Hoth Therapeutics Delivers 100% Clinical Response with ~50% Reduction in Disease Severity in Open-Label PK Cohort of EGFR-Treated Cancer Patients

Rhea-AI Summary

Hoth Therapeutics (NASDAQ: HOTH) reported positive interim results from the open-label PK cohort of CLEER-001 evaluating HT-001 in cancer patients receiving EGFR inhibitors on Jan 22, 2026. Mean ARIGA scores improved from 1.67 to 0.83 by Week 6 (~50% reduction), with 100% of evaluable patients reaching low-severity disease (ARIGA ≤1). Investigator-assessed CTCAE improved from 2.0 to 1.33 (~34% improvement) and patient-reported pruritus fell from 4.22 to 2.67 (~37% reduction). HT-001 was well tolerated with no unexpected safety signals, supporting the selected dosing and continued development.

Positive

• 100% clinical response by Week 6 in evaluable patients
• ARIGA severity reduced ~50% (1.67 to 0.83) by Week 6
• CTCAE toxicity improved ~34% (2.0 to 1.33) at Week 6
• Patient-reported pruritus reduced ~37% (4.22 to 2.67)
• No unexpected safety signals; dosing PK supported

Negative

• None.

News Market Reaction

%

2 alerts

% News Effect

$16M Market Cap

0.4x Rel. Volume

On the day this news was published, HOTH declined NaN%, reflecting a moderate negative market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Clinical response rate: 100% of evaluable patients ARIGA reduction: ~50% reduction CTCAE improvement: ~34% improvement +5 more

8 metrics

Clinical response rate 100% of evaluable patients Open-label PK cohort clinical response by Week 6

ARIGA reduction ~50% reduction Primary endpoint disease severity improvement by Week 6

CTCAE improvement ~34% improvement Investigator-assessed oncology toxicity from baseline to Week 6

Pruritus reduction ~37% reduction Patient-reported pruritus severity from baseline to Week 6

ARIGA scores 1.67 to 0.83 Mean ARIGA from baseline to Week 6 in CLEER-001

CTCAE scores 2.0 to 1.33 Mean treatment-related toxicity from baseline to Week 6

Pruritus scores 4.22 to 2.67 Mean patient-reported NRS pruritus from baseline to Week 6

Shelf capacity $50 million Mixed shelf registration primary offering amount on Form S-3

Market Reality Check

Price: $1.04 Vol: Volume 4,546,110 is 8.81x...

high vol

$1.04 Last Close

Volume Volume 4,546,110 is 8.81x the 20-day average of 516,111, signaling unusually heavy trading ahead of and around this update. high

Technical Shares at $1.05 are trading below the 200-day MA at $1.22, and sit about 50% under the 52-week high.

Peers on Argus

HOTH fell 1.87% while peers showed mixed moves: LSTA up 84.26% in momentum scans...

1 Up

HOTH fell 1.87% while peers showed mixed moves: LSTA up 84.26% in momentum scans, QTTB up 8.01%, but ELEV, CRIS, and PASG down between 2.28% and 8.95%. This pattern points to stock-specific trading rather than a broad biotech move.

Historical Context

5 past events · Latest: Jan 15 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 15	Trial approvals	Positive	+3.4%	IRB approvals and cash update for HT-001 Phase 2a trial.
Jan 15	EU regulatory step	Positive	+3.4%	Positive EU CTIS Part I conclusion enabling multi-country oncology trial.
Jan 02	IP expansion	Positive	+8.1%	Provisional patents expanding HT-001 oncology dermatology platform.
Dec 03	Pipeline update	Positive	+5.3%	Comprehensive pipeline progress including HT-001, HT-KIT, HT-ALZ, GDNF program.
Dec 01	Conference appearance	Neutral	-5.8%	CEO presentation at NobleCon emerging growth equity conference.

Pattern Detected

Recent clinically and regulatorily positive updates for HT-001 and the broader pipeline have generally coincided with positive share reactions, with conference-related news the main negative outlier.

Recent Company History

Over the past few months, Hoth has steadily advanced HT-001 and its oncology platform. On Dec 3, 2025, a broad pipeline update highlighted Phase 2 CLEER-001 progress and multiple programs, with shares up 5.26%. Earlier, on Jan 2, 2026, dual provisional oncology dermatology patents for HT-001 preceded an 8.08% gain. Mid-January brought EU CTIS Part I clearance and IRB approvals for the Phase 2a trial, each linked to a 3.35% rise. A conference appearance on Dec 1, 2025 saw a -5.79% move, diverging from otherwise positive clinical/regulatory reactions.

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 mixed shelf on Form S-3 filed Nov 14, 2025 allows Hoth to register up to $50 million of various securities, plus resale of registered shares, via a base prospectus and future supplements. This structure gives the company flexibility to raise capital or issue securities over time as it advances its clinical pipeline.

Market Pulse Summary

This announcement highlights robust interim CLEER-001 data for HT-001, with 100% clinical response a...

Analysis

This announcement highlights robust interim CLEER-001 data for HT-001, with 100% clinical response and sizable reductions in ARIGA, CTCAE, and pruritus scores by Week 6. It follows recent IRB and EU regulatory milestones for the same program, underscoring steady clinical execution. Investors may track forthcoming randomized data, durability of benefit, and any safety updates, while also monitoring capital strategy under the existing $50 million shelf and broader development progress across Hoth’s oncology-focused portfolio.

Key Terms

ctcae, egfr inhibitors, pruritus, pharmacokinetic (pk), +2 more

6 terms

ctcae medical

"Oncology Toxicity (CTCAE):Investigator-assessed CTCAE scores improved from 2.0 at baseline"

A standardized system used in clinical trials to describe and grade the severity of side effects and unwanted medical events. Think of it as a common severity ‘meter’ that lets researchers, regulators and investors compare how risky or tolerable a drug or treatment is across studies; clearer, higher-grade entries can signal greater safety concerns that may affect regulatory approval, timelines and a company’s financial outlook.

egfr inhibitors medical

"cancer patients receiving EGFR inhibitor therapy."

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.

pruritus medical

"Mean pruritus scores improved from 4.22 at baseline to 2.67 at Week 6"

Pruritus is the medical term for an unpleasant itch sensation that makes a person want to scratch, ranging from mild irritation to severe, persistent discomfort like an itch you can’t stop rubbing. For investors, it matters because it can be a key symptom or side effect in clinical trials, affect drug labeling and regulatory decisions, drive market demand for treatments, and signal safety or tolerability issues that influence a healthcare product’s commercial prospects.

pharmacokinetic (pk) medical

"positive interim results from the open-label pharmacokinetic (PK) cohort of its ongoing"

Pharmacokinetic (pk) describes how a substance, such as a medication or chemical, moves through and is processed by the body over time. It includes how the substance is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps assess the potential effectiveness, safety, and market success of new drugs or treatments.

oncology toxicity medical

"Oncology Toxicity (CTCAE):Investigator-assessed CTCAE scores improved"

Oncology toxicity describes the harmful side effects that cancer treatments can cause in patients, ranging from mild discomfort to life-threatening damage to organs or blood cells. Investors care because the severity and frequency of these toxic effects affect a drug’s chances of regulatory approval, required safety warnings, ongoing monitoring, and market adoption—similar to how a car with frequent breakdowns will sell less and cost more to support over time.

supportive-care therapy medical

"HT-001's potential to serve as an important oncology supportive-care therapy"

Supportive-care therapy is treatment given alongside primary medical care to prevent or ease symptoms, side effects and complications—think of it as a shock absorber that helps patients tolerate the main treatment and maintain daily function. For investors, these therapies matter because they create additional markets for drugs, devices and services, can change how widely and safely main treatments are used, affect healthcare costs and reimbursement, and influence long‑term revenue streams and adoption rates.

AI-generated analysis. Not financial advice.

Primary endpoint ARIGA improved by ~50% from baseline by Week 6, with all evaluable patients reaching low-severity disease; additional endpoints demonstrated ~34% improvement in oncology toxicity (CTCAE) and ~37% reduction in patient-reported pruritus.

NEW YORK, Jan. 22, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on advancing innovative therapies for cancer patients with significant unmet needs, today announced positive interim results from the open-label pharmacokinetic (PK) cohort of its ongoing CLEER-001 clinical trial evaluating HT-001 in cancer patients receiving EGFR inhibitor therapy.

In the open-label PK cohort, 100% of evaluable patients achieved clinical response by Week 6, accompanied by a ~50% reduction in investigator-assessed disease severity from baseline. In addition to the primary endpoint, supportive clinical endpoints showed meaningful improvements, including a ~34% improvement in oncology toxicity (CTCAE) and a ~37% reduction in patient-reported pruritus, highlighting a broad and consistent treatment effect across multiple clinically relevant measures.

Primary Endpoint: Marked Improvement in Disease Severity (ARIGA)

The primary endpoint of CLEER-001 assessed disease severity using the ARIGA scale. In the open-label PK cohort, mean ARIGA scores improved from 1.67 at baseline to 0.83 at Week 6, representing an approximate 50% reduction in severity.

Importantly, all evaluable patients reached ARIGA ≤1 by Week 6, placing the entire evaluable cohort within the low-severity disease range. Improvements were observed as early as Week 3 and were maintained through Week 6, demonstrating both rapid onset and durability of response.

Additional Endpoints: Improvement in Oncology Toxicity and Patient-Reported Symptoms

Beyond the primary endpoint, HT-001 demonstrated meaningful improvements across additional clinically relevant endpoints:

• Oncology Toxicity (CTCAE):
  Investigator-assessed CTCAE scores improved from 2.0 at baseline to 1.33 at Week 6, representing an approximate 34% improvement in treatment-related toxicity. CTCAE is a core oncology toxicity scale frequently used to guide dose modification, interruption, or discontinuation of cancer therapies.
• Pruritus (Patient-Reported NRS):
  Mean pruritus scores improved from 4.22 at baseline to 2.67 at Week 6, representing approximate 37% reduction in symptom severity. This level of improvement exceeds commonly accepted thresholds for clinically meaningful benefit and is directly relevant to patient comfort, quality of life, and treatment adherence.

Favorable Tolerability and PK-Supported Dosing

HT-001 was well tolerated in the open-label PK cohort, with no unexpected safety signals observed. The PK portion of CLEER-001 was designed to evaluate exposure, tolerability, and early clinical signal, and the observed consistent improvements across investigator-assessed and patient-reported endpoints support the selected dosing regimen and continued clinical development.

Oncology Context and Unmet Need

EGFR inhibitors are cornerstone therapies across multiple major cancer indications, including lung, colorectal, and head-and-neck cancers. However, treatment-related toxicity and symptom burden remain among the most common and dose-limiting challenges, often impacting treatment continuity and outcomes. The CLEER-001 results highlight HT-001's potential to serve as an important oncology supportive-care therapy, helping patients remain on effective, life-extending cancer treatments.

Management Commentary

"These results represent a meaningful milestone for HT-001," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Seeing 100% clinical response in the open-label PK cohort, along with a ~50% reduction in disease severity and additional improvements in oncology toxicity and patient-reported symptoms, underscores the potential of HT-001 to improve the treatment experience for cancer patients receiving EGFR inhibitors. We are encouraged by the breadth and consistency of these findings as the CLEER-001 trial continues."

About HT-001

HT-001 is Hoth Therapeutics' proprietary topical therapy under investigation for the management of treatment-related toxicity and symptom burden in cancer patients receiving targeted therapies, including EGFR inhibitors.

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 were the Week 6 ARIGA results for HT-001 in CLEER-001 (HOTH)?

Mean ARIGA improved from 1.67 to 0.83 by Week 6, an approximate 50% reduction; all evaluable patients reached ARIGA ≤1.

How did HT-001 affect oncology toxicity (CTCAE) in the open-label PK cohort for HOTH?

Investigator-assessed CTCAE scores improved from 2.0 to 1.33 by Week 6, about a 34% improvement.

What change in pruritus did patients report after HT-001 treatment in CLEER-001?

Mean patient-reported pruritus fell from 4.22 to 2.67 by Week 6, an approximate 37% reduction.

Did Hoth report any safety concerns for HT-001 in the PK cohort?

HT-001 was reported as well tolerated with no unexpected safety signals in the open-label PK cohort.

When were these CLEER-001 interim PK cohort results for HOTH announced?

The interim open-label PK cohort results were announced on January 22, 2026.

What is the clinical significance of HT-001 results for patients on EGFR inhibitors (HOTH)?

Results showed rapid, durable reductions in disease severity and symptoms that may support continued dosing and further development of HT-001 as an oncology supportive-care therapy.