INmune Bio Inc INMB

RE:RE:RE:RE:RE:Just the beginning

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https://www.inmunebio.com/index.php/en/news-2/2021/449-muneioncnnouncesourthuarterandullear20220210304
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INmune Bio, Inc. Announces Fourth Quarter and Full Year 2020 Results and Provides Business Update

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: https://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 [phone]
[e-mail]

Investor Contact:
Chuck Padala
LifeSci Advisors
[phone]
[e-mail]

Media Contact:
Meredith Sosulski, Ph.D.
LifeSci Communications
[phone]
[e-mail]

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

 

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