MDGL - Bull Thesis
BULL THESIS
MDGL overall corporate and executive summary
Pursuing novel therapeutics that target a specific thyroid hormone pathway in the liver
Cash thru key upcoming readouts and into early 2023
Lead candidate resmetirom for NASH has yielded promising late-stage clinical data
Recent Ph3 data in NAFLD provides more confidence for huge Q4 2022 Ph3 NASH readout
Several positive Ph2/3 liver disease trials that have shown robust improvements in lipid parameters that could eventually yield cardio risk-reduction success.
High unmet need - indication (NASH), with huge potential upside.
One of the frontrunners for possible approval in NASH
At least 1 yr ahead of VKTX therapeutic with same MOA
Resmetirom (MGL-3196) (THR-B Agonist)(NAFLD)
First-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR) β-selective agonist.
1/31/22 Positive Phase 3 MAESTRO-NAFLD-1 results. “MRI-PDFF reductions were robust, with nearly half of patients in the resmetirom 100 mg arm achieving a 50% PDFF reduction” (source)
Primary safety endpoints met
969 patient trial compared to VKTX 31 patients
MRI-PDFF %CFB (Week 16) -49% -53% (week 52)
LDLc %CFB (SE) (Week 24) -21
Stock increase from (~$57.58 (1/31/22) to ~$90.41(2/9/22)
Positive data gives more confidence for pivotal MAESTRO NASH catalyst this year
Resmetirom (MGL-3196) (THR-B Agonist)(NASH)
Potential to be the first approved candidate. Assuming competitor (ICPT) failure and $MDGL trial success this year.
Big Mover Event - Expect large price increase if trial is successful and/or running up to trial readout
Further in clinical development than competitor VK2809 (same MOA)
Over 1 year ahead of VKTX and probably years ahead of competition
Currently in MAESTRO NASH pivotal phase 3 trial, topline data due Q4 2022
(MRI-PDFF-MRE-AST) score to predict NASH on liver biopsyPositive Phase 2 results for NASH (source)
60.3% Percentage of patients attained ≥30% liver fat reduction
-36.3% Relative change in MRI-PDFF (% change from baseline, median)
Safety data - some loose stool but overall looks good, consistent with lower dose phase 2 safety data. Safe at 100mg vs 80mg for phase 2 NASH.
JM/MV 3/10/22
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