Overview

Immuno Therapeutics Inc. is a pre-revenue, development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders. The company’s pipeline is centered around two main programs: a Na v 1.7 modulation program to treat chronic and acute pain disorders, and a combination antiviral therapy program targeting reactivated herpes virus mediated illnesses.

Na v 1.7 Non-Opioid Analgesic Program

Immuno Therapeutics’ lead product candidate is Halneuron®, which is in Phase 2 clinical development for the treatment of chemotherapy-induced neuropathic pain (CINP). Halneuron® works by modulating the activity of the Na v 1.7 sodium channel, which is involved in pain signal transmission. The company commenced dosing patients in the HALT-CINP-203 clinical trial in the first quarter of 2025 to evaluate the efficacy and safety of Halneuron® in 200 patients with moderate to severe CINP. Top-line data from this trial are expected in the second half of 2026.

Antiviral Program

Immuno Therapeutics is also developing IMC-1 and IMC-2, which are novel, proprietary, fixed-dose combinations of nucleoside analog anti-herpes antivirals and the anti-inflammatory agent celecoxib. These combinations are intended to synergistically suppress herpesvirus activation and replication, with the goal of reducing a patient’s viral-mediated disease burden.

Financial Performance

In the first quarter of 2025, Immuno Therapeutics reported a net loss of $10.9 million, compared to a net loss of $1.3 million in the same period of 2024. The increase in net loss was primarily due to higher research and development expenses of $2.1 million, driven by the HALT-CINP-203 clinical trial, as well as a $1.0 million increase in general and administrative expenses related to the company’s combination transaction and becoming a public company.

As of March 31, 2025, Immuno Therapeutics had $17.5 million in cash, which the company believes will fund operations through the first quarter of 2026. However, the company will need to secure additional financing to fund its ongoing clinical trials and operations beyond that point to continue executing its strategy.

Strengths and Weaknesses

Immuno Therapeutics’ key strengths include its focus on novel, non-opioid pain management and antiviral therapies, as well as the progress it has made in advancing its lead product candidate, Halneuron®, into Phase 2 clinical trials. The company’s reliance on external financing and the lack of revenue from product sales are potential weaknesses.

Outlook

The company’s ability to successfully develop and commercialize its product candidates, as well as its capacity to secure additional financing, will be critical to its future outlook. The results of the HALT-CINP-203 trial for Halneuron® will be a key milestone in 2026, and the company’s progress in its antiviral program will also be an important factor to watch. Overall, Immuno Therapeutics faces both opportunities and challenges as it works to advance its pipeline and achieve its goal of becoming a commercial-stage biopharmaceutical company.