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Immunic(IMUX) - 2022 Q2 - Earnings Call Transcript
2022-08-06 17:32
Immunic, Inc. (NASDAQ:IMUX) Q2 2022 Earnings Conference Call August 4, 2022 8:00 AM ET Company Participants Jessica Breu - Head, Investor Relations and Communications Daniel Vitt - Chief Executive Officer and President Glenn Whaley - Chief Financial Officer Hella Kohlhof - Chief Scientific Officer Conference Call Participants Andreas Argyrides - Wedbush Yasmeen Rahimi - Piper Sandler Matt Kaplan - Ladenburg Michael Kratky - SVB Securities Jessica Breu Good morning, everybody and welcome to Immunic’s Second ...
Immunic(IMUX) - 2022 Q2 - Earnings Call Presentation
2022-08-06 17:31
lmmunic THERAPEUTICS Immunic Therapeutics Second Quarter 2022 Financial Results and Corporate Update NASDAQ: IMUX | August 4, 2022 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' ...
Immunic(IMUX) - 2022 Q2 - Quarterly Report
2022-08-04 11:01
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, 2022 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 i ...
Immunic(IMUX) - 2022 Q1 - Earnings Call Presentation
2022-05-11 13:41
IMMUNIC THERAPEUTICS Immunic Therapeutics First Quarter 2022 Financial Results and Corporate Update NASDAQ: IMUX | May 10, 2022 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 i ...
Immunic(IMUX) - 2022 Q1 - Earnings Call Transcript
2022-05-10 14:54
Immunic Inc. (NASDAQ:IMUX) Q1 2022 Earnings Conference Call May 10, 2022 8:00 AM ET Company Participants Daniel Vitt – Chief Executive officer, President & Director Glenn Whaley – Vice President of Finance and Principal Financial & Accounting Officer Conference Call Participants Thomas Smith – SVB Leerink Yasmeen Rahimi – Piper Sandler Andreas Argyrides – Wedbush Matthew Kaplan – Lautenbach Tallmann Boobalan Pachaiyappan – H.C. Wainwright Zegbeh Jallah – Roth Capital Operator Good morning and welcome to Imm ...
Immunic(IMUX) - 2022 Q1 - Quarterly Report
2022-05-10 10:38
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, 2022 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) - 2021 Q4 - Earnings Call Transcript
2022-02-24 18:51
Financial Data and Key Metrics Changes - The company ended 2021 with $86.9 million in cash and cash equivalents, having raised an additional $16.2 million in 2022, which is expected to fund operations through Q1 2023 [17] - Research and development expenses increased to $61.1 million in 2021 from $38.6 million in 2020, reflecting the ramp-up of clinical expenses and increased personnel costs [17][18] - General administrative expenses rose to $13.3 million in 2021 from $10.3 million in 2020, primarily due to non-cash stock compensation [19] - The net loss for 2021 was approximately $92.9 million, or $3.93 per share, compared to a net loss of approximately $44 million, or $2.81 per share, in 2020 [19] Business Line Data and Key Metrics Changes - The company achieved significant clinical progress in its pipeline, including the enrollment of the first patient in the Phase III ENSURE program and completion of enrollment in the Phase II CALDOSE-1 trial [5][9] - Positive unblinded safety, pharmacokinetics (PK), and pharmacodynamics (PD) data were reported for IMU-935 from the Phase 1 trial [5][10] - The Phase II CALLIPER trial enrolled a total of 263 patients, with top-line results expected in June 2022 [8][20] Market Data and Key Metrics Changes - The global multiple sclerosis (MS) market exceeds $23 billion, with the company positioned to address unmet needs in MS treatment [10] - The company is exploring the therapeutic potential of IMU-935 in castration-resistant prostate cancer (CRPC) and has initiated a Phase 1b trial [10][11] Company Strategy and Development Direction - The company aims to realize the full potential of its clinical programs, with a focus on key therapeutic areas [7] - The appointment of a Chief Business Officer indicates a strategic move to enhance business development efforts [7] - The company is considering expanding clinical trials to additional countries to expedite patient enrollment [7][34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming milestones in 2022, including the readout of the Phase II CALDOSE-1 trial and initial results from the Phase 1 trial of IMU-935 [20][21] - The management highlighted the importance of the baseline data in the CALDOSE-1 trial, which is expected to limit placebo response and enhance the drug's chance of showing efficacy [24][25] Other Important Information - The company has strengthened its intellectual property position with patents covering IMU-935, providing protection until at least 2038 [11][12] - The company has implemented measures to monitor the impact of the ongoing conflict in Ukraine on its clinical trials, ensuring that the CALDOSE study remains unaffected [55][56] Q&A Session Summary Question: What are the expected remission rates in the CALDOSE-1 trial? - Management expressed confidence in the baseline data, indicating a high activity level in the patient population, which should limit placebo response [23][24] Question: Will there be a Phase 3 trial for IMU-838, and will it be conducted independently or with a partner? - Management stated that it is too early to determine the structure of a Phase 3 trial, but discussions with medical advisors are ongoing [26] Question: Can you provide insights on the emphasis trial results and neurofilament concentrations? - Management noted that the emphasis trial results confirm the dosing strategy and suggest potential neuroprotective effects of IMU-838 [32][33] Question: What is the enrollment speed for the MS studies? - Management reported good enrollment progress across all MS studies, with no significant delays [40] Question: How does EBV relate to MS and the company's drug development? - Management highlighted recent studies linking EBV to MS onset and discussed the potential role of IMU-838 in addressing EBV-related issues [41][42]
Immunic(IMUX) - 2021 Q4 - Earnings Call Presentation
2022-02-24 17:56
Immunic THERAPEUTICS Immunic Therapeutics Fourth Quarter and Year-End 2021 Financial Results and Corporate Update NASDAQ: IMUX | February 24, 2022 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 regar ...
Immunic(IMUX) - 2021 Q4 - Annual Report
2022-02-24 12:07
FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the fiscal year ended December 31, 2021 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 ot ...
Immunic(IMUX) - 2021 Q3 - Earnings Call Transcript
2021-11-06 20:39
Immunic, Inc. (NASDAQ:IMUX) Q3 Results Earnings Conference Call November 4, 2021 8:00 AM ET Company Participants Jessica Breu - Head of IR & Communications Daniel Vitt - CEO, President & Director Glenn Whaley - VP of Finance and Principal Financial & Accounting Officer Andreas Muehler - Chief Medical Officer Patrick Walsh - Chief Business Officer Inderpal Singh - General Counsel Conference Call Participants Yasmeen Rahimi - Piper Sandler Gobind Singh - JMP Securities Michael Kratky - SVB Leerink Matthe ...