January, 20th, 2022. Follow us: LinkedIn / www.op2lysis.com

2021 has just ended and was thrilling regarding the advances in the development of O2L-001, the Best-In-Class therapy tailored for hemorrhagic stroke patients. 2021 was the year of small steps for Op2Lysis, before a giant leap for hemorrhagic stroke patient in the coming months. You will find below a few key events that punctuate the year. We also take the opportunity to wish all our investors, partners, readers, communities a happy New Year 2022.

Christophe Gaudin and Jérôme Parcq

Corporate achievements in 2021. Op2Lysis grew and opened a subsidiary in Liège (Belgium) where the development activities of the company are now driven. It was a strategic choice to move toward Liège, a region in full bloom in the fields of life sciences and biotechnologies, including developed ecosystem to support fast biotech break even and public funding to keep the pace of development. The affiliate, Op2Lysis Development SA, already hosts two employees specialized in regulatory development (CMC and toxicology). 6 people are now working full time to develop O2L-001 and the technological platform NANOp2Lysis. The company also receives the support from DGO6 (Belgium) and is laureate of the EIC Accelerator (cut-off 6). Op2Lysis will enter negotiations to maximize the investment of the EIC in 2022 (blended finance). This is a serious traction element for a Series A in 2022.

Technological achievements in 2021 Development of a clinical-size hematoma model was performed and offers the opportunity to test several parameters clinically impactful. We demonstrated the high efficacy of our therapeutic solution in the best translational model. The distribution of O2L-001 was evaluated in rodent and in large animal and cleared the way of the non-clinical regulatory program. The company validated its regulatory development plan in September 2021 at the opportunity of a pre-IND consultation with the US Food and Drug Administration (FDA).

Go to Market achievements in 2021 In order to develop a profitable business, several actions were led in 2021. The O2L-001 patent has been extended worldwide. Op2Lysis also wants to take advantage of the deep technology developed with O2L-001 and push forward this unique technology that allowed encapsulation of active enzyme as a technological platform, NANOp2Lysis, to fuel the pipeline of the company. New indications are now being evaluated to increase the portfolio of the company. Last but not least, FDA granted Orphan Drug Designation to OptPA, the optimized human tissue-type plasminogen activator developed by Op2Lysis, for treatment of intracerebral hemorrhage, which enhances the value of our O2L-001 project and promotes its acceleration and success.

Christophe Gaudin, MD
C:+33 607 97 90 08
Jérôme PARCQ, PhD
C:+33 615 27 09 69 / +32 460 21 43 07
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