Full Press Release Details
Bio, Inc. Announces Third Quarter Results and Provides Business Update
conference call today, November 5, at 4:30pm ET
Nov. 05, 2020 (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 third quarter ended September 30, 2020 and provided a business update.
second quarter update, we have made progress with our neuroinflammation franchise. First, we reported positive Phase 1b data in
July demonstrating that XPro1595 decreased neuroinflammation by more than 40% in the arcuate fasciculus, a white matter pathway
important for learning and memory in Alzheimer's patients. More recently, we announced receipt of an NIH Small Business
Innovation Research Grant of up to $2.9 million to support a Phase 2 study of XPro1595 in treatment resistant depression patients,
or TRD," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "We believe that TRD represents an important
expansion of our neuroinflammation program, and we are working hard to initiate Phase 2 trials in Alzheimer's and TRD next
we continue to advance our other programs across both our DN-TNF and INKmune platforms. In DN-TNF, we have opened a Phase II clinical
trial using Quellor to treat patients hospitalized from complications of COVID-19. In 2021, assuming the clinical landscape has
not changed, and the pandemic is controlled, we will initiate planning for the Phase II trials of LIVNate in NASH and INB03 in
cancer. We are also poised to advance our INKmune programs in ovarian cancer and high-risk MDS as well. Overall, we are pleased
with our progress in the third quarter and year-to-date," concluded Dr. Tesi.
Corporate Highlights
Financial Highlights:
Upcoming Milestones:
additional clinical trials after the COVID-19 pandemic has been controlled. The exact timing of these trials cannot be predicted
for the Third Quarter Ended September 30, 2020:
Net loss attributable
to common stockholders for the third quarter ended September 30, 2020 was approximately $4.7 million, compared to approximately
$3.1 million for the quarter ended September 30, 2019.
Research and development
expense totaled approximately $2.4 million for the third quarter ended September 30, 2020, compared to approximately $1.2 million
during the third quarter ended September 30, 2019.
General and administrative
expense was approximately $2.5 million for the quarter ended September 30, 2020, compared to approximately $1.9 million during
the third quarter ended September 30, 2019.
30, 2020, the Company had cash and cash equivalents of approximately $24.3 million and no debt. September 30 cash and cash equivalents
reflects a public offering of common stock which the company completed in July which raised net proceeds of approximately $23.1
2020, the Company had approximately 13.4 million common shares outstanding.
this event, dial approximately 5 to 10 minutes before the beginning of the call.
Time: 4:30 PM Eastern Time
Participant Dial-in: 800-909-4145
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follow approximately 24 hours from the scheduled call. A replay will also be available through November 12 by dialing 1-844-512-2921
or 1-412-317-6671 (international) and entering PIN no. 21970461.
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 (https://www.inmunebio.com/index.php/en/science/xpro1595/overview).
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.
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
Meredith Sosulski, Ph.D.
LifeSci Communications
The following table summarizes our results of operations for
the periods indicated:
CONSOLIDATED BALANCE SHEETS
| September 30, 2020 | December 31, 2019 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 24,311,153 | $ | 6,995,525 | ||||
| Research and development tax incentive receivable | 1,465,377 | 568,139 | ||||||
| Other tax receivable | 143,657 | 77,225 | ||||||
| Prepaid expenses | 216,871 | 97,623 | ||||||
| Prepaid expenses - related party | - | 26,266 | ||||||
| TOTAL CURRENT ASSETS | 26,137,058 | 7,764,778 | ||||||
| Operating lease - right of use asset - related party | 165,388 | 191,543 | ||||||
| Acquired in-process research and development intangible assets | 16,514,000 | 16,514,000 | ||||||
| TOTAL ASSETS | $ | 42,816,446 | $ | 24,470,321 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 1,191,086 | $ | 401,989 | ||||
| Accounts payable and accrued liabilities - related parties | 9,132 | 290,102 | ||||||
| Deferred liabilities | 253,709 | - | ||||||
| Operating lease, current liability - related party | 20,183 | 8,288 | ||||||
| TOTAL CURRENT LIABILITIES | 1,474,110 | 700,379 | ||||||
| Long-term operating lease liability - related party | 136,043 | 160,164 | ||||||
| TOTAL LIABILITIES | 1,610,153 | 860,543 | ||||||
| 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, 13,447,948 and 10,770,948 shares issued and outstanding, respectively | 13,448 | 10,771 | ||||||
| Additional paid-in capital | 71,351,634 | 44,833,703 | ||||||
| Common stock issuable | 50,000 | 50,000 | ||||||
| Accumulated other comprehensive loss | (37,735 | ) | (8,515 | ) | ||||
| Accumulated deficit | (30,171,054 | ) | (21,276,181 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 41,206,293 | 23,609,778 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 42,816,446 | $ | 24,470,321 |
CONSOLIDATED STATEMENTS OF OPERATIONS
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| REVENUE | $ | - | $ | - | $ | - | $ | - | ||||||||
| OPERATING EXPENSES | ||||||||||||||||
| General and administrative | 2,456,266 | 1,916,200 | 4,960,106 | 4,550,306 | ||||||||||||
| Research and development | 2,362,880 | 1,167,986 | 4,058,710 | 2,415,390 | ||||||||||||
| Waiver of common stock issuable | - | - | - | (1,542,000 | ) | |||||||||||
| Total operating expenses | 4,819,146 | 3,084,186 | 9,018,816 | 5,423,696 | ||||||||||||
| LOSS FROM OPERATIONS | (4,819,146 | ) | (3,084,186 | ) | (9,018,816 | ) | (5,423,696 | ) | ||||||||
| OTHER INCOME | 102,484 | 17,220 | 123,943 | 63,602 | ||||||||||||
| NET LOSS | $ | (4,716,662 | ) | $ | (3,066,966 | ) | $ | (8,894,873 | ) | $ | (5,360,094 | ) | ||||
| Net loss per common share - basic and diluted | $ | (0.36 | ) | $ | (0.28 | ) | $ | (0.77 | ) | $ | (0.53 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 12,926,539 | 10,762,473 | 11,496,753 | 10,105,675 | ||||||||||||
| COMPREHENSIVE LOSS | ||||||||||||||||
| Net loss | $ | (4,716,662 | ) | $ | (3,066,966 | ) | $ | (8,894,873 | ) | $ | (5,360,094 | ) | ||||
| Other comprehensive loss on foreign currency translation | (47,861 | ) | (35,542 | ) | (29,220 | ) | (61,278 | ) | ||||||||
| Total comprehensive loss | $ | (4,764,523 | ) | $ | (3,102,508 | ) | $ | (8,924,093 | ) | $ | (5,421,372 | ) |
CONSOLIDATED STATEMENTS OF CASH FLOWS
| For the Nine Months Ended September 30, | ||||||||
| 2020 | 2019 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (8,894,873 | ) | $ | (5,360,094 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 2,409,066 | 2,924,091 | ||||||
| Waiver of common stock issuable | - | (1,542,000 | ) | |||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax incentive receivable | (897,238 | ) | (361,769 | ) | ||||
| Other tax receivable | (66,432 | ) | (68,460 | ) | ||||
| Joint development cost receivable | - | 17,989 | ||||||
| Prepaid expenses | (119,248 | ) | (106,478 | ) | ||||
| Prepaid expenses - related party | 26,266 | (118,602 | ) | |||||
| Accounts payable and accrued liabilities | 789,097 | (215,983 | ) | |||||
| Accounts payable and accrued liabilities - related parties | (65,209 | ) | (108,434 | ) | ||||
| Deferred liabilities | 253,709 | - | ||||||
| Operating lease liability - related party | 13,929 | (11,546 | ) | |||||
| Net cash used in operating activities | (6,550,933 | ) | (4,951,286 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| 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 | (29,220 | ) | (61,278 | ) | ||||
| NET INCREASE IN CASH | 17,315,628 | 7,196,457 | ||||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 6,995,525 | 186,204 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 24,311,153 | $ | 7,382,661 | ||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||||||
| Cash paid for income taxes | $ | - | $ | - | ||||
| Cash paid for interest expense | $ | - | $ | - | ||||
| NONCASH INVESTING AND FINANCING ACTIVITIES: | ||||||||
| Capital contribution | $ | 215,761 | $ | - | ||||
| Cashless exercise of warrants | $ | 2 | $ | - | ||||
| Issuance of warrants to placement agents | $ | - | $ | 247,452 | ||||
| Issuance of common stock issuable | $ | - | $ | 3,084,000 |