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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 4, 2025
INMUNE BIO INC.
(Exact name of registrant as specified in charter)
| Nevada | 001-38793 | 47-5205835 | ||
| (State or other jurisdiction | (Commission File Number) | (IRS Employer | ||
| of incorporation) | Identification No.) |
225 NE Mizner Blvd., Suite 640
Boca Raton, Florida 33432
(Address of Principal Executive Offices) (Zip Code)
(561) 710-0512
(Registrant’s Telephone Number, Including Area Code)
Not Applicable
(Former Name or Former Address, If Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Common Stock, par value $0.001 per share | INMB | The NASDAQ Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mart if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 7, 2025, INmune Bio Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2025, and provided a business update. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such filing.
Item 8.01. Other Events.
On August 4, 2025, the Company issued a press release announcing that that its Phase I/II trial (the “CaRe PC” trial) of INKmune™ for men with metastatic castration-resistant prostate cancer has met its primary and secondary endpoints and is now closed to further enrollment.
A copy of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial statements and Exhibits
(d) Exhibits.
| 99.1 | Press Release, dated August 7, 2025 | |
| 99.2 | Press Release, dated August 4, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| INMUNE BIO INC. | ||
| Date: August 7, 2025 | By: | /s/ David Moss |
| David Moss | ||
| Principal Executive Officer | ||
Exhibit 99.1
INmune Bio Inc. Announces Second Quarter 2025 Results, Provides Business Update and Announces Management Changes
BOCA RATON, Fla., Aug. 07, 2025 (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 June 30, 2025 and provides a business update.
Q2 2025 and Recent Corporate Highlights
DN-TNF Platform Highlights (XPro™):
| ● | Released top-line data from the MINDFuL phase 2 trial in 208 patients with MCI and early Alzheimer’s. |
| ● | The trial missed its primary cognitive endpoints in the 200 modified mITT patients enrolled, however; |
| ● | XPro demonstrated a positive impact on the primary cognitive endpoint EMACC in a pre-defined subset of 100 patients (50%) with two or more biomarkers of inflammation, defined as the enriched population. |
| ● | Additional data from the MINDFuL trial was presented by a Key Opinion Leader, Dr. Sharon Cohen of the Toronto Memory Program, at the Alzheimer’s Association International Conference (AAIC) on July 29th. This data is summarized in the forest plot below. |
Figure Legend: With the enriched population underpowered for detecting statistically significant changes, the Company and third-party statisticians relied on Cohen’s d effect sizes to evaluate the meaningfulness of observed changes. These effect sizes, though small, consistently favored XPro™ over placebo on the primary endpoint and multiple secondary and exploratory endpoints (see figure). Across most endpoints, XPro™ showed favorable trends, with effect sizes approaching the 0.2 threshold for clinical relevance.
The clinical endpoints shown in the forest plot include:
| ● | EMACC (Early Mild Alzheimer's Cognitive Composite)-Performance-based measure of Cognition: empirically derived composite of neuropsychological tests that are widely used in clinics. |
| ● | ISRL (International Shopping List Test, delayed recall) – Performance-based measure of Memory. Delayed recall component of widely used word-list learning test. |
| ● | CDR-SB (Clinical Dementia Rating Scale – Sum of Boxes) – Clinician-rated measure that combines Cognition and Function: interview with study partner and patient as well as some performance-based items completed by patient. |
| ● | NPI (Neuropsychiatric Interview) - Caregiver-reported measure of the patient's psychiatric symptoms. |
| ● | ECog (Everyday Cognition) - Caregiver reported questionnaire: caregiver rates the patient's change in cognition (skills now as compared to 10 years ago – prior to cognitive decline) |
| ● | GAS (Goal Attainment Scale) Personalized Patient and caregiver-rated scale where the specific goals and items are chosen by patient and caregiver and they rate change on the goals over the course of the study. |
| ● | Presented a poster at the Keystone Symposia that showed that XPro™ significantly reduces amyloid formation and improves clinical measures of brain function in patients with TBI (tTaumatic Brain Injury). |
CORDStrom Platform:
| ● | Received a favorable written opinion from The United States Patent and Trademark Office (USPTO), acting as the International Search Authority, on all claims in INmune Bio’s international patent application PCT/US25/17028, titled “THERAPEUTIC COMPOSITIONS COMPRISING POOLED, CULTURE-EXPANDED HUMAN UMBILICAL CORD DERIVED MESENCHYMAL STROMAL CELLS.” |
| ● | Partnered with the Cell and Gene Therapy Catapult (CGT Catapult) to establish large-scale, commercial-ready manufacturing for CORDStrom and the Company's other cell therapy platforms. This is an essential part of our ambitious timeline to transfer the manufacturing site, validate the large-scale manufacturing process and all of the analytical assays in time for MAA and BLA submissions next year. Much of this work continues to provide data to strengthen our existing IP position portfolio. |
| ● | The complete database of clinical data from the randomized, double-blind trial of CORDStrom in Recessive Dystrophic Epidermolysis Bullosa (RDEB) has now been delivered from the trial sponsor to an independent statistical analysis company which is applying a statistical analysis plan devised by INmuneBio. We believe this will enrich the data presented by the Sponsor previously and we anticipate the data being available in Q4. |
INKmune™ Platform:
| ● | Following success in meeting the primary endpoint at completion of the phase I aspect of the CARE-PC trial we opened the phase II in Q1 this year and quickly enrolled the first three patients. Early analysis of blood samples for the biomarkers of interest demonstrated that both secondary endpoints of NK activation and NK cell proliferation in vivo had been met. |
| ● | Determined that patients with low NK cell function responded better to treatment, with substantial increases in NK cell potency. This allows us to screen patients in future trials to direct treatment only to those with the ability to respond, in the same way that patients have been screened for suitability for treatment with checkpoint inhibitor drugs. |
| ● | We await receipt of results of PSMA-PET scans for most of the trial subjects, although initial results from the phase I patients showed reduction or control of individual lesions in a background of worsening disease. |
| ● | Having reviewed the current data, we concluded that the CARE-PC trial has provided all the data needed to design a future randomized trial and we have closed the trial to further recruitment to ensure completion of follow-up by end of Q4 of 2025 as planned. |
Corporate:
| ● | Dr. RJ Tesi retires as CEO. |
| ● | David Moss appointed President & CEO and to the Board of Directors. |
| ● | Cory Ellspermann appointed as Interim CFO. |
| ● | Kelly Ganjei appointed as Chairman of the Board. |
| ● | Closed a $19 million registered direct offering. |
Upcoming Events and Milestones:
| ● | End of phase 2 meeting regarding the MINDFuL trial with the FDA expected to take place in the fourth quarter. |
| ● | The Company will file a publication on the MINDFuL trial results expected to be available this month. |
| ● | The Company remains on track to file a Marketing Authorization Application (MAA) in the UK and Biologic License Application (BLA) for CORDStrom in RDEB by mid-2026. |
| ● | We have ambitious plans to develop a pipeline of additional indications for CORDStrom which we will pursue with non-dilutive funding or partnerships. |
| ● | Additional data from Greater Orman Street Hospital on RDEB patients treated with CORDStrom expected in the fourth quarter. |
| ● | More patient data from the INKmune™ ongoing phase 2 trial in metastatic castration-resistant prostate cancer will be released as it becomes available. |
Financial Results for the Second Quarter Ended June 30, 2025:
| ● | Net loss attributable to common stockholders for the quarter ended June 30, 2025 was approximately $24.5 million, compared to approximately $9.7 million during the quarter ended June 30, 2024. |
| ● | Research and development expenses totaled approximately $5.9 million for the quarter ended June 30, 2025, compared to approximately $7.1 million during the quarter ended June 30, 2024. |
| ● | General and administrative expenses were approximately $2.3 million for the quarter ended June 30, 2025, compared to approximately $2.8 million during the quarter ended June 30, 2024. |
| ● | Impairment of acquired in-process research and development intangible assets was $16.5 million during the quarter ended June 30, 2025 compared to none recorded during the quarter ended June 30, 2024. |
| ● | Other income, net was approximately $0.1 million for the quarter ended June 30, 2025, compared to approximately $0.1 million during the quarter ended June 30, 2024. |
| ● | As of June 30, 2025, the Company had cash and cash equivalents of approximately $33.4 million. |
| ● | As of August 7, 2025, 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: August 7th, 2025
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-225-9448 Participant Dial-in (international): +1-203-518-9783
Conference ID: INMUNE
A live audio webcast of the call can be accessed by clicking here or using this link:
https://viavid.webcasts.com/starthere.jsp?ei=1719932&tp_key=2300519883
A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 21, 2025 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering pin no. 11159128.
About XPro™
XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.
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 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 at low cost and with repeatable specification independent of donor characteristics. The CORDStrom™ product platform shares many similarities, including reagents, equipment, and procedures, with the Company’s INKmune® oncology product, enabling the Company to leverage economies of scale, experienced staff, and other resources to strategically manufacture both products in a rotational campaign with resource and environmental efficiencies.
Initially developed at the INKmune® manufacturing facilities utilizing UK academic grant funding, CORDStrom™ is an MSC product platform that shows promise as a first systemic therapy for potentially treating RDEB and many other debilitating conditions. 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 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: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical development to determine if they can treat Alzheimer’s disease and other indications (XPro™). The Natural Killer Cell Priming Platform includes INKmune® developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer and is currently in trials in metastatic castration-resistance prostate cancer. The third program, CORDStrom™, is a proprietary allogeneic, pooled, human umbilical cord-derived mesenchymal Stromal cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa. INmune Bio’s product platforms utilize a precision medicine approach for diseases driven by chronic inflammation and cancer.
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 through 2026 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.
Company Contact:
David Moss
Chief Executive Officer
(561) 710-0512
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)
| June 30, 2025 |
December 31, 2024 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 33,374 | $ | 20,922 | ||||
| Research and development tax credit receivable | 1,605 | 1,181 | ||||||
| Other tax receivable | 550 | 228 | ||||||
| Prepaid expenses and other current assets | 231 | 331 | ||||||
| TOTAL CURRENT ASSETS | 35,760 | 22,662 | ||||||
| Equipment | 706 | - | ||||||
| Operating lease – right of use asset | 1,109 | 307 | ||||||
| Other assets | 570 | 79 | ||||||
| Acquired in-process research and development intangible assets | - | 16,514 | ||||||
| TOTAL ASSETS | $ | 38,145 | $ | 39,562 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 7,453 | $ | 6,539 | ||||
| Accounts payable and accrued liabilities – related parties | 184 | 25 | ||||||
| Deferred liabilities | 511 | 517 | ||||||
| Operating lease, current liabilities | 535 | 140 | ||||||
| TOTAL CURRENT LIABILITIES | 8,683 | 7,221 | ||||||
| Long-term operating lease liabilities | 683 | 244 | ||||||
| TOTAL LIABILITIES | 9,366 | 7,465 | ||||||
| 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 and 22,280,451 shares issued and outstanding, respectively | 27 | 22 | ||||||
| Additional paid-in capital | 226,904 | 195,754 | ||||||
| Accumulated other comprehensive loss | (774 | ) | (575 | ) | ||||
| Accumulated deficit | (197,378 | ) | (163,104 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 28,779 | 32,097 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 38,145 | $ | 39,562 | ||||
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 June 30, |
For the Six Months Ended June 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| REVENUE | $ | - | $ | - | $ | 50 | $ | 14 | ||||||||
| OPERATING EXPENSES | ||||||||||||||||
| General and administrative | 2,253 | 2,812 | 4,569 | 5,150 | ||||||||||||
| Research and development | 5,881 | 7,053 | 13,520 | 15,746 | ||||||||||||
| Impairment of acquired in-process research and development intangible assets | 16,514 | - | 16,514 | - | ||||||||||||
| Total operating expenses | 24,648 | 9,865 | 34,603 | 20,896 | ||||||||||||
| LOSS FROM OPERATIONS | (24,648 | ) | (9,865 | ) | (34,553 | ) | (20,882 | ) | ||||||||
| OTHER INCOME, NET | 113 | 119 | 279 | 111 | ||||||||||||
| NET LOSS | $ | (24,535 | ) | $ | (9,746 | ) | $ | (34,274 | ) | $ | (20,771 | ) | ||||
| Net loss per common share – basic and diluted | $ | (1.05 | ) | $ | (0.50 | ) | $ | (1.50 | ) | $ | (1.11 | ) | ||||
| Weighted average common shares outstanding – basic and diluted | 23,298,455 | 19,307,323 | 22,899,539 | 18,666,898 | ||||||||||||
| COMPREHENSIVE LOSS | ||||||||||||||||
| Net loss | $ | (24,535 | ) | $ | (9,746 | ) | $ | (34,274 | ) | $ | (20,771 | ) | ||||
| Other comprehensive income (loss) – foreign currency translation | (164 | ) | (44 | ) | (199 | ) | 86 | |||||||||
| Total comprehensive loss | $ | (24,699 | ) | $ | (9,790 | ) | $ | (34,473 | ) | $ | (20,685 | ) | ||||
INMUNE BIO INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
| For the Six Months Ended June 30, |
||||||||
| 2025 | 2024 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (34,274 | ) | $ | (20,771 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 3,610 | 4,129 | ||||||
| Accretion of debt discount | - | 58 | ||||||
| Impairment of acquired in-process research and development intangible assets | 16,514 | - | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | (424 | ) | (1,238 | ) | ||||
| Other tax receivable | (322 | ) | 267 | |||||
| Prepaid expenses | 100 | 497 | ||||||
| Prepaid expenses – related party | - | 142 | ||||||
| Other assets | (491 | ) | 50 | |||||
| Accounts payable and accrued liabilities | 914 | 1,381 | ||||||
| Accounts payable and accrued liabilities – related parties | 159 | 104 | ||||||
| Deferred liabilities | (6 | ) | 32 | |||||
| Operating lease liabilities | 32 | (13 | ) | |||||
| Net cash used in operating activities | (14,188 | ) | (15,362 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Purchase of equipment | (706 | ) | - | |||||
| Net cash used in investing activities | (706 | ) | - | |||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from sale of common stock and warrants | 27,544 | 15,497 | ||||||
| Exercise of warrants for cash | 1 | - | ||||||
| Repayments of debt | - | (5,000 | ) | |||||
| Net cash provided by financing activities | 27,545 | 10,497 | ||||||
| Impact on cash from foreign currency translation | (199 | ) | 86 | |||||
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 12,452 | (4,779 | ) | |||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 20,922 | 35,848 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 33,374 | $ | 31,069 | ||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||||||
| Cash paid for income taxes | $ | - | $ | - | ||||
| Cash paid for interest expense | $ | - | $ | 523 | ||||
8
Exhibit 99.2
INmune Bio’s CaRe PC Trial of INKmune™ in Metastatic Castration-Resistant Prostate Cancer Meets Endpoints and Is Closed to Enrollment
BOCA RATON, FL, Aug. 04, 2025 (GLOBE NEWSWIRE) - INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology and inflammation company, is pleased to report that its Phase I/II trial (the “CaRe PC” trial) of INKmune™ for men with metastatic castration-resistant prostate cancer (mCRPC) has met its primary and secondary endpoints and is now closed to further enrollment.
INKmune™ was well tolerated at all three dose levels in the trial, demonstrating an excellent safety profile, the primary endpoint of CaRe PC. Additionally, patients with low NK cell activation saw the greatest improvement in their biomarkers of NK cell activation, defining the target population for the next trials.
“INKmune was safe and effective at activating NK cells in a subset of more than half of these patients with advanced disease,” stated Dr. Mark Lowdell, CSO at INmune Bio. “Excitingly we did see, in some patients, individual tumor lesions either reducing in size or completely disappearing during treatment, so we believe this could be evidence of a direct effect on tumor cell killing.”
Following the successful completion of the Phase 1/2 trial of INKmune™ in patients with advanced-stage disease, INmune Bio plans to advance the program by designing a randomized Phase 2b trial in patients with less severe disease, enabling a more robust measurement of the drug’s effects and potential clinical benefits.
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: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat Mild Alzheimer’s disease, Mild Cognitive Impairment and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune® developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer and is currently in a trial in metastatic castration-resistance prostate cancer. The third program, CORDStrom™, is a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa. INmune Bio’s product platforms utilize a precision medicine approach for diseases driven by chronic inflammation and 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 Contact:
David Moss
Co-founder and Chief Financial Officer
(858) 964-3720
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com