Else Nutrition H Stock Price, News & Analysis

Else Nutrition (OTCQX: BABYF) welcomes a significant legislative development as the U.S. House Appropriations Committee passes the FY2026 Agriculture and FDA Appropriations Bill. The legislation specifically directs the FDA to streamline approval pathways for plant-based, non-soy, and non-dairy infant formulas.

The bill includes crucial language supporting alternative infant formula access and calls for formal regulatory guidance for non-dairy, non-soy plant-based formulas. This initiative is part of Operation Stork Speed, the Administration's effort to accelerate innovation in infant formula. While the legislation still needs full House approval, it represents a significant step toward expanding the U.S. infant formula market and potentially expediting Else Nutrition's market access.

Else Nutrition Holdings (BABYF) has received a cease trade order (CTO) from the British Columbia Securities Commission due to delayed filing of its Q1 2025 financial statements and related documents. The CTO prohibits trading of company securities in Canada until the interim filings are completed and the order is revoked. Limited exceptions exist for non-insider beneficial shareholders who acquired securities before June 16, 2025, allowing sales through foreign regulated markets via registered Canadian investment dealers. The company expects to file the required documents by June 30, 2025. Additionally, the Toronto Stock Exchange has granted an extension for the company's annual general meeting from June 30 to July 31, 2025.

Else Nutrition (BABYF) welcomes three major U.S. federal developments that could revolutionize the infant formula market, particularly for plant-based alternatives. The FDA-commissioned National Academy of Sciences study recommends replacing the outdated Protein Efficiency Ratio test with modern standards, aligning with Else's regulatory approach. Congressional Republican Appropriators have urged the FDA to create a modernized pathway for plant-based infant formula, while the Administration launched 'Operation Stork Speed' to streamline regulatory processes. These developments could pave the way for Else Nutrition to commercialize the world's first whole-food, dairy-free infant formula. The company is mobilizing stakeholders through a grassroots campaign to advocate for inclusive, evidence-based nutrition standards.

Else Nutrition (BABYF) reported its fiscal year 2024 results, showing a 14.8% revenue decline to $8 million from $9.4 million in 2023. The company faced significant challenges including funding constraints, inventory shortages, and limited marketing budget. Operating expenses decreased 20% to $13.6 million from $16.9 million in 2023, with cash balance at $0.3 million as of December 31, 2024. Management implemented strategic changes including cost reduction, operational optimization, and closure of Israel lab. Notable achievements include launching Adult Ready-to-Drink product and expanding Kids RTD retail presence. The company is engaged with FDA's Operation Stork Speed initiative to modernize guidelines for plant-based infant formula. Future plans include expanding retail distribution, scaling European production, and enhancing brand visibility.

Else Nutrition (BABYF) CEO Hamutal Yitzhak published an op-ed in The Washington Times discussing Operation Stork Speed, an initiative aimed at modernizing infant formula regulations and increasing access to innovative nutrition options. The company has developed a plant-based infant formula as an alternative to dairy and soy-based products, targeting families with dietary restrictions and allergen sensitivities.

The company has completed pre-clinical studies and received IRB approval for its infant growth clinical study protocol. Else Nutrition is currently awaiting FDA authorization to begin clinical trials in the United States, which may be expedited through Operation Stork Speed. The initiative, launched by the Trump administration and HHS Secretary Robert F. Kennedy Jr., focuses on improving regulatory review and safety of infant formula while encouraging innovation.

Else Nutrition (BABYF) has expanded its U.S. retail presence by launching its Ready-to-Drink (RTD) products in 1,000 stores of a major grocery retail chain starting May 2025. The company's clean-label Kids RTD shakes, which were initially launched in 2024, offer a dairy-free and soy-free nutritional option for children. The products are minimally processed and whole-food-based, distinguishing themselves from other ultra-processed drinks in the market.

CEO Hamutal Yitzhak highlighted that this expansion reflects the growing consumer demand for plant-based options in the Kids RTD category. The company specializes in plant-based nutrition for early life and adult nutrition.

Else Nutrition Holdings (TSX: BABY) (OTCQX: BABYF) has provided a bi-weekly default status report following a Management Cease Trade Order (MCTO) granted by the British Columbia Securities Commission. The MCTO was issued due to delays in completing audit procedures for the company's 2024 annual financial statements. The order restricts trading by the CEO and CFO but does not affect other shareholders.

The company confirms no material changes since the initial MCTO announcement on April 1, 2025, and is working with auditors to complete the financial statements. Else Nutrition expects to file its Annual Filings, including MD&A and AIF, by May 27, 2025, with a final deadline of May 30, 2025.

Else Nutrition Holdings has provided a bi-weekly default status report following the Management Cease Trade Order (MCTO) granted by the British Columbia Securities Commission. The MCTO was issued due to delays in completing audit procedures for the company's annual financial statements for the year ended December 31, 2024.

The MCTO restricts trading activities for the company's CEO and CFO until the Annual Filings are submitted and the order is lifted. Other shareholders maintain their ability to trade securities. The company confirms there have been no material changes since the initial MCTO announcement on April 1, 2025.

Else Nutrition is actively working with auditors to complete the financial statements audit and expects to file the required documents by May 13, with a final deadline of May 30, 2025. The company will continue to provide updates in accordance with National Policy 12-203 guidelines.

Else Nutrition Holdings Inc. (TSX: BABY) (OTCQX: BABYF) has launched 'Formula for Change,' a campaign to accelerate U.S. regulatory support for clinical trials of its dairy-free, soy-free infant formula. The initiative builds on Operation Stork Speed, a federal effort to fast-track next-generation infant formula development.

The company has developed the world's first infant formula based on whole plant ingredients, including almonds and buckwheat, which mirrors human milk's nutritional profile and holds the Clean Label Project Purity Award. While available internationally, U.S. regulations currently prevent clinical trials required for approval.

Key campaign objectives include:

• Modernizing outdated U.S. regulatory pathways
• Addressing market concentration dominated by four companies
• Providing alternatives for babies intolerant to dairy/soy
• Creating solutions following the 2022-2023 formula shortage crisis