On October 15, 2019 ViewRay, Inc. (NASDAQ: VRAY) reported preliminary results for the third quarter 2019 (Press release, ViewRay, OCT 15, 2019, View Source [SID1234542281]). The preliminary results have not been audited and are subject to change.

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Selected Third Quarter Preliminary Results:

Total revenue of $20.9 million in the third quarter of 2019, primarily from three revenue units, compared to total revenue of $17.7 million, primarily from three revenue units, in the third quarter of 2018.
Received 8 new orders for MRIdian systems, including 3 upgrades, totaling approximately $35 million in the third quarter of 2019, compared to orders totaling approximately $36 million in the third quarter of 2018.
Total backlog grew to approximately $231 million as of September 30, 2019.
Cash and cash equivalents were approximately $92 million as of September 30, 2019.
The Company reaffirmed its full year 2019 guidance of revenue in the range of $80-95 million, and cash use in the range of $80-90 million.
"I am pleased with the progress our team is making on the commercial, clinical, and innovation fronts," said Scott Drake, President and CEO. "With our customers, we are driving a paradigm shift in how radiation therapy is delivered and treating patients that, without MRIdian, had no other treatment options. Customers ranging from large academic centers to free-standing clinics are responding to our value proposition. We look forward to discussing our third quarter results on our November earnings call."

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Tuesday, November 12, 2019 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525 -7129 for international callers. The conference ID number is 8250536. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at www.viewray.com.

After the live webcast, a replay of the webcast will remain available online on the investor relations page of ViewRay’s corporate website, www.viewray.com, for 14 days following the call. In addition, a telephonic replay of the call will be available until November 19, 2019. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 8250536.

On October 15, 2019 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that the Company will host a webcast conference call to report its third quarter 2019 financial results and provide an update on the company’s business and outlook on Tuesday, October 29, 2019 at 4:30 p.m. (ET) after closing of the market (Press release, PTC Therapeutics, OCT 15, 2019, https://www.prnewswire.com/news-releases/ptc-therapeutics-to-host-conference-call-to-discuss-third-quarter-2019-financial-results-300938644.html [SID1234542280]).

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The call can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 9224968. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for two weeks.

On October 15, 2019 Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, reported FDA’s approval to initiate Denovo’s Phase 2b clinical study of DB102 in patients with newly-diagnosed glioblastoma (GBM) in combination with radiation and temozolomide (Press release, Denovo Biopharma, OCT 15, 2019, View Source [SID1234542279]).

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Denovo’s GBM clinical study is an extension of its work to identify a genetically-enriched patient population with DLBCL who may benefit from DB102 treatment. After Denovo acquired DB102 from Eli Lilly & Co., it discovered a novel genetic biomarker, DGM1, that is a potentially predictive biomarker for DB102 response in patients with DLBCL. Since DGM1 is a germline biomarker, Denovo found that DGM1 also predicts a survival benefit in patients with GBM treated with DB102 plus temozolomide. Denovo’s clinical trial is expected to enroll approximately 200 patients with newly-diagnosed GBM.

"GBM remains one of the toughest cancers to treat and numerous attempts have failed including anti-PD-1 antibodies. DB102 treatment guided by the novel DGM1 biomarker could potentially provide a breakthrough for this severely unmet medical need," said Lei Zhang, M.D., Denovo Biopharma’s Chief Medical Officer. "We are very excited to receive FDA’s approval of our IND and begin to initiate this potentially pivotal GBM study."

About Glioblastoma

Glioblastoma Multiforme (GBM) is the most common type of adult primary malignant brain cancer, with 18,000 newly-diagnosed patients in the US and 13,000 deaths annually. Standard treatment for patients with newly diagnosed GBM can include surgery followed by radiation and chemotherapy, but treatment options are limited. The five-year survival rate of patients with GBM is less than five percent.

On October 15, 2019 Aetion and McKesson reported a strategic collaboration focused on advancing the use of real-world evidence (RWE) in cancer research to benefit patients, regulators, the biopharma industry, and payers (Press release, McKesson, OCT 15, 2019, View Source [SID1234542278]). The partnership will provide best-in-class solutions in multiple tumor types, including breast, lung, and melanoma cancers.

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The joint solutions combine the Aetion Evidence Platform with data from McKesson’s iKnowMedSM oncology electronic health record (EHR) system to power regulatory-grade outcomes research. They will first be made available to the team of researchers at Brigham and Women’s Hospital who are leading the Food and Drug Administration (FDA) demonstration project, RCT DUPLICATE, in order to replicate oncology randomized controlled trials (RCTs) with real-world data. Aetion and McKesson are also both part of the Friends of Cancer Research Real-World Evidence pilot project to assess several frontline treatment regimens in real-world patients with advanced non-small cell lung cancer (aNSCLC), which will inform the FDA’s acceptance of real-world evidence for drug approvals.

"This collaboration is an important step in informing rigorous standards for regulatory-grade data and analysis. Our goal is to get therapies to market faster to help life sciences companies and drive better health for patients," said Derek Rago, vice president and general manager of Oncology Data, Evidence, and Insights at McKesson Life Sciences. "Based on the ability of observational studies to gain insight into treatment patterns and outcomes in clinical practice, the FDA is supportive of the expanded use of RWE to inform a variety of regulatory decisions."

The solutions allow users to conduct regulatory-grade studies in major cancers and accelerate time to insight on oncology data. It also enables researchers to develop evidence for synthetic control arm and label expansion studies, to fulfill post-marketing safety requirements, and to assess the economic impact of treatments.

"Combining our real-world evidence platform with McKesson’s cancer data accelerates time to insight when conducting oncology analyses," said Carolyn Magill, CEO of Aetion. "This collaboration enables us to provide researchers with the tools to advance cancer research with greater efficiency and precision."

McKesson’s iKnowMed was named the top-ranked EHR platform for oncologists and hematologists for the eighth year in a row by Black Book Research and is ONC Health IT certified. By joining Aetion’s scientifically-validated RWE platform with McKesson’s best-in-class data, the offering enables faster and more cost-effective regulatory-grade cancer research.

Expanding the possibilities for cost-effective cancer research through RWE meets a pressing need. In 2018, biopharma invested $50 billion to support oncology research and development, with an approximate three percent probability of success for any individual product. Real-world evidence can provide critical information about treatments while reducing the costs and time of developing a drug.

On October 15, 2019 Abalos Therapeutics reported a EUR 12 million Series A financing round establishing its operations and leadership (Press release, Abalos Therapeutics, OCT 15, 2019, View Source [SID1234542275]). The Company’s objective is to develop new immuno-oncology therapeutics based on a specific arenavirus strain that preferentially infects and proliferates in cancer cells generating a strong anti-tumor immune response. The Series A round was co-led by Boehringer Ingelheim Venture Fund (BIVF) and Gruenderfonds Ruhr, with participation from NRW.BANK and High-Tech Gruenderfonds (HTGF). Representatives from all investors will join the company’s newly formed Supervisory Board.

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Concurrent with the financing, Abalos announced the appointment of experienced entrepreneurs Dr. Marcus Kostka as Chief Executive Officer and Dr. Jörg Vollmer as Chief Scientific Officer.

"Abalos’ goal is to capture the potent immune activation and highly specific tumor tropism of the arenavirus to propel a differentiated immuno-oncology approach towards clinical evaluation," said Dr. Marcus Kostka, CEO of Abalos Therapeutics. "After funding and supporting a range of biotechnology companies over the years, this promising technology and the chance to build a company with Jörg as a highly-experienced immunology expert made this opportunity extremely attractive."

The proceeds from the financing will be used to advance Abalos’ arenavirus-based lead candidates towards clinical testing. The Company will develop the initial product candidates using its proprietary Fast Evolution platform, which will generate virus strains with optimized anti-tumoral properties. These candidates will be selected based on their ability to re-program the immune system to specifically and efficiently eliminate the malignant tumor tissue. The approach is based on the innovative research of immunologists Prof. Dr. Karl Lang, Chair of Immunology at the Medical Faculty, University Duisburg-Essen and Prof. Dr. Philipp Lang, Director of the Department of Molecular Medicine II, University Düsseldorf. Abalos builds on a close collaboration with the Universities Duisburg-Essen and Düsseldorf.

Dr. Aristotelis Nastos from Gruenderfonds Ruhr commented: "Immuno-oncology continues to make very exciting progress, however, developing drug candidates that can more fully harness the power of the immune system remains a challenge, in particular, addressing not only the main tumor but also distant metastases. We look forward to supporting Abalos’ experienced management team and its dedicated researchers to work on an arenavirus-based solution."

Dr. Marcus Kostka is a highly seasoned industry expert bringing over 20 years and a range of experiences from Boehringer Ingelheim (BI), where he held positions defined by the ability to locate and advance innovation. Most recently, he was Venture Fund Partner at BI and held board positions at several companies and participated in the successful exits of Rigontec and ICD Therapeutics.

In his role as CSO, Dr. Jörg Vollmer brings to Abalos Therapeutics significant knowledge and experience in the areas of immunology, oncology and infectious diseases, which he obtained in various R&D and executive positions over the course of his career. Most recently, Jörg was CSO at Rigontec where he helped advance a novel immuno-oncology treatment approach into the clinic and led the company’s R&D efforts until the acquisition by MSD in 2017.