On March 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 year ended December 31, 2021 and provided a business update (Press release, INmune Bio, MAR 3, 2022, View Source [SID1234609522]).
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!
In December, the Company reported data from the first patient treated with INKmuneTM in the myelodysplastic syndrome (MDS) Phase I clinical trial. More than 100 days after the course of INKmuneTM therapy, 60% of the patient’s NK cells showed the activated, tumor killing memory like NK cells phenotype, a fourfold increase from pre-treatment. The patient’s memory like NK cells killed >70% of NK resistant tumor cells in an in vitro assay. The patient remains well and with an ECOG status of 0, a two-point drop from pre-treatment. Additionally, two patients were treated with INKmuneTM under compassionate use after having failed at least one allogeneic bone marrow transplant. One of the two patients has been discharged home, one remains hospitalized. In all cases, INKmuneTM therapy was well tolerated, safe and was given without any type of pre-medication or cytokine therapy.
"These patients demonstrate the unique attributes of INKmuneTM therapy in patients with high-risk MDS/AML. INKmuneTM converted the patient’s resting NK cells into cancer killing memory like NK cells. The memory like NK cells killed NK-resistant cancer cells in an in vitro assay. Both these attributes lasted four months, a trait we are calling therapeutic persistence." stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "We are continuing to screen patients for enrollment into the trial and are in process of expanding the number of clinical trial sites."
The Phase II clinical trial using XProTM to treat patients with AD and elevated biomarkers of neuroinflammation (ADi) is open, screening patients and seeking to enroll the first patient. A second Phase II trial in patients with Mild Cognitive Impairment (MCI) should begin enrolling patients soon. Patients must have ApoE4 to be included in the MCI trial. INMB is treating MCI and Mild AD in separate clinical trials due to differences in disease severity with the potential for different rates of response to therapy. The MCI trial is a three-month trial designed to determine the extent to which XProTM has an impact on biological and cognitive biomarkers in MCI patients. The mild AD trial is a six-month trial with EMACC as the primary endpoint and secondary endpoints of CDR, ADL, NPI, MRI, and blood biomarkers of neurodegeneration. Top line data is expected in the first half of 2023 from the MCI trial and the second half of 2023 from the mild ADi trial. A video released today can be found on the company’s website which explains our rationale for XPro in treating neuroinflammation to potentially reduce white and gray matter degeneration which can be found by clicking here.
Q4 2021 and Recent Corporate Highlights
IINKmuneTM Platform Highlights:
The Phase I program has been peer-reviewed by the UK National Cancer Research Institute (NCRI) – Myelodysplastic Syndrome Expert Group and has been accepted for listing on their national MDS trials site. This is unique to the UK; no equivalent system is present in the US. This allows specialist MDS trials centers to refer patients to the current UK clinical trial sites for treatment under the clinical trial protocol or to request to become an additional trial site. We hope this added validation of the trial and exposure to additional expert centers will provide more patients for enrollment into the Phase I MDS program and facilitate future phase II trials.
Presented 119-day data on first patient in company’s ongoing Phase 1 clinical trial of its Natural Killer (NK) cell priming platform, INKmuneTM, as a potential treatment for high-risk myelodysplastic syndrome (MDS). A single course of INKmuneTM has benefited the course the patient’s disease for more than 6 months. The data were presented at the 2021 British Society of Immunology Congress.
Announced a pre-clinical research collaboration with the Chinese University of Hong Kong to evaluate INKmuneTM, the company’s pseudokine NK cell priming platform, in nasopharyngeal cancer (NPC), a type of head and neck cancer. The project provides INMB scientists working at University College of London with access to the only three proven NPC cancer cell lines to test the ability of INKmuneTM-primed NK cells to kill NPC tumors. This pre-clinical work, if successful, will provide data for a future clinical trial in NPC.
DN-TNF Platform Highlights (XProTM and INB03TM):
Opened the Phase II trial using XProTM to treat patients with mild ADi for enrollment. 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.
Delivered multiple oral and poster presentations at the AAIC 2022 (Alzheimer’s Association International Conference) and the 14th Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting.
Presented new breast cancer data at the 2021 San Antonio Breast Cancer Symposium. A significant percentage of women with triple negative breast cancer (TNBC) express MUC4. MUC4 expression predicts a worse survival and increased risk of developing metastatic disease. In addition, MUC4 expressing patients have "cold" tumors with fewer tumor infiltrating lymphocytes. These data suggest the use of INmune’s DN-TNF candidate, INB03TM, may help reverse resistance to immunotherapy women with TNBC.
Upcoming Milestones:
Initiate XProTM Phase II program for Mild Cognitive Impairment (MCI) in patients with APOE4 allele 1H 2022.
Initiate XProTM Phase II program for treatment resistant depression (TRD), funded in part by a $2.9 million NIH grant, by 2H 2022.
Initiate INKmune Phase I program in ovarian cancer in 2H 2022.
Additional open-label Phase 1 trial data of INKmuneTM in high-risk MDS.
Report top-line data from Phase 2 trial of XProTM in MCI patients in 1H 2023.
Report top-line data from Phase 2 trial of XProTM in mild Alzheimer’s patients in 2H 2023.
Present INKmuneTM clinical data and new pre-clinical data on mechanism of action at the Innate Killer Summit conference in San Diego in March.
Report pre-clinical INKmuneTM data in at least two new solid tumor indications, renal cell carcinoma and nasopharyngeal carcinoma.
Oral and Poster presentations at AD/PD 2022, the largest European AD meeting. The meeting will be held in Barcelona in March.
Financial Results for the Year Ended December 31, 2021:
Net loss attributable to common stockholders for the year ended December 31, 2021 was approximately $30.3 million, compared to approximately $12.1 million for the year ended December 31, 2020.
Revenues were approximately $0.2 million for the year ended December 31, 2021, compared to $0.0 million for the year ended December 31, 2020.
Research and development expense totaled approximately $20.5 million for the year ended December 31, 2021, compared to approximately $5.9 million during the year ended December 31, 2020.
General and administrative expense was approximately $8.8 million for the year ended December 31, 2021, compared to approximately $6.3 million during the year ended December 31, 2020.
Other expense was approximately $1.2 million during the year ended December 31, 2021 compared to other income of approximately $0.1 million during the year ended December 31, 2020.
As of December 31, 2021, the Company had cash of approximately $74.8 million.
As of March 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.
A live audio webcast of the call can be accessed using this link: View Source;tp_key=636ec61ab2
A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through March 10, 2022 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13726701.
About XProTM
XProTM is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently existing TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XProTM could have 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 INKmuneTM
INKmune is a pharmaceutical-grade, replication-incompetent derivative of our proprietary INB16 cell line, a human tumor cell line, which conjugates to resting NK cells and delivers multiple essential priming signals akin to treatment with a combination of at least three cytokines. INKmuneTM is stable at -80 °C and is delivered by a simple IV infusion. The INKmuneTM: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 tumor lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors, including: leukemias, lymphomas, myeloma, ovarian cancer, and breast cancer.