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,