Positive interim findings drive early trial conclusion; Hoth prepares to seek FDA alignment on a potential pivotal study for cancer treatment-related skin toxicity
HOBOKEN, N.J., Nov. 3, 2026 /PRNewswire/ -- Rocket One Inc. (Nasdaq: RKTO) ("Rocket One" or the "Company") today announced that its biotechnology subsidiary, Hoth Therapeutics, has decided to end its Phase 2a clinical trial of HT-001 early following strong interim efficacy results. Hoth is preparing to seek U.S. Food and Drug Administration (FDA) feedback on advancing HT-001 into a potential Phase 3 clinical program.
HT-001 is an investigational topical formulation of aprepitant being developed to treat dermatologic toxicities associated with epidermal growth factor receptor (EGFR) inhibitor cancer therapies. These skin complications can cause significant discomfort, affect patients' quality of life, and lead to interruptions or modifications of cancer treatment.
Following review of the available interim efficacy and safety data, Hoth determined that the findings support concluding Phase 2a early and pursuing regulatory discussions on the next stage of development.
"We are encouraged by the strength of the interim findings and believe they support taking the next step toward a potential Phase 3 program," said Robb Knie, Chief Executive Officer of Rocket One. "Our goal is to help patients manage the skin toxicity associated with EGFR inhibitor therapy so they can better tolerate their cancer treatment. We are now focused on presenting the data to the FDA and establishing the requirements for the next stage of HT-001's development."
Interim Findings Support Decision to Conclude Phase 2a Early
Hoth's decision reflects its assessment of the clinical activity observed in the interim analysis and the information needed to guide further development.
The Company plans to complete the remaining data review and analysis necessary to support its regulatory submission and proposed development strategy. Interim results are preliminary and may change as additional data are collected and finalized.
Preparing for a Potential Phase 3 Program
Hoth intends to request FDA feedback on the proposed pathway for HT-001, including the design of a potential pivotal study, selection of efficacy endpoints, patient population, statistical considerations, safety requirements, and manufacturing readiness.
Initiation of a Phase 3 trial will depend on regulatory feedback, completion of required development activities.
"Moving toward a potential pivotal program is a meaningful development objective for Hoth," Knie added. "We believe these findings warrant a focused discussion with the FDA about how to evaluate HT-001 in a larger study and generate the evidence needed to support a potential registration pathway."
Addressing Skin Toxicity During Cancer Treatment
EGFR inhibitors are used to treat several types of cancer. Their associated dermatologic toxicities, including rash and related symptoms, can create a substantial burden for patients and complicate treatment management.
HT-001 is designed to deliver aprepitant, a neurokinin-1 receptor antagonist, directly to affected skin. Its development program is evaluating whether this topical approach can provide clinically meaningful improvements in EGFR inhibitor-associated skin toxicity with an acceptable safety profile.
HT-001 remains investigational and has not been approved by the FDA for any indication.
About HT-001
HT-001 is an investigational topical formulation of aprepitant under development for dermatologic toxicities associated with EGFR inhibitor cancer therapies. Its clinical program is evaluating efficacy, safety, and tolerability in this oncology supportive-care setting.
About Hoth Therapeutics
Hoth Therapeutics, a biotechnology subsidiary of Rocket One, is advancing investigational therapeutic programs, including HT-001, with the goal of addressing unmet patient needs.
About Rocket One Inc.
Rocket One Inc. is a publicly traded technology company building a portfolio across artificial intelligence infrastructure, advanced semiconductor technologies, space and defense systems, and autonomous platforms. Rocket One is advancing licensed spintronic and nanomagnetic computing technologies for AI acceleration and radiation-tolerant computing, together with Swarm Stage AI, a drone-swarm threat-emulation and counter-UAS training platform. Tracer Drone Technologies, LLC (a Rocket One company) provides end-to-end drone solutions including hardware, software, FAA training, and technical support to help public safety, commercial, and enterprise organizations successfully deploy and maintain their aerial programs.
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.
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