IKT

• Clinical Progress: Completed enrollment for the Phase 2 201 trial of risvodetinib in Parkinson's disease, expecting top-line data in November. Had productive engagement with the US FDA regarding IkT-001Pro's opportunity in pulmonary arterial hypertension, filed IND for PAH and plan to open Phase 2b clinical development. • Program Updates: Exploring alternative financing for risvo Multiple System Atrophy, including grant funding. Developing new antibody diagnostic and clinical biomarker tools for Parkinson's disease, with grant applications under review by NINDS. • IkT-001Pro: Filed IND for PAH, plan to conduct a Phase 2b study; scaled manufacturing and process development efforts for Pro to support late-stage clinical development and NDA batch requirements.

• Cash runway extended to December 2024, sufficient to fund operations through top-line data of the 201 trial. • Anticipate the back half of 2024 to accelerate momentum, with key milestones such as top-line data from the risvodetinib trial and the opening of clinical development for IkT-001Pro in PAH.

For the quarter ended June 30th, 2024, the net loss was $5.0 million or $0.66 per share, compared to a net loss of $5.8 million or $0.94 per share in the second quarter of 2023. Research and development expenses for the quarter were $3.1 million, down from $4.5 million in the same period the previous year. The decrease in R&D expenses was due to a $1.4 million reduction in IkT-001Pro expenses. Selling, general and administrative expenses were $2.0 million, up from $1.8 million in 2023, primarily driven by an increase in legal and consulting fees. As of June 30th, 2024, the company had $7.9 million in cash, cash equivalents, and marketable securities, with cash runway extending into December 2024.

• Potential delays in clinical trial enrollments and regulatory approvals. • Uncertainties regarding funding for ongoing and future clinical programs. • Risks associated with the success of clinical trials, including safety and efficacy outcomes not meeting expectations.

Q: Jason McCarthy asked about the lag time between the completion of the risvo Phase 2 study and the start of the open-label extension (OLE) and the potential for patients to opt for symptomatic treatment.

A: Milton Werner responded that 89 people had completed the trial, with the last person exiting in late September; preparatory work for the OLE is done, financial constraints mostly resolved, and the OLE is expected to launch in the coming months, with some patients possibly using symptomatic meds but in a small group so far.

Q: Jason McCarthy inquired about details of the Phase 2b study for IkT-001Pro.

A: Milton Werner stated the Phase 2b study is roughly 100 patients, placebo-controlled, with a 12-week safety review at half-enrollment and a 24-week futility analysis; designed to assess safety and potential efficacy to overcome imatinib's side effects, with the IND filed and expected to clear.

Q: Edward White asked about expectations for IND clearance of IkT-001Pro and gating factors.

A: Milton Werner said it will take 9-12 months to gear up the trial, relying on proper site selection, clinical investigators, and capital; the prodrug has positive preclinical and clinical data, increasing the chances of success despite capital needs.

Q: Edward White further asked about expectations for risvo Phase 2 data.

A: Milton Werner said the trial enrolled uniform Parkinson's patients with substantial disability; top-line data in November will show trends across assessments and biomarker studies, potentially supporting Phase 3 without further studies, with the open-label extension study to launch soon.