Full Press Release Details
INmune Bio, Inc. Announces First Quarter 2022 Results and Provides
Company Dosed First Phase 2 Mild Alzheimer's
Disease Patient with Xpro1595; Presented Data from Ongoing INKmune Studies Suggesting Increased NK Cell Treatment Effective Against
$66.7 Million in cash as of March 31, 2022
Company to Host Conference
Call Today, May 5, at 4:30pm ET
BOCA RATON, FL., May 05, 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 quarter ended March 31, 2022 and
provided a business update.
Q1 2022 and Recent Corporate Highlights
DN-TNF Platform Highlights (XPro and INB03):
INKmune Platform Highlights:
Upcoming Milestones:
"Our scientific platforms continue to showcase our unique
approach to repairing dysfunction of the innate immune system," stated RJ Tesi, M.D., CEO of INmune Bio. "In April, we announced
the dosing of our first patient treated with XPro1595 ("XPro ) in the treatment of neuroinflammation as a cause of mild Alzheimer's
disease (AD) in a Phase II clinical trial AD02, a blinded, randomized, placebo-controlled multicenter study in Australia, in Canada and
in the United States that will assess the cognitive and functional impact of XPro in 201 mild AD patients. A second blinded, randomized,
placebo-controlled Phase 2 trial in patients with mild cognitive impairment (MCI) is also planned. It appears that targeting amyloid
and tau have little therapeutic benefit. Newer treatment strategies such as targeting glial dysfunction with XPro is supported
by pre-clinical and epidemiologic studies. We expect top-line results from both clinical trials in 2023."
"The impact of inflammation and in particular TNF is increasingly
apparent as evinced by recent genetic (link) studies," stated CJ Barnum, VP of CNS Development at INmune Bio. "These
Phase 2 studies are the first step in determining the extent to which neutralizing solTNF will benefit MCI and AD patients. Our expectations
are high, and we look forward to sharing the results next year.
"The clinical and scientific framework around INKmune ,
our NK cell targeting platform continues to grow. We have already observed that two of the three patients treated with INKmune
for MDS/AML remain off therapy with their disease controlled for more than 6 months since their last dose of INKmune ," said
Dr. Mark Lowdell, Chief Scientific Officer of INmune Bio. "We are demonstrating the effectiveness of INKmune in treatment
of hematologic malignancies but believe the most promising application will be using INKmune to treat residual disease in solid
"Separately, we presented additional pre-clinical breast cancer
data at the American Association for Cancer Research (AACR) Annual Meeting 2022, which further demonstrated the use of our DN-TNF oncology
drug candidate, INB03, to potentially help reverse resistance to immunotherapy for women with HER2+ breast cancer. With this robust collection
of data in multiple indications, we are optimistic for the coming quarters and look forward to sharing our continued results with shareholders
and clinicians alike," stated Dr. Tesi.
"We continue to move forward on our planned three Phase II programs
this year and believe we are well positioned to deliver on potential value creating milestones in both our DN-TNF and INKmune platforms,"
Financial Results for the Quarter Ended March
Net loss attributable to common stockholders for the quarter ended
March 31, 2022 was approximately $6.9 million, compared to approximately $4.6 million for the quarter ended March 31, 2021.
Revenues totaled approximately $0.2 million for the first quarter 2022
compared to approximately $0.0 million for the first quarter 2021.
Research and development expense totaled approximately $4.3 million
for the first quarter 2022 compared to approximately $2.5 million during the first quarter 2021.
General and administrative expense was approximately $2.3 million for
the first quarter 2022 compared to approximately $2.1 million during the first quarter 2021.
Other expense was approximately $0.4 million for the first quarter
2022 compared to approximately $0.0 million during the first quarter 2021.
As of March 31, 2022, the Company had cash and cash equivalents of
approximately $66.7 million.
During the quarter, RJ Tesi, Mark Lowdell, David Moss and Kelly Ganjei
bought 82,900 shares for approximately $700,000 as previously reported in an 8-K filed with the SEC. As of May 5, 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: 13728543
A live audio webcast of the call can be accessed using this link: https://services.choruscall.com/mediaframe/webcast.html?webcastid=Z4P1Gioe
A transcript will follow approximately 24 hours from the scheduled
call. A replay will also be available through May 12, 2022 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN
XPro is a next-generation inhibitor of tumor necrosis factor
(TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble
TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential 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
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.
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 Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative
technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases.
DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03 ), Mild Alzheimer's disease,
Mild Cognitive Impairment and treatment-resistant depression (XPro ). The Natural Killer Cell Priming Platform includes INKmune
developed to prime a 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 and solid tumor malignancies, 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 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, and INKmune are
still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA)
or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body 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