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)

Conference Call Today at 4:30pm ETBOCA 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 Highlights (XPro™): Top-line results from the MINDFuL phase 2 trial in Alzheimer’s expected in the secon ...

Boca Raton, Florida, US, April 16, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ:INMB), a clinical-stage biotechnology company targeting inflammation and immunology through the innate immune system, today announced a major intellectual property milestone with respect to its next-generation mesenchymal stromal cell (MSC) product, CORDStrom™. The United States Patent and Trademark Office (USPTO), acting as the International Search Authority, has issued a favorable written opinion on all claims in INmune B ...

Stevenage, UK, and Boca Raton, Florida, US, April 14, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ:INMB) a clinical-stage biotechnology company targeting inflammation and immunology through the innate immune system has partnered with the Cell and Gene Therapy Catapult (CGT Catapult) to establish large-scale, commercial-ready manufacturing for its cell therapy platforms. CGT Catapult is an independent technology and innovation organization specializing in the advancement of the cell and gene therapy indu ...

MINDFuL Phase II Blinded, Randomized, Placebo-Controlled Data Anticipated June 2025 Poster #294: ALZHEIMER'S DISEASE (AD) AND IMMUNE DYSFUNCTION: BASELINE DEMOGRAPHICS AND DISEASE CHARACTERISTICS FROM A PHASE-2 STUDY OF XPRO1595 IN EARLY AD Topline results of the MINDFuL trial will be reported in June 2025. About INmune Bio Inc. INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INm ...

Financial Data and Key Metrics Changes - INmune Bio raised $29.9 million from the sale of common stock and warrants in 2024, issuing a total of 4,145,978 shares and warrants for 3,898,852 shares [37][38] - The net loss attributable to common stockholders for the year ended December 31, 2024, was approximately $42.1 million, compared to approximately $30 million for 2023 [40] - Research and development expenses totaled approximately $33.2 million for 2024, up from approximately $20.3 million in 2023 [40] - Cash and cash equivalents at December 31, 2024, were approximately $20.9 million, with an additional $5.4 million raised since year-end [41] Business Line Data and Key Metrics Changes - The ADO2 trial for Alzheimer's disease is expected to announce top-line data in less than 100 days, focusing on neuroinflammation as a primary driver of the disease [8][14] - The INmune platform has pivoted to target solid tumors, with ongoing trials for castrate-resistant metastatic prostate cancer [17][18] - CORDStrom, a new therapeutic platform, is positioned to address systemic disease modification for RDEB, differentiating itself from local wound management therapies [22][24] Market Data and Key Metrics Changes - The ADO2 trial enrolled 208 patients across eight countries, with a focus on those with neuroinflammation driving their Alzheimer's disease [15] - The CaRe PC trial for prostate cancer is progressing, with completion of dosing in the Phase 1 part and ongoing Phase 2 dosing expected to complete by 2025 [18][43] Company Strategy and Development Direction - INmune Bio aims to challenge the amyloid-centric paradigm of Alzheimer's treatment by focusing on neuroinflammation [14][33] - The company is committed to advancing its three therapeutic platforms, with a focus on achieving regulatory milestones and potential commercialization [36][45] - The management emphasizes a precision medicine approach in clinical trials, particularly in the ADO2 trial [10][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming results from the ADO2 trial, viewing it as a potential catalyst for a paradigm shift in Alzheimer's treatment [34][35] - The company believes that addressing neuroinflammation could have broader implications for various CNS diseases [35] - Management highlighted the importance of safety in treating elderly patients with Alzheimer's, noting no significant adverse events reported thus far [31] Other Important Information - The company plans to file a BLA for CORDStrom in the first quarter of 2026, which would mark its first market therapeutic [44][112] - Management is focused on ensuring the quality of regulatory submissions to facilitate successful approvals [113] Q&A Session Summary Question: Is the 12-month open label trial for RDEB required for filing? - Management indicated that they believe the current data is adequate for a BLA submission, but the FDA will ultimately decide [50][51] Question: Will EMACC and CDR results be released at the same time? - Management confirmed that both EMACC and CDR results will be available at the time of data release [56][60] Question: Are there any dropouts in the EXPAREL Phase 2 trial? - Management reported that dropouts are within expected ranges, primarily due to typical issues associated with elderly patients [86] Question: How does the company plan to commercialize CORDStrom? - Management aims to move towards commercialization independently but may seek a partner closer to the launch [93] Question: Will the BLA for CORDStrom be filed in the UK and US? - Management confirmed that they expect to have all necessary data ready for filing in both regions by early 2026 [101][102]

Exhibit 99.1 CORDStrom™ Platform INKmune® Platform: 2 ● Reported results of a double-blinded, randomized, placebo-controlled, cross-over study, known as "MissionEB," investigating CORDStrom™ for treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) in pediatric patients, which evidenced a favorable benefit-risk profile. ● FDA granted CORDStrom™ a Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) for treatment of epidermolysis bullosa (EB). ● Data from the MissionEB trial s ...