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INmune Bio Inc. Announces First Quarter 2026 Results and Provides Business Update

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INmune Bio (NASDAQ: INMB) reported Q1 2026 results and operational milestones on May 7, 2026. Key highlights: net loss $5.4M, R&D $3.6M, G&A $2.2M, and ~26.6M shares outstanding as of May 7, 2026.

Clinical progress: CORDStrom MAA to the UK MHRA mid-summer, follow-on EMA and planned FDA BLA in Q4 2026; XPro advanced to adaptive Phase 2b/3 for early Alzheimer’s; ongoing imaging analyses and preclinical INB03 data reported.

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Positive

  • Net loss narrowed to $5.4M in Q1 2026
  • CORDStrom MAA filing targeted UK mid-summer 2026
  • FDA alignment to adaptive Phase 2b/3 for XPro in early AD

Negative

  • R&D spend fell to $3.6M, possibly reflecting program timing
  • FDA BLA for CORDStrom not expected until Q4 2026

Market Context

This announcement combines a materially lower quarterly net loss of $5.4M, reduced R&D expenses of $...
Analysis

This announcement combines a materially lower quarterly net loss of $5.4M, reduced R&D expenses of $3.6M, and detailed timelines for CORDStrom’s planned UK MAA and FDA BLA submissions, alongside continued work on XPro in early Alzheimer’s disease. Historically, earnings updates that pair financial data with clear clinical and regulatory steps have shaped sentiment. Investors may focus on expense trends, upcoming 2026 filing milestones, and progress in imaging and registrational plans as key markers for execution quality.

Key Figures

Net loss: $5.4M R&D expenses: $3.6M G&A expenses: $2.2M +5 more
8 metrics
Net loss $5.4M Quarter ended March 31, 2026; vs ~$9.7M in Q1 2025
R&D expenses $3.6M Quarter ended March 31, 2026; vs ~$7.6M in Q1 2025
G&A expenses $2.2M Quarter ended March 31, 2026; vs ~$2.3M in Q1 2025
Shares outstanding 26.6M Common shares outstanding as of May 7, 2026
CORDStrom MAA timing Mid-summer 2026 Planned UK MHRA Marketing Authorization Application submission
CORDStrom BLA timing Q4 2026 Expected FDA Biologics License Application submission
MissionEB trial phase Phase III CORDStrom systemic disease-modifying data in RDEB
MINDFuL phase Phase 2 XPro imaging and clinical data in early Alzheimer’s disease

Previous Earnings Reports

4 past events · Latest: Oct 30 (Positive)
Same Type Pattern 4 events
Date Event Sentiment 24h Move Catalyst
Oct 30 Q3 2025 earnings Positive +5.8% Reported reduced net loss and highlighted CORDStrom and XPro clinical progress.
Oct 31 Q3 2024 earnings Positive +3.3% Detailed Alzheimer’s trial progress, INKmune data, and capital raises with solid cash.
Aug 01 Q2 2024 earnings Positive +3.3% Outlined XPro enrollment progress, INKmune advances, and additional equity capital.
May 09 Q1 2024 earnings Positive -7.0% Shared platform milestones and funding, but stock sold off despite the update.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings and business updates have usually been followed by modest positive moves, with one notable negative reaction despite seemingly constructive operational progress.

Recent Company History

Over the past few years, INmune Bio’s earnings updates have consistently paired financial results with pipeline milestones across CORDStrom, XPro and INKmune. Prior reports highlighted reduced net losses, cash balances above $27M, and steady advancement of CORDStrom toward an MAA and XPro toward late-stage Alzheimer’s studies. Market reactions to these earnings pieces were mostly positive single‑digit moves, suggesting investors have historically rewarded clear clinical and regulatory progress communicated alongside financial results.

Key Terms

marketing authorization application (maa), biologics license application (bla), mesenchymal stromal cell (msc), phase iii, +4 more
8 terms
marketing authorization application (maa) regulatory
"The Marketing Authorization Application (MAA) for CORDStrom™ is scheduled for submission"
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
"CORDStrom™ Biologics License Application (BLA) submission to the FDA expected in Q4 2026."
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.
mesenchymal stromal cell (msc) medical
"future applications and research areas for mesenchymal stromal cell (MSC) therapies"
Mesenchymal stromal cells (MSCs) are versatile, adult-derived cells found in bone marrow, fat and other tissues that can help repair damaged tissue and calm excessive immune reactions; think of them as a handyman and emergency crew that can both patch structural damage and coordinate healing. They matter to investors because companies developing MSC-based therapies face scientific, manufacturing and regulatory hurdles but also the potential for sizable markets in regenerative medicine and immune-related diseases.
phase iii medical
"MissionEB Phase III clinical trial highlighting the systemic disease-modifying capabilities"
A Phase III trial is the late-stage clinical study that tests whether a medical treatment works and is safe in a large group of patients, often comparing it to standard care. Think of it as a final dress rehearsal or full-scale road test before regulators decide on approval; positive or negative results strongly influence a drug maker’s chance to sell the treatment, future revenue, and investment risk.
phase 2b/3 medical
"advance to an adaptive Phase 2b/3 registrational pathway with XPro™ in early Alzheimer's"
A phase 2b/3 trial is a combined late-stage clinical study that first refines the best dose and measures how well a treatment works (phase 2b) then expands to a larger, definitive test of safety and effectiveness needed for regulatory approval (phase 3). For investors, results from a phase 2b/3 act like a dress rehearsal that turns into opening night: positive, well-controlled outcomes substantially raise the chance of approval and future sales, while failures can sharply reduce a drug’s value.
recessive dystrophic epidermolysis bullosa (rdeb) medical
"CORDStrom™ program in recessive dystrophic epidermolysis bullosa (RDEB) is on target"
A rare inherited skin disorder in which the body’s outer layer peels or blisters from minor friction, leaving chronic wounds and a high risk of infection; the “recessive” part means a child must inherit a faulty gene from both parents. For investors, rDEB represents a clear unmet medical need and a defined patient population, making successful therapies potentially valuable—like fixing a persistent structural problem in a building that everyone depends on.
her2-positive medical
"INB03 (XPro1595) Overcomes Resistance and Reduces Metastases in HER2-Positive Breast Cancer"
HER2-positive describes cancer cells that have too many copies of the HER2 gene or make too much of the HER2 protein, which acts like an overactive growth switch that drives tumor growth. For investors, HER2 status matters because it determines whether patients can receive specific, often expensive targeted therapies and diagnostic tests, so trial results, approvals, or competing drugs tied to HER2 can strongly affect drug sales and company value.
metastases medical
"INB03 (XPro1595) Overcomes Resistance and Reduces Metastases in HER2-Positive"
Metastases are secondary tumors that form when cancer cells break away from the original tumor and establish new growths in other organs or tissues, like seeds scattering from a plant and taking root elsewhere. For investors, metastases matter because they usually make a disease harder and more expensive to treat, influence patient outcomes and survival, and can affect the size and urgency of the market for therapies, clinical trial design, regulatory review, and reimbursement decisions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Company to Host Conference Call Today, May 7th, at 4:30pm ET

BOCA RATON, Fla., May 07, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces its financial results for the quarter ended March 31, 2026 and provides a business update.

Q1 2026 Recent Highlights:

CORDStrom™ Platform:

  • Completed a pre-submission package with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). The CORDStrom™ program in recessive dystrophic epidermolysis bullosa (RDEB) is on target to file an MAA submission in the UK mid-summer, followed shortly thereafter by anticipated EMA and FDA regulatory submissions.
  • Signed an amended and restated Material Transfer and License Agreement with Anthony Nolan. This expanded strategic collaboration secures the long-term, reliable supply of high-quality umbilical cord tissue from their world-class cord blood bank to fuel our CORDStrom™ platform.
  • Hosted KOL led webinar focused on the latest results from the MissionEB Phase III clinical trial highlighting the systemic disease-modifying capabilities of CORDStrom™ in patients with RDEB.
  • Announced the publishing of an overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies in the peer-reviewed journal Cytotherapy.

DN-TNF Platform:

XPro™:

  • Reported new Phase 2 imaging data at the 18th Clinical Trials on Alzheimer's Disease conference (CTAD), in San Diego, CA. Additional brain imaging analyses are ongoing and expected to be reported in the near future.
  • Announced FDA alignment to advance to an adaptive Phase 2b/3 registrational pathway with XPro™ in early Alzheimer's Disease.
  • Hosted expert-led webinar on XPro™ registrational study strategy for early Alzheimer's Disease, with the discussion focused on results of the Phase 2 MINDFuL trial and alignment with the FDA following the End-of-Phase 2 meeting.
  • INmune’s MINDFuL trial was featured in a plenary presentation at the AD/PD 2026 conference as a successful example of how aligning patient selection with mechanism of action identifies the patients most likely to respond.

INB03:

  • Announced New Preclinical Data at AACR 2026 Demonstrating INB03 (XPro1595) Overcomes Resistance and Reduces Metastases in HER2-Positive Breast Cancer Models.
  • Ongoing analysis of immune activation and tumor response endpoints to inform future development strategy.

Upcoming Events and Milestones:

  • The Marketing Authorization Application (MAA) for CORDStrom™ is scheduled for submission to the UK’s MHRA in mid-summer, followed directly by an EMA filing.
  • CORDStrom™ Biologics License Application (BLA) submission to the FDA expected in Q4 2026.
  • Additional imaging analyses from the MINDFuL trial with XPro™ in early Alzheimer's Disease is expected to be reported in the near future.

Financial Results for the First Quarter Ended March 31, 2026:

  • Net loss attributable to common stockholders for the quarter ended March 31, 2026 was approximately $5.4 million, compared to approximately $9.7 million during the quarter ended March 31, 2025.
  • Research and development expenses totaled approximately $3.6 million for the quarter ended March 31, 2026, compared to approximately $7.6 million during the quarter ended March 31, 2025.
  • General and administrative expenses were approximately $2.2 million for the quarter ended March 31, 2026, compared to approximately $2.3 million during the quarter ended March 31, 2025.
  • As of May 7, 2026, the Company had approximately 26.6 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio First Quarter Conference Call when reaching the operator.

Date: May 7th, 2026

Time: 4:30 PM Eastern Time

Participant Dial-in: 1-800- 1-800-717-1738 or (international): +1-646-307-1865

Conference ID: INMUNE

An audio webcast of the call can be accessed by clicking here or using this link:

https://viavid.webcasts.com/starthere.jsp?ei=1761180&tp_key=01afd3034a

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through May 21st, 2026 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering pin no. 1143455.

About CORDStrom™

CORDStrom™ is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom™ platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory and autoimmune diseases. 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. Pooling allows tuning of different CORDStrom products with different effector functions dependent upon selected donor characteristics. While the first generation CORDStrom™ product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.

About XPro™

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 our website at www.inmunebio.com.

About INKmune™

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 upregulated 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 this year.

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: (1) CORDStrom™, 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; (2) XPro™, a Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform designed to selectively neutralize soluble TNF, a key driver of inflammation and innate immune dysfunction; and (3) INKmune®, a cell-based medicine designed to prime a patient’s natural killer cells to eliminate minimal residual disease in patients with 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 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.

David Moss
Co-founder and Chief Executive Officer
(858) 964-3720
info@inmunebio.com

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

The following tables summarize our results of operations for the periods indicated:

 
INMUNE BIO INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
       
  March 31,
2026
  December 31,
2025
 
ASSETS      
CURRENT ASSETS      
Cash and cash equivalents $21,358  $24,751 
Research and development tax credit receivable  479   4,284 
Other tax receivable  291   257 
Prepaid expenses and other current assets  694   595 
TOTAL CURRENT ASSETS  22,822   29,887 
         
Equipment, net  903   955 
Operating lease – right of use asset  1,410   914 
Other assets  683   595 
         
TOTAL ASSETS $25,818  $32,351 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
CURRENT LIABILITIES        
Accounts payable and accrued liabilities $4,659  $7,768 
Accounts payable and accrued liabilities – related parties  25   25 
Operating lease, current liabilities  704   623 
TOTAL CURRENT LIABILITIES  5,388   8,416 
         
Long-term operating lease liability  806   411 
TOTAL LIABILITIES  6,194   8,827 
         
COMMITMENTS AND CONTINGENCIES        
         
STOCKHOLDERS’ EQUITY        
Preferred stock, $0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding  -   - 
Common stock, $0.001 par value, 200,000,000 shares authorized, 26,585,258 shares issued and outstanding  27   27 
Additional paid-in capital  234,768   233,271 
Accumulated other comprehensive loss  (727)  (737)
Accumulated deficit  (214,444)  (209,037)
TOTAL STOCKHOLDERS’ EQUITY  19,624   23,524 
         
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $25,818  $32,351 
         


 
INMUNE BIO INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)
(Unaudited)
    
  For the Three Months Ended
March 31,
 
  2026  2025 
REVENUE $-  $50 
         
OPERATING EXPENSES        
General and administrative  2,171   2,316 
Research and development  3,641   7,639 
Total operating expenses  5,812   9,955 
         
LOSS FROM OPERATIONS  (5,812)  (9,905)
         
OTHER INCOME, NET  405   166 
         
NET LOSS $(5,407) $(9,739)
         
Net loss per common share – basic and diluted $(0.20) $(0.43)
         
Weighted average common shares outstanding – basic and diluted  26,585,258   22,496,191 
         
COMPREHENSIVE LOSS        
Net loss $(5,407) $(9,739)
Other comprehensive income (loss) – foreign currency translation  10   (35)
Total comprehensive loss $(5,397) $(9,774)
         


 
INMUNE BIO INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
    
  For the Three Months Ended
March 31,
 
  2026  2025 
CASH FLOWS FROM OPERATING ACTIVITIES:      
Net loss $(5,407) $(9,739)
Adjustments to reconcile net loss to net cash used in operating activities:        
Stock-based compensation  1,497   2,076 
Gain on settlement of accounts payable  (91)  - 
Depreciation expense  52   - 
Changes in operating assets and liabilities:        
Research and development tax credit receivable  3,805   (102)
Other tax receivable  (34)  95 
Prepaid expenses  (99)  124 
Other assets  (88)  30 
Accounts payable and accrued liabilities  (3,018)  659 
Accounts payable and accrued liabilities – related parties  -   78 
Deferred liabilities  -   (37)
Operating lease liabilities  (20)  (8)
Net cash used in operating activities  (3,403)  (6,824)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Sale of common stock for cash  -   5,273 
Exercise of warrants for cash  -   1 
Net cash provided by financing activities  -   5,274 
         
Impact on cash from foreign currency translation  10   (35)
         
NET DECREASE IN CASH AND CASH EQUIVALENTS  (3,393)  (1,585)
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD  24,751   20,922 
CASH AND CASH EQUIVALENTS AT END OF PERIOD $21,358  $19,337 
         
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION:        
Cash paid for income taxes $-  $- 
Cash paid for interest expense $-  $- 
         
SUPPLEMENTAL NONCASH INVESTING AND FINANCING ACTIVITIES        
Right of use assets obtained in exchange for lease obligations $587  $- 
         



FAQ

What were INmune Bio (INMB) Q1 2026 financial results reported on May 7, 2026?

INmune Bio reported a net loss of approximately $5.4M for Q1 2026. According to the company, R&D expenses were about $3.6M and G&A about $2.2M, with roughly 26.6 million common shares outstanding as of May 7, 2026.

When will INmune Bio (INMB) submit the CORDStrom MAA to the UK MHRA?

The company expects to submit the CORDStrom MAA to the UK MHRA in mid-summer 2026. According to the company, an EMA filing will follow directly and a planned FDA BLA submission is expected in Q4 2026.

What regulatory pathway did INmune Bio (INMB) receive for XPro in early Alzheimer’s disease?

INmune Bio reported FDA alignment to advance XPro to an adaptive Phase 2b/3 registrational pathway. According to the company, this follows an End-of-Phase 2 meeting and Phase 2 imaging results presented at CTAD.

What clinical and preclinical updates did INmune Bio (INMB) announce on May 7, 2026?

The company highlighted CORDStrom Phase III results and upcoming MAA/EMA/FDA filings, Phase 2 imaging data for XPro, and preclinical INB03 data showing reduced metastases. According to the company, additional imaging analyses and immune response data are ongoing.

How many INmune Bio (INMB) shares were outstanding as of May 7, 2026?

As of May 7, 2026, INmune Bio had approximately 26.6 million common shares outstanding. According to the company, this figure reflects shares outstanding reported in the Q1 2026 business update.