0001213900-19-015549.txt : 20190813 0001213900-19-015549.hdr.sgml : 20190813 20190813163623 ACCESSION NUMBER: 0001213900-19-015549 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20190812 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190813 DATE AS OF CHANGE: 20190813 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Inmune Bio, Inc. CENTRAL INDEX KEY: 0001711754 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 475205835 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38793 FILM NUMBER: 191021184 BUSINESS ADDRESS: STREET 1: 1200 PROSPECT STREET STREET 2: SUITE 525 CITY: LA JOLLA STATE: CA ZIP: 92037 BUSINESS PHONE: 8589643720 MAIL ADDRESS: STREET 1: 1200 PROSPECT STREET STREET 2: SUITE 525 CITY: LA JOLLA STATE: CA ZIP: 92037 8-K 1 f8k081219_inmunebio.htm FORM 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 12, 2019

 

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.)

 

1224 Prospect Street, Suite 150, La Jolla, 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)
  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
  Pre-commencement 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).

 

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

 

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.

 

 

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On August 12, 2019, the Company issued a press release announcing the Company’s financial and operating results for the first quarter ended June 30, 2019. 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, dated August 12, 2019

  

 

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.

 

  INMUNE BIO INC.  
     
Date: August 13, 2019 By: /s/ David Moss  
    David Moss  
    Chief Financial Officer  

 

 

2 

EX-99.1 2 f8k081219ex99-1_inmunebio.htm PRESS RELEASE, DATED AUGUST 12, 2019

Exhibit 99.1

 

INmune Bio Reports Second Quarter 2019 Financial Results and Provides Shareholder Update

 

La Jolla, CA – August 12, 2019 – INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), an immunology company focused on 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, 2019 and is providing a business update for the year-to-date.

 

2019 Year-to-Date Corporate Highlights:

·INmune Bio’s management team rang the NASDAQ closing bell on Tuesday, April 9, 2019, to celebrate the Company’s successful initial public offering (“IPO”) in February 2019.
·In May, the Company closed a private placement of approximately $4.7M of Common Stock priced led by Insiders and existing shareholders.
·The Company published data on INmune Bio’s INB16 (INKmune) cell line in peer-reviewed journal PLOS ONE.
·Reported positive preliminary data from INB03 Phase I clinical trial in cancer followed by a final report later this year as the Company advances the program into a Phase II study.
·Edguardo (Ed) Baracchini a biotech business development veteran joined the board of directors.

 

“This year we remained focused on advancing our pipeline,” stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “More recently we announced we have begun planning a Phase II trial for INB03 after receiving positive preliminary data from its clinical Phase I study. This preliminary data has allowed us to move forward with the development of INB03 as a combination immunotherapy for patients with cancer. We anticipate our full data set to be reported later this year followed by a Phase II study.”

 

Our clinical programs continue to advance:

·Received preliminary positive data on INB03’s Phase I study in patients with advanced solid tumors. The trial was successful in determining, in order of priority, the safety of INB03 in cancer patients, the adequate dosage of INB03, and evidence of a biologic effect, as the Company begins planning a Phase II trial in cancer patients using INB03 as part of their combination immunotherapy. The target INB03 trough level was reached in three of three patients in the 1.0 mg/kg group. The inflammatory cytokine IL6, a biomarker of soluble TNF function, decreased by more than 50% in half of the patients, suggesting a pharmacodynamic effect of INB03.

 

·INmune anticipates it will start patient enrollment in the Phase I study of XPro1595 for the treatment of Alzheimer’s disease and INKmune, INmune Bio’s NK cell therapy focused on eliminating residual disease after cancer therapy, in the second half of 2019.

 

Financial Results for the Second Quarter Ended June 30, 2019:

Net loss attributable to common stockholders for the second quarter ended June 30, 2019 was $0.4 million, compared to $6.2 million for the quarter ended June 30, 2018. Net loss incurred during the quarter ended June 30, 2019 included a noncash waiver of common stock issuable of $1.5 million partially offset by noncash stock-based compensation expense of $1.0 million.

 

Research and development expense totaled approximately $0.3 million for the second quarter ended June 30, 2019, compared with approximately $0.3 million for the quarter ended June 30, 2018. During the three months ended June 30, 2019, research and development expense included $0.6 million of research and development expense related to clinical trials, partially offset by $0.3 million of grants from the Alzheimer’s Association which the Company recognized as contra research and development expense.

 

General and administrative expense was approximately $1.7 million in the quarter ended June 30, 2019, compared to approximately $5.9 million in the quarter ended June 30, 2018. The $4.2 million decline in general and administrative expense is due to lower noncash stock-based compensation ($1.0 million for the quarter ended June 30, 2019 compared to $5.6 million for the quarter ended March 31, 2018), partially offset by higher general and administrative expenses including investor relations and payroll expense.

 

 

At June 30, 2019, the Company had cash and cash equivalents of approximately $9.4 million with no debt. In May, the Company closed a private placement of approximately $4.7 million of Common Stock led by insiders and existing shareholders.

 

As of August 9, 2019 the Company had 10.8 million common and 13.9 million fully diluted shares outstanding.

 

About INmune Bio, Inc.

INmune Bio, Inc. is a publicly traded (NASDAQ: INMB) clinical-stage biotechnology company developing therapies targeting the innate immune system to fight disease. INmune Bio is developing three product platforms: two products that reengineer the patient’s innate immune system’s response to cancer and one product to treat neuroinflammation that is currently focused on Alzheimer’s disease. INKmune is a natural killer (NK) cell therapeutic that primes the patient’s NK cells to attack minimal residual disease, the remaining cancer cells that are difficult to detect, which often cause relapse. INB03 inhibits myeloid-derived suppressor cells (MDSC), which often cause resistance to immunotherapy, such as anti-PD-1 checkpoint inhibitors. XPro1595 targets neuroinflammation, which causes microglial activation and neuronal cell death. 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
Statements in this press release relating to our drug candidates and our ability to optimize our opportunities for growth and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. 


This release contains “forward-looking statements” Forward-looking statements reflect our current view about future events. When used in this release, 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 management, identify forward-looking statements. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us; competition from other providers and products; our ability to develop and commercialize products and services; changes in government regulation; and other factors relating to our industry, our operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned.

 

Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements. For a more detailed description of the risk factors and uncertainties affecting the Company please refer to the Company’s recent Securities and change Commission filings, which are available at https://www.sec.gov/cgi-bin/browse-edgar?company=inmune&owner=exclude&action=getcompany. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless otherwise required by law.

 

INmune Bio Contact:

David Moss, CFO

(858) 964-3720

DMoss@INmuneBio.com

 

Media Contact:

Antenna Group

Sharon Golubchik

(201) 465-8008

INmuneBio@AntennaGroup.com

 

Investor Contact: 
KCSA Strategic Communications
Valter Pinto / Daniela Guerrero 
PH: (212) 896-1254 / (347) 487-6187

INmune@KCSA.com

-2- 

 

 

The following table summarizes our results of operations for the periods indicated:

 

INmune Bio, Inc.

BALANCE SHEETS

(Unaudited)

 

   As of 
  

June 30,

2019

  

December 31,

2018

 
         
ASSETS  
Current assets:          
Cash and cash equivalents  $9,363,964   $186,204 
Research and development tax credit receivable   843,687    592,215 
Other tax receivable   104,697    37,382 
Joint development cost receivable   49,329    17,989 
Prepaid expenses   200,024    15,552 
Prepaid expenses – related party   244,882    - 
Total current assets   10,806,583    849,342 
           
Operating lease – right of use asset – related party   209,234    - 
Acquired in-process research and development intangible assets   16,514,000    16,514,000 
Total assets  $27,529,817   $17,363,342 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable and accrued liabilities  $438,217   $553,221 
Accounts payable and accrued liabilities – related parties   69,891    270,545 
Operating lease, current liability – related party   7,530    - 
Total current liabilities   515,638    823,766 
           
Long-term operating lease liability – related party   177,051    - 
Total liabilities   692,689    823,766 
           
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, 10,762,473 and 8,719,441 shares issued and outstanding, respectively   10,762    8,719 
Additional paid-in capital   42,686,569    25,446,196 
Common stock issuable   50,000    4,676,000 
Accumulated other comprehensive income (loss)   (19,207)   6,529 
Accumulated deficit   (15,890,996)   (13,597,868)
Total stockholders’ equity   26,837,128    16,539,576 
Total liabilities and stockholders’ equity  $27,529,817   $17,363,342 

 

 

-3

 

INmune Bio, Inc.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

  

For the Three Months

Ended June 30,

  

For the Six Months

Ended June 30,

 
   2019   2018   2019   2018 
Revenue  $ -   $ -   $ -   $ - 
Operating expenses:                    
Research and development   293,812    287,316    395,404    391,327 
General and administrative   1,676,611    5,886,547    3,486,106    8,628,920 
Waiver of common stock issuable   (1,542,000)   -    (1,542,000)   - 
Total operating expenses   428,423    6,173,863    2,339,510    9,020,247 
Loss from operations   (428,423)   (6,173,863)   (2,339,510)   (9,020,247)
Other income:                    
Interest income   36,340    -    46,382    - 
Total   36,340    -    46,382    - 
Net loss  $(392,083)  $(6,173,863)  $(2,293,128)  $(9,020,247)
Basic and diluted loss per common share  $(0.04)  $(0.71)  $(0.23)  $(1.04)
Weighted average common shares outstanding, basic and diluted   10,150,810    8,719,441    9,771,833    8,633,253 
                     
COMPREHENSIVE LOSS                    
Net loss  $(392,083)  $(6,173,863)  $(2,293,128)  $(9,020,247)
Other comprehensive loss – loss on foreign currency translation   (25,014)   (30,040)   (25,736)   (15,610)
                     
Total comprehensive loss  $(417,097)  $(6,203,903)  $(2,318,864)  $(9,035,857)

 

-4

 

 

INmune Bio, Inc.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

  

For the Six Months

Ended June 30,

 
   2019   2018 
Cash flows from operating activities:          
Net loss  $(2,293,128)  $(9,020,247)
Adjustments to reconcile net loss to:          
Net cash used in operating activities:          
Stock-based compensation   1,949,395    8,066,986 
Waiver of common stock issuable   (1,542,000)   - 
Changes in operating assets and liabilities:          
Research and development tax credit receivable   (251,472)   (155,816)
Other tax receivable   (67,315)   63,774 
Joint development cost receivable   (31,340)   109,124 
Prepaid expenses   (184,472)   (208,344)
Prepaid expenses – related party   (244,882)   112,218 
Accounts payable and accrued liabilities   (376,529)   22,534 
Accounts payable and accrued liabilities – related parties   60,871    (136,917)
Operating lease liability – related party   (24,653)   - 
Net cash used in operating activities   (3,005,525)   (1,146,688)
           
Cash flows from financing activities:          
Net proceeds from sale of common stock   12,209,021    900,000 
Net cash provided by financing activities   12,209,021    900,000 
           
Impact on cash from foreign currency translation   (25,736)   (15,610)
           
Net increase in cash and cash equivalents   9,177,760    (262,298)
Cash and cash equivalents – beginning   186,204    1,370,711 
Cash and cash equivalents – ending  $9,363,964   $1,108,413 
           
Cash paid during the period for:          
Income Taxes  $-   $- 
Interest  $-   $- 
           
Noncash investing and financing activity:          
Issuance of warrants to placement agents  $247,452   $- 
Issuance of common stock issuable  $3,084,000   $- 

 

-5

 

 

 

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