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INmune Bio(INMB) - 2025 Q1 - Quarterly Results
2025-05-08 20:18
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 ...
INmune Bio(INMB) - 2025 Q1 - Quarterly Report
2025-05-08 20:15
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)
INmune Bio Inc. Announces First Quarter 2025 Results and Provides Business Update
Globenewswire· 2025-05-08 20:10
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]
INmune Bio Inc. to Report First Quarter 2025 Financial Results and Provide Corporate Update on Thursday, May 8th
GlobeNewswire News Room· 2025-05-05 11:00
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]
INmune Bio Receives Favorable Patentability Opinion for CORDStrom™ Platform Technology
Newsfilter· 2025-04-16 11:00
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 ...
INmune Bio Partners with Cell and Gene Therapy Catapult to Scale Up CORDStrom™ Manufacturing for Commercial Readiness
Newsfilter· 2025-04-14 12:00
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 ...
INmune Bio Inc. Presents Baseline Demographics and Disease Profiles of Participants in the MINDFuL Phase II Study
Globenewswire· 2025-04-01 11:00
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 ...
INmune Bio(INMB) - 2024 Q4 - Earnings Call Transcript
2025-03-28 00:15
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]
INmune Bio(INMB) - 2024 Q4 - Annual Results
2025-03-27 20:30
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 ...
INmune Bio(INMB) - 2024 Q4 - Earnings Call Transcript
2025-03-27 20:30
INmune Bio (INMB) Q4 2024 Earnings Call March 27, 2025 04:30 PM ET Company Participants David Moss - Chief Financial OfficerRaymond Tesi - CEO & ChairmanGeorge Farmer - Managing DirectorMark Lowdell - Chief Scientific Officer & Chief Manufacturing OfficerCJ Barnum - Head of NeuroscienceDenis Reznik - Senior Equity Research AssociateElemer Piros - Senior Managing Director Conference Call Participants Thomas Shrader - Equity Research AnalystJames Molloy - Managing Director, Senior Biotechnology & Specialty Ph ...