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Ad hoc announcement pursuant to Art. 53 LR Q3 net sales grew +10% (cc1, +9% USD) with core operating income up +20% (cc, +17% USD) Sales growth driven by continued strong performance from Entresto (+26% cc), Cosentyx (+28% cc), Kisqali (+43% cc), Kesimpta (+28% cc), Pluvicto (+50% cc) and Leqvio (+119% cc)Core operating income margin 40.1%, +340 basis points (cc), mainly driven by higher net sales Q3 operating income grew +123% (cc, +106% USD); net income up +121% (cc, +111% USD)Q3 core EPS grew +20% (cc, +18% USD) to USD 2.06Q3 free cash flow1 of USD 6.0 billion (+18% USD) driven by higher net cash flows from operating activitiesStrong nine months performance with sales up +11% (cc, +9% USD) and core operating income up +20% (cc, +17% USD)Q3 selected innovation milestones: Kisqali FDA approval and positive CHMP opinion for HR+/HER2- stage II and III eBC Fabhalta FDA accelerated approval for IgANPluvicto FDA filing for pre-taxane mCRPC Full-year 2024 guidance raised2 Net sales expected to grow low double-digit (from high single to low double-digit)Core operating income expected to grow high teens (from mid to high teens) Basel, October 29, 2024 – commenting on Q3 2024 results, Vas Narasimhan, CEO of Novartis, said: “Novartis delivered another quarter of strong operational performance in Q3, with sales up 10% and core operating income up 20%. All key growth drivers contributed to the momentum. We achieved important indications expansions for Kisqali in early breast cancer and Fabhalta in IgA nephropathy, and we completed our PSMAfore filing for Pluvicto in the US. With the momentum in our business and pipeline, we were able to once again upgrade our full-year guidance and remain highly confident in our mid-term outlook.” Key figuresContinuing operations3 Q3 2024Q3 2023% change9M 20249M 2023% change USD m USD mUSDcc USD m USD mUSDccNet sales12 82311 782910 37 16434 017911Operating income3 6271 762106123 11 0147 1875361Net income3 1851 513111121 9 1195 9345462EPS (USD)1.580.73116127 4.502.845867Free cash flow5 9655 04318 12 61811 01915 Core operating income5 1454 4051720 14 63512 5511720Core net income4 1333 5851517 11 82210 3201518Core EPS (USD)2.061.741820 5.834.951821 1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 46 of the Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. Please see detailed guidance assumptions on page 7. 3. As defined on page 35 of the Interim Financial Report, Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities and Discontinued operations include operational results from the Sandoz business.StrategyOur focus In 2023, Novartis completed its transformation into a “pure-play” innovative medicines business. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan. Our priorities Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility. Strengthening foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society. Financials Following the September 15, 2023, shareholder approval of the spin-off of Sandoz, Novartis reported its consolidated financial statements as “continuing operations” and “discontinued operations.” Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities. Discontinued operations include the Sandoz Division and selected portions of corporate activities attributable to Sandoz’s business, as well as certain expenses related to the spin-off. While the commentary below focuses on continuing operations, we also provide information on discontinued operations. Continuing operations Third quarter Net sales were USD 12.8 billion (+9%, +10% cc), with volume contributing 12 percentage points to growth. Generic competition had a negative impact of 2 percentage points and pricing was flat. Operating income was USD 3.6 billion (+106%, +123% cc), mainly driven by lower impairments and higher net sales, partly offset by higher R&D investments. Net income was USD 3.2 billion (+111%, +121% cc), mainly driven by higher operating income. EPS was USD 1.58 (+116%, +127% cc), benefiting from the lower weighted average number of shares outstanding. Core operating income was USD 5.1 billion (+17%, +20% cc), mainly driven by higher net sales, partly offset by higher R&D investments. Core operating income margin was 40.1% of net sales, increasing 2.7 percentage points (+3.4 percentage points cc). Core net income was USD 4.1 billion (+15%, +17% cc), mainly due to higher core operating income. Core EPS was USD 2.06 (+18%, +20% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow from continuing operations amounted to USD 6.0 billion (+18% USD), compared with USD 5.0 billion in the prior-year quarter, driven by higher net cash flows from operating activities from continuing operations. Nine months Net sales were USD 37.2 billion (+9%, +11% cc) with volume contributing 14 percentage points to growth. Generic competition had a negative impact of 2 percentage points and pricing had a negative impact of 1 percentage point. Operating income was USD 11.0 billion (+53%, +61% cc), mainly driven by higher net sales, lower impairments and restructuring charges, partly offset by prior-year one-time income from legal matters and higher R&D investments. Net income was USD 9.1 billion (+54%, +62% cc), mainly driven by higher operating income. EPS was USD 4.50 (+58%, +67% cc), benefiting from the lower weighted average number of shares outstanding. Core operating income was USD 14.6 billion (+17%, +20% cc), mainly driven by higher net sales, partly offset by higher R&D investments. Core operating income margin was 39.4% of net sales, increasing 2.5 percentage points (+3.2 percentage points cc). Core net income was USD 11.8 billion (+15%, +18% cc), mainly due to higher core operating income. Core EPS was USD 5.83 (+18%, +21% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow from continuing operations amounted to USD 12.6 billion (+15% USD), compared with USD 11.0 billion in the prior-year period, driven by higher net cash flows from operating activities from continuing operations. Discontinued operations Discontinued operations include the Sandoz generic pharmaceuticals and biosimilars division, certain corporate activities attributable to Sandoz and certain other expenses related to the spin-off of the Sandoz business. Third quarter As the Sandoz spin-off was completed on October 3, 2023, there were no operating results in the third quarter of 2024 related to discontinued operations. In the third quarter of 2023, discontinued operations net sales were USD 2.5 billion, operating loss amounted to USD 86 million and net income from discontinued operations was USD 250 million. For further details see Note 3 “Significant acquisition of businesses and spin-off of Sandoz business” and Note 11 “Discontinued operations” to the condensed interim consolidated financial statements. Nine months As the Sandoz spin-off was completed on October 3, 2023, there were no operating results in the first nine months of 2024 related to discontinued operations. In the first nine months of 2023, discontinued operations net sales were USD 7.4 billion, operating income amounted to USD 265 million and net income from discontinued operations was USD 440 million. For further details see Note 3 “Significant acquisition of businesses and spin-off of Sandoz business” and Note 11 “Discontinued operations” to the condensed interim consolidated financial statements. Total Company Third quarter Total Company net income was USD 3.2 billion in 2024, compared to USD 1.8 billion in 2023 and basic EPS was USD 1.58 compared to USD 0.85 in prior year quarter. Net cash flows from operating activities for total Company amounted to USD 6.3 billion and free cash flow amounted to USD 6.0 billion. Nine months Total Company net income was USD 9.1 billion in 2024, compared to USD 6.4 billion in 2023 and basic EPS was USD 4.50 compared to USD 3.05 in prior year. Net cash flows from operating activities for total Company amounted to USD 13.4 billion and free cash flow amounted to USD 12.6 billion. Q3 key growth drivers Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q3 growth) including: Entresto(USD 1 865 million, +26% cc) sustained robust, demand-led growth, with increased penetration in the US and Europe following guideline-directed medical therapy in heart failure, as well as in China with increased penetration in hypertensionCosentyx(USD 1 693 million, +28% cc) sales grew mainly in the US, Europe and emerging growth markets, driven by recent launches (including the HS indication and the IV formulation in the US) and volume growth in core indicationsKisqali(USD 787 million, +43% cc) sales grew strongly across all regions, based on increasing recognition of its overall survival benefit in HR+/HER2- advanced breast cancer and Category 1 NCCN guidelines recommendationKesimpta(USD 838 million, +28% cc) sales grew reflecting increased demand for a high efficacy product with convenient self-administered dosing; the prior-year period benefited from a one-time revenue deduction adjustment in EuropePluvicto(USD 386 million, +50% cc) sales grew in the US and Europe. Q3 sales benefited from a one-time revenue deduction adjustment in Europe. With supply now unconstrained, the focus is on increasing share in established RLT sites, while opening new sites and referral pathways, and initiating new patientsLeqvio(USD 198 million, +119% cc) continued to show steady growth, with a focus on increasing account and patient adoption, and continuing medical educationJakavi(USD 500 million, +18% cc) sales grew across all regions driven by strong demand across indicationsScemblix(USD 182 million, +72% cc) sales grew across all regions demonstrating the continued high unmet need in CMLTafinlar + Mekinist(USD 534 million, +12% cc) sales grew mainly in the US and emerging growth markets, driven by increased demandXolair(USD 418 million, +15% cc) grew mainly in emerging growth markets and EuropeFabhalta(USD 44 million) launch continues in PNH with an approval in IgAN in Q3Ilaris(USD 372 million, +12% cc) sales grew across all regions, led by the US and EuropeLutathera(USD 190 million, +19% cc) sales grew across all regions due to increased demand and earlier line adoption (within indication) in the US and Japan Emerging Growth Markets*Grew +12% (cc) overall. China grew +18% (cc) to USD 1.0 billion, mainly driven by Entresto, Cosentyx and Leqvio *All markets except the US, Canada, Western Europe, Japan, Australia, and New Zealand Net sales of the top 20 brands in the third quarter and nine months Q3 2024 % change9M 2024 % change USD mUSDccUSD mUSD ccEntresto1 86526265 6422830Cosentyx1 69327284 5452425Kesimpta- excl. PY revenue deduction adjust. 838 285528562 27449614962Kisqali 78740432 1314548Promacta/Revolade 569-101 633-4-3Tafinlar + Mekinist 53411121 53179Jakavi 50017181 4491416Tasigna 419-10-91 260-10-9Xolair 41813151 2441517Ilaris 37211121 0961216Pluvicto- excl. revenue deduction adjust. 38651375036 1 04147424742Sandostatin Group 305-10-8 973-3-1Zolgensma 30801 95234Lucentis 245-33-32 834-29-28Exforge Group 174-7-4 544-21Lutathera 1901919 5341717Leqvio 198120119 531129130Scemblix 1827272 4826769Galvus Group 159-12-6 458-15-8Diovan Group 150-22 450-31Top 20 brands total10 292171829 6041719 R&D update - key developments from the third quarter New approvals Kisqali(ribociclib)FDA approved Kisqali with a broad indication for HR+/HER2- stage II and III early breast cancer (eBC) at high risk of recurrence, approximately doubling the population eligible for CDK4/6 inhibitor adjuvant therapy, with the inclusion of those without nodal involvement. In addition, the CHMP issued a positive opinion for Kisqali in eBC in October. Fabhalta(iptacopan)FDA granted accelerated approval to Fabhalta for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. Regulatory updates Pluvicto (lutetium Lu177 vipivotide tetraxetan)Completed FDA submission for Pluvicto pre-taxane mCRPC label expansion based on the positive Phase III PSMAfore study.Scemblix(asciminib)FDA granted Priority Review status to Scemblix for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP). Scemblix is also under regulatory review in this indication in key international markets worldwide, including in China and Japan.Fabhalta(iptacopan)Submissions for the treatment of C3 glomerulopathy (C3G) completed in the EU, China and Japan. Results from ongoing trials and other highlights Kisqali(ribociclib)Results from a four-year post-hoc analysis of the pivotal Phase III NATALEE trial showed the addition of Kisqali to endocrine therapy (ET) in patients with stage II and III HR+/HER2- eBC reduced the risk of recurrence by 28.5% compared to ET alone. This invasive disease-free survival benefit was consistent across all pre-specified patient subgroups, including those with node-negative disease. Results were also consistent across secondary efficacy endpoints, with a trend for improvement in overall survival. Safety and tolerability remained consistent with previously reported results. Data presented at ESMO Congress 2024.Leqvio(inclisiran)In the Phase III V-MONO study, Leqvio demonstrated clinically meaningful and statistically significant low-density lipoprotein cholesterol (LDL-C) lowering versus both placebo and ezetimibe in patients who were at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD) and not receiving lipid-lowering therapy. Novartis plans to present results from this trial at an upcoming medical meeting and share with regulatory agencies including FDA.Kesimpta(ofatumumab)Data from the ALITHIOS open-label extension study showed first-line Kesimpta treatment for up to six years led to less disability and disease progression in recently diagnosed (≤3 years) and treatment-naïve people with relapsing multiple sclerosis (RMS), compared to those who switched from teriflunomide.In the separate US-based single-arm OLIKOS Phase IIIb study, all clinically stable RMS patients who switched from intravenous anti-CD20 therapy to Kesimpta showed no new gadolinium-enhancing (Gd+) T1 lesions at 12 months. Data from both studies were presented at the ECTRIMS 2024 Annual Meeting.PelabresibBased on Novartis review of 48-week data from the Phase III MANIFEST-2 study, longer follow-up time is needed to determine, in consultation with Health Authorities, the regulatory path for pelabresib in myelofibrosis. We will continue to follow patients in MANIFEST-2 and evaluate the potential for additional studies to support registration. The 48-week data will be presented at an upcoming medical meeting.XXB750Novartis will not advance further development of XXB750 in resistant hypertension and heart failure, following current scientific assessment and review of available data from early investigational studies.BD&LNovartis, in collaboration with Versant Ventures, established Borealis Biosciences, an independent, discovery-stage biotechnology company focused on developing next-generation RNA-based medicines for kidney diseases. Under the agreement, Novartis has the option to acquire two future development-ready programs to augment its renal portfolio, a strategic area of focus for the company.Novartis entered into a collaboration agreement with Generate: Biomedicines to discover and develop protein therapeutics across multiple disease areas with generative AI. The collaboration will combine Generate’s AI platform with Novartis expertise and capabilities in target biology, biologics development, and clinical development to create novel therapeutics and to accelerate the pace of drug discovery and development. Capital structure and net debt Retaining a good balance between investment in the business, a strong capital structure, and attractive shareholder returns remains a priority. During the first nine months of 2024, Novartis repurchased a total of 52.7 million shares for USD 5.7 billion on the SIX Swiss Exchange second trading line. These purchases included 45.4 million shares (USD 4.8 billion) under the up-to USD 15 billion share buyback announced in July 2023 (with up to USD 7.9 billion still to be executed). In addition, 7.3 million shares (USD 0.9 billion) were repurchased to mitigate dilution related to participation plans of associates, with the remainder of repurchases for this purpose to be executed in Q4 2024. Further, 1.1 million shares (for an equity value of USD 0.1 billion) were repurchased from associates. In the same period, 9.1 million shares (for an equity value of USD 0.8 billion) were delivered as a result of share deliveries related to participation plans of associates. Consequently, the total number of shares outstanding decreased by 44.7 million versus December 31, 2023. These treasury share transactions resulted in an equity decrease of USD 5.0 billion and a net cash outflow of USD 5.5 billion. As of September 30, 2024, net debt increased to USD 16.3 billion compared to USD 10.2 billion net debt at December 31, 2023. The increase was mainly due to the free cash flow of USD 12.6 billion being more than offset by the USD 7.6 billion annual dividend payment, net cash outflow for M&A / intangible assets transactions of USD 5.5 billion, and cash outflow for treasury share transactions of USD 5.5 billion. As of Q3 2024, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings. 2024 outlook Barring unforeseen events; growth vs prior year in ccPrevious guidanceNet salesExpected to grow low double-digit(from high single to low double-digit)Core operating incomeExpected to grow high teens(from mid to high teens) Key assumptions: We assume Tasigna, Promacta and Entresto US generic entry mid-2025 for forecasting purposes Foreign exchange impact If late-October exchange rates prevail for the remainder of 2024, the foreign exchange impact for the year would be negative 1 percentage point on net sales and negative 3 to negative 4 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website. Key figures1 Continuing operations2Q3 2024Q3 2023% change 9M 20249M 2023% change USD m USD mUSDcc USD m USD mUSDccNet sales12 82311 782910 37 16434 017911Operating income3 6271 762106123 11 0147 1875361As a % of sales28.315.0 29.621.1 Net income3 1851 513111121 9 1195 9345462EPS (USD)1.580.73116127 4.502.845867Cash flows from operating activities6 2865 30419 13 42611 67315 Non-IFRS measures Free cash flow 5 9655 04318 12 61811 01915 Core operating income5 1454 4051720 14 63512 5511720As a % of sales40.137.4 39.436.9 Core net income4 1333 5851517 11 82210 3201518Core EPS (USD)2.061.741820 5.834.951821 Discontinued operations2Q3 2024Q3 2023% change 9M 20249M 2023% change USD m USD mUSDcc USD m USD mUSDccNet sales 2 476nmnm 7 428nmnmOperating (loss)/income -86nmnm 265nmnmAs a % of sales -3.5 3.6 Net income 250nmnm 440nmnmNon-IFRS measures Core operating income 250nmnm 1 185nmnmAs a % of sales 10.1 16.0 Total CompanyQ3 2024Q3 2023% change 9M 20249M 2023% change USD m USD mUSDcc USD m USD mUSDccNet income3 1851 763nmnm 9 1196 374nmnmEPS (USD)1.580.85nmnm 4.503.05nmnmCash flows from operating activities6 2865 378nmnm 13 42611 911nmnmNon-IFRS measures Free cash flow 5 9655 043nmnm 12 61811 038nmnmCore net income4 1333 784nmnm 11 82211 209nmnmCore EPS (USD)2.061.83nmnm 5.835.37nmnm nm=not meaningful 1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 46 of the Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year.2. As defined on page 35 of the Interim Financial Report, Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities and Discontinued operations include operational results from the Sandoz business. Detailed financial results accompanying this press release are included in the Interim Financial Report at the link below:https://ml-eu.globenewswire.com/resource/download/6504f5e3-a14c-43ba-8b72-44dcc5a45156/ DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “may,” “can,” “will,” “continue,” “ongoing,” “grow,” “launch,” “expect,” “deliver,” “focus,” “address,” “accelerate,” “deliver,” “remain,” “scaling,” “guidance,” “outlook,” “long-term,” “priority,” “potential,” “momentum,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding results of ongoing clinical trials; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings; or by discussions of strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing; or regarding our capital structure; or regarding the consequences of the spin-off of Sandoz and our transformation into a “pure-play” innovative medicines company. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. Neither can there be any guarantee expected benefits or synergies from the transactions described in this press release will be achieved in the expected timeframe, or at all. In particular, our expectations could be affected by, among other things: uncertainties regarding the success of key products, commercial priorities and strategy; uncertainties in the research and development of new products, including clinical trial results and additional analysis of existing clinical data; uncertainties regarding the use of new and disruptive technologies, including artificial intelligence; global trends toward healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; our ability to realize the intended benefits of our separation of Sandoz into a new publicly traded standalone company; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; uncertainties in the development or adoption of potentially transformational digital technologies and business models; uncertainties surrounding the implementation of our new IT projects and systems; uncertainties regarding potential significant breaches of information security or disruptions of our information technology systems; uncertainties regarding actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this press release; safety, quality, data integrity, or manufacturing issues; our performance on and ability to comply with environmental, social and governance measures and requirements; major political, macroeconomic and business developments, including impact of the war in certain parts of the world; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and other risks and factors referred to in Novartis AG’s most recently filed Form 20-F and in subsequent reports filed with, or furnished to, the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. All product names appearing in italics are trademarks owned by or licensed to Novartis. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. Novartis will conduct a conference call with investors to discuss this news release today at 14:00 Central European time and 9:00 Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Novartis website. A replay will be available after the live webcast by visiting https://www.novartis.com/investors/event-calendar. Detailed financial results accompanying this press release are included in the condensed interim financial report at the link below. Additional information is provided on our business and pipeline of selected compounds in late-stage development. A copy of today's earnings call presentation can be found at https://www.novartis.com/investors/event-calendar. Important dates November 20-21, 2024Meet Novartis Management 2024 (London, UK)December 9, 2024Impact & Sustainability annual investor event (virtual)January 31, 2025 Fourth quarter & full year 2024 results Please find full media release in English attached and on the following link:Media Release (PDF) Further language version is available through the following link: German version is available through the following link:Medienmitteilung (PDF)

– Based on a Review of Unblinded Data, an Independent Data Monitoring Committee (IDMC) Confirmed that Predetermined Futility Criteria Have Not Been Met – – IDMC Also Recommended Continuing Trial without Changes, Including no Need for a Potential Upsizing – – ENSURE Program Remains on Track to be Completed in 2026 – – Webcast to be Held Today, October 22, at 8:00 am ET – NEW YORK, Oct. 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 a positive outcome of the non-binding, interim futility analysis of its phase 3 ENSURE program, investigating lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned. "While Immunic remains blinded to all data, the IDMC's favorable recommendations in this interim analysis corroborate our initial assumptions for the design, powering and relapse rate of the twin phase 3 trials of vidofludimus calcium in RMS, and suggest that they are in line with the data observed so far," stated Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic. "In particular, the planned sample size seems appropriate to address the primary endpoint of time to first relapse. As the IDMC recommends, we are continuing the ENSURE trials unchanged, with completion expected in 2026." "I am particularly excited about the positive outcome of the interim analysis of our phase 3 ENSURE trials, marking the successful achievement of a critical milestone for the program," added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We are confident in vidofludimus calcium's potential to transform the oral MS market and continue to believe that the phase 3 program provides a clear and straightforward path towards seeking potential regulatory approval in RMS. Our next clinical milestone for vidofludimus calcium is the top-line readout of our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS), which we expect to release in April of next year. If this data set continues to show a neuroprotective effect for vidofludimus calcium, we believe our drug may be positioned as first-in-class oral treatment option for PMS, a form of MS with highest unmet medical needs." The interim futility analysis of the phase 3 ENSURE program was performed by an unblinded IDMC and based on a pre-specified assessment after approximately half of the planned first relapse events occurred in the double-blind treatment periods of each of the twin ENSURE-1 and ENSURE-2 trials. The analysis was intended to inform potential sample size adjustment and help prevent the final study readout from occurring before sufficient events have been achieved. The unblinded IDMC was asked to make two decisions: The first question, as to whether the trials are futile, was answered by the IDMC with "futility criteria have not been met." The second question, as to whether the sample size in each trial should be increased, was answered by the IDMC with "continue as planned." Both decisions were based on the conditional power of the trials at the time of the interim analysis. Immunic has remained blinded during the interim analysis and has not seen any of the data available to the IDMC to make their recommendations. The ongoing ENSURE program comprises two identical multicenter, randomized, double-blind phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients. Each of the trials, titled ENSURE-1 and ENSURE-2, is expected to enroll approximately 1,050 adult patients with active RMS at more than 100 sites in more than 15 countries, including the United States, India and countries in Latin America, Central and Eastern Europe. Patients are being randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo and the primary endpoint for both trials is time to first relapse up to 72 weeks. Key secondary endpoints include time to confirmed disability worsening based on Expanded Disability Status Scale (EDSS) disability progression, volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and percentage of whole brain volume change, grey matter volume and white matter volume. As previously reported, completion of ENSURE-1 is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected in the second half of 2026. 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 Vidofludimus Calcium (IMU-838) Vidofludimus calcium is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor related 1 (Nurr1), which is associated with direct neuroprotective properties. Additionally, vidofludimus calcium is a highly selective inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and anti-viral effects of vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. To date, vidofludimus calcium has been tested in more than 1,800 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country. 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; announcements regarding the positive outcomes of the interim analysis of the phase 3 ENSURE trials; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; 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, 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] 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

基因检测,MRD，CTC....确诊癌症后究竟应该做哪些检测？ 近年来，随着生物技术在医学领域的快速发展和人们在细胞分子水平对肿瘤发病机制认识的深入，肿瘤的诊断和治疗已经由经验诊疗时期迈进精准诊疗新时代。从传统病理分型到基于肿瘤及其微环境的基因组学、转录组学、蛋白质组学、表观基因组学和免疫学表征，目前国际和国内有了多种精准检测手段指导癌症治疗，为癌症患者提供了更为个性化、量体裁衣式的干预方案，获得更好的治疗效果，大大降低癌症的发生率和死亡率。 那么跟癌症相关的精准检测都有哪些呢？全球肿瘤医生网医学部将肿瘤为大家详细整理了目前肿瘤精准诊疗检测的常见方法，给病友们参考。（大家如果已经做了相关的检测，也可以提交至全球肿瘤医生网医学部进行解读） 一、肿瘤家属及高危人群 ：遗传性肿瘤基因检测 肿瘤的发生是遗传因素和环境因素共同作用的结果。因此，一些癌症确实存有家族遗传聚集现象。一方面家属与患者拥有的生活方式、饮食习惯及环境基本是一致的，甚至可以说是共同享有。另一方面，遗传性肿瘤约占全部肿瘤的1/10。影响肿瘤遗传的易感因素主要有胚系突变、遗传多态性及遗传变异。 国内外权威医学研究表明，遗传性肿瘤具有家族聚集特征 约 5%-10% 的恶性肿瘤 为遗传性肿瘤 50% 的概率会遗传给子女 其中，发生 胚系突变 的人群中， 发生肿瘤的风险要比普通人群 高数十倍或数百 倍！ 男性、女性中13类癌症与遗传性基因相关 遗传性基因检测可以帮助我们了解是否携带某种癌症相关的基因有害突变;通过对相关基因的综合评估，得出某种癌症的患病风险;指导相关突变基因携带者进行癌症风险管理。研究人员将特定基因的突变与 50 多种遗传性癌症综合征相关联，这些疾病可能使个体易患某些癌症。下表为可用于基因检测的最常见的遗传性癌症综合征，每种综合征中突变的基因，以及最常与这些综合征相关的癌症类型。 二、体内出现异常结节是癌症来了？ 癌症超早期诊断三大检测技术 相信有很多病友都遇到这种“尴尬”，体内出现微小结节，因为太小无法穿刺活检确诊，临床医生只能让继续观察，等病灶足够大的时候才能确诊！ 从体内出现第一个癌变细胞，到形成一个米粒大小的病灶需要10年左右，这是最关键的癌前阶段，是治疗的黄金期，如果能在此时发现并干预，治愈几率可达到近100%。然而当肿瘤小于0.5cm时，传统的检查很难确诊，因此，一旦发现确切的病灶，往往为时已晚，肿瘤已经到了中晚期，大大降低了临床“治愈”几率。 近年来，血液检测的发展，完美的弥补了影像学和组织学的诊断“盲点”，对于临床诊断具有非常大的帮助，使得我们能够提前对微小肿瘤病灶进行干预。目前，有三项检测可用于超早期肿瘤的检测。 01 ctDNA（循环肿瘤DNA） 循环肿瘤DNA（ctDNA）来自于肿瘤细胞因坏死、凋亡或主动分泌等原因释放的DNA片段，通过检测ctDNA能够在早期及癌前阶段发现肿瘤的踪迹，在肿瘤早期或超早期的时候就能够发现基因水平的变化，在癌细胞未形成肿瘤组织前将其捕获。从而达到早筛查，早发现，早诊断及早治疗的目的。适合临床相关指标怀疑癌症但无法确诊的人群。 02 CTC（循环肿瘤细胞） CTC（循环肿瘤细胞）检测可以在肿瘤播散早期发现血液中的CTC，比传统CT检查能提早2-6个月观察到肿瘤变化，发出预警信息，发现早期癌症，也能够及时有针对性地指导患者用药，有效控制肿瘤进展及转移。原文链接：“窥血”识癌防复发：肿瘤“捕手”新检测技术竟能从血液中对癌症种子下手！ 03 免疫功能33项监测 每个人体内的免疫细胞水平和状态都是不同的，当免疫监视功能由于各种原因被消弱时，无法识别和消灭体内的癌细胞，就容易发生肿瘤；如果机体免疫监视功能被削弱，人类的肿瘤发病率会大大的提高。免疫功能33项实时检测是通过抽血分析淋巴细胞亚群来检测细胞免疫和体液免疫功能，能够全面反映机体当前的免疫功能、状态和平衡水平，并可以辅助诊断如自身免疫病、免疫缺陷病、恶性肿瘤、血液病、变态反应性疾病等，分析发病机制，观察疗效及检测预后有重要意义。为什么癌症患者都需要做免疫功能实时监测？ 三、个体化量身定制诊疗方案--癌症精准治疗三大检测 随着全球对癌症研究的不断深入，越来越多的精准抗癌新药和新技术问世，足以控制晚期癌症的进展，提高生活质量，延长寿命，甚至让很多生命即将终结的晚期癌症患者奇迹重生！这些先进的治疗手段让癌症治疗突破了过去仅根据经验或病理分型治疗造成的低治愈率的窘境，通过以下更精准的检测，肿瘤患者将获得更好的治疗方案。 01 基因检测 基因检测已成为癌症精准治疗的标准动作！科学家已经鉴定出一组特定的肿瘤DNA变化，因此肿瘤患者不再是仅根据病理分型选择化疗药物，而可以通过基因检测，发现突变位点，为患者制定更加有效，副作用更小的化疗，靶向，免疫治疗方案，以及家族癌症风险评估。 不得不说，一个患者一套方案的个体化诊疗时代已经到来。以下是欧洲医学肿瘤学会（ESMO）最新发布的首部含金量超高的转移性癌症患者二代测序指南，明确指出了各类癌症应检测的靶点，如果大家做了检测，可以将报告发送至全球肿瘤医生网医学部（4006667998）进行解读，匹配可用的抗癌新药。 分子靶点临床可行性量表（ESCAT） 晚期非鳞状非小细胞肺癌 转移性乳腺癌 结直肠癌 前列腺癌 转移性胃癌 胰腺导管腺癌 晚期肝细胞癌 晚期胆管癌 02 生物标记物检测 除了靶向免疫治疗药物，近年来，过继性细胞免疫疗法在实体瘤的特异性靶点，增殖、细胞因子释放等方面已经有了明显改进，越来越多的临床试验开始尝试将细胞疗法用于实体瘤的治疗，研究人员发现了众多可用于实体瘤的生物标记物靶点，晚期实体肿瘤患者迎来更多的新希望！ 想尝试前沿疗法的病友可提交资料至全球肿瘤医生网医学部申请（4006667998）。 Claudin18.2：用于胃癌，胰腺癌等。 间皮素（mesothelin）：用于治疗间皮瘤、胰腺癌、卵巢癌、肺癌； CEA：用于治疗肺癌、结肠癌、胃癌、乳腺癌和胰腺癌； MUC-1：用于治疗肝癌、肺癌、胰腺癌、结肠癌、胃癌; GPC3：用于治疗肝癌; EGFＲvII：用于治疗神经胶质瘤、头颈部肿瘤； B7-H3：用于治疗尤文肉瘤、横纹肌肉瘤、肾母细胞瘤、神经母细胞瘤和髓母细胞瘤以及特别难以治疗的脑干肿瘤（DIPG）； PSMA：用于前列腺癌等 03 新一代药物遴选技术 目前，利用患者自体的肿瘤进行药物筛选，从而帮助制定个体化的治疗方案，是最为行之有效的手段之一。 新一代药物遴选技术，通过手术从癌症病人身上提取少样的肿瘤细胞样本，在实验室中模拟肿瘤细胞体内的营养需求和肿瘤组织中的胞外微环境，实现对肿瘤细胞的快速扩增，并充分保持了细胞的原代特征。进而对肿瘤细胞进行药物敏感性分析，进行高通量药物筛选，所获得的实验结果与体内用药的致性具有良好的相关性，从而指导医院实现精准用药。 四、远离癌症！癌症治疗后监测复发的三大检测 有很多癌症患者的手术很成功，但最后却死在了复发和转移，据统计，有70%·80%的癌症患者是死于复发、转移！那么，癌症患者手术及治疗后有哪些检测手段能及时监测身体状况，避免癌症复发转移的出现，真正实现临床“治愈”呢？ 01 MRD检测 血液检测的动态随访和监测，可以更为精准地发现患者术后复发的趋势和苗头，从而给了我们主动出击、通过辅助治疗预防复发的策略选择，而不仅仅只是守株待兔，等到复发之后再应对。 分子残留病变（MRD），指的是经过治疗后，传统影像学(包括 PET/CT)或实验室方法不能发现，但通过液体活检发现的癌来源分子异常，代表着肿瘤的持续存在和临床进展可能。MRD 是导致肿瘤复发的主要原因之一! MRD检测能够在短时间内评估患者治疗后的肿瘤残留情况，有助于临床医生了解治疗效果。通过检测体内残留的少量癌细胞（这些癌细胞对治疗无反应或耐药），医生可以判断治疗是否彻底，从而优化后续的治疗方案，对于预测癌症复发风险具有重要意义。 02 肠道菌群检测 研究人员发现，每个人体内的菌群数量，种类都是完全不同的。而正常人体内的肠道菌群和癌症患者体内的菌群更是天壤之别。 值得注意的是，癌症疗法（例如化学疗法和放射疗法）可能会破坏肠道菌群。科学家正在研究益生菌是否可以帮助接受癌症治疗的人重新平衡菌群。例如，一些研究表明，益生菌可以减少接受化疗的肺癌患者和接受结肠癌手术的人的腹泻。 肠道菌群检测是精准检测之—，基于二代高通量基因测序技术（16SrDNA）精确反应人体肠道菌群种类、数量、结构，识别疾病风险及健康水平。通过肠道菌群检测的检测可以有效评估大部分的慢病风险和进展，甚至可提前对部分疾病进行预警。同时可以针对癌症患者人群，精确反映肠道菌群结构以及菌群平衡情况，个性化定制养菌、种菌的解决方案，平衡免疫系统，达到改善过敏及自体免疫、提升免疫细胞灭癌能力、防癌抗癌等功能。 因此，肿瘤患者在治疗期间和结束后应进行肠道菌群的检测，看看是否存在肠道菌群失衡，及时进行纠正和调整， 大家可以致电全球肿瘤医生网医学部了解肠道菌群检测及调节方式及获得定制化肠菌调节方案。 03 营养功能检测 根据中国抗癌协会肿瘤营养与知识治疗专委会一项3万多人的调查研究表示，我国发现将近三分之二的患者存在不同程度的营养不良。营养不良会导致患者对治疗耐受性降低、刀口不容易愈合、术后容易发生感染等，直接降低了患者的生活质量，影响治疗效果，甚至生存期因此大打折扣！正常的营养功能是维持机体免疫，抵抗癌症的基础。因此，肿瘤患者应该实时监测自己的营养功能是否正常，一旦发现异常，应该及时干预，进行相应营养支持治疗。 以上适用于各类人群的精准检测手段只是目前众多研发热点中的一小部分，相信更多的创新技术正在路上，终将让癌症无处遁形！