Investors, Press releases, Products GreenLight Biosciences Outlines Development Strategy and Highlights Portfolio Updates at Human Health R&D Day Progressing human health pipeline conferring mRNA platform advantages for infectious disease and personalized oncology medicines; pursuing capital efficient strategy targeting unmet medical needs, in both the developed and lower- and middle-income countries (LMICs), pairing focused R&D spend with partnerships. Accelerating development of next-generation COVID vaccine candidate; decision to advance universal pan-sarbecovirus vaccine candidate in place of mono-valent Wuhan based antigen. Preclinical data on shingles vaccine candidate(s) showing high and durable antibody response, strong cellular T-cell response, and durable memory response. Collaboration with EpiVax therapeutics to develop personalized mRNA cancer vaccine candidates. R&D Day webcast to begin at 10:30 am ET today. BOSTON, March 9, 2023 —GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to deliver on the full potential of RNA to address some of the world’s toughest problems in human health and agriculture, will today outline its pipeline strategy and R&D progress for mRNA-based solutions during its Human Health R&D Day being held today, March 9, 2023 at 10:30 a.m. ET in Lexington, MA. GreenLight today is sharing the key pillars of its human health strategy: Developing vaccines for infectious diseases, especially those addressing unmet medical needs in lower- and middle-income countries. Consistent with its public benefit corporation status, Greenlight is striving to support global, sustainable vaccine access and pandemic response readiness. Developing innovative products to address unmet medical needs in oncology and autoimmune diseases. This work has begun with the collaboration with EpiVax Therapeutics to co-develop personalized cancer vaccines.Continued advancement of GreenLight’s mRNA technology platform through innovations and to seek potential partnerships with pharmaceutical and biotechnology companies. As previously announced, GreenLight received approval from the Rwanda Food and Drugs Authority (Rwanda FDA) to initiate a Phase I/II study of its GLB-COV2-043 vaccine booster candidate. However, given the global shift in the standard of care for COVID vaccination to the Wuhan/Omicron bivalent vaccine, and new availability of the bivalent vaccine in Rwanda, GreenLight has decided to proceed with its pan-sarbecovirus vaccine candidate instead of the GLB-COV2-043 (monovalent) vaccine candidate as originally planned. GreenLight is accelerating the development of its pan-sarbecovirus vaccine candidate that is potentially capable of broader coverage and predictive protection and plans to make a follow-up filing on this candidate to the Rwanda FDA and the Rwanda National Ethics Committee (RNEC). GreenLight will be working expeditiously and closely with its Rwandan partners to advance these efforts over the coming months and are starting conversations with potential partners in other countries that have expressed interest in supporting its development and clinical path for a broader pan-sarbecovirus vaccine. “We are excited to advance our pan-sarbecovirus vaccine candidate that may allow us to bring a next generation, innovative Covid-19 vaccine to market in Rwanda, and the rest of the world, earlier than we anticipated,” Andrey Zarur, CEO of GreenLight. Regarding its shingles program, GreenLight is excited to share promising new pre-clinical data. GreenLight has selected a lead candidate to progress towards clinical development after evaluation of multiple antigen designs and formulations. Based on pre-clinical data, our lead pre-clinical candidate induced antibody levels and memory B and T cell responses in mouse in vivo studies similar to the current standard of care. In addition, the pre-clinical data showed that the lead candidate induced T cell responses in mouse in vivo studies stronger than the current standard of care. This pre-clinical candidate is advancing towards development candidate nomination. Serum Institute of India Private Limited will be responsible for the clinical development, manufacturing, and commercialization of the vaccine candidate in lower- and middle- income countries under its license agreement with GreenLight Biosciences. GreenLight retains the clinical development, manufacturing, and commercial rights in the developed world. GreenLight and EpiVax Therapeutics are partnering to create a proprietary personalized cancer vaccine platform which combines GreenLight’s mRNA design and manufacturing expertise with EpiVax Therapeutic’s neoantigen discovery platform. “We continue to be excited about expediting the development of personalized cancer vaccines in collaboration with EpiVax Therapeutics.” said Kimberly Warren, Chief Business Officer of GreenLight Biosciences. “While our initial focus will be on bladder cancer, the 4th most common cancer in men, we plan on working to shape a pipeline of compelling personalized cancer vaccine candidates that will help build a future of more timely and accessible treatments.” The human health R&D Day is the second in a series providing comprehensive updates on GreenLight’s R&D strategy and progress. The previous session, which focused on GreenLight’s Plant Health pipeline, was held on Tuesday, March 7, 2023. A live webcast of the event will be available live and can be accessed via the Investors section of the Company’s website at www.greenlightbiosciences.com. Registration is available here: https://www.greenlightbiosciences.com/rdshowcase/ and a replay of both events will be available at https://investors.greenlightbio.com for approximately 30 days. About GreenLight Biosciences GreenLight Biosciences (Nasdaq: GRNA) 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. Availability of Other Information About GreenLight Biosciences Investors and others should note that we communicate with our investors and the public using our website (www.greenlightbiosciences.com), the investor relations website (https://investors.greenlightbio.com/), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that GreenLight posts on these channels and websites could be deemed to be material information. As a result, GreenLight encourages investors, the media, and others interested in GreenLight to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on GreenLight’s investor relations website and may include additional social media channels. The contents of GreenLight’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the success, cost and timing of our research and development activities in our plant and human health programs, the timing of regulatory submissions and approvals, our ability to commercialize our products, the acceptance of RNA-based technologies by regulators and the public, including the timing it takes to receive regulatory approval, the success, cost and timing of our clinical trials, including estimates regarding when patients will be enrolled, our ability to progress our candidates into the clinic, if at all, the timing to commence future clinical trials, our projected cash runway and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in our Quarterly Reports on Form 10-Q, periodic filings on Form 8-K, and any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by current macroeconomic conditions and the ongoing COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. For additional information on GreenLight and potential risks associated with investing, please see our public filings at https://www.sec.gov/edgar/browse/?CIK=1822691&owner=exclude. Contacts: Media Contact: Thomas CramptonSVP Corporate AffairsGreenLight Biosciences [email protected] Investor Contact: Ingrid FungDirector, Enterprise Operations and Strategy & Head of Investor Relations GreenLight Biosciences [email protected] 9 March 2023 By Patrick 0 Comments
Investors, Press releases, Products GreenLight Biosciences Outlines Development Strategy and Highlights Portfolio Updates at Plant Health R&D Day BOSTON, March 7, 2023 —GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to deliver on the full potential of RNA to address some of the world’s toughest problems in human health and agriculture, will today outline its pipeline strategy and R&D progress for dsRNA based crop protection and plant delivery innovations focused on addressing food security with innovative and sustainable solutions during its Plant Health R&D Day being held today, March 7th, 2023 at 10:30 a.m. ET in Research Triangle, North Carolina. “GreenLight is taking an innovative approach to advancing novel double-stranded RNA (dsRNA) solutions for numerous agricultural applications with advantages in speed of discovery/development, cost, quality and delivery. We have advanced our company’s portfolio strategy, target product profiles, and delivery capability all to meet the global challenges we face in the quest to grow food sustainably.” said Andrey Zarur, CEO of GreenLight Biosciences. “We have done this all with an eye on expanding potential addressable markets for our product portfolio and a focus on the potential benefits that our sustainable technologies could have on society.” Sustainable innovations that address emerging resistance, food security, and agricultural impacts on biodiversity As a leader in RNA innovation for agriculture, the Company is building on its existing rapid design, development and iteration capabilities for dsRNA by expanding product applications and delivery capabilities. The technological progress to be shared in today’s showcase enables GreenLight Biosciences to work towards unlocking access to the broader global insecticides and fungicides market worth $39B1,2, and the global herbicides market valued at $35.72B3. “Farmers need products that appropriately solve the challenges they face in-field, all while helping to improve the overall sustainability of agriculture,” said Mark Singleton, Chief Commercial Officer and General Manager of Plant Health. “GreenLight Biosciences is fully committed to delivering products that address some of the major challenges faced by farmers, such as increased pest resistance, tightening regulatory environments, and demands by consumers to reduce chemical loads in foods. We expect that our rapid dsRNA development and production capabilities, coupled with novel delivery technologies, will enable us to develop sustainable solutions across all crop inputs segments and help reduce agricultural impact on biodiversity.” Plant Health Strategy & Portfolio Updates Today, at GreenLight’s R&D Showcase, the Company will outline a long-term strategy to progress its Plant Health portfolio and highlight progress in its R&D pipeline that it anticipates will help farmers expand their suite of tools to preserve yield potential as threats from insects, disease, and weeds increase, including: Actively preparing for commercial launch prior to end of 2023 of our leading dsRNA solution, Calantha™, subject to regulatory approvalThe registration dossier for our RNA solution that targets the varroa destructor mite was submitted to the EPA in February 2023 and is now under reviewExpansion of dsRNA-based fungal, insecticide, and acaricide programs into multi-target applicationsPlant disease program data showing formulated dsRNA performance in-field providing control of grey mold and powdery mildew equivalent or better than conventional chemical standards at commercially relevant spray intervalsData demonstrating functional delivery of dsRNA into plants; showing decreased fusarium disease severity in lettuce seed treatment trials, and preliminary indications of herbicidal activity “These highlights are representative of our robust dsRNA pipeline, delivery capability and our ongoing commitment to delivering on the potential of RNA to provide farmers with the tools they need to increase productivity, profitability, and sustainability in the face of climate events and increasing resistance to conventional crop protection products,” said Zarur. “We look forward to advancing these innovations to ensure that farmers have access to technology that benefits their production, and to help create healthy people and planet through RNA innovation.” The Plant Health R&D Day is the first in a series providing comprehensive updates on GreenLight’s R&D strategy and progress. The next session will focus on the Company’s Human Health portfolio and will be hosted on Thursday, March 9th, 2023, at GreenLight Biosciences Headquarters in Lexington, MA. A webcast of both events will be available live and can be accessed via the Investors section of the Company’s website at www.greenlightbiosciences.com. Registration is available here: https://www.greenlightbiosciences.com/rdshowcase/ and a replay of the webcasts will be available at https://investors.greenlightbio.com for approximately 30 days. A copy of the presentation can be found here: https://investors.greenlightbio.com/static-files/bb34331c-447f-4180-9663-96ba5a227542 Sources: 1. https://www.marketsandmarkets.com/Market-Reports/fungicides-356.html 2. https://www.marketsandmarkets.com/Market-Reports/insecticide-market-142427569.html 3. https://www.businesswire.com/news/home/20210916005897/en/Global-47.09-Bn-Herbicides-Market-to-2025-2030—ResearchAndMarkets.com About GreenLight Biosciences GreenLight Biosciences (Nasdaq: GRNA) 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. Availability of Other Information About GreenLight Biosciences Investors and others should note that we communicate with our investors and the public using our website (www.greenlightbiosciences.com), the investor relations website (https://investors.greenlightbio.com/), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that GreenLight posts on these channels and websites could be deemed to be material information. As a result, GreenLight encourages investors, the media, and others interested in GreenLight to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on GreenLight’s investor relations website and may include additional social media channels. The contents of GreenLight’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the success, cost and timing of our research and development activities in our plant and human health programs, the timing of regulatory submissions and approvals, our ability to commercialize our products, the acceptance of RNA-based technologies by regulators and the public, including the timing it takes to receive regulatory approval, the success, cost and timing of our clinical trials, including estimates regarding when patients will be enrolled, when data will be reported for our ongoing clinical trials and timing to commence future clinical trials, our projected cash runway and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in our Quarterly Reports on Form 10-Q, periodic filings on Form 8-K, and any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by current macroeconomic conditions and the ongoing COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. For additional information on GreenLight and potential risks associated with investing, please see our public filings at https://www.sec.gov/edgar/browse/?CIK=1822691&owner=exclude. Contacts: Media Contact: Thomas CramptonSVP Corporate AffairsGreenLight Biosciences [email protected] Investor Contact: Ingrid FungDirector, Enterprise Operations and Strategy & Head of Investor Relations GreenLight Biosciences [email protected] 7 March 2023 By Patrick 0 Comments
Investors, Press releases GreenLight Biosciences to Host R&D Day Series on Plant and Human Health Development Strategy BOSTON, March 1, 2023 —GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to deliver on the full potential of RNA to address some of the world’s toughest problems in human health and agriculture, today announced it will host a two-part R&D Day Series for analysts and investors. Session One: Plant Health Date: Tuesday, March 7th, 2023Time: 10:30 a.m. – 1:30 p.m. ETLocation: GreenLight Biosciences North Carolina Biotech Center in Research Triangle Park, NC Session Two: Human Health Date: Thursday, March 9th, 2023Time: 10:30 a.m. – 1:30 p.m. ETLocation: GreenLight Biosciences Headquarters in Lexington, MA The event will provide a comprehensive update on GreenLight’s R&D strategy and progress. A webcast of both events will be available live and can be accessed via the Investors section of the Company’s website at www.greenlightbiosciences.com. Registration is available here: https://www.greenlightbiosciences.com/rdshowcase/ and a replay of the webcasts will be available at https://investors.greenlightbio.com for approximately 30 days. About GreenLight Biosciences 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 messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company’s breakthrough cell-free RNA 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, including our latest investor presentation and other materials, please visit https://www.greenlightbiosciences.com/. Availability of Other Information About GreenLight Biosciences Investors and others should note that we communicate with our investors and the public using our website (www.greenlightbiosciences.com), the investor relations website (https://investors.greenlightbio.com/), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that GreenLight posts on these channels and websites could be deemed to be material information. As a result, GreenLight encourages investors, the media, and others interested in GreenLight to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on GreenLight’s investor relations website and may include additional social media channels. The contents of GreenLight’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. Contacts: Media Contact: Thomas CramptonSVP Corporate AffairsGreenLight Biosciences [email protected] Investor Contact: Ingrid FungDirector, Enterprise Operations and Strategy & Head of Investor Relations GreenLight Biosciences [email protected] 1 March 2023 By Patrick 0 Comments
Investors, Press releases, Products GreenLight Biosciences receives approval to initiate Phase I/II clinical trial of Covid-19 mRNA vaccine candidate The Rwanda FDA has given regulatory approval to GreenLight to start a Phase I/II clinical trial of its Covid-19 vaccine candidate in Rwanda. This phase I/II clinical trial is the first step in GreenLight’s integrated strategy of bringing a universal Covid-19 mRNA vaccine to market globally. By initiating this first-in-human clinical study in Rwanda, GreenLight is demonstrating its commitment to partner with the people of Africa in bringing advanced health technologies to the continent. Kigali, Rwanda, and Lexington, MA February 1, 2023—GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to deliver on the full potential of RNA to address some of the world’s toughest problems in human health and agriculture, today announced that it has received regulatory approval from the Rwanda Food and Drugs Authority (Rwanda FDA) to start a Phase I/II clinical trial of its vaccine candidate against Covid-19, as a booster to previously vaccinated individuals. Preparations for the trial are underway. Mark Dybul, chair of GreenLight’s Human Health Scientific Advisory Board, and former executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, said: “Covid-19 continues to be a significant global health issue. Efforts to develop novel vaccines that are longer-lasting and effective against a broad spectrum of variants are necessary to minimize the risk of disease resurgence or dangerous mutations of the SARS-CoV-2 virus. It is especially important to develop vaccines that are globally affordable and scalable. GreenLight’s efforts to initiate this clinical study in Rwanda show the company’s commitment to support Africa’s goal of affordable vaccine self-sufficiency. Andrey Zarur, GreenLight’s CEO, said: “This clinical trial marks the necessary first step toward developing an integrated, universal strategy against Covid-19. Our previously announced collaboration with the U.S. National Institutes of Health to develop a universal Covid-19 vaccine, and our previously reported scalable mRNA manufacturing process, will enable us to address this disease in a more effective manner.” “We are delighted to receive approval from the Rwanda Food and Drugs Authority to start our Covid-19 mRNA vaccine candidate trial. Approval to begin clinical trials in humans, from a national regulatory authority, is a significant milestone for GreenLight’s human health business. This demonstrates our commitment of supporting vaccine and therapeutics accessibility for low- and middle-income countries.” We share the Rwandan government’s vision that everybody should have access to the best healthcare. A Phase I/II trial of our Covid-19 vaccine candidate is just the start. Rwanda is at the forefront of bringing end-to-end research and development to Africa. We look forward to deepening our partnership so that we can play our part, and help Africa become self-sufficient in vaccines.” In addition to its mRNA Covid-19 vaccine candidate, GreenLight is developing mRNA vaccines against other infectious diseases, such as shingles (in collaboration with Serum Institute of India Pvt. Ltd.), and cancer (in collaboration with EpiVax Therapeutics), as well as RNA-based therapies against genetic disorders, such as sickle-cell disease. Further details of the Covid-19 vaccine candidate study can be found at: https://www.clinicaltrials.gov/ct2/show/NCT05602961. Notes to editors GreenLight’s mRNA vaccine candidate, GLB-COV2-043, contains mRNA, encoding the SARS-CoV-2 full-length spike protein from the Wuhan strain, formulated in a lipid nanoparticle. This vaccine candidate is part of GreenLight’s broader Covid-19 strategy, which includes the development of a universal Covid-19 vaccine with broader and more durable protection. Pending positive safety and immunogenicity results from this Phase I/II clinical trial, GreenLight will look to continue development in Africa on potential next-generation Covid-19 vaccine candidates. The Phase I/II study is designed to assess safety and immunogenicity as measured by humoral and cellular immune-response endpoints. Enrollment will be open to eligible adults who have received a 2-dose priming course of the mRNA BNT162b2/Comirnaty vaccine or a 2-dose priming and a third injection (i.e. as a booster) of the same mRNA vaccine. Participants will be evaluated in four cohorts, with the GreenLight vaccine candidate being administered in 15 microgram, 30 microgram, 60 microgram and 90 microgram doses, respectively. Each cohort will include 10 participants receiving the GreenLight vaccine candidate. Further details on GreenLight’s pipeline and plans can be found at investors.greenlightbio.com. Platform Life Sciences, in collaboration with GreenLight and leading clinical investigators in Rwanda, will conduct the trial. About GreenLight Biosciences 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 messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company’s breakthrough cell-free RNA 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, including our latest investor presentation and other materials, please visit https://www.greenlightbiosciences.com/. Availability of Other Information About GreenLight Biosciences Investors and others should note that we communicate with our investors and the public using our website (www.greenlightbiosciences.com), the investor relations website (https://investors.greenlightbio.com/), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that GreenLight posts on these channels and websites could be deemed to be material information. As a result, GreenLight encourages investors, the media, and others interested in GreenLight to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on GreenLight’s investor relations website and may include additional social media channels. The contents of GreenLight’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the success, cost and timing of our research and development activities in our plant and human health programs, the acceptance of RNA-based technologies by regulators and the public, the success, cost and timing of our clinical trials, including estimates regarding when patients will be enrolled, when data will be reported for our ongoing clinical trials and timing to commence future clinical trials, our projected cash runway and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in our Quarterly Reports on Form 10-Q, periodic filings on Form 8-K, and any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by current macroeconomic conditions and the ongoing COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. For additional information on GreenLight and potential risks associated with investing, please see our public filings at https://investors.greenlightbio.com/financial-information/sec-filings. Media Contact: Thomas Crampton SVP Corporate Affairs GreenLight Biosciences [email protected] Investor Contact: Ingrid Fung Director, Enterprise Operations and Strategy & Head of Investor Relations GreenLight Biosciences [email protected] 1 February 2023 By Patrick 0 Comments
Investors, Press releases, Products GreenLight Biosciences and EpiVax Therapeutics Sign Exclusive Collaboration Agreement to Develop Personalized Cancer Vaccines The effort will combine GreenLight’s mRNA design and manufacturing expertise with EpiVax’s advanced Ancer® pipeline for personalized cancer vaccine designEpiVax Therapeutics, Inc. will contribute a proprietary set of immunoinformatics tools for rapidly identifying and differentiating highly immunogenic neo-antigens from epitopes that induce immune toleranceGreenLight will contribute proprietary RNA technology allowing mRNA design, formulation, and manufacturing BOSTON and PROVIDENCE January 9, 2022: GreenLight Biosciences Holdings, PBC (Nasdaq:GRNA), and EpiVax Therapeutics Inc, today announced that they have signed an exclusive collaboration agreement to jointly develop and commercialize personalized mRNA-based vaccine candidates for cancers. GreenLight Biosciences is a public benefit corporation striving to bring effective and safe RNA-based solutions to make food clean and affordable for everyone and dedicated to developing health solutions for every person on our planet. EpiVax Theraeutics Inc. is a biotechnology company with extensive experience in immune-engineering more effective vaccines that recently completed an end-to-end computational pipeline for the design of precision cancer immunotherapies, Ancer®. Under this collaboration, the companies will design and develop new personalized mRNA cancer vaccine candidates using GreenLight and EpiVax Therapeutics technology platforms. EpiVax Therapeutics has developed a proprietary computational tool for precision immunotherapy, Ancer®, an end-to-end, automated platform that integrates multiple advanced algorithms into a single pipeline to rapidly design custom therapies for individual cancer patients using each patient’s own tumor genome sequence as the starting point for the vaccine design. The Ancer® algorithms include two extensively validated tools, EpiMatrix® and JanusMatrix™, which, when used together, identify the most immunogenic CD8 and CD4 neoepitopes while excluding potentially tolerogenic epitopes that may reduce vaccine efficacy. EpiVax Therapeutics was the first personalized vaccine company to use computational tools to identify tolerogenic epitopes in neoantigens and to exclude these from cancer vaccine designs. EpiVax Therapeutics’ pipeline currently includes vaccine design capacity for bladder cancers and other solid tumors. GreenLight’s mRNA design, formulation and manufacturing expertise is currently applied to research and develop mRNA vaccine candidates, including a collaboration with the NIH to develop a next generation Covid vaccine, and a multi-target license agreement with Serum Institute of India, which includes developing a shingles vaccine candidate. GreenLight has also completed two commercial-scale engineering runs manufacturing mRNA at scale, in partnership with Samsung Biologics. This includes production of drug substance and lipid nanoparticle formulation to produce bulk drug product in a single facility, producing 650g of mRNA. Together, GreenLight and EpiVax Therapeutics will leverage their respective expertise and jointly develop and commercialize potential novel personalized mRNA-based vaccine candidates for a wide range of oncology indications. “We are delighted to partner with EpiVax Therapeutics, to expedite development of personalized cancer vaccine candidates using GreenLight’s RNA platform.” said Andrey Zarur, CEO of GreenLight. “We are excited to combine our mRNA design and manufacturing expertise with EpiVax Therapeutics’ neoantigen discovery platform and oncology expertise to build towards a future of accessible and timely oncology vaccines” EpiVax Therapeutics CEO, Nicole Ruggiero, added, “I am excited by what lies ahead. We have found the ideal partner for our personalized vaccine program in GreenLight Biosciences. Combining our advanced Ancer pipeline for personalized cancer vaccine design with GreenLight’s expertise in mRNA production is a win-win for the companies and for cancer patients.” About EpiVax Therapeutics: EpiVax Therapeutics, Inc. is a privately-held biotechnology company focusing on developing precision cancer immunotherapies. Incorporated in 2017, EpiVax Therapeutics spun-out of EpiVax Inc., a privately held immunoinformatics and vaccine design company founded by Dr. Annie De Groot and Mr. Bill Martin in 1998. EpiVax Therapeutics’ personalized vaccine design platform, Ancer®, incorporates the world-class EpiMatrix® system and the innovative JanusMatrix™ tool, which were exclusively licensed to EpiVax Therapeutics for use in Ancer, by EpiVax. The Ancer® platform is an end-to-end, biopsy-to-vaccine design platform that reduces the time required to develop personalized vaccines to hours rather than days while uncovering the most immunogenic neoantigens for precision cancer immunotherapy. More information about EpiVax Therapeutics is available at www.epivaxtx.com/ 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 messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company’s breakthrough cell-free RNA 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, including our latest investor presentation and other materials, please visit https://www.greenlightbiosciences.com/. Availability of Other Information About GreenLight Biosciences Investors and others should note that we communicate with our investors and the public using our website (www.greenlightbiosciences.com), the investor relations website (https://investors.greenlightbio.com/), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that GreenLight posts on these channels and websites could be deemed to be material information. As a result, GreenLight encourages investors, the media, and others interested in GreenLight to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on GreenLight’s investor relations website and may include additional social media channels. The contents of GreenLight’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the success, timing of and costs associated with the strategic collaboration, the success, cost and timing of our research and development activities in our plant and human health programs, 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, our projected cash runway and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in our Quarterly Reports on Form 10-Q, periodic filings on Form 8-K, and any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by current macroeconomic conditions and the ongoing COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. For additional information on GreenLight and potential risks associated with investing, please see our public filings at: https://investors.greenlightbio.com/financial-information/sec-filings. Contacts (GreenLight): Media Contact: Thomas Crampton SVP Corporate Affairs GreenLight Biosciences [email protected] Investor Contact: Ingrid Fung Director, Enterprise Operations and Strategy & Head of Investor Relations GreenLight Biosciences [email protected] Financial tables and further information, including regulatory filings, can be found on our website at https://investors.greenlightbio.com/ Contacts (Epivax Therapeutics): Guilhem Richard CTO, EpiVax Therapeutics, Inc. [email protected] Nicole Ruggiero CEO, EpiVax Therapeutics, Inc. [email protected] 9 January 2023 By Patrick 0 Comments
Investors, Press releases, Products GreenLight Biosciences Announces Third Quarter 2022 Financial Results and Highlights Recent Company Progress GreenLight Biosciences reported operational highlights and financial results for the third quarter ended September 30, 2022 Continue reading → 9 November 2022 By Patrick 0 Comments
Investors, Press releases, Products GreenLight Biosciences to Participate in Upcoming Investor Conferences in November GreenLight Biosciences today announced that Dr. Andrey Zarur, CEO, and Susan Keefe, CFO will participate in two upcoming investor conferences in November. Continue reading → 7 November 2022 By Patrick 0 Comments
Investors, Press releases GreenLight Biosciences announces realignment to focus on near-term value drivers BOSTON, MA, October 12, 2022—GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to bring effective and safe solutions to make food clean and affordable for everyone and dedicated to developing health solutions for every person on our planet, today announced a realignment to focus on key near-term value drivers and extend its cash runway. Key changes include further optimizing GreenLight’s organizational structure to better serve the company’s operations and more efficiently support the research, development and commercialization of its plant health and human health pipelines, primarily by integrating GreenLight’s platform team into the respective teams for human health and plant health. These integrations come with a staff reduction of approximately 25%. In recent months, GreenLight’s human health team announced manufacturing mRNA at scale with Samsung Biologics and launched partnerships to develop vaccines with the Vaccine Research Center at the National Institutes of Health and with Serum Institute of India. The plant health team has demonstrated first-of-a-kind field control of fungal pathogens such as Powdery Mildew, with effectiveness on a par with chemical standards. The team has also progressed work to develop RNA seed treatments, partnering with Germains Seed Technology. Field trials of GreenLight’s proprietary pollinator solution to protect honeybees showed control of varroa destructor mite similar or superior to a leading chemical alternative after 12 weeks. “Our goals, ambition and mission remain unchanged as we hone the focus of our work to current market conditions,” said Andrey Zarur, CEO of GreenLight. “The integration and streamlining of teams will help extend our runway and allow us to better focus on our near-term value drivers for human health and plant health.” For plant health, we continue to work on broadening the pipeline, which includes fungicides and insecticides. There will be particular emphasis on advancing registration and commercialization of the first-ever foliar-applied RNA for crop protection, Calantha™, GreenLight’s solution for control of the Colorado potato beetle. We will also continue towards regulatory submission of GreenLight’s solution targeting varroa mites, which are decimating honeybee colonies around the globe. For human health, our ongoing focus remains on obtaining proof of concept of GreenLight’s technology platform with our Covid vaccine and advancing our shingles program in collaboration with Serum Institute of India. Following on the Covid and Shingles work, GreenLight plans to continue to work on research programs addressing unmet medical needs in lower and middle income countries. As a result of this realignment, GreenLight will shift its focus from early-stage research programs—including our gene therapy program for sickle cell disease and our programs for antibody therapy and supra-seasonal flu—to opportunities that are nearer to commercialization. We are also reorganizing our operations in order to maximize the efficiency of our team, which we expect will reduce our facilities and other SG&A costs over time. The reductions in headcount are expected to generate savings of approximately $13 million in direct employee costs in 2023. In addition, we expect there will be savings from other direct and indirect cost areas. “This realignment comes following a range of cost cutting measures instituted earlier this year and will help us better position GreenLight for longer-term growth,” said Andrey Zarur, CEO of GreenLight. “For me, personally, it is heartbreaking to say goodbye to such incredibly talented and valued colleagues and we sincerely appreciate their dedication and contributions to GreenLight.” About GreenLight Biosciences GreenLight Biosciences (Nasdaq: GRNA) 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. Availability of Other Information About GreenLight Biosciences Investors and others should note that we communicate with our investors and the public using our website (www.greenlightbiosciences.com), the investor relations website (https://investors.greenlightbio.com/), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that GreenLight posts on these channels and websites could be deemed to be material information. As a result, GreenLight encourages investors, the media, and others interested in GreenLight to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on GreenLight’s investor relations website and may include additional social media channels. The contents of GreenLight’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the timing of and costs associated with our planned restructuring, and the benefits we expect to receive from the restructuring, the success, cost and timing of our research and development activities in our plant and human health programs, 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, our projected cash runway and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in our Quarterly Reports on Form 10-Q, periodic filings on Form 8-K, and any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the ongoing COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. For additional information on GreenLight and potential risks associated with investing, please see our public filings at https://investors.greenlightbio.com/financial-information/sec-filings Media Contact: Thomas Crampton SVP Corporate Affairs GreenLight Biosciences [email protected] Investor Contact: [email protected] https://investors.greenlightbio.com/ 12 October 2022 By Patrick 0 Comments
Investors, Press releases, Products GreenLight Biosciences and Queensland University of Technology partner to tackle destructive fall armyworm using RNA ● GreenLight Biosciences and Queensland University of Technology (QUT) partner to create a solution for fall armyworm ● Fall armyworm is one of the most destructive insect pests on the planet, causing more than US$2 billion in annual crop loss worldwide ● The Australian government has been searching for a more environmentally-friendly solution to fall armyworm and is supporting the partnership with a AUD$400,000 grant BOSTON, MA, and BRISBANE, Australia, October 5, 2022—Researchers from Boston’s GreenLight Biosciences and the Queensland University of Technology (QUT) in Brisbane, Australia, have announced an agreement to develop a solution to fall armyworm, which causes more than US$2 billion in annual global crop loss. The partnership includes an Australian government grant to QUT of more than AUD$400,000 from the Australian Research Council. It brings together the teams of two preeminent researchers, Dr. Julia Bally and Professor Peter Waterhouse from the QUT Centre for Agriculture and the Bioeconomy, and GreenLight’s Plant Health research and development team. The partnership aims to develop a solution for fall armyworm, a pest of national priority in Australia. It is also a point of emphasis that the project delivers environmentally-friendly crop protection tools against fall armyworm. GreenLight’s plant health division is working on producing RNA-based solutions for a variety of fungi and insects that cause massive food loss and crop damage annually. In lab tests and field trials, GreenLight’s RNA-based solutions leave low or no residues. Dr. Bally said previous collaboration on fall armyworm with GreenLight had been important to securing the grant from the Australian Research Council this year. “We are excited to work with GreenLight Biosciences on this solution to armyworm,” she said. “We believe furthering our partnership will generate comprehensive new technologies to fight against one of the most damaging global crop pests and greatly improve Australian agritech capacity and strengthen international collaborations.” GreenLight’s Vice President of Plant Health R&D Ron Flannagan said: “Fall armyworm has recently invaded Australia and devastates many crops, including sorghum and cotton. Our RNA platform allows us to develop solutions faster and more efficiently than was previously possible. So we are delighted to partner with QUT to accelerate our work targeting the fall armyworm with a sustainable solution.” The project will begin with lab studies and advance to greenhouse and field trials. “We believe this research will provide significant benefits, such as added security for Australia’s most important agricultural crops and regions and global food production,” Dr. Bally said. 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/ Press contact: David Pesci Head of Media Relations [email protected] For press, email: [email protected] For investors, email: [email protected] 5 October 2022 By Patrick 0 Comments
Blog, Investors GreenLight August investor presentation GreenLight highlights its vision and key developments. Download the full PDF below. 20220810-GLB_Impact-Deck_FinalDownload 15 August 2022 By Rob Blackie 0 Comments
Investors, Press releases GreenLight Biosciences Announces Second Quarter 2022 Financial Results and Highlights Recent Company Progress GreenLight raised $108.4 million in private placement led by S2G Ventures with strong participation from existing and new investors with cash expected to fund critical programs through the first half of 2023. GreenLight and Samsung Biologics completed their first commercial-scale engineering run for mRNA COVID-19 vaccine. Human health partnerships include NIH to support COVID-19 vaccine development against emerging variants and a platform licensing agreement with Serum Institute of India (SII) to develop a vaccine for shingles and up to two other targets. – Key milestones expected across plant health pipeline in 2022: anticipated EPA approval and launch of global-first foliar-applied RNA product Calantha™, a solution for Colorado potato beetle; regulatory submission for a solution to target varroa mites, which are destroying honeybee hives across the world; planning to register seven agricultural products by the end of 2026. BOSTON, August 15, 2022—GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to bring effective and safe solutions to make food clean and affordable for everyone and dedicated to developing health solutions for every person in our planet, today reported operational highlights and financial results for the second quarter ended June 30, 2022. “GreenLight’s RNA platform has continued to prove its value for developing a wide range of solutions to feeding the world and keeping it healthy. We founded GreenLight to change the world, and we have continued to make progress this quarter,” said Andrey Zarur, CEO of GreenLight. “Today, we are pleased to announce a capital infusion of $108.4 million. We are grateful for the support, continued faith, and trust of our longtime investors. We also welcome new investors who have decided to join GreenLight in our mission to help feed the world and keep it healthy. This will allow us to continue to make progress across our pipeline. “In recent months, we have demonstrated our ability to manufacture mRNA at a scale that produced material to provide the equivalent of millions of mRNA vaccine doses with Samsung Biologics. We have started animal studies on a shingles vaccine for our partnership with Serum Institute of India, the world’s biggest vaccine producer. We are working on COVID-19 vaccines with the National Institutes of Health that are more broadly protective against new variants and with longer-lasting effects. “In addition, we anticipate numerous plant health milestones in the coming months, including EPA approval and launch of Calantha™, our solution for Colorado potato beetles and regulatory submission for our solution targeting varroa mites, which are decimating honeybee colonies around the globe. We plan to register seven agricultural products by the end of 2026. We are undertaking field trials for several crop-protection solutions, with results available later this year. And our solutions are sustainable by design and produced in a responsible manner.” Second Quarter 2022 and Recent Operational Highlights: PLANT HEALTH PORTFOLIO: GreenLight is advancing double-stranded RNA (dsRNA) solutions for agricultural applications, including crop protection, designed to control pests and address resistance and residues of chemical alternatives, which affect food security and climate change. The company has seven agricultural products in active development, with an estimated total addressable market of $6 billion, that it plans to launch by 2026. Calantha: In 2022, GreenLight anticipates U.S. Environmental Protection Agency (EPA) approval of the company’s lead product, Calantha™, a foliar-applied dsRNA pesticide to protect against the Colorado potato beetle, a pest that has developed resistance to currently available chemical products. Pending approval, the company plans to launch commercially later this year. Honeybee Pollinator: GreenLight is actively conducting field trials for its topical RNA solution for varroa destructor mites, which decimate honeybee hives worldwide that pollinate more than 100 crops annually. In the second half of 2022, the company anticipates submitting a regulatory application to the EPA to support a planned 2024 launch, pending approval.Additional programs: The company is currently conducting confirmatory trials for Botrytis and Powdery Mildew programs, for which regulatory studies are expected to launch by the second half of 2023, and Fusarium, for which regulatory studies are expected to launch by the first half of 2024. The company also expects to launch greenhouse trials for its Diamondback Moth and broader Lepidoptera program in 2023. HUMAN HEALTH PORTFOLIO: COVID-19 Vaccine Program: The company’s COVID-19 vaccine candidate has shown a promising antibody response and cell-mediated immunity in mice, induced humoral responses exceeding standards set by the World Health Organization (WHO), and protected against morbidity in pre-clinical studies. GreenLight and IAVI, a non-profit scientific research organization, are pursuing a Phase I clinical trial, for which IAVI is responsible for clinical trial management in collaboration with its network of clinical research center partners. In July 2022, GreenLight announced a collaboration with the National Institutes of Health (NIH) to develop next-generation COVID-19 vaccines that are more broadly protective against new variants and with longer-lasting effects. GreenLight, in collaboration with the Vaccine Research Center (VRC), part of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), will co-design and test mRNA vaccines against coronaviruses with the goal of developing vaccines that confer a more durable immune response than current vaccines. The company expects to nominate a development candidate and initiate toxicology studies in 2H 2023.In August 2022, GreenLight and Samsung Biologics, a leading global contract development and manufacturing service provider, completed the first engineering run of their mRNA production partnership, which supports commercial-scale manufacturing of GreenLight’s mRNA COVID-19 vaccine candidate as well as future vaccine candidates. GreenLight’s mRNA synthesis reaction had a titer of 12g/L at a commercial scale and produced 650g of mRNA. All comparability data was in line with expected outcomes, indicating successful scale up and fit of GreenLight’s process to Samsung Biologics’ Songdo facility. The collaboration with Samsung leverages GreenLight’s existing manufacturing process, with technology transfer from GreenLight to Samsung having occurred in seven months, and accelerates GreenLight’s COVID-19 vaccine candidate at commercial scale.Our COVID-19 vaccine candidate, GLB-CoV-2-043, which is based on the original “Wuhan” strain of the COVID-19 virus has successfully completed preclinical testing and we are pursuing approval to begin clinical trials. In April of 2022, we applied for a Clinical Trials Application, or CTA, with the South African Health Products Regulatory Authority, or SAHPRA for a phase I/II single-vaccination booster study. That application was rejected with the recommendation that the resubmission include more detail on the specific benefits our testing efforts and a resulting vaccine will bring to South Africa considering the ready availability of other COVID-19 vaccines in that country. We plan on amending and resubmitting our CTA with that data in August and are also reviewing other countries in which to begin clinical trials and whether to do so in combination with a US-based Investigational New Drug, or IND, application with the FDA.Assuming regulatory clearance by October, the company continues to plan for initial data from this program in 2023. Following clinical proof-of-concept, GreenLight would seek a development partner to advance this program into pivotal studies. Additional programs: GreenLight is applying its mRNA platform technology to develop additional vaccine candidates that confer protection against prevalent infectious diseases and gene therapies for simple delivery of RNA-encoded instructions that carry out genomic edits in stem cells. Programs are focused on diseases prevalent in underserved and emerging markets, particularly in lower- and middle-income countries, and are currently in research and early preclinical stages of development. In March 2022, GreenLight and Serum Institute, the world’s largest vaccine manufacturer by number of doses produced and sold, announced a multi-target licensing agreement aimed at accelerating accessibility to mRNA products in emerging markets globally. The agreement grants Serum Institute rights to develop, manufacture, and commercialize a low-cost, easily stored mRNA vaccine for shingles, and an option to pursue two additional vaccine or therapeutic targets, in Africa, Latin America, the Middle East, and Asia, excluding China, Japan, and South Korea. In exchange, GreenLight is responsible for the discovery and design of vaccine candidates and received an upfront payment as well as eligibility for potential downstream development milestones and royalties on any commercial sales deriving from this agreement, while retaining rights in other regions. The companies expect to nominate a development candidate for shingles in 1H 2023.GreenLight is pausing its gene therapy program, in development for sickle cell anemia, due to prioritization of its advanced-stage portfolio amid budget considerations. Research for this program was initially conducted with support from the Bill & Melinda Gates Foundation. Corporate Updates: Today, the company announced approximately $109 million in private placement fundraise led by S2G Ventures with strong participation from existing and new investors, with cash expected to fund critical programs through the first half of 2023. Investors also include BNP Paribas Ecosystem Restoration Fund, Continental Grain Company, Cormorant Asset Management, the Cummings Foundation, Fall Line Capital, the FTX Foundation, Insud Pharma, Morningside Venture Investments, Rivas Capital, Sigmas Group, SymBiosis and certain directors and executive officers of GreenLight.In March 2022, Barney Graham, MD, PhD., joined GreenLight’s Human Health Scientific Advisory Board. Dr. Graham was the former deputy director of the NIAID Vaccine Research Center, with an extensive background in basic and translational research applied to vaccine development. He is best known for his research on respiratory syncytial virus (RSV), influenza, coronaviruses, HIV, and other emerging viral diseases. Second Quarter 2022 Financial Results Cash Position: Cash, cash equivalents, and marketable securities were $44.1 million as of June 30, 2022, compared to $31.4 million as of December 31, 2021. The increase was primarily driven by proceeds received from the close of the business combination and concurrent PIPE financing. This increase was offset in part by cash used to fund operations of approximately $72.2 million.Collaboration Revenue: Collaboration revenue increased to $1.7 million during the second quarter of 2022, compared to $0 during the second quarter of 2021. This revenue was primarily related to the delivery of research services, which includes manufacturing technology transfer services, in connection with the March 2022 collaboration agreement with Serum Institute.R&D Expenses: Research and development expenses increased by $22.1 million to $44.2 million during the second quarter of 2022, compared to $22.0 million during the second quarter of 2021. This increase was primarily related to increased program costs related to pre-clinical trial activities and personnel expenses, as well as facilities costs such as rent and depreciation expenses. Included in the R&D expense in Q2 2022 was approximately $15.0 million in costs related to materials purchased and fees for the manufacturing scale up at Samsung Biologics.G&A Expenses: General and administrative expenses increased by $4.7 million to $9.6 million during the second quarter of 2022, compared to $4.9 million during the second quarter of 2021. This increase was primarily related to an increased level of support required for the growth of the company’s programs and pipelines and public company requirements.Net Loss: The company’s net loss was $51.9 million for the second quarter of 2022, compared to $27.2 million during the second quarter of 2021. Financial Guidance: The company expects its cash and equivalents of $44.1 million as of June 30, 2022, taken together with $108.4 million in proceeds from the PIPE financing announced today, will be sufficient to fund planned operating expenses and capital expenditures, through the first half of 2023. The company will continue to evaluate a range of opportunities to extend cash runway, including management of program spending, platform licensing collaborations, and potential financing activities. 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 messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company’s breakthrough cell-free RNA 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, including our latest investor presentation and other materials, please visit https://www.greenlightbiosciences.com/. Forward-Looking Statements: This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to GreenLight’s future finances, operations, or scientific developments. 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 this document, including failure to receive regulatory approval, the evolution of the Covid-19 pandemic and therapies to address that pandemic, our ability to raise and productively deploy capital and the rate at which we can successfully bring products to market. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to, risks and uncertainties detailed from time to time in the Company’s reports that it files with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2021, filed on March 31, 2022 with the SEC, as well as its Quarterly Reports on Form 10-Q and periodic filings on Form 8-K. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law. For additional information on GreenLight and potential risks associated with investing, please see our public filings at https://www.sec.gov/edgar/browse/?CIK=1822691&owner=exclude. Condensed consolidated statements of operations (unaudited) and condensed consolidated balance sheets (unaudited) can be found on our investor website here:https://investors.greenlightbio.com/ 15 August 2022 By Rob Blackie 0 Comments
Investors, Press releases GreenLight Biosciences announces $109 million financing GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to bring effective and safe solutions to make food clean and affordable for everyone and dedicated to developing health solutions for every person on our planet Continue reading → 12 August 2022 By Patrick 0 Comments