INmune Bio Inc Issues Shareholder Letter Reviewing 2025 Milestones and Outlining 2026 Strategic Initiatives

Rhea-AI Summary

INmune Bio (NASDAQ: INMB) CEO David Moss reviewed 2025 progress and outlined 2026 priorities, highlighting clinical and regulatory milestones for two lead programs: CORDStrom for recessive dystrophic epidermolysis bullosa (RDEB) and XPro (XPro1595) for Alzheimer’s disease. Key 2025 items include three commercial pilot-scale manufacturing runs for CORDStrom, a planned MAA submission in mid‑summer 2026 to the UK MHRA and a targeted BLA submission late 2026 to FDA (timelines subject to regulatory feedback). XPro’s Phase 2 MINDFuL showed biomarker‑defined signals (EMACC effect size 0.27) guiding a precision‑medicine registrational path. Cash and equivalents were approximately $27.7M as of Sept 30, 2025, with financing and rebates expected to fund operations through year‑end 2026.

Positive

• Cash balance of approximately $27.7M as of Sep 30, 2025
• Three commercial pilot‑scale manufacturing runs completed for CORDStrom
• MAA planned mid‑summer 2026 to UK MHRA for CORDStrom
• XPro Phase 2 biomarker subgroup showed EMACC effect size 0.27

Negative

• Overall modified intent‑to‑treat population (n=200) did not meet primary endpoint
• Regulatory timelines (MAA/BLA) remain subject to feedback and manufacturing readiness
• Cash runway conservatively stated to last only through year‑end 2026

News Market Reaction

+7.78%

26 alerts

+7.78% News Effect

-11.4% Trough in 24 hr 5 min

+$3M Valuation Impact

$48M Market Cap

1.1x Rel. Volume

On the day this news was published, INMB gained 7.78%, reflecting a notable positive market reaction. Argus tracked a trough of -11.4% from its starting point during tracking. Our momentum scanner triggered 26 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $3M to the company's valuation, bringing the market cap to $48M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

MINDFuL mITT size: n=200 patients Biomarker subgroup size: n=100 patients EMACC effect size: 0.27 +5 more

8 metrics

MINDFuL mITT size n=200 patients Broader modified intent-to-treat population in Phase 2 Alzheimer’s trial

Biomarker subgroup size n=100 patients Amyloid-positive early AD with ≥2 inflammation biomarkers

EMACC effect size 0.27 Change from baseline vs placebo over 6 months in biomarker subgroup

Neuropsychiatric Inventory effect -0.24 Change from baseline vs placebo in biomarker-defined subgroup

pTau217 effect -0.18 Change from baseline blood pTau217 vs placebo in subgroup

Trial duration 6 months Duration of MINDFuL Phase 2 assessment cited for EMACC effect

Cash and equivalents $27.7 million As of September 30, 2025; stated to fund operations through year-end 2026

Planned MAA timing Mid-summer 2026 Targeted Marketing Authorization Application submission for CORDStrom™ to MHRA

Market Reality Check

Price: $1.59 Vol: Volume 255,842 vs 20-day ...

normal vol

$1.59 Last Close

Volume Volume 255,842 vs 20-day average 364,881 (relative volume 0.7x) shows subdued trading. normal

Technical Shares at $1.67 are trading below the $3.48 200-day moving average and far under the $11.64 52-week high.

Peers on Argus

INMB is down 1.76% while several biotech peers like JUNS (-6.25%), PYPD (-5.01%)...

2 Up

INMB is down 1.76% while several biotech peers like JUNS (-6.25%), PYPD (-5.01%), GNTA (-4.41%), and PDSB (-3.40%) are also lower, indicating broader sector weakness.

Historical Context

5 past events · Latest: Dec 05 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 05	Scientific publication	Positive	+1.3%	Peer-reviewed overview highlighting CORDStrom™ potential and 2026 BLA/MAA expectations.
Dec 01	Clinical data update	Positive	-10.1%	New MINDFuL Phase 2 grey-matter imaging data for XPro1595 in high-inflammation AD.
Nov 18	Conference presentations	Positive	+2.7%	Announcement of two CTAD presentations on MINDFuL results and EMACC validation.
Oct 30	Earnings and update	Neutral	-5.0%	Q3 2025 results with reduced net loss, $27.7M cash, and clinical progress updates.
Oct 23	Earnings preview	Neutral	+0.6%	Scheduling of Q3 2025 results call and webcast with access details for investors.

Pattern Detected

INMB’s news flow has mixed follow-through: positive clinical and scientific updates sometimes sold off (e.g., CTAD imaging data), while other scientific or corporate updates saw modest gains.

Recent Company History

Over the last few months, INMB has focused on advancing CORDStrom™ for RDEB and XPro1595 in Alzheimer’s disease. A Dec 5, 2025 peer-reviewed CORDStrom overview and expectations for 2026 BLA/MAA filings preceded a small gain. New MINDFuL grey-matter imaging data at CTAD on Dec 1, 2025 coincided with a double-digit decline, contrasting with modest positive reactions to CTAD presentation announcements and the Q3 2025 earnings call notice. Today’s shareholder letter reiterates and extends these clinical, regulatory, and financial themes.

Market Pulse Summary

The stock moved +7.8% in the session following this news. A strong positive reaction aligns with the...

Analysis

The stock moved +7.8% in the session following this news. A strong positive reaction aligns with the shareholder letter’s focus on tangible 2025 execution and defined 2026 milestones. Investors have seen mixed reactions to prior positive updates, such as the -10.06% move on CTAD imaging data versus a gain after the CORDStrom™ publication. If enthusiasm became extended, risks would include financing needs over time and the potential for sentiment to normalize once the impact of the shareholder letter and clinical comparisons is fully absorbed.

Key Terms

mesenchymal stromal cell, marketing authorization application (maa), biologics license application (bla), soluble tnf, +2 more

6 terms

mesenchymal stromal cell medical

"allogeneic umbilical cord-derived mesenchymal stromal cell therapy for recessive"

Mesenchymal stromal cells are a type of adult cell found in bone marrow, fat and other tissues that can act like a repair crew, supporting tissue healing, reducing inflammation and helping other cells grow. Investors care because these cells are the basis for many experimental therapies and diagnostics; clinical success, manufacturing scale-up, safety and regulatory approval determine commercial potential and can strongly affect a company’s valuation.

marketing authorization application (maa) regulatory

"updates on progress toward our Marketing Authorization Application (MAA), planned for"

A marketing authorization application (MAA) is a formal request submitted to a health regulator asking permission to sell a medicine or medical product in a market. Think of it like applying for a driver's license for a new drug: the regulator checks safety, quality and effectiveness before granting permission. For investors, the MAA stage matters because approval typically unlocks commercial sales and revenue, while rejection or delay creates major value and timing risk.

biologics license application (bla) regulatory

"we anticipate submitting a Biologics License Application (BLA) to the U.S. FDA"

A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.

soluble tnf medical

"proposed mechanism of action (MOA): selectively inhibiting soluble TNF to reduce"

Soluble TNF is the circulating form of tumor necrosis factor, a small signaling protein the immune system uses to call cells to action during inflammation. It matters to investors because levels of soluble TNF can serve as a measurable marker of disease activity and because many drugs aim to block it; changes in test results, trial outcomes or regulatory status for TNF-targeting therapies can directly affect a company’s value.

pTau217 medical

"blood levels of pTau217 (effect size −0.18). As is common in Phase 2"

ptau217 is a specific form of the brain protein tau that carries a small chemical tag at a particular spot (position 217) and can be measured in blood or spinal fluid as a signal of Alzheimer’s disease. It matters to investors because a reliable early signal — like a smoke alarm for brain changes — can speed drug trials, enable earlier diagnosis and create markets for tests and treatments, affecting the value of biotech and diagnostic companies.

neuroinflammation medical

"therapy for Alzheimer’s disease patients with neuroinflammation. MINDFuL was designed"

Neuroinflammation is the brain or spinal cord’s immune reaction to injury, infection, or abnormalities, where cells and molecules become active to protect or repair nervous tissue. It matters to investors because it underlies many neurological diseases and is a common target for drugs and diagnostic tools; positive or negative trial results, safety signals, or new therapies can change a company’s value much like a major repair plan or recall would affect a carmaker’s prospects.

AI-generated analysis. Not financial advice.

Boca Raton, FL, Jan. 27, 2026 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, presents the following letter to investors from David Moss, CEO:

Dear Fellow Shareholders,

As we reflect on 2025, I want to thank you for your continued support of INmune Bio. This past year marked an important period of execution, discipline, and focus as we advanced our mission to develop innovative therapies that address serious neuroinflammatory and immunologic diseases with high unmet needs. 2025 was a pivotal year for our company, highlighted by compelling clinical learnings from XPro™ in our Phase 2 Alzheimer’s disease trial and significant progress advancing CORDStrom™ in Recessive Dystrophic Epidermolysis Bullosa (RDEB). Our focus on harnessing the innate immune system to address conditions with large unmet need and meaningful market potential continues to drive us forward.

Starting with our most clinically advanced program, CORDStrom™, our patent-pending allogeneic umbilical cord-derived mesenchymal stromal cell therapy for recessive dystrophic epidermolysis bullosa (RDEB), 2025 saw substantial progress. A peer-reviewed study in December highlighted the therapeutic potential of CORDStrom™, aligning with our platform’s promise.(1)  We made significant strides in manufacturing, successfully completing three commercial pilot-scale runs at CGT Catapult in Stevenage, UK, in preparation for regulatory filings. I recently visited the Stevenage facility and saw firsthand the operational rigor and collaborative, problem-solving culture that is driving this program towards the patients and families living with RDEB.   The team provided detailed updates on progress toward our Marketing Authorization Application (MAA), planned for mid-summer 2026, including how we are actively managing bottlenecks both within and outside our direct control. Following the planned MAA submission to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), we anticipate submitting a Biologics License Application (BLA) to the U.S. FDA toward the end of 2026. These timelines remain subject to regulatory feedback and manufacturing readiness.

While Recessive Dystrophic Epidermolysis Bullosa (RDEB) has historically been classified by its visible cutaneous symptoms, its impact extends far beyond the skin. Because Type VII Collagen (COL7A) is a critical component of all squamous epithelia, the disease is fundamentally a systemic, multi-organ condition affecting the gastrointestinal tract, ocular surfaces, and internal organs. CORDStrom is designed to address this systemic pathology directly. Encouraged by recent clinical trial results, our team is working diligently toward a Marketing Authorization Application (MAA). We look forward to sharing further milestones regarding the CORDStrom-RDEB program throughout 2026.

In 2025, XPro™ (also known as XPro1595) delivered robust evidence supporting its potential as a differentiated therapy for Alzheimer’s disease patients with neuroinflammation. MINDFuL was designed as a short, biomarker-informed Phase 2 study intended to learn quickly and define the right population for a future registration-quality trial. While the broader modified intent-to-treat population (n=200) did not show a treatment effect, we observed meaningful and biologically consistent signals in a predefined subpopulation of amyloid-positive early AD patients with two or more biomarkers of inflammation (n=100). In this short trial and population, XPro™ showed benefits versus placebo on change from baseline EMACC (effect size 0.27), Neuropsychiatric Inventory (effect size −0.24), and blood levels of pTau217 (effect size −0.18). As is common in Phase 2 development, these results allow us to refine patient selection and statistical powering for the next study, and we are working with the FDA to define an appropriate registrational development path informed by these data.

Of note, there are precedents where a Phase 2 program in Alzheimer’s disease did not meet its primary endpoint yet demonstrated clinically meaningful signals that informed subsequent successful development and approval. For example, lecanemab’s Phase 2b BAN2401 program did not meet its 12-month Bayesian primary endpoint yet prespecified longer-duration analyses supported continued development and subsequent marketing approval.

In our biomarker-defined subpopulation, we observed a 0.27 effect size on the EMACC cognitive scale after only 6 months (2). For directional context, this magnitude compares favorably to the 18-month results of approved anti-amyloid therapies:

• Lecanemab (CLARITY-AD): 0.10 – 0.15 effect size at 18 months (3,5).
• Donanemab (TRAILBLAZER ALZ-2): ~0.19 effect size at 18 months (4,5).

While these comparisons use different endpoints (EMACC vs. ADAS-Cog) and trial designs, the data suggests a robust and rapid cognitive signal. These figures are intended for directional context and are not a direct measure of relative clinical benefit.

Additionally, the results from MINDFuL were supportive of XPro’s proposed mechanism of action (MOA): selectively inhibiting soluble TNF to reduce neuroinflammation while preserving beneficial TNF signaling. This included biomarker results such as reduced change from baseline blood pTau217 levels, as well as neuroimaging insights presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Diego in December 2025. Grey-matter MRI imaging analyses using PerpPD+ from Oxford Brain Diagnostics suggested imaging changes directionally consistent with reduced neurodegeneration in the biomarker-defined subpopulation. These imaging results are consistent with XPro™’s biological, cognitive, and neuropsychiatric signals in this population, and we expect to share details from additional imaging analyses in the near future. Importantly, these data support a precision-medicine development strategy in Alzheimer’s disease that aligns with emerging regulatory and payer expectations.

Financially, we exit 2025 well positioned for continued execution. In June we closed on a private placement, and we expect to receive a research and development rebate from Australia, bolstering our cash position. As of September 30, 2025, our cash and cash equivalents stood at approximately $27.7 million. These resources, combined with disciplined expense management, provide us with sufficient funds to last through year-end 2026, enabling us to achieve key milestones.

INmune Bio was founded on the belief that targeted immunomodulation can meaningfully change the course of devastating diseases. We remain at the forefront of biotechnology with two industry-leading assets: CORDStrom, a mesenchymal stromal cell platform engineered specifically for therapeutic use from inception, and XPro, a premier approach for treating complex neuroinflammatory conditions within the central nervous system.  While challenges remain, we are encouraged by the progress we have made and the opportunities ahead. We are committed to transparent communication, thoughtful decision-making, and the creation of long-term shareholder value.  Most importantly, our primary mission remains improving the lives of patients and their families.

On behalf of the entire INmune Bio team, thank you for your continued trust and support. We look forward to updating you on our progress throughout 2026.

Sincerely, 

David Moss
President & CEO 
INmune Bio, Inc.

References (numbered footnotes)
(1) Bageta M., et al. “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” (eClinicalMedicine Oct. 2025)
(2) INmune Bio, Inc. press release / GlobeNewswire: “INmune Bio Reports Key Findings from Phase 2 MINDFuL Trial of XPro™ in Early Alzheimer’s Disease” (June 30, 2025).
01-XX-2026 - INMB - 2026 Lette…
(3) van Dyck CH, et al. “Lecanemab in Early Alzheimer’s Disease” (CLARITY-AD). New England Journal of Medicine (published online/issue Jan 2023).
(4) Sims JR, et al. “Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial.” JAMA (2023).
(5) Estimated absolute effect sizes (approx. Cohen’s d) were calculated from the summary statistics for the model-estimated ADAS-Cog differences reported in (2) and (3).

About INmune Bio Inc.

INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. 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. The second 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. The third program, INKmune®, is designed to prime a patient’s natural killer cells to eliminate minimal residual disease in patients with cancer and is currently in a trial in metastatic castration-resistance prostate cancer.  To learn more, please visit www.inmunebio.com.

Forward Looking Statements

Clinical trials are in early stages 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 the results of the Phase 2 MINDFuL trial, the timing of key milestones, future plans or expectations for the treatment of XPro™, 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) 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 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

FAQ

What regulatory filings does INMB plan for CORDStrom in 2026?

The company plans a Marketing Authorization Application (MAA) mid‑summer 2026 to the UK MHRA and aims for a BLA in the U.S. toward end of 2026, subject to regulatory feedback.

How did XPro perform in the 2025 Phase 2 MINDFuL trial for INMB?

In a predefined biomarker‑positive early AD subgroup (n=100), XPro showed cognitive and biomarker signals including an EMACC effect size of 0.27 versus placebo.

What is INMB's reported cash position and runway as of Sept 30, 2025?

Cash and cash equivalents were approximately $27.7 million, and management expects funds plus rebates to support operations through year‑end 2026.

What manufacturing progress has INMB reported for CORDStrom (INMB)?

The company completed three commercial pilot‑scale runs at CGT Catapult in Stevenage, UK to prepare for regulatory filings.

Did INMB say the XPro Phase 2 results are sufficient for approval?

No; management said MINDFuL provides learning to refine patient selection and is engaging the FDA to define a registrational development path.