Hoth Therapeutics, Inc. (HOTH): History, Ownership, Mission, How It Works & Makes Money

Hoth Therapeutics, Inc. (HOTH): History, Ownership, Mission, How It Works & Makes Money

US | Healthcare | Biotechnology | NASDAQ

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As a seasoned investor, you've defintely seen the volatility in micro-cap biotech, but what makes Hoth Therapeutics, Inc. (HOTH), with its $17 million market capitalization, a name you need to watch right now?

Despite reporting a recent Q3 2025 earnings per share (EPS) of -$0.30, this clinical-stage biopharmaceutical company is advancing a diverse pipeline, including HT-001, which showed 100% success in treating cancer-related skin toxicities in its Phase 2a interim results, a major de-risking event.

Their strategy is a blend of traditional drug development-like the HT-KIT precision oncology program-and modern financial moves, like expanding their treasury reserve to include up to $1 million in digital assets, so you have to understand how they plan to bridge the gap from R&D expense to commercial revenue.

Hoth Therapeutics, Inc. (HOTH) History

You're looking for the foundational story of Hoth Therapeutics, Inc., a clinical-stage biopharmaceutical company, and how it evolved from a startup idea into a NASDAQ-listed entity. The direct takeaway is that Hoth Therapeutics was established in 2017 by founder Robb Knie with an initial focus on topical treatments for skin disorders, quickly securing an early-stage funding of $675,000 to begin developing its proprietary drug platform.

Given Company's Founding Timeline

Year established

Hoth Therapeutics, Inc. was founded in 2017.

Original location

The company is headquartered in New York, New York.

Founding team members

The company was founded by Robb Knie, who has served as the President and Chief Executive Officer since May 2017.

Initial capital/funding

Hoth Therapeutics' first funding round was a Seed round on July 12, 2017, raising $675,000. This was followed by a Series A financing in February 2018 that totaled $3 million to advance the BioLexa Platform, its proprietary drug compound platform.

Given Company's Evolution Milestones

Year Key Event Significance
2017 Founding and initial Seed funding of $675K. Established the company and secured initial capital to start development of the BioLexa Platform.
2018 Completed $3 million Series A financing. Funded operations and accelerated the development of the BioLexa Platform, primarily targeting atopic dermatitis (eczema).
2019 Post-IPO financing round raising $2.04 million. Continued capital raising to support the transition to a clinical-stage company and advance its pipeline.
June 2025 Regained compliance with Nasdaq minimum bid price requirement. Averted a delisting threat, stabilizing the stock and allowing the company to focus fully on its clinical pipeline.
October 2025 HT-KIT granted FDA Orphan Drug Designation. Accelerated regulatory pathway and potential market exclusivity for HT-KIT in rare c-KIT-driven cancers.
November 2025 Accepted into the NVIDIA Connect Program. Gained access to advanced AI platforms to enhance drug-development programs and improve modeling efficiency.

Given Company's Transformative Moments

The company's trajectory shows a clear shift from a single-platform focus to a diversified, multi-asset pipeline, which is a common, defintely high-risk, high-reward biotech strategy. This diversification, especially into oncology and metabolic disease, is the biggest change since its founding.

  • Pipeline Expansion: The initial focus on the BioLexa Platform for eczema (HT-001) broadened significantly through licensing and research agreements. This led to a portfolio including HT-KIT for mast-cell derived cancers and HT-ALZ for neuroinflammatory diseases. This move spreads risk, but also demands more capital.
  • Strategic Partnerships and AI Integration: In 2025, Hoth Therapeutics made a pivotal decision to integrate Artificial Intelligence (AI) into its research and development, selecting the NVIDIA AI Enterprise Platform and joining the NVIDIA Connect Program. This is a forward-looking move to increase the speed and efficiency of drug discovery, a necessary step to compete with larger biopharma firms.
  • Financial Resilience in 2025: Despite incurring a net loss of $8.2 million for the fiscal year ending in 2024 (reported in the March 2025 10-K), the company affirmed a strong balance sheet in January 2025 with over $10 million in cash and no debt. This cash position, coupled with regaining Nasdaq compliance in June 2025, provided the financial stability needed to advance its Phase 2 clinical trials.
  • Entry into Metabolic Disease: A major strategic pivot in 2025 was the launch of a VA-Backed Study of a novel GDNF weight loss therapy, targeting the high-value obesity and fatty liver disease markets. This immediately positioned the company in a multi-billion dollar therapeutic area.

You can get more context on the current investment landscape for the company in Exploring Hoth Therapeutics, Inc. (HOTH) Investor Profile: Who's Buying and Why?

Hoth Therapeutics, Inc. (HOTH) Ownership Structure

Hoth Therapeutics, Inc. (HOTH) is a publicly traded, clinical-stage biopharmaceutical company, and its ownership structure is heavily weighted toward individual retail investors, which is not uncommon for a smaller, early-stage biotech firm.

Given Company's Current Status

As of November 2025, Hoth Therapeutics is a public entity, trading on the Nasdaq Capital Market (Nasdaq: HOTH). The company is categorized as a smaller reporting company and a non-accelerated filer, reflecting its market capitalization and revenue profile.

The company's stock was recently trading at $1.18 per share on November 18, 2025, with a total of approximately 15,514,312 shares of common stock outstanding as of November 11, 2025. This public status means the company is subject to U.S. Securities and Exchange Commission (SEC) reporting requirements, providing transparency into its financials and governance.

Given Company's Ownership Breakdown

The company's capital structure is dominated by retail investors, which translates to higher stock price volatility and a greater influence from market sentiment over large institutional block trades. This is a key factor to consider when Exploring Hoth Therapeutics, Inc. (HOTH) Investor Profile: Who's Buying and Why?

Shareholder Type Ownership, % Notes
Retail/Individual Investors 88.79% Calculated as the remaining float; a high percentage for a public company.
Institutional Investors 7.08% Includes funds like Virtu Financial LLC and Geode Capital Management LLC.
Insider/Executive Ownership 4.13% Primarily held by the CEO, Robb Knie.

Here's the quick math: Institutional investors hold a modest 7.08%, and insiders, including the CEO, own 4.13%. That leaves a substantial 88.79% of the company's stock in the hands of the public, which defintely amplifies the importance of retail sentiment.

Given Company's Leadership

The company is steered by a management team with an average tenure of 6.6 years, providing a measure of stability in the volatile biotech sector. The leadership is focused on advancing its clinical pipeline, which includes HT-001 for cancer-therapy-induced rash and HT-KIT for precision oncology.

  • Robb Knie: Founder, President, and Chief Executive Officer (CEO). He has served in this role since May 2017 and is also the Chairman of the Board. His total compensation for the 2024 fiscal year was approximately $1.23 million.
  • David S. Briones: Chief Financial Officer (CFO) and Principal Accounting Officer.
  • Hayley Springer: Executive Vice President of Operations.

The Board of Directors also includes Independent Directors like David Sarnoff, Wayne Linsley, and Jeff Pavell, D.O., who provide oversight and legal/medical expertise, with the average tenure for the board being 5.5 years. This mix of long-tenured executives and experienced independent directors is crucial for navigating the complex regulatory environment of clinical-stage drug development.

Hoth Therapeutics, Inc. (HOTH) Mission and Values

Hoth Therapeutics' core purpose is to be a catalyst in early-stage pharmaceutical research, focused intently on developing innovative treatments that directly address significant unmet medical needs and improve patient quality of life. This patient-centric mission is the cultural bedrock that guides their clinical-stage pipeline, even as they navigate the financial realities of pre-revenue biotechnology.

Hoth Therapeutics' Core Purpose

You're looking at a clinical-stage biopharmaceutical company, which means their value isn't in today's sales, but in tomorrow's potential breakthroughs. Their purpose is simple: to bring truly new, life-changing therapies from the lab bench to the patient. This is why their pipeline is diversified across high-impact areas like oncology, neurology, and inflammatory diseases, not just one bet.

For example, their lead drug, HT-001, is aimed at treating the debilitating skin toxicities caused by EGFR inhibitor cancer therapies. This isn't just a marginal improvement; for patients, it's about continuing critical, life-saving cancer treatment without having to stop due to severe side effects. That's the real-world impact of their core purpose. To be fair, this high-stakes R&D focus is why Hoth Therapeutics reported a net loss of $4.11 million for the third quarter of 2025, with no revenue-it's the cost of chasing those breakthroughs.

Official mission statement

The company's mission is a clear statement of intent, prioritizing the human element in drug development.

  • Strive to develop innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life.
  • Act as a catalyst in early-stage pharmaceutical research and development, elevating promising drugs from the bench to pre-clinical and clinical testing.
  • Bring value to both our patient populations and our shareholders by addressing unmet medical needs.

Vision statement

Hoth Therapeutics' vision is centered on broad access and compassionate care, which is a necessary perspective in a field where high drug costs are a constant public debate. They are working toward a common vision of improved patient care.

Their corporate philosophy is built around three core values: Innovation, Responsibility, and Integrity. You need all three to succeed in biotech; innovation gets you the drug, but responsibility and integrity are what get you through the regulatory gauntlet and build investor trust.

Here's the quick math on their runway: as of September 30, 2025, the company had $7.85 million in cash and cash equivalents, which management believes is enough to fund their current clinical and pre-clinical programs. That cash position is a defintely a reflection of their responsible management value. You can dive deeper into the shareholder structure and capital strategy in Exploring Hoth Therapeutics, Inc. (HOTH) Investor Profile: Who's Buying and Why?

Hoth Therapeutics slogan/tagline

The company's philosophy is captured in a simple, direct phrase that speaks to their commitment beyond a niche market.

  • Innovating for Everyone.

This tagline underscores their belief that all patients deserve the best quality of life possible, even while undergoing treatment, and it drives their focus on diversified therapeutic areas like HT-KIT for rare c-KIT-driven cancers and HT-VA for obesity and metabolic syndrome. With approximately 15,514,312 shares outstanding as of November 2025, every clinical milestone they hit or miss impacts a large base of investors who are buying into this mission.

Hoth Therapeutics, Inc. (HOTH) How It Works

Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on in-licensing and developing next-generation therapeutics for high-unmet-need conditions, primarily in supportive oncology and rare diseases. The company doesn't generate revenue yet-its trailing 12-month revenue as of June 30, 2025, was $0.00-instead, it operates by advancing promising drug candidates through preclinical and clinical trials to create value for a potential partnership or eventual commercialization.

Given Company's Product/Service Portfolio

Product/Service Target Market Key Features
HT-001 Topical Gel Skin toxicities from EGFR inhibitor cancer therapies and radiotherapy. Topical neurokinin 1 receptor agonist (NK1RA) formulation; Phase 2 interim data showed 100% patient improvement; utilizes the FDA's 505(b)(2) pathway for faster approval.
HT-KIT Injection Mast-cell derived cancers, including systemic mastocytosis and Gastrointestinal Stromal Tumors (GIST). Precision antisense oligonucleotide (ASO) targeting KIT mRNA; received FDA Orphan Drug Designation; preclinical data showed >80% suppression of KIT expression.
HT-ALZ Oral Film Alzheimer's Disease and other neuroinflammatory conditions. Oral film formulation of an NK-1 receptor antagonist; leverages AI-driven insights for blood-brain barrier (BBB) penetration; Phase 1 trial expected in 2025-2026.
BioLexa Topical Atopic Dermatitis (Eczema). Novel, affordable topical option positioned in the estimated $18 billion eczema market.

Given Company's Operational Framework

Hoth's operational strategy is built on a lean, outsourced research and development (R&D) model, which helps keep its operating expenses lower than many peers. Its Q3 2025 Earnings Per Share (EPS) was -$0.30, missing the analyst consensus, which shows the typical cash burn of a clinical-stage biotech.

  • In-Licensing and Formulation Focus: The company acquires exclusive worldwide licenses for late preclinical or early clinical assets from academic institutions and research organizations.
  • Specialized Delivery: A core focus is on formulation science, using topical and localized administration platforms to enhance drug penetration, sustain release, and reduce systemic exposure.
  • Regulatory Efficiency: For its lead asset, HT-001, Hoth is using the FDA's 505(b)(2) regulatory pathway. This allows the company to reference the FDA's findings of safety and efficacy for a previously approved drug, potentially accelerating the development timeline and reducing costs. It's a smart way to de-risk a program.
  • Expanded Access Program (EAP): Hoth launched an EAP for HT-001 in 2025, providing compassionate access to cancer patients with severe skin toxicities before full commercial approval. This generates critical real-world data and signals strong demand ahead of a potential launch.

Given Company's Strategic Advantages

You need to look past the current market capitalization of roughly $16 million to $18.96 million to see the real strategic value here; it's all in the pipeline and the technology.

  • First-in-Class Potential: HT-001 is positioned to be the first approved product specifically for skin toxicities from EGFR inhibitor cutaneous toxicities, which occur in up to 90% of patients. This addresses a major unmet need in oncology supportive care.
  • AI-Powered R&D: Hoth was accepted into the NVIDIA Connect Program in November 2025, giving them access to advanced computing and AI platforms. This partnership will defintely enhance computational-biology workflows, speed up modeling, and improve the efficiency of preclinical decision-making across the pipeline, including programs like HT-ALZ.
  • Orphan Drug Status: HT-KIT received FDA Orphan Drug Designation, which grants seven years of market exclusivity post-approval, along with tax credits and fee waivers. This significantly de-risks the program and positions Hoth to capture a fragmented systemic mastocytosis market projected to be worth $269.9 million.
  • Diversified Pipeline: The multi-asset approach across oncology (HT-001, HT-KIT), neurology (HT-ALZ), and dermatology (BioLexa) reduces reliance on a single program, offering multiple shots on goal. You can dive deeper into the potential upside here: Breaking Down Hoth Therapeutics, Inc. (HOTH) Financial Health: Key Insights for Investors.

Hoth Therapeutics, Inc. (HOTH) How It Makes Money

Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company, meaning it does not currently generate revenue from commercial product sales; its financial engine is entirely focused on research and development (R&D) and is funded through external financing activities like equity sales and warrant exercises. As of the third quarter of 2025, the company reported $0.00 in net revenues, which is typical for a company advancing a pipeline of novel therapies toward clinical milestones.

Hoth Therapeutics' Revenue Breakdown

The company's business model is structured to eventually generate revenue through two primary streams: licensing its intellectual property (IP) to larger pharmaceutical partners and, ultimately, commercial product sales after regulatory approval. Right now, both are at 0% of total revenue.

Revenue Stream % of Total Growth Trend
Licensing & Collaboration Fees 0% Increasing (Future Potential)
Product Sales (Post-Approval) 0% Increasing (Future Potential)
Other Income (Interest/Grants) <1% Stable/Nominal

Business Economics

The economics of a clinical-stage biotech like Hoth Therapeutics are defined by its cash burn rate (the speed at which it spends its capital) and its ability to secure new funding, not by gross margins. You are investing in a future cash flow stream, not a present one.

  • R&D Expense is the Core Cost: The company's primary expense is R&D, exemplified by the approximately $2.0 million spent in Q1 2025 alone, which includes significant investment in programs like HT-001 and HT-KIT.
  • Cash Runway and Financing: Hoth Therapeutics is sustained by capital raises. Year-to-date through Q3 2025, the company used $7.65 million in operating cash but received $8.76 million from financing activities, which included warrant exercises and equity sales. This is how the lights stay on.
  • Valuation Driver: The value of the company, with a market capitalization of roughly $17 million as of November 2025, is tied to the successful progression of its drug candidates (HT-001, HT-ALZ, etc.) through clinical trials, not current earnings.
  • Pricing Strategy (Future): If a therapy like HT-001 (for cancer-drug side effects) reaches the market, its pricing will likely be premium, reflecting the high unmet need in a niche market where no approved therapies currently exist.

Hoth Therapeutics' Financial Performance

For a pre-revenue company, financial performance is measured by cash management and the cost of advancing its pipeline, not profitability. The key metric is the net loss, which shows the cost of doing business.

  • Net Loss: The company reported a net loss of $4.11 million for the third quarter ended September 30, 2025. This loss is a direct reflection of R&D and general and administrative expenses.
  • Year-to-Date Loss: For the nine months ended September 30, 2025, the total net loss was $9.78 million. That's the cost of moving the science forward.
  • Cash Position: Liquidity is the single most important factor. As of September 30, 2025, Hoth Therapeutics had cash and cash equivalents of $7.85 million. Management believes this is enough to fund operations for at least the next 12 months, but they defintely note that additional capital will be needed to fully advance programs.
  • Per-Share Performance: The trailing twelve-month Earnings Per Share (EPS) as of Q3 2025 was -$1.06, indicating the per-share cost of the company's development activities.

For a deeper dive into the balance sheet and cash flow, you might want to read Breaking Down Hoth Therapeutics, Inc. (HOTH) Financial Health: Key Insights for Investors.

Hoth Therapeutics, Inc. (HOTH) Market Position & Future Outlook

Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company with a high-risk, high-reward profile, positioning itself as a first-mover in niche, high-unmet-need markets, notably for cancer therapy-related skin toxicities. The company's future outlook hinges entirely on the successful clinical and regulatory advancement of its pipeline, particularly the lead asset HT-001, which has generated promising Phase 2a data.

Competitive Landscape

Hoth Therapeutics operates in a highly competitive biopharma space, but its lead program, HT-001, targets a specific, multi-hundred-million-dollar niche-cancer therapy-related rashes-where there is currently no approved product on the market. This lack of a direct, approved competitor is Hoth's core competitive advantage, even though the company itself is pre-revenue. Here's the competitive landscape, using market capitalization as a proxy for current size among its small-cap peers:

Company Market Share, % Key Advantage
Hoth Therapeutics, Inc. 0% (Pre-Revenue) First-mover advantage with HT-001; 100% efficacy in Phase 2a for EGFR inhibitor-induced rash.
Lipocine N/A (Small-Cap Peer) Focus on men's and women's health with oral drug delivery technology.
Processa Pharmaceuticals N/A (Small-Cap Peer) Repurposing approved drugs to improve efficacy and safety in oncology and other diseases.

Opportunities & Challenges

The company's strategy is to in-license promising early-stage assets and leverage specialized delivery platforms, but this model faces the inherent capital intensity of drug development. The recent acceptance into the NVIDIA Connect Program in November 2025 is a strategic move to use Artificial Intelligence (AI) to accelerate its R&D, but execution risk remains high.

Opportunities Risks
Capture a significant share of the $4.8 billion global market for EGFR inhibitor-induced skin disorders by 2025 with HT-001. HT-001 faces regulatory hurdles in later-stage (Phase 3) clinical trials, which are costly and unpredictable.
Accelerate R&D timelines and reduce computational bottlenecks by integrating AI through the NVIDIA Connect Program (announced November 2025). The company has $0.00 in annual revenue and reported a net loss of approximately $2.2 million in Q2 2025, raising cash runway concerns.
Diversify revenue potential with a multi-asset pipeline, including HT-ALZ (Alzheimer's) and HT-KIT (Rare Mast Cell Cancers), with Phase 1 trials expected in 2025-2026. Significant shareholder dilution has occurred in the past year, which can erode investor confidence and value.

Industry Position

Hoth Therapeutics is a micro-cap, clinical-stage biopharmaceutical company with a market capitalization of around $16 million as of November 2025, placing it firmly in the high-risk, high-growth segment of the industry. The company is currently a non-accelerated filer and a smaller reporting company, reflecting its early stage and limited financial resources.

To be fair, the balance sheet shows financial prudence in one key area: the company holds a current ratio of 27.6, meaning its short-term assets significantly outweigh its short-term liabilities, a strong liquidity position for a development-stage company with a cash reserve of nearly $9 million. Still, a current ratio doesn't pay for Phase 3 trials.

  • Development-Stage Focus: The entire value proposition is tied to clinical success, not current sales.
  • Strategic IP: The company focuses on robust patent expansion, which is defintely a necessary defense against larger competitors.
  • Analyst Sentiment: As of November 2025, analysts have a consensus 'Hold' rating on the stock, with an average price target of $4.50, suggesting a potential upside of over 291% from the current price, but this is a forecast based on clinical success.

For a deeper dive into the company's foundational principles, you should review its Mission Statement, Vision, & Core Values of Hoth Therapeutics, Inc. (HOTH).

Next Step: Finance should model the cash runway sensitivity based on an estimated $10 million cost for a Phase 3 trial initiation by Q2 2026, assuming HT-001 progresses.

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