On March 12, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the fourth quarter and full year ended December 31, 2019 and is providing a business update (Press release, INmune Bio, MAR 12, 2020, View Source [SID1234555480]).

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The Company will hold a conference call today at 11AM Eastern (U.S.) time. To participate in the live conference call, please dial 1-877-407-2988 five minutes prior to the scheduled conference call time and ask for the, "INmune Bio Conference Call." International callers should dial 1-201-389-0923. Participants can also use this link for instant telephone access to the event.

2019 and Recent Corporate Highlights on the DN-TNF Platform and NK Priming Platform:

·Closed an initial public offering ("IPO") and commenced trading on The Nasdaq Capital Market.
·Added two new independent members to the board of directors; Ed Baracchini former chief business officer of Xencor, Inc. who has negotiated many transactions with pharmaceutical and biotechnology companies and; Marcia Allen, a fortune 500 executive with vast accounting and finance experience.
DN-TNF Platform Highlights:

·Successfully reported Phase I clinical data that INB03 demonstrates safety and efficacy in cancer patients and has announced that the Phase II program will target trastuzumab resistance in women with HER2+ breast cancer using INB03 as part of combination therapy.
·Awarded a $1,000,000 grant from The Alzheimer’s Association allowing INMB to initiate a Phase 1 clinical trial using XPro1595 to treat patients with Alzheimer’s Disease.
·Awarded a $500,000 grant from The ALS Association to complete IND enabling pre-clinical studies with XPro1595 as a therapy for ALS.
·Initiated a program in NASH with LIVNate the third drug development program from the DN-TNF platform, joining DN-TNF platform drug candidates INB03 and XPro1595.

·XPro1595 had 9 articles published in peer review journals by academic collaborators and INB03 was one of 85 abstracts (out of 885) to be given as an oral presentation at SITC (Free SITC Whitepaper)2019.
·United States Patent and Trademark Office (USPTO) has issued Patent No. 15/776,061 on January 28, 2020, titled "CANCER PREVENTION AND THERAPY BY INHIBITING SOLUBLE TUMOR NUCROSIS FACTOR", which covers INmune’s INB03 Program utilizing dominant negative TNF (DN-TNF) technology for treating cancer.
NK Priming Platform Highlights:

·Announced publication of data on INKmune in Peer-Reviewed Journal PLOS ONE. INKmune is a novel NK cell priming platform that signals the patient’s own NK cells to target residual disease of cancer.
·Finalized and validated manufacturing and distributions processes for INKmune to support up-coming clinical trials.
Professor Lowdell, CSO INmune Bio and Professor of Cell Therapy at UCL, London, and creator of the INKmune product said, "2019 has been a landmark year for this product and is the culmination of 20 years’ of bench-to-bedside research. We have published the molecular basis of the mechanism of action in a peer-reviewed journal, developed scaled manufacture adequate for full commercial delivery and validated an efficient and easily delivered cold supply chain for the drug. I am extremely excited about our delivery of patients into two phase I trials this year in high risk MDS cancer and ovarian cancer, two very different clinical applications."

"2019 and year to date, has been a period of substantial progress," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "We completed our first-in-man study of our DN-TNF platform in cancer and have expanded that franchise to include Alzheimer’s Disease and NASH. Additionally, we just announced pre-clinical proof-of-concept studies in ALS. Both our NK cell priming platform and DN-TNF platform continue to generate data in the laboratory and the clinic to allow us to expand the depth and breadth of our pipeline."

Upcoming Milestones:

·Report results of Phase 1 XPro1595 in Alzheimer’s Disease, expected to complete 2H 2020.
·Enroll first patient in Phase II INB03 program, targeting trastuzumab resistant HER2+ breast cancer using INB03 as part of combination therapy, expected mid-2020.
·Enroll first patient in Phase II LIVNate for NASH, expected mid-2020.
·Enroll first patient in Phase I INKmune in High Risk MDS cancer, expected 2H 2020.
·Enroll first patient in Phase I INKmune in Ovarian cancer, expected 2H 2020.

Financial Results for the Fourth Quarter Ended December 31, 2019:

Net loss attributable to common stockholders for the fourth quarter ended December 31, 2019 was $2.3 million, compared to $1.9 million for the quarter ended December 31, 2018.

Research and development expense totaled approximately $0.9 million for the fourth quarter ended December 31, 2019, compared with approximately $1.0 million for the quarter ended December 31, 2018. The decrease in research and development expense was due to the Company recording $0.3 million of contra research and development expense as a result of the receipt of a grant from the Alzheimer’s Association. Excluding the grant, research and development expense increased during the three months ended December 31, 2019 as a result of the further advancement of our drug platforms.

General and administrative expense was approximately $1.5 million in the quarter ended December 31, 2019, compared to approximately $0.9 million in the quarter ended December 31, 2018. The $0.6 million increase in general and administrative expense is largely due to the costs associated with being a public company and due to higher compensation cost (including higher stock-based compensation).

At December 31, 2019, the Company had cash and cash equivalents of approximately $7.0 million with no debt. During the quarter ending December 31, 2019, the Company received $0.4 million of cash proceeds from Australia and $0.4 million of cash proceeds from the United Kingdom pursuant to research and development tax credits.

As of March 10, 2020, the Company had 10.7 million common shares outstanding.