MARKET WIRE NEWS

MitoCareX Bio Reports Successful Results in Vitro: MITOLINE(TM)-Powered Small Molecules Show Anti-Inflammatory Potential for Metabolic Syndrome-Related Diseases

MWN-AI** Summary

N2OFF, Inc. (NASDAQ: NITO) recently announced promising in vitro results from its subsidiary, MitoCareX Bio Ltd., showcasing the potential of MITOLINE™-powered small molecules to combat inflammation related to metabolic syndrome diseases. This innovative approach targets human mitochondrial carriers—key components in cellular energy production—using a proprietary discovery platform that offers unique models for drug development.

The preliminary data indicate that selected small molecule candidates effectively inhibit pro-inflammatory responses in human immune cells, suggesting that mitochondrial carrier modulation could provide significant anti-inflammatory benefits. These findings lay the groundwork for further validation and optimization, aiming to address various inflammatory metabolic diseases such as diabetes, which currently represent a burgeoning therapeutic market projected to exceed $120 billion by 2030.

The global market for anti-inflammatory drugs is also set for substantial growth, anticipated to escalate from $122 billion in 2024 to nearly $275 billion by 2034, driven by rising demand for targeted oral therapies. Small-molecule immunomodulators specifically are expected to increase from approximately $188 billion in 2025 to more than $350 billion by 2035.

MitoCareX's MITOLINE™ algorithm addresses a critical barrier in mitochondrial drug discovery by generating reliable 3D models of mitochondrial carrier proteins. This advancement facilitates the rapid identification of novel small-molecule scaffolds capable of modulating mitochondrial functions implicated in various diseases.

As MitoCareX Bio pushes forward to pre-clinical studies for its most promising candidates, it aims to not only develop innovative treatments for metabolic disorders but also expand its discovery platform across a broader range of mitochondrial targets. This strategic direction places MitoCareX Bio at the forefront of addressing the growing need for effective therapies in inflammatory metabolic diseases.

MWN-AI** Analysis

MitoCareX Bio's recent in vitro results mark a significant breakthrough in the development of therapies targeting inflammatory metabolic diseases, which represents a burgeoning market projected to exceed $120 billion by 2030. The efficacy of its MITOLINE™ algorithm in identifying small molecules that modulate mitochondrial carriers presents a compelling investment opportunity, particularly as inflammation-related conditions continue to gain prevalence.

The global market for anti-inflammatory drugs is poised for substantial growth, anticipated to expand from approximately $122 billion in 2024 to nearly $275 billion by 2034, indicating a robust CAGR of ~8.4%. Similarly, the small-molecule immunomodulators segment is set to flourish, projected to soar from around $188 billion in 2025 to over $350 billion by 2035. These trends are underscored by an increasing demand for targeted, oral therapies that offer distinct advantages over traditional treatments.

From an investment standpoint, N2OFF Inc.'s strategic focus on MitoCareX, in conjunction with its renewable energy ventures, positions it favorably within two high-growth sectors. The potential to leverage MITOLINE™ for novel drug discovery addresses a critical gap in the market, enhancing its competitive edge against established players.

However, prospective investors should remain cognizant of inherent risks associated with pharmaceutical development, including the lengthy regulatory process and the requirement for successful clinical trial outcomes. N2OFF's emphasis on further validating its candidates through in vivo studies and its ongoing commitment to expanding its discovery engine suggest a proactive approach to risk management.

In summary, given MitoCareX Bio's promising preliminary results and the expansive market potential for its therapeutic targets, investors should consider engaging with N2OFF as a strategic entry point into the dynamic bio-pharmaceutical landscape.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

MITOLINEAlgorithm Powers Development of First-in-Class Small Molecules Targeting a Mitochondrial Carrier for Inflammatory Metabolic Diseases – A Market Projected to Exceed $120 billion by 2030

Neve Yarak, Israel, Feb. 12, 2026 (GLOBE NEWSWIRE) -- N2OFF, Inc. (NASDAQ: NITO) (“N2OFF” and the “Company”), a drug discovery company that is also investing in solar energy assets based on the RTB (Ready to Build) business model, recently announced that MitoCareX Bio Ltd. (“MitoCareX Bio”), a specialty biotechnology company developing small?molecule drugs that target human mitochondrial carriers, its wholly- owned subsidiary, has shown preliminary in vitro data demonstrating inhibition of pro?inflammatory responses in human immune cells using its proprietary discovery platform.

Using MITOLINE?derived models, MitoCareX has assembled a focused library of small?molecule candidates that is now being evaluated in a suite of proprietary in-vitro assays designed to capture mitochondrial function, inflammatory signalling, and metabolic readouts. The newly reported in vitro data show that selected candidates reduce key inflammatory markers in human immune cells, providing MitoCareX Bio with an initial line of evidence that mitochondrial carrier modulation can deliver anti?inflammatory benefit in human?relevant systems. These results support further in vivo validation and lead optimization across multiple inflammatory metabolic disease indications including diseases related to the metabolic syndrome.

Inflammatory and inflammatory metabolic diseases represent one of the fastest?growing therapeutic areas in global pharma, with anti?inflammatory drugs expected to grow from approximately $122 billion in 2024 to nearly $275 billion by 2034 (CAGR ~8.4%). Within this landscape, small?molecule immunomodulators alone are projected to expand from around $188 billion in 2025 to more than $350 billion by 2035 (CAGR ~6.5%), underscoring strong and sustained demand for oral, targeted anti?inflammatory therapies. Metabolic disorder therapeutics, which include key inflammatory metabolic diseases such as diabetes and related syndromes, are estimated around $77 billion in 2024 and forecast to surpass $120 billion by 2030.

MitoCareX’s cutting?edge MITOLINE algorithm overcomes a critical bottleneck in mitochondrial drug discovery: the lack of solved 3D structures for most human mitochondrial carriers. MITOLINE applies advanced sequence based analyses to enable reliable 3D comparative models of mitochondrial carrier proteins, allowing MitoCareX to characterize substrate translocation binding sites for its virtual screening campaigns. This platform supports rapid identification of novel small?molecule scaffolds that engage mitochondrial carriers implicated in oncology, autoimmune, and metabolic?inflammatory diseases.

MitoCareX Bio plans to advance its most promising mitochondrial?targeted anti?inflammatory candidates toward pre-clinical studies, while continuing to broaden the MITOLINE?powered discovery engine across additional mitochondrial carrier targets.

About N2OFF Inc:

N2OFF owns 100% of MitoCareX Bio Ltd, a drug discovery company engaged in targeting cancer therapeutics and other diseases through the mitochondrial SLC25 protein family. Additionally, N2OFF adopted an investment strategy focused on European renewable energy assets utilizing a RTB (Ready to Build) business model. The Company is currently the lead investor in four solar projects across three European Union countries, all introduced by Solterra Renewable Energy Ltd., a wholly owned subsidiary of Solterra Energy Ltd.

N2OFF also controls approximately 98% of Save Foods Ltd., an Israeli company focused on post-harvest treatment technologies designed to reduce pathogen contamination in fruits and vegetables.

For more information, please visit www.n2off.com.

Forward-looking Statements:

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the expected growth of global anti-inflammatory drugs market, the small molecule immunomodulators market and the global metabolic disorder therapeutics market and how MitoCareX Bio plans to advance its most promising mitochondrial?targeted anti?inflammatory candidates toward pre-clinical studies, while continuing to broaden the MITOLINE™?powered discovery engine across additional mitochondrial carrier targets. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause N2OFF’s and its subsidiaries’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our market and other conditions, history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to not satisfying the continued listing requirements of Nasdaq Capital Market; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of N2OFF’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 31, 2025 and other public reports filed with the SEC. Except as otherwise required by law, we undertake no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. We are not responsible for the contents of third-party websites.

Investor Relations Contact:
Michal Efraty
michal@efraty.com


FAQ**

How does N2OFF Inc. NITO plan to utilize the MITOLINE™ algorithm to differentiate its offerings in the rapidly expanding market for small-molecule immunomodulators targeting mitochondrial carriers?

N2OFF Inc. (NITO) plans to leverage the MITOLINE™ algorithm to optimize the design and efficacy of its small-molecule immunomodulators by precisely targeting mitochondrial carriers, thereby differentiating its product offerings in the competitive biopharmaceutical market.

What strategies does N2OFF Inc. NITO have in place to manage risks associated with advancing its mitochondrial-targeted anti-inflammatory candidates toward pre-clinical studies?

N2OFF Inc. employs a combination of rigorous pre-clinical testing, strategic partnerships, and adaptive project management to mitigate risks associated with the development of its mitochondrial-targeted anti-inflammatory candidates.

Can N2OFF Inc. NITO provide further details on the timeline for initiating clinical trials for the small molecules being developed by MitoCareX Bio and how they intend to secure necessary regulatory approvals?

N2OFF Inc. (NITO) is expected to release more information on the clinical trial timeline for the small molecules developed by MitoCareX Bio and their strategy for obtaining regulatory approvals in upcoming press releases and investor meetings.

How does N2OFF Inc. NITO's investment in solar energy assets align with its core focus on drug discovery, and what impact might this dual strategy have on its overall financial health?

N2OFF Inc.'s investment in solar energy assets diversifies its portfolio, potentially stabilizing cash flow and enhancing financial resilience while allowing it to fund its core drug discovery initiatives, fostering sustainable growth through innovative revenue streams.

**MWN-AI FAQ is based on asking OpenAI questions about N2OFF Inc. (NASDAQ: NITO).

N2OFF Inc.

NASDAQ: NITO

NITO Trading

25.83% G/L:

$1.12 Last:

900,589 Volume:

$0.945 Open:

mwn-link-x Ad 300

NITO Latest News

NITO Stock Data

$2,767,141
1,460,345
N/A
4
N/A
Agriculture
Materials
US
Neve Yarak

Subscribe to Our Newsletter

Link Market Wire News to Your X Account

Download The Market Wire News App