On April 11, 2019 ViewRay, Inc. (Nasdaq: VRAY) reported details relating to the release of its first quarter 2019 financial results (Press release, ViewRay, APR 11, 2019, View Source [SID1234535108]).

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ViewRay will hold a conference call to discuss results on Thursday, May 2, 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 8616638. 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 May 9, 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 8616638.

On April 11, 2019 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, reported that it has commenced an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and Class A warrants to purchase its common stock (Press release, X4 Pharmaceuticals, APR 11, 2019, View Source [SID1234535107]). All of the securities in the offering will be sold by X4. 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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Cowen and Stifel are acting as joint book-running managers and representatives of the underwriters for the offering. Canaccord Genuity is acting as lead manager of the offering.

The offering will be made only by means of a written prospectus and related prospectus supplement forming part of a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission (SEC) on January 25, 2019 and declared effective by the SEC on February 19, 2019. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available at the SEC’s website located at www.sec.gov, copies of which may be obtained, when available, from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or by telephone at 631-274-2806, and from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, or by telephone at 415-364-2720 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On April 11, 2019 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company reported full year 2018 financial results (Press release, MEDIAN Technologies, APR 11, 2019, View Source [SID1234535106]). Median Technologies Board of Directors approved the consolidated 2018 financial statements on April 10, 2019. The annual shareholders meeting will take place on June 26, 2019.

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As of December 31, 2018, the Company’s order backlog was €23.7m, an increase of 10.8% compared to the backlog on June 30, 2018. During the second half of the year, Median signed up many of the leading Chinese pharmaceutical companies, including major contracts for phase III clinical trials. At the end of 2018, 39.2% of the order backlog was coming from Chinese business compared to 5.4% in 2017.

As of December 31, 2018, the Company’s cash and cash equivalents were €12.7m. The Company’s strategic restructuring into two business units and an increased focus of the iCRO activity on high growth and profitable markets has enabled the cash burn to decrease substantially. During the second semester of 2018 the cash burn was €5.8m versus €9.8m during the first semester of 2018. Excluding exceptional charges related to the Company’s organizational changes, the cash burn would have decreased even more.

As of December 31, 2018, the Company’s revenue was €6.3m, a decrease of 17.5% compared to 2017. Company revenues were entirely generated by the iCRO business unit, which delivers solutions and services for medical image management in oncology clinical trials; the iBiopsy business unit is not generating revenues at this stage, as it currently includes only Research and Development activities. The restructuring of the iCRO business unit has allowed the Company to significantly reduce costs and improve its operational margins.

"In 2018 we repositioned our iCRO business to allow Median to deliver on its promise of sustained profitable growth. We expect strong growth in the coming years, particularly in China and the rest of the Asia-Pacific region", said Fredrik Brag, CEO and co-founder of Median Technologies. "We have focused our R&D effort on the development of our imaging phenomics platform iBiopsy. Through the application of cutting-edge AI technologies, our mission is to contribute to medical innovation and the development of new therapies, and to enable clinical decision making for precision and predictive medicine", Fredrik Brag added.
2018: iCRO business development in China, iBiopsy R&D effort strengthening

2018 was a year of successful transition that has led to the organization of the Company into two separate business units, the iCRO business unit delivering services for image management in oncology clinical trials, and the iBiopsy business unit. The Company focused its iCRO activities principally on the Chinese market while pursuing new business development strategies for the US and Europe. The Company invested further in its R&D activities for iBiopsy, its groundbreaking imaging phenomics platform.

iCRO: The Chinese clinical trial market is experiencing strong growth given that Chinese pharmaceutical companies have been able to raise substantial amounts of funding and have had successful IPO’s. Median has benefited in China from the fact that there are no legacy or established relationships with local or International iCROs competing with the Company. Median has experienced strong market penetration by demonstrating a high quality of customer services. As far as the US and EU markets are concerned, Median has reverted to a more cost-efficient indirect sales model based on its existing partnerships and informal collaborations with global CROs as well as repeat business from existing customers.

iBiopsy: In 2018, Median focused its R&D effort on its next generation imaging phenomics platform iBiopsy. The platform integrates cutting edge Artificial Intelligence and image interpretation technologies and addresses the entire patient journey, from the development of next generation patient diagnosis to novel therapies and treatments based on precision and predictive medicine. As of December 31, 2018, the iBiopsy business unit represented more than 40% of the Company’s overall headcount, the majority of the business unit’s headcount being scientists specialized in image processing, Artificial Intelligence and data sciences, as well as software developers.

Median’s focus on high growth markets and high potential activities led to a reduction in headcount: as of December 31, 2018, the Company’s headcount totaled 78 compared to 117 as of December 31, 2017. Staff costs reflected this decrease. At the same time, external costs increased due to exceptional costs related to the Company reorganization. The Company reported an operating loss of €15.39m and a net loss of €15.28m, down 11.2% compared to 2017 figures.

2019: breakeven iCRO business, an ambitious iBiopsy roadmap

iCRO: The iCRO business should experience continued growth through the conversion of its increasing order backlog and its positioning in the Chinese market. Median is targeting breakeven in 2019 for this part of the business and will focus on establishing a China based entity delivering operations and services for Chinese customers through its WFOE (Wholly Foreign Owned Enterprise) created in 2018 in Shanghai.

iBiopsy: In December 2018, Median appointed Dr. Nozha Boujemaa as Chief Science and Innovation Officer. Nozha Boujemaa took office at the beginning of 2019 and joined the executive committee of Median Technologies. As a Key Opinion Leader in the field of Artificial Intelligence and data sciences, Nozha Boujemaa oversees Median’s scientific vision as well as innovation and development strategies for iBiopsy. Median’s academic and industry-related partnership policy for iBiopsy is also under her responsibility.

Nozha Boujemaa’s experience and deep knowledge of the latest AI technologies are valuable assets and will help define and implement strong technological differentiators for iBiopsy according to its clinical objectives, especially in immuno-oncology. The 2019 iBiopsy roadmap includes a set of technical validations leading to the production of a prototype at the end of the year. Clinical validation, prototype deployment and early adopter selection will commence in 2020.

Median informs its shareholders and the financial community that its annual financial report on the accounts for the year ended December 31, 2018 was made public and filed with the AMF.
The annual financial report is available on the company website: www.mediantechnologies.com/investors/

Forward-Looking Statements: This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Median’s management believes that the expectations reflected in such forward looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities such as the absence of guarantee that the service if approved will be commercially successful, the future approval, Median’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property, trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the AMF made by Median, other than as required by applicable law, Median does not undertake any obligation to update or revise any forward-looking information or statements.

On April 11, 2019 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, reported the formation of a new Immuno-Oncology Advisory Board (IOAB), consisting of several world-recognized and credentialed experts in the fields of immuno-oncology, tumor biology, vaccinology, cell therapy, and precision medicine (Press release, Sensei Biotherapeutics, APR 11, 2019, View Source [SID1234535105]). The IOAB will collaborate closely with members of Sensei’s management team to support the advancement of the Company’s pipeline of ASPH-targeted precision immuno-oncology therapies and bring complementary expertise to guide the future of the company.

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"We are honored to have such a highly distinguished team of experts in the field of immune-oncology join our newly formed advisory board," said John Celebi, Chief Executive Officer of Sensei. "Each of these appointees is globally recognized for their work. We look forward to working closely with them as we continue to develop our suite of novel therapies against next generation targets, including ASPH, and work to profoundly impact the health and quality of life for patients with unmet needs."

The members of the Sensei’s IOAB include:

Alain Algazi, M.D., is an oncologist and Associate Professor at The University of California San Francisco Helen Diller Family Comprehensive Cancer Center. Dr. Algazi conducts clinical trials on personalized medical therapies for patients with head and neck and high-risk skin cancers, in addition to serving as the leader of the head and neck medical oncology research program at UCSF. Dr. Algazi has served as the national study chair for several pivotal trials in oncology and is a member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), and the American Association for Cancer Research (AACR) (Free AACR Whitepaper). He also served previously as a member of The National Comprehensive Cancer Network Melanoma Panel.
Saar Gill, M.D., Ph.D., is an Assistant Professor of Medicine at the University of Pennsylvania, where his clinical practice is bone marrow transplantation. His laboratory studies novel approaches to produce effective and safe CAR T cells for the treatment of hematologic malignancies and CAR macrophages for the treatment of solid cancers. Dr. Gill is a scientific committee member at the American Society of Gene & Cell Therapy (where he is a recent past Chair of the Cancer Gene and Cell Therapy committee) and at the American Society of Hematology (ASH) (Free ASH Whitepaper), and he was recently elected to the American Society of Clinical Investigation.
Sara Pai, M.D., Ph.D., is an Associate Professor of Surgery at Harvard Medical School and an Associate Surgeon and Director of Translational Research in Head and Neck Cancer at Massachusetts General Hospital. She leads several immunotherapy trials in head and neck cancer patients. Dr. Pai’s research interests focus on understanding mechanisms of immune evasion utilized by the human papillomavirus (HPV) and evaluates novel ways to reactive the host immune response against the virus as it relates to cancer cells. Dr. Pai is recognized both nationally and internationally as an expert in HPV-associated head and neck cancers and cancer immunotherapy, in addition she has a research laboratory that is supported by the National Institutes of Health (NIH) as well as industry.
Robert Pierce, M.D., is the Scientific Director of the Immunopathology Lab in the Clinical Research Division at the Fred Hutchinson Cancer Research Center. Dr. Pierce is an Anatomic Pathologist with a strong academic and industry background in immuno-oncology. He was previously the Chief Scientific Officer of OncoSec. His research is focused on the mechanisms of tumor-induced immune tolerance and has longstanding expertise in the development of biomarkers to predict responses to immuno-oncology treatments. While at Merck, Dr. Pierce led a team focused on the development of tissue-based biomarkers for Merck’s anti-PD- 1 therapeutic antibody (pembrolizumab; KEYTRUDA) and was the medical lead responsible for kicking-off the clinical trials of pembrolizumab in Merkel cell carcinoma and mycosis fungoides.
Robert Schreiber, Ph.D., is an Andrew M. Bursky and Jane M. Bursky Distinguished Professor of Pathology and Immunology, Professor of Molecular Microbiology, co-leader of the tumor immunology program at the Siteman Comprehensive Cancer Center and founding Director of the Center for Human Immunology and Immunotherapy Programs at The Washington University School of Medicine in St. Louis, Missouri. Dr. Schreiber is recognized globally as a pioneer in efforts to understand how the immune system may be useful in battling cancer. His research interests include the molecular and cellular basis of cancer immunoediting (a process that he discovered whereby the immune system protects against cancer development and shapes tumor immunogenicity), the biology and signaling of cytokines with special emphasis on IFN-gamma and TNF, as well as the role of IFN-gamma in tumor immunity. He has served in leadership roles for many international organizations. His has achieved multiple honors, including the 2017 Balzan Prize for Immunological Approaches in Cancer Therapy, membership in the National Academy of Sciences (US), the American Academy of Arts and Sciences, the Cancer Research Institute’s Coley Award for Distinguished Research in Basic Tumor Immunology and the AACR (Free AACR Whitepaper)-CRI Lloyd J. Old Award in Cancer Immunology.
Daniel H. Sterman, M.D., is the Thomas and Suzanne Murphy Professor of Pulmonary and Critical Care Medicine in the Departments of Medicine and Cardiothoracic Surgery at the New York University School of Medicine, and Director of the Division of Pulmonary, Critical Care, and Sleep Medicine and Director of the Multidisciplinary Pulmonary Oncology Program at NYU Langone Health in New York City. He was previously lead clinical investigator in the multidisciplinary Thoracic Oncology Research Group at the Perelman School of Medicine at the University of Pennsylvania and the Principal Investigator of the Clinical Trials Project for the NCI. Dr. Sterman’s research interests are related to the treatment of thoracic malignancies, specifically as they apply to the synergy of molecular medicine, tumor immunotherapy and novel technologies in Interventional Pulmonology. Over the past 20 years, he has focused on the translation of laboratory discoveries from the bench to the bedside: conducting multiple human clinical trials of gene therapy and vaccine therapy for lung cancer, mesothelioma, and other pleural malignancies. More recently, as Director of the NYU PORT (Pulmonary Oncology Research Team), Dr. Sterman has expanded his research interests into assessment of the immune microenvironment of tumor-draining lymph nodes, as well as the development of local intra-tumoral and intra-nodal immunotherapies.

On April 11, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer management decisions, reported publication of an independent, prospective study of 159 patients with cutaneous melanoma showing that the DecisionDx-Melanoma gene expression profile (GEP) test accurately identified risk of melanoma recurrence independent of other prognostic factors such as Breslow thickness and sentinel lymph node biopsy (SLNB) result (Press release, Castle Biosciences, APR 11, 2019, View Source [SID1234535104]). The study was published in the journal Cancer Medicine and is consistent with previously published prospective and retrospective studies demonstrating the high performance of DecisionDx-Melanoma to predict outcomes, supporting its clinical value to inform patient management decisions.

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"In this prospective study with 3.5 years of overall follow up, DecisionDx-Melanoma was shown to be an independent prognostic factor that is additive to traditional staging factors," commented lead study investigator Eddy C. Hsueh, M.D., Professor and Director, Division of General Surgery, St. Louis University Hospital. "Accurate risk assessment for cutaneous melanoma is increasingly important to inform patient management decisions including surveillance, follow-up and potential adjuvant therapy consideration."

Patients from this academic center who were diagnosed with cutaneous melanoma received both the DecisionDx-Melanoma test and SLNB as part of their initial work-up. The median tumor Breslow thickness was 1.4 mm and 24% of patients had ulcerated tumors. Sixty percent of patients had American Joint Committee on Cancer (AJCC) Stage I melanoma, 25% had Stage II melanoma and 15% had Stage III melanoma. Patients were followed at regular intervals with an overall median follow-up time of 3.7 years for patients who did not experience an event.

Key Results:

117 patients had a Class 1 (low risk) DecisionDx-Melanoma test result; 42 patients had a Class 2 (high risk) test result.
139 patients had a negative SLNB result; 20 patients had a positive SLNB result.
29 patients experienced a recurrence. Of those who experienced recurrence, 23 (79%) were classified as high risk (Class 2) by DecisionDx-Melanoma. Ten patients who experienced recurrence (34%) had a positive SLNB result and 19 (66%) had a negative SLNB result. Nine of 10 patients who were high risk by both assessments (positive SLNB result and Class 2 result) experienced recurrence.
The negative predictive value (NPV) of a Class 1 result was 95% for recurrence and 99% for distant metastasis. Sensitivity of a Class 2 result was 79% for recurrence and 94% for distant metastasis.
The 3-year recurrence-free survival (RFS) rate for patients with a Class 1 result was 96.6%, significantly higher than the RFS of 47.4% for those with a Class 2 result (p<0.0001).
The 3-year distant metastasis-free survival (DMFS) rate for patients with a Class 1 result was 99.1%, significantly higher than the DMFS of 64.1% for those with a Class 2 result (p<0.0001).
DecisionDx-Melanoma was the most significant predictor of recurrence (Class 2 hazard ratio=9.2, p=0.0001) and distant metastasis (Class 2 hazard ratio=19.0, p=0.009) risk in multivariate analysis comparing to age, Breslow thickness, ulceration and SLNB result.
The full published study results can be accessed at the journal’s website.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors and has been studied in over 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multicenter studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in five prospective studies including over 780 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,470 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter study cohorts that included over 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multicenter and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.