INMUNE BIO, INC. Q1 2023 Corporate Highlights:
DN-TNF Platform Highlights (XPro™ and INB03™):
- AD02 blinded randomized Phase 2 clinical trial in patients with early Alzheimer’s Disease (AD) continues to enroll in
Australia andCanada . The company is actively pursuing other regulatory venues to expand the clinical trial footprint. The company announced consolidation of the mild ADi and Mild Cognitive Impairment Phase 2 programs into a single trial to improve the efficiency and align the program with the most probable Phase 3 design. Discussions with the FDA have provided a clear pathway to lifting the clinical hold before the end of year. - Announced data in acute mdx model of Duchene’s Muscular Dystrophy (DMD) and formed
DN02, Inc. a wholly owned subsidiary to facilitate partnering and development of DN-TNF in the treatment of DMD. Results from the long-term D2.mdx model are expected soon. Data presented to date suggests DN-TNF may improve treatment from boys with DMD by promoting muscle fiber regeneration and eliminating the need for corticosteroids. Corticosteroids, the current standard-of-care, is responsible for many of the metabolic and physical complications suffered by boys with DMD. - Presented additional data on combination of INB03™ DN-TNF with trastuzumab-deruxtecan (Enhertu™, TDxd) at the
American Association for Cancer Research (AACR) annual scientific meeting in April showing that triple negative breast cancer (TNBC) often express MUC4. MUC4 expressing cancers, breast cancer, HER2+ breast cancer, TNBC, gastric and pancreatic cancer, are candidates for combination therapy with DN-TNF. In pre-clinical models, INB03™ DN-TNF reduced MUC4 expression to decrease resistance to immunotherapy including tyrosine kinase inhibitors (TKIs), trastuzumab and TDxd. The Company is developing a novel DN-TNF-bioconjugate compound with distinct intellectual property protections and testing in a variety of animal models in preparation of launching a strategic partnering program in oncology. - Announced pre-clinical, mouse model data that support the use of XPro™ as an early treatment following Traumatic Brain Injury (TBI) to prevent the development of amyloid pathology. Data shows neuroinflammation drives the development of amyloid pathology after TBI and can be prevented by neutralizing sTNF with XPro™. These data implicated TBI as a contributing factor for the development of AD.
INKmune™ Platform:
- IND filed in April for the use of INKmune™ to treat patients with metastatic castration-resistant prostate cancer (mCRPC) in the US. Excluding skin cancer, prostate cancer is the most common cancer in men. The Phase I/II design will enroll patients at several medical centers in the US.
- Additional sites have opened to support the ongoing Phase 1 trial in high risk MDS/AML. A second site in the
UK ,The Royal Hallamshire Hospital atSheffield University Medical School treated their first patient onMarch 9th . A third site inEurope ,Attikon University Hospital inAthens, Greece , has opened for recruitment and INKmune™ is being imported intoGreece in readiness for patient enrollment. - Our CSO
Mark Lowdell co-hosted a session at the Innate Killer Summit in La Jolla in March focused on the expanding world of memory-like NK cells in cancer immunotherapy and the ability of INKmune™ to generate these cells in vivo. - On
June 1 st,Dr Lowdell will present the opening plenary presentation in the Presidential Session at the annualInternational Society of Cell & Gene Therapy (ISCT) where he will share the latest data on INKmune.
Upcoming Events and Milestones:
- Top-line results for the Phase 2 XPro™ trial for treatment of neuroinflammation as a cause of Alzheimer’s Disease is expected in 2H 2024.
- Initiate a Phase 2 trial of XPro™ in patients with Treatment Resistant Depression that is partially funded by a
$2.9 million NIH grant upon resolution of the FDA manufacturing review. - Additional open-label Phase 1 trial data of INKmune™ in high-risk MDS/AML in 2023.
- Opening of a Phase I/II trial studying INKmune™ in prostate cancer upon the acceptance of the IND by the FDA.
Financial Results for the Quarter Ended March 31, 2023:
Net loss attributable to common stockholders for the quarter ended
Research and development expense totaled approximately
General and administrative expenses were approximately
Other expense was approximately
In addition, the Company received research and development rebates from
As of
As of
Earnings Call Information
To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio First Quarter Conference Call when reaching an operator.
Date:
Time:
Conference ID: 10177985
A live audio webcast of the call can be accessed using this link or clicking here:
https://callme.viavid.com/?$Y2FsbG1lPXRydWUmcGFzc2NvZGU9JmluZm89Y29tcGFueSZyPXRydWUmYj0xNQ==
A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through
About XPro™
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 website.
About INKmune™
INKmune™ is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient’s resting NK cells into tumor killing memory-like NK cells. INKmune™ treatment’s effect on NK cells is akin to treatment with at least three cytokines in combination (IL-12, IL-15, IL-18) to form memory-like NK cells. In patients, INKmune™ primed tumor killing NK cells persist for more than 100 days and function in the in the hypoxic TME because due to upregulated nutrient and mitochondrial survival proteins. INKmune™ is a patient friendly therapy that can be easily transported, stored and delivered to the patient by a simple intravenous infusion without the need for patient conditioning or premedication. INKmune™ is tumor agnostic; it can be used to treat many types of NK-resistant tumors including leukemia, lymphoma, myeloma, lung, ovarian, breast, renal and nasopharyngeal cancer. INKmune™ is treating patients in an open label Phase I trial in high-MDS/AML in the
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.
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 (XPro™), and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the
info@inmunebio.com
Investor Contact:
Core IR
(516) 842-9614 x-823
The following tables summarize our results of operations for the periods indicated:
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
2023 | 2022 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 51,003 | $ | 52,153 | ||||
| Research and development tax credit receivable | 1,814 | 8,099 | ||||||
| Other tax receivable | 396 | 362 | ||||||
| Prepaid expenses and other current assets | 3,633 | 4,027 | ||||||
| Prepaid expenses – related party | 35 | 34 | ||||||
| TOTAL CURRENT ASSETS | 56,881 | 64,675 | ||||||
| Operating lease – right of use asset | 485 | 507 | ||||||
| Other assets | 99 | 99 | ||||||
| Acquired in-process research and development intangible assets | 16,514 | 16,514 | ||||||
| TOTAL ASSETS | $ | 73,979 | $ | 81,795 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 2,077 | $ | 5,206 | ||||
| Accounts payable and accrued liabilities – related parties | 9 | 9 | ||||||
| Deferred liabilities | 591 | 616 | ||||||
| Current portion of long-term debt | 7,500 | 5,000 | ||||||
| Operating lease, current liabilities | 106 | 87 | ||||||
| TOTAL CURRENT LIABILITIES | 10,283 | 10,918 | ||||||
| Long-term debt, net | 7,264 | 9,697 | ||||||
| Long-term operating lease liabilities | 498 | 526 | ||||||
| Accrued liability – long-term | 638 | 550 | ||||||
| TOTAL LIABILITIES | 18,683 | 21,691 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Preferred stock, | - | - | ||||||
| Common stock, | 18 | 18 | ||||||
| Additional paid-in capital | 153,536 | 151,799 | ||||||
| Accumulated other comprehensive loss | (708 | ) | (699 | ) | ||||
| Accumulated deficit | (97,550 | ) | (91,014 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 55,296 | 60,104 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 73,979 | $ | 81,795 | ||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)
| Three months ended | ||||||||
| 2023 | 2022 | |||||||
| REVENUE | $ | 38 | $ | 163 | ||||
| OPERATING EXPENSES | ||||||||
| General and administrative | 2,328 | 2,332 | ||||||
| Research and development | 4,133 | 4,309 | ||||||
| Total operating expenses | 6,461 | 6,641 | ||||||
| LOSS FROM OPERATIONS | (6,423 | ) | (6,478 | ) | ||||
| OTHER EXPENSE | ||||||||
| Other expense, net | (113 | ) | (425 | ) | ||||
| Total other expense, net | (113 | ) | (425 | ) | ||||
| NET LOSS | $ | (6,536 | ) | $ | (6,903 | ) | ||
| Net loss per common share – basic and diluted | $ | (0.36 | ) | $ | (0.39 | ) | ||
| Weighted average number of common shares outstanding – basic and diluted | 17,945,995 | 17,870,285 | ||||||
| COMPREHENSIVE LOSS | ||||||||
| Net loss | $ | (6,536 | ) | $ | (6,903 | ) | ||
| Other comprehensive (loss) income – foreign currency translation | (9 | ) | 55 | |||||
| Total comprehensive loss | $ | (6,545 | ) | $ | (6,848 | ) | ||
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
| For the Three Months Ended | ||||||||
| 2023 | 2022 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (6,536 | ) | $ | (6,903 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 1,737 | 1,536 | ||||||
| Accretion of debt discount | 67 | 56 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | 6,285 | (236 | ) | |||||
| Other tax receivable | (34 | ) | 92 | |||||
| Prepaid expenses | 394 | (2,390 | ) | |||||
| Prepaid expenses – related party | (1 | ) | - | |||||
| Accounts payable and accrued liabilities | (3,129 | ) | (1,182 | ) | ||||
| Accounts payable and accrued liabilities – related parties | - | (71 | ) | |||||
| Deferred liabilities | (25 | ) | 110 | |||||
| Accrued liability – long-term | 88 | 88 | ||||||
| Operating lease liabilities | 13 | 35 | ||||||
| Net cash used in operating activities | (1,141 | ) | (8,865 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from sale of common stock | - | 699 | ||||||
| Net proceeds from the exercise of warrants | - | 30 | ||||||
| Net cash provided by financing activities | - | 729 | ||||||
| Impact on cash from foreign currency translation | (9 | ) | 55 | |||||
| (1,150 | ) | (8,081 | ) | |||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 52,153 | 74,810 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 51,003 | $ | 66,729 | ||||
2023 GlobeNewswire, Inc., source
