INmune Bio, Inc. (NASDAQ:INMB) Q1 2021 Earnings Conference Call May 5, 2021 4:30 PM ET Company Participants David Moss - Co-Founder & Chief Financial Officer RJ Tesi - Chief Executive Officer and Co-Founder Conference Call Participants Jonathan Aschoff - ROTH Capital Partners Mayank Mamtani - B. Riley Securities Jason McCarthy - Maxim Group Sung Nam - BTIG Michael Irwin - Univest Securities Daniel Carlson - Tailwinds Research Operator Greetings and welcome to the INmune Bio First Quarter 2021 Earnings Call. ...

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 ...

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]

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, 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 ...

PART I – FINANCIAL INFORMATION This section presents the company's unaudited consolidated financial statements and related disclosures for the specified periods [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited consolidated financial statements of INmune Bio, Inc. for the three and nine months ended September 30, 2020, and 2019, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, along with detailed notes explaining the company's business, liquidity, accounting policies, and significant transactions [Consolidated Balance Sheets](index=3&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) This section provides a snapshot of the company's assets, liabilities, and stockholders' equity at specific reporting dates Consolidated Balance Sheet Highlights | Metric | September 30, 2020 | December 31, 2019 | | :----------------------------------- | :------------------- | :------------------ | | Cash and cash equivalents | $24,311,153 | $6,995,525 | | Total Current Assets | $26,137,058 | $7,764,778 | | Total Assets | $42,816,446 | $24,470,321 | | Total Current Liabilities | $1,474,110 | $700,379 | | Total Liabilities | $1,610,153 | $860,543 | | Total Stockholders' Equity | $41,206,293 | $23,609,778 | [Consolidated Statements of Operations](index=4&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) This section details the company's revenues, expenses, and net loss over specific reporting periods Consolidated Statements of Operations Highlights | Metric | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :----------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | General and administrative | $2,456,266 | $1,916,200 | $4,960,106 | $4,550,306 | | Research and development | $2,362,880 | $1,167,986 | $4,058,710 | $2,415,390 | | Total operating expenses | $4,819,146 | $3,084,186 | $9,018,816 | $5,423,696 | | Net Loss | $(4,716,662) | $(3,066,966) | $(8,894,873) | $(5,360,094) | | Net loss per common share – basic and diluted | $(0.36) | $(0.28) | $(0.77) | $(0.53) | [Consolidated Statement of Changes in Stockholders' Equity](index=5&type=section&id=CONSOLIDATED%20STATEMENT%20OF%20CHANGES%20IN%20STOCKHOLDERS'%20EQUITY) This section outlines the changes in the company's equity accounts, including stock issuances, repurchases, and net loss, over specific periods Changes in Stockholders' Equity (Nine Months Ended Sep 30, 2020) | Metric | Amount | | :----------------------------------- | :------- | | Balance, January 1, 2020 | $23,609,778 | | Issuance of common stock for cash | $24,847,781 | | Acquisition and retirement of common stock | $(1,012,000) | | Stock-based compensation | $2,409,066 | | Net loss | $(8,894,873) | | Balance, September 30, 2020 | $41,206,293 | Changes in Stockholders' Equity (Nine Months Ended Sep 30, 2019) | Metric | Amount | | :----------------------------------- | :------- | | Balance, January 1, 2019 | $16,539,576 | | Issuance of common stock and warrants for cash, net | $7,251,142 | | Stock-based compensation | $2,924,091 | | Waiver of common stock issuable | $(1,542,000) | | Net loss | $(5,360,094) | | Balance, September 30, 2019 | $24,709,316 | [Consolidated Statements of Cash Flows](index=7&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) This section presents the company's cash inflows and outflows from operating, investing, and financing activities for specific periods Consolidated Statements of Cash Flows Highlights (Nine Months Ended Sep 30) | Metric | 2020 | 2019 | | :----------------------------------- | :----------- | :----------- | | Net cash used in operating activities | $(6,550,933) | $(4,951,286) | | Net cash provided by financing activities | $23,895,781 | $12,209,021 | | Net increase in cash | $17,315,628 | $7,196,457 | | Cash and cash equivalents at end of period | $24,311,153 | $7,382,661 | [Notes to the Unaudited Consolidated Financial Statements](index=8&type=section&id=NOTES%20TO%20THE%20UNAUDITED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) This section provides detailed explanations and additional information supporting the unaudited consolidated financial statements [NOTE 1 – ORGANIZATION AND DESCRIPTION OF BUSINESS](index=8&type=section&id=NOTE%201%20%E2%80%93%20ORGANIZATION%20AND%20DESCRIPTION%20OF%20BUSINESS) This note describes INmune Bio, Inc.'s business as a clinical-stage biotechnology company focused on innate immune system therapies - **INmune Bio, Inc.** is a clinical-stage biotechnology company focused on developing product candidates to treat diseases where the innate immune system is dysfunctional[21](index=21&type=chunk) - The company has two product platforms: DN-TNF (targeting soluble TNF for COVID-19, cancer, Alzheimer's, depression, and NASH) and Natural Killer Cell Priming (INKmune for cancer)[21](index=21&type=chunk) [NOTE 2 – LIQUIDITY](index=8&type=section&id=NOTE%202%20%E2%80%93%20LIQUIDITY) This note discusses the company's financial position, accumulated deficit, and ability to meet its operating requirements for the foreseeable future - As of September 30, 2020, the Company had an **accumulated deficit** of **$30,171,054** and has experienced **losses** since its inception, primarily due to **R&D** and general and administrative **expenses**[22](index=22&type=chunk) - The Company believes it has sufficient **cash** to meet its projected **operating requirements** for at least the next 12 months, following a **$23.1 million** net proceeds **public offering** in July 2020 and **$0.8 million** net proceeds from an At-The-Market (ATM) offering program[23](index=23&type=chunk) - The Company also has access to an additional **$18.7 million** from a purchase agreement with Lincoln Park Capital Fund LLC[23](index=23&type=chunk) [NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=9&type=section&id=NOTE%203%20%E2%80%93%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the key accounting principles and estimates used in preparing the financial statements, including the impact of COVID-19 - Financial statements are prepared in accordance with US GAAP and SEC regulations, consolidating **INmune Bio, Inc.** and its subsidiaries[24](index=24&type=chunk) - The COVID-19 pandemic introduces significant risks and uncertainties, potentially delaying clinical trials and impacting the company's **financial condition**, **liquidity**, or **results of operations**, with the full extent being uncertain[26](index=26&type=chunk)[27](index=27&type=chunk)[28](index=28&type=chunk) - **Research and development** tax incentives from Australia and the United Kingdom are recognized as a reduction of **R&D expense** when receipt is reasonably assured[32](index=32&type=chunk)[33](index=33&type=chunk) - There is no difference in basic and diluted **loss per share** due to the company's **net loss** position, as all potential **common shares** are anti-dilutive[35](index=35&type=chunk) [NOTE 4 – RESEARCH AND DEVELOPMENT ACTIVITY](index=11&type=section&id=NOTE%204%20%E2%80%93%20RESEARCH%20AND%20DEVELOPMENT%20ACTIVITY) This note details the company's research and development expenses, tax incentives, and significant licensing agreements for its product candidates R&D Tax Incentive Receivables | Country | September 30, 2020 | December 31, 2019 | | :------ | :----------------- | :---------------- | | UK | $865,228 | $395,850 | | Australia | $600,149 | $172,289 | - The Company holds an exclusive worldwide **license** for Xencor's XPro1595, acquired for **$100,000 cash**, **1,585,000 common shares** (fair value **$12.2M**), and warrants (fair value **$4.2M**), with royalty obligations on **net sales** and sublicensing **revenue**[47](index=47&type=chunk)[48](index=48&type=chunk)[49](index=49&type=chunk)[50](index=50&type=chunk) - The INKmune **License Agreement** grants exclusive worldwide rights with milestone payments (e.g., **$25,000** for Phase I, **$9,000,000** for NDA/EMA awarded) and a **1% royalty** on **net sales**. Milestones for Phase 1, 2, 3, and NDA filing were amended to October 2021, 2023, 2025, and 2026, respectively[51](index=51&type=chunk)[52](index=52&type=chunk) - The University of Pittsburgh **License Agreement** involves annual maintenance fees (e.g., **$5,000** for 2020-2022), a **2.5% royalty** on **net sales**, and milestone payments (e.g., **$50,000** for Phase I, **$1,250,000** for first commercial sale). A **$50,000** Phase I milestone was paid in March 2019[53](index=53&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk)[56](index=56&type=chunk) - A **license agreement** with UCL Business PLC provides exclusive rights to MSC isolation and expansion technology for an initial fee of **$10,000**, annual fees of **$13,000**, and royalties of **3-3.5%** of **net sales** or **12%** of sublicensing **revenue**[58](index=58&type=chunk)[59](index=59&type=chunk) [NOTE 5 – LEASE](index=14&type=section&id=NOTE%205%20%E2%80%93%20LEASE) This note provides information on the company's operating lease for office space, including related assets, liabilities, and expenses - The Company has a 61-month sublease agreement for office space in La Jolla, California, with a related party, CTI Clinical Trial & Consulting Services[60](index=60&type=chunk) Lease Information | Metric | September 30, 2020 | December 31, 2019 | | :----------------------------------- | :------------------- | :------------------ | | Right-of-use asset – related party | $165,388 | $191,543 | | Operating lease, current liability – related party | $20,183 | $8,288 | | Long-term operating lease liability – related party | $136,043 | $160,164 | | Total lease liability | $156,226 | $168,452 | | Weighted-average remaining lease term | 3.8 years | 4.5 years | | Weighted-average discount rate | 10.00% | 10.00% | - **Operating lease expense** for the nine months ended September 30, 2020, was **$39,321**, included in general and administrative **expenses**[60](index=60&type=chunk) [NOTE 6 – RELATED PARTY TRANSACTIONS](index=14&type=section&id=NOTE%206%20%E2%80%93%20RELATED%20PARTY%20TRANSACTIONS) This note discloses transactions and balances with related parties, including payments for medical research and sublease arrangements - The Company owed UCL Consultants Limited **$9,132** as of September 30, 2020, and paid **$334,738** for medical research during the nine months ended September 30, 2020[61](index=61&type=chunk) - The Company owed CTI Clinical Trial & Consulting Services **$0** as of September 30, 2020 (down from **$280,723**), and paid **$126,850** for medical research and **$25,392** for sublease during the nine months ended September 30, 2020[62](index=62&type=chunk) - A capital contribution of **$215,761** was recorded for the forgiveness of certain accounts payable due to CTI during the nine months ended September 30, 2020[62](index=62&type=chunk) [NOTE 7 – STOCKHOLDERS' EQUITY](index=15&type=section&id=NOTE%207%20%E2%80%93%20STOCKHOLDERS'%20EQUITY) This note details changes in stockholders' equity, including stock offerings, repurchases, stock options, and stock-based compensation - The Company completed its initial **public offering** in February 2019, selling **1,020,820 shares** for **$7.3 million** net proceeds[63](index=63&type=chunk) - During the nine months ended September 30, 2020, the Company issued **196,000 shares** to Lincoln Park for **$1.0 million cash**, with **$18.7 million** remaining under the purchase agreement[66](index=66&type=chunk) - In January 2020, the Company purchased and cancelled **220,000 shares** of **common stock** for **$1,012,000 cash**[69](index=69&type=chunk) - From April to September 2020, the Company sold **178,600 shares** through an At-The-Market (ATM) offering program for **$0.8 million** net proceeds[70](index=70&type=chunk) - In July 2020, the Company completed an underwritten **public offering**, selling **2,500,000 shares** at **$10.00 per share** for **$23.1 million** net proceeds[71](index=71&type=chunk) Stock Option Activity (Nine Months Ended Sep 30, 2020) | Metric | Number of Shares | Weighted average Exercise Price | | :----------------------------------- | :--------------- | :------------------------------ | | Outstanding at January 1, 2020 | 3,417,000 | $5.77 | | Options granted | 40,000 | $10.38 | | Outstanding at September 30, 2020 | 3,457,000 | $5.82 | | Exercisable at September 30, 2020 | 1,989,931 | $6.96 | Stock-based Compensation Expense | Period | 2020 | 2019 | | :----------------------------------- | :----------- | :----------- | | Three Months Ended September 30 | $1,045,656 | $974,696 | | Nine Months Ended September 30 | $2,409,066 | $2,924,091 | [NOTE 8 – COLLABORATIVE AGREEMENTS](index=18&type=section&id=NOTE%208%20%E2%80%93%20COLLABORATIVE%20AGREEMENTS) This note describes the company's grant agreements and collaborations for funding its research and development activities - The Company received **$150,000** during the nine months ended September 30, 2020, from a **$1.0 million** Alzheimer's Association **grant** for XPro1595, with the full amount now received[81](index=81&type=chunk) - A **$500,000 grant** from the ALS Association for XPro1595 resulted in **$300,000 cash** proceeds received and recorded as deferred liabilities in 2020, with **$110,878** recognized as a reduction of **R&D expense**[82](index=82&type=chunk) - A **grant** of up to **$2.9 million** from the National Institutes of Health (NIH) was awarded in September 2020 for a Phase 2 study of XPro1595 in treatment-resistant depression, with no proceeds received as of September 30, 2020[83](index=83&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, including forward-looking statements, a detailed business overview, analysis of operating expenses, and a discussion of liquidity and capital resources, highlighting the impact of the COVID-19 pandemic and the company's status as an emerging growth company [Forward-Looking Statements](index=19&type=section&id=Forward-Looking%20Statements) This section cautions readers about forward-looking statements and the inherent risks and uncertainties that could cause actual results to differ materially - The Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties, and actual results may differ materially due to factors such as economic conditions, competition, and technological advances[85](index=85&type=chunk) [Description of Business](index=19&type=section&id=Description%20of%20Business) This section provides an overview of INmune Bio's business, its product platforms, and the impact of the COVID-19 pandemic on its operations [Overview](index=19&type=section&id=Overview) This subsection provides a high-level summary of INmune Bio's clinical-stage immunotherapy focus and product platforms - **INmune Bio** is a clinical-stage immunotherapy company focused on developing drugs that reprogram the innate immune system to treat diseases like cancer, neurodegenerative, metabolic, and infectious diseases[86](index=86&type=chunk) - The DN-TNF platform neutralizes soluble TNF (sTNF) for indications such as cancer (INB03), Alzheimer's/depression (XPro1595), NASH (LIVNate), and COVID-19 (Quellor)[86](index=86&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk)[89](index=89&type=chunk)[90](index=90&type=chunk) - The NK platform (INKmune) aims to prime natural killer cells to eliminate minimal residual disease in cancer patients[86](index=86&type=chunk)[91](index=91&type=chunk) - The Company has incurred **net losses** since inception, with an **accumulated deficit** of **$30.2 million** as of September 30, 2020, and **net losses** of **$8.9 million** and **$5.4 million** for the nine months ended September 30, 2020 and 2019, respectively[92](index=92&type=chunk) - Clinical trials have been and may continue to be affected by the COVID-19 pandemic, potentially causing delays in site initiation, patient enrollment, and compliance with protocols[93](index=93&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) [Research and Development](index=22&type=section&id=Research%20and%20Development) This subsection details the company's R&D expense policies, tax incentives, and expected increases in R&D costs as product candidates advance - **Research and development** (R&D) costs are expensed as incurred, covering preclinical studies, clinical trials, manufacturing, and regulatory activities[99](index=99&type=chunk) - **R&D tax incentives** from Australia and the United Kingdom are recognized as a reduction of **R&D expense**[101](index=101&type=chunk)[102](index=102&type=chunk) - **R&D expenses** are expected to increase significantly as more product candidates advance through clinical development, with costs varying based on trial specifics[103](index=103&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk) [General and Administrative Expenses](index=23&type=section&id=General%20and%20Administrative%20Expenses) This subsection outlines the primary components of the company's general and administrative expenses, including payroll and professional fees - **General and administrative expenses** primarily include payroll, **stock-based compensation**, professional fees (legal, consulting, accounting, tax), and overhead costs[106](index=106&type=chunk) [Other income](index=23&type=section&id=Other%20income) This subsection describes the sources of the company's other income, such as interest income and foreign exchange gains/losses - **Other income** primarily consists of interest income, foreign exchange gains/losses, and other non-operating income/expense[107](index=107&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance by comparing key operating expenses and net loss for the current and prior periods [Comparison of the Three Months Ended September 30, 2020 and 2019](index=24&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20September%2030,%202020%20and%202019) This subsection compares the company's financial results, including operating expenses and net loss, for the three months ended September 30, 2020 and 2019 Results of Operations (Three Months Ended Sep 30) | Metric | 2020 | 2019 | Change | | :----------------------------------- | :----------- | :----------- | :----------- | | General and administrative | $2,456,266 | $1,916,200 | $540,066 | | Research and development | $2,362,880 | $1,167,986 | $1,194,894 | | Total operating expenses | $4,819,146 | $3,084,186 | $1,734,960 | | Net loss | $(4,716,662) | $(3,066,966) | $(1,649,696) | | Other income | $102,484 | $17,220 | $85,264 | - **General and administrative expenses** increased by **$0.6 million**, primarily due to higher professional fees (**$0.6M**) and **stock-based compensation** (**$0.4M**), partially offset by lower investor relations expense (**$0.5M**)[110](index=110&type=chunk) - **Research and development expenses** increased by **$1.2 million**, driven by advancement of the drug platform and manufacturing costs for the DN-TNF product[111](index=111&type=chunk) - **Other income** increased by **$0.1 million** due to a refund from a third-party vendor[112](index=112&type=chunk) [Comparison of the Nine Months Ended September 30, 2020 and 2019](index=25&type=section&id=Comparison%20of%20the%20Nine%20Months%20Ended%20September%2030,%202020%20and%202019) This subsection compares the company's financial results, including operating expenses and net loss, for the nine months ended September 30, 2020 and 2019 Results of Operations (Nine Months Ended Sep 30) | Metric | 2020 | 2019 | Change | | :----------------------------------- | :----------- | :----------- | :----------- | | General and administrative | $4,960,106 | $4,550,306 | $409,800 | | Research and development | $4,058,710 | $2,415,390 | $1,643,320 | | Waiver of common stock issuable | $0 | $(1,542,000) | $1,542,000 | | Total operating expenses | $9,018,816 | $5,423,696 | $3,595,120 | | Net loss | $(8,894,873) | $(5,360,094) | $(3,534,779) | | Other income | $123,943 | $63,602 | $60,341 | - **General and administrative expenses** increased by **$0.4 million**, mainly due to higher professional fees (**$0.6M**), **stock-based compensation** (**$0.3M**), and salary/benefits (**$0.2M**), offset by lower investor relations expense (**$1.0M**)[115](index=115&type=chunk) - **Research and development expenses** increased by **$1.6 million**, primarily due to advancement of the drug platform and manufacturing costs for the DN-TNF product[116](index=116&type=chunk) - A **$1.5 million** expense reversal from a waiver of **common stock** issuable occurred in 2019, with no similar transaction in 2020, contributing to the comparative increase in **total operating expenses**[117](index=117&type=chunk) - **Other income** increased by **$0.1 million** due to a refund from a third-party vendor[118](index=118&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, funding sources, and ability to meet its short-term and long-term financial obligations - The Company incurred a **net loss of $8.9 million** and used **$6.6 million** in **cash** from **operating activities** for the nine months ended September 30, 2020[120](index=120&type=chunk) - As of September 30, 2020, **cash and cash equivalents** totaled **$24.3 million**, and the Company believes this is sufficient to fund **operations** for at least the next 12 months[120](index=120&type=chunk)[124](index=124&type=chunk) - Primary uses of capital include third-party clinical/preclinical **R&D** services, compensation, legal, patent, regulatory **expenses**, and general overhead[121](index=121&type=chunk) - Significant capital raises in 2020 include **$23.1 million** net proceeds from an underwritten **public offering** and **$0.8 million** net proceeds from an ATM program[129](index=129&type=chunk)[130](index=130&type=chunk) - The Company also received **$1.0 million** in gross proceeds from Lincoln Park Capital and purchased **$1.0 million** of **common stock** during the nine months ended September 30, 2020[128](index=128&type=chunk)[139](index=139&type=chunk) - **Grants** received in 2020 include **$150,000** from the Alzheimer's Association and **$300,000** from the ALS Association, with a **$2.9 million** NIH **grant** awarded but not yet funded[131](index=131&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk) [Cash Flows](index=28&type=section&id=Cash%20Flows) This subsection details the company's cash flows from operating, investing, and financing activities, highlighting significant changes and funding sources Cash Flow Summary (Nine Months Ended Sep 30) | Metric | 2020 | 2019 | | :----------------------------------- | :----------- | :----------- | | Net cash used in operating activities | $(6,550,933) | $(4,951,286) | | Net cash provided by financing activities | $23,895,781 | $12,209,021 | | Net increase in cash | $17,315,628 | $7,196,457 | | Cash and cash equivalents, end of period | $24,311,153 | $7,382,661 | - **Operating activities** used **$6.6 million cash** in 2020, primarily due to a **net loss of $8.9 million** and a net **cash** outflow of **$0.1 million** from changes in **operating assets** and **liabilities**, partially offset by **$2.4 million** in non-cash **stock-based compensation**[136](index=136&type=chunk) - **Financing activities** provided **$23.9 million cash** in 2020, mainly from **$23.1 million** net proceeds from a **public offering**, **$1.0 million** from Lincoln Park sales, and **$0.9 million** net from the ATM program, partially offset by a **$1.0 million common stock** repurchase[138](index=138&type=chunk)[139](index=139&type=chunk) [Critical Accounting Policies](index=29&type=section&id=Critical%20Accounting%20Policies) This section confirms the consistency of the company's critical accounting policies and estimates with its prior annual report - The Company's critical accounting policies and estimates are consistent with those in its Annual Report on Form 10-K for the fiscal year ended December 31, 2019, with no material changes during the nine months ended September 30, 2020[144](index=144&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) As a smaller reporting company, INmune Bio is exempt from providing quantitative and qualitative disclosures about market risk in this report - The Company is not required to provide market risk disclosures as it qualifies as a 'smaller reporting company' under Rule 229.10(f)(1)[145](index=145&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were not effective as of September 30, 2020, primarily due to limited segregation of duties. The company has engaged a consulting firm to address this, and no material changes in internal control over financial reporting occurred during the quarter - Management concluded that disclosure controls and procedures were not effective as of September 30, 2020, due to the small size of the Company and limited segregation of duties[146](index=146&type=chunk) - The Company has engaged a consulting firm with accounting expertise to assist in correcting the limited segregation of duties[146](index=146&type=chunk) - There were no material changes in internal control over financial reporting during the three months ended September 30, 2020[147](index=147&type=chunk) PART II – OTHER INFORMATION This section covers legal proceedings, risk factors, recent securities sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings that are expected to have a material adverse effect on its business or financial condition - The Company is not currently a party to any pending legal proceedings that are believed to have a material adverse effect on its business or financial conditions[150](index=150&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, INmune Bio is not required to provide a discussion of risk factors in this report - Risk factors disclosure is not required for smaller reporting companies[151](index=151&type=chunk) [Item 2. Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities](index=30&type=section&id=Item%202.%20Recent%20Sales%20of%20Unregistered%20Securities%3B%20Use%20of%20Proceeds%20from%20Registered%20Securities) There were no recent sales of unregistered securities or use of proceeds from registered securities to report during this period - No recent sales of unregistered securities or use of proceeds from registered securities to report[152](index=152&type=chunk) [Item 3. Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - This item is not applicable[153](index=153&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[154](index=154&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) There is no other information to report under this item - This item is not applicable[155](index=155&type=chunk) [Item 6. Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including an amendment to an exclusive license agreement, CEO and CFO certifications, and XBRL taxonomy documents - Exhibits include an Amendment to Exclusive **License Agreement**, Rule 13a-14(a)/15d-14(a) Certifications of CEO and CFO, Section 1350 Certifications of CEO and CFO, and various XBRL documents[156](index=156&type=chunk) SIGNATURES This section contains the official signatures of the company's executive officers, certifying the report's submission [Signatures](index=31&type=section&id=SIGNATURES_DETAILS) The report was officially signed on November 5, 2020, by Raymond J. Tesi, Chief Executive Officer, and David J. Moss, Chief Financial Officer, Treasurer, and Secretary, confirming its submission - The report was signed on November 5, 2020, by Raymond J. Tesi (Chief Executive Officer) and David J. Moss (Chief Financial Officer, Treasurer, Secretary)[160](index=160&type=chunk)

IViunine Bio HARNESSING THE POWER OF THE INNATE IMMUNE SYSTEM Modulating an Innate Immune Response Against Diseases INMB CORPORATE PRESENTATION Aug 2020 FORWARD LOOKING STATEMENTS This presentation contains "forward-looking statements" Forward-looking statements reflect our current view about future events. When used in this presentation, the words "anticipate," "believe," "estimate," "expect," "future," "intend," "plan," or the negative of these terms and similar expressions, as they relate to us or our ma ...

INmune Bio Inc. (NASDAQ:INMB) Q2 2020 Earnings Conference Call August 5, 2020 4:30 PM ET Company Participants RJ Tesi - Co-Founder & Chief Executive Officer David Moss - Co-Founder & Chief Financial Officer Conference Call Participants Jonathan Aschoff - ROTH Capital Partners Naureen Quibria - Maxim Group Arthur He - H.C. Wainwright Operator Greetings and welcome to the INmune Bio Second Quarter 2020 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. A transcript will f ...

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 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 525 La Jolla, CA 92037 (Address of principal executive of ice) (Zip code) FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2020 OR ☐ TRANSITION REPO ...

Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for Q1 2020 was $2.1 million, compared to $1.9 million for Q1 2019 [30] - Research and Development expenses totaled approximately $0.8 million for Q1 2020, compared to approximately $0.6 million for Q1 2019 [30] - General and administrative expenses were approximately $1.3 million in both Q1 2020 and Q1 2019 [31] - As of March 31, 2020, the company had cash and cash equivalents of approximately $5.9 million with no debt [31] Business Line Data and Key Metrics Changes - The DN-TNF Platform includes four therapeutic programs: INB03 for cancer, LIVNate for NASH, Quellor for COVID-19 complications, and XPro1595 for Alzheimer's disease [7][8] - The XPro1595 program is expected to have data for review in October 2020 [13] - The INB03 program targets women with metastatic HER2+ breast cancer, with a planned Phase 2 trial informed by recent research [15][16] Market Data and Key Metrics Changes - The NK Priming Platform, INKmune, is being studied in solid tumors and hematologic malignancies, with delays due to the COVID-19 pandemic [24][28] - The company is focusing on enrolling patients in high-risk MDS and ovarian cancer trials, with expectations for patient enrollment in 2021 [28][35] Company Strategy and Development Direction - The company is prioritizing programs that can bring value to investors and make a difference at the bedside [82] - The strategic assessment led to the initiation of the Quellor program targeting cytokine storms related to COVID-19 [8] - The company is exploring non-dilutive funding options to support clinical trials [12][33] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism about meeting clinical trial goals despite challenges posed by the COVID-19 pandemic [28][70] - The FDA has been responsive and supportive in the context of COVID-19, facilitating trial designs [70] - The company is monitoring the evolving situation regarding COVID-19 and its impact on patient populations [57][70] Other Important Information - The company has signed an agreement with KBI Biopharma for drug manufacturing to support expanding clinical programs [23][55] - The company is preparing for a potential pediatric plan related to COVID-19 complications, considering the role of TNF inhibitors [64] Q&A Session Summary Question: Concerns about Lapatinib's commercial viability - Management acknowledged the challenges in restoring Lapatinib sensitivity but emphasized the importance of addressing trastuzumab resistance in treatment strategies [38][39] Question: R&D expense trends - Management indicated ongoing evaluations of costs related to the COVID trial, with potential expenses ranging from $3 million to $5 million [42][43] Question: Drug product availability for COVID study - Management confirmed sufficient drug supply for the COVID trial and outlined a two-step Phase 2 trial design with a total of 360 patients [47][48] Question: Timing of COVID-19 trial - Management noted that the trial's timing depends on FDA approval and the severity of COVID-19 in the U.S. [70][71] Question: Plans for Kawasaki-like disease in pediatrics - Management is closely monitoring developments related to Kawasaki-like disease and sees potential for their drug in this context [63][64] Question: Alzheimer's disease program details - Management provided insights into the Phase I trial design, focusing on biomarkers of inflammation and cognitive outcomes [75][78]