The Setup into Ph3 LEVEL Data (3Q26)

研报英文原文证据摘录

The Setup into Ph3 LEVEL Data (3Q26)

June 24, 2026

and whether it's enough across a broad population to drive widespread

adoption.

Here's the bull case (and where we stand):

●PH-HFpEF remains a massive unmet need.

●Prior levosimendan data support improvements in exercise capacity

and cardiac performance.

●TNX-103's preload reduction mechanism may be uniquely suited for

PH-HFpEF physiology.

●Even a high-teens effect size (>15m on 6MWD) could support

meaningful uptake given the lack of approved alternatives.

●And the bigger the delta on 6MWD, the bigger the commercial

opportunity becomes.

The bear case centers on effect size:

●PH-HFpEF has historically been a difficult indication (although prior

failures don't necessarily apply to TNX-103).

●Heterogeneity of the patient population may dilute treatment effects

(CpcPH and IpcPH).

●Polypharmacy: a high % of patients are expected to be in SGLT2

inhibitors. Could there be a ceiling effect on the correlation between

lowering preload and 6MWD improvements?

●There are some limitations from the phase 2 HELP trial (which we run

through in detail in our initiation report above).

The Bar for Success in PH-HFpEF

Hitting stat sig on 6MWD is the gate: The primary endpoint is placebo-

adjusted change in 6-minute walk distance (6MWD), and statistical

significance is the minimum bar for successful. If LEVEL hits, TNX-103

becomes a potentially approvable asset and likely the first credible

registration program in PH-HFpEF.

But effect size still matters (and ideally >20 meter delta): The study

(n=230) is powered at >90% to detect a 25-meter treatment effect,

assuming a 55-meter standard deviation and 10% dropout rate.

Here's how we're thinking about the 6MWD data:

●≥25 meters = exceptional outcome

●20-25 meters = clear win