MUT

- Pre-clinical results published in PLOS ONE demonstrating a single intravenous administration of mLB-001 in neonatal or adult MMA mice correlated with prevention of severe weight loss and mortality when challenged with a high protein diet - Definitive merger agreement with Alexion, AstraZeneca Rare Disease, to acquire LogicBio with transaction LEXINGTON, Mass., Nov. 14, 2022 /PRNewswire/ -- LogicBio® Therapeutics, Inc. (NASDAQ: LOGC), a clinical-stage genetic medicine company, today reported financial results for the third quarter ended September 30, 2022 and provided business updates. Recent Business Highlights: In August, LogicBio presented interim data from the SUNRISE Phase 1/2 trial evaluating LB-001 in pediatric patients with severe methylmalonic acidemia (MMA). Interim data in four pediatric patients showed detectable levels of albumin 2-A (ALB-2A), a technology-related biomarker, in serum. Detection of ALB-2A in the serum indicates MMUT gene integration and MUT protein expression. Increasing levels of ALB-2A suggest the expansion of the edited cells over time. In two of the four patients, increasing levels of albumin 2-A (ALB-2A) were seen over time, indicating selective advantage. Selective advantage enables edited hepatocytes carrying the corrective gene to survive and reproduce better than the endogenous mutated hepatocytes and to ultimately repopulate a part or whole of the diseased liver. In September, results from a LogicBio mLB-001 pre-clinical study were published in the peer-reviewed journal PLOS ONE. The results demonstrated that a single intravenous administration of mLB-001 in neonatal or adult MMA mice correlated with prevention of severe weight loss and mortality when challenged with a high protein diet. As previously announced in October, the Company announced it entered into a definitive merger agreement with Alexion, AstraZeneca Rare Disease to acquire LogicBio Therapeutics for $2.07 per share. The transaction was unanimously approved by both boards of directors. Alexion plans to close the deal in four to six weeks, subject to the tender of at least a majority of the outstanding shares of LogicBio common stock and satisfaction of other closing conditions. Third Quarter 2022 Financial Results: Three Months Ended September 30, 2022, and 2021 Revenue: Revenue for the quarter ended September 30, 2022, consisted of $2.7 million in collaboration and service revenue recognized under our April 2021 agreements with CANbridge Care Pharma Hong Kong Limited (CANbridge) and Daiichi Sankyo Company, Limited (Daiichi Sankyo). Revenue for the quarter ended September 30, 2021, consisted of $2.1 million in collaboration and service revenue related to our arrangements with CANbridge, Daiichi, and our agreement with Takeda Pharmaceutical Company Limited (Takeda). R&D Expenses: Research and development expenses for the quarter ended September 30, 2022, were $5.1 million, compared to $7.8 million for the quarter ended September 30, 2021. The decrease of approximately $2.8 million was primarily due to a decrease of $1.7 million in LB-001 external development and manufacturing costs incurred during third quarter 2021 related to the LB-001 SUNRISE clinical trial, a $0.6 million decrease in lab supplies due to a decrease in headcount and a $0.5 million decrease in other research and development costs related to work completing under the Children's Medical Research Institute agreement. G&A Expenses: General and administrative expenses were $3.4 million for the quarter ended September 30, 2022, compared to $4.3 million for the quarter ended September 30, 2021. The decrease of approximately $0.8 million was primarily driven by a decrease of approximately $0.3 million in professional service fees as we brought more professional capabilities in-house and a decrease of $0.3 million in personnel expenses as headcount decreased. Net Loss: Net loss for the quarter ended September 30, 2022, was $5.8 million or $0.18 per share, compared to a net loss of $10.2 million for the quarter ended June 30, 2021, or $0.31 per share. Cash Position: As of September 30, 2022, we had cash and cash equivalents of $30.8 million as compared to $53.5 million as of December 31, 2021. As of September 30, 2022, we had 32,962,733 shares outstanding. About LogicBio Therapeutics LogicBio® Therapeutics is a clinical-stage genetic medicine company pioneering genome editing and gene delivery platforms to address rare and serious diseases from infancy through adulthood. The company's genome editing platform, GeneRide®, is a new approach to precise gene insertion harnessing a cell's natural DNA repair process potentially leading to durable therapeutic protein expression levels. The company's gene delivery platform, sAAVy™, is an adeno-associated virus (AAV) capsid engineering platform designed to optimize gene delivery for treatments in a broad range of indications and tissues. The company's proprietary manufacturing process, mAAVRx™, aims to overcome one of the current limitations of AAV manufacturing by improving yields and product quality. The company is based in Lexington, MA. For more information, visit , which does not form a part of this release. About LB-001 LB-001 is an investigational, first-in-class, single-administration, genome editing therapy for early intervention in methylmalonic acidemia (MMA) using LogicBio®'s proprietary GeneRide® drug development platform. GeneRide technology utilizes a natural DNA repair process called homologous recombination designed to enable precise editing of the genome without the need for exogenous nucleases and promoters that have been associated with an increased risk of immune response and cancer. LB-001 is designed to non-disruptively insert a corrective copy of the methylmalonyl-CoA mutase (MMUT) gene into the albumin locus to drive lifelong therapeutic levels of MMUT expression in the liver, the main site of MMUT expression and activity. LB-001 is delivered to hepatocytes intravenously via liver-targeted, engineered recombinant adeno-associated virus vector (rAAV-LK03). Preclinical studies found that LB-001 was safe and demonstrated transduction of hepatocytes, site-specific genomic integration, and transgene expression. LB-001–corrected hepatocytes in a mouse model of MMA demonstrated preferential survival and expansion (selective advantage), thus contributing to a progressive increase in hepatic MMUT expression over time. LB-001 resulted in improved growth, metabolic stability, and survival in MMA mice. The U.S. Food and Drug Administration (FDA) granted fast track designation, rare pediatric disease designation and orphan drug designation for LB-001 for the treatment of MMA. In addition, the European Medicines Agency (EMA) granted orphan drug designation for LB-001 for the treatment of MMA. Forward-Looking Statements Statements in this press release regarding LogicBio®'s strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to statements regarding the potential of the GeneRide® platform and the closing of the proposed merger with Alexion. The terms "believe," "look forward," "future," "intend," "designed," "potential," "suggests," "plans," "expects" and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that existing preclinical and/or clinical data may not be predictive of the results of ongoing or later preclinical and/or clinical results; the risk that we may not be successful in efforts to leverage our technologies for business development or otherwise; risks associated with management and key personnel changes and transitional periods; the actual funding required to develop and commercialize product candidates, including for safety, tolerability, enrollment, manufacturing or economic reasons; the timing and content of decisions made by regulatory authorities; the actual time it takes to initiate and complete preclinical and clinical studies, including the actual time it takes to demonstrate clinical efficacy; the competitive landscape; changes in the economic and financial conditions of LogicBio; and our ability to consummate the proposed merger with Alexion, including our ability to satisfy the conditions to the proposed merger. Other risks and uncertainties include those identified under the heading "Risk Factors" in LogicBio's Annual Report on Form 10-K for the year ended December 31, 2021 and other filings that LogicBio may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and LogicBio does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release. Investor Contact: Stephen Jasper Gilmartin Group (858) 525-2047 [email protected] Media Contacts: Adam Daley Berry & Company Public Relations W:212-253-8881 C: 614-580-2048 [email protected] SOURCE LogicBio Therapeutics, Inc.

Single intravenous administration of mLB-001 in neonatal or adult MMA mice correlated with prevention of severe weight loss and mortality when challenged with a high protein diet. LEXINGTON, Mass., Sept. 21, 2022 /PRNewswire/ -- LogicBio Therapeutics, Inc. ( Nasdaq: LOGC), a clinical-stage genetic medicine company, today announced that results from the company's preclinical research study entitled "Novel AAV-mediated genome editing therapy prevents metabolic decompensation in a mouse model of methylmalonic acidemia" have been published in the peer-reviewed journal PLOS ONE. MMA is a metabolic disorder most commonly caused by mutations in the methylmalonyl-CoA mutase (MMUT) gene. Patients with MMUT deficiency are currently treated with strict life-long dietary management to mitigate acute illness that worsens the patient's basal condition, particularly with respect to metabolic brain injury. Early-stage research has indicated that restoration of Mmut enzymatic activity by gene addition mediated by recombinant adeno-associated virus (rAAV) could be a promising approach in the treatment of MMUT deficiency in pediatric patients. In the study, researchers developed a novel protein-controlled diet regimen in a MMUT deficient mouse model of MMA that mimics the metabolic crises that MMA patients experience. Mice were treated with a single administration of mLB-001, a nuclease-free, promoterless recombinant AAV vector designed based on LogicBio's proprietary GeneRide® platform to deliver the mouse MMUT into the endogenous albumin locus. Mice deficient in MMUT that were treated with the Generide AAV vector had attenuated body weight loss and were protected from mortality when challenged with a high protein diet. GeneRide-edited hepatocytes also expressed functional MMUT protein and expanded over time in the MMUT deficient mice, suggesting a selective growth advantage over the diseased cells. The expansion of the edited cells was detected over time in the MMA mice by measuring increasing levels of Alb-2A, the same technology-specific biomarker that is being used in LogicBio's SUNRISE trial, a first-in-human, open-label, multi-center, Phase 1/2 clinical trial designed to assess the safety, tolerability, and preliminary efficacy of a single intravenous infusion of LB-001 in pediatric patients with MMA. "There are no approved therapies to treat the underlying cause of MMUT deficiency. Currently, pediatric patients are managed with strict life-long dietary restrictions designed to help mitigate acute illness that worsens the patient's basal condition, particularly with respect to metabolic brain injury," said Mariana Nacht, chief scientific officer at LogicBio. "These new preclinical results provide strong additional support for the continued development of LB-001 in this indication with the potential to deliver significant benefits to pediatric patients." To access the full article, click here. About LogicBio® Therapeutics LogicBio® Therapeutics is a clinical-stage genetic medicine company pioneering genome editing and gene delivery platforms to address rare and serious diseases from infancy through adulthood. The company's genome editing platform, GeneRide®, is a new approach to precise gene insertion harnessing a cell's natural DNA repair process potentially leading to durable therapeutic protein expression levels. The company's gene delivery platform, sAAVy™, is an adeno-associated virus (AAV) capsid engineering platform designed to optimize gene delivery for treatments in a broad range of indications and tissues. The company's proprietary system, mAAVRx™, aims to overcome some of the current limitations of AAV manufacturing by optimizing the transfection process to improve yields and product quality. The company is based in Lexington, MA. For more information, visit , which does not form a part of this release. Forward-Looking Statements Statements in this press release regarding LogicBio®'s plans, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to statements regarding whether certain approaches could be promising in the treatment of MMUT deficiency in pediatric patients; and the potential of the GeneRide® platform. The terms "aim," "anticipate," "designed," "enables," "evaluate," "expects to," "look forward to," "will," and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that existing preclinical data may not be predictive of the results of ongoing or later preclinical and/or clinical results; the risk that the potential direct or indirect impact of the COVID-19 pandemic on our business, operations, and the markets and communities in which we and our partners, collaborators and vendors operate; manufacturing risks; risks associated with management and key personnel changes and transitional periods; the actual funding required to develop and commercialize product candidates, including for safety, tolerability, enrollment, manufacturing or economic reasons; the timing and content of decisions made by regulatory authorities; the actual time it takes to initiate and complete clinical studies; the competitive landscape; changes in the economic and financial conditions of LogicBio; and LogicBio's ability to obtain, maintain and enforce patent and other intellectual property protection for LB-001 and any other product candidates. Other risks and uncertainties include those identified under the heading "Risk Factors" in LogicBio's Annual Report on Form 10-K for the year ended December 31, 2021 and other filings that LogicBio may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and LogicBio does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release. Investor Contacts: Stephen Jasper Gilmartin Group 858-525-2047 [email protected] Media Contacts: Adam Daley Berry & Company Public Relations 212-253-8881 [email protected] SOURCE LogicBio Therapeutics, Inc.

Interim data from Phase 1/2 propionic acidemia (PA) multi-dose Paramount trial shows mRNA-3927 was well-tolerated to date, with encouraging early signs of potential for clinical benefit Interim data from Phase 1/2 glycogen storage disease 1a (GSD1a) single-dose Ba1ance trial shows mRNA-3745 was well tolerated to date, with encouraging early signs of potential for clinical benefit Moderna announces a new development candidate, mRNA-3139, for ornithine transcarbamylase (OTC) deficiency, a rare genetic disorder Phase 3 clinical trial of RSV vaccine, mRNA-1345, has enrolled more than 24,000 of the 34,000-participant target Phase 3 immunogenicity and safety study of flu vaccine, mRNA-1010, is fully enrolled; Company to pursue accelerated approval pathway in 2023 Company is on track to report data from its Phase 2 personalized cancer vaccine (PCV) study in 4Q 2022 CAMBRIDGE, MA / ACCESSWIRE / September 8, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced advances across its portfolio of mRNA programs presented at the Company's annual R&D Day. "We continue to make significant progress in accelerating our pipeline. Our Phase 3 flu and RSV clinical trials are rapidly advancing toward completion. We are seeing early clinical benefits in two rare disease programs and we expect to report on data from our personalized cancer vaccine trial later this year," said Stéphane Bancel, Chief Executive Officer of Moderna. "As a reflection of the Company's growth and progress, we are preparing for multiple product launches globally." Updates and recent progress include: mRNA Therapeutics Rare Diseases: Proof-of-Concept Studies Propionic Acidemia: Propionic acidemia (PA) is a rare and severe metabolic disorder. PA is characterized by a deficiency of propionyl-CoA carboxylase, an enzyme involved in the breakdown of proteins, certain fatty acids, and other substances. This deficiency leads to the build-up of toxic compounds that can cause serious health problems like repeating episodes of life-threatening metabolic crises and damage to the brain, nervous system, and heart. There is no approved pharmacologic therapy for PA. Moderna's mRNA therapy for PA, mRNA-3927, encodes for two proteins that can help the body make the missing enzyme that is absent in PA patients. The Phase 1/2 Paramount clinical trial, evaluating the safety and pharmacology of mRNA-3927, is actively enrolling PA patients. Several critical milestones have been reached in the trial. Over 120 repeated intravenous doses have been administered to 10 patients. So far, mRNA-3927 is well-tolerated at the doses tested. To date, there has been no dose-limiting toxicity, discontinuations due to safety, or drug-related serious adverse safety events. Three of the ten study participants have been dosed with over one year of continuous treatment. All eligible participants have decided to continue with treatment by participating in the Open Label Extension Study. PA is characterized by recurrent life-threatening metabolic decompensation events (MDEs) which are clinical crises that occur when there is a build-up of toxic metabolites. Due to the objective and disease-defining nature of MDEs, regulators have provided initial support for MDE as a clinically meaningful, preferred primary clinical endpoint for development. Based on preliminary data, there was a decrease in the number of MDEs post-mRNA-3927 treatment. The trial will continue with testing the next dose level (0.6 mg/kg IV every two weeks). Glycogen Storage Disease 1a: Glycogen Storage Disease 1a (GSD1a) is a rare, inherited metabolic disorder. GSD1a is caused by a deficiency of an enzyme called glucose 6-phosphatase (G6Pase-α). G6Pase-α is critical for the release of glucose in the blood, and is needed to maintain normal blood sugar levels. Patients with GSD1a may have life-threatening events when their blood sugar levels are too low. They may also experience long-term liver complications, possibly including cancer. There are no approved pharmacologic therapies for GSD1a. Young children with GSD1a require tube feeding at night and life-long regular blood glucose monitoring with strict adherence to a special diet of frequent feedings (every 4-6 hours) and uncooked or modified cornstarch. Taking care of GSD1a patients places a significant burden on family members. Participants have been dosed in Moderna's Phase 1/2 Ba1ance trial that is evaluating a GSD1a therapeutic candidate, mRNA-3745. This study is the first to evaluate the safety, tolerability, and pharmacology of a single intravenous dose of mRNA-3745 in adult participants with GSD1a. Early data on safety and pharmacodynamics are consistent and encouraging. In two patients, intravenous infusion of mRNA-3745 was well tolerated to date, and showed extension of fast duration and normalization of glucose during fast. Enrollment and safety evaluations are continuing, with initial data expected in 2023. Methylmalonic acidemia: PA and methylmalonic acidemia (MMA) share similar biology and disease pathology (deficiency of an enzyme in the propionate pathway) with subsequent accumulation of toxic metabolites. MMA is a rare genetic disease with significant morbidity and mortality caused by a deficiency in an enzyme called methylmalonyl-CoA mutase (MUT). MMA mostly affects children, and there is no approved pharmacologic therapy. Long-term complications of MMA can include problems with neurocognitive function, slower growth, and heart, kidney, and blood problems. The first two groups of patients are fully enrolled in Moderna's Landmark Study, a Phase 1/2 clinical trial to evaluate the safety and pharmacology of mRNA-3705 for MMA. mRNA-3705 is designed to instruct the body to restore the missing or dysfunctional proteins that cause MMA. Moderna is recruiting participants in the United Kingdom, Canada, and the U.S. Initial data from the trial are expected by 2023. Rare Disease: New Development Candidate Leveraging data and learnings from the rare disease program, Moderna announces a new development candidate, mRNA-3139, for ornithine transcarbamylase (OTC) deficiency. mRNA-3139 uses the same lipid nanoparticles (LNP) as in Moderna's GSD1a program and is the Company's sixth rare disease candidate. OTC deficiency is a rare genetic condition characterized by complete or partial lack of the OTC enzyme, resulting in ammonia build-up in the blood. The clinical presentation of OTC deficiency is very heterogeneous, with more severe symptoms including seizures, enlarged liver, and respiratory difficulty. For more severe or non-responsive cases that progress towards liver failure, treatment may include liver transplantation. Late-Stage Respiratory Vaccines COVID-19 Boosters Moderna has launched two vaccine boosters to meet different needs across the largest markets: mRNA-1273.214 and mRNA-1273.222. mRNA-1273.214 is a COVID-19 bivalent booster vaccine that targets both the original strain of SARS-CoV-2 and the Omicron variant of concern (BA.1). Clinical trials demonstrated that this booster vaccine increased the immune response against the more recent Omicron strains (BA.4 and BA.5). They found the results to be similar regardless of prior infection status or age. Moderna developed mRNA-1273.222 in accordance with guidance from the U.S. FDA to develop a booster vaccine targeting the Omicron BA.4 and BA.5 variants, combined with mRNA-1273. A Phase 2/3 clinical trial for mRNA-1273.222 is currently underway and fully enrolled. Moderna has rapidly scaled manufacturing of COVID-19 boosters and began delivery of doses in August. Seasonal Influenza Vaccine Program: Influenza, which occurs seasonally, causes respiratory illnesses and places a substantial burden on healthcare systems. Worldwide, the influenza virus leads to 3-5 million cases of severe illness and 290,000-650,000 influenza-related respiratory deaths annually. About 8% of the US population experiences symptoms from influenza each year, with 140,000-710,000 hospitalizations and 12,000-52,000 deaths per year. mRNA-1010 is a vaccine candidate that encodes for hemagglutinin (HA) glycoproteins of the four influenza strains recommended by the World Health Organization (WHO) for the prevention of influenza. HA is a major influenza surface glycoprotein that is considered an important target to generate broad protection against influenza and is the primary target of currently available influenza vaccines. A Phase 3 immunogenicity and safety study of mRNA-1010 in the Southern Hemisphere is fully enrolled (~6,000 participants). Initial regulatory feedback supports an accelerated pathway for approval. Moderna is also preparing to launch a Phase 3 efficacy trial in the Northern Hemisphere to demonstrate superior effectiveness of mRNA-1010 against a currently licensed seasonal influenza vaccine. Respiratory Syncytial Virus Vaccine Program: Respiratory syncytial virus (RSV) causes a substantial disease burden in older adults aged 65 years and older. There are approximately 177,000 RSV-related hospitalizations in adults 65 and older in the U.S. each year and approximately 14,000 RSV-related deaths. Globally, there are more than 1.5 million episodes of acute respiratory tract infection related to RSV each year. Moderna's pivotal Phase 3 placebo-controlled clinical trial of mRNA-1345, an RSV vaccine, will evaluate its effectiveness in older adults (adults 60 years of age and older); so far, the trial has enrolled more than 24,000 of the anticipated 34,000 participants. The study has been designed to provide an efficacy readout in the 2022-2023 winter season. Since RSV also causes a significant disease burden in children, mRNA-1345 is being tested in an ongoing Phase 1 trial in pediatric populations. Combination Respiratory Vaccines In addition to single-agent vaccines, the Company is progressing several combination respiratory vaccines, including a fully enrolled Phase 1/2 trial testing mRNA-1073 targeting SARS-CoV-2 and influenza. Clinical trials for mRNA-1230, targeting SARS-CoV-2, influenza, and RSV are expected to be initiated this year. Late-Stage Latent Vaccine: CMV Trials Cytomegalovirus Vaccine Program: Cytomegalovirus (CMV), a type of latent herpes virus, is the most common cause of infection that occurs before birth worldwide and is responsible for more than $1 billion in annual healthcare costs. CMV can cause long-term health problems in infected infants, such as hearing loss, vision impairment, cerebral palsy, learning disabilities, and decreased muscle strength and coordination. Moderna's CMV vaccine candidate, mRNA-1647, comprises six mRNAs encoding two antigens in one vaccine and is designed to protect against CMV infection. mRNA-1647 is being evaluated in the Phase 3 CMVictory trial to prevent congenital CMV. To date, more than 40% of anticipated participants are enrolled. The study will determine the efficacy, safety, and immunogenicity of mRNA-1647 against CMV infection in women ages 16-40 years. Enrollment is ongoing in the U.S. and internationally. In addition to congenital infection, CMV has a major impact on morbidity and mortality in transplant patients. CMV is a frequent complication after transplantation since the ability to fight infection after transplant is decreased. Moderna is planning to test mRNA-1647 in a randomized, placebo-controlled, study to evaluate the efficacy, safety, and immunogenicity of mRNA-1647 in patients who have undergone a high-risk stem cell transplant. Personalized Cancer Vaccine Personalized cancer vaccines (PCV) target an individual patient's unique tumor mutations to selectively treat their cancer. Moderna's PCV program is being developed in collaboration with Merck. mRNA-4157 is a PCV candidate designed to stimulate an immune response by boosting T cells, which are believed to be necessary for a curative cancer therapy. Moderna's Phase 2 clinical trial will determine if mRNA-4157 in combination with KEYTRUDA®, an approved cancer therapy, can improve recurrence-free survival (at 12 months) in patients with resected melanoma at high risk of recurrence, compared to KEYTRUDA alone. KEYTRUDA was selected as the comparator in the trial because it is considered the standard of care for high-risk melanoma patients. The Phase 2 trial is fully enrolled and primary data are expected in 4Q 2022. Commercial Preparation As Moderna's pipeline advances, preparations are underway for multiple vaccine launches globally between 2023-2026. Commercial priorities include planning for the 2023 endemic COVID-19 market, expanding into respiratory vaccine markets with single-agent and combination vaccines for RSV, influenza, and COVID-19, preparing for a possible CMV vaccine launch, and entering the therapeutics market. Moderna to pursue accelerated pathway for potential approval of the flu vaccine (mRNA-1010) in 2023. Moderna continues to invest in building global manufacturing capabilities to support multiple product launches, including seasonal updates and different product formulations. About Moderna In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic. Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: clinical trends in Moderna's Phase 1/2 PA trial; Moderna's pursuit of an accelerated approval pathway for mRNA-1010 and the timing of potential approval; the timing of data from Moderna's trials of its product candidates targeting PCV, MMA,GSD1a and RSV; the initiation of clinical trials for mRNA-1230, targeting SARS-CoV-2, influenza and RSV; Moderna's commercial priorities; the timing of future product launches; Moderna's manufacturing capabilities; and the timing of delivery of COVID-19 boosters. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, each filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at . Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. Moderna Contacts Media: Mary Beth Woodin Senior Director, R&D Communications 617-899-3991 MaryBeth.Woodin@modernatx.com Investors: Lavina Talukdar Senior Vice President& Head of Investor Relations 617-209-5834 Lavina.Talukdar@modernatx.com SOURCE: Moderna,Inc. View source version on accesswire.com: