You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements and notes thereto and the related Management's Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year endedDecember 31, 2021 . Unless otherwise indicated, all references in this Quarterly Report on Form 10-Q to "Reneo," the "company," "we," "our," "us" or similar terms refer toReneo Pharmaceuticals, Inc. and its subsidiary.
Forward-Looking Statements
In addition to historical financial information, this discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in the section titled "Risk Factors" under Part II, Item 1A below. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potentially," "predict," "should," "will" or the negative of these terms or other similar expressions. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Overview Reneo is a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, which are often associated with the inability of mitochondria to produce adenosine triphosphate (ATP). Our lead product candidate, REN001, is a potent and selective agonist of the peroxisome proliferator-activated receptor delta (PPAR?). REN001 has been shown to increase transcription of genes involved in mitochondrial function and increase fatty acid oxidation, and may increase production of new mitochondria. The PPAR family of nuclear hormone receptors, PPAR?, PPAR?, and PPAR?, control the transcription of genes critical for regulating energy metabolism and homeostasis. PPAR? is highly expressed in muscle, kidney, brain, and liver tissue. Activation of PPAR? results in changes in the expression of genes involved with multiple aspects of energy metabolism including uptake of fatty acids, utilization of fatty acids as an energy source, and mitochondrial biogenesis. Increases in PPAR? activity also correlate with a shift in muscle tissue towards oxidative, fat-consuming type I fibers that are associated with endurance as opposed to glycolytic, type II fibers. In preclinical and clinical studies, increased PPAR? activity through transgenic overexpression or pharmacological activation increases muscular strength and endurance across a variety of functional measures. REN001 was studied in healthy male volunteers with one leg immobilized to produce muscle atrophy. Compared to placebo, administration of REN001 resulted in statistically significant increases in expression of genes involved in mitochondrial oxidative phosphorylation, and statistically significant improvements in muscle strength. REN001 was also studied in an open-label trial in patients with primary mitochondrial myopathies (PMM). In this trial, administration of REN001 improved function, reduced symptoms, and increased expression of genes involved in mitochondrial activity. As a PPAR? agonist, REN001 may benefit patients with genetic mitochondrial myopathies who experience weakness, fatigue, or deterioration in muscle due to impaired mitochondrial energy production. We are currently developing REN001 in rare genetic diseases that typically present with myopathy and have high unmet medical needs, including PMM and long-chain fatty acid oxidation disorders (LC-FAOD). Patients with these diseases are unable to perform many everyday activities, can experience cardiomyopathy and other organ dysfunction, and typically have a reduced life expectancy. 17 -------------------------------------------------------------------------------- We completed an open-label Phase 1b study in PMM patients with mitochondrial DNA defects to assess the safety and tolerability of REN001, and measure changes in functional tests such as walk distance, exercise capacity and patient-reported symptoms that could serve as potential endpoints in future clinical studies. REN001 was well-tolerated and had an adequate safety profile in this trial. Compared to baseline, patients receiving REN001 once-daily for 12 weeks experienced an average increase in distance of 104.4 meters in the 12-minute walk test (12MWT), an average increase in weight-adjusted peak oxygen consumption (VO2) of 1.7 mL/kg/min, a reduction in fatigue and pain, and increased expression of genes involved with transport and metabolism of nutrients in the mitochondria including Pyruvate dehydrogenase lipoamide kinase isozyme 4 (PDK4), Angiopoietin-like 4 (ANGPTL4), and Solute carrier family 25 member 34 (SLC25A34). Based on these results, we initiated a global, randomized, double-blind, placebo-controlled Phase 2b study of REN001 in patients with PMM (STRIDE). We expect to complete enrollment by year-end 2022 and announce topline results in the second half of 2023. We are also conducting a two-year, open-label, long-term safety trial outsidethe United States (STRIDE AHEAD). Following our interactions with theU.S. Food and Drug Administration (FDA),European Medicines Agency (EMA), and several other European regulatory agencies, we believe that positive results from the ongoing STRIDE and STRIDE AHEAD studies could support registration of REN001 for adult PMM patients with mitochondrial DNA defects in boththe United States and inEurope . We completed an open-label Phase 1b study in LC-FAOD patients with nuclear DNA defects to assess the safety and tolerability of REN001, and measure changes in functional tests such as walk distance, exercise capacity and patient-reported symptoms that could serve as potential endpoints in future clinical studies. The study included patients with defective long-chain 3-hydroxy acyl-CoA dehydrogenase (LCHAD), carnitine palmitoyltransferase 2 (CPT2), very long-chain acyl-CoA dehydrogenase (VCLAD), or trifunctional protein (TFP). REN001 was well-tolerated and had an adequate safety profile in this trial. The LCHAD and CPT2 groups had the greatest improvement over baseline in 12MWT (73.3 and 51.9 meters, respectively). We also completed an observational, non-interventional study in LC-FAOD patients with nuclear DNA defects to better understand the natural history of LC-FAOD and changes in patient function and symptoms over time (FORWARD). Based on the results of the LC-FAOD Phase 1b study, in conjunction with the results of the FORWARD study, we intend to continue development of REN001 in patients with LC-FAOD. We do not own or operate manufacturing facilities. We rely, and expect to continue to rely, on third parties for the manufacture of REN001 for preclinical studies and clinical trials, as well as for commercial manufacturing if REN001 obtains marketing approval. We also rely, and expect to continue to rely, on third parties to manufacture, package, label, store, and distribute REN001, if marketing approval is obtained. We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment, and personnel while also enabling us to focus our expertise and resources on the development of REN001. Since our inception in 2014, our operations have primarily focused on raising capital, establishing and protecting our intellectual property portfolio, organizing and staffing our company, business planning, and conducting preclinical, clinical and manufacturing development for REN001. We do not have any product candidates approved for sale, have not generated any revenue from product sales, and do not expect to generate revenues from the commercial sale of our product candidate for several years, if ever. Since inception, we have incurred significant operating losses. Our net losses were$25.3 million and$16.4 million for the six months endedJune 30, 2022 and 2021, respectively. As ofJune 30, 2022 , we had an accumulated deficit of$110.1 million , and cash, cash equivalents and short-term investments of$126.9 million . We have funded our operations primarily through the issuance and sale of equity securities. InMay 2022 , we entered into an at-the-market equity offering sales agreement withSVB Securities LLC (ATM facility) under which we may offer and sell, from time to time at our sole discretion, up to$20.0 million in shares of our common stock. We have not yet sold any shares of our common stock under the ATM facility. We expect to continue to incur net operating losses for at least the next several years, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase as we conduct our ongoing and planned clinical trials and preclinical studies, engage in other research and development activities, seek regulatory approvals for any product candidates that successfully complete clinical trials, incur development milestone payments related to our research and development activities, prepare for commercialization, hire additional personnel, and protect our intellectual property. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities. As a result, we will need to raise additional capital. Until such time as we can generate significant revenue from sales of our product candidate, if ever, we expect to finance our operations 18 -------------------------------------------------------------------------------- through public or private equity offerings or debt financings, credit or loan facilities, collaborations, strategic alliances, licensing arrangements or a combination of one or more of these funding sources. Additional funds may not be available to us on acceptable terms or at all. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, the credit and financial markets inthe United States and worldwide, including those resulting from the ongoing COVID-19 pandemic, as well as actual or perceived changes in interest rates and economic inflation. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations. Based upon our current operating plan, we believe that our cash, cash equivalents, and short-term investments as ofJune 30, 2022 will enable us to fund our operating expenses and capital expenditure requirements into 2024.
COVID-19
The COVID-19 pandemic continues to evolve, and we will continue to monitor the COVID-19 situation closely. The extent of the impact of COVID-19 on our business, operations and clinical development timelines and plans remains uncertain, and will depend on certain developments, including the duration and spread of the pandemic, including new variants of the virus, and its impact on our clinical trial enrollment, trial sites, contract research organizations, third-party manufacturers, and other third parties with whom we do business, as well as its impact on regulatory authorities and our key scientific and management personnel. For example, our Phase 1b study of REN001 in PMM patients was closed early as a result of COVID-19, and we may face future clinical trial disruptions. The ultimate impact of the COVID-19 pandemic or a similar health epidemic is highly uncertain and subject to change. As a result of COVID-19, we have taken precautionary measures in order to minimize the risk of the virus to our employees and the communities in which we operate. While we have experienced impacts to our clinical development activities as a result of COVID-19, there has been minimal disruption to date in our ability to ensure the effective operation of our business. We will continue to actively monitor the evolving situation related to COVID-19 and may take further actions that alter our operations, including those that may be required by federal, state or local authorities, or that we determine are in the best interests of our employees and other third parties with whom we do business. At this point, the extent to which the COVID-19 pandemic may affect our business, operations and clinical development timelines and plans, including the resulting impact on our expenditures and capital needs, remains uncertain.
License Agreement
InDecember 2017 , we entered into a License Agreement with vTvTherapeutics LLC (vTv Therapeutics) (the vTv License Agreement), under which we obtained an exclusive, worldwide, sublicensable license under certain vTv Therapeutics intellectual property to develop, manufacture and commercialize PPAR? agonists and products containing such PPAR? agonists, including REN001, for any therapeutic, prophylactic or diagnostic application in humans. Under the terms of the vTv License Agreement, we paid vTv Therapeutics an initial upfront license fee of$3.0 million and$2.0 million of milestone payments and issued an aggregate of 576,443 shares of our common stock to vTv Therapeutics. Upon the achievement of certain pre-specified development and regulatory milestones, we are also required to pay vTv Therapeutics milestone payments totaling up to$64.5 million . We are also required to pay vTv Therapeutics up to$30.0 million in total sales-based milestones upon achievement of certain sales thresholds of the licensed product. In addition, we are obligated to make tiered royalty payments to vTv Therapeutics at mid-single digit to low teen percentage royalty rates, based on tiers of annual net sales of licensed products, subject to certain customary reductions. There were no milestone payments achieved or recorded for the three and six months endedJune 30, 2022 and 2021.
Components of Our Results of Operations
Operating Expenses
Research and Development Expenses
To date, our research and development expenses have primarily related to preclinical and clinical development of REN001. Research and development expenses include:
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personnel expenses, including salaries, benefits, and stock-based compensation expense;
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external expenses incurred under agreements with contract research organizations (CROs), investigative sites and consultants to conduct and support our preclinical studies and clinical trials;
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raw materials related to manufacturing of our product candidate for clinical trials and preclinical studies, including fees paid to third-party manufacturers;
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expenses related to regulatory activities, including filing fees paid to regulatory agencies;
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facility costs including rent, depreciation, and maintenance expenses; and
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fees for maintaining licenses under our third-party licensing agreements.
Research and development expenses are recognized as incurred and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received. Costs for certain activities, such as manufacturing and preclinical studies and clinical trials, are generally recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and collaborators. We expense amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain and the technology has no alternative future use when acquired.
The following table summarizes our research and development expenses (in thousands):
Three Months EndedJune 30 ,
Six Months Ended
2022 2021 2022 2021 Clinical and regulatory$ 3,877 $ 3,839 $ 8,588 $ 7,111 Contract manufacturing cost 1,994 1,224 4,333 2,465 Nonclinical 1,091 765 2,483 1,328 Research and development-other expense 1,170 451 2,006 847 Total$ 8,132 $ 6,279 $ 17,410 $ 11,751 We expect our research and development expenses to increase substantially for the foreseeable future as we advance our product candidate into and through clinical trials, continue to conduct preclinical studies and pursue regulatory approval of our product candidate. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our product candidate may be affected by a variety of factors including: the safety and efficacy of our product candidate, early clinical data, investment in our clinical program, competition, manufacturing capability and commercial viability. We may never succeed in achieving regulatory approval for our product candidate. As a result of the uncertainties discussed above, at this time we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of and obtain regulatory approval for our product candidate. Our research and development costs may vary significantly based on factors such as:
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the scope, rate of progress, expense and results of clinical trials and preclinical studies;
• per patient trial costs;
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the number of trials required for approval;
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the number of sites included in the trials;
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the countries in which the trials are conducted;
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the number of patients that participate in the trials;
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uncertainties in patient enrollment or drop out or discontinuation rates, particularly in light of the current COVID-19 pandemic environment;
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potential additional safety monitoring requested by regulatory agencies;
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the duration of patient participation in the trials and follow-up;
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the safety and efficacy of our product candidate;
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the cost and timing of manufacturing our product candidates; and
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the extent to which we establish strategic collaborations or other arrangements.
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General and Administrative Expenses
General and administrative expenses consist primarily of personnel expenses, including salaries, benefits, and stock-based compensation expense, for personnel in executive, finance, accounting, and human resource and other administrative functions. General and administrative expenses also include corporate facility costs not otherwise included in research and development expenses, legal fees related to intellectual property and corporate matters, insurance costs and fees for accounting and consulting services.
We expect our general and administrative expenses to increase for the foreseeable future to support continued research and development activities, including our ongoing and planned research and development of our product candidate for multiple indications.
Other Income
Other income consists of interest income on our cash, cash equivalents, and short-term investments.
Results of Operations
Comparison of Three Months Ended
The following table summarizes our results of operations (in thousands):
Three Months Ended June 30, 2022 2021 Change Operating expenses: Research and development $ 8,132$ 6,279 $ 1,853 General and administrative 4,299 2,949 1,350 Total operating expenses 12,431 9,228 3,203 Loss from operations (12,431 ) (9,228 ) (3,203 ) Other income 119 12 107 Net loss$ (12,312 ) $ (9,216 ) $ (3,096 )
Research and Development Expenses
Research and development expenses for the three months endedJune 30, 2022 were$8.1 million , compared to$6.3 million for the three months endedJune 30, 2021 . This increase of$1.8 million was primarily due to a$1.1 million increase in personnel-related costs due to the additional headcount required to support our clinical and manufacturing operation. In addition, there was a$0.4 million increase in clinical trial and manufacturing costs and a$0.4 million increase in non-clinical activities.
General and Administrative Expenses
General and administrative expenses for the three months endedJune 30, 2022 were$4.3 million , compared to$2.9 million during the three months endedJune 30, 2021 . This increase of$1.4 million was primarily attributable to increased costs to operate as a public company, including increases in outside professional services of$1.1 million and personnel-related expenses of$0.1 million . Other Income
Other income for the three months ended
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Comparison of Six Months Ended
The following table summarizes our results of operations (in thousands):
Six Months Ended June 30, 2022 2021 Change Operating expenses: Research and development$ 17,410 $ 11,751 $ 5,659 General and administrative 8,036 4,691 3,345 Total operating expenses 25,446 16,442 9,004 Loss from operations (25,446 ) (16,442 ) (9,004 ) Other income 98 14 84 Net loss$ (25,348 ) $ (16,428 ) $ (8,920 )
Research and Development Expenses
Research and development expenses for the six months endedJune 30, 2022 were$17.4 million , compared to$11.8 million for the six months endedJune 30, 2021 . This increase of$5.7 million was primarily due to an increase of$2.6 million related to clinical trial and manufacturing costs associated with the launch of our STRIDE and FORWARD studies as well as our Phase 1b clinical trials of LC-FAOD. In addition, there was a$1.9 million increase in personnel-related costs due to the additional headcount required to support our clinical and manufacturing operations and a$1.1 million increase in non-clinical activities.
General and Administrative Expenses
General and administrative expenses for the six months ended
Other Income
Other income for the six months ended
Liquidity and Capital Resources
Since inception, we have incurred operating losses and negative cash flows from operations and have funded our operations primarily through the sale of preferred and common stock. We do not have any product candidates approved for sale and have not generated any revenue from product sales, and we do not expect to generate revenues from the commercial sale of our product candidate for at least the foreseeable future, if ever. We are subject to all the risks related to the development and commercialization of novel therapeutics, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business. We continue to incur additional costs associated with operating as a public company. We anticipate that we will need substantial additional funding in connection with our continuing operations. InMay 2022 , we entered into the ATM facility under which we may offer and sell, from time to time at our sole discretion, up to$20.0 million in shares of our common stock. We have not yet sold any shares of our common stock under the ATM facility. Cash Flows
The following table summarizes our cash flows (unaudited and in thousands):
Six Months Ended
2022
2021
Net cash used in operating activities$ (20,955 ) $ (18,290 ) Net cash provided by (used in) investing activities 14,510 (27,020 ) Net cash provided by financing activities 49
132,065
Net (decrease) increase in cash and cash equivalents
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Operating Activities Net cash used in operating activities for the six months endedJune 30, 2022 was$21.0 million , consisting primarily of our net loss of$25.3 million adjusted for non-cash items of$2.0 million primarily due to stock-based compensation expense and$2.4 million net change in operating assets and liabilities. The change in our net operating assets and liabilities was primarily due to an increase in accrued expenses of$1.7 million due to timing of receipt of invoices and payments and a decrease in prepaid and other current assets of$0.9 million . Net cash used in operating activities for the six months endedJune 30, 2021 was$18.3 million , consisting primarily of our net loss of$16.4 million and a$3.6 million net decrease in operating assets and liabilities, partially offset by$1.7 million in non-cash charges primarily consisting of stock-based compensation expense.
Investing Activities
Net cash provided by investing activities for the six months ended
Net cash used in investing activities for the six months ended
Financing Activities
Net cash provided by financing activities for the six months ended
Net cash provided by financing activities for the six months endedJune 30, 2021 was$132.1 million , consisting primarily of$84.6 million of net proceeds from our initial public offering (IPO),$47.4 million of net proceeds from the issuance of Series B convertible preferred stock, and$0.2 million of proceeds from the exercise of stock options.
Funding Requirements
We will need to raise additional capital through public or private equity offerings or debt financings, credit or loan facilities, collaborations, strategic alliances, licensing arrangements or a combination of one or more of these funding sources. Additional funds may not be available to us on acceptable terms or at all. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, the credit and financial markets inthe United States and worldwide, including those resulting from the ongoing COVID-19 pandemic, as well as actual or perceived changes in interest rates and economic inflation. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
Our future capital requirements will depend on many factors, including:
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the scope, progress, results and costs of clinical trials and preclinical studies for REN001;
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the scope, prioritization and number of our research and clinical indications we pursue;
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the costs and timing of manufacturing for our product candidates;
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the costs, timing, and outcome of regulatory review of REN001;
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the timing and amount of the milestone or other payments we must make to vTv Therapeutics and any future licensors;
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the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements;
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the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
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the extent to which we acquire or in-license other product candidates and technologies;
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the costs of securing manufacturing arrangements for commercial production;
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our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; and
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the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market any product candidates.
As ofJune 30, 2022 , we had$126.9 million in cash, cash equivalents and short-term investments. We believe, based upon our current operating plan, that our cash, cash equivalents and short-term investments as ofJune 30, 2022 will be sufficient to fund our planned operations into 2024. Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive, and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidate, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of a product candidate that we do not expect to be commercially available for many years, if at all. Until such time as we can generate significant revenue from sales of our product candidate, if ever, we expect to finance our operations through public or private equity offerings or debt financings, credit or loan facilities, collaborations, strategic alliances, licensing arrangements or a combination of one or more of these funding sources. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidate that we would otherwise prefer to develop and market ourselves. Material Cash Requirements
The discussion below summarizes our significant contractual obligations and
commitments as of
Leases. See Note 6 of Notes to Consolidated Financial Statements included in this Quarterly Report on Form 10-Q for information, including the future operating lease minimum payments.
Performance Award. See Note 8 of Notes to Consolidated Financial Statements included in this Quarterly Report on Form 10-Q for information, including the maximum payout.
vTv License Agreement. See Note 9 of Notes to Consolidated Financial Statements included in this Quarterly Report on Form 10-Q for information, including the milestone payments, associated with the vTv License Agreement.
In addition to contractual obligations above, we also expect to have future material cash requirements related to our contract manufacturing, preclinical and clinical programs, personnel expenses, and commercialization activities.
Critical Accounting Policies and Estimates
Our management's discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted inthe United States of America . The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe to be 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 materially from these estimates under different assumptions or conditions. 24 -------------------------------------------------------------------------------- Our critical accounting policies are described in the section titled "Management's Discussion and Analysis of Financial Condition and Results of Operations-Critical Accounting Policies and Estimates" in our Annual Report on Form 10-K for the year endedDecember 31, 2021 , and the notes to our consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the six months endedJune 30, 2022 , there were no material changes to our critical accounting policies from those discussed in our Annual Report on Form 10-K for the year endedDecember 31, 2021 .
Recent Accounting Pronouncements
See Note 2 of Notes to Consolidated Financial Statements included in this Quarterly Report on Form 10-Q for a description of recent accounting pronouncements applicable to our consolidated financial statements.
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