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Hoth Therapeutics (HOTH) Reports Positive HT-VA CRADA Data: GDNF Reprograms Liver Fat Metabolism, Shuts Down Fat-Creation Gene and Activates Fat-Burning Pathways, Outperforming Semaglutide

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Hoth Therapeutics (NASDAQ: HOTH) reported positive preclinical HT-VA CRADA data on April 13, 2026, showing parenteral GDNF reprograms liver fat metabolism at the genetic level.

Key findings include a statistically significant reduction in Srebf1 (lipogenesis), increased Pparα expression (fat burning), and gene-marker outperformance versus semaglutide. Hoth plans further preclinical validation and evaluation of clinical development and partnerships.

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Positive

  • Statistically significant reduction in Srebf1 (fat-creation gene)
  • Increased Pparα expression indicating enhanced fat metabolism
  • GDNF outperformed semaglutide on key liver gene-expression markers
  • Differentiated, dual mechanism targeting both lipogenesis suppression and fat burning

Negative

  • Results are limited to preclinical HT-VA model; clinical efficacy unproven
  • No clinical timelines or human safety/efficacy data disclosed
  • No quantitative magnitude of gene changes or metabolic endpoints provided

News Market Reaction – HOTH

+26.18% 16.5x vol
44 alerts
+26.18% News Effect
+69.4% Peak Tracked
-9.3% Trough Tracked
+$2M Valuation Impact
$9.86M Market Cap
16.5x Rel. Volume

On the day this news was published, HOTH gained 26.18%, reflecting a significant positive market reaction. Argus tracked a peak move of +69.4% during that session. Argus tracked a trough of -9.3% from its starting point during tracking. Our momentum scanner triggered 44 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $9.86M at that time. Trading volume was exceptionally heavy at 16.5x the daily average, suggesting very strong buying interest.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

2025 net loss: $12.5 million 2024 net loss: $8.2 million Accumulated deficit: $72.9 million +5 more
8 metrics
2025 net loss $12.5 million Full year 2025 net loss from 10-K
2024 net loss $8.2 million Full year 2024 net loss from 10-K
Accumulated deficit $72.9 million As of Dec 31, 2025 per 10-K
Q3 2025 net loss $4.11 million Quarter ended Sep 30, 2025 from 10-Q
Cash balance $7.85 million Cash and equivalents as of Sep 30, 2025
Shelf capacity $50 million Maximum primary offerings under Form S-3 shelf
ATM expansion $4,821,200 Common stock capacity under amended ATM program
Recent offering proceeds $2.0 million Gross from 2,857,144 shares at $0.70 in April 2026

Market Reality Check

Price: $0.6459 Vol: Volume 375,007 is below t...
normal vol
$0.6459 Last Close
Volume Volume 375,007 is below the 20-day average of 517,535 (relative volume 0.72), suggesting limited pre-news positioning. normal
Technical Shares at 0.5119 are trading below the 200-day MA of 1.2 and sit close to the 52-week low of 0.5 and far from the 2.115 high.

Peers on Argus

Peer biotech names show mixed moves, with declines in LSTA (-0.2%) and ELEV (-2....

Peer biotech names show mixed moves, with declines in LSTA (-0.2%) and ELEV (-2.28%) but strong gains in CRIS (+23.98%), PASG (+9.63%) and QTTB (+7.55%). No peers appeared in the momentum scanner, supporting a stock-specific read on the HOTH news.

Historical Context

5 past events · Latest: Apr 02 (Negative)
Pattern 5 events
Date Event Sentiment Move Catalyst
Apr 02 Equity offering closed Negative +3.0% Closing of $2.0M registered direct equity offering and warrants.
Apr 01 Equity offering announced Negative -34.9% Announcement of $2.0M registered direct offering and private warrants.
Apr 01 HT-001 interim results Positive -34.9% Phase 2 interim analysis met primary endpoint with strong symptom relief.
Mar 31 Chinese patent grant Positive +9.1% China granted patent protecting mast cell apoptosis technology to 2039.
Mar 26 AI platform launch Positive -6.7% Deployment of OpenClaw AI platform to accelerate drug discovery pipeline.
Pattern Detected

Recent history shows frequent divergences: positive clinical or strategic news has sometimes been followed by sharp declines, while dilutive offerings have seen both drops and rebounds.

Recent Company History

Over the past weeks, Hoth combined financing activity with clinical and strategic updates. A $2.0M registered direct offering and concurrent warrants were announced and then closed in early April 2026, with sharply negative and then mildly positive price reactions. A Phase 2 HT-001 interim analysis met its primary endpoint with >65% of patients reporting symptom relief, yet the stock fell about 34.86%. By contrast, a Chinese patent grant on Mar 31 saw a 9.12% gain. The new HT-VA metabolic data adds another program milestone to this mixed reaction pattern.

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 allows Hoth to offer up to $50 million of various securities, with at least one usage via a 424B5 prospectus on Apr 2, 2026. This framework enables additional capital raises through prospectus supplements, alongside prior ATM and registered direct activities noted in recent filings.

Market Pulse Summary

The stock surged +26.2% in the session following this news. A strong positive reaction aligns with t...
Analysis

The stock surged +26.2% in the session following this news. A strong positive reaction aligns with the clearly favorable genetic and mechanistic data around GDNF in MAFLD and obesity. Historically, Hoth’s newsflow has produced mixed price outcomes, with moves such as +9.12% on a Chinese patent but about -34.86% after positive HT-001 data. Investors would need to balance enthusiasm for differentiated metabolic biology against ongoing losses of $12.5 million in 2025 and a history of equity raises under the $50 million shelf.

Key Terms

crada, gdnf, mafld, nash, +4 more
8 terms
crada regulatory
"conducted under its Cooperative Research and Development Agreement (CRADA) with the U.S."
A CRADA (Cooperative Research and Development Agreement) is a formal partnership between a U.S. government research laboratory and a non‑government organization to work together on developing new technology or products while sharing expertise, facilities, and results. For investors, a CRADA can speed up development, lower costs and provide access to government-tested science — like a company teaming up with a well‑equipped public lab to borrow tools and know‑how, which can raise the chances of successful commercialization.
gdnf medical
"parenteral GDNF (Glial Cell-Derived Neurotrophic Factor) directly reprograms liver fat metabolism"
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.
mafld medical
"preclinical model of metabolic-associated fatty liver disease (MAFLD)"
MAFLD (Metabolic Associated Fatty Liver Disease) is a condition in which excess fat accumulates in the liver due to metabolic problems such as obesity, insulin resistance or diabetes rather than alcohol use. It matters to investors because it drives demand for diagnostic tests, drugs and healthcare services — like rust building up on an engine that eventually needs repair — and therefore influences the size and growth of related pharmaceutical, biotech and medical-device markets.
nash medical
"Entry into MAFLD/NASH and obesity markets"
Nonalcoholic steatohepatitis (NASH) is a progressive liver condition where excess fat and inflammation damage liver cells, similar to how rust and corrosion slowly weaken metal. It matters to investors because NASH affects a large, growing patient population and currently has limited approved treatments, so successful drugs or tests can unlock substantial commercial and regulatory value while clinical trial results and approvals drive company valuations.
glp-1 agonists medical
"differentiates GDNF from existing therapies, including GLP-1 agonists."
GLP-1 agonists are medicines that mimic a natural gut hormone to help the body release more insulin, slow stomach emptying and reduce appetite—think of them as turning up a thermostat that helps control blood sugar and curb hunger. They matter to investors because they can drive large prescription demand, influence healthcare costs and company profits, and are sensitive to clinical trial results, regulatory approvals, patent protection and pricing changes.
srebf1 medical
"Statistically significant reduction in Srebf1, a key gene driving fat production"
SREBF1 is a gene that makes a master switch protein controlling how cells produce fats and cholesterol, acting like a thermostat for the body’s lipid manufacturing. Investors care because drugs, diagnostics or crops that target this switch can affect treatments for metabolic diseases, weight-related conditions and certain cancers, so research breakthroughs or clinical results involving SREBF1 can influence the valuation and prospects of related companies.
pparα medical
"Increased expression of Pparα, a central regulator of fat metabolism"
A protein inside cells that controls genes involved in how the body handles fats and energy. It works like a thermostat or light switch for fat processing, so drugs that activate or block it can change cholesterol, triglyceride levels and overall metabolic health. Investors pay attention to PPARα because clinical trial results, approvals or safety concerns for therapies targeting it can materially affect a drug’s commercial prospects and the value of companies developing those medicines.
lipogenesis medical
"Reduced lipogenesis signaling (Srebf1) and enhanced metabolic regulation pathways"
Lipogenesis is the body's process of making and storing fat from excess calories, carried out mainly in the liver and fat tissue; think of it as the body’s fat-making factory that converts sugars and other nutrients into fat for later use. For investors, lipogenesis matters because drugs, diagnostics, or food products that alter this process can affect markets for obesity, diabetes, liver disease and metabolic health, influence safety profiles and regulatory approval, and serve as measurable biomarkers of treatment effect.

AI-generated analysis. Not financial advice.

Statistically Significant Reduction in Srebf1 (Fat Production) and Increased Pparα (Fat Metabolism) Position GDNF as Next-Generation Therapy for MAFLD and Obesity

NEW YORK, April 13, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, today announced positive data from its HT-VA study, conducted under its Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs and Emory University, demonstrating that parenteral GDNF (Glial Cell-Derived Neurotrophic Factor) directly reprograms liver fat metabolism at the genetic level in a preclinical model of metabolic-associated fatty liver disease (MAFLD).

The data highlights statistically significant improvements in key genes responsible for fat production and fat metabolism, positioning GDNF as a potentially differentiated therapeutic approach targeting the root cause of fatty liver disease and metabolic dysfunction.

  • Statistically significant reduction in Srebf1, a key gene driving fat production in the liver
  • Increased expression of Pparα, a central regulator of fat metabolism and fat burning
  • GDNF outperformed semaglutide in key gene expression markers tied to liver fat regulation
  • Demonstrated broad metabolic impact at the genetic level, not just weight reduction

Unlike existing therapies that primarily focus on weight loss, GDNF directly targets the biological mechanisms responsible for fat accumulation in the liver.

  • Srebf1 reduction → less fat being created
  • Pparα activation → more fat being burned
  • Net effect → reprogramming of liver metabolism

This dual mechanism suggests GDNF may offer a disease-modifying approach for MAFLD, obesity, and related metabolic disorders.

"HT-VA represents a major milestone for Hoth as we expand into high-value metabolic indications," said Robb Knie, Chief Executive Officer of Hoth Therapeutics.

"These results demonstrate that GDNF is not simply reducing fat, but fundamentally reprogramming how the body produces and metabolizes fat at the genetic level. The ability to shut down fat creation while activating fat metabolism differentiates GDNF from existing therapies, including GLP-1 agonists."

SCIENTIFIC SUMMARY (HT-VA STUDY)

The HT-VA study evaluated the effects of parenteral GDNF in a diet-induced obesity and MAFLD model.

Key observations include:

  • Western diet significantly increased liver fat accumulation and metabolic dysfunction
  • GDNF treatment significantly improved liver gene expression linked to fat metabolism
  • Reduced lipogenesis signaling (Srebf1) and enhanced metabolic regulation pathways (Pparα)
  • Gene expression changes support improved hepatic lipid handling and metabolic efficiency

STRATEGIC IMPLICATIONS

  • Entry into MAFLD/NASH and obesity markets 
  • Differentiation vs. GLP-1 therapies through gene-level mechanism
  • Potential for first-in-class metabolic reprogramming therapy
  • Expansion beyond Hoth's core dermatology and oncology pipeline

NEXT STEPS

Hoth plans to:

  • Advance HT-VA findings into additional preclinical validation studies
  • Evaluate clinical development pathways for metabolic and liver diseases
  • Explore strategic partnerships and collaborations to accelerate development

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 on April 13, 2026 about GDNF and liver metabolism?

Hoth announced positive preclinical HT-VA data showing GDNF reprograms liver fat genes. According to the company, GDNF significantly reduced Srebf1 and increased Pparα versus controls, and outperformed semaglutide on key liver gene-expression markers in a diet-induced MAFLD model.

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

GDNF outperformed semaglutide on specific liver gene-expression markers tied to fat regulation. According to the company, GDNF showed stronger effects on Srebf1 reduction and Pparα activation in the preclinical MAFLD model.

Does Hoth's April 13, 2026 HT-VA data mean GDNF is ready for clinical use (HOTH)?

No, the data are preclinical and do not establish clinical safety or efficacy. According to the company, Hoth will pursue additional preclinical validation and evaluate clinical development pathways before human trials can begin.

What are the next steps Hoth (HOTH) plans after the HT-VA findings?

Hoth plans further preclinical validation and to evaluate clinical development and partnerships. According to the company, they will explore strategic collaborations to accelerate development for metabolic and liver indications.

What mechanism did Hoth report for GDNF in the HT-VA study (HOTH)?

GDNF reportedly suppresses fat-creation genes and activates fat-burning pathways in the liver. According to the company, reduced Srebf1 lowers lipogenesis while increased Pparα enhances hepatic fat metabolism, indicating metabolic reprogramming.

How might Hoth's (HOTH) GDNF data affect its therapeutic strategy beyond dermatology and oncology?

The data support expansion into MAFLD, NASH, and obesity indications with a potential differentiated approach. According to the company, GDNF's gene-level mechanism could position it as a first-in-class metabolic reprogramming therapy pending further validation.