American Marconi Wireless News - LIR Life Sciences Signs Development Services Agreement with Oxygen Handel GmbH (OH) to Advance Regulatory and Preclinical Roadmap for Transdermal Obesity Pipeline

Under the agreement, OH will conduct an FDA-focused regulatory and development roadmap designed to evaluate the optimal approval pathway for LIR's transdermal GLP-1 and GLP/GIP-based therapeutic candidates, including assessment of potential 505(b)(2) regulatory pathways, bridging strategies to existing approved molecules, formulation development requirements, and preclinical and clinical study sequencing. The engagement is intended to generate a comprehensive development plan, including study mapping, regulatory milestones, risk analysis, and budget forecasting. The roadmap is further intended to establish a structured development framework for LIR's expanding transdermal pipeline, including current and future obesity and metabolic disease candidates.

LIR believes establishing a formalized translational and regulatory pathway at this stage has the potential to improve development efficiency, reduce execution risk, and support more focused capital allocation as it advances its needle-free transdermal delivery platform.

"This agreement is an important operational milestone for us," said Edward Mills, Chief Executive Officer of LIR Life Sciences. "As our pipeline continues to expand beyond individual molecules into a broader transdermal delivery platform, it becomes increasingly important to establish a clear and efficient regulatory and preclinical roadmap. We view this as the foundation for systematic advancement of multiple product candidates."

The initial Phase 0 engagement is expected to include regulatory pathway analysis, target product profile development, gap assessment for formulation and nonclinical requirements, and construction of a program-level development timeline to support future regulatory engagement and commercialization planning.

About LIR Life Sciences Corp.

LIR Life Sciences is focused on researching and developing scalable and affordable treatments for obesity using novel drug delivery methods. The company is advancing a transdermal patch and other novel delivery systems that mimic GLP-1, a naturally occurring hormone that helps regulate appetite and blood sugar. These therapies could potentially offer an alternative to injectable drugs. The goal is to improve access, adherence, and cost-efficiency in both developed and emerging markets. LIR Life Sciences aims to address the global burden of obesity with practical solutions based on established compounds and proven science.

ON BEHALF OF LIR LIFE SCIENCES CORP.,

"Dr. Edward Mills,"

Chief Executive Officer

For more information, please contact:

Dr. Edward Mills
Chief Executive Officer
Tel: +1 888 436 7772
Email: [email protected]

Neither the CSE nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Cautionary Note Regarding Forward-Looking Information

This news release contains certain statements and information that may constitute "forward-looking information" within the meaning of applicable securities legislation. Such forward-looking information is based on the current expectations, estimates, projections, beliefs, assumptions and views of management as of the date hereof. Forward-looking information is often, but not always, identified by words such as "believe", "project", "aim", "expect", "anticipate", "estimate", "intend", "strategy", "future", "opportunity", "plan", "may", "should", "will", "would", "potential", "continue" and similar expressions.

In this news release, forward-looking information includes, without limitation, statements regarding: the expected scope, timing and outcomes of the Company's engagement with Oxygen Handel GmbH; the evaluation and potential availability of regulatory pathways, including any 505(b)(2) pathway or bridging strategy; the development of the Company's transdermal GLP-1 and GLP/GIP-based therapeutic candidates; anticipated formulation, preclinical and clinical development activities; future regulatory interactions and milestones; the potential commercial viability, scalability and market acceptance of the Company's transdermal delivery platform; the advancement of current and future obesity and metabolic disease product candidates; the anticipated benefits of development planning and capital allocation initiatives; and the Company's broader business objectives, growth strategy and financial prospects.

Forward-looking information is necessarily based on a number of assumptions that management considers reasonable as of the date hereof, including assumptions regarding: the Company's ability to execute its development plans; the availability of adequate financing on acceptable terms; the successful completion of research, formulation development, preclinical studies and clinical trials; the ability to obtain required regulatory guidance, approvals and clearances; the continued availability of key personnel, consultants, suppliers and strategic partners; the applicability of existing scientific data and regulatory frameworks; and general economic, market, industry and business conditions. There can be no assurance that such assumptions will prove to be accurate.

Although the Company believes that the expectations reflected in the forward-looking information are reasonable, no assurance can be given that such expectations will prove to be correct, and readers are cautioned not to place undue reliance on forward-looking information. The forward-looking information contained in this news release is expressly qualified in its entirety by this cautionary statement and is made as of the date hereof. The Company undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law.

SOURCE: Lir Life Sciences Corp.

View the original press release on ACCESS Newswire

G.Stevens--AMWN