Jyong Biotech Reports Transformative Period of Clinical Validation and Commercialization Attempt: Phase II Data Focuses on Dual Therapeutic Potential of MCS-8 in Oncology and Metabolic Health, Alongside Strategic Market Entry into Asia

Rhea-AI Summary

Jyong Biotech (Nasdaq: MENS) reported completion of a Phase II trial for lead candidate MCS-8, showing a 27.3% reduction in prostate cancer incidence and a 17.1% reduction in high-grade disease versus placebo.

Phase II also showed favorable lipid changes (HDL, LDL, triglycerides) with statistical significance, a clean two-year safety signal including stable LDH, and non-binding commercial agreements in South Korea and Vietnam as the company evaluates Asian market entry.

Positive

• 27.3% reduction in overall prostate cancer incidence versus placebo
• 17.1% reduction in high-grade prostate cancer (Gleason ≥7)
• Lipid improvements with significant HDL increase (P=0.003) and LDL/triglyceride decreases
• No drug-related serious adverse events and stable LDH over two years
• Regional commercial steps with LOI in South Korea and MOU in Vietnam

Negative

• Phase II only; MCS-8 requires global Phase III to seek approval
• MCS-2 and MCS-8 investigational and not approved for commercial use
• Commercial agreements non-binding (LOI and MOU), creating execution uncertainty

News Market Reaction

+0.68%

13 alerts

+0.68% News Effect

+17.2% Peak in 2 hr 17 min

+$945K Valuation Impact

$140M Market Cap

0.9x Rel. Volume

On the day this news was published, MENS gained 0.68%, reflecting a mild positive market reaction. Argus tracked a peak move of +17.2% during that session. Our momentum scanner triggered 13 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $945K to the company's valuation, bringing the market cap to $140M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Phase II enrollment: over 700 high-risk subjects Trial centers: 20 medical centers Prostate cancer reduction: 27.3% reduction +5 more

8 metrics

Phase II enrollment over 700 high-risk subjects Phase II randomized, placebo-controlled trial for MCS-8 in Taiwan

Trial centers 20 medical centers Sites participating in MCS-8 Phase II trial in Taiwan

Prostate cancer reduction 27.3% reduction Overall incidence of prostate cancer vs. placebo in MCS-8 arm

High-grade cancer reduction 17.1% reduction High-grade prostate cancer (Gleason score ≥ 7) vs. placebo

Positive biopsy cores 35.2% reduction Reduction in percentage of positive biopsy cores with MCS-8

Cancer-positive area 24.4% reduction Cancer-positive area within biopsy cores in MCS-8 group

Total cholesterol p-value P = 0.036 Statistically significant reduction in total cholesterol after two years

HDL p-value P = 0.003 Significant increase in HDL levels in MCS-8 group

Market Reality Check

Price: $1.55 Vol: Volume 335,821 is below t...

normal vol

$1.55 Last Close

Volume Volume 335,821 is below the 20-day average of 382,039 (relative volume 0.88x). normal

Technical Shares at $1.46 are trading below the 200-day moving average of $28.62 and sit near the 52-week low of $1.43, far from the $67 52-week high.

Peers on Argus

Most biotech peers show modest single-day declines (e.g., CRSP -1.99%, MRUS -7.0...

Most biotech peers show modest single-day declines (e.g., CRSP -1.99%, MRUS -7.08%), with one flat-to-slightly-up name (RNA +0.05%). Moves are mixed and do not clearly mirror MENS’s -9.88% drop, suggesting a stock-specific reaction.

Previous Clinical trial Reports

4 past events · Latest: Jan 30 (Positive)

Same Type Pattern 4 events

Date	Event	Sentiment	Move	Catalyst
Jan 30	Biomarker analysis	Positive	-7.8%	Reported lipid and LDH biomarker benefits after two years of MCS-8.
Nov 20	Phase II results	Positive	+12.4%	Disclosed positive primary endpoint data from Phase II MCS-8 prostate trial.
Sep 16	Enrollment complete	Positive	+5.0%	Completed enrollment of over 700 subjects in Phase II MCS-8 study.
Aug 22	Conference data	Positive	+6.6%	Presented Phase II MCS-8 and Phase III BOTRESO data at urology congress.

Pattern Detected

Clinical-trial news for MENS has usually drawn positive reactions, with 3 of the last 4 such updates trading higher, but the January 2026 biomarker release saw a notable selloff despite favorable data.

Recent Company History

Over the past six months, Jyong Biotech has built a consistent clinical narrative around MCS-8. In Aug–Sep 2025 it completed enrollment of over 700 subjects and presented Phase II data at a regional congress, both followed by positive price reactions. The Nov 20, 2025 primary-endpoint analysis showed a 27.3% prostate cancer incidence reduction and was also rewarded. A Jan 30, 2026 update on cholesterol and LDH markers was clinically encouraging but traded lower. Today’s update largely consolidates these Phase II findings while adding commercialization commentary.

Historical Comparison

+4.1% avg move · In the past year, MENS released 4 clinical-trial updates, averaging a 4.06% move. Today’s Phase II r...

clinical trial

+4.1%

Average Historical Move clinical trial

In the past year, MENS released 4 clinical-trial updates, averaging a 4.06% move. Today’s Phase II recap plus dual-indication framing extends this same clinical theme.

Clinical updates progressed from initial Phase II data presentations and enrollment completion to detailed primary-endpoint analysis and biomarker findings, culminating in a narrative of dual oncologic and metabolic potential for MCS-8.

Market Pulse Summary

This announcement consolidates Phase II evidence that MCS-8 reduced prostate cancer incidence by 27....

Analysis

This announcement consolidates Phase II evidence that MCS-8 reduced prostate cancer incidence by 27.3% and high-grade disease by 17.1%, while also improving lipid markers such as total cholesterol and HDL. It also reiterates regional partnership steps for MCS-2 in Korea and Vietnam. Investors may monitor future regulatory interactions, any Phase III trial initiation, and how the company’s capital position and leadership changes, like the new CFO, support advancing these investigational assets.

Key Terms

phase ii, randomized, placebo-controlled, gleason score, triglycerides, +4 more

8 terms

phase ii medical

"successful completion of the Phase II clinical trial for its lead candidate, MCS-8"

Phase II is the mid-stage clinical trial where a potential drug or medical treatment is tested in a larger group of patients to see if it works and to help determine the best dose and common side effects. For investors, Phase II results matter because they give the first meaningful evidence about effectiveness and safety—like a road test that shows whether a product has real promise before a much bigger, costly final trial and potential regulatory approval.

randomized, placebo-controlled medical

"Phase II randomized, placebo-controlled trial for MCS-8, which enrolled over 700"

A randomized, placebo-controlled trial is a medical study where people are assigned by chance (like flipping a coin) to receive either the experimental treatment or an inactive substitute (a placebo), and neither participants nor often the researchers know who got which. For investors, this design is the gold standard for showing whether a therapy truly works beyond chance or expectation, which reduces uncertainty about regulatory approval, market adoption, and the commercial value of a drug or device.

gleason score medical

"high-grade prostate cancer (Total Gleason Score ≥ 7). This finding is clinically"

A Gleason score is a number assigned by a pathologist after examining prostate tissue under a microscope to describe how much the cancer cells differ from normal cells and how likely the tumor is to grow and spread. Think of it as a heat‑map rating for aggressiveness: higher scores mean more aggressive disease and a greater need for intensive treatment. For investors, Gleason scores influence expected patient outcomes, treatment choices, and the market size and urgency for related diagnostics and therapies.

triglycerides medical

"group showed decreased triglycerides (P = 0.05) and LDL levels (P = 0.018)"

Triglycerides are the main form of fat carried in the bloodstream, made from excess calories and used by the body for energy or stored in fat tissue; think of them as the oil reserves that fuel the body. They matter to investors because high or low levels influence demand for drugs, diagnostics, and healthcare services, affect regulatory reviews and insurance costs, and signal population health trends that can change market size and company risk.

ldl medical

"group showed decreased triglycerides (P = 0.05) and LDL levels (P = 0.018)"

Low-density lipoprotein (LDL) is the main carrier of cholesterol in the blood, often called “bad” cholesterol because too much can stick to artery walls and increase heart disease risk. Investors monitor LDL-related tests, drugs and therapies because shifts in how LDL is managed affect demand for medical products, insurance and healthcare spending—think of LDL like traffic; more congestion drives up costs and risk across the health sector.

hdl medical

"LDL levels (P = 0.018), alongside a significant increase in HDL (P = 0.003)"

HDL stands for high-density lipoprotein, a type of cholesterol-carrying particle in the blood that helps remove excess cholesterol from arteries and transport it to the liver for disposal. Investors care because HDL levels are a widely used indicator of cardiovascular health; changes in HDL-related science, therapies, or population health trends can affect drug development, insurance costs and the valuation of healthcare and medical-device companies — think of HDL as the body’s cleanup truck for cholesterol.

lactate dehydrogenase (ldh) medical

"analysis of Lactate Dehydrogenase (LDH), a ubiquitous enzyme used as a clinical marker"

Lactate dehydrogenase (LDH) is an enzyme found throughout the body that helps cells convert sugar into energy and is released into the blood when tissues are stressed or damaged. Investors watch LDH levels because they act like a simple gauge—similar to a car’s warning light—indicating disease activity, organ injury, or treatment effects; unexpected changes can affect a drug’s safety profile, clinical trial readouts, or the perceived health of a company’s assets.

investigational new drug regulatory

"MCS-2 and MCS-8 remain investigational new drug candidates and have not been approved"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

AI-generated analysis. Not financial advice.

- Comprehensive review of recent milestones highlights statistically significant efficacy in prostate cancer prevention, discovery of novel lipid-modulating properties, and the execution of high-value commercial partnerships in South Korea and Vietnam.

New Taipei City, Taiwan, Feb. 12, 2026 (GLOBE NEWSWIRE) -- Jyong Biotech Ltd. (Nasdaq: MENS) (the “Company” or “Jyong Biotech”), a science-driven biotechnology company dedicated to the development and commercialization of innovative plant-derived therapeutics, today issued a strategic corporate update. This review encapsulates a pivotal period characterized by the successful completion of the Phase II clinical trial for its lead candidate, MCS-8, and the concurrent attempt of its commercial footprint in key Asian markets. The Company believes the convergence of positive oncological endpoints with unexpected metabolic benefits potentially de-risks its pipeline and positions Jyong Biotech at the forefront of preventative medicine.

Unlocking the "Dual-Action" Potential of MCS-8: Oncology Meets Metabolic Health

The Company recently achieved an important milestone with the completion of its Phase II randomized, placebo-controlled trial for MCS-8, which enrolled over 700 high-risk subjects across 20 medical centers in Taiwan. As previously disclosed, the study’s primary efficacy analysis yielded a statistically significant 27.3% reduction in the overall incidence of prostate cancer in the MCS-8 arm compared to placebo. The data also demonstrated a 17.1% reduction in high-grade prostate cancer (Total Gleason Score ≥ 7). This finding is clinically profound, as high-grade malignancies represent the primary driver of prostate cancer mortality, and historical chemoprevention agents have often struggled to demonstrate safety or efficacy in this specific sub-population.

Further pathological stratification revealed a 35.2% reduction in the percentage of positive biopsy cores and a 24.4% reduction in the cancer-positive area within those cores. These metrics suggest that MCS-8 exerts a tangible biological effect on tumor burden and disease progression, potentially offering a superior alternative to the current standard of "active surveillance," which carries the psychological burden of anxiety for patients waiting for disease progression.

Beyond its oncological efficacy, the Phase II data unveiled a significant secondary potential therapeutic profile regarding metabolic regulation. In results announced in January 2026, patients treated with MCS-8 for two years exhibited a statistically significant reduction in total cholesterol (P = 0.036). The study further highlighted a favorable lipid-modulating trend where the MCS-8 group showed decreased triglycerides (P = 0.05) and LDL levels (P = 0.018), alongside a significant increase in HDL (P = 0.003). In contrast, the placebo group experienced a statistically significant rise in fasting glucose (P = 0.022).

From a scientific perspective, the link between metabolic syndrome—characterized by dyslipidemia and hyperglycemia—and prostate carcinogenesis is well-documented in oncological literature. The ability of MCS-8 to simultaneously lower cancer incidence while improving the lipid profile suggests a potential synergistic mechanism of action that targets the metabolic dysregulation often fueling tumor growth. This "dual-action" capability supports the Company’s strategic evaluation of expanding MCS-8’s indications to include atherosclerosis and cardiovascular disease management.

Safety Profile and Cytoprotective Indicators

Long-term safety remains the primary barrier to entry for preventative therapies. The Phase II study provided significant indications of MCS-8’s safety profile over a two-year administration period. There were no serious adverse events related to the drug, and no negative impacts were observed on blood pressure, liver or kidney function.

Notably, the analysis of Lactate Dehydrogenase (LDH), a ubiquitous enzyme used as a clinical marker for tissue damage and cellular necrosis, offered further validation of safety. The placebo group exhibited a statistically significant increase in serum LDH levels (P = 0.024) over the trial period, potentially indicating baseline cellular stress or turnover inherent to the aging high-risk population. Conversely, the MCS-8 group showed no such elevation. The stability of LDH levels in the treatment arm serves as a biomarker for cytoprotection, reinforcing the hypothesis that MCS-8 does not induce cellular toxicity, a critical differentiator for a drug intended for long-term prophylactic use.

Embarking Commercialization via Non-Binding Strategic Asian Partnerships

Parallel to its clinical successes, Jyong Biotech has executed on its strategy to monetize its pipeline through regional co-commercialization. In late 2025, the Company formalized a non-binding Letter of Intent (LOI) with a premier South Korean pharmaceutical company to evaluate the in-licensing of MCS-2. As a recognized supplier to general hospitals and clinics, this partner offers the requisite infrastructure to navigate South Korea’s sophisticated regulatory landscape and reimbursement systems.

Subsequently, the Company expanded this initiative into Southeast Asia through a Memorandum of Understanding (MOU) with a specialized pharmaceutical distributor based in Ho Chi Minh City, Vietnam. This agreement initiates due diligence to define the regulatory and commercial pathway for MCS-2 in Vietnam, a market characterized by a rapidly aging population and increasing demand for urological therapeutics.

Management Commentary

“We believe that the past year has transformed Jyong Biotech from a development-stage entity into a company with clinically validated, multi-indication assets,” stated Fu-Feng Kuo, Chairwoman and CEO of Jyong Biotech. “The Phase II data for MCS-8 is particularly exciting because it addresses two of the most prevalent health concerns in the aging male population: prostate cancer risk and metabolic health. By demonstrating that we can potentially reduce cancer incidence while simultaneously improving lipid profiles, we have established a strong scientific foundation for our global Phase III trials in the future. Furthermore, our non-binding strategic alliances in Korea and Vietnam demonstrate our commitment to ensuring these innovative therapies reach patients efficiently. We are moving forward with a clear vision to redefine the standard of care in preventative urology.”

As of present day, MCS-2 and MCS-8 remain investigational new drug candidates and have not been approved for commercial use in any jurisdiction. Jyong Biotech will comply with applicable regulatory disclosure obligations and provide timely, accurate, and complete updates on material developments.

About Jyong Biotech Ltd.

Headquartered in Taiwan, Jyong Biotech Ltd. is a science-driven biotechnology company committed to developing and commercializing innovative and differentiated new drugs (plant-derived), mainly specializing in the treatment of urinary system diseases, with an initial focus on the markets of the U.S., the EU and Asia. Since its inception in 2002, the Company has built integrated capabilities that encompass all key functionalities of drug development, including early-stage drug discovery and development, pharmacology, toxicology, clinical trials, regulatory affairs, manufacturing, and commercialization. Leveraging strong research and development capabilities and a proprietary platform, the Company has been developing a series of botanical drug candidates, including its primary botanical drug candidate, BOTRESO^®, another clinical-stage botanical drug candidate, and other preclinical-stage botanical drug candidates. The Company endeavors to develop and supply first-class innovative drugs to meet customers’ health needs and seeks to be a valuable business organization that is held in high esteem by the public.

For more information, please visit: https://www.jyongbio.com/, https://jyongir.com/.

Forward-Looking Statement

This press release contains forward-looking statements. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as “may, “will, “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company's expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the uncertainties related to market conditions and other factors discussed in the “Risk Factors” section of the registration statement, prospectuses, annual and interim reports, and other filings with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.

For more information, please contact:
Jyong Biotech Ltd.
ir@jyongbio.com

Investor Relations
WFS Investor Relations Inc.
Email: services@wealthfsllc.com
Phone: +1 628 283 9214

FAQ

What did Jyong Biotech announce about MCS-8 Phase II results on February 12, 2026 (MENS)?

The company reported a 27.3% reduction in prostate cancer incidence in Phase II versus placebo. According to the company, the trial enrolled over 700 subjects across 20 centers and showed additional reductions in high-grade disease and tumor burden metrics.

How did MCS-8 affect cholesterol and lipids in the Phase II trial reported by Jyong Biotech (MENS)?

MCS-8 showed statistically significant lipid changes, including increased HDL and reduced LDL and triglycerides. According to the company, treated patients had significant HDL rise (P=0.003) and LDL/triglyceride declines over two years versus placebo.

What safety findings did Jyong Biotech report for MCS-8 in the February 2026 update (MENS)?

No serious adverse events related to MCS-8 were reported and LDH remained stable in the treatment arm. According to the company, two-year data showed no negative effects on blood pressure, liver, or kidney function.

What commercial steps did Jyong Biotech take for MCS-2 and MCS-8 in Asia (MENS)?

Jyong Biotech executed a non-binding LOI in South Korea and an MOU in Vietnam to evaluate in-licensing and distribution. According to the company, both agreements begin due diligence to define regulatory and commercial pathways regionally.

Are MCS-8 and MCS-2 approved for sale following Jyong Biotech's February 12, 2026 announcement (MENS)?

No, both candidates remain investigational and are not approved for commercial use in any jurisdiction. According to the company, further regulatory steps and pivotal trials will be required before approval can be sought.

What are the next development steps Jyong Biotech outlined for MCS-8 after Phase II (MENS)?

The company plans to evaluate global Phase III trials to confirm efficacy and safety in larger populations. According to the company, Phase II data supports expansion of indications and informs design for potential pivotal studies.