Hoth Therapeutics Reports Positive HT-001 PK, Safety, and Clinical Activity Data in Cancer Patients with EGFR Therapy-Associated Skin Toxicities Showing ~77% Increase in Drug Exposure and Minimal Systemic Absorption

Rhea-AI Summary

Hoth Therapeutics (NASDAQ: HOTH) reported positive pharmacokinetic, safety, and clinical activity data for topical HT-001 on March 24, 2026. Key PK results: mean AUC₀–₂₄ rose to 80.60 h•ng/mL on Day 42 from 45.61 on Day 1 (~76.7% increase). Mean Cavg increased to 3.36 ng/mL and mean Cmax to 4.56 ng/mL. Accumulation ratios were RA_AUCτ ~2.09x and RA_Cmax ~1.72x. Systemic exposure remained minimal versus oral formulations (~0.2% Day 1, 0.5% Day 42). Safety: no serious adverse events, no dose-limiting toxicities, and no discontinuations due to adverse events. The company linked sustained exposure to observed symptom reductions and supports further development and dose optimization.

Positive

• AUC₀–₂₄ +76.7% to 80.60 h•ng/mL on Day 42
• Cavg +76.8% to 3.36 ng/mL supporting sustained exposure
• RA_AUCτ ~2.09x indicating repeat‑dose accumulation
• Minimal systemic exposure versus oral therapies (~0.2% Day 1, <0.5% Day 42)
• Favorable safety: 0% serious adverse events, no DLTs, no discontinuations

Negative

• Systemic absorption observed in a subset of subjects, indicating variable topical uptake
• Cmax increased ~48.5%, less than AUC and Cavg increases, suggesting differing peak versus overall exposure

News Market Reaction – HOTH

-5.03%

5 alerts

-5.03% Session close to close

+4.1% Peak Tracked

-10.2% Trough Tracked

$14.48M Market Cap

0.6x Rel. Volume

In the Mar 24 session, HOTH declined 5.03%, reflecting a notable negative market reaction. Argus tracked a peak move of +4.1% during that session. Argus tracked a trough of -10.2% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -5.0% in the session following this news. A negative reaction despite favorable HT-0...

Analysis

The stock moved -5.0% in the session following this news. A negative reaction despite favorable HT-001 pharmacokinetics and 0% serious adverse events would contrast with prior positive responses to clinical milestones. Pressure could reflect concerns about future financing needs under the existing $50 million shelf or broader biotech risk-off sentiment. Past news generally coincided with positive moves, so a sharp decline would represent a deviation from the recent pattern rather than a repeat of prior behavior.

Key Figures

AUC₀–₂₄ Day 1: 45.61 h•ng/mL AUC₀–₂₄ Day 42: 80.60 h•ng/mL Increase in exposure: 76.7% +5 more

8 metrics

AUC₀–₂₄ Day 1 45.61 h•ng/mL Mean systemic exposure on Day 1 PK analysis

AUC₀–₂₄ Day 42 80.60 h•ng/mL Mean systemic exposure on Day 42 PK analysis

Increase in exposure 76.7% Increase in mean AUC₀–₂₄ from Day 1 to Day 42

RA_AUCτ 2.09x Mean accumulation ratio for AUC across paired evaluable subjects

RA_Cmax 1.72x Mean accumulation ratio for Cmax across paired evaluable subjects

Serious adverse events 0% No serious adverse events reported in safety findings

Exposure vs oral Day 1 0.2% Systemic exposure relative to FDA-approved oral formulations on Day 1

Exposure vs oral Day 42 <0.5% Systemic exposure relative to FDA-approved oral formulations on Day 42

Historical Context

5 past events · Latest: Mar 10 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 10	MASLD preclinical data	Positive	+1.5%	Female mouse MASLD model showed cholesterol restoration and lipid improvements.
Mar 04	AI oncology update	Positive	+3.3%	HT-KIT development aided by OpenAI API with strong preclinical tumor suppression.
Feb 24	HT-001 trial expansion	Positive	+5.0%	New Phase 2a site added; interim CLEER-001 data met primary endpoint with good safety.
Feb 12	Patent allowance	Positive	+5.2%	USPTO notice of allowance for exon-skipping patent in allergic diseases.
Feb 10	Obesity model results	Positive	+10.7%	HT-VA outperformed semaglutide in weight, glucose control, and liver health model.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive scientific and regulatory updates have consistently coincided with positive 24-hour price reactions.

Recent Company History

Over recent months, Hoth has reported multiple positive developments, including HT-VA preclinical obesity data on Feb 10, a U.S. patent notice of allowance on Feb 12, HT-001 Phase 2a trial expansion with strong interim results on Feb 24, AI-enabled HT-KIT oncology progress on Mar 4, and MASLD preclinical data on Mar 10. Each update saw a positive next-day move, framing today’s HT-001 PK, safety, and clinical activity data within a pattern of constructive news flow.

Key Terms

pharmacokinetic, auc₀–₂₄, cavg, cmax, +4 more

8 terms

pharmacokinetic medical

"reported positive pharmacokinetic (PK), safety, and clinical activity data for HT-001"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

auc₀–₂₄ medical

"In the Company's PK analysis, mean AUC₀–₂₄ increased to 80.60 h•ng/mL on Day 42"

AUC₀–₂₄ (area under the concentration–time curve from 0 to 24 hours) measures the total amount of a drug or compound present in the bloodstream over a 24‑hour period after dosing. For investors, it’s a key way to gauge how much of a medicine the body actually sees—like measuring total rainfall over a day rather than peak intensity—so it helps assess expected effectiveness, safety risks, dosing frequency, and how a formulation or interaction might change a drug’s real-world performance.

cavg medical

"Mean Cavg increased to 3.36 ng/mL from 1.90 ng/mL (~76.8%)"

The average concentration of a drug in the bloodstream over a dosing interval, typically measured once dosing has reached a steady routine. Investors care because this number helps regulators and doctors judge whether a medicine is likely to be effective and safe at prescribed doses—similar to checking the average water level in a bathtub rather than just the highest splash, it gives a steady-picture of exposure that affects dosing decisions, side-effect risk, and ultimately commercial viability.

cmax medical

"while mean Cmax increased to 4.56 ng/mL from 3.07 ng/mL (~48.5%)"

Cmax is the highest concentration of a drug measured in the bloodstream after a dose, like the peak of a wave after a stone is dropped into water. It matters to investors because that peak helps regulators and doctors judge safety and likely effectiveness, informs dosing schedules, and is used to compare formulations or generics—data that can affect a drug’s approval, marketability, and commercial value.

systemic absorption medical

"PK studies of topical HT-001 reveal limited systemic absorption and ~99% reduced systemic levels"

Systemic absorption is when a drug or chemical applied locally (like on the skin, in the nose, or the gut) enters the bloodstream and can affect the whole body rather than just the application site. Investors care because higher or unexpected systemic absorption can change a product’s safety profile, dosing requirements, regulatory approval, and marketability—similar to a dye that was meant to stain a single spot but instead spreads through the entire stream.

dose-limiting toxicities medical

"Safety and tolerability findings included:No serious adverse events (0%)No dose-limiting toxicities observed."

Dose-limiting toxicities are the harmful side effects seen in early clinical trials that are severe enough to stop researchers from raising a drug’s dose. Like a car’s speed limiter marking the safe top speed, DLTs define the maximum tolerable dose, and they matter to investors because they determine whether a medicine can reach effective levels, influence development timelines, costs, and regulatory chances, and thus affect a drug’s commercial prospects.

plasma concentrations medical

"sustained plasma concentrations across the dosing interval."

Plasma concentrations measure how much of a drug or biological marker is present in the liquid part of blood at a given time, like how much sugar is dissolved in a glass of water. Investors care because these levels show whether a treatment reaches the body in the right amount to work safely and consistently; that information drives clinical success, regulatory approval, dosing decisions and commercial value.

topical delivery medical

"Systemic absorption was observed in a subset of subjects, consistent with topical delivery"

Topical delivery is the method of applying a drug or treatment directly onto a body surface—such as skin, eyes, or mucous membranes—so the medicine acts where it’s placed rather than being swallowed or injected. For investors, this matters because topical products often have different development costs, regulatory hurdles, manufacturing processes and market appeal than oral or injected drugs, influencing potential sales, competition and profit margins much like selling a ready-to-use paint versus a bulk raw material.

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PK studies of topical HT-001 reveal limited systemic absorption and ~99% reduced systemic levels as compared to FDA approved oral formulations.

Safety and tolerability findings included:

• No serious adverse events (0%)
• No dose-limiting toxicities observed.
• No treatment discontinuations due to adverse events

Day 42 Data Show Higher AUC, Cavg, and Cmax vs Day 1, with ~2.1x Accumulation Supporting Sustained Drug Exposure, Consistent Tolerability, and Clinically Meaningful Response

NEW YORK, March 24, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH) today reported positive pharmacokinetic (PK), safety, and clinical activity data for HT-001, demonstrating a ~77% increase in systemic drug exposure following repeat dosing, minimal systemic absorption relative to oral formulations, a favorable safety profile with no serious adverse events, and encouraging reductions in symptom severity.

In addition, HT-001 demonstrated encouraging clinical activity, with treated subjects exhibiting meaningful reductions in symptom severity and sustained response over the treatment period. These efficacy observations were consistent with the pharmacokinetic profile, suggesting that increased and sustained drug exposure may translate into improved clinical outcomes.

In the Company's PK analysis, mean AUC₀–₂₄ increased to 80.60 h•ng/mL on Day 42 from 45.61 h•ng/mL on Day 1, representing an approximate 76.7% increase in systemic exposure. Mean Cavg increased to 3.36 ng/mL from 1.90 ng/mL (~76.8%), while mean Cmax increased to 4.56 ng/mL from 3.07 ng/mL (~48.5%), demonstrating consistent, dose-dependent increases in drug exposure.

Mean and individual concentration-time profiles showed higher overall exposure at Day 42 compared to Day 1. Semilog analysis confirmed predictable elimination kinetics and sustained plasma concentrations across the dosing interval.

Importantly, systemic exposure following topical HT-001 remained minimal relative to oral formulations. On Day 1, exposure levels were approximately 0.2% of those observed with FDA-approved oral formulations, and remained below 0.5% on Day 42 despite repeated dosing.

Systemic absorption was observed in a subset of subjects, consistent with topical delivery, and remained low overall, supporting a favorable systemic safety profile.

Across paired evaluable subjects, the mean accumulation ratio (RA_AUCτ) was approximately 2.09x, with mean RA_Cmax of approximately 1.72x, supporting repeat-dose pharmacokinetic activity and sustained drug levels over time.

Safety and tolerability findings included:

• No serious adverse events (0%)
• No dose-limiting toxicities observed
• No treatment discontinuations due to adverse events

"These pharmacokinetic results, combined with a favorable safety and tolerability profile, support the continued advancement of HT-001," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "The approximately 77% increase in systemic exposure, along with consistent accumulation and minimal systemic absorption relative to oral therapies, reinforces our dosing strategy as we advance development."

The Company believes these data support continued clinical advancement and dose optimization, with PK findings aligning with observed clinical outcomes, including meaningful reductions in symptom severity and sustained patient response.

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 PK improvement did Hoth Therapeutics report for HT-001 on March 24, 2026 (HOTH)?

HT-001 showed an approximate 76.7% increase in AUC₀–₂₄ by Day 42. According to the company, mean AUC rose from 45.61 h•ng/mL on Day 1 to 80.60 h•ng/mL on Day 42, supporting sustained systemic exposure after repeat dosing.

How much systemic absorption did HT-001 show compared with oral formulations in HOTH's March 24, 2026 release?

Systemic exposure remained minimal versus oral drugs, about 0.2% on Day 1 and under 0.5% on Day 42. According to the company, topical HT-001 yields substantially lower systemic levels than FDA‑approved oral formulations.

What safety findings did Hoth Therapeutics report for HT-001 (HOTH) in the March 24, 2026 update?

HT-001 had a favorable safety profile with no serious adverse events, no dose-limiting toxicities, and no treatment discontinuations. According to the company, tolerability remained consistent across the repeat-dosing period.

Did Hoth Therapeutics observe pharmacokinetic accumulation for HT-001 in the March 24, 2026 data (HOTH)?

Yes. HT-001 showed repeat-dose accumulation with RA_AUCτ approximately 2.09x and RA_Cmax ~1.72x. According to the company, these ratios support sustained drug levels over the dosing interval after repeat application.

What clinical activity did Hoth Therapeutics report for HT-001 in patients with EGFR therapy-associated skin toxicities (HOTH)?

Treated subjects showed encouraging reductions in symptom severity and sustained responses during treatment. According to the company, observed clinical improvements were consistent with the increased and sustained PK exposure measured by Day 42.

How do Hoth Therapeutics' HT-001 PK findings affect the company's development plans (HOTH)?

The company said the PK and safety data support continued clinical advancement and dose optimization of HT-001. According to the company, the approximately 77% increase in exposure and tolerability reinforce their dosing strategy moving forward.