INMB INmune Bio Inc.

18.34
+0.27  (+1%)
Previous Close 18.07
Open 17.9
52 Week Low 7.28
52 Week High 30.37
Market Cap $327,216,631
Shares 17,841,692
Float 11,801,924
Enterprise Value $297,369,374
Volume 434,355
Av. Daily Volume 670,034
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Upcoming Catalysts

Drug Stage Catalyst Date
Quellor
Immune mediated complications from COVID-19
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
XPro (pegipanermin)
Alzheimer’s disease
Phase 1b
Phase 1b
Phase 2 trial planned with data due 2H 2023.
INKmune
Myelodysplastic syndromes (MDS)
Phase 1
Phase 1
Phase 1 initial biomarker data from 1 patient showed successful response August 25 2021.
XPro1595
Treatment resistant depression
Phase 2
Phase 2
Phase 2 trial to be initiated 2H 2021.
INB03
MUC4 expressing cancer
Phase 2
Phase 2
Phase 2 trial planned.
LIVNate
Nonalcoholic steatohepatitis (NASH)
Phase 2
Phase 2
Phase 2 trial planned.
INKmune
Ovarian cancer
Phase 1
Phase 1
Phase 1 trial planned.

Latest News

  1. Company to present additional phase 1b data during webinar on Sept 7th, 2021 at 4:30 pm EST.

    Boca Raton, FL, Sept. 01, 2021 (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 announced that XPro™ (pegipanermin), the Company's selective DN-TNF inhibitor candidate for the treatment of Alzheimer's disease (AD), treatment resistant depression, and other neurological diseases where neuroinflammation is implicated, has been found to decrease multiple species of Phospho Tau (pTau) and improve neuroimaging biomarkers of myelination in patients with AD.

    These biomarker data are from the…

    Company to present additional phase 1b data during webinar on Sept 7th, 2021 at 4:30 pm EST.

    Boca Raton, FL, Sept. 01, 2021 (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 announced that XPro™ (pegipanermin), the Company's selective DN-TNF inhibitor candidate for the treatment of Alzheimer's disease (AD), treatment resistant depression, and other neurological diseases where neuroinflammation is implicated, has been found to decrease multiple species of Phospho Tau (pTau) and improve neuroimaging biomarkers of myelination in patients with AD.

    These biomarker data are from the analysis of the Company's recently concluded Phase 1 study of XPro™ in Alzheimer's patients. AD patients treated with 1.0 mg/kg of XPro™ once a week for three months had a 46% reduction is CSF pT217 (p<0.0001) and a lesser reduction in pT181 (p<0.01). While pT181 is recognized as the standard CSF biomarker of AD, recent studies suggest that pT217 has higher discriminative accuracy for AD and a stronger correlation with amyloidosis and cognitive decline.

    "CSF pT217 appears to be the more sensitive tau biomarker of neurodegeneration in patients with AD, and our data show that controlling neuroinflammation decreases pT217," said CJ Barnum, PhD, Head of Neurosciences for INmune Bio. "Tau pathology has been associated with decreased white matter integrity in AD and we believe these data are consistent with our biomarkers for the measurement of white matter pathology in patients with AD. White matter pathology starts early, the changes are measurable, and appear to be reversed following treatment with XProTM."

    The Company also reported improvement in white matter MRI metrics, including a 16% improvement in radial diffusivity, a biomarker of remyelination. These data add to previously reported improvements in apparent fiber density (axonal integrity), and free water (neuroinflammation). In each metric, improvements continued throughout the 12-month extension trial (the last time point assessed).

    "The data from this Phase I trial show that XPro™ decreases biomarkers of neuroinflammation and nerve cell death while improving biomarkers of neurorepair in patients with AD," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "Now we can add improvements in neuroimaging biomarkers of remyelination to the beneficial effects of XProTM in these patients.  In our upcoming Phase 2 trial, we hope to demonstrate that when XProTM decreases neuroinflammation and neurodegeneration, improves axonal quality and promotes remyelination, there will be a measurable benefit on the patient's cognitive function."

    The Company plans to start enrolling a blinded, randomized Phase 2 trial in patients with mild AD by the end of 2021. The six-month trial will enroll 200 patients at centers across North America and Australia. Patients will receive 1mg/kg of XProTM weekly by subcutaneous injection. The primary endpoint is EMACC (Early AD/Mild Cognitive Impairment Alzheimer's Cognitive Composite), a sensitive measure of cognitive function.

    INmune Bio management will host an investor webinar to review these findings and additional phase 1b data in greater detail. Details of the webinar can be found below:

    Investor Webinar Details

    Date:                          September 7, 2021

    Time:                          4:30 pm ET

    Registration Link:      (Click Here) or:        https://us06web.zoom.us/webinar/register/WN_IlMwrkPGRa63319QM91YFg

    About Xpro™ (pegipanermin)

    Xpro™ (formerly Xpro1595) is a next-generation inhibitor of tumor necrosis factor (TNF) that uses a dominant-negative TNF technology that is very different from approved TNF inhibitors that block the effects of both soluble and trans-membrane TNF. Xpro™ neutralizes soluble TNF, without affecting trans-membrane TNF or TNF receptors. Xpro™ could have substantial beneficial effects in patients with Alzheimer's and other neurodegenerative diseases by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio's website.

    About 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 two product platforms. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is currently being developed for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer's and Treatment Resistant Depression (Xpro™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the patient's NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio's product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation with components of the innate immune system. To learn more, please visit www.inmunebio.com.

    Information about Forward-Looking Statements

    Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.  Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, Quellor™, Xpro™, LIVNate™, and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved and there cannot be any assurance that they will be approved or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K, the Company's Quarterly Reports on Form 10-Q and the Company's Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

    INmune Bio Contact:

    David Moss, CFO

    (858) 964-3720

    DMoss@INmuneBio.com

    Investor Contact:

    Chuck Padala

    LifeSci Advisors

    (646) 627-8390

    chuck@lifesciadvisors.com



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  2. First positive clinical confirmation of in vivo NK response, mirroring in vitro data

    Boca Raton, FL, Aug. 25, 2021 (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, announced today that the first patient who received INKmune™ as a potential treatment for high-risk myelodysplastic syndrome (MDS) has successfully shown the NK activation and functional differentiation predicted by previously published in vitro experiments.

    NK cells need multiple activating signals to progress from a resting state to the triggering of cytolysis and cytokine secretion. INmune Bio has studied these pathways…

    First positive clinical confirmation of in vivo NK response, mirroring in vitro data

    Boca Raton, FL, Aug. 25, 2021 (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, announced today that the first patient who received INKmune™ as a potential treatment for high-risk myelodysplastic syndrome (MDS) has successfully shown the NK activation and functional differentiation predicted by previously published in vitro experiments.

    NK cells need multiple activating signals to progress from a resting state to the triggering of cytolysis and cytokine secretion. INmune Bio has studied these pathways extensively and demonstrated that binding of NK cells with INKmune™ provides multiple activating signals and drives resting NK to the phenotype of memory-like NK (mlNK) cells with enhanced cancer-killing function. The company believes that this is the first ever successful generation of mlNK cells in patients.

    "The INmune Bio team has been developing the concept of tumor cell-primed NK cells since 2004 with the creation of the first pharmaceutical-grade tumor line for NK priming a critical first step in testing whether these primed, memory-like NK cells could be generated in vivo." said Dr. Lowdell PhD, chief scientific officer of INmune Bio. "In the lab, INKmune™ binds to multiple NK ligands and initiates the activation of over 3,000 genes associated with function, trafficking, proliferation, and survival to form memory-like NK cells, which have superior cancer killing function. In our hands, no single cytokine has such broad physiological effects on NK cells compared to INKmune-primed NK cells, and this has inspired us to refer to INKmune™ as a pseudokine."

    Preliminary data from the first patient shows that formation of mlNK cells can be achieved in vivo and without toxicity. INKmune™ was delivered in three doses on days one, eight and 15. INKmune™ therapy cause proliferation of NK cells with a doubling of the number of peripheral blood NK cell numbers on day 8. Over 50% of the expanded NK cells had an activated profile (CD69+/CD25+) on days eight and 15 and increased to over 70% by day 29. More than 80% of the activated NK cells expressed markers associated with a memory-like NK cell (CD57++, NKG2D+, NKG2A-ve, NKp46-ve). In vitro, the INKmune™ activated NK cells were better at killing cancer cells than the patient's own NK cells prior to treatment, with an 82% increase in lysis of K562 leukemia cells and a 47% increase in lysis of NK-resistant RAJI lymphoma cell tumor cells as early as day eight. Despite this high level of activated NK cells and tumor killing, the patient showed no symptoms of Cytokine Release Syndrome (CRS).

    "We are always cautious of single patient data but seeing these significant changes in peripheral blood NK cell populations in a patient treated at the lowest dose of INKmune™ is encouraging and identical to what we observed in pre-clinical studies," added Dr. Lowdell.

    "Data from this patient demonstrates that INKmune™ can produce memory-like NK cells in patients," said RJ Tesi, M.D., chief executive officer of INmune Bio. "These biomarker data demonstrate that, even in a heavily pre-treated patient, INKmune™ can cause proliferation of the patients NK cells and convert them into the type of NK cells that are superior at killing cancer cells."

    At least nine additional patients with high-risk MDS will be enrolled in the ongoing Phase I trial.   A video overview of the INKmune™ platform can be found by clicking here.

    About INKmune

    INKmuneTM is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals akin to treatment with at least three cytokines in combination. INKmune™ is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer.

    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 two product platforms. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is currently being developed for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer's and Treatment Resistant Depression (XPro1595), and NASH (LIVNate™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the patient's NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio's product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation with components of the innate immune system. To learn more, please visit www.inmunebio.com.

    Information about Forward-Looking Statements

    Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.  Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, Quellor™, XPro1595, LIVNate™, and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved and there cannot be any assurance that they will be approved or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K, the Company's Quarterly Reports on Form 10-Q and the Company's Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

    INmune Bio Contact:

    David Moss, CFO

    (858) 964-3720

    DMoss@INmuneBio.com

    Investor Contact:

    Chuck Padala

    LifeSci Advisors

    (646) 627-8390

    chuck@lifesciadvisors.com



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  3. BOCA RATON, Florida, Aug. 10, 2021 (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 announced that Raymond J. Tesi, MD, President and CEO, will present at the Canaccord Genuity 41st Annual Growth Conference being held August 10 – 12.

    Canaccord Genuity 41st Annual Growth Conference
    Presentation Date: Wednesday, August 11, 2021
    Presentation Time: 9:00 AM Eastern Time
    Webcast: https://wsw.com/webcast/canaccord60/inmb/2433112

    Please contact your representative at Canaccord Genuity to schedule a virtual one-on-one meeting with INmune Bio during the respective conference.

    BOCA RATON, Florida, Aug. 10, 2021 (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 announced that Raymond J. Tesi, MD, President and CEO, will present at the Canaccord Genuity 41st Annual Growth Conference being held August 10 – 12.

    Canaccord Genuity 41st Annual Growth Conference

    Presentation Date: Wednesday, August 11, 2021

    Presentation Time: 9:00 AM Eastern Time

    Webcast: https://wsw.com/webcast/canaccord60/inmb/2433112

    Please contact your representative at Canaccord Genuity to schedule a virtual one-on-one meeting with INmune Bio during the respective conference.

    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 two product platforms.  The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is currently being developed for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer's (XPro595), and NASH (LIVNate™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the patient's NK cells to eliminate minimal residual disease in patients with cancer.  INmune Bio's product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation. To learn more, please visit www.inmunebio.com.

    Forward Looking Statements

    Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595, LIVNate, Quellor™ and INKmune are still in clinical trials or preparing to start clinical trials and have not been approved and there cannot be any assurance that they will be approved or that any specific results will be achieved. Our two platforms are beginning clinical trials and there cannot be any assurance of the success of these trials. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K, the Company's Quarterly Reports on Form 10-Q and the Company's Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

    INmune Bio Contact: 

    David Moss, CFO (858) 964-3720

    DMoss@INmuneBio.com

    Investor Contact:

    Chuck Padala

    LifeSci Advisors

    (646) 627-8390

    chuck@lifesciadvisors.com

    Media Contact:

    Michael Tattory

    LifeSci Communications

    609-802-6265

    mtattory@lifescicomms.com



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  4. LA JOLLA, Calif., Aug. 05, 2021 (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 announced that Raymond J. Tesi, MD, President and CEO, will present at the BTIG Virtual Biotechnology Conference being held August 9 – 10.

    BTIG Virtual Biotechnology Conference
    Presentation Date: Monday, August 9, 2021
    Presentation Time: 1:00 PM Eastern Time
    Information:  Click Here

    Please contact your representative at BTIG to schedule a virtual one-on-one meeting with INmune Bio during the respective conference.

    About INmune Bio, Inc.
    INmune Bio, Inc. is a publicly traded (NASDAQ:INMB), clinical-stage…

    LA JOLLA, Calif., Aug. 05, 2021 (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 announced that Raymond J. Tesi, MD, President and CEO, will present at the BTIG Virtual Biotechnology Conference being held August 9 – 10.

    BTIG Virtual Biotechnology Conference

    Presentation Date: Monday, August 9, 2021

    Presentation Time: 1:00 PM Eastern Time

    Information:  Click Here

    Please contact your representative at BTIG to schedule a virtual one-on-one meeting with INmune Bio during the respective conference.

    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 two product platforms.  The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is currently being developed for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer's (XPro595), and NASH (LIVNate™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the patient's NK cells to eliminate minimal residual disease in patients with cancer.  INmune Bio's product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation. To learn more, please visit www.inmunebio.com.

    Forward Looking Statements

    Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595, LIVNate, Quellor™ and INKmune are still in clinical trials or preparing to start clinical trials and have not been approved and there cannot be any assurance that they will be approved or that any specific results will be achieved. Our two platforms are beginning clinical trials and there cannot be any assurance of the success of these trials. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K, the Company's Quarterly Reports on Form 10-Q and the Company's Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

    INmune Bio Contact: 

    David Moss, CFO (858) 964-3720

    DMoss@INmuneBio.com

    Investor Contact:

    Chuck Padala

    LifeSci Advisors

    (646) 627-8390

    chuck@lifesciadvisors.com

    Media Contact:

    Michael Tattory

    LifeSci Communications

    609-802-6265

    mtattory@lifescicomms.com



    Primary Logo

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  5. BOCA RATON, Fla., Aug. 04, 2021 (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 reported its financial results for the second quarter ended June 30, 2021 and provided a business update.

    "We continue our planning and setup for a Phase 2 clinical trial of our lead candidate, XPRO™ (Xpro1595™), in patients with mild Alzheimer's disease, which we plan to initiate by year-end," stated RJ Tesi, M.D. "We have already demonstrated that XPRO™ can reduce neuroinflammation and decreases biomarkers of neurodegeneration and improve synaptic function. If successful in Phase 2, we believe XPRO™…

    BOCA RATON, Fla., Aug. 04, 2021 (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 reported its financial results for the second quarter ended June 30, 2021 and provided a business update.

    "We continue our planning and setup for a Phase 2 clinical trial of our lead candidate, XPRO™ (Xpro1595™), in patients with mild Alzheimer's disease, which we plan to initiate by year-end," stated RJ Tesi, M.D. "We have already demonstrated that XPRO™ can reduce neuroinflammation and decreases biomarkers of neurodegeneration and improve synaptic function. If successful in Phase 2, we believe XPRO™ has the potential to be among the most significant advancements in the treatment of Alzheimer's Disease (AD) and other neurodegenerative diseases in many years."

    Dr. Tesi continued, "At the Alzheimer's Association International Conference last week, we introduced a new biomarker - Apparent Fiber Density (AFD), a measure of axonal integrity measured by MRI. XPRO™ increases AFD in patients receiving 1mg/kg/week. We believe the novel non-invasive white matter analytics of white matter free water and apparent fiber density will be very useful in the development of XPRO™ in AD, Treatment Resistant Depression (TRD) and the many other CNS indications we hope to attack in the future."

    "With the completion of a registered direct offering during July 2021 in which the Company raised $36.9 million of net proceeds combined with the Company raising $15.0 million of net proceeds from the sale of common stock through the ATM, also in July 2021, we are well financed to Phase 2 Alzheimer's data and other milestones such as clinical data from INKmune and other developments with our DN-TNF franchise assuming no material delays caused by the pandemic," said David Moss, CFO.

    "Last month, we treated the first patient in the first Phase 1 clinical trial of our NK cell priming platform, INKmune, in high-risk myelodysplastic syndrome (MDS)," stated RJ Tesi, M.D. "We are calling INKmune a pseudokine because, in vitro, it converts the resting NK cells into memory-like NK cells that can kill cancer cells as well or better than NK cells treated cytokines such as IL-12, IL-15 and IL-18 alone or in combination."

    "Our preliminary data from the first patient treated with INKmune support the safety of this approach and give the first confirmation that the in vitro effects of INKmune on NK cells does translate to patients," said Professor Mark Lowdell, PhD. "I am particularly excited to see NK cells expanding in our first patient, treated at the lowest dose, which are activated and express cytotoxicity receptors for tumor cells.  We are planning to open a second site for the MDS trial in the UK shortly and to open a second Phase 1 trial, in ovarian cancer in the coming months; although both are subject to ongoing COVID-related restrictions."

    Q2 2021 and Recent Corporate Highlights INKmune Platform Highlights:

    • Announced that the first patient has been treated in the company's Phase 1 clinical trial of its Natural Killer (NK) cell priming platform, INKmune, as a potential treatment for high-risk myelodysplastic syndrome (MDS). Biomarker data is expected before the end of the year.



      • The Company has made available a video overview of its INKmune platform. Interested parties can view the video here.

    DN-TNF Platform Highlights:

    • Phase 2 trial design of Xpro™ for the treatment of AD will enroll 168 patients in a 2:1 randomized, placebo-controlled trial with cognitive measurements as a primary endpoint.



    • Phase 1b XPRO™ data in AD to be discussed via Webinar the week of September 6th.



    • Presented a poster on XPRO™ at the Alzheimer's Association International Conference 2021 (AAIC).



    • Data from the Phase 2 trial of Quellor in hospitalized COVID-19 patients suffering from pulmonary complications should be delivered to the Data Safety Monitoring Board this month.

    Financial Highlights:

    • Subsequent to the end of the second quarter, raised $36.9 million of net proceeds through a registered direct offering and raised $15.0 million of net proceeds through sales of our common stock through ATM, sufficient to fund the company at least through topline data from its planned Phase 2 study of Xpro™.



    • Entered into a $15 million credit facility with Silicon Valley Bank to partially fund the buyout of an option held by Xencor resulting from INmune's in-licensing of Xpro™ in October 2017. The retirement of the Xencor option eliminates an estimated 2.1 million shares of potential future common stock dilution upon exercise of the option.

    Upcoming Milestones:

    • Report on Phase 1b data for XPRO™ Alzheimer's disease trial.
    • Initiate XPRO™ Phase 2 program for Alzheimer's disease in patients with neuro-inflammation by year-end 2021.



    • Initiate XPRO™ Phase 2 program for treatment resistant depression, funded in part by a $2.9 million NIH grant, by year-end 2021.



    • Report on first group of patients treated with Quellor™ as part of Phase 2 trial in patients with COVID 19 infection and respiratory compromise.



    • Report on biomarkers from the INKmune™ high-risk MDS Phase 1 trial before year end.

    Financial Results for the Second Quarter Ended June 30, 2021:

    Net loss attributable to common stockholders for the quarter ended June 30, 2021 was approximately $6.7 million, compared to approximately $2.1 million for the quarter ended June 30, 2020.

    Research and development expense totaled approximately $4.5 million for the quarter ended June 30, 2021, compared to approximately $0.9 million during the quarter ended June 30, 2020.

    General and administrative expense was approximately $2.1 million for the quarter ended June 30, 2021, compared to approximately $1.2 million during the quarter ended June 30, 2020.

    As of June 30, 2021, the Company had cash and cash equivalents of approximately $39.5 million.

    As of August 4, 2021, the Company had approximately 17.7 million common shares outstanding.

    Earnings Call Information

    To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

    Date: Wednesday, August 4, 2021

    Time: 4:30 PM Eastern Time

    Participant Dial-in: 877-407-0784

    Participant Dial-in (international): 201-689-8560

    A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 11, 2021 by dialing 11-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13721921.

    About XPro™

    XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently existing TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro1595 could have substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio's website.

    About INKmune

    INKmune™ is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer.

    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 two product platforms that are both in clinical trials. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is in clinical trial to determine if it can treat for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer's and treatment resistant depression (XPro595), and NASH (LIVNate™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the patient's NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio's product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation. To learn more, please visit www.inmunebio.com.

    Forward Looking Statements

    Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595, LIVNate, Quellor™ and INKmune are still in clinical trials or preparing to start clinical trials and have not been approved and there cannot be any assurance that they will be approved or that any specific results will be achieved. Our two platforms are beginning clinical trials and there cannot be any assurance of the success of these trials. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K, the Company's Quarterly Reports on Form 10-Q and the Company's Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

    INmune Bio Contact:

    David Moss, CFO

    (858) 964-3720

    DMoss@INmuneBio.com

    Investor Contact:

    Chuck Padala

    LifeSci Advisors

    (646) 627-8390



    INMUNE BIO, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except share and per share amounts)

    (Unaudited)

          
     June 30,

    2021
      December 31,

    2020
     
    ASSETS     
    CURRENT ASSETS     
    Cash and cash equivalents$39,520  $21,967 
    Research and development tax credit receivable 3,068   1,686 
    Other tax receivable 51   113 
    Prepaid expenses 1,395   220 
    Prepaid expenses – related party 15   - 
            
    TOTAL CURRENT ASSETS 44,049   23,986 
            
    Operating lease – right of use asset – related party 137   156 
    Acquired in-process research and development intangible assets 16,514   16,514 
            
    TOTAL ASSETS$60,700  $40,656 
            
    LIABILITIES AND STOCKHOLDERS' EQUITY       
            
    CURRENT LIABILITIES       
    Accounts payable and accrued liabilities$2,361  $1,518 
    Accounts payable and accrued liabilities – related parties 9   34 
    Deferred liabilities 583   190 
    Operating lease, current liability – related party 36   34 
    TOTAL CURRENT LIABILITIES 2,989   1,776 
            
    Long-term debt, less debt discount 14,348   - 
    Long-term operating lease liability – related party 106   126 
    Accrued liabilities – long-term 24   - 
    TOTAL LIABILITIES 17,467   1,902 
            
    COMMITMENTS AND CONTINGENCIES       
            
    STOCKHOLDERS' EQUITY       
    Preferred stock, $0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding -   - 
    Common stock, $0.001 par value, 200,000,000 shares authorized, 15,125,171 and 13,481,283 shares issued and outstanding, respectively 15   13 
    Additional paid-in capital 87,854   72,105 
    Accumulated other comprehensive (loss) income (50)  11 
    Accumulated deficit (44,586)  (33,375)
    TOTAL STOCKHOLDERS' EQUITY 43,233   38,754 
            
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY$60,700  $40,656 
            

    INMUNE BIO, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (In thousands, except share and per share amounts)

    (Unaudited)

          
     For the Three

    Months Ended

    June 30,
      For the Six

    Months Ended

    June 30,
     
     2021  2020  2021  2020 
    REVENUE$-  $-  $4  $- 
                    
    OPERATING EXPENSES               
    General and administrative 2,090   1,204   4,151   2,504 
    Research and development 4,464   903   6,955   1,696 
    Total operating expenses 6,554   2,107   11,106   4,200 
                    
    LOSS FROM OPERATIONS (6,554)  (2,107)  (11,102)  (4,200)
                    
    OTHER (EXPENSE) INCOME (101)  (1)  (109)  22 
                    
    NET LOSS$(6,655) $(2,108) $(11,211) $(4,178)
                    
    Net loss per common share – basic and diluted$(0.44) $(0.20) $(0.77) $(0.39)
                    
    Weighted average common shares outstanding - basic and diluted 14,974,953   10,800,708   14,650,608   10,774,004 
                    
    COMPREHENSIVE LOSS               
    Net loss$(6,655) $(2,108) $(11,211) $(4,178)
    Other comprehensive income (loss) - foreign currency translation (62)  39   (61)  18 
                    
    Total comprehensive loss$(6,717) $(2,069) $(11,272) $(4,160)
                    

    INMUNE BIO, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS 

    (In thousands)

    (Unaudited)

       
     For the Six

    Months Ended

    June 30,
     
     2021  2020 
    CASH FLOWS FROM OPERATING ACTIVITIES:     
    Net loss$(11,211) $(4,178)
    Adjustments to reconcile net loss to net cash used in operating activities:       
    Stock-based compensation 1,668   1,363 
    Accretion of debt discount 16   - 
    Changes in operating assets and liabilities:       
    Research and development tax credit receivable (1,382)  (477)
    Other tax receivable 62   (78)
    Prepaid expenses (1,175)  (244)
    Prepaid expenses – related party (15)  26 
    Accounts payable and accrued liabilities 843   223 
    Accounts payable and accrued liabilities – related parties (25)  149 
    Deferred liabilities 393   362 
    Accrued liabilities – long term 24   - 
    Operating lease liability – related party 1   1 
    Net cash used in operating activities (10,801)  (2,853)
            
    CASH FLOWS FROM INVESTING ACTIVITIES:       
    Cash paid to Xencor to settle warrant for acquired research and development intangible assets (15,000)  - 
    Net cash used in investing activities (15,000)  - 
            
    CASH FLOWS FROM FINANCING ACTIVITIES:       
    Net proceeds from the issuance of debt 14,951   - 
    Net proceeds from sale of common stock 28,446   1,667 
    Net proceeds from the exercise of warrants 18   - 
    Purchase of common stock -   (1,012)
    Net cash provided by financing activities 43,415   655 
            
    Impact on cash from foreign currency translation (61)  18 
            
    NET INCREASE (DECREASE) IN CASH 17,553   (2,180)
            
    CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 21,967   6,996 
            
    CASH AND CASH EQUIVALENTS AT END OF PERIOD$39,520  $4,816 


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