Polyrizon Announces New Pre-Clinical Results: PL-14 Demonstrates Significant Allergen-Blocking Performance Compared to a Standard Comparator

Rhea-AI Summary

Polyrizon (Nasdaq: PLRZ) reported in-vitro pre-clinical results for its PL-14 Allergy Blocker showing significantly reduced transfer of the house dust mite allergen Der p 1 versus the standard comparator HPMC in a validated Transwell permeability model.

Key data: PL-14 reduced Der p 1 transfer at all time points (1, 2, 4, 6, 24 hours) with p ≤ 0.0042. At 1 hour mean Der p 1 was ~20.6 ng for PL-14 versus ~1,354.4 ng for HPMC; HPMC rose to ~5,201.2 ng at 24 hours while PL-14 peaked at ~141.2 ng at 4 hours. The company said it will advance PL-14 toward clinical studies to define regulatory pathway and real-world benefit.

Positive

• Statistically significant allergen reduction at all time points (p ≤ 0.0042)
• Mean Der p 1 at 1 hour: PL-14 ~20.6 ng vs HPMC ~1,354.4 ng
• HPMC reached ~5,201.2 ng at 24 hours; PL-14 peak ~141.2 ng at 4 hours

Negative

• Results are in-vitro pre-clinical data only; clinical efficacy not established
• Regulatory pathway and real-world benefit remain to be demonstrated in future studies

Key Figures

Time points 1, 2, 4, 6, 24 hours Der p 1 transfer assessment versus HPMC

p-values ≤ 0.0042 PL-14 vs HPMC Der p 1 transfer at all time points

PL-14 allergen level ~20.6 ng Der p 1 penetration at 1 hour with PL-14

HPMC allergen level ~1354.4 ng Der p 1 penetration at 1 hour with HPMC

HPMC at 24 hours ~5201.2 ng Der p 1 mean concentration after 24 hours with HPMC

PL-14 peak level ~141.2 ng Maximum mean Der p 1 level (4 hours) with PL-14

Market Reality Check

$12.79 Last Close

Volume Volume 1,055,497 is below the 20-day average of 1,694,648, suggesting limited participation before this update. low

Technical Shares traded below the 200-day MA of 135.69, reflecting a depressed longer-term trend despite recent strength.

Peers on Argus

Healthcare/biotech peers showed mixed moves (e.g., ADTX +4.55%, TTNP -3.96%, SILO -4.11%), pointing to stock-specific drivers for PLRZ rather than a clear sector swing.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Jan 02	Flu-season PL-16 update	Positive	+50.2%	Positioned PL-16 viral blocker as added protection amid severe flu season.
Dec 29	Capital allocation update	Positive	-1.4%	Board authorized exploring revenue-generating real assets with strong cash and no debt.
Dec 19	PL-16 Pre-RFD filing	Positive	-6.7%	Submitted Pre-RFD to FDA for PL-16 intranasal viral blocker with >90% protection.
Dec 11	Naloxone hydrogel data	Positive	+11.5%	Reported stable, strongly mucoadhesive naloxone hydrogel with rapid permeation kinetics.
Dec 08	PL-14 FDA meeting	Positive	-15.7%	Completed FDA pre-submission meeting for PL-14, outlining trials expected to start 2026.

Pattern Detected

News is typically positive R&D or strategic progress, but price reactions have been inconsistent, with several sell-offs following seemingly constructive updates.

Recent Company History

Over the last month, Polyrizon has highlighted its intranasal pipeline and balance-sheet flexibility. Updates included PL-16 viral blocker data and a Pre-Request for Designation submission (Dec 19, 2025), exploration of revenue-generating real assets (Dec 29, 2025), and PL-14 regulatory preparation (Dec 8, 2025). Price moves have alternated between sharp gains (e.g., flu-season PL-16 positioning at +50.18%) and notable declines, indicating unstable sentiment around similar R&D milestones.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-11-07

$50,000,000 registered capacity

An effective Form F-3 shelf for up to $50,000,000 of ordinary shares, warrants, and units gives Polyrizon flexibility to raise capital via offerings such as at-the-market or underwritten deals, which could introduce future equity issuance if utilized.

Market Pulse Summary

This announcement adds quantitative support for PL-14’s allergen-blocking potential, showing significantly reduced Der p 1 transfer versus an HPMC comparator with p-values ≤ 0.0042. It builds on prior PL-14 and platform preclinical results while the company prepares for clinical studies. At the same time, Polyrizon maintains flexibility through a $50,000,000 F-3 shelf, so future financing choices, clinical design, and regulatory feedback remain key metrics to monitor.

Key Terms

in-vitro medical

"positive results from a new in-vitro pre-clinical study evaluating the allergen-blocking"

In-vitro means a laboratory test or experiment done outside a living organism, typically in a test tube, petri dish, or similar container. For investors, in-vitro results are early-stage evidence that a compound or process can work under controlled lab conditions; they can spark interest and influence valuation but carry higher uncertainty because success in a dish does not guarantee safety or effectiveness in people.

hydroxypropyl methylcellulose medical

"compared to hydroxypropyl methylcellulose (HPMC), an accepted and standard comparator"

A plant-derived, food- and pharma-grade polymer used as a thickener, binder, film former and tablet/capsule coating in medicines and consumer products; think of it as the glue and protective skin that holds ingredients together and controls how quickly they dissolve. Investors care because its quality, availability and regulatory acceptance affect manufacturing consistency, product shelf life, dosing reliability and supply-chain cost, all of which influence product approvals and commercial performance.

transwell permeability system medical

"using a validated in-vitro Transwell permeability system designed to mimic allergen"

A transwell permeability system is a laboratory setup that mimics a thin layer of cells grown on a porous membrane to test how easily drugs or molecules cross from one side to the other. Think of it like a tiny, controlled filter or fence that lets researchers watch whether a compound can pass through a cellular barrier. Results matter to investors because they help predict a candidate’s likely absorption, distribution or ability to reach target tissues, which affects development risk, cost and commercial potential.

nasal mucosa medical

"designed to mimic allergen transfer into the nasal mucosa, assessed PL-14’s ability"

The nasal mucosa is the soft, moist lining inside the nose that produces mucus and acts like a protective carpet or sponge, trapping particles and helping control moisture and air flow. For investors, its condition determines how well nasal drugs, vaccines or diagnostic swabs are absorbed and tolerated, so findings about irritation, effectiveness, or delivery can materially affect regulatory approval, market potential and commercial success of related products.

der p 1 medical

"inhibit transfer of Der p 1, a major clinically relevant house dust mite allergen"

Der p 1 is a specific protein produced by the common house dust mite that acts as a key trigger for allergic reactions in many people. Investors should care because this protein is the target ingredient in diagnostic tests and allergy therapies—think of it as the identifiable “fingerprint” used to detect and treat dust-mite allergy—so regulatory approvals, clinical results, or supply changes involving Der p 1 can directly affect the commercial value of related medical products.

allergic rhinitis medical

"house dust mite allergen commonly associated with allergic rhinitis and asthma."

An immune-driven inflammation of the nose and sinuses triggered by allergens such as pollen, dust or pet dander, causing sneezing, congestion, runny nose and itchy eyes. It matters to investors because its prevalence and seasonality affect demand for prescription drugs, over-the-counter treatments, diagnostics and related healthcare services, creating predictable sales cycles and potential market opportunities; think of it as an overly sensitive smoke alarm that drives repeat purchases.

p-values medical

"time point (1, 2, 4, 6, and 24 hours), with p-values ≤ 0.0042."

A p-value is a number that estimates how likely it is that an observed result happened by random chance rather than because of a real effect. Think of it like testing whether a coin is fair: a very small p-value means the outcome would be unlikely if nothing unusual were happening. For investors, p-values help judge whether reported study or test results are likely meaningful or just noise, but they are not proof and should be weighed with study size, design and real-world relevance.

AI-generated analysis. Not financial advice.

Raanana, Israel, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a pre-clinical-stage biotechnology company developing intranasal protective solutions today announced positive results from a new in-vitro pre-clinical study evaluating the allergen-blocking performance of its PL-14 Allergy Blocker formulation compared to hydroxypropyl methylcellulose (HPMC), an accepted and standard comparator used in nasal barrier products.

The study, conducted using a validated in-vitro Transwell permeability system designed to mimic allergen transfer into the nasal mucosa, assessed PL-14’s ability to inhibit transfer of Der p 1, a major clinically relevant house dust mite allergen commonly associated with allergic rhinitis and asthma.

Key findings demonstrated that PL-14 significantly reduced allergen transfer at all time points compared with HPMC, including early time points that are considered critical for preventing allergen-triggered immune activation. Statistical analysis showed that PL-14 significantly reduced Der p 1 transfer compared with HPMC at every tested time point (1, 2, 4, 6, and 24 hours), with p-values ≤ 0.0042.

Highlights from the Study

• PL-14 showed markedly lower allergen transfer versus HPMC throughout the experiment, supporting a consistent barrier effect.
   
• At 1 hour, PL-14 demonstrated very low allergen penetration, with measured mean concentrations of ~20.6 ng compared with ~1354.4 ng for HPMC.
   
• HPMC exhibited substantial and time-dependent allergen permeation, rising to mean concentrations of ~5201.2 ng at 24 hours, consistent with limited barrier function.
   
• PL-14 maintained low mean allergen levels across all time points, reaching a maximum mean value of ~141.2 ng at 4 hours, supporting a sustained protective effect.

“These results reinforce our belief that PL-14 can form an effective intranasal hydrogel barrier capable of reducing allergen exposure to nasal tissue,” said Tomer Izraeli, CEO of Polyrizon. “Importantly, this study benchmarked PL-14 against HPMC, an accepted comparator, and demonstrated statistically significant reduction in allergen transfer at all evaluated time points.

From an R&D standpoint, we believe that this is an important confirmation of the performance of the PL-14 formulation using a rigorous quantitative permeation model. The data support continued advancement of PL-14 as a potential preventive approach for allergic rhinitis by reducing allergen penetration through a synthetic surface.”

Polyrizon continues to advance its preclinical development program and plans to support future clinical studies aimed at establishing PL-14’s regulatory pathway and real-world clinical benefit for allergy prevention.

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 continued advancement of PL-14 as a potential preventive approach for allergic rhinitis by reducing allergen penetration through a synthetic surface and how the Company continues to advance its preclinical development program and plans to support future clinical studies aimed at establishing PL-14’s regulatory pathway and real-world clinical benefit for allergy prevention. 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 announce about PL-14 on January 5, 2026 (PLRZ)?

Polyrizon announced in-vitro pre-clinical results showing PL-14 significantly reduced Der p 1 transfer versus HPMC at 1, 2, 4, 6, and 24 hours with p ≤ 0.0042.

How much lower was Der p 1 transfer with PL-14 versus HPMC at 1 hour in the PLRZ study?

At 1 hour mean Der p 1 was ~20.6 ng with PL-14 versus ~1,354.4 ng with HPMC.

Does the PLRZ release show PL-14 is effective in humans?

No; the announcement describes in-vitro pre-clinical results only and states that clinical studies are planned to establish real-world benefit.

What model did Polyrizon use to test PL-14 (PLRZ) allergen blocking performance?

The company used a validated in-vitro Transwell permeability system designed to mimic allergen transfer into nasal mucosa.

What were the 24-hour allergen transfer results for PL-14 and HPMC in the PLRZ study?

HPMC rose to ~5,201.2 ng at 24 hours while PL-14 maintained low levels (PL-14 maximum mean reported was ~141.2 ng at 4 hours).