Elasomeran/Imelasomeran

Pictured: Moderna in Cambridge/iStock, hapabapa While revenue is down, research and development spending is up for post-pandemic Moderna as the biotech looks to diversify its product portfolio. The mRNA company released its second-quarter earnings report Thursday, upping COVID-19 vaccine sales expectations for the rest of the year.  With Spikevax its only approved product, revenue for the second quarter was $344 million as COVID-related sales have dropped off significantly across the industry. By comparison, the same quarter last year brought in revenues of $4.7 billion. Still, Moderna reported a narrower-than-expected loss in the quarter and revenue that beat consensus estimates.   Moderna increased its expected sales for Spikevax to between $6 billion and $8 billion for the year, up from its previous forecast of $5 billion. On the earnings call Thursday, Chief Commercial Officer Arpa Garay said that while the company expects U.S. demand of 50 million to 100 million doses this fall “the key variable” will be vaccination rates. An updated version of Spikevax, targeting the XBB lineage has been submitted for regulatory approval ahead of the fall vaccination season.  “But the fact of the matter is, in this first transition year into a commercial endemic market it is difficult to accurately predict market volumes and predict how many Americans will come in this fall for their shots,” Garay said.  Net income in the second quarter was a $1.4 billion loss, attributed primarily to Moderna’s $1.1 billion R&D investment. R&D for the full year is expected to be $4.5 billion, driven by clinical trial expenses and an increase in headcount to support late-stage efforts. The company has about $14.6 billion on hand in cash.  Moderna is looking to diversify its revenue stream with a pipeline full of mRNA therapeutic candidates, including indications in oncology, cardiovascular, autoimmune and rare disease.  Vaccines for respiratory syncytial virus (RSV), flu and cytomegalovirus (CMV) are in the lead. Regulatory submissions have already been completed in the U.S., Europe and Australia for the RSV vaccine in older adults. Flu vaccine mRNA-1010 is now fully enrolled in a Phase III study with an update expected next quarter. The trial is intended to enable accelerated approval of the shot. The company’s CMV Phase III study is over 80% enrolled.   The company is expecting to launch up to five respiratory vaccines—RSV, seasonal flu, combination vaccines, next-gen COVID and flu—from 2024 to 2026.  Arguably the most anticipated candidate in the pipeline is the company’s partnered individualized neoantigen therapy (INT). Coupled with Merck’s blockbuster Keytruda, the two may have finally found success in the elusive cancer vaccine field.   The INT, mRNA-4157, has proven to reduce risk of recurrence or death by 44% when given with Keytruda to patients with high-risk stage III/IV melanoma after surgery, compared to Keytruda alone. A Phase III study is now commencing for patients with stages IIb through IV with the primary endpoint of recurrence-free survival.   Merck and Moderna are now adding an early-stage trial to assess mRNA-4157 with Keytruda in lung cancer. Moderna is scaling manufacturing to support clinical and commercial development of the personalized treatment, preparing to launch in the next one to three years “in multiple indications,” according to the company’s presentation Thursday. On the earnings call, CEO Stephane Bancel boasted that this a “new era of diversified revenue stream” for Moderna with a robust pipeline that will result in an “unprecedented number of mRNA launches in a very short time.”  Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.

The recommendation is based on clinical data for Moderna's bivalent Omicron-targeting COVID-19 vaccine, mRNA.1273.214 Moderna's bivalent Omicron-targeting COVID-19 vaccines (mRNA.1273.214 (BA.1) & mRNA.1273.222 (BA.4/5)) are currently authorized for use in individuals 18 years of age and older in Canada Both bivalents have been shown to trigger a superior antibody response compared to a booster dose of mRNA-1273, the Company's prototype vaccine, against Omicron (BA.4/5) in Phase 2/3 clinical trials CAMBRIDGE, MA / ACCESSWIRE / February 17, 2023 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Health Canada has authorized the use of its Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron) in children and adolescents 6 to 17 years of age. The authorizations are based on a 25 μg booster dose for children ages 6 to 11 years old and a 50 μg booster dose for adolescents 12 to 17 years old, each following a completed primary series of any of the authorized COVID-19 vaccines or a previous booster. "The authorization of a booster dose of mRNA-1273.214 in children and adolescents is a critical step to broaden protection against the Omicron family of variants, and the emergence of new variants of concern in Canada," said Stéphane Bancel, Chief Executive Officer of Moderna. "This decision highlights the effectiveness and safety of our vaccine in this important age group." The pediatric and adolescent authorization is based on clinical trial booster data for Moderna's original vaccine, Spikevax, which was administered to over a thousand participants in each cohort. The application described data from a 25 μg booster dose administered to children ages 6 to 11 years old and a 50 μg booster dose for adolescents 12 to 17 years old, following a completed primary series of the Moderna COVID-19 vaccine. In addition, the application included clinical trial data from a Phase 2/3 studying mRNA-1273.214. "We are pleased with Health Canada's authorization of our bivalent booster for children and adolescents and our continued collaboration to provide boosters to help protect all Canadians from current and future COVID-19 variants of concern, especially as this virus continues to circulate across the country and around the world," said Shehzad Iqbal, Country Medical Director of Moderna Canada. In November 2022, Moderna announced that its bivalent Omicron-targeting booster candidates (mRNA-1273.214 and mRNA-1273.222) trigger a superior antibody response compared to a booster dose of mRNA-1273, the Company's prototype vaccine, against Omicron (BA.4/BA.5) in Phase 2/3 clinical trials. Both bivalent vaccines also met non-inferiority immunogenicity criteria to the original strain. About Moderna In 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 autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight 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 regarding: the Company's development of bivalent vaccine candidates against COVID-19 (mRNA-1273.222 and mRNA-1273.214); the ability of mRNA-1273.214 to protect children against COVID-19; the ability of mRNA-1273.214 and mRNA-1273.222 to induce higher neutralizing antibody titers against Omicron variants in adults than the Company's vaccine candidate against the ancestral strain of SARS-CoV-2 (mRNA-1273); and authorization of mRNA-1273.214 in Canada for administration in children and adolescents ages 6-17 by Health Canada. 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 those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K and the Quarterly Report on Form 10-Q for the quarter 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: International Media: Luke Mircea Willats Senior Director, Corporate Communications Luke.Mirceawillats@modernatx.com Canada Media: Sacha Kennedy Director, Communications & Media Relations, Canada sacha.kennedy@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: