On May 15, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company developing treatments that harness the patient’s innate immune system to fight disease reported its financial results for the first quarter ended March 31, 2020 and is providing a business update (Press release, INmune Bio, MAY 15, 2020, View Source [SID1234558124]). INmune Bio will hold a conference call today at 4:30 PM Eastern Time. To participate in the call, please dial 201-389-0923 five minutes before the schedule time.
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The company will review the progress on its clinical programs in areas including Alzheimer’s disease and its recently announced effort in combating complications of COVID-19. The company will also provide guidance for development efforts over the next two quarters based on the ongoing pandemic.
"Since our last earning report, we have been working to put our COVID-19 trial in place," said RJ Tesi MD, Chief Executive Officer of INmune Bio. "Additionally, our Alzheimer’s disease program continues to move forward in Australia. We are comfortable with our goal to have data from the Alzheimer’s program in October if not sooner."
Q1 2020 and Recent Corporate Highlights on the DN-TNF Platform and NK Priming Platform:
DN-TNF Platform Highlights:
Announced combination therapy of Lapatinib with INB03 will be used in the planned Phase II INB03 program in women with brain metastasis from HER2+ breast cancer.
Announced initiation of clinical program targeting soluble TNF (Quellor), one of the key components of the cytokine storm, using its TNF Inhibitor (DN-TNF) Platform to prevent complications of COVID-19 infection.
Expects to submit IND for Quellor in May 2020.
Frontiers in Oncology published an invited review highlighting soluble TNF’s impact on breast cancer.
Awarded a $500,000 grant from The ALS Association to complete IND enabling pre-clinical studies with XPro1595 as a therapy for ALS.
Enrollment continues in the XPro1595 Phase 1 study to evaluate neuroinflammation in patients with Alzheimer’s disease and is on track to report data in October if not earlier.
NK Priming Platform Highlights:
Announced allowance of U.S. Patent covering method for treating cancer by in vivo priming of natural killer cells.
Received notice of allowance in counterpart patent in Australia covering method for treating cancer by in vivo priming of natural killer cells.
"First quarter and year to date, has been a period of considerable progress," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "Our Alzheimer’s trial continues to enroll and we expect to have data in October if not earlier. We received funding to perform pre-clinical proof-of-concept studies in ALS, announced a plan to initiate a multinational clinical program to determine if our DN-TNF platform will help prevent complications of cytokine storm caused by COVID-19 that will enroll patients in the US and Australia and we solidified our unique approach to the treatment of trastuzumab resistant HER2+ breast cancer. Additionally, we received a patent allowance for our NK Priming Platform, and we were published in a Frontiers in Oncology invited review, underscoring sTNF’s effect on breast cancer. In summary, we continue to increase the value of our two platform technologies, with an ever-widening range of applications to advance the breadth and depth of our clinical programs."
Upcoming Milestones:
Report results of Phase 1 XPro1595 in Alzheimer’s Disease, expected to complete 2H 2020.
Submit IND for Quellor for the prevention of complications of COVID-19 infection, expected in May 2020.
Enroll first patient in Phase II Quellor program, targeting COVID-19 patients with complications from COVID19 as soon as possible.
The following milestone timelines have been updated due to the ongoing COVID-19 pandemic.
Enroll first patient in Phase II INB03 program, targeting trastuzumab resistant HER2+ breast cancer using INB03 as part of combination therapy, expected mid-2021.
Enroll first patient in Phase II LIVNate for NASH, expected mid-2021.
Enroll first patient in Phase I INKmune in High Risk MDS cancer, expected 2H20.
Enroll first patient in Phase I INKmune in Ovarian cancer, expected mid-2021.
Financial Results for the First Quarter Ended March 31, 2020:
Net loss attributable to common stockholders for the first quarter ended March 31, 2020 was $2.1 million, compared to $1.9 million for the quarter ended March 31, 2019.
Research and development expense totaled approximately $0.8 million for the first quarter ended March 31, 2020, compared with approximately $0.6 million for the quarter ended March 31, 2019.
General and administrative expense was approximately $1.3 million in each of the quarters ended March 31, 2020 and March 31, 2019.
As of March 31, 2020, the Company had cash and cash equivalents of approximately $5.9 million with no debt.
As of May 14, 2020, the Company had approximately 10.8 million common shares outstanding.
Earnings Call Information
To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.
Date: May 14, 2020
Time: 4:30 PM Eastern Time
Participant: 201-389-0923
About XPro1595
XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that acts differently than currently existing TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. 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 XPro1595 Clinical Trial
XPro1595 is currently being evaluated in Phase Ib clinical trial in Alzheimer’s disease patients who have biomarkers of neuroinflammation to determine if neutralizing soluble TNF can decrease those biomarkers of neuroinflammation.
Adults (>18 years old) diagnosed with probable Alzheimer’s disease defined by the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer’s Disease and Related Disorders Association criteria, confirmed with inflammatory biomarkers are being enrolled in this multicenter, Phase Ib open-label study. The study will follow patients during a twelve-week period to determine the safety and the ability of XPro1595 to reduce neuroinflammation using a combination of biomarkers of inflammation. The study will examine inflammatory and disease-related biomarkers before treatment, at the halfway point, and at the end. Cognitive and neuropsychiatric symptoms will be also be measured during the trial. The study will identify the dose of XPro1595 to be used in a larger Phase II disease modification study.
Clinical sites are located in Australia and include KaRa MINDS in New South Wales, Central Adelaide Local Health Network in South Australia, Austin Health and Alfred Health in Victoria, and The Australian Alzheimer’s Research Foundation in Western Australia.