File: '\\swfile\EmailIn\20261111 101200 Attachment RK Else Nutrition PR - 2026 FDA progress final.docx'

NEWS RELEASE

Else Nutrition Achieves Constructive Development in FDA Dialogue, Taking Eencouraging Steps Toward the Next Regulatory Efforts for its Plant-Based Infant Formula

Constructive, science-based dialogue with the FDA yields alignment on several studies and product optimization efforts required to advance to the next phase

Additional methodologies proposed by both the FDA and Else were discussed, along with formulation enhancements necessary designed to support success in the upcoming Protein Efficiency Ratio (PER) study and clinical study

Internationally renowned experts engaged by Else assess that the Company is on track to satisfy FDA requirements, proceed to the PER study and advance to the next phase

VANCOUVER, BC, Nov 11, 2026 /CNW/ - Else Nutrition Holdings Inc. (CSE: BABY) (OTCQX: BABYF) (FSE: 0YL) ("Else" or the "Company"), a pioneer of plant-based, whole-food, dairy-free and soy-free nutrition for infants, toddlers, children and adults, is pleased to announce continued progress in its ongoing 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 and Clinical Studies

A central focus of the discussions was optimizing Else's infant formula to maximize the likelihood of success in the upcoming studies: the Protein Efficiency Ratio ("PER") study, DIAAS, 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 & 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 CEO 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 FDA follows Congress' passage of FY26 Congressional Appropriations Directive Report Language that requires 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 Inc. 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 alternative to dairy- and soy-based nutrition. Else's products have received numerous industry recognitions, including [insert current awards list]. For more information, visit www.elsenutrition.com.

For further information, please contact:

Investor Relations:

Alexandra Schilt

Crescendo Communications, LLC

Office: (212) 671-1020

Email: baby@crescendo-ir.com

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Forward-Looking Information

This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian securities laws (together, "forward-looking statements"). Forward-looking statements in this press release include, without limitation, statements about: the Company's ongoing engagement with the FDA; the anticipated path to the next regulatory phase; the planned optimization of the Company's infant formula; the design, timing, conduct and outcome of the PER study and the clinical study; the Company's ability to meet the FDA's requirements; the assessment of experts engaged by the Company; and the Company's plans to commercialize its infant formula in the United States. Words such as "believes", "expects", "intends", "anticipates", "plans", "will", "may", "could", "positioned" and similar expressions identify forward-looking statements.

Forward-looking statements are based on the Company's current expectations and assumptions. These include that: the FDA's requirements and positions will remain consistent with those discussed in recent interactions; the planned formulation optimizations can be implemented successfully, on time and at reasonable cost; the studies will be conducted as planned and produce favourable results; the experts' assessments are accurate; and the Company will have sufficient capital to fund its regulatory program. These assumptions may prove incorrect.

Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. These include: discussions with the FDA are not an approval, acceptance or endorsement of the Company's products, studies or submissions, and the FDA may require additional or different studies, data or product modifications; the PER study and the clinical study may not achieve their endpoints; the opinions of experts engaged by the Company do not bind the FDA and may not predict its determinations; study timelines may be delayed; FDA policy, guidance or regulations may change; the Company may need additional financing; and the other risk factors described in the Company's public disclosure documents on SEDAR+ at www.sedarplus.ca. Readers are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements in this press release are made as of its date, and the Company undertakes no obligation to update them except as required by applicable law.

SOURCE Else Nutrition Holdings Inc.