GRAIL Announces Partnership with Alignment Health Plan as First Medicare Advantage Plan to Offer Galleri® Multi-Cancer Early Detection Blood Test

On December 6, 2021 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported a partnership with Alignment Health Plan, a national Medicare Advantage health plan from Alignment Healthcare (NASDAQ: ALHC), to provide its Medicare Advantage members access to Galleri, GRAIL’s groundbreaking multi-cancer early detection blood test (Press release, Grail, DEC 6, 2021, View Source [SID1234596509]). Based in Orange, California, Alignment Health Plan is the first Medicare Advantage plan to offer the Galleri test as a complement to recommended single cancer screenings.

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"Providing innovative benefits to support the health and care needs of our members is what we do here at Alignment," said Dawn Maroney, markets president, Alignment Healthcare, and CEO, Alignment Health Plan (CA). "Taking preventive measures before signs and symptoms appear is key to finding cancer early when it is most treatable. We are excited to partner with GRAIL to provide seniors the tools they need to proactively manage their health."

New and existing Alignment Health Plan members who enroll in select HMO and PPO plans in California and North Carolina1 will have access to Galleri beginning Jan. 1, 2022. Galleri is available by prescription only.

"GRAIL is thrilled to partner with Alignment Health Plan to offer our first-of-its-kind Galleri test to a population that by age alone has an elevated risk of developing cancer," said Dr. Josh Ofman, president and chief medical officer at GRAIL. "Providing access to a technology that can detect cancer signals in the blood, even before symptoms appear, can help us decrease the burden of late-stage cancer diagnoses. We commend Alignment for its innovative and proactive approach to early cancer detection for Medicare Advantage members."

In a clinical study, Galleri demonstrated the ability to detect more than 50 types of cancer, over 45 of which lack recommended screening tests today, with a low false positive rate of less than 1%. When cancer is detected, Galleri can determine the cancer signal origin with high accuracy.

More than 600,000 people died from cancer last year in the United States, according to the American Cancer Society. This is in large part because the majority of cancers are found too late when outcomes are often poor. Recommended screening tests save lives, but only cover five cancer types in the U.S.: breast, colon, cervical, prostate, and (in high-risk adults) lung. In fact, about seven in ten cancer deaths have no recommended early detection screening.

Castle Biosciences Completes Acquisition of Cernostics

On December 06, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to transform disease management and improve patient outcomes, reported it has completed its acquisition of Cernostics, Inc. (Cernostics). Cernostics specializes in spatial biology and artificial intelligence-driven image analysis of tissue biopsies (Press release, Castle Biosciences, DEC 6, 2021, View Source [SID1234596508]). Its TissueCypher Barrett’s Esophagus Assay is the first precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE).

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"We are excited to continue the evolution of the Castle story with the closing of the Cernostics acquisition and our entry into the gastrointestinal space through the TissueCypher platform," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "The TissueCypher Barrett’s Esophagus Assay is designed to help predict the likelihood of BE’s progression to the more serious HGD or highly aggressive esophageal adenocarcinoma (EAC). Annually, approximately 400,000 endoscopies are performed on BE patients who meet the validated intended use population. We believe we have a unique opportunity to help physicians and patients make more informed disease management decisions based on deep interrogation of the biology of an individual patient’s esophageal biopsy."

Transaction Terms and Other Information

Under the terms of the definitive agreement, Cernostics has become a wholly owned subsidiary of Castle Biosciences. At closing, Castle paid approximately $30 million in initial consideration to Cernostics security holders, which consisted entirely of cash. Up to an additional $50 million in cash and/or common stock, at Castle’s sole discretion, is payable in connection with the achievement of certain milestones based on 2022 performance. The purchase price is subject to customary working capital and other adjustments.

TissueCypher Platform and the TissueCypher Barrett’s Esophagus Assay

The TissueCypher platform combines a unique approach designed to bring together the key elements of biologically aware artificial intelligence to deliver the spatialomics revolution to the clinician and enable individualized decision-making. This technology and platform are the core of the TissueCypher Barrett’s Esophagus Assay, the world’s first precision medicine test designed to predict future development of HGD and/or esophageal cancer in patients with BE. The TissueCypher Barrett’s Esophagus Assay is indicated for patients with endoscopic biopsy confirmed BE that is graded non-dysplastic, indefinite for dysplasia or low-grade dysplasia; it has been validated in multiple, independent studies of BE progressor patients. The TissueCypher Barrett’s Esophagus Assay is a proprietary Laboratory Developed Test with its own unique CPT PLA code (0108U) and has been on the Medicare Clinical Laboratory Fee Schedule since January 2021.

Sierra Oncology Announces Investor Event to Review MOMENTUM Trial Design and Available Phase 3 Momelotinib Data in Myelofibrosis

On December 06, 2021 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer, reported it will host an analyst and investor event on Thursday, December 16, 2021, at 12:00 pm ET (Press release, Sierra Oncology, DEC 6, 2021, View Source [SID1234596507]). The event will feature a presentation by Prithviraj Bose, MD, Department of Leukemia, MD Anderson Cancer Center, on the importance of treating anemia in myelofibrosis patients. Dr. Bose will also review momelotinib data from the Phase 3 SIMPLIFY studies. Sierra management will discuss the MOMENTUM trial design as well as highlight registration and commercialization preparations currently underway. An open question & answer session with all presenters will conclude the event.

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Analyst & Investor Event Webcast Information

Date and Time: Thursday, December 16, 2021, 12:00 pm ET

To register, please click here.

The presentation will be webcast live, and an archive of the presentation will be accessible for approximately 30 days after the event through the Sierra Oncology website: www.SierraOncology.com.

About Momelotinib

Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1/ALK2 inhibitor currently under investigation for the treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.

Sierra Oncology is currently awaiting topline results of the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study evaluating momelotinib for the treatment of symptomatic and anemic myelofibrosis patients. Top-line data are anticipated by February 2022. Assuming positive data, the company plans to file a New Drug Application with the US Food & Drug Administration (FDA) in the second quarter of 2022. The FDA has granted Fast Track designation for momelotinib.

PDC*line Pharma Raises €17.5 Million in Series B2 Financing Round

On December 6, 2021 PDC*line Pharma, a clinical stage biotech company developing a new class of potent and scalable active off-the-shelf cancer vaccine, reported the completion of its Series B2 round of financing (Press release, PDC Line Pharma, DEC 6, 2021, View Source [SID1234596506]). The company has raised a total of €17.5 million ($20.3M) with Belgian and South-Korean investors.

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Less than two years after its €20M ($23.2M) B1 round of fundraising, announced in January 2020, PDC*line Pharma has attracted new investors and secured a further capital increase of €11.8M ($13.7M). In addition, the company has received a €5.7M ($6.6M) grant in repayable aid from the Walloon Region of Belgium, which has backed the company since its arrival in 2016. The company will therefore have raised a total of €37.5M euros in this series B round.

This financing round, led by Korea Investment Partners, a leading multi-billion dollar South-Korean fund, also involved a syndicate of new South-Korean investors in life sciences: Alpha Holdings, Brain Asset Management and Hansongneotech Co. Ltd. Existing investors also participated: Noshaq Group (ex-Meusinvest), Sambrinvest (the Charleroi investment fund), SFPI-FPIM (the Belgian Federal Holding and Investment Company), SRIW (The Regional Investment Company of Wallonia) and Smart Korea UTC Bio-Healthcare Venture Fund.

"I am delighted to welcome Alpha Holdings, Hansongneotech Co. Ltd. and Brain Asset Management to the syndicate. I would also like to thank our existing investors for their continued support of the PDC*line Pharma team," said Eric Halioua, CEO of PDC*line Pharma. "This new round represents an important validation of our platform and development strategy with the on-going phase I/II trial of PDC*lung01, our vaccine candidate for lung cancer."

The objectives of the phase I/II study (PDC-LUNG-101) are to assess the safety, tolerability, immunogenicity and preliminary clinical activity of the drug candidate, PDC*lung01, associated or not with anti-PD-1 treatment in NSCLC. A total of 64 evaluable HLA-A*02:01 positive NSCLC patients are expected in clinical centers in Belgium, France, Germany, the Netherlands and Poland. PDC*lung01 consists of PDC*line professional antigen-presenting cells loaded with HLA-A2 restricted peptides, derived from seven shared tumor antigens.

"We are delighted to lead this B2 series financing. PDC*line Pharma’s cancer vaccine platform is both highly innovative and meets an important medical need. The company leadership team has demonstrated its ability to deliver on an ambitious plan," said Sangwoo Lee, managing director at Korea Investment Partners.

"We welcome the continued strong support of the Walloon region and the new funding by a mix of Belgian and South-Korean investors. PDC*line Pharma is an emblematic example of a Belgian biotech company succeeding in its international development in Asia, thanks to its licensing deal with LG-Chem and the support of leading Asian investors," said François Fontaine, general advisor to PDC*line Pharma at SFPI-FPIM.

Legal advisors to PDC*line: Bird & Bird

Bavarian Nordic A/S Announces Completion of Directed Issue of 6,373,680 New Ordinary Shares

On December 6, 2021 Bavarian Nordic A/S ("Bavarian Nordic" or the "Company") reported its intention to raise new capital through an accelerated bookbuilding process. The offering (the "Offering") of new shares (the "New Shares") in Bavarian Nordic has now been successfully completed. Reference is made to company announcement no. 40 of 6 December 2021 (Press release, Bavarian Nordic, DEC 6, 2021, View Source [SID1234596505]).

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Bavarian Nordic has successfully completed a directed issue and private placement of 6,373,680 new shares at an offer price of DKK 268 per share, raising gross proceeds to Bavarian Nordic of DKK 1,708 million.

The Offering has not been registered under the U.S. Securities Act and was made pursuant to applicable exemptions from the obligation to publish a prospectus in Denmark as well as exemptions from the U.S. Securities Act and the securities laws of other applicable jurisdictions in a directed issue and private placement and subscribed for by eligible qualified institutional and professional investors in Denmark and in certain other jurisdictions at market price and without pre-emption rights for Bavarian Nordic’s existing shareholders.

The net proceeds from the Offering will be used in accordance with company announcement no. 40 of 6 December 2021.

As the Offering was oversubscribed, an individual allocation of the New Shares was made.

Bavarian Nordic has in connection with the Offering, agreed to undertake a lock-up commitment for 180 calendar days following settlement of the Offering (subject to certain exceptions). In addition, members elected at the general meeting of Bavarian Nordic’s board of directors as well as members of the executive management have in connection with the Offering, agreed to undertake a lock-up commitment for 90 calendar days following settlement of the Offering (subject to certain exceptions).

CAPITAL INCREASE
Subject to settlement, a share capital increase will be registered with the Danish Business Authority and the share capital of Bavarian Nordic will hereafter consist of 70,468,393 shares of DKK 10 each, equivalent to a registered share capital of DKK 704,683,930.

The New Shares represent approximately 9.94 % of Bavarian Nordic’s registered share capital before the capital increase and will account for approximately 9.04 % of Bavarian Nordic’s registered share capital upon completion of the capital increase.

ADMISSION TO TRADING AND OFFICIAL LISTING
The New Shares will be issued under the temporary ISIN code DK0061682721. No application for admission to trading and official listing has been, or will be, filed for the New Shares issued under the temporary ISIN code, and the temporary ISIN code will only be registered with VP Securities A/S for subscription of the New Shares. The temporary ISIN code in VP Securities A/S will be merged with the permanent ISIN code for the existing shares, DK0015998017, as soon as possible following registration of the share capital increase with the Danish Business Authority. The New Shares are expected to be admitted to trading and official listing on Nasdaq Copenhagen A/S, in the permanent ISIN code for the existing shares, DK0015998017, on or around 10 December 2021.

The admission to trading and official listing of the New Shares is subject to the Offering not being withdrawn prior to the settlement of the Offering and the Company making an announcement to that effect.

EXPECTED TIMETABLE FOR THE OFFERING

Date Event
Thursday 9 December 2021 Settlement and payment for the New Shares
Thursday 9 December 2021 Registration of the capital increase with the Danish Business Authority
Friday 10 December 2021 Admission to trading and official listing of the New Shares on Nasdaq Copenhagen A/S
Monday 13 December 2021 Merger of the temporary ISIN code with the permanent ISIN code in the system of VP Securities A/S
NEW SHARES
The decision to launch an offering of new shares in a directed issue was made pursuant to Article 5a(2) in Bavarian Nordic’s articles of association pursuant to which its board of directors is authorised to make share capital increases without pre-emption rights for the existing shareholders at market price.

The New Shares will rank pari passu in all respects with existing shares in Bavarian Nordic. The New Shares will be negotiable instruments, and no restrictions will apply to their transferability. No shares, including the New Shares, carry or will carry any special rights. Rights conferred by the New Shares, including voting rights and dividend rights, will apply from the time when the capital increase is registered with the Danish Business Authority. The New Shares must be registered in the name of the holder in the Company’s register of shareholders.

JOINT GLOBAL COORDINATORS AND JOINT BOOKRUNNERS
Citigroup Global Markets Limited and Nordea Danmark, filial af Nordea Bank Abp, Finland are acting as Joint Global Coordinators and Joint Bookrunners in connection with the Offering (jointly the "Joint Global Coordinators and Joint Bookrunners").

Kromann Reumert and Latham & Watkins LLP act as Danish and U.S. legal advisors respectively to the Company. Plesner acts as Danish legal advisors to the Joint Global Coordinators and Joint Bookrunners.