ViewRay Announces Preliminary Fourth Quarter and Full Year 2020 Results

On January 4, 2021 ViewRay, Inc. (NASDAQ: VRAY) reported preliminary results for the fourth quarter and full fiscal year ended December 31, 2020 (Press release, ViewRay, JAN 4, 2021, View Source [SID1234573449]). The preliminary results have not been audited and are subject to change.

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Selected Fourth Quarter and Full Year 2020 Preliminary Results and Other Data (Unaudited):

Total revenue of approximately $18 million in the fourth quarter of 2020, primarily from three revenue units including one system upgrade, compared to total revenue of approximately $17 million, primarily from three revenue units including one system upgrade, in the fourth quarter of 2019.
Received five new orders, including one upgrade, for MRIdian systems totaling approximately $24 million in the fourth quarter of 2020, compared to four new orders totaling approximately $21 million in the fourth quarter of 2019.
Full year 2020 revenue of approximately $57 million, primarily from nine revenue units, including two system upgrades, compared to 2019 revenue of approximately $88 million, primarily from 15 revenue units, including two system upgrades.
Total backlog was approximately $241 million as of December 31, 2020.
Cash and cash equivalents were approximately $157 million as of December 31, 2020. Cash burn in the fourth quarter of 2020 was approximately $7 million.
"While the COVID-19 pandemic impacted our business in 2020, we closed the year with a solid Q4. We are pleased with the progress made on our clinical and innovation pipelines. We preserved capital and concurrently moved our business forward. MRIdian’s clinical, strategic, and economic value propositions are resonating with customers, and we are encouraged by our commercial pipeline activity," said Scott Drake, President and CEO. "In Q4 we received five MRIdian orders and used approximately $7 million of cash. We meaningfully reduced our cash use as compared to 2019, and we expect to continue to reduce our burn moving forward. Our product pipeline is focused on faster treatment times, improved workflow and efficiency, and cost reduction. Our innovation pipeline, combined with continued compelling clinical evidence, positions us for broader therapy adoption as we strive to improve the lives of cancer patients worldwide."

Our estimated unaudited financial results and certain business metrics as of and for the fourth quarter and full fiscal year ended December 31, 2020 presented above are preliminary and are subject to the close of the quarter and year, completion of our quarter-end and year-end closing procedures and further financial review. Our independent registered public accounting firm has not audited, reviewed, compiled or performed any procedures with respect to this preliminary financial information. Our actual results may differ from these estimates as a result of the completion of our quarter-end and year-end closing procedures, review adjustments and other developments that may arise between now and the time our financial results for the fourth quarter and year are finalized.

PTC Therapeutics to Present at the 39th Annual J.P. Morgan Healthcare Conference

On January 4, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that management will present a company update at the 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11th at 7:30 a.m. EST (Press release, PTC Therapeutics, JAN 4, 2021, View Source [SID1234573448]).

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The presentation will be webcast live on the Events and Presentations page under the investor relations section of PTC Therapeutics’ website at www.ptcbio.com and will be archived for 30 days following the presentation. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection.

Poseida Therapeutics to Participate in SternIR Virtual Corporate Access Event

On January 4, 2021 Poseida Therapeutics, Inc. (NASDAQ: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary gene engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported that Eric Ostertag, M.D., Ph.D., Poseida Therapeutics’ Chief Executive Officer, will participate in a pre-recorded presentation through the SternIR Virtual Corporate Access Event taking place from January 11-14, 2021 (Press release, Poseida Therapeutics, JAN 4, 2021, View Source [SID1234573447]). In addition, management will be available for one-on-one meetings with investors.

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The presentation will be available for on-demand viewing on the Investors & Media Section of the Poseida website, www.poseida.com, beginning Monday, January 11, 2021 at 7:00 a.m. ET and will be available for approximately 30 days.

Johnson & Johnson Announces Quarterly Dividend for First Quarter 2021

On January 4, 2020 Johnson & Johnson (NYSE: JNJ) reported that its Board of Directors has declared a cash dividend for the first quarter of 2021 of $1.01 per share on the company’s common stock (Press release, Johnson & Johnson, JAN 4, 2021, View Source;johnson-announces-quarterly-dividend-for-first-quarter-2021-301200054.html [SID1234573446]). The dividend is payable on March 9, 2021 to shareholders of record at the close of business on February 23, 2021. The ex-dividend date is February 22, 2021.

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Bioniz Announces Positive End of Phase 2 Meeting with the FDA for BNZ-1 for the Treatment of Refractory Cutaneous T-Cell Lymphoma

On January 4, 2021 Bioniz Therapeutics, Inc., ("Bioniz"), a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine inhibitors for the treatment of cancer and autoimmune diseases, reported today that the U.S. Food and Drug Administration (FDA) provided positive feedback during the company’s end of Phase 2 (EOP2) meeting for Bioniz’s BNZ-1 (Press release, Bioniz Therapeutics, JAN 4, 2021, View Source [SID1234573445]). Based on the FDA’s feedback, Bioniz intends to initiate a Phase 3 clinical trial of BNZ-1 for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (rCTCL). The FDA provided clear guidance for the design of the BNZ-1 Phase 3 trial as well as submission of the New Drug Application (NDA) that would follow a successful pivotal trial. Bioniz expects the Phase 3 to begin enrolling second half of 2021. BNZ-1 has previously been granted orphan designation by the FDA.

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"The successful completion of our end of Phase 2 meeting with the FDA for BNZ-1 is another key milestone for this drug, which is the lead candidate from our platform of novel multi-cytokine inhibitors designed to treat cancer and autoimmune diseases driven by unregulated T-cell biology," said Dr. Nazli Azimi, Founder, President, and CEO of Bioniz Therapeutics and co-inventor of BNZ-1. "Based on the feedback from the FDA and the data from our recently completed Phase 1/2 clinical study, we believe BNZ-1 can be a major advancement in helping CTCL patients stabilize their disease without significant and treatment-limiting side effects."

Bioniz recently reported positive clinical data in an oral presentation at the 62nd ASH (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2020) from the company’s Phase 1/2 clinical study of BNZ-1 for the treatment of patients with rCTCL, a rare, aggressive cancer. BNZ-1, a novel immuno-modulator drug candidate, is a multi-cytokine inhibitor of three interleukins (IL-2, IL-9, and IL-15) and is the lead asset from the company’s platform of first-in-class peptide therapeutics that selectively and simultaneously inhibits multiple cytokines to treat cancer and autoimmune diseases.

About Refractory Cutaneous T-cell Lymphoma (rCTCL)
Cutaneous T-cell lymphomas (CTCLs) are a rare, aggressive, heterogeneous group of non-Hodgkin’s lymphomas that manifest primarily in the skin. Although a wide array of therapeutic options are available for early-stage CTCL, not all patients respond, resulting in refractory CTCL (rCTCL) with limited treatment options and a poor prognosis.

About BNZ-1
The company’s lead product candidate, BNZ-1, is a selective inhibitor of cytokines IL-2, IL-9, and IL-15, which are potent T-cell growth factors and key disease drivers in CTCL. Bioniz is also evaluating BNZ-1 for the treatment of autoimmune diseases, including alopecia areata and vitiligo, which are also driven by unregulated T-cell biology.