INmune Bio Inc. Announces Year End 2024 Results and Provides a Business Update
Company to Host Conference Call Today, March 27, at 4:30pm ET
BOCA RATON, Fla., March 27, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient's innate immune system to fight disease, today announces its financial results for the year ended December 31, 2024 and provides a business update.
Full Year 2024 and Recent Corporate Highlights
DN-TNF Platform Highlights (XPro1595, XPro$(TM)$):
-- Announced completion of enrollment for its Phase 2 trial on Friday, 27
September, 2024. This global, blinded, randomized Phase 2 trial (the
"AD02 trial") is focused on patients with Early Alzheimer's Disease (AD)
and biomarkers of elevated neuroinflammation. Final enrollment of 208
patients exceeded the trial's target enrollment of 201 patients.
-- Completed two separate interim analyses of blinded data from its AD02
trial. The analyses demonstrated exceptional performance of the novel
cognitive measure EMACC, as well as highly significant correlation
between baseline EMACC and Clinical Dementia Rating-Sum of Boxes
(CDR-SB). Key findings of the analysis included:
-- Statistical Correlation: An independent review confirmed a
significant correlation (p<0.001) between baseline scores on EMACC
and CDR-SB, the key cognitive endpoints in the AD02 trial.
-- Reliability: The correlation of EMACC when measured during the
screening process and again at the first study visit before
treatment was found to be 0.93. Higher precision produces results
that are more robust and replicable with smaller sample sizes.
-- Differentiation Capability: The difference in EMACC performance
between patients with CDR global ratings of 0.5 (prodromal AD) and
those rated 1.0 (mild dementia) was very large, with an effect
size (Cohen's d) of 0.87 (p<.0001). This demonstrates EMACC's
ability to accurately differentiate between disease stages,
highlighting its sensitivity and precision.
-- Hosted a webinar titled "Why EMACC is the Optimal Tool for Measuring
Cognitive Change in Early Alzheimer's Trials," that explained the
development of EMACC and its advantages in assessing cognitive changes
over time in early AD patients while also covering the regulatory
landscape for Alzheimer's disease drug development and the role of the
CDR-SB clinical scale. The replay can be found here or with this
link: https://www.youtube.com/watch?v=3-J3nx_uxMc.
-- Announced publication in Cell Reports, "Microglia Regulate Cortical
Remyelination via NFR1-Dependent Phenotypic Polarization." Myelin is
necessary for fast and efficient communication between neurons. Loss of
myelin compromises neuron function and communication and is a key step in
the neurodegenerative process of many CNS diseases, including Alzheimer's
Disease. Data from the publication identifies soluble TNF as a critical
cytokine checkpoint that converts microglia from a reparative,
remyelinating cell to a damaging, demyelinating cell. These data suggest
that blocking soluble TNF is a promising strategy for treating
demyelinating diseases.
-- Announced new phase 1 study data presented at the annual Alzheimer's
Association International Conference on 29 July 2024 demonstrating
dose-dependent effect of XPro(TM) on Proteins that regulate synapses in
Alzheimer's patients. The new analysis revealed that a 12-week treatment
with XPro(TM) resulted in a significant change in synaptic proteins,
which are essential for communication between neurons.
-- Announced statistically significant improvements in
electroencephalography $(EEG.AU)$, a biomarker of brain function, in patients
with moderate to severe Alzheimer's Disease treated with XPro(TM) for
four weeks.
-- Demonstrated 24-month stability validation of XPro(TM) for phase III
readiness and commercial supply chain modeling & announced development of
novel immunogenicity assay.
CORDStrom(TM) Platform
-- Reported results of a double-blinded, randomized, placebo-controlled,
cross-over study, known as "MissionEB," investigating CORDStrom(TM) for
treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) in
pediatric patients, which evidenced a favorable benefit-risk profile.
-- FDA granted CORDStrom(TM) a Rare Pediatric Disease Designation (RPDD) and
Orphan Drug Designation $(ODD)$ for treatment of epidermolysis bullosa
$(EB)$.
-- Data from the MissionEB trial show that CORDStrom(TM) was easily
delivered, extremely well tolerated, with no serious adverse events
related to CORDStrom(TM) reported at either 3-months or 6-months
post-treatment across all age and RDEB-severity patient sub-types. In
children with severe disease, CORDStrom(TM) reduced itch at 3-months and
led to a sustained reduction of over 27% at 6-months in some patients.
These results demonstrate that a clinically meaningful reduction in itch
severity is sustained over time. In children with intermediate disease
severity, CORDStrom(TM) provided a broader range of improvements,
including reduced skin involvement and less pain, as well as a large
reduction in itch. In younger children with RDEB (age <10yrs),
CORDStrom(TM) provided improvements in skin scores, indicating better
skin integrity and reduced disease activity. Interviews with subjects and
caregivers strongly support the clinical benefits of CORDStrom(TM) as
both caregivers and patients were able to correctly identify which
treatment had been CORDStrom(TM) and which had been placebo in this
cross-over study.
-- The Company plans to initiate a 12-month open label study at GOSH,
including all patients enrolled in the MissionEB study, where patients
will receive 3 cycles of CORDStrom(TM) therapy at 0, 4 and 8 months. Each
cycle of CORDStrom(TM) is a single infusion of CORDStrom(TM) 14 days
apart.
INKmune$(R)$ Platform:
-- Announced that INKmune(R) demonstrates excellent safety and increased
NK-Cell activity in the first dosing cohort, in its Phase I/II trial (the
"CaRe PC" trial) for men with metastatic Castration-Resistant Prostate
Cancer (mCRPC). Blinded analysis of the monitoring blood samples from the
first three patients showed changes in the phenotype and function of the
patient's NK cells. Although this is the lowest dose cohort, 2 of 3
patients showed an increase in circulating activated NK cells and all
three showed increased NK cell function sustained for more than 40 days
after the final INKmune(R) infusion.
-- The CaRe PC trial completed dosing of all patients in the phase I part of
the trial and commenced dosing phase II patients at the intermediate and
high dose cohorts. Interim analysis of the first three patients treated
at the lowest dose was presented at the Innate Killer Summit conference
in San Diego earlier this month and reported changes in all biomarkers
consistent with NK cell activation in vivo post INKmune(R) treatment
which mirrored that seen in patients with AML/MDS treated previously.
-- Published landmark paper in Journal Immunotherapy of Cancer
senior-authored by Mark Lowdell, PhD, Chief Scientific Officer, titled,
"Proteomic and phenotypic characteristics of memory-like Natural Killer
cells for cancer immunotherapy." The study demonstrates that memory-like
natural killer (mlNK) cells, generated by either cytokine or INKmune(R)
priming, show increased cytotoxicity against multiple tumor types,
offering promising potential for cancer immunotherapy. Importantly, while
most studies are conducted on NK cells from healthy volunteers, this
study demonstrated that mlNK from cancer patients are equally as potent
as those generated from healthy volunteers further supporting INKmune's
in vivo treatment methodology. The research also provides new insights
into the metabolic and physiological mechanisms underlying NK cell memory,
paving the way for innovative treatments in both hematological
malignancies and solid tumors.
-- Announced new format of INKmune(R) that supports highest trial dose with
single bag administration and expansion of bioreactor capacity in
preparation of scalable manufacturing. An IND amendment with the improved
formulation has been submitted to the FDA that also includes additional
validation data supporting an alternative critical reagent used in
INKmune(R) manufacturing, improving supply chain redundancy.
-- Safety of INKmune(R) remains excellent. There have been more than 30
administrations of INKmune(R) in the mCRPC study given on an out-patient
basis, with no significant drug related adverse events or episodes of
cytokine release syndrome $(CRS)$. Combining the experience with INKmune(R)
from the MDS/AML and mCRPC trials, over 40 infusions of INKmune(R) have
been given safely without the need for conditioning therapy,
pre-medication, or cytokine support.
Corporate:
-- Completed repayment of outstanding Silicon Valley Bank term loan in
December.
-- Executed securities purchase agreements with new and existing
institutional investors and certain directors, officers and employees of
the Company for total gross proceeds of approximately $27.5 million. As
part of the offerings, the company issued approximately 3.9 million
warrants to purchase common stock. The term of the warrants may be
accelerated with positive AD02 data as defined in the warrant agreements,
which if exercised for cash will raise approximately $30 million dollars.
-- Sold shares of common stock through the ATM program during 2024 for total
gross proceeds of approximately $2.4 million. Between January 1, 2025,
and March 27, 2025, sold shares of common stock through the ATM program
for total gross proceeds of approximately $5.4 million.
-- Joined the broad-market Russell 3000(R) Index at the conclusion of the
2024 Russell US Indexes annual reconstitution, effective as of July 1,
2024.
-- Received a research and development rebate from Australia in July of
approximately $2.5 million USD.
Upcoming Events and Milestones:
-- Top line cognitive results and secondary endpoints from the AD02 trial in
Alzheimer's Disease will be available in June 2025.
-- Data from the ongoing INKmune(R) trial in mCRPC will be released as they
become available. The next data set should be released in Q2 or Q3, 2025.
-- A Phase II trial of XPro(TM) in patients with Treatment-Resistant
Depression will begin enrollment soon once the NIH releases funds for the
trial.
-- Anticipate filing a BLA in RDEB in 2025 or early 2026 followed by MAA
application in the UK and EU. If approved on or prior to September 2026,
CORDstrom(TM) could be eligible for a Priority Review Voucher.
Financial Results for the Year Ended December 31, 2024:
-- Net loss attributable to common stockholders for the year ended December
31, 2024 was approximately $42.1 million, compared to approximately $30.0
million during the year ended December 31, 2023.
-- Research and development expenses totaled approximately $33.2 million for
the year ended December 31, 2024, compared to approximately $20.3 million
during the year ended December 31, 2023.
-- General and administrative expenses were approximately $9.5 million for
the year ended December 31, 2024, compared to approximately $9.6 million
during the year ended December 31, 2023.
-- Other income, net, was approximately $0.6 million for the year ended
December 31, 2024, compared to other expense, net, of approximately $0.3
million during the year ended December 31, 2023.
-- As of December 31, 2024, the Company had cash and cash equivalents of
approximately $20.9 million.
-- As of March 27, 2025, the Company had approximately 22.9 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 2024 Year End Conference Call when reaching an operator.
Date: March 27, 2025
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-225-9448 or 1-203-518-9708 (international): 1-203-518-9808
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=1704589&tp_key=4727e947f4
A transcript will follow approximately 24 hours from the scheduled call. A telephone replay will also be available for approximately 30 days by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11157984.
About XPro(TM)
XPro(TM) 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(TM) 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(TM)
CORDStrom(TM) 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(TM) 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(TM) 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(TM) product platform shares many similarities, including reagents, equipment, and procedures, with the Company's INKmune(R) 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(R) manufacturing facilities utilizing UK academic grant funding, CORDStrom(TM) 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(TM) 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(R)
INKmune(R) 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(R) treatment converts the patient's own NK cells into mlNK cells. In patients, INKmune(R) 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(R) is a patient friendly drug treatment that does not require pre-medication, conditioning or additional cytokine therapy to be given to the patients. INKmune(R) is easily transported, stored and delivered to the patient by a simple intravenous infusion as an out-patient. INKmune(R) 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(R) 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(TM)). The Natural Killer Cell Priming Platform includes INKmune(R) 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(TM), 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 that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that do not describe historical facts 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 a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03(TM), XPro1595 (XPro(TM)), and INKmune(R) are still in clinical trials or 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 in order to reflect any event or circumstance that may arise after the date of this release.
Company Contact:
David Moss
Chief Financial 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.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
December 31, December 31,
2024 2023
-------------- --------------
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 20,922 $ 35,848
Research and development tax credit
receivable 1,181 1,905
Other tax receivable 228 537
Prepaid expenses and other current
assets 331 1,510
Prepaid expenses -- related party - 142
---------- ----------
TOTAL CURRENT ASSETS 22,662 39,942
---------- ----------
Operating lease -- right of use
asset 307 414
Other assets 79 131
Acquired in-process research and
development intangible assets 16,514 16,514
---------- ----------
TOTAL ASSETS $ 39,562 $ 57,001
========== ==========
LIABILITIES, REDEEMABLE COMMON
STOCK AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts payable and accrued
liabilities $ 6,539 $ 7,901
Accounts payable and accrued
liabilities -- related parties 25 35
Deferred liabilities 517 489
Current portion of long-term debt,
net - 9,921
Operating lease, current liability 140 119
---------- ----------
TOTAL CURRENT LIABILITIES 7,221 18,465
---------- ----------
Long-term operating lease liability 244 397
---------- ----------
TOTAL LIABILITIES 7,465 18,862
---------- ----------
COMMITMENTS AND CONTINGENCIES
Redeemable common stock, $0.001 par
value; 0 and 75,697 shares issued
and outstanding, respectively (Note
9) - 799
---------- ----------
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,
22,280,451 and 17,950,776 shares
issued and outstanding,
respectively 22 18
Additional paid-in capital 195,754 159,143
Accumulated other comprehensive loss $(575.SI)$ (799)
Accumulated deficit (163,104) (121,022)
---------- ----------
TOTAL STOCKHOLDERS' EQUITY 32,097 37,340
---------- ----------
TOTAL LIABILITIES, REDEEMABLE COMMON
STOCK AND STOCKHOLDERS' EQUITY $ 39,562 $ 57,001
========== ==========
INMUNE BIO INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
(In thousands, except share and per share amounts)
2024 2023
----------- -----------
REVENUE $ 14 $ 155
OPERATING EXPENSES
General and administrative 9,483 9,623
Research and development 33,166 20,273
---------- ----------
Total operating expenses 42,649 29,896
---------- ----------
LOSS FROM OPERATIONS (42,635) (29,741)
---------- ----------
OTHER INCOME (EXPENSE), NET
Other income (expense), net 553 (267)
---------- ----------
Total other income (expense), net 553 (267)
---------- ----------
NET LOSS $ (42,082) $ (30,008)
========== ==========
Net loss per common share -- basic and
diluted $ (2.11) $ (1.67)
Weighted average number of common
shares outstanding -- basic and
diluted 19,944,304 17,980,791
COMPREHENSIVE LOSS
Net loss $ (42,082) $ (30,008)
Other comprehensive income (loss) --
foreign currency translation 224 (100)
---------- ----------
Total comprehensive loss $ (41,858) $ (30,108)
========== ==========
INMUNE BIO INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
(In thousands)
2024 2023
-------- --------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $(42,082) $(30,008)
Adjustments to reconcile net loss to net
cash used in operating activities:
Stock-based compensation 7,605 7,368
Accretion of debt discount 79 224
Changes in operating assets and
liabilities:
Research and development tax credit
receivable 724 6,194
Other tax receivable 309 (175)
Prepaid expenses and other current
assets 1,179 2,517
Prepaid expenses -- related party 142 (108)
Other assets 52 (32)
Accounts payable and accrued
liabilities (1,362) 2,695
Accounts payable and accrued
liabilities -- related parties (10) 26
Deferred liabilities 28 (127)
Accrued liability -- long-term - (550)
Operating lease liability (25) (4)
------- -------
Net cash used in operating activities (33,361) (11,980)
------- -------
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from sale of common stock
and warrants 27,789 775
Repayment of debt (10,000) (5,000)
Net proceeds from the exercise of stock
options 422 -
------- -------
Net cash provided by (used in)
financing activities 18,211 (4,225)
------- -------
Impact on cash from foreign currency
translation 224 (100)
NET DECREASE IN CASH (14,926) (16,305)
CASH AT BEGINNING OF YEAR 35,848 52,153
------- -------
CASH AT END OF YEAR $ 20,922 $ 35,848
======= =======
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS
INFORMATION:
Cash paid for income taxes $ - $ -
Cash paid for interest expense $ 1,690 $ 1,778
(END) Dow Jones Newswires
March 27, 2025 16:05 ET (20:05 GMT)
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