On August 7, 2023 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, reported its financial results for the quarter ended June 30, 2023 and provides a business update (Press release, INmune Bio, AUG 7, 2023, View Source [SID1234633975]).
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Q2 2023 Corporate Highlights:
DN-TNF Platform Highlights (XPro and INB03):
● AD02 blinded randomized program in patients with Early Alzheimer’s Disease (AD) continues to enroll in Australia and Canada. The company is actively pursuing other regulatory venues to expand the clinical trial footprint. Discussions with the FDA have provided a clear pathway to lifting the clinical hold before the end-of-year.
● Announced expansion of novel MRI biomarker data to include gray matter. Gray matter, the portion of the brain containing nerve cell bodies, has historically been the focus of Alzheimer’s disease research and drug development. Previous MRI biomarker analysis from patients receiving XPro for treatment of AD has demonstrated early changes in white matter that predict presence of neuroinflammation and response to XPro therapy. The new data, reported at the annual Alzheimer’s Association International Conference (AAIC) in Amsterdam, Netherlands in July, demonstrates improvement in gray matter in patients with AD. The results demonstrate a dose dependent enhancement in gray matter measures in the brain in AD patients treated with XPro. The data confirm that neuroinflammation affects white and gray matter of the brain. Treatment with XPro resulted in improvements in both white and gray matter microstructural elements that may predict improvements in cognition. The data further validate the biomarker package associated with the on-going Phase II trial in patients with Early AD.
● Presented data in early July at the 16th European Meeting on Glial Cells in Health and Disease in Berlin that show that XPro promotes remyelination by affecting astroglial and microglial biology. Myelin is a specialized lipid produced by oligodendrocytes that forms the myelin sheath of axons. Axons are the projections that allow neurons to communicate with each other and with other tissues such as muscle, skin, retina, nose, and the ear for sight, smell, and hearing respectively. An intact and healthy myelin sheath is necessary for axons to allow neurons to communicate with each other and work properly. Drug therapies to prevent demyelination are available, but there are no therapies that promote remyelination. Therapies that promote remyelination will be needed to effectively treat many neurodegenerative diseases and is increasingly recognized as part of the pathology associated with Alzheimer’s disease. The Company plans a webinar on highlighting the importance of remyelination therapy in patients with MS and AD before the end-of-year.
● Presented additional data on combination of INB03 with trastuzumab-deruxtecan (Enhertu, TDxd) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 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 reduced MUC4 expression to decrease resistance to immunotherapy including tyrosine kinase inhibitors (TKI), trastuzumab and TDxd. A pSar DN-TNF compound with new composition-of-matter IP is in animal testing in preparation for a strategic partnering program in oncology.
● The polysarcosine (pSar) DN-TNF program converts XPro from a single drug into a DN-TNF drug platform. Polysarcosine is a novel half-life extender that effectively replaces the PEG half-life extender used in XPro. The pSar program is an essential part of INmune Bio’s business development efforts. XPro has been designated for the CNS programs, including AD, TRD, ALS and other neurological diseases. The pSar program provides at least three new DN-TNF biologics that are eligible for composition-of-matter IP and have unique biologic characteristics that allow partnering DN-TNF opportunities beyond CNS, such as oncology (INB03), Duchenne’s Muscular Dystrophy (DMD), and other disease indications. Each drug is a novel DN-TNF compound that will require a unique development program.
INKmune Platform:
● IND cleared by the Food & Drug Administration (FDA) in May for INKmune for a Phase I/II open label trial in metastatic Castration-Resistant Prostate Cancer (mCRPC). The trial is expected to enroll the first of 30 patients in the final quarter of 2023. Patients will receive three infusions of INKmune as out-patient treatment during the six-month trial. Three doses of INKmune are being tested in a modified Bayesian Phase I/II trial to answer four questions:
● Is INKmune safe in patients with mCRPC?
● What dose of INKmune should be used in a blinded randomized pivotal trial in men with mCRPC?
● How long can the effects of INKmune be sustained, (Determined by measuring tumor killing NK cells in the blood called memory like NK cells).
● Is there a tumor response to INKmune therapy? Measures of tumor response include blood PSA and tumor DNA levels in the patient’s blood and PMSA PET scan. The results of the open label study should allow the Company to design a pivotable trial.
● LAUREL, the INKmune trial in high risk MDS and AML has opened a third clinical site in Athens, Greece. The site is screening patients and expects to enroll patients soon. Changing management of high risk MDS patients in the UK has resulted in screen failures. The cause of these screen failures has been identified and addressed to help increase recruiting of patient into LAUREL. The Company is seeking to modify the trial enrollment criteria to increase the pool of potential patients to drive recruitment.
● CSO Dr. Mark Lowdell gave the opening plenary presentation in the Presidential Session at the annual International Society of Cell & Gene Therapy (ISCT) where he presented the scientific discovery of INKmune and development to clinical trials. His talk highlighted that NK cells primed by INKmune have the ability to alter their phenotype to a cancer-killing population of memory-like NK cells that differ from single-cytokine or multiple-cytokine (IL-12, IL-15, IL-18) primed NK cells. This innovation avoids the cost and complications associated with cytokine therapy and produces NK cells ideally suited for attacking cancer.
Upcoming Events and Milestones:
● Top-line results for the Phase II XPro trial for treatment of neuroinflammation as a cause of Alzheimer’s Disease are expected towards the end of 2024.
● Initiate a Phase II trial of XPro in patients with Treatment-Resistant Depression upon resolution of the ongoing FDA manufacturing review.
● Webinar on using XPro to promote remyelination in AD and MS before end-of-year.
● Additional open-label Phase I trial data of INKmune in high-risk MDS/AML in 2023.
● Opening of a Phase I/II trial in a prostate cancer in the second half of 2023.
2
Financial Results for the Quarter Ended June 30, 2023:
● Net loss attributable to common stockholders for the quarter ended June 30, 2023, was approximately $6.5 million, compared to approximately $6.8 million during the quarter ended June 30, 2022.
● Research and development expenses totaled approximately $4.1 million for the quarter ended June 30, 2023, compared to approximately $4.2 million during the quarter ended June 30, 2022.
● General and administrative expense were approximately $2.3 million for the quarter ended June 30, 2023, compared to approximately $2.2 million during the quarter ended June 30, 2022.
● Other expense was approximately $0.1 million for the quarter ended June 30, 2023, compared to approximately $0.5 million during the quarter ended June 30, 2022.
● As of June 30, 2023, the Company had cash and cash equivalents of approximately $47.8 million.
● As of August 7, 2023, the Company had approximately 18.0 million common shares outstanding.
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: August 7, 2023
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-404-0784 Participant Dial-in (international): 1-201-689-8560 Conference ID: 13739436
A live audio webcast of the call can be accessed using this link or clicking here:
View Source;tp_key=3e16bba085
A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 14 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13739436.
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.