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

VIKING THERAPEUTICS, INC.  Management’s Discussion and Analysis of Financial Condition and Results of Operations (Form 10-Q)
This Quarterly Report on Form 10-Q contains "forward-looking statements" as
defined in Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, in connection
with the Private Securities Litigation Reform Act of 1995 that involve risks and
uncertainties, as well as assumptions that, if they never materialize or prove
incorrect, could cause our results to differ materially and adversely from those
expressed or implied by such forward-looking statements. Such forward-looking
statements include estimates of our expenses, future revenue, capital
requirements and our needs for additional financing; statements regarding our
ability to develop, acquire and advance drug candidates into, and successfully
complete, clinical trials and preclinical studies; statements concerning new
product candidates; risks and uncertainties associated with our research and
development activities, including our clinical trials and preclinical studies;
our expectations regarding the potential market size and the size of the patient
populations for our drug candidates, if approved for commercial use, and our
ability to serve such markets; statements regarding our ability to maintain and
establish collaborations or obtain additional funding; statements regarding
developments and projections relating to our competitors and our industry and
other matters that do not relate strictly to historical facts or statements of
assumptions underlying any of the foregoing. These statements are often
identified by the use of words such as "anticipate," "believe," "continue,"
"could," "estimate," "expect," "intend," "may" or "will," the negative versions
of these terms and similar expressions or variations. These statements are based
on the beliefs and assumptions of our management based on information currently
available to management. Such forward-looking statements are subject to risks,
uncertainties and other factors that could cause actual results and the timing
of certain events to differ materially and adversely from future results
expressed or implied by such forward-looking statements. Factors that could
cause or contribute to such differences include, but are not limited to, those
identified below, and those discussed in the section titled "Risk Factors"
included elsewhere in this Quarterly Report on Form 10-Q and in our other
Securities and Exchange Commission, or SEC, filings. Furthermore, such
forward-looking statements speak only as of the date of this Quarterly Report on
Form 10-Q. We undertake no obligation to update any forward-looking statements
to reflect events or circumstances occurring after the date of such statements.

Throughout this Quarterly Report on Form 10-Q, unless the context otherwise requires, the terms “Viking”, “we”, “us” and “our” in this Quarterly Report on Form 10-Q refer to Viking Therapeutics, Inc. and its subsidiary.

Overview


We are a clinical-stage biopharmaceutical company focused on the development of
novel, first-in-class or best-in-class therapies for metabolic and endocrine
disorders.

The drug candidate in our lead clinical program, VK2809, is an orally available tissue and receptor subtype-selective agonist of thyroid hormone receptor beta, or TRß. In November 2019we initiated the VOYAGE study, a phase 2b clinical trial of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis or NASH.


The VOYAGE study is a randomized, double-blind, placebo-controlled, multicenter
trial designed to assess the efficacy, safety and tolerability of VK2809 in
patients with biopsy-confirmed NASH and fibrosis ranging from stages F1 to F3.
The primary endpoint of the study will evaluate the relative change in liver fat
content, as assessed by magnetic resonance imaging, proton density fat fraction,
from baseline to week 12 in subjects treated with VK2809 as compared to placebo.
Secondary objectives include evaluation of histologic changes assessed by
hepatic biopsy after 52 weeks of dosing.

VK2809 has been evaluated in eight completed clinical studies, which enrolled
more than 300 subjects. No serious adverse events, or SAEs, have been observed
in subjects receiving VK2809 in these completed studies, and overall
tolerability remains encouraging. In addition, the compound has been evaluated
in chronic toxicity studies of up to 12 months in duration.

We are also developing VK0214, which is also an orally available, tissue and
receptor-subtype selective agonist of TRß for X-linked adrenoleukodystrophy, or
X-ALD, a rare X-linked, inherited neurological disorder characterized by a
breakdown in the protective barriers surrounding brain and nerve cells. The
disease, for which there is no approved treatment, is caused by mutations in a
peroxisomal transporter of very long chain fatty acids, or VLCFA, known as
ABCD1. As a result, transporter function is impaired and patients are unable to
efficiently metabolize VLCFA. The TRß receptor is known to regulate expression
of an alternative VLCFA transporter, known as ABCD2. Various preclinical models
have demonstrated that increased expression of ABCD2 can lead to normalization
of VLCFA metabolism. Preliminary data suggest that VK0214 stimulates ABCD2
expression in an in vitro model and reduces VLCFA levels in an in vivo model of
X-ALD.

In June 2021, we initiated a Phase 1b clinical trial of VK0214 in patients with
X-ALD. This trial is a multi-center, randomized, double-blind,
placebo-controlled study in adult male patients with the adrenomyeloneuropathy,
or AMN, form of X-ALD. The study is initially targeting enrollment across three
cohorts: placebo, VK0214 20 mg daily, and VK0214 40 mg daily. Pending a blinded
review of preliminary safety, tolerability, and pharmacokinetic data, additional
dosing cohorts may be pursued.

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The primary objectives of the study are to evaluate the safety and tolerability
of VK0214 administered once-daily over a 28-day dosing period. Secondary and
exploratory objectives include an evaluation of the pharmacokinetics and
pharmacodynamics of VK0214 following 28 days of dosing in this population.

In January 2022, we announced the initiation of a Phase 1 single ascending dose,
or SAD, and multiple ascending dose, or MAD, clinical trial of VK2735, a novel
dual agonist of the glucagon-like peptide 1, or GLP-1, and glucose-dependent
insulinotropic polypeptide, or GIP, receptors. VK2735 is in development for the
potential treatment of various metabolic disorders.

The Phase 1 trial is a randomized, double-blind, placebo-controlled, SAD and MAD
study in healthy adults. The primary objectives of the study include evaluation
of the safety and tolerability of single and multiple doses of VK2735 delivered
subcutaneously and the identification of VK2735 doses suitable for further
clinical development. Study investigators will also evaluate the
pharmacokinetics of single and multiple doses of VK2735.

Other clinical programs include VK5211, an orally available, non-steroidal
selective androgen receptor modulator, or SARM. In November 2017, we announced
positive top-line results from a Phase 2 proof-of-concept clinical trial in 108
patients recovering from non-elective hip fracture surgery. Top-line data showed
that the trial achieved its primary endpoint, demonstrating statistically
significant, dose dependent increases in lean body mass, less head, following
treatment with VK5211 as compared to placebo. The study also achieved certain
secondary endpoints, demonstrating statistically significant increases in
appendicular lean body mass and total lean body mass for all doses of VK5211,
compared to placebo. VK5211 demonstrated encouraging safety and tolerability in
this study, with no drug-related SAEs reported. Our intent is to continue to
pursue partnering or licensing opportunities prior to conducting additional
clinical studies.

We were incorporated under the laws of the State of Delaware on September 24,
2012. Since our incorporation, we have devoted most of our efforts towards
conducting certain clinical trials and preclinical studies related to our
VK2809, VK0214, VK2735 and VK5211 programs and towards raising capital and
building infrastructure. We obtained exclusive worldwide rights to VK2809,
VK0214 and VK5211 and certain other assets pursuant to an exclusive license
agreement with Ligand Pharmaceuticals Incorporated, or Ligand. The terms of this
license agreement are detailed in the Master License Agreement with Ligand,
which we entered into on May 21, 2014, as amended, or the Master License
Agreement. A summary of the Master License Agreement can be found under the
heading "Agreements with Ligand-Master License Agreement" under Part I, "Item 1.
Business" of our Annual Report on Form 10-K filed with the SEC on February 9,
2022.

Impact of COVID-19 Pandemic

We are subject to risks and uncertainties as a result of the COVID-19 pandemic.
The extent of the impact of the COVID-19 pandemic on our business is highly
uncertain and difficult to predict, as the responses that we, other businesses
and governments are taking continue to evolve. Furthermore, capital markets and
economies worldwide have also been negatively impacted by the COVID-19 pandemic,
and it is possible that it could cause a local and/or global economic slowdown
or recession. Policymakers around the globe have responded with fiscal policy
actions to support the healthcare industry and economy as a whole. The magnitude
and overall effectiveness of these actions remain uncertain.

In addition, our clinical trials have been affected by, and may continue to be
affected by, the COVID-19 pandemic. Clinical site initiation and patient
enrollment have been, and may continue to be, delayed due to the prioritization
of hospital resources toward the COVID-19 pandemic. Some patients have not been
able to, and others may not be able to, comply with clinical trial protocols if
quarantines impede patient movement or interrupt healthcare services. Similarly,
any inability to recruit and retain patients and principal investigators and
site staff who, as healthcare providers, may have heightened exposure to
COVID-19, may adversely impact our clinical trial operations.

The severity of the impact of the COVID-19 pandemic on our business will depend
on a number of factors, including, but not limited to, the duration and severity
of the pandemic and the extent and severity of the impact on our service
providers, suppliers, contract research organizations, or CROs, and our clinical
trials, all of which are uncertain and cannot be predicted, as well as the
timing, rollout and availability of vaccines worldwide and the effectiveness
thereof, and willingness of the general population to be vaccinated, and the
potential emergence and spread of any new variants, including Omicron and
sub-variants thereof. As of the date of issuance of our consolidated financial
statements, the extent to which the COVID-19 pandemic may materially impact our
financial condition, liquidity or results of operations is still uncertain.

Summary of financial operations

Income

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To date, we have not generated any revenue. We do not expect to receive any income from any drug candidates we develop unless and until we obtain regulatory approval and commercialize our drug candidates or enter into collaborative agreements with third parties.

Research and development expenses


During the year ended December 31, 2021, we charged $45.0 million to research
and development expense primarily related to our efforts in continuing to
conduct the VK2809 Phase 2b VOYAGE clinical trial, completing the VK0214 Phase 1
SAD and MAD study in healthy patients, preparing for and initiating the VK0214
Phase 1b trial and preparing for the initiation of the VK2735 Phase 1 trial.
During the nine months ended September 30, 2022, we charged $38.1 million to
research and development expense primarily related to our efforts in continuing
to conduct the VK2809 Phase 2b VOYAGE clinical trial, efforts related to our
Phase 1b clinical trial of VK0214 in patients with X-ALD, and continuing to
conduct our Phase 1 SAD and MAD clinical trial of VK2735, currently in
development for the treatment of various metabolic disorders. We expect that our
ongoing research and development expenses will consist of costs incurred for the
development of our drug candidates, including, but not limited to:



• Expenses related to employees and consultants, which will include salaries,

        benefits and stock-based compensation, and certain consultant fees and
        travel expenses;



    •   expenses incurred under agreements with investigative sites and CROs,
        which will conduct a substantial portion of our research and
        development activities, including studies in NASH and X-ALD, on our
        behalf;


• payments to third party manufacturers, who will produce our asset

        pharmaceutical ingredients and finished drug products;


• license fees paid to third parties for the use of your intellectual property;

        and



    •   facilities, depreciation and other allocated expenses, which will
        include direct and allocated expenses for rent and maintenance of
        facilities and equipment, depreciation of leasehold improvements,
        equipment and laboratory and other supplies.


We spend all research and development costs that are incurred.


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. Our future research and development expenses
will depend on the clinical success of each of our drug candidates, as well as
ongoing assessments of the commercial potential of such drug candidates. In
addition, we cannot forecast with any degree of certainty which drug candidates
may be subject to future collaborations, when such arrangements will be secured,
if at all, and to what degree such arrangements would affect our development
plans and capital requirements. We expect to incur increased research and
development expenses in the future as we continue our efforts towards advancing
our VK2809, VK2735 and VK0214 programs and seek to advance our additional
programs.

General and adminsitrative expenses


Our general and administrative expenses have generally increased year-over-year
as we have hired additional employees, issued additional equity awards, which
has resulted in increased stock-based compensation expense, implemented certain
systems to increase efficiency, and incurred additional costs for insurance,
legal and accounting related to operating as a public company. We expect that
our general and administrative expenses will continue to increase in the future
in order to support our expected increase in research and development
activities, including increased salaries and other related costs, stock-based
compensation and consulting fees for executive, finance, accounting and business
development functions. We also expect general and administrative expenses to
increase as a result of additional costs associated with being a public company,
including expenses related to continued compliance with the rules and
regulations of the SEC and The Nasdaq Stock Market LLC, additional insurance
expenses, investor relations activities and other administration and
professional services. Other significant costs are expected to include legal
fees relating to patent and corporate matters, facility costs not otherwise
included in research and development expenses, and fees for accounting and other
consulting services.

Other Income (Expense)

Other income (expense) includes interest income earned on our cash, cash equivalents and short-term investments.

Smallest reporting company and non-accelerated filer



In March 2020, the SEC released final rules amending the definitions for
accelerated and large accelerated filers. In addition, these final rules also
exclude from these definitions of accelerated and large accelerated filers an
issuer that is eligible to be a smaller

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reporting company and non-accelerated filer. As our public float on June 30,
2022 was less than $700 million and our annual revenues were less than $100
million, we continue to be deemed a smaller reporting company and a
non-accelerated filer until at least December 31, 2023. As a non-accelerated
filer and in accordance with these new rules, we are not required to provide an
auditor's attestation report on our internal control over financial reporting in
our annual reports on Form 10-K as otherwise required by Section 404(b) of the
Sarbanes-Oxley Act of 2002, as amended. In addition, as a smaller reporting
company, we have the ability to take advantage of several "scaled disclosure"
accommodations in accordance with the smaller reporting company rules. We will
need to reassess, as of June 30, 2023, whether we continue to qualify as a
smaller reporting company and a non-accelerated filer for filings beyond the
fiscal year ending December 31, 2023.

Critical Accounting Policies and Estimates


Our management's discussion and analysis of financial condition and results of
operations is based on our consolidated financial statements, which have been
prepared in accordance with accounting principles generally accepted in the
United States. The preparation of these 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 consolidated financial statements, as well as the
reported revenues and expenses during the reporting periods. On an ongoing
basis, we evaluate our estimates and judgments related to our preclinical,
nonclinical and clinical development costs and drug manufacturing costs, which
we consider as a critical accounting estimate. 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. Actual results may differ from these
estimates under different assumptions or conditions.

Our significant accounting policies are more fully described in Note 1 and Note
3 to our consolidated financial statements included in Part I, Item 1 of this
Quarterly Report on Form 10-Q.

Results of Operations

Comparison of the three months ended September 30, 2022 and 2021

Research and development expenses


The following table summarizes our research and development expenses for the
three months ended September 30, 2022 and 2021 (in thousands, except % change).


                                                                                         $             %
                                             Three Months Ended September 30,         Change         Change
                                                2022                  2021

Research and development expenses $11,959 $10,795 $1,164

           10.8 %




The increase in research and development expenses during the three months ended
September 30, 2022 as compared to the same period in 2021 was primarily due to
increased expenses related to manufacturing for our drug candidates, clinical
studies, salaries and benefits, pre-clinical studies and stock-based
compensation, partially offset by the receipt of funds in connection with the
Australian research and development tax incentive program and decreased expenses
related to our third-party consultants.

General and adminsitrative expenses


The following table summarizes our general and administrative expenses for the
three months ended September 30, 2022 and 2021 (in thousands, except % change).
                                                                                             $             %
                                               Three Months Ended September 30,           Change         Change
                                                 2022                     2021

General and administrative expenses $4,237 $

   2,608     $   1,629           62.5 %




The increase in general and administrative expenses during the three months
ended September 30, 2022 as compared to the same period in 2021 was primarily
due to increased expenses related to legal services, stock-based compensation
and salaries and benefits.



Other income (expense)

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The following table summarizes our other income (expenses) for the three months ended September 30, 2022 and 2021 (in thousands, except percentage change).

                                                                          $            %
                             Three Months Ended September 30,           Change      Change
                              2022                      2021
Other income (expense)   $           423           $           160     $    263       164.4 %


Other income (expense) recognized during the three months ended September 30, 2022 consisted primarily of interest income, partially offset by expenses related to the amortization of certain finance costs.

Other income (expense) recognized during the three months ended September 30, 2021 consisted primarily of interest income, partially offset by expenses related to the amortization of certain finance costs.

Comparison of the Nine Months Ended September 30, 2022 and 2021

Research and development expenses


The following table summarizes our research and development expenses for the
nine months ended September 30, 2022 and 2021 (in thousands, except % change).


                                                                                         $             %
                                              Nine Months Ended September 30,         Change         Change
                                                2022                  2021

Research and development expenses $38,056 $35,134 $2,922

            8.3 %




The increase in research and development expenses during the nine months ended
September 30, 2022 as compared to the same period in 2021 was primarily due to
increased expenses related to our manufacturing for our drug candidates,
clinical studies, salaries and benefits and stock-based compensation, partially
offset by the receipt of funds in connection with the Australian research and
development tax incentive program and decreased expenses related to our
pre-clinical studies and third-party consultants.

General and adminsitrative expenses


The following table summarizes our general and administrative expenses for the
nine months ended September 30, 2022 and 2021 (in thousands, except % change).


                                                                                       $             %
                                             Nine Months Ended September 30,        Change         Change
                                              2022                  2021

General and adminsitrative expenses $12,016 $8,038 $3,978

           49.5 %




The increase in general and administrative expenses during the nine months ended
September 30, 2022 as compared to the same period in 2021 was primarily due to
increased expenses related to legal services, stock-based compensation, and
salaries and benefits.



Other income (expense)

The following table summarizes our other income (expenses) for the nine months ended September 30, 2022 and 2021 (in thousands, except percentage change).


                                                                          $            %
                              Nine Months Ended September 30,           Change      Change
                              2022                      2021
Other income (expense)   $           764           $           538     $    226        42.0 %



Other income (expense) recognized during the nine months ended September 30,
2022 consisted primarily of interest income, partially offset by a realized loss
on investments and expense relating to the amortization of certain financing
costs.
Other income (expense) recognized during the nine months ended September 30,
2021 consisted primarily of interest income, partially offset by expense
relating to the amortization of certain financing costs.

Liquidity and Capital Resources

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We have incurred losses and negative cash flows from operations and have not
generated any revenues since our inception. As of September 30, 2022, we had
cash, cash equivalents and short-term investments of $155.0 million. As such, we
believe our cash, cash equivalents and short-term investments will be sufficient
to fund our operations through at least December 31, 2023, which is more than
one year after the date of our filing of this Form 10-Q.

Our primary use of cash is to fund operating expenses, which to date have
consisted of the cost to obtain the license of intellectual property from
Ligand, certain research and development expenses related to furthering the
development of VK2809, VK0214, VK5211 and VK2735, and general and administrative
expenses. Since we have not generated any revenues to date, we have incurred
operating losses since our inception. Cash used to fund operating expenses is
impacted by the timing of payment of these expenses, as reflected in the change
in our outstanding accounts payable and accrued expenses.

On July 28, 2021, we filed with the SEC a universal Shelf Registration Statement
on Form S-3 (File No. 333-258231), or the 2021 Shelf Registration Statement. The
2021 Shelf Registration Statement initially provides us with the ability to
offer up to $600.0 million of securities, including equity, debt and other
securities as described in the 2021 Shelf Registration Statement. The 2021 Shelf
Registration Statement was declared effective by the SEC on August 11, 2021 and
will expire on August 11, 2024. Pursuant to the 2021 Shelf Registration
Statement, we may offer additional securities from time to time and through one
or more methods of distribution, subject to market conditions and our capital
needs.

On July 28, 2021, we entered into an At-The-Market Equity Offering Sales
Agreement, or the ATM Agreement, with Stifel, Nicolaus & Company, Incorporated,
Truist Securities, Inc. and H.C. Wainwright & Co. LLC, or, collectively, the
Agents, pursuant to which we may offer and sell, from time to time, through or
to the Agents, as sales agent or principal, or the ATM Offering, shares of our
common stock having an aggregate offering price of up to $125.0 million, or the
ATM Shares. Any ATM Shares offered and sold in the ATM Offering are to be issued
pursuant to the 2021 Shelf Registration Statement and the 424(b) prospectus
supplement relating to the ATM Offering dated August 11, 2021. No shares of our
common stock were sold under the ATM Agreement from its inception through
September 30, 2022.

On March 17, 2020, our board of directors authorized a stock repurchase program,
whereby we could purchase up to $50.0 million in shares of our common stock and
outstanding warrants to purchase our common stock, over a period of up to two
years (the "Repurchase Program"). The Repurchase Program could be carried out at
the discretion of a committee of the Company's Board of Directors through open
market purchases, one or more Rule 10b5-1 trading plans, block trades and in
privately negotiated transactions. Through March 17, 2022, the termination date
of the Repurchase Program, we repurchased an aggregate of 1,464,217 shares of
our common stock under the Repurchase Program. These shares repurchased by us
under the Repurchase Program are being held in treasury until such time as we
reissue or retire them.

On March 10, 2022, our board of directors authorized a new stock repurchase
program effective March 18, 2022, whereby we may purchase up to $50.0 million in
shares of our common stock and outstanding warrants to purchase our common
stock, over a period of up to two years (the "New Repurchase Program"). The New
Repurchase Program may be carried out at the discretion of a committee of our
board of directors through open market purchases, one or more Rule 10b5-1
trading plans, block trades and in privately negotiated transactions. Through
September 30, 2022, we repurchased an aggregate of 729,034 shares of our common
stock under the New Repurchase Program. These shares repurchased by us under the
New Repurchase Program are being held in treasury until such time as we reissue
or retire them.

The following table summarizes our cash flows for the periods indicated below
(in thousands):


                                                            Nine Months Ended September 30,
                                                              2022                   2021
Cash used in operating activities                       $        (37,471 )     $        (35,236 )
Cash provided by (used in) investing activities         $         47,493       $         10,550
Cash provided by (used in) financing activities         $         (6,586 )  

$6,833

Cash used in operating activities


During the nine months ended September 30, 2022, cash used in operating
activities of $37.5 million primarily reflected our net losses for the period,
adjusted by non-cash charges such as stock-based compensation, amortization of
investment premiums, amortization of right of use assets, amortization of
financing costs, and interest expense related to operating lease liabilities as
well as changes in our working capital accounts, primarily consisting of an
increase in accounts payable, accrued expenses, lease liability, accrued
interest, net of interest received on maturity of investments and other assets,
partially offset by an increase in prepaid expenses and right-of-use asset.

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During the nine months ended September 30, 2021, cash used in operating
activities of $35.2 million primarily reflected our net losses for the period,
adjusted by non-cash charges such as stock-based compensation, amortization of
investment premiums, amortization of right of use assets, amortization of
financing costs, and interest expense related to operating lease liability as
well as changes in our working capital accounts, primarily consisting of an
increase in accounts payable, accrued expenses and accrued interest, net of
interest received on maturity of investments, partially offset by an increase in
prepaid expenses and other assets and lease liability.

Cash provided by (used in) investing activities

During the nine months that ended September 30, 2022cash provided by investment activities of $47.5 million resulted mainly from the income from the maturities of the investments of $124.3 millionpartially offset by the purchase of investments from $76.8 million.

During the nine months that ended September 30, 2021cash provided by investment activities of $10.6 million resulted mainly from the income from the maturities of the investments of $143.0 millionpartially offset by the purchase of investments from $132.4 million.

Cash provided by (used in) financing activities

During the nine months that ended September 30, 2022cash used in financing activities was $6.6 millionwhich consisted mainly of $6.8 million in repurchases of our common shares under the Repurchase Program and the New Repurchase Program and the value of the shares withheld to cover the taxes of $499,000partially offset by income from certain warranty exercises $614,000 and proceeds from ESPP purchases of $85,000.

During the nine months that ended September 30, 2021Cash provided by financing activities was $6.8 millionconsisting principally of proceeds from certain licensing exercises $7.1 million and earnings from certain exercises of stock options and purchases of ESPPs from $504,000partially offset by the value of the shares withheld to cover taxes on $707,000.

Future Funding Requirements


As of the date of this Quarterly Report on Form 10-Q and based upon our current
operating plan, we believe that we have sufficient capital to fund our operating
and capital requirements for at least the next 12 months. We anticipate,
however, that we will continue to generate losses for the foreseeable future,
and we expect the losses to increase materially as we continue the development
of, and seek regulatory approvals for, our drug candidates, and seek to
commercialize any drugs for which we receive regulatory approval. We will need
to raise additional capital to fund our operations and complete our ongoing and
planned clinical trials. Although we expect to finance future cash needs through
public or private equity or debt offerings, funding may not be available to us
on acceptable terms, or at all. If we are unable to raise additional capital in
sufficient amounts or on terms acceptable to us, we may be required to delay,
limit, reduce or terminate our drug development or future commercialization
efforts or grant rights to develop and market drug candidates that we would
otherwise prefer to develop and market ourselves.

Our future capital requirements will depend on many factors, including but not limited to:

• the scope, rate of progress, results and costs of our clinical trials,

preclinical studies and other related activities;

• our ability to establish and maintain strategic collaborations, licenses

or other arrangements and the financial terms of such arrangements;

• the timing and costs involved in obtaining regulatory approvals

for any of our current or future drug candidates;

• the number and characteristics of drug candidates we seek to develop

or market;

• the cost of manufacturing clinical supplies and establishing a business

supplies, of our drug candidates;

• the cost of marketing activities if any of our current or future

        drug candidates are approved for sale, including marketing, sales and
        distribution costs;


  • the expenses needed to attract and retain skilled personnel;


  • the costs associated with being a public company;

• the amount of revenue, if any, received from commercial sales of our drug

candidates, in the event that any of our drug candidates receive marketing approval;

• the impacts that the global COVID-19 pandemic may have on our business,

financial condition and results of operations, including interruptions

our operations and clinical trials, as well as interruptions or delays with

regarding the operations of our service providers, vendors and CROs;

        and


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• the costs involved in the preparation, presentation, processing, maintenance,

defend and enforce potential patent claims, including litigation costs

and the outcome of any such litigation.

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