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GreenLight Biosciences and Samsung Biologics complete first commercial-scale engineering run for mRNA Covid-19 vaccine

●  GreenLight’s messenger RNA production process is transferable to large-scale equipment and CMO facilities​

●  Technology transfer and scale-up from lab bench to Samsung’s commercial facility was completed in seven months

●  GreenLight’s mRNA synthesis reaction had a titer of 12g/L at a commercial scale and produced 650g of mRNA

●  The mRNA synthesis reaction was achieved without the need for customization, using standard equipment for Contract Development and Manufacturing Companies (CDMO)

●  Commercial-scale run has demonstrated production—in a single facility—of both Drug Substance and LNP formulation, allowing the production of bulk Drug Product

Boston and Incheon, S. Korea, August 1, 2022—GreenLight Biosciences (Nasdaq: GRNA), a biotechnology company dedicated to making ribonucleic acid (RNA) products affordable and accessible for human health and agriculture, and Samsung Biologics (KRX: 207940.KS), a leading global CDMO providing fully integrated end-to-end contract development and manufacturing services, announced the successful completion of the first commercial-scale engineering run for the companies’ mRNA production partnership.

Since the announcement of the strategic partnership between GreenLight Biosciences and Samsung Biologics in late 2021, technology transfer and scale-up from the lab bench to Samsung’s commercial facility was completed in seven months, demonstrating platform adaptability and scalability.

GreenLight’s process—from drug substance and lipid nanoparticle formulation to bulk drug product—can be completed in the same facility, an important capability. GreenLight’s mRNA synthesis reaction had a titer of 12g/L at commercial scale and produced 650g of mRNA.

The company’s RNA platform allowed GreenLight to move from conceptualizing an mRNA vaccine to delivering released clinical trial material in less than two years. With the demonstration at Samsung, and with GreenLight’s Covid booster vaccine clinical trial expected to start in 2022, GreenLight would be capable of supplying mRNA vaccine at a commercial scale.

“This demonstrates a major achievement in our continuing goal to offer one-stop end-to-end mRNA production from Drug Substance to Aseptic Fill Finish to commercial release, all from a single site, as we strive across our biomanufacturing network to fight the pandemic,” said John Rim, CEO and President at Samsung Biologics.

Earlier this year, Samsung Biologics completed the expansion of its mRNA drug substance manufacturing suite at its Songdo headquarters, where the company is now fully equipped to provide end-to-end mRNA production for clients.

“One of the greatest challenges when producing quality pharmaceuticals is advancing from a small lab to large-scale commercial production,” said GreenLight CEO Andrey Zarur. “We are grateful for the help and support of Samsung in demonstrating that our small mRNA process can scale in a linear fashion to the industrial scale that will be needed to help satisfy the vaccine needs of humanity.”

To date, all comparability data conforms with expected outcomes, indicating successful scale up and fit of GreenLight’s process to Samsung Biologics’ Songdo facility. A second engineering run will start in August, to implement improvements indicated by the first run and to demonstrate repeatability at scale​.

About GreenLight Biosciences

GreenLight Biosciences aims to address some of the world’s biggest problems by delivering on the full potential of RNA for human health and agriculture. Our RNA platform allows us to research, design, and manufacture for human, animal, and plant health. In human health, this includes messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company’s platform is protected by numerous patents. GreenLight’s human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review. GreenLight is a public benefit corporation that trades under the ticker GRNA on Nasdaq. For more information, visit https://www.greenlightbiosciences.com/

GreenLight Biosciences contact:

David Pesci

Head of Media Relations

[email protected]

For press, email: [email protected]

For investors, email: [email protected]

About Samsung Biologics Co., Ltd.

Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development and manufacturing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit samsungbiologics.com.

Samsung Biologics contact:

Claire Kim

Senior Director of Global Marketing Communications

[email protected]

Notes to editors

  1. GreenLight and Samsung Biologics announced their partnership in December 2021:
    https://greenlightbiosciences.com/greenlight-biosciences-and-samsung-biologics-announce-collaboration/
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GreenLight Biosciences announces new partnership with RiNova, CSO Italy, and UNAPera

NEW YORK, June 15, 2022—GreenLight Biosciences, RiNova, CSO Italy, and UNAPera signed an agreement to work toward the development and commercialization of GreenLight’s RNA-based agricultural pest solutions to farms in Italy.

The agreement aims to develop a collaboration for GreenLight’s proprietary, low- to no-residue RNA-based technology solutions designed to control fungi, viruses, and insects that attack crops, in line with the EU Farm to Fork strategy of reducing the use of traditional pesticides by 50 percent by 2030.

The memorandum of understanding, which represents one of the initiatives envisioned by the institutional mission of Italy’s Emilia-Romagna Region, will be valid for five years.

GreenLight is awaiting EPA approval for its first product, a solution that combats Colorado potato beetles, which create more than $500 million of crop damage and waste every year. The company is also currently in either field trials or regulatory trials for RNA-based solutions to a variety of pests, including:

Varroa destructor mite, which decimates and destroys honeybee hives, causes approximately $290 million in annual losses for beekeepers.

Botrytis, which affects soft fruit and other food crops, causes approximately $1.2 billion annual losses for farmers.

Powdery mildew, which affects grapes and other fruit, causes approximately $1.4 billion in annual losses for farmers and vintners.

Introducing RNA-based pest-fighting technologies into European agriculture will help EU countries and other European nations to use innovative, non-traditional methods with a novel model of action.

Field trials of GreenLight’s Colorado potato beetle solution have shown low- to no-residues, offering a variety of environmental and consumer benefits. In addition, although conventional pesticides can require special protective equipment for farmworkers, it is anticipated that just basic work gloves will be required for these products.

GreenLight Biosciences, a public benefit corporation, also has collaborative partnerships in place with Serum Institute of India, Samsung Biologics, IAVI, and other prominent global organizations.

About GreenLight Biosciences

GreenLight Biosciences aims to address some of the world’s biggest problems by delivering on the full potential of RNA for human health and agriculture. Our RNA platform allows us to research, design, and manufacture for human, animal, and plant health. In human health, this includes messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company’s platform is protected by numerous patents. GreenLight’s human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review. GreenLight is a public benefit corporation that trades under the ticker GRNA on Nasdaq. For more information, visit https://www.greenlightbiosciences.com/

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YonHap: GreenLight in mRNA deal with Samsung Biologics

Greenlight Biosciences’ deal with Samsung Biologics to establish a one-stop production capability for manufacturing messenger RNA (mRNA) vaccines was reported by Yonhap News Agency.

Samsung has completed the addition of the new mRNA vaccine substance production capability at its plant in Songdo, Incheon, 40 kilometers west of Seoul, and began producing drug substances for COVID-19 vaccines of GreenLight Biosciences Inc. of the United States late last month.

Samsung Biologics, a leading contract development and manufacturing organization (CDMO), signed a drug substance supply agreement with the American biotech company last year

Read the full article here.

You can read more about our deal with Samsung Biologics in this article by BioProcess.

Find out more about how GreenLight manufactures RNA.

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GreenLight’s honeybee-saving RNA solution named finalist in World Changing Ideas Award

BOSTON, May 10, 2022—An RNA-based solution by GreenLight Biosciences designed to protect honeybees from the Varroa destructor mite was named a finalist by Fast Company for its 2022 World Changing Ideas Awards.

This is the first RNA-based solution that directly targets the mites, which have been detected in 90% of U.S. hives and which beekeepers call the primary threat to honeybee colonies today. In field trials, the solution lowers mite levels with strong efficacy compared to a leading chemical pest control.

“The technology at GreenLight, we’re testing it now, and we’ve seen it work,” said Barry Hart, owner of Hart Honey Farms in Georgia. A beekeeper since 1985, Hart said Varroa mites have decimated many of his hives.

GreenLight’s Varroa mite product candidate is currently undergoing tests in several states and is scheduled to be submitted for EPA approval in 2022.

About 3 million commercial honeybee colonies in the United States contribute to pollinating more than 100 crops annually, worth an estimated $15 billion. The Varroa mite reproduces in the same beehive cells as gestating bee larvae, grows up to parasitically feed on honeybees, and while doing so spreads disease, destroying colonies across the globe.

A limited number of chemical treatments are the current weapons in the fight against the Varroa mite. However, the traditional treatments come with side effects that may include bee death. Varroa mites have also developed resistance to several existing traditional chemical pesticides, which also require farmers to wear special protective gear and goggles to apply. GreenLight’s patented RNA technology only requires gloves.

“Crops pollinated by honeybees make up roughly a third of the food eaten by Americans, so declining populations of honeybees could have major consequences for food supply,” said Andrey Zarur, CEO of GreenLight Biosciences. “Our mission is to protect the species safely and effectively, and we are excited by Fast Company’s recognition for our achievements.”

GreenLight and other Fast Company nominees and award winners can be found here.

About GreenLight Biosciences

GreenLight Biosciences aims to address some of the world’s biggest problems by delivering on the full potential of RNA for human health and agriculture. Our RNA platform allows us to research, design, and manufacture for human, animal, and plant health. In human health, this includes messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company’s platform is protected by numerous patents. GreenLight’s human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review. GreenLight is a public benefit corporation that trades under the ticker GRNA on Nasdaq. For more information, visit https://www.greenlightbiosciences.com/

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International crop network validates ledprona as a new Mode of Action group

An effective and novel pest-management solution with low-to-no residues aimed at the Colorado potato beetle (CPB) has received validation as a new mode of action (MoA) by the Insecticide Resistance Action Committee.

Ledprona, the active ingredient in GreenLight’s CalanthaTM product, was approved as a new mode of action in the recent winter meeting of IRAC, an international association of crop-protection companies that focuses on resistance management and sustainable agriculture.

The first foliar-applied, dsRNA-based bioinsecticide that provides effective control of CPB, CalanthaTM is expected to be registered in the United States this year. The Colorado potato beetle (Leptinotarsa decemlineata) ravages plants like potatoes and eggplant and accounts for more than $500 million in annual crop loss worldwide. 

For decades, insect resistance to pesticides has challenged growers. Using integrated pest management, which includes rotating insecticides, farmers and agronomists can prolong the useful lifespan of crop treatments. GreenLight’s product is designed to work well with standard growers’ programs to control first- and second-generation Colorado potato beetle infestations.

CalanthaTM has a unique mode of action among chemical and biological insecticides, which will provide farmers with a new tool aimed at protecting potato and eggplant fields from the Colorado potato beetle and support their efforts at resistance management. 

Ledprona, expected to be classified as IRAC MoA group 35 (RNAi-mediated targeted suppressors), specifically targets only CPB, causing the beetle to stop eating and expire from accumulation of its own metabolic waste. Because it is based on double-stranded ribonucleic acid, CalanthaTM degrades quickly in the environment, supports biodiversity, and is an example of the next generation of eco-friendly crop-protection products. 

The Insecticide Resistance Action Committee helps growers around the world by developing mode-of-action classification schemes; identifying new technologies for insect, mite, and tick control products; and  implementing insecticide resistance management strategies for crop protection, plant biotechnology, and public health.

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Co-developer of COVID-19 Vaccine Joins GreenLight Advisory Board

Dr. Graham is an author on more than 500 scientific publications and a thought leader on emerging viral diseases and pandemic preparedness. He was involved in the advanced evaluation of vaccines and monoclonal antibodies for HIV, Ebola, and Chikungunya. He also developed novel vaccines for RSV, influenza, Zika, paramyxoviruses, and coronaviruses including the first COVID-19 vaccine and monoclonal antibody to enter clinical testing and that subsequently achieved Emergency Use Authorization and licensure.

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GreenLight agrees to establish field station in Spain to boost research and development for key plant health projects

Boston, February 4, 2022—GreenLight Biosciences, PBC, a biotechnology company focused on RNA research, design, and manufacturing for human, animal, and plant health, today announced its agreement to operate a field research station in Spain.  

Located south of Seville, a key agricultural area with intensive year-round production, the farmland will allow GreenLight to accelerate its transition of research and discovery compounds into the field.

“The versatility of this site and its climate will enable us to conduct broad-spectrum testing for GreenLight’s emerging portfolio and support key projects, whether it’s plant diseases or insects,” says Andreas Hopf, VP of Plant Health Product Development. 

GreenLight intends to lease about 10 to 20 hectares to support field trials, plant pathogens, entomology, and office space. “Having a research farm allows us to conduct our field work much more efficiently,” says Hopf. “We will have the core competencies to take on external compounds and technologies to onboard them onto our pipeline.”

The expansion will initially support GreenLight’s work in Europe to address crop challenges caused by powdery mildew, botrytis, fusarium, and the Colorado potato beetle.

About GreenLight

Founded in 2008, GreenLight aims to address some of the world’s biggest problems by delivering on the full potential of RNA for human health and agriculture. In human health, this includes mRNA vaccines and therapeutics. In agriculture, this includes RNA  to protect honeybees and a range of crops. The company’s breakthrough cell-free RNA manufacturing platform, which is protected by numerous patents, allows for cost-effective production of RNA. GreenLight’s human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review. GreenLight is a public benefit corporation that trades under the ticker GRNA on Nasdaq. For more information, visit https://www.greenlightbiosciences.com/

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and GreenLight assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

Thomas Crampton

SVP & Head of Corporate Affairs

GreenLight Biosciences

[email protected]

+44 7826 995794

+1-914-202-2762

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A group of bees inside a hive at Barry Hart's Georgia farm.

GreenLight Biosciences begins trading today as Nasdaq: GRNA on the closing of its business combination with Environmental Impact Acquisition Corp.

BOSTON, February 3, 2022—GreenLight Biosciences (“GreenLight”), a biotechnology company dedicated to making ribonucleic acid (RNA) products affordable and accessible for human health and agriculture, and Environmental Impact Acquisition Corp. (Nasdaq: ENVI) (“ENVI”), a special purpose acquisition company, yesterday announced the closing of their previously announced business combination. 

In connection with the closing, the company changed its name to GreenLight Biosciences Holdings, public-benefit corporation, with shares of Class A common stock and public warrants trading today on Nasdaq under the ticker symbols “GRNA” and “GRNA.WS” respectively. The business combination was approved at a special meeting of ENVI stockholders on February 1, 2022.

GreenLight harnesses the power of biology to develop RNA-based solutions for some of humanity’s greatest challenges in human health through mRNA vaccines and therapeutics and in food production through RNA crop-protection products. The company’s breakthrough cell-free RNA manufacturing platform, which is protected by numerous patents, allows for cost-effective and scalable production of RNA.

“Today an exciting new chapter begins as we become a publicly listed company and public-benefit corporation,” said CEO Andrey Zarur. “We are thrilled to accelerate commercialization by attracting the talent, investing in the tools, and scaling our manufacturing infrastructure to continue developing our platform for design, development, and production of unprecedented new applications for RNA.”

“In creating ENVI, our goal was to partner and combine with a high-growth, technology-rich business, propelled by a large market opportunity and a business model supporting critical sustainability initiatives,” said Dan Coyne, CEO of Environmental Impact Acquisition Corp. “GreenLight has an impressive pipeline of RNA products spanning human, animal, and plant health, and its exceptional team understands what it takes to deliver breakthrough technology to market. We are extremely pleased to have completed this transaction, resulting in GreenLight becoming a public company.”

SVB Leerink and Credit Suisse served as financial and capital markets advisors to GreenLight and co-placement agents on the PIPE transaction. Foley Hoag LLP served as legal advisor to GreenLight. Canaccord Genuity served as financial advisor and Latham & Watkins LLP served as legal advisor to Environmental Impact Acquisition Corp. 

To celebrate the completion of the business combination, GreenLight will ring the closing bell at Nasdaq at 4 p.m. ET on February 8, 2022. 

About GreenLight Biosciences

GreenLight Biosciences aims to address some of the world’s biggest problems by delivering on the full potential of RNA for human health and agriculture. Our RNA platform allows us to research, design, and manufacture for human, animal, and plant health. In human health, this includes mRNA vaccines and therapeutics. In agriculture, this includes RNA  to protect honeybees and a range of crops. The company’s platform is protected by numerous patents. GreenLight’s human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review. GreenLight is a public benefit corporation that trades under the ticker GRNA on Nasdaq.  For more information, visit GreenLight’s website.

About Environmental Impact Acquisition Corporation

Environmental Impact Acquisition Corp. is a Special Purpose Acquisition Company. The Company is sponsored by CG Investments Inc. VI, an affiliate of Canaccord Genuity, which manages several investment vehicles.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, with respect to the proposed transaction between GreenLight Biosciences, Inc. (“GreenLight”) and Environmental Impact Acquisition Corp. (“ENVI”). These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to the risk that the transaction may not be completed in a timely manner or at all, which may adversely affect the price of ENVI’s securities and the effect of the announcement or pendency of the transaction on GreenLight’s business relationships, operating results, and business generally. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and ENVI and GreenLight assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

Media contact:

Thomas Crampton

SVP & Head of Corporate Affairs

GreenLight Biosciences

[email protected]

+44 7826 995794

+1-914-202-2762

Investor contact:

[email protected]

https://investors.greenlightbio.com/
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Environmental Impact Acquisition Corporation approval obtained; GreenLight Biosciences set to begin trading under Nasdaq: GRNA on February 3, 2022

Boston, February 2, 2022—Environmental Impact Acquisition Corporation (NASDAQ: ENVI), a publicly-traded special purpose acquisition company, announced today that its business combination with Greenlight Biosciences was approved in a shareholder vote held yesterday, with 80.7% of shareholders participating in the vote and 78.6% voting in favor of the combination.

Subject to the satisfaction or waiver of the other customary closing conditions, Environmental Impact Acquisition Corp. anticipates closing the business combination today. In connection with the closing, the company will change its name to GreenLight Biosciences Holdings, public-benefit corporation, and the combined company’s shares of Class A common stock and public warrants are expected to trade on the Nasdaq exchange beginning on February 3, 2022, under the ticker symbols “GRNA” and “GRNA.WS,” respectively.

“Today marks an important milestone, and I am thrilled to work with our teams as we develop new applications for our RNA platform,” said Andrey Zarur, CEO of GreenLight.

Investors include Serum Life Sciences, Fall Line Capital, Viceroy Capital, S2G Ventures, Cormorant Asset Management, Morningside Venture Investments, Hudson Bay Capital, BNP Paribas Ecosystem Restoration Fund, The Jeremy and Hannelore Grantham Environmental Trust, Continental Grain Company, Pura Vida Investments LLC, Xeraya Capital, and MLS Fund II/Spruce.

Canaccord Genuity served as financial advisor and Latham & Watkins LLP served as legal advisor to Environmental Impact Acquisition Corp.  SVB Leerink and Credit Suisse served as financial and capital markets advisors to GreenLight and co-placement agents on the PIPE transaction. Foley Hoag LLP is served as legal advisor to GreenLight.

About GreenLight

Founded in 2008, GreenLight aims to address some of the world’s biggest problems by delivering on the full potential of RNA for human health and agriculture. In human health, this includes mRNA vaccines and therapeutics. In agriculture, this includes RNA  to protect honeybees and a range of crops. The company’s breakthrough cell-free RNA manufacturing platform, which is protected by numerous patents, allows for cost-effective production of RNA. GreenLight’s human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review. For more information, visit https://www.greenlightbiosciences.com/

In August 2021, GreenLight Biosciences announced plans to become publicly listed through a business combination with Environmental Impact Acquisition Corp. (Nasdaq: ENVI).

For more information, visit greenlightbiosciences.com

About Environmental Impact Acquisition Corporation

Environmental Impact Acquisition Corp. is a Special Purpose Acquisition Company. The Company is sponsored by CG Investments Inc. VI, an affiliate of Canaccord Genuity, which manages several investment vehicles.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, with respect to the proposed transaction between GreenLight Biosciences, Inc. (“GreenLight”) and Environmental Impact Acquisition Corp. (“ENVI”). These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to the risk that the transaction may not be completed in a timely manner or at all, which may adversely affect the price of ENVI’s securities and the effect of the announcement or pendency of the transaction on GreenLight’s business relationships, operating results, and business generally. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and ENVI and GreenLight assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

Thomas Crampton

SVP & Head of Corporate Affairs

GreenLight Biosciences

[email protected]

+44 7826 995794

+1-914-202-2762

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