The Conversation (0)
- 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.
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) | THREE MONTHS ENDED JUNE 30, | SIX MONTHS ENDED JUNE 30, | |||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| REVENUE: | |||||||||||||||
| License and collaboration revenue | $ | 1,748 | $ | — | $ | 1,748 | $ | — | |||||||
| Grant revenue | 20 | 493 | 277 | 818 | |||||||||||
| Total revenue | 1,768 | 493 | 2,025 | 818 | |||||||||||
| OPERATING EXPENSES: | |||||||||||||||
| Research and development | 44,151 | 22,009 | 71,432 | 39,420 | |||||||||||
| General and administrative | 9,577 | 4,933 | 19,332 | 8,831 | |||||||||||
| Total operating expenses | 53,728 | 26,942 | 90,764 | 48,251 | |||||||||||
| LOSS FROM OPERATIONS | (51,960 | ) | (26,449 | ) | (88,739 | ) | (47,433 | ) | |||||||
| OTHER INCOME (EXPENSE) | |||||||||||||||
| Interest income | 57 | 5 | 61 | 16 | |||||||||||
| Interest and other expense | (1,338 | ) | (529 | ) | (2,411 | ) | (840 | ) | |||||||
| Change in fair value of warrant liabilities | 1,315 | (201 | ) | 956 | (200 | ) | |||||||||
| Total other income (expense), net | 34 | (725 | ) | (1,394 | ) | (1,024 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (51,926 | ) | $ | (27,174 | ) | $ | (90,133 | ) | $ | (48,457 | ) | |||
| Net loss per share available to common stockholders—basic and diluted | $ | (0.42 | ) | $ | (0.28 | ) | $ | (0.76 | ) | $ | (0.50 | ) | |||
| Weighted-average common stock outstanding—basic and diluted | 123,249,757 | 96,327,956 | 118,430,851 | 96,314,179 | |||||||||||
| Condensed Consolidated Balance Sheets (unaudited) | JUNE 30, 2022 | DECEMBER 31, 2021 | ||||
| Cash and cash equivalents | $ | 44,132 | $ | 31,446 | ||
| Accounts receivable | 10,000 | — | ||||
| Prepaid expenses | 9,870 | 2,331 | ||||
| Restricted cash | 1,321 | 362 | ||||
| Property and equipment, net | 32,085 | 23,399 | ||||
| Deferred offering costs | — | 4,099 | ||||
| Other assets | 1,402 | 1,420 | ||||
| TOTAL ASSETS | $ | 98,810 | $ | 63,058 | ||
| Accounts payable | $ | 4,155 | $ | 7,551 | ||
| Accrued expenses | 30,427 | 14,624 | ||||
| Convertible debt | — | 31,691 | ||||
| Long-term debt, current portion | 11,402 | 7,234 | ||||
| Deferred revenue, current portion | 8,939 | 963 | ||||
| Other current liabilities | 294 | 278 | ||||
| Warrant liabilities | 470 | 2,105 | ||||
| Long-term debt, net of current portion | 20,156 | 27,152 | ||||
| Other liabilities | 9,242 | 1,435 | ||||
| TOTAL LIABILITIES | 85,085 | 93,033 | ||||
| TOTAL STOCKHOLDERS' EQUITY (DEFICIT) | 13,725 | (29,975 | ) | |||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 98,810 | $ | 63,058 | ||
Media contact:
David Pesci
Head of Media Relations
GreenLight Biosciences
dpesci@greenlightbio.com
press@greenlightbio.com
Investor contact:
investors@greenlightbio.com
https://investors.greenlightbio.com/
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9468029c-b0f1-4fb2-8322-945e6e886e15
Figure one: Individual patient (001-005) and pooled results highlighting improvements in fibromyalgia domains as presented by University of Michigan 9 August 2024 (adapted)
Figure two: Individual patient and pooled results as presented by University of Michigan 9 August 2024 (adapted)