Hoth Therapeutics, Inc. (HOTH): Business Model Canvas [Dec-2025 Updated]

You're looking at Hoth Therapeutics, Inc. (HOTH) and seeing the textbook profile of a clinical-stage player: all focus on the science, zero revenue reported for Q3 2025, but with a pipeline that's definitely advancing. Honestly, my two decades in this game tell me the real story is the cash management; they burned through operating expenses totaling $4.08 million in Q3, funded by raising $8.76 million year-to-date 2025, leaving them with $7.85 million in the bank as of September 30, 2025. To see exactly how this cash burn supports their value proposition-from the topical rash treatment HT-001 to the Alzheimer's candidate HT-ALZ-you need to map out the whole engine, so check out the full Business Model Canvas below.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Key Partnerships

You're looking at the structure that supports Hoth Therapeutics, Inc.'s pipeline advancement, especially as the company operates in a pre-revenue, clinical-stage environment. The key is how they structure these external relationships to manage capital and technical execution. Here's the breakdown of their critical alliances as of late 2025.

Atlanta VA Medical Center for the GDNF Metabolic Program

Hoth Therapeutics, Inc. has a significant research partnership with the U.S. Department of Veterans Affairs (VA) and the Foundation for Atlanta Veterans Education and Research (FAVER) via a Cooperative Research and Development Agreement (CRADA). This program evaluates glial cell line-derived neurotrophic factor (GDNF) as a potential first-in-class biologic for obesity and nonalcoholic fatty liver disease (NAFLD). Hoth Therapeutics will fund this study and supply the GDNF compound, while the VA retains data rights and shares de-identified results. This landmark agreement sets up a direct comparison of daily GDNF injections against semaglutide, the current standard in this area.

The timeline for this collaboration is tightly scheduled:

Contract Research Organizations (CROs) for Clinical Trial Execution

For clinical execution, Hoth Therapeutics, Inc. relies on external expertise, which is standard for a company advancing multiple assets like its HT-001 Phase 2 trial and HT-KIT IND-enabling activities. The reliance on CROs allows Hoth Therapeutics to manage its capital structure efficiently; for instance, emerging biopharma companies were responsible for 63% of overall clinical trial starts in 2025. This outsourcing model helps manage the complexity of global trials, as Hoth Therapeutics has submitted a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for its HT-001 trial, with European enrollment anticipated in early 2026.

While specific CRO partners aren't named in the latest updates, the industry context shows significant scale:

• The global CRO market was estimated at up to $82 billion in 2024.
• This market is projected to reach USD 139.42 billion by 2029.
• Hoth Therapeutics is progressing its HT-KIT program toward an expected IND submission in 2026.

Third-party Manufacturers for Clinical Supply Production

Manufacturing partnerships are crucial for scaling up drug substance for clinical use. Hoth Therapeutics, Inc. is actively engaged in manufacturing scale-up for its HT-KIT program, which has received FDA Orphan Drug Designation. This effort is part of the IND-enabling activities that are expected to conclude with an IND submission in 2026. The company's updates specifically note that ongoing manufacturing scale-up and analytical characterization are key accomplishments for HT-KIT. The focus here is on ensuring the formulation, methods, and manufacturing processes meet the standards required for regulatory filing.

Academic Institutions and Research Collaborators for Early-Stage Discovery

Hoth Therapeutics, Inc. leverages academic partnerships to drive early-stage research and validation, which helps diversify its intellectual property portfolio. A key example involves the HT-ALZ program for Alzheimer's disease. The company is collaborating with Washington University School of Medicine in St. Louis on a recently submitted NIH grant proposal focused on using an NK-1 receptor antagonist to reduce neuroinflammation. Furthermore, the company explicitly states it maintains collaborations with leading institutions, including the Atlanta VA Medical Center and academic neuroscience groups, to seek out and investigate therapeutics with immense potential.

The company's strategy involves expanding IP protection around these collaborations, including:

• HT-001 dermatology and oncology-supportive-care mechanisms.
• HT-KIT mast-cell-disease formulations, methods, and manufacturing.
• HT-ALZ CNS-focused data and delivery systems.

Finance: draft 13-week cash view by Friday.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Key Activities

You're looking at the core engine driving Hoth Therapeutics, Inc. (HOTH) right now-the specific, high-stakes actions management is taking to move their pipeline forward and keep the lights on. For a clinical-stage biotech, Key Activities are all about execution in the lab and the clinic, plus the necessary financial maneuvers to fund it all. Honestly, the focus is razor-thin on hitting those upcoming data readouts.

The most immediate activity involves the ongoing Phase 2 CLEER-001 clinical trial for HT-001, their topical treatment for rash associated with EGFR-inhibitors in cancer patients. The trial is advancing, and the safety profile has been favorable, showing no dose-limiting toxicities to date. You saw interim data from the Phase 2a portion where patients achieved a 50 percent reduction in pruritus severity over 21 days, with mean scores dropping from 1.6 on Day 1 to 0.8 by Day 21. Enrollment is continuing, and a further clinical update is anticipated in the coming months.

Simultaneously, Hoth Therapeutics is heavily engaged in the preclinical work for two other key assets. For HT-KIT, targeting mast cell diseases, the activity centers on completing the IND-enabling studies. This program already has FDA Orphan Drug Designation, and the company expects to finalize its Investigational New Drug (IND) submission in 2026. For the Alzheimer's therapeutic, HT-ALZ, the key activity is advancing through Good Laboratory Practice (GLP) and pharmacokinetic (PK) studies, which have shown positive results for pharmacokinetics and CNS-penetration modeling, with a regulatory-facing package also expected to mature in 2026.

Here's a quick look at where the pipeline stands as a result of these activities:

Defending and expanding the global Intellectual Property (IP) portfolio is a constant, necessary activity to protect future value. Hoth Therapeutics detailed this effort in early December 2025, noting they are continuing to strengthen the IP around all their programs. Specifically, the company reported new patent filings for both HT-001 and HT-KIT back on April 2, 2025. It's a defensive posture that underpins the entire R&D investment.

Finally, the financial activity of capital raising is critical, even when the company states it has no immediate plans for dilutive offerings. As of January 8, 2025, Hoth Therapeutics confirmed a strong financial position with over $10 million in cash and no debt. To maintain flexibility, the company did expand its existing At The Market (ATM) offering by $5 million in February 2025. This is layered on top of approximately $2.7 million worth of shares already sold under that agreement since late 2024. The company's market capitalization was reported at $18.64 million as of early December 2025, and they maintain a strong liquidity position, evidenced by a current ratio of 8.81.

These capital activities support the operational focus, which you can see summarized by the current pipeline status:

• Executing Phase 2 CLEER-001 trial for HT-001; saw 50 percent pruritus reduction in interim data.
• Advancing HT-KIT through IND-enabling studies; IND filing targeted for 2026.
• Conducting GLP/PK studies for HT-ALZ; regulatory package due in 2026.
• Strengthening IP portfolio, including new patent filings in April 2025.
• Managing capital via ATM program, which was expanded by $5 million in February 2025.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Key Resources

You're looking at the core assets Hoth Therapeutics, Inc. (HOTH) is banking on to drive future value. For a clinical-stage biopharma, these resources are everything-the cash to fund the science, the science itself, and the legal protection around it.

The most immediate tangible resource is the balance sheet strength, even in a pre-revenue setting. As of the reporting date near the end of 2025, Hoth Therapeutics, Inc. held Cash and equivalents of $7.85 million as of September 30, 2025. This cash position is supported by a very low leverage profile, with Total Debt reported at only $13,599, resulting in a Net Cash position of $7.83 million. The company also boasts a strong liquidity measure, with a Current Ratio of 8.81. Still, you have to note the burn rate; Operating Cash Flow was -$9.68M for the period.

The primary, high-value resources are the therapeutic pipeline assets. These are the potential future revenue drivers, each at a different stage of development:

• - Cash and equivalents of $7.85 million as of September 30, 2025.
• - Therapeutic pipeline assets, which include HT-001 (Phase 2), HT-KIT (IND-enabling), HT-ALZ (GLP studies), and the new GDNF program.
• - FDA Orphan Drug Designation secured for the HT-KIT program targeting mast cell diseases.
• - Core scientific team and experienced management, including CEO Robb Knie, supported by collaborations with institutions like the Atlanta VA Medical Center and Washington University.
• - Intellectual property (IP) and patent licenses, including an exclusive license from the U.S. Department of Veterans Affairs (VA) for the GDNF technology.

Here's a quick look at where the pipeline stands as of late 2025:

The intellectual property portfolio is actively being broadened around these assets. For instance, the HT-KIT platform has protection extending through 2039 via Japan Patent No. 7677628. Also, the company secured an exclusive license for the GDNF technology, which is protected under a patent portfolio jointly developed by the VA and Emory University. Hoth Therapeutics, Inc. is also using advanced computing resources, having secured annual NVIDIA AI Enterprise Essentials licenses to support development processes.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Value Propositions

You're looking at the core value Hoth Therapeutics, Inc. (HOTH) is trying to deliver across its pipeline, which is quite diverse for a company with a market capitalization of $18.64 million as of December 2025. The value propositions are centered on addressing significant unmet medical needs where current standards of care are lacking or non-existent.

Topical treatment (HT-001) to manage debilitating EGFR-inhibitor rash.

HT-001 offers a first-in-class topical therapy for skin toxicities caused by epidermal growth factor receptor (EGFR) inhibitors, which affect 90% of patients on these life-saving cancer drugs. The value here is in maintaining oncology treatment continuity.

• Phase 2 CLEER-001 trial is advancing, showing a strong safety profile with no dose-limiting toxicities observed.
• Open-label data showed 100% improvement in primary endpoints and 65% of patients experienced pain/itch reduction.
• The EU supportive care market for these conditions was valued at $4.04 billion in 2023.
• The overall oncology supportive care market is projected to reach $32.12 billion by 2033.

Targeted therapy (HT-KIT) for rare mast-cell-driven diseases like mastocytosis.

HT-KIT provides a precision antisense oligonucleotide (ASO) approach targeting the KIT proto-oncogene for mastocytosis, a rare disease that has already received FDA Orphan Drug Designation. This offers a mechanism to induce apoptosis in neoplastic mast cells.

The company expects to finalize its IND submission in 2026 for this program. The systemic mastocytosis market shows a growth rate of 5.8% CAGR through 2031.

Potential CNS-penetrating therapeutic (HT-ALZ) for Alzheimer's disease.

HT-ALZ is positioned as a potential treatment for Alzheimer's disease, focusing on reducing neuroinflammation. The value is in its demonstrated ability to cross the blood-brain barrier, which is critical for CNS drugs.

• Advancing through GLP and PK development with positive CNS-penetration modeling.
• Preclinical data showed acute treatment led to a rapid (~15%) reduction in brain interstitial fluid Aβ levels within 20 hours.
• A regulatory-facing package is expected in 2026.
• The target Alzheimer's market is projected to reach $5.2 billion by 2027.

Novel GDNF-based approach for obesity and metabolic dysfunction.

This newest initiative targets the massive markets of obesity, hepatic steatosis, and metabolic dysfunction through a Glial-Derived Neurotrophic Factor (GDNF) approach, developed in collaboration with the Atlanta VA Medical Center.

• Early data from this research program is anticipated in 2026.
• The obesity market size is expected to grow to $60.53 billion by 2030.

The company is defintely aiming at high-value, high-need areas.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Customer Relationships

You're looking at how Hoth Therapeutics, Inc. manages its critical external relationships as of late 2025. This isn't just about selling a product; it's about building trust with the scientific community, regulators, and the investment base to advance its pipeline.

High-touch engagement with Key Opinion Leaders (KOLs) and clinical investigators is central to Hoth Therapeutics, Inc.'s strategy, especially given its clinical-stage focus. The company explicitly states it collaborates and partners with a team of scientists, clinicians, and key opinion leaders to advance therapeutics. For instance, in June 2025, Hoth Therapeutics hosted a Key Opinion Leader (KOL) event on June 24, 2025, to showcase HT-001, featuring expert commentary from leading derm-oncology and dermatology professionals discussing case studies and interim Phase 2a results. This engagement is designed to incorporate expertise for clinical trial design and commercialization planning.

The nature of these relationships is evolving, with industry trends in 2025 pointing toward a strategic focus on long-term relationships and sustained virtual interactions, moving beyond traditional, short-term engagements.

Hoth Therapeutics, Inc. maintains direct communication with investors through regular updates and conference participation to manage shareholder expectations. The CEO, Robb Knie, was scheduled to present at the Noble Capital Markets 21st Annual Emerging Growth Equity Conference on December 2-3, 2025. Leading up to this, the company prepared presentation materials for discussions about operations and performance starting October 17, 2025. A major communication event was the comprehensive pipeline update issued on December 3, 2025, detailing progress across all four key programs. As of the October 14, 2025, snapshot, the company reported 15.4 million shares outstanding in investor-facing materials.

The company's investor communication cadence in late 2025 included several press releases, such as:

• Announcing acceptance into the NVIDIA Connect Program.
• Reporting the FDA Orphan Drug Designation for HT-KIT on October 21, 2025.
• Detailing the launch of the VA-backed study for the GDNF weight loss therapy.

Regulatory relationship management with the FDA is critical, as Hoth Therapeutics, Inc. is advancing assets through clinical and pre-clinical stages. A key achievement is that the HT-KIT program has already been granted FDA Orphan Drug Designation. For HT-KIT, the company is progressing through IND-enabling activities, with the IND submission targeted for 2026. For HT-ALZ, a regulatory-facing package is expected to mature in 2026. Furthermore, Hoth Therapeutics is managing international regulatory relationships, having submitted its Clinical Trial Application (CTA) to the European Medicines Agency (EMA) on September 10, 2025, with European patient recruitment for the HT-001 Phase II trial anticipated in early 2026. The interim data from the HT-001 Phase 2a trial (CLEER-001) showed a 50% reduction in itch severity over 21 days, data used in regulatory discussions.

Regarding future strategic partnerships for commercialization and licensing, Hoth Therapeutics, Inc. is actively building collaborations. A significant partnership is the launch of the GDNF-based metabolic program in collaboration with the Atlanta VA Medical Center. Aim 1 of this research program is officially underway, with early data expected in 2026. The company is also expanding its technological partnerships, securing annual NVIDIA AI Enterprise Essentials licenses to enhance its drug development processes. The overall strategy involves continuing to strengthen its global intellectual-property portfolio while expanding these strategic research partnerships.

Finance: draft 13-week cash view by Friday.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Channels

You're looking at how Hoth Therapeutics, Inc. (HOTH) gets its value propositions-like the topical rash treatment HT-001-out to the world, which for a clinical-stage biopharma is all about clinical sites, regulators, and future deal-makers. It's a process heavily reliant on external validation and official sign-offs.

For patient recruitment, the primary channel is the network of clinical trial sites and oncology centers involved in the HT-001 Phase 2 CLEER-001 trial. As of late 2025, enrollment is active in the U.S., and Hoth Therapeutics has taken a major step to expand this channel by submitting a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) in September 2025. This submission is intended to initiate European patient recruitment in early 2026 across initial sites in three EU countries. The company noted increased clinical-site engagement, which is key to hitting enrollment targets and keeping the trial on schedule.

The regulatory bodies are the gatekeepers, so submissions to the U.S. Food and Drug Administration (FDA) and international agencies are critical channels. Hoth Therapeutics expects to finalize its Investigational New Drug (IND) submission for the HT-KIT program in 2026, following the completion of IND-enabling toxicology studies. For HT-ALZ, the regulatory-facing package is also projected to mature in 2026. Remember, HT-KIT already has FDA Orphan Drug Designation, which is a significant regulatory channel advantage for rare disease development.

Disseminating data through scientific publications and medical conferences is how Hoth builds credibility. For instance, interim data from the HT-001 open-label trial, announced in April 2025, showed a 50% reduction in pruritus severity, with mean scores dropping from 1.6 on Day 1 to 0.8 by Day 21. Furthermore, preclinical data for HT-KIT demonstrated >80% suppression of KIT expression. The company actively used conferences as a channel, presenting pipeline updates at the Noble Capital Markets 21st Emerging Growth Equity Conference on December 2-3, 2025. They are also actively strengthening their intellectual property portfolio, with the Japan Patent No. 7677628 extending platform protection for HT-KIT to 2039.

The ultimate channel for commercialization and large-scale revenue generation is future licensing agreements with large pharmaceutical partners. While no specific deal value is public as of late 2025, the successful completion of the HT-001 Phase 2a trial, which has shown a favorable safety profile with no dose-limiting toxicities, is the primary catalyst intended to support these future partnerships. The company's market capitalization as of December 3, 2025, was $18.64 million, and analysts have an average target price of $4.50, implying a potential upside of 278.15% from the recent price of $1.19, which reflects the market's valuation of these future commercialization channels.

Here's a quick look at the key milestones that feed into these channels:

The company's current ratio of 8.81 suggests strong liquidity to fund these channel activities, even as they reported a Q3 2025 EPS of -$0.30, missing the consensus estimate of -$0.14. The earnings forecast suggests a move from ($1.36) to ($0.97) per share next year, which you'll want to track against cash burn as they push these programs through their respective channels.

Finance: draft 13-week cash view by Friday.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Customer Segments

You're looking at the core groups Hoth Therapeutics, Inc. (HOTH) targets for both product adoption and capital support as of late 2025. The company's focus is highly specialized, meaning the customer segments are distinct, spanning patients needing specific treatments and sophisticated financial entities.

Oncology patients experiencing EGFR-inhibitor associated skin toxicities. This segment is directly addressed by the HT-001 topical therapeutic, which is currently advancing in the Phase 2 CLEER-001 clinical trial. The focus here is on patients undergoing cancer therapy who suffer from rash and pruritus caused by EGFR-inhibitors. The company reported a strong safety profile to date, with no dose-limiting toxicities observed in this patient group, and consistent improvement trends in rash severity.

Patients with rare mast-cell diseases, including mastocytosis. The HT-KIT program is designed for this niche. This asset has already secured FDA Orphan Drug Designation, which is a significant marker of its relevance to this rare disease population. Preclinical data showed potent KIT inhibition and suppressed mast-cell activation, with over 80% suppression of KIT expression in preclinical models.

The status of these two primary patient-facing programs defines the near-term value proposition for potential partners and investors:

Institutional investors and biotech-focused funds. This group provides the necessary capital for clinical development. As of late 2025, the ownership structure shows that approximately 7.08% of Hoth Therapeutics stock is held by institutional investors. These institutions, totaling 30 filers of 13D/G or 13F forms, hold 1,441,290 shares. The stock price as of November 21, 2025, was $1.08 / share, against a market capitalization of $18.35 million. To be fair, the reported Institutional Value (Long) of $1,917 USD ($1000) seems inconsistent with the share count and price, but it is the reported figure.

Key financial metrics relevant to investor confidence include:

• Shares Outstanding (as of March 28, 2025): 13,170,715.
• Shares Change (YoY): Increased by +108.05%.
• Cash Position (as of Jan 2025): Over $10 million in cash.
• Debt Level: $0.0 total debt, resulting in a Debt / Equity ratio of 0.00.
• Current Ratio (2025): 8.81.
• Retail Investor Ownership: Approximately 93.63%.

Large pharmaceutical companies seeking late-stage pipeline assets. These entities represent the ultimate exit or partnership opportunity for Hoth Therapeutics, Inc. (HOTH). The attractiveness to this segment is driven by de-risked assets. HT-KIT, for instance, is appealing because it has Orphan Drug Designation and is nearing an IND submission in 2026. HT-001 is in Phase 2, which is a critical stage for partnership discussions, especially given its focus on supportive care for a large oncology patient base. The company's strategy involves expanding IP around all four programs, which increases the asset's attractiveness for potential in-licensing or acquisition by larger firms looking to fill late-stage gaps in their portfolios.

Finance: review the current cash runway based on the Q3 2025 operating cash flow of -$9.68M against the latest cash balance by end of next week.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Cost Structure

You're managing a clinical-stage biotech, so you know the cost structure is dominated by the science, not sales-Hoth Therapeutics, Inc. is no different. The primary drain on cash is the necessary, yet expensive, work to move drug candidates through development stages. Since Hoth Therapeutics, Inc. is pre-revenue, every dollar spent is an investment in future potential.

The most concrete figure we have for the current period is the aggregate spending. Operating expenses totaled $4.08 million for Q3 2025. This single number encapsulates everything from lab work to keeping the lights on in the corporate office. Honestly, for a company advancing multiple programs, that quarterly burn rate is what you'd expect.

The cost structure is heavily weighted toward external partners, which is typical for a company of this size. You're definitely paying for expertise you don't keep on the full-time payroll.

• - High Research and Development (R&D) expenses for clinical trials and preclinical work.
• - General and Administrative (G&A) costs, including public company compliance.
• - Operating expenses totaled $4.08 million for Q3 2025.
• - Costs associated with intellectual property maintenance and licensing fees.

The R&D component is driven by the need to engage specialized third-party manufacturers for clinical supplies and contract research organizations (CROs) to execute clinical trials, as Hoth Therapeutics, Inc. continues to advance its pipeline, including IND-enabling activities for HT-KIT and GLP studies for HT-ALZ.

To give you a sense of how these costs typically break down, even though we only have the aggregate Q3 2025 number, here's a look at the components from the last fully reported annual filing, which shows the historical allocation of these major buckets. This helps you see where the money has historically gone:

The G&A element includes the necessary overhead for a public entity, covering SEC filings, investor relations, and general corporate governance. Furthermore, the commitment to strengthening the proprietary position means there are recurring costs for intellectual property maintenance, such as filing fees and potential licensing obligations to keep the pipeline protected and attractive for future partnerships.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Hoth Therapeutics, Inc. (HOTH) as of late 2025. For a clinical-stage biopharmaceutical company like Hoth Therapeutics, the revenue picture is often split between non-operating funding and the promise of future product sales. Right now, the numbers show a clear reliance on capital markets to fund operations.

The reported revenue for the third quarter of 2025 was $0.00. Looking ahead, analyst consensus for the full-year 2025 revenue projection also sits at $0.

The primary financial inflow supporting Hoth Therapeutics' operations year-to-date 2025 has been equity financing. As of the Q3 2025 filing, the company had received $8.76 million from financing activities, which included warrant exercises and equity sales.

To be fair, this financing is crucial for runway. Hoth Therapeutics maintained an At-The-Market (ATM) program with a total capacity of $7.7 million; approximately $5.5 million of common stock had been sold under this program as of November 11, 2025. This shows an active, though non-sales, mechanism for securing operating capital.

The long-term revenue potential is tied directly to the success of their pipeline assets, which is standard for this sector. This potential is structured around agreements already in place.

Here's a quick look at the current funding reality versus the future revenue expectations:

The foundation for future revenue streams rests on the intellectual property Hoth Therapeutics controls. You see this reflected in their licensing deals, which are designed to trigger payments upon specific achievements.

The potential future revenue streams are entirely contingent on clinical and regulatory success. These streams include:

• - Potential future milestone payments from licensing agreements.
• - Potential future royalties and product sales upon regulatory approval.

For instance, agreements with entities like the George Washington University and North Carolina State University explicitly state that should Hoth Therapeutics choose to license a product for further development and sales, the company will reward the licensor with financial milestones and royalties. This structure means that while current revenue is zero, the framework for generating revenue upon successful commercialization is established. Finance: draft 13-week cash view by Friday.