HOTH.O News & Events

Hoth Therapeutics announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 2.86M shares of its common stock at an offering price of 70c per share of common stock, 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 2.86M shares of common stock at an exercise price of 85c 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, subject to the satisfaction of customary closing conditions. The aggregate gross proceeds to the company from the offering are expected to be approximately $2M, 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 $2.4M. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

Hoth Therapeutics 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 less than or equal to1 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 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 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.

Hoth Therapeutics announced that the China National Intellectual Property Administration 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.

Hoth Therapeutics reported "positive" pharmacokinetic - or 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 AUC-2 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 76.8%, while mean Cmax increased 48.5% demonstrating consistent, dose-dependent increases in drug exposure. Systemic absorption was observed in a subset of subjects, consistent with topical delivery, and remained low overall, supporting a favorable systemic safety profile. No serious adverse events, no dose-limiting toxicities observed, and no treatment discontinuations due to adverse events. The company believes these data support continued clinical advancement and dose optimization.