On August 2, 2022 Envisagenics, Inc., a New York-based biotechnology company leveraging artificial intelligence (AI) and RNA-splicing analytics for discovery and development of disease specific therapeutics, reported that it was awarded a Small Business Innovation Research (SBIR) Direct to Phase II grant from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) (Press release, Envisagenics, AUG 2, 2022, View Source [SID1234617315]). This grant will provide $2 million over 2 years to commercialize Envisagenics’ proprietary drug discovery platform, SpliceIOTM, for the discovery of novel targets for immuno-oncology (IO) therapeutic development. SpliceIO is one of the latest AI drug discovery platforms developed by Envisagenics, which complements the SpliceCore platform for the discovery of splicing drug targets using RNA-seq data.

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"What the SpliceCore platform does for antisense drugs, SpliceIO is doing for IO drugs. SpliceIO discovers splicing-derived neoantigens for immunotherapies using RNA-seq data as a sole input," said Martin Akerman, Ph.D., Chief Technology Officer and Co-founder of Envisagenics. "This funding will help scale Envisagenics’ target pipeline by enabling validation of IO targets at the protein level, a critical step for advancing candidate targets to the next stage of development."

Envisagenics will apply its platform to identify splicing-derived neoantigens in BRCA1/2 carriers at-risk for developing breast cancer and develop a high-throughput approach to validate its findings using proteomic data. Within the scope of this grant, Envisagenics will collaborate with researchers at Northwestern University Feinberg School of Medicine: Dr. Seema Khan (Co-Leader of the Cancer Prevention Program of the Lurie Comprehensive Cancer Center and Bluhm Family Professor of Cancer Research) and Dr. Susan Clare (Research Associate Professor of Surgery). "We are excited to collaborate with Envisagenics to apply its innovative technology leveraging splicing analytics for neoantigen discovery in BRCA1/2 carriers, an exemplar population for prophylactic intervention, given their high risk of developing breast or ovarian cancers, and the increasing recognition that immune interventions are particularly appropriate in the cancer prevention arena," said Dr. Khan.

Envisagenics was previously awarded Phase I and Phase II grants from the National Institute of General Medical Sciences (NIGMS, NIH) to develop the SpliceCore software platform. A Phase I SBIR grant was also awarded by the NCI to expand SpliceCore’s capabilities for discovery of splicing-derived neoantigens. "We are grateful for the NIH’s continued support of innovative technologies and enabling AI-driven biotechnology companies like Envisagenics to continue to develop next generation technologies to accelerate the discovery and development of therapies for patients in need," said Maria Luisa Pineda, Ph.D., Chief Executive Officer and Co-founder of Envisagenics.

On August 2, 2022 Perrigo Company plc (NYSE: PRGO), a leading global provider of Consumer Self-Care Products, reported that its Board of Directors declared a quarterly dividend of $0.26 per share, payable on September 20, 2022, to shareholders of record on September 2, 2022 (Press release, Perrigo Company, AUG 2, 2022, View Source [SID1234617314]).

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On August 2, 2022 Amgen (NASDAQ: AMGN) reported that it will host a webcast call for the investment community in conjunction with the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC) at 12:00 p.m. ET on Monday, Aug. 8, 2022 (Press release, Amgen, AUG 2, 2022, View Source [SID1234617313]). David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team, will discuss the data being presented on LUMAKRAS (sotorasib) in combination with immunotherapy and in combination with a SHP2 inhibitor in non-small cell lung cancer, as well as tarlatamab data in small cell lung cancer.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On August 2, 2022 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the second quarter ended June 30, 2022 (Press release, ViewRay, AUG 2, 2022, View Source [SID1234617312]).

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Second Quarter 2022 Highlights

Total revenue for the second quarter 2022 was approximately $22.1 million, primarily from three revenue units and one upgrade, compared to approximately $15.0 million, primarily from two revenue units, in the second quarter of 2021.
Received eight new orders for MRIdian systems totaling $46.3 million, compared to seven new orders totaling $37.9 million in the second quarter 2021.
Total backlog increased to $352.8 million as of June 30, 2022, compared to approximately $278.4 million as of June 30, 2021.
Cash and cash equivalents, inclusive of a customer deposit reflected in restricted cash was $160.7 million as of June 30, 2022. Cash usage for the three months ended June 30, 2022 was approximately $22.5 million.
"Our clinical, innovation, and commercial pipelines have never been stronger and each are accelerating. Business momentum is increasing as rapid revenue growth is translating into significant gross margin expansion. With tight expense discipline, we believe that we have the balance sheet required to get to cash flow breakeven," said Scott Drake, President and CEO. "We also believe that our clinical data and our MRIdian footprint make this the right time to commence targeted market awareness efforts. We’re excited to partner with Katie Couric and her team to spread awareness that short-course, non-invasive treatment with fewer side effects and better quality of life for cancer patients is available today at MRIdian centers."

Three Months Ended June 30, 2022 Financial Results

Total revenue for the three months ended June 30, 2022 was $22.1 million compared to $15.0 million for the same period last year.

Total cost of revenue for the three months ended June 30, 2022 was $21.1 million compared to $16.7 million for the same period last year.

Total gross profit for the three months ended June 30, 2022 was $1.1 million, compared to a gross loss of $1.7 million for the same period last year.

Total operating expenses for the three months ended June 30, 2022 were $30.9 million, inclusive of a $1.8 million impairment charge, compared to $24.8 million for the same period last year.

Net loss for the three months ended June 30, 2022 was $27.6 million, or $(0.15) per share, compared to $31.0 million, or $(0.19) per share, for the same period last year.

ViewRay’s total cash and cash equivalents, inclusive of a customer deposit reflected in restricted cash, was $160.7 million as of June 30, 2022.

Six Months Ended June 30, 2022 Financial Results

Total revenue for the six months ended June 30, 2022 was $41.0 million compared to $30.6 million for the same period last year.

Total gross profit for the six months ended June 30, 2022 was $1.2 million, compared to a gross loss of $1.4 million for the same period last year.

Total operating expenses for the six months ended June 30, 2022 were $58.4 million, inclusive of a $1.8 million impairment charge, compared to $49.8 million for the same period last year.

Net loss for the six months ended June 30, 2022 was $53.4 million, or $(0.30) per share, compared to $57.7 million, or $(0.36) per share, for the same period last year.

Financial Guidance

The Company updated its 2022 guidance of total revenue by raising the bottom end of the range from $84 million to $90 million, while reiterating the top end of the range of $104 million. The Company also reiterated total cash usage to be in the range of $68 million to $83 million.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Tuesday, August 2, 2022 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (646) 307-1952 for domestic callers and (888) 672-2415 for international callers. The conference ID number is 7750966. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available until August 16, 2022. (800) 770-2030 for domestic callers and (609) 800-9909 for international callers. Please use the conference ID number 7750966.

On August 2, 2022 ViewRay, Inc, the U.S. maker of the MRIdian System, reported a partnership with award-winning journalist and cancer advocate Katie Couric’s multi-media company, Katie Couric Media ("KCM") (Press release, ViewRay, AUG 2, 2022, View Source [SID1234617311]). ViewRay and KCM are working together to launch a national awareness campaign to educate patients and clinicians about MRIdian SMART (Stereotactic MRI-guided adaptive radiotherapy) for treatment of pancreatic, prostate, lung, liver, breast, colorectal and oligometastatic cancers.

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Nearly 25,000 patients have been treated by over 50 MRIdian systems, including 21 academic and community hospitals in the United States and nearly 30 other hospitals around the world. These centers are pioneering the use of MRIdian SMART treatments and have demonstrated favorable patient outcomes, including extended survival for pancreatic cancer patients and reduced side effects through shorter course treatments for prostate cancer patients. A list of hospitals using MRIdian is located at: View Source

Couric’s life mission is focused on cancer prevention and research. After her first husband, Jay Monahan, died from colorectal cancer more than two decades ago, Couric bravely got a colonoscopy live on NBC’s Today show, which she cohosted from 1991 to 2006, to raise awareness of colon cancer screenings. The same year, she co-founded the National Colorectal Cancer Research Alliance, and then in 2008, Couric co-founded Stand Up To Cancer (SU2C). Since its launch, SU2C has raised more than $700 million to support cutting-edge collaborative science and its research has contributed to nine new FDA-approved therapies.

"I’m thrilled to announce our new partnership with ViewRay. Their one-of-a-kind technology is enabling clinicians to treat patients with targeted, and effective state-of-the-art MRI-guided radiation therapy. Innovation like this gives me hope for the millions of people around the world currently battling cancer" says Katie Couric.

In 2017, Couric and her husband, John Molner, started Katie Couric Media, a multi-media company that creates high-quality content in collaboration with purpose-driven brands that sparks curiosity, elevates conversation, inspires action and moves the world forward. "With over 5 million subscribers across multiple platforms, our audience at KCM is looking to support companies and brands that are innovative, best in class and striving to make a difference. ViewRay’s vision to conquer cancer by re-envisioning radiation therapy is a perfect example of this," says John Molner, Katie Couric Media’s Co-Founder and CEO.

"Thousands of patients treated on MRIdian prove compelling and consistent clinical outcomes in both tough to treat and more common cancers. Patients demand short-course non-invasive therapy with fewer side effects and better quality of life, whether they face complex or more common forms of cancer. ViewRay is committed to delivering that to every patient who requires treatment," said Scott Drake President and CEO of ViewRay. "Our expanding body of clinical data combined with our footprint of MRIdian systems make this the perfect time to partner with Katie and her team. This campaign is an expression and expansion of our dedication to empower cancer patients and their loved ones to find the hope that resides in the best available care."

The MRIdian system provides oncologists outstanding anatomical visualization through diagnostic-quality MR images and the ability to adapt a radiation therapy plan to the targeted cancer with the patient on the table. This combination allows physicians to define tight treatment margins to avoid unnecessary radiation exposure of vulnerable organs-at-risk and healthy tissue and allows the delivery of ablative radiation doses in five or fewer treatment sessions, without relying on implanted markers. By providing real-time continuous tracking of the target and organs-at-risk, MRIdian enables automatic gating of the radiation beam if the target moves outside the user-defined margins. This allows for delivery of the prescribed dose to the target, while sparing surrounding healthy tissue and critical structures, which results in minimizing toxicities typically associated with conventional radiation therapy.

Disclaimer:
Nothing in this material is intended to provide specific medical advice or to take the place of written law or regulations.

Safety Statement
The MRIdian Linac System is not appropriate for all patients, including those who are not candidates for magnetic resonance imaging. Radiation treatments may cause side effects that can vary depending on the part of the body being treated. The most frequent ones are typically temporary and may include, but are not limited to, irritation to the respiratory, digestive, urinary, or reproductive systems; fatigue; nausea; skin irritation; and hair loss. In some patients, side effects can be severe. Treatment sessions may vary in complexity and duration. Radiation treatment is not appropriate for all cancers. You should discuss the imaging with your doctor to make sure radiation treatment is right for you.