Full Press Release Details
INmune Bio, Inc. Announces Fourth Quarter
and Full Year 2021 Results and Provides Business Update
Opens Phase 2 mild Alzheimer's trial and reports positive
patient data from ongoing INKmuneTM trial in patient with high-risk myelodysplastic syndrome
Cash of $74.8 million on December 31, 2021
Company to host conference call today, March 3, at 4:30pm ET
Boca Raton, Florida, March 03, 2022 (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, 2021 and provided a business update.
In December, the Company reported data from the
first patient treated with INKmuneTM in the myelodysplastic syndrome (MDS) Phase I clinical trial. More than 100 days
after the course of INKmuneTM therapy, 60% of the patient's NK cells showed the activated, tumor killing memory
like NK cells phenotype, a fourfold increase from pre-treatment. The patient's memory like NK cells killed >70% of NK resistant
tumor cells in an in vitro assay. The patient remains well and with an ECOG status of 0, a two-point drop from pre-treatment. Additionally,
two patients were treated with INKmuneTM under compassionate use after having failed at least one allogeneic bone marrow
transplant. One of the two patients has been discharged home, one remains hospitalized. In all cases, INKmuneTM therapy
was well tolerated, safe and was given without any type of pre-medication or cytokine therapy.
"These patients demonstrate the unique attributes
of INKmuneTM therapy in patients with high-risk MDS/AML. INKmuneTM converted the patient's resting
NK cells into cancer killing memory like NK cells. The memory like NK cells killed NK-resistant cancer cells in an in vitro assay.
Both these attributes lasted four months, a trait we are calling therapeutic persistence." stated RJ Tesi, M.D., Chief
Executive Officer of INmune Bio. "We are continuing to screen patients for enrollment into the trial and are in process of expanding
the number of clinical trial sites."
The Phase II clinical trial using XProTM to
treat patients with AD and elevated biomarkers of neuroinflammation (ADi) is open, screening patients and seeking to enroll the first
patient. A second Phase II trial in patients with Mild Cognitive Impairment (MCI) should begin enrolling patients soon. Patients must
have ApoE4 to be included in the MCI trial. INMB is treating MCI and Mild AD in separate clinical trials due to differences in disease
severity with the potential for different rates of response to therapy. The MCI trial is a three-month trial designed to determine
the extent to which XProTM has an impact on biological and cognitive biomarkers in MCI patients. The mild AD trial is
a six-month trial with EMACC as the primary endpoint and secondary endpoints of CDR, ADL, NPI, MRI, and blood biomarkers of neurodegeneration.
Top line data is expected in the first half of 2023 from the MCI trial and the second half of 2023 from the mild ADi trial. A video released
today can be found on the company's website which explains our rationale for XPro in treating neuroinflammation to potentially
reduce white and gray matter degeneration which can be found by clicking here.
Q4 2021 and Recent Corporate Highlights
IINKmuneTM Platform Highlights:
Platform Highlights (XProTM and INB03TM):
Financial Results for the Year Ended December
Net loss attributable to common stockholders for
the year ended December 31, 2021 was approximately $30.3 million, compared to approximately $12.1 million for the year ended December
Revenues were approximately $0.2 million for the
year ended December 31, 2021, compared to $0.0 million for the year ended December 31, 2020.
Research and development expense totaled approximately
$20.5 million for the year ended December 31, 2021, compared to approximately $5.9 million during the year ended December 31, 2020.
General and administrative expense was approximately
$8.8 million for the year ended December 31, 2021, compared to approximately $6.3 million during the year ended December 31, 2020.
Other expense was approximately $1.2 million during
the year ended December 31, 2021 compared to other income of approximately $0.1 million during the year ended December 31, 2020.
As of December 31, 2021, the Company had cash
of approximately $74.8 million.
As of March 3, 2022, the Company had approximately
17.9 million common shares outstanding.
Earnings Call Information
To participate in this event, dial approximately
5 to 10 minutes before the beginning of the call.
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-407-0784
Participant Dial-in (international): 1-201-689-8560
Conference ID: 13726701
A live audio webcast of the call can be accessed using this link: https://viavid.webcasts.com/starthere.jsp?ei=1526567&tp_key=636ec61ab2
A transcript will follow approximately 24 hours
from the scheduled call. A replay will also be available through March 10, 2022 by dialing 1-844-512-2921 or 1-412-317-6671 (international)
and entering PIN no. 13726701.
XProTM 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. XProTM 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
derivative of our proprietary INB16 cell line, a human tumor cell line, which conjugates to resting NK cells and delivers multiple essential
priming signals akin to treatment with a combination of at least three cytokines. INKmuneTM is stable at -80 C
and is delivered by a simple IV infusion. The INKmuneTM: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 tumor lysis. Tumor-primed
NK (TpNK) cells can lyse a wide variety of NK-resistant tumors, including: leukemias, lymphomas, myeloma, ovarian cancer, and 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 (XProTM). 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.
Information about 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 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 ,
XProTM, 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. 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