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

Key Takeaway: INmune Bio, Inc. Announces Second Quarter 2021 Results and Provides Business Update BOCA RATON, Fla., Aug. 04, 2021 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patie

Full Press Release Details

INmune Bio, Inc. Announces Second Quarter
2021 Results and Provides Business Update
BOCA RATON, Fla., Aug. 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 second quarter ended
June 30, 2021 and provided a business update.
"We continue our planning and setup
for a Phase 2 clinical trial of our lead candidate, XPRO (Xpro1595 ), in patients with mild Alzheimer's disease, which
we plan to initiate by year-end," stated RJ Tesi, M.D. "We have already demonstrated that XPRO can reduce neuroinflammation
and decreases biomarkers of neurodegeneration and improve synaptic function. If successful in Phase 2, we believe XPRO has the
potential to be among the most significant advancements in the treatment of Alzheimer's Disease (AD) and other neurodegenerative
diseases in many years."
Dr. Tesi continued, "At the Alzheimer's
Association International Conference last week, we introduced a new biomarker - Apparent Fiber Density (AFD), a measure of axonal integrity
measured by MRI. XPRO increases AFD in patients receiving 1mg/kg/week. We believe the novel non-invasive white matter analytics
of white matter free water and apparent fiber density will be very useful in the development of XPRO in AD, Treatment Resistant
Depression (TRD) and the many other CNS indications we hope to attack in the future."
"With the completion of a registered
direct offering during July 2021 in which the Company raised $36.9 million of net proceeds combined with the Company raising $15.0 million
of net proceeds from the sale of common stock through the ATM, also in July 2021, we are well financed to Phase 2 Alzheimer's data
and other milestones such as clinical data from INKmune and other developments with our DN-TNF franchise assuming no material delays caused
by the pandemic," said David Moss, CFO.
"Last month, we treated the first patient
in the first Phase 1 clinical trial of our NK cell priming platform, INKmune, in high-risk myelodysplastic syndrome (MDS)," stated
RJ Tesi, M.D. "We are calling INKmune a pseudokine because, in vitro, it converts the resting NK cells into memory-like NK cells
that can kill cancer cells as well or better than NK cells treated cytokines such as IL-12, IL-15 and IL-18 alone or in combination."
"Our preliminary data from the first
patient treated with INKmune support the safety of this approach and give the first confirmation that the in vitro effects of INKmune
on NK cells does translate to patients," said Professor Mark Lowdell, PhD. "I am particularly excited to see NK cells expanding
in our first patient, treated at the lowest dose, which are activated and express cytotoxicity receptors for tumor cells. We are planning
to open a second site for the MDS trial in the UK shortly and to open a second Phase 1 trial, in ovarian cancer in the coming months;
although both are subject to ongoing COVID-related restrictions."
Q2 2021 and Recent Corporate Highlights INKmune Platform Highlights:
DN-TNF Platform Highlights:
Financial Highlights:
Upcoming Milestones:
Financial Results for the Second Quarter Ended June
Net loss attributable to common stockholders
for the quarter ended June 30, 2021 was approximately $6.7 million, compared to approximately $2.1 million for the quarter ended June
Research and development expense totaled approximately
$4.5 million for the quarter ended June 30, 2021, compared to approximately $0.9 million during the quarter ended June 30, 2020.
General and administrative expense was approximately
$2.1 million for the quarter ended June 30, 2021, compared to approximately $1.2 million during the quarter ended June 30, 2020.
As of June 30, 2021, the Company had cash
and cash equivalents of approximately $39.5 million.
As of August 4, 2021, the Company had approximately
17.7 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: Wednesday, August 4, 2021
Time: 4:30 PM Eastern Time
Participant Dial-in: 877-407-0784
Participant Dial-in (international): 201-689-8560
A transcript will follow approximately 24
hours from the scheduled call. A replay will also be available through August 11, 2021 by dialing 11-844-512-2921 or 1-412-317-6671 (international)
and entering PIN no. 13721921.
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.
INKmune 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 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 www.inmunebio.com.
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.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
June 30, 2021 December 31, 2020
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 39,520 $ 21,967
Research and development tax credit receivable 3,068 1,686
Other tax receivable 51 113
Prepaid expenses 1,395 220
Prepaid expenses - related party 15 -
TOTAL CURRENT ASSETS 44,049 23,986
Operating lease - right of use asset - related party 137 156
Acquired in-process research and development intangible assets 16,514 16,514
TOTAL ASSETS $ 60,700 $ 40,656
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities $ 2,361 $ 1,518
Accounts payable and accrued liabilities - related parties 9 34
Deferred liabilities 583 190
Operating lease, current liability - related party 36 34
TOTAL CURRENT LIABILITIES 2,989 1,776
Long-term debt, less debt discount 14,348 -
Long-term operating lease liability - related party 106 126
Accrued liabilities - long-term 24 -
TOTAL LIABILITIES 17,467 1,902
COMMITMENTS AND CONTINGENCIES
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, 15,125,171 and 13,481,283 shares issued and outstanding, respectively 15 13
Additional paid-in capital 87,854 72,105
Accumulated other comprehensive (loss) income (50 ) 11
Accumulated deficit (44,586 ) (33,375 )
TOTAL STOCKHOLDERS' EQUITY 43,233 38,754
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 60,700 $ 40,656
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
Last updated: Aug 4, 2021