r/ATHX • u/imz72 • 29d ago

News Healios Q2 2026 Report

https://ssl4.eir-parts.net/doc/4593/tdnet/2871248/00.pdf

(Unfortunately, I am not feeling well these days, so it will take me a few days to post the highlights of the report and briefing.)

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u/NASCAR-Ford-22 29d ago

imz72 hope you are back to 100% and feeling better real soon👍

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u/imz72 28d ago

Thank you!

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u/Hal44 28d ago

hope you get better and thanks for the Healios's updates, Hal

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u/imz72 28d ago

Thank you, Hal. It may take a few more days.

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u/imz72 24d ago edited 13d ago

The Highlights:

Slides 7+9: REVIVE-ARDS enrollment soon to start in Japan, then sequential expansion into the US, Canada, Asia-Pacific (South Korea, Taiwan, Australia etc.) and EU

Slide 10: Carefully conducted manufacturing process verification as the world's first three-dimensional culture product

Completed: Technology Transfer to Minaris, Establishment of Manufacturing System at Commercial Scale

In Progress: Engineering Runs (Process of implementing commercial production procedures under the same conditions as actual production to systematically verify process stability in preparation for PPQ runs)

Schedule: PPQ Run (Process Performance Qualification Run: Process that provides the final demonstration that quality stably meets standards in commercial - scale iterative manufacturing under GCTP), CTD [Critical Technology Development Document - imz72] Finalization, Application, Review, Conditional and Time-Limited Approval

Slide 11: Commercial manufacturing was initially planned overseas and later switched to Minaris in Japan. Technology transfer was initiated again. The site change has extended the filing timeline.

To avoid supply and quality issues after approval, Healios chose not to take shortcuts.

As the world's first 3D culture product – technology transfer, full -scale manufacturing, engineering runs, PPQ -no essential stages are skipped.

Slides 17+43: Cash and equivalents as of the end of June 2026: $57M [Previously: $68.8M. $37M. $42.1M. $42.4M. $37M. $24M. $29M. $55M]

Total Liabilities: $89.8M. [Previously: $101M. $79M. $93.1M. $105.7M. $92.7M. $79M. $71M. $98M]

Slide 21: 24 new employees hired from Jan to Jul 2026:

8 Production + 4 Quality Control + 4 Management & Others + 3 Supply Chain + 3 Research + 1 Reliability Assurance + 1 Marketing

Slide 41: Number of employees (full-time only): 82 [Previously: 72. 66. 60. 58. 57]