Log in
Log in
Or log in with
GoogleGoogle
Twitter Twitter
Facebook Facebook
Apple Apple     
Sign up
Or log in with
GoogleGoogle
Twitter Twitter
Facebook Facebook
Apple Apple     

AVIDITY BIOSCIENCES, INC.

(RNA)
  Report
Delayed Nasdaq  -  04:00:01 2023-02-07 pm EST
25.50 USD   +4.94%
09:01aAvidity Biosciences to Participate in Upcoming Investor Conference
PR
02/03Insider Sell: Avidity Biosciences
MT
01/20Avidity Biosciences Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
PR
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisionsFunds 
SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector news

AVIDITY BIOSCIENCES, INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q)

11/08/2022 | 04:27pm EST
The following discussion and analysis of our financial condition and results of
operations should be read in conjunction with our unaudited condensed financial
statements and related notes thereto included elsewhere in this quarterly report
on Form 10-Q and with our audited financial statements and notes thereto and
management's discussion and analysis of financial condition and results of
operations, both of which are contained in our annual report on Form 10-K for
the year ended December 31, 2021 filed with the Securities and Exchange
Commission, or SEC, on March 1, 2022.

Cautionary Note Regarding Forward-Looking Statements


This quarterly report contains forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange
Act. All statements other than statements of historical facts contained in this
quarterly report, including statements regarding our future results of
operations and financial position, business strategies and plans, research and
development plans, the anticipated timing, costs, design and conduct of our
ongoing and planned preclinical studies and clinical trials for our product
candidates, the timing and likelihood of resolution of the partial clinical hold
on our ongoing Phase 1/2 MARINA clinical trial, the timing and likelihood of
regulatory filings and approvals for our product candidates, the impact of
COVID-19 on our business, the timing and likelihood of success, plans and
objectives of management for future operations and future results of anticipated
product development efforts, are forward-looking statements. In some cases, you
can identify forward-looking statements by terminology such as "may," "will,"
"should," "could," "expect," "intend," "plan," "anticipate," "believe,"
"estimate," "predict," "potential," "continue," or the negative of these terms
or other comparable terminology. These forward-looking statements are only
predictions. We have based these forward-looking statements largely on our
current expectations and projections about future events and financial trends
that we believe may affect our business, financial condition and results of
operations. These forward-looking statements speak only as of the date of this
quarterly report and are subject to a number of risks, uncertainties and
assumptions, including those described in Part II, Item 1A, "Risk Factors." The
events and circumstances reflected in our forward-looking statements may not be
achieved or occur, and actual results could differ materially from those
projected in the forward-looking statements. Except as required by applicable
law, we do not plan to publicly update or revise any forward-looking statements
contained herein, whether as a result of any new information, future events,
changed circumstances or otherwise.

Overview


We are a biopharmaceutical company committed to delivering a new class of RNA
therapeutics called Antibody Oligonucleotide Conjugates, or AOCs. Our
proprietary AOC platform is designed to combine the specificity of monoclonal
antibodies, or mAbs, with the precision of RNA therapeutics to target the root
cause of diseases previously untreatable with such therapeutics. We are
initially focused on muscle diseases to demonstrate the capabilities of our
AOCs, and have three muscle programs in clinical development. Our lead product
candidate, AOC 1001, is designed to treat myotonic dystrophy type 1, or DM1, a
rare monogenic muscle disease. AOC 1001 is currently in clinical testing with
the ongoing Phase 1/2 MARINATM trial and the MARINA open label extension, or
MARINA-OLETM, trial. The U.S. Food and Drug Administration, or FDA, placed a
partial clinical hold on new participant enrollment in the Phase 1/2 MARINA
clinical trial of AOC 1001 in September 2022. All participants, whether they are
on AOC 1001 or placebo, may continue in their current dosing cohort although no
additional participants may be enrolled until the partial clinical hold is
resolved. All participants in MARINA may roll over into the MARINA-OLE where
they will receive AOC 1001. The partial clinical hold is in response to a
serious adverse event, or SAE, reported in a single participant in the 4mg/kg
cohort of the MARINA study. We are working closely with the FDA and the trial
investigator to assess the cause of this event and plan to take all necessary
steps to resolve the partial clinical hold on new participant enrollment as
quickly as possible.

In the fourth quarter of 2022, we plan to conduct a preliminary assessment of
safety, tolerability and key biomarkers in approximately half of the trial
participants from the MARINA study. The FDA and European Medicines Agency, or
EMA, have granted Orphan Designation for AOC 1001. The FDA has also granted Fast
Track Designation to AOC 1001 for the treatment of DM1.

Additionally, the FDA cleared us to proceed with Phase 1/2 trials for AOC 1020
and AOC 1044 under two INDs. AOC 1020 is designed to treat people living with
facioscapulohumeral muscular dystrophy, or FSHD, and is currently in Phase 1/2
development with the FORTITUDE™ trial.  In the first half of 2024, we plan to
conduct a preliminary assessment in approximately half of the study participants
in the FORTITUDE trial. AOC 1044, the lead of three programs for the treatment
of Duchenne muscular dystrophy, or DMD, and the first of our AOCs to deliver a
phosphorodiamidate morpholino oligomers, or PMO, is currently in Phase 1/2
development with the EXPLORE44™ trial. EXPLORE44 is designed for people with DMD

                                       19
--------------------------------------------------------------------------------


mutations amenable to exon 44 skipping. We plan to share results from the
healthy volunteers portion of the EXPLORE44 trial in the second half of 2023. We
are also broadening the development of AOCs beyond muscle tissues through both
internal discovery efforts and key partnerships that are focused on immune
cells, cardiac tissue and other cell types.

Since our inception in 2012, we have devoted substantially all of our resources
to organizing and staffing our company, business planning, raising capital,
developing our proprietary AOC platform, identifying potential product
candidates, establishing our intellectual property portfolio, conducting
research, preclinical and clinical studies, and providing other general and
administrative support for these operations. We have not generated any revenue
from product sales. In June 2020, we completed our initial public offering, or
IPO, and have since raised capital through additional public offerings, sales
agreements, convertible preferred stock/units, convertible notes, and under
collaboration and research service agreements. Refer to Liquidity and Capital
Resources for further information on the capital raised since inception and the
Company's future capital requirements.

We have incurred operating losses in each year since inception. Our net losses
were $118.0 million and $44.4 million for the years ended December 31, 2021 and
2020, respectively, and $123.5 million for the nine months ended September 30,
2022. As of September 30, 2022, we had an accumulated deficit of $308.1 million.
We expect our expenses and operating losses will increase substantially as we
conduct our ongoing and planned preclinical studies and clinical trials,
continue our research and development activities, utilize third parties to
manufacture our product candidates and related raw materials, 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 preclinical studies and clinical trials and our expenditures on other
research and development activities, as well as the generation of any
collaboration and services revenue.

Based upon our current operating plans, we believe that our existing cash, cash
equivalents and marketable securities will be sufficient to fund our operations
for at least 12 months from the date of the filing of this Form 10-Q. While we
may generate revenue under our current and/or future collaboration agreements,
we do not expect to generate any revenues from product sales until we
successfully complete development and obtain regulatory approval for one or more
of our product candidates, which we expect will take a number of years and may
never occur. If we obtain regulatory approval for any of our product candidates,
we expect to incur significant commercialization expenses related to product
sales, marketing, manufacturing and distribution. Accordingly, until such time
as we can generate significant revenue from sales of our product candidates, if
ever, we expect to finance our cash needs through equity offerings, debt
financings or other capital sources, including potential collaborations,
licenses and other similar arrangements. However, we may be unable to raise
additional funds or enter into such other arrangements when needed, on favorable
terms or at all. Our failure to raise capital or enter into such other
arrangements when needed would have a negative impact on our financial condition
and could force us 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.

COVID-19


The COVID-19 outbreak in the United States has caused significant business
disruption. The extent of the impact of COVID-19 on our operational and
financial performance will depend on certain developments, including the
continued spread of COVID-19 and the measures taken by the governmental
authorities, and its impact on our preclinical studies and clinical trials,
employees and vendors, all of which are uncertain and cannot be predicted,
particularly as we advance our product candidates into and through clinical
development. In December 2021, we transitioned to a hybrid model with our
employees generally working both remotely and onsite, and we anticipate we will
continue to use this model going forward. To date, we have not experienced
material disruptions in our business operations. However, a prolonged outbreak
could have a material adverse impact on our financial results and business
operations, including the timing of and our ability to complete certain clinical
trials and other efforts required to advance the development of our product
candidates and raise additional capital.

Research Collaboration and License Agreement with Eli Lilly and Company


In April 2019, we entered into a Research Collaboration and License Agreement,
or the Lilly Agreement, with Eli Lilly and Company, or Lilly, for the discovery,
development and commercialization of AOC products in immunology and other select
indications on a worldwide basis. Under the Lilly Agreement, we and Lilly will
collaborate on preclinical research and discovery activities for such products,
with Lilly being responsible for funding the cost of such activities by both
parties. Lilly will also lead the clinical development, regulatory approval and
commercialization of all such products, at its sole cost. We granted Lilly an
exclusive, worldwide, royalty-bearing license, with the right to sublicense,
under our technology to research, develop, manufacture, and sell products
containing AOCs that are directed to up to six mRNA targets. We retain the right
to use our technology to perform our obligations under the agreement and for all
purposes not granted to Lilly. Lilly paid us

                                       20
--------------------------------------------------------------------------------


an upfront license fee of $20.0 million in 2019, and we are eligible to receive
up to $60.0 million in development milestone payments per target, up to $140.0
million in regulatory milestone payments per target and up to $205.0 million in
commercialization milestone payments per target. We are eligible to receive a
tiered royalty ranging from the mid-single to low-double digits from Lilly on
worldwide annual net sales of licensed products, subject to specified and capped
reductions for the market entry of biosimilar products, loss of patent coverage
of licensed products and for payments owed to third parties for additional
rights necessary to commercialize licensed products in the territory.

Components of Results of Operations

Revenue


Our revenue to date has been derived from payments received under the Lilly
Agreement and other license and research collaboration agreements. For the
foreseeable future, we may generate revenue from reimbursements of services
under the Lilly Agreement, as well as a combination of upfront payments and
milestone payments under our current and/or future collaboration agreements. We
do not expect to generate any revenue from the sale of products unless and until
such time that our product candidates have advanced through clinical development
and regulatory approval, if ever. We expect that any revenue we generate, if at
all, will fluctuate from quarter-to-quarter as a result of the timing and amount
of payments relating to such services and milestones and the extent to which any
of our products are approved and successfully commercialized. If we fail to
complete preclinical and clinical development of product candidates or obtain
regulatory approval for them, our ability to generate future revenues and our
results of operations and financial position would be adversely affected.

Operating Expenses

Research and Development

Research and development expenses consist of external and internal costs associated with our research and development activities, including our discovery and research efforts, and the preclinical and clinical development of our product candidates. Our research and development expenses include:

• external costs, including expenses incurred under arrangements with third

parties, such as contract research organizations, contract manufacturers,

      consultants and our scientific advisors; and


  • internal costs, including;

o employee-related expenses, including salaries, benefits and stock-based

         compensation;


      o  the costs of laboratory supplies and acquiring, developing and
         manufacturing preclinical study materials; and

o facilities, information technology and depreciation, which include direct

and allocated expenses for rent and maintenance of facilities and

depreciation of leasehold improvements and equipment.



Research and development costs, including costs reimbursed under the Lilly
Agreement, are expensed as incurred, with reimbursements of such amounts being
recognized as revenue. We account for nonrefundable advance payments for goods
and services that will be used in future research and development activities as
expenses when the service has been performed or when the goods have been
received.

At any one time, we are working on multiple programs. Our internal resources,
employees and infrastructure are not directly tied to any one research or drug
discovery program and are typically deployed across multiple programs. As such,
we do not track internal costs on a specific program basis. The following table
summarizes our external costs and internal costs for the periods presented (in
thousands):

                                             Three Months Ended September 

30, Nine Months Ended September 30,

                                                2022                  2021              2022               2021
External costs                             $        20,516       $        13,986     $   59,224       $       38,667
Internal costs:
Employee-related expenses                           12,299                 8,558         33,472               22,593
Facilities, lab supplies and other costs             4,502                 2,287         12,098                6,954
Total internal costs                                16,801                10,845         45,570               29,547

Total research and development expenses $ 37,317 $ 24,831 $ 104,794 $ 68,214

                                       21
--------------------------------------------------------------------------------




We expect our research and development expenses to increase for the foreseeable
future as we continue to conduct our ongoing research and development
activities, advance our preclinical research programs toward clinical
development, including conducting IND-enabling studies, and conduct clinical
trials. The process of conducting preclinical studies and clinical trials
necessary to obtain regulatory approval is costly and time consuming. We may
never succeed in achieving marketing approval for any of our product candidates.

The timelines and costs associated with research and development activities are
uncertain, can vary significantly for each product candidate and development
program, and are difficult to predict. We anticipate we will make determinations
as to which programs to pursue and how much funding to direct to each program on
an ongoing basis in response to preclinical and clinical results, regulatory
developments, ongoing assessments as to each program's commercial potential, and
our ability to maintain or enter into new collaborations, to the extent we
determine the resources or expertise of a collaborator would be beneficial for a
given program. We will need to raise substantial additional capital in the
future. In addition, we cannot forecast which development programs may be
subject to future collaborations, when such arrangements will be secured, if at
all, and to what degree such arrangements would affect our development plans and
capital requirements.

Our development costs may vary significantly based on factors such as:

• the number and scope of clinical, preclinical and IND-enabling studies;

• the timing and likelihood of resolution of the partial clinical hold on our

      ongoing Phase 1/2 MARINA clinical trial;


  • 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 length of time required to enroll eligible patients;


  • the number of patients that participate in the trials;


  • the number of doses that patients receive;


  • the drop-out or discontinuation rates of patients;

• potential additional safety monitoring requested by regulatory agencies;


  • the duration of patient participation in the trials and follow-up;


  • the cost and timing of manufacturing our product candidates;


  • the phase of development of our product candidates; and


  • the efficacy and safety profile of our product candidates.

General and Administrative


General and administrative expenses consist primarily of employee-related
expenses, including salaries, benefits and stock-based compensation, for
employees in our executive, finance, accounting, legal, business development and
support functions. Other general and administrative expenses include allocated
facility, information technology and depreciation related costs not otherwise
included in research and development expenses and professional fees for
auditing, tax, intellectual property and legal services. Costs related to filing
and pursuing patent applications are recognized as general and administrative
expenses as incurred since recoverability of such expenditures is uncertain.

We expect our general and administrative expenses will increase for the foreseeable future to support our increased research and development and other corporate activities.


Other Income (Expense)

Other income (expense) consists primarily of interest earned on our cash, cash equivalents and marketable securities.

                                       22
--------------------------------------------------------------------------------

Results of Operations

Comparison of the Three Months Ended September 30, 2022 and 2021

The following table summarizes our results of operations for the periods presented (in thousands):


                                                  Three Months Ended 

September 30, Increase

                                                     2022                  2021            (decrease)
Revenue                                         $         2,482       $         2,163     $        319
Research and development expenses                        37,317                24,831           12,486
General and administrative expenses                      10,094                 6,612            3,482
Other income                                              1,330                     6            1,324




Revenue

Revenue was $2.5 million for the three months ended September 30, 2022 compared
to $2.2 million for the three months ended September 30, 2021. Revenue during
both periods was primarily derived from the Lilly Agreement. The increase was
primarily due to an increase of reimbursable internal costs driven by an
increase in labor rates.

Research and Development Expenses


Research and development expenses were $37.3 million for the three months ended
September 30, 2022 compared to $24.8 million for the three months ended
September 30, 2021. External costs increased by $6.5 million and was primarily
driven by contract services, manufacturing, and costs related to the progression
of clinical trials and preclinical studies in the following programs: $1.2
million increase in costs related to the AOC 1001 program, a $0.4 million
increase in costs related to the AOC 1020 program, $1.8 million increase in
costs related to other potential programs, and $5.5 million in indirect costs
primarily for the manufacture of antibodies, partially offset by a $2.4 million
decrease in costs related to the AOC 1044 program consistent with the stage of
the study.

Internal costs increased by $6.0 million driven by a $3.7 million increase of
employee-related expenses, including $2.0 million for salaries and benefits and
$1.7 million for stock-based compensation, both due to increased headcount, and
a $2.3 million increase of costs related to lab supplies and facilities costs.

General and Administrative Expenses


General and administrative expenses were $10.1 million for the three months
ended September 30, 2022 compared to $6.6 million for the three months ended
September 30, 2021. The increase was primarily due to higher personnel costs,
including $0.7 million for salaries and benefits and $0.8 million for
stock-based compensation, and $1.4 million in professional fees to support our
expanded operations.

Other Income

Other income was $1.3 million for the three months ended September 30, 2022
compared to $6.0 thousand for the three months ended September 30, 2021. The
increase was primarily driven by higher interest income earned on marketable
securities investments.

Comparison of the Nine Months Ended September 30, 2022 and 2021

The following table summarizes our results of operations for the periods presented (in thousands):


                                                   Nine Months Ended 

September 30, Increase

                                                      2022                  2021           (decrease)
Revenue                                         $          6,455       $        7,474     $     (1,019 )
Research and development expenses                        104,794               68,214           36,580
General and administrative expenses                       27,349               18,764            8,585
Other income                                               2,164                   33            2,131


                                       23
--------------------------------------------------------------------------------

Revenue


Revenue was $6.5 million for the nine months ended September 30, 2022 compared
to $7.5 million for the nine months ended September 30, 2021. Revenue during
both periods was primarily derived from the Lilly Agreement. The change was
primarily due to a decrease in direct reimbursable collaboration-related
expenses resulting in lower corresponding revenue under the Lilly Agreement.

Research and Development Expenses


Research and development expenses were $104.8 million for the nine months ended
September 30, 2022 compared to $68.2 million for the nine months ended
September 30, 2021.The increase was primarily driven by the $20.6 million
increase in external costs associated with upfront license costs, contract
services, increased product development costs and clinical costs related to the
progression of clinical trials and preclinical studies in the following
programs: a $6.1 million increase in costs related to the AOC 1020 program, $8.8
million increase in costs related to other potential programs, and $12.5 million
in indirect costs primarily for the manufacture of antibodies, partially offset
by a $3.8 million decrease in costs related to the AOC 1001 program consistent
with the clinical stage and a $3.0 million decrease in costs related to the AOC
1044 program.

Internal costs increased by $16.0 million driven by a $10.9 million increase in
employee-related expenses, including $6.9 million for salaries and benefits and
$4.0 million for stock-based compensation, both due to increased headcount, and
a $5.1 million increase of costs related to lab supplies and facilities costs.

General and Administrative Expenses


General and administrative expenses were $27.3 million for the nine months ended
September 30, 2022 compared to $18.8 million for the nine months ended
September 30, 2021. The increase was primarily due to higher personnel costs,
including $1.5 million for salaries and benefits and $3.3 million for
stock-based compensation, and $2.2 million in professional fees to support our
expanded operations.


Other Income

Other income was $2.2 million for the nine months ended September 30, 2022 compared to $33 thousand for the nine months ended September 30, 2021. The increase was primarily driven by higher interest income earned on marketable securities investments.

Liquidity and Capital Resources

Sources of Liquidity


In June 2020, we completed our IPO of 16,560,000 shares of our common stock at a
price to the public of $18.00 per share, including the exercise in full by the
underwriters of their option to purchase 2,160,000 additional shares of our
common stock. Including the option exercise, our aggregate net proceeds from the
offering were $274.1 million, net of underwriting discounts, commissions and
offering costs. In August 2021, we completed a public offering of 9,200,000
shares of our common stock at a public offering price of $18.00 per share, for
aggregate net proceeds of $155.1 million, after deducting underwriting
discounts, commissions and offering costs.

In July 2021, we entered into a sales agreement, or the 2021 Sales Agreement,
with Cowen and Company, LLC, or the Sales Agent, under which we may, from time
to time, sell shares of common stock having an aggregate offering price of up to
$150.0 million through the Sales Agent. Through September 30, 2022, we have sold
7,141,761 shares of our common stock pursuant to the 2021 Sales Agreement and
received net proceeds of $121.3 million, after deducting offering-related
transaction costs and commissions. From October 1, 2022 through November 8,
2022, we sold 1,410,600 shares of our common stock pursuant to the 2021 Sales
Agreement and received net proceeds of $19.4 million, after deducting
offering-related transaction costs and commissions. Since our inception through
September 30, 2022, other significant sources of capital raised to fund our
operations were comprised of aggregate gross proceeds of $131.6 million from the
sale and issuance of convertible preferred stock/units and convertible notes and
$38.1 million from funding under collaboration and research services agreements.

On November 8, 2022, we entered into a new sales agreement, or the 2022 Sales
Agreement, with the Sales Agent, with substantially similar terms as the 2021
Sales Agreement described above. Under the 2022 Sales Agreement, we may, from
time to time, sell shares of our common stock having an aggregate offering price
of up to $200.0 million through the Sales Agent.

                                       24
--------------------------------------------------------------------------------

Future Capital Requirements


As of September 30, 2022, we had cash, cash equivalents and marketable
securities of $405.5 million. Based upon our current operating plans, we believe
that our existing cash, cash equivalents and marketable securities will be
sufficient to fund our operations for at least 12 months from the date of the
filing of this Form 10-Q. However, our forecast of the period of time through
which our financial resources will be adequate to support our operations is a
forward-looking statement that involves risks and uncertainties, and actual
results could vary materially. We have based this estimate on assumptions that
may prove to be wrong, and we could deplete our capital resources sooner than we
expect. Additionally, the process of conducting preclinical studies and testing
product candidates in clinical trials is costly, and the timing of progress and
expenses in these studies and trials is uncertain.

Our future capital requirements are difficult to forecast and will depend on many factors, including but not limited to:

• the type, number, scope, progress, expansions, results, costs and timing of

discovery, preclinical studies and clinical trials of our product candidates

that we are pursuing or may choose to pursue in the future;

• the costs and timing of manufacturing for our product candidates and

commercial manufacturing if any product candidate is approved;

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

• the terms and timing of establishing and maintaining collaborations,

licenses and other similar arrangements;

• the costs of obtaining, maintaining and enforcing our patents and other

intellectual property rights;

• the costs associated with hiring additional personnel and consultants as our

preclinical and clinical activities increase;

• the timing and amount of the milestone or other payments made to us under

the Lilly Agreement or any future collaboration agreements;

• the costs and timing of establishing or securing sales and marketing

capabilities if any product candidate is approved;

• 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

• costs associated with any products or technologies that we may in-license or

acquire.



While we may generate revenue under our current and/or future collaboration
agreements, we do not expect to generate any revenues from product sales until
we successfully complete development and obtain regulatory approval for one or
more of our product candidates, which we expect will take a number of years and
may never occur. If we obtain regulatory approval for any of our product
candidates, we expect to incur significant commercialization expenses related to
product sales, marketing, manufacturing and distribution. Accordingly, until
such time as we can generate significant revenue from sales of our product
candidates, if ever, we expect to finance our cash needs through equity
offerings, debt financings or other capital sources, including current and
potential future collaborations, licenses and other similar arrangements.
However, we may be unable to raise additional funds or enter into such other
arrangements when needed, on favorable terms or at all. In addition, we may seek
additional capital due to favorable market conditions or strategic
considerations even if we believe we have sufficient funds for our current or
future operating plans. Our failure to raise capital or enter into such other
arrangements when needed would have a negative impact on our financial condition
and could force us 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.

                                       25
--------------------------------------------------------------------------------

Cash Flows


The following table summarizes our cash flows for the periods presented (in
thousands):

                                                            Nine Months Ended September 30,
                                                              2022                   2021
Net cash provided by (used in):
Operating activities                                    $         (97,079 )     $       (68,598 )
Investing activities                                             (182,187 )               1,547
Financing activities                                              102,517               155,602

Net (decrease) increase in cash, cash equivalents

  and restricted cash                                   $        (176,749 )     $        88,551




Operating Activities

Net cash used in operating activities was $97.1 million for the nine months
ended September 30, 2022, which consisted primarily of cash used to fund our
operations related to the development of AOC 1001, AOC 1044, AOC 1020 and other
potential programs. Net cash used in operating activities was $68.6 million for
the nine months ended September 30, 2021, which consisted primarily of cash used
to fund our operations related to the development of AOC 1001, AOC 1044 and AOC
1020. The change in cash used in operating activities is due to increased
research and development costs as well as general and administrative expenses as
described under "Results of Operations" above.

Investing Activities


Net cash used in investing activities was $182.2 million for the nine months
ended September 30, 2022, which consisted of $266.2 million for purchases of
marketable securities and $2.0 million in purchases of property and equipment
partially offset by $86.0 million of proceeds from maturities of marketable
securities. Net cash provided by investing activities was $1.55 million for the
nine months ended September 30, 2021, which consisted of proceeds of $3.58
million from maturities of marketable securities, partially offset by cash used
to purchase $2.03 million of property and equipment.

Financing Activities


Net cash provided by financing activities was $102.5 million for the nine months
ended September 30, 2022, which consisted primarily of net proceeds from sales
of our common stock made pursuant to the Sales Agreement. Net cash provided by
financing activities was $155.6 million for the nine months ended September 30,
2021, which consisted primarily of proceeds from the issuance of common stock in
the August 2021 public offering.

Critical Accounting Policies and Estimates


Our management's discussion and analysis of our financial condition and results
of operations is based on our condensed financial statements, which have been
prepared in accordance with U.S. generally accepted accounting principles, or
GAAP. The preparation of these condensed financial statements requires us to
make estimates and judgments that affect the reported amounts of assets,
liabilities, revenue and expenses. On an ongoing basis, we evaluate these
estimates and judgments. We base our estimates on historical experience and on
various assumptions that we believe to be reasonable under the circumstances.
These estimates and assumptions form the basis for making judgments about the
carrying values of assets and liabilities and the recording of revenue and
expenses that are not readily apparent from other sources. Actual results may
differ materially from these estimates. As of September 30, 2022, there have
been no material changes to our critical accounting policies and estimates from
those disclosed in "Management's Discussion and Analysis of Financial Condition
and Results of Operations - Critical Accounting Policies and Estimates,"
included in our annual report on Form 10-K for the year ended December 31, 2021
filed with the SEC on March 1, 2022.

Contractual Obligations and Commitments


As of September 30, 2022, there have been no material changes outside the
ordinary course of our business to the contractual obligations we reported in
"Management's Discussion and Analysis of Financial Condition and Results of
Operations - Contractual Obligations and Commitments," included in our annual
report on Form 10-K for the year ended December 31, 2021 filed with the SEC on
March 1, 2022.

                                       26

--------------------------------------------------------------------------------

© Edgar Online, source Glimpses

All news about AVIDITY BIOSCIENCES, INC.
09:01aAvidity Biosciences to Participate in Upcoming Investor Conference
PR
02/03Insider Sell: Avidity Biosciences
MT
01/20Avidity Biosciences Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
PR
01/18Avidity Biosciences Says it Received FDA's Fast Track Designation for AOC 1020 to Treat..
MT
01/18Avidity Biosciences Gets FDA Fast-Track Designation for AOC 1020
DJ
01/18Avidity Biosciences Granted FDA Fast Track Designation for AOC 1020 for the Treatment o..
PR
01/18Avidity Biosciences Granted FDA Fast Track Designation for AOC 1020 for the Treatment o..
CI
01/06Avidity Biosciences : January 2023 Corporate Presentation
PU
01/04Wells Fargo Adjusts Price Target on Avidity Biosciences to $55 From $60, Maintains Over..
MT
01/03Insider Sell: Avidity Biosciences
MT
More news
Analyst Recommendations on AVIDITY BIOSCIENCES, INC.
More recommendations