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 June 30,
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 August 14, 2022, the registrant had 56,947,134
and 56,846,331 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 June 30, 2022 and December 31, 2021
1
Condensed Statements of Operations for the three and six months ended June 30, 2022 and 2021
2
Condensed Statements of Stockholders’ Equity for the three and six months ended June 30, 2022 and 2021
3
Condensed Statements of Cash Flows for the six months ended June 30, 2022 and 2021
5
Notes to Condensed Financial Statements
6
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
19
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
25
Item 4.
Controls and Procedures
25
PART II OTHER INFORMATION
Item 1.
Legal Proceedings
26
Item 1A.
Risk Factors
26
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
26
Item 3.
Defaults Upon Senior Securities
27
Item 4.
Mine Safety Disclosures
27
Item 5.
Other Information
27
Item 6.
Exhibits
27
Signatures
28
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)
June 30,
December 31,
2022
2021
ASSETS
CURRENT ASSETS:
Cash
$
803,971
$
7,872,061
Accounts receivable, net
410,593
89,844
Prepaid expenses
590,418
460,102
Note receivable
500,000
500,000
Inventory
1,332,895
494,697
TOTAL CURRENT ASSETS
3,637,877
9,416,704
Fixed assets, net
2,344,666
2,267,297
Intangible assets, net
160,500
214,000
ROU asset - long term
3,661,247
4,097,117
Deposits
410,837
379,250
Other assets
524,548
289,539
TOTAL ASSETS
$
10,739,675
$
16,663,907
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses
$
4,813,224
$
1,575,543
Notes payable, net of discount
465,848
-
Financing on fixed assets – current
438,398
700,433
Deferred rent
192,984
186,058
Lease liability - current
1,130,611
1,145,126
TOTAL CURRENT LIABILITIES
7,041,065
3,607,160
Financing on fixed assets - long term
-
110,041
Lease liability - long term
2,337,652
2,765,933
TOTAL LIABILITIES
9,378,717
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, 55,469,356 and 44,530,486 shares issued and 55,368,553 and 44,429,683 shares outstanding, respectively
55,473
44,534
Treasury stock, 100,803 and 100,803 shares, respectively
( 201,605
)
( 201,605
)
Additional paid-in capital
80,769,046
77,690,653
Accumulated deficit
( 79,261,956
)
( 67,352,809
)
TOTAL STOCKHOLDERS’ EQUITY
1,360,958
10,180,773
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
10,739,675
$
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
Six Months
Ended
Six Months
Ended
June 30,
2022
June 30,
2021
June 30,
2022
June 30,
2021
REVENUE
Sales
$ 214,715
$ -
$ 424,994
$ -
Cost of goods sold
174,858
-
362,929
-
Gross Profit
39,857
-
62,065
-
OPERATING EXPENSES
General and administrative expenses, $ 375,352 , $ 772,430 , $ 827,337 and $ 2,237,332 in stock-based compensation, respectively
3,788,952
4,798,313
8,413,110
9,896,830
Research and development, includes $ 154,237 , $ 0 , $ 303,527 and $ 0 in stock-based compensation, respectively
1,187,920
932,751
2,616,302
1,868,703
Sales and marketing $ 754,699 , $ 0 , $ 754,699 , and $ 0 in stock-based compensation, respectively
833,942
43,943
920,541
102,506
Total operating expenses
5,810,814
5,775,007
11,949,953
11,868,039
NET LOSS FROM OPERATIONS
( 5,770,957 )
( 5,775,007 )
( 11,887,888 )
( 11,868,039 )
OTHER EXPENSE
Interest expense
( 82,110 )
( 19,586 )
( 97,320 )
( 36,389 )
Interest income
6,007
180
20,047
429
Other income
-
-
58,960
-
Amortization of debt discount
( 2,946 )
( 384,023 )
( 2,946 )
( 654,104 )
Total other expense
( 79,049 )
( 403,429 )
( 21,259 )
( 690,064 )
Net loss before income taxes
( 5,850,006 )
( 6,178,436 )
( 11,909,147 )
( 12,558,103 )
Income tax provision
-
-
-
-
NET LOSS
$ ( 5,850,006 )
$ ( 6,178,436 )
$ ( 11,909,147 )
$ ( 12,558,103 )
Net loss per share - basic and diluted
$ ( 0.13 )
$ ( 0.42 )
$ ( 0.26 )
$ ( 0.88 )
Weighted average number of shares outstanding during the period - basic and diluted
45,560,639
14,563,699
45,073,383
14,198,485
See accompanying notes to the condensed financial
statements.
2
ADITXT, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’
EQUITY
THREE AND SIX MONTHS ENDED JUNE 30, 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
Stock option and warrant compensation
-
-
-
-
-
724,584
-
724,584
Issuance of restricted stock units for compensation
-
-
137,525
138
-
( 138 )
-
-
Restricted stock unit compensation
-
-
-
-
-
309,704
-
309,704
Exercise of warrants, modification of warrants, and issuance of warrants
-
-
8,970,947
8,971
-
1,194,798
-
1,203,769
Issuance of shares for services
-
-
1,534,243
1,534
-
248,466
-
250,000
Net loss
-
-
-
-
-
-
( 5,850,006 )
( 5,850,006 )
Balance June 30, 2022
-
-
55,368,553
55,473
( 201,605 )
80,769,046
( 79,261,956 )
1,360,958
See accompanying notes to the condensed financial
statements.
3
ADITXT, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’
EQUITY
THREE AND SIX MONTHS ENDED JUNE 30, 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 employee 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
Issuance of shares for services
-
-
68,000
68
-
181,792
-
181,860
Issuance of shares for employee compensation
-
-
130,000
130
-
331,370
-
331,500
Stock option and warrant compensation
-
-
-
-
-
259,070
-
259,070
Net loss
-
-
-
-
-
-
( 6,178,436 )
( 6,178,436 )
Balance June 30, 2021
-
$ -
14,688,248
$ 14,793
$ ( 201,605 )
$ 39,587,916
$ ( 33,437,281 )
$ 5,963,823
4
ADITXT, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
Six Months
Ended
Six Months
Ended
June 30,
2022
June 30,
2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
( 11,909,147
)
$
( 12,558,103
)
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation
1,885,563
2,237,332
Depreciation expense
196,704
166,529
Amortization of intangible assets
53,500
53,060
Amortization of debt discount
2,946
654,104
Changes in operating assets and liabilities:
Accounts receivable
( 320,749
)
-
Prepaid expenses
( 130,316
)
( 199,536
)
Inventory
( 838,198
)
-
Deposits
( 31,587
)
( 384,707
)
Accounts payable and accrued expenses
3,237,681
970,384
Net cash used in operating activities
( 7,853,603
)
( 9,060,937
)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of fixed assets
( 274,073
)
( 718,425
)
Tenant improvement allowance receivable
( 215,173
)
( 62,393
)
Notes receivable and accrued interest
( 19,836
)
-
Net cash used in investing activities
( 509,082
)
( 780,818
)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from note payable
550,000
5,000,000
Discount on note payable from offering costs
( 16,500
)
( 526,460
)
Repayments of note payable
( 70,598
)
-
Exercise of warrants
-
3,718,956
Exercise of warrants, modification of warrants, and issuance of warrants
1,203,769
-
Payments on financing on fixed asset
( 372,076
)
( 241,442
)
Net cash provided by financing activities
1,294,595
7,951,054
NET DECREASE IN CASH
( 7,068,090
)
( 1,890,701
)
CASH AT BEGINNING OF PERIOD
7,872,061
10,500,826
CASH AT END OF PERIOD
$
803,971
$
8,610,125
Supplemental cash flow information:
Cash paid for income taxes
$
-
$
-
Cash paid for interest expense
$
70,831
$
-
NON-CASH INVESTING AND FINANCING ACTIVITIES:
Lease liability recognized from right of use asset
$
-
$
2,806,427
Original offering discount on convertible 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 2021 Offering to fund certain obligations under the Credit Agreement. (See Note 4)
On December 6, 2021, we completed a public offering for net proceeds
of $ 16.0 million (the “December 2021 Offering”). As part of the December 2021 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 . On June 15, 2022, the Company entered an agreement with a holder of certain warrants in the December 2021 Offering. (See Note
10)
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 six months ended June 30, 2022, the Company had a net loss of $ 11,909,147 and negative cash
flow from operating activities of $ 7,853,603 . As of June 30, 2022, the Company’s cash balance was $ 803,971 . 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, SEC regulations limit the amount of funds we can
raise during any 12-month period pursuant to our effective shelf registration statement on Form S-3. We are currently subject to General
Instruction I.B.6 to Form S-3, or the Baby Shelf Rule, and the amount of funds we can raise through primary public offerings of securities
in any 12-month period using our shelf registration statement on Form S-3 is limited to one-third of the aggregate market value of the
voting and non-voting common stock held by non-affiliates. We are currently limited by the Baby Shelf Rule as of the filing of this Quarterly
Report, until such time as our public float exceeds $ 75 million. In addition to the shelf registration, the Company has the ability to
raise capital from equity or debt through private placements or public offerings pursuant to a registration statement on Form S-1. We
may also secure loans from related parties. 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 June 30, 2022
and June 30, 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 six
months ended June 30, 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 collectability of notes receivable, collectability and reserve on accounts receivable, the reserve on
insurance billing, and 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 June 30, 2022 and December 31, 2021, there was an allowance for doubtful accounts of $ 50,808 and zero , respectively.
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.
The Company recognizes revenue in the following
manner for the following types of customers:
Client Payers:
Client payers include physicians or
other entities for which services are billed based on negotiated fee schedules. The Company principally estimates the allowance for credit
losses for client payers based on historical collection experience and the period of time the receivable has been outstanding.
Cash Pay:
Customers are billed based on established
patient fee schedules or fees negotiated with physicians on behalf of their patients. Collection of billings is subject to credit risk
and the ability of the patients to pay.
Insurance:
Reimbursements from healthcare insurers are based on fee for service
schedules. Net revenues recognized consist of amounts billed net of contractual allowances for differences between amounts billed and
the estimated consideration the Company expects to receive from such payers, collection experience, and the terms of the Company’s
contractual arrangements.
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 six months ended June 30, 2022 and June 30, 2021, the Company incurred patent licensing fees
for the patents of $ 248,813 and $ 76,245 , 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 six months ended June 30, 2022 and June 30, 2021, the Company incurred
research and development costs of $ 2,616,302 and $ 1,868,703 , 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 June 30, 2022, 2,235,466 stock options, 865,900 unvested restricted
stock units, and 45,963,691 warrants were excluded from dilutive earnings per share as their effects were anti-dilutive. As
of June 30, 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 subsequently 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 of filing of this Quarterly Report, the regularly scheduled payments under the Forbearance Agreement have not
been made, and the note receivable remains fully impaired.
10
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. As of the date of filing of this Quarterly
Report, the Company has not received any payments from Cellvera Global pursuant to the Revenue Sharing Agreement.
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.
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 June 30, 2022, the outstanding principal
of the Target Company Loan is $ 500,000 and the accrued interest on the Loan is $ 22,356 .
NOTE 5 – FIXED ASSETS
The Company’s fixed assets include the following
on June 30, 2022:
Cost Basis
Accumulated
Depreciation
Net
Computers
$ 370,607
$ ( 136,034 )
$ 234,573
Lab Equipment
2,492,510
( 441,518 )
2,050,992
Office Furniture
56,656
( 5,367 )
51,289
Other Fixed Assets
8,605
( 793 )
7,812
Total Fixed Assets
$ 2,928,378
$ ( 583,712 )
$ 2,344,666
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 $ 99,852 and $ 100,286 ,
for the three months ended June 30, 2022 and 2021, respectively. Depreciation expense was $ 196,704 and $ 166,529 , for the six months
ended June 30, 2022 and 2021, respectively. None of the Company’s fixed assets serve as collateral against any loans as of June
30, 2022 and December 31, 2021, other than those subject to the financed asset liability.
11
NOTE 6 – INTANGIBLE ASSETS
The Company’s intangible assets include
the following on June 30, 2022:
Cost Basis
Accumulated
Amortization
Net
Proprietary Technology
$ 321,000
$ ( 160,500 )
$ 160,500
Total Intangible Assets
$ 321,000
$ ( 160,500 )
$ 160,500
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 $ 26,676 for
the three months ended June 30, 2022 and 2021, respectively. Amortization expense was $ 53,500 and $ 53,060 for the six months
ended June 30, 2022 and 2021, respectively. None of the Company’s intangible assets serve as collateral against any loans as of
June 30, 2022, and December 31, 2021.
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
$ 106,910 in stock-based compensation for the issuance of these vested and unvested restricted stock units during the period ended June
30, 2022. (Note 10)
NOTE 8 – NOTE PAYABLE
On May 27, 2022, the Company entered into an agreement for the purchase
and sale of future receipts (the “Future Receipts Agreement”) with a commercial funding source (the “Funder”)
pursuant to which the Company agreed to sell to the Funder certain future trade receipts in the aggregate amount of $ 792,000 (the “Future
Receipts Purchased Amount” for gross proceeds to the Company of $ 550,000 , less origination fees of $ 16,500 and professional service
fees of $ 13,500 . Pursuant to the Future Receipts Agreement, the Company granted the Funder a security interest in all of the Company’s
present and future accounts receivable in an amount not to exceed the Future Receipts Purchased Amount. The Purchased Amount shall be
repaid by the Company in 28 weekly installments with the final payment due on December 7, 2022.
As of June 30, 2022, the outstanding principal
amount is $ 465,848 . During the six months ended June 30, 2022, the Company has made a total of $ 141,429 in payments to the Funder, which
represents principal and interest.
NOTE 9 – 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 June 30, 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.
12
Lease Costs
Six Months
Ended
June 30,
2022
Six Months
Ended
June 30,
2021
Components of total lease costs:
Operating lease expense
$ 653,408
$ 259,293
Total lease costs
$ 653,408
$ 259,293
Lease Positions as of June 30, 2022 and December
31, 2021
ROU lease assets and lease liabilities for our
operating leases are recorded on the balance sheet as follows:
June 30,
2022
December 31,
2021
Assets
Right of use asset – long term
$ 3,661,247
$ 4,097,117
Total right of use asset
$ 3,661,247
$ 4,097,117
Liabilities
Operating lease liabilities – short term
$ 1,130,611
$ 1,145,126
Operating lease liabilities – long term
2,337,652
2,765,933
Total lease liability
$ 3,468,263
$ 3,911,059
Lease Terms and Discount Rate
Weighted average remaining lease term (in years) – operating leases
2.05
Weighted average discount rate – operating leases
8.00 %
13
NOTE 10 – 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 six months ended June 30, 2022, the
Company issued 1,543,243 shares of common stock and recognized expense of $ 253,719 in stock-based compensation for consulting
services. The Company also granted 582,200 Restricted Stock Units, 425,375 Restricted Stock Units vested and resulted in
the issuance of shares. As a result, the Company recognized expense of $ 687,375 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 six months ended June 30, 2021, the
Company issued 86,000 shares of common stock and recognized expense of $ 233,100 in stock-based compensation for consulting
services. The Company also issued 1,163,556 shares of common stock upon the exercise of warrants and received $ 3,718,956 in
cash proceeds. The Company granted 465,000 shares of restricted common stock for employee compensation and recognized expense
of $ 1,443,700 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 June 30, 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 six months ended June 30, 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 June 30, 2022
2,235,466
$ 3.40
6.25
14
Nonvested Stock Options
Number
Weighted-
Average
Exercise
Price
Nonvested on December 31, 2020
453,125
$ 2.17
Granted
-
-
Vested
( 210,625 )
2.19
Forfeited
-
-
Nonvested on June 30, 2022
242,500
$ 2.16
The Company recognized stock-based compensation
expense related to options granted and vesting expense of $ 387,246 during the six months ended June 30, 2022, of which $ 267,318 is
included in general and administrative expenses and $ 119,928 is included in research and development expenses in the accompanying
statements of operations. The remaining value to be expensed is $ 583,832 with a weighted average vesting term of 0.37 years
as of June 30, 2022. The Company recognized stock-based compensation expense related to options issued and vesting of $ 423,157 during
the six months ended June 30, 2021, which is included in general and administrative expenses in the accompanying statements of operations.
Warrants
During the six months ended June 30, 2022 the
Company granted 24,937,774 warrants. During the six months ended June 30, 2021, the Company granted 875,000 warrants.
For the six months ended June 30, 2022, the fair
value of each warrant granted was estimated using the assumption and/or factors in the Black-Scholes Model as follows:
Exercise price
$ 0.25 - 0.40
Expected dividend yield
0 %
Risk free interest rate
2.55 %- 3.38 %
Expected life in years
5.00 - 5.50
Expected volatility
147 %- 165 %
For the six months ended June 30, 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
24,937,774
0.27
5.35
Exercised
( 8,970,947 )
0.15
-
Expired or forfeited
( 73,100 )
5.84
-
Outstanding June 30, 2022
45,963,691
$ 0.96
4.67
15
Nonvested Warrants
Number
Weighted-
Average
Exercise
Price
Nonvested on December 31, 2021
4,628,334
$ 1.51
Granted
24,937,774
0.27
Vested
( 5,863,334 )
1.27
Forfeited
-
-
Nonvested on June 30, 2022
23,702,774
$ 0.27
The Company recognized stock-based compensation
expense related to warrants granted and vesting expense of $ 557,223 during the six months ended June 30, 2022, of which $ 52,524 is included
in general and administrative and $ 504,699 is included in sales and marketing in the accompanying Statements of Operations. The Company
recognized stock-based compensation expense related to warrants granted and vesting expense of $ 137,375 during the six months ended
June 30, 2021, respectively, which is included in general and administrative in the accompanying Statements of Operations. The remaining
value to be expensed is $ 1,196,506 with a weighted average vesting term of 2.74 years as of June 30, 2022.
On June 15, 2022, the Company entered an agreement
with a holder of certain of the Series C Warrants (the “Holder”). Pursuant to the agreement, the Holder has agreed to exercise
in cash 8,970,947 of its Series C Warrants at a reduced exercise price of $0.15 per Share (reduced from $1.15 per share), for gross proceeds
to the Company of approximately $1.35 million. As an inducement to such exercise, the Company has agreed to reduce the exercise price
of the Holder’s remaining Series C Warrants to purchase up to 2,457,623 Shares from $1.15 to $0.2479 per share, which will be non-exercisable
for a period of six months following the closing date. The modification of this exercise price resulted in an increase of $344,158 to
the fair value of the Series C Warrants. This modification was an inducement on the transaction and as such was recoded to equity resulting
in no net change to additional paid in capital. In addition, the Company issued to the Holder a new warrant to purchase up to 20,399,517
shares of the Company’s common stock at an exercise price of $0.2479 per share, which will be non-exercisable for a period of six
months following issuance date and have a term of five and one-half years. This inducement resulted in a total increase of $ 3,759,044
to the fair value of the warrants.
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
( 425,375 )
1.19
Forfeited
( 69,175 )
1.63
Nonvested June 30, 2022
865,900
$ 1.32
The Company recognized stock-based compensation
expense related to RSUs granted and vesting expense of $ 687,375 and zero during the six months ended June 30, 2022 and
June 30, 2021, respectively, of which, $ 503,775 is included in general and administrative and $ 183,600 is included in research
and development in the accompanying Statements of Operations. The remaining value to be expensed is $ 861,631 with a weighted average
vesting term of 0.77 years as of June 30, 2022.
During the six months ended June 30, 2022, the
Company granted a total of 582,200 RSUs. As of June 30, 2022, 425,375 of these RSUs vested and the Company issued 425,375 shares
of common stock for the 425,375 vested RSUs.
NOTE 11 – INCOME TAXES
The Company has incurred losses since inception.
During the six months ended June 30, 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 June 30, 2022.
As of June 30, 2022, the Company did not have
any amounts recorded pertaining to uncertain tax positions.
NOTE 12 – SUBSEQUENT EVENTS
Amendment to the Bylaws:
On July 8, 2022, the board of directors approved an
amendment to the amended and restated bylaws to lower the number of holders of the shares entitled to vote at a meeting of stockholders
constituting a quorum, in person or by proxy, from a majority to one-third.
16
Issuance of Series B Preferred Stock:
On July 19, 2022, the Company entered into a Subscription and Investment
Representation Agreement with its Chief Executive Officer (the "Purchaser"), pursuant to which the Company agreed to issue and
sell one (1) share of the Company's Series B Preferred Stock (the “Preferred Stock"), par value $ 0.001 per share, to the Purchaser
for $ 20,000 in cash.
The Company also filed a certificate
of designation (the "Certificate of Designation") with the Secretary of State of Delaware, effective as of the time of filing,
designating the rights, preferences, privileges and restrictions of the share of Preferred Stock. The Certificate of Designation provides
that the share of Preferred Stock will have 250,000,000 votes and will vote together with the outstanding shares of the Company's common
stock as a single class exclusively with respect to any proposal to amend the Company's Restated Certificate of Incorporation to effect
a reverse stock split of the Company's common stock. The Preferred Stock will be voted, without action by the holder, on any such proposal
in the same proportion as shares of common stock are voted. The Preferred Stock otherwise has no voting rights except as otherwise required
by the General Corporation Law of the State of Delaware.
The Preferred Stock is not convertible
into, or exchangeable for, shares of any other class or series of stock or other securities of the Company. The Preferred Stock has no
rights with respect to any distribution of assets of the Company, including upon a liquidation, bankruptcy, reorganization, merger, acquisition,
sale, dissolution or winding up of the Company, whether voluntarily or involuntarily. The holder of the Preferred Stock will not be entitled
to receive dividends of any kind.
The outstanding share of Preferred Stock shall be redeemed in whole,
but not in part, at any time (i) if such redemption is ordered by the Board of Directors in its sole discretion or (ii) automatically
upon the effectiveness of the amendment to the Certificate of Incorporation implementing a reverse stock split. Upon such redemption,
the holder of the Preferred Stock will receive consideration of $ 20,000 in cash.
Notice of Delisting:
On July 19, 2022, the Company
received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company that
it has not regained compliance with the minimum bid price rule in Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid Price Rule")
by July 18, 2022 and is not eligible for a second 180 day extension as the Company does not comply with the stockholders' equity initial
listing requirement for The Nasdaq Capital market. The letter also states that, unless the Company requests an appeal, the Company's securities
will be delisted from The Nasdaq Capital Market and will be suspended at the opening of business on July 28, 2022.
The Company submitted an appeal to Nasdaq, which stays
the delisting and suspension of the Company's securities pending the decision of the Nasdaq Hearings Panel. At the hearing, which is expected
to occur 30-45 days after the Company's request for appeal, the Company intends to present its views and its plans to regain compliance
with the Minimum Bid Price Rule to the Panel. There can be no assurance that the Company will obtain an extension period from the Panel
within which to regain compliance with the Minimum Bid Price Rule, or, if the Panel grants such an extension period, that the Company
will be able to evidence compliance with the Minimum Bid Price Rule before the extension period expires. It is the Company's understanding
that the Panel typically issues its decision within 30 days after the hearing.
Promissory Note:
On July 21, 2022, the Chief Executive Officer
loaned $80,000 to the Company. The loan was evidenced by an unsecured promissory note (the "Promissory Note"). Pursuant to the
terms of the Promissory Note, it will accrue interest at a rate of four and three-quarters percent (4.75%) per annum, the Prime rate on
the date of signing, and is due on the earlier of January 22, 2023, or an event of default.
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Convertible Note Financing:
On August 4, 2022, the Company entered into a
Securities Purchase Agreement (the "SPA") with certain accredited investors by the Company to the purchasers $ 1,477,778 in principal
amount 10 % Senior Secured Promissory Notes (the "August 2022 Notes"), resulting in gross proceeds to the Company of $ 1,330,000 ,
exclusive of placement agent commission and fees and other offering expenses. In addition, 1,477,778 shares of common stock as commitment
fees and warrants (the "August 2022 Warrants") to purchase up to 6,275,065 shares of the Company's common stock were issued.
The August 2022 Notes have a
maturity date of twelve (12) months from the date of issuance and are convertible at the option of the Investor at any time prior to maturity
in shares of Common Stock (the "Conversion Shares") at an initial conversion price of $0.2355 per share, subject to adjustment
under certain circumstances.
The August 2022 Warrants are
exercisable for a period of five (5) years from period commencing on the Commencement Date (as defined therein) and ending on 5:00 p.m.
eastern standard time on the date that is five (5) years after the date of issuance, at an exercise price of $0.2355, subject to adjustment
provided therein (including cashless exercise).
In connection with the Offering,
the Company will issue 312,942 shares to Crito Capital LLC.
The Company estimates that the
net proceeds from the transaction will be approximately $ 1,244,000 after deducting estimated transaction fees and expenses. The net proceeds
received by the Company from the transaction will be used for business development, working capital and other general corporate purposes.
Convertible Note Financing Follow On:
On August 11, 2022, the Company entered into a SPA
with certain accredited investors by the Company to the purchasers $555,556 in principal amount of the August 2022 Notes, resulting in
gross proceeds to the Company of $500,000. In addition, 555,556 shares of common stock as commitment fees and August 2022 Warrants to
purchase up to 2,359,046 shares of the Company's common stock were issued.
The August 2022 Notes have a maturity date of
twelve (12) months from the date of issuance and are convertible at the option of the Investor at any time prior to maturity in shares
of Conversion Shares at an initial conversion price of $0.2355 per share, subject to adjustment under certain circumstances.
The August 2022 Warrants are exercisable for a
period of five (5) years from period commencing on the Commencement Date (as defined therein) and ending on 5:00 p.m. eastern standard
time on the date that is five (5) years after the date of issuance, at an exercise price of $0.2355, subject to adjustment provided therein
(including cashless exercise).
The Company estimates that the net proceeds from
the transaction will be approximately $ 500,000 after deducting estimated transaction fees and expenses. The net proceeds received by the
Company from the transaction will be used for business development, working capital and other general corporate purposes.
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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.
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.
19
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).
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).
20
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.
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.
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Going Concern
We were incorporated on September 28, 2017 and have not generated significant
revenues to date. During the six months ended June 30, 2022 we had a net loss of $11,909,147 and cash of $803,971 as of June 30, 2022.
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 remaining funds on hand
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 June 30, 2022, show a net loss of $11,909,147. 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 June 30, 2022 and 2021
We generated revenue of $214,715
and $0 for the three months ended June 30, 2022 and 2021, respectively. Cost of sales for the three months ended June 30, 2022 and 2021
was $174,858 and $0, respectively.
During the three months ended June 30, 2022, we incurred a loss from
operations of $5,770,957. This is due to general and administrative expenses of $3,788,952, which includes $375,352 in stock-based compensation,
research and development of $1,187,920, which includes $154,237 in stock-based compensation, and sales and marketing expenses of $833,942,
which includes $754,699 in stock-based compensation. The $1,187,920 in research and development is mainly comprised of $602,434 in consulting
expenses, and $714,443 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 June 30, 2021, we incurred a loss from operations of $5,775,007. This is due to general and administrative expenses
of $4,798,313, which includes $772,430 in stock-based compensation, research and development of $932,751, and sales and marketing expenses
of $43,943. The $932,751 in research and development is comprised of $3,185 in licensing fees, $470,325 in product development, and $459,241
in other research and development expense.
The increase in expenses during
the three months ended June 30, 2022 compared to the three months ended June 30, 2021 was due to the Company continuing to execute its
business plan and incur costs of being a public company.
Results of operations for the six
months ended June 30, 2022 and 2021
We generated revenue of $424,994
and $0 for the six months ended June 30, 2022 and 2021, respectively. Cost of sales for the six months ended June 30, 2022 and 2021 was
$362,929 and $0, respectively.
During the six months ended
June 30, 2022, we incurred a loss from operations of $11,887,888. This is due to general and administrative expenses of $8,413,110, which
includes $827,337 in stock-based compensation, research and development of $2,616,302, which includes $303,527 in stock-based compensation,
and sales and marketing expenses of $920,541, which includes $754,699 in stock-based compensation. The $2,616,302 in research and development
is mainly comprised of $1,102,372 in consulting expenses, and $1,542,854 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 six months ended June 30, 2021, we incurred a loss from operations of $11,868,039. This is due to general and administrative expenses
of $9,896,830, which includes $2,237,332 in stock-based compensation, research and development of $1,868,703, and sales and marketing
expenses of $102,506. The $1,868,703 in research and development is comprised of $72,545 in licensing fees, $975,889 in product development,
and $820,269 in other research and development expense.
The increase in expenses during
the six months ended June 30, 2022 compared to the six months ended June 30 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 June 30, 2022, we had an accumulated deficit of $79,261,956. We had working capital deficit of $3,403,188 as
of June 30, 2022. During the six months ended June 30, 2022, we purchased $274,073 in fixed assets, for which we made cash payments of
$274,073. These fixed assets were purchased to continue the buildout of our operations. Approximately $215,000 of these purchased fixed
assets were lab equipment, $54,000 was for computers, and $5,000 was for office furniture.
22
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 June 30, 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 June 30, 2022:
Payment Due by Year
Total
2022
2023
2024
2025
2026
Lease
$ 3,975,797
$ 599,939
$ 1,149,247
$ 1,034,084
$ 708,804
$ 483,723
Financed asset
451,392
339,880
111,512
-
-
-
Total contractual obligations
$ 4,427,189
$ 939,819
$ 1,260,759
$ 1,034,084
$ 708,804
$ 483,723
23
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.
24
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 June
30, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
25
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.
The Company received a written
notice from Nasdaq that it has not regained compliance with the minimum bid price rule in Nasdaq Listing Rule 5550(a)(2) by July 18, 2022
and is not eligible for a second 180 day extension as the Company does not comply with the stockholders’
equity initial listing requirement for The Nasdaq Capital market. Accordingly, the notice indicated that unless the Company requests
an appeal of Nasdaq’s determination, the Company’s securities will be delisted from The Nasdaq Capital market and suspended
at the opening of business on July 28, 2022. The Company has requested an appeal, however, the Company can provide no assurance as to
whether or not it will be successful in its appeal and maintain its listing on The Nasdaq Capital Market.
On
July 19, 2022, the Company received a letter from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market
LLC ("Nasdaq") notifying the Company that it has not regained compliance with the minimum bid price rule in Nasdaq Listing Rule
5550(a)(2) (the “Minimum Bid Price Rule”) by July 18, 2022 and is not eligible for a second 180 day extension as the Company
does not comply with the stockholders’ equity initial listing requirement for The Nasdaq Capital market. The letter also states
that, unless the Company requests an appeal, the Company’s securities will be delisted from The Nasdaq Capital Market and will be
suspended at the opening of business on July 28, 2022.
On
July 28, 2022, the Company submitted its request for an appeal to Nasdaq, which stays the delisting and suspension of the Company’s
securities pending the decision of the Nasdaq Hearings Panel (the “Panel”). At the hearing, which is scheduled to occur on
September 8, 2022, the Company intends to present its views and its plans to regain compliance with the Minimum Bid Price Rule to the
Panel. There can be no assurance that the Company will obtain an extension period from the Panel within which to regain compliance with
the Minimum Bid Price Rule, or, if the Panel grants such an extension period, that the Company will be able to evidence compliance with
the Minimum Bid Price Rule before the extension period expires. It is the Company’s understanding that the Panel typically issues
its decision within 30 days after the hearing.
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.
On June 27, 2022, the Company
issued a consultant 1,534,243 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 June 30, 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.
26
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
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
3.5
Certificate of Designation of Series B Preferred Stock, dated July 19, 2022
8-K
001-39336
3.1
July 19, 2022
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.
27
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: August 15, 2022
By:
/s/ Amro Albanna
Amro Albanna
Chief Executive Officer
(Principal Executive Officer)
Date: August 15, 2022
By:
/s/ Thomas J. Farley
Thomas J. Farley
Chief Financial Officer
(Principal Financial and Accounting Officer)
28
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.