Ankündigung • May 16
INmune Bio Inc. Publishes Phase 2 MINDFuL Trial Results in NPJ Dementia, Advancing the XPro Platform INmune Bio Inc. announced that results from its Phase 2 MINDFuL trial in Alzheimer’s disease have been published in the peer-reviewed journal NPJ Dementia. The study evaluated the safety, biomarker engagement, and clinical efficacy of XPro (XPro1595, pegipanermin) in patients with mild Alzheimer’s disease characterized by biomarkers of inflammation. In a pre-specified analysis of the protocol-defined Alzheimer’s Disease with inflammation (ADi) subgroup, XPro showed directionally consistent benefit across cognitive, global, functional, behavioral, and biomarker endpoints over 24 weeks, with no amyloid-related imaging abnormalities (ARIA) observed. The publication, titled “XPro1595 in Early Alzheimer’s Disease with Inflammation: Results from the Phase 2 MINDFuL Trial,” discusses how XPro demonstrated consistent positive trends in a pre-specified enriched subpopulation (n=100) with amyloid-beta positivity and two or more inflammation biomarkers (hsCRP, ESR, HbA1c, or APOE e4 allele). The paper further highlights the effect sizes (Cohen’s d) up to 0.27 across cognitive (EMACC, International Shopping List Test), Patient-Reported Outcomes (Goal Attainment), behavioral (Neuropsychiatric Inventory), and biomarker endpoints (pTau217 and GFAP), directionally consistent with an XPro treatment effect. These findings support prioritization of the enriched population in future studies to optimize detection of treatment effects. The trial also supports a biomarker-enriched (inflammation-enriched) strategy designed to improve future trial design and enhance the potential for clinical success, while reinforcing the broader potential of selective sTNF neutralization across inflammation-driven diseases. XPro is a next-generation, dominant-negative protein biologic that acts as a selective inhibitor of soluble tumor necrosis factor (sTNF). Unlike non-selective TNF inhibitors, XPro neutralizes the pathological driver — sTNF signaling through TNFR1 — while preserving transmembrane TNF (tmTNF) and its homeostatic signaling through TNFR2, which is essential for normal immune function, cellular repair, and host defense. By targeting innate immune dysfunction rather than broadly suppressing immune function, XPro is designed to selectively restore immune balance in the central nervous system. XPro (pegipanermin), the lead DN-TNF candidate, is in clinical development in Alzheimer’s disease with inflammation (ADi), with FDA Fast Track designation, and in treatment-resistant depression. New Risk • May 15
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$9.6m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$44.7m market cap). Ankündigung • May 01
INmune Bio Inc. to Report Q1, 2026 Results on May 07, 2026 INmune Bio Inc. announced that they will report Q1, 2026 results on May 07, 2026 Ankündigung • Apr 24
INmune Bio Inc., Annual General Meeting, Jun 16, 2026 INmune Bio Inc., Annual General Meeting, Jun 16, 2026. Ankündigung • Apr 16
Inmune Bio Inc. Announces New Preclinical Data At Aacr 2026 Demonstrating Inb03 (Xpro1595) Overcomes Resistance and Reduces Metastases in Her2-Positive Breast Cancer Models INmune Bio Inc. announces new preclinical data for INB03 (XPro1595 for oncology). The data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego on April 17-22. The poster, titled, “Soluble TNF blockade overcomes tyrosine kinase inhibitors resistance in HER2-positive breast cancer,” details how INB03 (“XPro™”), a first-in-class dominant-negative soluble TNF (sTNF) inhibitor, significantly enhances the anti-tumor activity of the tyrosine kinase inhibitors (TKIs) lapatinib and tucatinib while reducing metastatic spread to the brain, lungs, and liver in HER2-positive breast cancer models. It was authored by collaborators from the Instituto de Biología y Medicina Experimental (IBYME-CONICET) in Buenos Aires, Argentina. Overcoming Resistance in Vitro: The combination of INB03 (10 µg/mL) with either lapatinib (1 µM) or tucatinib (10 µM) produced statistically superior inhibition of cell proliferation and migration in both HER2+ JIMT-1 and brain-metastatic JIMT-1 Br3-luc cell lines compared to TKIs alone (p < 0.05 to p < 0.0001). Enhanced Tumor Control In Vivo: In female nude mice bearing JIMT-1 or JIMT-1 Br3-luc tumors, INB03 + TKI combinations markedly slowed tumor growth compared to TKIs alone. Reduction of Metastatic Spread: The addition of INB03 significantly reduced the incidence of metastases to brain, lung, and liver (quantified by ex-vivo IVIS luminescence imaging). Notably, it further enhanced tucatinib’s effect on lung metastases (p < 0.05 to p < 0.0001). Mechanism of Action: These results support prior research showing that selective sTNF neutralization with INB03 down-regulates MUC4, a protein that shields the HER2 molecule and prevents therapies from binding effectively. XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of INmune Bio’s website. New Risk • Mar 31
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$24m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$24m free cash flow). Revenue is less than US$1m (US$50k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$11m net loss in 3 years). Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (US$30.3m market cap). Ankündigung • Mar 24
INmune Bio Inc. to Report Fiscal Year 2025 Results on Mar 30, 2026 INmune Bio Inc. announced that they will report fiscal year 2025 results on Mar 30, 2026 Major Estimate Revision • Mar 22
Consensus revenue estimates increase by 25% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$50.0k to US$60.0k. EPS estimate unchanged from -US$1.75 at last update. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$7.00 unchanged from last update. Share price fell 11% to US$1.17 over the past week. Ankündigung • Mar 19
INmune Bio Inc. Features Mindful Trial of Xpro Pegipanermin At AD/PD 2026 Plenary INmune Bio Inc. announced that Malú Gámez Tansey, Ph.D., Professor of Neurology at the Stark Neuroscience Research Institute at Indiana University School of Medicine, featured the Company’s Phase 2 MINDFuL trial of XPro (pegipanermin) as a centerpiece of her plenary presentation at AD/PD 2026 — the world’s international conference on Alzheimer’s and Parkinson’s diseases — taking place March 17–21, 2026 in Copenhagen, Denmark. The plenary talk, titled “The Role of Peripheral Inflammation in Neurodegenerative Disease: Who Let the Dogs Out?” explored how peripheral immune dysfunction, driven by aging and chronic inflammatory disease, creates the conditions for age-related neurodegeneration. Because inflammatory signals travel bidirectionally between the periphery and the brain, peripheral immune dysfunction can be detected directly from the blood, offering a timely and practical opportunity for intervention before neurodegeneration takes hold. Within that framework, the biomarker enrichment strategy in MINDFuL was highlighted as a successful example of how aligning patient selection with mechanism of action identifies the patients most likely to respond. The foundation of INmune Bio’s strategy is identifying Alzheimer’s patients who carry measurable evidence of peripheral inflammation, the patients for whom soluble TNF inhibition is most mechanistically relevant. The MINDFuL trial enrolled patients enriched for inflammatory biomarkers, and the results reflected that precision: nearly all efficacy endpoints in the inflamed patient subgroup favored XPro1595, a broad and consistent signal that the right patients were identified and the drug performed as the science predicted. Following positive alignment with the FDA at a recent End-of-Phase 2 meeting, INmune Bio is advancing an integrated Phase 2b/3 registrational program for XPro1595 in early Alzheimer’s patients enriched for inflammatory biomarkers, building directly on the MINDFuL foundation with a larger, longer-duration study designed for registration. XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. Major Estimate Revision • Mar 12
Consensus revenue estimates decrease by 20% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$60.0k to US$50.0k. EPS estimate unchanged from -US$1.75 per share at last update. Biotechs industry in the US expected to see average net income decline 8.5% next year. Consensus price target up from US$5.25 to US$7.00. Share price rose 5.1% to US$1.33 over the past week. Price Target Changed • Mar 11
Price target increased by 42% to US$7.00 Up from US$4.92, the current price target is an average from 4 analysts. New target price is 393% above last closing price of US$1.42. Stock is down 84% over the past year. The company is forecast to post a net loss per share of US$1.75 next year compared to a net loss per share of US$2.11 last year. Major Estimate Revision • Feb 13
Consensus revenue estimates increase by 25% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$50.0k to US$60.0k. EPS estimate unchanged from -US$1.75 at last update. Biotechs industry in the US expected to see average net income decline 6.6% next year. Consensus price target of US$5.25 unchanged from last update. Share price fell 4.6% to US$1.44 over the past week. New Risk • Feb 13
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$50k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$17m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (US$41.7m market cap). Ankündigung • Feb 12
INmune Bio Announces FDA Alignment on Integrated Phase 2b/3 Registration Pathway for XPro1595 in Early Alzheimer's Disease INmune Bio Inc. announced that it received the official minutes from its End-of-Phase 2 (Type B) meeting with the U.S. Food and Drug Administration (FDA). The minutes confirm regulatory alignment on the Company's proposed integrated Phase 2b/3 clinical development strategy for XPro1595 in early Alzheimer's Disease (AD). The FDA's feedback was consistent with the Company's precision medicine approach, which utilizes an enrichment-led trial design to identify patients whose inflammatory biomarker profiles are mechanistically linked to soluble TNF signaling, the biological target of XPro1595. The Agency's review was informed by the Company's Phase 2 clinical data package, including cognitive and biomarker analyses in the enriched population. Key Highlights of FDA Alignment: Integrated Phase 2b/3 Framework: The FDA indicated no objection to the Company's proposed integrated Phase2b/3 design under a single master protocol. Exploratory Cohort: At the FDA's recommendation, the trial will include an exploratory cohort (approximately 20% of enrollment) of non-enriched early Alzheimer's Disease patients to assess the broader effect of XPro1595. the Phase 2b portion of the study includes a nine-month evaluation period designed to establish the clinical evidence base for Phase 3. The Phase 2b assessment will be informed by the Early Mild Alzheimer's Cognitive Composite (EMACC), a cognitive measure, and plasma p-tau-217, a marker of neurodegeneration. INmune Bio is incorporating the FDA's feedback into the final Phase 2b/3 protocol and anticipates submitting the protocol to the Agency for review. Ankündigung • Feb 10
INmune Bio Advances CORDStrom Towards UK Marketing Authorization in RDEB INmune Bio Inc. announced a critical step toward the commercialization of CORDStrom for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The Company has formally submitted its pre-submission package for CORDStrom with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA). Current options are limited to topical wound treatments. INmune Bio has completed three commercial pilot-scale manufacturing runs at the CGT Catapult facility, each demonstrating consistent product characteristics that met predefined release criteria. These manufacturing results confirm readiness for commercial supply. CORDStrom has already been granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation for the treatment of EB in the United States. These designations take on added significance following the February 3, 2026, passed legislation that reauthorizes the FDA's Rare Pediatric Disease Priority Review Voucher (PRV) program through September 30, 2029 (incorporated into the Consolidated Appropriations Act, 2026, via the Mikaela Naylon Give Kids a Chance Act). The program incentivizes development of therapies for rare pediatric diseases like RDEB by awarding a transferable priority review voucher upon approval. RDEB not only manifests as extreme fragility of the skin but also inflammation of internal linings of the mouth, gut and behind the eyes, leading to widespread pain, failure to thrive and multi-organ complications and even increasing the risk of skin cancer. RDEB affects nearly every organ system. Limited options are available for treatment, none of which address the systemic tissue damage. Price Target Changed • Feb 02
Price target increased by 29% to US$6.33 Up from US$4.92, the current price target is an average from 3 analysts. New target price is 301% above last closing price of US$1.58. Stock is down 84% over the past year. The company is forecast to post a net loss per share of US$1.68 next year compared to a net loss per share of US$2.11 last year. Ankündigung • Dec 20
INmune Bio, Inc. has filed a Follow-on Equity Offering in the amount of $65 million. INmune Bio, Inc. has filed a Follow-on Equity Offering in the amount of $65 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Ankündigung • Dec 11
INmune Bio, Inc. has completed a Follow-on Equity Offering in the amount of $75 million. INmune Bio, Inc. has completed a Follow-on Equity Offering in the amount of $75 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 48,762
Price\Range: $6.96
Discount Per Security: $0.2088
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,304,707
Price\Range: $8.01
Discount Per Security: $0.2403
Transaction Features: At the Market Offering Ankündigung • Dec 05
Peer Reviewed Study Highlights Therapeutic Potential Around Application of Stromal Cell Therapies Such as Inmune Bio's CORDStrom™? Platform INmune Bio, Inc. announced a recently published overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies, such as INmune's CORDStrom™? platform. The article, titled, "Fate and Function of Exogenously Administered MSCs: Current Insights and Future Directions," was published in the peer-reviewed journal Cytotherapy. One of the lead authors of the paper was INmune Bio's lead scientist for CORDStrom™? R&D, Dr Nikita M. Patel, M.Sci.,Ph.D. The article, was the result of an invitation-only working party of basic, clinical and translational scientists working on MSCs and available on Cytotherapy's website, reviews the current knowledge-base and critical gaps in order to formulate experimental questions designed to enhance development of MSC therapies such as the CORDStrom™? platforms. CORDStrom™? products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced affordably and with repeatable specification, independent of donor characteristics. While the first generation CORDStrom™? product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be optimized for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics. Ankündigung • Dec 02
INmune Bio, Inc. Reports New Phase 2 Grey Matter Imaging Data at CTAD Conference Reinforcing XPro1595’s Evidence Base in High-Inflammation Alzheimer's Patients INmune Bio, Inc. announced new neuroimaging data from its Phase 2 MINDFuL trial of XPro1595 in patients with early Alzheimer's disease (AD) and elevated neuroinflammation. The results will be presented at the 18th Clinical Trials on Alzheimer's Disease conference (CTAD), being held on December 1-4, 2025 in San Diego, CA. The new analyses add to the growing body of clinical, biomarker, and imaging evidence supporting XPro1595's mechanism of selectively neutralizing soluble TNF (sTNF). The data further validate the Company's strategy of targeting inflammation-driven AD, a large, underserved subset representing a significant unmet need and potential commercial opportunity. Using PerpPD+, a next-generation MRI imaging analysis that quantifies the diffusion components of water molecules that are perpendicular to the cortical gray matter's minicolumns in the brain (PerpDP+, from Oxford Brain Diagnostics), investigators observed a trend towards slowed neurodegeneration progression in patients receiving XPro1595. These analyses focused on participants with early AD and high inflammatory burden (ADi), including the dose-compliant subgroup. The PerpPD+ findings suggest attenuated increases in cortical disarray, an imaging hallmark associated with neurodegeneration. These results reinforce previously reported directional improvements across biological, cognitive, and neuropsychiatric endpoints and align with XPro1595’s mechanism of reducing innate immune dysfunction. The poster presentation of XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial outlines the first neuroimaging results of the Company’s Phase 2 randomized, double-blind, placebo-controlled study in patients with early Alzheimer’s disease (AD) and elevated inflammatory biomarkers receiving either XPro1595 or placebo. Results in the change from baseline at 24 weeks in PerpPD+, a grey matter imaging analysis developed by Oxford Brain Diagnostics, were analyzed in participants with early AD and a high inflammatory burden (ADi) and in dose-compliant ADi. The data show XPro1595 slowed disease progression as observed by a trend in an attenuated increase in PerpPD+, which indicated microscopic disruption of disarray in cortical structure. This reduction may indicate a slowing of neurodegeneration in the target population. In addition, these neuroimaging results are supportive of the previously reported directional effects on biological, cognitive and neuropsychiatric endpoints. INmune Bio confirmed that additional MRI analyses from the MINDFuL trial are ongoing and will be presented when available. These forthcoming data are expected to provide a broader picture of XPro1595’s tissue-level impact on both gray- and white-matter integrity in ADi. The Company believes totality of data generated to date, including the neuroimaging findings, position XPro1595 as a promising first-in-class disease-modifying therapy for the large subset of Alzheimer’s patients with elevated neuroinflammation. This population has limited treatment options, and no currently approved therapy is designed to target innate immune dysfunction. Ankündigung • Oct 23
INmune Bio, Inc. to Report Q3, 2025 Results on Oct 30, 2025 INmune Bio, Inc. announced that they will report Q3, 2025 results on Oct 30, 2025 Ankündigung • Sep 30
INmune Bio, Inc. Announces Submission of Phase 2 MINDFuL Trial Results in Alzheimer's Disease to Nopj Dementia, a Nature Portfolio Journal INmune Bio, Inc. announced the submission of a manuscript detailing the results of its Phase 2 MINDFuL trial. The manuscript, titled, "XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer's Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial," has been submitted for peer review to npj Dementia, a Nature Portfolio journal. Key findings within the biomarker-enriched ADi population include: XPro™? demonstrated consistent positive trends across cognitive, neuropsychiatric, and biological endpoints, which suggests that targeting neuroinflammation by selectively neutralizing soluble TNF may offer benefits for a specific subset of individuals living with Alzheimer's disease, supporting continued development of XPro™? as a precision medicine approach for this patient group. Complete absence of amyloid-related imaging abnormalities (ARIA), a serious side effect commonly associated with amyloid-targeting therapies. This favorable safety profile was observed in a high-risk patient population, including significant numbers of APOE4 carriers, patients receiving anticoagulant medications, and individuals with multiple cerebral microbleeds. This distinguishes XPro™? from other treatments and suggests its potential for broader use, including in combination therapies. XPro™? (also referred to as "XPro1595") is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF or TNF receptors. XPro™? could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio's website. Ankündigung • Sep 15
INmune Bio, Inc. Announces Successful Completion of First Commercial Pilot-Scale Manufacturing Run of CORDStrom™? At CGT Catapult INmune Bio Inc. announced the successful completion of its first full-scale pilot commercial manufacturing run of CORDStrom™?, an off-the-shelf, allogeneic, umbilical cord tissue-derived mesenchymal stromal cell therapy for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB). This milestone, achieved at the Cell and Gene Therapy Catapult's Manufacturing Innovation Centre in Stevenage, United Kingdom, marks a critical step toward regulatory submissions and keeps the Company on track for filing a Marketing Authorization Application (MAA) in the UK during the first half of 2026 followed by a Biologics License Application (BLA) in the US. CORDStrom™? is designed to address the severe unmet systemic needs of RDEB patients. INmune Bio has three product platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical development to determine if they can treat Alzheimer's disease and other indications (XPro™?). The Natural Killer Cell Priming Platform includes INKmune®? developed to prime a patient's NK cells to eliminate minimal residual disease in patients with cancer and is currently in trials in metastatic castration-resistance prostate cancer. The third program, CORDStrom™?. The third program, CordStrom™?, is a proprietary allogeneic, pooled, human umbilical cord-derived mesenchymal Stromal cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa. Ankündigung • Aug 05
INmune Bio's CaRe PC Trial of INKmune™ in Metastatic Castration-Resistant Prostate Cancer Meets Endpoints and Is Closed to Enrollment INmune Bio Inc. reported that its Phase I/II trial (the "CaRe PC" trial) of INKmune™ for men with metastatic castration-resistant prostate cancer (mCRPC) has met its primary and secondary endpoints and is now closed to further enrollment. INKmune™ was well tolerated at all three dose levels in the trial, demonstrating an excellent safety profile, the primary endpoint of CaRe PC. Following the successful completion of the Phase 1/2 trial of INKmune®? in patients with advanced-stage disease, INmune Bio plans to advance the program by designing a randomized Phase 2b trial in patients with less severe disease, enabling a more robust measurement of the drug's effects and potential clinical benefits. INmune™ is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient's resting NK cells into tumor killing memory-like NK cells (mlNK cells). INKmune™ is treating patients in an open label Phase I/II trial in metastatic castration- resistant prostate cancer in the US this year. Ankündigung • Aug 01
INmune Bio, Inc. to Report Q2, 2025 Results on Aug 07, 2025 INmune Bio, Inc. announced that they will report Q2, 2025 results on Aug 07, 2025 Ankündigung • Jul 24
INmune Bio Inc. to Present Phase 2 MINDFuL Trial Findings of XPro at the Alzheimer's Association International Conference INmune Bio Inc. announced that additional analyses from its Phase 2 MINDFuL trial evaluating XPro™?, a novel selective soluble TNF inhibitor, will be released in an oral presentation at the Alzheimer's Association International Conference (AAIC) in Toronto, Canada. The MINDFuL trial is a double-blind, Phase 2 proof-of-concept study examining the potential of XPro™ to slow cognitive decline in early-stage Alzheimer’s disease (AD) by targeting neuroinflammation. The trial enrolled 208 participants with early AD who had one or more biomarkers of inflammation — elevated C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), hemoglobin A1c (HbA1c), or an ApoE4 allele. Participants received XPro™ or placebo in a 2:1 ratio, respectively, for 24 weeks, with changes in cognition measured via the Early Mild Alzheimer’s Cognitive Composite (EMACC). While the primary endpoint was not met in the overall modified-intent-to-treat mITT group, key changes in clinical measures of cognition, behavior, and AD-related biomarkers demonstrated a consistent benefit of treatment with XProTM after 6 months in a subpopulation of patients with biomarker confirmed amyloid-beta (Aß) pathology and =2 of the blood biomarkers of systemic inflammation. INmune Bio anticipates submitting a publication by mid-August of the MINDFuL Phase 2 study results. Additionally, the company is seeking a strategic partnership to accelerate the further development of XPro™ as a treatment for Alzheimer’s disease. New Risk • Jul 02
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 34% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (21% average weekly change). Shareholders have been substantially diluted in the past year (34% increase in shares outstanding). Revenue is less than US$1m (US$50k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$31m net loss in 3 years). Market cap is less than US$100m (US$55.6m market cap). New Risk • Jul 01
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$53.6m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (21% average weekly change). Revenue is less than US$1m (US$50k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$34m net loss in 3 years). Shareholders have been diluted in the past year (17% increase in shares outstanding). Market cap is less than US$100m (US$53.6m market cap). Ankündigung • Jul 01
INmune Bio, Inc. Reports Key Findings from Phase 2 MINDFuL Trial of XPro in Early Alzheimer's Disease INmune Bio Inc. announced results from its Phase 2 MINDFuL trial (NCT05318976) evaluating XPro™, a selective soluble TNF inhibitor, in early AD with biomarkers of inflammation. Despite showing no effects in the modified intent-to-treat population (mITT, n=200), predefined analyses demonstrated a cognitive benefit for XPro™ over placebo on the primary endpoint EMACC, a behavioral benefit on the Neuropsychiatric Inventory, and a biological benefit on pTau217 in early Alzheimer’s patients with two or more biomarkers of inflammation at baseline (n=100), marking a key milestone in the development of XPro™ for Early AD. The MINDFuL trial, a double-blind, placebo-controlled study, enrolled 208 participants with early-stage AD to assess XPro™’s potential in slowing cognitive decline by tackling neuroinflammation. Patients with at least one of four inflammatory biomarkers (elevated CRP, ESR, HbA1c, or at least one ApoE4 allele) were randomized 2:1 (XPro™:placebo) and treated over 24 weeks. The primary endpoint was change in cognition over 6 months on the Early Mild Alzheimer’s Cognitive Composite (EMACC), a cognitive assessment designed specifically to measure change in early AD patients. While the primary endpoint was not met in the mITT group, key changes in clinical measures of cognition, behavior, and an AD-related biomarker demonstrated a benefit in a subpopulation of patients treated with XPro™ over patients treated with placebo. These results identify a clear population of AD patients for which XPro™ might have therapeutic benefit. Key Findings in the Amyloid positive Early AD participants with two or more biomarkers of inflammation (N=100):Cognition: A clinical benefit of XPro™ over placebo was observed on the primary endpoint EMACC (effect size: 0.27) and on the secondary endpoint Neuropsychiatric Inventory (effect size: -0.24). Alzheimer’s Disease Biomarkers: A biological benefit of XPro™ over placebo was observed in blood levels of pTau217 (effect size: -0.20), the gold standard measure of AD pathology in blood. Safety and tolerability: XPro™ treatment was safe and well tolerated, without any occurrences of ARIA-E or ARIA-H. Injection site reactions (ISR) were common (80% of XPro™ group compared to placebo group (<20%). ISRs were short-term redness and/or pain at the injection site in two thirds of cases. Of the 14 patients in the XPro™ arm that discontinued the trial, ISR was the cause in 10 patients. There were no deaths, drug-related hospitalizations or organ system toxicity in the trial. Novel mechanism of action: This study demonstrates that it is possible to safely target neuroinflammation in patients where neuroinflammation is a driver of AD pathology. With the increased interest in inflammation as a disease-modifier in AD and neurodegeneration, these results provide the basis for further development of XPro™ in neurodegeneration. Next Steps: INmune Bio will present additional analyses from the MINDFuL trial at AAIC® in Toronto, Canada (July 27-31, 2025). Based on the totality of the data, the company intends to: File for Breakthrough Therapy Designation with the FDA.Schedule an End-of-Phase 2 meeting with the FDA in Fourth Quarter 2025 to define the path for a pivotal trial to support XPro™ approval in early AD.Engage regulatory authorities in the UK, EU, and other regions in parallel. Ankündigung • Jun 30
INmune Bio, Inc. has completed a Follow-on Equity Offering in the amount of $18.9 million. INmune Bio, Inc. has completed a Follow-on Equity Offering in the amount of $18.9 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,000,000
Price\Range: $6.3
Discount Per Security: $0.441
Transaction Features: Registered Direct Offering Ankündigung • Jun 11
INmune Bio, Inc. Announces That XPro™ Reduced Amyloid and Enhances Behavior Post Traumatic Brain Injury in an Animal Model of Alzheimer’s Disease: Supported by Department of Defense INmune Bio, Inc. is collaborating with Kirsty Dixon PhD, Assoc Prof. of Surgery at Virginia Commonwealth University in Richmond, Virginia on the interaction of TBI and AD. Prof Dixon and her team presented a poster at the Keystone Symposia’s Neurodegeneration section: Linking Cellular Pathways to Therapeutic Strategies in Whistler, British Columbia, Canada. The poster demonstrates that Traumatic Brain Injury (TBI) increases amyloid deposition in high-risk animals and that administration of XPro™ (XPro1595, pegipanermin) significantly reduces amyloid formation and improves clinical measures of brain function. Traumatic Brain Injury is a well-established risk factor for Alzheimer’s disease (AD). TBI promotes neuroinflammation, increasing the inflammatory cytokine Tumor Necrosis Factor (solTNF), which has been implicated in AD progression. A key protein in AD pathogenesis is the enzyme ß-secretase (BACE1), which cleaves amyloid precursor protein (APP) to generate neurotoxic amyloid beta (Aß42), potentially leading to neuronal loss. Under pathological conditions, TNF receptor 1 (TNFR1) upregulates BACE1 and cell death pathways. Therefore, targeting TBI-induced solTNF/TNFR1 signaling may mitigate Aß42 production and neuronal loss, providing a critical translational link between TBI and AD. The study showed that TBI triggered a transient increase in TNFR1, BACE1, and Aß42 expression in the hippocampus, peaking three days post-injury and returning to baseline by day seven. Administering XPro™ thirty minutes post-injury inhibited solTNF/TNFR1 activity and prevented elevations in TNFR1, BACE1, Aß42, and caspase-3 levels. Immunofluorescence revealed that XPro™ treatment reduced intracellular neuronal amyloid accumulation in the hippocampus and improved neurological outcomes in treated animals. Poster Number: 2537 Session: Poster Session 2: 6/10/2025 Neurodegeneration: Linking Cellular Pathways to Therapeutic Strategies; Poster Title: TBI-induced solTNF/TNFR1 exacerbates Alzheimer’s disease pathophysiology and neurological deficits. Authors: Chelsie N. Poffenberger, Subrat Poudel, Michelle M. Taylor, Elliott J. Mufson, Kirsty J. Dixon. Reported Earnings • May 09
First quarter 2025 earnings released: US$0.43 loss per share (vs US$0.61 loss in 1Q 2024) First quarter 2025 results: US$0.43 loss per share (improved from US$0.61 loss in 1Q 2024). Net loss: US$9.74m (loss narrowed 12% from 1Q 2024). Revenue is forecast to grow 63% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has only fallen by 1% per year, which means it has not declined as severely as earnings. Ankündigung • May 05
INmune Bio, Inc. to Report Q1, 2025 Results on May 08, 2025 INmune Bio, Inc. announced that they will report Q1, 2025 results on May 08, 2025 Ankündigung • Apr 23
INmune Bio, Inc., Annual General Meeting, May 28, 2025 INmune Bio, Inc., Annual General Meeting, May 28, 2025. Ankündigung • Mar 29
INmune Bio, Inc. Auditor Raises 'Going Concern' Doubt INmune Bio, Inc. filed its 10-K on Mar 27, 2025 for the period ending Dec 31, 2024. In this report its auditor, Marcum LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern. Reported Earnings • Mar 28
Full year 2024 earnings: EPS and revenues exceed analyst expectations Full year 2024 results: US$2.11 loss per share (further deteriorated from US$1.67 loss in FY 2023). Net loss: US$42.1m (loss widened 40% from FY 2023). Revenue exceeded analyst estimates by 150%. Earnings per share (EPS) also surpassed analyst estimates by 6.1%. Revenue is forecast to grow 64% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 5% per year whereas the company’s share price has fallen by 4% per year. Ankündigung • Mar 24
INmune Bio, Inc. to Report Q4, 2024 Results on Mar 27, 2025 INmune Bio, Inc. announced that they will report Q4, 2024 results on Mar 27, 2025 Major Estimate Revision • Feb 14
Consensus revenue estimates decrease by 25% The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$10.0k to US$10.0k. EPS estimate unchanged from -US$2.30 per share at last update. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target up from US$19.83 to US$22.17. Share price fell 4.3% to US$9.18 over the past week. Breakeven Date Change • Feb 12
Forecast to breakeven in 2027 The 5 analysts covering INmune Bio expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$2.35m in 2027. Average annual earnings growth of 50% is required to achieve expected profit on schedule. Ankündigung • Feb 12
INmune Bio Opens Phase II in High Dose Cohort of INKmune Trial in Prostate Cancer INmune Bio Inc. continues to advance its Natural Killer (NK) cell therapy, INKmune™, in a Phase I/II trial (the "CaRe PC" trial) for men with metastatic castration-resistant prostate cancer (mCRPC). The Company announced completion of the third and highest dose cohort of the Phase II portion of the trial allowing opening of the Phase II high dose cohort. The Scientific Review Committee (SRC) charter is to review the safety data from the patients treated in the Phase I portion of the trial as required by the FDA. On February 12, 2025, the SRC held the third meeting evaluating the safety in INKmune™ therapy in men with mCRPC. The SRC unanimously voted to open all Phase II cohorts of the CaRePC trial to enrollment. INKmune™ is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient’s resting NK cells into tumor killing memory-like NK cells (mlNK cells). INKmune™ treatment converts the patient’s own NK cells into mlNK cells. In patients, INKmune™ primed tumor killing NK cells have persisted for more than 100 days. These cells function in the hypoxic TME because due to up-regulated nutrient receptors and mitochondrial survival proteins.INKmune™ is a patient friendly drug treatment that does not require pre-medication, conditioning or additional cytokine therapy to be given to the patients. INKmune™ is easily transported, stored and delivered to the patient by a simple intravenous infusion as an out-patient. INKmune™ is tumor agnostic; it can be used to treat many types of NK-resistant tumors including leukemia, lymphoma, myeloma, lung, ovarian, breast, renal and nasopharyngeal cancer. INKmune™ is treating patients in an open label Phase I/II trial in metastatic castration-resistant prostate cancer in the US. Ankündigung • Feb 10
INmune Bio, Inc. Announces Plan to Submit FDA Biologics License Application Seeking Approval of Cordstrom for Treatment of Recessive Dystrophic Epidermolysis Bullosa INmune Bio, Inc. announced, following a Type C meeting with the U.S. Food and Drug Administration, its intent to submit a BLA in the US and Marketing Authorization Application (MAA) in the UK and EU supported by data from the MissionEB clinical trial investigating CORDStrom as a disease-modifying therapy for treating RDEB in pediatric patients. Benefits of an ODD include certain tax credits and eligibility for select grants, waiver of FDA user fees, including the BLA application fees, access to frequent meetings with the FDA for efficient drug development, and eligibility for seven (7) years of market exclusivity post approval. In addition to these developments involving CORDStrom, the Company reiterates plans to report top-line data on cognitive function in its MINDFuL study, a Phase II trial investigating XproTM for treatment of Alzheimer's disease with inflammation, in June of this year, and further plans to announce additional data in its CaRe PC study, an open-label, phase I/IIa dose escalation and expansion study of INKmune in men with metastatic castration-resistant prostate cancer (mCRPC) as it becomes available throughout 2025. The company will host a webinar at 8:30 AM ET to discuss the results of the MissionEB study investigating CORDStrom for treatment of RDEB in pediatric patient. The third program, CORDStrom, is a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa. CORDStrom, XPro1595 (XPro), andINKmune™? are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (F FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to produce more drug for clinical trials; the availability of a single-blinded, randomized, placebo-controlled study, which is currently in trials in metastatic castration-resistance prostate cancer. Ankündigung • Jan 30
INmune Bio Inc. Expands INKmune Trial in Prostate Cancer to Veterans INmune Bio, Inc. has an ongoing Phase I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC). The Company announced the participation of a patient at the West Los Angeles VA Medical Center in the trial. The participant received the investigational intervention, as an out-patient per the protocol, under the care of Matthew Rettig, MD., Chief, Hematology-Oncology, VA Greater Los Angeles Healthcare System, Professor of Medicine and Urology, Medical Director Prostate Cancer Program, David Geffen School of Medicine and the Jonsson Comprehensive Cancer Center at the UCLA. The VA Health Care System provides medical care to the Veterans of the US military. Every year, approximately 15,000 Veterans are diagnosed and treated at the VA for prostate cancer and over 200,000 Veterans are prostate cancer survivors. Under Rettig’s leadership, 900 patients with prostate cancer have participated in over two dozen clinical trials at the West LA VA Medical Center. The Care PC trial is the first using a NK targeted biologic therapy. The Veteran received the “medium” dose of INKmune initiating the Phase II portion of the trial. In 2022, Congress signed into law the Joseph Maxwell Cleland and Robert Joseph Dole Memorial Veterans Benefits and Health Care Improvement Act of 2022, also known as the Cleland-Dole Act. In response to the Cleland-Dole Act, which requires VA to make strides in prostate cancer care, the VA has published a prostate cancer clinical pathway, which expressly considers incorporation of clinical trials, and patient educational materials, and is in the process of creating a national prostate cancer registry. New Risk • Jan 14
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$26m free cash flow). Revenue is less than US$1m (US$42k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$30m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (23% increase in shares outstanding). New Risk • Dec 20
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$98.0m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$26m free cash flow). Revenue is less than US$1m (US$42k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$30m net loss in 3 years). Shareholders have been diluted in the past year (23% increase in shares outstanding). Market cap is less than US$100m (US$98.0m market cap). Ankündigung • Nov 13
INmune Bio Inc. Announces Final Enrollment of 208 Patients in Phase 2 Trial in Early Alzheimer's Disease INmune Bio, Inc. announced that it completed randomization of patients for its Phase 2 trial on November 11th. This global, blinded, randomized Phase 2 trial (the "AD02 trial") is focused on patients with Early AD and biomarkers of elevated neuroinflammation. AD02 is a global, blinded, randomized Phase II trial in patients with Early AD using XPro™. The trial uses enrichment criteria to focus the trial on patients with neuroinflammation as a cause of their cognitive decline. XPro™ targets glial cells that drive neuroinflammation in the brain to allow decreased neurodegeneration and demyelination with improved synaptic function and remyelination. The primary end-point of AD02 is change from baseline cognitive function after 24 weeks of therapy, measured using EMACC and CDR-SB. New Risk • Nov 07
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 16% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$26m free cash flow). Earnings are forecast to decline by an average of 16% per year for the foreseeable future. Revenue is less than US$1m (US$42k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$68m net loss in 3 years). Share price has been volatile over the past 3 months (9.8% average weekly change). Shareholders have been diluted in the past year (23% increase in shares outstanding). Reported Earnings • Nov 01
Third quarter 2024 earnings released: US$0.60 loss per share (vs US$0.48 loss in 3Q 2023) Third quarter 2024 results: US$0.60 loss per share (further deteriorated from US$0.48 loss in 3Q 2023). Net loss: US$12.1m (loss widened 41% from 3Q 2023). Revenue is forecast to grow 86% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 4% per year but the company’s share price has fallen by 25% per year, which means it is performing significantly worse than earnings. Ankündigung • Oct 24
INmune Bio, Inc. to Report Q3, 2024 Results on Oct 31, 2024 INmune Bio, Inc. announced that they will report Q3, 2024 results on Oct 31, 2024 Recent Insider Transactions • Oct 01
CFO, Treasurer & Secretary recently bought US$53k worth of stock On the 30th of September, David Moss bought around 10k shares on-market at roughly US$5.29 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger purchase from another insider worth US$98k. David has been a buyer over the last 12 months, purchasing a net total of US$252k worth in shares. Ankündigung • Oct 01
INmune Bio Inc. Completes Enrollment for Phase 2 Trial in Early Alzheimer's Disease INmune Bio Inc. announced that it closed enrollment for its Phase 2 trial on 27 September. This global, blinded, randomized Phase 2 trial (AD02 trial) is focused on patients with Early AD and biomarkers of elevated neuroinflammation. Enrollment of new patients into the trial was concluded after the Company determined that there are sufficient patients currently in screening to meet the trial’s target of 201 patients. All patients currently in the screening process will remain eligible to participate in AD02, which will likely result in modest over-enrollment. AD02 trial is an international, blinded, randomized Phase 2 trial in patients with Early AD with biomarkers of elevated neuroinflammation. Early AD includes patients with MCI (mild cognitive impairment) and mild AD. Patients must have at least one of four biomarkers of inflammation – elevated CRP, HgbA1c, ESR or ApoE4 allele. Patients receive either XPro™ or placebo (2:1 ratio) for 6 months. The cognitive endpoints are EMACC and CDR. XPro™ is given as a once-a-week subcutaneous injection. Recent Insider Transactions • Sep 18
Co-Founder recently bought US$98k worth of stock On the 12th of September, Raymond Tesi bought around 15k shares on-market at roughly US$6.38 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Raymond has been a buyer over the last 12 months, purchasing a net total of US$248k worth in shares. Ankündigung • Sep 17
INmune Bio, Inc. Announces Results of Additional Blinded Interim Analysis of Phase 2 Alzheimer's Disease Trial Demonstrating Correlation between EMACC and CDR-SB Endpoints INmune Bio Inc. announced that results of additional analysis of blinded data from its AD02 Phase II Alzheimer's Disease (AD) trial demonstrated exceptional performance of the novel cognitive measure EMACC, as well as highly significant correlation between EMACC and the Clinical Dementia Rating-Sum of Boxes (CDR-SB), the accepted endpoint for AD trials. Key Findings: Statistical Correlation: An independent review confirmed a highly significant correlation (p<0.001) between baseline scores on EMACC and CDR-SB, the secondary endpoint in the AD02 trial. CDR-SB is the clinical rating scale most used in AD registration studies. Reliability: The correlation of EMACC when measured during the screening process and again at the first study visit before treatment was found to be 0.93. Higher precision produces results that are more robust and replicable with smaller sample sizes. Differentiation Capability: The difference in EMACC performance between patients with CDR global ratings of 0.5 (prodromal AD) and those rated 1.0 (mild dementia) was very large, with an effect size (Cohen’s d) of 0.87 (p<0.0001). This demonstrates EMACC's ability to accurately differentiate between disease stages, highlighting its sensitivity and precision. About EMACC The Early AD/MCI Alzheimer’s Cognitive Composite (EMACC) is an empirically derived cognitive measure composed of standardized and widely used neuropsychological tests. These tests, in combination, showed the greatest sensitivity to change in Early Alzheimer’s Disease (AD) patients over two years of follow-up. The performance characteristics of EMACC in early AD were first reported by Biogen at CTAD in 2021. Notably, EMACC was also found to be strongly associated with biological markers of inflammation in the Alzheimer’s Disease Neuroimaging Initiative (ADNI) AD study. Conclusion These data overwhelmingly confirm the suitability of EMACC as a primary endpoint in early AD studies. Ankündigung • Sep 14
INmune Bio, Inc. has filed a Follow-on Equity Offering. INmune Bio, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,341,260
Price\Range: $5.5
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 2,341,260
Transaction Features: Registered Direct Offering Ankündigung • Aug 10
INmune Bio, Inc. has filed a Follow-on Equity Offering in the amount of $75 million. INmune Bio, Inc. has filed a Follow-on Equity Offering in the amount of $75 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Major Estimate Revision • Aug 08
Consensus EPS estimates upgraded to US$2.26 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -US$2.60 to -US$2.26 per share. Revenue forecast unchanged from US$14.0k at last update. Biotechs industry in the US expected to see average net income decline 9.3% next year. Consensus price target of US$19.67 unchanged from last update. Share price fell 4.0% to US$7.59 over the past week. New Risk • Aug 04
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$38m Forecast net loss in 3 years: US$17m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$85k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$17m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (10% increase in shares outstanding). Reported Earnings • Aug 02
Second quarter 2024 earnings released: US$0.51 loss per share (vs US$0.36 loss in 2Q 2023) Second quarter 2024 results: US$0.51 loss per share (further deteriorated from US$0.36 loss in 2Q 2023). Net loss: US$9.75m (loss widened 50% from 2Q 2023). Revenue is forecast to grow 76% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 4% per year but the company’s share price has fallen by 20% per year, which means it is performing significantly worse than earnings. Ankündigung • Jul 29
INmune Bio Inc. Announces New Phase 1 Study Data Demonstrating Dose-Dependent Effect of XPro™? on Proteins That Regulation Synapse in Alzheimer's Patients INmune Bio Inc. announced to be presenting results of a new and advanced proteomic analysis at this year's annual Alzheimer's Association International Conference (AAIC) in Philadelphia, PA. The poster summarizes dose-related changes in the cerebrospinal fluid (CSF) proteome in patients with Alzheimer's disease (AD) treated with XProTM in the company's phase 1b study. July 29, 2024, Poster #95343, Dose-related modulation of the synaptic proteome after short-term treatment with XPro1595 for Alzheimer's disease. The new analysis revealed that a 12-week treatment with XPro™ resulted in a significant change in synaptic proteins, which are essential for communication between neurons. The formation and elimination of synapses is executed by cells of the innate immune system such as astrocytes. When these cells are in a dysregulated inflammatory/immune state, synapse formation is reduced and synapse elimination is increased, resulting in loss of communication between neurons which, in the case of AD, results in cognitive impairment. Restoring synapses requires a normally functioning innate immune system. INmune Bio is currently running a phase 2 clinical trial in mild to moderate Alzheimer’s patients. Top-line results from that trial are expected in early 2025. Ankündigung • Jul 25
INmune Bio, Inc. to Report Q2, 2024 Results on Aug 01, 2024 INmune Bio, Inc. announced that they will report Q2, 2024 results on Aug 01, 2024 Ankündigung • Jun 28
INmune Bio, Inc. Completes Blinded Interim Analysis of Phase II Alzheimer's Disease Trial INmune Bio Inc. confirmed the Phase II Alzheimer's Disease clinical trial, AD02, is appropriately powered following a blinded sample size re-estimation using the trial's primary endpoint, the Early Mild Alzheimer's Cognitive Composite (EMACC). The third-party evaluation concluded that the trial design, operational execution, data collection, and management are of the highest quality. The main goal of the blinded analysis was to evaluate the power and performance characteristics of the primary endpoint, the EMACC. The EMACC is an empirically validated cognitive measure composed of standardized and widely used neuropsychological tests that are ideally suited for use in clinical trials in Early Alzheimer's Disease (AD). Compared to CDR-SB and ADAS-Cog for example, the EMACC is an objective measure of cognitive function that accurately captures cognitive changes that occur during early AD. This interim analysis confirmed once again its excellent suitability for this population as indicated by normally distributed data, paucity of outliers and absence of floor and ceiling effects. The blinded review of EMACC's critical psychometric parameters exceed my expectations and reinforces that the EMACC is the appropriate test to measure cognition in INmune Bio's AD02 clinical trial. Ankündigung • May 31
INmune Bio, Inc., Annual General Meeting, Jul 19, 2024 INmune Bio, Inc., Annual General Meeting, Jul 19, 2024. New Risk • May 13
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 13% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Revenue is less than US$1m (US$131k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$51m net loss in 2 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (10% increase in shares outstanding). Reported Earnings • May 12
Full year 2023 earnings released: US$1.67 loss per share (vs US$1.52 loss in FY 2022) Full year 2023 results: US$1.67 loss per share (further deteriorated from US$1.52 loss in FY 2022). Net loss: US$30.0m (loss widened 9.9% from FY 2022). Revenue is forecast to grow 68% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has increased by 1% per year, which means it is well ahead of earnings. Major Estimate Revision • May 12
Consensus EPS estimates fall by 24% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -US$2.22 to -US$2.75 per share. Revenue forecast of US$37.3k unchanged since last update. Biotechs industry in the US expected to see average net income decline 9.1% next year. Consensus price target of US$19.67 unchanged from last update. Share price fell 13% to US$10.02 over the past week. Ankündigung • May 09
INmune Bio, Inc. to Report Q1, 2024 Results on May 09, 2024 INmune Bio, Inc. announced that they will report Q1, 2024 results on May 09, 2024 Ankündigung • Apr 26
INmune Bio, Inc. has filed a Follow-on Equity Offering in the amount of $9.70224 million. INmune Bio, Inc. has filed a Follow-on Equity Offering in the amount of $9.70224 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 986,000
Price\Range: $9.84
Transaction Features: Registered Direct Offering Recent Insider Transactions • Apr 25
Independent Director recently bought US$246k worth of stock On the 19th of April, Scott Juda bought around 30k shares on-market at roughly US$8.32 per share. This transaction amounted to 80% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$715k more in shares than they have sold in the last 12 months. Ankündigung • Apr 25
Inmune Bio Inc. Announces 24-Month Stability Validation of Xpro™ for Phase III Readiness and Commercial Supply Chain Modeling & Development of Novel Immunogenicity Assay INmune Bio, Inc. announced the successful completion of the extended stability validation for XProTM continuous storage in solution at 2-8C. The 24 and 30-month stability test samples passed all chemistry and potency assays; allowing the Company to make a conservative claim of 24-month stability. The 24-month stability claim is consistent with other pegylated cytokines, such as alpha-interferon, and allows the Company to design a global supply chain using proven and established systems. With this data, the company can benefit from such existing systems that use temperature controlled and monitored shipment of liquid-formulation drugs at 2-8C, which is routine across the pharmaceutical industry. The 24-month stability data confirms that XProTM can mirror these established supply chain strategies. In addition to the 24-month stability progress, the Company further announced that it has filed a patent application after it successfully developed an anti-drug antibody assay for XProTM that mitigates false positive readings associated with the application of conventional bridging and affinity capture elution (ACE) formats. Due to XProTM’s unique mechanism, namely trimerization and exchange of monomeric units, the application of such conventional assays can be problematic. The detection of anti-drug antibodies for XProTM in human serum according to the new assay utilizes a novel ACE-AG format. Details of the assay will be disclosed in the forthcoming 18th Workshops on Recent Issues in Bioanalysis (WRIB) in San Antonio, TX this coming May 7, 2024, with a poster titled “Anti-Drug Antibody (ADA) Assay for XPro 1595, a Self-Assembling Trimer: Alternative to Standard Bridging or ACE Approaches”. “This new assay is the product of a unique challenge and applied innovation, which has now resulted in the filing of a patent application adding value to the XPro1595 franchise” said Joshua Schoonover, the Company’s General Counsel. Tho Company remains on track in line with prior guidance to complete its Phase 2 clinical trial involving the use of XProTM for the treatment of Alzheimer’s Disease in patients with biomarkers of neuroinflammation. Ankündigung • Apr 23
INmune Bio, Inc. has filed a Follow-on Equity Offering. INmune Bio, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 571,592
Price\Range: $8.32
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 571,592
Transaction Features: Registered Direct Offering Major Estimate Revision • Apr 04
Consensus revenue estimates decrease by 35%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$60.0k to US$40.0k. EPS estimate increased from -US$2.33 to -US$2.19 per share. Biotechs industry in the US expected to see average net income decline 9.6% next year. Consensus price target of US$19.67 unchanged from last update. Share price fell 13% to US$10.10 over the past week. New Risk • Apr 01
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 5.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 5.7% per year for the foreseeable future. Revenue is less than US$1m (US$155k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$40m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Reported Earnings • Mar 31
Full year 2023 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2023 results: US$1.67 loss per share (further deteriorated from US$1.52 loss in FY 2022). Net loss: US$30.0m (loss widened 9.9% from FY 2022). Revenue exceeded analyst estimates by 9.7%. Earnings per share (EPS) missed analyst estimates by 1.2%. Revenue is forecast to grow 68% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has only fallen by 2% per year, which means it has not declined as severely as earnings. Ankündigung • Mar 27
INmune Bio, Inc. to Report Q4, 2023 Results on Mar 28, 2024 INmune Bio, Inc. announced that they will report Q4, 2023 results on Mar 28, 2024 Ankündigung • Mar 08
INmune Bio, Inc. Reports Significant EEG Improvement in Alzheimer's Patients Treated with XPro INmune Bio, Inc. reported significant improvements in electroencephalography (EEG), a biomarker of brain function, in patients with moderate to severe Alzheimer’s Disease treated with XPro for four weeks. Patients who received weekly XPro™ treatment for four weeks had a statistically significant increase in Alpha wave frequency and power (p<0.05). Reduced Alpha power is linked with cognitive decline and the progression of Alzheimer’s Disease. Alpha waves represent synchronized brain network activity that are essential for internal functions like mental arithmetic, short-term and working memory, and visual-spatial mental imagery exercises. In individuals with AD, Alpha wave power is diminished due to the breakdown of brain networks associated with degeneration. The seven patient pilot study in patients with moderate to severe AD sought to evaluate the utility of EEG as a functional biomarker of target engagement in evaluating the effects of XPro™ (XPro1595; pegipanermin), a next generation dominant-negative inhibitor of soluble TNF, in AD patients. These positive results support and add to the findings of the Phase 1 study in patients with AD that showed XPro™ treatment reduced biomarkers of inflammation and improved biomarkers of neurodegeneration, synaptic function and improved brain microstructure and promoted remyelination. The extent to which these biomarker changes impact cognition in patients with Early Alzheimer's Disease is currently being assessed in ongoing randomized, placebo-controlled Phase 2 trial. EEG, long considered a gold standard in objectively measuring brain activity, provides valuable insight into neural connectivity. Neurological research has consistently highlighted a progressive decline in alpha band power and frequency in individuals with MCI and Alzheimer's disease. EEG's capability to assess brain function makes these findings particularly noteworthy for INmune Bio’s novel treatment strategy. The use of EEG as a biomarker for brain function and its potential as a regular measure in clinical trials was facilitated by Cumulus Neuroscience’s innovative, FDA approved, portable EEG device. Ankündigung • Jan 31
Inmune Bio Announces FDA Removal of Clinical Hold for Alzheimer’S Disease Program INmune Bio Inc. announced dominant-negative inhibitor of soluble TNF, received correspondence from the FDA confirming that the full clinical hold on the Company’s AD clinical trial program has been lifted. The Phase II trial is on track to enroll the last patient mid-2024. Top line data is expected approximately six months after the last patient is enrolled. New Risk • Jan 30
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$224k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$44m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Ankündigung • Dec 19
INmune Bio, Inc. Provides Update Regarding Global Alzheimer's Phase Ii Clinical Trial and Clinical Hold Issued by the United States FDA INmune Bio Inc. is on track to complete enrollment of its Phase II clinical trial in patients with early Alzheimer's Disease and biomarkers of inflammation in 2024. TheCompany received notification by the FDA that the US Phase II trial remains on full clinical hold pending a request for additional information on long-term potency. The request came following the most recent submission to the FDA that showed a possible increase in the long-term potency of XPro(TM) . The Company will provide clarification to the FDA in a response before the end of the year that it believes will resolve the remaining questions. The trial is open in Australia, Canada, the United Kingdom, Poland, France, Spain and is expected to open soon in several additional EU countries. To date, the FDA remains the only regulatory agency to put the Phase II clinical trial on hold. Ankündigung • Nov 30
Inmune Bio Inc. Demonstrates That INB03 Enhances the Uptake of Trastuzumab Deruxtecan in Her2+ Breast Cancer with Muc4 Expression in Poster Presented At San Antonio Breast Cancer Symposium INmune Bio, Inc. is presenting data on the use of INB03, a dominant-negative TNF inhibitor of soluble TNF (sTNF) in the treatment of high-risk MUC4 expressing HER2. Roxana Schillaci, Ph.D., of Instituto de Biología y Medicina Experimental in Buenos Aries, Argentina, will present her work at the 46th annual San Antonio Breast Cancer Symposium, which runs from December 5 to 9. INB03 decreases resistance to T-DXd therapy in three ways. INB03 decreases MUC4 expression on the surface of the breast cancer cells increasing the ability of the antibody to bind to the HER2 target on the cancer cell. The combination of low-dose (1.5mg/kg) T-DXd+INB03 decreases tumor growth as much as full dose (5mg/kg) T-DXd alone suggesting increased binding of the immunotoxin to the cancer cell improves anti-tumor effects. INB03 increases internalization of T-DXd and converts the immunosuppressive TME into one that is more tumor-sensitive by polarizing tumor associated macrophages (TAM) from M2-like to M1-like phenotype with increased expression of IFNg. The poster concludes that the combination of INB03 may allow for lower doses of T-DXd to be effective in women with MUC4 expressing HER2+ breast cancer and that addition of INB03 may improve the response to T-DXd in women with resistant HER2+ disease. Ankündigung • Nov 29
INmune Bio, Inc. Receives EMA's Authorization in France and Spain for Phase II Clinical Trial of XPro for Early Alzheimer's Disease INmune Bio, Inc. announced it has received European Medicines Agency's (EMA) Authorized Decision from the Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) in France and the Agence Espanola de Medicamentos y Productos Sanitarios (AEMPS) in Spain to initiate a Phase II trial in Early Alzheimer's Disease (AD) with XPro. This authorization follows the acceptance of the Company's Clinical Trial Application (CTA) under EU Clinical Trials Regulation and prior EMA's Authorized Decision in Poland on Nov. 15, 2023. The Spanish and French arms are part of the Company's international clinical development strategy for XPro™? in patients with early AD. The Phase II clinical trial is a global, multi-center, randomized clinical study in patients diagnosed with early Alzheimer's disease who have biomarkers of elevated inflammation. In a prior Phase I open-label trial, INmune Bio met all primary and secondary endpoints. Patients with AD who received XPro demonstrated notable decreases in neuroinflammation, enhanced axonal integrity, and improved synaptic function. Employing advanced MRI imaging techniques enabling a "virtual biopsy" of the brain, treatment with XPro™? demonstrated improvements in the structural integrity of both gray and white matter in the brain. XPro(XPro1595, pegipanermin) is a next-generation selective inhibitor of tumor necrosis factor (TNF) that is currently in clinical trials and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF or TNF receptors. XPro could potentially have substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation, decreasing neurodegeneration while improving synaptic function and promoting remyelination. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio's website. Ankündigung • Nov 17
INmune Bio Inc. Announces Expansion of Phase II Clinical Trial for Alzheimer's Disease in Europe INmune Bio, Inc. has received acceptance of a Clinical Trial Application (CTA) under EU Clinical Trials Regulation to initiate a Phase II trial in Early Alzheimer's Disease (AD) with XPro(TM) in Poland. Additional regulatory approval for the Phase II AD clinical trial is expected from at least two to potentially six more EU countries in the upcoming months. The EU approval is part of the Company's international clinical development strategy for XPro(TM) in patients with early AD. The trial is currently enrolling patients in Australia, Canada, and the United Kingdom. The Phase II clinical trial is a global, multi-center, randomized clinical study in patients diagnosed with early Alzheimer's disease who have biomarkers of elevated inflammation. In a prior Phase I open-label trial, INmune Bio met all primary and secondary endpoints. Patients with AD who received XPro(TM) demonstrated notable decreases in neuroinflammation, enhanced axonal integrity, and improved synaptic function. Employing advanced MRI imaging techniques enabling a "virtual biopsy" of the brain, treatment with XPro(TM) demonstrated improvements in the structural integrity of both gray and white matter in the brain. These funds provide a non-dilutive funding source, allowing INmune to reinvest in expanding recruitment and enrollment not only in Australia and Canada but also in newer locations in the U.K. and the EU. Major Estimate Revision • Nov 08
Consensus revenue estimates increase by 30%, EPS downgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$110.0k to US$150.0k. EPS estimate fell from -US$1.60 to -US$1.76 per share. Biotechs industry in the US expected to see average net income growth of 1.4% next year. Consensus price target of US$17.33 unchanged from last update. Share price fell 2.2% to US$7.13 over the past week. Reported Earnings • Nov 03
Third quarter 2023 earnings: Revenues exceed analysts expectations while EPS lags behind Third quarter 2023 results: US$0.48 loss per share (further deteriorated from US$0.43 loss in 3Q 2022). Net loss: US$8.56m (loss widened 11% from 3Q 2022). Revenue exceeded analyst estimates by 180%. Earnings per share (EPS) missed analyst estimates by 22%. Revenue is forecast to grow 95% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 11% per year whereas the company’s share price has fallen by 7% per year. Ankündigung • Nov 01
Inmune Bio, Inc. Announces Update Regarding Patent Claims Covering Inb16 Cell Line INmune Bio, Inc. announced an update regarding the company's patent covering its proprietary cell line, "INB16", as well as the therapeutic composition comprising replication-incompetent INB16 cells known as "INKmune™" and methods of treating cancer by administering INKmune™, with a goal of achieving in vivo priming of natural killer (NK) cells to enhance the ability of a patient's own NK-cells to effect cancer surveillance, recognition, and killing. In the written opinion for the international patent application titled, "HUMAN T-CELL ACute LYMPHOBLASTICLEUKEMIA CELL LINE & APPLICATIONS FOR TREating CANCER," an examiner from the International Search Authority at the United States Patent & Trademark Office, authorized by the World Intellectual Property Organization under the Patent Cooperation Treaty, issued a favorable patentability opinion with respect to novelty, inventive step and industrial applicability of all claims and concluding that the application contains patentable subject matter. The Company intends to leverage the favorable written opinion under the patent prosecution highway, a program offered by the USPTO, EPO and other participating patent offices to accelerate examination and ultimately patent issuance for inventions receiving favorable opinions received from certain patent authorities, including WIPO. INmune™ therapy does not require any type of conditioning, pre-medication or cytokine support. Ankündigung • Oct 18
INmune Bio, Inc. Presents New Biomarker and Feasibility Data from Phase 1b Study Supporting the Use of XPro™ to Treat Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease Conference INmune Bio, Inc. highlights some important findings from data presented at the 16th annual Clinical Trial in Alzheimer's Disease (CTAD) to be held October 24-27 in Boston, MA. INmune is enrolling AD patients into a global, blinded, randomized Phase II trial. Summary of CTAD Presentations featuring XPro: P186: Feasibility of the Cumulus electrophysiological neurocognitive platform to enable de-centralized trials in Alzheimer's Disease. The poster reports regional improvements in a difference MRI measure of cortical grey matter quality after short-term treatment with XPro, in grey matter structures that are most affected by AD suggesting that XPro targets the regions of the brain most affected by AD. P055: Changes in cortical microstructure in brain regions associated with cognitive status and disease duration after short-term treatment with XPro1595 for Alzheimer’s disease. The poster reports regional improvements in a diffusion MRI measure of cortical grey matter quality after short-term treatment with XPro™, in grey matter structures that are most affected by AD suggesting that XPro™ targets the regions of the brain most affected by AD. Ankündigung • Oct 17
INmune Bio, Inc. to Report Q3, 2023 Results on Nov 01, 2023 INmune Bio, Inc. announced that they will report Q3, 2023 results on Nov 01, 2023 Ankündigung • Sep 06
Inmune Bio Inc. Announces Approval of Clinical Trial Application by the U.K. Medicines and Healthcare Products Regulatory Agency for Phase 2 Clinical Trial in Alzheimer’S Disease INmune Bio, Inc. received authorization of its Clinical Trial Application (CTA) by the Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 2 trial in Early Alzheimer’s disease (AD) with XPro™. The U.K. CTA is part of the Company’s international clinical development strategy for XPro™ in patients with early AD. The trial is also enrolling patients in Australia and Canada. The AD02 Phase 2 clinical trial is a global, multi-center, randomized clinical study in patients diagnosed with early Alzheimer's disease. In a prior Phase I open-lab trial, INmune Bio met all primary and secondary endpoints. AD patients treated with XPro™ exhibited significant reductions in neuroinflammation, improved axonal integrity, and improved synaptic function. Using sophisticated MRI imaging techniques that allow a “virtual biopsy” of the brain, treatment of XPro™ demonstrated improvements in the structural integrity of both gray and white matter in the brain. The UK has one of the highest rates of AD in the western world (47 cases per 100,000 patients) with almost one million patients diagnosed with dementia. In 2021, the estimated cost of dementia care in the UK was £25 billion. Dementia is expected to be the costliest health condition by 2030 and the UK is not in a unique situation. Globally, the number of people living with dementia is projected to triple by 2050. As a result of the quality of its medical research and the presence of the National Health Service, the UK plays an important role in advancing therapies for AD. Major Estimate Revision • Aug 14
Consensus revenue estimates increase by 51% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$80.0k to US$110.0k. Forecast losses expected to reduce from -US$1.73 to -US$1.60 per share. Biotechs industry in the US expected to see average net income decline 13% next year. Consensus price target of US$17.33 unchanged from last update. Share price fell 5.0% to US$8.32 over the past week. Reported Earnings • Aug 08
Second quarter 2023 earnings: EPS and revenues exceed analyst expectations Second quarter 2023 results: US$0.36 loss per share (improved from US$0.38 loss in 2Q 2022). Net loss: US$6.50m (loss narrowed 4.9% from 2Q 2022). Revenue exceeded analyst estimates. Earnings per share (EPS) also surpassed analyst estimates by 9.2%. Revenue is forecast to grow 88% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has only fallen by 7% per year, which means it has not declined as severely as earnings.