ViewRay Announces Proposed Public Offering of Common Stock

On December 2, 2019 ViewRay, Inc. (Nasdaq: VRAY), maker of the MRIdian, which combines MRI and external-beam radiation therapy to simultaneously image and treat cancer patients, reported that it has commenced an underwritten public offering of $75.0 million of shares of its common stock (Press release, ViewRay, DEC 2, 2019, View Source [SID1234551844]). In addition, ViewRay expects to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of shares of common stock at the public offering price, less the underwriting discounts and commissions. All of the shares of common stock to be sold in the offering will be offered by ViewRay. 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, or as to the actual size or terms of the offering.

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ViewRay intends to use the net proceeds from the offering for working capital and general corporate purposes, including capital expenditures, research and development expenses, investments, commercial expenses, clinical data generation costs and infrastructure expenses.

Piper Jaffray & Co. is acting as the sole book-running manager for the offering.

The common stock will be offered and sold pursuant to an effective shelf registration statement on Form S-3 (File No. 333-229145) filed by ViewRay with the Securities and Exchange Commission ("SEC") and only by means of a prospectus supplement and accompanying prospectus included in the registration statement. A preliminary prospectus supplement related to the offering will be filed with the SEC. Prospective investors should read the preliminary prospectus supplement, when available, and the accompanying prospectus and other documents ViewRay has filed with the SEC for more complete information about ViewRay and the offering. These documents are available at no charge by visiting the SEC’s website at View Source Alternatively, copies of the preliminary prospectus supplement, when available, and the accompanying prospectus may be obtained by contacting Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].

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 of these securities under the securities laws of any such state or jurisdiction.

Centene Corporation Announces Extension of Exchange Offers and Consent Solicitations for WellCare Notes

On December 2, 2019 Centene Corporation (NYSE:CNC) ("Centene") reported the extension of the expiration date of the offers to exchange (the "Exchange Offers") notes (the "WellCare Notes") issued by WellCare Health Plans, Inc. (NYSE:WCG) ("WellCare") for up to $1,950,000,000 aggregate principal amount of new notes to be issued by Centene (the "Centene Notes") and cash and the related consent solicitations (the "Consent Solicitations") being made by Centene on behalf of WellCare to adopt certain proposed amendments (the "Amendments") to the indentures governing the WellCare Notes (Press release, Centene , DEC 2, 2019, View Source [SID1234551843]). Centene hereby extends such expiration date from 5:00 p.m., New York City time, on December 2, 2019, to 5:00 p.m., New York City time, on December 18, 2019 (as the same may be further extended, the "Expiration Date").

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On November 14, 2019, requisite consents were received and supplemental indentures were executed, eliminating substantially all restrictive covenants and certain events of default and other provisions in each of the indentures governing the WellCare Notes. Such supplemental indentures will only become operative upon the settlement date of the Exchange Offers.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement dated November 1, 2019, as amended on November 12, 2019 and the related letter of transmittal and consent hereby, each as amended hereby, and are conditioned upon the closing of Centene’s acquisition of WellCare (the "Merger"), which condition may not be waived by Centene, and certain other conditions that may be waived by Centene.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and immediately prior to the closing of the Merger, which is expected to occur by the first half of 2020. As a result, the Expiration Date may be further extended one or more times. Centene will provide notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on December 2, 2019, the principal amounts of WellCare Notes set forth in the table below had been validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of WellCare Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" under Rule 144A or not a "U.S. person" and outside the United States under Regulation S for purposes of applicable securities laws. Except as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the confidential offering memorandum and consent solicitation statement dated November 1, 2019 as amended on November 12, 2019 and the related letter of transmittal and consent, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470-4200 (U.S. toll-free) or (212) 430-3774 (banks and brokers). The eligibility form is available electronically at: View Source

This press release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, or the solicitation of tenders or consents with respect to, any security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful. The Exchange Offers and Consent Solicitations are being made solely pursuant to the offering memorandum and consent solicitation statement dated November 1, 2019, as amended on November 12, 2019 and as amended hereby and the related letter of transmittal and consent, and only to such persons and in such jurisdictions as are permitted under applicable law.

The Centene Notes offered in the Exchange Offers have not been registered under the Securities Act of 1933, as amended, or any state securities laws. Therefore, the Centene Notes may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act of 1933, as amended, and any applicable state securities laws.

Mallinckrodt Moves Date and Time of Its Fireside Chat at Piper Jaffray Annual Healthcare Conference

On December 2, 2019 Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, reported that the Company now will present at the Piper Jaffray Annual Healthcare Conference on Wednesday, Dec. 4, 2019 at 12:30 p.m. Eastern (Press release, Mallinckrodt, DEC 2, 2019, View Source [SID1234551842]).

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Mark Trudeau, President and Chief Executive Officer, and Steven Romano, M.D., Executive Vice President and Chief Scientific Officer, will represent the company in a fireside chat.

Individuals who cannot attend the meeting in person can find webcast information at: http://www.mallinckrodt.com/investors. A replay will also be available following the meeting.

Boundless Bio to Present at the Piper Jaffray 31st Annual Healthcare Conference

On December 2, 2019 Boundless Bio, a company interrogating and targeting extrachromosomal DNA (ecDNA) in aggressive cancers, reported that it will present at the Piper Jaffray 31st Annual Healthcare Conference in New York, NY (Press release, Boundless Bio, DEC 2, 2019, View Source [SID1234551841]).

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Zachary Hornby, President and Chief Executive Officer of Boundless Bio, will give a company overview on Thursday, Dec. 5, 2019 from 2:50 – 3:10 p.m. EST.

About ecDNA

Extrachromosomal DNA, or ecDNA, are large circles of DNA containing genes that are outside the cells’ chromosomes and can make many copies of themselves. ecDNA can be rapidly replicated within the cell, causing high numbers of oncogene copies, a trait that can be passed to daughter cells in asymmetric ways during cell division. Cells have the ability to upregulate or downregulate ecDNA and resulting oncogenes to ensure survival under selective pressures, including chemotherapy or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment evasion. ecDNA are rarely seen in healthy cells but are found in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes

NantKwest Announces Phase 1 Results for First-in-Human PD-L1 Tumor-Targeted Natural Killer Cells (PD-L1.t-haNK) in Patients with Locally Advanced or Metastatic Solid Cancers

On December 2, 2019 NantKwest, Inc. (Nasdaq: NK), a clinical-stage natural killer cell-based therapeutics company, reported promising safety data generated from the first six patients in its QUILT-3.064 trial (Press release, NantKwest, DEC 2, 2019, View Source [SID1234551840]). The first-in-human study evaluated the safety and preliminary efficacy of the Company’s first-in-class, tumor-targeted PD-L1.t-haNK cell therapy in patients with locally advanced or metastatic solid tumors.

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"The unique dual-targeting of PD-L1.t-haNK to both PD-L1 expressing tumors and therapeutic monoclonal antibodies has the potential to be transformative to the treatment of advanced solid tumors with cell-based therapies," said Dr. Patrick Soon-Shiong, the Chairman and CEO of NantKwest. "PD-L1.t-haNK is a cryopreserved, off-the-shelf product that can rapidly deliver treatment to patients in an outpatient setting while avoiding the extensive manufacturing delays associated with autologous CAR-T therapies. We look forward to reporting full study results from the phase 1 cohort and moving toward a recommended phase 2 dose. We continue to advance our innovative cell therapies such as PD-L1.t-haNK in combination with ImmunityBio’s N-803, an IL-15 superagonist that is designed to stimulate the activation and proliferation of the patient’s own NK cells to maximize the potential of immunogenic cell death to treat cancer," continued Soon-Shiong. NantKwest and a wholly owned subsidiary of ImmunityBio have entered into an exclusive collaboration agreement to co-develop NantKwest’s proprietary off-the-shelf NK platforms in combination with N-803.

On December 2, 2019 at the NantKwest Key Opinion Leader and Investors conference, Dr. Soon-Shiong described the clinical development plans for two of NantKwest’s first-in-class NK products: haNK, which was developed to target binding to approved monoclonal therapies such as Trastuzumab, Rituximab and Cetuximab; and PD-L1.t-haNK, which was also designed to target these approved therapies plus directly target PD-L1-expressing tumor cells.

PD-L1.t-haNK cells are a human-derived, allogeneic, natural killer cell line engineered to express a chimeric antigen receptor (CAR) targeting PD-L1, whose origins arise from NantKwest’s proprietary NK-92 (aNK) master cell bank. In addition to targeting PD-L1, PD-L1.t-haNK is engineered to produce intracellular IL-2 for enhanced CD16-targeted antibody-dependent cellular cytotoxicity capabilities.

John Lee, M.D., Clinical Senior Vice President at NantKwest, said, "We are highly encouraged by the early safety results with PD-L1.t-haNK in a patient population with advanced, difficult to treat solid tumors. All patients were able to be infused in the outpatient setting without any reported cytokine toxicities or immune related adverse events. NantKwest’s approach has been designed to overcome the challenges and limitations typically seen when treating solid tumors with CAR-T and other immunotherapy approaches and I look forward to progressing our studies to advance this innovative new approach to cancer therapy."

Study Design

The QUILT-3.064 study is an open-label, Phase 1 study of PD-L1.t-haNK in subjects with locally advanced or metastatic solid cancers to evaluate safety, preliminary efficacy, determine maximum tolerated dose (MTD) or highest tolerated dose (HTD) and designate the recommended Phase 2 dose (RP2D). The study is being conducted in two parts: the first is evaluating dose escalation using a 3 + 3 design and the second part will evaluate the expansion of the recommended Phase 2 dose (RP2D) to further assess the safety and efficacy of PD-L1.t-haNK therapy. In part one, six subjects were sequentially enrolled, starting at dose level 1 and assessed for dose-limiting toxicities. The primary study objectives are to determine the MTD or HTD, RP2D (recommended phase 2 dose), and safety. The secondary endpoints include objective response rate (ORR), progression free survival (PFS) and overall survival (OS). More information can be found at ClinicalTrials.gov, Identifier: NCT04050709.