Summary of Immunic (IMUX) Conference Call Company Overview - **Company**: Immunic (IMUX) - **Focus**: Clinical stage company developing oral treatments for chronic inflammation and autoimmune diseases, particularly multiple sclerosis (MS) [2][3] Key Points on Multiple Sclerosis (MS) Treatment - **Market Opportunity**: Immunic targets a significant commercial opportunity with peak sales potential estimated between $3 billion to $7 billion across various forms of MS [3][9] - **Pipeline**: - **Beta Frutimous Calcium**: In phase three for relapsing MS (RMS) and recently completed phase two for progressive MS (PMS) [3][9] - **IMU 856**: Targeting gastrointestinal diseases, specifically celiac disease [4][26] Beta Frutimous Calcium - **Mechanism of Action**: - Acts as a potent inhibitor of DHODH, reducing inflammation and preventing neurodegeneration [4][5] - Activates NurOwn, a nuclear receptor that protects neurons from cell death [5][10] - **Clinical Data**: - Phase two study (EMPHASIS) showed a 76% reduction in active lesions and a 94.2% rate of patients free from confirmed disability worsening after two years [12][13] - Phase two study (CALIPER) demonstrated a 24% reduction in confirmed disability worsening overall, with 33% in primary progressive MS (PPMS) patients [19][20] - Notably effective in patients without active inflammation, showing a 34% reduction in disability worsening [22][24] Unmet Medical Need - **Current Treatments**: Only one drug approved for primary progressive MS, highlighting a significant unmet need in the market [16][15] - **Patient Population**: Approximately 1.2 million eligible patients for MS treatment globally, with many not currently receiving therapy [8][16] Key Points on IMU 856 - **Mechanism**: A selective modulator targeting epithelial regeneration in the gut, potentially applicable to various gastrointestinal disorders [26][28] - **Clinical Data**: - Phase one study showed a significant increase in GLP-1 levels (up to 250%) in celiac disease patients, indicating potential for managing weight gain and gut health [31][32] - Demonstrated protection of gut villi and improved nutrient absorption in a short-term study [35][36] Safety and Tolerability - **Beta Frutimous Calcium**: Favorable safety profile with no new safety findings reported, making it an attractive option for newly diagnosed MS patients [23][14] - **IMU 856**: Safety and tolerability assessed in clinical studies, with promising results [30][34] Future Outlook - **Next Steps**: Anticipation of top-line data from phase three studies by the end of 2026, with potential NDA submission in 2027 if results are positive [25][37] - **Market Positioning**: Immunic aims to position Beta Frutimous Calcium as a unique oral treatment option for all forms of MS, addressing both relapsing and progressive forms [37]

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Core Insights - Immunic, Inc. has completed enrollment for both Phase 3 ENSURE trials of vidofludimus calcium in patients with relapsing multiple sclerosis (RMS), with top-line data expected by the end of 2026 [1][3] - Additional data from the Phase 2 CALLIPER trial in progressive multiple sclerosis (PMS) supports the positive results previously released, highlighting the neuroprotective potential of vidofludimus calcium [1][4] Group 1: ENSURE Trials - The ENSURE program consists of two identical multicenter, randomized, double-blind Phase 3 trials aimed at evaluating the efficacy, safety, and tolerability of vidofludimus calcium versus placebo in RMS patients [2] - A total of 1,121 patients were enrolled in ENSURE-1 and 1,100 patients in ENSURE-2, with the primary endpoint being the time to first relapse over 72 weeks [2] - Secondary endpoints include time to confirmed disability worsening, volume of new T2 lesions, and MRI-based endpoints [2] Group 2: CALLIPER Trial Data - In the Phase 2 CALLIPER trial, vidofludimus calcium demonstrated a 24% reduction in the hazard ratio for 24-week confirmed disability worsening (24wCDW) compared to placebo [5] - The drug showed a 33% reduction in 24wCDW in primary progressive multiple sclerosis (PPMS) patients, a 19% reduction in non-active secondary progressive multiple sclerosis (naSPMS), and a 34% reduction in active secondary progressive multiple sclerosis (aSPMS) [5] - For patients without evidence of gadolinium-enhancing lesions at baseline, vidofludimus calcium reduced 24wCDW by 34% compared to placebo [5][6] Group 3: Vidofludimus Calcium Overview - Vidofludimus calcium is an investigational oral small molecule drug targeting chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis [7] - The drug acts as a selective immune modulator, activating the neuroprotective transcription factor Nurr1 and inhibiting dihydroorotate dehydrogenase (DHODH) to provide neuroprotective, anti-inflammatory, and anti-viral effects [7] - The drug has been tested in approximately 2,700 individuals, showing an attractive pharmacokinetic, safety, and tolerability profile [7]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content delivered includes insights across sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Viewpoint - Immunic, Inc. has successfully closed an underwritten public offering, raising approximately $65 million, with potential additional proceeds of up to $130 million from the exercise of warrants [1][3]. Group 1: Offering Details - The offering included pre-funded warrants, Series A warrants, and Series B warrants, with the Pre-Funded Warrants being immediately exercisable [1][2]. - Series A Warrants can be exercised until December 31, 2025, while Series B Warrants can be exercised starting October 1, 2025, until June 3, 2030 [2]. - The Series A and B Warrants will expire proportionally if the corresponding Pre-Funded Warrants are exercised before September 30, 2025 [2]. Group 2: Financial Aspects - The initial proceeds from the offering were approximately $65 million, before deducting underwriting discounts and commissions [3]. - The company may receive up to an aggregate of $130 million in additional proceeds if the Series A and Series B Warrants are fully exercised for cash [3]. Group 3: Use of Proceeds - The net proceeds from the offering will be used to fund clinical trials, operations, and other general corporate purposes [5]. Group 4: Company Overview - Immunic, Inc. is focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases [6]. - The lead development program, vidofludimus calcium (IMU-838), is in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026 [6]. - Other programs include IMU-856, targeting gastrointestinal diseases, and IMU-381, which is in preclinical testing [6].

Core Viewpoint - Immunic, Inc. is actively participating in several investor and scientific conferences in June 2025 to present its clinical pipeline and engage with investors [1][3]. Conference Participation - Immunic will present at the Jefferies Healthcare Conference from June 3-5, with CEO Daniel Vitt providing a company overview on June 5 at 4:55 pm ET [1]. - The company will also participate in the 4th RSC Anglo-Nordic Medicinal Chemistry Symposium from June 10-13, where preclinical data on antiviral candidates will be presented [1][3]. - Attendance at the UBS Life Sciences Conference in London is scheduled for June 11, with opportunities for one-on-one meetings [1]. - Immunic's management will engage in partnering activities at the BIO International Convention from June 16-19 in Boston [1]. - The 11th Congress of the European Academy of Neurology will take place from June 21-24 in Helsinki, where data on vidofludimus calcium will be presented [1][3]. - The Accelerating Bio-Innovation Conference will be attended by Dr. Vitt and Mr. Tardio from June 23-25 in Cambridge, MA [1]. Company Overview - Immunic, Inc. focuses on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases [3]. - The lead program, vidofludimus calcium (IMU-838), is in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026 [4]. - Vidofludimus calcium acts as a first-in-class nuclear receptor related 1 (Nurr1) activator, providing neuroprotective effects and anti-inflammatory properties [4]. - Other candidates include IMU-856, targeting Sirtuin 6 (SIRT6) for gastrointestinal diseases, and IMU-381, currently in preclinical testing [4].

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Viewpoint - Immunic, Inc. has announced a public offering of pre-funded warrants and series A and B warrants, aiming to raise approximately $65 million initially, with potential total gross proceeds of up to $130 million if all warrants are exercised [1][3]. Group 1: Offering Details - The public offering price for one Pre-Funded Warrant, one Series A Warrant, and one Series B Warrant is set at $0.7499 [1]. - The Pre-Funded Warrants are immediately exercisable, while Series A Warrants can be exercised until December 31, 2025, and Series B Warrants can be exercised starting October 1, 2025, for a period of five years [1]. - The offering is expected to close around June 3, 2025, pending customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to fund clinical trials, operations, and other general corporate purposes [4]. Group 3: Company Overview - Immunic, Inc. is focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases, with its lead program, vidofludimus calcium (IMU-838), currently in phase 3 trials for relapsing multiple sclerosis [7]. - Vidofludimus calcium has shown therapeutic activity in earlier trials and combines neuroprotective effects with anti-inflammatory properties [7]. - The company is also developing IMU-856 for gastrointestinal diseases and IMU-381, which is in preclinical testing [7].

Core Viewpoint - Immunic, Inc. has initiated an underwritten public offering of various warrants to purchase shares of common stock, aimed at funding clinical trials and operations for its pipeline of therapies targeting chronic inflammatory and autoimmune diseases [1][2]. Group 1: Offering Details - The public offering includes pre-funded warrants, Series A warrants expiring on December 31, 2025, and Series B warrants expiring five years after issuance [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1]. - Leerink Partners is acting as the sole bookrunner for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to fund clinical trials, operations, and other general corporate purposes [2]. Group 3: Company Overview - Immunic, Inc. is focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases [5]. - The lead program, vidofludimus calcium (IMU-838), is in phase 3 trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026 [5]. - Vidofludimus calcium has shown therapeutic activity in earlier phase 2 trials and works as a first-in-class nuclear receptor related 1 (Nurr1) activator [5]. - Other candidates include IMU-856, targeting gastrointestinal diseases, and IMU-381, currently in preclinical testing [5].

Financial Position - Immunic, Inc. reported an accumulated deficit of approximately $536.9 million as of March 31, 2025, up from $511.4 million as of December 31, 2024[152]. - As of March 31, 2025, Immunic had cash and cash equivalents of approximately $14.3 million, which is insufficient to fund operations for at least twelve months without raising additional capital[153]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[162]. - Cash and cash equivalents were approximately $14.3 million as of March 31, 2025, indicating inadequate liquidity to fund operations for at least twelve months without raising additional capital[181]. - As of March 31, 2025, the Company had approximately $14.3 million in cash and cash equivalents[199]. - The Company filed a shelf registration statement in November 2023 allowing for the offering of up to $250 million in various securities, with a total shelf availability of approximately $412.3 million as of March 31, 2025[184]. - The Company incurred no cash from financing activities for the three months ended March 31, 2025, compared to $74.4 million in the same period of the previous year[205][206]. Clinical Trials and Product Development - The Phase 3 ENSURE program for vidofludimus calcium in relapsing multiple sclerosis (RMS) is ongoing, with completion expected in the second quarter of 2026[139]. - Positive interim data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) showed substantial reductions in disability progression and thalamic brain volume[140]. - IMU-856 demonstrated positive effects in a Phase 1b clinical trial for celiac disease, including protection of gut architecture and improvement of symptoms[144]. - The company is preparing for a Phase 2 clinical trial of IMU-856 in patients with ongoing active celiac disease[144]. - Immunic is focused on executing ongoing clinical trials and exploring additional indications for its product candidates[150]. - Vidofludimus calcium reduced the relative risk of 24-week confirmed disability worsening by 30% in primary progressive multiple sclerosis patients compared to placebo[156]. - IMU-856 demonstrated a dose-dependent increase of endogenous GLP-1 levels in celiac disease patients, with significant increases of 80 mg (p=0.014) and 160 mg (p=0.003) compared to placebo[155]. Financial Performance - The company incurred a net loss of $25.5 million for the three months ended March 31, 2025, a decrease of 14% compared to a net loss of $29.6 million for the same period in 2024[173]. - Research and development expenses increased by $2.8 million (15%) to $21.5 million for the three months ended March 31, 2025, compared to $18.7 million for the same period in 2024[173][174]. - The total operating expenses for the three months ended March 31, 2025, were $26.8 million, an increase of 12% from $23.9 million in the same period in 2024[173]. - Interest income decreased by $1.0 million (85%) to $183,000 for the three months ended March 31, 2025, compared to $1.2 million for the same period in 2024[173][175]. - For the three months ended March 31, 2025, operating activities used $21.8 million in cash, primarily due to a net loss of $25.5 million[201]. Strategic Plans and Collaborations - Immunic plans to evaluate potential strategic collaborations to enhance the commercialization of its product candidates[151]. - The Company expects future expenses to increase as it continues research, development, and clinical trials for its product candidates[196]. - The Company has non-cancelable contractual obligations totaling approximately $2.6 million related to its development programs, expected to be paid in 2025 and 2026[210]. Currency and Inflation Risks - The company has significant exposure to foreign currency exchange rates, primarily the Euro and the Australian dollar, which could adversely affect financial results[214]. - A 10% change in currency exchange rates could materially impact the company's financial position, with a potential effect of approximately $1.3 million on net current liabilities as of March 31, 2025[216]. - For the three months ended March 31, 2025, a 10% change in foreign currency exchange rates would have impacted the company's net loss by approximately $2.0 million, primarily due to the Euro[216]. - The company has not entered into any foreign currency hedging transactions and does not have current plans to do so[214]. - The company has experienced a general increase in costs due to global inflation, but does not believe it has had a material impact on operations[217]. - The company’s German subsidiary is a significant portion of its business, and fluctuations in exchange rates could affect its consolidated financial position[215]. Accounting and Disclosure - The company has adopted ASU No. 2023-09 for income tax disclosures, effective January 1, 2025, which will improve the consistency and disaggregation of information[212]. - The company evaluates its accounting estimates and assumptions on an ongoing basis, which may differ from actual results under different conditions[211].