INmune Bio(INMB)
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INmune Bio(INMB) - 2021 Q4 - Annual Report
2022-03-03 21:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2021 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number: 001-38793 INMUNE BIO INC. (Exact name of registrant as specified in its charter) Nevada 47-5205835 (State or other jurisdiction of inco ...
INmune Bio(INMB) - 2021 Q3 - Earnings Call Transcript
2021-11-04 05:14
INmune Bio, Inc. (NASDAQ:INMB) Q3 2021 Earnings Conference Call November 3, 2021 4:30 PM ET Company Participants David Moss - Co-Founder and Chief Financial Officer R. J. Tesi - Chief Executive Officer and Co-Founder Mark Lowdell - Chief Scientific Officer and Co-Founder C. J. Barnum - Head, Neuroscience Conference Call Participants Tom Shrader - BTIG Operator Greetings and welcome to the INmune Bio Third Quarter 2021 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. A ...
INmune Bio(INMB) - 2021 Q3 - Quarterly Report
2021-11-03 20:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 INMUNE BIO INC. (Exact name of registrant as specified in its charter) Nevada 47-5205835 (State of incorporation) (I.R.S. Employer Identification No.) David Moss 225 NE Mizner Blvd., Su ...
INmune Bio(INMB) - 2021 Q2 - Earnings Call Transcript
2021-08-08 01:30
INmune Bio, Inc. (NASDAQ:INMB) Q2 2021 Results Conference Call August 4, 2021 4:30 PM ET Company Participants David Moss - Co-Founder and CFO Dr. RJ Tesi - CEO and Co-Founder Conference Call Participants Jonathan Aschoff - ROTH Capital Partners Mikhail Keyserman - BTIG Mayank Mamtani - B. Riley Securities Mark Lowdell - Chief Scientific Officer and Chief Manufacturing Officer Daniel Carlson - TW Research Operator Greetings, and welcome to the INmune Bio Second Quarter 2021 Earnings Call. [Operator Instructi ...
INmune Bio(INMB) - 2021 Q2 - Quarterly Report
2021-08-04 20:21
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 INMUNE BIO INC. (Exact name of registrant as specified in its charter) Nevada 47-5205835 Boca Raton, FL 33432 (Address of principal executive of ice) (Zip code) (858) 964-3720 (Registrant's ...
INmune Bio(INMB) - 2021 Q1 - Earnings Call Transcript
2021-05-06 03:42
Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for Q1 2021 was approximately $4.6 million, compared to approximately $2.0 million for the same period in 2020, indicating a significant increase in losses [38] - Research and development expenses totaled approximately $2.5 million for Q1 2021, up from approximately $800,000 in Q1 2020, primarily due to increased R&D activities related to clinical programs and drug supply manufacturing costs [38] - General and administrative expenses were approximately $2.1 million for Q1 2021, compared to $1.3 million for the same period in 2020 [39] - As of March 31, 2021, the company had cash and cash equivalents of approximately $45.3 million with no debt, including net proceeds of approximately $28.4 million raised through an ATM facility [39] Business Line Data and Key Metrics Changes - The Alzheimer's program focuses on XPro1595, which targets neuroinflammation, a core pathology in Alzheimer's disease, with promising data indicating improvements in both neuroinflammation and cognitive function [10][19] - The treatment-resistant depression program is supported by a $2.9 million NIH grant, with a substantial market of approximately seven million patients in the US suffering from TRD [24][26] - The COVID-19 program, utilizing the drug Quellor, aims to address cytokine storms in hospitalized patients, with a trial designed to enroll 366 high-risk patients [27] Market Data and Key Metrics Changes - The treatment-resistant depression market is estimated to exceed $64 billion annually in the US healthcare system, highlighting a significant need for therapeutic advancements [24] - The company is currently screening patients for the INKmune study in high-risk myelodysplastic syndrome (MDS), which is a serious hematopoietic stem cell disorder [31] Company Strategy and Development Direction - The company aims to initiate a Phase 2 trial for Alzheimer's disease with XPro1595 by the end of the year, focusing on neuroinflammation as a treatment target [40] - The strategy includes leveraging biomarker data to enhance patient selection and trial design for both Alzheimer's and treatment-resistant depression programs [45][56] - The company is committed to expanding its research into neuroinflammation across various CNS diseases, indicating a broad operational field beyond just Alzheimer's [23] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the future of the XPro1595 program, citing compelling data from ongoing trials and the potential for broader applications in neurodegenerative and psychiatric diseases [22][99] - The management acknowledged the challenges posed by the COVID-19 pandemic but emphasized progress in their neuroinflammatory franchise and upcoming milestones [42][43] Other Important Information - The company plans to provide further clarity on the design and timeline of the Phase 2 trial for Alzheimer's disease as it approaches the milestone [40] - The INB03 oncology program has been delayed due to COVID-19, with hopes to initiate a Phase 2 trial once the pandemic is better controlled [36] Q&A Session Summary Question: What biomarker data can be expected in the final Phase 1 Alzheimer's data release? - Management indicated that the trial aims to define biomarkers for patient selection and provide indirect evidence of biological improvements in the brain, with a focus on cognitive endpoints for FDA approval [44][45] Question: How many patients will be included in the upcoming data disclosure? - Management anticipates having data from 17 to 24 patients for analysis, with additional biomarker data from patients in the extension trial [51][52] Question: Will the Phase 2 study design include any prognostic biomarkers? - Management confirmed that the trial will focus on neuroinflammation and will utilize biomarkers such as CRP and white matter free water for patient selection [56] Question: How will the company prioritize mental health-related diseases like TRD? - Management stated that the company follows scientific evidence and funding opportunities, emphasizing that their approach is driven by sound science rather than investor interest [76][77] Question: Is there any insight on the long-term safety of XPro for patients? - Management confirmed that patients have remained on the drug for up to 12 months without safety issues, and they are exploring additional delivery methodologies [94][95]
INmune Bio(INMB) - 2021 Q1 - Quarterly Report
2021-05-05 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2021 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 INMUNE BIO INC. (Exact name of registrant as specified in its charter) Nevada 47-5205835 (State of incorporation) (I.R.S. Employer Identification No.) David Moss 1200 Prospect Street, Suite ...
INmune Bio(INMB) - 2020 Q4 - Earnings Call Transcript
2021-03-05 03:17
Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for the year ended December 31, 2020, was approximately $12.1 million, compared to approximately $7.7 million for the year ended December 31, 2019 [32] - Research and development expenses totaled approximately $5.9 million for the year ended December 31, 2020, compared to approximately $3.3 million for the year ended December 31, 2019, primarily due to increased R&D activities related to clinical programs and manufacturing additional drug supply [32] - General administrative expenses were approximately $6.3 million for the year ended December 31, 2020, compared to $6 million for the year ended December 31, 2019 [33] - As of December 31, 2020, the company had cash and cash equivalents of approximately $22 million with no debt [33] Business Line Data and Key Metrics Changes - The company is developing XPro1595 for Alzheimer's disease and other CNS indications, with interim data showing a 40% reduction in neuroinflammation in a small preliminary data set [9][10] - In a phase 1 trial, 8 out of 9 patients were stable or had improved cognition over a three-month period, indicating potential efficacy of XPro1595 [17] - A phase 2 trial for treatment-resistant depression (TRD) is planned, supported by a $2.9 million NIH grant, leveraging insights from the Alzheimer's program [21][23] Market Data and Key Metrics Changes - The company plans to initiate a phase 2 trial of XPro1595 in treatment-resistant depression, targeting a subset of patients with biomarkers of inflammation [40] - The U.S. has an estimated 7 million patients with major depressive disorder resistant to current therapies, highlighting a significant unmet need in the market [24] Company Strategy and Development Direction - The company aims to start a blinded randomized placebo-controlled phase 2 clinical trial for XPro1595 in Alzheimer's disease in the second half of 2021 [19] - The strategy includes using biomarkers to improve the efficiency of drug development in psychiatric conditions, with a focus on neuroinflammation as a common pathology across various diseases [23][25] - The company is also exploring additional clinical programs in oncology and NASH, pending the resolution of COVID-19 related restrictions [31][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made in the neuroinflammation franchise, particularly following the compelling Alzheimer's disease data reported in January [36] - The company is closely monitoring the role of neuroinflammation in long COVID, indicating potential future research opportunities [59] Other Important Information - The company raised gross proceeds of approximately $28.4 million through its at-the-market facility, issuing 1,439,480 shares of common stock at a price of $20.17 [33] - The company plans to provide more clarity on the design and costs of the phase 2 trial for Alzheimer's disease as it approaches the milestone [35] Q&A Session Summary Question: Will the phase 1b trial see more patients or deeper analyses? - Management confirmed that both more patients and longer follow-up times will be included in the phase 1b trial [38] Question: How does the company view treatment-resistant depression (TRD) patients? - Management indicated that they will focus on TRD patients with biomarkers of inflammation, suggesting a subset of approximately one-third of TRD patients [40] Question: Are there different neuroinflammation biomarkers for TRD compared to Alzheimer's? - Management confirmed the use of a unique connectivity biomarker for TRD patients, alongside standard MRI biomarkers [44] Question: What additional data should be expected from the phase 1b Alzheimer's program? - Management mentioned exploring doses between current cohorts and emphasized the importance of determining the right dose before moving to phase 2 [50] Question: Will the Quellor trial have any impact on long COVID? - Management acknowledged the potential link between neuroinflammation and long COVID, indicating ongoing interest in this area [59] Question: How many patients have passed the 12-week period in the trial? - Management reported that all patients in the high-dose group have enrolled in the extension trial, with some already reaching their one-year anniversary [62]
INmune Bio(INMB) - 2020 Q4 - Annual Report
2021-03-04 21:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2020 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number: 001-38793 INMUNE BIO INC. (Exact name of registrant as specified in its charter) Nevada 47-5205835 (State or other jurisdiction of inco ...
INmune Bio(INMB) - 2020 Q3 - Earnings Call Transcript
2020-11-08 09:24
INmune Bio, Inc. (NASDAQ:INMB) Q3 2020 Earnings Conference Call November 5, 2020 4:30 PM ET Company Participants RJ Tesi - Co-Founder and CEO David Moss - Co-Founder and CFO Conference Call Participants Jonathan Aschoff - ROTH Capital Partners Julian Harrison - BTIG Jason McCarthy - Maxim Group Michael Irwin - Univest Security Operator Greetings, and welcome to the INmune Bio Third Quarter 2020 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. A transcript will follow ...