RENEO PHARMACEUTICALS, INC. 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 activities.
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. 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. We are
currently developing REN001 in rare genetic diseases that typically present with
myopathy, including PMM and long-chain fatty acid oxidation disorders (LC-FAOD).
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There are currently no approved therapies for the treatment of PMM, representing
a high unmet medical need with more than 66,000 and 82,000 patients with PMM in
the United States and Europe , respectively. There are approximately 5,000 and
more than 6,000 LC-FAOD patients in the United States and Europe , respectively.
We have received orphan drug designation from the U.S. Food and Drug
Administration (FDA) for REN001 for the treatment of PMM and LC-FAOD and Fast
Track designation for REN001 for treatment of PMM in the United States .
Additionally, we have received orphan drug designation for REN001 for treatment
of long-chain 3-hydroxy acyl-CoA dehydrogenase (LCHAD) and mitochondrial
encephalomyopathy, lactic acidosis, and neurological stroke-like episodes
(MELAS) in the European Union (EU).
We completed an open-label Phase 1b study in PMM patients with mitochondrial DNA
(mtDNA) 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 pivotal Phase 2b study of REN001 in adult PMM patients with
mtDNA (STRIDE). As of November 2022 , we have achieved over 80% enrollment on our
ongoing STRIDE study. We expect to complete enrollment of this pivotal trial in
the first quarter of 2023 and anticipate announcement of topline results in the
fourth quarter of 2023. We are also conducting a two-year, open-label, long-term
safety trial in PMM patients (STRIDE AHEAD) outside the United States . Following
our interactions with the FDA, European Medicines Agency (EMA), and several
other National regulatory agencies in Europe , we believe that positive results
from the ongoing pivotal STRIDE and STRIDE AHEAD studies could potentially
support registration of REN001 for PMM patients with mtDNA in the United States
and Europe . In addition, we are planning to study REN001 in PMM patients with
nuclear DNA (nDNA) defects.
We completed an open-label Phase 1b study in LC-FAOD patients with nuclear DNA
(nDNA) 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 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 (73.7 and 51.9 meters, respectively). We also
completed an observational, non-interventional study in LC-FAOD patients with
nDNA defects to better understand the natural history of LC-FAOD and changes in
patient function and symptoms over time (FORWARD). Results of the studies were
presented at the International Network of Fatty Acid Oxidation Research and
Management (INFORM) Conference in August 2022 . 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 LC-FAOD patients. We expect feedback
from the FDA in the first quarter of 2023 that will direct our regulatory
pathways for our LC-FAOD program.
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 $38.4 million and
$29.2 million for the nine months ended September 30, 2022 and 2021,
respectively. As of September 30, 2022 , we had an accumulated deficit of $123.1
million , and cash, cash equivalents and short-term investments of $116.1
million . We have funded our operations primarily through the issuance and sale
of equity securities.
In May 2022 , we entered into an at-the-market equity offering sales agreement
with SVB 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
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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, our expenditures
on other research and development, and commercialization 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 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 in the 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 of September 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 nine months endedSeptember 30, 2022 and 2021. 19 --------------------------------------------------------------------------------
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:
•
personnel expenses, including salaries, benefits, and stock-based compensation expense;
•
external expenses incurred under agreements with contract research organizations (CROs), investigative sites and consultants to conduct and support our preclinical studies and clinical trials;
•
raw materials related to manufacturing of our product candidate for clinical trials and preclinical studies, including fees paid to third-party manufacturers;
•
expenses related to regulatory activities, including filing fees paid to regulatory agencies;
•
facility costs including rent, depreciation, and maintenance expenses; and
•
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 Ended September 30, Nine Months Ended September 30,
2022 2021 2022 2021
Clinical and regulatory $ 5,555 $ 3,686 $ 14,143 $ 10,796
Contract manufacturing cost 2,469 2,570 6,802 5,035
Nonclinical 577 696 3,060 2,024
Research and development-other expense 1,337 2,366 3,343 3,214
Total $ 9,938 $ 9,318 $ 27,348 $ 21,069
We expect our research and development expenses to increase substantially for
the foreseeable future as we advance our product candidate through clinical
trials, continue to conduct preclinical studies and pursue regulatory approval
for 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:
•
the scope, rate of progress, expense and results of clinical trials and preclinical studies;
• per patient trial costs;
•
the number of trials required for approval;
•
the number of sites included in the trials;
•
the countries in which the trials are conducted;
•
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;
•
potential additional safety monitoring requested by regulatory agencies;
•
the duration of patient participation in the trials and follow-up;
•
the safety and efficacy of our product candidate;
•
the cost and timing of manufacturing our product candidates; and
•
the extent to which we establish strategic collaborations or other arrangements.
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 September 30,
2022 2021 Change
Operating expenses:
Research and development $ 9,938 $ 9,318 $ 620
General and administrative 3,902 3,434 468
Total operating expenses 13,840 12,752 1,088
Loss from operations (13,840 ) (12,752 ) (1,088 )
Other income 833 17 816
Net loss $ (13,007 ) $ (12,735 ) $ (272 ) Research and Development Expenses
Research and development expenses for the three months endedSeptember 30, 2022 were$9.9 million , compared to$9.3 million for the three months endedSeptember 30, 2021 . This increase of$0.6 million was primarily due to a$1.4 million increase in clinical study and manufacturing costs primarily related to our STRIDE study and a$0.8 million increase in personnel-related costs due to the additional headcount required to support our clinical and manufacturing operations, offset by a$1.5 million decrease in non-clinical activities.
General and Administrative Expenses
General and administrative expenses for the three months endedSeptember 30, 2022 were$3.9 million , compared to$3.4 million for the three months endedSeptember 30, 2021 . This increase of$0.5 million was primarily attributable to increased costs to operate as a public company, including increases in outside professional services of$0.8 million offset by a decrease in stock-based compensation of$0.4 million . 21 --------------------------------------------------------------------------------
Other Income
The increase in other income for the three months ended
Comparison of Nine Months Ended
The following table summarizes our results of operations (in thousands):
Nine Months Ended September 30,
2022 2021 Change
Operating expenses:
Research and development $ 27,348 $ 21,069 $ 6,279
General and administrative 11,938 8,125 3,813
Total operating expenses 39,286 29,194 10,092
Loss from operations (39,286 ) (29,194 ) (10,092 )
Other income 931 31 900
Net loss $ (38,355 ) $ (29,163 ) $ (9,192 ) Research and Development Expenses
Research and development expenses for the nine months endedSeptember 30, 2022 were$27.3 million , compared to$21.1 million for the nine months endedSeptember 30, 2021 . This increase of$6.3 million was primarily due to an increase of$4.0 million related to clinical trial and manufacturing costs associated with the launch of our STRIDE study as well as our Phase 1b clinical trials of LC-FAOD. In addition, there was a$2.7 million increase in personnel-related costs due to the additional headcount required to support our clinical and manufacturing operations offset by a$0.4 million decrease in non-clinical activities.
General and Administrative Expenses
General and administrative expenses for the nine months endedSeptember 30, 2022 were$11.9 million , compared to$8.1 million for the nine months endedSeptember 30, 2021 . This increase of$3.8 million was primarily attributable to increased costs to operate as a public company, including increases in outside professional services of$3.3 million , insurance premiums of$0.3 million , and personnel-related expenses of$0.2 million .
Other Income
The increase in other income for the nine 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$20.0 million in shares of our common stock. We have not yet sold any shares of our common stock under the ATM facility. 22 --------------------------------------------------------------------------------
Cash Flows
The following table summarizes our cash flows (unaudited and in thousands):
Nine Months
Ended
2022 2021
Net cash used in operating activities$ (31,749 ) $ (27,962 ) Net cash used in investing activities (30,925 ) (31,529 ) Net cash provided by financing activities 146 132,287
Net (decrease) increase in cash and cash equivalents
$ 72,796 Operating Activities Net cash used in operating activities for the nine months endedSeptember 30, 2022 was$31.7 million , consisting primarily of our net loss of$38.4 million adjusted for non-cash items of$3.0 million primarily due to stock-based compensation expense and a$3.6 million net change in operating assets and liabilities. The change in our net operating assets and liabilities was primarily due to an increase in accounts payable and accrued expenses of$2.8 million due to timing of receipt of invoices and payments and a decrease in prepaid and other current assets of$1.1 million . Net cash used in operating activities for the nine months endedSeptember 30, 2021 was$28.0 million , consisting primarily of our net loss of$29.2 million and a$1.7 million net decrease in operating assets and liabilities, partially offset by$2.9 million in non-cash charges primarily consisting of stock-based compensation expense. Investing Activities
Net cash used in investing activities for the nine months ended
Financing Activities
Net cash provided by financing activities for the nine months ended
Net cash provided by financing activities for the nine months endedSeptember 30, 2021 was$132.3 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$0.4 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:
•
the scope, progress, results and costs of clinical trials and preclinical studies for REN001;
•
the scope, prioritization and number of our research and clinical indications we pursue;
•
the costs and timing of manufacturing for our product candidates;
•
the costs, timing, and outcome of regulatory review of REN001;
•
the timing and amount of the milestone or other payments we must make to vTv Therapeutics and any future licensors;
•
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;
•
the extent to which we acquire or in-license other product candidates and technologies;
•
the costs of securing manufacturing arrangements for commercial production;
•
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
•
the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market any product candidates.
As ofSeptember 30, 2022 , we had$116.1 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 ofSeptember 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 24 -------------------------------------------------------------------------------- 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. 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 nine months endedSeptember 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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