Full Press Release Details
Inc. Announces First Quarter 2021 Results and Provides Business Update
Company to host conference call today,
LA JOLLA, Calif., May 05, 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 first quarter ended March 31, 2021 and provided a business update.
"We continued to treat patients in
the Phase I XPro1595 Alzheimer's disease trial and expand the extensive biomarker data," stated RJ Tesi, M.D., chief
executive officer of INmune Bio. "The interim data that we reported in January confirms that XPro1595 decreases neuroinflammation
in patients with Alzheimer's disease and supports transitioning to a blinded randomized placebo-controlled Phase II trial
later this year. We regard these results as extremely promising and look forward to further confirmation of XPro1595's potential
benefit to these patients in a rigorously designed Phase 2 study. We will report the additional biomarker data later this Summer."
"We have started screening patients
in the Phase I INKmune NK cell priming platform trial in patients with high-risk myelodysplastic syndrome (MDS). MDS is a serious
hematopoietic stem cell disorder in which patients have functionally defective NK cells, and approximately one-third of cases progress
to AML. We created a short 5-minute video that we believe does a wonderful job explaining why NK cells fail to clear cancer and
how the cellular and molecular interactions by INKmune activate NK cells to kill resistant tumors. The video can be found by clicking
"Finally, in our Phase 2 trial of
Quellor in hospitalized COVID-19 patients with pulmonary complications, we continue to enroll patients. We expect to receive a
go/no-go' decision by the independent Data Safety Monitoring Board following the analysis of the first 100 patients.
We believe Quellor will neutralize soluble TNF, the master cytokine' of the cytokine storm to decrease progressive
respiratory symptoms in these hospitalized patients."
"In summary, notwithstanding the
ongoing pandemic that continues to disrupt drug development timelines around the world, we believe that we are well positioned
to make meaningful advancements across all of our key programs this year," Dr. Tesi concluded.
Q1 2021 and Recent Corporate Highlights
DN-TNF Platform Highlights:
Financial Highlights:
Upcoming Milestones:
Financial Results for the First Quarter
Ended March 31, 2021:
Net loss attributable to common stockholders
for the quarter ended March 31, 2021 was approximately $4.6 million, compared to approximately $2.1 million for the quarter ended
Research and development expense totaled
approximately $2.5 million for the quarter ended March 31, 2021, compared to approximately $0.8 million during the quarter ended
General and administrative expense was
approximately $2.1 million for the quarter ended March 31, 2021, compared to approximately $1.3 million during the quarter ended
As of March 31, 2021, the Company had cash
and cash equivalents of approximately $45.3 million and no debt.
As of May 5, 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: Wednesday, May 5, 2021
Time: 4:30 PM Eastern Time
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 May 12, 2021 by dialing 1-844- 512-2921 or 1-412-317-6671
(international) and entering PIN no. 13718747.
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.
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.
David Moss, CFO (858) 964-3720
The following table summarizes our results
of operations for the periods indicated:
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share
| March 31, 2021 | December 31, 2020 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 45,340 | $ | 21,967 | ||||
| Research and development tax credit receivable | 2,190 | 1,686 | ||||||
| Other tax receivable | 154 | 113 | ||||||
| Prepaid expenses | 1,514 | 220 | ||||||
| Prepaid expenses - related party | 15 | - | ||||||
| TOTAL CURRENT ASSETS | 49,213 | 23,986 | ||||||
| Operating lease - right of use asset - related party | 147 | 156 | ||||||
| Acquired in-process research and development intangible assets | 16,514 | 16,514 | ||||||
| TOTAL ASSETS | $ | 65,874 | $ | 40,656 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 1,572 | $ | 1,518 | ||||
| Accounts payable and accrued liabilities - related parties | 10 | 34 | ||||||
| Deferred liabilities | 591 | 190 | ||||||
| Operating lease, current liability - related party | 23 | 34 | ||||||
| TOTAL CURRENT LIABILITIES | 2,196 | 1,776 | ||||||
| Long-term operating lease liability - related party | 116 | 126 | ||||||
| TOTAL LIABILITIES | 2,312 | 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, 14,932,638 and 13,481,283 shares issued and outstanding, respectively | 15 | 13 | ||||||
| Additional paid-in capital | 101,466 | 72,105 | ||||||
| Accumulated other comprehensive income | 12 | 11 | ||||||
| Accumulated deficit | (37,931 | ) | (33,375 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 63,562 | 38,754 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 65,874 | $ | 40,656 |
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(In thousands, except share and per share
| Three months ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| REVENUE | $ | 4 | $ | - | ||||
| OPERATING EXPENSES | ||||||||
| General and administrative | 2,061 | 1,299 | ||||||
| Research and development | 2,491 | 793 | ||||||
| Total operating expenses | 4,552 | 2,092 | ||||||
| LOSS FROM OPERATIONS | (4,548 | ) | (2,092 | ) | ||||
| OTHER (EXPENSE) INCOME | ||||||||
| Other (expense) income | (8 | ) | 22 | |||||
| Total other (expense) income | (8 | ) | 22 | |||||
| NET LOSS | $ | (4,556 | ) | $ | (2,070 | ) | ||
| Net loss per common share - basic and diluted | $ | (0.32 | ) | $ | (0.19 | ) | ||
| Weighted average number of common shares outstanding - basic and diluted | 14,322,659 | 10,747,300 | ||||||
| COMPREHENSIVE LOSS | ||||||||
| Net loss | $ | (4,556 | ) | $ | (2,070 | ) | ||
| Other comprehensive income (loss) - foreign currency translation | 1 | (21 | ) | |||||
| Total comprehensive loss | $ | (4,555 | ) | $ | (2,091 | ) |
CONSOLIDATED STATEMENTS OF CASH FLOWS
| For the Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (4,556 | ) | $ | (2,070 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 899 | 682 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | (504 | ) | (145 | ) | ||||
| Other tax receivable | (41 | ) | 6 | |||||
| Prepaid expenses | (1,294 | ) | (170 | ) | ||||
| Prepaid expenses - related party | (15 | ) | 26 | |||||
| Accounts payable and accrued liabilities | 54 | 294 | ||||||
| Accounts payable and accrued liabilities - related parties | (24 | ) | 29 | |||||
| Deferred liabilities | 401 | 300 | ||||||
| Operating lease liability - related party | (12 | ) | 13 | |||||
| Net cash used in operating activities | (5,092 | ) | (1,035 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from sale of common stock | 28,446 | 1,003 | ||||||
| Net proceeds from the exercise of warrants | 18 | - | ||||||
| Purchase of common stock | - | (1,012 | ) | |||||
| Net cash provided by (used in) financing activities | 28,464 | (9 | ) | |||||
| Impact on cash from foreign currency translation | 1 | (21 | ) | |||||
| NET INCREASE (DECREASE) IN CASH | 23,373 | (1,065 | ) | |||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 21,967 | 6,996 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 45,340 | $ | 5,931 |