Company to host conference call today, March 4, at 4:30pm ET

LA JOLLA, Calif., March 04, 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 year ended December 31, 2020 and provided a business update.

“A key highlight since our last quarterly update is the updated interim data announced from our ongoing Phase 1b study evaluating XPro1595 in Alzheimer’s disease in January,” stated RJ Tesi, M.D., chief executive officer of INmune Bio. “These data demonstrate that XPro1595 decreases neuroinflammation using multiple biomarkers of inflammation in patients with Alzheimer’s disease. We also gained insight into the consequences of decreasing neuroinflammation in these patients for extended period of time which includes decrease in biomarkers on neurodegeneration and improvement of biomarkers of synaptic function. We remain committed to initiating a Phase 2 study later this year.

“Our Phase 2 trial of Quellor for the treatment of for pulmonary complications patients with COVID-19 continues to enroll patients. While the emergence of safe and effective vaccines appears to be having an impact on infection and hospitalization rates, effective treatment of serious complications remains a significant unmet need. Both the TRD program with XPro1595 and the INKmune program to treat patients with high-risk MDS will begin to enroll patients once the pandemic is better controlled in the US and UK, respectively. We look forward to data from these important studies.

“Finally, we strengthened our balance sheet by raising an additional $28.4 million of net proceeds from the sale of 1,439,480 shares of common stock at an average price of $20.17 through our ATM during January and February 2021, which provides additional capital to fund the Company into 2022.”

Recent Corporate Highlights

DN-TNF Platform Highlights:

  • Announced interim Phase 1b data demonstrating that XPro1595 decreased biomarkers of neuroinflammation and neurodegeneration, as measured by multiple analytic platforms in patients with Alzheimer’s disease.
    • Data supports initiation of a blinded, randomized, placebo-controlled Phase 2 study in 2021 to explore the clinical impact of XPro1595 in patients with Alzheimer’s disease.
    • The biomarker data was presented during a Key Opinion Leader webinar on January 21, 2021, a replay of which can be accessed here.
  • Announced that the first patient has been dosed in the company’s Phase 2 trial of Quellor™ for pulmonary complications in COVID-19 patients.

Financial Highlights:

  • Subsequent to the end of the fourth quarter, raised a net of approximately $28.4 million from the sale of 1,439,480 shares of common stock through a pre-existing open sale market agreement (At-the-Market, or ATM) at an average price of $20.17 per share.

Upcoming Milestones:

  • Report on the first 100 patients enrolled in the company’s Quellor trial in COVID-19 which will provide proof-of-concept and inform a “go/no go” decision by the Data Safety Monitoring Board (DSMB).
  • Additional data from the Phase 1b Alzheimer's disease program.
  • Initiate XPro1595 Phase 2 program for Alzheimer's disease in patients with neuro-inflammation.
  • Initiate XPro1595 Phase 2 program for treatment resistant depression.
  • Initiate Phase 1 program with INKmune™ for high-risk MDS.

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.

  • LIVNate Phase 2 program for NASH.
  • INB03 Phase 2 program for MUC4 expressing cancer.

Financial Results for the Year Ended December 31, 2020:

Net loss attributable to common stockholders for the year ended December 31, 2020 was approximately $12.1 million, compared to approximately $7.7 million for the year ended December 31, 2019.

Research and development expense totaled approximately $5.9 million for the year ended December 31, 2020, compared to approximately $3.3 million during the year ended December 31, 2019.

General and administrative expense was approximately $6.3 million for the year ended December 31, 2020, compared to approximately $6.0 million during the year ended December 31, 2019.

As of December 31, 2020, the Company had cash and cash equivalents of approximately $22.0 million and no debt. Subsequent to December 31, 2020, the company raised a net of approximately $28.4 million at an average price of $20.17 per share from its pre-existing ATM facility.

As of March 4, 2021, the Company had approximately 14.9 million common shares outstanding.

Earnings Call Information

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

Date: Thursday, March 4, 2021
Time: 4:30 PM Eastern Time
Participant Dial-in: 877-407-0784
Participant Dial-in (international): 201-689-8560

Live Webcast Link:

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through March 11 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13715561.

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

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

Forward Looking Statements

Clinical 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
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Investor Contact:
Chuck Padala
LifeSci Advisors
(646) 627-8390
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Media Contact:
Meredith Sosulski, Ph.D.
LifeSci Communications
(929) 469-3851
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The following table summarizes our results of operations for the periods indicated:



    December 31,
    December 31,
CURRENT ASSETS            
Cash   $ 21,966,883     $ 6,995,525  
Research and development tax credit receivable     1,686,065       568,139  
Other tax receivable     112,684       77,225  
Prepaid expenses     220,090       97,623  
Prepaid expenses – related party     -       26,266  
TOTAL CURRENT ASSETS     23,985,722       7,764,778  
Operating lease – right of use asset – related party     156,214       191,543  
Acquired in-process research and development intangible assets     16,514,000       16,514,000  
TOTAL ASSETS   $ 40,655,936     $ 24,470,321  
Accounts payable and accrued liabilities   $ 1,518,113     $ 401,989  
Accounts payable and accrued liabilities – related parties     33,664       290,102  
Deferred liabilities     190,612       -  
Operating lease, current liability – related party     33,873       8,288  
TOTAL CURRENT LIABILITIES     1,776,262       700,379  
Long-term operating lease liability – related party     126,286       160,164  
TOTAL LIABILITIES     1,902,548       860,543  
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, 13,481,283 and 10,770,948 shares issued and outstanding, respectively     13,481       10,771  
Additional paid-in capital     72,104,539       44,833,703  
Common stock issuable     -       50,000  
Accumulated other comprehensive income (loss)     10,708       (8,515 )
Accumulated deficit     (33,375,340 )     (21,276,181 )
TOTAL STOCKHOLDERS’ EQUITY     38,753,388       23,609,778  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY   $ 40,655,936     $ 24,470,321  




    2020     2019  
REVENUE   $ 10,916     $ -  
OPERATING EXPENSES                
General and administrative     6,321,097       6,016,056  
Research and development     5,917,495       3,281,945  
Gain on waiver of common stock issuable     -       (1,542,000 )
Total operating expenses     12,238,592       7,756,001  
LOSS FROM OPERATIONS     (12,227,676 )     (7,756,001 )
OTHER INCOME                
Other income     128,517       77,688  
Total other income     128,517       77,688  
NET LOSS   $ (12,099,159 )   $ (7,678,313 )
Net loss per common share – basic and diluted   $ (1.01 )   $ (0.75 )
Weighted average number of common shares outstanding – basic and diluted     11,988,492       10,272,641  
COMPREHENSIVE LOSS                
Net loss   $ (12,099,159 )   $ (7,678,313 )
Other comprehensive (income) loss – foreign currency translation     19,223       (15,044 )
Total comprehensive loss   $ (12,079,936 )   $ (7,693,357 )




    2020     2019  
Net loss   $ (12,099,159 )   $ (7,678,313 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Stock-based compensation     3,112,004       4,096,538  
Gain on waiver of common stock issuable     -       (1,542,000 )
Changes in operating assets and liabilities:                
Research and development tax credit receivable     (1,117,926 )     24,076  
Other tax receivable     (35,459 )     (39,843 )
Joint development cost receivable     -       17,989  
Prepaid expenses     (122,467 )     (82,071 )
Prepaid expenses – related party     26,266       (26,266 )
Accounts payable and accrued liabilities     1,116,124       (151,232 )
Accounts payable and accrued liabilities – related parties     (40,677 )     19,557  
Deferred liabilities     190,612       -  
Operating lease liability – related party     27,036       (23,091 )
Net cash used in operating activities     (8,943,646 )     (5,384,656 )
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     19,223       (15,044 )
NET INCREASE IN CASH     14,971,358       6,809,321  
CASH AT BEGINNING OF YEAR     6,995,525       186,204  
CASH AT END OF YEAR   $ 21,966,883     $ 6,995,525  
Cash paid for income taxes   $ -     $ -  
Cash paid for interest expense   $ -     $ -  
Capital contribution   $ 215,761     $ -  
Cashless exercise of warrants   $ 2     $ -  
Issuance of common stock issuable   $ 50,000     $ 3,084,000  
Issuance of warrants to placement agents   $ -     $ 247,452  


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