On November 2, 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 September 30, 2022 and provides a business update (Press release, INmune Bio, NOV 2, 2022, View Source [SID1234622804]).
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Q3 2022 and Recent Corporate Highlights
DN-TNF Platform Highlights (XPro and INB03):
●FDA review of Chemistry Manufacturing and Controls (CMC) associated with a recently placed clinical hold on XPro1595 AD trials is ongoing. The Company has addressed the FDA’s manufacturing procedure query and is in ongoing discussion to alleviate the current hold and start the US trials sites for XPro1595 in AD as a soon as possible.
●The Phase 2 trial in Mild AD patients continues to enroll in Australia. The first patient treated in the trial has completed the six-month study and has enrolled in the open label extension study.
●Opened a Special Access Scheme (SAS) in AUS for patients in the Phase I AD trial based on the demand from our patients that completed the 12-month extension trial.
INKmune Platform:
●The Company announced positive solid tumor data in multiple cancer lines resistant to natural killer (NK) killing that can be overcome with administration of INKmune by converting patient’s normal resting NK cells into potent memory-like NK cells that target solid tumors directly, even in the presence of immunosuppressive immunoregulatory cells and hypoxia associated with the tumor microenvironment (TME).
●The second UK clinical site is due to be initiated in November 2022 and a third UK site is under evaluation.
●The company completed a pre-IND discussion with the FDA and is preparing the IND to file with the FDA on a solid tumor indication.
Upcoming Events and 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 1/2 program in a solid tumor in 1H 2023.
●Additional open-label Phase 1 trial data of INKmune in high-risk MDS/AML in 2023.
●Report top-line data from Phase 2 trial of Xpro in AD03 patients. Timelines to be updated following resolution of FDA clinical hold.
●Report top-line data from Phase 2 trial of XPro in AD02 patients. Timelines to be updated following resolution of FDA clinical hold.
●Presentation at Society of Immunotherapy Conference (SITC) (Free SITC Whitepaper) on the use of DN-TNF to reshape the TME of trastuzumab resistant HER2+ breast cancer from a cancer protecting immunosuppressive TME to a TME that makes the tumor sensitive to immunotherapy.
●Presentation at San Antonio Breast Cancer Symposium (SABCS) demonstrating the addition of DN-TNF to Antibody Drug Conjugates (ADC) in HER2+ breast cancer improves the response of ADCs and suggests addition of DN-TNF may improve results in resistant tumors.
●Presentation of clinical data at ASH (Free ASH Whitepaper) (American Society of Hematology) from the INKmune trial.
"The 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."
"Our 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," concluded Dr. Tesi.
Two presentations 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 30, 2022:
Net loss 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.
Research 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.
General and administrative expense was approximately $2.4 million for the quarter compared to approximately $2.5 million during the quarter ended September 30, 2021.
Other expense was approximately $0.3 million for the quarter ended September 30, 2022 compared to approximately $0.4 million during the quarter ended September 30, 2021.
As of September 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.
Earnings Call Information
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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.