On November 6, 2020 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, reported its financial results for the third quarter ended September 30, 2020 and provided a business update (Press release, INmune Bio, NOV 6, 2020, View Source [SID1234570157]).

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"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 Highlights

DN-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.

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About XPro1595

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