INmune Bio Inc. Announces Year End 2024 Results and Provides a Business Update
INmune Bio Inc. (NASDAQ: INMB) has released its financial results for the year ended December 31, 2024. The company reported significant progress across its three platform technologies:
For its DN-TNF Platform, the company completed enrollment of 208 patients in its Phase 2 AD02 trial for Early Alzheimer's Disease, with topline results expected in June 2025. The trial demonstrated strong performance of its EMACC cognitive measure tool.
The CORDStrom Platform showed positive results in treating Recessive Dystrophic Epidermolysis Bullosa (RDEB), receiving both Rare Pediatric Disease and Orphan Drug Designations from the FDA. The company plans to file a BLA in 2025 or early 2026.
The INKmune Platform demonstrated safety and increased NK-Cell activity in its Phase I/II trial for metastatic Castration-Resistant Prostate Cancer.
Financially, the company reported a net loss of $42.1 million for 2024, with R&D expenses of $33.2 million. The company raised approximately $27.5 million through securities purchase agreements and had cash and cash equivalents of $20.9 million as of December 31, 2024.
INmune Bio Inc. (NASDAQ: INMB) ha pubblicato i risultati finanziari per l'anno conclusosi il 31 dicembre 2024. L'azienda ha riportato progressi significativi nelle sue tre tecnologie di piattaforma:
Per la sua DN-TNF Platform, l'azienda ha completato l'arruolamento di 208 pazienti nel suo trial di Fase 2 AD02 per l'Alzheimer precoce, con risultati preliminari attesi per giugno 2025. Lo studio ha dimostrato una forte performance del suo strumento di misura cognitiva EMACC.
La CORDStrom Platform ha mostrato risultati positivi nel trattamento della Epidermolisi Bollosa Distrofica Recessiva (RDEB), ricevendo sia la designazione di Malattia Pediatrica Rara che quella di Farmaco Orfano dalla FDA. L'azienda prevede di presentare una BLA nel 2025 o all'inizio del 2026.
La INKmune Platform ha dimostrato sicurezza e un aumento dell'attività delle cellule NK nel suo trial di Fase I/II per il cancro alla prostata resistente alla castrazione metastatico.
Dal punto di vista finanziario, l'azienda ha riportato una perdita netta di 42,1 milioni di dollari per il 2024, con spese per R&S di 33,2 milioni di dollari. L'azienda ha raccolto circa 27,5 milioni di dollari attraverso accordi di acquisto di titoli e aveva disponibilità liquide e equivalenti per 20,9 milioni di dollari al 31 dicembre 2024.
INmune Bio Inc. (NASDAQ: INMB) ha publicado sus resultados financieros para el año que finalizó el 31 de diciembre de 2024. La compañía reportó un progreso significativo en sus tres tecnologías de plataforma:
Para su DN-TNF Platform, la compañía completó la inscripción de 208 pacientes en su ensayo de Fase 2 AD02 para la Enfermedad de Alzheimer Temprana, con resultados preliminares esperados para junio de 2025. El ensayo demostró un rendimiento sólido de su herramienta de medida cognitiva EMACC.
La CORDStrom Platform mostró resultados positivos en el tratamiento de la Epidermólisis Bullosa Distrofica Recesiva (RDEB), recibiendo tanto la designación de Enfermedad Pediátrica Rara como la de Medicamento Huérfano por parte de la FDA. La compañía planea presentar una BLA en 2025 o a principios de 2026.
La INKmune Platform demostró seguridad y un aumento en la actividad de células NK en su ensayo de Fase I/II para el cáncer de próstata resistente a la castración metastásico.
Financieramente, la compañía reportó una pérdida neta de 42,1 millones de dólares para 2024, con gastos de I+D de 33,2 millones de dólares. La compañía recaudó aproximadamente 27,5 millones de dólares a través de acuerdos de compra de valores y tenía efectivo y equivalentes de efectivo de 20,9 millones de dólares al 31 de diciembre de 2024.
INmune Bio Inc. (NASDAQ: INMB)는 2024년 12월 31일로 끝나는 회계연도의 재무 결과를 발표했습니다. 이 회사는 세 가지 플랫폼 기술에서 중요한 발전을 보고했습니다:
DN-TNF Platform의 경우, 회사는 조기 알츠하이머병을 위한 2상 AD02 시험에 208명의 환자를 등록 완료했으며, 주요 결과는 2025년 6월에 발표될 예정입니다. 이 시험은 EMACC 인지 측정 도구의 강력한 성과를 보여주었습니다.
CORDStrom Platform은 열성형성 피부박리증(RDEB) 치료에서 긍정적인 결과를 보여주었으며, FDA로부터 희귀 소아 질병 및 오르판 약물 지정을 받았습니다. 회사는 2025년 또는 2026년 초에 BLA를 제출할 계획입니다.
INKmune Platform은 전이성 호르몬 저항성 전립선암을 위한 1/2상 시험에서 안전성과 NK 세포 활성이 증가함을 입증했습니다.
재무적으로, 회사는 2024년에 4,210만 달러의 순손실을 보고했으며, R&D 비용은 3,320만 달러였습니다. 회사는 증권 구매 계약을 통해 약 2,750만 달러를 모금했으며, 2024년 12월 31일 기준으로 현금 및 현금성 자산은 2,090만 달러였습니다.
INmune Bio Inc. (NASDAQ: INMB) a publié ses résultats financiers pour l'année se terminant le 31 décembre 2024. La société a signalé des progrès significatifs dans ses trois technologies de plateforme :
Pour sa DN-TNF Platform, la société a terminé l'inscription de 208 patients dans son essai de Phase 2 AD02 pour la maladie d'Alzheimer précoce, avec des résultats préliminaires attendus en juin 2025. L'essai a démontré de solides performances de son outil de mesure cognitive EMACC.
La CORDStrom Platform a montré des résultats positifs dans le traitement de l'épidermolyse bulleuse dystrophique récessive (RDEB), recevant à la fois la désignation de maladie pédiatrique rare et celle de médicament orphelin de la FDA. La société prévoit de déposer une BLA en 2025 ou début 2026.
La INKmune Platform a démontré sa sécurité et une augmentation de l'activité des cellules NK dans son essai de Phase I/II pour le cancer de la prostate résistant à la castration métastatique.
Sur le plan financier, la société a déclaré une perte nette de 42,1 millions de dollars pour 2024, avec des dépenses de R&D de 33,2 millions de dollars. La société a levé environ 27,5 millions de dollars par le biais d'accords d'achat de titres et disposait de liquidités et équivalents de liquidités de 20,9 millions de dollars au 31 décembre 2024.
INmune Bio Inc. (NASDAQ: INMB) hat seine Finanzergebnisse für das Jahr zum 31. Dezember 2024 veröffentlicht. Das Unternehmen berichtete von erheblichen Fortschritten in seinen drei Plattformtechnologien:
Für die DN-TNF Platform hat das Unternehmen die Rekrutierung von 208 Patienten in seiner Phase-2-Studie AD02 für frühe Alzheimer-Krankheit abgeschlossen, wobei die Ergebnisse voraussichtlich im Juni 2025 veröffentlicht werden. Die Studie zeigte eine starke Leistung seines kognitiven Messinstruments EMACC.
Die CORDStrom Platform zeigte positive Ergebnisse bei der Behandlung der rezessiven dystrophischen Epidermolysis bullosa (RDEB) und erhielt sowohl die Auszeichnung als seltene pädiatrische Erkrankung als auch als Waisenarzneimittel von der FDA. Das Unternehmen plant, 2025 oder Anfang 2026 einen BLA einzureichen.
Die INKmune Platform zeigte Sicherheit und erhöhte NK-Zellaktivität in seiner Phase I/II-Studie für metastasierenden kastrationsresistenten Prostatakrebs.
Finanziell berichtete das Unternehmen für 2024 von einem Nettoverlust von 42,1 Millionen US-Dollar, mit F&E-Ausgaben von 33,2 Millionen US-Dollar. Das Unternehmen hat etwa 27,5 Millionen US-Dollar durch Wertpapierkaufverträge gesammelt und hatte zum 31. Dezember 2024 liquide Mittel und Zahlungsmitteläquivalente in Höhe von 20,9 Millionen US-Dollar.
- Completed enrollment of 208 patients in Phase 2 Alzheimer's trial, exceeding target of 201
- Received FDA Rare Pediatric Disease and Orphan Drug Designations for CORDStrom
- Raised $27.5 million through securities purchase agreements
- Demonstrated positive safety profile and efficacy in CORDStrom RDEB trial
- Strong cash position of $20.9 million as of December 2024
- Net loss increased to $42.1 million in 2024 from $30.0 million in 2023
- R&D expenses increased significantly to $33.2 million from $20.3 million in 2023
- Dilution from new share issuance through ATM program and securities purchase agreements
Insights
INmune Bio's year-end 2024 results reveal a widening net loss of $42.1M versus $30.0M in 2023, driven primarily by a 64% increase in R&D expenses to $33.2M as the company advances its clinical programs. The higher cash burn reflects the company's stage of development as it progresses multiple clinical trials simultaneously.
The company has strengthened its financial position through several funding initiatives, raising $27.5M from institutional investors with potential for an additional $30M through warrant exercises if AD02 trial results are positive. Combined with the $2.4M raised via ATM in 2024, $5.4M in early 2025, and a $2.5M R&D rebate from Australia, these actions have bolstered the company's cash reserves to $20.9M as of year-end.
The upcoming data readout from the AD02 Alzheimer's trial in June 2025 represents a pivotal catalyst that could significantly impact INmune's valuation. The Rare Pediatric Disease Designation for CORDStrom in RDEB also introduces potential for a valuable Priority Review Voucher, which could be monetized if approved by September 2026.
While the increased losses reflect typical biotech development progression, investors should monitor cash runway against the timeline to potential regulatory submissions, particularly the planned BLA filing for RDEB in 2025/2026 and the critical AD02 readout in June.
INmune's development pipeline shows meaningful clinical advancement across three distinct platforms. The DN-TNF platform's XPro has completed enrollment in its Alzheimer's Phase 2 trial with 208 patients, exceeding target enrollment. Interim analyses revealed strong performance of their proprietary EMACC cognitive measurement tool, which showed high correlation (p<0.001) with CDR-SB and exceptional reliability (0.93 correlation between measurements).
The CORDStrom platform delivered promising results in pediatric RDEB patients, demonstrating a 27% sustained reduction in itch at 6-months in severe patients and broader improvements in intermediate severity patients. The dual FDA designations (Rare Pediatric Disease and Orphan) enhance regulatory positioning and commercial potential.
For the INKmune platform in metastatic prostate cancer, the clean safety profile across 40+ infusions without premedication requirements creates a favorable administration profile. The successful advancement to Phase II dosing, combined with biomarker evidence of NK cell activation, validates the mechanism of action.
INmune is approaching several critical inflection points - the June 2025 AD02 readout could potentially validate their neuroinflammation approach in Alzheimer's, while the planned BLA filing for RDEB represents the company's first potential commercial product opportunity. The demonstrated 24-month stability validation for XPro also resolves a key manufacturing hurdle for potential Phase III studies and commercialization.
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™):
- 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 ΤNFR1-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™ on Proteins that regulate synapses in Alzheimer’s patients. The new analysis revealed that a 12-week treatment with XPro™ resulted in a significant change in synaptic proteins, which are essential for communication between neurons.
- Announced statistically significant improvements in electroencephalography (EEG), a biomarker of brain function, in patients with moderate to severe Alzheimer’s Disease treated with XPro™ for four weeks.
- Demonstrated 24-month stability validation of XPro™ for phase III readiness and commercial supply chain modeling & announced development of novel immunogenicity assay.
CORDStrom™ Platform
- Reported results of a double-blinded, randomized, placebo-controlled, cross-over study, known as “MissionEB,” investigating CORDStrom™ for treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) in pediatric patients, which evidenced a favorable benefit-risk profile.
- FDA granted CORDStrom™ 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™ was easily delivered, extremely well tolerated, with no serious adverse events related to CORDStrom™ 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™ 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™ 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™ 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™ as both caregivers and patients were able to correctly identify which treatment had been CORDStrom™ 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™ therapy at 0, 4 and 8 months. Each cycle of CORDStrom™ is a single infusion of CORDStrom™ 14 days apart.
INKmune® Platform:
- Announced that INKmune® 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® 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® 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® 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® 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® manufacturing, improving supply chain redundancy.
- Safety of INKmune® remains excellent. There have been more than 30 administrations of INKmune® 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® from the MDS/AML and mCRPC trials, over 40 infusions of INKmune® 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® 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® 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™ 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™ 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™
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 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 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 trials 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 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™, XPro1595 (XPro™), and INKmune® 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, 2024 | December 31, 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, | - | 799 | ||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Preferred stock, | - | - | ||||||
| Common stock, | 22 | 18 | ||||||
| Additional paid-in capital | 195,754 | 159,143 | ||||||
| Accumulated other comprehensive loss | (575 | ) | (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 | ||||
FAQ
When will INmune Bio (INMB) release topline results for its Alzheimer's Phase 2 trial?
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