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The year 2026 thus far was focused on science, advancing our programs.
- We optimized MF5 our estrogen receptor beta (ERβ) selective & GPER1 agonist drug for the treatment of menopausal symptoms and the prevention of breast cancer.
- 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.
- We continued the optimization of MD1 our first in class nuclear receptor reprogramming drug (NRRP).
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 continues to face difficult times. Changes proposed to the structure and funding of the NIH and the way in which the FDA reviews drugs have been implemented and are now being streamlined. Pharmaceutical pricing is under pressure from the U.S. government, which threatens investments in new products. Global economic instability continues making the funding environment challenging. There is a 16% year to year increase in the biotech workforce layoffs. For companies executing layoffs, the median reduction size was a severe 39% of their workforce, reflecting deep structural slashing rather than minor trims. According to J.P. Morgan’s Biopharma Licensing and Venture Report, the decline is characterized by a significant drop in both total capital (-38%) deployed and early-stage deal counts (-17% in Q1, 2026). Multiple companies had to shut down operations and the secondary venture market is flooded.
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 six months we engaged in optimization and scale-up the chemistry of the drug candidate. We made significant headway to expand the drug’s indications to genitourinary syndrome of menopause (GSM), formerly vulvovaginal atrophy (VVA) affecting 50% of menopausal women worldwide. Further, we demonstrated that MF5 will treat younger women with polyendocrine metabolic ovarian syndrome (PMOS) formerly polycystic ovarian syndrome (PCOS). PMOS is the most common endocrine female disorder affecting 6%- 13% of menstruating women world-wide.
The mechanisms of MF5 for the treatment of vasomotor symptoms, vaginal dryness and PCOS were elucidated in various systems and show differential effect in the appropriate tissues. The genes and signaling pathways anchor the drug’s potential.
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. We continue to optimize the compounds to reach high potency and selectivity. We are continuing an 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. We now have structural observations proving such interaction, providing a breakthrough in the field. We are now focusing on the utility of these drugs considering their effect on cellular proliferation both malignant and benign, such as uterine fibroids and endometrial hyperplasia.
2026 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 or early 2027. We are also engaged in various business development discussions with several biopharmaceutical companies.
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 recently secured additional funding from Capital K, Menlo Park, CA a venture capital company.
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.


