Polyrizon Announces GMP Manufacturing of Clinical Trial Material (CTM) with Eurofins CDMO AmatsiAquitaine S.A.S for Planned U.S. Clinical Study

Rhea-AI Summary

Polyrizon (Nasdaq: PLRZ) announced successful GMP manufacturing of a clinical trial material (CTM) batch with Eurofins CDMO AmatsiAquitaine S.A.S on March 10, 2026. The GMP batch follows two development batches showing batch-to-batch consistency and stability and supports a planned U.S. clinical study later in 2026.

This milestone advances Polyrizon's intranasal platform toward clinical testing and regulatory submissions for its lead product candidate.

Positive

• Completed a GMP CTM batch with Eurofins CDMO AmatsiAquitaine
• Prior two development batches demonstrated batch-to-batch consistency and stability
• GMP material supports planned U.S. clinical study and regulatory submissions in 2026

Negative

• Company remains at a pre-clinical stage and has no clinical efficacy data yet
• Planned U.S. clinical study is not yet initiated; timeline subject to regulatory and operational steps

News Market Reaction – PLRZ

-0.15%

1 alert

-0.15% News Effect

-$29K Valuation Impact

$20M Market Cap

0.2x Rel. Volume

On the day this news was published, PLRZ declined 0.15%, reflecting a mild negative market reaction. This price movement removed approximately $29K from the company's valuation, bringing the market cap to $20M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Shelf capacity: $50,000,000 Reverse split ratio: 1-for-6 Pre-split shares: 6,250,053 shares +2 more

5 metrics

Shelf capacity $50,000,000 Form F-3 filed Nov 7, 2025

Reverse split ratio 1-for-6 Reverse share split effective Nov 28, 2025

Pre-split shares 6,250,053 shares Issued and outstanding before reverse split

Post-split shares 1,041,676 shares Issued and outstanding after reverse split

Development batches 2 batches Preceded GMP CTM batch; showed consistency and stability

Market Reality Check

Price: $13.60 Vol: Volume 8,229 is well belo...

low vol

$13.60 Last Close

Volume Volume 8,229 is well below 20-day average of 41,003, signaling limited pre-news positioning. low

Technical Price $12.98 is trading above the 200-day MA of $8.09, after a steep decline from the 52-week high.

Peers on Argus

PLRZ slipped -0.99% while key biotech peers were mixed: ADTX down modestly and S...

1 Down

PLRZ slipped -0.99% while key biotech peers were mixed: ADTX down modestly and SILO up, with only 1 peer in momentum scanners. Moves do not indicate a coordinated sector reaction.

Previous Clinical trial Reports

5 past events · Latest: Jan 05 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 05	Preclinical allergen data	Positive	-0.8%	In‑vitro PL-14 data showed strong Der p 1 allergen‑blocking vs HPMC.
Oct 06	Preclinical efficacy data	Positive	+4.6%	Positive PL-14 preclinical results with low Der p 1 penetration percentages.
May 21	Platform performance data	Positive	+3.9%	Hydrogel platform showed strong mucoadhesion and nasal surface coverage ex vivo.
May 13	Epilepsy preclinical start	Positive	-91.9%	Initiated preclinical intranasal benzodiazepine studies targeting seizure market.
Mar 25	Epilepsy study launch	Positive	-13.0%	Launched T&T platform epilepsy studies with large market sizing figures.

Pattern Detected

Clinical-trial news has produced mixed but often negative next-day moves, with 3 of 5 prior updates selling off despite positive preclinical data.

Recent Company History

Over the past year, Polyrizon has repeatedly highlighted positive preclinical and intranasal platform data. Clinical‑trial‑tagged releases since Mar 2025 have focused on allergen blocking, epilepsy rescue concepts, and nasal protection performance. Market reactions have been volatile, including sharp downside moves despite favorable results. Today’s GMP manufacturing milestone fits the path from preclinical validation toward first U.S. clinical evaluation for its intranasal allergy platform.

Historical Comparison

-19.4% avg move · Past 5 clinical‑trial updates averaged a -19.43% next‑day move, showing volatile reactions. Today’s ...

clinical trial

-19.4%

Average Historical Move clinical trial

Past 5 clinical‑trial updates averaged a -19.43% next‑day move, showing volatile reactions. Today’s GMP CTM milestone continues the shift from preclinical data toward first U.S. clinical testing.

Clinical‑trial‑tagged news shows a progression from preclinical allergen‑blocking and epilepsy concepts toward usability work for NASARIX™ and now GMP CTM production, setting up planned U.S. clinical studies.

Regulatory & Risk Context

Active S-3 Shelf · $50,000,000

Shelf Active

Active S-3 Shelf Registration 2025-11-07

$50,000,000 registered capacity

An effective Form F-3 shelf filed on Nov 7, 2025 allows Polyrizon to register and potentially issue up to $50,000,000 of securities over time, which could be used to fund clinical development and other initiatives but may be dilutive if fully utilized.

Market Pulse Summary

This announcement marks completion of a GMP batch of CTM for Polyrizon’s lead intranasal candidate, ...

Analysis

This announcement marks completion of a GMP batch of CTM for Polyrizon’s lead intranasal candidate, enabling a planned U.S. clinical study. It follows prior development batches that demonstrated manufacturing consistency and stability. In context of earlier preclinical and usability milestones, the news advances the program from laboratory work toward human testing. Investors may watch for trial initiation timing, regulatory feedback, and any capital raises under the $50,000,000 shelf as key next checkpoints.

Key Terms

good manufacturing practice (gmp), gmp, clinical trial material (ctm), ctm, +2 more

6 terms

good manufacturing practice (gmp) regulatory

"announced the successful production of a Good Manufacturing Practice (GMP) batch"

Good Manufacturing Practice (GMP) is a set of government-enforced standards that ensure medicines, medical devices, and related products are produced consistently, safely, and with the quality claimed on the label. Think of it as a strict recipe and hygiene checklist for a factory that prevents contamination, errors, and product variations. Investors care because GMP compliance affects a company’s ability to sell products, avoid costly recalls or regulatory shutdowns, and maintain reliable revenue and reputation.

gmp regulatory

"a leading global GMP CDMO, established to support the supply of clinical trial material"

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

clinical trial material (ctm) technical

"GMP batch of clinical trial material (CTM) for its lead product candidate"

Clinical trial material (CTM) is the actual drug, therapy, device or placebo and its packaging, labeling and instructions that are produced specifically for use in a human clinical study. Investors care because CTM is like a prototype batch: its availability, quality and regulatory compliance drive whether trials can start or continue on schedule, affect development costs and influence the likelihood and timing of potential approval and future revenue.

ctm technical

"The CTM batch was produced in compliance with applicable GMP standards"

Clinical trial material (CTM) is the actual drug, vaccine, device or placebo manufactured and packaged for use in a clinical study. Investors care because availability, quality, and timing of CTM production directly affect a trial’s schedule and regulatory approval prospects—think of it as the ingredients and boxed product a company needs on hand to run its tests without delays. Problems with CTM can slow development, raise costs, or halt trials, which can materially impact a company’s value.

cdmo technical

"Eurofins CDMO AmatsiAquitaine S.A.S, a leading global GMP CDMO"

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.

intranasal medical

"biotechnology company developing intranasal administrated solutions"

Administration or delivery of a drug or vaccine through the nose, typically via a spray or drops that are absorbed by the nasal tissues. For investors, intranasal products can matter because they often offer easier, needle-free use, faster onset of effect, and potential cost or compliance advantages that can widen a product’s market and affect regulatory review, manufacturing complexity, and commercial prospects — similar to how a convenient app can outsell a clunky desktop program.

AI-generated analysis. Not financial advice.

Raanana, Israel, March 10, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a pre-clinical-stage biotechnology company developing intranasal administrated solutions, today announced the successful production of a Good Manufacturing Practice (GMP) batch of clinical trial material (CTM) for its lead product candidate.

This milestone follows the Company’s previously announced manufacturing agreement with Eurofins CDMO AmatsiAquitaine S.A.S, a leading global GMP CDMO, established to support the supply of clinical trial material for Polyrizon’s clinical development program.

The GMP manufacturing milestone represents a key step in Polyrizon’s clinical development program and supports the company’s preparations for a planned clinical study in the United States later this year.

The GMP batch was manufactured following the successful production of two prior development batches, which demonstrated batch-to-batch consistency and product stability over time, supporting the robustness and reproducibility of the manufacturing process.

The CTM batch was produced in compliance with applicable GMP standards in collaboration with Eurofins CDMO AmatsiAquitaine S.A.S, and will be used to support upcoming clinical activities and regulatory submissions related to the study.

“This manufacturing milestone represents an important step in advancing our clinical development strategy,” said Tomer Izraeli, CEO of Polyrizon. “Following the successful production of development batches that confirmed manufacturing consistency and stability, the GMP production of clinical material enables us to move forward with our planned U.S. clinical study and reflects our continued commitment to developing innovative intranasal solutions designed to protect against airborne allergens and viruses.”

This milestone reflects Polyrizon’s continued progress toward advancing its intranasal technology platform and bringing novel preventive solutions for respiratory conditions closer to patients.

About Polyrizon

Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses continuing to advance its naloxone program as part of its broader intranasal platform strategy. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report filed with the SEC on March 11, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites.

Contacts:
Michal Efraty
Investor Relations
IR@polyrizon-biotech.com

FAQ

What did Polyrizon (PLRZ) announce on March 10, 2026 about GMP manufacturing?

Polyrizon announced the successful production of a GMP clinical trial material (CTM) batch with Eurofins CDMO AmatsiAquitaine. According to the company, this follows two development batches showing consistency and stability and supports a planned U.S. clinical study later in 2026.

How does the GMP CTM batch affect Polyrizon's planned U.S. clinical study (PLRZ)?

The GMP batch enables preparation for clinical activities and regulatory filings needed to start clinical testing. According to the company, the material was produced to support the planned U.S. study and related submissions later in 2026.

What evidence did Polyrizon provide for manufacturing robustness for PLRZ's product?

Polyrizon said two prior development batches demonstrated batch-to-batch consistency and product stability. According to the company, those results supported the transition to GMP production with Eurofins CDMO AmatsiAquitaine.

Who manufactured Polyrizon's GMP clinical trial material (PLRZ)?

The GMP CTM was produced in collaboration with Eurofins CDMO AmatsiAquitaine S.A.S. According to the company, Eurofins performed the batch in compliance with applicable GMP standards to support clinical use and submissions.

Does Polyrizon's announcement mean the PLRZ product is approved for market use?

No; the announcement relates to GMP manufacturing of trial material, not regulatory approval. According to the company, the material supports upcoming clinical activities and regulatory submissions but approvals remain pending.