ALLARITY THERAPEUTICS, INC. Management’s Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q)

You should read the following discussion and analysis of our financial condition
and plan of operations together with our condensed consolidated financial
statements and the related notes appearing elsewhere in this Quarterly Report.
In addition to historical information, this discussion and analysis contains
forward-looking statements that involve risks, uncertainties and assumptions.
Our actual results may differ materially from the plans, intentions,
expectations and other forward-looking statements included in the discussion
below. Factors that could cause or contribute to such differences include, but
are not limited to, those identified below, and those factors discussed in the
section titled "Risk Factors" of our Annual Report on Form 10-K, filed with
the
SEC on May 17, 2022.



Overview



We are a biopharmaceutical company focused on discovering and developing highly
targeted anti-cancer drug candidates. Using its Drug Response Predictor (DRP®)
platform, the Company identifies the value in drug assets that have otherwise
been discontinued by identifying patient populations where these drugs are
active. The Company's three lead drug candidates are: the tyrosine kinase
inhibitor (TKI) dovitinib, the poly-ADP-ribose polymerase (PARP) inhibitor
stenoparib, and the microtubule inhibitor agent IXEMPRA.



Recent Business Developments


On August 2, 2022the Company announced that its board of directors (the “Board”) has ordered a realignment of the Company’s oncology pipeline strategy away from the development of monotherapies toward the development of more promising and clinically relevant combination therapies.



Following a lengthy and in-depth analysis of current pipeline opportunities,
clinical/commercial/ regulatory risks, development costs and timelines, expected
availability of funding, and in consultation with our senior management, its
Scientific Advisory Board (SAB), and external experts, the Board concluded that
refocusing the Company's pipeline to development of combination therapies will
accomplish the following:


? Align with the ongoing shift in the standard of care away from cancer therapy

Monotherapies to combination therapies, which are increasingly being promoted

market opportunities and which have shown a dramatic increase in patient numbers

To use.

? Strengthening the company’s ability to attract additional funds

institutional life science investors in support of the

the clinical development activities and the future success of the company.

? Significantly expand the company’s opportunities for future commercial activities

Partnering with larger pharmaceutical companies to maximize value

Pipeline assets and DRP® platform technology.

? Improving the Company’s likelihood of clinical and commercial success

   pipeline assets.



The Board's decision also considers feedback that the Company received from the
U.S. Food and Drug Administration (FDA). We submitted an NDA with the FDA on
December 21, 2021, for the third line treatment of metastatic renal cell
carcinoma (mRCC or kidney cancer) in patients selected by our Dovitinib-DRP®
companion diagnostic. Prior to submission of the NDA, we submitted a Pre-Market
Approval (PMA) application to the FDA for approval of our dovitinib-specific
DRP® companion diagnostic for use to select and treat patients likely to respond
to dovitinib. On February 15, 2022, we received Refusal to File (RTF) letters
for both our dovitinib NDA and our DRP®-Dovitinib companion diagnostic PMA. The
FDA has asserted that neither our NDA or PMA meets the regulatory requirements
to warrant a complete agency review. The primary grounds of rejection asserted
by the FDA relates to our use of prior Phase 3 clinical trial data, generated by
Novartis in a "superiority" endpoint study against sorafenib (Bayer), to support
a "non-inferiority" endpoint in connection with the DRP®-Dovitinib companion
diagnostic. Based upon the reasons given in the RTF letters and a subsequent
Type C meeting with the FDA on May 31, 2022, we anticipate that the FDA will
require a prospective Phase 3 clinical trial as well as additional dose
optimization studies before regulatory approval of Dovitinib as a monotherapy
and its companion diagnostic Dovitinib-DRP for the treatment of third-line mRCC
can be obtained. While we have decided that the costs, risks and potential
benefits of conducting these studies for dovitinib as a monotherapy for mRCC are
no longer the best path toward commercial success, we continue to evaluate other
potential Phase 1b/2 clinical trials for dovitinib combined with other approved
drugs in the mRCC space and in other indications. For example, we anticipate
commencing a stenoparib in combination with dovitinib Phase 1b/2 clinical trial
for second-line or later treatment of metastatic ovarian cancer. Our decision to
advance dovitinib as a combination therapy and not as a monotherapy is based on
our belief that both the science and the market for oncology therapies has
shifted towards combination therapies and away from monotherapies for multiple
indications of cancer



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As part of its new strategic pipeline focus, and subject to financing, the
Company has announced it expects to initiate enrollment in a Phase 1b/2 study of
its PARP inhibitor, stenoparib, in combination with its pan-TKI, dovitinib, for
the second-line or later treatment of metastatic ovarian cancer by or before Q4
2022. The Company plans to have trial sites in both the U.S. and Europe. The
Company is currently evaluating other potential Phase 1b/2 studies for either
stenoparib or dovitinib combined with another oncology therapeutic, including
the mRCC space. The Company's ongoing Phase 2 studies of stenoparib, as
monotherapy for ovarian cancer, and IXEMPRA®, as monotherapy for metastatic
breast cancer, will continue through their interim data readouts, now
anticipated in Q4 2022 and Q1 2023, respectively. All pipeline development
activities will continue to utilize drug-specific DRP® companion diagnostics to
guide patient selection and treatment.



Second Amendment to the License Agreement



On September 27, 2022, we entered into a Second Amendment to License Agreement
(the "Second Amendment") with Novartis Pharma AG, a company organized under the
laws of Switzerland, which amended the terms of the License Agreement dated
April 6, 2018 (the "Original Agreement"), as amended by that certain First
Amendment to License Agreement effective as of March 30, 2022 ("Amendment" and
together with the Original Agreement, the "Agreement") and that certain
Promissory Note dated April 6, 2018, which was re-issued by Allarity
Therapeutics Denmark ApS, a subsidiary of Allarity Europe, in favor of Novartis
on March 30, 2022, to modify the terms and timing of the Outstanding Milestone
Payment (as defined in the Second Amendment). The Second Amendment increase the
amount of the total milestone payment by $500,000. The Second Amendment became
effective upon receipt by Novartis of the first portion of the Outstanding
Milestone Payment, which was made on or about September 28, 2022.



Under Clause 7.2 of the Original Agreement, the Company agreed to pay Novartis a
milestone payment in one lump sum ("Third Milestone Payment") upon submission of
the first NDA with the FDA for a Licensed Product in the United States (the
"Third Milestone"). The Second Amendment restructured the terms of the Third
Milestone Payment to an installment plan (with the final installment due in
2023), allowing the Company more time to make the Third Milestone Payment. In
addition, the Second Amendment amended (1) Clause 1.1 of the Agreement to
include the definitions of Financing Transaction, Phase 1 Clinical Trial and
Phase 1b/2 Clinical Trial, (2) Clause 2.1 of the Agreement to clarify that the
Company would not be permitted to sublicense any rights granted to the Company
prior to completion of a Phase II Clinical Trial without the prior written
consent of Novartis, and (3) Clause 7.3 to provide for the acceleration of
certain milestone payments in the event the Company enters into a Financing
Transaction (as defined in the Second Amendment). If all milestones under the
Second Amendment are achieved, the Company may be obligated to pay Novartis up
to a maximum of $26.5 million.



Change in Board of Directors and annual fee



From July to September 2022, the Board increased the fixed number of authorized
directors on the Board to seven (7). To fill the vacancies, the Board appointed
Messrs. James G. Cullem as Class III director, Thomas Jensen as Class I
director, Dr. Roth as Class II director, and Mr. McLaughlin as Class II
director.



Messrs. Cullem and Jensen are executive officers of the Company. In addition to
serving as a director of the Company, Mr. Cullem will continue to serve as the
Company's Chief Executive Officer and Chief Business Officer. In addition, Mr.
Jensen will continue to serve as the Company's Senior Vice President, Investor
Relations.



In connection with the appointment of Dr. Roth and Mr. McLaughlin as independent
directors of the Company, each will receive an annual retainer fee of $50,
payable in cash, and if appointed to a committee of the Board, the respective
director will be eligible to receive $7.5 for serving as a member of the Audit
Committee, $4 for serving as a member of the Nominating and Corporate Governance
Committee and $5 for serving as a member of the Compensation Committee. In
addition, the Board granted each independent director options to purchase 23,000
shares of common stock at an exercise price of $1.28 and $1.10 per share,
subject to vesting of 1/36 per month over thirty-six (36) months following the
grant date. The expiration date for the options is five (5) years from date
of
grant.


Also effective July 7, 2022On the recommendation of the Compensation Committee, the Board approved an increase in the annual fee for independent directors $50.


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Change in Management


In June 2022, the Company effected a change in management. Effective as of June
29, 2022, Steve Carchedi resigned from all positions in the Company, including
his role of Chief Executive Officer and as a director of the Company. In
addition, effective as of June 27, 2022, Jens Knudsen resigned from all
positions in the Company, including his role of Chief Financial Officer of the
Company. Pursuant to the terms set forth in their respective separation
agreements with the Company, the Company agreed to provide Mr. Carchedi and Mr.
Knudsen with certain payments and benefits comprising of: (i) continued payments
of his base salary for a certain time period and (ii) COBRA coverage for a
certain number of months ("Severance Benefits"). In exchange for the Severance
Benefits, among other things, Messrs. Carchedi, and Knudsen each individually
agreed to a release of claims in favor of the Company and to certain restrictive
covenant obligations, and also reaffirmed his commitment to comply with their
respective existing restrictive covenant obligations.



With the departure of Mr. Carchedi, the Board of Directors of the Company (the
"Board") appointed James Mr. Cullem as the interim Chief Executive Officer of
the Company effective as of June 29, 2022. Accordingly, Mr. Cullem assumed the
role as the interim Chief Executive Officer and continues his role as the Chief
Business Officer. In addition, with the departure of Mr. Knudsen, the Board
appointed Joan Brown, the Company's current Director of Financial Reporting, as
the interim Chief Financial Officer of the Company effective as of June 29,
2022. In addition to Ms. Brown's role as Chief Financial Officer, she continues
her role as Director of Financial Reporting.



Risks and Uncertainties



The Company is subject to risks common to companies in the biotechnology
industry, including but not limited to, risks of failure of preclinical studies
and clinical trials, the need to obtain marketing approval for any drug product
candidate that it may identify and develop, the need to successfully
commercialize and gain market acceptance of its product candidates, dependence
on key personnel and collaboration partners, protection of proprietary
technology, compliance with government regulations, development by competitors
of technological innovations, and the ability to secure additional capital to
fund operations. Product candidates currently under development will require
significant additional research and development efforts, including preclinical
and clinical testing and regulatory approval prior to commercialization. Even if
the Company's research and development efforts are successful, it is uncertain
when, if ever, the Company will realize significant revenue from product sales.



Impact of COVID-19 on our business – update



In March 2020, the World Health Organization declared COVID-19 a global
pandemic. COVID-19 has had an impact on our operations as it caused some
unexpected delays in our clinical program activities as clinical trials were
delayed. Management is unable to estimate the future financial effects, if any,
to our business as a result of COVID-19 because of the high level of
uncertainties and unpredictable outcomes of this disease.



We are continuing to evaluate the impact of COVID-19 pandemic on our business
and are taking proactive measures to protect the health and safety of our
employees, as well as to maintain business continuity. Based on guidance issued
by federal, state, and local authorities, we transitioned to a remote work model
for our employees, effective March 16, 2020. During the recent months
restrictions due to COVID-19 have lifted significantly and as a result, our
Danish employees have returned to work. Our North American employees are
continuing to work remotely. We will continue to closely monitor and seek to
comply with guidance from governmental authorities and adjust our activities as
appropriate.



The ultimate impact of the COVID-19 pandemic or a similar health epidemic is
highly uncertain and subject to change. We do not yet know the full extent of
potential delays or impacts on our business, our clinical trial, healthcare
systems or the global economy. However, these effects could harm our operations,
and we will continue to monitor the COVID-19 situation closely.



                                       34




Effects of the Russia-Ukraine War

There have been immense flows of refugees to Europe and Denmark is ready to
facilitate and to accept refugees from the Ukraine. It is far too early to
estimate how many migrants Denmark will facilitate, but immigration officials
have begun preparing to accept Ukrainian refugees. Being a North Atlantic Treaty
Organization (NATO) member, Denmark will strengthen its own national
preparedness as well as that of the NATO defense alliance. The Ukraine crisis
has become a new a destabilizing factor in the Danish and global economy. It
dampens growth and increases inflation at a time when inflation and capacity
utilization is already high. While the Danish economy is generally robust and
able to handle new challenges, and it is expected to enter a pause in growth.
However, there are risks of a fall in activity in the Danish economy in general.
To date the war has not yet had an impact on our results of operations however
we expect it may have an impact on the costs of materials we purchase for our
laboratory operations in Denmark but, we cannot predict or quantify the impact
now.



Financial Operations Overview


Since our inception in September of 2004, we have focused substantially all our
resources on conducting research and development activities, including drug
discovery and preclinical studies, establishing, and maintaining our
intellectual property portfolio, the manufacturing of clinical and research
material, hiring personnel, raising capital and providing general and
administrative support for these operations. In recent years, we have recorded
very limited revenue from collaboration activities, or any other sources. We
have funded our operations to date primarily from convertible notes and the
issuance and sale of our securities.



We have incurred net losses in each year since inception. Our net losses were
$8.2 million and $8.5 million for the six months ended June 30, 2022, and June
30, 2021, respectively. As of June 30, 2022, we had an accumulated deficit of
$74.7 million. Substantially all our net losses have 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 over at
least the next several years. We expect our expenses will increase substantially
in connection with our ongoing activities, as we:



  ? advance drug candidates through clinical trials;

  ? pursue regulatory approval of drug candidates;




  ? operate as a public company;

  ? continue our preclinical programs and clinical development efforts;

? continued research activities to discover new drug candidates; and

  ? manufacture supplies for our preclinical studies and clinical trials.



Components of operating expenses

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research and development costs

Research and development costs include:

? Costs incurred under agreements with third-party contracting organizations,

and consultants;

? Costs related to the manufacture of drug substances, including contract fees

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Manufacturer;

? laboratory and vendor costs associated with conducting pre-clinical studies;

and

  ? employee-related expenses, which include salaries, benefits and stock-based
    compensation.




                                       35




We expense all research and development costs in the periods in which they are
incurred. Costs for certain development activities are recognized based on an
evaluation of the progress to completion of specific tasks and estimates of
services performed using information and data provided to us by our vendors and
third-party service providers. Non-refundable advance payments for goods or
services to be received in future periods for use in research and development
activities are deferred and accounted for as prepaid expenses. The prepayments
are then expensed as the related goods are delivered and as services are
performed.



To date, most of these expenses have been related to the further development of our lead drug candidates Dovitinib, Stenoparib and IXEMPRA®.



We expect our research and development expenses to increase substantially for
the foreseeable future as we continue to invest in research and development
activities related to developing our drug candidates, as our drug candidates
advance into later stages of development, and as we continue to conduct clinical
trials. The process of conducting the necessary clinical research to obtain
regulatory approval is costly and time-consuming, and the successful development
of our drug candidates is highly uncertain. As a result, we are unable to
determine the duration and completion costs of our research and development
projects or when and to what extent we will generate revenue from the
commercialization and sale of any of our drug candidates.



General and administrative expenses

General and administrative expenses consist primarily of personnel-related
costs, facilities costs, depreciation and amortization expenses and professional
services expenses, including legal, human resources, audit, and accounting
services. Personnel-related costs consist of salaries, benefits, and stock-based
compensation. Facilities costs consist of rent and maintenance of facilities. We
expect our general and administrative expenses to increase for the foreseeable
future due to anticipated increases in headcount to advance our drug candidates
and as a result of operating as a public company, including expenses related to
compliance with the rules and regulations of the SEC, Nasdaq Stock Market,
additional insurance expenses, investor relations activities and other
administrative and professional services.



Operating results for the past three and six months June 30, 2022and June 30, 2021 (unaudited)

The table below summarizes our operating results for the past three and six months June 30, 2022and 2021:



                             For the three months ended                             For the six months ended
                                      June 30,                   Increase/                  June 30,                   Increase/
                              2022                2021          (Decrease)          2022                2021          (Decrease)
                                   (In thousands)                                        (In thousands)
                                               (Restated)                                            (Restated)
Operating costs and
expenses:
Research and
development               $       1,696       $       2,279     $      (583 )   $       2,985       $       3,531     $      (546 )
Impairment of
intangible assets                     -                   -               -            14,007                   -          14,007
General and
administrative                    3,146               2,097           1,049             6,159               3,307           2,852
Total operating costs
and expenses                      4,842               4,376             466            23,151               6,838          16,313
Loss from operations:     $      (4,842 )     $      (4,376 )   $      (466 )   $     (23,151 )     $      (6,838 )   $   (16,313 )




                                       36




research and development costs

We do not currently track our research and development expenses by product candidate. A breakdown by type of spend for the past three and six months June 30, 2022and 2021 is given below.


                              For the three months ended                            For the six months ended
                                       June 30,                   Increase/                 June 30,                  Increase/
                               2022                2021          (Decrease)          2022               2021         (Decrease)
                                    (In thousands)                                       (In thousands)
                                                (Restated)                                           (Restated)
Research study expenses    $         535                 439     $        96     $      1,040       $      1,197     $      (157 )
Tax credit                          (136 )              (219 )            83             (590 )             (438 )          (152 )
Manufacturing & supplies              (7 )               722            (729 )            161                793            (632 )
Contractors                          722                 863            (141 )          1,099              1,079              20
Patents                              (15 )                 7             (22 )             61                 67              (6 )
Staffing                             574                 394             179            1,183                710             473
Amortization                          18                  32             (14 )             38                 68             (30 )
Other                                  5                  40             (35 )             (7 )               55             (62 )
                           $       1,696       $       2,279     $      (583 )   $      2,985       $      3,531     $      (546 )



For the past three months June 30, 2022 and, June 30, 2021 (Rephrased)



The decrease of $583 in research and development expenses was primarily because
of a $96 increase in research and development expenses and a $179 increase in
staffing, offset by decreases of $83 in tax credits and decreases of $729 in
manufacturing and supplies costs, $141 in contractor costs, $22 in patent costs,
$14 in amortization and $35 in other expenses. Research and development expenses
decreased overall because of decreased clinical research activity. Specifically,
manufacturing and supplies and contractor costs have decreased since we have
decreased our clinical activity to two of our three top priority assets while we
prioritize our clinical programs and staffing expenses increased due to accrued
severance.


For the past six months June 30, 2022 and June 30, 2021 (Rephrased)



The decrease of $546 in research and development expenses was primarily because
of a $473 increase in staffing and a $20 increase in contractors, offset by an
increase in tax credits of $152 and decreases of $157 in research study
expenses, $6 in patent costs, $30 in amortization, and $62 in other expenses.
Research and development expenses decreased overall because of decreased
clinical activity. Staffing expenses increased primarily due to accrued
severance.



Impairment of intangible assets

As a result of both the Company's February 15, 2022, receipt of a RTF from the
U.S. Food and Drug Administration regarding the Company's NDA for Dovitinib, and
the current depressed state of the Company's stock price, the Company has
performed an impairment assessment on its individual intangible assets utilizing
a discounted cash flow model and recognized an impairment charge of $14.0
million during the six months ended June 30, 2022.



General and administrative expenses

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For the past three months June 30, 2022 and June 30, 2021 (Rephrased)



General and administrative expenses increased by $1,049 for the three months
ended June 30, 2022, compared to June 30, 2021. The increase was primarily due
to an increase in audit and legal expenses of $610, insurance expense of $418,
consulting expenses of $300, and communications expense of $10, offset by a
decrease in premises expense of $30, staffing expenses of $149, listings
expenses of $16. and other administrative expenses of $94. Staffing expenses
decreased primarily due to decreased stock-based compensation expense as a
result of stock option forfeitures, offset by severance accruals.



                                       37




For the past six months June 30, 2022 and June 30, 2021 (Rephrased)



General and administrative expenses increased by $2.9 million for the six months
ended June 30, 2022, compared to June 30, 2021. The increase was primarily due
to increases in audit and legal expense of $1.3 million, insurance expense of
$760, staffing expenses of $486, consulting expenses of $300, listings expenses
of $75, and communications expense of $25, offset by a decrease in premises
expense of $26, and other administrative expenses of $25. Staffing increased in
the six months ended June 30, 2022, primarily because of severance accruals.



Other income (expense), net

For the past three months June 30, 2022 and June 30, 2021 (Rephrased)

Other income (expense) of ($257) recognized in the three months ended June 30,
2022, consisted primarily of an ($800) Registration Delay Payment paid to 3i,
($269) in foreign exchange losses, ($34) loss on our investment, and ($33) in
interest expenses, offset by an $874 fair value adjustment to derivative and
warrant liabilities and $5 of interest income. In the three months ended
June 30, 2021, other income (expense) of ($1.0) million consisted primarily of
finance expenses of ($393), change in fair value of convertible debt of ($273),
interest expenses of ($166), loss on investment of ($67), foreign exchange
losses of ($41), fair value adjustment of derivative liability of ($25), and
loss on extinguishment of convertible debt of ($25).



For the past six months June 30, 2022 and June 30, 2021 (Rephrased)

Other income (expense) of $13.7 million recognized in the six months ended June
30, 2022, consisted primarily of a $13.4 million fair value adjustment to
derivative and warrant liabilities, income of $1.8 million from the gain on sale
of IP, and interest income of $5, offset by ($538) in foreign exchange losses,
($72) in interest expenses, and ($70) loss on investment. In the six months
ended June 30, 2021, other income (expense) of ($1.6) million consisted of
finance expenses of ($480), change in fair value of convertible debt of ($474),
interest expenses of ($245), loss on investment of ($180), loss on
extinguishment of convertible debt of ($141), foreign exchange losses of ($80),
offset by a $20 fair value adjustment of derivative liability.



Changes in the fair value of our derivative liabilities and convertible debt instruments are measured using Level 3 inputs as described in our condensed consolidated financial statements.


Income Taxes


For the past three months June 30, 2022 and June 30, 2021 (Rephrased)

Income tax refund (expense) was ($4) for the past three months June 30, 2022
versus ($30) for the past three months June 30, 2021.

For the six-month periods ended June 30, 2022 and June 30, 2021 (Restated)



Income tax recovery (expense) was $1.2 million for the six months ended June 30,
2022, versus ($63) for the six months ended June 30, 2021. The increase in
income tax recovery of $1.3 million was primarily because the March31, 2022,
impairment charge of approximately $14 million resulted in a tax benefit of $1.2
million for the six months ended June 30, 2022.



Liquidity, capital resources and operational plan

Since our inception our operations have been financed primarily by the sale of
convertible promissory notes and the sale and issuance of our securities As of
June 30, 2022, we had $7.7 million in cash, and an accumulated deficit of $74.7
million.



                                       38





Our primary use of cash is to fund operating expenses, which consist of research
and development as well as regulatory expenses related to our therapeutic drug
candidate, dovitinib, and clinical programs for stenoparib and IXEMPRA®, and to
a lesser extent, general and administrative expenses. Cash used to fund
operating expenses is impacted by the timing of when we pay these expenses, as
reflected in the change in our outstanding accounts payable and accrued
expenses.



As of June 30, 2022, the Company's cash deposits of $7.7 million were determined
to be insufficient to fund its current operating plan and planned capital
expenditures for the next 12 months. These conditions give rise to a substantial
doubt over the Company's ability to continue as a going concern.



Management's plans to mitigate the conditions or events that raise substantial
doubt include additional funding through public equity, private equity, debt
financing, collaboration partnerships, or other sources. There are no
assurances, however, that the Company will be successful in raising additional
working capital, or if it is able to raise additional working capital, it may be
unable to do so on commercially favorable terms. The Company's failure to raise
capital or enter into other such arrangements when needed would have a negative
impact on its business, results of operations and financial condition and its
ability to maintain current operations and develop its product candidates.



We expect to incur substantial expenses in the foreseeable future for the
development and potential commercialization of our drug candidates and ongoing
internal research and development programs. At this time, we cannot reasonably
estimate the nature, timing, or aggregate amount of costs for our development,
potential commercialization, and internal research and development programs.
However, to complete our current and future preclinical studies and clinical
trials, and to complete the process of obtaining regulatory approval for our
drug candidates, as well as to build the sales, marketing, and distribution
infrastructure that we believe will be necessary to commercialize our drug
candidates, if approved, we may require substantial additional funding in the
future.


Contractual Obligations and Commitments

We enter into agreements in the normal course of business with vendors for
preclinical studies, clinical trials and other service providers for operating
purposes. We have not included these payments in the table of contractual
obligations above since these contracts are generally cancellable at any time by
us following a certain period after notice and therefore, we believe that our
non-cancellable obligations under these agreements are not material.

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