Osmol Therapeutics, Inc.
June 16, 2025
Company Presentation
Oncology
Osmol is a clinical stage biopharma company advancing technology licensed from Yale to develop a first-in-class preventative treatment for chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a significant unmet need associated with microtubule-based chemotherapies such as taxanes, the most widely used breast cancer chemotherapy treatment and ADC’s. CIPN can be both debilitating and effect cancer treatment outcomes. There are no approved treatments for CIPN, leaving patients’ only option to reduce the dose or length of chemotherapy treatment. Osmol’s initial focus is in breast cancer where up to 80% of taxane treated patients develop CIPN and 50% have their dose or length of treatment adjusted.
Market research with breast cancer specialists and US payers covering 100M lives confirmed the significant need for effective CIPN treatments and willingness to reimburse the product.
The FDA completed its review of Osmol’s IND, notifying Osmol our Phase 1 clinical study may proceed.
Company HQ City:
Wake Forest
Company HQ State:
NC
Company HQ Country:
United States
Year Founded:
2016
Lead Product in Development:
OSM-0205 is a potent NCS1 stabilizer discovered by Dr. Barbara Ehrlich, Professor of Pharmacology at Yale School of Medicine. Calcium homeostasis is critical to the homeostasis of cellular function. NCS1 is a highly sensitive calcium sensor protein that maintains resting calcium concentrations and dynamically enhances responses to cell stimuli. Certain chemotherapy agents destroy tumor cells by disrupting microtubules. These agents also bind to NCS1 leading to off-target calcium dysregulation that causes neuronal atrophy subsequently resulting in CIPN and CICI. OSM-0205 is hypothesized to modulate NCS1 function preventing the chemotherapy induced calcium dysregulation and thereby averting CIPN and CICI , while not impacting the chemotherapy’s microtubule effect on tumor cells.
OSM-0205 is a patented intravenous formulation of an FDA-approved oral CNS medication following the 505(b)(2) regulatory pathway. The product is currently designed to be administered to patients 30 minutes prior to the chemotherapy infusion to protect neurons from off-target effects of the chemotherapy.
OSM-0205 has the potential to allow patients to not only avoid the debilitating effects of CIPN and CICI, but improve outcomes for the 50% of patients that have their chemotherapy dose adjusted or interrupted.
CEO
Bob Linke
Year Founded
2016
Development Phase of Lead Product
Phase I
Number of Unlicensed Products Looking for Licensing
1
When you expect your next catalyst update?
Completion of Phase 1 clinical study
What is your next catalyst (value inflection) update?
December, 2025
Website
www.OsmolTherapeutics.com
Primary Speaker
)
)
)
)
){kind=logo}
)
){kind=logo}