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 ended
December 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 to Reneo 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.

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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 outside the United States (STRIDE AHEAD). Following our
interactions with the U.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 both the United States and in Europe.

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 ended June 30, 2022 and 2021, respectively. As
of June 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.

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 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

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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 June 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



In December 2017, we entered into a License Agreement with vTv Therapeutics 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 ended June 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:

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;


                                       19
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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;

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 June 30,   

Six Months Ended June 30,


                                               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:

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;

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.


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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 June 30, 2022 and 2021 (Unaudited)

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 ended June 30, 2022 were
$8.1 million, compared to $6.3 million for the three months ended June 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 ended June 30, 2022
were $4.3 million, compared to $2.9 million during the three months ended June
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 June 30, 2022 and 2021 was immaterial.


                                       21
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Comparison of Six Months Ended June 30, 2022 and 2021 (Unaudited)

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 ended June 30, 2022 were
$17.4 million, compared to $11.8 million for the six months ended June 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 June 30, 2022 were $8.0 million, compared to $4.7 million during the six months ended June 30, 2021. This increase of $3.3 million was primarily attributable to increased costs to operate as a public company, including increases in outside professional services of $1.7 million, personnel-related expenses of $0.5 million, and insurance premiums of $0.3 million.

Other Income

Other income for the six months ended June 30, 2022 and 2021 was immaterial.

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.

In May 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 

June 30,


                                                           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 $ (6,396 ) $ 86,755






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Operating Activities

Net cash used in operating activities for the six months ended June 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 ended June 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 June 30, 2022 was $14.5 million which was transferred to cash and cash equivalents, and consisted primarily of the proceeds from maturities of available-for-sale short-term investments of $30.5 million offset by the purchase of available-for-sale short-term investments of $15.9 million.

Net cash used in investing activities for the six months ended June 30, 2021 was $27.0 million consisting primarily of the purchase of available-for-sale short-term investments.

Financing Activities

Net cash provided by financing activities for the six months ended June 30, 2022 was immaterial.



Net cash provided by financing activities for the six months ended June 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 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.

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;

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;


                                       23
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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

the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market any product candidates.



As of June 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 of June 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 June 30, 2022.

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 in the
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.

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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 ended December 31, 2021, and the notes to our
consolidated financial statements appearing elsewhere in this Quarterly Report
on Form 10-Q. During the six months ended June 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 ended December 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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