Ms. Hamutal Yitzhak reports

ELSE NUTRITION ACHIEVES CONSTRUCTIVE DEVELOPMENT IN FDA DIALOGUE, TAKING ENCOURAGING STEPS TOWARD THE NEXT REGULATORY EFFORTS FOR ITS PLANT-BASED INFANT FORMULA

Else Nutrition Holdings Inc. has made continued progress in its continuing engagement to develop a regulatory pathway with the U.S. Food and Drug Administration (FDA) regarding its plant-based infant formula. In recent discussions, the company achieved what it views as a significant breakthrough: reaching alignment with the FDA on how to advance to the next regulatory phase, including the studies and product optimization required to do so.

Constructive, science-driven dialogue with the FDA

Else's recent interactions with the FDA were substantive and scientific. The discussions covered scientific requirements for advancing the company's infant formula as well as additional methodologies proposed by both the FDA and Else to support the evaluation of the product. The company believes this exchange is an important step forward in its regulatory engagement, moving the discussion toward a defined, mutually understood path forward. While additional clarity and regulatory steps are necessary to achieve full alignment on the development pathway, the recent engagements demonstrate a meaningful advancement for the infant formula program.

Formulation optimization ahead of the PER (protein efficiency ratio) and clinical studies

A central focus of the discussions was optimizing Else's infant formula to maximize the likelihood of success in the coming studies: the protein efficiency ratio (PER) study, DIAAS (Digestible Indispensable Amino Acid Score), and the subsequent clinical study. Based on these discussions, Else intends to make targeted refinements to its formulation paired with advanced study methodologies. These refinements are designed to further strengthen the product's protein quality and nutritional performance while preserving the whole-food, plant-based, clean-label profile that defines the Else brand.

Independent expert assessment and government affairs measures

To support this process, Else has engaged internationally renowned experts in infant nutrition, protein quality assessment and regulatory science. Based on these experts' assessment, the company believes that, with the planned optimizations, it is well positioned to meet the FDA's requirements, proceed to the PER study and advance to the next phase of the regulatory process.

"This is a significant milestone for Else and an important step for our U.S. regulatory program," said Hamutal Yitzhak, co-founder and chief executive officer of Else Nutrition. "Our dialogue with the FDA has become a genuinely constructive, science-based conversation focused on how to move forward. We now have a much clearer understanding of what the next phase requires. Supported by world-class experts, we are confident in our ability to optimize our formula, meet the FDA's requirements and keep advancing toward bringing the first whole-food, plant-based infant formula to families in the United States."

The recent dialogue with the FDA follows Congress's passage of FY26 Congressional Appropriations Directive Report Language, which requires the FDA to implement and modernize guidance for plant-based, non-soy, non-dairy infant formula.

Broader regulatory momentum

This progress comes as the FDA continues to modernize the U.S. infant formula framework, including through Operation Stork Speed and the inclusion of PER rat bioassay study guidance on the FDA's Foods Program guidance agenda, as the company previously announced on March 10, 2026. Else continues to follow these developments closely and believes they support a clearer, science-based pathway for innovative plant-based infant formulas.

Next steps

Else expects to proceed with the formulation optimization work discussed with the FDA and prepare for the DIAAS and then PER study, followed by the clinical study. Additional clarity and refinement on other regulatory measures are necessary but will continue as the company advances its formula efforts. The company will maintain its close engagement with the FDA and expects to provide further updates as it reaches key milestones.

About Else Nutrition Holdings Inc.

Else Nutrition Holdings is a food and nutrition company focused on developing innovative, clean, plant-based food and nutrition products for infants, toddlers, children and adults. Its whole-food, plant-based, non-dairy and non-soy formulations, made primarily from almonds, buckwheat and tapioca, offer a clean-label, non-GMO (genetically modified organism) alternative to dairy- and soy-based nutrition. Else's products have received numerous industry recognitions.

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