The Company provides the following explanations regarding recent media focus on Lumosa’s Phase 2 clinical trial conducted by its Chinese Partner, Shanghai Pharma, which did not disclose trial data, p-value, or future publication plans for the trial data:
(1) Regarding the disclosure of study data
Lumosa has not yet obtained the complete clinical trial report from Shanghai Pharmaceutical, and currently only possesses trial data information. As the development and commercial rights in the Chinese region was licensed to Shanghai Pharmaceutical, Lumosa’s announcement must align with that of Shanghai Pharmaceutical’s. The ownership of trial data belongs to Shanghai Pharmaceutical, and they have not yet agreed to disclose relevant information due to their business strategy. Therefore, without obtaining Shanghai Pharmaceutical’s consent, Lumosa cannot unilaterally disclose trial data. Thus, Lumosa immediately convened a material information press conference and an institutional investors’ conference upon receiving the trial results from Shanghai Pharmaceutical and disclosed the information in strict accordance with Shanghai Pharmaceutical’s notification and announcement. Lumosa will disclose relevant data in detail in accordance with Shanghai Pharmaceutical’s notification and announcement in the future.
(2) Explanations for not announcing the p-value
This trial was the first multi-dose Phase 2 dose-exploration study for LT3001, designed to assess drug safety and explore effective dosage. The primary objective was to confirm the study drug’s tolerability and dosage range. The study results have achieved the preset goals and demonstrated excellent tolerability. As Phase 2 trials are primarily exploratory in nature, a p-value is not a necessary component. The present trial did not pre-establish statistical hypotheses, nor was a p-value test planned. Without statistical hypothesis, generating p-value data would hold no practical significance and would not align with trial design principles.
Generally, p-values are typically applicable to Phase 3 clinical trials, used to determine efficacy significance and statistical verification, serving as critical reference data to support drug approval applications – not for Phase 2 exploratory trials. This trial’s design focused on confirming safety and exploring efficacy signals, and did not include definitive efficacy verification analysis.
As a new molecular drug with novel mechanism, LT3001 had unknown efficacy indicator differences compared to the control group prior to the trial. Consequently, the trial design did not include p-value analysis. Currently, Lumosa does not possess p-value data. Should such data be generated in the future, the Company will proceed with announcements as instructed by Shanghai Pharmaceutical, ensuring information disclosure complies with relevant regulations.
(3) Plans for future trial data publication
The future publication for trial data will proceed according to Shanghai Pharmaceutical’s strategy. Although Lumosa is unable to immediately announce trial data results due to Shanghai Pharmaceutical’s comprehensive considerations, this situation does not impact the progression of subsequent development plans. The results of this trial represent critical data supporting future development. Lumosa will comprehensively evaluate the results from present Chinese Phase 2 clinical trial results, and other that from other multi-nation, multi-center Phase 2 trials, and carefully plan the implementation of Phase 3 clinical trials. The value and application of these study results are not affected by their publication status.
Please refer to the video recording and slide presentation of the institutional investors’ conference held by Lumosa data November 29, 2024, on the “Market Observation Post System (MOPS)” or Lumosa company website (
https://www.lumosa.com.tw/investor/investor_conference).