Q2 2026 INmune Bio Inc Earnings Call

August 6, 2026

Operator: Welcome to Inmune Bio's Q2 2026 earnings call. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question-and-answer session, at which time you may press star one 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 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied.

Speaker #1: 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.

Operator: 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, InmuneBio undertakes no obligation to update them. It is now my pleasure to turn the call over to InmuneBio's Chief Executive Officer, David Moss.

Speaker #1: 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 update them. the call over to Inmune Bio's Chief Executive Officer, David Moss.

Speaker #1: Moss. them. It is now my pleasure to turn Thank

Speaker #2: 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.

David J. Moss: Thank you for joining InmuneBio's Q2 conference call. The Q2 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 Lowdell, our Chief Scientific Officer and the inventor of CORDStrom, to discuss Ebstrocel 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 Ebstrocel, 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 Authorisation Application.

David Moss: Thank you for joining InmuneBio's Q2 conference call. The Q2 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 Lowdell, our Chief Scientific Officer and the inventor of CORDStrom, to discuss Ebstrocel 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 Ebstrocel, 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 Authorisation Application.

Speaker #2: I will begin with the investor perspective on the progress we have made. I will then turn the call over to Dr. Mark Lowdell, our Chief Scientific Officer, and the inventor of Cordstrom to discuss EBSCO cell and the Cordstrom platform in greater detail.

Speaker #2: Cory Ellspermann will review our financial results, and I will return to discuss the milestones ahead before we open the call for questions. For EBSCO Cell, we secured formal MHRA alignment, received approval of the pediatric investigation plan, completed a commercial manufacturing milestone, and strengthened our long-term supply chain.

Speaker #2: Together, these achievements materially reduced regulatory and operational risk ahead of our planned UK marketing authorization application. We now expect to submit EBSCO cell MAA to the MHRA by the end of Q3 or early Q4 '26.

David J. Moss: We now expect to submit Ebstrocel MAA to the MHRA by the end of Q3 or early Q4 2026. The application will seek conditional marketing authorisation in RDEB and is supported by written MHRA alignment across the CMC, non-clinical, and clinical evidence packages. The agency also recognized the MissionEB 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 a BLA in the US seeking conditional approval. Manufacturing readiness has advanced in parallel. We successfully processed the first commercial-ready umbilical cord tissue 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.

David Moss: We now expect to submit Ebstrocel MAA to the MHRA by the end of Q3 or early Q4 2026. The application will seek conditional marketing authorisation in RDEB and is supported by written MHRA alignment across the CMC, non-clinical, and clinical evidence packages. The agency also recognized the MissionEB 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 a BLA in the US seeking conditional approval. Manufacturing readiness has advanced in parallel. We successfully processed the first commercial-ready umbilical cord tissue 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.

Speaker #2: The application will seek conditional marketing authorization in our debt and is supported by written MHRA alignment across the CMC non-clinical and clinical evidence packages.

Speaker #2: 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 '27 along with a BLA in the US seeking conditional approval.

Speaker #2: Manufacturing readiness has advanced in parallel. We successfully processed the first commercial ready umbilical cord tissue 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.

Speaker #2: 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.

David J. Moss: 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 application into the U.S. national stage and established a working scientific advisory board of international recognized MSC and RDEB experts. The SAB will help strengthen Ebstrocel's late-stage development package and prioritize additional disease-specific applications of the CORDStrom platform. XPro also reached important milestones this quarter. FDA granted Fast Track designation for early Alzheimer's disease, and 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. 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.

David Moss: 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 application into the U.S. national stage and established a working scientific advisory board of international recognized MSC and RDEB experts. The SAB will help strengthen Ebstrocel's late-stage development package and prioritize additional disease-specific applications of the CORDStrom platform. XPro also reached important milestones this quarter. FDA granted Fast Track designation for early Alzheimer's disease, and 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. 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.

Speaker #2: We also advanced the Cordstrom platform patent application into the US national phase and established a working scientific advisory board and our debt experts. The SAB will help strengthen EBSCO cell's late-stage development package and prioritize additional disease-specific applications of the Cordstrom platform.

Speaker #2: Expro 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 modified intent-to-treat population.

Speaker #2: was P0.0028 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 and cortical gray matter measures at week 24.

David J. Moss: Expanded analysis presented at AAIC showed concordant treatment-related effects across independent white matter and cortical gray matter measures at week 24. These data, together with our successful end of phase II alignment with the FDA and publication of the MINDFuL results in npj Dementia, strengthen the clinical and regulatory foundation of the phase II-B/III program. The peer-reviewed report shows directionally consistent benefit across clinical and biomarker endpoints in the pre-specified inflammation-rich subgroup with no amyloid-related imaging abnormalities 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 Inmune shareholders while we focus all of our attention and resources on getting Ebstrocel to the RDEB patients who are in great need.

David Moss: Expanded analysis presented at AAIC showed concordant treatment-related effects across independent white matter and cortical gray matter measures at week 24. These data, together with our successful end of phase II alignment with the FDA and publication of the MINDFuL results in npj Dementia, strengthen the clinical and regulatory foundation of the phase II-B/III program. The peer-reviewed report shows directionally consistent benefit across clinical and biomarker endpoints in the pre-specified inflammation-rich subgroup with no amyloid-related imaging abnormalities 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 Inmune shareholders while we focus all of our attention and resources on getting Ebstrocel to the RDEB patients who are in great need.

Speaker #2: These data together with our successful end of phase two alignment with the FDA and publication of the mindful results in NPJ Dementia strengthen the clinical and regulatory foundation of the phase two B3 program.

Speaker #2: The peer-reviewed report showed directionally consistent benefit across clinical and biomarker endpoints in the pre-specified inflammation-rich subgroup, with no amyloid-related imaging abnormalities 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 INmune shareholders. We are focusing all of our attention and resources on getting XPro1595 to our dementia patients who are in great need.

Speaker #2: With that, I will turn the call over to Dr. Mark Lowdell to discuss the Cordstrom program in greater detail. Mark.

David J. Moss: With that, I will turn the call over to Dr. Mark Lowdell to discuss CORDStrom program in greater detail. Mark?

David Moss: With that, I will turn the call over to Dr. Mark Lowdell to discuss CORDStrom program in greater detail. Mark?

Speaker #3: Thank you, David. I want to focus on three key areas on the road to bringing EBSCO cell to market that have been materially de-risked since our last call.

Mark Lowdell: Thank you, David. I want to focus on 3 key areas in the road to bringing Ebstrocel to the market that have been materially de-risked since our last call. First, the regulatory package, the manufacturing and supply chain, and the broader CORDStrom platform from which Ebstrocel is the first product to market. First, the MHRA's official minutes from our 12 May pre-MAA scientific advice meeting confirmed their alignment across every question that we submitted, covering CMC, non-clinical, and clinical matters. This is important because it gives us a defined path for the planned conditional marketing authorisation application, rather than requiring us to infer what the agency might expect. Second, the MHRA approved the Ebstrocel pediatric investigation plan in less than 3 months.

Speaker #3: First, the regulatory package, the manufacturing and supply chain, and the EBSCO cell is the first product to market. So first, the MHRA's official minutes from our May 12th pre-MAA scientific advice meeting confirmed their alignment across every question that we submitted covering CMC, non-clinical, and clinical matters.

Speaker #3: 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.

Speaker #3: Second, the MHRA approved the EBSCO cell pediatric investigation plan in less than three months. The pediatric strategy incorporates the planned open label phase three confirmatory study and the agency's feedback recognized the mission EB phase two data as demonstrating clinically meaningful improvement in symptoms that matter to patients.

Mark Lowdell: The pediatric strategy incorporates the planned open label phase III confirmatory study, and the agency's feedback recognized the MissionEB phase II data as demonstrating clinically meaningful improvement in symptoms that matter to patients, mostly pain and pruritus or itch. The feedback also supports evaluating Ebstrocel as a chronic or intermittent supportive therapy in RDEB. Third, we completed a key commercial manufacturing milestone at the Cell and Gene Therapy Catapult Manufacturing Innovation Centre in Stevenage for Ebstrocel and for subsequent cell drugs from the CORDStrom platform. The first commercial compliant cord tissues have been processed successfully, and the MSC isolation stage for manufacture of the master cell banks was transferred into the facility intended to support registration and subsequently future commercial supply.

Speaker #3: Mostly pain and pruritus, or itch. The feedback also supports evaluating EBSCO cell as a chronic or intermittent supportive therapy in our debt. Third, we completed a key commercial manufacturing milestone at the Cell and Gene Therapy Catapult Center and the Manufacturing Innovation Center in Stevenage for EBSCO cell, and for subsequent cell drugs from the Cordstrom platform.

Speaker #3: The first commercial compliant cord tissues have been processed successfully and the MSC isolation stage for manufacture of the master cell banks was transferred into the facility intended to support registration and subsequently future commercial supply.

Speaker #3: Our expanded agreement with the Anthony Nolan core blood bank secures long-term access to qualified umbilical cord tissue for the platform for use in the UK, the EU, and the US.

Mark Lowdell: Our expanded agreement with the Anthony Nolan Cord 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 two persistent challenges that we've 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've also strengthened the platform from which the Ebstrocel lead program is derived. The CORDStrom patent application entered the U.S. national stage following a favorable international written opinion, and if granted, could provide broad protection into at least 2045.

Speaker #3: This matters because the Cordstrom platform was designed to solve two persistent challenges that we've seen in MSC therapy over the past years: donor variability and manufacturing inconsistency.

Speaker #3: 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.

Speaker #3: The recent manufacturing work brings the initial master cell bank

Speaker #1: Production stage into the commercial ready manufacturing supply chain We've also strengthened the platform from which the SSL lead program is derived The chords from patent application entered the US national phase following a favorable international written opinion .

Speaker #1: And if granted , could provide broad protection into at least 2045 . 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 three design , translational biomarker identification , potency and release assays , and selection .

Mark Lowdell: 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 III 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 objective is to submit the UK MAA by the end of Q3 or early Q4 this year, followed by the planned European and US submissions while preparing the platform for future indications. I'll now turn the call over to Cory for a review of our financial results. Cory?

Speaker #1: Of these , additional indications . The taken together , these achievements give us greater confidence that the scientific , clinical , regulatory and manufacturing components required for a successful , highly and now converging our immediate objectives is to submit the UK mAh by the end of Q3 or early Q4 this year , followed planned European and US submissions .

Speaker #1: While preparing the platform for future indications, I'll now turn the call over to Corey for a review of our financial results. Corey.

Speaker #2: Thank you . Mark . I'll provide a brief overview of our financial results for the second quarter . Net loss attributable to common stockholders for the quarter ended June 30th , 2026 was approximately 1.3 million , compared to approximately 24.5 million for the quarter ended June 30th , 2025 .

Cory Ellspermann: Thank you, Mark. I'll provide a brief overview of our financial results for the Q2. Net loss attributable to common stockholders for the quarter ended 30 June 2026 was approximately $1.3 million, compared to approximately $24.5 million for the quarter ended 30 June 2025. The prior period included a $16.5 million impairment charge related to acquired in-process research and development intangible assets. Research and development expenses totaled the benefit of approximately $0.8 million for the quarter ended 30 June 2026, compared to approximately $5.8 million of expense for the quarter ended 30 June 2025. The research and development benefit during the 2026 period was primarily due to the recognition of additional Australian research and development rebate.

Speaker #2: The prior period included a 16.5 million impairment charge related to acquired in-process research and development , intangible assets , research and development expenses totaled the benefit of approximately 0.8 million for the quarter ended June 30th , 2026 , compared to approximately 5.8 million of expense for the quarter ended June 30th , 2025 .

Speaker #2: 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 June 30th , 2026 and June 30th , 2025 .

Cory Ellspermann: General and administrative expenses were approximately $2.3 million for each of the quarters ended 30 June 2026 and 30 June 2025. As of 30 June 2026, the company had cash and cash equivalents of approximately $18.4 million. Subsequent to 30 June 2026, we received approximately $4.2 million in Australian research and development tax rebate, providing non-dilutive capital to support our development programs. Based on our current operating plan, we believe our existing cash resources are sufficient to fund operations into Q2 2027. As of 6 August 2026, the company had approximately 27.8 million shares of common stock outstanding. I will now turn the call back to David.

Speaker #2: As of June 30th , 2026 , the company had cash and cash equivalents of approximately 18.4 million . In subsequent to June 30th , 2026 , we received approximately 4.2 million in Australian Research and Development Tax rebate , providing Non-dilutive capital to support our development programs Based on our current operating plan , we believe our existing cash resources are sufficient to fund operations into the second quarter of 2027 .

Speaker #2: As of August 6th , 2026 , the company had approximately 27.8 million shares of common stock outstanding I'll now turn the call back to David

Speaker #3: Thank you . Corey . Before we open the call for questions , I'd like to leave you with a clear view of the value driving milestones ahead Immune bio now has two differentiated late stage platforms .

David J. Moss: Thank you, Cory. Before we open the call for questions, I'd like to leave you with a clear view of the value-driving milestones ahead. INmune Bio now has two differentiated late-stage platforms. Ebstrocel is approaching global regulatory submissions with a commercial manufacturing and supply foundation in place. XPro is supported by FDA Fast Track designation, end of phase II alignment, and statistically significant phase II 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 four principal milestones. First, we expect to submit the Ebstrocel Marketing Authorisation Application to the UK MHRA this year, seeking conditional marketing authorisation in RDEB. Second, following the UK submission, we plan to submit Ebstrocel to the European Medicines Agency, expanding the regulatory strategy to patients across the European Union early next year.

David Moss: Thank you, Cory. Before we open the call for questions, I'd like to leave you with a clear view of the value-driving milestones ahead. INmune Bio now has two differentiated late-stage platforms. Ebstrocel is approaching global regulatory submissions with a commercial manufacturing and supply foundation in place. XPro is supported by FDA Fast Track designation, end of phase II alignment, and statistically significant phase II 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 four principal milestones. First, we expect to submit the Ebstrocel Marketing Authorisation Application to the UK MHRA this year, seeking conditional marketing authorisation in RDEB. Second, following the UK submission, we plan to submit Ebstrocel to the European Medicines Agency, expanding the regulatory strategy to patients across the European Union early next year.

Speaker #3: Extracel 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 two alignment and statistically significant phase two imaging data We believe this combination provides both a near-term regulatory opportunity , opportunity , and meaningful long term pipeline value .

Speaker #3: Based on our current plans and subject to regulatory feedback , investors should watch for four principal milestones . First , we expect to submit the Extracel marketing authorization application to the UK .

Speaker #3: MHRA this year , seeking conditional marketing authorisation in Rdeb . Second , following the UK submission , we plan to submit Extracel to the European Medicines Agency , expanding the regulatory strategy to patients across the European Union early next year Third , we plan to submit Extracel Biologics License application to the US Food and Drug Administration in the first quarter of 27 .

David J. Moss: Third, we plan to submit Ebstrocel Biologics License Application to the US Food and Drug Administration in Q1 2027. Fourth, we continue advancing the XPro registrational strategy and evaluating strategic partnerships supported by FDA Fast Track designation, end of phase II alignment, and increasingly consistent clinical imaging evidence from MINDFuL. In parallel, we will continue commercial readiness work for Ebstrocel, including manufacturing, supply chain, market access, and distribution planning. The new CORDStrom Scientific Advisory Board will also begin executing against defined priorities for late-stage development and platform expansion. Taken together, these activities provide a clear path to multiple regulatory and 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.

David Moss: Third, we plan to submit Ebstrocel Biologics License Application to the US Food and Drug Administration in Q1 2027. Fourth, we continue advancing the XPro registrational strategy and evaluating strategic partnerships supported by FDA Fast Track designation, end of phase II alignment, and increasingly consistent clinical imaging evidence from MINDFuL. In parallel, we will continue commercial readiness work for Ebstrocel, including manufacturing, supply chain, market access, and distribution planning. The new CORDStrom Scientific Advisory Board will also begin executing against defined priorities for late-stage development and platform expansion. Taken together, these activities provide a clear path to multiple regulatory and 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.

Speaker #3: Fourth , we continue advancing the Xpro Registrational strategy and evaluating strategic partnerships supported by FDA Fast Track designation . End of phase two alignment and increasingly consistent clinical and imaging evidence from mindful in parallel , we will continue commercial readiness work for Extracel , including manufacturing , supply chain , market access and distribution planning .

Speaker #3: The new quarter from the Scientific Advisory Board will also begin executing against defined priorities for late-stage development and platform expansion. Taken together, these activities provide a clear path to multiple regulatory and strategic value inflection points.

Speaker #3: Our priority is disciplined execution , completing high quality submissions , preserving capital and building the capabilities required to deliver these therapies to patients .

Speaker #3: 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 .

David J. Moss: 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 are 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. We look forward to updating you as we execute against these milestones. With that, I'd like to move to questions and answers. Thank you.

David Moss: 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 are 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. We look forward to updating you as we execute against these milestones. With that, I'd like to move to questions and answers. Thank you.

Speaker #3: Our team is motivated, working tremendously hard, and is always thinking about the patients we serve and are dedicated to improving their lives.

Speaker #3: We believe the next several quarters can redefine a new bio . As we move from clinical development toward regulatory review and potential commercialization , we look forward to updating you as we execute .

Speaker #3: We execute against these milestones With that , I'd like to move to questions and answers . Thank you

Speaker #4: Thank you . Ladies and gentlemen , we will now begin the question and answer session . Should you have a question , please press the star followed by the one on your touchtone phone .

Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touchtone phone. Should you wish to cancel your request, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. Once again, that is star one should you wish to ask a question. Your first question is from James Molloy from Alliance Global Partners. Your line is now open.

Speaker #4: Should you wish to cancel your request, please press the star followed by the two. If you are using a speakerphone, please lift the handset.

Speaker #4: Before pressing any keys . Once again , that is star one . Should you wish to ask a question Your first question is from James Malloy from Alliance Global Partners .

Speaker #4: Your line is now open.

Speaker #2: Hi .

James Molloy: Hi. Thank you very much for taking my question. On the Ebstrocel, the open-label phase III US trial, is that the 12-month open-label safety trial we had discussed previously, or is this a different trial?

James Molloy (Alliance Global Partners: Hi. Thank you very much for taking my question. On the Ebstrocel, the open-label phase III US trial, is that the 12-month open-label safety trial we had discussed previously, or is this a different trial?

Speaker #5: Thank you very much for taking my question on the extra cell The open label phase three US trial is that the 12 month open label safety trial we had discussed previously is is this a different trial

Speaker #6: Hey , David , I'm not sure if you're on mute

David J. Moss: Hey, David, I'm not sure if you're on mute. Sorry about that. Hi, James. It's David here. Because we are submitting Ebstrocel for conditional approval, we have a follow-on trial that'll be running during the approval process. This is a phase III confirmation trial. It's the same one we spoke about earlier.

Cory Ellspermann: Hey, David, I'm not sure if you're on mute.

Speaker #3: Sorry about that . Hi James . It's David here because we are submitting abstract for conditional approval . We have a follow on trial that will be running during the approval process .

David Moss: Sorry about that. Hi, James. It's David here. Because we are submitting Ebstrocel for conditional approval, we have a follow-on trial that'll be running during the approval process. This is a phase III confirmation trial. It's the same one we spoke about earlier.

Speaker #3: So this is a phase three confirmation trial . It's the same one we spoke about earlier

Speaker #5: I think previously we talked about a 12 month open label safety trial , not needed for filing . Is that this or is it a 12 month safety trial ?

James Molloy: I think, yeah, previously, we talked about a 12-month open-label safety trial not needed for filing. Is that this, or is the 12-month safety trial also going to be running in addition to this?

James Molloy (Alliance Global Partners: I think, yeah, previously, we talked about a 12-month open-label safety trial not needed for filing. Is that this, or is the 12-month safety trial also going to be running in addition to this?

Speaker #5: Also going to be running ? In addition to this ?

Speaker #3: No , it's one trial and it is it's it's safety . And confirmation trial

David J. Moss: No, it's one trial.

David Moss: No, it's one trial and it's safety and confirmation trial.

James Molloy: Okay.

David J. Moss: It's safety and confirmation trial.

Speaker #5: Okay . All right . So that's you guys had already guided to this and that's the one you talked about before . Okay .

James Molloy: Okay.

James Molloy (Alliance Global Partners: Okay.

David J. Moss: Yeah.

David Moss: Yeah.

James Molloy: All right. You guys had already guided to this, and that's the one you talked about before. Okay, very good.

James Molloy (Alliance Global Partners: All right. You guys had already guided to this, and that's the one you talked about before. Okay, very good.

Speaker #5: Very good .

Speaker #3: That's right .

David J. Moss: That's right.

David Moss: That's right.

Speaker #5: And when you look at the the UK filing or the EU filing , sort of the next two filings , what do you guys see as the biggest sort of the biggest thing they'll be looking for ?

James Molloy: When you look at the UK filing or the EU filing, sort of the next two filings, what do you guys see as sort of the biggest thing they will be looking for that I think we obviously know the potential benefits of Ebstrocel? What do you think are the biggest hurdles that you think they will be looking for against approval and how you have addressed those?

James Molloy (Alliance Global Partners: When you look at the UK filing or the EU filing, sort of the next two filings, what do you guys see as sort of the biggest thing they will be looking for that I think we obviously know the potential benefits of Ebstrocel? What do you think are the biggest hurdles that you think they will be looking for against approval and how you have addressed those?

Speaker #5: That I think we obviously know the potential benefits of cell . What do you think are the biggest hurdles that you think they'll be looking for ?

Speaker #5: Against against approval and how you've addressed those ?

Speaker #3: Yeah. So the UK is very straightforward, very clear. We're very far along with the discussions that we've had with them.

David J. Moss: Yeah. 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. In fact, the FDA did a patient response outcome forum, I think in 2018. You can find it on YouTube from the FDA's website. Again, the top complaints are itch and pain. Clearly, itch is also related to wounds. 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.

David Moss: Yeah. 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. In fact, the FDA did a patient response outcome forum, I think in 2018. You can find it on YouTube from the FDA's website. Again, the top complaints are itch and pain. Clearly, itch is also related to wounds. 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.

Speaker #3: If you look at the top , complaints from EV patients , rdeb patients , it's number one and two is pain and itch .

Speaker #3: And in fact , the FDA did a patient , a patient response outcome forum , I think in 2018 , you can find it on YouTube in the From the FDA's website .

Speaker #3: And again , the top complaints are itch and pain and clearly itch is also related to wounds . You . If you have an existing wound and you itch it , you introduce bacteria .

Speaker #3: You keep it from healing . These patients have such sensitive skin that even if they don't have a wound and they itch , they can very easily open up a wound .

Speaker #3: And so if you talk to the , the , the investigators , they'll clearly tell you that itch is , is a factor with wound healing .

David J. Moss: Itch, if you talk to the investigators, they will clearly tell you that itch is a factor with wound healing and persistent wounds and opening up new wounds. The regulators in all three jurisdictions realize that. There is published papers around that. There have been trials also in itch. We are moving forward with itch, pain as the primary endpoint, so we feel very confident about it. It is clear with the investigators, it is clear with the patients. In our trial, we also did in the ADASI score, which was not the primary, pick up the wound scores later in the trial, around the 6-month mark. If you think about it, over a period of time when you are not itching, it takes a while to see those results in terms of wounds, and that is what we saw in the trial.

David Moss: Itch, if you talk to the investigators, they will clearly tell you that itch is a factor with wound healing and persistent wounds and opening up new wounds. The regulators in all three jurisdictions realize that. There is published papers around that. There have been trials also in itch. We are moving forward with itch, pain as the primary endpoint, so we feel very confident about it. It is clear with the investigators, it is clear with the patients. In our trial, we also did in the ADASI score, which was not the primary, pick up the wound scores later in the trial, around the 6-month mark. If you think about it, over a period of time when you are not itching, it takes a while to see those results in terms of wounds, and that is what we saw in the trial.

Speaker #3: And persistent wounds . And opening up new wounds . The regulators in all three jurisdictions realize that there's published papers around that . So , you know , there have been trials also in itch .

Speaker #3: So we're moving forward with itch . Pain . As the primary endpoint . So we feel very confident about it . It's it's clear with the , the investigators , it's clear with the patients and , you know , in our trial , we also did in the Das score , which was not the primary pick up the wound scores later and later in the trial , around the six month mark .

Speaker #3: Because if you think about it , over a period of time , when you're not itching , it takes a while to see those results .

Speaker #3: In terms of wounds . And that's what we saw in the trial .

Speaker #5: Okay And then what does the just going back to the trial , then I'll get back in the queue . What does the the , the open label confirmatory trial look like ?

James Molloy: Okay. Just going back to the trial, then I will get back in the queue. What does the open-label confirmatory trial look like? How many people? I think 12 months, I think is the guidance, correct? What is the thinking on how long to enroll? Is it 12 months from start to finish-

James Molloy (Alliance Global Partners: Okay. Just going back to the trial, then I will get back in the queue. What does the open-label confirmatory trial look like? How many people? I think 12 months, I think is the guidance, correct? What is the thinking on how long to enroll? Is it 12 months from start to finish when you have the data, what's the size of the trial?

Speaker #5: And how many people how long ? I think 112 months I think is the is the guidance correct . And what's the thinking on how long to to enroll .

Speaker #5: Is it 12 months from start to finish from the start ? When you have the data and what's the size of the trial ?

David J. Moss: Right

James Molloy: when you have the data, what's the size of the trial?

Speaker #3: Yeah . So we expect it to be somewhere around 40 to 45 patients . We already have about 33 lined up ready to go .

David J. Moss: Yeah. We expect it to be somewhere around 40 to 45 patients. We already have about 33 lined up, ready to go. Almost all of those actually are the patients that were on the original trial that want to stay on CORDStrom. We expect to enroll about one to two patients a week. We'd like to enroll faster, the PIs just can't handle that kind of volume. It'll run a total of 18 months. It's three sessions of infusion that are six in total. Every 10 days or so, they get two infusions, three times a year for a total of six infusions. We'll have the data right around the middle of 2028.

David Moss: Yeah. We expect it to be somewhere around 40 to 45 patients. We already have about 33 lined up, ready to go. Almost all of those actually are the patients that were on the original trial that want to stay on CORDStrom. We expect to enroll about one to two patients a week. We'd like to enroll faster, the PIs just can't handle that kind of volume. It'll run a total of 18 months. It's three sessions of infusion that are six in total. Every 10 days or so, they get two infusions, three times a year for a total of six infusions. We'll have the data right around the middle of 2028.

Speaker #3: Most of those are the patients that were on the original . Almost all of those are are the patients that were on the original trial that want to stay on chord strum .

Speaker #3: We expect to enroll about 1 to 2 patients a week . We'd like to enroll faster , but the Pi's just can't handle that kind of volume .

Speaker #3: And it'll run a total of 18 months . It's it's three infusions . It's three sessions , three , three sessions of infusion that are six in total .

Speaker #3: So every , every ten days or so , they get two infusions three times a year for a total of six infusions . And , and we'll have the data right around the middle of 28 .

James Molloy: Okay, great. Final question I'll hop in the queue. What does a potential approval in the UK, what does a launch look like for you guys in the UK?

James Molloy (Alliance Global Partners: Okay, great. Final question I'll hop in the queue. What does a potential approval in the UK, what does a launch look like for you guys in the UK gear up for that sort of thing?

Speaker #5: Final question . I'll hop in the queue . What does a potential approval in the UK ? What does a launch look like for you guys in the UK ?

Speaker #5: Yeah, geared for that and that sort of thing.

David J. Moss: Yeah.

James Molloy: Gear up for that sort of thing.

Speaker #3: No that's a great question James . So we ran this at the two leading centers that treat the most of the children that have rdeb in the UK .

David J. Moss: No, that's a great question, James. We ran this at the two leading centers that treat the most of the children that have RDEB in the UK. They're the two leading children's hospitals for ED and RDEB. It's where a good majority of the patients go. The beautiful thing about it is that the clinical investigators are already very familiar with administering the drug, they're familiar with the results of the drug, and they have the patient population already. My expectation, James, is that within two years of approval in the UK, given the 40-ish odd patients that we'll have on the trial, plus the additional patients that we'll add, I expect that we should very comfortably within two years be right around 100 patients or so in the UK.

David Moss: No, that's a great question, James. We ran this at the two leading centers that treat the most of the children that have RDEB in the UK. They're the two leading children's hospitals for ED and RDEB. It's where a good majority of the patients go. The beautiful thing about it is that the clinical investigators are already very familiar with administering the drug, they're familiar with the results of the drug, and they have the patient population already. My expectation, James, is that within two years of approval in the UK, given the 40-ish odd patients that we'll have on the trial, plus the additional patients that we'll add, I expect that we should very comfortably within two years be right around 100 patients or so in the UK.

Speaker #3: The the two leading children's hospitals for EB and Rdeb . It's 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 .

Speaker #3: They're familiar with the results of the drug , and they have the patient population already . My expectation , James , is that within two years of approval in the UK , given the the 40 ish odd patients that we'll have on the trial , plus the additional patients that will add , I expect that we should very , very comfortably within two years .

Speaker #3: Be right around 100 patients or so in the UK

Speaker #5: Thank you very much for taking my questions .

James Molloy: Thank you very much for taking my questions.

James Molloy (Alliance Global Partners: Thank you very much for taking my questions.

Speaker #3: You're welcome . James

David J. Moss: You're welcome, James.

David Moss: You're welcome, James.

Speaker #4: Thank you . I think we also had questions coming from Dan , right ?

Operator: Thank you. I think we also have questions coming from Dan.

Dan: Right. Yeah, David, I've gotten a number of questions emailed into me, and I'm going to try and compile them for you. You pretty much covered the first question about the size of the opportunity, but 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?

Dan Carlson: Right. Yeah, David, I've gotten a number of questions emailed into me, and I'm going to try and compile them for you. You pretty much covered the first question about the size of the opportunity, but 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?

Speaker #6: Yeah . So I've gotten a number of questions emailed into me and I'm going to try and compile them for you . You pretty much covered the first question about the the size of the opportunity , but there's a lot of , a lot of people are asking if you can just clarify that the companies immune focus for the foreseeable future is on the course from program .

Speaker #6: And then as a 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 ?

Speaker #3: Yes . Happy to do that . So first of all , let's talk population . So when you look at the greater EB population , it's generally about 10 to 15% of those suffer from the more severe form of rdeb .

David J. Moss: Yes, happy to do that. First of all, let's talk population. When you look at the greater ED population, it's generally about 10% to 15% of those suffer from the more severe form of RDEB. In the US, it's somewhere around 2,000 to 3,000 patients. In Europe, it's very similar to those numbers. In the UK, it's 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's quite interesting because one of our competitor's products, Krystal Biotech's, which is VYJUVEK, got approved in the UK. They're now going through the price negotiation. It'll be interesting for us to watch that.

David Moss: Yes, happy to do that. First of all, let's talk population. When you look at the greater ED population, it's generally about 10% to 15% of those suffer from the more severe form of RDEB. In the US, it's somewhere around 2,000 to 3,000 patients. In Europe, it's very similar to those numbers. In the UK, it's 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's quite interesting because one of our competitor's products, Krystal Biotech's, which is VYJUVEK, got approved in the UK. They're now going through the price negotiation. It'll be interesting for us to watch that.

Speaker #3: In the US . It's somewhere around 2 to 3000 patients in the in Europe , it's very similar to those numbers . And in the UK it's somewhere around 800 or so patients in total .

Speaker #3: Now , about 60% of those numbers represent children . And the rest represent adults . It is the breakdown in terms of pricing .

Speaker #3: It's quite interesting because the one of our competitors products , crystals , which is Vidovic , got approved in the UK and they're now going through the price negotiation .

Speaker #3: So it'll 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 .

David J. Moss: 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 GBP 400,000 to 500,000 per year per child. We will start our pricing negotiations right after we file the MAA, will be the timeline for that. If you look at what Krystal Biotech has done is they obviously got approval and now they're 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're going through that process. There is a budgeting process within the hospitals there to do that. Does that answer the question, Dan?

David Moss: 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 GBP 400,000 to 500,000 per year per child. We will start our pricing negotiations right after we file the MAA, will be the timeline for that. If you look at what Krystal Biotech has done is they obviously got approval and now they're 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're going through that process. There is a budgeting process within the hospitals there to do that. Does that answer the question, Dan?

Speaker #3: We expect it somewhere around 400 to 500 zero pounds per year per child . We will start our pricing negotiations right after we file the Maa will be the timeline for that .

Speaker #3: And if you look at what Crystal has done is they obviously got approval and now they're in the process of the the reimbursement negotiations .

Speaker #3: 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're going through that process .

Speaker #3: There is a budgeting process within the hospitals there to do that . Does that answer the question ?

Speaker #6: Yeah , that that did . And brought in some of my next question as well , which is he took care of nicely .

Dan: Yeah, that did and brought into my next question as well, which he took care of nicely. Thank you. The next question I have here, basically in light of recent positive developments, I'm stunned at the current share price. This is from an investor. I, for one, believe a proper repricing should be in the cards. Would you care to comment?

Dan Carlson: Yeah, that did and brought into my next question as well, which he took care of nicely. Thank you. The next question I have here, basically in light of recent positive developments, I'm stunned at the current share price. This is from an investor. I, for one, believe a proper repricing should be in the cards. Would you care to comment?

Speaker #6: Thank you so the next question I have here , so basically , in light of recent positive developments , I am stunned at the current share price .

Speaker #6: I and this is from an investor , I for one , believe a proper repricing should be in the cards . Would you care to comment ?

Speaker #3: Well , you know , I've always kind of beat on the drum that we are Undervalued right . I mean it's I really feel that way .

David J. Moss: Well, I've always kind of beat on the drum that we are undervalued, right? I really feel that way. At the end of the day, I think what we have to do is we have to prove ourselves by getting the MAA and getting the product approved. I'll 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's an accelerated review process of about 6 months. The Rare Pediatric Disease Designation means it comes with what's called a Priority Review Voucher. Those Priority Review Vouchers can be sold on the secondary market. The last few went for between $150 to around $200 million.

David Moss: Well, I've always kind of beat on the drum that we are undervalued, right? I really feel that way. At the end of the day, I think what we have to do is we have to prove ourselves by getting the MAA and getting the product approved. I'll 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's an accelerated review process of about 6 months. The Rare Pediatric Disease Designation means it comes with what's called a Priority Review Voucher. Those Priority Review Vouchers can be sold on the secondary market. The last few went for between $150 to around $200 million.

Speaker #3: But at the end of the day , I think what we have to do is we have to prove ourselves by getting the mAh and getting the product approved .

Speaker #3: I'll 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 .

Speaker #3: The orphan drug means it's an accelerated review process of about six months . The rare pediatric disease designation means it comes with what's called a priority review voucher .

Speaker #3: Those priority review vouchers can be sold on the secondary market . The last for between 150 to around 200 million . So we like to say they're between 100 and 200 million , which we intend to use to help fund the expansion of the courts from platform and the expo platform .

David J. Moss: We like to say they're between $100 million and $200 million, which we intend to use to help fund the expansion of the CORDStrom platform and the XPro platform. In terms of value, just the PRV alone obviously is quite a bit larger than our current market cap. Really what we do is we're just keeping our heads down. We're being very cautious with resources. As you can see, we actually didn't burn much this quarter, and we don't need a huge amount of cash to get to product approval. We're going to be very judicious about our spending, and we're going to be very judicious about how we raise money. I'll remind shareholders that I'm also one of the larger shareholders of this business, as is Mark, being founders of this company.

David Moss: We like to say they're between $100 million and $200 million, which we intend to use to help fund the expansion of the CORDStrom platform and the XPro platform. In terms of value, just the PRV alone obviously is quite a bit larger than our current market cap. Really what we do is we're just keeping our heads down. We're being very cautious with resources. As you can see, we actually didn't burn much this quarter, and we don't need a huge amount of cash to get to product approval. We're going to be very judicious about our spending, and we're going to be very judicious about how we raise money. I'll remind shareholders that I'm also one of the larger shareholders of this business, as is Mark, being founders of this company.

Speaker #3: If you in terms of value , I mean just the PRV alone , obviously is quite a bit larger than our current market cap .

Speaker #3: Really what we do is we're just keeping our heads down . We're being very cautious with resources . As you can see , we actually didn't burn much this quarter and and we don't need a huge amount of cash to get to product approval .

Speaker #3: And so we're going to be very judicious about our spending . And we're going to be very judicious about how we raise money .

Speaker #3: I'll remind shareholders that I'm also one of the larger shareholders of this business , being as is Mark being founders of this company .

Speaker #3: And so we're highly sensitive to dilution , which I think makes us a little bit different than many other biotech companies . So we're we're we're going to be prudent .

David J. Moss: We're highly sensitive to dilution, which I think makes us a little bit different than many other biotech companies. We're going to be prudent. We don't need a huge amount of cash to get to where we need to go, and we're going to 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.

David Moss: We're highly sensitive to dilution, which I think makes us a little bit different than many other biotech companies. We're going to be prudent. We don't need a huge amount of cash to get to where we need to go, and we're going to 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.

Speaker #3: We don't need a huge amount of cash to get to where we need to go . And we're going to be doing things like , we did this last quarter by being just very special with R&D rebates , negotiating our spending and our and , and being very careful about the amounts of money we raise and how we raise it

Speaker #5: Gotcha

Dan: Got you. Last question for you. Can you just go over the burn rate as well and sort of capital market strategy?

Dan Carlson: Got you. Last question for you. Can you just go over the burn rate as well and sort of capital market strategy?

Speaker #6: Last question for you . Then . You did touch on this , but can you just go over the burn rate as as well ?

Speaker #6: And sort of capital market strategy ?

Speaker #3: Yeah . So I'll talk about capital market strategy . And then Corey , I'll let you just make little comment about burn rate .

David J. Moss: Yeah. I'll talk about capital market strategy, and then Cory, I'll let you just make a little comment about burn rate. Our capital market strategy is we're really turning our shareholder base over from the previous XPro shareholders into a rare disease shareholders. It's a completely new shareholder base. We've been spending a lot of time going non-deal roadshows, talking to investors. We've been able to get a lot of our XPro shareholders back into the business. They understand the value of what we're doing with CORDStrom, we're 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're being very careful about spending. Cory, you want to talk about our last quarter burn rate and kind of the future burn rate?

David Moss: Yeah. I'll talk about capital market strategy, and then Cory, I'll let you just make a little comment about burn rate. Our capital market strategy is we're really turning our shareholder base over from the previous XPro shareholders into a rare disease shareholders. It's a completely new shareholder base. We've been spending a lot of time going non-deal roadshows, talking to investors. We've been able to get a lot of our XPro shareholders back into the business. They understand the value of what we're doing with CORDStrom, we're 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're being very careful about spending. Cory, you want to talk about our last quarter burn rate and kind of the future burn rate?

Speaker #3: So , you know , our capital market strategy is , is we're , we're really turning our shareholder base over from the previous ex pro shareholders into a rare disease shareholders .

Speaker #3: It's a completely new shareholder base . And we've been spending a lot of time going Non-deal roadshows talking to investors . We've been able to get a lot of our shareholders back into the business .

Speaker #3: They understand the value of what we're doing with Nordstrom , and we're starting to get some new ones now , especially as we get closer to proving ourselves with the Ma application and eventually approval in the UK That being said , we're being very careful about spending .

Speaker #3: Corey , do you want to talk about our last quarter burn rate and kind of the future burn rate ?

Speaker #2: Well , in general , I'd say that we were our burn rate is maybe 1 million to 1,000,005 per month . It's a little bit unusual what we had in the last six months , because we took a lot of R&D rebates in , which was great , but we're not expecting R&D rebates in that amount on a go forward basis , at least over the next 12 months or so .

Cory Ellspermann: Well, in general, I'd say that our burn rate is maybe $1 million to $1.5 million per month. It's a little bit unusual what we had in the last six months because we took a lot of R&D rebates in, which was great, but we're not expecting R&D rebates in that amount on a go-forward basis, at least over the next 12 months or so. I'd say $1 million or $1.5 million, and we've got cash into Q2 of next year.

Cory Ellspermann: Well, in general, I'd say that our burn rate is maybe $1 to 1.5 million per month. It's a little bit unusual what we had in the last six months because we took a lot of R&D rebates in, which was great, but we're not expecting R&D rebates in that amount on a go-forward basis, at least over the next 12 months or so. I'd say $1 million or $1.5 million, and we've got cash into Q2 of next year.

Speaker #2: So I'd say $1 million or $1.5 million. And we've got cash into Q2 of next year.

Speaker #6: Yep .

David J. Moss: Yep. Exactly. Not a huge burn rate. The ability to raise that money, our goal is really just to raise money through the end of next year and do it very small, very judiciously. It's not a huge amount. A little bit here, a little bit there. We've got the ATM available to do that if we need to. We expect to have approval in the UK sometime, I think I'm going to say early Q2 next year, but let's just say Q2 the following year, then we'll start to be able to generate revenue.

David Moss: Yep. Exactly. Not a huge burn rate. The ability to raise that money, our goal is really just to raise money through the end of next year and do it very small, very judiciously. It's not a huge amount. A little bit here, a little bit there. We've got the ATM available to do that if we need to. We expect to have approval in the UK sometime, I think I'm going to say early Q2 next year, but let's just say Q2 the following year, then we'll start to be able to generate revenue.

Speaker #3: 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 .

Speaker #3: And do it very small , very judiciously . We just it's not a huge amount a little bit here , a little bit there .

Speaker #3: And we've got the ATM available to do that . If we need to . And , and , you know , we expect to have approval in the UK sometime .

Speaker #3: I think I'm going to say early Q2 next year , but let's just say Q2 the following year , and then we'll start to be able to generate revenue Great .

Dan: Great. That's it for investor questions.

Dan Carlson: Great. That's it for investor questions.

Speaker #6: That's it for investor questions

Speaker #3: Jenny, I'll pass it back to you. Operator.

David J. Moss: Jenny, I'll pass it back to you. Operator?

David Moss: Jenny, I'll 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.

Q2 2026 INmune Bio Inc Earnings Call

Request DemoDemo

INmune Bio

Earnings