On January 11, 2021 Targovax ASA, a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reoported that it has been invited to present at H.C. Wainwright’s BioConnect 2021 Conference, being held virtually on January 11-14, 2021 (Press release, Targovax, JAN 11, 2021, View Source [SID1234573772])

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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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Øystein Soug, CEO of Targovax, will hold a company presentation to conference attendees. The recording will be available on-demand via the H.C. Wainwright conference portal

On January 11, 2021 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, reported that Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys, will present at the 39th Annual J.P. Morgan Healthcare Conference on Wednesday January 13 at 2:50 p.m. EST (Press release, MorphoSys, JAN 11, 2021, View Source [SID1234573770]).

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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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Live audio of the presentation can be accessed from the Media and Investors section under Conferences on MorphoSys’ website, www.morphosys.com. The presentation as well as a replay of the webcast will also be available on MorphoSys’ website.

On January 11, 2021 Alligator Bioscience AB (publ)’s ("Alligator" or the "Company") reported that rights issue of shares which was resolved upon by the Board of Directors on December 15, 2020 pursuant to the authorization from the Annual General Meeting on May 5, 2020 (the "Rights Issue") (Press release, Alligator Bioscience, JAN 11, 2021, View Source [SID1234573769]). The general public also has the opportunity to subscribe for shares in the Rights Issue.

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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 ensure continued successful development in accordance with the Company’s business plan and strategy, the Board of Directors of Alligator has resolved to carry out the Rights Issue of approximately SEK 86 million before issue costs. The expected net proceeds from the Rights Issue will be used to initiate and conduct Phase II studies for mitazalimab and to complete phase I study and initiate preparatory work on Phase II study for ATOR-1017. The Rights Issue is secured to 100 per cent by subscription undertakings and guarantee commitments.

For complete information on the Rights Issue, please see the prospectus (the "Prospectus"), which has been prepared by the Board of Directors in connection with the Rights Issue.

Comment from Alligator’s CEO, Per Norlén
"With the capital injection from the rights issue, we secure the start of important efficacy studies for our focus projects mitazalimab and ATOR-1017. Just before year-end, we submitted a CTA for mitazalimab, an application to start Phase II in pancreatic cancer. For ATOR-1017, we plan to start Phase II studies in the second half of 2021, with gastric cancer as a prioritized indication. Based on strong data from preclinical models and clinical Phase I, we see great opportunities for both mitazalimab and ATOR-1017 to successfully treat patients with these cancers."– Per Norlén, CEO of Alligator

The Rights Issue
The Rights Issue comprises a maximum of 14,277,723 shares. The Rights Issue takes place with priority for those who were registered as shareholders in the Company on the record date, January 5, 2021. One (1) existing share in the Company entitles to one (1) subscription right. Five (5) subscription rights entitle to subscribe for one (1) new share.

Timeline for the Rights Issue

January 11 – January 21, 2021 – Trading in subscription rights
January 11 – January 25, 2021 – Subscription period
January 11, 2021 – Until the Rights Issue has been registered by the Swedish Companies Registration Office – Trading in paid-up subscribed shares (Sw. "BTA")
January 28, 2021 – Estimated publication of outcome of Rights Issue
Investor presentations
The Company will be presenting at Redeye Fight Cancer Seminar on January 21, 2021. Additional investor presentations may be arranged during the subscription period. Invitations will be presented on Alligator’s and Redeye AB’s respective websites.

Prospectus
The Prospectus, containing complete terms and conditions, is available on the Company’s, Aktieinvest FK AB’s and Redeye AB’s respective websites (www.alligatorbioscience.com, View Source and View Source). The Prospectus is also available on the Swedish Financial Supervisory Authority’s website (www.fi.se). Subscription forms are available on the Company’s and Redeye AB’s respective websites. Subscription forms can also be obtained by contacting Aktieinvest FK AB on telephone number 08-5065 1795.

Advisers
Redeye AB acts as financial adviser, Setterwalls Advokatbyrå AB acts as legal adviser and Aktieinvest FK AB acts as issuing agent in connection with the Rights Issue.

On January 11, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the CE-IVD launch of its automated digital pathology algorithms, uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis for breast cancer to help determine the best treatment strategy for each patient (Press release, Hoffmann-La Roche, JAN 11, 2021, View Source [SID1234573768]). The image analysis algorithms use artificial intelligence to support pathologists in making faster, more accurate patient diagnoses in breast cancer.

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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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A mutation in the HER2 gene, which occurs in as many as 20 percent of the 2.1 million cases of breast cancer diagnosed globally each year, is responsible for aggressive growth in some patients. Identifying this mutation is important in determining which patients may benefit from targeted treatment.1,2

"About 15 to 20 percent of women diagnosed with breast cancer are HER2 positive, which makes fast and accurate diagnosis critical," said Thomas Schinecker, CEO Roche Diagnostics. "Roche is continuing to innovate in HER2 diagnostics by providing precise information through image analysis algorithms for pathology decision support."

uPath HER2 (4B5) image analysis for breast cancer helps pathologists to quickly determine whether tumors are positive for the HER2 biomarker, highlighting positively stained tumor cell membranes with a clear visual overlay for easy reference. uPath HER2 Dual ISH image analysis for breast cancer assists the pathologist in the determination of HER2 gene amplification. A heatmap is provided to guide pathologists to areas of interest where the algorithm can identify cells to inform the determination of a treatment strategy.

Validated on the VENTANA HER2 (4B5) assay and the VENTANA HER2 Dual ISH DNA Probe Cocktail, the algorithms are ready-to-use and integrated within the Roche uPath enterprise software. The uPath HER2 (4B5) image analysis and uPath HER2 Dual ISH image analysis algorithms for breast cancer expand Roche’s digital pathology portfolio to empower precision diagnosis. Roche is continuing to innovate in HER2 diagnostics through image analysis algorithms that provide an actionable assessment of scanned slide images that are objective and reproducible.

About uPath image analysis algorithm suite
The uPath image analysis algorithm suite for pathology decision support offers ready-to-use image analysis tools, providing fast, consistent and automated analysis so that pathologists can quickly, accurately and confidently assess immunohistochemistry and in situ hybridization. All algorithms in the suite for uPath software will provide image analysis of VENTANA DP 200 scanned slide images stained with a Roche Tissue Diagnostics assay. Together, Roche is delivering a new foundation of its digital pathology solution which will enable the development of artificial intelligence-based image analysis algorithms that can provide pathologists more tools to improve efficiency and precision.

Roche is delivering the end-to-end digital pathology solution from tissue staining to producing high-quality digital images that can be reliably assessed using automated clinical image analysis algorithms. Roche minimizes the variables that can impact analysis, and it is this end-to-end development that produces the quality results customers can depend on for making clinical decisions. With the acceleration of immunotherapy and the development of more complex assays, Roche is moving these traditionally research-oriented tools into routine clinical practice.

About breast cancer
Breast cancer is the second most common cancer in the world, with an estimated 1.7 million new cancer cases diagnosed in 2012 (25% of all cancers). It is the most common cancer in women globally. Incidence rates vary nearly four-fold across the world regions, with rates ranging from 27 per 100,000 in Africa and Asia to 92 per 100,000 in North America.1,2

On January 11, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company expects to report revenue between $464.5 million and $467.5 million for the fourth quarter ended Dec. 31, 2020 (Press release, Exact Sciences, JAN 11, 2021, View Source [SID1234573753]).

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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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"I’m incredibly proud of how the Exact Sciences team came together during 2020 to make progress towards our mission of eradicating cancer and the suffering it causes," said Kevin Conroy, chairman and CEO of Exact Sciences. "Following our combination with Thrive, we are confident in making blood-based, multi-cancer screening a reality and being a leading provider of earlier, smarter cancer tests for patients at every step of their journey. We’ve never been more excited about the impact Exact Sciences will have on patient lives with Cologuard, Oncotype, and our future tests."

Preliminary, Unaudited Fourth Quarter 2020 Financial Results

For the three-month period ended December 31, 2020, as compared to the same period of 2019 (where applicable):

Expected total revenue between $464.5 million and $467.5 million
Expected Screening revenue between $249 million and $250 million, an increase of 9 percent
Expected Precision Oncology revenue between $117 million and $118 million
Expected COVID-19 testing revenue between $98.5 million and $99.5 million
Preliminary, Unaudited 2020 Financial Results

For the twelve-month period ended December 31, 2020, as compared to the same period of 2019 (where applicable):

Expected total revenue between $1.490 billion and $1.493 billion
Expected Screening revenue between $814.5 million and $815.5 million, an increase of 1 percent
Expected Precision Oncology revenue between $440 million and $441 million
Expected COVID-19 testing revenue between $235 million and $236 million
For the fourth quarter and 2020, Screening includes laboratory service revenue from Cologuard and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype products.

Exact Sciences has not completed preparation of its financial statements for the fourth quarter or full year of 2020. The revenue ranges presented in this news release for the fourth quarter of 2020 and for the year ended Dec. 31, 2020 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results for the fourth quarter of 2020. Exact Sciences is in the process of completing its customary year-end close and review procedures as of and for the year ended Dec. 31, 2020, and there can be no assurance that final results for this period will not differ from these estimates. During the course of the preparation of Exact Sciences’ consolidated financial statements and related notes as of and for the year ended Dec. 31, 2020, the company’s independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary financial estimates presented herein.

Exact Sciences plans to report 2020 financial results during its February 2021 earnings call.

About Cologuard
Cologuard was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again.

Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx only.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.