Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment

Rhea-AI Summary

Lifecore Biomedical (NASDAQ: LFCR) has been selected by Nirsum Laboratories to provide CDMO services for their lead candidate NRS-033, a novel treatment for opioid and alcohol use disorders entering Phase 2 clinical development.

The agreement encompasses assessment and technology transfer of fill and finish processes for NRS-033, leveraging Lifecore's expertise in sterile injectable pharmaceuticals. Lifecore will provide filled syringes for clinical development, with potential to create a comprehensive development and commercialization plan for the entire fill and finish process.

Positive

• New CDMO service agreement with Nirsum Labs for Phase 2 clinical trial product
• Potential for expanded scope into full development and commercialization plan
• Strategic entry into opioid and alcohol use disorder treatment market

Negative

• None.

Insights

Biotech Manufacturing Analyst

This CDMO service agreement for Nirsum's NRS-033 represents a strategically important win for Lifecore Biomedical in the specialized sterile injectable manufacturing space. The collaboration focuses on tech transfer, process assessment and method validation for fill-finish operations - core competencies where Lifecore has established expertise.

The deal's significance lies in its potential to evolve into a long-term commercial manufacturing partnership if NRS-033 succeeds in clinical trials. With opioid use disorder affecting over 3 million Americans, a successful therapeutic could translate into substantial manufacturing volumes. Lifecore's current market cap of $254M suggests significant upside potential from securing such commercial-scale production contracts.

For context, standard CDMO contracts for clinical-stage biologics typically generate $2-5M in annual revenue during development phases, with potential to scale to $20-50M annually if the drug reaches commercialization. While early-stage, this agreement strengthens Lifecore's position in the high-margin, specialized injectable CDMO market segment.

Clinical Research Analyst

The selection of Lifecore for NRS-033's clinical manufacturing represents more than just a service agreement - it's a strategic positioning in the rapidly evolving addiction treatment landscape. The key differentiator for NRS-033 lies in addressing the critical challenge of therapeutic retention, a major limitation of current OUD/AUD treatments.

From a market perspective, the therapeutic area is compelling:

• Current OUD market size exceeds $4B annually
• competition with few FDA-approved options
• High relapse rates with existing treatments create clear market opportunity

The NIH funding backing this program adds credibility to NRS-033's potential, while Lifecore's specialized capabilities in complex sterile injectables align perfectly with the product's requirements. This positions Lifecore advantageously for potential expanded collaboration through commercialization phases.

Development Services Span Tech Transfer, Process Assessment and Method Validation for Fill and Finish of NRS-033 for Planned Phase 2 Trial

Lifecore to Leverage Differentiated Capabilities and Knowledge in Fill and Finish to Support Nirsum’s NIH-Funded NRS-033 Development Program

CHASKA, Minn., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract development and manufacturing organization (“CDMO”), today announced that it has been selected by Nirsum Laboratories, Inc. (“Nirsum”) to provide CDMO services focused on supporting Nirsum’s clinical development of its lead development candidate, NRS-033. The activities to be conducted under the agreement include the assessment and technology transfer of the fill and finish process for NRS-033. These assessments will rely upon Lifecore’s differentiated expertise in the fill and finish of sterile injectable pharmaceutical products, potentially allowing Lifecore to create an overarching development and commercialization plan for the entire fill and finish process for NRS-033.

NRS-033 is a novel treatment for opioid use disorder (OUD) and alcohol use disorder (AUD). NRS-033, which is wholly owned and internally discovered by Nirsum, is currently entering Phase 2 clinical development. The newly signed agreement will position Lifecore to provide Nirsum with filled syringes for use in clinical development of NRS-033.

“With growing concerns about opioid and alcohol addiction in the U.S. and beyond, we’re grateful for the opportunity to support Nirsum on this important and promising treatment. Our agreement will enable Lifecore to apply our experience with complex formulations to the assessment, enhancement and validation of the fill and finish process for NRS-033,” said Paul Josephs, chief executive officer of Lifecore. “We are excited to add Nirsum to our growing list of customers and appreciative that their team has entrusted us to collaborate with them on these activities.”

“We believe that opioid and alcohol use disorders are enormous unmet needs, each with just a few decades-old, FDA-approved treatment options available. We believe NRS-033 will be a key innovation, solving the critical problem of short therapeutic retention of available therapies that results in high relapse rates for abstinence-seeking patients with OUD and AUD. By improving therapeutic retention with NRS-033, Nirsum aims to give hope to the millions of Americans with OUD and AUD,” said Nikej Shah, M.D., chief executive officer of Nirsum Labs. “We are excited to begin our work with Lifecore to potentially help bring our important therapy through further clinical development and commercialization.”

About Lifecore Biomedical

Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories to bring their innovations to market. For more information about the company, visit Lifecore’s website at www.lifecore.com.

About Nirsum Labs

Nirsum Laboratories, Inc. is a development stage biotechnology company committed to making addiction curable. Nirsum is developing NRS-033 in OUD and AUD, which are high unmet needs with pressing public health urgency. NRS-033’s development is funded in part through a Cooperative Agreement with the United States National Institutes of Health (HEAL Initiative award UH3DA048234 and U01DA061643).  For more information about the company, visit Nirsum’s website at www.nirsum.com.

Important Cautions Regarding Forward-Looking Statements

This press release contains forward-looking statements regarding future events and our future results that are subject to the safe harbor created under the Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act of 1933 and the Securities Exchange Act of 1934. Words such as “anticipate”, “estimate”, “expect”, “project”, “plan”, “intend”, “believe”, “may”, “might”, “will”, “should”, “can have”, “likely” and similar expressions are used to identify forward-looking statements. In addition, all statements regarding our anticipated future operating and financial expectations, customer opportunities and relationships, and potential market size or opportunities for customer products are forward-looking statements. All forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially, including such factors among others, as the company’s ability to successfully enact its business strategies, including with respect to installation, capacity generation and its ability to attract demand for its services, and its ability expand its relationship with its existing customers or attract new customers; the scope or anticipated markets for any products to be manufactured by Lifecore, the abiltiy for customers to obtain regulatory approvals on their anticipated timing, or at all, the nature of the competitive landscape for us or our customers, the impact of inflation on Lifecore’s business and financial condition; changes in business conditions and general economic conditions both domestically and globally, including rising interest rates and fluctuation in foreign currency exchange rates; Lifecore’s ability to access sufficient capital to fund its business strategies; and other risk factors set forth from time to time in Lifecore’s SEC filings, including, but not limited to, the Annual Report on Form 10-K for the year ended May 26, 2024 (the “2024 10-K”). For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to our filings with the Securities and Exchange Commission, including the risk factors contained in the 2024 10-K. Forward-looking statements represent management’s current expectations as of the date hereof and are inherently uncertain. Except as required by law, we do not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.

FAQ

What is the scope of Lifecore's (LFCR) new CDMO agreement with Nirsum Labs?

Lifecore will provide CDMO services including assessment and technology transfer of fill and finish processes for NRS-033, supplying filled syringes for Phase 2 clinical trials.

What therapeutic areas will LFCR's manufacturing services target through the Nirsum partnership?

The services will support NRS-033, a treatment for opioid use disorder (OUD) and alcohol use disorder (AUD).

What stage of development is Nirsum's NRS-033 product that LFCR will manufacture?

NRS-033 is entering Phase 2 clinical development.

What specific manufacturing capabilities will LFCR provide for Nirsum's NRS-033?

Lifecore will provide expertise in fill and finish of sterile injectable pharmaceuticals, including process assessment, technology transfer, and method validation.

What is the potential long-term scope of LFCR's partnership with Nirsum?

The partnership could expand to include creating an overarching development and commercialization plan for the entire fill and finish process of NRS-033.