Core Insights - INmune Bio, Inc. (NASDAQ: INMB) reported Q1 2025 business and financial results on May 8th, 2025, surpassing analyst estimates [1] - The company is on track to share results of its ongoing projects, indicating progress in its research and development efforts [1] Financial Performance - The financial results for Q1 2025 showed a positive trend, with the company beating analyst expectations [1] Research and Development - INmune Bio focuses on novel Cell & Gene Therapies (CGT) aimed at addressing various clinical needs, showcasing its commitment to innovation in the biotechnology sector [1]

Core Insights - INmune Bio Inc. is a clinical-stage biotechnology company focused on inflammation and immunology through the innate immune system [1][2] - The company will present at the 2025 RBC Capital Markets Global Healthcare Conference on May 20-21, 2025 [1][2] Company Overview - INmune Bio Inc. is publicly traded on NASDAQ under the ticker INMB [2] - The company has three main product platforms: - Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform, targeting Mild Alzheimer's disease, Mild Cognitive Impairment, and treatment-resistant depression [2] - Natural Killer Cell Priming Platform, featuring INKmune®, aimed at treating metastatic castration-resistant prostate cancer [2] - CORDStrom™, a proprietary platform using human umbilical cord-derived mesenchymal Stromal/Stem cells, recently completed trials for recessive dystrophic epidermolysis bullosa [2] - The company employs a precision medicine approach for diseases associated with chronic inflammation and cancer [2]

Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for Q1 2025 was approximately $9.7 million, compared to approximately $11 million for the same period in 2024, indicating an improvement [26] - Research and development expenses totaled approximately $7.6 million for Q1 2025, down from approximately $8.7 million in Q1 2024 [26] - General and administrative expenses remained stable at approximately $2.3 million for both Q1 2025 and Q1 2024 [26] - As of March 31, 2025, the company had cash and cash equivalents of approximately $19.3 million, which is expected to fund operations through Q3 2025 [27] Business Line Data and Key Metrics Changes - The company is preparing to report top-line results from the MINDFUL phase two trial in early Alzheimer's disease, expected in mid to late June 2025 [6][27] - The market opportunity for EXPAREL in early Alzheimer's disease has increased to nearly 70% of early AD patients, up from the previously estimated 40% [7][8] - The safety profile of EXPAREL remains excellent, with no reports of adverse events in the ongoing trial [9] Market Data and Key Metrics Changes - The approval of mecanumab in the EU and UK excludes patients with two copies of the APOE4 gene, creating an unmet need for EXPAREL therapy in this subgroup [10][11] - The evolving biomarker landscape in Alzheimer's disease, particularly the significance of p-tau217, is expected to enhance the company's market position [12] Company Strategy and Development Direction - The company is focused on targeting neuroinflammation in Alzheimer's disease, positioning itself as a leader in this area [81][82] - Plans for the Kordstrom program include filing a Biologics License Application (BLA) in 2026 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) [17][24] - The company aims to transition manufacturing processes to optimize production for both Kordstrom and Inkmune, ensuring cost-effectiveness and regulatory compliance [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming MINDFUL trial results, believing they will significantly impact the treatment landscape for early Alzheimer's disease [16][81] - The company is optimistic about the regulatory environment for rare disease treatments, particularly following recent FDA comments [18][24] Other Important Information - The company has successfully transitioned its drug supply logistics for Inkmune to a US-based contractor, Cryoport, to ensure trial completion [21] - The company is also preparing for an IND submission for Kordstrom in the US, with manufacturing of a new batch of products using US-approved cord donors starting soon [73] Q&A Session Summary Question: Can you walk us through the next steps for the program assuming a positive readout in June? - Management indicated that they would defer specific timelines until after the FDA meeting, aiming to move quickly to open sites and enroll patients [32][33] Question: Can you comment on the FDA review team for your program? - Management believes that the FDA has remained on track and that the review team is stable, although they cannot predict future outcomes [36] Question: How do you think investors will react if EMAC hits but CDR is equivocal? - Management emphasized that EMAC is the primary driver for cognitive changes, and they expect correlations with CDR, which is a more blunt instrument [46][49] Question: Are APOE4 patients inherently inflammatory? - Management confirmed that APOE4 carriers tend to have earlier onset and faster progression of Alzheimer's disease, indicating a link to inflammation [62] Question: Are you still on track to initiate the twelve-month open-label trial for Cordstrom mid this year? - Management confirmed they are following FDA guidance and expect to submit an IND late this year, with plans for a follow-on trial in the US [73][74]

Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for Q1 2025 was approximately $9.7 million, compared to approximately $11 million for the same period in 2024, indicating an improvement [26] - Research and development expenses totaled approximately $7.6 million for Q1 2025, down from approximately $8.7 million in Q1 2024 [26] - General and administrative expenses remained stable at approximately $2.3 million for both Q1 2025 and Q1 2024 [26] - As of March 31, 2025, the company had cash and cash equivalents of approximately $19.3 million, which is expected to fund operations through Q3 2025 [27] Business Line Data and Key Metrics Changes - The company is preparing to report top-line results from the MINDFUL phase two trial in early Alzheimer's disease, expected in mid to late June 2025 [6][16] - The market opportunity for EXPAREL in early Alzheimer's disease has increased to nearly 70% of early AD patients, up from the previously estimated 40% [7][8] - The safety profile of EXPAREL remains excellent, with no adverse events reported in the ongoing trial [9] Market Data and Key Metrics Changes - The approval of mecanumab in the EU and UK excludes patients with two copies of the APOE4 gene, creating an unmet need for EXPAREL therapy in this subgroup [10][11] - The evolving biomarker landscape in Alzheimer's disease, particularly the significance of p tau 217 levels, is expected to enhance the therapeutic response measurement in patients [12] Company Strategy and Development Direction - The company aims to position itself as a leader in targeting immune dysfunction that drives neuroinflammation in Alzheimer's disease [83][84] - The upcoming BLA filing for Cordstrom in 2026 is part of the company's strategy to address rare diseases, specifically recessive dystrophic epidermolysis bullosa (RDEB) [17][24] - The company is transitioning its manufacturing processes to optimize production for both Inkmune and Cordstrom, ensuring cost-effective scalability [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming MINDFUL trial results, which are anticipated to significantly impact the treatment landscape for early Alzheimer's disease [16][84] - The company is closely monitoring FDA developments and believes that the regulatory environment remains favorable for drug development [36] Other Important Information - The company raised approximately $2.1 million from the sale of common stock after the end of the quarter [27] - The company is also planning to initiate a phase two trial of EXPAREL in patients with treatment-resistant depression once NIH funding is secured [28] Q&A Session Summary Question: Can you walk us through the next steps for the program assuming a positive readout in June? - Management indicated that they would defer specific timelines until after the results and discussions with the FDA [32] Question: Can you comment on the turnover at the FDA and the review team for your program? - Management believes that the FDA remains on track and that the review team is stable [36] Question: How do you think investors will react if EMAC hits but CDR is equivocal? - Management emphasized that EMAC is the primary driver for cognitive changes and that they expect correlations with CDR [46][50] Question: What is the expected reduction in CDR for a trial of this size? - Management expressed confidence in their power calculations based on previous trials and the quality of their patient population [62][70] Question: Are you still on track to initiate the twelve-month open-label trial for Cordstrom? - Management confirmed that they are following FDA guidance and expect to submit an IND later this year [74]

Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for Q1 2025 was approximately $9.7 million, compared to approximately $11 million for the same period in 2024, indicating an improvement [27] - Research and development expenses totaled approximately $7.6 million for Q1 2025, down from approximately $8.7 million in Q1 2024 [27] - General and administrative expenses remained stable at approximately $2.3 million for both Q1 2025 and Q1 2024 [27] - As of March 31, 2025, the company had cash and cash equivalents of approximately $19.3 million, sufficient to fund operations through Q3 2025 [28] Business Line Data and Key Metrics Changes - The company is preparing to report top-line results from the MINDFUL trial, a Phase 2 trial in early Alzheimer's disease, expected in mid to late June 2025 [5][16] - The market opportunity for EXPAREL in early Alzheimer's disease patients has increased to nearly 70%, up from the previously estimated 40% [6][8] - The safety profile of EXPAREL remains strong, with no reports of adverse events in the MINDFUL trial [9] Market Data and Key Metrics Changes - The approval of mecanumab in the EU and UK excludes patients with two copies of the APOE4 gene, creating an unmet need for EXPAREL therapy in this subgroup [10][11] - The evolving biomarker landscape in Alzheimer's disease, particularly the significance of p-tau217, is expected to enhance the company's market position [12] Company Strategy and Development Direction - The company aims to position itself as a leader in targeting immune dysfunction that drives neuroinflammation in Alzheimer's disease [81][82] - Plans to file a Biologics License Application (BLA) for Cordstrom in 2026, with ongoing development for Inkmune in prostate cancer [17][29] - The company is focused on transitioning manufacturing processes to meet regulatory requirements and maximize production efficiency [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reporting results that could change the care of patients with early Alzheimer's disease, highlighting substantial share ownership by management as alignment with investor interests [16][80] - The company anticipates an end-of-Phase 2 meeting with the FDA in Q4 2026 to discuss the design of a Phase 3 trial [29] Other Important Information - The company has successfully transitioned its drug supply logistics for Inkmune to a US contractor, ensuring readiness for trial completion [21] - The FDA has indicated a willingness to expedite the approval process for rare disease treatments, which bodes well for Cordstrom [18] Q&A Session Summary Question: What are the next steps for the program assuming a positive readout in June? - Management indicated that they would defer specific timelines until after the results and discussions with the FDA [35] Question: Can you comment on the turnover at the FDA and the receptivity at the ADPD conference? - Management believes the FDA remains on track and noted positive feedback from the ADPD conference regarding their approach to measuring cognition [39][44] Question: How many APOE homozygous patients are in the trial? - The trial includes approximately 9% of APOE homozygous patients, which is consistent with other studies [53] Question: What is the expected reduction in CDR for the trial? - Management expressed confidence in their power calculations based on previous studies, suggesting they are well-positioned to achieve statistically significant results [62] Question: Are you still on track to initiate the open-label trial for Cordstrom? - The company is following FDA guidance and expects to submit an IND later this year, with plans for a follow-on trial in the US [73]

Exhibit 99.1 INmune Bio Inc. Announces First Quarter 2025 Results and Provides Business Update Conference Call Today at 4:30pm ET BOCA RATON, Fla., May 08, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical- stage biotechnology company targeting inflammation and immunology through the innate immune system, today announces its financial results for the quarter ended March 31, 2025 and provides a business update. Q1 2025 and Recent Corporate Highlights DN-TNF Platform Highligh ...

PART I – FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company reported a reduced net loss of $9.7 million for Q1 2025, but faces going concern uncertainty due to insufficient cash and reliance on capital raises [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $37.8 million by March 31, 2025, driven by reduced cash, while liabilities slightly rose and equity declined Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $19,337 | $20,922 | | TOTAL CURRENT ASSETS | $20,960 | $22,662 | | TOTAL ASSETS | $37,801 | $39,562 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | TOTAL CURRENT LIABILITIES | $7,927 | $7,221 | | TOTAL LIABILITIES | $8,128 | $7,465 | | TOTAL STOCKHOLDERS' EQUITY | $29,673 | $32,097 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $37,801 | $39,562 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss decreased to $9.7 million in Q1 2025, primarily due to a reduction in research and development expenses Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | REVENUE | $50 | $14 | | General and administrative | $2,316 | $2,338 | | Research and development | $7,639 | $8,693 | | Total operating expenses | $9,955 | $11,031 | | LOSS FROM OPERATIONS | ($9,905) | ($11,017) | | NET LOSS | ($9,739) | ($11,025) | | Net loss per common share – basic and diluted | ($0.43) | ($0.61) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating cash outflow decreased to $6.8 million, while financing activities provided $5.3 million, ending the quarter with $19.3 million cash Condensed Consolidated Statements of Cash Flows (in thousands) | | For the Three Months Ended March 31, 2025 | For the Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($6,824) | ($7,476) | | Net provided by (used in) financing activities | $5,274 | ($2,500) | | NET DECREASE IN CASH AND CASH EQUIVALENTS | ($1,585) | ($9,846) | | CASH AND CASH EQUIVALENTS AT END OF PERIOD | $19,337 | $26,002 | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's product platforms, a significant going concern warning, and recent capital raises and manufacturing commitments - The company is a clinical-stage biotech focused on three product platforms: DN-TNF (XPro for Alzheimer's/Depression), CORDStrom (for RDEB), and INKmune (for cancer)[27](index=27&type=chunk) - There is **substantial doubt** about the Company's ability to continue as a going concern due to significant losses, negative cash flows, and insufficient liquidity to sustain operations for the next year[29](index=29&type=chunk) - In Q1 2025, the company sold **649,860 shares** of common stock under its ATM program, raising net proceeds of approximately **$5.3 million**[84](index=84&type=chunk) - Subsequent to quarter end, from April 1 to May 8, 2025, the company sold an additional **279,966 shares** for net proceeds of **$2.1 million** through its ATM program[97](index=97&type=chunk) - In April 2025, a subsidiary entered into a two-year lease for manufacturing space in the UK, with commitments of a **$0.5 million deposit**, **$0.2 million upfront payment**, and minimum payments of **$1.3 million** in year one and **$2.6 million** in year two[98](index=98&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical program progress, a reduced net loss driven by lower R&D, and reiterates going concern uncertainty due to insufficient liquidity [Description of Business](index=20&type=section&id=Description%20of%20Business) The company focuses on developing treatments for innate immune system dysfunction, with key clinical programs in Alzheimer's, RDEB, and cancer progressing - **XPro for Alzheimer's Disease (AD)** has completed enrollment in its Phase II trial, with data expected in June. The company plans to start a pivotal Phase III trial after an end-of-phase II meeting with the FDA[101](index=101&type=chunk)[106](index=106&type=chunk) - **CORDStrom for RDEB** has completed a pivotal trial, and the company plans to file a Biologics License Application (BLA) with the FDA in the first half of 2026[101](index=101&type=chunk) - The FDA granted CORDStrom **Rare Pediatric Disease Designation (RPDD)** and **Orphan Drug Designation (ODD)**, making it eligible for a Priority Review Voucher (PRV) and seven years of market exclusivity upon approval[116](index=116&type=chunk)[117](index=117&type=chunk) - The **INKmune program** is in an open-label Phase II trial for metastatic castrate-resistant prostate cancer (mCRPC), with the first patient enrolled in December 2023[101](index=101&type=chunk)[119](index=119&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Net loss decreased by $1.3 million to $9.7 million in Q1 2025, primarily driven by a $1.1 million reduction in R&D expenses Results of Operations Comparison (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Revenues | $50 | $14 | $36 | | Research and development | $7,639 | $8,693 | ($1,054) | | General and administrative | $2,316 | $2,338 | ($22) | | Loss from operations | ($9,905) | ($11,017) | $1,112 | | Net loss | ($9,739) | ($11,025) | $1,286 | - The decrease in R&D expenses was largely due to incurring **$1.5 million less** in costs related to the Alzheimer's clinical program as it nears completion, partially offset by higher compensation costs and a smaller R&D rebate[136](index=136&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces substantial doubt about its going concern ability, with $19.3 million cash insufficient for the next year, relying on future financing - The company had cash and cash equivalents of **$19.3 million** as of March 31, 2025[139](index=139&type=chunk) - Recurring net losses and negative cash flows have raised **substantial doubt** about the company's ability to continue as a going concern, as current cash is projected to be insufficient to sustain operations for the next year[143](index=143&type=chunk) - The company is exploring financing strategies including public or private sales of equity, debt financing, collaborations, and licensing arrangements to fund future operations[145](index=145&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) As a 'smaller reporting company,' the company is not required to provide quantitative and qualitative disclosures about market risk - As a 'smaller reporting company,' the Company is **not required** to provide the information for this item[152](index=152&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were **effective**[154](index=154&type=chunk) - There were **no changes** in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[156](index=156&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any pending legal proceedings expected to materially adversely affect its business or financial condition - The company is **not currently a party** to any pending legal proceedings that it believes will have a material adverse effect on its business or financial conditions[158](index=158&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) Disclosure of risk factors is not required for the company as it qualifies as a smaller reporting company - Disclosure of risk factors is **not required** for smaller reporting companies[159](index=159&type=chunk) [Other Information](index=31&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or other non-Rule 10b5-1 trading arrangement during the fiscal quarter[163](index=163&type=chunk) [Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including a license agreement, a loan termination letter, and officer certifications - Filed exhibits include a License Agreement with Great Ormond Street Hospital, a Termination Letter for the loan with Silicon Valley Bank, and officer certifications[164](index=164&type=chunk)

Core Insights - INmune Bio Inc. reported its financial results for Q1 2025, highlighting a net loss of approximately $9.7 million, an improvement from a loss of $11.0 million in Q1 2024 [6][11][21] - The company is advancing its clinical programs, including the MINDFuL phase 2 trial for Alzheimer's and plans to submit a Biologics License Application (BLA) for CORDStrom targeting Recessive Dystrophic Epidermolysis Bullosa (RDEB) [6][14] Financial Results - For the quarter ended March 31, 2025, the company reported revenue of $50,000, compared to $14,000 in the same period of 2024 [21] - Research and development expenses were approximately $7.6 million, down from $8.7 million in Q1 2024 [6][21] - General and administrative expenses remained stable at approximately $2.3 million [11][21] - As of March 31, 2025, cash and cash equivalents totaled approximately $19.3 million, a decrease from $20.9 million at the end of 2024 [11][18] Clinical Developments - Top-line results from the MINDFuL phase 2 trial in Alzheimer's are expected in the second half of June 2025 [6] - The company plans to file a BLA for CORDStrom in early 2026 [6] - The INKmune Phase II trial has been expanded to include veterans with prostate cancer [6] Product Platforms - The XPro™ platform is a next-generation TNF inhibitor currently in clinical trials, targeting neuroinflammation [8][14] - CORDStrom™ is a cell medicine platform utilizing pooled human umbilical cord-derived mesenchymal stromal cells, aimed at treating complex inflammatory diseases [9][10] - INKmune® is designed to prime a patient's NK cells for cancer treatment, currently in trials for metastatic castration-resistant prostate cancer [12][14]

Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system to combat diseases, particularly Alzheimer's Disease [3] - The company operates three product platforms: Dominant-Negative Tumor Necrosis Factor (DN-TNF), Natural Killer Cell Priming Platform, and CORDStrom™ [3] - DN-TNF product candidates are in clinical trials for Mild Alzheimer's disease, Mild Cognitive Impairment, and treatment-resistant depression [3] - INKmune® is designed to prime NK cells to eliminate minimal residual disease in cancer patients and is currently in trials for metastatic castration-resistant prostate cancer [3] - CORDStrom™ is a proprietary platform that recently completed a trial in recessive dystrophic epidermolysis bullosa [3] Upcoming Events - The company will host a conference call on May 8th, 2025, at 4:30 PM EDT to discuss the results for the quarter ended March 31, 2025, and provide a corporate update [1][2] - Participants can join the call by dialing in 5 to 10 minutes before the start time [2] Financial Information - The company is publicly traded on NASDAQ under the ticker INMB [3]

Core Insights - INmune Bio Inc. has achieved a significant intellectual property milestone with its CORDStrom™ product, a next-generation mesenchymal stromal cell (MSC) therapy targeting inflammation and immunology [1][4] - The United States Patent and Trademark Office (USPTO) has issued a favorable written opinion on INmune Bio's international patent application, confirming the novelty and industrial applicability of all claims [2] - CORDStrom™ is designed to provide consistent therapeutic performance across various inflammatory and degenerative diseases, utilizing pooled, culture-expanded human umbilical cord-derived MSCs [3][6] Intellectual Property Developments - The favorable opinion from the USPTO confirms that all claims in the patent application possess novelty, inventive step, and industrial applicability, which are essential for patentability [2] - The patent application, once granted, will provide IP exclusivity for the CORDStrom product platform until at least 2045, with potential extensions [4] - INmune Bio plans to expedite the U.S. national application process through the Patent Prosecution Highway (PPH) program [4] Product and Clinical Development - CORDStrom™ represents an advancement in cell therapy, offering batch-to-batch consistency and tunability for multiple disease indications [4][7] - Recent Phase 2 trial data indicated that CORDStrom™ reduced pain and itch, with early signs of improved skin integrity and disease activity, marking a pivotal step for the MSC platform [5] - The CORDStrom™ platform is designed to create off-the-shelf, allogeneic MSCs that can be produced at low cost and with consistent specifications, independent of donor characteristics [6] Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments that target the innate immune system [8] - The company has three product platforms, including the DN-TNF platform for treating diseases like Alzheimer's and the Natural Killer Cell Priming Platform [8] - CORDStrom™ is positioned as a first systemic therapy for conditions like recessive dystrophic epidermolysis bullosa (RDEB) and can be tailored for specific indications [7]