On August 3, 2022 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, 2022 and provides a business update (Press release, INmune Bio, AUG 3, 2022, View Source [SID1234617515]).
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Q2 2022 and Recent Corporate Highlights
DN-TNF Platform Highlights (XPro and INB03):
Dosed the first patient in the Phase II trial using XPro (XPro1595) to treat patients with mild Alzheimer’s Disease (AD) in April. The primary endpoint will examine cognition using the Early AD/MCI Alzheimer’s Cognitive Composite (EMACC). Multiple secondary endpoints of cognition will also be measured, including CDR-SB, ADAS-COG13 and other endpoints. Data is anticipated in the second half of 2023.
FDA review of Chemistry Manufacturing and Controls (CMC) associated with a recently placed clinical hold on XPro1595 AD trials is ongoing. The Company is addressing the FDA’s manufacturing procedure query to alleviate the current hold and start the US trials sites for XPro1595 in AD as a soon as possible. While trials in the United States are on hold, INmune continues to enroll and open additional treatment sites in Australia.
INmune completed the manufacture of new doses of XPro during the quarter, enough to supply all Phase 2 programs and continue the expansion of our pre-clinical research in new disease targets for XPro therapy.
The Company presented data demonstrating XPro promotes remyelination in white matter in rodent models of Multiple Sclerosis at European Conference on Neuroinflammation.
INB03 – presented data at the AACR (Free AACR Whitepaper) Conference and HER2+ Targeted Therapy Summit showing INB03’s ability to reverse Mucin 4 (MUC4) expression, a negative predictor of treatment success, in HER2 breast cancer cell line (JIMIT-1) to re-establish sensitivity to trastuzumab and tyrosine kinase inhibitors.
Patent issued for use of XPro for central nervous systems diseases: "METHODS OF TREATING NEUROLOGICAL DISEASES," a patent directed to use of Dominant Negative Tumor Necrosis Factor variants, such as the Company’s XPro, by peripheral administration for crossing the blood-brain barrier and treating diseases of the Central Nervous System. This patent provides protection for XPro treatment in CNS diseases to 2033 with possible patent term extension of up to five additional years if requested by the Company and approved by the USPTO under 35 U.S.C. 156.
INKmune Platform:
The Company continues to monitor the high-risk myelodysplastic syndrome (MDS) cancer patient and the two compassionate use acute myeloid leukemia (AML) patients who have been treated with INKmune in a Phase 1 open label dose escalation trial.
Two weeks ago, a young patient with refractory AML after failed BMT was treated with INKmune. She received three doses of INKmune without side effects. We will be monitoring her progress closely. She is another patient with a high level of disease burden.
Received national registration for the INKmune MDS trial in the UK which allows for patients from any hospital to be enrolled in the trial at Southampton University Hospital. Additionally, the Company will be expanding its INKmune MDS trial into the EU with a new site in Athens, Greece.
Expanded ongoing INKmune treatment in MDS Phase 1 trial to include patients with AML. The Company has recently treated a new patient with AML on a compassionate basis who failed the inclusion criteria for AML patients in the trial.
Upcoming Milestones:
Initiate Xpro Phase 2 program for AD02 (mild AD) and AD03 (mild cognitive impairment) in US patients once clinical hold is lifted.
Initiate XPro Phase 2 program for treatment resistant depression (TRD), funded in part by a $2.9 million NIH grant, once clinical hold is lifted.
Initiate INKmune Phase I program in a solid tumor in 1H 2023.
Additional open-label Phase 1 trial data of INKmune in high-risk MDS/AML by 1H 2023.
Report top-line data from Phase 2 trial of Xpro in AD03 patients in 2H 2023.
Report top-line data from Phase 2 trial of XPro in AD02 patients in late 2023 or early 2024.
Report pre-clinical INKmune data in at least two new solid tumor indications, renal cell carcinoma and nasopharyngeal carcinoma.
"In April, we announced the dosing of our first patient treated with XPro1595 in the treatment of neuroinflammation as a cause of mild Alzheimer’s disease (AD) in Phase II clinical trial, AD02," stated RJ Tesi, M.D., CEO of INmune Bio. "The trial is a blinded, randomized, placebo-controlled multicenter study in Australia, in Canada and in the United States. Although the trial in the United States is currently on hold pending conclusion of the FDA’s manufacturing inquiry, we continue to enroll patients in Australia where the trial is proceeding as planned. Additionally, our plan to launch additional blinded, randomized, placebo-controlled Phase II trials in patients with mild cognitive impairment (MCI) and TRD will occur after the clinical hold is lifted.
"Our INKmune platform continues to make positive strides. We are actively expanding the INKmune program towards the treatment of solid tumors. INKmune primed NK cells have unique biologic characteristics that should make the therapy effective in solid tumors," concluded Dr. Tesi.
Financial Results for the Quarter Ended June 30, 2022:
Net loss attributable to common stockholders for the quarter ended June 30, 2022 was approximately $6.8 million, compared to approximately $6.7 million for the quarter ended June 30, 2021.
Research and development expense totaled approximately $4.2 million for the recent quarter compared to approximately $4.5 million during the quarter ended June 30, 2021.
General and administrative expense was approximately $2.2 million for the quarter compared to approximately $2.1 million during the quarter ended June 30, 2021.
Other expense was approximately $0.5 million for the quarter ended June 30, 2022 compared to approximately $ 0.1 million during the quarter ended June 30, 2021.
As of June 30, 2022, the Company had cash and cash equivalents of approximately $61.2 million.
As of August 3, 2022, the Company had approximately 17.9 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: August 3, 2022
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-407-0784
Participant Dial-in (international): 1-201-689-8560
Conference ID: 13728540
A live audio webcast of the call can be accessed using this link: View Source
A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 10, 2022 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13728540.
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 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.