Boca Raton, Florida, October 21st, 2026, FinanceWire

• 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
• US BLA expected to be submitted in Q2, 2027

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 revised prior guidance to indicate that 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 from prior guidance.

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 www.inmunebio.com.

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

Contact

Head of Investor Relations
Daniel Carlson
dcarlson@inmunebio.com
(415) 509-4590

Boca Raton, Florida, October 21st, 2026, FinanceWire

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 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.com

Daniel 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

Contact

Uniphar
NPS_Ebstrocel@uniphar.com

Warnickshire, UK, October 21st, 2026, FinanceWire

Data Accounting Highlights Its Approach to Financial Investigations and Announces International Expansion and AI Assistant Launch

Supporting financial transparency through forensic accounting, cross-border financial analysis, and assistance for individuals affected by financial losses.

Data Accounting continues to develop its capabilities in financial analysis, forensic accounting, and international compliance, helping businesses and individuals navigate complex financial situations.

As part of its international development strategy, Data Accounting is preparing to expand its presence across the United Arab Emirates, Australia and Singapore in late 2026 and early 2027. The planned expansion reflects the firm’s intention to broaden its international reach and support individuals and businesses dealing with complex financial matters across different jurisdictions.

Alongside this expansion, Data Accounting is developing a new AI-powered assistant, scheduled for launch in the first quarter of 2027. The assistant is intended to help individuals who have suffered financial losses, including those arising from potentially unsuitable financial advice or unclear regulatory processes, identify the nature of their concerns, organize relevant information and prepare their cases for review by Data Accounting’s team. The initiative aims to make the initial assessment process more accessible and help individuals understand what information may be relevant to their circumstances.

As financial transactions become increasingly international, the need for accurate documentation, reliable financial records, and effective oversight continues to grow. Data Accounting focuses on examining financial information, reviewing transaction histories, and identifying inconsistencies that may require further investigation or clarification.

Its work encompasses the analysis of financial statements, accounting documentation, tax-related records, and cross-border fund movements. Through structured review procedures and analytical techniques, the firm aims to help identify discrepancies, improve financial transparency, and support informed decision-making.

Forensic accounting can play an important role in understanding unusual transaction patterns, assessing the completeness of financial records, and identifying potential weaknesses in accounting or compliance procedures. Where concerns arise, a systematic examination of the available evidence can help clarify the circumstances and determine whether further professional or legal review may be appropriate.

Financial Support for Businesses and Individuals

Financial difficulties can affect both businesses and private individuals. In particular, individuals who have suffered financial losses may face uncertainty when trying to understand what happened, establish the status of their funds, or determine what options may be available to them.

Data Accounting aims to assist individuals affected by financial losses by helping them review relevant financial documentation, organize transaction records, and examine the circumstances surrounding their cases. This includes cases in which individuals have concerns about financial advice they received or difficulties understanding regulatory processes. Depending on the situation, this work may help identify discrepancies, clarify the movement of funds, and establish a clearer picture of the available evidence.

The planned AI assistant will provide an additional starting point for individuals seeking to explain their circumstances and organize information for assessment by the firm’s team. Each case will require an individual review, and potential next steps will depend on the circumstances, the documentation available, and the relevant legal and regulatory framework. Where appropriate, individuals may need to seek independent legal advice or contact the relevant financial institution or competent authority.

For businesses, sound financial oversight remains equally important. Companies operating across borders often manage international suppliers, overseas payments, multi-country payroll arrangements, and complex tax obligations. Weak documentation or inadequate internal controls can create financial uncertainty, operational difficulties, and compliance risks.

Data Accounting supports businesses seeking assistance with international accounting, tax advisory, financial reviews, and administrative processes. Its approach emphasizes accurate record-keeping, structured analysis, and the identification of potential weaknesses that may benefit from further attention.

Supporting Transparency Through Financial Analysis

Financial investigations require attention to detail, a methodical approach to evidence, and a clear understanding of accounting principles and applicable compliance requirements.

Data Accounting’s services focus on helping clients assess financial information, examine unusual transaction patterns, and obtain greater clarity regarding accounting and administrative matters. Depending on the circumstances and the scope of an engagement, this work may support internal reviews, financial assessments, or further independent professional examination.

By helping clients organize documentation and understand complex financial information, the firm seeks to support more informed decisions and improved financial accountability.

The planned international expansion and AI assistant launch represent further steps in Data Accounting’s development, combining its existing financial analysis capabilities with new ways for individuals and businesses to engage with the firm.

About Data Accounting

Data Accounting provides financial and accounting-related services for businesses and individuals seeking greater clarity and transparency in financial matters. Its areas of focus include international accounting, tax advisory, financial analysis, administrative support, and forensic accounting-related reviews.

The firm aims to help clients understand complex financial information, improve documentation practices, examine financial discrepancies, and identify opportunities to strengthen accounting and compliance procedures.

For more information about Data Accounting and its services, visit https://data-accounting.com/.

Contact

Jackie Cox
Data Accounting
reception@mail-data-accounting.com