Full Press Release Details
Inc. Announces Third Quarter 2022 Results and Provides Business Update
Host Conference Call Today, November 2, at 4:30pm ET
Fla., Nov. 02, 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 September 30, 2022 and provides a business update.
Q3 2022 and Recent Corporate Highlights
Platform Highlights (XPro and INB03):
Events and Milestones:
first patient enrolled in the AD02 trial, a randomized, blinded, placebo-controlled study of XPro in patients with Mild Alzheimer's
Disease (AD) with biomarkers of neuroinflammation, has completed the six-month study," stated RJ Tesi, M.D., CEO of INmune Bio.
"All patients that complete the six-month study will be eligible to receive XPro under a separate open label extension study. Our
international, multicenter trial strategy has not changed and pending conclusion of the FDA's XPro manufacturing inquiry,
our plan to launch additional blinded, randomized, placebo-controlled Phase 2 trials in patients with mild cognitive impairment (MCI)
and TRD will commence."
INKmune platform continues to pivot towards solid tumors. Data presented at the Innate Killer Europe conference demonstrated the
ability of INKmune-primed NK cells to fight solid tumors in the hostile environment of the TME. Improving NK cell therapeutic
effectiveness in solid tumors such as prostate, renal cell, and nasopharyngeal cancer is an important unmet need in cancer therapy,"
using DN-TNF (INB03) to reverse resistance to immunotherapy will occur this quarter. In the animal models, DN-TNF changes the immunobiology
of the tumor and TME to make them more susceptible to immunotherapy such as ADCs. Although much of the data are in MUC4+/HER2+ breast
cancer, the data are relevant in gastric, pancreatic, and other malignancies expressing MUC4. "Despite advances in the treatment
of HER2+ breast cancer with ADCs, 50% of women relapse after 24 months," added Dr. Tesi. "Combination with DN-TNF may provide
these patients with additional therapeutic opportunities."
Financial Results for the Quarter Ended September
attributable to common stockholders for the quarter ended September 30, 2022 was approximately $7.7 million, compared to approximately
$9.5 million for the quarter ended September 30, 2021.
and development expense totaled approximately $5.2 million for the recent quarter compared to approximately $6.5 million during the quarter
ended September 30, 2021.
administrative expense was approximately $2.4 million for the quarter compared to approximately $2.5 million during the quarter ended
was approximately $0.3 million for the quarter ended September 30, 2022 compared to approximately $0.4 million during the quarter ended
30, 2022, the Company had cash and cash equivalents of approximately $57.4 million.
As of November 2, 2022, the Company had approximately 17.9 million common shares outstanding.
in this event, dial approximately 5 to 10 minutes before the beginning of the call.
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Conference ID: 13728541
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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 website.
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.
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.
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 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.
(516) 842-9614 x-823
tables summarize our results of operations for the periods indicated:
(In thousands, except share and per share amounts)
| September 30, 2022 | December 31, 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 57,405 | $ | 74,810 | ||||
| Research and development tax credit receivable | 4,417 | 4,913 | ||||||
| Other tax receivable | 114 | 591 | ||||||
| Prepaid expenses | 4,599 | 2,278 | ||||||
| Prepaid expenses - related party | 123 | 14 | ||||||
| TOTAL CURRENT ASSETS | 66,658 | 82,606 | ||||||
| Operating lease - right of use asset | 529 | 726 | ||||||
| Other assets | 99 | 99 | ||||||
| Acquired in-process research and development intangible assets | 16,514 | 16,514 | ||||||
| TOTAL ASSETS | $ | 83,800 | $ | 99,945 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 3,465 | $ | 3,733 | ||||
| Accounts payable and accrued liabilities - related parties | 8 | 80 | ||||||
| Deferred liabilities | 778 | 474 | ||||||
| Current portion of long-term debt | 2,500 | - | ||||||
| Operating lease, current liabilities | 144 | 72 | ||||||
| TOTAL CURRENT LIABILITIES | 6,895 | 4,359 | ||||||
| Long-term debt, net | 12,129 | 14,458 | ||||||
| Long-term operating lease liabilities | 607 | 704 | ||||||
| Accrued liability - long-term | 463 | 199 | ||||||
| TOTAL LIABILITIES | 20,094 | 19,720 | ||||||
| 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, 17,945,995 and 17,843,303 shares issued and outstanding, respectively | 18 | 18 | ||||||
| Additional paid-in capital | 150,011 | 143,921 | ||||||
| Accumulated other comprehensive (loss) income | (1,142 | ) | 1 | |||||
| Accumulated deficit | (85,181 | ) | (63,715 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 63,706 | 80,225 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 83,800 | $ | 99,945 |
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| REVENUE | $ | 98 | $ | 14 | $ | 277 | $ | 18 | ||||||||
| OPERATING EXPENSES | ||||||||||||||||
| General and administrative | 2,382 | 2,515 | 6,929 | 6,666 | ||||||||||||
| Research and development | 5,159 | 6,520 | 13,657 | 13,475 | ||||||||||||
| Total operating expenses | 7,541 | 9,035 | 20,586 | 20,141 | ||||||||||||
| LOSS FROM OPERATIONS | (7,443 | ) | (9,021 | ) | (20,309 | ) | (20,123 | ) | ||||||||
| OTHER EXPENSE, NET | (282 | ) | (437 | ) | (1,157 | ) | (546 | ) | ||||||||
| NET LOSS | $ | (7,725 | ) | $ | (9,458 | ) | $ | (21,466 | ) | $ | (20,669 | ) | ||||
| Net loss per common share - basic and diluted | $ | (0.43 | ) | $ | (0.55 | ) | $ | (1.20 | ) | $ | (1.33 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 17,945,995 | 17,329,379 | 17,921,036 | 15,553,344 | ||||||||||||
| COMPREHENSIVE LOSS | ||||||||||||||||
| Net loss | $ | (7,725 | ) | $ | (9,458 | ) | $ | (21,466 | ) | $ | (20,669 | ) | ||||
| Other comprehensive loss - foreign currency translation | (441 | ) | (68 | ) | (1,143 | ) | (129 | ) | ||||||||
| Total comprehensive loss | $ | (8,166 | ) | $ | (9,526 | ) | $ | (22,609 | ) | $ | (20,798 | ) |
STATEMENTS OF CASH FLOWS
| For the Nine Months Ended September 30, | ||||||||
| 2022 | 2021 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (21,466 | ) | $ | (20,669 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 5,361 | 3,274 | ||||||
| Accretion of debt discount | 171 | 69 | ||||||
| Impairment of operating lease - right of use asset | 89 | - | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | 496 | (3,272 | ) | |||||
| Other tax receivable | 477 | (75 | ) | |||||
| Prepaid expenses | (2,321 | ) | (1,080 | ) | ||||
| Prepaid expenses - related party | (109 | ) | (14 | ) | ||||
| Other assets | - | (99 | ) | |||||
| Accounts payable and accrued liabilities | (268 | ) | 2,703 | |||||
| Accounts payable and accrued liabilities - related parties | (72 | ) | (24 | ) | ||||
| Deferred liabilities | 304 | 351 | ||||||
| Accrued liability - long-term | 264 | 111 | ||||||
| Operating lease liabilities | 83 | 1 | ||||||
| Net cash used in operating activities | (16,991 | ) | (18,724 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Cash paid to Xencor to settle warrant for acquired research and development intangible assets | - | (15,000 | ) | |||||
| Net cash used in investing activities | - | (15,000 | ) | |||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from sale of common stock | 699 | 80,253 | ||||||
| Net proceeds from exercise of stock options | - | 1,135 | ||||||
| Net proceeds from the exercise of warrants | 30 | 18 | ||||||
| Net proceeds from the issuance of debt | - | 14,951 | ||||||
| Net cash provided by financing activities | 729 | 96,357 | ||||||
| Impact on cash from foreign currency translation | (1,143 | ) | (129 | ) | ||||
| NET (DECREASE) INCREASE IN CASH | (17,405 | ) | 62,504 | |||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 74,810 | 21,967 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 57,405 | $ | 84,471 | ||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||||||
| Cash paid for income taxes | $ | - | $ | - | ||||
| Cash paid for interest expense | $ | 962 | $ | 265 | ||||
| NONCASH INVESTING AND FINANCING ACTIVITIES: | ||||||||
| Common stock issued to Xencor to settle warrant issued for acquired research and development intangible assets | $ | - | $ | 3,300 | ||||
| Warrants issued as debt inducement | $ | - | $ | 619 |