The following discussion and analysis of our unaudited condensed consolidated
financial condition and results of operations should be read in conjunction with
the audited consolidated financial statements and accompanying notes included in
the Company's Annual Report on Form 10-K for the year ended December 31, 2020,
as filed with the Securities and Exchange Commission ("SEC") on March 29, 2021,
as amended on April 29, 2021 (collectively, the "Form 10-K"), and certain other
reports filed with the SEC as may be set forth below.

Forward Looking Statements



This quarterly report on Form 10-Q ("Quarterly Report") and other reports filed
by Scopus BioPharma Inc. (the "Company") from time to time with the SEC
(collectively, the "Filings") contain or may contain forward-looking statements
and information that are based upon beliefs of, and information currently
available to, the Company's management, as well as estimates and assumptions
made by Company's management. Readers are cautioned not to place undue reliance
on these forward-looking statements, which are only predictions and speak only
as of the date hereof. When used in the Filings, the words "may", "will",
"anticipate", "believe", "estimate", "expect", "future", "intend", "plan", or
the negative of these terms and similar expressions as they relate to the
Company or the Company's management are intended to identify forward-looking
statements. Such statements reflect the current view of the Company with respect
to future events and we caution you that these statements are not guarantees of
future performance or events and are subject to risks, assumptions, and other
factors. Should one or more of these risks or uncertainties materialize, or
should the underlying assumptions prove incorrect, actual results may differ
significantly from those anticipated, believed, estimated, expected, intended,
or planned. Unless otherwise stated in this Quarterly Report, "we", "us", "our",
"Company", "Scopus" and "Scopus BioPharma" refer to Scopus BioPharma Inc.

Although the Company believes that the expectations reflected in the
forward-looking statements are reasonable, the Company cannot guarantee future
results, levels of activity, performance, or achievements. Except as required by
applicable law, including the securities laws of the United States, the Company
does not intend to update any of the forward-looking statements to conform these
statements to actual results.

Our unaudited condensed consolidated financial statements are prepared in
accordance with accounting principles generally accepted in the United States
("GAAP"). These accounting principles require us to make certain estimates,
judgments and assumptions. We believe that the estimates, judgments and
assumptions upon which we rely are reasonable based upon information available
to us at the time that these estimates, judgments and assumptions are made.
These estimates, judgments and assumptions can affect the reported amounts of
assets and liabilities as of the date of the financial statements, as well as
the reported amounts of revenues and expenses during the periods presented. Our
unaudited condensed consolidated financial statements would be affected to the
extent there are material differences between these estimates and actual
results. In many cases, the accounting treatment of a particular transaction is
specifically dictated by GAAP and does not require management's judgment in its
application. There are also areas in which management's judgment in selecting
any available alternative would not produce a materially different result. The
following discussion should be read in conjunction with our financial statements
and notes thereto appearing elsewhere in this Quarterly Report.

Overview



We are a clinical-stage biopharmaceutical company developing transformational
therapeutics for serious diseases with significant unmet medical needs. Our
mission is to improve patient outcomes and save lives. To achieve our mission,
we are capitalizing on groundbreaking scientific and medical discoveries at some
of the world's foremost research and academic institutions.

On September 2, 2021, we announced the launch of Duet Therapeutics ("Duet").
Duet integrates the management and clinical development of the immunotherapy
assets of Scopus and Olimmune (the "Duet Platform"). Olimmune was acquired

by
Scopus in June 2021.

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The Duet Platform is comprised of three distinctive, complementary CpG-STAT3
inhibitors:


?  RNA silencing         CpG-STAT3siRNA ("DUET-01")

?  Antisense             CpG-STAT3ASO   ("DUET-02")

?  DNA-binding inhibitor CpG-STAT3decoy ("DUET-03")




Our lead development program, DUET-01, is a novel, targeted immunotherapy for
the treatment of multiple cancers. We have partnered with City of Hope ("COH")
for DUET-01, which is a TRL9 agonist and STAT3 inhibitor. Pre-clinical testing
at COH was designed to determine whether DUET-01 would reduce growth and
metastasis of various pre-clinical tumor models, including melanoma, and colon
and bladder cancers, as well as leukemia and lymphoma. Based upon such testing,
an IND for DUET-01 for B-cell non-Hodgkin lymphoma ("B-cell lymphoma) was filed
with and subsequently approved by the United States Food and Drug Administration
("FDA") in April 2021 and May 2021, respectively. A first-in-human Phase 1
clinical trial for B-cell lymphoma is currently seeking to enroll patients.

Duet expects to file two INDs for DUET-02 in Q4 2022 in genitourinary and head &
neck cancers, with Phase 1 clinical trials beginning in Q1 2023 in the United
States. Duet is also evaluating combination therapies with checkpoint inhibitors
for its CpG-STAT3 inhibitors.

Our pipeline of drug candidates also includes MRI-1867, a
peripherally-restricted, dual-action cannabinoid-1 ("CB1") receptor inverse
agonist and inhibitor of inducible nitric oxide synthase ("iNOS"). We have
partnered with the National Institutes of Health ("NIH") for MRI-1867 and are
initially targeting systemic sclerosis ("SSc"). Over-activation of CB1 and iNOS
has been implicated in the pathophysiology of SSc, which includes fibrosis of
the skin, lung, kidney, heart, and the gastrointestinal tract. We are also
partnered with The Hebrew University of Jerusalem ("Hebrew University") on
several additional research and development programs. These programs relate to a
proprietary opioid-sparing anesthetic and synthesis of novel compounds and new
chemical entities ("NCEs"). We are continually monitoring the impact of the
on-going global pandemic on us. Until we are able to gain greater visibility as
to the impact of the evolving pandemic, including emerging variants and
responses thereto, we intend to commit greater resources to our existing and
future programs in the United States and may reduce resources for development
programs outside the United States. Moreover, with respect to all of our
programs, we continually evaluate them for feasibility and potential likelihood
of success generally and relative to the cost of development, time for
enrollment and development, patent life and market exclusivity. As such, we may
seek to accelerate programs or terminate programs based on these analyses, our
financial wherewithal, market dynamics and other factors.

We have devoted substantially all of our resources to our development efforts
relating to our drug candidates, including sponsoring research with
world-renowned academic and medical research institutions, preparing to
implement a Phase 1 clinical trial for B-cell lymphoma at COH, pursuing
additional pre-clinical studies, securing and protecting our licensed
intellectual property, and providing general and administrative support for
these operations. We do not have any products approved for sale and have not
generated any revenue from product sales. From inception (April 18, 2017) until
September 30, 2021, we have funded our operations primarily through the issuance
of equity and debt securities.

We have incurred net losses in each year since our inception. As of September
30, 2021, we had an accumulated deficit of $34,936,289. Substantially all of our
net losses resulted from costs incurred in connection with our research and
development programs and from general and administrative costs associated with
our operations.

We expect to continue to incur significant expenses and increasing operating
losses for at least the next several years. We anticipate that all our expenses
will increase substantially as we:

? continue our research and development efforts;

? contract with third-party research organizations to manage our clinical and

pre-clinical trials for our drug candidates;

? outsource the manufacturing of our drug candidates for clinical trials and

pre-clinical testing;

? seek to obtain regulatory approvals for our drug candidates;




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  Table of Contents

? maintain, expand, and protect our intellectual property portfolio;

? add operational, financial and management information systems and personnel to

support our research and development and regulatory efforts; and

? operate as a public company, including involvement in legal proceedings.


We do not expect to generate revenue from product sales unless and until we
successfully complete development and obtain marketing approval for one or more
of our drug candidates, which we expect will take a number of years and is
subject to significant uncertainty. Accordingly, we will need to raise
additional capital prior to the commercialization of any of our current or
future drug candidates. Until such time, if ever, as we can generate substantial
revenue from product sales, we expect to finance our operating activities
through equity and debt offerings. We may also raise capital through government
or other third-party funding and grants, collaborations and development
agreements, strategic alliances, and licensing arrangements. However, we may be
unable to raise additional funds or enter into such other arrangements when
needed on favorable terms or at all. Our failure to raise capital or enter into
such other arrangements as and when needed would have a negative impact on our
financial condition and our ability to develop our drug candidates.

Critical Accounting Policies and Estimates



Our management's discussion and analysis of our financial condition and results
of operations is based on our condensed consolidated financial statements, which
we have prepared in accordance with GAAP. The preparation of these condensed
consolidated financial statements requires us to make estimates and assumptions
that affect the reported amounts of assets and liabilities and the disclosure of
contingent assets and liabilities at the date of the financial statements, as
well as the reported revenues and expenses during the reporting periods. We
evaluate these estimates and judgments on an ongoing basis. We base our
estimates on historical experience and on various other factors that we believe
are reasonable under the circumstances, the results of which form the basis for
making judgments about the carrying value of assets and liabilities that are not
readily apparent from other sources. Our actual results may differ from these
estimates under different assumptions or conditions.

Our significant accounting policies are fully described in Note 2 to our
consolidated financial statements appearing in our Form 10-K. We believe that
the accounting policies are critical for fully understanding and evaluating our
financial condition and results of operations.

JOBS Act



On April 5, 2012, the Jumpstart Our Business Startups Act of 2012, or the JOBS
Act, was enacted. Under the JOBS Act, emerging growth companies can delay
adopting new or revised accounting standards issued after the enactment of the
JOBS Act until such time as those standards apply to private companies. We have
irrevocably elected to avail ourselves of this exemption from new or revised
accounting standards, and, therefore, will not be subject to the same new or
revised accounting standards as public companies that are not emerging growth
companies. As a result of this election, our financial statements may not be
comparable to companies that are not emerging growth companies.

Subject to certain conditions set forth in the JOBS Act, as an "emerging growth
company," we intend to rely on certain of these exemptions and reduced reporting
requirements provided by the JOBS Act 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 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 billion or more; (ii) the last day of our
fiscal year following the fifth anniversary of the date of the completion of our
initial public offering; (iii) the date on which we have issued more than $1
billion in non-convertible 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.

                                       23

  Table of Contents

Results of Operations

Three Months Ended September 30, 2021 Versus Three Months Ended September 30, 2020

The following table summarizes our results of operations for the three months ended September 30, 2021 and 2020, respectively:






                                            Three Months Ended
                                              September 30,
                                          2021             2020             Change        % Change
Operating Expenses:
General and Administrative            $   2,682,310    $     806,045    $    1,876,265       232.8 %
Research and Development                     77,527           69,421             8,106        11.7 %
Loss from Operations                    (2,759,837)        (875,466)       (1,884,371)       215.2 %
Other income (expense):
Interest expense                          (110,669)        (284,520)           173,851        61.1 %
Change in fair value of common
stock warrant liability                   1,470,163                -         1,470,163       100.0 %
Total other income (expense)              1,359,494        (284,520)         1,644,014       577.8 %
Net Loss                              $ (1,400,343)    $ (1,159,986)    $      240,357        20.7 %




Our net losses were $1,400,343 and $1,159,986 for the three months ended
September 30, 2021 and 2020, respectively, an increase of $240,357 or 20.7%. We
anticipate our net losses will continue as we advance our research and drug
development activities and incur additional general and administrative expenses
to meet the needs of our business.

Revenue



We did not have any revenue during the three months ended September 30, 2021 or
2020. Our ability to generate product revenues in the future will depend almost
entirely on our ability to successfully develop, obtain regulatory approval for,
and then successfully commercialize a drug candidate.

Operating Expenses

General and Administrative Expenses



General and administrative expenses consist primarily of compensation and
benefits to our personnel, including the costs related to our management
services agreements, directors and scientific and senior advisors; professional
fees and services, including accounting and legal services; and expenses related
to obtaining and protecting our intellectual property. We incurred general and
administrative expenses in the three months ended September 30, 2021 and 2020 of
$2,682,310 and $806,045, respectively, an increase of $1,876,265 or 232.8%. This
increase in our general and administrative expenses is primarily attributable to
increases in fees and stock compensation expenses totaling $183,712 associated
with our directors and scientific and senior advisors, most of whom joined the
company during the second half of 2020 and did not have a significant impact on
our financial results during the three months ended September 30, 2020 and
$1,929,949 of certain professional fees and public company costs related to
operating as a public company (including increased costs for investor relations,
directors and officers insurance and to comply with corporate governance, legal
proceedings, internal controls and similar requirements applicable to public
companies), partially offset by a decrease in employee compensation expenses of
$237,396 due to the reversal of executive bonuses, all of which have increased
in 2021 following the completion of our IPO in December 2020. Included in
professional fees and public company costs are legal fees and expenses incurred
in connection with legal services provided to the board of directors and certain
committees thereof, including relating to former officers and directors. See
Part II-Other Information, our Annual Report on Form 10-K, the Schedule 13D
filed with the SEC by a former director on April 7, 2021, our Current Reports on
Form 8-K filed with the SEC on July 9, 2021 and September 30, 2021 and the
materials filed by us on Schedule 14A for additional information concerning

such
matters.

                                       24

  Table of Contents

Research and Development and Expenses



We recognize research and development expenses as they are incurred. Our
research and development expenses consist of the costs associated with obtaining
our intellectual property that are classified as in-process research and
development and fees incurred under our agreements with COH, the NIH and Hebrew
University, including the expenses associated with securities issued in
connection with such agreements, as applicable. For the three months ended
September 30, 2021 and 2020, we incurred research and development expenses of
$77,527 and $69,421, respectively, an increase of $8,106 or 11.7%. These
expenses were incurred in connection with the preclinical work for the Duet
Platform by COH. We anticipate that our research and development expenses,
exclusive of any in-process research and development relating to our
acquisitions, will increase for the foreseeable future as we continue the
clinical development of DUET-01, DUET-02, DUET-03 and MRI-1867, and to further
advance the development of our other research and development programs, subject
to the availability of additional funding.

Other Income (Expense)



Other income (expense) consists of changes in the fair value of a warrant
liability, as well as interest expense on our Convertible Notes. Other income
(expense) was $1,359,494 and $(284,520) for the three months ended September 30,
2021 and 2020, respectively, an increase of $1,644,014 or 577.8%. Other income
related to the change in fair value of warrant liability was $1,470,163 for the
three months ended September 30, 2021. There was no income or expense related to
the warrant liability during the three months ended September 30, 2020. This
income during the three months ended September 30, 2021 is associated with the
decrease of a liability related to certain warrants issued in August and
September 2020 which were reclassified from equity to warrant liability on June
25, 2021. Until their reclassification into equity on July 31, 2021, we were
required to revalue warrants classified on our balance sheet as a liability at
the end of each reporting period and reflect a gain or loss from the change in
fair value in the period in which the change occurred. We calculated the fair
value of such warrants using a Monte Carlo daily price simulation. Interest
expense was $110,669 and $284,520 for the three months ended September 30, 2021
and 2020, respectively, a decrease of $173,851 or 61.1%. This decrease is
attributable to the conversion of the Convertible Notes into the W Warrants on
July 31, 2021, with the Convertible Notes being outstanding during only one
month during the three months ended September 30, 2021 as compared to the entire
three months ended September 30, 2020.

Nine Months Ended September 30, 2021 Versus Nine Months Ended September 30, 2020

The following table summarizes our results of operations for the nine months ended September 30, 2021 and 2020, respectively:






                                             Nine Months Ended
                                               September 30,
                                           2021             2020             Change         % Change
Operating Expenses:
General and Administrative            $    6,228,103    $   2,087,423    $    4,140,680         198.4 %
Research and Development                  14,887,657        7,354,295         7,533,362         102.4 %
Loss from Operations                    (21,115,760)      (9,441,718)      (11,674,042)         123.6 %
Other income (expense):
Interest expense                           (774,679)        (369,665)         (405,014)         109.6 %
Change in fair value of common
stock warrant liability                    1,455,889                -         1,455,889         100.0 %
Total other income (expense)                 681,210        (369,665)         1,050,875         284.3 %
Net Loss                              $ (20,434,550)    $ (9,811,383)    $   10,623,167         108.3 %




Our net losses were $20,434,550 and $9,811,383 for the nine months ended
September 30, 2021 and 2020, respectively, an increase of $10,623,167 or 108.3%.
We anticipate our net losses will continue as we advance our research and drug
development activities and incur additional general and administrative expenses
to meet the needs of our business.

Revenue


We did not have any revenue during the nine months ended September 30, 2021 or
2020. Our ability to generate product revenues in the future will depend almost
entirely on our ability to successfully develop, obtain regulatory approval for,
and then successfully commercialize a drug candidate.

                                       25

  Table of Contents

Operating Expenses

General and Administrative Expenses



General and administrative expenses consist primarily of compensation and
benefits to our personnel, including the costs related to our employees,
management services agreements, directors and scientific and senior advisors;
professional fees and services, including accounting and legal services; and
expenses related to obtaining and protecting our intellectual property. We
incurred general and administrative expenses in the nine months ended September
30, 2021 and 2020 of $6,228,103 and $2,087,423, respectively, an increase of
$4,140,680 or 198.4%. This increase in our general and administrative expenses
is primarily attributable to increases in fees and stock compensation expenses
totaling $615,784 associated with our directors and scientific and senior
advisors, most of whom joined the company during the second half of 2020 and did
not have a significant impact on our financial results during the nine months
ended September 30, 2020 and $3,715,329 of certain professional fees and public
company costs related to operating as a public company (including increased
costs for investor relations, directors and officers insurance and to comply
with corporate governance, legal proceedings, internal controls and similar
requirements applicable to public companies), partially offset by a decrease in
employee compensation expenses of $192,918 due to the reversal of executive
bonuses, all of which have increased in 2021 following the completion of our IPO
in December 2020. Included in professional fees and public company costs are
legal fees and expenses incurred in connection with legal services provided to
the board of directors and certain committees thereof, including relating to
former officers and directors. See Part II-Other Information, Item 1. Legal
Proceedings, our Annual Report on Form 10-K, the Schedule 13D filed with the SEC
by a former director on April 7, 2021, our Current Reports on Form 8-K filed
with the SEC on July 9, 2021 and September 30, 2021 and the materials filed by
us on Schedule 14A for additional information concerning such matters.

Research and Development and Expenses



We recognize research and development expenses as they are incurred. Our
research and development expenses consist of the costs associated with our
acquisition of intellectual property that are classified as in-process research
and development and fees incurred under our agreements with COH, the NIH and
Hebrew University, including the expenses associated with securities issued in
connection with such agreements, as applicable. For the nine months ended
September 30, 2021 and 2020, we incurred research and development expenses of
$14,887,657 and $7,354,295, respectively, an increase of $7,533,362 or 102.4%.
These expenses increased primarily as a result of the costs related to our
acquisition of Olimmune, the upfront costs under the Olimmune Licenses and costs
associated with the filing of the IND and preparation for the Phase 1 clinical
trial for DUET-01. Expenses relating to the acquisition of Olimmune, the
Olimmune Licenses and the DUET-01 IND and Phase I clinical trial were
$6,998,530, $1,081,622 and $1,503,277, respectively. These new expenses were
offset by a $1,995,702 decrease in in-process research and development costs
related to our acquisition of Bioscience Oncology and DUET-01in 2020. We
anticipate that our research and development expenses, exclusive of any
in-process research and development relating to our acquisitions, will increase
for the foreseeable future as we continue the clinical development of DUET-01,
DUET-02, DUET-03 and MRI-1867, and to further advance the development of our
other research and development programs, subject to the availability of
additional funding.

Other Income (Expense)



Other income (expense) consists of changes in the fair value of a warrant
liability, as well as interest expense on our Convertible Notes. Other income
(expense) was $681,210 and $(369,665) for the nine months ended September 30,
2021 and 2020, respectively, an increase of $1,050,875 or 284.3%. Other income
related to the change in fair value of warrant liability was $1,455,889 for the
nine months ended September 30, 2021. There was no income or expense related to
the warrant liability during the nine months ended September 30, 2020. This
income during the nine months ended September 30, 2021 is associated with the
decrease of a liability related to certain warrants issued in August and
September 2020 which were reclassified from equity to warrant liability on June
25, 2021. Until their reclassification into equity on July 31, 2021, we were
required to revalue warrants classified on our balance sheet as a liability at
the end of each reporting period and reflect a gain or loss from the change in
fair value in the period in which the change occurred. We calculated the fair
value of such warrants using a Monte Carlo daily price simulation. Interest
expense was $774,679 and $369,665 for the nine months ended September 30, 2021
and 2020, respectively, an increase of $405,014 or 109.6%. This increase is
attributable to an increase in the principal amount of our Convertible Notes
outstanding during the nine months ended September 30, 2021 (until their partial
repayment in cash and partial conversion into the W Warrants at the Maturity
Date on July 31, 2021), versus during the nine months ended September 30, 2020.

                                       26

  Table of Contents

Liquidity and Capital Resources



Since April 18, 2017 (inception), we have incurred losses and, as of September
30, 2021, we had an accumulated deficit of $34,936,289. From inception through
September 30, 2021, we have funded our operations principally through the sale
of equity and debt securities totaling $19.4 million in the aggregate. As of
September 30, 2021, we had cash of $3,632,080 and net working capital of
$1,791,196, compared to cash of $1,832,100 and net working capital of
$(1,833,557) as of December 31, 2020.

For the nine months ended September 30, 2021, we used $7,276,008 of cash in
operations, which was attributable to our net loss of $20,434,550 and changes in
operating assets and liabilities of $759,142, offset by $12,399,400 of non-cash
expenses. For the nine months ended September 30, 2020, we used $1,605,996 of
cash in operations, which was attributable to our net loss of $9,811,383 and
changes in operating assets and liabilities of $1,367,024, offset by non-cash
expenses of $6,838,362.

In July 2021, $3,084,875 of outstanding principal and accrued interest under our Convertible Notes was converted into 6,169,771 W Warrants. The balance of $129,538 of outstanding principal and accrued interest was forfeited. Accordingly, we had no further obligations under our Convertible Notes.

The Company is party to litigation in several matters as of the date hereof.


 Litigation is highly unpredictable and the costs of litigation, including legal
fees and expenses, and the possible liabilities, including monetary damages, to
which the Company could become subject could be significant. Any such
liabilities could have a material adverse effect on the Company. The Company has
not recorded any liability as of September 30, 2021 because a potential loss is
not probable or reasonably estimable given the preliminary nature of the various
proceedings.  Subsequent to September 30, 2021, the Company has continued to
commit significant capital resources relating to on-going litigation.  The
Company's existing capital resources will not be sufficient to fully implement
its business plan, including the development of its drug candidates, while also
continuing to be subject to or pursuing on-going litigation, especially on an
expedited basis. The Company will require additional financing and there can be
no assurance that any such financing will be available on satisfactory terms, or
at all. Further, there can be no assurance that the absence of any additional
financing, as necessary, will not have a material adverse effect on the Company.
See "Note 8 - Commitments and Contingencies - Legal Proceedings" and "Part II -
Other Information; Item 1. Legal Proceedings."

Future Funding Requirements



We have not generated any revenue. We do not know when, or if, we will generate
any revenue from product sales. We do not expect to generate significant revenue
from product sales unless and until we obtain regulatory approval of and
commercialize any of our drug candidates. We anticipate that we will continue to
incur losses for at least the next several years. We expect that our research
and development costs and general and administrative expenses will continue to
increase as we advance our drug candidates through the pre-clinical and clinical
development processes and hire additional personnel and/or consultants to
support such activities. In addition, subject to obtaining regulatory approval
of any of our drug candidates, we expect to incur significant commercialization
expenses for product sales, marketing, manufacturing and distribution.

As a result, we anticipate that we will need substantial additional funding in
connection with our continuing operations to fund future clinical trials and
pre-clinical testing for our drug candidates, general and administrative costs
and public company and other expenses, including potential indemnification
obligations and legal fees (primarily related to litigation). See Part II-Other
Information, Item 1. Legal Proceedings, our Annual Report on Form 10-K, the
Schedule 13D filed with the SEC by a former director on April 7, 2021, our
Current Reports on Form 8-K filed with the SEC on July 9, 2021 and September 30,
2021 and the materials filed by us on Schedule 14A for additional information
concerning such matters. We expect to finance our cash needs primarily through
the sale of our debt and equity securities. We may also raise capital through
government or other third-party funding and grants, collaborations and
development agreements, strategic alliances and licensing arrangements. Because
of the numerous risks and uncertainties associated with the development and
commercialization of our drug candidates, we are unable to estimate the amounts
of additional capital outlays and operating expenditures necessary to complete
the development of our drug candidates.

Our future capital requirements will depend on many factors, including:

the progress, costs, results and timing of our drug candidates' future clinical

? studies and future pre-clinical trials, and the clinical development of our


   drug candidates for other potential indications beyond their initial target
   indications;


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  Table of Contents

the willingness of the FDA and the EMA to accept our future drug candidate

? clinical trials, as well as our other completed and planned clinical and

pre-clinical studies and other work, as the basis for review and approval of

our drug candidates;

? the outcome, costs and timing of seeking and obtaining FDA, EMA and any other

regulatory approvals;

? the number and characteristics of drug candidates that we pursue, including our

drug candidates in future pre-clinical development;

? the ability of our drug candidates to progress through clinical development

successfully;

? our need to expand our research and development activities;

? the costs associated with securing and establishing commercialization and

manufacturing capabilities;

? the costs of acquiring, licensing or investing in businesses, products, drug

candidates and technologies;

our ability to maintain, expand and defend the scope of our licensed

intellectual property portfolio, including the amount and timing of any

? payments we may be required to make, or that we may receive, in connection with

the licensing, filing, prosecution, defense and enforcement of any patents or

other intellectual property rights;

? our need and ability to hire additional management and scientific and medical

personnel;

? the effect of competing technological and market developments;

? our need to implement additional internal systems and infrastructure, including

financial and reporting systems;

? the costs associated with ongoing, and possibly future, legal proceeds and

related indemnification obligations;

? the duration and spread of the COVID-19 pandemic, and associated operational

delays and disruptions and increased costs and expenses; and

? the economic and other terms, timing and success of any collaboration,

licensing or other arrangements into which we may enter in the future.




Until such time, if ever, as we can generate substantial revenue from product
sales, we expect to finance our cash needs through a combination of debt
financings and equity offerings, government or other third-party funding,
marketing and distribution arrangements and other collaborations, strategic
alliances and licensing arrangements. To the extent that we raise additional
capital through the sale of debt and equity securities, the ownership interests
of our common stockholders will be diluted, and the terms of these securities
may include liquidation or other preferences that adversely affect the rights of
our common stockholders. Debt financing, if available, may involve agreements
that include covenants limiting or restricting our ability to take specific
actions, such as incurring additional debt, making capital expenditures or
declaring dividends. If we raise additional funds through government or other
third-party funding, marketing and distribution arrangements or other
collaborations, strategic alliances or licensing arrangements with third
parties, we may have to relinquish valuable rights to our technologies, future
revenue streams, research programs or drug candidates or to grant licenses on
terms that may not be favorable to us.

We have considered the spread of the COVID-19 coronavirus outbreak, which the
World Health Organization has declared a "Public Health Emergency of
International Concern." The COVID-19 outbreak is disrupting supply chains and
affecting production and sales across a range of industries. The extent of the
impact of COVID-19 on our operational and financial performance will depend on
certain developments, including the duration and spread of the pandemic and its
impact on our employees and vendors, and our ability to raise capital, all of
which are uncertain and cannot be predicted. At this point, the extent to which
COVID-19 may impact our financial condition or results of operations remains
uncertain.

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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 under SEC rules.

Recent Accounting Pronouncements



The Company is an "emerging growth company", as defined in the Jumpstart Our
Business Startups Act of 2012 (the "JOBS Act"). Under the JOBS Act, emerging
growth companies can delay adopting new or revised accounting standards issued
subsequent to the enactment of the JOBS Act until such time as those standards
apply to private companies. The Company has irrevocably elected to avail itself
of this exemption from new or revised accounting standards, and, therefore, will
not be subject to the same new or revised accounting standards as public
companies that are not emerging growth companies.

We have reviewed recent accounting pronouncements and concluded they are either not applicable to the business or no material effect is expected on the condensed consolidated financial statements as a result of future adoption.

Effect of Inflation and Changes in Prices

We do not believe that inflation and changes in prices will have a material effect on our operations.

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