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Hoth Therapeutics Expands Oncology Pipeline with Dual Patent Filings Establishing Novel Oncology Dermatology IP Platform

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Hoth Therapeutics (NASDAQ: HOTH) announced on January 2, 2026 the filing of two U.S. provisional patent applications to expand its intellectual property into an oncology-focused dermatology platform.

The filings claim use of HT-001 to treat treatment-induced skin toxicities from radiation therapy and from emerging targeted cancer therapies (including second- and third-generation menin inhibitors), securing priority rights across multiple oncology modalities and formulations.

The company describes HT-001 as a receptor antagonist targeting neurogenic and inflammatory pathways and says the provisional filings support further preclinical work, formulation optimization, and potential future U.S. and international patent protection.

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Positive

  • Filed two U.S. provisional patents on Jan 2, 2026
  • Secures priority IP for HT-001 across radiation and targeted-therapy skin toxicities
  • Positions company in the growing oncology supportive-care/oncodermatology market

Negative

  • Provisional applications are not granted patents and provide temporary priority only
  • No clinical efficacy or outcome data for HT-001 in oncology dermatologic indications disclosed
  • Further preclinical development and formulation work is required before regulatory or commercial milestones

Key Figures

Provisional patents 2 applications Dual U.S. provisional oncology-dermatology filings for HT-001
Shelf registration size $50 million Mixed shelf on Form S-3 filed Nov 14, 2025
Resale shares 1,279,587 shares Shares registered for resale under S-3 shelf
Shares outstanding 15,514,312 shares Common stock outstanding as of Nov 10, 2025
Q3 2025 net loss $4.11 million Net loss for quarter ended Sep 30, 2025
Cash balance $7.85 million Cash and equivalents as of Sep 30, 2025

Market Reality Check

$1.07 Last Close
Volume Volume 196,051 is 1.39x the 20-day average of 140,612, indicating elevated trading interest pre-announcement. normal
Technical Shares at $0.99 are trading below the 200-day MA of $1.22 and about 74% under the 52-week high of $3.80.

Peers on Argus

Peers in Biotechnology showed mixed moves, with names like PASG up 12.92% and others such as LSTA and ELEV down modestly, suggesting HOTH’s setup around this IP news is more stock-specific than sector-driven.

Historical Context

Date Event Sentiment Move Catalyst
Dec 03 Pipeline update Positive +5.3% Broad clinical and preclinical pipeline progress across four key programs.
Dec 01 Conference presentation Neutral -5.8% CEO presentation at NobleCon emerging growth equity conference.
Nov 20 AI collaboration Positive -10.4% Acceptance into NVIDIA Connect Program to support AI-driven R&D.
Oct 27 Preclinical program launch Positive +1.1% VA-backed GDNF study targeting obesity and fatty liver disease.
Oct 21 Orphan designation Positive +3.6% FDA Orphan Drug Designation and strong preclinical data for HT-KIT.
Pattern Detected

News around pipeline and regulatory progress has often seen positive price alignment, though the NVIDIA AI collaboration drew a notable negative divergence.

Recent Company History

Over the last few months, Hoth reported multiple R&D and strategic updates, including FDA Orphan Drug Designation and strong preclinical data for HT-KIT on Oct 21, 2025, a VA-backed GDNF obesity program launch on Oct 27, 2025, and acceptance into the NVIDIA Connect Program on Nov 20, 2025. A broad pipeline update on Dec 3, 2025 highlighted progress for HT-001, HT-KIT, HT-ALZ, and the GDNF program. Today’s dual oncology-dermatology patent filings for HT-001 extend this pattern of IP-focused, pipeline-building announcements.

Regulatory & Risk Context

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 offer up to $50 million of various securities over time, plus resale of 1,279,587 shares by a selling shareholder. With 0 recorded usages so far and the shelf not yet effective, it still represents future capacity for potential equity or debt issuance that could impact existing shareholders depending on how it is utilized.

Market Pulse Summary

This announcement adds two U.S. provisional patents around HT-001, positioning it as a platform for treating radiation- and targeted-therapy–induced skin toxicities in oncology. It builds on prior updates highlighting a diversified, IP-heavy pipeline spanning HT-001, HT-KIT, HT-ALZ, and a GDNF metabolic program. Investors may focus on how this oncodermatology platform scales, future clinical-readout timing, the company’s cash of $7.85 million, and the existing $50 million shelf when assessing execution risk.

Key Terms

radiation-induced skin toxicity medical
"covering the topical treatment of radiation-induced skin toxicity in oncology patients"
Radiation-induced skin toxicity is the damage and inflammation that can occur to the skin when it is exposed to therapeutic radiation, ranging from mild redness and peeling to painful ulcers and infection. Investors should care because its incidence and severity affect how well cancer treatments are tolerated, can influence regulatory safety assessments, clinical trial results, adoption by doctors and patients, and potential costs for supportive care or product warnings—similar to how a product’s side effects shape customer acceptance and liability.
dermatologic toxicities medical
"addressing dermatologic toxicities associated with emerging targeted cancer therapies"
Dermatologic toxicities are skin-related side effects caused by a medicine or medical treatment, ranging from mild rashes and dryness to more severe inflammation or blistering. For investors, these effects matter because they shape a drug’s safety profile, can delay or change regulatory approval, lead to additional treatment costs or warning labels, and influence how widely doctors and patients will use the product—like visible warning lights that can limit a car’s saleability.
menin inhibitors medical
"including second and third menin inhibitors"
Menin inhibitors are medicines that block the activity of the menin protein, which acts like a key connector that helps certain cancer cells turn on growth programs. By disrupting that connection, these drugs can slow or stop tumors that rely on menin-driven pathways from growing. Investors care because menin inhibitors represent a targeted drug class with potential to address hard-to-treat blood cancers; clinical trial results, regulatory approval, and commercial uptake drive value and risk.
receptor antagonist medical
"use of HT-001, a receptor antagonist with a well-established pharmacologic profile"
A receptor antagonist is a drug or molecule that attaches to a specific site on a cell and prevents that site from being turned on by the body’s own chemicals; think of it as putting a cap on a lock so the key can’t open it. Investors care because these compounds can form the basis of new medicines whose ability to block harmful signals affects clinical results, regulatory approval, market size, and future revenue potential.
pharmacologic profile medical
"a receptor antagonist with a well-established pharmacologic profile"
A pharmacologic profile summarizes how a drug behaves in the body — what it targets, the intended benefits, how quickly and for how long it acts, common side effects, and how it is absorbed, broken down and eliminated. For investors, this profile is like a product spec sheet: it helps judge a drug’s likely effectiveness, safety risks, dosing convenience and regulatory hurdles, all of which drive market potential, development costs and approval chances.
oncodermatology medical
"within the rapidly expanding oncology supportive-care and oncodermatology markets"
Oncodermatology is the medical specialty that focuses on skin conditions caused by cancer itself and by cancer treatments, including diagnosis, management and prevention of rashes, sores, and skin cancers. For investors, it matters because advances in drugs, diagnostics or supportive therapies for these skin problems can create new markets or affect adoption of oncology treatments—think of it as the field that keeps a high-performance car’s paint and body intact while the engine (cancer treatment) is being upgraded.

AI-generated analysis. Not financial advice.

NEW YORK, Jan. 2, 2026 /PRNewswire/ -- Hoth Therapeutics (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing innovative therapies for underserved medical needs, today announced the filing of two U.S. provisional patent applications that significantly expand the Company's intellectual property portfolio and establish a new oncology-focused dermatology platform targeting treatment-induced skin toxicity from modern cancer therapies.

The first provisional patent application, titled covering the topical treatment of radiation-induced skin toxicity in oncology patients.

The second provisional patent application, titled addressing dermatologic toxicities associated with emerging targeted cancer therapies, including second and third menin inhibitors.

Together, these dual filings secure priority intellectual property rights around the use of HT-001 to treat dermatologic toxicities across multiple oncology treatment modalities, including radiation therapy and next-generation targeted agents. As cancer treatments become more effective and patients remain on therapy longer, managing treatment-limiting skin toxicities has become a critical and growing unmet need in oncology care.

Radiotherapy-induced dermatitis and dermatologic adverse effects from targeted oncology therapies frequently result in pain, inflammation, severe pruritus, infection risk, reduced quality of life, and treatment interruption or discontinuation, which can negatively impact patient outcomes. Despite their prevalence, current treatment options remain largely supportive, with few mechanism-driven therapies designed to address the underlying biological drivers of these conditions.

Hoth's patent filings seek to protect the use of HT-001, a receptor antagonist with a well-established pharmacologic profile, to target neurogenic and inflammatory pathways implicated in therapy-induced skin injury. The Company believes this approach may represent a novel and potentially first-in-class strategy within the rapidly expanding oncology supportive-care and oncodermatology markets.

"These filings represent a meaningful expansion of our intellectual property estate into an increasingly important area of oncology care," said Robb Knie of Hoth Therapeutics. "As cancer therapies advance, the ability to manage treatment-related toxicities is becoming essential. We believe this emerging platform highlights our strategy of identifying differentiated, mechanism-driven opportunities that can address significant unmet needs while creating long-term shareholder value."

The Company believes these provisional patents support the development of a scalable oncology-adjacent platform with potential applications across radiation oncology, targeted cancer therapies, dermatology, and inflammatory skin disorders, while leveraging an established compound in novel therapeutic contexts, formulations, and routes of administration. The filings also provide flexibility to pursue additional preclinical development, formulation optimization, and future U.S. and international patent protection.

Hoth Therapeutics continues to execute its strategy of building a diversified, IP-centric development portfolio focused on large, underserved markets, with an emphasis on therapies designed to improve patient outcomes and quality of life.

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

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/hoth-therapeutics-expands-oncology-pipeline-with-dual-patent-filings-establishing-novel-oncology-dermatology-ip-platform-302651580.html

SOURCE Hoth Therapeutics, Inc.

FAQ

What did Hoth Therapeutics (HOTH) announce on January 2, 2026?

Hoth filed two U.S. provisional patent applications to protect use of HT-001 for radiation-induced and targeted-therapy dermatologic toxicities.

What does a U.S. provisional patent filing mean for HOTH investors?

A provisional filing secures priority date and flexibility to pursue later nonprovisional patents but is not a granted patent and requires further filings.

How does HT-001 aim to treat treatment-induced skin toxicity according to HOTH?

The company describes HT-001 as a receptor antagonist targeting neurogenic and inflammatory pathways linked to therapy-induced skin injury.

Which oncology therapies are covered by HOTH's new provisional filings for HOTH?

The filings target radiation therapy skin toxicity and dermatologic adverse effects from emerging targeted agents, including later-generation menin inhibitors.

Do the filings mean HT-001 is ready for clinical use in oncology dermatology?

No; the filings support development, but Hoth notes additional preclinical and formulation work is planned before regulatory steps.
Hoth Therapeutics Inc

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Biotechnology
Pharmaceutical Preparations
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