Morphic (MORF) investor relations material

Program execution and clinical trial progress

• Enrollment for the phase II ulcerative colitis trial is progressing well, with confidence in meeting guidance for data readout in the first half of 2025.

• The trial aims for a balanced patient mix, targeting at least 30% advanced therapy-experienced patients and a 50/50 split in Mayo Endoscopic Scores.

• The oral formulation's appeal is aiding recruitment, especially among patients who have not received ENTYVIO.

• A Crohn's disease study has been initiated, with patient screening underway and updates expected as enrollment progresses.

• Guidance on enrollment timing is expected to be narrowed within the next six months.

Efficacy, safety, and competitive landscape

• The goal is to achieve an approvable agent with a placebo-adjusted remission rate in the 10–15% range, comparable to orals and injectables in the space.

• Safety is emphasized as a key differentiator, with the oral agent showing a favorable profile similar to ENTYVIO in early data.

• The phase IIa trial showed high statistical significance on the primary endpoint and a 25–26% remission rate on the modified Mayo score.

• Competitors, including Gilead, are running similar phase II studies, but no data from their α4β7 compound is available yet.

• The company is developing early-stage oral IL-23 and TL1A programs, with potential for future combination therapies.

Financial position and strategic considerations

• Cash balance is around $700 million, with guidance suggesting funding extends well into 2027.

• There is no immediate need for financing, and the company feels capable of advancing to approval independently if needed.

• Strategic partnerships remain an option, with ongoing discussions but a focus on maximizing asset value.

• The asset is wholly owned, and the company is open to global partnerships to optimize development and commercialization.

• Expense management is closely monitored to ensure financial discipline.