O04 Mission EB -mesenchymal intravenous stromal cell infusions in children with recessive dystrophic epidermolysis bullosa: a randomised, double-blinded, placebo controlled, crossover trial

Article

作者: Petrof, Gabriela ; Bursnall, Matt ; Hutchence, Katie ; Martinez, Anna E ; Papaioannou, Diana ; Biggs, Katie ; Ogboli, Malobi ; Poudel, Pratima ; Lovgren, Marie-Louise ; Glover, Rachel ; López Balboa, Pablo ; Nadeem, Muna ; Julious, Steven ; Cooper, Cindy ; McGrath, John ; Ditta, Shamila ; Wilson, Isabelle ; Bageta, Maria L

Abstract:

Recessive Dystrophic Epidermolysis Bullosa (RDEB) is a severe type of epidermolysis bullosa resulting from mutations in COL7A1 gene. Patients experience various degrees of blistering following minor trauma which can over time lead to fibrosis, limb contractures and an increased risk of developing squamous cell carcinoma. The aim was to assess if repeated infusions of allogeneic umbilical cord derived mesenchymal stromal cells (UC-MSCs), CORDStromTM, were safe and could benefit children with RDEB.This was a prospective, double-blinded, randomised, placebo-controlled crossover trial with an internal dose de-escalation trial (for safety) conducted at the two National Paediatric UK EB centres in RDEB children aged >6months and <16years.Participants received IV infusions of 2–3 × 106 cells/kg of UC-MSCs or placebo at day 0 and 14 days later with a 9-month wash out period between the opposite.Main outcomes were change in disease severity as measured by the Epidermolysis Bullosa Disease Activity and Scarring index (EBDASI) and the Instrument for Scoring Clinical Outcomes of Research for Epidermolysis Bullosa (ISCOREB), wound clinical appearance, pain, itch, and quality of life at 3-months from infusion. Results will be discussed at the meeting.This is the largest study worldwide in children with RDEB. Administering cell therapy early and at regular intervals has the potential to reduce inflammation, effectively modulate disease activity, and lead to clinically meaningful and sustained improvements in disease progression and quality of life. An open-label study is planned and will help us further evaluate the long-term safety and outcomes of CORDStromTM infusions in children with RDEB.

2025-10-01·EClinicalMedicine

Mesenchymal stromal cell infusions of umbilical cord-derived mesenchymal stromal cells in children with recessive dystrophic epidermolysis bullosa (MissionEB): a randomised, double-blind, placebo controlled, crossover, phase 3 trial with an internal phase 1 dose de-escalation phase

Article

作者: Tappenden, Paul ; McGrath, John A ; Wilson, Isabelle ; Turton, Emily ; Papaioannou, Diana ; Ditta, Shamila ; Bursnall, Matt ; Nadeem, Muna ; Biggs, Katie ; Ogboli, Malobi ; Lovgren, Marie-Louise ; Lopez-Balboa, Pablo ; Glover, Rachel ; Poudel, Pratima ; Cooper, Cindy ; Julious, Steven ; Hutchence, Kate ; Petrof, Gabriela ; Martinez, Anna E ; Bageta, Maria L

Background:

Recessive dystrophic epidermolysis bullosa (RDEB) is a rare genetic disorder characterised by extensive mucocutaneous blistering. This study aimed to generate evidence to inform commissioning decisions on umbilical cord-derived mesenchymal stromal cells, UC-MSCs, (CORDStrom™) for RDEB.

Methods:

In this double-blinded, randomised (1:1), placebo-controlled, two-period crossover phase 3 trial, children aged 6 months to 16 years of age with RDEB were enrolled at two UK specialist centres for epidermolysis bullosa (EB). Individuals were excluded if they had received oral or topical corticosteroids for more than 7 consecutive days within 30 days of enrolment into this study, excluding oral viscous budesonide and inhaled fluticasone used as prophylaxis to relieve oesophageal symptoms, an active infection that required treatment with oral or intravenous antibiotics within 7 days of screening, medical history or evidence of active malignancy, the presence of both positive collagen VII ELISA and a positive indirect immunofluorescence (IIF) with binding to the base of salt split skin, administration of MSCs from any source in the previous 9 months and participation in any other interventional trial within 3 months of enrolment into this study. This trial included an internal dose de-escalation (IDD) phase for safety gatekeeping. During IDD, 4 participants were randomised (3:1) to receive two infusions (2-3 × 10⁶ cells/kg/infusion or placebo) on days 0 and 14 before the next participant begun treatment. The primary outcome was toxicity defined as a suspected unexpected serious adverse reaction (SUSAR) within 48 h of receiving an infusion. The DMEC reviewed the data and if one (or fewer) patients receiving the active treatment experienced a SUSAR, the dose would be reduced and toxicity evaluated in a further 5 patients randomised (3:2) to UC-MSCs or placebo. If there were no further toxicities, the trial progressed to the main two period crossover study. In the main crossover, patients were randomly assigned (1:1) using a web-based randomisation system SCRAM to receive two intravenous infusions (days 0 and 14), at a dose of 2-3x10⁶ cells/kg UC-MSCs or placebo. There were 2 follow-up periods each of 6 months with a 3 month interval between periods, giving a 9 month duration between doses. Clinicians, caregivers, patients, and clinical trial personnel were fully blinded to treatment groups. Trial pharmacists and a team or independent research nurses who only performed administration of the infusion were unblinded to perform security checks of the product but were not involved in any assessments. The primary endpoint was change in disease severity as measured by Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI) at three months post infusion assessed in the modified intention to treat (mITT) population (participants providing data at both period baselines and at least one 3-month follow-up). Prespecified subgroups included RDEB severity and age. Safety data were collected for all participants and safety assessment was based on all treatment emergent events in the safety population (those receiving at least one active or placebo infusion). This trial is registered with ISRCTN, ISRCTN14409785.

Findings:

Between OCT 06, 2021, and JUL 15, 2024, 44 participants were screened; 37 were randomised (18 UC-MSCs/placebo; 19 Placebo/UC-MSCs), with 34 receiving at least one infusion and 30 in the mITT analysis (14 UC-MSCs/placebo; 16 placebo/UC-MSCs). No toxicities were seen in the IDD phase (primary outcome). At three months no changes in favour of UC-MSCs were seen in the primary outcome EBDASI. The between arm difference in EBDASI at 3 months showed a 3.75 point difference (effect size 0.06) in favour of placebo (95% CI of -1.46, 8.96, p = 0.15) with corresponding figures for UC-MSCs/Placebo and Placebo/UC-MSCs of 5.5 (95% CI of -2.53 to 13.53, p = 0.16) and 2 (95% CI of -5.33 to 9.33, p = 0.58). No serious adverse events were associated with UC-MSCs.

Interpretation:

UC-MSCs infusions were safe and the primary outcome (EBDASI) did not show MSCs were beneficial. Further evaluation of the long-term efficacy of UC-MSCs is planned. The main strength is that Mission EB is the largest cell therapy study to date providing the most robust evidence on the safety and efficacy of UC-MSCs in children with RDEB. A limitation is that there are no robust validated outcome measures for RDEB.

Funding:

National Research Collaboration Programme, an NHS England and NIHR partnership (NIHR 127963) and Cure EB.

项与 CORDStrom 相关的新闻（医药）

2026-10-21

·GlobeNewswire-Health Care

INmune Bio Establishes Global Commercialization Framework for Ebstrocel™ Through Strategic Agreement with Uniphar

Initial focus on named-patient access in selected European and MENA markets, providing a capital-efficient foundation for broader commercialization BOCA RATON, Fla., Oct. 21, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced that it has entered into a Master Services Agreement with Uniphar Durbin Ireland Limited (“Uniphar”) establishing a scalable framework to support international access, distribution and commercialization of Ebstrocel™, the Company’s allogeneic stromal cell therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB). INmune Bio initially intends to use the framework to pursue named-patient access in selected European countries and in the Middle East and North Africa (MENA), subject to applicable law and country-specific statements of work. The relationship may subsequently expand across Europe and other territories by mutual agreement. The Company expects named-patient access to be an important component of its international commercialization strategy for Ebstrocel™. Where permitted by local law and implemented through statements of work, this pathway may allow physicians to request Ebstrocel™ for individual eligible patients before local marketing approval or broad commercial availability. The Uniphar framework is designed to provide the Company with scalable international commercial infrastructure, beginning with named-patient supply, and potentially expanding to broader commercial distribution as regulatory approvals, pricing and reimbursement are secured in individual countries. Depending on the services agreed in individual statements of work, Uniphar may support regulatory feasibility assessments, market access, product storage and distribution, healthcare-provider and treatment-site onboarding, order-to-cash services, medical information, pharmacovigilance support and end-to-end shipment tracking. By leveraging Uniphar’s established infrastructure rather than building country-by-country capabilities internally, the Company believes this model provides a capital-efficient path to establish Ebstrocel™’s international commercial footprint and scale as additional markets become available. “This agreement marks an important step in moving Ebstrocel™ from clinical development toward commercialization and bringing Ebstrocel to patients internationally,” said David Moss, Chief Executive Officer of INmune Bio. “Uniphar provides access to established market-access, distribution and order-to-cash capabilities across multiple international markets without requiring INmune Bio to build those capabilities country by country. We believe this provides a capital-efficient way to pursue named-patient opportunities in appropriate markets while building the physician relationships, treatment-center experience and commercial infrastructure needed to support broader international commercialization.” “We are pleased to partner with INmune Bio as it prepares Ebstrocel for international commercialization,” said Ruth Rostron, Head of Expanded Access at Uniphar. “Uniphar has built an integrated global platform to help innovative medicines navigate the complexities of international access, distribution and commercialization. We believe our infrastructure and experience are well suited to support INmune Bio’s strategy for Ebstrocel, beginning with named-patient access opportunities and expanding as the product progresses through its regulatory and commercial journey.” About Ebstrocel™ Ebstrocel™ (pobistrocel) is INmune Bio’s investigational, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell therapy being developed through the Company’s CORDStrom™ platform for the treatment of RDEB. The platform is designed to address donor variability and manufacturing inconsistency. Ebstrocel™ is investigational and has not been approved by the FDA, MHRA, EMA or any other regulatory authority. About Uniphar Plc. Uniphar is a trusted global partner to pharma, medtech and biotech, delivering solutions that connect medicines and technologies with patients worldwide. With over 57 years of experience and partnerships with 200+ multinational clients, Uniphar combines deep expertise, global infrastructure and market insight to meet the evolving needs of the life sciences sector. Uniphar Pharma integrates Development, Clinical, Access, Medical, Commercial, Distribution and Global Sourcing to support the full product lifecycle – from early-stage research through to commercialization and beyond. Uniphar’s unified platform spans regulatory strategy, clinical trial support, medical affairs, market access, patient engagement, commercial services, distribution and supply chain. Operating across 160 countries with a global team of 3,600+, Uniphar bridges manufacturers, healthcare providers, and patients — accelerating access to innovative therapies, improving patient outcomes, and delivering value across the healthcare ecosystem. From molecule to market and beyond. For more information, please visit www.uniphar.com About INmune Bio Inc. INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. Moving beyond early-stage exploration, the Company’s clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes. INmune Bio is actively advancing two late-stage product platforms toward registrational milestones: CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning toward regulatory and commercial readiness, with an MAA planned for the UK MHRA in 2026 and EU EMA in 2027, alongside a planned U.S. regulatory pathway and development of international access and distribution infrastructure. XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform that selectively neutralizes soluble TNF (sTNF) to reduce pathological neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease. To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit www.inmunebio.com. Forward Looking Statements The Company’s product candidates are investigational, and there can be no assurance that any clinical, regulatory or commercial objective will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, timing of key milestones, future plans or expectations, the scope and implementation of the Uniphar relationship, the execution of statements of work, the availability and timing of named-patient or expanded-access sales, potential revenue, potential expansion across Europe, the Middle East and North Africa (MENA) or into Latin America, the anticipated capital efficiency of the distribution model, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDStrom™ (EbstrocelTM, pobistrocel), XPro1595™ (XPro™, pegipanermin), and INKmune™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA 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 substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release. INmune Bio Contacts: David Moss Chief Executive Officer (561) 710-0512 info@inmunebio.comDaniel Carlson Head of Investor Relations (415) 509-4590 dcarlson@inmunebio.com Uniphar Contacts:Media Contacts:Uniphar: Heather.Hopkin@teamtala.com and Beth.Oshea@teamtala.com Enquiries:Uniphar: NPS_Ebstrocel@uniphar.com

快速通道细胞疗法免疫疗法

2026-10-21

·BioSpace

INmune Bio Advances Ebstrocel™ Toward Potential UK Approval in Mid-2027

Final pre-MAA package submitted to MHRA on October 20, 2026 Full MAA submission targeted for early February 2027, under a revised strategy that could bring potential UK approval forward by approximately six weeks U.S. BLA expected to be submitted in Q2, 2027 BOCA RATON, Fla., Oct. 21, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced that it has submitted its final pre-Marketing Authorisation Application (pre-MAA) package to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Ebstrocel™ (CORDStrom™), its investigational cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). The company has updated its regulatory submission strategy, as faster-than-expected manufacturing progress supports a full MAA submission in early February 2027, with potential UK approval in mid-2027, subject to MHRA review. Following MHRA feedback on the final pre-MAA package, INmune Bio plans to finalize and submit a complete application in February 2027, replacing the sequential rolling submission previously planned to begin in late 2026. Based on progress in chemistry, manufacturing and controls (CMC) and discussions with regulatory advisors, the Company believes this approach could accelerate potential UK approval by approximately six weeks compared with the previously anticipated timeline. The Company anticipates an MHRA response within three to six months after submission, subject to application validation, agency review and any requests for additional information. Submission of the complete package is intended to support assessment of the clinical, manufacturing and quality data together. “This is a remarkable achievement by the whole CMC team and our external regulatory advisors allowing us to accelerate the potential approval for Ebstrocel for children with RDEB,” said Mark Lowdell, Chief Scientific Officer of INmune Bio. “Our progress allows us to bring forward the anticipated timeline to commercial supply, subject to approval, for children and families waiting for treatment.” In parallel, INmune Bio has engaged U.S. regulatory advisors with rare disease expertise to prepare and submit a Type B meeting request to the U.S. Food and Drug Administration (FDA). Subject to feedback from that meeting, the Company plans to submit a Biologics License Application (BLA) in the second quarter of 2027, seeking traditional or accelerated approval, as appropriate. “Based on positive feedback from our regulatory consultants in the U.S, we are prioritizing our FDA application ahead of an EMA submission, building on Ebstrocel’s U.S. Orphan Drug and Rare Pediatric Disease designations,” said David Moss, Chief Executive Officer of INmune Bio. “With potential UK and U.S. approvals in 2027, we are approaching a pivotal year. Approval in either or both markets would mark a major milestone for INmune Bio and bring Ebstrocel closer to patients and families living with RDEB.” About INmune Bio Inc. INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. The Company’s clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes. INmune Bio is actively advancing two late-stage product platforms toward registrational milestones: CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning to regulatory filing phases, with an MAA planned for the UK MHRA in 2026 and EU EMA in 2027, alongside a planned U.S. Biologics License Application (BLA) submission. XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform designed to selectively neutralize soluble TNF (sTNF) and reduce neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease. To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit . Forward Looking Statements The Company’s product candidates remain in clinical development stage and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including Ebstrocel™, XPro™ and INKmune™ trial results, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDStrom™, XPro1595™ (XPro™, pegipanermin), and INKmune™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA 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 substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release. INmune Bio Contacts: David Moss Chief Executive Officer (561) 710-0512 info@inmunebio.com Daniel Carlson Head of Investor Relations (415) 509-4590 dcarlson@inmunebio.com

快速通道孤儿药临床研究免疫疗法细胞疗法

2026-10-14

·BioSpace

INmune Bio Inc. and Quantum Computing Inc. Partner to Apply Quantum Optimization and AI to Advance Alzheimer’s Drug Research and Explore New Applications for XPro ™

· Collaboration combines INmune Bio's clinical research with QCi's Dirac-3S quantum optimization machine to identify potential new treatment indications and biomarkers for XPro · Initial engagement marks QCi's first commercial customer in pharmaceutical and biotechnology markets, expanding the application of quantum computing to drug development BOCA RATON, Fla. and HOBOKEN, N.J., October 14, 2026 — INmune Bio Inc. (Nasdaq: INMB) and Quantum Computing Inc. (Nasdaq: QUBT) to day announced a collaboration to apply quantum computing, artificial intelligence (AI) and data analytics to identify new potential applications for XPro (XPro1595), INmune Bio's investigational treatment for Alzheimer's disease and other disease conditions. The collaboration brings together INmune Bio's data from pre-clinical research through four clinical trials and understanding of disease biology with QCi's Dirac-3S quantum optimization machine. Working with clinical and publicly available biomedical datasets, the companies intend to use quantum computing alongside AI and conventional data analytics to uncover relationships that could help find diseases driven by the same biology XPro targets, and to prioritize those with the greatest potential for success. The Stage 1 engagement represents QCi's first commercial customer in the pharmaceutical and biotechnology market. The agreement also provides options for additional work as INmune Bio advances its clinical development programs. "We've built a large clinical dataset on Alzheimer’s and other diseases, backed by years of work with XPro," said David Moss, Chief Executive Officer of INmune Bio. "This collaboration allows us to examine patient populations and biomarkers most likely to predict responses by analyzing large data sets. We'll look for the diseases with the greatest potential for success, those whose human biology matches what we've already seen XPro do, starting with rare diseases where trials can be smaller, faster and more capital-efficient, and where qualifying pediatric approvals may earn a Priority Review Voucher." Together, the companies will build on INmune Bio's research into XPro to explore where its approach to targeting inflammation may offer the greatest potential. XPro is designed to selectively inhibit soluble tumor necrosis factor (TNF), a protein involved in inflammation, while preserving other TNF functions important to the immune system. INmune Bio is investigating its potential in neurological and rare diseases where this targeted approach may offer a therapeutic benefit. Using its Dirac-3S entropy quantum optimization machine alongside AI and conventional analytics, QCi will look for patterns and relationships across these datasets that could help researchers better understand treatment responses, identify promising patient populations and prioritize new indications for further study. “This is a great example of what practical quantum computing can look like today,” said Yuping Huang, Chairman and Chief Executive Officer of QCi. “INmune Bio has a complex scientific problem and a substantial body of clinical and biological data. Our job is to bring new computing capabilities to that problem and see what we can learn. The potential to help researchers make better decisions about future treatments is exciting, and it opens an important new market for QCi.” An important part of the program will be testing where quantum optimization adds value. The companies plan to compare results from QCi's quantum optimization machine with appropriate conventional statistical and machine-learning methods, evaluating which approaches are best suited to different parts of the analysis. The work is also intended to establish a repeatable discovery process through quantum computing that INmune Bio can use with additional datasets and potential disease indications. For INmune Bio, the collaboration offers a new way to evaluate the broader potential of XPro and prioritize future development opportunities. For QCi, it represents an opportunity to showcase how its room-temperature, low-power quantum computing technology can be applied to complex, real-world problems in pharmaceutical research. About INmune Bio Inc. INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. The Company’s clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes. INmune Bio is actively advancing two late-stage product platforms toward registrational milestones: CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning to regulatory filing phases, with an MAA planned for the UK MHRA in 2026 and EU EMA in 2027, alongside a planned U.S. Biologics License Application (BLA) submission. XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform designed to selectively neutralize soluble TNF (sTNF) and reduce neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease. To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit . About Quantum Computing Inc. Quantum Computing Inc. (Nasdaq: QUBT) is an integrated quantum photonics company developing and manufacturing technologies that use light to compute complex information, capture hard-to-detect signals and communicate more securely. QCi brings together quantum optics, integrated photonics, semiconductor manufacturing and advanced packaging to create a more direct path from advanced science to practical products. QCi's portfolio includes quantum machines, photonic chips, components, modules and subsystems, as well as foundry and advanced manufacturing services. Its technologies are designed to operate at room temperature and low power, without the specialized cooling infrastructure required by many quantum approaches. These advantages enable deployment across computing and AI, secure communications, sensing and imaging, aerospace and defense, and other demanding applications. Headquartered in Hoboken, New Jersey, QCi has operations across the United States. By combining advanced physics, device engineering and scalable manufacturing, QCi is working to make quantum and advanced photonic technologies more accessible and useful in the real world. To learn more about QCi and its approach to harnessing light for practical quantum computing, please visit . Investor and Media Contacts: For INmune Bio: David Moss, Chief Executive Officer (561) 710-0512 info@inmunebio.com Daniel Carlson, Head of Investor Relations (415) 509-4590 dcarlson@inmunebio.com For QCi: David Moskowtiz, Head of Investor Relations investors@quantumcomputinginc.com Karen Jeffers, Director, Marketing and Communications media@quantumcomputinginc.com John Nesbett/Zach Nevas, IMS Investor Relations qci@imsinvestorrelations.com Forward Looking Statements: InMune Bio Inc. The Company’s product candidates remain in clinical development stage and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including Ebstrocel™, XPro™ and INKmune™ trial results, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDStrom™, XPro1595™ (XPro™, pegipanermin), and INKmune™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA 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 substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release. Quantum Computing Inc. This press release contains forward-looking statements as defined within Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements and forecasts, generally identified by terms such as “may,” “will,” “expect,” “believe,” “anticipate,” “estimate,” “enhance,” “intends,” “goal,” “objective,” “seek,” “attempt,” “aim to,” or variations of these or similar words, involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief, or current expectations of QCi and members of its management as well as the assumptions on which such statements are based. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including QCi’s ability to use quantum optimization to analyze biomedical data, whether collaboration will generate relevant and valuable insights, the performance of the Dirac-3S in the intended application, the ability of quantum optimization to contribute to the development of new treatments, and that actual results may differ materially from those contemplated by such forward-looking statements. Except as required by federal securities law, QCi undertakes no obligation to update or revise forward- looking statements to reflect changed conditions.

100 项与 CORDStrom 相关的药物交易

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