Reverse BioTalk – Jeff Galvin, CEO of American Gene Technologies Interviews Rich Bendis, CEO and President of BioHealth Innovation, Inc.

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Jeff Galvin, CEO of American Gene Technologies and Rich Bendis, CEO and President of BioHealth Innovation, Inc. have a fireside chat about the rapid evolution of the BioHealth Capital Region.

You can also listen to the audio only version via Apple https://apple.co/37wc6Kk, Google https://bit.ly/2XbLe0v, Spotify https://spoti.fi/3yCWhxE, and TuneIn https://bit.ly/3AqYkoR.

Click here to view the video interview between Jeff and Rich.

On the heels of Silicon Valley’s branding as one of the world’s largest tech hubs, the BioHealth Capital Region aims to brand the DMV region as one of the most prominent BioHealth clusters in the Mid-Atlantic. BioHealth Innovation, Inc. was founded 11 years ago in an effort to drive ideas from labs into markets through innovation-driven economic development organizations and initiatives.

Galvin and Bendis discuss the abundance of opportunities for growth within the region as it is home to a wide variety of research institutions, top scientists, and annual grants. Additionally, they discuss how BioHealth Innovation, Inc. cultivates success for companies within the competitive region.

Click here to view the video interview between Jeff and Rich.

Mason’s Michael Buschmann and team at start-up AexeRNA Therapeutics Inc. pursue patents for improved COVID-19 vaccines

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George Mason University bioengineering professor Michael Buschmann and a team of scientific collaborators have devised improved lipid nanoparticle  technologies to deliver mRNA that could make mRNA vaccines such as the COVID-19 vaccines less costly, with fewer side-effects and more available worldwide.

Vaccines with mRNA use lipid nanoparticles (LNPs) to protect the mRNA and facilitate the immune system’s response to protect people against infection by viruses. This technology has flattened the COVID-19 curve in Western industrialized nations, but the vaccine will need to evolve to reduce side effects and permit worldwide vaccination to eradicate the disease.

Working with George Mason University’s Office of Tech Transfer (OTT) to form the start-up AexeRNA Therapeutics Inc., Buschmann and his team have licensed the commercial rights of four patent applications to the company. The patents address two major LNP technology issues related to novel lipid molecules and novel methods of LNP manufacturing.

“Our solutions seek to make the vaccine more efficient, less costly, and decrease its adverse effects,” said Buschmann, the chair of the Bioengineering Department within Mason’s College of Engineering and Computing.

By modifying the structure and composition of the LNPs, the researchers were able to make the vaccine more efficient, less toxic and easier to make, handle and distribute.

Click here to read more via GMU.EDU.

Paul Rennie OBE and Professor Jason Snape Join Rich Bendis on BioTalk

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Paul Rennie OBE, Counsellor for Global Issues in the Global Economy Group at the British Embassy, Washington DC, and Professor Jason Snape, Head of Environmental Protection within AstraZeneca’s Global Sustainability Team, join Rich Bendis to Discuss Life Sciences, Climate Change, COP26 – UN Climate Change Conference, and The Race to Zero Campaign.

Listen now via Apple https://apple.co/3ls3EEp, Google https://bit.ly/3liTlSU, Spotify https://spoti.fi/3ylxair, and TuneIn https://bit.ly/3rS9Giz.

Paul Rennie, OBE, is the Counsellor for Global Issues in the Global Economy Group at the British Embassy, Washington DC, leading the UK’s climate and energy, economic and trade, and science and technology networks across the United States. Prior to that, he led the Foreign Office’s strategic transformation programme, focused on delivering a 21st century Diplomatic Service. Paul was born in Edinburgh and educated at George Heriot’s School, before going on to graduate with an MA in Economics and Politics (Edinburgh University) and an MSc in Economics (York University). He joined the Foreign and Commonwealth Office in 2001 as the first of a new group of Diplomatic Service Economists. He has served at the United Nations (New York), Brazil, India and Malaysia, as well as working on secondment to the Cabinet Office and the Department for International Development. In addition to his economic work, Paul speaks five languages (English, French, Dutch, Portuguese and Hindi).

Professor Jason Snape is the Global Head of Environment within AstraZeneca’s Global Sustainability Team. Accountable for delivering AstraZeneca’s global ambitions to drive natural resource reduction (ambition zero carbon, water and waste reduction) and ensure the environmental safety of pharmaceuticals throughout their lifecycle (product environmental stewardship and pharmaceuticals in the environment). Member of the AstraZeneca UK Leadership Team.  Chair of the European Federation of Pharmaceutical Industry Associations (EFPIA), Medicines for Europe, and AESGP working group on the environmental risk assessment of human medicinal products. Recognized scientific leader and opinion former with >6000 citations from approximately 50 publications. Honorary Clinical Professor at the University of Warwick and a Professor of Environmental Engineering at the University of Newcastle.  Member of the University of York’s Environmental Sustainability Advisory Board.  Co-chair the Society of Environmental Toxicology and Chemistry (SETAC) Pharmaceutical Advisory Group.

Click here for the transcript.

Emergent BioSolutions to Resume Manufacturing Covid-19 Vaccine at Bayview Facility

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GAITHERSBURG, Md., July 29, 2021 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) is allowing Emergent’s Bayview manufacturing facility to resume production of Johnson & Johnson’s (J&J) Covid-19 vaccine bulk drug substance. This resumption of manufacturing follows extensive reviews by FDA, weeks of diligent work, and close coordination with J&J and FDA to execute on Emergent’s quality enhancement plan.

“We are proud to be resuming production of bulk Covid-19 vaccine batches following additional reviews and collaboration with FDA and our manufacturing partners,” said Emergent chief executive officer, Robert Kramer. “We are in the unique business of producing life-saving medications for catastrophes that we hope never occur like anthrax attacks, opioid overdoses, and Covid-19.”

Since production was paused at Bayview, Emergent has worked closely with FDA and J&J to address quality concerns including developing and executing an action plan and committing extensive resources to bring operations up to FDA’s exacting standards. Emergent expects to continue to work with FDA throughout the manufacturing process to help ensure the strength of the J&J Covid-19 vaccine supply chain.

“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” said Kramer. “We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this global pandemic to an end. We’d like to thank our government partners as well as Johnson & Johnson for their support.”

About Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through Emergent’s specialty products and contract development and manufacturing services, Emergent is dedicated to providing solutions that address public health threats. Through social responsibility, Emergent aims to build healthier and safer communities. Emergent aspires to deliver peace of mind to its patients and customers so they can focus on what’s most important in their lives. In working together, Emergent envisions protecting or enhancing 1 billion lives by 2030. For additional information, visit Emergent’s website and follow Emergent on LinkedInTwitter and Instagram.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our ability to meet the FDA’s exacting standards, ensuring the strength of J&J’s supply chain, receipt of EUA from the FDA for the Bayview facility and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates,” and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs, and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. The reader should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events, or circumstances.

There are a number of important factors that could cause Emergent’s actual results to differ materially from those indicated by such forward-looking statements, including our ability to maintain production at FDA standards and receive EUA for our Bayview facility. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. The reader should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the Securities and Exchange Commission, when evaluating our forward-looking statements.

Contacts:

Media:
Matt Hartwig
Director, Media Relations
(240) 760-0551
mediarelations@ebsi.com

Investors:
Robert G. Burrows
Vice President, Investor Relations
(240) 631-3280
burrowsr@ebsi.com

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MaxCyte Announces Pricing of Upsized Offering and Approval to List on the Nasdaq Global Select Market

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GAITHERSBURG, Md.July 29, 2021 /PRNewswire/ — MaxCyte, Inc., (LSE: MXCT, MXCN), a leading provider of cell-engineering platform technologies, today announced the pricing of its upsized offering of 13,500,000 shares of common stock at an initial offering price of US$13.00 per share (the “Offering“).

Highlights

  • Anticipated gross proceeds of approximately US$175,500,000 (or US$201,825,000 if the underwriters exercise their option to purchase additional shares of common stock in full), before deducting underwriting discounts and commissions and estimated offering expenses payable by MaxCyte
  • MaxCyte intends to use the net proceeds from the Offering for research and development initiatives, to expand its manufacturing capabilities and invest in manufacturing automation, to expand its sales and marketing, business development and field application scientist teams, and for working capital and general corporate purposes
  • Shares of common stock are expected to commence trading on the Nasdaq Global Select Market (“Nasdaq“) on July 30, 2021 under the symbol “MXCT”

MaxCyte has granted the underwriters a 30-day option to purchase up to 2,025,000 additional shares of common stock at the initial offering price per share of common stock less underwriting discounts and commissions.

The closing of the Offering is expected to occur on August 3, 2021, subject to customary closing conditions.

MaxCyte’s common stock will continue to be admitted to trading on the AIM market of the London Stock Exchange (the “AIM“) under the symbols “MXCT” and “MXCN.” Application is being made for the shares of common stock to be issued at the closing of the Offering to be admitted to trading on AIM under the symbol “MXCT” and it is expected that admission will become effective and dealings in the shares of common stock will commence at 8:00 a.m. (BST) on August 4, 2021.

Cowen, Stifel and William Blair are acting as joint book-running managers for the Offering and as representatives of the underwriters for the Offering. BTIG and Stephens Inc. are also acting as co-managers of the Offering.

A registration statement, including a prospectus, relating to these securities has been filed by MaxCyte and was declared effective by the Securities and Exchange Commission on July 29, 2021. Copies of the registration statement can be accessed through the SEC’s website at www.sec.gov. The Offering is being made only by means of a prospectus. When available, copies of the final prospectus relating to and describing the terms of the Offering may be obtained from the offices of Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, USA, Attn: Prospectus Department, by telephone at +1 (833) 297-2926 or by email at PostSaleManualRequests@broadridge.com; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, USA, by telephone at +1 (415) 364-2720 or by email at syndprospectus@stifel.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, USA, by telephone at +1 (800) 621-0687 or by email at prospectus@williamblair.com.

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

Related party transaction

Casdin Partners Master Fund, L.P. (“Casdin“) has indicated an interest in purchasing 1,800,000 shares of common stock at the same price and on the same terms as all other participants in the Offering. Immediately following issuance, Casdin would hold a total of 13,971,334 shares of common stock representing, in aggregate, approximately 14% of MaxCyte’s outstanding shares following closing of the Offering.

The participation by Casdin in the Offering constitutes a related party transaction for the purposes of the AIM Rules for Companies. The independent directors for the purposes of the Offering (being the all of the members of MaxCyte’s board of directors), having consulted with MaxCyte’s nominated adviser, Panmure Gordon, consider that the terms of the related party transaction are fair and reasonable insofar as MaxCyte’s shareholders are concerned.

Amendments to the Bylaws

In connection with the Offering, MaxCyte has adopted amended and restated Bylaws (the “Bylaws“), which will take effect immediately before the closing of the Offering. As before, certain rights have been incorporated into the Bylaws which the Company believes stockholders would expect to see in a company whose shares are admitted to trading  on a U.S. listed exchange. A copy of the Bylaws will be publicly filed and made available to both Nasdaq and AIM shareholders upon closing of the Offering.

About MaxCyte

MaxCyte is a leading provider of cell-engineering platform technologies to advance innovative cell-based research, development and potential commercialization of next-generation cell therapies. The company’s existing customer base ranges from large biopharmaceutical companies — including 20 of the top 25 pharmaceutical companies based on 2020 global revenue — to hundreds of biotechnology companies and academic translational centers. MaxCyte has granted 13 strategic platform licenses to commercial cell therapy developers that allow for more than 75 clinical programs. Founded in 1998, MaxCyte is headquartered in Gaithersburg, Maryland, US.

Forward-Looking Statements

Certain statements made in this press release are forward-looking statements including with respect to the creation of a trading market for shares of the Company’s common stock in the United States, the commencement of trading of the shares of common stock on Nasdaq, the completion and timing of the closing of the Offering and the expected amount of gross proceeds and use of anticipated net proceeds from the Offering. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements, including if the shares of common stock are not admitted to trading on AIM or if there are adverse market or economic conditions. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this press release. The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

USP, NIST & NIIMBL Researchers Collaborate to Improve Measurement of Viral Vectors Used in Cutting-Edge Gene Therapy

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New Collaboration Aims to Improve Measurement of Viral Vectors Used in Cutting-Edge Gene Therapies

A large interlaboratory study of adeno-associated virus (AAV), an important tool in gene therapy, will be led by USP and NIST in collaboration with NIIMBL.

Rockville, MD, July 27, 2021 —The United States Pharmacopeia (USP), the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) and The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) have announced a research collaboration to assess analytical methods and develop standards for adeno-associated virus (AAV), an important mechanism for delivering gene therapies.

AAVs are particularly useful for gene therapies because they are not known to cause human disease and cannot replicate on their own. AAV-based therapies are currently used to treat a type of inherited retinal dystrophy that causes blindness and spinal muscular atrophy in children, and treatments for many more diseases are currently being developed. However, to use AAVs most effectively, scientists need to accurately measure attributes related to their quality. These attributes include the purity of the AAV product and the relative number of virus particles that contain the full genetic payload.

At a workshop hosted by NIIMBL in 2019, academic and industry scientists, product developers, instrument manufacturers and other stakeholders identified needs for improved consistency of measurement methods and physical standards for AAV-based products as top priorities.

“AAV is important because these are critical components to manufacture a variety of gene and cell therapy products,” explained Kelvin Lee, NIIMBL institute director. “By addressing the quality attributes assessment of viral vectors, the field of gene therapies as a whole will benefit from access to high quality components to enable the development of a variety of products.”

As part of this collaboration, USP and NIST will conduct an interlaboratory study in which multiple laboratories will measure these critical quality attributes and their results will be compared and analyzed. This will contribute to the standardization of measurement methods and the development of physical reference materials that will improve measurement consistency across the industry. The study will take  two to three years to complete.

“There is great level of synergy between the organizations engaged in this collaboration,” said Fouad Atouf, USP vice president of global biologics. “NIST’s long-standing experience with measurement sciences and USP’s established role in the application of measurement to the development of methods and associated reference standards is a great combination to advance the field of testing of biopharmaceuticals. NIIMBL provides the appropriate collaborative platform and access to the right stakeholders.”

“This work will help build trust in the quality of AAV,” said NIST research scientist and chemical engineer Wyatt N. Vreeland, who will be leading the NIST component of the collaboration. “And it will support the development of promising new gene therapies that will greatly improve peoples’ lives.”

About USP

The United States Pharmacopeia (USP) is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements and food ingredients. USP’s standards are used in the U.S. and other countries to ensure the quality of thousands of products including cardiovascular, oncology, endocrine and antibiotic drugs. Through its standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and food for billions of people worldwide.

About NIST

The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) promotes U.S. innovation and industrial competitiveness by advancing measurement science, standards and technology in ways that enhance economic security and improve our quality of life. NIST supports the biomanufacturing sector by improving measurement science for the accurate and reproducible characterization of a wide range of processes and products and through the development of reference materials and interlaboratory comparisons.

About NIIMBL

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce with significant additional support from its members.

Media Contacts

USP

Anne Bell

ADB@USP.org

NIST

Richard Press

richard.press@nist.gov

NIIMBL

Maria Chacon

mchacon@udel.edu

Tonix Pharmaceuticals Announces Agreement to Acquire Infectious Disease R&D Facility Frederick, MD to Accelerate Development of Vaccines and Antiviral Drugs

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R&D Facility in Frederick, MD is Expected to Provide Internal Capacity to Discover and Develop Vaccines and Antiviral Drugs Against COVID-19, its Variants and Other Infectious Diseases

Facility, Currently Owned and Operated by Tonix Partner Southern Research, has Housed Research Relating to Tonix’s COVID-19 Vaccine Candidate, TNX-1800 and Smallpox and Monkeypox Vaccine Candidate, TNX-801

CHATHAM, N.J., July 27, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the signing of a Purchase and Sale Agreement to acquire an approximately 48,000 square foot research and development (R&D) facility in Frederick, MD to support Tonix’s expanding infectious disease pipeline, including TNX-1800, a live replicating viral vaccine designed to protect against COVID-19, TNX-801, a live vaccine designed to protect against smallpox and monkeypox, and TNX-3500, a small molecule antiviral to inhibit replication of SARS-CoV-2.

Tonix agreed to purchase the R&D facility from Southern Research, a research collaboration partner for TNX-1800 and TNX-801 development. The facility currently operates at biosafety level 2 (BSL-2) containment. Pending transfer and approval of relevant permits, Tonix expects the transaction to close and the facility to be operational in the fourth quarter of 2021. Southern Research plans to consolidate its research activities at its Birmingham, AL campus. Tonix and Southern Research plan to continue those aspects of their collaboration on the development of vaccines and antivirals that are ongoing at the Birmingham, AL campus.

“The Fredrick facility will be a major expansion of our R&D capabilities,” stated Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “We believe this facility will ensure adequate resources and capacity to support and grow our pipeline of vaccines and antiviral therapeutics. In addition, we view control of in-house facilities as a strategic capability to ensure the speed and efficiency with which we can develop vaccines and antiviral products in the future against known, emerging or novel pathogens.”

Dr. Lederman continued, “While COVID-19 has the appearance of being controlled in certain geographic centers, reports of increasing infections in both unvaccinated and vaccinated individuals, primarily related to new variants, have led to new mask mandates and restrictions in parts of the U.S. as well as new lockdowns and other restrictions in Europe and elsewhere. These concerning trends point to an urgent need for more robust vaccine technology and better overall preparedness. The COVID-19 pandemic revealed weaknesses in the U.S. domestic capability to conduct infectious disease R&D and produce vaccines and therapeutics, particularly in the setting of an interrupted global supply chain. We believe our planned capabilities at the Frederick facility will provide greatly needed domestic resources. The facility is ideally located in Maryland’s ’biotech corridor’, which is rich in highly skilled talent, and is also close to the center of the U.S. biodefense research community.”

Josh Carpenter, PhD, Chief Executive Officer of Southern Research stated, “We are delighted that Tonix will be acquiring the Frederick research campus. This is another chapter in a robust partnership that will be made even stronger. We have enjoyed partnering with Tonix on TNX-1800 and TNX-801 vaccine projects and look forward to continued collaboration on these projects, as well as TNX-3500 with work performed at our Birmingham campus.”

Tonix’s Fredrick R&D facility will complement its Advanced Development Center (ADC) being constructed in New Bedford, MA and the Commercial Manufacturing Center (CMC) that Tonix is planning in Hamilton, MT. The ADC will house laboratories dedicated to process analytical development and pilot manufacturing of its vaccine candidates. The CMC is expected to support commercial scale manufacturing of vaccine products.

Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia. Tonix’s immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix’s lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. TNX-35003 (sangivamycin) is a small molecule antiviral drug in the pre-IND stage of development.

1TNX-102 SL is an investigational new drug and has not been approved for any indication.
2TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.
3TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

About Southern Research

Founded in 1941, Southern Research (SR) is an independent, 501(c)(3) nonprofit affiliated with the University of Alabama at Birmingham. SR is an applied scientific research organization with more than 400 scientists and engineers working across four divisions: CRO services, Drug Discovery, Energy Storage, and Engineering. SR has supported the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries. SR works on behalf of the National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Energy, NASA and other major aerospace firms, utility companies, and other external academic, industry and government agencies. SR pursues entrepreneurial and collaborative initiatives to develop and maintain a pipeline of intellectual property and innovative technologies that positively impact real-world problems. SR has numerous ongoing drug discovery programs, which encompass drug discovery programs to combat various forms of cancer, Alzheimer’s, schizophrenia, opioid use disorder, human immunodeficiency virus, disease, Parkinson’s, tuberculosis, influenza, and others. SR’s strong history, which includes nearly 80 years of successful collaborations to solve complex problems, has led to the discovery of seven FDA-approved cancer drugs—a number rivaling any other U.S. research institute. Furthermore, experts at SR are well-equipped to assist with the challenging landscapes of drug design and development technologies and market viability. SR is headquartered in Birmingham, Alabama.

Further information about SR can be found at https://southernresearch.org

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development of R&D facilities, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
Westwicke/ICR
peter.vozzo@westwicke.com
(443) 213-0505

BXP Life Sciences Expands with Montgomery County, Maryland Acquisition

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BOSTON PROPERTIES EXPANDS ITS LIFE SCIENCES GROWTH OPPORTUNITY; AGREES TO ACQUIRE 435,000 SQUARE-FOOT CAMPUS FOR LAB REDEVELOPMENT IN THE SHADY GROVE LIFE SCIENCES CLUSTER IN MONTGOMERY COUNTY, MARYLAND

BOSTON – July 27, 2021 – Boston Properties, Inc. (NYSE: BXP), the largest publicly traded developer, owner, and manager of Class A office properties in the United States, announced today that it has agreed to purchase the Shady Grove Bio+Tech Campus in Rockville, Maryland. The property includes seven existing buildings comprising approximately 435,000 square feet across 31 acres in the Shady Grove life sciences cluster, a highly desirable location for leading and emerging companies in the biotechnology sector.

The Company plans to convert the office buildings on the campus to lab to meet current and growing demand in the region from biotechnology companies for new, Class A lab space. The Company expects to begin reconstruction of three of the buildings, which are currently vacant, promptly after closing, which is currently expected to occur in Q3 2021. The Company intends to redevelop or convert the remaining four buildings to lab or life sciences-related uses as each becomes vacant. The gross purchase price for the property is $116.5 million. BXP will own 100% of the campus.

This acquisition builds on BXP’s growing Life Sciences portfolio, which consists of more than 3 million square feet of in-service properties and approximately 1 million square feet of lab development and redevelopment projects that are currently under construction and expected to deliver in the next 36 months. The BXP portfolio also includes approximately 5 million square feet of development opportunities focused on the specific needs of the life sciences sector primarily in Boston, Cambridge, and Waltham/Lexington, Massachusetts, San Francisco, California and now Montgomery County, Maryland.

The Shady Grove Bio+Tech Campus is located in the City of Rockville and is surrounded by the premier cluster for life sciences in Maryland. The campus is situated within a half mile of I-270 with convenient access to MD-355 and other regional arteries. The Montgomery County, Maryland submarket is consistently ranked as one of the top five life sciences clusters in the U.S. and is the epicenter of national public health research and regulatory leadership, hosting the headquarters of the National Institutes of Health (NIH), US Pharmacopeia, the National Institute of Standards and Technology (NIST), the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Food and Drug Administration (FDA). The area is also supported by several active biotech incubators, both public and private, that accelerate companies and their research. The region is home to more than 400 emerging and established biotechnology and life sciences companies. Top universities in the region, including Johns Hopkins University and the University of Maryland System, produce STEM graduates at a rate that is on par with the regions surrounding other top biotech innovation clusters in the U.S.

“Suburban Maryland benefits from existing dynamics that provide a strong foundation for growth in the life science industry. Growing demand, combined with limited supply, make Montgomery County, Maryland, and this cluster in particular, an attractive opportunity for BXP to expand its life sciences presence,” said Pete Otteni, SVP, Co-Head of the Washington, DC Region, BXP. “We look forward to using our life sciences expertise and real estate skills to transform the property into a leading life sciences campus in the region.”

“We are thrilled to expand our BXP Life Sciences portfolio with the acquisition of Shady Grove Bio+Tech Campus, furthering our ability to create great space and place for scientific discovery,” said David Provost, Co-Head of BXP Life Sciences.

The property’s seller, Lantian Development, was represented by Tommy Cleaver, Dan Grimes, and Stuart Kenny of CBRE.

This press release contains forward-looking statements within the meaning of the Federal securities laws. You can identify these statements by our use of the words “will,” “expects,” “intends” and similar expressions that do not relate to historical matters. You should exercise caution in interpreting and relying on forward-looking statements because they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond Boston Properties’ control and could materially affect actual results, performance or achievements. These factors include, without limitation, Boston Properties’ ability to satisfy the closing conditions and/or complete the transaction on the terms currently contemplated or at all, its ability to complete the conversion and redevelopment projects referenced above on time, within budget or at all, and other risks and uncertainties detailed from time to time in Boston Properties’ filings with the SEC. Boston Properties does not undertake a duty to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

About Boston Properties
Boston Properties (NYSE: BXP) is the largest publicly traded developer, owner, and manager of Class A office properties in the United States, concentrated in five markets – Boston, Los Angeles, New York, San Francisco and Washington, DC. The Company is a fully integrated real estate company, organized as a real estate investment trust (REIT), that develops, manages, operates, acquires and owns a diverse portfolio of primarily Class A office space. Including properties owned by joint ventures, the Company’s portfolio totals 51.6 million square feet and 196 properties, including nine properties under construction/redevelopment. For more information about Boston Properties, please visit our website at www.bxp.com or follow us on LinkedIn or Instagram.

At the Company
Sara Buda
Vice President, Investor Relations
sbuda@bxp.com
617.236.3429

Laura Sesody
Vice President, Corporate Marketing & Communication
lsesody@bxp.com
617.236.3305

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Charles River Laboratories Completes Acquisition of Rockville’s Vigene Biosciences

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June 29, 2021 07:00 AM Eastern Daylight Time

WILMINGTON, Mass.–(BUSINESS WIRE)–Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it has completed the previously announced acquisition of Vigene Biosciences, Inc. for $292.5 million in cash, subject to customary closing adjustments. In addition to the initial purchase price, the transaction includes additional payments of up to $57.5 million, contingent on future performance.

Based in Rockville, Maryland, Vigene Biosciences is a premier, gene therapy contract development and manufacturing organization (CDMO), providing viral vector-based gene delivery solutions. Vigene’s primary area of expertise is CGMP viral vector manufacturing, which is used for gene therapies and gene-modified cell therapies. It also offers high-quality, research grade and CGMP plasmid DNA. The acquisition complements Charles River’s existing cell and gene therapy contract manufacturing capabilities and establishes an end-to-end, gene-modified cell therapy solution in the United States. In addition, the acquisition enables clients to seamlessly conduct analytical testing, process development, and manufacturing for advanced modalities with the same scientific partner, facilitating their goal of driving greater efficiency and accelerating their speed to market.

James C. Foster, Chairman, President and Chief Executive Officer of Charles River Laboratories, commented, “The addition of Vigene Biosciences’ extensive gene therapy capabilities further enhances Charles River’s position as a premier scientific partner for cell and gene therapies. It also accelerates our long-term revenue and earnings growth potential by expanding our portfolio in this emerging, high-growth market sector. We intend to continue to differentiate Charles River by delivering the scientific expertise and customizable approach required to support the complex needs of cell and gene therapy developers and innovators worldwide. Our goal is to become our clients’ scientific partner of choice for advanced drug modalities from discovery and non-clinical development to CGMP manufacturing.”

“We are pleased to welcome the exceptional team at Vigene to the Charles River family, and believe that together, we offer a compelling value proposition for clients and shareholders,” Mr. Foster concluded.

Vigene has become part of Charles River’s Manufacturing Solutions segment, which was renamed from Manufacturing Support to reflect the segment’s broader scientific capabilities with the addition of the Cell and Gene Therapy CDMO business.

Caution Concerning Forward-Looking Statements

This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “will,” “may,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements include statements in this news release regarding the acquisition of Vigene Biosciences, Inc., Charles River’s expectations with respect to the impact of Vigene on the Company, its product and service offerings, client perception, revenue, revenue growth rates, and earnings per share; Charles River’s projected future performance including revenue and earnings per share; as well as Charles River’s future growth in the area of cell and gene therapy CDMO services. Forward-looking statements are based on Charles River’s current expectations and beliefs, and involve a number of risks and uncertainties that are difficult to predict and that could cause actual results to differ materially from those stated or implied by the forward-looking statements. Those risks and uncertainties include, but are not limited to, our ability to successfully integrate Vigene, and risks and uncertainties associated with Vigene’s products and services. A further description of these risks, uncertainties, and other matters can be found in the Risk Factors detailed in Charles River’s Annual Report on Form 10-K as filed on February 17, 2021, and the Quarterly Report on Form 10-Q as filed on May 4, 2021, as well as other filings we make with the Securities and Exchange Commission. Because forward-looking statements involve risks and uncertainties, actual results and events may differ materially from results and events currently expected by Charles River, and Charles River assumes no obligation and expressly disclaims any duty to update information contained in this news release except as required by law.

About Charles River

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

Contacts

Investor Contact:
Todd Spencer
Corporate Vice President, Investor Relations
781.222.6455
todd.spencer@crl.com

Media Contact:
Amy Cianciaruso
Corporate Vice President, Public Relations
781.222.6168
amy.cianciaruso@crl.com

Childrens National Hospital joins pediatric health challenge led by Center for Advancing Innovation

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Leading children’s hospital provides clinical validation, IP for health challenge designed to advance pediatric innovation

Reinforcing its commitment to expanding innovation in pediatric care, Children’s National Hospital is joining with the Center for Advancing Innovation (CAI), and collaborators Resonance Philanthropies and Digital Infuzion, to launch the 2021-2022 Innovate Children’s Health Challenge to encourage the commercialization of technologies that improve children’s health care. This year’s event, Innovate Children’s Health II, focuses on technologies that address pandemic resiliency and prevention in the pediatric population and seeks to advance diagnostics, therapeutics and digital health tools that address pediatric mental health.

Led by CAI, a Maryland-based 501(c)(3) nonprofit, the initiative matches entrepreneurial talent with breakthrough inventions to launch startups and connect them with capital. For this challenge, more than 15 startups will compete for the opportunity to commercialize promising mental health solutions from a variety of research partners, including Children’s National. Nationally recognized for its expertise and commitment to innovation in pediatric care, Children’s National will contribute to the clinical validation of selected technologies.

“In addition to our role in providing clinical validation, this initiative provides the opportunity for intellectual property (IP) developed by leading clinicians at Children’s National Hospital, as well as other great pediatric institutions, to be considered for partnership with entrepreneurs who can help bring these technologies to market,” says Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National. “Our mission is to improve children’s health care and Innovate Children’s Health II is a great way to harness this trifecta model – innovation, talent and capital – in order to develop breakthrough solutions that address the unique needs of pediatric patients.”

There are three ways to participate in Innovate Children’s Health II:

  • Entrepreneurial-minded people – alone or as members of multidisciplinary teams – may compete to commercialize vetted inventions, selected out of patents and patent applications from CAI’s research partners by a committee of industry experts and potential investors.
  • Existing startups may enter the challenge with other public health-related inventions, including their own and/or others to which they have access.
  • Participants may submit ideas that they believe will improve emergency preparedness and pandemic response. CAI will help ideators create a business model to advance their solutions.

Eskandanian highlights the unique model of this challenge, which matches intellectual property with ambitious entrepreneurs and capital, as a critical step in leveraging existing patents that would help improve care for pediatric patients but, under traditional industry conditions, would not make it to market.

Inventors and technology licensing officers may submit inventions to be evaluated and made available for licensing to challenge winners. Innovate Children’s Health II will accept invention submissions until Sept. 1, 2021. Anyone with an entrepreneurial spirit and interest in stopping current and future pandemics is invited to sign up to learn more about the challengeTeams may also enroll in the challenge to choose a featured invention, bring in a third-party invention or get matched with an invention based on area of interest.

“The COVID-19 pandemic has made our children anxious, depressed and pessimistic about their futures. Through Innovate Children’s Health II, CAI and our strategic partner Children’s National, we will strive to give our children hope,” says Rosemarie Truman, founder and CEO of CAI. “We are grateful to Digital Infuzion and Resonance Philanthropies for their support, which makes this challenge possible.”

Eskandanian adds that supporting and expanding pediatric innovation is a key focus of the new Children’s National Research & Innovation Campus, the first-of-its-kind focused on pediatric health care innovation, with the first phase currently open on the former Walter Reed Army Medical Center campus in Washington, D.C. With its proximity to federal research institutions and agencies, universities, academic research centers, as well as on-site incubator Johnson and Johnson Innovation – JLABS, the campus provides a rich ecosystem of public and private partners which will help bolster pediatric innovation and commercialization.

Media Contact: Samantha Desmond | 713-524-8170


About The Center for Advancing Innovation (CAI)

The Center for Advancing Innovation (CAI) is a global public-private partnership, non-profit focused on creating a virtuous circle of innovation and driving growth breakthroughs through novel, creative paradigms, and models. CAI’s mission is to accelerate and increase the volume of technology commercialization to ignite entrepreneurship, bolster the global economy, and maximize the potential of promising inventions. CAI’s award-winning challenge-based accelerator, rigorous evidence-based due diligence, and capital-efficient lean management models serve to hyper-accelerated “gazelle” high-performing startups for outsized investor returns. For additional information about CAI, please visit http://www.thecenterforadvancinginnovation.org.


About Children’s National Hospital

Children’s National Hospital, based in Washington, D.C., celebrates 150 years of pediatric care, research and commitment to community. Volunteers opened the hospital in 1870 with 12 beds for children displaced after the Civil War. Today, 150 years stronger, it is among the nation’s top 10 children’s hospitals. It is ranked No.1 for newborn care for the fifth straight year and ranked in all specialties evaluated by U.S. News & World Report. Children’s National is transforming pediatric medicine for all children. In 2021, the Children’s National Research & Innovation Campus opened, the first in the nation dedicated to pediatric research. Children’s National has been designated three times in a row as a Magnet® hospital, demonstrating the highest standards of nursing and patient care delivery. This pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty care locations in the D.C. metropolitan area, including Maryland and Virginia. Children’s National is home to the Children’s National Research Institute and Sheikh Zayed Institute for Pediatric Surgical Innovation and is the nation’s seventh-highest NIH-funded children’s hospital. It is recognized for its expertise and innovation in pediatric care and as a strong voice for children through advocacy at the local, reg ional and national levels.

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