The year 2025 was focused on science, advancing our programs.

1. We optimized MF5 our estrogen receptor beta (ERβ) selective agonist drug for the treatment of menopausal symptoms and the prevention of breast cancer.
2. We generated new drug candidates using AI for BZ2 our glycolysis inhibitor drug for the treatment of solid tumors and more specifically triple negative breast cancer.
3. We continued the optimization of MD1 our first in class nuclear receptor reprogramming drug for the treatment of menopausal metabolic syndrome and the prevention of Type 2 Diabetes in menopausal women.

Iaterion is continuing its focus on Women’s Health and diseases related to female biology. Our initial focus is on aging women’s issues.

The industry at large is facing difficult times. Changes proposed to the structure and funding of the NIH and the way in which the FDA reviews drugs brought uncertainty to the field. More so, global economic instability makes the funding environment challenging. This resulted in a 4.8% decline in the biotech workforce and a funding “cliff” for companies not ready for clinical stage development.

MF5

MF5 is our lead product for the treatment of menopausal symptoms such hot flashes, nighttime awakening and mood changes. MF5 has the potential of serving millions of women suffering from menopausal symptoms world-wide.

In the past year we were able to optimize the chemistry of the drug and select a drug candidate. We significantly improved the drug potency (we need a far lower dose) and the drug selectivity toward the ERβ. We also made headway in understanding the structure activity relationship of our compound with the full-length receptor, a fit we hope to be the first to accomplish. The potent compound is bioavailable with oral administration.

In animal studies we demonstrated that unlike estrogen our compound does not result in uterine proliferation. We also showed that low dose of the drug improves temperature irregularities in oophorectomized mice following rigorous exercise, a model of hot flashes. We are also engaged in mechanistic studies that demonstrate the effect of our drug on temperature sensing and temperature regulation, critical for the treatment and prevention of menopausal hot flashes.

We are planning to engage with the FDA on the future development plan for MF5.

BZ2

Using AI aided computational modeling we generated medicinal chemistry of analogs to the active compounds. These compounds were proven to be difficult to synthesize. We are now optimizing the synthetic paths to reach high potency and selectivity. We also initiated in depth biological and structural studies of the mechanisms of BZ2 cancer selective killing effect.

Discussion with the FDA will take place following the final candidate drug selection.

MD1

MD1 is based on the unique discovery Iaterion made in the field of nuclear receptors (the main hormone receptors such as estrogen, progesterone, testosterone, thyroid and glucocorticoids). The canonical model in biology is that protein nuclear receptors are regulated by a single compound (ligand) binding at a unique binding site in the ligand binding domain. The unique, almost singular, structure of this domain allows interaction with only specific chemical structures. We discovered a unique set of compounds that bind to the estrogen receptor alpha (ERα) that on their own result in no regulating activity, but when combined with the natural hormone, estrogen, they significantly modify estrogens activity. We termed these Co-ligand compounds nuclear receptor reprogramming (NRRP) drugs. This discovery changes the canonical model, where now at least two compounds can co-bind to the receptor and result in modification of the biological outcomes. This discovery may result in a new field in molecular toxicology, potentially explaining why, beyond differences in genetics and metabolism, people experience dramatic differences when exposed to drugs.

We were able to optimize greater potency, selectivity and desired programming activity for our compounds. These drugs can be utilized for multiple diseases where estrogen is used to increase specificity and improve long-term safety.

2025-26 in view

We are looking forward to engaging in formulation and toxicology studies for MF5, a pre-IND discussion with the FDA and hopefully the initiation of Phase 1 clinical trial toward the end of 2026.

Despite the uncertainty in our sector, we are very optimistic about Iaterion’s prospect of succeeding in both the development process as well as in securing future funds for continued development.

We look forward to reporting the next steps and the initiation of phase 1 clinical trial for MF5.

Forward Looking Statements

This release contains certain forward-looking statements relating to the business of Iaterion, Inc. that can be identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Iaterion, Inc. is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.