izumerogant (IMU-935) / Immunic - LARVOL DELTA

Orally Bioavailable RORγ/DHODH Dual Host-Targeting Small Molecules with Broad-Spectrum Antiviral Activity. (PubMed, Antiviral Res) - "In a SARS-CoV-2 mouse model, treatment with a dual inhibitor alone, or in combination with molnupiravir, reduced the viral load by 7- and 58-fold, respectively. Considering the clinical safety, oral bioavailability, and tolerability of izumerogant in a recent Phase I study, izumerogant-like drugs represent potent dual-targeting antiviral HDAs with pronounced broad-spectrum activity for further clinical development."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • ROR1

Immunic, Inc. Reports First Quarter 2024 Financial Results and Provides Corporate Update (PRNewswire) - "Research and Development (R&D) Expenses were $18.7 million for the three months ended March 31, 2024, as compared to $22.9 million for the three months ended March 31, 2023. The $4.2 million decrease reflects (i) a decrease of $2.4 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer and (ii) a $2.5 million decrease in external development costs related to the vidofludimus calcium and IMU-856 programs."

Commercial • Castration-Resistant Prostate Cancer • Crohn's disease • Genito-urinary Cancer • Immunology • Inflammatory Bowel Disease • Multiple Sclerosis • Oncology • Prostate Cancer • Psoriasis • Rheumatoid Arthritis • Solid Tumor • Ulcerative Colitis

IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=18 | Terminated | Sponsor: Immunic AG | N=42 ➔ 18 | Trial completion date: Dec 2023 ➔ May 2023 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2023 ➔ May 2023; Lack of Efficacy

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Immunic, Inc. Reports First Quarter 2023 Financial Results and Provides Corporate Update (PRNewswire) - "Research and Development (R&D) Expenses were $23.0 million for the three months ended March 31, 2023, as compared to $17.4 million for the three months ended March 31, 2022...a $0.2 million increase related costs across numerous categories. The increases were partially offset by a decrease of $0.9 million in external development costs related to the phase 2 clinical trial of vidofludimus calcium in ulcerative colitis and the IMU-935 program."

Commercial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Safety, Tolerability, and Pharmacokinetics of IMU-935, a Novel Inverse Agonist of Retinoic Acid Receptor-Related Orphan Nuclear Receptor γt: Results From a Double-Blind, Placebo-Controlled, First-in-Human Phase 1 Study. (PubMed, Clin Pharmacol Drug Dev) - "The PK of IMU-935 were dose proportional with a half-life of ≈24 hours. In conclusion, IMU-935 was safe with no dose-limiting toxicities and had a PK profile that supports once-daily dosing."

Journal • P1 data • PK/PD data • Immunology • IL17A

IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Immunic AG | Trial primary completion date: Aug 2022 ➔ Mar 2023

Metastases • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CTCs

Immunic, Inc. Announces $60.0 Million Oversubscribed Private Placement Equity Financing (PRNewswire) - "Immunic, Inc...announced it has entered into a securities purchase agreement (the 'Purchase Agreement') with select accredited investors and certain existing investors to issue and sell an aggregate of 8,696,552 shares of its common stock ('Common Stock') at a price of $4.35 per share, reflecting a 10% premium to the closing price on October 7, 2022 on NASDAQ, and pre-funded warrants ('Pre-Funded Warrants') to purchase up to an aggregate of 5,096,552 shares of Common Stock at a purchase price of $4.34 per pre-funded warrant share, through a private investment in public equity ('PIPE') financing....The Company intends to use net proceeds from the financing to fund the ongoing clinical development of its three lead product candidates, vidofludimus calcium (IMU-838), IMU-935 and IMU-856, and for other general corporate purposes."

Commercial • Immunology • Inflammatory Bowel Disease

Immunic, Inc. Reports Second Quarter 2022 Financial Results and Provides Corporate Update (PRNewswire) - "Research and Development (R&D) Expenses were $16.5 million for the three months ended June 30, 2022, as compared to $15.7 million for the three months ended June 30, 2021. The $0.8 million increase reflects (i) a $4.0 million increase in external development costs related to the ongoing clinical trials of vidofludimus calcium for the phase 3 program in RMS and the phase 2 trial in PMS and IMU-935...The increases were partially offset by (i) a $3.2 million decrease in external development costs related to clinical trials of vidofludimus calcium related to COVID-19 and UC, and (ii) a decrease of $0.7 million across numerous categories."

Commercial • Immunology • Inflammatory Bowel Disease • Psoriasis

Immunic, Inc. Reports Second Quarter 2022 Financial Results and Provides Corporate Update (PRNewswire) - P1 | N=42 | NCT05124795 | Sposnor: Immunic AG | "The first two dose cohorts of the phase 1 clinical trial of IMU-935 in mCRPC have been fully recruited, with 6 patients enrolled in the 300 mg cohort and 6 patients in the 600 mg cohort. Of these patients, all have completed the initial 28-day safety study part without reaching dose limiting toxicity (DLT). The third, 900 mg cohort is expected to start dosing soon. Initial safety data available so far show a promising safety profile of IMU-935 in mCRPC, with only benign adverse events and no dose limiting toxicities. Immunic plans to provide a more comprehensive update on safety and also on potential signs of anti-tumor activity of IMU-935 in this trial as soon as data from the planned dose expansion part are available."

P1 data • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Immunic, Inc. Reports First Quarter 2022 Financial Results and Provides Corporate Update (PRNewswire) - "Immunic, Inc...today announced financial results for the first quarter ended March 31, 2022 and provides a corporate update....IMU-935 phase 1 program in psoriasis patients: Recruitment of part C of the phase 1 clinical trial of IMU-935 in patients with moderate-to-severe psoriasis is ongoing in Australia and New Zealand. In addition, the part C portion of the trial has been submitted to authorities in Bulgaria and North Macedonia in order to expedite enrollment. Initial results from this third portion of the phase 1 clinical trial are expected to be available in the second half of 2022."

P1 data • Trial status • Immunology • Psoriasis

Immunic, Inc. Reports Year End 2021 Financial Results and Highlights Recent Activity (PRNewswire) - "IMU-935 phase 1 trial in mCRPC: Initial clinical safety data from the open-label phase 1 dose escalation trial are expected to be available in the third quarter of 2022."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Immunic, Inc. Reports Year End 2021 Financial Results and Highlights Recent Activity (PRNewswire) - "Vidofludimus calcium in UC: Top-line data of the induction phase of the phase 2 CALDOSE-1 trial in patients with moderate-to-severe UC are expected to be available in June of 2022....IMU-935 phase 1 program in psoriasis patients:...Initial results from this third portion of the phase 1 clinical trial are now expected to be available in the second half of 2022, instead of at the end of the second quarter of 2022....IMU-856 phase 1 program:...Unblinded safety data from the SAD and MAD...expected to be available in the third quarter of 2022. Initiation of the third portion of the phase 1 clinical trial in patients with intestinal barrier function associated diseases is expected in the first half of 2022.... A$4.7 million increase in external development costs related to the phase 2 clinical trial of vidofludimus calcium in ulcerative colitis"

Commercial • P1 data • P2 data • Trial status • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

Immunic Receives Notice of Allowance for Composition-of-Matter Patents in the United States and in Europe for IMU-935, a Potentially Best-in-Class Oral IL-17 Inhibitor (Yahoo News) - "Immunic, Inc...today announced that the company received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application 16/644581...The company also received notice of allowance of patent application EP18762111.5 in Europe, and notice of grant of patent application 2018330633 in Australia. All three patents cover composition-of-matter of IMU-935 and related formulations, and are expected to provide protection into at least 2038"

Patent • Immunology • Psoriasis • Rare Diseases

IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: Immunic AG; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CTCs

Immunic, Inc. Publishes Positive Results from the Single and Multiple Ascending Dose Parts of its Phase 1 Clinical Trial of IMU-935, a Potentially Best-in-Class Oral IL-17 Inhibitor (PRNewswire) - P1, N=NA; "Unblinded Data Established a Favorable Safety and Tolerability Profile for IMU-935 in Single Dose and 14-Day Multiple Dose Assessments in Healthy Human Subjects; Single Daily Dosing up to 400 mg and Multiple Daily Dosing of 300 mg were Found to Be Safe and Well-Tolerated in Healthy Human Subjects (With No Maximum Tolerated Dose Established) and the Investigated Doses are Believed to be Well Within the Potential Therapeutic Window of IMU-935...PK parameters in steady-state revealed a Tmax of 2.4 to 2.8 hours post-dose, a plasma half-life of 29 to 38 hours and dose proportional increases in Cmax and AUC...'We look forward to reporting initial results from this Part C portion in psoriasis patients in the second quarter of 2022.'"

P1 data • PK/PD data • Immunology • Psoriasis

Immunic, Inc. Announces Enrollment of the First Patient in its Phase 1 Trial of IMU-935 in Metastatic Castration-Resistant Prostate Cancer (PRNewswire) - "Immunic...announced enrollment of the first patient in its open-label phase 1 trial of IMU-935, a highly potent and selective inverse agonist of the transcription factor RORγt, in metastatic castration-resistant prostate cancer (mCRPC)....A total of between 18 and 24 patients are planned to be enrolled in the dose-escalation part at three dose levels of IMU-935 to be given for three cycles of 28 days each....Initial clinical data is expected to be available in the third quarter of 2022."

P1 data • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1; N=42; Not yet recruiting; Sponsor: Immunic AG

Clinical • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CTCs

Immunic, Inc. Reports Third Quarter 2021 Financial Results and Highlights Recent Activity (PRNewswire) - "Anticipated Clinical Milestones: The experimental phase of the multiple ascending dose (MAD) part of the phase 1 trial of IMU-935 has recently been completed. Unblinded safety, pharmacodynamic and pharmacokinetic (PK) data from the single ascending dose (SAD) and MAD parts in healthy volunteers is expected to be available in the fourth quarter of 2021....Research and Development (R&D) Expenses were $15.5 million for the three months ended September 30, 2021, as compared to $11.0 million for the same period ended September 30, 2020. The $4.4 million increase reflects...a $0.8 million increase in external development costs related to the phase 2 clinical trial of IMU-838 in UC, (iv) a $1.1 million increase in external development costs related to the phase 1 clinical trial of IMU-935..."

Commercial • P1 data • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

Immunic, Inc. Reports Third Quarter 2021 Financial Results and Highlights Recent Activity (PRNewswire) - "IMU-935 phase 1 trial in CRPC: An open-label phase 1 dose escalation trial designed to establish a potential recommended phase 2 dose and to assess safety, tolerability, anti-tumor activity, biomarkers and PK of IMU-935 in patients with progressive mCRPC, is expected to commence in the fourth quarter of 2021."

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer

Immunic, Inc. Announces First Psoriasis Patient Enrolled in Ongoing Phase 1 Trial of IMU-935 (PRNewswire) - "Immunic, Inc...announced enrollment of the first psoriasis patient in Part C of its ongoing phase 1 clinical trial of IMU-935, a highly potent and selective inverse agonist of the transcription factor RORγt...More than 10 sites in Australia and New Zealand are expected to participate in Part C....We also eagerly await completion of the single and multiple ascending dose parts of this phase 1 trial in healthy volunteers later in 2021..."

Enrollment status • Immunology • Psoriasis

IMU-935: Data from SAD/MAD parts of P1 trial for moderate to severe psoriasis in Q4 2021 (Immunic Therapeutics, 23rd Annual H.C. Wainwright Global Investment Conference 2021 (Virtual Meeting))

P1 data • Psoriasis

IMU-935: Data from SAD/MAD parts of P1 trial for moderate to severe psoriasis in Q4 2021 (Immunic Therapeutics, 23rd Annual H.C. Wainwright Global Investment Conference 2021 (Virtual Meeting))

P1 data • Psoriasis

[VIRTUAL] First clinical experience with IMU-935, an orally available small molecule inhibitor of IL-17 (ESDR 2021) - "IMU-935 is safe and well tolerated with a benign adverse event profile up to 400 mg as a single dose. Ongoing recruitment will provide intitial data on the anti-psoriasis activity of IMU-935"

Clinical • Constipation • Dermatology • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Immunology • Pain • Psoriasis • IL17A

Immunic, Inc. Reports Second Quarter 2021 Financial Results and Highlights Recent Activity (PRNewswire) - "IMU-838 in UC: Recruitment of the phase 2 CALDOSE-1 trial of IMU-838 in patients with UC is expected to be completed in the second half of 2021 and top-line data of the induction phase is expected to be available in the first half of 2022...IMU-935 phase 1 program in healthy volunteers and psoriasis patients:...Unblinded safety, pharmacodynamic and PK data from the SAD and MAD parts...expected to be available in the second half of 2021. Initiation of the third portion of the phase 1 trial in patients with moderate-to-severe psoriasis is expected in the third quarter of 2021 and initial human data from this patient population is expected to be available in the second quarter of 2022...Research and Development (R&D) Expenses were $15.7 million for the three months ended June 30, 2021...The increases were partially offset by a decrease of $2.3 million related to drug supply costs for IMU-838, IMU-935 and IMU-856."

Commercial • Enrollment status • P1 data • P2 data • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

Immunic, Inc. Reports Second Quarter 2021 Financial Results and Highlights Recent Activity (PRNewswire) - "IMU-935 phase 1 trial in CRPC patients: An open-label phase 1 dose escalation trial designed to establish a potential recommended phase 2 dose and to assess safety, tolerability, anti-tumor activity, biomarkers and PK of IMU-935 in patients with progressive mCRPC, is expected to commence in the fourth quarter of 2021."

New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer