Hoth Therapeutics Announces Groundbreaking Positive Results: Hoth's HT-VA GDNF Surpasses Semaglutide in Weight Loss, Glucose Control, and Liver Health in Obesity Model

Rhea-AI Summary

Hoth Therapeutics (NASDAQ: HOTH) reported preclinical VA-backed results showing its HT-VA GDNF outperformed semaglutide in a 12-week CF-1 mouse obesity model. Key findings: female weight attenuation 10–15%, fasting glucose normalized, and liver weight reduced 20–30%. Hoth targets IND-enabling studies toward clinical trials in 2027.

Further analyses (liver pathology, lipids, gene/protein expression) are planned to clarify mechanisms.

Positive

• Female weight attenuation of 10–15%
• Fasting glucose fully normalized in treated mice
• Liver weight reduction of 20–30%
• Program advancing toward IND-enabling studies targeting 2027 trials

Negative

• Results are from a preclinical 12-week mouse model, not human data
• Efficacy primarily highlighted in female mice, with less clarity on males
• Further analyses required (pathology, lipids, gene/protein data) before clinical translation

Key Figures

Weight gain attenuation: 10–15% Liver weight reduction: 20–30% Study duration: 12 weeks +5 more

8 metrics

Weight gain attenuation 10–15% Female mice on high-fat Western diet treated with GDNF

Liver weight reduction 20–30% GDNF effect on liver weight in female obesity model

Study duration 12 weeks Preclinical CF-1 mouse obesity study with VA support

GDNF dose range 2–12 µg/mouse Subcutaneous escalating doses in obesity model

Semaglutide dose 12 ng/g/mouse Comparator dose in head-to-head preclinical study

Obesity market size $200 billion Estimated market referenced for obesity treatments

Global obesity prevalence Over 1 billion people Estimated number of people affected by obesity globally

MASLD prevalence Up to 30% of adults Estimated adult population affected by MASLD

Market Reality Check

Price: $0.8583 Vol: Volume 260,234 is below t...

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Volume Volume 260,234 is below the 20-day average of 704,152 (relative volume 0.37). low

Technical Shares at 0.8583 are trading below the 200-day MA 1.23 and 59.42% under the 52-week high, despite being 30.96% above the 52-week low.

Peers on Argus

HOTH gained 6.2% while close peers showed mixed moves (e.g., LSTA up 0.22%, PASG...

HOTH gained 6.2% while close peers showed mixed moves (e.g., LSTA up 0.22%, PASG down 6.41%), and no peers appeared in the momentum scanner, indicating a stock-specific reaction to the preclinical obesity data.

Historical Context

5 past events · Latest: Feb 05 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 05	Crypto exposure clarification	Neutral	-4.0%	Company addressed rumors, stating it holds no cryptocurrency assets.
Jan 22	HT-001 interim results	Positive	+0.0%	Positive HT-001 PK cohort data with strong response and tolerability.
Jan 21	HT-KIT China patent	Positive	-1.9%	China patent granted for HT-KIT oncology program, strengthening IP estate.
Jan 15	HT-001 FIH trial setup	Positive	+3.4%	IRB approvals for Phase 2a HT-001 trial and disclosure of cash position.
Jan 15	EU regulatory progress	Positive	+3.4%	Positive EU CTIS Part I conclusion enabling multi-country HT-001 trial sites.

Pattern Detected

Recent fundamentally positive announcements have not consistently produced positive price moves, with several clinically and strategically favorable updates met by flat or negative reactions.

Recent Company History

Over the past few weeks, Hoth has reported several pipeline and corporate milestones. On Jan 15, 2026, the company advanced HT-001 with EU regulatory clearance and IRB approvals and saw a 3.35% price gain. A key HT-KIT patent in China on Jan 21, 2026 and strong HT-001 clinical response data on Jan 22, 2026 were followed by flat to slightly negative moves. A Feb 5, 2026 clarification about lacking crypto exposure led to a 4.01% decline. Against this backdrop, today’s positive GDNF obesity data adds another clinically oriented catalyst to an already active pipeline narrative.

Regulatory & Risk Context

Active S-3 Shelf · $50 million

Shelf Active

Active S-3 Shelf Registration 2025-11-14

$50 million registered capacity

An effective Form S-3 shelf filed on Nov 14, 2025 permits Hoth to offer up to $50 million of various securities and resell 1,279,587 shares via prospectus supplements, providing flexibility to raise capital as programs like GDNF, HT-001, HT-KIT, and HT-ALZ advance.

Market Pulse Summary

This announcement highlighted GDNF’s superior performance to semaglutide in a 12-week obesity model,...

Analysis

This announcement highlighted GDNF’s superior performance to semaglutide in a 12-week obesity model, with 10–15% attenuation of weight gain and 20–30% liver weight reduction in female mice. It adds a metabolic and liver-health program to Hoth’s existing HT-001, HT-KIT, and HT-ALZ efforts. Investors monitoring this story may focus on progress toward IND-enabling work, the targeted 2027 clinical start, and how the company uses its $50 million shelf capacity to fund this broader pipeline while managing dilution and development risk.

Key Terms

gdnf, masld, ind-enabling studies, orphan drug designation, +1 more

5 terms

gdnf medical

"GDNF demonstrated superior efficacy over semaglutide in key metrics"

GDNF is a naturally occurring protein that helps support the health and survival of certain nerve cells in the brain and nervous system. Investors care because drugs or therapies that deliver or mimic GDNF could slow or reverse neurodegenerative conditions; like a specialized fertilizer for damaged plants, successful GDNF-based treatments can create large markets, regulatory milestones, patent value and sharp swings in a biotech company's stock depending on clinical trial outcomes and approvals.

masld medical

"obesity affecting over 1 billion people globally and MASLD impacting up to 30% of adults"

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a chronic condition where excess fat builds up in the liver due to underlying metabolic problems like insulin resistance, obesity, or high blood lipids. Think of the liver like a kitchen filter getting clogged with grease; over time that buildup can reduce function and lead to inflammation or scarring, which matters to investors because it signals a large, growing market for diagnostics, treatments, and related medical services.

ind-enabling studies regulatory

"Hoth plans to accelerate GDNF toward IND-enabling studies, targeting clinical trials in 2027"

Ind-enabling studies are early research efforts that test whether a new drug or treatment is safe and effective enough to move forward in development. They are like preliminary tests to ensure a product works as intended before investing more resources into large-scale trials. For investors, these studies are important because successful results can signal potential progress toward bringing a new product to market, impacting its future value.

orphan drug designation regulatory

"HT-KIT (Orphan Drug Designation for mast cell cancers)"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

egfr inhibitors medical

"HT-001 (Phase 2 for cancer-related skin toxicities), HT-KIT ... EGFR inhibitors"

Drugs that block the epidermal growth factor receptor (EGFR), a protein on some cells that can act like a stuck “go” switch telling cells to grow and divide; by turning that switch off, these medicines can slow or stop tumor growth in certain cancers. Investors watch EGFR inhibitors because clinical trial results, regulatory approvals, safety issues and competition directly affect a drugmaker’s future sales, valuation and risk, much like a new product’s success or failure shapes a company’s prospects.

AI-generated analysis. Not financial advice.

In a head-to-head preclinical comparison, HT-VA co-developed with the United States Veterans Administration GDNF demonstrated superior efficacy compared with semaglutide (the active ingredient in Wegovy®️ and Ozempic®️) across key metrics, including weight stabilization, glucose tolerance, liver weight reduction, and adipose tissue control—particularly in female models

NEW YORK, Feb. 10, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company developing innovative therapies for unmet medical needs, today announced compelling preclinical data from its VA-backed study on glial cell-derived neurotrophic factor (GDNF) as a novel treatment for obesity and metabolic-associated steatotic liver disease (MASLD). In a head-to-head comparison, GDNF demonstrated superior efficacy over semaglutide (the active ingredient in Wegovy® and Ozempic®) in key metrics, including weight stabilization, glucose tolerance, liver weight reduction, and adipose tissue control—particularly in female models.

This breakthrough positions GDNF as a potential gamechanger in the $200 billion obesity market, offering a differentiated mechanism that could address limitations of current GLP-1 agonists like gastrointestinal side effects and muscle loss. With obesity affecting over 1 billion people globally and MASLD impacting up to 30% of adults, GDNF's multi-faceted benefits could revolutionize treatment paradigms.

Key Study Highlights:

• Superior Weight Management: In female mice on a high-fat Western diet, GDNF attenuated weight gain by 10-15%, leading to a plateau in the final weeks of treatment—unlike semaglutide, which showed no significant impact. Researchers noted that higher doses or longer durations could amplify GDNF's effects, suggesting even greater potential for sustained weight loss.
• Enhanced Glucose Metabolism: GDNF fully normalized fasting glucose and improved overall response to glucose challenges, outperforming semaglutide in females. Baseline improvements were also seen in males, indicating broad metabolic benefits.
• Liver and Adipose Health: GDNF reduced liver weight by 20-30% and prevented adipose tissue accumulation in females, surpassing semaglutide's effects. This underscores GDNF's promise in resolving fatty liver disease, a common complication of obesity.
• Study Design: Conducted at the Srinivasan Lab with VA support, the 12-week study used CF-1 mice to model human obesity. GDNF was administered subcutaneously with escalating doses (2-12 µg/mouse), compared to semaglutide (12 ng/g/mouse).

"These results are a monumental step forward for Hoth and the fight against obesity," said Robb Knie, CEO of Hoth Therapeutics. "GDNF not only matched but exceeded semaglutide in critical areas, opening doors to a new era of safer, more effective therapies. As we advance this program, we're excited about its potential to deliver life-changing outcomes for patients and significant value for our shareholders."

The study builds on prior research showing GDNF's protective role against diet-induced obesity. Future analyses will include liver pathology, lipid content, and gene/protein expression to further elucidate mechanisms. Hoth plans to accelerate GDNF toward IND-enabling studies, targeting clinical trials in 2027.

Hoth's GDNF program is part of a robust pipeline, including HT-001 (Phase 2 for cancer-related skin toxicities), HT-KIT (Orphan Drug Designation for mast cell cancers), and HT-ALZ (for Alzheimer's).

About Hoth Therapeutics, Inc.

Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/.

Forward-Looking Statement
This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms, or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.

Investor Contact:
LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791

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SOURCE Hoth Therapeutics, Inc.

FAQ

What did Hoth (HOTH) announce about HT-VA GDNF on February 10, 2026?

Hoth announced preclinical VA-backed data showing HT-VA GDNF outperformed semaglutide on several metabolic endpoints. According to the company, benefits included female weight stabilization (10–15% attenuation), normalized fasting glucose, and 20–30% liver weight reduction in a 12-week mouse study.

How did HT-VA GDNF compare to semaglutide in the Hoth preclinical study (HOTH)?

In the head-to-head mouse study, GDNF showed superior effects on weight, glucose, and liver metrics versus semaglutide. According to the company, GDNF attenuated female weight gain, fully normalized fasting glucose, and reduced liver weight by 20–30%.

What timeline did Hoth (HOTH) provide for advancing the GDNF program?

Hoth plans to accelerate GDNF toward IND-enabling studies with an aim for clinical trials in 2027. According to the company, additional preclinical analyses (liver pathology, lipids, gene/protein expression) will inform the IND-enabling package.

What specific metabolic benefits did HT-VA GDNF show in the 12-week mouse model?

GDNF demonstrated female weight attenuation of 10–15%, full normalization of fasting glucose, improved glucose challenge responses, and 20–30% liver weight reduction. According to the company, adipose accumulation was also prevented in female mice versus semaglutide.

What are the main limitations of Hoth's HT-VA GDNF results for investors considering HOTH?

The findings come from a 12-week CF-1 mouse study and are preclinical, so human efficacy and safety remain unproven. According to the company, further pathology and molecular analyses are pending before IND-enabling decisions and clinical evaluation.