8-K
Inmune Bio, Inc. (INMB)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of theSecurities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 5, 2020
| INMUNE BIO INC. |
|---|
| (Exact name of registrant as specified in charter) |
| Nevada | 001-38793 | 47-5205835 |
|---|---|---|
| (State or other jurisdiction | (Commission | (IRS Employer |
| of incorporation) | File Number) | Identification No.) |
1200 Prospect Street, Suite 525, LaJolla, CA 92037
(Address of Principal Executive Offices) (Zip Code)
(858) 964 3720
(Registrant’s Telephone Number, Including Area Code)
Not Applicable
(Former Name or Former Address, If Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mart if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.001 per share | INMB | The NASDAQ Stock Market LLC |
Item 2.02 Results of Operations and Financial Condition.
On August 5, 2020, INmune Bio Inc. (the “Company”) issued a press release announcing the Company’s financial and operating results for the second quarter ended June 30, 2020 and provided a business update. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in this Current Report, including the exhibits hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document filed by the Company with the Securities and Exchange Commission, whether made before or after the date of this report, regardless of any general incorporation language in such filing (or any reference to this Current Report on Form 8-K generally), except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial statements and Exhibits
(d) Exhibits.
| ExhibitNumber | Description |
|---|---|
| 99.1 | Press Release, dated August 5, 2020 |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: August 6, 2020 | INMUNE BIO INC. | |
|---|---|---|
| By: | /s/ David Moss | |
| David Moss | ||
| Chief Financial Officer |
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Exhibit 99.1
INmune Bio, Inc. Announces Second Quarter 2020 Results and Provides Business Update
The company will host an earnings call: Today, August 5 at4:30 PM ET
LA JOLLA, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), an immunology company developing treatments that harness the patient’s innate immune system to fight disease today reported its financial results for the second quarter ended June 30, 2020 and is providing a business update. INmune Bio will hold a conference call today at 4:30 PM Eastern Time. To participate in the call, please dial 415-226-5355 five minutes before the scheduled time.
“In the second quarter, and year to date, INmune Bio continued to progress forward with both of our clinical platforms,” stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “We announced interim Phase Ib data demonstrating that our Alzheimer’s Disease candidate, XPro1595, can reduce neuroinflammation. Our progress with XPro1595 supports our overall strategy to create platforms of therapeutics, based on reducing inflammation by targeting the innate immune system to fight disease. We are planning a number of programs employing this approach in NASH, MUC4 expressing HER2+ cancer, ALS and complications of cytokine storm caused by COVID-19. With the Natural Killer Priming platform, we anticipate INKmune™ Phase I in high-risk MDS to start the second half of this year.”
Q2 2020 and Recent Corporate Highlights
DN-TNF Platform Highlights:
| ● | Announced<br> interim Phase Ib data demonstrating that XPro1595 decreases neuroinflammation in patients<br> with Alzheimer’s Disease - XPro1595 reduced neuroinflammation by 40.6% in a white matter<br> tract important for learning and memory. |
|---|---|
| ● | Announced<br> combination therapy of Lapatinib with INB03 may be used to overcome resistance to trastuzumab<br> in women with MUC4+/HER2+ breast cancer. This work was presented at the AACR 2020<br> by Dr. Roxana Schillaci and may form the basis for a Phase II program in patients with<br> MUC4 expressing HER2+ cancer. |
| --- | --- |
| ● | Initiated<br> a clinical program to test targeting soluble TNF (Quellor™), one of the key components<br> of the cytokine storm, using our TNF Inhibitor (DN-TNF) Platform to prevent complications<br> of COVID-19 infection. |
| --- | --- |
| ● | Frontiers<br> in Oncology published an invited entitled Tumor Necrosis Factor α Blockade:<br> an Opportunity to Tackle Breast Cancer **** by Prof. Roxana Schillaci, a leader<br> in the field of TNF in cancer. |
| --- | --- |
NKPriming Platform Highlights:
| ● | Received<br> regulatory clearance from UK MHRA to initiate a Phase I Trial of INKmune in patients<br> with high-risk MDS - study will be the first-in man trial for INKmune – a novel<br> therapy to prime the patient’s own NK cells to attack their cancer. |
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| ● | Announced<br> allowance of U.S. Patent covering method for treating cancer by in-vivo priming of natural<br> killer cells. |
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| ● | Received<br> notice of allowance in counterpart patent in Australia covering method for treating cancer<br> by in-vivo priming of natural killer cells. |
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| ● | Announced<br> publication of a review article: Killers at the crossroads: The use of innate immune cells in adoptive cellular therapy of cancer in the journal Stem Cells<br> Translational Medicine by Prof. Mark Lowdell, Co-Founder and CSO of INmune Bio, Inc. <br> The article reviews the potential of harnessing cells of the innate immune system to<br> treat cancer. |
| --- | --- |
FinancialHighlights:
| ● | Closed<br>a $25 million gross proceeds public offering of common stock, including full exercise of Underwriters’ Over-Allotment Option<br>resulting in net proceeds of approximately $23.1 million after deducting underwriting discounts and commissions and other offering<br>expenses payable by the Company. |
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UpcomingMilestones:
| ● | Report<br> additional data on Phase 1b XPro1595 in Alzheimer’s Disease in 2H 2020. |
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| ● | Enroll<br> first patient in Phase II Quellor™ program, targeting COVID-19 patients with immune<br> mediated complications from COVID-19. |
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| ● | Enroll<br> first patient in Phase I INKmune™ in High Risk MDS cancer, expected 2H20. |
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| ● | Enroll<br> first patient in Phase I INKmune™ in Ovarian cancer, expected mid-2021. |
| --- | --- |
FinancialResults for the Second Quarter Ended June 30, 2020:
Net loss attributable to common stockholders for the second quarter ended June 30, 2020 was $2.1 million, compared to $0.4 million for the quarter ended June 30, 2019.
Research and development expense totaled approximately $0.9 million for the second quarter ended June 30, 2020, compared to approximately $0.6 million during the second quarter ended June 30, 2019.
General and administrative expense was approximately $1.2 million for the quarter ended June 30, 2020, compared to approximately $1.3 million during the second quarter ended June 30, 2019.
As of June 30, 2020, the Company had cash and cash equivalents of approximately $4.8 million with no debt. Subsequent to the quarter end, INmune Bio closed a $25 million gross proceeds public offering of common stock resulting in net proceeds of approximately $23.1 million after deducting underwriting discounts and commissions and other offering expenses payable by the Company.
As of August 5, 2020, the Company had approximately 13.4 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: August 5, 2020
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-415-226-5355
About INmune Bio, Inc.
INmune Bio, Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is currently being developed for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer’s (XPro595), and NASH (LIVNate™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation. To learn more, please visit www.inmunebio.com.
Information about Forward-Looking Statements
Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, Quellor™, XPro1595, LIVNate™, and INKmune™ are still in clinical trials and have not been approved and there cannot be any assurance that they will be approved or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
**INmune Bio Contact:**David Moss, CFO (858) 964-3720
Investor Contact:
James Carbonara (646) 755-7412
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The following table summarizes our results of operations for the periods indicated:
INMUNE BIO, INC.
CONSOLIDATED BALANCE SHEETS(Unaudited)
| December 31,<br> 2019 | |||||
|---|---|---|---|---|---|
| ASSETS | |||||
| CURRENT ASSETS | |||||
| Cash and cash equivalents | 4,816,561 | $ | 6,995,525 | ||
| Research and development tax credit receivable | 1,044,843 | 568,139 | |||
| Other tax receivable | 155,000 | 77,225 | |||
| Prepaid expenses | 342,492 | 97,623 | |||
| Prepaid expenses – related party | - | 26,266 | |||
| TOTAL CURRENT ASSETS | 6,358,896 | 7,764,778 | |||
| Operating lease – right of use asset – related party | 174,649 | 191,543 | |||
| Acquired in-process research and development intangible assets | 16,514,000 | 16,514,000 | |||
| TOTAL ASSETS | 23,047,545 | $ | 24,470,321 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| CURRENT LIABILITIES | |||||
| Accounts payable and accrued liabilities | 624,893 | $ | 401,989 | ||
| Accounts payable and accrued liabilities – related parties | 223,562 | 290,102 | |||
| Deferred liabilities | 361,842 | - | |||
| Operating lease, current liability – related party | 6,950 | 8,288 | |||
| TOTAL CURRENT LIABILITIES | 1,217,247 | 700,379 | |||
| Long-term operating lease liability – related party | 145,430 | 160,164 | |||
| TOTAL LIABILITIES | 1,362,677 | 860,543 | |||
| COMMITMENTS AND CONTINGENCIES | |||||
| STOCKHOLDERS’ EQUITY | |||||
| Preferred stock, 0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding | - | - | |||
| Common stock, 0.001 par value, 200,000,000 shares authorized, 10,897,630 and 10,770,948 shares issued and outstanding, respectively | 10,898 | 10,771 | |||
| Additional paid-in capital | 47,068,236 | 44,833,703 | |||
| Common stock issuable | 50,000 | 50,000 | |||
| Accumulated other comprehensive loss | 10,126 | (8,515 | ) | ||
| Accumulated deficit | (25,454,392 | ) | (21,276,181 | ) | |
| TOTAL STOCKHOLDERS’ EQUITY | 21,684,868 | 23,609,778 | |||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | 23,047,545 | $ | 24,470,321 |
All values are in US Dollars.
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INMUNE BIO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited)
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | |||||
| REVENUE | - | - | - | - | ||||
| OPERATING EXPENSES | ||||||||
| General and administrative | ||||||||
| Research and development | ||||||||
| Waiver of common stock issuable | ) | ) | ||||||
| Total operating expenses | ||||||||
| LOSS FROM OPERATIONS | ) | ) | ) | ) | ||||
| OTHER (EXPENSE) INCOME | ) | |||||||
| NET LOSS | ) | ) | ) | ) | ||||
| Net loss per common share – basic and diluted | ) | ) | ) | ) | ||||
| Weighted average common shares outstanding - basic and diluted | ||||||||
| COMPREHENSIVE LOSS | ||||||||
| Net loss | ) | ) | ) | ) | ||||
| Other comprehensive gain (loss) – gain (loss) on foreign currency translation | ) | ) | ||||||
| Total comprehensive loss | ) | ) | ) | ) |
All values are in US Dollars.
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INMUNE BIO, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudited)
| For the Six Months Ended <br><br>June 30, | ||||||
|---|---|---|---|---|---|---|
| 2020 | 2019 | |||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||
| Net loss | $ | (4,178,211 | ) | $ | (2,293,128 | ) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
| Stock-based compensation | 1,363,410 | 1,949,395 | ||||
| Waiver of common stock issuable | - | (1,542,000 | ) | |||
| Changes in operating assets and liabilities: | ||||||
| Research and development tax credit receivable | (476,704 | ) | (251,472 | ) | ||
| Other tax receivable | (77,775 | ) | (67,315 | ) | ||
| Joint development cost receivable | - | (31,340 | ) | |||
| Prepaid expenses | (244,869 | ) | (184,472 | ) | ||
| Prepaid expenses – related party | 26,266 | (244,882 | ) | |||
| Accounts payable and accrued liabilities | 222,904 | (115,004 | ) | |||
| Accounts payable and accrued liabilities – related parties | 149,221 | (200,654 | ) | |||
| Deferred liabilities | 361,842 | - | ||||
| Operating lease liability – related party | 822 | (24,653 | ) | |||
| Net cash used in operating activities | (2,853,094 | ) | (3,005,525 | ) | ||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||
| Net proceeds from sale of common stock | 1,667,489 | 12,209,021 | ||||
| Purchase of common stock | (1,012,000 | ) | - | |||
| Net cash provided by financing activities | 655,489 | 12,209,021 | ||||
| Impact on cash from foreign currency translation | 18,641 | (25,736 | ) | |||
| NET (DECREASE) INCREASE IN CASH | (2,178,964 | ) | 9,177,760 | |||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 6,995,525 | 186,204 | ||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 4,816,561 | $ | 9,363,964 | ||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||||
| Cash paid for income taxes | $ | - | $ | - | ||
| Cash paid for interest expense | $ | - | $ | - | ||
| NONCASH INVESTING AND FINANCING ACTIVITIES: | ||||||
| Capital contribution | $ | 215,761 | $ | - | ||
| Issuance of warrants to placement agents | $ | - | $ | 247,452 | ||
| Issuance of common stock issuable | $ | - | $ | 3,084,000 |
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