INmune Bio, Inc. Announces Third Quarter 2021 Results and Provides Business Update Announces second Phase 2 trial of XPro in Mild Cognitive Impairment (MCI) in addition to previously announced Phase 2 trial in mild Alzhe

Bio, Inc. Announces Third Quarter 2021 Results and Provides Business Update

second Phase 2 trial of XPro in Mild Cognitive Impairment (MCI) in addition to previously announced Phase 2 trial in mild Alzheimer's

and cash equivalents of $84.5 million on September 30th

to host conference call today, November 3rd, at 4:30pm ET

RATON, Fla., Nov. 03, 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, today reported

its financial results for the third quarter ended September 30, 2021 and provided a business update.

the first patient treated in our Phase I study of INKmune in high-risk myelodysplastic syndrome, INKmune was found to safely

produce cancer killing memory-like NK cells while increasing proliferation and persistence of those NK cells. As expected, the memory-like

NK cells generated in vivo killed NK-resistant cancer cells in vitro," stated RJ Tesi, M.D., Chief Executive Officer

of INmune Bio. "We now have data from Day 73 post first treatment and over 60% of his peripheral blood NK cells remained activated

and highly functional in vitro. We are continuing to screen patients for future enrollment and are in the process of expanding

the number of clinical trial sites in the UK and overseas. Our latest drug stability data allows us to extend the shelf-life to over

12 months and consequently we initiated a manufacturing scale up to secure drug supplies as the program expands."

our Phase I trial of XPro in AD, we have shown that XPro decreases biomarkers of neuroinflammation and neurodegeneration while improving

biomarkers of CNS repair," continued Dr. Tesi. "We hope to demonstrate these effects on cognition in the Phase II mild AD

trial that is on track to initiate later this year."

of the XPro Phase I AD trial and Phase II mild AD trial design will be presented in five presentations at the upcoming Clinical Trials

in Alzheimer's Disease (CTAD) annual meeting in Boston, being held November 9th through 12th.

Company today announced a second Phase II program in patients with Mild Cognitive Impairment (MCI). This Phase II study will be a three-month,

double-blind, randomized, placebo-controlled trial in 90 patients with MCI who express at least one ApoE4 allele. Three patient groups

are planned: placebo, 1.0mg/kg and 2.0 mg/kg of XPro once weekly by subcutaneous injection. Patients will be randomized 1:1:1. The treatment

duration is three months. Top line results are expected in the first half of 2023. The primary endpoint will examine cognition using

the Early AD/MCI Alzheimer's Cognitive Composite (EMACC). Multiple secondary endpoints of cognition (CDR), function (ADCS-ADL MCI, Goal

Attainment Scale, NPI) and biology will also be measured, including MRI studies of white matter pathology. Cerebrospinal fluid (CSF)

will be obtained to evaluate changes in biomarkers of neuroinflammation and neurodegeneration. All patients that complete the study can

enroll in an open-label 12-month extension study.

companies combine MCI and mild AD into one group called Early AD," said CJ Barnum, Head of Neurosciences at INmune. "However,

many of the biomarkers of interest to us differ between MCI and AD patients. This study is not only designed to identify the most appropriate

biomarkers for MCI patients, but also to assess XPro's ability to improve biomarkers of cognition in a way that, if successful,

could accelerate our timelines to market."

blinded randomized Phase II trial using Quellor to treat respiratory failure in patients with COVID-19 has been closed by the Company

due to the rapidly changing COVID-19 therapeutic landscape. Mortality has decreased ten-fold with all patients receiving immunosuppressive

corticosteroids. Moreover, most high-risk patients have received vaccinations and oral therapies are soon to be approved. We believe

the FDA is no longer offering emergency use authorization (EUA) approvals for this type of therapy after a single Phase II trial. These

forces make continued development expensive and difficult. As a result, the Company has decided clinical development for prevention of

respiratory failure from COVID-19 is a high risk, low reward program. Considering the very promising results from the Phase I AD trial

and the rapidly changing regulatory landscape for Alzheimer's disease, the Company believes investment in the acceleration of our

Phase II mild AD and MCI programs is a better use of the Company's resources.

Q3 2021 and Recent Corporate Highlights

IINKmune Platform Highlights:

Platform Highlights:

Corporate Highlights:

Financial Results for the Third Quarter Ended September

loss attributable to common stockholders for the quarter ended September 30, 2021 was approximately $9.5 million, compared to approximately

$4.7 million for the quarter ended September 30, 2020.

and development expense totaled approximately $6.5 million for the quarter ended September 30, 2021, compared to approximately $2.4 million

during the quarter ended September 30, 2020.

and administrative expense was approximately $2.5 million for the quarter ended September 30, 2021, compared to approximately $2.5 million

during the quarter ended September 30, 2020.

of September 30, 2021, the Company had cash and cash equivalents of approximately $84.5 million.

of November 3, 2021, the Company had approximately 17.8 million common shares outstanding.

participate in this event, please dial-in approximately 5 to 10 minutes before the beginning of the call.

Time: 4:30 PM Eastern Time

Participant Dial-in: 1-877-407-0784

Participant Dial-in (international): 1-201-689-8560

Conference ID: 13724272

live audio webcast of the call can be accessed using this link:

transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through November 10, 2021 by dialing

11-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13721921.

is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and differentiates itself from existing

TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro 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 please visit this section of the INmune Bio's website.

is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple,

essential priming signals akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered

by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances

its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide

variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer.

About 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 cancer (INB03 ), Mild Alzheimer's disease, Mild

Cognitive Impairment and treatment resistant depression (XPro(). 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.

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 , XPro, 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

Moss, CFO (858) 964-3720

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)