Brain-eating amoebas are rare. But hot weather increases the risk.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
21 minutes ago
- Yahoo
Lilly's oral GLP-1, orforglipron, delivers weight loss of up to an average of 27.3 lbs in first of two pivotal Phase 3 trials in adults with obesity
In ATTAIN-1, the investigational once-daily oral pill showed significant efficacy, and a safety and tolerability profile consistent with injectable GLP-1 therapies at 72 weeks Orforglipron achieved the primary and all key secondary endpoints, including demonstrating improvements in a number of cardiovascular risk factors With these results, Lilly is on track to submit orforglipron to global regulatory agencies by year-end and is making substantial investments to meet anticipated demand at launch INDIANAPOLIS, Aug. 7, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 ATTAIN-1 trial, evaluating orforglipron, an investigational oral glucagon-like peptide-1 (GLP-1) receptor agonist, in 3,127 adults with obesity, or overweight with a weight-related medical problem and without diabetes. At 72 weeks, all three doses of orforglipron, met the primary endpoint and all key secondary endpoints compared to placebo, delivering clinically meaningful weight loss as an adjunct to a healthy diet and physical activity. For the primary endpoint, orforglipron 36 mg, taken once per day without food and water restrictions, lowered weight by an average of 12.4% (27.3 lbs) compared to 0.9% (2.2 lbs) with placebo using the efficacy estimand.1 "Obesity is one of the most pressing global health challenges of our time, driving global chronic disease burden and impacting more than one billion people worldwide," said Kenneth Custer, Ph.D., executive vice president and president of Lilly Cardiometabolic Health. "With orforglipron, we're working to transform obesity care by introducing a potential once-daily oral therapy that could support early intervention and long-term disease management, while offering a convenient alternative to injectable treatments. With these positive data in hand, we are now planning to submit orforglipron for regulatory review by year-end and are prepared for a global launch to address this urgent public health need." In the ATTAIN-1 trial, orforglipron met the primary endpoint of superior body weight reduction compared to placebo. Participants taking the highest dose of orforglipron lost an average of 27.3 lbs (12.4%) at 72 weeks using the efficacy estimand. In a key secondary endpoint, 59.6% of participants taking the highest dose of orforglipron lost at least 10% of their body weight, while 39.6% lost at least 15% of their body weight. In addition to achieving significant weight loss, orforglipron was also associated with reductions in known markers of cardiovascular risk, including non-HDL cholesterol, triglycerides and systolic blood pressure in pooled analyses across all doses. In a pre-specified exploratory analysis, the highest dose of orforglipron reduced high-sensitivity C-reactive protein (hsCRP) levels by 47.7%. Efficacy Estimand ResultsOrforglipron 6 mg Orforglipron 12 mg Orforglipron 36 mg Placebo Primary Endpoint Mean percent change in body weight from of 103.2 kg(227.5 lbs) and 37.0 BMIi -7.8% (-8.0 kg; -17.6 lbs) -9.3% (-9.4 kg; -20.7 lbs) -12.4% (-12.4 kg; -27.3 lbs) -0.9% (-1.0 kg; -2.2 lbs) Key Secondary Endpoints Percentage of participants achievingbody weight reductionsof ≥10%i 35.9 % 45.1 % 59.6 % 8.6 % Percentage of participants achieving body weight reductionsof ≥15%i 16.5 % 24.0 % 39.6 % 3.6 % iSuperiority test was adjusted for multiplicity. For the treatment-regimen estimand,2 each dose of orforglipron led to statistically significant improvements across the primary and all key secondary endpoints. Percent weight reduction: -7.5% (-7.8 kg; 17.2 lbs; 6 mg), -8.4% (-8.6 kg; 19.0 lbs; 12 mg), -11.2% (-11.3 kg; 25.0 lbs; 36 mg), -2.1% (-2.4 kg; 5.3 lbs; placebo) Percentage of participants achieving body weight reductions of ≥10%: 33.3% (6 mg), 40.0% (12 mg), 54.6% (36 mg), 12.9% (placebo) Percentage of participants achieving body weight reductions of ≥15%: 15.1% (6 mg), 20.3% (12 mg), 36.0% (36 mg), 5.9% (placebo) The overall safety profile of orforglipron in ATTAIN-1 was consistent with the established GLP-1 receptor agonist class. The most commonly reported adverse events were gastrointestinal-related and generally mild-to-moderate in severity. The most common adverse events for participants treated with orforglipron (6 mg, 12 mg and 36 mg, respectively) were nausea (28.9%, 35.9% and 33.7%) vs. 10.4% with placebo, constipation (21.7%, 29.8% and 25.4%) vs. 9.3% with placebo, diarrhea (21.0%, 22.8% and 23.1%) vs. 9.6% with placebo, vomiting (13.0%, 21.4% and 24.0%) vs. 3.5% with placebo, and dyspepsia (13.0%, 16.2% and 14.1%) vs. 5.0% with placebo. Treatment discontinuation rates due to adverse events were 5.1% (6 mg), 7.7% (12 mg) and 10.3% (36 mg) for orforglipron vs. 2.6% with placebo. The overall treatment discontinuation rates were 21.9% (6 mg), 22.5% (12 mg) and 24.4% (36 mg) for orforglipron vs. 29.9% with placebo. No hepatic safety signal was observed. The detailed ATTAIN-1 results will be presented next month at the European Association for the Study of Diabetes (EASD) Annual Meeting 2025 and published in a peer-reviewed journal. More results from the ATTAIN Phase 3 clinical trial program will be shared later this year, along with findings from the ACHIEVE Phase 3 clinical trial program evaluating orforglipron for adults with type 2 diabetes. About orforglipron Orforglipron (or-for-GLIP-ron) is an investigational, once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.3 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Chugai and Lilly published the preclinical pharmacology data of this molecule together.4 Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea (OSA) and hypertension in adults with obesity. About ATTAIN-1 and ATTAIN clinical trial program ATTAIN-1 (NCT05869903) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron 6 mg, 12 mg and 36 mg as monotherapy to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, OSA or cardiovascular disease, who did not have diabetes. The trial randomized 3,127 participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan in 3:3:3:4 ratio to receive either 6 mg, 12 mg or 36 mg orforglipron or placebo. The primary objective of the study was to demonstrate that orforglipron (6 mg, 12 mg, 36 mg) is superior to placebo in body weight reduction from baseline after 72 weeks in people with a BMI ≥30.0 kg/m² or a BMI ≥27.0 kg/m² with at least one weight-related comorbidity and a history of at least one self-reported unsuccessful dietary effort to lose body weight. All participants in the orforglipron treatment arms started the study at a dose of orforglipron 1 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 6 mg (via steps at 1 mg and 3 mg), 12 mg (via steps at 1 mg, 3 mg and 6 mg) or 36 mg (via steps at 1 mg, 3 mg, 6 mg, 12 mg and 24 mg). Dose reduction was only allowed for GI tolerability if other mitigations failed. The ATTAIN Phase 3 global clinical development program for orforglipron has enrolled more than 4,500 people with obesity or overweight across two global registration trials. The program began in 2023 with additional results anticipated this year. About LillyLilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram and LinkedIn. P-LLY Endnotes and References: The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments. The treatment-regimen estimand represents the estimated average treatment effect regardless of adherence to study intervention or initiation of prohibited weight management treatments. Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. doi: 10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152. T. Kawai, B. Sun, H. Yoshino, D. Feng, Y. Suzuki, M. Fukazawa, S. Nagao, D.B. Wainscott, A.D. Showalter, B.A. Droz, T.S. Kobilka, M.P. Coghlan, F.S. Willard, Y. Kawabe, B.K. Kobilka, & K.W. Sloop, Structural basis for GLP-1 receptor activation by LY3502970, an orally active nonpeptide agonist, Proc. Natl. Acad. Sci. U.S.A. 117 (47) 29959-29967, (2020). Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about orforglipron as a potential treatment for adults with obesity or overweight, Lilly's ability to supply orforglipron, if approved, and the timeline for future readouts, presentations, and other milestones relating to orforglipron and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that orforglipron will prove to be a safe and effective treatment for obesity or overweight, that orforglipron will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade NamesAll trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Refer to: Brooke Frost; 317-432-9145 (Media)Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors) View original content to download multimedia: SOURCE Eli Lilly and Company Sign in to access your portfolio
Yahoo
21 minutes ago
- Yahoo
Digital Weight Loss App Noom Undercuts Wegovy With Low-Price Offer
Popular digital weight loss app,Noom (NOOM) undercuts Novo Nordisk's (NYSE:NVO) Wegovy by offering quarter-dose packs at $119 for the first month, aiming to broaden access to GLP-1 therapy. Warning! GuruFocus has detected 1 Warning Sign with NVO. Noom will then charge $199 monthly for the same 0.6 mg dose, versus Wegovy's standard 2.4 mg at over $1,300 per month. Its GLP-1Rx program adds compounded semaglutide up to 1.2 mg at $149 in month one and $279 thereafter. Noom also sells generic liraglutide alongside Eli Lilly's Zepbound (NYSE:LLY) at $349, creating a tiered pricing ladder to suit different budgets. Rival Hims and Hers Health (NYSE:HIMS) offers compounded semaglutide for $199 per month on a prepaid plan, putting pressure on Noom to prove its lower-price strategy can win share. Noom says the move cuts cost barriers and could drive a surge in its digital weight-loss subscriptions. Lower-tier pricing may fuel subscriber growth and recurring revenue in the $50 B obesity-treatment will watch Noom's Q2 earnings on Aug 23 for subscriber counts, margin trends and guidance. This article first appeared on GuruFocus.
Yahoo
21 minutes ago
- Yahoo
Immunic, Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update
– Vidofludimus Calcium Substantially Reduced 24-Week Confirmed Disability Worsening in Phase 2 CALLIPER Trial in Overall Progressive Multiple Sclerosis Study Population and Across Subtypes, Reinforcing the Drug's Neuroprotective Potential and Ability to Slow Disease Progression – – Completed Enrollment for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected by End of 2026 – – New Long-Term Open-Label Extension Data From Phase 2 EMPhASIS Trial in Relapsing-Remitting Multiple Sclerosis Showed High Rates of Patients Remaining Free of 12-Week and 24-Week Confirmed Disability Worsening – – Strengthened Balance Sheet with Two Financings Totaling $70.1 Million in Gross Proceeds – NEW YORK, Aug. 7, 2025 /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 second quarter and six months ended June 30, 2025, and provided a corporate update. "During the second quarter and more recently, we have made substantial clinical progress in advancing our potentially transformative lead asset, vidofludimus calcium (IMU-838), an orally available nuclear receptor-related 1 (Nurr1) activator," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "Most notable was the on-time completion of enrollment of our twin phase 3 ENSURE trials, bringing us one step closer to delivering a novel treatment option for people living with relapsing multiple sclerosis (RMS). The unique neuroprotective effects observed to date also support the phase 3 ENSURE trials, where confirmed disability worsening will be analyzed. Top-line data from both trials, expected by the end of 2026, will allow for a synchronized readout and a pooled analysis of this clinical endpoint. The growing body of evidence we have amassed continues to strengthen our confidence that, if approved, vidofludimus calcium, with a distinct combination of neuroprotective, anti-inflammatory and anti-viral properties observed, as well as a well-established safety and tolerability profile, has the potential to emerge as a differentiated oral therapy that addresses the complex pathophysiology of multiple sclerosis (MS)." "We also reported strong results from our phase 2 CALLIPER trial in progressive multiple sclerosis (PMS), showing a 23.8% reduction in time to 24-week confirmed disability worsening (24wCDW) in the overall study population compared to placebo. In the high unmet need subgroup of primary progressive MS (PPMS), this effect was 31.3%, exceeding outcomes observed in previous PPMS trials. In another high unmet need subtype, non-active SPMS (naSPMS), the reduction was 19.2%. Moreover, patients without gadolinium-enhancing lesions at baseline, who often do not benefit from existing treatments, saw 24wCDW reductions of 33.7% for the overall PMS population, as well as 34.4% and 29.8% for the PPMS and naSPMS subgroups, respectively. Since time to 24wCDW is a recognized regulatory endpoint for assessing clinical benefit in PMS, we believe these findings strongly support advancing vidofludimus calcium into phase 3 development in progressive forms of MS. With only one approved treatment currently available for PPMS, vidofludimus calcium may be a highly promising option for this underserved $6+ billion market, where reduction of disease progression would allow patients to remain more independent, manage symptoms more easily and achieve better long-term outcomes." Management noted that, among the continued stream of positive data for vidofludimus calcium was the new readout from the long-term open-label extension (OLE) phase of the phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS), which further reinforced the strong efficacy signals previously observed in this trial. Data showed that at week 144, 92.3% of patients remained free of 12-week confirmed disability worsening (12wCDW), and 92.7% were free of 24wCDW. This, and previously announced results across the MS program—including the top-line EMPhASIS and CALLIPER data—further support the potential of vidofludimus calcium to slow disease progression. These findings also continue to highlight its neuroprotective effects, which are believed to be mediated through activation of the Nurr1 target. Based on the strength of the data, a total of five abstracts have been selected for presentation at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September, including one oral presentation and one late-breaking poster – a major achievement for the company. Dr. Vitt added, "Beyond vidofludimus calcium, compelling clinical and preclinical data for IMU-856, our orally available and systemically acting small molecule modulator that targets sirtuin 6 (SIRT6), indicates the drug's strong promise as a potential novel therapeutic for gastrointestinal disorders. Based on encouraging data available to date, we are preparing for further clinical testing while exploring potential financing, licensing, or partnership opportunities to advance the program. Additionally, IMU-856 has shown potential as an oral treatment option for weight management. More specifically, a post hoc analysis of our phase 1b clinical trial results showed up to a 250% increase in GLP-1 levels versus placebo in fasting celiac disease patients, mimicking natural post-meal responses and suggesting that IMU-856 may activate enteroendocrine pathways physiologically, offering a broader mechanism than current injectable incretin mimetics. If validated in future trials, this once-daily oral small molecule could become a convenient treatment alternative for weight management." Second Quarter 2025 and Subsequent Highlights April 2025: Announced positive data from the phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS. The results demonstrated reduced relative risks of 24wCDW events in the overall study population as well as PMS subtypes compared to placebo. Notably, the drug showed a consistent reduction of disability worsening in subpopulations without inflammatory lesions at baseline and reduced 24wCDW in patients without gadolinium-enhancing lesions at baseline. Vidofludimus calcium substantially reduced the annualized rate of thalamic brain volume loss and the volume of new/enlarging T2 lesions compared to placebo. No new safety signals were identified, confirming the favorable safety and tolerability profile already observed in previous clinical trials. April 2025: Announced a $5.1 million registered direct offering led by Aberdeen Investments. May 2025: Announced an oversubscribed $65 million underwritten public offering. The company may receive up to an aggregate of $130 million of additional proceeds if the Series A Warrants and Series B Warrants are exercised in full for cash. The financing was co-led by BVF Partners and Coastlands Capital, and included participation from Aberdeen Investments, Adage Capital Partners LP, Janus Henderson Investors, and other institutional investors. June 2025: Announced additional data underlining the positive outcome of the phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS. The data for the secondary endpoint of time to 24wCDW, based on the Expanded Disability Status Scale (EDSS), further reinforced the neuroprotective potential of vidofludimus calcium. Similarly, consistent with the top-line data, further analyses of subpopulations – both with and without inflammatory gadolinium-enhanced lesion activity at baseline – continued to demonstrate promising results. June 2025: Announced the on-time completion of enrollment for both phase 3 ENSURE trials of vidofludimus calcium in patients with RMS. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized at more than 100 sites in 15 countries. June 2025: Reported new, long-term OLE data from the phase 2 EMPhASIS trial of vidofludimus calcium in patients with RRMS. At week 144, 92.3% of patients remained free of 12wCDW and 92.7% remaining free of 24wCDW. Vidofludimus calcium continued to demonstrate a favorable safety and tolerability profile with long-term data available up to 5.5 years. Anticipated Clinical Milestones Vidofludimus calcium in MS: Top-line data from the twin phase 3 ENSURE-1 and ENSURE-2 trials is expected by the end of 2026. IMU-856: The company is preparing for further clinical 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 June 30, 2025, as compared to $18.3 million for the three months ended June 30, 2024. The $3.0 million increase reflects (i) a $2.6 million increase in external development costs related to the vidofludimus calcium programs and (ii) a $0.6 million increase in personnel expenses. The increase was offset by a $0.2 million decrease related costs across numerous the six months ended June 30, 2025, R&D expenses were $42.9 million, as compared to $37.1 million for the six months ended June 30, 2024. The $5.8 million increase reflects a $7.3 million increase in external development costs related to the vidofludimus calcium programs. The increase was offset by a $1.5 million decrease in external development costs related to IMU-856 due to the completion of the phase 1b clinical trial in celiac disease patients in 2024. General and Administrative (G&A) Expenses were $5.7 million for the three months ended June 30, 2025, as compared to $4.5 million for the same period ended June 30, 2024. The $1.2 million increase was due to (i) a $0.8 million increase in personnel expenses and (ii) a $0.4 million increase in legal and consultancy expenses. For the six months ended June 30, 2025, G&A expenses were $11.0 million, as compared to $9.6 million for the same period ended June 30, 2024. The $1.4 million increase was due to (i) a $0.7 million increase related to personnel expenses, (ii) a $0.5 million increase in legal and consultancy expenses and (iii) a $0.2 million increase related costs across numerous categories. Interest Income was $0.2 million for the three months ended June 30, 2025, as compared to $1.0 million for the three months ended June 30, 2024. The $0.8 million decrease was due to a lower average cash balance. For the six months ended June 30, 2025, interest income was $0.4 million, as compared to $2.2 million for the same period ended June 30, 2024. The $1.8 million decrease was due to a lower average cash balance. The Change in Fair Value of the Tranche Rights of $4.8 million in the six months ended June 30, 2024, was a non-cash charge related to the change in value of the tranche rights associated with the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially classified as a liability because the company did not have a sufficient number of authorized shares to issue in tranche 2 and tranche 3 of the offering. But these tranche rights 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. There was no change in fair value of the tranche rights recognized in the six months ended June 30, 2025. Other Income (Expense) was $0.02 million for the three months ended June 30, 2025, as compared to $0.4 million for the same period ended June 30, 2024. The $0.4 million decrease was primarily attributable to activity across numerous categories. For the six months ended June 30, 2025, Other Income (Expense) was $1.2 million, as compared to ($1.7 million) for the same period ending June 30, 2024. The $2.8 million increase 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 in 2024, (ii) a $1.0 million grant income of the German Federal Ministry of Finance recognized in the first quarter 2025 and (iii) a $0.1 million increase across numerous categories. Net Loss for the three months ended June 30, 2025, was approximately $27.0 million, or $0.20 per basic and diluted share, based on 132,175,202 weighted average common shares outstanding, compared to a net loss of approximately $21.4 million, or $0.21 per basic and diluted share, based on 101,272,580 weighted average common shares outstanding for the same period ended June 30, 2024. Net loss for the six months ended June 30, 2025, was approximately $52.3 million, or $0.45 per basic and diluted share, based on 116,844,985 weighted average common shares outstanding, compared to a net loss of approximately $51.0 million or $0.51 per basic and diluted share, based on 99,607,158 weighted average common shares outstanding for the same period ended June 30, 2024. Cash and Cash Equivalents as of June 30, 2025 were $55.3 million. With this cash, the company does not have adequate liquidity to fund its operations for at least twelve months from June 30, 2025, without raising additional capital. About 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 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. 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 as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. 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 StatementsThis 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 feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; 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; and the development and commercial potential of any product candidates of the company. 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, increasing inflation, tariffs and macroeconomics trends, 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, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, 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, 2024, filed with the SEC on March 31, 2025, and in the company's subsequent filings with the SEC. Copies of these filings are available online at or 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 of the contents of this press release. Contact Information Immunic, BreuVice President Investor Relations and Communications+49 89 2080 477 US IR ContactRx Communications GroupPaula Schwartz+1 917 633 7790immunic@ US Media ContactKCSA Strategic CommunicationsCaitlin Kasunich+1 212 896 1241ckasunich@ Financials Immunic, Consolidated Statements of Operations(In thousands, except share and per share amounts)(Unaudited) Three Months Ended June 30,Six Months Ended June 30, 2025202420252024 Operating expenses: Research and development$ 21,369$ 18,323$ 42,902$ 37,059 General and administrative5,7144,49111,0069,636 Total operating expenses27,08322,81453,90846,695 Loss from operations(27,083)(22,814)(53,908)(46,695) Other income (expense): Interest income2419984242,185 Change in fair value of the tranche rights———(4,796) Other income (expense), net224361,191(1,658) Total other income (expense)2631,4341,615(4,269) Net loss$ (26,820)$ (21,380)$ (52,293)$ (50,964)Net loss per share, basic and diluted$ (0.20)$ (0.21)$ (0.45)$ (0.51)Weighted-average common shares outstanding, basic and diluted132,175,202101,272,580116,844,98599,607,158 Immunic, Consolidated Balance Sheets(In thousands, except share and per share amounts)(Unaudited)June 30, 2025December 31, 2024(Unaudited) AssetsCurrent assets:Cash and cash equivalents $ 55,310$ 35,668 Other current assets and prepaid expenses 4,5323,664 Total current assets 59,84239,332 Property and equipment, net 612545 Right-of-use assets 975991 Total assets $ 61,429$ 40,868 Liabilities and Stockholders' EquityCurrent liabilities:Accounts payable $ 7,893$ 7,846 Accrued expenses 18,11312,913 Other current liabilities 1,3071,416 Total current liabilities 27,31322,175 Long term liabilitiesOperating lease liabilities 205264 Total long-term liabilities 205264 Total liabilities 27,51822,439 Commitments and contingenciesStockholders' equity:Preferred stock, $0.0001 par value; 20,000,000 shares authorized and no shares issued or outstanding as of June 30, 2025 and December 31, 2024 —— Common stock, $0.0001 par value; 500,000,000 shares authorized as of June 30, 2025 and December 31, 2024, and 98,650,590 and 90,150,869 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively 98 Additional paid-in capital 595,069525,611 Accumulated other comprehensive income 2,5254,209 Accumulated deficit (563,692)(511,399) Total stockholders' equity 33,91118,429 Total liabilities and stockholders' equity $ 61,429$ 40,868 View original content to download multimedia: SOURCE Immunic, Inc. Sign in to access your portfolio
