Biologics to produce the antibodies and reagents that may be used to validate its test format in clinical trials.

FairJourney Biologics, headquartered in Porto, Portugal, is a leading biologics clinical research organisation ("CRO"), providing integrated services across antibody discovery, engineering and production to global biopharma companies. They have successfully completed more than 500 projects with over 100 biotechnology and pharmaceutical companies. FairJourney Biologics merged with Cambridge, UK, based IONTAS in 2020 which was founded by John McCafferty, the co-discoverer of antibody phage display for which Professor Sir Greg Winter was awarded the Nobel prize for Chemistry in 2018. Earlier this year FairJourney Biologics opened a new purpose-built state of the art facility to carry out the type of key development activities that will be central to the programme for Cizzle Biotechnology.

Commenting, Allan Syms, Executive Chairman, said: "I am delighted that we have contracted with FairJourney Biologics to develop and supply the monoclonal antibodies and reagents required for our ELISA assay and future diagnostic platforms and tests. FairJourney Biologics is a recognised leader in its field and will be an important partner in our strategy to commercialise as quickly as possible our CIZ1B biomarker test for the early-stage detection of lung cancer.

"Since the admission of Cizzle Biotechnology to trading on the London Stock Exchange in May we are already making significant progress and I look forward to providing further updates in due course."

Commenting, António Parada, Chief Executive Officer, said: "We are excited to collaborate with Cizzle Biotechnology in discovering novel antibodies to be used as promising diagnostic tools. We believe that innovative diagnostic platforms as the CIZ1B biomarker test will be a major step to hinder the progression of lung cancer and improve patient’s prognosis in the long-term."

Chugai Announces 2021 Half Year Results

On July 26, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the first half of fiscal year 2021 (Press release, Chugai, JUL 26, 2021, View Source [SID1234585179]).

"We had a very good second quarter with strong earnings and steady progress in R&D activities. Revenues and profits grew significantly due to increases in domestic and overseas sales as well as Hemlibra royalties. As a result, both revenues and profits for the first half turned to growth, despite declines in the first quarter. As for new products, in-house product Enspryng received regulatory approval in Europe and is now being rolled out in Japan, the U.S. and Europe. In Japan, we launched Polivy and received approval for Evrysdi, two products we expect will drive future growth. Progress has also been made in the development of COVID-19 treatments. Actemra received Emergency Use Authorization from the U.S. FDA, and Ronapreve received Special Approval in Japan. In addition, I am pleased that we are able to report progress in many other projects in both our early- and late-stage pipelines. We will continue focusing on the creation of innovation to achieve our mission of contributing to the medical community and human health around the world." said Dr. Osamu Okuda, Chugai’s President and CEO.

[Half year results for 2021]

Revenues increased by 6% and Core operating profit increased by approximately 15% for the half year (Core-basis), mainly due to a significant, roughly 40% increase in royalties and other operating income.

Revenues, which declined by 10% year-on-year in the first quarter, were almost flat compared to the same period of the previous year, while royalties and other operating income increased significantly, resulting in an overall increase in revenues. Sales, both domestic and overseas, remained at the same level as the first half of last year. Domestic sales in the oncology field increased by a little less than 10%, with the continued sales growth in Tecentriq and Kadcyla. On the other hand, domestic sales in the primary field decreased by double digits, despite the contribution of the new product Enspryng, due to the significant impact of the NHI drug price revision and generic competition. In total, domestic sales were almost flat compared with the same period of the previous year. As for overseas sales, increases in the sales of Hemlibra, which nearly doubled year-on-year, and other products offset the decrease in the sales of Actemra. Royalties and other operating income increased by approximately 40% mainly due to an increase in royalties and profit-sharing income relating to Hemlibra.

Cost to sales ratio improved by 2.8 % points year-on-year to 40.1%, mainly due to an increase in the proportion of in-house products including Hemlibra. Operating expenses increased by 10% due to the double-digit increase in research and development expenses associated with the progress of development projects. Marketing and distribution, and general and administration expenses also increased as these expenses decreased last year due to lower business activities caused by the spread of COVID-19. As a result, core operating profit increased by approximately 15%.

The Company also made good progress in research and development. Among the next growth drivers, Enspryng, a recycling antibody created by Chugai, obtained regulatory approval in Europe following Japan and the U.S. for the treatment of neuromyelitis optica spectrum disorder. Evrysdi, an SMN2 splicing modifier, obtained regulatory approval in Japan in June as the first oral drug for spinal muscular atrophy. A regulatory application was filed for faricimab, the first bispecific antibody in ophthalmology, for two indications, diabetic macular edema and neovascular age-related macular degeneration. An application was also filed for the line extension of Tecentriq as adjuvant therapy for non-small cell lung cancer. In addition, both early- and late-stage development products are steadily progressing. Phase III global clinical trials for several projects started in order to examine new indications. Phase I clinical trials for an in-house project SOF10 and other projects also started in Japan.

In the efforts to develop a treatment for COVID-19, the anti-IL-6 receptor antibody Actemra, created by Chugai, received Emergency Use Authorization from the U.S. FDA in June for hospitalized adults and children. A regulatory filing in Japan is planned by the end of this year. The antibody cocktail Ronapreve, in-licensed from Roche, obtained Special Approval in Japan in July following the filing of application in June. For AT-527, an oral antiviral agent also in-licensed from Roche, Chugai participated in a Phase III global clinical trial for the treatment of mild to moderate COVID-19 in outpatient setting and advances the development. Chugai ended the antibody research collaboration with A*STAR for COVID-19 with the completion of preclinical assessment studies for the lead antibody candidates against SARS CoV2. The collaboration was announced in May 2020.

About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results, and are consistent with the Core concept disclosed by Roche. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

PerkinElmer to Acquire Antibody, Reagent Maker BioLegend for $5.25B

On July 26, 2021 PerkinElmer reported it agreed to acquire BioLegend, a provider of life science antibodies and reagents, for approximately $5.25 billion in cash and stock—the largest acquisition in the buyer’s history—in a deal designed to position PerkinElmer as a leading precision medicine company by accelerating its life science growth within clinical diagnostics (Press release, PerkinElmer, JUL 26, 2021, View Source [SID1234585178]).

Based in San Diego, BioLegend provides antibodies and reagents in areas that include cytometry, proteogenomics, multiplex assays, recombinant proteins, magnetic cell separation, and bioprocessing, for both academic and biopharmaceutical customers. In addition to its development of antibodies and reagents, the company has developed a complementary portfolio focused on tapping emerging, high-growth areas such as biologics, cell and gene therapy, proteogenomics, and recombinant proteins.

"We are thrilled to have the opportunity to bring our technologies and innovative cultures together to create seamless solutions to push science and discovery forward," Prahlad Singh, PerkinElmer’s president and CEO, said in a statement. "We believe joining our teams presents an incredible opportunity to accelerate discoveries that help life science researchers leverage ever-developing technologies and novel approaches to better understand and fight disease."

Investors responded to the announcement of the BioLegend acquisition by sending PerkinElmer shares up $3.66 (2.23%) to $168 a share as of 11:51 a.m. ET.

Privately-held BioLegend has more than 700 employees based largely in the United States, with revenues that are estimated to reach $380 million in 2022, with revenue growth expected to reach the mid-teens, excluding synergies. PerkinElmer employs about 14,000 people, serves customers in 190 countries, and finished last year with revenues of approximately $3.8 billion.

PerkinElmer and BioLegend have identified immediate revenue synergies that are expected to reach $100 million annually by the fifth year following the close of the deal, but added that no "significant" cost synergies are planned.

Adding to revenue, margin

According to PerkinElmer, the combination of the companies is estimated to enhance its revenue growth and margin by adding $0.30 of adjusted earnings per share in the first full year following the close of the transaction, and more than $0.50 per share in the second year following the close.

In a separate announcement today, PerkinElmer reported finishing the second quarter with net income of $245.93 million, up 79% from $137.162 million in Q2 2020, on GAAP revenue that jumped 51% to $1.229 billion from $811.718 million in the second quarter of last year.

The transaction is expected to close by the end of 2021, subject to regulatory approvals and other customary closing conditions.

Upon closing of the deal, BioLegend’s San Diego campus will become PerkinElmer’s global Center of Excellence (CoE) for research reagent content development for the combined company. Also, PerkinElmer will add new segments to its existing life science franchise.

PerkinElmer now has a life sciences market within its Discovery & Analytical Solutions Segment that combines its life sciences research and laboratory services markets. In the life sciences research market, PerkinElmer includes solutions such as its reagents, informatics, and detection and imaging technologies for biopharma companies, contract research organizations, and academic institutions.

The company also provides services designed to help customers in the laboratory services market increase efficiencies and production time while reducing laboratory maintenance costs, such as its OneSource laboratory service business.

PerkinElmer said it had secured a full commitment to bridge financing from Goldman Sachs Bank for the cash portion of the purchase price.

Back in 2009, BioLegend agreed to offer immunoassay development and bioanalytical testing based on PerkinElmer’s AlphaLISA assay technology, through a collaboration of undisclosed value.

"We are very excited to join the PerkinElmer family. The combination will afford us the opportunity to continue to build on our two-decade foundation of innovative science and scale in new and highly attractive PerkinElmer areas such as clinical diagnostics and food safety testing," added Gene Lay, BioLegend’s founder, president, and CEO. "The BioLegend team is eager to enter this new chapter with PerkinElmer, furthering our mission of enabling legendary discovery from research to cure."

Ad hoc: MorphoSys AG to update financial guidance for 2021 and reduce financial liabilities

On July 26, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported an update of its financial guidance for 2021 after preliminary completion of the latest evaluation of MorphoSys’ half year 2021 financial performance (Press release, MorphoSys, JUL 26, 2021, View Source [SID1234585177]).

Based on the preliminary unaudited consolidated results for the first six months 2021, MorphoSys now expects Group revenues in the range of € 155 to € 180 million (previously: € 150 to € 200 million, provided on March 15, 2021 and reiterated on May 5, 2021). The updated revenue guidance primarily reflects updated Monjuvi product sales expectations.

MorphoSys now expects Group operating expenses, which is comprised of R&D and Selling, as well as General & Administrative expenses, in the range of € 435 to € 465 million (previously: € 355 to € 385 million). R&D expenses now are expected to comprise 52 to 57% of Group operating expenses (previously 45-50%), excluding one-time transaction-related costs. The updated guidance for Group operating expenses mainly reflects the acquisition of Constellation Pharmaceuticals (Constellation), which was completed on July 15, 2021. The revised Group range also includes one-time transaction costs of € 36 million, related to the agreements with Constellation and Royalty Pharma.

As a result of the updated Monjuvi product sales expectations, the balance sheet position "Financial Liabilities from Collaborations, Net of Current Portion" is reduced from € 547.6 million (balance as of March 31, 2021) to € 445.9 million (balance as of June 30, 2021). The balance in "Financial Liabilities from Collaborations, Net of Current Portion", reflects an accounting view of expected profits from the net product sales of Monjuvi in the U.S. in the r/r DLBCL setting owed to our partner Incyte. The reduction in Financial Liabilities from Collaborations has no impact to cash.

Full results will be published as planned on July 28, 2021.