Item 2. Management’s Discussion and Analysis
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.
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