INmune Bio, Inc. Announces Fourth Quarter and Full Year 2020 Results and Provides Business Update

INmune Bio, Inc.
·11 min read

Company to host conference call today, March 4, at 4:30pm ET

LA JOLLA, Calif., March 04, 2021 (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 year ended December 31, 2020 and provided a business update.

“A key highlight since our last quarterly update is the updated interim data announced from our ongoing Phase 1b study evaluating XPro1595 in Alzheimer’s disease in January,” stated RJ Tesi, M.D., chief executive officer of INmune Bio. “These data demonstrate that XPro1595 decreases neuroinflammation using multiple biomarkers of inflammation in patients with Alzheimer’s disease. We also gained insight into the consequences of decreasing neuroinflammation in these patients for extended period of time which includes decrease in biomarkers on neurodegeneration and improvement of biomarkers of synaptic function. We remain committed to initiating a Phase 2 study later this year.

“Our Phase 2 trial of Quellor for the treatment of for pulmonary complications patients with COVID-19 continues to enroll patients. While the emergence of safe and effective vaccines appears to be having an impact on infection and hospitalization rates, effective treatment of serious complications remains a significant unmet need. Both the TRD program with XPro1595 and the INKmune program to treat patients with high-risk MDS will begin to enroll patients once the pandemic is better controlled in the US and UK, respectively. We look forward to data from these important studies.

“Finally, we strengthened our balance sheet by raising an additional $28.4 million of net proceeds from the sale of 1,439,480 shares of common stock at an average price of $20.17 through our ATM during January and February 2021, which provides additional capital to fund the Company into 2022.”

Recent Corporate Highlights

DN-TNF Platform Highlights:

  • Announced interim Phase 1b data demonstrating that XPro1595 decreased biomarkers of neuroinflammation and neurodegeneration, as measured by multiple analytic platforms in patients with Alzheimer’s disease.

    • Data supports initiation of a blinded, randomized, placebo-controlled Phase 2 study in 2021 to explore the clinical impact of XPro1595 in patients with Alzheimer’s disease.

    • The biomarker data was presented during a Key Opinion Leader webinar on January 21, 2021, a replay of which can be accessed here.

  • Announced that the first patient has been dosed in the company’s Phase 2 trial of Quellor™ for pulmonary complications in COVID-19 patients.

Financial Highlights:

  • Subsequent to the end of the fourth quarter, raised a net of approximately $28.4 million from the sale of 1,439,480 shares of common stock through a pre-existing open sale market agreement (At-the-Market, or ATM) at an average price of $20.17 per share.

Upcoming Milestones:

  • Report on the first 100 patients enrolled in the company’s Quellor trial in COVID-19 which will provide proof-of-concept and inform a “go/no go” decision by the Data Safety Monitoring Board (DSMB).

  • Additional data from the Phase 1b Alzheimer's disease program.

  • Initiate XPro1595 Phase 2 program for Alzheimer's disease in patients with neuro-inflammation.

  • Initiate XPro1595 Phase 2 program for treatment resistant depression.

  • Initiate Phase 1 program with INKmune™ for high-risk MDS.

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.

  • LIVNate Phase 2 program for NASH.

  • INB03 Phase 2 program for MUC4 expressing cancer.

Financial Results for the Year Ended December 31, 2020:

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.

Research and development expense totaled approximately $5.9 million for the year ended December 31, 2020, compared to approximately $3.3 million during the year ended December 31, 2019.

General and administrative expense was approximately $6.3 million for the year ended December 31, 2020, compared to approximately $6.0 million during the year ended December 31, 2019.

As of December 31, 2020, the Company had cash and cash equivalents of approximately $22.0 million and no debt. Subsequent to December 31, 2020, the company raised a net of approximately $28.4 million at an average price of $20.17 per share from its pre-existing ATM facility.

As of March 4, 2021, the Company had approximately 14.9 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: Thursday, March 4, 2021
Time: 4:30 PM Eastern Time
Participant Dial-in: 877-407-0784
Participant Dial-in (international): 201-689-8560

Live Webcast Link: http://public.viavid.com/index.php?id=143196

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through March 11 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13715561.

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.

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 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 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 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
DMoss@INmuneBio.com

Investor Contact:
Chuck Padala
LifeSci Advisors
(646) 627-8390
chuck@lifesciadvisors.com

Media Contact:
Meredith Sosulski, Ph.D.
LifeSci Communications
(929) 469-3851
msosulski@lifescicomms.com

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

INMUNE BIO, INC.

CONSOLIDATED BALANCE SHEETS
(Unaudited)

December 31,
2020

December 31,
2019

ASSETS

CURRENT ASSETS

Cash

$

21,966,883

$

6,995,525

Research and development tax credit receivable

1,686,065

568,139

Other tax receivable

112,684

77,225

Prepaid expenses

220,090

97,623

Prepaid expenses – related party

-

26,266

TOTAL CURRENT ASSETS

23,985,722

7,764,778

Operating lease – right of use asset – related party

156,214

191,543

Acquired in-process research and development intangible assets

16,514,000

16,514,000

TOTAL ASSETS

$

40,655,936

$

24,470,321

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES

Accounts payable and accrued liabilities

$

1,518,113

$

401,989

Accounts payable and accrued liabilities – related parties

33,664

290,102

Deferred liabilities

190,612

-

Operating lease, current liability – related party

33,873

8,288

TOTAL CURRENT LIABILITIES

1,776,262

700,379

Long-term operating lease liability – related party

126,286

160,164

TOTAL LIABILITIES

1,902,548

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, 13,481,283 and 10,770,948 shares issued and outstanding, respectively

13,481

10,771

Additional paid-in capital

72,104,539

44,833,703

Common stock issuable

-

50,000

Accumulated other comprehensive income (loss)

10,708

(8,515

)

Accumulated deficit

(33,375,340

)

(21,276,181

)

TOTAL STOCKHOLDERS’ EQUITY

38,753,388

23,609,778

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$

40,655,936

$

24,470,321


INMUNE BIO, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

2020

2019

REVENUE

$

10,916

$

-

OPERATING EXPENSES

General and administrative

6,321,097

6,016,056

Research and development

5,917,495

3,281,945

Gain on waiver of common stock issuable

-

(1,542,000

)

Total operating expenses

12,238,592

7,756,001

LOSS FROM OPERATIONS

(12,227,676

)

(7,756,001

)

OTHER INCOME

Other income

128,517

77,688

Total other income

128,517

77,688

NET LOSS

$

(12,099,159

)

$

(7,678,313

)

Net loss per common share – basic and diluted

$

(1.01

)

$

(0.75

)

Weighted average number of common shares outstanding – basic and diluted

11,988,492

10,272,641

COMPREHENSIVE LOSS

Net loss

$

(12,099,159

)

$

(7,678,313

)

Other comprehensive (income) loss – foreign currency translation

19,223

(15,044

)

Total comprehensive loss

$

(12,079,936

)

$

(7,693,357

)


INMUNE BIO, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

2020

2019

CASH FLOWS FROM OPERATING ACTIVITIES:

Net loss

$

(12,099,159

)

$

(7,678,313

)

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation

3,112,004

4,096,538

Gain on waiver of common stock issuable

-

(1,542,000

)

Changes in operating assets and liabilities:

Research and development tax credit receivable

(1,117,926

)

24,076

Other tax receivable

(35,459

)

(39,843

)

Joint development cost receivable

-

17,989

Prepaid expenses

(122,467

)

(82,071

)

Prepaid expenses – related party

26,266

(26,266

)

Accounts payable and accrued liabilities

1,116,124

(151,232

)

Accounts payable and accrued liabilities – related parties

(40,677

)

19,557

Deferred liabilities

190,612

-

Operating lease liability – related party

27,036

(23,091

)

Net cash used in operating activities

(8,943,646

)

(5,384,656

)

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

19,223

(15,044

)

NET INCREASE IN CASH

14,971,358

6,809,321

CASH AT BEGINNING OF YEAR

6,995,525

186,204

CASH AT END OF YEAR

$

21,966,883

$

6,995,525

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 common stock issuable

$

50,000

$

3,084,000

Issuance of warrants to placement agents

$

-

$

247,452