Founded in 2017 and based in Barcelona, FreeOx Biotech was born out of a deep commitment to change the lives of millions. FreeOx is developing a breakthrough treatment for acute ischemic stroke (AIS), a devastating emergency that strikes when a blood clot obstructs a brain artery, causing rapid and often irreversible damage. Every year, 13 million people around the world are affected by this life-threatening event.
Stroke strikes fast…
Stroke strikes in an instant, unpredictably, and anyone. The most frequent stroke type is acute ischemic stroke (AIS) where a blood clot obstructs a brain artery. During the most severe AIS events (38% of cases) called large vessel occlusions (LVO), 2 million neurons die every minute.
Despite advances in emergency stroke care for treating acute ischemic stroke (AIS), such as mechanical thrombectomy (MT), the medical procedure to remove a blood clot from a brain artery, and current standard of care, over 50% of victims remain severely disabled.
All current treatments focus exclusively on reopening the affected brain artery (recanalization). However, recanalization does not ensure that blood flow is restored to the brain and neurons, because small brain vessels (microcirculation) shut down during a stroke. Reperfusion, reopening the brain microcirculation, is the missing piece in stroke treatment. Today, over 85% of AIS victims survive – but at what cost? Stroke-related disabilities drastically impact their ability to carry out daily activities independently, disrupting family quality of life, and creating a massive financial burden on society (e.g. >$100 billion annually in US).
…FreeOx strikes back, protecting your brain, preserving your life
FreeOx’s lead candidate, Ox-01, is a patented proprietary form of an endogenous compound. Ox-01 is designed to be administered during MT procedures to restore small brain vessels (microcirculation), preserving the brain from reperfusion injury – which occurs in up to 50% of cases. Ox-O1 acts on the entire neurovascular unit. It is a powerful cerebroprotectant, reopening microcirculation and saving neurons from reperfusion injury. Designed to work in combination with current standard of care (procedures and drugs), it integrates seamlessly into current emergency protocols, improving stroke outcomes without disrupting standard care.
Excellent data paving the way for clinical trial endorsed by the National Institutes of Health
In addition to an excellent safety profile, Ox-01 demonstrated during a previous Phase 2b trial an outstanding 19% less patients that die or become disabled vs placebo, when added to MT. The combination showed an unprecedented 69% less patients that die or become disabled.
During a rigorous 5-year evaluation by the National Institutes of Health’s stroke division NINDS (National Institute of Neurological Disorders and Stroke), Ox-01 outperformed four competing stroke drug candidates – including three from major pharmaceutical companies – making it the most promising next stroke drug, and earning NINDS’ backing for a Phase 2b/3 trial. This multicenter Phase 2b/3 clinical trial – AURORA – will enroll 800 patients from 2026 and is supported by the NIH/NINDS through a non-dilutive funding of $30–$35 million. The last time NINDS made such a large commitment in stroke was in 1995, and it led to the approval of the only stroke drug, Genentech’s rtPA.
Strong IP protection and experienced team
Our intellectual property portfolio includes a composition of matter patent for the Drug Substance in Ox-01, giving FreeOx exclusive rights to make, use, sell, or import it until 2045 for AIS and beyond. The leadership team includes experts in stroke, drug development, regulatory strategy, and commercial partnerships, with experience in large-scale clinical development and biotech scale-up.
The missing piece in stroke treatment that patients and physicians have awaited for 30 years
Targeting patients suffering from LVOs, which represent more than 500,000 eligible patients in the U.S. and EU alone, at peak, and no approved cerebroprotective drug available, Ox-01 addresses a white space market exceeding €3 billion per year. Regulatory discussions with the FDA are ongoing.
The last opportunity to invest before market approval
To prepare for AURORA, an 800-patient Phase 2b/3 trial, FreeOx is raising €2.5 million via Capital Cell, with €1 million already secured by NeuroTechnology Investors co-leading the round. A Phase 2b/3 clinical data readout from AURORA is expected in 2028 and will serve as a key milestone to position the company for an exit via a deal with a major pharmaceutical company. FreeOx is currently in conversation with several pharma companies that have expressed interest in Ox-O1.
A x19 ROI potential with an exit window in 2029
This is your opportunity to invest in the world’s first cerebroprotective therapy for stroke patients – a transformative approach backed by robust science, endorsed by a $30 million- $35 million non-dilutive NIH/NINDS and a clear path to market.
