MRNA Moderna Inc.

125.14
+0.13  (+0%)
Previous Close 125.01
Open 124.51
52 Week Low 17.91
52 Week High 178.5
Market Cap $49,519,162,540
Shares 395,710,105
Float 304,028,822
Enterprise Value $46,403,712,226
Volume 7,986,134
Av. Daily Volume 26,244,579
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Drug Pipeline

Drug Stage Notes
mRNA-1273
COVID-19 vaccine
Approved
Approved
FDA approval (EUA) announced December 18, 2020.
mRNA-1944
Chikungunya Virus Infection
Phase 1
Phase 1
Phase 1 data presented September 2020.
VEGF-A(AZD8601)
Heart Failure
Phase 2a
Phase 2a
Phase 2a trial ongoing.
mRNA-2752
Solid tumors, lymphoma
Phase 1
Phase 1
Phase 1 trial is ongoing.
mRNA-5671
KRAS cancer vaccine
Phase 1
Phase 1
Phase 1 trial is ongoing.
mRNA-4157 (KEYNOTE-942)
Personalized cancer vaccine
Phase 1
Phase 1
Phase 2 trial is ongoing.
mRNA-1653
Human Metapneumovirus and Human Parainfluenza Infection (hMPV+PIV3 vaccine)
Phase 1
Phase 1
Phase 1 trial is ongoing.
HIV vaccine (mRNA-1644 & mRNA-1574)
HIV
Phase 1
Phase 1
Phase 1 trials to commence 2021.
Flu vaccine (mRNA-1010, mRNA-1020, mRNA-1030)
Flu vaccine
Phase 1
Phase 1
Phase 1 trials to commence 2021.
mRNA-3704
Methylmalonic Acidemia (MMA)
Phase 1/2
Phase 1/2
Phase 1/2 enrollment paused due to COVID-19.
mRNA-1647
CMV vaccine (Cytomegalovirus Infection)
Phase 2
Phase 2
Phase 2 first interim analysis announced September 17, 2020. Phase 3 trial to commence in 2021.
mRNA-1345
Respiratory syncytial virus (RSV) vaccine
Phase 1
Phase 1
Phase 1 initiation announced October 8, 2020.
mRNA-2416 and durvalumab
Ovarian cancer
Phase 1/2
Phase 1/2
Phase 2 dosing has commenced - noted September 17, 2020.

Latest News

  1. Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that José M. Vega, M.D. joined Moderna as Chief Safety Officer effective Monday, January 11, 2021. Dr. Vega will report to Chief Medical Officer Tal Zaks, M.D., Ph.D.

    "José brings a strategic level of leadership and deep experience in drug development and pharmacovigilance in global biopharmaceutical companies including Merck and Amgen," said Dr. Zaks. "I am thrilled to welcome José to the Moderna team as we enter the next phase of growth of our company."

    Dr. Vega joins Moderna from Merck (NYSE:MRK) where he led the Global Clinical Safety and Pharmacovigilance organization and served as the Chief Safety Officer for…

    Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that José M. Vega, M.D. joined Moderna as Chief Safety Officer effective Monday, January 11, 2021. Dr. Vega will report to Chief Medical Officer Tal Zaks, M.D., Ph.D.

    "José brings a strategic level of leadership and deep experience in drug development and pharmacovigilance in global biopharmaceutical companies including Merck and Amgen," said Dr. Zaks. "I am thrilled to welcome José to the Moderna team as we enter the next phase of growth of our company."

    Dr. Vega joins Moderna from Merck (NYSE:MRK) where he led the Global Clinical Safety and Pharmacovigilance organization and served as the Chief Safety Officer for Merck Research Laboratories (MRL) since 2013. In this role, he led a global team of nearly 600 safety and pharmacovigilance professionals in Clinical Safety Risk Management, Medical Safety Review, Global Pharmacovigilance, and the EU Qualified Person for Pharmacovigilance (QPPV) groups.

    Prior to Merck, Dr. Vega spent 10 years at Amgen (NASDAQ:AMGN), where he held the role of Vice President, Global Safety for more than 5 years and led global efforts for safety signal detection and assessment, pharmacovigilance, pharmacoepidemiology, and therapeutic area safety. Upon joining Amgen in 2003, Dr. Vega led the Proof of Concept Group in Early Development and served for several years as the Vice President and Therapeutic Area Head for General Medicine in Global Clinical Development.

    Between 1997 and 2003, Dr. Vega served in roles of increasing responsibility at Merck Research Laboratories, initially in Clinical Pharmacology and then in the role of Senior Director in Clinical Drug Metabolism. Prior to joining Merck, Dr. Vega practiced and taught at the Massachusetts General Hospital and Harvard Medical School as an emergency department attending physician for 5 years and as part of an academic primary care and internal medicine practice for more than 2 years.

    "I am delighted to join Moderna and look forward to supporting its mission to deliver on the promise of mRNA science to create a new generation of transformative medicines for patients by fulfilling our uncompromising commitment to patient safety and ensuring the highest standards of quality and compliance," said Dr. Vega.

    Dr. Vega has been a member of the Clinical Trials Transformation Initiative (CTTI) Steering Committee since 2008, representing Amgen from 2008 to 2013 and Merck since 2014. He has been a member of the TransCelerate Pharmacovigilance Steering Committee since 2016 and chaired the committee from 2016 to 2018.

    Dr. Vega received a B.A. in Biochemical Sciences summa cum laude from Harvard College and an M.A. in Biochemistry and Molecular Biology from Harvard University. Dr. Vega received his M.D. degree from Harvard Medical School and completed his internal medicine internship and residency at Massachusetts General Hospital.

    About Moderna

    In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

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  2. Companies aim to build confidence in COVID-19 vaccines via Uber's global network of riders and drivers

    Moderna (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Uber Technologies, Inc. (NYSE:UBER), the world's leading ridesharing and delivery platform, today announced a collaboration to explore ways to help support the uptake of COVID-19 vaccines.

    Moderna and Uber will work together initially to provide accessible, credible information on vaccine safety through Uber's in-app messaging. The two companies will also work with public health and other organizations to identify additional opportunities to support ongoing efforts to broaden access to COVID-19 vaccines. Additional options being…

    Companies aim to build confidence in COVID-19 vaccines via Uber's global network of riders and drivers

    Moderna (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Uber Technologies, Inc. (NYSE:UBER), the world's leading ridesharing and delivery platform, today announced a collaboration to explore ways to help support the uptake of COVID-19 vaccines.

    Moderna and Uber will work together initially to provide accessible, credible information on vaccine safety through Uber's in-app messaging. The two companies will also work with public health and other organizations to identify additional opportunities to support ongoing efforts to broaden access to COVID-19 vaccines. Additional options being evaluated include incorporating ride scheduling directly into the immunization appointment process, and possibly integrating with vaccine providers' systems to text reminders and enable patients to book rides in advance of their first or second immunization appointments.

    "Used by millions of people every day, the Uber platform can both help educate the public about vaccine safety and help eliminate transportation barriers to vaccination. Together with Moderna, we hope to do our part to help increase vaccination awareness and adoption, and we look forward to exploring ways we can help ensure everyone, especially in the hardest-hit communities of color, has access to a vaccine," said Uber CEO Dara Khosrowshahi.

    "As part of our commitment to help address COVID-19, Moderna will be working with a coalition of partners to educate, build trust around and increase awareness of the importance of vaccination in those communities significantly impacted by the pandemic. We look forward to combining our expertise with Uber's capabilities and platform to support this important effort," said Moderna CEO Stéphane Bancel.

    In December, Uber committed 10 million free or discounted rides to help ensure transportation is not a barrier to getting a vaccine. Targeting communities hardest hit by the pandemic, Uber partnered with the National Urban League, National Action Network and the Morehouse School of Medicine. Uber will continue to build a broad coalition of organizations committed to breaking down transportation barriers in these communities.

    The Moderna COVID-19 Vaccine has been authorized for emergency use in the U.S. by the FDA for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older and has been authorized by Health Canada for the immunization of Canadians 18 years of age and older under an Interim Order. The Moderna COVID-19 Vaccine has also been granted a Conditional Marketing Authorization by the European Commission, based upon the recommendation of the European Medicines Agency, which authorizes the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.

    While initially targeting Uber users in the United States, the companies anticipate expanding this partnership globally in the coming months alongside ongoing immunization efforts.

    About Uber

    Uber's mission is to create opportunity through movement. We started in 2010 to solve a simple problem: how do you get access to a ride at the touch of a button? More than 15 billion trips later, we're building products to get people closer to where they want to be. By changing how people, food, and things move through cities, Uber is a platform that opens up the world to new possibilities.

    About Moderna

    In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

    Special Note Regarding Forward-looking Statements

    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding collaborative efforts between Uber and Moderna to facilitate vaccination with the Moderna COVID-19 Vaccine and the provision of ridesharing services to customers by Uber. While Uber and Moderna each believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the companies' beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, those risks listed under the heading "Risk Factors" in Uber's annual and quarterly reports filed with the Securities and Exchange Commission (SEC) and available through Uber's website at www.uber.com and on the SEC's website at www.sec.gov, as well as those risks listed under the heading "Risk Factors" in Moderna's most recent quarterly report on Form 10-Q filed with the SEC and in subsequent filings made by Moderna with the SEC, which are available on Moderna's website at www.modernatx.com and on the SEC's website at www.sec.gov. Except as required by law, Uber and Moderna each disclaim 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.

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  3. Swiss Federal Government has secured 7.5 million doses and first deliveries expected to begin in January

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland.

    The authorization is given according to the ordinary approvals procedure and is based on a rolling submission of data and the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30.

    "Having our COVID-19 Vaccine Moderna authorized in Switzerland is an important milestone for us," said Stéphane Bancel, Chief…

    Swiss Federal Government has secured 7.5 million doses and first deliveries expected to begin in January

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland.

    The authorization is given according to the ordinary approvals procedure and is based on a rolling submission of data and the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30.

    "Having our COVID-19 Vaccine Moderna authorized in Switzerland is an important milestone for us," said Stéphane Bancel, Chief Executive Officer of Moderna. "Switzerland has played a critical role in Moderna's history since our early days and it means a lot to us that we can now provide a highly effective vaccine to help protect the citizens of Switzerland."

    The Swiss Federal Government has secured 7.5 million doses of the COVID-19 Vaccine Moderna. Following today's authorization, the first deliveries are expected to begin in Switzerland in the next week.

    Moderna has also received authorization for its COVID-19 vaccine from regulatory authorities in the United States, Canada, Israel, the European Union and the United Kingdom. Additional authorizations are currently under review in other countries and by the World Health Organization.

    To learn more about Moderna's work on COVID-19 Vaccine Moderna, visit www.modernatx.com/COVID19.

    About the COVID-19 Vaccine Moderna

    The COVID-19 Vaccine Moderna (referred to in the U.S. as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID's Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, the Phase 2 study completed enrolment.

    Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of the vaccine was published in The New England Journal of Medicine. On November 30, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On December 3, a letter to the editor was published in The New England Journal of Medicine reporting that participants in the Phase 1 study of the Moderna COVID-19 Vaccine retained high levels of neutralizing antibodies through 119 days following first vaccination (90 days following second vaccination).

    Authorized Use

    The COVID-19 Vaccine Moderna has been granted temporary approval by Swissmedic, the Swiss Agency for Therapeutic Products, based upon the recommendation of the Human Medicines Expert Committee (HMEC), which authorizes the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.

    About Moderna

    In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

    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 regarding: the Company's development of a vaccine against the novel coronavirus, and plans for the supply and distribution of the Moderna COVID-19 Vaccine to Switzerland, and the timing of deliveries of the vaccine. 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: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or emergency use authorization applications may be filed and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q 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 www.sec.gov. 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 hereof.

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  4. Seasonal flu vaccine program will cover four seasonal viruses recommended by the World Health Organization (WHO)

    HIV vaccine program to accelerate human validation of novel vaccination strategies

    Nipah vaccine program established against a virus of public health concern

    Moderna now has one commercial medicine and 24 development programs

    Multiple therapeutic programs anticipated to see clinical proof of concept data in 2021

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it is expanding its pipeline of innovative vaccines with three new development programs based on the clinical success of its infectious disease vaccine portfolio to date. This announcement…

    Seasonal flu vaccine program will cover four seasonal viruses recommended by the World Health Organization (WHO)

    HIV vaccine program to accelerate human validation of novel vaccination strategies

    Nipah vaccine program established against a virus of public health concern

    Moderna now has one commercial medicine and 24 development programs

    Multiple therapeutic programs anticipated to see clinical proof of concept data in 2021

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it is expanding its pipeline of innovative vaccines with three new development programs based on the clinical success of its infectious disease vaccine portfolio to date. This announcement reflects the Company's commitment to accelerating its infectious disease portfolio based on Moderna's experience with its COVID-19 vaccine. The development programs announced today are mRNA vaccine candidates against seasonal flu, HIV and the Nipah virus. Moderna also announced an expansion of its respiratory syncytial virus (RSV) vaccine program into older adults.

    "The uniquely challenging year of 2020 for all of society proved to be an extraordinary proof-of-concept period for Moderna," said Stéphane Bancel, Moderna's chief executive officer. "Even as we have shown that our mRNA-based vaccine can prevent COVID-19, this has encouraged us to pursue more-ambitious development programs within our prophylactic vaccines modality. Today we are announcing three new vaccine programs addressing seasonal flu, HIV and the Nipah virus, some of which have eluded traditional vaccine efforts, and all of which we believe can be addressed with our mRNA technology. Beyond vaccines, we are extending our mRNA development work to a total of 24 programs across five therapeutic areas."

    Mr. Bancel will present an update on the Company and its pipeline of mRNA development programs on Monday, January 11, 2021 at 4:30 p.m. ET at the 39th Annual J.P. Morgan Healthcare Conference. The presentation will be followed by a question-and-answer session. A live webcast of both the presentation and question and answer session will be available under "Events & Presentations" in the investors section of Moderna's website at investors.modernatx.com. A replay of the webcast will be archived on Moderna's website for 30 days following the presentation.

    Moderna currently has 24 mRNA development programs in its portfolio with 13 having entered the clinic. The Company's updated pipeline can be found at www.modernatx.com/pipeline.

    About Moderna's New Infectious Disease Vaccine Development Programs

    • Flu vaccine (mRNA-1010, mRNA-1020, mRNA-1030): Seasonal flu (type A and type B) epidemics occur seasonally and vary in severity each year, causing respiratory illnesses and placing substantial burden on healthcare systems. The WHO estimates globally about 3,000,000-5,000,000 severe cases of flu each year, and 290,000-650,000 flu-related respiratory deaths. Approximately 8% of the U.S. population experiences symptoms from flu each year in the US, with 140,000-810,000 hospitalizations and 12,000-61,000 deaths per year. Peak flu activity is seen in temperate climates from fall to winter and is reflected in increases in outpatient visits, urgent care visits, and hospitalizations. In the U.S., the estimated average economic burden of flu is approximately $11 billion per year. The Company plans to explore potential combination vaccines against flu, SARS-CoV-2, RSV and human metapneumovirus (hMPV). The Company's first-generation flu program will evaluate multiple candidates comprising multiple antigen combinations against the four seasonal viruses recommended by the WHO. The Company expects to begin phase 1 clinical trials for the program in 2021.



    • HIV vaccine (mRNA-1644 & mRNA-1574): HIV is the virus responsible for acquired immunodeficiency syndrome (AIDS), a lifelong, progressive illness with no effective cure. Approximately 38 million people worldwide are currently living with HIV with 1.2 million in the U.S. Approximately 2 million new infections of HIV are acquired worldwide every year and approximately 690,000 people die annually due to complications from HIV/AIDS. The primary routes of transmission are sexual intercourse and IV drug use, putting young adults at the highest risk of infection. From 2000 to 2015, a total of $562.6 billion globally was spent on care, treatment and prevention of HIV, representing a significant economic burden. mRNA-1644, a collaboration with the International AIDS Vaccine Initiative (IAVI) and the Bill and Melinda Gates Foundation (BMGF), is a novel approach to HIV vaccine strategy in humans designed to elicit broadly Neutralizing HIV-1 Antibodies (bNAbs). A Phase 1 study for mRNA-1644 will use iterative human testing to validate the approach and antigens and multiple novel antigens will be used for germline-targeting and immuno-focusing. A second approach, mRNA-1574, is being evaluated in collaboration with the National Institutes of Health (NIH) and includes multiple native-like trimer antigens. The Company expects to begin phase 1 clinical trials for both mRNA-1644 and mRNA-1574 in 2021.



    • Nipah virus (NiV) Vaccine (mRNA-1215): NiV is a zoonotic virus transmitted to humans from animals, contaminated food, or through direct human-to-human transmission and causes a range of illnesses including fatal encephalitis. Severe respiratory and neurologic complications of NiV have no treatment other than intensive supportive care. The case fatality rate among those infected is estimated at 40-75%. NiV outbreaks cause significant economic burden to impacted regions due to loss of human life and interventions to prevent further spread, such as the slaughter of infected animals. NiV has been identified as the cause of isolated outbreaks in India, Bangladesh, Malaysia, and Singapore since 2000 and is included on the WHO R&D Blueprint list of epidemic threats needing urgent R&D action. mRNA-1215 was co-developed by Moderna and the NIH's Vaccine Research Center (VRC).

    Moderna's pipeline is organized into six modalities based on similar mRNA technologies, delivery technologies and manufacturing processes. The Company's approach is to leverage early programs within a modality to generate clinical data and insights that reduce the technology risk of subsequent programs and accelerate the expansion of the pipeline in that modality. Positive phase 1, 2 and 3 data from Moderna's infectious disease vaccine portfolio and positive phase 1 data from its chikungunya antibody program have de-risked its prophylactic vaccines and systemic therapeutics & cell surface modalities respectively. Beyond these core modalities, the Company has four exploratory modalities in which it is actively pursuing clinical proof of concept.

    Summary of Program Updates by Modality:

    Core Modalities

    Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need – including complex vaccines with multiple antigens for common diseases, as well as vaccines against threats to global public health. The Company's global public health portfolio is focused on epidemic and pandemic diseases and often developed in collaborations with governments and non-profit organizations.

    Vaccines requiring complex antigens and against highly prevalent infections

    • Cytomegalovirus (CMV) vaccine (mRNA-1647): Positive interim data from the phase 2 study assessing the safety, reactogenicity, and immunogenicity of different dose levels of mRNA-1647 were presented at Moderna's annual R&D Day. Based on the interim analysis of the phase 2 study, the 100 μg dose has been chosen for the phase 3 pivotal study, which is expected to begin this year. Moderna owns worldwide commercial rights for mRNA-1647.
    • Epstein-Barr virus (EBV) vaccine (mRNA-1189): mRNA-1189 is a vaccine against EBV containing five mRNAs that encode viral proteins (gp350, gB, gp42, gH and gL) in EBV. Similar to Moderna's CMV vaccine (mRNA-1647), the viral proteins in mRNA-1189 are expressed in their native membrane-bound form for recognition by the immune system. There is no approved vaccine for EBV. Moderna owns worldwide commercial rights to mRNA-1189.



    Vaccines against respiratory infections

    • Moderna COVID-19 Vaccine (mRNA-1273) authorization: On December 18, the U.S. Food and Drug Administration (FDA) authorized the emergency use of mRNA-1273, Moderna's vaccine against COVID-19, in individuals 18 years of age or older. The Moderna COVID-19 Vaccine is also authorized by Canada, Israel, the United Kingdom and the European Union. Additional authorizations are currently under review in additional markets including Singapore, Switzerland and by the WHO. On December 30, interim safety and primary efficacy results from the Phase 3 trial of the Moderna COVID-19 Vaccine (mRNA-1273) were published in the New England Journal of Medicine. The primary endpoint of the Phase 3 COVE study was based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This final analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the Moderna COVID-19 Vaccine group, corresponding to a 94% vaccine efficacy (95% CI 89.3-96.8%; p<0.0001). The most common solicited adverse reactions (ARs) after the two-dose series was injection site pain (86.0%). Solicited systemic adverse events occurred more often in the Moderna COVID-19 vaccine group (54.9% and 79.4%) than in the placebo (42.2% and 36.5%) group after both the first dose and the second dose respectively and were most commonly headache, fatigue and myalgia. While the majority of these ARs were mild (grade 1) or moderate (grade 2), there was a higher occurrence of severe (grade 3) reactions in the Moderna COVID-19 Vaccine group after the first (2.9%) and second (15.8%) injections. The majority of local solicited ARs occurred within the first one to two days after injection and generally persisted for a median of one to two days. Safety data continues to accrue, and the study continues to be monitored by an independent Data Safety Monitoring Board (DSMB) appointed by the NIH. All participants in the COVE study will be monitored for two years after their second dose to assess long-term protection and safety. Additional data to be collected will include longer term safety follow-up, duration of protection against COVID-19, and efficacy against asymptomatic SARS-CoV-2 infection. BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), partially supported the research and development of mRNA-1273 with federal funding under Contract no. 75A50120C00034. A summary of the Company's work to date on COVID-19 can be found here. Moderna retains worldwide rights to develop and commercialize mRNA-1273.
    • Moderna COVID-19 Vaccine (mRNA-1273) additional clinical studies: Moderna is also conducting a phase 2/3 study of the Moderna COVID-19 Vaccine in adolescents 12 to under 18 years of age. Additional studies are planned to evaluate the Moderna COVID-19 Vaccine in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.
    • Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3) vaccine (mRNA-1653): Sites have resumed dosing seropositive pediatric participants (12-36 months of age) in the Phase 1 study of hMPV/PIV3 study (mRNA-1653) following the COVID-19 related study disruption. Moderna owns worldwide commercial rights to mRNA-1653.
    • Respiratory syncytial virus (RSV) vaccine (mRNA-1345): mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state. The first cohort of the phase 1 study of mRNA-1345 is fully enrolled. This phase 1 study includes initial dosing in younger adults, followed by age de-escalation into children. The Company today, announced its plan to amend the protocol to include evaluation of mRNA-1345 in older adults who are also at risk of significant RSV disease. Going forward, the Company intends to evaluate the potential of combinations of mRNA-1345 with its vaccines against other respiratory pathogens in children and separately in older adults. There is no approved vaccine for RSV. Moderna owns worldwide commercial rights to mRNA-1345.

    Public Health Vaccines

    • Zika virus vaccine (mRNA-1893): All dose cohorts (10, 30, 100 and 250 µg) in the phase 1 study of mRNA-1893 have completed enrollment. Moderna is preparing for a phase 2 study of mRNA-1893. mRNA-1893 is being developed in collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Moderna owns worldwide commercial rights to mRNA-1893.
    • Pandemic influenza/H7N9 vaccine (mRNA-1851): Discussions regarding funding the Company's pandemic influenza/H7N9 vaccine program through approval are ongoing.

    Systemic Secreted & Cell Surface Therapeutics: In this modality, mRNA is delivered systemically to create proteins that are either secreted or expressed on the cell surface.

    • Antibody against the chikungunya virus (mRNA-1944): Positive interim data from the Phase 1 study evaluating escalating doses of mRNA-1944 in the 0.6 mg/kg dose with steroid premedication cohort and two doses of 0.3 mg/kg (without steroid premedication) given one week apart cohort were presented at Moderna's annual R&D Day and demonstrated dose-dependent increases in levels of antibody against chikungunya. Safety and increased CHKV-IgG production in the two-dose regimen shows the platform's ability for repeat dosing.

    Exploratory Modalities

    Cancer Vaccines: These programs focus on stimulating a patient's immune system with antigens derived from tumor-specific mutations to enable the immune system to elicit a more effective anti-tumor response.

    • Personalized cancer vaccine (PCV) (mRNA-4157): The randomized Phase 2 study investigating a 1 mg dose of mRNA-4157 in combination with Merck's pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma is ongoing. The Phase 1 study is ongoing. Moderna shares worldwide commercial rights to mRNA-4157 with Merck.



    • Mutant KRAS vaccine (mRNA-5671 or V941): The phase 1 open-label, multi-center study to evaluate the safety and tolerability of mRNA-5671 both as a monotherapy and in combination with pembrolizumab, led by Merck, is ongoing. Moderna shares worldwide commercial rights to mRNA-5671 with Merck.



    Intratumoral Immuno-Oncology: These programs aim to drive anti-cancer T cell responses by injecting mRNA therapies directly into tumors.

    • OX40L (mRNA-2416): The phase 1/2 study of mRNA-2416 alone and in combination with durvalumab (IMFINZI®) is ongoing. The phase 2 dose expansion study of mRNA-2416 in combination with durvalumab in ovarian cancer patients is enrolling and the first patients have been dosed. Moderna owns worldwide commercial rights to mRNA-2416.



    • OX40L/IL-23/IL-36γ (Triplet) (mRNA-2752): The phase 1 trial evaluating mRNA-2752 as a single agent and in combination with durvalumab in patients with advanced solid tumor malignancies and lymphoma is ongoing. mRNA-2752 is an investigational mRNA immuno-oncology therapy that encodes a novel combination of three immunomodulators. Moderna owns worldwide commercial rights to mRNA-2752.



    • IL-12 (MEDI1191): The phase 1 open-label, multi-center study of intratumoral injections of MEDI1191 alone and in combination with durvalumab in patients with advanced solid tumors, led by AstraZeneca, is ongoing. MEDI1191 is an mRNA encoding for IL-12, a potent immunomodulatory cytokine. Moderna shares worldwide commercial rights to MEDI1191 with AstraZeneca.

    Localized Regenerative Therapeutics: Localized production of proteins has the potential to be used as a regenerative medicine for damaged tissues.

    • VEGF-A (AZD8601): The phase 2a study of AZD8601 VEGF-A, which is being developed for patients with ischemic heart disease undergoing coronary artery bypass grafting (CABG) surgery with moderately impaired systolic function, led by AstraZeneca, is ongoing. Moderna has licensed worldwide commercial rights to AZD8601 to AstraZeneca.

    Systemic Intracellular Therapeutics: These programs aim to deliver mRNA into cells within target organs as a therapeutic approach for diseases caused by a missing or defective protein.

    • Propionic acidemia (PA) (mRNA-3927): Sites are being initiated, with entry into the clinic expected in 2021. The Company will be looking for biomarkers as early indicators for therapeutic impact. Moderna owns worldwide commercial rights to mRNA-3927.

    Information about each development candidate in Moderna's pipeline, including those discussed in this press release, can be found on the investor relations page of Moderna's website: https://investors.modernatx.com.

    Corporate Updates

    • Continued growth across organization: Moderna ended 2020 with approximately 1,300 full time employees, an increase from approximately 820 full time employees at the end of 2019. Moderna was named a top employer by Science for the sixth year in a row.

    • Announced additions to the Moderna team:

      • Corinne Le Goff, Pharm.D., MBA, will join Moderna as Chief Commercial Officer effective Tuesday, January 19, 2021. Dr. Le Goff served as senior vice president and president of the U.S. Business Organization at Amgen (NASDAQ:AMGN). Prior to that, Dr. Le Goff held a number of senior international roles at Roche Group (SWX: RO), including President of Roche France and Global Product Strategy Head of Neuroscience & Rare Diseases, and leadership roles at Sanofi (NASDAQ:SNY) and Pfizer (NYSE:PFE) in the United States.

      • Ruchira Glaser, M.D., MSCE, joined Moderna as the Senior Vice President, Therapeutic Area Head for the Rare Disease, Autoimmune, and Cardiovascular Therapeutic Areas, where she will oversee development for our broad therapeutics portfolio outside of oncology. Dr. Glaser joins from GlaxoSmithKline (NYSE:GSK), where she was most recently Head of Clinical Sciences for the Respiratory and Specialty areas, including rare diseases, immunology and anemia. Prior to that, Dr. Glaser spent 10 years as an interventional cardiologist and clinical researcher at the University of Pennsylvania.

    • Continued strong cash position: The Company expects cash, cash equivalents, and investments as of December 31, 2020 to be approximately $5.25 billion (unaudited), as compared to $1.26 billion as of December 31, 2019, including customer deposits of $2.81 billion for future supply of product.

    • Moderna has signed Advance Purchase Agreements (APAs) for the delivery of its COVID-19 Vaccine. To date, the product revenue associated with these APAs for FY 2021 is $11.7 billion. These doses of Moderna COVID-19 Vaccine are expected to be delivered in 2021. The company is in active discussions to sign additional APAs for deliveries in 2021 and 2022. Moderna has also made a proposal to COVAX via a UNICEF tender to supply low-and-mid income countries.

    • Commitment to access: The Company published seven principles as part of its Commitment to Vaccines and Therapeutics Access.

    • Shareholder Letter: Moderna CEO Stéphane Bancel published a letter to shareholders on January 4, 2021.

    Key 2021 Investor and Analyst Event Dates

    • Vaccines Day– April 14
    • Science Day – May 27
    • R&D Day – September 9

    About Moderna

    In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

    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: development programs for vaccines against influenza, HIV and the Nipah virus and the specifics of those programs, including the timing of potential clinical trials; the timing for receipt of proof of concept clinical data from multiple therapeutics; the potential advantages of infectious disease vaccines; the development of combination vaccines against multiple diseases; the conduct of studies for the Company's vaccines against CMV, Zika virus, anti-cancer vaccines (i.e., OX40L, OX40L/IL-23/IL-36γ and IL-12), VEGF-A and PA; the potential for the Moderna COVID-19 Vaccine to prevent COVID-19 disease and slow the spread of SARS-CoV-2, the safety profile for the Moderna COVID-19 Vaccine; plans for further clinical trials for the Moderna COVID-19 Vaccine; the potential for repeat dosing of certain therapeutics; the Company's plans for research and development and timelines for any individual product or the platform as a whole; cash, cash equivalents and investment balances; and discussions related to further sales of the Moderna COVID-19 Vaccine. 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: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or emergency use authorization applications may be filed and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q 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 www.sec.gov. 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 hereof.

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  5. UK MHRA authorization is based on a rolling review of COVID-19 Vaccine Moderna data, including data from the Phase 3 COVE study

    UK government secured an additional 10 million doses for a total of 17 million doses of the vaccine with supply beginning in early 2021

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved its mRNA vaccine against COVID-19 (COVID-19 Vaccine Moderna) for use under Regulation 174. The temporary authorization permits the supply of COVID-19 Vaccine Moderna in Great Britain and is based upon the advice of the UK Commission on Human Medicines.

    "We appreciate the…

    UK MHRA authorization is based on a rolling review of COVID-19 Vaccine Moderna data, including data from the Phase 3 COVE study

    UK government secured an additional 10 million doses for a total of 17 million doses of the vaccine with supply beginning in early 2021

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved its mRNA vaccine against COVID-19 (COVID-19 Vaccine Moderna) for use under Regulation 174. The temporary authorization permits the supply of COVID-19 Vaccine Moderna in Great Britain and is based upon the advice of the UK Commission on Human Medicines.

    "We appreciate the confidence shown by the UK MHRA in COVID-19 Vaccine Moderna with this decision, which marks an important step forward in the global fight against COVID-19," said Stéphane Bancel, Chief Executive Officer of Moderna. "I want to thank the MHRA and the Commission on Human Medicines' reviewers for their tireless efforts. The authorization of a product developed by Moderna is a significant milestone on the Company's 10-year journey, and I would like to thank all our colleagues that have helped us get to this point."

    The United Kingdom government has also exercised its option to purchase an additional 10 million doses of the COVID-19 Vaccine Moderna, bringing its confirmed order commitment to 17 million doses. The first deliveries of the COVID-19 Vaccine Moderna to the UK from Moderna's dedicated non-U.S. supply chain are expected to commence early in 2021.

    The UK is the fifth jurisdiction to authorize COVID-19 Vaccine Moderna, following the United States on December 18, 2020, Canada on December 23, 2020, Israel on January 4, 2021 and the European Union on January 6, 2021. Additional authorizations are currently under review in a number of countries including Singapore and Switzerland.

    The decision from the MHRA is based on a rolling submission of data that was announced on October 27, 2020. The MHRA based its authorization on the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30.

    To learn more about Moderna's work on the COVID-19 Vaccine Moderna, visit www.modernatx.com/COVID19.

    About the COVID-19 Vaccine Moderna

    The COVID-19 Vaccine Moderna (referred to in the U.S. as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID's Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, the Phase 2 study completed enrolment.

    Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of the vaccine was published in The New England Journal of Medicine. On November 30, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, the Company also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 3, a letter to the editor was published in The New England Journal of Medicine reporting that participants in the Phase 1 study of the Moderna COVID-19 Vaccine retained high levels of neutralizing antibodies through 119 days following first vaccination (90 days following second vaccination).

    Authorized Use

    The COVID-19 Vaccine Moderna has been authorized by the Medicines and Healthcare products Regulatory Agency (MHRA), based upon the recommendation of the Commission on Human Medicines, which authorizes the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and BARDA. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

    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 regarding: the Company's development of a vaccine against the novel coronavirus, and plans for the supply and distribution of the Moderna COVID-19 Vaccine to the United Kingdom. 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: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or emergency use authorization applications may be filed and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q 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 www.sec.gov. 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 hereof.

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