Fifty1 AI Labs' REVIVE Clinical Trial Redefines Long COVID Treatment, Pioneering AI-Driven Therapies and Propelling Fifty 1 Labs, Inc. Toward $50M Valuation and Global Biotech Leadership

Rhea-AI Summary

Fifty1 AI Labs (OTC: FITY) has successfully completed the REVIVE Phase III clinical trial for Long COVID treatment, marking a significant breakthrough in AI-driven drug repurposing. The trial, conducted in collaboration with prestigious institutions including Stanford and Duke University, enrolled over 600 participants globally and represents the largest Long COVID study to date.

The company aims to achieve a $50 million valuation while targeting the $320.6 billion functional medicine market. The trial's success is powered by Fifty1's proprietary Bayesian and Predictive Platform, developed through a $1 million R&D investment. The company plans to uplist to OTCQB by Q1 2026 and eventually to NASDAQ, with upcoming product launches and a virtual shareholder teleconference scheduled for July 28, 2025.

Positive

• Successful completion of Phase III REVIVE trial - the largest Long COVID study to date with 600+ participants
• Strategic positioning in $320.6B functional medicine market with 13.8% CAGR
• $1M R&D investment in proprietary AI platform showing successful results
• Clear uplisting strategy to OTCQB (Q1 2026) and NASDAQ
• Planned strategic acquisitions in $5-10M range to enhance R&D capabilities

Negative

• Currently trading on OTC markets, indicating higher risk profile
• Significant capital requirements needed for planned acquisitions and R&D expansion
• Trial results still under peer review, pending final validation
• Website and product offerings not yet launched, indicating early-stage development

Pioneering a New Era in Healthcare: AI-Driven Innovation Unlocks Transformative Therapies and Drives Path to $50M Valuation

SEATTLE, July 10, 2025 (GLOBE NEWSWIRE) -- via IBN -- Fifty1 AI Labs, LLC, a wholly owned subsidiary of Fifty 1 Labs, Inc. (OTC: FITY), in collaboration with premier academic institutions including Stanford University, Duke University, McMaster University (Canada), and global partners, proudly announces the successful completion of the REVIVE Adaptive Platform Trial (NCT06128967). This historic Phase III, multicenter, adaptive, randomized, double-blind, placebo-controlled trial, the largest and most rigorous Long COVID study to date, marks a pivotal milestone in addressing a global health crisis affecting approximately 400 million people and 15% of COVID-19 survivors, with an estimated economic burden exceeding USD 1 trillion, annually. Powered by Fifty1 AI Labs' proprietary AI platform and aligned with Fifty 1 Labs, Inc.'s ambitious Game Plan to lead the $320.6 billion functional medicine market and achieve a $50 million valuation, the REVIVE Trial positions the company as a trailblazer in AI-driven drug repurposing and precision medicine, delivering transformative therapies and substantial shareholder value.

A Landmark Achievement in Long COVID Research and Functional Medicine

The REVIVE Trial is the first adaptive platform trial to demonstrate a clear treatment benefit for Long COVID, leveraging repurposed medicines to address this debilitating condition. This breakthrough aligns seamlessly with Fifty 1 Labs, Inc.'s vision to revolutionize healthcare through AI-driven drug repurposing and functional medicine, targeting high-growth areas like preventative healthcare within the $5.68 trillion biotech market (CAGR 13.8%, Precedence Research). By addressing Long COVID's complex symptoms through innovative, data-driven therapies, Fifty1 AI Labs is advancing personalized medicine, a sector projected to reach $900 billion by 2030 (Statista). This milestone reinforces Fifty 1 Labs, Inc.'s strategic roadmap to capture significant market share and drive exponential growth, enhancing investor confidence and positioning the company for uplisting to the OTCQB by Q1 2026 and the NASDAQ Capital Market in the coming years.

Unprecedented Scale, Speed, and Scientific Excellence

As the largest completed Long COVID trial, REVIVE enrolled over 600 participants across multiple global sites, achieving the fastest recruitment of any study of its kind. This feat was made possible through Fifty1 AI Labs' operational excellence and strategic partnerships with world-class institutions, guided by the company's elite management team. The trial's rigorous execution and robust data collection underscore Fifty 1 Labs, Inc.'s commitment to scientific excellence and operational efficiency, key pillars of its Game Plan to enhance shareholder visibility and liquidity through uplisting and strategic growth initiatives.

Powered by Fifty1 AI Labs' Cutting-Edge AI Platform

The REVIVE Trial's success is driven by Fifty1 AI Labs' proprietary Bayesian and Predictive Platform, a cornerstone of Fifty 1 Labs, Inc.'s $1,000,000 R&D investment in its Delaware-based subsidiary. This state-of-the-art AI platform integrates clinical trial data, patient outcomes, drug interaction profiles, and patent analytics to optimize drug candidate selection and enable a seamless adaptive trial design. By leveraging advanced Bayesian analytics, the platform accelerated the identification of effective treatments, reduced trial timelines, and lowered costs, setting a new standard for clinical research efficiency. This technological edge not only positions Fifty1 AI Labs as a leader in AI-driven drug repurposing but also supports Fifty 1 Labs, Inc.'s broader vision to deliver personalized, data-driven solutions across functional medicine, enhancing shareholder value through innovation and scalability.

Catalyzing Transformative Therapies and Intellectual Property Growth

The REVIVE Trial's findings, currently under peer review at a leading medical journal, establish a foundation for polypharmacy-based treatment regimens using repurposed drugs delivered through innovative systems such as transdermal and sublingual formulations. These advancements unlock significant opportunities for intellectual property (IP) development, enabling Fifty 1 Labs, Inc. to build a robust portfolio of proprietary therapeutic platforms. By securing IP rights and developing commercially viable products, the company is poised to capture a substantial share of the Long COVID treatment market, projected to generate billions in annual revenue. This strategic focus on IP and commercialization aligns with Fifty 1 Labs, Inc.'s Game Plan to pursue strategic acquisitions in the $5-10 million range, further strengthening its R&D capabilities and market presence, and delivering long-term value to shareholders.

"The REVIVE Trial is a testament to our vision of transforming healthcare through AI-driven innovation," said Dr. Paul Arora, CEO of Fifty 1 Labs, Inc. "By leveraging Fifty1 AI Labs' cutting-edge platform and our world-class partnerships, we are delivering hope to millions affected by Long COVID while creating a scalable model for future breakthroughs in functional medicine. Our Game Plan positions FITY to lead the biotech industry, driving exponential growth and exceptional returns for our shareholders."

Strategic Outlook: A Roadmap for Global Leadership

The REVIVE Trial's success is a critical step in Fifty 1 Labs, Inc.'s Game Plan to achieve a $50 million valuation and lead the $320.6 billion functional medicine market. By integrating the trial's findings into its broader R&D strategy, the company is pursuing regulatory pathways to bring novel therapies to market, establishing R&D hubs in Vancouver, and forging strategic partnerships with pharmaceutical leaders. These initiatives, supported by the planned launch of a minimum viable product website by July 24, 2025, and a fully interactive website by July 31, 2025, at www.fifty1AIlabs.com, will enhance investor engagement and market visibility. The upcoming virtual shareholder teleconference on July 28, 2025, at 4:00 PM EST, hosted on X (@Fifty1Labs), will provide further insights into FITY's transformative vision and progress toward uplisting.

For More Information

To learn more about Fifty 1 Labs, Inc., Fifty1 AI Labs, LLC, or the REVIVE Trial, visit www.fifty1AIlabs.com or contact investorrelations@fifty1labs.com. Join us for the Virtual Shareholder Teleconference on X (@Fifty1Labs) on July 28, 2025, at 4:00 PM EST to hear directly from our leadership team.

About Fifty 1 Labs, Inc.

Fifty 1 Labs, Inc. (OTC: FITY), a Nevada-based biotech pioneer, is transforming healthcare through AI-driven drug repurposing and functional medicine. Through its subsidiaries, the company delivers innovative, data-driven solutions for preventative healthcare and performance nutrition. Committed to revolutionizing personalized medicine, Fifty 1 Labs is poised to lead the biotech and wellness industries, creating lasting value for shareholders through cutting-edge innovation and strategic growth.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the company's future financial and operating performance, business strategy, plans, objectives, and expectations regarding future events or performance. These statements are based on current expectations, estimates, forecasts, and projections, and involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. The company undertakes no obligation to update or revise any forward-looking statements, except as required by law. For additional details, refer to the company's filings with the Securities and Exchange Commission.

Contact:
Investor Relations
Fifty 1 Labs, Inc.
Email: ir@fifty1labs.com
Phone: (877) 505-5006
Website: www.fifty1AIlabs.com

FAQ

What are the key findings of Fifty1 AI Labs' (FITY) REVIVE clinical trial for Long COVID?

The REVIVE trial is the first adaptive platform trial to demonstrate clear treatment benefits for Long COVID using repurposed medicines. The Phase III trial involved over 600 participants across multiple global sites, though specific results are still under peer review.

What is Fifty1 AI Labs' (FITY) target valuation and market opportunity?

The company aims to achieve a $50 million valuation while targeting the $320.6 billion functional medicine market with a CAGR of 13.8%. They're focusing on the Long COVID treatment market, which affects approximately 400 million people globally.

When will Fifty1 AI Labs (FITY) uplist to major exchanges?

The company plans to uplist to the OTCQB by Q1 2026 and subsequently aims to list on the NASDAQ Capital Market in the coming years.

What is the upcoming catalyst timeline for Fifty1 AI Labs (FITY) stock?

Key upcoming catalysts include the launch of their MVP website by July 24, 2025, full interactive website by July 31, 2025, and a virtual shareholder teleconference on July 28, 2025 at 4:00 PM EST.

How much has Fifty1 AI Labs (FITY) invested in R&D?

The company has made a $1,000,000 R&D investment in its Delaware-based subsidiary, focusing on developing their proprietary Bayesian and Predictive Platform for AI-driven drug repurposing.