Lumosa Therapeutics Co., Ltd. Announces LT3001 Granted Fast TrackDesignation for the Treatment of Acute Ischemic Stroke toExpedite the Drug Registration Process with the US FDA. Lumosa received Fast Track Designation for its novel drug for the treatment of acute ischemic stroke from the US FDA after 60 days of reviewing. The designation allows LT3001 to receive additional assistance from the US FDA to facilitate the timeline for the drug registration process.

LT3001 is a novel small molecule, the target indication is for the treatment of acute ischemic stroke. Results of the Phase 2a trial completed last year showed that when administered to stroke patients within 24 hours of stroke onset, LT3001 demonstrated to be safe with no evidence of increased risks of symptomatic intracranial hemorrhage and showed potential in improving neurological behaviors and functions. Phase 2 clinical trial where multiple doses of LT3001 are administered concomitantly with mechanical thrombectomy is currently underway.

Fast track is a designation by the US FDA as an investigational drug for expedited review to facilitate the development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. It takes a considerable time to develop a new drug and the cost of development is relatively high. The success of the development is not guaranteed.

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