PEMGARDA shows potency against SARS-CoV-2 variants

WALTHAM, Mass. - Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company, announced today that its investigational monoclonal antibody, PEMGARDA™ (pemivibart), retains neutralizing activity against a range of SARS-CoV-2 variants, including the rising KP.3.1.1 strain. The Center for Disease Control (CDC) reports that KP.3.1.1 is currently the only major variant increasing in proportion across the United States.

The company's recent in vitro studies indicate that pemivibart can neutralize not only KP.3.1.1 but also LB.1 and other tested SARS-CoV-2 variants. These variants contain mutations such as Q493E and S31 deletion that are prevalent in circulating strains and have potential implications for viral antibody evasion. Despite these mutations, the primary structure of the pemivibart epitope has remained stable across the majority of viral sequences since the initial Omicron BA.1 variant.

Robert Allen, Ph.D., Invivyd's Chief Scientific Officer, commented on the breadth of pemivibart's activity, emphasizing the company's commitment to developing antibodies that maintain efficacy amidst the ongoing evolution of the virus. Marc Elia, Chairman of the Invivyd Board of Directors, also expressed confidence in the data, which reinforce pemivibart's neutralizing capabilities.

In addition to pemivibart, Invivyd is developing VYD2311, another monoclonal antibody candidate with promising neutralization potency against the same contemporary viruses. The company has submitted the latest data to the FDA for expected updates to the PEMGARDA Healthcare Providers Fact Sheet.

PEMGARDA, a half-life extended monoclonal antibody, targets the SARS-CoV-2 spike protein receptor binding domain and has been authorized for emergency use by the FDA for pre-exposure prophylaxis in certain immunocompromised individuals. It is not approved for treatment or post-exposure prophylaxis of COVID-19. The company has also received emergency use authorization for its first monoclonal antibody under its INVYMAB™ platform, which aims to rapidly generate new antibodies to combat evolving viral threats.

This news is based on a press release statement from Invivyd, Inc. and does not constitute an endorsement of the company or its products.

In other recent news, Invivyd Inc. has been making significant strides in the biopharmaceutical sector. The company's Phase 3 trial of PEMGARDA, a monoclonal antibody for COVID-19 prevention, demonstrated an 84% reduction in symptomatic COVID-19 risk, a development that has been well received by investors and analysts alike. H.C. Wainwright maintained a Buy rating on Invivyd, setting a price target of $15.00, reflecting confidence in the company's performance.

Invivyd's second-quarter financials showed revenues reaching $2.3 million, falling short of the anticipated $6.9 million but the company expects revenue growth in the second half of the year. The company is also advancing a pipeline molecule, VYD2311, and expanding access to PEMGARDA for immunocompromised individuals. However, supply constraints are affecting Invivyd's ability to expand in international markets.

On the corporate front, Invivyd appointed Timothy Lee as Chief Commercial Officer, a move expected to enhance the company's commercial strategy. The company also submitted an EUA amendment request to the FDA for PEMGARDA's use in treating mild-to-moderate COVID-19 in certain immunocompromised patients. These are the recent developments in Invivyd's ongoing efforts to combat respiratory viruses.

InvestingPro Insights

As Invivyd, Inc. (NASDAQ:IVVD) continues its efforts to combat SARS-CoV-2 variants with investigational treatments like PEMGARDA™, the company's financial health and market performance are of interest to investors. A look at the InvestingPro data reveals some key metrics that could influence investor decisions:

• The company's market capitalization stands at a modest $101.55 million, which reflects its scale within the biopharmaceutical industry.
• With a negative P/E ratio of -0.72 and an adjusted P/E ratio for the last twelve months as of Q2 2024 at -0.5, Invivyd is currently not profitable, a factor that is often crucial for investors assessing the company's near-term financial health.
• InvestingPro data also shows a significant gross profit margin of 96.11% for the same period, indicating that while the company is generating profit on its goods or services, it is still facing challenges with its bottom line.

Turning to the InvestingPro Tips, two insights stand out for Invivyd:

1. Despite holding more cash than debt, which is typically a positive sign of financial stability, the company is rapidly burning through its cash reserves.
2. The stock has experienced a notable decline, taking a big hit over the last week, month, and three months, with the price falling significantly during these periods.

For investors considering Invivyd as part of their portfolio, these InvestingPro Tips are essential considerations. The company's ability to manage its cash burn and reverse the negative trends in stock performance will be critical factors to watch. For those seeking more in-depth analysis, there are additional tips available on InvestingPro, providing a more comprehensive understanding of Invivyd's financial and market position.

For more detailed insights and additional tips on Invivyd, Inc., interested parties can visit https://www.investing.com/pro/IVVD, where a total of 12 InvestingPro Tips are available to help inform investment decisions.

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