Immunic(IMUX)

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Immunic (IMUX) Investor Presentation - Slideshow
2021-08-13 14:22
IMMUNIC THERAPEUTICS Immunic Therapeutics Developing Selective Oral Drugs in Immunology NASDAQ: IMUX | August 2021 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 Exchange Act of 1934, as amended. These include statements regarding management's intentions, pl ...
Immunic(IMUX) - 2021 Q2 - Quarterly Report
2021-08-06 12:26
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Delaware 56-2358443 (State or other jurisdiction of (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36201 incorporation or organization) (I.R.S. Employer Identification No.) Im ...
Immunic (IMUX) Updates On The Preclinical And Clinical Development Of IMU-935 - Slideshow
2021-07-16 19:06
| --- | --- | --- | --- | |-------|-------|-------|-------| | | | | | | | | | | | | | | | 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 Exchange Act of 1934, as amended. These include statements regarding management's intentions, plans, beliefs, expectation ...
Immunic(IMUX) - 2021 Q1 - Quarterly Report
2021-05-06 12:09
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36201 Immunic, Inc. (Exact name of registrant as specified in its charter) Delaware 56-2358443 (State or other jurisdiction of ...
Immunic (IMUX) Investor Presentation - Slideshow
2021-03-15 21:03
IMMUNIC THERAPEUTICS Immunic Therapeutics Developing Selective Oral Drugs in Immunology NASDAQ: IMUX | March 2021 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 Exchange Act of 1934, as amended. These include statements regarding management's intentions, pla ...
Immunic(IMUX) - 2020 Q4 - Annual Report
2021-02-26 12:20
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36201 Immunic, Inc. (Exact name of registrant as specified in its charter) Delaware 56-2358443 (State or other jurisdiction of incor ...
Immunic(IMUX) - 2020 Q3 - Quarterly Report
2020-11-06 12:23
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36201 Immunic, Inc. (Exact name of registrant as specified in its charter) Delaware 56-2358443 (State or other jurisdiction ...
Immunic (IMUX) Investor Presentation - Slideshow
2020-10-31 00:10
IMMUNIC THERAPEUTICS Immunic Therapeutics Developing Selective Oral Drugs in Immunology NASDAQ: IMUX | October 2020 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 Exchange Act of 1934, as amended. These include statements regarding management's intentions, p ...
Immunic(IMUX) - 2020 Q2 - Earnings Call Transcript
2020-08-03 18:58
Financial Data and Key Metrics Changes - Immunic reported positive top-line data from the Phase 2 EMPhASIS trial of IMU-838 for relapsing-remitting multiple sclerosis, indicating a significant clinical advancement for the company [6][10] - The primary endpoint analysis showed that treatment with 45 mg of IMU-838 suppressed an average of 62% of cumulative unique active (CUA) MRI lesions compared to placebo, with a p-value of 0.0002 [21] - The 30 mg dose of IMU-838 demonstrated a 70% suppression of CUA MRI lesions over 24 weeks compared to placebo, with a p-value of less than 0.0001 [22] Business Line Data and Key Metrics Changes - IMU-838 is currently being tested in multiple clinical trials, including those for ulcerative colitis and COVID-19, showcasing its broad therapeutic potential [11] - The trial included a total of 209 patients, with 197 completing the 24-week blinded treatment period, indicating strong patient retention [18] Market Data and Key Metrics Changes - The global market for multiple sclerosis treatments was approximately $22 billion in 2016, with a significant need for effective oral therapies [13] - The company aims to address the unmet medical need for oral medications that balance safety, tolerability, and convenience for MS patients [14] Company Strategy and Development Direction - Immunic is focusing on developing IMU-838 as a once-daily oral medication for relapsing-remitting MS, emphasizing its favorable safety profile and potential for high patient compliance [14][42] - The company is preparing for a potential Phase 3 program based on the positive Phase 2 data, with plans to engage with regulatory authorities for guidance [41][90] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the compelling clinical activity of IMU-838 and its unique safety properties compared to current treatment options [42] - The company is accelerating preparations for Phase 3 testing, indicating confidence in the drug's potential [41] Other Important Information - The trial reported low rates of treatment-emergent adverse events, with only three serious adverse events noted, highlighting the favorable safety profile of IMU-838 [28][39] - No signals for hepatotoxicity were observed in the IMU-838 development program, differentiating it from other MS treatments [32][39] Q&A Session Summary Question: Expected relapse data with two years of treatment based on 24-week results - Management anticipates a more than 30% relapse reduction rate based on the correlation from meta-analysis, pending confirmation in a larger Phase 3 program [46] Question: Initial thoughts on Phase 3 program design - The company plans to follow regulatory guidance and may include a head-to-head trial with an active comparator [49][50] Question: Additional data expected at the September presentation - More detailed safety data and potential signals on EDSS disability progression and brain atrophy data are anticipated [51] Question: Incidence of diarrhea and alopecia rates in the trial - Initial monitoring indicates extremely low incidence rates for these adverse events, with no significant safety concerns expected [56] Question: PML risk with Aubagio and its relevance to IMU-838 - Current understanding suggests that teriflunomide (Aubagio) carries low PML risk, and similar expectations are held for IMU-838 based on its antiviral properties [60] Question: Typical MS patient population in clinical trials - The patient population reflects a shift towards regions with fewer medical resources, which is common in MS clinical trials [61] Question: Effects on total lesion or MRI activity if assessed at 36 weeks - Management believes that longer durations may help with data variability but does not expect a significant change in lesion suppression proportions [66] Question: Additional data needed to prevent a potential black box warning - More patient data showing no acute liver failure cases would be beneficial to alleviate regulatory concerns [68] Question: Curve separation in the study - Separation of treatment arms versus placebo was observed as early as week 6, consistent with other drugs in the category [77] Question: Decision on which dose to carry forward into Phase 3 - No final decision has been made yet, but both doses showed equal efficacy and safety [79] Question: Potential comparators for Phase 3 trials - Comparators will likely include established oral options, but specific details are not yet available [80] Question: Plans for Phase 3 development with potential partners - The company is open to various options, including partnerships, based on the positive data [82] Question: Efficacy at 12 weeks and consistency with previous data - A numerical difference between treatment arms was observed at 12 weeks, but formal statistical analysis was not conducted [100]
Immunic(IMUX) - 2020 Q2 - Quarterly Report
2020-08-03 12:23
Commission File Number: 001-36201 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Immunic, Inc. (Exact name of registrant as specified in its charter) Delaware 56-2358443 (State or other jurisdiction of i ...