On November 15, 2018 Atlanta, GA and New York) Lori Chmura, CEO of Dune Medical Devices, reported that maker of the successful MarginProbe device is scheduled to present at the Canaccord Genuity Medical Technologies and Diagnostics Forum on Thursday, November 15th at 2:30 p.m. EST at the Westin Grand Central in New York, NY (Press release, Dune Medical Devices, NOV 15, 2018, View Source [SID1234531341]).

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The presentation will be available as a webcast at dunemedical.com/investors.

Dune Medical Devices is a commercial-stage company revolutionizing tissue characterization technology in breast cancer surgery, diagnosis and targeted treatment with its proprietary Radio-Frequency Spectroscopy Technology (RFST). Dune’s first commercial product, MarginProbe, in routine commercial use in 70 hospitals and in over 16,000 surgeries in the US and Israel, has been proven to identify positive margins during breast conservation surgery, enabling surgeons to immediately remove additional microscopic residual cancer, thereby reducing the need for repeat surgeries. The second generation of the RFST, in development, serves as a platform to enhance diagnostic accuracy by providing pathologists with tissue characterization data alongside biopsy samples to increase interpretation accuracy and eliminate unnecessary procedures and costs

Dune is entering a phase of commercial growth and expansion of its RFST platform to establish RFST data as a unique tissue biomarker that provides information complementary to molecular (e.g., genomic) biomarkers for optimal personalized treatment selection and adoption of new therapies

On November 15, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully completed a U.S. Food and Drug Administration (FDA) required formal report on the safety studies conducted by Bavarian Nordic using a pig model that were undertaken before the first clinical trial in humans using cellulose-based capsules that contain live genetically altered cells which activate the anticancer prodrug ifosfamide (Press release, PharmaCyte Biotech, NOV 15, 2018, View Source [SID1234531357]). The voluminous information contained in the formal report is another complicated Investigational New Drug Application (IND) component requested by the FDA to be included in the IND before the start of the clinical trial for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).

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A formal study report, including all the data from the previously performed porcine animal studies, has been completed and independently reviewed and verified. The original data was published in part in the journal Pancreatology, but the confines of that scientific publication did not allow for the complete volume of data to be included in the journal article, necessitating several components of the studies to be woven together in a formal study report according to FDA guidelines. The original data was compiled and independently reviewed by Facet Life Sciences with the support of original members of the team that performed the porcine experiments, including Prof. Matthias Löhr who was the Principal Investigator for the first two pancreatic cancer trials with what has evolved into PharmaCyte’s current treatment for pancreatic cancer. The final study report has now been signed off on by two members of the original team, Prof. Udo Losert and Prof. Walter H. Günzburg, and will be submitted to the FDA as part of the IND dossier required for approval for the commencement of PharmaCyte’s planned clinical trial in LAPC.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "These large animal studies, which had to be retrieved from locations in several countries in Europe, demonstrate the safety of delivering capsules to the blood vessels (vasculature) leading to the pancreas in pigs and are supported by the initial clinical trial data generated to date, primarily from trials in Germany. The formal study report allows us to submit the complete set of data in the appropriate fashion to the FDA as part of our IND submission for our upcoming LAPC trial in the U.S."

On November 14, 2018 Agilent Technologies Inc. (NYSE: A) reported it has completed the acquisition of ACEA Biosciences Inc. (ACEA), a developer of cutting-edge cell analysis tools, for $250 million in cash (Press release, Agilent, NOV 14, 2018, View Source [SID1234531314]). This acquisition brings together two pioneers in cellular function and metabolism measurements focused on real-time, live cell analyses.

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ACEA has developed two ground-breaking platforms that are complementary to Agilent’s current portfolio. The ACEA xCELLigence RTCA technology is a unique impedance platform for label-free, real-time cellular function measurements used in immuno-oncology, pre-clinical drug discovery and development, as well as in basic academic research. This technology is complemented by the introduction in recent years of the NovoCyte and NovoCyte Quanteon portfolio of high performance bench top flow cytometry systems.

ACEA also markets a clinical configuration of the NovoCyte platform, currently commercialized in China. This provides a unique opportunity in combination with Agilent’s Reagent Partnership business within Agilent’s Diagnostics and Genomics Group which provides reagents for flow cytometry.

"The Agilent and ACEA teams are united by a common goal to provide the most innovative high-performance solutions for cell analysis," said Todd Christian, Vice President & General Manager of Agilent’s Cell Analysis Division. "We are excited for the opportunities we have as a newly combined team to provide the most advanced tools for scientists performing cell analysis workflows."

ACEA is Agilent’s second acquisition this year in the cell analysis space. In January, Agilent acquired Luxcel Biosciences, a developer of real-time fluorescence plate-reader based in vitro cell assay kits. Cell analysis is a key area of strategic focus for Agilent.

ACEA was founded in 2002 and has its headquarters in San Diego and a large manufacturing and R&D footprint in Hangzhou, China. More than 2,500 ACEA instruments have been placed globally and have been used in more than 1,800 peer-reviewed publications.

On November 14, 2018 Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage biopharmaceutical company developing innovative therapies to improve outcomes in cancers that are difficult to treat, reported that Douglas J. Swirsky, who has served as Rexahn’s president and chief financial officer since January 2018, has been named the company’s president and chief executive officer and appointed to the company’s board of directors effective immediately (Press release, Rexahn, NOV 14, 2018, View Source [SID1234531477]). Peter D. Suzdak, Ph.D., chief executive officer, has departed the company and resigned as a member of its board of directors.

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"On behalf of the board and everyone at Rexahn, I want to thank Peter Suzdak for his contributions to the company over the past six years," said Peter Brandt, chairman of the board of directors. "The board is confident that Doug has the experience and creativity to deliver on the promise of Rexahn’s innovative pipeline and lead the company forward through substantial value-creating milestones."

"I am excited about the future of Rexahn and believe significant opportunities exist to transform Rexahn into an industry-leading, cancer-focused company. I look forward to working with the board, the executive team and all stakeholders to achieve this goal," said Mr. Swirsky.

Prior to joining Rexahn, Mr. Swirsky was CEO and a director of GenVec, Inc., a publicly traded biotechnology company, a position he held from 2013 through the sale of the company in 2017. He also served as GenVec’s CFO from 2006 until he assumed the role of CEO in 2013. Prior to joining GenVec, Mr. Swirsky was a managing director and the head of life sciences investment banking at Stifel Nicolaus from 2005 to 2006 and held investment banking positions at Legg Mason from 2002 until Stifel Financial’s acquisition of the Legg Mason Capital Markets business in 2005. He has also previously held investment banking positions at UBS, PaineWebber and Morgan Stanley. Mr. Swirsky currently serves on the board of directors of Fibrocell Science, Inc., Cellectar Biosciences, Inc. and Pernix Therapeutics Holdings, Inc. He is a certified public accountant and a CFA charter holder. He received his B.S. in Business Administration from Boston University and his M.B.A. from the Kellogg School of Management at Northwestern University.

Mr. Swirsky will also continue to serve as the company’s principal financial officer.

On November 14, 2018 On November 9, 2018, Adhera Therapeutics, Inc. (the "Company") entered into Subscription Agreements (the "Purchase Agreements") with certain accredited investors and conducted a closing pursuant to which the Company sold 73 shares of the Company’s Series F convertible preferred stock, par value of $0.01 per share (the "Preferred Stock"), at a purchase price of $5,000 per share of Preferred Stock (Filing, 8-K, Marina Biotech, NOV 14, 2018, View Source [SID1234531299]). Each share of Preferred Stock is initially convertible into shares of the Company’s common stock, par value $0.006 per share (the "Common Stock"), at a conversion price of $0.50 per share of Common Stock. In addition, each investor received a 5-year warrant (the "Warrants", and collectively with the Preferred Stock, the "Securities", and the offering of the Securities, the "Private Placement") to purchase 0.75 shares of Common Stock for each share of Common Stock issuable upon the conversion of the Preferred Stock purchased by such investor at an exercise price equal to $0.55 per share of Common Stock, subject to adjustment thereunder.

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The Company received total net proceeds of approximately $0.31 million from the issuance of the Securities described above, after deducting placement agent fees and estimated expenses payable by the Company associated with such closing. The Company intends to use the proceeds of the Private Placement to fund its commercial operations relating to the sale and promotion of the Company’s Prestalia product and the potential acquisition of additional commercial assets. Prestalia is a single-pill fixed dose combination of perindopril arginine, an angiotensin-converting-enzyme inhibitor, and amlodipine besylate, a calcium channel blocker, which has been approved by the U.S. Food and Drug Administration and is actively marketed in the U.S.

The Securities were being offered and sold in a private placement pursuant to exemptions from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), afforded by Section 4(a)(2) and Rule 506(b) of Regulation D promulgated thereunder. To the extent that any shares of Common Stock are issued in connection with the conversion of the Preferred Stock or the exercise of the Warrants, the Common Stock may not be offered, transferred or sold in the United States absent registration or the availability of an applicable exemption from the registration requirements of the Securities Act.

The rights, preferences and privileges of the Preferred Stock are set forth in a Certificate of Designation of Preferences, Rights and Limitations of the Series F Convertible Preferred Stock of Adhera Therapeutics, Inc. (the "Certificate of Designation") that was filed with the Secretary of State of the State of Delaware on July 11, 2018. The Certificate of Designation was filed as Exhibit 3.1 to the Current Report on Form 8-K that the Company filed with the Securities and Exchange Commission on July 16, 2018 (the "July 8-K"), and the rights, preferences and privileges of the Preferred Stock were summarized in the July 8-K. The form of Warrant that was issued at the Closing was filed as Exhibit 4.1 to the July 8-K, and the terms and provisions thereof were summarized in the July 8-K.

The foregoing summaries of the material terms and provisions of the Certificate of Designation and the form of Warrant are not complete and are qualified in their entirety by reference to the full text thereof, copies of each of which are filed herewith as Exhibits 3.1 and 4.1, respectively, and incorporated by reference herein.