On August 5, 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 second quarter ended June 30, 2020 and is providing a business update (Press release, INmune Bio, AUG 5, 2020, View Source [SID1234563115]). 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.

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"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 (Free AACR Whitepaper) 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.

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