Monthly Archives

August 2019

WBJ: Viela Bio files to go public with $150M offering

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Gaithersburg-based Viela Bio Inc. has filed to begin trading publicly with a $150 million initial public offering, fast bringing the business full circle after its spinout from MedImmune in early 2018.

The biotech applied to trade on the Nasdaq Global Market under the ticker symbol “VIE” and plans to offer a little more than 37 million shares to the public, including 393,780 shares of unvested restricted stock subject to repurchase.

Viela did not disclose an estimated share price or date for the public offering.

In its maiden registration filing with the Securities and Exchange Commission, Viela disclosed that it incurred no revenue in 2018 but so far has brought in $20 million in licensing revenue this year as of June 30. Viela also reported heavy losses of $190.3 million in 2018, though it signficantly narrowed that figure to $26.4 million in the first half of this year. Such earnings gaps are common for biotechs, as costly drug development and testing and often yearslong regulatory processes make it difficult for them to generate sales.

“We have not commercialized any products and have never generated any revenue from product sales,” the company wrote in its registration statement. “We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The operating losses we incur may fluctuate significantly from quarter-to-quarter and year-to-year.”

To date, Viela has raised a total of $350 million in venture funding and submitted an application to the Food and Drug Administration for approval to start marketing inebilizumab, its lead product candidate for neuromyelitis optica spectrum disorder, rare autoimmune disease that compromises the central nervous system.

Vaccitech Appoints Bill Enright as New Chief Executive Officer

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Vaccitech, a clinical-stage T cell immunotherapy company developing products to treat and prevent cancer and infectious diseases (ID), announced today that it has appointed Bill Enright as its new Chief Executive Officer (CEO). Mr. Enright succeeds Tom Evans, MD who will make a planned transition to the role of Vaccitech’s Chief Scientific Officer.

Bill joins Vaccitech after an accomplished 11 years as CEO at Gaithersburg-based Altimmune Inc, a company developing novel immunotherapies and vaccines. He led Altimmune through a significant period of growth including a Series B financing, the acquisition of Immune Targeting Systems – a UK T-cell vaccine company – and taking the company public on NASDAQ through the acquisition of PharmAthene. Bill’s prior experience includes executive and management roles at GenVec (now Intrexon), Biotech Venture Management and Life Technologies Corporation (now ThermoFisher).

Dr. Andrew Mclean, Vaccitech Board Member, Oxford Science Innovation, said, “we’re incredibly excited to welcome Bill Enright to lead Vaccitech to build a world-leading T-cell induction immunotherapy company.”

“I am delighted to join Vaccitech during this exciting growth phase, ahead of pivotal Phase II data from its lead influenza program and several other key pipeline inflection points. I have been very impressed by the Company’s management team as well as its innovative T cell induction platform. I am looking forward to working with the team to drive the company through the next phase of its development.” said Bill Enright.

Having successfully built Vaccitech to a late clinical stage biopharmaceutical company, in his new role as CSO, Tom Evans MD, will focus more specifically on the science, research and development that underpin Vaccitech’s next generation T-cell induction products.

Click here to read the entire press release.

The BHCR would like to welcome John Newby, the new CEO of VirginiaBio

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the BHCR and BHI are looking forward to working and partnering with you. We also want to thank his predecessor, Jeff Gallagher, for his 7 years of service. Thank you for your work to help build the BioHealth Capital Region and its efforts to become the Top 3 by 2023.
You can follow along with VirginiaBio at:

Hopkins Spinout Graybug Vision Secures $80 million of Additional Funding to Advance its Potentially Transformative Retina and Glaucoma Clinical Programs – Graybug Vision

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Graybug Vision, Inc., a clinical stage pharmaceutical company developing potentially transformative long-acting therapies for ocular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and primary open angle glaucoma (POAG), today announced the securing of an $80 million Series C financing.

Read more …

Emergent BioSolutions’ New President and CEO, Bob Kramer, joins Rich Bendis on BioTalk

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Bob Kramer joins BioTalk to discuss his history with Emergent, his vision for the company, and Emergent’s commitment to the BioHealth Capital Region.

Mr. Kramer serves as president and CEO and as a member of the Board of Directors. He was appointed as CEO and as director effective April 2019 and has served as president since March 2018. Mr. Kramer also served as chief operating officer from March 2018 to March 2019. Prior to this, Mr. Kramer served as executive vice president and chief financial officer from September 2012. Mr. Kramer first joined Emergent in 1999 as its CFO. From 1999 until his retirement in 2010, he held various executive positions with the last being president of Emergent Biodefense Operations Lansing. Mr. Kramer returned to the company in 2011 as the interim head of the biosciences division, and then as interim executive vice president, corporate services division. Prior to joining Emergent in 1999, Mr. Kramer held various financial management positions at Pharmacia Corporation, which subsequently merged with the Upjohn Company in 1995 and eventually became part of Pfizer Inc. Mr. Kramer serves on the board of the U.S. Chamber of Commerce. Mr. Kramer received an M.B.A. from Western Kentucky University and a B.S. in industrial management from Clemson University.

Listen now on iTunes (https://apple.co/2P2fYfO), Google (http://bit.ly/2KKg47H), and TuneIn (http://bit.ly/2LPtYab).

ivWatch Headquarter Operations Opens Doors on Aug. 16 for Ribbon-Cutting

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Medical device manufacturer welcomes visitors during Tech Center event

NEWPORT NEWS, Va., August 13, 2019 – ivWatch, a biosensor technology company focused on improving patient safety and the effectiveness of intravenous (IV) therapy, will participate in the ribbon-cutting celebration at 10:30 a.m. on August 16, 2019 for the opening of Tech Center Research Park’s Building One. The building, in which ivWatch is an anchor tenant, is the first of 10 buildings planned for the park.

The company designed, assembles, and sells a breakthrough medical device which uses sensor technology to monitor what is happening below the skin and into the tissue during drug/fluid delivery and can detect leakage before the human eye. When the ivWatch system detects a leakage, known as an infiltration, it alerts the medical team to inspect the IV site.

“We have entirely transitioned from being a research and development company to an extensive operation serving health care institutions all over the world,” said Gary Warren, president and CEO of ivWatch. “The strategic build-out in a first-class facility like this provides us with all necessary resources to continue to innovate and make waves in our industry.”

While scouting possible headquarter relocation options, the company required a facility that could adapt to support the year-over-year growth projections of the company and a manufacturing space that would allow the company to build in-house production capabilities.

ivWatch operations are housed within a 25,000 sq. ft. footprint including state-of-the-art manufacturing, R&D and office space, and a large medical setting used to conduct pre- and post-market clinical studies.

Click here to read the entire release.

BioHealth Innovation’s Entrepreneur-In-Residence, Dr. Ethel Rubin, joins Rich Bendis on BioTalk to discuss her career, joining BHI, and her work with the NIH

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For the first time, a BioTalk look inside BioHealth Innovation, Inc. (BHI) with Entrepreneur-In-Residence (EIR) Dr. Ethel Rubin

Dr. Ethel Rubin leads a venture team that helps prepare and connect lifescience companies with capital, ensuring strategies that hit valuation inflection points, achieve strategic goals, and prepare for a product launch. She has previously held corporate leadership roles in global clinical strategy and medical affairs at Medtronic, plc, was Chief Scientific Officer of BioFortis, Inc. (acquired by Quintiles-Quest JV) and CSA Medical, Inc., is President of life sciences business development advisory firm Innovative BioStrategies, LLC, and a venture partner at various funds. She has over 25 products in the marketplace garnering 9 figure sales revenue, was instrumental in multiple M&As, partnerships & collaborations, and advises hundreds of CEOs in preparation for seed to series B financing each year. Ethel has held board seats at tech incubators and numerous business and clinical Advisory boards.  Dr. Rubin earned a Ph.D. in Biochemistry and Biophysics from the University of Rochester School of Medicine & Dentistry and a certificate in corporate governance for Board of Directors service from The George Washington University School of Business.

Listen now on iTunes (https://apple.co/318CzZv), Google (http://bit.ly/30WiQfg), and TuneIn (http://bit.ly/2LPtYab).

RoosterBio Raises $15 Million in Initial Series B Round Led by Dynamk Capital

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New Funding, Anticipated to Close at $22 Million, to Fuel Growth of its Regenerative Medicine MSC Manufacturing Platform Worldwide, Scale the Organization, and Accelerate R&D Innovation

Frederick, MDAug. 6, 2019 /PRNewswire-PRWeb/ — RoosterBio Inc, disrupting the market by radically simplifying human mesenchymal stem/stromal cell (hMSC) biomanufacturing, today announced it has raised in excess of $15 million in an initial Series B financing round led by Dynamk Capital. Existing and new investors exhibited strong investment interest, leading to an oversubscribed round. The Series B final round is expected to close with additional investors by the end of August, totaling approximately $22 million raised. The investment will be used to expand and scale the RoosterBio team as its customer base continues to grow internationally, while bolstering research and development for their transformative next generation cell and gene therapy solutions. This funding round represents the powerful partnership between a venture team of industry experts specifically targeting creative life science industrials developing technologies and business models that change the paradigm of biopharmaceutical research, development and biomanufacturing.

“It is critical that we empower scientists to get innovative products to the market more efficiently in order to develop life-saving cures,” said Daniella Kranjac, Founding Partner of Dynamk Capital. “RoosterBio’s pioneering biotechnology platform is driving the revolutionary field of regenerative medicine which has the potential to develop therapies for previously untreatable diseases and conditions. We look forward to helping RoosterBio scale their business and make their technology more broadly available.”

Click here to read the entire Press Release.

Precision For Medicine Launches Biospecimen Solutions Offering With Acquisition Of ProMedDx And GLAS

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ADDITION OF LEADING SUPPLIERS BOLSTERS PRECISION’S BIOMARKER SERVICE OFFERINGS– BRINGING UNPARALLELED SCIENCE, SCALE AND SERVICE TO THE BIOSPECIMEN INDUSTRY

BETHESDA, Md.Aug. 1, 2019 /PRNewswire/ — Precision for Medicine, part of Precision Medicine Group, announced it has acquired leading biospecimen providers ProMedDx and GLAS, significantly expanding its capabilities and expertise in the biospecimen solutions space. With the acquisitions, Precision now offers an unmatched level of scientific understanding, high-quality specimen solutions, and global scale.

The addition of ProMedDx and GLAS establishes an unrivaled biospecimen solutions platform within Precision, which operates one of the largest biorepositories in the world. ProMedDx is known throughout the diagnostics industry for its high-quality biofluid specimens; GLAS is a leader in tissue-based samples. With an expanded sourcing network and client base, along with an enhanced global laboratory infrastructure, Precision can effectively leverage its unique insight as a scientific solutions provider to supply clients with hand-selected, fit-for-purposes specimens for R&D, biomarker development, and companion diagnostics.

Precision for Medicine is the first biomarker-driven clinical development organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Combining two world-class biospecimen organizations, across all specimen types, Precision further enhances its abilities to enable life science innovators with scientifically robust services to accelerate the pace of discovery, development, and commercialization of biomarkers.

Click here to read the entire release.

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