INMB

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Chief Executive Officer - David J. Moss Chief Scientific Officer - Mark William Lowdell Need a quote from a Motley Fool analyst? Email [email protected] Operator: Welcome to INmune Bio's Second Quarter 26 Earnings Call. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question-and-answer session. You may press star 1 to ask a question. As a reminder, this conference call is being recorded. A transcript will be available approximately 24 hours after the call. Before we begin, please note that except for statements of historical fact, statements made by management and responses to questions may constitute forward looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 2000. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Please review the forward looking statements disclaimer in today's earnings release and the risk factors described in the company's filings with the SEC. Including its most recent quarterly report. Forward looking statements speak only as of the date they are made and except as required by law. INmune Bio undertakes no obligation to approve them. It is now my pleasure to turn the call over to INmune Bio's chief executive officer, David J. Moss. David J. Moss: Thank you for joining INmune Bio's second quarter conference call. The second quarter and the weeks that followed were defined by execution across both of our late stage platforms. I will begin with the investor perspective on the progress we have made I will then turn the call over to Dr. Mark William Lowdell, our chief scientific officer and the inventor of CORDStrom to discuss Ebstracel and the CORDStrom platform in greater detail. Cory Ellspermann will review our financial results and I will return to discuss the milestones ahead before we open the call for questions. For Ebstracel, we secured formal MHRA alignment received approval of the pediatric investigation plan, completed a commercial manufacturing milestone, and strengthened our long term supply chain. Together, these achievements materially reduced regulatory and operational risk ahead of our planned UK marketing authorization application. We now expect to submit the Ebstracel MAA by the end of Q3 or early Q4 2026. The application will seek conditional marketing authorization in RDEB, and is supported by written MHRA alignment across the CMC nonclinical, and clinical evidence packages. The agency also recognized the MISSION EV data as demonstrating clinical, meaningful, symptomatic benefits particularly in pain and pruritus. After submitting the MAA in The UK, we plan to submit the MAA to the EMA in early 2027 along with the BLA in The US seeking conditional approval. Manufacturing readiness has advanced in parallel. We successfully processed the first commercial ready umbilical cord at the cell and gene therapy catapult facility in Stevenage and transferred the MSC isolation stage used to manufacture master cell banks into the intended commercial facility. Combined with our expanded Anthony Nolan agreement, this gives us a scalable supply foundation designed to support UK, EU, and US filings and future commercial supply. We also advanced the CORDStrom platform patent into The US national phase and established a working scientific advisory board of international recognized MSC and RDEB experts. The SAB will help strengthen Ebstracel's late stage development package and prioritize additional disease specific applications of the CORDStrom platform. XPro also reached important milestones this quarter The FDA granted fast track designation for early Alzheimer's disease, and the phase 2 mindful study showed a statistically significant treatment effect on white matter myelin MRI biomarkers in the full intent to treat population. The teeth the treatment difference was p=0.0028 with a Cohen's effect size of 0.46. In the biomarker enriched population, the effect size increased further to 0.59. Expanded analysis presented at AAIC showed concordant treatment related effects across independent white matter cortical gray matter measures at week 24. These data, together with our successful end of phase 2 alignment with the FDA and publication of the mindful results in NPJ dementia, strengthen the clinical and regulatory foundation of the phase 2 b 3 program. The peer reviewed report showed directionally consistent benefit across clinical and biomarker endpoints in the prespecified inflammation rich subgroup with no amyloid related imaging abnormalities of abnormalities were observed. Recent TBI, traumatic brain injury, and oncology data also support broader platform optionality, although our clinical priority remains Alzheimer's disease we continue to evaluate strategic partnership opportunities that could accelerate the program while preserving meaningful value for Immune shareholders while we focus all of our attention and resources on getting Ebstracel to the RDEB patients in great need. With that, I will turn the call over to Dr. Mark William Lowdell to discuss CORDStrom program in greater detail. Mark? Mark William Lowdell: Thank you, David. I want to focus on 3 key areas in the road to bringing Ebstracel to the market that have been materially derisked since our last call. First, the regulatory package, the manufacturing and supply chain, and the broader platform from which Ebstracel is the first product to market. So first, the MHRA's official minutes from our May 20 twelfth pre MAA scientific advice meeting confirmed their alignment across every question that we submitted covering CMC, nonclinical, and clinical matters. This is important because it gives us a defined path for the planned conditional marketing authorization application rather than requiring us to infer what the agency might expect. Second, the MHRA approved the Ebstracel pediatric investigation plan in less than 3 months. The pediatric strategy incorporates the planned open label phase 3 confirmatory study and the agency's feedback recognized the MISSION EB phase 2 data as demonstrating clinically meaningful improvement in symptoms that matter to patients. Mostly pain and pruritus or itch. The feedback also supports evaluating Evstrocel as a chronic or intermittent supportive therapy in RDEB. Third, we completed a key commercial manufacturing milestone at the cell and gene therapy catapult center the manufacturing innovation center in Stevenage. For Ebstracel, and for subsequent cell drugs from the CORDStrom platform. The first commercial compliant cord tissue have been processed successfully, and the MSC isolation stage manufacture of the master cell banks was transferred into the facility intended to support registration and subsequently future commercial supply. Our expanded agreement with the Anthony Nolan and Cory Blood Bank secures long term access to qualified umbilical cord tissue for the platform for use in The UK, The EU, and The US. This matters because the CORDStrom platform was designed to solve 2 persistent challenges that we have seen in MSC therapy over the past years. Donor variability and manufacturing inconsistency. Our proprietary donor screening pooling, and expansion processes are intended to produce an off the shelf scalable, batch to batch consistent cell medicine and that is what we have shown the MHRA. The recent manufacturing work brings the initial master cell bank production stage into the commercial ready manufacturing supply chain. We have also strengthened the platform from which the Ebstracel lead program is derived. The CORDStrom patent application entered The US national phase following a favorable international written opinion, and if granted, could provide broad protection into at least 2020. In addition, our newly formed scientific advisory board brings together major leaders in MSC clinical translation, potency assessment, manufacturing, rare pediatric skin disease, and additional therapeutic areas that we can focus on. This is a working advisory board with defined priorities including phase 3 design, translational biomarker identification, potency and release assays, and selection of these additional indications. Taken together, these achievements give us greater confidence that the scientific, clinical, regulatory and manufacturing components required for a successful filing are now converging. Our immediate objectives is to submit The UK MAA by the end of Q3 or early Q4 this year, followed by the planned European and US while preparing the platform for future indications. I will now turn the call over to Cory for a review of our financial results. Cory Ellspermann? Cory Randall Ellspermann: Thank you, Mark. I will provide a brief overview of our financial results for the second quarter. Net loss attributable to common stockholders for the quarter ended 06/30/2026, was approximately $1.3 million compared to approximately $24.5 million for the quarter ended 06/30/2025. The prior period included a $16.5 million in impairment charge related to acquired in process research and development intangible assets. Research and development expenses totaled the benefit of approximately $800 thousand for the quarter ended 06/30/2026. Compared to approximately $5.8 million of expense for the quarter ended 06/30/2025. The research and development benefit during the 2026 period was primarily due to the recognition of additional Australian research and development rebate. General and administrative expenses were approximately $2.3 million for each of the quarters ended 06/30/2026, and 06/30/2025. As of 06/30/2026, the company had cash and cash equivalents of approximately $18.4 million And subsequent to 06/30/2026, we received approximately $4.2 million in Australian research and development tax rebate providing nondilutive capital to support our development programs. Based on our current operating plan, we believe our existing cash are sufficient to fund operations into the second quarter of 27. As of 08/06/2026, the company had approximately 27.8 million shares of common stock outstanding. David J. Moss: I will now turn the call back to David. Thank you, Cory. Before we open the call to for questions, I would like to leave you with a clear view of the value driving milestones ahead. INmune Bio now has 2 differentiated late stage platforms. Ebstracel is approaching global regulatory submissions with a commercial manufacturing and supply foundation in place. XPro is supported by FDA Fast Track designation, and the phase 2 alignment and statistically significant phase 2 imaging data. We believe this combination provides both a near term regulatory opportunity and meaningful long term pipeline value. Based on our current plans and subject to regulatory feedback, investors should watch for 4 principal milestones. First, we expect to submit the extracellular marketing authorization application to the UK MHRA this year seeking conditional marketing authorization in RDEB. Second, following The UK submission, we plan to submit Ebstracel to the European Medicines Agency expanding the regulatory strategy to patients across the European Union, early next year Third, we plan to submit Ebstracel Biologics license application to the US Food and Drug Administration in the first quarter of 27. Fourth, we continue advancing the XPro registrational strategy and evaluating strategic partnerships supported by FDA Fast Track designation, end of phase 2 alignment, and increasingly consistent clinical imaging evidence from MINDFUL. In parallel, we will continue commercial readiness work for Ebstracel including manufacturing, supply chain, market access, and distribution planning. The new CORDStrom Scientific Advisory Board will also begin against defined priorities for late stage development and platform expansion. Taken together, these activities provide a clear path to multiple regulatory and cert strategic value inflection points. Our priority is disciplined execution, completing high quality submissions, preserving capital, and building the capabilities required to deliver these therapies to patients. I want to thank our employees for their relentless dedication our investigators and clinical collaborators for their partnerships, the patients and families who have placed their trust in us, and our shareholders for their continued confidence and support. Our team is motivated, working tremendously hard, and is always thinking about the patients we serve and the and our dedicated to improving their lives. We believe the next several quarters can redefine INmune Bio as we move from clinical development toward regulatory review and potential commercialization. Look forward to updating you as we execute as we execute against these milestones. With that, I would like to move to questions and answers. Operator: Thank you. Thank you, ladies and gentlemen. We will now begin the and-answer session. Should you wish to cancel your request, please press the star followed by the 2. If you are using a speakerphone, please lift the handset before pressing any case. Your first question is from James Francis Molloy from Alliance Global Partners. Your line is now open. James Molloy: Hi, thank you very much for taking my question. On the Ebstracel, the open label phase 3 US trial, is that the 12-month open label safety trial you have discussed previously? Is this a different trial? David J. Moss: Hey, David. I am not sure if you are on mute. Sorry about that. Hi, James. it is David here. Because we are submitting self for conditional approval, we have a follow on trial that will be running during the, approval process. So this is a phase 3 confirmation trial. it is the same 1 we spoke about earlier. James Molloy: I think if Previously, we talked about a 12-month open-label safety trial. Not needed for filing. Is that this, or is the 12-month safe trial also going to be running in addition to this? David J. Moss: No. it is 1 trial. And it is a safety and confirmation trial. James Molloy: Okay. Alright. Because that is what you guys had already guided to this, and that is the 1 you talked about before. Okay. Very good. David J. Moss: that is right. James Molloy: And when you look at the UK filing, or the EU filing, sort of the next 2 filings, what you guys see as the biggest sort of the biggest thing they will be looking for that I think we obviously know the potential benefits. Of Ebstracel. What do you think are the biggest hurdles that you think they will be looking for against approval? And how you have addressed those. David J. Moss: Yeah. So the UK is very straightforward, very clear. We are very far along with the discussions that we have had with them. If you look at the top complaints from ED patients, RDEB patients, it is number 1, and 2 is pain and itch. And in fact, the FDA did a patient response outcome forum. I think in 2018. You can find it on YouTube in the from the FDA's website. And, again, the top complaints are itching and pain. And, clearly, itch is also related to wounds. You know, if you have an existing wound and you itch it, you introduce bacteria, you keep it from healing. These patients have such sensitive skin that even if they do not have a wound and they itch, they can very easily open up a wound. And so itch, if you talk to the investigators, they will clearly tell you that itch is a is a factor with wound healing and opening up new wounds. The regulators in, all 3 jurisdictions, realize that. there is published papers around that. So, you know, there have been trials also in itch. So we are moving forward with itch and pain as a primary endpoint, so we feel very confident about it. it is clear with the investigators. it is clear with the patients. And, you know, in our trial, we also did see in the EBDASI score, which was not the primary, pick up the wound scores later in the trial around the 6-month mark. Because if you think about it, over a period of time when you are not itching, takes a while to see those results in terms of wounds, and that is what we saw in the trial. James Molloy: Okay. And then what does the just going back to the trial, then I will get back in the queue. What does the open label confirmatory trial look like? And how many people how long I think 1, 12-months, I think, is a is the guidance. Correct? And what is the thinking on how long to enroll? Is it 12-months from start to finish when you start when you have the data? And what is the size of the trial? David J. Moss: Yeah. So we expect it to be somewhere around 40 to 45 patients. We already have about 33 lined up, ready to go. Most of those are the patients that were on the almost all of those are actually are the patients that were on the original trial that wanna stay on CORDStrom. We expect to enroll about 1 to 2 patients a week. We would like to enroll faster, but the PIs just cannot handle that kind of volume. And it will run a total of 18 months it is 3-- it is 3 sessions, 3 in-sessions of infusion that are, 6 in total. So every 10 days or so, they get 2 infusions 3 times a year for a total of 6 infusions. And we will have the data right around the middle of 28. James Molloy: Okay. Great. And then final question. I will hop in the queue. What does a potential approval in The UK what does a launch look like for you guys in The UK? How do you gear for that and that sort of thing. David J. Moss: No. it is a great question, James. So we ran this at the 2 leading centers that treat most of the children that have RDEB in the UK. They are the 2 leading children's hospitals for EB. and RDEB. it is where a good majority of the patients go. So, the beautiful thing about it is that the clinical investigators are already very familiar with, administering the drug. They are familiar with the results of the drug. And they have the patient population already. My James, is that within 2 years of approval in The UK, Given the 40 ish odd patients that will have on the trial plus the additional patients that we will add I expect that we should very comfortably within 2 years be right around 100 patients or so in The UK. James Molloy: Very much for taking my questions. David J. Moss: You are welcome, James. Operator: Thank you. I think we also have questions coming from Daniel. Daniel Frederick Carlson: Right. Yeah, David. So I have gotten a number of questions emailed into me, and I am gonna try and compile them for you. You pretty much covered the first question about the size of the opportunity, but there is a lot of people are asking if you can just clarify that the company's INmune focus for the foreseeable future is on the CORDStrom program. And then as sort of follow on to the market size, can you talk about the pricing of the drug and what the reimbursement process looks like in The UK? David J. Moss: Yes. Happy to do that. So first of all, let's talk population. So when you look at the greater EV population, it is generally about 10% to 15% of those suffer from the more severe form of RDEB. In The US, it is somewhere around 2,000 to 3 thousand patients in Europe. it is very similar to those numbers. And in The UK, it is somewhere around 800 or so patients in total. Now about 60% of those numbers represent children, and the rest represent adults is the breakdown. In terms of pricing, it is it is quite interesting because 1 of our competitors' products, Krystal's, which is by VYJUVEK, got approved in The UK. They are now going through the price negotiations. It will be interesting for us to watch that. But with the recent kind of MFN, and what we know about rare diseases, the pricing in The UK should be relatively close to what we expect in The US. We expect it somewhere around $400 thousand to $500 thousand per year per child. We will start our pricing negotiations right after we file the MAA. That will be the timeline for that. And if you look at what Krystal has done is they obviously got approval, and now they are in the process of the reimbursement negotiations. Now you also can get reimbursement before you have the pricing negotiations because the hospitals in The UK have the ability to pay and fund the medication while you are going through that process. There is a budgeting process within the hospitals there to do that. Did that answer the question, Daniel? Daniel Frederick Carlson: Yeah. That did and brought in some of my next question as well, which is which he took care of nicely. Thank you. Analyst: So the next question I have here so it basically, in light of recent positive developments, I am stunned at the current share price. and this is from an investor. I, for 1, believe a proper repricing should be in the cards. Would you care to comment? David J. Moss: Well, you know, I have always kind of beat on the drum that we are undervalued. Right? I mean, it is it is I really feel that way. But at the end of the day, I think what we have to do is we have to prove ourselves by getting the MA and getting the product approved. I will remind everybody that if we get it approved in The US, through accelerated approval, it already has orphan drug designation, and rare pediatric disease designation. The orphan drug means it an accelerated review process of about 6 months. The rare pediatric disease designation means it comes with what is called a priority review voucher Those priority review vouchers can be sold in the secondary market. The last few went for between $150 to around $200 million. So we like to see that between $102 million and $110 million, Which we intend to use to help fund the expansion of the CORDStrom platform and the XPro platform. In terms of value, I mean, just the PRV alone, obviously, is quite a bit larger than our current market cap. Really, what we do is we are just keeping our heads down We are being very cautious with resources. As you can see, we actually did not burn much this quarter. And we do not need a huge amount of cash to get to product approval. And so we are gonna be very judicious about our spending, and we are gonna be very judicious about how we raise money. I will remind shareholders that I am also 1 of the larger shareholders of this business being as is Mark. Being founders of this company, and so we are highly sensitive to dilution, which I think makes a little bit different than many other biotech companies. So we are going to be prudent. We do not need a huge amount of cash to get to where we need to go. And we are gonna be doing things like we did this last quarter by being just very special with R&D rebates, negotiating our spending, and being very careful about the amounts of money we raise and how we raise it. Daniel Frederick Carlson: Gotcha. Last question for you then. You did touch on this, but can you just, go over the burn rate as well and sort of capital market strategy? David J. Moss: Yes. So I will talk about capital strategy, and then, Cory, I will let you just make a little comment about burn rate. Daniel Frederick Carlson: So, you know, our capital market strategy is we are really turning our shareholder base over from the previous XPro shareholders. Into a rare disease shareholder base. it is a completely new shareholder base. And we have been spending a lot of time going non deal roadshows, talking to investors. We have been able to get a lot of our XPro shareholders back into the business. They understand the value of what we are doing with CORDStrom. We are starting to get some new ones now, especially as we get closer to proving ourselves with the MAA application and eventually approval in The UK. That being said, we are being very careful about spending. Cory, you wanna talk about, our last quarter burn rate and kind of the future burn rate? Cory Randall Ellspermann: Well, in general, I would say that we were our burn rate is maybe $1 million to $1.5 million per month. it is a little bit unusual what we had in the last 6 months because we took a lot of R&D rebates in, which is great. But we are not expecting R&D rebates in that amount on a go forward basis, at least over the next 12 months or so. So I would say $1 million or $1.5 million, and we have got cash into Q2 of next year. David J. Moss: Yep. Exactly. So not a huge burn rate. And, you know, the ability to raise that money you know, our goal is really just to raise money through the end of next year and do it very small, very judiciously. We just we it is not huge amount. Little bit here, little bit there. And we have got the ATM available to do that if we need to. And, you know, we expect to have approval in The UK sometime, I think, I am gonna say early Q2 next year, but let's just say Q2 the following year. and then we will start to be able to generate revenue. Daniel Frederick Carlson: Great. that is it for investor questions. Jenny, I will pass it back to you. Operator: Operator? Thank you. That concludes our conference call for today. Thank you everyone for joining. You may all disconnect your lines. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved formal MHRA alignment on the Ebstracel regulatory package, covering CMC, nonclinical, and clinical evidence to support a conditional marketing authorization application. Secured pediatric investigation plan approval in under three months, with regulators recognizing MISSION EB data as demonstrating clinically meaningful benefits in pain and pruritus. Completed a critical commercial manufacturing milestone by successfully processing the first commercial-ready umbilical cord and transferring master cell bank production to a registration-intended facility. Strengthened the CORDStrom platform's supply chain through an expanded agreement with Anthony Nolan, providing scalable access to qualified tissue for UK, EU, and US markets. Validated XPro's mechanism in Alzheimer's disease via statistically significant treatment effects on white matter myelin MRI biomarkers (p=0.0028) in the full intent-to-treat population. Maintained a disciplined capital allocation strategy, utilizing Australian R&D tax rebates to offset expenses and minimize shareholder dilution while focusing resources on the RDEB program. Expect to submit the Ebstracel MAA to the UK MHRA by late Q3 or early Q4 2026, followed by an EMA submission in early 2027. Planned US BLA submission for Ebstracel is targeted for Q1 2027, seeking conditional approval supported by orphan drug and rare pediatric disease designations. Anticipate initiating a Phase 3 confirmatory safety trial for Ebstracel involving 40 to 45 patients, with data expected by mid-2028. Projecting UK commercial revenue potential starting in Q2 2027, with pricing negotiations expected to align with US benchmarks of $400,000 to $500,000 per year per child. Evaluating strategic partnerships for the XPro platform to accelerate development in Alzheimer's and other indications while preserving core value for shareholders. Reported a significant reduction in net loss to $1.3 million, primarily due to the absence of prior-year impairment charges and the recognition of Australian R&D rebates. Confirmed cash runway into Q2 2027, supported by $18.4 million in cash and a subsequent $4.2 million R&D tax rebate received after the quarter's end. Highlighted the potential value of a Priority Review Voucher (PRV) upon US approval, noting recent secondary market transactions between $150 million and $200 million. Established a Scientific Advisory Board to prioritize CORDStrom platform expansion into additional disease-specific applications beyond RDEB. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. The trial will serve as both a safety and confirmatory study, enrolling approximately 40 to 45 patients at a rate of 1-2 patients per week. The study involves six total infusions per year (two infusions every 10 days, three times annually) with data expected by mid-2028. Management emphasized that itch and pain are the top patient concerns and are directly linked to wound healing and infection prevention. Regulators across all three jurisdictions have recognized these symptomatic benefits as clinically meaningful for RDEB patients. The company expects to reach approximately 100 patients in the UK within two years of approval by leveraging existing relationships with leading children's hospitals. Reimbursement can potentially be secured through hospital budgeting processes even before formal national price negotiations are finalized. Management expressed high sensitivity to dilution as founders and major shareholders, aiming for a 'judicious' and 'prudent' fundraising approach. The company is actively transitioning its investor base from Alzheimer's-focused shareholders to those specializing in rare diseases.

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. INmune Bio Inc (NASDAQ:INMB) secured formal MHRA alignment and approval of the pediatric investigation plan, materially reducing regulatory risk ahead of the planned UK marketing authorization application (MAA) submission by end of Q3 or early Q4 2026. The company completed a key commercial manufacturing milestone at the Cell and Gene Therapy Catapult facility, processing the first commercial-ready umbilical cord and transferring the MSC isolation stage into the intended commercial facility, strengthening the long-term supply chain. INmune Bio Inc (NASDAQ:INMB) received FDA Fast-Track designation for XPro in early Alzheimer's disease, and the Phase II mindful study showed statistically significant treatment effects on white matter myelin MRI biomarkers (P=0.0028, Cohen's effect size 0.46). The company's net loss for Q2 2026 was significantly reduced to approximately $1.3 million, compared to $24.5 million in Q2 2025, with the prior period including a $16.5 million impairment charge. INmune Bio Inc (NASDAQ:INMB) received approximately $4.2 million in Australian R&D tax rebates subsequent to quarter end, providing non-dilutive capital, and believes existing cash resources are sufficient to fund operations into Q2 2027. The Cordstrom platform patent application entered the U.S. national phase following a favorable international written opinion, potentially providing broad protection into at least 2045. INmune Bio Inc (NASDAQ:INMB) faces significant regulatory and operational hurdles in submitting the MAA to the MHRA by end of Q3 or early Q4 2026, with the EMA submission planned for early 2027 and the U.S. BLA in Q1 2027, leaving a tight timeline for multiple filings. The company's cash position of approximately $18.4 million as of June 30, 2026, is relatively low, and management acknowledges the need to raise additional capital, with a burn rate of $1 million to $1.5 million per month. INmune Bio Inc (NASDAQ:INMB) is heavily dependent on the success of Ebstracell for near-term value, and any delays or negative feedback from regulatory agencies could significantly impact the company's prospects. The Phase III confirmatory trial for Ebstracell is expected to enroll 40-45 patients with data available around mid-2028, meaning the company will not have confirmatory data for several years, which could affect conditional approval sustainability. The company's focus on Ebstracell means the XPro program for Alzheimer's disease is being deprioritized, and management is evaluating strategic partnerships, which could dilute value or result in less favorable terms for shareholders. INmune Bio Inc (NASDAQ:INMB) faces pricing and reimbursement uncertainties in the UK, with negotiations expected to start only after filing the MAA, and the company's projected pricing of 400,000-500,000 per year per child may face pushback from payers. Warning! GuruFocus has detected 5 Warning Signs with INMB. Is INMB fairly valued? Test your thesis with our free DCF calculator. Q: Can you clarify the details of the open-label Phase III confirmatory trial for Ebstracell, including its size, duration, and enrollment timeline?A: David Moss (CEO) confirmed that this is the same single safety and confirmation trial previously discussed, not a separate trial. The trial is expected to enroll approximately 40 to 45 patients, with about 33 already lined up, mostly from the original trial. Enrollment is expected to proceed at a rate of one to two patients per week. The trial will run for a total of 18 months, involving three sessions of infusions (two infusions every 10 days, three times a year, totaling six infusions). Data is expected around the middle of 2028. Q: What are the biggest hurdles regulators in the UK and EU will be looking for regarding Ebstracell approval, and how has the company addressed them?A: David Moss (CEO) explained that the top complaints from RDEB patients are pain and itch, which are the primary endpoints. The MHRA has already recognized the Mission-EB Phase II data as demonstrating clinically meaningful symptomatic benefits, particularly in pain and pruritus. The company is confident because itch is directly related to wound healing and the prevention of new wounds. The regulators in all three jurisdictions (UK, EU, US) recognize this, and the company's trial also picked up wound scores later in the trial (around the six-month mark), showing the long-term benefits of reducing itch. Q: What does a potential approval and launch in the UK look like for Ebstracell?A: David Moss (CEO) stated that the company ran the trial at the two leading children's hospitals in the UK that treat the majority of RDEB patients. The clinical investigators are already familiar with administering the drug and its results. He expects that within two years of approval, the company could comfortably reach around 100 patients in the UK, given the 40-odd patients on the trial plus additional patients. Q: Can you clarify the company's focus and discuss the market size, pricing, and reimbursement process for Ebstracell in the UK?A: David Moss (CEO) confirmed that the company's focus for the foreseeable future is on the Cordstrom program. He detailed the patient population: about 10% to 15% of the broader EB population suffer from severe RDEB, with roughly 2,000 to 3,000 patients in the US, similar numbers in Europe, and about 800 in the UK, with about 60% being children. Regarding pricing, he expects it to be around 400,000 to 500,000 per year per child, relatively close to expected US pricing. Pricing negotiations will start right after filing the MAA. He noted that hospitals in the UK have the ability to fund medication while pricing negotiations are ongoing. Q: In light of recent positive developments, the share price seems undervalued. Would you care to comment?A: David Moss (CEO) acknowledged that the company is undervalued but emphasized that they must prove themselves by getting the MAA and product approved. He highlighted that if approved in the US through accelerated approval, the drug already has orphan drug designation and rare pediatric disease designation. The rare pediatric disease designation comes with a priority review voucher (PRV), which can be sold in the secondary market for between $100 million and $200 million. He noted that the PRV alone is quite a bit larger than the current market cap. He reiterated that the company is being cautious with resources, has a low burn rate, and is highly sensitive to dilution as a founder and large shareholder. Q: Can you go over the burn rate and the capital market strategy?A: David Moss (CEO) and Corey Alspermann (CFO) explained that the burn rate is approximately $1 million to $1.5 million per month. The company has cash into Q2 of next year. The capital market strategy involves turning over the shareholder base from ex-pro shareholders to rare disease shareholders through non-deal roadshows. The goal is to raise money through the end of next year in small, judicious amounts, potentially using the ATM. They expect approval in the UK in Q2 of next year, after which they can start generating revenue. Q: What are the key regulatory milestones and achievements for Ebstracell this quarter?A: Dr. Mark Lodell (Chief Scientific Officer) detailed three key areas that have been de-risked: First, the MHRA's official minutes from the May 12th pre-MAA scientific advice meeting confirmed alignment across all questions covering CMC, non-clinical, and clinical matters. Second, the MHRA approved the Ebstracell pediatric investigation plan in less than three months, with feedback recognizing the Phase II data as demonstrating clinically meaningful improvement in pain and pruritus. Third, the company completed a key commercial manufacturing milestone at the Cell and Gene Therapy Catapult Center, successfully processing the first commercial-compliant cord tissues and transferring the MSC isolation stage into the intended commercial facility. Q: What is the status of the Cordstrom platform patent and the Scientific Advisory Board?A: Dr. Mark Lodell (Chief Scientific Officer) stated that the Cordstrom patent application entered the US national phase following a favorable international written opinion, which could provide broad protection into at least 2045 if granted. Additionally, the newly formed Scientific Advisory Board brings together leaders in MSC clinical translation, potency assessment, manufacturing, and rare pediatric skin disease. The board has defined priorities including Phase III design, translational biomarker identification, potency in release assays, and selection of additional indications. Q: What were the financial results for the second quarter of 2026?A: Corey Alspermann (CFO) reported a net loss of approximately $1.3 million for Q2 2026, compared to $24.5 million in Q2 2025, which included a $16.5 million impairment charge. R&D expenses were a benefit of approximately $0.8 million due to the recognition of additional Australian R&D rebates, compared to $5.8 million in expenses in the prior year. G&A expenses were approximately $2.3 million. The company had cash and cash equivalents of approximately $18.4 million as of June 30, 2026, and received approximately $4.2 million in Australian R&D tax rebates subsequent to quarter end. The company believes existing cash is sufficient to fund operations into Q2 2027. Q: What are the four principal milestones investors For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in INmune Bio, Inc.? Here are five stocks we like better. Regulatory and manufacturing progress: INmune Bio plans to seek conditional U.K. approval for Ebstrocel in late 2026, followed by applications in Europe and the U.S. The company reported MHRA alignment, pediatric plan approval, and progress toward commercial-scale production. Ebstrocel development and launch outlook: A confirmatory Phase III study is expected to enroll 40–45 RDEB patients, with results anticipated around mid-2028. Management estimates potential U.K. pricing of £400,000–£500,000 per child annually and expects to treat about 100 U.K. patients within two years of approval. Financial position and XPro progress: The company narrowed its second-quarter net loss to approximately $1.3 million and expects its cash, including a subsequent $4.2 million Australian tax rebate, to fund operations into Q2 2027. XPro also received FDA Fast Track designation after Phase II Alzheimer’s data showed significant improvements in white-matter myelin biomarkers. INmune Bio (NASDAQ:INMB) outlined plans to file for conditional approval of its Ebstrocel cell therapy in the United Kingdom by the end of the third quarter or early in the fourth quarter of 2026, while reporting a narrower second-quarter net loss and cash runway into the second quarter of 2027. Chief Executive Officer David Moss said the company’s second quarter and subsequent weeks were marked by regulatory, manufacturing and supply-chain progress for Ebstrocel, its lead product candidate from the CORDStrom platform. Ebstrocel is being developed for recessive dystrophic epidermolysis bullosa, or RDEB, a severe inherited skin disorder. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Moss said INmune Bio received formal alignment from the U.K. Medicines and Healthcare products Regulatory Agency, or MHRA, covering the chemistry, manufacturing and controls, non-clinical and clinical components of its planned marketing authorization application. The company intends to seek conditional marketing authorization for Ebstrocel in RDEB. Chief Scientific Officer Mark Lowdell said official MHRA meeting minutes from a May 12 pre-application scientific-advice meeting confirmed the agency’s alignment on each question submitted by the company. The MHRA also approved Ebstrocel’s pediatric investigation plan in less than three months, according to Lowdell. → Visa’s BioCatch Deal Could Make Fraud Prevention a Bigger Business Management said the agency recognized Phase II MissionEB data as demonstrating clinically meaningful symptomatic benefits, particularly for pain and pruritus, or itch. Moss said the company plans to use itch and pain as primary endpoints in its regulatory strategy, noting that persistent itching can contribute to wound formation and delayed healing among RDEB patients. Following the planned U.K. filing, INmune Bio expects to submit an application to the European Medicines Agency in early 2027 and a U.S. Biologics License Application seeking conditional approval in the first quarter of 2027. → Ulta's Growth Is Real, But So Are the Risks The company also reported progress toward commercial-scale production. It processed its first commercial-ready umbilical cord tissue at the Cell and Gene Therapy Catapult facility in Stevenage, England, and transferred the mesenchymal stromal cell isolation stage used to produce master cell banks to the intended commercial manufacturing site. INmune Bio expanded its agreement with the Anthony Nolan Cord Blood Bank, which management said provides long-term access to qualified umbilical cord tissue for prospective supply in the U.K., European Union and U.S. Lowdell said the CORDStrom platform is designed to address donor variability and manufacturing inconsistency through donor screening, pooling and expansion processes. The company’s CORDStrom patent application entered the U.S. national phase following what Lowdell described as a favorable international written opinion. If granted, the patent could provide protection through at least 2045, he said. INmune Bio also established a scientific advisory board to support Phase III trial design, biomarkers, potency and release assays, and potential additional indications for the platform. During the question-and-answer session, Moss said the planned open-label Phase III Ebstrocel study is the same safety and confirmatory study that the company had previously discussed. It is expected to enroll roughly 40 to 45 patients, including approximately 33 patients who have already been identified, primarily from the original trial. Management expects enrollment of one to two patients per week. The study is expected to run for 18 months and involve three treatment sessions, with two infusions given about 10 days apart during each session. Moss said the company expects data around the middle of 2028. Regarding a potential U.K. commercial rollout, Moss said Ebstrocel was studied at two leading U.K. children’s hospitals that treat a substantial portion of RDEB patients. He said investigators at those centers are familiar with administering the therapy and its clinical results. Moss said he expects the company could reach about 100 U.K. patients within two years of an approval, including trial participants and additional patients. Moss estimated that the U.K. has roughly 800 patients with epidermolysis bullosa overall, while 10% to 15% of the broader EB population has the more severe RDEB form. He said the U.S. and Europe each have approximately 2,000 to 3,000 RDEB patients. On pricing, Moss said INmune Bio expects annual pricing in the range of 400,000 pounds to 500,000 pounds per child in the U.K. The company plans to begin pricing discussions after filing its MHRA application. He said U.K. hospitals may have the ability to fund treatments while reimbursement and pricing negotiations are underway. INmune Bio also highlighted progress for XPro, its program for early Alzheimer’s disease. The FDA granted XPro Fast Track designation, while the Phase II MINDFuL study showed a statistically significant treatment effect on white-matter myelin MRI biomarkers in the full modified intent-to-treat population, management said. Moss reported a p-value of 0.0028 and a Cohen’s d effect size of 0.46 in the full population, increasing to 0.59 in a biomarker-enriched population. The company presented additional analyses at the Alzheimer’s Association International Conference that it said showed consistent treatment-related effects across independent white-matter and cortical gray-matter measures at week 24. Management said published MINDFuL results showed directionally consistent benefits across clinical and biomarker endpoints in a pre-specified inflammation-rich subgroup, with no amyloid-related imaging abnormalities observed. While Alzheimer’s remains the clinical priority for XPro, Moss said the company is evaluating partnership opportunities as it concentrates resources on Ebstrocel. For the quarter ended June 30, INmune Bio reported a net loss attributable to common stockholders of approximately $1.3 million, compared with a net loss of approximately $24.5 million in the year-earlier quarter. The 2025 period included a $16.5 million impairment charge related to acquired in-process research and development intangible assets. Research and development produced a benefit of approximately $0.8 million in the 2026 quarter, compared with $5.8 million in expense a year earlier, primarily due to recognition of an additional Australian research and development rebate. General and administrative expenses were approximately $2.3 million in both periods. The company had approximately $18.4 million in cash and cash equivalents as of June 30 and subsequently received about $4.2 million from an Australian R&D tax rebate. CFO Cory Ellspermann said existing resources are expected to fund operations into the second quarter of 2027. He estimated ongoing cash burn at approximately $1 million to $1.5 million per month, excluding the unusually high level of R&D rebates received during the prior six months. INmune Bio, Inc is a clinical-stage immunology company based in San Diego, California, focused on harnessing the innate immune system to combat a range of serious diseases. The company's research and development efforts concentrate on modulating cellular pathways to restore and enhance the body's natural defenses, particularly in oncology and neurodegenerative conditions. The company's lead therapeutic candidate, XPro1595 (also referred to as INB03), is a proprietary selective inhibitor of soluble tumor necrosis factor (TNF) designed to reduce chronic inflammation without impairing membrane-bound TNF functions. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "INmune Bio Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Company to Host Conference Call Today, August 6th, at 4:30pm ET BOCA RATON, Fla., Aug. 06, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced its financial results for the quarter ended June 30, 2026 and provided a business update. “The second quarter and subsequent weeks were defined by execution across both of our late-stage platforms,” said David Moss, Chief Executive Officer of INmune Bio. “For Ebstrocel™, we secured MHRA alignment, PIP approval and commercial-ready manufacturing, materially reducing regulatory and operational risk ahead of our planned UK MAA submission. For XPro™, FDA Fast Track designation and statistically significant MRI findings strengthened the clinical and regulatory foundation for a registrational Phase 2b/3 program in early Alzheimer’s disease that we believe establishes XPro™ as a first-in-class, late-stage neuroimmunology program in CNS disease. Looking ahead, our core priority is clear: driving Ebstrocel efficiently through regulatory filing and approval to bring this critical therapy to patients in need while delivering long-term value for our shareholders.” Second Quarter and Recent Corporate Highlights CORDStrom™ Platform (Ebstrocel for RDEB): Completed a key commercial manufacturing milestone by successfully processing the first commercial-ready umbilical cord tissues at the Cell and Gene Therapy Catapult Manufacturing Innovation Centre in Stevenage, UK. The transferred process is designed to meet MHRA, EMA and FDA standards and supports planned Phase 3 confirmatory development, global regulatory submissions and future commercial supply. Received formal MHRA written alignment across the CMC, non-clinical and clinical elements of the planned UK MAA, providing a clear regulatory path toward a Conditional Marketing Authorization application for Ebstrocel™ in RDEB. Obtained MHRA approval of the Ebstrocel™ Pediatric Investigation Plan in less than three months, preserving the Company’s planned 2026 UK MAA timetable and incorporating the agency’s feedback into the planned open-label Phase 3 confirmatory trial. Completed preparations for the Phase 3 trial of Ebstrocel in RDEB remaining on track for first patient treatment in Q4 2026. Advanced the CORDStrom™ platform patent application into the U.S. national phase following a favorable international Written Opinion. If granted, the patent family is expected to provide broad platform protection, including composition-of-matter and method-of-treatment claims, extending into at least 2045. Expanded the Company’s agreement with Anthony Nolan Cord Blood Bank, securing long-term access to high-quality umbilical cord tissue to support scalable global development and commercialization of the CORDStrom™ platform. Established a Scientific Advisory Board comprising internationally recognized leaders in MSC biology, clinical translation, manufacturing, potency assessment and rare pediatric skin disease. Chaired by Professor Mark Lowdell, the working SAB will support Ebstrocel’s late-stage regulatory and clinical development, including Phase 3 design, biomarkers, manufacturing consistency and product-release criteria, while helping prioritize additional indications for the CORDStrom platform. The SAB adds substantial independent expertise as the Company advances Ebstrocel toward regulatory submissions and expands CORDStrom into additional disease-specific cell therapies. XPro1595 Platform Highlights (XPro™): Reported a statistically significant treatment effect on a white matter myelin MRI biomarker in the Phase 2 MINDFuL trial. XPro™ demonstrated an effect in the full modified intent-to-treat population (p=0.0028; Cohen’s d=0.46; n=200), with a larger effect in the biomarker-enriched population (p=0.0098; d=0.59; n=100), supporting the precision-medicine strategy for the planned registrational program. Published the Phase 2 MINDFuL results in NPJ Dementia. In the pre-specified, protocol-defined Alzheimer’s Disease with inflammation (ADi) subgroup, XPro™ showed directionally consistent benefit across cognitive, global, functional, behavioral and biomarker endpoints over 24 weeks, with zero ARIA-E and zero ARIA-H observed. Presented expanded Phase 2 imaging analyses at the Alzheimer’s Association International Conference showing concordant treatment-related effects across independent white matter and cortical gray matter measures at Week 24, strengthening evidence of early biologic activity and tissue-level target engagement. Received FDA Fast Track designation for XPro™ (pegipanermin) for early Alzheimer’s disease, encompassing mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia, enabling more frequent FDA interactions and potential eligibility for expedited review mechanisms. Published a Department of Defense-funded, peer-reviewed Journal of Neurotrauma study showing that XPro1595 prevented the injury-induced rise in amyloid pathology and improved early cognitive and pain-related outcomes in a preclinical model linking traumatic brain injury to Alzheimer’s disease. Presented AACR 2026 preclinical data showing that INB03 (XPro1595 for oncology) enhanced the activity of HER2-targeted tyrosine kinase inhibitors and reduced metastatic spread to the brain, lungs and liver in HER2-positive breast cancer models. Corporate: Received an approximately US$4.2 million research and development tax rebate from Australia during July 2026, providing non-dilutive capital to support ongoing development activities. Announced it has been named a founding member of the American Biotech Innovation Alliance (ABIA). The newly launched national coalition brings together biotechnology leaders with the shared objective of defining a national strategy to sustain and extend U.S. leadership in biotech innovation. Upcoming Events and Milestones: Submit the Ebstrocel™ Marketing Authorization Application to the UK MHRA by the end of Q3 or early Q4 2026, followed by a planned European Union submission to the EMA in Q1 2027. Ebstrocel™ Biologics License Application (BLA) submission to the FDA expected in Q1 2027. Submit the registrational Phase 2b/3 protocol for XPro™ in early Alzheimer’s disease to the FDA in [Q4 2026]. Submit for publication the Phase 2 MINDFuL imaging analyses, including the white matter and cortical gray matter findings presented at AAIC 2026. Financial Results for the Second Quarter Ended June 30, 2026: Net loss attributable to common stockholders for the quarter ended June 30, 2026 was approximately $1.3 million, compared to approximately $24.5 million for the quarter ended June 30, 2025. The prior-year period included a $16.5 million impairment charge related to acquired in-process research and development intangible assets. Research and development expenses totaled approximately $(0.8 million) for the quarter ended June 30, 2026, compared to approximately $5.8 million for the quarter ended June 30, 2025. The research and development benefit during the 2026 period was primarily due to the recognition of additional Australian research and development tax rebate. General and administrative expenses were approximately $2.3 million for each of the quarters ended June 30, 2026 and June 30, 2025. As of June 30, 2026, the Company had cash and cash equivalents of approximately $18.4 million. As of August 6, 2026, the Company had approximately 27.8 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 Second Quarter Conference Call when reaching the operator. Date: August 6th, 2026 Time: 4:30 PM Eastern Time Participant Dial-in: 1-800-717-1738 Participant Dial-in (international): +1-646-307-1865 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=1769234&tp_key=7c277bcdb8 A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through September 21st, 2026 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN 1166817. About INmune Bio Inc. INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. Moving beyond early-stage exploration, the Company’s clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes. INmune Bio is actively advancing two late-stage product platforms toward registrational milestones: CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning to regulatory filing phases, with an MAA planned for the UK MHRA in 2026 and EU EMA in 2027, alongside a planned U.S. Biologics License Application (BLA) submission. XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform that selectively neutralizes soluble TNF (sTNF) to eliminate neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease. To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit www.inmunebio.com. Forward Looking Statements The Company’s product candidates are in clinical development 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 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 U.S. 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. INmune Bio Contacts: David Moss Chief Executive Officer (561) 710-0512 [email protected] Carlson Head of Investor Relations (415) 509-4590 [email protected] The following tables summarize our results of operations for the periods indicated:

Management to host conference call and webcast at 4:30 pm ET on that day BOCA RATON, Fla, July 31, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced t that it will host a conference call on Thursday, August 6th, 2026 at 4:30pm EDT to discuss results for its quarter ended June 30, 2026 and to provide a corporate update. Conference 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 Second Quarter Conference Call when reaching the operator. Date: August 6th, 2026 Time: 4:30 PM Eastern Time Participant Dial-in: 1-800-717-1738 Participant Dial-in (international): +1-646-307-1865 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=1769234&tp_key=7c277bcdb8 A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through September 21st, 2026 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering pin no. 1166817. About INmune Bio Inc. INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. Moving beyond early-stage exploration, the Company’s clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes. INmune Bio is actively advancing two late-stage product platforms toward registrational milestones: 1. CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning to regulatory filing phases, with an MAA planned for the UK MHRA and EU EMA in 2026, alongside a planned U.S. Biologics License Application (BLA) submission. 2. XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform that selectively neutralizes soluble TNF (sTNF) to eliminate neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease. To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, 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. INmune Bio Contacts: David Moss Chief Executive Officer (561) 710-0512 [email protected] Carlson Head of Investor Relations (415) 509-4590 [email protected]

Image source: The Motley Fool. Thursday, May 7, 2026 at 4:30 p.m. ET Chief Executive Officer — David Moss Chief Scientific Officer — Mark Lowdell Chief Medical Officer — Christopher Barnum Chief Financial Officer — Cory Ellspermann David Moss: Thank you, Dan, and good afternoon, everyone. Thank you for joining us for INmune Bio's Fourth Quarter and Full Year 2025 Earnings Call. Today, I'll begin with an overview of our progress and strategic priorities across the business. Mark will then provide an update on our CORDStrom platform with a focus on our RDEB program. CJ will follow with an update on XPro and our Alzheimer's disease development efforts. Cory will then review our financial results. After that, I'll return to highlight our key upcoming milestones before we open the call to questions. 2025 was a pivotal year for INmune Bio. We completed our MINDFuL Alzheimer's trial, advanced CORDStrom towards registration, and continue to position each of our platform programs for the next stage of development. As we move into '26, our focus is very clear. Execute against the most important regulatory clinical and strategic milestones across the portfolio. Starting with CORDStrom, this remains our most advanced program and a major value driver for the company. We recently presented additional patient data that further reinforces the therapeutic profile of CORDStrom in Recessive Dystrophic Epidermolysis Bullosa, or RDEB. These data showed clinical meaningful wound healing, reductions in itch and improvements in quality of life, all with a favorable safety profile. Based on this progress, we're in the final stages of preparing our regulatory submissions in both the U.K. and the United States, and we remain on track to file the MAA in the U.K. by the end of summer of '26. As Mark will tell you shortly, CORDStrom has a clear batch-to-batch manufacturing consistency, which makes the product reproducible ensuring commercial grade uniformity. Further, the clinical mechanism of action of CORDStrom for RDEB has been worked out along with the potency assays, which is an important step for regulators. The repeatable reliability -- the repeatable manufacturing reliability with the worked out MOA along with CMC readiness, safety and clinical results is what gives us confidence in the -- in CORDStrom for RDEB. Importantly, we want to highlight that CORDStrom is not simply a single asset opportunity, but as a platform with broader potential. Beyond RDEB, we believe the biology underlying the program may support development in additional inflammatory and degenerative conditions and over time, may also enable genetically modified applications in oncology and rare disease settings. Our immediate priority is to bring this therapy to patients with RDEB while also building the foundation for long-term platform expansion. Personally, there is no greater mission in my career than delivering CORDStrom to the children and families living with RDEB. Behind every trial result is a story that I've read and a face that I've seen in the video shared by these incredibly brave families. These images serve as a constant reminder of why we do what we do. Our team is deeply motivated by the human element of this condition, and we are working with an absolute urgency to bring this therapy to patients who need it most. Further, in our mission to develop medicines to unmet needs, I now turn to XPro for Alzheimer's disease. We believe this program is in the strongest position it has ever been. We completed MINDFuL, we've aligned with the FDA on the development path, and we're now preparing for a Phase III. This alignment effectively creates a preapproved blueprint for a partner to execute. CJ will give you the full picture shortly. On INKmune we completed our Phase II trial in metastatic castration-resistant prostate cancer ahead of schedule and under budget. The study met its primary endpoint and 2 of its 3 secondary endpoints. Mark will explain more on this later. Before I hand the call over, I want to thank patients and families who participated in the clinical studies, the investigators and trial sites, who supported this work, and our employees for their continued commitment and execution throughout the years. I also want to thank our shareholders for their continued support. Our strategy of advancing multiple differentiated platforms in parallel continues to create meaningful opportunities for value creation. We now have 1 platform approaching the regulatory stage, another with a completed Phase II study, an important translational data and 1/3 that has also generated encouraging clinical results. We believe '26 will be an important year for INmune Bios to work to advance CORDStrom towards approval, further clarifying the next steps for the Phase IIb trial for XPro and continue to build the partnerships and resources we need to move our programs forward. With that, I'll turn the call over to Mark Lowdell for an update on CORDStrom. Mark? Mark Lowdell: Thank you, David, and thank you to everyone who's joined the call today. Welcome. So as David said, CORDStrom showed great promise in the randomized placebo-controlled trial in RDEB, but it potentially extends way beyond RDEB to other forms of Epidermolysis Bullosa, and indeed to other conditions and indications. CORDStrom remains truly revolutionary in the MSC field. And last year, we reported on the fact that since it's created from mesenchymal stromal cell banks from 4 or more pooled donors, it really has unrivaled stability and reproducibility to compare to all of the other mesenchymal stromal or stem-cell products that are being developed or are on the market. Moreover, what we found is that the pooling allows us to select the individual mesenchymal stromal cell donor seedstocks, and we can choose those that have the appropriate potency characteristic for each disease indication, which allows us to tailor the final product to target different disease indications and thus have different drugs. As you know, RDEB is our first disease indication, and over the past 6 months, we've been able to dissect the precise mechanism of action of CORDStrom in RDEB. That's pretty unique for mesenchymal stromal cell product, while the diversity of the product means that working out quite how it delivers its effect is actually very challenging, but we now know that CORDStrom works by secreting an array of chemical messengers called cytokines, which are used by the body to control inflammation. We know that RDEB is predominantly a disease of inflammation, and it's driven by cells in the skin, which are called Type 1 macrophages or M1 cells. These M1 cells secrete inflammatory cytokines, which drive the itch and lead to the scratching, which causes the skin wounds so prevalent in RDEB patients, in which you'll be familiar with. M1 cells in normal skin also induce itch when provoked, but in RDEB patients, the absence of the protein which binds the skin layers together means that itch scratch cycle causes those very severe lesions that are so famous. One of the cytokines secreted by CORDStrom drives the M1 cells in the skin to mature into an M2 noninflammatory wound healing cells. We all have these and these M2 cells secrete a cytokine called IL-10, which switches off other INmune cells driving the itch-inducing cytokines. In parallel, the M2 cells also secrete other chemical messages cytokines, which enhance wound repair. And when we looked at the serum samples from the patients who were treated with CORDStrom on the U.K. trial and compared those to those treated with placebo. The CORDStrom recipients all had in their blood, cytokines that our mechanism of action predicted. And those patients that had the highest concentration reported much less pain, less itch and had better skin scores. They scored better in all measures of well-being and increased ability to eat. So this is the first RDBE treatment to have such diverse whole body clinical benefits, over and above those, which we see from the skin treatments that are already licensed. The patients, their caregivers and their doctors, all want to continue to have access to CORDStrom, and as David said, we're working tirelessly at present to submit the applications for marketing authorizations in the U.K., and then the European Union, and finally the U.S. before the end of the year. We are driving forward and they're all completed by the end of this year, and we hope to be supplying CORDStrom to RDEB patients in 2027. As I said earlier, the fact that CORDStrom is manufactured from a pool of 4 or more donor cell banks means that we can select the best donor cells for specific clinical indications. So while we are progressing with CORDStrom for RDEB and the marketing authorizations, my group of R&D scientists here in the U.K. are working on other broader indications and we're seeking business partnerships to develop those through clinical trials and bring those to market accordingly. So as a company, we're laser-focused on preparing the marketing authorization application for the U.K. and then the EU and the Biologics License Application, or BLA, for the U.S. by the end of 2026. These are highly aggressive time lines, but so far, we've met all of the deadlines that have been set, and I'm incredibly proud of our team in the U.K. for working so diligently to keep to these time lines to remain on track and to use all the resources that we have in the U.S. office to support. So I'm happy to take questions that you have, but meanwhile, I'll hand over to CJ for the latest update on XPro. CJ, floor is yours. Christopher Barnum: Thank you, Mark. I'll give you an update on XPro and where we're headed. MINDFuL was our Phase II trial in Alzheimer's disease. We designed it around a simple question. If we pick patients who have both Alzheimer's pathology, and signs of inflammation in their body, and we treat the inflammation, do they do better? What we saw was very encouraging. The results consistently favored XPro across clinical, behavioral patient-reported and blood and imaging biomarkers. The Phase I identified what works, who it works for and resolved the open questions so that Phase III can be successful. These results directly inform how we designed the Phase III program. We identified the patient population, those with both Alzheimer's pathology and biomarkers of inflammation. Decades of Alzheimer's research show that cognitive changes come first and functional changes follow with time. That's why the Phase III trial runs 18 months, long enough for the cognitive effects we saw at 6 months to show up on the functional measures the FDA requires for approval. The program is built as an adaptive trial with 2 stages. Phase IIb gives us a decision point at 9 months. a clear go or no go before we commit to the full Phase III investment. If the data hold, the trial continues seamlessly into the registrational stage with the CDR sum of boxes, the same primary endpoint used to approve lecanemab, and donanemab at 18 months. We presented this program to the FDA at the end of Phase II meeting earlier this year. The agency reviewed our data, our enrichment strategy, and our trial design and aligned with our approach. We are now moving forward on several fronts. On the development side, we continue to analyze the MINDFul data set to fully understand the impact of XPro treatment. At the same time, we are preparing the Phase III program for initiation, which includes finalizing the protocol based on the FDA's feedback and pursuing the partnerships and funding needed to execute it. There's a lot of work ahead, but the foundation is solid. I'll hand it back to David. I look forward to your questions. David? David Moss: Thanks, CJ. Before I hand the call to Cory to go through our financial results, I want to emphasize from a capital perspective, we remain committed to capital efficiency. Our strategy is built on hitting clear data-driven milestones that allow us to maximize shareholder value while minimizing unnecessary burn. We're focused on maintaining the lean execution-oriented culture that has brought us to this stage. With that, let me pass the call to Cory to go through our financial results. Cory? Cory Ellspermann: Thank you, David. Net loss attributable to common stockholders for the year ended December 31, 2025, was approximately $45.9 million compared to approximately $42.1 million for 2024. Research and development expenses totaled approximately $20.7 million for the year ended December 31, 2025, compared with approximately $33.2 million for 2024, with the decrease due to incurring lower expenses in connection with the Alzheimer's trial in 2025. G&A expenses was approximately $10.3 million for the year ended December 31, 2025, compared with approximately $9.5 million for 2024. We also recorded a full impairment of our intangible asset of $16.5 million in 2025 following the release of the Phase II results of the Alzheimer's trial, in which the trial did not meet the clinical endpoint. During 2025, the company sold 3 million shares of common stock for net proceeds of approximately $17.4 million in a registered direct offering. In addition, the company sold approximately 1.3 million shares of common stock for net proceeds of approximately $10.1 million under at-the-market offerings. At December 31, 2025, the company had cash and cash equivalents of approximately $24.8 million. And as of March 30, 2026, the company had approximately 26.6 million shares of common stock outstanding. Based on the current operating plan, we believe our cash is sufficient to fund our operations through Q1 2027. And now, I'll hand the call back to David. David Moss: Thanks, Cory. Now I'd like to present upcoming milestones for the company, and then we can start with the Q&A. For CORDStrom program, we have several significant milestones ahead, which will really set our track for 2027. As Mark mentioned, we're on track to file the MAA in the U.K. by mid-summer 2026. A few months after the MAA filing, we expect to submit the MAA to the EMA and then the BLA to the FDA towards the end of the year. We should have feedback from all 3 geographies in '27, if not, approvals by then. I mind investors that it's our belief that a successful BLA application would likely result in the company obtaining a priority review voucher from the FDA, given that the program already has orphan drug designation and rare pediatric disease designation. For XPro, we continue to make strong progress. We've now received the minutes from our end of Phase II meeting with the FDA, as CJ had mentioned, and we obtained positive initial feedback on the accelerated approval pathways or we're active preparing for next steps. We're advancing partnership and funding discussions to support late-stage development of XPro. Stepping back, we entered 2026 with a focused set of objectives and multiple meaningful opportunities to create value, while MINDFuL trial did not achieve its top line primary endpoint due to powering the patient population properly, the totality of XPro data set continues to support our conviction in the program's potential in Alzheimer's disease and other neuroinflammatory disorders. At the same time, we believe CORDStrom is advancing towards a potentially transformative regulatory and commercial inflection point with the broader platform still not fully reflected in the market. We appreciate the continued support of our shareholders and the commitment of our team as we work towards these goals. At this point, Cloey, I'd like you to tell people how they can ask questions and poll for questions. Operator: [Operator Instructions] And we'll take a question from Elmer Piros with Lucid Capital Markets. Elemer Piros: David, what I'd like to ask, and maybe Mark can help us out here. If there is any anticipated differences between an MAA and an FDA submission. Have you had interactions with the FDA, what might be their requirements different from the European or from the U.K. agency? Mark Lowdell: Yes, I'll -- that's a very good question. Yes. So we -- the last time we spoke to the FDA specifically was a little bit about 13 months ago? And what they came back with was some -- one of the things that's been at the top of my mindset is, -- all of the work we've done so far in RDEB, the products being made from umbilical cord donors from the U.K. and there is a sensitivity about using U.K. donor materials in the U.S. And so we asked the FDA specifically whether we would be allowed to use U.K. donor cords for the U.S. submission. And they came back and said, absolutely, yes, but we would have to screen the U.K. donors for the standard globally agreed infectious disease markers, but they'd have to be tested in U.S. labs in clear accredited labs. And so what we're doing at the moment is creating new master seedstock and from donors that we can ethically test in the U.S. So that's the biggest difference. We have to create a new master seedstock, which is ongoing at the moment. But because we -- as I said earlier on, we've worked out the mechanism of action. We now have potency assays. We've been able to demonstrate that we've made 4 different master seedstocks experimentally from U.K. donors, and they've all been consistent. So the next point is that we make for the FDA filing, which you're going through at the moment, will be those that we take through for commercialization globally. So that was the principal question that we had, and it was the principal answer that they came back with The rest of the questions they came back with were identical to those from the MHRA. So yes, we will present exactly the same data set. David Moss: Elmer, let me -- if you don't -- Elmer, if you don't mind, let me just add to that. So the plan is what's -- if you -- a few months -- a few weeks ago, we submitted essentially a pre-MAA package to the MHRA, which will -- which really effectively is like a Type B meeting and it kind of -- it kind of smooths the process of the full MAA application speeds the process up that we intend to file midsummer. Once we get the feedback from the MHRA, and as Mark will tell you, they've already set a face-to-face meeting with us. Once we get that, we'll put that together with the answers to whatever questions they have or whatever feedback they give us, and then we'll submit that as a Type B meeting to the FDA in preparation really like a pre-BLA in preparation of the BLA with the FDA. And so that will be the steps that will take place. I think that might have been a little bit of what you're asking, if I'm correct? Elemer Piros: Yes, yes, yes. And just maybe one more detail around this. So would you have to have the samples tested in U.S. labs before you submit or you can have that during the submission or during the evaluation and submit it when you have the results? Mark Lowdell: So what they will ask is for a confirmation that we will only supply drug into the U.S. from U.S. tested donors. But in point of fact, we're making the master cell batch now. So we will have products that have been made from U.S. tested donors before we submit the BLA. Elemer Piros: Yes. And maybe one question about the course -- the XPro program. David, have you had interest, any interactions with potential former partners at ABPD? upon feedback, you get . David Moss: No, good question, Elmer. We have ongoing discussions with some groups. And one of the things that now you have to realize, we've just got the end of Phase II minutes a few weeks ago, 3, 4 weeks ago now. And -- so everything is being factored out. But 1 of the things we intend on doing this is finding a group to help us on the BD perspective because there's just a lot of not just large pharma but midsized companies, that we think the program is very appropriate for because if you think about it, it's a relatively small investment to see the Phase IIb portion for obviously a very large market, potentially one of the largest markets. The Phase IIb portion reads out as we expect with the right patient population from what we've learned from the MINDFuL trial, then it's a very clear path to the registration program as CJ had talked about linking the cognitive aspects of EMAC to the cognitive aspects of CDR and then getting the functional scale of CDR, which comes after cognitive changes over time. So the link is very logical. The correlation between EMAC and CDR is very logical. And so we think that this package had explained appropriately to the midsized EBITDA biotech companies that have an interest in neurology, all the way up to the large pharma. I think it's going to be a very attractive program. Operator: And it does appear that there are no further questions at this time. I would like to hand it back to David Moss for any additional or closing remarks. David Moss: Thank you, Cloey. 2025 was a year of significant progress for INmune Bio. We completed and analyzed the MINDFuL Alzheimer's trial, advanced CORDStrom towards registration in RDEB and positioning commute for its next stage of development in prostate cancer. As we move toward through 2026, our priorities are very clear: advance CORDStrom's towards marketing approval in the U.K., EU and the U.S., secure regulatory clarity on the path forward for XPro and build the partnerships and financial support necessary to bring these programs to patients. On behalf of the entire INmune Bio team, thank you for your continued support and confidence in our mission. We look forward to updating you on our progress in the months ahead. Have a great evening, everybody. Operator: Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect. Before you buy stock in INmune Bio, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and INmune Bio wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $463,900!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,294,401!* That performance is why people listen. 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INmune Bio (INMB) Q4 2025 Earnings Transcript was originally published by The Motley Fool

Boca Raton, FL, May 15, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB), a clinical-stage biotechnology company developing therapies that target innate immune dysfunction, today announced that results from its Phase 2 MINDFuL trial in Alzheimer’s disease have been published in the peer-reviewed journal NPJ Dementia. The study evaluated the safety, biomarker engagement, and clinical efficacy of XPro™ (XPro1595, pegipanermin) in patients with mild Alzheimer’s disease characterized by biomarkers of inflammation. In a pre-specified analysis of the protocol-defined Alzheimer’s Disease with inflammation (ADi) subgroup, XPro™ showed directionally consistent benefit across cognitive, global, functional, behavioral, and biomarker endpoints over 24 weeks, with no amyloid-related imaging abnormalities (ARIA) observed. The publication, titled “XPro1595 in Early Alzheimer’s Disease with Inflammation: Results from the Phase 2 MINDFuL Trial,” discusses how XPro™ demonstrated consistent positive trends in a pre-specified enriched subpopulation (n=100) with amyloid-beta positivity and two or more inflammation biomarkers (hsCRP, ESR, HbA1c, or APOE ε4 allele). The paper further highlights the effect sizes (Cohen’s d) up to 0.27 across cognitive (EMACC, International Shopping List Test), Patient-Reported Outcomes (Goal Attainment), behavioral (Neuropsychiatric Inventory), and biomarker endpoints (pTau217 and GFAP), directionally consistent with an XPro™ treatment effect. These findings support prioritization of the enriched population in future studies to optimize detection of treatment effects. CJ Barnum, PhD, Vice President of Neuroscience at INmune Bio, said, “MINDFuL is the first peer-reviewed trial to prospectively identify Alzheimer’s patients by both amyloid pathology and a biomarker-defined inflammatory signature. In this pre-specified subgroup, we observed directional improvements across cognitive, global, functional, behavioral, and biomarker endpoints, with no ARIA. The cross-domain consistency tracks with the underlying biology and represents the type of signal a Phase 2 trial is designed to identify, forming the foundation of a Phase 3 program.” David Moss, CEO of INmune Bio, said, “The publication of the Phase 2 results from MINDFuL in NPJ Dementia, together with the FDA Fast Track designation, strengthens the value of the XPro platform. The trial also supports a biomarker-enriched (inflammation-enriched) strategy designed to improve future trial design and enhance the potential for clinical success, while reinforcing the broader potential of selective sTNF neutralization across inflammation-driven diseases.” The full paper is available on the NPJ Dementia website or by clicking here. For more information about the MINDFuL trial or for additional details about INmune Bio’s ongoing programs, please visit www.inmunebio.com. About XPro™ XPro™ is a next-generation, dominant-negative protein biologic that acts as a selective inhibitor of soluble tumor necrosis factor (sTNF). Unlike non-selective TNF inhibitors, XPro™ neutralizes the pathological driver — sTNF signaling through TNFR1 — while preserving transmembrane TNF (tmTNF) and its homeostatic signaling through TNFR2, which is essential for normal immune function, cellular repair, and host defense. By targeting innate immune dysfunction rather than broadly suppressing immune function, XPro™ is designed to selectively restore immune balance in the central nervous system. About INmune Bio Inc. INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company building therapeutics around the innate immune system. The company’s lead platform, Dominant-Negative Tumor Necrosis Factor (DN-TNF), is designed to selectively neutralize soluble TNF — a driver of innate immune dysfunction implicated across a range of inflammation-driven diseases. XPro™ (pegipanermin), the lead DN-TNF candidate, is in clinical development in Alzheimer’s disease with inflammation (ADi), with FDA Fast Track designation, and in treatment-resistant depression. INmune Bio’s two additional platforms — INKmune®, a natural killer cell priming platform in clinical development for metastatic castration-resistant prostate cancer, and CORDStrom™, an allogeneic human umbilical cord-derived mesenchymal stromal/stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa — extend the company’s precision immunology focus. To learn more, please visit www.inmunebio.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include any statements related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates. 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™, XPro™ (XPro1595, 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 manufacture sufficient drug supply for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release. INmune Bio Contacts: David Moss Co-founder and Chief Executive Officer (858) 964-3720 [email protected] Daniel Carlson Head of Investor Relations (415) 509-4590 [email protected]

Image source: The Motley Fool. Thursday, May 7, 2026 at 4:30 p.m. ET Chief Executive Officer — David Moss Chief Scientific Officer — Mark Lowdell Chief Financial Officer — Cory Ellspermann Need a quote from a Motley Fool analyst? Email [email protected] David Moss: Thank you, Daniel, and good afternoon, everyone. For our first quarter 2026 earnings call, today, I'll review key takeaways and provide an update on our platform programs. Following my review of recent developments at INmune Bio, I will pass the microphone to Dr. Lowdell, INmune Bio's CSO and inventor of CORDStrom, who will provide an update on our CORDStrom MSC platform and particularly our RDEB program. Next, Cory Ellspermann will provide our financial results, after which I'll conclude our prepared remarks. We entered 2026 with clear priorities and strong momentum across our platforms. Most importantly, our CORDStrom platform remains on track, and we are now approaching a key milestone with our regulatory filings. Based on the progress of our analyses, manufacturing readiness and regulatory preparation, we expect to file for approval beginning in the near term, and we remain confident in the time line that we previously outlined. CORDStrom represents a potential first systemic therapy for RDEB, and we believe the data continue to support both its clinical benefits and its broader platform potential. Execution against this filing is our top priority. Turning to XPro. While CJ is not speaking today, I want to emphasize that we continue to make meaningful progress. We are advancing additional imaging analysis from the MINDFuL study, including MRI data focused on myelin preservation and structural integrity. These data sets are important as they further characterize XPro's potential as a disease-modifying therapy. At the same time, we're exploring potential rare disease trials for XPro and potential partners as we define the path forward, including regulatory alignment late-stage development strategies. Naturally, we'll update the markets as these milestones develop. Overall, we believe we're well positioned across both platforms as we move through a catalyst-rich period for the company and a marked change potentially for the company as we get closer to commercialization. With that, I'll turn the call over to Mark Lowdell to provide more details on CORDStrom. Mark? Mark Lowdell: Thank you, David, and thank you to everyone that's joined the call. As David said, since our last earnings call, we've moved forward significantly in bringing CORDStrom to market, and it is our central aim. First, we submitted the pediatric investigation plan known as a PIP to the U.K. medicines regulator in February, and we were approved for rapid assessment and receiving their response on the 9th of April. No substantial issues were raised, and we anticipate submitting our final response in the next few days. The approval of the PIP is an essential step to complete prior to submission of the marketing authorization application in the U.K. and then to the EMA for Europe. We've started the first of the 3 process validation manufacturing runs on time and the remaining 2 are scheduled to meet our MAA submission deadline. Most significantly, we've concluded negotiations with the Anthony Nolan U.K. Cord Blood Bank this month to ensure secure supply of umbilical cords and allow testing by U.S. laboratories to meet the requirements laid down by the FDA in our Type B meeting last year. This agreement was signed yesterday and is the final step in getting the UCMSC isolation part of manufacturing process validated, ready for commercial manufacture. Facilitating our ability to manufacture consistent batches of CORDStrom, we're pleased to announce that we recently signed an amended material transfer agreement with Anthony Nolan. This expanded strategic collaboration secures the long-term reliable supply of these high-quality umbilical cord tissues from their world-class cord blood bank to further our CORDStrom platform. Having a consistent supply is essential for us, not only for regulatory authorities, but also to enhance our ability to take the CORDStrom platform forward into other disease indications. The marketing authorization application submission requires completion of a very significant body of documents in 5 sections. These are now well underway. And as part of the product definition section, we've had to determine the formal names for CORDStrom as applied to RDEB to show it's different to other formulations targeting other diseases in the future. The active ingredient was named by the World Health Organization as pobistrocel, and we've chosen a commercial drug name of Ebstracel for the formulation to be used in recessive dystrophic EB. In 2 weeks' time, we will meet with the MHRA for further advice about the marketing authorization submission filing in the U.K. and then start to finalize those documents. Some minor regulatory delays have meant that we expect to submit to the MHRA in early Q3, and we've contracted a U.K. company, TMC Pharma, with expertise in rare disease submissions to run the EMA and the FDA submissions in parallel to meet the end of the year deadline that we described before to you. Finally, I had the great privilege to speak at the Cure EB Annual General Meeting in London last month, which is one of the largest EB charities in the U.K. I presented our data and our plan was overwhelmed by the response from patients and carers who attended. They're desperate for us to get Ebstracel to the market and to open the next phase of the clinical trial in the U.K. We're doing our utmost to deliver on our promises to them and to you to get into commercial manufacturing and supply in 2027. I'll hand over to Cory now for an update of the current financials. Cory? Cory Ellspermann: Thank you, Mark. At this time, I'll provide a brief overview of our financial results. Net loss attributable to common stockholders for the quarter ended March 31, 2026, was approximately $5.4 million compared with approximately $9.7 million for the comparable period in 2025. Research and development expenses totaled approximately $3.6 million for the quarter ended March 31, 2026, compared with approximately $7.6 million for the comparable period in 2025. General and administrative expenses were approximately $2.2 million for the quarter ended March 31, 2026, compared with approximately $2.3 million for the comparable period in 2025. And at March 31, 2026, the company had cash and cash equivalents of approximately $21.4 million. Based on our current operating plan, we believe our cash is sufficient to fund our operations through Q1 of 2027. And as of May 7, 2026, the company had approximately 26.6 million shares of common stock outstanding. And now I'll hand the call back to David. David Moss: Thank you, Cory. To close, our focus is straightforward. We're executing towards regulatory filings for CORDStrom, which we believe represents a major inflection point for the company. At the same time, we're continuing to build the case for XPro through additional imaging data, exploring the future rare disease trials and ongoing partnership discussions aimed at advancing the program efficiently. We believe these efforts position INmune Bio for a significant year ahead with multiple opportunities to create value for both patients and shareholders. Due to travel schedules, we'll not be taking questions, and this concludes our prepared remarks. If you have further questions, please reach out to the contacts at the end of our press releases, Dan Carlson or myself via those phone numbers or e-mails. Thank you for joining us today. Operator: And thank you, ladies and gentlemen. This concludes today's conference call. We thank you for your participation, and you may now disconnect. Before you buy stock in INmune Bio, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and INmune Bio wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $475,926!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,296,608!* Now, it’s worth noting Stock Advisor’s total average return is 981% — a market-crushing outperformance compared to 205% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 8, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. INmune Bio (INMB) Q1 2026 Earnings Transcript was originally published by The Motley Fool

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 [email protected] Daniel Carlson Head of Investor Relations (415) 509-4590 [email protected] The following tables summarize our results of operations for the periods indicated: