HOTH THERAPEUTICS ACCELERATES HT-001 TRIAL ENROLLMENT WITH NEW CLINICAL SITE AS PATIENT DEMAND INCREASES

Hoth Therapeutics (NASDAQ: HOTH) announced expansion of its CLEER-001 Phase 2a trial with a new enrolling site, Regis Clinical Research in Miami, on Feb 24, 2026.

Rhea-AI Summary

Hoth Therapeutics (NASDAQ: HOTH) announced expansion of its CLEER-001 Phase 2a trial with a new enrolling site, Regis Clinical Research in Miami, on Feb 24, 2026.

Interim data show 100% of open-label cohort met the primary ARIGA ≤1 endpoint by week six, 0 dose reductions, >65% meaningful pain/itch relief, and 0 dose-limiting toxicities; the company said the new site will speed enrollment and data collection.

Positive

• 100% of open-label cohort met ARIGA ≤1 by week six
• 0 patients required EGFRi dose reduction or discontinuation
• >65% of patients reported meaningful reductions in pain and itching
• 0 dose-limiting toxicities observed to date
• New Miami site adds IRB-approved, FDA-compliant research infrastructure

Negative

• Data are interim and from an open-label cohort, not yet definitive for approval

Argus Feb 25 session

+4.95% close to close Open Argus

Details

News Market Reaction – HOTH

On Feb 25, the first trading day after this news, HOTH closed 4.95% above the previous close.

Data tracked by StockTitan Argus for the Feb 25 session.

Market Context

This announcement highlights accelerating demand for HT-001 in the CLEER-001 Phase 2a trial, with in...

Analysis

This announcement highlights accelerating demand for HT-001 in the CLEER-001 Phase 2a trial, with interim data showing 100% of open-label patients meeting the primary endpoint and no dose-limiting toxicities. It follows earlier positive oncology and obesity updates and sits against a balance sheet with $7.85 million in cash and an effective $50 million shelf for future financing. Investors may watch for the full CLEER-001 data set, additional site expansions, and any new use of the shelf registration.

Key Figures

Annual EGFRi patients: 200,000 Americans Primary endpoint response: 100% of open-label cohort Symptom relief rate: Over 65% of patients +5 more

Annual EGFRi patients

200,000 Americans

Estimated yearly EGFR inhibitor-treated cancer patients in U.S.

Primary endpoint response

100% of open-label cohort

Achieved ARIGA rash score ≤1 by week six on HT-001

Symptom relief rate

Over 65% of patients

Reported meaningful reductions in pain and itching on HT-001

Dose-limiting toxicities

Zero observed

No dose-limiting toxicities across CLEER-001 trial to date

Shelf registration size

$50 million

Mixed shelf on Form S-3 for primary offerings

Net loss

$4.11 million

Q3 2025 net loss from 10-Q filing

Cash balance

$7.85 million

Cash and cash equivalents as of Sept 30, 2025

Shares outstanding

15,514,312 shares

Common stock outstanding as of Nov 10, 2025

Historical Context

5 past events · Latest: Feb 12

5 events

1. Feb 12

   Patent allowance

   24h Move

   +5.2%

   USPTO Notice of Allowance for dual‑mechanism allergic disease patent.

2. Feb 10

   Preclinical obesity data

   24h Move

   +10.7%

   HT-VA GDNF outperformed semaglutide in 12-week obesity mouse model.

3. Feb 05

   Crypto exposure update

   24h Move

   -4.0%

   Company clarified no material cryptocurrency holdings and reaffirmed R&D focus.

4. Jan 22

   HT-001 interim data

   24h Move

   +0.0%

   CLEER-001 interim results showed 100% low-severity rash response and good tolerability.

5. Jan 21

   China oncology patent

   24h Move

   -1.9%

   China patent granted for HT-KIT cancer program, expanding global IP protection.

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

Key Terms

phase 2a, egfr inhibitor, primary efficacy endpoint, open-label cohort, +4 more

8 terms

phase 2a medical

"CLEER-001 Phase 2a clinical trial with the addition of Regis"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

egfr inhibitor medical

"For the estimated 200,000 Americans who begin EGFR Inhibitor cancer therapy"

An epidermal growth factor receptor (EGFR) inhibitor is a medicine that blocks a specific protein on some cancer cells that acts like a ‘on’ switch for growth; by turning that switch off, the drug can slow or stop tumor growth. Investors care because these drugs are often tied to clear clinical tests, targeted patient groups, patent-protected sales and regulatory decisions, so trial results, safety issues or approvals can sharply change a company’s value.

primary efficacy endpoint medical

"100% of open-label cohort patients achieved the primary efficacy endpoint"

The primary efficacy endpoint is the single main result a clinical trial is designed to measure to decide whether a treatment works, chosen before the study starts. Think of it as the official scoreboard metric judges use to declare a win or loss; investors watch it because meeting or missing this pre-set goal usually drives regulatory approval odds, market expectations, and a company’s stock value.

open-label cohort medical

"100% of open-label cohort patients achieved the primary efficacy endpoint"

An open-label cohort is a group of trial participants who and whose doctors know which treatment they are receiving rather than being kept blind. Investors care because results from open-label groups can show how a medicine works in real-world conditions but are more prone to expectation and observer effects, so data from these cohorts often carry different weight when assessing a drug’s effectiveness and regulatory or commercial prospects.

dose-limiting toxicities medical

"Zero dose-limiting toxicities observed across the entire trial to date"

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.

irb-approved regulatory

"Regis Clinical Research brings IRB-approved, FDA-compliant research infrastructure"

IRB-approved means a research study involving people has been reviewed and given permission by an independent committee that checks for participant safety, ethical treatment, and clear consent — like a safety inspector signing off on a building plan. For investors, this signals that the study meets basic regulatory and ethical standards, lowering the chance of regulatory setbacks and increasing confidence that results can be collected and reported as planned.

fda-approved regulatory

"patients have no FDA-approved treatment option. HT-001 is designed to change that"

FDA-approved means a medical product, drug, device or treatment has passed the U.S. Food and Drug Administration’s review for safety and effectiveness for a specific use. Think of it like a formal safety and performance seal that allows the product to be marketed for that purpose in the U.S.; for investors, approval reduces regulatory uncertainty, enables sales and reimbursement pathways, and can materially affect a company’s revenue prospects and valuation.

clinical trial medical

"Regis joins the growing CLEER-001 investigational site network"

A clinical trial is a carefully controlled study in which a new medicine, medical device, or treatment is tested on people to see if it is safe and effective. For investors it matters because trial results determine whether a product can win regulatory approval and reach patients, much like a road test decides if a new car can be sold; positive or negative results can sharply change a company’s prospects and stock value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

CLEER-001 Phase 2a Expansion Signals Growing Momentum Behind First-in-Class Therapy for Cancer Patients With No Current FDA-Approved Treatment Option

NEW YORK, Feb. 24, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH) today announced a significant expansion of its CLEER-001 Phase 2a clinical trial with the addition of Regis Clinical Research as a new enrolling site. Located in Miami, Florida, Regis joins the growing CLEER-001 investigational site network as surging patient demand outpaces capacity at existing sites — a direct reflection of the compelling early clinical results HT-001 has produced and the desperate unmet need it addresses.

For the estimated 200,000 Americans who begin EGFR Inhibitor cancer therapy each year, the skin toxicities that accompany treatment are not a minor inconvenience. They are severe, often disfiguring rashes, lesions, and unrelenting itch that force up to one-third of patients to reduce or discontinue the chemotherapy keeping them alive. Today, those patients have no FDA-approved treatment option. HT-001 is designed to change that — and the data so far suggests it can.

Positive Signal

The interim CLEER-001 data is generating physician and patient interest that drives enrollment expansions like today's announcement:

• 100% of open-label cohort patients achieved the primary efficacy endpoint — an ARIGA rash severity score of ≤1 — by week six
• Zero patients required dose reduction or discontinuation of their life-saving EGFRi cancer therapy while on HT-001
• Over 65% of patients reported meaningful reductions in pain and itching
• Zero dose-limiting toxicities observed across the entire trial to date
• At the American Academy of Dermatology Annual Meeting, a case study demonstrated complete lesion and symptom resolution after just one week of twice-daily application in a metastatic breast cancer patient

For a patient population that currently has no targeted treatment, results like these represent a potential paradigm shift in how oncologists can manage one of the most common and quality-of-life-destroying side effects in all of cancer care.

A New Site, A New Market, A Growing Network

Regis Clinical Research brings IRB-approved, FDA-compliant research infrastructure and a new South Florida patient population to the CLEER-001 network. For Hoth, it means faster enrollment, a faster path to a complete data set, and a faster road to the regulatory milestones that matter.

"The addition of Regis Clinical Research is a direct response to the acceleration we are seeing in enrollment demand," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "The data speaks for itself. Patients and oncologists are taking notice — and we are building the infrastructure to meet that demand and deliver the full clinical readout this program deserves."

Patients and referring physicians may visit regisclinical.com or call +1 (305) 546-3952 to learn more about participation in the CLEER-001 trial.

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

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/hoth-therapeutics-accelerates-ht-001-trial-enrollment-with-new-clinical-site-as-patient-demand-increases-302696240.html

SOURCE Hoth Therapeutics, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Hoth Therapeutics (HOTH) announce on February 24, 2026 about CLEER-001?

Hoth announced addition of Regis Clinical Research as a new enrolling site for CLEER-001 to accelerate Phase 2a enrollment. According to the company, the site in Miami expands patient access and aims to speed completion of the trial and regulatory-readout timelines.

What interim CLEER-001 results did Hoth (HOTH) report for HT-001 as of Feb 24, 2026?

Interim results showed 100% of the open-label cohort reached ARIGA rash severity ≤1 by week six. According to the company, zero patients needed EGFRi dose reductions, >65% had meaningful symptom relief, and no dose-limiting toxicities were observed.

How will the Regis Clinical Research site affect CLEER-001 enrollment for Hoth (HOTH)?

The Regis site will increase enrollment capacity and patient access in South Florida to meet rising demand. According to the company, adding IRB-approved, FDA-compliant infrastructure should shorten enrollment timelines and accelerate data collection for the Phase 2a program.

What is HT-001 intended to treat and which patients are targeted by Hoth (HOTH)?

HT-001 is designed to treat EGFR inhibitor–related skin toxicities that currently lack FDA-approved therapies. According to the company, it targets cancer patients experiencing severe rashes, lesions, pain, and itching from EGFRi cancer treatments.

How can patients or physicians learn about joining the CLEER-001 trial (HOTH)?

Patients and referring physicians can contact Regis Clinical Research or visit regisclinical.com for participation details. According to the company, the Miami site phone number +1 (305) 546-3952 is available for screening and enrollment information.

What safety findings did Hoth (HOTH) report for HT-001 in the CLEER-001 trial interim data?

The company reported no dose-limiting toxicities and no EGFRi dose reductions due to HT-001. According to the company, safety signals to date have been favorable, with zero patients requiring treatment interruption for toxicity.