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, 2021
☐
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 000-05576
AIKIDO PHARMA INC.
(Exact name of registrant as specified in its charter)
Delaware 52-0849320
(State or other jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)
One Rockefeller Plaza , 11 th Floor , New York , NY 10020
(Address of Principal Executive Offices, including zip code)
( 703 ) 992-9325
(Registrant’s telephone number, including area code)
Not
Applicable
(Former
name, former address and former fiscal year, if changed since last report)
Indicate
by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the 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 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 an emerging growth company. See definition 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 ☒
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, $0.0001 par value AIKI The Nasdaq Capital Market LLC
As of August 11, 2021, there were 89,681,146 shares
of the Company’s common stock issued and outstanding.
AIKIDO
PHARMA INC.
Form
10-Q
For
the Quarter Ended June 30, 2021
Index
Page
No.
Part I. Financial Information
Item 1.
Financial Statements (Unaudited)
1
Condensed Consolidated Balance Sheets as of June 30, 2021 (Unaudited) and December 31, 2020
1
Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2021 and 2020 (Unaudited)
2
Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and six months ended June 30, 2021 and 2020 (Unaudited)
3
Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2021 and 2020 (Unaudited)
5
Notes to the Condensed Consolidated Financial Statements
6
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
12
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
14
Item 4.
Controls and Procedures
14
Part II. Other Information
Item 1.
Legal Proceedings
15
Item 1A.
Risk Factors
15
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
15
Item 6.
Exhibits
15
Signatures
16
i
PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements
AIKIDO
PHARMA INC.
Condensed
Consolidated Balance Sheets
($
in thousands except share and per share amounts)
June 30,
December 31,
2021
2020
(Unaudited)
ASSETS
Current assets
Cash and cash equivalents
$ 7,718
$ 2,715
Marketable securities
87,832
24,801
Prepaid expenses and other assets
176
215
Short-term investment
1,866
-
Deposits
4,476
-
Total current assets
102,068
27,731
Convertible note receivable
2,067
-
Investments
-
2,764
$ 104,135
$ 30,495
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable and accrued expenses
$ 319
$ 567
Accrued salaries and benefits
733
310
Total current liabilities
1,052
877
Total liabilities
1,052
877
Commitments and contingencies
Stockholders’ equity
Preferred stock, $ .0001 par value, 50,000,000 Authorized
Series D: 5,000,000 shares designated; 4,725 shares issued and outstanding at June 30, 2021 and December 31, 2020; liquidation value of $ 0.0001 per share
-
-
Series D-1: 5,000,000 shares designated; 834 shares issued and outstanding at June 30, 2021 and December 31, 2020; liquidation value of $ 0.0001 per share
-
-
Common stock, $0.0001 par value, 100,000,000 shares authorized; 89,531,149 and 34,920,222 shares issued at June 30, 2021 and December 31, 2020, respectively; 89,531,146 and 34,920,219 shares outstanding at June 30, 2021 and December 31, 2020, respectively
9
3
Additional paid-in capital
265,255
186,482
Treasury stock, at cost, 3 shares at June 30, 2021 and December 31, 2020
( 264 )
( 264 )
Accumulated deficit
( 161,917 )
( 156,603 )
Total stockholders’ equity
103,083
29,618
Total liabilities and stockholders’ equity
$ 104,135
$ 30,495
See
accompanying notes to condensed consolidated financial statements
1
AIKIDO
PHARMA INC.
Condensed
Consolidated Statements of Operations
($
in thousands except share and per share amounts)
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2021
2020
2021
2020
Operating costs and expenses
General and administrative
$ 2,343
$ 1,017
$ 3,555
$ 2,320
Research and development
325
675
397
760
Research and development - license acquired
91
102
1,125
1,113
Total operating expenses
2,759
1,794
5,077
4,193
Loss from operations
( 2,759 )
( 1,794 )
( 5,077 )
( 4,193 )
Other income (expenses)
Other income
-
15
135
15
Interest income
40
-
67
-
Gains on marketable securities
1,798
1,125
459
262
Change in fair value of investment
( 431 )
( 1,659 )
( 898 )
( 6,730 )
Total other income (expenses)
1,407
( 519 )
( 237 )
( 6,453 )
Net loss
$ ( 1,352 )
$ ( 2,313 )
$ ( 5,314 )
$ ( 10,646 )
Net loss per share, basic and diluted
Basic and Diluted
$ ( 0.02 )
$ ( 0.07 )
$ ( 0.07 )
$ ( 0.50 )
Weighted average number of shares outstanding, basic and diluted
Basic and Diluted
89,595,614
32,975,170
75,019,737
21,085,382
See
accompanying notes to condensed consolidated financial statements
2
AIKIDO
PHARMA INC.
Condensed
Consolidated Statements of Changes in Stockholders’ Equity
($
in thousands except share and per share amounts)
(Unaudited)
For
the Three Months Ended June 30, 2021
Common Stock
Preferred Stock
Additional
Paid-in
Treasury Stock
Accumulated
Total Stockholders’
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Equity
Balance at March 31, 2021
89,531,146
$ 9
5,559
$ -
$ 265,192
3
$ ( 264 )
$ ( 160,565 )
$ 104,372
Stock-based compensation
-
-
-
-
63
-
-
-
63
Net loss
-
-
-
-
-
-
-
( 1,352 )
( 1,352 )
Balance at June 30, 2021
89,531,146
$ 9
5,559
$ -
$ 265,255
3
$ ( 264 )
$ ( 161,917 )
$ 103,083
For
the Three Months Ended June 30, 2020
Common
Stock
Preferred
Stock
Additional
Paid-in
Treasury
Stock
Accumulated
Total Stockholders’
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Equity
Balance at
March 31, 2020
20,857,909
$ 2
5,559
$ -
$ 173,836
3
$ ( 264 )
$ ( 152,599 )
$ 20,975
Issuance of common stock,
net of offering cost
14,000,000
1
-
-
12,766
-
-
-
12,768
Common warrant and prefunded
warrant exercise
62,310
-
-
-
65
-
-
-
65
Net
loss
-
-
-
-
-
-
-
( 2,313 )
( 2,313 )
Balance
at June 30, 2020
34,920,219
$ 3
5,559
$ -
$ 186,667
3
$ ( 264 )
$ ( 154,912 )
$ 31,494
See
accompanying notes to condensed consolidated financial statements
3
AIKIDO
PHARMA INC.
Condensed
Consolidated Statements of Changes in Stockholders’ Equity
($
in thousands except share and per share amounts)
(Unaudited)
For
the Six Months Ended June 30, 2021
Common Stock
Preferred Stock
Additional
Paid-in
Treasury Stock
Accumulated
Total Stockholders’
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Equity
Balance at December 31, 2020
34,920,219
$ 3
5,559
$ -
$ 186,482
3
$ ( 264 )
$ ( 156,603 )
$ 29,618
Issuance of common stock and warrants (net of offering costs of $8,260)
53,905,927
6
-
-
77,983
-
-
-
77,989
Exercise of warrants
80,000
-
-
-
84
-
-
-
84
Issuance of common stock for research and development license acquired
625,000
-
-
-
531
-
-
-
531
Stock-based compensation
-
-
-
-
175
-
-
-
175
Net loss
-
-
-
-
-
-
-
( 5,314 )
( 5,314 )
Balance at June 30, 2021
89,531,146
$ 9
5,559
$ -
$ 265,255
3
$ ( 264 )
$ ( 161,917 )
$ 103,083
For
the Six Months Ended June 30, 2020
Common
Stock
Preferred
Stock
Additional
Paid-in
Treasury
Stock
Accumulated
Total
Stockholders’
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Equity
Balance
at December 31, 2019
4,825,549
$ -
5,559
$ -
$ 155,062
3
$ ( 264 )
$ ( 144,266 )
$ 10,532
Issuance
of common stock, common warrants and prefunded warrants, net of offering cost
3,245,745
-
-
-
6,559
-
-
-
6,559
Issuance
of common stock, net of offering cost
16,090,909
2
-
-
17,843
-
-
-
17,845
Common
warrant and prefunded warrant exercise
10,758,016
1
-
-
7,203
-
-
-
7,204
Net
loss
-
-
-
-
-
-
-
( 10,646 )
( 10,646 )
Balance
at June 30, 2020
34,920,219
$ 3
5,559
$ -
$ 186,667
3
$ ( 264 )
$ ( 154,912 )
$ 31,494
See
accompanying notes to condensed consolidated financial statements
4
AIKIDO
PHARMA INC.
Condensed
Consolidated Statements of Cash Flows
($
in thousands)
(Unaudited)
Six Months Ended
June 30,
2021
2020
Cash flows from operating activities
Net loss
$ ( 5,314 )
$ ( 10,646 )
Adjustments to reconcile net loss to net cash used in operating activities:
Change in fair value of investment
898
6,730
Research and development-acquired license, expensed
1,125
1,113
Stock-based compensation
175
-
Realized gain on marketable securities
( 1,084 )
( 544 )
Unrealized loss on marketable securities
1,395
614
Changes in assets and liabilities:
Prepaid expenses and other assets
39
76
Accounts payable and accrued expenses
( 248 )
608
Accrued salaries and benefits
423
( 389 )
Interest receivable on convertible note
( 67 )
-
Payable to DatChat
-
50
Net cash used in operating activities
( 2,658 )
( 2,388 )
Cash flows from investing activities
Purchase of marketable securities
( 86,497 )
( 78,042 )
Sale of marketable securities
23,155
52,215
Sale of Hoth common shares
-
460
Funds to deposit accounts, net
( 4,476 )
-
Purchase of research and development licenses
( 594 )
( 1,113 )
Purchase of convertible note
( 2,000 )
-
Net cash used in investing activities
( 70,412 )
( 26,480 )
Cash flows from financing activities
Proceeds from issuance of common stock and warrants, net of offering cost
77,989
6,559
Proceeds from issuance of common stock, net of offering cost
-
17,845
Proceeds from exercise of warrants
84
7,204
Net cash provided by financing activities
78,073
31,608
Net increase in cash and cash equivalents
5,003
2,740
Cash and cash equivalents, beginning of period
2,715
91
Cash and cash equivalents, end of period
$ 7,718
$ 2,831
See
accompanying notes to condensed consolidated financial statements
5
AIKIDO PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note 1. Organization and Description of Business and Recent Developments
Organization and Description of Business
AIkido Pharma Inc. (the “Company”
and “We”), formerly known as Spherix Incorporated, was initially formed in 1967. Since 2017, the Company has operated
as a biotechnology company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics in development. The Company’s
pipeline consists of patented technology from leading universities and researchers. The Company is currently in the process of developing
its innovative therapeutic drug pipeline through strong partnerships with world renowned educational institutions, including the University
of Texas at Austin, the University of Maryland, Baltimore and Wake Forest University. The Company’s oncology therapeutics include
prospective treatments for pancreatic cancer, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The Company is also
developing a broad-spectrum antiviral platform, in which the lead compounds have activity in cell-based assays against multiple viruses
including Influenza virus, Ebolavirus and Marburg virus, SARS-CoV, MERS-CoV, and SARS-CoV-2, the cause of COVID-19.
As a result of the Company’s biotechnology
research and development and associated investments and acquisitions, its business portfolio now focuses on the treatment of three different
cancers and multiple types of viral infections. The Company’s pancreatic drug candidate, DHA-dFdC, developed at and licensed from
the University of Texas at Austin, is a new compound that it hopes will become the next generation of chemotherapy treatment for advanced
pancreatic cancer. DHA-dFdC overcomes tumor cell resistance to current chemotherapeutic drugs and is well tolerated in preclinical toxicity
tests. Preclinical studies have also indicated that DHA-dFdC inhibits pancreatic cancer cell growth (up to 100,000-fold more potent that
gemcitabine, a current standard therapy), targets pancreatic tumors and has demonstrated activities against other cancers. The Company
has also executed a Sponsored Research Agreement with UMB to support the development of the technology under the direction of these inventors
at UMB.
Note 2. Liquidity and Capital Resources
The Company continues to incur ongoing administrative
and other expenses, including public company expenses, in excess of corresponding (non-financing related) revenue. While the Company continues
to implement its business strategy, it intends to finance its activities through managing current cash on hand from the Company’s
past debt and equity offerings.
During the first quarter of 2021, the Company
consummated a public offering of 53,905,927 shares of common stock (including the underwriter overallotment). The Company received net
proceeds of approximately $ 78.0 million after deducting underwriting discounts and commissions and estimated offering expenses payable
by the Company. Based upon projected cash flow requirements, the Company has adequate cash to fund its operations for at least the next
twelve months from the date of the issuance of these consolidated financial statements.
Note 3. Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying unaudited condensed consolidated
interim financial statements include the accounts of the Company and its wholly-owned subsidiaries, Nuta Technology Corp. (“Nuta”),
Spherix Portfolio Acquisition II, Inc. (“SPAII”), Guidance IP, LLC (“Guidance”), Directional IP, LLC (“Directional”),
Spherix Management Services, LLC (“SMS”), Spherix Delaware Merger Sub Inc. (“Merger Sub”), Spherix Merger Subsidiary,
Inc (“SMSI”) and NNPT, LLC (“NNPT”). All significant intercompany balances and transactions have been eliminated
in consolidation.
The accompanying unaudited condensed consolidated
financial statements of the Company have been prepared in accordance with the accounting principles generally accepted in the United States
of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of
Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual
audited consolidated financial statements. The condensed consolidated balance sheet as of June 30, 2021, condensed consolidated statements
of operations for the three and six months ended June 30, 2021 and 2020, condensed consolidated statements of stockholders’ equity
for the three and six months ended June 30, 2021 and 2020, and the condensed consolidated statements of cash flows for the six months
ended June 30, 2021 and 2020 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company
considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The
results for the three and six months ended June 30, 2021 are not necessarily indicative of results to be expected for the year ending
December 31, 2021 or for any future interim period. The condensed consolidated balance sheet at December 31, 2020 has been derived from
audited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial
statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the consolidated
financial statements for the year ended December 31, 2020 and notes thereto included in the Company’s annual report on Form 10-K,
which was filed with the SEC on March 25, 2021.
6
AIKIDO PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Use of Estimates
The accompanying condensed consolidated financial
statements have been prepared in conformity with US GAAP. This requires management to make estimates and assumptions that affect certain
reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the consolidated financial
statements, and the reported amounts of revenue and expenses during the period. The Company’s significant estimates and assumptions
include stock-based compensation, the valuation of investments, the valuation of convertible note and the valuation allowance related
to the Company’s deferred tax assets. Certain of the Company’s estimates could be affected by external conditions, including
those unique to the Company and general economic conditions. It is reasonably possible that these external factors could have an effect
on the Company’s estimates and could cause actual results to differ from those estimates and assumptions.
Significant Accounting Policies
Other than as described below, there have been
no material changes in the Company’s significant accounting policies to those previously disclosed in the Company’s annual
report on Form 10-K, which was filed with the SEC on March 25, 2021.
Fair Value Option - Convertible Note
The guidance in ASC 825, Financial Instruments ,
provides a fair value option election that allows entities to make an irrevocable election of fair value as the initial and subsequent
measurement attribute for certain eligible financial assets and liabilities. Unrealized gains and losses on items for which the fair value
option has been elected are reported in earnings. The decision to elect the fair value option is determined on an instrument-by-instrument
basis and must be applied to an entire instrument and is irrevocable once elected. Assets and liabilities measured at fair value pursuant
to this guidance are required to be reported separately in our condensed consolidated balance sheets from those instruments using another
accounting method.
Deposits
During the three months ended June 30, 2021, the Company deposited
$ 5 million with a fund to identify opportunities to expand the Company’s core business strategies in Asia. The cash are held in
bank accounts on behalf of the Company until the fund manager identifies investments. During the three months ended June 30, 2021, the
Company incurred fees of approximately $ 0.5 million advisory fees and the balance held in cash in this fund was $ 4.5 million as of June
30, 2021.
Recently Adopted Accounting Standards
In December 2019, the Financial Accounting Standards
Board (“FASB”) issued ASU No. 2019-12, “ Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU
2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions
to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance
is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted.
The Company adopted ASU No. 2019-12 effective January 1, 2021, and the adoption did not have a material impact on its consolidated financial
statements.
Note 4. License agreement with Silo Pharma
Inc.
Effective January 5, 2021, the Company entered
into an exclusive patent license agreement (the “License Agreement”) with Silo Pharma Inc., a Delaware corporation and Silo
Pharma Inc., a Florida corporation, and their affiliates/subsidiaries (collectively, “Silo Pharma”). On April 12, 2021, the
Company entered into an amendment to the License Agreement (“Amendment”). The Amendment amended a portion of the license fees
included in the original License Agreement and exchange 500 shares of the Company’s Series M Convertible Preferred Stock to an
aggregate of 625,000 restricted shares of the Company’s common stock, par value $ 0.001 per share, effective as of January 5, 2021.
The Company paid a one-time nonrefundable cash payment of $ 0.5 million to Silo Pharma. The Company shall also pay Silo Pharma a running
royalty equal to 2 % of “net sales” (as such term is defined in the License Agreement).
7
AIKIDO PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note 5. Investments in Marketable Securities
The realized gain or loss, unrealized gain or
loss, and dividend income related to marketable securities for the three and six months ended June 30, 2021 and 2020, which are recorded
as a component of gains and (losses) on marketable securities on the consolidated statements of operations, are as follows ($ in thousands):
For the Three
Months Ended
June 30,
For the Six
Months Ended
June 30,
2021
2020
2021
2020
Realized gain (loss)
$ 661
$ 597
$ 1,084
$ 544
Unrealized gain (loss)
653
212
( 1,395 )
( 614 )
Dividend income
484
246
770
259
Interest income
-
-
-
4
$ 1,798
$ 1,055
$ 459
$ 193
Note 6. Investment in Hoth Therapeutics, Inc.
The following summarizes the Company investment
in Hoth as of June 30, 2021:
Security Name
Shares Owned
as of
June 30,
2021
Fair value per Share
as of
June 30,
2021
Fair value
as of
June 30,
2021
(in thousands)
HOTH
1,166,415
$ 1.60
$ 1,866
Note 7. Fair Value of Financial Assets and
Liabilities
Financial instruments, including cash and cash
equivalents, accounts payable and accrued liabilities are carried at cost, which management believes approximates fair value due to the
short-term nature of these instruments. The Company measures the fair value of financial assets and liabilities based on the exchange
price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market
for the asset or liability in an orderly transaction between market participants on the measurement date. The Company maximizes the use
of observable inputs and minimizes the use of unobservable inputs when measuring fair value.
The Company uses three levels of inputs that may
be used to measure fair value:
Level 1 - quoted prices in active markets for
identical assets or liabilities
Level 2 - quoted prices for similar assets and
liabilities in active markets or inputs that are observable
Level 3 - inputs that are unobservable (for example,
cash flow modeling inputs based on assumptions)
The following table presents the Company’s
assets and liabilities that are measured at fair value at June 30, 2021 and December 31, 2020 ($ in thousands):
Fair value measured at June 30, 2021
Total at June 30,
Quoted prices in active markets
Significant other observable inputs
Significant unobservable inputs
2021
(Level 1)
(Level 2)
(Level 3)
Assets
Marketable securities:
Equities
$ 62,306
$ 62,306
$ —
$ —
Mutual fund securities
$ 25,013
$ 25,013
$ —
$ —
Unit Investments Trust
$ 513
$ 513
$ —
$ —
$ 87,832
$ 87,832
$ —
$ —
Short-term investment
$ 1,866
$ 1,866
$ —
$ —
Convertible note receivable
$ 2,067
$ —
$ —
$ 2,067
8
AIKIDO
PHARMA INC.
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
Fair value measured at December 31, 2020
Total at
December 31,
Quoted prices in active markets
Significant other observable inputs
Significant unobservable inputs
2020
(Level 1)
(Level 2)
(Level 3)
Assets
Marketable securities
$ 24,801
$ 24,801
$ -
$ -
Investments
$ 2,764
$ 2,764
$ -
$ -
Level 3 Valuation Techniques
The following table sets forth a summary of the
changes in the fair value of the Company’s Level 3 financial assets that are measured at fair value on a recurring basis:
Fair Value of Level 3
investment
June 30,
2021
December 31,
2020
Beginning balance
$ -
$ -
Purchase of convertible note
2,000
-
Accrued interest receivable
67
-
Ending balance
$ 2,067
$ -
Convergent Investment
On January 29, 2021, the Company purchased an
8 % convertible promissory note (“Convertible Note”) issued by Convergent Therapeutics, Inc. (“Convergent”) with
a principal amount of $ 2 million pursuant to a Note Purchase Agreement with Convergent. The Company paid a purchase price for the Convertible
Note of $ 2 million. The Company will receive interest on the Convertible Note at the rate of 8 % per annum payable upon conversion or maturity
of the Convertible Note. The Convertible Note shall mature on January 29, 2023.
The Company has elected to measure the purchase
of the Convertible Note from Convergent using the fair value option at each reporting date. Under the fair value option, bifurcation of
an embedded derivative is not necessary, and all related gains and losses on the host contract and derivative due to change in the fair
value will be reflected in interest income and other, net in the condensed consolidated statements of operations.
The Convertible Note is disclosed as a noncurrent
Convertible Note investment in the condensed consolidated balance sheets. As of June 30, 2021, the fair value of the Convertible Note
was measured at $ 2.0 million, taking into consideration cost of the investment, market participant inputs, market conditions, liquidity,
operating results and other qualitative and quantitative factors. The value at which the Company’s Convertible Note is carried on
its books is adjusted to estimated fair value at the end of each quarter, taking into account general economic and stock market conditions
and those characteristics specific to the underlying investments. No change in fair value was recorded during the six months ended June
30, 2021.
Interest accrues on the unpaid principal balance
on a quarterly basis and is recognized in interest income in the condensed consolidated statements of operations. The Company recorded
an interest income receivable of approximately $ 67,000 on the
Convertible Note as of June 30, 2021.
Note 8. Net Loss per Share
Basic loss per common share is computed by dividing
the net loss allocable to common stockholders by the weighted-average number of shares of common stock or common stock equivalents outstanding.
Diluted loss per common share is computed similar to basic loss per share except that it reflects the potential dilution that could occur
if dilutive securities or other obligations to issue common stock were exercised or converted into common stock. Securities that could
potentially dilute loss per share in the future that were not included in the computation of diluted loss per share at June 30, 2021 and
2020 are as follows:
As of June 30,
2021
2020
Convertible preferred stock
688
688
Warrants to purchase common stock
5,801,701
734,501
Options to purchase common stock
479,654
88,950
Total
6,282,043
824,139
9
AIKIDO
PHARMA INC.
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
Note 9. Stockholders’ Equity and Convertible
Preferred Stock
Public Offering
On February 19, 2021, the Company consummated
the public offering pursuant to an amended and restated underwriting agreement (the “Underwriting Agreement”) with H.C. Wainwright
& Co., LLC, as representative to the underwriters named therein (the “Underwriter”), pursuant to which the Company agreed
to issue and sell to the Underwriter in an underwritten public offering (the “Offering”) an aggregate of 46,875,000 shares
(the “Shares”) of common stock, $ 0.0001 par value per share, of the Company (the “Common Stock”). The Company
received gross proceeds of approximately $ 75 million before deducting underwriting discounts and commissions and estimated offering expenses
payable by the Company. On February 23, 2021, the Underwriter partially exercised its over-allotment option and purchased an additional
7,030,927 Shares, resulting in aggregate proceeds of approximately $ 86.2 million, before deducting underwriting discounts and commissions
and other expenses. The total net proceeds received from these two offerings were approximately $ 78.0 million.
In connection with the Offering, the Company issued
the Underwriter warrants (the “Underwriter’s Warrants”) to purchase up to 4,312,473 shares of Common Stock, or 8 % of
the Shares sold in the Offering. The Underwriter’s Warrants will be exercisable for a period of five years from February 19, 2021
at an exercise price of $ 2.00 per share, subject to adjustment.
Warrants
A summary of warrant activity for the six months
ended June 30, 2021 is presented below:
Warrants
Weighted Average Exercise Price
Total Intrinsic Value
Weighted Average Remaining Contractual Life
(in years)
Outstanding as of December 31, 2020
1,723,020
$ 3.07
57,333
1.11
Issued
4,312,473
2.00
-
4.64
Exercised
( 80,000 )
1.05
-
-
Expired
( 153,789 )
19.67
-
-
Forfeited
( 3 )
16.15
-
-
Outstanding as of June 30, 2021
5,801,701
$ 1.86
63,333
4.37
Stock Options
A summary of stock option activity for the six
months ended June 30, 2021 is presented below:
Number of Shares
Weighted Average Exercise Price
Total Intrinsic Value
Weighted Average Remaining
Contractual Life
(in years)
Outstanding as of December 31, 2020
384,304
$ 40.15
$ 69,000
8.9
Employee options granted
100,000
1.24
-
9.6
Employee options expired
( 4,650 )
-
-
-
Outstanding as of June 30, 2021
479,654
$ 32.35
$ 96,000
8.7
Options vested and exercisable
429,654
$ 35.97
$ 96,000
8.6
10
AIKIDO PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Stock-based compensation associated with the amortization
of stock option expense was approximately $ 63,000 and $ 0 for the three months ended June 30, 2021 and 2020, respectively. Stock-based
compensation associated with the amortization of stock option expense was approximately $ 0.2 million and $ 0 for the six months ended June
30, 2021 and 2020, respectively. All stock compensation was recorded as a component of general and administrative expenses.
Estimated future stock-based compensation expense
relating to unvested stock options is approximately $ 6,000 and will be recorded through July 2021.
Restricted Stock Awards
Pursuant to the patent license agreement effective
January 5, 2021 with Silo Parma Inc., the Company issued and delivered to Silo Pharma 625,000 shares of the Company’s restricted
stock as consideration for the license of the licensed patents. This restricted stock award vested immediately. The Company recorded approximately
$ 0.5 million in research and development expense related with license acquired during the six months ended June 30, 2021 related to this
arrangement.
Note 10. Commitments and Contingencies
Legal Proceedings
In the past, in the ordinary course of business,
the Company actively pursued legal remedies to enforce its intellectual property rights and to stop unauthorized use of our technology.
Other than ordinary routine litigation incidental to the business, we know of no material, active or pending legal proceedings against
us.
Risks and Uncertainties – COVID-19
Management continues to valuate the impact of
the COVID-19 pandemic on the industry and has concluded that while it is reasonably possible that the virus could have a negative effect
on the Company’s financial position, results of its operations and/or search for drug candidates, the specific impact is not readily
determinable as of the date of these consolidated financial statements. The COVID-19 pandemic has slowed down some drug
development efforts and has slowed the acquisition of new drugs. However, the impact of the pandemic and ensuing lockdowns are easing.
The process of drug development and further acquisitions is now continuing. The consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
Note 11. Subsequent Events
The Company evaluated events that have occurred
after the balance sheet date through the date the consolidated financial statements were issued. Based upon the evaluation and transactions,
the Company did not identify any other subsequent events that would have required adjustment or disclosure in the consolidated financial
statements.
11
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking
Statements
You
should read this discussion together with the Financial Statements, related Notes and other financial information included elsewhere
in this Form 10-Q. The following discussion contains assumptions, estimates and other forward-looking statements that involve a number
of risks and uncertainties. These risks could cause our actual results to differ materially from those anticipated in these forward-looking
statements. All references to “we,” “us,” “our” and the “Company” refer to Aikido Pharma
Inc., a Delaware corporation and its consolidated subsidiaries unless the context requires otherwise.
Overview
AIkido
Pharma Inc. was initially formed in 1967. Since 2017, the Company has operated as a biotechnology company with a diverse portfolio of
small-molecule anticancer and antiviral therapeutics in development. The Company’s pipeline consists of patented technology from
leading universities and researchers. We are currently in the process of developing our innovative therapeutic drug pipeline through
strong partnerships with world renowned educational institutions, including the University of Texas at Austin, the University of Maryland,
Baltimore and Wake Forest University. Our oncology therapeutics include treatments for pancreatic cancer, acute myeloid leukemia (AML)
and acute lymphoblastic leukemia (ALL). The Company is also developing a broad-spectrum antiviral platform, in which the lead compounds
have activity against multiple viruses including Influenza virus, Ebolavirus and Marburg virus, SARS-CoV, MERS-CoV, and SARS-CoV-2, the
cause of COVID-19.
As
a result of the Company’s biotechnology research and development and associated investments and acquisitions, our business portfolio
now focuses on the treatment of three different cancers and multiple types of viral infections. Our pancreatic drug candidate, DHA-dFdC,
developed at and licensed from the University of Texas at Austin, is a new compound that we hope will become the next generation of chemotherapy
treatment for advanced pancreatic cancer. DHA-dFdC overcomes tumor cell resistance to current chemotherapeutic drugs and is well tolerated
in preclinical toxicity tests. Preclinical studies have also indicated that DHA-dFdC inhibits pancreatic cancer cell growth (up to 100,000-fold
more potent that gemcitabine, a current standard therapy), targets pancreatic tumors and has demonstrated activities against other cancers,
including leukemia, lung and melanoma. Our AML and ALL compound, developed at the Wake Forest University, is a targeted therapeutic designed
to overcome multiple resistance mechanisms observed with the current standard of care.
Our
broad-spectrum antiviral platform was developed at the University of Maryland Baltimore (“UMB”), which granted the Company
an exclusive worldwide Master License Agreement (MLA”) to technology covered by three separate patent applications. The licensed
technology comprises broadly acting pan-viral inhibitory compounds targeting multiple viral pathogens. The technology was invented by
UMB scientists Drs. Matthew Frieman, Alexander MacKerell and Stuart Watson. The Company has also executed a Sponsored Research Agreement
with UMB to support the development of the technology under the direction of these inventors at UMB.
In
addition, we are constantly seeking to grow our pipeline of treatments in oncology indications. For example, in January 2021, the Company
invested in Convergent Therapeutics, Inc., which has exclusive rights to technology related to next-generation dual-action peptide receptor
radionuclide therapy (“PRRT”) for prostate cancer covered by multiple issued U.S. and foreign patents. Convergent is currently
conducting advanced human trials relating to prostate cancer treatments utilizing PRRT that targets the prostate-specific membrane antigen
(“PSMA”) present on prostate cancer cells. The technology was developed under the direction of Dr. Neil Bander, Professor
of Urologic Oncology at Weill Cornell Medicine. In addition, the Company was granted a license to four patent applications for the use
of psilocybin in cancer indications.
Additionally,
on January 6, 2021 the Company announced that it entered into an exclusive patent license agreement with Silo Pharma Inc. (“Silo
Pharma”) pursuant to which Silo Pharma granted the Company a worldwide exclusive, sublicensable, royalty-bearing license to certain
Silo Pharma owned provisional patent applications directed to the use of psilocybin in cancer treatment, and any patents issuing therefrom,
including all continuations, continuations-in-part, divisions, extensions, substitutions, reissues, re-examinations, and any applications
and all patents issuing from any applications and patents that claim domestic benefit or foreign priority to the provisional patent applications.
The license is for “Field of Use” (as defined in the exclusive patent license agreement) of “treatment of cancer and
symptoms caused by cancer, including but not limited to pain, nausea, neuroinflammation, brain and neural dysfunction, depression, seizures,
confusion, dizziness, numbness/tingling, dysfunction of the senses and all other symptoms that are caused by cancer of any type.”
12
Critical
Accounting Policies
Our
critical accounting policies are disclosed in our annual report on Form 10K for the year ended December 31, 2020 and there have been
no material changes to such policy or estimates during the six months ended June 30, 2021.
Recently
Issued Accounting Pronouncements
See
Note 3 to the condensed consolidated financial statements for a discussion of recent accounting standards.
Results
of Operations
Three
months ended June 30, 2021 compared to three months ended June 30, 2020
During the three months ended June 30, 2021,
we incurred a loss from operations of approximately $2.8 million, as compared to $1.8 million during the comparable prior year period.
The increase in loss was primarily attributed to $1.3 million increase in in general and administrative expenses, partially offset by
$0.4 million decrease research and development expense and $11,000 decrease in research and development expense related with license
acquisition.
During
the three months ended June 30, 2021, other income was approximately $1.4 million as compared to other expense
of approximately $0.5 million during the comparable prior year period. The net loss per share decreased from a decrease in net operating
losses and a significant increase in the number of shares outstanding. The decrease in other expense was primarily attributed to a $1.2
million lower loss in the change in fair value of investment in Hoth and $0.7 million increase in gains on marketable securities.
The
Company experienced very little or no revenue in the last two years and we don’t expect any revenue until a biotechnology product
is fully developed which may not occur for many years.
Six
months ended June 30, 2021 compared to six months ended June 30, 2020
During the six months ended June 30, 2021, we
incurred a loss from operations of approximately $5.1 million, as compared to a loss of $4.2 million during the comparable prior year
period. The increase in loss was primarily attributed to $1.2 million increase in general and administrative expenses, and $12,000 increase
in research and development expense related to the license acquisition, partially offset by $0.4 million decrease in research and development
expense.
During
the six months ended June 30, 2021, other expense was approximately $0.2 million as compared to approximately $6.5 million during the
comparable prior year period. The decrease in other expense was primarily attributed to a $5.8 million lower loss in the change in fair
value of investment in Hoth and $0.2 million increase in gains on marketable securities. The net loss per share decreased from a decrease
in net operating losses and a significant increase in the number of shares outstanding.
The
Company experienced very little or no revenue in the last two years and we don’t expect any revenue until a biotechnology product
is fully developed which may not occur for many years.
Liquidity
and Capital Resources
We
continue to incur ongoing administrative and other expenses, including public company expenses, in excess of corresponding (non-financing
related) revenue. We do not expect to incur revenue until any of our biotechnology products are fully developed. While we continue to
implement our business strategy, we intend to finance our activities through managing current cash on hand from our past equity offerings.
During
the six months of 2021, the Company consummated a public offering of 53,905,927 shares of common stock (including the underwriter overallotment).
The Company received net proceeds of approximately $78.0 million after deducting underwriting discounts and commissions and estimated
offering expenses payable by the Company. Therefore, the Company has adequate cash to fund its operations for at least the next twelve
months.
Moving
forward, the Company intends to manage its cash through an investment committee focused on asset preservation and reasonable risk allocation.
Further, the Company intends to grow its drug platform through additional licensing efforts that are similar to those the Company has
already entered into and disclosed. In addition, the Company is seeking partnerships with academic institutions and private enterprise
to find, fund and advance new drug compounds that can be brought to commercialization.
13
Management
continues to evaluate the impact of the COVID-19 pandemic on the industry and has concluded that while it is reasonably possible that
the virus could have a negative effect on the Company’s consolidated financial position, results of its consolidated operations
and/or search for drug candidates, the specific impact is not readily determinable as of the date of these consolidated financial statements.
The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Cash Flows from Operating Activities -
For the six months ended June 30, 2021 and 2020, net cash used in operations was approximately $2.7 million and $2.4 million, respectively.
The cash used in operating activities for the six months ended June 30, 2021 primarily resulted from a net loss of $5.3 million and $1.1
million realized gain on marketable securities, and partially offset by $1.4 million unrealized loss on marketable securities and $1.1
million research and development expense related with license acquired. The cash used in operating activities for the six months ended
June 30, 2020 primarily resulted from a net loss of $10.6 million, and partially offset by the reduction in fair value of investment of
$6.7 million and $1.1 million research and development expense related with license required.
Cash Flows from Investing Activities -
For the six months ended June 30, 2021 and 2020, net cash used in investing activities was approximately $70.4 million and $26.5 million,
respectively. The cash used in investing activities for the six months ended June 30, 2021 primarily resulted from our purchase of marketable
securities of $86.5 million, funds to deposit accounts of $4.5 million (net of fee) and purchase of convertible note of $2.0 million,
partially offset by our sale of marketable securities of $23.2 million since we invest excess cash into marketable securities until additional
cash is needed. The cash used in investing activities for the six months ended June 30, 2020 primarily resulted from our purchase of marketable
securities of $78.0 million and research and development expense related with license acquired of $1.1 million, partially offset by our
purchase of marketable securities of $52.2 million since we invest excess cash into marketable securities until additional cash is needed.
Cash
Flows from Financing Activities - Cash provided by financing activities for the six months ended June 30, 2021 was $78.1 million,
which reflects the net proceeds of $78.0 million from investors in exchange of issuance of common stock and warrants and net proceeds
of $84,000 from the exercise of common warrants. Cash provided by financing activities for the six months ended June 30, 2020 was $31.6
million, which reflects the net proceeds of $6.6 from investors in exchange of issuance of common stock, common warrants and prefunded
warrants, net proceeds of $17.8 from investors in exchange of issuance of common stock, and net proceeds of $7.2 million from the exercise
of common warrants and prefunded warrants
Off-balance
sheet arrangements.
None.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
Not
required for smaller reporting companies.
Item
4. Controls and Procedures
Disclosure
Controls and Procedures
We
maintain “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), that are designed to ensure that information required to be disclosed
by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods
specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management,
including our Chief Executive Officer, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure
controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can
provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally,
in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit
relationship of possible disclosure controls and procedures.
The
design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events,
and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
With
respect to the quarter ended June 30, 2021, under the supervision and with the participation of our management, we conducted an evaluation
of the effectiveness of the design and operations of our disclosure controls and procedures. Based upon this evaluation, our Chief Executive
Officer has concluded that our disclosure controls and procedures were not effective as of June 30, 2021 due to the material weaknesses
in our internal controls over financial reporting. We have a lack of segregation of duties, and a lack of controls in place to ensure
that all material transactions and developments impacting the financial statements are reflected.
C hanges
in Internal Control over Financial Reporting:
There
were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
that occurred during the fiscal quarter ended June 30, 2021 which have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
14
Part
II. Other Information
Item
1. Legal Proceedings
In
the past, in the ordinary course of business, we actively pursued legal remedies to enforce our intellectual property rights and to stop
unauthorized use of our technology. Other than ordinary routine litigation incidental to the business, we know of no material, active
or pending legal proceedings against us.
Item
1A. Risk Factors
There
have been no material changes in our risk factors from those disclosed in our Annual Report on Form 10-K for the fiscal year ended December
31, 2020 and in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item
6. Exhibits
31.1
Certification of Principal Executive Officer and Principal Financial Officer of AIkido Pharma Inc. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1
Certification of Principal Executive Officer and Principal Financial Officer of AIkido Pharma Inc. pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema Document.
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
15
Signatures
Pursuant
to the requirements of the Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
Aikido
Pharma Inc.
(Registrant)
Date:
August 11, 2021
By:
/s/
Anthony Hayes
Anthony
Hayes
Chief
Executive Officer
(Principal
Executive Officer,
Principal Financial Officer and
Principal Accounting Officer)
16
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.