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|Item 7.01.|| |
Regulation FD Disclosure.
On August 1, 2022, GreenLight Biosciences Holdings, PBC (the “Company”), issued a press release announcing that the first commercial-scale engineering run for the production of the Company’s mRNA vaccine candidate has been completed through the Company’s relationship with Samsung Biologics Co., Ltd. A copy of the press release is set forth as Exhibit 99.1 and is incorporated by reference herein.
The information contained in this Item 7.01 of this Current Report on Form 8-K (this “report) and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Cautionary Note Regarding Forward Looking Statements
The press release attached as Exhibit 99.1 to this report contains, and our officers, directors and employees may make, “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 future operations, scientific developments or financial results of the Company, the Company’s relationship with Samsung Biologics and the manufacturing and scale-up of its product candidates. These forward-looking statements generally are identified by the words “aim to”, “believe,” “project,” “target”, “potential”, “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 the press release, including the evolution of the COVID-19 pandemic, the ability to develop COVID-19 vaccines that are more broadly protective against new variants and with longer-lasting effects, the ability to begin clinical trials for the Company’s COVID-19 booster vaccine candidate in 2022, the ability to rapidly develop and deploy vaccines on a commercial scale or at all, unanticipated challenges in advancing large-scale commercial production, the ability to scale up and the compatibility of the Company’s process to Samsung Biologics’ Songdo facility, the ability to replicate the production scale in future engineering runs, the acceptance of RNA-based technologies by regulators and the public, our ability to raise and productively deploy capital and the rate at which we can successfully bring products to market. Readers are cautioned not to put undue reliance on forward-looking statements and are encouraged to read the additional risks and uncertainties discussed in our periodic filings with the Securities and Exchange Commission under the heading “Risk Factors.” The Company assumes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. For additional information on the Company’s and potential risks associated with investing in the Company’s securities, please see our public filings at https://www.sec.gov/edgar/browse/?CIK=1822691&owner=exclude.
|Item 9.01|| |
Financial Statements and Exhibits.
|99.1||Press release, dated August 1, 2022, titled “GreenLight Biosciences and Samsung Biologics complete first commercial-scale engineering run for mRNA Covid-19 vaccine.”|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document).|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|GREENLIGHT BIOSCIENCES HOLDINGS, PBC|
|Date: August 1, 2022|
GreenLight Biosciences and Samsung Biologics complete first commercial-scale engineering run for mRNA Covid-19 vaccine
GreenLights messenger RNA production process is transferable to large-scale equipment and CMO facilities
Technology transfer and scale-up from lab bench to Samsungs commercial facility was completed in seven months
GreenLights 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 productionin a single facilityof both Drug Substance and LNP formulation, allowing the production of bulk Drug Product
Boston and Incheon, S. Korea, August 1, 2022(GLOBE NEWSWIRE)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 Samsungs commercial facility was completed in seven months, demonstrating platform adaptability and scalability.
GreenLights processfrom drug substance and lipid nanoparticle formulation to bulk drug productcan be completed in the same facility, an important capability. GreenLights mRNA synthesis reaction had a titer of 12g/L at commercial scale and produced 650g of mRNA.
The companys 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 GreenLights 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 GreenLights 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 worlds 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 companys platform is protected by numerous patents. GreenLights 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:
Head of Media Relations
For press, email: firstname.lastname@example.org
For investors, email: email@example.com
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:
Senior Director of Global Marketing Communications
Notes to editors
GreenLight and Samsung Biologics announced their partnership in December 2021: https://greenlightbiosciences.com/greenlight-biosciences-and-samsung-biologics-announce-collaboration/
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5f22986d-9b95-4bf5-9d6f-334ea48f22ba