Rallybio reveals higher FNAIT risk across populations

NEW HAVEN - Rallybio Corporation (NASDAQ:RLYB), a biotechnology firm focused on rare diseases, has announced findings from an epidemiological study indicating a broader risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT) than previously recognized. The data, set to be presented at the American Society of Human Genetics 2024 Annual Meeting in November, suggest that ancestries beyond Caucasian populations carry significant risks for FNAIT, a life-threatening condition affecting fetuses and newborns.

The study found that certain non-Caucasian groups, such as Caribbean Hispanic and African/African American populations, also have notable percentages of women at risk. The analysis, which utilized allele frequencies from gnomAD v4 and the U.S. National Marrow Donor Registry, highlighted the need for routine prenatal screening for FNAIT to offer prophylactic treatment with RLYB212, pending approval.

The research indicates over 30,000 pregnancies annually in North America and major European countries might be at higher risk for FNAIT, a 40% increase from prior estimates. This could represent a $1.6 billion commercial opportunity for treatments.

Rallybio's RLYB212, an anti-HPA-1a antibody, is on track for a Phase 2 trial in the fourth quarter of 2024, targeting pregnant women at higher risk for HPA-1a alloimmunization and FNAIT. FNAIT occurs when an immune incompatibility between an expectant mother and her fetus leads to the mother developing antibodies that can destroy the fetus's platelets, potentially causing severe health issues or death.

The company, in collaboration with HealthLumen, conducted the analysis to improve the understanding of FNAIT's prevalence. The poster detailing the study's findings will be accessible on Rallybio's website after the conference.

Rallybio aims to advance therapies for severe and rare diseases, with other clinical stage programs addressing maternal fetal health, complement dysregulation, hematology, and metabolic disorders. The company's forward-looking statements, including the potential impact of this study and the development of RLYB212, are based on management's current expectations and are subject to risks and uncertainties.

This article is based on a press release statement from Rallybio Corporation.

In other recent news, Rallybio Corporation has announced several significant developments. The company has reported the resignation of Dr. Kush Parmar from the Board of Directors, effective October 31, 2024. This decision was not due to any disagreement with the company's operations, policies, or practices. In addition, Dr. Martin Mackay will resign from his Executive Chairman role at Rallybio by the end of 2024, transitioning to the role of Chairman of the Board and a consultant for the company.

Rallybio has made substantial progress in its drug studies, particularly with RLYB212, a drug candidate aimed at preventing fetal and neonatal alloimmune thrombocytopenia (FNAIT). The company is preparing to launch a Phase 2 dose confirmation trial in the fourth quarter of 2024. Analysts from H.C. Wainwright and Jones Trading have maintained their Buy ratings for Rallybio, while JPMorgan has downgraded Rallybio's stock from Overweight to Neutral.

Rallybio has also secured a strategic equity investment from Johnson & Johnson, which will support Rallybio's Phase 3 trial of nipocalimab for FNAIT treatment. These recent developments reflect Rallybio's ongoing commitment to addressing the needs of patients with severe and rare diseases.

InvestingPro Insights

Rallybio Corporation's (NASDAQ:RLYB) recent epidemiological study findings may have significant implications for the company's future, particularly with the potential increase in the addressable market for FNAIT treatment. As investors look to understand the financial health and market position of Rallybio, key metrics from InvestingPro provide a real-time snapshot of the company's current status:

• Market Cap: Rallybio holds a market capitalization of $45.64 million, reflecting its size within the biotechnology sector.


• Price to Book Ratio: As of the last twelve months, Rallybio's price to book ratio stands at 0.57, suggesting that the company's market value is less than its book value, which can be a point of interest for value investors.


• Stock Performance: The company's stock has experienced a 1-year price total return of -77.37%, indicating significant volatility and a sharp decline in investor confidence over the past year.

InvestingPro Tips highlight several strategic considerations for Rallybio:

• Rallybio holds more cash than debt on its balance sheet, which could provide financial flexibility in advancing its clinical programs, including the development of RLYB212.


• However, the company is quickly burning through cash, a critical factor for investors to monitor, especially as the company progresses towards its Phase 2 trial for RLYB212.

For those interested in a deeper dive, InvestingPro offers additional insights on Rallybio, with a total of 10 InvestingPro Tips available on their platform, including analysis on valuation, profitability, and stock performance trends. To explore these comprehensive tips, visit: https://www.investing.com/pro/RLYB

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