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): November 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<br>communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br>material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement<br>communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement<br>communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
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 andFinancial Condition.
On November 5, 2020, INmune Bio Inc. (the “Company”) issued a press release announcing the Company’s financial and operating results for the third quarter ended September 30, 2020 and providing 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.
| Exhibit Number | Description |
|---|---|
| 99.1 | Press Release, date November 5, 2020 |
| 1 |
| --- |
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: November 5, 2020 | INMUNE BIO INC. | |
|---|---|---|
| By: | /s/ David Moss | |
| David Moss | ||
| Chief Financial Officer |
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Exhibit 99.1
INmuneBio, Inc. Announces Third Quarter Results and Provides Business Update
Company to host conference call today, November 5, at 4:30pm ET
LA JOLLA, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- 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, today reported its financial results for the third quarter ended September 30, 2020 and provided a business update.
“Since our second quarter update, we have made progress with our neuroinflammation franchise. First, we reported positive Phase 1b data in July demonstrating that XPro1595 decreased neuroinflammation by more than 40% in the arcuate fasciculus, a white matter pathway important for learning and memory in Alzheimer’s patients. More recently, we announced receipt of an NIH Small Business Innovation Research Grant of up to $2.9 million to support a Phase 2 study of XPro1595 in treatment resistant depression patients, or TRD,” stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “We believe that TRD represents an important expansion of our neuroinflammation program, and we are working hard to initiate Phase 2 trials in Alzheimer’s and TRD next year.”
“In addition, we continue to advance our other programs across both our DN-TNF and INKmune platforms. In DN-TNF, we have opened a Phase II clinical trial using Quellor to treat patients hospitalized from complications of COVID-19. In 2021, assuming the clinical landscape has not changed, and the pandemic is controlled, we will initiate planning for the Phase II trials of LIVNate in NASH and INB03 in cancer. We are also poised to advance our INKmune programs in ovarian cancer and high-risk MDS as well. Overall, we are pleased with our progress in the third quarter and year-to-date,” concluded Dr. Tesi.
Q3 2020 and RecentCorporate Highlights
DN-TNF PlatformHighlights:
| ● | Announced interim<br> Phase Ib data demonstrating that over a 12-week period, XPro1595 decreased neuroinflammation<br> by 40.6% in the arcuate fasciculus, a white matter pathway important for learning and<br> memory in patients with Alzheimer’s disease. The 13 July KOL webinar discussing<br> the data can be found by https://inmunebio.com/index.php/en/science/xpro1595/videos. |
|---|---|
| ● | Awarded a National<br> Institutes of Health (NIH) Small Business Innovation Research Grant of up to $2.9 million<br> to support a phase 2 study of XPro1595 in patients with treatment resistant depression<br> (TRD). The study, entitled, “Effects of the Next Generation TNF Inhibitor (XPro1595)<br> on Inflammation-related Deficits in Reward Circuitry and Motivation in Depression,”<br> will be conducted at two sites in the U.S. – Emory University School of Medicine<br> in Atlanta and University of Alabama in Birmingham. |
| --- | --- |
| ● | Hosted a Key<br> Opinion Leader (KOL) webinar on the topic of treatment resistant depression. The webinar<br> discussed the role of neuroinflammation in TRD and featured presentations by two highly-regarded<br> thought leaders in the field: Charles Raison, M.D., professor in the department of psychiatry<br> at the University of Wisconsin at Madison, and John E. Schneider, Ph.D., chief executive<br> officer and principal of Avalon Health Economics. A replay of the webinar can be found<br> by https://inmunebio.com/index.php/en/science/xpro1595-trd/videos. |
| --- | --- |
| ● | Announced FDA<br> acceptance of an Investigational New Drug (IND) application to initiate a Phase 2 clinical<br> trial evaluating Quellor™, a selective soluble tumor necrosis factor (sTNF) inhibitor,<br> for the treatment of immune mediated complications in COVID-19 patients. |
| --- | --- |
| ● | Announced that<br> the European Patent Office has granted a patent covering XPro1595 and its peripheral<br> administration for treating Alzheimer’s disease and other diseases of the CNS.<br> The patent expires in 2033. |
| --- | --- |
NK Priming PlatformHighlights:
| ● | Announced that<br> the US Patent and Trademark Office has issued a patent covering a method for treating<br> cancer using INKmune™, the company’s natural killer (NK) cell priming technology.<br> The patent expires in 2036. |
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Financial Highlights:
| ● | Closed a $25<br> million public offering of common stock, including full exercise of the underwriters’<br> over-allotment option, resulting in net proceeds of approximately $23.1 million. |
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Upcoming Milestones:
2020:
| ● | Enroll first<br> patient in Phase II Quellor™ program, targeting COVID-19 patients with immune mediated<br> complications from COVID-19. |
|---|
2021:
| ● | Report additional<br> data on Phase 1b XPro1595 in Alzheimer’s Disease in January 2021. The company will<br> host a KOL call in tandem with the announcement. |
|---|---|
| ● | XPro1595 Phase<br> 2 program for treatment resistant depression. |
| --- | --- |
| ● | XPro1595 Phase<br> 2 program for Alzheimer's disease in patients with neuro-inflammation. |
| --- | --- |
The company plans additional clinical trials after the COVID-19 pandemic has been controlled. The exact timing of these trials cannot be predicted at this time:
| ● | INKmune Phase<br> 1 program for ovarian cancer. |
|---|---|
| ● | INKmune Phase<br> 1 program for high-risk MDS. |
| --- | --- |
| ● | LIVNate Phase<br> 2 program for NASH. |
| --- | --- |
| ● | INB03 Phase<br> 2 program for MUC4 expressing cancer. |
| --- | --- |
Financial Resultsfor the Third Quarter Ended September 30, 2020:
Net loss attributable to common stockholders for the third quarter ended September 30, 2020 was approximately $4.7 million, compared to approximately $3.1 million for the quarter ended September 30, 2019.
Research and development expense totaled approximately $2.4 million for the third quarter ended September 30, 2020, compared to approximately $1.2 million during the third quarter ended September 30, 2019.
General and administrative expense was approximately $2.5 million for the quarter ended September 30, 2020, compared to approximately $1.9 million during the third quarter ended September 30, 2019.
As of September 30, 2020, the Company had cash and cash equivalents of approximately $24.3 million and no debt. September 30 cash and cash equivalents reflects a public offering of common stock which the company completed in July which raised net proceeds of approximately $23.1 million.
As of November 5, 2020, the Company had approximately 13.4 million common shares outstanding.
Earnings CallInformation
To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.
Date: Thursday, November 5, 2020
Time: 4:30 PM Eastern Time
Participant Dial-in: 800-909-4145
Participant Dial-in (international): 415-226-5358
A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through November 12 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 21970461.
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About XPro1595
XPro1595 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. XPro1595 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 (https://www.inmunebio.com/index.php/en/science/xpro1595/overview).
About INmuneBio, 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 that are both in clinical trials. 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 in clinical trial to determine if it can treat for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer’s and treatment resistant depression (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.
Forward LookingStatements
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 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™, XPro1595, LIVNate, Quellor™ and INKmune are still in clinical trials or preparing to start 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. Our two platforms are beginning clinical trials and there cannot be any assurance of the success of these trials. 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:
Chuck Padala
LifeSci Advisors
(646) 627-8390
Media Contact:
Meredith Sosulski, Ph.D.
LifeSci Communications
(929) 469-3851
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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, 2019 | **** | |||
|---|---|---|---|---|---|
| ASSETS | |||||
| CURRENT ASSETS | |||||
| Cash and cash equivalents | 24,311,153 | $ | 6,995,525 | ||
| Research and development tax incentive receivable | 1,465,377 | 568,139 | |||
| Other tax receivable | 143,657 | 77,225 | |||
| Prepaid expenses | 216,871 | 97,623 | |||
| Prepaid expenses –<br> related party | - | 26,266 | |||
| TOTAL CURRENT ASSETS | 26,137,058 | 7,764,778 | |||
| Operating lease – right of use asset –<br> related party | 165,388 | 191,543 | |||
| Acquired in-process research<br> and development intangible assets | 16,514,000 | 16,514,000 | |||
| TOTAL ASSETS | 42,816,446 | $ | 24,470,321 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| CURRENT LIABILITIES | |||||
| Accounts payable and accrued liabilities | 1,191,086 | $ | 401,989 | ||
| Accounts payable and accrued liabilities –<br> related parties | 9,132 | 290,102 | |||
| Deferred liabilities | 253,709 | - | |||
| Operating lease, current<br> liability – related party | 20,183 | 8,288 | |||
| TOTAL CURRENT LIABILITIES | 1,474,110 | 700,379 | |||
| Long-term operating lease<br> liability – related party | 136,043 | 160,164 | |||
| TOTAL LIABILITIES | 1,610,153 | 860,543 | |||
| COMMITMENTS AND CONTINGENCIES | |||||
| STOCKHOLDERS’ EQUITY | |||||
| Preferred stock, 0.001 par value, 10,000,000 shares<br> authorized, 0 shares issued and outstanding | - | - | |||
| Common stock, 0.001 par value, 200,000,000 shares<br> authorized, 13,447,948 and 10,770,948 shares issued and outstanding, respectively | 13,448 | 10,771 | |||
| Additional paid-in capital | 71,351,634 | 44,833,703 | |||
| Common stock issuable | 50,000 | 50,000 | |||
| Accumulated other comprehensive loss | (37,735 | ) | (8,515 | ) | |
| Accumulated deficit | (30,171,054 | ) | (21,276,181 | ) | |
| TOTAL STOCKHOLDERS’<br> EQUITY | 41,206,293 | 23,609,778 | |||
| TOTAL LIABILITIES AND STOCKHOLDERS’<br> EQUITY | 42,816,446 | $ | 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 September 30, | **** | For the Nine Months Ended September 30, | **** | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| **** | 2020 | **** | 2019 | **** | 2020 | **** | 2019 | **** | ||||
| REVENUE | $ | - | $ | - | $ | - | $ | - | ||||
| OPERATING EXPENSES | ||||||||||||
| 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 | ||||||||
| Waiver of common stock issuable | - | - | - | (1,542,000 | ) | |||||||
| Total operating expenses | 4,819,146 | 3,084,186 | 9,018,816 | 5,423,696 | ||||||||
| LOSS FROM OPERATIONS | (4,819,146 | ) | (3,084,186 | ) | (9,018,816 | ) | (5,423,696 | ) | ||||
| OTHER INCOME | 102,484 | 17,220 | 123,943 | 63,602 | ||||||||
| 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 | ) |
| Weighted average common shares outstanding - basic and diluted | 12,926,539 | 10,762,473 | 11,496,753 | 10,105,675 | ||||||||
| COMPREHENSIVE LOSS | ||||||||||||
| Net loss | $ | (4,716,662 | ) | $ | (3,066,966 | ) | $ | (8,894,873 | ) | $ | (5,360,094 | ) |
| Other comprehensive loss on foreign currency translation | (47,861 | ) | (35,542 | ) | (29,220 | ) | (61,278 | ) | ||||
| Total comprehensive loss | $ | (4,764,523 | ) | $ | (3,102,508 | ) | $ | (8,924,093 | ) | $ | (5,421,372 | ) |
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INMUNE BIO, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudited)
| **** | For the Nine Months Ended September 30, | **** | ||||
|---|---|---|---|---|---|---|
| **** | 2020 | **** | 2019 | **** | ||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||
| Net loss | $ | (8,894,873 | ) | $ | (5,360,094 | ) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
| Stock-based compensation | 2,409,066 | 2,924,091 | ||||
| Waiver of common stock issuable | - | (1,542,000 | ) | |||
| Changes in operating assets and liabilities: | ||||||
| Research and development tax incentive receivable | (897,238 | ) | (361,769 | ) | ||
| Other tax receivable | (66,432 | ) | (68,460 | ) | ||
| Joint development cost receivable | - | 17,989 | ||||
| Prepaid expenses | (119,248 | ) | (106,478 | ) | ||
| Prepaid expenses – related party | 26,266 | (118,602 | ) | |||
| Accounts payable and accrued liabilities | 789,097 | (215,983 | ) | |||
| Accounts payable and accrued liabilities – related parties | (65,209 | ) | (108,434 | ) | ||
| Deferred liabilities | 253,709 | - | ||||
| Operating lease liability – related party | 13,929 | (11,546 | ) | |||
| Net cash used in operating activities | (6,550,933 | ) | (4,951,286 | ) | ||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||
| Net proceeds from sale of common stock | 24,907,781 | 12,209,021 | ||||
| Purchase of common stock | (1,012,000 | ) | - | |||
| Net cash provided by financing activities | 23,895,781 | 12,209,021 | ||||
| Impact on cash from foreign currency translation | (29,220 | ) | (61,278 | ) | ||
| NET INCREASE IN CASH | 17,315,628 | 7,196,457 | ||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 6,995,525 | 186,204 | ||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 24,311,153 | $ | 7,382,661 | ||
| 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 | $ | - | ||
| Cashless exercise of warrants | $ | 2 | $ | - | ||
| Issuance of warrants to placement agents | $ | - | $ | 247,452 | ||
| Issuance of common stock issuable | $ | - | $ | 3,084,000 |
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