Filing Date Form TypeDescription   
   
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2021-01-048-K/A[Amend] Current report, items 1.01, 3.03, 5.03, and 9.01 Acc-no: 0001213900-21-000217 (34 Act)  Size: 556 KB
2020-12-308-A12BRegistration of securities [Section 12(b)]Acc-no: 0001213900-20-045474 (34 Act)  Size: 59 KB
2020-12-308-KCurrent report, items 1.01, 3.03, 5.03, and 9.01 Acc-no: 0001213900-20-045464 (34 Act)  Size: 601 KB
2020-12-308-KCurrent report, items 8.01 and 9.01 Acc-no: 0001213900-20-045454 (34 Act)  Size: 48 KB
2020-11-128-KCurrent report, items 8.01 and 9.01 Acc-no: 0001213900-20-036253 (34 Act)  Size: 16 MB
2020-11-098-KCurrent report, items 8.01 and 9.01 Acc-no: 0001213900-20-035894 (34 Act)  Size: 188 KB
2020-11-068-KCurrent report, items 2.02 and 9.01 Acc-no: 0001213900-20-035449 (34 Act)  Size: 110 KB
2020-11-0510-QQuarterly report [Sections 13 or 15(d)]Acc-no: 0001213900-20-035280 (34 Act)  Size: 3 MB
2020-10-278-KCurrent report, items 8.01 and 9.01 Acc-no: 0001213900-20-033364 (34 Act)  Size: 3 MB
2020-10-068-KCurrent report, items 8.01 and 9.01 Acc-no: 0001213900-20-030205 (34 Act)  Size: 31 KB
2020-10-018-KCurrent report, item 5.07 Acc-no: 0001213900-20-029548 (34 Act)  Size: 24 KB
2020-09-298-KCurrent report, items 8.01 and 9.01 Acc-no: 0001213900-20-028780 (34 Act)  Size: 8 MB
2020-09-248-KCurrent report, items 8.01 and 9.01 Acc-no: 0001213900-20-028229 (34 Act)  Size: 33 KB


INmune Bio, Inc. to Host Key Opinion Leader Webinar on Thursday, January 21 at 8 AM ET
01/13/2021 1:00 PM

Webinar to review expanded biomarker data from the company’s Phase 1b clinical trial of XPro1595 targeting neuroinflammation in patients with Alzheimer’s diseaseLA JOLLA, Calif, Jan. 13, 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 company will host a Key Opinion Leader (KOL) webinar on Thursday, January 21, from 8:00 AM – 9:00 AM Eastern Time. The webinar will present new biomarker data from the company’s Phase 1b trial of its lead clinical candidate, XPro1595, in patients with Alzheimer’s disease (AD) and biomarkers of inflammation. The primary goal of this 12 week trial is to demonstrate that XPro1595 decreases neuroinflammation. The Company will present expanded biomarker results in patients treated with XPro1595 for at least 12 weeks.  “We previously reported that XPro1595 decreased neuroinflammation in AD patients as measured by white matter free water (WMFW), a novel biomarker of inflammation that can be measured non-invasively by MRI,” stated CJ Barnum PhD, Head of Neurosciences at INmune Bio. “Consistent with our approach to study a small number of patients intensively in early phase studies, this updated data set will report on additional measures that support our primary goal of reducing neuroinflammation and address some of the exploratory biomarkers that relate to neurodegenerative disease.”Webinar participants include: * RJ Tesi, M.D., co-founder and Chief Executive Officer of INmune Bio. * Dr. CJ Barnum, Ph.D., Head of Neuroscience at INmune Bio. * Dr. Judith Jaeger Ph.D., President and Principal Scientist of CognitionMetrics, LLC. Dr. Jaeger is a cognitive neuropsychologist and internationally recognized expert in assessing cognitive endpoints. * Dr. Malú Gámez Tansey, Ph.D., Director, Center for Translational Research in Neurodegenerative Disease, Medical College of the University of Florida. Dr. Malu Tansey is an internationally recognized expert in neuroinflammation and neurodegenerative disease, including AD. Of note, Malu is an inventor of XPro’s DN-TNF technology and has been studying the drug’s effects on neuroinflammation for over 20 years.RJ Tesi, M.D., co-founder and CEO of INmune Bio, stated: “We look forward to presenting updated data from this important trial with XPro1595.  Our goal is to give investors and clinical experts the information they need to understand the role of XPro1595 in treating neuroinflammation in patients with AD.” KOL Discussion Call InformationTo participate in this event, you must register in advance. Please click on the link below.  After registering, you will receive a confirmation email containing information about joining the webinar.To register and access the live webinar click hereDate: January 21, 2021 Time: 8:00 AM Eastern TimeAbout XPro1595XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that 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 Alzheimer’s 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 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. To learn more, please visit www.inmunebio.com.Information about Forward-Looking StatementsClinical 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.comInvestor Contact: Chuck Padala LifeSci Advisors (646) 627-8390 chuck@lifesciadvisors.comMedia Contact: Meredith Sosulski, Ph.D. LifeSci Communications (929) 469-3851 msosulski@lifescicomms.com

Do Hedge Funds Love Inmune Bio Inc. (INMB)?
11/27/2020 3:59 PM

Although the masses and most of the financial media blame hedge funds for their exorbitant fee structure and disappointing performance, these investors have proved to have great stock picking abilities over the years (that’s why their assets under management continue to swell). We believe hedge fund sentiment should serve as a crucial tool of an […]

Bexion Pharmaceuticals Announces the Addition of Dr. Raymond J. Tesi to Board of Directors
11/17/2020 3:33 PM

Bexion Pharmaceuticals, Inc. announced today that it has added RJ. Tesi, M.D. to its Board of Directors.

INmune Bio, Inc. Announces First Patient Dosed in Phase 2 Trial of Quellor™ for Pulmonary Complications in COVID-19 Patients
11/09/2020 12:00 PM

LA JOLLA, Calif, Nov. 09, 2020 (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 has been dosed in its Phase 2 clinical trial evaluating Quellor™ for the treatment of pulmonary complications from COVID-19. Quellor™ is a selective soluble Tumor Necrosis Factor (sTNF) inhibitor designed to potentially prevent the progression of immune mediated pulmonary complications resulting from SARS-CoV-2 viral infection.“Clinical evidence over the last several months has shown that while infection with COVID-19 virus makes people sick, it’s the uncontrollable immune response and subsequent cytokine storm that is responsible for their admission to a hospital,” stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “By neutralizing TNF, the master inflammatory cytokine of the cytokine storm with Quellor, we believe Quellor™ can blunt the symptoms of this dysregulated immune response.  This US based clinical trial expands both our geographic and therapeutic footprint with our DN-TNF platform.”The dosing of the first patient took place at UofL Health – Jewish Hospital, Louisville, KY. As the largest academic health system in Kentucky, UofL Health is committed to increasing regional access to leading edge treatments and therapies.The double-blind, randomized, placebo-controlled Phase 2 clinical trial (NCT04370236) will enroll 366 COVID-19 high risk patients in two equal sized cohorts: standard of care (SOC), which may include remdesivir, and SOC plus Quellor™ given as a 1mg/kg subcutaneous injection on admission to the hospital. A second dose of Quellor™ may be given a week later if the patient remains hospitalized. High risk patients include the elderly, patients with diabetes, cardiovascular disease, obesity, African American or Hispanic ethnicity.  The primary study endpoint is the need for mechanical ventilation during the 28 days following admission to the hospital, including CPAP, BiPAP or intubation. Secondary endpoints include transfer to the ICU, new onset neurologic, cardiovascular or thromboembolic disease, development of renal failure or death. The first 100 patients randomized into the study will provide proof-of-concept and inform a “go/no go” decision by the Data Safety Monitoring Board (DSMB). If the DSMB recommends that the trial continue, the remaining 266 patients will be enrolled.About Quellor™Quellor™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is different from currently existing non-selective TNF inhibitors. Quellor™ neutralizes soluble TNF (sTNF) using a novel dominant-negative biology that importantly does not affect trans-membrane TNF (tmTNF) or TNF receptors. Currently approved TNF inhibitors block both sTNF and tmTNF. Quellor™ could have beneficial effects in patients with immune mediated complications from COVID-19 by decreasing inflammation and inflammatory immune complications such as endothelial cell activation, a potentially important cause of COVID-19-related coagulopathy which is increasingly blamed for end-organ dysfunction in lungs, kidneys, heart and brain. By targeting only sTNF, Quellor™ does not cause immunosuppression that is typical of most anti-cytokine therapies including currently approved anti-TNF and anti-IL-6 therapies. This may be an advantage when treating patients with a life-threatening viral infection.About UofL HealthUofL Health is a fully integrated regional academic health system with five hospitals, four medical centers, nearly 200 physician practice locations, more than 700 providers, the Frazier Rehab Institute and James Graham Brown Cancer Center. With more than 12,000 team members – physicians, surgeons, nurses, pharmacists and other highly skilled health care professionals, UofL Health is focused on one mission—one purpose—delivering patient-centered care to each and every patient—each and every day.About UofL Health – Jewish Hospital Jewish Hospital, part of UofL Health, is an internationally renowned, high-tech tertiary referral center, developing leading-edge advancements in hand and microsurgery, heart and lung care, orthopedics and sports medicine, neuroscience, organ transplantation and outpatient care. The hospital is the site of the world’s first successful hand transplant and AbioCor® implantable replacement heart procedures, in addition to the first trial of adult cardiac stem cells in chronic heart failure. Jewish Hospital continues to be recognized for its specialized heart care procedures, including the implantation of ventricular assist devices (VAD), and transcatheter aortic valve replacement (TAVR). The UofL Health – Trager Transplant Center is in a select group of hospitals nationwide that perform heart, lung, liver, kidney, pancreas and hand transplantation. The center also includes a Pancreas Disease Center, a GI Motility Clinic, and Advanced Heart Failure and Ventricular Assist Device programs.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 (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. To learn more, please visit www.inmunebio.com.Information about Forward-Looking StatementsClinical 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 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.comMedia Contact: Meredith Sosulski, Ph.D. LifeSci Communications (929) 469-3851 msosulski@lifescicomms.com

INmune Bio, Inc. Announces Third Quarter Results and Provides Business Update
11/05/2020 9:00 PM

Company to host conference call today, November 5, at 4:30pm ETLA JOLLA, Calif., Nov. 05, 2020 (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 third quarter ended September 30, 2020 and provided a business update. “Since our second quarter update, we have made progress with our neuroinflammation franchise. First, we reported positive Phase 1b data in July demonstrating that XPro1595 decreased neuroinflammation by more than 40% in the arcuate fasciculus, a white matter pathway important for learning and memory in Alzheimer’s patients. More recently, we announced receipt of an NIH Small Business Innovation Research Grant of up to $2.9 million to support a Phase 2 study of XPro1595 in treatment resistant depression patients, or TRD,” stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “We believe that TRD represents an important expansion of our neuroinflammation program, and we are working hard to initiate Phase 2 trials in Alzheimer’s and TRD next year.”“In addition, we continue to advance our other programs across both our DN-TNF and INKmune platforms. In DN-TNF, we have opened a Phase II clinical trial using Quellor to treat patients hospitalized from complications of COVID-19. In 2021, assuming the clinical landscape has not changed, and the pandemic is controlled, we will initiate planning for the Phase II trials of LIVNate in NASH and INB03 in cancer. We are also poised to advance our INKmune programs in ovarian cancer and high-risk MDS as well. Overall, we are pleased with our progress in the third quarter and year-to-date,” concluded Dr. Tesi.Q3 2020 and Recent Corporate HighlightsDN-TNF Platform Highlights: * Announced interim Phase Ib data demonstrating that over a 12-week period, XPro1595 decreased neuroinflammation by 40.6% in the arcuate fasciculus, a white matter pathway important for learning and memory in patients with Alzheimer’s disease. The 13 July KOL webinar discussing the data can be found by clicking here. * Awarded a National Institutes of Health (NIH) Small Business Innovation Research Grant of up to $2.9 million to support a phase 2 study of XPro1595 in patients with treatment resistant depression (TRD). The study, entitled, “Effects of the Next Generation TNF Inhibitor (XPro1595) on Inflammation-related Deficits in Reward Circuitry and Motivation in Depression,” will be conducted at two sites in the U.S. – Emory University School of Medicine in Atlanta and University of Alabama in Birmingham. * Hosted a Key Opinion Leader (KOL) webinar on the topic of treatment resistant depression. The webinar discussed the role of neuroinflammation in TRD and featured presentations by two highly-regarded thought leaders in the field: Charles Raison, M.D., professor in the department of psychiatry at the University of Wisconsin at Madison, and John E. Schneider, Ph.D., chief executive officer and principal of Avalon Health Economics. A replay of the webinar can be found by clicking here. * Announced FDA acceptance of an Investigational New Drug (IND) application to initiate a Phase 2 clinical trial evaluating Quellor™, a selective soluble tumor necrosis factor (sTNF) inhibitor, for the treatment of immune mediated complications in COVID-19 patients. * Announced that the European Patent Office has granted a patent covering XPro1595 and its peripheral administration for treating Alzheimer’s disease and other diseases of the CNS. The patent expires in 2033. NK Priming Platform Highlights: * Announced that the US Patent and Trademark Office has issued a patent covering a method for treating cancer using INKmune™, the company’s natural killer (NK) cell priming technology. The patent expires in 2036. Financial Highlights: * Closed a $25 million public offering of common stock, including full exercise of the underwriters’ over-allotment option, resulting in net proceeds of approximately $23.1 million. Upcoming Milestones:2020: * Enroll first patient in Phase II Quellor™ program, targeting COVID-19 patients with immune mediated complications from COVID-19. 2021: * Report additional data on Phase 1b XPro1595 in Alzheimer’s Disease in January 2021. The company will host a KOL call in tandem with the announcement. * XPro1595 Phase 2 program for treatment resistant depression. * XPro1595 Phase 2 program for Alzheimer's disease in patients with neuro-inflammation. The company plans additional clinical trials after the COVID-19 pandemic has been controlled. The exact timing of these trials cannot be predicted at this time: * INKmune Phase 1 program for ovarian cancer. * INKmune Phase 1 program for high-risk MDS. * LIVNate Phase 2 program for NASH. * INB03 Phase 2 program for MUC4 expressing cancer.Financial Results for the Third Quarter Ended September 30, 2020:Net loss attributable to common stockholders for the third quarter ended September 30, 2020 was approximately $4.7 million, compared to approximately $3.1 million for the quarter ended September 30, 2019.Research and development expense totaled approximately $2.4 million for the third quarter ended September 30, 2020, compared to approximately $1.2 million during the third quarter ended September 30, 2019.General and administrative expense was approximately $2.5 million for the quarter ended September 30, 2020, compared to approximately $1.9 million during the third quarter ended September 30, 2019.As of September 30, 2020, the Company had cash and cash equivalents of approximately $24.3 million and no debt. September 30 cash and cash equivalents reflects a public offering of common stock which the company completed in July which raised net proceeds of approximately $23.1 million.As of November 5, 2020, the Company had approximately 13.4 million common shares outstanding.Earnings Call InformationTo participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.Date: Thursday, November 5, 2020 Time: 4:30 PM Eastern Time Participant Dial-in: 800-909-4145 Participant Dial-in (international): 415-226-5358A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through November 12 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 21970461.About XPro1595XPro1595 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 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 StatementsClinical 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.comInvestor Contact: Chuck Padala LifeSci Advisors (646) 627-8390 chuck@lifesciadvisors.comMedia Contact: Meredith Sosulski, Ph.D. LifeSci Communications (929) 469-3851 msosulski@lifescicomms.com The following table summarizes our results of operations for the periods indicated:INMUNE BIO, INC. CONSOLIDATED BALANCE SHEETS (Unaudited)  September 30, 2020  December 31, 2019          ASSETS         CURRENT ASSETS         Cash and cash equivalents $24,311,153  $6,995,525  Research and development tax incentive receivable  1,465,377   568,139  Other tax receivable  143,657   77,225  Prepaid expenses  216,871   97,623  Prepaid expenses – related party  -   26,266            TOTAL CURRENT ASSETS  26,137,058   7,764,778            Operating lease – right of use asset – related party  165,388   191,543  Acquired in-process research and development intangible assets  16,514,000   16,514,000            TOTAL ASSETS $42,816,446  $24,470,321            LIABILITIES AND STOCKHOLDERS’ EQUITY                   CURRENT LIABILITIES         Accounts payable and accrued liabilities $1,191,086  $401,989  Accounts payable and accrued liabilities – related parties  9,132   290,102  Deferred liabilities  253,709   -  Operating lease, current liability – related party  20,183   8,288  TOTAL CURRENT LIABILITIES  1,474,110   700,379            Long-term operating lease liability – related party  136,043   160,164  TOTAL LIABILITIES  1,610,153   860,543            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, 13,447,948 and 10,770,948 shares issued and outstanding, respectively  13,448   10,771  Additional paid-in capital  71,351,634   44,833,703  Common stock issuable  50,000   50,000  Accumulated other comprehensive loss  (37,735)  (8,515) Accumulated deficit  (30,171,054)  (21,276,181) TOTAL STOCKHOLDERS’ EQUITY  41,206,293   23,609,778            TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $42,816,446  $24,470,321  INMUNE BIO, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)  For the Three Months Ended September 30,  For the Nine Months Ended September 30,    2020  2019  2020  2019  REVENUE $-  $-  $-  $-                    OPERATING EXPENSES                 General and administrative  2,456,266   1,916,200   4,960,106   4,550,306  Research and development  2,362,880   1,167,986   4,058,710   2,415,390  Waiver of common stock issuable  -   -   -   (1,542,000) Total operating expenses  4,819,146   3,084,186   9,018,816   5,423,696                    LOSS FROM OPERATIONS  (4,819,146)  (3,084,186)  (9,018,816)  (5,423,696)                   OTHER INCOME  102,484   17,220   123,943   63,602                    NET LOSS $(4,716,662) $(3,066,966) $(8,894,873) $(5,360,094)                   Net loss per common share – basic and diluted $(0.36) $(0.28) $(0.77) $(0.53)                   Weighted average common shares outstanding - basic and diluted  12,926,539   10,762,473   11,496,753   10,105,675                    COMPREHENSIVE LOSS                 Net loss $(4,716,662) $(3,066,966) $(8,894,873) $(5,360,094) Other comprehensive loss on foreign currency translation  (47,861)  (35,542)  (29,220)  (61,278)                   Total comprehensive loss $(4,764,523) $(3,102,508) $(8,924,093) $(5,421,372) INMUNE BIO, INC.CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)  For the Nine Months Ended September 30,    2020  2019  CASH FLOWS FROM OPERATING ACTIVITIES:         Net loss $(8,894,873) $(5,360,094) Adjustments to reconcile net loss to net cash used in operating activities:         Stock-based compensation  2,409,066   2,924,091  Waiver of common stock issuable  -   (1,542,000) Changes in operating assets and liabilities:         Research and development tax incentive receivable  (897,238)  (361,769) Other tax receivable  (66,432)  (68,460) Joint development cost receivable  -   17,989  Prepaid expenses  (119,248)  (106,478) Prepaid expenses – related party  26,266   (118,602) Accounts payable and accrued liabilities  789,097   (215,983) Accounts payable and accrued liabilities – related parties  (65,209)  (108,434) Deferred liabilities  253,709   -  Operating lease liability – related party  13,929   (11,546) Net cash used in operating activities  (6,550,933)  (4,951,286)           CASH FLOWS FROM FINANCING ACTIVITIES:         Net proceeds from sale of common stock  24,907,781   12,209,021  Purchase of common stock  (1,012,000)  -  Net cash provided by financing activities  23,895,781   12,209,021            Impact on cash from foreign currency translation  (29,220)  (61,278)           NET INCREASE IN CASH  17,315,628   7,196,457            CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD  6,995,525   186,204            CASH AND CASH EQUIVALENTS AT END OF PERIOD $24,311,153  $7,382,661            SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION:         Cash paid for income taxes $-  $-  Cash paid for interest expense $-  $-            NONCASH INVESTING AND FINANCING ACTIVITIES:         Capital contribution $215,761  $-  Cashless exercise of warrants $2  $-  Issuance of warrants to placement agents $-  $247,452  Issuance of common stock issuable $-  $3,084,000

INmune Bio, Inc. to Report Third Quarter 2020 Financial Results and Provide a Corporate Update on Thursday, November 5
10/29/2020 12:30 PM

Management to host conference call at 4:30 pm ET on that dayLA JOLLA, Calif, Oct. 29, 2020 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company” or “INmune”), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, today announced that it will host a conference call on Thursday, November 5, 2020 at 4:30 PM Eastern Time to discuss results for its third quarter ended September 30, 2020 and to provide a corporate update.Conference Call InformationTo participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Third Quarter Conference Call when reaching an operator.Date: November 5, 2020 Time: 4:30 PM Eastern Time Participant Dial-in: 800-909-4145 Participant Dial-in (international): 415-226-5358A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through November 12 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 21970461.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 in clinical trials to determine if it can help 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 The Company’s 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.comInvestor Contact: Chuck Padala LifeSci Advisors, LLC (917) 741-7792 Chuck@lifesciadvisors.com

Do Insiders Own Lots Of Shares In INmune Bio, Inc. (NASDAQ:INMB)?
10/26/2020 11:51 AM

A look at the shareholders of INmune Bio, Inc. (NASDAQ:INMB) can tell us which group is most powerful. Insiders often...

INmune Bio, Inc. Presents Preliminary Phase I Data at 21st International Conference on Alzheimer’s Drug Discovery
10/05/2020 1:00 PM

LA JOLLA, Calif., Oct. 05, 2020 (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 CJ Barnum PhD, Head of Neurosciences will present data from the ongoing biomarker directed Phase Ib study of neuroinflammation in patients with Alzheimer’s disease.  The talk entitled, Phase 1b Study in AD Patients with Neuroinflammation​, will be given today at 11:20AM ET as part of this year’s virtual 21st International Conference on Alzheimer’s Drug Discovery meeting.  The trial continues to enroll patients and additional data on the Phase Ib study will be presented in the near future. “Neuroinflammation plays an important role in the pathophysiology of Alzheimer’s disease,” said CJ Barnum PhD, Head of Neurosciences at INmune Bio.  “The preliminary data, albeit in a small number of patients, demonstrate that XPro1595, when given via subcutaneous injection, decreases neuroinflammation in the arcuate fasciculus, a white matter tract critical for the proper use of language.”  White Matter Free Water (WMFW) is a novel biomarker of inflammation measured using non-invasive neuroimaging by functional MRI.  Increases in WMFW biomarkers occur in Alzheimer’s patients as the disease progresses.  Preliminary data in the first 6 patients showed that treatment with XPro1595 decreased WMFW on average by 40% in the arcuate fasciculus (range 20-50%).  XPro1595 is a selective inhibitor of soluble Tumor Necrosis Factor (sTNF), a key inflammatory cytokine implicated in causing neuroinflammation in patients with neurologic disease including treatment resistant depression, Alzheimer’s disease and potentially other neurodegenerative diseases.  This Phase Ib multi-center, open label study will enroll patients with biomarkers of inflammation that have Alzheimer’s disease.  Patients are treated for 12 weeks.  Multiple measures of neuroinflammation are studied including biomarkers of inflammation in blood, CSF, and breath as well as neuroimaging biomarkers studied by MRI and behavioral end-points commonly seen in AD patients such as depression, aggression, apathy, anhedonia and sleep disorders. Measures of cognitive decline are measured as part of the trial, but due to the small size, short duration and variable disease status at time of enrollment, changes in cognitive function are not primary endpoints. “The use of novel biomarkers is a hallmark of INmune Bio’s clinical development programs,” said RJ Tesi MD, CEO of INmune Bio. “The use of biomarkers may allow smarter, smaller and faster clinical trials in patients with neurodegenerative diseases.” About XPro1595XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that 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 Alzheimer’s 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 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 (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 StatementsThe Company’s 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.comInvestor Contact: Chuck Padala LifeSci Advisors (646) 627-8390 chuck@lifesciadvisors.com  Media Contact: Meredith Sosulski, Ph.D. LifeSci Communications (929) 469-3851 msosulski@lifescicomms.com

INmune Bio, Inc. to Host Key Opinion Leader Webinar on Treatment Resistant Depression on Tuesday, September 29
09/23/2020 10:00 AM

LA JOLLA, Calif., Sept. 23, 2020 (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 the Company will be hosting a Key Opinion Leader (KOL) webinar on the topic of treatment resistant depression (TRD) at 1:00p.m. ET on Tuesday, September 29, 2020. The webinar will discuss the role of neuroinflammation in TRD and will feature presentations by two highly-regarded thought leaders in the field: Charles Raison, M.D., professor in the department of psychiatry at the University of Wisconsin at Madison, and John E. Schneider, Ph.D., chief executive officer and principal of Avalon Health Economics. INmune Bio has recently been awarded a $2.9 million Small Business Innovation Research (SBIR) grant (which will be disbursed to the Company in stages) from the National Institutes of Health (NIH) to support a Phase 2 study of its lead clinical candidate, XPro1595, in patients with TRD.   Management will provide an overview of the trial design.To register and access the live webinar click here or use this link: https://zoom.us/webinar/register/WN_jBsKRkSGSF2VThn6hh5V0ADate: September 29, 2020Time: 1:00 PM Eastern TimeCharles Raison, M.D., professor in the department of psychiatry at the University of Wisconsin at MadisonDr. Raison is the Mary Sue and Mike Shannon Chair for Healthy Minds, Children & Families in the School of Human Ecology and a Professor in the Department of Psychiatry at the University of Wisconsin – Madison. Dr. Raison received his medical degree from Washington University in St Louis, Missouri, where he was elected to Alpha Omega Alpha and won the Missouri State Medical Association Award. He completed residency training at the UCLA Neuropsychiatric Institute and Hospital in Los Angeles. In addition to his medical training, Dr. Raison obtained his Masters of English from the University of Denver.Dr. Raison has written and published more than 100 scientific papers as well 20 review papers and editorials. Chapters he has written have been featured in more than 30 books, and he has written two books, most recently “The New Mind-Body Science of Depression” published by WW Norton in 2017. Dr. Raison’s publications have been cited more than 14,000 times, with three publications having more than 1,000 citations. His H-index is 44. The recipient of several teaching awards, Dr. Raison has received research funding from the National Institute of Mental Health, National Center for Complementary and Alternative Medicine, and the Centers for Disease Control and Prevention. His visionary work focuses on the treatment of depression in response to illness and stress, translating neurobiological findings into novel interventions. In addition to his activities at University of Wisconsin-Madison, Dr. Raison is the mental health expert for CNN.com.John E. Schneider, Ph.D., chief executive officer and founder of Avalon Health EconomicsJohn E. Schneider is the CEO and founder of Avalon Health Economics. Dr. Schneider was one of the founding partners of the Health Economics Consulting Group, LLC (HECG), which formed in 2004. HECG merged with the UK-based Oxford Outcomes in 2009, and from 2009-2013 Dr. Schneider served as Senior Director of the U.S. health economics operations of Oxford Outcomes, which also included facilitating integration between Oxford Outcomes and ICON plc in 2011. He started Avalon Health Economics in 2013 by bringing together the consulting practices of several industry and academic colleagues, building on what he started with HECG in 2004. Prior to starting HECG, Dr. Schneider was on the faculty in the Department of Health Management and Policy and the Department of Economics at the University of Iowa. His Ph.D. is in health services and policy analysis from the University of California, Berkeley, with a concentration in health economics. He has more than 25 years of experience studying economic and organizational aspects of the health care industry, including professional appointments at the Center for Health Economics Research (Waltham, MA; now part of RTI International), and the California Association of Health Plans (Sacramento, CA). Dr. Schneider has also served as a consultant to managed care organizations, state health departments, trade associations, medical device manufacturers, large pharmaceutical companies, and others. Some of his research has been published in Medical Care Research and Review, International Journal of Healthcare Finance and Economics, Tobacco Control, Health Economics Review, Health Affairs, Inquiry, Health Services Research, Review of Industrial Organization, International Journal of Technology Assessment in Health Care, American Journal of Medical Science, Prevention Science, and Health Care Financing Review. He is co-author of The Business of Health (AEI Press, 2006).Disclaimer: Research reported in this publication was supported by the National Institute of Mental Health of the National Institutes of Health under Award Number R44MH125480. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.About XPro1595XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that 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 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. To learn more, please visit www.inmunebio.com.Forward Looking StatementsClinical 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.comInvestor Contact: Chuck Padala LifeSci Advisors (646) 627-8390 chuck@lifesciadvisors.comMedia Contact: Meredith Sosulski, Ph.D. LifeSci Communications (929) 469-3851 msosulski@lifescicomms.com

INmune Bio, Inc. Awarded $2.9 Million NIH Small Business Innovation Research Grant to Support Phase 2 Study of XPro1595 in Patients with Treatment Resistant Depression
09/16/2020 11:00 AM

100 patient blinded, randomized, biomarker-directed Phase 2 study will use neuroimaging technology to study the complex biology of treatment resistant diseaseStudy supports INmune Bio’s approach to treating inflammation as a common mechanism in neurologic diseaseAccompanying Key Opinion Leader webinar to be hosted on September 29, 2020 to discuss the role of neuroinflammation in treatment resistant depressionLA JOLLA, Calif., Sept. 16, 2020 (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 it has received a $2.9 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH), of which (subject to the terms of the grant), the Company will receive $739,739 this year, $1,210,682 next year with the balance to be received in 2022. The grant will support a Phase 2 study of XPro1595 in patients with treatment resistant depression. The study, entitled, “Effects of the Next Generation TNF Inhibitor (XPro1595) on Inflammation-related Deficits in Reward Circuitry and Motivation in Depression,” will be conducted at two sites in the U.S. – Emory University School of Medicine in Atlanta and University of Alabama in Birmingham. “Treatment resistant depression is a major problem affecting more than seven million patients in the U.S. alone,” said CJ Barnum Ph.D., head of neurosciences at INmune Bio. “This grant is a collaboration with two highly-regarded thought leaders in this difficult to treat condition: Professor Andrew H. Miller, M.D. and Associate Professor Jennifer Felger, Ph.D., both at Emory University. Dr. Miller is the foremost expert in neuroinflammation and depression and published the first study demonstrating that anti-TNF treatment could improve depressive symptoms in patients that had high levels of the inflammatory marker C-Reactive Protein (CRP), a biomarker that will be used to select patients in our study. In addition, Dr. Felger discovered that the connection between two regions of the brain, vital for feelings of pleasure and motivation, are lost in depressed patients with inflammation. Our hypothesis is that XPro1595 will restore this connectivity.”XPro1595 is a selective inhibitor of soluble Tumor Necrosis Factor (sTNF), a key inflammatory cytokine implicated in causing neuroinflammation in patients with neurologic disease including treatment resistant depression, Alzheimer’s disease, and other neurodegenerative diseases. This Phase 2 multi-center, blinded, randomized study will enroll patients with treatment resistant depression that have biomarkers of inflammation and anhedonia (inability to feel pleasure). Neuroimaging biomarkers will be used to measure response to XPro1595. Patients will be studied with functional MRI to determine if functional connectivity in reward-related brain circuitry can be improved by reversing neuroinflammation, and if this translates into improvements in the clinical symptoms of anhedonia and motivation.  RJ Tesi M.D., chief executive officer of INmune Bio, added, “This award reinforces one of INmune Bio’s fundamental drug development tenets – by targeting the underlying biology, you can target a diverse group of diseases caused by inflammation. Through this Phase 2 study, we will evaluate the potential utility of XPro1595 to treat the biology of neuroinflammation which, we believe, will have a beneficial effect on patients suffering from treatment resistant depression. We recently presented preliminary data demonstrating that XPro1595 decreased neuroinflammation in Alzheimer’s disease, and we believe these findings provide strong rationale for study in this high-need neuroinflammatory indication as well.”The company will also host a Key Opinion Leader (KOL) webinar at 1 p.m. ET on Tuesday, September 29, 2020 to provide additional information about the role of neuroinflammation in treatment resistant depression. This webinar will feature presentations by Charles Raison, M.D., professor in the Department of Psychiatry at the University of Wisconsin at Madison, and John E. Schneider, Ph.D., chief executive officer and principal of Avalon Health Economics. Further details will be provided in the near future.Disclaimer: Research reported in this publication was supported by the National Institute of Mental Health of the National Institutes of Health under Award Number R44MH125480. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.About Treatment Resistant Depression Major Depressive Disorder (MDD) is highly prevalent, difficult to treat, and is one of the most disabling of all medical conditions worldwide. According to the National Institutes of Health, an estimated 20 million adults, experience MDD each year. At least one third (approximately seven million patients) are considered to have Treatment Resistant Depression (TRD), which is defined as persistence of depressive symptoms after the patient has failed to respond to two previous lines of conventional anti-depressant treatment of adequate dose and duration. Patients with TRD incur the highest direct and indirect medical costs among those with MDD. These costs increase with the severity of TRD. Treatment-resistant patients are twice as likely to be hospitalized, and their cost of hospitalization is more than six times the mean total cost for depressed patients who are not treatment resistant. account for nearly $64 billion of total costs.1,2About XPro1595XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that 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 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 (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 StatementsClinical 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.1 Mrazek, et al. A Review of the Clinical, Economic, and Societal Burden of Treatment- Resistant Depression: 1996–2013. Psychiatr Serv. 2014;65(8):977-987.2 Ionescu, et al. Pharmacological approaches to the challenge of treatment-resistant depression. Dialogues Clin Neurosci. 2015;17(2):111-126.INmune Bio Contact:  David Moss, CFO (858) 964-3720 dmoss@INmuneBio.comInvestor Contact: Chuck Padala LifeSci Advisors (646) 627-8390 chuck@lifesciadvisors.comMedia Contact: Meredith Sosulski, Ph.D. LifeSci Communications (929) 469-3851 msosulski@lifescicomms.com* * *

INmune Bio, Inc. to Participate in Oppenheimer’s Fall Healthcare Life Science & Med Tech Virtual Investor Summit, on September 23, 2020.
09/14/2020 11:00 AM

LA JOLLA, Calif., Sept. 14, 2020 (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 management will participate in Oppenheimer’s Fall Healthcare Life Science & Med Tech Virtual Investor Summit, on September 23, 2020.Management will be available for virtual one-on-one meetings during the conference. To schedule a meeting with management, please contact your conference representative or James@HaydenIR.com. 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.Information about Forward-Looking StatementsClinical 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 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.comInvestor Contact: James Carbonara (646) 755-7412 James@haydenir.com

INmune Bio, Inc. Announces Issuance of Patent from U.S. Patent & Trademark Office Covering INKmune™ Therapy
09/03/2020 1:00 PM

LA JOLLA, Calif., Sept. 03, 2020 (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 United States Patent & Trademark Office (USPTO) has issued US Pat. No. 10,758,567 B2, titled “IN VIVO PRIMING OF NATURAL KILLER CELLS,” which covers a method for treating cancer using INKmune™, a natural killer (NK) cell priming technology. The patent expires in 2036.“We are excited to receive the first patent related to our INKmune program,” said Joshua Schoonover, Associate General Counsel of INmune Bio. “This patent covers a unique method of priming a patient’s own NK cells within the body to enhance NK cell-mediated tumor lysis, thereby treating cancer.”INKmune co-inventor and INmune Bio’s Chief Executive Officer, RJ Tesi, M.D., added, “Natural killer cells are an important component of the immune system. INKmune enhances a patient’s own NK cells to more efficiently recognize and combat the proliferation of cancer. The issuance of this patent encourages further investments as we continue to develop INKmune in the clinic.”About INKmuneTMINKmuneTM is a experimental biologic delivery system that allows for the delivery of essential priming signals to patients’ resting NK cells. INKmune is delivered by a simple IV infusion. Once in the patient’s system, INKmune comes in contact with resting NK cells. The interaction converts resting NK cells to “primed NK cells” (PiNKs) similar to an “on-off” switch. PiNKs then remain primed until they contact and kill cancer cells. 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.Information about Forward-Looking StatementsClinical 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 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.comMedia Contact: Meredith Sosulski, Ph.D. LifeSci Communications (929) 469-3851 msosulski@lifescicomms.com

INmune Bio, Inc. Announces FDA Acceptance of IND Application to Evaluate Quellor™ in a Blinded Randomized Phase 2 Trial for Immune Mediated Complications in COVID-19 Patients
09/01/2020 1:00 PM

Trial to evaluate the efficacy of Quellor™ to blunt the cytokine storm and decrease the catastrophic complications of COVID-19 infection.LA JOLLA, Sept. 01, 2020 (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 U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application to initiate a Phase 2 clinical trial evaluating Quellor™, a selective soluble tumor necrosis factor (sTNF) inhibitor, for the treatment of immune mediated complications in COVID-19 patients. “There is compelling evidence that TNF plays an outsized role in the pathology caused by the cytokine storm,” stated RJ Tesi, MD, Chief Executive Officer of INmune Bio. “We can now move to the clinic to determine if neutralizing soluble TNF, the master cytokine of the cytokine storm, will blunt the effects of this dysregulated innate immune response to the SARS-CoV-2 virus without immunosuppressing the patient.”    The blinded randomized Phase 2 clinical trial (NCT04370236) will enroll 366 COVID-19 patients in two equal sized cohorts: standard of care (SOC), which may include remdesivir or SOC plus Quellor™ given as a 1mg/kg subcutaneous injection on admission to the hospital. A second dose of Quellor™ may be given a week later if the patient remains hospitalized. The primary study endpoint is the need for mechanical ventilation during the 28 days following admission to the hospital, including CPAP, BiPAP or intubation. Secondary endpoints include transfer to the ICU, new onset neurologic, cardiovascular or thromboembolic disease, development of renal failure or death. The first 100 patients randomized into the study will provide proof-of-concept and inform a “go/no go” decision by the Data Safety Monitoring Board (DSMB). If the DSMB recommends that the trial continue, the remaining 266 patients will be enrolled. About Quellor™Quellor™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is different from currently existing non-selective TNF inhibitors. Quellor ™ neutralizes soluble TNF (sTNF) using a novel dominant-negative biology that importantly does not affect trans-membrane TNF (tmTNF) or TNF receptors. Currently approved TNF inhibitors block both sTNF and tmTNF. Quellor™ could have beneficial effects in patients with immune mediated complications from COVID-19 by decreasing inflammation and inflammatory immune complications such as endothelial cell activation, a potentially important cause of COVID-19-related coagulopathy which is increasingly blamed for end-organ dysfunction in lungs, kidneys, heart and brain. By targeting only sTNF, Quellor™ does not cause immunosuppression that is typical of most anti-cytokine therapies including currently approved anti-TNF and anti-IL-6 therapies. This may be an advantage when treating patients with a life-threatening viral infection. 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.Information about Forward-Looking StatementsClinical 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 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.comInvestor Contact: Chuck Padala LifeSci Advisors (646) 627-8390 chuck@lifesciadvisors.comMedia Contact: Meredith Sosulski, Ph.D. LifeSci Communications (929) 469-3851 msosulski@lifescicomms.com

European Patent Granted Covering INmune Bio’s XPro1595
08/13/2020 1:00 PM

LA JOLLA, Calif., Aug. 13, 2020 (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 European Patent Office (EPO) has granted EP Pat. No. 2,892,547, titled “A DOMINANT NEGATIVE TNF-ALPHA INHIBITOR FOR USE IN TREATING NEUROLOGICAL DISORDERS OF THE CNS,” which covers XPro1595 and its peripheral administration for treating Alzheimer’s Disease and other diseases of the CNS. The patent, which is set to expire in 2033, is owned by Xencor, Inc. and is licensed exclusively to INmune Bio.“This patent memorializes the discovery that XPro1595 crosses the blood brain barrier in therapeutically-significant quantities, which provides for a less invasive peripheral administration of the drug, as opposed to central administration to the CNS,” said Joshua Schoonover, Assoc. General Counsel of INmune Bio. “As a result of this patented discovery, XPro1595 is distinguished as a next generation anti-TNF therapeutic having properties that are advantageous for treating neuroinflammation.”INmune Bio CEO, RJ Tesi, added: “People from  many countries in Europe suffer from a high prevalence of Alzheimer’s disease and other neurologic diseases associated with neuroinflammation. Data from our Phase I trial in AD suggests Xpro1595 may attenuate neuroinflammation in parts of the brain that are clinically relevant. This European patent gives us the freedom to further develop XPro1595 for the treatment of neurologic diseases in this important market.”This patent comes shortly after INmune Bio’s announcement of data showing Xpro1595 decreases neuroinflammation in patients with Alzheimer’s disease.  The data shows XPro1595 reduced neuroinflammation by an average of 40.6% in the arcuate fasciculus, a brain fiber pathway important for language and short-term memory.  A Key Opinion Leader Webinar on XPro1595 Phase 1b interim data of neuroinflammation in patient with Alzheimer’s Disease can be seen by clicking here.About XPro1595XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that 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 beneficial effects in patients with Alzheimer’s 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 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.Information about Forward-Looking StatementsClinical 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 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.comInvestor Contact: James Carbonara (646) 755-7412 James@haydenir.com

INmune Bio, Inc. Announces Second Quarter 2020 Results and Provides Business Update
08/05/2020 8:01 PM

The company will host an earnings call: Today, August 5 at 4:30 PM ETLA JOLLA, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), an immunology company 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, 2020 and is providing a business update. INmune Bio will hold a conference call today at 4:30 PM Eastern Time. To participate in the call, please dial 415-226-5355 five minutes before the scheduled time. “In the second quarter, and year to date, INmune Bio continued to progress forward with both of our clinical platforms,” stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “We announced interim Phase Ib data demonstrating that our Alzheimer’s Disease candidate, XPro1595, can reduce neuroinflammation. Our progress with XPro1595 supports our overall strategy to create platforms of therapeutics, based on reducing inflammation by targeting the innate immune system to fight disease.  We are planning a number of programs employing this approach in NASH, MUC4 expressing HER2+ cancer, ALS and complications of cytokine storm caused by COVID-19.  With the Natural Killer Priming platform, we anticipate INKmune™ Phase I in high-risk MDS to start the second half of this year.”Q2 2020 and Recent Corporate Highlights DN-TNF Platform Highlights: * Announced interim Phase Ib data demonstrating that XPro1595 decreases neuroinflammation in patients with Alzheimer's Disease - XPro1595 reduced neuroinflammation by 40.6% in a white matter tract important for learning and memory. * Announced combination therapy of Lapatinib with INB03 may be used to overcome resistance to trastuzumab in women with MUC4+/HER2+ breast cancer.  This work was presented at the AACR 2020 by Dr. Roxana Schillaci and may form the basis for a Phase II program in patients with MUC4 expressing HER2+ cancer. * Initiated a clinical program to test targeting soluble TNF (Quellor™), one of the key components of the cytokine storm, using our TNF Inhibitor (DN-TNF) Platform to prevent complications of COVID-19 infection.  * Frontiers in Oncology published an invited entitled Tumor Necrosis Factor α Blockade: an Opportunity to Tackle Breast Cancer by Prof. Roxana Schillaci, a leader in the field of TNF in cancer.NK Priming Platform Highlights: * Received regulatory clearance from UK MHRA to initiate a Phase I Trial of INKmune in patients with high-risk MDS - study will be the first-in man trial for INKmune – a novel therapy to prime the patient’s own NK cells to attack their cancer. * Announced allowance of U.S. Patent covering method for treating cancer by in-vivo priming of natural killer cells. * Received notice of allowance in counterpart patent in Australia covering method for treating cancer by in-vivo priming of natural killer cells. * Announced publication of a review article: Killers at the crossroads: The use of innate immune cells in adoptive cellular therapy of cancer in the journal Stem Cells Translational Medicine by Prof. Mark Lowdell, Co-Founder and CSO of INmune Bio, Inc.  The article reviews the potential of harnessing cells of the innate immune system to treat cancer.Financial Highlights: * Closed a $25 million gross proceeds public offering of common stock, including full exercise of Underwriters’ Over-Allotment Option resulting in net proceeds of approximately $23.1 million after deducting underwriting discounts and commissions and other offering expenses payable by the Company.Upcoming Milestones: * Report additional data on Phase 1b XPro1595 in Alzheimer’s Disease in 2H 2020. * Enroll first patient in Phase II Quellor™ program, targeting COVID-19 patients with immune mediated complications from COVID-19. * Enroll first patient in Phase I INKmune™ in High Risk MDS cancer, expected 2H20. * Enroll first patient in Phase I INKmune™ in Ovarian cancer, expected mid-2021.Financial Results for the Second Quarter Ended June 30, 2020:Net loss attributable to common stockholders for the second quarter ended June 30, 2020 was $2.1 million, compared to $0.4 million for the quarter ended June 30, 2019.Research and development expense totaled approximately $0.9 million for the second quarter ended June 30, 2020, compared to approximately $0.6 million during the second quarter ended June 30, 2019.General and administrative expense was approximately $1.2 million for the quarter ended June 30, 2020, compared to approximately $1.3 million during the second quarter ended June 30, 2019.As of June 30, 2020, the Company had cash and cash equivalents of approximately $4.8 million with no debt. Subsequent to the quarter end, INmune Bio closed a $25 million gross proceeds public offering of common stock resulting in net proceeds of approximately $23.1 million after deducting underwriting discounts and commissions and other offering expenses payable by the Company.As of August 5, 2020, the Company had approximately 13.4 million common shares outstanding.Earnings Call InformationTo participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.Date: August 5, 2020 Time: 4:30 PM Eastern Time Participant Dial-in: 1-415-226-5355About 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.Information about Forward-Looking StatementsClinical 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 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.comInvestor Contact:  James Carbonara (646) 755-7412 James@haydenir.comThe following table summarizes our results of operations for the periods indicated:INMUNE BIO, INC. CONSOLIDATED BALANCE SHEETS (Unaudited) June 30, 2020  December 31, 2019         ASSETS        CURRENT ASSETS        Cash and cash equivalents$4,816,561  $6,995,525  Research and development tax credit receivable 1,044,843   568,139  Other tax receivable 155,000   77,225  Prepaid expenses 342,492   97,623  Prepaid expenses – related party -   26,266           TOTAL CURRENT ASSETS 6,358,896   7,764,778           Operating lease – right of use asset – related party 174,649   191,543  Acquired in-process research and development intangible assets 16,514,000   16,514,000           TOTAL ASSETS$23,047,545  $24,470,321           LIABILITIES AND STOCKHOLDERS’ EQUITY                 CURRENT LIABILITIES        Accounts payable and accrued liabilities$624,893  $401,989  Accounts payable and accrued liabilities – related parties 223,562   290,102  Deferred liabilities 361,842   -  Operating lease, current liability – related party 6,950   8,288  TOTAL CURRENT LIABILITIES 1,217,247   700,379           Long-term operating lease liability – related party 145,430   160,164  TOTAL LIABILITIES 1,362,677   860,543           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, 10,897,630 and 10,770,948 shares issued and outstanding, respectively 10,898   10,771  Additional paid-in capital 47,068,236   44,833,703  Common stock issuable 50,000   50,000  Accumulated other comprehensive loss 10,126   (8,515) Accumulated deficit (25,454,392)  (21,276,181) TOTAL STOCKHOLDERS' EQUITY 21,684,868   23,609,778           TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY$23,047,545  $24,470,321            INMUNE BIO, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) For the Three Months Ended June 30,  For the Six Months Ended June 30,   2020  2019  2020  2019  REVENUE$-  $-  $-  $-                   OPERATING EXPENSES                General and administrative 1,204,366   1,335,727   2,503,840   2,634,106  Research and development 903,043   634,696   1,695,830   1,247,404  Waiver of common stock issuable -   (1,542,000)  -   (1,542,000) Total operating expenses 2,107,409   428,423   4,199,670   2,339,510                   LOSS FROM OPERATIONS (2,107,409)  (428,423)  (4,199,670)  (2,339.510)                  OTHER (EXPENSE) INCOME (395)  36,340   21,459   46,382                   NET LOSS$(2,107,804) $(392,083) $(4,178,211) $(2,293,128)                  Net loss per common share – basic and diluted$(0.20) $(0.04) $(0.39) $(0.23)                  Weighted average common shares outstanding - basic and diluted 10,800,708   10,150,810   10,774,004   9,771,833                   COMPREHENSIVE LOSS                Net loss$(2,107,804) $(392,083) $(4,178,211) $(2,293,128) Other comprehensive gain (loss) – gain (loss) on foreign currency translation 39,378   (25,014)  18,641   (25,736)                  Total comprehensive loss$(2,068,426) $(417,097) $(4,159,570) $(2,318,864)                  INMUNE BIO, INC.CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) For the Six Months Ended June 30,   2020  2019  CASH FLOWS FROM OPERATING ACTIVITIES:        Net loss$(4,178,211) $(2,293,128) Adjustments to reconcile net loss to net cash used in operating activities:        Stock-based compensation 1,363,410   1,949,395  Waiver of common stock issuable -   (1,542,000) Changes in operating assets and liabilities:        Research and development tax credit receivable (476,704)  (251,472) Other tax receivable (77,775)  (67,315) Joint development cost receivable -   (31,340) Prepaid expenses (244,869)  (184,472) Prepaid expenses – related party 26,266   (244,882) Accounts payable and accrued liabilities 222,904   (115,004) Accounts payable and accrued liabilities – related parties 149,221   (200,654) Deferred liabilities 361,842   -  Operating lease liability – related party 822   (24,653) Net cash used in operating activities (2,853,094)  (3,005,525)          CASH FLOWS FROM FINANCING ACTIVITIES:        Net proceeds from sale of common stock 1,667,489   12,209,021  Purchase of common stock (1,012,000)  -  Net cash provided by financing activities 655,489   12,209,021           Impact on cash from foreign currency translation 18,641   (25,736)          NET (DECREASE) INCREASE IN CASH (2,178,964)  9,177,760           CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 6,995,525   186,204           CASH AND CASH EQUIVALENTS AT END OF PERIOD$4,816,561  $9,363,964           SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION:        Cash paid for income taxes$-  $-  Cash paid for interest expense$-  $-           NONCASH INVESTING AND FINANCING ACTIVITIES:        Capital contribution$215,761  $-  Issuance of warrants to placement agents$-  $247,452  Issuance of common stock issuable$-  $3,084,000

INmune Bio, Inc to Present at the BTIG Virtual Biotechnology Conference 2020
08/03/2020 11:00 AM

LA JOLLA, Calif, Aug. 03, 2020 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company” or “INmune”), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, today announced that management will be presenting a corporate overview at the BTIG Virtual Biotechnology Conference being held August 10-11, 2020 and will also be available for 1x1 meetings. To schedule a meeting, please contact your BTIG representative or email James@HaydenIR.com.       INmune Bio Fireside Chat Details:BTIG Virtual Biotechnology Conference 2020 Date:  Monday, August 10, 2020 Presentation Time:  1:00 - 1:25 PM ETAbout 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 StatementsClinical 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, including without limitation statements regarding the completion and timing of the offering and the amount and use of proceeds therefrom, 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.comInvestor Contact: James Carbonara, Hayden IR (646) 755-7412 james@haydenir.com

INmune Bio, Inc. Schedules Conference Call to Report 2020 Second Quarter Financial Results
07/31/2020 11:00 AM

LA JOLLA, Calif, July 31, 2020 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company” or “INmune”), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, today announced that it will host a conference call on August 5, 2020 at 4:30 PM Eastern Time to discuss results for its second quarter ended June 30, 2020. Conference Call InformationTo participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Second Quarter Conference Call when reaching an operator.Date: August 5, 2020 Time: 4:30 PM Eastern Time Participant Dial-in: 212-231-2931A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available for approximately one week by calling 412-317-6671 and entering PIN no. 21967252.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 StatementsClinical 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, including without limitation statements regarding the completion and timing of the offering and the amount and use of proceeds therefrom, 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.comInvestor Contact: James Carbonara, Hayden IR (646) 755-7412 james@haydenir.com

INmune Bio, Inc. Featured on Fox News (VIDEO): STNF and Cytokine Storm
07/27/2020 11:00 AM

LA JOLLA, Calif, July 27, 2020 (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 was featured on a Fox Business News segment. Fox Business News reports: “INmune Bio CEO, President and acting CMO Dr. Raymond Tesi, M.D. talks about INmune Bio's proposed phase two human trials of possible treatment of coronavirus patients using an anti-inflammatory drug and addresses the effort for lower drug costs.” To watch the full interview, please visit the link below: https://video.foxbusiness.com/v/6174850319001/?playlist_id=937116503001sp=show-clipsAbout 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 StatementsClinical 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.comInvestor Contact: James Carbonara (646) 755-7412 James@haydenir.com

Correction: INmune Bio, Inc. Announces Closing of $25 Million Public Offering of Common Stock Including Full Exercise of Underwriters’ Over-Allotment Option
07/20/2020 8:57 PM

LA JOLLA, Calif., July 20, 2020 -- In a release issued under the same headline on Monday, July 20th by INmune Bio, Inc. (NASDAQ: INMB) was incorrectly reported with below.

INmune Bio, Inc. Announces Closing of $25 Million Public Offering of Common Stock Including Full Exercise of Underwriters’ Over-Allotment Option
07/20/2020 5:07 PM

LA JOLLA, Calif., July 20, 2020 -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company” or “INmune”), a clinical-stage immunology company focused on developing treatments that.