1Q26 Reports: TNX-103's Ph3 LEVEL On-Track for 3Q26 Topline & Mgmt Meetings on May 27/28

研报英文原文证据摘录

1Q26 Reports: TNX-103's Ph3 LEVEL On-Track for 3Q26 Topline & Mgmt Meetings on May 27/28

C O M PA N Y N O T E

M a y 1 2 , 2 0 2 6

...in 6MWD it effectively de-risks Ph3 LEVEL-2 to also have a positive outcome where mgmt

noted we should not necessarily expect a greater magnitude of 6MWD benefit (as this tends to

rapidly improve without evidence suggesting a deepening of effect over time). Instead, a longer 6-

month+ treatment duration may provide the opportunity for TNX-103 to show signs of remodeling

effects that would be too early to observe at ~3-months. Further, ~1/3 of the Ph3 LEVEL-2 patient

population will continue out to an entire full-year of blinded treatment in order to instill extra

conviction that the totality of data supports safety requirements (n=100 out to 12-month under

double-blind, placebo-controlled treatment; in addition to the n=300 out to 6-months). As added

evidence of strong translation, both LEVEL and LEVEL-2 have the same patient selection criteria

and dosing scheme which bolsters high readthrough between the two trials (though LEVEL is

in North America and LEVEL-2 is global).

TENX has strengthened their leadership team to appoint Thomas Staab as CFO, Timothy

Healey, MBA as CCO and So-Young Kim, MD as EVP of Clinical Development and Strategy.

In addition, recognize that TENX has recently made multiple appointments to strengthen

their leadership team. Specifically, in April TENX announced their appointment of Thomas

Staab, II as CFO, highlighting his 25 years of experience within the healthcare industry

where he previously was CFO of LENSAR (LNSR, not covered), BioCryst Pharmaceuticals

(BCRX, not covered), Inspire Pharmaceuticals (acquired by MRK, not covered), and Triangle

Pharmaceuticals (acquired by GILD, not covered).