On April 16, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that Translational Cancer published long term analytical performance characteristics of the 80-gene BluePrint molecular subtyping assay (Press release, Agendia, APR 16, 2020, View Source [SID1234556391]).

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Breast cancer is a heterogeneous disease with distinct patient populations who experience different clinical outcomes. Traditionally, these patient groups have been identified by their estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) statuses. Determining a patient’s clinical subtype, either luminal (ER+ and/or PR+), HER2+ or triple negative (ER/PR-, HER2-), via immunohistochemical (IHC) testing is a critical part of the diagnostic workup process to inform treatment planning. As an adjunct to IHC testing, the 80-gene BluePrint molecular subtyping assay goes beyond traditional cell surface markers such as ER, PR and HER2 to determine the underlying pathway driving a tumor’s growth. In combination with MammaPrint, BluePrint categorizes patients into four distinct subtypes, Luminal A-Type, Luminal B-Type, HER2-Type or Basal-Type, to further support treatment planning.

The Translational Cancer publication demonstrated that over a three year period, the BluePrint molecular assay was highly precise and reproducible with correlations above 98% for reported numerical indices and 99% concordance for reported subtype categories. This contrasts with standard IHC and in situ hybridization assays (often used for HER2) which have variability from lab to lab due to challenges with standardization and interpretation of results. In addition to clinical validity and utility, analytical validity and reproducibility are important considerations when adopting testing methods to guide breast cancer treatment.

One of the primary benefits of BluePrint testing is identifying unique patient groups where there is discordance between IHC and molecular subtyping results. For instance, the well characterized ER+ Basal group, ER+ by IHC but Basal by molecular subtyping, has a poorer prognosis than standard ER+ patients. In a French study published by NPJ Breast Cancer and led by Pr. François Bertucci and his colleagues from the Centre de Recherche en Cancérolgie de Marseille, 65% of ER+ Basal patients had a recurrence within 3 years of diagnosis vs. only 44% in the ER+ Luminal group. This study was an in silico analysis of a data set from 36 studies that included 5,342 pathological ER+/HER2- tumors. Overall, the Basal subtype was found to be more closely related to pathologically triple negative breast cancer, yet still distinct.

Dr. Bertucci concluded, "the study results reinforce the potential clinical value of the different molecular classifications in ER+/HER2- breast cancers. The Basal and Luminal subtypes are so different with respect to therapeutic response and metastatic potential that they cannot continue to be assimilated and treated as a homogeneous ER+/HER2- group."

"By clearly understanding the molecular subtype of a patient’s tumor prior to surgery, physicians can use this information to guide treatment decisions and determine which patients will have favorable outcomes with pre-operative chemotherapy and those who would benefit by going directly to surgery," said William Audeh, MD Chief Medical Officer of Agendia.

On April 16, 2020 CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, reported that 2020 first quarter financial results will be released on Thursday, April 30, 2020 after the market closes (Press release, CryoLife, APR 16, 2020, View Source [SID1234556390]). On that day, the Company will hold a teleconference call and live webcast at 4:30 p.m. ET to discuss the results, followed by a question and answer session hosted by Pat Mackin, Chairman, President and Chief Executive Officer of CryoLife, Inc.

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To listen to the live teleconference, please dial 201-689-8261 a few minutes prior to 4:30 p.m. ET. A replay of the teleconference will be available April 30 through May 7, 2020 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The conference number for the replay is 13702193.

The live webcast and replay can be accessed in the Investor Relations section of the CryoLife website at www.cryolife.com and selecting Webcasts & Presentations. In addition, a copy of the earnings press release, which will contain financial and statistical information for the completed quarter and full year, can be accessed in the Investor Relations section of the CryoLife website.

On April 16, 2020 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 4,787,553 shares of the Company’s common stock, at a purchase price of $1.671 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Pulmatrix, APR 16, 2020, View Source [SID1234556389]). Pulmatrix has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 4,787,553 shares of common stock. The closing of the offering is expected to occur on or about April 20, 2020, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $1.55 per share of common stock, will be exercisable immediately following the date of issuance and will expire two (2) years following the date of issuance.

The gross proceeds to Pulmatrix from this offering are expected to be approximately $8.0 million, before deducting the placement agent’s fees and other offering expenses. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Pulmatrix pursuant to a "shelf" registration statement on Form S-3 (File No. 333-230225) previously filed with the Securities and Exchange Commission (the "SEC") on March 12, 2019 and declared effective by the SEC on March 15, 2019. The offering of the securities will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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

On April 16, 2020 Accuray Incorporated (NASDAQ: ARAY) reported that it will report results for its third quarter ended March 31, 2020 on Tuesday, April 28, 2020 after the market close (Press release, Accuray, APR 16, 2020, View Source [SID1234556388]). Management will host a conference call to review the results at 1:30 p.m. PT/4:30 p.m. ET on the same day.

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The conference call dial-in numbers are 877-270-2148 (USA) or 412-902-6510 (International). In addition, a dial up replay of the conference call will be available approximately one hour after the call’s conclusion for one week. The replay number is 877-344-7529 (USA), or 412-317-0088 (International), Conference ID: 10142781.

A live webcast of the call will also be available from the Investor Relations section of the Company’s website at investors.accuray.com. A webcast replay can be accessed on the website and will remain available until Accuray announces its results for the fourth quarter of fiscal 2020.

On April 16, 2020 Synthon Biopharmaceuticals B.V., a biopharmaceutical research and development company creating innovative precision medicines for patients with relentless cancers and autoimmune diseases, reported that it is relaunching as relaunch as Byondis (Press release, Synthon, APR 16, 2020, View Source [SID1234556387]).

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Byondis is creating safe and effective precision medicines based on its proprietary technologies, targeting intractable cancers and auto-immune diseases, which aim to improve the standard of care for patients.

The Company has a broad development pipeline, including advanced clinical programs, such as anti-HER2 ADC [vic-]trastuzumab duocarmazine (SYD985) for breast cancer. In the second half of 2020, Byondis is expecting results from its pivotal TULIP Phase III trial comparing SYD985 to physician’s choice treatment in patients with HER2-positive unresectable locally advanced or metastatic breast cancer. Submission of a Biological License Application is scheduled before the end of 2020.

The Company anticipates entering the clinic with four additional programs in the course of 2020/2021. After progressing to clinical proof of concept, Byondis intends to enter into partnerships for late-stage development and commercialization.

Synthon Biopharmaceuticals was established in 2007 as part of Synthon B.V., and became a separate biopharmaceutical subsidiary in 2012, quickly building a promising pipeline of innovative R&D programs. In November last year, following the acquisition of Synthon International Holding B.V. by BC Partners, the founder, Dr Jacques Lemmens, decided to continue as an independent biopharmaceutical company, with its own management team and state-of-the-art facilities. This company relaunches today as Byondis.

"Our relaunch as Byondis is an exciting moment for the Company," said Dr Jacques Lemmens, Founder. "Building on our heritage, while preserving our company culture, we are further progressing in innovation, quality and scientific excellence."

"Now is the time to step up as an independent biopharmaceutical company, with our exceptional people, unique technologies and a well-established development pipeline, including our lead ADC, [vic-]trastuzumab duocarmazine. I am very proud of how the Company has grown and evolved. The new name, Byondis, represents the next chapter and embodies our entrepreneurial spirit and ambition to create innovative precision medicines to outsmart cancers and auto-immune diseases."

The Byondis management team has a wealth of scientific, clinical and operational experience, and is well networked within the pharmaceutical industry. Dr Marco Timmers, CEO, and others in the senior team have collaborated for many years as part of Synthon. During this time, they have created a company driven by science and innovation, with unique technologies and significant validation deals. These include the out-licensing of a biosimilar version of the monoclonal antibody trastuzumab (marketed as KANJINTI) in a global partnership agreement with Amgen in 2012.

"As Byondis, we can now showcase our strong business and scientific proposition," added Dr Marco Timmers, CEO. "We have generated a portfolio of preclinical and clinical programs with the potential to deliver completely novel treatments for cancer and auto-immune diseases. We have unique technologies with differentiating potential, state-of-the-art facilities including our own GMP manufacturing, and broad licensing expertise that makes us an attractive partner for out-licensing. This is a really exciting time for Byondis and our team."

Byondis operates from its headquarters in Nijmegen in the Netherlands, with over 350 highly qualified employees working in state-of-the art research and development and GMP manufacturing facilities. The Company has strong links to academic institutions, global medical communities and the international pharma industry.