Slide 1: IMVT-1402 Initial First-in-human Data Presentation
Targeted science, Tailored solutionsfor people with autoimmune disease IMVT-1402 Initial First-in-human Data Presentation September 26, 2023
Slide 2: Forward-Looking Statements
Forward-Looking Statements 2 This presentation contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "can," “may,” “might,” “will,” “would,” “should,” “
Slide 3: Our Vision: Normal Lives for People with Autoimmune Disease
Our Vision:Normal Lives for People with Autoimmune Disease 3 Love Trailblazing AllVoices Bolder, Faster What we do: We are developing targeted therapies that are designed to address the complex and variable needs of people with autoimmune diseases.
Slide 4: IMVT-1402 Selected to Deliver Maximum IgG Reduction While Minimizing Albumin Interference
4 Note: Ribbon representations generated from X-Ray crystal structure. Batoclimab solved at 2.4Å resolution. IMVT-1402 solved at 2.6Å resolution. Fc Albumin FcRn Batoclimab Fc Albumin FcRn IMVT-1402 Batoclimab: overlay with albumin and Fc IMVT-1402: overlay with albumin and Fc IMVT-1402 Was Selected
Slide 5: Goals for the Phase 1 Program
Achieve all of the above with a simple, commercially attractive subcutaneous injection Demonstrate minimal to no impact on LDL Demonstrate minimal to no impact on albumin 5 Goals for the Phase 1 Program Demonstrate potential best-in-class IgG reductions similar to batoclimab Note: Based on data to d
Slide 6: Best-in-Class Potential for IMVT-1402 as FcRn Inhibitor
6 Best-in-Class Potential for IMVT-1402 as FcRn Inhibitor Highlighted by Initial Phase 1 Safety and Pharmacodynamic Data Initial SAD and 300 mg MAD data demonstrated deep and rapid IgG reduction, similar to batoclimab, with 63% mean IgG reduction in the 300 mg MAD cohort after four doses Initial 300
Slide 7: IMVT-1402 Phase 1 Clinical Trial Objectives
7 Expeditiously evaluate safety, pharmacokinetic & pharmacodynamic profile Validate the IMVT-1402 dose that achieves FcRn saturation Confirm doses for future studies 2 3 1 IMVT-1402 Phase 1 Clinical Trial Objectives
Slide 8: Study Design for IMVT-1402 Phase 1 Clinical Trial in Healthy Volunteers
Study Design for IMVT-1402 Phase 1 Clinical Trial in Healthy Volunteers* 8 Single-Ascending Intravenous Dose Single-Ascending Subcutaneous Dose Multiple-Ascending Subcutaneous Dose Fixed 300 mg Fixed 100 mg Fixed 600 mg Fixed 300 mg Fixed 600 mg Fixed 300 mg Fixed 600 mg Single Ascending Dose 6 IMVT
Slide 9: Single-Ascending Subcutaneous Doses
Single-Ascending Subcutaneous Doses 9
Slide 10: IMVT-1402 SAD Data Suggests Potential Best-in-Class IgG Reduction Similar to Batoclimab
IMVT-1402 SAD Data Suggests Potential Best-in-Class IgG Reduction Similar to Batoclimab 10 IgG % change from baseline* Dose administration * Data presented are from separate clinical trials, not a head-to-head study, conducted by Immunovant. All IgG values in the IMVT-1402 arms showed a significant
Slide 11: IMVT-1402 SAD Data Suggests Potential Best-in-Class IgG Reduction Similar to Batoclimab
IMVT-1402 SAD Data Suggests Potential Best-in-Class IgG Reduction Similar to Batoclimab 11 Dose administration * Data presented are from separate clinical trials, not a head-to-head study, conducted by Immunovant. IgG % change from baseline*
Slide 12: IMVT-1402 Produced a Similar Effect on Albumin as Placebo
IMVT-1402 Produced a Similar Effect on Albumin as Placebo 12 Albumin % change from baseline* Dose administration * Data presented are from separate clinical trials, not a head-to-head study, conducted by Immunovant. No albumin values in the IMVT-1402 arms showed a significant decrease from baseline
Slide 13: IMVT-1402 Produced a Similar Effect on LDL as Placebo
LDL % change from baseline* IMVT-1402 Produced a Similar Effect on LDL as Placebo 13 Dose administration No LDL values in the IMVT-1402 arms showed a significant increase from baseline (all p-values > 0.05) * Batoclimab phase 1 study did not measure LDL, so no comparison provided
Slide 14: Multiple-Ascending Subcutaneous Doses
Multiple-Ascending Subcutaneous Doses(Once-weekly dosing x 4 weeks) 14
Slide 15: IMVT-1402 300 mg MAD Data Suggests Potential Best-in-Class IgG Reduction
IgG % change from baseline* IMVT-1402 300 mg MAD Data Suggests Potential Best-in-Class IgG Reduction Similar to Batoclimab 15 Dose administration IMVT-1402 MAD 600 mg data on track for November 2023 * Data presented are from separate clinical trials, not a head-to-head study, conducted by Immunovant
Slide 16: IMVT-1402 300 mg MAD Data Suggests Potential Best-in-Class IgG Reduction
IMVT-1402 300 mg MAD Data Suggests Potential Best-in-Class IgG Reduction Similar to Batoclimab 16 Dose administration IMVT-1402 MAD 600 mg data on track for November 2023 * Data presented are from separate clinical trials, not a head-to-head study, conducted by Immunovant. IgG % change from baseline
Slide 17: IMVT-1402 300 mg MAD Data: No Albumin Reduction Compared to Baseline
Albumin % change from baseline* IMVT-1402 300 mg MAD Data: No Albumin Reduction Compared to Baseline After Four Weeks of Dosing 17 Dose administration No albumin values in the IMVT-1402 arms showed a significant decrease from baseline (all p-values > 0.05) IMVT-1402 MAD 600 mg data on track for Nove
Slide 18: IMVT-1402 300 mg MAD Data: No LDL Increase Compared to Baseline
LDL % change from baseline* IMVT-1402 300 mg MAD Data: No LDL Increase Compared to Baseline After Four Weeks of Dosing 18 Dose administration No LDL values in the IMVT-1402 arms showed a significant increase from baseline (all p-values > 0.05) IMVT-1402 MAD 600 mg data on track for November 2023 * B
Slide 19: IMVT-1402 Showed a Favorable Safety Profile in SAD / MAD Initial Data Set
19 IV SAD SC SAD SC MAD Placebo 100mg 300mg 600mg Placebo 300mg 600mg Placebo 300mg N = 6 n (%) N = 6 n (%) N = 6 n (%) N = 6 n (%) N = 4 n (%) N = 6 n (%) N = 6 n (%) N = 2 n (%) N = 10 n (%) Participants with at least one TEAE 4 (67) 4 (67) 3 (50) 3 (50) 3 (75) 4 (67) 5 (83) 2 (100) 7 (70) Partici
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Slide 21: Summary of IMVT-1402 SAD/MAD Data Reviewed
21 Summary of IMVT-1402 SAD/MAD Data Reviewed IMVT-1402 SAD/MAD data to date suggest potential for best-in-class IgG lowering with IMVT-1402 IMVT-1402 SAD/MAD data to date suggest potential best-case profile with respect to albumin and LDL impact IMVT-1402 data appeared similarly potent as batoclima
Slide 22: IMVT-1402 Has Potentially Best-In-Class Attributes to Address Large Unmet Need
Favorable Analyte Profile Initial Phase 1 data supports a favorable analyte profile with no or minimal effect on albumin and LDL * Not including any potential patent term extension 22 IMVT-1402 Has Potentially Best-In-Class Attributes to Address Large Unmet Need in Autoimmune Disease Novel, fully hu
Slide 23: Concluding Thoughts
Concluding Thoughts 23 Based on SAD / MAD data to date, IMVT-1402 has a potential best-in-class profile MAD 600mg SC cohort just starting with data expected in November 2023 Anti-FcRn market offers many attractive opportunities and a favorable development path