Biomerica Lands a $1.75 Million CDMO Master Services Agreement for IVD Diagnostic Development

Biomerica (Nasdaq: BMRA) signed a three-year, auto-renewing CDMO Master Services Agreement with a confidential life sciences partner to develop proprietary IVD assays.

Rhea-AI Summary

Biomerica (Nasdaq: BMRA) signed a three-year, auto-renewing CDMO Master Services Agreement with a confidential life sciences partner to develop proprietary IVD assays.

The engagement targets over $1.75 million in initial development fees, with milestone-based revenue, using Biomerica’s existing FDA-licensed, ISO 13485-certified Irvine facility and team.

Positive

• Initial contract development target fee of over $1.75 million across multiple SOWs
• Three-year Master Services Agreement with automatic one-year renewals
• Milestone-based revenue recognition tied to accepted SOW deliverables
• Work performed at FDA-licensed, ISO 13485-certified Irvine facility
• Capital-light use of existing staff, equipment, and infrastructure
• CDMO revenue stream alongside core inFoods IBS program

Negative

• None.

Argus May 28 session

-1.02% close to close 3.2x rel. volume Open Argus

Details

News Market Reaction – BMRA

On May 28, the day this news came out, BMRA closed 1.02% below the previous close. That session’s volume was 3.2x the stock’s average daily volume.

Data tracked by StockTitan Argus for the May 28 session.

Key Figures

Initial CDMO fee target: over $1.75 million MSA term: 3 years Company experience: over 40 years +5 more

Initial CDMO fee target

over $1.75 million

Initial contract development target fee under the new MSA

MSA term

3 years

Initial term for the Master Services Agreement before auto-renewals

Company experience

over 40 years

ELISA-based assay development expertise underpinning inFoods IBS and CDMO work

Q3 net sales

$0.99M

Third quarter fiscal 2026 net sales from prior earnings release

Q3 net loss

$1.31M

Third quarter fiscal 2026 net loss from prior earnings release

Latest quarterly net sales

$987,000

Net sales for quarter ended February 28, 2026 (10-Q)

Latest quarterly net loss

$1,312,000

Net loss for quarter ended February 28, 2026 (10-Q)

Cash balance

$1.34 million

Cash as of February 28, 2026 with going concern disclosure (10-Q)

Historical Context

5 past events · Latest: May 19

5 events

1. May 19

   Management change

   24h Move

   +5.8%

   Appointment of an experienced CFO to support financial and strategic scaling.

2. Apr 29

   Clinical data

   24h Move

   -0.9%

   Acceptance of inFoods IBS real-world data for presentation at DDW 2026.

3. Apr 16

   Reimbursement update

   24h Move

   +4.3%

   Medicare contractor confirms claim-by-claim review, enabling scalable billing.

4. Apr 14

   Market expansion

   24h Move

   +1.0%

   Launch of inFoods IBS in Canada via distribution and lab partners.

5. Apr 13

   Earnings results

   24h Move

   +1.0%

   Q3 FY2026 results showing revenue decline but progress on margins and CDMO focus.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

cdmo, master services agreement, in vitro diagnostic, ivd, +2 more

6 terms

cdmo financial

"reflecting the Company’s CDMO strategy as a capital-efficient, parallel revenue stream"

A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.

master services agreement financial

"today announced it has entered into a Master Services Agreement (MSA)"

A master services agreement is a standing contract that sets the main terms, responsibilities, pricing framework and processes for future work between two parties, allowing individual projects or orders to be added later without renegotiating core terms. For investors, it signals predictability and reduced legal friction around revenue streams and costs—like a subscription plan for services that makes future income and obligations easier to forecast and value.

in vitro diagnostic medical

"to develop proprietary in vitro diagnostic (IVD) assays"

In vitro diagnostics are tests, instruments and kits used to analyze samples taken from the body—such as blood, urine or swabs—outside the body (in a lab or cartridge) to detect disease, infections, genetic traits or other biological signs. Investors care because these products generate sales, recurring revenue from consumable test kits, and value that hinges on test accuracy, regulatory approvals and reimbursement policies; like a home pregnancy test but for many medical conditions.

ivd medical

"to develop proprietary in vitro diagnostic (IVD) assays"

IVD stands for in vitro diagnostic — tests, instruments and kits that analyze samples taken from the body (blood, saliva, tissue) outside the body, such as lab assays or home pregnancy tests. Investors watch IVDs because they drive recurring sales, depend on regulatory approval and insurance coverage to reach markets, and differences in accuracy, cost or availability can quickly affect a maker’s revenue and legal risk.

elisa medical

"expression of the same ELISA-based assay development expertise that underpins Biomerica’s own"

A laboratory test that detects specific proteins or antibodies in a sample by producing a measurable color or signal, similar to how a home pregnancy test shows a line when it finds a target substance. Investors care because ELISA results help determine whether a medical product works, meets regulatory standards, or can be manufactured reliably — factors that affect a company’s revenue potential, approval timelines, and risk profile.

iso 13485 regulatory

"Biomerica’s FDA-licensed, ISO 13485-certified facility in Irvine, California"

ISO 13485 is an international quality management standard for organizations that design, produce, or service medical devices. Think of it as a factory’s rulebook and checklist that helps ensure products are safe, consistently made, and meet regulatory rules worldwide. For investors, certification signals lower operational and regulatory risk, easier market access, and greater reliability of a company’s medical products and supply chain — similar to buying from a trusted, inspected supplier.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Auto-renewing Master Services Agreement engages Biomerica’s integrated development and manufacturing platform, reflecting the Company’s CDMO strategy as a capital-efficient, parallel revenue stream alongside its core inFoods® IBS program

IRVINE, Calif., May 28, 2026 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a developer and manufacturer of diagnostic test systems and CDMO services provider, today announced it has entered into a Master Services Agreement (MSA) with a confidential life sciences company to develop proprietary in vitro diagnostic (IVD) assays. The engagement carries an initial contract development target fee of over $1.75 million, to be earned across multiple Statements of Work (SOWs) under the MSA. Biomerica was chosen following a competitive evaluation in which multiple CDMO organizations were assessed.

The MSA establishes an initial three-year term with automatic one-year renewals. All development work will be performed at Biomerica’s FDA-licensed, ISO 13485-certified facility in Irvine, California. Revenue will be recognized on a milestone-completion basis as individual SOW deliverables are accepted.

CDMO STRATEGY AND REVENUE CONTEXT

This CDMO engagement is a direct expression of the same ELISA-based assay development expertise that underpins Biomerica’s own inFoods® IBS technology platform — using capabilities built and refined over more than 40 years. The Company is not pivoting from its core focus; rather, it is monetizing its established infrastructure and scientific capabilities in a capital-efficient, parallel revenue stream. inFoods® IBS remains Biomerica’s primary commercial priority.

The development work is designed to be completed by Biomerica’s existing team of research scientists using the Company’s existing equipment and infrastructure. This capital-light structure is expected to require minimal incremental costs, creating meaningful operating leverage as the CDMO program scales.

MANAGEMENT COMMENTARY

“Biomerica’s primary mission remains the commercialization of inFoods® IBS — a clinically validated, precision diagnostic that we believe has the potential to transform how IBS is managed for millions of patients. At the same time, the scientific infrastructure, regulatory expertise, and ELISA development capabilities we have built to bring inFoods to market are now generating direct revenue through our CDMO business.

The $1.75 million in initial development fees provides near-term revenue visibility and demonstrates that the capabilities Biomerica has built over more than 40 years — in assay development, regulatory compliance, and IVD manufacturing — have direct commercial value beyond our own product pipeline.”

— Zack Irani, Chief Executive Officer, Biomerica, Inc.

The identity of the partner organization is not being disclosed at this time pursuant to confidentiality obligations.

ABOUT BIOMERICA, INC.

Biomerica, Inc. (Nasdaq: BMRA) is a global biomedical technology company that develops, manufactures, and markets diagnostic test systems and provides integrated CDMO services for the healthcare market. The Company specializes in immunoassay-based technologies, including ELISA and lateral flow platforms, with more than 40 years of expertise in assay development, manufacturing, and regulatory compliance. Biomerica holds ISO 13485 certification, is registered with the U.S. Food and Drug Administration, and has supported regulatory submissions in multiple jurisdictions including FDA 510(k) clearances and EU IVDR registrations. The Company’s flagship inFoods® IBS product is a precision diagnostic-guided therapy validated in a landmark multicenter clinical trial published in Gastroenterology. For more information, visit www.biomerica.com and www.inFoodsIBS.com.

INVESTOR RELATIONS CONTACT Biomerica, Inc. │ 17571 Von Karman Ave, Irvine, CA 92614 investors@biomerica.com │ (949) 645-2111 │ www.biomerica.com

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the target contract development fee of approximately $1.75 million, expectations regarding SOW execution, milestone completion, and program timelines, and the Company’s expectations regarding its CDMO business as a revenue stream. The $1.75 million aggregate estimate is across multiple SOWs that have not all been executed; no revenue is recognized absent an executed SOW and accepted milestone deliverables. Actual results may differ materially due to SOW non-execution, program cancellation, MSA termination, and other risks described in the Company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Biomerica undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law.

Source: Biomerica, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Biomerica (NASDAQ: BMRA) announce on May 28, 2026 about its CDMO business?

Biomerica announced a CDMO Master Services Agreement to develop proprietary IVD assays with a confidential life sciences company. According to Biomerica, the agreement targets over $1.75 million in initial development fees, supporting its strategy of a capital-efficient, parallel revenue stream.

How much is the Biomerica (BMRA) CDMO Master Services Agreement potentially worth?

The CDMO Master Services Agreement carries an initial contract development target fee of over $1.75 million. According to Biomerica, this amount will be earned across multiple Statements of Work, with revenue recognized on a milestone-completion basis as individual deliverables are accepted.

What is the term of Biomerica’s new CDMO Master Services Agreement and renewal structure?

The CDMO Master Services Agreement has an initial three-year term with automatic one-year renewals. According to Biomerica, this structure can provide ongoing CDMO revenue opportunities, assuming future Statements of Work and continued collaboration with the confidential life sciences partner.

Where will Biomerica (BMRA) perform the IVD assay development work under this CDMO agreement?

All development work will be performed at Biomerica’s FDA-licensed, ISO 13485-certified facility in Irvine, California. According to Biomerica, existing research scientists, equipment, and infrastructure will be used, supporting a capital-light structure with minimal expected incremental costs as the CDMO program scales.

How does the new CDMO Master Services Agreement align with Biomerica’s inFoods IBS strategy?

The CDMO engagement uses the same ELISA-based assay expertise behind Biomerica’s inFoods IBS platform. According to Biomerica, CDMO services are a parallel, capital-efficient revenue stream, while inFoods IBS remains the company’s primary commercial priority and core strategic focus.

How will Biomerica recognize revenue from the $1.75 million CDMO Master Services Agreement?

Biomerica will recognize CDMO revenue on a milestone-completion basis as individual Statements of Work deliverables are accepted. According to Biomerica, this approach ties revenue timing directly to project progress and accepted milestones under the Master Services Agreement.

Why was Biomerica selected for this IVD CDMO Master Services Agreement?

Biomerica was chosen following a competitive evaluation of multiple CDMO organizations. According to Biomerica, the decision reflects its ELISA-based assay development experience, regulatory expertise, and over 40 years of work in assay development, regulatory compliance, and IVD manufacturing capabilities.