EOM Pharmaceutical Holdings Reports Promising Preclinical Results and Provides an Update on EOM613 and EOM147

Clinical Trials in Cancer Cachexia, Inflammatory Bowel Disease and Retinal Disorders are Planned

MONTVALE, N. J., Jan. 07, 2026 (GLOBE NEWSWIRE) -- EOM Pharmaceutical Holdings, Inc. (OTC: IMUC) (“EOM”) an innovative biotechnology company focused on developing transformative treatments for chronic inflammatory conditions and debilitating retinal diseases, today provides an update on its preclinical programs in 2025 and its planned clinical activities in 2026 for its two lead product candidates EOM613 and EOM147.

In 2025, the company completed IND-enabling toxicological and dosing preclinical animal studies for EOM613 with favorable results. No adverse drug-related toxic effects were seen with daily subcutaneous injections of EOM613 for 28 consecutive days, including at 13.5 times the highest anticipated dosing levels in humans, indicating a wide margin of tolerability. In addition, no adverse effects were seen in tissue upon histopathological testing. Based on these data, combined with previously reported promising results of our Phase I/IIa 2023 human clinical trial in hospitalized COVID-19 patients with cytokine-driven respiratory inflammation in Brazil, we are planning an initial Phase II exploratory clinical trial in patients with Crohn’s disease.

This trial is designed to include 15-20 patients and will be conducted at clinical sites in New Brunswick and Lakewood, NJ, under Principal Investigator Arkady Broder, MD, Director of Gastroenterology at the St. Peter’s Healthcare System. The trial will enroll subjects with moderate to severe Crohn’s disease who have failed or could not tolerate at least one conventional therapy. EOM anticipates initiating the trial in the first quarter 2026 to test for signs of clinical remission and endoscopic remission with EOM613 treatment and to measure biomarkers such as C-reactive protein, calprotectin and pro-inflammatory serum cytokines.

In addition, based on these preclinical results, EOM plans to reactivate an Investigational New Drug (IND) application for the treatment of cachectic cancer patients at the FDA’s Office of Oncologic Diseases (OOD) with a view to conducting an open-label Phase II trial with Stage 4 cancer patients. The trial’s Principal Investigator is Azriel Hirschfeld, MD, at Hirschfeld Oncology in Brooklyn, NY, an expert in the treatment of gastrointestinal cancer patients with advanced disease who typically progress to a cachectic condition. The enrolled patients will be treated with EOM613 on a daily basis for 26 weeks. There is currently no approved drug for the treatment of cancer cachexia in the United States.

“EOM has designed a clinical program for Crohn’s disease patients who have failed currently available therapies or are unable to tolerate them,” stated Shalom Z. Hirschman, MD, Chief Medical Officer of EOM. “In previous clinical trials in AIDS, cancer cachexia and COVID-19 patients, EOM613 treatment was well-tolerated, even in very sick patients. A broad-spectrum immune regulating agent that regulates pro-and anti-inflammatory cytokines in patients without the risk of severe side effects associated with the use of antibody or corticosteroid drugs could be beneficial in the treatment of Crohn’s disease and ulcerative colitis. We are also pleased to advance the potential use of EOM613 in cancer cachexia patients given the promising results in its exploratory trial in Canada.”

About EOM613

EOM’s lead asset, EOM613 is a peptide-nucleic acid-based broad spectrum immune regulating agent that acts on both key pro-inflammatory and anti-inflammatory cytokines with potential therapeutic utility in treating a variety of acute and chronic inflammatory conditions. This agent has been previously shown to regulate cytokine expression in a variety of immune cells in cell culture, and had been previously found beneficial in open-label clinical trials in rheumatoid arthritis. EOM613 had also previously shown beneficial effects in stabilizing the weight and improving the functional status of patients with advanced malignancies who also had cancer cachexia (the debilitating condition of muscle wasting, fatigue and weight loss) in Stage III and Stage IV cancer, the pathophysiology of which is largely driven by pro-inflammatory cytokines.

This clinical finding may be of particular interest since the pathophysiology of inflammatory bowel disease (IBD) is known to be largely driven by the release of inflammatory cytokines in the gastrointestinal tract, in particular TNF-alpha, interleukin 12 (IL-12), interleukin-23 (IL-23) and sIL-2R. In light of the Brazilian clinical trial results, the company is currently preparing to initiate an EOM613 clinical program in Crohn’s disease.

Potential of EOM147 in Retinal Diseases

EOM147 is a first-in-class small molecule anti-angiogenic drug with a novel intracellular mechanism of action for the treatment of proliferative diabetic retinopathy, diabetic macular edema, branch and central retinal vein occlusions, and wet age-related macular degeneration (AMD). EOM147 is being developed as a proprietary, newly reformulated eye drop containing a steroid-polyamine conjugate small molecule with anti-angiogenic activity, which targets multiple angiogenic growth factors through a calmodulin-mediated mechanism. EOM147 represents a potential new approach as it does not require intraocular injection directly into the eye and could represent a topically administered eye drop to treat retinal diseases.

Novel chemically stable eye drop formulations have been developed for the EOM147 active pharmaceutical ingredient (API). The GMP manufacture of the API via a scalable synthesis route is currently being carried out at a contracted manufacturing site to support the required nonclinical animal studies of bioanalytical measurement of the drug in plasma, and ocular toxicity studies/ocular tissue drug uptake. These specialized nonclinical studies are anticipated to begin in the first quarter of 2026 in Quebec, Canada. If the results are favorable, EOM intends to conduct Phase I/II trials with the novel eye drop formulation of EOM147 in retinal vein occlusions (RVO) in the United States, and in diabetic retinopathy (DR) in Mexico and India.

EOM Chief Executive Officer Dr. Irach Taraporewala said: “Completing the development of these novel eyes drop formulations is an important step forward for the company. We believe our eye drop has the potential to become a new approach to the treatment of multiple angiogenic retinal diseases. If EOM147 demonstrates improvement in vision acuity, it has potential to become the first topical eye drop adjunct therapy to anti-vascular endothelial growth factor (anti-VEGF) injections, offering a patient-friendly formulation of daily, self-administered eye drops. This could replace the need for periodic intraocular injections into the eye administered by a retinal physician specialist to control and manage often blinding retinal disorders such as retinal vein occlusions, diabetic retinopathy and wet age-related macular degeneration (wet AMD).”

About EOM Pharmaceutical Holdings, Inc.

EOM Pharmaceutical Holdings, Inc. is a clinical-stage company focused on developing novel drugs with the potential to transform therapeutic paradigms and improve quality of life in patients suffering from debilitating and sometimes deadly diseases. The company was founded with a specific vision to pursue innovative approaches to rescue, repair, and restore health of patients with urgent and unmet medical needs. For more information about EOM Pharmaceuticals, please visit www.eompharma.com.

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. In some cases, you can identify these statements by forward-looking words such as "may," "will," "continue," "anticipate," "intend," "could," "project," "expect" or the negative or plural of these words or similar expressions, and other similar terms. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, EOM's ability to develop and commercialize its product candidates; EOM's ability to obtain and maintain regulatory approval of product candidates; EOM's ability to operate in a competitive industry and compete successfully against competitors that have greater resources; EOM's reliance on third parties; EOM's ability to obtain and adequately protect intellectual property rights for product candidates; and the effects of COVID-19 on clinical programs and EOM's business operations. Any forward-looking statements in this press release speak only as of the date of this press release. EOM assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Investor Contact:

Wayne I. Danson, Chief Financial Officer
info@eompharma.com