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INmune Bio, Inc. (INMB)

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Previous Close8.47
Open8.49
Bid8.25 x 1800
Ask8.85 x 800
Day's Range8.30 - 8.84
52 Week Range2.20 - 24.42
Volume66,365
Avg. Volume160,016
Market Cap113.904M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)-0.99
Earnings DateNov 05, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est20.00
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  • Bexion Pharmaceuticals Announces the Addition of Dr. Raymond J. Tesi to Board of Directors
    PR Newswire

    Bexion Pharmaceuticals Announces the Addition of Dr. Raymond J. Tesi to Board of Directors

    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
    GlobeNewswire

    INmune Bio, Inc. Announces First Patient Dosed in Phase 2 Trial of Quellor™ for Pulmonary Complications in COVID-19 Patients

    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
    GlobeNewswire

    INmune Bio, Inc. Announces Third Quarter Results and Provides Business Update

    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