On August 2, 2024 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage inflammation and immunology company developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the quarter ended June 30, 2024 and provides a business update (Press release, INmune Bio, AUG 2, 2024, View Source [SID1234645302]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Q2 2024 and Recent Corporate Highlights

DN-TNF Platform Highlights (XPro):

● The Phase 2 randomized, blinded clinical trial for patients with Early Alzheimer’s Disease is on schedule to reach its final enrollment before the end of Q3 followed by top-line data approximately six months from the last patient enrolled.

● Announced completion of blinded interim analysis of the ongoing Phase II Alzheimer’s Disease trial, confirming that the trial is appropriately powered to assess its primary and secondary cognitive endpoints, the Early Mild Alzheimer’s Cognitive Composite (EMACC) and CDR. The third-party evaluation concluded that the trial design, operational execution, data collection, and management are of the highest quality.

● New Phase 1b analysis of proteomic data presented at AAIC shows XPro’s significant effects on a broad range of synaptic proteins and pathways. The analysis revealed that a 12-week treatment with XPro resulted in a significant change in synaptic proteins, which are essential for communication between neurons. The formation and elimination of synapses is executed by cells of the innate immune system such as astrocytes. When these cells are in a dysregulated inflammatory/immune state, synapse formation is reduced and synapse elimination is increased, resulting in loss of communication between neurons which, in the case of AD, results in cognitive impairment. Restoring synapses requires a normally functioning innate immune system.

● The Company successfully completed extended stability validation for XPro at continuous storage in solution at 2C-8C. The 24 and 30-month stability test samples passed all chemistry and potency assays allowing the Company to make a conservative claim of 24-month stability and positioning it to meet the dosing demands envisioned in the Phase III trial.

● Shared the progress of two early patients in the Phase 1b AD trial in Australia who have continued to receive XPro treatment under an open-label program administered by their treating physician. The video testimonials underscore XPro’s unique attributes that may halt progression of cognitive impairment versus existing treatments that slow the pace of, but do not stop the progression of, cognitive decline.

INKmune Platform:

● Announced a new formulation of INKmune that supports single bag administration at the highest trial dose, and expansion of bioreactor capacity in preparation of scalable manufacturing. An IND amendment with the improved formulation has been submitted to the FDA that also includes additional validation data supporting an alternative critical reagent used in INKmune manufacturing, improving supply chain redundancy.

● Completed the first cohort in the Phase I/II open label trial (the "CarePC" trial) of INKmune in metastatic castration-resistant prostate cancer (mCRPC). Following review by the Safety Review Committee (SRC), approval was granted to proceed with the second dose level (cohort 2) and two patients have been enrolled. Data from this open-label trial is expected to be released intermittently as it becomes available.

● Patient enrollment in CarePC remains robust and on schedule. The first patient of the middle dose cohort will complete treatment this month and the 2nd patient of the middle dose cohort is about to be screened. The safety of INKmune remains excellent and all patients in the CarePC trial have been treated as an out-patient. Data from the trial is expected to be released later this year.

● The most recent pre-clinical data and early clinical results with INKmune have been published in the peer-reviewed Journal for ImmunoTherapy of Cancer this month. The study demonstrates that memory-like natural killer (mlNK) cells, generated by either cytokine or INKmune priming, show increased cytotoxicity against multiple tumor types, offering promising potential for cancer immunotherapy. Importantly, while most studies are conducted on NK cells from healthy volunteers, this study demonstrated that mlNK from cancer patients are equally as potent as those generated from healthy volunteers, further supporting INKmune’s in vivo treatment methodology. The research also provides new insights into the metabolic and physiological mechanisms underlying NK cell memory, paving the way for innovative treatments in both hematological malignancies and solid tumors.

Corporate:

● The Company is presenting at BTIG’s Virtual Biotechnology Conference 2024 on Tuesday, August 6, 2024 at 8AM ET and will host one-on-one meetings August 5/6. This conference is being hosted by BTIG, a global financial services firm specializing in institutional trading, investment banking, research and related brokerage services. To join the conference, email.

● Joined the broad-market Russell 3000 Index at the conclusion of the 2024 Russell US Indexes annual reconstitution, effective as of Monday, July 1st, 2024.

● The Company successfully raised a combined $14.5 million of equity capital before placement agent fees and expenses in two separate transactions in late April. Of note, in the first $4.8 million offering, management and members of the Board of Directors purchased approximately 20% of the offering. Excluding shares and warrants acquired by insiders, both offerings were priced at-the-market.

● Received a research and development rebates from Australia in July of approximately $2.5 million USD.

Upcoming Events and Milestones:

● Full enrollment in the Phase II XPro trial for treatment of neuroinflammation as a cause of Alzheimer’s Disease is expected before the end of Q3 followed by top-line data approximately six months from the last patient enrolled.

● Initiate a Phase II trial of XPro in patients with Treatment-Resistant Depression 2H 2024.

● Expect to complete enrollment in the Phase I portion of INKmune in metastatic castration-resistant prostate cancer trial in Q4 2024. The Phase II portion is expected to complete enrollment in Q2, 2025, however we expect to provide periodic updates on the immunologic and therapeutic response to INKmune as data becomes available.

Financial Results for the First Quarter Ended June 30, 2024:

● Net loss attributable to common stockholders for the quarter ended June 30, 2024 was approximately $9.7 million, compared to approximately $6.5 million during the quarter ended June 30, 2023.

● Research and development expenses totaled approximately $7.1 million for the quarter ended June 30, 2024, compared to approximately $4.1 million during the quarter ended June 30, 2023.

● General and administrative expenses were approximately $2.8 million for the quarter ended June 30, 2024, compared to approximately $2.3 million during the quarter ended June 30, 2023.

● Other income (expense), net was approximately $0.1 million for the quarter ended June 30, 2024, compared to approximately ($0.1) million during the quarter ended June 30, 2023.

● As of June 30, 2024, the Company had cash and cash equivalents of approximately $31.1 million.

● As of August 1, 2024, the Company had approximately 19.8 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 Second Quarter Conference Call when reaching an operator.

Date: August 1, 2024
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-225-9448
Participant Dial-in (international): 1-203-518-9708
Conference ID: INMUNE

A live audio webcast of the call can be accessed by clicking here or using this link:
View Source;tp_key=8a15b560a4

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 8, 2024, by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11156467.

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.