UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2022
or
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ________________ to ________________
Commission
File Number: 001-39336
Aditxt,
Inc.
(Exact
name of registrant as specified in its charter)
Delaware 82-3204328
(State or other jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)
737
N. Fifth Street , Suite 200
Richmond , VA
23219
(Address of principal executive offices) (Zip Code)
(650) 870-1200
(Registrant’s
telephone number, including area code)
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 ADTX The Nasdaq Stock Market LLC
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90 days. Yes
☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☒
If
an emerging growth company, indicate by check mark 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. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
☐ No ☒
As
of May 13, 2022, the registrant had 44,826,641 and 44,725,838 shares of common stock, $0.001 par value per share, issued and outstanding,
respectively.
Table
of Contents
INDEX
Page
No.
Cautionary Note Regarding Forward-Looking Statements and Industry Data
ii
PART I FINANCIAL INFORMATION
Item 1.
Condensed Financial Statements (Unaudited)
1
Condensed Balance Sheets as of March 31, 2022 and December 31, 2021
1
Condensed Statements of Operations for the three months ended March 31, 2022 and 2021
2
Condensed Statements of Stockholders’ Equity for the three months ended March 31, 2022 and 2021
3
Condensed Statements of Cash Flows for the three months ended March 31, 2022 and 2021
5
Notes to Condensed Financial Statements
6
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
16
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
23
Item 4.
Controls and Procedures
23
PART II OTHER INFORMATION
Item 1.
Legal Proceedings
24
Item 1A.
Risk Factors
24
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
24
Item 3.
Defaults Upon Senior Securities
24
Item 4.
Mine Safety Disclosures
24
Item 5.
Other Information
24
Item 6.
Exhibits
25
Signatures
26
i
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
This
Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A
of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,”
“should,” “expects,” “intends,” “plans,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other
comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections
about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually
achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially
from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements
involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:
● we
have generated no significant revenue from commercial sales to date and our future profitability is uncertain;
● if
we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development and
you will likely lose your entire investment;
● our
financial situation creates doubt whether we will continue as a going concern;
● we
may need to raise additional funding, which may not be available on acceptable terms, or at all;
● even
if we can raise additional funding, we may be required to do so on terms that are dilutive to you.;
● the
regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization
of our future product candidates, if any;
● we
may encounter substantial delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate
adequate safety and efficacy to the satisfaction of applicable regulatory authorities;
● if
our future pre-clinical development and future clinical Phase I/II studies are unsuccessful, we may be unable to obtain regulatory approval
of, or commercialize, our product candidates on a timely basis or at all;
● even
if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product and
the revenue that we generate from their sales, if any, may be limited;
● adverse
events involving our products may lead the FDA or applicable foreign regulatory agency to delay or deny clearance for our products or
result in product recalls that could harm our reputation, business and financial results;
● our
technology is subject to licenses from LLU and Stanford (as defined below), each of which are revocable in certain circumstances, including
in the event we do not achieve certain payments and milestone deadlines. Without these licenses, we may not be able to continue to develop
our product candidates;
● if
we were to lose our CLIA certification or state laboratory licenses, whether as a result of a revocation, suspension or limitation, we
would no longer be able to offer our assays (including our AditxtScore™ platform), which would limit our revenues and harm our
business. If we were to lose, or fail to obtain, a license in any other state where we are required to hold a license, we would not be
able to test specimens from those states;
● our
results of operations will be affected by the level of royalty and milestone payments that we are required to pay to third parties;
● we
face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully
than we do;
● our
technologies and products under development, and our business, may fail if we are not able to successfully commercialize them and ultimately
generate significant revenues as a result;
● customers
may not adopt our products quickly, or at all;
● COVID-19
may impact our business and operations;
ii
● the
failure to obtain or maintain patents, licensing agreements and other intellectual property could materially impact our ability to compete
effectively;
● some
of our intellectual property may be subject to “march-in” rights by the U.S. federal government;
● we
do not expect to pay dividends in the foreseeable future;
● we
have issued a significant number of restricted stock awards, restricted stock units, options and warrants and may continue to do so in
the future. The vesting and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder
may dilute your percentage ownership interest and may also result in downward pressure on the price of our common stock;
● future
sales or issuances of substantial amounts of our common stock, including, potentially as a result of the Share Exchange Agreement with
Cellvera Global f/k/a AiPharma Global, could result in significant dilution;
● while
we have entered into a Share Exchange Agreement with Cellvera Global, we cannot assure you that the transaction contemplated by the Share
Exchange Agreement will be consummated or, that if such transaction is consummated, that it will be accretive to stockholder value;
● we
have provided loans to Cellvera Global in the principal amount of $14.5 million, if we are unable to complete the transactions contemplated
by the Share Exchange Agreement, we cannot provide any assurance that we will be able to timely collect such amounts from Cellvera Global,
if at all;
● we
may engage in future acquisitions or strategic transactions, including the transaction with Cellvera Global, which may require us to
seek additional financing or financial commitments, increase our expenses and/or present significant distractions to our management;
● we
received a written notice from Nasdaq that we have failed to comply with certain listing requirements of the Nasdaq Stock Market, which
could result in the delisting of our securities by Nasdaq; and
● exclusive
forum provisions in our amended and restated certificate of incorporation and amended and restated bylaws.
All
of our forward-looking statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ
materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will
prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties
referred to in this Quarterly Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other
documents or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially
and adversely affect our business, prospects, financial condition, and results of operations. Except as required by law, we do not undertake
or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or
projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report on Form
10-Q, even if such results, changes, or circumstances make it clear that any forward-looking information will not be realized. Any public
statements or disclosures by us following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements
contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form
10-Q.
This
Quarterly Report on Form 10-Q may include market data and certain industry data and forecasts, which we may obtain from internal company
surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications,
articles, and surveys. Industry surveys, publications, consultant surveys, and forecasts generally state that the information contained
therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed.
While we believe that such studies and publications are reliable, we have not independently verified market and industry data from third-party
sources.
References
to Aditxt, Inc.
Throughout
this Quarterly Report on Form 10-Q, the “Company,” “Aditxt,” “we,” “us,” and “our”
refers to Aditxt, Inc. and “our board of directors” refers to the board of directors of Aditxt, Inc.
iii
PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements
ADITXT,
INC.
CONDENSED BALANCE
SHEETS
(Unaudited)
March 31,
December 31,
2022
2021
ASSETS
CURRENT ASSETS:
Cash
$ 2,115,206
$ 7,872,061
Accounts receivable
248,777
89,844
Prepaid expenses
534,943
460,102
Note receivable
500,000
500,000
Inventory
1,041,955
494,697
TOTAL CURRENT ASSETS
4,440,881
9,416,704
Fixed assets, net
2,318,247
2,267,297
Intangible assets, net
187,250
214,000
ROU asset - long term
3,883,781
4,097,117
Deposits
446,837
379,250
Other assets
515,104
289,539
TOTAL ASSETS
$ 11,792,100
$ 16,663,907
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses
$ 2,559,122
$ 1,575,543
Financing on fixed assets – current
626,290
700,433
Deferred rent
191,118
186,058
Lease liability - current
1,137,980
1,145,126
TOTAL CURRENT LIABILITIES
4,514,510
3,607,160
Financing on fixed assets - long term
-
110,041
Lease liability - long term
2,554,683
2,765,933
TOTAL LIABILITIES
7,069,193
6,483,134
STOCKHOLDERS’ EQUITY
Preferred stock, $ 0.001 par value, 3,000,000 shares authorized, zero shares issued and outstanding, respectively
-
-
Common stock, $ 0.001 par value, 100,000,000 shares authorized, 44,826,641 and 44,530,486 shares issued and 44,725,838 and 44,429,683 shares outstanding, respectively
44,830
44,534
Treasury stock, 100,803 and 100,803 shares, respectively
( 201,605 )
( 201,605 )
Additional paid-in capital
78,291,632
77,690,653
Accumulated deficit
( 73,411,950 )
( 67,352,809 )
TOTAL STOCKHOLDERS’ EQUITY
4,722,907
10,180,773
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 11,792,100
$ 16,663,907
See
accompanying notes to the condensed financial statements.
1
ADITXT,
INC.
CONDENSED STATEMENTS
OF OPERATIONS
(Unaudited)
Three Months Ended
Three Months Ended
March 31,
2022
March 31,
2021
REVENUE
Sales
$ 210,279
$ -
Cost of goods sold
188,071
-
Gross Profit
22,208
-
OPERATING EXPENSES
General and administrative expenses, including $ 451,987 and $ 1,464,902 , in stock-based compensation, respectively
4,624,158
5,098,517
Research and development expenses, including $ 149,288 , and $ 0 in stock-based compensation, respectively
1,428,382
935,952
Sales and marketing expenses, including $ 0 , and $ 0 in stock-based compensation, respectively
86,599
58,563
Total operating expenses
6,139,139
6,093,032
NET LOSS FROM OPERATIONS
( 6,116,931 )
( 6,093,032 )
OTHER INCOME (EXPENSE)
Interest expense
( 15,210 )
( 16,803 )
Interest income
14,040
249
Other income
58,960
-
Amortization of debt discount
-
( 270,081 )
Total other income (expense)
57,790
( 286,635 )
Net loss before income taxes
( 6,059,141 )
( 6,379,667 )
Income tax provision
-
-
NET LOSS
$ ( 6,059,141 )
$ ( 6,379,667 )
Net loss per share - basic and diluted
$ ( 0.14 )
$ ( 0.30 )
Weighted average number of shares outstanding during the period - basic and diluted
44,580,713
13,829,124
See
accompanying notes to the condensed financial statements.
2
ADITXT,
INC.
CONDENSED STATEMENTS
OF STOCKHOLDERS’ EQUITY
THREE
MONTHS ENDED MARCH 31, 2022 AND 2021
(Unaudited)
Preferred
Shares
Outstanding
Preferred
Shares
Par
Common
Shares
Outstanding
Common
Shares
Par
Treasury
Stock
Additional
Paid-in
Capital
Accumulated
Deficit
Total
Stockholders’
Equity
Balance December 31, 2021
-
$ -
44,429,683
$ 44,534
$ ( 201,605 )
$ 77,690,653
$ ( 67,352,809 )
$ 10,180,773
Stock option and warrant compensation
-
-
-
-
-
219,885
-
219,885
Issuance of restricted stock units for compensation
-
-
287,155
287
-
( 287 )
-
-
Restricted stock unit compensation
-
-
-
-
-
377,671
-
377,671
Issuance of shares for services
-
-
9,000
9
-
3,710
-
3,719
Net loss
-
-
-
-
-
-
( 6,059,141 )
( 6,059,141 )
Balance March 31, 2022
-
$ -
44,725,838
$ 44,830
$ ( 201,605 )
$ 78,291,632
$ ( 73,411,950 )
$ 4,722,907
See
accompanying notes to the condensed financial statements.
3
ADITXT,
INC.
CONDENSED STATEMENTS
OF STOCKHOLDERS’ EQUITY
THREE
MONTHS ENDED MARCH 31, 2022 AND 2021
(Unaudited)
Preferred
Shares
Outstanding
Preferred
Shares
Par
Common
Shares
Outstanding
Common
Shares
Par
Treasury
Stock
Additional
Paid-in
Capital
Accumulated
Deficit
Total
Stockholders’
Equity
Balance December 31, 2020
-
$ -
12,973,692
$ 13,078
$ ( 201,605 )
$ 32,079,187
$ ( 20,879,178 )
$ 11,011,482
Exercise of warrants
-
-
1,163,556
1,164
-
3,717,792
-
3,718,956
Issuance of shares for services
-
-
18,000
18
-
51,222
-
51,240
Issuance of shares for compensation
-
-
335,000
335
-
1,111,865
-
1,112,200
Stock option and warrant compensation
-
-
-
-
-
301,462
-
301,462
Fair value of warrants issued with convertible note payable
-
-
-
-
-
1,322,840
-
1,322,840
Warrant consideration for convertible note offering costs
-
-
-
-
-
231,316
-
231,316
Net loss
-
-
-
-
-
-
( 6,379,667 )
( 6,379,667 )
Balance March 31, 2021
-
$ -
14,490,248
$ 14,595
$ ( 201,605 )
$ 38,815,684
$ ( 27,258,845 )
$ 11,369,829
4
ADITXT,
INC.
CONDENSED STATEMENTS
OF CASH FLOWS
(Unaudited)
Three Months
Ended
Three Months
Ended
March 31,
2022
March 31,
2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 6,059,141 )
$ ( 6,379,667 )
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation
601,275
1,464,902
Depreciation expense
96,852
66,243
Amortization of intangible assets
26,750
26,384
Amortization of debt discount
-
270,081
Changes in operating assets and liabilities:
Prepaid expenses
( 74,841 )
( 233,011 )
Deposits
( 67,587 )
-
Accounts payable and accrued expenses
983,579
731,339
Accounts receivable
( 158,933 )
-
Inventory
( 547,258 )
-
Net cash used in operating activities
( 5,199,304 )
( 4,053,729 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of fixed assets
( 147,802 )
( 486,450 )
Tenant improvement allowance receivable
( 211,661 )
-
Notes receivable and accrued interest
( 13,904 )
-
Net cash used in investing activities
( 373,367 )
( 486,450 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from convertible note payable
-
5,000,000
Discount on convertible note payable from offering costs
-
( 526,460 )
Proceeds from exercise of warrants
-
3,718,956
Payments on financing on fixed asset
( 184,184 )
( 108,107 )
Net cash (used in) provided by financing activities
( 184,184 )
8,084,389
NET (DECREASE) INCREASE IN CASH
( 5,756,855 )
3,544,210
CASH AT BEGINNING OF PERIOD
7,842,061
10,500,826
CASH AT END OF PERIOD
$ 2,115,206
$ 14,045,036
Supplemental cash flow information:
Cash paid for income taxes
$ -
$ -
Cash paid for interest expense
$ -
$ -
NON-CASH INVESTING AND FINANCING ACTIVITIES:
Original offering discount on note payable
$ -
$ 1,000,000
Debt discount from warrants issued with convertible note payable
$ -
$ 1,322,840
Debt discount from warrant consideration for convertible debt offering costs
$ -
$ 231,316
Liability recognized for financed assets
$ -
$ 821,862
See
accompanying notes to the condensed financial statements.
5
ADITXT,
INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
NOTE
1 – ORGANIZATION AND NATURE OF BUSINESS
Company
Background
Overview
Aditxt,
Inc. (“Aditxt” or the “Company”), formerly known as Aditx Therapeutics, Inc., was incorporated in the State of
Delaware on September 28, 2017, and the Company’s headquarters are located in Richmond, VA. The Company is a biotech innovation
company with a mission of prolonging life and enhancing its quality by improving the health of the immune system.
The
Company is developing biotechnologies specifically focused on improving the health of the immune system through immune reprogramming
and monitoring. The Company’s immune reprogramming technologies are currently at the pre-clinical stage and are designed to retrain
the immune system to induce tolerance with an objective of addressing rejection of transplanted organs, autoimmune diseases, and allergies.
The Company’s immune monitoring technologies are designed to provide a personalized comprehensive profile of the immune system,
and the Company plans to utilize them in its upcoming reprogramming clinical trials to monitor subjects’ immune response before,
during and after drug administration.
Offerings
On
August 31, 2021, the Company completed a registered direct offering (“August 2021 Offering”). In connection therewith, the
Company issued 4,583,334 shares of common stock, at a purchase price of $ 2.40 per share, resulting in gross proceeds of
approximately $ 11.0 million. In a concurrent private placement, the Company issued warrants to purchase up to 4,583,334 shares. The
warrants have an exercise price of $ 2.53 per share and are exercisable for a five-year period commencing six months from
the date of issuance. The warrants exercise price was subsequently repriced to $ 1.50 . In addition, the Company issued a warrant
to the placement agent to purchase up to 229,166 shares of common stock at an exercise price of $ 3.00 per share.
On October 18, 2021, the Company entered into
an underwriting agreement with Revere Securities LLC, relating to the public offering (the “October 2021 Offering”) of 2,833,333 shares
of the Company’s common stock (the “Shares”) by the Company. The Shares were offered, issued, and sold at a price to
the public of $ 1.50 per share under a prospectus supplement and accompanying prospectus filed with the SEC pursuant to an effective
shelf registration statement filed with the SEC on Form S-3 (File No. 333-257645), which was declared effective by the SEC on July 13,
2021. The October 2021 Offering closed on October 20, 2021 for gross proceeds of $ 4.25 million. The Company utilized a portion of
the proceeds, net of underwriting discounts of approximately $ 3.91 million from the October 2021Offering to fund certain obligations
under the Credit Agreement. (See Note 4)
On
December 6, 2021, we completed an offering for net proceeds of $ 16.0 million. As part of this offering, we issued 8,246,430 units
consisting of shares of the Company’s common stock and warrant to purchase shares of the Company’s common stock and 8,328,570 prefunded
warrants. The warrant issued as part of the units had an exercise price of $ 1.15 and the prefunded warrants had an exercise price
of $ 0.001 .
Risks
and Uncertainties
The
Company has a limited operating history and is in the very early stages of generating revenue from intended operations. The Company’s
business and operations are sensitive to general business and economic conditions in the U.S. and worldwide along with local, state,
and federal governmental policy decisions. A host of factors beyond the Company’s control could cause fluctuations in these conditions.
Adverse conditions may include: changes in the biotechnology regulatory environment, technological advances that render our technologies
obsolete, availability of resources for clinical trials, acceptance of technologies into the medical community, and competition from
larger, more well-funded companies. These adverse conditions could affect the Company’s financial condition and the results of
its operations.
On
January 30, 2020, the World Health Organization declared the COVID-19 novel coronavirus outbreak a “Public Health Emergency of
International Concern” and on March 10, 2020, declared it to be a pandemic. Actions taken around the world to help mitigate the
spread of the coronavirus include restrictions on travel, and quarantines in certain areas, and forced closures for certain types of
public places and businesses. The COVID-19 coronavirus and actions taken to mitigate it have had and are expected to continue to have
an adverse impact on the economies and financial markets of many countries, including the geographical area in which the Company operates.
While it is unknown how long these conditions will last and what the financial impact will be to the Company, it is reasonably possible
that future capital raising efforts and additional development of our technologies may be negatively affected.
6
NOTE
2 – GOING CONCERN ANALYSIS
Management
Plans
The
Company was incorporated on September 28, 2017 and has not generated significant revenues to date. During the three months ended March
31, 2022, the Company had a net loss of $ 6,059,141 and negative cash flow from operating activities of $ 5,199,304 . As of March 31,
2022 the Company’s cash balance was $ 2,115,206 . The Company has $ 67.3 million of remaining availability, subject to regulatory
requirements, to raise future funds pursuant to an effective shelf registration statement filed with the SEC on Form S-3 declared effective
on July 13, 2021. However, factors such as stock price, volatility, trading volume, market conditions, demand and regulatory requirements
may adversely affect the Company’s ability to raise capital in an efficient manner.
Because
of these factors, the Company believes that this creates substantial doubt with the Company’s ability to continue as a going concern.
The condensed financial statements included in
this report do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or
the amounts and classification of liabilities that may result from the matters discussed herein. The Company’s ability to continue
as a going concern is dependent upon the ability to complete clinical studies and implement the business plan, generate sufficient revenues
and to control operating expenses. In addition, the Company is consistently focused on raising capital, strategic acquisitions and alliances,
and other initiatives to strengthen the Company.
NOTE
3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The accompanying unaudited condensed financial statements have been
prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim
financial information and the rules and regulations of the Securities and Exchange Commission (“SEC”). In the opinion of the
Company’s management, the accompanying condensed financial statements reflect all adjustments, consisting of normal, recurring adjustments,
considered necessary for a fair presentation of the results for the interim periods ended March 31, 2022 and March 31, 2021. Although
management believes that the disclosures in these unaudited condensed financial statements are adequate to make the information presented
not misleading, certain information and footnote disclosures normally included in condensed financial statements that have been prepared
in accordance U.S. GAAP have been omitted pursuant to the rules and regulations of the SEC.
The accompanying unaudited condensed financial
statements should be read in conjunction with the Company’s financial statements and notes related thereto included in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 31, 2022. The interim results for the three
months ended March 31, 2022 are not necessarily indicative of the results to be expected for the year ended December 31, 2022 or for any
future interim periods.
Use
of Estimates
The preparation of condensed financial statements
in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of revenue
and expense during the reporting period. Actual results could differ from those estimates. Significant estimates underlying the condensed
financial statements include the fair value of stock options and warrants.
Fair
Value Measurements and Fair Value of Financial Instruments
The
Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic
820, Fair Value Measurements. ASC Topic 820 clarifies the definition of fair value, prescribes methods for measuring fair value, and
establishes a fair value hierarchy to classify the inputs used in measuring fair value as follows:
Level
1 -
Inputs
are unadjusted quoted prices in active markets for identical assets or liabilities available at the measurement date.
Level
2 -
Inputs
are unadjusted quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets
and liabilities in markets that are not active, inputs other than quoted prices that are observable, and inputs derived from or corroborated
by observable market data.
Level
3 -
Inputs
are unobservable inputs which reflect the reporting entity’s own assumptions on what assumptions the market participants would
use in pricing the asset or liability based on the best available information.
7
The
Company did not identify any assets or liabilities that are required to be presented on the balance sheets at fair value in accordance
with ASC Topic 820.
Due
to the short-term nature of all financial assets and liabilities, their carrying value approximates their fair value as of the balance
sheet dates.
Concentrations
of Credit Risk
The
Company maintains its cash accounts at financial institutions which are insured by the Federal Deposit Insurance Corporation. At times,
the Company may have deposits in excess of federally insured limits.
Cash
and Cash Equivalents
Cash
and cash equivalents include short-term, liquid investments.
Inventory
Inventory
consists of laboratory materials and supplies used in laboratory analysis. We capitalize inventory when purchased. Inventory is valued
at the lower of cost or net realizable value on a first-in, first-out basis. We periodically perform obsolescence assessments and write
off any inventory that is no longer usable.
Fixed
Assets
Fixed
assets are stated at cost less accumulated depreciation. Cost includes expenditures for furniture, office equipment, laboratory equipment,
and other assets. Maintenance and repairs are charged to expense as incurred. When assets are sold, retired, or otherwise disposed of,
the cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is reflected in operations. The costs
of fixed assets are depreciated using the straight-line method over the estimated useful lives or lease life of the related assets.
Intangible
Assets
Intangible
assets are stated at cost less accumulated amortization. For intangible assets that have finite lives, the assets are amortized using
the straight-line method over the estimated useful lives of the related assets. For intangible assets with indefinite lives, the assets
are tested periodically for impairment.
Accounts
Receivable and Allowance for Doubtful Accounts
Accounts
receivable are stated at the amount management expects to collect from outstanding balances. The Company generally does not require collateral
to support customer receivables. The Company determines if receivables are past due based on days outstanding, and amounts are written
off when determined to be uncollectible by management. As of March 31, 2022 and 2021, there was no allowance for doubtful accounts deemed
necessary.
Revenue
Recognition
In
accordance with ASC 606 (Revenue From Contracts with Customers), revenue is recognized when a customer obtains control of promised services.
The amount of revenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for these
services. To achieve this core principle, the Company applies the following five steps:
1) Identify the contract with a customer
2)
Identify the performance obligations in the contract
3)
Determine the transaction price
4)
Allocate the transaction price to performance obligations in the contract
5)
Recognize revenue when or as the Company satisfies a performance obligation
8
Revenues
reported from services provided by the AditxtScore™ division are recognized when the AditxtScore™ report is delivered to
the customer. The services performed include the analysis of specimens received in Aditxt’s CLIA laboratory and the generation
of results which are then delivered upon completion.
Fees
per test in the client payer channel are determined based on contractual arrangements with our customers. Generally, client revenues
are recorded based on the number of AditxtScore™ reports delivered at the contractual rate per test .
Leases
Under
Topic 842 (Leases), operating lease expense is generally recognized evenly over the term of the lease. The Company has operating leases
consisting of office space, laboratory space, and lab equipment.
Leases
with an initial term of twelve months or less are not recorded on the balance sheet. We combine the lease and non-lease components in
determining the lease liabilities and right of use (“ROU”) assets.
Stock-Based
Compensation
The
Company accounts for stock-based compensation costs under the provisions of ASC 718, Compensation—Stock Compensation, which requires
the measurement and recognition of compensation expense related to the fair value of stock-based compensation awards that are ultimately
expected to vest. Stock-based compensation expense recognized includes the compensation cost for all stock-based payments granted to
employees, officers, and directors based on the grant date fair value estimated in accordance with the provisions of ASC 718. ASC 718
is also applied to awards modified, repurchased, or cancelled during the periods reported. Stock-based compensation is recognized as
expense over the employee’s requisite vesting period and over the nonemployee’s period of providing goods or services.
Patents
The
Company incurs fees from patent licenses, which are expensed as incurred. During the three months ended March 31, 2022 and March 31,
2021, the Company incurred patent licensing fees for the patents of $ 225,013 and $ 69,360 , respectively.
Research
and Development
We incur research and development costs during the
process of researching and developing our technologies and future offerings. We expense these costs as incurred unless such costs qualify
for capitalization under applicable guidance. During the three months ended March 31, 2022 and March 31, 2021, the Company incurred research
and development costs of $ 1,428,382 and $ 935,952 , respectively.
Basic
and Diluted Net Loss per Common Share
Basic
loss per common share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding for each
period. Diluted loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding
plus the dilutive effect of shares issuable through the common stock equivalents. The weighted-average number of common shares outstanding
excludes common stock equivalents because their inclusion would be anti-dilutive. As of March 31, 2022, 2,235,466 stock options, 1,028,650
unvested restricted stock units, and 30,012,614 warrants were excluded from dilutive earnings per share as their effects
were anti-dilutive. As of March 31, 2021, 2,143,000 stock options and 5,463,715 warrants were excluded from dilutive
earnings per share as their effects were anti-dilutive.
Recent
Accounting Pronouncements
The FASB issues ASUs to amend the authoritative
literature in ASC. There have been several ASUs to date, including those above, that amend the original text of ASC. Management believes
that those issued to date either (i) provide supplemental guidance, (ii) are technical corrections, (iii) are not applicable to us or
(iv) are not expected to have a significant impact on our condensed financial statements.
9
NOTE
4 – NOTE RECEIVABLE
Cellvera
Global Note Receivable
On
August 25, 2021, the Company entered into a letter of intent (“the LOI”) to acquire AiPharma Global Holdings LLC, a Delaware
limited liability company, which changed its name to Cellvera Global Holdings LLC (“Cellvera Global”) which is commercializing
COVID-19 antiviral oral therapy. Key terms of the proposed transaction as stated in the Letter of Intent included: the completion of
a proposed $ 6.5 million secured loan from the Company to Cellvera Global by August 31, 2021, as well as the issuance of such number
of shares of the Company’s common stock that yields 50 % of the number of the Company’s outstanding shares post-closing
of the transaction. The acquisition is subject to the satisfaction of numerous conditions, including satisfactory due diligence, the
negotiation and execution of definitive agreements and other closing conditions, including board and shareholder approval and approval
by Nasdaq of the listing of shares proposed to be issued in the transaction. The Company and Cellvera Global agreed to an exclusivity
period until September 30, 2021 (the “Exclusivity Period”), with a view to settling the definitive agreement. On September
30, 2021, the parties entered into a letter agreement pursuant to which they agreed to extend the Exclusivity Period until October 4,
2021.
On
December 28, 2021, we entered into a Share Exchange Agreement with Cellvera Global f/k/a AiPharma Global, pursuant to which we (i)
will acquire 9.5% of the issued and outstanding equity interests in Cellvera Global in exchange for the issuance of 4,816,193 shares
of our common stock of Aditxt and a cash payment of $250,000, at an initial closing upon the satisfaction or waiver of certain conditions
to closing; and (ii) acquire the remaining 90.5% of the issued and outstanding equity interests in Cellvera Global in exchange for the
issuance of 39,927,974 shares of our common stock and a cash payment of $250,000 at a secondary closing upon the satisfaction or waiver
of certain conditions to closing. Additionally, we may elect to raise additional capital due to market conditions or strategic considerations.
In connection with the contemplated acquisition
with Cellvera Global, the Company entered into a secured credit agreement dated August 27, 2021 (the “Credit Agreement”)
with Cellvera Global and certain affiliated entities (collectively, the “Borrower”), pursuant to which the Company made a
secured loan to Cellvera Global in the principal amount of $ 6.5 million (the “Loan”). The Loan was funded on August 31,
2021, following the closing of the Company’s August 2021 Offering. The Loan bears interest at a rate of 8 % per annum and matured
on November 30, 2021. The Loan is secured by certain accounts receivable and other assets of Cellvera Global and certain of its affiliates.
The Credit Agreement also contains certain covenants that prohibit Cellvera Global from incurring additional indebtedness, incurring liens
or making any dispositions of its property.
On
October 18, 2021, the Company entered into the first amendment to the Credit Agreement with Cellvera Global and certain affiliated
entities (the “Credit Agreement Amendment”), pursuant to which the Company agreed to increase the amount which Cellvera Global
was permitted to borrow under the Credit Agreement by $8.5 million to an aggregate of $15.0 million, of which $6.5 million was outstanding
prior to entering the Credit Agreement Amendment. The Company agreed to fund such additional borrowings, as requested by Cellvera Global,
by advancing 70% of any amounts received by the Company from the exercise of existing warrants or any other capital raises, including
the October Offering. As of December 31, 2021 an additional $ 8.0 million was advanced under the Credit Agreement for a total
of $ 14.5 million.
The
Credit Agreement was amended on multiple occasions, for which the final amendment was signed on December 31, 2021, extending the Loan’s
maturity date to January 31, 2022.
The
Company determined that Cellvera Global may not have the ability to repay the note receivable. Accordingly, the Company recognized a
full impairment of $ 14.5 million as of December 31, 2021.
Forbearance
Agreement:
On
January 31, 2022, the Company’s $ 14.5 million loan to Cellvera Global became fully due and payable under the Credit Agreement.
On February 14, 2022, the Company entered into a Forbearance Agreement and Seventh Amendment to Credit Agreement (the “Forbearance
Agreement”) with Cellvera Global.
Pursuant to the Forbearance Agreement, the Company
agreed to forbear from exercising its rights and remedies against Cellvera Global and certain affiliated guarantor parties until the earlier
of (i) June 30, 2022 or (ii) the date of occurrence of any event of default under the Forbearance Agreement (the “Forbearance Period”).
Given that the parties continue to conduct due diligence in connection with the Share Exchange Agreement the Company and Cellvera Global
also agreed that should the initial closing occur under the Share Exchange Agreement, the existing event of default will be waived. Under
the Forbearance Agreement, the Company and Cellvera Global also agreed to certain amendments to the Credit Agreement, including, but not
limited to: (i) the delivery by the Borrower of certain financial statements and forecasts, and (ii) certain regularly scheduled payments
to be made by Cellvera Global to the Company during the Forbearance Period. As of the date these financial statements were available to
be issued; the regularly scheduled payments under the Forbearance Agreement were not made, and the note receivable remains fully impaired.
10
Target
Company Note Receivable
On
December 10, 2021, the Company entered into a secured credit agreement dated December 10, 2021 (the “Target Company Credit Agreement”)
and signed on December 10, 2021 with the Target Company, pursuant to which the Company made a secured loan to the Target Company in the
principal amount of $500,000 (the “Target Company Loan”) and agreed to make additional secured loans, as requested by the
Target Company and approved by the Company, in an amount not to exceed $4.5 million. The Target Company Loan bears interest at a rate
of 8% per annum and mature on December 8, 2022, provided, that the Letter of Intent currently contemplates that the Target Company Loan
will be forgivable upon the closing of the acquisition contemplated by the letter of intent. The Target Company Credit Agreement also
contains certain covenants that prohibit the Target Company from incurring additional indebtedness, entering into any fundamental transactions,
issuing any equity interests subject to certain limited exceptions, or making any dispositions of its property. In connection with the
Target Company Credit Agreement, the Company entered into a Security Agreement with the Target Company, pursuant to which the Target
Company granted the Company a security interest in all of the Target Company’s assets as security for the Target Company Loan.
As
of March 31, 2022, the outstanding principal of the Target Company Loan is $ 500,000 and the accrued interest on the Loan is $ 16,425 .
NOTE
5 – FIXED ASSETS
The
Company’s fixed assets include the following on March 31, 2022:
Cost Basis
Accumulated
Depreciation
Net
Computers
$ 370,607
$ ( 105,150 )
$ 265,457
Lab Equipment
2,366,240
( 374,182 )
1,992,058
Office Furniture
56,656
( 3,951 )
52,705
Other Fixed Assets
8,605
( 578 )
8,027
Total Fixed Assets
$ 2,802,108
$ ( 483,861 )
$ 2,318,247
The
Company’s fixed assets include the following on December 31, 2021:
Cost Basis
Accumulated
Depreciation
Net
Computers
$ 312,489
$ ( 75,053 )
$ 237,436
Lab Equipment
2,240,252
( 306,688 )
1,933,564
Office Furniture
90,757
( 4,857 )
85,900
Other Fixed Assets
10,809
( 412 )
10,397
Total Fixed Assets
$ 2,654,307
$ ( 387,010 )
$ 2,267,297
Depreciation
expense was $ 96,852 and $ 66,243 , for the three months ended March 31, 2022 and 2021, respectively. None of the Company’s fixed
assets serve as collateral against any loans as of March 31, 2022 and December 31, 2021, other than those subject to the financed asset
liability.
NOTE
6 – INTANGIBLE ASSETS
The
Company’s intangible assets include the following on March 31, 2022:
Cost Basis
Accumulated
Amortization
Net
Proprietary Technology
$ 321,000
$ ( 133,750 )
$ 187,250
Total Intangible Assets
$ 321,000
$ ( 133,750 )
$ 187,250
The
Company’s intangible assets include the following on December 31, 2021:
Cost Basis
Accumulated
Amortization
Net
Proprietary Technology
$ 321,000
$ ( 107,000 )
$ 214,000
Total Intangible Assets
$ 321,000
$ ( 107,000 )
$ 214,000
Amortization
expense was $ 26,750 and $ 26,384 for the three months ended March 31, 2022 and 2021, respectively. None of the Company’s
intangible assets serve as collateral against any loans as of March 31, 2022, and December 31, 2021.
11
NOTE
7 – RELATED PARTY TRANSACTIONS
On
January 26, 2022, the Company granted 480,000 restricted stock units to an officer of the Company pursuant to the Company’s 2021
Equity Incentive Plan. The Company recognized $ 87,420 in stock-based compensation for the issuance of these vested and unvested restricted
stock units during the period ended March 31, 2022. (Note 9)
NOTE
8 – LEASES
Our
lease agreements generally do not provide an implicit borrowing rate; therefore, an internal incremental borrowing rate is determined
based on information available at lease commencement date for purposes of determining the present value of lease payments. We used the
incremental borrowing rate on March 31, 2022 and December 31, 2021 for all leases that commenced prior to that date. In determining this
rate, which is used to determine the present value of future lease payments, we estimate the rate of interest we would pay on a collateralized
basis, with similar payment terms as the lease and in a similar economic environment.
Lease
Costs
Three Months
Ended
March 31,
2022
Three Months
Ended
March 31,
2021
Components of total lease costs:
Operating lease expense
$ 322,495
$ 124,614
Total lease costs
$ 322,495
$ 124,614
Lease
Positions as of March 31, 2022 and December 31, 2021
ROU
lease assets and lease liabilities for our operating leases are recorded on the balance sheet as follows:
March 31,
2022
December 31,
2021
Assets
Right of use asset – long term
$ 3,883,781
$ 4,097,117
Total right of use asset
$ 3,883,781
$ 4,097,117
Liabilities
Operating lease liabilities – short term
$ 1,137,980
$ 1,145,126
Operating lease liabilities – long term
2,554,683
2,765,933
Total lease liability
$ 3,692,663
$ 3,911,059
Lease
Terms and Discount Rate
Weighted average remaining lease term (in years) – operating leases
2.30
Weighted average discount rate – operating leases
8.00 %
12
NOTE
9 – STOCKHOLDERS’ EQUITY
Common
Stock
On
May 24, 2021, the Company increased the number of authorized shares of the Company’s common stock, par value $ 0.001 per share,
from 27,000,000 to 100,000,000 (the “Authorized Shares Increase”) by filing a Certificate of Amendment
(the “Certificate of Amendment”) to its Amended and Restated Certificate of Incorporation with the Secretary of State of
the State of Delaware. In accordance with the General Corporation Law of the State of Delaware, the Authorized Shares Increase and the
Certificate of Amendment were approved by the stockholders of the Company at the Company’s Annual Meeting of Stockholders on May
19, 2021.
During the three months ended March 31, 2022,
the Company issued 9,000 shares of common stock and recognized expense of $ 3,719 in stock-based compensation for consulting
services. The Company also granted 582,200 Restricted Stock Units, of which 287,850 vested and resulted in the issuance
of shares. As a result, the Company recognized expense of $ 377,671 in stock-based compensation. The stock-based compensation for
shares issued or RSU’s granted during the period were valued based on the fair market value on the date of grant.
During
the three months ended March 31, 2021, the Company issued 18,000 shares of common stock and recognized expense of $ 51,240 in stock-based
compensation for consulting services. The Company also issued 1,163,556 shares of common stock for the exercise of warrants and received
$ 3,718,956 in cash proceeds. The Company granted 335,000 shares of restricted common stock for compensation and recognized expense of
$ 1,112,200 in stock-based compensation. The stock-based compensation for the period was valued based on the value of the shares based
on public information.
Preferred
Stock
The
Company is authorized to issue 3,000,000 shares of preferred stock, par value $ 0.001 per share. There were no shares of
preferred stock outstanding as of March 31, 2022 and December 31, 2021, respectively.
Stock-Based
Compensation
In
October 2017, our Board of Directors adopted the Aditx Therapeutics, Inc. 2017 Equity Incentive Plan (the “2017 Plan”). The
2017 Plan provides for the grant of equity awards to directors, employees, and consultants. The Company is authorized to issue up
to 2,500,000 shares of our common stock pursuant to awards granted under the 2017 Plan. The 2017 Plan is administered by our
Board of Directors, and expires ten years after adoption, unless terminated earlier by the Board of Directors.
On
February 24, 2021, our Board of Directors adopted the Aditx Therapeutics, Inc. 2021 Omnibus Equity Incentive Plan (the “2021 Plan”).
The 2021 Plan provides for grants of nonqualified stock options, incentive stock options, stock appreciation rights, restricted stock
and restricted stock units, and other stock-based awards (collectively, the “Awards”). Eligible recipients of Awards include
employees, directors or independent contractors of the Company or any affiliate of the Company. The Compensation Committee of the Board
of Directors (the “Committee”) will administer the 2021 Plan. A total of 3,000,000 shares of common stock, par
value $ 0.001 per share, of the Company may be issued pursuant to Awards granted under the 2021 Plan. The exercise price per share
for the shares to be issued pursuant to an exercise of a stock option will be no less than one hundred percent ( 100 %) of the Fair Market
Value (as defined in the 2021 Plan) of a share of Common Stock on the date of grant. The 2021 Plan was submitted and approved by the
Company’s stockholders at the 2021 annual meeting of stockholders, held on May 19, 2021.
During
the three months ended March 31, 2022 and 2021, the Company granted no new options.
The
following is an analysis of the stock option grant activity under the Plan:
Vested and Nonvested
Stock Options
Number
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Life
Outstanding December 31, 2021
2,235,466
$ 3.40
6.74
Granted
-
-
-
Exercised
-
-
-
Expired or forfeited
-
-
-
Outstanding March 31, 2022
2,235,466
$ 3.40
6.50
13
Nonvested Stock Options
Number
Weighted-
Average
Exercise
Price
Nonvested on December 31, 2020
453,125
$ 2.17
Granted
-
-
Vested
( 116,875 )
2.17
Forfeited
-
-
Nonvested on March 31, 2022
336,250
$ 2.18
The
Company recognized stock-based compensation expense related to options granted and vesting expense of $ 193,624 during the three
months ended March 31, 2022, of which $ 133,660 is included in general and administrative expenses and $ 59,964 is included in
research and development expenses in the accompanying statements of operations. The remaining value to be expensed is $ 777,456 with
a weighted average vesting term of 0.62 years as of March 31, 2022. The Company recognized stock-based compensation expense
related to options issued and vesting of $ 211,579 during the three months ended March 31, 2021, which is included in general and administrative
expenses in the accompanying statements of operations.
Warrants
During
the three months ended March 31, 2022 the Company granted no new warrants. During the three months ended March 31, 2021, the Company
granted 875,000 warrants.
For the three months ended March 31, 2022 there
were no new warrants granted, therefore no fair value was assigned. For the three months ended March 31, 2021, the fair value of each
warrant granted was estimated using the assumption ranges and/or factors in the Black-Scholes Model as follows:
Exercise price
$ 4.00
Expected dividend yield
0 %
Risk free interest rate
0.17 %- 0.42 %
Expected life in years
3.00 - 5.00
Expected volatility
154 %- 159 %
The
risk-free interest rate assumption for warrants granted is based upon observed interest rates on the United States Government Bond Equivalent
Yield appropriate for the expected term of warrants.
The
Company determined the expected volatility assumption for warrants granted using the historical volatility of comparable public companies’
common stock. The Company will continue to monitor peer companies and other relevant factors used to measure expected volatility for
future warrant grants, until such time that the Company’s common stock has enough market history to use historical volatility.
The
dividend yield assumption for warrants granted is based on the Company’s history and expectation of dividend payouts. The Company
has never declared nor paid any cash dividends on its common stock, and the Company does not anticipate paying any cash dividends in
the foreseeable future.
The
Company recognizes warrant forfeitures as they occur as there is insufficient historical data to accurately determine future forfeitures
rates.
A
summary of warrant issuances are as follows:
Vested and Nonvested
Warrants
Number
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Life
Outstanding December 31, 2021
30,069,964
$ 1.67
4.38
Granted
-
-
-
Exercised
-
-
-
Expired or forfeited
( 57,350 )
5.79
-
Outstanding March 31, 2022
30,012,614
$ 1.66
4.27
Nonvested Warrants
Number
Weighted-
Average
Exercise
Price
Nonvested on December 31, 2021
4,628,334
$ 1.51
Granted
-
-
Vested
( 4,598,334 )
1.50
Forfeited
-
Nonvested on March 31, 2022
30,000
$ 1.92
14
The
Company recognized stock-based compensation expense related to warrants granted and vesting expense of $ 26,262 and $ 89,883 during
the three months ended March 31, 2022 and March 31, 2021, respectively, which is included in general and administrative in the accompanying
Statements of Operations. The remaining value to be expensed is $ 78,787 with a weighted average vesting term of 0.50 years
as of March 31, 2022.
Restricted
Stock Units
A
summary of Restricted Stock Units (“RSUs”) issuances are as follows:
Nonvested RSUs
Number
Weighted
Average
Price
Nonvested December 31, 2021
778,250
$ 1.92
Granted
582,200
0.45
Vested
( 287,850 )
1.00
Forfeited
( 43,950 )
2.00
Nonvested March 31, 2022
1,028,650
$ 1.35
The
Company recognized stock-based compensation expense related to RSUs granted and vesting expense of $ 377,671 and zero during
the three months ended March 31, 2022 and March 31, 2021, respectively, of which, $ 288,346 is included in general and administrative
and $ 89,325 is included in research and development in the accompanying Statements of Operations. The remaining value to be expensed
is $ 1,197,321 with a weighted average vesting term of 0.97 years as of March 31, 2022.
During
the three months ended March 31, 2022, the Company granted a total of 582,200 RSUs. As of March 31, 2022, 287,850 of these
RSUs vested and the Company issued 287,850 shares of common stock for the 287,850 vested RSUs.
NOTE
10 – INCOME TAXES
The
Company has incurred losses since inception. During the nine months ended March 31, 2022, the Company did not provide any provision for
income taxes as the Company incurred losses during such period. The Company accounts for income taxes using the asset and liability method
in accordance with ASC 740, “Accounting for Income Taxes”. The asset and liability method provides that deferred tax assets
and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and
tax bases of assets and liabilities and for operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured
using the currently enacted tax rates and laws that will be in effect when the differences are expected to reverse. In assessing the
need for a valuation allowance, the Company has considered both positive and negative evidence related to the likelihood of realization
of deferred tax assets using a “more likely than not” standard. In making such assessment, more weight was given to evidence
that could be objectively verified, including recent cumulative losses. Based on the Company’s review of this evidence, the Company
has recorded a full valuation allowance for its net deferred tax assets as of March 31, 2022.
As
of March 31, 2022, the Company did not have any amounts recorded pertaining to uncertain tax positions.
NOTE
11 – SUBSEQUENT EVENTS
Cellvera Global:
On April 4, 2022, the Company and Cellvera Global
entered into a Forbearance Agreement and Eighth Amendment to the Credit Agreement (the “April Forbearance Agreement”) pursuant
to which among other things (i) the Company agreed to extend the forbearance period until the earlier of March 31, 2023 or the date of
occurrence of any event of default under the April Forbearance Agreement, (ii) Cellvera Global shall be permitted to factor certain receivables,
and (iii) certain conforming changes were made relating to the Revenue Sharing Agreement (as defined below). In connection with the Forbearance
Agreement, the Company entered into a series of security agreements with Cellvera Global (the “Security Agreements”) and certain
affiliated entities pursuant to which Cellvera Global enhanced the Company’s security interest in connection with the Credit Agreement.
In addition, and as a condition to entering into the April Forbearance Agreement, the Company required that Cellvera Global enter into
a Revenue Sharing Agreement (the “Revenue Sharing Agreement”), pursuant to which, among other things, Cellvera Global agreed
to pay the Company a certain portion of its revenues up to the aggregate amount of $ 30 million.
Concurrently with the execution of the April Forbearance Agreement
and the Revenue Sharing Agreement, the Company and AiPharma Group, Ltd. entered into an Amendment to the Share Exchange Agreement (the
“Share Exchange Amendment”) which amended the Share Exchange Agreement to, among other things: (i) modify the financial statements
required to be delivered by AiPharma Group, Ltd. at the initial closing to include the unaudited financial statements for the three months
ended March 31, 2022 and 2021, (ii) permit the Company to amend its Certificate of Incorporation without the consent of AiPharma Group,
Ltd. in order to effect a reverse stock split of the Company’s common stock, if necessary, in order to maintain its listing on
the Nasdaq Capital Market, and (iii) make certain other conforming changes related to the March Forbearance Agreement and Revenue Sharing
Agreement.
Common stock offering:
On May 14, 2022, the Company entered into a securities
purchase agreement (the “May 2022 Purchase Agreement”) with an accredited investor, pursuant to which the Company agreed to
issue and sell an aggregate of 8,333,334 shares of the Company’s common stock (the “Shares”) at a per share purchase
price of $ 0.30 for gross proceeds to the Company of $ 2.5 million. For each Share purchased, the investor also received a warrant to purchase
one share of the Company’s common stock (the “Warrants”). The Warrants have an exercise price of $ 0.33 per share and
are exercisable for a term of five years commencing six months from the date of closing. Pursuant to the May 2022 Purchase Agreement,
the Company agreed to file a registration statement registering the Shares and the shares of common stock underlying the Warrants within
sixty days after the closing. The closing is expected to occur on or about May 20, 2022.
15
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion
and analysis of our financial condition and results of operations should be read together with the unaudited condensed financial statements
and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and the audited financial statements and related notes for
the year ended December 31, 2021 included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC.
In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties,
and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of certain
factors. We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this Quarterly Report
on Form 10-Q, including those factors set forth in the section entitled “Cautionary Note Regarding Forward-Looking Statements and
Industry Data” and in the section entitled “Risk Factors” in Part II, Item 1A.
Overview
We
are a biotech innovation company with a mission of prolonging life and enhancing its quality by improving the health of the immune system.
We are developing biotechnologies specifically focused on improving the health of the immune system through immune reprogramming and
monitoring. Our immune reprogramming technologies are currently at the pre-clinical stage and are designed to retrain the immune system
to induce tolerance with an objective of addressing rejection of transplanted organs, autoimmune diseases, and allergies. Our immune
monitoring technologies are designed to provide a personalized comprehensive profile of the immune system and we plan to utilize them
in our upcoming reprogramming clinical trials to monitor subjects’ immune response before, during and after drug administration.
Immune
Reprogramming
The
discovery of immunosuppressive (anti-rejection and monoclonal) drugs over 40 years ago has made possible life-saving organ transplantation
procedures and blocking of unwanted immune responses in autoimmune diseases. However, immune suppression leads to significant undesirable
side effects, such as increased susceptibility to life-threatening infections and cancers, because it indiscriminately and broadly suppresses
immune function throughout the body. While the use of these drugs has been justifiable because they prevent or delay organ rejection,
their use for treatment of autoimmune diseases and allergies may not be acceptable because of the aforementioned side effects. Furthermore,
transplanted organs often ultimately fail despite the use of immune suppression, and about 40% of transplanted organs survive no more
than 5 years.
New,
focused therapeutic approaches are needed that modulate only the small portion of immune cells that are involved in rejection of the
transplanted organ, as this approach can be safer for patients than indiscriminate immune suppression. Such approaches are referred to
as immune tolerance, and when therapeutically induced, may be safer for patients and potentially allow long-term survival of transplanted
tissues and organs.
In
the late 1990s, academic research on these approaches was conducted at the Transplant Center in Loma Linda University (“LLU”)
in connection with a project that secured initial grant funding from the U.S. Department of Defense. The focus of that project was for
skin grafting for burn victims. Twenty years of research at LLU and an affiliated incubator led to a series of discoveries that have
been translated into a large patent portfolio of therapeutic approaches that may be applied to the modulation of the immune system to
induce tolerance to self and transplanted organs.
16
We
have an exclusive worldwide license for commercializing this nucleic acid-based technology (which is currently at the pre-clinical stage),
named Apoptotic DNA Immunotherapy™ (ADi™) from LLU, which utilizes a novel approach that mimics the way the body naturally
induces tolerance to our own tissues (“therapeutically induced immune tolerance”). While immune suppression requires continuous
administration to prevent rejection of a transplanted organ, induction of tolerance has the potential to retrain the immune system to
accept the organ for longer periods of time. Thus, ADi™ may allow patients to live with transplanted organs with significantly
reduced immune suppression. ADi™ is a technology platform which we believe can be engineered to address a wide variety of indications.
We
are developing ADi™ products for organ transplantation including skin grafting, autoimmune diseases, and allergies, with the initial
focus on skin allografts and psoriasis, as we believe these indications will be most efficient in providing safety and efficacy data
in clinical trials. To submit a Biologics License Application (“BLA”) for a biopharmaceutical product, clinical safety and
efficacy must be demonstrated in a series of clinical studies conducted with human subjects. For products in our class of drugs, the
first-in-human trials will be a combination of Phase I (safety/tolerability) and Phase II (efficacy) in affected subjects. To obtain
approval to initiate the Phase I/IIa studies, an Investigational New Drug Application will be submitted to compile non-clinical efficacy
data as well as manufacturing and pre-clinical safety/toxicology data. To date, we have conducted non-clinical studies in a stringent
model of skin transplantation using genetically mismatched donor and recipient animals demonstrating a 3-fold increase in the survival
of the skin graft in animals that were tolerized with ADi™ compared to animals that receive immune suppression alone. Prolongation
of graft life was observed despite discontinuation of immune suppression after the first 5 weeks. Additionally, in an induced non-clinical
model for psoriasis, ADi™ treatment resulted in a 69% reduction in skin thickness and a 38% decrease in skin flaking (two clinical
parameters for assessment of psoriasis skin lesions). The Phase I/IIa studies in psoriasis will evaluate the safety/tolerability of ADi™
in patients diagnosed with psoriasis. Since the drug will be administered in subjects diagnosed with psoriasis, effectiveness of the
drug to improve psoriatic lesions will also be evaluated. In another Phase I/IIa study, patients requiring skin allografts will receive
weekly intra-dermal injections of ADi™ in combination with standard immune suppression to assess safety/tolerability and possibility
of reducing levels of immunosuppressive drugs as well as prolongation of graft life. Later phase trials are planned after successful
completion of these studies in preparation for submission for a BLA to regulatory agencies.
Immune
Monitoring
We
believe that understanding the status of an individual’s immune system is key to developing and administering immunotherapies such
as ADI™. We have secured an exclusive worldwide license for commercializing a technology platform named AditxtScore™, which
provides a personalized comprehensive profile of the immune system. It is intended to be informative for individual immune responses
to viruses, bacterial antigens, peptides, drugs, bone marrow and solid organ transplants, and cancer. It has broad applicability to many
other agents of clinical interest impacting the immune system, including those not yet identified such as future infectious agents.
AditxtScore™
is being designed to allow individuals to understand, manage and monitor their immune profiles in order to be informed about attacks
on or by their immune system. We believe AditxtScore™ can also assist the medical community in anticipating possible immune responses
and reactions to viruses, bacteria, allergens and transplanted organs. It can be useful in anticipating attacks on the body by having
the ability to determine its potential response and for developing a plan to deal with an undesirable reaction by the immune system.
Its advantages include the ability to provide a simple, rapid, accurate, high throughput, single platform assay that can be multiplexed
to determine the immune status with respect to several factors simultaneously, in 3-16 hours, as well as detect antigen and antibody
in a single test (i.e. infectious, recovered, immune). In addition, it can determine and differentiate between various types of cellular
and humoral immune responses (T and B cells). It also provides for simultaneous monitoring of cell activation and levels of cytokine
release (i.e., cytokine storms).
17
We
plan to utilize AditxtScore™ in our upcoming clinical trials to monitor subjects’ immune response before, during and after
ADI™ drug administration. We are also evaluating plans to obtain FDA approval for AditxtScore™’s use as a clinical
assay and seeking to secure manufacturing, marketing and distribution partnerships for application in the Infectious Diseases market,
by end of 2020. To obtain FDA approval to use AditxtScore™ as a clinical assay, we plan to conduct validation studies comparing
AditxtScore™ to other immunological tests to demonstrate reproducibility of data and to demonstrate the sensitivity of the assays
for use in different indications (e.g., detection of antigens present in infectious agents or antibodies against infectious agents).
We believe that these data will show AditxtScore™’s ability to multiplex in two ways using a single assay: (i) evaluating
the immune response to multiple antigens (from different infectious agents) and (ii) measuring quantities of multiple cytokines. Furthermore,
we believe that the additional validation studies will demonstrate AditxtScore™’s ability to measure the presence of several
antibody isotypes against several antigens in a single reaction. Our plan is to submit a 510(K) application to the FDA after successful
completion of these studies. We have engaged consultants for our communications and submissions to the FDA. Beyond 2021, we plan to develop
AditxtScore™ for applications in additional markets such as Organ Rejection, Allergies, Drug/Vaccine Response, and Disease Susceptibility.
The
initial application of the platform will be AditxtScore™ for COVID-19 which has been designed to provide a more complete assessment
of an individual’s infection and immunity status with respect to the SARS-CoV-2 virus. Infection status will be determined by evaluating
the presence or absence of the virus, and immunity status by measuring levels of antibodies against viral antigens and their ability
to neutralize the virus. We will soon be expanding the panel to measure other components of the immune response such as cellular immunity.
In early 2021, we established our AditxtScore™ Immune Monitoring Center in Richmond, Virginia (the “Center”). The Center
operates as a Clinical Laboratory Improvement Amendments (CLIA) certified facility for the processing of our AditxtScore™ for COVID-19
Lab Developed Test (LDT) for our prospective channel partners, including labs and hospitals.
License
Agreement with Loma Linda University
On
March 8, 2018, we entered into an Assignment Agreement (the “Assignment Agreement”) with Sekris Biomedical, Inc. (“Sekris”).
Sekris was a party to a license agreement with LLU, entered and made effective on May 25, 2011, and amended on June 24, 2011, July 16,
2012 and December 27, 2012 (the “Original Agreement,” and together with the Assignment Agreement, the “Sekris Agreements”).
Pursuant to the Assignment Agreement, Sekris transferred and assigned all of its rights, obligations and liabilities under the Original
Agreement, of whatever kind or nature, to us. In exchange, on March 8, 2018, we issued a warrant to Sekris to purchase up to 500,000
shares of our common stock (the “Sekris Warrant”). The warrant was immediately exercisable and has an exercise price of $4.00
per share. The expiration date of the warrant is March 8, 2023. On March 15, 2018, as amended on July 1, 2020, we entered into a LLU
License Agreement directly with Loma Linda University, which amends and restates the Sekris Agreements.
Pursuant
to the LLU License Agreement, we obtained the exclusive royalty-bearing worldwide license in and to all intellectual property, including
patents, technical information, trade secrets, proprietary rights, technology, know-how, data, formulas, drawings, and specifications,
owned or controlled by LLU and/or any of its affiliates (the “LLU Patent and Technology Rights”) and related to therapy for
immune-mediated inflammatory diseases (the ADi™ technology). In consideration for the LLU License Agreement, we issued 25,000 shares
of common stock to LLU.
Pursuant
to the LLU License Agreement, we are required to pay an annual license fee to LLU. Also, we paid LLU $455,000 in July 2020 for
outstanding milestone payments and license fees. We are also required to pay to LLU milestone payments in connection with certain
development milestones. Specifically, we are required to make the following milestone payments to LLU: $175,000 on March 31, 2022;
$100,000 on March 31, 2024; $500,000 on March 31, 2026; and $500,000 on March 31, 2027. In lieu of the $175,000 milestone payment
due on March 31, 2022, the Company paid LLU an extension fee of $100,000. Upon payment of this extension fee, an additional year
will be added for the March 31, 2022 milestone. Additionally, as consideration for prior expenses incurred by LLU to prosecute,
maintain and defend the LLU Patent and Technology Rights, we made the following payments to LLU: $70,000 at the end of December
2018, and a final payment of $60,000 at the end of March 2019. We are required to defend the LLU Patent and Technology Rights during
the term of the LLU License Agreement. Additionally, we will owe royalty payments of (i) 1.5% of Net Product Sales (as such terms
are defined under the LLU License Agreement) and Net Service Sales on any Licensed Products (defined as any finished pharmaceutical
products which utilizes the LLU Patent and Technology Rights in its development, manufacture or supply), and (ii) 0.75% of Net
Product Sales and Net Service Sales for Licensed Products and Licensed Services (as such terms are defined under the LLU License
Agreement) not covered by a valid patent claim for technology rights and know-how for a three (3) year period beyond the expiration
of all valid patent claims. We also are required to produce a written progress report to LLU, discussing our development and
commercialization efforts, within 45 days following the end of each year. All intellectual property rights in and to LLU Patent and
Technology Rights shall remain with LLU (other than improvements developed by or on our behalf).
18
The
LLU License Agreement shall terminate on the last day that a patent granted to us by LLU is valid and enforceable or the day that
the last patent application licensed to us is abandoned. The LLU License Agreement may be terminated by mutual agreement or by us
upon 90 days written notice to LLU. LLU may terminate the LLU License Agreement in the event of (i) non-payments or late payments of
royalty, milestone and license maintenance fees not cured within 90 days after delivery of written notice by LLU, (ii) a breach of
any non-payment provision (including the provision that requires us to meet certain deadlines for milestone events (each, a
“Milestone Deadline”)) not cured within 90 days after delivery of written notice by LLU and (iii) LLU delivers notice to
us of three or more actual breaches of the LLU License Agreement by us in any 12-month period. Additional Milestone Deadlines
include: (i) the requirement to have regulatory approval of an IND application to initiate first-in-human clinical trials on or
before March 31, 2022, which has been extended to March 31, 2023 due to payment of a $100,000 extension fee paid in March 2022, (ii)
the completion of first-in-human (phase I/II) clinical trials by March 31, 2024, (iii) the completion of Phase III clinical trials
by March 31, 2026 and (iv) biologic licensing approval by the FDA by March 31, 2027.
License
Agreement with Leland Stanford Junior University (“Stanford”)
On
February 3, 2020, we entered into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford regarding
a patent concerning a method for detection and measurement of specific cellular responses. Pursuant to the February 2020 License Agreement,
we received an exclusive worldwide license to Stanford’s patent regarding use, import, offer, and sale of Licensed Products (as
defined in the agreement). The license to the patented technology is exclusive, including the right to sublicense, beginning on the effective
date of the agreement, and ending when the patent expires. Under the exclusivity agreement, we acknowledged that Stanford had already
granted a non-exclusive license in the Nonexclusive Field of Use, under the Licensed Patents in the Licensed Field of Use in the Licensed
Territory (as those terms are defined in the February 2020 License Agreement”). However, Stanford agreed to not grant further licenses
under the Licensed Patents in the Licensed Field of Use in the Licensed Territory. On December 29, 2021, we entered into an amendment
to the February 2020 License Agreement which extended our exclusive right to license the technology deployed in AditxtScore TM
and securing worldwide exclusivity in all fields of use of the licensed technology.
We
were obligated to pay and paid a fee of $25,000 to Stanford within 60 days of February 3, 2020. We also issued 18,750 shares of the Company’s
common stock to Stanford. An annual licensing maintenance fee is payable by us on the first anniversary of the February 2020 License
Agreement in the amount of $40,000 for 2021 through 2024 and $60,000 starting in 2025 until the license expires upon the expiration of
the patent. The Company is required to pay and has paid $25,000 for the issuances of certain patents. The Company will pay milestone
fees of $50,000 on the first commercial sales of a licensed product and $25,000 at the beginning of any clinical study for regulatory
clearance of an in vitro diagnostic product developed and a potential licensed product. The Company paid a milestone fee for a clinical
study for regulatory clearance of an in vitro diagnostic product developed and a potential licensed product of $25,000 in March of 2022.
We are also required to: (i) provide a listing of the management team or a schedule for the recruitment of key management positions by
March 31, 2020 (which has been completed), (ii) provide a business plan covering projected product development, markets and sales forecasts,
manufacturing and operations, and financial forecasts until at least $10,000,000 in revenue by June 30, 2020 (which has been completed),
(iii) conduct validation studies by September 30, 2020 (which has been completed), (iv) hold a pre-submission meeting with the FDA by
September 30, 2020 (which has been completed), (iv) submit a 510(k) application to the FDA, Emergency Use Authorization (“EUA”),
or a Laboratory Developed Test (“LDT”) by March 31, 2021 (which has been completed), (vi) develop a prototype assay for human
profiling by December 31, 2021 (which has been completed), (vii) execute at least one partnership for use of the technology for transplant,
autoimmunity, or infectious disease purposes by March 31, 2022 and (viii) will provide further development and commercialization
milestones for specific fields of use in writing by December 31, 2022.
In
addition to the annual license maintenance fees outlined above, we will pay Stanford royalties on Net Sales (as such term is defined
in the February 2020 License Agreement) during the of the term of the agreement as follows: 4% when Net Sales are below or equal to $5
million annually or 6% when Net Sales are above $5 million annually. The February 2020 License Agreement may be terminated upon our election
on at least 30 days advance notice to Stanford, or by Stanford if we: (i) are delinquent on any report or payment; (ii) are not diligently
developing and commercializing Licensed Product; (iii) miss certain performance milestones; (iv) are in breach of any provision of the
February 2020 License Agreement; or (v) provide any false report to Stanford. Should any events in the preceding sentence occur, we have
a thirty (30) day cure period to remedy such violation.
19
Our
Team
We
have assembled a team of experts from a variety of scientific fields and commercial backgrounds, with many years of collective experience
that ranges from founding startup biotech companies, to developing and marketing biopharmaceutical products, to designing clinical trials,
and to management of private and public companies.
Going
Concern
We
were incorporated on September 28, 2017 and have not generated significant revenues to date. During the three months ended March 31,
2022 we had a net loss of $6,059,141 and cash of $2,115,206. The Company will require significant additional capital to operate in the
normal course of business and fund clinical studies in the long-term. As a result of the January 2021 Securities Purchase Agreement,
the August 2021 Offering, the October 2021 Offering, and the December 2021 Offering we received net proceeds of approximately $35,000,000
during the last twelve months. We believe that the funds raised will not be sufficient to fund our operations for the next 12 months
and such creates substantial doubt about our ability to continue as a going concern beyond one year.
Financial
Results
We have a limited operating
history. Therefore, there is limited historical financial information upon which to base an evaluation of our performance. Our prospects
must be considered in light of the uncertainties, risks, expenses, and difficulties frequently encountered by companies in their early
stages of operations. Our condensed financial statements as of March 31, 2022, show a net loss of $6,059,141. We expect to incur additional
net expenses over the next several years as we continue to maintain and expand our existing operations. The amount of future losses and
when, if ever, we will achieve profitability are uncertain.
Results
of Operations
Results
of operations for the three months ended March 31, 2022 and 2021
We
generated revenue of $210,279 and $0 for the three months ended March 31, 2022 and 2021, respectively. Cost of sales for the three months
ended March 31, 2022 and 2021 was $188,071 and $0, respectively.
During
the three months ended March 31, 2022, we incurred a loss from operations of $6,116,931. This is due to general and administrative expenses
of $4,624,158, which includes $451,987 in stock-based compensation, research and development of $1,428,382, which includes $149,288 in
stock-based compensation, and sales and marketing expenses of $86,599. The $1,428,382 in research and development is mainly comprised
of $499,938 in consulting expenses, and $828,411 in compensation offset by a one-time adjustment to research and development purchases.
During the quarter the Company transitioned from purchasing certain inventory items to internally manufacturing these items.
During
the three months ended March 31, 2021, we incurred a loss from operations of $6,093,032. This is due to general and administrative expenses
of $5,098,517, which includes $1,464,902 in stock-based compensation, research and development of $935,952, and sales and marketing expenses
of $58,563. The $935,952 in research and development is comprised of $69,360 in licensing fees, $505,564 in product development, and
$361,028 in other research and development expense.
The
increase in expenses during the three months ended March 31, 2022 compared to the three months ended March 31, 2021 was due to the Company
continuing to execute its business plan and incur costs of being a public company.
Liquidity
and Capital Resources
We
have incurred substantial operating losses since inception and expect to continue to incur significant operating losses for the foreseeable
future and may never become profitable. As of March 31, 2022, we had an accumulated deficit of $73,411,950. We had working capital deficit
of $73,629 as of March 31, 2022. During the three months ended March 31, 2022, we purchased $147,802 in fixed assets, for which we made
cash payments of $147,802. These fixed assets were purchased to continue the buildout of our operations. Approximately $89,000 of these
purchased fixed assets were lab equipment, $54,000 was for computers, and $5,000 was for office furniture.
20
Our
condensed financial statements have been prepared assuming that we will continue as a going concern.
We
have funded our operations from proceeds from the sale of equity and debt securities. On July 2, 2020, we completed our IPO and raised
approximately $9.5 million in net proceeds. At the time of the IPO, we believed that these funds would be sufficient to fund our operations
for the foreseeable future.
On
September 10, 2020, we completed a follow-on public offering. In connection therewith, we issued 2,400,000 units, or Follow-On Units,
excluding the underwriters’ option to cover overallotments, at an offering price of $4.00 per Follow-On Unit, resulting in gross
proceeds of approximately $9.6 million.
On
January 25, 2021, the Company entered into a securities purchase agreement with an institutional accredited investor (the “Investor”)
for the sale of a $6,000,000 senior secured convertible note (the “Convertible Note”). The Convertible Note had a term of
24 months, was originally convertible at a price of $4.00 per share and was issued at an original issuance discount of $1,000,000. On
August 30, 2021, the Company entered into a defeasance and waiver agreement with the Investor, pursuant to which the Noteholder has agreed
in exchange for (a) a cash payment by the Company to the Investor of $1.2 million (the Cash Payment”), (b) a waiver, in part of
the conversion price adjustment provision such that the January 2021 Note shall be convertible into 4,802,497 shares of common stock
(without giving effect to the conversion notice received by the company form the Noteholder prior to the date hereof totaling (1,005,748
shares) (the “Shares”), and (c) a voluntary and permanent reduction by the Company of the exercise price of the warrant to
purchase 800,000 shares of the common stock of the Company (the “January 2021 Warrant”) to $2.53 per share. As of March 31,
2022, the outstanding principle of the convertible note had been converted to 4,802,497 shares of common stock.
On
August 30, 2021, we completed a registered direct; offering and raised approximately $10.1 million in net proceeds.
On
October 20, 2021, we completed an offering for net proceeds of $3.8 million. As part of this offering, we issued 2,833,333 shares of
the Company’s common stock
On
December 6, 2021, we completed an offering for net proceeds of $16.0 million. As part of this offering, we issued 8,246,430 units consisting
of shares of the Company’s common stock and warrant to purchase shares of the Company’s common stock and 8,328,570 prefunded
warrants. The warrant issued as part of the units had an exercise price of $1.15 and the prefunded warrants had an exercise price of
$0.001.
We
may need to raise significant additional capital to continue to fund our operations and the clinical trials for our product candidates.
We may seek to sell common stock, preferred stock or convertible debt securities, enter into a credit facility or another form of third-party
funding or seek other debt financing. In addition, we may seek to raise cash through collaborative agreements or from government grants.
The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have
rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities,
or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party
funding arrangement could require us to relinquish valuable rights.
The
source, timing, and availability of any future financing will depend principally upon market conditions, and, more specifically, on the
progress of our clinical development program. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of
necessary funds may require us to, among other things, delay, scale back or eliminate expenses including some or all our planned development,
including our clinical trials. While we may need to raise funds in the future, we believe the current cash reserves should be sufficient
to fund our operation for the foreseeable future. Because of these factors, we believe that this creates doubt about our ability to continue
as a going concern.
Contractual
Obligations
The
following table shows our contractual obligations as of March 31, 2022:
Payment Due by Year
Total
2022
2023
2024
2025
2026
Lease
$ 4,270,602
$ 894,744
$ 1,149,247
$ 1,034,084
$ 708,804
$ 483,723
Financed asset
650,563
539,051
111,512
-
-
-
Total contractual obligations
$ 4,921,165
$ 1,433,795
$ 1,260,759
$ 1,034,084
$ 708,804
$ 483,723
21
Critical
Accounting Polices and Estimates
Our condensed financial statements
are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our condensed financial
statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets,
liabilities, revenue, costs and expenses, and related disclosures. We believe that our critical accounting policies described under the
heading “Management’s Discussion and Analysis of Financial Condition and Plan of Operations—Critical Accounting Policies”
in our Prospectus, dated September 1, 2020, filed with the SEC pursuant to Rule 424(b), are critical to fully understanding and evaluating
our financial condition and results of operations. The following involve the most judgment and complexity:
● Research
and development
● Stock-based
compensation expense
● Fair
value of common stock
Accordingly,
we believe the policies set forth above are critical to fully understanding and evaluating our financial condition and results of operations.
If actual results or events differ materially from the estimates, judgments and assumptions used by us in applying these policies, our
reported financial condition and results of operations could be materially affected.
Off-Balance
Sheet Arrangements
We
did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules
and regulations of the SEC.
JOBS
Act
On
April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company”
can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new
or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting
standards until those standards would otherwise apply to private companies.
When
favorable, we have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS
Act for complying with new or revised accounting standards until those standards would otherwise apply to private companies provided
under the JOBS Act.
We
are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject
to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions,
including without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial
reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted
by the Public Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement to the
auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion
and analysis. We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year
in which we have total annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth
anniversary of the date of the completion of our IPO (December 31, 2025); (iii) the date on which we have issued more than $1 billion
in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer
under the rules of the SEC.
22
Recently
Issued and Adopted Accounting Pronouncements
See Note 3 - Summary of Significant
Accounting Policies to the accompanying condensed financial statements for a description of other accounting policies and recently issued
accounting pronouncements.
Recent
Developments
See Note 11 – Subsequent
Event to the accompanying condensed financial statements for a description of material recent developments.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
We
are not required to provide the information required by this Item as we are a “smaller reporting company,” as defined in
Rule 229.10(f)(1).
Item
4. Controls and Procedures.
Disclosure
Controls and Procedures
In
accordance with Rules 13a-15(b) and 15d-15(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), we,
under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, carried out an evaluation
of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e)
of the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on the foregoing, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures were (a) designed to ensure that the information
we are required to disclose in our reports under the Exchange Act is recorded, processed, and reported in an accurate manner and on a
timely basis and the information that we are required to disclose in our Exchange Act reports is accumulated and communicated to management
to permit timely decisions with respect to required disclosure and (b) operating in an effective manner.
Change
in Internal Control Over Financial Reporting
No
change occurred in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) of the Exchange Act) during
the quarter ended March 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
23
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
From
time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. However,
litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may
harm our business.
Item
1A. Risk Factors
Our
business, financial condition, results of operations, and cash flows may be impacted by a number of factors, many of which are beyond
our control, including those set forth in our most recent Annual Report on Form 10-K and in our other filings with the SEC, the occurrence
of any one of which could have a material adverse effect on our actual results. There have been no material changes to the Risk Factors
previously disclosed in our Annual Report on Form 10-K and our other filings with the SEC.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
(a)
Sales of Unregistered Securities
On
January 31, 2022, the Company issued a consultant 3,000 shares of common stock for services rendered.
On
February 28, 2022, the Company issued a consultant 3,000 shares of common stock for services rendered.
On
March 31, 2022, the Company issued a consultant 3,000 shares of common stock for services rendered.
The
issuances above were made pursuant to Section 4(a)(2) of the Securities Act.
(b)
Use of Proceeds from Initial Public Offering
On
July 2, 2020, the Company completed its initial public offering (“IPO”). In connection therewith, the Company issued 1,226,668
Units (the “Units”), excluding the underwriters’ option to cover overallotments (the underwriter did not exercise their
overallotment), at an offering price of $9.00 per Unit, resulting in gross proceeds of approximately $11.0 million. The Units issued
in the IPO consisted of one share of common stock, one Series A warrant, and one Series B warrant. The Series A warrants originally had
an exercise price of $9.00 and a term of 5 years. In addition, the Company issued a Unit Purchase Option at an exercise price of $11.25
per unit to the underwriters to purchase up to 67,466 units, with each unit consisting of (i) one share of common stock and (ii) one
Series A Warrant. On August 19, 2020, the Company modified the exercise price of the Series A Warrants from $9.00 per share to $4.50
per share. The term of the Series A Warrants was not modified. The Series B warrants have an exercise price of $11.25 per share, a term
of 5 years and contain a cashless exercise option upon certain criteria being met. As of March 31, 2022, substantially all of the Series
B warrants issued in the IPO have been exercised pursuant to a cashless provision therein.
We
received net proceeds of $8.5 million in the IPO, after deducting underwriting discounts and commissions and issuance expenses borne
by us. No payments were made by us to directors, officers or persons owning ten percent or more of our common stock or to their associates,
or to our affiliates, other than payments in the ordinary course of business to officers for salaries and to non-employee directors pursuant
to our director compensation policy. Dawson James Securities, Inc. acted as lead book-running manager of the offering and as representative
of the underwriters for the offering.
There
has been no material change in the planned use of proceeds from our IPO from that described in the final prospectus related to the offering,
dated June 29, 2020 as filed with the SEC.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
Common
stock offering:
On May 14, 2022, the Company entered
into a securities purchase agreement (the “May 2022 Purchase Agreement”) with an accredited investor, pursuant to which the
Company agreed to issue and sell an aggregate of 8,333,334 shares of the Company’s common stock (the “Shares”) at a
per share purchase price of $0.30 for gross proceeds to the Company of $2.5 million. For each Share purchased, the investor also received
a warrant to purchase one share of the Company’s common stock (the “Warrants”). The Warrants have an exercise price
of $0.33 per share and are exercisable for a term of five years commencing six months from the date of closing. Pursuant to the May 2022
Purchase Agreement, the Company agreed to file a registration statement registering the Shares and the shares of common stock underlying
the Warrants within sixty days after the closing. The closing is expected to occur on or about May 20, 2022.
24
Item
6. Exhibits
Exhibit
Incorporated by Reference
Filed
Number
Exhibit Description
Form
File No.
Exhibit
Filing Date
Herewith
3.1
Amended and Restated Certificate of Incorporation of the Registrant.
S-1
333-235933
3.1
June 25, 2020
3.2
Certificate of Amendment, dated June 29, 2020
10-Q
001-39336
3.2
August 13, 2020
3.3
Amended and Restated Bylaws of the Registrant
S-1
333-235933
3.3
June 25, 2020
3.4
Second Amended and Restated Bylaws of the Registrant
10-Q
001-39336
3.4
August 12, 2021
10.1
Forbearance Agreement and Eight Amendment to Secured Credit Agreement dated as of March 31, 2022
X
10.2
Security Agreement between Cellvera Holdings and Aditxt, Inc. dated as of March 31, 2022
X
10.3
Security Agreement between Cellvera Development LLC and Aditxt, Inc. dated as of March 31, 2022
X
10.4
Security Agreement between Cellvera Global Holdings LLC and Aditxt, Inc. dated as of March 31, 2022
X
10.5
Amended and Restated Security Agreement between Cellvera Asia Limited and Aditxt, Inc. dated as of March 31, 2022
X
10.6
Revenue Sharing Agreement by and among Aditxt, Inc., Cellvera Global Holdings LLC and Cellvera Asia Limited dated as of March 31, 2022
X
10.7
Amendment to Share Exchange Agreement by and between AiPharma Group Ltd. and Aditxt, Inc. dated as of March 31, 2022
X
31.1*
Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
31.2*
Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
32.1*
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
X
101.INS
Inline XBRL Instance Document.
X
101.SCH
Inline XBRL Taxonomy Extension Schema Document.
X
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
X
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
X
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.
X
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
X
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
X
* This
certification is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (Exchange Act),
or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities
Act of 1933, as amended, or the Exchange Act.
25
SIGNATURES
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, thereunto duly authorized.
Aditxt,
Inc.
Date:
May 16, 2022
By:
/s/
Amro Albanna
Amro
Albanna
Chief
Executive Officer
(Principal Executive Officer)
Date:
May 16, 2022
By:
/s/
Thomas J. Farley
Thomas
J. Farley
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
26
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