438th Edition, January 12, 2021

While home in Kansas City for the season, BioTalk host Rich Bendis virtually sits down two local business leaders. Innar Health CEO, Chris Mathia, and Flyover Capital Managing Partner, Keith Molzer chat about the opportunities and challenges of BioHealth and Fund-Raising in Middle American.

Listen now via Google http://bit.ly/39ikNss, Apple http://apple.co/3shRRtk, Spotify http://spoti.fi/39ocgUz, and TuneIn http://bit.ly/2XvT0za.

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Wednesday, January 13, 2021

Are you an early stage company with innovative biohealth technology? Have you considered non-dilutive funding to advance your technology? Do you want to know if federal or state non-dilutive funding makes sense for you? Sign up for a free 1:1 advice and feedback session regarding non-dilutive funding applications with BHI’s expert grant strategists. Learn more about funding sources and discuss potential strategies for success. BHI has worked with over 100 companies, helping them secure SBIR/STTR and other federal awards —at twice the national average win rate.

Click here to schedule a time.

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ROCKVILLE, Md., Jan. 6, 2021 /PRNewswire/ — REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it intends to offer and sell, subject to market conditions, $175,000,000 of its common stock in an underwritten public offering. 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 the actual size or terms of the offering. In addition, REGENXBIO intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of common shares sold in connection with the offering.

BofA Securities, Morgan Stanley and Barclays are acting as joint book-running managers of the offering.

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GAITHERSBURG, MD — January 04, 2021 – NexImmune, a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent and durable immune response that mimics natural biology, today announced the hiring of veteran biopharmaceutical industry leader Jerome (Jerry) Zeldis, MD, PhD, as Executive Vice President of Research & Development and the appointment of leading immunotherapy expert Jeffrey Weber, MD, PhD, as Chief Scientific Advisor and Scientific Advisory Board Chair.

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Headquartered in Prague, Czech Republic, Neox is a CRO with over 150 employees who support biotechnology, pharmaceutical, and medical device customers. Neox has provided clinical research support for more than 1,000 studies and has built deep experience across multiple therapeutic areas. The company has operations primarily in central and eastern Europe, with a direct presence in the Czech Republic, Bulgaria, Germany, Hungary, Poland, Romania, Slovakia and Slovenia.  Neox operates in another 11 European countries, including a recently established entity in the United Kingdom.

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Emergent BioSolutions (EBS) – Get Report shares rose Wednesday after the life sciences company and Mount Sinai Health System announced a trial for Emergent’s coronavirus preventative with $34.6 million of support from the Pentagon.

Emergent recently traded at $92.70, up 2.84%, and has surged 71% year to date amid investor enthusiasm for companies involved with Covid treatments.

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Washington, D.C.-based Children’s National Hospital is partnering with the National Institutes of Health and tech firm NVIDIA to launch a challenge in which participants will develop artificial intelligence tools to improve the detection of COVID-19 in the lungs, the hospital announced Jan. 7.

Participants in the COVID-19 Lung CT Lesion Segmentation Grand Challenge will use a multi-institutional, multinational NIH dataset that houses data on patients with a diverse range of age, gender and disease severity to create AI-powered imaging models to help clinicians better identify and treat COVID-19 infection in patients’ lungs.

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CAMBRIDGE, MA and GAITHERSBURG, MD, January 11, 2021 — Myeloid Therapeutics, Inc., a company harnessing and reprogramming yeloid cells to treat cancers, and MaxCyte, Inc., a global cell-based therapies and life sciences company, today announce the signing of a clinical and commercial licensing agreement.

Myeloid Therapeutics will obtain non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. This agreement enables Myeloid to advance its pipeline programs, including for engineered cell therapies targeting solid tumors, T cell lymphoma, and glioblastoma. In return, MaxCyte is entitled to receive undisclosed development and approval milestones, and sales-based payments, along with other licensing fees.

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FREDERICK, Md – January [XX], 2021 – Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced it submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a Phase 1 clinical trial of VLX-1005, a first-in-class small molecule inhibitor of 12-Lipoxygenase in development for the treatment of heparin-induced thrombocytopenia (HIT).

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Gov. Larry Hogan on Monday unveiled a state economic relief package designed to put money into the pockets of low-income Marylanders, help businesses stay afloat and forgive hundreds of millions of taxes on unemployment benefits and other aid.

The $1 billion legislative package, which Hogan is introducing as emergency legislation when the General Assembly session begins Wednesday, is called the Recovery for the Economy, Livelihoods, Industries and Families (RELIEF) Act. Its purpose is to provide “immediate financial relief and tax cuts for Maryland working families, small businesses and those who have lost their jobs” during what Hogan summarized as “one of the worst economic crises in our country’s history.”

Image: Gov. Larry Hogan gives an update on the state’s coronavirus response during a Dec. 1 press conference. JOE ANDRUCYK/MARYLAND GOVPICS/CC 2.0/FLIC.KR/P/2KCWGCT

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COVID-19 vaccine research drove a lot of funding to biotechnology companies in Maryland’s Montgomery County last year, but it didn’t all come from coronavirus research.

Life sciences companies based in, or with a presence in, Maryland’s largest county received nearly $7.7 billion in research and development funding from the federal government, private investors and nonprofit organizations in 2020, according to the Montgomery County Economic Development Corp., a public/private partnership aimed at helping private companies connect with funding, permits and other resources.

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Sykesville, MD, and Fairfax, VA, December 21, 2020 – Noble Life Sciences (NLS), a preclinical contract research organization located in Sykesville, MD, has signed a Collaboration Agreement with George Mason University (Mason) to access the National Center for Biodefense and Infectious Diseases (NCBID) BSL-3 facility located within their Biomedical Research Laboratory at Mason’s Science and Technology Campus in Manassas. The Agreement enables NLS to perform federal and non-federally funded BSL-3 animal model projects to support the development of new antiviral and antibacterial agents against infectious and resistant pathogens.

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ROCKVILLE, Md., Jan. 11, 2021 /PRNewswire/ — Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that long-time employee, Dr. Paul VanVeldhuisen, has been named President of Emmes Public Sector.

Emmes is now organized into two business groups: Emmes Public Sector and Emmes Biopharma. The public sector group includes all the company’s existing federal government clients and contracts, as well as work for foundations, public/private sector partnerships, and not-for-profit organizations.

Image: Paul VanVeldhuisen – PRNewsfoto/Emmes

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The state is providing aid for startups that are struggling to survive this economic downturn.

As part of an economic relief package announced by the State of Maryland in December, TEDCO will be making $5 million available for technology businesses that were hit hardest by the COVID-19 pandemic.

The funding will be available for technology-based businesses that are socially or economically disadvantaged, or based in rural areas, according to TEDCO, which is the quasi-public state agency that supports early-stage tech companies. The funding is expected to be made available in early February.

Image: Les Williams, CRO of Risk Cooperative, speaks at a TEDCO Builder Fund event. (Photo courtesy of TEDCO)

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The Johnson & Johnson Nurses Innovate QuickFire Challenge in Mental Health, together with the American Psychiatric Nurses Association (APNA), invites nurses and nursing students worldwide to submit their nurse-led novel concepts, education programs, protocols, prevention or treatment approaches, screening tools, and consumer product ideas with the power to potentially transform mental health care and well-being for their fellow healthcare professionals or the patients they serve amid the current pandemic environment and beyond.

Areas of interest

• Treatment protocols 
• Health technologies 
• Medical device 
• Preventive approach 
• Consumer product 
• Community health approach 
• Screening tools

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The Johns Hopkins Coronavirus Resource Center, a site launched in the spring of 2020 to offer critical data and perspective during the pandemic, logged its billionth page view today.

Launched March 3, the Coronavirus Resource Center has become a trusted destination for data on the spread and reach of COVID-19. Its continuously updated data trackers and tools help the public, policymakers, and health care professionals worldwide respond to the pandemic. The site includes the latest numbers on cases, testing efforts, and the vaccine rollout as well as expert analysis.

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Richmond, VA, Jan. 07, 2021 (GLOBE NEWSWIRE) — The Center for Innovative Technology (CIT) announced today its Request for Proposals (RFP) for the first solicitation under the newly formed Commonwealth Commercialization Fund (CCF).

The CCF was launched on July 1, 2020 to foster innovative and collaborative commercialization efforts in Virginia, consolidating two legacy programs: the Commonwealth Research Commercialization Fund (CRCF) and the Virginia Research Investment Fund (VRIF). In FY2021, CIT is conducting a single CCF solicitation for young Virginia companies that have strong potential to drive economic growth in Virginia, including through revenue and job creation. Up to $7 million is available to award; a one-to-one match is required.

This competitive round will provide grants up to $100,000 to support companies’ commercialization and market entry goals through product or service development, market research, intellectual property protection, marketing, pilots, and more. High-potential projects are sought in seven strategically important sectors: agricultural and environmental technologies, autonomous systems, clean energy, cybersecurity, data science and analytics, life and health sciences, and space and satellites. All Virginia companies that meet the eligibility criteria are invited to seek funding.

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With more than $650 million in financing in place, vertical construction in excess of 1.1 million square feet of mixed-use space at Port Covington in Baltimore is set to begin at the 235-acre redevelopment site along the city’s waterfront.

This $500 million development phase, known as Chapter 1B, includes 440,000 square feet of office, 586,000 square feet of residential with 537 units, 116,000 square feet of retail, more than 1,000 parking spaces and 10 acres of parks and public space.

Image: Port Covington. Image courtesy of Weller Development Co.

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Ernesto Chanona joined Glen Burnie-based CSSi LifeSciences as its director of business development.

The organization works with companies to advance drugs and medical device technologies from discovery to commercialization.

“The onset of the COVID-19 pandemic has catalyzed business growth throughout the industry, and as such, CSSi LifeSciences is poised to expand in 2021,” Chanona said. “Initially, I’ll be focusing on managing the company’s early-stage clients, housed at incubators all over the world. Growing the pipeline through strategic partnerships with economic development agencies, incubators, universities and startups is also part of the plan.”

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Last year, when GEN prepared an editorial titled Eight Biopharma Trends to Watch in 2020, who could have foreseen COVID-19 and the deaths, illnesses, and economic disruption that the disease would wreak? And who could have foreseen how armies of industry and academic researchers would race to develop hundreds of new and repositioned vaccines and drugs? (GEN tracks more than 300 on its COVID-19 Drug and Vaccine Tracker webpage).

While biopharma was dominated by COVID-19, which prompted a surge of research and business activity, the industry also saw developments that will position it for further growth even after the virus is brought under control.

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Far from the medical labs and test tubes, a fisherman in old rubber boots walks across the docks of West Ocean City to inspect his catch.

He peers in a crate of spiny tails and grasping claws, hundreds of a common yet precious creature, among the oldest species on Earth: horseshoe crabs.

The scene on the docks is a glimpse into a strange and guarded Maryland fishery, one supporting a multimillion-dollar industry as surprising as the catch itself — a seemingly alien creature with 10 eyes, 12 legs and magical, milky blue blood.

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The Trade and Cooperation Agreement and other agreements below are provided for information only. No rights may be derived from them until the date of application. The numbering of the articles is provisional.

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US healthcare venture fundraising soared in 2020, totaling $17B, a 57% increase over 2019’s record.

Image: https://www.svb.com

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