Fifty1 Labs, Inc. Leadership Publishes Landmark Framework to Unlock Global Oncology Data Through AI-Driven Real-World Evidence

Leadership Team's Technical Primer Enhances Real-World Evidence (RWE) for Cross-Border Impact, Positioning Fifty1 AI Labs in a $48B Market Opportunity

VANCOUVER, British Columbia, Sept. 04, 2025 (GLOBE NEWSWIRE) -- via IBN – Fifty1 AI Labs, a subsidiary of Fifty1 Labs, Inc. (OTC: FITY), announces the publication of a landmark technical primer on "transportability" methods in oncology real-world evidence (RWE). Authored by CTO Alind Gupta and CEO Paul Arora, the primer, published in the Journal of Comparative Effectiveness Research (https://becarispublishing.com/doi/10.57264/cer-2025-0041)— showcases the company's leadership at the intersection of advanced statistics, AI, and oncology data.

This breakthrough positions Fifty1 AI Labs at the forefront of the rapidly growing oncology RWE market, projected to expand from $789 million in 2024 to $3.51 billion by 2035, at a CAGR of 14.7%. By integrating advanced statistical and AI-driven transportability frameworks, the company is unlocking new possibilities for drug repurposing and accelerating access to life-saving therapies, particularly in rare diseases and underserved regions.

The framework defines how transportability methods make RWE actionable across borders, empowering health technology assessments (HTAs) and accelerating patient access to life-saving therapies worldwide. By bridging data gaps, particularly in rare diseases and underserved regions, this work demonstrates both practical analytics and meaningful patient impact.

Setting a Global Standard for RWE

The primer translates complex transportability principles—Consistency, Positivity, and Conditional Exchangeability—into accessible "golden rules" for trustworthy, cross-border evidence sharing. By simplifying technical concepts into practical guidance, Fifty1 AI Labs is establishing global standards for how oncology data can be adapted and applied internationally.

These principles ensure that non-local RWE can be reliably adapted to local contexts, addressing critical evidence gaps where local data is limited. By employing advanced analytics techniques such as matching, weighting, standardization, and quantitative bias analysis, Fifty1 AI Labs enhances the reliability of oncology data for HTAs and regulatory bodies, driving faster and more informed decision-making.

"Our AI-driven platform, guided by CTO Alind Gupta's technical expertise, integrates these transportability frameworks to unlock new oncology indications from vast global datasets," said Paul Arora, CEO of Fifty1 Labs, Inc. "This work not only accelerates access to innovative therapies but also positions Fifty1 AI Labs as a leader in a high-growth market, delivering significant value for patients, partners, and shareholders."

A High-Growth Market Opportunity

The global RWE solutions market is projected to soar from $17.9 billion in 2024 to $48 billion by 2032, at a CAGR of 13.3% (Fortune Business Insights, 2025). Fifty1 AI Labs' transportability framework taps into this momentum, offering scalable solutions that extend beyond oncology and signal strong potential for investor ROI. By repurposing safe, off-patent compounds through its AI-driven platform, the company is redefining drug discovery, reducing costs, and creating lasting value for stakeholders.

Practical Impact for Patients and Investors

The primer's transportability methods empower Fifty1 AI Labs to adapt non-local oncology data to meet local regulatory needs, accelerating patient access to therapies in regions with sparse data. This approach is particularly impactful for rare diseases, where robust evidence is often scarce. For investors, this underscores Fifty1 AI Labs' ability to deliver innovative, scalable solutions in a high-demand sector, driving both clinical and financial outcomes.

About Fifty1 AI Labs

Fifty1 AI Labs, a subsidiary of Fifty1 Labs, Inc. (OTC: FITY), is revolutionizing drug discovery by leveraging AI to unlock new potential in proven medicines. By repurposing safe, off-patent compounds, we accelerate smarter therapies that improve lives, reduce costs, and create lasting value for patients, partners, and forward-thinking investors.

Contact:
Investor Relations
Fifty1 Labs, Inc.
ir@fifty1labs.com | (877) 505-5006
www.fifty1AIlabs.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding the potential impact, development, and timeline of AI-powered drug repurposing, the scalability of transportability frameworks, and the ability of Fifty1 AI Labs' platform to transform oncology and global health outcomes, are forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that may cause the company's actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the success and timing of partnerships and projects, the efficacy and safety of repurposed treatments, regulatory approvals, and the company's ability to successfully develop and commercialize its technologies. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, please refer to Fifty1 Labs, Inc.'s filings with the OTC Markets. The company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

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