US Market News
1週前
Rocket One Reports Approximately $8.4 Million in Cash and Cash Equivalents and Outlines Strategy Across AI Infrastructure, Spintronic Computing for Space and Defense MarketsJune 15, 2026 8:11 AM
PR Newswire (US) HOBOKEN, N.J., June 15, 2026 /PRNewswire/ -- Rocket One, Inc. (Nasdaq: RKTO) ("Rocket One" or the "Company"), a company focused on advanced computing technologies and next-generation infrastructure for the space economy, today provided an update to its shareholders. Dear Fellow Shareholders,The past several months have marked a transformative period for our Company. Following our transition from Hoth Therapeutics to Rocket One Inc. (Nasdaq: RKTO), we have begun executing a strategy focused on advanced computing, artificial intelligence infrastructure, space systems, and defense-related technologies.We believe the coming decade will be defined by the convergence of artificial intelligence, space infrastructure, and national security modernization. Each of these markets requires increasingly powerful, efficient, and resilient computing architectures. Rocket One was created to pursue opportunities at this intersection.Today, Rocket One is building a foundation that includes exclusive licenses to technology, a growing network of technical and strategic advisors, and a long-term vision focused on next-generation computing technologies and their potential applications across commercial, space, and defense markets.Financial PositionAs of June 12, 2026, Rocket One had approximately $8.4 million in cash and cash equivalents. The Company's cash position reflects proceeds received through its previously disclosed at-the-market ("ATM") equity program. Additional information regarding shares issued and proceeds received under the ATM program is available in the Company's filings with the U.S. Securities and Exchange Commission at www.sec.gov.Building Rocket OneArtificial intelligence is rapidly becoming one of the largest infrastructure markets in the world. At the same time, the growth of satellite networks, edge computing, and national security technologies is creating demand for computing architectures that deliver greater performance while consuming less power.Rocket One believes that the same characteristics that make advanced computing technologies attractive for AI infrastructure—including lower power consumption, reduced memory movement, improved efficiency, and enhanced performance—may also prove valuable in future space and defense environments where power, thermal management, reliability, and operational efficiency are critical design constraints.Our objective is to position Rocket One at the convergence of these trends through a combination of acquiring rights to certain intellectual property, entering into strategic partnerships, developing technical expertise, and employing disciplined capital allocation and targeted growth initiatives.Exclusive Spintronic and Nanomagnetic Computing TechnologyOn May 15, 2026, Rocket One entered into two exclusive license agreements relating to spintronic and nanomagnetic computing technologies designed for artificial intelligence and data-center applications.The licensed intellectual property includes novel all-spin matrix multiplication and nanomagnetic computing architectures intended to address some of the most significant challenges facing modern artificial intelligence, including power consumption, memory bottlenecks, and computational efficiency.Unlike conventional silicon-based approaches, spintronic computing utilizes the magnetic properties of electrons to process and store information. The underlying technologies are designed to leverage nanomagnetic structures that may enable highly energy-efficient computing, reduced data movement, and new approaches to AI hardware acceleration.Rocket One believes these technologies represent a compelling opportunity within the rapidly growing AI infrastructure market that could provide a foundation for future advanced-computing applications. Published research associated with the licensed technology has demonstrated the potential for substantial improvements in computational efficiency and power consumption relative to conventional architectures.Management believes that the characteristics associated with spintronic and nanomagnetic computing—including potential improvements in power efficiency, data movement, and computational performance—may be relevant to future space and defense computing environments, where power, thermal management, reliability, and operational efficiency are critical considerations.The Company is evaluating development pathways, strategic partnerships, and commercialization opportunities designed to advance these technologies toward practical applications in artificial intelligence infrastructure, advanced computing, space systems, and defense-related technologies.Expanding Our Advisory NetworkRocket One continues to strengthen its leadership and advisory capabilities through the addition of distinguished experts across advanced computing, aerospace, military, and spaceflight disciplines.Dr. Supriyo Bandyopadhyay serves as Lead Technical Advisor for AI Nanomagnetic Technology and is a recognized professor and researcher who has worked in the areas of spintronic and nanomagnetic computing research.Major General Malcolm B. Frost (Ret.) recently joined Rocket One's Space and Defense Advisory Board. General Frost brings more than three decades of military leadership experience and strategic expertise across defense operations, national security, and emerging technologies.Colonel Robert "Shane" Kimbrough (Ret.) joined Rocket One's Space and Defense Advisory Board. Colonel Kimbrough is a former NASA astronaut and former Commander of the International Space Station who brings firsthand experience in human spaceflight, orbital operations, and the future of the space economy.Together, these advisors strengthen Rocket One's ability to evaluate opportunities across advanced computing, artificial intelligence, space infrastructure, and defense technologies.Legacy Biotechnology PortfolioWhile Rocket One has embarked on a new strategic direction, the Company continues to maintain ownership of the biotechnology assets developed under Hoth Therapeutics.This includes HT-001, the Company's clinical-stage program focused on the treatment of EGFR inhibitor-associated skin toxicities. The pharmacokinetic (PK) portion of the HT-001 Phase 2 clinical program has been completed, and the Company is currently awaiting finalized PK results. Additional portions of the Phase 2 program remain ongoing.As management's primary focus shifts toward the execution of Rocket One's technology strategy, the Company is evaluating a range of strategic alternatives for its biotechnology assets, including HT-001 and its other candidates and intellectual property. These alternatives may include partnerships, licensing transactions, joint ventures, asset sales, or other strategic opportunities designed to maximize shareholder value.No decision has been made regarding any specific transaction, and there can be no assurance that any partnership, licensing arrangement, or sale will occur. However, management believes the biotechnology portfolio represents a potentially valuable collection of clinical-stage assets and intellectual property that may be attractive to strategic partners while allowing Rocket One to focus on its long-term technology strategy.Looking AheadRocket One believes that meaningful value creation may come from a combination of internal technology development, strategic partnerships, licensing opportunities, and disciplined capital deployment.In addition to advancing its licensed technology portfolio, Rocket One intends to evaluate strategic acquisitions, partnerships, and licensing opportunities that complement the Company's focus on advanced computing, artificial intelligence infrastructure, space systems, and defense technologies.Management believes the current market environment presents opportunities to identify technologies, intellectual property, engineering capabilities, and operating businesses that may accelerate Rocket One's long-term growth objectives. The Company intends to remain disciplined in evaluating potential opportunities and will focus on transactions that strengthen its strategic positioning and enhance long-term shareholder value.Our objective is to unlock value from both sides of the business—advancing Rocket One's AI and advanced-computing strategy while exploring strategic alternatives that may maximize the value of our biotechnology portfolio.We appreciate the continued support of our shareholders as we pursue this vision and work to build long-term value.Sincerely,Robb Knie
Chief Executive Officer
Rocket One Inc.
Nasdaq: RKTOAbout Rocket One Inc.
Rocket One Inc. is focused on developing and commercializing infrastructure for the orbital economy, including next-generation nanomagnetic AI chip technology designed for radiation-tolerant, energy-constrained environments such as low-Earth orbit, deep-space platforms, and defense systems. The Company holds exclusive rights to certain technologies, including a nanomagnetic matrix multiplier architecture intended as a hardware accelerator for machine learning and AI workloads, and related magnetic memory technology with potential applications in radiation-tolerant computing for defense and space systems. The Company is also positioned to pursue opportunities in nano-launch systems and nanosatellite deployment. The Company's biotechnology pipeline, including, but not limited to, HT-001, HT-KIT, HT-ALZ, and its GDNF-based metabolic program, will continue to be advanced under a wholly owned subsidiary.Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements regarding the Company's strategic repositioning, the development potential of the licensed technologies, the suitability of those technologies for orbital, defense, and other applications, anticipated future operations and market opportunities. 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. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These forward-looking statements are based on the Company's current expectations and assumptions and are subject to numerous risks and uncertainties, including, without limitation: the early-stage nature of the licensed technologies, which have not been fabricated as integrated devices, validated in space environments, or qualified for any commercial or government program, and the absence of any commercial product; the substantial additional capital the Company will require to fabricate, test, and qualify the licensed technologies, including for radiation tolerance and space deployment; the long development timelines associated with novel semiconductor and materials platforms; competition from larger, better-funded and well recognized companies in the semiconductor, AI hardware, space, and defense computing sectors; the Company's ability to recruit qualified leadership and technical personnel in nanomagnetic devices, semiconductor engineering, and aerospace systems; the Company's ability to comply with diligence milestones under the Virginia Commonwealth University license agreements, the failure of which could result in loss of license rights; intellectual property risks; export control and government contracting risks associated with defense and space applications; and the risks inherent in a strategic pivot. Additional risk factors are described in the Company's filings with the Securities and Exchange Commission ("SEC") including the Company's most recent Annual Report on Form 10-K and the Company's other filings made with the SEC. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. The Company may not realize its expectations, and its beliefs may not prove correct. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as the Company's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance, or achievements. The Company 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 @jtdiii
www.rocketone.space View original content to download multimedia:https://www.prnewswire.com/news-releases/rocket-one-reports-approximately-8-4-million-in-cash-and-cash-equivalents-and-outlines-strategy-across-ai-infrastructure-spintronic-computing-for-space-and-defense-markets-302800258.htmlSOURCE Rocket One Inc. Original: Rocket One Reports Approximately $8.4 Million in Cash and Cash Equivalents and Outlines Strategy Across AI Infrastructure, Spintronic Computing for Space and Defense Markets
US Market News
3週前
ROCKET ONE APPOINTS MAJOR GENERAL MALCOLM B. FROST (RET.) TO SPACE AND DEFENSE ADVISORY BOARDJune 3, 2026 8:22 AM
PR Newswire (US) Former U.S. Army Major General Brings Decades of National Security, Strategic Operations, and Defense Leadership Experience to Support Rocket One's Expansion into AI Infrastructure for Space, and Defense ApplicationsHOBOKEN, N.J., June 3, 2026 /PRNewswire/ -- (Nasdaq: RKTO) Rocket One, Inc. ("Rocket One" or the "Company"), a technology company focused on next-generation AI computing, advanced semiconductor technologies, and space and defense applications, today announced the appointment of Major General Malcolm B. Frost (Ret.) to its Space and Defense Advisory Board. General Frost brings nearly four decades of military, national security, and leadership experience, including 31 years of distinguished service in the United States Army. Throughout his career, he held senior operational, strategic, and communications leadership positions across the Indo-Pacific, Middle East, Europe, and the United States."General Frost's experience leading large-scale military operations, strategic planning initiatives, and national defense programs makes him an exceptional addition to Rocket One's advisory board," said Robb Knie, Chief Executive Officer of Rocket One. "As we pursue opportunities at the intersection of artificial intelligence, advanced computing, space infrastructure, and defense technologies, his leadership and insight will help guide our long-term strategy and strengthen our relationships across the defense and national security ecosystem."During his military career, General Frost served as Chief of Public Affairs for the U.S. Army, leading strategic communications for an organization of approximately 1.5 million personnel. He also served as Deputy Director for Operations at the Department of Defense's National Military Command Center and as Director of Operations for U.S. Army Pacific, overseeing operational planning, security cooperation initiatives, and multinational military exercises throughout the Indo-Pacific region.In his final Army assignment, General Frost led the Army's Initial Entry Training enterprise, overseeing the transformation of approximately 130,000 civilian volunteers into soldiers annually while also helping lead the Army's holistic health and fitness modernization efforts."I am excited to join Rocket One's Space and Defense Advisory Board at a time when advanced computing, artificial intelligence, and resilient infrastructure are becoming increasingly important to national security," said General Frost. "Rocket One is pursuing technologies that have the potential to support future defense, aerospace, and space-based computing applications, and I look forward to contributing to the Company's strategic growth."Rocket One is developing a platform focused on advanced computing technologies designed to address emerging opportunities in artificial intelligence acceleration, radiation-tolerant computing, space systems, and defense applications. The Company believes that increasing demand for secure, energy-efficient, and resilient computing infrastructure will create opportunities across both commercial and government markets.General Frost currently serves as a corporate advisor, executive coach, keynote speaker, and board member for public and private organizations spanning artificial intelligence, defense, healthcare, energy, and strategic communications sectors. He is a graduate of the United States Military Academy at West Point and holds advanced degrees in Human Resources Development and National Security Strategy.About Rocket One Inc.
Rocket One Inc. is focused on developing and commercializing infrastructure for the orbital economy, including next-generation nanomagnetic AI chip technology designed for radiation-tolerant, energy-constrained environments such as low-Earth orbit, deep-space platforms, and defense systems. The Company holds exclusive rights to certain technologies, including a nanomagnetic matrix multiplier architecture intended as a hardware accelerator for machine learning and AI workloads, and related magnetic memory technology with potential applications in radiation-tolerant computing for defense and space systems. The Company is also positioned to pursue opportunities in nano-launch systems and nanosatellite deployment. The Company's biotechnology pipeline, including, but not limited to, HT-001, HT-KIT, HT-ALZ, and its GDNF-based metabolic program, will continue to be advanced under a wholly owned subsidiary.Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements regarding the Company's strategic repositioning, the development potential of the licensed technologies, the suitability of those technologies for orbital, defense, and other applications, anticipated future operations and market opportunities. 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. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These forward-looking statements are based on the Company's current expectations and assumptions and are subject to numerous risks and uncertainties, including, without limitation: the early-stage nature of the licensed technologies, which have not been fabricated as integrated devices, validated in space environments, or qualified for any commercial or government program, and the absence of any commercial product; the substantial additional capital the Company will require to fabricate, test, and qualify the licensed technologies, including for radiation tolerance and space deployment; the long development timelines associated with novel semiconductor and materials platforms; competition from larger, better-funded and well recognized companies in the semiconductor, AI hardware, space, and defense computing sectors; the Company's ability to recruit qualified leadership and technical personnel in nanomagnetic devices, semiconductor engineering, and aerospace systems; the Company's ability to comply with diligence milestones under the Virginia Commonwealth University license agreements, the failure of which could result in loss of license rights; intellectual property risks; export control and government contracting risks associated with defense and space applications; and the risks inherent in a strategic pivot. Additional risk factors are described in the Company's filings with the Securities and Exchange Commission ("SEC") including the Company's most recent Annual Report on Form 10-K and the Company's other filings made with the SEC. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. The Company may not realize its expectations, and its beliefs may not prove correct. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as the Company's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance, or achievements. The Company 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 @jtdiii
www.rocketone.space View original content to download multimedia:https://www.prnewswire.com/news-releases/rocket-one-appoints-major-general-malcolm-b-frost-ret-to-space-and-defense-advisory-board-302789753.htmlSOURCE Rocket One Inc. Original: ROCKET ONE APPOINTS MAJOR GENERAL MALCOLM B. FROST (RET.) TO SPACE AND DEFENSE ADVISORY BOARD
US Market News
3週前
Rocket One Appoints Dr. Supriyo Bandyopadhyay as Lead Technical Advisor of AI Nanomagnetic TechnologyJune 1, 2026 10:18 AM
PR Newswire (US) Pioneering nanomagnetics researcher to guide development of the company's radiation-tolerant, ultra-low-power AI chip platformNEW YORK, June 1, 2026 /PRNewswire/ -- Rocket One Inc. (Nasdaq: RKTO) today announced the appointment of Dr. Supriyo Bandyopadhyay as Lead Technical Advisor of AI Nanomagnetic Technology. In this role, Dr. Bandyopadhyay will guide the technical development of the company's nanomagnetic AI chip technology as Rocket One builds infrastructure for the orbital economy, including AI computing and memory hardware engineered for space and defense environments. Dr. Bandyopadhyay is a Commonwealth Professor of Electrical and Computer Engineering at Virginia Commonwealth University and a leading authority on nanomagnetics and spintronics, the scientific foundations underlying Rocket One's licensed nanomagnetic matrix multiplier architecture. His appointment deepens the technical link between Rocket One's platform and the foundational research from which it is derived."Dr. Bandyopadhyay's work sits at the very heart of what makes our technology possible," said Robb Knie, Chief Executive Officer of Rocket One. "As we move from a launch story to a compute story, having one of the field's foremost researchers guiding our roadmap gives us a credible technical foundation to build on for orbital and high-radiation environments.""Rocket One is pursuing exactly the kind of real-world application this technology was designed for—computing that can think for itself under power and radiation constraints that conventional hardware cannot handle," said Dr. Bandyopadhyay. "I look forward to helping translate years of foundational research into deployable systems for space and defense."About Rocket One Inc.
Rocket One Inc. is focused on developing and commercializing infrastructure for the orbital economy, including next-generation nanomagnetic AI chip technology designed for radiation-tolerant, energy-constrained environments such as low-Earth orbit, deep-space platforms, and defense systems. The Company holds exclusive rights to certain technologies, including a nanomagnetic matrix multiplier architecture intended as a hardware accelerator for machine learning and AI workloads, and related magnetic memory technology with potential applications in radiation-tolerant computing for defense and space systems. The Company is also positioned to pursue opportunities in nano-launch systems and nanosatellite deployment. The Company's biotechnology pipeline, including, but not limited to, HT-001, HT-KIT, HT-ALZ, and its GDNF-based metabolic program, will continue to be advanced under a wholly owned subsidiary.Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements regarding the Company's strategic repositioning, the development potential of the licensed technologies, the suitability of those technologies for orbital, defense, and other applications, anticipated future operations and market opportunities. 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. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These forward-looking statements are based on the Company's current expectations and assumptions and are subject to numerous risks and uncertainties, including, without limitation: the early-stage nature of the licensed technologies, which have not been fabricated as integrated devices, validated in space environments, or qualified for any commercial or government program, and the absence of any commercial product; the substantial additional capital the Company will require to fabricate, test, and qualify the licensed technologies, including for radiation tolerance and space deployment; the long development timelines associated with novel semiconductor and materials platforms; competition from larger, better-funded and well recognized companies in the semiconductor, AI hardware, space, and defense computing sectors; the Company's ability to recruit qualified leadership and technical personnel in nanomagnetic devices, semiconductor engineering, and aerospace systems; the Company's ability to comply with diligence milestones under the Virginia Commonwealth University license agreements, the failure of which could result in loss of license rights; intellectual property risks; export control and government contracting risks associated with defense and space applications; and the risks inherent in a strategic pivot. Additional risk factors are described in the Company's filings with the Securities and Exchange Commission ("SEC") including the Company's most recent Annual Report on Form 10-K and the Company's other filings made with the SEC. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. The Company may not realize its expectations, and its beliefs may not prove correct. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as the Company's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance, or achievements. The Company 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 @jtdiii
www.rocketone.space View original content to download multimedia:https://www.prnewswire.com/news-releases/rocket-one-appoints-dr-supriyo-bandyopadhyay-as-lead-technical-advisor-of-ai-nanomagnetic-technology-302787186.htmlSOURCE Rocket One Inc. Original: Rocket One Appoints Dr. Supriyo Bandyopadhyay as Lead Technical Advisor of AI Nanomagnetic Technology
iHub News
4週前
Rocket One Rebrand Marks Strategic Shift Toward Space AI Chip and Orbital Computing Markets (RKTO)May 27, 2026 11:49 AM
IH Market News Hoth Therapeutics is rebranding as Rocket One and pivoting toward space-focused AI chip infrastructure, targeting low-power, radiation-tolerant computing systems for orbital and defense applications. Key Investor Takeaways Hoth Therapeutics (NASDAQ:HOTH) will begin trading as Rocket One Inc. under the ticker symbol (NASDAQ:RKTO) on May 28, 2026. The company is repositioning around nanomagnetic AI chip technology designed for space and defense computing environments. Rocket One said it holds exclusive rights to low-power, radiation-tolerant AI chip and memory technologies. Management is targeting growth opportunities tied to satellites, orbital AI systems, nanosatellites, and defense infrastructure. The company’s biotechnology programs will continue operating under a wholly owned subsidiary. Why RKTO Stock Is in Focus Hoth Therapeutics announced it has officially changed its corporate name to Rocket One Inc. and will begin trading under the Nasdaq ticker symbol RKTO beginning May 28, 2026. The rebrand follows the company’s previously disclosed strategic repositioning toward the orbital economy and space-based computing infrastructure. According to Rocket One, the company is focusing on next-generation nanomagnetic AI chip technology designed for energy-constrained and radiation-heavy environments such as: low-Earth orbit deep-space platforms satellites defense systems The company said the technology differs from traditional silicon-based chips by using nanoscale magnetism to perform AI-related computations. Rocket One highlighted several intended advantages of the technology, including: retention of data without continuous power reduced energy consumption smaller hardware footprint edge AI processing capabilities for satellites and defense applications Management said the company intends to pursue three primary strategic areas: AI chip and memory hardware for orbital and radiation-heavy environments Nano-launch and nanosatellite systems Defense and national security applications The company also stated that its biotechnology programs, including HT-001, HT-KIT, HT-ALZ, and its GDNF-related metabolic platform, will continue under a wholly owned subsidiary structure. “Space is moving from a launch story to a compute story,” said Chief Executive Officer Robb Knie. “We believe that the platforms that will define the next decade in orbit will be the ones that can think for themselves under power and radiation constraints that ground-based hardware was never designed to handle.” Knie added: “Our exclusive licenses give us a credible technical foundation, and the RKTO ticker is a signal to investors, partners, and customers that our focus is now on the orbital economy.” Why This Matters for Investors The announcement represents a major strategic transformation for the company, shifting investor focus away from biotechnology and toward space infrastructure and AI hardware markets. The move positions Rocket One within several high-profile investment themes simultaneously, including: space economy infrastructure AI hardware defense technology edge computing satellite systems The company appears to be targeting a specific challenge facing modern satellite and orbital systems: running AI workloads efficiently under strict energy and radiation constraints. For investors, the repositioning could potentially broaden Rocket One’s addressable market if the company successfully commercializes its nanomagnetic computing technology. However, the transition also introduces substantial execution risk. The company is entering highly competitive and technically demanding industries dominated by established semiconductor, aerospace, and defense players. The release also does not include: commercialization timelines production milestones customer agreements revenue projections prototype validation data As a result, investor sentiment may remain tied largely to future technical progress and partnership development rather than near-term financial performance. The continuation of the biotech pipeline under a subsidiary structure may also leave investors evaluating how management allocates resources across two very different operating segments. What to Watch Next Investors may monitor: Technical validation milestones for the nanomagnetic AI chip platform Potential aerospace or defense partnerships Progress in nanosatellite and orbital computing initiatives Commercialization strategy for AI hardware Government or national security contract opportunities Future disclosures around prototypes, testing, or manufacturing The operational structure separating biotech and space-focused businesses Hoth Therapeutics stock price Original: Rocket One Rebrand Marks Strategic Shift Toward Space AI Chip and Orbital Computing Markets (RKTO)
US Market News
4週前
Hoth Therapeutics Becomes Rocket One Inc. (Nasdaq: RKTO), Targeting the Space Economy with Next-Generation Nanomagnetic AI Chip Technology and Ultra-Low-Power, Radiation-Tolerant Computing for Space and Defense ApplicationsMay 27, 2026 8:11 AM
PR Newswire (US) Company Adopts Space-Focused Identity, New Ticker "RKTO," and Exclusive License of AI Chip Architecture Designed for Ultra-Low-Power, Radiation-Tolerant Computing in Space and Defense ApplicationsHOBOKEN, N.J., May 27, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH) ("Hoth" or the "Company") today announced that, following the strategic repositioning disclosed on May 19, 2026, it has completed the legal change of its corporate name to Rocket One Inc. ("Rocket One") effective as of May 26, 2026 and will begin trading on The Nasdaq Capital Market under the new ticker symbol "RKTO" at the open of trading on May 28, 2026. The Company's common stock will cease trading under the symbol "HOTH" at the close of trading on May 27, 2026. The Rocket One identity reflects the Company's strategic focus on the orbital economy: the next generation of satellites, defense platforms, and space-based AI systems that depend on hardware capable of operating reliably in space. The Company's legacy biotechnology programs will continue to be advanced under a wholly owned subsidiary.Why Space, and Why NowThe commercial space sector is undergoing a structural shift. Falling launch costs, the rapid growth of small satellites, and rising defense demand for resilient orbital assets are creating a new layer of infrastructure above the atmosphere. As more workloads move from ground stations to spacecraft — from Earth observation and signal processing to autonomous navigation and on-orbit AI — the limiting factor is no longer getting to orbit. It is the ability to run powerful computing on satellites that have very little power available, generate heat that is hard to dissipate, and operate in an environment of constant radiation.Today's standard computer chips are designed for terrestrial data centers, not for low-Earth orbit. They consume power satellites cannot spare, lose data when the satellite power cycles on and off, and require heavy shielding to survive radiation. Rocket One is positioning itself directly at this bottleneck.The Technology PlatformRocket One holds exclusive rights to a next-generation nanomagnetic AI chip technology. Unlike conventional chips that move electrons through silicon, this new class of chip uses magnetism at the nanoscale to perform the core calculations that drive artificial intelligence.Properties of the technology that make it especially well-suited for space and defense applications include:Holds data without power. The chip retains computational results even when powered off, intended to eliminate data loss during satellite power cycles and eclipse periods.Extremely low energy use. The design targets dramatically lower energy per calculation than conventional AI chips, intended to address the severe power limits of small satellites and deep-space platforms.Very small footprint. Each compute cell occupies only a tiny fraction of the area of a conventional chip element, supporting the strict mass and volume constraints of nanosatellite payloads.Built for edge AI. Computing on the device itself reduces dependence on ground-link bandwidth and limits exposure to interception or jamming — increasingly valued by defense and national security customers.Rocket One's Strategic ApertureBuilding on the previously disclosed formation of its space subsidiary, now Rocket One.0 Inc., Rocket One intends to pursue three converging opportunities: (i) AI chip and memory hardware engineered for orbital and high-radiation environments; (ii) nano-launch and nanosatellite enablement; and (iii) defense and national security applications where radiation tolerance, energy efficiency, and on-device intelligence intersect. The Company believes these markets are mutually reinforcing and that its licensed nanomagnetic chip platform offers a differentiated entry point into each.What Stockholders Should KnowNew Corporate Name: Rocket One Inc.New Ticker Symbol: RKTO (Nasdaq Capital Market)Former Ticker Symbol: HOTH (Nasdaq Capital Market)Effective Date of Name Change: May 26, 2026Effective Date of Ticker Symbol Change: May 28, 2026CUSIP: 44148G204 (no change)Corporate Website: www.rocketone.space Management Commentary"Space is moving from a launch story to a compute story. We believe that the platforms that will define the next decade in orbit will be the ones that can think for themselves under power and radiation constraints that ground-based hardware was never designed to handle. The rebrand to Rocket One reflects where we are positioning this Company," said Robb Knie, Chief Executive Officer. Knie continued, "Our exclusive licenses give us a credible technical foundation, and the RKTO ticker is a signal to investors, partners, and customers that our focus is now on the orbital economy."About Rocket One Inc.Rocket One Inc. (formerly Hoth Therapeutics, Inc.) is focused on developing and commercializing infrastructure for the orbital economy, including next-generation nanomagnetic AI chip technology designed for radiation-tolerant, energy-constrained environments such as low-Earth orbit, deep-space platforms, and defense systems. The Company holds exclusive rights to certain technologies, including a nanomagnetic matrix multiplier architecture intended as a hardware accelerator for machine learning and AI workloads, and related magnetic memory technology with potential applications in radiation-tolerant computing for defense and space systems. The Company is also positioned to pursue opportunities in nano-launch systems and nanosatellite deployment. The Company's biotechnology pipeline, including, but not limited to, HT-001, HT-KIT, HT-ALZ, and its GDNF-based metabolic program, will continue to be advanced under a wholly owned subsidiary.Forward-Looking StatementsThis press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements regarding the Company's strategic repositioning, the development potential of the licensed technologies, the suitability of those technologies for orbital, defense, and other applications, anticipated future operations and market opportunities. 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. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These forward-looking statements are based on the Company's current expectations and assumptions and are subject to numerous risks and uncertainties, including, without limitation: the early-stage nature of the licensed technologies, which have not been fabricated as integrated devices, validated in space environments, or qualified for any commercial or government program, and the absence of any commercial product; the substantial additional capital the Company will require to fabricate, test, and qualify the licensed technologies, including for radiation tolerance and space deployment; the long development timelines associated with novel semiconductor and materials platforms; competition from larger, better-funded and well recognized companies in the semiconductor, AI hardware, space, and defense computing sectors; the Company's ability to recruit qualified leadership and technical personnel in nanomagnetic devices, semiconductor engineering, and aerospace systems; the Company's ability to comply with diligence milestones under the Virginia Commonwealth University license agreements, the failure of which could result in loss of license rights; intellectual property risks; export control and government contracting risks associated with defense and space applications; and the risks inherent in a strategic pivot. Additional risk factors are described in the Company's filings with the Securities and Exchange Commission ("SEC") including the Company's most recent Annual Report on Form 10-K and the Company's other filings made with the SEC. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. The Company may not realize its expectations, and its beliefs may not prove correct. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as the Company's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance, or achievements. The Company 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 ContactLR Advisors LLC
Email: investorrelations @jtdiii
www.rocketone.space View original content to download multimedia:https://www.prnewswire.com/news-releases/hoth-therapeutics-becomes-rocket-one-inc-nasdaq-rkto-targeting-the-space-economy-with-next-generation-nanomagnetic-ai-chip-technology-and-ultra-low-power-radiation-tolerant-computing-for-space-and-defense-applications-302782323.htmlSOURCE Hoth Therapeutics, Inc. Original: Hoth Therapeutics Becomes Rocket One Inc. (Nasdaq: RKTO), Targeting the Space Economy with Next-Generation Nanomagnetic AI Chip Technology and Ultra-Low-Power, Radiation-Tolerant Computing for Space and Defense Applications
US Market News
4週前
Hoth Therapeutics Awarded U.S. Patent for Cancer-Fighting HT-KIT Oncology PlatformMay 26, 2026 8:18 AM
PR Newswire (US) Allowed Claims Cover Composition-of-Matter and Methods Targeting MS4A6A Pre-mRNA Splicing to Reduce Surface Expression of the High-Affinity IgE Receptor (FceRI); Strengthens Intellectual Property Foundation Underlying the HT-KIT Mast Cell ProgramHOBOKEN, N.J., May 26, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH) ("Hoth" or the "Company"), a clinical-stage biopharmaceutical company, today announced that the U.S. Patent and Trademark Office ("USPTO") has issued a Notice of Allowance for Hoth's HT-KIT therapeutic. The allowed claims cover antisense oligomers of 25 to 50 linked nucleosides directed to splicing-relevant regions of the MS4A6A pre-mRNA, including intron 3, exon 4, and the intron 3/exon 4 junction, together with pharmaceutical compositions and methods for modulating MS4A6A mRNA splicing in cells or tissues. Hybridization of the disclosed oligomers is intended to reduce cell-surface expression of the high-affinity IgE receptor (FceRI), a central driver of mast cell activation in allergic and inflammatory disease.Strategic ImportanceFoundational IP Position. Allowance establishes composition-of-matter coverage for the Company's lead antisense oligomer (SEQ ID NO: 22), including modified, morpholino, and pharmaceutical composition embodiments, providing a defensible basis for the underlying chemistry of the platform.Mechanistic Differentiation. By reducing surface expression of FceRI via exon-skipping of MS4A6A pre-mRNA, the approach addresses a node upstream of histamine release and IgE-mediated degranulation, distinct from antihistamine, anti-IgE antibody, and small-molecule mast cell inhibitor approaches.Broad Indication Coverage. Allowed method claims and related disclosures span asthma, atopic dermatitis, chronic rhinitis, allergic conjunctivitis, chronic sinusitis, anaphylaxis prevention, and mast cell–driven diseases including mastocytosis and mast cell tumors.Reinforces HT-KIT. The allowed claims strengthen the intellectual property foundation underlying HT-KIT, the Company's orphan drug–designated program for mast cell–driven disease.Combination Optionality. The application as filed also describes combination approaches with antisense oligomers targeting FceRIß (MS4A2) pre-mRNA splicing, supporting future development of dual-target compositions.Management Commentary"This Notice of Allowance is a meaningful validation of the science underlying our mast cell platform and an important addition to the intellectual property foundation supporting HT-KIT," said Robb Knie, Chief Executive Officer of Hoth Therapeutics.About HT-KITHT-KIT is Hoth Therapeutics' orphan drug–designated program directed at mastocytosis and other mast cell–driven diseases. The program is built around antisense oligomer–mediated modulation of pre-mRNA splicing to reduce pathological mast cell signaling. Hoth expects to finalize its IND submission in 2026, followed by first-in-human studies.Biotechnology Operations Continue Under Subsidiary Structure
The Company 's is exploring placing its biotechnology pipeline and therapeutic development programs under a separate, wholly owned subsidiary with dedicated management and operational resources. The restructuring is intended to preserve the value of the biotechnology portfolio for shareholders while enabling the parent company to pursue emerging opportunities in AI semiconductor infrastructure and advanced computing technologies.About Rocket One, Inc.
Rocket One Inc. is focused on the development and commercialization of spintronic computing technologies for artificial intelligence hardware acceleration and radiation-tolerant computing applications. The Company holds exclusive rights to technologies licensed for nanomagnetic matrix multiplier architecture designed as a hardware accelerator for machine learning and artificial intelligence workloads, and a skyrmion-based spintronic memory technology with potential applications in radiation-tolerant computing for defense and space systems.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-awarded-us-patent-for-cancer-fighting-ht-kit-oncology-platform-302781296.htmlSOURCE Hoth Therapeutics, Inc. Original: Hoth Therapeutics Awarded U.S. Patent for Cancer-Fighting HT-KIT Oncology Platform
US Market News
1月前
AI Chip Energy Efficiency: Hoth Therapeutics Restructures as Rocket One Inc. to Enter the AI Semiconductor Infrastructure Market with Acquisition of Exclusive Rights to Next Generation AI Semiconductor Acceleration Technology Built on Non-Volatile NanomagnMay 19, 2026 8:17 AM
PR Newswire (US) Company Targets Power Demands of AI Data Centers Through Patented Nanomagnetic Semiconductor and Spintronic Computing Technologies for AI, Defense, and Space ApplicationsHOBOKEN, N.J., May 19, 2026 /PRNewswire/ -- (NASDAQ: HOTH) ("Hoth" or the "Company") today announced that it intends to change its name to Rocket One, Inc. ("Rocket One"), and to restructure its business to position the Company, through its recently formed wholly-owned subsidiary, to pursue opportunities in artificial intelligence infrastructure, next-generation semiconductor technologies, and ultra-low-power AI computing. Under its soon to be newly rebranded name, Rocket One, Inc., and the newly obtained licenses, the Company will enter the expanding AI semiconductor market, with exclusive rights to AI Semiconductor Acceleration Technology Built on Non-Volatile Nanomagnetic Semiconductor Architecture and to spintronic computing technologies developed at Virginia Commonwealth University ("VCU") targeting one of the largest challenges facing artificial intelligence today: power consumption and computing efficiency.The Company intends to continue its biotechnology programs and is exploring placing its biotechnology assets in a separate, wholly owned subsidiary.The refocusing of the business was unanimously approved by the Company's Board of Directors. Additional details regarding the licenses and proposed business will be included in a Current Report on Form 8-K that will be filed timely with the Securities and Exchange Commission.AI Infrastructure Is Reaching a Breaking PointArtificial intelligence has become the defining workload of modern computing, driving an unprecedented global buildout of AI data centers, autonomous systems, edge AI infrastructure, and high-performance computing environments.But the AI industry is increasingly constrained by:escalating power consumptioncooling limitationsmemory bottlenecksinference latencyrising infrastructure costsAs demand for large language models, generative AI, and autonomous systems accelerates globally, the world's largest technology companies are actively searching for next-generation semiconductor architectures capable of delivering dramatically improved efficiency beyond conventional silicon approaches.The Company believes solving these infrastructure constraints represents one of the most significant opportunities in the future of artificial intelligence.Exclusive AI Semiconductor and Spintronic Computing PortfolioRocket One has secured exclusive rights to what it believes are two complementary spintronic semiconductor technologies. And
Nanomagnetic Matrix Multiplier — AI Hardware AccelerationThe Company secured exclusive rights to
"A compact, low-energy, non-volatile nanomagnetic matrix multiplier as a hardware accelerator for machine learning and artificial intelligence."Matrix multiplication is the foundational operation underlying virtually all modern AI workloads, including transformer architectures powering large language models and generative artificial intelligence systems.The licensed architecture is designed to support:ultra-low-power AI accelerationnext-generation AI inferenceadvanced memory efficiencyedge AI systemsintelligent autonomous platformsdistributed AI infrastructureThe second technology utilizes electron spin rather than conventional charge-based semiconductor approaches and is intended to address growing energy efficiency constraints in AI computing infrastructure.Spintronic Memory Platform — Defense, Autonomous Systems, and Space ComputingRocket One secured exclusive rights to spintronic memory technologies designed for advanced computing and information processing applications with potential relevance to:radiation-tolerant computingdefense infrastructureautonomous aerospace systemsresilient edge computeorbital AI environmentsnext-generation intelligent systemsThe Company believes the same underlying spintronic physics supporting AI acceleration may also provide long-term opportunities across defense and space-based computing infrastructure markets.Building an AI Infrastructure PlatformThe Company intends to pursue a capital-efficient growth strategy focused on:semiconductor infrastructure partnershipsAI hardware commercializationsponsored researchstrategic acquisitionsdefense and aerospace opportunitiesadvanced compute infrastructureintelligent edge systemsThe Company also plans to expand leadership with expertise spanning:semiconductor operationsAI infrastructureadvanced computing architecturesdefense technologieshigh-performance computingManagement Commentary"Artificial intelligence is rapidly transforming every major industry, but the infrastructure powering AI is approaching critical energy and efficiency limits," said Robb Knie, Chief Executive Officer.
"We believe next-generation semiconductor architectures capable of dramatically improving power efficiency, memory performance, and intelligent computing scalability represent one of the largest opportunities in global technology today. Rocket One is being built to position the Company to participate in the future of AI infrastructure."Biotechnology Operations Continue Under Subsidiary StructureThe Company 's is exploring placing its biotechnology pipeline and therapeutic development programs under a separate, wholly owned subsidiary with dedicated management and operational resources. The restructuring is intended to preserve the value of the biotechnology portfolio for shareholders while enabling the parent company to pursue emerging opportunities in AI semiconductor infrastructure and advanced computing technologies.About Rocket One, Inc.
Rocket One Inc. is focused on the development and commercialization of spintronic computing technologies for artificial intelligence hardware acceleration and radiation-tolerant computing applications. The Company holds exclusive rights to technologies licensed for nanomagnetic matrix multiplier architecture designed as a hardware accelerator for machine learning and artificial intelligence workloads, and a skyrmion-based spintronic memory technology with potential applications in radiation-tolerant computing for defense and space systems.Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the Company's corporate restructuring, strategic direction, the development potential of the licensed technologies, anticipated future operations, planned hires, planned acquisitions, planned research relationships, and the market opportunities described herein. These forward-looking statements are based on the Company's current expectations and assumptions and are subject to numerous risks and uncertainties. Risks include, without limitation: the early-stage nature of the licensed technologies and the absence of any commercial product; the substantial additional capital the Company will require to execute its strategic plan; the Company's ability to raise such capital on acceptable terms or at all; competition from larger and better-funded companies in the semiconductor, AI hardware, and defense computing sectors; the Company's ability to recruit and retain qualified leadership and technical personnel; the Company's ability to identify, finance, and complete strategic acquisitions on acceptable terms; the Company's ability to comply with diligence milestones under the VCU license agreements, the failure of which could result in loss of license rights; intellectual property risks, including that one of the licensed patents is a patent application that has not yet issued and may issue, if at all, with claims narrower than currently sought; government use rights and other limitations on the licensed technologies arising from federal research funding under the Bayh-Dole Act; uncertainties in the demand for spintronic computing solutions; the risks of operating in a regulated industry; and the risks inherent in a corporate restructuring, including those affecting the Company's existing biotechnology operations and shareholder base.Additional risk factors are described in the Company's filings with the Securities and Exchange Commission, including the Form 8-K filed concurrently with this press release and the Company's most recent Annual Report on Form 10-K and subsequent quarterly reports. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update such statements except as required by 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/ai-chip-energy-efficiency-hoth-therapeutics-restructures-as-rocket-one-inc-to-enter-the-ai-semiconductor-infrastructure-market-with-acquisition-of-exclusive-rights-to-next-generation-ai-semiconductor-acceleration-technology-buil-302776054.htmlSOURCE Hoth Therapeutics, Inc. Original: AI Chip Energy Efficiency: Hoth Therapeutics Restructures as Rocket One Inc. to Enter the AI Semiconductor Infrastructure Market with Acquisition of Exclusive Rights to Next Generation AI Semiconductor Acceleration Technology Built on Non-Volatile Nanomagn
US Market News
2月前
Hoth Therapeutics Secures European Authorization in Spain for HT-001 Phase 2a Trial as Interim Data Show Strong Efficacy in Cancer PatientsMay 5, 2026 4:17 PM
PR Newswire (US) Regulatory Clearance in Spain Advances Randomized, Placebo-Controlled Study; Patients Show Meaningful Reductions in EGFR-Inhibitor Skin Toxicities with No Treatment Disruptions
NEW YORK, May 5, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, today announced that it has secured regulatory authorization in Spain for its Phase 2a CLEER Trial of HT-001, while concurrently reporting encouraging interim clinical results demonstrating meaningful efficacy and safety in cancer patients experiencing EGFR inhibitor-associated skin toxicities. The authorization supports the continued advancement of Hoth's randomized, placebo-controlled, dose-ranging Phase 2a study evaluating HT-001 for the treatment of dermatologic toxicities associated with epidermal growth factor receptor (EGFR) inhibitor therapies.Interim Clinical Results Highlight Strong Efficacy SignalPreliminary data from the ongoing study indicate:Patients achieved the primary efficacy endpoint, with rash severity reduced to clinically manageable levels (ARIGA ≤1) by Week 6Over 65% of patients reported meaningful reductions in pain and itchingZero patients required dose reduction or discontinuation of their underlying EGFR inhibitor cancer therapyFavorable safety profile, with no treatment-limiting adverse events observedThese findings suggest that HT-001 may enable patients to remain on life-saving cancer therapies longer, addressing a major limitation of current oncology treatment regimens.Regulatory Momentum + Clinical Validation
"Regulatory advancement paired with strong clinical signals has helped open up a new avenue for patients in Spain," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Securing European authorization while demonstrating meaningful patient benefit reinforces our belief that HT-001 has the potential to become a critical supportive care therapy in oncology."The Spain authorization marks an important step in Hoth's European strategy and supports continued trial execution and expansion across additional regions.About the CLEER Trial
The CLEER Trial (Chemotherapy Longevity by Evading EGFR Inhibitor Reactions) is a Phase 2a randomized, placebo-controlled, parallel, dose-ranging study evaluating HT-001 in patients experiencing EGFR inhibitor-related dermatologic toxicities.About HT-001
HT-001 is a novel topical therapeutic designed to target inflammatory pathways associated with cancer therapy-induced skin toxicities, with the goal of improving tolerability and enabling uninterrupted treatment.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-secures-european-authorization-in-spain-for-ht-001-phase-2a-trial-as-interim-data-show-strong-efficacy-in-cancer-patients-302762976.htmlSOURCE Hoth Therapeutics, Inc. Original: Hoth Therapeutics Secures European Authorization in Spain for HT-001 Phase 2a Trial as Interim Data Show Strong Efficacy in Cancer Patients
US Market News
2月前
Hoth Therapeutics (HOTH) Reports Positive HT-VA CRADA Data: GDNF Reprograms Liver Fat Metabolism, Shuts Down Fat-Creation Gene and Activates Fat-Burning Pathways, Outperforming SemaglutideApril 14, 2026 7:00 AM
PR Newswire (US)
Statistically Significant Reduction in Srebf1 (Fat Production) and Increased Ppara (Fat Metabolism) Position GDNF as Next-Generation Therapy for MAFLD and ObesityNEW YORK, April 14, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, today announced positive data from its HT-VA study, conducted under its Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs and Emory University, demonstrating that parenteral GDNF (Glial Cell-Derived Neurotrophic Factor) directly reprograms liver fat metabolism at the genetic level in a preclinical model of metabolic-associated fatty liver disease (MAFLD).
The data highlights statistically significant improvements in key genes responsible for fat production and fat metabolism, positioning GDNF as a potentially differentiated therapeutic approach targeting the root cause of fatty liver disease and metabolic dysfunction.Statistically significant reduction in Srebf1, a key gene driving fat production in the liverIncreased expression of Ppara, a central regulator of fat metabolism and fat burningGDNF outperformed semaglutide in key gene expression markers tied to liver fat regulationDemonstrated broad metabolic impact at the genetic level, not just weight reductionUnlike existing therapies that primarily focus on weight loss, GDNF directly targets the biological mechanisms responsible for fat accumulation in the liver.Srebf1 reduction ? less fat being createdPpara activation ? more fat being burnedNet effect ? reprogramming of liver metabolismThis dual mechanism suggests GDNF may offer a disease-modifying approach for MAFLD, obesity, and related metabolic disorders."HT-VA represents a major milestone for Hoth as we expand into high-value metabolic indications," said Robb Knie, Chief Executive Officer of Hoth Therapeutics."These results demonstrate that GDNF is not simply reducing fat, but fundamentally reprogramming how the body produces and metabolizes fat at the genetic level. The ability to shut down fat creation while activating fat metabolism differentiates GDNF from existing therapies, including GLP-1 agonists."SCIENTIFIC SUMMARY (HT-VA STUDY)The HT-VA study evaluated the effects of parenteral GDNF in a diet-induced obesity and MAFLD model.Key observations include:Western diet significantly increased liver fat accumulation and metabolic dysfunctionGDNF treatment significantly improved liver gene expression linked to fat metabolismReduced lipogenesis signaling (Srebf1) and enhanced metabolic regulation pathways (Ppara)Gene expression changes support improved hepatic lipid handling and metabolic efficiencySTRATEGIC IMPLICATIONSEntry into MAFLD/NASH and obesity markets Differentiation vs. GLP-1 therapies through gene-level mechanismPotential for first-in-class metabolic reprogramming therapyExpansion beyond Hoth's core dermatology and oncology pipeline NEXT STEPSHoth plans to:Advance HT-VA findings into additional preclinical validation studiesEvaluate clinical development pathways for metabolic and liver diseasesExplore strategic partnerships and collaborations to accelerate developmentAbout 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-hoth-reports-positive-ht-va-crada-data-gdnf-reprograms-liver-fat-metabolism-shuts-down-fat-creation-gene-and-activates-fat-burning-pathways-outperforming-semaglutide-302741263.htmlSOURCE Hoth Therapeutics, Inc.
Original: Hoth Therapeutics (HOTH) Reports Positive HT-VA CRADA Data: GDNF Reprograms Liver Fat Metabolism, Shuts Down Fat-Creation Gene and Activates Fat-Burning Pathways, Outperforming Semaglutide
US Market News
2月前
Hoth Therapeutics (HOTH) Reports Positive HT-VA CRADA Data: GDNF Reprograms Liver Fat Metabolism, Shuts Down Fat-Creation Gene and Activates Fat-Burning Pathways, Outperforming SemaglutideApril 13, 2026 5:23 PM
PR Newswire (US)
Statistically Significant Reduction in Srebf1 (Fat Production) and Increased Ppara (Fat Metabolism) Position GDNF as Next-Generation Therapy for MAFLD and ObesityNEW YORK, April 13, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, today announced positive data from its HT-VA study, conducted under its Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs and Emory University, demonstrating that parenteral GDNF (Glial Cell-Derived Neurotrophic Factor) directly reprograms liver fat metabolism at the genetic level in a preclinical model of metabolic-associated fatty liver disease (MAFLD).
The data highlights statistically significant improvements in key genes responsible for fat production and fat metabolism, positioning GDNF as a potentially differentiated therapeutic approach targeting the root cause of fatty liver disease and metabolic dysfunction.Statistically significant reduction in Srebf1, a key gene driving fat production in the liverIncreased expression of Ppara, a central regulator of fat metabolism and fat burningGDNF outperformed semaglutide in key gene expression markers tied to liver fat regulationDemonstrated broad metabolic impact at the genetic level, not just weight reductionUnlike existing therapies that primarily focus on weight loss, GDNF directly targets the biological mechanisms responsible for fat accumulation in the liver.Srebf1 reduction ? less fat being createdPpara activation ? more fat being burnedNet effect ? reprogramming of liver metabolismThis dual mechanism suggests GDNF may offer a disease-modifying approach for MAFLD, obesity, and related metabolic disorders."HT-VA represents a major milestone for Hoth as we expand into high-value metabolic indications," said Robb Knie, Chief Executive Officer of Hoth Therapeutics."These results demonstrate that GDNF is not simply reducing fat, but fundamentally reprogramming how the body produces and metabolizes fat at the genetic level. The ability to shut down fat creation while activating fat metabolism differentiates GDNF from existing therapies, including GLP-1 agonists."SCIENTIFIC SUMMARY (HT-VA STUDY)The HT-VA study evaluated the effects of parenteral GDNF in a diet-induced obesity and MAFLD model.Key observations include:Western diet significantly increased liver fat accumulation and metabolic dysfunctionGDNF treatment significantly improved liver gene expression linked to fat metabolismReduced lipogenesis signaling (Srebf1) and enhanced metabolic regulation pathways (Ppara)Gene expression changes support improved hepatic lipid handling and metabolic efficiencySTRATEGIC IMPLICATIONSEntry into MAFLD/NASH and obesity markets Differentiation vs. GLP-1 therapies through gene-level mechanismPotential for first-in-class metabolic reprogramming therapyExpansion beyond Hoth's core dermatology and oncology pipelineNEXT STEPSHoth plans to:Advance HT-VA findings into additional preclinical validation studiesEvaluate clinical development pathways for metabolic and liver diseasesExplore strategic partnerships and collaborations to accelerate developmentAbout 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 StatementThis 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-hoth-reports-positive-ht-va-crada-data-gdnf-reprograms-liver-fat-metabolism-shuts-down-fat-creation-gene-and-activates-fat-burning-pathways-outperforming-semaglutide-302740965.htmlSOURCE Hoth Therapeutics, Inc.
Original: Hoth Therapeutics (HOTH) Reports Positive HT-VA CRADA Data: GDNF Reprograms Liver Fat Metabolism, Shuts Down Fat-Creation Gene and Activates Fat-Burning Pathways, Outperforming Semaglutide
US Market News
3月前
Hoth Therapeutics Announces Closing of $2.0 Million Registered Direct OfferingApril 2, 2026 4:05 PM
PR Newswire (US)
NEW YORK, April 2, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (Nasdaq: HOTH), a clinical-stage biopharmaceutical company focused on developing innovative therapies for unmet medical needs, today announced the closing of its previously announced registered direct offering for the purchase and sale of an aggregate of 2,857,144 shares of its common stock (or common stock equivalents in lieu thereof) at an offering price of $0.70 per share of common stock (or per common stock equivalent in lieu thereof). Additionally, in a concurrent private placement, the Company issued and sold unregistered warrants to purchase up to an aggregate of 2,857,144 shares of common stock at an exercise price of $0.85 per share. The unregistered warrants will become exercisable six months following the date of issuance and will expire five and one-half years following the date of issuance.
H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.The gross proceeds to the Company from the offering were approximately $2.0 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes, including working capital.The shares of common stock (or common stock equivalents in lieu thereof) described above (but not the unregistered warrants issued in the concurrent private placement and the shares issuable thereunder) were offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-291566) that was originally filed with the Securities and Exchange Commission (the "SEC") on November 17, 2015, and became effective on December 4, 2025. The offering of the shares of common stock (or common stock equivalents in lieu thereof) in the registered direct offering was made only by means of a base prospectus and prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering have been filed with the SEC and are available on the SEC's website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.The unregistered warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and/or Regulation D promulgated thereunder, have not been registered under the Act or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.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 StatementThis 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 relate to the use of proceeds from the offering and the potential exercise of the unregistered warrants prior to their expiration; 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 and other 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-announces-closing-of-2-0-million-registered-direct-offering-302733218.htmlSOURCE Hoth Therapeutics, Inc.
Original: Hoth Therapeutics Announces Closing of $2.0 Million Registered Direct Offering
US Market News
3月前
Hoth Therapeutics Announces $2.0 Million Registered Direct OfferingApril 1, 2026 1:52 PM
PR Newswire (US)
NEW YORK, April 1, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (Nasdaq: HOTH), a clinical-stage biopharmaceutical company focused on developing innovative therapies for unmet medical needs, today announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 2,857,144 shares of its common stock (or common stock equivalents in lieu thereof) at an offering price of $0.70 per share of common stock (or per common stock equivalent in lieu thereof), in a registered direct offering. Additionally, in a concurrent private placement, the Company issued and sold unregistered warrants to purchase up to an aggregate of 2,857,144 shares of common stock at an exercise price of $0.85 per share. The unregistered warrants will become exercisable six months following the date of issuance and will expire five and one-half years following the date of issuance. The closing of the offering is expected to occur on or about April 2, 2026, subject to the satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.The aggregate gross proceeds to the Company from the offering are expected to be approximately $2.0 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the unregistered warrants, if fully exercised on a cash basis, will be approximately $2.4 million. No assurance can be given that any of such unregistered warrants will be exercised. The Company intends to use the net proceeds from this offering for general corporate purposes, including working capital.The shares of common stock (or common stock equivalents in lieu thereof) described above (but not the unregistered warrants issued in the concurrent private placement and the shares issuable thereunder) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-291566) that was originally filed with the Securities and Exchange Commission (the "SEC") on November 17, 2015, and became effective on December 4, 2025. The offering of the shares of common stock (or common stock equivalents in lieu thereof) in the registered direct offering is being made only by means of a base prospectus and prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus, when available, may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.The unregistered warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and/or Regulation D promulgated thereunder, have not been registered under the Act or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.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 StatementThese statements relate to the consummation of the offering, the satisfaction of customary closing conditions related to the offering and the use of proceeds therefromThis 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 relate to the consummation of the offering; the satisfaction of customary closing conditions related to the offering; the use of proceeds from the offering and the potential exercise of the unregistered warrants prior to their expiration; 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 and other 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-announces-2-0-million-registered-direct-offering-302731790.htmlSOURCE Hoth Therapeutics, Inc.
Original: Hoth Therapeutics Announces $2.0 Million Registered Direct Offering
US Market News
3月前
Hungary Approves Trial Expansion as HT-001 Meets Primary Endpoint in Interim Analysis with Patients Reaching ARIGA ≤1 by Week SixApril 1, 2026 8:14 AM
PR Newswire (US)
Over 65% of Patients Reported Reduced Pain and Itching; Zero Disruptions to EGFR Cancer Therapy with ~99% Lower Systemic ExposureNEW YORK, April 1, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, today announced positive clinical results from its ongoing HT-001 program, including achievement of the primary efficacy endpoint in interim analysis, with patients reaching an ARIGA rash severity score of ≤1 by week six.
In addition to the strong results in Ariga score, HT-001 demonstrated strong patient benefit across multiple clinically meaningful measures. Over 65% of patients reported meaningful reductions in pain and itching, supporting HT-001's potential to significantly improve quality of life for patients suffering from dermatologic toxicities, including those associated with epidermal growth factor receptor inhibitor (EGFR) cancer therapies.Importantly, zero patients required dose reduction or discontinuation of their EGFR inhibitor therapy while receiving HT-001, highlighting the potential for HT-001 to manage dermatologic side effects without interfering with life-saving cancer treatments.HT-001 was also well tolerated, with no treatment discontinuations reported.Pharmacokinetic (PK) analysis further demonstrated that HT-001 achieves approximately 99% lower systemic exposure compared to FDA-approved oral therapies, supporting a targeted delivery profile designed to maximize local efficacy while minimizing systemic side effects.Building on these positive results, Hoth has received regulatory approval in Hungary, enabling expansion of the Phase 2 clinical trial into Europe. The Company anticipates additional regulatory approvals in Spain and Poland, with site activations expected in the near term. In the United States, an additional clinical site is expected to be activated, further accelerating patient enrollment and data generation."The achievement of these interim results, combined with strong patient-reported outcomes and the ability to maintain uninterrupted cancer therapy, represents a meaningful advancement for HT-001," said Robb Knie Chief Executive Officer of Hoth Therapeutics. "With over 65% of patients reporting reductions in pain and itching, along with a favorable safety profile and expanding global clinical footprint, we believe HT-001 is well positioned as a differentiated therapy addressing a critical unmet need in oncology supportive care."Dermatologic toxicities remain a significant challenge for patients undergoing cancer treatment, often leading to discomfort, reduced quality of life, and in some cases treatment modification or discontinuation. HT-001's ability to demonstrate primary endpoint achievement, meaningful symptom improvement, and zero disruption to EGFR inhibitor therapy may represent a compelling advancement over existing treatment options.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/hungary-approves-trial-expansion-as-ht-001-meets-primary-endpoint-in-interim-analysis-with-patients-reaching-ariga-1-by-week-six-302731156.htmlSOURCE Hoth Therapeutics, Inc.
Original: Hungary Approves Trial Expansion as HT-001 Meets Primary Endpoint in Interim Analysis with Patients Reaching ARIGA ≤1 by Week Six
US Market News
3月前
Hoth Therapeutics Announces Issuance of Chinese Patent for Cancer Cell-Targeting TechnologyMarch 31, 2026 8:07 AM
PR Newswire (US)
Technology Selectively Shuts Down Cancer Reproducing CellsPatent Covers Splice-Switching Oligonucleotide Platform Designed to Induce Apoptosis of Mast CellsNEW YORK, March 31, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing innovative therapies for unmet medical needs, today announced that the China National Intellectual Property Administration (CNIPA) has granted Chinese Patent, titled "Targeting Kit with Splice Switching Oligonucleotides to Induce Apoptosis of Mast Cells."
The patent, originally filed under PCT Application No. PCT/US2019/048400 and developed by North Carolina State University, strengthens Hoth's intellectual property portfolio and provides protection in a key global market through August 27, 2039, subject to maintenance requirements.The granted patent relates to a novel therapeutic platform utilizing splice-switching oligonucleotides designed to selectively induce apoptosis in mast cells, which play a central role in a variety of inflammatory and immunological conditions."This patent grant in China represents an important milestone in expanding our global intellectual property protection for this innovative platform," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "We believe this technology has broad potential across multiple indications where mast cell activity contributes to disease, and this issuance further strengthens our position as we advance development."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-announces-issuance-of-chinese-patent-for-cancer-celltargeting-technology-302729593.htmlSOURCE Hoth Therapeutics, Inc.
Original: Hoth Therapeutics Announces Issuance of Chinese Patent for Cancer Cell-Targeting Technology
US Market News
3月前
Hoth Therapeutics Deploys OpenClaw™ AI Platform to Accelerate Drug DiscoveryMarch 26, 2026 8:30 AM
PR Newswire (US)
NEW YORK, March 26, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, today announced the deployment of OpenClaw™, an advanced AI-enabled computational platform designed to accelerate drug discovery, enhance data-driven decision-making, and unlock value across its therapeutic pipeline.
OpenClaw™ Activation Marks Strategic Shift Toward AI-Driven Drug DevelopmentThe launch of OpenClaw™ establishes a centralized, high-performance platform capable of integrating preclinical and clinical datasets in real time, enabling faster and more efficient research execution.Platform Designed to Accelerate Timelines and Increase Probability of SuccessOpenClaw™ enables rapid analysis of complex biological data, supporting smarter candidate selection and prioritization. The platform is expected to enhance development efficiency and improve the probability of technical success across Hoth's programs.Eliminating Data Silos While Scaling Across Multiple IndicationsThe system's modular design allows seamless deployment across dermatology, oncology, and inflammatory disease programs, standardizing workflows and increasing reproducibility at scale.AI + Infrastructure Strategy Positions Hoth for Next Phase of GrowthWith the deployment of OpenClaw™, Hoth strengthens its positioning at the intersection of biotechnology and artificial intelligence—leveraging advanced analytics to drive innovation and pipeline expansion."We are entering a new phase of execution at Hoth," said Robb Knie, Chief Executive Officer. "OpenClaw™ enhances our ability to move faster, make better decisions, and extract more value from our data—positioning us to accelerate."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-deploys-openclaw-ai-platform-to-accelerate-drug-discovery-302725506.htmlSOURCE Hoth Therapeutics, Inc.
Original: Hoth Therapeutics Deploys OpenClaw™ AI Platform to Accelerate Drug Discovery
US Market News
3月前
Hoth Therapeutics Reports Positive HT-001 PK, Safety, and Clinical Activity Data in Cancer Patients with EGFR Therapy-Associated Skin Toxicities Showing ~77% Increase in Drug Exposure and Minimal Systemic AbsorptionMarch 24, 2026 8:13 AM
PR Newswire (US)
PK studies of topical HT-001 reveal limited systemic absorption and ~99% reduced systemic levels as compared to FDA approved oral formulations.Safety and tolerability findings included:No serious adverse events (0%)No dose-limiting toxicities observed.No treatment discontinuations due to adverse eventsDay 42 Data Show Higher AUC, Cavg, and Cmax vs Day 1, with ~2.1x Accumulation Supporting Sustained Drug Exposure, Consistent Tolerability, and Clinically Meaningful ResponseNEW YORK, March 24, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH) today reported positive pharmacokinetic (PK), safety, and clinical activity data for HT-001, demonstrating a ~77% increase in systemic drug exposure following repeat dosing, minimal systemic absorption relative to oral formulations, a favorable safety profile with no serious adverse events, and encouraging reductions in symptom severity.
In addition, HT-001 demonstrated encouraging clinical activity, with treated subjects exhibiting meaningful reductions in symptom severity and sustained response over the treatment period. These efficacy observations were consistent with the pharmacokinetic profile, suggesting that increased and sustained drug exposure may translate into improved clinical outcomes.In the Company's PK analysis, mean AUC0–24 increased to 80.60 h•ng/mL on Day 42 from 45.61 h•ng/mL on Day 1, representing an approximate 76.7% increase in systemic exposure. Mean Cavg increased to 3.36 ng/mL from 1.90 ng/mL (~76.8%), while mean Cmax increased to 4.56 ng/mL from 3.07 ng/mL (~48.5%), demonstrating consistent, dose-dependent increases in drug exposure.Mean and individual concentration-time profiles showed higher overall exposure at Day 42 compared to Day 1. Semilog analysis confirmed predictable elimination kinetics and sustained plasma concentrations across the dosing interval.Importantly, systemic exposure following topical HT-001 remained minimal relative to oral formulations. On Day 1, exposure levels were approximately 0.2% of those observed with FDA-approved oral formulations, and remained below 0.5% on Day 42 despite repeated dosing.Systemic absorption was observed in a subset of subjects, consistent with topical delivery, and remained low overall, supporting a favorable systemic safety profile.Across paired evaluable subjects, the mean accumulation ratio (RA_AUCt) was approximately 2.09x, with mean RA_Cmax of approximately 1.72x, supporting repeat-dose pharmacokinetic activity and sustained drug levels over time.Safety and tolerability findings included:No serious adverse events (0%)No dose-limiting toxicities observedNo treatment discontinuations due to adverse events"These pharmacokinetic results, combined with a favorable safety and tolerability profile, support the continued advancement of HT-001," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "The approximately 77% increase in systemic exposure, along with consistent accumulation and minimal systemic absorption relative to oral therapies, reinforces our dosing strategy as we advance development."The Company believes these data support continued clinical advancement and dose optimization, with PK findings aligning with observed clinical outcomes, including meaningful reductions in symptom severity and sustained patient response.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-reports-positive-ht-001-pk-safety-and-clinical-activity-data-in-cancer-patients-with-egfr-therapyassociated-skin-toxicities-showing-77-increase-in-drug-exposure-and-minimal-systemic-absorption-302722341.htmlSOURCE Hoth Therapeutics, Inc.
Original: Hoth Therapeutics Reports Positive HT-001 PK, Safety, and Clinical Activity Data in Cancer Patients with EGFR Therapy-Associated Skin Toxicities Showing ~77% Increase in Drug Exposure and Minimal Systemic Absorption
US Market News
3月前
Hoth Therapeutics Reports Positive Female Preclinical Data Showing HT-VA Restores Cholesterol Levels and Improves Lipid Metabolism in MASLD ModelMarch 10, 2026 8:13 AM
PR Newswire (US)
HT-VA restores cholesterol to control-diet levels and maintains lower triglycerides compared with semaglutide in western diet–fed female miceTreatment preserved hepatic autophagy and maintained normal liver cellular homeostasisFindings support continued development of HT-VA for metabolic dysfunction associated with obesity and MASLDNEW YORK, March 10, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with unmet medical needs, today announced new female-specific preclinical results from the second phase of its metabolic disease study evaluating glial cell-derived neurotrophic factor (GDNF).
The second phase of the study evaluated serum liver biochemistry and hepatic molecular pathways in female mice fed a western diet to model metabolic dysfunction associated with obesity and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).Results demonstrate that GDNF improved lipid metabolism biomarkers and preserved key cellular pathways in the liver compared with western diet controls and the GLP-1 agonist Semaglutide.GDNF Restores Elevated Cholesterol Levels to Control-Diet Range in Western Diet–Fed Female MiceFemale mice fed a western diet demonstrated increased serum cholesterol levels relative to control diet animals.Treatment with GDNF restored cholesterol concentrations to levels comparable with control diet-fed mice, indicating improved lipid metabolism in the diet-induced metabolic dysfunction model.GDNF Maintains Lower Triglyceride Levels While Semaglutide Increases Triglycerides in Female MiceFemale mice treated with Semaglutide while on a western diet showed increased serum triglyceride levels.In contrast, GDNF-treated western diet mice maintained lower triglyceride levels, demonstrating a more favorable lipid profile in this study.Albumin and Alkaline Phosphatase Remain Stable Across Female Treatment GroupsAnalysis of liver biochemistry markers demonstrated:No change in albumin (ALB) levels across diets or treatmentsNo significant change in alkaline phosphatase (ALP)These findings indicate liver synthetic function remained stable across female treatment groups.GDNF Preserves Hepatic Autophagy While Semaglutide Increases p62 AccumulationEvaluation of liver autophagy markers revealed:Semaglutide increased p62/SQSTM1 levels in western diet-fed female miceGDNF treatment did not increase p62 expressionAccumulation of p62 is associated with impaired autophagic degradation, suggesting GDNF preserved normal cellular recycling pathways in the liver.No Activation of Lipid Uptake or Lipogenesis Pathways Observed in Female Mice Treated with GDNFProtein expression analysis showed:No change in PPAR? expressionNo change in CD36 expressionThese proteins are associated with hepatic lipid uptake and fat accumulation, indicating that GDNF improved metabolic biomarkers without activating lipogenic pathways.Semaglutide Increases Hepatic AKT Signaling While GDNF Shows No ChangeWestern diet-fed female mice treated with Semaglutide demonstrated increased phosphorylation of AKT (pAKT) in liver tissue.By contrast, GDNF treatment did not significantly alter pAKT signaling, highlighting a distinct molecular signaling profile.Study OverviewThe second phase of the preclinical study focused on evaluating liver metabolism and molecular signaling pathways in female mice.Study design included:Female mice fed control diet or western diet for eight weeksFour weeks of treatment with GDNF, semaglutide, or vehicleEvaluation of serum liver biochemistry and hepatic protein expression related to lipid metabolism, autophagy, and apoptosisEach treatment group included 8–10 animals, with results reported as mean ± SEM.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-reports-positive-female-preclinical-data-showing-ht-va-restores-cholesterol-levels-and-improves-lipid-metabolism-in-masld-model-302708703.htmlSOURCE Hoth Therapeutics, Inc.
Original: Hoth Therapeutics Reports Positive Female Preclinical Data Showing HT-VA Restores Cholesterol Levels and Improves Lipid Metabolism in MASLD Model
US Market News
4月前
Hoth Therapeutics Deploys OpenAI API to Advance Development of Orphan HT-KIT Oncology ProgramMarch 4, 2026 8:31 AM
PR Newswire (US)
AI Integration Supports IND Preparation & Phase 1 Progression for Rare KIT-Driven CancersNEW YORK, March 4, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company advancing breakthrough therapies for diseases, today announced the deployment of the OpenAI API to support IND-enabling development of HT-KIT, its orphan-designated therapy targeting rare and aggressive KIT-driven cancers.
The OpenAI-powered API platform has been integrated into the HT-KIT development workflow to support preclinical data analysis, molecular modeling of KIT-driven pathways, and preparation of regulatory documentation ahead of IND submission.HT-KIT results below have shown success in rare cancers Potent gene-level target suppression: HT-KIT achieved >80% reduction of KIT mRNA/protein across in-vitro systems and in vivo models of systemic mastocytosis and GIST.Favorable tolerability in early studies: No dose-limiting toxicities observed in the reported preclinical work to date.Rapid anti-tumor activity: In xenograft models, statistically significant tumor-volume reduction by Day 8 was observed, accompanied by apoptotic signaling consistent with KIT pathway knock-down.Bioanalytical readiness: GLP-validated bioanalytical methods completed to support pharmacokinetic, biodistribution, and exposure-response analyses for IND.HT-KIT is advancing toward Investigational New Drug (IND) submission and Phase 1 clinical evaluation.HT-KIT has received Orphan Drug Designation and is designed to address cancers driven by KIT mutations, an area of significant unmet medical need."Hoth's integration of OpenAI's API supports execution of our IND-enabling strategy for HT-KIT as we advance toward Phase 1," said Robb Knie, Chief Executive Officer.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 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-deploys-openai-api-to-advance-development-of-orphan-ht-kit-oncology-program-302702356.htmlSOURCE Hoth Therapeutics, Inc.
Original: Hoth Therapeutics Deploys OpenAI API to Advance Development of Orphan HT-KIT Oncology Program
US Market News
4月前
HOTH THERAPEUTICS ACCELERATES HT-001 TRIAL ENROLLMENT WITH NEW CLINICAL SITE AS PATIENT DEMAND INCREASESFebruary 24, 2026 4:15 PM
PR Newswire (US)
CLEER-001 Phase 2a Expansion Signals Growing Momentum Behind First-in-Class Therapy for Cancer Patients With No Current FDA-Approved Treatment OptionNEW 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 SignalThe 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 sixZero patients required dose reduction or discontinuation of their life-saving EGFRi cancer therapy while on HT-001Over 65% of patients reported meaningful reductions in pain and itchingZero dose-limiting toxicities observed across the entire trial to dateAt 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 patientFor 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 NetworkRegis 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 StatementThis 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.htmlSOURCE Hoth Therapeutics, Inc.
Original: HOTH THERAPEUTICS ACCELERATES HT-001 TRIAL ENROLLMENT WITH NEW CLINICAL SITE AS PATIENT DEMAND INCREASES
US Market News
4月前
Hoth Therapeutics Receives U.S. Notice of Allowance for Novel Exon-Skipping Therapy Targeting Allergic DiseasesFebruary 12, 2026 8:33 AM
PR Newswire (US)
Patent Covers Combination of FC Epsilon RI-Beta Exon Skipping and MS4A6A Modulation — Strengthening Hoth's Immunology IP PortfolioNEW YORK, Feb. 12, 2026 /PRNewswire-PRWeb/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company advancing breakthrough therapies for diseases, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for "Exon Skipping of FC-Epsilon-RI-Beta and MS4A6A in the Treatment of Allergic Diseases."
The Notice of Allowance confirms that the USPTO has allowed all pending claims in the application, moving the patent toward formal issuance.This patent protects a novel dual-mechanism approach targeting key regulators of allergic and inflammatory responses, positioning Hoth at the forefront of next-generation immunomodulatory therapies.Strategic ImportanceThe allowed claims cover methods directed at:Exon skipping a critical component of the high-affinity IgE receptor pathway central to allergic disease activationModulation of MS4A6A, a gene associated with immune signaling and inflammatory regulationCombination therapeutic strategies designed to reduce hypersensitivity responses at a molecular levelBy targeting upstream drivers of allergic inflammation rather than solely treating downstream symptoms, this approach represents a differentiated strategy in a global allergy and immunology market. Management CommentaryRobb Knie, Chief Executive Officer of Hoth Therapeutics, stated:"Receiving this Notice of Allowance marks another important milestone in building Hoth's intellectual property portfolio. This novel exon-skipping platform further expands our strategy of developing differentiated, mechanistically targeted therapies for immune-driven diseases. We believe this patent strengthens our competitive positioning and enhances long-term shareholder value."Intellectual Property MomentumWith this Notice of Allowance, Hoth continues to:Expand its proprietary immunology platformBuild layered patent protection around novel therapeutic mechanismsStrengthen potential partnership and licensing discussionsIncrease long-term defensibility in allergic and inflammatory disease marketsAbout 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-receives-us-notice-of-allowance-for-novel-exon-skipping-therapy-targeting-allergic-diseases-302686267.htmlSOURCE Hoth Therapeutics, Inc.
Original: Hoth Therapeutics Receives U.S. Notice of Allowance for Novel Exon-Skipping Therapy Targeting Allergic Diseases
US Market News
4月前
Hoth Therapeutics Announces Groundbreaking Positive Results: Hoth's HT-VA GDNF Surpasses Semaglutide in Weight Loss, Glucose Control, and Liver Health in Obesity ModelFebruary 10, 2026 8:30 AM
PR Newswire (US)
In a head-to-head preclinical comparison, HT-VA co-developed with the United States Veterans Administration GDNF demonstrated superior efficacy compared with semaglutide (the active ingredient in Wegovy®️ and Ozempic®️) across key metrics, including weight stabilization, glucose tolerance, liver weight reduction, and adipose tissue control—particularly in female modelsNEW YORK, Feb. 10, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company developing innovative therapies for unmet medical needs, today announced compelling preclinical data from its VA-backed study on glial cell-derived neurotrophic factor (GDNF) as a novel treatment for obesity and metabolic-associated steatotic liver disease (MASLD). In a head-to-head comparison, GDNF demonstrated superior efficacy over semaglutide (the active ingredient in Wegovy® and Ozempic®) in key metrics, including weight stabilization, glucose tolerance, liver weight reduction, and adipose tissue control—particularly in female models.
This breakthrough positions GDNF as a potential gamechanger in the $200 billion obesity market, offering a differentiated mechanism that could address limitations of current GLP-1 agonists like gastrointestinal side effects and muscle loss. With obesity affecting over 1 billion people globally and MASLD impacting up to 30% of adults, GDNF's multi-faceted benefits could revolutionize treatment paradigms.Key Study Highlights:Superior Weight Management: In female mice on a high-fat Western diet, GDNF attenuated weight gain by 10-15%, leading to a plateau in the final weeks of treatment—unlike semaglutide, which showed no significant impact. Researchers noted that higher doses or longer durations could amplify GDNF's effects, suggesting even greater potential for sustained weight loss.Enhanced Glucose Metabolism: GDNF fully normalized fasting glucose and improved overall response to glucose challenges, outperforming semaglutide in females. Baseline improvements were also seen in males, indicating broad metabolic benefits.Liver and Adipose Health: GDNF reduced liver weight by 20-30% and prevented adipose tissue accumulation in females, surpassing semaglutide's effects. This underscores GDNF's promise in resolving fatty liver disease, a common complication of obesity.Study Design: Conducted at the Srinivasan Lab with VA support, the 12-week study used CF-1 mice to model human obesity. GDNF was administered subcutaneously with escalating doses (2-12 µg/mouse), compared to semaglutide (12 ng/g/mouse)."These results are a monumental step forward for Hoth and the fight against obesity," said Robb Knie, CEO of Hoth Therapeutics. "GDNF not only matched but exceeded semaglutide in critical areas, opening doors to a new era of safer, more effective therapies. As we advance this program, we're excited about its potential to deliver life-changing outcomes for patients and significant value for our shareholders."The study builds on prior research showing GDNF's protective role against diet-induced obesity. Future analyses will include liver pathology, lipid content, and gene/protein expression to further elucidate mechanisms. Hoth plans to accelerate GDNF toward IND-enabling studies, targeting clinical trials in 2027.Hoth's GDNF program is part of a robust pipeline, including HT-001 (Phase 2 for cancer-related skin toxicities), HT-KIT (Orphan Drug Designation for mast cell cancers), and HT-ALZ (for Alzheimer's).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-announces-groundbreaking-positive-results-hoths-ht-va-gdnf-surpasses-semaglutide-in-weight-loss-glucose-control-and-liver-health-in-obesity-model-302682954.htmlSOURCE Hoth Therapeutics, Inc.
Original: Hoth Therapeutics Announces Groundbreaking Positive Results: Hoth's HT-VA GDNF Surpasses Semaglutide in Weight Loss, Glucose Control, and Liver Health in Obesity Model
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