Ms. Hamutal Yitzhak reports

ELSE NUTRITION EXPECTED TO BENEFIT FROM FDA REGULATORY PROGRESS ON INFANT FORMULA PROTEIN STANDARDS

Else Nutrition Holdings Inc. has noted the U.S. Food and Drug Administration has formally listed protein efficiency ratio rat bioassay study guidance as an active topic within its foods program regulatory agenda.

For Else Nutrition, the FDA's advancement of PER guidance represents a meaningful step toward regulatory clarity for novel infant formulas, particularly plant-based formulations. Clearer scientific expectations for demonstrating protein quality are expected to reduce regulatory uncertainty and strengthen the pathway for potential FDA clearance of Else's plant-based infant formula in the United States.

FDA's PER guidance development: a catalyst for regulatory clarity

The PER rat bioassay remains one of the FDA-recognized methodologies for demonstrating biological protein quality in infant formulas. However, existing standards are widely considered outdated and have historically created uncertainty for companies developing formulas based on novel or whole-food protein sources, including plant-based protein innovations like Else's.

By advancing PER guidance, the FDA signals an intention to clarify study design, end points and expectations for protein quality validation. Greater transparency around these requirements provides companies with improved visibility into the scope, timeline and cost of required preclinical studies.

For Else Nutrition, this development reduces a key regulatory risk factor associated with bringing its plant-based infant formula to the U.S. market.

Alignment with federal formula modernization efforts

The U.S. infant formula market -- one of the world's largest -- has persistently lacked diversified protein options. Congress and federal agencies have also publicly emphasized the need to expand consumer choice within the U.S. infant formula market with non-dairy, non-soy, plant-based options -- a position Else highlighted in its June, 2025, release.

The FDA's work on PER guidance aligns with broader federal initiatives to modernize infant formula oversight, including operation stork speed, which aims to update regulatory frameworks and nutrient standards for the first time since 1998. Operation stork speed emphasizes formula modernization and regulatory streamlining, improving transparency and building predictable routes for new product approvals.

Strategic implications for Else Nutrition

As most competitors rely on conventional dairy or soy proteins, the updated PER methodology explicitly benefits novel protein matrices by providing science-based standards tailored to modern formulations, enabling Else to demonstrate protein quality credibility on a level regulatory playing field.

As regulatory modernization progresses, Else believes it is well positioned to benefit from structural industry tailwinds, including:

• Increasing demand for clean-label and plant-based nutrition;
• Federal efforts to expand competition and innovation in the U.S. formula market;
• Greater regulatory transparency supporting new product approvals.

A clearer regulatory pathway significantly enhances Else's ability to pursue entry into the multibillion-dollar U.S. infant formula market.

The company believes the alignment between its plant-based innovation strategy and evolving regulatory priorities further strengthens its positioning with long-only institutional investors, environmental, social and governance focused funds, and growth investors seeking companies with identifiable regulatory catalysts.

Hamutal Yitzhak, chief executive officer and co-founder of Else Nutrition, commented: "The FDA's progress on PER guidance is a meaningful inflection point for Else Nutrition. As clarity increases around the scientific and procedural standards required for novel infant formulas, our regulatory road map becomes sharper, more predictable and increasingly aligned with federal efforts to modernize the U.S. formula market. This development strengthens our confidence in the commercial potential of our infant formula program in the United States."

About Else Nutrition Holdings Inc.

Else is a food and nutrition company in the international expansion-stage focused on developing innovative, clean and plant-based food and nutrition products for infants, toddlers, children and adults. Its revolutionary, plant-based, non-soy formula is a clean-ingredient alternative to dairy-based formulas. Since launching its plant-based complete nutrition for toddlers, made of whole foods, almonds, buckwheat and tapioca, the brand has received thousands of powerful testimonials and reviews from parents, gained national retailer support, and achieved rapid sales growth.

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