Mr. Chris Jackson reports

DOSEOLOGY ENGAGES MCKINNEY REGULATORY SCIENCE ADVISORS TO ADVANCE INNOVATIVE ORAL POUCH PRODUCT DEVELOPMENT THROUGH SCIENCE AND REGULATORY EXPERTISE

Doseology Sciences Inc. has formed a strategic partnership with McKinney Regulatory Science Advisors, a premier FDA (Food and Drug Administration) regulatory consulting firm specializing in nicotine and reduced-risk consumer products, to spearhead its regulatory submission strategy and solidify its commitment to scientific leadership in the oral pouch technology space.

This collaboration marks a pivotal advancement for Doseology, transitioning the company toward regulatory execution and commercial readiness. McKinney's comprehensive guidance will encompass formulation strategy, data generation, Pre-market Tobacco Product Application (PMTA) preparation and postmarket compliance. The aim is to position Doseology as a frontrunner in delivering differentiated, IP and/or trade secret protected oral pouch products to regulated markets with confidence.

"Doseology is committed to leading with science and innovation in the oral pouch category. Engaging McKinney, a leader in regulatory science, ensures that our product development is not only innovative but also strategically aligned with regulatory expectations," said Tim Corkum, president and chief operating officer of Doseology. "This partnership underscores our dedication to building a defensible, regulatory-ready platform that prioritizes dose consistency and consumer safety."

"At McKinney Regulatory Science Advisors, we value working with organizations that apply a rigorous, science-based approach to product development and evaluation. Doseology's team has demonstrated a strong understanding of the role of regulatory science in identifying, characterizing and managing product risks. We look forward to a collaborative partnership that will support the advancement of Doseology's product portfolio," said Dr. Willie McKinney, chief executive officer of McKinney Regulatory Science Advisors.

Key highlights of the partnership:

• Accelerated regulatory pathway: McKinney's expertise is expected to expedite Doseology's navigation of FDA requirements, with the objective of streamlining development timelines and reducing regulatory uncertainty.
• Enhanced product design and IP protection: The collaboration is expected to strengthen Doseology's intellectual property by aligning formulation and testing strategies with regulatory standards, ensuring dose consistency, delivery performance and stability.
• Comprehensive PMTA readiness: McKinney will provide structured preparation for PMTA submissions, covering both nicotine and innovative nicotine-analogue formulations.
• Integrated R&D and manufacturing: McKinney will integrate its regulatory road map into Doseology's R&D program and manufacturing validation plans, ensuring formulation objectives, analytical testing, and quality systems align with regulatory expectations from the outset.
• Commitment to consumer safety: This partnership underscores Doseology's commitment to developing safe, effective and transparently supported products, with McKinney's counsel helping prioritize the right studies and documentation.

McKinney's scope of engagement

As part of the engagement, McKinney has agreed to:

• Conduct a regulatory landscape assessment for stimulant, nicotine and nicotine-alternative pouch formats across relevant jurisdictions;
• Define specific data and testing requirements to support anticipated claims and submissions;
• Advise on labelling, claims language and packaging compliance;
• Develop a presubmission engagement plan with regulators and draft submission materials;
• Recommend a postmarket surveillance framework and adverse event reporting processes.

About Doseology Sciences Inc.

Doseology Sciences is a biotechnology-driven consumer products company developing IP-backed oral stimulant technologies designed for cleaner profiles, precise delivery and performance-focused functionality. Anchored by a commitment to rigorous scientific research and advanced formulation technologies, Doseology is dedicated to leading the industry in creating breakthrough oral stimulant products with meaningful consumer benefits. Doseology is focused on building long-term enterprise value through innovation, regulatory alignment and the commercialization of differentiated stimulant products.

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