VIKING THERAPEUTICS, INC. 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 otherSecurities and Exchange Commission , orSEC , 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.
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.
Our lead clinical program's drug candidate, VK2809, is an orally available,
tissue and receptor-subtype selective agonist of the thyroid hormone receptor
beta, or TRß. In
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 study is targeting enrollment of approximately 340 patients across five treatment arms. 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 (MRI-PDFF), 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. InSeptember 2020 , we initiated a randomized, double-blind, placebo-controlled Phase 1 single ascending dose, or SAD, and multiple ascending dose, or MAD, clinical trial of VK0214 in healthy patients. The primary objective of the study is to evaluate the safety and tolerability of VK0214 administered orally for up to 14 days. The secondary objective is to evaluate the pharmacokinetics of VK0214 following single and multiple oral doses. InJune 2021 , we announced the results of the study. The first portion of the study evaluated single doses of VK0214; in the second portion of the study, subjects received VK0214 once daily for 14 days. Subsequent cohorts in both portions of the study received successively higher VK0214 doses. 20 -------------------------------------------------------------------------------- VK0214 was shown to be safe and well-tolerated at all doses evaluated in this study. No serious adverse events were reported, and no treatment or dose-related trends were observed for vital signs, gastrointestinal effects, cardiovascular measures or physical examinations. VK0214 demonstrated dose-dependent exposures, no evidence of accumulation following multiple doses, and a half-life consistent with anticipated once-daily dosing regimens. While the study's primary objective was to evaluate safety and tolerability, laboratory assessments included a lipid panel to determine potential pharmacodynamic effects following exposure to VK0214. The results showed that subjects who received VK0214 experienced reductions in low-density lipoprotein cholesterol, or LDL-C, triglycerides and apolipoprotein B following 14 days of treatment at all VK0214 doses. Many of the observed lipid reductions achieved statistical significance, though the study was not powered to demonstrate statistical significance on laboratory assessments. % Change in Lipid Markers Following 14 Days of Treatment of VK0214 Placebo1 5 mg 10 mg 25 mg 50 mg 75 mg 100 mg (n=11) (n=6) (n=6) (n=6) (n=6) (n=6) (n=6) LDL-C 3.8% -0.7% -12.5%* -21.4%** -19.5%** -19.1%*** -18.9%** Triglycerides 4.9% -6.7% -19.5%* -1.7% -36.8%** -45.0%*** -39.1%** ApoB 4.4% -5.7% -12.5%** -23.3%*** -24.0%*** -28.3%*** -28.2%*** (1) Excludes one placebo subject due to an anomalous triglyceride value (>7x higher than SD). *p < 0.05; **p < 0.01; ***p < 0.001. InJune 2021 , we initiated a Phase 1b clinical trial of VK0214 in patients with X-ALD. The Phase 1b 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. The primary objectives of the study are to evaluate the safety and tolerability of VK0214 administered once-daily over a 28-day dosing period, and to assess the efficacy of VK0214 at lowering plasma levels of VLCFAs in patients with AMN. Secondary objectives include an evaluation of the pharmacokinetics and pharmacodynamics of VK0214 following 28 days of dosing in this population. Other clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM. InNovember 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 theState of Delaware onSeptember 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 and VK5211 programs, as well as efforts towards raising capital and building infrastructure. We obtained exclusive worldwide rights to our VK2809, VK0214 and VK5211 programs 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 onMay 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 theSEC onFebruary 17, 2021 . 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 prioritization of hospital resources toward the COVID-19 pandemic. Some patients have not been able 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 21
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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 and the effectiveness thereof, and the willingness of the general population to be vaccinated. As of the date of issuance of our financial statements, the extent to which the COVID-19 pandemic may materially impact our financial condition, liquidity or results of operations is still uncertain.
Financial Operations Overview
Revenues
To date, we have not generated any revenue. We do not expect to receive any revenue from any drug candidates that we develop unless and until we obtain regulatory approval for, and commercialize, our drug candidates or enter into collaborative agreements with third parties.
Research and Development Expenses
During the year endedDecember 31, 2020 , we charged$31.9 million to research and development expense primarily related to our efforts in continuing to conduct the VK2809 Phase 2b VOYAGE clinical trial as well as preparing for and initiating the VK0214 Phase 1 SAD and MAD study in healthy patients. During the six months endedJune 30, 2021 , we charged$24.3 million to research and development expense primarily related to our efforts in continuing to conduct the VK2809 Phase 2b VOYAGE clinical trial and completing our VK0214 Phase 1 SAD and MAD clinical trial in healthy patients as well as preparing for and initiating our Phase 1b clinical trial of VK0214 in patients with X-ALD. 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:
• employee- and consultant-related expenses, 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, which will produce our active
pharmaceutical ingredients and finished drug products;
• license fees paid to third parties for use of their 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 expense all research and development costs as 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 and VK0214 programs and seek to advance our additional programs.
General and Administrative 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 compliance with the rules and
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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 from our cash, cash equivalents and short-term investments.
UntilDecember 31, 2020 , we were deemed an "emerging growth company" within the meaning of the rules under the Securities Act, and we utilized certain exemptions from various reporting requirements that were applicable to public companies that were not emerging growth companies. For example, as an emerging growth company, we were 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. EffectiveDecember 31, 2020 , we are no longer an emerging growth company asDecember 31, 2020 was the last day of the fiscal year following the fifth anniversary of the completion of our initial public offering. InMarch 2020 , theSEC 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 reporting company and non-accelerated filer. As our public float onJune 30, 2020 was less than$700 million and our annual revenues were less than$100 million , we have been deemed a smaller reporting company and a non-accelerated filer sinceJanuary 1, 2021 . 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 reassessed our public float as ofJune 30, 2021 , and since it was less than$700 million and our annual revenues are less than$100 million , we have determined that we will continue as a smaller reporting company and a non-accelerated filer until at leastDecember 31, 2022 . We will need to reassess, as ofJune 30, 2022 , whether we continue to qualify as a smaller reporting company and a non-accelerated filer for filings beyond the fiscal year endingDecember 31, 2022 .
Critical Accounting Policies and Estimates
Our management's discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted inthe United States . The preparation of these 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. On an ongoing basis, we evaluate our estimates and judgments related to the preclinical, nonclinical and clinical development costs and drug manufacturing costs. 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 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
Research and Development Expenses
The following table summarizes our research and development expenses for the
three months ended
$ %
Three Months Ended June 30, Change Change
2021 2020
Research and development expenses
23
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The increase in research and development expenses during the three months ended
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the
three months ended
$ %
Three Months Ended June 30, Change Change
2021 2020
General and administrative expenses
The decrease in general and administrative expenses during the three months endedJune 30, 2021 as compared to the same period in 2020 was primarily due to decreased expenses related to salaries and benefits of$131,000 and stock-based compensation of$100,000 , partially offset by increased expenses related to third-party consultants of$52,000 , professional fees of$48,000 and insurance of$42,000 . Other income (expense)
The following table summarizes our other income (expense) for the three months
ended
$ %
Three Months Ended June 30, Change Change
2021 2020
Other income (expense) $ 160 $ 1,034 $ (874 ) (84.5 )%
Other income (expense) recognized during the three months ended June 30, 2021
consisted primarily of interest income of $181,000 , partially offset by $21,000
of expense relating to the amortization of certain financing costs. Other income
(expense) recognized during the three months ended June 30, 2020 consisted
primarily of interest income of $1.0 million , partially offset by $20,000 of
expense relating to the amortization of certain financing costs.
Comparison of the Six Months Ended
Research and Development Expenses
The following table summarizes our research and development expenses for the six
months ended
$ %
Six Months Ended June 30, Change Change
2021 2020
Research and development expenses
The increase in research and development expenses during the six months endedJune 30, 2021 as compared to the same period in 2020 was primarily due to increased expenses related to our clinical studies of$6.3 million , pre-clinical studies of$1.8 million , manufacturing for our drug candidates of$470,000 and stock-based compensation of$58,000 , partially offset by a decrease in third-party consultants of$45,000 .
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the
six months ended
$ %
Six Months Ended June 30, Change Change
2021 2020
General and administrative expenses
$ (357 ) (6.2 )% 24
-------------------------------------------------------------------------------- The decrease in general and administrative expenses during the six months endedJune 30, 2021 as compared to the same period in 2020 was primarily due to decreased expenses related to stock-based compensation of$290,000 , salaries and benefits of$195,000 , legal services of$73,000 and travel expenses of$13,000 , partially offset by increased expenses related to professional fees of$94,000 , insurance of$89,000 and third-party consultants of$68,000 .
Other income (expense)
The following table summarizes our other income (expense) for the six months
ended
$ %
Six Months Ended June 30, Change Change
2021 2020
Other income (expense) $ 379 $ 2,294 $ (1,915 ) (83.5 )%
Other income (expense) recognized during the six months ended June 30, 2021
consisted primarily of interest income of $420,000 , partially offset by $41,000
of expenses relating to the amortization of certain financing costs. Other
income (expense) recognized during the six months ended June 30, 2020 consisted
primarily of interest income of $2.3 million , partially offset by $65,000 of
expenses relating to the amortization of certain financing costs.
Liquidity and Capital Resources
We have incurred losses and negative cash flows from operations and have not generated any revenues since our inception. As ofJune 30, 2021 , we had cash, cash equivalents and short-term investments of$228.3 million . As such, we believe our cash, cash equivalents and short-term investments will be sufficient to fund our operations through at leastSeptember 30, 2022 , 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 and VK5211, 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. OnJuly 11, 2018 , we filed with theSEC a universal Shelf Registration Statement on Form S-3 (File No. 333-226133), or the 2018 Shelf Registration Statement. The 2018 Shelf Registration Statement initially provided us with the ability to offer up to$450.0 million of securities, including equity, debt and other securities as described in the 2018 Shelf Registration Statement. The 2018 Shelf Registration Statement was declared effective by theSEC onJuly 19, 2018 and expired onJuly 19, 2021 . Pursuant to the 2018 Shelf Registration Statement, we could offer additional securities from time to time and through one or more methods of distribution, subject to market conditions and our capital needs. OnAugust 1, 2019 , we entered into an At-The-Market Equity Offering Sales Agreement, or the ATM Agreement, withStifel, Nicolaus & Company, Incorporated andOppenheimer & Co. Inc. , or, together, 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$75.0 million , or the ATM Shares. Any ATM Shares offered and sold in the ATM Offering were to be issued pursuant to the 2018 Shelf Registration Statement and the 424(b) prospectus supplement relating to the ATM Offering datedAugust 1, 2019 . The 2018 Shelf Registration Statement expired onJuly 19, 2021 . No shares of our common stock were sold under the ATM Agreement from its inception throughJune 30, 2021 . OnMarch 17, 2020 , our board of directors authorized a stock repurchase program, 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, or the Repurchase Program. The 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. ThroughJune 30, 2021 , no shares of our common stock or warrants to purchase our common stock were repurchased by us under the Repurchase Program. 25
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The following table summarizes our cash flows for the periods indicated below
(in thousands):
Six Months Ended June 30,
2021 2020
Cash used in operating activities $ (24,310 ) $ (10,968 )
Cash provided by (used in) investing activities $ (3,067 ) $ 20,932
Cash provided by financing activities $ 7,089 $ 449
Cash Used in Operating Activities
During the six months endedJune 30, 2021 , cash used in operating activities of$24.3 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. During the six months endedJune 30, 2020 , cash used in operating activities of$11.0 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 prepaid expenses, accounts payable and accrued expenses.
Cash Provided by (Used in) Investing Activities
During the six months endedJune 30, 2021 , cash used in investing activities of$3.1 million resulted primarily from the purchase of investments of$108.3 million , partially offset by the proceeds of sales and maturities of investments of$105.2 million . During the six months endedJune 30, 2020 , cash provided by investing activities of$20.9 million resulted primarily from the proceeds of sales and maturities of investments of$159.9 million , partially offset by the purchase of investments of$139.0 million .
Cash Provided by Financing Activities
During the six months endedJune 30, 2021 , cash provided by financing activities was$7.1 million , which consisted primarily of proceeds from certain warrant exercises of$7.1 million and proceeds from certain stock option exercises and ESPP purchases of$498,000 , partially offset by the value of shares withheld to cover taxes of$473,000 . During the six months endedJune 30, 2020 , cash provided by financing activities was$449,000 , which consisted primarily of proceeds from certain warrant exercises of$363,000 and proceeds from certain stock option exercises and ESPP purchases of$239,000 , partially offset by the value of shares withheld to cover taxes of$127,000 . 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, licensing
or other arrangements and the financial terms of such agreements;
• the timing of, and the costs involved in, obtaining regulatory approvals
for any of our current or future drug candidates;
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• the number and characteristics of the drug candidates we seek to develop
or commercialize;
• the cost of manufacturing clinical supplies, and establishing commercial
supplies, of our drug candidates;
• the cost of commercialization 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, should any of our drug candidates receive marketing approval;
• the impacts that the COVID-19 global pandemic may have on our business,
financial condition and results of operations, including disruptions to
our operations and clinical trials, as well as disruptions or delays with
respect to the operations of our service providers, suppliers and CROs;
and
• the costs involved in preparing, filing, prosecuting, maintaining,
defending and enforcing possible patent claims, including litigation costs
and the outcome of any such litigation.
Off-Balance Sheet Arrangements
As of
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