Dose Escalation Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Single Agent IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer

Dose escalation study to evaluate the safety, tolerability and anti-tumor activity of single agent IMU-935 in patients with progressive, metastatic castration resistant prostate cancer (mCRPC).

Start Date09 Dec 2021

Sponsor / Collaborator

Immunic AG

ACTRN12619001544167 / CompletedPhase 1

A three-part, double-blind, placebo-controlled, phase I/Ib study of the safety, tolerability and pharmacokinetics of single and multiple ascending doses of IMU-935 in healthy volunteers and Psoriasis Patients.

Start Date17 Sep 2019

Sponsor / Collaborator

Avance Clinical Pty Ltd.Startup

100 Clinical Results associated with Izumerogant

100 Translational Medicine associated with Izumerogant

100 Patents (Medical) associated with Izumerogant

Literatures (Medical) associated with Izumerogant

01 Nov 2024·Antiviral Research

Orally bioavailable RORγ/DHODH dual host-targeting small molecules with broad-spectrum antiviral activity

Article

Author: Weil, Tatjana ; Grunwald, Thomas ; Klopfleisch, Robert ; Heinen, Natalie ; Reuter, Sebastian ; Dobner, Thomas ; Sparrer, Konstantin M.J. ; Herrmann, Alexandra ; Irrgang, Pascal ; Hahn, Friedrich ; Münch, Jan ; Wagner, Sabrina ; Eberlein, Valentina ; Cordsmeier, Arne ; Ip, Wing-Hang ; Groß, Rüdiger ; Gege, Christian ; Tenbusch, Matthias ; Kohlhof, Hella ; Cynis, Holger ; Pfaender, Stephanie ; Uhlig, Nadja ; Kögler, Melanie ; Hietel, Benjamin ; Issmail, Leila ; Sparrer, Konstantin M J ; Wangen, Christina ; Hunszinger, Victoria ; Vitt, Daniel ; Ensser, Armin

Host-directed antivirals (HDAs) represent an attractive treatment option and a strategy for pandemic preparedness, especially due to their potential broad-spectrum antiviral activity and high barrier to resistance development. Particularly, dual-targeting HDAs offer a promising approach for antiviral therapy by simultaneously disrupting multiple pathways essential for viral replication. Izumerogant (IMU-935) targets two host proteins, (i) the retinoic acid receptor-related orphan receptor γ isoform 1 (RORγ1), which modulates cellular cholesterol metabolism, and (ii) the enzyme dihydroorotate dehydrogenase (DHODH), which is involved in de novo pyrimidine synthesis. Here, we synthesized optimized derivatives of izumerogant and characterized their antiviral activity in comparison to a recently described structurally distinct RORγ/DHODH dual inhibitor. Cell culture-based infection models for enveloped and non-enveloped DNA and RNA viruses, as well as a retrovirus, demonstrated high potency and broad-spectrum activity against human viral pathogens for RORγ/DHODH dual inhibitors at nanomolar concentrations. Comparative analyses with equipotent single-target inhibitors in metabolite supplementation approaches revealed that the dual-targeting mode represents the mechanistic basis for the potent antiviral activity. For SARS-CoV-2, an optimized dual inhibitor completely blocked viral replication in human airway epithelial cells at 5 nM and displayed a synergistic drug interaction with the nucleoside analog molnupiravir. 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.

01 May 2023·Clinical Pharmacology in Drug Development

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

Article

Author: Fliegert, Frank ; Vitt, Daniel ; Polasek, Thomas M. ; Muehler, Andreas R. ; Betscheider, Irina ; Leelasena, Indika ; Kohlhof, Hella ; Marolt, Marija

AbstractRetinoic acid receptor–related orphan nuclear receptor (ROR)γt regulates the transcription of interleukin‐17 and other cytokines implicated in inflammatory and autoimmune diseases. We assessed the safety, tolerability, and pharmacokinetics (PK) of IMU‐935, an inverse agonist of RORγt, in a first‐in‐human phase 1 study. This was a double‐blind, placebo‐controlled trial that randomly assigned healthy subjects single ascending doses (25–400 mg) or multiple ascending doses (150 mg once or twice daily for 14 days) of IMU‐935 or placebo. Dose escalation was determined by the safety, tolerability, and PK. Twenty‐four and 70 subjects received placebo or IMU‐935, respectively. Of the 70 subjects who received IMU‐935, 59 received a single dose and 11 received multiple doses. Treatment‐emergent adverse events (TEAEs) occurred in 21 subjects (88%) and 58 (83%) given any dose of placebo or IMU‐935, respectively. Treatment‐related TEAEs occurred in 6 (30%) and 25 (42%) subjects given a single dose of placebo and IMU‐935, respectively. All treatment‐related TEAEs were mild except for 2 moderate TEAEs and 1 moderate TEAE in the IMU‐935 group and placebo group, respectively. No treatment‐related discontinuations or serious adverse events occurred. 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.

02 Dec 2021·Expert Opinion on Drug DiscoveryQ3 · MEDICINE

Retinoic acid-related orphan receptor gamma t (RORγt) inverse agonists/antagonists for the treatment of inflammatory diseases – where are we presently?

Q3 · MEDICINE

Review

Author: Gege, Christian

Introduction: The transcription factor retinoic acid-related orphan receptor gamma t (RORγt) has been identified as the master regulator of T_H17 cell differentiation and IL-17/22 production and is therefore an attractive target for the treatment of inflammatory diseases. Several orally or topically administered small molecule RORγt inverse agonists (RIAs) have progressed up to the end of clinical Phase 2.Areas covered: Based on publications and patent evaluations this review summarizes the evolution of the chemical matter for all 16 pharmaceutical companies, who develop(ed) a clinical-stage RIAs (until March 2021). Structure proposals for some clinical stage RIAs are presented and the outcome of the clinical trials is discussed.Expert opinion: So far, the clinical trials have been plagued with a high attrition rate. Main reasons were lack of efficacy (topical) or safety signals (oral) as well as, amongst other things, thymic lymphomas as seen with BMS-986251 in a preclinical study and liver enzyme elevations in humans with VTP-43742. Possibilities to mitigate these risks could be the use of RIAs with different chemical structures not interfering with thymocytes maturation and no livertox-inducing properties. With new frontrunners (e.g., ABBV-157 (cedirogant), BI 730357 or IMU-935) this is still an exciting time for this treatment approach.

News (Medical) associated with Izumerogant

07 Nov 2024

·www.prnewswire.com

Immunic, Inc. Reports Third Quarter 2024 Financial Results and Provides Corporate Update

– Positive Interim Analysis of Phase 3 ENSURE Program, Unblinded Independent Data Monitoring Committee Confirmed that Predetermined Futility Criteria Have Not Been Met and Recommended Trials Should Continue as Planned – – Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain on Track – – Top-Line Data from Phase 2 CALLIPER Trial Expected in April 2025 – – Webcast to be Held Today, November 7, at 8:00 am ET – NEW YORK, Nov. 7, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced financial results for the third quarter and nine months ended September 30, 2024, and provided a corporate update. "During the third quarter, we have continued to advance both our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and our twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS), for our potentially transformative, orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838)," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "As recently reported, we are progressing, as planned, with our phase 3 ENSURE program in RMS, after an interim, non-binding futility analysis, conducted by an unblinded Independent Data Monitoring Committee (IDMC), recommended that the trials are not futile and should continue as planned, without any sample size increase, marking a key milestone for the program. We continue to expect to complete the ENSURE-1 trial in the second quarter of 2026 and the ENSURE-2 trial in the second half of 2026. Our next important clinical readout for this program is the CALLIPER top-line data in PMS, which we expect to release in April of next year. As previously reported, the CALLIPER interim data supported the potential effectiveness of vidofludimus calcium in slowing disease progression in PMS and further substantiated its neuroprotective capabilities through the activation of Nurr1. Should the top-line data continue to demonstrate this neuroprotective effect, and the phase 2 trial meets its primary and key secondary endpoints, we may be able to position vidofludimus calcium as the first oral treatment option for non-relapsing secondary progressive MS (SPMS)." "In September, we had the opportunity to present four posters at the prestigious 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), showcasing data on key aspects of vidofludimus calcium's profile. This included the neurofilament light chain (NfL) interim data from our phase 2 CALLIPER trial, which showed a clear separation from placebo in NfL levels across the PMS patient population, including non-relapsing SPMS, a subtype with the highest unmet medical need. We also presented antiviral data suggesting an effect on reducing fatigue, Nurr1 target data supporting the neuroprotective potential, and pathogenic T cell data further supporting the drug's anti-inflammatory effects. The presentations at ECTRIMS followed closely on the heels of our MS R&D Day, which featured two world renowned industry experts alongside Immunic's management team to discuss vidofludimus calcium's unique profile, including its safety and tolerability, and its potential to significantly elevate today's standard of care. We continue to believe that, if approved, vidofludimus calcium, with its combined neuroprotective, anti-inflammatory and anti-viral effects, would represent a unique new treatment option targeted to the complex pathophysiology of MS." Dr. Vitt continued, "During the quarter, we continued phase 2 clinical preparations for IMU-856, our orally available, systemically acting small molecule modulator targeting Sirtuin 6 (SIRT6), a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, including exploring potential financing, licensing or partnering opportunities to fund this clinical program. As we have noted previously, based on initial clinical proof-of-concept data, we believe that IMU-856 could be an entirely new therapeutic approach to treating gastrointestinal disorders by restoring a healthy gut through renewal of the bowel wall. Data from our phase 1b clinical trial showed that, in patients with celiac disease during periods of gluten-free diet and gluten challenge, IMU-856 demonstrated positive effects over placebo in four key dimensions of celiac disease pathophysiology: protection of the gut architecture, improvement of patients' symptoms, biomarker response, and enhancement of nutrient absorption. Based on this encouraging data, we are considering additional possible clinical applications in other gastrointestinal disorders." Third Quarter 2024 and Subsequent Highlights October 2024: Announced a positive outcome of the non-binding, interim futility analysis of the phase 3 ENSURE program of vidofludimus calcium for the treatment of RMS. An unblinded IDMC confirmed that the trials are not futile and recommended that they should continue without changes, including no need for a potential upsizing of the sample size. September 2024: Presented key data at the 40th Congress of ECTRIMS, highlighting vidofludimus calcium's therapeutic potential in MS, in one oral poster presentation and three ePosters. September 2024: Enrolled the first patient in an investigator-sponsored phase 2 clinical trial of vidofludimus calcium, entitled, "Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID_REVIVE)." September 2024: Hosted an MS R&D Day in New York, during which management was joined by two renowned experts in the field, Francesca Montarolo, Ph.D., Neuroscience Institute Cavalieri Ottolenghi (NICO) and University of Turin, Italy, and Amit Bar-Or, M.D., FRCPC, Perelman School of Medicine, University of Pennsylvania. The event focused on today's MS landscape and on vidofludimus calcium's potential to become the treatment of choice for both relapsing and progressive MS patients. July 2024: Announced the appointment of Simona Skerjanec, M.Pharm, MBA, a thought leader in brain health with decades of experience in drug development and commercialization, to the Board of Directors. July 2024: Announced the appointment of Jason Tardio, MBA, as Chief Operating Officer and President, to lead internal efforts in positioning the company for the potential launch of vidofludimus calcium and to work closely with Patrick Walsh, Chief Business Officer, to prepare for a range of potential partnership outcomes for vidofludimus calcium and Immunic's other drug candidates. Additionally, reported that Werner Gladdines, former Vice President, Program Management & Clinical Development Operations, was promoted to Chief Development Officer. Anticipated Clinical Milestones Vidofludimus calcium in MS: Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April 2025. Completion of ENSURE-1 is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected in the second half of 2026. IMU-856 in celiac disease: Based on the positive data from the phase 1b clinical trial, the company is preparing for clinical phase 2 testing of IMU-856, contingent on financing, licensing or partnering. Financial and Operating Results Research and Development (R&D) Expenses were $21.4 million for the three months ended September 30, 2024, as compared to $19.8 million for the three months ended September 30, 2023. The $1.6 million increase reflects (i) a $1.4 million increase in external development costs related to the vidofludimus calcium program, (ii) a $0.3 million increase in external development costs related to IMU-856, (iii) a $0.3 million increase in personnel costs due to an increase in headcount and (iv) a $0.3 million increase related costs across numerous categories. The increases were offset by a decrease of $0.7 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer. For the nine months ended September 30, 2024, R&D expenses were $58.4 million, as compared to $63.9 million for the nine months ended September 30, 2023. The $5.5 million decrease reflects (i) a decrease of $4.1 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer, (ii) a $2.6 million decrease in external development costs related to IMU-856 due to the completion of the phase 1 clinical trial in celiac disease and (iii) a $0.5 million decrease related costs across numerous categories. The decreases were offset by (i) a $1.2 million increase in personnel costs, $0.2 million of which is related to non-cash stock compensation and the remainder of which is due to an increase in headcount and (ii) a $0.5 million increase in external development costs related to the vidofludimus calcium program. General and Administrative (G&A) Expenses were $4.4 million for the three months ended September 30, 2024, as compared to $3.8 million for the same period ended September 30, 2023. The $0.6 million increase was primarily due to a $0.6 million increase in personnel expense in G&A, $0.2 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount. For the nine months ended September 30, 2024, G&A expenses were $14.0 million, as compared to $11.9 million for the same period ended September 30, 2023. The $2.1 million increase was primarily due to (i) a $1.7 million increase in personnel expense in G&A, $0.9 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount, (ii) $0.3 million in legal and consultancy expenses and (iii) a $0.1 million increase related to costs across numerous categories. Interest Income remained unchanged at $0.8 million during the three months ended September 30, 2024, as compared to the three months ended September 30, 2023. Interest income for the nine months ended September 30, 2024 was $2.9 million, as compared to $2.5 million for the nine months ended September 30, 2023. The $0.4 million increase was due to higher interest rates. The Change in Fair Value of the Tranche Rights of $4.8 million for the nine months ended September 30, 2024 was a non-cash charge related to the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially classified as a liability, but were reclassified to equity on March 4, 2024, when stockholders approved the increase in authorized shares from 130 million to 500 million shares of common stock and therefore the tranche 2 and tranche 3 rights needed to be revalued to fair value upon the reclass to equity. Other Income (Expense) was $0.6 million for the three months ended September 30, 2024, as compared to $35 thousand for the same period ended September 30, 2023. The $0.5 million increase was primarily attributable to a $0.6 million increase in R&D tax incentives for clinical trials in Australia. For the nine months ended September 30, 2024, other income (expense) was ($1.1 million), as compared to $1.3 million for the same period ending September 30, 2023. The $2.4 million decrease was primarily attributable to (i) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing related to the tranche rights that were established at the time of the deal closing, (ii) the German Federal Ministry of Finance grant of $1.1 million being recognized in the fourth quarter of 2023 and (iii) a $0.4 million decrease in other grants which were received in 2023. The decrease was offset by a $0.9 million increase in foreign exchange gains. Net Loss for the three months ended September 30, 2024, was approximately $24.4 million, or $0.24 per basic and diluted share, based on 101,272,580 weighted average common shares outstanding, compared to a net loss of approximately $22.8 million, or $0.51 per basic and diluted share, based on 44,574,377 weighted average common shares outstanding for the same period ended September 30, 2023. Net loss for the nine months ended September 30, 2024, was approximately $75.3 million, or $0.75 per basic and diluted share, based on 99,998,245 weighted average common shares outstanding, compared to a net loss of approximately $72.0 million or $1.63 per basic and diluted share, based on 44,227,264 weighted average common shares outstanding for the same period ended September 30, 2023. Cash and Cash Equivalents as of September 30, 2024 were $59.1 million. With these funds, Immunic expects to be able to fund its operations into the third quarter of 2025. Webcast Information Immunic will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: or on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial-in access. An archived replay of the webcast will be available approximately one hour after completion on Immunic's website at: ir.imux.com/events-and-presentations. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, new management hires and promotions, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure of the company; and the company's expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, including the ability to satisfy the minimum average price and trading volume conditions required to receive funding in tranche 2 and 3 of the January 2024 private placement, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] Financials SOURCE Immunic, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultFinancial StatementExecutive ChangePhase 3

08 May 2024

·www.biospace.com

Immunic, Inc. Reports First Quarter 2024 Financial Results and Provides Corporate Update

Substantially Bolstered Balance Sheet Through a Three-Tranche Private Placement Totaling Up to $240 Million, Extending Cash Runway Into the Third Quarter of 2025, Based on Initial $80 Million Tranche Received Fourth U.S. Patent Directed to Use of Vidofludimus Calcium in Multiple Sclerosis; Multilayered Intellectual Property Strategy Provides Protection Into 2041 in the United States Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain Underway Webcast to be Held Today, May 8, 2024, at 8:00 am ET NEW YORK, May 8, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced financial results for the first quarter ended March 31, 2024, and provided a corporate update. "During the first quarter and subsequent period, we have continued to advance both the phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and the twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS), for our potentially groundbreaking, orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838)," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Just last month, we hosted a Multiple Sclerosis (MS) R&D Day, highlighting the latest developments in the MS landscape as well as our highly encouraging preclinical and clinical data supporting the neuroprotective potential and reduced disability-worsening associated with vidofludimus calcium, which represent important distinctions compared to currently available MS therapies. We also shared our strong belief that vidofludimus calcium could elevate today's standard of care by providing a holistic solution for the full spectrum of MS patients, given that it is designed to selectively manage all three components of smoldering MS with its neuroprotective, anti-inflammatory and antiviral effects. Importantly, the clear separation from placebo in serum neurofilament light chain (NfL) levels in patients with PMS and non-relapsing secondary progressive multiple sclerosis (SPMS), which was observed in the recent interim analysis from our phase 2 CALLIPER trial, is significant, and, if this separation is also evident in the top-line CALLIPER data expected in April of next year, we may also be able to position vidofludimus calcium as the first oral treatment option for non-relapsing SPMS. Additionally, as it relates to our phase 3 ENSURE program, we expect to read-out the first of the ENSURE trials in the second quarter of 2026 and anticipate reading out the second ENSURE trial in the second half of 2026." "We are well capitalized to execute on our upcoming MS milestones, following our successful January 2024, three-tranche private placement of up to $240 million, with a group of top-tier new and existing investors, which we believe reflects the enormous potential of our clinical programs. In addition to strengthening our capital position, we also continued to build on the several layers of patents, currently protecting vidofludimus calcium into 2041 in the United States, with the United States Patent and Trademark Office's (USPTO) Notice of Allowance last month for our fourth patent application covering a key composition-of-matter of a specific polymorph of vidofludimus calcium and related production of the material." Dr. Vitt concluded, "Our second program, IMU-856, an orally available, systemically acting small molecule modulator that targets Sirtuin 6 ("SIRT6"), a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, also shows great promise. As we have noted previously, based on initial clinical proof-of-concept data, we believe that IMU-856 could be an entirely new therapeutic approach to treating gastrointestinal disorders by restoring a healthy gut through renewal of the bowel wall. In particular, the data from our phase 1b clinical trial in celiac disease patients during periods of gluten-free diet and gluten challenge demonstrated positive effects for IMU-856 over placebo in four key dimensions of celiac disease pathophysiology: protection of the gut architecture, improvement of patients' symptoms, biomarker response, and enhancement of nutrient absorption. We are currently preparing clinical phase 2 testing of IMU-856 in patients with ongoing active celiac disease (OACD) despite gluten-free diet, while also exploring the possibility of additional clinical uses in other gastrointestinal conditions." First Quarter 2024 and Subsequent Highlights April 2024: Hosted an MS R&D Day, during which management discussed the latest developments in the MS landscape, along with recent preclinical and clinical data supporting the neuroprotective potential of vidofludimus calcium. March 2024: Received Notice of Allowance from the USPTO for patent application 16/981,122 entitled, "Calcium salt polymorphs as anti-inflammatory, immunomodulatory and anti-proliferative agents," covering the composition-of-matter of a specific polymorph of vidofludimus calcium and a related method of production of the material. February 2024: Presented data from the company's phase 2 CALLIPER and CALVID-1 clinical trials of vidofludimus calcium, in two poster presentations at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024. January 2024: Announced a three-tranche private placement totaling up to $240 million, with participation from select new and existing investors. These included lead investor BVF Partners, alongside Avidity Partners, Janus Henderson Investors, Soleus Capital, RTW Investments and Adage Capital Partners. The initial tranche successfully closed on January 8, 2024, with Immunic securing $80 million in gross proceeds. Clinical Development Programs Vidofludimus calcium in MS: Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April 2025. An interim futility analysis of the ENSURE program is expected in late 2024. The read-out of the first of the ENSURE trials is currently anticipated in the second quarter of 2026; and the second ENSURE trial in the second half of 2026. IMU-856 in celiac disease: Based on the positive data from the phase 1b clinical trial, the company is preparing for clinical phase 2 testing of IMU-856 in OACD patients despite gluten-free diet. Financial and Operating Results 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. The decreases were partially offset by a $0.7 million increase in personnel costs, $0.3 million of which is related to non-cash stock compensation and the remainder of which is due to an increase in headcount. General and Administrative (G&A) Expenses were $5.1 million for the three months ended March 31, 2024, as compared to $4.2 million for the same period ended March 31, 2023. The $0.9 million increase was primarily due to (i) a $0.8 million increase in personnel expense in general and administrative, $0.5 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount and (ii) $0.1 million in legal and consultancy expenses. Interest Income was $1.2 million for the three months ended March 31, 2024, as compared to $0.8 million for the same period ended March 31, 2023. The $0.4 million increase was due to higher interest rates. The Change in Fair Value of the Tranche Rights of $4.8 million for the three months ended March 31, 2024 was a non-cash charge related to the change in value of the tranche rights associated with the future tranches 2 and 3 of the January 2024 private placement. Other Income (Expense) was ($2.1 million) for the three months ended March 31, 2024, as compared to $1.2 million for the same period ended March 31, 2023. The $3.3 million decrease was primarily attributable to (i) a $1.7 million expense related to the portion of deal costs from the January 2024 private placement related to the tranche rights that were established at the time of the closing of tranche 1, (ii) the German Federal Ministry of Finance grant of $1.1 million being recognized in the fourth quarter of 2023 which was one quarter earlier than in the prior year when the grant was recognized in the first quarter of 2023 and (iii) a $0.5 million decrease in research and development tax incentives for clinical trials in Australia as a result of decreased spending on clinical trials in Australia. Net Loss for the three months ended March 31, 2024, was approximately $29.6 million, or $0.30 per basic and diluted share, based on 97,299,955 weighted average common shares outstanding, compared to a net loss of approximately $25.3 million, or $0.58 per basic and diluted share, based on 43,664,783 weighted average common shares outstanding for the same period ended March 31, 2023. Cash and Cash Equivalents as of March 31, 2024 were $97.3 million. With these funds, Immunic expects to be able to fund its operations into the third quarter of 2025. Webcast Information Immunic will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: or on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access. An archived replay of the webcast will be available approximately one hour after completion on Immunic's website at: ir.imux.com/events-and-presentations. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; and the company's expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements including the ability to satisfy the conditions required to receive funding in tranche 2 and 3 of the January 2024 private placement, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 jessica.breu@imux.com US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 immunic@rxir.com US Media Contact KOGS Communication Edna Kaplan +1 617 974 8659 kaplan@kogspr.com Financials View original content to download multimedia: SOURCE Immunic, Inc. Company Codes: NASDAQ-NMS:IMUX

Phase 2Financial StatementPhase 1Clinical ResultPhase 3

22 Feb 2024

·www.prnewswire.com

Immunic, Inc. Reports Year End 2023 Financial Results and Provides Corporate Update

– Significantly Strengthened Balance Sheet in January 2024 with Execution of Three-Tranche Private Placement of up to $240 Million, Extending Cash Runway Into the Third Quarter of 2025 Based on Initial $80 Million Tranche – – Evidence for Neuroprotective Activity of Vidofludimus Calcium from Phase 2 CALLIPER Interim Analysis, Consistent Across the Entire Progressive Multiple Sclerosis Population and All Subtypes; Top-Line CALLIPER Data Expected in April 2025 – – Phase 3 ENSURE Program in Relapsing Multiple Sclerosis Ongoing – – Expanded Vidofludimus Calcium Patent Portfolio with Additional New Patents Granted; Exclusivity Protection Expected Into 2041 in the United States, Unless Extended Further – – Webcast to be Held Today, February 22, 2024, at 8:00 am ET – NEW YORK, Feb. 22, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update. "Immunic made remarkable progress throughout 2023, and these achievements were punctuated by the successful three-tranche private placement of up to $240 million, which we announced last month. Our ability to execute this transaction, with a group of top-tier, existing and new investors, we believe affirms the enormous value inherent in our two advanced clinical programs" stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "During the fourth quarter, we reported an interim biomarker analysis from our phase 2 CALLIPER trial of our lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium. The highly encouraging results demonstrated clear separation from placebo in serum neurofilament light chain (NfL) levels in patients with progressive multiple sclerosis (PMS). Notably, this effect was observed across all subpopulations, including advanced secondary progressive multiple sclerosis (SPMS), which we believe is a segment of very high unmet need in multiple sclerosis (MS). Further, if the top-line CALLIPER data, expected in April 2025, continues to show a neuroprotective effect, we may be able to position vidofludimus calcium as the first oral treatment option for advanced SPMS. This eagerly anticipated data is fully funded by the first $80 million tranche of our recent financing, which extended our cash runway into the third quarter of 2025. An interim futility analysis for our phase 3 ENSURE program is expected late this year, and the read-out of the first of the ENSURE trials is anticipated in the second quarter of 2026. If approved, we believe that vidofludimus calcium has the potential to be a unique treatment option targeted to the complex pathophysiology of MS, based on its combined neuroprotective, anti-inflammatory, and antiviral effects. It is important to note that we continue to build on the multiple layers of patent protection around vidofludimus and its salt and free acid forms. In November, we were granted two fundamental new patents in the United States covering the specific dose strength used in clinical trials for the treatment of relapsing multiple sclerosis (RMS), as well as the dosing regimens associated with the treatment of MS. As a result, our extensive patent portfolio now provides protection into 2041 in the United States, unless extended further." Dr. Vitt continued, "During the fourth quarter, we presented the previously reported positive results from our phase 1b clinical trial of our second key clinical program, IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), in patients with celiac disease, at two prestigious medical conferences. The results demonstrated meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. We believe this data provides initial clinical proof-of-concept for a potentially new, oral therapeutic approach to a multitude of gastrointestinal disorders through the regeneration of bowel architecture, rather than the traditional immunomodulatory approaches used in many gastrointestinal indications, today. We are currently preparing for phase 2 testing in ongoing active celiac disease (OACD) and are considering additional clinical applications in other gastrointestinal disorders." Fourth Quarter 2023 and Subsequent Highlights January 2024: Announced a three-tranche private placement of up to $240 million, with participation from select new and existing investors, including lead investor BVF Partners, as well as Avidity Partners, Janus Henderson Investors, Soleus Capital, RTW Investments and Adage Capital Partners. A total of $80 million in gross proceeds was received by Immunic in the first tranche, which closed on January 8, 2024. November 2023: Received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 17/992,162, covering the dosing regimens associated with vidofludimus calcium and other salt as well as free acid forms for the treatment of MS, including all regimens tested in the MS clinical program. November 2023: Received a Notice of Allowance from the USPTO for patent application 17/391,442, covering a daily dose of about 10 mg to 45 mg of vidofludimus calcium and other salt as well as free acid forms, including the 30 mg dosage used in the ongoing twin phase 3 ENSURE trials, for the treatment of RMS. The claims are expected to provide protection into 2041, unless extended further. November 2023: Presented data from the phase 1b clinical trial of IMU-856 in patients with celiac disease in a poster presentation at the Association of European Coeliac Societies (AOECS) 35th General Assembly Conference 2023. October 2023: Presented data from the phase 1b clinical trial of IMU-856 in patients with celiac disease in a moderated poster session; along with data from the phase 2 CALDOSE-1 trial of vidofludimus calcium in moderate-to-severe ulcerative colitis (UC) in an oral presentation, both at the United European Gastroenterology Week (UEGW) 2023. October 2023: Presented data from the phase 2 EMPhASIS trial of vidofludimus calcium in relapsing-remitting MS in an ePoster at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting. October 2023: Reported positive interim data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS. Serum NfL improvements were consistently observed for vidofludimus calcium across PMS and all disease subtypes, as well as in patients who showed or did not show disease and/or magnetic resonance imaging (MRI) activity. Immunic believes that this data illustrates biomarker evidence that vidofludimus calcium's activity extends beyond the previously observed anti-inflammatory effects, further reinforcing its neuroprotective potential. Enrollment of the trial was completed in August. In total, 467 patients with primary PMS, or active or non-active SPMS, were randomized to either 45 mg of vidofludimus calcium or placebo. Anticipated Clinical Milestones Vidofludimus calcium in MS: Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April 2025. An interim futility analysis of the ENSURE program is expected in late 2024. The read-out of the first of the ENSURE trials is currently anticipated in the second quarter of 2026; and the second ENSURE trial in the second half of 2026. IMU-856 in celiac disease: Based on the positive data from the phase 1b clinical trial, the company is preparing for clinical phase 2 testing of IMU-856 in OACD patients despite gluten-free diet. Financial and Operating Results Research and Development (R&D) Expenses were $83.2 million for the twelve months ended December 31, 2023, as compared to $71.2 million for the twelve months ended December 31, 2022. The $12.0 million increase reflects (i) a $19.1 million increase in external development costs related to the ongoing clinical programs of vidofludimus calcium in RMS and PMS, the ongoing IMU-856 clinical program as well as increased drug supply costs for vidofludimus calcium to support ongoing trials and (ii) a $2.2 million increase in personnel expense in research and development related to an increase in headcount, $0.2 million of which was due to non-cash stock based compensation. The increases were partially offset by (i) a decrease of $6.5 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer, (ii) a decrease of $2.5 million in external development costs related to the phase 2 clinical trial of vidofludimus calcium in ulcerative colitis and (iii) a $0.3 million increase in related costs across numerous categories. General and Administrative (G&A) Expenses were $16.0 million for the twelve months ended December 31, 2023, as compared to $15.3 million for the same period ended December 31, 2022. The $0.7 million increase was primarily due to (i) a $0.9 million increase in legal and consultancy expense, travel expense and facility expenses and (ii) a $0.3 million increase across numerous categories. The increases were partially offset by a decrease of $0.5 million in personnel expense in general and administrative which was primarily due to non-cash stock based compensation decrease. Other Income (Expense) was $5.6 million for the twelve months ended December 31, 2023, as compared to ($0.9 million) for the same period ended December 31, 2022. The $6.5 million increase was primarily attributable to (i) a $3.9 million decrease in foreign exchange losses, (ii) a $2.3 million research allowance attributable to tax year 2021 and 2022 from the German Federal Ministry of Finance and (iii) a $2.0 million increase in interest income as a result of higher interest rates. The increase was partially offset by (i) a $1.6 million decrease in research and development tax incentives for clinical trials in Australia as a result of decreased spending on clinical trials in Australia and (ii) a $0.1 million decrease across numerous categories. Net Loss for the twelve months ended December 31, 2023, was approximately $93.6 million, or $2.11 per basic and diluted share, based on 44,320,050 weighted average common shares outstanding, compared to a net loss of approximately $120.4 million, or $3.78 per basic and diluted share, based on 31,819,006 weighted average common shares outstanding for the same period ended December 31, 2022. Cash, Cash Equivalents and Investments as of December 31, 2023 were $46.7 million. With these funds and the approximately $75.0 million in net proceeds raised in the first tranche of the January 2024 private placement, Immunic expects to be able to fund its operations into the third quarter of 2025. Webcast Information Immunic will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: or on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access. An archived replay of the webcast will be available approximately one hour after completion on Immunic's website at: ir.imux.com/events-and-presentations. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; and the company's expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KOGS Communication Edna Kaplan +1 617 974 8659 [email protected] Financials SOURCE Immunic, Inc.

Phase 2Clinical ResultPhase 1Financial StatementPhase 3

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 1	GB	Immunic AG	09 Dec 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Corporate Publications Manual	Phase 1	Psoriasis	41	IMU 935	(mmehhhlfmd) = administration of IMU-935 and placebo in this trial were demonstrated to be safe and well-tolerated ztlyvztsor (cewrqobrwj )	Negative	20 Oct 2022
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