Immunic, Inc. · NASDAQ:IMUX
Immunic — Q1 2022 Earnings Presentation
21 slides from Immunic's earnings presentation, May 10, 2022
Slide 1: Immunic Therapeutics First Quarter 2022 Financial Results and Corporate Update
Immunic Therapeutics First Quarter 2022 Financial Results and Corporate Update NASDAQ: IMUX | May 10, 2022
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements This presentation contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities
Slide 3: Agenda
Agenda First Quarter 2022 Financial Results and Corporate Update 01 First Quarter 2022 and Subsequent Highlights 04 Q&A Session 02 Financial and Operating Results 05 Summary and Highlights 03 Anticipated Clinical Milestones 3 | © Immunic, Inc. | May/10/2022
Slide 4: First Quarter 2022 and Subsequent Highlights
01 First Quarter 2022 and Subsequent Highlights
Slide 5: February 2022: Presented Preclinical Data for Vidofludimus Calcium at ECCO
February 2022: Presented Preclinical Data for Vidofludimus Calcium at the 17th Congress of ECCO Highlights Include: § Vidofludimus calcium reduces proinflammatory immune cell responses by inducing regulatory macrophages, reducing pro-inflammatory cytokine secretion and reducing T cell proliferation.
Slide 6: February 2022: Announced Blinded Baseline Characteristics of Phase 2 CALDOSE-1 Trial
February 2022: Announced Blinded Baseline Characteristics of Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in UC The Main Blinded Baseline Characteristics of the CALDOSE-1 Trial Include: § 263 moderate-to-severe UC patients were enrolled in 78 study sites § 83% were biologically naïve and 17% were
Slide 7: February 2022: Received Notice of Allowances for Composition-of-Matter Patents for IMU-935
February 2022: Received Notice of Allowances for Composition- of-Matter Patents for IMU-935 Received Notice of Allowance from the U.S. Patent and Trademark Office for patent application 16/644581, entitled, “IL-17 and IFN-gamma inhibition for the treatment of autoimmune diseases and chronic inflamma
Slide 8: March: Announced Promotion of Glenn Whaley to Chief Financial Officer
March: Announced Promotion of Glenn Whaley, CPA, to Chief Financial Officer Glenn Whaley, CPA, who has served as Vice President Finance, Principal Financial and Accounting Officer since April 2020, has been promoted to the position of Chief Financial Officer on March 10, 2022. 8 | © Immunic, Inc. |
Slide 9: May: Announced Start of Patient Cohorts in Phase 1 Trial of IMU-856
May: Announced Start of Patient Cohorts in Ongoing Phase 1 Clinical Trial of IMU-856 in Patients with Celiac Disease Double-blind, randomized, placebo-controlled phase 1 study performed in three parts: § Safety and pharmacokinetics in healthy human subjects (Part A: single ascending doses, Part B: m
Slide 10: Financial and Operating Results
02 Financial and Operating Results
Slide 11: Consolidated Statements of Operations
Consolidated Statements of Operations (In thousands, except share and per share amounts, unaudited) Three Months Ended March 31, 2022 2021 Operating expenses: Research and development $ 17,445 $ 11,519 General and administrative 3,990 3,618 4SC Royalty Settlement — 17,250 Total operating expenses 21
Slide 12: Anticipated Clinical Milestones
03 Anticipated Clinical Milestones
Slide 13: Vidofludimus Calcium in Ulcerative Colitis
Vidofludimus Calcium in Ulcerative Colitis Top-line data of the induction phase of the phase 2 CALDOSE-1 trial of vidofludimus calcium in moderate-to-severe UC are expected to be available in June of 2022. 13 | © Immunic, Inc. | May/10/2022
Slide 14: IMU-935 Phase 1 Program: Part C in Psoriasis
IMU-935 Phase 1 Program: Part C in Psoriasis Initial results from the third portion of the phase 1 clinical trial of IMU-935 in patients with moderate-to-severe psoriasis are expected to be available in H2/2022. 14 | © Immunic, Inc. | May/10/2022
Slide 15: IMU-935 Phase 1 Trial in CRPC
IMU-935 Phase 1 Trial in CRPC Principal Investigator Initial clinical safety data from the open-label phase 1 dose escalation Johann Sebastian de Bono, M.D., Ph.D. trial of IMU-935 in patients with Regius Professor of Cancer Research and Professor in progressive metastatic CRPC are Experimental Canc
Slide 16: IMU-856 Phase 1 Program
IMU-856 Phase 1 Program The SAD part of the ongoing phase 1 clinical trial of IMU-856 has been completed. Based on the favorable data available so far, the Ethics Committee in Australia has agreed to proceed to the MAD part which is currently being dosed. Unblinded safety data from the SAD and MAD p
Slide 17: Multiple Clinical Data Readouts for All Three Development Programs Expected Throughout 2022
Multiple Clinical Data Readouts for All Three Development Programs Expected Throughout 2022 Program Target Preclinical Phase 1 Phase 2 Phase 3 Key Milestones Relapsing Multiple Sclerosis (RMS) – ENSURE Trials § RMS interim analysis planned after approx. half of the events occurred Progressive Multip
Slide 18: Q&A Session
04 Q&A Session
Slide 19: Summary and Highlights
05 Summary and Highlights
Slide 20: Multiple Clinical Data Readouts for All Three Development Programs Expected Throughout 2022
Multiple Clinical Data Readouts for All Three Development Programs Expected Throughout 2022 Advanced clinical pipeline: Oral IL-17 inhibitor IMU-935: three differentiated products in various phases of proof-of-concept data in psoriasis expected in clinical development H2/2022; further development in
Slide 21: Thank You!
Thank You! Immunic, Inc. 1200 Avenue of the Americas Immunic AG New York City, NY 10036 Gräfelfing (Munich) USA Germany Immunic Research GmbH Weinberg Campus Halle (Saale) Jessica Breu Germany Head of IR & Communications Phone: +49-89-2080477-09 Email: [email protected] Immunic Australia Pty. Ltd. Web: ww