Item 8. Financial Statements and Supplementary Data
Item 8. Financial Statements and Supplementary
Data
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
AUDITED FINANCIAL STATEMENTS:
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB ID Number 688 )
F-1
CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 2021 AND 2020 F-2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31, 2021 AND 2020 F-3
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY FOR THE YEARS ENDED DECEMBER 31, 2021 AND 2020 F-4
CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2021 AND 2020 F-5
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS F-6
73
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Stockholders and the Board of Directors
of
INmune Bio, Inc.
Boca Raton, Florida
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheets of INmune Bio, Inc. (the “Company”) as of December 31, 2021 and 2020, the related consolidated statements
of operations and comprehensive loss, changes in stockholders’ equity and cash flows for each of the two years in the period ended
December 31, 2021, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial
statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results
of its operations and its cash flows for each of the two years in the period ended December 31, 2021, in conformity with accounting principles
generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility
of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We
are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal
control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Marcum llp
Marcum llp
We have served as the Company’s auditor since 2017.
Houston, Texas
March 3, 2022
F- 1
INMUNE BIO, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
December 31,
2021
December 31,
2020
ASSETS
CURRENT ASSETS
Cash
$ 74,810
$ 21,967
Research and development tax credit receivable
4,913
1,686
Other tax receivable
591
113
Prepaid expenses
2,278
220
Prepaid expenses – related party
14
-
TOTAL CURRENT ASSETS
82,606
23,986
Operating lease – right of use assets
726
156
Other assets
99
-
Acquired in-process research and development intangible assets
16,514
16,514
TOTAL ASSETS
$ 99,945
$ 40,656
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities
$ 3,733
$ 1,518
Accounts payable and accrued liabilities – related parties
80
34
Deferred liabilities
474
190
Operating lease, current liabilities
72
34
TOTAL CURRENT LIABILITIES
4,359
1,776
Long-term debt, less debt discount
14,458
-
Long-term operating lease liabilities
704
126
Accrued liability – long-term
199
-
TOTAL LIABILITIES
19,720
1,902
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, 17,843,303 and 13,481,283 shares issued and outstanding, respectively
18
13
Additional paid-in capital
143,921
72,105
Accumulated other comprehensive income
1
11
Accumulated deficit
( 63,715 )
( 33,375 )
TOTAL STOCKHOLDERS’ EQUITY
80,225
38,754
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 99,945
$ 40,656
See accompanying notes to these consolidated financial
statements.
F- 2
INMUNE BIO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
FOR THE YEARS ENDED DECEMBER 31, 2021 AND 2020
( In
thousands, except share and per share amounts)
2021
2020
REVENUE
$
181
$
11
OPERATING EXPENSES
General and administrative
8,791
6,321
Research and development
20,543
5,918
Total operating expenses
29,334
12,239
LOSS FROM OPERATIONS
( 29,153 )
( 12,228 )
OTHER (EXPENSE) INCOME
Other (expense) income
( 1,187 )
129
Total other (expense) income
( 1,187 )
129
NET LOSS
$ ( 30,340 )
$ ( 12,099 )
Net loss per common share – basic and diluted
$ ( 1.88 )
$ ( 1.01 )
Weighted average number of common shares outstanding – basic and diluted
16,130,539
11,988,492
COMPREHENSIVE LOSS
Net loss
$ ( 30,340 )
$ ( 12,099 )
Other comprehensive (loss) income – foreign currency translation
( 10 )
20
Total comprehensive loss
$ ( 30,350 )
$ ( 12,079 )
See accompanying notes to these consolidated financial
statements.
F- 3
INMUNE BIO, INC.
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’
EQUITY
FOR THE YEARS ENDED DECEMBER 31, 2021 AND 2020
(In thousands, except share amounts)
Accumulated
Additional
Common
Other
Total
Common Stock
Paid-In
Stock
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Issuable
Income (loss)
Deficit
Equity
Balance as of January 1, 2020
10,770,948
$ 11
$ 44,834
$ 50
$ ( 9 )
$ ( 21,276 )
$ 23,610
Issuance of common stock for cash, net
2,874,600
2
24,905
-
-
-
24,907
Acquisition and retirement of common stock
( 220,000 )
-
( 1,012 )
-
-
-
( 1,012 )
Capital contribution
-
-
216
-
-
-
216
Cashless exercise of warrants
2,400
-
-
-
-
-
-
Issuance of common stock issuable
33,335
-
50
( 50 )
-
-
-
Stock-based compensation
20,000
-
3,112
-
-
-
3,112
Gain on foreign currency translation
-
-
-
-
20
-
20
Net loss
-
-
-
-
-
( 12,099 )
( 12,099 )
Balance as of December 31, 2020
13,481,283
13
72,105
-
11
( 33,375 )
38,754
Issuance of common stock for cash, net
3,970,854
5
80,248
-
-
-
80,253
Settlement of Xencor warrant for cash and common stock
192,533
-
( 15,000 )
-
-
-
( 15,000 )
Warrants issued to lenders as debt inducement
-
-
619
-
-
-
619
Exercise of warrants
15,633
-
18
-
-
-
18
Exercise of stock options
183,000
-
1,135
-
-
-
1,135
Stock-based compensation
-
-
4,796
-
-
-
4,796
Loss on foreign currency translation
-
-
-
-
( 10 )
-
( 10 )
Net loss
-
-
-
-
-
( 30,340 )
( 30,340 )
Balance as of December 31, 2021
17,843,303
$ 18
$ 143,921
$ -
$ 1
$ ( 63,715 )
$ 80,225
See accompanying notes to these consolidated financial
statements.
F- 4
INMUNE BIO, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 2021 AND 2020
(In thousands)
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 30,340 )
$ ( 12,099 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
4,796
3,112
Accretion of debt discount
126
-
Changes in operating assets and liabilities:
Research and development tax credit receivable
( 3,227 )
( 1,118 )
Other tax receivable
( 478 )
( 36 )
Prepaid expenses
( 2,058 )
( 122 )
Prepaid expenses – related party
( 14 )
26
Other assets
( 99 )
-
Accounts payable and accrued liabilities
2,215
1,116
Accounts payable and accrued liabilities – related parties
46
( 40 )
Deferred liabilities
284
191
Accrued liability – long-term
199
-
Operating lease liabilities
46
27
Net cash used in operating activities
( 28,504 )
( 8,943 )
CASH FROM INVESTING ACTIVITIES
Cash paid to Xencor to settle warrant for acquired research and development intangible assets
( 15,000 )
-
Net cash used in investing activities
( 15,000 )
-
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from the issuance of debt
14,951
-
Net proceeds from sale of common stock
80,253
24,907
Net proceeds from the exercise of stock options
1,135
-
Net proceeds from the exercise of warrants
18
-
Purchase of common stock
-
( 1,012 )
Net cash provided by financing activities
96,357
23,895
Impact on cash from foreign currency translation
( 10 )
19
NET INCREASE IN CASH
52,843
14,971
CASH AT BEGINNING OF YEAR
21,967
6,996
CASH AT END OF YEAR
$ 74,810
$ 21,967
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION:
Cash paid for income taxes
$ -
$ -
Cash paid for interest expense
$ 559
$ -
NONCASH INVESTING AND FINANCING ACTIVITIES:
Common stock issued to Xencor to settle warrant issued for acquired research and development intangible assets
$ 3,300
$ -
Warrants issued to lenders as debt inducement
$ 619
$ -
Capital contribution
$ -
$ 216
Issuance of common stock issuable
$ -
$ 50
See accompanying notes to these consolidated financial
statements.
F- 5
INMUNE BIO, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 – ORGANIZATION AND BASIS
OF PRESENTATION
Organization and Business Overview
INmune Bio, Inc. (the “Company” or
“INmune Bio”) was organized in the State of Nevada on September 25, 2015, and is a clinical stage biotechnology pharmaceutical
company focused on developing and commercializing its product candidates to treat diseases where the innate immune system is not functioning
normally and contributing to the patient’s 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 Alzheimer’s and treatment resistant depression (XPro) and cancer (INB03).
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.
Basis of Presentation and Principles of
Consolidation
The accompanying consolidated financial statements
of the Company have been prepared in accordance with Generally Accepted Accounting Principles (“US GAAP”) in the United States
of America and the rules of the Securities and Exchange Commission (“SEC”).
The consolidated financial statements herein have
been prepared in accordance with US GAAP and include the accounts of INmune Bio, its wholly-owned UK subsidiary, and its wholly-owned
Australia subsidiary (collectively, the “Company”). All significant intercompany accounts and transactions have been eliminated.
NOTE 2 – LIQUIDITY
As of December 31, 2021, the Company had an accumulated
deficit of $ 63,715,000 and experienced losses since its inception. Losses have principally occurred as a result of the substantial resources
required for research and development of the Company’s products, which included the general and administrative expenses associated
with its organization and product development as well as the lack of sources of revenues until such time as the Company’s products
are commercialized.
F- 6
To meet its current and future obligations the
Company has taken the following steps to capitalize the business and achieve its business plan:
● During July 2021, the Company completed a registered direct
public offering in which it sold 1,818,182 shares of common stock to investors for estimated net proceeds of $ 36.9 million.
● During June 2021, the Company entered into a loan and security agreement and drew down a $ 15.0 million
term loan.
● During March 2021, the Company entered into a sales agreement with
BTIG, LLC (“BTIG”), as agent, to establish an At-The-Market (“ATM”) offering of up to $ 45 million of common stock
(the “2021 ATM”), subject to certain limitations on the amount of common stock that may be offered and sold by the Company
set forth in the sales agreement. The Company is required to pay BTIG a commission of 3 % of the gross proceeds from the sale of shares.
The Company has sold 713,192 shares of its common stock at an average price of $ 21.73 through the 2021 ATM for net proceeds of $ 14.9 million.
● During April 2020, the Company entered into a sales agreement with
BTIG, as sales agent, to establish an ATM offering to sell up to $ 10.0 million of the Company’s common stock (the “2020 ATM”).
In August 2020, the sales agreement was amended whereby the aggregate offering was increased from $ 10.0 million to $ 30.0 million. From
April 2020 through December 2020, the Company sold 178,600 shares of common stock at an average price of $ 5.45 per share for net proceeds
of approximately $ 0.8 million. During the year ended December 31, 2021, the Company sold in aggregate 1,439,480 shares on common stock
at an average price of $ 20.17 per share for net proceeds of $ 28.4 million. As of December 31, 2021, sales of our common stock pursuant
to the 2020 ATM have been completed.
Although it is difficult to predict the Company’s
liquidity requirements, as of December 31, 2021, and based upon the Company’s current operating plan, the Company believes that
it will have sufficient cash to meet its projected operating requirements for at least the next 12 months following the filing date of
this Annual Report on Form 10-K based on the balance of cash available as of December 31, 2021. The Company anticipates that it will continue
to incur net losses for the foreseeable future as it continues the development of its clinical drug candidates and preclinical programs
and incurs additional costs associated with being a public company.
NOTE 3 – SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES
Use of Estimates
Preparing financial statements in conformity with
US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses.
Actual results and outcomes may differ from management’s estimates and assumptions.
Risks and Uncertainties
The Company is subject to risks and uncertainties
as a result of the COVID-19 pandemic. The extent of the impact of the COVID-19 pandemic on the Company’s business is highly uncertain
and difficult to predict. Also, economies worldwide have also been negatively impacted by the COVID-19 pandemic, however policymakers
around the globe have responded with fiscal policy actions to support the healthcare industry and economy as a whole. The magnitude and
overall effectiveness of these actions remain uncertain.
In addition, the Company’s clinical trials
have been affected by and may continue to be affected by the COVID-19 pandemic. Clinical site initiation and patient enrollment have and
may continue to be delayed due to prioritization of hospital resources toward the COVID-19 pandemic. Some patients have not and others
may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services. Similarly,
the ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened
exposure to COVID-19, may adversely impact the Company’s clinical trial operations.
The severity of the impact of the COVID-19 pandemic
on the Company’s business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic
and the extent and severity of the impact on the Company’s service providers, suppliers, contract research organizations (“CROs”)
and the Company’s clinical trials, all of which are uncertain and cannot be predicted. As of the date of issuance of Company’s
financial statements, the extent to which the COVID-19 pandemic may materially impact the Company’s financial condition, liquidity
or results of operations is uncertain.
Cash and Cash Equivalents
The Company considers all highly liquid instruments purchased with
an original maturity of three months or less to be cash equivalents. The Company holds cash in banks in excess of Federal Deposit Insurance
Corporation insurance limits. However, the Company believes risk of loss is minimal as the cash is held by large, highly-rated financial
institutions.
F- 7
Research and Development Tax Incentive Receivable
The Company, through its wholly-owned subsidiary
in Australia, participates in the Australian research and development tax incentive program, such that a percentage of our qualifying
research and development expenditures are reimbursed by the Australian government, and such incentives are reflected as a reduction of
research and development expense. The Australian research and development tax incentive is recognized when there is reasonable assurance
that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured.
At each period end, management estimates the reimbursement available to the Company based on available information at the time.
The Company, through its wholly-owned subsidiary
in the United Kingdom, participates in the research and development program provided by the United Kingdom tax relief program, such that
a percentage of our qualifying research and development expenditures are reimbursed by the United Kingdom government, and such incentives
are reflected as a reduction of research and development expense. The United Kingdom research and development tax incentive is recognized
when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the
consideration can be reliably measured. At each period end, management estimates the reimbursement available to the Company based on available
information at the time.
Intangible Assets
The Company capitalizes costs incurred in connection
with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under
applicable license agreements; patent applications (principally legal fees), patent purchases, and trademarks related to its cell line
as intangible assets. Acquired in-process research and development costs that do not have alternative uses are expensed as incurred. When
the assets are determined to have a finite life (upon completion of the development of the in-process research and development for its
DN-TNF platform), the useful life will be determined and the in-process research and development intangible assets will be amortized.
During the fourth quarter and if business factors
indicate more frequently, the Company performs an assessment of the qualitative factors affecting the fair value of our in-process research
and development. If the qualitative assessment suggests that impairment is more likely than not, a quantitative analysis is performed.
The quantitative analysis involves a comparison of the fair value of the in-process research and development with the carrying amount.
If the carrying amount of the in-process research and development exceeds its fair value, an impairment loss is recognized in an amount
equal to that excess. During the years ended December 31, 2020 and 2021, the Company performed a qualitative assessment of its in-process
research and development and determined that there was no impairment.
Basic and Diluted Loss per Share
Basic loss per share is computed by dividing net
loss available to common shareholders by the weighted average number of outstanding common shares during the period. Diluted loss per
share gives effect to all dilutive potential common shares outstanding during the period. Dilutive loss per share excludes all potential
common shares if their effect is anti-dilutive. For all periods presented, there is no difference in the number of shares used to calculate
basic and diluted shares outstanding due to the Company’s net loss position.
At December 31, 2021, the Company had 4,097,000
potentially issuable shares of common stock upon the exercise of stock options and 93,866 potentially issuable shares of common stock
upon the exercise of warrants.
At December 31, 2020, the Company had 3,457,000
potentially issuable shares of common stock upon the exercise of stock options and 1,955,922 potentially issuable shares of common stock
upon the exercise of warrants.
Revenue Recognition
The Company recognizes revenue when the customer
obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange
for those goods or services. The Company recognizes revenue following the five-step model prescribed under ASC Topic 606: (1) identify
contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate
the transaction price to the performance obligations in the contract; and (5) recognize revenues when (or as) the Company satisfies the
performance obligations. The Company records the expenses related to revenue in research and development expense, in the periods such
expenses were incurred.
F- 8
The Company records deferred revenues when cash
payments are received or due in advance of performance, including amounts which are refundable.
The Company’s 2021 revenues were from the
sale of MSC’s to three customers. The sales were recognized when the MSC’s were delivered to the customers.
The Company’s 2020 revenue was from the
sale of MSC’s to one customer. The revenue was recognized when the MSC’s were delivered to the customer.
Stock-Based Compensation
The Company utilizes the Black-Scholes option
pricing model to estimate the fair value of stock option awards at the date of grant, which requires the input of highly subjective assumptions,
including expected volatility and expected life. Changes in these inputs and assumptions can materially affect the measure of estimated
fair value of our share-based compensation. These assumptions are subjective and generally require significant analysis and judgment to
develop. When estimating fair value, some of the assumptions will be based on, or determined from, external data and other assumptions
may be derived from our historical experience with stock-based payment arrangements. The appropriate weight to place on historical experience
is a matter of judgment, based on relevant facts and circumstances. The Company accounts for forfeitures of stock options as they occur.
Research and Development
Research and development (“R&D”)
costs are expensed as incurred. Research and development credits are recorded by the Company as a reduction of research and development
costs. Major components of research and development costs include cash compensation, stock-based compensation, costs of preclinical studies,
clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead
costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development
activities on the Company’s behalf.
The Company recognizes grants as contra research
and development expense in the consolidated statement of operations on a systematic basis over the periods in which the entity recognizes
as expenses the related costs for which the grants are intended to compensate.
Income Taxes
The Company follows the liability method of accounting
for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable
to differences between the financial statement carrying values and their respective income tax basis (temporary differences). The effect
on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment
date.
Foreign Currency Translation
The Company’s financial statements are presented
in the U.S. dollar (“$”), which is the Company’s reporting currency, while its functional currencies are the U.S. Dollar
for its U.S. based operations, British Pound (“GBP”) for its United Kingdom-based operations and Australian Dollars (“AUD”)
for its Australian-based operations. All assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders’
equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the
period. The resulting translation adjustments are reported under other comprehensive income. Gains and losses resulting from the translations
of foreign currency transactions and balances are reflected in the statement of operations and comprehensive loss.
Recently Adopted Accounting Pronouncements
There were various accounting standards and interpretations
issued recently, none of which are expected to a have a material impact on the Company´s consolidated financial position, operations,
or cash flows.
F- 9
Reclassifications
Certain amounts from the prior period have been
adjusted to conform to the current period presentation.
Subsequent Events
The Company has evaluated all transactions through
the financial statement issuance date for subsequent disclosure consideration.
NOTE 4 – RESEARCH AND DEVELOPMENT
ACTIVITY
According to UK tax law, the Company is allowed
an R&D tax credit that reduces a company’s tax bill in the UK for expenses incurred in R&D subject to certain requirements.
The Company’s UK subsidiary submits R&D tax credit requests annually for research and development expenses incurred. At December
31, 2021 and 2020, the Company recorded a research and development tax credit receivable of $ 3,319,000 and $ 833,000 , respectively for
R&D expenses incurred in the UK. During the years ended December 31, 2021 and 2020, the Company received $ 814,000 and $ 306,000 of
R&D tax credit reimbursements, respectively from the UK.
According to AUS tax law, the Company is allowed
an R&D tax credit that reduces a company’s tax bill in AUS for expenses incurred in R&D subject to certain requirements.
The Company’s Australian subsidiary submits R&D tax credit requests annually for research and development expenses incurred.
At December 31, 2021 and 2020, the Company recorded a research and development tax credit receivable of $ 1,594,000 and $ 853,000 , respectively,
for R&D expenses incurred in Australia. During the years ended December 31, 2021 and 2020, the Company received $ 1,296,000 and $ 178,000
of R&D tax credit reimbursements, respectively from Australia.
Xencor, Inc. License Agreement
On October 3, 2017, the Company entered into a
license agreement (“Xencor License Agreement”) with Xencor, Inc. (“Xencor”), which has discovered and developed
a proprietary biological molecule that inhibits soluble tumor necrosis factor. During June 2021, the Company entered into the First Amendment
to License Agreement. Pursuant to the license agreement, Xencor granted the Company an exclusive worldwide, royalty-bearing license in
licensed patent rights, licensed know-how and licensed materials (as defined in the license agreement) to make, develop, use, sell and
import any pharmaceutical product that comprises, contains, or incorporates Xencor’s proprietary protein known as “XPro”
that inhibits soluble tumor necrosis factor (or all modifications, formulations and variants of the licensed protein that specifically
bind soluble tumor necrosis factor) alone or in combination with one or more active ingredients, in any dosage or formulation (“Licensed
Products”). The Company believes the protein has numerous medical applications. Such additional alternative applications of the
technology are available under the Xencor License Agreement. In connection with the Xencor License Agreement, the Company paid Xencor
a one-time non-creditable and non-refundable fee of $ 100,000 and issued Xencor 1,585,000 shares of the Company’s common stock with
a fair value of $ 12,221,000 . In addition, the Company issued Xencor fully vested warrants with a fair value of $ 4,193,000 to purchase
an additional number of shares of common stock equal to 10 % of the fully diluted company shares immediately following such purchase, which
warrant has since been cancelled (see the description below). The aggregate purchase price for the full exercise of the option was $ 10,000,000 .
The Company recorded $ 16,514,000 for the acquisition
of intangible assets for the in-process research and development as the fair value of the cash, stock and warrants on the date of the
License Agreement acquisition in accordance with Accounting Standards Codification 730 – Research and Development . The Company
has the license rights to pursue alternative applications of the technology as part of its future development plans.
The Company also agreed to pay Xencor a royalty
on Net Sales of all Licensed Products in a given calendar year, which are payable on a country-by- country and licensed product by licensed
product basis until the date that is the later of (a) the expiration of the last to expire valid claim covering such Licensed Product
in such country or (b) ten years following the first sale to a third party of the licensed product in such country.
F- 10
Under the Xencor License Agreement, the Company
also agreed to pay Xencor a percentage of any sublicensing revenue that it receives.
On June 10, 2021, the Company and Xencor entered
into an Option Cancellation Agreement whereby Xencor terminated its warrant to purchase 10 % of the fully diluted shares of the Company
in exchange for a cash payment of $ 15,000,000 and 192,533 shares of the Company’s common stock with a fair value of $ 3,300,000 based
on the market price of the common stock as of June 10, 2021, which the Company issued in June 2021. The Company filed a registration statement
covering the resale of these shares during September 2021 and agreed to keep the registration statement continuously effective until all
such shares cease to be outstanding or otherwise cease to be registrable securities as defined in the Option Cancellation Agreement. The
Company charged the cash consideration paid to Xencor to enter into the Option Cancellation Agreement to equity as the fair value of the
warrant immediately prior to the Option Cancellation Agreement was greater than the consideration paid to Xencor.
INKmune License Agreement
On October 29, 2015, the Company entered into
an exclusive license agreement (the “INKmune License Agreement”) with Immune Ventures, LLC (“Immune Ventures”).
Pursuant to the INKmune License Agreement, the Company was granted exclusive worldwide rights to the patents, including rights to incorporate
any improvements or additions to the patents that may be developed in the future. In consideration for the patent rights, the Company
agreed to the following milestone payments:
(in thousands)
Each Phase I initiation
$ 25
Each Phase II initiation
$ 250
Each Phase III initiation
$ 350
Each NDA/EMA filing
$ 1,000
Each NDA/EMA awarded
$ 9,000
During July 2021, the Company initiated a Phase
I clinical trial using INKmune and the Company paid Immune Ventures a $ 25,000 milestone payment.
In addition, the Company agreed to pay the licensor
a royalty of 1 % of net sales during the life of each patent granted to the Company. The License is owned by Immune Ventures. RJ Tesi,
the Company’s President and a member of our Board of Directors, David Moss, its Chief Financial Officer and Treasurer and Mark Lowdell,
its Chief Scientific Officer, are the owners of Immune Ventures. As of December 31, 2021 and December 31, 2020, no sales had occurred
under this license.
The term of the agreement began on October 29,
2015 and, if not terminated sooner pursuant to the agreement, ends on a country-by-country basis on the date of the expiration of the
last to expire patent rights where patent rights exists. Upon the termination of the agreement we shall have a fully paid up, perpetual,
royalty-free license without further obligation to Immune Ventures. The agreement can be terminated by Immune Ventures if, after 60 days
from the Company’s receipt of notice that the Company has not made a payment under the agreement, and the Company still does not
make this payment. On July 20, 2018, the parties amended the agreement under which the Company was required achieve milestones pursuant
to the agreement. On October 30, 2020, the parties executed an additional amendment to the agreement under which the Company is required
to achieve the following milestones:
Initiation of Phase II clinical trials or equivalent
by October 29, 2023
Initiation of Phase III clinical trials or equivalent
by October 29, 2025
Filing of NDA or equivalent by October 29, 2026
or equivalent
If the Company doesn’t achieve the above
milestones, it is required to negotiate in good faith with Immune Ventures to determine how it can either remedy the failure or achieve
an alternate development. If the Company fails to make any required efforts, or if the efforts do not remedy the situation within 60 days
of written notice by Immune Ventures, then Immune Ventures may provide notice to terminate the license or convert it to a non-exclusive
license.
University of Pittsburg License Agreement
On October 3, 2017, the Company entered into an
Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University of Pittsburgh.
Pursuant to the Assignment and Assumption Agreement (“Assignment Agreement”), Immune Ventures assigned all of its rights,
obligations and liabilities under an Exclusive License Agreement between the University of Pittsburgh – Of the Commonwealth System
of Higher Education (“Licensor”) and Immune Ventures to INmune Bio (“Licensee”), (the “PITT Agreement”).
F- 11
Consideration under the PITT Agreement includes:
(i) annual maintenance fees, (ii) royalty payments based on the sale of products making use of the licensed technology, and (iii) milestone
payments.
Annual maintenance fees under the PITT Agreement
include: $5,000 due June 26 of each year 2020-2022; $10,000 due on June 26 of each year 2023-2024; and $25,000 due on June 26 of each
year 2025 and annually thereafter until first commercial sale. The Company had no amounts owed pursuant to the PITT Agreement as of December
31, 2021.
(in thousands)
June 26 of each year 2020-2022
$ 5
June 26 of each year 2023-2024
$ 10
June 26 of each year 2025 until first commercial sale
$ 25
Upon first commercial sale of a product making
use of the licensed technology under the PITT Agreement, the Licensee is required to pay royalties equal to 2.5 % of Net Sales each calendar
quarter. There were no commercial sales of product making use of the licensed
technology under the PITT Agreement in 2021.
Moreover, under the PITT Agreement the Licensee
is required to make milestone payments as follows:
(in thousands)
Each Phase I initiation
$ 50
Each Phase III initiation
$ 500
First commercial sale of product making use of licensed technology
$ 1,250
The Company made a $ 50,000 milestone payment in
March 2019 pursuant to the PITT Agreement as a result of a Phase I initiation. The PITT Agreement expires upon the earlier of: (i) expiration
of the last claim of the Patent Rights forming the subject matter of the PITT Agreement; or (ii) the date that is 20 years from the effective
date of the agreement (June 26, 2037).
The Licensee may terminate the PITT Agreement
upon 3 months prior written notice provided all payments under the license are current. The Licensor may terminate the PITT Agreement
upon written notice if: (i) Licensee defaults as to performance of material obligations which have not been cured within 60 days after
receiving written notice; or (ii) Licensee ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to
the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors.
NOTE 5 – LEASE
In May 2019, the Company signed a sublease agreement
with a related party for office space in La Jolla, California, which served as the former headquarters of the Company. The lease has a
61 -month term, which corresponds to the lease term of the lessor. The lessor is CTI Clinical Trial & Consulting Services (“CTI”).
CTI is majority-owned by a member of the Company’s Board of Directors. During 2021, the Company moved its corporate headquarters
to Boca Raton, Florida. The Company intends to sublease its office space in La Jolla.
In September 2021, the Company signed a lease
with a third party for office space in Boca Raton, Florida. The lease agreement has a 64 -month term and commenced during the fourth
quarter of 2021.
F- 12
Below is a summary of the Company’s right-of-use
assets and liabilities:
(in thousands, except years and rate)
December 31,
2021
December 31,
2020
Right-of-use asset (La Jolla lease)
$
118
$
156
Right-of-use asset (Boca Raton lease)
608
-
Total
$
726
$
156
Operating lease, current liability (La Jolla lease)
$
52
$
8
Operating lease, current liability (Boca Raton lease)
20
-
Total
72
8
Long-term operating lease liability (La Jolla lease)
84
160
Long-term operating lease liability (Boca Raton lease)
620
-
704
160
Total lease liability
$
776
$
168
Weighted-average remaining lease term
4.6 years
4.5 years
Weighted-average discount rate
11.70
%
10.00
%
NOTE 6 – RELATED PARTY TRANSACTIONS
UCL
At December 31, 2021 and 2020, the Company owed
UCL Consultants Limited (“UCL”) $ 10,000 and $ 34,000 , respectively, in connection with medical research performed on behalf
of the Company. During the years ended December 31, 2021 and 2020, the Company paid UCL $ 218,000 and $ 335,000 , respectively, for medical
research performed on behalf of the Company. UCL is a wholly owned subsidiary of the University of London. The Company’s Chief Scientific
and Manufacturing Officer is a professor at the University of London.
CTI
During the
year ended December 31, 2021 and 2020, the Company paid CTI $ 0 and $ 127,000 , respectively, for medical research performed on behalf
of the Company. During the year ended December 31, 2020, the Company recorded a capital contribution of $ 216,000 for the forgiveness
of certain accounts payable due to CTI. During the years ended December 31, 2021 and 2020, the Company paid CTI $ 38,000 and $ 25,000 , respectively,
pursuant to its sublease agreement with CTI. See Note 5.
AmplifyBio
During the
year ended December 31, 2021, the Company engaged AmplifyBio to perform certain medical research on behalf of the Company. The CEO of
AmplifyBio is on the Board of Directors of the Company. At December 31, 2021, the Company owed AmplifyBio $ 70,000 . No amounts were paid
to AmplifyBio during 2021. The Company had no transactions with AmplifyBio during 2020.
NOTE
7 – DEBT
On June
10, 2021, the Company entered into a Loan and Security Agreement (the “Term Loan”) with Silicon Valley Bank and SVB Innovation
Credit Fund VIII, L.P., together (the “Lenders”). The Term Loan provides for a $ 15.0 million term loan, of which
the Company borrowed the entire amount on June 10, 2021, and is secured by the Company’s assets. The Term Loan also provides
for the Company to request an additional $ 5.0 million term loan from the Lenders, which may be granted or denied at the sole discretion
of the Lenders.
F- 13
The Company
paid the Lenders $ 47,000 to access the term loan, which has been included as a component of the debt discount and is amortized to
interest expense over the term of the loan. The term loan and debt discount are as follows as of December 31, 2021:
(in thousands)
Term Loan
$ 15,000
Less: debt discount and financing costs, net
( 542 )
Less: current portion
-
Long-term debt
$ 14,458
For the year ended December 31,
2021, the Company recognized interest expense of $ 985,000 related to the Term Loan.
The term
loan repayment schedule provided for interest only payments beginning on July 1, 2021, and continuing for 12 months, followed by monthly
principal and interest payments, starting on July 1, 2022 and continuing through the maturity date of January 1, 2025. During August
2021, the Lenders extended the interest-only period for one year due to the Company achieving an equity milestone as fully defined
in the Term Loan. As a result of achieving the equity milestone, monthly principal and interest payments begin on July 1, 2023. All outstanding
principal and accrued and unpaid interest will be due and payable on the maturity date. The Term Loan provides for an annual interest
rate equal to the greater of (i) the prime rate then in effect as reported in The Wall Street Journal plus 4.50 % and (ii) 7.75 %.
At December 31, 2021, the interest rate was 7.75 %.
The Term
Loan includes a final payment fee equal to 6.5 % of the original principal amount borrowed payable on the earlier of the repayment
of the loan in full and the maturity date. The Company has the option to prepay the outstanding balance of the term loans in full,
subject to a prepayment premium of (i) 3 % of the original principal amount borrowed for any prepayment on or prior to the first anniversary
of the loan, (ii) 2 % of the original principal amount borrowed for any prepayment after the first anniversary and on or before the
second anniversary of the loan or (iii) 1 % of the original principal amount borrowed for any prepayment after the second anniversary
of the loan but before the maturity date.
The expected
repayment of the $ 15.0 million Term loan principal is as follows as of December 31, 2021:
(in thousands,
except years)
2022
$ -
2023
5,833
2024
9,167
Total debt
15,000
Upon the
occurrence of certain events, including but not limited to the Company’s failure to satisfy its payment obligations under the Term
Loan, the breach of certain of its other covenants under the Term Loan, or the occurrence of a material adverse change, the Lenders will
have the right, among other remedies, to declare all principal and interest immediately due and payable, and will have the right to receive
the final payment fee and, if the payment of principal and interest is due prior to maturity, the applicable prepayment fee. The Company
was in compliance with its debt covenants at December 31, 2021.
F- 14
NOTE 8 – STOCKHOLDERS’ EQUITY
Common Stock – At the Market Offerings
During the year ended December 31, 2020, the Company
issued and sold 178,600 shares of common stock at an average price of $ 5.45 per share under the 2020 ATM agreement. The aggregate net
proceeds were approximately $ 0.8 million after BTIG’s commission and other offering expenses.
During the year ended December 31, 2021, the Company
sold 1,439,480 shares of its common stock at an average price of $ 20.17 per share under the 2020 ATM agreement. The aggregate net proceeds
were approximately $ 28.4 million after BTIG’s commission and other offering expenses.
During the year ended December 31, 2021, the Company
sold 713,192 shares of its common stock at an average price of $ 21.73 per share under the 2021 ATM agreement. The aggregate net proceeds
were approximately $ 14.9 million after BTIG’s commission and other offering expenses.
Registered
Direct Offering
During July
2021, the Company completed a registered direct offering whereby the Company sold 1,818,182 shares of its common stock to investors
for gross proceeds of $ 38.0 million (net proceeds of $ 36.9 million).
Underwritten Stock Offering
During July 2020, the Company completed an underwritten
public offering in which it sold 2,500,000 shares of common stock at a public offering price of $ 10.00 per share. The 2,500,000 shares
sold included the full exercise of the underwriters’ option to purchase 326,086 shares at a price of $ 10.00 per share. Aggregate
net proceeds from the underwritten public offering were $ 23.1 million, net of approximately $ 1.9 million in underwriting discounts and
commissions and offering expenses.
Issuance
of shares to Xencor
On June
10, 2021, the Company and Xencor entered into an Option Cancellation Agreement whereby the Company issued 192,533 shares of
its common stock to Xencor (See Note 4).
Lincoln Park
On May 15, 2019, the Company entered into both
a securities purchase agreement and registration rights agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Under
the terms and subject to the conditions of the securities purchase agreement, the Company had the right to sell to Lincoln Park, and Lincoln
Park was obligated to purchase, up to $20.0 million in shares of the Company’s common stock, subject to certain limitations, over
the 24-month period that commenced on May 15, 2019. During the year ended December 31, 2020, the Company issued 196,000 shares of its
common stock to Lincoln Park for approximately $1.0 million of cash.
During April 2021, the Company terminated the
securities purchase agreement with Lincoln Park.
Purchase and retirement of common stock
During January 2020, the Company purchased and
cancelled 220,000 shares of its common stock from a shareholder in exchange for $ 1,012,000 of cash. Immediately following the purchase,
the investor owned less than 10 % of the outstanding common stock of the Company.
F- 15
Common Stock Issued for Services
During July 2020, the Company granted a consultant
50,000 fully vested warrants with a 5 -year term, of which 25,000 warrants had an exercise price of $ 5.50 per share and 25,000 warrants
had an exercise price of $ 10.00 per share. The fair value of these warrants was $ 356,874 based on the Black-Scholes Option Pricing Model
and was recorded within general and administrative expense. The assumptions used for these warrants consist of the exercise prices, expected
dividends of 0 %, expected volatility of 111.67 % based on the trading history of similar companies, risk-free rate of 0.30 % based on the
applicable US Treasury bill rate and an expected life of 5.0 years. During July 2020, the Company issued the consultant 20,000 shares
of common stock and cancelled the 50,000 warrants. The 20,000 shares were issued from the Company’s 2019 Incentive Stock Plan and
had a fair value of approximately $ 230,000 based on the market value of the Company’s common stock on the grant date. The Company
accounted for the exchange of the warrants for shares of common stock as a modification and recorded no additional expense in connection
with the exchange as the fair value of warrants exceeded the fair value of the shares issued.
Settlement
In 2016, the Company entered into a settlement
agreement whereby the Company agreed to issue 33,335 shares of the Company’s common stock to an individual to settle a claim in
full. During 2020, the Company issued the 33,335 shares.
Stock options
During September 2020, the Company granted an
employee an option to purchase 40,000 shares of its common stock pursuant to the 2019 Incentive Stock Plan. The stock options vest over
four years and had a fair value of $ 339,731 that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes
option-pricing model include: (1) discount rate of 0.46 % based on the applicable US Treasury bill rate (2) expected life of 6.25 years,
(3) expected volatility of approximately 106 % based on the trading history of similar companies, and (4) zero expected dividends.
During 2021, the Company granted various employees,
consultants and directors options to purchase 823,000 shares of common stock pursuant to the 2021, 2019 and 2017 Incentive Stock Plans.
The stock options vest over zero to four years and had a fair value of $ 14,027,000 that was calculated using the Black-Scholes option-pricing
model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 0.78 -1. 49 %% based on the applicable US Treasury
bill rate (2) expected life of 6.00 - 10.00 years, (3) expected volatility of approximately 105 %- 114 % based on the trading history of similar
companies, and (4) zero expected dividends.
F- 16
The following table summarizes stock option activity:
(in thousands, except share and per share amounts)
Number
of
Shares
Weighted-
average
Exercise
Price
Weighted-
average
Remaining
Contractual
Term
(years)
Aggregate
Intrinsic
Value
Outstanding at January 1, 2020
3,417,000
$ 5.77
9.03
-
Options granted
40,000
$ 10.38
-
-
Options exercised
-
$ -
-
-
Options cancelled
-
$ -
-
-
Outstanding at January 1, 2021
3,457,000
$ 5.82
8.05
-
Options granted
823,000
$ 20.63
10.0
-
Options exercised
( 183,000 )
$ 6.21
-
-
Options cancelled
-
$ -
-
-
Outstanding at December 31, 2021
4,097,000
$ 8.67
7.21
$ 14,414
Exercisable at December 31, 2021
2,743,760
$ 6.45
6.91
$ 10,890
The Company
received $ 1,135,000 in cash proceeds from exercises of stock options during the year ended December 31, 2021.
During the years ended December 31, 2021 and 2020,
the Company recognized stock-based compensation expense of $ 4,796,000 and $ 2,755,000 , respectively, related to stock options. As of December
31, 2021, there was $ 13,308,000 of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized
over a weighted-average period of 2.52 years.
Warrants
The Company
issued 45,386 warrants to the Company’s lenders upon obtaining its loan in June 2021. The warrants have a 10-year term
and an exercise price of $ 14.05 . The warrants have a fair value of approximately $ 0.6 million that was calculated using the Black-Scholes
option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 1.45 % based on the applicable
US Treasury bill rate (2) expected life of 10.0 years, (3) expected volatility of approximately 103 % based on the trading
history of similar companies, and (4) zero expected dividends. At December 31, 2021, the intrinsic value of these warrants is
$ 0 .
In connection
with the Company’s initial public offering in February 2019, the Company issued warrants to the placement agents to purchase the
Company’s common stock at an exercise price of $ 9.60 per common share, which warrants are exercisable until December 19, 2023. During
the year ended December 31, 2021, 6,147 of these warrants were exercised on a cashless basis in exchange for 3,758 shares
of common stock. At December 31, 2021, 28,688 of these warrants are outstanding and the intrinsic value is $ 17,000 .
On June
30, 2017, the Company issued fully vested warrants to purchase 31,667 shares of the Company’s common stock to a third
party in conjunction with the common stock sold for cash. The warrants have a $ 1.50 exercise price and expire on June 30, 2022 .
During the year ended December 31, 2021, 11,875 of these warrants were exercised for cash proceeds of $ 18,000 . At December 31,
2021, 19,792 of these warrants are outstanding, with an intrinsic value of $ 172,000 .
Stock-based Compensation by Class of Expense
The following summarizes the components of stock-based
compensation expense in the consolidated statements of operations for the years ended December 31, 2021 and 2020 respectively:
Year Ended
December 31,
2021
Year Ended
December 31,
2020
Research and development
$ 1,651,000
$ 583,000
General and administrative
3,145,000
2,529,000
Total
$ 4,796,000
$ 3,112,000
F- 17
Shareholder Rights Agreement
On December 30, 2020, the Board of Directors (the
“Board”) of the Company approved and adopted a Rights Agreement, dated as of December 30, 2020, by and between the Company
and VStock Transfer, LLC, as rights agent, pursuant to which the Board declared a dividend of one preferred share purchase right (each,
a “Right”) for each outstanding share of the Company’s common stock held by stockholders as of the close of business
on January 11, 2021. When exercisable, each right initially would represent the right to purchase from the Company one one-thousandth
of a share of a newly designated series of preferred stock, Series A Junior Participating Preferred Stock, par value $0.001 per share,
of the Company, at an exercise price of $300.00 per one one-thousandth of a Series A Junior Participating Preferred Share, subject to
adjustment. Subject to various exceptions, the Rights become exercisable in the event any person (excluding certain exempted or grandfathered
persons) becomes the beneficial owner of twenty percent or more of the Company’s common stock without the approval of the Board.
The Rights Agreement was scheduled to expire on December 30, 2021 but was extended until December 30, 2022 by the Board.
Preferred Stock
In 2020, the Company designated 45,000 shares
of its preferred stock with par value of $ 0.001 per share as Series A Junior Participating Preferred Stock. The remaining 9,955,000 shares
of preferred stock with par value of $ 0.001 remain undesignated. None of the preferred shares were issued and outstanding at December 31,
2021 and 2020.
NOTE 9– INCOME TAXES
The provision for income taxes consists of the
following components:
December 31,
2021
December 31,
2020
Current expense (benefit)
$ -
$ -
Federal
-
-
Foreign
-
-
Current income tax expense
-
-
Deferred expense (benefit)
-
-
Federal
-
-
Foreign
-
-
Deferred income tax
-
-
Net deferred taxes
$ -
$ -
A reconciliation of income tax benefit computed
using the federal statutory income tax rate to the Company’s tax expense is as follows:
(in thousands, except percentage)
December 31,
2021
December 31,
2020
Federal tax benefit at statutory rate (21%)
$ ( 6,381 )
$ ( 2,541 )
Stock-based compensation
1,156
599
State income tax benefit, net of federal tax effect
( 519 )
( 411 )
Foreign tax differential
( 41 )
( 61 )
Research credits
2,372
742
Other
2
1
Return to provision adjustment
166
33
Change in valuation allowance
3,245
1,638
Income tax benefit
$ -
$ -
F- 18
The principal components of deferred tax assets
and liabilities consist of the following at December 31, 2021 and 2020, respectively:
(in thousands)
December 31,
2021
December 31,
2020
Deferred tax assets
Stock-based compensation
$ 934
$ 563
Federal NOL carryforwards
3,702
2,202
Foreign NOL carryforwards
2,156
782
Total deferred tax assets
6,792
3,547
Less valuation allowance
( 6,792 )
( 3,547 )
Net deferred tax assets
$ -
$ -
At December 31, 2021, the Company had a federal
net operating loss carryforward of approximately $ 15.7 million. The net operating loss carryforwards for 2017 will begin to expire in
the year ending December 31, 2037 . The net operating loss carryforwards starting in 2018 have no expiration.
The Company’s gross deferred tax assets
of $ 6.8 million and $ 3.5 million at December 31, 2021 and 2020, respectively, primarily consist of net operating loss carryforwards for
income tax purposes. A valuation allowance is required to be recorded when it is not more likely than not that some portion or all of
the net deferred tax assets will be realized. Since the Company cannot be assured of generating taxable income and thereby realizing the
net deferred tax assets, a full valuation allowance has been recorded. The change in the valuation allowance was $ 3,245,000 during
the year ended December 31, 2021.
The Company recognizes uncertain tax positions
in accordance with ASC 740 on the basis of evaluating whether it is more likely than not that the tax positions will be sustained upon
examination by tax authorities. For those tax positions that meet the more-likely-than not recognition threshold, we recognize the largest
amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement. As of December 31, 2021, and 2020,
the Company has no significant uncertain tax positions. There are no unrecognized tax benefits included on the balance sheet that would,
if recognized, impact the effective tax rate. The Company does not anticipate there will be a significant change in unrecognized tax benefits
within the next 12 months.
NOTE 10 – COLLABORATIVE AGREEMENTS
During the year ended December 31, 2020, the Company
was awarded a $500,000 grant from the Amyotrophic Lateral Sclerosis (“ALS”) Association to fund a study of the efficacy of
XPro to reverse ALS in vitro and to fund a study of the efficacy of XPro to protect against ALS model phenotypes in vivo. During the years
ended December 31, 2021 and 2020, the Company received $ 200,000 , and $ 300,000 , respectively of cash proceeds pursuant to this grant which
the Company recorded as deferred liabilities. The Company records costs incurred related to the ALS study as a reduction of the deferred
liabilities. As of December 31, 2021, the Company has $ 257,000 recorded as deferred liabilities related to the ALS grant.
During September 2020, the Company was awarded
a grant of up to $2.9 million from the National Institutes of Health (“NIH”). The grant will support a Phase 2 study of XPro
in patients with treatment resistant depression. As of December 31, 2021, the Company has not received any proceeds pursuant to this grant.
NOTE
11 – COMMITMENTS AND CONTINGENCIES
Lease
In May 2019,
the Company signed a sublease agreement with a related party for office space in La Jolla, California. The lease has a 61-month term,
which corresponds to the lease term of the lessor. The lessor is CTI.
During September
2021, the Company signed a lease agreement with a third party for office space in Boca Raton, Florida. The lease agreement has a 64-month
term and commenced during the fourth quarter of 2021.
Future minimum payments pursuant
to the leases are as follows:
(in thousands,
except years)
2022
$ 170
2023
237
2024
220
2025
193
2026
199
Thereafter
17
Total lease payments
1,036
Less: imputed interest
( 260 )
Present value of future lease payments
776
Less: operating lease, current liabilities
( 72 )
Long-term operating lease liabilities
$ 704
During the years ended December 31, 2021 and 2020,
the Company recognized $ 102,000 and $ 52,000 , respectively, in operating lease expense, which is included in general and administrative
expenses in the Company’s consolidated statement of operations.
F- 19
Litigation
The Company
is subject to claims and suits that arise from time to time in the ordinary course of our business. Although management currently believes
that resolving claims against the Company, individually or in aggregate, will not have a material adverse impact in the Company’s
consolidated financial statements, these matters are subject to inherent uncertainties and management’s view of these matters may
change in the future.
Item 9. Changes in and Disagreements with Accountants
on Accounting and Financial Disclosure
None.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.