Topic: MDX2001 data disclosure timing, dose escalation, and NGENLA profit share guidance
Key points:
25 patients dosed in MDX2001; signs of efficacy seen but too early for formal report; will not go to much higher dose level; results from Phase Ia will be announced at an upcoming conference, and Phase Ib will start for most promising tumors; results shareable by end of 2026.
NGENLA profit share in Q4 was $12.5 million, driven by certain regions moving up in tiering structure (one region hit third tier) and Pfizer gaining global market share.
FY2026 profit share guidance is $34 million–$37 million, deemed achievable at current growth rates; could accelerate with further global wins.
Mgmt stance: Neutral to bullish on MDX2001 (cautious on formal data release timing, but confident in advancing); bullish on NGENLA (growth ahead of expectations, guidance achievable).
Q2 — Lut Ming Cheng
Topic: BioReference 4Kscore growth drivers and Merck EBV vaccine study updates
Key points:
4Kscore revenue growth (6%) came from urology field only, not primary care; no meaningful primary care effort yet; working with payers for coverage; expects high-single-digit to low-double-digit growth in 2026, could accelerate with primary care payer progress.
Merck EBV vaccine: ongoing studies focus on EBV-naive patients and reducing age inclusion from 18+ to 12 years; Phase II is expected to start next year (2027), not 2026; data needed for decisions expected by end of 2026.
Mgmt stance: Neutral to bullish on 4Kscore (stable growth trajectory, payer expansion potential); neutral on EBV (encouraging initial data but final go/no-go decision remains with Merck).
Q3 — Yale Jen
Topic: EBV vaccine go/no-go decision and GLP-1/glucagon combo asset status
Key points:
Merck’s final go/no-go decision is for Merck to announce; OPK team is encouraged by data thus far; current studies aim to ensure seamless Phase II → Phase III → launch with same batches/preparations.
GLP-1/glucagon (oxyntomodulin) is at late stages of IND submission; oral formulation with Entera is being pursued based on promising December results; injectable ready for Phase I once IND cleared.
Mgmt stance: Neutral on EBV (deference to Merck, but internally encouraged); bullish on GLP-1/glucagon (progressing toward clinical stage).
Q4 — Edward Tenthoff
Topic: In vivo CAR-T platform and MDX2004 immune rejuvenator development
Key points:
In vivo CAR-T uses lipid nanoparticles with covalently conjugated targeting antibodies; cargo can be mRNA or DNA; can target T cells, B cells, NK cells; CAR-T receptor can be monospecific or multispecific; program advanced in CMC and nonhuman primate experiments; high incoming interest.
MDX2004 is an immune rejuvenator (accelerator, not just brake-remover like PD-1); being tested in 2-arm trial: PD-1 naive and PD-1 previously exposed patients; 8 patients dosed so far; going well with no safety issues mentioned.
Mgmt stance: Bullish on in vivo CAR-T (versatile platform, large value component of ModeX); neutral to bullish on MDX2004 (early but promising tolerability and broad potential beyond tumors).
Q5 — Eduardo Martinez-Montes
Topic: Clinical milestones for MDX2001/MDX2004 in 2026 and BioReference expense guidance
Key points:
MDX2001 2026 milestones: completion of dose regimen and entry into Phase Ib; MDX2004: complete Phase Ia escalation within 2026, determine optimal dose; Phase Ia for MDX2004.
Total expense guidance $725 million–$750 million; expense expansion is coming from R&D efforts (dependent on program success and timing); BioReference operating expenses should see stable or reductions.
Mgmt stance: Neutral on clinical timelines (clear but dependent on ongoing studies); cautious on total expense (increase driven by R&D, but operating costs declining at BioReference).