Dec. 3 at 3:56 PM
$TECX — Piper Investor Conference Review (Yesterday)
Overall Takeaway:
TECX provided one of its most de-risking updates to date: clean unblinded DSMB results, enrollment moving entirely to PVR > 3 patients, and a critical clinical clarification about patient susceptibility following recent cardiac events — a factor that materially differentiates TECX’s study design from Lilly’s flawed program. This remains the primary reason the stock is not already trading at 2× current levels.
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1. DSMB Review (Sept 30) — Clean With Unblinded Safety Data
• DSMB reviewed unblinded safety data through September 30.
• No safety signals detected.
• Hospitalization rates remained low.
• Management emphasized increased confidence as patient-months accumulate.
Investor Takeaway:
This significantly reduces any lingering fear of a “class effect” linked to Lilly.
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2. Enrollment Update — All New Patients Will Be PVR > 3
• Enrollment is not yet fully complete, but continues to progress well.
• TECX confirmed a strategic protocol shift:
→ All patients moving forward will have baseline PVR > 3.
• Advantages:
• Higher hemodynamic pressure at baseline
• Stronger treatment-effect visibility
• Cleaner statistical signal
• Reduced heterogeneity from milder populations
Investor Takeaway:
This materially improves the probability of achieving statistical significance on primary and secondary endpoints.
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3. Long-Term Data Expected to Support HFpEF / HePHRF Expansion
• Upcoming longer-duration data will be central to expanding into HFpEF and HePHRF populations.
• TECX emphasized that durability, safety stability, and functional outcomes will guide regulatory and commercial expansion.
Investor Takeaway:
Represents a major TAM expansion and future value driver.
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4. Expanded on Lilly’s Failure (NOT a Class Issue)
• Lilly’s trial enrolled extremely sick, recently decompensated patients, including those within days of major cardiac events — the exact population prone to fluid buildup and adverse events independent of therapy.
• TECX’s trial avoids this high-risk window, preventing confounding noise.
• Additionally, Lilly’s molecular construct was suboptimal, which further impaired the program’s odds.
• Importantly, another competitor continues to advance a similar mechanism, validating the class and reinforcing that Lilly’s outcome was:
• study-design related,
• patient-selection related, and
• molecule-specific — not mechanism-specific.
Investor Takeaway:
This is the single biggest lingering misunderstanding in the market. TECX’s data and design eliminate the confounders that derailed Lilly’s trial, meaning Lilly’s failure is not a read-through and should not weigh on TECX’s valuation.
