The following discussion and analysis of our financial condition and results of
operations should be read in conjunction with our unaudited financial statements
and related notes included in this Quarterly Report on Form
10-Q
and the audited financial statements and notes thereto as of and for the year
ended December 31, 2020 and the related Management's Discussion and Analysis of
Financial Condition and Results of Operations, included in our final prospectus
dated June 30, 2021 and filed with the Securities and Exchange Commission (the
"SEC"), on July 2, 2021, pursuant to Rule 424(b)(4) under the Securities Act of
1933, as amended (the "Securities Act"). This discussion, particularly
information with respect to our future results of operations or financial
condition, business strategy, plans and objectives of management for future
operations and the potential impact that the ongoing
COVID-19
pandemic may have on our business, includes forward-looking statements that
involve risks and uncertainties as described under the heading "Special Note
Regarding Forward-Looking Statements" in this Quarterly Report on Form
10-Q.
You should review the disclosure under the heading "Risk Factors" in this
Quarterly Report on Form
10-Q
for a discussion of important factors that could cause our actual results to
differ materially from those anticipated in these forward-looking statements.
Overview
We are a clinical-stage biopharmaceutical company developing a novel
disease-modifying approach to target what we believe to be a key underlying
cause of Alzheimer's disease (AD). Alzheimer's disease is a progressive
neurodegenerative disease of the brain that leads to loss of memory and
cognitive functions and ultimately results in death. Our scientific founders
pioneered research on soluble amyloid-beta oligomers ("AßOs"), globular
assemblies of the amyloid-beta ("Aß") peptide that are distinct from other forms
of Aß and amyloid. We are currently focused on advancing a targeted
immunotherapy drug candidate, ACU193, through clinical proof of mechanism in
early AD patients. We initiated our Phase 1 clinical trial of ACU193 in the
second quarter of 2021.
We were incorporated in 1996 and were party to an exclusive license and research
collaboration with Merck in 2003. Although we acquired the exclusive rights to
ACU193 from Merck in 2011 following Merck's strategic decision to focus its AD
development efforts on a different product candidate, we did not recommence
meaningful operations until we completed our first institutional fundraising in
2018. Since 2018, we have devoted substantially all of our efforts to organizing
and staffing our company, business planning, raising capital, conducting
discovery, research and development activities, and providing general and
administrative support for these operations. We do not have any products
approved for sale and have not generated any revenue from product sales. We have
funded our operations primarily through the sale of our convertible preferred
stock and common stock, the issuance of notes, grant revenue and during our
collaboration with Merck, certain payments received under our collaboration
agreement.
From inception through June 30, 2021, we raised an aggregate of $99.4 million of
gross proceeds through the issuance of convertible preferred stock, as well as
sales of common stock and issuance of notes that were converted to preferred
stock, with the vast majority of this capital being raised since our Series
A-1
convertible preferred stock, or Series
A-1,
financing in 2018. In 2020, we conducted a Series B convertible preferred stock,
or Series B, financing, with the funding to occur in two tranches. We closed the
first tranche of the Series B financing in November 2020, selling 11,862,043
shares of Series B at $3.80 per share for gross proceeds of $45.1 million. On
June 9, 2021, our board of directors and the holders of more than 67% of the
outstanding shares of Series B preferred stock elected to waive the achievement
of the milestone event. On June 17, 2021, we closed the second tranche of our
Series B preferred stock financing, pursuant to which certain of our investors
funded an additional $30.0 million.
We have incurred net losses and negative cash flows from operations since our
inception. Our net loss was $88.4 million and $7.3 million for the six months
ended June 30, 2021 and the year ended December 31, 2020, respectively. As of
June 30, 2021, we had an accumulated deficit of $115.3 million. Our net losses
and cash flows from operations may fluctuate significantly from
quarter-to-quarter
and
year-to-year,
depending on the timing of nonclinical studies, clinical trials and our
expenditures on other research and development activities. We expect our
expenses and operating losses will increase substantially for the foreseeable
future as we advance ACU193 into clinical trials, seek to expand our product
candidate portfolio through developing additional product candidates, grow our
clinical, regulatory and quality capabilities, and incur additional costs
associated with operating as a public

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company. It is likely that we will seek third-party collaborators for the future
commercialization of ACU193 or any other product candidate that is approved for
marketing. However, we may seek to commercialize our products at our own
expense, which would require us to incur significant additional expenses for
marketing, sales, manufacturing and distribution.
We will not generate revenue from product sales unless and until we successfully
complete clinical development and obtain regulatory approval for our product
candidates. In addition, if we obtain regulatory approval for our product
candidates and do not enter into a third-party commercialization partnership, we
expect to incur significant expenses related to developing our commercialization
capability to support product sales, marketing, manufacturing and distribution
activities.
As a result, we will need substantial additional funding to support our
continuing operations and pursue our growth strategy. Until we can generate
significant revenue from product sales, if ever, we expect to finance our
operations through a combination of public or private equity offerings and debt
financings or other sources, such as potential collaboration agreements,
strategic alliances and licensing arrangements. We may be unable to raise
additional funds or enter into such other agreements or arrangements when needed
on acceptable terms, or at all. Our failure to raise capital or enter into such
agreements as, and when needed, could have a material adverse effect on our
business, results of operations and financial condition.
As of June 30, 2021, we had cash and cash equivalents of $68.8 million. In July
2021, we raised an additional $168.6 million in net proceeds from our IPO. Based
on our current operating plan, we expect that the net proceeds from our IPO,
together with our existing cash and cash equivalents as of June 30, 2021, will
be sufficient to enable us to fund our operating expenses and capital
expenditure requirements at least through 2024. We have based this estimate on
assumptions that may prove to be wrong, and we could exhaust our available
capital resources sooner than we expect. See "-Liquidity and Capital Resources."
COVID-19
Business Update
In March 2020, the World Health Organization declared
COVID-19
a global pandemic and the United States declared a national emergency with
respect to
COVID-19.
In response to the
COVID-19
pandemic, a number of governmental orders and other public health guidance
measures have been implemented across much of the United States, including in
the locations of our office, clinical trial sites and third parties on whom we
rely. We implemented a work-from-home policy allowing employees and consultants
who can work from home to do so. Business travel has been limited, and online
video and teleconference technology is used to meet virtually rather than in
person. We have taken measures to secure our research and development
activities, while work in laboratories by our partners has been organized to
reduce risk of
COVID-19
transmission. Although to date, our business has not been materially impacted by
COVID-19,
it is possible that our clinical development timelines could be negatively
affected by
COVID-19,
which could materially and adversely affect our business, financial condition
and results of operations.
Components of Results of Operations
Grants and Other Revenue
To date, we have not generated any revenues from the commercial sale of any
products, and we do not expect to generate revenues from the commercial sale of
any products for the foreseeable future, if ever. For the years ended
December 31, 2019 and 2020, we derived revenue from a grant awarded by the
National Institutes of Health in September 2017 and renewed annually in 2018
through 2020. The grant provides us with funding to support the completion of
preclinical chemistry, manufacturing and control studies, toxicology and
pharmacokinetic studies, submit an IND dossier to the FDA, and then conduct
first in human clinical safety trials for ACU193. We recognize revenue from this
grant when the related costs are incurred and the right to payment is realized.
As of December 31, 2020, we had been awarded a total of $3.9 million under this
grant, all of which has been recognized as revenue prior to or during the years
ended December 31, 2019 and 2020.

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Operating Expenses
Our operating expenses consist of (i) research and development expenses and
(ii) general and administrative expenses.
Research and Development Expenses
Research and development costs primarily consist of direct costs associated with
consultants and materials, biologic storage, third party, contract research
organization costs and contract development and manufacturing expenses, salaries
and other personnel-related expenses. Research and development costs are
expensed as incurred. More specifically, these costs include:

         •   costs of funding research performed by third parties that conduct
             research and development and nonclinical and clinical activities on
             our behalf;



  •   costs of manufacturing drug supply and drug product;



         •   costs of conducting nonclinical studies and clinical trials of our
             product candidates;



         •   consulting and professional fees related to research and development
             activities, including equity-based compensation to
             non-employees;



  •   costs related to compliance with clinical regulatory requirements; and



         •   employee-related expenses, including salaries, benefits and
             stock-based compensation expense for our research and development
             personnel.

Costs for certain activities are recognized based on an evaluation of the progress to completion of specific tasks using data such as information provided to us by our vendors and analyzing the progress of our nonclinical and clinical studies or other services performed. Significant judgment and estimates are made in determining the accrued expense balances at the end of any reporting period. Advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered. As we currently only have one product candidate, ACU193, in development, we do not separately track expenses by program. Further, as we have historically relied exclusively on consultants for research and development activities, we did not have any material internal research and development costs for the year ended December 31, 2020 or for the six months ended June 30, 2021. We expect that our research and development expenses will increase substantially in connection with our clinical development activities for our ACU193 program. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of, or obtain regulatory



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Table of Contents approval for, any of our current or future product candidates. This is due to the numerous risks and uncertainties associated with product development and commercialization, including the following:



  •   our ability to add and retain key research and development personnel;



         •   our ability to successfully develop, obtain regulatory approval for,
             and then successfully commercialize our product candidates;



         •   our successful enrollment in and completion of clinical trials,
             including our ability to generate positive data from any such trials;



         •   the size and cost of any future clinical trials for existing or future
             product candidates in our pipeline;



         •   the costs associated with the development of any additional programs
             we identify
             in-house
             or acquire through collaborations and other arrangements and the
             success of such collaborations;



         •   the terms and timing of any additional collaborations, license or
             other arrangement, including the timing of any payments thereunder;



         •   our ability to establish and maintain agreements and operate with
             third-party manufacturers for clinical supply for our clinical trials
             and commercial manufacturing, if any of our product candidates are
             approved;



         •   costs related to manufacturing of our product candidates or to account
             for any future changes in our manufacturing plans;



         •   our ability to obtain and maintain patents, trade secret and other
             intellectual property protection and regulatory exclusivity for our
             product candidates, both in the United States and internationally;



         •   our ability to obtain and maintain third-party insurance coverage and
             adequate reimbursement for our product candidates, if and when
             approved;



         •   the acceptance of our product candidates, if approved, by patients,
             the medical community and third-party payors;



         •   effectively competing with other products if our product candidates
             are approved;



         •   the impact of any business interruptions to our operations, including
             the timing and enrollment of patients in our planned clinical trials,
             or to those of our manufacturers, suppliers, or other vendors
             resulting from the
             COVID-19
             pandemic or similar public health crisis; and



         •   our ability to maintain a continued acceptable safety profile for our
             therapies following approval.


A change in the outcome of any of these variables with respect to the
development of our product candidates could significantly change the costs and
timing associated with the development of that product candidate. We may never
succeed in obtaining regulatory approval for any of our product candidates.
General and Administrative Expenses
General and administrative expenses consist primarily of management and business
consultants and other related costs, including stock-based compensation. General
and administrative expenses also include board of directors' expenses and
professional fees for legal, patent, consulting, accounting, auditing, tax
services and insurance costs.
We expect that our general and administrative expenses will increase as our
organization and headcount needed in the future grows to support continued
research and development activities and potential commercialization of our
product candidates. These increases will likely include increased costs related
to the hiring of additional personnel and fees to outside consultants, attorneys
and accountants, among other expenses. Additionally, we expect to incur
increased expenses associated with being a public company, including costs of
additional personnel, accounting, audit, legal, regulatory
and tax-related services
associated with maintaining compliance with exchange listing and SEC
requirements, director and officer insurance costs, and investor and public
relations costs.
Other Income (Expense)
Other income (expense) primarily includes changes in fair value of the
Series A-1 warrant
liability and the Series B tranche rights, other income and interest income,
net.

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The
Series A-1 warrant
was issued in October 2018 in connection with the
Series A-1 preferred
financing. The warrant liability met the definition of a freestanding financial
instrument, as it was legally detachable and separately exercisable from the
initial closing of the
Series A-1 convertible
preferred stock. The warrant liability was initially recorded at fair value as a
liability on our balance sheet and was
subsequently re-measured at
fair value at the end of each reporting period and upon its exercise on June 22,
2021. The changes in the fair value were recognized as a component of other
income (expense).
Included in the terms of the Series B stock purchase agreement in November 2020
were tranche rights granted to the holders of the Series B convertible preferred
stock. The tranche rights provide the Series B holders with the right to
purchase additional shares of Series B at $3.80 per share in an additional
tranche after the achievement of a certain milestone event. On June 17, 2021 we
closed the second tranche of our Series B preferred stock financing upon the
election of a majority of the Series B investors, pursuant to which certain of
our investors funded an additional $30.0 million. The tranche rights met the
definition of a freestanding financial instrument as the tranche rights were
legally detachable and separately exercisable from the Series B convertible
preferred stock. The tranche rights were initially recorded at fair value as a
liability on our balance sheet. The tranche rights were
subsequently re-measured at
fair value at the end of each reporting period and at settlement. Changes in the
fair value were recognized as a component of other income (expense).
Results of Operations
Comparison of the Three Months Ended June 30, 2021 and 2020
The following table summarizes our results of operations for the three months
ended June 30, 2021 and 2020 (in thousands):

                                                Three Months Ended June 30,
                                                  2021                 2020              Change
Grant and other revenue                      $           -          $       151        $      (151 )

Costs and operating expenses
Research and development                              2,254               1,927                327
General and administrative                            1,187                 259                928

Total operating expenses                              3,441               2,186              1,255

Loss from operations                                 (3,441 )            (2,035 )           (1,406 )

Other income (expense)
Interest income                                           4                  -                   4
Change in fair value of preferred stock
tranche rights liability and preferred
stock warrant liability                             (57,940 )                -             (57,940 )
Other income                                             19                  -                  19

Total other income (expense)                        (57,917 )                -             (57,917 )

Net loss                                     $      (61,358 )       $    (2,035 )      $   (59,323 )



Grant and Other Revenue
Revenue related to our NIH grant was nil and $0.2 million for the three months
ended June 30, 2021 and 2020, respectively. Revenue under the NIH grant is
recognized when the related costs were incurred and the right to payment was
realized.
Research and Development Expenses
Research and development expenses were $2.3 million and $1.9 million for the
three months ended June 30, 2021 and 2020, respectively. The $0.3 million
increase was primarily due to increases in costs for contract research
organizations and personnel of $0.9 million and $0.5 million, respectively, net
of decreases in costs for consulting and drug safety testing of $0.6 million and
$0.5 million, respectively.
General and Administrative Expenses
General and administrative expenses were $1.2 million and $0.3 million for the
three months ended June 30, 2021 and 2020, respectively. The $0.9 million
increase was primarily due to increased accounting expenses incurred of
$0.4 million in anticipation of becoming a public company and increased
personnel expenses of $0.4 million due to employees hired during the first three
months of 2021. The remainder of the increase relates to increases for marketing
and public relations costs and rent expense.

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Other Income (Expense)
Increases in the fair value of the Series B tranche liability and the Series
A-1
warrant liability of $54.6 million and $3.3 million, respectively, were
primarily responsible for total other expense for the three months ended
June 30, 2021. Other income (expense) was nil for the three months ended
June 30, 2020.
Comparison of the Six Months Ended June 30, 2021 and 2020
The following table summarizes our results of operations for the six months
ended June 30, 2021 and 2020 (in thousands):

                                                 Six Months Ended June 30,
                                                  2021                2020              Change
Grant and other revenue                       $          -         $       377        $      (377 )

Costs and operating expenses
Research and development                              4,832              3,977                855
General and administrative                            2,402                481              1,921

Total operating expenses                              7,234              4,458              2,776

Loss from operations                                 (7,234 )           (4,081 )           (3,153 )

Other income (expense)
Interest income                                           8                  1                  7
Change in fair value of preferred stock
tranche rights liability and preferred
stock warrant liability                             (81,157 )               -             (81,157 )
Other income                                             28                 -                  28

Total other income (expense)                        (81,121 )                1            (81,122 )

Net loss                                      $     (88,355 )      $    (4,080 )      $   (84,275 )



Grant and Other Revenue
Revenue related to our NIH grant was nil and $0.4 million for the three months
ended June 30, 2021 and 2020, respectively. Revenue under the NIH grant is
recognized when the related costs were incurred and the right to payment was
realized.
Research and Development Expenses
Research and development expenses were $4.8 million and $4.0 million for the six
months ended June 30, 2021 and 2020, respectively. The $0.8 million increase was
primarily due to increases in costs for contract research organizations and
personnel of $1.7 million and $1.0 million, respectively, net of decreases in
costs for drug safety testing and consulting of $1.1 million and $0.5 million,
respectively, and a $0.2 million decrease for materials.
General and Administrative Expenses
General and administrative expenses were $2.4 million and $0.5 million for the
six months ended June 30, 2021 and 2020, respectively. The $1.9 million increase
was primarily due to increased accounting expenses incurred of $0.9 million in
anticipation of becoming a public company, increased personnel expenses of
$0.9 million due to employees hired during the first three months of 2021 and
increased marketing and public relations expenses of $0.1 million.
Other Income (Expense)
Increases in the fair value of the Series B tranche liability and the Series
A-1
warrant liability of $76.2 million and $5.0 million, respectively, were
primarily responsible for total other expense for the six months ended June 30,
2021. Other income (expense) was de minimis for the six months ended June 30,
2020.

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Liquidity and Capital Resources
Sources of Liquidity
Since our inception up until the time of our IPO in July 2021, we have funded
our operations primarily through the sale of our convertible preferred stock and
common stock, the issuance of notes, grant revenue and, during our collaboration
with Merck, certain payments received under our collaboration agreement. We do
not have any products approved for sale and have not generated any revenue from
product sales. From inception through June 30, 2021, we have raised an aggregate
of $99.4 million of gross proceeds through the issuance of convertible preferred
stock, as well as sales of common stock and issuance of notes that were
converted to preferred stock, with the vast majority of this capital being
raised since our Series
A-1 financing
in 2018. In 2020, we conducted a Series B financing, with the funding to occur
in two tranches. We closed the first tranche of the Series B financing in
November 2020 for gross proceeds of $45.1 million and the second tranche closed
on June 17, 2021 for gross proceeds of $30.0 million following the election of
our board of directors and a majority of the Series B investors to waive the
requirement for a certain milestone event for ACU193 to be achieved prior to
funding the second tranche on June 9, 2021. As of June 30, 2021, our cash and
cash equivalents totaled $68.8 million.
On July 6, 2021, we issued 9,999,999 shares of common stock in our IPO, and on
July 8, 2021, we issued an additional 1,499,999 shares of common stock that were
purchased by the underwriters pursuant to the underwriters' option to purchase
additional shares at the public offering price less underwriting discounts and
commissions. The price to the public for each share was $16.00. The aggregate
net proceeds from our IPO, after underwriting discounts and commissions and
other offering expenses of $15.4 million, were $168.6 million.
Cash Flows
The following table summarizes our sources and uses of cash (in thousands):

                                               Six Months Ended June 30,
                                                2021                2020

Net cash used in operating activities $ (6,634 ) $ (3,310 ) Net cash used in investing activities

                 (6 )                -
Net cash provided by financing activities         31,675                  -

Net change in cash and cash equivalents $ 25,035 $ (3,310 )





Operating Activities
Net cash used in operating activities was $6.6 million and $3.3 million for the
six months ended June 30, 2021 and 2020, respectively. Net cash used in
operating activities during the six months ended June 30, 2021 was primarily due
to our net loss of $88.4 million, which includes $81.2 million of expense
related to the change in the fair values of the Series B tranche liability and
the Series
A-1
warrant liability, plus $1.1 million of cash used for prepaid expenses
associated with research and development activities; partially offset by cash
provided of $0.7 million for both accounts payable and accrued expenses and
other current liabilities. Net cash used in operating activities during the six
months ended June 30, 2020 was primarily due to our net loss of $4.1 million,
partially offset by $0.7 million of cash provided by changes in our operating
assets and liabilities.
Investing Activities
Our cash used in investing activities for the six months ended June 30, 2021 was
de minimis and was associated with computer hardware acquired.

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Financing Activities
Net cash provided by financing activities was $31.7 million and nil for the six
months ended June 30, 2021 and 2020, respectively. Net cash provided by
financing activities during the six months ended June 30, 2021 was primarily due
to the closing of the second tranche of our Series B convertible preferred stock
for gross proceeds of $30.0 million, plus a total of $1.9 million received from
the exercise of a Series
A-1
preferred warrant, as well as exercises of common stock warrants, partially
offset by $0.2 million of costs that were paid in connection with our IPO.
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities,
particularly as we continue our research and development, conduct clinical
trials, and seek marketing approval for our current and any of our future
product candidates. Furthermore, we expect to incur additional costs associated
with operating as a public company following our July 2021 IPO. It is likely
that we will seek third-party collaborators for the future commercialization of
ACU193 or any other product candidate that is approved for marketing. However,
we may seek to commercialize our products at our own expense, which would
require us to incur significant additional expenses for marketing, sales,
manufacturing and distribution., which costs we may seek to offset through entry
into collaboration agreements with third parties. As a result, we expect that we
will need to obtain substantial additional funding in connection with our future
operations. If we are unable to raise capital when needed or on acceptable
terms, we could be forced to delay, reduce or eliminate our research and
development programs or future commercialization efforts.
Based on our current operating plan, we expect that the net proceeds from our
IPO, together with our existing cash and cash equivalents as of June 30, 2021,
will be sufficient to enable us to fund our operating expenses and capital
expenditure requirements at least through 2024. We have based this estimate on
assumptions that may prove to be wrong, and we may use our available capital
resources sooner than we currently expect. Our future capital requirements will
depend on many factors, including:

     •    the scope, progress, results and costs of discovery, nonclinical
          development, laboratory testing and clinical trials for other potential
          product candidates we may develop, if any;



     •    the costs, timing and outcome of regulatory review of our product
          candidates;



     •    our ability to establish and maintain collaborations on favorable terms,
          if at all;



     •    the achievement of milestones or occurrence of other developments that
          trigger payments under any collaboration agreements we might have at such
          time;



     •    the costs and timing of future commercialization activities, including
          product sales, marketing, manufacturing and distribution, for any of our
          product candidates for which we receive marketing approval;



     •    the amount of revenue, if any, received from commercial sales of our
          product candidates, should any of our product candidates receive
          marketing approval;



     •    the costs of preparing, filing and prosecuting patent applications,
          obtaining, maintaining and enforcing our intellectual property rights and
          defending intellectual property-related claims;



     •    our headcount growth and associated costs as we expand our business
          operations and our research and development activities; and



  •   the costs of operating as a public company.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interests may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect your rights as a common stockholder. Any debt financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. 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 candidates that we would otherwise prefer to develop and market ourselves.



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Off-Balance Sheet
Arrangements
During the periods presented we did not have, nor do we currently have,
any off-balance sheet
arrangements as defined under SEC rules.
Contractual Obligations
As of June 30, 2021, we have an operating lease obligation associated with a
lease for our executive office space that totals less than $1,000 for the
remainder of the lease term. This amount is due in equal monthly installments
over the remaining lease term, which expires on August 31, 2021.
We have been subleasing space in Indiana since March 1, 2020 under a lease that
expired on December 31, 2020. We executed a new sublease for this space that was
effective February 1, 2021. The term of the sublease is for 31 months, expiring
on August 30, 2023. We pay monthly rent of $12,719 and we are also allowing
others to sublease a portion of the space from us for less than
a one-year period.
As of June 30, 2021, the remaining aggregate minimum rent obligation over the
remaining term was approximately $331,000.
As of June 30, 2021, future minimum lease payments under lease agreements
(including short-term leases) associated with our operations were as follows (in
thousands):

Year ended December 31, 2021 (remaining 6 months) $ 77 Year ended December 31, 2022

                                153
Year ended December 31, 2023                                102

Total                                               $       332



We enter into contracts in the normal course of business with contract research
organizations ("CROs") and contract manufacturing organizations ("CMOs") for
clinical trials, nonclinical research studies and testing, manufacturing and
other services and products for operating purposes. These contracts do not
contain any minimum purchase commitments and are generally cancelable by us upon
prior notice of 30 days. Payments due upon cancelation consist only of payments
for services provided and expenses incurred up to the date of cancelation.
Critical Accounting Estimates and Policies
This management's discussion and analysis of our financial condition and results
of operations is based on our financial statements, which have been prepared in
accordance with U.S. generally accepted accounting principles, or U.S. GAAP. The
preparation of these 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 in our financial
statements. In accordance with U.S. GAAP, we evaluate our estimates and
judgments on an ongoing basis, including those related to accrued expenses, the
preferred stock tranche and warrant liabilities and stock-based compensation. We
base our estimates on historical experience, known trends and events, and
various other factors that are believed to be reasonable under the
circumstances, the results of which form the basis for making judgments about
the carrying values of assets and liabilities that are not readily apparent from
other sources. Actual results may differ from these estimates under different
assumptions or conditions.
We define our critical accounting policies as those accounting principles that
require us to make subjective estimates and judgments about matters that are
uncertain and are likely to have a material impact on our financial condition
and results of operations, as well as the specific manner in which we apply
those principles. While our significant accounting policies are more fully
described in Note 2 to our unaudited condensed financial statements located in
"Part I - Financial Information, Item 1. Financial Statements" in this Quarterly
Report on Form
10-Q.
There have been no significant changes to our critical accounting policies from
those described in "Management's Discussion and Analysis of Financial Condition
and Results of Operations," included in our final prospectus dated June 30,
2021, and filed with the SEC on July 2, 2021 pursuant to Rule 424(b)(4).

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Recent Accounting Pronouncements
See Note 2 to our unaudited condensed financial statements located in "Part I -
Financial Information, Item 1. Financial Statements" in this Quarterly Report on
Form
10-Q
for a description of recent accounting pronouncements applicable to our
financial statements.
Emerging Growth Company and Smaller Reporting Company Status
In April 2012, the Jumpstart Our Business Startups Act of 2012, or JOBS Act, was
enacted. Section 107 of the JOBS Act provides that an "emerging growth company"
can take advantage of the extended transition period provided in
Section 7(a)(2)(B) of the Securities Act of 1933, as amended, for complying with
new or revised accounting standards. Thus, an emerging growth company can delay
the adoption of certain accounting standards until those standards would
otherwise apply to private companies. We elected the extended transition period
for complying with new or revised accounting standards, which delays the
adoption of these accounting standards until they would apply to private
companies.
In addition, as an emerging growth company, we may take advantage of specified
reduced disclosure and other requirements that are otherwise applicable
generally to public companies. These provisions include:

     •    an exception from compliance with the auditor attestation requirements of
          Section 404 of the Sarbanes-Oxley Act of 2002, as amended;



     •    reduced disclosure about our executive compensation arrangements in our
          periodic reports, proxy statements and registration statements;



     •    exemptions from the requirements of holding
          non-binding
          advisory votes on executive compensation or golden parachute
          arrangements; and



     •    an exemption from compliance with the requirements of the Public Company
          Accounting Oversight Board regarding the communication of critical audit
          matters in the auditor's report on financial statements.


We may take advantage of these provisions until we no longer qualify as an
emerging growth company. We will cease to qualify as an emerging growth company
on the date that is the earliest of: (i) December 31, 2025, (ii) the last day of
the fiscal year in which we have more than $1.07 billion in total annual gross
revenues, (iii) the date on which we are deemed to be a "large accelerated
filer" under the rules of the SEC, which means the market value of our common
stock that is held by
non-affiliates
exceeds $700 million as of the prior June 30th, or (iv) the date on which we
have issued more than $1.0 billion of
non-convertible
debt over the prior three-year period. We may choose to take advantage of some
but not all of these reduced reporting burdens. We have taken advantage of
certain reduced reporting requirements in this Quarterly Report on Form
10-Q
and our other filings with the SEC. Accordingly, the information contained
herein may be different than you might obtain from other public companies in
which you hold equity interests.
We are also a "smaller reporting company," meaning that the market value of our
shares held
by non-affiliates
is less than $700 million and our annual revenue was less than $100 million
during the most recently completed fiscal year. We may continue to be a smaller
reporting company if either (i) the market value of our shares held
by non-affiliates is
less than $250 million or (ii) our annual revenue was less than $100 million
during the most recently completed fiscal year and the market value of our
shares held
by non-affiliates is
less than $700 million. If we are a smaller reporting company at the time we
cease to be an emerging growth company, we may continue to rely on exemptions
from certain disclosure requirements that are available to smaller reporting
companies. Specifically, as a smaller reporting company, we may choose to
present only the two most recent fiscal years of audited financial statements in
our Annual Report
on Form 10-K and,
similar to emerging growth companies, smaller reporting companies have reduced
disclosure obligations regarding executive compensation.

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